Moderna

Cardiovascular symptom reports

Female, 60 - 75 years

Age Reported Symptoms Notes
60 2021-01-01 palpitations increase warmth, pain at injection site, aching of entire left arm, then aching of neck, shoulders... Read more
increase warmth, pain at injection site, aching of entire left arm, then aching of neck, shoulders, back, hips, legs, headache by 7pm same day of injection. By 10pm, shaking chills, severe aching all over body, bad headache. Had taken aleve and omeprazole by 7pm with supper as per usual routine. At 10pm I took tylenol 650mg and cyclobenzaprine 2.5mg and crawled into bed. Slept 2 hours, woke without shaking but head throbbing, nose congested more, body still very achey, and heart pounding. This went on rest of night and all next am. temp at 10am 1/2/21 100.8 orally. Had not taken it before that. Took 2 aleve, drank glass water & ate toast. Slept til around 2pm. temp then 100.4. less achey in back, legs but arm still very sore and headache, hips hurt and neck hurt. Slowly better overnight to 2/2/21 but still not over headache, arm pain, neck ache and hip pain. All are less, however.
60 2021-01-03 hypertension Approximately 8 mins after injection, I began to experience lightheadedness and trouble focusing. B... Read more
Approximately 8 mins after injection, I began to experience lightheadedness and trouble focusing. Began to feel dizzy, weak, was sweating, and had a flushed appearance in face. On attempt to stand, felt like I could not take a step. In ER vitals were normal except for blood pressure was high. Was discharged after receiving IV fluids, lab tests, EKG. About 5 hours later, I developed a low grade fever of 99.7, blood pressure 142/92, chills, general malaise and body aches. Symptoms started dissipating later in the evening. Started feeling better as the day progressed the next day.
60 2021-01-05 chest discomfort Client received vaccine at approximately 3:50pm, waited in observational area x30min. Left with husb... Read more
Client received vaccine at approximately 3:50pm, waited in observational area x30min. Left with husband, stated that she got a few miles down the road and starting experiencing tightness in her chest and flushing. She took 50 mg of Benadryl, 30mg of prednisone and two puffs on her inhaler. She returned to the clinic, upon assessment from nursing she looked extremely flushed and anxious, she stated that she still felt tightness and that she had a history of anaphylaxis once before and had used an epi pen in the past. She had an epi pen with her and questioned whether or not she should give it to herself. BP was 190/68, pulse was normal, respirations normal, she continued to experience tightness and "not able to catch my breath", encouraged to use epi pen. She administered epi pen to right thigh at approximately 4:45PM, 911 called. Within a few minutes, she stated she was feeling better, less tightness in the chest, flushing was subsiding. BP at 190/70 at 4:52. EMS on scene at 5:03pm. Vitals normal , EKG normal. Client decided not to transport with EMS.
60 2021-01-06 blood glucose increased Patient presented to the ED with c/o of injection site reaction of firmness approximately baseball s... Read more
Patient presented to the ED with c/o of injection site reaction of firmness approximately baseball sized to the left deltoid and redness. This is not what triggered the visit. The reason for the visit was that she felt itchy all over, and this started at approximately 4:30 pm. Patient was given IV normal saline, benadryl 50 mg IM and Pepcid 20 mg IV. Patient had significant improvement in itching and was discharged from the ED at 6:10 pm.
60 2021-01-06 chest discomfort "Hot, flushing. took Benadryl liquid several doses, chest tightness and shortness of breath, resolve... Read more
"Hot, flushing. took Benadryl liquid several doses, chest tightness and shortness of breath, resolved by next morning"
60 2021-01-06 chest discomfort "Hot, flushing, took Benadryl liquid po several doses, i had chest tightness and could not take a fu... Read more
"Hot, flushing, took Benadryl liquid po several doses, i had chest tightness and could not take a full breath until the next morning"
60 2021-01-07 chest discomfort First, let me say that I had a diagnosed case of Coronavirus in April of 2020 last year. I woke up ... Read more
First, let me say that I had a diagnosed case of Coronavirus in April of 2020 last year. I woke up about 12 hours - at about 3 or 3:30am - after receiving the vaccine to my teeth chattering and feeling like I was freezing. It felt about the same as it did when I have Coronavirus before. My head was hurting like a tension headache, I had a slight buzz in my ears, my neck, shoulders, back all hurt (body aches). I felt pressure in my chest but unlike when I had the virus, I could still breathe. Eventually instead of freezing, I got hot and my temperature went to 101.9. I checked it several times with 3 different thermometers. I became dehydrated quickly which I realized because I kept going to the bathroom. My niece brought me Gatorade which helped. I also took Naprxin 500mg. On Thursday morning I felt better. Now what remains to oday, Friday, 1/8 is a sore arm that feels HOT to the touch at the injection site. I admit I am not looking forward to Moderna shot #2. It gave me flashbacks of the Virus I suffered through for a month before being able to get a test and another month afterward from March 6 when I think I contracted it through May 15 when I tested negative. I wish I understood why this happened to me and if it will happen again. I am reporting this because my Test was arraigned via my job and my CIO said I should. A friend who I happened to see at the test site who tested a few patients after me has zero negative effects.
60 2021-01-07 fainting RespDepression, CoughWheeze & Syncope Narrative: Patient started having shortness of breath about 20... Read more
RespDepression, CoughWheeze & Syncope Narrative: Patient started having shortness of breath about 20 minutes after injection. First reported as a cough then asked for water and was having difficulty breathing.
60 2021-01-08 cardiac failure congestive, chest discomfort Patient received the Moderna COVID-19 vaccine at her place of employment as a phase 1A essential fro... Read more
Patient received the Moderna COVID-19 vaccine at her place of employment as a phase 1A essential frontline healthcare worker in a skilled nursing LTC facility on January 6 2021. The day after receiving the vaccine (1-7-21), she started to feel increased shortness of breath (she has shortness of breath at baseline due to chronic health conditions- CHF, asthma), a heavy feeling in her chest/lungs, sweating and fatigue. She contacted the pharmacy on January 8th, as we were the entity that vaccinated her to ask about vaccine reaction. Due to her medical history of MI and CHF, pharmacist did not want to dismiss this as a reaction to the vaccine, and recommended that she contact her doctor for further guidance. She did reach out to her care team, and ended up going to the emergency room for testing due to cardiac history and presentation of symptoms. She had diagnostic testing done (see item 19) and the ER doctor attributed her symptoms to an exacerbation of CHF and asthma, noting that vaccine involvement in the worsening of her symptoms can not be ruled out. Treatment/discharge instructions include: follow up with cardiology/pulmonology, furosemide dose was increased, potassium supplement restarted, and instructed to use inhalers already on hand when needed. As of time of report on January 9 2021, the patient was resting at home, doing well except still having symptoms upon exertion.
60 2021-01-08 fainting Dizziness, NauseaVomiting, severe vertigo, vomiting and diarrhea, weakness Narrative: dizziness sta... Read more
Dizziness, NauseaVomiting, severe vertigo, vomiting and diarrhea, weakness Narrative: dizziness started approx 2 hours after vaccine was administered. that evening, experienced severe vertigo and weakness, vomiting and diarrhea and collapsed on the bathroom floor. took some benadryl. next day could not get out of bed due to dizziness and weakness. have since recovered.
60 2021-01-08 fast heart rate, palpitations Tachycardia c/o "SOB, heart racing, HR increases with exertion. HR @ 104. Narrative: Staff was ins... Read more
Tachycardia c/o "SOB, heart racing, HR increases with exertion. HR @ 104. Narrative: Staff was instructed to monitor HR and if symptoms persisted or worsen staff was instructed to go to nearest ER. Staff member was instructed may leave work if unable to perform duties due to elevated HR. Staff stated," I have one more patient to see now then one after that. I will see if i need to go home and let you know if i leave work. I will go to the ER if my heart rate gets higher or if i get chest pain." Instructed staff member I would await her decision.
60 2021-01-09 blood pressure increased Side effects: Elevated blood pressure 208/96 & 204/94. Dizziness. Headache/heaviness in the head. ... Read more
Side effects: Elevated blood pressure 208/96 & 204/94. Dizziness. Headache/heaviness in the head. Treatment: Went to emergency room on 1/3/2021. Increased blood pressure medication (DILTIAZEM) to 300mg and added another one (HYDRALAZINE) 25mg 3 times a day. Which my primary physician increased to 4 times a day,. Outcome: Lower blood pressure with occasional spikes to the borderline.
60 2021-01-10 excessive bleeding It bled a little, right away I felt jittery. Later that night I got chills, and I had to change my s... Read more
It bled a little, right away I felt jittery. Later that night I got chills, and I had to change my shirt twice because I was drenched in sweat. The morning I had a head ache and just felt achy, my arm was very painful. I was able to sit down and run some errands. I was feeling sick like when you have flu. The 26th I felt the same, the 27th I felt the same and my arm was hurting and the injections site was red and very big. On the 28th I decided to go to the Urgent Care. The Dr told me I had an infection on my arm, he gave me an antibiotic shot for the infection and another shot for the pain. I continued taking antibiotics and Benadryl and was feeling much better by Wednesday and my arm swelling went away. I had Covid in October and Urgent care saved my life, I love going there.
60 2021-01-10 heart rate increased Moderna COVID-19 Vaccine EUA Within first 15 minutes after vaccination, patient experienced flushi... Read more
Moderna COVID-19 Vaccine EUA Within first 15 minutes after vaccination, patient experienced flushing of the left arm. Within 1 hour patient experienced feverish feelings, rapid pulse, transient nausea and then hives/blistering on the left neck arm and back. Patient took Benadryl and Zyrtec daily times 2 days following vaccination.
60 2021-01-12 chest discomfort pt had tightness in her chest and shortness of breath. BP-122/84, O2sat-99%, Pulse 102
60 2021-01-12 hypertension, fast heart rate Lightheadedness following by persistent tachycardia with heart rate up to 137 and hypertensive BP re... Read more
Lightheadedness following by persistent tachycardia with heart rate up to 137 and hypertensive BP readings up to 165/90, 152/105 with positive orthostatic pulse change from 116 sitting to 137 standing . Ox sat 98%. Slightly increased work of breathing. Paramedics called.
60 2021-01-13 blood pressure increased angioedema within 15' : tongue swelling, difficulty talking, increased BP : transferred to ED & tx ... Read more
angioedema within 15' : tongue swelling, difficulty talking, increased BP : transferred to ED & tx with H1, H2 with sx resolution . Observed 6 hrs and d/c to home
60 2021-01-13 chest pain Day 1 Severe headache (tylenol), Day 2 and 3 Sore left arm and general myalgias (ibuprofen), Day 4 ... Read more
Day 1 Severe headache (tylenol), Day 2 and 3 Sore left arm and general myalgias (ibuprofen), Day 4 Fatigue, headache, chest pain, severe nausea, abdominal pain, lack of appetite, myalgias (rest and fluids) Day 7 Severe watery diarrhea, nausea, low grade temp, headache, abdominal cramping, sore throat, myalgias (fluids, immodium, tylenol)
60 2021-01-13 oxygen saturation decreased Patient experienced low O2 saturations (88-90%) and shortness of breath on 1/7/21 in the evening tha... Read more
Patient experienced low O2 saturations (88-90%) and shortness of breath on 1/7/21 in the evening that improved with benadryl. Continued shortness of breath on 1/8 and 1/9/21 and reported to Urgent Care on 1/9/21. Was diagnosed with allergic reaction.
60 2021-01-14 chest discomfort By 9 pm I had fever 100, body aches, chills, soreness at injection site, headache, mild chest tightn... Read more
By 9 pm I had fever 100, body aches, chills, soreness at injection site, headache, mild chest tightness, mild dry cough, nausea. The next morning fever was 101. Symptoms continued through next 24hours but were manageable with Tylenol and ibuprofen. The next morning mild headache remained. It should be noted that I did have covid19 on November 10.
60 2021-01-14 hypertension Approx 40 post injection, c/o flushing HTN 203/105. Transitioned to ED.
60 2021-01-14 palpitations This patient received her first dose of Moderna vaccine and was then sent to the observation area. W... Read more
This patient received her first dose of Moderna vaccine and was then sent to the observation area. Within 10 minutes of vaccine receipt, she began complaining of a fast heart beat and some tightness in the throat. Emergency services was called immediately and she was placed supine in a stretcher. Her initial vitals were: heart rate of 130 beats/minute and oxygen saturation of 95%. Repeated vitals were as follows: 11:25- BP 162/94,HR 123, SO2- 98% 11:30- BP 161/81 HR 101, SO2- 96% 11:35- BP 160/106 HR 95, SO2- 96% 11:35 - BP 157/96 HR 96, SO2- 95% complaining of tingling in fingers. 11:40- BP 162/79 HR 91, SO2- 96% 11:45- BP 152/84HR 92, SO2- 95% denies chest pain, shortness of breath, or throat tightness at this time. Patient felt better within 20 minutes and was taken to the emergency department for evaluation. In the emergency department, she was encouraged to obtain the remainder of the work up but declined and elected to go home. She denied rashes, respiratory distress, or itching at the time of discharge from the emergence department. She planned to follow up with her outpatient primary care provider.
60 2021-01-15 blood pressure increased Extremely high blood pressure - 255/150, flushed face. BP was checked 35 minutes after administering... Read more
Extremely high blood pressure - 255/150, flushed face. BP was checked 35 minutes after administering the vaccine. It took 4 hours to come down to 175/90 and I was sent home from ER. After 14.5 hours, BP came down to 135/78. I was given 1 pill of Benadryl in the ER.
60 2021-01-15 heart rate increased Itching in legs, arms, tingling in lips, mouth, tongue. Heart rate increased.
60 2021-01-17 chest discomfort at 3 am I started to feel muscle ache, headache, weakness, i felt as if i couldn't breath for a lit... Read more
at 3 am I started to feel muscle ache, headache, weakness, i felt as if i couldn't breath for a little bit, my chest felt tight for about 5 minutes, I could not breath . The next day i couldn't go to work due to heavy weakness, still had muscle ache. I also had mucus coming of my nose for 2 days as if i had rhinitis.
60 2021-01-17 heart rate abnormal, blood pressure increased Rapid heart rate and increase in blood pressure, excessive thirst
60 2021-01-17 fast heart rate Called to see pt in drive up lane 4 min post vaccination. She immediately felt after the vaccination... Read more
Called to see pt in drive up lane 4 min post vaccination. She immediately felt after the vaccination, numbness and tingling of face, tongue, throat. Past med history of rheumatoid arthritis and HTN. Possible allergy to Benadryl and Demoral. Initial examination lungs CTA, regular tachycardia. Swelling of lips, and tongue, uvula midplane, not deviated. Pt moved to observation area. Initial vitals: BP: 185/87, HR 128, RR 20, 100% O2 at 10:25 EMS notified and first injection 3mg Epi pen injection given at 10:23am; 911 called. BP: 185/87, HR 128, RR 20, 100% O2 at 10:25. Second epinephrine 3mg injection given at 10:26am. BP 185/87, HR 134, O2 sat 100% at 10:29am. Benadryl 50 mg po given at 10:29am. Next dose of epi given at 10:34 failed, 4th dose given at 10:35am. EMS arrived and she was taken to hospital at 10:45.
60 2021-01-18 blood pressure increased I had the vaccine and shortly after my left arm was very sore, tender to the touch. The pain was fro... Read more
I had the vaccine and shortly after my left arm was very sore, tender to the touch. The pain was from my elbow radiating up into my neck and head causing a severe headache on my left side of my head. I had chills with no fever and felt nauseated. I went to work the following morning, I still had soreness in my left arm, headache and some chills, even after Tylenol. About two hours into my work my chills went to sweating Perfusely, the pain in my arm was increased from the elbow into my neck and head. My headache made me feel nauseated and light headed. My heart started beat harder and I had a hard time breathing. My BP was 164/122 and my pulse was 190. I was checked by a PA and my supervisor. I was sent home. At home I had to monitor my BP and felt fatigued The Who,e day along with my other symptoms. They lasted for 24-26 hours.
60 2021-01-18 palpitations Patient stated she was having heart palpitations and SOB. She was taken to the ED and all tests were... Read more
Patient stated she was having heart palpitations and SOB. She was taken to the ED and all tests were normal, no palpitations and oxygen sats were in the normal range. Anxiety attack.
60 2021-01-18 fast heart rate After the shot my left arm became sore and tender. Later my arm had pain from my elbow radiating up ... Read more
After the shot my left arm became sore and tender. Later my arm had pain from my elbow radiating up into my neck and head causing a massive headache on the left side of my head. I had chills with NO fever. I felt nauseated. I went to work the following day with all of the previous symptoms. I experienced sweats along with the chilling and light headed ness. I started to experience tachycardia. My supervisor on my floor took my blood pressure and it was 164/122 and my pulse rate was 190. A PA was available and examined me and asked if I had caffeine which I didn?t. After sitting and being re-examined my blood pressure was 142/100, and my pulse was 90. I was sent home. At home I still experienced the headache and was fatigued, and my arm was still sore and tender. This happened within 24-25 hours after receiving the vaccine. Today my arm is slightly sore and I still have a headache but it is not as severe as previous.
60 2021-01-20 chest discomfort, chest pain Strong Heavy chest pain and chest tightening. I thought I was going to die.
60 2021-01-20 chest pain Chest pain and shortness of breath
60 2021-01-20 chest pain Shortness of breath and chest pain
60 2021-01-20 palpitations Patient had a heart rate above 100 for more than a minute. then went back to normal. patient did not... Read more
Patient had a heart rate above 100 for more than a minute. then went back to normal. patient did not faint.
60 2021-01-23 chest discomfort 3 hrs after vaccine, 4 hrs after 50 mg Benadryl & 20 mg Famotadine I had chest pressure and couldn't... Read more
3 hrs after vaccine, 4 hrs after 50 mg Benadryl & 20 mg Famotadine I had chest pressure and couldn't tell if I was having trouble breathing and heart rate was 112. I took another 50 mg Benadryl, 20 mg Famotadine and added 240 mg Magnesium 4 hrs after initial dose. 3 hrs later pulse came down to the 90s. I had chest pressure for 3 days after but couldn't tell if it was asthma, allergy or gerd or a reaction to the vaccine.
60 2021-01-23 palpitations Within 3 min of injection - lightheaded, racing heart beat. Increased PAC sensation. Strong metallic... Read more
Within 3 min of injection - lightheaded, racing heart beat. Increased PAC sensation. Strong metallic taste.. HR/PACs resolved mainly within 10-15 min. Lightheaded, extreme fatigue and metallic taste eased after about 45 min.
60 2021-01-24 loss of consciousness Immediate swelling and soreness at injection site. After 3 hours soreness spread to elbow and neck. ... Read more
Immediate swelling and soreness at injection site. After 3 hours soreness spread to elbow and neck. I was tired and muscle hurt, and a little dizzy for the next few days. Third day after injection, had an adverse event, severe dizziness and disorientation. Almost lost consciousness several times, but did not. Mental thought process was affected. Had sensation of not receiving enough oxygen. Severe diarrhea and sick to my stomach, sinus congestion. Episode lasted several hours, next 24 hours was dizzy, weak, and soreness of arm. Had another slight episode of dizziness, sinus congestion, tiredness, and chills on day 11 after the vaccine.
60 2021-01-25 cerebrovascular accident Woke up the next morning with slurred speech, right side weakness, illegible writing, balance issues... Read more
Woke up the next morning with slurred speech, right side weakness, illegible writing, balance issues. Next day all symptoms worse. Went to Urgent Care, was transferred to Hospital. Diagnosed with stroke.
60 2021-01-25 loss of consciousness Woke up at 2:00am dizzy, headache, nausea , vomiting and eventually fell unconscious.
60 2021-01-25 palpitations, loss of consciousness Moderna COVID-19 Vaccine EUA 1/23/21: in the night, experied: fever; chills; fatigue; ;muscle pain; ... Read more
Moderna COVID-19 Vaccine EUA 1/23/21: in the night, experied: fever; chills; fatigue; ;muscle pain; body aches; diarrhea; dizziness; headache, and passed out twice. 1/24/21: chills, muscle pain, weak, fatigue, light headed 1/25/21: unable to go to work (teacher): ongoing fatigue, feeling wrung from intensity of reaction; 11:00 pm - heart racing; chills 1/26/21: back to work; stablizing; arm still very sore
60 2021-01-25 palpitations received covid 19 vaccine 12 min prior to arrival felt palpitations, dizzy ate prior ... Read more
received covid 19 vaccine 12 min prior to arrival felt palpitations, dizzy ate prior to arrival no known history of allergic or adverse vaccine reactions no chest pain, SOB, tongue/lip/throat swelling, vomiting, diarrhea, abd pain remaining ROS neg Symptoms resolved after approximately 5 minutes
60 2021-01-26 chest pain, loss of consciousness 1/22/21 at 1:30p I received my 2 shot. 2 hrs later I began to experience chest pain while sitting w... Read more
1/22/21 at 1:30p I received my 2 shot. 2 hrs later I began to experience chest pain while sitting w/o accompanying SX. During the night I continued to have increased frequency and intensity of chest that waxed and waned. At 10:30 a I was awoken with intense CP and subsequently went downstairs to eat yogurt. While standing at the counter I felt myself passing out and called for assistance. I woke up 20 feet away with my husband trying to arouse me. He stated I was unconscious for 2 mins. I was to weakened to get up. He called squad and taken to ED. CXR, labs, EKG done. 2 liters NS infusion done. Discharged to home 6p with continued CP and lightheadness. F/u with PCP today as near syncopal episodes continue day 5 post-injection with CP and moderate H/A.
60 2021-01-26 chest pain Onset of sharp chest pain that worsened very quickly. Patient also experienced SOB and dizziness. ... Read more
Onset of sharp chest pain that worsened very quickly. Patient also experienced SOB and dizziness. HR 96, regular on initial check, 5 minutes later, 80, regular. Skin cool to touch. Placed patient in wheelchair and transported to the ER in the facility. Placed on monitor immediately, EKG completed, Chest x-ray, nitro, and baby aspirin administered. Zofran for nausea.
60 2021-01-26 fibrin d dimer increased, chest pain 1 week after first Moderna covid 19 dose she had sudden onset of shortness of breath and subsequentl... Read more
1 week after first Moderna covid 19 dose she had sudden onset of shortness of breath and subsequently some chest pain, She was seen in ER, had elevated D dimer. She had negative CTA for pulmonary embolism and negative cardiac workup that included ekg and cardiac enzymes. She was dishcharged home and returned in 2 days with similar symptoms and no cause found . She has had recurrent chest heaviness lasting about 1 hour episodically since that time, about 3 times, and has cardiology follow up scheduled.
60 2021-01-26 heart rate increased Pt's heart rate increased exponentially post vaccine (169). EKG was done at office and patient was s... Read more
Pt's heart rate increased exponentially post vaccine (169). EKG was done at office and patient was sent ER through ambulance. Pt has hx of panic attacks with similar sx. Pt was monitored for 15 minutes, heart rate dropped to 125. SEnt to ER for fruther evaluation. Intensity Min-0.
60 2021-01-26 heart rate increased Pt's heart rate increased exponentially post vaccine (169). EKG was done at office and patient was s... Read more
Pt's heart rate increased exponentially post vaccine (169). EKG was done at office and patient was sent to ER through ambulance. Pt has hx of panic attacks with similar sx. Pt was monitored for 5 minutes, heart rate dropped to 125. Sent to ER for further evaluation. Intensity: Min - 0.
60 2021-01-27 chest discomfort Buzzing or fizzing feeling, primarily in left chest, under skin, above my heart. Also I have arm sor... Read more
Buzzing or fizzing feeling, primarily in left chest, under skin, above my heart. Also I have arm soreness in my left arm where I got the injection, malaise/fatigue, joint pain, and mild nausea. But I'm making this report due to the strange development of buzzing/fizzing in my chest. It seems unrelated to breathing. I have a Kardia 6-lead EKG and it is reading normal. My blood pressure is about where it usually is (143/93, elevated due to as-yet untreated Cushing's Syndrome. I do take metoprolol succinate to bring it down somewhat, but diastolic has been chronically 90 and above for several months despite medication.) I don't feel this is a cardiac event, but of course I would like to be sure. It has been constant on and off fizzing/buzzing since 7:30 this morning (may also have been occurring while I was asleep), and it's now 11:08 a.m. My question is whether I need to go to urgent care/ER. Plan is to call Moderna and talk to them about this, and then make a decision about what to do next. I'm reading online that this could be an immune response, that some people with COVID get the fizzing and buzzing. But I never stop with Dr. Google. I'm going to speak with the manufacturer and then either my primary care doc or an urgent care/ER doc. So I clicked "none of the above" below, but I will likely be seeing a doctor today.
60 2021-01-28 hypertension While patient was waiting her 15 minutes after receiving the Moderna vaccine (1/21/2021), she compla... Read more
While patient was waiting her 15 minutes after receiving the Moderna vaccine (1/21/2021), she complained of a bad pain in the left side of her neck & that it was hard for her to breathe. She was assisted by EMS (who was on site). Her blood pressure was 249/149 per the patient. She also experienced some lightheadedness. It was strongly suggested by EMS & nursing staff that she be transported to the ER but she refused stating she had to work the next day. She continued to be monitored by EMS until her blood pressure stabilized & she felt better. She continued to refuse ER. She was driven home by her companion. On 1/28/2021 she sent an email to the health department showing a picture of her left arm showing redness from the injection site down to above the bend in her left arm. She reported that on 1/26/2021 her physician recommended that she not receive the second dose of Moderna. She continues to complain of high blood pressure. It is unkown if she takes medication for high blood pressure.
60 2021-01-29 chest pain Chest Pain approximately 3-4 hours post vaccine #2
60 2021-01-29 blood vessels inflammation Onset of Petechial/purpural rash along BLE starting in thighs B/L with spread to abdomen and BUE. Pr... Read more
Onset of Petechial/purpural rash along BLE starting in thighs B/L with spread to abdomen and BUE. Probable Type III Hypersensitivity vs vasculitis. Came to hospital 01/28/2021. Treated with PO steroids 60 mg PO prednisone with rapid improvement. Testing still pending.
60 2021-01-31 atrial fibrillation chills, shortness of breath, new onset a-fib, overall ache, extreme fatigue Still in a-fib w/ short... Read more
chills, shortness of breath, new onset a-fib, overall ache, extreme fatigue Still in a-fib w/ shortness of breath
60 2021-01-31 blood pressure increased Arms and hands cold and tingly, felt heavy; had a sudden onset severe headache. BP elevated; 182/104... Read more
Arms and hands cold and tingly, felt heavy; had a sudden onset severe headache. BP elevated; 182/104. symptoms resolved after 20 minutes; Within 10 minutes of getting vaccine.
60 2021-02-02 heart rate increased Tingling in tongue, feet, fingers approx 5-10 immediately after injection. The day after injection.... Read more
Tingling in tongue, feet, fingers approx 5-10 immediately after injection. The day after injection. Feelings of Adrenaline rush, increase heart rate. Waking many times at night with same episodes. PCP Prescribed Predisone and Benadryl . some symptoms still remain 3 weeks out.
60 2021-02-02 palpitations Palpitations
60 2021-02-03 blood pressure increased Right after the 2ND vaccine was administered I felt a warm feeling all over my body which resolved ... Read more
Right after the 2ND vaccine was administered I felt a warm feeling all over my body which resolved in a few minutes . Then that night my arm was very sore and warm where the injection was given. It was difficult to lift my arm. Also severe body aches and fatigue. Then I started to have a severe headache, head pressure and ringing in my ears . Took my blood pressure and it was 145/98, 155/101 and 160/100. I am monitoring it daily and it has not been below 147/92 and as high as 163/97. I have never had a problem with my blood pressure before.
60 2021-02-03 heart rate increased, hypertension Hypertensive with BP=203/98; Paulse =120; Temperature =101.3. Patient given comfort measure, 911 cal... Read more
Hypertensive with BP=203/98; Paulse =120; Temperature =101.3. Patient given comfort measure, 911 called, and transported to ER for higher level of care.
60 2021-02-03 loss of consciousness Chills (extreme) vertigo, nausea - started at 1030pm. Passed out- when I came to began vomitting - b... Read more
Chills (extreme) vertigo, nausea - started at 1030pm. Passed out- when I came to began vomitting - bile lasted approximately 4 hours. 1030 pm - began intense shaking - cold - I went to get Tylenol but found myself extremely dizzy and nauseous. I took 4mg Zofran and 1000mg Tylenol & tried to make it back to bed. I passed out - my husband witnessed and said my legs simply collapsed, He was yelling my name and he said I moaned. He is 1 wk post op TKR so he was going to call 911. I came to and began vomiting thick yellow bile. By 2:30 I felt somewhat better. Today I am achq - my back & head hurt but I am still nauseous. Fever 99.0
60 2021-02-04 chest discomfort I had a sore arm on Sunday night - and Monday it was really sore and couldn't use my arm at all so I... Read more
I had a sore arm on Sunday night - and Monday it was really sore and couldn't use my arm at all so I called in sick. Got sick on Tuesday, the January 5th - woke up with a sore throat; hoarse throat; fever; chills; cough - and chest was congested. Fever came and went. A bit of muscle aches in my chest from coughing so much. I called the DR and they sent me down to the COVID area of my doctor's office. They did COVID test and told me to go home. On Thursday, they reported that I was negative on my test. I called my Dr and she told me she had to still be quarantined for 10-14 days. She told me to take my asthma medicine and she told me to take cough medicine (OTC) and take Tylenol if I still need something else. She told me to drink fluids and rest. I went back to work on January 19th, Tuesday. I still have a little bit of congestion and cough. I had the second dose of the Moderna on January 28th. I had a sore arm but not as bad as last time.
60 2021-02-04 heart rate increased Body aches sore arm at 11:30 temp 99.5, took 2-200mg Ibuprofen, at 1 pm temp 100.7, 4 pm had chills... Read more
Body aches sore arm at 11:30 temp 99.5, took 2-200mg Ibuprofen, at 1 pm temp 100.7, 4 pm had chills and achy joints and skin burning. Also slight difficulty with swallowing mucus buildup. Temp 100.9, talk to acetaminophen 325 mg each. My body was freezing, Migraine headache, body aches and skin burning continued at 9:05 pm my watch told me my heart rate was over 120 at rest for a period of time That had never occurred to me before. I took two ibuprofen at this time. By11:30 PM temp was 101.7 all the previous symptoms returned except for the elevated heart rate. I took two acetaminophen. At 3:24 am I woke with the symptoms again temp 101.9 I took two ibuprofen. 6:30 AM I woke to a temp of 101.3 Bodyaches headache chills and took two acetaminophen. I have continued throughout the day with terms of 100.5 to 100.9 migraine headache sore arm and bodyaches.
60 2021-02-04 hypertension Roughly 10 minuets after injection, case began to feel hot, sweaty, and slightly dizzy. Case was gi... Read more
Roughly 10 minuets after injection, case began to feel hot, sweaty, and slightly dizzy. Case was given cold water, taken sweater off, and was coached through slowing her breathing down. Case began to feel better. Case was found to have high blood pressure at the time 150/104.
60 2021-02-06 heart rate increased DURING THE NIGHT AFTER VACCINE I DEVELOPED MODERATE LB PAIN, HEADACHE, NAUSEA, HAD 3 BOWEL MOVEMENTS... Read more
DURING THE NIGHT AFTER VACCINE I DEVELOPED MODERATE LB PAIN, HEADACHE, NAUSEA, HAD 3 BOWEL MOVEMENTS REASONABLY WELL FORMED AND I FELT VERY WEAK AND UNWELL. ACCORDING TO MY FITBIT I HAD AN ELEVATED HEART ALL NIGHT. MY USUAL RESTING HEART RATE IS ABOUT 52 I USUALLY SPEND THE NIGHT BELOW THAT 70% OF THE TIME. THE 1ST HALF OF NIGHT IT WAS 55-62 AROUND 3:00AM WENT UP TO 62-68 WHICH IS VERY UNUSUAL FOR ME AT NIGHT. I SLEPT OVER 9 HOURS AND AWOKE TIRED & NAUSEOUS. I TOOK AN ASPIRIN AND WENT BACK TO BED.
60 2021-02-07 hypertension, heart rate increased, chest discomfort Became weak, chilled and after 12 hours. After 24 hours - symptoms increased and felt fatigued, wea... Read more
Became weak, chilled and after 12 hours. After 24 hours - symptoms increased and felt fatigued, weak and with body aches. Could not function during the day hardly at all. After 36 hours felt almost no symptoms. Shot given on Tuesday and Thursday night awoke with very high heart rate. 114 BPM - upon arriving at work was given a blood pressure reading of 170/160. I called my doctor and due to not having any other symptoms of stroke prescribed a low dose high blood pressure medication. I took only 2 doses but due to very adverse effects to the medication stopped after 2 doses. My BP was going down as I was checking it. The medication made me feel very dizzy with fatigue and increased heart rate. On Monday morning at 1:00 A.M. - 2/8 I awoke AGAIN with chest discomfort and extremely high BPM - 140. I called 911 and was admitted to the ER. After 3 hours both BP and BPM decreased to a normal range and i was released. Chest x-ray and blood draw were all normal. Continued to experience some dizziness during the day but could function.
60 2021-02-07 fainting Fever 102.4, feeling of nausea, vomiting, diarrhea, dizzy, joint pain in back mostly, syncope.
60 2021-02-09 platelet count decreased Five days following the first dose of the Moderna COVID-19 vaccine, the patient developed diffuse bo... Read more
Five days following the first dose of the Moderna COVID-19 vaccine, the patient developed diffuse body pain, beginning in the right shoulder (for which she received a steroid injection), but then spreading to the entire body. This pain became so severe that she presented to the hospital via EMS, and was found to have a platelet count of 41 (9 days following the vaccine). No baseline platelet count is available prior to the vaccine (most recent was from 2019). Immune-mediated thrombocytopenia is being considered, and the patient has been placed on IVIG and steroids. It is now 4 days into the patient's admission, and platelets continue to fall (currently 26). Hemoglobin appears normal at the time and there is no sign of active bleeding. Of note, the patient also has positive blood cultures, so thrombocytopenia as a result of sepsis is also a possibility.
60 2021-02-11 body temperature decreased Low grade temperature, shaking chills, muscle aches, headache, fatigue, nausea
60 2021-02-12 blood pressure increased Headache started, thought is was cold front drove thru. HIGH BP. 166/105 P 60 @ 4:38 PM. Went high... Read more
Headache started, thought is was cold front drove thru. HIGH BP. 166/105 P 60 @ 4:38 PM. Went higher to 195/98 P 66 over next several hours. Thursday, still high 185/99 p 69 @ 9:58 am. Went to ER because headache was getting worse. ER doctor prescribed Norvasc 2.5 ....Next day Friday, BP still high, even with BP meds went back to ER, took CT Scan of Head, EKG and blood work. all came out normal. told to be continue with BP Norvasc and follow up with GP doctor. Saturday (today) BP still high 174/90 p 68.
60 2021-02-14 chest discomfort First dose vaccine on 2/5/2021 developed a cough that never resolved. Second dose woke up at 11:00 p... Read more
First dose vaccine on 2/5/2021 developed a cough that never resolved. Second dose woke up at 11:00 pm with fever chills, blinding headache, nausea, sever coughing, SOB and chest tightness. Called caregiver hotline the next day and they sent me to the Care where it was found my BP to be 225/120 and pulse 100. They sent me to the emergency department at Hospital where I was treated for hypertensive urgency and immunization reaction. Still suffering from elevated BP and pulse beyond what was normal prior to vaccine. Still experiencing fatigue and weakness that was not present prior to vaccine.
60 2021-02-16 chest pain I woke up around 2:30 with chills and I took my temp and no fever. I woke in morning - my hip and my... Read more
I woke up around 2:30 with chills and I took my temp and no fever. I woke in morning - my hip and my back (entire thoracic lumbar spine) was killing me. I was down! It was about 4:30 am. I got up and went into bathtub. I was very tired.The highest fever was 101. I took a hot bath and bed off and on all day. Sunday and into morning 36-48 hours later - bathtub to bed. Family helped me hydrate -soup broth/fluids. Stomach was constant pain. Hot bath helped it feel better. Stool pattern - colitis was happening - pencil diameter stools and passing gas. I haven't had colitis since I was 25. I called my provider - Tuesday after I got the vaccine; - he helped me with getting on anti-inflammatories. I started taking ibuprofen and it didn't help. I took more next time so it would help me. My lung were normal. On Wednesday - large bouts of cramping and diarrhea. Thursday and Friday my stomach pain and bowels were better but not completely gone. Thursday, I took off from work. Fever 100.2 (on Thursday or Friday). In bed on Friday for exhaustion. My Primary Care Doctor - told me to take Turmeric 2 capsules once a day- I started on Tuesday or Wednesday and Vit D3. I took Ibuprofen into following Monday or Tuesday - around 11 days after shot. In the 3rd week, I told me Allergy doctor (The second Tuesday after the vaccine) about my reaction and symptoms. I have a history of being sensitive to many meds, for ex: Robitussin etc - even if a baby dose. I took Ibuprofen 24 hrs second dose of vaccine. I stopped Turmeric 36 hours before vaccine. Abpit 5-7 days before 2nd dose I was back to normal. Date of 2nd dose - January 25th.
60 2021-02-16 chest pain Chest pain lasted 50 minutes. Patient went to local hospital emergency department and was evaluated ... Read more
Chest pain lasted 50 minutes. Patient went to local hospital emergency department and was evaluated with history, physical exam, EKG and blood tests. All were normal. Pain resolved without treatment.
60 2021-02-17 fainting This 60 y.o. female with past medical history of CLL in clinical remission and depression was admitt... Read more
This 60 y.o. female with past medical history of CLL in clinical remission and depression was admitted to the hospital yesterday for observation after she had a syncopal episode during the night after her 2nd Moderna vaccination. Patient reported that she got her vaccine on 2/12 at 8am and by that night she was experiencing chills and nausea. She then went to get up in the middle of the night as she felt she needed to vomit and became lightheaded with syncope.
60 2021-02-18 blood glucose increased Lethargic, Tiredness, muscle aches all over, Blood sugar numbers increased significantly
60 2021-02-18 loss of consciousness, fainting day 1- shivering and cold, muscle aches day 2 loss of appetite, malaise, syncope episode with loss o... Read more
day 1- shivering and cold, muscle aches day 2 loss of appetite, malaise, syncope episode with loss of consciousness
60 2021-02-19 blood pressure increased, heart rate increased A few minutes after vaccine administered, shortness of breath and weakness started. Because of my AL... Read more
A few minutes after vaccine administered, shortness of breath and weakness started. Because of my ALS, I have spasms at night. I also had involuntary contractions (spasms) in arms (forearms moved repeatedly and violently). These never happen during the day like this but can at night. Between contractions and early in the event,DR took vitals. Blood pressure 160/96 (usually 100/60) and heart rate 102 (usually 60?s). I felt odd before the contractions started that I attribute to the elevated blood pressure and heart rate. Entire episode lasted 30 minutes (estimate).
60 2021-02-20 loss of consciousness Patient states the day after vaccine received she has a headache and fever of 101.9 and hot flashes,... Read more
Patient states the day after vaccine received she has a headache and fever of 101.9 and hot flashes, She states she was attempting to go to bed and she felt hot, dizzy and passed out and fell and hit head. She states she was checked by her PCP the following Monday with no further symptoms.
60 2021-02-21 blood pressure increased Communication Comment: "Patient present in clinic for COVID-19 vaccine. Patient reported feeling som... Read more
Communication Comment: "Patient present in clinic for COVID-19 vaccine. Patient reported feeling something" going up and down her neck" about 15 mins after vaccines was administered. Blood pressure reading was obtained, elevated at 188/100, HR 100. She reported new symptoms of dry throat causing tightness sensation and numbness in tongue. Patient was given Benadryl 25mg PO and water and observed for an additional 40minutes. Her symptoms resolved including throat dryness, tongue tingling, throat tightness. Denies dizziness, rash, difficulty swallowing, hoarseness, chest pain. Vital signs improved. She reports she has blood pressure medicine at home that she was advised to take only when needed. She did not take medication today. She does not know the name of medication. Declined prescription of blood pressure medication today, agreed to take medicine she has at home and return to clinic for appointment Friday, 2/12/2021. Patient given strict ER precautions if her symptoms continue, worsen or if she develops new symptoms."
60 2021-02-21 chest pain Headache, chills, joint pain, severe fatigue, insomnia, some minor chest pain.
60 2021-02-21 loss of consciousness Patient became unconscious and fell down on 2/18 after feeling extreme exhaustion and dizziness, col... Read more
Patient became unconscious and fell down on 2/18 after feeling extreme exhaustion and dizziness, cold sweat, nausea, head confusion, swollen arm on 2/17.
60 2021-02-22 heart rate increased I received my second Moderna vaccine on 2/05/2021. Within 10 minutes of receiving the vaccine I got ... Read more
I received my second Moderna vaccine on 2/05/2021. Within 10 minutes of receiving the vaccine I got a real bad headache, was very dizzy and felt very hot all inside my body. I reported it to the nurse and she told me it was a normal reaction to the vaccine and to wait a little longer than the 15 minutes to see if it would go away. She gave me water and I did fell better and we left medical center. At around 5:30 pm that same day I started to get cold chills and body aches especially on my right side. my lower back and my right hip were hurting a lot and I was having trouble walking.at around 8:00 pm my husband notice my right foot was very swollen and I notice by breast, my arm and hand, my underarm and leg were extremely swollen and painful. I did take a Tylenol because that is what they told me to take. I was freezing cold by the time I went to bed during the night I was sweating a lot. As of that day my symptoms were: Swelling on my right side Body aches, Headaches Fever Difficulty breathing/Shortness of Breath Rapid heart rate ranging from 100-125 w/o doing anything My neck and throat were very swollen around my thyroid area Blurring vision Chills and hot flashes Fatigue/Malaise Big round red welt around my injection site about 4 inches wide and hot to the touch I finally called medical center on 2/18/21 because I still had right leg, hip pain and swelling. I had a tele-med appointment with one of their doctors and she told me I had to first get a Covid-19 test to see if I didn't have Covid. Which the test did come out negative. She also told me that maybe the vaccine triggered something in my body that was causing all the swelling. I do have an appointment for chest, hip spine x-ray and lab work for 3/22/21. I still have the hip pain but not as bad. The person who gave me my Covid test results said I should report my symptoms.
60 2021-02-22 heart rate increased All over dermititis rash. Swelling in joints. accelerated heart rate. Dizzy. Weak.
60 2021-02-23 heart rate increased same day: arm pain next day: arm pain, total body pain, exhaustion, headache, extreme CHILLS, high r... Read more
same day: arm pain next day: arm pain, total body pain, exhaustion, headache, extreme CHILLS, high resting heart rate (90+ BPM), low O2 (below 90), overall shakiness
60 2021-02-24 ischaemic stroke 10 daya after receiving Moderna vaccine: 60 year old right handed woman with migraine + chronic hea... Read more
10 daya after receiving Moderna vaccine: 60 year old right handed woman with migraine + chronic headaches, nephrolithiasis, who presented to the hospital with expressive aphasia and right facial weakness and was found to have at least to distal left MCA occlusions for which she received IV tPA. MRI brain shows a small left frontal cortical acute ischemic stroke. Post tPA ICU course has been notable for angioedema of the tongue now improved. TTE showed PFO. LDL 111, new diagnosis HLD.
60 2021-02-24 loss of consciousness Got out of bed day after - 30 min later got super nauseated - passed out face down on ceramic tile i... Read more
Got out of bed day after - 30 min later got super nauseated - passed out face down on ceramic tile in bathroom- broke nose - bruised both knees - busted forehead open- chills started about 1 hour later and lasted for several hours- temp of 100.4-
60 2021-02-25 palpitations Approx 30 minutes after my 1st Moderna vaccination, I noticed that I was having difficulty swallowi... Read more
Approx 30 minutes after my 1st Moderna vaccination, I noticed that I was having difficulty swallowing water. I soon began to not feel very well. Sort of light headed. My heart was racing. When I looked at my watch it recorded my heart rate at 160 beats per minute!! I started taking deep breaths and a technique called EFT tapping to calm me down. Eventually it worked, but I felt extreme tiredness after that. When I woke up in the morning my entire face was swollen. I also noticed on the 2nd day after vaccine shot I had dark purple circles under my eyes. None of those things have ever happened to me before in my life.
60 2021-02-28 blood glucose increased The patient reported that her blood glucose level began to rise shortly following receiving the vacc... Read more
The patient reported that her blood glucose level began to rise shortly following receiving the vaccine. The patient continued to monitor her blood glucose level and administer the correct amount of insulin following the insulin titration outline. The patient avoided eating large meals throughout the day. The patient reported that her insulin levels began to decrease approximately 10-12 hours following the vaccine administration. The patient reported that she never felt the effects or symptoms of the elevated blood glucose. The patient noticed the spike in her blood glucose due to the routine monitoring of her blood glucose.
60 2021-02-28 chest discomfort, blood pressure increased 1030am, 10 minutes after vaccine; Patient states "feeling hot", feeling a 'rush" through chest, lips... Read more
1030am, 10 minutes after vaccine; Patient states "feeling hot", feeling a 'rush" through chest, lips felt tingling sensation, and had burping. Also felt like she needed some air. 10:45am vital signs taken. Temp-97.7, BP- 138/90 ( elevated, states normal for her and has not taken blood pressure medication today) , Pulse- 72. Patient observed in my office for another 15 minutes. 10:55 Patient states feeling better and symptoms have subsided. 11:00 am Pt states ready to go home. States will self- monitor for post- immunization symptoms. ER precautions given and confirmed verbal understanding. Released home.
60 2021-02-28 hypertension Patient complained of vertigo post vaccine and was hypertensive
60 2021-02-28 fainting, loss of consciousness, blood pressure increased About an hour after receiving the vaccine my arm was very sore, it felt like someone punched me in m... Read more
About an hour after receiving the vaccine my arm was very sore, it felt like someone punched me in my arm. That night I couldn't lift my arm. I took Tylenol and put on ice on it. The next morning, I was going to the bathroom and I almost passed out. I was able to catch myself before I passed out. I felt nauseous and dizzy, I felt like I was going to throw up but I couldn't. I had chills. I went downstairs to try and drink some orange juice, I seat here and was gasping to catch my breathe. I kept thinking it was just my anxiety and kept trying to catch my breathe. I kept drinking the orange juice and the dizziness seemed to go away. I went to work, I was tired, chills and this lasted for 2 days. on Friday the 12th the rash (the rash which I developed from the 1st dose) seemed to get worse, when I took a shower, the heat from the water seemed to make the rash redder. I continued Hydrocortisone cream and then switched to Lubiderm. Neither seemed to help much so I kept switching between the two, eventually the rash did get lighter, it went away under my breast area but it is still there on my stomach. I filed a VAERS report for the first dose as well. About 8 days after receiving the vaccine, I have a tattoo on my right thigh and a red bump appeared on my tattoo, it was hurt. It was a bump and the next day the bump burst, it was hard and crusty. Then a rash developed around the tattoo. I have also had on and off fluttering of my eyelid since receiving the vaccine. I had made a dermatology appointment but I canceled it because it seems like the rash is going away and my deductible is to high. 2/26/2021 My right arm from the shoulder from down to fingers, is numb and hurting. Yesterday 02/28/2021, I got up in the morning and felt like I was going to pass out, I came downstairs and I got some orange juice. I got dizzy and couldn't catch my breathe, I told my husband to call 911,because I thought I was having a stroke. My husband said I passed out, my eye and my mouth were open, he shook my shoulders and called my name no response this lasted for about 3-5 seconds, then I take a deep gasp and came back. I was sweating profusely and pale. EMS arrived, transported me to hospital. My blood pressure was high while I was sitting and it was low when I tried to stand. I went to hospital 02/28/2021. The ER diagnosed with my syncope and wanted me to follow with a cardiologist. They believe since it was 2 weeks out since the vaccine, they do not believe it was the vaccine.
60 2021-03-01 cerebrovascular accident Acute CVA with Multiple small Infarcts to left Pariaetal and occipitral area Admitted to Medical Ce... Read more
Acute CVA with Multiple small Infarcts to left Pariaetal and occipitral area Admitted to Medical Center Admit 02/19/2021, DC 02/22/2021
60 2021-03-02 blood pressure increased Nausea, muscle weakness, dizzy, hives, throat swelling, heightened blood pressure. Started within 5... Read more
Nausea, muscle weakness, dizzy, hives, throat swelling, heightened blood pressure. Started within 5 minutes of vaccine. Lasted about an hour
60 2021-03-04 blood pressure increased Patient complained of the back of her tongue felt swollen and that it felt like "there is a cherry p... Read more
Patient complained of the back of her tongue felt swollen and that it felt like "there is a cherry pit stuck in my throat". Patients BP was elevated. No excessive saliva, No issues with breathing.
60 2021-03-04 chest pain I noticed many days after getting the first shot a kind of sick all over feeling, loose stools and c... Read more
I noticed many days after getting the first shot a kind of sick all over feeling, loose stools and cramping lower GI, nausea gassiness, a lot of phlegm in throat, headache, and some chest pain, each evening just after dark and into bedtime. The last day I had it was yesterday and it was all day. My doctor asked me to report this to you. By the way I have the date wrong my vaccine was 02/19/2021 but the form won't let me go back to fix it. Symptoms came up suddenly 7 days later.
60 2021-03-05 hypertension, chest discomfort About 3 hours getting the shot, I started having tightness in the chest along with a stabbing pain i... Read more
About 3 hours getting the shot, I started having tightness in the chest along with a stabbing pain in my left shoulder blade. It was severe at times then it would subside a little. I chewed on a aspirin to make the tightness go away and it seemed to help but then the pain would return. This continued for around 48 hours then subsided. I was seriously considering going to the ER, but I didn't want to risk exposure to Covid by going to the ER. I do have high blood pressure but I have NEVER felt anything like this. I thought I was having a heart attack. Other side effects were ones I read about but usually after the 2nd shot. This was my FIRST shot. I had a temperature of 100.6 although I was FREEZING. My feet were cold to the touch and yet the thermometer read over 100. Pain at the injection site ( it hurt like hell when the bedsheet touched my arm! Alternated between burning up and freezing.
60 2021-03-06 heart rate increased Modern a COVID-19 Vaccine EUA. First 24 hours- mild soreness not at injection site but 2-3 inches... Read more
Modern a COVID-19 Vaccine EUA. First 24 hours- mild soreness not at injection site but 2-3 inches below injection site. Days 2, 3, 4 muscle fatigue and sensation of unusually elevated heart rate during stenuous exercise significant enough for me to take ?breathing breaks? to allow my heart to slow - like enforced interval training. Days 5, 6, 7, 8 no noticeable side effects. Day 9 slightly stiff sensation and itching at injection site, no rash, no swelling. Day 10 (today) itching at injection site significant enough for me to stretch in my sleep. Injection site visably swollen, warmer to the touch than surrounding area, no rash.
60 2021-03-08 chest discomfort At 2:50 patient reported feeling dizzy and felt like she was going to "pass out" BP taken- 111/75, H... Read more
At 2:50 patient reported feeling dizzy and felt like she was going to "pass out" BP taken- 111/75, HR- 107, POX 98%. Patient was asked by RN to remove sweater and mask. Patient reported feeling better, however feeling a little dizzy and nauseated. Patient denied swellings of tongue, chest tightness. Patient asked for water and was given water. Patient sat in the chair for a few minutes and refused to lay down, patient reported feeling better after having water and reported feeling this before. Patient reported feeling better , vitals retaken BP-114/75, HR-77, PT reported feeling much better and wanted to go home to eat as she did not eat lunch. Patient refused to stay longer and reported "I just want to go home to eat". Patient was called at home at 03:47 and asked how she was feeling. Patient reported feeling much better and was now home and about to have something to eat. Patient was advised to
60 2021-03-08 nosebleed 25 minutes after receiving shot while driving home left side of head hairline felt like electrical l... Read more
25 minutes after receiving shot while driving home left side of head hairline felt like electrical line, left eye began twitching, hard to drive, head did not feel normal-felt like heavy, heavy brain fog. 40 minutes after shot, trouble walking, had to use cane and hang onto wall/furniture, very painful walking. Brain fog lasted 24 hours. Trouble walking for 3 days. Nose bleed on 1st night after getting shot while sleeping. For first 2 nights after getting shot had tingly, like many fine needles from knees up to waist. First 2 days had hot/cold feeling, nausea...all in all incredibly unpleasant.
60 2021-03-08 hypotension Hypotension in the 70s/40s despite IV fluid replenishment. Per our MD DC/transfer note: PEG displ... Read more
Hypotension in the 70s/40s despite IV fluid replenishment. Per our MD DC/transfer note: PEG displacement, ongoing sepsis, hypoglycemia. Assess for other reason for hypotension including sepsis, cardiogenic shock, acute abdominal processes. patient was transferred to the Hospital ER where she expired
60 2021-03-09 chest pain First a cough that produced massive amount of mucus as I would have with a severe allergic reaction ... Read more
First a cough that produced massive amount of mucus as I would have with a severe allergic reaction to mold. Pain in my left arm that spread to my finger tips and upper back. Both lasted all day. Mucus and cough in to the next day (today). On second day (today) severe pain in my left chest that started in the afternoon and by 6:30 pm spread to my left back. Feels like massive muscle cramping. Head aches on day one and the first half of day two. Head aches in spurts and lasted a short while but were intense.
60 2021-03-09 heart rate increased 60 year old female experienced increasednheart rate and SOB 8 minute after receiving vaccine, Patien... Read more
60 year old female experienced increasednheart rate and SOB 8 minute after receiving vaccine, Patient is on 4 liters of 02. History of COPD & pulmonary hypertension, on list for lung transplant. EMS called
60 2021-03-09 fast heart rate Tachycardia from 100 bpm to 120 bpm for an approximately 5 hour period (2:00 pm to 7:00 pm)
60 2021-03-10 chest pain numbness and pain in arm alway down to fingertips and into chest, hot and red upper arm around and t... Read more
numbness and pain in arm alway down to fingertips and into chest, hot and red upper arm around and to elbow, fever, nausea, headache, tiredness, could not walk up stiars
60 2021-03-10 heart rate increased Chills started at 7pm the day of vaccine,. Epic Headache. Fever 99.8 and high pulse 120, the next ... Read more
Chills started at 7pm the day of vaccine,. Epic Headache. Fever 99.8 and high pulse 120, the next morning
60 2021-03-11 heart rate increased, heart rate irregular, palpitations On Friday, March 12th, 2021 approximately 10:35 am, 60-year-old female received her first dose of Mo... Read more
On Friday, March 12th, 2021 approximately 10:35 am, 60-year-old female received her first dose of Moderna Vaccine (Lot Number: 003A21A) in her left deltoid at the facility. Patient received the Moderna Vaccine. After which she sat in the designated medical observation area for her allotted 15 minutes. Approximately nine minutes post-injection around 10:44 am, she felt a bit ?wobbly? when standing up. A medical assistant called Emergency Medical Services (EMS) immediately and the Physicians Assistant went over to assess patient's symptoms. During the wait time for EMS?s arrival, the physicians assistant performed an assessment. Patient states to have experienced lightheaded-ness, mouth/tongue tingling, shortness of breath and palpitations. She denied throat constriction, denied itching, redness or pain at the site of injection. She said the tingling she did experience resolved around 20 mins post-injection. During the assessment, the physicians assistant noted clear breath sounds, irregular health rhythm, increased heart rate, extra-ocular movements intact with no nystagmus, no redness or swelling on the injection site and good grip strength. Upon EMS arrival at approximately 10:48 pm, the firefighters triaged as per their assessment. She expressed that she is taking ?Lexapro? and allergic to sulfa-drugs. She claims to be ?borderline diabetic? and that the lightheaded-ness has ?never happened before? The EMS took her to a separate room in the building and assessed her further. After approximately 20 minutes she left and did not leave in an ambulance against medical advice. She left with her husband and went home. She was made aware that she should go to the hospital immediately if she felt her health was compromised.
60 2021-03-11 heart rate increased Patient experience high heart rate. On and off for 15 minutes.
60 2021-03-11 fainting Fever, chills, sweat, near pass out, severe stomach cramping
60 2021-03-12 chest pain Dizziness, weakness, chest pains, headaches, fatigue, muscle aches
60 2021-03-13 chest discomfort Sore arm started 1 day after injection, worsened for 2 days, then dissipated after e days. Mild Re... Read more
Sore arm started 1 day after injection, worsened for 2 days, then dissipated after e days. Mild Redness, itching, and mild swelling at site started on 7th day after injection (03/11) and persists as of today (3/14). Mild fatigue, brief mild periods of chest tightness, and generally feeling unwell began on 3/10 and persisted through 3/12 PM.
60 2021-03-13 heart rate irregular As a brick it came on. Throat started to swell up, and dry, very nauseous, shaking while no fever, e... Read more
As a brick it came on. Throat started to swell up, and dry, very nauseous, shaking while no fever, eliminated all stools, and my heart staryed to beat fast mixed up with irregularity. It settled a bit after 1 hour after i did Therapy, a tapping method to support the immune system and help with adverse reactions. Stayed nauseous for days, and as of today 3/14/2021 i still don't feel like myself yet. Still tired, weak, a bit shaky, just off.
60 2021-03-14 blood glucose increased Gave a patient a Moderna vaccine today. ( 03/15/2021) Patient stated before I gave then vaccine to ... Read more
Gave a patient a Moderna vaccine today. ( 03/15/2021) Patient stated before I gave then vaccine to her that she had felt dizzy after receiving her flu vaccination previously. Patient became dizzy and lightheaded after I gave her the Moderna (10:40am). Patient was concerned that her blood sugar was low and took a glucose gel packet from her purse. She stated that she thought she might faint, so moved the patient to the floor with her feet elevated. I took the patient's blood sugar, it was 211. I monitored her pulse, it was strong and not racing. Placed a cool wet rag on the patient's forehead. Patient remained lying down for 10 minutes and said she was feeling better and asked to sit up. I assited her in sitting up on the floor. Had her sit on floor for 5 minutes more before helping her to a chair. Continued to monitor patient for an additional 10 minutes. She stated she felt better and had her companion escort her to his car and drove home. Followed up with patient an hour later, she stated that she felt much better and had eaten lunch and was taking it easy. She thanked us for assisting her. I will follow up with her tomorrow.
60 2021-03-14 haemoglobin decreased, platelet count decreased Patient had severe fatigue and poor appetite following vaccination for 1 month, upon having blood wo... Read more
Patient had severe fatigue and poor appetite following vaccination for 1 month, upon having blood work done on 3/11/2021 patient was found to have pancytopenia and was sent to the hospital. Patient had a platelet count as low as 4, and required multiple platelet transfusions along with PRBC transfusion. Patient believed to be having an immunologic response to the 2nd moderna covid vaccine.
60 2021-03-14 fast heart rate, palpitations 3:30 At home, exerienced tachycardia, palpitations, headache; Drove self to hospital ED; Had hyperte... Read more
3:30 At home, exerienced tachycardia, palpitations, headache; Drove self to hospital ED; Had hypertension, monitored for several hours. Was diagnosed with Adverse reaction to vaccine and to follow up with PCP on 3/15/2021
60 2021-03-15 chest discomfort, heart rate increased Got her vaccine with no problem, got her vaccine and felt dazed as she was going to the waiting area... Read more
Got her vaccine with no problem, got her vaccine and felt dazed as she was going to the waiting area. She was anxious and then started feeling heaviness in her chest. She felt dazed, nothing registered and was not focused on anything, and sat for 25 minutes. She then got up and walked to the car, felt like she was in the clouds and her right lung was really, really bothering her by the time she got home and tired. Her heart rate was 140 and very fast. She didn't feel as if she was anxious but just blaise. She was really winded and exhausted by the time she got home. She had not eaten before she got the vaccine, made herself a sandwich and fell asleep and slept for about 3 hours. When she woke up she had a very, very sore arm. Then on Saturday, she woke up around 3:00 AM, and could not go back to sleep as she was wide awake. Then every task that she did just exhausted her and still felt heaviness in her chest and back and the right lung was really bothering her like she had worked like an animal for a period of time. She has a small apartment and it doesn't take any energy to walk to the kitchen. Saturday she felt fine, was cleaning and felt good. Sunday she slept all day and her right lung was still hurting her. Yesterday was still exhausted and winded feeling. Today, 3/16/21 she is still feeling the same way and exhausted doing simple tasks. She has a nodule in her right lung and several spots in her left lung but nothing is being done for them. The vaccine seems to have exacerbated the symptoms and made them worse. The injection site is a little sore but nothing out of the ordinary for a vaccine. She took two Advil for her symptoms which did help as she had pain in her head with this which will last for 5-10 minutes and then goes away. She has notified her doctor and she has an appointment on Friday at 11:00 AM.
60 2021-03-15 chest discomfort 3/11 Day 1-immediate and severe headache, 3/12-13 Day 2-3 body aches, flu like symptoms, headache, ... Read more
3/11 Day 1-immediate and severe headache, 3/12-13 Day 2-3 body aches, flu like symptoms, headache, tight chest, upset stomach 3/15-16 Day 5/6-severe headache, upset stomach, tight chest AND NOW on DAY 6 the injection site is red, warm to the touch, swollen and itchy-like an allergic reaction. I have small hives/itches on other parts of my body. Generally don't feel well
60 2021-03-15 palpitations I was waiting as required and I started feeling itchy. Then it started in my legs and knees, and end... Read more
I was waiting as required and I started feeling itchy. Then it started in my legs and knees, and ended up staying in there an extra 20 min. I left and got halfway over the bridge and had to go back. My lips got numb and the tip of my tongue. I kept having to clear my throat. I went to the ER and my heart felt like it was pounding out of my chest. Once they gave me the Benadryl, Pepcid and steroids via IV, it got better but didn't go away. They also gave me oral steroids to take at home. The symptoms remained for 3 days or more. I also had a metallic taste in my mouth. I was awakened during the night multiple times. After about 3 days the itchiness and blotchiness went away, but the taste remained for like a week. After a full week, I was back to 100%.
60 2021-03-15 fast heart rate, chest discomfort I was feeling very flush and couldn't get cooled down when all of a sudden I got very light headed, ... Read more
I was feeling very flush and couldn't get cooled down when all of a sudden I got very light headed, couldn't breath very good. Then the pounding in my chest started with pressure in my neck and head. After an hour I ended up in the ER with SVT. My heart was beating close to 200 beats a minute. My heart slowed down on its own to 114 beats a minute.
60 2021-03-15 fainting, pallor At approximate 1435- this RN at patient?s side. Speaking with patient, patient c/o feeling hot. Pa... Read more
At approximate 1435- this RN at patient?s side. Speaking with patient, patient c/o feeling hot. Patient verbalizing, state not feeling well. RN called to bedside for assistance. Pulse ox 96% HR 46. Patient attempting to drink some water, states not feeling well. Patient noted to be slightly pale. ? Adm team notified- RN (Lead RN in post recovery) and site lead ? Adm team at bed- and RN ? Patient became pale, states feeling funny, assisting to lie down, syncope episode for approximately 10 seconds noted ? Patient laid down on floor with assistance by RN and RN ? no trauma ? Legs elevated ? 1435 Hr 46, B24 BP 139/90, pulse ox 96% ? 1436-Legs remain elevated, patient verbalizing giving history ? 1437- patient denies allergies, states has never received any type of vaccine before ? 1438- patients states prior history of MI in Dec/2019. On medications- Benazepril, Asa, Lipitor ? Patient denies pain, states feeling better, refusing 911 ? 1443 BP 160/100, P63, R-20 Pulse ox 94%. Patient states feeling better refusing 911. Skin color improving, remains verbalizing ? 1450- patient refusing 911, requesting husband ? 1451- skin color improved, perfused, assistance to chair, calling husband ? 1453- husband at bedside ? 1454 patient remains awake, alert, oriented x4. Skin color perfused, warm and dry to touch. Husband remains at bedside, patient states ?feels fine? states at baseline. ? 1458 vital signs updated- BP 130/90, Hr 61, R 16 pulse ox 96 percent. Patient laughing, states feel fine, RN remains at bedside, speaking and educating patient. ? 1459 Patient signing for refusal of transport. Patient educated by this RN and RN any changes in status to call 911. Patient and husband stated understanding. ? Patient signed for refusal of further observation and refusal of transport. Patient ambulatory on leaving with strong, steady gait.
60 2021-03-16 chest discomfort, palpitations 1. 2/20 sharp rib pain. Predominantly right hand side 2. 2/23 Covid 19 shot /Headache/ Tightness in... Read more
1. 2/20 sharp rib pain. Predominantly right hand side 2. 2/23 Covid 19 shot /Headache/ Tightness in lungs afterwards 3. 2/24/21 shortness of breath, struggled with getting sentences out, rib pain, raspy voice 4. 2/25 called pulmonary. Said if not better by tomorrow call. 5. 2/26 Pain in ribs worse, struggled with breathing, short of breath. Prednisone prescribed & X-ray 6. Lungs eased, rib pain remained, sweaty, pounding in heart 7. 3/3 called pulmonary. Very winded, fatigue & rib pain. Dr. thought pleurisy & upped prednisone & antibiotic 8. 3/10 Sought out Pulmonary again. Short of breath, rib pain tolerable w/800 mg Tylenol. Extreme fatigue. Cat scan & blood work ordered 9. 3/11 note Cymbalta not renewed (cold turkey w/d) until ordered 3/12. Arrival expected Monday. 10. Fast forward lungs better, winded easily. Rib pain intermittently, extreme fatigue Fatigue - No reprieve, when move, get easily dizzy, feel like going to faint, feels like I?m tanking. Light headed goes away, fatigue seems to be getting worse. Dr. upped Losartin due to BP has changed since this event. No one is saying this is related. I go to a heart specialist next.
60 2021-03-16 chest pain Within two hours I felt heat in the left arm and head twice, then four hours later I had pinching in... Read more
Within two hours I felt heat in the left arm and head twice, then four hours later I had pinching in the left side abdomen colon area, Eight hours later I felt pinching in the chest area and repeated pinching in the colon area. Later towards evening I felt a slight headache and then stiffness in the left neck area. Fifteen hours later I felt intense pain in the right hip and towards the buttock region, including right leg pain for about six hours. It was very difficult to walk when the pain came on.I got the sniffles on and off that day. I experienced leg stiffness in both legs for over two weeks and it was painful to walk during this time. It was like an artherosclerotic event in that everything stiffened up and my legs felt like logs. I started to get on and off pain in the upper inner thigh region, which felt like nerve pain. This nerve pain was often felt in both legs as well. My daily walk became very difficult to do. The second week I began to have a vein pulsate in my right forearm and a tic developed in that area. This went on for three days. By the third week I started experiencing daily headaches. My blood pressure increased in the third week to about 167/90 up from 136/80. Up until today, March 17 I still have mild headaches on and off, and some mild inner thigh nerve pain, and minimal stiffness and mild pain in both of my legs. I am very concerned about receiving the second dose and have contacted two of my physicians.
60 2021-03-16 heart rate increased I immediately had an increase in heart rate to 110 bpm. after getting the injection. I sat for 30 ... Read more
I immediately had an increase in heart rate to 110 bpm. after getting the injection. I sat for 30 minutes instead of the 15. My heart rate still continued to stay high. I drove home and continued to monitor my heart rate. My heart rate stayed elevated for the remainder of the evening. The lowest was around 99 bpm when I retired to bed. Woke the next morning with a heart rate in the 80's. Normally my resting heart rate is around 62 bpm. Within 24 hours, my heart rate was back to normal. As of today, my heart rate is back to normal. I have a slight cough, but I believe that is due to my sinus allergies.
60 2021-03-17 heart failure On 2/1/2021 they performed CBC, the result was aseptic bacteria so it came out and she was taken to ... Read more
On 2/1/2021 they performed CBC, the result was aseptic bacteria so it came out and she was taken to the hospital. They removed the tube in the hospital, (she remained in the hospital) First she was hospitalized and then she was transferred to the Medical Center Hospital to auscultate bleeding in the stool and to be evaluated by the Gastroenterologist. This specialist performs the necessary studies, they do not give a diagnosis and in the process she dies. The hospital indicated that she had a blood drain and heart failure.
60 2021-03-17 nosebleed Nosebleed occurred 2 hours after vaccinated (2 dose). lasting 530-630 in varying degree. Spotting un... Read more
Nosebleed occurred 2 hours after vaccinated (2 dose). lasting 530-630 in varying degree. Spotting until 5-6AM 3/18/2021. Reports arm (left) sore and slight body aches. Will f/u with MD if bleeding from nose resumes. Reports using Flonase in AM (11A)
60 2021-03-17 nosebleed Nosebleed occurred 2 hours after vaccinated (2 dose) lasting 530-630 in varying degree. Spotting un... Read more
Nosebleed occurred 2 hours after vaccinated (2 dose) lasting 530-630 in varying degree. Spotting until 5-6AM 3/18/21. Reports arm (Left) sore and slight body aches. Will f/u c MD if bleeding from nose resumes. Reports using flonase in AM (llA) due to allergies.
60 2021-03-17 fainting Initially Experienced Vasovagal syncope 6 hours after vaccination along with Hot flash and extreme w... Read more
Initially Experienced Vasovagal syncope 6 hours after vaccination along with Hot flash and extreme weakness Severe abdominal cramps followed about 3 hours later with bowel movements turning into diarrhea.
60 2021-03-17 blood clot I received my vaccine on Sunday March 7 and in the morning of March 12, I woke up to a large bruise ... Read more
I received my vaccine on Sunday March 7 and in the morning of March 12, I woke up to a large bruise with a hard clot on the inside of my right forearm measuring 7cm x 4cm with a large clot in the bruise. I also have a smaller spot which has a firm bump under the skin. I did not hit my arm or injure it during my sleep or before going to bed.
60 2021-03-20 lightheadedness, heart rate increased, blood pressure increased 10 minutes after receiving the vaccine, the client had a vaso vagal reaction in the waiting area. Sh... Read more
10 minutes after receiving the vaccine, the client had a vaso vagal reaction in the waiting area. She fell out of her chair to the floor. Staff immediately responded. She was able talk but shaking. BP and HR elevated initially. Assisted to wheelchair after monitoring. Vitals returned to normal range, client no longer shaking and speech clear.
60 2021-03-21 chest discomfort dizziness, flushing, slight chest tightness
60 2021-03-21 loss of consciousness, blood pressure decreased, lightheadedness Pt complained of feeling dizzy after 12 minutes of post observation. Pt lost consciousness for brie... Read more
Pt complained of feeling dizzy after 12 minutes of post observation. Pt lost consciousness for brief period. Blood pressure dropped from 120/73 to 98/59. Pt regained consciousness and was able to give one word answers. EMS was called. IV was started and IV fluids were administered. Upon EMS arrival, pts blood pressure was noted to by 70/50 and she again lost consciousness. Pt was transported to local ER by EMS. Pt was later diagnosed with a vasovagal response to vaccination.
60 2021-03-21 loss of consciousness Patient was observed, to tilt head back like going to pass out, then slumped forward in chair, extre... Read more
Patient was observed, to tilt head back like going to pass out, then slumped forward in chair, extremities convulsed and patient came to. She reported feeling dizziness, chills, nausea and tingling in both hands. I asked her if would like us to call EMS but refused medical attention. She knew date and location when asked. We offered to have family member pick her up but refused.
60 2021-03-22 blood pressure increased Subjective sense of throat swelling/swallowing. Vitals stable but flushed and elevated BP
60 2021-03-22 cerebral haemorrhage Patient admitted to hospital on 3/6/21 with sudden onset right-sided hemiplegia and aphasia. CT show... Read more
Patient admitted to hospital on 3/6/21 with sudden onset right-sided hemiplegia and aphasia. CT showed acute intraparenchymal brain bleed. Family chose palliative care over neruosurgical intervention due to sever neurologic impairment and inability to communicate. Patient was discharged to home hospice on 3/9/21.
60 2021-03-22 chest pain soreness at injection site that over next 8 hours radiated down left arm to elbow, up into shoulder,... Read more
soreness at injection site that over next 8 hours radiated down left arm to elbow, up into shoulder, upper chest and shoulder blade. extremely painful at about 24 hours post injection . Pain lessened somewhat after 48 hours. But moderate pain still 5 days post injection and counting
60 2021-03-23 heart rate decreased PT REPORTED DIZZINESS TO US AFTER HER IMMUNIZATION. SHE DECLINED OUR OFFER TO CALL 911 FOR HER. WE T... Read more
PT REPORTED DIZZINESS TO US AFTER HER IMMUNIZATION. SHE DECLINED OUR OFFER TO CALL 911 FOR HER. WE TOOK HER BP AND PULSE. HER BP WAS 132/88 AND HER PULSE WAS SLIGHTLY LOW AT 57. WE ADVISED PT TO SIT AS LONG AS SHE NEEDS TO AVOID FAINTING, AND TO NOTIFY US IF HER STATUS CHANGES AT ALL. WE PROVIDED HER WITH A BOTTLE OF WATER. SHE WAS WITH A CAREGIVER OR SPOUSE HERE AS WELL. AFTER ABOUT 5 MINUTES, WE TOOK A SECOND BP AND PULSE READING. BP WAS 142/99 AND PULSE WAS 56. SHE AND HER CAREGIVER OR HUSBAND PROCEEDED TO GO TO EMERGENCY ROOM. THEY PREFERRED TO TAKE THEMSELVES INSTEAD OF CALLING 911 FOR AN AMBULANCE.
60 2021-03-23 heart rate increased Within about 3 to 4 minutes of vaccine I experience extreme rapid heart beat that made me light head... Read more
Within about 3 to 4 minutes of vaccine I experience extreme rapid heart beat that made me light headed. I do have anxiety but I have never experienced this with my anxiety nor was I feeling anxious at the time. It last about a minute and left, I did not experience any other reactions at the time of vaccination. Wondering if this is normal or should I get my next vaccine in a more medical type setting?
60 2021-03-24 palpitations All symptoms started 2 hours after 1st dose of Moderna Shortness of Breath Difficulty swallowing (B... Read more
All symptoms started 2 hours after 1st dose of Moderna Shortness of Breath Difficulty swallowing (Benadryl 25mg Oral One Time Dose) Throat tightness Palpitations
60 2021-03-25 chest discomfort My arm was sore within 8 hours of receiving the vaccine. About 21 hours after receiving the vaccine... Read more
My arm was sore within 8 hours of receiving the vaccine. About 21 hours after receiving the vaccine I had chills, fever, headache, muscle ache, chest tightness, light-headedness, and fatigue. After my fever broke Friday morning, I continue to have a horrible headache, light-headness and fatigue.
60 2021-03-25 hypertension All over body rash, onset approximately 1.5 days after injection. Began on inside of left bicep in t... Read more
All over body rash, onset approximately 1.5 days after injection. Began on inside of left bicep in the early morning hours, but had spread to face, neck and upper torso by 10 am 2 days after injection. Went to see physician @ 3 pm same day. Blood pressure was the highest it has ever been: 192/86. Was given a steroid injection and prescribed Hydroxyzine and a steroid cream. Dr asked that I monitor BP and if it came down she would call in a prescription for prednisone. BP did come down and began taking prednisone yesterday, 3/25/21. Rash has worsened so that the individual red spots have combined to almost completely cover my body in red. I have also experienced extreme fatigue and low grade fever, 99.5 degrees.
60 2021-03-26 hypertension, chest discomfort Itchy mouth/neck. No hives. "Chest feel tight" Benedryl 25 mg given. itching decreased 11:14 B/P16... Read more
Itchy mouth/neck. No hives. "Chest feel tight" Benedryl 25 mg given. itching decreased 11:14 B/P160/92, Pulse Ox 97%, RR14 and Pulse 71 11:24 140/82, Pulse Ox 98%, RR 12 Pulse 78 11:40 B/P 130/78 , Pulse OX 99%, RR 12 Pulse 77 Per RN observer patient felt fine when she left. No symptoms.
60 2021-03-27 oxygen saturation decreased High Fever Low O2 levels Pain throughout body like I had with Severe Covid
60 2021-03-30 blood pressure increased Patient was 10 minutes post vaccine sitting in observation area. She was talking to her friend and s... Read more
Patient was 10 minutes post vaccine sitting in observation area. She was talking to her friend and suddenly asked to be taken to her office. She said that she was seeing 3 of him. The friend went to the EMS personel who were staffing the event for assistance. 10:15-BP was 176/112 R arm, 10:20-167/114. Double and triple vision continued. She was put on a stretcher by EMTs. Head was elevated 45 degrees. 10:25-153/101, HR 88, still seeing "double". Began to chill and entire body was shaking profusely. Blankets were give. 10:30 AM-154/81, SaO2-99%, P-87. Husband, a retired paramedic, who had been notified, arrived. 10:35 AM-154/95, P-91 10:40 AM-156/94, 10:45 AM-158. Paremedics and nursing staff advised for patient to go to the ER or Urgent Care but she refused. 10:50-BP was 166/138, P-91. Husband insisted that he would monitor her at home. Taken to car by stretcher to go home. 9 PM, I called patient to follow up. She said that her double vision lasted for hours but finally subsided and that she had a "wicked headache". She said she did not feel like herself.
60 2021-03-30 chest discomfort, ischemic chest pain Felt like she was having a heart attack; Had pressure from chest down to her stomach; A spontaneous ... Read more
Felt like she was having a heart attack; Had pressure from chest down to her stomach; A spontaneous report was received from a consumer concerning herself, a 60-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and she felt like she was having a heart attack / myocardial infraction and had pressure from chest down to her stomach / chest discomfort. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 17 Mar 2021, approximately six days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 23 Mar 2021, the patient felt like she was having a heart attack and had pressure from chest down to her stomach. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The event(s), felt like she was having a heart attack and had pressure from chest down to her stomach, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
60 2021-03-30 chest discomfort First noticed a sore back of the mouth, my throat itself did not hurt when swallowing, just the way ... Read more
First noticed a sore back of the mouth, my throat itself did not hurt when swallowing, just the way back of mouth. Then I noticed a rash on the trunk of my body. Below shoulder blades, above panty line. Most red spots on front of body, sporadically spaced. Not itchy. Some spots on back side. Two areas where the spots were more grouped like half inch by 1.5 inch both on left side of body under armpit and top of breast. Otherwise spaced all over like on belly area. Day of shot I was anxious and was a very little dizzy with chest flipping after shot, but could breath fine. I think I noticed the sore throat next the next evening. And maybe the rash the next day after that - not really sure of the timeline. Today is 1 week and 3 days after shot. I still have the rash. The sore throat is much better. Chest still flip flops but not very often - still could be anxiousness.
60 2021-03-30 hypertension It was a mild allergic reaction - I felt it in my cheek bones and in my lips. My cheekbones feel air... Read more
It was a mild allergic reaction - I felt it in my cheek bones and in my lips. My cheekbones feel airy and lips weren't quite tingling but felt strange. It took me a bit to put this together with vaccine and my blood pressure was really high when I went to the doctor on the 16th. It was really high - 170 over 90, I think. It usually runs in the 130s. Now they have put me on blood pressure medicine. It was so high my dentist wouldn't see me. He had me also start Zyrtec every day and put me on the blood pressure med and I'm still on both of these meds. Zyrtec and another antihistamine that I took for a couple of days helped the allergic reaction symptoms go away. I will go again to the doctor soon to see if I can get off the blood pressure medicine.
60 2021-03-30 pulmonary embolism Pulmonary Embolism, symptoms started 3/14/21, diagnosed 3/15/21
60 2021-03-31 blood pressure increased Pt called the day after receiving her vaccine, stating she was experiencing chills,body aches, naus... Read more
Pt called the day after receiving her vaccine, stating she was experiencing chills,body aches, nausea, vomiting, could not keep nausea meds or even sips of water down, also reports her blood pressure spiked and she does not take any blood pressure meds. Pt was advised to report to ER.
60 2021-03-31 blood pressure increased She got her vaccine and within 15 minutes she was having a hard time breathing. She told her husban... Read more
She got her vaccine and within 15 minutes she was having a hard time breathing. She told her husband that she needed to go to the bathroom and see if she could get the feeling to stop. She went into the bathroom and she was gasping and choking for breathe. They got her into the ambulance and her BP was extremely high 128/90 and her BP normally is 98/60. They started an IV, breathing treatments and oxygen. She was gagging up saliva and having a hard time breathing. They got her to where she was calm. Her body when it is under extreme amounts of stress goes into seizures, which it did. She then was transferred to in for observation. By the time she arrived her BP had come down and was starting to stabilize. She was given steroids, discharged home. She has had problems breathing, extreme/sharp pain on the left side of her head behind the eye, which has been going on for over a week. By the end of the day she is exhausted. She has never had a hard time breathing at high altitudes and now she can walk up the stairs and be winded. This has all happened since receiving the vaccine. She sent a message to her doctor who did seem concerned. The pharmacist at the facility at the time said that she was fine, to leave her alone. The EMT's said that there was something wrong with her and took her to the hospital. The hospital did not give her any long-term medications to take. She does have a routine APT with her PCP on 4/6/21. On Thursday she woke up and asked her husband if her face was swollen, and he asked why, she stated that her face was numb, and some spots so sensitive that she could not brush her hair. This was on the left side. The sensitivity is still there, but not as intense.
60 2021-03-31 body temperature decreased Moderns COVID-19 Vaccine EUA Aches, chills, low temperature, diarrhea, sore muscle at the injection ... Read more
Moderns COVID-19 Vaccine EUA Aches, chills, low temperature, diarrhea, sore muscle at the injection Rest, warm blanket, Aleve, and liquid and light meal
60 2021-03-31 palpitations Patient was vaccinated at 945, she took benadryl and famotidine immediately prior to vaccination. Pa... Read more
Patient was vaccinated at 945, she took benadryl and famotidine immediately prior to vaccination. Patient then began to complain of "lightheadedness" and "palpitations." She also then began to complain of trouble swallowing. We escorted her to our triage area and obtained vitals. Oxygen Saturation maintained at 99-100% and the pulse ox remained on the patient the entire time. Initial BP was 138/82, and heart rate was staying in the 80's. Per patient and her son her heart rate is normally 50-60. Her blood pressure was checked multiple times with a downward trend. Her blood pressure is normally 100-110/60 per patient and her son. Last blood pressure was 127/78, heart rate was 54 and o2 was 100%. Patient stated all symptoms had resolved. Patient left the vaccination clinic at 1050 with her son, who is living with her and will be home.
60 2021-03-31 fast heart rate Within seconds of receiving the first dose of the Moderna Covid-19 vaccine, I began to experience a ... Read more
Within seconds of receiving the first dose of the Moderna Covid-19 vaccine, I began to experience a rapid heartbeat (tachycardia) and immediate fecal urgency. I experienced a rapid heartbeat for 3-5 minutes followed by what can be described as a "hot flash." Both symptoms (rapid heartbeat/hot flash) subsided within 10 minutes of receiving the vaccine. I asked the personnel in the observation room to use the bathroom facilities, but was told the accommodation of this request was really not possible - since there were only two (2) people monitoring about 50 people in the observation room who had received vaccines. My using the restroom facilities would have required one of the medical professionals to leave the observation room to accompany me to the restroom. Once my observation period ended, I proceed to the bathroom and emptied my bowels. The entirety of these symptoms abated after I was able to use the restroom facilities.
60 2021-04-01 blood pressure increased About 5 minutes after vaccine, I had onset to headache starting in the back of my head and over my t... Read more
About 5 minutes after vaccine, I had onset to headache starting in the back of my head and over my top and it very quickly escalated - to felt like someone hit me in the back of my head. I hunched over; I was shaky and light- headed and needed help standing up and they put me in a wheelchair. I was feeling very confused and they caused me an Emergency response team at the Hospital. They did vitals and I don't remember what they were. My BP may have been a little elevated. I was nauseous; I had light sensitivity. They checked my blood sugar which was fine. They had me lay there and rest for an hour. The light headedness went away and the nausea went away and I had the headaches for the next two solid days. No treatment. I did have fevers as high as 102 almost - 101 something. Typical flu like symptoms with severe migraines. I was having all the curtains closed, couldn't look at a screen for two days - I was down with the migraine. The third day, I was better which was my day off. They kept me out of work until the 26th, I think I was back to work by the 27th.
60 2021-04-01 chest pain, blood clot She got her vaccine and had no reactions at all. On 3/12/21 she was in her car and started having s... Read more
She got her vaccine and had no reactions at all. On 3/12/21 she was in her car and started having stabbing pain in the left side of her chest under the rib. She thought it was gas pains and dismissed it, and then it started radiating towards the front and the stomach. On 3/16/21 she went to the ER and they did a CT scan that showed that she had a blood clot on her spleen. With that they gave her the diagnosis of idiopathic splenic infarction. She was then sent by ambulance to another hospital to be admitted in case she was needing surgery. She was given heparin and on that for 2 1/2 days. They determined that 60% of her spleen is dead, blood supply cut off to it, and the other 40% is nonfunctional. On 3/19/21 they gave her vaccines of Prevnar 13, HIB, meningococcal, meningococcal B, and a flu vaccine. She was discharged on the 3/20/21 with Plavix. She saw her regular doctor yesterday and he diagnosed her with functional asplenia and to continue the Plavix. She is no longer having any symptoms after dissolving the blood clot.
60 2021-04-01 chest pain Four and a half hours after the first dose of Moderna my arm began to ache. A severe headache follo... Read more
Four and a half hours after the first dose of Moderna my arm began to ache. A severe headache followed. 12 hours post injection every joint in my body was in pain. This continued throughout the entire week. At 36 hours post injection I had severe chest pains. I went to urgent care and they ruled out any heart problems. The chest pains lasted for two hours. The migraine ended after 48 hours. The body aches ended after 6 days. I had the Covid 19 virus begging on 3/11/
60 2021-04-01 heart rate increased Fever 100 Elevated heart rate 93 bpm (normal 60 bpm) Headache Buzzing in the head Body aches and ch... Read more
Fever 100 Elevated heart rate 93 bpm (normal 60 bpm) Headache Buzzing in the head Body aches and chills No treatment. Symptoms subsided at 48 hours
60 2021-04-02 palpitations HEART PALPITATIONS, HEADACHES, VERTIGO, SLIGHT NAUSEA, LIGHTHEADED/SLIGHT DIZZINESS IM VERY CONCER... Read more
HEART PALPITATIONS, HEADACHES, VERTIGO, SLIGHT NAUSEA, LIGHTHEADED/SLIGHT DIZZINESS IM VERY CONCERNED ABOUT RECEIVING THE 2ND DOSE DUE TO THE PALPITATIONS. I WOULD APPRECIATE SOMEONE CONTACTING ME OR REFERING ME TO A SITE WHERE I CAN GET A CLEARER UNDERSTAND ON THIS CONCERN.
60 2021-04-03 hypertension pt after waiting a half hour informed the medical staff she did not feel good. pt received 2nd vacci... Read more
pt after waiting a half hour informed the medical staff she did not feel good. pt received 2nd vaccine in right arm at 5pm. at 530pm pt states she has headache and is flushed. pt at 540pm was further assessed and then treated by ems on scene with a cardiac monitor and iv due to high blood pressure. pt was transported to hospital at 620 pm for further treatment
60 2021-04-04 body temperature decreased, ischemic chest pain Redness, heat, swelling, itching rash down length of vaccine arm, hand and same side leg. Numbness ... Read more
Redness, heat, swelling, itching rash down length of vaccine arm, hand and same side leg. Numbness in shin and ankle same side leg. Redness and itching around same side eye. Heart pain 5 times in succession. Pain and stiffness in same side neck and shoulder. Facial and head itching. Temperature dropped to 95. Severe chills.
60 2021-04-04 ejection fraction decreased, chest pain, troponin increased chest pain beginning 11:00pm after vaccine given at 9:30am with subsequently confirmed cardiac ische... Read more
chest pain beginning 11:00pm after vaccine given at 9:30am with subsequently confirmed cardiac ischemia. There was associated shortness of breath and fatigue. Patient waited to call on 4/2/2021 and was seen in the office and subsequently sent to the ER after electrocardiogram was abnormal.
60 2021-04-04 palpitations, arrhythmia, chest pain Vaccine #1: Only the sore arm as described on the Fact Sheet. Vaccine #2: Stabbing anterior, poste... Read more
Vaccine #1: Only the sore arm as described on the Fact Sheet. Vaccine #2: Stabbing anterior, posterior, and lateral left thorax chest pain at approx. 3 hours post injection lasting 2-5 seconds. Cardiac arrhythmias at 10 hours post injection: I could feel the arrhythmias as they were about to start with fullness in my throat. Unable to detect radial pulse during episodes and no cardiac beats heard on auscultation. Complete compensatory pause noted per palpation and auscultation. Frequency of about two (2) episodes every 30-45 minutes for approximately three (3) hours, with gradual decrease in frequency over 24 hours. By 24 hours post to present none noted. During all of these episodes I was supine. At 72 hours post the axillary swelling and chest pain (not the same size as the stabbing pain) noted at 36 hours post had decreased from a full football in size to approx 1/2 a football. Captured a picture of that (the half-size football), but not the full-size event. Considerable abdominal pain to LLQ at approx 90-100 hours post vaccine #2 that persisted for 24+ hours.
60 2021-04-04 loss of consciousness Dizziness, passed out, diarea, throwing up, chills, headache, body aches
60 2021-04-04 loss of consciousness loss of conscious / Joint Pain / Headache / Muscle Aches/ Nausea / Fatigue / chills / Fever / Swel... Read more
loss of conscious / Joint Pain / Headache / Muscle Aches/ Nausea / Fatigue / chills / Fever / Swelling of arm with pain still recovering at home
60 2021-04-04 oxygen saturation decreased Confusion disoriented and Respiratory distress. Admitted to hospital as 24 he obviously
60 2021-04-04 fainting Fever and extreme lethargy. One episode of syncope. as of today 4/5/2021 I have a mouth sore and 4 ... Read more
Fever and extreme lethargy. One episode of syncope. as of today 4/5/2021 I have a mouth sore and 4 cold sores.
60 2021-04-04 fast heart rate, palpitations, fainting, heart rate increased, heart rate decreased, blood pressure increased, blood pressure fluctuation, blood pressure decreased Pt stated her "tongue felt thick" and felt her "heart racing" immediately after injection. Pt moved ... Read more
Pt stated her "tongue felt thick" and felt her "heart racing" immediately after injection. Pt moved to observation area and offered oral diphenhydramine, pt declined. Pt BP and HR were initially elevated at 168//80 and 129. BP decreased to 140/80 and HR to 100 after five minutes of observation. Pt reported gradual improvement with symptoms for 30 minutes, until reporting a sudden worsening of angioedema, "tingling all over", tachycardia, and syncope. RN administered 0.5 mg of epinephrine IM to L upper thigh and called 911 for ambulance transport. Pt reported some improvement in symptoms after administration of epi, but symptoms not resolved. RN considered administering second epi dose, but deferred when ambulance and EMTs arrived five minutes after first dose of epi. Pt transported to local hospital for further follow up.
60 2021-04-05 blood pressure increased Client received 1st dose of Moderna vaccine at 1305. At 1320 client reported it "feels hard to swall... Read more
Client received 1st dose of Moderna vaccine at 1305. At 1320 client reported it "feels hard to swallow." Client was also experiencing dizziness, and tongue numbness. Client VS at 1320 were O2 93% on room air, P 90, BP 190/102, and R 16. Client did not experience any SOB or difficulty breathing. Client had no visible swelling or hives. Client reports "being worked up about this all day" in regards to getting her vaccine. Client has HTN and is on medication, but reports drinking "12 cups of extra strong coffee and 1 Mtn. Dew" before getting her vaccination. Client BP at 1330 was 170/90 and at 1335 168/90. At 1330 client reports difficulty swallowing and tongue numbness had resolved. Client was kept on continuous pulse oximetry until symptoms resolved. Client advised to follow up with her PCP in regards to elevated BP. Client saw Dr. on 4/1/21 in regards to her BP and symptoms following vaccination. Per client her BP was 122/70 at her office visit. Client states that Dr. said it was okay to get her 2nd dose in 4 weeks, but that client "should lay off of the caffeine."
60 2021-04-05 chest discomfort Upon receiving the Moderna vaccination , I immediately (within a minute) experienced an all over bo... Read more
Upon receiving the Moderna vaccination , I immediately (within a minute) experienced an all over body tingling (it was an uncomfortable electric tingling running through my skin). I felt my chest tighten also. I felt hot and a little nauseous. The symptoms lasted 10 - 12 minutes. I have not experienced an adverse reaction to previous vaccines, ie shingles, flu....
60 2021-04-05 haemoglobin decreased, platelet count decreased Increased nausea and vomitting in the days following vaccine, also experienced lethargy, inability t... Read more
Increased nausea and vomitting in the days following vaccine, also experienced lethargy, inability to concentrate or follow a conversation. I requested IV fluids and lab draw from oncologist, hgb and plt were critically low requiring admission to the hospital for 5 days and 2 units on blood and 1 unit of platelets.
60 2021-04-05 palpitations She got the vaccine, that evening she had a headache. Then her arm started hurting to the point tha... Read more
She got the vaccine, that evening she had a headache. Then her arm started hurting to the point that she could not move it. On Thursday, 3/25/21 she was tired but functional. Then around 5:30 PM she started feeling really strange, odd, felt faint, got hot/cold, her heart was racing. She laid down as she was at a friends house, they checked her BP, blood sugar and her temperature and they were all normal at that point. Around 8:00 PM she got the nausea that would not stop and took Zofran. Around 9:30 she started throwing up. She then tried Phenergan and was not able to keep that down yesterday. Then she started running a temperature, and called her doctors office and told her what to look for and to call back if things got worse. They then got worse, called them back and then around 8:00 AM on Friday they told her to go to the hospital. When she got to the hospital they started checking things as her fever was higher, her liver enzymes, her thyroid, her kidneys, iron just started going off the page. Her fever then kept getting higher and higher and at one point it was documented at 104.8, and felt like her organs hurt. 11 days prior to this visit she had just had labs done and everything was normal. So due to the new findings everything was all elevated, so they checked her for an infection, COVID which was negative, but the intensity of the symptoms got to the point they were unbearable. She stayed in the hospital for 4 days, and the doctor came in and noted that she had a severe reaction to the vaccine. They told her to stay longer than the 15 minutes as they had some issues today, and told her that they had to call a medic for 4 other people that passed out, which made her wonder if they had a bad batch or not, and wonders how many people from that day got sick as well. She still has the most dreadful fatigue, headache and cannot walk from her house to the mailbox without feeling like she is going to faint and used to walking 2-4 miles daily. Wonders how long is this going to last and that this will pass and that she will be okay, or is she going to be permanently this way. She feels like she has a bad case of mono or something and cannot stay up and has to go to bed, and also has bouts of insomnia as well. The body aches are extreme and is taking pain medicine daily due to these symptoms, which she did not have prior to the vaccine. She got the vaccine, that evening she had a headache. Then her arm started hurting to the point that she could not move it. On Thursday, 3/25/21 she was tired but functional. Then around 5:30 PM she started feeling really strange, odd, felt faint, got hot/cold, her heart was racing. She laid down as she was at a friends house, they checked her BP, blood sugar and her temperature and they were all normal at that point. Around 8:00 PM she got the nausea that would not stop and took Zofran. Around 9:30 she started throwing up. She then tried Phenergan and was not able to keep that down yesterday. Then she started running a temperature, and called her doctors office and told her what to look for and to call back if things got worse. They then got worse, called them back and then around 8:00 AM on Friday they told her to go to the hospital. When she got to the hospital they started checking things as her fever was higher, her liver enzymes, her thyroid, her kidneys, iron just started going off the page. Her fever then kept getting higher and higher and at one point it was documented at 104.8, and felt like her organs hurt. 11 days prior to this visit she had just had labs done and everything was normal. So due to the new findings everything was all elevated, so they checked her for an infection, COVID which was negative, but the intensity of the symptoms got to the point they were unbearable. She stayed in the hospital for 4 days, and the doctor came in and noted that she had a severe reaction to the vaccine. They told her to stay longer than the 15 minutes as they had some issues today, and told her that they had to call a medic for 4 other people that passed out, which made her wonder if they had a bad batch or not, and wonders how many people from that day got sick as well. She still has the most dreadful fatigue, headache and cannot walk from her house to the mailbox without feeling like she is going to faint and used to walking 2-4 miles daily. Wonders how long is this going to last and that this will pass and that she will be okay, or is she going to be permanently this way. She feels like she has a bad case of mono or something and cannot stay up and has to go to bed, and also has bouts of insomnia as well. The body aches are extreme and is taking pain medicine daily due to these symptoms, which she did not have prior to the vaccine.
60 2021-04-05 palpitations Heart racing could feel heart beat in my head. Face ears and lips turned read. Labored breathing. Li... Read more
Heart racing could feel heart beat in my head. Face ears and lips turned read. Labored breathing. Light headed. Fatigue. Itchy all over.
60 2021-04-06 fast heart rate Systemic: Tachycardia-Medium
60 2021-04-07 chest discomfort In the observation area, shortly after receiving her 2nd dose of COVID-19 vaccine, she felt nauseous... Read more
In the observation area, shortly after receiving her 2nd dose of COVID-19 vaccine, she felt nauseous and went to the restroom where she vomited. Another patron reported to staff that someone was sick. A staff member caught patient exiting the restroom and escorted her back to the observation area. She reported chest tightness, nausea, felt clammy, foggy/lightheaded. Vitals were monitored for 45 minutes. 0856 BP 124/76 P 98 O2 94, 0900 BP 103/71 P 93 O2 95, 0904 BP 83/55 P 92 O2 95, 0908 BP 93/59 P 94 O2 94, 0911 BP 94/68 P 98 O2 96, 0917 BP 102/72 P 93 O2 97, 0923 BP 102/68 P 89 O2 97, 0933 BP 118/70 P 86 O2 96, 0935. Patient escorted out, reported feeling much better, her husband was transporting her. She was instructed to seek help if symptoms returned or worsened.
60 2021-04-07 chest pain, low blood oxigenation, pulmonary embolism, fast heart rate Patient presented to ED due to sudden onset of chest pain and dyspnea. Symptoms worsened with exerti... Read more
Patient presented to ED due to sudden onset of chest pain and dyspnea. Symptoms worsened with exertion and relieved with rest. She received 2nd dose of Moderna Covid-19 vaccine on 4/4/21 and began having left calf pain on 4/5/21. She was mildly hypoxic on room air with ambulation and tachycardic. Prior COVID 19 infection in December 2020. CTA showed bilateral moderate burden of disease and was found to have developed bilateral pulmonary emboli.
60 2021-04-07 chest pain Fatigue, fever over 100 degrees, nausea, sweating, cramps/diarrhea, vomiting, chest pain, This all ... Read more
Fatigue, fever over 100 degrees, nausea, sweating, cramps/diarrhea, vomiting, chest pain, This all lasted about 30 hours total.
60 2021-04-07 chest pain Sore Throat, runny nose, coughing (could also be allergies) came on 2 days after first shot - still... Read more
Sore Throat, runny nose, coughing (could also be allergies) came on 2 days after first shot - still having same symptoms (4/1 - present 4/8) Shoulder and Chest pain on Right Arm/Chest - 3 events in 3 hours, last one lasting 45 minutes
60 2021-04-08 chest discomfort dizziness, weakness, feeling loops tightness in face/upper chest (waves) rash on left upper torso st... Read more
dizziness, weakness, feeling loops tightness in face/upper chest (waves) rash on left upper torso started about 25 minutes after vaccine: lasted about 4 hours -loaded up wit zyrtec & pepcid for treatment 4 doses 10mg q6hr - 10mg BID x3
60 2021-04-08 chest pain Dizziness and Chest Pain
60 2021-04-08 loss of consciousness Pt arrived to vaccination clinic stating she had multiple allergies and after her shingles vaccinati... Read more
Pt arrived to vaccination clinic stating she had multiple allergies and after her shingles vaccination she had an allergic reaction. 3 RN's present in room during this time. Vaccination given and patient ambulated to observation location. Within 30 seconds patient started complaining of feeling dizzy, SOB, and passed out. Patient assisted to floor by 2 RN's while 3rd RN called RRT. Patient not responded to verbal commands. Pt with pulse and respiratory effort. Patient began shaking in seizure like activity. Oxygen applied at 4 L NC. Unable to get B/P or SPO2 due to shaking. Epi 0.3 mg administered SQ by RN. Patient began to mumble words and laughed at husband. RRT present and patient accompanied to stretcher and transferred to ER for evaluation. Report given to ED RN by Primary RN.
60 2021-04-08 platelet count decreased Bruising, red pin spots all over body. Went to ER. Very low platelet count.
60 2021-04-09 loss of consciousness, lightheadedness Patient blacked out on the way home after receiving the vaccine and was driving on the opposite side... Read more
Patient blacked out on the way home after receiving the vaccine and was driving on the opposite side of traffic/ patient blacked out again; feels faint each time she stands; chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Patient blacked out on the way home after receiving the vaccine and was driving on the opposite side of traffic/ patient blacked out again) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient blacked out on the way home after receiving the vaccine and was driving on the opposite side of traffic/ patient blacked out again) (seriousness criterion medically significant), PRESYNCOPE (feels faint each time she stands) and CHILLS (chills). On 01-Apr-2021, LOSS OF CONSCIOUSNESS (Patient blacked out on the way home after receiving the vaccine and was driving on the opposite side of traffic/ patient blacked out again) had resolved. At the time of the report, PRESYNCOPE (feels faint each time she stands) and CHILLS (chills) outcome was unknown. No concomitant medications reported by patient. Treatment of these events included Zyrtec and Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
60 2021-04-09 loss of consciousness I couldn't sleep because of the pain in my right arm. I sat on the side of the bed and felt dizzy. T... Read more
I couldn't sleep because of the pain in my right arm. I sat on the side of the bed and felt dizzy. The next thing I know, I'm waking up on the floor with my husband standing over me. I passed out twice. I was very woozy the rest of the day and stayed in bed. Took extra strength Tylenol (that did nothing to relieve the pain) All over body aches and fever over 100 degrees all day.
60 2021-04-09 fainting, loss of consciousness Patient reports experiencing chills starting 12 hours later and continuing all night, back pain, bod... Read more
Patient reports experiencing chills starting 12 hours later and continuing all night, back pain, body aches and fainted next day at 3pm after experiencing dizziness. Said she was unconscious for about 15 seconds. Feeling better now at time of reporting 4/10/21. Patient did not seek medical treatment for the incident.
60 2021-04-10 fainting, chest pain, low blood pressure, arrhythmia Nearly fainted twice on the bathroom floor; Postural hypotension; Left lower quadrant abdominal pain... Read more
Nearly fainted twice on the bathroom floor; Postural hypotension; Left lower quadrant abdominal pain which continued for 24 hours; Dumping water from her rectum for approximately 24 hours; swelling of the lymph nodes on right side that increased to the size of a foot ball; Unable to move arm due to swelling in the lymph nodes; stabbing pains in chest that lasted from one to five minutes/pains on left lateral/Pain in chest wall and into heck on the lymph track; Throat was swelling with irregular heart beats; full compensatory pause when the patient was listening to heartbeat with her stethoscope; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Nearly fainted twice on the bathroom floor) and ARRHYTHMIA (full compensatory pause when the patient was listening to heartbeat with her stethoscope) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ARRHYTHMIA (full compensatory pause when the patient was listening to heartbeat with her stethoscope) (seriousness criterion medically significant), CHEST PAIN (stabbing pains in chest that lasted from one to five minutes/pains on left lateral/Pain in chest wall and into heck on the lymph track) and PHARYNGEAL SWELLING (Throat was swelling with irregular heart beats). On 01-Apr-2021, the patient experienced LYMPHADENOPATHY (swelling of the lymph nodes on right side that increased to the size of a foot ball) and HYPOKINESIA (Unable to move arm due to swelling in the lymph nodes). On 04-Apr-2021, the patient experienced ORTHOSTATIC HYPOTENSION (Postural hypotension), ABDOMINAL PAIN (Left lower quadrant abdominal pain which continued for 24 hours) and DIARRHOEA (Dumping water from her rectum for approximately 24 hours). On 05-Apr-2021, the patient experienced SYNCOPE (Nearly fainted twice on the bathroom floor) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Nearly fainted twice on the bathroom floor), ARRHYTHMIA (full compensatory pause when the patient was listening to heartbeat with her stethoscope), ORTHOSTATIC HYPOTENSION (Postural hypotension), CHEST PAIN (stabbing pains in chest that lasted from one to five minutes/pains on left lateral/Pain in chest wall and into heck on the lymph track), PHARYNGEAL SWELLING (Throat was swelling with irregular heart beats), LYMPHADENOPATHY (swelling of the lymph nodes on right side that increased to the size of a foot ball), HYPOKINESIA (Unable to move arm due to swelling in the lymph nodes), ABDOMINAL PAIN (Left lower quadrant abdominal pain which continued for 24 hours) and DIARRHOEA (Dumping water from her rectum for approximately 24 hours) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment was not reported/ unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
60 2021-04-11 chest pain 3/23/2021 @ Vaccination drive through- pt received 1st dose of Moderna vaccine in L deltoid. Approx.... Read more
3/23/2021 @ Vaccination drive through- pt received 1st dose of Moderna vaccine in L deltoid. Approx. 5 minutes after vaccination @ 11:00am, pt reported R side chest pain increasing suddenly on pain scale 5-10. EMS personnel onsite assessed pt VS 153/90, HR 66, r -16 Pt stated she had not taken her b/p meds in AM. PT'S pain subsided. refused to be transported to hospital. Pt continued to to be observed during the next hour. No c/o chest pain upon leaving vaccination site.
60 2021-04-11 chest pain 3/23/2021 @ Vaccination drive through- pt received 1st dose Moderna vaccine in L deltoid. Approx. 5 ... Read more
3/23/2021 @ Vaccination drive through- pt received 1st dose Moderna vaccine in L deltoid. Approx. 5 minutes after vaccination @ 11:00 am, pt reported R side chest pain increasing suddenly on pain scale 5-10. EMS personnel onsite Assessed pt VS 153/90 HR 66. R-16 in AM pt's pain subsided. Refused to be transported to hospital. Pt continued to be observed during the next hour. No c/o chest pain upon leaving vaccination site
60 2021-04-11 chest pain I had a reaction after the first dose of the vaccine. I felt like there was a lump in my throat and ... Read more
I had a reaction after the first dose of the vaccine. I felt like there was a lump in my throat and my throat was scratchy. My throat was tingly and itchy. It lasted three hours but I take antihistamines. The palms of my hands were really red and a little itchy which happened on and off for a week. I felt a I also came down with the shingles which I am still recovering from after seven weeks. The shingles started about three and half weeks after my vaccine. My Chiropractor thought my rotator cuff was injured because my shoulder chest and left arm hurt. The pain was really intense. I started to get some spots on my shoulder and chest when I saw my doctor she diagnosed Shingles. I started and an Antiviral drug. The spots that had broken out first are still visible after seven weeks. I have been advised not to get the second dose but I am unsure whether I will.
60 2021-04-11 heart rate increased Pounding accelerated heart rate
60 2021-04-11 low blood oxigenation admitted to the hospital with recurrent hypoxemic and hypercarbic respiratory failure. discharged h... Read more
admitted to the hospital with recurrent hypoxemic and hypercarbic respiratory failure. discharged home. passed away at home after discharge.
60 2021-04-12 cardiac failure congestive, pulmonary embolism On February 5th, I received my second Moderna vaccine. Monday the 8th, I was working from home and ... Read more
On February 5th, I received my second Moderna vaccine. Monday the 8th, I was working from home and wasn?t feeling well. I went to lay down and was not able to. It was hard to breath. I got up, went to another room where there was a recliner and sat in it trying to catch my breath. It got harder to breathe. I had my husband call 911. I went to the ER, had a CT scan of my chest and was found to have ?extensive PE?s?, ground glass and signs of pneumonitis. I was admitted to the CICU for two days and was transferred for two days. I was told by my orthopedic surgeon that there was a high unlikelihood of PE?s developing from my ankle fracture 3 months later. I had home health care for approximately one month.
60 2021-04-12 cerebrovascular accident I had a stroke one week to the day from taking the moderna vaccine. It affected my entire left side... Read more
I had a stroke one week to the day from taking the moderna vaccine. It affected my entire left side. Had weeks of physical therapy and still not back to normal. I have a long road ahead of me with rehab.
60 2021-04-12 deep vein blood clot DVT of the right Leg
60 2021-04-12 hypotension, palpitations Fever, Headache, Rashes, Extreme Fatigue and Extreme low blood pressure. 77/44. Heart palpatations, ... Read more
Fever, Headache, Rashes, Extreme Fatigue and Extreme low blood pressure. 77/44. Heart palpatations, coughing, Purple eyes, Swollen eyes, throat and lymph nodes. Sore throat. My HRT pellets migrated around my body that were inserted in my buns.
60 2021-04-12 ischaemic stroke Symptoms: Loss of Short Term Memory for 7 hours Event: Ischemic stroke on right parietal superior co... Read more
Symptoms: Loss of Short Term Memory for 7 hours Event: Ischemic stroke on right parietal superior cortex 1.2cm Treatment: aspirin 325 mg 1 daily; atorvastatin 40 mg 1 daily Outcome: hospital stay, 2 days. Sent home for recovery. Follow up with Primary Care Physician in 1 week
60 2021-04-13 chest discomfort 1st evening fever 103, shortness of breath, heaviness in chest. 2nd day nausea and fatigue and body ... Read more
1st evening fever 103, shortness of breath, heaviness in chest. 2nd day nausea and fatigue and body aches, 3rd day diarrhea extreme fatigue, red rash, swelling, itching , hot to touch at injection site. 4th day chills, night sweats arm still the same, 5th day dizziness, vertigo and head ache. Body aches continuing and extreme fatigue, 8th day body tingling, my skin feels weird that's all I can say. It is hard to describe. Two weeks later I'm still extremely fatigued, dizzy especially bending over and moving head, General malaise feeling and shortness of breath upon exertion like exercising.
60 2021-04-13 hypertension Patient came in today 4/14/2021 report that she had an adverse reaction to her first covid vaccine. ... Read more
Patient came in today 4/14/2021 report that she had an adverse reaction to her first covid vaccine. It began on 03/21/2021, which is 4 days following her receiving her vaccine. She stated that she developed a rash on her back, stomach and upper arms on the 21st of March. Patient stated on 03/25/2021 she went to the Dermatologist who instructed her to take and prescribed her Prednisone and Benadryl and diagnosed her with contact dermatitis. On 04/09/2021 she developed severe head and neck pain and went to the ER. When she arrived at the ER her blood pressure was 150/100 and got as high as 195/150 per patient report. She stated they did an EKG per her request and gave her propanol. Per patient her Blood Pressure was still 150/100 when she was discharged from the ER.
60 2021-04-13 blood clot on 03/22/2021 I had a red inflamed area on left Achilles tendon area, off work for two days, negativ... Read more
on 03/22/2021 I had a red inflamed area on left Achilles tendon area, off work for two days, negative US for DVT I had twisted my knee on 03/29/2021, negative DVT MRI meniscus tear I got a blood clot behind my left knee on 04/04/2021 left calf started hurting on 04/01/2021, got intense on 04/04/2021 went to UC US was positive for DVT I have never had one, no health issues, was advised to report blood clot
60 2021-04-14 anaemia, haemoglobin decreased, palpitations Patient had normal side effects (vaccine on 4/7/2021) Wednesday and Thursday with fever and aches. W... Read more
Patient had normal side effects (vaccine on 4/7/2021) Wednesday and Thursday with fever and aches. Woke up Friday morning with fatigue and over the course of the next days developed shortness of breath, severe fatigue, and palpitations. Came into the ER a week later (4/14/2021) found to have significant anemia. Coombs test positive. Seen by hematology suspect autoimmune hemolytic anemia. Started on prednisone 1mg/kg. Will need at least weeks of treatment then tapering of steroids. Outpatient follow-up with hematology.
60 2021-04-14 body temperature decreased Headache, nausea, very cold - temp was 90.6 degrees.
60 2021-04-14 palpitations Awakened at 4AM by increased heart rate. 100 bpm. Lasted about one hour. Palpitations Repeated ever... Read more
Awakened at 4AM by increased heart rate. 100 bpm. Lasted about one hour. Palpitations Repeated every night for 5 days in a row, then went away. Each time it lasted about 1 hour.
60 2021-04-15 cerebrovascular accident Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASC... Read more
Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for an unknown indication. The patient's past medical history included Thrombectomy. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization, medically significant and life threatening). The patient was treated with Rehabilitation therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Per SD date of administration of the first dose of vaccine is either 22-feb-2021 or 28-feb-2021. To be checked on query response.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Per SD date of administration of the first dose of vaccine is either 22-feb-2021 or 28-feb-2021. To be checked on query response.
60 2021-04-15 haemoglobin decreased, cardiac failure congestive, heart failure Patient presented to with 4 day history of progressively worsening pitting edema and swelling in bil... Read more
Patient presented to with 4 day history of progressively worsening pitting edema and swelling in bilateral lower extremities. She reports mild shortness of breath. She also reports flank pain and dysuria. Cardiac murmur and rales noted on exam. Patient found to have a heart failure exacerbation and UTI. Patient is being treated with levofloxacin and furosemide and is admitted to the hospital.
60 2021-04-15 loss of consciousness Became light headed and nauseous; it went on for several hours. My husband says that, at one point, ... Read more
Became light headed and nauseous; it went on for several hours. My husband says that, at one point, I was "out of it" for a few minutes. Pretty sure I blacked out. Interest in eating returned the next day. Injection site still slightly sore, but that is not too unusual, I think. Sore throat yesterday and today. Took aspirin for the injection site pain for a couple of days, until I could raise my arm up over my head again.
60 2021-04-16 blood glucose increased 1st immunization 3/18/21 L arm slightly sore but nothing bad. No symptoms. 3/19/2021 L arm tender w... Read more
1st immunization 3/18/21 L arm slightly sore but nothing bad. No symptoms. 3/19/2021 L arm tender with large lump. No symptoms however took temp. 99.0 7:45pm 3/20/2021 Knot in arm is loosened up. Now I am sweaty and hot feeling 99.8 2:35am 98.7 4:40am 98.8 5:00pm 99.0 11:55pm 3/21/21 Arm feels better, but still have elevated temp. hot, sweaty 99.1 2:55am 3/22/21 Arm pain almost gone, still have elevated temp 99.1 2:17AM 99.1 10:55pm 3/23/21 Arm hardly sore at all, still hot, sweaty, elevated temp 99.1 9:15 pm Last day to take temp. After 3/24/21 sore arm gone, slept 14 hours on the 24th and after that getting better fast. It was like a mild version of COVID with the cough, fever & runs for the next few days but back to normal-ish on the 26th &27th. 2nd immunization 4/15/21 No side effects so far. Spoke too soon. Dry heaves, vomiting up the Gatorade I drank. Eating only Jell-O & Gatorade. Later in the evening able to eat small amounts of solid foods. Fever to touch, but unable to take temp because when I thought of it I had just drank cold Gatorade. 4/16/21 Unbelievably sore arm and lymph nodes in armpit. Lymph node started out the size of a golf ball but later in the day was so big I couldn?t raise or lower my arm. Could not sleep for more than an hour at a time. So exhausted but can?t sleep dur to pain. Fever right at 99 degrees. Some diarrhea, but not much since I am eating so little. Forgot to record time 99 ???? 4/17/21 BS is high spiked at 220 last night and maintaining 160-170 in AM. Still with the heat pad since it is the only thing helping with the pain. Headache back. But to a lesser degree than yesterday and the day before. If it goes to pattern, I should be better 9 days later (4/29/21) 99 5:30am As of this posting,(4/17/210 I still have several tender lymph nodes under my left arm and at injection site. Still have nausea, but vomiting has subsided. Loss of appetite is still an issue and I am controlling my blood sugar rise with additional fast-acting insulin. What a horrible experience. Fatigue is overwhelming; I have slept approximately 11-12 hours each night as able, though only in 1 hour spans due to the unbelievable pain in my arm and lymph nodes.
60 2021-04-16 fainting Moderna COVID-19 Vaccine: The PQCF was reviewed with the patient who stated that she was feeling ok ... Read more
Moderna COVID-19 Vaccine: The PQCF was reviewed with the patient who stated that she was feeling ok today: no cough, diarrhea, vomiting and didn't require a tetanus shot for an injury. The patient did state that she was allergic to Penicillin and that she had just completed a course of antibiotics Cipro 500mg for an UTI. After she was administered the Moderna vaccine 1st dose, the patient was advised to sit for a couple of minutes near the pharmacy area where she had just taken her shot while her husband was administered his vaccine and then they would be walked up together to the Post-Vaccination Sitting Area. The patient sat near the pharmacy for roughly 5-10 minutes and then walked over to one of the pharmacy Counseling windows to let us know that she was feeling funny and weird. No sooner than she uttered those words, she collapsed and fainted. 911 was called. Once conscious the patient stated that she truly wasn't feeling the best before getting the vaccine but wanted to go ahead and get her vaccine today. EMTs checked vitals. Her blood pressure and blood sugar were normal; however, her heart rate was low and skin turgor was poor. Her preliminary diagnosis before being transported to a nearby hospital was dehydration. I truly do not think that the vaccine caused her syncope spell but reporting since event occurred shortly after Moderna was administered.
60 2021-04-18 blood pressure increased, heart rate increased Within 5 minutes, it appeared tongue was swelling a bit. A metallic taste was also present. Next 3... Read more
Within 5 minutes, it appeared tongue was swelling a bit. A metallic taste was also present. Next 3 days, mild fatigue, low grade fever, headache and sore arm were experience. Day 4 light headedness and fatigue increased and grew progressively worse each day. Heartbeat & blood pressure elevated over normal, but not in dangerous zone. It felt like when I had anemia years earlier. Day 8 I went to urgent care, suspecting anemia. Blood test was normal, except for slightly lower sodium. Day 9 I followed up with regular doctor, and Thyroid test was ordered. It was normal. Day 10 tongue swelling and metallic taste improved, and other symptoms started to subside. As of day 18, all symptoms gone, I felt "normal" again and was able to resume regular activity and exercise routine.
60 2021-04-18 stroke 4/5/21: Patient admitted to ED at 12:55 PM (last known well 1AM) with symptoms suggestive of stroke ... Read more
4/5/21: Patient admitted to ED at 12:55 PM (last known well 1AM) with symptoms suggestive of stroke including: left side weakness, facial droop, slurred speech, dysphagia and fall x 3. NIH stroke scale = 7. Diagnosis: acute right MCA infarct (embolic stroke). Patient was not a candidate for TPA. Risk Factors: diabetes mellitus, hyperlipidemia, hypertension, smoking and hypercoagulable state due to systemic inflammation from second COVID-19 vaccine. Throughout her stay, dysphagia and slurred speech improved but patient still had residual weakness and headache. While inpatient, patient received DVT prophylaxis with Lovenox, rectal aspirin 325 mg, normal saline fluids, sliding scale insulin, analgesics as needed, Requip, and antihypertensives as needed. She also received stroke education, diabetes education, smoking cessation counseling, PT, OT, and speech therapy. A loop recorder implant was placed on 4/7. The patient fell while in the hospital on 4/8. 4/9/21: Patient was discharged to Inpatient Rehab approx. 8:30 AM on the following medications: -- acetaminophen (TYLENOL) 325 MG tablet Take 2 (two) tablets (650 mg total) by mouth every 6 (six) hours as needed --aspirin 81 mg chewable tablet Chew and Swallow 1 (one) tablet (81 mg total) daily . --atorvastatin (LIPITOR) 80 MG tablet Take 1 (one) tablet (80 mg total) by mouth nightly . --bisacodyL (DULCOLAX) 10 mg suppository Insert 1 (one) suppository (10 mg total) into the rectum daily as needed for constipation . --cyclobenzaprine (FLEXERIL) 10 MG tablet Take 1 (one) tablet (10 mg total) by mouth 3 (three) times a day as needed (Restless legs) . --enoxaparin (LOVENOX) 40 mg/0.4 mL Syrg Inject 0.4 mL (40 mg total) under the skin nightly for 20 days . --insulin glargine (LANTUS) 100 unit/mL injection Inject 5 (five) Units under the skin nightly . --insulin lispro (HumaLOG) 100 unit/mL injection Inject 0 (zero) Units to 15 (fifteen) Units under the skin at bedtime . -- insulin lispro (HumaLOG) 100 unit/mL injection Inject 0 (zero) Units to 30 (thirty) Units under the skin 3 (three) times a day before meals . --nicotine (NICODERM CQ) 21 mg/24 hr Place 1 (one) patch on the skin daily . --sulfamethoxazole-trimethoprim (BACTRIM DS,SEPTRA DS) 800-160 mg per tablet Take 1 (one) tablet by mouth every 12 (twelve) hours for 5 days . --traMADoL (ULTRAM) 50 mg tablet Take 1 (one) tablet (50 mg total) by mouth every 8 (eight) hours as needed --continue home doses of metformin, glipizide, bupropion, and omeprazole. --discontinue lisinopril.
60 2021-04-18 chest discomfort I got the injection on Tuesday, 4/13/2021. My left arm, the arm I got the injection, immediately sta... Read more
I got the injection on Tuesday, 4/13/2021. My left arm, the arm I got the injection, immediately started hurting after I got the shot. Starting on Wednesday, I had slight fever, congestion, felt discomfort in my chest, like pressure, and I felt slight discomfort in my right arm. Thursday I woke up with more pain in my right arm, and by 1:30, when I got off work, I had trouble even lifting my right arm. By Friday I was in excruciating pain and unable to move my right arm at all. My right arm is still currently swollen down to my wrist and my fingers on my right hand feel stiff.
60 2021-04-18 excessive bleeding low grade fever, headache for approx 24 hrs., body aches 24-48 hours, 5 days after injection heavy b... Read more
low grade fever, headache for approx 24 hrs., body aches 24-48 hours, 5 days after injection heavy bleeding from cut on my tongue. A small cut developed when eating and then bleed profusely for 2 1/2 to 3 hours. My blood wasn't clotting. That has never been a problem. Very heavy bleeding from a very small cut finally stopped after putting ice on it.
60 2021-04-18 loss of consciousness Severe stomach pain, passed out cutting chin, neck, bruised windpipe, vomiting and chillls
60 2021-04-18 loss of consciousness Sore arm started at 4 hours, starting at 8 hours: chills, fever 99.8, muscles aches, pains in feet, ... Read more
Sore arm started at 4 hours, starting at 8 hours: chills, fever 99.8, muscles aches, pains in feet, mid back, neck, burning pains in skin in linear pattern, felt faint in the middle of the night almost passed out when I got up. Next day April 13th - slept on and off most of the day, after a 3 hour nap woke up drenched in sweat, fever broke and then felt better. April 14th still felt worn out and weak. Neck discomfort on the side of the shot (left) still feel pressure and discomfort (Perhaps swollen cervical lymph nodes). Today (One week post vaccine) - feel a buzzing sensation on and off in left axillary lymph nodes and left breast (After the first dose left axillary lymph node and breast discomfort lasted for one week). Still feel more tired than usual.
60 2021-04-18 fast heart rate SVT requiring an ER visit Diltiazem IV Increase in metoprolol Clinic and cardiologist follow up
60 2021-04-19 nosebleed Second day second shot, chills, headache, nausea, 4 day after second shot, bleeding gums (never had ... Read more
Second day second shot, chills, headache, nausea, 4 day after second shot, bleeding gums (never had problems with my gums) nose bleed and bruising
60 2021-04-19 heart rate increased, cardiac arrhythmia Immediate rapid heart rate 120 bpm I sat down, put feet up, slow breathing, monitored heart rate fo... Read more
Immediate rapid heart rate 120 bpm I sat down, put feet up, slow breathing, monitored heart rate for 30 minutes. Heart rate slowed down to 70. I was light headed for about 3 hours. Having more pvc's or heart flip flops than usual.
60 2021-04-19 loss of consciousness Friday about 10am I started with chills by the time I got home I had a temp 0f 99.0. I had fever an... Read more
Friday about 10am I started with chills by the time I got home I had a temp 0f 99.0. I had fever and chills all day Friday. Saturday at 2:30 I was awakened with chills and a fever. I fell back to sleep finally woke back up at 5:30am....got up out of bed at 5:40. I was out in the kitchen at 5:45 I started to feel bad so I headed back to the bedroom to get my cell phone to call my sister to let her know that I was feeling strange but blacked out. Not quite sure how long I was out but I hit my head, knee and shoulder. After regaining conscious, I was able to get to my phone to call my sister for help. Due to my fever and chills we decided to not go to the ER. I went to my family doctor on Monday.......I have a concussion from passing out
60 2021-04-19 pallor Patient received the vaccine and while waiting for her 15 minute post vaccine observation period, sh... Read more
Patient received the vaccine and while waiting for her 15 minute post vaccine observation period, she stated that she felt a cool rush. Patient continued to wait and stated that the cool feeling would come and go. She appeared pale in color and stated she didn't feel well. At this point 911 was called and an ambulance service responded bringing patient to the hospital.
60 2021-04-20 chest discomfort Was fine Friday and Saturday after shot. Sunday and Monday had chills, sore in mouth, headache and ... Read more
Was fine Friday and Saturday after shot. Sunday and Monday had chills, sore in mouth, headache and body aches. Tuesday had chest tightening for a little while.
60 2021-04-20 chest pain One day after my 2nd Moderna shot I developed severe chest and back pain and was developing a frozen... Read more
One day after my 2nd Moderna shot I developed severe chest and back pain and was developing a frozen painful left shoulder (where I had an injury from my previous flu shot administration). It began very shortly after vaccination and by the 2nd day the chest, back and arm pain were so severe I was afraid I was having a heart attack so I had to go to the Emergency Room. It was not a heart attack, but told it was likely a fibromyalgia flare up combined with inflammatory reaction from the Covid vaccine. This has lasted for one month now, and is only beginning to reduce in severity due to anti inflammatory my physician prescribed for me.
60 2021-04-21 blood pressure decreased Patient received her vaccination at 9:30. At 9:45 she was dismissed as her observation time was ove... Read more
Patient received her vaccination at 9:30. At 9:45 she was dismissed as her observation time was over and she was feeling fine. At the exit of the clinic staff noticed she was staggering her walk. Staff braced her against the wall until a chair was brought to her. Patient reported feeling "lightheaded, faint and dizzy". After a few minutes patient stated she felt better. She was brought back to the observation area for direct observation of vitals and assessment of on site RN staff. Patient went in and out of being oriented to person, place and time. On site DO came to assess patient and 911 was called. Her BP briefly dropped to 98/54 before rebounding to 198/102. She had rapid, shallow breathing, moans of distress and body shaking. No medications were administered. No suspicion of airway obstruction. Time was approximately 9:45am-10:15 from symptom start and being transported by EMS.
60 2021-04-21 chest discomfort Extreme pain at injection site(right arm) Extreme pain at 1st dose injection site (left arm). Severe... Read more
Extreme pain at injection site(right arm) Extreme pain at 1st dose injection site (left arm). Severe headache. Stiff neck. Temperature 102.4. Severe chills. Rash on chest. Nausea. Cough. Chest tightness. Dizziness. Complete loss of appetite. Pain in both hands.
60 2021-04-21 heart rate increased, fast heart rate Fever starting 8 p.m. 4/19/2021 topping out at 102 degrees and breaking 4 a.m. on 4/21/2021. Chills... Read more
Fever starting 8 p.m. 4/19/2021 topping out at 102 degrees and breaking 4 a.m. on 4/21/2021. Chills and shivering started at 8 p.m. on 4/19/2021 ending 11:30 p.m. 4/19/2021. Tachycardia = 200 bmp started 3:00 a.m. 4/20/2021 lasting through 4:15 a.m. 4/20/2021. Throbbing headache during elevated heart rate. Bodyache lasting during time of elevated temperature. Extreme soreness at injection site.
60 2021-04-22 hypertension injection arm started to swell real bad; hand swelled really bad; injection arm turned red; injectio... Read more
injection arm started to swell real bad; hand swelled really bad; injection arm turned red; injection arm was bruising; blood pressure was really high; bleeding under her skin (getting larger everyday); right hand completely with blood under the skin; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE SUBCUTANEOUS (bleeding under her skin (getting larger everyday); right hand completely with blood under the skin) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no reported medical history). On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PERIPHERAL SWELLING (injection arm started to swell real bad; hand swelled really bad), ERYTHEMA (injection arm turned red), CONTUSION (injection arm was bruising) and HYPERTENSION (blood pressure was really high). In April 2021, the patient experienced HAEMORRHAGE SUBCUTANEOUS (bleeding under her skin (getting larger everyday); right hand completely with blood under the skin) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE SUBCUTANEOUS (bleeding under her skin (getting larger everyday); right hand completely with blood under the skin), PERIPHERAL SWELLING (injection arm started to swell real bad; hand swelled really bad), ERYTHEMA (injection arm turned red), CONTUSION (injection arm was bruising) and HYPERTENSION (blood pressure was really high) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: high (High) high blood pressure. The patient did not go to hospital, instead went to her primary care doctor who said that bleeding under her skin and it is getting larger everyday; there is a complete band around her right forearm about 4-5 inches wide and 20 inches long. The patient saw the paramedics, her PCP, as well as the nurse at the site, as well as her surgeon who recommended she should go back to PCP to get some bloodwork done to check if she is bleeding elsewhere. No treatment information was provided.; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of hemorrhage subcutaneous, and nonserious unexpected contusion, erythema, peripheral swelling, hypertension. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
60 2021-04-22 loss of consciousness Patient was in observation/waiting area, got up to tell my tech that she wasn't feeling well. My te... Read more
Patient was in observation/waiting area, got up to tell my tech that she wasn't feeling well. My tech called to me to have me assist the patient and I had her sit down and then as we were talking she lost consciousness. She was sitting so I had her head in my hands and she came back to consciousness in less then 10 seconds. I had the tech call 911 as soon as she passed out. I kept her talking and concentrated on her breathing until the emt's arrived and assessed her. She stayed with us for over an hour and her significant other arrived to pick her up. She called me later that evening, per my request, and she was feeling much better and had no further incidents, but was tired and feeling a bit off
60 2021-04-22 fainting After a night of mostly not sleeping and shivering (feeling cold and hot), I got out of bed at 7:00 ... Read more
After a night of mostly not sleeping and shivering (feeling cold and hot), I got out of bed at 7:00 am and fainted twice on my way to the bathroom. I knocked out a front tooth, pulled a muscle in my shoulder, and cut my face in several places.
60 2021-04-23 atrial fibrillation Atrial Fibrillation
60 2021-04-23 cerebrovascular accident They thought they were having a stroke; Facial paresthesia; The right side of their face felt numb, ... Read more
They thought they were having a stroke; Facial paresthesia; The right side of their face felt numb, like with paralysis; Their face was swollen; Right upper extremity paresthesia; Blurry vision; Dizzy; Nervous as hell; Felt like someone hit them with a gun in the right temple with Novocain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (They thought they were having a stroke), PARAESTHESIA (Facial paresthesia), HYPOAESTHESIA (The right side of their face felt numb, like with paralysis), SWELLING FACE (Their face was swollen) and PARAESTHESIA (Right upper extremity paresthesia) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced VISION BLURRED (Blurry vision), DIZZINESS (Dizzy), NERVOUSNESS (Nervous as hell) and FEELING ABNORMAL (Felt like someone hit them with a gun in the right temple with Novocain). On 14-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (They thought they were having a stroke) (seriousness criterion hospitalization), PARAESTHESIA (Facial paresthesia) (seriousness criterion hospitalization), HYPOAESTHESIA (The right side of their face felt numb, like with paralysis) (seriousness criterion hospitalization), SWELLING FACE (Their face was swollen) (seriousness criterion hospitalization) and PARAESTHESIA (Right upper extremity paresthesia) (seriousness criterion hospitalization). The patient was hospitalized from 14-Apr-2021 to 19-Apr-2021 due to CEREBROVASCULAR ACCIDENT, HYPOAESTHESIA, PARAESTHESIA, PARAESTHESIA and SWELLING FACE. On 11-Apr-2021, VISION BLURRED (Blurry vision), DIZZINESS (Dizzy), NERVOUSNESS (Nervous as hell) and FEELING ABNORMAL (Felt like someone hit them with a gun in the right temple with Novocain) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (They thought they were having a stroke), PARAESTHESIA (Facial paresthesia), HYPOAESTHESIA (The right side of their face felt numb, like with paralysis), SWELLING FACE (Their face was swollen) and PARAESTHESIA (Right upper extremity paresthesia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: normal (normal) Normal. In April 2021, Blood test: normal (normal) Normal. In April 2021, Echocardiogram: normal (normal) Normal. In April 2021, Lumbar puncture: negative (Negative) Negative for Lyme disease. In April 2021, Magnetic resonance imaging brain: normal (normal) Normal (2x). In April 2021, Ultrasound Doppler: normal (normal) Normal. In April 2021, X-ray: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant product use was unknown. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is requested.
60 2021-04-23 oxygen saturation decreased Rashes, hives and total face, neck, and torso and arms completely red as the hives grow. Several epi... Read more
Rashes, hives and total face, neck, and torso and arms completely red as the hives grow. Several episodes where it was so bad I had anaphylaxis requiring epinephrine injections with O2 sat down to 70! This went on every day for 3 1/2 weeks. I was already taking Allegra, Xzyzal, singularity, and famotidine to stabilize my mast cells. Cromolyn and Benadryl added.
60 2021-04-23 palpitations Vomiting, diarrhea, extreme headache, fever, racing heart, joint pain and exhaustion for 36 hours.
60 2021-04-24 hypertension Had chills fever and nausa now have very high bp almost all the time even though taking meds 3/10
60 2021-04-24 palpitations first racing heart, chills, aching muscles, headaches, nausea, vomiting, feaver
60 2021-04-25 pulmonary embolism Acute bilateral pulmonary embolus
60 2021-04-26 fluid around the heart Hospitalized: 3/13-3/22/21. Pericardial effusion, pleural effusion. Have had 3 thoracentesis as outp... Read more
Hospitalized: 3/13-3/22/21. Pericardial effusion, pleural effusion. Have had 3 thoracentesis as outpatient since release from hospital: 4/8/21 (removed 800ccs fluid), 4/19/21 (removed 1400ccs fluid), 4/26/21 (removed 1500ccs fluid). Scheduled 4th thoracentesis for 5/3/21 - have appt with thoracic surgeon on 5/13/21.
60 2021-04-27 chest discomfort Patient called nurse triage on 4/26 received the Madura vaccine on 4/22 and approximately 24 hours ... Read more
Patient called nurse triage on 4/26 received the Madura vaccine on 4/22 and approximately 24 hours later pt developed tightness in pt's chest and difficulty breathing; pt did have an allergic reaction to a pneumonia vaccine the past; pt currently on 2 L of O2 at HS ; pt woke up with sob and breathing difficulties that improved dramatically once pt used her nebulizer treatment. Patient is inpatient at Hospital. Patient called nurse triage 4/27/21 States she has had a bad headache. States she had moderna shot and has had a bad headache. She is currently at hospital and was somehow sent to triage incorrectly
60 2021-04-27 hypertension Swollen red rash upper left arm, itchy lasted 5 days . Also experienced numb tingly feelings in both... Read more
Swollen red rash upper left arm, itchy lasted 5 days . Also experienced numb tingly feelings in both hands, arms & lips - still experiencing these symptoms to a lesser degree. Felt flush - like blood pressure was up ( FYI I have low blood pressure) and lite headed at times - a feeling of being a little off On the 3rd day had some sharp pains in my left are
60 2021-04-28 cerebrovascular accident, transient ischaemic attack About 9 am, April 14, after breakfast, some fatigue and dizziness, a feeling of nausea, then tingli... Read more
About 9 am, April 14, after breakfast, some fatigue and dizziness, a feeling of nausea, then tingling in face, then numbness, followed by numbness in left arm, and finally numbness in leg. Whole episode was probably about an hour. Numbness on left side lasted maybe 20 minutes, possibly more. (The day before-April 13 -- I had tingling in the face and arm but it resolved almost immediately, also after breakfast.) Numbness of left arm returned for about 10 minutes that night while in hospital, but resolved except for remaining tingling in left hand.
60 2021-04-28 loss of consciousness within about 15 hours i had fever and chills, nausea and emesis, rigors, lasting 3 days. I am uninsu... Read more
within about 15 hours i had fever and chills, nausea and emesis, rigors, lasting 3 days. I am uninsured, and did not seek medical care. I believe I may have had a seizure? brief loss of consciousness? something... I had NO INTENTION of getting second dose of vaccine, because i had covid, and THE SCIENCE say i dont need a vaccination. Some countries are recommending ONE vaccine for someone who has had Covid. But then my work said it would be mandatory. So i got the second dose. And i lost a lot of money missing work. This is BS that we cant get out appropriate information .."follow the science" Give me a break. You should have to pay me for this but of course youre off scott free and i still feel like dying.
60 2021-04-29 deep vein blood clot Leg pain resulting in a DVT in the left popliteal vein 10 days after 1 vaccine given to patient.
60 2021-04-30 chest pain Developed chest pain within 18 hours of vaccine. Diagnosed with pleurisy, and treated with 16 day pr... Read more
Developed chest pain within 18 hours of vaccine. Diagnosed with pleurisy, and treated with 16 day prednisone course. Symptoms subsided within 14 days.
60 2021-04-30 chest pain 3 days after 2nd vaccine shot I started experiencing sporadic chest pain and a feeling of being ligh... Read more
3 days after 2nd vaccine shot I started experiencing sporadic chest pain and a feeling of being light headed. The next day I still had the same symptoms so I described them to my doctor. She recommended going to a urgent care facility. I was diagnosed with 2 small blood clots - one in each lung. I'm on anti-coagulants for the next 6 months.
60 2021-04-30 heart rate increased Swollen/red/painful arm, headache, rapid heart rate, chills, metallic taste in mouth, hives on arms ... Read more
Swollen/red/painful arm, headache, rapid heart rate, chills, metallic taste in mouth, hives on arms & legs, restless sleep.
60 2021-04-30 lightheadedness After my first shot, I was very tired and did not feel very good for about 10 days. My arm was also ... Read more
After my first shot, I was very tired and did not feel very good for about 10 days. My arm was also very, very sore. In addition, I had GI issues (lots of loose stools and some cramping) within the first six hours of taking the first dose. Those symptoms went away fairly soon, but when I ate dried cranberries again the same thing occurred so I think that might have been the issue. Around April 11th, I almost passed out twice in the night when I got up to go to the bathroom and I did not feel very good. I was in an office two days before where the staff had been fully vaccinated, but two of the staff were not wearing masks and I overheard one of them saying they had not been feeling good. I felt fine on the date of my second vaccine on April 20th so I went in for my shot. Right after my first shot I felt fine. However, about eight to 10 hours later, I started running a temperature, had chills, terrible muscle aches, felt terrible generally, and started having ringing in my ears. All of my symptoms got much worse and I am sure my fever was at least 102 , but I never took it until my chills were better and at that point it was 101. I then took 500 mg of Tylenol and within about three hours my fever was reduced to 99. In about 30 hours, my fever was gone and I felt better, but was still very tired and had ringing in my ears. It has been almost two weeks since my second shot and I still have ringing in my ears and it is worse when I am lying down or am quite. I am also a little more tired than usual and my insomnia is worse than usual. My main concern is the ringing in my ears.
60 2021-04-30 pulmonary embolism Patient received first Covid Moderna vaccination on 4/5/21 and on Thursday 4/8/21 was admitted to th... Read more
Patient received first Covid Moderna vaccination on 4/5/21 and on Thursday 4/8/21 was admitted to the hospital with a pulmonary embolism. She was released and put on Eliquis. The patient has been unable to reach via phone.
60 2021-05-04 chest discomfort Patient called on 5/5/21 and stated she had an adverse reaction to the covid vaccine. She said she g... Read more
Patient called on 5/5/21 and stated she had an adverse reaction to the covid vaccine. She said she got the shot on Tuesday and on Wednesday she started feeling bad. Thursday, she had no voice which has lasted for one month. Friday her bones began hurting and between Friday and Sunday she started having head congestion, chest heaviness, and on Sunday she started running a fever at nighttime only that lasted for 3 nights. She said all symptoms have resolved with the exception of a clear voice.
60 2021-05-05 palpitations palpitation, 1-2 times a day, started after the 2nd dose.
60 2021-05-05 fainting Patient presented to the ED on 3/6/21. Patient presented to the ED on 3/9/21 and was subsequently ho... Read more
Patient presented to the ED on 3/6/21. Patient presented to the ED on 3/9/21 and was subsequently hospitalized for 5 days. Prinicpal problem was syncope and collapse. He was diagnosed with elevated brain natriuretic peptide and pleural effusion. These visits are within 6 weeks of receiving COVID vaccination.
60 2021-05-06 fainting Sweating, nausea, weakness, tingling in extremities, syncope. Estimate 2-3 minutes of symptoms befor... Read more
Sweating, nausea, weakness, tingling in extremities, syncope. Estimate 2-3 minutes of symptoms before fainting, then regained consciousness after about 5-7 minutes.
60 2021-05-07 low blood oxigenation Low blood oxygen as measured with wearable pulse Ox device. Starting at approximately 13 hours afte... Read more
Low blood oxygen as measured with wearable pulse Ox device. Starting at approximately 13 hours after second dose, blood oxygen stayed in the 80-89% range. The following day, daytime pulse ox was measured at 85% (never that low during the day). I feel fine, but I have never seen low blood ox as a side effect.
60 2021-05-09 fainting Patient exhibited almost instantaneous syncope and seizure-like limb movement. Patient was attended ... Read more
Patient exhibited almost instantaneous syncope and seizure-like limb movement. Patient was attended immediately by Nurse staff, given O2 via NC @ 4lpm. Patient regained consciousness after approximately 1 minute, was moved to an observation area and monitored for 30 additional minutes w/out any other complications or incidents. Please note that the patient was given Benadryl prior to injection as she self-reported multiple allergies.
60 2021-05-10 fibrin d dimer increased Right leg swelling, redness and pain. patient was evaluate for deep vein thrombosis and was negativ... Read more
Right leg swelling, redness and pain. patient was evaluate for deep vein thrombosis and was negative for this.
60 2021-05-10 hypotension, heart rate increased Pt states she had a very rapid heart rate and went to ER. Hypotension with standing and rapid heart ... Read more
Pt states she had a very rapid heart rate and went to ER. Hypotension with standing and rapid heart rate were main symptoms. Did have a rash on her leg. Spent 1 night in ER. Has Echo cardiogram scheduled.
60 2021-05-11 chest pain chills, headache, nausea, chest pain, shortness of breath,, cough, loss of smell, dizziness, blurry ... Read more
chills, headache, nausea, chest pain, shortness of breath,, cough, loss of smell, dizziness, blurry vision
60 2021-05-11 loss of consciousness, fainting Syncopy, hit my head, out for approx 5 minutes. Went to the ER, had a head CT which showed orbital ... Read more
Syncopy, hit my head, out for approx 5 minutes. Went to the ER, had a head CT which showed orbital fractures from the fall.
60 2021-05-11 loss of consciousness Woke up at 6 AM, got into shower.. passed out, woke up then called out for my boyfriend to help. He ... Read more
Woke up at 6 AM, got into shower.. passed out, woke up then called out for my boyfriend to help. He ran into the bath to assist me and said that I passed out again and had no breath. I do remember having a difficult time breathing before I went down. He proceeded to call an ambulance which brought me to the ER. All which resulted in a reaction from the Modern shot. I felt perfectly fine after the shot the day of but not the following morning and the day after that as well. In my 60 years I don't remember ever passing out. Ironically the morning I passed out I was to go and have blood work done for my annual physical which is tomorrow 5/13/21. We shall see what the results are...
60 2021-05-17 loss of consciousness Massive vertigo attack; Severe migraine; can't go anywhere; pain medication wasn't working at all; P... Read more
Massive vertigo attack; Severe migraine; can't go anywhere; pain medication wasn't working at all; Pain; couldn't eat anything down; eye was so swollen; Passed out right after the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out right after the injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out right after the injection) (seriousness criterion medically significant). On an unknown date, the patient experienced VERTIGO (Massive vertigo attack), MIGRAINE (Severe migraine), MOBILITY DECREASED (can't go anywhere), DRUG INEFFECTIVE (pain medication wasn't working at all), PAIN (Pain), FEEDING DISORDER (couldn't eat anything down) and EYE SWELLING (eye was so swollen). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out right after the injection), VERTIGO (Massive vertigo attack), MIGRAINE (Severe migraine), MOBILITY DECREASED (can't go anywhere), DRUG INEFFECTIVE (pain medication wasn't working at all), PAIN (Pain), FEEDING DISORDER (couldn't eat anything down) and EYE SWELLING (eye was so swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant list is provided. Treatment information was not provided. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
60 2021-05-18 loss of consciousness, atrial fibrillation Sudden episode of afib with rvr needing to go to the ER. Passing out, confusion, shortness of breath... Read more
Sudden episode of afib with rvr needing to go to the ER. Passing out, confusion, shortness of breath. Resolved on own approximately 2 hrs followed by extreme fatigue and headache for 2 days. Still experiencing moderate to heavy fatigue and heavy sleepiness throughout the day.
60 2021-05-19 hypertension She got her vaccine, had no reactions. She woke up on 5/12/21 and had extreme headache, blood pres... Read more
She got her vaccine, had no reactions. She woke up on 5/12/21 and had extreme headache, blood pressure was high, nausea and vomiting, extreme pain behind her eyes, blurry vision. Later in the afternoon she had diarrhea. She called her PCP that evening and he prescribed Ondansetron (Zofran). On Thursday she continued to have the blurred and double vision with some nausea and dizziness and headaches which have been on-going, especially on the left side of her head. She went to the ER on Friday evening 5/14/21 where her BP at it's highest point was 195/126 and a pulse of 99. They started doing some actions to determine if she was having a stroke. They did a CT scan and gave her medications to get her BP down, started an IV. She was then admitted to HCF that evening. They kept her overnight and did an MRI on 5/15/21, had to start wearing an eye patch on her left eye due to dizziness and was not able to walk without covering the one eye and needed assistance to walk across the room. Everything was clear on the MRI and CAT scan. She saw two resident internist and then she saw a neurologist while being in the hospital. The neurologist diagnosed her with left third nerve palsy as a result from the vaccine and the high BP. They released her that evening with instructions to see an Ophthalmologist the following week, which she did on 5/17/21 and saw Dr. He concurred with the neurologist diagnosis and felt that there was really nothing that they needed to do and for it to run it's course and let it heal which will take anywhere from 2 weeks to 4 months. She was informed to continue to wear the eye patch until the dizziness and double vision improve. There is pain still behind the left eye, and still has high BP and have prescribed medications for that. Her PCP started her on Amlodipine/HCTZ 10/12.5 mg. She then ended up in the ER again last night on 5/19/21. They put her on fluids as she started vomiting again and could not keep any of the medications down that she was prescribed. So they gave her fluids and started a steroid in the IV fluids to help with the pain and inflammation behind her eye, as well as headache medications as well. She was then sent home last night and now the pain in her eye is about a 5 since receiving the steroids. She was also started on Prednisone 20 mg to start today as when she was in the ER they told her to start that. She has not had any nausea or vomiting today, and seems to be OK, but is still taking the Zofran for this. She was able to eat a little bit today and hold it down, but has not had much in the way of an appetite since receiving the vaccine.
60 2021-05-23 heart rate abnormal 5/21: aches that worsened into the night 5/22: 11 am- feeling faint, extreme N/V, shivering, numb ha... Read more
5/21: aches that worsened into the night 5/22: 11 am- feeling faint, extreme N/V, shivering, numb hands halfway up forewarm, abnormal HR; 5 pm - feeling resolved 5/23-24: "feeling off" w/out the above or new sxs took 2 tab bayer 500 mg throughout ; stopped taking on Saturday
60 2021-05-23 fainting approx 18 - 19 hours after shot, having had arm soreness, tiredness and low grade fever, woke up in ... Read more
approx 18 - 19 hours after shot, having had arm soreness, tiredness and low grade fever, woke up in morning with sweats and headache. Got up to get drink in kitchen to wash down Advil with, got dizzy, fainted and fell to floor. Time down unknown but very short duration. Stood up with dripping sweat and felt like was going to vomit. Had dry heaves but did not vomit. Rest of day tired and sore, woke up next morning perfectly fine and feeling good.
60 2021-05-25 fluid around the heart Cough, went to the Dr. for breathing trouble. I have not been able to walk with out sitting down to... Read more
Cough, went to the Dr. for breathing trouble. I have not been able to walk with out sitting down to get so I can breath, I was told that I now have fluid with my heart. My feet have been swealing up so bad, I feel sick all the time now.. If I knew this would happen i would not have gotten the vaccines.
60 2021-05-26 chest discomfort, palpitations, heart rate increased eight hours after vaccination felt very sick, indisposed; palpitations; eight hours after vaccinatio... Read more
eight hours after vaccination felt very sick, indisposed; palpitations; eight hours after vaccination felt very bad; felt something in the chest like a tremendous pressure; Heart Beat was 76 and in a second raised to 151-152; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (eight hours after vaccination felt very sick, indisposed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (eight hours after vaccination felt very sick, indisposed) (seriousness criterion hospitalization), CHEST DISCOMFORT (felt something in the chest like a tremendous pressure), HEART RATE INCREASED (Heart Beat was 76 and in a second raised to 151-152) and FEELING ABNORMAL (eight hours after vaccination felt very bad). On an unknown date, the patient experienced PALPITATIONS (palpitations). The patient was hospitalized for 5 days due to MALAISE. At the time of the report, MALAISE (eight hours after vaccination felt very sick, indisposed), CHEST DISCOMFORT (felt something in the chest like a tremendous pressure), HEART RATE INCREASED (Heart Beat was 76 and in a second raised to 151-152) and FEELING ABNORMAL (eight hours after vaccination felt very bad) outcome was unknown and PALPITATIONS (palpitations) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate: 76, 151-152 (Inconclusive) 76, 151-152 beats/min. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient went to emergency and was hospitalized for 5 days. Treatment details included acetylsalicylic acid for the blood flow and heart. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Significant; additional events added with details. Case upgraded to serious.; Reporter's Comments: .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
60 2021-05-29 heart rate increased Rapid pulse 150-160
60 2021-05-31 inflammation of the pericardium pericarditis
60 2021-06-01 blood pressure increased Elevated blood pressure and headache. 2 mos Blood pressure still elevated and now on bp medicine
60 2021-06-01 blood pressure increased high blood pressure
60 2021-06-01 nosebleed At. 10 PM I rolled over in bed and had right hip pain. At about 11:30 PM, developed severe spasm in ... Read more
At. 10 PM I rolled over in bed and had right hip pain. At about 11:30 PM, developed severe spasm in the pyriformis region that ran all the way down to my foot. The pain was so severe, I thought I was going to faint. Stood up to try to relieve the "cramp". The nerve going down my leg to my foot felt like it was being strangled to death. My husband was trying to help me stand up and rubbing the leg. There was an additional cramp on the lateral side of my calf and it felt like it was squeezing the nerves in my foot. By the next morning I had numbness in my right foot in the big toe, in the area underneath the toes and the skin on top of my foot around my big toe. Took a cyclobenzaprine and norco with no relief. The pain and spasm continued until some relief on 1/24/2021. Tried heating pad, vibrating massager, and muscle rubs also. I could not walk even 20 feet without having to sit down as the pain was so bad. Called my employer who is a physician on the 22nd and she prescribed prednisone, and gabapentin 300 mg tid. Nothing stopped the pain until mid day on the 24th. Went to work on the 25th and 26th but on the 27th the pain came back. During this time I am even taking my heating pad and massager to work. The pain on the 27th wasn't as bad and was able to work on the 28th but spent the rest of the weekend on the heating pad in the recliner. I was sleeping in the recliner the whole time as it was more comfortable. This is related to the first shot. Was driving home from work on 2/1/2021 and had a nose bleed that was so bad and I couldn't get it to stop so I had to call my husband to come pick me up as I couldn't drive and hold pressure and add tissues. It took us an hour to get it to stop. My car both the inside and where I got out of the car to get more tissues looked like a blood bath. My last nose bleed before that was probably age 6. I started seeing a chiropractor on 2/2/21 and have spent a fortune since then with PT, medications, chiropractor visits-(the only thing that gives some relief), and other expenses. I still have problems with my right hip and leg pain and numbness on the right lateral area of my calf and my right foot. It is changing the way I walk and I have developed 3 corns that I am treating due to not being able to feel my foot in areas and causing friction on the side of my foot. I got my second Moderna shot on 2/18/2021 and that weekend some on the pain in my leg returned but not as severe. The major side effect was an electric like jolt going off continuously in my right big toe. Interesting as that is about the only thing I have felt in my right big toe since the first vaccine. I again experienced an attack like the first but far worse on 5/6/2021. I stood up after eating dinner and my back had started hurting. I took a cyclobenzaprine and my usual medications, muscle rub, and went to bed. When I awoke on the 7th and tried to stand up my right leg was in excruciating pain when I tried to walk on it. The pain was worse than the first time. I could not walk. Started back on prednisone and was taking norco with absolutely no relief. I could not walk even 5 steps to try to go to the bathroom. I literally had my husband help me into a crawl and I crawled to the bathroom. We then got a wheelchair and I was in the wheel chair for about 10 days. I saw the chiropractor and my physician. He gave me percocets and increased my neurontin to 400 mg tid and prednisone. This was in addition to the cyclobenzaprine tylenol and ibuprofen. I knew I could not go to work. My doctor gave my three weeks off and I applied for temporary disability. Little did I know I would need every day of it. I was referred to pain management and on 5/26/2021, I had my first spinal injection. It reduced the pain by about half. I have another injection scheduled for 6/16/2021. I went back to work on 6/1/2021 but by the time I came home I was in pain even though I am still taking the neurontin, cyclobenzaprine 5 mg, tylenol arthritis, and ibuprofen. I don't take the percocet if working. I am concerned that this pain may be permanent and my employer is not going to be happy if I need 3 weeks off of work every 6-8 weeks. My plan right now is to try to work but I do realize that I very well may need to apply for permanent disability. I work as a nurse practitioner and it is really hard when my foot is numb and I ham having such severe nerve pain, hip pain and sometimes back pain to recommend getting COVID shots.
60 2021-06-02 lightheadedness Patient was given the wrong dosage. She was given a double dose of vaccine. Patient was instantly ... Read more
Patient was given the wrong dosage. She was given a double dose of vaccine. Patient was instantly light-headed. She has diabetes and had not eaten. Provider feels it was a vagal response instead of the vaccine reaction. Patient was monitored for 1 hour until symptoms resolved. Patient was contacted this afternoon, she is feeling much better.
60 2021-06-03 cerebrovascular accident Hospitalized about 2 months after the second dose of Moderna for stroke
60 2021-06-03 chest pain, fluid around the heart Admission to hospital with pericardial effusion and pleural effusions on 4/10/2021. Also with chest... Read more
Admission to hospital with pericardial effusion and pleural effusions on 4/10/2021. Also with chest pain. The patient was having some subacute systemic symptoms of fatigue, chest pain, dyspnea that predated the vaccine by more than a month.
60 2021-06-03 blood clot, deep vein blood clot Only nine days after my second Moderna shot, I broke my ankle. I then had to wear an immobilizing bo... Read more
Only nine days after my second Moderna shot, I broke my ankle. I then had to wear an immobilizing boot for 5-6 weeks. Despite taking one baby aspirin a day during the immobilization period, I developed a blood clot in my paroneal calf vein 5 weeks into the immobilization. I am wondering if the proximity of my immobilization to my Moderna vaccination put me at an increased risk of developing a blood clot.
60 2021-06-06 heart flutter, chest pain First shot red, lumpy hot arm for 3 days. A week and half later I got pounding cluster headaches for... Read more
First shot red, lumpy hot arm for 3 days. A week and half later I got pounding cluster headaches for 3 days. Second shot I was exhausted and dehydrated the next day. 2 week later and until now I keep getting heart flutterings and chest pain that comes and goes.
60 2021-06-06 chest discomfort When patient came in for 2nd shot, she said after the 1st shot , 2-3 weeks later, she had severe che... Read more
When patient came in for 2nd shot, she said after the 1st shot , 2-3 weeks later, she had severe chest tightness and difficulty breathing, she also had fever, chills, body aches. Due to the severity of the breathing and chest tightness she explained, the 2nd shot was denied.
60 2021-06-06 blood clot, hypertension, cerebrovascular accident, blood pressure increased, blood clot in the brain She got her vaccine, she wasn't feeling good right there and didn't know what it was going to progre... Read more
She got her vaccine, she wasn't feeling good right there and didn't know what it was going to progress to. She then at 2:00 AM the next morning she rolled out of the bed and fell to the floor and got stuck between the bed and was not able to stand up, and crawled down 14 stairs and then couldn't move. She could not tell him why she couldn't and she was not able to stand up (large women). Her husband did not see any signs of stroke. They called his son and noticed that her face was sagging and he said that it looked like a stroke. They called the paramedics and they sent her to hospital and she was flown to Clinic and diagnosed with a stroke. She had surgery and they tried to remove the blood clot and her blood pressure went high and they cut a huge part of her skull to remove the pressure, but not able to remove the clot that he is aware of. She is in rehab right now, and it's not really showing any signs of promise. She has a lot of stroke symptoms of being combative and she has a blood clot that has moved to her arm as well. She had 6 blood clots on her brain when they went into it, and now has blood clots in each arm. She is aware of her surroundings to some degree and thinks that she is somewhere else and feels like she has wet herself. Her husband said that the rehab does not look promising. She is still in the hospital and they are having a meeting tomorrow regarding how long they feel she may be there. She has very little headway in rehab. She cannot move her left side, hand or leg. She is able to move her right side though. Husband feels it has destroyed her life and it will be a miracle if she comes out of it.
60 2021-06-07 chest pain Significant flare up of both Lupus and PMR symptoms. - joint pain, exhaustion, proteinuria, swelling... Read more
Significant flare up of both Lupus and PMR symptoms. - joint pain, exhaustion, proteinuria, swelling in fingers, chest pain (on two occasions), and increased shoulder, arm, hand, and hip pain.
60 2021-06-09 loss of consciousness, transient ischaemic attack, fainting nauseous, vomited, faint, then ambulance went unconscious within 15 minutes of vaccine. Then one we... Read more
nauseous, vomited, faint, then ambulance went unconscious within 15 minutes of vaccine. Then one week later inverted T waves and hospitalized, recovered then about a week or two later Transient ischemic attack unable to speak recovered. then have been having abdominal pain/pelvic pain.
60 2021-06-09 fluid around the heart I developed pericardial effusion on Feb. 23 and had 750 ml of fluid removed from my heart. On April ... Read more
I developed pericardial effusion on Feb. 23 and had 750 ml of fluid removed from my heart. On April 27 another pericardial effusion developed and I had to have surgery to have a pericardial window created.
60 2021-06-09 superficial blood clot Thee days after shot had large blood clot (superficial ) in rt leg back of knee
60 2021-06-10 heart failure Shortness of breath began the first week of April. Thought I had caught Covid. Shortness of breath b... Read more
Shortness of breath began the first week of April. Thought I had caught Covid. Shortness of breath became increasingly worse throughout the month of April. Could not breathe at night. Went to emergency room May 5. Diagnosed heart failure 30% function. No known medical issues before vaccination. Currently wearing defibrillator. Kidney function stage three. Had a very active busy lifestyle, upstairs apartment Before vaccination. Now fighting for my life.
60 2021-06-10 palpitations Day one thru three pain at injection site and swelling. Painful arm and shoulder and could not slee... Read more
Day one thru three pain at injection site and swelling. Painful arm and shoulder and could not sleep on that side for two nights. After pain and swelling subsided, had heart palpitations, and some shortness of breath on evening of night four. Event lasted about 15 minutes. Was sitting up in chair so stayed put until breathing normalized and palpitations diminished and heartbeat normalized. No history of heart palpitations before.
60 2021-06-10 troponin increased, heart attack, chest pain, chest discomfort 4/14/21 12 hours post shot extreme dyspnea lasting 7 weeks now. Dizzy light headed.Emergency room vi... Read more
4/14/21 12 hours post shot extreme dyspnea lasting 7 weeks now. Dizzy light headed.Emergency room visit 4/17/21 blood work indicated increase troponin and potential blood clot in lung. Heart attack 4- 27-21. Second ER visit 5/8/21 which showed additional increase in troponin levels. Second heart attack on 5/22/21. Intense back pain between shoulder blades over shoulders and on chest. Additional squeezing in chest and neck pain.
60 2021-06-13 fast heart rate, chest discomfort PATIENT CLAIMS THAT A FEW HOURS AFTER VACCINATION SHE HAD FEVER, CHILLS AND BODY ACHES. AFTER SLEEPI... Read more
PATIENT CLAIMS THAT A FEW HOURS AFTER VACCINATION SHE HAD FEVER, CHILLS AND BODY ACHES. AFTER SLEEPING FOR A FEW HOURS SHE WOKE UP TO TERRIBLE TACHYCARDIA. SHE FELT THAT HER HEART WOULD STOP AND START BEATING ALL OVER AGAIN. SHE WAS VERY SCARED AND THOUGHT "SHE WAS GOING TO DIE" (VERBATIM).
60 2021-06-14 excessive bleeding, anaemia When she goes to the bathroom blood gushes out in clot/the blood just start gushing out; been bleedi... Read more
When she goes to the bathroom blood gushes out in clot/the blood just start gushing out; been bleeding since i got the shot/bleeding; felt like peeing and blood start pouring out/feeling like they are having a period for 3 days then stop then come back; got pain, had to sit down, like someone pulling your insides out pain was excruciating/pain/there is so much pain/pain everyday/pain like period or having a baby; egg like secretion down there; waking up soaking wet down there; pain in the belly; Leg gave out/feels like someone is pulling her bones apart down below/left leg felt like coming apart; anemic; bleeding every week for 2 to 7 days followed by white stuff and back to bleeding; Other staff is coming from my body/ feeling something travelling through my body; Blow up in leg; pain different from sciatica; afraid for my life; don't feel like I am going to live/feeling terrible; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (When she goes to the bathroom blood gushes out in clot/the blood just start gushing out) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included GABAPENTIN for Sciatica. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced ANXIETY (afraid for my life) and FEELING OF DESPAIR (don't feel like I am going to live/feeling terrible). On an unknown date, the patient experienced HAEMORRHAGE URINARY TRACT (When she goes to the bathroom blood gushes out in clot/the blood just start gushing out) (seriousness criterion medically significant), HAEMORRHAGE (been bleeding since i got the shot/bleeding), GENITAL HAEMORRHAGE (felt like peeing and blood start pouring out/feeling like they are having a period for 3 days then stop then come back), PAIN (got pain, had to sit down, like someone pulling your insides out pain was excruciating/pain/there is so much pain/pain everyday/pain like period or having a baby), GENITAL DISCHARGE (egg like secretion down there), HYPERHIDROSIS (waking up soaking wet down there), ABDOMINAL PAIN (pain in the belly), LIMB DISCOMFORT (Leg gave out/feels like someone is pulling her bones apart down below/left leg felt like coming apart), ANAEMIA (anemic), VAGINAL DISCHARGE (bleeding every week for 2 to 7 days followed by white stuff and back to bleeding), FEELING ABNORMAL (Other staff is coming from my body/ feeling something travelling through my body), PERIPHERAL SWELLING (Blow up in leg) and PAIN (pain different from sciatica). The patient was treated with GABAPENTIN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HAEMORRHAGE URINARY TRACT (When she goes to the bathroom blood gushes out in clot/the blood just start gushing out), HAEMORRHAGE (been bleeding since i got the shot/bleeding), GENITAL HAEMORRHAGE (felt like peeing and blood start pouring out/feeling like they are having a period for 3 days then stop then come back), PAIN (got pain, had to sit down, like someone pulling your insides out pain was excruciating/pain/there is so much pain/pain everyday/pain like period or having a baby), GENITAL DISCHARGE (egg like secretion down there), HYPERHIDROSIS (waking up soaking wet down there), ANXIETY (afraid for my life), FEELING OF DESPAIR (don't feel like I am going to live/feeling terrible), ABDOMINAL PAIN (pain in the belly), LIMB DISCOMFORT (Leg gave out/feels like someone is pulling her bones apart down below/left leg felt like coming apart), ANAEMIA (anemic), VAGINAL DISCHARGE (bleeding every week for 2 to 7 days followed by white stuff and back to bleeding), FEELING ABNORMAL (Other staff is coming from my body/ feeling something travelling through my body), PERIPHERAL SWELLING (Blow up in leg) and PAIN (pain different from sciatica) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Smear cervix: normal (normal) normal. Patient sought out help from Primary care, was referred to a OBGYN, got a pap smear normal and said that the HCPs did not provide information on what may be causing the symptoms. She received Gabapentin and Tylenol as treatment without symptoms' relief. Reporter provide additional phone number Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-163813 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: updated reporter information and new events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
60 2021-06-15 chest pain So I got my first vaccine on 12/20/2020 and got labs on 1/16/2021 which was part of a routine visit ... Read more
So I got my first vaccine on 12/20/2020 and got labs on 1/16/2021 which was part of a routine visit and they found those to be elevated so they said to repeat the labs and on the 30th I repeated my labs not thinking that the vaccine on the 21st would impact that but the results were even more elevated. On Feb 1st I had a phone visit with my PCP to review my results and then started seeing a gastroenterologist, I had a scope done. I went back to them on the 22nd of March for a follow up of elevated liver enzymes and EKG was on March 4th as well. On March 26th I went to my PCP for an enlarged corroded gland, they said it was an inflammatory response which was on my right side which is where I received my vaccine as well. On April 23rd they repeated labs, went back to gastroenterology on April 30th. In February I was also admitted for observation because of chest pain, that was on the 15th. They did a lexiscan and found the four areas of concern in my right lung. Then I had a CT scan on 2/19/2021 to follow up with that. Repeat CAT scan to follow up with nodules on 6/3/2021. So I am currently repeating labs and going back to the gastroenterology on the 29th of this month (June). I also have an appnt on July 17th to follow up with my Cardio.
60 2021-06-15 fibrin d dimer increased, pulmonary embolism Acute bilateral pulmonary emboli - onset of shortness of breath 1 day prior to diagnosis on 6/14/202... Read more
Acute bilateral pulmonary emboli - onset of shortness of breath 1 day prior to diagnosis on 6/14/2021
60 2021-06-16 chest pain I started with extreme fatigue and muscle pain the morning after my vaccine. It felt like all my mus... Read more
I started with extreme fatigue and muscle pain the morning after my vaccine. It felt like all my muscles were in constant spasms. I went to the DR and she started doing blood work immediately. There is a lot I don't remember due to memory problems, and I have had ongoing headaches as well. Eating was a problem, I couldn't eat, it just would not go down. My NP suggested hydrating liquids so I went straight to pedialyte and should've bought stock in the product I bought so much. One time I went to her office and I stayed there for about 3 hours because she was afraid to send me home and didn't want me to go to the hospital. She gave me a shot but I don't remember what it was, I just don't have much memory. The two weeks after the shot I was in a lot of pain, severe pain, I could barely walk. They stayed in constant spasms and just tightness. I was shaking, I don't even remember if I had a fever at all but it's possible. I do remember my NP talking about lactic acid in my blood being high, and she has all those blood results there. Potassium I think was low even though I take a supplement. At times my chest would hurt and the memory loss and fog was bad. I could not concentrate. I was lost for about 4 weeks, I still suffer from some muscle pain and fatigue. I work all week and come the weekend I now sleep like the whole weekend. I still have some muscle pain mostly in my legs. I still drink a l lot of water and I drink 2-3 32oz bottles a day and I drink Pedialyte still too. The DR also did an EKG with a heart rate of 30/35. I just feel like I will not get over this and never be 100% back. I can't even vacuum my house without getting warn out, whereas before the vaccine I could clean the whole house and be fine. That's all I can remember, you can probably get more from provider records.
60 2021-06-17 blood pressure increased swelling of throat, nausea, headache, increased blood pressure
60 2021-06-17 fast heart rate, blood pressure increased, hypertension Starting on the day of the vaccine 1st dose, just a sore arm. 3 days after the vaccine, I got dizz... Read more
Starting on the day of the vaccine 1st dose, just a sore arm. 3 days after the vaccine, I got dizzy, tachycardia and my blood pressure was very high around and starting racing. I was put on blood pressure medication metoprolol. I took the medication for a week and I now take it if needed. I have also noticed an adverse reaction after the vaccine everytime I drink or consume alcohol, I get elevated blood pressure, palpitation and sweats. I also had the same adverse reaction with the 2nd dose vaccine ( lot # 006M20A IM Right Arm).
60 2021-06-18 chest pain Chest pain lasting 4 days, treated with colchicine and ibuprofen and resolved within two days of tre... Read more
Chest pain lasting 4 days, treated with colchicine and ibuprofen and resolved within two days of treatment
60 2021-06-20 heart rate decreased, heart rate irregular, atrial fibrillation, heart rate increased, chest pain Immediately after the shot I felt fatigued for weeks and on Friday went into AFib and have been in t... Read more
Immediately after the shot I felt fatigued for weeks and on Friday went into AFib and have been in the hospital since with rapid irregular heart beat, extreme chest pain and fatigue. My heart rate will drop to 88/67 then jump to 157/100 it feels like my heart wanted to come out my chest. I was put on a blood thinner and I?m currently in the hospital being monitored waiting for more testing to be done .
60 2021-06-21 chest pain Pt was given her 2nd dose of COVID vaccine at 9:48 am. At 9:54 am pt was asked if she was feeling ok... Read more
Pt was given her 2nd dose of COVID vaccine at 9:48 am. At 9:54 am pt was asked if she was feeling okay and pt reported that she had "tingling in her throat". Assistance called for and vitals obtained(157/74) pulse rate 83, sat o2 100%. Pt reported chest pain to RN. RN reported clear breath sounds and no labored breathing. Dr. arrived besdie patient and pt was evaluated. At 10:02 am pts vital was (144/76) HR 76 and sat o2 on room air 100%. Dr. provided samples of Xyzal to patient. Patient was clear of hives and at 10:05 am pt was reporting that she was feeling better and had no chest pain. At that time pts vitals was (142/76) HR 74 with sats 99% on room air, respirations 18. 1017- BP-143/76, HR-73, Res-18, sats- 100% Patient alert and oriented at this time. No resp distress noted. Patient reports she is feeling better and denies any chest pain at this time. Will continue monitoring. 1029- BP-136/70, HR-68, Res-18, sats- 99% Patient continues to converse in casual conversation. No distress noted. Instructions provided for patient to call 911 if displays signs and symptoms of anaphylaxis reaction. Patient waiting for transportation (son). 1055- BP-156/73, HR-72, Res-18, sats- 100% Patient walked out of room to check out. No distress noted.
60 2021-06-21 palpitations Systemic: heart racing, daughter said she has had panic attacks recently and this looked like that-M... Read more
Systemic: heart racing, daughter said she has had panic attacks recently and this looked like that-Mild
60 2021-06-21 platelet count decreased, chest discomfort, chest pain, oxygen saturation decreased Kidney function and platelets low; Chest Pain; A Lot of coughing; Phlegm; Feeling that something is ... Read more
Kidney function and platelets low; Chest Pain; A Lot of coughing; Phlegm; Feeling that something is sitting on my chest; Shortness of breath; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RENAL IMPAIRMENT (Kidney function and platelets low) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history provided by the reporter. Concomitant products included LOSARTAN, ATORVASTATIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced CHEST PAIN (Chest Pain), COUGH (A Lot of coughing), PRODUCTIVE COUGH (Phlegm), CHEST DISCOMFORT (Feeling that something is sitting on my chest) and DYSPNOEA (Shortness of breath). On 27-May-2021, the patient experienced RENAL IMPAIRMENT (Kidney function and platelets low) (seriousness criterion medically significant). At the time of the report, RENAL IMPAIRMENT (Kidney function and platelets low), CHEST PAIN (Chest Pain), COUGH (A Lot of coughing), PRODUCTIVE COUGH (Phlegm), CHEST DISCOMFORT (Feeling that something is sitting on my chest) and DYSPNOEA (Shortness of breath) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Oxygen saturation decreased: low (Low) low. On 27-May-2021, Platelet count decreased: low (Low) low. On 27-May-2021, Renal function test: abnormal (abnormal) abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The labs include blood tests, chest scans, x-ray, CT scans, and echocardiogram whose results are not provided. Treatment information not given. The patient visited an urgent care, followed by Emergency department for the events and discharged on same day. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
60 2021-06-22 heart flutter Fluttery heartbeat, jittery Started around 30 minutes after the injection.
60 2021-06-22 fast heart rate Next day: tachycardia, short of breath, fatigue exerrtonal fatigue
60 2021-06-23 deep vein blood clot I received my first covid vaccine 03/18/2021 Lot #047A21A. After that vaccine I had headaches and a ... Read more
I received my first covid vaccine 03/18/2021 Lot #047A21A. After that vaccine I had headaches and a flushed face and was very tired. I an not a headache person so this is new to me. This continues. I received my second covid vaccine 04/19/2021. Since that vaccine, I have had continued headaches, am tired and have had brain fog. Trouble concentrating and focusing. I even had to see a neurologist. These symptoms continue as well. I was just diagnosed with a DVT 06/23/2021. This all is new to me and I believe are all related to my covid vaccines.
60 2021-06-23 heart rate increased, chest pain, inflammation of the heart muscle First dose Moderna received on 3/10. On 3/15 I started feeling sick. Extreme fatigue, chills and na... Read more
First dose Moderna received on 3/10. On 3/15 I started feeling sick. Extreme fatigue, chills and nausea. Over the next week my temperature was slightly elevated. 3/18 I went to clinic thinking this may be COVID. Both rapid and regular tests came back negative. The symptoms continued. In addition I notice my resting heart rate (while I was in bed) was over 100 when it is normally <65. (I am a runner and use a smart watch). I went to my GP on 3/23 and the nurse practitioner ordered tests. COVID was negative. C-Reactive Protein was 105. She sent me to the Cardiologist for suspected MyoCarditis. Cardiologist appt was 3/30/21. Dr. planned to send me for an Echocardiogram but before this (continued) was conducted, I started having chest pains and went to the emergency room. On 4/6-8/21 I was hospitalized. A multitude of tests were performed. Chest Xray, Chest CT, Echocardiogram, MRI (which revealed scarring on one of the lower sections of my heart confirming the MyoCarditis), Hearth Catheterization. I was discharged 4/8/21. I had a follow up Cardiologist Appt on 6/1/21. I am ok'd to slowly start exercising again. It has been hard to start running again so I am mostly walking 1-2 miles a day. (previously I was logging 20 - 25 miles a week). Question. My reaction was to the FIRST dose of Moderna. I have not received the second dose. Is there any data that shows the probability of a reaction to the second dose? I want to be protected, but in addition to possible health concerns, the costs incurred from the hospitalization are a financial burden.
60 2021-06-23 loss of consciousness Patient experienced light-headedness minutes after receiving the vaccine during her 15 minute observ... Read more
Patient experienced light-headedness minutes after receiving the vaccine during her 15 minute observation period - she briefly lost consciousness and fell out of her seat, striking her head on product shelving. She exhibited two minor lacerations approximately one inch long on her right arm and the right side of her face. She regained consciousness immediately and was fully aware of her surroundings. Patient received first aid treatment with antiseptic solution, antibiotic ointment, and bandages.
60 2021-06-27 chest discomfort On May 14th her bronchitis and asthma flared up. Had a tight chest and using her inhaler every four ... Read more
On May 14th her bronchitis and asthma flared up. Had a tight chest and using her inhaler every four hours. Couldn't sleep because she was coughing so much felt fatigue so much. After the second vaccination which was June 18th she went to see Dr. because the symptoms got worse and she didn't feel any better. Doctor prescribe azithromycin 250mg for five days and stated it help with the cough. Also prescribe dueler twice a day and a cough medicine benzoate 200mg three times a day. Have been using a vaporizer and a steam medication. She also got prescribed Mucinex 1200 ml 2 times a day.
60 2021-06-30 chest pain Woke up in morning to get ready for work. Went into the bathroom to urinate, had crushing chest pai... Read more
Woke up in morning to get ready for work. Went into the bathroom to urinate, had crushing chest pain, got back to bed. Subsided after after a couple minutes. Very scary, took my breath away. I cried and called into work to say I wouldn't be in. Called MD clinic when they opened and got seen. As an RN, I knew the serious nature of heat pain.
60 2021-06-30 chest pain The morning after the second dose my arm hurt, and the pain was across my chest. It is the arm I rec... Read more
The morning after the second dose my arm hurt, and the pain was across my chest. It is the arm I received my shot in. I took Advil and it improved. Over the next couple of months my shoulder got worse until I could barely dress myself. It is very painful to do some things and I have lost some range of motion. I can't raise my left arm up over my head. I have a mild ache when I am just working at my computer but when I try to put on my clothes or reach for something especially when reaching backward. I have consulted a doctor and I am scheduled to start physical therapy. I got a cortisone shot yesterday and it has not helped much. I was diagnosed with Adhesive Capsulitis. It has improved slightly recently but it has been twelve weeks. I still have trouble sleeping.
60 2021-07-02 loss of consciousness couldn't breath; head started spinning where she saw white spots; passed out in the kitchen chair wh... Read more
couldn't breath; head started spinning where she saw white spots; passed out in the kitchen chair where her eyes were wide open and her husband couldn't feel her breathing; Pasty and sweating; Patient was white; developed a growth in her right leg in the shin that was cancerous/developed another cancerous growth on right forearm; rash got redder on the stomach area/rash on stomach would not go away; couldn't hear; swelling; Very sore left arm/right arm hurt; could not get out of bed; redness; brain fog; Nauseated; Chills all day; Red bump on the corner of a tattoo on her thigh/tattoo on thigh became red around it; Dizzy; Out of breath; passed out; Felt tired all day/very tired; Hard to lift her arm; Felt like she was "punched in the arm"; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient had history of high cholesterol. Concurrent medical conditions included Drug allergy. Concomitant products included VITAMINS NOS for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 09-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift her arm; Felt like she was "punched in the arm"). On 10-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), DYSPNOEA (Out of breath), DIZZINESS (Dizzy) and FATIGUE (Felt tired all day/very tired). On 17-Feb-2021, the patient experienced ERYTHEMA (Red bump on the corner of a tattoo on her thigh/tattoo on thigh became red around it). On an unknown date, the patient experienced DEAFNESS (couldn't hear), SWELLING (swelling), PAIN IN EXTREMITY (Very sore left arm/right arm hurt), DYSPNOEA (couldn't breath), VERTIGO (head started spinning where she saw white spots), BREATH HOLDING (passed out in the kitchen chair where her eyes were wide open and her husband couldn't feel her breathing), HYPERHIDROSIS (Pasty and sweating), GENERAL PHYSICAL CONDITION ABNORMAL (Patient was white), NEOPLASM SKIN (developed a growth in her right leg in the shin that was cancerous/developed another cancerous growth on right forearm), RASH ERYTHEMATOUS (rash got redder on the stomach area/rash on stomach would not go away), MOBILITY DECREASED (could not get out of bed), ERYTHEMA (redness), FEELING ABNORMAL (brain fog), NAUSEA (Nauseated) and CHILLS (Chills all day). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; PARAFFIN (LUBRIDERM [PARAFFIN]) for Adverse event, at an unspecified dose and frequency and CORTISONE (topical) for Adverse event, at an unspecified dose and frequency. On 13-Feb-2021, LOSS OF CONSCIOUSNESS (passed out), DYSPNOEA (Out of breath), VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift her arm; Felt like she was "punched in the arm") and DIZZINESS (Dizzy) had resolved. At the time of the report, DEAFNESS (couldn't hear), SWELLING (swelling), PAIN IN EXTREMITY (Very sore left arm/right arm hurt), DYSPNOEA (couldn't breath), VERTIGO (head started spinning where she saw white spots), BREATH HOLDING (passed out in the kitchen chair where her eyes were wide open and her husband couldn't feel her breathing), HYPERHIDROSIS (Pasty and sweating), GENERAL PHYSICAL CONDITION ABNORMAL (Patient was white), NEOPLASM SKIN (developed a growth in her right leg in the shin that was cancerous/developed another cancerous growth on right forearm), RASH ERYTHEMATOUS (rash got redder on the stomach area/rash on stomach would not go away), MOBILITY DECREASED (could not get out of bed), ERYTHEMA (redness), FEELING ABNORMAL (brain fog), NAUSEA (Nauseated) and CHILLS (Chills all day) outcome was unknown and ERYTHEMA (Red bump on the corner of a tattoo on her thigh/tattoo on thigh became red around it) and FATIGUE (Felt tired all day/very tired) had resolved. Concomitant medication included unknown cholesterol medication. Treatment for the event included ice and orange juice. It was reported that the red bump went away on an unknown date. On an unknown date, blood pressure measurement was high; CT scan, blood work, and electrocardiogram were normal. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD21-035540, MOD-2021-021611 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Added lab data and new events. Case upgraded to serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
60 2021-07-05 hypertension Liver cancer after second dose 90 cist; Diabetes diagnosis/diabetic from a time that coincides whit ... Read more
Liver cancer after second dose 90 cist; Diabetes diagnosis/diabetic from a time that coincides whit the first shoot; High blood pressure (200); Lump Under Arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jun-2021 and was forwarded to Moderna on 26-Jun-2021. This spontaneous case was reported by a health care professional and describes the occurrence of HEPATIC CYST (Liver cancer after second dose 90 cist) and DIABETES MELLITUS (Diabetes diagnosis/diabetic from a time that coincides whit the first shoot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included HERBAL EXTRACT NOS, HOMEOPATHICS NOS (SIMILASAN), MONTELUKAST SODIUM (SINGULAIR), EPINEPHRINE and LORATADINE for Allergy, SALBUTAMOL (ALBUTEROL HFA) for Asthma, HYDROCHLOROTHIAZIDE for Blood pressure fluctuation, MULTIVITAMIN & MINERAL for an unknown indication. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced HEPATIC CYST (Liver cancer after second dose 90 cist) (seriousness criterion disability), DIABETES MELLITUS (Diabetes diagnosis/diabetic from a time that coincides whit the first shoot) (seriousness criterion medically significant), HYPERTENSION (High blood pressure (200)) and VACCINATION SITE LYMPHADENOPATHY (Lump Under Arm). At the time of the report, HEPATIC CYST (Liver cancer after second dose 90 cist), DIABETES MELLITUS (Diabetes diagnosis/diabetic from a time that coincides whit the first shoot), HYPERTENSION (High blood pressure (200)) and VACCINATION SITE LYMPHADENOPATHY (Lump Under Arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: abnormal (abnormal) Blood sugar was not under control.. On an unknown date, Blood pressure measurement: high- 200 (High) Blood pressure high. On an unknown date, Glycosylated haemoglobin: high (High) Diabetic. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication include CPAP machine used for Apnea. The treatment information was not provided. Action taken with mRNA-1273 in response to the events was not Applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-237510, MOD-2020-001691 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
60 2021-07-05 hypotension, loss of consciousness, fast heart rate diarrhea, fall due to loss of consciousness, closed head injury, tachycardia, hypotension, leg cramp... Read more
diarrhea, fall due to loss of consciousness, closed head injury, tachycardia, hypotension, leg cramps, low potassium
60 2021-07-05 loss of consciousness Prediabetic; Blackout; Foamy urine; Pain in feet; Lost Quality of sight; This spontaneous case was r... Read more
Prediabetic; Blackout; Foamy urine; Pain in feet; Lost Quality of sight; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DIABETES MELLITUS (Prediabetic) and LOSS OF CONSCIOUSNESS (Blackout) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included HERBAL EXTRACT NOS, HOMEOPATHICS NOS (SIMILASAN), MONTELUKAST SODIUM (SINGULAIR), EPINEPHRINE and LORATADINE for Allergy, ALBUTEROL [SALBUTAMOL] for Asthma, HYDROCHLOROTHIAZIDE for Blood pressure fluctuation, MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Dec-2020, the patient experienced URINE ABNORMALITY (Foamy urine), PAIN IN EXTREMITY (Pain in feet) and VISUAL IMPAIRMENT (Lost Quality of sight). On an unknown date, the patient experienced DIABETES MELLITUS (Prediabetic) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (Blackout) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS (Prediabetic), LOSS OF CONSCIOUSNESS (Blackout), URINE ABNORMALITY (Foamy urine), PAIN IN EXTREMITY (Pain in feet) and VISUAL IMPAIRMENT (Lost Quality of sight) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications were reported were aolrapadine Allergy and Cpap Machine for apnea. The treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested This case was linked to MOD-2021-237497 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
60 2021-07-06 blood pressure increased, heart rate increased Sweaty; tongue feel raw and sore; feels feverish; Anaphylactic reaction; Heart rate more than 100 be... Read more
Sweaty; tongue feel raw and sore; feels feverish; Anaphylactic reaction; Heart rate more than 100 beats per min; Blood pressure which was 188/143.; Systolic blood pressure <90 mmHg; throat started to swell; Abdominal cramping; Feeling hot; her face became red and than blue; Started to gag/gagging sensation; Flushing; nausea; tongue felt huge; couldn't breathe; Mouth pain; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: DIPHTHERIA TETANUS PERTUSSIS VACCINE on 29-Jan-2021. Concurrent medical conditions included Sulfonamide allergy (FACE SWELLING HALF OF TONGUE SWELLED WHEEZING HARD TIME BREATHING) since 2016 and Blood pressure high on 30-Jun-2020. Concomitant products included LISINOPRIL from 30-Jun-2021 to an unknown date for Blood pressure, ATORVASTATIN from 01-Feb-2021 to an unknown date for Cholesterol, GABAPENTIN from 04-Feb-2021 to an unknown date for Nerve pain, DULOXETINE, MELOXICAM and VITAMIN D NOS for an unknown indication. On 22-Apr-2021 at 2:22 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced HEART RATE INCREASED (Heart rate more than 100 beats per min), BLOOD PRESSURE INCREASED (Blood pressure which was 188/143.), BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg), PHARYNGEAL SWELLING (throat started to swell), ABDOMINAL PAIN (Abdominal cramping), FEELING HOT (Feeling hot), ERYTHEMA (her face became red and than blue), RETCHING (Started to gag/gagging sensation), FLUSHING (Flushing), TONGUE DISORDER (tongue felt huge), DYSPNOEA (couldn't breathe), ORAL PAIN (Mouth pain), VOMITING (vomiting) and NAUSEA (nausea). On 20-May-2021 at 5:00 PM, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). On 21-May-2021, the patient experienced HYPERHIDROSIS (Sweaty), GLOSSODYNIA (tongue feel raw and sore) and PYREXIA (feels feverish). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) at an unspecified dose and frequency; ALUMINIUM HYDROXIDE, DIMETICONE, MAGNESIUM HYDROXIDE (ANTACID [ALUMINIUM HYDROXIDE;DIMETICONE;MAGNESIUM HYDROXIDE]) at an unspecified dose and frequency and DULOXETINE HYDROCHLORIDE (CYMBALTA) ongoing from 29-Jan-2021 for Pain, at a dose of 60 mg twice a day. On 20-May-2021, BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg) had resolved. On 20-May-2021 at 8:00 PM, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved. On 21-May-2021, GLOSSODYNIA (tongue feel raw and sore) and ORAL PAIN (Mouth pain) had resolved with sequelae. At the time of the report, HEART RATE INCREASED (Heart rate more than 100 beats per min), BLOOD PRESSURE INCREASED (Blood pressure which was 188/143.), PHARYNGEAL SWELLING (throat started to swell), ABDOMINAL PAIN (Abdominal cramping), FEELING HOT (Feeling hot), FLUSHING (Flushing), DYSPNOEA (couldn't breathe), VOMITING (vomiting) and NAUSEA (nausea) had resolved and ERYTHEMA (her face became red and than blue), RETCHING (Started to gag/gagging sensation), TONGUE DISORDER (tongue felt huge), HYPERHIDROSIS (Sweaty) and PYREXIA (feels feverish) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Blood pressure measurement: 188/143 (High) high. On 20-May-2021, Blood pressure systolic: less than 90 mmhg (abnormal) abnormal. On 20-May-2021, Heart rate: 100 breaths per minute (High) high. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (Anaphylactic reaction) to be possibly related. No further causality assessments were provided for HEART RATE INCREASED (Heart rate more than 100 beats per min), BLOOD PRESSURE INCREASED (Blood pressure which was 188/143.), BLOOD PRESSURE SYSTOLIC DECREASED (Systolic blood pressure <90 mmHg), PHARYNGEAL SWELLING (throat started to swell), ABDOMINAL PAIN (Abdominal cramping), FEELING HOT (Feeling hot), ERYTHEMA (her face became red and than blue), RETCHING (Started to gag/gagging sensation), FLUSHING (Flushing), TONGUE DISORDER (tongue felt huge), HYPERHIDROSIS (Sweaty), GLOSSODYNIA (tongue feel raw and sore), DYSPNOEA (couldn't breathe), ORAL PAIN (Mouth pain), VOMITING (vomiting), PYREXIA (feels feverish) and NAUSEA (nausea). It was reported that patient called in after receiving her 2nd dose of the Moderna covid vaccine on 20-May-2021. After receiving her vaccine approximately within 2 minutes, she started to gag, throat started to swell, and she was told by the staff members that her face became red and than blue. The pharmacist immediately administered an epi-pen and she slowly was able to stop gagging. The pharmacy dialed 9-1-1 and the EMS came. They took her blood pressure which was 188/143. They took her to the hospital and about 10 minutes in the ambulance she experienced the gagging sensation and her tongue felt huge. They administered the epi-pen again along with Benadryl and an antacid. She was monitored at the hospital for four hours and discharged. While at the hospital she had the gagging experience again and tongue felt huge. They administered the epi-pen again and she remained on IV which she believes contained Benadryl and an antacid. She is contacting the hospital to find out exactly what she was prescribed there. Today, 21may2021 she has to clear her throat a lot, feels feverish, sweaty, tongue feel raw and sore. She is highly allergic to sulfa. She wanted to know if these symptoms have been reported before and if the medications, she was administered at the hospital are going to effect the vaccine efficiency. She was wondering if Moderna could provide any compensation for her medical costs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up information received on 24-Jun-2021 and included New reporter details were added, Suspect vaccine dosing details were updated, Patient demographics (race) was updated, new medical history was added, concomitant drugs indications, dosing and start dates were added, new concomitant drug Cymbalta was added, New historical vaccine was added, New serious event anaphylactic event was added, New non serious events were added, New lab tests were added. Suspect vaccine Batch number was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
60 2021-07-06 platelet count decreased Three to fours after the injection, my body started to ache and I started feeling weak. It reminded ... Read more
Three to fours after the injection, my body started to ache and I started feeling weak. It reminded me of the flu, I was not nauseous. Once I got home and ate and was in bed, I took 2 extra strength Tylenol. I slept it off and felt fine the next day. Since the injection I have had strange health issues going on, I am not sure if they are related to the vaccine or my underlying health issues. The major issue being blood platelet count. About a month and a half ago, I felt extremely tired out of nowhere. I could not get out of bed. I did not feel sick, just exhausted. It was about two weeks after that, my doctor told me my platelet count was low and that could be why I felt the way I did. My doctor ordered a second blood test.
60 2021-07-07 palpitations Patient was felling anxious; heart was racing, and she felt dizzy. She said her throat felt tight, b... Read more
Patient was felling anxious; heart was racing, and she felt dizzy. She said her throat felt tight, but she has Eagle syndrome that causes this normally. She felt it was her syndrome was causing the symptoms, but we proceeded with caution. I administered 50mg (20ml) of oral diphenhydramine. She declined laying down but advised her to put her head between her legs for the dizziness. She stated she was better and calmer. After approximately 10 minutes she said her throat was returning to normal and she was able to calm down. After the full 30-minute wait she stated she was fine, her throat was how it was before she got her shot, and her dizziness was better, and she felt safe to leave with her husband. I advised her to take diphenhydramine in 4-6 hours if needed and not to hesitate to call 911 if her symptoms worsen at home.
60 2021-07-08 chest pain, troponin increased, heart attack Seen at hospital for chest pain and shortness of breath on 4/07/2021. Found to have NSTEMI
60 2021-07-08 chest pain About 12:30pm on the 4/26 I was feeling nauseous and my energy level went from a ten down to a three... Read more
About 12:30pm on the 4/26 I was feeling nauseous and my energy level went from a ten down to a three. By 06:00-07:00pm my head and chest were hurting and my arm felt like it was going to fall off. I could not lift my head from my pillow. The symptoms the first 3 days were very severe. On 4/29 my primary physician did a telephone call with me, they told me I may have the flu. The physician called me back and told me to go get a COVID 19 test done. The doctors were calling and checking in on me. My COVID test results were negative. I had a chest xray. By the 7th day I started to feel a little better. By the 10th day I was able to eat soup. My arm pain lasted for 20 days after my vaccine. My feet and ankles are swollen to this day.
60 2021-07-11 oxygen saturation decreased Patient received Moderna COVID vaccine on 3/27/21 and 4/24/21. Patient states that she had a large g... Read more
Patient received Moderna COVID vaccine on 3/27/21 and 4/24/21. Patient states that she had a large gathering of family and friends on 7/4/21. Since then some people at the gathering had developed mild fevers and cough. Most however doing fine and have no acute symptoms. Patient however states that beginning 7/10/21, she began to have horrible asthma exacerbation, patient on prednisone 10 mg daily at this time but states she took 40 mg of prednisone secondary to concern for asthma exacerbation. On 7/11/21, patient again took 40 mg of prednisone, multiple rounds of her beta agonist without symptom relief. Patient noted that her home oxygen saturations on home pulse oximeter 85%. Patient is brought to ED for evaluation and eventually admitted. On 7/12/21, patient had respiratory decompensation failing HFNC and BiPAP, O2 desaturation in the 60's, and was extremely short of breath. FiO2 was increased to 100% without recovery. Patient was intubated and transferred to CCU on 7/12/21. This event is being reported due to COVID cases resulting in hospitalization even though patient was fully vaccinated.
60 2021-07-20 heart rate increased Woke up with dry heaves vomiting . Fever of 102 for 24 hours. Rapid heartbeat that was too high ... Read more
Woke up with dry heaves vomiting . Fever of 102 for 24 hours. Rapid heartbeat that was too high to register on home device, chills , body aches , fatigue . Heartbeat settled down around 1100 p.m. Next day low grade fever of 100 and chills continue. Fatigue lasted for several days. Better now but occasionally get unusually tired but then I am 61 now.
60 2021-07-20 pallor, loss of consciousness, blood pressure decreased I felt a sore arm for the first few days and a little nauseous but it was minor and I was able to co... Read more
I felt a sore arm for the first few days and a little nauseous but it was minor and I was able to continue working from home no problem. I felt fine when I went to bed Thursday (3 days after the vaccine) night but was awakened suddenly feeling very ill at 3am. I went to the bathroom and my face was void of color as were my lips. I then dropped to the floor as I was passing out. It was a very scary unnatural feeling. I think I passed out but I don't remember because then suddenly I was vomiting and had diarrhea. The whole episode came on suddenly (awakening me from a sound sleep) and ended about 2 hours later. I felt exhausted and nauseous for a few hours after but nothing further. It was a sudden drop in my blood pressure that was so frightening and I thought important to report. I've never had the experience before or since.
60 2021-07-22 hypertension Extreme Headache after Second Dose; Extreme High Blood Pressure after Second Dose; This spontaneous ... Read more
Extreme Headache after Second Dose; Extreme High Blood Pressure after Second Dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Extreme Headache after Second Dose) and HYPERTENSION (Extreme High Blood Pressure after Second Dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (Extreme Headache after Second Dose) (seriousness criterion hospitalization) and HYPERTENSION (Extreme High Blood Pressure after Second Dose) (seriousness criterion hospitalization). At the time of the report, HEADACHE (Extreme Headache after Second Dose) and HYPERTENSION (Extreme High Blood Pressure after Second Dose) outcome was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
60 2021-07-24 heart failure Cardiomyopathy (HART FAILURE)
60 2021-07-25 blood pressure increased Headache, elevated blood pressure since vaccone, dizzy feeling since
60 2021-07-25 blood clot 3 days after second vaccine. Surface veins right leg midthigh to midcalf enlarged. Doppler US showed... Read more
3 days after second vaccine. Surface veins right leg midthigh to midcalf enlarged. Doppler US showed multiple clots.
60 2021-07-27 heart rate increased, blood pressure increased Headache, fatigue, high heart rate, high blood pressure (as high as 180/90)
60 2021-07-28 blood pressure increased, heart rate increased exacerbation of Celiac disease; Bubble floating in eye/eyes had a bubble floating there for a week; ... Read more
exacerbation of Celiac disease; Bubble floating in eye/eyes had a bubble floating there for a week; Difficulty focusing eye; Elevation of blood pressure; Stomach Pain/severe stomach pain for about 3 weeks; Lying in bed for 3 days; Difficult to breathe; Extremely scary heartbeat at night while sleeping; This spontaneous case was reported by a consumer and describes the occurrence of COELIAC DISEASE (exacerbation of Celiac disease) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Celiac disease (worsening symptoms) since 1995. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEART RATE INCREASED (Extremely scary heartbeat at night while sleeping). On an unknown date, the patient experienced COELIAC DISEASE (exacerbation of Celiac disease) (seriousness criterion medically significant), VITREOUS FLOATERS (Bubble floating in eye/eyes had a bubble floating there for a week), VISION BLURRED (Difficulty focusing eye), BLOOD PRESSURE INCREASED (Elevation of blood pressure), ABDOMINAL PAIN UPPER (Stomach Pain/severe stomach pain for about 3 weeks), BED REST (Lying in bed for 3 days) and DYSPNOEA (Difficult to breathe). On 20-Feb-2021, VITREOUS FLOATERS (Bubble floating in eye/eyes had a bubble floating there for a week), VISION BLURRED (Difficulty focusing eye) and HEART RATE INCREASED (Extremely scary heartbeat at night while sleeping) had resolved. At the time of the report, COELIAC DISEASE (exacerbation of Celiac disease) and BLOOD PRESSURE INCREASED (Elevation of blood pressure) outcome was unknown and ABDOMINAL PAIN UPPER (Stomach Pain/severe stomach pain for about 3 weeks), BED REST (Lying in bed for 3 days) and DYSPNOEA (Difficult to breathe) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Heart rate: rapid (High) rapid. On 19-Feb-2021, Heart rate: rapid (High) rapid. In 2021, Blood pressure measurement: elevated (High) elevated. Concomitant product use was not provided by the reporter. The patient had severe stomach pain for about 3 weeks after the vaccine, extremely scary heartbeat at night while sleeping. It woke her up because it was difficult to breathe. It settled within a few minutes both times but was very disturbing. One of the eyes had a bubble floating there for a week and she had difficulty focusing it. The patient went to see doctors for all of these. Eventually they resolved themselves, but the fear of breathing issues at night remained. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-jun-2021. No new information. On 23-Jul-2021: Significant Follow up received on 23Jul2021 contains events updated breathing difficult and Difficulty focusing eyes and fear of breathing issues at night relevant history celiac as current condition and suspect dose date detail.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
60 2021-07-28 loss of consciousness been sick since I recieved the 1st dose nausa, worst migranes, blacking out, have more sick days the... Read more
been sick since I recieved the 1st dose nausa, worst migranes, blacking out, have more sick days then not
61 2021-01-05 palpitations, chest discomfort Within 5 minutes felt warm sensation over body, felt lump in throat , then chest tightness with palp... Read more
Within 5 minutes felt warm sensation over body, felt lump in throat , then chest tightness with palpitations.
61 2021-01-05 palpitations Headache, fever, shaking, nausea, diahhrea, body aches, dizziness, cough and heart racing. This las... Read more
Headache, fever, shaking, nausea, diahhrea, body aches, dizziness, cough and heart racing. This last for about 48 hours. This is day7 and I still nausea and no energy.
61 2021-01-05 lightheadedness Diarrhea, near syncope, extreme fatigue. Started 30 hours post injection & continued x 48 hours. S... Read more
Diarrhea, near syncope, extreme fatigue. Started 30 hours post injection & continued x 48 hours. Site soreness/edema 24 hours after injection that increased to extreme sensitivity at site after 30 hours which lasted 24 hours. Left deltoid swollen x 1/2 more than usual size started 36 hours after injection and lasted 36 hours.
61 2021-01-06 pallor 6-8 minutes after the shot felt a sensation from left shoulder slowly sweeping across body, going in... Read more
6-8 minutes after the shot felt a sensation from left shoulder slowly sweeping across body, going into face and neck to the inside of left eye. Face had a weird feeling also. Headache, tonged tingling. Left and went to the car. Face was red and swollen all over. Skin looked like she was skiing in the middle of winter. She went back inside the hospital to her department on the 5th floor and stayed about 30 minutes. Then she went home. Half bottom lip was swollen, Both eyes got itchy, glassy, watery. Behind sinuses hurt really bad. Next day pain in hips both knees. Took 2 full days for the redness to go away from face. Had dark circles under eyes. Took Claritin. Hair has been shedding, sever brain fog at work. Her employer told her to take some time off from work . Upper teeth hurt.
61 2021-01-07 palpitations 25 minutes after shot started having tightness in my throat, then heart pounding. Pulled into ER on ... Read more
25 minutes after shot started having tightness in my throat, then heart pounding. Pulled into ER on my drive home. Received medications, prednisone, benadryl and pepcid and was observed a few hours. Ok now. Still glad I got vaccine since I am in health care.
61 2021-01-07 palpitations Palpitations - Heartrate 118
61 2021-01-07 fast heart rate Tachycardic, HR to 108, BP 152/72, improved over 5 minutes sitting
61 2021-01-08 blood pressure increased, heart rate increased started with metallic taste in mouth, progressed rapidly to clammy, light headed, elevated BP and HR... Read more
started with metallic taste in mouth, progressed rapidly to clammy, light headed, elevated BP and HR. All of these progressed within minutes starting at 8:20 AM. Treated by drinking water, relaxation breathing, sitting for a half hour. Left the facility at approx 9:15 AM, but stayed close as requested and was told not to drive as still not feeling right, but better. As the day progressed, developed chills, fatigue, nausea, some shortness of breath, mild exacerbation of asthma- cough, then mild fever, runny nose, severe pain left arm. Symptoms finally moderated to just fatigue and body aches by the evening. Took 2 puff sof albuterol inhaler and 2 advil in the afternoon. Woke the next day with left arm pain, fatigue and continued to treat with advil through the day. Woke today, Jan 9 feeling normal. I did decline suggestion of going to the ER or my PCP when BP remained elevated at 11:30 AM on date of vaccination, chose to go home to self monitor.
61 2021-01-09 blood glucose increased I was injected in the right arm with Moderna COVID-19 Vaccine EUA 0n 1/8/2021, 9:57 am at Clinic. I... Read more
I was injected in the right arm with Moderna COVID-19 Vaccine EUA 0n 1/8/2021, 9:57 am at Clinic. I waited 15 minutes before I left the facility and okay. Did move my right arm so not to be sore. Worked regular shift: 4 pm to 10 pm and started to feel cramping. at 11:25pm, began to chill and body aches, took 2 Tylenol tablets for pain. did glucose injections : humalog: 38 units and Toujeo 54 units ( glucose was 257). Regular medications: Lisinopril 40 mg, Atorvastatin 40 mg, metoprolol 25 mg, Spironolactone 25 mg and Meloxicam 7.5 mg. Went to bed at 11:45 pm, with 3 extra blankets and winter pajamas. Woke at 1:30 am with hot flash (thinking fever) Could not find Thermometer, still had aches and pains, nausea, headache and fatigue. Contacted staff on call and replacement for Saturday shift. Went to 24 hour pharmacy and purchased a digital thermometer. I did have elevated temperature. I usually rate normal temperature of 96 to 97.7 and temperature was at 99 when taken at 3 am in the morning. Temperature remained below 99 when taken on Saturday. Rested and ate properly, maintained good glucose readings. Returned to work on Sunday morning.
61 2021-01-09 palpitations Thursday and Friday night i had heart palpitations. Thursday night I had body aches all over and ni... Read more
Thursday and Friday night i had heart palpitations. Thursday night I had body aches all over and night sweats. Also night sweats Friday and Saturday night. Friday I broke out in a rash on the insides of both thighs and under my arm pits.
61 2021-01-10 chest discomfort Waited at the vaccine location 30 minutes and felt fine, driving home started to feel tingling and n... Read more
Waited at the vaccine location 30 minutes and felt fine, driving home started to feel tingling and numbness on lips, face, face was puffy, mouth was dry, hard to swallow. Went to Medical Center as it was closest to home. This was about 1 hour after the shot was received. My chest was feeling tight when I arrived at the hospital and started with a slight headache.They checked my vitals BP was 146/91, pulse was 107, SPO2 was 98, temperature was 97.9. They gave me 2 Benadryl pills and had me stay in a room. After a few hours my vitals returned to normal and I was feeling better. They kept me a few more hours to make sure the symptoms did not return. I was discharged with a prescription for benadryl and zyrtec to take as needed. Only took the Benadryl that evening and the next morning with Tylenol. My arm was sore the next day but felt fine.
61 2021-01-10 loss of consciousness Extremely tired went to bed at 8:30. At 11:00, tossed and turned until 12:16 a.m. Did not think she ... Read more
Extremely tired went to bed at 8:30. At 11:00, tossed and turned until 12:16 a.m. Did not think she could stand up. Walked in the bathroom had pain in stomach, was very hot and freezing at the same time, was shaking. Head hurt was hurting so bad. Tried standing up from toilet, was passed out. Eye, half of face is bruised and swollen , eye shut for two days. More than forty minutes passed before she could call her husband. Does not remember anything because she was passed out. Husband came in and grabbed her, to get her back into bed. she could not stand. Went to ER at Hospital. Had CT scan, blood work , EKG, chest xray. Was still kind of out of it but was able to communicate with nurses. Face is still black and blue. Last night got up at 4:00 a.m. something was wrong with her throat. Felt like a walnut was in her throat. Went to doctor this morning. They said it was a reaction from the shot. Got an EpiPen, prednisone. Call them in 2 days to let them know how she's doing and also wear a heart monitor because they do not know how to take care of her, Has had vision blurriness in both eyes. Has not felt well at all.
61 2021-01-10 platelet count decreased one hour after vaccination patient noticed significantly swollen, tight, painful, and red bilateral ... Read more
one hour after vaccination patient noticed significantly swollen, tight, painful, and red bilateral ankles had been walking a lot, helping with mass vaccination clinic she reported her symptoms to the urgent care on site improved with elevation and Benadryl 50mg po, but symptoms persited for 48 hours
61 2021-01-10 fainting Headache , Fever 102, Nausea, Faint, Body/Muscle aches (lasted for 2 days)
61 2021-01-10 fast heart rate, palpitations Palpitations & Tachycardia Narrative:
61 2021-01-11 chest pain Severe stomach pain, no nausea, pain like a severe side ache; severe chest pain; headache. Chest p... Read more
Severe stomach pain, no nausea, pain like a severe side ache; severe chest pain; headache. Chest pain, left sided stomach pain, and headache persisted through the night. I was able to get some relief by takin a 325 mg Aspirin and an Advil every 2-3 hours through the night. The chest pain was pretty bad, considered going to the ER, but persisted to fight it through to the morning. In the morning, around 6:30 am I was exhausted, but the worst of the pain was over. I did take another Aspirin and Advil around 8:00 am and stopped after that. I did run a low grade fever off and on of 99.7 to 100.4. I felt better on Saturday, but by noon I was feeling generally run down and again started to run a low grade fever off an on the rest of the day. Sunday - what a joy to feel totally well!!
61 2021-01-11 hypotension At 7:00pm felt like I would faint & nauseated. Blood pressure 96/57. Laid down & drank a ton of fl... Read more
At 7:00pm felt like I would faint & nauseated. Blood pressure 96/57. Laid down & drank a ton of fluids. Bp came up after 45 min. Felt extremely nauseated, dizzy, sick, nose ran constantly, weak, lethargic, shaking chills for 4 hours. During that time, continued to feel faint, chills, weak & very nauseated. Extremely restless. Temp with ear thermometer was 98.4. Never vomited. Around 11 pm I began feeling better.
61 2021-01-12 ischemic chest pain, palpitations Angina, palpitations and right arm numbness. Pt stated feeling was coming back.
61 2021-01-12 blood pressure increased Patient arrived at drive thru clinic, received injection along with other co-workers, she pulled to ... Read more
Patient arrived at drive thru clinic, received injection along with other co-workers, she pulled to our waiting area where a emergency squad had been, a coworker acknowledged that she was having difficulty breathing, patient states they (squad) wanted to bring her to the hospital and that she refused, she was fine, again they asked her multiple times and she did not want to go to the local hospital here. she stated that she drove herself to her local ED and was taken care of there. Patient states that they gave her a nebulizer treatment and advised her to continue to get the series of shots and to make sure she has her inhaler with her the next time. Patient did report that when she left the hospital that her BP was 179/99 and the doctor advised her that it would go down, she stated it did return to normal that night as she has a bp cuff at home and she took it several times. Patient stated that doctor told her that she had a histamine reaction to the vaccine and he has seen this several times this week.
61 2021-01-12 chest discomfort Chest tightness and throat tightness 1 hour following vaccination along with itching and rash at inj... Read more
Chest tightness and throat tightness 1 hour following vaccination along with itching and rash at injections site. Zyrtec was taken along with use of Albuterol inhaler.
61 2021-01-12 hypertension Patient stated that she went to the observation area and started to have difficulty breathing, the e... Read more
Patient stated that she went to the observation area and started to have difficulty breathing, the emergency squad went to the patient and advised her to get out of car and go into the squad to get evaluated and the patient refused because did not want to go to the local hospital here. They observed the patient for 30 more minutes and determined that she needed her inhaler. but, she had forgotten it they advised again to go to hospital and patient refused. she stated that she was fine and decided to drive to the hospital in her home town. when she arrived they gave her a nebulizer treatment as she had wheezing and high blood pressure when arrived at hospital. The patient stated that the physician told her that she was fine and that she just had a histamine reaction. He stated that the blood pressure that was 179/99 prior to her leaving would go down as she was not relaxed and over excited. Patient stated that she did take her blood pressure when she got home and it was normal. and she felt better. she stated that if she was by herself that day, she would have never reported it, because she has had worst Asthma attack's In the past. The patient also stated that her doctor advised her to get the second shot in the series and to make sure she carries her inhaler with her when she goes.
61 2021-01-12 palpitations Patient was vaccinated at our hospital clinic, and went into the waiting room area for the 15 minute... Read more
Patient was vaccinated at our hospital clinic, and went into the waiting room area for the 15 minute observation. After about 10 minutes she laid on the floor and said she was dizzy and her heart was racing. She never left consciousness. Observers went over to her and took her pulse and B/P. She stood up and get into a wheelchair and they took her to ED. Once in the ED the symptoms were resolved according the physician record. Today, January 13th, she is back at the ED with complaints of arm soreness and heart racing. She is currently in the ED and her disposition is unknown at this time.
61 2021-01-13 blood pressure increased 10 minutes after getting vaccination my left arm tingling and then started going numb and then my ha... Read more
10 minutes after getting vaccination my left arm tingling and then started going numb and then my hand started stiffinging. I was dizzy and my Bp went up to 144/100. it spiked to 168/107. EMs was called and they completed and EKG and monitoired my bp until it came down. I did not go to the ED
61 2021-01-16 heart rate increased Pt stated she became dizzy, and sweaty with fast heartrate.
61 2021-01-17 atrial fibrillation new onset rapid Afib converted with diltiazem, elevated BP-continues
61 2021-01-17 palpitations Patient because flush and hives appeared on chest and face. Patient reported palpatations. Denied ... Read more
Patient because flush and hives appeared on chest and face. Patient reported palpatations. Denied respiratory distress. Diphenhydramine and EpiPen given. Patient taken to the ED and was improving when she arrived. Monitored in the ED with continuous BP, pulse ox and cardiac monitoring.
61 2021-01-17 fainting 61 y.o. female who arrived by Home presented to the emergency department for Evaluation of syncopal ... Read more
61 y.o. female who arrived by Home presented to the emergency department for Evaluation of syncopal episode. Patient reports earlier this morning at 330 she awoke to go get a glass of water, states that she felt significantly weak and felt that she would drop the glass of water she was going to get it. She describes mild associated lightheadedness but denies vertigo, visual disturbance, chest pain, dyspnea. She that went to ambulate to the living room so she lied on the couch, but does not exactly remember what happened after this. She remembers that there is a chair and she thinks she may have fallen forward and hit her head against a chair and fell down to the ground. She notes that she had currently has a fat lip and feels slight abrasions on her knees bilaterally. History is notable for hypertension, dyslipidemia, states has been compliant with her medications. No recent illnesses, cough, colds. She underwent vaccination 3 days ago for COVID with the majority of vaccine and reported 2 days ago she had mild body aches and myalgias, however at present states she feels largely asymptomatic. She was encouraged to present to the emergency department at the request of her coworkers Laboratory work-up largely unremarkable. CT head no acute process. EKG my read sinus rhythm, normal PR, QRS, QTc, no ST segment changes or T wave inversions concerning for ischemia. Discussed the work with the patient recommended that she follow-up as an outpatient with her primary care provider, also provided with a Zio patch and recommend to follow-up with cardiology. Patient extravascular fat study with plan felt comfortable for discharge home. Discharged in stable condition
61 2021-01-18 arrhythmia 1/4/21(day of vaccine)-approximately 1 hour later, irregular heart beats, "skipped beats" approximat... Read more
1/4/21(day of vaccine)-approximately 1 hour later, irregular heart beats, "skipped beats" approximately every 10 seconds, decreasing in frequency over the next few hours, but persisting 2 weeks later. Appointment scheduled tomorrow ((1/20/21) with cardiologist. 1/11/21 (day 7 post vaccine)-vaccine site began to itch and induration began 1/12/21 (day 8 post vaccine)-marked induration, well demarcated redness, warmth and mild tenderness around vaccine site, measuring 8.5 cm x 5.5 cm. Rx with advil 400 mg and icepacks which help, but local reaction persisted approximately 5 days 1/14/21(day 10 post vaccine)-site still red and swollen, but starting to fade. Sneezing and rhinitis begins in PM 1/15/21 (day 11-continued..
61 2021-01-18 heart rate increased Vaccine at 0900; itchy eyes by 0950; lips swelling than face. Got hives on face and rest of body itc... Read more
Vaccine at 0900; itchy eyes by 0950; lips swelling than face. Got hives on face and rest of body itchy. Took 25 mg Benadryl at 1015. By 1130 hives were gone but itching continued. Used eye allergy relief. Lips swollen for 24 hours. No shortness of breath. At 2100 got rapid heart rate till about 2130. Resolved. Continued having itchy skin and eyes for 4 days. On 01/14/2021 started fexofenadine 180 mg one per day and used eye drops as needed for itchy eyes
61 2021-01-19 palpitations Fatigue, heart palpitations, weakness in the legs, dizziness when standing/walking, & mild sweating ... Read more
Fatigue, heart palpitations, weakness in the legs, dizziness when standing/walking, & mild sweating at times. Duration has been since the shot. FYI: I was experience stress and lethargy prior to getting vaccine. I got a Covid-19 test on 1/14/20 suspecting possible Covid-19. The test was Negative. After receiving the vaccination, the symptoms I was experiencing previously worsened.
61 2021-01-19 palpitations Trouble breathing; Nauseated; Heart Palpitations; Hot, felt flush; A spontaneous report was received... Read more
Trouble breathing; Nauseated; Heart Palpitations; Hot, felt flush; A spontaneous report was received from a nurse concerning a 61 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, hot, felt flushed, heart palpitations, nauseated and trouble breathing. The patient's medical history, as provided by the reporter, included myocardial infarction. Concomitant medications reported included sertraline hydrochloride. On 30 Dec 2020, approximately 20 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 30 Dec 2020, the patient was walked to the waiting room to wait 15-20 minutes following vaccination. At 3:50 pm the patient began to feel hot and flushed. The patient started having heart palpitations and felt nauseated. The patient was assisted by a nurse and approximately 20 minutes later, patient reported feeling better. The patient was instructed to wait another 30 minutes before leaving the clinic. At 4:30 pm, the patient stated that she was not feeling well, reporting heart palpitations, flushing and trouble breathing. Patient was taken to the hospital via emergency medical services at 4:43pm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, hot, felt flushed, heart palpitations, nauseated, and trouble breathing, was unknown..; Reporter's Comments: This case concerns a 61 year old, female patient, with medical history of Myocardial Infarction, who experienced a serious, unexpected events of hot flush, heart palpitations, nausea and trouble breathing. The event occurred 20 minutes after administration of the first dose of mRNA-1273 (Lot number: 011J20A). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of mRNA-1273 and the onset of the event, a causal relationship cannot be excluded.
61 2021-01-20 blood pressure increased, hypertension No problems after vaccine given - 12 hours post vaccine awoke with BP high , symptoms of high BP and... Read more
No problems after vaccine given - 12 hours post vaccine awoke with BP high , symptoms of high BP and achy back/neck - Took extra Metoprolol stayed up 1 hour - fell asleep and slept until noon next day - Felt better and was fine until (one week later) 1/20/21 Same symptoms as before (like coming down with the flu) and spiked BP - took extra BP med, but BP still high. Noticed my Arm aching where the vaccine was given and now (was not there after injection) red patch over where vaccine was given. (hot to the touch)
61 2021-01-20 chest discomfort, hypertension A few minutes after vaccination, developed headache, fatigue and chest heaviness radiating to her ba... Read more
A few minutes after vaccination, developed headache, fatigue and chest heaviness radiating to her back. ST depression noted on EKG. 911 called. Aspirin and oxygen administered. Attended to by onsite RN and paramedic. At ER, significant hypertentsion with SBP>200, ST changes. Normal troponin, no ACS. Was monitored, treated with Norco and later discharged home.
61 2021-01-20 heart rate irregular Patient reports she received Moderna Covid 19 vaccine lot #039K20A on 12/31/2021. Patient reports sh... Read more
Patient reports she received Moderna Covid 19 vaccine lot #039K20A on 12/31/2021. Patient reports she developed fatigue, T 100.8, swelling and hardness at injection site 24-48 hrs after receiving vaccine. Patient self managed with Tylenol and rest. The following week, patient reports she had intermittent odd heart sensation. On 1/12/21 patient noticed a 5-6 inch red itchy mark at injection site. That night, patient developed tinnitus in the right ear. On 1/13/21 patient went to Urgent Care, then saw her otolaryngologist. Patient reports she had an ECG and labs. These tests were normal. On 1/15/21, patient went to PCP. Patient had halter monitor and is awaiting results. PCP submitted referral. Patient is awaiting appointment with allergist and employee health provider. Patient missed 3 days of work. Patient states "redness at injection site is fading and tinnitus is better."
61 2021-01-21 blood pressure increased, heart rate increased Throat felt tight with blood pressure and pulse elevated about 15 minutes after giving vaccine. 30 m... Read more
Throat felt tight with blood pressure and pulse elevated about 15 minutes after giving vaccine. 30 mins after vaccine was given blood pressure and pulse still elevated. 45mins after vaccine was given throat was no longer tight but patient reported lower gums felt swollen. No swelling visable. Blood pressure and pulse remained elevated. Approximately 1 hour after vaccine was administered the patient reported that her gums no longer felt swollen but her blood pressure and pulse remained elevated although had decreased some since initial readings. Decision was made for her to go to the emergency department. Called the patient later in the afternoon on 1/13. She was still in the emergency room. Her blood pressure was still elevated and they were planning on giving her an intravenous medication to try to lower it.
61 2021-01-21 chest discomfort 16 min post Moderna COVID vaccination pt complained of nausea, dizziness, and headache. No s/s of a... Read more
16 min post Moderna COVID vaccination pt complained of nausea, dizziness, and headache. No s/s of anaphylaxis including no respiratory distress, urticaria, or angioedema. 21 min post vaccination patient given 12.5 mg diphenhydramine IM in opposite arm of injection. 35 min post vaccination and after no improvement of symptoms pt given another 12.5 mg of diphenhydramine IM. Pt under continuous observation by RN with normal O2 and HR but with BP ranging from 156/102 - 192/92. During the entire observation no s/s of acute anaphylaxis. Pt denies history of hypertension and denies medication for hypertension. 42 min post vaccination patient symptoms continued and reports chest tightness but no respiratory distress and normal O2. EMS called for transport to hospital. 45 min post vaccination EMS arrived and patient transported to hospital.
61 2021-01-21 fast heart rate, chest discomfort Patient received COVID-19 Moderna. She waited at the clinic site for approximately 20 minutes after ... Read more
Patient received COVID-19 Moderna. She waited at the clinic site for approximately 20 minutes after administration. She left approximately ten minutes later felt her face get hot. She noticed her face was flushing. She noticed tachycardia and some chest tightness while driving. She continued on her errands and began feeling better by 4PM. She reports she did not feel completely better until approximately 8PM.
61 2021-01-24 hypertension wooziness headache (migraine) stiff neck High blood pressure Blurred vision these symptoms las... Read more
wooziness headache (migraine) stiff neck High blood pressure Blurred vision these symptoms lasted for about 2 hours... then cleared but headache turned to dull headache and that lasted for 2 days
61 2021-01-24 fast heart rate tachycardia, dizziness, diaphoresis, weakness, Temp 100.8 F, 911 called, above symptoms resolve... Read more
tachycardia, dizziness, diaphoresis, weakness, Temp 100.8 F, 911 called, above symptoms resolved by the time ambulance arrived.
61 2021-01-26 chest discomfort itching, slight heaviness in chest with cough, very tired went to sleep as so as I arrived home aft... Read more
itching, slight heaviness in chest with cough, very tired went to sleep as so as I arrived home after the shot, red welt on arm around area of injection when awoke in morning.
61 2021-01-26 chest pain c/o dizziness, throat feels funny. Denies SOB, Chest pain, headache. Patient performed her fingersti... Read more
c/o dizziness, throat feels funny. Denies SOB, Chest pain, headache. Patient performed her fingerstick 143 BP: 164/86, 134/90 ( RECHECK); Sp02: 100 RA; HR 86 Seen and cleared by EMS
61 2021-01-26 heart rate increased Left deltoid soreness began within a couple of hours of injection. By 6:00 pm fever, chills, body... Read more
Left deltoid soreness began within a couple of hours of injection. By 6:00 pm fever, chills, body aches, and headache began and persisted through the night. Temperature elevated to 102° for approximately 12 hours. Resting heartrate during the night elevated to 99 - 103 bpm (typically 57 -61 bpm). Treatment was acetaminophen and fluids. Symptoms began subsiding 24 hours post-injection. Fatigue and light headedness persisted for 36 hours.
61 2021-01-26 loss of consciousness, pulse abnormal Pt received second dose of vaccine and went to the observation area. She was risk stratified into th... Read more
Pt received second dose of vaccine and went to the observation area. She was risk stratified into the high risk (30 minute obsevation) category based on a previous anaphylactic response to shelffish requiring epinhephrine. She reported only a minor pruritis after the first dose of the vaccine. While in the observation area she reported auditory exclusion to her male partner, then reportedly went unconcsious immediately. Employees working in the observation area were notified and summoned medical assistance. A medical provider (PA) arrived and found the pt supine in the passenger seat and unresponsive. Her pulse was weak and thready. One dose of 0.3mg epi autoinjector was administered to her R lateral thigh at 12:03p
61 2021-01-26 palpitations After receiving covid vaccine(moderna second dose), began to feel thickening of tongue, raspy voice ... Read more
After receiving covid vaccine(moderna second dose), began to feel thickening of tongue, raspy voice and hard to swallow, numbness of face, very hot, racing heart rate and shakiness. All this happened about 10-12 minutes after injection. taken to ER via cart for evaluation. Pt evaluated in the ED at 1048, given Benadryl and prednisone PO, and discharged at 1213
61 2021-01-27 chest discomfort I had rush in my chest and a taste in my mouth when it was administered then couldnt swallow food 2 ... Read more
I had rush in my chest and a taste in my mouth when it was administered then couldnt swallow food 2 hours later could swallow liquid I took benedryl 3 different times throughout the night, next day could swallow food.
61 2021-01-27 heart rate increased Received vaccine at 3:00 pm. Told to wait in waiting area for 15 min and schedule date for 2nd vacci... Read more
Received vaccine at 3:00 pm. Told to wait in waiting area for 15 min and schedule date for 2nd vaccine. At 3:04 pm, started having a strange body feeling, felt a warm rush from my neck to my groin (like a person having a CT scan with dye), heart rate increased to 127bpm. I stood up and said I'm not feeling well. Staff came, took pulse rate, bp (170s over 90s) walked to a cot and felt shaky legs. Around 3:11pm they gave benadryl 50mg. Staff called a rapid response. I was told i had a rash. They shot me with an epipen and was taken to EMERGENCY DEPT.
61 2021-01-27 palpitations, chest pain Patient has temperature the day after the vaccine (1/23/2021), then felt better. On Monday developed... Read more
Patient has temperature the day after the vaccine (1/23/2021), then felt better. On Monday developed chest pain and palpitations. Admitted to hospital.
61 2021-01-29 chest discomfort PATIENT COMPLAIN OF FEELING ANXIOUS WITH CHEST DISCOMFORT. PATEINT DENIES SHORTNESS OF BREATH . RES... Read more
PATIENT COMPLAIN OF FEELING ANXIOUS WITH CHEST DISCOMFORT. PATEINT DENIES SHORTNESS OF BREATH . RESPIRATIONS 22 HEART RATE 91 O2 SATURATION 98% DENIES CHEST PAIN
61 2021-01-31 chest discomfort Headache the next morning; Headache the day after that, as well (Jan 1). January 2 - developed a li... Read more
Headache the next morning; Headache the day after that, as well (Jan 1). January 2 - developed a little bit of a cough. Got a PCR COVID test and that was on the Jan. 2; on January 3 - achy; tired and that night - low grade fever - (took ibuprofen); January 4 - negative test came back for COVID; Got a different test on the 4th - Posterior -Positive; my symptoms continued (but no fever) - and very tired and really achy. Tuesday - still coughing (5th); on 8th - lost sense of smell for 24 hours and it came back. Continued coughing for a month. Just stopped having cough and chest tightness at end of January. Got second dose on 27th - symptoms repeated except no cough yet.
61 2021-01-31 chest pain Pt reported chest pain as well as headache, blurry vision and dizziness. BP was found to be 208/110... Read more
Pt reported chest pain as well as headache, blurry vision and dizziness. BP was found to be 208/110. EMS was called and pt was transported to ED via private car due to pt not wanting to go by ambulance. Per chart notes, pt presented to ED and also reported hives however she left the ED without being seen.
61 2021-01-31 chest pain Awoke with searing pain in center of sternum. Minimal pain at rest cannot sneeze, breathe deeply, mo... Read more
Awoke with searing pain in center of sternum. Minimal pain at rest cannot sneeze, breathe deeply, mop, vacuum without increased pain. Ibuprofen relieves 80% of pain. The pain is persisting 7 days post vaccine with minimal improvement.
61 2021-02-01 hypertension High blood pressure, dizziness during initial 15 min after vaccination. Symptoms subsided with no f... Read more
High blood pressure, dizziness during initial 15 min after vaccination. Symptoms subsided with no further incident.
61 2021-02-01 low blood oxigenation, fast heart rate Covid positive 1/29/21. 2/1/21, hypoxia, tachycardia. Admitted to hospital 2/1/21. Diagnoses: UT... Read more
Covid positive 1/29/21. 2/1/21, hypoxia, tachycardia. Admitted to hospital 2/1/21. Diagnoses: UTI, Covid-19 infection, hypoxia, sepsis.
61 2021-02-02 pallor Given 1st dose Moderna Covid- 19 vaccine on Jan. 11, 2021 in right deltoid- Ususal tiredness, sl. fa... Read more
Given 1st dose Moderna Covid- 19 vaccine on Jan. 11, 2021 in right deltoid- Ususal tiredness, sl. fatigue, headache later that day. That evening, developed swelling in armpit area into right breast area on side near arm. Used ibuprofen, ice pack for comfort. Next day had body aches, sl. fever, chills. Right arm hurt for 6 days. Armpti swelling reduced by day 4 .On day 4 following vaccine- observed red, swollen, hard area at injection site size of a small saucer. Somwhat blanched white above and below red area. Went away in two days. Used Ibuprofen, ice for comfort. Symptoms subsided in week.
61 2021-02-04 palpitations employee presented to Covid Vaccine Clinic for 2nd Moderna vaccine. Following administration sx onse... Read more
employee presented to Covid Vaccine Clinic for 2nd Moderna vaccine. Following administration sx onset began at 0845: dizziness, a feeling of a "headrush", feeling faint. 0846, BP 100/70, HR 85, shaky. "I just don't feel right, I can't describe it. I feel like my heart is racing, My head feels really weird. My throat feels like it has a little tickle but I can't be sure." NO h/o anxiety, panic, anaphylaxis. 900 am "my throat feels like it is swelling on the inside"
61 2021-02-04 fainting, hypotension Syncope and hypotension. No previous history of syncope. Syncopal episode 20 hours after injection .... Read more
Syncope and hypotension. No previous history of syncope. Syncopal episode 20 hours after injection . Other symptoms were chills, low grade fever, headache. No allergic rxn, no rash. Hypotension lasted for several hours.
61 2021-02-05 heart rate increased Within minutes of receiving the Moderna vaccine, I experienced an odd sensation in my stomach increa... Read more
Within minutes of receiving the Moderna vaccine, I experienced an odd sensation in my stomach increased breathing, HR, lightheadedness, and dizziness. (I experienced a similar reaction years ago but more severe, after having a breast MRI with Gadolinium . I will consult my primary physician by email today. Per consult with a family physician, the recommendation has been advised for possible prophylactic treatment prior to obtaining the second Moderna vaccine. On rereading the composition of the Pfizer/Moderna vaccines, I noted that polyethylene glycol(PEG) is a component in both the Pzifer and Moderna vaccines. I also discovered that PEG is also used with Gadolinium particles in contrast dye. Gadolinium-containing copolymeric chelates. A new potential MR contrast agent. Solvothermal synthesis and functionalization of polyethylene glycol. It leads me to consider whether contrast dye should now be listed as one of the allergens on the vaccination registration forms, in order for persons with this allergy to report this information to their primary physicians prior to obtaining this vaccine.
61 2021-02-05 heart rate increased Swelling in throat started within 5 minutes of receiving the vaccine followed by tingling and numbne... Read more
Swelling in throat started within 5 minutes of receiving the vaccine followed by tingling and numbness in lips, increased heart rate and shaking limbs. Received 25mg of liquid Benadryl within 5 minutes of onset of symptoms. Symptoms completely resolved about 15minutes after taking Benadryl.
61 2021-02-05 palpitations Received the vaccine at 7:00 a.m. on 2/3/21. I woke up at 1:00 a.m on 2/4/21 with a racing heart, s... Read more
Received the vaccine at 7:00 a.m. on 2/3/21. I woke up at 1:00 a.m on 2/4/21 with a racing heart, sweats, severe muscle/joint pain. According to my Watch app., the resting hear rate upon waking was 115.. I had a severe headache and generally felt awful. I took Aleve and did deep breathing to try to bring heart rate down. One hour later it was coming down, although still higher than my normal resting rate of 60. The arm where the injection was given has been extremely sore with a rash, sore enough that it is hard to use the arm. It is now 3 days since the vaccine, my heart rate has been normal. My arm pain is reduced but still sore with a rash. I feel fatigued and foggy. The severe joint pain is less but still present.
61 2021-02-07 blood glucose increased, pallor, fainting 2/4/21 slight headache during day, tired. Cold on and off, cold feet throughout the day. 5:30pm got ... Read more
2/4/21 slight headache during day, tired. Cold on and off, cold feet throughout the day. 5:30pm got home from work had shaking chills, unable to get warm for 2 hours. Finally got warm but it was a hot warmth. No fever. Took Tylenol 500mg. The warmth continued and had mild headache. Took 500mg Tylenol at bedtime 11pm. I was hot throughout the night ( no sweats ) woke at 6am feeling light headed and dizzy, body aches, still hot. Felt like I had the flu. I went into the bathroom to void. I remember thinking - I am too sick to go to work. My husband said I was standing holding onto the door, white in color, said "i'm sick" he came to stand beside me to help me walk and I passed out. I had loss of consciousness. I do not know how long - he said he tried to shake me to wake me up about 30 seconds. He yelled to my son sleeping upstairs a few times, they got the phone and called 911. He said I vomited a few times and would not wake up. I remember coming to - sitting on the floor with him talking to 911 . I woke up enough to get up and walk to the living room couch with assist and gradually starting feeling better. The paramedics came and took my vital signs. Blood pressure (120/69 ), heart rate (84) oxygen saturations were all good. Blood glucose 116. I declined ER transport. I had continued light headedness, dizziness 2/6, 2/7/21. Arm soreness gone at injection site on 2/7/21. I believe the dizziness is a mild concussion. I have a provider appointment 2/9/21.
61 2021-02-07 chest discomfort fever, myalgias, arm pain, abdominal pain and chest tightness
61 2021-02-07 heart rate increased Around 11:00 P.M. the (evening of the day I received the 2nd dose) I started experiencing symptoms: ... Read more
Around 11:00 P.M. the (evening of the day I received the 2nd dose) I started experiencing symptoms: I experienced Fever,, body aches, jaw pain (my teeth hurt), injection site pain, fatigue, headache, muscle pain, joint pain, chills, nausea, weakness, and a fast heartbeat Of course, I did not sleep well. . At around 11:00 the next morning all symptoms had subsided with the exception of feeling exhausted. I was using v-safe to report my symptoms but never received any reminders about the second shot, and did not get a reminder until Sunday, which of course by then, all symptoms were gone and answered how I felt that day which was fine. I just felt it was important to report the symptoms accurately.
61 2021-02-07 hypertension Nausea, fever, high blood pleasure, heart burn, head ache, sore arm, left leg cramps, fatigue, chill... Read more
Nausea, fever, high blood pleasure, heart burn, head ache, sore arm, left leg cramps, fatigue, chills, sore throat, runny nose.
61 2021-02-08 chest discomfort Patient received 1st dose of Moderna vaccine on 2.6.2021 at approximately 1030. By 1500 that day the... Read more
Patient received 1st dose of Moderna vaccine on 2.6.2021 at approximately 1030. By 1500 that day the patient describes the following symptoms: intolerable pain (9 out of 10), chest pressure, extreme weakness and fatigue, itching all over with a rash, shaking, dizziness, vomiting, and diarrhea. Patient says she saw some improvement after 24 hours, but still is having some diarrhea today (2.9.21). Recommended patient to contact PCP with symptoms.
61 2021-02-08 heart rate increased, chest discomfort Heart pulse goes from 83 to 170 several time in the past 20 hours. At least 7 or 8 times we know abo... Read more
Heart pulse goes from 83 to 170 several time in the past 20 hours. At least 7 or 8 times we know about. Tightness in the throat and chest. Slight headaches. Fatigue.
61 2021-02-08 palpitations 10 minutes after receiving vaccine I had sudden sharp pains in my right ear. I have had extensive s... Read more
10 minutes after receiving vaccine I had sudden sharp pains in my right ear. I have had extensive surgery in and around that ear due to cholesteatoma and perilymph fistula, and I have had some nerve damage to the balance nerve. The bones of hearing have been removed and replaced with titanium artificial bones that do not work, so I am deaf in that ear. These pains were severe, as if a number of steak knives were stabbing me at once, but the pain only lasted about a minute and subsided. 3 or 4 minutes later the pain recurred exactly as before but lasted a shorter duration and at a lower level of pain. The ear felt congested the rest of the day and I avoided driving after getting home. I have had no further problems, except that I went for more dental work on 2/8, and had a dizzy spell after getting anesthetic, maybe a little heart racing for just 5 minutes or so.
61 2021-02-09 blood glucose increased Allergie to ASA-anaphylactic
61 2021-02-09 chest discomfort Itchy mouth and throat, red blotchy face, tight chest and bright red cheeks
61 2021-02-09 loss of consciousness Approximately 24 hours after given 2nd covid vaccine injection patient was sitting at bedside of a f... Read more
Approximately 24 hours after given 2nd covid vaccine injection patient was sitting at bedside of a family member that came to hospital ED. She passed out and fell to floor. Lost her pulse and ED staff began CPR. She got her pulse back and woke up and said I am okay. Doctor seeing her ordered labs, EKG, Echocardiogram , chest xray, cardiac enzymes. All tests were normal. ED doctor told patient the only thing they could contribute this to was her covid vaccine she got the day before. She was admitted to the facility for further observation for the next 24 hours.
61 2021-02-10 chest discomfort 8:15am. Itching in face, then back and hands 8:20 am tightness in chest,
61 2021-02-10 chest discomfort "Received second Injection 1-26-21 Next day experienced mild headache, moderate muscle and neck pain... Read more
"Received second Injection 1-26-21 Next day experienced mild headache, moderate muscle and neck pain, skin extremely sensitive to the touch, and fatigue. This resolved about 36 hours after the injection. Was feeling fine until today 2/3/21 (one week after injection) . New symptoms developed as I am now feeling like I have tightness in my lungs when I breathe with mild difficulty. (kind of like when I have a chest cold). Also my throat feels funny like my trachea hurts.I have been reporting daily with the CDC app as suggested and have reported these symptoms as well."
61 2021-02-10 chest pain 10 minutes after dose the patient started having dyspnea, lightheadedness, chest pain, weakness, and... Read more
10 minutes after dose the patient started having dyspnea, lightheadedness, chest pain, weakness, and headache. Epinephrine 0.3 mg IM was administered prior to transport to the ED. Ipratropium-albuterol 0.5-2.5 mg/3 mL nebulizer solution, dexamethasone 10 mg IV and Diphenhydramine 50 mg IV were administered in ED. Patient was discharged after resolution of symptoms (2.5 hours after administration of vaccine).
61 2021-02-10 heart rate increased Patient complained heart rasing 10 minutes after getting vaccine Moderna vaccine 2nd dose.
61 2021-02-10 palpitations 1 1/2 WEEK AFTER VACCINE HAD HEART PALPATATIONS THAT LASTED 45 MINUTES. PATIENT STATES SHE HAD THIS... Read more
1 1/2 WEEK AFTER VACCINE HAD HEART PALPATATIONS THAT LASTED 45 MINUTES. PATIENT STATES SHE HAD THIS HAPPEN ONCE BEFORE MANY YEARS AGO BUT ISN'T SURE IF ITS THE VACCINE OR NOT. ALSO HAD PAIN, SWELLING, AND RASH AT THE INJECTION SITE.
61 2021-02-10 palpitations Date and time of vaccination: #1 Jan 4, 2021 @1100 #2 2/1/2021 @0900 Brand and lot of vaccine:... Read more
Date and time of vaccination: #1 Jan 4, 2021 @1100 #2 2/1/2021 @0900 Brand and lot of vaccine: #1Moderna lot 011L20A #2Moderna lot 012M20N (hard to read) palpitations
61 2021-02-10 fainting The patient felt fine immediately after the vaccine which was at 3pm 2/10. She reports having diffic... Read more
The patient felt fine immediately after the vaccine which was at 3pm 2/10. She reports having difficulty sleeping and awoke with a headache. When she got out of bed, a few after getting up, she felt dizzy and decided to get back in bed however she fainted and fell onto the floor. She also reports nausea.
61 2021-02-11 chest discomfort SHE WAS EXPERIENCING PRESSURE IN HER CHEST AND LIGHTHEADEDNESS APPROXIMATLEY 10 MINUTES AFTER RECIE... Read more
SHE WAS EXPERIENCING PRESSURE IN HER CHEST AND LIGHTHEADEDNESS APPROXIMATLEY 10 MINUTES AFTER RECIEVING VACCINE. ONSITE EMS WAS REQUESTED. VITALS WER BP 190/116 HR 90 AND EKG SHOWED NORAL SINUS RHYTHM. PATIENT HAS NEVER EXPERIENCE REACTION TO VACCINE BUT SHE HAS NOT HAD ANY VACCINE SINCE SHE WAS A KID. SHE STATED SHE WAS NERVOUS ABOUR RECEIVING THE VACCINE PHYSICIAL ON SCENE RECOMMNED THA TH PATIENT TO TO THE ER DUE TO HYPERTENSION. RATIENT REFUSE SAYS SHE WILL GO HOME AND TAKE HER LOSARTAN.
61 2021-02-11 nosebleed nosebleeds got worse where she was filling up towels with blood; sore throat; cough; A solicited rep... Read more
nosebleeds got worse where she was filling up towels with blood; sore throat; cough; A solicited report was received from a 61-year-old female patient, who who received Moderna's COVID-19 vaccine (mRNA-1273) developed significant nosebleeds where she was filling up towels full of blood, sore throat and coughing during and after her Tyvaso session. The patient's medical history included Secondary Pulmonary Arterial Hypertension. Products known to have been used by the patient within two weeks prior to the event was Sildenafil Citrate. Additional suspected products included Treprostinil Sodium, Plavix, and Aspirin. On an unknown date, the patient received one of two planned doses of mRNA-1273 (Lot: unknown) for prophylaxis of COVID-19 infection. On an unknown date, after receiving the vaccine, the patient experienced worsening of nosebleeds filling up towels full of blood, sore throat and coughing. Treatment for the events, nosebleed, sore throat and cough was not reported. Action taken with second dose of mRNA-1273 in response to the events was not reported. The event, worsening of nosebleeds filling up towels full of blood was considered not resolved and outcome of the events, sore throat and cough was not reported.; Reporter's Comments: This case concerns a 61 year old female patient with medical history of Secondary Pulmonary Arterial Hypertension, who experienced a serious unexpected event of Epistaxis and NS events of oropharyngeal pain and cough. The events occurred on an unknown date after first dose of the study medication administration. A causal relationship cannot be excluded. Noting the subject's underlying medical condition and concomitant medication could remain a confounder.
61 2021-02-11 hypotension 2 days post-vaccination developed rash, muscle aches, nausea, diarrhea, vomiting and fever. 10 days... Read more
2 days post-vaccination developed rash, muscle aches, nausea, diarrhea, vomiting and fever. 10 days post-vaccination admitted to hospital with acute kidney injury and hypotension. Released on oral steroids for presumed hypersensitivity reaction. Admitted second time 36 days post-vaccination rapid worsening of rash, nausea, vomiting, diarrhea, fever and hypotension. Discharged to community on oral steroids
61 2021-02-12 heart rate increased After 15min wait patient had glassy eyes and shaky left hand ,increased heart rate ND low glucose. A... Read more
After 15min wait patient had glassy eyes and shaky left hand ,increased heart rate ND low glucose. After being observed 30 min more patient was alright to drive. A follow up phone call was made patient was doing fine some pain at injection site.
61 2021-02-14 lightheadedness Vasovagal resulting hitting head and causing a concussion.
61 2021-02-14 fast heart rate 2/10/21 - 915AM - tachycardia for 10 minutes - 30 minutes after receiving vaccine. 2/11/21 - 8AM - i... Read more
2/10/21 - 915AM - tachycardia for 10 minutes - 30 minutes after receiving vaccine. 2/11/21 - 8AM - injection site stiffness, swelling, redness, hot to touch body aches with severe headache and nausea inability to focus at work (RN duties) 2/11/21 - 12PM - Sent home from work - tylenol for pain/headache, slept for 18 hours. 2/12/21 - 8AM - Returned to work - body aches resolved - headache controlled with tylenol, Feeling of fatigue Continued injection site tenderness, swelling and redness 2/13/21 - Symptoms resolved
61 2021-02-15 heart rate increased, palpitations 1500 FELT "PALPIATATIONS" AND FACIAL FLUSHING EPISODE IN IN HE LAST 10 MINUTES, RESOLVED SPONTANEOU... Read more
1500 FELT "PALPIATATIONS" AND FACIAL FLUSHING EPISODE IN IN HE LAST 10 MINUTES, RESOLVED SPONTANEOUSLY 1504 BLOOD PRESSURE 75/86, HR 105 O2 100%; HEART RATE REGULAR AND RAPID, FEELS FLUSHED HEART RACING. PATIENT REPORTS SEIZURE EPISODE LAST NIGHT 1511 BP 54/87 HR 99 O2 99%, PATIENT STATES SHES FEELING BETTER 1530 PATIENT FEELING MUCH BETTER. INSTRUSTED TO SEEK EMERGENCY MEDICAL ASSISTANCE IF SYMPTOMS RETURN
61 2021-02-15 hypertension, fast heart rate Patient had post vaccine tachycardia, tremor, hypertension requiring phone call to 911 + prolonged o... Read more
Patient had post vaccine tachycardia, tremor, hypertension requiring phone call to 911 + prolonged observation
61 2021-02-17 blood pressure increased, chest pain Burning at site.. immediately feeling lightheaded, heavy chest pains within 3 minutes and maintain... Read more
Burning at site.. immediately feeling lightheaded, heavy chest pains within 3 minutes and maintained for two hours Rapid rise in Blood Pressure within 5 minutes of injection staying at over 180/109 for two hours Hives 90 minutes after injection Sharp pain in facial nerves, neck lasting days
61 2021-02-18 heart flutter All of a sudden the flutters would come and I would have headaches when I first got up in the mornin... Read more
All of a sudden the flutters would come and I would have headaches when I first got up in the morning. I had body aches, would last all day and I already had pain in the knees but seem more than usual. The pain in the knees come and go.
61 2021-02-18 chest pain 1st vaccine 2/13/2021; 20 mins post vaccination developed flushing and since developed HA, and CP on... Read more
1st vaccine 2/13/2021; 20 mins post vaccination developed flushing and since developed HA, and CP onset 2/19/21. seen in ED 2/19/21 and admitted to hospital for additional workup; Dx on admission: Chest pain, unspecified type ;Acute nonintractable headache, unspecified headache type; Hepatic steatosis.
61 2021-02-18 nosebleed Epistaxis
61 2021-02-19 palpitations woke with unusual itching all over scalp in middle of the night. two hours later, awoke again shaki... Read more
woke with unusual itching all over scalp in middle of the night. two hours later, awoke again shaking uncontrollably. no fever. shortness of breath. heart pounding 180 beats/min this continued for 45 minutes. shortness of breath continued 10 days. feeling fatigued since then. unsure if I should take second dose of vaccine in a week.
61 2021-02-19 fast heart rate, palpitations heart palpitations starting 3 days later, continued 1X/daily; on day 21 had tachycardia HR 136-148 f... Read more
heart palpitations starting 3 days later, continued 1X/daily; on day 21 had tachycardia HR 136-148 for 3 hours; on day 23 had tachycardia HR > 170 -- lasted about 30 minutes, seen at ER but had already started to come down. After that, have not had strong palpitations or tachycardia.
61 2021-02-23 blood pressure increased arm sore and swollen at injection site, fatigue, a little light headed, occasional chills, occasiona... Read more
arm sore and swollen at injection site, fatigue, a little light headed, occasional chills, occasional nausea, elevated blood pressure day of shot
61 2021-02-23 blood pressure increased At vaccination site 30 minutes after 2nd dose vaccination I started having numbness in my front teet... Read more
At vaccination site 30 minutes after 2nd dose vaccination I started having numbness in my front teeth then quickly went to nose, lips, roof of mouth and throat. Honked horn physician came over, performed simple neurologic test and advised allergic reaction. Had me roll down windows and sip water and to wait another 10-15 minutes. After 5 minutes throat and nose felt like they were closing. Paramedics came over and checked BP, which was elevated, and blood sugar which was very low. They continued to monitor me until symptoms started subsiding. Asked if I wanted to go to ER, declined. They recommended me to take 50 mg of Benadryl and to go to ER or call 911 if symptoms persisted or worsened. Took Benadryl within 15 minutes of leaving and about 10 minutes afterwards all symptoms were gone.
61 2021-02-24 fainting Woke during the night (approx 11hrs post-vaccine) with 10/10 joint pain in shoulders and hips, unabl... Read more
Woke during the night (approx 11hrs post-vaccine) with 10/10 joint pain in shoulders and hips, unable to get comfortable; continued with pain, extreme weakness, exhaustion, nausea, and mild headache until approx 5pm the day after vaccine (Day 2). Slept most of the day and through the following night. Fainted x1 first thing in the morning; Vomited x1 after small snack and tea; unable to eat all day. Symptoms resolved by day 3 and able to go to work
61 2021-02-25 low blood platelet count Received notification from county director that patient is currently hospitalized beginning two days... Read more
Received notification from county director that patient is currently hospitalized beginning two days after Moderna vaccination, spoke to patient today 2/26/2021. Patient received vaccine Monday morning 2/22/2021 around 9:07am, by 9pm Monday evening patient reports weakness, fatigue, sore arm, fever, chills, and no appetite. Patient states symptoms persisted all day Tuesday 2/23/2021. On Wednesday 2/24/2021 at 11:30am patient was eating a peanut butter sandwich and felt something inside mouth. Upon looking in mouth patient noticed "black sores." Patient then called husband and was taken to ER and was then transferred to Hospital. Patient states she has been diagnosed with ITP idiopathic thrombocytopenic purpura.
61 2021-02-25 palpitations, pulse abnormal 1505 c/o palpitations; heart flip flopping and light-headed 1509 BP 170/98 P 135 R 16 SpO2 96% A... Read more
1505 c/o palpitations; heart flip flopping and light-headed 1509 BP 170/98 P 135 R 16 SpO2 96% Alert and oriented x 3; skin pale, cool and clammy; resps unlabored; pulse weak and heart bounding and regular - very rapid; no rash VS repeated every 5 min without appreciated stabilization. Assessment remained the same EMS called 1520. EMS arrival 1527; care handed off and report given. Client declined to be transported to the emergency room and was dispositioned home with instructions to go to the ED if symptoms do not abate or worsen. BP and P remain elevated on disposition per EMS (Fire Dept EMS).
61 2021-02-25 palpitations After 45 minutes of receiving vaccination , the knuckles in my left hand, the arm I received the sho... Read more
After 45 minutes of receiving vaccination , the knuckles in my left hand, the arm I received the shot in, began to hurt very badly. Before I was able to get home, 7 minutes away, both hands hurt so bad I couldn't hole the steering wheel and I was having cramps in my legs. I could hardly walk up the steps to my house because my ankle joints hurt so badly. I went to bed right away and slept . My hands hurt really badly, but I knew the vaccination caused an inflammatory response so I figured just rest. By the end of the day Tuesday, I couldn't type and could not hold the steering wheel to drive home. I felt out of breath, I hurt all over, my muscles ached and were cramping. I was nauseated, very emotional. I had a fever that spiked at over 101 degrees. I was so chilled that I was shaking violently. I hurt in every joint, my lymph nodes were painfully swollen, my heart was racing, normal pulse for me is 68 to 72, it was 88 to 90. Halfway up our stairs, I just stopped, couldn't make my legs work. Day 3 I called my doctor, had a virtual appointment I knew I couldn't drive or ride 45 minutes away. I missed 3 days of work, stayed home all weekend and was better by Monday. It was 3 weeks before my hands quit aching. The pain came and went in my ankles, wrist, knuckles, hips and knees. Food still nauseates me.
61 2021-02-27 fainting Unable to focus eyes, dizzy, faint, falling over started 2 hrs after injection. Extreme tiredness 3 ... Read more
Unable to focus eyes, dizzy, faint, falling over started 2 hrs after injection. Extreme tiredness 3 hrs after injection so bad couldn?t get up. Symptoms lasted 24 hrs. Soreness in arm, shoulder then neck of left side injection prohibiting sleep 48 hrs after injection.
61 2021-02-28 chest discomfort Acute anaphylactic reaction. Presented with dyspnea, wheeze and chest tightness. Received IM epi 0... Read more
Acute anaphylactic reaction. Presented with dyspnea, wheeze and chest tightness. Received IM epi 0.4mg x 2 - 20 minutes apart, IV Benadryl (50mg) and solumedrol IV 125, continuous albuterol med x 1 hr.
61 2021-02-28 chest discomfort 102 fever, aching in neck and shoulders area, lymph nodes under left arm pain and swelling, arm sore... Read more
102 fever, aching in neck and shoulders area, lymph nodes under left arm pain and swelling, arm soreness and warm to touch, chills, headache, mild tightness in middle of chest, teeth hurthing.
61 2021-03-01 fast heart rate The patient received her second Moderna inoculation January 20, 2021 at 8 a.m. At around 7:30 p.m.,... Read more
The patient received her second Moderna inoculation January 20, 2021 at 8 a.m. At around 7:30 p.m., she had a sudden onset of myalgias and chills. Within 30 minutes, she had a fever at 99.9° F. She went to bed without taking acetaminophen or NSAIDs based on new CDC recommendations of how to treat symptoms due to the COVID-19 vaccine. The patient hydrated and went to bed around 9 p.m. By 11 p.m., the patient?s fever was 100.4° F., accompanied by intense myalgias, chills and a migraine headache. She woke again at 1 a.m. with a fever of 101° F. At 2 a.m., she woke with right-sided pleuritic chest pain (severe pain with inspiration, some pain with expiration and no pain with holding of the breath), with her fever persisting at 101° F. And tachycardia to 109. By 7:30 a.m., her fever dropped to 100.4° F. But still tachycardia at 101. At this time, she took ubrogepant 50 mg, with resolution of her headache within about 30 minutes. Because she had rhinorrhea at this time, she decided to get tested for COVID-19 that day.
61 2021-03-03 chest discomfort A day and a half after: Hives, tightness in chest, cough; day after: extreme fatigue; steroid to tre... Read more
A day and a half after: Hives, tightness in chest, cough; day after: extreme fatigue; steroid to treat: methylprednisolone
61 2021-03-04 blood glucose increased, heart rate increased, chest discomfort Patient was complaining of chest tightness and increased heart rate around 15 minutes of receiving t... Read more
Patient was complaining of chest tightness and increased heart rate around 15 minutes of receiving the vaccination. Was given 50 mg Bendadryl IM for treatment and patient was monitored for an additional 30 minutes. Symptoms were relieved upon patient exit.
61 2021-03-04 fast heart rate PT PRESENTED WITH HYPERVENTILATION, TINGLING AND BENIGN TREMORS IN HANDS AND FEET. TACHYCARDIA, NA... Read more
PT PRESENTED WITH HYPERVENTILATION, TINGLING AND BENIGN TREMORS IN HANDS AND FEET. TACHYCARDIA, NAUSEA. VITALS: BP 126/85 AND 132/78; REPEAT 102/68 AND 112/68 AT 2:58 HR 97 RR 20 O2 98% THE ABOVE CONDITIONS RESOLVED ON THEIR OWN WITHOUT MEDICATION GIVEN. PT DRUNK GATORADE AND STATED THAT SHE FELT BETTER. AFTER 10 MINUTES OF OBSERVATION, SHE LEFT WITH HER HUSBAND DRIVING THE CAR.
61 2021-03-05 haemoglobin decreased Enlarged lymph left side in arm pit and neck, lower abdominal pain that resulted in Rectus Sheath He... Read more
Enlarged lymph left side in arm pit and neck, lower abdominal pain that resulted in Rectus Sheath Hematoma 6 days after second vaccine 2/24/2021. Treated for pain control and administered IV fluids.
61 2021-03-08 atrial fibrillation, heart rate increased Patient had first COVID -MODERNA immunization on 1/6/2021 (chills and fever for one day) and 2/23/20... Read more
Patient had first COVID -MODERNA immunization on 1/6/2021 (chills and fever for one day) and 2/23/2021. Patient began feeling weak, nauseated and dizzy. She was evaluated at the ER on 2/22/2021. She was given fluids and sent home. She continued to feel weak, dizzy and nauseated. She experienced elevated heart rate. She went back to the ER on 2/23/2021. She was diagnosed with atrial fibrillation.
61 2021-03-08 blood pressure increased Blood pressure spiked for 6 weeks post first dose...jumped 50 points
61 2021-03-08 fainting Within in 30 minutes of administration she felt nasal stuffiness that lasted 1-2 hours. 10 hours a... Read more
Within in 30 minutes of administration she felt nasal stuffiness that lasted 1-2 hours. 10 hours after administration she developed fatigue but could not sleep. 12 hours after administration she developed severe chills that made her teeth chatter beyond control x 2 hours. She also reported severe joint and muscle pain. Saturday she felt nausea, aching and fatigue. Sunday (40 hours after vaccine was given) she developed syncope and fell hitting her head. Her B/P at that time was 89/49. Her b/p was checked numerous times after that and stayed low for about 24 hours. She missed work d/t this on Monday 3/8/21.
61 2021-03-09 heart rate increased, palpitations Received vaccine at 2:15pm on Friday 3/5/21. At 7:15pm on Friday 3/5/21, began feeling slight throa... Read more
Received vaccine at 2:15pm on Friday 3/5/21. At 7:15pm on Friday 3/5/21, began feeling slight throat tightness then Tingling sensation in Lips, Numb Nose, Rapid and Heavy Pounding Heartbeat, Tingling in front half of Tongue. Went outside to take breaths of cool air twice and then took 2 Bayer aspirin. Event lasted for about 30 minutes. After the issues passed, continued to have slight tingling in tongue and metallic taste in mouth until Tuesday morning 3/10/21.
61 2021-03-11 loss of consciousness malaise, nausea, vomiting, headache, chills, momentary loss of consciousness
61 2021-03-11 palpitations 30 minutes after the shot I felt an allergic reaction happening, My lips began itch, the lips and su... Read more
30 minutes after the shot I felt an allergic reaction happening, My lips began itch, the lips and surrounding skin area and tip of tongue began to swell. I felt lightheaded and weak, my heart began to race. I had a small amount of difficulty breathing. 45 minutes after shot I took 2 Benadryl. The symptoms began to come and go. I then bean to feel the rush of the reaction making feel if as I needed to vomit and evacuate my bowels luckily it stopped before that happened. I took 2 Pepcid which seemed to keep it in check. The reaction completely subsided about 28-30 hrs. after starting. (also Pepcid the next morning, Xyzal in the evening and morning.
61 2021-03-12 chest pain Systemic: Patient started with a fever overnight beginning at 9pm, got up and went to work and start... Read more
Systemic: Patient started with a fever overnight beginning at 9pm, got up and went to work and started developing shortness f breath and chest pain. She worked for 6 hours and went to the ER. She was diagnosed with a UTI and elevated troponin levels-Severe, Additional Details: Her BP on admission was 178/100, troponin levels went down, she was NPO the next day and then went home.
61 2021-03-12 nosebleed I started developing a fever of 100.2 around 11:30pm on 2/3/21, 13 hours after receiving the vaccin... Read more
I started developing a fever of 100.2 around 11:30pm on 2/3/21, 13 hours after receiving the vaccine. My fever rose to 101.3 by the following morning. It started to drop to 100.2 again by 9:30pm on 2/4/21 and was 99.5 by 10am 2/5/21. I had a severe headache that started as gentle pressure about 2 hours after being vaccinated and escalated to feeling like my head was in a vice through the morning of 2/5/21. I had severe hip and knee joint pain and muscle pain all of 2/4. I was unable to walk because it hurt badly to put weight on my joints. I had a stiff neck and couldn?t turn my head more than 45% in either direction. I slept no more than 20 mins that night due to the pain. On 2/4 I developed nose bleeds and incontinence. Those symptoms went away by 2/5. Dizziness and lightheadedness, fatigue and headache stayed with me for 2 weeks. I am still more tired than usual.
61 2021-03-12 palpitations, heart rate increased Immediately following the shot I became lightheaded and stayed longer than the mandatory 15 minutes.... Read more
Immediately following the shot I became lightheaded and stayed longer than the mandatory 15 minutes. Later that evening My are was sore and I continued to be dizzy. By nighttime I felt achy and tired. About 6 hours after the shot a fever started and I took Tylenol. By 1am I had 101.3, the rigors and a headache and dizziness which I still have 4 days later. My fever ran for over 48 hours and would not respond to any ibuprofen or Tylenol. My joint and muscle pain was severe, my balance was off. I could barely move my arm. Today I am now nauseous. I was not this sick when I had Covid. My fever would at least relent. I?ve lost time from work and my life. I have heart palpitations and my resting heart rate has gone up. Pressure feels strange behind my eyes. My legs are sore. I called my doctor two days after my vaccine and she minimized my symptoms.
61 2021-03-13 heart rate increased tingling in cheek and jaw, then fast heart rate
61 2021-03-14 blood pressure increased During 3rd week after vaccine, I experienced severe fluid retention through my body to include chest... Read more
During 3rd week after vaccine, I experienced severe fluid retention through my body to include chest area; numbness/muscle spasm; and elevated blood pressure.
61 2021-03-14 hypertension, palpitations 5 minutes post vaccination patient patient informed pharmacist on staff she had blurred vision. Pha... Read more
5 minutes post vaccination patient patient informed pharmacist on staff she had blurred vision. Pharmacist had her sit and took her blood pressure (143/95). She reported nausea and heart palpitations shortly following, upon which a manager (Trish) accompanied her to the bathroom. Patient denies vomiting. At 4:50pm patient Blood Pressure was 147/98. Patient reported resolution of nausea, blurred vision, and heart palpitations. Patient states she took her medication as prescribed today. denies taking meclizine today. Patient released to friend who drove her home.
61 2021-03-14 hypertension After The Vaccination, patient experienced soreness at site. The following day, patient experienced ... Read more
After The Vaccination, patient experienced soreness at site. The following day, patient experienced chills, and an intense headache. Since the vaccination, patient has experienced daily migraines, and random episodes of high blood pressure.
61 2021-03-14 hypertension I started with a headache,nausea that progressively got worse on Tues. I went to ER exp sharp pain b... Read more
I started with a headache,nausea that progressively got worse on Tues. I went to ER exp sharp pain behind left eye ear, left jaw was tightening during pain of the headache.
61 2021-03-14 loss of consciousness I lost consciousness for several minutes. I had some tremors coming out of it, and vomiting. Othe... Read more
I lost consciousness for several minutes. I had some tremors coming out of it, and vomiting. Otherwise, expected arm soreness, tiredness, etc. for a few days.
61 2021-03-15 blood glucose increased Blood sugar level was 110 when I got there and within 20 minutes it was up to 250. I used my insulin... Read more
Blood sugar level was 110 when I got there and within 20 minutes it was up to 250. I used my insulin pump to get it back down. found out later that the vaccine contains sucrose and my blood sugar went up after receiving the vaccine. I am type 1 diabetic. it took 8 hours to get my blood sugar back down to normal.
61 2021-03-15 chest discomfort Vomiting, chest heaviness, red/hot/swollen face and fever of 102. Resolved after 48 hours. Did not... Read more
Vomiting, chest heaviness, red/hot/swollen face and fever of 102. Resolved after 48 hours. Did not seek medical attention
61 2021-03-15 chest discomfort THE FIRST EVENING AND THROUGH OUT THE NIGHT I WAS EXPERIENCING A TIGHTNESS IN MY CHEST BUT THE NEXT ... Read more
THE FIRST EVENING AND THROUGH OUT THE NIGHT I WAS EXPERIENCING A TIGHTNESS IN MY CHEST BUT THE NEXT MORNING IT SUBSIDED. THEN THE NEXT MORNING AND FOR TWO WEEKS I WAS UNABLE TO BREATHE DEEPLY SINCE I WOULD ERUPT IN A COUGHING FIT AS IF I WAS EXPERIENCING AN ASTHMA ATTACK-BUT NEVER HAS ONE. MY INJECTED ARM WAS VERY SORE FOR 10 DAYS.
61 2021-03-15 heart rate increased Reported "rapid heart rate" after vaccine. Pulse 135, BP 223/102. Otherwise appeared well. No other... Read more
Reported "rapid heart rate" after vaccine. Pulse 135, BP 223/102. Otherwise appeared well. No other c/o of any adverse reaction sxs. Reported being nervous about getting vaccine. MD was present. MD Stat was called, and MD and RN responded. BP rechecked 214/98, Pulse 133. Patient taken to ER via w/c per MD order. She was conversant throughout, and other than feeling heartbeat "faster" had no other symptoms. She ambulated to gurney in ER and report was given to RN who assumed patient care.
61 2021-03-15 palpitations, lightheadedness Pt developed palpitations 3.5 hrs after dose (along w/nausea, malaise, fatigue). She did not require... Read more
Pt developed palpitations 3.5 hrs after dose (along w/nausea, malaise, fatigue). She did not require ED or office eval, just monitored on her own. Then 3/13 pt had a presyncopal episode w/profound weakness sensation, flushing and nausea
61 2021-03-16 chest discomfort severe pain at shot site. bad headaches. fatigue. heavy feeling in chest. All lasted about 36 hours ... Read more
severe pain at shot site. bad headaches. fatigue. heavy feeling in chest. All lasted about 36 hours from time of vaccination. Took tylenol several times. All symptoms are now gone.
61 2021-03-16 chest pain Severe chest pain, shortness breath, blood vessels bursting all over legs and hands
61 2021-03-16 hypotension, fainting Syncope, hypotension
61 2021-03-17 blood pressure decreased, skin turning blue, palpitations 8:00 Moderna Vaccine given (first dose) 8:14 Patient head was wobbly, face puffy, lips cyanotic, BP ... Read more
8:00 Moderna Vaccine given (first dose) 8:14 Patient head was wobbly, face puffy, lips cyanotic, BP dropped to 110/74, pt c/o palpitations, dizziness and weakness of lower extremeties, O2 administered 8:20 Administered 1 ml of Adrenalin IM on left arm- patient felt better with only c/o weakness of the legs, profusion on lips noted 8:45 Paramedics came, no other medications given and brought patient to hospital for further evaluation
61 2021-03-17 palpitations Patient reports that she feels like her heart is racing, flushed face, and numbness and tingling to... Read more
Patient reports that she feels like her heart is racing, flushed face, and numbness and tingling to extremities and feels anxious. Patient denies CP, SOB, throat fullness, difficulty swallowing. Patient reported that she had a similar reaction after having cortizone injection a couple of weeks ago. Patients vitals were continously monitored , an EKG was ordered as heart rate was 122 on examination. before discharge her vitals were BP 130/80, HB 84/ oxygen levels 99%. Our Medical Director saw patient before discharge and recommended tha she go to ER for safety. Patient declined. Patient was called at 4:47 pm to check her status. Patient said feeling better.
61 2021-03-17 superficial blood clot blood clot (superficial) developed four days after vacccine.. No prior history of blood clots.
61 2021-03-18 blood pressure decreased, blood pressure increased 5-10 minutes after administration, patient experienced the following adverse reactions to her first ... Read more
5-10 minutes after administration, patient experienced the following adverse reactions to her first dose COVID Vaccine: On-site Lead medical physician, MD, was notified and patient was moved from observation open area to sectioned area for patient care. Nausea/vomiting, sweating, shaking, decreased blood pressure (90/40), tingling tongue. Patient was given 25 mg Benadryl per oral. 911 was called . Patient's blood pressure increased to 100/60 within 5 minutes. Patient's condition improved prior to EMT transport.
61 2021-03-18 palpitations Fever, sore arm, tired, headache, and palpitations. No treatment was sought by the patient.
61 2021-03-19 chest discomfort, chest pain I felt a burning and heavy sensation in my chest (diaphragm ) and sick to my stomach feeling. I can ... Read more
I felt a burning and heavy sensation in my chest (diaphragm ) and sick to my stomach feeling. I can actually smell the medication in my nostrils. I did not eat anything before I got my shot.
61 2021-03-19 palpitations Complained of racing heart (pulse 74). BP 156/85, O2 sat 99%.
61 2021-03-21 pallor Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / ... Read more
Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Severe, Additional Details: occured about one hour after shot upon patient trying to jog. Besides above symptoms, pt. became very pale. Recovered after resting and drinking water
61 2021-03-22 heart failure Chills fever diarrhea in the evening, short of breath next day with exertions, continued decreased a... Read more
Chills fever diarrhea in the evening, short of breath next day with exertions, continued decreased activity tolerance until unable to go up one flight of stairs without fatigue and SOB, after 1 week slight foot swelling, 2 weeks, swelling of left foot and leg (pitting). Increased weight gain on 5 pounds, abdominal bloating. Had cardiac blood test come back abnormal showing heart failure, DVT ruled out, echo showed LA enlargement mitral tricuspid prolapse, increase RA pressure. While scheduling abdominal scan swelling went away. Repeated bloodwork and it came back normal. Stress test 3 weeks later normal. Plan to repeat echo in 6 months
61 2021-03-23 chest pain, loss of consciousness, fast heart rate Right hand feels tingly with numbness; Moderate chest pains; Passed out in chair; Super dizzy; Suffo... Read more
Right hand feels tingly with numbness; Moderate chest pains; Passed out in chair; Super dizzy; Suffocation in chest; Sick to their stomach; Heart racing immediately after vaccine administration; Fever; Had allergic reaction at the vaccine site; A spontaneous report was received from a consumer concerning a 61-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events suffocation in chest, super dizzy, moderate chest pains, sick to their stomach, heart racing immediately after vaccine administration, passed out in chair, fever, right hand feels tingly with numbness. The patient's medical history included COPD (chronic obstructive pulmonary disease), staph infection, CAD (coronary artery disease), depression, anxiety, shortness of breath and suffocation on chest. Concomitant medications reported were amoxicillin, gliclazide, acetylsalicylic acid, amlodipin, atorvastatin, clonazepam, hydroxyzine, multi vitamin, inhaler, albuterol as needed and nebulizer, all were used for an unknown indication. On 05 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 036A21A) Intramuscularly for prophylaxis of COVID-19 infection. On 05 Mar 2021, the patient had allergic reaction at the vaccine site, felt sick to their stomach, dizzy, heart racing immediately after inoculation with the vaccine. Pharmacist thought they were having a panic attack, but patient says no. That evening developed a fever. On 06 Mar 2021, the patient felt suffocation in chest that was tolerable. On 07 Mar 2021, the patient experienced bad suffocation in chest, super dizzy and passed out in chair. Stated that they were knocked out for 35 minutes. Suffocation decreased. On 14 Mar 2021, suffocation comes on with major chest pains. On 15 Mar 2021, the patient experienced the events moderate chest pains and right hand feels tingly with numbness. Treatment details included none. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, sick to their stomach and heart racing immediately after vaccine administration was resolved on 05 Mar 2021. The outcome of events, suffocation in chest and passed out in chair was resolved on 07 Mar 2021. The outcome of events, super dizzy, moderate chest pains, fever and right hand feels tingly with numbness was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (suffocation feeling, abdominal discomfort, pyrexia, tachycardia, and vaccination site reaction) a causal relationship cannot be excluded. Very limited information regarding the events (LOC, hypoaesthesia) has been provided at this time. Further information has been requested.
61 2021-03-23 palpitations, heart rate increased Approximately 3 hours after the injection, I felt dizzy and lightheaded. I went to bed but soon fel... Read more
Approximately 3 hours after the injection, I felt dizzy and lightheaded. I went to bed but soon felt my heart pounding. I got really cold and began to shake uncontrollably. My heart rate continued to accelerate and I thought it best to seek emergency medical help. I dialed 911, an ambulance was sent. EMTs determined that I should go to the hospital for monitoring. EMTs reported that my vital statistics were elevated. While at hospital, I was administered a saline IV and was kept there until my vital signs reached normal levels.
61 2021-03-24 arrhythmia I started to feel unwell soon after receiving the vaccination. I was tired and had a sore arm the f... Read more
I started to feel unwell soon after receiving the vaccination. I was tired and had a sore arm the first day. By the second day, I began having heart arrhythmia and shortness of breath, which was confirmed at my physician's office by EKG. I was referred to a cardiologist. Today (day three), I am still feeling less energetic and have a higher than usual amount of skipped beats. I get short of breath easily. This afternoon I have a bad headache. My cardiologist has ordered heart ultrasound and monitoring out of an abundance of caution. He says it could be that the inflammation from the vaccine might be causing heart irritation.
61 2021-03-25 heart rate increased, palpitations Chest pounding when trying to sleep. Pulse rate was 109 the next morning. Chills starting about... Read more
Chest pounding when trying to sleep. Pulse rate was 109 the next morning. Chills starting about 1:30 am and lasting until 3 am. Nauseous about 5 am.
61 2021-03-25 heart rate increased no symptoms after waiting 30 minutes, then mild fatigue 3 hours later then woke from sleep at 11pm... Read more
no symptoms after waiting 30 minutes, then mild fatigue 3 hours later then woke from sleep at 11pm with a rapid heart rate about 100/minute, widespread numbness and tingling around mouth, chin, arms and calves. called 911 BP was 135/77 98 pulox 68 pulse. Numerous episodes similar happened since usually at night. PCP advised allergist related to COVID reaction. ECHO,EKG were ok. adjusted meds to see if related and no change. also had very bloodshot eyes ,rash on legs and more need for Xopenex inhaler. Addressed with pulmonologist as well.
61 2021-03-25 fast heart rate Patient reported tachycardia at rest. called cardio. cardio recommended to go to ER. ER stabilized a... Read more
Patient reported tachycardia at rest. called cardio. cardio recommended to go to ER. ER stabilized and did observation. They could not find a reason for tachycardia. patient was discharged today after stabilized tachycardia
61 2021-03-26 heart rate increased 14 hours after receiving vaccine chills for 24 hours, fever low grade 12 hours, eyes burning, horri... Read more
14 hours after receiving vaccine chills for 24 hours, fever low grade 12 hours, eyes burning, horrible headache that just doesn't want to go away not even tylenol helped, nausea, fatigue, arm pain , arm pits swollen and hurt, heart rate elevated for 48 hours. The first shot I had all of this but didn't have headache. This second shot was much worse.
61 2021-03-28 chest pain Signed Pt here for her initial Covid 19 vaccine. Denies Hx of allergies to any component of the ... Read more
Signed Pt here for her initial Covid 19 vaccine. Denies Hx of allergies to any component of the Covid 19 vaccine, severe allergies to any vaccine or injectable or any Hx of severe allergic reaction to anything. Covid 19 vaccine given to left deltoid site. Pt tolerated well, but immediately after receiving the vaccine reported feeling dizziness. Pt was escorted to the sitting area, and reported feeling chest pain to left upper chest area. BP at 149/85, pulse rate at 62. No shortness of breath or facial swelling present. Due to reports of chest pain, dizziness and "feeling funny" pt was taken immediately to the ER per wheelchair.
61 2021-03-28 chest pain Saturday afternoon start to feel fatigue 8:00 pm 102.7 degrees (2 Tylenols) 9:00 pm 103.2 10:00 pm... Read more
Saturday afternoon start to feel fatigue 8:00 pm 102.7 degrees (2 Tylenols) 9:00 pm 103.2 10:00 pm 103.7 11:00pm 2 Tylenols 11:00 102. degrees Frim 8:00 - Monday 7:00 am; pain was immense; legs, arms, abdomen, jaw, neck and a headache to the moon and back. offset every 4 hrs Tylenols' Monday; continue pain on right side, left chest and headache; continue to us Tylenols' every 4 hrs.
61 2021-03-28 loss of consciousness passed out at home, diarrhea and nausea, and blood in stool this all
61 2021-03-28 palpitations Today is beginning of week 4. Multiple issues main ones were/are Burning/itching at site, Red warm t... Read more
Today is beginning of week 4. Multiple issues main ones were/are Burning/itching at site, Red warm to the touch, knot under injection site, Swollen lymph nodes under arm (still). 2nd day I was wheezing, freezing but no fever, exhausted, palpations. It got worse the 1st week then went away. 2nd week seemed to be all good. middle of the 3r week red again, pain lymph nodes enlaged etc
61 2021-03-29 chest discomfort Saturday 3/27/2021 -After waiting 15 minutes after the shot, my leg and arm affected with my MS beca... Read more
Saturday 3/27/2021 -After waiting 15 minutes after the shot, my leg and arm affected with my MS became heavy and not very responsive. This only lasted for 2-3 hours and I was able to walk and hold things. Sunday 3/28/2021 - I experienced pain in my joints and body most of the day. At about 5:00pm, I had chills, headache and extreme pain everywhere. I could no longer could use my leg and arm (MS limbs). My chest felt heavy and tight when breathing. I used Tylenol and Ibuprofen intermittently and drank lots of water. Slept most of the day. Monday 3/29/2021 Woke up with a headache, some pain in my joints and not able walk without difficulty until 2:30pm, after that time I was able to walk short distances slowly. Tuesday 3/30/2021 -At work, moving slow but feeling better.
61 2021-03-30 heart rate increased Shortness of breath Rapid heartbeat Fever Chills Body aches Stomach pain
61 2021-03-31 heart rate increased Increased Pulse rate - as high as 130bpm on occasion for 3 days. Doctor prescribed benadryl every 4... Read more
Increased Pulse rate - as high as 130bpm on occasion for 3 days. Doctor prescribed benadryl every 4 hours.. By the time I spoke with the doctor the occasional increase in pulse rate had stopped. She explained that this was not a common listed side effect for Moderna. I have since spoken to 3 other individuals who have had a similar reaction in a similar time span as well as one more person anectodately.
61 2021-03-31 hypertension, heart rate decreased First day around bedtime 11:00pm sever body ache especially upper middle back, hands and feet. Heart... Read more
First day around bedtime 11:00pm sever body ache especially upper middle back, hands and feet. Heart rate high 90's. Felt better next day. 2 days later body ache again day and night, middle upper back, feet and hand, under arms. Shortness of breath especially at bedtime, heart rate has been dropping from 80's to low 60's. blood pressure a little high 130's/80's. Feel lump in throat, like choking sensation on and off. Severe weakness-tiredness. I wake up light headed and shortness of breath in the morning. Big bruise on left leg 2 inch long by 1.2 wide. My oxygen usually is between 98-100, last night dropped to 94-95. Doctor told me to report reaction. Feel a bit better today. Took today 2 Advils.
61 2021-03-31 palpitations Palpitations after taking the Covid Vaccine. Vitals stable, no treatment required, cleared by EMS.
61 2021-03-31 palpitations Palpitations. Problem resolved, no further treatment required. Cleared by EMS
61 2021-04-01 chest pain Inection site pain muscle joint pain headache fatigue chills, fever pain when lifting arm chest pai... Read more
Inection site pain muscle joint pain headache fatigue chills, fever pain when lifting arm chest pain
61 2021-04-01 haemoglobin decreased Fingertip pain, with burning, throbbing and sensitivity. Skin turned red, had some edema, blisters ... Read more
Fingertip pain, with burning, throbbing and sensitivity. Skin turned red, had some edema, blisters developed, then the skin would split. Also tingling and throbbing sensation from the base of the skull down to the bottom of the spine. Also pain from the back of the neck radiating down to the shoulder blades. Symptoms began on 03/21/2021.
61 2021-04-01 pallor Patient reported an episode which she is classifying as a "petit mal seizure." She says she had swea... Read more
Patient reported an episode which she is classifying as a "petit mal seizure." She says she had sweating, chills, pallor and tremors throughout the body but did not lose consciousness, it lasted about 30 minutes in total.
61 2021-04-02 blood pressure increased Elevated heart rate Fever Rash Pain and swelling at injection site Seriously elevated blood pressure... Read more
Elevated heart rate Fever Rash Pain and swelling at injection site Seriously elevated blood pressure with pain in left arm and left side of body. Treated for allergic reaction at ER Given IV fluids, with medication to lower blood pressure, prednisone and benadryl. Given prescription for two days of prednisone upon release. Advised to not work for 2 days.
61 2021-04-02 chest discomfort 1:50 pm: chest pressure, a bit of breathing difficulty tingling in mouth and odd taste in mouth. T... Read more
1:50 pm: chest pressure, a bit of breathing difficulty tingling in mouth and odd taste in mouth. Tingling in mouth stopped within an hour or so. Chest issue and breathing problem lasted about 3-4 hours. Early evening, about 20 minutes of constant diarrhea. Late evening, inside bottom lip a bit swollen and outside bottom lip a bit itchy around the edges.
61 2021-04-02 loss of consciousness I was having the stated symptoms of fever (102); chills, fatigue starting the evening after receivi... Read more
I was having the stated symptoms of fever (102); chills, fatigue starting the evening after receiving the vaccine (3/26/21). Felt these symptons all day on 3/27/21. Got up to go to the bathroom at 3:00AM on 3/28. Started feeling weird while going to the bathroom. Finished and tried to make it back to bed but passed out before I could get to the bed. This woke my husband up and he wanted to get me up but I could not--too week Laid on floor for about 30 minutes before I felt strong enough to get up with assistance. Pregnancy History: 1 Child (9lbs. 1ox.) via C-Section
61 2021-04-03 heart rate increased 0940. Presented in the Observation area with complaints of a rapid heartbeat. Patient stated this ha... Read more
0940. Presented in the Observation area with complaints of a rapid heartbeat. Patient stated this has happened before and also with the first dose of the vaccination. Immediate evaluation by NP and clinic based EMS. 0942- 170/90; 78-20; 98% on RA. 0948- 158/90; 78; 98% RA. R. 20. Monitored during time of observation. No PVC; or PAC's. 10:02 Discharged home, stating she was feeling better.
61 2021-04-04 heart rate increased, blood pressure increased Lightheadedness, headaches, and tingling to Left side of face. 1400 V/s Bp 135/82, Pulse 79. A 61 ye... Read more
Lightheadedness, headaches, and tingling to Left side of face. 1400 V/s Bp 135/82, Pulse 79. A 61 year old white female received second moderna vaccine. Lot #022M20A to left deltoid. 1415pm patient c/o lightheadedness, headache, and tingling to L side of face. Patient states that she suffers with panic attacks. Observed patient for 30 mins. Re-assessed patient at 1425pm V/S Bp 1139/86 L deltoid pulse 80. Gave patient a bottle of water and encouraged to deep breathing. 1440 patient states she will be okay and she lives 2 minutes away from facility. Patient ambulatory and EM able to ambulate without any assistance. No other c/o voiced. Patient left facility at 1445pm.
61 2021-04-04 heart rate increased I thought it was part of the expected symptoms until a conversation with someone else that had these... Read more
I thought it was part of the expected symptoms until a conversation with someone else that had these symptoms noted that they were considered adverse: Received vaccine on a Saturday. As soon as I sat down after receiving the vaccine I felt dizzy, and shaky but wasn't shaking. continued throughout 15 minute wait time, and left stopped to get something to drink at a pharmacy, but still felt lightly dizzy and not stable, but was not having problems walking, did not stumble, etc. When I got home by heart was racing, this symptom lasted for a couple hours post vaccine. The other symptoms including diarrhea last from Saturday until late Sunday with most subsiding by Monday. A vaccine received years ago resulted in welts and hives upon the entire body that last several months. All of this information was shared at the clinic before receiving the vaccine stating it would be safe to receive. I am concerned about receiving the second dose.
61 2021-04-05 chest pain, palpitations Patient calling with complaint of vertigo, feeling off balance, and headache that began 24 hours aft... Read more
Patient calling with complaint of vertigo, feeling off balance, and headache that began 24 hours after receiving her first Moderna Covid vaccine. She had her first covid vaccine and says ever since she has been having balance issues. Last night she states she could hardly walk to the bathroom when she got up in the middle of the night, because she was so dizzy/room was spinning. She also says she has been experiencing heart palpitations. Patient has not had any known recent exposure to Covid, but did return approximately 1 month ago. Patient has history of hypertension, but has not had her blood pressure checked in a very long time (does not currently take any medications for hypertension- no PCP at this time). Patient states that the vertigo is happening on and off, but mostly when she is laying down in bed. Reports that she feels off balance when she first stands up to walk after laying down. Also reports that she is noticing heart palpitations on and off for the past 2 days. Patient has not had difficulty breathing, difficulty swallowing, facial swelling, rash, or chest pain.
61 2021-04-05 heart rate decreased heart rate and breathing slowed down, shaking, cold, random words, headache
61 2021-04-06 deep vein blood clot, pulmonary embolism Pt devolped cough and SOB arround time of vaccine found to have PE.
61 2021-04-07 blood pressure fluctuation, blood pressure increased, very slow heart rate, heart rate irregular Very dizzy; Blood pressure inreased to 190; Felt like she was dying; Heartbeat goes down, and goes u... Read more
Very dizzy; Blood pressure inreased to 190; Felt like she was dying; Heartbeat goes down, and goes up; Heartbeat dropped to 44; Suddenly her blood pressure goes down and up; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021. This spontaneous case was reported by a patient and describes the occurrence of BRADYCARDIA (Heartbeat dropped to 44) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for Hypertension, HYDROCHLOROTHIAZIDE for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Suddenly her blood pressure goes down and up). On 21-Mar-2021, the patient experienced BRADYCARDIA (Heartbeat dropped to 44) (seriousness criterion medically significant), DIZZINESS (Very dizzy), BLOOD PRESSURE INCREASED (Blood pressure inreased to 190), FEELING ABNORMAL (Felt like she was dying) and HEART RATE IRREGULAR (Heartbeat goes down, and goes up). The patient was treated with ATENOLOL (ATENOL) ongoing since an unknown date for Heart disorder, at a dose of 50 milligram. At the time of the report, BRADYCARDIA (Heartbeat dropped to 44), BLOOD PRESSURE FLUCTUATION (Suddenly her blood pressure goes down and up), DIZZINESS (Very dizzy), BLOOD PRESSURE INCREASED (Blood pressure inreased to 190), FEELING ABNORMAL (Felt like she was dying) and HEART RATE IRREGULAR (Heartbeat goes down, and goes up) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood pressure measurement: high (High) Reported as 190. On 21-Feb-2021, Heart rate: low (Low) 44. On 24-Mar-2021, Blood pressure measurement: high (High) 173/92. On 24-Mar-2021, Heart rate: normal (normal) 72. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient suffers from high blood pressure, takes medicines. Since the first dose of vaccine she felt a abrupt changes in her blood pressure and heartbeat. She doesn't know if this could be a side effect, she even thought she made a mistake and took 2 doses of her medication.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
61 2021-04-08 chest discomfort I have hx of episodes of sudden elevation of BP and pulse with accompanying other symptoms from poss... Read more
I have hx of episodes of sudden elevation of BP and pulse with accompanying other symptoms from possible adrenaline surges. When I sat down for my observation period, it felt like the start of one of those episodes except I had tingling in my hands which was different and a metallic taste in my mouth. Pulse and respirations were normal. Took many slow deep breaths to help calm the possible adrenaline surge I thought I was starting to experience. Felt ok by the time I was released from the 15 minute observation area. After driving about 5 minutes towards home, I started to get chest tightness and my throat felt strange and swallowing was not normal. I didn't feel well in general. No rash or hives. Breathing was ok. When I got home, I took 2 Benadryl. After two hours I felt much better except for the chest pain which felt like my "normal" atypical chest pain and lasted a little while longer. The chest tightness was gone though and the throat and swallowing had improved also.
61 2021-04-08 chest pain, chest discomfort most severe: -headache-sharp and painful off and on -very red hot face along with cold hands -sever ... Read more
most severe: -headache-sharp and painful off and on -very red hot face along with cold hands -sever joint pain in hips and knees -loss of feeling in my legs, tried to walk to the bathroom and had a hard time, looked down and my legs were not working right and they were crossed and i was loosing control of them -fever, chills -sharp chest pains -pressure in the chest -shoulder and across the back pain -exhaustion -trouble breathing -nausea -foggy thinking -swollen glands
61 2021-04-08 nosebleed Weakness Confusion Falling down Vision impairment Legs really weak All of the above symptoms start... Read more
Weakness Confusion Falling down Vision impairment Legs really weak All of the above symptoms started on March 14, 2021 On March 18,2021 she was not out of bed except for just a few minutes. On March 19, 2021 she was on the floor laying beside of the bed and my father noticed blood looking stuff on her shirt and bed covers. She was really confused and lethargic. She was really weak and could not stand. She was extremely fatigued. At around 10:30 she fell again on the floor and my father and sister in law was able to get her back up and put her in a chair and she went to sleep. At 12:55 my father noticed she was not breathing and called 911. When they did CPR blood was coming from her mouth and nose. When the ambulance arrived they immediately took her to the hospital where she was pronounced dead at around 3:30 pm.
61 2021-04-08 palpitations Patient presents to ED three days after receiving Moderna COVID-19 vaccine dose #1 at ER vaccien cli... Read more
Patient presents to ED three days after receiving Moderna COVID-19 vaccine dose #1 at ER vaccien clinic reporting palpitations and lightheadedness. ECG similar to prior ECG. No chest pain, diaphoresis, nausea, or exertional symptoms. Blood pressure 139/96 mmHg, other vital signs within normal ranges. Patient discharged to home stable with symptom improvement.
61 2021-04-08 fainting Woke up at 5am, walked to kitchen, started sweating and then fainted. Other symptoms include swollen... Read more
Woke up at 5am, walked to kitchen, started sweating and then fainted. Other symptoms include swollen red arm up to her neck, swollen glands, and hard to turn neck.
61 2021-04-09 chest pain Day 3: Soreness and itching at injection site - Benadryl Gel and Capaicin pain patch. Day 3 - week 7... Read more
Day 3: Soreness and itching at injection site - Benadryl Gel and Capaicin pain patch. Day 3 - week 7: itching at injection site - Benadryl Gel. Day 3 - week 7: weakness - rest in bed. Feverish feeling. Day 3: lots of mucous in throat and stomach caused burning in chest - Theraflu with Guaifenesin and Mucinex. Day 3 - week 6: lots of mucous in throat - Theraflu with Guaifenesin and Theraflu NiteTime and Mucinex and Zrytec 20mg tablets and Zrytec syrup 20ml. Cold symptoms which included chills. Weeks 5 & 6: chills then sweats. Week 7: Theraflu with Guaifenesin sometimes; Theraflu NiteTime sometimes; Zrytec 20mg tablets everyday. Feverish feeling, chills and sweats often.
61 2021-04-09 loss of consciousness Passed out; Arm is still sore; 102°F fever; This spontaneous case was reported by a health care pro... Read more
Passed out; Arm is still sore; 102°F fever; This spontaneous case was reported by a health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (COVID-19 in November.) in November 2020. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm is still sore) and PYREXIA (102°F fever). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), PAIN IN EXTREMITY (Arm is still sore) and PYREXIA (102°F fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Concomitant medications was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
61 2021-04-10 palpitations FEVER 100 DEGREES FOR 30 HOURS CHILLS BODY ACHES LOSS OF APPETITE RACING HEART WITH RESTING PULSE OF... Read more
FEVER 100 DEGREES FOR 30 HOURS CHILLS BODY ACHES LOSS OF APPETITE RACING HEART WITH RESTING PULSE OF 102 FOR 36 HOURS
61 2021-04-10 platelet count decreased, haemoglobin decreased, low blood platelet count, anaemia Severe acute immune thrombocytopenia, now refractory to steroids and IVIG developed 10 days after se... Read more
Severe acute immune thrombocytopenia, now refractory to steroids and IVIG developed 10 days after second dose of vaccine. Patient developed spontaneous wet purpura, petechiae and vaginal bleeding on 3/19/2021. CBC showed undetectable platelet count. Normal hemoglobin and platelets. Did not respond to dexamethasone 40md daily x 4 or multiple IVIG doses. Started romiplostim on 3/25/21 and is currently on dose escalations with platelets persisting undetectable. On 3/28 developed acute anemia with a 2 to 3 g/dL hemoglobin drop and was found to have a spontaneous hemoperitoneum . Treated with tranexamic acid, multiple platelet transfusions and an additional dose of romiplostim. Bleeding has since resolved but platelets remain undetectable.
61 2021-04-10 platelet count decreased Patient said she felt "bad" and went to the hospital and said the doctors told her that her platelet... Read more
Patient said she felt "bad" and went to the hospital and said the doctors told her that her platelets were too low and has been in hospital being treated for that.
61 2021-04-11 loss of consciousness After receiving her second dose of Moderna, member was standing in the locked bathroom stall and sta... Read more
After receiving her second dose of Moderna, member was standing in the locked bathroom stall and states her abdomen hurt severely due to her chronic IBS and she "collapsed from the pain," witnessed by another person in the bathroom who called for help. Patient was found on her back with her head next to the toilet and her right foot tucked backwards under her bottom.
61 2021-04-11 lightheadedness, chest pain, nosebleed, loss of consciousness, fainting 61 y.o. female who presents with chest pain and syncope. Patient reports she began feeling ill arou... Read more
61 y.o. female who presents with chest pain and syncope. Patient reports she began feeling ill around 6:00 p.m. last night. Patient reports she was having nausea, vomiting, and diarrhea. She denies any hematemesis or hematochezia. Patient states she awoke around 11:00 p.m. and felt like she was needing to vomit so she went to the bathroom. Patient reports that upon getting up she noticed pain across her chest. She described her pain as a midsternal pain with radiation across the chest. She described as a dull pressure. She currently reports no chest pain upon arrival to ER. Patient reports associated shortness of breath, lightheadedness, nausea, vomiting, and diaphoresis with the pain. Patient's cardiac risk factors include hypertension, smoking, age, obesity, and family history. Once patient was in to bathroom, she states she began having nausea, vomiting, and diarrhea. Patient subsequently passed out and hit her head on the bathtub. Patient had slight nose bleed. Patient's family found her lying in the floor and call 911. Patient was unsure of how long she was out during her syncopal episode. admitted to hospital Observation dx chst pain, vasovagal syncope
61 2021-04-12 cardiac arrest, cardio-respiratory arrest This is a 61 year old female, with history of hypertension, who presents to the ED via EMS for evalu... Read more
This is a 61 year old female, with history of hypertension, who presents to the ED via EMS for evaluation of cardiac arrest prior to arrival. Patient's husband came from anouther [sic] room and found patient take a big gasp then suddenly became unresponsive. EMS gave patient a total of 4 rounds of Epi, 1 Narcan, and 2 shocks en route. EMS reports with glucose level of 92. Unknown if patient is on any anticoagulation. Patient presents in asystole. Epi and bicarb given. Compressions performed. Lungs equal with bagging. Bedside US performed which did not reveal any meaningful cardiac activity. Code called. Discussed with family, they state she had been having some cardiac issues and her daughter died of cardiac problems in her 30s.
61 2021-04-12 cerebrovascular accident On the day after the vaccine, 4/8/21 I woke up and felt heaviness in both legs as I walked around my... Read more
On the day after the vaccine, 4/8/21 I woke up and felt heaviness in both legs as I walked around my home.That lasted for 2 days. on Saturday 4/10/21 those symptoms diminished slightly and I felt sleepy all day long. On Sunday 4/11/21 I woke up with numbness and heaviness on the entire left half of my body and was unable to walk properly. That evening I went to the Emergency Department. After review of CT and MR, I was diagnosed with having a stroke. I remained there for about 18 hours . My symptions decreased to tingling , so Iwas discharged, no treatment received. As of today, my sympttions are reduced almost amost 50% and i am able to walk with a walker..
61 2021-04-12 heart rate increased Tasted the vaccine in my mouth - 2 hours smelled the vaccine in my nasal passages - 2 hours Felt odd... Read more
Tasted the vaccine in my mouth - 2 hours smelled the vaccine in my nasal passages - 2 hours Felt odd just strange euphoric/weird - 6 hours Jitters - 2 days face felt swollen and puffy - 1 1/2 hours throat swelled but not closed I could still swallow but it was tight - 1 1/2 hours racing heartbeat - 3 hours off balance - vertigo - 6 hours
61 2021-04-12 palpitations, chest pain Patient developed chest pain, palpitations, SOB and "feeling like throat closing" approximately 10 m... Read more
Patient developed chest pain, palpitations, SOB and "feeling like throat closing" approximately 10 minutes after receiving vaccine. Hx of anaphylaxis from penicillin and cipro. Pt was given oxygen via non rebreather mask, Epipen and transported to ED via paramedics.
61 2021-04-12 fainting Fainted and fell face first on my kitchen floor out for about 2 minutes. Bruised face.
61 2021-04-13 chest discomfort Metallic taste , cold sensation. 5 mins later tongue and throat swelling, face and chest hot and ti... Read more
Metallic taste , cold sensation. 5 mins later tongue and throat swelling, face and chest hot and tingling, shortness of breath
61 2021-04-13 hypertension THE HD WAS DOING A POP UP VACCINE CLINIC AT CHURCH. DURING THIS CLINIC, THIS PT WAITED FOR HER 15 MI... Read more
THE HD WAS DOING A POP UP VACCINE CLINIC AT CHURCH. DURING THIS CLINIC, THIS PT WAITED FOR HER 15 MINUTES POST VACCINATION. WHEN HER TIME WAS UP SHE GOT UP AND CAME TO ME AND SAID "I DON'T FEEL RIGHT. I FEEL STRANGE" I SAT HER DOWN BESIDE ME AND STARTED QUESTIONING WHAT WAS GOING ON. SHE STATED THAT SHE HAS A SEVERE SHARP ABDOMINAL PAIN THAT FEELS LIKE SOMEONE IS STABBING HER WITH A KNIFE. SHE ALSO C/O NUMBNESS/TINGLING IN HER LEFT ARM, WHICH IS OPPOSITE THE SITE SHE WAS VACCINATED, AND THAT HER THUMB ON THE LEFT SIDE IS COMPLETELY NUMB. OFFERED PT WATER AND IMMEDIATELY BEGAN TAKING BP AND VITALS EVERY 5-10 MINUTES. FIRST BP READING AT 11:10 WAS 160/110. PT STATED THIS IS ABNORMALLY HIGH EVEN WITH HER HISTORY OF HTN. HR WAS 110. O2 95-98% WITH FINGER PULSE OX. PT ALSO STATED HER BP TENDS TO "RUN 20 OFF FROM OPPOSITE ARM AND ALL DOCTORS HAVE TO TAKE BOTH ARMS" SO WE BEGAN CHECKING BOTH ARMS WITH ALL BP CHECKS. PT WAS ALERT AND ORIENTED X 4, ACTIVE. SKIN WPD. RESP EVEN AND UNLABORED. CAP REFILL LESS THAN 3 SECONDS. WN, AND WD. AT 11:15 BP IN L ARM 130/90 AND R ARM 140/90. AT 11:23 O2 97% HR 92 BP R ARM 122/78, L ARM 120/80. 11:35 R ARM 126/88. 11:45 R ARM 124/90 AND L ARM 128/88. PT STATES THESE BP READINGS ARE MUCH MORE NORMAL FOR HER. PT STATED SHE FELT VERY FATIGUED AND TIRED BUT SHE BELIEVES THAT COULD BE HER ALLERGY MEDICINE. SHE WAS OFFERED AN AMBULANCE AND SHE DECLINED. SHE STATED SHE WOULD CALL HER PCP WHO IS DR. WHEN SHE GETS HOME. PT STATED SHE WAS VERY NERVOUS ABOUT GETTING VACCINE AND THINKS MAYBE IT COULD BE NERVES. DENIES ANY PAST PROBLEMS WITH ANY OTHER VACCINES OR INJECTABLES JUST STATED THAT SHE TENDS TO BE VERY SENSITIVE TO SOME MEDICATIONS AND THERE ARE CERTAIN THINGS SHE CANT TAKE NOT BECAUSE OF AN ALLERGY, BUT BECAUSE SHE IS JUST SENSITIVE TO THOSE THINGS. PT WAITED AN ADDITIONAL 30 MINUTES AFTER HER INITIAL 15 MINUTE WAIT TIME AND BECUASE SHE WAS FEELING MUCH BETTER, AND STATED HER ABDOMINAL PAIN HAD SUBSIDED AS HAD THE NUMBNESS AND TINGLING IN HER ARM SHE WAS FINE TO GO HOME. SHE LIVES JUST ACROSS THE STREET AND HER HUSBAND IS CURRENTLY AT HOME WHO SHE IS TAKING TO THE DOCTOR IN JUST A COUPLE OF HOURS. REMINDED PT TO CALL HER OWN DOCTOR WHEN SHE GOT HOME AND TOLD HER I WOULD CALL HER THE NEXT DAY TO CHECK UP ON HER. TC TO HER ON 4/14/21 @1000. PT STATES SHE IS FEELING MUCH BETTER THAN YESTERDAY AND THAT SHE IS FINE TODAY.
61 2021-04-13 fainting, pallor Pt told vaccinator vasovagal reaction prior with flu vaccine. Rec'd vaccine lying down due to past ... Read more
Pt told vaccinator vasovagal reaction prior with flu vaccine. Rec'd vaccine lying down due to past vasovagal episode after flu vaccine 5yrs ago. Within 30 seconds pt complained of dizziness, feeling flushed, warm, became pale and diaphoretic. Elevated legs above heart, provided. ice pack to back of neck. VS taken BP 164/90, hr 82 reg strong, resps 14 reg, non-labored, Sp02 98% RA. Provided reassurance. Approx 15 minutes after vaccine given pt stated I feel better, sat her up on cot then moved to recovery area seating. provided water for hydration. Pallor and diaphoresis subsided. Ok'd to exit after 30 min encouraged to sign onto V-safe website. RN
61 2021-04-13 fainting Pneumonia; Fainting; Vomiting; Fever; Muscle aches and pains; This spontaneous case was reported by ... Read more
Pneumonia; Fainting; Vomiting; Fever; Muscle aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and SYNCOPE (Fainting) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), VOMITING (Vomiting), PYREXIA (Fever) and MYALGIA (Muscle aches and pains). On 23-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). On 18-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, PNEUMONIA (Pneumonia) had not resolved and SYNCOPE (Fainting), VOMITING (Vomiting) and MYALGIA (Muscle aches and pains) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Chest X-ray: revealed pneumonia (Inconclusive) Revealed pneumonia. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
61 2021-04-14 blood glucose increased Nose sores and raw tongue. Fever 101.6 Chills, Swelling, High Blood Sugar 442 constipation, blurred... Read more
Nose sores and raw tongue. Fever 101.6 Chills, Swelling, High Blood Sugar 442 constipation, blurred vision, very weak. My husband had to guide me to restroom and back to bed. These were the only times I was up and mobile. Muscle and joint pain
61 2021-04-14 cerebrovascular accident On April 10, 2021, patient reported losing vision in right eye. Saw primary physician on 4/14/2021 a... Read more
On April 10, 2021, patient reported losing vision in right eye. Saw primary physician on 4/14/2021 and had ultrasound of the neck done on 4/14/2021. Patient reported per phone on 4/15/2021 that she was told that she had a stroke in her right eye. Was placed on ASA 325mg and Clotidogrel 75mg.
61 2021-04-14 chest discomfort 8:48 AM- Patient complains of dizziness/chest tightness and SOB after second dose of moderna covid v... Read more
8:48 AM- Patient complains of dizziness/chest tightness and SOB after second dose of moderna covid vaccine. States she experiences SOB sometimes but this time feels different. States she takes BP medication and has a hx of high bp. Denies throat swelling, assessed and all appeared normal. Vital signs at 8:51 AM- 118/88, 98%, 60. Assisted patient and husband to private room and assessed stomach, back and arm for rash and/or hives; none apparent. Patient states she is feeling better and not having difficulty breathing. Vital signs at 9:00 AM- 108/82, 96%, 58. Assessed throat for swelling, none apparent. Vital signs at 0905- 118/79, 98%, 60. Patient states she is feeling completely better and sob and chest tightness went away. Also had patient walk in hallway and states she is no longer dizzy. Advised patient and husband that all vital signs are normal and no other apparent signs of anaphylaxis, however if she still felt dizzy or any other symptoms she could stay as long as needed. Patient denies having any remaining symptoms and states she is ready to go home. Advised patient that if she experienced any other symptoms after leaving clinic such as sob, chest pain, rash/hives to contact emergency services. Patient and husband verbalize understanding. RN
61 2021-04-14 chest pain Patient called 4/15/2021, states had first dose 3/17/2021 and approximately 1 hour after injection d... Read more
Patient called 4/15/2021, states had first dose 3/17/2021 and approximately 1 hour after injection developed chest pain, had extreme sweating, became short of breath and experienced nausea. States went to bed and continued with these symptoms for 36 hours. Took nitroglycerin to relieve chest pain. Saw heart doctor today who told her to call us to report adverse reaction and advised to not take second dose.
61 2021-04-14 chest pain Felt like I had Covid19 all over again. 30 hours of misery! Bad body aches, chills all night, linin... Read more
Felt like I had Covid19 all over again. 30 hours of misery! Bad body aches, chills all night, lining of skull and back of neck going into the head felt warm, feverish. Inner ear ached, back of eyeballs ached, joints ached badly. Tylenol lessened the pain somewhat, but didn't get rid of it. Had sharp pain in heart during the night. No position in bed helped, neither did walking around until I went back to bed and laid down on my stomach. Pain then subsided and didn't come back. Was headachy for 3 days after the injection.
61 2021-04-14 palpitations, blood clot on Saturday, March 27th, patient noticed swelling in left lower leg with Shortness of breath, and he... Read more
on Saturday, March 27th, patient noticed swelling in left lower leg with Shortness of breath, and heart racing. on 3/39, the patient presented to the ED and was admitted and diagnosed with a blood clot from left groin to left ankle, with "clot in heart and lungs". heparinized and discharged home on Coumadin currently taking 5 mg on Sunday, Monday, Wednesday, and Saturday and 2.5 mg on Tuesday and Friday each week.
61 2021-04-14 palpitations had fever 102.5 for almost 48 hrs Headache, Nauseous, chills that made me shake uncontrollable, w... Read more
had fever 102.5 for almost 48 hrs Headache, Nauseous, chills that made me shake uncontrollable, weakness, Dizziness, the fever is gone but still experiencing Dizziness, weakness, Headache, nauseous, confusion at night sweats racing hart
61 2021-04-14 palpitations Pt developed palpitations, and felt like her legs were cold and tingling. BP 110/60, HR 65, SP02 99%... Read more
Pt developed palpitations, and felt like her legs were cold and tingling. BP 110/60, HR 65, SP02 99%. She later admitted that it felt like she was having a panic attack. She improved with observation only. Her family member drove her home. She declined EMS services/911.
61 2021-04-14 fainting Fainted after rising from recumbent position with resultant facial injuries and broken teeth
61 2021-04-15 chest discomfort Throat swelling, hoarse voice, chest tightness and red rash. Allergic reaction.
61 2021-04-15 chest discomfort About 9 hours after receiving 2nd dose of vaccine, patient awoke with quite significant itching (vac... Read more
About 9 hours after receiving 2nd dose of vaccine, patient awoke with quite significant itching (vaccine site as well head, neck, scalp, ears, trunk, arms, palms, and legs) , swelling around eyes (almost swollen shut), and tightness in chest. After 1st dose of vaccine, she had mild swelling around eyes and a little tightness in chest that she thought was related to pollen.
61 2021-04-15 hypotension, very slow heart rate Dizziness, Lightheadedness, Numbness, Sweating, hypotension, bradycardia Awake/alert/oriented observ... Read more
Dizziness, Lightheadedness, Numbness, Sweating, hypotension, bradycardia Awake/alert/oriented observation, water, apple juice, recumbent transfer to ED
61 2021-04-15 pallor Patient reported complaints of feeling pale and nauseated following vaccination around 10 mins post ... Read more
Patient reported complaints of feeling pale and nauseated following vaccination around 10 mins post vaccination. BP 120/73, Unable to obtain HR and O2 Sat with oximeter due to circulation problems Patient given 8 oz OJ, crackers, and nut bar resolving current complaints stated above. No other complications and left site with resolution
61 2021-04-16 chest pain Exhaustion Severe muscle fatigue & soreness (day after) Joint pain (day after) Nausea, vomiting (day... Read more
Exhaustion Severe muscle fatigue & soreness (day after) Joint pain (day after) Nausea, vomiting (day after) Random chest pain jabs Severe head ache (for 3 days now)
61 2021-04-16 heart rate increased Upon working out, my heart rate went to 195 bpm. After workout, it slowly went down to 135 bpm and ... Read more
Upon working out, my heart rate went to 195 bpm. After workout, it slowly went down to 135 bpm and then to 110-120 bpm and remained at this for the remainder of the day. My heart rate was measured via my smart Watch.
61 2021-04-17 chest discomfort C/o tightness in chest, slight diff. Breathing. VSS. ABLE TO SPEAK . Code Green called, paramedics o... Read more
C/o tightness in chest, slight diff. Breathing. VSS. ABLE TO SPEAK . Code Green called, paramedics on site to assess. feels better after 15min.
61 2021-04-17 chest pain Patient had prior positive test for Covid-19 September 1st, 2020 Headaches & Fatigue for 3 months D... Read more
Patient had prior positive test for Covid-19 September 1st, 2020 Headaches & Fatigue for 3 months Dose #1: Patient self reports: Mild Sore arm at site, Nausea & Headache - 1st night Mild Sore arm at site, nausea, headache, jount aches, fatigue, shortness of breath, chills - Day 2 Moderate Sore arm at site, nausea, headache, joint aches, fatigue, chills, fever, depression - Day 3 Moderate Fatigue, Depression, Irritability, right eye pain & redness - Day 4 Moderate Fatigue, Irritability, right eye pain & redness - Day 5 Moderate Fatigue, Irritability, right eye pain & redness - Day 6 to Day 14 Mild Fatigue, Irritability, right eye redness persists (only eye pain subsided day 20, (+L-Lysine supplement) Item #22
61 2021-04-17 palpitations, fainting Aprox 8 minuted after receiving the vaccine, I noticed prickling (pins and needles) starting to occu... Read more
Aprox 8 minuted after receiving the vaccine, I noticed prickling (pins and needles) starting to occur on my forehead, then including the nose as well. I felt numbness at the tip of my nose. I took my glasses off and my vision was blurry. I felt weak (almost faint), I felt a chill running through my arms and lightheaded. I was able to get the attention of the person monitoring us in the 15 minute wait area and she took me to the side to a nurse and EMS person was stated. I felt almost that feeling when they start an IV up (that weakness). My blood pressure remained relatively constant the times they checked it though I did feel a racing heart at moments. In about 30 minutes the obvious pins and needles was starting
61 2021-04-17 palpitations Nausea, horrible headache, chills, weakness turning to severe weakness, shortness of breath, fatigue... Read more
Nausea, horrible headache, chills, weakness turning to severe weakness, shortness of breath, fatigue, heart beating very hard. Today is 3rd day of symptoms. Still experiencing fatigue, headache, fatigue.
61 2021-04-17 fainting, chest pain Fainted on day 2. Woke up with a bruise under eye. Extreme pain in entire chest, shoulders. No heada... Read more
Fainted on day 2. Woke up with a bruise under eye. Extreme pain in entire chest, shoulders. No headaches, no fever. Did not injure myself during fainting spell. Pain in chest and arms, occasional chills continued for 2 weeks solid. I needed to take pain relief round the clock. Pain when sneezing or coughing, continuing for 2 weeks. Prior to the 2nd shot, I would describe myself as in very good condition. After, very weak physical condition. I feel like I need to recover from this shot.
61 2021-04-19 very slow heart rate, chest discomfort Patient called nurse triage line to report the following symptoms: Intermittent chest pressure, sym... Read more
Patient called nurse triage line to report the following symptoms: Intermittent chest pressure, symptomatic bradycardia, shortness of breath, dizziness, headache, body aches.
61 2021-04-19 chest discomfort, chest pain, fast heart rate Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Fatigue-Severe, Systemic: Hypertensio... Read more
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Fatigue-Severe, Systemic: Hypertension-Severe, Systemic: Nausea-Severe, Systemic: Tachycardia-Severe
61 2021-04-19 heart rate increased Within minutes of vaccine, slight taste in mouth, otherwise only a slightly sore arm and no appetite... Read more
Within minutes of vaccine, slight taste in mouth, otherwise only a slightly sore arm and no appetite. Within 12 hours, sharp pain in both knees, right ankle, right wrist; throbbing right arm, dizzy/vertigo, very rapid heartbeat. Within 24 hours, bedridden with low grade fever, continued dizziness, very rapid heartbeat, headache, but no joint pain. Within 36 hours, still rapid heartbeat with erratic pulse at times, and no appetite. Within 48 hours, heart rate beginning to slow somewhat, increasing with exertion. By 72 hours, heart rate finally back to pre-vaccine rate. Six days after injection, dizziness returns. On seventh day, dizziness is gone but still no appetite. Funny taste persists. Anticipate post-vaccine issues to continue until day 10, same as first dose.
61 2021-04-19 heart rate irregular Within minutes, flush down the body. Then a very funny taste in my mouth (lasting several days). Wit... Read more
Within minutes, flush down the body. Then a very funny taste in my mouth (lasting several days). Within a few more minutes, rapid heartbeat with some intermittent skipping (lasted for 4 hours). Complete loss of appetite (lasted for several days). Couldn't lift left for two days. During the week from time of injection, one day of fatigue.
61 2021-04-20 cardiac arrest Day 2 : fever chills and flu like symptoms Day 5 : full cardiac arrest: with no previous heart issue
61 2021-04-20 cardio-respiratory arrest Resident was found kneeling over walker with face down in the bathtub right before 1700. Code calle... Read more
Resident was found kneeling over walker with face down in the bathtub right before 1700. Code called and initiated. Resident pronounced dead at 1721 by EMS.
61 2021-04-20 chest discomfort Breathkess. Cant get a deep breath heavy chest laying down
61 2021-04-20 chest discomfort Patient had fever, chills, body aches and fatigue the next day. Sunday she felt better. Monday she... Read more
Patient had fever, chills, body aches and fatigue the next day. Sunday she felt better. Monday she had fever, chills, congestion, dry cough. Tuesday she also had diarrhea, decreased appetite, loss of smell and taste and headache. She is having pressure in her chest with taking deep breaths.
61 2021-04-20 nosebleed Symptoms started most significantly about 26 hours after receiving vaccine. Symptoms included: feve... Read more
Symptoms started most significantly about 26 hours after receiving vaccine. Symptoms included: fever (100+, even after several doses of Tylenol); headache; chills; body aches - especially left side of neck and left shoulder (vaccine was administered in left arm) - back ached and legs did too; bloody nose; redness, soreness and 'goose egg' at injection site; fatigue.
61 2021-04-20 loss of consciousness Woke up with body aches and sweating. Stomach and lower back was hurting extremely where I couldn?t... Read more
Woke up with body aches and sweating. Stomach and lower back was hurting extremely where I couldn?t stand, Could not get out of bed till after noon. Went to sit for lunch and got faint. Passed out but was slurring, drooling and couldn?t even open my eyes for over 10 minutes. My daughter called 911. I was still unconscious when EMT got there. They checked vitals and I slowly stabilized. Still have a lot of weakness and stomach ache
61 2021-04-20 palpitations Within 5-7 minutes after injection, throat started to close up and heart started to race (elevated f... Read more
Within 5-7 minutes after injection, throat started to close up and heart started to race (elevated from upper 60?s to about 135-140 - checked on Apple Watch). Having reaction Reported to pharmacist who offered ambulance and inquired if I was anxious (wasn?t until my throat started to close). It didn?t close further but stayed very scratchy and uncomfortable, HR remained elevated 90?s ish). Finally one hour after shot, I purchased and took a dose of Benadryl which helped; at 530 PM took another dose of Benadryl as throat became increasingly scratchy /uncomfortable which again helped. Woke at 230 am finally feeling that reaction had passed. Pharmacist encouraged returning for next shot despite reaction. I participated in V-safe and reported reaction same day as vaccine. Researched on own to try and figure out 2nd dose or no as did not feel pharmacy was equipped for anaphylaxis. Finally called and spoke with Moderna on 4/5/21 and they indicated this was definitely an acute allergic reaction and should be reported to VAERS and 2nd dose was contraindicated Spoke with pharmacist on 4/6 (date scheduled for 2nd dose - my husband was getting his 2nd dose) and she did not discourage 2nd dose but I elected to follow up with my allergy testing as recommended by CDC which is now pending
61 2021-04-20 pulmonary embolism Patient developed bilateral PE
61 2021-04-21 pulmonary embolism Pain started on the upper thigh in left leg, caused staying in bed for three days. Tried to stretch ... Read more
Pain started on the upper thigh in left leg, caused staying in bed for three days. Tried to stretch out the legs, but had pain every time. ON 4/11/21 had difficulty breathing, so called 911 and was taken to the ER. Diagnosed with pulmonary embolism/
61 2021-04-22 loss of consciousness She also passed out going to the bathroom twice.; Felt hot; Clammy; Feels very weak; Pain in left ar... Read more
She also passed out going to the bathroom twice.; Felt hot; Clammy; Feels very weak; Pain in left arm,; Difficulty moving left arm; Fever; chills; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She also passed out going to the bathroom twice.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (She also passed out going to the bathroom twice.) (seriousness criterion medically significant), FEELING HOT (Felt hot), COLD SWEAT (Clammy), ASTHENIA (Feels very weak), PAIN IN EXTREMITY (Pain in left arm,), MOBILITY DECREASED (Difficulty moving left arm), PYREXIA (Fever), CHILLS (chills) and NAUSEA (Nauseous). At the time of the report, LOSS OF CONSCIOUSNESS (She also passed out going to the bathroom twice.), FEELING HOT (Felt hot), COLD SWEAT (Clammy), ASTHENIA (Feels very weak), PAIN IN EXTREMITY (Pain in left arm,), MOBILITY DECREASED (Difficulty moving left arm), PYREXIA (Fever), CHILLS (chills) and NAUSEA (Nauseous) outcome was unknown. Treatment medication included acetaminophen. Action taken with m-RNA1273 in response to events is consider as not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
61 2021-04-22 loss of consciousness flu like symptoms loss of consciousness next day
61 2021-04-22 fainting, hypotension Headache, chills, shaking, nausea, vomiting, diarrhea, lightheadedness, through 4/16/2021. Low BP, L... Read more
Headache, chills, shaking, nausea, vomiting, diarrhea, lightheadedness, through 4/16/2021. Low BP, Lightheadedness, diarrhea, fainting. Till 4/22/2021. Still have light headedness as of today.
61 2021-04-22 fainting I had extreme dizziness and fainted and fell in the bathroom after getting up the morning after my v... Read more
I had extreme dizziness and fainted and fell in the bathroom after getting up the morning after my vaccine. I continued to be dizzy throughout the 2nd day post shot. The second day I also had two episodes of vomiting. These were in addition to the more common symptoms I had of mild fever, severe headache, body aches, injection site pain, chills, nausea, fatigue and loss of appetite, which persisted into the 3rd day.
61 2021-04-23 cerebrovascular accident Stroke; More than 36 days have passed since first dose, still didn't get second dose; This spontaneo... Read more
Stroke; More than 36 days have passed since first dose, still didn't get second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included AMLODIPINE, ENALAPRIL and METOPROLOL TARTRATE for Blood pressure abnormal, ATORVASTATIN and EZETIMIBE for Cholesterol total abnormal NOS, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have passed since first dose, still didn't get second dose). The patient was hospitalized from 29-Mar-2021 to 15-Apr-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days have passed since first dose, still didn't get second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's past medical history of Hypertension, cholesterol. may remain risk factor for this event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's past medical history of Hypertension, cholesterol. may remain risk factor for this event.
61 2021-04-23 chest pain server arm pain in both Armes both hips pain cold chest. Cough chills. Pain in arms and hips subsid... Read more
server arm pain in both Armes both hips pain cold chest. Cough chills. Pain in arms and hips subsidie the next day about 11:00 am . but cold like system still. Here. Taking over the counter med.Running nose.
61 2021-04-23 deep vein blood clot, pulmonary embolism Bilateral pulmonary embolism; DVT; This spontaneous case was reported by a consumer (subsequently me... Read more
Bilateral pulmonary embolism; DVT; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Bilateral pulmonary embolism) and DEEP VEIN THROMBOSIS (DVT) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Bilateral pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (DVT) (seriousness criterion hospitalization). At the time of the report, PULMONARY EMBOLISM (Bilateral pulmonary embolism) and DEEP VEIN THROMBOSIS (DVT) outcome was unknown. The HCP got the vaccine several weeks after quarantine after that. After her second dose, she had a clotting issue which she had never had before. She experienced bilateral pulmonary embolism and DVT and was in the ICU twice. Action taken with the mRNA 1273 in response to the events was not applicable as the patient completed both the doses. Reporter did not provide the causality. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
61 2021-04-23 deep vein blood clot, pulmonary embolism Deep vein thrombosis; Pulmonary embolism; Shortness of breath; This spontaneous case was reported by... Read more
Deep vein thrombosis; Pulmonary embolism; Shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 03-Jan-2021. Concomitant products included PARACETAMOL (TYLENOL), MAGNESIUM and VITAMIN B3 for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion hospitalization) and PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). The patient was hospitalized for 2 days due to DEEP VEIN THROMBOSIS and PULMONARY EMBOLISM. At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown and DYSPNOEA (Shortness of breath) had not resolved. Not Provided The patient received Xarelto and IV blood thinner at hospital. Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. This case was linked to MOD-2021-083811 (Patient Link).; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded
61 2021-04-24 low blood platelet count Longstanding chronic ITP with platelet counts 40-50,000 since 2016. Platelet count was found to be ... Read more
Longstanding chronic ITP with platelet counts 40-50,000 since 2016. Platelet count was found to be 11,000 on 3/9/21 when it happened to be checked 6 days after her immunization. Previous value 39,000 12/3/20 which was her stable number. Plts rechecked over next 3 days and stayed 11,000. Given 2 doses of IVIG (500 mg/kg) and plts rose to 227,000 over the next week then fell to her 68,000 on 3/30/21 prior to her 2nd dose of Moderna. Fell to 38,000 the following day then rose to 49,000 the following week. Remained asymptomatic the entire time.
61 2021-04-26 cardiac arrest could not breath; in induced coma; went into cardiac arrest; This spontaneous case was reported by a... Read more
could not breath; in induced coma; went into cardiac arrest; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COMA (in induced coma), CARDIAC ARREST (went into cardiac arrest) and DYSPNOEA (could not breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043021A and 037A21B) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced COMA (in induced coma) (seriousness criterion hospitalization) and CARDIAC ARREST (went into cardiac arrest) (seriousness criterion hospitalization). On 19-Apr-2021 at 1:00 AM, the patient experienced DYSPNOEA (could not breath) (seriousness criterion hospitalization). The patient was hospitalized on 19-Apr-2020 due to COMA, then on 19-Apr-2021 due to CARDIAC ARREST and DYSPNOEA. The patient was treated with Manual therapy (CPR) for Cardiac arrest and Manual therapy (CPR) for Dyspnoea. At the time of the report, COMA (in induced coma), CARDIAC ARREST (went into cardiac arrest) and DYSPNOEA (could not breath) outcome was unknown. No concomitant medications were reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
61 2021-04-26 cardio-respiratory arrest, fibrin d dimer increased Pt came in with positive D-dimer, coded and passed
61 2021-04-26 chest pain WITHIN ONE MINUTE, PT EXPERIENCED NAUSEA, BURNING IN THE CHEST AND THROAT AND A BAD TASTE IN HER MOU... Read more
WITHIN ONE MINUTE, PT EXPERIENCED NAUSEA, BURNING IN THE CHEST AND THROAT AND A BAD TASTE IN HER MOUTH. THE PHARMACIST ON DUTY TEST HER BLOOD PRESSURE AND IT WAS 198-90. HER SON CAME TO PICK HER UP AND HE CALLED AN AMBULANCE. THE EMT TOLD HER TAKE IT EASY BUT DID NOT ADVISE GOING TO THE HOSPITAL. HER BP CONTINUED TO BE HIGH AND HER DOCTOR HAS HER SCHEDULED FOR APPOINTMENTS EVERY 3 DAYS TO KEEP AN EYE ON HER. SHE IS WAITING FOR EKG RESULTS AND HER BP HAS COME DOWN BUT IS NOT BACK TO NORMAL AS OF 4-21-21.
61 2021-04-26 hypertension 10 minutes after receiving my 2nd shot I felt a hot within my entire body and also felt similar to g... Read more
10 minutes after receiving my 2nd shot I felt a hot within my entire body and also felt similar to going under anesthesia. I was taken to another area. My BP was extremely high 220/??. (I remembered my sister in law who mentioned to hydrate). I keep drinking water (about 4 bottles in an hr). After about 15 mins, kept walking. It took about 1 1/2 hours for BP to drop to 165/90. I was asked how was I feeling. I was feeling better and I was sent home. Today (4/27/21, I went to the dentist an had a similar event. the ambulance was called - they told me to go home and visit my doctor. My doctor asked that I come in on Thursday 4/29/21. BP came back down2 hrs ago but felt woozy a few mins ago, checked at it is at 1176/101. Waiting to hear from her if I should take another Losartan tablet.
61 2021-04-26 palpitations Covid19 vaccine: vaccination today, pt was getting second dose of moderna when 10 minutes later she ... Read more
Covid19 vaccine: vaccination today, pt was getting second dose of moderna when 10 minutes later she started experiencing palpitations, flushed face, lip swelling, lightheadedness. No respiratory distress. Pt given benadryl by medics. Pt had history of anaphylaxis to cat dander. Given epi in ED. Stable after 3h ED obs. Rpt VS without tachycardia/hypertension despite epi. DC with return precautions.
61 2021-04-27 deep vein blood clot, cerebrovascular accident, pulmonary embolism DVT in right leg; pulmonary emboli and a stroke on 4/2/2021
61 2021-04-27 fainting About 3 minutes after leaving the drive-through vaccine center (following the 15 minute wait period ... Read more
About 3 minutes after leaving the drive-through vaccine center (following the 15 minute wait period during which I felt fine), while driving home, I felt dizzy, ears ringing, and light-headed and it kept increasing. Luckily, I pulled into a parking lot, called 911, and fainted. I regained awareness after a couple of minutes with a fire truck arriving, but was foggy and sweating. I recovered after several minutes and did not get transported anywhere. Firemen advised me to drink lots of water. I felt very tired but otherwise OK by about 35 minutes after the shot.
61 2021-04-29 chest pain, bleeding on surface of brain "Moderna COVID-19 Vaccine EUA" -- received 1st dose 3/27/2021 Received 1st Moderna vaccine in R arm ... Read more
"Moderna COVID-19 Vaccine EUA" -- received 1st dose 3/27/2021 Received 1st Moderna vaccine in R arm on 3/27/21. Within first hour, she had a headache, R eye pain, and felt tired; symptoms subsided after she laid down. On 3/31 in early AM, felt sudden and more severe headache and same eye pain, and "electrical contractions down neck, back, and spine." Went to medical facility, then transferred to hospital, and transferred to another hospital via helicopter. 61-year-old female, generally very healthy, on no medications, here complaining of sudden onset right sided stabbing/electrical headache which began 30 minutes prior to arrival. She states she was standing at work when had sudden onset severe headache radiating into her right eye. Stating that it feels like my right eyeball is going to explode. She ranks the pain a 9 out of 10. She does have a history of migraine headaches which have never been evaluated with imaging or by neurology. They were normally frontal, and she has not had one in more than 2 years. She states that this headache is dramatically different than her prior migraines. Patient states associated with this sudden onset headache, she had bilateral neck pain, and substernal chest pain. Upon arrival to clinic, she points to her substernal region as the site of her chest pain. She denies associated shortness of breath, irregular heart rate/rhythm, presyncope. She does feel slightly weak. Of note, patient states she had a MODERNA COVID-19 vaccine on Saturday and subsequently had some right-sided shoulder pain. Her symptoms are on the same side. - 7:50 AM: BP 165/109 (R arm); pulse 86; no antihypertensives given, given a total of 100 mcg fentanyl over 1 hr - 9:04 AM: BP 150/92 (R arm); pulse 60; transferred to hospital and then to transfered to another hospital via helicopter for SAH 3/31/2021 ED - given nicardipine IV, dexamethasone IV, levetiracetam, and antiemetics. Nero noted that no associated trauma, LOC, or seizure with the HA, Neuro assessment - day 4 (plus possible re-rupture within last 24 hours) of good clinical grade HH2 low volume aSAH due to ruptured R ICA ANR 4/1/2021 - completed successful and uncomplicated RICA oblong aneurysm coiling (successful coil elimination & preservation adjacent PcommA infundibulum). Patient was admitted to critical care for post procedure care, monitoring, and management of sodium, blood pressure, and headache. Levetiracetam discontinued since patient did not have any seizures. 4/7/2021 - discharged
61 2021-04-29 palpitations Moderna COVID-19 Vaccine EUA approx. 1 AM: felt fast heartbeat and extreme aches and pain all over b... Read more
Moderna COVID-19 Vaccine EUA approx. 1 AM: felt fast heartbeat and extreme aches and pain all over body (this continued for 10 hours) approx. 2:30 AM: felt my throat swell/close up and could not swallow (lasted only about 20 min.) approx. 11 AM - 7 PM dizziness and fatigue whenever I stand up, pain at the injection site
61 2021-04-30 chest pain, chest discomfort mouth burning; face burning; hot and cold issues with nerves; she gets burning hot and heat waves co... Read more
mouth burning; face burning; hot and cold issues with nerves; she gets burning hot and heat waves come up; chills; metallic taste in mouth; difficulty in breathing\ntermittent difficulty in breathing; hives rash around throat and face; chest wall tingling/throat tingling/Tingling in her arms, legs, mouth, face; throat burning; throat closing; chest wall burning; chest wall closing; light-headed; anaphylactic reaction; This spontaneous case was reported by a health care professional and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy. Concomitant products included TAFLUPROST (ZIOPTAN) for Glaucoma, LIOTHYRONINE SODIUM and LEVOTHYROXINE for Thyroid disorder. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant), DYSPNOEA (difficulty in breathing\ntermittent difficulty in breathing), URTICARIA (hives rash around throat and face), PARAESTHESIA (chest wall tingling/throat tingling/Tingling in her arms, legs, mouth, face), THROAT IRRITATION (throat burning), THROAT TIGHTNESS (throat closing), CHEST PAIN (chest wall burning), CHEST DISCOMFORT (chest wall closing) and DIZZINESS (light-headed). On 05-Apr-2021, the patient experienced DYSGEUSIA (metallic taste in mouth). On an unknown date, the patient experienced ORAL DISCOMFORT (mouth burning), BURNING SENSATION (face burning), DYSAESTHESIA (hot and cold issues with nerves), FEELING HOT (she gets burning hot and heat waves come up) and CHILLS (chills). On 05-Feb-2021, ANAPHYLACTIC REACTION (anaphylactic reaction) had resolved. At the time of the report, DYSGEUSIA (metallic taste in mouth), DYSPNOEA (difficulty in breathing\ntermittent difficulty in breathing), URTICARIA (hives rash around throat and face), PARAESTHESIA (chest wall tingling/throat tingling/Tingling in her arms, legs, mouth, face), THROAT IRRITATION (throat burning), THROAT TIGHTNESS (throat closing), CHEST PAIN (chest wall burning), CHEST DISCOMFORT (chest wall closing), DIZZINESS (light-headed), ORAL DISCOMFORT (mouth burning), BURNING SENSATION (face burning), DYSAESTHESIA (hot and cold issues with nerves), FEELING HOT (she gets burning hot and heat waves come up) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, COVID-19: positive (Positive) Positive. On 31-Jan-2021, COVID-19: negative (Negative) Negative. On 02-Feb-2021, COVID-19: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. She was not admitted to the hospital. She stated she had to go back to the emergency room a few times since then for symptoms of burning and tingling in her arms, legs, mouth, face, as well as hot and cold issues with her nerves, and tightening of her throat and chest. She immediately treated with Bedadryl (unknown dosage), Pepcid40mg, Prednisone 40mg, ongoing- Prednisone 5mg daily, Pepcid 20mg daily, Claritin 10mg daily. Company comment: This case concerns a 61 Y/O F with a serious expected anaphylactic reaction, and dyspnea, urticaria, paraesthesia, throat irritation, throat tightness, chest pain, chest discomfort, dizziness, dysgeusia, oral discomfort, burning sensation, feeling hot, chills, and nervous system disorder. Event onset immediately after second dose. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-087026, US-MODERNATX, INC.-MOD-2021-087026 (E2B Linked Report).; Sender's Comments: This case concerns a 61 Y/O F with a serious expected anaphylactic reaction, and dyspnea, urticaria, paraesthesia, throat irritation, throat tightness, chest pain, chest discomfort, dizziness, dysgeusia, oral discomfort, burning sensation, feeling hot, chills, and nervous system disorder. Event onset immediately after second dose. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-087026:Case for dose 1 US-MODERNATX, INC.-MOD-2021-087026:case for dose 2
61 2021-05-01 fainting On the night of Saturday May 1 I fainted in the street (injuring my face and breaking a front tooth)... Read more
On the night of Saturday May 1 I fainted in the street (injuring my face and breaking a front tooth) and was transported to ER.
61 2021-05-02 low platelet count, platelet count decreased 2 days of flu-like sx. She then developed sudden onset of bleeding of gums bruising and vaginal blee... Read more
2 days of flu-like sx. She then developed sudden onset of bleeding of gums bruising and vaginal bleeding. High concern for thrombocytopenia. her Sx resolved at day 5 post-vaccine. Her platelets were slightly low 7 days post-vaccine. High clinical suspicion for low platelets
61 2021-05-03 blood pressure fluctuation On the 4th date after vaccine, I started having diarrhea, which lasted for 2 days. Also, very strong... Read more
On the 4th date after vaccine, I started having diarrhea, which lasted for 2 days. Also, very strong headaches 8 out 10 pain. My blood pressure started going up, and nothing was bringing it down. On the 9th day, my daughter took me to ER with blood pressure of 220/153. Was left in the hospital overnight. After that, my blood pressure was still fluctuating a lot for another week. After 2nd dose, I had blood pressure up the first day, headache and fever of 99.5. Also, pain in my leg.
61 2021-05-03 transient ischaemic attack Patient self-reported TIA approx. 40 mins after receiving 1st dose of moderna vaccine. Pt states sh... Read more
Patient self-reported TIA approx. 40 mins after receiving 1st dose of moderna vaccine. Pt states she did not go in for diagnostic imaging or medical care, but knows what a TIA "feels like," as she has had approx. 6 in her lifetime (self-reported, only 1 TIA found on her medical record).
61 2021-05-04 heart rate increased I had the second Moderna shot that afternoon, scheduled for 4:15pm but it was about 4:30pm when I go... Read more
I had the second Moderna shot that afternoon, scheduled for 4:15pm but it was about 4:30pm when I got it. I moved around as instructed by my doc, and after 15 minutes went back to my car. I noticed after another several minutes that my pulse was still elevated so opted to go back in and talk to a health care professional. Pulse was 120. Paramedic wanted me to lie down in waiting area but I didn't want to be in such a potentially germy environment, and the guy next to me who had fainted earlier was just getting up himself. She walked me back to my car, where I agreed to wait, listen to a stress relief hypnosis audio and see if my pulse rate would calm down. She came back out w/ a BP cuff and said my blood pressure was 210 over 130 (or some number over 100; I don't recall which) and she said I needed to get in an ambulance right away and go to the hospital. I said I would make my own decisions about my body and I wanted to try a couple of other things first, promised not to leave, contacted my doctor, naturopath. (Note: I did not have any other worrisome symptoms -- blurred vision, dizziness, etc. My head was a little buzzy, but whether out of fear or in reaction to the shot I didn't know. I was a little flushed). He asked me a bunch of questions, said my body hadn't had time to mount an immune response to the vaccine and that I had likely had a histamine reaction to a preservative in the vaccine (or similar), which a couple of his other patients had experienced. He asked if I'd been drinking fluids (yes, plenty), had eaten recently (no, so he suggested I have some food; I had some nuts, a little cheese and some Cheez-Its so had that), asked if I had an antihistamine around -- I did, but I don't do well with Benadryl and didn't have Claritin, but after looking through my bag found some Allervive, an herbal product he compounds. He said, "That's perfect." I took two of the three capsules and hung up. Staff were checking up on me in my car every ten minutes or so, by the way, very kind and professional as I had been quite upset at the whole "get in an ambulance" scenario. He thought some of my reaction was probably also stress-related, and I noticed before the shot that I was teary, not from anxiety but the kind you get when you feel relief after a long ordeal. I didn't feel anxiety, really, until the first blood pressure measurement. He also let me know that if the bottom number didn't drop below 100 they couldn't let me go. After eating, drinking some more water and taking the Allervive my BP was down to 138 over 75 in just a few minutes. I agreed to stick around and make sure it stuck. We re-tested again about 15 minutes later, perhaps longer, and it was the same. I had been a little flushed but that had gone away too. I left and went for a light walk and eventually drove home without incident. I had symptoms after the shot that could have been related to my body fighting off the allergic reaction or to the vaccine itself, but they were pretty mild (fatigue later that night; occasional heart rate elevation sometimes after eating or with very mild exertion -- not unusual for me if I'm "fighting off" something; sore, itchy, red blotch sized between a quarter and a half dollar at vaccination site -- it is still a little tender today and appears a bit bruised; a bit sinus headache-y for three days, especially when I bent down to tie my shoes or something like that - also not that unusual as I often seem to "cleanse" through my sinuses when I have a bug or am fighting something off). In hindsight, I think the symptoms I had after the first shot, which lasted about 9 hours, may have been fighting off the allergic reaction and not a reaction to the virus vaccine itself.
61 2021-05-05 heart rate increased 3-17-21 Shortness of breathe, intermittent fever, intermittent sore throat, fast heart rate, itching... Read more
3-17-21 Shortness of breathe, intermittent fever, intermittent sore throat, fast heart rate, itching, intermittent dizziness, weakness. Second COVID Moderna vaccine given on 4/13/2021. Worsened side effects stated above plus headache and states "both legs feel heavy".
61 2021-05-05 pulmonary embolism, chest pain, troponin increased, fibrin d dimer increased Had right chest and lower back pain and sweating during night of April 15, 2021. Also had unexplaine... Read more
Had right chest and lower back pain and sweating during night of April 15, 2021. Also had unexplained cough for one month prior to vaccine. Pain was gone by morning. Did regular exercise of walking 4 miles in morning. Same pains came back afternoon of April 16. Went to ER at 4pm on 4/16. D-Dimer and Troponin were elevated and CT scan showed pulmonary embolism in right lung. Was given Lovenox and was admitted to hospital for 2 days. Was released on Eliquis 2x per day for at least 3 months. Had two plane rides lasting for 2 hours each on 3/21 and 3/31 where I walked to bathroom once so it is unlikely these plane rides caused embolism. I am active and walk about 20 miles per week. Doctors so far have not found likely cause for this event.
61 2021-05-06 heart rate irregular, fainting, atrial fibrillation, hypertension Fainted irregular heartbeat very high blood pressure constant serious heart burn
61 2021-05-06 hypertension, palpitations Woke up freezing and felt like someone was crushing me bones. Had troubles breathing and very nauseo... Read more
Woke up freezing and felt like someone was crushing me bones. Had troubles breathing and very nauseous. This lasted 6 days. Blood pressure went sky high and had heart palpitations. Worst reaction I have ever had to anything. Almost felt need to call squad
61 2021-05-07 deep vein blood clot, pulmonary embolism 3-4 days after vaccine pt devolped DVT and PE no other known provoking factors, pt did have VTE in 2... Read more
3-4 days after vaccine pt devolped DVT and PE no other known provoking factors, pt did have VTE in 2019 and was no longer on anticoagulation
61 2021-05-07 palpitations aura seizure; aura seizure; fatigue; headache; heart palpitations; aphasia; This spontaneous case wa... Read more
aura seizure; aura seizure; fatigue; headache; heart palpitations; aphasia; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (aura seizure) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MARIJUANA for an unknown indication. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PALPITATIONS (heart palpitations), APHASIA (aphasia), FATIGUE (fatigue) and HEADACHE (headache). On 30-Apr-2021, the patient experienced SEIZURE (aura seizure) (seriousness criterion medically significant) and AURA (aura seizure). At the time of the report, SEIZURE (aura seizure), PALPITATIONS (heart palpitations), APHASIA (aphasia), AURA (aura seizure), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No medical history was provided by the reporter. Treatment included Aspirin for headache. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the previous history of previous injury, is a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the previous history of previous injury, is a confounder.
61 2021-05-09 body temperature decreased Approximately 60 hours after my second Moderna shot, I woke up at 7am with extreme dizziness and swe... Read more
Approximately 60 hours after my second Moderna shot, I woke up at 7am with extreme dizziness and sweating. I couldn't walk to the bathroom by myself. I had nausea and vomiting, severe sweating, chills and LOW body temperature (around 91 degrees) for 5 hours. Rapid breathing also....so much so that my ribs and abdomen were sore for the next several days. Around noon, I went to sleep in bed - I was exhausted - and when I woke up, I wasn't dizzy any longer. Mostly only chills after that and fatigue that lasted a couple weeks. Entire event seemed to be around 5 hours. My doctor only told me that he has "heard of many different types of reactions"....but I hadn't heard of any other people with these side effects.
61 2021-05-10 blood vessels inflammation 6 days after vaccination patient developed sudden onset pain and swelling in legs. After DVT evaluat... Read more
6 days after vaccination patient developed sudden onset pain and swelling in legs. After DVT evaluation (and ruled out) was eventually seen by PCP - suspected vasculitis. CRP was elevated.
61 2021-05-14 blood pressure increased 5/11/21 About 6 hours after injection patient's right leg was sore and swollen. She did experience a... Read more
5/11/21 About 6 hours after injection patient's right leg was sore and swollen. She did experience a sore arm as expected. Both legs were red but not itching. 5/12/21 Early the next morning she went to healthcare facility and blood pressure was elevated and they advised her to go to ER. She was not treated for anything. The swelling slowly went down throughout the day. Later that night she experienced extreme back pain. She will follow-up with PCP.
61 2021-05-14 oxygen saturation decreased Condition aggravated; Shortness of breath; Cold symptoms; neck tighing; pain in her knee; Feeling ti... Read more
Condition aggravated; Shortness of breath; Cold symptoms; neck tighing; pain in her knee; Feeling tired; Oxygen saturation decreased; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen saturation decreased), CONDITION AGGRAVATED (Condition aggravated) and DYSPNOEA (Shortness of breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product MACITENTAN for Pulmonary hypertension. The patient's past medical history included Knee arthroplasty. Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included TADALAFIL, AMLODIPINE, SELEXIPAG (UPTRAVI) and OXYGEN for an unknown indication. In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started MACITENTAN (Oral) 10 mg. In March 2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen saturation decreased) (seriousness criteria medically significant and intervention required), DYSPNOEA (Shortness of breath) (seriousness criteria medically significant and intervention required), NASOPHARYNGITIS (Cold symptoms), MUSCLE TIGHTNESS (neck tighing), ARTHRALGIA (pain in her knee) and FATIGUE (Feeling tired). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion medically significant). At the time of the report, OXYGEN SATURATION DECREASED (Oxygen saturation decreased) was resolving, CONDITION AGGRAVATED (Condition aggravated), DYSPNOEA (Shortness of breath), MUSCLE TIGHTNESS (neck tighing) and FATIGUE (Feeling tired) outcome was unknown and NASOPHARYNGITIS (Cold symptoms) and ARTHRALGIA (pain in her knee) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Oxygen saturation: 71 % (Low) 71%. On an unknown date, Oxygen saturation: 96 % (Inconclusive) improved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient stated that the night after the vaccination the oxygen saturation decreased to 71% on oxygen 10 liters per minute. Treatment for the event included a non-invasive ventilator device (trilogy machine) with improvement of oxygen saturation to 96%. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
61 2021-05-16 nosebleed Woke up at 2:30 a.m. on Friday with terrible muscle and joint pain. All day Friday had a fever betw... Read more
Woke up at 2:30 a.m. on Friday with terrible muscle and joint pain. All day Friday had a fever between 100 - 101.1 along with the pain. This lasted until around 8:00 p.m. Friday night. I had swollen glands under the left arm which is the arm used to administer the shot. Friday morning and again on Sunday morning I had a substantial bloody nose that lasted about 10 minutes each time.
61 2021-05-16 heart rate increased, heart rate irregular FATIGUE, SEVERE BODY ACHES, INCREASED PAIN IN AREAS WITH PROBLEMS, FREEZING COLD WITH 4 THICK BLANKE... Read more
FATIGUE, SEVERE BODY ACHES, INCREASED PAIN IN AREAS WITH PROBLEMS, FREEZING COLD WITH 4 THICK BLANKETS ON, WEAK, UP TO 36 HOURS IN BED CONTINUALLY. BAD DREAMS CONSTANT THEN OUT OF BALANCE NAUSEATED, OUT OF SORTS, ACHY FOR THE SECOND COMPLETE DAY, BAD DREAMS . LIGHT HEADACHE ALL DAY THIRD DAY (I DONT USUALLY GET HEADACHES . FOURTH DAY I NOTICE MY HEART BEAT SEEMS A BIT ERRATIC. I CAN FEEL IT MORE THAN NORMAL AT TIMES.TODAY SOME RACING HEART BEATS NOT TERRIBLE BUT DIFFERENT
61 2021-05-16 heart rate increased Fever, fatigue, chills, headache, rapid heartbeat, dizziness and nausea. The headache and chills wer... Read more
Fever, fatigue, chills, headache, rapid heartbeat, dizziness and nausea. The headache and chills were severe.
61 2021-05-16 hypotension, fainting Very low BP, prickly feelings in extremities, lightheadedness, fainting, chills, shaking. This happe... Read more
Very low BP, prickly feelings in extremities, lightheadedness, fainting, chills, shaking. This happened for 2 weeks. Felt good for 2 weeks then 5/14/2021 symptoms reappeared for 2 days then felt better the third day.
61 2021-05-18 atrial fibrillation Patient showed up to the hospital after her 2nd Moderna vaccine with AFib w/RVR and failed cardiover... Read more
Patient showed up to the hospital after her 2nd Moderna vaccine with AFib w/RVR and failed cardioversion. Patient was recently diagnosed with AFib a couple of days after receiving the first dose of the Moderna vaccine
61 2021-05-19 hypertension Could not breathe, chills, entire body aches, headache, congestion in head, could not lay down due t... Read more
Could not breathe, chills, entire body aches, headache, congestion in head, could not lay down due to breathing, lasted 12 hours with bad breathing, have never experienced a flu like this. Felt bad up to 3 weeks, still not breathing like before, also high blood pressure for a week until I took additional medication.
61 2021-05-21 cerebrovascular accident, loss of consciousness Fell again, breaking left leg; Breaking ankle; Breaking foot; Passed out; Stroke; Fell again; Swolle... Read more
Fell again, breaking left leg; Breaking ankle; Breaking foot; Passed out; Stroke; Fell again; Swollen arm; Did not get second Covid shot; Joint pain; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Mar-2021. The most recent information was received on 12-May-2021 and was forwarded to Moderna on 13-May-2021. This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), LOSS OF CONSCIOUSNESS (Passed out), LOWER LIMB FRACTURE (Fell again, breaking left leg), ANKLE FRACTURE (Breaking ankle) and FOOT FRACTURE (Breaking foot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced ARTHRALGIA (Joint pain). On 30-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization prolonged and medically significant), LOWER LIMB FRACTURE (Fell again, breaking left leg) (seriousness criterion hospitalization), ANKLE FRACTURE (Breaking ankle) (seriousness criterion hospitalization), FOOT FRACTURE (Breaking foot) (seriousness criterion hospitalization), FALL (Fell again), PERIPHERAL SWELLING (Swollen arm) and INCOMPLETE COURSE OF VACCINATION (Did not get second Covid shot). The patient was hospitalized for 13 days until 12-Apr-2021 due to CEREBROVASCULAR ACCIDENT, then until 12-Apr-2021 due to ANKLE FRACTURE, FOOT FRACTURE, LOSS OF CONSCIOUSNESS and LOWER LIMB FRACTURE. The patient was treated with Physical therapy for Cerebrovascular accident; Physical therapy for Lower limb fracture; Physical therapy for Ankle fracture and Physical therapy for Foot fracture. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), PERIPHERAL SWELLING (Swollen arm) and ARTHRALGIA (Joint pain) outcome was unknown, LOSS OF CONSCIOUSNESS (Passed out), FALL (Fell again) and INCOMPLETE COURSE OF VACCINATION (Did not get second Covid shot) had resolved and LOWER LIMB FRACTURE (Fell again, breaking left leg), ANKLE FRACTURE (Breaking ankle) and FOOT FRACTURE (Breaking foot) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant product use was reported. Treatment medication included Benadryl. Very limited information regarding these events has been provided at this time. This case also refers to an incomplete schedule of vaccination. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Case upgraded to serious (Hospitalization), Added Additional events experienced, Events description, and updated Treatment information.
61 2021-05-21 palpitations heart palpitations; itching all over the body; cannot walk very long, and legs are shaky.; short of ... Read more
heart palpitations; itching all over the body; cannot walk very long, and legs are shaky.; short of breath; Athma exacerbations; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (short of breath), PALPITATIONS (heart palpitations) and PRURITUS (itching all over the body) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Gastric bypass. Concurrent medical conditions included Asthma. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPNOEA (short of breath) (seriousness criterion medically significant) and ASTHMA (Athma exacerbations). On an unknown date, the patient experienced PALPITATIONS (heart palpitations) (seriousness criterion medically significant), PRURITUS (itching all over the body) (seriousness criterion medically significant) and GAIT DISTURBANCE (cannot walk very long, and legs are shaky.). At the time of the report, DYSPNOEA (short of breath) and ASTHMA (Athma exacerbations) had not resolved and PALPITATIONS (heart palpitations), PRURITUS (itching all over the body) and GAIT DISTURBANCE (cannot walk very long, and legs are shaky.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. The patients treatment medication information included oxygen treatment, Benadryl, and prednisone. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Additional Information Was received. Updated the reporters information and added events(Palpitations , Pruritus, Gait Disturbance); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
61 2021-05-25 blood pressure increased, dilation of blood vessels Two days after second shot my toes and feet started turning red. My veins on the top of my foot and ... Read more
Two days after second shot my toes and feet started turning red. My veins on the top of my foot and back of ankle become enlarged. My blood pressure readings are much higher than they ever have been. I went to ER on 5/24 because my blood pressure was 190/115. I have never had blood pressure that high. Ever. The ER Dr. Told me to take an extra 10 mgs of lisinopril In the evening. It hasn't helped. Im scared because I don't have health insurance right now. I have applied for insurance but haven't heard anything yet. This is the first time I haven't had health Insurance in my adult life. Is this all a side affect, and it will go away soon.? I told the Dr in the ER what was going on with my feet and veins, but he didn't say anything.
61 2021-05-27 palpitations After 3 minutes,,I felt palpitations-weak-shaking. I went to the ER right away. for the first dose.... Read more
After 3 minutes,,I felt palpitations-weak-shaking. I went to the ER right away. for the first dose..I felt the same and I went to urgent care right away.
61 2021-05-31 deep vein blood clot Pt reports she had constant left arm pain, located in the deltoid region from the date of the 1st in... Read more
Pt reports she had constant left arm pain, located in the deltoid region from the date of the 1st injection. 2nd injection was given 3/11/21 and the pt has had pain radiating upward to posterior right shoulder, axillary area, and distal upper arm. The pt did supportive care, took otc analgesics and pain continued to worsen. Pt was evaluated in the ER 6/1/2021 and diagnosed with a DVT to left upper arm brachial vein.
61 2021-06-02 palpitations 5am 5/01 - severe dizziness, loss of vision, shakiness heart palpitations 5am 5/02... Read more
5am 5/01 - severe dizziness, loss of vision, shakiness heart palpitations 5am 5/02 - severe dizziness 7:30 05/02 - Post coffee, severe heart palpitations vertigo
61 2021-06-02 inflammation of the pericardium Joint pain and rash starting within week after vaccine administered. Pericarditis diagnosis on 5/7/2... Read more
Joint pain and rash starting within week after vaccine administered. Pericarditis diagnosis on 5/7/2021. Was hospitilized. Rheumatoid Arthritis probable with elevated RA factor, positive ANA, and High ANA titer. Awaiting other autoimmune test results to verify diagnosis.
61 2021-06-03 heart attack Patient presented to the ED and was subsequently admitted for NSTEMI within 6 weeks of receiving COV... Read more
Patient presented to the ED and was subsequently admitted for NSTEMI within 6 weeks of receiving COVID vaccination.
61 2021-06-03 heart rate increased, hypertension Dizziness, rapid heart rate, high blood pressure; throat ?burning?; intense coughing, lessened abili... Read more
Dizziness, rapid heart rate, high blood pressure; throat ?burning?; intense coughing, lessened ability to breathe.
61 2021-06-06 cerebrovascular accident Acute CVA (cerebrovascular accident) Cerebral infarction, unspecified
61 2021-06-07 cerebrovascular accident, stroke on 5/19/21 pt experienced "tingling and a rushing feeling" throughout her body. she then could not m... Read more
on 5/19/21 pt experienced "tingling and a rushing feeling" throughout her body. she then could not move the left side of her body. Per ER records, pt suffered an infarct in the brain that day: .ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY THROMBOSIS OF RIGHT INTERNAL CAROTID ARTERY
61 2021-06-08 heart attack Patient received the second Moderna vaccine shot on 041021.Wednesday morning at 6:15am , May 19 she ... Read more
Patient received the second Moderna vaccine shot on 041021.Wednesday morning at 6:15am , May 19 she felt bad that morning, She received a 4mm stent for the 100% blockage in the left anterior descending artery. She had a massive heart attck. She remained in the hospital for 3 days. She has 0 Risk factors for heart disease. Hospital. 3 day Stay May 19 before noon, released May 22 2021
61 2021-06-08 blood clot, chest pain, pulmonary embolism Pulmonary embolism in Right lung. Subsequent finding was multiple blood clots throughout both lungs... Read more
Pulmonary embolism in Right lung. Subsequent finding was multiple blood clots throughout both lungs. Gave blood 3 weeks after second Moderna injection, blood clotting would not allow a full donation (right arm). Upon checking in to the ER for chest pain on April 17, blood clotting would not allow IV hook up in right arm.
61 2021-06-09 inflammation of the pericardium Restrictive pericarditis
61 2021-06-10 loss of consciousness Haematochezia; Loss of consciousness; Diarrhoea; Nausea; This case was received via FDA VAERS on 01-... Read more
Haematochezia; Loss of consciousness; Diarrhoea; Nausea; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of HAEMATOCHEZIA (Haematochezia) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Allergy to antihistamines.) and Diabetes. On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced HAEMATOCHEZIA (Haematochezia) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea) and NAUSEA (Nausea). At the time of the report, HAEMATOCHEZIA (Haematochezia), LOSS OF CONSCIOUSNESS (Loss of consciousness), DIARRHOEA (Diarrhoea) and NAUSEA (Nausea) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. The patient reported blood in her stool. Concomitant products were not provided. Treatment medication were not reported. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per IME list; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Authority reporting. Events seriousness per IME list
61 2021-06-10 fluid around the heart Patient received 1st dose 2/10/21, 2nd dose on 3/10/2021 She presented to the ED on 4/27 with dyspne... Read more
Patient received 1st dose 2/10/21, 2nd dose on 3/10/2021 She presented to the ED on 4/27 with dyspnea and found to have large pericardial effusion with early tamponade. Was transferred to hospital and on 4/28 had therapeutic pericardiocentesis. Started on colchicine for presumed viral/immune pericarditis. Seen in cardiologist office on 6/9/2021. Doing wqell with resolution of effusion.
61 2021-06-11 heart attack, arrhythmia, chest pain Patient declined second vaccination due to adverse; nausea; stabbing pain in heart and her internal ... Read more
Patient declined second vaccination due to adverse; nausea; stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack; stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack; chest pain; blisters on head becoming infected; skin on entire body became red; skin on entire body became red, itchy; entire body having a burning sensation; scalp became purple and developed multiple blisters; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack) and MYOCARDIAL INFARCTION (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included MRSA wound infection. Concurrent medical conditions included Anginal pain, Heart failure, Post-traumatic stress disorder, COPD, Neuropathy, Mucous discharge, Yeast infection (under breasts and abdomen fold), Acid reflux (esophageal), Cholesterol total abnormal NOS, Sleep problem, Depression and Cardiac assistance device user (implantable defibrillator). Concomitant products included RABEPRAZOLE SODIUM (ACIPHEX) for Acid reflux (esophageal), NITROGLYCERIN for Anginal pain, METOPROLOL and ISOSORBIDE DINITRATE (ISOSORBIDE [ISOSORBIDE DINITRATE]) for Anginal pain and Heart failure, IPRATROPIUM and MONTELUKAST for COPD, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, FLUOXETINE and BUPROPION for Depression, ACETYLSALICYLIC ACID (ASPIRIN 81) for Heart disorder, POTASSIUM and BUMETANIDE;POTASSIUM for Heart failure, GUAIFENESIN for Mucous discharge, GABAPENTIN for Neuropathy, CABERGOLINE for Pituitary disorder NOS, TERAZOSIN HYDROCHLORIDE (PROZOSIN) for Post-traumatic stress disorder, DULOXETINE HYDROCHLORIDE (DOXETIN) for Sleep disorder, NYSTATIN for Yeast infection. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced ERYTHEMA (skin on entire body became red), PRURITUS (skin on entire body became red, itchy), SKIN BURNING SENSATION (entire body having a burning sensation) and BLISTER (scalp became purple and developed multiple blisters). On 05-Apr-2021, the patient experienced BLISTER INFECTED (blisters on head becoming infected). On 18-May-2021, the patient experienced CHEST PAIN (chest pain). On 30-May-2021, the patient experienced ARRHYTHMIA (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack) (seriousness criterion medically significant), MYOCARDIAL INFARCTION (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack) (seriousness criterion medically significant) and NAUSEA (nausea). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Patient declined second vaccination due to adverse). The patient was treated with NITROGLYCERIN (intravenous) on 30-May-2021 for Arrhythmia and Heart attack, at a dose of 1 dosage form and CEFRADINE (LINDEX [CEFRADINE]) (topical) for Scalp blister, at a dose of 1 dosage form. At the time of the report, ARRHYTHMIA (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack), MYOCARDIAL INFARCTION (stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was have an arrhythmia and/or heart attack), ERYTHEMA (skin on entire body became red), PRURITUS (skin on entire body became red, itchy), SKIN BURNING SENSATION (entire body having a burning sensation), BLISTER (scalp became purple and developed multiple blisters), BLISTER INFECTED (blisters on head becoming infected) and NAUSEA (nausea) outcome was unknown, CHEST PAIN (chest pain) had not resolved and INTENTIONAL DOSE OMISSION (Patient declined second vaccination due to adverse) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Troponin: normal (normal) normal. On 30-May-2021, Troponin: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported that on 18-MAY-2021 she experienced chest pain and went to the emergency room via ambulance. Patient did not receive any medication in emergency room and was discharged 17 hours later because her Troponin levels were normal. On 30-MAY-2021 patient had stabbing pain in heart and her internal defibrillator sent the manufacturer a message that she was having an arrhythmia and/or heart attack. The patient was air lifted to the hospital. The patient stated that she was put on a Nitroglycerin IV drip and antiemetics in the emergency room. The patient's troponin levels came back normal and was discharged after 12 hours in the emergency room. At the time of report, on 02-JUN-2021, patient stated that she still had chest pain, and the pain remained 3 out of 10. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. further information has been requested. For the event "Intentionally missed dose" causality assessment is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. further information has been requested. For the event "Intentionally missed dose" causality assessment is not aplicable.
61 2021-06-13 cardiac arrest, cerebrovascular accident, heart attack, heart attack stroke and MI came in with symptoms of stroke but symptoms for 24 hours so did not receive tPa. MRI ... Read more
stroke and MI came in with symptoms of stroke but symptoms for 24 hours so did not receive tPa. MRI showed brainstem infarct. Statin was increased and started on plavix 75 mg daily for 3 weeks due to small stroke with low NIH. Patient came back in 3 days later due to STEMI and went into cardiac arrest. patient died after 1 hour of resuscitation
61 2021-06-13 chest discomfort Patient reported chest tightness after the vaccine into the night which resolved itself the next mor... Read more
Patient reported chest tightness after the vaccine into the night which resolved itself the next morning. Patient reported hives the next morning lasting 5 days. Redness at the site of injection presented itself after 7 days of the vaccine and was still there on 06/13/21
61 2021-06-13 inflammation of the heart muscle, heart rate increased nausea, vomiting, weak, rapid heart beat, insomnia. Went to hospital (Medical Center) where they pe... Read more
nausea, vomiting, weak, rapid heart beat, insomnia. Went to hospital (Medical Center) where they performed test on my heart, echocardiogram, ekgs.
61 2021-06-14 chest discomfort After I had the 2nd dosage of the Moderna shot and it felt like I was going to have a heart attack (... Read more
After I had the 2nd dosage of the Moderna shot and it felt like I was going to have a heart attack (like someone threw a blanket over me because I became clammy, sweaty, and weak. I went to see my Doctor and she did an EKG in the office and decided that I need to go to see a Cardiology as a precaution. The Cardiologist will be performing an Echo Cardiogram an a stress test on my heart.
61 2021-06-15 low blood platelet count, platelet count decreased ITP, Low Platelets
61 2021-06-16 lightheadedness Patient received her second dose of her Covid shot (Moderna). After vaccination, patient stated that... Read more
Patient received her second dose of her Covid shot (Moderna). After vaccination, patient stated that she felt very anxious, light-headed and had a headache. Tried to get up and stated that she almost fell and began crying. Counseled the patient on potential effects of the vaccine and offered to call emergency services, which she declined. She stated that she would have someone else pick her up since she felt like she couldn't drive and felt dizzy. Patient tolerated 1st vaccine and no allergic reaction present. Patient left under her own power from the pharmacy for her ride. Sent message to prescriber as well regarding patient and incident.
61 2021-06-17 chest pain, palpitations, palpitations Chest pains, pounding skipping heart beats started 2 weeks after shot and lasted three weeks before ... Read more
Chest pains, pounding skipping heart beats started 2 weeks after shot and lasted three weeks before resolving.
61 2021-06-17 palpitations, chest pain, palpitations Chest pains with pounding heartbeats and skips in beats. Started 2 weeks after shot. Continued for... Read more
Chest pains with pounding heartbeats and skips in beats. Started 2 weeks after shot. Continued for two weeks. Eventually resolved.
61 2021-06-17 pulmonary embolism pt developed pulmonary embolism and passed away 6/14/2021
61 2021-06-18 heart attack Indigestion; Hiatal hernia; Weakness; Inflammation; Heart attack; Reflux gastritis; Headache; Fever;... Read more
Indigestion; Hiatal hernia; Weakness; Inflammation; Heart attack; Reflux gastritis; Headache; Fever; Sleep disturbance; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SPIRONOLACTONE, LISINOPRIL, TICAGRELOR (BRILINTA), ATORVASTATIN and METOPROLOL SUCCINATE for an unknown indication. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache) and PYREXIA (Fever). On 09-May-2021, the patient experienced REFLUX GASTRITIS (Reflux gastritis). On 19-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced DYSPEPSIA (Indigestion), HIATUS HERNIA (Hiatal hernia), ASTHENIA (Weakness) and INFLAMMATION (Inflammation). The patient was treated with MAGNESIUM OXIDE HEAVY, SODIUM BICARBONATE (ANTACID C) at a dose of 1 dosage form; NITROGLYCERIN at a dose of 1 dosage form and Surgery (Stent insertion) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Heart attack), SLEEP DISORDER (Sleep disturbance), DYSPEPSIA (Indigestion), HIATUS HERNIA (Hiatal hernia), ASTHENIA (Weakness), INFLAMMATION (Inflammation), REFLUX GASTRITIS (Reflux gastritis), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electrocardiogram: abnormal (abnormal) abnormal. In 2021, Endoscopy: abnormal (abnormal) abnormal. Treatment information included proton pump inhibitor. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-108529, BE-MODERNATX, INC.-MOD-2021-108559 (E2B Linked Report). This case was linked to MOD-2021-213971 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-108529:(crosslink) BE-MODERNATX, INC.-MOD-2021-108559:(crosslink)
61 2021-06-21 chest discomfort Patient said that she was having tightness of chest/slight itching,back tightness , she stated that... Read more
Patient said that she was having tightness of chest/slight itching,back tightness , she stated that she had some allergies that periodically caused this type of reaction. I gave her 25mg of generic benadryl. she waited a few minutes and said she felt better but knew that she would have a headache later today., I called her at home at about 5pm and she stated that she was ok, but she did get the headache she expected.
61 2021-06-23 blood pressure increased Blood pressure elevated to 245/125, at ER. Stayed elevated for several hours. I was not previously ... Read more
Blood pressure elevated to 245/125, at ER. Stayed elevated for several hours. I was not previously on any blood pressure meds, but am now.
61 2021-06-23 chest pain, chest discomfort Second does received 5-13-21 10:15 a.m. symptoms after first shot: shortness of breath, chest pain,... Read more
Second does received 5-13-21 10:15 a.m. symptoms after first shot: shortness of breath, chest pain, chest tightness, extreme fatigue, lack of appetite. After 2nd vaccine the symptoms got 200% worse about 3 days after the 2nd vaccine. Lingering symptoms still continue today.
61 2021-06-27 chest discomfort Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Sy... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
61 2021-06-27 chest pain, palpitations I started getting dizzy and then heart palpitations, shortness of breath, chest pains, sharp shootin... Read more
I started getting dizzy and then heart palpitations, shortness of breath, chest pains, sharp shooting pains on left side of neck by my ear. All but chest pains continue. Legs are swollen. Will be seeing clinic on July 7th at 2pm.
61 2021-06-27 inflammation of the pericardium pericarditis
61 2021-06-29 blood pressure increased blood pressure reading have been like a roller coaster, up and down; right arm hurt; Diverticulitis;... Read more
blood pressure reading have been like a roller coaster, up and down; right arm hurt; Diverticulitis; costochondritis; massive pain in the rib cage area; pressure in the lower abdomen; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 8370299) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pneumonia (missed diagnosis of COVID, treated for pneumonia as there were no COVID tests available.) in February 2020. Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), VITAMIN D NOS, PROBIOTICS NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant), COSTOCHONDRITIS (costochondritis), MUSCULOSKELETAL CHEST PAIN (massive pain in the rib cage area), ABDOMINAL DISCOMFORT (pressure in the lower abdomen ) and VACCINATION SITE PAIN (right arm hurt). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (blood pressure reading have been like a roller coaster, up and down). At the time of the report, DIVERTICULITIS (Diverticulitis), COSTOCHONDRITIS (costochondritis), MUSCULOSKELETAL CHEST PAIN (massive pain in the rib cage area), ABDOMINAL DISCOMFORT (pressure in the lower abdomen ), BLOOD PRESSURE INCREASED (blood pressure reading have been like a roller coaster, up and down) and VACCINATION SITE PAIN (right arm hurt) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 155/84 (High) elevated blood pressure readings. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Blood tests and CAT scan were done in the ER. Results were not provided. Patient was treated with a 10 day course of two antibiotics. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
61 2021-06-30 chest discomfort Chest tightness upon activity that has continued for past 2.5 months. Diagnosed as asthma due to a d... Read more
Chest tightness upon activity that has continued for past 2.5 months. Diagnosed as asthma due to a dust mite allergy. Treated with inhalers -- Alvesco and Albuterol and is now mostly manageable. Recent dust mite mitigation efforts -- covers for mattress and pillows, frequently washing of bedding and frequent vacuuming.
61 2021-06-30 palpitations, heart attack Myocardial infarction probable silent after acute and sustained symptoms of upper arm and leg disco... Read more
Myocardial infarction probable silent after acute and sustained symptoms of upper arm and leg discomfort. Elevated diastolic bp and heart pounding. No prior history suggestive of CAD.
61 2021-07-02 hypertension Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild
61 2021-07-04 deep vein blood clot RIGHT lower extremity DVT
61 2021-07-04 heart attack Heart Attack with 100% blockage of RCA.
61 2021-07-06 chest discomfort, heart rate increased Fast heartbeat (felt like I was having a heart attack), left chest discomfort, bad headache, dizzy, ... Read more
Fast heartbeat (felt like I was having a heart attack), left chest discomfort, bad headache, dizzy, GI issues, body aches, chills, fatigue
61 2021-07-06 nosebleed shortness of breath, very dehydrated, dry skin, bloody nose due to being so dry, sore arm
61 2021-07-06 ischaemic stroke Ischemic stroke
61 2021-07-06 pulmonary embolism Day after vaccine had extreme version of usual vaccine reactions, took Tylenol, still lingering effe... Read more
Day after vaccine had extreme version of usual vaccine reactions, took Tylenol, still lingering effects the next day, extremely winded while trying to walk, several weeks later symptoms worsened. Extreme fatigue. 2 weeks after shot, was at elevation and extremely winded (usually not someone with respiratory issues). Missed work, drove to ER, lungs clotted. Doctor did not find any clot in legs, assumed it was Covid but did not have any other symptoms of Covid and negative covid test. 6 month recovery expected. Taking Xarelto coagulant, initially was on Eliquis, but responded poorly now on Xarelto.
61 2021-07-07 blood pressure decreased, fainting On May 24, 2021, I woke up and within a few minutes experience 3 syncope episodes. Went to the ED an... Read more
On May 24, 2021, I woke up and within a few minutes experience 3 syncope episodes. Went to the ED and spent the night in the hospital in observation. All tests normal. Explanation was I was likely fighting a virus that dropped my BP. Don't know if it was Covid or vaccine-related or if it was my vaccine was working but it was an unexpected adverse event. No history of syncope or any underlying conditions or co-morbidities.
61 2021-07-07 palpitations Initially on evening of receiving the 2nd vaccine, I had extreme chills, fatigue, muscle aches, join... Read more
Initially on evening of receiving the 2nd vaccine, I had extreme chills, fatigue, muscle aches, joint pain, pain at vaccine site on left arm, head ache and sensitivity to light. These symptoms lasted for several days. However the fatigue has continued ever since. I only have energy for a couple of hours in the morning, then I am ready for a nap or only a low key day. After two weeks I felt heart palpitations and went to the emergency room to be check out. Since then I followed up with a doctor who referred me to a cardiologist. I will be having a stress test on future date. On 6/26/2021 I woke up feeling all the same symptoms as the day of the shot. I was so tired I could barely keep my eyes open and slept most of the day. I was better the next day, but continue to feel fatigued. I had to quit my full time job due to the lack of stamina. two weeks after the 2nd vaccine.
61 2021-07-15 cerebrovascular accident Fully vaccinated patient test positive for COVID upon admission to the hospital. Admitted 06/20/21 ... Read more
Fully vaccinated patient test positive for COVID upon admission to the hospital. Admitted 06/20/21 for stroke. No s/s of COVID throughout stay. No fever, cough, O2 needs. Discharged without any COVID concerns.
61 2021-07-16 chest pain Patient developed chest pains and shortness of breath that has persisted for a couple of months and ... Read more
Patient developed chest pains and shortness of breath that has persisted for a couple of months and is gradually resolving. She had presented to the ER after a couple of weeks and had negative cardiac troponins and normal EKG but had notable low platelet counts. Subsequent follow-up primary care with persistent symptoms her D-dimer was negative in platelets had returned normal but patient continued to have symptoms. Symptoms have gradually improved.
61 2021-07-18 transient ischaemic attack My lips were numb 45 minutes after my vaccine and 7 or 8 days later I had a mini stroke but unsure i... Read more
My lips were numb 45 minutes after my vaccine and 7 or 8 days later I had a mini stroke but unsure if related to the vaccine.
61 2021-07-20 palpitations high fever, (103-104) nausea, vomiting, body aches, It felt like i had COVID all over again. It last... Read more
high fever, (103-104) nausea, vomiting, body aches, It felt like i had COVID all over again. It lasted 3 days at this rate then by day 5 I was able to return to work. I have not taken the 2nd shot at this time because I am afraid to do so. I have also had heart palpitations since taking this first shot.
62 2021-01-01 blood pressure increased Elevated bp hours after vaccine along with sore arm. Next morning, muscle/joint aches, inability to ... Read more
Elevated bp hours after vaccine along with sore arm. Next morning, muscle/joint aches, inability to ambulated, severe headache, brain fog, chills, shaking/trembling,pain all over. Evening of 1-2-2021, itching all over and hives on trunk.
62 2021-01-02 chest discomfort Started in arms - heaviness in muscle's - went to legs - (not joints). heaviness in center of chest ... Read more
Started in arms - heaviness in muscle's - went to legs - (not joints). heaviness in center of chest & tightness in neck.
62 2021-01-03 heart rate increased Felt a flush of heat, and then HR elevated for a few minutes, making it hard to catch my breath for ... Read more
Felt a flush of heat, and then HR elevated for a few minutes, making it hard to catch my breath for a brief amount of time.
62 2021-01-04 heart flutter Sore arm beginning in the evening which got progressively worse for a couple of days then subsided c... Read more
Sore arm beginning in the evening which got progressively worse for a couple of days then subsided completely. Some heart fluttering and some slight shortness of breath beginning a couple of days after. More a nuisance. No other symptoms I'm aware of although every little thing I feel now I think may or may not be a symptom like slight head throb but not consistent pain. Not sure because of vaccine.
62 2021-01-05 heart rate increased, blood pressure decreased Within 30 seconds to 1 minute, I had a strange taste in my mouth. It was neither pleasant nor unplea... Read more
Within 30 seconds to 1 minute, I had a strange taste in my mouth. It was neither pleasant nor unpleasant, just different. Following this I began to feel bad. It felt as if my blood pressure dropped. I became dizzy and had to hold my head up with my hands. Thank God, I was in my car when I got this injection, or I would have fainted. I felt my temp increase, and my breathing and heart rate became rapid. I used meditation to get my breathing under control, and within a few minutes, I broke out in a cold sweat all over. Then these symptoms subsided and I felt much better. This entire reaction was under 5 minutes. 15 minutes after the injection, a nurse returned to my car and I told her that the vaccine triggered a hot flash or something. My arm became very sore, and that night I felt a goose-egg lump, very warm at the injection site. Also, the left side of my throat felt tight, and it hurt. This morning my arm is still very sore, but no lump, and my throat feels better.
62 2021-01-05 palpitations, chest pain, fast heart rate within 5 minutes after injection had palpitations, flushing , tachycardia of 124 and BP of 154/106. ... Read more
within 5 minutes after injection had palpitations, flushing , tachycardia of 124 and BP of 154/106. Skin rash of erythema and mottling, no urticaria, feeling of impending doom, burning in chest. given Benadryl and symptoms resolved after 30-40 minutes
62 2021-01-06 chest discomfort, heart rate irregular Slightly dizzy right after the injection. Chills occured. Wthin 4 hours, pressure in chest which wen... Read more
Slightly dizzy right after the injection. Chills occured. Wthin 4 hours, pressure in chest which went into an irregular heart beat. I went to sleep woke up no irregular beats but severe chills, loss of appetite for 8 days. Lost 5 lbs. Followed up with medical Dr. She told me to contact you and not to take the second shot.
62 2021-01-06 hypertension Dizziness, Myalgia, Arthralgia & HYPERtension Narrative:
62 2021-01-06 palpitations Chills, no fever. %hours after heart palpitations followed by nausea and vomiting. Temp up to 102.4.... Read more
Chills, no fever. %hours after heart palpitations followed by nausea and vomiting. Temp up to 102.4. Lasted 48 hours.
62 2021-01-07 hypertension Confusion, Fever, SkinRash, Rash, Diarrhea, NauseaVomiting, HYPERtension, SWOLLEN TONGUE W/RASH; HIG... Read more
Confusion, Fever, SkinRash, Rash, Diarrhea, NauseaVomiting, HYPERtension, SWOLLEN TONGUE W/RASH; HIGH SED RATE
62 2021-01-07 hypertension Blurred vision, numbness in the mouth and high blood pressure. Benadryl 25 mg PO was administered a... Read more
Blurred vision, numbness in the mouth and high blood pressure. Benadryl 25 mg PO was administered approximately 1 hour post vaccination. Employee was instructed to see primary attending physician.
62 2021-01-08 chest discomfort 8 hours after vaccine I experienced stomach pain and nausea. I then became very ill and extremely w... Read more
8 hours after vaccine I experienced stomach pain and nausea. I then became very ill and extremely weak. I was laying on floor. Very difficult to talk and very dizzy. Unable to walk. Called 911 and went to ER. Had chest pressure and cardia work up was done. Dx wi ST elevation.
62 2021-01-08 heart rate increased, hypertension Headaches, hot flushes, and vital changes She experienced headaches and hot flushes right after vac... Read more
Headaches, hot flushes, and vital changes She experienced headaches and hot flushes right after vaccination Her BP went up to 164/72 (baseline BP 120/80), and HR up to 103 She stated she felt anxious while answering questions. HR down to 80 , but BP stayed high (160/70) in about 15 minutes Provider at the observation room checked her, instructed to continue to check vitals for the next couple of days, and let her leave. She was sent home.
62 2021-01-10 low blood oxigenation WITHIN 18 HRS FROM INJECTION / SYMPTOMS STARTED SATURDAY 01/09/2021 @ ~ 1400HRS DIARRHEA CHILLS LOW ... Read more
WITHIN 18 HRS FROM INJECTION / SYMPTOMS STARTED SATURDAY 01/09/2021 @ ~ 1400HRS DIARRHEA CHILLS LOW GRADE FEVER 99.8 JOINT PAIN JAW PAIN BODY ACHES HEADACHE NEAUSEAUS LIGHT HEADED FATIGUE HYPOXIC ON EXERTION SYPMPTOM SUBSIDED ON SUNDAY 01/10/2021 @ ~ 1500HRS
62 2021-01-10 palpitations, heart rate abnormal Received Moderna covied vaccine @ 8:05 am then 20 minutes after the injection i developed Palpitatio... Read more
Received Moderna covied vaccine @ 8:05 am then 20 minutes after the injection i developed Palpitations HR=130,redness on neck, chest & forehead area, Petechiae rashes on both arms.BP 200/109.was sent to ER for further evaluation.EKG was done,NS 500c given IV ,blood drawn & sent to laboratory for CBC & BMP. released from ER @ 12.30 when my BP & HR was normal.redness on my neck & chest was less but Petechiae rashes subsided in the evening of same day.Early morning Friday Jan.8,2021 temp was 100.2.felt bodyaches & headache. when i checked my temp i noticed a lymph node in my left armpit.
62 2021-01-12 blood pressure increased 24 hours after the vaccine I had a 102 fever overnight. The next day, my feet were hurting, like bu... Read more
24 hours after the vaccine I had a 102 fever overnight. The next day, my feet were hurting, like burning. They continued like this but with fluctuating severity. My calves and shin muscles began to be sore. I sought out acupuncture and myofascia release work to help. It did help temporarily. I started to have left ankle pain, not like a sprain, like tendonitis or inflammation. It continued to hurt to walk and the muscles more painful. I started having darker urine about 4 days after the vaccine. I drank cranberry juice and took a kidney/bladder supplement, increased fluids, but it continued dark. I went to the Urgent Care on January 7th c/o muscle pain and dark urine. My blood pressure was elevated, 179/100..unusual for me, and my urine was neg so it was sent for culture and blood was drawn for CBC and metabollic panel and Creatine Kinase
62 2021-01-13 chest discomfort Chest tightness, dizziness, "jittery"
62 2021-01-15 fainting Sore Arm at site of injection onset couple of hours after shot Fever of 100.2 onset approximately 1... Read more
Sore Arm at site of injection onset couple of hours after shot Fever of 100.2 onset approximately 14 hours after the shot Chills and slight headache onset 14 hours after shot Fainting onset about 14 hours after the shot Aches and Pains onset about 14 hours post injection Fatigue
62 2021-01-16 hypertension Shortness of breath, unusual high blood pressure, dizziness, headaches, chills
62 2021-01-18 blood pressure increased, heart rate increased About 3 hours after receiving the vaccine my blood pressure went up 188/98 and my heart rate went... Read more
About 3 hours after receiving the vaccine my blood pressure went up 188/98 and my heart rate went up. 122 I could feel my heart beating fast. I laid down thinking it would go away. I called my Dr at 7:00pm and he told me to take a Clonidine .1 mg and rest. In an hour my BP and heart rate were down to normal. BP 133/78 heart rate 100. I am not sure if this was from the Vaccine or the anxiety of getting it and not knowing if I was going to be allergic to it. I have had no issues since. Should I get the 2nd dose?
62 2021-01-18 blood pressure increased, palpitations The first day I had some heart palpitations in the afternoon about 3:00 -3:30 P.M. I also was tired... Read more
The first day I had some heart palpitations in the afternoon about 3:00 -3:30 P.M. I also was tired. Five days later I was sick and vomiting and my blood pressure was elevated, but I was uncertain if that was caused by the vaccine.
62 2021-01-18 low blood oxigenation Patient developed a fever starting 01/07/2021 and progressed to eventual decrease in condition overa... Read more
Patient developed a fever starting 01/07/2021 and progressed to eventual decrease in condition overall. By 01/09/2021 she was bed bound, NPO, consistent fever, gurgling, hypoxic requiring 2-4 L of oxygen via nasal canula, and significant secretions requiring glycopyrrolate and suction. This progressed for the next days with decreasing condition and increase of above symptoms. Patient eventually could not swallow and developed rhonchi in lungs.
62 2021-01-20 low blood oxigenation numbing of tongue, numbing of face, swelling of throat, body weakness, lack of oxygen short period o... Read more
numbing of tongue, numbing of face, swelling of throat, body weakness, lack of oxygen short period of insomnia lasting two night. body ache, smelling of injection site along with redness.
62 2021-01-21 palpitations AT 1040 EMPLOYEE C/O PALPITATION, NOT IN DISTRESS
62 2021-01-21 palpitations Slightly scratchy throat and heart started racing for a few seconds. Recorded heart rate was noted ... Read more
Slightly scratchy throat and heart started racing for a few seconds. Recorded heart rate was noted at 83 bpm.
62 2021-01-24 chest discomfort Pt reported ~ 30 minutes after vaccine that she had a funny feeling in her throat, felt like throat ... Read more
Pt reported ~ 30 minutes after vaccine that she had a funny feeling in her throat, felt like throat was swelling and tightness in her chest. She was given 0.3mg epi via epi pen, 50mg benadryl IM, 8mg dexamethasone IM, albuterol neb and O2 via nasal cannula. Pt reported improving sx. and was transported to local ER via EMS. She was monitored and released later that evening
62 2021-01-24 palpitations, heart rate increased Fatigue,headache,muscle pain,joint pain,chills,a fast heartbeat, palpitations, dizziness and weaknes... Read more
Fatigue,headache,muscle pain,joint pain,chills,a fast heartbeat, palpitations, dizziness and weakness
62 2021-01-24 palpitations Received vaccine at 9:45 AM and advised due to anaphylactic reaction in the past due to bee stings, ... Read more
Received vaccine at 9:45 AM and advised due to anaphylactic reaction in the past due to bee stings, advised to stay 30 minutes. At 10:03 AM husband stated wife was not feeling well. 10"05 called EMS. Blood pressure 197/88, chills, heart racing, and SOB. 10:10 ambulance here. Checked out patient and at 10:22 EMS dismissed patient. Vitals 140/98, HR 88, and Pulse Ox 97%.
62 2021-01-25 heart rate abnormal, palpitations Thursday 1/21/21 shot; Friday 01/22/2021, 2:30am woke with extreme body ache, sweats, chills, felt l... Read more
Thursday 1/21/21 shot; Friday 01/22/2021, 2:30am woke with extreme body ache, sweats, chills, felt like legs were being ripped from body, headache, could not move, teeth chattering, heart beat so extreme I thought my heart was going to pop out of my chest, this last adverse effect only lasts for about seconds. I asked Siri & Alexa if it was ok to take pain reliever after 2nd COVID19 vaccine and they were useless. i had temp of 102 degree. I finally called someone who had reaction and they said Tylenol or Advil. I took Advil at 6am Friday 1/22. All adverse effects continued throughout day except extreme heart palp. I took Advil at 11am & 3pm, I took Tylenol at 7pm and aspirin at 11:30pm & On Saturday at 3:30 am,. Advil and Tylenol helped slightly, aspirin worked best or I was just exhausted. I woke up on Saturday at 8:30am and all was ok, except just tired a and my lower back is in pain still with numbness down leg. Probably from laying around.
62 2021-01-26 chest discomfort Dry throat, chest pressure mild, light headed.
62 2021-01-26 palpitations, heart rate increased body aches; temperature on 08JAN2021 was 100.2; headache; palpitations; blood pressure was 200/109; ... Read more
body aches; temperature on 08JAN2021 was 100.2; headache; palpitations; blood pressure was 200/109; heart rate which was 130; chest and neck was red; rashes on both arm; left arm in the evening was soo stiff up to her elbow; developed a lymph node in her left armpit; A spontaneous report was received from a 62-years-old, female nurse, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced palpitations, blood pressure was 200/109, heart rate which was 130, chest and neck was red, rashes on both arms, left arm in the evening was so stiff up to her elbow, body aches, developed a lymph node in her left armpit, temperature on 08JAN2021 was 100.2, and headache. The patient's medical history included being diabetic. Products known to have been used by the patient, within two weeks prior to the event, included sitagliptin metformin, clonidine, losartan, repaglinide, rosuvastatin, and glimepiride. On 07 Jan 2021 at 08:05, approximately 20 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection. On 07 Jan 2021, 20 minutes after receiving the vaccine, the patient felt palpitations. She checked her blood sugar due to her being diabetic, which was okay. The palpitation was going faster, her chest and neck were red, and she felt like she was choking from the palpitation. The patient returned to where the vaccine was administered where her heart rate was found to be 130 and her blood pressure was 200/109. She had small pin-point rashes on both arms. She was taken to the emergency on 07 Jan 2021 where she had blood work done, and she was given 500CC of normal saline and was released the same day. The rashes on her arms faded on Thursday (07 Jan 2021), and her left arm in the evening was so stiff up to her elbow. She also developed a lymph node in her left armpit. Her temperature was 100.2 on 08 Jan 2021 and she took a paracetamol. The patient had body aches and a headache starting on Friday (08 Jan 2021) up until Saturday (09 Jan 2021). Treatment for the events included 500CC of normal saline and paracetamol. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events palpitations, blood pressure was 200/109, heart rate which was 130, chest and neck was red, left arm in the evening was so stiff up to her elbow, developed a lymph node in her left armpit, and temperature on 08JAN2021 was 100.2 was unknown. The event rashes on both arms was considered recovered/resolved on 07 Jan 2021, and the events body aches and headache were considered recovered/resolved on 09 Jan 2021.; Reporter's Comments: This spontaneous report refers to a case of a 62-year-old female patient with medical history of diabetes, who experienced serious events of palpitations and blood pressure 200/109 and non-serious events of heart rate was 130, chest and neck was red, rashes on both arms , left arm in the evening was soo stiff up to her elbow, body aches, lymph node in her left armpit, and headache 20 minutes after the administration of the first and only dose of mRNA-127 (Lot number unknown, Exp date-unknown). Normal saline was administered, and the patient was released the same day The patient also experienced elevated temperature of 100.2, 1 day after vaccine administration. Based on temporality and the absence of any other etiology factors, a causal association between the events and vaccine administration cannot be excluded
62 2021-01-26 fast heart rate Metallic taste post injection Fever 102 degrees (by 8pm eve of shot) Tylenol only reducing fever to ... Read more
Metallic taste post injection Fever 102 degrees (by 8pm eve of shot) Tylenol only reducing fever to 101 Severe chills/shakes Insomnia Confusion Dizziness Tachycardia (125 bpm) persistent the first night) Loose stools Incontinence
62 2021-01-27 blood pressure increased, heart rate increased Started 1/11/21 at work. I am a medical professional. Left arm tingling and numbness. Floaters and f... Read more
Started 1/11/21 at work. I am a medical professional. Left arm tingling and numbness. Floaters and flashers mostly in left eye. Scattered ones in right eye. Elevated blood pressure 147/79 (normal for me near 120/70) Pulse 106. My normal is in 60's. R:20 POX: 95% RA. Worked full shift 2P-10:30PM. Got good night sleep. Still had symptoms on 1/12/21 so went to urgent care. I still have these symptoms.
62 2021-01-27 loss of consciousness About 9PM after the receiving the vaccine I started had riggers which lasted for about an hour. I co... Read more
About 9PM after the receiving the vaccine I started had riggers which lasted for about an hour. I couldn't reach for my phone or call for help. I either passed out or fell asleep. Around 1AM I woke up and checked my temperature 102.7. Some point after I took some Tylenol but don't remember when. I finally had to call for help from my family in the morning because I was not able to pee or drink. Tuesday was my fever was still 102.7 with taking Tylenol and Advil it would just go back up. Tuesday I had Riggers again about 5:30 it only lasted 3-5 minutes. Wednesday my fever went down to 101.4-101.5. Have had difficulty swallowing when the fever is high, did not feel as if I had a allergic reaction or that my throat was sore it was just hard to swallow. I have a weird bruise on my arm I have clue where I got it. I didn't urinate for 9 hours. Headache. Pulse OX was at 93-94 for Monday and Tuesday but then it came it up 95-98 yesterday. As of today I still pretty weak no fever when I woke up.
62 2021-01-28 heart rate increased Awoke at 11pm from a sound sleep feeling unusual but unable to identify anything specific. Checked m... Read more
Awoke at 11pm from a sound sleep feeling unusual but unable to identify anything specific. Checked my O2 saturation with my pulse ox and was 76% with a heart rate of 122. Used my rescue albuterol inhaler which I haven't used since October (Fall and Spring are my typical times when I need albuterol inhaler and then not regular use.) Waited 15 mins with no change. Took a nebulizer treatment of albuterol. After 30 minutes was getting O2 saturations in the 80's. With deep breaths after an hour got a reading of 96% but wasn't consistently staying in the 90's. Fell back asleep around midnight and awoke feeling ok. I did not feel SOB when my saturation was at 76%, but my pulse was elevated to help compensate.
62 2021-01-28 fainting SARS-CoV-2 test positive; Faints; Chills; Headache; A spontaneous report was received from a consum... Read more
SARS-CoV-2 test positive; Faints; Chills; Headache; A spontaneous report was received from a consumer concerning a 62-year-old, female patient who received Moderna's COVID-19 vaccine and experienced faints, headache, chills, and COVID-19. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 30 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) in the right arm for prophylaxis of COVID-19 infection. On 30 Dec 2020, prior to vaccination, the patient took a COVID-19 test and results were negative. On 31 Dec 2020, the day after vaccination, the patient got instantly sick, she had a headache, chills, and faints. On 03 Jan 2021, the patient went to the emergency room (ER) where she received unspecified treatment for the symptoms she was experiencing. On 04 Jan 2021, the patient received a second COVID-19 test and received a positive result on 08 Jan 2021. On 08 Jan 2021, the patient was hospitalized with reported COVID-19 symptoms of dehydration, cough, no appetite, and no taste. Treatment for the event included fluids, oxygen, and steroids. On 11 Jan 2021, the patient was discharged from the hospital. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, faints, headache, chills, and COVID-19, was not reported.
62 2021-01-28 fainting Patients daughter reported that the patient had a swollen tongue, swollen throat, swelling in her fa... Read more
Patients daughter reported that the patient had a swollen tongue, swollen throat, swelling in her face and fainted. This was after treatment at home - unknown how much time had passed after vaccination. Patient received a dose of their own Epipen. Patient had consented to the vaccination and had received the VIS
62 2021-01-29 chest pain For my 2do vaccine: 01/27/2021 at night started arm pain, a little headache, and chest pain at the ... Read more
For my 2do vaccine: 01/27/2021 at night started arm pain, a little headache, and chest pain at the same level of my arm . Looks as the pain came from my arm and get on my chest. the pain was not too bad except it was on my chest all the time. The next day, I went to the airport at 6 am and came back home 07:30 am, my arm was not to bad , but the pain on my chest was situated in one place and the same, on the right side beside of sternum, under of the 5st ribs.
62 2021-01-30 fast heart rate Allergic reaction occuring 4 hours after #2 dose of Moderna: symptoms were sudden onset of flushing,... Read more
Allergic reaction occuring 4 hours after #2 dose of Moderna: symptoms were sudden onset of flushing, tachycardia, swelling of lower lip and feeling of need to clear throat due to sensation in throat. Took Benadryl at home due to edema of lip and feeling the need to clear throat.
62 2021-01-31 blood pressure decreased 15 minutes after shot, My chest felt warm. The 2 medics took me in a wheelchair to have my vitals t... Read more
15 minutes after shot, My chest felt warm. The 2 medics took me in a wheelchair to have my vitals taken. My blood pressure was 218. I was given fluids and monitored for 30 minutes. They took my BP again and it was 198. I was sent home and told to monitor my vitals and report to my family care doctor.
62 2021-01-31 chest pain Patient received their first dose of Moderna vaccine on 1.21.2021. Patient reported redness, warmth,... Read more
Patient received their first dose of Moderna vaccine on 1.21.2021. Patient reported redness, warmth, and swelling at the injection site on 1.29.21 (8 days) after the first vaccine. Patient states they took benadryl and as of 2.1.21 have seen improvement. Patient also reports that at 7pm on 1.29.21 they experienced non-cardiac chest pain (pain 8 out of 10) that was sharp and felt like muscle pain. Patient is a podiatrist, so took aspirin, monitored vitals, vitals stable. Patient says the chest pain lasted approximately 7 hours.
62 2021-02-02 chest discomfort At 18:20 on 02/03/2021 Patient received Moderna Vaccine 0.5ml in Right Deltoid. At approximately 18:... Read more
At 18:20 on 02/03/2021 Patient received Moderna Vaccine 0.5ml in Right Deltoid. At approximately 18:23 patient began complaining of shortness of breath and chest tightness. Assessment of patient showed a heart rate of 116 and SPO2 reading of 89. Patient was place on 2L/hr of oxygen via nasal cannula and encouraged to take deep breaths. Patient stated that " she felt like her throat was closing and she was going to pass out". After noting hoarseness in her voice LPN administered 0.3 Epinephrine via auto-injector and 911 was dialed. Patient was transported by ambulance at 18:35 hrs to Hospital.
62 2021-02-02 palpitations I had body aches, fatigue, and heart palpitations. I needed up at the emergency room because the he... Read more
I had body aches, fatigue, and heart palpitations. I needed up at the emergency room because the heart palpitations were bad. After extensive tests they found no heart issues. ER doctor said it was reaction from the vaccine.
62 2021-02-03 heart flutter, palpitations Heart flutter and racing, shaky all over, unsteady on feet, tongue not moving right, speech weird, ... Read more
Heart flutter and racing, shaky all over, unsteady on feet, tongue not moving right, speech weird, 158/80, 135/75 Heart rate: 100
62 2021-02-03 chest discomfort tight chest fever headache weakness
62 2021-02-04 chest pain, chest discomfort Anaphylactic reaction; A spontaneous report was received from a 62-year-old, female patient, who rec... Read more
Anaphylactic reaction; A spontaneous report was received from a 62-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction. The patient's medical history, as reported, included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome. On 24 Jan 2021, about 15 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 24 Jan 2021, 30 minutes prior to receiving the vaccine, the patient took prednisone (dose unknown), per instructions from her doctor due to her history of anaphylactic reactions. She did notify the vaccinators of her history and there was an ambulance present. About 15 minutes after receiving the vaccine, the patient started coughing, had heavy chest pain, trouble breathing, and felt like her throat was constricting more than usual. No rash developed. She approached the ambulance and asked if she could take diphenhydramine. She took one dose, followed by 3 other doses, and felt a bit better. Consent given for Safety to follow up with patient. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, anaphylactic reaction was resolving at the time of this report.; Reporter's Comments: This case concerns a 62 year old female patient with medical history of included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome. She experienced a serious unexpected event of Anaphylactic reaction that needed treatment diphenhydramine. The event occurred approximately 15 minutes after first dose of the study medication administration even thought the patient took prednisone prior to receiving the vaccine. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
62 2021-02-05 chest discomfort, chest pain Immediate redness in arm at injection site, tender to touch, swollen and hot. Day after vaccine- ... Read more
Immediate redness in arm at injection site, tender to touch, swollen and hot. Day after vaccine- severe chest pains and stomach pain lasting for 4 days. Heaviness on chest. Blood pressure was OK. Random stabbing in foot as if someone put a needle in the top of the foot. All of which is now gone. Feb 4, approx 1 week after injection, there is about a hard lump at needle site. Pt describes a similar to mosquito bite, very itchy. Red area of skin approx 2 inch diameter, visible raised lump hot to the touch
62 2021-02-07 blood pressure increased, chest discomfort, heart rate increased My right arm was painful at the injection site for 3 days after the vaccination. Then on Wednesday,... Read more
My right arm was painful at the injection site for 3 days after the vaccination. Then on Wednesday, February 3, 2021 about 3:45pm I experienced shortness of breath and some chest discomfort. At approximately 6:00pm, I felt a strong pulsating at my left temple which continued through the night. I took my blood pressure and it was 150/90 and pulse was 103 which is the highest reading I have ever had because I am on blood pressure medication. I took 2 aspirin, my Proventil Inhaler, and another Losartan 50 mg even though I had already taken my daily dose in the morning. I rested and continued to monitor my vitals. At about 11:30pm, I took my blood pressure and it was 160/110 and pulse was 109. I then took 2 more aspirin and my Clonazapem and fell asleep. In the morning on February 4, 2021, I tried to get in to see my doctor, but she advised to go to the emergency room. I went to an Urgent Care facility and the checked me and did an EKG and that was normal. But they also advised me to go to the emergency room. So I did go and they did another EKG, chest x-ray, and several blood tests. They came back normal but they wanted me to stay overnight for observation. On February 5, 2021 they did an echocardiogram and a stress test, which were normal. I was released from the hospital that afternoon. I have a follow up appointment with my Primary Care Physician on February 12, 2021. My blood pressure and pulse continue to be a little higher than normal. At this point, the pulsating, shortness of breath, and chest discomfort have improved. On Saturday, February 6, 2021, I noticed felt itchiness, redness and swelling at the injection site on my right arm. It is still itchy, red and swollen as of February 8, 2021. I am putting hydrocortisone cream on it.
62 2021-02-08 heart rate decreased, heart rate increased initial symptoms started at ~ 8-12 hr post inj on FRI: fever, chills, fatigue, muscle pain (general... Read more
initial symptoms started at ~ 8-12 hr post inj on FRI: fever, chills, fatigue, muscle pain (generalized), back pain from sacrum to occiput, through cranium to behind eyes, nausea, loose stools, exhaustion, arm swelling (6" diameter) with bandaid indented becoming hard (feeling a little like cellulitis). routinely measure pO2 and body temp--both spiked; resp rate went from normal pattern of 10-12 to 25; night time HR went from low 60's to the 100's; pO2 went from 96-98 to 89-91 (Innovo PulseOx)Treated with sleep (slept from 8PM night of shot until 48 hours after the shot), fluids, hot water bottles, arnica (I can't take NSAIDS), vit C, zinc megadoses; by ~36 hours post injection I started wheezing and coughing deeply but non productive, both nasal passages were/are open, feels as though phlegm is stuck at bronchi. By 48 hours, I was feeling better except chest, ribs, head, and neck and was experiencing 1-3" episodes of spasmodic coughing, wheezing, SOB; Occurred every 20-30 minutes and leaving me physically exhausted. Sunday night slept with 4 pillows; went to see acute respiratory care clinic, evaluated, COVID-PCR was negative, temperature was normal by statistics (I tend to be colder; baseline temps between 32-33oC and over past week has ranged between 35-39oC). Sent home with albuterol inhaler, mucinex (which I take at night), and flonase (my nostrils remain clear). Current status: extreme fatigue, high resting HR, minimal activity (walking) increases it to the 100s--not normal for me), and continued episodic bronchospasm (uncontrolled) with SOB and diaphragmatic, skeletal pain. Deep diaphragmatic breaths also trigger. Am also treating with hot water bottles to anterior and posterior chest walls, and nebulizer treatments with eucalyptus, thyme, and rosemary. Still megadosing on C and Zinc. Expect to return to work tomorrow (missed 2 days) as neurologic and orthopedic physical therapist /exercise physiologist.
62 2021-02-08 palpitations Systemic: Other- Eye quivering, heart raced, quickly returned to normal-Mild
62 2021-02-09 palpitations She called the health department with questions about receiving the 2nd dose. The initial reaction o... Read more
She called the health department with questions about receiving the 2nd dose. The initial reaction occurred during monitoring after the vaccine, her heart was racing and she had a hard time catching her breath. After nourishment and the end of the monitoring she felt better and was able to drive home. On 1/11/2021, 4 days later, she was sitting and started feeling hot inside. Her left chest and left arm became numb and tingly. She went to the ER within 30 minutes of onset. After the examination she was told the reaction was likely a side effect from the vaccine. The numbness and tingling remained most of the day and she felt better the next morning and has had no other episodes.
62 2021-02-11 fainting At 2pm I was at work and packed my things like I was going home. A friend saw me and told me it wasn... Read more
At 2pm I was at work and packed my things like I was going home. A friend saw me and told me it wasn't time to go home. At this time she took me to my office and I realized I was confused. When I got home on the 3rd of February I had a fainting spell. I had headache on the left parietal and temporal lobe. The headache was the worst headache of my life. It lasted for 7 days. It was throbbing and pulling constantly. It felt better when I was sleeping. The left side of my head was warm. Upon waking up, my headache would return. On day 7 all symptoms resolved. I went to my physician (Via phone visit) and she has ordered me an MRA w/o contrast head which is now pending.
62 2021-02-14 heart rate increased 5 minutes after the shot I felt a rapid heart beat that lasted about 5 minutes and then subsided Whe... Read more
5 minutes after the shot I felt a rapid heart beat that lasted about 5 minutes and then subsided When I left the site my face was very flushed and I had a small red mark on my check, from the flush, that subsided quickly too Although I understand this is not a substantial reaction and it did resolve I am a little concerned about what to expect from the second shot. Can you tell me if this is a common reaction? I really want to know about people who complained about this and then received the second shot, what was their reaction then. Thank you so much
62 2021-02-15 fainting Syncope after getting vaccine
62 2021-02-17 chest discomfort Swelling of tongue, medicinal taste, burning in nostrils following the vaccination. Next day headach... Read more
Swelling of tongue, medicinal taste, burning in nostrils following the vaccination. Next day headache, confusion in speech and thinking, constricted breathing in throat and chest, fatigue.
62 2021-02-18 chest discomfort Client reported she had some chest tightness for a little bit prior this Rn approached her. She says... Read more
Client reported she had some chest tightness for a little bit prior this Rn approached her. She says she feels better now however this RN noticed she was sweating. Client was helped to a flat position, BP checked: 120/80, HR 74 regular and strong pulse. RR 16 lung sounds clear, O2Sat 98. This Rn offered a juice client refused said she ate prior coming and she is prediabetic. Had pt rest for about 10 minutes. She reported feeling better afterwards and she was no longer sweating.
62 2021-02-18 chest pain, blood glucose increased Patient began having feelings of sternal chest pain, acute onset of cough, feeling warm throughout b... Read more
Patient began having feelings of sternal chest pain, acute onset of cough, feeling warm throughout body, and c/o headache after approximately 25-30 min after administration of vaccine. patient was on 30 min observation for previous hx of penicillin allergy. RN obtained vital signs, called for MD assistance, obtained blood sugar, gave baby aspirin per MD's order, called 911 for transport to ED to r/o possible MI, patient refused 911 assistance AMA signed for paramedics patient drove away from clinic for refusal of treatment
62 2021-02-19 heart rate increased 1st shot days after got rash from head to toe. 2nd shot 16 hrs after vaccine got severely ill. Fatig... Read more
1st shot days after got rash from head to toe. 2nd shot 16 hrs after vaccine got severely ill. Fatigued, Nausea, & Vomiting, fever 100.6, headache, chills body aches, wheezing, heart rate rapid. Day after better but still nausea and fatigued for the 3 days, mild headache.
62 2021-02-22 heart flutter Heart flutters , sore arm , trouble sleeping
62 2021-02-23 blood pressure increased Patient had generalized anxiety disorder after vaccination . Onsite EMS was called vitals BP 195/105... Read more
Patient had generalized anxiety disorder after vaccination . Onsite EMS was called vitals BP 195/105 100% O2 room air HR 79. Patient Refused Evaluation/Care released against medical adive.
62 2021-02-23 palpitations Rapid heart rate which lasted pretty much all day, stronger than normal heartbeat, chills with temp ... Read more
Rapid heart rate which lasted pretty much all day, stronger than normal heartbeat, chills with temp of 96.2.
62 2021-02-24 blood glucose increased 5 minutes - severe flushing on face/chest and headache, 45 mins - sneezing, 1 hour - itching, chills... Read more
5 minutes - severe flushing on face/chest and headache, 45 mins - sneezing, 1 hour - itching, chills, 2 hours to 24 hours - continued headache, chills, high fever (102), body aches, nausea, fatigue, stiff joints, tingling lips and tongue, difficulty swallowing, wheezing, MS symptoms, very high sugar levels (450 - out of normal range), began to subside in severity after 24 hours but was out flat for 4 days before feeling better, occassional bouts of chills and itching as well as ongoing need to sleep continued for over a week, huge raised swollen area appeared at injection site - from shoulder to elbow, very hot - used a cold pack to help reduce swelling. Throughout all of this, used large amounts of Benadryl, Advil, Albuterol, drank lots of fluids, used emergency insulin, and had Epi-Pen on hand.
62 2021-02-24 blood pressure increased Described previously-took OTC medication
62 2021-02-24 blood pressure increased History of controlled HTN for 13 years. Received second Covid 19 vaccine on 1/28/21 and on 2/1/21 bl... Read more
History of controlled HTN for 13 years. Received second Covid 19 vaccine on 1/28/21 and on 2/1/21 blood pressure was registering in the 180's over 90's and even after an increase in blood pressure medication, Losartan, blood pressure continues to increase. Took Losartan 25mg once a day for 13 years and on 2/23/21 increased to Losartan 50mg twice per day. Blood pressure today 2/25/21 is 187/11.
62 2021-02-24 chest pain SEVERE weakness in legs and arms. SOB, headache, neck weakness, twitching, jerking, uncoordinated, d... Read more
SEVERE weakness in legs and arms. SOB, headache, neck weakness, twitching, jerking, uncoordinated, dizzy, hardly able to walk, mind fog, chest pain.
62 2021-02-24 heart rate increased Rapid heart rate, chills, aches, sweats and severe depression.
62 2021-02-27 palpitations, fast heart rate Systemic: see below-Medium, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Medium, Systemic: T... Read more
Systemic: see below-Medium, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild, Additional Details: prior to vax, voiced anxiety re: coming outside house for vax (reports not having left home since 3/2020). Reported h/o severe cardiac palpitations & possible swelling w/lidocaine, so instructed to wait 30 min obs post-vax (vs standard 15 min). Recieved vax w/o issue. Around 20 min into obs time, reported heart racing, anxiety w/ shakiness in arms. Eval'd by in-store NP; paramedics contacted. Fully cleared; normal BP, HR 100, clear lungs. Pt declined transport to hosp & left w/daughter
62 2021-02-28 palpitations 1:05 pm Post vaccination reports "feeling anxious w/palpitations"; medical monitoring x 30 min, BP 1... Read more
1:05 pm Post vaccination reports "feeling anxious w/palpitations"; medical monitoring x 30 min, BP 109/72 P69 O2 sat 98%RA No additional complaints / symptoms reported; released from facility to home.
62 2021-03-01 blood pressure decreased Patient experienced dizziness and felt hot immediately after injection. Her injection site bled and ... Read more
Patient experienced dizziness and felt hot immediately after injection. Her injection site bled and required multiple bandaids and pressure held on area. During this, she felt like she was going to pass out. We provided a cold compress and water. I checked her blood pressure and she reported it being lower than normal (120/82). I re-checked in 5 minutes and it continued to drop to 105/65. I asked the patient if she would like us to call for additional medical attention to be evaluated and she said 'yes'. We called 911 and EMS arrived on the scene to further evaluate. Prior to EMS arrival, the patient's blood pressure was 130/90. The patient's blood pressure returned to normal about 30 minutes after injection and she did not go to the hospital.
62 2021-03-03 chest pain Patient received vaccine at 2:15 PM, and around 9:00 AM, she noticed chest pain, lymph node swelling... Read more
Patient received vaccine at 2:15 PM, and around 9:00 AM, she noticed chest pain, lymph node swelling, generalized aches, headache (front and back of head), fever, vomiting, chills. Side effects were severe. Patient stated she had covid-19 infection during November 28, 2020. Patient received first Moderna dose on 3/3/2021
62 2021-03-03 heart rate increased increasing rapid heartbeat within 60 minutes of the vaccine. Resting heartbeat 145
62 2021-03-04 blood glucose increased headache, fatigue, high blood sugars
62 2021-03-04 palpitations Patient reported feeling "dizzy", "heart racing", and "jitter" approximately 15 minutes after inject... Read more
Patient reported feeling "dizzy", "heart racing", and "jitter" approximately 15 minutes after injection. No other reported symptoms. Vital signs stable; HR 78, BP 123/81, 100% oxygen on room air. Patient noted to be extremely anxious, not able to sit still in chair. Remained in room with patient for 15 minutes, talked with patient, and provided her water. Patient monitored in room for 45 minutes, felt much better at this time and discharged at 2:02 pm. States she did not take her lorazepam today.
62 2021-03-04 palpitations 5 minutes after the injection I got hot and my heart started racing. My throat felt tight. This feel... Read more
5 minutes after the injection I got hot and my heart started racing. My throat felt tight. This feeling dissipated after 5 minutes.
62 2021-03-05 chest discomfort following the Moderna COVID-19 Vaccine EUA: at around 6:00 PM I began experiencing a headache and s... Read more
following the Moderna COVID-19 Vaccine EUA: at around 6:00 PM I began experiencing a headache and some soreness in my left arm around the shot site and became very tired, then around 10:00 pm nearly half my joints began aching. After waking, I still had a headache and body aches, but felt somewhat better. by 1:00 pm, became very achy in my joints again and tired. I had 2 times during that evening lasting about 5 to 10 minutes each of difficulty breathing and a slight tightness in my chest. This passed and I did sleep better the night of 3/5/21.
62 2021-03-05 palpitations, heart rate increased Fast pounding heartbeat for 12 hours, left leg calf felt tingly, felt like someone was squeezing my... Read more
Fast pounding heartbeat for 12 hours, left leg calf felt tingly, felt like someone was squeezing my throat briefly twice. That Went away within 2 minutes
62 2021-03-06 blood pressure increased A week after the shot my blood pressure spiked and has not gone down yet. It was well controlled bef... Read more
A week after the shot my blood pressure spiked and has not gone down yet. It was well controlled before the shot. I have been to the emergency room twice and to the cardiologist. No meds are working.
62 2021-03-07 hypertension, chest pain High blood pressure; chest pain; back pain; numbness in limbs; nausea and vomiting.; inability to wa... Read more
High blood pressure; chest pain; back pain; numbness in limbs; nausea and vomiting.; inability to walk or move legs and feet. Was officially diagnosed on 2/5/2021 wit Acute Sensory Axonal Neuropathy a severe/rare case of Guillain-Barre Syndrome. Unknown time for recovery. Is in the process of being referred to a rehab center.
62 2021-03-07 palpitations, palpitations, palpitations Client started experiencing difficulty breathing and racing heart beat on 03/03/21 and lasted for 2 ... Read more
Client started experiencing difficulty breathing and racing heart beat on 03/03/21 and lasted for 2 days. Client is diagnosed with carpal tunnel on both hands and is receiving cortisone injection. Currently, right hand is throbbing and left hand is partially numb. Client plans on following up with provider regarding symptoms.
62 2021-03-08 heart rate increased Rapid heartbeat Body Aches Fever Extreme shaking Headache Fever
62 2021-03-09 blood pressure increased, heart rate increased My normal heart rate is around 72 beats per minute. I received the vaccine at 12:30pm on Monday 03/0... Read more
My normal heart rate is around 72 beats per minute. I received the vaccine at 12:30pm on Monday 03/08/2021. I did not seem to have any reactions to the injection. Two hours later, I happened to have an annual check up with my cardiologist. At that time, my vitals were taken and my heart rate was 113 bpm. I told the doctor that I just had the vaccine. He said that if it did not go down by that night or the next day, to get it checked. On Tuesday, my pulse had went down to the mid 80's/low 90's, so I thought it was improving. When I woke up today, Wednesday, 03/10/21, my pulse had gone up to 103-104 and my blood pressure was somewhat elevated, so I attempted to get an appt to see my primary care doctor, but she was out so I saw her associate, Dr . At this visit, my pulse was 98-99. She did not think that it was an allergic reaction, but that it was a side effect of the vaccine. She had no idea how long it might last, and just told me to monitor it and if it became increasingly elevated to seek help.
62 2021-03-09 palpitations Chills, severe headache, fever (101-103) , fatigue, throwing up, nausea, heart palpitations and COVI... Read more
Chills, severe headache, fever (101-103) , fatigue, throwing up, nausea, heart palpitations and COVID Arm Rash. (still have rash)
62 2021-03-10 chest discomfort Patient received her 1st dose of the COVID vaccine and during the observation she began to feel thr... Read more
Patient received her 1st dose of the COVID vaccine and during the observation she began to feel throat swelling and tongue swelling. She also noticed some pressure in her chest with shortness of breath. She was assessed by staff in the area and was given IM epinephrine 0.3mg for an allergic reaction and was transported to the emergency room for further treatment and observation. given diphenhydramine 50mg IV, famotidine 20mg IV, methylprednisolone 125mg IV.
62 2021-03-11 palpitations Moderna first dose.. At first I just had a few heart palpatations and felt off. After 3 days I woke ... Read more
Moderna first dose.. At first I just had a few heart palpatations and felt off. After 3 days I woke up with pain in my right side and down leg. I then got a rash on my right butt cheek. Turned into Shingles. I have had shingles in the past but it was over a year ago.
62 2021-03-12 loss of consciousness Nauseous chills sweats headache and passed out
62 2021-03-13 palpitations, blood pressure increased Pt. experienced flushing, itching, throat tightness, increased B/P and heart palpitations. Given 50 ... Read more
Pt. experienced flushing, itching, throat tightness, increased B/P and heart palpitations. Given 50 mg. Benadryl IM. Sent to ED for observation.
62 2021-03-14 heart rate increased Day 1 soar arm, day 2 fatigue, day 3 stomach pain diarrhea (lasting 10+days) day 4 congestion mild ... Read more
Day 1 soar arm, day 2 fatigue, day 3 stomach pain diarrhea (lasting 10+days) day 4 congestion mild headache light headed dizzy runny nose ( still have 10 days later} unable to function normally, spending most of the last 8+ days in bed. Day 13 racing heart day 14 itchy skin and blotches on my arm knees back and butt. (took some benadryl and put anti itch cream on. that resolved overnight). Day 15 I am still light headed very fatigued.
62 2021-03-14 heart rate increased A few minutes after the injection the patient reported a heart rate of 100 bpm being reported on her... Read more
A few minutes after the injection the patient reported a heart rate of 100 bpm being reported on her active watch. A few minutes later her heart rate had returned to her normal range. Patient did not feel dizzy or light headed and wanted to go home Patient was advised to consult an allergist for a recommendation to receive or not receive the second Moderna COVID vaccine.
62 2021-03-15 nosebleed, hypertension On the second day after the vaccination I experienced a strong pain/pressure behind my right knee. ... Read more
On the second day after the vaccination I experienced a strong pain/pressure behind my right knee. I thought that a walk would help it but the 50 minute walk did not lessen the pain and my gait was strongly affected. My blood pressure was way up that day 175/101 and I also had a slight nose bleed. I never limp and yet I did the entire day! I woke up the next day and everything was fine.
62 2021-03-16 chest discomfort external itchiness on neck. chest tightness
62 2021-03-16 chest discomfort itchiness on outside skin of throat. chest tightness
62 2021-03-16 chest pain, chest discomfort 30 to 60 minutes after the vaccine I started to feel extremely tired, woke up in the middle of the n... Read more
30 to 60 minutes after the vaccine I started to feel extremely tired, woke up in the middle of the night with low grade fever of 100 and chills (sweating).Also had pain in my left arm from my elbow up into my neck. Up and down all night. 6:30AM felt nauseous and dizzy. Could not drive to work. So tired I slept most of the day. 3/17/21 Left work at lunch for home. Continued pain in arm & neck, very tired, pressure (achy) in chest .
62 2021-03-16 loss of consciousness Slight swallowing 40 minutes post first vaccine. Seven and a half hours later, nausea, cold sweat, a... Read more
Slight swallowing 40 minutes post first vaccine. Seven and a half hours later, nausea, cold sweat, and momentarily blacked out.
62 2021-03-17 blood pressure increased Sudden elevation in blood pressure running 212/110. This requires two ER visits with elevated BMP ca... Read more
Sudden elevation in blood pressure running 212/110. This requires two ER visits with elevated BMP cardiac bloodwork and elevated urine protein. Cardiologist added two additional medications and then referred to hypertensive kidney specialist because they could not get under control. Now on three medications to control blood pressure
62 2021-03-17 chest pain Light headedness and chest pain shortly after 2nd dose of Moderna vaccine
62 2021-03-18 blood pressure increased Took Tylenol. Felt achy, tired, couldn't move. Headache. Neck and back pain, high blood pressure.
62 2021-03-18 cerebrovascular accident Patient received 1st dose of Moderna vaccine on 01/30/2021. Patient received second dose on 2/27/20... Read more
Patient received 1st dose of Moderna vaccine on 01/30/2021. Patient received second dose on 2/27/2021 and within an hour noticed slurred speech and drooped face. Patient went to ER and was transferred to another Hospital on 2/27/21 due to stroke. Now patient believes stoke may have started 2/26/21, as she was somewhat confused that day, but didn't realize stroke until after vaccine.
62 2021-03-18 chest discomfort Started approximately 8 hours after vaccine given. Extreme weakness, fatigue, sore throat, cough, c... Read more
Started approximately 8 hours after vaccine given. Extreme weakness, fatigue, sore throat, cough, chest issues, severe headaches, feverish, and mostly incapacitated for 2 days. Her family members had to take care of her. After 48 hours she was mostly back to normal. called today for guidance and was advised to seek medical attention/advice from her PCP.
62 2021-03-18 fast heart rate Headache, weakness, tachycardia, dark urine color
62 2021-03-19 chest pain 3/19/2021 horrible chest pains hard to breath Itching all over my body Right eye lid red and swollen... Read more
3/19/2021 horrible chest pains hard to breath Itching all over my body Right eye lid red and swollen 3/20 4-5:00 am up sitting in the side of the bed . Very uncomfortable to lay down can?t breathe properly Taking pantoprazole again 3/19- 9:00 pm 3/20- 9:05 am 3/20 - 9:04 blood pressure 130/87 9:15 am extreme itching and rash on both arms Took a warm bath felt horrible. Took temperature 100.5 Main concern is breathing
62 2021-03-20 heart rate increased, heart rate irregular I was really nervous about getting the vaccine. I received the shot at 3:40pm and waited at the sit... Read more
I was really nervous about getting the vaccine. I received the shot at 3:40pm and waited at the site for 15 minutes, and I was feeling good, so I went home. I had dinner around 7:00pm. It was around 8:30pm when I was standing at the kitchen sink doing the dishes and I felt a wave wash over me and the rapid heart beat started. I immediately took Metoprolol since I usually take it around 9:00pm, and my heart rate went down some what. My heart beat is usually around 72. I didn't have my fit bit on, but I put it on after I took the medication and it was around 124, but I know it was much higher on the onset. It only lasted about 1 or 2 minutes. My heart beat was jumping around after that, I was scared, nervous, so I took a Xanax around 11:00pm. I slept through the night and had a normal heart beat in the morning.
62 2021-03-21 blood glucose increased, blood pressure increased - Elevated sugar level(300) with elevated BP(170/90) at ER same day after 8 hrs of vaccination. - ... Read more
- Elevated sugar level(300) with elevated BP(170/90) at ER same day after 8 hrs of vaccination. - Lab done from ER and discharge after 3 hrs in ER. - Advised to f/u with PCP. - Pt was seen at this clinic next day. The condition was stabilized.
62 2021-03-21 cerebrovascular accident Determined she had a mild stroke yesterday, March 21. Had slurred speech, could not form words, coul... Read more
Determined she had a mild stroke yesterday, March 21. Had slurred speech, could not form words, couldn't cook. Symptoms actually started on March 17th, one week after having the vaccine. She is currently hospitalized at hospital where she received her vaccination.
62 2021-03-21 heart rate increased Started on day 4 after vaccine. All over body rash on body felt like it was prickly and like it was... Read more
Started on day 4 after vaccine. All over body rash on body felt like it was prickly and like it was on fire or like a sunburn feeling, Increased resting heart rate 105 (my normal is around 68 to 75 resting). BP 156/73 ( my normal is 119/80) headache. Very shaky. Normal breathing O2 was 98 to 99.
62 2021-03-22 chest discomfort Patient received her 1st dose of the Moderna vaccine and during the observation. She began to feel ... Read more
Patient received her 1st dose of the Moderna vaccine and during the observation. She began to feel throat swelling and tongue swelling. She also noticed some pressure in her chest with shortness of breath. She was assessed by staff in the area and was given IM epinephrine for an allergic reaction. treated with methylprednisolone 125mg, famotidine 20mg, diphenhydramine 50mg. sent home with RX for prednisone 40mg daily for 5 days
62 2021-03-22 blood clot Patient reported the following: I went to the ER last Thursday because my left leg was red and swoll... Read more
Patient reported the following: I went to the ER last Thursday because my left leg was red and swollen. They did a sonogram and the results came back as tendentious and a superficial blood clot. The ER physician at Health suggested that I report the blood clot because it is of unknown origin and I did receive both vaccines.
62 2021-03-23 heart flutter 4 days after vaccine, had fluttering in chest while sitting watching tv. 5 days after vaccine had fl... Read more
4 days after vaccine, had fluttering in chest while sitting watching tv. 5 days after vaccine had fluttering in chest while on treadmill. 7 days after vaccine had fluttering in chest while dressing. Lasted few minutes. No SOB or chest pain.
62 2021-03-23 chest discomfort Severe muscle weakness, chills, burning eyes, dark orange urine, kidney pain, migraine headache, nau... Read more
Severe muscle weakness, chills, burning eyes, dark orange urine, kidney pain, migraine headache, nausea, chest heaviness but not short of breathe. 27 hours in bed except to go to the bathroom, weakness so severe it hurt my whole body to turn on my side.
62 2021-03-23 chest pain HPI: 62 yo with a "bad gallbladder attack" 20 years ago. She was sick for 2 weeks but had no insuran... Read more
HPI: 62 yo with a "bad gallbladder attack" 20 years ago. She was sick for 2 weeks but had no insurance and was treated conservatively. Her pain was principally in the R post. Flank. Since then she's has occasional mild attacks associated with the same flank pain and nausea. Two weeks ago last Friday while working at the post office, she became acutely ill with the same flank pain but this time also with epigastric and chest pain with nausea. She saw Dr. 4 days later and still felt lousey and then followed up on March 13. At that time the patient related the history as "The pain is described as aching, colicky, cramping and pressure-like, and is 5/10 in intensity. Pain is located in the RUQ, epigastric with radiation to right back. Onset was 4 days ago. Symptoms have been gradually worsening since. Aggravating factors: activity and eating. Alleviating factors: none. Associated symptoms: anorexia, belching, flatus and nausea. The patient denies fever, hematochezia, hematuria and melena." Subsequent blood work was normal including CBC, LFTs and lipase. US: A 1.9 cm shadowing gallstone is visualized. It is mobile. There is no gallbladder wall thickening or pericholecystic fluid. Patient reports right upper quadrant pain during the scanning. The common bile duct is normal in caliber measuring 2 mm. She remains fearful of eating. No CBD sx/signs. She's had one of two Covid vaccinations
62 2021-03-23 heart rate increased 30minutes after injection: Swelling lips, eyes, face , throat red face fast heartbeat dizziness fati... Read more
30minutes after injection: Swelling lips, eyes, face , throat red face fast heartbeat dizziness fatigue and headache next morning
62 2021-03-24 hypotension It was sent for low pressure on 02/12/2021 to the Hospital Medical Center. He died of respiratory ar... Read more
It was sent for low pressure on 02/12/2021 to the Hospital Medical Center. He died of respiratory arrest.
62 2021-03-24 fainting Patient felt hot and dizzy and had syncopal episode and vital signs BP 122/68, PR-86, SPO2-97. Blood... Read more
Patient felt hot and dizzy and had syncopal episode and vital signs BP 122/68, PR-86, SPO2-97. Blood glucose-129. EMS called and patient transported to hospital.
62 2021-03-25 blood pressure decreased BP fell with severe vomiting Fatigue, and inability to see because of spots in my eyes. Had to cra... Read more
BP fell with severe vomiting Fatigue, and inability to see because of spots in my eyes. Had to crawl to bathroom unable to walk
62 2021-03-25 chest pain Patient started to complain of numbness, tingling, and soreness to left chest radiating to left neck... Read more
Patient started to complain of numbness, tingling, and soreness to left chest radiating to left neck and left jaw about 5 minutes after vaccine was given. Was observed for 1 hr post vaccine. Denied chest pain or shortness of breath. No facial asymmetry noted. Full ROM to both arms. Hand grips equal. MD assessed patient.
62 2021-03-25 hypotension Almost exactly 24 hours after injection sudden onset profound fatigue, severe muscle joint aches, he... Read more
Almost exactly 24 hours after injection sudden onset profound fatigue, severe muscle joint aches, headache, hypersensitivity to sight & sound. Unknown if I was sleeping or hallucinating. Bizarre, vivid dreams. Don't know if febrile as I became dehydrated & hypotensive, was unable to transfer from lying to sitting to standing without near falling. Hadn'tfelt si profoundly ill since had Flu in 1988. Sxs lasted 8 hrs &completely gone. I do have preexisting IgA deficiency.
62 2021-03-25 fainting, cardiac arrest ? Maderna vaccine #1 on 3/16 at clinic ? Provider visit 3/22 dx bronchitis due to COVID-19, z pak an... Read more
? Maderna vaccine #1 on 3/16 at clinic ? Provider visit 3/22 dx bronchitis due to COVID-19, z pak and steroids ? ED 3/25 syncopy, full arrest and patient expired patient states she had COVID in February
62 2021-03-26 blood glucose increased Patient arrived to clinic for Covid immunization, received vaccine at 9:39 am in right Deltoid. Cal... Read more
Patient arrived to clinic for Covid immunization, received vaccine at 9:39 am in right Deltoid. Called to observation area 9:56 am by clinic case manager for patient report of "feeling funny" post immunization. Patient sitting upright with eye closed at table. Responsive to verbal stimuli and oriented to place and time. Patient complained of the following symptoms: trouble swallowing and "head rush" sensation. Patient was assisted back to exam room with bilateral two person support due to unsteady and slow gait. Eyes remained closed and patient required assistance to lay supine on the exam table. Speech slow and reported extreme feeling of fatigued. Vital signs at 9:58 B/P 118/72 left arm laying, HR 80. Blood Glucose 218. Patient is diabetic and reports she did take morning medications: Victoza 1.8mg, Lantus 60 units and Metformin 1 tab. Pulse ox 96%. 10:03 vital sign recheck 120/70 right arm (supine) with regular pulse in the 90's Complaints of feeling a burning sensation in body and reports very dry mouth with and jaw feeling strange (sensation much like before she has a seizure). 10:15 12-Lead EKG completed and reviewed by Dr who was present in room, no acute changes noted. Dr discussed need for patient to be sent to ER via EMS for further evaluation of vaccine reaction. EMS notified. 10:24 resting with eyes closed, reports ongoing fatigue and dry mouth. States that her "kidney's feel warm" and it "feels like my head is on fire", also states that her tongue has a burning sensation. Reports feeling like throat is "thick" 10:25 clear bilateral lung sounds,oral pharynx with no evidence of swelling. 10:32 Mild non-productive cough, remains with clear lung sounds bilaterally throughout, oral pharynx without swelling. 10:37: continues to report "burning sensation to back of head and neck", lips moistened with wash cloth for ongoing complaints of extremely dry mouth. 10:41: Resting with eyes closed, recheck vital signs, 116/72 right arm (supine), HR 95, 96%. EMS arrival, transported to hospital via EMS for further evaluation.
62 2021-03-27 chest discomfort Chills two hours 99-102.5 fever 36 hours Body aches 48 hours Headache 24 hours Tightness in chest 30... Read more
Chills two hours 99-102.5 fever 36 hours Body aches 48 hours Headache 24 hours Tightness in chest 30 minutes Sore arm ongoing Redness and warmth in arm 36 hours after vaccine Nausea 24 hours
62 2021-03-27 fainting Patient received first does of Moderna on left arm at 0900 on 03/27/21 in her vehicle. Soon after sh... Read more
Patient received first does of Moderna on left arm at 0900 on 03/27/21 in her vehicle. Soon after she felt dizziness, nausea, upset stomach and felty syncope coming on. Patient received medical attention and all vital signs were within normal range. Patient refused to go to hospital. Patient was with her daughter who assumed driving responsibility and would drive the patient home. Patient advised to stay additional time to monitor her.
62 2021-03-28 blood pressure increased RN: called AID for a guest complaints of "brain fog," and feeling her blood pressure was elevated. B... Read more
RN: called AID for a guest complaints of "brain fog," and feeling her blood pressure was elevated. B/P 142/78 when assessed. Guest reported a similar sensation when she received her first dose and this lasted for about four hours. Guest had some water B\P 140/78 rechecked and she states that she was fine and declined continued observation.
62 2021-03-29 atrial fibrillation 24 hours after vaccine, and 7 hours after onset of expected fever/chills/aches, triggered atrial... Read more
24 hours after vaccine, and 7 hours after onset of expected fever/chills/aches, triggered atrial fibrillation w/ RVR (130 BPM) with longest duration ever experienced - 3 days . Intent of this reporting is that patients with afib may need to choose a Covid vaccine that doesn't have the higher fever, flu symptom response as Moderna does, which could trigger the afib. Was about to need to visit ER to get converted to NSR, when self converted after 3rd day.
62 2021-03-29 heart rate increased 3/23 normal fatigue and arm pain, 3/24 woke up with body aches, 99 fever and it hurt to breath, betw... Read more
3/23 normal fatigue and arm pain, 3/24 woke up with body aches, 99 fever and it hurt to breath, between this day to the 27 there was an increase in pain in breathing, every breath it hurt. and still having pain breathing; I'm on a high dose of Prednisone
62 2021-03-29 heart rate increased Allergic Reaction - red rash on arm, tingly face and jaw, headache, racing heart rate
62 2021-03-29 heart rate increased received vaccine, pain and arm burn all the way to fingers. pain started day later, numb, both arms,... Read more
received vaccine, pain and arm burn all the way to fingers. pain started day later, numb, both arms, fingers hands, pain legs, bones shoulder cracking sound, snapping, hands and fingers freezing up in claw position, loss of strenght in arms , legs, hands, fingers, ankles pain, in joints and muscles, no sleep, headache, throbbing pain, sharp pain, not able to sleep, rapid heart beat, loss of strenght in hands and fingers, pain throbbing freezing hands, fingers unable to open hands, not go away, called docter, perscribed pain pills, still not go away, called docter subscribed sterioid, releived some but pain still there, pain now is back been till now 3/30/2021, progressively worse
62 2021-03-30 chest discomfort 3/16/21-Obtained vaccine at 0800. At 1pm same day, began with cough then an asthma attack, chest ti... Read more
3/16/21-Obtained vaccine at 0800. At 1pm same day, began with cough then an asthma attack, chest tights, couldn't catch breath. Required rescue inhaler and Advair inhalers. by 3pm same day, fever 100.3 po, severe body aches, horrible neck pain, extreme fatigue, ringing in ears, 'brain fog'. Went to bed 5pm- slept 7 hours. Woke up midnight, fever broke, still horrible aches and extreme fatigue. Slept another 7 hours. 0730 on 3/17 woke up face was "red" like a sunburn- no fever, very weak, no appetite. called primary, told to rest, tylenol, fluids and go to ED if worse symptoms. revisit in person 4/19. From 3/17-3/26 fatigue, brain fog- had eye exam for employment on 3/26 and vision in left eye had changed- could not see the chart. By today 3/31, still poor vision right eye- will see physician 4/2- less fatigue and improving brain fog, occasional tinnitus. This was my 1ST in the series of Moderna vaccines. Concern- should I get the 2nd on 4/13?
62 2021-03-30 heart attack Employee had a heart attack and past away around 3/17/21.
62 2021-03-30 pallor Tingling tongue, swollen tongue, swollen lips, small rash on upper arm near injection site and oppos... Read more
Tingling tongue, swollen tongue, swollen lips, small rash on upper arm near injection site and opposite forearm, tightening in throat, inability to swallow, difficulty breathing, unable to breathe, Inability to talk, pale, hoarse voice, intermittent cough,
62 2021-03-31 chest pain, fainting DAY2: POST SHOT PATIENT DEVELOPED 104 FEVER AND HAD SYNCOPAL EPISODE, DAY3: DEVELOPED VESICULAR S... Read more
DAY2: POST SHOT PATIENT DEVELOPED 104 FEVER AND HAD SYNCOPAL EPISODE, DAY3: DEVELOPED VESICULAR SORES IN NOSE DAY4: EXTREME ARM PAIN AND PAIN TO RIGHT SIDE OF CHEST WITH DEEP INSPIRATION AND COUGH DAY5: RIGHT SHARP EAR PAIN ALL DAYS EXTREME NAUSA AND GENERALIZED WEAKNESS, SEEN IN CLINIC ON DAY 7 POST SHOT
62 2021-03-31 inflammation of the heart muscle Myocarditis; Started having symptoms and typical symptoms; A spontaneous report was reported from a ... Read more
Myocarditis; Started having symptoms and typical symptoms; A spontaneous report was reported from a nurse (patient), concerning herself, a 62 years-old female patient, unknown race and ethnicity, was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced myocarditis, and started having symptoms and typical symptoms (vaccination complication). The patient's current condition included blood donor. Concomitant medications reported included acetylsalicylic acid, atorvastatin, and escitalopram. On 23 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 20 Jan 2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (batch number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection. The patient had nothing after the first dose and typical symptoms after the second dose. She started having symptoms on 07 Mar 2021. The patient was healthy and doesn't have any coronary disease. This was a red herring and stated that she was a blood donor and gave blood on Sunday, 07 Mar 2021. That's, the same day, the symptoms started. Also, the patient was a blood donor all last year. All the antibody tests were negative for last year and including the recent 07 Mar 2021 donation. This was outside the window of expected reactions, but she's been diagnosed with myocarditis, effective last week on 11 Mar 2021. The patient reported that the doctor started her on metoprolol tartrate 25 mg twice daily, which was started on 14 Mar 2021. Action taken with second dose of mRNA-1273 in response to the event was not applicable. The outcome of the events, myocarditis, and started having symptoms and typical symptoms were considered as unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information is requested.
62 2021-03-31 lightheadedness, fainting pt syncopal episode 20 minutes after COVID vaccination cold, clammy, AMS, convulsions improved with ... Read more
pt syncopal episode 20 minutes after COVID vaccination cold, clammy, AMS, convulsions improved with supine position, leg raised BP 98/68 norm per patient STAT BG 118 likely vasovagal transported to ER by EMS
62 2021-04-01 blood glucose increased Six hours after receiving my 2nd Moderna vaccine, my blood glucose (BG) levels began rise more than ... Read more
Six hours after receiving my 2nd Moderna vaccine, my blood glucose (BG) levels began rise more than usual. Since I'd just eaten dinner, I did not immediately deliver extra insulin. However, before going to bed, my BG level was even higher, so I delivered a corrective bolus using my Tandem insulin pump. I also use the Dexcom Continuous Glucose Monitoring System. Overnight, every time I woke up & checked my BG level, it was rising & rising, & so I continued to deliver corrective boluses. At 4:30 am this morning, I awoke, checked my BG level, & it was off the top of the graph on my pump; I used a fingerstick glucometer, & found that my level was 449, a dangerously high level. I delivered another corrective bolus, but my BG level would just not go down. I emailed my doctor, who instructed me to change my pump infusion site (I had actually done that about 5 hours following receiving the vaccine, but changed it again), delivered a 5-unit corrective bolus via syringe (shot) & checked my ketone level, finding that my ketones were extremely large, >160. I contacted the doctor's office again, & was instructed to consume a LOT of water, watch my BG level & check my ketones & inject 2- to 3-unit doses every hour. I did this all day today. By noon, my ketones had fallen to "negative" & my BG level had fallen to 169. It has continued to be a MAJOR struggle to keep my ketones in the negative range & my BG level anywhere near where it was prior to the Moderna vaccine. I don't know how long this will last, & I am AFRAID.
62 2021-04-01 chest pain, inflammation of the heart muscle A spontaneous report was received from a consumer concerning a 62-year-old, female patient who felt ... Read more
A spontaneous report was received from a consumer concerning a 62-year-old, female patient who felt like a needle in her kidney/renal pain, feve/pyrexiar, fatigue, tiredness/fatigue, chest pain, upset heart/cardiac disorder, headache and inflammation of heart muscle/myocarditis. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine, metformin, glimepiride, simvastatin, losartan. On 16 Mar 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 001B21A) intramuscularly for prophylaxis of COVID-19 infection. On 16 Mar 2021, 5 minutes later she experienced felt like a needle in her kidney. On 17 Mar 2021, she had fever. On an unknown date in Mar 2021, she had fatigue and tiredness. On 20 Dec 2021, she had chest pain and upset heart. On 21 Mar 2021, she had a headache and fever. On 22 Mar 2021 she had chest pain and went to the doctor and was diagnosed inflammation of the heart muscle. The event inflammation of the heart muscle was assessed medically significant. Treatment for the event included acetaminophen. Action taken with mRNA-1273 in response to the events was not provided. The events felt like a needle in her kidney was resolved on 16 Mar 2021. The events fever and headache were resolved on 21 Mar 2021. The outcome of the evens fatigue, tiredness, chest pain, upset heart and inflammation of heart muscle were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
62 2021-04-01 heart rate increased within 30 minutes of shot: dizziness, fast heart beat, hand shaking lasted 30-45 minutes, chills, la... Read more
within 30 minutes of shot: dizziness, fast heart beat, hand shaking lasted 30-45 minutes, chills, lasted 30 hours. in 24 hours: headache, congestion, left side of face--gums/teeth starting hurting, teeth got very sensitive. sore left arm. on going side effects as of March 28. Have lessened a little bit. as of March 30. side effects except teeth sensitivity has subsided.
62 2021-04-01 palpitations Sudden onset of frequent palpitations occurring over days
62 2021-04-02 cardiac arrest, haemoglobin decreased, platelet count decreased Please see patient information page
62 2021-04-02 heart rate increased, blood pressure increased throat was swelling; pain in jaw to ear; tongue was numb; could not feel her swallow reflex; blood p... Read more
throat was swelling; pain in jaw to ear; tongue was numb; could not feel her swallow reflex; blood pressure was elevated to 185/Unknown; pulse was 131bpm; aching and pain in throat area; shortness of breath; felt like the lymph nodes in her throat were achy; felt like the lymph nodes in her throat were swelling; chills; tiredness; This spontaneous case was reported by a consumer, who is a 62 year old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced throat was swelling, felt like the lymph nodes in her throat were swelling,felt like the lymph nodes in her throat were achy (Lymph node pain), pain in jaw to ear (Pain in jaw), tongue was numb (Hypoaesthesia oral), could not feel her swallow reflex (Hyporeflexia), blood pressure was elevated to 185/ unknown (Blood pressure increased), pulse was 131 bpm (Heart rate increased), aching and pain in throat area (Oropharyngeal pain), shortness of breath (Dyspnoea), chills (Chills) and tiredness (Fatigue). The patient's past medical history included No adverse event (No medical history reported). On 17 Mar 2021, 20 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 047A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 17 Mar 2021, the patient experienced felt like her throat was swelling, felt like the lymph nodes in her throat were swelling and achy, pain in jaw to ear, aching and pain in throat area, and chills. The patient went to the emergency room. While there, the patient's tongue was numb and she could not feel her swallow reflex, her blood pressure was elevated to 185/ unknown, pulse was 131 bpm. The patient was at the emergency room for 4 hours before the symptoms subsided. Treatment medications included prednisone for 3 days and Benadryl 50 mg every 6 hours. Since then, the patient was feeling shortness of breath and tiredness. The outcome of the events of felt like her throat was swelling, felt like the lymph nodes in her throat were swelling and achy, pain in jaw to ear, aching and pain in throat area, chills, tongue was numb, could not feel her swallow reflex, blood pressure was elevated to 185/ unknown and pulse was 131 bpm was resolved on 17 Mar 2021. The outcome of shortness of breath and tiredness was unknown. Action taken with mRNA-1273 in response to the events was unknown.; Sender's Comments: This case concerns a 62 Y/O F with serious unexpected pharyngeal swelling and NS unexpected oropharyngeal pain, jaw pain, hypoaesthesia oral, hyporeflexia, blood pressure increased, heart rate increased, dyspnea, and expected lymphadenopathy, lymph node pain, chills, fatigue. Event onset day 1 after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.
62 2021-04-02 fainting Awoke the next day, drank water, immediate lightheadedness led to syncope (likely vasovagal) and eme... Read more
Awoke the next day, drank water, immediate lightheadedness led to syncope (likely vasovagal) and emesis, diaphoresis, followed by several hours of chills. Local erythema, edema and pruritus distal to injection site appeared several days later (also following first injection on right arm) lasting about one week. Treatment: bed rest, benadryl, hydrocotisone
62 2021-04-03 fainting Vasovagal Syncope. Called 911, transported by ambulance to Hospital emergency room.
62 2021-04-04 blood pressure increased, blood pressure decreased 45 minutes post vaccine, returned with complaint of Headache, fatigue. BP 199/100. Gave Acetamino... Read more
45 minutes post vaccine, returned with complaint of Headache, fatigue. BP 199/100. Gave Acetaminophen 1gm. She was confused, on 3d asking about additional meds when bp high, she remembered she has Clonidine 0.1mg, had her take. BP dropped to 179/90, 20 minutes later then 159/90, and went home with husband.
62 2021-04-04 heart flutter, heart rate increased fever today of 99.6 F; Heart feels a little fluttery; heart rate increased; This spontaneous case wa... Read more
fever today of 99.6 F; Heart feels a little fluttery; heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart feels a little fluttery) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history.). On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced CARDIAC FLUTTER (Heart feels a little fluttery) (seriousness criterion medically significant) and HEART RATE INCREASED (heart rate increased). On 10-Mar-2021, the patient experienced PYREXIA (fever today of 99.6 F). At the time of the report, CARDIAC FLUTTER (Heart feels a little fluttery), HEART RATE INCREASED (heart rate increased) and PYREXIA (fever today of 99.6 F) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Electrocardiogram: normal (normal) normal. On 08-Mar-2021, Heart rate: 113 (Inconclusive) heart beats per minute. On 09-Mar-2021, Electrocardiogram: normal (normal) Normal. On 09-Mar-2021, Heart rate: 80 low 90s (Inconclusive) mid to high 80 low 90s beats per minute. On 10-Mar-2021, Body temperature: 99.6 (Inconclusive) 99.6 F. On 10-Mar-2021, Heart rate: 103-104 (Inconclusive) heart beats per minute. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case concerns a 62 Y/O F with a serious unexpected event of cardiac flutter and nonserious unexpected heart rate increased and expected pyrexia. Event onset the same day as first dose mRNA-1273. Events not resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 62 Y/O F with a serious unexpected event of cardiac flutter and nonserious unexpected heart rate increased and expected pyrexia. Event onset the same day as first dose mRNA-1273. Events not resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
62 2021-04-05 fast heart rate Right after immunization patient alert APN monitoring are "Tickle" in her throat and "taste of metal... Read more
Right after immunization patient alert APN monitoring are "Tickle" in her throat and "taste of metal". Then patient started experiencing tachycardia, shortness of breath , and continuously clearing her throat. 02:03pm- BP 130/100, pulse of 96, O2 88%. 2:04 pm--patient experiencing "hot potato voice" and sensation of back of tongue. EPI pen was administered at 2:05 pm. 911 called. 2:08 pm- Benadryl 50 mg IM given. 2:09pm- patient reported some improvement, feeling like she could breathe easier. BP 140/110, pulse 85, O2 93%. 2:11pm- patient transferred to ER via EMS. Later EMS reported had give patient a 2nd dose of EPI due to SOB and wheezing.
62 2021-04-06 cerebrovascular accident Stroke symptoms, double vision, numbness of lips, tongue , mouth and gums. General weekness, sha... Read more
Stroke symptoms, double vision, numbness of lips, tongue , mouth and gums. General weekness, shaking and confusion. Symptoms began receding after 20 minutes. As EMS arived
62 2021-04-06 fainting Witnessed syncopal episode that occurred approximately 5-10 mins s/p Moderna vaccine @ 12:05 pm. LOC... Read more
Witnessed syncopal episode that occurred approximately 5-10 mins s/p Moderna vaccine @ 12:05 pm. LOC lasted approx 30 seconds, pt regained full consciousness without painful stimuli. Pt was placed on cardiac monitor, and in trendelenburg position and vital signs obtained,BP 102/60, (see below). Pt initially reported improvement of symptoms however would experience worsening of symptoms nausea/vomiting, shakiness, and lightheadeness with any mild movement even after 30 mins observed. Pt had two episodes of vomiting total. Since Symptoms of lightheadedness, shakiness nausea worsen with very minimal movement pt states unable to even get out of medical bed. Plan was discussed with patient and patients husband for further evaluation in ER due to persistent symptoms and inability to ambulate on her own without experiencing worsening symptoms. . Therefore EMS was called for transport @ 12:57pm. Pt alert and oriented x 4 , VSS throughout entire observation. Denies CP/SOB/ lip swelling. Outcome of the adverse event (if paramedic please list hospital taken to): EMS called at 12:57pm for transport to ER. EMS arrived on seen at 13: 32pm Pt transported to hospital @ 13:40.
62 2021-04-07 hypotension The day after my second dose of Moderna COVID-19 vaccine, I had sudden onset tinnitus in both ears. ... Read more
The day after my second dose of Moderna COVID-19 vaccine, I had sudden onset tinnitus in both ears. It persists one week later. Never louder, never softer. Always there. No OTC medicine helps. The noise level is moderate (6 out of 10). I also have stuffy sinuses since the vaccination, but relieving sinus pressure using cold medicine does not stop the tinnitus. My blood pressure is now measuring "low hypertension," whereas before it was reliably normal. The soonest an ENT doctor can see me is in 3 weeks. I'm very concerned about possible hearing loss, but at this time, I would guess any hearing loss is mild.
62 2021-04-07 fainting, hypotension Low blood pressure, fainted once while sitting on stool. Patient has similar response when actually ... Read more
Low blood pressure, fainted once while sitting on stool. Patient has similar response when actually having COVID back in October. Possible interaction with blood pressure medicine
62 2021-04-08 palpitations, blood pressure increased, heart rate increased Pt is here today for COVID-19 immunization per federal guidelines/written order. See immunization ac... Read more
Pt is here today for COVID-19 immunization per federal guidelines/written order. See immunization activity for details. Pt was observed post-immunization for a minimum of 15 minutes with evidence of dizziness and nausea, heart palpitations. Anaphylaxis Management Standing Order protocol initiated. Physician/APP notified of patient condition. Additional orders received: none per Dr. COVID-19 (MRNA) VACCINE Allergen added to patient's Allergies. VAERS reporting completed as appropriate. 1640: At end of 15 minute observation, patient complained of sudden onset dizziness, flushing, palpitations and nausea. Immediately brought to exam room and patient began to dry heave (no actual emesis). Cool cloth applied to neck. VITALS: BP 153/81, Pulse "166" via dynamap, but manual recheck was 84. Patient stated symptoms starting to resolve. 1645: Dr. came up from office to evaluate patient. Manual pulse check 80. No shortness of breath or throat tightening. No chest tightness, no rash, no itching. Patient states symptoms much improved. Per Dr. , no additional orders, but observe for 30 additional minutes. 1655: VITALS: BP 161/77, Pulse 67 via dynamap. Patient states she feels much better. Discussed precautions prior to next vaccine (eating and drinking) and consideration of taking oral Benadryl prior to next vaccine (using caution if driving). Also advised she can take a dose of oral Benadryl this evening (has history of bee sting allergy and carries Epi Pens). Verbalized understanding. Patient going home from clinic and accompanied by mom. 1705: Patient states she feels "100% better," and would like to leave. Has been 25 minutes since reaction started. Patient discharged ambulatory. VAERS submitted. COVID-19 post-vaccination Patient Instructions added to After Visit Summary for patient to review in her MyChart account.
62 2021-04-08 palpitations pt developed symptoms of: weakness (to the point of difficulty walking), pounding headache with vis... Read more
pt developed symptoms of: weakness (to the point of difficulty walking), pounding headache with vision changes, shortness of breath with exersion, upper abdominal pain, nausea, vomiting, rash on her legs, back and arms, heart pounding
62 2021-04-08 fast heart rate Patient reports feeling lightheaded, felt her heart was racing. EMS assessed patient, BP:172/104, pu... Read more
Patient reports feeling lightheaded, felt her heart was racing. EMS assessed patient, BP:172/104, pulse 64 (patient did not take her BP meds in the morning). Patient reports feeling better, symptoms improved. Cleared by EMS
62 2021-04-08 blood clot Patient reported to the pharmacy that she was admitted to the hospital for blood clots shortly after... Read more
Patient reported to the pharmacy that she was admitted to the hospital for blood clots shortly after receiving the vaccination and was there for at least 10 days
62 2021-04-09 chest pain On April 6th I awoke with fever, aches, weakness and a headache. The headache persisted all day. ... Read more
On April 6th I awoke with fever, aches, weakness and a headache. The headache persisted all day. On April 7th beginning at 6:20 pm had chest pain radiating under my arms which prompted me to go to the ER. At the ER I had elevated cardiac enzymes which prompted admission to the hospital.
62 2021-04-09 excessive bleeding Bled down her leg; Hematoma on lower leg; Creepy; Rash on legs, hands, wrists, fingers; This spontan... Read more
Bled down her leg; Hematoma on lower leg; Creepy; Rash on legs, hands, wrists, fingers; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers). At the time of the report, HAEMORRHAGE (Bled down her leg), HAEMATOMA (Hematoma on lower leg), FEELING ABNORMAL (Creepy) and RASH (Rash on legs, hands, wrists, fingers) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-059458 (Patient Link).; Sender's Comments: This case concerns a 62-year-old female with a serious unexpected event of hemorrhage, and nonserious unexpected hematoma, feeling abnormal and expected rash. Event onset with unknown latency after first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
62 2021-04-10 deep vein blood clot, pulmonary embolism, blood clot, cerebrovascular accident Blood Clots, Stroke
62 2021-04-11 loss of consciousness Fever aches chills started after 12 hours, 24 hours after dizziness, weakness fatigue. Passed out at... Read more
Fever aches chills started after 12 hours, 24 hours after dizziness, weakness fatigue. Passed out at home after the 24 hour mark. After coming "to" was vomiting. Perhaps was a seizure. The paramedics were called and I was evaluated and all was ok- O2 was fine, sugar 138, BP 110/60. I was to drink pedialyte, rest .
62 2021-04-11 fainting Started out the day with a fever of around 100.8, had body aches, chills then that night I started h... Read more
Started out the day with a fever of around 100.8, had body aches, chills then that night I started having bad stomach cramps and diahreah and I fainted. Had to call 911 and ended up with an overnight stay in the hospital.
62 2021-04-12 heart rate increased, blood pressure increased She got the vaccine and her pulse was high, her BP went up to 164/98, pulse was over 100 and her thr... Read more
She got the vaccine and her pulse was high, her BP went up to 164/98, pulse was over 100 and her throat was tight, numb feeling in her throat. She was jittery and did not know why it was so jittery. They told her to FU with her PCP. She also had a low grade temp of 99.3. They told her to go to the UC which was downstairs and they started her on Benadryl and Pepcid. They sent her home and told her to get Pepcid and Benadryl to take at home and take it for the rest of the weekend. Her arm was sore, which they felt as normal. She then continued to get better and after 4 days the symptoms were gone.
62 2021-04-12 heart rate irregular, atrial fibrillation, fluid around the heart Patient received her second dose of Covid vaccine on 04/08/2021 around 2 PM. She reported around 2 A... Read more
Patient received her second dose of Covid vaccine on 04/08/2021 around 2 PM. She reported around 2 AM Friday 04/09/2021 she woke up feeling lightheaded as if she was going to pass out. She is an RN and felt that her pulse was irregular. She proceeded to the emergency department where she was treated. She reports her EKG showed a-fib with RVR and an xray showed new onset mild "CHF" or fluid around her heart. They did not cardio-vert her as she reports she was "stable". She was sent home on eliquis and metoprolol. Over the weekend 04/09-04/11/2021 she reported irregular pulse anywhere from 45-135 BPM. She did report a 5 pound weight gain during that time. On Monday 04/12/2021 she followed up with her primary care physician, Dr. of Health. She reports on her way to the doctor she felt as if "something changed" and her heart rate was no longer irregular. She did have another EKG done in office and she reports that EKG showed normal sinus rhythm. She is seeing a cardiologist on Wednesday 04/14/2021. She reports after her first vaccine on 03/11/2021 she had mild side effects of fatigue, fever, and chills. She states she does not have any cardiac issues but does report "a few years ago" she had drank a energy drink and had a-fib from that.
62 2021-04-12 palpitations, chest discomfort Heart palpitations, intermittent for about 5 minutes, chest/lung pressure for about 3 hours, 24hours... Read more
Heart palpitations, intermittent for about 5 minutes, chest/lung pressure for about 3 hours, 24hours of nausea, temp 101.5, Throbbing headache, fatigue and sore neck /shoulder & swollen glands in neck. Soreness in ALL joints for 1 Week.
62 2021-04-12 fainting, hypertension, chest pain Female smoker w/ obesity, insomnia, HL, anxiety, bronchitis, diverticulitis, GERD, OA, COPD, MIx2 an... Read more
Female smoker w/ obesity, insomnia, HL, anxiety, bronchitis, diverticulitis, GERD, OA, COPD, MIx2 and HTN was given her 1st dose of Moderna Covid19 vaccine (lot # 046B21A) at 1310 4/13/21. Patient had hot flash and was fanning herself within 5 minutes of 15 minute observation time. After 15-20 more minutes, patient developed mild chest pain, nausea, diaphoresis and shortness of breath. Patient reported feeling light headed. Patient was moved to the recliner and her legs elevated. Patient found to be hypertensive. Initial BP 162/106. At 1346, BP 180/84. At 1352, NIBP 186/93, pulse 80's and regular. Per NP, bilateral diminished breath sound with wheezes. SaO2 on room air 97-99%, with the labored breathing and chest pain. Placed on oxygen 2L pm via NC. EMS notified for transport to ED. Chest pain increased 8/10. Patient refused nitroglycerin but accepted ondansetron 4mg po for nausea. Also given 324mg aspirin. In ED, EKG and Chest XR obtained. Both were normal. BP still elevated at 1442 171/83. Patient stable.
62 2021-04-12 blood clot Blood clot; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence ... Read more
Blood clot; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant) and COVID-19 (COVID-19). At the time of the report, THROMBOSIS (Blood clot) and COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) postive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Products known to have been used by the patient, within two weeks prior to the event, included blood thinner medication. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
62 2021-04-13 cerebrovascular accident Stroke
62 2021-04-13 chest discomfort Fever, chills, shaking started at 3 am and persisted even with tylenol until the next evening. Fever... Read more
Fever, chills, shaking started at 3 am and persisted even with tylenol until the next evening. Fever ranged from 99.5 to 102.5. Headache-severe and nausea lasted until the following day, muscle aches and weakness severe until two days later. It?s now 4 days and still have significant weakness and persistent cough and chest tightness and discomfort.
62 2021-04-13 hypertension Hypersensitivity high blood pressure, blood sugar, fatigue, lightheaded, bacterial infection
62 2021-04-13 heart attack Per the patient's husband, on 03/26/2021, the day after vaccination, the decedent complained of naus... Read more
Per the patient's husband, on 03/26/2021, the day after vaccination, the decedent complained of nausea with vomiting, and had difficulty driving. On 03/27/2021, her nausea continued and she complained of shortness of breath while walking. On 03/28/2021, she was short of breath before vomiting a small amount. She then became unresponsive. Death was pronounced a short time later. Per her treating physician who signed the death certificate, the cause of death is felt to be probable myocardial infarction due to electrolyte abnormalities due to complications of her diabetes mellitus.
62 2021-04-13 inflammation of the pericardium Patient says that 2 days post vaccination that she was having difficulty breathing. They admitted h... Read more
Patient says that 2 days post vaccination that she was having difficulty breathing. They admitted her in the hospital and she said she had inflammation around her heart.
62 2021-04-13 transient ischaemic attack TIA 3/1/21.
62 2021-04-14 atrial fibrillation Patient had anxiety on arrival to the Covid vaccine clinic. Went into rapid atrial fibrillation on... Read more
Patient had anxiety on arrival to the Covid vaccine clinic. Went into rapid atrial fibrillation on arrival due to anxiety. This occurred prior to receiving the vaccine. Patient recovered on her own and later received the vaccine. She then went back into rapid Afib and was transferred to the Emergency Department. Patient has a long history of A fib. Does not appear to be vaccine related.
62 2021-04-14 heart rate increased Headache, Body pain all over, increased heart rate, vomiting, chills, lethargy. Experienced for 1 m... Read more
Headache, Body pain all over, increased heart rate, vomiting, chills, lethargy. Experienced for 1 month and still only feels 90%
62 2021-04-14 hypertension, haemoglobin decreased, chest pain, cardio-respiratory arrest, platelet count decreased, increased heart rate, anaemia Received her first COVID vaccine on Thursday, March 18. On 3/23/21 she started to have new onset o... Read more
Received her first COVID vaccine on Thursday, March 18. On 3/23/21 she started to have new onset of generalized muscles aches and weakness. She started feeling some pain in her back, which then spread to arms and legs. She is now beginning to feel weakness in her core and extremities. Having difficulty lifting arms above head. She is still able to walk without difficulty but legs do feel weak. Increase in SOB as well. Myalgias and chest pain resolved within a week, however she continued to feel weak, tired, and had DOE. She developed "brain fog" and talked to her boss about taking short-term disability as it had been hard to work. No appetite. On 4/1/21, she presented to the ED with 2 weeks of worsening generalized weakness, SOB, lightheadedness, dizziness and found to have acute anemia. Was admitted for further workup. Hgb at admission was 5.4. This admission diagnosed her with a new warm autoantibody hemolytic anemia. This is new since the COVID vaccine was administered. Upon admission there was no thrombocytopenia, so there was low suspicion for microangiopathic hemolytic anemia, TTP/HUS, or DIC. Peripheral blood smear at that time suggested a leukoerythroblastic blood picture (could be Bone Marrow recovery post chemo) but with marked normocytic, normochromic anemia, and with increased circulating erythroid precursors and increased red blood cell regeneration; spherocytes and fragments are present supporting hemolysis. DAT positive (both IgG and C3) along with other hemolysis lab including elevated LDH, Bilirubin, haptoglobin 3, and PBS c/w hemolysis; no evidence of MAHA. So warm autoantibody hemolytic anemia is the most likely explanation. She had negative cold agglutinin antibodies <1:32 on 4/9. Started on methylprednisolone on 4/2/21, but Hgb continued to steadily decline despite treatment. Continued on methylprednisolone 87.5mg daily. Rituxan 375mg/m2 was started on 4/6/21 with plans for weekly infusions for a total of 4 weeks. there was concern for a GI bleed on 4/10-4/11 due to bright red fluid appearing like blood in the toilet after a stool. This led to her receiving roughly 5 units of pRBCs. After these 5 units she started urinating red urine and we became highly concerned for hyperhemolysis. She did not have any further stools so we did not think a GI bleed was likely. She was given 1 dose of Eculizumab (Soliris) (4/12). This treatment is for complement mediated intravascular hyperhemolysis. Unfortunately it did not appear to help her. On 4/14, we were thinking TTP could be contributory with numerous schistocytes on peripheral smear. Her T bili was up to 7.8, and her hemoglobin plasma was trending up, in the 380 -- > 610 and in the 800s today. Cr was worsening. Platelet count was dropping. With her worsening condition and concern for both hyperhemolysis and possible TTP, we decided to start her plasma exchange followed by her second dose of Rituximab. Unfortunately she became disoriented/confused following line placement and while receiving plasmaphoresis. CT head returned without acute findings. She then had an allergic reaction with a rash during PLEX which was stopped (4L completed with a goal of 5L). Improved with benadryl. She was then administered rituximab. Then she developed worsening sinus tachycardia and HTN. Her respiratory status deteriorated and she eventually required high-flow oxygen to maintain saturations > 90%. CXR showed bilateral opacities, not drastically changed from previous films. Rituximab was stopped halfway through its infusion in case this was an adverse effect to the drug. She was given 20 mg IV Lasix per the nighttime sign-out. She was initially given ceftriaxone and azithromycin IV to cover CAP but later ABx were broadened to vanc and Zosyn with rising lactate of unknown source. Ultimately she had acute respiratory failure with hypoxia and need BiPAP. She was eventually intubated and a code blue was called. She unfortunately died shortly after intubation.
62 2021-04-14 hypertension Patient is a 62 year old female who has completed a 15-minute observation period with the following ... Read more
Patient is a 62 year old female who has completed a 15-minute observation period with the following signs and symptoms of an adverse reaction: other - itching of the shoulders. Denies use of new clothes, chemicals, lotions. The symptoms started 15 minutes post vaccination. Endorsed that she feels like having the same reaction when drinking wine and takes benadryl for the itching. Hypertensive otherwise VSS. Physical exam unremarkable. Given Cetirizine and pruritus resolved
62 2021-04-15 loss of consciousness sweating; dizziness; weakness; passed out; arm soreness; headaches; This spontaneous case was report... Read more
sweating; dizziness; weakness; passed out; arm soreness; headaches; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history). Concomitant products included LISINOPRIL for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and HEADACHE (headaches). On 12-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), HYPERHIDROSIS (sweating), DIZZINESS (dizziness) and ASTHENIA (weakness). On 12-Mar-2021, LOSS OF CONSCIOUSNESS (passed out), HYPERHIDROSIS (sweating) and DIZZINESS (dizziness) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness), ASTHENIA (weakness) and HEADACHE (headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
62 2021-04-15 fast heart rate About 12 hours after first dose given on 3/3/2021 I developed tacchycardia. Called doc, put me on l... Read more
About 12 hours after first dose given on 3/3/2021 I developed tacchycardia. Called doc, put me on low dose beta blocker. Stopped the following day. --- Following are reactions from 2nd dose given on 3/31/2021: (1) 2 days after receiving 2nd shot I woke up with extreme pain and swelling in all my joints (no issues/flares) before the vaccine! Extremely cold - NO FEVER - Later that morning I developed the Covid Vaccine Rash on my arm about 2 inches below injection site. Arm was not swollen but it was tender and a bit warm. Took benadryl, went away in two days. For the following 7 - 10 days, I had EXTREME JOINT PAIN, FATIGUE AND MALAISE. Went to my family doc - no fever, no cough, no headache. Doc felt the immune response from the Vaccine may have thrown me into an RA/Fibro Flare. Prescribed mobic and muscle relaxer for joint pain. On Day 10 after the vaccine, I developed a HUGE STYE in my left eye., being treated with antibiotic eye ointment. I am now 16 days out from the 2nd Moderna dose and am finally starting to feel human again. I hope I am on the Upswing now. Fatigue is diminishing along with extreme joint pain.
62 2021-04-15 transient ischaemic attack, cerebrovascular accident Date and time adverse event started: 26th March, Monday evening, had stroke-like symptoms. Went to h... Read more
Date and time adverse event started: 26th March, Monday evening, had stroke-like symptoms. Went to hospital on the 27th, dx of a stroke. Patient has a dx of a stroke, went to hospital, since d/c'd to home with residual. patients reports no changes, was diagnosed with a TIA and pending follow ups with heart doctor & neurologist. Q99- asked if she should take the 2nd dose. recommended she follow up with her PCP and neurologist to discuss risks and benefits of the 2nd dose, patient verbalized understanding.
62 2021-04-16 body temperature decreased Chills, Teeth chattering, muscle aches, joint aches and throbbing pain, severe pain in the back of n... Read more
Chills, Teeth chattering, muscle aches, joint aches and throbbing pain, severe pain in the back of neck, fatigue, 96.5 fever for 6 hours, then fever went to 100.1 for 5 hours
62 2021-04-16 loss of consciousness, blood clot, cerebral haemorrhage My wife started to fall and pass out had no strength to get up this happened two to three times cinc... Read more
My wife started to fall and pass out had no strength to get up this happened two to three times cinch she got the shot the last time she past out in the shower and i rushed her to hospital were she pasted away from blood clots to the right side of the neck and stated bleed on the brain
62 2021-04-16 pulmonary embolism, chest pain pulmonary embolism body aches, HA, chest pain, shortness of breath
62 2021-04-18 hypertension Developed high blood pressure 168/100 (MAP 101)around 40 mins after vaccination which lasted more th... Read more
Developed high blood pressure 168/100 (MAP 101)around 40 mins after vaccination which lasted more than an hour. I had pain from my left shoulder , left neck up to the base of my left head like throbbing pain. My left ear felt numb and warm since i was slightly reddish up to my arms. I didn't have to take any antihistamine since it subsided after half an hour.
62 2021-04-18 fainting Patient in observation. Patient experienced syncope for approximately 10 seconds. Patient awakens. P... Read more
Patient in observation. Patient experienced syncope for approximately 10 seconds. Patient awakens. Patient vital signs BP-179/79 HR-76 T-98.6. When patient awaken, AOx3 and she began drinking a bottle of water. Patient monitored. Patient husband and daughter in car. Patient monitored. Vital signs retaken BP-138/78 HR-64 R-16. Patient verbalizes feeling better and anxiety has decreased. Patient and family educated on worsen symptoms and when to seek medical attention.
62 2021-04-19 loss of consciousness Extreme fatigue to the point of passing out at the dinner table. I had to carry her to bed. Thankfu... Read more
Extreme fatigue to the point of passing out at the dinner table. I had to carry her to bed. Thankfully she recovered almost entirely by the next morning. It was a sudden onset and her first injection (lot #036A21A administered on March 19, 2021) did not cause this reaction or anything near it.
62 2021-04-20 blood glucose increased, cerebral haemorrhage, bleeding on surface of brain She was transferred from one ER to another for intraparenchymal bleed and subarachnoid hemorrhage wi... Read more
She was transferred from one ER to another for intraparenchymal bleed and subarachnoid hemorrhage with midline shift. On the week of April 11th she was seen by her periodontist of a bone graft in preparation for a tooth implant. She took minimal ibuprofen and norco after this procedure. However, she also began to feel very nauseated which led to anorexia and worsening malaise. This prompted the pt to present to ER on 4/16 evening, where was given Phenergan, and discharged to home. Symptoms worsened and she re-presented to ED where she was admitted and diagnosed with UTI and colitis. She was started on ciprofloxacin. She denied having had any dysuria or diarrhea. Patient's son says that at 0130 on 4/19 his mother was using both sides of her extremities equally. She had been complaining of headache and leg pain, but by 0130 on 4/19 family did not notice any other obvious changes in patient's movements or behavior. However, at 0730 on 4/19 nurses noticed that patient was unable to move her L arm or leg. She had a CT scan done, which revealed multiple intraparenchymal hemorrhages bilaterally as well as subarachnoid hemorrhage with midline shift. The transferring physician told me that patient had not been on any anticoagulation. Patient and her family deny any history of falls or trauma, denied family history of coagulopathies, and use of blood thinners (including aspirin). No records, labs, or inpatient med list was sent with patient upon transfer. Family says that patient had her first Moderna COVID19 vaccine 3 weeks ago and was due for her second vaccine on 4/23. Labs on admit here are significant for leukocytosis with WBC of 21.9, Hgb of 12.1, platelets of 306, sodium of 140, potassium of 3.1, Bicarb of 22, creatinine of 0.7, glucose of 126, magnesium of 1.8, INR of 1.2. Patient is normotensive, afebrile, and satting well on room air. Angiogram showed multiple cortical vein thromboses. Will send hypercoagulable work up, HIT antibody given COVID vaccine 3 weeks ago (Moderna).
62 2021-04-20 chest pain, loss of consciousness took 3 steps and just blacked out and passed out; coughing; black eye; didn't remember losing her co... Read more
took 3 steps and just blacked out and passed out; coughing; black eye; didn't remember losing her consciousness; When she sneezes or cough her chest hurts; can't turn over while sleeping at night; she has not gotton back to normal; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (took 3 steps and just blacked out and passed out) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history.). On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (took 3 steps and just blacked out and passed out) (seriousness criterion medically significant), COUGH (coughing), EYE CONTUSION (black eye), MEMORY IMPAIRMENT (didn't remember losing her consciousness), CHEST PAIN (When she sneezes or cough her chest hurts), MOVEMENT DISORDER (can't turn over while sleeping at night) and FEELING ABNORMAL (she has not gotton back to normal). At the time of the report, LOSS OF CONSCIOUSNESS (took 3 steps and just blacked out and passed out), COUGH (coughing), EYE CONTUSION (black eye), MEMORY IMPAIRMENT (didn't remember losing her consciousness), CHEST PAIN (When she sneezes or cough her chest hurts), MOVEMENT DISORDER (can't turn over while sleeping at night) and FEELING ABNORMAL (she has not gotten back to normal) had not resolved. Not Provided Treatment information was provided as tylenol. No concomitant information was provided. Patient mentioned she is a vegan no meat, diary, does not take pills. Woke up next morning, she had a black eye, her reading glasses were broken, didn't remember loosing her consciousness. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-076632 (Patient Link). Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
62 2021-04-20 hypotension whole body chills, elevated (99.3 to 100) body temperature, very tired, very low blood pressure (98/... Read more
whole body chills, elevated (99.3 to 100) body temperature, very tired, very low blood pressure (98/44)
62 2021-04-20 lightheadedness Dizzy; Fever 101 degrees Fahrenheit; Nausea; Body aches; Seizure; Symptoms like the flu; Felt like s... Read more
Dizzy; Fever 101 degrees Fahrenheit; Nausea; Body aches; Seizure; Symptoms like the flu; Felt like she was going to faint; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history provided.). On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Symptoms like the flu), DIZZINESS (Dizzy), PYREXIA (Fever 101 degrees Fahrenheit), NAUSEA (Nausea) and MYALGIA (Body aches). On an unknown date, the patient experienced PRESYNCOPE (Felt like she was going to faint). At the time of the report, SEIZURE (Seizure), INFLUENZA LIKE ILLNESS (Symptoms like the flu), PRESYNCOPE (Felt like she was going to faint), DIZZINESS (Dizzy), PYREXIA (Fever 101 degrees Fahrenheit), NAUSEA (Nausea) and MYALGIA (Body aches) outcome was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-054366 (E2B Linked Report). This case was linked to MOD-2021-077998, MOD-2021-077998 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-054366:
62 2021-04-20 transient ischaemic attack 18 hours after my 2nd moderna vaccine, I experienced slurred speech. When I arrived by car at my d... Read more
18 hours after my 2nd moderna vaccine, I experienced slurred speech. When I arrived by car at my destination, I checked into a motel, looked into the mirror and noticed my left side of my face was drooping. I knew this was sign of stroke. I called 911 right away. I was taken to hospital. They did a CBC the night I arrived and the next day as well. They did 2 cat scans with and without contrast. Dr. in the ER determined that I had suffered a Transient Ischemic Attack which was brought on in less than 24hours of the 2nd Modern vaccine shot, and that the TIA was from the vaccine. THe cat scans did not reveal any blood clots at the time of the scans. Dr. concluded that they had broken up quickly and that was why he diagnosed me with TIA.
62 2021-04-20 cardiac arrhythmia, fluid around the heart, palpitations Very ill evening post 2nd dose on 1/25/21 with extreme nausea, fatigue. Some headache, sore arm. Mid... Read more
Very ill evening post 2nd dose on 1/25/21 with extreme nausea, fatigue. Some headache, sore arm. Mid Feb began to experience heart palpitations, PAC and PVCs. Went to see Cardiologist and with stress echo dx with pulmonary hypertension. Getting right heart cath today
62 2021-04-21 chest pain On March 22, 2021, she noted a dry cough, chest and abdominal pain. Her PCP started her on omeprazol... Read more
On March 22, 2021, she noted a dry cough, chest and abdominal pain. Her PCP started her on omeprazole and an albuterol inhaler with improvement in the cough, but her abdominal pain worsened. She was hospitalized at Hospital from April 5-8, 2021 (4 days) with epigastric and right upper quadrant abdominal pain. A CAT scan angiogram of the abdomen and pelvis showed occlusive thrombus involving the main, left and right portal as well as the adjacent superior mesenteric and splenic veins. Her platelet count was normal. She was treated with IV unfractionated heparin transitioned to apixaban. I saw her as an outpatient today. She remains on apixaban and still has abdominal pain after eating.
62 2021-04-21 hypertension, chest pain Fever, nausea, diarrhea, migraines, sore throat, knee swelling, scaling of skin, chest pain, severe ... Read more
Fever, nausea, diarrhea, migraines, sore throat, knee swelling, scaling of skin, chest pain, severe hypertension
62 2021-04-21 palpitations 1 hour after vaccine ---EXTREME HEART PALPATATIONS--FELT I WOULD PASS OUT WHEN I STOOD UP---LASTER A... Read more
1 hour after vaccine ---EXTREME HEART PALPATATIONS--FELT I WOULD PASS OUT WHEN I STOOD UP---LASTER APPROX 20 MIN.----THEN 1 HOUR LATER MORE EXTREME HEART PALPATATIONS AGAIN.
62 2021-04-21 fainting headache got a little worse, severely dizzy, then I fainted. I laid on the ground for about 10 minu... Read more
headache got a little worse, severely dizzy, then I fainted. I laid on the ground for about 10 minutes, then I was okay.
62 2021-04-22 cardiac arrest On 3/15 had a cardia arrest and is currently comatose
62 2021-04-22 chest discomfort, hypertension Patient stated she felt flushed and her skin was warm and moist. Patient reported having pressure in... Read more
Patient stated she felt flushed and her skin was warm and moist. Patient reported having pressure in her chest.
62 2021-04-22 loss of consciousness After eight hours after receiving the second dose, the normal sx of the COVID vaccine occurred (musc... Read more
After eight hours after receiving the second dose, the normal sx of the COVID vaccine occurred (muscle aches, fatigue). On the morning of 04/23/21, the patient completely lost consciousness and was not breathing. The caregiver (son) performed CPR and the patient regained consciousness. Paramedics were called and performed and EKG, blood glucose, and BP/HR - all were normal. Pt is resting but still in pain.
62 2021-04-22 pulmonary embolism found several blood clots in her lungs; it (difficulty breathing) became worse; difficulty breathing... Read more
found several blood clots in her lungs; it (difficulty breathing) became worse; difficulty breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (found several blood clots in her lungs) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (difficulty breathing). On 05-Apr-2021, the patient experienced CONDITION AGGRAVATED (it (difficulty breathing) became worse). On 07-Apr-2021, the patient experienced PULMONARY EMBOLISM (found several blood clots in her lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-Apr-2021 to 11-Apr-2021 due to PULMONARY EMBOLISM. On 15-Apr-2021, DYSPNOEA (difficulty breathing) and CONDITION AGGRAVATED (it (difficulty breathing) became worse) had resolved. At the time of the report, PULMONARY EMBOLISM (found several blood clots in her lungs) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, COVID-19: negative (Negative) Test results came back negative on 06Apr2021. On 07-Apr-2021, X-ray: abnormal (abnormal) Blood clots in lungs. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. After x-ray at urgent care on 07-Apr-2021 showed several blood clots in lungs, the patient was taken to the ER (emergency room) and was subsequently admitted to the hospital. Treatment information was not provided. On 12-Apr-2021 the patient went to their PCP (primary care physician) who stated that the clots most likely were not due to the vaccination and that the 2nd dose was safe for her to receive. At the time of this report on 15-Apr-2021, the patient reported feeling fine. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events 1-3 days after the vaccination, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events 1-3 days after the vaccination, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. Further information has been requested.
62 2021-04-22 low platelet count, platelet count decreased Thrombocytopenia with platelet count of 3,000 Acute kidney injury
62 2021-04-22 transient ischaemic attack Nausea/vomiting, fatigue. Hospitalized the next day. Doctors say she may have had a mini stroke
62 2021-04-23 palpitations Diagnosed with pulmonary hypertension; After two half weeks she started having palpitation; This spo... Read more
Diagnosed with pulmonary hypertension; After two half weeks she started having palpitation; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PULMONARY HYPERTENSION (Diagnosed with pulmonary hypertension) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PULMONARY HYPERTENSION (Diagnosed with pulmonary hypertension) (seriousness criterion medically significant) and PALPITATIONS (After two half weeks she started having palpitation). At the time of the report, PULMONARY HYPERTENSION (Diagnosed with pulmonary hypertension) had not resolved and PALPITATIONS (After two half weeks she started having palpitation) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was unknown. Treatment information was not provided. Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
62 2021-04-23 lightheadedness Abdominal Pain Severe, Sweating Heavily, Shooting Pains Up Back, Severe Diarrhea (Watery,Shooting o... Read more
Abdominal Pain Severe, Sweating Heavily, Shooting Pains Up Back, Severe Diarrhea (Watery,Shooting out of me), Severe Nasea,, Weakness, Fatigue, Could not stand up, Dizzy,, Spins, Close to Fainting, Never Vomitted, Called Ambulance Went to Emergency, Let me go After about 6 Hours .Next 5 days after incident, I was still Extremely Weak, Fatigued, Slept A lot, Ate Minimal Amount of Very Bland Food, Still had Severe Pain in Stomach, Touch my Stomach and it Really Hurt, Swelling Around Shot Area Was now a Hard Knot Sensititve to Touch.
62 2021-04-24 loss of consciousness Headache, nausea, muscle aches, blackouts
62 2021-04-25 palpitations, hypertension Patient had vaccine and was in the observation area. After 10 minutes stated that her heart was raci... Read more
Patient had vaccine and was in the observation area. After 10 minutes stated that her heart was racing and it was 120-130 beats per min and had a blood pressure of 187/110, pulse ox was 100%. No complaints of headache or dizziness. Rechecked patient after 5 minutes and blood pressure was 190/104, HR 130s. Patient was transported to the Emergency department.
62 2021-04-26 cardiac arrest, blood glucose increased Nausea, vomiting, burning in stomach, high blood sugars- symptoms started the day after the vaccine.... Read more
Nausea, vomiting, burning in stomach, high blood sugars- symptoms started the day after the vaccine. Found obtunded 3 days after vaccine given. 911 called in route to the hospital had a cardiac arrest, resuscitated, arrested again and resuscitated. Upon admission to the hospital diagnosed with diabetic ketoacidosis and died the next day- 4 days after the vaccine was administered
62 2021-04-26 cerebrovascular accident CVA causing right hand weakness starting 1 day after vaccine
62 2021-04-26 heart rate increased Immediate elevated heart rate 155 resting for 4 hours. Dizziness onset 72 hours later with ear ringi... Read more
Immediate elevated heart rate 155 resting for 4 hours. Dizziness onset 72 hours later with ear ringing. Now 7 weeks later and vertigo and tinnitus continued. ENT visit and tests show no known cause.
62 2021-04-26 low blood oxigenation COVID virus test positive; low oxygen; weakness; fever; chills; This spontaneous case was reported b... Read more
COVID virus test positive; low oxygen; weakness; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (low oxygen) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced HYPOXIA (low oxygen) (seriousness criterion medically significant), ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills). At the time of the report, HYPOXIA (low oxygen), ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Coronavirus test: positive (Positive) Tested positive for COVID-19 and. On 15-Apr-2021, Coronavirus test negative (Negative) Tested negative for COVID-19. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. The patient, immediately after the vaccination experienced low oxygen, fever, chills, and weakness and these symptoms lasted for 13 days.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The causality for positive COVID-19 test is unlikely.
62 2021-04-26 loss of consciousness, chest discomfort I received my second dose of the Modern vaccine about 3:15 pm on April 22. That night I went to bed ... Read more
I received my second dose of the Modern vaccine about 3:15 pm on April 22. That night I went to bed experiencing the same symptoms as I had after my first dose of the vaccine: soreness in vaccine site, stiffness in my arm, headache, stiff neck, body aches and feeling lethargic. At about 5:30 am, I was awaken with a strange, unexplainable heaviness in my muscles and chest, my breathing felt shallow and I had a strong urge for a bowel movement. I got up, had a bowel movement (not diarrhea), began to sweat and shake, and then began to have the dry heaves, but did not expel any fluid, not even bile. At this point my husband said he heard strange sounds coming out of the bathroom and came to check on me. He found me passed out and said I was making strange snoring sounds and thought I was having difficulty breathing. The next thing I remember is him calling my name and struggling to gain consciousness. At this point, I was very dizzy and nauseous and lay down on the floor. My legs starting shaking sporadically and my breathing felt shallow. When I felt stable enough, my husband helped me back to bed and I fell asleep immediately and slept for about an hour and half. I was awakened by the same symptoms and proceeded to repeat the previous episode. After I passed out for the second time, my husband insisted that I go to the emergency room. In the emergency room, I underwent bloodwork, an EKG and they began administering IV fluids and 4 mg of Zoran. All test results came back normal. I was discharged and went home. After being released, I did not have any further episodes. The only symptoms I experienced after the episodes were a headache and backache, which were not relieved by Tylenol, lethargic and slept for the better part of the next two days. I did not at any time during these episodes or after or prior to the vaccine experience a fever, sore throat, cough, vomiting or diarrhea. I am not at this time, nor have I for many years been on any medication. In the past, I have been highly sensitive to medications and anesthesia and have experienced adverse reactions, even to some over-the-counter medications.
62 2021-04-27 blood pressure increased Hives/rash appeared and has been getting worse; not itchy, a little sore, mildly swollen, mildly red... Read more
Hives/rash appeared and has been getting worse; not itchy, a little sore, mildly swollen, mildly red. It's Inside the elbow and inside L arm toward the wrist and toward armpit, all along the inner arm, Describes them as red uneven and crusty in appearance adv that this type of rash is not likely related to the shot given placement on the opposite arm but concerned for medical issues (ex I'm concerned for shingles possibly, given placement and description of the rash), would adv FU with a HCP first thing in the morning. Provided phone number for follow up if anything worsens tonight and PCC will check back in the morning 4/27-patient calling back, states her symptoms have improved . caller had mentioned that she was so lethargic for a few days, sx have subsided
62 2021-04-29 fainting Felt hot and sweaty for a few minutes. Walked over to restroom, felt dizzy and fainted for about a m... Read more
Felt hot and sweaty for a few minutes. Walked over to restroom, felt dizzy and fainted for about a minute or so I was told. I called my primary care provider?s office and I was advised to go to ER which I did. ER records list the cause of the syncope as ?vaccine reaction.?
62 2021-04-30 loss of consciousness blacked out; can't remember much about it and don't know how she got on the floor; hard to get up; h... Read more
blacked out; can't remember much about it and don't know how she got on the floor; hard to get up; headache; still tired; stomach is real messed up; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is real messed up), HEADACHE (headache) and FATIGUE (still tired). On 22-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (seriousness criterion medically significant), AMNESIA (can't remember much about it and don't know how she got on the floor) and DYSSTASIA (hard to get up). On 22-Apr-2021, LOSS OF CONSCIOUSNESS (blacked out) and DYSSTASIA (hard to get up) had resolved. At the time of the report, AMNESIA (can't remember much about it and don't know how she got on the floor) outcome was unknown, ABDOMINAL DISCOMFORT (stomach is real messed up) and FATIGUE (still tired) had not resolved and HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not reported. Treatment information was not provided. Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Headache and fatigue are consistent with the product safety profile; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Headache and fatigue are consistent with the product safety profile
62 2021-04-30 inflammation of the heart muscle, chest pain The patient presented with pleuritic chest pain and shortness of breath. Was diagnosed with Acute My... Read more
The patient presented with pleuritic chest pain and shortness of breath. Was diagnosed with Acute Myopericarditis with a Cardiac MRI and Echocardiography. Was started on Colchicine and Ibuprofen. The patient was readmitted within 2 weeks with a large pericardial effusion with early tamponade physiology
62 2021-05-01 hypotension At about 8:00 a.m. on Saturday, April 17, 2021, the morning after my 2nd Moderna COVID19 vaccination... Read more
At about 8:00 a.m. on Saturday, April 17, 2021, the morning after my 2nd Moderna COVID19 vaccination, I woke up with shaking chills, a bad headache, and body aches. By the afternoon of 4/17/21, I had a fever of 100 F, and I was so weak, I could not walk to the bathroom, without feeling like passing out. My husband had to help me with walking to the bathroom. My blood pressure on 4/17/21, became very low, at 4:00 p.m., my husband took my blood pressure, and it was 106/52, my Temp was 100F. I was able to drink water, and electrolyte fluids while I was experiencing all this. My left arm where I had the vaccine was painful, but tolerable. I was also very nauseous, however, I did not throw up. This continued for two days. It was very concerning that I was so weak that I could not make it to the bathroom by myself. I called and spoke with a nurse on call at Medical Group, , about these symptoms. I also spoke with a nurse at Medical Group on Monday, April 18, 2021.
62 2021-05-02 heart rate increased, loss of consciousness Moderna COVID-19 Vaccine EUA Dizziness fell to floor after standing and passed out (stayed in bed re... Read more
Moderna COVID-19 Vaccine EUA Dizziness fell to floor after standing and passed out (stayed in bed remainder of day), normal other symptons: sore throat, headache, fever, chills, fatigue, joint pain, 93 rapid heart beat, ringing in ears
62 2021-05-03 fainting patient experienced sore throat, fatigue, coughing sneezing, runny nose for 2.5 weeks starting 24 ho... Read more
patient experienced sore throat, fatigue, coughing sneezing, runny nose for 2.5 weeks starting 24 hours after receiving immunization, patient experienced syncopal episode 3 weeks after immunization on 04/29/2021, but patient also reported being in the shower at time of incident.
62 2021-05-04 cerebrovascular accident stroke at vision site; partial sight lost in left eye; feeling weak; This spontaneous case was repor... Read more
stroke at vision site; partial sight lost in left eye; feeling weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke at vision site) and BLINDNESS (partial sight lost in left eye) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Implantable cardioverter defibrillator insertion. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke at vision site) (seriousness criteria hospitalization and medically significant), BLINDNESS (partial sight lost in left eye) (seriousness criteria hospitalization, disability and medically significant) and ASTHENIA (feeling weak). The patient was hospitalized from 20-Apr-2021 to 21-Apr-2021 due to BLINDNESS and CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke at vision site), BLINDNESS (partial sight lost in left eye) and ASTHENIA (feeling weak) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Computerised tomogram: (abnormal) Stroke at vision site. On 20-Apr-2021, Magnetic resonance imaging: (abnormal) Stroke at vision site. No concomitant medication were reported. The reporter stated that the patient was taking medicines but doctor changed her medication and she did not want to talk so she did not give names.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
62 2021-05-04 nosebleed Nosebleed lasting about 20 minutes. 4/10- 2 nosebleeds, one AM, one PM, 4/11 2 nosebleeds, one AM, ... Read more
Nosebleed lasting about 20 minutes. 4/10- 2 nosebleeds, one AM, one PM, 4/11 2 nosebleeds, one AM, one PM that lasted nearly 3 hours. 4/16 one nosebleed, in PM, 4/4/20 one nosebleed in AM. Used gauze and pressure. Finally learned afrin can help, so last bleed used it and it stopped relatively quickly. All nosebleeds lasted 20-30 minutes except for the 3 hour one. I've never had a nosebleed in my life prior to this. I did contact the Health Xept., who to,d me to report it. The only side effect I had with first dose on March 3 was a headache that lasted on and off for 3 weeks. I did go 5 weeks in between dose, and save for the nosebleeds, had no other side effects, not even a sore arm.
62 2021-05-04 hypertension, palpitations, fast heart rate pt c/o of weakness in legs and heart palpitations. v/s initiated pt appeared to be tachycardic and h... Read more
pt c/o of weakness in legs and heart palpitations. v/s initiated pt appeared to be tachycardic and hypertensive, monitoring continued , remained hypertensive and tachycardic. pt denied chest pain, blurry vision and headache. No improvement EMS activated. Pt handed off at 18:38 to EMS
62 2021-05-04 hypertension High Blood Pressure 200/110 mmHg; Excruciating Severe Headache (After Second Shot)/Excruciating Pain... Read more
High Blood Pressure 200/110 mmHg; Excruciating Severe Headache (After Second Shot)/Excruciating Pain on the Right Side of Head; Pain in the Right Side of the Neck and Right Shoulder; No Energy,Not myself; Not Myself" (After Second Shot); she is not able to sleep at night from the Pain; Excruciating Pain on the Right Side of Head when CoughExcruciating Pain on the Right Side of Head when Cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High Blood Pressure 200/110 mmHg), HEADACHE (Excruciating Severe Headache (After Second Shot)/Excruciating Pain on the Right Side of Head) and ARTHRALGIA (Pain in the Right Side of the Neck and Right Shoulder) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Colon cancer stage II (last chemo was 6 years ago.). Concomitant products included LOSARTAN, METOPROLOL and AMLODIPINE for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced HYPERTENSION (High Blood Pressure 200/110 mmHg) (seriousness criterion hospitalization), HEADACHE (Excruciating Severe Headache (After Second Shot)/Excruciating Pain on the Right Side of Head) (seriousness criteria hospitalization and medically significant) and ARTHRALGIA (Pain in the Right Side of the Neck and Right Shoulder) (seriousness criterion hospitalization). On 27-Apr-2021, the patient experienced ASTHENIA (No Energy,Not myself), FEELING ABNORMAL (Not Myself" (After Second Shot)), INSOMNIA (she is not able to sleep at night from the Pain) and COUGH (Excruciating Pain on the Right Side of Head when CoughExcruciating Pain on the Right Side of Head when Cough). The patient was hospitalized on 06-Apr-2021 due to ARTHRALGIA, HEADACHE and HYPERTENSION. At the time of the report, HYPERTENSION (High Blood Pressure 200/110 mmHg), HEADACHE (Excruciating Severe Headache (After Second Shot)/Excruciating Pain on the Right Side of Head), ARTHRALGIA (Pain in the Right Side of the Neck and Right Shoulder), ASTHENIA (No Energy,Not myself), FEELING ABNORMAL (Not Myself" (After Second Shot)), INSOMNIA (she is not able to sleep at night from the Pain) and COUGH (Excruciating Pain on the Right Side of Head when CoughExcruciating Pain on the Right Side of Head when Cough) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 200/110 (abnormal) 200/110 mmHg. On an unknown date, Computerised tomogram: normal (normal) normal. Treatment with IV pain medications and was held in dark room in the Emergency room for several hours and discharged. This case concerns a 62-year-old female hospitalized with serious unexpected events of hypertension, headache, arthralgia, and nonserious unexpected asthenia, feeling abnormal, insomnia, and cough. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-092739 (E2B Linked Report).; Sender's Comments: This case concerns a 62-year-old female hospitalized with serious unexpected events of hypertension, headache, arthralgia, and nonserious unexpected asthenia, feeling abnormal, insomnia, and cough. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-092739:Case for dose 1
62 2021-05-04 fainting Dizziness, fainting
62 2021-05-05 pulmonary embolism, loss of consciousness Developed blood clot on my left lung
62 2021-05-06 arrhythmia, palpitations Uncontrolled projectile vomiting 20 hours/ temp 101.4/Diarrhea/migraine/extreme fatigue/sore throat... Read more
Uncontrolled projectile vomiting 20 hours/ temp 101.4/Diarrhea/migraine/extreme fatigue/sore throat/joint pain as if someone was sticking a machete and elbow and ankle Joints/ heart arrhythmia and palpitations . my first vaccine these effects lasted for a continuous 10 days without subsiding.... I seriously was thinking about not taking the second shot their reactions were that bad!
62 2021-05-06 atrial fibrillation atrial fibrillation (not sure when started, still continuing, scheduled for cardioversion on May 27,... Read more
atrial fibrillation (not sure when started, still continuing, scheduled for cardioversion on May 27, 2021) minor side effects - chills, nausea, extreme fatigue (probably due to a-fib), also (don't laugh) a lot of burping (not normal for me), frequent need to urinate for about 24 hours - these minor issues all cleared up within 48 hours other than fatigue
62 2021-05-06 chest pain The day after I received the first dose of my vaccine, I felt numb on my tongue, around my mouth, an... Read more
The day after I received the first dose of my vaccine, I felt numb on my tongue, around my mouth, and hands. In addition, I also experienced a low fever. Then on the third and fourth day, I stated to feel numb on my arms, thighs, fingertips and the bottom of my feet. I also started to feel chest pain, back pain, and experience migraines. I've felt very tired throughout this time, had a dry mouth. The tops of my feet and hands were slightly swollen and my veins were much more prominent as well. The palm of my hands are always very warm and have a visibly pink color. During this time frame, I've seen also seen my GP twice. As of today, overall, all of these symptoms have lessened in severity. Although the feeling of numbness has also lessened in severity as well, the slight feeling of numbness is still present as of today-especially on my tongue (23 days after my first dose of the vaccine).
62 2021-05-06 heart rate increased On 4/30/21 the patient contacted JCHD to report symptoms experienced after receiving the second dose... Read more
On 4/30/21 the patient contacted JCHD to report symptoms experienced after receiving the second dose of Moderna 4/22. She reported on 4/23 she experienced a fever of 102.1, resting HR 120. Very weak. Saturday into Sunday (4/24-4/25) she developed blisters on her nose into her nose and her lips. Feels it may be cold sores. She is a MS patient and did speak with her physician about getting the vaccine.
62 2021-05-06 pulmonary embolism, oxygen saturation decreased Pulmonary Embolism - desaturating to the 70's on admission, requiring 4L NC oxygen supplementation a... Read more
Pulmonary Embolism - desaturating to the 70's on admission, requiring 4L NC oxygen supplementation and heparin gtt
62 2021-05-07 deep vein blood clot, pulmonary embolism, superficial blood clot, platelet count decreased Patient admitted to hospital after 2-3 days of shortness of breath and calf pain, swelling in foot d... Read more
Patient admitted to hospital after 2-3 days of shortness of breath and calf pain, swelling in foot distal to calf with pain. Admission date 4/23, vaccinated with second moderna dose on 4/12 Two clots identified: right lower extremity DVT "Positive study for acute DVT in the right lower extremity, extending from the calf veins up through the right external iliac vein. Positive study for acute superficial thrombophlebitis involving the imaged lesser saphenous vein." and PE: "Acute pulmonary embolism involving the main pulmonary arteries (saddle pulmonary embolism) and extending to the lobar, segmental branches bilaterally with some extension of the subsegmental branches in the right lower lobe, overall worse in the right lower lobe with occlusive segmental branches. " Was initially started on lovenox when admitted, switched to Eliquis, no IVC filter was placed discharged in stable condition on 4/26, Of note: Patient had bone marrow biopsy of right iliac crest of April 15th 2021 - carries diagnosis of chronic lymphocytic leukemia but is currently in remission
62 2021-05-07 blood clot Blood clot. PT had blood clot removed at hospital.
62 2021-05-09 chest discomfort Patient had an allergic reaction to moderna vaccine dose 2. Pt started having tightness of chest and... Read more
Patient had an allergic reaction to moderna vaccine dose 2. Pt started having tightness of chest and hyperventilation. BP was 159/80 hr 117 o2 100%. Pt given benadryl IM 50mg. Pt started complaining of shaking and progessively got worse. Epipen was administered. 911 was called. Ambulance came within 5 mins of epipen administration
62 2021-05-09 deep vein blood clot developed DVT RLE
62 2021-05-11 loss of consciousness Vomited up my dinner the night I had the vaccine. After it began I could not keep down a bite of a ... Read more
Vomited up my dinner the night I had the vaccine. After it began I could not keep down a bite of a cracker or a sip of liquid without vomiting it right back up. This lasted for 3 1/2 weeks. Passed out once and was severely dehydrated. Had a horrible hospital experience that did not help me at all, even with fluid by IV that was not properly given. Went to see Primary a week later with same symptoms and he gave me a shot of Zofran which lasted about 1 1/2 days where I was able to eat a small amount of food and some liquids. Severe vomiting continued for another week and a half.
62 2021-05-12 cerebrovascular accident, ischaemic stroke Acute Ischemic Stroke / Cerebrovascular Accident right-sided weakness, pressure behind right eye and... Read more
Acute Ischemic Stroke / Cerebrovascular Accident right-sided weakness, pressure behind right eye and right sided headache. inability to grasp with right hand and keep right leg up. denies recent illness
62 2021-05-12 chest pain 2nd Moderna vaccine administered at 1:29 pm. - Patient has anaphlaxis with ibuprofen. Due to patien... Read more
2nd Moderna vaccine administered at 1:29 pm. - Patient has anaphlaxis with ibuprofen. Due to patient's allergies, she was observed for 30 minutes. - When patient was called to leave at 1:59, she complained of dizziness and nausea. - She admitted to not eating anything or drinking any water today. - Patient was given cold water and ice applied to back of patient's neck. - She was also food. Patient refused food and refused to drink water - Reports that she feels like she is going to pass out. - Patient requested that her son be called. Her son was called as requested and he came to clinic. - Patient refused to elevate her feet and kept trying to stand up. - Denies hx of DM or cardiac hx. - Vitals were taken stable. - She then began to complain of worsening dizziness, nausea. Followed by abdominal pain, midsternal CP, SOB, and feeling as her throat is closing. - At 2:09pm, Epipen was ordered and administered to L thigh. - Reports that CP, SOB, and throat swelling resolved after epinephrine. - Patient was placed on 2L of O2. - Fire rescue arrived. Started IV and gave patient Zofran , checked blood glucose: 141, BP: 128/101, while waiting for ambulance to arrive. - Patient was transported via ambulance to Medical Center.
62 2021-05-12 hypertension worsening hypertension
62 2021-05-12 palpitations, heart attack heart palpatations, heaviness, flush. did not contact a doctor two weeks later I had the same symp... Read more
heart palpatations, heaviness, flush. did not contact a doctor two weeks later I had the same symptoms and heart rate as 106 without any exertion. BP was 129/74 but hear rate was 106. went to ER. diagnosed with heart attack and got a stent in Left anterior descending artery.
62 2021-05-12 blood clot Bloom clot in left arm
62 2021-05-13 heart attack, anaemia Developed severe abdominal pain 3/22/2021. Hospitalized and dx w ISCHEMIC COLITIS, MESSENTERIC ISCHE... Read more
Developed severe abdominal pain 3/22/2021. Hospitalized and dx w ISCHEMIC COLITIS, MESSENTERIC ISCHEMIA, TYPE II NSTEMI, ANEMIA and THROMBOCYTOSIS. Hospitalized 9 days
62 2021-05-13 platelet count decreased, cerebrovascular accident Developed a rare blood disorder known as TTP (Thrombotic thrombocytopenic purpura). Suffered various... Read more
Developed a rare blood disorder known as TTP (Thrombotic thrombocytopenic purpura). Suffered various strokes. Outcome is pending but doctors are predicting permeant right side paralysis and inability to communicate.
62 2021-05-16 chest discomfort Pt began to have chest tightness about 5 minutes after receiving COVID-19 vaccine. Denies shortness ... Read more
Pt began to have chest tightness about 5 minutes after receiving COVID-19 vaccine. Denies shortness of breath or difficulty breathing. States she recently found out her daughter has cancer and has a lot of stress in her life so chest tightness may be related to this. Reports she also feels like she may be having heart burn. EKG reviewed by Dr. Pt taken to APRN for exam. APRN findings noted below: Panic attack as reaction to stress (F41.0). Note: EKG and labs unremarkable. Pt. feeling better now. Has a lot of stress at home with her chronically ill daughter. Discussed coping mechanisms and good nutrition today.
62 2021-05-17 loss of consciousness About 2 hours after shot, I passed out. Became very weak, dizzy and eventually passed out. After be... Read more
About 2 hours after shot, I passed out. Became very weak, dizzy and eventually passed out. After being alerted, I slept the rest of the day. Friday night, did not sleep well and sweated profusely, never detected fever. Extreme fatigue and profuse sweating for 3 days. Saturday, same, extreme fatigue, profuse sweating, headache, dizziness. Saturday night, nausea, sweating, no rest. Sunday morning, woke late, feeling totally exhausted still, bed, clothing, hair were soaked from sweating all night. Have had all over muscle ache/pain. Skin sensitive to the touch--muscle soreness. Took a long time to be able to wake up fully--then more fatigue, sweating. Later Sunday afternoon, the symptoms primarily started easing.
62 2021-05-18 chest pain Patient stated that overnight after receiving the vaccine side effects began. She stated that she ha... Read more
Patient stated that overnight after receiving the vaccine side effects began. She stated that she had shooting and stabbing pain in her chest and felt extremely week and fell on the floor. Patient also had a headache, fever, sweats, and could not sleep. She stated the side effects only lasted for about a day and then stopped.
62 2021-05-18 heart rate increased, blood pressure decreased, chest pain She reports at first she had a low grade fever , headache, and body aches. Later on that day she fel... Read more
She reports at first she had a low grade fever , headache, and body aches. Later on that day she felt like she was going to faint. Her blood pressure was 79/58 and heart rate was 104. She had shortness of breath, anxeity, depression, and just felt "odd". She said now she gets short of breath and has a heartburn like pain in the middle of her chest.
62 2021-05-18 troponin increased I received the vaccine on 1/8/21, I was tired, dizzy, and had diarrhea, I went snowshoeing on 1/10/2... Read more
I received the vaccine on 1/8/21, I was tired, dizzy, and had diarrhea, I went snowshoeing on 1/10/21 and was tired and had diarrhea, I went snowshoeing on 1/11/21 and almost turned around (which I never do) as I was super tired, had diarrhea, and dizzy, I slept half the day 1/13/21 and was tired and congested in my nose and lungs (I thought it was bronchitis which I usually get this time of year), I missed work 1/16/21 being super tired and congested in my nose and lungs, I went for a Covid test 1/21/21, I was diagnosed with Covid 1/23/21. I went snowshoeing 3/1/21 and landed in the ED for 2 days with post-Covid breathing trouble. I still have a productive cough and will go to healthcare facility 5/24/21
62 2021-05-19 chest discomfort severe sore throat, persistent cough, respiratory/chest discomfort, chills, itchyness on my face and... Read more
severe sore throat, persistent cough, respiratory/chest discomfort, chills, itchyness on my face and neck. Tireness, Weakness.
62 2021-05-20 palpitations, heart rate increased, blood pressure increased PT EXPERIENCED INCREASED HR AND BP. HEART BEATING HARD AS WELL COMPLAINED OF TINGLING LEGS AND FEET ... Read more
PT EXPERIENCED INCREASED HR AND BP. HEART BEATING HARD AS WELL COMPLAINED OF TINGLING LEGS AND FEET DIFFICULT TO FEEL FEET
62 2021-05-21 fainting First noticeable change was faint, large, white circle at injection area that rapidly grew to form a... Read more
First noticeable change was faint, large, white circle at injection area that rapidly grew to form a large, circular , red, swollen, patch expanding well beyond injection site at @3" diameter, with an uneven border, rough on top, sensitive to touch, and increased in size for several days. Began to recede days later. Although area eventually appeared normal, had a small raise at point of injection, and remained sensitive for a period of time.
62 2021-05-21 troponin increased, chest discomfort, chest pain Trouble breathing, tightness chest - Blood pressure 200/100. Called EMS, EKG . Blood pressure rose... Read more
Trouble breathing, tightness chest - Blood pressure 200/100. Called EMS, EKG . Blood pressure rose 215/100. Sent to ER ER Record The patient presents with chest pain and shortness of breath. She states that 10 minutes after getting her first Covid vaccination, she started feeling chest pain and shortness of breath. An ambulance was summoned to the store where she was getting the immunization. They gave her 4 baby aspirin and evaluated her. She opted to come by private vehicle. The patient says that she thinks she has a UTI and that maybe the vaccine made her feel worse. She is not having any GI symptoms. She states that she felt hot and a little dizzy.
62 2021-05-22 pulmonary embolism, low blood oxigenation Bilateral saddle pulmonary embolus 12 days post 2nd Moderna vaccination, Shortness of breath worsen... Read more
Bilateral saddle pulmonary embolus 12 days post 2nd Moderna vaccination, Shortness of breath worsened 6 days after vaccination, lasting 1 week until presentation to hospital ED. Was found with severe hypoxemia, and bilateral PE and right heart strain requiring interventional radiology procedure and catheter directed thrombolytic therapy, subsequent treatment and follow-up in the ICU Initial Moderna vaccine given 04/12/2021: Vial number 0 3 0 B21A Second Moderna vaccine given 05/10/2021 file number 031 B 21A Patient described mild shortness of breath beginning 1 month prior to 1st vaccine, but significant and severe shortness of breath developing less than 1 week after 2nd vaccine
62 2021-05-23 blood pressure increased Patient reported sensation of dizziness after vaccine administration. Patient's BP was also noted el... Read more
Patient reported sensation of dizziness after vaccine administration. Patient's BP was also noted elevated 192/92.and 189/83. Patient taken to ED for further evaluation.
62 2021-05-24 coughing up blood Massive Hemoptysis
62 2021-05-25 cerebrovascular accident stroke; tested positive for Covid; Covid-19; lost bowel function; got sick 4 hours later; This spon... Read more
stroke; tested positive for Covid; Covid-19; lost bowel function; got sick 4 hours later; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included INSULIN DETEMIR (LEVEMIR) and INSULIN for Type 2 diabetes mellitus. On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced FUNCTIONAL GASTROINTESTINAL DISORDER (lost bowel function) and ILLNESS (got sick 4 hours later). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), SARS-COV-2 TEST POSITIVE (tested positive for Covid) and COVID-19 (Covid-19). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), FUNCTIONAL GASTROINTESTINAL DISORDER (lost bowel function), ILLNESS (got sick 4 hours later), SARS-COV-2 TEST POSITIVE (tested positive for Covid) and COVID-19 (Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive. The patient had stroke 2 days later to the second dose vaccination and was rushed/admitted to the ER for a while. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273. This case was linked to MOD-2021-117175 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273.
62 2021-05-25 chest pain Evening of the administered vaccine patient's left arm was hurting and for a few days after. Then p... Read more
Evening of the administered vaccine patient's left arm was hurting and for a few days after. Then pain went away and came back in severity the week of 5/16/21. Pain goes up left side of neck and left chest. Pain is throbbing in left side of neck. Denies redness or swelling. Pain is 9/10. She could not sleep last night.
62 2021-05-26 chest discomfort, chest pain Woke in a.m. with heavy pressure pain mid chest and struggling to breathe, massive headache, could b... Read more
Woke in a.m. with heavy pressure pain mid chest and struggling to breathe, massive headache, could barely walk. Got up and thought I'd better sleep somehow so tried to find best position to allow me to breathe with less pain. Up/down several times, finally got to sleep.
62 2021-05-26 heart rate increased The second day, I started experiencing consistent elevated heart rates with an average of 112. This... Read more
The second day, I started experiencing consistent elevated heart rates with an average of 112. This lasted for the better part of the day but by the next day, I was only experiencing 'episodes' of elevated HR.
62 2021-05-29 pulmonary embolism, deep vein blood clot PT RECEIVED MODERNA #1 3/17/2021. SHE BEGAN TO EXPERIENCE LEG CRAMPS ON THE LEFT 4/12/2021. SHE ... Read more
PT RECEIVED MODERNA #1 3/17/2021. SHE BEGAN TO EXPERIENCE LEG CRAMPS ON THE LEFT 4/12/2021. SHE RECEIVED MODERNA #2 4/14/2021 SHE WAS DIAGNOSED WITH LEFT LEG DVT 4/19/2021 AND STARTED ON XARELTO. SHE WAS ADMITTED 5/3/2021 AND DIAGNOSED WITH PULMONARY EMBOLI SHE HAS SEEN HEMATOLOGY DR. 5/5/2021 MANY LABS ARE PENDING
62 2021-05-30 palpitations Approximately 5 hours following the 2nd dose, I began to experience total body aches. Pain became ac... Read more
Approximately 5 hours following the 2nd dose, I began to experience total body aches. Pain became acute from head to toe, with onset of chills with fever (6 degrees above normal), racing heart, congestion, migraine from aching jaw, delirious all night. Ringing in my ears and nausea. I was very well hydrated before/after vaccine. By morning, BP was back down to 113/61, but I could still hear/feel my heartbeat in my throat. Most symptoms resolved after 24 hours, other than temperature and jaw ache.
62 2021-05-31 palpitations Less than 5 minutes after getting the vaccine, I had hot head coming from my head to me feet. The nu... Read more
Less than 5 minutes after getting the vaccine, I had hot head coming from my head to me feet. The nurses giving the vaccinations, told me to sit in a secluded area. About 15 minutes later, my heart started racing, a nurse took my BP it was around 180ish. They gave me a bottle of water and one bar of granola. After 30 minutes they checked my BP again and then they called the paramedics and I went to the ER. When I got to the ER they took blood work, an EKG, a urine sample, and they gave me IV fluids. They ruled out a heart attack. I was there for about 8 hours and left around 8:30pm. I didn't work the next day, but 7-8 days after I had a persistent headache. My PCP just told me to stay hydrated and take ibuprofen. It went away after a week.
62 2021-06-01 anaemia, haemoglobin decreased blood transfusion; Hemoglobin dropped from 12 to 6; Feeling unwell; anemia; This spontaneous case wa... Read more
blood transfusion; Hemoglobin dropped from 12 to 6; Feeling unwell; anemia; This spontaneous case was reported by a consumer and describes the occurrence of TRANSFUSION (blood transfusion), HAEMOGLOBIN DECREASED (Hemoglobin dropped from 12 to 6), MALAISE (Feeling unwell) and ANAEMIA (anemia) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. Concomitant products included LOSARTAN, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and LAMOTRIGINE (LAMICTAL) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TRANSFUSION (blood transfusion) (seriousness criterion hospitalization), HAEMOGLOBIN DECREASED (Hemoglobin dropped from 12 to 6) (seriousness criterion hospitalization), MALAISE (Feeling unwell) (seriousness criterion hospitalization) and ANAEMIA (anemia) (seriousness criterion hospitalization). At the time of the report, TRANSFUSION (blood transfusion), HAEMOGLOBIN DECREASED (Hemoglobin dropped from 12 to 6), MALAISE (Feeling unwell) and ANAEMIA (anemia) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reportedly, patient's hemoglobin dropped from 12 to 6 after receiving her first dose of the Moderna COVID-19 vaccine on 03-March- 2021. Patient said about a week and half after receiving the vaccine, she was not feeling well. She is anemic. Two weeks prior to receiving the vaccine, her blood work showed her hemoglobin was 12. According to reporter two weeks after receiving the vaccine, she received a call and she was asked to go to the emergence room since her labs was showing her hemoglobin has dropped to 6. She went to the emergency room and she received blood transfusion. Patient said she went to the hospital maybe on the 14-Mar-2021 and she was in the emergency room for two days. At the time of the call, patient confirmed that she was doing fine and her hemoglobin was back to 12 which was her normal. According to the patient her doctors said they do not think this is from the vaccine. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
62 2021-06-01 chest pain, palpitations, chest discomfort Lymph node in both armpits neck on both sides of groin area were swollen for weeks; Heart felt like ... Read more
Lymph node in both armpits neck on both sides of groin area were swollen for weeks; Heart felt like skipping a beat for no reason; Itchy neck area; Rash /hives neck area; Achy joints; Low grade fever; Chills; Achy neck/throat area; Chest pain with burning sensation; Loose stools; Sore gums; GI issues; Bloody diarrhea; Ringing/ hum noise in ear/ felt like indides were tremoring; Nausea; Joint and muscle aches over entire body; Didn't feel good/ felt awful; Not getting 2nd dose; Heacy feeling in chest; Bad headache; Fatigue; Mildly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 927A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis (Arthritis in numerous joints) since 2005, Sulfonamide allergy, Bee sting hypersensitivity, Latex allergy, Hashimoto's disease since 1992, Hypothyroidism since 1992, Vitiligo since 1968, Ulcer since 1985 and Migraine since 1999. Concomitant products included IBUPROFEN for Arthritis, LIOTHYRONINE SODIUM (CYTOMEL) for Hypothyroidism, ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine. On 20-Mar-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced CHEST DISCOMFORT (Heacy feeling in chest), FEELING ABNORMAL (Didn't feel good/ felt awful), PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) and FATIGUE (Fatigue). 20-Mar-2021, the patient experienced HEADACHE (Bad headache). On 21-Mar-2021, the patient experienced MYALGIA (Joint and muscle aches over entire body). On 23-Mar-2021, the patient experienced TINNITUS (Ringing/ hum noise in ear/ felt like indides were tremoring) and NAUSEA (Nausea). On 24-Mar-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhea) (seriousness criterion medically significant) and GASTROINTESTINAL DISORDER (GI issues). On an unknown date, the patient experienced NECK PAIN (Achy neck/throat area), CHEST PAIN (Chest pain with burning sensation), DIARRHOEA (Loose stools), GINGIVAL PAIN (Sore gums), PAIN IN EXTREMITY (Mildly sore arm), PRURITUS (Itchy neck area), SWELLING (Lymph node in both armpits neck on both sides of groin area were swollen for weeks), EXTRASYSTOLES (Heart felt like skipping a beat for no reason), RASH (Rash /hives neck area), ARTHRALGIA (Achy joints), PYREXIA (Low grade fever) and CHILLS (Chills). On 20-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) had resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (Bloody diarrhea), TINNITUS (Ringing/ hum noise in ear/ felt like indides were tremoring), NECK PAIN (Achy neck/throat area), CHEST PAIN (Chest pain with burning sensation), CHEST DISCOMFORT (Heacy feeling in chest), GINGIVAL PAIN (Sore gums), FEELING ABNORMAL (Didn't feel good/ felt awful), PRURITUS (Itchy neck area), SWELLING (Lymph node in both armpits neck on both sides of groin area were swollen for weeks), EXTRASYSTOLES (Heart felt like skipping a beat for no reason), RASH (Rash /hives neck area), ARTHRALGIA (Achy joints), PYREXIA (Low grade fever), CHILLS (Chills), MYALGIA (Joint and muscle aches over entire body) and FATIGUE (Fatigue) outcome was unknown, DIARRHOEA (Loose stools), GASTROINTESTINAL DISORDER (GI issues), NAUSEA (Nausea) and HEADACHE (Bad headache) had not resolved and PAIN IN EXTREMITY (Mildly sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient didn't went to the physician. Patient experienced sore gums with two sores that were bleeding which lasted for 48 hours. Patient had been to the dentist and had a routine cleaning in Jan 2021. No treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Product dose omission issue for mRNA-1273, lot # 927A21A with associated AEs. Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21 May 2021 included patient demographics, historical conditions, concomitant medications, additional events, outcome of the events was updated and the case was updated to serious case dur to the event diarrhoea haemorrhagic.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Product dose omission issue for mRNA-1273, lot # 927A21A with associated AEs.
62 2021-06-02 chest pain Patient developed sudden onset SOB and chest pain within 12 hours of s\p vaccination. Her son called... Read more
Patient developed sudden onset SOB and chest pain within 12 hours of s\p vaccination. Her son called 911- she was in ER for 4-5hrs and ER staff told her this was vaccine related. Patient will not receive dose #2
62 2021-06-02 loss of consciousness, cerebrovascular accident have not received second dose; terrible feeling/ feeling off; No strength; No strength to walk; leth... Read more
have not received second dose; terrible feeling/ feeling off; No strength; No strength to walk; lethargic; had vomited; lost control of bowels; tingling all over my body; Stroke; completely lost consciousness; Seizure; barely move her arm; lightheaded; sick to my stomach/ Stomach issues; arm was painful; interrupted her sleep; vaccination was given directly into the infected area; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), LOSS OF CONSCIOUSNESS (completely lost consciousness) and SEIZURE (Seizure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Spider bite. On 15-Apr-2021 at 7:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was painful), INSOMNIA (interrupted her sleep), DIZZINESS (lightheaded), GASTROINTESTINAL DISORDER (sick to my stomach/ Stomach issues), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccination was given directly into the infected area) and HEADACHE (headache). On 16-Apr-2021, the patient experienced MONOPARESIS (barely move her arm). On 17-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (completely lost consciousness) (seriousness criterion medically significant), SEIZURE (Seizure) (seriousness criterion medically significant), PARAESTHESIA (tingling all over my body) and ANAL INCONTINENCE (lost control of bowels). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (have not received second dose), FEELING ABNORMAL (terrible feeling/ feeling off), ASTHENIA (No strength), GAIT DISTURBANCE (No strength to walk), LETHARGY (lethargic) and VOMITING (had vomited). On 15-Apr-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccination was given directly into the infected area) had resolved. On 16-Apr-2021, INSOMNIA (interrupted her sleep) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), LOSS OF CONSCIOUSNESS (completely lost consciousness), SEIZURE (Seizure), DIZZINESS (lightheaded), FEELING ABNORMAL (terrible feeling/ feeling off), GASTROINTESTINAL DISORDER (sick to my stomach/ Stomach issues), ASTHENIA (No strength), PARAESTHESIA (tingling all over my body), GAIT DISTURBANCE (No strength to walk), ANAL INCONTINENCE (lost control of bowels), LETHARGY (lethargic), HEADACHE (headache) and VOMITING (had vomited) outcome was unknown, PRODUCT DOSE OMISSION ISSUE (have not received second dose) had resolved and PAIN IN EXTREMITY (arm was painful) and MONOPARESIS (barely move her arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: inconclusive (Inconclusive) inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient's left arm was already itchy and swollen from a spider bite. Pharmacist injected arm where the spider bite was located, even though she noted the spider bite. During the night her arm was painful and interrupted her sleep. The next day, she could barely move her arm and it was very painful. The patient was transported to hospital emergency room. IVs and CT scan for over two weeks followed were performed. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient demographics, new serious events ,new non serious events added. event outcome of painful arm( unknown to not recovered), and arm discomfort( unknown to not recovered) were changed.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
62 2021-06-02 palpitations A few hours after the shot I started to swell up and I took some Benadryl. The morning after the vac... Read more
A few hours after the shot I started to swell up and I took some Benadryl. The morning after the vaccine I woke up and my face was very swollen. My lips, ears, my nose and everything and Benadryl was not working. After consulting with the Pharmacist, I went to the ER. I was given Steroids and antihistamine. I also went to the doctor because I was experiencing heart palpitations which started a few days after the vaccine. That lasted for two weeks. Emergency Room Hospital 04/06/2021
62 2021-06-03 heart attack She got her vaccine, she came home and started noticing some pain and burning. She looked down and ... Read more
She got her vaccine, she came home and started noticing some pain and burning. She looked down and she had a big red bump the size of a nickel or a little large, flat. Then about an hour later it started to raise, and every 4 days they started going away and then come back with more of them. They are hot, red and raised and itchy when they come on. She is still getting them, popping up on her while I was talking to her. She subsequently got the 2nd vaccine on 3/26/21, LOT#028A21A. She said that now when they come since the 2nd vaccine they come in bunches 3-5 of them come up at a time. She did call her doctor and saw Dr. who gave her Triamcinolone cream to use. She then saw her provider and gave her some stronger cream to use. The one that she got from him last relieves the itching and pain and also takes hydroxyzine and he's also given her betamethasone diproprionate cream which again relieves the pain but does not get rid of anything according to her, they still continue to come back. They are now popping up every day. When it first started it was every 4 days, and then they would go away and then they would pop up again. Now, they are popping up every day. Her left side of her face swelled on one side and went numb on 4/25/21. She then went to the doctor on 4/27/21 and he told her that it came from the vaccine. Her face is still swollen on the left side. He did not give her anything for that. She went and had an echocardiogram on 5/19/21 and they called with the results yesterday and told her that she had a myocardial infarction, but she did not know when. Her PCP told her to just continue taking the medications that she is already taking. She is supposed to go back for a FU on 7/29/21. She cannot sleep and is getting aggravated that these bumps will not go away. They look bad and she has pictures of what they look like. She would like somebody to tell her doctor what to do to treat her symptoms so that they will go away and not come back.
62 2021-06-06 cerebral haemorrhage Stroke symoton inckuding fiund brain bloid clot loss of peripheral vussion left side numbness side o... Read more
Stroke symoton inckuding fiund brain bloid clot loss of peripheral vussion left side numbness side of face habds fibger tips confusion
62 2021-06-07 chest discomfort headache 10 min after injection-tired and heavy chest within 2 hrs of injection-unable to sit up due... Read more
headache 10 min after injection-tired and heavy chest within 2 hrs of injection-unable to sit up due to lack of energy-slept through the night-next day I was dizzy, and exhausted with difficulty in breathing-chills and fever-all my joints ached-slept all day and night-third day was able to walk around the block-still sluggish-no chills or fever or aching on third day-fourth day after vaccination (vaccine admin on Monday @ 1:15-Friday morning back to normal) 100% back to normal
62 2021-06-07 fluid around the heart, palpitations, hypertension I received Moderna shots as follows: o March 18, 2021 - Dose #1 o April 15, 2021 - Dose #2 o COVID-1... Read more
I received Moderna shots as follows: o March 18, 2021 - Dose #1 o April 15, 2021 - Dose #2 o COVID-19, Moderna dose #1 (lot 045A21A) was administered as in injection in my Right arm on 03/18/21 at. o The next morning (3/19/21), I experienced tremor/pulling type sensation in my right lower lip / jaw area that lasted a few seconds, then subsided. o COVID-19, Moderna dose #2 (lot 022B21A) administered as in injection in my Right arm on 04/15/21 at. o The next morning (4/16/21), I woke up to Left side jaw pain that lasted several hours, then subsided. Mid-morning of that same day, I experienced a strong spasm type pain in my Left leg (inner groin area to knee area), lasting a few seconds, then subsided. That same day I felt tired and experienced a loss of appetite. o Over the next few weeks, I felt an unusual lack of energy and little appetite, resulting in weight loss.
62 2021-06-08 chest discomfort Moderna COVID-19 Vaccine EUA Pain in upper arm at ejection site & slight redness. Started same day ... Read more
Moderna COVID-19 Vaccine EUA Pain in upper arm at ejection site & slight redness. Started same day some residual (5+ days) Compete exhaustion with severe headache. Started day after on 6-4-2021 some residual still occurring 6/9/2021 (6 + days) Nausea. Started day after on 6-4-2021. Some traces on 6-5-2021 (2 days) Cough. Started three days after on 6-5-2021 some residual still occurring (5+ days) Feeling of heaviness in chest. Started on 6-5-2021. (lasted 1/2 day)
62 2021-06-08 loss of consciousness 24 hrs after initial dose of Moderna vaccine, I QUITE SUDDENLY, felt EXTREMELY ill. I immedently dro... Read more
24 hrs after initial dose of Moderna vaccine, I QUITE SUDDENLY, felt EXTREMELY ill. I immedently drove home and literally passed out in my front hallway. whwn I came to my senses, I realized that I, obviously had a nigh fever-103.4! Phoned my friend (live alone0 since I was somewhat DELILIOUS -we went to Hospital ER. I was "treated and released". 48 hours later I was (Sunday afternoon). I was forced to go to an Urgent Care facility, as the injection site had developed cellulitis. i was given a 10 day regimine of Ceftin (broad spectfum antibiotic) to combat the infection. NO ONE SHOULD HAVE A VACCINE AT THIS FACILITY! I HAD TO INSIST THAT THE ADMINISTRATOR OF THE VACCINE "WIPE DOWN/DECOMMI
62 2021-06-09 cerebrovascular accident several strokes occurred from April 9, 2021 thru April 24th, 2021 resulting in hospital stays both d... Read more
several strokes occurred from April 9, 2021 thru April 24th, 2021 resulting in hospital stays both dates. patient has lost some peripheral vision and cannot drive at this time. Dizzy, light headed. Feels like in a fog all the time.
62 2021-06-11 hypertension, heart flutter, palpitations, lightheadedness, chest pain I received the first Moderna vaccine on March 15, left arm hurt to touch, couldn't lift it overhead,... Read more
I received the first Moderna vaccine on March 15, left arm hurt to touch, couldn't lift it overhead, had sound halucinations and fatigue. On the eleventh day things got ugly. Sharp chest pain and jaw pain, blood pressure 130/104 (my normal is 125/60), for four days couldn't eliminate but a small amount of urine, dizzy spell-almost passed out, vitreous detachment in eye, lost taste and smell 24 hrs (test for covid-19 was negative), blood pressure jumped to 180/112, temp 94.4, TMJ/node pain and swelling three weeks, teeth didn't occlude four days and couldn't get floss between any teeth for a day (so weird), severe shooting wrist pain, couldn't hold a pen or type for 24 hrs, hand tremors, sound halucinations of metal scrapping, hammering, thumping when laid down, super itchy rash under armpit one week, occipital node swollen, top of head painful to touch, ankle swollen, pounding heart beat, dry cough, oxygen readings of 88, sub- normal temperature 94.8 to 95.8 for several days and a month of very high blood pressure readings with tinnitus, fatigue, cloudy thinking and speech. Most reactions lasted a day up four days, all were on the right side of my body, most resolved before the next started. The longest ongoing issue is high blood pressure. Finally went down to 124/66 but not consistently. Spent three weeks around 138/104 and when walking uphill, heart would start pounding, felt faint, nauseated, head ached and had difficulty breathing. Alcohol and salt triggered a reaction or made blood pressure jump to 180/104. Leaning forward to do yard work or and strenuous activity like walking made heart pound violently, head ache, and blood pressure go up. Laying down makes heart flutter. Most of the symptoms listed are for myocarditis. Once the CDC reported that kids were having these issues I reduced activity and and more bed rest and am feeling slightly better.
62 2021-06-12 chest pain My reaction to the Moderna 2nd dose, was significant. I was sick with a fever and flu like symptoms,... Read more
My reaction to the Moderna 2nd dose, was significant. I was sick with a fever and flu like symptoms, but felt better after a few days, but not 100pct. About 7 days later I had a deep pain just under my left shoulder blade, like a muscle or torn rib but more intense, about 3 days later I developed a painful and itchy rash on my right shoulder Blade. I remember feeling extraordinarily exhausted, extreme headaches and brain fog so bad that I could not focus, concentrate or remember what I was doing. I lost my temporary job because I was unable to comprehend or remember things. I was able to get into the doctor who confirmed it was Shingles. They gave me a steroid and anti viral. The rash went away, but the lethargy, weakness, and radiating pain in my back, right shoulder, neck and arm and chest is still there.
62 2021-06-12 low blood pressure Dx of concern: New diagnosis of adrenal insufficiency with symptom onset 1 day after second COVID19... Read more
Dx of concern: New diagnosis of adrenal insufficiency with symptom onset 1 day after second COVID19 vaccination. Onset Nausea, vomiting, diarrhea , weakness within 24 hours of second COVID19 vaccination. Seen ER 4/21/2021 with temp 100.4, BP 144//92, HR 122. Treated with ondansetron and phenobarbital and d/c'd home. Office visit 4/27/21, pt reported weakness 10lb wt loss, poor appetite, exam notable for orthostatic hypotension. Office visit 5/7/2021, only symtom of weakness, again orthostatic.
62 2021-06-12 increased heart rate, cardiac arrhythmia, chest pain 30-40min after 2nd Moderna Vaccination I became lightheaded, rapid HR, intense chest pain in center ... Read more
30-40min after 2nd Moderna Vaccination I became lightheaded, rapid HR, intense chest pain in center of chest, SOB, light headed, cotton mouth, and extreme fatigue. Went to outpatient Surgery center next to where I got the vaccine. Dr checked my O2 sats which were 85%, listened to lungs and heart and heard no problems, BP Normal, HR fast but regular. I immediately could not stay awake due to extreme fatigue and slept for 2 hrs, then was better for 1 hr with minimal chest pain. Then got muscle/body aches & fatigue continued & slept another 3 hrs. Through night a lot of muscle/body aches, & severe headache. Continued chest pain in middle of chest (2-3 hr duration relieved by Aleve & Hydrocodone), also SOB with minimal exertion & fatigue continued.
62 2021-06-13 blood pressure decreased I received the vaccine in the afternoon and did fine in the evening aside from a low grade fever. Th... Read more
I received the vaccine in the afternoon and did fine in the evening aside from a low grade fever. The next morning at 10:30 AM I experienced severe nausea and my BP was dropping. I was taking care of a patient at work at the time. I went ahead and got the nurses to take care of my patient. I laid down for a little until the nausea passed The entire time I was very fatigued. I slept for an hour in my car. Then went back to work. I went home at 1:30PM because I felt so bad. I slept when I got home and into the next day. I had nausea, vomiting and diarrhea. I called in sick on Thursday and Friday and stayed in bed the whole time. I also had a swollen lymph node in my right clavicle area. I was still sick in bed all weekend all through Tuesday. The entire time I also experienced shortness of breath. I still experience the shortness of breath. The shortness of breath was so bad I couldn't go a few feet to grab something with out having to take a rest. The shortness of breath has gotten me to a point where wearing a mask is difficult for me which was never the case. After having surgery, My stats kept dropping which is unusual for me. I also experienced pain in my shoulders. It feels like I am carrying a heavyweight backpack on my shoulder. I also am now experiencing chest wall pain. If I move around, I feel pain. It got to a point where I had to take a pain pill from my surgery and that did not help. I am scheduled for a echo on Thursday.
62 2021-06-14 blood pressure increased chiils backpain no taste or smell no energy
62 2021-06-14 fainting moderate to severe fainting spell; tingling in legs and hands; profuse sweating; chills; This sponta... Read more
moderate to severe fainting spell; tingling in legs and hands; profuse sweating; chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (moderate to severe fainting spell) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Jun-2021 at 2:10 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PARAESTHESIA (tingling in legs and hands), HYPERHIDROSIS (profuse sweating) and CHILLS (chills). On 04-Jun-2021 at 12:15 PM, the patient experienced SYNCOPE (moderate to severe fainting spell) (seriousness criterion medically significant). On 04-Jun-2021, SYNCOPE (moderate to severe fainting spell), HYPERHIDROSIS (profuse sweating) and CHILLS (chills) had resolved. At the time of the report, PARAESTHESIA (tingling in legs and hands) outcome was unknown. It was reported the patient did not go to ER but did consider calling an ambulance if the initial part of the spell did not pass within another 30 minutes. No treatment and concomitant medication information reported. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
62 2021-06-15 deep vein blood clot, pulmonary embolism Saddle Pulmonary Embolism; DVT; This spontaneous case was reported by a physician and describes the ... Read more
Saddle Pulmonary Embolism; DVT; This spontaneous case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Saddle Pulmonary Embolism) and DEEP VEIN THROMBOSIS (DVT) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products UBLITUXIMAB for an unknown indication, UMBRALISIB for an unknown indication and VENETOCLAX for an unknown indication. Concurrent medical conditions included Hypertension, Mantle cell lymphoma, Leukemia (relapsed or refractory CLL/SLL) and Richter's syndrome. On 28-May-2020, the patient started UBLITUXIMAB (Intravenous) 900 milligram and UMBRALISIB (Oral) 800 milligram. On 02-Sep-2020, the patient started VENETOCLAX (Oral) 400 milligram. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criteria hospitalization and medically significant). On 24-Apr-2021, the patient experienced PULMONARY EMBOLISM (Saddle Pulmonary Embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 23-Apr-2021 to 26-Apr-2021 due to DEEP VEIN THROMBOSIS and PULMONARY EMBOLISM. The patient was treated with HEPARIN on 23-Apr-2021 for DVT, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Saddle Pulmonary Embolism) and DEEP VEIN THROMBOSIS (DVT) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Ultrasound scan: dvt (abnormal) Ultrasound of lower right extremity showed acute deep vein thrombosis, DVT.. On 24-Apr-2021, Computerised tomogram: saddle pulmonary embolism (abnormal) CT on chest with IV contrast showed a saddle pulmonary embolism .. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
62 2021-06-17 nosebleed Epistaxis that continued for 2 hours
62 2021-06-17 haemoglobin decreased I had all the symptoms were related to low hemoglobin. So I tests done. Went to ER - The day before... Read more
I had all the symptoms were related to low hemoglobin. So I tests done. Went to ER - The day before my transfusion - I had Low hemoglobin so on May 28t, I had a blood transfusion; and had another blood transfusion - on June 16th. Apparently, I have some kind of bleeding so they have to continue to do more testing.
62 2021-06-17 hypotension MD at 06/14/21 0835 Follow-Up Video Visit Progress Note Video Visit Consent: The patient has given v... Read more
MD at 06/14/21 0835 Follow-Up Video Visit Progress Note Video Visit Consent: The patient has given verbal or written consent for delivery of health care, via telehealth through a Video Visit appointment. Patient was using real-time Telehealth tools between my location and the patient's location. Prior to discussing medical issues, the patient provided informed verbal consent to perform this consultation using Telehealth tools, and all questions about the Telehealth interaction were answered. Patient confirms they are located in a safe location and within the state: Yes Patient states location at time of video visit. Patient confirmed date of birth and the phone number where they can be reached in case video visit is disconnected. In accordance with federal, state, and institutional recommendations to reduce person-to-person contact during the ongoing outbreak of Coronavirus, a scheduled in-person clinic visit was reformatted to a telehealth consultation. ASSESSMENT AND PLAN: 1. Giant cell arteritis (CMS/HCC) 2. Raynaud's phenomenon without gangrene 3. Anti-RNP antibodies present follow-up visit for giant cell arteritis with extracranial involvement with pain in extremities especially right arm, arteritis/vasculitis on CT angio, elevated markers of inflammation diagnosed 05/2021, symptoms started 2 weeks after 2nd dose of COVID vaccination Raynaud's phenomena, weakly positive RNP antibody currently on prednisone 40 mg daily, Actemra 162 mg subcutaneous injection once a week. Doing better on current treatment. No active inflammatory arthritis appreciated. No signs or symptoms for active vasculitis. Reviewed results of the blood work with normalization of markers of inflammation, improvement in thrombocytosis, rest of the blood counts look okay. Discussed potential treatment options with the patient and plan to repeat markers of inflammation later this week and lower the dosage of prednisone to 30 mg daily for 2 weeks, then 20 mg daily. - Comprehensive blood work as listed below -based on results, lower the dosage of prednisone to 30 mg daily for 2 weeks, then 20 mg daily -continue with Actemra 162 mg subcutaneous injection once a week - ESR, ERYTHROCYTE SEDIMENTATION RATE; Future - C REACTIVE PROTEIN, INFLAMMATORY; Future - ESR, ERYTHROCYTE SEDIMENTATION RATE - C REACTIVE PROTEIN, INFLAMMATORY - CBC WITH AUTOMATED DIFFERENTIAL; Future - AST, ASPARTATE AMINOTRANSFERASE; Future - ALT, ALANINE TRANSAMINASE; Future - CREATININE; Future - ESR, ERYTHROCYTE SEDIMENTATION RATE; Future - C REACTIVE PROTEIN, INFLAMMATORY; Future 4. Long term current use of systemic steroids Side effects including increased risk of infections, weight gain, cataracts, glaucoma, worsening hyperglycemia/diabetes, gastric ulcers, thinning of skin, bruising, osteoporosis,etc discussed with the patient. Patient advised to consider taking vitamin D3 supplementation over-the-counter 5. Encounter for long-term (current) use of high-risk medication Check blood counts, kidney and liver function tests periodically for drug toxicity monitoring for Actemra TB QuantiFERON negative Return in about 1 month (around 7/14/2021). Counseled Patient regarding medication(s) side effect(s), diagnostic results, impressions, prognosis, risks and benefits of treatment options MD ___________________________________________________________________ HPI- Patient is a 62 year old female and presents for chief complaint of follow-up visit for giant cell arteritis with extracranial involvement with pain in extremities especially right arm, arteritis/vasculitis on CT angio, elevated markers of inflammation diagnosed 05/2021, symptoms started 2 weeks after 2nd dose of COVID vaccination Raynaud's phenomena, weakly positive RNP antibody currently on prednisone 40 mg daily, Actemra 162 mg subcutaneous injection once a week Interval Events- Patient states she is feeling much better as compared to before. She has noticed improvement in pain in her arms as well as blood pressure readings at home. She feels a little shaking in the morning on prednisone and has been doing somewhat better than before. She is feeling puffiness in her face. Brain fog present. She has been sleeping okay at night. Rest of her joints are feeling okay with no pain, no skin rashes. No fever/chills, night sweats. No significant headache, jaw pain. Rheum ROS: Constitutional: As stated in history of present illness PHYSICAL EXAM: Physical Exam General Appearance: Alert, cooperative, no distress, appears stated age Respiratory: In no apparent respiratory distress, no visibile retractions, no audible wheezes, speaks in full sentences Skin: visualized areas of normal color, without pallor or rubor Musculoskeletal: No swelling visible at MCPs, PIP, wrists, good fist making LABS/IMAGING: I reviewed the following test results with the patient. Lab Results Component Value Date WBC 15.9 (H) 06/02/2021 RBC 4.25 06/02/2021 HGB 12.0 06/02/2021 HCT 36.7 06/02/2021 MCV 86.4 06/02/2021 MCH 28.2 06/02/2021 MCHC 32.7 06/02/2021 RDW 14.7 06/02/2021 PLT 431 (H) 06/02/2021 DIFFTYP Automated 09/19/2019 NEUTP 60.5 06/02/2021 LYMPHP 33.3 06/02/2021 MONOSP 5.6 06/02/2021 EOSP 0.4 06/02/2021 BASOP 0.2 06/02/2021 NEUTABS 4.4 09/19/2019 LYMPHABS 2.2 09/19/2019 MONOSABS 0.5 09/19/2019 EOSABS 0.2 09/19/2019 BASOABS 0.0 09/19/2019 Lab Results
62 2021-06-18 body temperature decreased Three weeks and one day following my second vaccine, I had three episodes of disequilibrium followed... Read more
Three weeks and one day following my second vaccine, I had three episodes of disequilibrium followed by a drop in body temperature. I went to the ER and was admitted for a day for tests. CTs, MRIs, echocardiogram, PT consult, neurology consult showed nothing. I believe it may be vaccine related because the exact same thing happened to a friend across the country 3 weeks after her vaccine. We have been gone since.
62 2021-06-22 cerebrovascular accident patient has lost peripheral vision and can not drive anymore.; Patient has had about 8 strokes from ... Read more
patient has lost peripheral vision and can not drive anymore.; Patient has had about 8 strokes from the date of administration of the vaccine till date; This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Patient has had about 8 strokes from the date of administration of the vaccine till date) and VISUAL FIELD DEFECT (patient has lost peripheral vision and can not drive anymore.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Patient has had about 8 strokes from the date of administration of the vaccine till date) (seriousness criterion medically significant). On an unknown date, the patient experienced VISUAL FIELD DEFECT (patient has lost peripheral vision and can not drive anymore.) (seriousness criterion disability). At the time of the report, CEREBROVASCULAR ACCIDENT (Patient has had about 8 strokes from the date of administration of the vaccine till date) and VISUAL FIELD DEFECT (patient has lost peripheral vision and can not drive anymore.) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient has had about eight strokes from the date of vaccine administration till date of report. The patient had their blood pressure controlled and had not yet taken the second dose. She is unable to drive. Concomitant products were not provided/unknown. Treatment was reported as palliative care. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded This case was linked to MOD21-109853 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
62 2021-06-23 chest pain, inflammation of the heart muscle Very sick next day missed work. 10 days after had jaw, neck, chest, pain sweating dizzy went to urge... Read more
Very sick next day missed work. 10 days after had jaw, neck, chest, pain sweating dizzy went to urgent care did ekg and sent me to ER
62 2021-06-24 chest discomfort Per pt's agent, Pt had arm pain going down her Right arm (vaccine given in Right deltoid) within 15 ... Read more
Per pt's agent, Pt had arm pain going down her Right arm (vaccine given in Right deltoid) within 15 minutes of receiving vaccine. Pt left after 15 minutes (pt did not notify us of anything wrong, and went straight to her PCP). Pt's agent said within 1 hour of the vaccine, pt was experiencing arm pain that radiated to neck, shaking, headache, heavy feeling of chest accompanied by shortness of breath, general muscle pain, and worsening of her carpal tunnel. pt agent said PCP gave pt benadryl shot, and prescribed pt hydroxyzine and diazepam (which were promptly picked up by pt agent to be delivered to the pt). Pt relayed all the above information to us as she was on the phone with the pt during this whole conversation. We will follow up with pt today.
62 2021-06-27 chest discomfort, heart rate increased Shortness of breath and dizziness with normal activity and at rest Persistent dry cough Recurring ra... Read more
Shortness of breath and dizziness with normal activity and at rest Persistent dry cough Recurring rapid heartbeat, weighty feeling in chest Fatigue. Needing to rest every few minutes Bubbling feeling/sound in upper chest
62 2021-06-28 inflammation of the heart muscle, chest pain, troponin increased per discharge summary pt given covid vaccine 6/21/21. experienced nausea, vomiting, diarrhea, fever... Read more
per discharge summary pt given covid vaccine 6/21/21. experienced nausea, vomiting, diarrhea, fever,. These symptoms went away within a day then on 6/25/21 pt was at work and experienced sharp chest pain, shortness of breath, and dizziness. Positive troponin mildy elevated. Discharged at stable condition 25 hours later. Followed up with PCP (MD.) Pt diagnosed with myocarditis.
62 2021-06-28 inflammation of the heart muscle Developed Myoelectric colon paralysis .Myocarditis. Stomach swelling .
62 2021-06-29 pulmonary embolism, deep vein blood clot Pt states 05/22/2021 ER visit, mult-pulmonary clots in both lungs, also blood clot found in left l... Read more
Pt states 05/22/2021 ER visit, mult-pulmonary clots in both lungs, also blood clot found in left leg. Hemoglobin 6.2, blood transfusion, 75 O2, 06/04/2021 ER visit 4 days of observation hospitalized. Per Dr. 2 months out of work.
62 2021-07-01 heart rate increased Excelerated heart rate on numerous occasions starting in April, 2021 and included an emergency run b... Read more
Excelerated heart rate on numerous occasions starting in April, 2021 and included an emergency run by ambulance to Hospital in state. At that time heart rate was 167. I have had numerous tests run with no final diagnosis so far.
62 2021-07-03 loss of consciousness Awoke morning of 01/26/2021 with fever, chills, muscle aches, sore throat; dizzy and lightheaded on ... Read more
Awoke morning of 01/26/2021 with fever, chills, muscle aches, sore throat; dizzy and lightheaded on standing. Able to maintain fluid good intake and output. Symptoms persisted throughout the day - could not stand for more than 1-2 minutes without becoming profoundly lightheaded, resolving on lying flat in bed - passed out collapsed on floor returning from bathroom at approx. 10pm that evening. B/P by home machine 60/40; EMS called - unable to record standing B/P d/t dizzyness on standing, heart rate 122.. transported to ER. Normal saline 2L IV bolus given. Symptoms resolved and discharged home.
62 2021-07-05 cerebrovascular accident dose 1 4/4/21, dose 2 5/5/21, had a stroke on 6/1/21, no underlying conditions known, suspects possi... Read more
dose 1 4/4/21, dose 2 5/5/21, had a stroke on 6/1/21, no underlying conditions known, suspects possibly from vaccine, since then has relly ry eyes and is still in therapy from post- seizure
62 2021-07-06 chest pain, coughing up blood Onset of sharp, shooting chest pains at anterior left upper chest and anterior right lower chest as ... Read more
Onset of sharp, shooting chest pains at anterior left upper chest and anterior right lower chest as well as mild wheezing within 1 hour of vaccine administration on 2/17/21. This continued daily until an episode of hemoptysis on 5/11/21, for which she was admitted for inpatient management.
62 2021-07-07 blood pressure increased Within 10min of administration, patient began to complain of a tingling, "crawling" feeling in her r... Read more
Within 10min of administration, patient began to complain of a tingling, "crawling" feeling in her right arm where she received the shot. I had her try to move her arm a bit to distribute the dose. Then the tingling/crawling feeling spread to her right scapula, then the entire right arm and right face. Her blood pressure was elevated 156/87. She admittedly has not taken her HTN meds in a year. Patient was sitting in an office chair and began to feel dizzy, lightheaded and onset of a headache. When she said that her vision was starting to get black, I layed her to the floor and called EMS. Then her right leg also started to feel tingling. Patient was sent to the ED via ambulance and admitted to the hospital for code stroke.
62 2021-07-08 blood pressure increased, chest pain Two hours after, my feet caused me extreme pain. Then I got extreme abdominal pain and migraine, vis... Read more
Two hours after, my feet caused me extreme pain. Then I got extreme abdominal pain and migraine, vision blurred; couldn't see straight, and vomiting and couldn't eat. I moaned and cried for two days and I had to go to hospital ER finally, was there for four days and they discharged me and I was still in extreme abdomen pain, chest pains and migraines and still had blurred vision etc; blood pressure was way up and was still vomiting and couldn't eat; my blood pressure was way down and so I went to my doctor (a day later after discharge) and she said I needed to be back in the hospital, a different hospital, for five days, and was hospitalized for 9 days all together. I have lost 16 lbs and I was already a small person. I just talked to the gastroenterologist and she is putting me on another antibiotic to treat the c-diff because I still have stomach cramps. We're getting it cleared with insurance company because it's $5,000 a dose. I have only gained three pounds back and that is in the last week or two. I still don't have an appetite. I have a left leg that is swollen, that started six weeks ago. It gets worse towards the end of the day, I'm on my feet constantly during the day.
62 2021-07-10 fainting On May 19th, approximately 6:00pm, I collapsed while out walking with my husband. He said I was unr... Read more
On May 19th, approximately 6:00pm, I collapsed while out walking with my husband. He said I was unresponsive, my eyes rolled back in my head, my skin color turned gray and he could not detect a pulse or respiration. He and a neighbor called 911 and started CPR on me. I came to as the rescue unit arrived. Transported to Hospital via rescue unit where they started and IV.
62 2021-07-12 heart failure, ejection fraction decreased Started having worsening shortness of breath, exertional dyspnea, paroxysmal nocturnal dyspnea 3 da... Read more
Started having worsening shortness of breath, exertional dyspnea, paroxysmal nocturnal dyspnea 3 days after 2nd dose of COVID 19 modern a vaccine. transthoracic echocardiogram showed heart failure with reduced EF of 20-25%.
62 2021-07-12 chest pain I had no symptoms immediately after vaccine except I tired out a little earlier than normal that day... Read more
I had no symptoms immediately after vaccine except I tired out a little earlier than normal that day. I week later, I noticed the swelling and the pain. It started my entire foot, ankle, calf and knee. Foot was swollen but it did go down. I didn't think about it right off. I think it started in my right foot but it spread to my left foot and ankle, calf and knee. So both swelled and were painful for awhile. It just went down a little - the pain and swelling. It didn't go completely away but it was better. After the second vaccine, on April 7th,Lot # 038B21A - I got really bad about seven or 8 days past the second vaccine (COVID vaccine). I swelled up severely. My knees were so bad you couldn't see them. The pads of the feet were so swollen. I had no wrinkles in my feet because they were so swollen. I was putting them up to elevate them as much as I could. I had a lot of problems with it. Both legs were severely swollen and painful. I was having a lot of pain with it. It scared me. I had a few pains in my chest, too. At the 10 days range after the second vaccine, the hands started swelling and the wrist and up my arm - the injection site didn't swell instead of my arm started swelling. The pain got so bad in my hands. I told me doctor. I couldn't walk around. The pain radiating was really bad - I tried icing and elevating and nothing was working. I even bought a pair of boots (medical support) to keep the blood circulating. As soon as I have the feet down even for an hour the pain and swelling just starts right back up. My hands are hurting, too. I started having numbing in the fingers, whole hand and into my wrist. The doctor put me on generic Lasix 20 twice a day mg but for the last week or two weeks, we had to double it because my feet were so huge. My ankles are starting to discolor it's so bad. The doctor gave 10 mg Potassium tablets extended relief. He increased the Potassium when we increased the Lasix so that I take two Potassium - one in am and one in pm. It did not relieve the symptoms. It took the swelling down a hair but it's still real bad. I'm still having all the same issues - hands are numb and swollen now from talking on the phone.
62 2021-07-13 inflammation of the heart muscle, chest pain Myocarditis; Chest pain; Pain in jaw; Neck pain; Dizziness; Hyperhidrosis; Impaired work ability; Ma... Read more
Myocarditis; Chest pain; Pain in jaw; Neck pain; Dizziness; Hyperhidrosis; Impaired work ability; Malaise; This case was received. (Reference number: 1423608) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021. This regulatory authority case was reported by a health care professional and describes the occurrence of MYOCARDITIS (Myocarditis), CHEST PAIN (Chest pain), PAIN IN JAW (Pain in jaw), NECK PAIN (Neck pain), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), IMPAIRED WORK ABILITY (Impaired work ability) and MALAISE (Malaise) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054czia) for COVID-19 vaccination. The patient's past medical history included Fibromyalgia. Concurrent medical conditions included Hypothyroidism, Hypercholesterolemia and Arthritis. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), OMEPRAZOLE, MICONAZOLE and ROSUVASTATIN for an unknown indication. On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), PAIN IN JAW (Pain in jaw) (seriousness criteria hospitalization and life threatening), NECK PAIN (Neck pain) (seriousness criteria hospitalization and life threatening), DIZZINESS (Dizziness) (seriousness criteria hospitalization and life threatening), HYPERHIDROSIS (Hyperhidrosis) (seriousness criteria hospitalization and life threatening), IMPAIRED WORK ABILITY (Impaired work ability) (seriousness criteria hospitalization and life threatening) and MALAISE (Malaise) (seriousness criteria hospitalization and life threatening). At the time of the report, MYOCARDITIS (Myocarditis), CHEST PAIN (Chest pain), PAIN IN JAW (Pain in jaw), NECK PAIN (Neck pain), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), IMPAIRED WORK ABILITY (Impaired work ability) and MALAISE (Malaise) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, Catheterisation cardiac: abnormal (abnormal) abnormal. On 14-Jun-2021, Electrocardiogram: abnormal (abnormal) abnormal at Urgent Care and abnormal (abnormal) abnormal in Emergency Room. On 16-Jun-2021, Echocardiogram: confirmed myocarditis (abnormal) Confirmed myocarditis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Other concomitant medications were listed as armor thyroid. No treatment was reported for these events. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
62 2021-07-13 palpitations Palpitations
62 2021-07-19 chest pain, palpitations, inflammation of the heart muscle, palpitations Feeling abnormal; Somnolence; Chest pain; wondered if I had myocarditis; redness at the site of bice... Read more
Feeling abnormal; Somnolence; Chest pain; wondered if I had myocarditis; redness at the site of biceps; Occasional palpitations,episode of palpitations for about 20 minutes; dry eyes; inner aspects of arm, biceps were swollen and red; Myalgia; Pyrexia/low grade fever; Swelling,neck swelling; Extrasystoles; Back achiness; Pain; chills; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (wondered if I had myocarditis) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical information was provided. Concomitant products included VITAMIN B COMPLEX, PROBIOTICS NOS, BIOTIN, VITAMIN C [ASCORBIC ACID] and ASCORBIC ACID, COPPER, TOCOPHERYL ACETATE, XANTOFYL, ZINC (OCUVIT [ASCORBIC ACID;COPPER;TOCOPHERYL ACETATE;XANTOFYL;ZINC]) for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced BACK PAIN (Back achiness), PAIN (Pain) and CHILLS (chills). On 08-May-2021, the patient experienced EXTRASYSTOLES (Extrasystoles). On 09-May-2021, the patient experienced SWELLING (Swelling,neck swelling). On an unknown date, the patient experienced MYOCARDITIS (wondered if I had myocarditis) (seriousness criterion medically significant), FEELING ABNORMAL (Feeling abnormal), SOMNOLENCE (Somnolence), CHEST PAIN (Chest pain), ERYTHEMA (redness at the site of biceps), PALPITATIONS (Occasional palpitations,episode of palpitations for about 20 minutes), DRY EYE (dry eyes), PERIPHERAL SWELLING (inner aspects of arm, biceps were swollen and red), MYALGIA (Myalgia) and PYREXIA (Pyrexia/low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLU-MEDROL) at an unspecified dose and frequency; ACRIVASTINE (BENADRYL [ACRIVASTINE]) at an unspecified dose and frequency and PREDNISONE at a dose of Prednisone 40 milligram 5 days. At the time of the report, MYOCARDITIS (wondered if I had myocarditis), BACK PAIN (Back achiness), PAIN (Pain), FEELING ABNORMAL (Feeling abnormal), SOMNOLENCE (Somnolence), CHEST PAIN (Chest pain), EXTRASYSTOLES (Extrasystoles), ERYTHEMA (redness at the site of biceps), SWELLING (Swelling,neck swelling), PALPITATIONS (Occasional palpitations,episode of palpitations for about 20 minutes), DRY EYE (dry eyes), PERIPHERAL SWELLING (inner aspects of arm, biceps were swollen and red), MYALGIA (Myalgia), PYREXIA (Pyrexia/low grade fever) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use information were provided by reporter that includes bone health. 7May2021 she received the 2nd dose and that night on Saturday as she woke up to an episode of palpitations for about 20 minutes and had a low grade fever. Says around that Sunday into Monday following receiving the 2nd dose the inner aspects of arm, biceps were swollen and red. Nurse went to the emergency room for swelling of both arms and palpitations and states when she was in the ER the nurse felt the underside of her neck which was swollen also. Says she was given solu-medrol, Benadryl and was prescribed 40mg of Prednisone for 5 days. By day 4 of the prednisone she reports she had very dry eyes. Nurse states she "wondered if I had myocarditis" and went to cardiologist and the doctor did an echocardiogram and stress test, which the results were inconclusive. Now she needs a nuclear scan, which the insurance company will not cover, agent provided program information Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time. This case was linked to MOD-2021-114592 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Followed up received on 13-JUL-2021 that contains significant information that includes laboratory data ( stress test, echocardiogram and nuclear scan ), treatment medication updated that includes Treatment 40mg of Prednisone for 5 days, solu-medrol, and Benadryl. events were updated. that includes myocarditis; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.
62 2021-07-19 palpitations typical fever and body ache, triggered sinus problem, 3 rounds of antibiotics, very weak heart palpi... Read more
typical fever and body ache, triggered sinus problem, 3 rounds of antibiotics, very weak heart palpitations
62 2021-07-21 heart attack, hypotension Low Blood Pressure; Had a heart attack; Very Dizzy; Hot; Very Weak; Very Sick; Eye Color changed; sh... Read more
Low Blood Pressure; Had a heart attack; Very Dizzy; Hot; Very Weak; Very Sick; Eye Color changed; sharp pain behind the right eye; COVID ARM From injection site to elbow; COVID ARM Itchy From injection site to elbow; Swollen Lymph Node; COVID ARM Red Rash From injection site to elbow; COVID ARM Red Rash From injection site to elbow; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Had a heart attack) and HYPOTENSION (Low Blood Pressure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced ILLNESS (Very Sick), EYE COLOUR CHANGE (Eye Color changed ), EYE PAIN (sharp pain behind the right eye), LYMPHADENOPATHY (Swollen Lymph Node), VACCINATION SITE ERYTHEMA (COVID ARM Red Rash From injection site to elbow) and VACCINATION SITE RASH (COVID ARM Red Rash From injection site to elbow). 28-Apr-2021, the patient experienced VACCINATION SITE REACTION (COVID ARM From injection site to elbow) and VACCINATION SITE PRURITUS (COVID ARM Itchy From injection site to elbow). On 14-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (Had a heart attack) (seriousness criteria hospitalization and medically significant), DIZZINESS (Very Dizzy), FEELING HOT (Hot) and ASTHENIA (Very Weak). On an unknown date, the patient experienced HYPOTENSION (Low Blood Pressure) (seriousness criterion hospitalization). The patient was hospitalized from 14-Jul-2021 to 16-Jul-2021 due to HYPOTENSION and MYOCARDIAL INFARCTION. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Rash, at a dose of 1 dosage form. On 30-Apr-2021, ILLNESS (Very Sick), VACCINATION SITE REACTION (COVID ARM From injection site to elbow), VACCINATION SITE PRURITUS (COVID ARM Itchy From injection site to elbow), LYMPHADENOPATHY (Swollen Lymph Node), VACCINATION SITE ERYTHEMA (COVID ARM Red Rash From injection site to elbow) and VACCINATION SITE RASH (COVID ARM Red Rash From injection site to elbow) had resolved. On 16-Jul-2021, MYOCARDIAL INFARCTION (Had a heart attack) had resolved. At the time of the report, HYPOTENSION (Low Blood Pressure), DIZZINESS (Very Dizzy), FEELING HOT (Hot) and ASTHENIA (Very Weak) outcome was unknown and EYE COLOUR CHANGE (Eye Color changed ) and EYE PAIN (sharp pain behind the right eye) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Myocardial necrosis marker: high (High) HIGH. On an unknown date, Blood pressure measurement: low (Low) low. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided by the reporter. Patient reported that her eye color changed from hazel to blue and reported to have a yellow ring around the blue color. She also stated that when she fell dizzy and hot while doing the yard work she called in 911 for ambulance and was transported to emergency room and thereon was hospitalized. Patient reported that the paramedics did not give her any medication for her low blood pressure. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
62 2021-07-25 hypertension I have received a new diagnosis of high blood pressure and now receiving medication for it.
62 2021-07-26 chest discomfort Breakthrough case after full vaccination. Patient developed symptoms 7/19/21 including fever, chest ... Read more
Breakthrough case after full vaccination. Patient developed symptoms 7/19/21 including fever, chest tightness, cough, SOA, nausea, loss of taste/smell, nasal burning, head congestion, sneezing, and rash to trunk
62 2021-07-26 coughing up blood Bronchitis; Pharyngitis; Coughed up blood; Hoarse voice; Treatment non compliance; Inappropriate rou... Read more
Bronchitis; Pharyngitis; Coughed up blood; Hoarse voice; Treatment non compliance; Inappropriate route of vaccination; This spontaneous case was reported by a health care professional and describes the occurrence of BRONCHITIS (Bronchitis), PHARYNGITIS (Pharyngitis), HAEMOPTYSIS (Coughed up blood) and DYSPHONIA (Hoarse voice) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product MACITENTAN for Primary pulmonary hypertension. Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included TADALAFIL (ADCIRCA) and RIVAROXABAN (XARELTO) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form and MACITENTAN (Oral) 10 mg. On an unknown date, the patient experienced BRONCHITIS (Bronchitis) (seriousness criterion hospitalization), PHARYNGITIS (Pharyngitis) (seriousness criterion hospitalization), HAEMOPTYSIS (Coughed up blood) (seriousness criterion hospitalization), DYSPHONIA (Hoarse voice) (seriousness criterion hospitalization), TREATMENT NONCOMPLIANCE (Treatment non compliance) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). The patient was hospitalized from 28-May-2021 to 01-Jun-2021 due to BRONCHITIS, DYSPHONIA, HAEMOPTYSIS and PHARYNGITIS. At the time of the report, BRONCHITIS (Bronchitis), PHARYNGITIS (Pharyngitis), HAEMOPTYSIS (Coughed up blood), DYSPHONIA (Hoarse voice), TREATMENT NONCOMPLIANCE (Treatment non compliance) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, Blood pressure measurement: low (Low) Low. On 28-May-2021, Oxygen saturation: low (Low) Low. For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
63 2020-12-31 blood pressure increased, palpitations, heart rate increased Approximately 18 minutes after vaccine was administered I felt dizzy, lightheaded, heart racing, flu... Read more
Approximately 18 minutes after vaccine was administered I felt dizzy, lightheaded, heart racing, flushed, tongue felt thick. Blood pressure immediately elevated along with heart rate. I was taken to the emergency room. They performed a EKG and gave me IV decadron and Benadryl.
63 2021-01-03 blood pressure increased After 10 mins dry mouth occurred. After 15 mins compulsive swallowing occurred and dry mouth contin... Read more
After 10 mins dry mouth occurred. After 15 mins compulsive swallowing occurred and dry mouth continued. Blood pressure elevated. Observation of swelling then 2 Benadryl were given. BP monitored. After about 15 minutes or longer swallowing slowed down some. BP did start coming down. A friend came to get me and I took 2 more Benadryl about 4 hours later due to swallowing issues again. After about 6 hours after that took more Benadryl and the the next 2 days just as needed about every 8 to 10 hours Started chills with highest temperature was 99.4. K Legs felt heavy the morning after the vaccine and I felt very tired with some short bursts of Nausea
63 2021-01-03 blood pressure increased Pt received COVID19 vaccine and was observed for 15 minutes afterwards and no immediate reaction occ... Read more
Pt received COVID19 vaccine and was observed for 15 minutes afterwards and no immediate reaction occurred. As pt was walking to her car to leave she noted that she was very thirsty and she attempted to drink water in her car but felt a constant need to swallow with a feeling of PND. She returned to the observation area in the health dept. Vital signs obtained and elevated BP 204/99, HR 104, R 20 even and unlabored. Denied tongue swelling and no facial edema noted. Denied difficulty breathing. Continued to swallow water successfully but still had a feeling of PND. No coughing noted and denied having any illness prior to injection. Does have a history of chronic sinusitis and asthma but no recent problems noted. Pt given Benadryl 50mg p.o. and friend was called for transport. Continued to monitor for 1 hr before leaving with friend.
63 2021-01-03 excessive bleeding EE received Covid-19 Moderna vaccine on 12/29/20 at 5:10 p.m. at Covid vaccination site. 12/30/20 at... Read more
EE received Covid-19 Moderna vaccine on 12/29/20 at 5:10 p.m. at Covid vaccination site. 12/30/20 at 3:00 a.m.EE had pain in left side, hip and leg waking EE up from sleep . Lesions times two, one on hip and one on posterior upper leg. MD insructed EE to double Vitamin C orally and to place Bacitracin on the two lesions, which at first appeared to contain bloody drainage. Lesions are now dry. VAERS document completed.
63 2021-01-04 arrhythmia, fainting, blood pressure decreased Approx. 5 hours after vaccine an arrhythmia began + lasted through next day. UpoN waking + standing,... Read more
Approx. 5 hours after vaccine an arrhythmia began + lasted through next day. UpoN waking + standing, I experienced multiple near - syncopal episodes throughout the day. Arrhythmia continued with decreased blood pressure. No fever, vomiting or diarrhea.
63 2021-01-04 chest pain, blood pressure increased Had itchy throat scratchy voice burning in chest lightheaded and elevated BP 10 minutes after injec... Read more
Had itchy throat scratchy voice burning in chest lightheaded and elevated BP 10 minutes after injection. Next day pain and left arm and injection site blood pressure remains elevated and lightheadedness Next day still pain in arm elevated blood pressure nausea Headache and still have all symptoms 7 days later except pain at injection site
63 2021-01-06 chest pain Chills,low grade fever for 2 days,body pain from neck to knees for 7 days. Some pain still exists bu... Read more
Chills,low grade fever for 2 days,body pain from neck to knees for 7 days. Some pain still exists but is getting better.
63 2021-01-08 fast heart rate Dizziness, Fever, Tachycardia, lightheaded Narrative:
63 2021-01-10 hypertension Patient received vaccine and approximately 15 minutes later began endorsing blurry vision and dizzin... Read more
Patient received vaccine and approximately 15 minutes later began endorsing blurry vision and dizziness while sitting in observation room. Found to be hypertensive in 200/100s. Pt remained hypertensive and was transferred to ED about an hour after initial vaccination.
63 2021-01-11 blood glucose increased Second day after shot , feverish chills and uncontrollable blood sugars ( over 300) no matter how mu... Read more
Second day after shot , feverish chills and uncontrollable blood sugars ( over 300) no matter how much consul in I toll very difficult to get a normal baseline number. Fever was as hig as 102.7two days after injection, and returns in night to 101. Chills, achy.
63 2021-01-11 hypotension, heart rate decreased low blood pressure 85/52 pulse 102 continued to be low in the 80/55 the 1st day, 2nd day was 81/59 t... Read more
low blood pressure 85/52 pulse 102 continued to be low in the 80/55 the 1st day, 2nd day was 81/59 to 96/62 finally normal on the 12th. also, flared up asthma.
63 2021-01-11 pallor, heart rate decreased Possible vasovagal syncope 6 hours past the adminstration. Lasted for 30 minutes. Symptoms include... Read more
Possible vasovagal syncope 6 hours past the adminstration. Lasted for 30 minutes. Symptoms included extreme warmth (felt like whole body was on fire), dizzyness - laid down immediately so did not faint, nausea, lowered heart rate (44), unsure of blood pressure, paleness. Cold compresses and laying down and raising legs was helpful.
63 2021-01-12 chest pain day 1 ?..12 hours following vaccination. chills. within 30 minuteslater, vomiting. The vomiting cont... Read more
day 1 ?..12 hours following vaccination. chills. within 30 minuteslater, vomiting. The vomiting continued for 6 hours until I took Pepto Bismol. Fatigue followed with aches and pains from vomiting all night. Day 2....Slept the entire day was dehydrated and drank Pedi light no appetite had I slice of bread. Day 3 began to feel better with mild diarrhea, still experiencing aches and pains in chest and ribs from the results of the horrific vomiting. Day 4.. Feeling better than day 3 with still mild diarrhea and less aches and pains. could actually cough without feeling my lungs may implode. day 5 back to work still mild gastrointestinal issues. definitely on the mend
63 2021-01-13 hypertension, heart rate abnormal When I got home from my hike the next day of vaccination I felt my heart going crazy I had high bloo... Read more
When I got home from my hike the next day of vaccination I felt my heart going crazy I had high blood pressure 160/100 it stayed like that for the next 3 days but the next day I felt my whole body pounding I was shaky I had to go to urgent care. Then for the next week I was feeling very fatigue & short of breath lasted for about a week.
63 2021-01-14 loss of consciousness extremely dizzy, passed out, took blood pressure 3 times over 45 minutes, 56/34, 62/43, 81/56
63 2021-01-15 heart rate increased 10 minutes after receiving vaccine pt reports feeling flushed, like her heart is beating fast. Pt st... Read more
10 minutes after receiving vaccine pt reports feeling flushed, like her heart is beating fast. Pt states its the same feeling she gets when she gets novicaine at the dentist. Seat reclined in car. 1331:HR 92,BP 190/78. Pt reports baseline HTN.Monitored in car by RN.1340: Pt reports feeling better, wants to have more observation.1350: Pt sat up from reclined seat and reports return of symptoms. HR 74, BP 170/80.Continued to observe for total of 1 hour.Pt states feels much better but not 100%,encouraged pt to have someone pick her up,pt states her son is available.1430:Son arrived to drive patient's car home, pt escorted to passenger side seat by this RN without issue.
63 2021-01-18 heart rate decreased, heart rate increased Patient reports getting the COVID-19 Moderna Vaccine today at 215 patient reports driving home with ... Read more
Patient reports getting the COVID-19 Moderna Vaccine today at 215 patient reports driving home with no symptoms. Patient began working on her computer and felt a heat flash, she checked her smart watch and her heart rate was in the 170s. Patient got up to get a drink of water and called her daughter, patient reports her heart rate dropped to the 70s while she was on the phone but went back up to 130s quickly after. Patient reports no chest pain or SOB
63 2021-01-18 loss of consciousness 1/15/2021: That night after vaccine, feeling very cold, unsure of having fever and very tired. Repor... Read more
1/15/2021: That night after vaccine, feeling very cold, unsure of having fever and very tired. Reports arms and legs were burning that night. Nausous that night also. Employee took Ibuprofen. At 4:00 am, feeling better. Saturday night, 1/16, feeling the same; nauseous, burning feeling in legs and arms, and chills. Reported into work on Sunday, 1/17. Talking to coworker in breakroom and said not feeling right and passed out. Employee has no memory of event after passing out. Staff reporting employee went unresponsive, gurgling like going to aspirate. Staff tipped employee to side to prevent aspiration and took employee to emergency room to be evaluated by physician. Vitals were stable, labwork unremarkable except potassium of 3.3. Chest xray was normal. No signs of infection. Doctors determined reaction to vaccination on Friday, 1/15
63 2021-01-18 palpitations 12:17 felt heart racing, face flushes, SOB with speaking. States she feels like she is going to pass... Read more
12:17 felt heart racing, face flushes, SOB with speaking. States she feels like she is going to pass out. Taken to private observation via w/c area with EMT on site in attendance. BP 180/120; HR 100; 02 99% on room air.. States she also feels lightheaded, is having generalized shaking, especially hands trembling. No redness or swelling noted at injection site. States she did eat yogurt and granola bar at 10 am. 12:29 - drank about 2 oz water without difficulty. Denies itching, states she feels better, but is still shaking vigorously all over upper body. Denies being cold. Denies chest pain. just feels like she can't catch her breath. Still flushed in cheeks and forehead. 12:34 BP 158/100; HR 82; O2 96% on r/a. Still shaking. Covered with her sweater. 12:36 Doesn't feel like she is going to pass out anymore. Still having tremors, shaking. Unable to completely catch her breath 12:40 EMS activated. 12:42 HR 77; O2 99% on r/a . Still shaking. States Bactrim sometimes sends her sideways. States she does have a history of hypoglycemic events. 12:55 arrived. Patient still shaking and feels lightheaded again. 12:58 BP 168/90; HR 91; O2 98% r/a. POC glucose check per EMT - glucose - 85 Gave patient juice 1306 Shaking subsided. She thinks the juice helped. BP 156/86; HR 78: 99% r/a 13:07 released patient she states her SOB is gone. No more tremors. Denies lightheadedness. 13:13 Patient taken to private vehicle driven by husband.
63 2021-01-19 blood pressure increased right arm numbness/ acute flushing chest neck face ears/ shakey/ slight sob
63 2021-01-19 cerebrovascular accident, atrial fibrillation CVA the following day Patient had vaccine on 1/14/21 and was admitted to the hospital 1/15/21.
63 2021-01-20 fast heart rate, hypertension Tachycardia (180+/-) starting approx 7-10min post injection. Was taken to medical monitoring area a... Read more
Tachycardia (180+/-) starting approx 7-10min post injection. Was taken to medical monitoring area and held for approx 45min. Severe hypertension (approx 180/110 initially) was noted. Both improved over monitoring period, but did not resolved. Continuing to monitor both at home. Still experiencing random intermittent elevations to both parameters 3 days post injection. Also experiencing inj site rxn starting 12 hrs post and still present at 3 days post. Redness, swelling, pain (reducing), and now mild itching.
63 2021-01-21 fast heart rate Patient stated that she was tachycardic the night of her vaccine and then dizzy the next morning. Sh... Read more
Patient stated that she was tachycardic the night of her vaccine and then dizzy the next morning. She stated that she was dizzy but that she does suffer from vertigo already. She said these symptoms lasted about a week. On the 1/14/21 she was tachycardic, dizzy, weak and she had a raised red rash distal to the site of injection. She went to urgent care and was diagnosed with cellulitis and prescribed an antibiotic. On 1/17/21 she went back to urgent care since the rash had migrated and appeared patchier than cellulitis. Her doctor said that he did not believe it to be cellulitis at this time and prescribed her a steroid cream.
63 2021-01-25 chest discomfort c/o chest heaviness 45 mins after vaccine. assessed by provider for 30 minutes and dc'd back to work... Read more
c/o chest heaviness 45 mins after vaccine. assessed by provider for 30 minutes and dc'd back to work to follow up with pcp
63 2021-01-25 chest discomfort c/o chest tightness 45 mins post vaccine. assessed by the clinician for 45 additional minutes. d/cd ... Read more
c/o chest tightness 45 mins post vaccine. assessed by the clinician for 45 additional minutes. d/cd back to work to follow up with primary care provider.
63 2021-01-25 loss of consciousness Pt presented to clinic and reports 3-4 hours after receiving first injection she felt fatigue and no... Read more
Pt presented to clinic and reports 3-4 hours after receiving first injection she felt fatigue and noticed some swelling in her throat and a noticeable palpable lump with some difficult swallowing. This went away after a few hours. Pt woke up the next morning with abdominal pain and reports standing up and passing out. Pt states she had diarrhea throughout the day also with dizziness.
63 2021-01-25 loss of consciousness Patient age 63 presented for her second dose of moderna vaccine. She reports after 1st dose several ... Read more
Patient age 63 presented for her second dose of moderna vaccine. She reports after 1st dose several hours after injection she had fatigue and some swelling in her throat with a palpable lump and difficulty swallowing. The morning after woke up with dizziness and abdominal pain and passed out. She reported itching about 3-4 days after dose
63 2021-01-25 fainting Awakened at 0200 with severe nausea and abdominal discomfort. Got out of bed, went to bathroom and v... Read more
Awakened at 0200 with severe nausea and abdominal discomfort. Got out of bed, went to bathroom and voided. Walked back to bedside and I became diaphoretic and had a syncopal spell. My husband was able to arouse me immediately. B/P ( while flat on floor) 84/66. I hydrated and diaphoresis resolved in about 30-40 minutes. B/p improved to 114/68. Abdominal discomfort continued for several hours. Headache continued 01/26/2021.
63 2021-01-26 blood pressure decreased, loss of consciousness AFTER GIVING SHOT IN 10MIN , PATIENT STARTS FEELING UNWELL, HER JAW LOCK, STARTING UNCOUNCIOUS, SHE ... Read more
AFTER GIVING SHOT IN 10MIN , PATIENT STARTS FEELING UNWELL, HER JAW LOCK, STARTING UNCOUNCIOUS, SHE WETS HER PAINT, HER TOUNGE OUT, UNRESPONSE, HER EYES WIDE OPEN , BLOOD PRESSURE DROP LOW
63 2021-01-26 heart rate increased Dizziness, fast heartbeat, lips felt funny like they were thick, headache, and tongue felt thick.
63 2021-01-26 lightheadedness, hypertension Had tingling, hypertension, and hyperventilating 5 minutes after injection. Was place on a table in... Read more
Had tingling, hypertension, and hyperventilating 5 minutes after injection. Was place on a table in a supine position. BP was monitored and was down to 165/86 at 45 minutes after injection. Heart rate = 67 O2 Stat = 100. indicative of a vasovagal reaction. Was able to leave clinic after 1 hour and did not work the rest of the day
63 2021-01-26 fainting The patient experienced syncope after the first vaccine dose. Has been on thyroid medications for hy... Read more
The patient experienced syncope after the first vaccine dose. Has been on thyroid medications for hypothyroidism and on a long-acting beta blocker.
63 2021-01-27 chest discomfort Chills, bad aches, headache from temple to temple, possible fever, chest heaviness. Left arm 1st ... Read more
Chills, bad aches, headache from temple to temple, possible fever, chest heaviness. Left arm 1st injection site 3 in frm 2nd injection site swollen and hard as knot after second injection. Still feel light headed and clammy.
63 2021-01-27 chest pain 13 minutes after the injection, experienced an intense whole body hot flushing, increased perspirati... Read more
13 minutes after the injection, experienced an intense whole body hot flushing, increased perspiration which lasted 2-3 mins then resolved. Headache. Then felt "odd", BP was 92/47. drank 8 ounces fluid, BP slightly increased then dropped again. Felt very faint chest pain, about 8-9 deep & sharp, but resolved quickly. Returned to work. Next day at 32 hours exactly, arm injection site felt slightly achy , return of off feeling. Headaches off and on. On day 3 fatigue began, and intense injection site sharp pains which woke me at night although not apparent in day. Over next several days, intense site pain continued to wake me in middle of night, very painful. On day 7, began to feel better, but then woke that night with extremely intense pain at site. Today is day 8, I found 2 red swollen, thickened and hard, pear shaped areas 4cm x 10cm; smaller one at site and a second larger area below that, area red and warm to touch indicating a cellulitis was developing. Call to primary doctor and CDC, instructed to complete this. Now concerned about whether to obtain vaccine #2.
63 2021-01-27 heart rate irregular, hypertension Client received Moderna Vaccination at School Based Immunization Clinic at 9:20AM. Client was sent... Read more
Client received Moderna Vaccination at School Based Immunization Clinic at 9:20AM. Client was sent to the observation area after the shot for 30 mins due to history of severe allergy to Morphine (self reported). At 10:05AM, client stated to complain about a headache and feeling extremely exhausted. Client was told by the observation team to lay head on table and team alerted PHN about client. PHN came over to observation area to evaluate client. While PHN was talking with client, client stated she was very nervous about getting the shot, stated she didn't want to get another one, was shaking all over, said she was dizzy and them became limp. Client was moved to the floor for evaluation. 9-1-1 was called for EMS to arrive to school clinic. PHN took initial vitals: B/P 158/96, Pulse 120, Resp 44. Client was asked to start taking slower deep breaths to help with oxygen flow. Client started to open eyes and become more alert. Stated again she was not going to get another COVID vaccine and that she was very nervous about getting this vaccine. EMS arrived at 10:24AM. Vitals were reevaluated B/P: 146/88, Pulse: 84, Oxygen 94, Resp: 22. Client was moved to sitting in a chair and recoperating well. Still complained about being sleepy and headache. Client's husband arrived to the event and when client saw husband, she started to shake and became limp again. Client them moved to the floor again and then transferred by EMS to stretcher and transported to ER for evaluation.
63 2021-01-28 blood pressure decreased Patient was requested to wait 30 min post vaccination due to h/o reaction to morphine in the past. ... Read more
Patient was requested to wait 30 min post vaccination due to h/o reaction to morphine in the past. She stated that she is not to take any opioid. Approximately 10-15 min into her wait time she c/o tingling, hot feeling. She was laid down in a treatment room. BP 173/98. Pulse ox and pulse normal range. After a few minutes of monitoring, she sat up and became nauseaus. Her BP dropped to 130/84. She was laid back down. Dr. assessed patient. He recommended Zofran for her nauseau. RN gave her sublingual Zofran. After about 30 minutes, her BP was 140/90, and she felt "stable". She was assessed again by Dr. and released home. Nurse contacte her by phone after she returned home. She said she still "did not feel the best". We recommended that she contact her PCP as soon as possible and go to the ER/Urgent Care if she developed any severe symptoms. These were explained to her by the nurse.
63 2021-01-28 palpitations 25 min after - heart racing, couldn?t swallow, tongue swelled, hives. Had Benadryl and took immedi... Read more
25 min after - heart racing, couldn?t swallow, tongue swelled, hives. Had Benadryl and took immediately. Called doctor and went to Er where they monitored me for several hours and took ekg.
63 2021-01-30 chest discomfort, oxygen saturation decreased Allergic reaction within 10 sec. Tongue swelled, lips swelled, tingly tightness in throat and down ... Read more
Allergic reaction within 10 sec. Tongue swelled, lips swelled, tingly tightness in throat and down center of chest/digestive, tingly tightness across my shoulders. 1 Hour. Per the Center, they phoned Moderna and Benedryl 25 mg was taken. I took another 25 mg a few hours later. In addition, I went to my immunologist for follow up (9 days after Moderna Vaccine 1 reaction on 01/16/2021). He cleared my taking my monthly allergy injections. I had a worse reaction to that and never do. The Moderna Vaccine was in my system. Same symptoms but my lips swelled further, broke out in hives on chest, oxygen level fell to 91.
63 2021-01-31 hypotension 02/01/21 Patient called and states that she had low blood pressure and fatigue for 3 days approxima... Read more
02/01/21 Patient called and states that she had low blood pressure and fatigue for 3 days approximately 6 days after she received the COVID Vaccine. She states that on approximately 01/20/21 she started to have a "tingling" or "pin prick" sensation in her back. The sensation has continued to happen at different times and in different places on her back, gluteus area, arms, and legs. I recommended that she speak with her private physician about her symptoms and also whether she should receive the 2nd dose of COVID Vaccine. CA/RN
63 2021-02-01 chest discomfort Started to notice severe left-sided lumbar spine pain, severe left iliac crest pain radiating down l... Read more
Started to notice severe left-sided lumbar spine pain, severe left iliac crest pain radiating down left leg to above knee area, lymphatic edema. Treatment with acupuncture and massage therapy has helped alleviate the severity of the previous mentioned symptoms to where they are now tolerable. Slight chest heaviness and slight exacerbation of asthma symptoms which have been controlled with asthma inhalers.
63 2021-02-01 heart rate increased, blood pressure increased Elevated heart rate, elevated blood pressure, headache, nausea, increased joint pain in right should... Read more
Elevated heart rate, elevated blood pressure, headache, nausea, increased joint pain in right shoulder rotator cuff and joint pain in both Achilles tendon?s, Temperature of 101.5
63 2021-02-03 ischemic chest pain, chest pain Headache, Arthralgia, Fever, Angina, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE, CHEST PAIN Narrative: ... Read more
Headache, Arthralgia, Fever, Angina, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE, CHEST PAIN Narrative: She was hospitalized on 1/24/2021 in the AM D/C home 1/25/2021 PM for abnormal EKG. She is set up for a stress ECHO with plans follow up with PCP on 2/1/2021. She is fatigued and has headache, chest pain that is stabbing in nature has improved. She has SARS-CoV-2 test pending. CRNP She plans on returning to duty tomorrow at 0730. She is going to bring her work restriction note from her PCP. She has been directed to report to employee health for return duty evaluation CRNP 2/2/2021
63 2021-02-03 blood pressure fluctuation 6 minutes post vaccination patient reports feeling "wonky" and similar to reaction she has had after... Read more
6 minutes post vaccination patient reports feeling "wonky" and similar to reaction she has had after Xolair injection(s). Pt has own epi pen and was assisted to couch, feet elevated. Pt denies respiratory distress, no urticaria or angioedema. Pts vitals taken while recumbent on couch: O2 98%, HR 76, BP 160/100. Offered water, juice, crackers. Pt remained resting on couch; at 14:40 reports nausea and patient agrees to 12.5 mg IM diphenhydramine in opposite arm of vaccination. Pt remained resting on couch denies respiratory distress and no other s/s of anaphylaxis noted. Pt vitals taken several times while on couch ranging from 130/90 - 158/100, OZ 98% and HR 72-76. Pt remained resting on couch without further symptom progression until family member arrives to transport home 85 min post vaccination.
63 2021-02-04 heart rate increased, chest discomfort Rapid heartbeat, shortness of breath. heaviness in chest, headache, fatigue, soreness at injection s... Read more
Rapid heartbeat, shortness of breath. heaviness in chest, headache, fatigue, soreness at injection site
63 2021-02-05 fast heart rate Tachycardia started 40 minutes after administration. Resolved after patient slept. Severe depression... Read more
Tachycardia started 40 minutes after administration. Resolved after patient slept. Severe depression and crying bouts, feelings of hopelessness on day 2 and 3.
63 2021-02-06 palpitations Moderna vaccine #2 was given on Friday, January 29 at 1 PM. She had no side effects that day. On S... Read more
Moderna vaccine #2 was given on Friday, January 29 at 1 PM. She had no side effects that day. On Saturday she felt mildly achy and had a headache and stayed in bed. Sunday her heart was flip-flopping with palpitations. She noticed new dyspnea on exertion with just a short distance as well as feeling panicky. On Monday she went to work and continued to have the same symptoms. Two colleagues were vaccinated at the same time she was also reported the same symptoms of palpitations, dyspnea and new onset anxiety. Yesterday the symptoms were even worse, "really bad'. Her vital signs were checked at work and were all normal. Today she is not feeling as bad but still feels very anxious. She woke up with a headache again. She is taking ibuprofen for the HA which helps.
63 2021-02-07 palpitations Shortness of Breath, Headache, Dizziness, Chills in upper body and feet, Pain on left side of head, ... Read more
Shortness of Breath, Headache, Dizziness, Chills in upper body and feet, Pain on left side of head, coughing one day, heart pounding.
63 2021-02-07 palpitations On the second day of vaccine I had a terrible headache & nausea, 3rd day till today I have been havi... Read more
On the second day of vaccine I had a terrible headache & nausea, 3rd day till today I have been having severe dizziness & hear racing & palpitations along with nausea.
63 2021-02-08 palpitations 1-20-2021 8:30PM - sore arm 1-21-2021 8:00AM temp 98.1 sore arm only 2:25PM temp 99.8 Headache, col... Read more
1-20-2021 8:30PM - sore arm 1-21-2021 8:00AM temp 98.1 sore arm only 2:25PM temp 99.8 Headache, cold, skin sensitive to touch, fatigue, weak 4:30PM temp 101.3 Nurse checked: BP 120/80 O2 - 98 4:50PM Took 2 Reg. Tylenol Temp went down to 98.1 by 98.1 but started going up to 98.8 by 10:30PM when took 2 reg. tylenol early evening started having heart palpitations Jan. 22 and 23rd, 2021 Temp gradually going back to normal without Tylenol. Still having fatigue, weak, heart frequently skipping beats, feeling short of breath with activity Jan. 27, 2021 saw family doctor because of continued heart palpitations and shortness of breath with activity.
63 2021-02-09 blood pressure increased elevated blood pressure 30 minutes after the vaccine, systolic reached 161. resolved after 30 more m... Read more
elevated blood pressure 30 minutes after the vaccine, systolic reached 161. resolved after 30 more miutes
63 2021-02-09 blood pressure increased Blood pressure went up to 180/90 and has been high since first detected. Lifelong BP has been 120/7... Read more
Blood pressure went up to 180/90 and has been high since first detected. Lifelong BP has been 120/70.
63 2021-02-09 chest pain, chest discomfort Chest pressure developed 5-7 mins after receiving vaccination. Vitals were normal. Pt was taken to c... Read more
Chest pressure developed 5-7 mins after receiving vaccination. Vitals were normal. Pt was taken to clinic for evaluation and EKG. EKG was normal. Pt reported that her chest pressure resolved prior to being discharged from clinic. Pt was walked back to her department and while doing so did complain of feeling a little dizzy. I spoke with pt on morning of 2/10/2021 over the telephone and she reported that chest pain had not returned and dizziness had resolved. She only complaint on 2/10 was that of fatigue and mild arm soreness.
63 2021-02-10 troponin increased, cardio-respiratory arrest 02/08/21--2 days after vaccine--Resident stated that she "didn't feel good" (She is developmentally ... Read more
02/08/21--2 days after vaccine--Resident stated that she "didn't feel good" (She is developmentally delayed and less able to communicate how she feels than those in the community) and stopped eating most foods; also had fatigue. Vitals, coloring, & behavior were normal. 02/09/21--Belly was firm and mildly distended (although she stated it didn't hurt); she coded this evening and CPR was performed before EMT could transport her to the hospital. 02/10/21--Resident passed.
63 2021-02-11 blood pressure increased, heart rate increased Rapid heart rate. Increased pulse and blood pressure. Lasted about a half hour.
63 2021-02-11 chest discomfort Patient reports she developed pain, swelling and decreased range of motion the day after getting the... Read more
Patient reports she developed pain, swelling and decreased range of motion the day after getting the vaccine. She reports it lasted several days after. She has been taking Tylenol and prescription NSAID daily to ease the pain. The prescription is actually for her knees but she states she has been taking it to relieve the pain in her right shoulder. She reports now (16 days after vaccine) her range of motion has returned but she still has discomfort to pectoral and deltoid area when doing a "rowing" motion.
63 2021-02-11 hypotension, blood pressure decreased Fever, Angioedema, SkinRash, Rash, UrticariaPruritus & HYPOtension Narrative: 2nd Vaccine 2/3: with... Read more
Fever, Angioedema, SkinRash, Rash, UrticariaPruritus & HYPOtension Narrative: 2nd Vaccine 2/3: within 3 hours developed itchy rash all over, high fever 102.5 and went to ER, was admitted 2/5 discharged 2/6, blood pressure kept dropping was given IV fluids and steriods, and her legs are still swollen, hands cannot make a fist, she was swollen everywhere.
63 2021-02-11 palpitations Tingling sensation - full body; duration 5 minutes; no treatment; resolved Heart palpitations - sign... Read more
Tingling sensation - full body; duration 5 minutes; no treatment; resolved Heart palpitations - significant - started ~2 hours post injection; duration 1.5 hours (worse when resting); considered going to ER; no treatment; resolved.
63 2021-02-12 blood pressure increased, fast heart rate Started with itchy eyes (15-20 minutes afterwards), felt swelling in nose and then within approxima... Read more
Started with itchy eyes (15-20 minutes afterwards), felt swelling in nose and then within approximately 30 minutes of injection tongue felt strange and started swelling like it was getting too big for my mouth. Increased BP. Given injection of Benadryl at 4pm. and squad was called for transport to ER. Had tachachardia in ambulance BP still high. Had BP cuff on, oximeter and leads on chest. Hospital monitored me. At six was given liquid Benadryl and Pepcid as felt like symptoms getting worse. Swollen nose and roof of moth felt swollen. At one point in time male nurse said my face was red. Not sure how long that persisted. Also, sounded funny when I talked when symptoms had returned. Like I had a clothes pin on my nose and sinus clogged. After 4 hours was sent home with instructions to take Pepcid once a day for 14 days and to take Benadryl every 8 hours. About 1am I was still awake. Felt like my heart did a flUp flop for lack of better words. Few minutes later felt fluttering. 2am I?m taking Benadryl and going to sleep.
63 2021-02-12 loss of consciousness minor fever and sore arm until bedtime. I awoke about 10:30 PM with nausea and abdominal pain, even ... Read more
minor fever and sore arm until bedtime. I awoke about 10:30 PM with nausea and abdominal pain, even to the touch, higher fever, mild headache and significant thirst. When I awoke a few hours later and tried to get out of bed my feet were cramping so I couldn't stand comfortably, also achiness in ankles, hands and wrists. I was very thirsty and cold, so cold that I could not get a thermometer in my mouth as my teeth were chattering. I tried to drink some water and went back to bed. A few hours later I woke up, thirsty, kind of crawled into the bathroom. I had a 101 temperature, still nauseous and achy joints. I tossed and turned all night. When I got up at 6:15 AM I went into the bathroom, tried to drink water but was feeling very nauseous and felt like I was going to pass out. I woke up on the floor when my husband came in - he heard my head hit the floor from another room. My first instinct was for water, which he squirted into my mouth. Both of my arms and hand were tingling. He managed to help me up, and I crawled back to the bed. My temp was about 100.5 where it stayed for most of the day. I called a friend, she told me to take some ibuprofen -I can't take acetaminophen- I took one, drank lots of fluids, and spent the rest of the day sleeping on and off. I did cut my head but not significantly enough to go to a facility. I was literally unable to do anything for the entire day. When I woke up today my temperature was down to 98.1 - its normally in the 97's - and feel much better except my sore arm and aching head
63 2021-02-15 palpitations Severe nausea, chills, joint pain, headache, racing pounding heartbeat, severe weakness and fatigue,... Read more
Severe nausea, chills, joint pain, headache, racing pounding heartbeat, severe weakness and fatigue, loss of appetite. Symptoms persisted 2+ days.
63 2021-02-16 blood pressure decreased, hypotension Pt felt burning sensation in arm immediately after injection and BP dropped to 86/53 causing her to ... Read more
Pt felt burning sensation in arm immediately after injection and BP dropped to 86/53 causing her to feel as though she would faint. After lying pt. down and providing water, BP did rise to 108/70 and pt. was feeling better after 20 minutes.
63 2021-02-16 heart attack, fainting, pulmonary embolism, cardiac arrest Patient called EMS approximately 1pm on 2/15 with complaints of generalized weakness. Upon arrival E... Read more
Patient called EMS approximately 1pm on 2/15 with complaints of generalized weakness. Upon arrival EMS found her to be diaphoretic and she had a witnessed syncopal episode with question of v-fib and seizures. She became unresponsive and had no pulse. CPR was begun and she was transported to ED. She remained asystole throughout. CPR was initially continued in the ED for approximately 30 minutes and then stopped with Time of Death noted at 13:27. ED notes noted "suspect given history that patient experienced massive MI, PE or ruptured AAA". Death certificate notes indicate "signficant conditions contributing to death after cardiac arrest; ASCVD".
63 2021-02-17 palpitations 1 day after recieving vaccine - fever, chills 3 days after recieving vaccine - anxiety, racing heart... Read more
1 day after recieving vaccine - fever, chills 3 days after recieving vaccine - anxiety, racing heart, tingling nerves
63 2021-02-18 chest discomfort 15 minutes after receiving vaccination, pt reported it feels like "my throat is closing up", left si... Read more
15 minutes after receiving vaccination, pt reported it feels like "my throat is closing up", left sioded neck, arm, and chest pressure, and nausea. Pt does report she has had chest pressure intermittently for past 2 weeks but throat closing feeling began after vaccination. Pt received aspirin 324 mg po x1, diphenhydramine 25 mg IV x1, famotidine 20 mg IV x1, Solu-Medrol 125 mg IV x1, morphine 2 mg IV x1, and nitroglycerin 0.4 mg SL x1. Following treatment, pt reports she is free of chest pain and throat symptoms have improved.
63 2021-02-20 chest discomfort Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Mild, Syste... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild
63 2021-02-21 chest pain Chills 2 Days of Fever over 102.5 1 Day of Fever over 100 3 Days fever above normal Itchy Arm (after... Read more
Chills 2 Days of Fever over 102.5 1 Day of Fever over 100 3 Days fever above normal Itchy Arm (after around 5 days) Severe headache and body aches for around 3-4 days Stomach issues - could not eat for 2 days - made me sick Very weak for about 3 days Took a week to feel almost normal, but still not 100% Arm still hurts Chest pain (note - had 3 stents put in on Dec 11 due to cardiovascular blockage). Had a shooting pain the first night. Not sure if related to the vaccination or not.
63 2021-02-21 fast heart rate, palpitations, heart rate increased Started experiencing heart palpitations within minutes of receiving vaccine. Heart rate is between 1... Read more
Started experiencing heart palpitations within minutes of receiving vaccine. Heart rate is between 170-180 bpm. Patient states that she has had ?palpitations? in past but has never been diagnosed with cardiac condition. Is currently on SVT rhythm on EKG. Attempted to have patient vagal down with no change in heart rate. Patient was transferred to paramedics for transport to Medical Center.
63 2021-02-21 fast heart rate, palpitations Minutes after receiving vaccine pt started experiencing ?heart palpitations ?. Puts heart rate is be... Read more
Minutes after receiving vaccine pt started experiencing ?heart palpitations ?. Puts heart rate is between 170-180bpm and is showing SVT rhythm on EKG. Pt did vagal maneuvers with no change in heart rate. IV established and care transferred to paramedics for transport to emergency department.
63 2021-02-22 palpitations At 11am on 2/16, my arm began to get sore. I took Advil at 4pm and it wasn't so bad. At about 10pm... Read more
At 11am on 2/16, my arm began to get sore. I took Advil at 4pm and it wasn't so bad. At about 10pm when I went to bed, I had issues falling asleep because my heart felt like it was pounding through my chest. That pounding came off and on during the next day. I woke up twice and my feet were ice cold and my body was very hot. The second time I woke I thought I would take some tylenol and was extremely dizzy walking to the bathroom. I was so weak I couldn't open the bottle. I slept nine hours, very unusual. I felt very under the weather all day until around 5pm. I woke up the next morning feeling pretty normal. The arm pain was completely gone by the 18th.
63 2021-02-22 fainting I was fine til about 2am when I was faint and light headed with flu-like symptoms, stuffy nose, body... Read more
I was fine til about 2am when I was faint and light headed with flu-like symptoms, stuffy nose, body aches + terrible migraine headache. Was so sick that I was unable to find my migraine meds (prescribed by doctor). Have history of migraines but haven't had one in several month...I was dizzy and worried about thowing up and fainting. Note: usually never recieve the flu shot but not during 2020.
63 2021-02-23 chest discomfort cold sweat, ear ringing, chest tightness, nausea, cold extremities, light headed, severe headache, u... Read more
cold sweat, ear ringing, chest tightness, nausea, cold extremities, light headed, severe headache, upset stomach, fatigued
63 2021-02-23 chest pain During the waiting period after vaccine administration, employee developed dizziness, mild chest pai... Read more
During the waiting period after vaccine administration, employee developed dizziness, mild chest pain and headache. 911 was called and employee was taken to the hospital
63 2021-02-23 loss of consciousness I want to report an unusual reaction that I had to the 2nd Covid vaccination. I rec'd my 2nd vaccin... Read more
I want to report an unusual reaction that I had to the 2nd Covid vaccination. I rec'd my 2nd vaccination on 02/04/2021 @ approx. 5:15, within a few hours I started to have normal and expected reaction. Approximately 9am the next morning I passed out without any type of warning (dizziness etc) I passed out another 2 times during Friday morning. I stayed in bed the remainder of Friday, felt sluggish on Saturday and back to normal on Sunday.
63 2021-02-23 pallor Fairly sore arm day of and day after injection (though did not interfere with daily activity). Appr... Read more
Fairly sore arm day of and day after injection (though did not interfere with daily activity). Approx. 8 days after injection, noticed red patch (approx. 3"x4") below injection site. This rectangle had surprisingly straight edges and occasionally itched slightly. Six days later the rectangle is approximately the same size, but has lost its very straight edges, and has paled in color. Perhaps 10 days after the injection, some swelling was noticed in the left armpit and an intermittent discomfort like a dull pencil poking a particular spot in the armpit was experienced. The armpit swelling/discomfort lasted about 3 days.
63 2021-02-23 palpitations two hours after injection I ran across a road and my heart began to race and I felt like I couldn't ... Read more
two hours after injection I ran across a road and my heart began to race and I felt like I couldn't breathe. I slowly went into the post office and was offered a chair. It was over as fast as it hit me and everything was fine after that. No other adverse effects since then
63 2021-02-24 blood glucose increased 1/13 vaccination 3 days later, I got blurred vision. It got worse. 1/15 got worse with vision. Staye... Read more
1/13 vaccination 3 days later, I got blurred vision. It got worse. 1/15 got worse with vision. Stayed at home. Had to stop driving, double vision. 1/18 really started to get bad with vision. Been like this ever since. I have been working from home for 3 weeks now. PCP; She gave me medicine to get sugar down; Jarviance 1/21 Blood sugar went up to 495; went to ER.Opthamologist; He told me nothing he could do for me. He told me I had vision reversed due to sugar being so high. He told me he couldn't give me any glasses as when sugar decreases, the vision will go back to normal.
63 2021-02-24 chest pain After receiving vaccine the patient was waiting for her 15 min. She began to report feeling of numbn... Read more
After receiving vaccine the patient was waiting for her 15 min. She began to report feeling of numbness in her fingers. Her vitals were checked and she had an elevated blood pressure of 200/108. She was also was developing a redness on both arms and hands. Rechecking her blood pressure 5mins later her blood pressure was 190/110. Patent also had complaints of intermittent chest pain. After speaking to a provider it was decided to send patient to the ER to treat the elevated blood pressure.
63 2021-02-24 fainting, hypotension, loss of consciousness Dizziness, Fainting, Loss of Consciousness, Low blood pressure -- duration several minutes followed ... Read more
Dizziness, Fainting, Loss of Consciousness, Low blood pressure -- duration several minutes followed by fatigue resting in bed.
63 2021-02-25 atrial fibrillation Very dizzy; Threw up; Episode of afib; Light headache; A spontaneous report was received from a cons... Read more
Very dizzy; Threw up; Episode of afib; Light headache; A spontaneous report was received from a consumer (patient), 63 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, episode of A-fib (atrial fibrillation), very dizzy (dizziness), threw up (vomiting), and light headache (headache). The patient's medical history included episode of A-fib. Current conditions included diabetic and high blood pressure. No concomitant medications were reported. On 03 FEB 2021, seven days prior to the onset of events, the patient received their first of planned doses of mRNA-1273 (batch number: 038K20A), intramuscular in the left arm for the prophylaxis of COVID-19 infection. It was reported that two days ago, the patient had an episode of atrial fibrillation on 10 FEB 2021. The patient doesn't know if it was from the vaccine or something else. The patient usually has 2-3 times of atrial fibrillation a year. She didn't have any other side effects at all right after the vaccine. The patient was a diabetic and didn't call her doctor about this, because it went away. The patient described the atrial fibrillation episode as uncomfortableness and beating of the heart. The patient has an appointment with her cardiologist 2 days before her second shot, and she'd ask him about it. The patient was also wondering that the side effects occurred 8 or 9 days after the shot. She has high blood pressure and took a measurement, and it was normal at 93 (unknown units). The patient had the injection on her left arm because she has a diabetic monitor on right arm. The patient didn't take any treatment for the side effect except one time she took acetaminophen about three days ago when she had a light headache. On 12 FEB 2021, at about 10 am in the morning, the patient got very dizzy and had to sit down on the floor, and she threw up. After that, the patient was feeling fine. The patient gave consent to follow up from safety and to her doctor. No further treatment medications were reported. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of the events, episode of A-fib, and light headache were unknown and that of events very dizzy, and vomiting was recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's medical history of having 2-3 times of atrial fibrillation a year, diabetic and high blood pressure are the risk factors and confounds to the causality.
63 2021-02-25 heart rate increased Swelling of lips and face, racing pulse. 50 mg of Benadryl
63 2021-02-25 hypertension, chest discomfort 2:56 pm Post vaccination reports/ stated "feeling hot and tired" w/associated chest tightness, no so... Read more
2:56 pm Post vaccination reports/ stated "feeling hot and tired" w/associated chest tightness, no sob; BP 145/90 P8 Medical monitoring, "feeling better". 3:03 BP 135/ 57 P 80 Released to home w/ daughter.
63 2021-02-25 palpitations At night my heart started racing, I felt like coughing, I felt extreme fatigue, no chills or fever, ... Read more
At night my heart started racing, I felt like coughing, I felt extreme fatigue, no chills or fever, body aches. Muscle aches. I felt like I had covid all over again. Had COVID in June 2020 and never really stopped coughing. Since I had the vaccination it seems that the cough got a little better. I also developed Shingles after about a week or so after the vaccine.
63 2021-02-27 pulmonary embolism Individual received her COVID vaccine and had no prior symptoms. 24 hours after the injection she de... Read more
Individual received her COVID vaccine and had no prior symptoms. 24 hours after the injection she developed significant shortness of breath and was seen in the ER where she was diagnosed with bilateral pulmonary embolism.
63 2021-02-28 chest pain, blood pressure increased, palpitations at 02:45 client complained of tingling in L hand, flushed, hot, racing heart beat, nausea, headache ... Read more
at 02:45 client complained of tingling in L hand, flushed, hot, racing heart beat, nausea, headache BP 179/98, P 61, O2 98% 3:00 BP 144/97, P-63, O2 98%, 3:11 BP 122/98, P-57, O2 98%, 3:22 headache, lower jaw pain increasing to upper jaw, 3:24 BP 160/102, 156/106, refused ambulance, 3:28 transported by daughter to ER. Spoke with client the following day, client's BP went up to 284/224 while in the ER, client had arm heaviness from elbows down, shoulder blade pain, client was given metoprolol, pepcid, phenergan and steroids. Client was released at 7 pm, client went home with daughter and had chest pain and headache all night. client was doing better the next day, only complaining of headache off and on.
63 2021-02-28 palpitations pt stated that the morning after receiving the covid vax that she woke up with a tender, red lump a... Read more
pt stated that the morning after receiving the covid vax that she woke up with a tender, red lump around the injection site. She was weak and tired so went back to bed. She had loss of appetite, congestion, heart palpitations and developed chills during the night. She wakes up today 3/1/2021 weak and tired again today so went back today. She gets up about 2PM today with a red rash on her neck, shoulders, back and all of the way around to her naval. She says it looks like a shingles rash. Pt is going to contact her PCP for medical advice.
63 2021-03-02 heart flutter, palpitations 2/4/2021-Extreme rapid heart race 11:30pm until 4:00am . Skipping beats. Extreme heat sensation... Read more
2/4/2021-Extreme rapid heart race 11:30pm until 4:00am . Skipping beats. Extreme heat sensation last all day. Shaking (not a chill feeling, body shaking so bad. Felt like Gallbadder inflamed and an Ovary had pain. No fever 2/5/2021_ Heart skipping. Extreme Heat/ Body Shaky (no chills) No Fever 2-6-2021- Heart racing. Extreme heat inside of body. Red blood dots on arms, chest and back. (not like rashes) Flat to feel. Extreme heat then shaking insides felt like it was being sucked out of body. Heart flutter. Muscle jumps. No Fever 2-7-2021- Body on fire again and shaking real bad all night. Feeling like insides were being sucked out. Heat fluttering. No fever. 2-8-2021- Heart Fluttering . Heat sensation. Went to doctor. EKG was performed. Doctor advised not to get the second dose. 2-9-2021 - Brain fog . Heart Flutter. I did not feel like myself until 3 weeks later. Kinda felt like my body was off or shutting down.
63 2021-03-02 hypertension 4 days after getting the vaccine feeling extremely tired in the afternoon and like I was zoning out,... Read more
4 days after getting the vaccine feeling extremely tired in the afternoon and like I was zoning out, and have had that feeling when my blood pressure has spiked before, but this was even worse--could barely keep my eyes open and felt weird, so measured my BP, and it initially read 190/151 which could not be right, but I know it was high. I took it again a little while after, and it was down to 140/90, but usually is not that high when I've taken my full medication in the morning, which I did. I then took my Spironoloactone. BP was high for about an hour and then came down. Don't know if it's related to the vaccine, but I haven't had it spike in quite a while, especially if I have taken my full amount of Losartan (which is 50mg), and while it may not have been 190, I know it was higher than it's ever spiked because I felt worse, and I can always feel when my BP goes up. (There are days when my BP is too low to take the full pill, so I take half, but this day, I had taken the full pill.) So, as I said, not sure if it's related to the vaccine or not, but was the worst I felt during a BP spike and lasted longer than ever did as well, but then came down without having to take any more medication except the Spironolactone, but it had come down a bit before that kicked in.
63 2021-03-02 loss of consciousness All hair has fallen out; Heartburn; Nausea feeling; Passed out; Wasn't feeling right after dose; Fac... Read more
All hair has fallen out; Heartburn; Nausea feeling; Passed out; Wasn't feeling right after dose; Face was tingling; Burning feeling in head; A spontaneous report was received from a Consumer regarding a – 63Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like passed out, Wasn't feeling right after dose, face was tingling,bBurning feeling in head, devastated about hair loss after 1st dose, Heartburn and Nausea. The patient's medical history was not reported. Relevant concomitant medications were reported like amitriptyline, duloxetine, gabapentin, metformin, Nexium, hydrocodone, potassium, Proair, ropinrole, simvastatin, spironolactone, Topamax, vitamin d, vitamin b12. On 12- Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:030m20a) intramuscularly for prophylaxis of COVID-19 infection. On 12- Feb-2021, the patient experienced the event like Passed out. On an unknown, date the patient experienced events like Wasn't feeling right after dose, Face was tingling, Burning feeling in head, Devastated about hair loss after 1st dose, Heartburn nausea feeling and Nausea. Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events Passed out, Face was tingling is resolved. The outcome of the events Devastated about hair loss after 1st dose is Recovering/Resolving. The outcome of the events like Wasn't feeling right after dose, Burning feeling in head, Heartburn nausea feeling and Nausea are unkown; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 cannot be excluded. Nausea is consistent with the known safety profile of the vaccine.
63 2021-03-03 heart rate increased, blood pressure increased SWEATING, INCREASED HEART RATE, INCREASED BLOOD PRESSURE, INCREASED BODY TEMPERATURE
63 2021-03-04 chest discomfort Within 7 min. Of vaccine i began to feel like i was on a cold IV drip; the sensation started at vacc... Read more
Within 7 min. Of vaccine i began to feel like i was on a cold IV drip; the sensation started at vaccine site and traveled down my arm into my body. I then went to pharmacy desk and said i thought i was having a reaction and went to the bathroom to see if i was red in the face. Yes, my face and body were red splotchy which is my indicator of having an allergic reaction. I also noticed that my chest was feeling tight like my bra was on too tight. The pharmacist gave me a Benadryl and i waited 15 more minutes. The Benadryl relieved most of the symptoms after an hour but my chest was tight the remainder of the day and fine the next day.
63 2021-03-04 palpitations, chest pain Sunday, January 10, I woke up with a headache and it stayed all day. Later I got a scratchy throat, ... Read more
Sunday, January 10, I woke up with a headache and it stayed all day. Later I got a scratchy throat, cough, congested, chilled. Wednesday or Thursday - COVID test - that was negative. Friday night started having terrible chest pain - heartburn pain -and it went to my last side -I went to ER on January 16 - early morning got to ER - bloodwork was fine, etc. They had me start PEPSID. Cardiac Nurse Practitioner - saw her on January 25th - GI kind of pain - heart was pounding and racing constantly. I have a GI assessment planned - (Ordered by the Cardiac NP). Chills went away on 17th or 18th of January. I have a swollen gland in my neck. I never ran a fever. Temp was always normal. GI assessment will be this Tuesday, the 9th of March. (I had the second dose of vaccine on January 21.) My heart is still racing a bit. The GI pain is about gone.
63 2021-03-04 palpitations Headache started fairly quickly but not as bad as first dose. Arm was sore. No chills. Headache last... Read more
Headache started fairly quickly but not as bad as first dose. Arm was sore. No chills. Headache lasted for the rest of the day. Arm soreness lasted quite a few days - about 5 days or so. Still continuing to have heart racing and pounding and heartburn pain up in my chest. Those heart symptoms haven't gotten noticeably better until about this last week. Cardiac Nurse Practitioner - saw her on January 25th - taking PEPSID. l. GI assessment will be this Tuesday, the 9th of March - I will be having that at the medical center.
63 2021-03-08 blood pressure increased About 9 days after receiving the 1st shot on 1/15/21 a rash appeared on my chest area. Raised bump... Read more
About 9 days after receiving the 1st shot on 1/15/21 a rash appeared on my chest area. Raised bumps and non spreading. I have now received my second dose on 2/11/21 .Had reactions that occurred the next day of chills, muscle and body aches, slept for 14 hours, totally fatigued, headache on day 4 ran a fever and then symptoms decreased. except for the rash that has never went away.
63 2021-03-08 blood pressure increased Severe migraine, dizziness, nausea vomiting for 3 days
63 2021-03-09 excessive bleeding The nurse gave me shot however did not get in muscle was in subcutaneous area. Left large bruise and... Read more
The nurse gave me shot however did not get in muscle was in subcutaneous area. Left large bruise and swelling and moderate bleeding after shot. My concern is did I get enough of the vaccine in me Since this was administration error.
63 2021-03-09 hypotension, loss of consciousness Pt started to seize up, lost consciousness, and had a blank stair, she did respond to ammonia after ... Read more
Pt started to seize up, lost consciousness, and had a blank stair, she did respond to ammonia after about 15 to 20 secs, she was hypotensive and oxygen at 92%. 911 was called, they check her out. Pt refused to go hospital. Patient signed waiver. Rechecked pt Blood pressure and was within normal limits. Patient said she felt fine.
63 2021-03-09 fast heart rate I had a fever, fatigue and a headache. I became lightheaded and I became tachycardic with a heart ra... Read more
I had a fever, fatigue and a headache. I became lightheaded and I became tachycardic with a heart rate of 140. I spoke with my PCP. I rested and she prescribed for me a beta blocker to lower my heart rate. Which was effective.
63 2021-03-10 arrhythmia Face swelling and arrhythmia ; went to ER; benadryl given; heart rate normalized after IV benadryl
63 2021-03-10 chest discomfort Had an immediate headache. Five to ten minutes later left hand was numb and tingle. Blood pressure... Read more
Had an immediate headache. Five to ten minutes later left hand was numb and tingle. Blood pressure went up to 147/85 and pulse was 53. I was observed by an EMT. Last vitals were taken at 11:00. 135/82 and pulse was 53. I am not on any blood pressure meds. I called my dr. and when I was seen in December of 2020, my pressure was 116/68 and my pulse was 74. I refused to go to the hospital. on the day of the vaccine but I did go to my drs. the same day at 4:30 and my pressure was 122/80 and pulse was 54. I did not go to work the next day. I felt heaviness in my chest and my arm was sore. I was also tired. I feel better today, but still do not feel myself. My dr. recommended I get my second shot at the hospital if I possible.
63 2021-03-10 chest pain Pt started feeling SOB about 15 minutes after vaccination, feeling tingling in arms/hands. She then ... Read more
Pt started feeling SOB about 15 minutes after vaccination, feeling tingling in arms/hands. She then reported it was harder to breathe and throat was feeling weird. She was lightheaded. EPI 0.3mg administered by autoinjector, then 50mg Benadryl administered. Shortness of breathe continued and chest pain developed. Another dose of EPI administered 5 min later. EMS arrived and transported pt. to ER.
63 2021-03-11 chest pain METALLIC TASTE IN MOUTH, SWEATS, HOT TO TOUCH SKIN, BURNING IN CHEST, SLIGHT DIZZINESS WHEN THERE WA... Read more
METALLIC TASTE IN MOUTH, SWEATS, HOT TO TOUCH SKIN, BURNING IN CHEST, SLIGHT DIZZINESS WHEN THERE WAS A MOVEMENT, (LATER THAT AFTERNOON), PAIN IN LEGS, SHOT SITE REALLY SORE
63 2021-03-11 fainting nausea, headache, fever, restlessness, passing out feeling, itchy,rash, ,
63 2021-03-12 chest pain Headache Chest pains/gas pains Leg cramps Foot cramps Flank pain Exhaustion Insomnia
63 2021-03-12 loss of consciousness Very achey and light headed to the point of passing out
63 2021-03-13 anaemia About 12 hours after the 2nd Covid vaccine shot, I started throwing up. At first, once, then progres... Read more
About 12 hours after the 2nd Covid vaccine shot, I started throwing up. At first, once, then progressed to vomiting every 30 minutes, fever, soreness, and extreme headache. I went to ER and finally saw an Er doctor-he gave me fluids and zofran-then sent me home?about 6 hours later, the same symptoms and went to a different ER because I would not have to wait 3 hours to see dr. They gave me fluids, phengran, and toradol w/tylenol. He kept me long enough to make sure it had passed. The intense headache continued thru the 13 but finally better today. It was horrible.
63 2021-03-14 deep vein blood clot DVT blood clot in left calf verified via utrasound on 2/17/2021. Symptoms: pain in left calf and fo... Read more
DVT blood clot in left calf verified via utrasound on 2/17/2021. Symptoms: pain in left calf and foot proceeded by chills/fever and right fingers/hand inflammation. Symptoms began 2/08/2021.
63 2021-03-16 chest discomfort allergic reaction lip swelling SOB and chest tightness
63 2021-03-16 pulmonary embolism, chest pain Hard to breathe, chest hurt, embolism in left lung
63 2021-03-17 blood pressure increased Patient reported feeling shaky and hot. Patient was assessed and her BP was elevated (172/90, 182/94... Read more
Patient reported feeling shaky and hot. Patient was assessed and her BP was elevated (172/90, 182/94, 188/94)
63 2021-03-17 bleeding on surface of brain Pt received injection of moderna second dose on March 09. 2021. PT was found unresponsive at 1:15pm ... Read more
Pt received injection of moderna second dose on March 09. 2021. PT was found unresponsive at 1:15pm on 3/14/2021 at home. was taken via EMS to ER. PT found to have subarachnoid hemorrhage. was transferred to a critical care facility for a higher level of care. Critical care services provided in ICU pt diagnosis of diffuse SAH likely aneurysmal. pt prognosis life threatening.
63 2021-03-18 chest pain Pt had flushing and pt stated that she had chest pain. Pt was provided oxygen to ease breathing. E... Read more
Pt had flushing and pt stated that she had chest pain. Pt was provided oxygen to ease breathing. EMS was called.
63 2021-03-18 chest pain I was exposed to Covid-19 in September, but my tests were negative. I had the same chest pain as whe... Read more
I was exposed to Covid-19 in September, but my tests were negative. I had the same chest pain as when I thought I had Covid-19 on the third morning after vaccination. Started in the back with trouble breathing. I was lethargic and tired but I had a lot of trouble breathing for a week. I also took a course of Zithromax and the symptoms resolved after eight days but the tiredness persisted. I gave blood on the day of vaccination after the shot and it may have some effect.
63 2021-03-18 heart rate increased Headache, body aches, fever, chills, light-headed, nauseous, heart rate went from 92-176 in a few m... Read more
Headache, body aches, fever, chills, light-headed, nauseous, heart rate went from 92-176 in a few minutes.
63 2021-03-18 heart rate increased Rapid heart rate , SOB
63 2021-03-19 chest discomfort Within moments of injection: felt heat flush rushing from arm through chest to neck & face. Extreme ... Read more
Within moments of injection: felt heat flush rushing from arm through chest to neck & face. Extreme itching in arm, felt anxious & lightheaded. Noticed eyesight blurred. Pharmacist told me my chest & face were bright red. I felt slightly nauseous & my mouth tasted like penny's. Pharmacist administered antihistamine. By this time I had a bad headache & feeling of pressure in chest & head. I was made to sit in lobby & wait 30 min. I continued feeling strangely unwell for 8 days. My b.p. went up & I felt anxious & exhausted. Arm hurt. No temp. On day 3 ( I believe..or day 4) arm became even more painful & A round rash appeared. My chest & neck were also red again . I took pictures of my arm, chest & neck.
63 2021-03-20 chest pain Took on Friday, around 4 on Sat. started feeling bad, arm was hot & swollen, by 6 fever chills & hur... Read more
Took on Friday, around 4 on Sat. started feeling bad, arm was hot & swollen, by 6 fever chills & hurt all over, by evening numbness in both hands & feet , by 9pm headache started ? pain developed in chest, ribs & low back. Chills continued all nite as did pain all over most especially numb hands/wrist & feet. Saturday upon waking fatigue but chills were gone. Feet were better ad was right hand. Continued throughout day with shoulder, neck, rib,low back, knee & arm pain & fatique.
63 2021-03-20 cardiac arrhythmia, palpitations My highest temperature was 101.8 °. Fever lasted about 28 hours. My heart was pounding for about 6... Read more
My highest temperature was 101.8 °. Fever lasted about 28 hours. My heart was pounding for about 6 hours until I got my fever under 100° ( not sure if the fever was the cause) I was also havIng PVCs. . I was very tired and had to lay down in bed for 3 days. This includes the day of the shot and two other days. I had a headache for about 10 hours.
63 2021-03-21 chest pain, chest discomfort Red face, swelling in between lip and nose, sharp tingling in throat and interior of throat, difficu... Read more
Red face, swelling in between lip and nose, sharp tingling in throat and interior of throat, difficulty swallowing, chest tightness and a pulsing pain moving from left to right in my heart area - all of these symptoms occurred within 1/2 hour to 45 minutes of getting in car after vaccine and waiting period. That evening - had headache and general body aches and muscle tightness - next day extremely fatigued with headache (headache was mostly left side) - Symptoms clearer mostly after 2nd day after vaccine 3/19/2021 - but the most prominent symptoms were shortly after vaccine when I got into car to drive home.
63 2021-03-21 heart rate increased Evening after receiving vaccine (starting at approximately 7 PM, had slight headache, felt lighthead... Read more
Evening after receiving vaccine (starting at approximately 7 PM, had slight headache, felt lightheaded and more tired than usual; 2nd day felt fine during day, then by approximately 8 PM felt more tired than usual; but had trouble sleeping; seemed to have rapid heartbeat; and slight chills. Third day (today); fine during day, but as of approximately 7:30 PM quite tired again, and slight chills again. Sore arm at vaccination site, but not more than what I usually experience with a flu shot.
63 2021-03-21 palpitations heart palpitations ,followed by vision problems, followed by headache - total time lapse approxima... Read more
heart palpitations ,followed by vision problems, followed by headache - total time lapse approximately half hour, then goes away. Happens intermittently throughout day. No occurrences after going to bed
63 2021-03-21 fainting, heart rate increased 22 hours after being vaccinated, I fainted (approximately 7:00 AM the next day), the duration of fai... Read more
22 hours after being vaccinated, I fainted (approximately 7:00 AM the next day), the duration of fainting was more or less than a minute. The rest of the day I felt very weak. I had a fever of 37.5C. My blood pressure was normal (good), just my heart rate a little high (I usually monitor 70 and it was close to 100 for several hours after fainting). During the night before the event, I got up to urinate several times and usually I only get up once. I did not take any medications or supplements on the day of the vaccination. I also did not take painkillers after vaccination.
63 2021-03-22 fainting Wednesday night I felt tired and cold. Woke up Thursday morning and couldn't lift up my head. Migrai... Read more
Wednesday night I felt tired and cold. Woke up Thursday morning and couldn't lift up my head. Migraine was in all of top teeth, ears, behind eyes, all over head. Pain was so extreme I fainted in bed. Came to and pain was a bit better but quickly came back full force. Woke up at 1am Friday morning drenched from sweat through to the mattress but migraine was better. Ran fever up to 102 and down and up all day Friday. Saturday fever was only 100 but came back after each sweat. Sunday I had almost no fever and just a regular head ache. Monday exhausted but okay.
63 2021-03-23 excessive bleeding, loss of consciousness, hypotension Patient received the first Moderna vaccine at nine o'clock Thursday morning, felt fine until 2pm. Sh... Read more
Patient received the first Moderna vaccine at nine o'clock Thursday morning, felt fine until 2pm. She began to feel feverish, achy, nauseous, weak. All symptoms lasted through Sunday when she passed out early in the morning. We found her on the kitchen floor, having hit her head and bleeding. She was conscious and alert but a little disoriented and very weak. We called for an ambulance which took her to the same facility where she had been vaccinated. She was diagnosed with a concussion and low blood pressure (62/49). Today she still feels weak and dizzy and nauseous. She has not returned to work yet, pending recommendation from her cardiologist and PCP.
63 2021-03-23 heart rate increased Rapid Heartbeat started about 1-1/2 hours after the shot. Heartbeat was rapid for several hours and... Read more
Rapid Heartbeat started about 1-1/2 hours after the shot. Heartbeat was rapid for several hours and then intermittently for ~30 Hours. My face was flushed & hot. I started trying to look up Moderna side effects but could not find anything about rapid heartbeat until after I found the Moderna fact sheet online. I did not go to the hospital as I had no chest pains or shortness of breath. But I did take a baby aspirin 3 times over the course of the 30 hour period. I was also very fatigued during this time. The rapid heartbeat has subsided by now but I don't know if i should still get the 2nd shot which is scheduled for April 16.
63 2021-03-23 hypotension, loss of consciousness Fell after urinating and hit her head; Semi delirious and confused; Cramps were intermittent for 1-2... Read more
Fell after urinating and hit her head; Semi delirious and confused; Cramps were intermittent for 1-2 hours; Tremulous; Low blood pressure; Dizzy; Cold, clammy; Very sweaty; Severe diarrhea; Lost consciousness; Borderline in shock or in shock; Head injury; abdominal discomfort; A spontaneous report was received from a physician concerning a 63-year-old, female patient who developed severe diarrhea, abdominal discomfort, lost consciousness, fell after urinating and hit her head, cold and clammy, very sweaty, low blood pressure, semi delirious, confused, tremulous, cramps, in shock and dizzy. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 03 Mar 2021, approximately four days prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Batch number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 06 Mar 2021, the patient experienced severe diarrhoea and abdominal discomfort. At 4 AM she had lost consciousness and fell after urinating and hit her head on the curb of the shower. Her husband found her and when he saw her, she was cold, clammy and very sweaty. Her husband reported that the patient had low blood pressure that caused syncope and caused her to fall. The patient was in a semi-delirious state and was confused, tremulous. The cramps were intermittent for 1-2 hours. The patient was in a borderline shock or in shock as she was very dizzy when she stood up. The events were resolved after four hours. On the next day her temperature was at 98.8 degrees Fahrenheit. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, diarrhea, abdominal discomfort, loss of consciousness, fall, cold sweats, hyperhidrosis, hypotension, syncope, confusional state, tremors, muscle spasms, shock and dizziness were recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
63 2021-03-24 chest discomfort Achy left arm, tenderness in left armpit, pins & needles feeling in left hand, discomfort extends to... Read more
Achy left arm, tenderness in left armpit, pins & needles feeling in left hand, discomfort extends to left chest & shoulder blade
63 2021-03-24 loss of consciousness I rec'd my 2nd vaccination on 02/04/2021 @ approx. 5:15, within a few hours I started to have norma... Read more
I rec'd my 2nd vaccination on 02/04/2021 @ approx. 5:15, within a few hours I started to have normal and expected reaction. Approximately 9am the next morning I passed out without any type of warning (dizziness etc) I passed out another 2 times during Friday morning. I stayed in bed the remainder of Friday, felt sluggish on Saturday and back to normal on Sunday
63 2021-03-25 heart rate increased Extreme dry mouth & tongue swelling approx 20 min after injection Chills approx 1 hour after injecti... Read more
Extreme dry mouth & tongue swelling approx 20 min after injection Chills approx 1 hour after injection Rapid heart beat for about 2 hours - occurring approx 1 hour after injection Itching at a hard lump at injection - still itching 3 days later Hip joint pain - I have extremely bad bone density in hips - pain on left hip after 24 hours and still hurting after 3 days
63 2021-03-25 hypertension Pt describes severe sciatic never pain 1 month after receiving covid-19 moderna vaccine. Also compla... Read more
Pt describes severe sciatic never pain 1 month after receiving covid-19 moderna vaccine. Also complaining of L leg arm pain/numbness and lymph node pain/numbness. She went to ER 3/14 for sciatic and uncontrolled hypertension--tx with hydralazine, morphine and zofran. F/u 3/17 at Family Practice Clinic and there was no complaint of post-vaccine related events.
63 2021-03-25 loss of consciousness felt like passes out; face turned bright red; sweating; shivering; A spontaneous report was received... Read more
felt like passes out; face turned bright red; sweating; shivering; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, face turned bright red/erythema, sweating/ hyperhidrosis, shivering/shivering, felt like she would pass out/loss of consciousness, blood pressure was 88/66/ hypotension. The patient's medical history was not provided. Concomitant medications reported was valsartan. On 4 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010AZIA) in the left arm intramuscularly for prophylaxis of COVID-19 infection. On 4 Mar 2021, the patient after she received mRNA-1273, she waited for 30 minutes and was okay. She drove about half an hour, and her face turned bright red, sweating, shivering, felt like she would pass out. The event felt like she would pass out was assessed as serious as per IME list. She pulled to the side of the highway to wait, it got worse. She called 911 and they transported her to the hospital. She went to the ER from 2:30 to 5:30pm. They did a lot of tests; blood test, heart test, EKG, everything was normal. They put her on saline bags. When the ambulance first got there her blood pressure was 88/66, when she left the hospital it was back to normal. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events face turned bright red, sweating, shivering, felt like she would pass out/loss of consciousness was not reported whereas event blood pressure was 88/66 was resolved on 4 Mar 2021.; Reporter's Comments: This case concerns a 63-year-old female who had a serious unexpected event of loss of consciousness along with nonserious unexpected hypotension, erythema, hyperhidrosis, and expected chills. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
63 2021-03-25 blood clot blood clots in upper thigh down to foot; swelling of the foot; tingling; clot was burning and hot; A... Read more
blood clots in upper thigh down to foot; swelling of the foot; tingling; clot was burning and hot; A spontaneous report was received from a consumer concerning a 62-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events blood clots in upper thigh down to foot, swelling of the foot, tingling, and clot was burning and hot. The patient's medical history included insertion of a blood clot filter. Concomitant medications reported were Xarelto for drug use for unknown indication. She is also taking 17 other medications (not provided) and has other medical issues (not provided). She also has a blood clot filter inside her body (location not provided). She also wears compression and diabetic socks. On 25 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: L014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) blood clots in upper thigh down to foot, swelling of the foot, tingling, clot was burning and hot. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), blood clots in upper thigh down to foot, swelling of the foot, tingling, clot was burning and hot was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
63 2021-03-28 chest discomfort, hypertension, heart rate increased She got the vaccine and within 15 minutes she broke into hives, her BP went very high, her pulse wen... Read more
She got the vaccine and within 15 minutes she broke into hives, her BP went very high, her pulse went high and she got the shakes. She was still there while she was there, the event people gave her Benadryl, Sulfasalazine and something else and they called the ambulance. They took her to the hospital, they gave her some oxygen as her chest was tight, and didn't do much more than what they did in the ambulance. They observed her for an hour or so and then let her go home. Once she got home she was very tired and a little dizzy after receiving the medications and stayed at home and didn't do anything. The next day she was fine, her arm wasn't sore, red or anything. Her neck and face were a little red from the rash, but otherwise she was doing good. The hives lasted for 2-3 days, and took some regular Benadryl for a couple of days.
63 2021-03-28 chest discomfort Head and chest swelled due to arthritis in these areas. Had trouble breathing until I took a puff of... Read more
Head and chest swelled due to arthritis in these areas. Had trouble breathing until I took a puff of inhaler. Also took an arthritis tylenol when I got home and that helped relieve my tight chest from arthritis. The next day my head hurt all over and arthritis tylenol helped but I also iced my head and slept most of the day. The second day after I was much better but I needed tylenol for my aching arms and legs.
63 2021-03-28 loss of consciousness Approximately 8-10 minutes after receiving the vaccine, another recipient of the vaccine said that a... Read more
Approximately 8-10 minutes after receiving the vaccine, another recipient of the vaccine said that a woman in the observation area felt like she was going to pass out. Ten seconds later, her husband said that she felt like she was going to pass out. Upon getting to the patient, I felt for a pulse and observed mild breathing. The patient was unconscious and did not awaken with a sternum rub. The patient's husband helped me lower her to the ground, and I administered one dose of Epipen to the patient's lateral left thigh. She awakened and was able to state where she was, the year, and the president. EMT arrived later, and the patient refused further medical treatment.
63 2021-03-29 heart rate increased Started shaking badly and my heart was beating very fast and strong a few minutes after vaccine inj... Read more
Started shaking badly and my heart was beating very fast and strong a few minutes after vaccine injected. Paramedic stayed with me until heart stopped beating so fast, shaking slowed down some. Slight shaking continue for at least an hour.
63 2021-03-29 blood clot Very hard to breath for few minutes; Swollen arm; Nausea; Headaches; Blood clogging; A spontaneous r... Read more
Very hard to breath for few minutes; Swollen arm; Nausea; Headaches; Blood clogging; A spontaneous report was received from a consumer concerning a 63 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events very hard to breath for few minutes/dyspnoea, blood clogging/thrombosis, headaches, nausea, swollen arm/peripheral swelling. The patient's medical history included high blood pressure. Concomitant product use was not provided by the reporter. On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot: 027L20A) for prophylaxis of COVID-19 infection. On 08 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (lot: 0101M20A) for prophylaxis of COVID-19 infection. The first dose of vaccine was taken in non dominant arm and second dose was taken in right dominant arm. On an unknown date, the patient experienced swollen arm. In between the two doses she felt very hard to breath for few minutes and when she took a deep breath it was fine. She had tylenol for the headaches after the second dose on 08 February 2021. She also had nausea along with headaches. She had blood clogging when she was in a blood donation camp. The event very hard to breath for few minutes and blood clogging were considered as medically significant. Thiamine was provided as medication The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. Follow-up received on 17 Mar 2021 included updated date for first dose of vaccine, and the events very hard to breath for few minutes/dyspnoea, blood clogging/thrombosis.; Reporter's Comments: Based on the current available information which shows a strong temporal association between the use of the mRNA-1273 and the reported events and excluding all other etiology, a causal relationship cannot be excluded. Nausea and headache are consistent with the safety profile of the product
63 2021-03-30 chest discomfort dizziness, flushing, swelling of tongue and lips tightness in chest, Face and arms turned red, nause... Read more
dizziness, flushing, swelling of tongue and lips tightness in chest, Face and arms turned red, nausea all within 30 minute observation period. All symptoms were completely relieved within 15 minutes after IM Diphenhydramine 50mg/ml given in the office. Patient refused to go to ER to be evaluated.
63 2021-03-30 fainting, blood pressure increased Within about 10 min of receiving the vaccine, pt reported not feeling well and had syncopal episode ... Read more
Within about 10 min of receiving the vaccine, pt reported not feeling well and had syncopal episode while seated. BP elevated to 230's/100's and pt reported severe headache unlike any she had ever had before. Pt recovered and vital signs normalized. About 10 min later, pt had second syncopal episode. Upon awaking, pt reported severe headache and tingling to extremities. EMS called due to multiple syncopal episodes. EMS assessed and did not feel that transport to ED was necessary and left. Approximately 7 min after they left, pt had two more syncopal episodes, each accompanied by BP >200 systolic, severe headache and tingling to extremeties. EMS called again and pt transported to ED. Pt was observed in ED. Pt reports to ED provider total of 6 syncopal episodes. Per ED notes, no further syncopal episodes in ED and pt returned to baseline. ED physician did not feel that this was anaphylactic reaction to vaccine. Pt discharged to home.
63 2021-03-30 blood clot pain in left arm, numbness. Then developed a itchy rash and a lump in the cubital fossa and swollen ... Read more
pain in left arm, numbness. Then developed a itchy rash and a lump in the cubital fossa and swollen lymph nodes. Initially took benadryl, then went to the ED. An ultra sound showed a clot located in her left cubital fossa. Transferred to Med center started on eliquis and released from the hospital. Now complaining of pain in the left leg. Adv caller to follow up with her pcp about the pain.
63 2021-03-31 blood pressure increased Approximately 5 minutes after vaccination, the patient c/o "swelling in my mouth". She was reclined... Read more
Approximately 5 minutes after vaccination, the patient c/o "swelling in my mouth". She was reclined and vital signs taken: BP 180/120, P 97, R 18, O2 Sat: 97%. She also c/o blurry vision. EMS was called and 50 mg Benadryl was given IM in the Right Deltoid. She was able to swallow small sips of water. Approx. 5 minutes later, she stated that she could feel the swelling receding in her mouth. EMS arrived and she was feeling better, but her BP remained elevated at 180/120 and she was transported to Medical Center via EMS for elevated BP. The patient called us this morning 4/1/2021 to report that she is home. She was treated at the hospital for elevated BP and sent home when BP returned to normal.
63 2021-03-31 heart flutter Glare headache; Heart flutters; Severe pain in both shoulders; Fever 102.2; Right arm injection was ... Read more
Glare headache; Heart flutters; Severe pain in both shoulders; Fever 102.2; Right arm injection was itchy; Right arm injection site was sore; Diarrhea; A spontaneous case was received from a consumer concerning a 63-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed pain at vaccination site itching headache ,pain at both the shoulders ,pyrexia, heart flutters and diarrhea. . The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event was not reported. On 11 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 12 Feb 2021,she experienced her arm was sore and itchy at the injection site. On 12 Feb2021 she developed a 102.2 fever and severe pain in both shoulders. On 13 Feb 2021, patient experienced diarrhea and heart flutters. On 14 Feb,2021 she experienced a glare headache. Treatment for the event included ,Tylenol. Action taken with mRNA-1273 in response to the event, unknown. The outcome of the event, pain at vaccination site, itching headache ,pain at both the shoulders ,pyrexia, heart flutters and diarrhea., was considered unknown.; Reporter's Comments: This case concerns a 63 Y/O F with a serious unexpected event of cardiac flutter, and non serious unexpected diarrhea, severe arthralgia and expected pyrexia, headache, vaccination site pruritus, and vaccination site pain. Event onset the same day as first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
63 2021-03-31 chest discomfort Tingling in hands and fingers; Alternating sweats and cold; Sweating; Hypothermic 93 F; Functioning ... Read more
Tingling in hands and fingers; Alternating sweats and cold; Sweating; Hypothermic 93 F; Functioning slow; Chest felt heavy; Flu-like symptoms; Weakness; felt like i couldnt move; Chills; Arm pain; Fever; Nauseous; Fatigue; A spontaneous report was received from consumer concerning a 63-year old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain, nausea, fever, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms, hypothermic, alternating sweats and cold, tingling in hands and fingers, functioning slow. The consumer's medical history was not provided. No relevant concomitant medications were reported. The patient received their first dose of mRNA-1273 (batch number: 025J20A) on an unknown date. On 2 Feb 2021, prior to the onset of the events the consumer received second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection. On 3 Feb 2021, the consumer experienced the events arm pain, nauseous, fever, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms. On 4 Feb 2021, the patient experienced the events hypothermic 93 f, alternating sweats and cold, tingling in hands and fingers, functioning slow. The event hypothermic 93 F was considered medically significant. Treatment details included paracetamol and ibuprofen to relieve symptoms. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events, fever and alternating sweating and cold, was considered recovered/ resolved on 04 Feb 2021. The outcome of the events, arm pain, nausea, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms, tingling in hands and fingers, functioning slow, were unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
63 2021-03-31 nosebleed nose bleed several time four or five days after vaccine. in last 15 days nose bleeds total 7-8 time ... Read more
nose bleed several time four or five days after vaccine. in last 15 days nose bleeds total 7-8 time no treatment at this time , was directed to report to gov
63 2021-03-31 low blood oxigenation, chest discomfort lack of oxygen; numb left hand; heaviness of head and back; very high pressure in the chest; circula... Read more
lack of oxygen; numb left hand; heaviness of head and back; very high pressure in the chest; circulatory issues in the legs with varices; sinusitis; has lymph nodes in the neck , such a big ball t; weakness; joint and muscle pains; joint and muscle pains; feeling tired; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following event: numb left hand, joint and muscle pains (arthralgia), feeling tired (fatigue), weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis. The patient's medical history was not provided. No relevant concomitant medications were reported. On 24-FEB-2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection. On 24-FEB-2021, the patient experienced the event(s) numb left hand, joint and muscle pains, feeling tired, weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis. Treatment details included antibiotics. Action taken with mRNA-1273 in response to the events is unknown. The outcome of event(s), numb left hand, joint and muscle pains, feeling tired, weakness, has lymph nodes in the neck , such a big ball that did not go away and lasted almost 2 weeks, heaviness of head and back, lack of oxygen, very high pressure in the chest, high range of beats per minute (84), circulatory issues in the legs with varices, sinusitis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
63 2021-03-31 palpitations, chest discomfort customer went out to her vehicle and started experiencing heart palpitations and feeling dizzy and l... Read more
customer went out to her vehicle and started experiencing heart palpitations and feeling dizzy and lightheaded. customer had shortness of breath and started feeling tightness in throat and chest. customer drove home and had flu like symptoms the rest of the evening. She began having shooting pains and her sciatica was acting up and she was unable to sleep. felt better in the morning, but not at all 100%.
63 2021-04-01 blood pressure decreased, hypertension, blood pressure increased Patient started losing her voice and having to clear her throat. Had history of anaphylaxis reaction... Read more
Patient started losing her voice and having to clear her throat. Had history of anaphylaxis reactions to other medications in past. The reaction started happening approximately 5 minutes after vaccine given. Patient was given Benadryl 50mg IM in R arm. Vital signs were taken and noted to be stable except high blood pressure. Vital signs taken again after 5 minutes and remained stable with only slight decrease in BP. After approximately 10minutes patient had stopped clearing throat and her voice had returned and she was back to her baseline health. Was told to go to Emergency Room for elevated BP.
63 2021-04-01 blood pressure increased, heart rate increased Patient was administered first dose of COVID19 (Moderna) vaccine. Within 5 minutes of administration... Read more
Patient was administered first dose of COVID19 (Moderna) vaccine. Within 5 minutes of administration, patient complained of feeling faint, dizzy, weak. She stated her heart was pounding very fast and it felt like it was going to come out of her chest. Patient also complained of headache and stated she felt very nervous. Blood pressure was taken and patient had it elevated (171/96). Pharmacist was with patient until paramedics arrived. Paramedics measured patient's oxygen level, took her pulse, took her blood pressure and monitored her heart. Patient declined to be taken to the hospital.
63 2021-04-01 chest discomfort Severe itching on vaccinated are, chest , stomach and back. Rashes and hives, Burning skin, Sneezing... Read more
Severe itching on vaccinated are, chest , stomach and back. Rashes and hives, Burning skin, Sneezing, over active sinuses, Nausea, swelling in neck glands and ear glands, facial swelling at mouth and eyes, tightness in chest and difficulty breathing. The symptoms got worse each day and I went to Urgent Care on the 6 th day when the swelling started. I was given a Steroid shot and a prescription for Predizone for 10 days. The shot helped within a hour or two but the symptoms are still there but not as severe. All these symptoms have happened to me before when I have accidentally injested Gluten or Wheat. Is there Wheat in the fillers? I am very nervous about having the 2nd shot !!!!!!!
63 2021-04-02 chest discomfort, hypertension, chest pain Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heav... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium
63 2021-04-02 chest pain, palpitations Redness at shot spot, with minor itchiness lasting 11 days so far Increase in chest pain and palpita... Read more
Redness at shot spot, with minor itchiness lasting 11 days so far Increase in chest pain and palpitations also lasting 11 days so far
63 2021-04-03 loss of consciousness, heart rate decreased At 11:32 patient start to feel hot and clammy. Upon assessment patient began to slowly become unable... Read more
At 11:32 patient start to feel hot and clammy. Upon assessment patient began to slowly become unable to speak while seemingly losing consciousness. Patient's pulse began to drop. She was administered epinephrine 0.3mg at 11:33am in the right thigh and given a cold compress over forehead. Within the following minute patient could sit up and became alert. Blood pressure was checked at 11:40 and was 112/66 with pulse of 55. She was now able to speak and state her name, where she was, etc. Ambulance arrived and completed assessment. Patient refused transport to hospital and was able to walk out of the pharmacy. She called a couple of hours later and stated that she was feeling much better and back to herself.
63 2021-04-04 lightheadedness, chest discomfort went into seizure; felt a metallic taste; felt dizzy; nearly fainted; not able to walk; had chest ti... Read more
went into seizure; felt a metallic taste; felt dizzy; nearly fainted; not able to walk; had chest tightness; did not feel like she could breathe; did not feel well; her face was flushed like she was on fire; A Spontaneous report was received from a physcian concerning a 63 Year old Female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Dysgeusia/Felt like metallic taste, Dizziness/Dizzy, Presyncope/ Near fainting, Gait Disturbance /Walking difficulty, Chest discomfort/ Chest tightness, Dyspnoea/ Breathing difficult, Malaise/ Feeling unwell, Seizure, Blood pressure abnormal, Blood sugar abnormal and Flushing. The patient's medical history included Asthma. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination. On 9 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via intramuscular route and unknown location for prophylaxis of COVID-19 infection. had chest tightness and she is an asthma patient. She did not feel like she could breathe and did not feel well. She went back to the pharmacy and they did not want to give her EpiPen. She went into seizure because she already had seizure disorder. Her blood pressure went to 162/80 and her blood sugar went to 152 when she was on her way to the hospital and her face was flushed like she was on fire. She took Zofran during her 5 hours of hospitalization and got a CT scan. They diagnosed her with a post vaccination reaction but she still wants to get the second dose. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the event Dysgeusia, Dizziness, Presyncope, Walking difficulty, Chest discomforts, Dyspnoea, Malaise, Seizure, Blood pressure abnormal, Blood sugar abnormal and Flushing was considered unknown.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the events, and excluding other etiologies but for history of asthma, causal relationship cannot be excluded.
63 2021-04-05 blood pressure fluctuation, heart rate irregular Immediate metallic taste within seconds of the injection and the taste stayed for a month. Notified ... Read more
Immediate metallic taste within seconds of the injection and the taste stayed for a month. Notified the nurse and they did not aware of this and asked her questions and observed her and she was allowed to leave. By the time she was at the lobby she you felt tingling in lips, difficulty swallowing, tongue swelled and turned black and throat was closing. She drove to the ER and they gave her an EpiPen and fluids and kept her for observation. An hour later she had severe chills and was offered 5 warm blankets and erratic heart rate and blood pressure fluctuation. In hospital for 6 hrs.
63 2021-04-05 chest discomfort, very slow heart rate, palpitations, heart rate increased, sinus rhythm Rec'd injection on 3/19/2021 in the afternoon. By that night, patient reports she started to run fev... Read more
Rec'd injection on 3/19/2021 in the afternoon. By that night, patient reports she started to run fever and had a sore arm. Reports she also developed a rash from the injection site that went up to her shoulder. Reports rash was very warm to touch and "splotchy" looking and very red. Prior to injection she was having issues with bradycardia. After injection she began to have palpitations and her heart rate increased with noted chest discomfort and dyspnea on exertion.
63 2021-04-05 chest pain pt states that she had chest and back pain. She had nausea, fever, and pain her her jaw and pain in... Read more
pt states that she had chest and back pain. She had nausea, fever, and pain her her jaw and pain in her upper stomach. She thought she was having a heart attack so she went to ER, . She was given an EKG and given nitroglycerin. She had a GI cocktail. She had a CT scan w/ and w/out contract of her chest and her abdomen. The did Chest X-ray, another EKG, checked Troponin levels and blood test. All test were negative of having a heart attack. Pt was released to go home and relax but call 911 if she had any more chest pains and to FU w Cardiologist if needed. Pt has since recovered from all of these symptoms.
63 2021-04-05 palpitations, blood pressure increased Blood pressure went up and kept escalating. It started at 132/(forgot) right after shot, which is al... Read more
Blood pressure went up and kept escalating. It started at 132/(forgot) right after shot, which is already high for me. I had a doctor's appointment right after the vaccine, so I went to that. By the time they took my BP there, it was 145/80something. Heart was racing. The doctor was concerned and sent me to the ER, where I had a battery of tests. BP peaked at 159/89 in ER. Pulse remained in the 70s.
63 2021-04-05 inflammation of the pericardium, atrial fibrillation See patient's account of the event below. Patient is not an established patient and did not receive ... Read more
See patient's account of the event below. Patient is not an established patient and did not receive care for her symptoms at our facility: On March 18th I received my 2nd Moderna vaccination. On Friday the 19th at approximately 4 pm I began to have the symptoms of an immune response in my body. Sat the 20th was spent in bed with chills, body aches, fever, stiff neck, and bad headache. On Sunday I was having pain on inhalation along with everything else. Monday the pain resolved into left side lung pain on inhalation. Tuesday the 23rd I called my provider who directed me to go to the Emergency Dept. I drove to Superior Hospital. After being accessed I was transported; with pericarditis and the additional mentioned immune response symptoms, and a pronounced heart murmur. On Wednesday the 24 I shook uncontrollably with chills for 4 hours and 2 min and went into atrial fib for about 12 minutes, resolved with medication. Thursday the 25th I woke to all symptoms being gone. I was released on Friday the 26th with the statement my issues had resolved themselves. I was told to report this to where I got my vaccine so it could be passed along.
63 2021-04-06 blood pressure increased Immediate popping in the ears approx. 15 minutes after injection, then brain fog with fatigue. .. Th... Read more
Immediate popping in the ears approx. 15 minutes after injection, then brain fog with fatigue. .. Then the next day fatigue was increased and had to get in bed. Also had a fullness in the ears. Then 2 days later there was headache, neck ache, nausea and vomiting. Unable to take anything by mouth. Heightened sensitivity to light and smells. Went to hospital on the 3rd day and was admitted. Blood pressure was extremely elevated at that time. Discharged 3 days later. Presently has dull ache in both ears and hears an echo. Hearing is slightly decreased. Affecting balance at present.
63 2021-04-06 fainting I had a horrible, lengthy Charley Horse cramp (on my right leg), followed by stomach pains, dizzines... Read more
I had a horrible, lengthy Charley Horse cramp (on my right leg), followed by stomach pains, dizziness, diarrhea, fever, sweats, blurry vision, nausea, then I fainted/collapsed. When I came to, I was disoriented, had more diarrhea, chills, followed by my second Charley Horse cramp, this time on my left leg. When I woke after a few hours of sleep, I was tired, weak and had a slight headache but generally felt ok. By Tuesday, other than little/mild muscle aches, I'm back to normal.
63 2021-04-06 fainting I had the second dose of Moderna at 11:30 a.m. on April 5, 2021. By 8:30 p.m. on April 5, 2021, I ... Read more
I had the second dose of Moderna at 11:30 a.m. on April 5, 2021. By 8:30 p.m. on April 5, 2021, I was running a temperature and had chills for hours. At around 2 am., I got up, fainted and fell. Had a blow to my head. Fainted a second time and fell. Went to the ER with a 101 temperature. I was admitted to ICU. The CT scan didn't show any brain bleeding. Hurt my lower back when I fell.
63 2021-04-07 hypotension, fainting Immediately after receiving the 1st dose I had a bad reaction, I started getting dizzy and weak, swe... Read more
Immediately after receiving the 1st dose I had a bad reaction, I started getting dizzy and weak, sweating, shaking, blurred vision and low blood pressure, and I fainted. I never had that before and it took me an hour before I could get up and walk.
63 2021-04-07 palpitations, chest pain Heart palpitations the evening of my injection and heart palpitations and chest pain the second day ... Read more
Heart palpitations the evening of my injection and heart palpitations and chest pain the second day of my injection. Day 3 and after no symptoms
63 2021-04-08 chest discomfort Patient described feeling weak and out of breath (heavy feeling in chest) on Wednesday, April 7, 202... Read more
Patient described feeling weak and out of breath (heavy feeling in chest) on Wednesday, April 7, 2021. On the morning of 4/8/2021, patient noticed a small nodule on right elbow (has a sore appearance to it). As the morning continued, she noticed raised red/purple bruising on right anterior forearm. When she presented to the pharmacy, she also had what appeared to be erythema spreading to posterior right forearm. She describes the "rash" as being itchy.
63 2021-04-09 fainting Syncopal episode
63 2021-04-09 fast heart rate, chest pain, hypertension Chest pain High blood pressure (200/140 mmhg Tachycardia Dypsnea
63 2021-04-10 heart rate increased, hypertension I experienced hip joint and leg pain on my left side at night typically commencing three hours into ... Read more
I experienced hip joint and leg pain on my left side at night typically commencing three hours into sleep cycle. In the first week after the vaccine, the pain was quite sharp and severe in my left hip. Over time the pain spread further down my leg and was a searing ache. I did not experience leg or joint pain when awake and up and around. About four days I awoke having what seemed like one of my sleep cycle panic attacks with the exception that I did not experience mental panic, only very rapid heart beat and high blood pressure and arm tingling. I took alprazolam as prescribed by my physician. The symptoms were very slow to abate. I was concerned I was having a stroke or heart attack but decided it was just a panic attack. By week four following my first vaccine the leg pain had lessened. After the second vaccine, the entire scenario above reoccured including hip and leg pain on my left side. The pain in my joint was not as sharp but it is severe enough to wake me up. It occurs at about 3:30 am at night and lasts 2-3 hours. I had a second panic attack with the same description of symptoms (severe rapid heart beat (153) high blood pressure (can provide exact measure - I recall the upper number was 165 and I typically have normal blood pressure). Took alpralozam and the cardiac synptoms were slow to abate and in fact resurged even after medication. I continue to have left-side hip and knee join pain and leg pain in my sleep to this day on the same very regular, predictable schedule and the pain continues to be enough to wake me up and make me very uncomfortable, thereby disrupting my sleep every night. I have had no further "panic" attacks. At this time, my left side joint and leg pain is somewhat noticeable during the day but I do not have mobility issues. Am able to walk, exercise etc. normally.
63 2021-04-10 palpitations Starting 2 days after shot heart palpitations at random times of the day and that went on for two we... Read more
Starting 2 days after shot heart palpitations at random times of the day and that went on for two weeks. They became worse during sleeping hours so I was awake a lot of the night. Episodes of vertigo with shortness of breath when walking or rising from sleeping. Still suffering from daily headaches.
63 2021-04-12 chest pain, deep vein blood clot I ended up with DVT blood clot. Injection was very painful and pain lasted 2 days, expected that. Da... Read more
I ended up with DVT blood clot. Injection was very painful and pain lasted 2 days, expected that. Day 3 woke with bright red rash, itchy, swollen and lumpy on inside upper arm. Could not get answers, lived on Benydril for 3 days. Day 4 called CDC, FDA, Health Dept & Moderna. Moderna was only person that I was able to talk to someone, had no clue. Had to google to find out I had Covid Arm since no one knew anything. Day 5 ..The lump moved or maybe different one to inside my inner elbow and was painful. Did not read pain as a symptom of Covid Arm and went to ER
63 2021-04-12 deep vein blood clot I had a discoloration on my left breast and slight pain underneath my left arm. I had NO redness, N... Read more
I had a discoloration on my left breast and slight pain underneath my left arm. I had NO redness, NO swelling and NO heat underneath my arm. I had a mammogram and the radiologist asked for an ultrasound. The ultrasound revealed a deep vein thrombosis underneath my left arm.
63 2021-04-12 hypertension Tightness in throat, headache, dizziness, numb in arm, tingling in throat. BP 145/76, HR 84. Recover... Read more
Tightness in throat, headache, dizziness, numb in arm, tingling in throat. BP 145/76, HR 84. Recovered and released in stable condition
63 2021-04-12 blood clot, oxygen saturation decreased, pulmonary embolism blood clots in left leg and both lungs diagnosed on 2/22, died 2/24
63 2021-04-13 blood pressure increased - Nauseous -sat by garage door to get air.- Patient claims, "she always gets nauseous and its not r... Read more
- Nauseous -sat by garage door to get air.- Patient claims, "she always gets nauseous and its not related to the vaccine" Patient stated she has severe ptsd and anxiety. BP 176/98; HR 91; RR 18; 02sat 98%- second time BP190/99 and HR 90??..nausea improved but BP Elevated?.increased anxiety. patient declined ems
63 2021-04-13 heart attack, chest pain, chest discomfort may have had a heart attack; pressure in her chestuncomfortable feeling which lasted for a week; 6 s... Read more
may have had a heart attack; pressure in her chestuncomfortable feeling which lasted for a week; 6 short chest pains that felt like something was moving in her chest; felt really bad; tired/worn out; chills; a fever all night; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (may have had a heart attack) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). Concomitant products included LEVOTHYROXINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced FEELING ABNORMAL (felt really bad), FATIGUE (tired/worn out), CHILLS (chills) and PYREXIA (a fever all night). On 08-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (may have had a heart attack) (seriousness criterion medically significant), CHEST DISCOMFORT (pressure in her chestuncomfortable feeling which lasted for a week) and CHEST PAIN (6 short chest pains that felt like something was moving in her chest). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) from 08-Mar-2021 to 13-Mar-2021 for Heart attack, at a dose of UNK UNK, bid. On 11-Mar-2021, MYOCARDIAL INFARCTION (may have had a heart attack), CHEST DISCOMFORT (pressure in her chestuncomfortable feeling which lasted for a week), FEELING ABNORMAL (felt really bad), FATIGUE (tired/worn out), CHILLS (chills), PYREXIA (a fever all night) and CHEST PAIN (6 short chest pains that felt like something was moving in her chest) had resolved. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
63 2021-04-13 pallor, cardio-respiratory arrest After patient received vaccine she was accompanied by RN to observation area. In observation area pa... Read more
After patient received vaccine she was accompanied by RN to observation area. In observation area patient was sitting in the chair with her head against the wall. RN asked patient if she was alright, patient stated, "she was not well". She was noted to be pale, glassy eyed. RN called for immediate assisatance. Pt was transferred with assitance to recliner. Patit responded to verbal commands, leaned back with feet elevated. Within Vitals 4 minutes were B/P 118/82, HR 99, Spo2 99% on room air, patient noted to be responsive. Patient stated she thinks she was having a panic attack. Vitals were taken B/P 56/40, unable to get reading for heart rate or pulse ox. Code called, Pt was transferred to ED, patient responsive.
63 2021-04-13 pallor, hypotension Nauseas Palor skin Dizzinest Hypotension (90/80 mmHg)
63 2021-04-13 palpitations, loss of consciousness shortly after as she was driving home she felt like she was going to black out had to stop the car; ... Read more
shortly after as she was driving home she felt like she was going to black out had to stop the car; had heart palpitations; was sick for about 5 days; shortly after as she was driving home she felt like she was going to black out had to stop the car and began to vomit; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (shortly after as she was driving home she felt like she was going to black out had to stop the car) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Sinus infection. Concurrent medical conditions included Inner ear disorder. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (shortly after as she was driving home she felt like she was going to black out had to stop the car) (seriousness criterion medically significant), PALPITATIONS (had heart palpitations), ILLNESS (was sick for about 5 days) and VOMITING (shortly after as she was driving home she felt like she was going to black out had to stop the car and began to vomit). On 24-Feb-2021, LOSS OF CONSCIOUSNESS (shortly after as she was driving home she felt like she was going to black out had to stop the car) and VOMITING (shortly after as she was driving home she felt like she was going to black out had to stop the car and began to vomit) had resolved. On 01-Mar-2021, ILLNESS (was sick for about 5 days) had resolved. At the time of the report, PALPITATIONS (had heart palpitations) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date. No concomitant medications were reported.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. Vomiting is consistent to the known safety profile of mRNA-1273.
63 2021-04-13 fainting Patient woke up with fever( temperature unknown) , nausea when waking up she proceeded to do daily a... Read more
Patient woke up with fever( temperature unknown) , nausea when waking up she proceeded to do daily activities, felt light headed which caused her to faint.
63 2021-04-13 fast heart rate While patient was waiting in observation after the vaccination, she complaint of having rash in the ... Read more
While patient was waiting in observation after the vaccination, she complaint of having rash in the arm and that her body and throat were itching. She did not have Benadryl on her, that is why they injected Diphenhydramine 50mg from an emergency car since the itching on the throat gave her coughing and difficulty breathing. Patient also inhaled two pumps of Albuterol HFA. After two minutes of receiving Diphenhydramine, the itching and coughing alleviated.
63 2021-04-13 blood clot, pulmonary embolism burning sensation in the lung; had labored breathing,they found several clots in right leg and lungs... Read more
burning sensation in the lung; had labored breathing,they found several clots in right leg and lungs; It was shiny and hard and calf blewup twice the size,they found several clots in right leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (had labored breathing,they found several clots in right leg and lungs) and THROMBOSIS (It was shiny and hard and calf blewup twice the size,they found several clots in right leg) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Family history included Clot blood (Family history of clots; her father and his sister had clots after surgery). Concurrent medical conditions included Burning sensation. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PULMONARY EMBOLISM (had labored breathing,they found several clots in right leg and lungs) (seriousness criterion medically significant) and THROMBOSIS (It was shiny and hard and calf blewup twice the size,they found several clots in right leg) (seriousness criterion medically significant). On an unknown date, the patient experienced BURNING SENSATION (burning sensation in the lung). At the time of the report, PULMONARY EMBOLISM (had labored breathing,they found several clots in right leg and lungs), THROMBOSIS (It was shiny and hard and calf blewup twice the size,they found several clots in right leg) and BURNING SENSATION (burning sensation in the lung) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound Doppler: several clots in right leg and lungs (abnormal) several clots in right leg and lungs. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products were reported. Patient was taken to the ER (emergency room). The physician suspected blood clots and treatment included was blood thinner. Patient reported that "patient got ultrasound done on Monday, and they found several clots in right leg and lungs".; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded
63 2021-04-14 palpitations, heart rate increased AT time of injection felt warm feeling go up her neck and down her arm when vaccine was administered... Read more
AT time of injection felt warm feeling go up her neck and down her arm when vaccine was administered. Within 5-10 minutes of the vaccine felt palpitations. Then summoned help. Nursing staff monitored her, Heart rate up to 135. Denied c/o chest pain or SOB. Pulse oximitry =98%. The palpitations subsided within 15-20 minutes. Later that evening at home her raced again and took her own pulse =110.
63 2021-04-15 atrial fibrillation atrial fibrillation; achy; hand pain; This spontaneous case was reported by a consumer and describes... Read more
atrial fibrillation; achy; hand pain; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Atrial fibrillation. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant), MYALGIA (achy) and PAIN IN EXTREMITY (hand pain). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), MYALGIA (achy) and PAIN IN EXTREMITY (hand pain) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Although the patient has history of atrial fibrillation, based on a strong temporal association, a causal relationship between the administration of and the event s reported cannot be excluded.; Sender's Comments: Although the patient has history of atrial fibrillation, based on a strong temporal association, a causal relationship between the administration of and the event s reported cannot be excluded.
63 2021-04-15 arrhythmia, atrial fibrillation hospitalized for COVID19 related PNA as well as new onset Afib/flutter
63 2021-04-15 excessive bleeding 8 hours after shot severe headache that started in back of neck, freezing cold, shaking and shiverin... Read more
8 hours after shot severe headache that started in back of neck, freezing cold, shaking and shivering uncontrollably. Back ache. Shakes and shivers lasted 4 hours. Headache and back ache lasted 48 hours. Severe fatigue for first 24 hours, last 24 hours moderate fatigue. After 48 hours, I was back to 100% health. I took aspirin to begin with for the headache, then switched to ibuprofen when aspirin didn?t work for headache. Ibuprofen helped back ache immensely. Also, when pharmacist gave me the 2nd shot when I got home and changed clothes I realized I had bled a lot. Blood had oozed out from the bandage and down to my elbow. Arm sore for 2 days, and still swollen on 4th day a bit larger than golf ball size.
63 2021-04-15 hypertension PT. HAD NAUSEA, VOMITING AND FELT LIKE HAD HIGH BLOOD PRESSURE AND ALSO DIZZINESS
63 2021-04-15 hypotension, loss of consciousness brief loss of consciousness; low blood pressure; blurry vision; dizziness; shakiness; cold chills; n... Read more
brief loss of consciousness; low blood pressure; blurry vision; dizziness; shakiness; cold chills; nausea; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (brief loss of consciousness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (Medical history not provided.). On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (brief loss of consciousness) (seriousness criterion medically significant), HYPOTENSION (low blood pressure), VISION BLURRED (blurry vision), DIZZINESS (dizziness), TREMOR (shakiness), CHILLS (cold chills), NAUSEA (nausea), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). On 24-Mar-2021, LOSS OF CONSCIOUSNESS (brief loss of consciousness) had resolved. At the time of the report, HYPOTENSION (low blood pressure), VISION BLURRED (blurry vision), DIZZINESS (dizziness), TREMOR (shakiness), CHILLS (cold chills), NAUSEA (nausea), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not reported. No treatment was taken. Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
63 2021-04-15 fast heart rate redness local reaction, tachycardia
63 2021-04-16 excessive bleeding Herpes in genital area. This spot is where i generally have a herpes outbreak, but it was different ... Read more
Herpes in genital area. This spot is where i generally have a herpes outbreak, but it was different this time. The lesion bleeds. Feels just like other herpes lesions. I am not sexually active, and have not had a herpes outbreak for a long time. When i had the first shot, which was 3/19/21, Moderna through, lot #037A21B, about a week after the first immunization, i developed a rash on my right abdomen, just below the rib cage. It was fine, closely spaced red bumps, very itchy. I thought at first it was chiggers, but the weather is cool and seems in the wrong place for chiggers. It seemed to become tiny blisters, and i started wondering if it was shingles. It stung and hung on for several days, weeping a little blood. but it cleared up quickly. While it was scabbing over, i had a larger blister on my right wrist. It looked almost like a fire ant blister, but again no ants. Felt very itchy, tingly, like the rash below my ribs. Within a day, the blister burst and bled. It took three or four days to heal. I thought these were weird at the time, but did not connect them to the vaccination, until i had the second dose, and my genital herpes blister bled. This is not yellowish pus, it is bright, arterial style blood, thin, but definitely blood.
63 2021-04-16 loss of consciousness Pain at injection site, generalized fatigue, ache ~10 hours post-injection- Chills, leg muscle cra... Read more
Pain at injection site, generalized fatigue, ache ~10 hours post-injection- Chills, leg muscle cramps ~16 hours post-injection Nausea, headache ( passed out for several seconds ) ~19 hours post-injection Completely fine ~42 hours post-injection
63 2021-04-16 pallor Patient stated she experienced paleness for 2 weeks, was extremely lethargic, a period of time she ... Read more
Patient stated she experienced paleness for 2 weeks, was extremely lethargic, a period of time she felt as though she were paralyzed for 1 hour when she could not move her arms and legs, and her legs felt extremely weighted throughout the 2 week period after receiving the vaccine.
63 2021-04-16 palpitations, blood pressure increased PALPATATIONS, FELT FLUSH WITHIN 13 MINS OF RECIEVING. BLOOD PRESSURE ELEVATED FOR THIS PATIENT, CAM... Read more
PALPATATIONS, FELT FLUSH WITHIN 13 MINS OF RECIEVING. BLOOD PRESSURE ELEVATED FOR THIS PATIENT, CAME BACK DOWN TO NORMAL FOR HER WITHIN 15 MINS
63 2021-04-16 palpitations, fast heart rate tachycardia/heart palpitations . Patient recovered. Cleared by EMS
63 2021-04-17 enlargement of the heart, heart failure Pt was in her usual state of health. Denied any past hx heart problems, works full time past medical... Read more
Pt was in her usual state of health. Denied any past hx heart problems, works full time past medical hx sign for dm-2, obesity, htn and crohns disease. lifelong non smoker, no etoh use. received her 2nd covid 19 vaccination on 3/24/2021 then began having progressive sob starting on 3/28/2021. presented to the emergency room on 4/11/2021 with sign sob. cxr showing b/l pulmonary edema. pt admitted to the hospital with new onset heart failure. She ultimately underwent an angiogram which showed minimal non obstructive coronary artery disease after echocardiogram showed severe global hypokinesia and ejection fraction of 15%. She was diagnosed with idiopathic non ischemic cardiomyopathy. CT scan of the chest also showed new medistinal lymphadenopathy.
63 2021-04-17 heart rate increased Hours after the second dose I became dizzy, nauseous, had a racing heartbeat, had severe body aches ... Read more
Hours after the second dose I became dizzy, nauseous, had a racing heartbeat, had severe body aches and headache, and ran a fever of 101. I began throwing up, even water, and this continued for 3 days. As of today, I have a very red and swollen arm, sore and itchy, and am still experiencing nausea, chills, vertigo, and intermittent body aches in my back, hips, knees, shoulders. I also developed diarrhea. My fever ended yesterday. I have also noticed loss of taste and tinnitus. I was so ill on Thursday and Friday that my partner was prepared to take me to the ER if I didn't improve by Saturday. Fortunately, I did begin to feel a bit better on Saturday, but as of this evening I am still far from recovered. I have taken photos of my injected arm daily. Based on my experience with this 2nd dose of Moderna, I will never voluntarily take another COVID-19 vaccine, no matter the manufacturer.
63 2021-04-17 heart rate increased Major flu symptoms. Fingers and toes ached. Headache. Nauseous. Weakness. Felt generally ill all ov... Read more
Major flu symptoms. Fingers and toes ached. Headache. Nauseous. Weakness. Felt generally ill all over, like the flu. Rapid heartbeat. Shortness of breath. No fever. Felt better on 4/18/21.
63 2021-04-17 hypertension Migraine, high blood pressure spike, tinnitus, general fatigue. 24 days later: tinnitus still ongoi... Read more
Migraine, high blood pressure spike, tinnitus, general fatigue. 24 days later: tinnitus still ongoing, extreme fatigue (not able to walk slowly for more than 15 minutes or perform daily tasks), head pressure, ear pressure. Unable to work in computer for more than an hour.
63 2021-04-18 chest pain Nauseated, pounding headache; severe chest pain; trouble breathing; sharp quick repeated pain in my... Read more
Nauseated, pounding headache; severe chest pain; trouble breathing; sharp quick repeated pain in my fingers, wrists, and feet; 100 degree temp; pelvic pain much more severe than I have ever had with Interstitial Cystitis = EIGHT HOURS
63 2021-04-18 heart rate increased, chest pain heart beating fast; chest pain; difficulty of breathing; This spontaneous case was reported by a con... Read more
heart beating fast; chest pain; difficulty of breathing; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart beating fast), CHEST PAIN (chest pain) and DYSPNOEA (difficulty of breathing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation. On 06-Apr-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021 at 5:00 PM, the patient experienced HEART RATE INCREASED (heart beating fast) (seriousness criterion medically significant), CHEST PAIN (chest pain) (seriousness criterion medically significant) and DYSPNOEA (difficulty of breathing) (seriousness criterion medically significant). On 06-Apr-2021, HEART RATE INCREASED (heart beating fast) and DYSPNOEA (difficulty of breathing) had resolved. On 07-Apr-2021, CHEST PAIN (chest pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Electrocardiogram: abnormal (abnormal) She took an electrocardiogram (ECG) with her home cardio machine and reported that her heart was beating extremely bad. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment included for the events were metoprolol 75mg that night, 25mg in the morning of the next day (07 Apr2021) and 50mg that night. The patient reported that she was now feeling fine. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. However, the patient's history of Atrial fibrillation is a risk factor and confounds causality assessment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. However, the patient's history of Atrial fibrillation is a risk factor and confounds causality assessment.
63 2021-04-18 heart rate increased Patient developed muscle weakness, dizziness, wheezing/shortness of breath, rapid heart beat several... Read more
Patient developed muscle weakness, dizziness, wheezing/shortness of breath, rapid heart beat several hours after immunization. Patient has been resting.
63 2021-04-19 skin turning blue 63-year-old woman who presents with severe pain in her left upper extremity. The pain began around ... Read more
63-year-old woman who presents with severe pain in her left upper extremity. The pain began around 2 PM suddenly while she was driving. The pain gradually worsened and she noted cyanosis of her left arm. She developed severe pain and gradually developed weakness in her left hand. She denies history of trauma. She has had no recent fevers chills or night sweats. She denies a history of IV drug abuse or use of any other recreational drugs. She does smoke approximately 1 pack/day. Currently taking estrogen and progesterone. History of Moderna vaccine in the left arm about 2 weeks prior. S/p Left brachial thromboembolectomy due to left brachial artery thrombus. on 3/23/2021. Discharged on aspirin and Lovenox (hypercoag workup pending at discharge). Antiphospholipid antibody panel found to be negative. Has transitioned to Eliquis at this time for recommended 6 months per hematology. Hormone replacement meds stopped.
63 2021-04-19 palpitations Heart palpitations, fever, muscle and joint aches, swollen arm at injection site and large redness a... Read more
Heart palpitations, fever, muscle and joint aches, swollen arm at injection site and large redness at injection site, sore arm at injection site, tiredness, headache.
63 2021-04-19 fainting, loss of consciousness After the patient waited her 15 minutes, she left the pharmacy by driving her vehicle. While in her ... Read more
After the patient waited her 15 minutes, she left the pharmacy by driving her vehicle. While in her vehicle, she was stopped at a stop light and thinks she fainted or blacked out. She woke up in the middle of the intersection and was able to hit the gas before she was hit by another car. She did not go anywhere for treatment and has not experienced the same side effect since that time.
63 2021-04-20 chest discomfort, heart rate increased Heart is beating very fast Heaviness on chest
63 2021-04-20 fast heart rate There were two reactions. Both were the same. I didn't record the first time. They happened about 3 ... Read more
There were two reactions. Both were the same. I didn't record the first time. They happened about 3 days apart. The second came on suddenly. Beginning at 8:24 p.m. Tachycardia 115 b.p.m. Didn't start to slow down for about 30 minutes. One and a half hours later the pulse started to slow to 84 b.p.m. Was well over 2.5 hours until down to about 70 b.p.m. During the entire time my b.p. never went above 110/71. I stayed home and didn't contact my doctor. Days followed everything was normal. Will not be receiving the second shot.
63 2021-04-21 loss of consciousness After first dose on March 22, I was fine. However on March 31, I woke up very nauseous, headache, ... Read more
After first dose on March 22, I was fine. However on March 31, I woke up very nauseous, headache, head felt foggy and cloudy, dizzy. Went to work. At 9am, i got so dizzy when I turned head that I blacked out, hit cheek on chair as I fell to floor. Saw Dr. at the Family Health Clinic, who did EKG, Epply test, blood pressure and recommended going to ER for further evaluation. Cat scan with contrast was done to check for anything unusual. On April 1, was prescribed Meclizine by Dr. to take for dizziness. On April 20- received 2nd dose of vaccine- started to feel headache, slight dizzy by 11:30 that evening. Next morning, felt slight nausea, light headed and dizzy. Started taking meclizine again for dizziness at recommendation of Dr. Spoke with Dr. from Family Health Center again on 4/22/21 to advise of stronger symptoms.
63 2021-04-21 transient ischaemic attack Confusion, slurred speech, ptosis of the right eyelid, lightheadedness, right facial droop and troub... Read more
Confusion, slurred speech, ptosis of the right eyelid, lightheadedness, right facial droop and trouble with memory with associated soreness in right arm post Moderna vaccination second dose for COVID-19 on 23 March 2021. TIA vs vaccine reaction (symptom onset roughly 45 minutes post injection) CT of the head without contrast, CTA head and neck and MRI of brain without contrast, CTA head and neck showed mild beaded appearance of the distal cervical segment of the left vertebral artery consistent with fibromuscular dysplasia. There is no stenosis. MRI brain showed chronic microvascular ischemia DC with Plavix and neurology referral, symptoms resolved
63 2021-04-22 blood pressure increased Patient reported to Pharmacist after 5 minutes after having Moderna Injection she was not feeling w... Read more
Patient reported to Pharmacist after 5 minutes after having Moderna Injection she was not feeling well. She looked very panic I sat with her and she explained she was having numbness in hands and chest . She was not having difficulty breathing so I did not give her an epi pen injection. WE talked and after 5 minutes I asked if she would like a benadryl 50mg injection She said yes because she was not getting better. She was getting very anxious 5 minutes later I asked her if she wanted to call 911 The staff did so . Paramedics arrived in 10 minutes lThey gave her oxygen and started an IV Her blood pressure was elevated . She was taken to nearby hospital . Paramedic stated I did the right thing by calling and that she had been hyperventalating which can cause numbness in chest and hands
63 2021-04-22 chest pain Injection at 9:10am. Ten minutes after injection, severe swelling in left arm. Informed nurse. She s... Read more
Injection at 9:10am. Ten minutes after injection, severe swelling in left arm. Informed nurse. She stated to remove watch band that was cutting into left arm - the swelling was normal. Ten minutes after noticed arm swelling. Pressure on left and front of side of throat with difficulty breathing. Informed nurse. We talked and she suggested I get out of the car walk around and take deep breaths. After doing so I informed nurse my breathing wasn't any better. She took me inside one of the buildings and found someone to use a pulse ox to test blood oxygen level. She said it was fine and I was good to go when 30 minutes was up. Husband drove me home, I laid down for a nap at 2:30 pm and got up at 4:45 pm. I woke several times during nap due to pain in lower left arm and upper left chest. When I got up I had difficulty breathing, talking and walking. I called on nurse. She asked questions and told me to call 911. My husband drove me to hospital in because it was faster than getting an ambulance. On the way to hospital swelling increased to left jaw and left ear. At Hospital I was seen by many nurses, I received 2 Pepcid, a Benadryl shot and a steroid shot. Due to the location of pain they were concerned they were concerned that something was wrong with my heart or I was having a heart attack. They took blood tests and chest xrays and did an EKG. Then they had me wait for a long time then did another EKG because they didn't like the results of first EKG. No changes in EKG's. They prescribed Pepcid 20 mg BID and Prednisone 2 20 mg tablets once a day. RX for Epi-pen 2 pack. Started with medications on Monday 4/12/21 morning and took for 5 days as prescribed. Also called primary care on 4/12/21 to inform them of situation. Also called hospital on 4/12/21 asking how to get records and get information
63 2021-04-22 hypertension Scratchy throat, swollen bottom lip and high BP Note: twitching of bottom lip persisted daily for on... Read more
Scratchy throat, swollen bottom lip and high BP Note: twitching of bottom lip persisted daily for one month then occasionally for second month following vaccine
63 2021-04-22 pallor, fainting Pharmacist administering vaccine (Name). Pharmacist reports the following: Shortly after receiving t... Read more
Pharmacist administering vaccine (Name). Pharmacist reports the following: Shortly after receiving the second dose of her Moderna series, the patient became weak, pale, and began to sweat. The pharmacy technician in the clinic room reported to the pharmacist that the patient appeared to be fainting. The pharmacist went to the patient and asked if she was having trouble breathing. The patient said that she could breathe fine. The pharmacist then sent the pharmacy technician to get the other pharmacist on duty in the pharmacy. The other pharmacist called code white (which alerts the store's security and sets in motion to call emergency authorities). The pharmacist then went to the clinic room and found the patient sitting in a chair and still appeared weak, pale, and sweaty. The pharmacist took the patient's blood pressure which was 104/76. The pharmacist recommended the patient lay on the floor and rest her feet up on the chair. The patient refused and stated she needed to use the bathroom immediately. The pharmacist escorted the patient to the bathroom (with an epipen in labcoat pocket in case the situation escalated further). The patient had a bowel movement and EMS arrived on the scene while the pharmacist and the patient were in the bathroom. EMS checked the patient's vitals and she was stable. The patient did not go to the hospital and was escorted home by her husband.
63 2021-04-22 pallor During COVID clinic on 4/22, patient and husband came to receive their second dose of Moderna. After... Read more
During COVID clinic on 4/22, patient and husband came to receive their second dose of Moderna. After the dose was given, patient was in the waiting area when the administering pharmacist was alerted by pharmacy technician that the patient was feeling weak and like she might pass out. Pharmacist went to the patient and started asking the patient if she was breathing okay. The patient responded yes. Pharmacist told the technician to go to the pharmacy and get the other pharmacist on duty. When other pharmacist was alerted she called a code white and closed the pharmacy so that she could attend to thepatient. When other pharmacist arrived in the clinic room, the patient was sitting in a chair sipping water. Asset protection had already called 911. She was pale and sweating. The other pharmacist took the patient's blood pressure which was 104/76, other pharmacist asked the patient how she felt, she said that she needed to go use the restroom. The other pharmacist told the patient that she would recommend putting her feet up, but the patient said she really just wanted to use the restroom. Pharmacist escorted the patient to the restroom (with an Epipen in coat pocket in case the situation escalated). The patient had a bowel movement and then EMS arrived on the scene. The patient was stable when EMS arrived and was sent home with husband without going to the hospital. No medications were used for patient, she was only given a water bottle and a cool pack.
63 2021-04-23 fluid around the heart, heart attack, atrial fibrillation, palpitations Describe events and outcomes: Abrupt onset of palpitations on the morning of March 22, 2021. Went ... Read more
Describe events and outcomes: Abrupt onset of palpitations on the morning of March 22, 2021. Went to previously scheduled medical appointment where they found my pulse rate to be over 200. ECG was performed and atrial fibrillation was diagnosed. Transported by ambulance to Hospital. Spontaneous conversion during the ambulance transport. Duration of symptoms: approximately 3 hours. Non-ST Elevation MI diagnosed in the hospital. Echocardiogram showed pericardial effusion. Hospitalized 1 day.
63 2021-04-23 fainting Presented to the ER on 4/21/21 with c/o syncope and abdominal pain and nausea and vomiting. pt wasn... Read more
Presented to the ER on 4/21/21 with c/o syncope and abdominal pain and nausea and vomiting. pt wasn't feeling good earlier in the day and became unresponsive falling back onto her bed and son called 911. she arrived in hemorrhagic shock, abd imaging showed a large splenic subcapsular hematoma of unclear etiology (no hx of trauma) with hemoperitoneum and was transferred to a higher level of care for IR .intervention for embolization. She ultimately required splenectomy and mx units of blood. (did get embolization but progressed to further bleeding) and ultimately needed splenectomy 4/24. She is sp 7 units prbc total, 2ffp, 1 plt, 1 cryo.She remains hospitalized as of 4/24 on critical condition
63 2021-04-23 fainting Nausea, heavy fatigue, dizziness, fainting - 2 times. Fainted twice within 5 minutes. milder symptom... Read more
Nausea, heavy fatigue, dizziness, fainting - 2 times. Fainted twice within 5 minutes. milder symptoms lasted about 1/2 hour. Very mild similar symptoms continuing.
63 2021-04-24 palpitations, atrial fibrillation I had a A fib occurrence I had never had one before the 2nd shot. I went to the ER. They gave me 3 d... Read more
I had a A fib occurrence I had never had one before the 2nd shot. I went to the ER. They gave me 3 different medications to get back in rhythm. I was dehydrated and low on potassium so they gave me saline and potassium pills. So I got the shot at 2:30 pm and at 7:00 pm I started with the pounding in my chest. I called ask a nurse and she told me to go immediately to the ER. My pulse was 157. My blood pressure was 158/114. I was in the ER from 8:00 pm till 3:00 am. The doctor wanted to admit me but I refused. We went home when my rhythm was normal.
63 2021-04-24 fainting About 6 pm on 4/15, chills began. By 9 pm, teeth chattering and shaking with chills. At 5 am, got up... Read more
About 6 pm on 4/15, chills began. By 9 pm, teeth chattering and shaking with chills. At 5 am, got up with dog and feinted. Lay in floor, then got up, and feinted again, injuring my back. Too weak to get up. Had to lay in floor resting. Slowly scooted down the hall on my backside. Husband came on his walker and helped me up and back to bed. Tried to get up about 8:30 and fell into wall, so back to bed. Became steady in the afternoon. Spent all day in bed on 4/16 through 4/18, having chills, alternating with drenching sweats, and stomach upset. Could not eat on 4/16 and 4/17. Had headache on 4/16. Arm hurt for 3 days. Had terrible fatigue for several days. Vaccine side effects began to clear 4/19. Still pain in back.
63 2021-04-25 cardiac arrest cardiac arrest, ventricular fibrillation, new large brain aneurysm. anoxic brain injury. She was fo... Read more
cardiac arrest, ventricular fibrillation, new large brain aneurysm. anoxic brain injury. She was found in her car down with cardiac arrest in ventricular fibrillation. She was intubated and found to have brain aneurysm that is new. She suffered anoxic brain injury and was in vegetative state. aneurysm is left alone due to poor neurologic function per neurosurgery. Pt is placed on comfort care and waiting for expiration
63 2021-04-26 palpitations palpitations, fatigue, mental fogginess within 72 hours of second vaccine
63 2021-04-26 fainting Patient reported having a syncopal episode at home after her first dose of Moderna vaccine. Patient ... Read more
Patient reported having a syncopal episode at home after her first dose of Moderna vaccine. Patient received her 2nd dose of Moderna in our clinic and reported dizziness while in post-vaccination monitoring. Patient was given water and juice. Patient waited an additional 20 minutes for a total of 35 minutes. Patient was observed ambulating and was able to independently leave the facility, reporting that she felt better and denied dizziness.
63 2021-04-27 blood clot a week after receiving the vaccine I started feeling shortness of breath. It progressively got worse... Read more
a week after receiving the vaccine I started feeling shortness of breath. It progressively got worse and on April 23, 21 was admitted into Hospital with blood clots to the left leg and to my lungs.
63 2021-04-28 chest discomfort Moderna COVID-19 Vaccine EUA: patient presents to clinic for follow-up for all-over body rash that d... Read more
Moderna COVID-19 Vaccine EUA: patient presents to clinic for follow-up for all-over body rash that developed nine days after second vaccine dose. Patient also reports myalgias, sore arm, and chest tightness after vaccination that resolved. Patient initially seen 12 days after vaccination and reports they tried topical cortisone, diphenhydramine, and loratadine and states topical cortisone provided some temporary relief. Patient advised to continue oral antihistamines and topical steroids. Three days later patient returned to clinic and prescribed prednisone and will follow-up with allergy clinic.
63 2021-04-29 chest discomfort ~20-30 minutes during monitor period, pt developed mild chest tightness and SOB, both partially but ... Read more
~20-30 minutes during monitor period, pt developed mild chest tightness and SOB, both partially but not totally reliveved by rescue inhaler. Pt requested to be placed on O2 and then transported to the hospital.
63 2021-04-29 skin turning blue Blue hands bilaterally when outside walking - Raynaud's phenomenon. Placed hands in pockets to help... Read more
Blue hands bilaterally when outside walking - Raynaud's phenomenon. Placed hands in pockets to help warm up and when home put in warm water about 15 min later. Hands pinked up
63 2021-04-29 loss of consciousness Patient reported feeling weakness and heaviness in legs, became dizzy and passed out. Husband called... Read more
Patient reported feeling weakness and heaviness in legs, became dizzy and passed out. Husband called 911 and patient was transported to the hospital.
63 2021-04-29 fainting Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-S... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Additional Details: patient went unresponsive within 10 minutes of vaccine during monitoring period, with faint pulse and shakiness for more than 90 second. she became responive, and started to feel better. EMS arrived, checked her out, and found all vitals were normal and she declined trip to ER. She followed up with MD she said at check up phone call and was advised not to get 2nd covid shot
63 2021-04-30 heart rate increased Nausea, dizziness, rapid heart rate, fever, chills, weak muscles, sore joints, swollen tongue, dry m... Read more
Nausea, dizziness, rapid heart rate, fever, chills, weak muscles, sore joints, swollen tongue, dry mouth. 7:30am -8pm.
63 2021-04-30 loss of consciousness, fainting became unresponsive; hemorrhagic shock; syncope; abdominal pain; wasn't feeling good; nausea; vomiti... Read more
became unresponsive; hemorrhagic shock; syncope; abdominal pain; wasn't feeling good; nausea; vomiting; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (became unresponsive), SHOCK HAEMORRHAGIC (hemorrhagic shock), SYNCOPE (syncope), ABDOMINAL PAIN (abdominal pain), FEELING ABNORMAL (wasn't feeling good), NAUSEA (nausea) and VOMITING (vomiting) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Splenectomy (did get embolization but progressed to further bleeding) on 24-Apr-2021. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (became unresponsive) (seriousness criterion hospitalization), SHOCK HAEMORRHAGIC (hemorrhagic shock) (seriousness criterion hospitalization), SYNCOPE (syncope) (seriousness criterion hospitalization), ABDOMINAL PAIN (abdominal pain) (seriousness criterion hospitalization), FEELING ABNORMAL (wasn't feeling good) (seriousness criterion hospitalization), NAUSEA (nausea) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). The patient was hospitalized on 21-Apr-2021 due to ABDOMINAL PAIN, FEELING ABNORMAL, LOSS OF CONSCIOUSNESS, NAUSEA, SHOCK HAEMORRHAGIC, SYNCOPE and VOMITING. At the time of the report, LOSS OF CONSCIOUSNESS (became unresponsive), SHOCK HAEMORRHAGIC (hemorrhagic shock), SYNCOPE (syncope), ABDOMINAL PAIN (abdominal pain), FEELING ABNORMAL (wasn't feeling good), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Imaging procedure: (abnormal) abd imaging showed a large splenic subcapsular hematoma of unclear etiology (no hx of trauma) with hemoperitoneum. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ABDOMINAL PAIN (abdominal pain), NAUSEA (nausea) and VOMITING (vomiting) to have an unknown relationship. No further causality assessments were provided for LOSS OF CONSCIOUSNESS (became unresponsive), SHOCK HAEMORRHAGIC (hemorrhagic shock), SYNCOPE (syncope) and FEELING ABNORMAL (wasn't feeling good). Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provide at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provide at this time. Further information has been requested.
63 2021-05-02 blood pressure increased Brain fog, dizziness, odd pressure sensation in small of back, tingling hands and feet, pressure hea... Read more
Brain fog, dizziness, odd pressure sensation in small of back, tingling hands and feet, pressure headache, high blood pressure, difficulty concentrating or holding onto a thought, typing words backwards, handwriting briefly with left hand, letter "E" written backwards. All lasted about 5 hours. The next morning, all side effects subsided, with the exception of the brain fog, which lingered 3 days.
63 2021-05-02 fainting Onset of adverse reactions started about 12 after injection. Symptoms were muscle pain in left are f... Read more
Onset of adverse reactions started about 12 after injection. Symptoms were muscle pain in left are from injection site through neck, chills, cold sweats, nausea, and extreme fatigue. At some time during the night, I woke to use the restroom and fainted on the floor. Symptoms lasted about 24 hours after onset.
63 2021-05-03 hypertension Fever up to 104, pneumonia diagnosis, very high blood pressure over 200. Hospitalized on antibiotics... Read more
Fever up to 104, pneumonia diagnosis, very high blood pressure over 200. Hospitalized on antibiotics for 24 hours.
63 2021-05-03 fast heart rate, blood glucose increased Patient went into SVT 20 min after vaccine administration. No previous hx of this
63 2021-05-04 cerebrovascular accident Stroke; Sounded delirious; Could not form words; My blood pressure was 250 over something; This spon... Read more
Stroke; Sounded delirious; Could not form words; My blood pressure was 250 over something; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), DELIRIUM (Sounded delirious), APHASIA (Could not form words) and BLOOD PRESSURE SYSTOLIC INCREASED (My blood pressure was 250 over something) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21-2A and 014M20A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE for Rheumatoid arthritis, FOLIC ACID, ALENDRONATE SODIUM (FOSAMAX), VITAMIN B12 [VITAMIN B12 NOS] and CALCIUM for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization), DELIRIUM (Sounded delirious) (seriousness criterion hospitalization), APHASIA (Could not form words) (seriousness criterion hospitalization) and BLOOD PRESSURE SYSTOLIC INCREASED (My blood pressure was 250 over something) (seriousness criterion hospitalization). The patient was hospitalized from 03-Apr-2021 to 05-Apr-2021 due to APHASIA, BLOOD PRESSURE SYSTOLIC INCREASED, CEREBROVASCULAR ACCIDENT and DELIRIUM. On 05-Apr-2021, CEREBROVASCULAR ACCIDENT (Stroke) had resolved. At the time of the report, DELIRIUM (Sounded delirious), APHASIA (Could not form words) and BLOOD PRESSURE SYSTOLIC INCREASED (My blood pressure was 250 over something) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure systolic: 250 (High) 250. In 2021, Magnetic resonance imaging: abnormal (abnormal) confirmed that Patient had a stroke. Patient stated that on 3APR2021, 4 days after receiving the 2nd dose of the COVID-19 vaccine, she experienced a stroke. She says that she was with her daughter and per her daughter, the patient starting sounding delirious and not making any sense. She could not form words. The patient's daughter called 911. When the paramedics checked her blood pressure, the systolic number was 250. Patient does not remember the diastolic blood pressure. She was told to go to the ER. When she reached there, she says that she was having difficulty forming words. This was happening randomly and not all the time. She was admitted to the hospital for 2 days. An MRI done at the hospital confirmed that the patient had suffered a stroke. She was put on Lipitor and Plavix at the hospital and told to continue those medications for a month. She was discharged from the hospital and sent back home on 5APR2021. She states that with all the tests that were done at the hospital, the doctors are unsure what could have caused the stroke. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
63 2021-05-04 fast heart rate, palpitations adverse reaction to vaccine product Patient with history of multiple severe antibiotic allergies (sh... Read more
adverse reaction to vaccine product Patient with history of multiple severe antibiotic allergies (she refered to as anaphylaxis) reported onset of similar symptoms less than 15 minutes after vaccine administration today. Reported itching and swelling of ear canals. Some swelling seen on examination. Patient given epipen and 50 mg diphenhydramine IM. EMS called. Patient reported neck tightness, stiff muscles and hives. Given dexamethasone 4 mg IM. Patient reported confusion and racing heart. Denies chest pain and SOB. Vitals monitored closely throughout with good 02 sats. Consistent BP of 140-160/80's and fluctuating tachycardia. EMS arrived and transported patient to ER for further eval. I suspect patient was having a severe allergic reaction, but also presented as having acute panic attack. Advised against getting second Moderna vaccine. Patient should follow up with her PCP. Start dexAMETHasone sodium phosphate 4 mg/mL injection solution 1 mL every day Start EpiPen 0.3 mg/0.3 mL injection, auto-injector 1 auto Start diphenhydrAMINE 50 mg/mL injection syringe 1 mL
63 2021-05-05 palpitations, atrial fibrillation I felt fatigued, tired , no appetite and ran low grade fever starting the evening after vaccination.... Read more
I felt fatigued, tired , no appetite and ran low grade fever starting the evening after vaccination. This continued with dry heaves, poor appetite and vomiting Sunday and Monday. Tuesday evening I ran fever of 102.4, took Tylenol and promptly vomited. Then I noticed my heart racing. Took my BP which was 107/60 and hear rate 150s. I had my brother take me to the Medical Center where I was admitted for observation. I was told the I was in A Fib with rapid ventricular response. I was given 15 mgm of dialtizem IV x two, one liter of IVF and then converted to NSR. I was admitted overnight for observation
63 2021-05-06 cardiac arrest, chest pain Client admitted to the hospital on 4/26/2021 with Covid symptoms, body aches, SOB and chest pain. Di... Read more
Client admitted to the hospital on 4/26/2021 with Covid symptoms, body aches, SOB and chest pain. Diagnosed with Covid -19 pneumonia. Antigen test positive for Covid-19 on 4/26/2021. Subsequent admission on 5/4/2021 with cardiac arrest secondary to hypovolemic shock from UGI bleed, likely variceal. Client died 5/5/2021.
63 2021-05-09 palpitations Shortness of breath, severe; heart palpitations; uncontrollable dry cough, gagging; hot flashes, chi... Read more
Shortness of breath, severe; heart palpitations; uncontrollable dry cough, gagging; hot flashes, chills, slight fever, sore throat, fatigue.
63 2021-05-09 pulmonary embolism Acute hypoxic respiratory insufficiency secondary to Covid pneumonia with concerns for possible supe... Read more
Acute hypoxic respiratory insufficiency secondary to Covid pneumonia with concerns for possible superimposed bacterial pneumonia. feeling increasingly sick, with fevers, nausea, chills, shortness of breath, loss of taste, and poor appetite. Please take Augmentin 1 g twice daily for 1 day. Please continue taking dexamethasone 6 mg once daily for the next 5 days. Please start taking Lipitor 40 mg once daily.
63 2021-05-10 blood pressure increased Same day experienced fever, chills-extreme, sweating- extreme for 3-4 days. Recovered in 8 days. Swe... Read more
Same day experienced fever, chills-extreme, sweating- extreme for 3-4 days. Recovered in 8 days. Sweating continued but nit as severe. Two weeks later another cold/ flu like symptoms fever chills sweats but not as severe. May 9th one month later I get what I think is Covid arm rash in right shoulder going up neck and in right breast. Raised bumps that itch. Also prior to this episode developed extremely dry lips with bumps on inside of lower lip. Never had this before, EVER!
63 2021-05-10 loss of consciousness After the vaccine was administered he passed out about 5 seconds after. He did not hit his head or... Read more
After the vaccine was administered he passed out about 5 seconds after. He did not hit his head or report any effects of falling to the ground from a seated position.
63 2021-05-10 blood clot epiploic appendages; nausea; dizziness; blood clot; pain on left side of abdomen; This spontaneous c... Read more
epiploic appendages; nausea; dizziness; blood clot; pain on left side of abdomen; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D17B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced THROMBOSIS (blood clot) (seriousness criterion medically significant) and ABDOMINAL PAIN (pain on left side of abdomen). On 03-May-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (nausea). On an unknown date, the patient experienced EPIPLOIC APPENDAGITIS (epiploic appendages). At the time of the report, THROMBOSIS (blood clot), ABDOMINAL PAIN (pain on left side of abdomen), DIZZINESS (dizziness), EPIPLOIC APPENDAGITIS (epiploic appendages) and NAUSEA (nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Computerised tomogram: epiploic appendagitis Epiploic Appendagitis. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment given included antibiotic amoxicillin/clavulanic acid. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding this events has been provided at this time. Further information has been requested.
63 2021-05-11 blood glucose increased I have had a high fasting blood sugar, severe fatigue, lightheadedness, brain fog.
63 2021-05-11 blood pressure fluctuation Pt received the second dose of Moderna and after the vaccine was given, pt went to sit in the waitin... Read more
Pt received the second dose of Moderna and after the vaccine was given, pt went to sit in the waiting area...pt alerted one of the technicians and alerted that she wasn't feeling well. RPH gave the pt a bottle of water and a cold pack and measured her BP which was low (69/88) at the moment. RPH rechecked the BP 5 minutes later and came to be normal again. Pt wanted to lie down so a mat, pillow, and blanket was provided for the pt to lie down in the IMZ room. After 15 minutes of laying down, patient felt alot better and was ok to leave. Pt was thankful for the care she received and we will follow up in around 4pm to see how pt is doing.
63 2021-05-11 blood pressure increased Blood pressure was elevated; right eye is cloudy; This spontaneous case was reported by a consumer a... Read more
Blood pressure was elevated; right eye is cloudy; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure was elevated) and VISION BLURRED (right eye is cloudy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 007A21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL, LISINOPRIL and AMLODIPINE for Blood pressure high. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure was elevated) (seriousness criterion medically significant) and VISION BLURRED (right eye is cloudy) (seriousness criterion medically significant). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure was elevated) and VISION BLURRED (right eye is cloudy) outcome was unknown. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not Applicable. Company comment:Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
63 2021-05-11 heart rate increased neuropathy in her right hand; Heart rate of 150; cough; hair loss; red spots on face; no appetite; G... Read more
neuropathy in her right hand; Heart rate of 150; cough; hair loss; red spots on face; no appetite; GI upset; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy in her right hand) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product TUCATINIB (TUKYSA) for Neoplasm breast. Concurrent medical conditions included Malignant neoplasm of female breast. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TUCATINIB (TUKYSA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neuropathy in her right hand) (seriousness criterion medically significant), HEART RATE INCREASED (Heart rate of 150), COUGH (cough), ALOPECIA (hair loss), ERYTHEMA (red spots on face), DECREASED APPETITE (no appetite) and ABDOMINAL DISCOMFORT (GI upset). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy in her right hand), HEART RATE INCREASED (Heart rate of 150), COUGH (cough), ALOPECIA (hair loss), ERYTHEMA (red spots on face), DECREASED APPETITE (no appetite) and ABDOMINAL DISCOMFORT (GI upset) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood bilirubin: elevated (High) Elevated. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. On 12-MAR-2021, it was reported that the patient was in the emergency room (ER). She was complaining of heart rate of 150 and cough. She states, "I got Moderna Vaccine the day before I started my Tukysa, I am not sure which one or both are doing this. On 03-MAY-2021, it was reported that Patient reports that Tukysa was on hold for about a week from 16-APR-2021 to 22-APR-2021 because her bilirubin level was elevated. Patient reports that she also has little red spots on her face, they do not itch and are not painful. Patient states that she has no appetite and has a lot of GI upset. Patient states that she is beginning to lose her hair. Patient also states that she had some neuropathy in her R hand. This case refers to a 63-yearold female patient receiving cancer treatment who experienced some events after the administration of the vaccine on an unspecified date. Very limited information regarding these events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: additional adverse events were updated, case upgraded to serious, action taken with Tukysa was updated.; Sender's Comments: This case refers to a 63-yearold female patient receiving cancer treatment who experienced some events after the administration of the vaccine on an unspecified date. Very limited information regarding these events has been provided at this time. Further information has been requested.
63 2021-05-11 palpitations Low temp, low BP, then temp 100.4, nausea, vomiting, chills, headache, (which all lasted for several... Read more
Low temp, low BP, then temp 100.4, nausea, vomiting, chills, headache, (which all lasted for several days. I didn?t feel better for a week after the first shot. ) Heart thumping which has lasted two months. I now have to take Lisinopril to lower my BP. My pulse goes from 41 to 71 throughout the day, and this started when I had the sickness reaction after the first shot. I was sick for two and a half days (headache, chills, temp of 100.2) after the second shot. I had the second shot April 12 at 4pm and started to feel bad at 4:30am on April 13.
63 2021-05-11 fainting Delayed reaction. On day 5, I woke up fatigued, with some body aches, and extreme cold. I was leth... Read more
Delayed reaction. On day 5, I woke up fatigued, with some body aches, and extreme cold. I was lethargic all that day. On day 6, more of the same above symptoms. I stayed in bed most of those two days. On day 7, I was improved and was able to function normally. At no time, during these two days did I run a fever. I realize most of these symptoms are common, but the reason I wished to report them is the fact that it was so delayed.
63 2021-05-12 loss of consciousness, fainting Walked out to get the mail 5 hours after receiving the vaccine. Feeling fine, just some soreness in... Read more
Walked out to get the mail 5 hours after receiving the vaccine. Feeling fine, just some soreness in the arm. Had collected the mail in my hand and the next thing I knew I was on the pavement in the street. My face took the brunt of the fall after fainting/blacking out.
63 2021-05-13 fainting Pt w/hx of COPD/current smoker presented to ED w/2 week episode of dizziness, syncopy, poor appetite... Read more
Pt w/hx of COPD/current smoker presented to ED w/2 week episode of dizziness, syncopy, poor appetite, chills, N/V/D with no SOB or fevers. Pt stated that she may have had COVID infxn months ago prior to receiving Moderna vaccines on 2/25 & 3/25. CXR impression consistent w/known COVID-19 infection upon workup and subsequent positive COVID test (5/8). Admitted on 5/5 for additional management of acute hypoxic respiratory failure d/t bilat PNA. Pt received dexamethasone, convalescent plasma, and tocizumab and is still in hospital requiring 9L of O2.
63 2021-05-14 heart rate increased, palpitations 4/23/21 at 1435: Pt. has h/o allergic reactions to Codeine & most antibiotic Does not carry an Epi-p... Read more
4/23/21 at 1435: Pt. has h/o allergic reactions to Codeine & most antibiotic Does not carry an Epi-pen. No other significant Med. Hx 1315: Covid vaccine #2 given. Pt. instructed to wait 30 minutes d/t allergy history. 1340: Pt. c/o rapid pulse. HR - 124. 1343: VS: BP - 183/102 - LA (reg. cuff) HR - 109 R - 22 1345: VS: BP - 174/85 - RA (Lg. cuff) HR - 94 Pt. denies any tingling in lips 1350: VS: BP - 174-93 HR - 94 R - 18 1400: Pt. states still 0 feeling well, likeheart racing again. VS: BP - 164/97 HR - 101 Given 50mg liquid Benadryl PO - Husband arrived 1401: Pt. states she is having difficulty breathing. Called emergency number - Epinephrine drawn up & ready 1405: VS BP-171/89 HR -102 EMS arrived Pt. began feeling better upon EMS arrival. VS improving. EMS stayed ~15-20min. & pt. feeling well, deciding 0 ambulance ride to hospital. Husband took pt. home ~1425 & will monitor wife for any s/s resp. distress. Couple lives 2 blocks from EMS headquarters. Instructed to call office if any ?s, & call emergency number if any respiratory distress.
63 2021-05-15 deep vein blood clot, fibrin d dimer increased DVT of bilateral lower extremities and bilateral pulmonary edema. Treated with apixaban 5 mg per st... Read more
DVT of bilateral lower extremities and bilateral pulmonary edema. Treated with apixaban 5 mg per standard dosing. Hospitalized 4/27/2021 and discharged 5/4/2021. Patient convalescing at home. Tentative return to work date 5/24/2021. Follow-up hematologist consult due on 5/10/2021 and follow-up pulmonary consult due on 5/19/2021.
63 2021-05-15 haemoglobin decreased since 10 days after vaccine, patient has had evening fevers (5 weeks at this time). initially she h... Read more
since 10 days after vaccine, patient has had evening fevers (5 weeks at this time). initially she had a sore throat with the fevers but this has resolved. The cause of the fevers, despite extensive evaluation, remains unknown.
63 2021-05-16 heart rate increased 4 hours after injection: Fever 99°, chills mild headache. 8 hours after injection: Fever 101.8, chi... Read more
4 hours after injection: Fever 99°, chills mild headache. 8 hours after injection: Fever 101.8, chills, severe migraine headache. 24 hours after injection: Fever 101.4, chills, severe migraine headache, eye pain, lethargic, weakness, no appetite, rapid heartbeat of 125 bpm. Day 2: Fever: 99.6, headache, no appetite, lethargic, heartbeat between 108-120 bpm Day 3: Fever 99, mild headache, no appetite, lethargic, heartbeat 94 bpm, weakness, unsteadiness Day 4: No fever, heartbeat 84 bpm, some appetite, weakness, lethargic, unsteadiness. Day 5: No fever, heartbeat normal, appetite returned, weakness. Day 6: Normal
63 2021-05-16 fainting May 5 ,2021 patient became dizzy, diarrhea, syncopal poor appetite, feeling lethargic, having chills... Read more
May 5 ,2021 patient became dizzy, diarrhea, syncopal poor appetite, feeling lethargic, having chills. "I couldn't keep anything down"
63 2021-05-17 ischaemic stroke Had an Ischemic Stroke. Hospitalized via ambulance 4/23-4/29/2021.
63 2021-05-20 atrial fibrillation The patient states she woke up the morning after the vaccination and was in A-Fib. She states she ha... Read more
The patient states she woke up the morning after the vaccination and was in A-Fib. She states she has a pacemaker and has been in A-Fib before, but has not had an episode in "quite a while" She wondered if the episode could be related to the vaccine.
63 2021-05-20 fainting, loss of consciousness Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Urin... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Urinated on herself-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Immediately after vaccination she started to feel "awful" and unable to describe exactly what was wrong. She was lightheaded, shaky and dizzy. She lost consciousness for about 1-2 minutes and paramedics were called. Once consciousness was regained, she lied down and started to feel better. She continued to lie down until paramedics showed up and assessed her. She was feeling better and was not taken to the hospital.
63 2021-05-21 blood pressure decreased almost immediately following administration of vaccine, patient began sweating, seeing spots (blue t... Read more
almost immediately following administration of vaccine, patient began sweating, seeing spots (blue to black) and her blood pressure dropped to 82/55; sat with patient, monitored blood pressure while her husband fanned her with paper, dabbed her with cold paper towel and ice pack; blood pressure slowly climbed and returned to her "normal" (131/74) at 3:50pm (half hr after vaccine); patient was able to stand, walk, and left at 4:00pm
63 2021-05-21 palpitations, blood pressure fluctuation Olfactory hallucinations; Blood pressure spikes; Did not receive second dose; Agitated; Rapid heart ... Read more
Olfactory hallucinations; Blood pressure spikes; Did not receive second dose; Agitated; Rapid heart beat; Tingly lips; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, OLFACTORY (Olfactory hallucinations) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced AGITATION (Agitated), PALPITATIONS (Rapid heart beat) and PARAESTHESIA ORAL (Tingly lips). On an unknown date, the patient experienced HALLUCINATION, OLFACTORY (Olfactory hallucinations) (seriousness criterion medically significant), BLOOD PRESSURE FLUCTUATION (Blood pressure spikes) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose). On 02-Mar-2021, AGITATION (Agitated), PALPITATIONS (Rapid heart beat) and PARAESTHESIA ORAL (Tingly lips) had resolved. At the time of the report, HALLUCINATION, OLFACTORY (Olfactory hallucinations) and BLOOD PRESSURE FLUCTUATION (Blood pressure spikes) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product used was not provided by the reporter. The patient called in to report that she did not receive the 2nd dose. She reported that she was still experiencing side effects from the 1st dose of the vaccine. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-May-2021 will be submitted with initial report. Follow-up information included new adverse events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
63 2021-05-22 heart rate increased The patient's daughter came in to get some antibiotics for her mother, and reported that her mother ... Read more
The patient's daughter came in to get some antibiotics for her mother, and reported that her mother had been diagnosed with COVID pneumonia in both of her lungs. Two (2) days after her second shots, patient began to have an increased heart rate and swelling in her legs. She went to the ER and was told that her blood was "getting thicker". She had not had any clotting issues in the past that she was aware of. She was given IV antibiotics during her hospital visit. She was instructed by her doctor to take over-the-counter aspirin twice a day and finish her antibiotic regimen. The daughter classified her mother has "perfectly healthy" before her second shot.
63 2021-05-22 fast heart rate About 45 mins after the injection I started to have an episode of SVT and tried my usual methods to ... Read more
About 45 mins after the injection I started to have an episode of SVT and tried my usual methods to reset. This lasted 25 mins. I have never had an episode that lasted that long. Then 1 week to the day on 2/4/21 at 10 am I noticed the "covid arm with a knot at the injection site". No itching. Later that night (2/4/21) I noticed more redness and induration at the site so by Friday the 5th I had streaking of redness, induration and pain from the injection site along with lymph nodes. Saw the doctor and treated for a cellulitis. Ran a fever for 2 days until medication kicked in and then site started to look better by Monday the 8th of February. I did not receive the 2nd dose.
63 2021-05-23 heart rate irregular Previous to getting the vaccine I would only occationally have an irregular heartbeat (once or twice... Read more
Previous to getting the vaccine I would only occationally have an irregular heartbeat (once or twice a month, but after 4 days of getting the vaccine I was getting the heartbeat irregularity more often (every day).
63 2021-05-23 palpitations, heart rate increased Heart palpitations, increased pulse rate at rest up to 104 bpm, vertigo, ringing in right ear starti... Read more
Heart palpitations, increased pulse rate at rest up to 104 bpm, vertigo, ringing in right ear starting around March 10 or about 2 weeks after 2nd Moderna shot.
63 2021-05-23 troponin increased, chest pain Within 5 hours after 2ND Moderna vaccine, I developed really severe flu symptoms along with chest &... Read more
Within 5 hours after 2ND Moderna vaccine, I developed really severe flu symptoms along with chest & back pain.
63 2021-05-24 blood glucose increased Patient received third dose of Covid vaccine. No treatment given, patient told to report adverse eve... Read more
Patient received third dose of Covid vaccine. No treatment given, patient told to report adverse events to pharmacy. Patient reported tiredness, headache, joint pain, high blood sugars and chills
63 2021-05-24 loss of consciousness Woke up at 5 AM shivering uncontrollably, weak, unable to move, sweating, feeling feverish, whole bo... Read more
Woke up at 5 AM shivering uncontrollably, weak, unable to move, sweating, feeling feverish, whole body aching. Needed to use heating pad for cold relief (no fever on thermometer). Took Tylenol; symptoms lasted 36 hours; passed out 2x upon standing up to use toilet. Dizzy, nauseous, blurry vision, headache, unable to eat, thirsty, very sleepy; took Tylenol every 6 hours for slight relief. Sick for 2 days but symptoms lessened after 36 hours. Terrible experience. Site of shot was the size of an orange, rash-wise, and very painful for 3 days.
63 2021-05-24 pulmonary embolism Patient presents with 7 day history of shortness of breath. Ct angiogram showed multiple pulmonary ... Read more
Patient presents with 7 day history of shortness of breath. Ct angiogram showed multiple pulmonary emoblism with ventricular strain. Patient required EKOS procedure for clot dissolution and bridging from Lovenox to warfarin.
63 2021-05-25 chest discomfort Fever, pain throughout body, chills, extremly tired, headache, body aches. no appetite. Asthma flare... Read more
Fever, pain throughout body, chills, extremly tired, headache, body aches. no appetite. Asthma flared up with cough, tight chest, hard to breathe .went to Dr next day was put on prednsione as all other aliments went away except asthma. Have been using symbicort, prednisone, 3 seperate prescriptions , Z Pack, albuterol. cough medicine DM , claritin, nebulizer and nothing is clearing up the breathing or coughing spells.
63 2021-05-25 loss of consciousness The morning after I received my second vaccine I began feeling nauseated, then I started sweating pr... Read more
The morning after I received my second vaccine I began feeling nauseated, then I started sweating profusely, and as I started to get a wash cloth to try to cool myself, I passed out. I came to shortly thereafter, but was weak the rest of that day. The second day after the vaccine I did go to work, but I battled my asthma all day. I had to use my emergency inhaler twice, and at one point thought I was going to have to go to the ER before getting it under control, but I did not have to.
63 2021-05-25 palpitations For several days I had racing heart beat and my head felt like it was being reconstructed--not pain,... Read more
For several days I had racing heart beat and my head felt like it was being reconstructed--not pain, but could feel the reconstruction, but it wasn't until about 3 days later I noticed my tongue was foamy. I didn't realize how disoriented I was until someone mentioned that 5 days later. I did attempt to sleep a lot to let the crazy pass over me. I'm now a week later, with only noticing slight head adjustments going on in there, but I was able to work through most of this, although the racing heart beat was the most scary and the head thing was distrubing.
63 2021-05-26 nosebleed Nose bleed on left side, busted blood vessel in left eye the next day. Eye has still not cleared up ... Read more
Nose bleed on left side, busted blood vessel in left eye the next day. Eye has still not cleared up fully but it is looking better.
63 2021-05-26 loss of consciousness Began with headache, body aches, and feeling tired. Progressed to hives on stomach - called ER recom... Read more
Began with headache, body aches, and feeling tired. Progressed to hives on stomach - called ER recommended I take Benedryl, I did. Hives progressed and worsened, I passed out and my husband had to call 911. I was taken by ambulance to the ER and admitted to the hospital. I stayed until on Monday 5/24/2021. I was released 1:30pm. Wednesday 5/27/2021 I felt jittery I called my PCP they could not get me in and recommended I go to the walk in clinc, I did and they reduced some of the medications I was put on from the hospital. I have a follow up appointment with my PCP 6/2/2021.
63 2021-05-27 fluid around the heart, inflammation of the pericardium, inflammation of the heart muscle Myocarditis, pericarditis, pericardial effusion, pulmonary effusion
63 2021-05-31 fainting, loss of consciousness I wasn't feeling too ill the day of the vaccination and only had a sore arm when going to bed that f... Read more
I wasn't feeling too ill the day of the vaccination and only had a sore arm when going to bed that first night. However, when I woke up the next day, I was quite ill. I never ran a temperature but I had diarrhea and vomiting and could not keep any liquid down. As I was kneeling beside the toilet to vomit, I completely lost consciousness, fainted, and bruised a rib on the fall. I finally was able to get Gatorade to stay down. The arm of the vaccination site doubled in size due to edema and my arm was red from the top of my shoulder to the bottom half of my arm. It was also very itchy. Completely out that first day, just sleeping and laying on the couch downstairs. Four days out, the arm was still ballooned up and red. Five days out, the redness started to disappear. Still some edema and redness on the sixth day out, still fatigued, but gaining a little more normalcy. Huge bruise from faint on my left rib cage. Appetite now back to normal.
63 2021-06-01 palpitations On the day I received my second vaccination, I went home and started to not feel well. About 4PM, I ... Read more
On the day I received my second vaccination, I went home and started to not feel well. About 4PM, I had fatigue, body pain. I thought that if I ate something, I wouldn't feel so bad. It didn't work. At 8PM, I took ibuprofen. The following day, I didn't feel well. A week later, I went to the ER at about 3 AM. I had serious heart palpitations and panic attack. I took a few aspirins, which helped. They wanted to admit me to the hospital to see if I had a heart condition, but I didn't want that. The following day, I signed myself out and went to my doctor. I had gone to my cardiologist, and I was told I was fine.
63 2021-06-02 atrial fibrillation, heart flutter, heart rate irregular, hypotension, palpitations After second vaccination: Initially: Sudden experience of very low BP - 91/41 - fatigue, shortness ... Read more
After second vaccination: Initially: Sudden experience of very low BP - 91/41 - fatigue, shortness of breath, dizziness, unable to go to work. Vertigo. One week later and continuing: heart palpitations, a fib, fluttering, shortness of breath, dizziness, fatigue, nausea, low BP, and unable to go to work.
63 2021-06-02 cerebrovascular accident stroke
63 2021-06-02 platelet count decreased, haemoglobin decreased, low platelet count Pt. presents to ED on 06/02/2021 at 0900 with c/o dizziness and sweaty while she was doing dishes. ... Read more
Pt. presents to ED on 06/02/2021 at 0900 with c/o dizziness and sweaty while she was doing dishes. Pt. reported "feeling like she was drunk". Pt. denied any pain or SOB. Pt. does have hx. of A-fib. Pt. also admitted to not eating any breakfast. Pt. was discharged to home with diagnosis of thrombocytopenia, instructed to hold her Eliquis and to contact her PCP in the next few days. EKG did not show A. Fib so PA-C felt okay to hold Eliquis.
63 2021-06-02 transient ischaemic attack Ischemic TIA
63 2021-06-03 heart attack I21.4 - Non-ST elevation (NSTEMI) myocardial infarction
63 2021-06-03 chest pain pinpoint pain mid chest for 1 day, body aches the next day for about 8 hours, noticed hair loss wi... Read more
pinpoint pain mid chest for 1 day, body aches the next day for about 8 hours, noticed hair loss within 2 days of the shot and still losing hair 2 months later *note: retired and have had shots for many things over 20 year career--this is the first shot I've had this kind of reaction to. Thought that was worth mentioning.
63 2021-06-06 heart rate increased Fever and heart rate over 130 (while lying down) during the first day. Second day, migraine headache... Read more
Fever and heart rate over 130 (while lying down) during the first day. Second day, migraine headache and nausea. Third and fourth days, upset stomach and exhaustion. I could not eat in 2 days, just water and coconut water. I ate only vegetable puree for 3 days.
63 2021-06-07 blood pressure increased, heart rate increased, hypertension, increased heart rate I had flu like symptoms, but by evening my pulse kept going up over 100 that night. My Fitbit inform... Read more
I had flu like symptoms, but by evening my pulse kept going up over 100 that night. My Fitbit informed me of this. I checked my blood pressure because I got curious. That night it was 152/116, and it kept going up and up. I went to the doctors office, and they ordered me some medicine. But, then they told me to go to the ER. They did tests and told me I had sinus tachycardia and hypertension. They gave me medicine called metoprolol. It slowly started to bring my pulse down to about 40, but kept jumping back up. Pulse was to low, so they switched my medication to losartan.
63 2021-06-08 hypertension, heart rate increased, palpitations Woke to a pounding in my chest heart, very high blood pressure and heart rate. Have never had any of... Read more
Woke to a pounding in my chest heart, very high blood pressure and heart rate. Have never had any of those symptoms before. High heard rate and shortness of breath lasted three weeks blood pressure became normal again in a week. Resting heart rate 107 Blood tests normal EKG Normal so no obvious cause or reason why this was happeneing. Any movement made me winded.
63 2021-06-09 blood pressure fluctuation It was like a rush went down my arm and I had bump in my wrist and then a rush in my neck, my blood ... Read more
It was like a rush went down my arm and I had bump in my wrist and then a rush in my neck, my blood pressure went up and continued up for a week and fluctuated between 192/150 185/90 and 150/90. It fluctuated 30 points. The left side of my face from ear to left was numbed and had a rush and it was itchy, feel like something burned under my skin. I took steroids prescribe. I saw the doctor and check for stroke and gave me steroids. I lost my energy. The doctor gave me Steroids for 6 days. I still feel very tired and the numbness returned in my ears. Needed to rest for 1 day 1 or 2 days. I also noticed a rush across my chest. Now I have problems in remembering things.
63 2021-06-13 inflammation of the pericardium, fluid around the heart Pericarditis/pericardial effusion noted on chest CT on 4/26/2021
63 2021-06-14 loss of consciousness Passed out; Feels worn out; Cramps like she never did before; Broke out in hives; This spontaneous c... Read more
Passed out; Feels worn out; Cramps like she never did before; Broke out in hives; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant), MUSCLE SPASMS (Cramps like she never did before) and URTICARIA (Broke out in hives). On an unknown date, the patient experienced FATIGUE (Feels worn out). The patient was hospitalized for 2 days due to LOSS OF CONSCIOUSNESS. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), MUSCLE SPASMS (Cramps like she never did before), URTICARIA (Broke out in hives) and FATIGUE (Feels worn out) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Haemoglobin: abnormal (abnormal) out of whack. The patient stated she experienced cramps like she never did before, broke out in hives everywhere, passed out, and now feels worn out. Th patient reported she did not experience any side effects from the first dose of the vaccine, which she received a few weeks prior. The patient noted she had never taken drugs prior to her second dose administration and she was perfectly healthy until now. Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medications, if any, were not provided by the reporter. Treatment medications also included steroids (unspecified) at the hospital, and an antihistamine (unspecified). Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
63 2021-06-15 cardiac failure congestive SOB CHF
63 2021-06-15 chest discomfort, chest pain Two days after I had my second Moderna shot, I began having severe shortness of breath, no appetite ... Read more
Two days after I had my second Moderna shot, I began having severe shortness of breath, no appetite and chest pain. On the 2nd day after my flu-like symptoms had disappeared, I woke up feeling like someone was sitting on the middle of my chest. I have never in my life experienced that before and it scared me to death! I was also have sporadic shortness of breath over the silliest of things - like vacuuming, walking up a few stairs, washing dishes, etc. Keep in mind - I have exercised all my life so this was very unusual for me. The tightness in my chest happened several times over the next few weeks - at different times of day and night - and even in bed. All those symptoms disappeared about 2 months after the second shot. After reading some people had heart inflmation after the second dose, I Googled it and alot of those symptoms were the same ones I had.
63 2021-06-15 chest pain, palpitations, cardiac arrhythmia Extreme headache lasting for two days. Worse than any migraine I?ve had. I could stand the headach... Read more
Extreme headache lasting for two days. Worse than any migraine I?ve had. I could stand the headache but the other symptoms need to be reported. SEVERE Chest pains. Heart Palpitations lasting for two and 1/2 days. I was definitely throwing PVC?s and at times I thought I was having a heart attack. I almost called 911. This scared me so bad that I do not intend to get the second injection.
63 2021-06-15 hypertension nephrotic syndrome; minimal change disease; focal acute interstitial nephritis; mild acute tubular i... Read more
nephrotic syndrome; minimal change disease; focal acute interstitial nephritis; mild acute tubular injury; uncontrolled hypertension; foamy urine; Hypoalbuminemia; proteinuria; hyperlipidemia; Product dose omission; fatigue; dyspnea; progressive anasarca; periorbital edema; This literature-non-study case was reported in a literature article and describes the occurrence of NEPHROTIC SYNDROME (nephrotic syndrome), GLOMERULONEPHRITIS MINIMAL LESION (minimal change disease), TUBULOINTERSTITIAL NEPHRITIS (focal acute interstitial nephritis), RENAL TUBULAR INJURY (mild acute tubular injury) and DYSPNOEA (dyspnea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension and Tobacco use disorder (dependence). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced GENERALISED OEDEMA (progressive anasarca), PERIORBITAL OEDEMA (periorbital edema), DYSPNOEA (dyspnea) (seriousness criterion medically significant) and FATIGUE (fatigue). On an unknown date, the patient experienced NEPHROTIC SYNDROME (nephrotic syndrome) (seriousness criterion medically significant), GLOMERULONEPHRITIS MINIMAL LESION (minimal change disease) (seriousness criterion medically significant), TUBULOINTERSTITIAL NEPHRITIS (focal acute interstitial nephritis) (seriousness criterion medically significant), RENAL TUBULAR INJURY (mild acute tubular injury) (seriousness criterion medically significant), HYPERTENSION (uncontrolled hypertension), URINE ABNORMALITY (foamy urine), HYPOALBUMINAEMIA (Hypoalbuminemia), PROTEINURIA (proteinuria), HYPERLIPIDAEMIA (hyperlipidemia) and PRODUCT DOSE OMISSION ISSUE (Product dose omission). The patient was treated with VALSARTAN (oral) for Renin-angiotensin system inhibition, at a dose of 80 mg twice a day; DIURETICS for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE (METHYLPREDNISOLON [METHYLPREDNISOLONE]) (intravenous) for Adverse event, at a dose of 500 mg, pulse, for 3 days and PREDNISONE (oral) for Adverse event, at a dose of 1 mg/kg,unk. At the time of the report, NEPHROTIC SYNDROME (nephrotic syndrome), GLOMERULONEPHRITIS MINIMAL LESION (minimal change disease), TUBULOINTERSTITIAL NEPHRITIS (focal acute interstitial nephritis), RENAL TUBULAR INJURY (mild acute tubular injury), HYPERTENSION (uncontrolled hypertension), URINE ABNORMALITY (foamy urine), GENERALISED OEDEMA (progressive anasarca), PERIORBITAL OEDEMA (periorbital edema), DYSPNOEA (dyspnea), HYPOALBUMINAEMIA (Hypoalbuminemia), PROTEINURIA (proteinuria), HYPERLIPIDAEMIA (hyperlipidemia), PRODUCT DOSE OMISSION ISSUE (Product dose omission) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Biopsy kidney: minimum change disease (abnormal) pathology confirmed minimal change disease with mild acute tubular injury and a focal acute interstitial nephritis was also present. Four of 69 sampled glomeruli were globally sclerosed. There was 10% tubulointerstitial fibrosis. The glomeruli were found to have 100% foot process effacement. In April 2021, Blood albumin: 0.7 g/dl (abnormal) 0.7 g/dl. In April 2021, Blood cholesterol: 450 mg/dl mg/dl (abnormal) 450 mg/dl. In April 2021, Blood creatinine: 1.48 mg/dl mg/dl (abnormal) 1.48 mg/dl baseline was 0.7mg/dl. In April 2021, Blood pressure measurement: 181/82 mmhg mmHg (abnormal) 181/82 mmHg. In April 2021, Blood triglycerides: 221 mg/dl mg/dl (abnormal) hyperlipidemia. In April 2021, Creatinine renal clearance: 13.4 g g (abnormal) 13.4 g. In April 2021, Urine analysis: 3+ proteinuria (abnormal) 3+ proteinuria (without microscopic hematuria). mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NEPHROTIC SYNDROME (nephrotic syndrome), GLOMERULONEPHRITIS MINIMAL LESION (minimal change disease), TUBULOINTERSTITIAL NEPHRITIS (focal acute interstitial nephritis), RENAL TUBULAR INJURY (mild acute tubular injury), HYPERTENSION (uncontrolled hypertension), URINE ABNORMALITY (foamy urine), GENERALISED OEDEMA (progressive anasarca), PERIORBITAL OEDEMA (periorbital edema), DYSPNOEA (dyspnea), HYPOALBUMINAEMIA (Hypoalbuminemia), PROTEINURIA (proteinuria), HYPERLIPIDAEMIA (hyperlipidemia) and FATIGUE (fatigue) to be possibly related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (Product dose omission). No prior history of renal failure. No concomitant medications reported. Patient advised to forgo the second dose of mRNA-1273 vaccination. The authors believe further rechallenges or boosters of this particular vaccine in this patient would be unwise until this potential relationship is more clear. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, for the event Intentional Dose Omission of mRNA-1273, causality is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, for the event Intentional Dose Omission of mRNA-1273, causality is not applicable.
63 2021-06-15 low blood platelet count, platelet count decreased Idiopathic thrombocytopenia purpura, rash starting 1 week prior to presenting to the hospital on 6/1... Read more
Idiopathic thrombocytopenia purpura, rash starting 1 week prior to presenting to the hospital on 6/15/2021
63 2021-06-16 excessive bleeding Bleeding; Pain in hip; Flu; pain; arthritis waking up; This spontaneous case was reported by a consu... Read more
Bleeding; Pain in hip; Flu; pain; arthritis waking up; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis, Fibromyalgia and Osteoarthritis. On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 13-Apr-2021, the patient experienced INFLUENZA (Flu). In April 2021, the patient experienced ARTHRITIS (arthritis waking up) and PAIN (pain). On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant) and ARTHRALGIA (Pain in hip). At the time of the report, HAEMORRHAGE (Bleeding), ARTHRITIS (arthritis waking up), INFLUENZA (Flu) and PAIN (pain) outcome was unknown and ARTHRALGIA (Pain in hip) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Arthrogram: abnormal (abnormal) found blood in it. On an unknown date, Arthroscopy: unknown (Inconclusive) unknown and unknown (Inconclusive) unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Lab tests also included Left and right hip arthroscopy but the results were unknown. She got arthrogram of her hip done and there was blood in it and she got injected with an unspecified steroid gel. The patient also underwent a total knee replacement. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
63 2021-06-16 loss of consciousness The morning after I received the second dose, I started having severe chills and excruciating pain a... Read more
The morning after I received the second dose, I started having severe chills and excruciating pain across my back. I was sitting in my house with blankets on and freezing, but it was like summer outside. This last for two days. On the third day, the chills and pain went away, but I felt a little off. I was sitting down and went to stand up and black out. It seemed to only last a couple of seconds, but I fell on my floor. I stayed on the floor until I got my bearings back and pretty much stayed there the rest of the day. A day later, it seemed as if it had passed. I didn't contact my doctor because I feel that no one took me seriously after my first vaccination. The hospital didn't even face the fact that it could have been from the vaccination. My doctor was the same way.
63 2021-06-16 palpitations Two hours after receiving the vaccine I started having heart palpitations and SOB that lasted until ... Read more
Two hours after receiving the vaccine I started having heart palpitations and SOB that lasted until 09:00PM that night. On Friday, I experienced the same thing. Saturday, it started earlier in the day and it lasted until I went to bed at 11:00PM. On Sunday morning, when I woke, I still had the palpitations and the they were worse. All of the testing that they performed came back normal. They ruled out a heart attack and assumed I was having a panic attack. I went to see my PCP on Friday and everything checked out fine. My cousin had the same exact symptoms and she was told the same thing. I have not had any more palpitations since the last time and my breathing is good too.
63 2021-06-16 inflammation of the pericardium, chest pain chest pain, difficulty breathing, day following shot. ER hospital, admitted, pericarditis, dis... Read more
chest pain, difficulty breathing, day following shot. ER hospital, admitted, pericarditis, discharged 05/04/2021
63 2021-06-17 palpitations, cardiac arrhythmia redness, swelling left upper arm, pain decreased ROM left shoulder, fever, chills, muscle pains, wea... Read more
redness, swelling left upper arm, pain decreased ROM left shoulder, fever, chills, muscle pains, weakness, tiredness, (slept over 10 hours) joint pains. with first dose, took allergy medicines, anti inflammatory medicines, . Second dose 02/11/2021 noticed more weakness, SOB, tiredness, joint pains mainly hand pains. Episode of palpitations lasting several hours 4/11/2021. Took more allergy and anti inflammatory medicines.
63 2021-06-20 blood glucose increased pt was admitted on 6/19 with DKA, metabolic acidosis, severe oral thrush and non healing ear lesions... Read more
pt was admitted on 6/19 with DKA, metabolic acidosis, severe oral thrush and non healing ear lesions secondary to new onset type 1 diabetes. she has had no recent illnesses or infections. she takes no medications and has no known medical problems. she sees her primary care regularly and never had problems with her blood sugars before. she is very active and eats well. she has never smoked. she noticed about 2 months ago not feeling herself. she noticed 2 scabs and sores on the outside of her ears that would not heal and sudden weight loss. she then noticed polydipsia, polyuria and polyphagia and thrush in her mouth. she went to urgent care on 6/19 and her blood sugar was 474 and she was directed to the ER for evaluation where she was found to be in DKA with new type 1 diabetes and admitted to the icu on an insulin drip. She had her covid 19 vaccines on 3/3 and 3/31. No hx illnesses or infections. she takes no medications. she has never had covid 19 to her knowledge. with iv fluids, insulin and treatment for her thrush her blood sugars were better controlled and she was transferred out of the icu to the medical floor for further education on management of new diabetes and placed on lantus, humalog with meals and sliding scale. she was seen by the diabetes educator and will be following up with endocrinology after discharge. autoimmune antibody panel for LADA pending.
63 2021-06-20 heart rate increased, palpitations Dose 1 Palpitations, increased heart rate. Shortness of breath. Heart rate in the hundreds even on m... Read more
Dose 1 Palpitations, increased heart rate. Shortness of breath. Heart rate in the hundreds even on meds. Struggle to work everyday. Dose-2 01/27/2021, at 9 PM my heart rate raised, vomiting, off work for 4 days. Lethargy, loss of appetite. End of Feb, contacted PCP, I was exhausted and fatigued and struggled with any activities. Thyroid test Graves disease diagnosed. I never had issues with thyroid, no family history of thyroid problems. My levels were extremely elevated. The only treatment was surgery to remove thyroid. Third week from thyroid surgery, went back to work on 4th week, I now have to be on thyroid medication for the rest of life. Hair was thinning and nails were brittle, still going on. Discontinued all medication except for new medication of Synthroid.
63 2021-06-21 chest pain Rigors; Chest pain; pyrexia; This spontaneous case was reported by a consumer and describes the occu... Read more
Rigors; Chest pain; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Rigors), CHEST PAIN (Chest pain) and PYREXIA (pyrexia) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product TREPROSTINIL SODIUM inhalation gas for Pulmonary arterial hypertension. Concurrent medical conditions included Pulmonary arterial hypertension. On 22-Apr-2021, the patient started TREPROSTINIL SODIUM (unknown route) at an unspecified dose four times per day. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, the patient experienced CHILLS (Rigors) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and PYREXIA (pyrexia) (seriousness criterion hospitalization). The patient was hospitalized from 30-May-2021 to 31-May-2021 due to CHEST PAIN, CHILLS and PYREXIA. At the time of the report, CHILLS (Rigors), CHEST PAIN (Chest pain) and PYREXIA (pyrexia) outcome was unknown. Concomitant and treatment medications were not provided. Based on current available information and the temporal association between produce use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between produce use and the start date of the events a causal relationship cannot be excluded.
63 2021-06-22 chest pain one week after injection, patient started experiencing leg numbness/tingling, headache, left sided f... Read more
one week after injection, patient started experiencing leg numbness/tingling, headache, left sided face tingling, burning in chest. Tingling/numbness progressing to full body.
63 2021-06-23 chest pain April 18, 2021 ER visit- Dizziness, back pain, chest pain, Nausea, fatigue over the week previous t... Read more
April 18, 2021 ER visit- Dizziness, back pain, chest pain, Nausea, fatigue over the week previous to the ER visit. I came to the ER on the advice of the advice nurse because of chest pain. May 21- swelling of ankles and feet. I was unable to stand and went home from work. The swelling is increasing and continues to make standing and sitting difficult. The pain is radiating up the legs to the knees.
63 2021-06-27 chest pain 3 days after couldnt move talk. burning pain in chest moved down to arms . Same thing happened 3 da... Read more
3 days after couldnt move talk. burning pain in chest moved down to arms . Same thing happened 3 days after the 2nd vaccine. still having same issues but more frequently
63 2021-06-27 blood clot, chest pain I formed bl9od clots in rt. leg. Discovered when foot swelled. Went to PCP and later was sent to er ... Read more
I formed bl9od clots in rt. leg. Discovered when foot swelled. Went to PCP and later was sent to er for ultrasound on leg. On 6/09/2021.
63 2021-06-28 hypertension On January 12, 2021 I started to have headaches and not feeling good so I started to check my blood ... Read more
On January 12, 2021 I started to have headaches and not feeling good so I started to check my blood pressure and I realized my blood pressure was up high and I never really had a history of having high blood pressure. That's when I called the doctor but I don't remember the specific date and I told them I am having high blood pressure and I never had any issues so I thin it's the vaccine and my doctor said no, no. I went to the doctor and I don't remember the specific dates , and she prescribe me Lisinopril 2.5mg and I had to take once a day.
63 2021-06-28 troponin increased, heart rate increased, hypertension, blood pressure increased, palpitations, chest discomfort May 18, 2021 was woken up sweating profusely, heart beating fast and pounding, lightheaded, tightnes... Read more
May 18, 2021 was woken up sweating profusely, heart beating fast and pounding, lightheaded, tightness in chest. Called 911 - HR was 116, BP 177/97 then 183/102. I was taken to ER. Various tests were done. Blood test showed triponon elevated on second blood draw, 3rd test triponon decreased some. ECHO was done. Heart ok. CT with contrast was done to rule out blood clots. That was normal. Cath was done and showed 30% blockage in L main. Nitroglyercin was given and helped relieve symptoms. Kept having high blood pressure & high heart rate issues for the next 2 weeks until put on higher dose of amlodopine and beta blocker
63 2021-07-01 blood pressure increased The next day, 03/25/2021- I felt deathly tired, it lasted 3 days. I would say the fatigue lasted lon... Read more
The next day, 03/25/2021- I felt deathly tired, it lasted 3 days. I would say the fatigue lasted longer than it should, like a couple of weeks. I had to go and take a nap, which I never do. I drank a lot of fluids. I started having health problems like in April. like achy muscles, I started waking up with lower cramps, and I never had cramps before. I started feeling discomfort in the upper area where my liver is, and the discomfort steadily increased. The doctor did a urinary test, she gave me a microban 7 day antibacterial . 3 day later they called me and that liver enzymes were elevated and the doctor told me to redo the test because the doctor thought it may be an error. And my blood pressure is elevated. The doctor also did a Hepatitis C test on 07/01/2021 , because my enzymes are elevated. Just in case the test were still elevated. January 18, 2021 I had the Shingles vaccine and the Moderna. Those were the only 2 vaccines that I have taken, if I have contamination, i don't know where I would have been contaminated, except the Shingles shot or the Moderna. I don't drink alcohol.
63 2021-07-05 hypertension On February 2nd woke around 07:50 that morning wasn't feeling well but her eye was foggy and she tho... Read more
On February 2nd woke around 07:50 that morning wasn't feeling well but her eye was foggy and she thought something was in her eye but when she looked out her left eye everything went blank. Went to the hospital the same day went to the Eye Center at the hospital and then got admitted into the hospital. Did a full stroke work up and examination of the heart. Was on a heart monitor for a month only thing they found was that her high blood pressure was really high. Patient is now blind in her left eye.
63 2021-07-06 haemoglobin decreased Jaundice and dark urine was noted on May 22,2021, went to the doctors and had blood work and a CAT s... Read more
Jaundice and dark urine was noted on May 22,2021, went to the doctors and had blood work and a CAT scan done. I had liver enzymes as high as 600-700, CAT scan showed edema of the portal valve and a slightly enlarged liver. I also was diagnosed with Hemolytic Anemia. I never had any symptoms in my life like these, no family history either. My blood work now shows that everything is going back to normal with no treatment at all.
63 2021-07-06 hypertension, chest discomfort, chest pain This was my second covid vaccine, 2-3 days after receiving this dose I started experiencing chest pa... Read more
This was my second covid vaccine, 2-3 days after receiving this dose I started experiencing chest pain, and pressure neck throbbing, blood pressure extremely high, severe headache in the back of my head and neck, short of breath, leg pain and weakness. Prescribed an additional medication for my blood pressure
63 2021-07-06 loss of consciousness Loss of consciousness; Dizziness; Face injury; Fall; Feeling abnormal; Headache; Nausea; This case w... Read more
Loss of consciousness; Dizziness; Face injury; Fall; Feeling abnormal; Headache; Nausea; This case was received via FDA VAERS (Reference number: 1243359) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to antibiotic (patient has allergy to erythromycin.), Seasonal allergy (patient feels sick to stomach certain latex bandages.), Blood pressure high and High cholesterol. Concomitant products included ATENOLOL, SIMVASTATIN (SIMVASTATIN +PHARMA) and UBIDECARENONE (CO Q 10 [UBIDECARENONE]) for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness), FACE INJURY (Face injury), FALL (Fall), FEELING ABNORMAL (Feeling abnormal), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), DIZZINESS (Dizziness), FACE INJURY (Face injury), FALL (Fall), FEELING ABNORMAL (Feeling abnormal), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On 31-Mar-2021, X-ray: inconclusive (Inconclusive) Inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. patient had taken unknown vaccine for Flu-ended up in emergency room within 5 hours of shot patient had taken Vitamin Apple cider vinegar capsules (2400 mg) as concomitant drug. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
63 2021-07-06 fainting Two days later I was at dinner and I fainted.
63 2021-07-07 atrial fibrillation Went into Afib with RVR. Required treatment at emergency room. Heart rate converted. Only 7/5/21 ag... Read more
Went into Afib with RVR. Required treatment at emergency room. Heart rate converted. Only 7/5/21 again had episode of Afib, required treatment at hospital and admisson to hospital. Discharged requiring 3 medications. Now in controlled heart rate with periods of normal sinus rhythm that goes into Afib and returns to normal rhtthm
63 2021-07-08 chest pain, palpitations On June 28th, I woke up at 3:45AM with extensive chest pains. I sat up in bed for quite some time ho... Read more
On June 28th, I woke up at 3:45AM with extensive chest pains. I sat up in bed for quite some time hoping they would go away, but they did not. I moved myself to another bedroom in my house and eventually the pain subsided. I called and left a mychart message to my doctor in the morning. I spoke to a nurse and went over the situation with her. On 07/05, I had heart palpitations that lasted for 2 1/2 minutes. I went to an appointment on 07/07/2021. The PA advised that if this happens again, to go to the ER right away. PA thinks it could be Costochondritis or a coronary spasm. I have had two episodes that have occurred.
63 2021-07-08 heart attack After receiving dose 1 of the Moderna COVID19 vaccine on 4/6/2021 I suffered a heart attack (MI) on ... Read more
After receiving dose 1 of the Moderna COVID19 vaccine on 4/6/2021 I suffered a heart attack (MI) on 4/21/2021.
63 2021-07-08 palpitations, heart rate increased Symptoms: short of breath & heart palpitations after very little exertion, occasional dizziness or l... Read more
Symptoms: short of breath & heart palpitations after very little exertion, occasional dizziness or light-headedness. Treatments: (cardiologist) states he will try to get me into the heart rehab facility for monitored exercise. I am thinking I may need to get my lungs checked.
63 2021-07-08 palpitations Everything just started to get flowy, my right ear was stuffed up for a long time and it stayed like... Read more
Everything just started to get flowy, my right ear was stuffed up for a long time and it stayed like that until now, but I do not have the hearing loss I had before. The dizziness came so bad I had to call an ambulance on 05/17/2021. I was admitted for 2 days in the ER and then in a room. The second time I called an ambulance was on 06/11/2021. They gave me shots and stuff through my IV for nausea and dizziness and I told them if they were not able to do anything else I will go home and I did. I had been to my PCP, neurologist, and ENT doctor. My ears might have been stuffed up in April or May. After my first shot the only symptoms I had was my heart started pounding really fast like half hour later and I got fleshed. I did not have any symptoms with the second one, the only thing is that my arm was sore. My ENT doctor today said that I should be good. They diagnosed me with vertigo. They did blood work, EKG, and brain scan. From all the doctors that I have seen they said that I have a virus in my inner ear. They put me on 7 days of 60 mg steroid and antiviral. That did the trick, I am doing better now and nausea medicine.
63 2021-07-09 heart rate increased Pain and numbness in the left arm, itching in the body, joint pain, swelling in vaccination area, ne... Read more
Pain and numbness in the left arm, itching in the body, joint pain, swelling in vaccination area, neck and chest, faster than usual heartbeat, and still, after 6 days I feel the symptoms.
63 2021-07-10 oxygen saturation decreased, low blood oxigenation, heart rate decreased This is a continuation of a report I started that "timed out". Oximeter levels of 93-94 and pulse ... Read more
This is a continuation of a report I started that "timed out". Oximeter levels of 93-94 and pulse of 40-50 for two days. If my cat hadn't jumped on my chest, I probably would be dead right now. In 1997, I suffered cardiac arrest after hypoxia of unknown cause (mowing the lawn). At that time, I drove 5 miles to a friend's house with no detectable pulse. I arrested in the ambulance on the way to the hospital, and tests could not find a cause. After reading about COVID vaccine, it is my understanding the vaccine works by releasing MAST cells. I can only conclude that I suffered hypoxia from the release of MAST cells, following this vaccination. I've been getting regular flu shots for 25 years, and never had this happen before.
63 2021-07-12 cerebrovascular accident 3 weeks after initial dose I had a stroke. In hospital 2 weeks in rehab 2 weeks. Many CT Scans and ... Read more
3 weeks after initial dose I had a stroke. In hospital 2 weeks in rehab 2 weeks. Many CT Scans and MRI'S. Heart checked, blood work, neurologist. Reason for stroke unknown
63 2021-07-12 chest discomfort Patient had stated that they had an anaphylactic reaction with aspirin & ibuprofen. Prior to vaccin... Read more
Patient had stated that they had an anaphylactic reaction with aspirin & ibuprofen. Prior to vaccination they were asked to stay in the area for 30 minutes for observation. About 25 minutes following vaccine patient was feeling a heavy chest and tongue was feeling funny. Pharmacist administered 50mg of liquid Diphenhydramine to the patient 30 minutes following vaccination and she waited in the pharmacy area until symptoms cleared. Only symptoms when she left was a little bit of drowsiness.
63 2021-07-13 blood pressure increased The next day of receiving my Moderna vaccine, dose 2, I started to feel sick. On 06-07-2021 I had ri... Read more
The next day of receiving my Moderna vaccine, dose 2, I started to feel sick. On 06-07-2021 I had right ear pain which was intolerable. I went to see a group doctor and where I was diagnosed with stage 3 hypertension. I also had COVID-19 in March 2020. I had the vaccine 06-03-2021. started the next day did not feel well. I started with right ear ache and by Thursday my right ear ache was bad. I then went to see my PCP who took my BP. My BP levels have been 128/84 even through my pregnancies. The pain I started to have in my right ear radiate down to my neck. I went to urgent care where they took my BP and it was 167/92 and it was believed I had an ear infection. Two days ago, my doctor placed me on high blood pressure medication. Before being placed on high blood pressure medication my reading was normal of 120/82. When my blood pressure goes up the pain in my right ear goes up. Also two of my molars have been started to hurt. I also experienced brain fog, I get tired easily and I am trying to fight these symptoms all year long. Before my first vaccine I also had the shingles vaccine. My doctor wants me to wait to get my second shingle vaccine due to my high blood pressure readings.
63 2021-07-13 pulmonary embolism, atrial fibrillation Three days (03/06) I had go to the emergency room. I was diagnosed with a Pulmonary embolism. I coul... Read more
Three days (03/06) I had go to the emergency room. I was diagnosed with a Pulmonary embolism. I couldn't breathe good.
63 2021-07-15 fluid around the heart, ejection fraction decreased, chest pain Daily headaches- in process of treatment
63 2021-07-17 blood pressure increased, blood glucose increased, heart rate increased Vertigo; Sore throat; Increased heart rate; Dizziness; Nausea; Fatigue; Severe headache; Right shoul... Read more
Vertigo; Sore throat; Increased heart rate; Dizziness; Nausea; Fatigue; Severe headache; Right shoulder pain; High BP of 294/224; High blood sugar of 750; Severe allergic reaction; Tingling in the right arm; Numbness; Heaviness in both arms; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (High BP of 294/224) and BLOOD GLUCOSE INCREASED (High blood sugar of 750) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (High BP of 294/224) (seriousness criterion medically significant), BLOOD GLUCOSE INCREASED (High blood sugar of 750) (seriousness criterion medically significant), HYPERSENSITIVITY (Severe allergic reaction), PARAESTHESIA (Tingling in the right arm), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Heaviness in both arms), HEADACHE (Severe headache) and ARTHRALGIA (Right shoulder pain). On 28-Feb-2021, the patient experienced VERTIGO (Vertigo), OROPHARYNGEAL PAIN (Sore throat), HEART RATE INCREASED (Increased heart rate), DIZZINESS (Dizziness), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, BLOOD PRESSURE INCREASED (High BP of 294/224), BLOOD GLUCOSE INCREASED (High blood sugar of 750), HYPERSENSITIVITY (Severe allergic reaction), PARAESTHESIA (Tingling in the right arm), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Heaviness in both arms), VERTIGO (Vertigo), OROPHARYNGEAL PAIN (Sore throat), HEART RATE INCREASED (Increased heart rate), DIZZINESS (Dizziness), HEADACHE (Severe headache), ARTHRALGIA (Right shoulder pain), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood glucose: 750 High. On 26-Feb-2021, Blood pressure measurement: 294/224 High. On 26-Feb-2021, Heart rate: High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications and treatment were reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment. Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: No new information was updated from follow up document.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.
63 2021-07-18 palpitations As soon as she got the shot she got immediately sick to her stomach, started itching and broke out i... Read more
As soon as she got the shot she got immediately sick to her stomach, started itching and broke out in a cold sweat. Took Benadryl when she got home and by that evening her tongue and throat started swelling, heart palpitations and couldn't breathe. Went to the ER blood pressure started going up, heart started racing and was having spasms. When released from ER started getting blisters. Went to Hospital ER.
63 2021-07-19 chest discomfort tongue change sensation, persistent nausea and heavy chest
63 2021-07-21 heart flutter Starting getting ?fluttering? heart episodes , first they started (5/3/21) about once a week. But t... Read more
Starting getting ?fluttering? heart episodes , first they started (5/3/21) about once a week. But then they gradually got worse, to the point now, where I get them every day, and sometimes several times a day. These episodes last for about 20 sec or so.
63 2021-07-22 chest discomfort After receiving the vaccine, I had a mild sore arm and a slight stomach discomfort. I had discomfort... Read more
After receiving the vaccine, I had a mild sore arm and a slight stomach discomfort. I had discomfort in the center of the chest primarily and the secondary discomfort in the belly button area. The belly becomes really bloaty, swollen, tight, sore, and uncomfortable. My ultrasound showed a lot of lumps and enlarged lymph nodes. My MRI showed primary lump in the stomach, and it showed a few lymph nodes and small tumor in the abdomen. My endoscopy showed I had a lump pushed into the stomach by 6cm. The biopsy I had also confirmed the same thing as the endoscopy. I had enlarged gastric lymph nodes. The doctors thought it was a cyst but with diagnosis the biopsy showed I had malignant endoplasmic monocytic microphage orgy. I developed a cough after I did endoscopy. The medicines I took to stop the cough did not work. My X-ray showed I have stuff in the center of my chest. My health was at it's peak before vaccine. I also noticed around my pelvic and vaginal area that my muscles are bigger and softer.
63 2021-07-25 blood pressure decreased Tongue swelling, blood pressure drop, rash. Had already left the facility where vaxed and took Benad... Read more
Tongue swelling, blood pressure drop, rash. Had already left the facility where vaxed and took Benadryl as soon as symptoms started.
63 2021-07-27 chest discomfort, palpitations, fibrin d dimer increased 1.Heart palpitation/left sitechest, squeezing 2. Chest muscle twitching 3. Left side chest pain-pres... Read more
1.Heart palpitation/left sitechest, squeezing 2. Chest muscle twitching 3. Left side chest pain-pressure 4. Hand/fingers and legs/toe tingling and numbness 5. Dizziness 6. Nausea 7. Headaches that moves into a different location 8. Terrible neck pain and throbbing 9. Weakness 10. Ankle swollen 11. Breaking skin in my mouth and a pain in mouth and troat 12. Morning coughing and swallowing (something) that extend to other hours a day 13. Dryness of the troat 14. Terrible weakness and unable to focus's to work without taking breaks every hour 15. Lost of the appetite 16. Bowel movement (concipation) 17. Less feeling of bladder emptiness
63 2021-07-27 chest pain I started to have some chest pain intermittently which was coming and going on occasion. It was unde... Read more
I started to have some chest pain intermittently which was coming and going on occasion. It was underneath my left breast. It was happening about two times a week and then it was I thought it was heart related but after testing it has been confirmed that it was not cardiac related. It has been present for six weeks and I still get the chest pain so bad that it wakes me up at night.
63 2021-07-27 deep vein blood clot DVT blood clot from the vaccine; lost 10 lbs that I can not afford to lose, 105 lbs now; Anxiety; pa... Read more
DVT blood clot from the vaccine; lost 10 lbs that I can not afford to lose, 105 lbs now; Anxiety; pain in my legs; itchy rash that went from her elbow all the way up to her shoulder from her vaccination arm; feeling nauseous; lump on the underside of her biceps; arm sore all day at the injection site and the next day she couldn't even lift it up; Arm sore at the injection site, couldn't lift up arm; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (DVT blood clot from the vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Iodine allergy. Concomitant products included CLONAZEPAM for Anxiety, CITALOPRAM and MORPHINE SULFATE (MORPHINE SULPHATE) for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm sore at the injection site, couldn't lift up arm). On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm sore all day at the injection site and the next day she couldn't even lift it up). On 25-Mar-2021, the patient experienced NODULE (lump on the underside of her biceps), RASH PRURITIC (itchy rash that went from her elbow all the way up to her shoulder from her vaccination arm) and NAUSEA (feeling nauseous). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (DVT blood clot from the vaccine) (seriousness criterion medically significant), WEIGHT DECREASED (lost 10 lbs that I can not afford to lose, 105 lbs now), ANXIETY (Anxiety) and PAIN IN EXTREMITY (pain in my legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and APIXABAN (ELIQUIS) ongoing since an unknown date for DVT, at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (DVT blood clot from the vaccine), WEIGHT DECREASED (lost 10 lbs that I can not afford to lose, 105 lbs now), ANXIETY (Anxiety), NODULE (lump on the underside of her biceps), PAIN IN EXTREMITY (arm sore all day at the injection site and the next day she couldn't even lift it up), PAIN IN EXTREMITY (pain in my legs), RASH PRURITIC (itchy rash that went from her elbow all the way up to her shoulder from her vaccination arm), VACCINATION SITE PAIN (Arm sore at the injection site, couldn't lift up arm) and NAUSEA (feeling nauseous) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication taken by the patient included steroid injection for her back. On an unknown date, the patient stated they had been to the hospital three separate times after receiving their first Moderna COVID-19 vaccine. While in the emergency room (ER) the patient suggested they do an ultrasound of the beet red, swollen, hot and itchy lump of the left arm. The ultrasound was performed and confirmed the patient had a deep vein thrombosis (DVT). It was recommended the patient had a scan of her lungs. However, the patient had an allergy to iodine and the hospital at that time did not have a machine that could perform such scan. The patient was transferred to a new hospital to have the scan performed. The unspecified scan of the lungs did not show any clots. On an unknown date, the patient reported going back to the hospital on two separate occasions for pain in the legs. An ultrasound was performed and confirmed no clots in the legs. The patient reported fear and anxiety after experiencing the DVT. This case concerns a 63-year-old female with a serious unexpected event of deep vein thrombosis, and nonserious weight decreased, anxiety, nodule, pain in extremity, rash pruritic, and vaccination site pain. Event latency within 24 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Case Upgraded to Serious. Added lab data which includes Ultrasound. Added allergy to iodine. Added new events DVT blood clot from the vaccine, weight loss and anxiety.; Sender's Comments: This case concerns a 63-year-old female with a serious unexpected event of deep vein thrombosis, and nonserious weight decreased, anxiety, nodule, pain in extremity, rash pruritic, and vaccination site pain. Event latency within 24 hours after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
63 2021-07-27 hypertension Immediately felt like I could feel it in my upper stomach area, started not feeling well. Then mout... Read more
Immediately felt like I could feel it in my upper stomach area, started not feeling well. Then mouth felt weird and a little itchy, took a teaspoon of Benadryl and it stopped. Started feeling extremely weak and head hurt severely so the nurse took blood pressure and it was 160/96 way higher than normal for me (usually 120/74). Then pain in jaw for only about 60 seconds, nurse sent me to ER. By the time I got there blood pressure was back to normal so went home slept the rest of the day and night, by morning was back to normal but stomach hurt for a couple of days, no pain in arm.
64 2021-01-03 loss of consciousness about 4 hours after vaccine, patient passed out and when came to, vomited profusely. Transferred to... Read more
about 4 hours after vaccine, patient passed out and when came to, vomited profusely. Transferred to hospital ED.
64 2021-01-06 chest discomfort fever 100.6 chills diarrhea x3 days decreased appetite x 3 days brick on chest, resolved after first... Read more
fever 100.6 chills diarrhea x3 days decreased appetite x 3 days brick on chest, resolved after first day weak sinus drainage nausea x 3 days
64 2021-01-06 chest pain Patient felt cold, lightheaded and had tingling sensation. Followed by chest pain and shortness of b... Read more
Patient felt cold, lightheaded and had tingling sensation. Followed by chest pain and shortness of breath. Patient was transferred to stretcher for monitoring. Dose of Solumedrol 125mg was given at 13:42. Dose of Benadryl was given at 13:45. Dose of Epi-pen was given at 14:06 and patient showed some improvement. Then ambulance arrived and patient was taken to hospital.
64 2021-01-06 loss of consciousness I was feeling fatigue night after injection. Next morning I passed out, woke up sweaty. Then started... Read more
I was feeling fatigue night after injection. Next morning I passed out, woke up sweaty. Then started vomiting and having severe leg cramps. Called employee health and they said to go to emergency department.
64 2021-01-06 fast heart rate Woke morning after, 1/4/21 with nausea and headache; by 10:30 a.m. body aches, chills and temp 100.3... Read more
Woke morning after, 1/4/21 with nausea and headache; by 10:30 a.m. body aches, chills and temp 100.3; Tylenol at that time; To bed at 11:30 a.m. Woke at 5pm with body aches, chills and fever 102.4; Motrin at that time; Morning of 1/5/21 temp 100 most of date with headache, body aches and fatigue; Afebrile by that evening; Morning of 1/6 woke with headache and fatigue; shortness of breath and tachycardia with exertion. Normal HR w/rest. Morning of 1/7 woke with headache that resolved w/Motrin - worked all day
64 2021-01-07 palpitations Dizziness,headache,palpitations with increased heart rate to 132/min,mild increase in BP,cold and cl... Read more
Dizziness,headache,palpitations with increased heart rate to 132/min,mild increase in BP,cold and clammy hands and both legs below knees . I didn't have any shortness of breath or chest pain. My pulse ox was 98-99.My symptoms started within 20 mins of vaccination and lasted for almost 2 hours on and off before they were resolved. I didn't need any medical intervention like O2 or IV administration of fluids or any medications. I was under observation and dranks about 30 oz of water to keep myself hydrated . Once I felt better I drove home and rested for whole day and didn't go out. I didnt have any recurrence of these symptoms later that day or next day.
64 2021-01-07 fast heart rate, hypertension within about 10 minutes I felt terrible, hot, flushed, tachycardic, and developed significant hives ... Read more
within about 10 minutes I felt terrible, hot, flushed, tachycardic, and developed significant hives on my face and neck and swelling around my eyes. I was taken to a room and had vitals and was hypertensive and tachycardic with a worsening headache, I was given 50 mg Benadryl and put ice on my face and neck for about 20 minutes as I felt I was burning up. I remained at the clinic for an hour for monitoring. I never had difficulty breathing , and it was mostly resolved in about 45 minutes except for the mild headache and my face was still red and my eyes were swollen for at least an hour.
64 2021-01-08 blood pressure increased, fast heart rate, heart rate increased About 3 minutes after receiving exam went to sit down to wait for 15 minutes. A flush came over my b... Read more
About 3 minutes after receiving exam went to sit down to wait for 15 minutes. A flush came over my body and I felt myself becoming tachycardic. I spoke to the nurse who hooked me up to bp machine. O2 sat was fine at 98. BP was 158/110, pulse rate was 157. Normal values for me are bp 120/70, pulse 80. BP started to go down and several minutes later another flush happened and bp and pulse rate went back up. Dropped again then third flush with increased bp and pulse happened. After this vitals went back to normal and didn't happen again. I subsequently developed a pounding headache which lasted until the next morning. Arm was sore as expected. BP that night was normal and the next morning normal. No further adverse effects noted other than fatigue.
64 2021-01-08 pallor Client felt dizzy + lightheaded, hot flash. Became pale + diaphoRetic. Reported feeling anxious abou... Read more
Client felt dizzy + lightheaded, hot flash. Became pale + diaphoRetic. Reported feeling anxious about COVID, the vaccine, potential side effects, everything. Patient was in post vaccine holding area being monitored by an RN for mandatory 15 minute wait time. Was able to ambulate w/assist to treatment area. Placed in Room w/RN. Placed supine on bed. BP 136/85 HR 71 Regular, Resp 18 Regular. Pt pale, talkative. Given apple jc on Request. Tol. well. Slowly returned to normal skin color. Symptoms Resolved.
64 2021-01-09 palpitations Heart palpitations around 9:30 pm and again around 11:30 pm, fatigue lasting 2days, slight upset sto... Read more
Heart palpitations around 9:30 pm and again around 11:30 pm, fatigue lasting 2days, slight upset stomach, and dull headache for 2days
64 2021-01-10 chest discomfort 1 hour after vaccine developed HA, 6 hours after vaccine Chills, fever, nausea, dry heaves, weakness... Read more
1 hour after vaccine developed HA, 6 hours after vaccine Chills, fever, nausea, dry heaves, weakness, dizziness, chest tightness
64 2021-01-10 pallor blanchable erythematous pruritic rash to back, chest, abdomen occurring 1 week after vaccine and las... Read more
blanchable erythematous pruritic rash to back, chest, abdomen occurring 1 week after vaccine and lasting a week at time of visit. Looks like hives but does not come and go. No resp concerns.
64 2021-01-11 chest discomfort, palpitations Within several minutes after injection, I felt flushed, strange feeling in head and chest as if I wa... Read more
Within several minutes after injection, I felt flushed, strange feeling in head and chest as if I was going to pass out, and heart started pounding. These symptoms subsided within 2 minutes with no treatment needed. I sat for 15 more minutes with no further problems.
64 2021-01-12 chest discomfort She reported a headache. and pressure to the L side of her neck and chest. BP 136/105. Patient waite... Read more
She reported a headache. and pressure to the L side of her neck and chest. BP 136/105. Patient waited for 30 minutes and bp was 141/83. At that time she only reported having a headache. She declined to go to the medical clinic for evaluation. She said she would go home and take an aspirin. If symptoms worsened, she would go to the ER.
64 2021-01-12 nosebleed The day of vac 1/8/2021 at 5:00pm got a bloody nose about 6:00pm the chills went to bed about... Read more
The day of vac 1/8/2021 at 5:00pm got a bloody nose about 6:00pm the chills went to bed about 9 pm with mild headache. No arm pain 1/9/2021 sat night at 1:30 am nose bleed 1/10/2021 3:00 pm another nose bleed All events held pressure..I can't tell you the last time I had a nose bleed!
64 2021-01-12 heart rate increased I had a Covid test on the 1/4/21 thinking I might have covid. I am negative. So concerned had a 1/... Read more
I had a Covid test on the 1/4/21 thinking I might have covid. I am negative. So concerned had a 1/12/21 EKG all was fine. I have had shortness of breath and very rapid heart beat. I had a bruise on my right arm the size of a desert plate. It is finally gone after 12 days. I never bruise from any kind of an injection, My blood pressure was up. 135/80 . I am usually 106/68.. 1/12/21 Had temp 99. On the 9th day.. Very tired slept the day away. I am a person that requires about 6 hrs a night I am fine. My pulse had been around 88 it is usually 68-70. Oxygen is 98.
64 2021-01-13 blood pressure fluctuation Due to lack of data for Asian-descent - I hope this data is helpful to Moderna and CDC. Light advers... Read more
Due to lack of data for Asian-descent - I hope this data is helpful to Moderna and CDC. Light adverse side effects right after the vaccine was administered. Remained under supervision for 45 minutes longer instead of 15 min. Within 5 mins, heat rose up to my head causing dizziness & head spin. Then loss of smell lasting for 10 min or a bit longer, then tongue tied hard / swollen for 3 hrs and lasting mildly 1 day after. Severe dehydration. Did not monitor heart beat due to severe fatigue. Took blood pressure rising and falling like roller coaster 2x. I stop and learned to relax and sleep throughout the day to calm the nervous system and the slight fever. Other normal aching pains as pre-described side effects. No nausea, vomiting, no rash as of 1 day after and no difficult breathing. Occasional and short loss of smell carried after 1st day.
64 2021-01-13 heart rate irregular fever, chills, muscle aches, irregular heart rate
64 2021-01-17 fainting On 01/14/2021 patient experienced severe chills and shaking upon awakening. She subsequently vomited... Read more
On 01/14/2021 patient experienced severe chills and shaking upon awakening. She subsequently vomited three times following the episode of chills and shaking. Later in the day the client experienced two episodes either extreme fatigue or fainting - she is unsure of the nature of the events since she does not recall falling asleep, and both events occurred in her vehicle while parked.
64 2021-01-17 fainting 1/6/21 HA, severe leg cramps, N/V, fatigue, syncope
64 2021-01-18 chest discomfort Pressing on chest causing shortness of breath; extreme fatigue; stomach discomfort; nausea, headache... Read more
Pressing on chest causing shortness of breath; extreme fatigue; stomach discomfort; nausea, headaches, no appetite; chills; diarrhea, 2 days later false positive for Covid. Three days later for next 4 days, tested negative each time for Covid. Since vaccine 1 to 3 weeks later fatigue, no appetite, suicidal thoughts as if my endorphins were temporarily deleted but endorphins returned 24 hours later. Due to the extreme side affects, 1/22/21, I will not receive my 2nd Moderna vaccine.
64 2021-01-18 heart rate increased, hypertension Severe Joint and Muscle Pain, Vomiting, Fever, Severe Pain in Middle of Back, Severe Sore Right Arm ... Read more
Severe Joint and Muscle Pain, Vomiting, Fever, Severe Pain in Middle of Back, Severe Sore Right Arm ite of Injection. Severe High Blood Pressure , Rapid Heart Rate,
64 2021-01-19 palpitations Approximately 10 minutes after receiving 2nd dose of Moderna vaccine, pt c/o flushing, dizziness, he... Read more
Approximately 10 minutes after receiving 2nd dose of Moderna vaccine, pt c/o flushing, dizziness, heart "racing", and itchiness to left hand; VS taken; physician notified.
64 2021-01-19 palpitations Lip tingling 5 minutes after injection Metallic taste and headache 8 hours after vaccine: increase i... Read more
Lip tingling 5 minutes after injection Metallic taste and headache 8 hours after vaccine: increase in lips tingling, peri-orbital tingling, throat itching, burning, roof of mouth burning, decreased swallow sensation, heart palpitations, fatigue 1/13 Fatigue, weakness, decreased swallow sensation, phone call with physician 1/14 Fatigue, weak, decreased swallow sensation, heart palpitations 1/15 Diarrhea, weakness, fatigue, decreased swallow sensation, phone call with physician's office 1/16-1/18 Weakness, fatigue, decreased swallow sensation
64 2021-01-19 palpitations Moderna COVID-19 Vaccine EUA At about 8 pm the day following my vaccination; I started to experience... Read more
Moderna COVID-19 Vaccine EUA At about 8 pm the day following my vaccination; I started to experience sharp needle-like pain at the site of injection (left arm). It was brief. Immediately following that pain, the fingers on my left hand went numb and I couldn't feel them -- particularly my pinky and ring fingers. I could move my fingers but they were numb. I did not have a fever. This lasted about 2 hours. I iced the site of injection, kept my hand above my shoulder and massaged my fingers for the duration (about 2 hours). When this first occurred my heart was racing -- but that might have been because it scared me. I feel fine today.
64 2021-01-20 blood glucose increased The day after my first shot, my blood sugars went crazy. Elevated up over 200-275 most of the day. ... Read more
The day after my first shot, my blood sugars went crazy. Elevated up over 200-275 most of the day. Tried to adjust with more insulin, and could not get them to decrease and stay in range. My A1cs are usually between 6.6 and 6.8 and I stay in my target range 85-90% of the time. It has now been two weeks since my shot, and the numbers are still elevated. Is this a normal reaction to the vaccine, and will my second shot be worse? How long can I expect this to last? Have consulted with my diabetes educator at my endocrinologist's office...can't seem to find solution. She is thinking that the vaccine creates inflammation which would elevate the sugars, but after two weeks, it should be improving. Am worried about 2nd shot.
64 2021-01-20 chest discomfort, palpitations felt very dizzy, tightness of chest and stiffnes of neck, palpitations, cold extremities. constant u... Read more
felt very dizzy, tightness of chest and stiffnes of neck, palpitations, cold extremities. constant urination and bowel movements during attack.
64 2021-01-21 palpitations On Saturday on the 16th I started itching all over my body and my head, dry mouth and my ears were i... Read more
On Saturday on the 16th I started itching all over my body and my head, dry mouth and my ears were itching as well. On Sunday I noticed the itching increased after taking my levothyroxine. The 18th I noticed the same pattern of itching increasing after taking the levothyroxine the dry mouth as continued. Have not been sleeping well. The 19th same pattern occurred. I also developed a slight headache. I have been using lots of lotion. The itching appears to worsens after taking the Levothyroxine and after showering. The 20th same thing, but the headache was worse so I took two aspirins. The 21st was a big change, my heart was racing the normal pattern but at 1pm in the afternoon while walking home I noticed a burning sensation on my rear-end. When I made it home I noticed an elongated redden area it was very red and I put some cream triple antibiotic cream on there. It was burning very badly. The evening I went back to work my body started itching again, I noticed the area where I received the vaccine was red and hard under the skin about 3inch diameter area. Took a shower and put antibiotic cream. Today after taking my pill in the morning itching came back, and the redden area at the injection site looks like hives now . The redden area on my bottom has improved. My heart was also racing again. I did called the hospital last night and was supposed to receive a return call which I have not received yet.
64 2021-01-22 heart rate increased Swollen lips, numb/tingling lips and tongue, rapid heartbeat - later sore arm
64 2021-01-22 lightheadedness Went to work around 10AM left with chills. Driving home needed to pull over because was beginning to... Read more
Went to work around 10AM left with chills. Driving home needed to pull over because was beginning to pass out. Barely made it off road. Open windows to car place head down and remained in car for 30-40 mins. Then drove home slowly. Arrived home with severe chills , temp 101 and headache. Medicated self with Tylenol. Rest of night continued with chills and headache along with aching all over as the night to day continued. Called into work sick next day chills , headache and aching all over. Temp lower to 99. Went out today and still got faint and came home.
64 2021-01-25 blood pressure increased By 5 in afternoon I had a fever. Headache and chills. Took tylenol to bring fever down and rest. Nex... Read more
By 5 in afternoon I had a fever. Headache and chills. Took tylenol to bring fever down and rest. Next day increased blood pressure, foggy, confused, aches, increased temp and fatigue. Fever continued until 1/24. Increased blood pressure until 1/26. 12/25 went to DR office. given z pack. Head ache, fatigue, and some foggy/confusion continues. Continue to drink fluids and rest. 1/26 went to DR walk in clinic to get covid testing per DR order. Fast test came back negative so they took another sample to send out to lab.
64 2021-01-25 heart rate increased 40 minutes after receiving vaccine had severe warmth and intense redness to the face and scalp with ... Read more
40 minutes after receiving vaccine had severe warmth and intense redness to the face and scalp with increased heart rate. Returned to clinic immediately. Vital signs monitored and suggested transport to ER. Family member drove me to ED. Treated in ED and received IV push Prednisone and Benadryl. Discharged 3 hours after being treated in ER. Severe redness subsided after receiving Benadryl and Prednisone.
64 2021-01-26 chest discomfort complain of tightness in center of chest. no wheezing, no cough. EMS called. going to hospital.
64 2021-01-26 chest pain Developed Left sternal chest pain with radiation to L upper arm with numbness and tingling of 3 fing... Read more
Developed Left sternal chest pain with radiation to L upper arm with numbness and tingling of 3 fingers on left hand (Vaccine was administered in Right arm). Presented to ER, EKG showed inferior lead changes suggestive of ischemia. Was admitted overnight onto telemetry floor, no adverse s/s noted. Labs normal. CXR normal. Discharged next day, 1/23/21, with recommendation for cardiology follow up. Stress test, echo, and potentially cardiac MRI recommended, awaiting scheduling. Cardiology follow up scheduled Mon, 2/1/21.
64 2021-01-27 heart rate increased Fever 101. High pulse 120. Body aches. Chills. Lasted 24 hours
64 2021-01-28 oxygen saturation decreased Patient stated that she felt nauseated after her 15 min. observation check and vitals were taken. P... Read more
Patient stated that she felt nauseated after her 15 min. observation check and vitals were taken. Patient was given oxygen and some water. Patients oxygen were low @ 78 when vitals were completed, but after the oxygen was administered they went up to 98. Patient was observed for 15 more minutes and then stated that she felt fine. Patient was called this evening @ 5:30pm and she stated that she feels fine and was home relaxing.
64 2021-01-29 palpitations Severe weakness, palpitations, shortness of breath, body aches, faintness
64 2021-01-30 palpitations States experienced palpitations, fever of 103 degrees, chills, nausea, & weakness about 12hrs after ... Read more
States experienced palpitations, fever of 103 degrees, chills, nausea, & weakness about 12hrs after receiving vaccine. Took Ibuprofen and symptoms resolved the next morning. Was not evaluated in the ED. Feeling "much better" today.
64 2021-01-31 blood pressure decreased, blood pressure increased About 6 minutes after the vaccination I begin to experience throbbing pain in the base of the right ... Read more
About 6 minutes after the vaccination I begin to experience throbbing pain in the base of the right side of my neck. I sat back and pushed my head back to see if it would stop but it didnt. 5 minutes after that pain begin radiating up and down my right leg from the thigh to mid calf. I was checked and monitored for about 15 minutes then my mouth got really dry but even with water it was still very very dry. After my mouth was still really dry and the pain continued to radiate I was sent to the urgent care and advised to walk around, so the nurse assisted me in walking around the urgent care. I was able to walk but was wobbly and after some time the NP assessed me. I was given an icepack to put on the base of my neck. My BP raised and I begin to have a high pitch noise ringing sensation in my ear, sore throat and it felt as if I just needed to keep drinking because my mouth still felt really dry. I was recline back and my legs were elevated to try to help lower my BP. And after about 20 minutes my BP lowered and I was continued to be monitored. I was advised they would not give me any steroids because it would counteract the vaccine but was given a shot of torodol and benedryl to help with the pain. I had body aches and my arm at the injection site was sore as well. I was monitored for another 30-45 minutes long and was released and was taken off work for the remainder of the day and rested. The next day the leg pain was gone but the dry mouth, body aches and the fatigue was still there for about another week.
64 2021-01-31 platelet count decreased Pt. presented to the ER with abd pain and septic shock. Pt. reported to feel ill shortly after rec... Read more
Pt. presented to the ER with abd pain and septic shock. Pt. reported to feel ill shortly after receiving the vaccine.
64 2021-02-01 platelet count decreased Jan. 28, I'm fine, just some bearable site pain. Took tylenol before getting vaccine, and the next d... Read more
Jan. 28, I'm fine, just some bearable site pain. Took tylenol before getting vaccine, and the next day around 4 in the morning started having malaise, pain, fever, chills. (fever around 102), and went 104 around midafternoon, and 106 around 10. Chills, pain, weakness. Next day I was feeling well. I started noticing small dots on knee and shoulder. And then I started noticing bruising on my hands and legs. Felt fine on Sunday. I started noticing the bruises were becoming more pronounced. On Monday when I woke up the bruises were worse, and I went to the ER. The doctor checked CBC and platelets count was low around 28 thousand and was admitted into the hospital and they treated me with solumedrol 100 mg. Platelets count went back up.
64 2021-02-02 nosebleed, hypertension On 12/29/2021 as soon as I woke up I could not get out of bed, I had a fever of 101 or higher, a ter... Read more
On 12/29/2021 as soon as I woke up I could not get out of bed, I had a fever of 101 or higher, a terrible headache, my nose bleed, a dry non productive cough, also my blood pressure was very high it was around the 170s & 180s at that time. The next morning 12/30/2021 I still had a headache but not as bad as the 29th, no fevers on the 30th. I still had nose bleed but very little. The cough still continued & my high blood pressure still continued the lowest it got 144 over79. I experienced moments of weakness & that's when my blood pressure would shoot up. I called my doctor on the 12/30/2021 I called my doctor and he started me on medications & he told me to keep track of my blood pressure. On 12/31/2021 everything began to diminish except the blood pressure that one continued. The high blood pressure continued all the way towards the end of January. On 01/28/2021 I ended up in the emergency room also because of my blood pressure & they did some test there.
64 2021-02-04 loss of consciousness, fainting, fast heart rate 12 hr post - chills and fatigue, 24 hrs - fatigue, generalized aches preceded syncopal event while ... Read more
12 hr post - chills and fatigue, 24 hrs - fatigue, generalized aches preceded syncopal event while seated with sweating , blurred vision then loss on consciousness for 15 seconds. Revived on floor with tachycardia, sweating then nausea and vomiting x 1.
64 2021-02-05 heart rate irregular Headache, Chills, 101 fever, weakness, muscle aches, intense burning sensation in both arms, nausea,... Read more
Headache, Chills, 101 fever, weakness, muscle aches, intense burning sensation in both arms, nausea, shortness of breath for 48 hours. One incident of irregular pulse that lasted 45 minutes .
64 2021-02-06 palpitations, fast heart rate Fever (100.6), Chills, Sever headache, body aches, fatigue, tachycardia. All except tachycardia ende... Read more
Fever (100.6), Chills, Sever headache, body aches, fatigue, tachycardia. All except tachycardia ended by afternoon of 2/5. Tachycardia ongoing. Heart rate raises to ~108 with a mere walk down the hallway of my house.
64 2021-02-07 blood pressure increased Tongue became very dry, felt faint first few minutes, but thought i was nervous , left facility afte... Read more
Tongue became very dry, felt faint first few minutes, but thought i was nervous , left facility after waiting 20 minutes, At home after one hour lips began to swell , I then went back to Hospital was admitted to ER , 50 mg Benadryl administered and I was monitored for several hours until lips began to return to normal
64 2021-02-07 chest pain Arm was red from shoulder down to crease of elbow & warm to touch. Chest pains come and go.
64 2021-02-07 heart rate increased, hypertension After second dose, I felt okay until the next day at 3:00 pm I started feeling flu-like symptoms; ex... Read more
After second dose, I felt okay until the next day at 3:00 pm I started feeling flu-like symptoms; extremely fatigued. I was thirsty. I had a little bit of high blood pressure and high heart rate but medicine kept that in check and it's better now. Arm super sore in the muscle where they injected and up to my armpit. I have a follow up appt on the 12th and my doctor will re-exam me. I still havedifficult time going to sleep and with waking up early. I am still on the new med from the first dose.
64 2021-02-07 palpitations, hypertension I had extremely high blood pressure; my heart was throbbing. I was told to go to ER at work but I di... Read more
I had extremely high blood pressure; my heart was throbbing. I was told to go to ER at work but I didn't and went home and rested. That went on for days. I called my doctor and she put me on Metrozal to help with heart rate and BP and that brought that back down again. I'm taking this every day now in addition to my other blood pressure medicine. It has helped. I had headaches; I had terrible dreams and couldn't sleep. My eyes turned all dark - like when you need to drink water (underneath eyes). Had a terrible thirst. I drink water constantly. I had bruising on various parts of my body - legs; arms etc. It's calmed down with all these symptoms within a couple of weeks.
64 2021-02-07 fast heart rate Symptoms started about 12 hours later and included: brief dizziness, tachycardia (100 bom), headache... Read more
Symptoms started about 12 hours later and included: brief dizziness, tachycardia (100 bom), headache, low grade temperate (98.8 F), sweating out my back/neck and from my face (face was HOT), body aches, arm swollen, hard and pink/red (still 4 days later!), and lichen sclerosus flare requiring use of clobetesol.
64 2021-02-08 blood pressure increased, very slow heart rate Narrative: Patient admitted to the hospital 2/7/21 following episode of nausea/vomiting, elevated b... Read more
Narrative: Patient admitted to the hospital 2/7/21 following episode of nausea/vomiting, elevated blood pressure, bradycardia, elevated lactate, fever, and leukocytosis. Patient treated with intravenous fluids and started on intravenous antibiotics. CT of the abdomen on 2/8/21 identifies mild acute diverticulitis.
64 2021-02-08 hypertension, heart rate increased swelling, body aches, sweating, rapid heart beat, high blood pressure
64 2021-02-08 pulmonary embolism, deep vein blood clot Deep vein thrombosis; pulmonary embolism; A spontaneous report was received from a 64-year-old femal... Read more
Deep vein thrombosis; pulmonary embolism; A spontaneous report was received from a 64-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed deep vein thrombosis and pulmonary emboli. The patient's medical history was not provided. Concomitant product use was not provided. On 05 Jan 2021, approximately 3 weeks prior to the onset of the events, the patient received first dose of mRNA-1273 (Lot number: 037K20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient reported she was hospitalized for deep vein thrombosis and pulmonary emboli. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, deep vein thrombosis and pulmonary emboli, were considered unknown.; Reporter's Comments: This case concerns a 64-year-old, female patient. The patient's medical history was not provided. The patient experienced serious, unexpected event of Deep vein thrombosis and pulmonary embolism. The events occurred 22 days after the first dose of mRNA-1273 (Lot number: 037K20A) administration. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested for further assessment.
64 2021-02-09 skin turning blue 1/26/21 - at 9pm (9hrs after vaccine) he toes, feet and ankles turned "blue" with slight tingling an... Read more
1/26/21 - at 9pm (9hrs after vaccine) he toes, feet and ankles turned "blue" with slight tingling and numbness. The "blue" crept up to her knees at 10pm. Denied pain or tenderness. 1/27/21 - She call public health to report her legs below the knees have been "blue" with slight swelling, tingling and numbness. The tingling is relieved by standing and walking. Denies pain or tenderness. Advised to see her healthcare provider. She sent the health department pictures showing ecchymosis on the lateral side of her ankles and calves. 1/28/21 - TC to patient, she made a doctor's appointment yesterday then canceled it because the "blue" or ecchymosis was better. Denied pain, tenderness, swelling, numbness or tingling.
64 2021-02-09 hypertension Moderna COVID-19 vaccine EUA About 10 hrs after receiving vaccine (2nd dose) I became very anxious/... Read more
Moderna COVID-19 vaccine EUA About 10 hrs after receiving vaccine (2nd dose) I became very anxious/ jittery I took my BP and it was extremely high 194/ 92 ( normal pressure for me averages 118/ 70. Went to bed and tried to relax and rest. Did not see anyone other then telling spouse. (I am a nurse)
64 2021-02-10 chest discomfort Received Covid vaccine at school setting. 10 min after vaccine- client stated felt tightness in back... Read more
Received Covid vaccine at school setting. 10 min after vaccine- client stated felt tightness in back and chest and it felt hot there -kind of like hot flash but different. Also got upset stomach and little light headed. A co-worker (teacher ) took her pulse and it was 66. Lasted for about an hour and then felt better. She notified public health by phone after 30 min and was recommended she call her healthcare provider. Called her back 30 min after that (about hour and 10 min after vaccine) and she had not called provider and was feeling much better. Denies having problems with any shots in the past
64 2021-02-10 lightheadedness HPI: reports feeling ?woozy? 30 minutes after getting Moderna COVID-19 vaccine, 2nd dose in series. ... Read more
HPI: reports feeling ?woozy? 30 minutes after getting Moderna COVID-19 vaccine, 2nd dose in series. Reports she became lightheaded when she stood up to leave. No syncope. No chest pain or SOB. No airway complaint. No headache. Reports she did not eat breakfast or lunch. PMH: HTN Allergies: tree nuts, some fruits, latex Meds: triamterene/hctz 37.5/25mg, Epipen as needed ROS: otherwise negative. PE: Constitutional: No acute distress. Able to sit in a chair without difficulty. Skin w/d. Respiratory: No increased WOB. Cardiac: radial pulses strong and regular. A/P: Lightheaded. Likely secondary to not eating any meals today and then receiving IM injection, mild vasovagal response. No allergic reaction evident. Given graham crackers and juice, which she ate without difficulty. Felt completely fine within 10 minutes and preferred to leave in order to attend a meeting. Encouraged to seek attention for new or worsening. Will report.
64 2021-02-11 palpitations c//o Heart racing. B/P 172/102; Pt instructed to continue to self monitor and if symptoms worsen or... Read more
c//o Heart racing. B/P 172/102; Pt instructed to continue to self monitor and if symptoms worsen or new symptoms develop seek emergency attention. Pt instructed to seek medical advise for second dose. If second dose recommended patient may not use the Drive thru locations and must get vaccination at doctor's office for more controlled environment.
64 2021-02-13 fainting Fever, Headaches, nausea, bodyache. Became very weak, fainted and fell on the floor. lost all her me... Read more
Fever, Headaches, nausea, bodyache. Became very weak, fainted and fell on the floor. lost all her memory about the incident.
64 2021-02-14 heart rate increased, chest discomfort Sudden onset 2 episodes rapid heart rate - 5-10 seconds. Ongoing mild chest pressure with and with... Read more
Sudden onset 2 episodes rapid heart rate - 5-10 seconds. Ongoing mild chest pressure with and without exertion multiple times every day since. Two days - January 28 and Feb 13 - of severe malaise. Also, Feb 13, episodes of erratic heart rate between 7 - 9 pm - spontaneously resolved.
64 2021-02-15 blood pressure increased Severe blood pressure elevation post vaccine days 1&2
64 2021-02-16 atrial fibrillation, heart rate increased Moderna vaccine #1. High heart rate and atrial fibrillation reported by Watch over three day period ... Read more
Moderna vaccine #1. High heart rate and atrial fibrillation reported by Watch over three day period beginning about 3 hours + after injection. . Resting heart rate was up to 167 at one time and sleeping rate was up and down in the low 100?s Did several ECGs and atrial fibrillation reported several times. Heart rate began to subside after a full two days with spikes. Monitored through weekend to be sure no further spikes. Have copies of reports. Called and reported to physician on 2/16. Called VARES and Moderna to report and no return calls as yet as no choice but to leave voice mail.
64 2021-02-16 loss of consciousness Passed out twice, for a few seconds each time, during trip to bathroom in attempt to vomit. Nausea, ... Read more
Passed out twice, for a few seconds each time, during trip to bathroom in attempt to vomit. Nausea, low grade fever, cold sweats following. Did not vomit. Arm soreness at site, other muscle soreness, headache, fatigue continued for six hours. Symptoms lessened and continued for 24 hours at lesser extent.
64 2021-02-16 low platelet count Platelet count of 28,000; Generalized body pain all over; Weakness; On and off Chills; Low grade fev... Read more
Platelet count of 28,000; Generalized body pain all over; Weakness; On and off Chills; Low grade fever; Injection site soreness; A spontaneous report was received from a consumer who was a 64-year-old, female patient who developed a platelet count of 28,000 (thrombocytopenia), generalized body pain all over (general body pain), weakness (asthenia), on and off chills (chills), low grade fever (pyrexia), and vaccination site soreness (injection site pain). The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (lot number 039K20A) on 31 Dec 2020. On 28 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (lot number 209K20A) in the left arm for prophylaxis of COVID-19 infection. On an undisclosed date the patient experienced injection site soreness, generalized body pain all over, chills, low grade fever and weakness. She also went to the hospital because she had a platelet count of 28,000. Treatment of these events was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable. The outcome of the events, platelet count of 28,000, generalized body pain all over, weakness, on and off chills, low grade fever, and vaccination site soreness, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
64 2021-02-17 palpitations, heart rate increased Rapid Heart rate , Heart palpitations within 15 minutes of receiving vaccine. Pulse 122. when ch... Read more
Rapid Heart rate , Heart palpitations within 15 minutes of receiving vaccine. Pulse 122. when checked by EMT. Waited half hour longer went home. About 4 hours later went to . ER B/p 204/104 Pulse 108 at check in.
64 2021-02-18 blood pressure increased, chest discomfort Three weeks after vaccine patient experienced Headache, Fatigue, nausea, chest pressure, deep, cough... Read more
Three weeks after vaccine patient experienced Headache, Fatigue, nausea, chest pressure, deep, cough. WAs hospitalized 2/3/-2/4 for elevated blood pressure on observation. took next week off to regulate blood pressure. Saw PCP on 2/10 and was released for work on 2/15. Dr., hospitalist at Medical Center, .
64 2021-02-18 hypertension, palpitations Minutes after receiving the injection I felt a horrible taste in my mouth. I asked the woman who was... Read more
Minutes after receiving the injection I felt a horrible taste in my mouth. I asked the woman who was scheduling my next vaccine if this was normal. Then began feeling dizzy, nauseous and heart was racing and felt flush in my face. They sent 2 EMS people to take my blood pressure; i actually don't remember what it was because i felt a bit disoriented. The man EMS person said the BP was high and asked me to wait. They came back 15 minutes later and took it again and it went down but I still felt my heart racing and nauseous. I waited for a half hour then called a car service to take me home. I felt extremely tired achey, and head ache for 3 and 1/2 days. The foul tase in my mouth lasted about 4 days. I spent most of the 3 days just resting. I felt back to normal after day 5 but feeling very apprehensive about getting my second dose.
64 2021-02-20 loss of consciousness 2/18/21 time around 9pm, sore arm along with red rash, still remains today but better. Had this rea... Read more
2/18/21 time around 9pm, sore arm along with red rash, still remains today but better. Had this reaction 1st vaccine 1/18/21 Moderna Lot #011620A. 2/19/21 body soreness, hands hurt, general not feeling well. 2/20/21 Awake at 2:00 am fever, dizziness, unable to walk straight and passed out. Slight temp w/tingling and numbness in both arms from mid shoulder to fingertips. Vison blurred and wavy. Rested all day. Today, 2/21/21 felt better at 8:00, vision better and tingling & numbness gone in arms. Foggy head, unable to focus on numbers. Resting but having to do chores for work week tomorrow. Vision still not 100%.
64 2021-02-21 blood glucose increased Elevated blood sugars into the 300's. Started next day and have persisted for 4 days requiring me to... Read more
Elevated blood sugars into the 300's. Started next day and have persisted for 4 days requiring me to contact my physician.
64 2021-02-21 hypotension Per ED note: Brought in ED by EMS at 1945 for acute shortness of breath and hypotension. Patient was... Read more
Per ED note: Brought in ED by EMS at 1945 for acute shortness of breath and hypotension. Patient was placed on supplemental oxygen and covid test completed. Patient was placed on BiPAP to maintain oxygen greater than 90%. Found to be in metabolic acidosis. Patient became unresponsive and pulse could not be palpated. Chest compressions were initiated. ACLS medications given and pulses regained. Patient lost pulse 30 mins later and never regained pulse. Per ED noted; likely developed a PE. Passed away at 2127
64 2021-02-22 low blood oxigenation, chest pain, fast heart rate, fibrin d dimer increased, coughing up blood, hypotension 2/14: The day after receiving the vaccine, she noticed a rash on her chest and legs. She felt nauseo... Read more
2/14: The day after receiving the vaccine, she noticed a rash on her chest and legs. She felt nauseous and endorsed vomiting, body aches, and fever. 2/16: Saw PCP and was found hypotensive. Was sent to ED and received 2L fluids, IM steroids, and PO ondansetron. She was discharged because she was feeling better. 2/17: Returned to hospital due to pleuritic chest pain and hemoptysis and was noted to have an elevated lactate (received 3L fluids) and was admitted to the hospital. SpO2 was in the 70s on presentation and she was placed on BiPAP (O2 improved to 100%). Per note: patient presented to the ED with hypoxia, tachycardia, tachypnea, and leukocytosis. Patient received dexamethasone 6mg, vancomycin, cefepime, azithromycin, furosemide, and ipratropium/albuterol. Patient is currently receiving the following medications: budesonide, ipratropium/albuterol, cefepime, acetaminophen, atorvastatin, benzonatate, enoxaparin, escitalopram, ferrous sulfate, guaifenesin, hydrocodone/acetaminophen, methylprednisolone, methylprednisolone, Montelukast, morphine, ondansetron, pantoprazole. Patient has been hospitalized since 2/17
64 2021-02-23 palpitations, heart rate increased 64 YEAR OLD FEMALE HAS A HISTORY OF A-FIB. ABOUT 15 MINUTES AFTER RECEIVINE VACCINE, SHE FELT HER HE... Read more
64 YEAR OLD FEMALE HAS A HISTORY OF A-FIB. ABOUT 15 MINUTES AFTER RECEIVINE VACCINE, SHE FELT HER HEART RACE. ON SITE EMS RESPONDED. THIS WAS HER FIRST VACCINE, EVER. HER INITIAL HR WAS IN THE 140'S IT IMPROVED TO 82 OVER TIME. OTHER FINAL VITALS BELOW. EMS RAN SEVERAL EKG'S. THEY APPEARED NORMAL. IT WAS RECOMMENDED TO GO TO THE ER, BUT SHE REFUSED.
64 2021-02-24 blood pressure increased Patient complained of mild headache 15 minutes after injection and mild dizziness. 30 minutes after ... Read more
Patient complained of mild headache 15 minutes after injection and mild dizziness. 30 minutes after injection complained of right face numbness, right ear and right neck pain. Evaluated 1 hour later and denied symptoms
64 2021-02-24 chest discomfort Patient states that she was not feeling right, stated could have been blood pressure, blood pressure... Read more
Patient states that she was not feeling right, stated could have been blood pressure, blood pressure was with in normal limits, patient stated that she was having shortness of breath and chest tightness, offered to call ems client refused stated that she had family here with her and that she would have them take her to the ER advised against offered to call ems again client still refused and left with family in private vehicle .
64 2021-02-25 chest discomfort The same day I received the vaccine, some hours later I started feeling like a pressure in my head. ... Read more
The same day I received the vaccine, some hours later I started feeling like a pressure in my head. It was not a headache, it was a pressure. It made me dizzy. I also experienced extreme fatigue and so much that it was hard to walk. Really hard to just get out of the bed. Like my legs did not want to move. I had to literally mover them from the bed. Cough. My doctor said after I had covid in June 2020 that my lungs were damaged and now they just work on a 61% capacity. I also felt like my lungs were burning. When I am able to have a productive cough and get rid of some phlegm, then I feel better, I can really breathe and feel like clean air in my lungs. But lots of times I just cough and nothing comes out and then it gives me a sensation that my chest is tight. Still, every morning I cough, just like this morning and my chest feel tight.
64 2021-02-25 oxygen saturation decreased, bleeding on surface of brain, low blood oxigenation, stroke, excessive bleeding Moderna COVID-19 Vaccine EUA adverse event. Approximately 7 hours after the 1st COVID vaccination ... Read more
Moderna COVID-19 Vaccine EUA adverse event. Approximately 7 hours after the 1st COVID vaccination on 2/22/2021, patient developed symptoms of fatigue, aches, chills & fever. Her symptoms worsened into 2/23/21 with increasing shortness of breath. On arrival in the emergency center on 2/23/21, she was hypoxic with SpO2 81% on room air. Oxygen supplement via nasal cannula was given which improved her oxygenation. Covid 19 test negative. Chest Xray shows pulmonary edema and CTA chest shows no PE. She was admitted to the hospital and provided supportive care. Pulmonary Edema and inflammatory process is likely associated with the vaccine. Patient appeared to be improving, however, on 2/26/21, she was working with Physical Therapy/Occupational Therapy and had a pulse ox reading of 75% on room air. She was on 10 Liters of oxygen via nasal cannula by the time she make it back to bed and her pulse ox was 89%. Neurology exam shortly afterward the above event demonstrated an NIHSS of 21. Patient became non-verbal and stat imaging revealed an acute hemorrhage in the left occipatal lobe likely representing a SAH. Patient then transferred to another hospital that could provide neurosurgical intervention.
64 2021-02-28 palpitations 65 years old female felt chest palpitations. Onsite Ems responded Vitals BP 161/103 HR 93. We gave h... Read more
65 years old female felt chest palpitations. Onsite Ems responded Vitals BP 161/103 HR 93. We gave herba few minutes to relax. She felt better & released to home, she did say she hadn't eaten yet.
64 2021-03-01 heart rate increased 1524- whole body shakey, HR-140's, feels anxious, 02 sat 99%RA, b/p 172/98. Within 10 min of vaccine... Read more
1524- whole body shakey, HR-140's, feels anxious, 02 sat 99%RA, b/p 172/98. Within 10 min of vaccine she states heart started beating fast, felt warm ,warmness went away. 1532 cont shakey Hr-114, 1541 repeat little dizzy and shakiness increased, b/p 158/82, hr-119, 02 sat 99%. 1550-Pt reports she is starting to feel better hr-107, 02 sat 98% ra. 1600 reports head clear now, no dizziness, HR-95, 0s sat 98%ra, 1615 b/p 148/80, hr-95, 02 sat 100%. Pt notified son and brother of reaction. Instructed to f/u with md as needed
64 2021-03-01 fainting Pt received first dose of COVID19 moderna vaccine today. After 15min observation period, patient fe... Read more
Pt received first dose of COVID19 moderna vaccine today. After 15min observation period, patient felt well and was discharged. Was in lobby of the center when, per a witness, the patient fainted. The patient recovered consciousness without issue. An MA came to report incident to provider. Was going to bring the patient back to vaccine clinic for further observation. When the MA returned to the lobby, the patient had left.
64 2021-03-03 heart rate increased, arrhythmia, atrial fibrillation Atrial fibrillation; Feeling fluttery; Heart rate was racing and was increasing, went up to 175 just... Read more
Atrial fibrillation; Feeling fluttery; Heart rate was racing and was increasing, went up to 175 just sitting; A spontaneous report was received from a consumer concerning a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation, feeling fluttery, and heart rate was racing and was increasing, went up to 175 just sitting. The patient's medical history was not provided. Concomitant medications included Travatan for glaucoma. On 12 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021, five hours after vaccination, the patient experienced a fluttery feeling, heart rate was racing and was increasing, heart rate went up to 175 just sitting. She took an EKG on her watch and it was atrial fibrillation. When she was sleeping, her heart rate was at 102 or the 90s, normally it would be in the 60s. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events, atrial fibrillation, feeling fluttery, and heart rate was racing and was increasing, went up to 175 just sitting, was unknown.; Reporter's Comments: This case concerns a 64 year old female patient, who was on hospice care experienced a fatal event of death, 1 day after receiving second dose of mRNA- 1273 (Lot# 030M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.
64 2021-03-04 chest discomfort Swelling at site of infection, fever, chills, hives all over body, chest tightness, lip swelling. Pa... Read more
Swelling at site of infection, fever, chills, hives all over body, chest tightness, lip swelling. Patient took benadryl at around 8:00 pm on 3/4/21 and did not get relief so she decided to go to an urgent clinic.
64 2021-03-06 blood glucose increased I have had very increased blood sugar readings since a couple days after vaccine. I am fine because... Read more
I have had very increased blood sugar readings since a couple days after vaccine. I am fine because I have been controlling with rapid acting insulin. My mother is also diabetic and experiencing the same glucose rises. She is managing well also.
64 2021-03-06 chest pain The evening after the injection chills, fever and fatigue for 48 hours.. Fatigue continued for a we... Read more
The evening after the injection chills, fever and fatigue for 48 hours.. Fatigue continued for a week then the following Wednesday after the vaccination on March 3rd. Chest pains began with shortness of breath at about 6pm. Went to the hospital that evening and had xrays and echo which showed signs of fluid and inflammation in the pleural sac. Diagnosis Plurisy. Patient had no history of lung issues or recent sickness other that the vaccination.
64 2021-03-06 loss of consciousness swollen gland armpit night of 2nd vaccine, fatigue next day, chills and hot flashes evening, while s... Read more
swollen gland armpit night of 2nd vaccine, fatigue next day, chills and hot flashes evening, while sleeping tried? to get to bathroom directly connected to bedroom to splash cold water on face, couldn't locate faucet or light switch, woke up on the floor. I know I passed out as I have bruise on butt where I hit the night table. Do not know if I was dreaming, then tried to get up or I had fallen while getting up.
64 2021-03-06 oxygen saturation decreased Day 4 became short of breath and continued to increase each day until hospitalized on March 3, 2021.... Read more
Day 4 became short of breath and continued to increase each day until hospitalized on March 3, 2021. Wheezing, poor response to home meds. Oxygen sat was lowest 88. Dr thought this reaction was due to prior lung infection 2018 (ARDS - staph pneumonia).
64 2021-03-07 blood pressure increased Mild dizziness and elevated blood pressure
64 2021-03-08 atrial fibrillation The called and reported she ended up going into the ER on Friday, March 5th for atrial fibrillation.
64 2021-03-08 chest discomfort Flu like side effects, sinus pressure, tightness in broncial area of chest, headache, aches, fatique... Read more
Flu like side effects, sinus pressure, tightness in broncial area of chest, headache, aches, fatique, foggy brain & dry cough started 24 hrs and continued for 48 hours after the 1st Moderna shot. Stayed in bed and slept a lot. 1 dose of Nyquil Cough to sleep for 2 nights. Felt progressively better and all symptoms just lifted away right at 72 hour mark after shot! I did not see the cough and all the flu like symptoms listed as side effects. So our family started a chat and a cousin's husband - big strapping police captain had the exact same side effects as me.
64 2021-03-08 chest discomfort Awaken around 2:00 am with mild asthma symptoms wheezing and tight chest. Haven't been waken before ... Read more
Awaken around 2:00 am with mild asthma symptoms wheezing and tight chest. Haven't been waken before at night and thought it was unusual. Around 5:00pm that same day I noticed itchiness near the injection site and around the neck. Around 6:00pm I noticed a muscle twitch around the elbow on the right arm. By 7:00 pm my back, chest, and both arms were extremely itching. I took a generic Benadryl and a puff of my Proventil inhaler. This helped a little but I took another Benadryl an hour later. I was able to sleep several hours later. Next morning sill have itchiness but less and asthma symptoms seem better.
64 2021-03-08 heart rate increased Pressure moving across chest from left to right, rapid heartbeat, swollen throat and out of breath. ... Read more
Pressure moving across chest from left to right, rapid heartbeat, swollen throat and out of breath. I also had arm pain and confusion
64 2021-03-09 blood glucose increased, coughing up blood, haemoglobin decreased, cardiac arrest Patient received first vaccine dose on 3/10/21, waited for approximately 1 hour in Pharmacy after. ... Read more
Patient received first vaccine dose on 3/10/21, waited for approximately 1 hour in Pharmacy after. Was walking to her vehicle and became short of breath. Patient got to her vehicle and called 911 due to severe shortness of breath. Rescue arrived on scene at approximately 11:00am, found patient in distress and administered epinephrine, methylprednisolone, and diphenhydramine. Patient placed on CPAP in rescue en route to ER, became unresponsive, frothing pink sputum. Intubated by paramedics en route with iGel device. Patient arrived to ER at 11:22am, went into cardiac arrest at 11:24am. Patient continued to be unstable, had multiple rounds of cardiac arrest and ROSC. Patient ultimately did not survive arrests, and pronounced dead at 2:37pm. Medications received during course in the ER - epinephrine 1mg x18 doses, sodium bicarbonate 50mEq x4 doses, calcium chloride 1g, insulin regular 10 units x1, furosemide 80mg x1, epinephrine titrated infusion, sodium bicarbonate infusion.
64 2021-03-09 loss of consciousness No signs or symptoms ahead of time. While standing at the counter feeding my dogs I passed out on t... Read more
No signs or symptoms ahead of time. While standing at the counter feeding my dogs I passed out on the kitchen floor. The rest of the day I had chills.
64 2021-03-09 palpitations pt said she felt heart palpitation from 4-9 pm. she drank water and stretched and felt better. she r... Read more
pt said she felt heart palpitation from 4-9 pm. she drank water and stretched and felt better. she reported feeling heart palpitation next day . recommended calling dr and seek medical help if needs to.
64 2021-03-10 nosebleed 3/3 to 3/6 sore arm at injection site 3/5 in the morning high pressure in my right sinus (bloody n... Read more
3/3 to 3/6 sore arm at injection site 3/5 in the morning high pressure in my right sinus (bloody nose) it subsided. 3/6 Pain in my right breast tissue that lasted a couple of days. 3/8 started getting a sore right hip in the afternoon and could barely lay down. The pain lasted all night and in the morning I could barely get out of bed. I was able to slide out of bed with considerable pain. Once up I struggled to bend at all. My husband had to put my socks and shoes on. I had to take him to get a medical procedure that morning and I could barely get in the car. I took an Alieve before we left because sitting down was excruciating. I had everything I could do to get up and down from chairs while waiting. When we got back about 10:30 I took another Alieve. It was starting to calm down. I took another Alieve later in the evening and today it still hurts but not as bad. Now it includes my right Knee. I have never had these pains before. I am concerned about my second shot.
64 2021-03-10 hypertension, heart rate increased blood pressure was 286/89/blood pressure was so high; rapid heartbeat; severe inflammatory reaction;... Read more
blood pressure was 286/89/blood pressure was so high; rapid heartbeat; severe inflammatory reaction; fever; headaches; body was in a weakened state; pain in arm; swelling up her arm/swelling in hands; had a severe reaction; swelling at injection site; hot; A spontaneous report was received from a consumer who was also a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe reaction (vaccination site reaction), swelling and warmth at vaccination site, pain in the arm, swelling up her arm/left hand swelling (peripheral swelling), inflammation, rapid heartbeat (heart rate increased), blood pressure was 286/89/blood pressure was so high (hypertension), fever (pyrexia), headache and weakened body state (asthenia). The patient's medical history, as provided by the reporter, pneumonia (had from Dec 2020 to Feb 2021 and had "compromised lungs"), allergies to penicillin and sulfa drugs, vitamin D deficiency, pseudobulbar effect, and traumatic brain injury (with swelling on back of brain stem, memory loss, problems with speech). Concomitant medications included levothyroxine sodium, vitamin C, vitamin D, fish oil, tizanidine, and fluvoxamine. On 18 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:029L20A) in the left arm for prophylaxis of COVID-19 infection. On 18 Feb 2021, after receiving mRNA-1273 the patient reported to have a severe reaction to the vaccination. The patient had swelling at injection site which looked like a bee sting and felt hot. On 19 Feb 2021, the patient reported to experience swelling and very bad pain in left hand. The patient took Benadryl as a treatment. On 20 Feb 2021, terrible pain in arm was reported along with swelling. She went urgent care and they sent her to the hospital, where she stayed for about 8 hours. Test showed a severe inflammatory reaction. She also had headaches, her body was in a weakened state, pain went up her arm, she had a rapid heartbeat and a fever. The patient's blood pressure was 289/89 and they "thought she was going to have a stroke or a heart attack" because her blood pressure was so high. Treatment for the events included steroids and unspecified painkillers. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events peripheral swelling was considered to be not resolved at the time of reporting. The outcome of the events of severe reaction, swelling and warmth at vaccination site, pain in the arm, inflammation, rapid heartbeat, blood pressure was 286/89/blood pressure was so high, fever, headache, and weakened body state was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
64 2021-03-10 hypertension pt states that when she woke up next day after taking vax she was extremely tired, felt like she has... Read more
pt states that when she woke up next day after taking vax she was extremely tired, felt like she has diarrhea (but did not actually have it), chills, and shaking. Her left arm is hurting from the injection site to her neck and down to her elbow. Pt says her BP is 126/71. Heart rate 96. Temp 102.0. Pt has not taking any meds other than her BP and Thyroid meds. Pt has not contacted her PCP at this time.
64 2021-03-10 loss of consciousness PATIENT C/O FEELING DIZZY TO THE POINT OF PASSING OUT X30 MINUTES.
64 2021-03-11 blood pressure increased 3 days ; This letter is to inform you of the unfortunate series of events that landed me in hospital... Read more
3 days ; This letter is to inform you of the unfortunate series of events that landed me in hospital on Friday, January 8, 2021. You denied a brain MRI on January 4th that was an emergent situation, mainly because you had no information about what was happening. I am going to lay out the entire timeline of events, as there are more bills coming. First, I want to give you some background: I am an EXTREMELY fit 64 year old. I work out 6 days a week doing workouts that most 25 year old could not do. I see my OB/GY once a year for my annual checkup. My blood pressure has never been above 110-115/60-70. For my entire adult life, I have never had any serious illness. I should be a dream case for any insurer. I am married to a Board-certified physician in spinal cord injury medicine, EMG, and Neuromuscular Medicine. Together we run the top EMG lab. We have close relationships with the top specialists, which allowed me access to them very quickly. Here is the timeline: On Sunday, December 27, 2020, I was cleaning the baseboards in the bedroom walking backwards. I turned around and hit my left temple HARD on the TV mounted on the wall. I did not pass out, but I actually felt my brain hit the right side of my head from the force. I called my husband and we decided to keep a close watch on me to be sure I did not have a subdural hematoma. For the entire following week, I just had a terrible headache and neck pain. He thought I had a whiplash sort of injury. On Saturday, 1/2/21, I received my first Moderna Covid vaccine. On Monday, 1/4/21, I drove to work. I noticed my vision was a little blurry cut chalked it up to needing new contact lenses. When I got in the car and started driving home, I realized that I had complete and total double vision. I only got home by covering one eye to see the road. I was petrified. On Tuesday morning, my husband called Dr, concussion specialist. He told me to schedule a brain MRI asap. I scheduled it for Friday, 1/8 so company could get approval from you. When we told Dr it was scheduled for Friday, he said I needed it sooner than that, and that he would call in the kind of images he wanted. My friend, who runs the company, got me in that day, and I had an appointment with Dr the following morning, Wednesday, 1/6. I had a very thorough exam with Dr, who said I had a concussion with a partial 6th nerve palsy (double vision). He DID say it was unusual to develop 6th nerve palsy a week after I hit my head, but we were still thinking it was from the concussion. On Friday, 1/8, I was driving to the office with my husband (still could not drive). I ate a breakfast sandwich in the car, and when I went to look in the mirror to see if I had food in my teeth, I noticed I could not move the right side of my mouth. By the time we got to the office, I had a palsy on the entire right side of my face. We called Dr who advised that I go to the ER immediately, as 7th nerve palsy is really not associated with a concussion. We cancelled our patients and he drove me the ER. There I saw Dr, the ER doc, who took one look at me and said I had Bell's palsy. They started taking my vitals and my blood pressure was 220/110! They thought I was having a stroke! They immediately started an IV with medication to reduce my blood pressure. The neurologist came in and ordered another brain MRI with smaller slices than the 1st one to make sure we were not missing anything. He also ordered an MRA. They were all normal. They admitted me to the hospital. After consultation with the Internal Medicine doc, they decided I needed a spina; tap to rule of the many very serious things associated with Bell's palsy. Everything was negative. I was discharged at 1 pm on Sunday, 1/7. I had a follow up with Dr on Wednesday, 1/13. We received a call from Dr who insisted on taking over my case, as he knows my husband very well. I had a consultation with him on Wednesday, 1/13. I gave him the entire timeline of events. I was stunned to hear his opinion: BOTH the 6th nerve palsy AND the 7th nerve palsy were caused by my Covid vaccine. He said he had seen 4 patients in the last 10 days who all developed palsies after their vaccines. They were all Pfizer vaccines, and I was the first Moderna one he had seen. I have since come under the care of Dr who is monitoring my blood pressure. The double vision has resolved, and the Bell's palsy is about 90% improved. I am scheduled for my 2nd vaccine this Sunday, 1/31/ Both Dr want me to go ahead and take it. I have a prescription of Clonidine on hand in case my blood pressure spikes again. It has come back down to about 136/84, which is still high for me. I am absolutely convinced that the blood pressure issue is also from the vaccine. There is no other explanation for my blood pressure doubling. I hope this letter explains the very unfortunate consequences of my Covid vaccine. I have included the progress notes from dr with this letter. Please feel free to contact me at our office.
64 2021-03-11 chest discomfort, blood pressure increased, chest pain 64 yo female s/p 2nd dose of Moderna vaccine. Reports intermittent chest pain and chest pressure. Pa... Read more
64 yo female s/p 2nd dose of Moderna vaccine. Reports intermittent chest pain and chest pressure. Patient escorted into treatment area and evaluated. Clinical and site leads notified. Initial v/s : O2Sat 98%, HR 88, BP left arm 178/95 Patient reports her bp is not usually elevated. 09:45am Vital signs: O2Sat 98%, HR 85, BP left arm 168/98 09:55 am Vital Signs: O2Sat 98%, HR 84, BP left arm 163/97 10:00 am Patient reports her symptoms are without improvement. EMS called. 10:10 am Vital Signs: O2Sat 99%, HR 84, BP left arm 160/91. Initially patient expressed financial concerns about going to the hospital with the EMS and said her son would take her to the hospital. EMS was already in route. At approximately 10:15am EMS arrive on site and patient left with EMS.
64 2021-03-11 heart rate increased Fever up to 101.2. Headaches. Body Aches. Increased resting heart rate. Shortness of breath on a... Read more
Fever up to 101.2. Headaches. Body Aches. Increased resting heart rate. Shortness of breath on any exertion (i.e. walk 20'..) Increased heart rate to 110's with minimal exertion
64 2021-03-12 heart flutter Flutters of heart couple times day of vaccine Following day one or two By Friday woke w flutters and... Read more
Flutters of heart couple times day of vaccine Following day one or two By Friday woke w flutters and continued throughout day in Saturday Had beef flutter free up until time of vaccine
64 2021-03-12 lightheadedness pt was vomiting, near syncope, tremors, laid pt down and put her in trending burg, pt responded well... Read more
pt was vomiting, near syncope, tremors, laid pt down and put her in trending burg, pt responded well BP was 112/62 911 was called. pt recovered and was able to verbalize how she was feeling and was transported to ER for further evaluation.
64 2021-03-13 hypertension Within 30 minutes numbness and tightening of left side of face and throat. After an hour a headache ... Read more
Within 30 minutes numbness and tightening of left side of face and throat. After an hour a headache set on and then neck pain usually associated when my blood pressure goes high. Upon taking blood pressure 3 hours after vaccine. blood pressure registered 107/190. I felt nauseated with head ache.
64 2021-03-14 nosebleed A few hours after shot I felt achy and had joint pain. The following day in the morning I had a nose... Read more
A few hours after shot I felt achy and had joint pain. The following day in the morning I had a nosebleed which is unusual for me. I had had a blood clot and anemia six months prior to vaccine. I had two episodes of diarrhea. I had the second dose of vaccine and had no symptoms.
64 2021-03-14 heart rate increased Complained of "arms, mouth tingle and metal taste in mouth"; Heart Rate increase to 126; Respiratory... Read more
Complained of "arms, mouth tingle and metal taste in mouth"; Heart Rate increase to 126; Respiratory Rate increase to 26; Symptoms subsided after 30 minute wait in recovery observation: Heart Rate 80, Respiratory Rate 16.
64 2021-03-14 hypertension immediate headache, sleepy and high blood pressure after 1st injection. Monitored BP for 40 minutes ... Read more
immediate headache, sleepy and high blood pressure after 1st injection. Monitored BP for 40 minutes and released when BP lowered and stable. Headache gone after 24 hrs and BP normal. One week later on 3/13 "COVID Arm" with bad itching and bad headache. On 3/15 additional symptoms of back ache and fatigue. No response to ibuprofen. Experiencing all symptoms to date, 3/15 pm.
64 2021-03-14 palpitations, chest discomfort 2/10 1015 AM 10PM I was extremely fatigued. Slight HA. Dizziness/light vertigo. Sore shoulder on lef... Read more
2/10 1015 AM 10PM I was extremely fatigued. Slight HA. Dizziness/light vertigo. Sore shoulder on left. Symptoms with stomach cramping lasted into 2/11, all day. By 9PM, I had a severe HA, chills, spent most day in bed. My heart was pounding. Couldn't lay down, HA was throbbing. Temp was 101.5. I contacted my PCM. Advised to rotate between Tylenol and Motrin. The fever did break overnight. 2/12 I was still feeling fatigue, HA. No fever, no chills. Still having vertigo with chest tightness. That had set in on the 2/11. Started my albuterol on 2/11 and lasted till 2/16 with a slight cough. 2/16 Dr was able to see me. She could feel the inflammation in my chest. *Exacerbated the problem because on 2/13 I felt chest tightness and thought it was the asthma, exercises made my symptoms worsen. The acid reflux gave me the sense I was having tight chestness due to the asthma but it was actually due to me exercising on 2/13 which worsened by the 2/15-2/16. I had still had the chest pain, HA Prescribed Advil.
64 2021-03-14 lightheadedness To give context to the adverse event, in early November 2020 I was diagnosed with Bell's Palsy of un... Read more
To give context to the adverse event, in early November 2020 I was diagnosed with Bell's Palsy of unknown origin on the left side of my face. I was tested for COVID-19 and it came back negative. It resolved itself in about a month. About 8 hours after receiving the COVID-19 vaccine on 3/9/21 (about 6:30 p.m., I started to feel a slight headache. Because I had just had the vaccine, I was trying to avoid taking any pain medication, so I did not take anything for it. The headache got worse throughout the evening, and by 10 p.m. I would describe it as a moderate headache. It was primarily concentrated on the left side of my head towards the front, on my forehead and above the eyebrow. I went to bed without taking any pain medication. About 3 hours later, at about 1 p.m., I woke up, and the headache was much more intense. It felt like all the nerves around the left side of my face, including the nerve along my jaw line leading to the 7th cranial nerve that causes Bell's Palsy, were throbbing. I grew concerned about getting Bell's Palsy again, so at that time I took one ibuprofen Advil. After taking it, the headache subsided, although I continued to have a dull headache throughout the night and the next day. Patient received the vaccine Monday March 1st around 2:30pm. Patient began to feel arm soreness around 5pm, woke up at 3am the following morning with a severe headache and spent the next day resting. Wednesday morning March 3rd, the patient reported extreme fatigue, dizziness and feeling "woozy". As she was walking around the store, around 8:30am, patient had to request help as she almost fainted. Patient went home quickly after, reported dizziness until 3pm. Patient's friend who is a nurse came to her home to check her vitals, confirmed they were normal and encouraged fluids/rest. After resting further Wednesday/Thursday, patient returned to work Friday morning and has been fine since. Patient did not take any medications prior/during/after incident.
64 2021-03-14 fainting Fainted; Sweating; Vision was blurry; It went "black; Whole skin feels cold; Felt something weird on... Read more
Fainted; Sweating; Vision was blurry; It went "black; Whole skin feels cold; Felt something weird on her body; vision was sparkly; Chills; A spontaneous report was received from a Consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt something weird on her body, sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird. The patient's medical history was not provided. Products known to have been used by patient, with in two weeks prior to the event, included levothyroxine, lisinopril, amlodipine, omeprazole, atorvastatin, baby-aspirin, lisinopril hydrochlorothiazide. On 2-Jan-2021, patient received the first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly at right arm . On 28-Jan -2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly at right arm for prophylaxis of COVID-19 infection. On 21-Feb-2021, the patient experienced the events felt something weird on her body. sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird. Treatment information was not provided. The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable The outcome of events, felt something weird on her body, sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
64 2021-03-15 heart rate increased, chest discomfort Hives, extreme dizziness, weakness, headache, hives, nausea, rapid hearbeat, chest pressure, shortne... Read more
Hives, extreme dizziness, weakness, headache, hives, nausea, rapid hearbeat, chest pressure, shortness of breath, sweating, throat tightness. Admitted to emergency room at Hospital.
64 2021-03-15 heart rate increased, hypertension The following day I woke up with almost a Migraine Headache, Fatigue, Blood Pressure and heart rate ... Read more
The following day I woke up with almost a Migraine Headache, Fatigue, Blood Pressure and heart rate very high, Fever 103.7 max, , was in bed all day. (same symptoms I had with Covid 19 in November) The second day I was able to be up and do work, but again that evening my temp was up to 102.6, very feverish. Third day in the evening, night my temp was at 101.7 max. Fourth day, no fever, back to normal.
64 2021-03-15 palpitations had vaccine on 3/10 was fine until 3/13 at 3pm got extremely fatigued and around 6pm had chills and ... Read more
had vaccine on 3/10 was fine until 3/13 at 3pm got extremely fatigued and around 6pm had chills and fever woke up drenched in AM, 3/14 around 6 got chills and fever woke up, drenched in AM, 3/15 around 6pm got chills and fever woke up at midnight with my heart pounding, final calmed down a bit an went back to sleep woke up drenched in sweat again. 3/16 started getting chills again around 4pm have slight temp.
64 2021-03-16 chest discomfort Shortly after the first dose I experienced chest pressure for approx. 10 minutes and slight difficul... Read more
Shortly after the first dose I experienced chest pressure for approx. 10 minutes and slight difficulty breathing.
64 2021-03-16 lightheadedness 11AM Called to assess patient reports pre syncope in post vaccine observation area. Patient is stati... Read more
11AM Called to assess patient reports pre syncope in post vaccine observation area. Patient is stating that she is "lightheaded" BP 122/70, pulse 83, RR 16, provided with Sprite and pretzels as patient states that "this has happened before after an injection." Presyncope resolved in 10 minutes and released. Instructed patient to contact provider for follow up. Patient verbalized understanding and dismissed at 11:50AM
64 2021-03-17 chest discomfort Patient complained of some tightness in her chest along with a slight cough,
64 2021-03-17 heart rate increased itching, increased heart rate
64 2021-03-17 fainting I was not feeling quite right and I fainted after getting up in the morning.
64 2021-03-20 palpitations I HAD PAIN AT SITE, CHILLS, HEADACHE AND BODY PAINS THE DAY AFTER THE SHOT. TREATED WITH TYLENOL. ... Read more
I HAD PAIN AT SITE, CHILLS, HEADACHE AND BODY PAINS THE DAY AFTER THE SHOT. TREATED WITH TYLENOL. ON DAY 4 I GOT A TERRIBLE METALLIC FOUL TASTE THAT I AM STILL DEALING WITH. ALSO HAD HEART PALPATATIONS AND DIZZY QUEAZY FEELING. THE HEART PALPATATIONS ARE NOW LESS BUT THE TASTE DISORDER IS STILL THERE. WILL IT GO AWAY? MY WORK REQUIRES THAT I CAN TASTE.
64 2021-03-21 chest discomfort 350pm pt with a history of COPD/emphysema uncontrolled, on oxygen and nebs at home. about 15 minute... Read more
350pm pt with a history of COPD/emphysema uncontrolled, on oxygen and nebs at home. about 15 minutes after recieving covid vaccine #1 pt began c/o sob and chest tightness. stated was having a hard time breathing.pt appeared to be having a hard time breathing and catching breath. RNs asisting pt. BP 110/88 P 110 SA O2 95% Called for Dr. per Dr-pt was tight with decreased air exchange. pt with increased work of breathing 353pm V.O Dr epi 1mg IM now Solumedrol 125mg/2ml IM now Albuterol neb 2.5mg/ml now 354pm gave Epi 1mg IM R arm. ................................................................... RN March 22, 2021 5:10 PM 355pm started Albuterol neb 2.5mg/3ml PO ................................................................... RN March 22, 2021 5:10 PM 358pm gave Solumedrol 125mg/2ml IM R arm ................................................................... RN March 22, 2021 5:11 PM pt states she is starting to feel better. not havign as much sob breath. is not having to work as much to breathe. 407pm P 107 SA O2 95% pt states she is feeling alot better. feels a little shaky however denies sob and states can breath alot easier now. albuterol neb is still running. Pt appears to be more comfortable. 410pm albuterol neb is complete BP136/84 P 106 SA O2- 95% PT states feels alot bettter. denies sob, dizziness, swelling of throat or tongue, itchiness or rash, dizziness, hand/fett tinglling or numbness. pt states that she is much more comfortable now and her breathing is alot more easire now. pt appears to be more comfortable now. per Dr- pt has better air exchange now with no wheezing. pt advised to use rescure inhaler and nebs at home. given ER precautions. Pt verbalized understanding. Walked out of clinic on own will to dial a ride. ...................................................................RN March 22, 2021 5:17 PM
64 2021-03-21 chest pain Burning in my chest, Immediately throat tightness, episodes of shortness of breathe lasting for ho... Read more
Burning in my chest, Immediately throat tightness, episodes of shortness of breathe lasting for hours about about 4 hours after receiving Moderna my breathing pattern was so bad I considered ER. Also I developed a cough about 20 minutes after the vaccine. In fact it has been a week later and I still have coughing.
64 2021-03-21 heart rate increased The same day my heart rate increased. Had an asthma attack. Brain fog. Chills. Both legs hurt (front... Read more
The same day my heart rate increased. Had an asthma attack. Brain fog. Chills. Both legs hurt (front). Fatigue to point of exhaustion, sleep long hours. No energy at all. Made my chronic illnesses much worse
64 2021-03-21 heart rate increased Dizzy, heart beat fast, stomachache, headache. Tylenol
64 2021-03-21 ischaemic stroke Acute stroke (Expressive aphasia) . Went to emergency room, and hospitalized for 2 days. Left tempo... Read more
Acute stroke (Expressive aphasia) . Went to emergency room, and hospitalized for 2 days. Left temporal ischemic stroke was diagnosed. Aspirin, Plavix, tPA, Atorvastatin were used. Discharged in 2 days with pretty good recovery.
64 2021-03-21 fast heart rate Tachycardia ongoing
64 2021-03-22 haemoglobin decreased, pulse abnormal 3/20/21 06:22 pm Resident c/o Nausea and feeling full- Tube feeding placed on Hold- Resident started... Read more
3/20/21 06:22 pm Resident c/o Nausea and feeling full- Tube feeding placed on Hold- Resident started vomiting- Zofran 4 mg given- Positive outcomes. 03/21/2021- 0430 Resident found unresponsive on morning rounds- w/ weak pulse, shallow breathing. O2 via NC increased to 5 L, NP, Family ( Code Status DNR)- Power of attorney ordered to send out- MR notified- Upon arrival no rhythm detected- Death pronounced at 0445
64 2021-03-23 atrial fibrillation, heart rate increased Patient has A. Fib and on the first dose the EMS was called because of her rapid heart rate. Patient... Read more
Patient has A. Fib and on the first dose the EMS was called because of her rapid heart rate. Patient HR became 115 bpm after second dose. Onsite EMS was called vitals HR 95 BP 175/96. Symtoms subsides and was able to go home.
64 2021-03-23 cardiac arrest 2/25/2021 She was taken to the hospital for aspiration. 03/09/2021 was discharged, but relatives wer... Read more
2/25/2021 She was taken to the hospital for aspiration. 03/09/2021 was discharged, but relatives were informed that she was unwell. 3/13/2021 When they went to take the rounds she was without signs, she was sleeping. He refers that the patient died of Aspiration Pneumonia and was tested at the Hospital with negative results. They certify death due to cardiovascular arrest
64 2021-03-23 fainting Customer received vaccine and shortly began to feel dizzy, lighted-headed, and fainted while seated.... Read more
Customer received vaccine and shortly began to feel dizzy, lighted-headed, and fainted while seated. She became responsive and was sweating stating she did not feel well. Customer complained of feeling nauseated, hands were cramping and difficult to move. Finger tips were tingling. She sat in our waiting area and was observed for over 30 minutes. She began to feel better after 15-30 minutes.
64 2021-03-24 chest discomfort High fever, body aches, cough, chest pressure, dizziness, lack of energy, lack of sleep, headache
64 2021-03-24 heart rate increased Took 1st dose 01/27/12021 . 8days later developed rash on right arm where vaccine given. Took bena... Read more
Took 1st dose 01/27/12021 . 8days later developed rash on right arm where vaccine given. Took benadryl orally and topically cortisone cream .Gone after 4days. Got 2nd dose 02/27/21. Next day developed fever 101.6 with rapid heart rate took tylenol . Had to go to hospital because heart rate remained 120 to 130. All lab normal EkG tachycardia came down on own
64 2021-03-24 heart rate increased On Day 4 after the vaccine she experienced a rapid heart rate of 132 ppm! Day 5 we called our family... Read more
On Day 4 after the vaccine she experienced a rapid heart rate of 132 ppm! Day 5 we called our family doctor and made an appointment!
64 2021-03-25 blood pressure increased On 3/25/2021. Within about 10 minutes after taking the covid vax the pt started saying she could no... Read more
On 3/25/2021. Within about 10 minutes after taking the covid vax the pt started saying she could not swallow. BP was little elevated, her O2 was 94, Pulse rate 88. Pt started to panic and then given Epi injection which did not help. 911 was called. Pt was talking and able to walk to the gurney. She was transported by ambulance to ER .
64 2021-03-25 haemoglobin decreased She had sudden onset of fatigue, stiffness, joint pains in her shoulders and hips bilaterally, and d... Read more
She had sudden onset of fatigue, stiffness, joint pains in her shoulders and hips bilaterally, and depression. The pain was worst in the mornings and across the shoulder girdle. These were the most severe symptoms she had ever had and they reduced her to about 50% of her usual capacity. These symptoms started much more suddenly than past joint aches and were persistent without any improvement for two weeks, leading her to seek care on 3/2/2021. This provider checked labs and referred her to specialist. I saw her on 3/17/2021, ordered a few more labs, and prescribed prednisone on 3/22/2021 for suspected polymyalgia rheumatica. She is starting to have less pain, fatigue, and depression as of 3/26/2021.
64 2021-03-25 heart rate increased, loss of consciousness Pain/pressure at injection. Within 2 min. Passed out for 5 to 10 seconds then tingling of arms/hands... Read more
Pain/pressure at injection. Within 2 min. Passed out for 5 to 10 seconds then tingling of arms/hands and legs. Sweating head and neck. Cramping of both hands, unable to move fingers lasting 2 to 4 minutes. Burped almost throwing up twice. Possible rapid heartbeat causing rapid breathing. Was asked to and did stay 30 to 45 minutes. Was better within 10 minutes of injection. At home experienced being very cold some mild soreness of arm. Temperature of 96 at 3:15 pm. Temp back to normal next day.
64 2021-03-28 chest discomfort, palpitations Heart racing for 1 hour chest felt heavy 2 hours hard to swallow 15 minutes labored breathing 15 min... Read more
Heart racing for 1 hour chest felt heavy 2 hours hard to swallow 15 minutes labored breathing 15 minutes weakness 2-3 hours severe headache for 3 days I took extra Metoprolol for heart racing and tightness in chest I took Tylenol and Advil for headaches each day together
64 2021-03-28 pulmonary embolism, fluid around the heart Large volume obstructive PEs with bilateral pleural and pericardial effusions
64 2021-03-29 loss of consciousness I passed out, vomited and a heavy sweating.
64 2021-03-30 blood glucose increased Fever / body aches / high blood sugars
64 2021-03-30 chest discomfort Flash feeling of exhaustion . dizziness head felt cloudy unable to count or think clearly.. coughing... Read more
Flash feeling of exhaustion . dizziness head felt cloudy unable to count or think clearly.. coughing sore throat, headache, nausea, chill's and sleeping more than normal, tightness in chest
64 2021-03-30 fibrin d dimer increased, pulmonary embolism, troponin increased presented 5 days after Covid vaccine with massive pulmonary emboli
64 2021-03-31 cerebrovascular accident Stroke; Bad headache; Very tired; Right side of her body numb; A spontaneous report was received fro... Read more
Stroke; Bad headache; Very tired; Right side of her body numb; A spontaneous report was received from a consumer, concerning a female patient (herself) of 64-years-old, who received Moderna's COVID-19 vaccine and experienced headache, tiredness, stroke/ Cerebrovascular accident and right side of her body numb/hypoaesthesia. The patient's medical history included high blood pressure, migraine, high cholesterol, obesity, fusion of spine and neck surgery and numbness on the right side. Products known to have been used by the patient, within two weeks prior to the event included unspecified blood pressure medications. On 18 Mar 2021, approximately four days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 006B21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 18 Jan 2021 night, the patient experienced a bad headache and was very tired. On 20-Mar-2021, the patient felt better and went for a walk. On 21 Mar 2021, Sunday, at 1:00 am the patient experienced stroke and was hospitalized subsequently. The event stroke was considered as medically significant and required hospitalization. On 24 Mar 2021, the patient was discharged from hospital and she stated that the stroke had left her entire right side of the body numb. Treatment for the events included atorvastatin, aspirin. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events headache, tiredness, stroke/cerebrovascular accident was considered as resolved/recovered on 24 Mar 2021. The outcome of the event right side of her body numb/hypoaesthesia was considered as not recovered at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
64 2021-03-31 chest pain 3/29/2021 5:32 PM:Searched for moderna, added Moderna COVID-19 Vaccine (SARS-COV-2 (COVID-19) Vaccin... Read more
3/29/2021 5:32 PM:Searched for moderna, added Moderna COVID-19 Vaccine (SARS-COV-2 (COVID-19) Vaccine, mRNA (Moderna) 100 MCG/0.5 ML) Intramuscular Suspension Received call from 64 yo female wt 165 lbs who had received 2nd Moderna vaccine yesterday around 1045. Today about an hour ago, she developed chest pain which continues. I recommended that she needs to call 911 or ED eval. COVID staff will follow-up for more details. 3/30-Spoke to patient, she is feeling much better after taking 2 benadryls and ibuprofen last night.
64 2021-03-31 platelet count decreased, cerebral haemorrhage Brain bleed; Platelet count droppped to 40; Bruises all over the body; Organs shut down; A spontaneo... Read more
Brain bleed; Platelet count droppped to 40; Bruises all over the body; Organs shut down; A spontaneous report was received from a consumer concerning a 64-year-old female patient, who experienced bruises all over the body (contusion) , brain bleed (cerebral haemorrhage), platelet count dropped below 40 (platelet count decreased) and organs shutdown (multi organ failure). The patient's medical history included bacterial infection 2 days prior to receiving vaccine dose. Product known to have been used by the patient, within two weeks prior to the event, included antibiotics (not specified). On 02 Mar 2021, the patient received her first of the two planned vaccine doses of mRNA-1237 (Lot # unknown) for prophylaxis of Covid-19 infection. On 03-Mar-2021, the patient developed severe bruises all over her body. On 04 Mar 2021, within 2 days after receiving the vaccination, the patient was rushed to the hospital where it was determined that she had sustained a brain bleed. She had all her organs shutdown and her platelet count had dropped below 40. On 04 Mar 2021, it was reported that the patient died. The cause of death was reported as organ failure. Plans for autopsy were not provided. Action taken with the mRNA-1273 in response to the events was not applicable. The outcome of the events, bruises all over the body(contusion), brain bleed(cerebral haemorrhage), platelet count dropped below 40(platelet count decreased) were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's underlying history of bacterial infection could be a contributory factor. Awaiting further clarification.; Reported Cause(s) of Death: Organ Failure
64 2021-04-01 chest pain Thursday 4/1/21: Tiredness, all over joint pain, shoulders and shoulder blades sore, neck pain espe... Read more
Thursday 4/1/21: Tiredness, all over joint pain, shoulders and shoulder blades sore, neck pain especially on left side, ear ache on right side, congested, head ache, fever up to 102.3, fever for approximately 20 hours, nauseous. Friday 4/2/21: awoke with chest (not heart) pain, congested, runny nose, cough (I sometimes have a little congestion and cough in the mornings but not like this)
64 2021-04-01 chest pain Severe pain in back and chest. Itchy bumpy rash on back and left breast and spreading. Today my feet... Read more
Severe pain in back and chest. Itchy bumpy rash on back and left breast and spreading. Today my feet are swollen. It's been 2wks since shot and I'm not getting better.
64 2021-04-01 heart rate increased My immediate reaction was blurred vision, then pain down my right arm. Next my pulse rapidly increas... Read more
My immediate reaction was blurred vision, then pain down my right arm. Next my pulse rapidly increased, and my breathing was labored. My finger tips of both hands felt almost numb, and my hands turned red. I became very lethargic, and both legs became very weak. I remained in the facility for 1.5 hours under the care of a RN. I went home and it took approximately 4 hours for me to recover. 3 days later I woke up with a metallic taste in my mouth that lasted 2 days.
64 2021-04-03 blood pressure increased, heart rate abnormal Injection Wed. Slight bone aching Wed night. Good Thur with slight arm soreness. My son woke me abou... Read more
Injection Wed. Slight bone aching Wed night. Good Thur with slight arm soreness. My son woke me about 3 AM Thurs night. I had to lay back down due to fast heart rate and feeling of nearly passing out. Happened 2 times. Friday day was ok. Same thing happened Friday night and Saturday I felt bad all day with episodes lasting longer periods and BP was elevated with highest checked 166/104. I had some aching between shoulder blades and left arm. Mild to moderate headaches each day. I did not contact doctor. I have a special needs son with no help on weekends or nights. I feel better today. Heart rate went from 69 to 131 at one point when checking. I sit or lay until it lowers and then slowly get up to do what is needed. Head ache today. But I also stopped my caffeine which is normally 2 cups a day. BP IS 138/93 now with sitting.
64 2021-04-04 fainting "Moderna COVID19 Vaccine EUA" Hospitalized for weakness vomiting and diarrhea. suffered a fall afte... Read more
"Moderna COVID19 Vaccine EUA" Hospitalized for weakness vomiting and diarrhea. suffered a fall after getting dizzy and syncopal episode
64 2021-04-04 fainting Nausea, dizziness, fainting x 3 weeks, "cyst in arm that something came out of, like a little ball, ... Read more
Nausea, dizziness, fainting x 3 weeks, "cyst in arm that something came out of, like a little ball, I pinched it to try to squish it, and it was hard". Per patient, arm then bled.
64 2021-04-05 chest discomfort Patient received vaccine and was sent to observation area. She began having altered mental status, s... Read more
Patient received vaccine and was sent to observation area. She began having altered mental status, slight aphasia, and confusion. Snack was offered and patient was assessed. She had difficulty answering questions and complained of chest feeling abnormal. B/P taken 230/140. 911 services called. Transported to hospital at 12:52
64 2021-04-05 chest pain Sharp quick pains up neck, across chest, in knees all day on day after vaccination along with mild ... Read more
Sharp quick pains up neck, across chest, in knees all day on day after vaccination along with mild headaches. Weakness second full day after vaccination. Headaches all night leading into the third day. Woke with dry heaves on third day. Weakness on forth day.
64 2021-04-05 heart rate increased injection site swelled on day 7. Still swollen and red and itchy. hurts .. itches..swollen the size... Read more
injection site swelled on day 7. Still swollen and red and itchy. hurts .. itches..swollen the size of baseball ... red... Hurts down the arm ... sweating....toes are numb... both feet...leg cramps are terrible both legs.. headache little white bumps on belly. When I lay down my heart beats fast. leg cramps keep me awake at night.
64 2021-04-05 palpitations, cardiac arrhythmia Hearing loss in right ear - from 2:30 am to midnight 4/3/21 Racing heart and serious PVCs - from 2:3... Read more
Hearing loss in right ear - from 2:30 am to midnight 4/3/21 Racing heart and serious PVCs - from 2:30 am to 9:00 pm 4/3/21 Dizziness, fever, horrible body aches, headache, mild nausea all day 4/3/21 Complete exhaustion from 4/3/21 to 4/4/21 all day
64 2021-04-06 loss of consciousness, pallor On 4/3/21 at 7 AM, I tried to get up to brush my teeth, but was unable to stand. I sat down in the ... Read more
On 4/3/21 at 7 AM, I tried to get up to brush my teeth, but was unable to stand. I sat down in the chair in front of my sink and called for my husband. I was very hot and sweaty. When my husband got to me I had passed out, unresponsive and was very pale. After 5 minutes I was able to respond to him. He asked if I could sit up. I said no so he put me back in bed. After 2 hours of sleep, I was able to get up and dress. I rested the rest of the day but checked and found that I had a fever of 99.6F. The fever lasted the day and was gone the next morning. The next morning I was OK.
64 2021-04-06 loss of consciousness these symptoms began around 8 pm on 4/5/21 - Headache - severe; chills; muscle aches in neck and upp... Read more
these symptoms began around 8 pm on 4/5/21 - Headache - severe; chills; muscle aches in neck and upper back; nausea; dizziness upon awakening on 4/6/21 such that when brushing teeth in morning, I blacked out and fell to the floor hitting my head. fatigue all day on 4/6/21 above symptoms resolved at 11:00 pm on 4/6/21
64 2021-04-06 palpitations April 2 vaccine - injection shot location pain Day 2 - flu like symptoms Severe body aches, fever, t... Read more
April 2 vaccine - injection shot location pain Day 2 - flu like symptoms Severe body aches, fever, terrible sinus pressure, fluid in ears. Slept all day Took Advil, aspirin, Benadryl, corcidin. Day 3- reduced by 1/3 still weak and tired Day 4- reduced still. Mostly sinus pressure, vertigo, aches, fatigue Day 5 woke up with some sinus, tired, vertigo Day 6 woke up with some sinus still tired, vertigo but was relatively better. About 12 noon heart started racing felt very lightheaded and dizzy. Felt like I was going to pass out. After about an hour or so it started to subside and I felt very drained and tired. still feeling unwell. Loss of apetite
64 2021-04-06 fainting Fainted
64 2021-04-07 hypertension Eleven mins after shot, pt notified me that she was feeling dizzy and c/o burning to bilateral eyes.... Read more
Eleven mins after shot, pt notified me that she was feeling dizzy and c/o burning to bilateral eyes. Escorted pt to lie down on gurney. Three minutes later, observed bilateral eye swelling. Pt was hypertensive 221/105. Pt also had headache. Pt then c/o Left throat soreness then abdominal pain. Pt had chills, temp was normal. EMS called, pt transferred to nearest emergency department.
64 2021-04-07 fainting Patient was feeling light headed, shaky and started to sweat. She then fainted and was caught by mys... Read more
Patient was feeling light headed, shaky and started to sweat. She then fainted and was caught by myself. We immediately called 911 , her blood pressure was taken and it was within normal limits. She did not have any difficulty breathing, swelling of the tongue or other side effects that were showing signs of anaphylaxis. Patient received water and started to feel cooler and less shaky. Once the paramedics arrived, she was assessed and was monitored for at least 25 minutes by myself and the paramedics. Patient was not disoriented and was given the OK to go home by the paramedics. Patients husband was contacted to come and drive her home.
64 2021-04-07 fainting Patient was in waiting area for 15 minutes post-vaccination, told me she was feeling dizzy. I gave ... Read more
Patient was in waiting area for 15 minutes post-vaccination, told me she was feeling dizzy. I gave her water and took her BP (117/84) and pulse (69). I asked her to wait an additional 10 minutes. Checked on her again, said she was doing better. Asked my associate to take her BP one more time before we sent her home about 5 minutes later. Associate went to go take her BP and patient fainted for a few seconds, woke up and vomited. At this point the paramedics were called and we were monitoring the patients.
64 2021-04-08 heart flutter Pt started having feeling of "flutter feeling on her heart," 5 mins after vaccination. 2 episodes of... Read more
Pt started having feeling of "flutter feeling on her heart," 5 mins after vaccination. 2 episodes of flutter like feeling, 1st one lasted 15-20 mins. after 5 minutes resolved then started having the flutter feeling on her heart again. Patient did not have chest pain, sob, dizziness, swelling of lips/tongue, throat. HR was elevated to 114 initially and 2nd episode with 119 bpm. otherwise, rest of vital sign stable. Action: vital signs and observation Called clinician of the day Dr. and recommended sending patient to Emergency Department for higher level of care. Paramedics came and patient went to Emergency Department.
64 2021-04-08 chest pain, chest discomfort Patient reports chest tightness, pain is 5/10, EMS assessed patient and performed EKG (normal), BP: ... Read more
Patient reports chest tightness, pain is 5/10, EMS assessed patient and performed EKG (normal), BP: 217/108, second reading 178/101, pulse:85, patient reports chest pain continues 4-5/10 , Patient was transported to emergency room by ambulance.
64 2021-04-08 hypotension, chest discomfort Patient received 1st dose Moderna vaccine. After vaccination found to have white nodules on posterio... Read more
Patient received 1st dose Moderna vaccine. After vaccination found to have white nodules on posterior tongue/mouth. Patient described increased difficulty breathing and chest pressure. Patient stated has history of asthma. Physical exam and vital signs completed by RN and NP. Pt. A&O X 3, GCS 15, RR 18, BP 107/58 HR 60, no other findings on exam. Patient received benadryl 25mg PO. EMS called at this time. Upon arrival of EMS transfer of care without incident.
64 2021-04-08 fast heart rate, chest discomfort weakness, shakey, tachycardia, chest pressure began 6 hours after vaccination. no cardiac history, ... Read more
weakness, shakey, tachycardia, chest pressure began 6 hours after vaccination. no cardiac history, ischemic changes on ekg. IVF given, HR normalized, repeat ekg: resolution of ischemic changes.
64 2021-04-09 blood glucose increased By 6 hours later, I just didn't feel well, tired, achy, developed a fever at 10pm was 100, at 11pm... Read more
By 6 hours later, I just didn't feel well, tired, achy, developed a fever at 10pm was 100, at 11pm was 101.4, at 12:30am was 103. Had chills . Fever broke at 3am, Very sweaty. took a aspirin at 10pm and another one at Midnight. Also raised my blood sugar. Was 393 in early morning, took extra insulin. My levels run under 250 normally. Feeling fine now,
64 2021-04-09 heart rate increased Beginning around 9:30 pm - fever, chills, body aches, tiredness, and racing heartbeat.
64 2021-04-09 fainting Syncope
64 2021-04-11 cerebrovascular accident After having immunization on 3/25/2021, began feeling weak with low grade fever (99.9) after feeling... Read more
After having immunization on 3/25/2021, began feeling weak with low grade fever (99.9) after feeling like that for a day, daughter (nurse) noticed drawing of facial muscles and weakness to left side. took her to local hospital where they then transferred her to another hospital where they admitted her and performed a CT of brain which was positive for a stroke. Patients daughter states patient continued to run low grade temp until yesterday and is being discharged today
64 2021-04-11 chest pain I had my first Moderna vaccine on April 2 and my arm didn't hurt, it was tender around the injection... Read more
I had my first Moderna vaccine on April 2 and my arm didn't hurt, it was tender around the injection area but was only slightly painful if I accidentally poked it, I could sleep on it, etc. That got better after three days and there was nothing and on April 10, 8 days later I have significant pain and the area around the injection site is all red and swollen and the operation of my whole arm has been affected (significant pain to type on a computer) and the pain grew to include my collarbone area as well. I took 600 mg of Ibuprofen and a sleeping aid and slept for 10 hours, it was much better the following day, although still swollen and red and still better today day 10 from the injection..
64 2021-04-11 palpitations Starting at about 6 pm that evening, had a fever of 100 and uncontrollable chills and shivering. Shi... Read more
Starting at about 6 pm that evening, had a fever of 100 and uncontrollable chills and shivering. Shivering became extreme (teeth actually chattering) by about 7pm, and whole body aches becoming profound. At about 7pm or so, I took 2 tylenol and got into a very hot bath. It took about 15 minutes for the chills/goosebumps and shivering to stop. But then I worried about pushing my temp up higher and protecting my brain, so I got out, took my temp, and it had shot up to nearly 102. So, I dried off and began shivering again, got into bed under 2 quilts and a wet cloth on my forehead and neck to cool my head. Finally the chills calmed down about a half hour later and I slept fitfully til I got out of bed about 6:30. But my heart was pounding hard all night, and in the morning I still had a degree temp over my morning normal and the aching felt worse. I finally relented again at about noon and took 2 more tylenol. Within about 1-2 hours, I finally started to begin feeling better. That evening I went to bed early after taking one of my cetirizine allergy pills and slept like the dead. Yesterday I felt pretty good except my arm was still a bit spore, same thing today except arm seems better.
64 2021-04-11 fainting Headache , fatigue and faintness. Night of the injection I was very cold and had a hard time getting... Read more
Headache , fatigue and faintness. Night of the injection I was very cold and had a hard time getting warm. Next day unable to eat very much for most of the day and felt horrible, felt chilled for most of the day, faintness very bad til late that evening. Second day after injection was back to normal.
64 2021-04-11 fainting Syncopal episode, resulting in a fall ad injury to head, neck and chest.
64 2021-04-11 fainting Friday morning 10 hours of temp, as high as 101.2. Went to bed and got up at 4:15 am woke up with na... Read more
Friday morning 10 hours of temp, as high as 101.2. Went to bed and got up at 4:15 am woke up with nausea , got up one more time around 4:30 to go to the bathroom and woke up on the bathroom floor. Had passed out. Went to on Monday and was told that she had a concussion.
64 2021-04-12 chest pain 2 days after the vaccine, I became very, very sore on all parts of body. My back seemed to feel it t... Read more
2 days after the vaccine, I became very, very sore on all parts of body. My back seemed to feel it the most. I could not get comfortable in any position. This was to the point of crying because SO bad. I slept for about 36 hours without taking anything. I developed a bad cough the next day with a fever. My chest hurt. Horrible headache for about 27-28 hours. Aspirin did not help. Neck sore and injection site very sore although no marks show up.
64 2021-04-12 nosebleed prolonged nose bleed, lasting up to 6 hours. heavy at times
64 2021-04-12 pulmonary embolism, chest pain Had systems of fatique and chest pain. Went to hospital of 4/12/2021 . Learned that had blood clots ... Read more
Had systems of fatique and chest pain. Went to hospital of 4/12/2021 . Learned that had blood clots in lungs that I previously did not
64 2021-04-12 blood clot Shortness of breath , extreme pain 3 hospital visits until blood clot was detected,now on blood thin... Read more
Shortness of breath , extreme pain 3 hospital visits until blood clot was detected,now on blood thinner Eliquis
64 2021-04-13 chest discomfort, heart rate increased Tight, full chest; rapid heart rate for 2.1 weeks. Arms and legs falling asleep.
64 2021-04-13 haemoglobin decreased, low blood platelet count, platelet count decreased, pulmonary embolism, anaemia immune mediated thrombocytopenia, anemia, pulmonary embolism, pulmonary infiltrates. treated with IV... Read more
immune mediated thrombocytopenia, anemia, pulmonary embolism, pulmonary infiltrates. treated with IVIG x 2 days and prednisone 120 mg daily. started on heparin drip.
64 2021-04-13 heart rate increased Felt mild weakness after administration. 22 hours later had rapid heart beat while standing of 140+/... Read more
Felt mild weakness after administration. 22 hours later had rapid heart beat while standing of 140+/ min. Would slow somewhat with lying down. (100-120/ min) Temp of 100.3. Took Tylenol every 6 hours.Forced fluids and rested. Resolved within 6 hours.Developed sporadic hives on torso for next 24 hours. No breathing problems and stable BP through the event. Reported Event to FMD and Allergist next day. General mild weakness for next 7 days.
64 2021-04-13 heart attack Cranial and spinal SAH hematoma at roughly same time as heart attack. Cause of hematoma was unknow... Read more
Cranial and spinal SAH hematoma at roughly same time as heart attack. Cause of hematoma was unknown. Potentially a side effect of elliquis; but her cardiologist does not believe ellipsis was the cause. Heart attack at similar time due to blood clot and blocked artery and possibly reaction of body to hematoma. We do not have any hard data that either are related to the vaccine; but are reporting them under the advice of a doctor to give information for science.
64 2021-04-14 cardiac arrest Patient per tracking received 2nd COVID vaccine on 4/5/2021 from Health Department. Patient to Hos... Read more
Patient per tracking received 2nd COVID vaccine on 4/5/2021 from Health Department. Patient to Hospital Emergency department via EMS 4/6/2021 with cardiac arrest and death
64 2021-04-14 fast heart rate Extreme SOB with exertion 1 \week after each injection. Continued SOB with activity such as walking,... Read more
Extreme SOB with exertion 1 \week after each injection. Continued SOB with activity such as walking, cooking, ALD's. 2-9-21 admitted to hospital extreme SOB, Tachycardia- r/o PE. Negative US, and CT. 2-12-21- to Cardiologist- not heart failure causing SOB, recommend course of steroids 2-24-21 to PCP short course of steroids, relieved SOB. but SOB returned after weaned off. 4-16-21 going to pulmonologist
64 2021-04-14 fast heart rate Patient began having nausea, itching and tachycardia approximately 15 min after injection. Symptoms... Read more
Patient began having nausea, itching and tachycardia approximately 15 min after injection. Symptoms progressed to feeling of tightness of the throat, diaphoresis, swelling of the eyelids and worsening nausea and itching.
64 2021-04-15 chest pain arm is hard very very red and hot to touch; arm is hard very very red and hot to touch, oozing in th... Read more
arm is hard very very red and hot to touch; arm is hard very very red and hot to touch, oozing in the middle of the night; progressively ill-er with a temperature 101.2; severe chills; nausea; vomiting turned to purely vomiting blood; did not feel very well; diarrhea; chest pain; Cervical dystonia and tremors which has gotten visibly worse; Cervical dystonia and tremors which has gotten visibly worse; arm is hard very very red and hot to touch; arm is hard very very red and hot to touch; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (vomiting turned to purely vomiting blood) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 003A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included GERD. Concurrent medical conditions included Cervical dystonia and Tremor. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced HAEMATEMESIS (vomiting turned to purely vomiting blood) (seriousness criterion medically significant), MALAISE (did not feel very well), DIARRHOEA (diarrhea), CHEST PAIN (chest pain), TORTICOLLIS (Cervical dystonia and tremors which has gotten visibly worse), TREMOR (Cervical dystonia and tremors which has gotten visibly worse), ERYTHEMA (arm is hard very very red and hot to touch), INDURATION (arm is hard very very red and hot to touch), SKIN WEEPING (arm is hard very very red and hot to touch, oozing in the middle of the night), PYREXIA (progressively ill-er with a temperature 101.2), CHILLS (severe chills) and NAUSEA (nausea). On an unknown date, the patient experienced SKIN WARM (arm is hard very very red and hot to touch). At the time of the report, HAEMATEMESIS (vomiting turned to purely vomiting blood), MALAISE (did not feel very well), CHEST PAIN (chest pain), TREMOR (Cervical dystonia and tremors which has gotten visibly worse), ERYTHEMA (arm is hard very very red and hot to touch), INDURATION (arm is hard very very red and hot to touch), SKIN WARM (arm is hard very very red and hot to touch), SKIN WEEPING (arm is hard very very red and hot to touch, oozing in the middle of the night), PYREXIA (progressively ill-er with a temperature 101.2) and CHILLS (severe chills) outcome was unknown and DIARRHOEA (diarrhea), TORTICOLLIS (Cervical dystonia and tremors which has gotten visibly worse) and NAUSEA (nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature: 101.2 (High) progressively iller. Concomitant medications were not provided. Action taken with m-RNA in respect to the events was not applicable. Per report, On 08-Apr-2021 the patient was admitted to the emergency room (ER). While in the ER, the patient received an EKG, chest x-ray, basic metabolic panel, complete blood count with differentials, hepatic function test, troponin and urinalysis (test results were not provided). Her diagnosis was systemic adverse effect of COVID 19 vaccine. Treatment included Ketorolac, Theraflu (Acetaminophen, Chlorpheniramine, Dextromethorphan, and Pseudoephedrine ), and anti-nausea medications. Company Comment: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Fever, chills and nausea are consistent with the product known safety profile. This case was linked to MOD-2021-073928 (E2B Linked Report).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Fever, chills and nausea are consistent with the product known safety profile. MOD-2021-073928:First dose
64 2021-04-15 chest pain Patient was waiting the recommended 15 minutes after vaccination. Close to the end of the time peri... Read more
Patient was waiting the recommended 15 minutes after vaccination. Close to the end of the time period, patient starting have chest pain. Paramedics were contacted and patient was taken to Hospital by ambulance. Patient was discharged 3 days later on Lovenox therapy for blood clotting. Per the patient, ER physician stated that patient's prognosis would have been much worse had she not been under supervision of pharmacy vaccination staff and taken to hospital by ambulance.
64 2021-04-15 loss of consciousness, hypertension Dizzy, Headache, Body aches, Chills, Cold Sweat and shaking, Nausea, Temporary loss of consciousness... Read more
Dizzy, Headache, Body aches, Chills, Cold Sweat and shaking, Nausea, Temporary loss of consciousness, vomiting,
64 2021-04-15 oxygen saturation decreased nausea, vomiting, diarrhea, fatigued for weeks. pt has has swelling on the left side of her body - s... Read more
nausea, vomiting, diarrhea, fatigued for weeks. pt has has swelling on the left side of her body - swelling went away after 5 weeks
64 2021-04-15 fainting Diarrhea nausea belly pain- I fainted briefly- am fine now. Husband was with me. No medical attentio... Read more
Diarrhea nausea belly pain- I fainted briefly- am fine now. Husband was with me. No medical attention needed. 3 am Could have been good poisoning as well but could have been related to vaccination
64 2021-04-16 chest discomfort, blood pressure increased, palpitations dizzy, red neck and arm. Next day - tired, body aches, headache - lasted 3 days, itchy skin, BP was ... Read more
dizzy, red neck and arm. Next day - tired, body aches, headache - lasted 3 days, itchy skin, BP was elevated, chest heavyness, racing heart all symptoms lasted for 2 to 3 weeks. Seventh day full body rash, neck, ears, chest, arms, legs, swollen right ear and psoriasis was flared up badly.
64 2021-04-16 nosebleed Moderna COVID?19 Vaccine EUA Also had similar adverse reaction to first shot. second shot reaction 4... Read more
Moderna COVID?19 Vaccine EUA Also had similar adverse reaction to first shot. second shot reaction 4/15 insomnia due to pain in arm and overall body pain, fatigue, chills, malaise, headache On 4/16 during the daylight hours -awake 5 hours sleep 1 hour on and off, chills, low normal blood pressure, high normal heart rate, freezing, dizzy, loss appetite, headache, sinus pain, small amount of blood from nose, food smelled terrible, sweating, malaise body pain, muscle pain overall pain and in arms and joints pain. 4/17 slept 6 hours awoke with headache, left knee muscles did not want to work (painful would not take weight, food smells bad, shortness of breath. still small amount of blood from nose, arm pain greatly reduced
64 2021-04-16 fainting The patient received vaccine at the pharmacy and stayed for an observational period of 15 minutes. ... Read more
The patient received vaccine at the pharmacy and stayed for an observational period of 15 minutes. The patient left the pharmacy seeming fine but then reported on 4/17 that she had fainted at her residence and she was taken in an ambulance to a hospital. Patient said that the hospital ruled out a blood clot.
64 2021-04-17 platelet count decreased A rather large bruise/clot developed on the thigh of the patient, the day after receiving her second... Read more
A rather large bruise/clot developed on the thigh of the patient, the day after receiving her second Moderna COVID vaccination; therefore, two days after receiving the second dose of the vaccine, went to the emergency room to get her platelet count checked. The reporter of this form, and her son, was concerned after reading a article titled "A Few Covid Vaccine Recipients Developed a Rare Blood Disorder" and thought it may be ITP (immune thrombocytopenia). While in the emergency room, we asked for a CBC and indeed her PLT Platelet Count was low at 24K. A platelet transfusion or dexamethasone were the treatment options considered. was given 12mg of the medicine and was ordered to take an additional 28mg after picking up the medicine from the pharmacy. After speaking with her primary care doctor, Dr., we agreed to forgo the additional 28mg and wait to see what the results of the subsequent daily blood tests will yield. For the next two days, we got her platelet count checked again and they returned to normal and were 286K and 310K respectively.
64 2021-04-17 ventricular tachycardia 64 year old female with a history of Non-ischemic cardiomyopathy with defibrillator in place. She r... Read more
64 year old female with a history of Non-ischemic cardiomyopathy with defibrillator in place. She received the Moderna Vaccine at clinic on 2/26 and on 3/26 (Lot# 014M20A and 031A21A respectively). She had not received any device therapy for at least one year and had not been hospitalized in over one year. She presented to ED on 3/27 after her defibrillator fired. She was transferred to hospital and evaluated by EP there who felt that ventricular fibrillation prompting defibrillator therapy was triggered by COVID vaccine. After discharge on 3/31, she had another VF episode. On 4/2 admitted awaiting EP consultation. 4/5/21 DISCHARGE SUMMARY STATES: #Recurrent defibrillator therapy in setting of Recurrent VF : AICD interrogation showed underlying rhythm to be Vfib. Possible adverse event associate with vaccine reported to VAERS. Interrogation at emergency department on 3/27 revealed 14 beats of polymorphic V. tach, possible lead misplacement. S per hospital showed lead appropriately positioned. Repeat echocardiogram done at hospital demonstrated an EF of 45 to 49%, device was reinterrogated there. She was seen by EP at that time with recommendations to continue home beta-blocker and follow-up. Upon return to emergency department, cardiology was reconsulted and communicated with EP with recommendation for stopping metoprolol and starting Nadolol 40mg BID and Mexiletine 150 BID. She did not have any further ventricular tachycardia for over 48 hours after this change and was felt safe for discharge home on these two medications.
64 2021-04-19 blood glucose increased Patient arrived to Emergency department of Medical Center 4/18/21 around 5:00 PM and reported that s... Read more
Patient arrived to Emergency department of Medical Center 4/18/21 around 5:00 PM and reported that she had received a COVID vaccine dose #2 at outside clinic a day before this and today is experiencing significant side effects. She presents here with dizziness, headache, myalgias, and urinary incontinence. Around 1:00 PM today she had started to develop body aches, headache, myalgias in the hips, back and arms, chills and sweats. She had a urge to urinate but was unable to get up from reclining due to weakness in her legs and pain when moving. She states it took her an hour to get off the couch and then had difficulty walking due to severe dizziness, and she fell to the floor in her bedroom and fell back and hit the back of her head on the ground but denies any loss of consciousness. She has no visual changes, no nausea or vomiting, no chest pain, no shortness of breath, or hematuria or dysuria, also no numbness in the groin. She states it is painful to move.
64 2021-04-19 chest discomfort, fast heart rate, increased heart rate, low blood oxigenation, fibrin d dimer increased about 10 hours later increased sob and chest tightness and then hypoxia and hospitalization x 4 days... Read more
about 10 hours later increased sob and chest tightness and then hypoxia and hospitalization x 4 days and IV steroids Patient is a 64 y.o. female with PMH notable for von Willebrand disease, asthma, OSA on CPAP, DMT2, HLD, lumbar stenosis, chronic opioid use, GERD, PUD, and anxiety who presents with SOB, weakness, fever. Patient with history asthma, controlled on symbicort and PRN albuterol, now with progressive worsening SOB since the day prior to admission, patient received 2nd dose of Moderna COVID-19 vaccine on 03/10/21. Also, with chest tightness, body aches, headache and chills. Was up last night with fever 101F, took ibuprofen. She had worsening wheezing and SOB while bring dog to dog groomer and had groomer call ambulance. EMS called, received albuterol nebs in route with some improvement in symptoms. Chest tightness has improved. SOB improved now at rest but still winded when up to bathroom. Vitals on arrival notable for BP 144/55, HR 125 (sinus tach on EKG), temp 102.1F, RR 22, 92% on RA. Labs notable for WBC 8.6, CR 0.54. Normal LFTs. Lactate 3.3. D-dimer 0.9. pBNP 56, troponin <0.012. COVID-19 PCR panel negative. CXR with Chronic linear atelectasis or scarring at the lung bases, unchanged. CT PE study negative for PE, possibly some mild pulm congestion, increased interstitial markings. Patient given 2L NS in ED as well as ceftriaxone 2g and doxycycline 100mg. Patient will be admitted to inpatient for further evaluation and management of sepsis. Met sepsis criteria given fever, tachycardia, elevated lactate. Infectious source most likely pneumonia (though only slight increase interstitial markings on CT). Could be atypical or viral pneumonia. However, timing of symptoms could also fit with reaction to COVID-19 vaccine and asthma exacerbation. COVID-19 negative and influenza negative. Was treated with abx for CAP and prednisone + albuterol for asthma exacerbation. Lactate normalized with IVFs, fevers and tachycardia resolved. Patient able to wean to RA, dyspnea and wheezing slowly improved. Abx narrowed to cefzil, doxycycline. 1/2 admission blood cultures positive for streptococcuss. Patient was febrile and septic on admission. Subsequent blood culture without growth to date. Abx returned to IV ceftriaxone given strep + BCx.. Low blood cultures x2 were negative at 48 hours. Dr. was consulted over the phone and he recommended 5 days of oral amoxicillin on discharge. Chronic medical conditions were stable while hospitalized. No medication changes were made.
64 2021-04-19 loss of consciousness Patient was asked how she was feeling before being given the vaccine. She stated her head was hurtin... Read more
Patient was asked how she was feeling before being given the vaccine. She stated her head was hurting. The technician asked if she was sure if she wanted the shot and the patient said yes. She was given the shot, and after approximately 2 minutes she said felt dizzy and fell to the floor. Pharmacist as well the assistant store manager were alerted right away. 911 was called and the AED was retrieved. Patient was unresponsive but breathing with a pulse. Patient regained responsiveness after approximately 3 minutes. EMT arrived and took patient with them.
64 2021-04-19 palpitations Reports heart palpitations, SOB started 4/20/18 Headache, fevers-temp max 100.9 started the day of v... Read more
Reports heart palpitations, SOB started 4/20/18 Headache, fevers-temp max 100.9 started the day of vaccine within a hour Taken Advil Of note: have had palpitations in the past.
64 2021-04-20 blood glucose increased Patient claims "3 days" after vaccination she developed headache that worsened over the next two day... Read more
Patient claims "3 days" after vaccination she developed headache that worsened over the next two days to include dizziness, photophobia, scotomata. However, the state tracking system lists her date of vaccination 10 days prior to the symptom onset. Below is a more detailed description: This is a 64-year-old female nurse practitioner with coronary artery disease, uncontrolled (untreated) type 2 diabetes, obesity, and remote history of kidney donation who presented yesterday with a 5-day history of nausea and frontal headache with new recent dizziness /lightheadedness when standing. She describes her headache as starting out as temporal and periorbital and then persisting as a frontal discomfort radiating to the back and down the neck. Associated with this were complaints of blurry vision, photophobia and scotomata. She denies any focal weakness or numbness/tingling. There was no vomiting or reports of seizures. She denies no recent problems finding words or bouts of confusion. She denies a history of arrhythmia or palpitations. Patient received the first dose of the Moderna COVID-19 vaccination on 4/14/2021 into her right arm, 5 days prior to admission (But state records list 4/7/2021 as the date). She did not take any medication to pre-empt side effects such as NSAID, aspirin, H2 blocker, or Tylenol. Initially she developed a sore arm the night of the vaccination. Three days later the headache developed that did not respond to Tylenol PM although it helped her sleep. She noted taking more than the recommended dose and had mouth dryness. Patient denies any past history of COVID exposure and any illness c/w COVID where she was not tested. She has never had her antibody titer checked. She recently had a dental procedure for an exposed nerve and had a temporary filling placed. No antibiotics were given and denies having a dental abscess She described that one of her sisters developed "blood clots from her heart due to atrial fib" after her Pfizer vaccination. She denies rashes or stigmata of endocarditis, no fevers, chills, or night sweats. She describes vaginal itching a few days ago and self treated with an anti-yeast cream (Monistat) that relieved symptoms and does not currently have dysuria, frequency or urgency. On admission, her UA was abnormal and culture is pending but she received one dose of Rocephin and is still without urinary symptoms. After admission CT scan and MRI of the brain revealed focal areas of likely small subacute embolic infarcts. (See report) Since admission she had a reassuring ECHO and no further worsening. No evidence for A flutter or fib Review of Systems Constitutional: no fever, no chills, no sweats, mild General weakness Skin: no Jaundice, no rash, no lesions, no petechiae ENMT: no ear pain, no sore throat, moderate congestion, no hoarseness Respiratory: no shortness of breath, no cough, no orthopnea, no wheezing Cardiovascular: no chest pain, no palpitations, no edema Gastrointestinal: mild nausea, no vomiting, no diarrhea, no GI bleeding Genitourinary: no dysuria, no hematuria, no discharge, no pain Musculoskeletal: no back pain, no trauma; Some neck discomfort bilaterally R>L Neurologic: moderate headache, mild dizziness, no numbness, mild weakness Psychiatric: mild sleeping problems, no irritability, Describes herself as high strung type A Heme/Lymph: no bleeding tendency, no bruising tendency, no petechiae, no swollen nodes Allergy/Immunologic: moderate seasonal allergies, no food allergies, no recurrent infections, no impaired immunity Additional ROS info: Except as noted in the above Review of Systems and in the History of Present Illness all other systems have been reviewed and are negative or noncontributory Problem List/Past Medical History 1) Uncontrolled diabetes with a hemoglobin A1c greater than 11; She stopped metformin and has tried to control it with diet alone. She does not have a PCP 2) Coronary artery disease with 4 stent placements in 2017; noncompliant with aspirin 3) Hyperlipidemia on Crestor 4) History of kidney donation to her late husband. She reports a stable creatinine 5) Obesity with a BMI of 34.8 Physical Exam Vitals & Measurements T: 36.4 °C (Oral) TMIN: 36.4 °C (Oral) TMAX: 36.5 °C (Oral) HR: 86(Peripheral) RR: 18 BP: 115/72 SpO2: 92% WT: 92.4 kg General: alert, no acute distress Skin: warm, dry Head: no trauma, normocephalic Neck: Trachea midline, no adenopathy, no tenderness; No bruits Eye: normal conjunctiva, sclera clear Cardiovascular: regular rate and rhythm, normal peripheral perfusion. No carotid bruits Respiratory: Lungs CTA, respirations non labored Chest wall: no deformity Gastrointestinal: non distended, Extremities: no deformity, no trauma Neurological: oriented x 4, LOC appropriate for age, CN II-XII intact, motor strength equal & normal bilaterally upper extremity, sensation equal & normal bilaterally, speech normal Psychiatric: cooperative, affect appropriate for age, normal judgement, normal psychiatric thoughts Assessment/Plan This Visit Diagnosis 1. ASB (asymptomatic bacteriuria) R82.71 - No antibiotic treatment recommended - Do not act on pending urine culture 2. Embolic cerebral infarction I63.40 - Unclear source as echo was clear; no stigmata of endocarditis - No carotid study as of yet - She has multiple risk embolic stroke (DM, age, hyperlipidemia, smoking, obesity) - Unclear if COVID vaccine initiated this process (has a low threshold for a cerebral event) - There are no national reports regarding this type of side effect in an mRNA vaccine 3. Adverse effect of viral vaccines T50.B95A - Received COVID Moderna vaccine and symptoms developed 3 days later - Unclear if vaccine cause symptoms 4. Diabetes mellitus E11.9 - Poorly controlled with Hbg over 11 5. Body mass index (BMI) of 38.0 to 38.9 in adult Z68.38 - Current weight 92.4 kg 6. Tobacco use Z72.0 - Small amount 7. H/O unilateral nephrectomy Z90.5 - Creatinine is currently 6.0 Plan: * I will report the possible vaccine adverse event to the national system (VAERS) - This was shared with the patient and she can also file a report - Recommend that the sister also file a VAERS report * Await neurology opinion regarding carotid studies * No further antibiotics since she has no symptoms
64 2021-04-20 chest pain Left arm very swollen, sore and warm to touch. Pain in left arm pit. Headache and general fogginess,... Read more
Left arm very swollen, sore and warm to touch. Pain in left arm pit. Headache and general fogginess, fever +4 degrees from normal baseline temp. Pain in upper chest, breathing deeply brought on more discomfort. Stomach pain upon eating anything. Pain in eyes, hard to describe. Swollen glands in neck. Body aches and extreme fatigue. Took 1000 mg Tylenol with no symptom relief. Severe and acute adverse reactions including fever severe pain in left arm and acute chest pain lasted for 48 hours. Other symptoms continued as noted. 3rd day after vaccine, still had some fatigue, left arm (injection sight) pain still very sore and swollen, chest pain was diminished, armpit pain still present, throat pain/swollen still present, no fever or headache. took 1000mg Tylenol to no avail. No noticeable relief. 4th day after vaccine, left arm still swollen-somewhat painful to touch, swollen throat and pain still present, chest pain-deep breathing still present, arm pit pain still present, fatigue still present.
64 2021-04-20 deep vein blood clot, pulmonary embolism, fast heart rate Presented to the ED on 4/18/21 with tachycardia and shortness of breath. Found to have bilateral DV... Read more
Presented to the ED on 4/18/21 with tachycardia and shortness of breath. Found to have bilateral DVTs and bilateral pulmonary emboli - confirmed with imaging. As a result, was found to have obstructive shock with presumed right heart failure. She received 50mg of systemic TPA along with catheter directed thrombolysis. Remains critically ill in the ICU.
64 2021-04-20 palpitations Heart palpitations. Monitored by EMS. Discharged. Ambulatory.
64 2021-04-20 fast heart rate, palpitations Extreme muscle pain, heart palpitations, tachycardia, fever, chills, nausea, brain fog. I was shaki... Read more
Extreme muscle pain, heart palpitations, tachycardia, fever, chills, nausea, brain fog. I was shaking so badly I could not hold a phone to call 911 and get help, and really my brain was in such a fog I could not think to do so. All I could do is crawl back in bed and pray I didn't die. I've never had a reaction to any vaccine before, and I thought this would actually kill me. This lasted all night, and the next 3 days I was still very weak and sick.
64 2021-04-21 chest pain, palpitations Have been having shortness of breath heart palpitations on annoy limp notes swollen on the left arm ... Read more
Have been having shortness of breath heart palpitations on annoy limp notes swollen on the left arm slight upper chest pain and under the arm and back headaches My stress anxiety has increased....
64 2021-04-21 hypertension Generalized itching, high blood pressure 20 minutes after dose - taken to ER, given benedryl and mon... Read more
Generalized itching, high blood pressure 20 minutes after dose - taken to ER, given benedryl and monitored BP - discharged home 3 hours later, take benedryl as needed and see primary physician for BP spike
64 2021-04-21 pulmonary embolism Patient was admitted to Hospital on 4/12 with shortness of breath and diagnosed with Acute Pulmonary... Read more
Patient was admitted to Hospital on 4/12 with shortness of breath and diagnosed with Acute Pulmonary Embolism .
64 2021-04-22 blood pressure increased, chest pain 1.5 inches below puncture are swelled, turned red, temp at swelling site 102.5. Blood pressure spike... Read more
1.5 inches below puncture are swelled, turned red, temp at swelling site 102.5. Blood pressure spiked to 187/110. Severe chest pain that subsided after laying down 5 minutes. BP dropped to 162/90 but would not go down.
64 2021-04-22 cerebrovascular accident Diagnosed with Bell´s Palsy; Stroke; Second dose scheduled 2 days past her 42 days; terrible dizzin... Read more
Diagnosed with Bell´s Palsy; Stroke; Second dose scheduled 2 days past her 42 days; terrible dizziness; double vision; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and FACIAL PARALYSIS (Diagnosed with Bell´s Palsy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included High cholesterol, Hypertension and Thyroid disorder. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), DIZZINESS (terrible dizziness) and DIPLOPIA (double vision). On 10-Apr-2021, the patient experienced FACIAL PARALYSIS (Diagnosed with Bell´s Palsy) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 2 days past her 42 days). The patient was hospitalized from 28-Mar-2021 to 31-Mar-2021 due to CEREBROVASCULAR ACCIDENT, and then from 10-Apr-2021 to 13-Apr-2021 due to FACIAL PARALYSIS. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), FACIAL PARALYSIS (Diagnosed with Bell´s Palsy), DIZZINESS (terrible dizziness) and DIPLOPIA (double vision) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose scheduled 2 days past her 42 days) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient had a stroke that affected her right side and affected her vision. She stated she had a very mild case of bells palsy, her mouth and her left side was drooping a bit, her left eye did not blink and would not close, she could chew and she could talk pretty good, she had to drink with the right side with a straw. Products known to have been used by the patient, within two weeks prior to the event, included unspecified cholesterol medication, high blood pressure medication and unspecified thyroid medication. Treatment medications included: prednisone, 5 or 6 medications for the heart and valacyclovir HCL 1g tablet. This report refers to a case of Inappropriate schedule of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (stroke, facial paralysis, dizziness, and diplopia), a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (stroke, facial paralysis, dizziness, and diplopia), a causal relationship cannot be excluded.
64 2021-04-22 deep vein blood clot, pulmonary embolism She had the vaccine, felt shortness of breath and fever and chills on 4/16/21. On 4/18/21 she felt ... Read more
She had the vaccine, felt shortness of breath and fever and chills on 4/16/21. On 4/18/21 she felt pain and discomfort on the left leg, and she had left leg DVT and bilateral pulmonary embolisms. Left leg was found on US, and pulmonary embolism was found on 4/22/21 on CT. She has been given Heparin drip and he does not know when she will be released. She is having difficulty breathing, shortness of breath mainly with activity.
64 2021-04-22 haemoglobin decreased, cerebrovascular accident On April 13th, patient noted a black spot in her vision with her right eye. As the day progressed, s... Read more
On April 13th, patient noted a black spot in her vision with her right eye. As the day progressed, she began experiencing a headache which worsened in severity despite treating with medication. She started treating with Tramadol; when that didn't help, she took her prescription oxycodone (5mg/325mg) 3 hours later, q6 hours x 2. That evening, patient experienced 1 episode of emesis and thought she may not be feeling well, so went to bed. When she woke the next morning, she felt better, but still noted the black spot in her vision. She sought care with her Ophthalmologist, who evaluated her, and he did not believe it was related to her vision. He referred her for an MRI, immediately. MRI revealed a stroke in the occipital region. She was admitted and given IV fluid along with another panel of testing. She was seen by Neurologist and Hospitalist; more testing was completed on Friday, including bloodwork which revealed high potassium levels which was treated. She was also given 1 unit of blood. She discharged on Friday and was started on Clopidogrel (75 mg). Follow up appointments are scheduled with eye doctor, neurology, internist. Right eye was affected and vision will not likely return, per her doctors.
64 2021-04-22 blood clot, cerebrovascular accident I because confused and unsteady. I then fell. My husband helped me up but he knew something was wr... Read more
I because confused and unsteady. I then fell. My husband helped me up but he knew something was wrong. He called 911 an ambulance took me to the hospital but I was transferred to another hospital. In case I needed surgery. It was touch and go. I was suffering a stroke. A blood clot was also found. I was in the hospital ICU for 3 days then transferred to another room. For another day.
64 2021-04-23 heart rate increased, atrial fibrillation Elevated heart rate, causing Afib
64 2021-04-23 loss of consciousness Second dose of Moderna vaccine 4-01-21 at 3:00pm.At 2:30 am high fever 39C walk me up,chills and big... Read more
Second dose of Moderna vaccine 4-01-21 at 3:00pm.At 2:30 am high fever 39C walk me up,chills and big headache. 4-03-21 fills little better but waking up every day with headache. 4-06-21 took half a day off from work because of a big headache. 4-07-21 morning lost speech ability and lost my consciousness. My husband call 911. they are taking me to a hospital I regain my consciousness and speech 2 days later. Diagnosis -Viral brain infection. Stayng in the hospital 7 days still every day with a big headache.
64 2021-04-23 fainting Diarrhea vomiting fainting
64 2021-04-25 chest pain, blood pressure increased Had typical adverse effects with 1st dose, which lasted approximately 36 hrs; however, with this dos... Read more
Had typical adverse effects with 1st dose, which lasted approximately 36 hrs; however, with this dose had not only extremely red area in arm, rashes on interior of arm, diarrhea, nausea, headache, chills, fever, exhaustion, also had chest pain, vomiting and ultimately vomiting blood,, which led to ER visit elevated wbc, blood in urine, basic metabolic Panel, CBC and Differential, Hepatic Function Panel, Tropinin 3 hr, baseline, & serial, ECG, XRay, raised blood pressure, IV and toradol and phenergan diagnosis@ ER systemic adverse effect of COVID-19 vaccine
64 2021-04-25 hypertension After the vaccine was administered to me, I felt dizzy and weak, difficulty breathing, my body swell... Read more
After the vaccine was administered to me, I felt dizzy and weak, difficulty breathing, my body swells up, my pressure went up to 215/190. On site ambulance on site was called to monitor my pressure. I took Amlodipine. I stayed on the site for 2 hours and when my pressure went down to 195/185, I left the site and went home. At home I felt weak and dizzy the entire day and night. The doctor at the vaccination site called my home and spoke to me to make sure I got home safe.
64 2021-04-25 pulmonary embolism, superficial blood clot, deep vein blood clot MULTIPLE BILATERAL PULMONARY EMBOLI NONOCCLUSIVE RIGHT POPLITEAL DVT OCCLUSIVE RIGHT POSTERIOR TIBIA... Read more
MULTIPLE BILATERAL PULMONARY EMBOLI NONOCCLUSIVE RIGHT POPLITEAL DVT OCCLUSIVE RIGHT POSTERIOR TIBIAL VEIN AND RIGHT SMALL SAPHENEOUS VEIN THROMBOSIS PATIENT BEGAN TO DEVELOP LEFT FLANK PAIN FOUR DAYS FOLLOWING VACCINATION FOLLOWED BY SEVERE SHORTNESS OF BREATH WITHIN THE FOLLOWING DAYS
64 2021-04-26 heart rate increased, hypotension ear ringing, heADACHE, SORE ARM, dizziness and fatigue, legs felt heavy, dizziness, fast pulse, low ... Read more
ear ringing, heADACHE, SORE ARM, dizziness and fatigue, legs felt heavy, dizziness, fast pulse, low blood pressure, chills
64 2021-04-28 chest discomfort, chest pain Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficu... Read more
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: body shaking, body sweats and chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: pt experienced severe fatigue that has not resolved. she experienced breakouts in chills and shakiness
64 2021-04-28 palpitations, blood pressure increased 12 hours later woke to feeling as cold as I have ever been in my life. Felt "fluish" for next day. ... Read more
12 hours later woke to feeling as cold as I have ever been in my life. Felt "fluish" for next day. Following day felt strange and began having palpitations of the heart. I have never had palpitations before. Bought a blood pressure cuff and blood pressure 160/92. I have never had hypertension. Palpitations worsened over next several days. Palpitations made me feel awful. Palpitations persisted on and off for days. Elevated blood pressure on and off over next week also. Weather wad bad, I was out of town and I was unable to get to the doctor right away. Saw cardiologist 2/18/21.
64 2021-04-29 chest pain, chest discomfort Pt vaccinated with Moderna (first dose) and was awaiting alongside the booth standing up and within ... Read more
Pt vaccinated with Moderna (first dose) and was awaiting alongside the booth standing up and within a minute felt dizzy and was short of breath. Son at her side and assisted her to walk over to observation and felt weak all over, extremities and assisted in the wheelchair. Complained of chest pain/pressure. EMS called and brought to ED. In ED, EKG normal. Trops 0.1, 0.04 then 0.01. Exercise Stress test normal Discharged to home with PCP followup.
64 2021-04-29 hypertension, chest pain, chest discomfort time for the shot, walked to the chair to wait; started back of tongue could be felt on both sides o... Read more
time for the shot, walked to the chair to wait; started back of tongue could be felt on both sides of my month rubbing my teeth. Sat waiting 15 minutes, time to leave, explained to staff, Seen immediately, given 2 doses of ligiid Benadryl. while talking with staff noticed from on tongue numb, them face and left hand fingers went numb, blood pressure elevated. Taken to the ER, given IV and monitored. given methyIPREDNISolne through IV.; sent home later with 3 days of predniSONE and 5 days diphenhydrAMINE . Next 2 days had ; headaches, talked with my General GP, started Tylenol and Pepcid ; by Sunday having chest pain and tightness, used Albuterial HFA 200 meter, relieve tightness, happened again on Monday - did not sleep till 4 AM; Saw GP on Tuesday, test ordered,
64 2021-04-29 hypertension Patient started to feel very ill 8 days after receiving her first vaccination. Symptoms were nausea,... Read more
Patient started to feel very ill 8 days after receiving her first vaccination. Symptoms were nausea, dizziness, BP was 200/100. She went to the ED and was admitted for stroke protocol. Her blood pressure remained high for a few days and was started on Norvsac in the hospital. She has been following up with a cardiologist.
64 2021-04-30 chest discomfort little Sore Arm; Pressure on the Chest; could not breath; This spontaneous case was reported by a pa... Read more
little Sore Arm; Pressure on the Chest; could not breath; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (could not breath) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy NOS (Patient is feeling fatigue and tired due to allergies.). On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DYSPNOEA (could not breath) (seriousness criterion medically significant) and CHEST DISCOMFORT (Pressure on the Chest). On an unknown date, the patient experienced PAIN IN EXTREMITY (little Sore Arm). On 31-Mar-2021, DYSPNOEA (could not breath) and CHEST DISCOMFORT (Pressure on the Chest) had resolved. At the time of the report, PAIN IN EXTREMITY (little Sore Arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
64 2021-05-02 hypotension Pt presented with abd pain, hypotension, significant colitis on CT scan about 9-10 days after vaccin... Read more
Pt presented with abd pain, hypotension, significant colitis on CT scan about 9-10 days after vaccination
64 2021-05-02 loss of consciousness At 2:30 in the morning I woke up to go to the bathroom. On the way back to bed I fell. My husband ... Read more
At 2:30 in the morning I woke up to go to the bathroom. On the way back to bed I fell. My husband hear me fall and came out. I was unconscious. When he tried to get me to our room, I had a seizure. He called 911 This was all a matter of 2 minutes total. I have never had one before. I am in good health. My BP was 92/ 65 when paramedics arrived. It is normally 110/ish/60ish. Paramedics thought perhaps I was dehydrated.
64 2021-05-02 low platelet count Thrombocytopenia. No bruising or symptoms stated since last dose of vaccine on 01/27/2021. Patient j... Read more
Thrombocytopenia. No bruising or symptoms stated since last dose of vaccine on 01/27/2021. Patient just went for annual labs and discovered it. Experienced Dry. crusty rash on body. Patient is on high-dose corticosteroid therapy. Patient seeing Hematologist.
64 2021-05-03 loss of consciousness PATIENT WAS ADVISED AFTER RECEIVING VACCINE TO SIT FOR 15 MINUTES. SHE THEN SAID SHE NEEDED TO GO T... Read more
PATIENT WAS ADVISED AFTER RECEIVING VACCINE TO SIT FOR 15 MINUTES. SHE THEN SAID SHE NEEDED TO GO TO THE BATHROOM. PERSON WATCHING HER SAID THIS IS OK, BUT SHE WOULD ESCORT PATIENT. PT THEN PASSED OUT ON THE WAY TO RESTROOM, BUT WAS CAUGHT BY PERSON WATCHING HER AND LAID TO THE GROUND. HER FEET WERE ELEVATED AND SHE WOKE UP WITHING A FEW SECONDS. HER MASK WAS REMOVED AND SHE WAS ALLOWED TO LAY DOWN A FEW MINUTES, THEN WAS SLOWLY BROUGHT BACK TO A SITTING POSITION, THEN EVENTUALLLY UP TO HER FEET AND TO THE BATHROOM, THEN BACK TO HER CHAIR TO SIT. SHE THEN SAT ANOTHER 25 MINUTES.
64 2021-05-04 cerebrovascular accident Received Moderna vaccine, 2nd dose 4/19/2021. On 4/24.2021 experienced a stroke . Pt awoke morning... Read more
Received Moderna vaccine, 2nd dose 4/19/2021. On 4/24.2021 experienced a stroke . Pt awoke morning of 4/24/2021 with "severe vertigo and vomiting".
64 2021-05-05 heart rate increased Heart beating rapidly; Headache; Lingering migraine so had to go to emergency room after first dose;... Read more
Heart beating rapidly; Headache; Lingering migraine so had to go to emergency room after first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Lingering migraine so had to go to emergency room after first dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for Sleep deprivation. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MIGRAINE (Lingering migraine so had to go to emergency room after first dose) and HEADACHE (Headache). On 01-Apr-2021, the patient experienced HEART RATE INCREASED (Heart beating rapidly). On 01-Apr-2021, HEART RATE INCREASED (Heart beating rapidly) had resolved. On 02-Apr-2021, MIGRAINE (Lingering migraine so had to go to emergency room after first dose) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Blood test: (normal) normal. On 01-Apr-2021, Electrocardiogram: (normal) normal. On 01-Apr-2021, Heart rate: (High) Heart beating rapidly. On 01-Apr-2021, Liver function test: (normal) normal. On 01-Apr-2021, Pulmonary function test: (normal) normal. On 01-Apr-2021, Renal function test: (normal) normal. On 01-Apr-2021, SARS-CoV-2 test: (Negative) Negative. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. The patient after receiving their first dose of vaccine experienced extreme reactions and ended up going to the emergency room where they gave the patient an injection cocktail for their headache. The patient said it helped but the headache came back the next day for a total of 3 days and also reported a migraine for 3 days and their heart was beating rapidly. The patient undergone several tests which included lung test, electrocardiogram (EKG), blood test, liver, and kidney levels. All the test results appeared to be normal. The patient was also tested for COVID-19 and the result was negative. Treatment medication for the event headache included injection cocktail. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded This case was linked to MOD-2021-100742 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
64 2021-05-07 chest discomfort 1350 - tightness in chest, right side, started 3 minutes after receiving 2nd dose moderna vaccine, r... Read more
1350 - tightness in chest, right side, started 3 minutes after receiving 2nd dose moderna vaccine, radiating to right shoulder/back. BP 180/85 SATS 97%, pulse 73. 1400 - Pt with husband in car, reports to start feeling better, water given,patient re recheck 140/85 refused EMS service, will continue to monitor patient. 1413 - B/P 140/ 85 patient and spouse instructed to go to ER or call 911 if symptoms change or increase
64 2021-05-09 cerebrovascular accident, blood glucose increased Headaches, Blurred eye-site, Exhausted! Went to Urgent Care 1/30/21 did Covid test again gave me st... Read more
Headaches, Blurred eye-site, Exhausted! Went to Urgent Care 1/30/21 did Covid test again gave me steroids. Went to GP March 7. did blood work. Gave me stronger antibiotics and more steroids. Feb 11-13 in Hospital. Taken by ambulance to ER. BP was 195/100 heart rate 120. Had high blood counts on many things! Sugar levels high for 5 days. 145-165 usually normal. ER doctors suggested I see a Neurologist. I had a mild stroke in right Occipital lobe. Went to Clinic on March 1. Prelim appt. Checking on Chiari Malformation mostly. April 1-2 Clinic. Botox in head for migraine headaches. Diclofenac Sod 50 mg & Cyclobenzaprine 10 mg. I'm still very weak/exhausted, eyes blurry and feel swollen and memory is awful with shaking in hands. Saw Eye specialist, I have 20/20 vision. I haven't been able to work since Jan 23, 2021. I can't drive and am having a tough time with remembering anything.
64 2021-05-09 heart rate increased fever 104 degree, trouble breathing, swelling on arm ,upper neck, chest, feeling weak and dizzy , fa... Read more
fever 104 degree, trouble breathing, swelling on arm ,upper neck, chest, feeling weak and dizzy , fast heartbeat, blood pressure 200/110 lasted for 24 hours
64 2021-05-09 hypertension After 15 minute observation period, patient got up to walk to the front of the clinic and felt dizzi... Read more
After 15 minute observation period, patient got up to walk to the front of the clinic and felt dizziness. She was unable to stand up due to dizziness. Vitals were taken, patient was hypertensive, HR in the 80s, pulse Ox was over 96%. Ambulance was called and patient taken to ER for evaluation.
64 2021-05-09 hypertension One month post vaccine, I had yearly physical with my primary physician. My BP was notably high. D... Read more
One month post vaccine, I had yearly physical with my primary physician. My BP was notably high. Dr. asked me to repeat at home. After 3 weeks still high. He increased Lisinipril from 5mg to 10 mg, no change. Called my cardiologist, who then increased lisinipril to 20mg, still no change. Pressure remains around 153/90. With the small dose of bystolic and lisinipril, I've maintained a pressure of 120/80 for years. The same thing happened to my husband after his vaccine. His pressure has always been around 120/75. Now it's averaging 155/90
64 2021-05-09 palpitations Lightheadedness and pounding heart about 8 minutes after receiving second dose. The pounding heart ... Read more
Lightheadedness and pounding heart about 8 minutes after receiving second dose. The pounding heart went away about an hour after receiving vaccine. This did not feel like a panic attack. Nothing I did (slow breathing, drinking water, sitting on the couch) would help. But then after about an hour it just stopped. Still having lightheadedness, nausea and diarrhea on May 10th. The lightheadedness sometimes goes away but keeps coming back. I can't drive or walk very far because of it. Also very hard to concentrate. Found many other people having the same symptoms after the vaccines.
64 2021-05-11 haemoglobin decreased Pt. presented to our ED non-verbal and could not contribute to her hx. Pt. had fever of 99.3, WBC of... Read more
Pt. presented to our ED non-verbal and could not contribute to her hx. Pt. had fever of 99.3, WBC of 0.4, Hbg of 8.2, HR 140, BP 79/44, Lactic acid of 2.7, O2 sat. of 86% RA requiring 3L, Pt. received IV fluids, dose of Amiodarone 150 mg, placed on Levophed drip, blood cultures were obtained- showing no growth, Covid test- PCR was negative. Pt. had a not from cancer physician for pallative cares on 4/19/2021. Husband reports pt. wanting to be a full code. Pt. with diagnosis of Septic shock was transferred to hospital of higher care in area. Please note that pt. had received her first Covid vaccine 03/09/2021 - lot # 026A21A. Database reports patient could have possibly received a Johnson and Johnson vaccine on 3/17/2021, but no information available such as lot number or where pt. possibly obtained vaccine from. Then pt. received Covid shot #2 on 4/6/2021.
64 2021-05-11 troponin increased Patient presented to ED on 5/3/21 for shortness of breath, diarrhea, and bloody bowel movements, Pa... Read more
Patient presented to ED on 5/3/21 for shortness of breath, diarrhea, and bloody bowel movements, Patient does not occasional cough. Patient diagnosed with COVID -19 infection and GI bleed. Patient did have elevated troponins on admission attributed to demand ischemia from COVID-19 pneumonia and acute GI bleed. COVID-19 infection was treated with remdesivir, oxygen and steroids. Patient improved and was later discharged to home.
64 2021-05-12 chest discomfort Client felt dizzy and tightness in chest. Similar reaction after first dose and she said it lasted 2... Read more
Client felt dizzy and tightness in chest. Similar reaction after first dose and she said it lasted 24 hrs. She called doctor before this dose and is to call when she gets home. POX 98, BP 146/86, HR 66 She waited 30 minutes and said she was ok to walk out and would sleep at home .
64 2021-05-12 chest discomfort General Fatigue Muscle aches Sore throat Loss of appetite Headache Scratchy throat Chest pressur... Read more
General Fatigue Muscle aches Sore throat Loss of appetite Headache Scratchy throat Chest pressure Going on five days now...
64 2021-05-12 excessive bleeding She was found dead in her home one week after the injection. She died the day of the injection accor... Read more
She was found dead in her home one week after the injection. She died the day of the injection according to the coroners office. There was blood on the bed and down her chest.
64 2021-05-12 fast heart rate Episode of PSVT
64 2021-05-13 chest discomfort, hypertension Administration Comments: Patient observed for 15 minutes then notified RN that she was starting to f... Read more
Administration Comments: Patient observed for 15 minutes then notified RN that she was starting to feel a tingling sensation on her tongue at 1717. Called provider and had MA bring vitals cart to conference room. PA presented to room. MA Sup brought vitals cart. BP at 1717 was 201/78 with a pulse of 58 and an O2 of 97. Patient states only her tongue is tingling. Denies SOB, chest pain, nausea/vomiting, trouble swallowing, vision changes or dizziness at this time. Had patient take her mask off and gave patient water. Patient denies feeling anxious but did run over to vaccine clinic for extra available dose of vaccine from across the street to receive vaccine. Patient appears flushed. States it is the end of tax season and she has been a little more stressed. Hx of COVID infection on 10/31/2020. Repeat BP at 1724, BP was 194/95, O2 99%, pulse 55. States it is only the sides of her tongue that feels tingly at this time. Denies hx of HTN, hx of anxiety. At 1726, states she is starting to feel tightness in her chest. States her tongue is getting better, is still oriented and talking. PA assessing patient. PA left at 1729 and requested that patient be observed for 30 more minutes. RN continues to stay with patient. Rechecked BP at that time and switched to R side for BP cuff, BP 203/83, pulse 58. Had MA get stethoscope. Assessed lungs and heart. Lungs sound clear bilaterally. Heart rate is regular. Radial pulses are present and regular. At 1735, patient states less chest tightness but now feels shaky. States she gets shaky when she goes through a high stress time. RN sat and talked with patient. Patient states she does feel like she was feeling a little anxious and worried of the unknown. Feels less tingling on her tongue now, just near the back near her molars. Denies dizziness, nausea/vomiting, numbness/tingling, vision changes, HA, chest pain, SOB, trouble swallowing. Pulse 54 per radial pulse. At 1750, BP 194/80, tightness gone, tingling improved. Denies any other symptoms at this time. Patient had been observed for 55 minutes after initial injection, provider back into room and assessed again. Plan for patient to follow up with her primary care provider within the next week. Reviewed signs and symptoms of when to seek ER care. Patient states her husband has a BP cuff at home and will check her BP daily. If she continues to have high BP, will go in to be seen sooner. If experiencing sypmtoms, will go to ER. Walked with patient to front door. Patient states she is still feeling good. Patient left building at 1800.
64 2021-05-17 loss of consciousness, chest pain Passing Out, Loss Of Voice, Throat Closing Up, Can Not Breath, Chess and Body Pains, Headaches, Face... Read more
Passing Out, Loss Of Voice, Throat Closing Up, Can Not Breath, Chess and Body Pains, Headaches, Face Swelling, Face Red
64 2021-05-17 fainting I woke with stuffy nose,sinus pain, bad headache, ans fever, arm sore. Pulse 120 Fever 102-100. , ... Read more
I woke with stuffy nose,sinus pain, bad headache, ans fever, arm sore. Pulse 120 Fever 102-100. , I checked my heart rate with Pulse Oxyimiter. My blood pressure around 2:30 was 140 over 90. I took a cold shower, drank 70 ounces of water during day. Took 2 Tylenol , 3:00 and 10:30. Also allergy med which was Bromelain, stinging nettles, Quercia in. 10:30 am and midnight. Also cup of ginger and cinnamon teas. By midnight temp at 100. Heart rate around 81-83. Next day fever down, slight lightheaded ness, very faint head pain, little sinus irritation, heart rate 78 - 68by 11:00pm. No fever.
64 2021-05-17 blood clot, nosebleed Sever headache beginning about 10 hours after vaccination, with nausea, and passed blood clots throu... Read more
Sever headache beginning about 10 hours after vaccination, with nausea, and passed blood clots through nose about 16 hours following vaccine with small further amounts on May 15. All accompanied by extreme fatigue. It was the passing of blood through my nose that was unexpected and seemed worth reporting.
64 2021-05-19 heart rate increased, arrhythmia After 2 weeks later she diagnosed with heart arrhythmia; Patient heart rate was 205 and doctor does ... Read more
After 2 weeks later she diagnosed with heart arrhythmia; Patient heart rate was 205 and doctor does not want it go over 100; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (After 2 weeks later she diagnosed with heart arrhythmia) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication. On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (After 2 weeks later she diagnosed with heart arrhythmia) (seriousness criteria hospitalization and medically significant) and HEART RATE INCREASED (Patient heart rate was 205 and doctor does not want it go over 100). At the time of the report, ARRHYTHMIA (After 2 weeks later she diagnosed with heart arrhythmia) and HEART RATE INCREASED (Patient heart rate was 205 and doctor does not want it go over 100) outcome was unknown. Serious event as per Important medical event terms list (version 24.0) DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 205 (High) Patient heart rate was 205 and doctor does not want it go over 100.. Treatment for the heart arrhythmia included alprazolam. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable. Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
64 2021-05-19 fast heart rate Moderna COVID-19 Vaccine EUA: one day after immunization patient admitted to hospital for weakness a... Read more
Moderna COVID-19 Vaccine EUA: one day after immunization patient admitted to hospital for weakness and confusion. Patient tachycardic but afebrile. Diagnosed with urinary tract infection, administered antibiotics and intravenous fluids, clinically improved and discharged home medically stable.
64 2021-05-22 palpitations I began having skipped heart beats 5 days after receiving the covid vaccine from Moderna. I have ne... Read more
I began having skipped heart beats 5 days after receiving the covid vaccine from Moderna. I have never had these before this time and I continue to have them almost everyday.
64 2021-05-22 blood clot 1 week after receiving the shot the patient was diagnosed with clots and prescribed Eliquis.
64 2021-05-23 palpitations Patient stated that later the same evening after she received her second Moderna Covid vaccine her h... Read more
Patient stated that later the same evening after she received her second Moderna Covid vaccine her heart began racing. She IS treated for high blood pressure but this racing was not a normal feeling for her. She reports that intermittent racing continues to this day. I advised she see her physician and she has an appointment scheduled for June 2.
64 2021-05-24 blood pressure increased We gave her the shot in her right deltoid and after a couple minutes sitting in the waiting room she... Read more
We gave her the shot in her right deltoid and after a couple minutes sitting in the waiting room she felt itchiness in her face. I administered 1ml of diphenhydramine (50mg/ml) into her left arm and monitored her (including BP which was slightly elevated at 155/94). After a few minutes she reported feeling less itchy and starting to improve. We continued to monitor her for 30 min. She stated that she felt better at that time. We checked her BP and breathing one last time and then let her go.
64 2021-05-24 chest pain, hypertension, palpitations, inflammation of the pericardium, chest discomfort Possible pericarditis; Tight chest; Sore throat; Chest pain; Sinus bradycardia; Laryngitis; Hyperten... Read more
Possible pericarditis; Tight chest; Sore throat; Chest pain; Sinus bradycardia; Laryngitis; Hypertension; Hoarseness/Hoarse voice/Loss of voice; Throat swelling; Palpitation; Shortness of breath; Burning sensation; This spontaneous case was reported by a physician and describes the occurrence of PERICARDITIS (Possible pericarditis) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Gastritis on 17-Apr-2020, Trigeminal neuralgia and Obstructive sleep apnea syndrome. Concurrent medical conditions included Hypertension, Hyperlipidemia since 21-Jul-2015, GERD since 31-Mar-2020 and Drug allergy (History of intolerance to multiple medications. Blood pressure test kit-adult extra large cuff.). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), LORATADINE (CLARITIN [LORATADINE]), COLCHICINE (MITIGARE) and OSELTAMIVIR PHOSPHATE for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Palpitation), DYSPNOEA (Shortness of breath) and BURNING SENSATION (Burning sensation). On 21-Jan-2021, the patient experienced DYSPHONIA (Hoarseness/Hoarse voice/Loss of voice). In February 2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Chest pain), SINUS BRADYCARDIA (Sinus bradycardia), LARYNGITIS (Laryngitis) and HYPERTENSION (Hypertension). On an unknown date, the patient experienced PERICARDITIS (Possible pericarditis) (seriousness criterion medically significant) and CHEST DISCOMFORT (Tight chest). In February 2021, PERICARDITIS (Possible pericarditis), CHEST DISCOMFORT (Tight chest), DYSPHONIA (Hoarseness/Hoarse voice/Loss of voice), PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Palpitation), DYSPNOEA (Shortness of breath), BURNING SENSATION (Burning sensation), OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Chest pain), SINUS BRADYCARDIA (Sinus bradycardia), LARYNGITIS (Laryngitis) and HYPERTENSION (Hypertension) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Electrocardiogram: normal (normal) normal. In January 2021, Oxygen saturation: 98-99 (normal) 98-99. In January 2021, Physical examination: normal (normal) normal. On 17-Feb-2021, Blood pressure measurement: 149/62. On 17-Feb-2021, Chest X-ray: normal. On 17-Feb-2021, Electrocardiogram: Showed sinus bradycardia. On 17-Feb-2021, Heart rate: 59 (Inconclusive) 59. On 17-Feb-2021, Heart sounds: (normal) Regular rate and rhythm with normal S1 and S2. No murmur, pericardial rub.. On 17-Feb-2021, Physical examination: normal (normal) normal. On 24-Feb-2021, Blood pressure measurement: 130/58. On 24-Feb-2021, Heart rate: 53 (Inconclusive) 53. On 24-Feb-2021, Heart sounds: (normal) Regular rate and rhythm with normal S1 and S2. No murmur, pericardial rub.. On 03-Mar-2021, Blood pressure measurement: 133/54. On 03-Mar-2021, Heart rate: 61 (Inconclusive) 61. On 03-Mar-2021, Heart sounds: Regular rate and rhythm with normal S1 and S2. No murmur, pericardial rub.. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PERICARDITIS (Possible pericarditis), CHEST DISCOMFORT (Tight chest), DYSPHONIA (Hoarseness/Hoarse voice/Loss of voice), PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Palpitation), DYSPNOEA (Shortness of breath), BURNING SENSATION (Burning sensation), OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Chest pain), SINUS BRADYCARDIA (Sinus bradycardia), LARYNGITIS (Laryngitis) and HYPERTENSION (Hypertension) to be probably related. Treatment for the event included antibiotics, prednisone and colchicine. Medical Clinic Coordinator provided events were resolved in mid Feb 2021 with residual effects of hoarseness and tightness of chest. Company comment Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities, further information required. This case was linked to MOD-2021-046995 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Vaccine adverse event reporting form and medical records received. Multiple fields updated.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities, further information required.
64 2021-05-24 heart rate increased feels like had seizure; delirious; head swelled up like a pumpkin/face, neck, hand swelling; Bloated... Read more
feels like had seizure; delirious; head swelled up like a pumpkin/face, neck, hand swelling; Bloated; migraine headache in half of head; injection site hot, hard, pink, swollen bigger than a deck of cards; brain fog; GI system feels like 100 bottles of hot sauce; GI system felt like 100 bottles of hot sauce; No appetite; shortness of breath; fast heartbeat; injection site hot, hard, pink, swollen bigger than a deck of cards; injection site hot, hard, pink, swollen bigger than a deck of cards; injection site very red; nausea; fatigue; face, upper chest, and arms turned pinkish; fever; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (feels like had seizure) and DELIRIUM (delirious) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (feels like had seizure) (seriousness criterion medically significant), DELIRIUM (delirious) (seriousness criterion medically significant), SWELLING (head swelled up like a pumpkin/face, neck, hand swelling), ABDOMINAL DISTENSION (Bloated), MIGRAINE (migraine headache in half of head), VACCINATION SITE WARMTH (injection site hot, hard, pink, swollen bigger than a deck of cards), FEELING ABNORMAL (brain fog), ABDOMINAL DISCOMFORT (GI system feels like 100 bottles of hot sauce), FUNCTIONAL GASTROINTESTINAL DISORDER (GI system felt like 100 bottles of hot sauce), DECREASED APPETITE (No appetite), DYSPNOEA (shortness of breath), HEART RATE INCREASED (fast heartbeat), VACCINATION SITE INDURATION (injection site hot, hard, pink, swollen bigger than a deck of cards), VACCINATION SITE SWELLING (injection site hot, hard, pink, swollen bigger than a deck of cards), VACCINATION SITE ERYTHEMA (injection site very red), NAUSEA (nausea), FATIGUE (fatigue), RASH (face, upper chest, and arms turned pinkish) and PYREXIA (fever). At the time of the report, SEIZURE (feels like had seizure), DELIRIUM (delirious), SWELLING (head swelled up like a pumpkin/face, neck, hand swelling), ABDOMINAL DISTENSION (Bloated), MIGRAINE (migraine headache in half of head), VACCINATION SITE WARMTH (injection site hot, hard, pink, swollen bigger than a deck of cards), FEELING ABNORMAL (brain fog), ABDOMINAL DISCOMFORT (GI system feels like 100 bottles of hot sauce), FUNCTIONAL GASTROINTESTINAL DISORDER (GI system felt like 100 bottles of hot sauce), DECREASED APPETITE (No appetite), DYSPNOEA (shortness of breath), HEART RATE INCREASED (fast heartbeat), VACCINATION SITE INDURATION (injection site hot, hard, pink, swollen bigger than a deck of cards), VACCINATION SITE SWELLING (injection site hot, hard, pink, swollen bigger than a deck of cards), VACCINATION SITE ERYTHEMA (injection site very red), NAUSEA (nausea), FATIGUE (fatigue), RASH (face, upper chest, and arms turned pinkish) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not given. Action taken was not applicable as patient completed both the doses. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.
64 2021-05-24 heart rate increased After receiving the 1st vaccine symptoms experienced were numbness of mouth/tounge, severe shortness... Read more
After receiving the 1st vaccine symptoms experienced were numbness of mouth/tounge, severe shortness of breath, fatigue, and rapid heart rate. A couple of days later she experienced headache, soar muscles. About a week later, she was not able to walk properly, trouble breathing, coughing, and rapid heart rate. About half an hour later after receiving the 2nd vaccine on 04/30/2021 patient began experiencing rapid heart rate, severe shortness of breath and fatigue.
64 2021-05-25 oxygen saturation decreased, heart rate increased fever of 102 high heart rate(140-170) low o2 stats (79-84)am on oxygen 3 liters could not stay awake... Read more
fever of 102 high heart rate(140-170) low o2 stats (79-84)am on oxygen 3 liters could not stay awake hard time for family to wake me and exhaustion. temp lasted 4 days the other symptoms about 6 days
64 2021-05-25 palpitations 2 days after vaccination, had fatique, A few days later, body tremors and shortness of breath. A few... Read more
2 days after vaccination, had fatique, A few days later, body tremors and shortness of breath. A few weeks later, after sinus surgery, had 12 pound weight loss, rash, palpitations, tremors . Had abnormal bloodwork, was ordered by dermatologist for rash, then referred me to my internist, who tested thyroid and diagnosed with hyperthyroidism. He referred me to endocrinologist who ran more tests and diagnosed me with Graves Disease. Am on Propranolol and Tapazole and am being monitored by endo
64 2021-05-25 palpitations 4/1: Woke up very sick fatigued, dizzy, sweaty, in bed for 24 hours. 4/2: aforementioned symptoms ... Read more
4/1: Woke up very sick fatigued, dizzy, sweaty, in bed for 24 hours. 4/2: aforementioned symptoms improved and could get out of bed but dizzy and ?off? feeling persisted 4/6: increased dizziness throughout day to point fell when walking out of work (did not follow up with blood pressure or anything at this point). 4/16: Dizziness and ?off? feeling continued to progress over past 10 days snd fell when bringing in the groceries. 4/17: woke up feeling heart palpitations when at rest in much. Also much more dizzy to point where could not walk also. Husband recommended taking BP which measure 178. Called PCP who recommended go to hospital. Admitted to hospital and BP erratic. Performed nuclear stress test which was negative and prescribed losartan 25 MG did a nuclear stress test 4/18: discharged from hospital and proceeded to take BP three times a day. Values continued to be erratic also still feeling dizzy (to a lesser extent thought) Approx 5/3: called the doctor to inform of continued erratic BP. He prescribed a new blood pressure medicine- LISINOPRIL 10 MG?s. Despite medication change Bp remained erratic and dizziness persisted 5/18: dizzy woke up on dizzy similar to presentation 4/17 blood pressure 159/98. Proceeded to work and dizziness progressed to point where almost passed out and had to lay head on desk. EMS was called and BP measuring 169. Admitted to hospital took off BP medication and Echocardiogram, CT and MRI of brain all performed- all negative. BP running lower than normal at certain points during hospitalization (as low as 109). Cardiologist prescribed medication for low blood pressure and dizziness (have not filled this medication) 5/20- 5/22: (discharged from hospital) dizziness still more than normal and BP still up and down but better than prior to hospitalization 5/23- current: dizziness but not limiting function and BP remains erratic but still lower than prior
64 2021-05-26 chest discomfort Rash, Hives, difficulty breathing and chest tightness.
64 2021-05-26 deep vein blood clot Acute deep vein thrombosis of femoral vein of right lower extremity.
64 2021-05-26 loss of consciousness Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Pt was asleep/unconcio... Read more
Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Pt was asleep/unconcious in the chair while waiting for the 15 minute wait period. Pt stated that she was unable to lift her arms or walk. She stated that it was difficult to talk. Pt stated that she was not having trouble breathing during this time.-Severe, Additional Details: Due to the patients symptoms, the pharmacy staff contacted EMS who arrived at the pharmacy to treat the patient.
64 2021-05-26 troponin increased, palpitations, fibrin d dimer increased On 5/7, she developed fatigue, chills, palpitations. She felt unwell and presented to the ED on 5/1... Read more
On 5/7, she developed fatigue, chills, palpitations. She felt unwell and presented to the ED on 5/12.
64 2021-05-26 blood vessels inflammation I received my first vaccine 01-17-2021. I have history of rare autoimmune disease, flared up. PT use... Read more
I received my first vaccine 01-17-2021. I have history of rare autoimmune disease, flared up. PT used hydrocortisone cream for my flare up and took zinc and her symptoms went away. When I get flare ups I also get also vasculitis and sores and lesions in my bodies. PT states she has no other symptoms. These episodes occurred exactly one week and half after my first and also on my second dose. I called my doctor and he told me to put some hydrocortisone and zinc medication. I think the Moderna vaccine probably triggered my auto immune system. The zinc medication stopped it from flaring up. It took three days for my flare ups to clear up. My second vaccine was at the Speedway at a parking lot. I do not have my lot# for my second dose, it was not written down.
64 2021-05-27 fainting Patient Fainted for few minutes and looked like she was seizing. Few minutes she was back up to norm... Read more
Patient Fainted for few minutes and looked like she was seizing. Few minutes she was back up to normal and stated that she fainted every time after a shot
64 2021-05-30 cerebrovascular accident, ischaemic stroke Acute onset stroke symptoms the afternoon of 4/13/21 after returning home from room. EMS transporte... Read more
Acute onset stroke symptoms the afternoon of 4/13/21 after returning home from room. EMS transported pt to local hospital. Dx with aortic arch/proximal subclavian artery thrombus, migration into axillary artery. Treated at local hospital with TNK for aortic arch clot & ischemic stroke. Transferred to tertiary medical center. Pt had massive stroke (left & right side) with brain stem herniation. Pt CMO after 16hrs and expired on 4/14, <32 hrs after symptom onset.
64 2021-05-30 chest pain Reported to MD via portal message that she doesn't think she should have any more COVID vaccines. S... Read more
Reported to MD via portal message that she doesn't think she should have any more COVID vaccines. She reports had 2nd injection on Wednesday afternoon and later that evening she started having hives and wheezing with chest pain and feeling like she couldn't breathe. She also reported having terrible nausea and this was followed by a fever and horrible body aches. Still having headache this morning.
64 2021-05-30 fibrin d dimer increased, pulmonary embolism 5/21 started feeling poorly, fatigue, shortness of breath, evening headaches 5/24 Fatigue, shortness... Read more
5/21 started feeling poorly, fatigue, shortness of breath, evening headaches 5/24 Fatigue, shortness of breath, unable to complete any task, low grade fever 99.8, unable to eat or drink well 5/25 severe heartburn, shortness of breath continued, extreme fatigue 5/28 went to ER with continued extreme shortness of breath and fatigue. CT scan revealed multiple clots in lungs and was admitted for needing oxygen and to start anticoagulation.
64 2021-05-30 hypertension, chest discomfort At 0920 I felt severe tingling in my lips and tongue. Was quickly triaged, it was getting harder to ... Read more
At 0920 I felt severe tingling in my lips and tongue. Was quickly triaged, it was getting harder to breathe, my BP was high, my SPO2 did not drop, my pulse was around 80. Tiny red hives started to appear on my forearms. I had taken 25 mg of benedryl, however an epic pen was recommended and given. I felt better immediately, although my chest still felt tight. I was not wheezing. I asked for and was given an albuterol inhaler which really helped, so I did to need admission to the hospital. I was there for about 2 hours. I was sent home with 2 epic pens in case I had a relapse.
64 2021-05-30 palpitations, chest pain Experienced dizziness, weakness, shortness of breath, nausea, headache, heart palpitations and inter... Read more
Experienced dizziness, weakness, shortness of breath, nausea, headache, heart palpitations and intermittent minor chest pain. Could not get an appointment with cardiologist till June 30th. Saw family doctor on May 24th. He stated that heart and lungs sounded good but ordered heart monitor appointment for June 3rd at hospital outpatient. Also have continuing pain under left arm
64 2021-05-30 pulmonary embolism, fibrin d dimer increased, blood clot Spinal fusion on January 12, 2021 one week after first vaccine. Second vaccine on Feb 2, 2021. Devel... Read more
Spinal fusion on January 12, 2021 one week after first vaccine. Second vaccine on Feb 2, 2021. Developed blood clot in right calf & pulmonary embolism in right lung the week of Feb 15th. May have been post op problem but I had no issue until after the 2nd vaccine. Surgeon felt that post op pts usually get a blood clot within 2 weeks after surgery- that's why I feel it was from the 2nd vaccine.
64 2021-06-01 chest pain, lightheadedness Face is red as a tomato; Face is swollen; Throat is closed and cannot breathe; Chest pain; Body ache... Read more
Face is red as a tomato; Face is swollen; Throat is closed and cannot breathe; Chest pain; Body aches; Her throat keeps closing up on her/ throat began to close up and off; Almost passing out; Almost passing out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (Her throat keeps closing up on her/ throat began to close up and off), NEAR DEATH EXPERIENCE (Almost passing out), ERYTHEMA (Face is red as a tomato), SWELLING FACE (Face is swollen), DYSPNOEA (Throat is closed and cannot breathe), CHEST PAIN (Chest pain), PRESYNCOPE (Almost passing out) and MYALGIA (Body aches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PRESYNCOPE (Almost passing out) (seriousness criterion hospitalization). On 17-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROAT TIGHTNESS (Her throat keeps closing up on her/ throat began to close up and off) (seriousness criteria hospitalization and life threatening) and NEAR DEATH EXPERIENCE (Almost passing out) (seriousness criteria hospitalization and medically significant). On 18-May-2021, the patient experienced ERYTHEMA (Face is red as a tomato) (seriousness criterion hospitalization), SWELLING FACE (Face is swollen) (seriousness criterion hospitalization), DYSPNOEA (Throat is closed and cannot breathe) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and MYALGIA (Body aches) (seriousness criterion hospitalization). The patient was hospitalized until 18-May-2021 due to CHEST PAIN, DYSPNOEA, ERYTHEMA, MYALGIA, NEAR DEATH EXPERIENCE, PRESYNCOPE, SWELLING FACE and THROAT TIGHTNESS. At the time of the report, THROAT TIGHTNESS (Her throat keeps closing up on her/ throat began to close up and off) had not resolved and NEAR DEATH EXPERIENCE (Almost passing out), ERYTHEMA (Face is red as a tomato), SWELLING FACE (Face is swollen), DYSPNOEA (Throat is closed and cannot breathe), CHEST PAIN (Chest pain), PRESYNCOPE (Almost passing out) and MYALGIA (Body aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Chest X-ray: (Inconclusive) Lungs look good. No concomitant medications were reported. Treatment included epinephrine (EpiPen), morphine, 2 breathing treatments (unknown) and diphenhydramine (Benadryl). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received on 18 May 2021. The product details updated. Event details updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
64 2021-06-01 hypertension, platelet count decreased I noticed lower extremity petechiae, and blood blisters in my mouth on 5/22/2021. Next day, on 5/23/... Read more
I noticed lower extremity petechiae, and blood blisters in my mouth on 5/22/2021. Next day, on 5/23/2021, the blood blister in my mouth was significantly larger, size of my thumb. Also blood blisters on my tongue. Petechiae was all over lower legs, and cropping up around bra line, scattered over torso. I went to urgent care where they drew my blood and told me my platelet count was zero. I have no previous history of any of this. They instructed me to go to the Emergency Department. At the hospital, more labs were drawn, and I was admitted to the oncology unit. I was given a transfusion of platelets. My blood pressure was extremely high, systolic 214. They started giving me IV hydralazine and metoprolol and I needed these IV blood pressure meds each day while there, although the metoprolol was only used a few times. They started me on lisinopril 5 mg around the 3rd day because IV meds didn't control my blood pressure for very long. They had to increase the dose to Lisinipril 10 mg on my 5th day in the hospital. I developed numerous large bruises all over my arms and some other areas, with more petechiae on my face. On the day after admission, I was given IVIG and more platelets, and started on a regimen of dexamethasone 40 mg IV times daily 4 days. The course of therapy was completed. I was discharged to home with a platelet count of 24 on 5/27/2021 with follow up with hematology and primary MD follow ups. Platelet count on 6/1/2021 was up to 185.
64 2021-06-02 pulmonary embolism Pt is 64 Had viral type pneumoia with out pos Covid test in January 2021. She was left oxygen dep... Read more
Pt is 64 Had viral type pneumoia with out pos Covid test in January 2021. She was left oxygen dependent at 2 liters of oxygen by NC. on the 14th of April she recieved her second Moderna Covid shot. Two days later she was begining to become very short of breath. Needed to turn up her oxygen. Paramedics came to her house and found that O2 sat on RA was 60. In my Emergency room her O2 sat was only 87 percent on her two liters and on 15 liters of oxygen she was only 94 Percent.
64 2021-06-03 fibrin d dimer increased, chest pain Chest pain, elevated systolic BP
64 2021-06-03 fast heart rate, fast heart rate Daily tachycardia (8-20 times per day), with duration of 1 min - over an hour, with pulse rate up t... Read more
Daily tachycardia (8-20 times per day), with duration of 1 min - over an hour, with pulse rate up to 130. Tachycardia lasted through March, April, and May. May 24th was the last episode.
64 2021-06-07 chest pain When I went to the bathroom it was all blood, my bowel movement; diarrhea; fatigue, it was horrible;... Read more
When I went to the bathroom it was all blood, my bowel movement; diarrhea; fatigue, it was horrible; horrible headache; real bad chest pains; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (When I went to the bathroom it was all blood, my bowel movement) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Diabetes. Concomitant products included SEMAGLUTIDE (OZEMPIC), INSULIN GLARGINE (TOUJEO) and INSULIN LISPRO (HUMALOG) for an unknown indication. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced CHEST PAIN (real bad chest pains), OROPHARYNGEAL PAIN (sore throat), FATIGUE (fatigue, it was horrible) and HEADACHE (horrible headache). On 25-May-2021, the patient experienced DIARRHOEA (diarrhea). On 26-May-2021, the patient experienced HAEMATOCHEZIA (When I went to the bathroom it was all blood, my bowel movement) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 24-May-2021, CHEST PAIN (real bad chest pains) had resolved. On 25-May-2021, OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, HAEMATOCHEZIA (When I went to the bathroom it was all blood, my bowel movement), DIARRHOEA (diarrhea), FATIGUE (fatigue, it was horrible) and HEADACHE (horrible headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient's concomitant drug included beta-blocker (unknown). Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
64 2021-06-09 blood pressure increased, inflammation of the pericardium, enlargement of the heart After my first vaccination I started to receive fever the night of. My fever would not go below 100.... Read more
After my first vaccination I started to receive fever the night of. My fever would not go below 100. Shortness of breath was also present. I also experienced pain in my left arm and left shoulder. Was informed I had pleural effusion and an enlarged heart. I also experienced chest pains along with jaw pain. My blood pressure was also elevated. I visited the ER and was given Nitroglycerin and my blood pressure stabilized. My physician tried giving me an EKG and I could not catch my breath. I also experienced inflammation in the lungs. I was placed on steroids and given a stress echo and an MRI. I was diagnosed with pericarditis and placed on steroids and an anti inflammatory.
64 2021-06-09 blood clot patient received the Moderna covid-19 vaccine and two days later states she was admitted to the ER w... Read more
patient received the Moderna covid-19 vaccine and two days later states she was admitted to the ER with blood clots. patient did not report the even to the pharmacy until the week of June 1st
64 2021-06-14 chest pain Pt reports feeling significant chest pain the night of his first vaccination. Pain has now been inte... Read more
Pt reports feeling significant chest pain the night of his first vaccination. Pain has now been intermittently bothersome and he has had multiple workups since that point.
64 2021-06-14 hypertension, chest pain high blood pressure averaging 170/100 constantly daily with chest pain, prior to vaccine average 130... Read more
high blood pressure averaging 170/100 constantly daily with chest pain, prior to vaccine average 130/76. Placed on Losartan 25 mg, 2t Qam and 1 t pm - not working
64 2021-06-15 heart rate increased, palpitations day 1-2: flu-like symptoms (including fever, nausea, sweating, malaise, loss of appetite) day 3: flu... Read more
day 1-2: flu-like symptoms (including fever, nausea, sweating, malaise, loss of appetite) day 3: flu like symptoms gone, now palpitations lasting several hours and elevated pulse. patient's pcp directed her to the emergency room
64 2021-06-17 excessive bleeding After first dose for two days I couldn't move my arm; Swollen with circular black and blue bruises i... Read more
After first dose for two days I couldn't move my arm; Swollen with circular black and blue bruises in the injection site; Trouble raising her arm; The huge sore became hot to touch; Blue bruises in the injection site; I think this happened because the person that administered the vaccine did it wrong; I don't think I received a full dose vaccine from first dose.; Arm bleed; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Arm bleed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Kidney stone (More than once) and Shingles (More than once). Concurrent medical conditions included Multiple allergies (had a lot of allergies) and Chronic pain. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 29-Apr-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HAEMORRHAGE (Arm bleed) (seriousness criterion medically significant), PRODUCT ADMINISTRATION ERROR (I think this happened because the person that administered the vaccine did it wrong), INCORRECT DOSE ADMINISTERED (I don't think I received a full dose vaccine from first dose.) and PAIN IN EXTREMITY (sore arm). On 01-May-2021, the patient experienced LIMB DISCOMFORT (Trouble raising her arm), VACCINATION SITE WARMTH (The huge sore became hot to touch), VACCINATION SITE BRUISING (Blue bruises in the injection site) and VACCINATION SITE SWELLING (Swollen with circular black and blue bruises in the injection site). On an unknown date, the patient experienced LIMB DISCOMFORT (After first dose for two days I couldn't move my arm). On 29-Apr-2021, PRODUCT ADMINISTRATION ERROR (I think this happened because the person that administered the vaccine did it wrong) and INCORRECT DOSE ADMINISTERED (I don't think I received a full dose vaccine from first dose.) had resolved. At the time of the report, HAEMORRHAGE (Arm bleed), VACCINATION SITE WARMTH (The huge sore became hot to touch), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE SWELLING (Swollen with circular black and blue bruises in the injection site) outcome was unknown and LIMB DISCOMFORT (Trouble raising her arm), VACCINATION SITE BRUISING (Blue bruises in the injection site) and LIMB DISCOMFORT (After first dose for two days I couldn't move my arm) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The patient wanted to report the side effects they experienced post receiving their first shot of Moderna vaccine. After a few hours their arm developed a huge sore 1 and ½ inches in size and the patient had trouble raising their arm. The patient day before reporting woke up and had a problem lifting their arm. The patient reported that the huge sore became hot to touch, was swollen with circular black and had blue bruises in the injection site. The patient mentioned that they had a lot of allergies. On 02-Jun-2021, the patient reported adverse reaction patient had from dose one and reported huge adverse reaction to dose two. The patient post first dose for two days was not able to move their arm and had a bruise that lasted for two weeks. The patient stated that now they think this happened because the person that administered the vaccine did it wrong and vaccine went into wrong place. Post receiving their first dose the patient said one of their arms was bleeding. The patient went back to the vaccination site and had been complaining so much because the registered nurse let the patient know that the Nurse didn't wore gloves nor shield and was anti-vaccinated. The patient also stated that they don't think that they received a full dose vaccine from first dose. The patient also reported that they were a chronic pain patient and had kidney stone and shingles more than once and understood pain. The patient wanted antibody test done because the patient think they didn't receive a full active first dose and wanted to have it after first dose but couldn't get it and still wanted to do this post second dose. Concomitant medication reported also included over the counter medicine but didn't specified the name. No treatment medication was reported. The patient informed that they slept and drunk a lot. No specific treatment was taken. Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site swelling are consistent with the known safety profile of the vaccine. This case was linked to MOD-2021-201885 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Email response. No significant information found. On 02-Jun-2021: Added Reporter Details. Added current and historical conditions under relevant medical history. Updated action taken. Updated concomitant medication in I-narrative supplement field. Added new events and updated the event description and outcome of the events.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site swelling are consistent with the known safety profile of the vaccine.
64 2021-06-20 palpitations Pt completed a 66min observation with the following symptoms: palpitations, dizziness, flushing, itc... Read more
Pt completed a 66min observation with the following symptoms: palpitations, dizziness, flushing, itching, SOB, nausea, headache. No medications was given.
64 2021-06-20 fast heart rate Started at 1 am with chills, followed by 38.3 temperature. At 3 AM, fever sank to 37.4 and tachycard... Read more
Started at 1 am with chills, followed by 38.3 temperature. At 3 AM, fever sank to 37.4 and tachycardia with up to 125 bpm began. Blood pressure 160/74. Rash covered face and neck. Treated with Aconitum D30 (homeopathic medicine), lowered pulse rate to the 90's. Still suffered orthostatic peaks of 125. With stable higher blood pressures of 145/80, at 6 AM took 1,25 mg bisoprolol. This took the pulse down to the 80's. Orthostatic elevated pulse continued throughout the day and into the evening. In the evening, normal blood pressure, pulse and temperature. Rash was gone.
64 2021-06-22 blood glucose increased About six weeks after the second Moderna COVID vaccine, I started experiencing thirst, more frequent... Read more
About six weeks after the second Moderna COVID vaccine, I started experiencing thirst, more frequent urination and noted some weight loss. This continued and then by end of April 2021, I started experiencing other symptoms including white flakes in urine, cramps in calves, and dry mouth. I sought medical care for these odd symptoms and despite having normal blood glucose at annual physicals, including in July 2020, my blood glucose run on 6/10/21 was 379. I do not have any history of diabetes nor is it in my family history, parents, siblings, grandparents and aunts/uncles on both sides. I have been started on glucose monitoring and insulin as of 6/18 with my primary care physician. I have a follow up with an endocri
64 2021-06-22 chest pain Four days after my second shot (above info) I ended up with temps over 104 , coughing, sweating and ... Read more
Four days after my second shot (above info) I ended up with temps over 104 , coughing, sweating and hurt really bad all over. About 2 weeks alter after looking back, I had some shortness of breath and chest pains. I didn't think anything of it. and blew it off. Then about 3'ish weeks ago the chest pains came back, and again I blew it off. (it was a burning feeling, like I had been out in freezing weather without a scarf over my mouth). I have also been getting dizzy often in the past month. Started walking up an incline to town and it got worse, this time I was short of breath as well. It was the same in the cabin after going up one flight of stairs. This happened 2 more times. So we came home and I went to our local hospital. Nothing showed on the tests, EKG, Stress, and Echo. I do have a Biotel monitor on for 30 days. Even though nothing showed on the tests, I'm still having issues. The Cardio doctor thought it might be A-Fib. Appointment on July 19th at 2:15 for a follow up.
64 2021-06-23 blood pressure increased Pt presented for 1st dose Moderna Vaccine. Reviewed and completed required documentation prior to ... Read more
Pt presented for 1st dose Moderna Vaccine. Reviewed and completed required documentation prior to administration. Around 5 min. post immunization pt exhibited N/V, supervisor informed. pt vitals were taken, informed provider CRNP. instructed oral nausea medication. pt refused EMT at that time. Pt given Zofran 4mg PO. Pt was unable to keep down. Vitals were taken every 10 min. with elevated bp. Informed Dr. of situation and urged pt to go to ER. Pt agreed, EMT was contacted and arrived around 20 min. after. Prior to EMT arrival pt C/O left jaw tightness. EMT arrived and transported pt to Hospital
64 2021-06-23 chest discomfort, palpitations, chest pain Some background info: I had shingles the month of April. Went on Famciclovir anti-viral medicine imm... Read more
Some background info: I had shingles the month of April. Went on Famciclovir anti-viral medicine immediately and had to reschedule my COVID-19 vaccine. It was originally schedule for April 1st. Did not wait 90 days, only about 2 weeks before getting the Moderna shot on April 15th 10:30. The nurse practitioner said it should be fine to get the shot then. 2nd shot was May 13th. 1:00. First shot COVID-19 reaction was delayed, was a large red (about 2.5?), inflamed and sore area at the shot site. Lasted about 4-5 days. The second shot reaction occurred about 12 hours after the shot and was intense. The worst was uncontrollable shaking with my heart feeling like it was bursting out of my chest with irregular, fast pounding palpitations and intense shingles like pain everywhere. Especially in my lymph nodes and chest. My hands were so stiff and swollen I couldn't move them! Bones were grinding with shooting pain everytime I tried to reposition to try and get in a position that didn't hurt. Impossible...I thought I might be having a heart attack it woke me from a sound sleep at 1:30 in the morning. When the shakes subsided in about an hour, I decided not to call 911, figured I was going to live! It was really scary. Worst pain I've ever been in, would rather wear a mask all the rest of my days then get another moderna shot! Now I am having lots of arthritis like pain in my hands, neck and shoulders, even my toes. I?m having trigger finger everyday in one or the other of my hands and had a one time strange cramping and paralysis in both my hands at the same time that started at the base of my thumb and flowed up my index finger making my hands look deformed. It lasted a few minutes then subsided. Also headaches are constant and more painful than before shot. I am still having some random heart palpitations and tightness, and pain in my chest. I tire more easily, especially after lifting and exercise. Waking up at night more between 1-3 am. Much more body aches and pains in general, but especially in my hands, head, chest, neck, shoulders and lymph nodes.
64 2021-06-23 chest pain, chest discomfort, ischemic chest pain, palpitations lots of chest pain ( angina) , pressure, burning, palpatations
64 2021-06-25 inflammation of the pericardium Pericarditis
64 2021-06-26 pulmonary embolism Dual Pulmonary Embolism, Dr. Office ordered labs, called to go to ER stat. ER did Ultrasound of he... Read more
Dual Pulmonary Embolism, Dr. Office ordered labs, called to go to ER stat. ER did Ultrasound of heart- the Cat scan of lungs. Sent by ambulance to HCF that day - taken to Cath lab that same evening for a clot busting procedure and administered tPA and heparin.
64 2021-06-28 blood pressure decreased After receiving the vaccine, on 4/14, I had a hysterectomy and came home. I began feeling a dull pai... Read more
After receiving the vaccine, on 4/14, I had a hysterectomy and came home. I began feeling a dull pain in my back. It started getting worse. I contacted my doctor who sent me to the emergency. They took my blood and from there i began falling to pieces. I couldn't breathe, My upper back around my lungs was hurting so bad. They gave me many different pain medications but nothing was helping the pain. They determined I had 2 blood clots in my right lung. I started going downhill from there. They told me my blood was contaminated. I was put on many different machines. All COVID tests came back negative. Nothing hurt from the hysterectomy. My blood pressure wouldn't stay up. I was on pain medications every 2 hours. Currently, it has still not been determined whether this was a result of the vaccine or not. I am now taking Eliquis which I will be taking for 6 months.
64 2021-06-28 chest discomfort, heart attack next day chest pressure, lasted days off & on, neck shoulders hurt, stents from heart attack
64 2021-06-29 blood pressure increased Trouble walking; inability to lift right leg; experienced a headache describing that " an explosion ... Read more
Trouble walking; inability to lift right leg; experienced a headache describing that " an explosion happened in my head; High BP 172/95-98; left arm felt heavy with numbness all the way to fingertips; lethargy; vertigo; Lightheadedness; dehydration; Tingling all the way to fingertips; general fatigue; diarrhea; belching; blurred vision; Mouth dry; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (Lightheadedness), DEHYDRATION (dehydration), PARAESTHESIA (Tingling all the way to fingertips), FATIGUE (general fatigue), GAIT DISTURBANCE (Trouble walking), HYPOKINESIA (inability to lift right leg), BLOOD PRESSURE INCREASED (High BP 172/95-98), HYPOAESTHESIA (left arm felt heavy with numbness all the way to fingertips), LETHARGY (lethargy) and HEADACHE (experienced a headache describing that " an explosion happened in my head) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anaphylaxis, Coronary artery disease, Asthma, Gastroesophageal reflux disease, Osteoarthritis, Hypoglycemia, Hypothyroidism, Hypertension, Allergy to antibiotic (The patient is allergic to Levaquin.), Drug allergy (The patient is allergic to Vioxx.), Shellfish allergy and Arrhythmia. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), ASPIRIN [ACETYLSALICYLIC ACID], ATENOLOL (TENORMIN), UBIDECARENONE (COQ10 [UBIDECARENONE]), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), GABAPENTIN (NEURONTIN), VITAMIN B12 [VITAMIN B12 NOS], CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), LEVOSALBUTAMOL TARTRATE (XOPENEX HFA), EPINEPHRINE (EPIPEN), NITROGLYCERIN, ALBUTEROL [SALBUTAMOL], BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), MONTELUKAST SODIUM (SINGULAIR), LEVOTHYROXINE SODIUM (SYNTHYROID), ROSUVASTATIN CALCIUM (CRESTOR) and DONEPEZIL HYDROCHLORIDE (ARICEPT) for an unknown indication. On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced VERTIGO (vertigo) (seriousness criterion hospitalization), DIZZINESS (Lightheadedness) (seriousness criterion hospitalization), DEHYDRATION (dehydration) (seriousness criterion hospitalization), PARAESTHESIA (Tingling all the way to fingertips) (seriousness criterion hospitalization), FATIGUE (general fatigue) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (High BP 172/95-98) (seriousness criterion hospitalization), HYPOAESTHESIA (left arm felt heavy with numbness all the way to fingertips) (seriousness criterion hospitalization), LETHARGY (lethargy) (seriousness criterion hospitalization), DRY MOUTH (Mouth dry) and NAUSEA (nausea). On 19-Jun-2021, the patient experienced HYPOKINESIA (inability to lift right leg) (seriousness criterion hospitalization) and HEADACHE (experienced a headache describing that " an explosion happened in my head) (seriousness criterion hospitalization). On 20-Jun-2021, the patient experienced VISION BLURRED (blurred vision). On 21-Jun-2021, the patient experienced DIARRHOEA (diarrhea) and ERUCTATION (belching). On an unknown date, the patient experienced GAIT DISTURBANCE (Trouble walking) (seriousness criterion hospitalization). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) ongoing from 21-May-2021 at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo), DIZZINESS (Lightheadedness), DEHYDRATION (dehydration), PARAESTHESIA (Tingling all the way to fingertips), FATIGUE (general fatigue), GAIT DISTURBANCE (Trouble walking), HYPOKINESIA (inability to lift right leg), BLOOD PRESSURE INCREASED (High BP 172/95-98), HYPOAESTHESIA (left arm felt heavy with numbness all the way to fingertips), LETHARGY (lethargy), HEADACHE (experienced a headache describing that " an explosion happened in my head), VISION BLURRED (blurred vision), DIARRHOEA (diarrhea), DRY MOUTH (Mouth dry), ERUCTATION (belching) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. After the patient received the first dose of the Moderna COVID-19 vaccine on 21 May 2021, the patient reports having a black and blue arm as a side effect from receiving that dose. The patient experienced high BP 172/95-98, which resolved to systolic BP of 155 by the time of discharge from the vaccine facility. The patient's left arm felt heavy with numbness and tingling down the entire arm to the finger tips. At the vaccine facility, the patient was treated with Benadryl and rest until they felt good enough to go home. After arriving home the patient experienced generalized fatigue, continued numbness and tingling of left arm, lightheadedness, increased blood pressure, and lethargy and presented to their local ER where they were treated for dehydration and given meclizine. The decision was made to keep the patient overnight where they were observed and discharged 19 Jun 2021. During their observation period, the patient experienced a headache describing that " an explosion happened in my head" as well as the inability to lift their right leg and trouble walking, which required the use of a wheelchair. There was no report of any additional treatment given for these symptoms. The patient is currently experiencing the above mentioned symptoms intermittently with the addition of: belching, the inability to lift the right leg, and blurred vision (onset 20 Jun 2021) and diarrhea ( onset 21 Jun 2021). The patient has Coronary Artery Disease for which they have three cardiac stents. The patient is Rh NEG. The patient is epileptic and has a cervical spine fusion. The patient is also allergic to steroids. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the eventS, a causal relationship cannot be excluded.
64 2021-06-29 deep vein blood clot, blood pressure decreased My first Moderna dose was 2/26. I had a low-grade temp and body aches on the 9th day for 24 hours. T... Read more
My first Moderna dose was 2/26. I had a low-grade temp and body aches on the 9th day for 24 hours. The second dose was on 3/26. That afternoon my eyes were burning with eye strain. On Saturday into Sunday had low grade temp escalating to 101.5 p.o. with severe body aches, fatigue, and loose stools. My blood pressure dropped to BPS of 80's on Monday morning. On Thursday following had leg discomfort ? sciatica and episode of SOB. On Friday, another episode of SOB. On Sunday (April 4th), noted left ankle/leg swelling which persisted on and off for next two months. Swelling went down with leg elevation. Early June, had developed severe sciatica on left. Appointment with primary provider June 18th. Left leg remained swollen and sciatica was severe enough to cause difficulty with ambulation. Doppler studies completed 6/21/2021. Results below in #19.
64 2021-06-29 fast heart rate I had been on weekly diflucan for toe fungus starting in late March. I got the first Moderna shot A... Read more
I had been on weekly diflucan for toe fungus starting in late March. I got the first Moderna shot April 13. On April 22 I had some chest tightness which I attributed to the Diflucan as it listed chest tightness as a side effect. On May 2nd the pain extended from the chest, neck, headache and all my teeth hurt and I ended up in the hospital for the first of 3 hospitalizations Below is the summary of doctor?s notes on my hospitalizations. They ran several tests to eliminate lupus, sjogrens, cancer, kidney issues, bacterial or fungus issues, etc. It was not caused by the Diflucan side effect. They decided it might be viral. Given the current report of some people getting pericarditis after the vaccine, my doctor and I felt we should report this incident. Given the timing, it could have been the vaccine that caused the reaction. I'm currently on prednisone for another month and colchicine for several more months and remain under the care of cardiology. SUMMARY OF DOCTOR?S NOTES: She presented to the ER 5/2/2021 with chest pain. When she presented, she had tachycardia with interior ST changes. CT showed no PE but there was a large pericardial effusion. Subsequently her blood pressure began dropping with narrowing pulse pressure and she was thought to have early tamponade physiology so was taken to the cath lab and pericardiocentesis was performed. She did well and was started on colchicine and ibuprofen. 5/14 When I saw her back, she was doing well. Since then, she has had back to back admissions: 5/24/2021-5/27/2021-CAP of LLL with bilateral pleural effusions and pericarditis treated with antibiotics but afterwards, felt to be viral. She was seen by Pulmonary at this hospital stay. Rheumatologist work up was started. ECHO was stable. 5/29 Second Moderna shot (was delayed 2 weeks due to concern about confusing the potential normal side effects with the pericarditis issues). 6/13/2021-6/15/2021-Serositis with tachycardia, cough and fever. Rheumatology did not see but was curb sided and recommended Prednisone (long taper) with clinic visit in the next 2 weeks. Limited ECHO was stable. 6/16 Patient is doing well. No chest pain. She is taking the Prednisone without issues. No GI upset and no loose stools.
64 2021-07-02 fainting Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: patient started calling for help about 5 mins after receiving the vaccine. stated she felt dizzy while sitting. I asked if she could stand up for me to get her on the ground but she could not. her eyes started to roll, i took off her mask to help her get a deep breathe. she was still somewhat responsive but started to fade in & out. paramedics were called using my phone. She did not fully pass out but had slurred speech, complained of dizziness, chills,& was confused
64 2021-07-02 blood clot discomfort in her back like she slept wrong; could not take a deep breath without pain; she felt lik... Read more
discomfort in her back like she slept wrong; could not take a deep breath without pain; she felt like something was off/felt vaguely like she did in 2012 (when she had a pulmonary embolism); 3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times; pain if take a deep breath and sneeze; lethargy; slight tenderness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times) and PAIN (pain if take a deep breath and sneeze) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pulmonary embolism in 2012, Legionnaire's disease in 2012 and Sprained ankle in 2012. Previously administered products included for Pulmonary embolism: Warfarin (She was placed on warfarin at that time along with an injection in her abdomen that she did not recall the name of the shot.) in 2012. Concurrent medical conditions included COPD. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced THROMBOSIS (3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times) (seriousness criteria medically significant and life threatening), PAIN (pain if take a deep breath and sneeze) (seriousness criterion medically significant), MUSCULOSKELETAL DISCOMFORT (discomfort in her back like she slept wrong), DYSPNOEA (could not take a deep breath without pain) and FEELING ABNORMAL (she felt like something was off/felt vaguely like she did in 2012 (when she had a pulmonary embolism)). In 2021, the patient experienced LETHARGY (lethargy) and VACCINATION SITE PAIN (slight tenderness in her arm). The patient was treated with APIXABAN ongoing from 14-Jun-2021 for Clot blood, at a dose of 10 mg twice a day and APIXABAN ongoing from 22-Jun-2021 for Clot blood, at a dose of 5 mg twice a day. In June 2021, PAIN (pain if take a deep breath and sneeze), MUSCULOSKELETAL DISCOMFORT (discomfort in her back like she slept wrong), DYSPNOEA (could not take a deep breath without pain) and FEELING ABNORMAL (she felt like something was off/felt vaguely like she did in 2012 (when she had a pulmonary embolism)) had resolved, LETHARGY (lethargy) and VACCINATION SITE PAIN (slight tenderness in her arm) had resolved. At the time of the report, THROMBOSIS (3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, Blood test: high clotting factor (abnormal) The clotting factors in the blood test were four times over a certain number of normal.. On 14-Jun-2021, Scan: blood clots (abnormal) Two blood clots in her left lung and one blood clot in her right lung. The concomitant medications on use were not provided. On 13-Mar-2021, received second dose of Moderna COVID-19 Vaccine. On 14-Jun-2021, the patient experienced THROMBOSIS (3 blood clots in her lungs/clotting factors in the blood test were four times over a certain number of normal/she had two blood clots in her left lung and one blood clot in her right lung/clotting factors in the blood test were four times. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
64 2021-07-04 loss of consciousness After a rough night of fever, chills and muscle pain I awoke in the morning and poured some orange j... Read more
After a rough night of fever, chills and muscle pain I awoke in the morning and poured some orange juice. Suddenly I passed out and fell on the kitchen floor, injuring my right ankle.
64 2021-07-05 deep vein blood clot deep venous thrombosis in left leg and calf
64 2021-07-06 atrial fibrillation, cardiac failure congestive, inflammation of the pericardium, chest pain, fluid around the heart 5/11/21 developed chest pain, had initial improvement, then worsening on approx 5/26/21. on 6/4, she... Read more
5/11/21 developed chest pain, had initial improvement, then worsening on approx 5/26/21. on 6/4, she was diagnosed with pericarditis and acute CHF, afib with RVR. Pericarditis has been treated with indomethacin, colchicine, and she is improving with CRP normalized. Afib treated successfully with cardioversion. she was treated with diuretics for her CHF.
64 2021-07-06 low blood oxigenation 6/18/21: Guest experienced episode of hypoxia. Was able to be corrected with use of )2. Chest X-ray ... Read more
6/18/21: Guest experienced episode of hypoxia. Was able to be corrected with use of )2. Chest X-ray and bloodwork completed. 6/28/21: Seen by NP for weight loss. Ongoing issue prior to vaccine r/t poor appetite 7/1/21: Incident of hypoxia that required increase in 02, SOB, and lethargy. Sent to the hospital. Guest did end up passing at this hospital
64 2021-07-06 heart attack Patient was airlifted to the hospital where she was diagnosed with a heart attack; Difficulty breath... Read more
Patient was airlifted to the hospital where she was diagnosed with a heart attack; Difficulty breathing; Numbness; Discomfort; Nausea; Vomiting; Burning/arm felt sore; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Patient was airlifted to the hospital where she was diagnosed with a heart attack), DYSPNOEA (Difficulty breathing), HYPOAESTHESIA (Numbness), DISCOMFORT (Discomfort), NAUSEA (Nausea) and VOMITING (Vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01003807772739901769) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Patient was airlifted to the hospital where she was diagnosed with a heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness) (seriousness criterion medically significant), DISCOMFORT (Discomfort) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Burning/arm felt sore). At the time of the report, MYOCARDIAL INFARCTION (Patient was airlifted to the hospital where she was diagnosed with a heart attack), DYSPNOEA (Difficulty breathing), HYPOAESTHESIA (Numbness), DISCOMFORT (Discomfort), NAUSEA (Nausea), VOMITING (Vomiting) and PAIN IN EXTREMITY (Burning/arm felt sore) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. The patient was discharged several days later. Very limited information regarding this event/s has been provided at this time. Further information has been requested. This case was linked to MOD-2021-237455 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Non-significant follow-up added to include Lot number; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
64 2021-07-07 chest discomfort Central chest pressure & tightness, that moved across left shoulder. Clammy and cold sweat, feeling ... Read more
Central chest pressure & tightness, that moved across left shoulder. Clammy and cold sweat, feeling of dread. Lasted possibly 5 minutes. Other than these symptoms, only local muscle soreness at injection site.
64 2021-07-08 palpitations Heart palpitations, was given a home monitor, mild heart issue, stomach pain and acid reflux, hard t... Read more
Heart palpitations, was given a home monitor, mild heart issue, stomach pain and acid reflux, hard to swallow.
64 2021-07-11 blood pressure increased Reported tingling lips after dose #2 as well as a "thick tongue" and mucous. Patient reported use o... Read more
Reported tingling lips after dose #2 as well as a "thick tongue" and mucous. Patient reported use of epi-pen and tingling lips with vaccine #1. Provider contacted. BP 179/103, HR 73. Instructed to give Benadryl 25 mg PO and repeat the dose when got home. Lips and tongue felt better after benadryl. Received Epi after 1st shot of Covid Vaccine. This was #2. Note states had an epi-pen for dose #1 and tingling lips. Do not see documented with past immunization. Upon release: Elevated BP - instructed patient to contact PCP.
64 2021-07-11 heart rate increased, oxygen saturation decreased At first within three days I became extremely fatigued. I had to take a nap during the day and I wou... Read more
At first within three days I became extremely fatigued. I had to take a nap during the day and I would sleep between 2-3 hours. I work in home health and I was able to go to work. I work part time but it was extremely hard for me to work with all the fatigue. That lasted for three weeks and then I developed like cold symptoms. Congestion, cough, light sensitivity and fever on off and the fatigue. I had a cough and it just never went away after the cold symptoms went away that has persisted until this day. I'm oxygen therapy. So I had a chest CT the first one was 05/28/2021 and they found ground glass opacities. They found atlectifis. Basically my lungs are scarred like someone who had covid but all my covid test have been negative. I had to go to the hospital about three weeks ago for extreme shortness of breath. When I'm up walking around without oxygen I was dropping to 84% and my heartrate would go up to 128. So they sent me home and I'm oxygen when I'm up walking around and when I'm sleeping now. They've also tested me for different things like parasite and bacteria. The only thing that they found was efinophilic pneumonia. I am on 60mg of prednisone daily. My lungs are improving a little bit but I still need oxygen. I'm being followed my a pomologist right now.
64 2021-07-11 fluid around the heart, chest discomfort, chest pain, inflammation of the pericardium chest tightness, occasional pain in the chest area, discomfort and pain when changing position fro... Read more
chest tightness, occasional pain in the chest area, discomfort and pain when changing position from vertical to horizontal. symptoms persisted. hospitalized with a diagnosis of pericarditis, pericardial effusion and pleural effusion.
64 2021-07-12 inflammation of the pericardium, chest pain Pericarditis and pleural effusions bilaterally in May 2021 may or may not have anything with it.... Read more
Pericarditis and pleural effusions bilaterally in May 2021 may or may not have anything with it. I am a female and 65 . 6 negative covid PCR since may fever low grade 100.9 to 102.9 ,pain in shoulders and chest ,shortness of breath, pleural effusions and pericarditis. the pericarditis may have started earlier and that is unclear
64 2021-07-12 blood clot Blood clot, uterine bleeding for 5 days.
64 2021-07-13 blood pressure increased I was ill with side effects about 4-6 hrs following the second dose with headache, fever 101.8 and f... Read more
I was ill with side effects about 4-6 hrs following the second dose with headache, fever 101.8 and fatigue. I felt fine the next day and at 7 am I went to give blood for my health insurance and I was told my BP was high 190+/85+ and repeat in second arm was similar. I was told to come back in a few weeks since my BP was high. I've never had high BP. I felt like my internal organs were inflammed and had random pain in the abdomen including a mild pain which felt like a costochondritis. I bought a BP monitor and it remained elevated for about 3 weeks, slowly went down and has been normal since. All the pains subsided around the same time. i continue t omonitor my BP and it has been normal (114/62 last check). Nore : I am a career public health RN and am reporting because I understand the importance of vaccine monitoring especially for new vaccines. I have to say I am very healthy and this was unexpected for me. I did not visit the DR because I thought it may be from taking the ES Tylenol every 4-6 hr for the day for the side effects, something which I rarely do. Please contact me if you need additional info. I wish now I would have had the bloodwork done that day as it may have shown some irregularities supporting my symptoms. Unfortunately I have no testing or documentation. My subsequent annual bloodwork was normal (CHEM 20, CBC, AIC)
64 2021-07-13 inflammation of the pericardium PERICARDITITIS THAT RESULTED IN ER VISIT AND CONSULTATION WITH CARDIOLOGIST. DID NOT RESULT IN HOSPI... Read more
PERICARDITITIS THAT RESULTED IN ER VISIT AND CONSULTATION WITH CARDIOLOGIST. DID NOT RESULT IN HOSPITALIZATION.
64 2021-07-17 loss of consciousness, blood pressure increased nerve damage; entire body became inflamed - Huge inflammation; can't move arm/can't hold on to anyth... Read more
nerve damage; entire body became inflamed - Huge inflammation; can't move arm/can't hold on to anything/can't move left leg/can hardly move; Shaking; Bad reaction; coagulation problem; Tremors in the head (brain); Blood pressure went to roof - high blood pressure "169"; cannot walk down; unable to work for a month and half; wrists are swollen - right knee is swollen; Feeling awful; In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts; whole-body hurts; Passing out; kidneys are shutting down; Von Willebrand disease (spelled it out on phone as"gon wille brand'l"; paralyzed; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out), RENAL IMPAIRMENT (kidneys are shutting down), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l") and PARALYSIS (paralyzed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passing out) (seriousness criteria disability and medically significant), RENAL IMPAIRMENT (kidneys are shutting down) (seriousness criteria disability and medically significant), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l") (seriousness criteria disability and medically significant), PARALYSIS (paralyzed) (seriousness criteria disability and medically significant), NERVE INJURY (nerve damage), INFLAMMATION (entire body became inflamed - Huge inflammation), MOBILITY DECREASED (can't move arm/can't hold on to anything/can't move left leg/can hardly move), TREMOR (Shaking), VACCINATION COMPLICATION (Bad reaction), COAGULOPATHY (coagulation problem), HEAD TITUBATION (Tremors in the head (brain)), BLOOD PRESSURE INCREASED (Blood pressure went to roof - high blood pressure "169"), GAIT INABILITY (cannot walk down), IMPAIRED WORK ABILITY (unable to work for a month and half), JOINT SWELLING (wrists are swollen - right knee is swollen), FEELING ABNORMAL (Feeling awful), PAIN (In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts) and MYALGIA (whole-body hurts). At the time of the report, LOSS OF CONSCIOUSNESS (Passing out), RENAL IMPAIRMENT (kidneys are shutting down), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l"), PARALYSIS (paralyzed), NERVE INJURY (nerve damage), INFLAMMATION (entire body became inflamed - Huge inflammation), MOBILITY DECREASED (can't move arm/can't hold on to anything/can't move left leg/can hardly move), TREMOR (Shaking), VACCINATION COMPLICATION (Bad reaction), COAGULOPATHY (coagulation problem), HEAD TITUBATION (Tremors in the head (brain)), BLOOD PRESSURE INCREASED (Blood pressure went to roof - high blood pressure "169"), GAIT INABILITY (cannot walk down), IMPAIRED WORK ABILITY (unable to work for a month and half), JOINT SWELLING (wrists are swollen - right knee is swollen), FEELING ABNORMAL (Feeling awful), PAIN (In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts) and MYALGIA (whole-body hurts) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatinine: 0.50 (Inconclusive) Patient stated her creatinine was 0.50. On an unknown date, Blood pressure measurement: 169 (High) high blood pressure 169. On an unknown date, C-reactive protein: 34/7 (Inconclusive) huge inflammation with c-reactive protein. C-reactive protein at 34.7. On an unknown date, Computerised tomogram: inconclusive (Inconclusive) chest suggested no blood clots per patient. On an unknown date, Fibrin D dimer: 3.89 (Inconclusive) Patient reported that D-dimer (which was usually found after blood clot was present and was in process of breaking down). On an unknown date, Haematocrit: 32.9 (normal) normal. On an unknown date, Haemoglobin: 10.8 (Inconclusive) It was 14 before 3 week ago and was normal and 14 (Inconclusive) It was 14 before 3 week ago. On an unknown date, Monocyte count: 0.91 (High) monocytes are high. On an unknown date, Pain assessment (1-10): 10 (abnormal) hurts at 10 on pain scale from 1-10. On an unknown date, Red blood cell sedimentation rate: 69 (Inconclusive) Sedimentation rate was 69. On an unknown date, Sepsis: negative (Negative) tested negative. On an unknown date, X-ray: inconclusive (Inconclusive) right knee is swollen per x-ray. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered LOSS OF CONSCIOUSNESS (Passing out), RENAL IMPAIRMENT (kidneys are shutting down), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l"), PARALYSIS (paralyzed), NERVE INJURY (nerve damage), INFLAMMATION (entire body became inflamed - Huge inflammation), MOBILITY DECREASED (can't move arm/can't hold on to anything/can't move left leg/can hardly move), TREMOR (Shaking), VACCINATION COMPLICATION (Bad reaction), COAGULOPATHY (coagulation problem), HEAD TITUBATION (Tremors in the head (brain)), BLOOD PRESSURE INCREASED (Blood pressure went to roof - high blood pressure "169"), GAIT INABILITY (cannot walk down), IMPAIRED WORK ABILITY (unable to work for a month and half), JOINT SWELLING (wrists are swollen - right knee is swollen), FEELING ABNORMAL (Feeling awful), PAIN (In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts) and MYALGIA (whole-body hurts) to be related. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient stated that she had gone to hospital on 14th and 16th of June 2021 and on 06 Jul 2021. The patient stated that her doctor told her that if she was not treated within a week or 2, she will be gone. The patient stated that due to coagulation problem, she should not have gotten the vaccine per patient and said it was her doctor's fault. The patient stated that she will have to go to ER if anything happens and stated that Moderna vaccine gave her all symptoms and the patient stated that she did not get Covid and was now scared that she will die. Company Comment: Very limited information regarding the events has been provided at this time. Additional information required. Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received on 9 Jul 2021 contain new serious and non serious events , suspect product dose details, lab data and narrative updated.; Sender's Comments: Very limited information regarding the events has been provided at this time. Additional information required.
64 2021-07-22 anaemia Dizziness, light headed, fatigue
64 2021-07-23 cerebrovascular accident The doctors at the hospital diagnosed as a stroke/She was discharged the next day; This spontaneous ... Read more
The doctors at the hospital diagnosed as a stroke/She was discharged the next day; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (The doctors at the hospital diagnosed as a stroke/She was discharged the next day) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03B21A and 037A21B) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included APIXABAN (ELIQUIS), QUINAPRIL and ATORVASTATIN for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (The doctors at the hospital diagnosed as a stroke/She was discharged the next day) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 13-May-2021 to 14-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (The doctors at the hospital diagnosed as a stroke/She was discharged the next day) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information were not provided. On 13May2021, she had started with numbness on fingertip of right side of the hand and it progressed to the whole right side. She called 911 and she ended up in hospital on 13May2021. The doctors at the hospital diagnosed as a stroke. She was discharged the next day (14May2021). Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
64 2021-07-27 blood pressure increased belching; diarrhoea; blurred vision; experienced a headache describing that " an explosion happened ... Read more
belching; diarrhoea; blurred vision; experienced a headache describing that " an explosion happened in my head; lightheadedness; drying of the mouth and throat; vertigo; nausea; Dehydration; Tingling all the way to fingertips; general fatigue; trouble walking; inability to lift right leg; hypoaesthesia; lethargy; lethargy; dizziness; anaphylactic reaction; vaccination site bruising; blood pressure increase; paraesthesia left arm; dehydration; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), DIZZINESS (dizziness), DRY MOUTH (drying of the mouth and throat), VERTIGO (vertigo), ERUCTATION (belching), DEHYDRATION (Dehydration), PARAESTHESIA (Tingling all the way to fingertips), FATIGUE (general fatigue), GAIT DISTURBANCE (trouble walking), MOVEMENT DISORDER (inability to lift right leg), HYPOAESTHESIA (hypoaesthesia), the second episode of LETHARGY (lethargy), HEADACHE (experienced a headache describing that " an explosion happened in my head), VISION BLURRED (blurred vision), DIARRHOEA (diarrhoea), NAUSEA (nausea), the first episode of LETHARGY (lethargy) and ANAPHYLACTIC REACTION (anaphylactic reaction) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Fusion cervical spine. Concurrent medical conditions included Anaphylaxis, Coronary artery disease, Asthma, Gastroesophageal reflux disease, Osteoarthritis, Hypoglycemia, Hypothyroidism, Hypertension, Allergy to antibiotic (levaquin), Drug allergy (vioxx), Shellfish allergy, Arrhythmia, Epilepsy and Allergy (steroids). Concomitant products included EPINEPHRINE (EPIPEN), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), ASPIRIN [ACETYLSALICYLIC ACID], ATENOLOL (TENORMIN), UBIDECARENONE (COQ10 [UBIDECARENONE]), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), GABAPENTIN (NEURONTIN), VITAMIN B12 [VITAMIN B12 NOS], CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), NITROGLYCERIN, ALBUTEROL [SALBUTAMOL], BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), MONTELUKAST SODIUM (SINGULAIR), LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR) and DONEPEZIL HYDROCHLORIDE (ARICEPT) for an unknown indication, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR). On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced DIZZINESS (dizziness) (seriousness criterion hospitalization prolonged), the first episode of LETHARGY (lethargy) (seriousness criterion hospitalization), VACCINATION SITE BRUISING (vaccination site bruising), BLOOD PRESSURE INCREASED (blood pressure increase), PARAESTHESIA (paraesthesia left arm), DEHYDRATION (dehydration) and FATIGUE (fatigue). On 18-Jun-2021, the patient experienced DIZZINESS (lightheadedness) (seriousness criterion hospitalization prolonged), DRY MOUTH (drying of the mouth and throat) (seriousness criterion hospitalization prolonged), VERTIGO (vertigo) (seriousness criterion hospitalization prolonged), DEHYDRATION (Dehydration) (seriousness criterion hospitalization prolonged), PARAESTHESIA (Tingling all the way to fingertips) (seriousness criterion hospitalization prolonged), FATIGUE (general fatigue) (seriousness criterion hospitalization prolonged), GAIT DISTURBANCE (trouble walking) (seriousness criterion hospitalization prolonged), MOVEMENT DISORDER (inability to lift right leg) (seriousness criterion hospitalization prolonged), HYPOAESTHESIA (hypoaesthesia) (seriousness criterion hospitalization prolonged), the second episode of LETHARGY (lethargy) (seriousness criterion hospitalization prolonged) and NAUSEA (nausea) (seriousness criterion hospitalization prolonged). On 19-Jun-2021, the patient experienced HEADACHE (experienced a headache describing that " an explosion happened in my head) (seriousness criterion hospitalization prolonged). On 20-Jun-2021, the patient experienced VISION BLURRED (blurred vision) (seriousness criterion hospitalization prolonged). On 21-Jun-2021, the patient experienced ERUCTATION (belching) (seriousness criterion hospitalization prolonged) and DIARRHOEA (diarrhoea) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (lightheadedness), DIZZINESS (dizziness), DRY MOUTH (drying of the mouth and throat), VERTIGO (vertigo), ERUCTATION (belching), DEHYDRATION (Dehydration), PARAESTHESIA (Tingling all the way to fingertips), FATIGUE (general fatigue), GAIT DISTURBANCE (trouble walking), MOVEMENT DISORDER (inability to lift right leg), HYPOAESTHESIA (hypoaesthesia), the last episode of LETHARGY (lethargy), HEADACHE (experienced a headache describing that " an explosion happened in my head), VISION BLURRED (blurred vision), DIARRHOEA (diarrhoea), NAUSEA (nausea), ANAPHYLACTIC REACTION (anaphylactic reaction), VACCINATION SITE BRUISING (vaccination site bruising), BLOOD PRESSURE INCREASED (blood pressure increase), PARAESTHESIA (paraesthesia left arm), DEHYDRATION (dehydration) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Blood pressure measurement: high (High) 172/95-98. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient has Coronary Artery Disease for which they Artery Disease for which they have three cardiac stents. The patient is RH negative. Company Comment: Based on the currently available information and temporal association between the use of the product and the start date of the immediate events following vaccination with a start date of 21May2021, a causal relationship cannot be excluded. Very limited information regarding the events with an onset date of 18Jun2021 and 19Jun2021 has been provided at this time. Further information has been requested and is necessary for assessing a causal relationship. This case was linked to MOD-2021-264136 (Patient Link).; Sender's Comments: Based on the currently available information and temporal association between the use of the product and the start date of the immediate events following vaccination with a start date of 21May2021, a causal relationship cannot be excluded. Very limited information regarding the events with an onset date of 18Jun2021 and 19Jun2021 has been provided at this time. Further information has been requested and is necessary for assessing a causal relationship.
64 2021-07-28 chest pain, blood clot -First night had a pain in my arm pit of the arm I received the shot -Second day still had a pain i... Read more
-First night had a pain in my arm pit of the arm I received the shot -Second day still had a pain in my arm pit and now chest pains, along with fatigue, chills and nausea sick like I had a flu, all my muscle and joint ached. I had a headache. -I was sick for the next four days in bed. -Fifth day still having chest pains, went to the ER were they ran test and found out I had blood clots in my lungs and my left leg, -
65 2021-01-02 chest discomfort, blood pressure increased Started approx 80 minutes after injection with soft palate swelling and throat fullness, followed by... Read more
Started approx 80 minutes after injection with soft palate swelling and throat fullness, followed by change in voice, and chest tightness with paresthesias. Went directly to ED. Sats were good, no wheeze, throat swelling was noted. BP initially 150/93, peaked at 189/93,. Was 148/67 at discharge. Received oral Benadryl and Zyrtec, IV dexamethasone and Pepcid. ECG was done, no other labs. Observed for approx 90 minutes with improvement of all symptoms. Did need to take additional Benadryl dose approx 5 hours after first dose for return of mild throat fullness and rising BP. Both resolved within 30 minutes of dose. No further throat symptoms, BP fluctuations for over 24 hours now
65 2021-01-02 heart rate increased, blood pressure increased Injection was at 12:00 Pm on 12/29/2020. At 12:20 PM i started to feel faint, slightly nauseous . I ... Read more
Injection was at 12:00 Pm on 12/29/2020. At 12:20 PM i started to feel faint, slightly nauseous . I layed down on my office floor, , my heart rate went up to 140 BPM and BP was around 140/76. My MA checked it . One of my physician colleague's that was nearby checked on me as well as the nurse that gave me the injections. it took about 30-40 minutes for the symptoms to subside. I was sent to our Urgent care dept in the same clinic by wheelchair at around 12:30-12:40 pm. I was evaluated and my symptoms subsided in 30-40 minutes. I was out of Urgent care at 1:25 pm, able to walk upstairs back to my office and felt okay and was seeing patients again at 1:30 PM. This reaction was similar to getting a shot of Novocaine w/ epinephrine for a dental procedure I received a few years ago, so if I were to sum it up it was like getting a shot of epinephrine. it was not a vasovagal reaction as my BP was high. I have felt fine since. I plan to get the second vaccine. Any suggestions to avoid these symptoms w/ the second one would be appreciated.
65 2021-01-03 body temperature decreased I work in health care and therefore was offered the vaccine. After about 1hr my hands, feet and nos... Read more
I work in health care and therefore was offered the vaccine. After about 1hr my hands, feet and nose became very cold and my temp dropped to 94 degrees. I felt very cold. My blood pressure was 90/30. This never happened to me before. It took about two hours for my temp to go back to normal and for me to feel my normal self. I had Covid 19 in August.
65 2021-01-04 chest pain, chest discomfort chest pain, shortness of breath, chest tightness, muscle pain. Symptoms started 5 minutes after vacc... Read more
chest pain, shortness of breath, chest tightness, muscle pain. Symptoms started 5 minutes after vaccine.
65 2021-01-04 fainting 12/31/20 extreme heavy drowsiness, sleepiness. Pt collapses and fell asleep after arriving home, Pt... Read more
12/31/20 extreme heavy drowsiness, sleepiness. Pt collapses and fell asleep after arriving home, Pt awoke 5-6 hrs later, feeling unwell body aches, headache, sinking feeling, restlessness , flushed feeling, 106. fever, loss appetite, bad taste in mouth weakness, congestions and Phlegm in lungs, sore arm also . Symptoms continue, feeing extreme restlessness and headache persists. Tylenol and ibuprofen taken for fever.
65 2021-01-08 blood pressure increased, heart rate increased, palpitations Headache, Palpitations, flushing, elevated blood pressure (134) and Heart rate (90) Narrative:
65 2021-01-08 palpitations, hypertension, heart rate increased Palpitations and accelerated hypertension. Blood pressure and heart rate remained high after an hour... Read more
Palpitations and accelerated hypertension. Blood pressure and heart rate remained high after an hour of monitoring so was sent to ED in same facility for follow up. Heart rate was 103 and Blood pressure was 157/85 (My normal BP is 110/62).
65 2021-01-09 chest discomfort Anigina Narrative: Patient received Covid 19 vaccination at 1513. Due to an allergy to honey bees,... Read more
Anigina Narrative: Patient received Covid 19 vaccination at 1513. Due to an allergy to honey bees, she was monitored by RN for 30 minutes, ended 1543. When observation period was completed, RN asked patient if she was okay. Employee stated, "I'm having some tightness in my chest, but I'm okay." Employee also stated that she sometimes has SOB and tightness of chest. Vital signs obtained BP 185/82-P 77- R 20- O2 sat 100% room air, T 97.4. BP rechecked 206 /85. Employee asked by staff if she has hypertension, stated yes. Asked by this writer when was the last time she had taken BP medications and she stated today before lunch. Advise that EMS will be notified that she could go to hospital, employee refused. Leadership notified of situation and advised that nursing staff still call 9-1-1. 1554 9-1-1 notified via telephone by RN. Employee asked if any history of heart attack, denied however did disclose history of four heart stents. Approximately 1606 EMS arrived to building 6 to escort employee to hospital, patient refused to go to hospital. Leadership at vaccination clinic, advised employee call 9-1-1 or go to nearest hospital if tightness in chest persist, expressed understanding.
65 2021-01-10 hypotension Pt reports that initially, immediately after the injection she had dizziness and hypotension. She r... Read more
Pt reports that initially, immediately after the injection she had dizziness and hypotension. She reports history of allergic reactions to injections and had her Epi Pen ready, but did not need to use it. They gave her water and a Tylenol at the vaccination site as well as a Claritin. Pt denies rash , tongue swelling, or difficulty breathing. Does not know what her BP was when they told her she had hypotension, but did not require ED treatment. She recovered and was able to return home after an hour.
65 2021-01-11 chest discomfort Injection around 9:25am. She became dizzy at 9:30am in the chair in the waiting area after vaccine. ... Read more
Injection around 9:25am. She became dizzy at 9:30am in the chair in the waiting area after vaccine. Juice provided as well as water. @9:30 her BP was 120/88 Pulse 70. Pt talking. Felt slightly better after juice- still a bit shaky and dizzy. At 9:56 am she still was not feeling right- stating head heavy and now her chest had a tightness in the center- still Alert and oriented. BP recheck was 160/96 in left and 160/100 in right with a pulse of 88. 911 was called at this time. Ambulance arrived and patient went to the ER at 10:15am
65 2021-01-11 heart rate increased, blood pressure increased Moderna COVID-19 Vaccine EUA I had rapid heartbeats (over 140/minute and difficulty breathing after ... Read more
Moderna COVID-19 Vaccine EUA I had rapid heartbeats (over 140/minute and difficulty breathing after got first dose of Moderna vaccine. Please see below for more details: After I got a first dose of Moderna vaccine around 9:30am on Jan 09, 2021, my heartbeat rate quickly went up to over 140/minute, my blood pressure was above 140/90+; I felt hard to breath but my oxygen level was 100%. These were happened within 15 minutes after the vaccine shot. The Healthcare team/rescue team helped me and let me practice deep-breathing. After practiced deep-breathing about 5 - 15 minutes, my heartbeats reduced to around 80 - 90/minutes and my blood pressure went back to normal about 120/75. I left the clinic around 10:25am.
65 2021-01-11 hypertension, palpitations, blood pressure increased, heart rate irregular Palpitations, HYPERtension, flushed, increased BP, irregular HR Narrative: Stated that 5 min afte... Read more
Palpitations, HYPERtension, flushed, increased BP, irregular HR Narrative: Stated that 5 min after vaccine started feeling flush, BP was 40-50 points above usual baseline for individual. Went home and rested. Still felt awkward while at home. used apple watch and noted irregular HR on EKG feature. Noted that BP and heartrate returned close to baseline 6 hours post vaccine without use of medication.
65 2021-01-11 fast heart rate Headache, Myalgia, Fever & Tachycardi
65 2021-01-12 palpitations Approximately 23 minutes after receiving vaccine employee experienced "heart racing". Pulse 110.
65 2021-01-13 hypertension High blood pressure , it went up to 153/96 last night. Before the shot it was 124/84
65 2021-01-14 chest discomfort Moderna: one giant hive on my left shoulder; swelling, redness (approximately 2"x3"); extremely sore... Read more
Moderna: one giant hive on my left shoulder; swelling, redness (approximately 2"x3"); extremely sore; horrible horrible itching; the center of the red spot was hard and hot. The redness went down my arm to my inner elbow down my forearm to my wrist. The redness going down my arm was not as bad after I took the Allegra. It was all extremely painful. I had to go see Dr. because the itching was so bad. Dr. prescribed medicine for the swelling/itching. At times my throat was sore and my face was flushed and I had a tightness in my chest. But that did not last long.
65 2021-01-14 pallor Reported pain, swelling, and erythema LUE at injection site. Exam revealed blanching erythemic patch... Read more
Reported pain, swelling, and erythema LUE at injection site. Exam revealed blanching erythemic patch with diffuse borders. Advised follow up with PCP for assessment.
65 2021-01-14 palpitations SOB, Pain in neck, nausea and palpatations
65 2021-01-14 lightheadedness, blood pressure increased Immediate sensation of slight mental status change which resolved but within 2 minutes started to fe... Read more
Immediate sensation of slight mental status change which resolved but within 2 minutes started to feel slightly woozy and pre-syncopal, as if anaphylaxis starting. Informed staff. Put on stretcher. Vital signs obtained. O2Sat upper 90s. BP elevated with diastolic in low 100s with sensation of pre-syncope and very slight confusion. Resolved slowly over 30 minutes to about 90% of prior mental status. Continued to feel somewhat dizzy for several hours. Went to bed early. Had very intense disturbing dreams. Very sore vaccine site. Resolved by morning. Arm soreness about 50% of day prior.
65 2021-01-16 blood pressure increased Within 10 minutes of getting the shot I noticed a progression of symptoms that increased and got wor... Read more
Within 10 minutes of getting the shot I noticed a progression of symptoms that increased and got worse. I got very hot. I was sweating. I was very light headed. I got a headache. I was nauseous. I believed I was going to faint. My blood pressure spiked. I noticed getting hotter and hotter within 5 or 10 minutes of the shot. I removed some outer clothing, but I still kept getting hotter. Then I noticed I was very light headed. Then I noticed I was sweating. I was very clammy and later on, a woman attendant said she could see the sweat on my. The headache began in the back of my neck. I thought I was going to faint. I because nauseous. My thinking became unclear. After about 15 minutes of this continuing to get worse, I called over the paramedics. They took my blood pressure and said it was very high. They checked my heart beat, oxygen level, lungs, and blood pressure. They checked my blood pressure again, and then again maybe 15 or so minutes after the second time and they reported to me that it was going down. I continued to not feel well and the worst of it lasted for about an hour and now, 2 full days later I still do not feel well. Yesterday, 1 day after the shot, I barely got off the couch. Today, my vision is blurry, I am still light headed, and still feel dizzy. My headache has diminished. My thinking is still foggy. I do not feel safe to drive. As far as treatment, I just sat still. I had eaten breakfast and lunch (ate lunch within an hour of the shot, but was given a ginger all and 2 cookies, which I ate. After I felt well enough to get up, I walked around the facility for a few minutes, then I went outside in the cold fresh air and continued to walk for a bit. I then drove home and stayed on the couch. I do want to state (and no where on here does it ask about this) so I am putting it here: I have only ever gotten a small pox and polio vaccination as a child, a Hep B shot four decades ago, and tetanus/whooping cough shots. I also take no medications and throughout my lifetime I have only taken a few. So, when the early pre-vaccine assessments ask about allergic reactions to injections of vaccines, I answered no because I barely ever had any. No pre-vaccination assessments also said that no adverse reactions to oral medications were a problem. And there was no where in the early assessments to give u that info. I did say, yes, about having immune system issues on the online assessment, and I told the attendant at the time of check in. It is unidentified as far as it having a name, but I have seen a Rheumatologist last spring and she ruled out Lupis. I get sick easily with colds, so I believe I have a weak immune system.
65 2021-01-17 chest discomfort Moderna Vaccine Reaction: 12/30/2020 vaccinated Moderna vaccine at 2:15pm – no issues 12/31/2020 ex... Read more
Moderna Vaccine Reaction: 12/30/2020 vaccinated Moderna vaccine at 2:15pm – no issues 12/31/2020 experienced chest tightness at 8am resolved with albuterol 1/1/2021 awakened from a nap at 3 pm with hot itching rash across front of chest & back of neck. Eyelids slightly reddened and swollen. Allergic to IV Benadryl (total body rash after given IV push Benadryl to get MRI claustrophobic). No benadryl. Routinely take Zyrtec daily that had been taken. Took extra strength Tylenol and pushed fluids. Through the day slowly improved. 1/2/2021 Rash almost gone no longer itching. Eyelids only slightly red. 1/3/2021 Used antihistamine eyedrops once. Later no longer red.
65 2021-01-17 palpitations, atrial fibrillation, heart flutter PATIENT RECEIVED VACCINE 1/7/21 AT 1000. THE NEXT DAY, PATIENT PRESENTS TO ER ON 1/13/21 WITH COMPLA... Read more
PATIENT RECEIVED VACCINE 1/7/21 AT 1000. THE NEXT DAY, PATIENT PRESENTS TO ER ON 1/13/21 WITH COMPLAINTS OF PALPITATIONS AND DIZZINESS OCCURING SINCE HER FIRST DOSE OF VACCINE. "The patient states she has had these episodes for the last 6 days and they started when she got her COVID vaccine. The patient states she has had numerous episodes over the last 6 days of this that lasts between 2 and 4 hours. The patient can feel her heart fluttering and she gets a little dizzy with it. The patient has not had any nausea, shortness of breath or chest pain with these episodes however. The patient has not had any prior episodes of this. The patient takes no regular medications apart from vitamins." PATIENT WAS DIAGNOSED WITH NEW FOUND A. FIB WITH RVR. ADMITTED TO HOSPITAL FOR OBSERVATION. PATIENT RETURNED TO NORMAL SINUS RHYTHM THE NEXT DAY AFTER INITIATING DILTIAZEM AND ELIQUIS.
65 2021-01-17 fast heart rate nausea and vomiting possible cause of diabetic ketoacidosis and svt
65 2021-01-18 heart rate increased 11 hours after the shot I woke up with chills, fever, aching, headache, dizziness, elevated heart ra... Read more
11 hours after the shot I woke up with chills, fever, aching, headache, dizziness, elevated heart rate 113 beats per minute( i take Atenolo so my heart rate rarelly gets above 70 bpm).
65 2021-01-18 heart rate increased Bronco spasms, racing pulse, anxiety Treatment was Xanax, nebulizer, prednisone
65 2021-01-19 heart rate increased, hypertension Chest Pain, High fever, chills, high blood pressure, high pulse, headache, weakness, stomach pain
65 2021-01-19 hypertension, fast heart rate The day following the vaccination, developed high blood pressure and tachycardia.
65 2021-01-20 palpitations, chest discomfort My arm is still red and hot and it's beginning to itch. Immediately after the vaccine my face got ho... Read more
My arm is still red and hot and it's beginning to itch. Immediately after the vaccine my face got hot and bright red as it does when I have an allergic reaction. My heart rate raced and chest felt weird, but immediately I had tingling in my left arm from the vaccine. I was winded when speaking for about 24 hours. When I got home, I began taking Benedryl. My arm still has a hard knot and is still red and hot. I'm trying to find out what to do about the red, fever at injection site and the redness. It's starting to itch. This has been 10 days ago that I had the vaccine. I'm not an antivaxxer and look forward to my second vaccine on February 8, but I'm a little apprehensive.
65 2021-01-21 palpitations, heart rate increased Client presented stating she felt like her heart was racing. Initial pulse 120 S/R. Talked for a few... Read more
Client presented stating she felt like her heart was racing. Initial pulse 120 S/R. Talked for a few minutes and client stated no itching or shortness of breath. After 5 minutes pulse 86 S/R. After 10 minutes pulse 78 S/R. Client stated normal resting heart rate of 65. She takes 12.5mg HCTZ PO daily.
65 2021-01-21 palpitations Client presented stating she felt like her heart was racing. Initial pulse 120 S/R. Talked for a few... Read more
Client presented stating she felt like her heart was racing. Initial pulse 120 S/R. Talked for a few minutes and client stated no itching or shortness of breath. After 5 minutes pulse 86 S/R. After 10 minutes 78 S/R. Client stated normal resting HR of 65. She takes 12.5 HCTZ PO daily.
65 2021-01-22 heart rate increased, hypertension Enable to make sleep headaches ,GI,elevated temp.and extreme fatigue ,rapid heartbeat
65 2021-01-23 blood pressure decreased At 45-50 minutes after my injection I was walking and felt my blood pressure bottom out. I stumbled... Read more
At 45-50 minutes after my injection I was walking and felt my blood pressure bottom out. I stumbled and felt as if I was going to faint. I recovered quickly. Once home I monitored my blood pressure and it was low. The lowest reading was 88/70. I laid down and within a couple hours my pressure was more normal. I did not feel faint at that time. I have severe anxiety and am not sure if that contributed to this episode. Additionally, my blood pressure is on the low side of normal.
65 2021-01-24 fainting Grade 3 systemic reactions, much worse than the first time. Injection site (right arm) pain, swellin... Read more
Grade 3 systemic reactions, much worse than the first time. Injection site (right arm) pain, swelling. Overall body pain, skin, muscle joint, Fever up to 101.6 for 36 hours, now running 99.5 on day 2 post injection, nausea, diarrhea, gas, bloating, dizziness, weakness, fainting, fatigue. Unable to function or to work. Symptoms are again substantially worse than 10 other individuals vaccinated at the same time for dose 2. I suspect my reactions may be dose to weight dependent. I am a very small adult, 4'9", 123 pounds. There may be cause to consider smaller doses for smaller people. That would also allow more doses to be available for the population. I am a healthcare professional. Many lay people would probably not have been willing to take a second dose at this level of reaction.
65 2021-01-25 palpitations, chest discomfort, hypertension Moderna COVID-19 Vaccine EUA. Received first COVID vaccination Fri., Jan. 22 at 1:56pm. I was not an... Read more
Moderna COVID-19 Vaccine EUA. Received first COVID vaccination Fri., Jan. 22 at 1:56pm. I was not anxious about the shot at all and was playing solitaire on my cell phone when around 2:15pm it was like a switch turned on and I felt my heart racing and pressure on my chest. I notified the nurse and she took my blood pressure and it was 200/90, HR 98, Oxy 100%. At 2:25pm it was 140/80, HR 96, Oxy 96%. And at 2:39pm it was 132/88 and the nurse felt it was OK to return home. My chest felt better at home around 4:15pm that same day. I definitely had no anxiousness about taking the COVID vaccine, and was not worried about a reaction at all. Having that high of a blood pressure was a surprise because my blood pressure is usually around 117/74, and I don't get anxious about allergy shots or vaccinations. I have been taking allergy shots for over 15 years every month. I had taken my allergy shots in both arms 2 days prior to the COVID vaccination that was ok'd by my clinic.
65 2021-01-26 heart rate increased 1320 Patient here for Moderna Covid Injection; states "I'm feeling really anxious about this injecti... Read more
1320 Patient here for Moderna Covid Injection; states "I'm feeling really anxious about this injection" Moderna Injection discussed with patient including risk associated with injection; allergies noted; patient states "I want the vaccine rather than get covid". 1323 Moderna vaccine given, patient encouraged to wait 30 minutes after receiving Moderna vaccine, with patient verbalizing understanding through teach back. 1330 Nurse at patient's side, patient state's I'm feeling okay, thanks"; patient's husband at side 1346 patient c/o of fast heart rate; pulse taken with 90 bpm noted; pharmacist at side and RRT notified and at side. 1350 Rash noted on patient's neck, face is flushed and patient complains of lips burning. doctor notified of patients complaints and instructed to tell patient that she can go to the ER if symptoms persist with patient verbalizing understanding through teach back. 1351 Benadryl 25 mg given po as ordered; wash cloth applied to patient's face. 1400 Patient states "I'm not feeling any better, I would like to go to the ER", patient taken to ER. -------------------------------------------------------------------------------
65 2021-01-27 hypertension Reported feeling jittery and nervous, overall just "not feeling right". Hypertension.
65 2021-01-27 hypotension, pallor PATIENT WAS SWEATING. SHE LOOKS PALE AND WAS COLD. SHE INDICATED HER SIGHT BLURRED. AFTER 45 MINUTES... Read more
PATIENT WAS SWEATING. SHE LOOKS PALE AND WAS COLD. SHE INDICATED HER SIGHT BLURRED. AFTER 45 MINUTES SHE WAS FINE.
65 2021-01-30 chest discomfort 40 minutes after receiving vaccine my throat constricted, chest tightened, had difficulty swallowin... Read more
40 minutes after receiving vaccine my throat constricted, chest tightened, had difficulty swallowing and catching my breathe. Returned to Convention Center, site of vaccination. Paramedics took vitals, determined I was having a "minor" allergic reaction and administered Benadryl. Within 20 minutes of receiving Benadryl, I was able to breathe and swallow without difficulty. No further complications afterwards.
65 2021-01-30 hypertension H/O anxiety & HTN- felt anxious and hot. D/C calm and seemed fine.
65 2021-01-30 fast heart rate Approximately 2 hours later, tachycardia 120-130 bpm for 3 hours. Also, when checked BP 80-90/ 40-50... Read more
Approximately 2 hours later, tachycardia 120-130 bpm for 3 hours. Also, when checked BP 80-90/ 40-50 running concurrently with the tachycardia.
65 2021-01-31 hypertension, blood pressure decreased Nausea. Dizziness. Almost passed out. Unresponsive, out of body type of experience. Could not t... Read more
Nausea. Dizziness. Almost passed out. Unresponsive, out of body type of experience. Could not talk ir move for a minute or so. I knew my mouth was hanging open and couldn't shut it. My husband took my blood pressure, it was 61/50. After a few minutes I was coming to, blood pressure began to come back up. My husband had called 911 when my blood pressure dropped so low. By the time they arrived it was back up to normal. I have never had any problems with blood pressure, low or high. Or with dizziness, fainting etc. I am very sure it was from the vaccine
65 2021-02-01 heart rate increased, palpitations Vaccinated at 1:20 PM on 1/26/2021. Approximately 15 min later I was in the waiting area, the nurse ... Read more
Vaccinated at 1:20 PM on 1/26/2021. Approximately 15 min later I was in the waiting area, the nurse had been pre-notified to watch me for allergic reaction . In 15 minutes my symptoms were fast heart rate, lips burning, dark red facial flushing, ears flushing, and anterior neck flush, body tremors, a rapid response team notified to evaluate me. I was administered a 25 mg Benadryl tablet per mouth. I felt stabilized and chose to go to the ER within the building for further evaluation. Remaining stabilized, had a 4 hour wait until I was seen by emergency staff. My treatment was Solumedrol IV, Pepcid IV and Benadryl 25 mg po. I was placed on a heart monitor and a pulse oximeter to check my oxygen levels the entire time I was in the ER. 4 hours prior to being seen by the ER doctors I had a CBC, a BMP blood work, and an EKG. After medications were administered I was observed approximately 1.5-2 hours. I was discharged with a 5 day medicine regimen to follow. Prednisone 40 mg per day; Pepcid 40 mg per day; Benadryl 25 mg every 6 hours. On 1/27 I chose to take the Benadryl 25 mg only because I had received the Pepcid and Prednisone the previous night late. On the 28th I took the medicine as prescribed but only took Benadryl every 12 hours. I felt Benadryl 4 times a day would not be handled well with my body. On 1/30 I was able to take the Pepcid and Prednisone but had to discontinue the Benadryl due to waking up with a spinning sensation upon opening eyes and a loss of equilibrium upon walking. I completed my medicine regimen on 2/1. Today 2/2 I woke up with symptoms of watery eyes, flushed face, mild facial itching, after drinking one cup of full caffeine coffee developed an increased heart rate and nervousness, was medicated with Benadryl 25 mg po at 10:00 AM along with my blood pressure medicine and potassium. Also at that time my blood pressure was 150/80. Three hours later my blood pressure had come down to 130s/60s but felt extreme weakness and felt the need to lay down and rest with legs elevated. I continue with my day with increased heart rate with activity, so I have remained inactive for the rest of the day. Also on 6:00 AM on 1/27 I was awakened with a heart rate In the 160s, I called 911, paramedics came 5 minutes later. On arrival my heart rate had instantly went down to the 112-120 range. The paramedics explained they have been treating COVID patients and have seen this a lot, we discussed going to the hospital but I felt I was stabilized and didn't need further treatment. Also upon discharge from ER visit they had me get 2 epi-pens and I now have 2 epi-pens available at home.
65 2021-02-02 body temperature decreased Arm is swollen and warm with a large erythematous rash below injection site. Several oral temperatu... Read more
Arm is swollen and warm with a large erythematous rash below injection site. Several oral temperature readings 95 and below. My husband called 911 after an hour of extreme dizziness, weakness, and chills. I knew I was going to pass out if he tried to get me up.
65 2021-02-02 fainting Syncope 20 hrs after vaccine. Swollen glands 32 hrs after vaccine. Rash on right upper arm 48 hrs a... Read more
Syncope 20 hrs after vaccine. Swollen glands 32 hrs after vaccine. Rash on right upper arm 48 hrs after vaccine.
65 2021-02-03 chest discomfort Vaccine recipient stated she felt hot in her chest and face upon parking after her vaccination was g... Read more
Vaccine recipient stated she felt hot in her chest and face upon parking after her vaccination was given. She stated she didn't quite feel light headed or dizzy but she felt weak. Vitals were taken and within normal ranges. VR was given a longer observation time and was given water. Upon 30 minutes of observation she stated she felt better and safe enough to leave.
65 2021-02-04 nosebleed Roughly 8 hours later: Felt what seemed like Severe acid reflux in belly, chest neck and head. Then ... Read more
Roughly 8 hours later: Felt what seemed like Severe acid reflux in belly, chest neck and head. Then I felt left arm muscle where injection; then I noticed whole body aching; fatigue,; then nose bleed; then I was super chilled/shaking; then legs aching. Dry mouth, thirsty. Today, roughly 22 hours later, all body aching, glands tender, neck achy, small headache; extreme weakness and feeling like flu and still queasy. Not functional for normal task.
65 2021-02-04 hypertension Patient receive COVID vaccine 1, went to observation area and "jerking upper and lower extremities" ... Read more
Patient receive COVID vaccine 1, went to observation area and "jerking upper and lower extremities" after sitting. Code Assist called, patient was hypertensive at 182/108, with saturations of 100% on RA. Was transported to Urgent Care in same facility. By that time, she was alert, appropriate, seemed to have a left facial droop. Secondary to apparent seizure and hypertension, decision to transport by 911 was made. Patient did leave the Urgent Care area with paramedics but later decided to go home instead. She spoke with her primary care provider today, 2/5/21.. At that time patient revealed that she was taking zonisamide but not keppra, as prescribed
65 2021-02-04 fainting INTENSE CHILLS, BODY ACHES, NAUSE, FATIGUE, SLEEPINESS,LOSS OF APPETITE. FAINTED-YES FAINTED FALLING... Read more
INTENSE CHILLS, BODY ACHES, NAUSE, FATIGUE, SLEEPINESS,LOSS OF APPETITE. FAINTED-YES FAINTED FALLING BACK AND HITTING MY HEAD ABOUT 3 AM IN MORNING. I AM ON WARFARIN FOR BLOOD CLOTS
65 2021-02-05 chest pain, heart rate increased Nausea, arm, neck, chest , jaw pain, chills, fast heart beat
65 2021-02-05 hypertension Vaccinee was in 15 min observation area and just before that time was up, she called for the Nurses ... Read more
Vaccinee was in 15 min observation area and just before that time was up, she called for the Nurses because she "was feeling lightheaded and her hands were tingling". She was talking but seemed alarmed. Lungs were clear BP was 148/98 which is high for her. EMS on site and called over to respond. They transported her to hospital and en route gave Epi and Bendaryl IM, she was further treated at the ER. She was discharged home at about 6pm.
65 2021-02-05 palpitations Immediate heart racing (about 10 minutes). Immediate Numbing/tingling lips (about 10 minutes) 5 minu... Read more
Immediate heart racing (about 10 minutes). Immediate Numbing/tingling lips (about 10 minutes) 5 minutes after severe itching in hand (1 1/2 hours). 2 days after injection Gland swelling (lasted about 2 weeks)
65 2021-02-07 cardiac arrhythmia, chest pain I develop PVCs about 11hrs post vaccination along with other common symptoms. PVCs have continued to... Read more
I develop PVCs about 11hrs post vaccination along with other common symptoms. PVCs have continued to present. 8 days post vaccination I developed chest pain with the PVCs.
65 2021-02-08 palpitations, chest discomfort Heart pounding, dizziness, exhaustion, tight chest, flushed (no fever), out of breath
65 2021-02-09 chest discomfort chest tightness and cough, no wheeze
65 2021-02-09 hypertension Pt became flushed and red, hypertensive
65 2021-02-09 hypotension, heart rate decreased My mom is 65 years old and received the first dose of Moderna's vaccine last Saturday, 2/6. On Tuesd... Read more
My mom is 65 years old and received the first dose of Moderna's vaccine last Saturday, 2/6. On Tuesday, 2/9 (three days after the vaccination), she saw red and purple bruises across her left arm - the arm where the vaccine was injected. Nothing occurred to cause the bruises across her left arm. There was also one large bruise on her left leg but that was caused by bumping her leg into an object. My mom went to her PCP today for bloodwork. We hope to get results from Quest tomorrow. My mom has received various vaccinations throughout life and this reaction is unprecedented. The day after she received the COVID-19 vaccine, she had a fever, dizziness, low blood pressure and slow heartbeat. All these side effects disappeared by Tuesday (three days after vaccination) but the bruises appeared.
65 2021-02-10 blood pressure decreased Shivers, blood pressure reduced, cold, tired.
65 2021-02-10 blood pressure increased Arm tender for two days, ran a fever, body aches and headache for 12 hours. Blood pressure went up t... Read more
Arm tender for two days, ran a fever, body aches and headache for 12 hours. Blood pressure went up to 187/101.
65 2021-02-10 cardiac arrest Patient had the first Moderna Covid vaccine on Thursday 1/21/2021. She had a bit of sore arm on tha... Read more
Patient had the first Moderna Covid vaccine on Thursday 1/21/2021. She had a bit of sore arm on that day and the day after. On Saturday 1/23/2021, she had a fever of 100.5 F (11AM), nausea, light headache and chills. The temperature went down after she took ibuprofen. Patient's husband enrolled her to V-Safe to report all the adverse effects she experienced. On Sunday 1/24/2021, her temperature was 98.3F. She still had nausea and no appetite. She and her husband watched a football game in their bedroom upstairs. Husband noticed that his wife was pacing around the room many times. At 7Pm, Husband went downstairs for dinner but she refused to come down to eat. He went upstairs around 8pm, TV was still on. He turned off TV and went down stairs again thinking his wife felt as sleep while watching TV. He went back upstairs for bed around 10:30 PM. Husband said his wife had a deviated septum so she would snore very loudly when asleep. He didn?t hear her snoring so he went to check on her and found her not responsive. Husband called emergency services. Paramedic came at 10:45 and said patient was passed. Husband sent many texts to V-safe after that to report the incident. No response was received from V-safe. Patient?s doctor told her husband that she died due to cardiac arrest.
65 2021-02-10 heart rate increased Dizziness, light headed within first 10 min. but continued Fast heartbeat - 5 hrs later while walkin... Read more
Dizziness, light headed within first 10 min. but continued Fast heartbeat - 5 hrs later while walking around house Itching all over body, face, head, light rash in thorax and inner tights- 8 hrs later Dizziness and weakness continues on 2-11-21
65 2021-02-10 palpitations Patient received the Moderna Covid 19 EUA vaccine @9:59, at 10:30 reported heart racing & palpitaito... Read more
Patient received the Moderna Covid 19 EUA vaccine @9:59, at 10:30 reported heart racing & palpitaitons. Vitals: 10:35 135/80 HR 75 O297%, 10:40 150/82, HR 71, O2 96%, 10:50 136/86, HR64 O296% Patient history of diabetes, takes Glipizide and Hypertension, takes Bystolic. Patient reported she was very nervous about vaccine. Patient reported feeling better by 10:50 with no more palpitations and was released home with her spouse.
65 2021-02-11 chest pain About 10 minutes after vaccine patient reported shew as dizzy and felt nauseous. Her blood pressure ... Read more
About 10 minutes after vaccine patient reported shew as dizzy and felt nauseous. Her blood pressure at the time was 104/60, hr 76 and regular, SPo2 was 98% on RA. she was assisted to lay down. Her blood pressure and vitals were checked again and were 90/60, HR 78, SPo2 95% on RA. She complained of chest pain. EMS was called. they arrived at about 145pm and transported her to Hospital per the patient's request. She remained conscious, alert and responsive through the episode.
65 2021-02-11 nosebleed nose bleeds on left nostril for 3 days over 30 minutes, chills, felt sedated
65 2021-02-11 loss of consciousness Severe flu like systoms with nausea and cramping. Lightheaded, clamy, cold to the touch. No fever. ... Read more
Severe flu like systoms with nausea and cramping. Lightheaded, clamy, cold to the touch. No fever. Passed out 3 times - per my husband trying to go the bathroom. These systoms lasted from 10.30 pm till 8.00am the next morning. Severe nausea continued and my doctor prescribe ondansetron. This is the sickest I can remember being in my life. I am very concerned about me passing out.
65 2021-02-11 lightheadedness Vasovagal reaction
65 2021-02-12 heart rate increased, chest discomfort Chest tightness, hot & cold, fast pulse, itchy red rash on both arms Benadryl 2 capsnone
65 2021-02-12 heart rate increased Rapid heartbeat just lying in bed; fatigue, achy, low grade temp (100 F); chills. Events began in th... Read more
Rapid heartbeat just lying in bed; fatigue, achy, low grade temp (100 F); chills. Events began in the early morning hours and continued through most of the day. Felt very tired and not able to do much of anything. Spent the day napping and lying around.
65 2021-02-12 fainting, heart flutter, hypotension, palpitations On the 01/06/2021 I noticed that I had a fever of 100.9 I was really fatigued . I Thinking I was ok... Read more
On the 01/06/2021 I noticed that I had a fever of 100.9 I was really fatigued . I Thinking I was okay . I went to visit the nail shop and fainted.. I was rushed to the hospital . My heart was fluttering and racing . My blood pressure was also low .
65 2021-02-13 body temperature decreased, fast heart rate, heart rate increased Severe vomiting for 12 hours (unable to keep down food or water), lowered body temperature, rapid he... Read more
Severe vomiting for 12 hours (unable to keep down food or water), lowered body temperature, rapid heart rate and tachycardia, headache. No fever or chills or body aches. These are the identical symptoms for me, patient, for sulfite reactions.
65 2021-02-13 chest pain 8 days after vaccination, site became red and swollen and itchy. Also have a headache, chills, and f... Read more
8 days after vaccination, site became red and swollen and itchy. Also have a headache, chills, and flu like; chest wall following double mastectomy 6 years ago suddenly became painful and itchy. Not sure if this delayed reaction is because I had an injury on my hand on day 8?
65 2021-02-13 heart rate increased, blood pressure increased Blood pressure and pulse rate went up and I felt woozy for a couple of hours, never dangerously high... Read more
Blood pressure and pulse rate went up and I felt woozy for a couple of hours, never dangerously high, but high for me. Then got flu like symptoms of headache, congestion of head, fatigue, chills, fever, muscle and joint pain, weakness walking. 2nd day arm fever, rash, hard knot, itching.
65 2021-02-15 cerebrovascular accident Stroke with right upper extremity weakness. Weakness improved, has mild residual weakness at this t... Read more
Stroke with right upper extremity weakness. Weakness improved, has mild residual weakness at this time. That still may improve in the coming months.
65 2021-02-15 heart rate increased Chills; headache, dizziness, fatigue; sleepiness, weakness, neckache, eye ache, rapid heartbeat, lo... Read more
Chills; headache, dizziness, fatigue; sleepiness, weakness, neckache, eye ache, rapid heartbeat, loss of appetite, nausea, hallucinations, cold sore. Symptoms resolved 48 hours after injection. Ibuprofen was taken to relieve headache and neck ache.
65 2021-02-15 hypertension 1 day after, prickling feeling under skin, that moves around my body. kind of makes it itch, day... Read more
1 day after, prickling feeling under skin, that moves around my body. kind of makes it itch, day of vaccine at facility. Blood pressure got high, flushing in face and chest. general weakness in legs. That night some nausea, and a slight headache. NO fever ever. Still have prickling feeling and this is day four.
65 2021-02-15 palpitations, chest discomfort 1/31/21 - 5 PM occasional heart racing. Restless sleep that evening. 2/1/21 through 2/03/21- Heada... Read more
1/31/21 - 5 PM occasional heart racing. Restless sleep that evening. 2/1/21 through 2/03/21- Headache 2/1/21 through 2/2/21 - Loose stool and some slight nausea from time to time. 2/1/21 started feeling a bit off balance and dizzy especially when first standing up. This still happens occasionally as of 2/16/21. 2/7/21 felt pressure in chest and difficulty catching a deep breath. Feel like I'm not getting a comfortable amount of oxygen although I am able to breathe normally without wheezing or catching my breath. This is still the case today 2/16/21
65 2021-02-17 blood pressure increased Post vaccination, patient began to experience itching of face, neck, L arm and eventually back and l... Read more
Post vaccination, patient began to experience itching of face, neck, L arm and eventually back and legs. BP initially 146/101, 5 minute re-check - 156/96, HR 105. Benadryl 50mg PO administered. BP continued to remain elevated. itching improved within 30 minutes. Remained at clinic. BP still elevated but instructed on importance of calling MD when she got home. Telephone call to patient today. she reports fever of 100, dry heaves, weakness chills and can't get out of bed. She stated BP was better when she got home at 140/80. States she feels like she has the flu. Instructed again on necessity to call MD today for further guidance for follow up or testing. Will follow-up with patient on 2/19/21.Unsure if she will require an MD visit at this time.
65 2021-02-17 oxygen saturation decreased chills weakness o2 dropped to 89 slight fever inability to stand labored breathing stomach upset fal... Read more
chills weakness o2 dropped to 89 slight fever inability to stand labored breathing stomach upset falls trying to stand, unable to get back up At this point transported to ER by ambulance Treated in ER and released
65 2021-02-17 ventricular tachycardia, pallor, hypotension Pt began having nonstop vomiting and diarrhea at 730am the day after vaccination, February 17th. Per... Read more
Pt began having nonstop vomiting and diarrhea at 730am the day after vaccination, February 17th. Persisted for over 24 hours so patient came to ER. Pt found to be in a ventricular tachycardia and hypotensive. Pt pale and cool and sts "its hard catching my breath". Pt becoming less responsive and required emergency intervention to stabilize her heart rate and blood pressure. Pt had multiple medications, IV fluids and ultimately emergent cardioversion to stablize heart rhythm.
65 2021-02-18 blood pressure increased, blood pressure fluctuation Elevated and erratic blood pressure, accompanying headaches, first noted 3 days post vaccination but... Read more
Elevated and erratic blood pressure, accompanying headaches, first noted 3 days post vaccination but may have started sooner
65 2021-02-18 palpitations Had very sore arm with some swelling. The nausea, headaches, extra fatigue, some heart racing, etc O... Read more
Had very sore arm with some swelling. The nausea, headaches, extra fatigue, some heart racing, etc Overall unwell feeling has lasted. some parts of a day can get better.I feel much like I went backwards with lyme disease-
65 2021-02-19 arrhythmia I developed Atrial Flutter. I have never had any cardiac issues my whole life. I have had EKG?s and... Read more
I developed Atrial Flutter. I have never had any cardiac issues my whole life. I have had EKG?s and have always been Sinus Rhythm. I am an RN. I put myself on a cardiac monitor at work and captured several tracings of Atrial Flutter.
65 2021-02-20 palpitations, blood pressure increased, heart rate increased Palpitation-pt verbalized heart beating fast. 11:32 BP 165/71 HR 70 96% saturation 11:40 BP 165/78 ... Read more
Palpitation-pt verbalized heart beating fast. 11:32 BP 165/71 HR 70 96% saturation 11:40 BP 165/78 HR 72 97% saturation pt has instructed to follow up with PCP with me elvated BP verbalized understanding pt verbalized subsiding of the symptoms pt was driven home by family member in no distress.
65 2021-02-21 blood pressure increased Patient had an allergic reaction . Onsite EMS was called vitals BP 154/56 97% O2 room air HR 58 P... Read more
Patient had an allergic reaction . Onsite EMS was called vitals BP 154/56 97% O2 room air HR 58 Patient treated, released home against medcial advice.
65 2021-02-21 heart rate increased Rapid heartbeat of 135 bpm Blood pressure 176/110 No treatment Symptoms resolved themselves after ... Read more
Rapid heartbeat of 135 bpm Blood pressure 176/110 No treatment Symptoms resolved themselves after 1 hour
65 2021-02-21 palpitations Seven hours after shot, while lying in bed, had pounding and racing heart for 2.5 hours. Did not ca... Read more
Seven hours after shot, while lying in bed, had pounding and racing heart for 2.5 hours. Did not call doctor because it was in the middle of the night and racing did stop. Now, continue to feel weak and fatigued, 70 hours after shot. Spoke to doctor's office this morning. Advised me to keep hydrated and take Tylenol if needed.
65 2021-02-22 blood pressure increased Adverse Event/Reaction: Symptoms including time of vaccination and onset time of symptoms: Felt di... Read more
Adverse Event/Reaction: Symptoms including time of vaccination and onset time of symptoms: Felt dizzy shortly after vaccine. Was driven over to the 30' lot. History of high BP. She had taken her BP in the am, BP was normal in the am. History of allergy to green chiles with throat and tongue swelling After about 10', she reported that she felt her tongue was swollen, she had minor speech difficulties and intermittent clearing of throat. Different speech pattern. RRR not tachy, lungs clear, no clear swelling of tongue was observed, but speech pattern changed, and became less clear over time, after benadryl. Vital Signs: Time: BP: 201/106 P: 86 regular O2 Sats: 100 Labs/tests done: none Medications given: Time: 11:42am Medication: Benadryl i.m. 50 mg in RD. Outcome of the adverse event (if paramedic please list hospital taken to): 10' after benadryl. She reported improvement, however BP remained elevated and voice pattern was still abnormal. Because of the high blood pressure, epi was not provided and ambulance was called. Patient was a hospital patient, and was transported by EMS to Hospital for follow up care. Per ED note- The patient has had resolved symptoms and is in no respiratory distress with stable vital signs. Hypertension has improved. The patient is going to be discharged with primary care physician follow-up. She has been given return precautions for any new or worsening symptoms.
65 2021-02-22 chest discomfort got vac at 12:30 pm 2/20/21, started feeling flue like approx 5:00 pm 2/20/21,sore arm running up my... Read more
got vac at 12:30 pm 2/20/21, started feeling flue like approx 5:00 pm 2/20/21,sore arm running up my neck and shoulders, body aches w/ no thermometer but felt like I had a fever with chills, fatigue, wheezing, head ache that was not constant but hit spuratic from temples to back of head, thought I was feeling better 2/21/21 but symptoms returned and are continuing to current 2/23/21. My current symptoms; I woke up in the night w/loud wheezing continuing through the night and current worse at times when I'm up, some shortness of breath, some cough, some heavy chest feeling, I feel like I have a fever w/chills, fatigue, spuratic headache, cough, some blurred vision w/watery eyes and some crusting. I just feel flue like and want to rest. I have a doctor appt tomorrow 2/24/21 to get checked out. Just wanted to let you know my symptoms. I am healthy and do not take meds of any kind.
65 2021-02-22 chest discomfort Pt. in for a second dose of Covid Vaccine, Moderna, arrived in observation unit with c/o pain in the... Read more
Pt. in for a second dose of Covid Vaccine, Moderna, arrived in observation unit with c/o pain in the spine and tightness in the chest w/o s/s of sob, nausea, vomiting. Pt. states did not have any occurences with the first vaccine. Patient was transported to higher level of care via W/C in no acute distress.
65 2021-02-22 fainting acute flu lasting 3 days followed by 1 day with lighter symptoms. The 3 days included acute pain,f... Read more
acute flu lasting 3 days followed by 1 day with lighter symptoms. The 3 days included acute pain,fatigues,sleepiness,chills, body aches . On day 2 about 28 hours after taking the vaccine I walked to the bathroom and fainted. I am 65 and have never fainted.
65 2021-02-23 blood glucose increased Next Morning after shot i got up the injection site was swollen and real red, itchy burning feeling... Read more
Next Morning after shot i got up the injection site was swollen and real red, itchy burning feeling in it. ache all over and real tired stomach was upset . this morning I woke up with a scratchy throat, sneezing and headache and of and on upset stomach . I have not taken anything for it. only cool rags on it. Blood sugars are running higher than normal.
65 2021-02-23 chest discomfort, palpitations 10:21 Patient complained of mild difficulty breathing, heart racing and slight chest tightness (deni... Read more
10:21 Patient complained of mild difficulty breathing, heart racing and slight chest tightness (denied chest pain - difficulty taking a deep breath) after administration of first dose of Moderna vaccine (Lot # 010A21A, exp. 8/14/21). Vaccine was administered at 9:55am. Denied itching or tightness to throat. BP 180/100 Speaking without difficulty. Hx: asthma and MS; Allergies: morphine - vomiting, hydrocodone, codeine, azithromycin and "other antibiotics" - difficulty breathing, bees - anaphylaxis; patient was observed in clinic x 30 minutes after receiving vaccine due to history of anaphylaxis. 10:22 Physician to assess patient. Patient denied anxiety. No visible edema to face, throat, neck or tongue, lungs CTA. States she has asthma and MS and "feels like this sometimes, but it seems a little worse than normal" BP 182/98. HR 82. Patient had albuterol rescue inhaler with her and took two puffs. 10:30 BP 170/88 HR 80 Pt c/o continued shortness of breath, slightly increased and also c/o mild itching to face underneath mask, but "thinks it might just be her mask". Continues to deny anxiety, but stated inhaler made her jittery and her heart race more. Mask removed. 10:35 Patient developed wheezing upon auscultation, and dyspnea with increased respiration rate worsening itching to face and erythema and edema around mouth. States tightness to chest persists and now feels tightness in her throat. Denies chest pain. Legs elevated. BP 160/80 HR 82 EMS and code blue called. Husband called into clinic from vehicle. 10:36 EPI pen 0.3mg IM right anterolateral thigh administered through pants per Physician. Patient's difficulty breathing improved 30-60 seconds after administration of epinephrine. 10:42 EMS arrived and patient transferred.
65 2021-02-24 chest discomfort chest tightness, tongue swelling, lip tingling
65 2021-02-24 heart rate increased About 10 minutes after injection rapid heartbeat for about 3 minutes then back to normal. Could have... Read more
About 10 minutes after injection rapid heartbeat for about 3 minutes then back to normal. Could have been due to nerves and I did ask my doctor about.
65 2021-02-25 chest discomfort Patient left clinic with husband 15 mins after dose. She noticed she was coughing while she was in t... Read more
Patient left clinic with husband 15 mins after dose. She noticed she was coughing while she was in the obeservation area but thought it was due to wearing a mask. When she got into her car she felt chest tightness and her throat was "gummy", also tingling on lips and mild dizziness/weakness. They returned to the hospital and were escorted to ED to be evaluated. Was given oral benadryl, pepcid, prednisone and albuterol inhaler with effect. Discharged home after 1 hour of observation and symptom resolution.
65 2021-02-25 chest discomfort Developed severe left breast pain had X-rays done thought pneumonia was on antibiotics went back for... Read more
Developed severe left breast pain had X-rays done thought pneumonia was on antibiotics went back for another X-rays it was worse did contrast CTscan fluid on left lung had to have fluid taken out 720cc still no cause and I still have tightness in lung
65 2021-02-25 hypertension Within 5 minutes after vaccination, during the monitoring period the patient experienced a sudden on... Read more
Within 5 minutes after vaccination, during the monitoring period the patient experienced a sudden onset severe headache and sinus pressure. The patient was assessed by on-site EMS, patient was found to be hypertensive. After monitoring, there was no improvement of BP and patient was transported to hospital Emergency Room for further evaluation. Patient stated she was observed at the Emergency Room and her Blood Pressure returned to normal limits.
65 2021-02-25 low blood oxigenation wheezing, SOB, hypoxia into 70s while on her O2. Had to increase O2. Given several nebs, taken to ER
65 2021-02-26 heart rate increased Rapid heart beat; fever; aches; body pains; sore arm. Swollen lymph node in neck by injection site. ... Read more
Rapid heart beat; fever; aches; body pains; sore arm. Swollen lymph node in neck by injection site. Fatigue.
65 2021-02-26 palpitations, fainting Face red Coughing Trouble breathing Nauseous Heart racing Fainted Inability to speak due to thro... Read more
Face red Coughing Trouble breathing Nauseous Heart racing Fainted Inability to speak due to throat swelling up
65 2021-02-28 loss of consciousness 12 hours after injection: Chills lasting several hours with dizziness ~ 20 hours after injection: ... Read more
12 hours after injection: Chills lasting several hours with dizziness ~ 20 hours after injection: Blacked out momentarily, nausea, loss of appetite, fatigue, soreness at injection site and throughout arm and shoulder lasting ~ 24 hours This was the 2nd dose of vaccine after having Covid diagnosis on 12-23-2020, with fairly mild symptoms
65 2021-02-28 palpitations Went to chair- very warm, sweating, clammy. Heart racing. Spoke to nurse- they had no crash box on s... Read more
Went to chair- very warm, sweating, clammy. Heart racing. Spoke to nurse- they had no crash box on site. Nurse had to call 911 to get assistance for me. Nurse told me to take deep breaths, gave me apple juice. Paramedics and ambulance came. Said my heart rate was 120, blood pressure was 166.
65 2021-02-28 fainting, loss of consciousness The morning after receiving Covid-19 vaccination I fainted. I was sitting, working on an i-pad and ... Read more
The morning after receiving Covid-19 vaccination I fainted. I was sitting, working on an i-pad and got up to go to another room. I walked through the house to another room. I noticed my arms and legs felt kind of rubbery and that I didn't seem to have control of them. I fell to the bed and lost consciousness for 5-10 seconds. This was all observed by my spouse. I recovered quickly. The remainder of the day I had a slight headache and felt slightly nauseous. I took acetaminophen before going to bed and woke up the following morning with no complaints .
65 2021-02-28 low platelet count, nosebleed Presents with nosebleed and diffuse petticae. Also has epistaxis and thrombocytopenia. Pateitn repor... Read more
Presents with nosebleed and diffuse petticae. Also has epistaxis and thrombocytopenia. Pateitn reports symptoms for 2 days.
65 2021-03-01 chest pain, fibrin d dimer increased day 1 of vaccine pain swelling redness at the site chills 1-8-21 day 7 continued swelling of L delt... Read more
day 1 of vaccine pain swelling redness at the site chills 1-8-21 day 7 continued swelling of L deltoid size of handball chills continue swelling of lymph nodes in L axilla fatigue 1-28-21 developed strong chest pain substernal to L scapula x 7 hours went to er admitted to hospital elevated d dimer ct of chest nothing acute ekg nothing acute lab work up for evaluation of heart normal continued swollen lymph nodes L axilla swelling of deltoid gone discharge from Hospital after 1 day 2-5-21 had episodes of chest pain relived by rest 4-5 x a day since 1-28-21 unable to work due to chest pain swelling of lymph nodes in L axilla continue fatigue repeated episode of chest pain on 2-5-21 lasting 2 hours went back to hospital monitered for 1 day stress test and echocardiogram normal. 3-2-21 continue to have chest pain with activity ie walk 20-30 ft taking a shower have had chest pain 4-5 x daily since 1-28-21
65 2021-03-01 loss of consciousness Three hours after shot I started getting dizzy. For 4 hours after I was Extremely dizzy, vomited, b... Read more
Three hours after shot I started getting dizzy. For 4 hours after I was Extremely dizzy, vomited, bad shaking chills. It was so sever I wanted to go to ER and be put unconsious. My husband made so many calls for information on help and no one answered until this morning March 2. I didn't feel that I could move to go to ER. I couldn't lay down to stop the spinning it got worse. went to recliner and it wasn't as severe Time went on and I started feelin better. Totally is was a 5 hour trauma for me. FYI
65 2021-03-02 chest discomfort Patient complained of sleeplessness, pressure in chest that subsided, fever of 101.3, aches, pulse 1... Read more
Patient complained of sleeplessness, pressure in chest that subsided, fever of 101.3, aches, pulse 122
65 2021-03-02 chest discomfort Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / ... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
65 2021-03-02 heart rate increased Sudden onset of left arm, neck, back pain, slight headache, rapid heartbeat and body shakes/fever 30... Read more
Sudden onset of left arm, neck, back pain, slight headache, rapid heartbeat and body shakes/fever 30 hours after vaccine was administered
65 2021-03-02 loss of consciousness Adverse reactions occurred 16.5 hours after 2nd shot. High fever (temperature not taken), nausea, vo... Read more
Adverse reactions occurred 16.5 hours after 2nd shot. High fever (temperature not taken), nausea, vomiting, diarrhea, 2 episodes of blacking out, extreme fatigue, muscle aches, headache, no appetite. High fever subsided within about an hour, then lower fever went away in about a day. Nausea, vomiting, and diarrhea limited to one episode each. No further black outs. Fatigue, muscle aches, headache and loss of appetite continued through second day after shot. No pain medications were taken at any time after shot. The 3rd day after the shot, patient was back to normal.
65 2021-03-02 palpitations, heart rate increased Heart palpitations, lasting over 10 hours within 24 hours of injection each time. First dosage caus... Read more
Heart palpitations, lasting over 10 hours within 24 hours of injection each time. First dosage caused an ambulance trip to ER at hospital as it happened twice within 72 hours of injection; once within 24 hours and once 72 hours later. I did not go to hospital after 2nd injection even though my heart rate was over 140 bpm for 10 hours within 24 hours of injection. I had an appointment with a cardiologist, a few days later.
65 2021-03-02 fainting Moderna COVID-19 Vaccine EUA fatigue, aches, weakness, dizziness, fainting, headache mostly the morn... Read more
Moderna COVID-19 Vaccine EUA fatigue, aches, weakness, dizziness, fainting, headache mostly the morning after receiving the shot symptoms gradually subsided during the day
65 2021-03-03 blood pressure increased Patient received her COVID-19 Moderna vaccine this afternoon. She then started "feeling strange" a ... Read more
Patient received her COVID-19 Moderna vaccine this afternoon. She then started "feeling strange" a few minutes later, requesting fresh air. She was monitored outside for 30 minutes. Her O2sat remained >96%ile the entire time. Her HR remained in 60s-70s. Her initial blood pressure was elevated at 210s/140s and improved to 140s/110s with calming relaxation techniques. She did have brief jerking episodes of her lower extremities intermittently. They were suppressible. She remained conscious the entire time and maintained good eye contact. At minute ~20 post-vaccination, she endorsed not remembering why she was there, requesting to stand up. She stood up with support and then sat back down. Repeat BP was elevated to SBP 200s. Decision was made to continue observation in Urgent Care as her blood pressure was still elevated and she still appeared anxious. She was speaking in full sentences and was drinking water without assistance. She was placed into wheelchair and brought to Urgent Care. However, during UC triage, she reportedly informed nursing that she didn't want to be in the enclosed observation room in UC, that she wanted to go home. Her partner wheeled her outside to the patio. When nursing went to go find her, the patient had eloped.
65 2021-03-03 chest discomfort Patient received second Moderna vaccine at 12:15 on Tuesday in her left arm. She started feeling si... Read more
Patient received second Moderna vaccine at 12:15 on Tuesday in her left arm. She started feeling significant symptoms the next morning and went to bed. Her symptoms included headache, nausea, tightness in upper chest, difficultly breathing, achy body, exhausted. Symptoms improved by Thursday at noon, enough to get out of bed. New symptoms on Thursday were painful to touch left side of neck, not able to get comfortable, restless hard to sleeping. On Friday awoke up with swollen neck, enlarged left neck lymph nodes and dizzy. Went to see Employee Health Nurse recommended that patient go home with instructions to follow up Primary PCP on Monday if symptoms don't improve
65 2021-03-03 chest pain 1045-Pt received first dose of Moderna COVID vaccination LOT # 001A21A @ 1045 while in her vehicle. ... Read more
1045-Pt received first dose of Moderna COVID vaccination LOT # 001A21A @ 1045 while in her vehicle. Pt was being observed by EMT. 1055- Pt started feeling short of breath, chest pain, and rash was noted. Called 911 for emergency medical attention. Family notified. Pt was brought into CHD and reported to DON. Pt was flushed, with hives starting on neck and face. 1101-Epi 0.3mg given sq into left arm. EMS arrived and took over care. Flushing, redness, and hives decreasing. Pt loaded onto stretcher and taken to Hospital for further evaluation. Report called to ER . , EMT. Family followed pt and ambulance.
65 2021-03-03 heart rate increased, hypertension Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, ... Read more
Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Additional Details: pt got vaccine at 1115a. complained of fast HR and dizzziness. Was given benadryl. pt vitals were stable upon discharge
65 2021-03-03 heart rate increased Seconds after getting vaccine. I experienced rapid heart rate. And feeling like I was going to faint... Read more
Seconds after getting vaccine. I experienced rapid heart rate. And feeling like I was going to faint. Also both of my hands went extremely cold..
65 2021-03-03 heart rate increased Extreme shaking chills for 2 hours followed by a fever that fluctuated between 102 and 105+ for the ... Read more
Extreme shaking chills for 2 hours followed by a fever that fluctuated between 102 and 105+ for the next 3 hours then went down to 100 to 102 for the next 2-3 hours; heart rate extremely high, usually 72 to 75, resting heart rate has not gone below 80 even as of today, 3 days after the shot...hopefully starting to go back to "normal;" arm where shot was injected still sore after 3 days but starting to feel better.
65 2021-03-05 heart rate abnormal AVG Heart rate while sleeping was 96. And ranged from 40 to 122. Even now it?s over 100
65 2021-03-05 heart rate increased About two hours after the shot I experienced swelling face, eyes and itchy eyes. My heart rate also ... Read more
About two hours after the shot I experienced swelling face, eyes and itchy eyes. My heart rate also steadily increased. Benadryl eased the symptoms in 30 minutes to an hour.
65 2021-03-06 atrial fibrillation Atrial fibrillation event after 27 hours of second Moderna Covid-19 shot; Atrial fibrillation even... Read more
Atrial fibrillation event after 27 hours of second Moderna Covid-19 shot; Atrial fibrillation event after 5 days of first Moderna Covid-19 shot.
65 2021-03-06 chest discomfort Client was in post vaccine waiting area and after 15 minutes post vaccine she reported dizziness and... Read more
Client was in post vaccine waiting area and after 15 minutes post vaccine she reported dizziness and an "uncomfortable feeling" across her chest (does not describe in any more specific terms). VS: HR 73, RR 20, BP 120/80, O2 sat 96%. Client denies any other symptoms and no other changes are noted. Medical information/history was taken, during this time the clients symptoms began to improve. 2:50pm VS: HR 71, RR 20, BP 120/70, O2 sat 97%; client reported symptoms have completely resolved. Assisted client to stand and walk in observation area, gait is steady and client denies any dizziness or return of the "uncomfortable feeling" across her chest. 3:15pm client was assisted to her family vehicle (driven by her daughter) and with the assistance of the translator information was given for the client to seek medical attention if the symptoms return or worsen.
65 2021-03-07 fainting Too ill to function--I had Covid-19 in November, and my response was worse than my worse day of the ... Read more
Too ill to function--I had Covid-19 in November, and my response was worse than my worse day of the two week illness. I was literally green in the face, faint-ish and quite nauseous. I am a healthy person and am quite active. I was in bed unable to do anything for about 12 hours.
65 2021-03-08 blood pressure increased Severe arm pain, fatigue, myalgis. Nausea. Headache. Elevated blood pressure
65 2021-03-08 heart rate increased I received the Moderna COVID-19 first shot vaccination at 11:00am on Thursday, 3/4/21. The next ... Read more
I received the Moderna COVID-19 first shot vaccination at 11:00am on Thursday, 3/4/21. The next day, Friday, 3/5/21, at about 10:00am, I experienced chills and muscle fatigue that lasted until bedtime about 11:00pm. Life returned to normal until yesterday, 3/8/21, when, beginning around 11:00pm and lasting until 11:00pm bedtime, I experience body chills similar to 3/5/21. Today, Tuesday, 3/9/21, when I awoke at 6:00pm, my heart rate was noticeably elevated but stabilized within 15 minutes. And about 10:55am, as I was focusing on work (reviewing/editing an electronic document), I had an unusual blurry vision and mentally spacious experience that lasted for less than 2 minutes but required me to halt work and collect my thoughts. These experiences are completely new to me.
65 2021-03-08 heart rate increased Light headed within minutes, coughing then wheezing, heart rate increased , around lips became itchy... Read more
Light headed within minutes, coughing then wheezing, heart rate increased , around lips became itchy and bumpy. Took my inhaler within 20 minutes better ..6 hours later went into bad bronchitis white frothy thickish sputum lots brought up and cleared airways neededd nebulizer treatments past four days, fatigue, fever highest 100.6, extreme chills next morning and slept a lot of 3/6/2021 and fever. Huge tissue pain, and joint pain worse second day
65 2021-03-09 blood pressure increased Day #1: sore arm and tiredness Day #2: cancer sore on my tongue Day #3: Significant pain in my left... Read more
Day #1: sore arm and tiredness Day #2: cancer sore on my tongue Day #3: Significant pain in my left jaw Significant pain in all of my upper and lower teeth on the left side only The same teeth were super sensitive to cold My left cheek was slightly numb Day #4 (same as Day #3) Day #5 (same as Day #3)
65 2021-03-09 heart rate increased Vaccine #1 - Received first dose of Moderna 1/14/2021 -- Ten-15 minutes after injection began to ha... Read more
Vaccine #1 - Received first dose of Moderna 1/14/2021 -- Ten-15 minutes after injection began to have lips and mouth tingling, wheezing, increase heart rate. Told people at clinic. They said to sit for another 15 minutes and come and get them if it got worse. I went back after ~ 30 minutes total and a couple of medical assistants took my blood pressure. It was 178/158 (normally I run 128/ 68). They asked me to take my inhaler (Advair was all that I had so I took a dose). In addition they gave me one Benadryl tablet (25 mg). 1 hour 20 minutes later my heart rate was 157/124 they gave me another Benadryl to take on my way home if I needed it. *** When I got to my home 30-40 minutes away. I called my internist. I spoke with her nurse and they called back and told me to take my second dose of 25 mg Benadryl. She told me to take 25 to 50 mg of Benadryl one hour before getting my second dose of Moderna vaccine. I had significant swelling on the injection site 3-4 inches in diameters that went down after 5-6/days. Vaccine # 2 - I received my second dose of Moderna 2/19/2021. I took 25mg Benadryl ~ 30 minutes before vaccine and took the additional 25 mg when I returned home. I was extremely cold and could not get warm for 48 hours I took Tylenol. There was no fever. I had wheezing. Swelling day #1 was 1-2 inches Days 2-5 swelling was 4-5.5 inches in diameter. Five to seven days later the swelling and pain resolved.
65 2021-03-09 heart rate increased My arm was throbbing with pain down into my hands. I could hardly lift my arm and could not sleep t... Read more
My arm was throbbing with pain down into my hands. I could hardly lift my arm and could not sleep the first night. I had fever of 100.3, headache, rapid heart beat and joint pain throughout the night. Off and on, I iced my arm for hours. I finally took extra strength tylenol 23 hrs after the injection. It helped but my fever persisted until Tuesday, March 9th along with headache and arm pain. On the evening of March 9, i developed a huge red, warm rash all over my upper arm below the injection site. It is more than half way around my arm and about 3-4 inches long. I rubbed benedryl on it and took a Benedryl pill. It still appears on my arm and is warm and tender on the morning of March 11th.
65 2021-03-09 pulmonary embolism Patient died 2 days after COVID vaccination, concern for vaccine related death. Autopsy showed bila... Read more
Patient died 2 days after COVID vaccination, concern for vaccine related death. Autopsy showed bilateral pulmonary emboli. No evidence death was vaccine related.
65 2021-03-10 blood glucose increased Extreme increase in blood glucose despite pump therapy that adjusts to rises in blood glucose lastin... Read more
Extreme increase in blood glucose despite pump therapy that adjusts to rises in blood glucose lasting for 4 days occurred shortly after vaccine despite not eating. Nausea and diarrhea beginning about 7 hours after vaccine and lasting for 6 days. Extreme burning in bones and pain and some swelling in joints. Feeling of being tired continuing through report date.
65 2021-03-10 heart flutter Heart ?flutters? March 10 around 7 :15 pm. March 11, these continued. Blood Pressure. 156/102. 8... Read more
Heart ?flutters? March 10 around 7 :15 pm. March 11, these continued. Blood Pressure. 156/102. 8:50 am. Took daily meds as listed. Appointment with Cardiologist at 10:45 am. echocardiogram was normal and blood pressure normal. 117/76 at 9:50 am. Flutters continues at home. Rested and drank water.
65 2021-03-11 chest discomfort Received vaccine at 930 am. Within one minute of receiving the vaccine, Patient stated she felt "f... Read more
Received vaccine at 930 am. Within one minute of receiving the vaccine, Patient stated she felt "funny" . She stated she felt her throat was swelling at approx 935. BP 158/70, pulse 76 and regular, respirations 14. 9:39am 5ml Benadryl administered. 9:42 am c/o dizziness, 9:44 c/o chest discomfort and tightness, pain at a "6" and c/o headache, 911 called. Paramedics arrived and transported Patient to hospital. Nurse followed up with Patient the next day. Per Patient, she was transported to the hospital and was monitored in the hospital for several hours and was given Benadryl and prednisone. She was given prescriptions for Benadryl and prednisone at home. Patient stated she feels better, but still has a rash on her body.
65 2021-03-11 heart rate decreased 3"rash around site, chills and fever after 30 minutes of injection, fever for 36 hrs, then hives sta... Read more
3"rash around site, chills and fever after 30 minutes of injection, fever for 36 hrs, then hives started on Monday 3/1, Went to emergency in early evening they gave me intravenous meds and released me 3 hours later. On Tues 3/2/21 about 5:00 pm hives and itching continued and got worst. I went back to emergency and they treated me will pill form medications and released me about 3 hours later. I was still with hives and some itching. On Wed morning 3/3/21 I woke up with severe hives and itching and my face and lips had now blown up and were getting worst. about 3 times the size. We returned to Hospital and the admitted me. I stayed untill Sat morning 3/6/21. I was treated with high doses of steroids, wore a heart monitor because my heart rate dropped to 40 at night.
65 2021-03-11 heart rate increased Chills, body ache, headache, fever, tired, sore arm with this shot and the first Temperature of 100.... Read more
Chills, body ache, headache, fever, tired, sore arm with this shot and the first Temperature of 100.4 treated by self with Tylenol Resting heart rate usually 55-57 but increased to 77-84 End of side effects March 12, 2021 at 7:00
65 2021-03-11 heart rate irregular 5 minutes after shot mouth was numb and severe pain in shot sit, felt a little strange can not des... Read more
5 minutes after shot mouth was numb and severe pain in shot sit, felt a little strange can not describe. Later that day, few hours later leg went numb. That night heart felt strange like it was off beats. Next day same severe pain in arm, leg remains numb, and still feeling issues with heart . Small rash on stomach was full blown with whelps now and coving all of stomach , 4 days later pan in arm gone , small rash on arm gone, Leg still numb it is the right leg and right arm is where I received shot. Heart still bothering e plan to make an appointment to my dr about the heart and whelps on the stomach
65 2021-03-13 heart flutter Minutes after receiving the vaccine, I experienced slight heart flutters for less than a minute and ... Read more
Minutes after receiving the vaccine, I experienced slight heart flutters for less than a minute and slight dizziness also for less than a minute.
65 2021-03-13 chest discomfort Patient received first dose of Moderna vaccine in the left deltoid at 1200. Within one minute post ... Read more
Patient received first dose of Moderna vaccine in the left deltoid at 1200. Within one minute post vaccine administration, patient stated, "I am dizzy and don't feel good." RN called vaccine team lead and clinical operation lead to come assist the patient on a wheelchair and brought her to the observation area to continue monitoring. At 1205 patients BP: 112/78, pulse: 68, O2: 100%, she was given some water to drink and she stated, "I am having a stabbing feeling along my chest". At 1210: EMS was called. At 1213: patient had flushed skin, tongue swelling, and burning sensation was occurring, epi pen was administered on left mid thigh. At 1219: EMS arrived. At 1220: patients vitals: BP: 142/64, pulse: 79, and O2: 100% and stated, "I can swallow now". At 1230: EMS left with patient in stable condition.
65 2021-03-13 heart rate increased At 8:00pm on day of injection started with rash on neck. During night started with fever ranging fro... Read more
At 8:00pm on day of injection started with rash on neck. During night started with fever ranging from 100.6-102 which went on till 7pm following day, Friday the 12th. Woke up Friday morning with face swollen with rash that kept spreading. Was unable to move from bed. Saturday went to urgent care once. I could get out of bed. Elevated heart beat at 100.
65 2021-03-13 loss of consciousness Dizziness, passed out, nausea, severe headache, Body aches, fever of 101.6 on the second day On the... Read more
Dizziness, passed out, nausea, severe headache, Body aches, fever of 101.6 on the second day On the third day fever of 101.1 off and on during the day, body aches, headache and extreme fatigue Fourth day-extreme sore throat, extreme muscus, headache and continued fatigue Fifth day, headache and fatigue , on and off dizziness
65 2021-03-13 fainting Dizziness, shortness of breath, near syncope.
65 2021-03-14 heart rate increased Elevated Heart Rate, BP, followed by vertigo and muscle weakness. Started about 23:30 2/26/21 and l... Read more
Elevated Heart Rate, BP, followed by vertigo and muscle weakness. Started about 23:30 2/26/21 and lasted until 2/27/21 16:00. After that just nausea and tiredness for 3 days.
65 2021-03-14 heart rate increased Rapid heart rate, sweaty, after 10 minutes after injection. Once that stopped pt felt disoriented fo... Read more
Rapid heart rate, sweaty, after 10 minutes after injection. Once that stopped pt felt disoriented for up to 5 hours after. Pt states no sob, no redness, no rash at injection site. Only c/o arm pain after.
65 2021-03-14 pallor, palpitations, palpitations, loss of consciousness, oxygen saturation decreased After chills low grade fever March 8th first night of vaccine, the second day March 9th severe heada... Read more
After chills low grade fever March 8th first night of vaccine, the second day March 9th severe headache neck stiffness/pain, dark urine on waking in am. Heart bounding with some skipped beats. At 12:30 wave of nausea, sat on bathroom floor then awakened outside of bathroom on floor. Got to couch and checked my oxygen saturation with husbands pulse oximeter with no reading showing. My fingers were yellowish and nailbeds pale slightly bluish. I put my husbands oxygen on nasal cannula at 2liters and oxygen saturation came up to 96% and I felt better. Left oxygen on till evening. Drank as much water as I could. March 10th still dehydrated heart rate 100 with some skipped beats and still bounding oxygen saturation 94% room air. Still some nausea. Urine less dark but cloudy. March 11th. Still stiff neck. New left face pain and yellow bruising near left jaw below temple with 2 small blood filled pimple like spots. Better now.
65 2021-03-15 blood pressure increased Mild facial flushing, lip tingling, tightness in forehead within 10 minutes of injection; providers... Read more
Mild facial flushing, lip tingling, tightness in forehead within 10 minutes of injection; providers checked pulse/ox and BP9BP 140/90 which is higher than normal). Symptoms subsided within 25 minutes, but recurred less acutely more than twelve hours later after use of Travaprost eyedrops, then Dorzolamide Timelol drops. Symptoms subsided again within half an hour afterward.
65 2021-03-16 heart rate irregular About 13 hours after receiving the vaccine I experienced excruciating body aches both muscular and s... Read more
About 13 hours after receiving the vaccine I experienced excruciating body aches both muscular and skeletal throughout my body. I have never been in such pain before. I took 2 ibuprofen immediately upon being awakened by the pain. The episode last 2 hours. I also became quite nauseous during the latter part of the 2 hours. I experienced a brief but intense headache during the episode. After that I had intermittent intense pain at sites on my body where I have had injuries in the past year (right shoulder, right foot/ankle, and left elbow tendon. Also, throughout the night I had multiple occurrences of what I deemed extra heart beats. I had extreme dry mouth and periods of feeling hot and cold. FYI, after first shot I had what has been described as "covid arm."
65 2021-03-16 hypertension Received first dose of the Moderna vaccine LOT: #001B21A. Pt flagged down EMT. Pt reported feeling d... Read more
Received first dose of the Moderna vaccine LOT: #001B21A. Pt flagged down EMT. Pt reported feeling dizzy, hypertensive and right arm soreness. BP: 160/96, pulse: 68. EMT offered pt EMS at 1434. Pt refused EMS. Pt stated that she had an allergic reaction to the flu vaccine years ago and that she took her hypertension medication in the morning. Pt stayed an extra 15 minutes for observation. Pt symptoms subsided. Pt left vaccination site at 1447 with a steady gait.
65 2021-03-16 palpitations, heart rate decreased, heart rate increased, oxygen saturation decreased Injection at 1:15 P.M. Awakened at 12:30 A.M. by muscle aches, fever and pounding heart. Checked hea... Read more
Injection at 1:15 P.M. Awakened at 12:30 A.M. by muscle aches, fever and pounding heart. Checked heart rate and is was 130 plus, oxygen saturation level was 91. Tachycardia and low oxygen persisted for several hours, down to 105 bpm by 7:00 A.M. Heart rate dropped to high 90s by approx 10:00 A.M. By 24 hours after injection (approx 1:00 P.M.) high heart rate and low oxygen completely resolved. Please note: no reaction at all to first dose on 2/16/21.
65 2021-03-17 chest discomfort approx. 10 minutes after receiving #2 Moderna vaccine, patient c/o chest tightness and shortness of ... Read more
approx. 10 minutes after receiving #2 Moderna vaccine, patient c/o chest tightness and shortness of breath, after patient's mask was removed and patient took deep breaths she stated she felt better
65 2021-03-17 chest discomfort Approx 6 minutes after administration, pt complained of left arm tingling into hand and fingers, lef... Read more
Approx 6 minutes after administration, pt complained of left arm tingling into hand and fingers, left elbow sharp pains and feeling flushed. As assessing pt, then complained of chest tightness. Denied SOB.
65 2021-03-17 hypertension Dizziness, Headache, HYPERtension, tingling down left arm Narrative: Tingling down left arm Othe... Read more
Dizziness, Headache, HYPERtension, tingling down left arm Narrative: Tingling down left arm Other Relevant History:
65 2021-03-17 loss of consciousness Moderna Fact Sheet reviewed with the client along with V-Safe Information. COVID-19 screening review... Read more
Moderna Fact Sheet reviewed with the client along with V-Safe Information. COVID-19 screening reviewed. Per Report, patient had completed observation after vaccination without problems. She was a passenger in her husband's vehicle- they left the county fairgrounds (Vaccination Site) . Per report, her husband looked over and the client was passes out- he proceeded a measurement of feet down the street and pulled back into the fairground entrance. He immediately requested the staff to call the squad. The patient came around prior to the squad arrival. the staff estimated that the client was potentially " out" for a matter of 3 mins. between leaving observation and returning to the grounds. Our Staff report the client was "out" for approximately 1 min while waiting for the squad to arrive. Client was unconscious per report at time of calling the squad. However prior to the squad arrival the client awoke. Any clinical assessment is unavailable after that. The client and her husband refused treatment from the EMS responders and left the site at will. The client reported a history of "passing out" after receiving vaccines.
65 2021-03-18 cerebrovascular accident Patient called today to report her adverse event. Patient reports several hours after getting her va... Read more
Patient called today to report her adverse event. Patient reports several hours after getting her vaccines being at the ER for stroke like symptoms. Patient reports that after several test were performed they confirmed she had sustained a stroke. Patient was hospitalized for 9 days including rehab.
65 2021-03-18 cerebrovascular accident I had a painful nodule on the left side of my neck, I applied pressure to it and I had complete loss... Read more
I had a painful nodule on the left side of my neck, I applied pressure to it and I had complete loss of sensation and paralysis in my right arm that lasts 5-7 hours. MRI confirmed I had a small stroke. 85% recovered. fatigue and loss of energy.
65 2021-03-18 chest discomfort Painful diarrhea and nausea started within hours of taking the vaccine and has been ongoing for the ... Read more
Painful diarrhea and nausea started within hours of taking the vaccine and has been ongoing for the past 10 days. On 3/14, dizziness and lightheadedness started and continues. Have contacted doctor and went to urgent care. COVID test and Flu test = negative. EKG administered for heaviness in chest. Received medication for dizziness, but no other meds recommended. Misery continues
65 2021-03-18 skin turning blue Progressive: Chills, rigors, temp not to exceed 102 first 36 hours. Rash, lightly cyanotic at inject... Read more
Progressive: Chills, rigors, temp not to exceed 102 first 36 hours. Rash, lightly cyanotic at injection site which continues to progress now with appearance of "blood pressure" cuff nearly circumferential around the upper arm. Good capillary refill, increasing pruritus rather than lessening. Pepcid 20mg BID, Benadryl 25mg q6 hrs and topical steroids not alleviating or lessening the spread of the atypical colored rash.
65 2021-03-18 fast heart rate Bells palsy effect; Rapid heartbeat; Numb nose, nasal cavity, cheeks; Numb eyelids; A spontaneous re... Read more
Bells palsy effect; Rapid heartbeat; Numb nose, nasal cavity, cheeks; Numb eyelids; A spontaneous report was received from a consumer, concerning a 65 year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a rapid heartbeat/tachycardia, her nose, nasal cavity, cheeks and eyelids were numb/hypoaesthesia, Bell's palsy effect/facial paralysis. The patient's medical history included were overweight and pre diabetic. The patient was allergic to latex and was dairy sensitive was not provided. Concomitant product included was vitamins. On 16 Feb2021, few minutes prior to the onset of symptoms, the patient received her first of two planned doses of mRNA-1273 (batch number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient, while she was staying for 15 minutes in the facility, she felt a rapid heartbeat. It was not alarming, but it was faster than normal. Five minutes after leaving the facility, which was 20 minutes after she received the vaccine, her nose, nasal cavity, cheeks and eyelids were numb. This numbness stayed for two hours and the disappeared. The numb sensation on the nose stayed for 3 whole days after the vaccine was administered. The patient consulted the primary doctor, who stated that it was a Bells Palsy effect. Treatment information was not provided. The outcome of the events of rapid heartbeat, nose, nasal cavity, cheeks and eyelids were numb were considered recovered and the outcome for Bells palsy effect was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
65 2021-03-19 pulmonary embolism, deep vein blood clot, low blood platelet count Pt received dose 2 of Moderna COVID19 vaccine on 2/12. Admitted to the hospital 2/24/21 with acute ... Read more
Pt received dose 2 of Moderna COVID19 vaccine on 2/12. Admitted to the hospital 2/24/21 with acute ITP. Subsequently admitted 3/19 with extensive bilateral LE DVTs and pulmonary embolism.
65 2021-03-21 lightheadedness, very slow heart rate, pallor Called over to patient by observer. Patient c/o feeling near syncope. She was pale, diaphoretic, and... Read more
Called over to patient by observer. Patient c/o feeling near syncope. She was pale, diaphoretic, and bradycardic to 58. Patient reports history of previous near syncope/syncopal events with blood draw and immunizations. She reports no adverse reaction to the first dose.
65 2021-03-21 fainting pt states that 11 hours after taking the 2nd dose she collapsed falling to the floor and was paralyz... Read more
pt states that 11 hours after taking the 2nd dose she collapsed falling to the floor and was paralyzed and had urinary incontinence for 20 hours. EMT came to put pt back in bed. EMT came once again and put pt in wheelchair to get her to a car so she can be taken to Hospital ER. They did blood work which potassium was low, urinalysis test showed bladder infection, and CT was normal. Pt released after 4 hours and told to FU w/ her neurologist. Pt saw Neuro Dr. on 3/17/2021 said she must have had some sort of reaction to the vaccine.
65 2021-03-21 transient ischaemic attack On March 13, I developed double vision, dizziness and nystagmus. I was transferred by ambulance to ... Read more
On March 13, I developed double vision, dizziness and nystagmus. I was transferred by ambulance to a hospital due to stroke symptoms. Admitted overnight. Diagnosis: Transient Ischemic Attack. This occurred one month after second Covid injection.
65 2021-03-22 arrhythmia, chest pain, palpitations Severe itching for 3-1/2 weeks up to current date of 3/22/2012 (off and on) Occasional whole body tr... Read more
Severe itching for 3-1/2 weeks up to current date of 3/22/2012 (off and on) Occasional whole body tremors Flu-like feeling Fatigue Heart arrhythmia, palpitations and chest pain Off balance occasionally
65 2021-03-22 cardiac arrest Sudden onset of shortness of breath early morning 3/15/2021. EMS called, transported patient to Adve... Read more
Sudden onset of shortness of breath early morning 3/15/2021. EMS called, transported patient to Adventist to ER code blue in asystole. Asystole on arrival, no response to resuscitative efforts, pronounced dead in ER.
65 2021-03-23 chest pain, arrhythmia Flue like symptoms; Little off balance; Severe mid chest pain; Fatigue; Arrhythmia a couple of times... Read more
Flue like symptoms; Little off balance; Severe mid chest pain; Fatigue; Arrhythmia a couple of times; Tremors a couple of times; Itching all over the body; A spontaneous report was received from a consumer concerning a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itching all over the body/pruritus, fatigue, flue like symptoms/influenza like illness, little off balance/balance disorder, tremors and arrhythmia(intervention/medically important) a couple of times and severe mid chest pain/ chest pain. The patient's medical history as provided by the reporter included cochlear implant. Concomitant medications reported included domperidone. On 09 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 12 Feb 2021, the patient experienced itching all over the body. On an unspecified date, the patient experienced fatigue, flue like symptoms, little off balance, tremors and arrhythmia a couple of times and severe mid chest pain. Lab details were not provided by the reporter. Treatment for the events included ibuprofen. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events, itching all over the body, fatigue, flue like symptoms, little off balance, tremors and arrhythmia a couple of times and severe mid chest pain were unknown.; Reporter's Comments: events of unexpected influenza-like illness, chest pain, tremor, balance disorder, pruritus, and expected fatigue. Event onset occurred Day 4 after the first dose of mRNA-1273. Treatment with ibuprofen. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
65 2021-03-23 chest pain, chest discomfort Full Body Rash with blisters and hives. Rash is hot and itchy. Makes the body feel anxious in the ch... Read more
Full Body Rash with blisters and hives. Rash is hot and itchy. Makes the body feel anxious in the chest area. Weakness, slight head fog, and heartburn. Went to the Emergency room. Was given Antacid. I had already taken Benadryl. Topical application is Benadryl and hydrocortisone. No relief. Day 2 Used EMU oil on rash and it gave relief but rash came back after 7 hours. Plus vomiting of food and antihistamines. Day 3 Using EMU oil, Benadryl topical and orally. Rash is not as severe but the burning in the limbs, hands and feet still present but not as visible. Pain in abdomen, and chest, but no vomiting. Stopped taking the acid reducer only the Benadryl. Omega vitamins with vitamin D seemed to help stop the burning under the skin on Day 2 but not Day 3 Throat is raspy and voice has a different sound; lower and breaking up. Sleeping a lot
65 2021-03-23 hypertension 3/5 painful cyst inside left nostril 3/6 painful swelling under & on sides of tongue 3/7 painful bli... Read more
3/5 painful cyst inside left nostril 3/6 painful swelling under & on sides of tongue 3/7 painful blisters started to form on tongue 3/8 painful blisters started forming on inside of lower lip 3/9 lip started to swell up to the point of interfering with my speech 3/10 chin started to swell up so I went to Urgent Care. They injected me with Benedryl & Toradol. I felt better but when I woke up the next morning, I was worse. 3/11 painful hard lump in chin was growing larger & pain was moving up the left side of my face toward my ear, so I went to the ER. Doctor did CT scan and blood work. CT showed inflammation in my chin. Blood work showed high white blood cells. I think they were eosinophils. Prescribed Keflex & sent me home.
65 2021-03-25 fainting Chills, fatigue, fainting. Cut head during fainting episode on 3/26 which required urgent care to... Read more
Chills, fatigue, fainting. Cut head during fainting episode on 3/26 which required urgent care to close the wound with stapes.
65 2021-03-26 cerebrovascular accident Stroke Medication to thin my blood Good recovery
65 2021-03-26 chest discomfort Pt complains of chest pressure and inability to take a deep breath with a feeling of flushing with t... Read more
Pt complains of chest pressure and inability to take a deep breath with a feeling of flushing with the vaccine
65 2021-03-27 heart rate increased, increased heart rate, blood pressure increased After 5 minutes, had the 'taste' of silver in mouth, then heart rate started going up - at HR 126 be... Read more
After 5 minutes, had the 'taste' of silver in mouth, then heart rate started going up - at HR 126 beats, I called over to nurse monitor. She took my blood pressure, it was 195/90 with 126 HR. I normally have normal blood pressure. Doctor also came over. After 30 minutes, still elevated BP & HR. Told me to go to ER. Was at ER for 4 hours. EKG was ok, sinus tachycardia. Blood pressure eventually went to 154/80, HR stayed over 100. Given 1 1/2 IV fluids. Discharged, HR slowly came down. BP okay the next day.
65 2021-03-27 heart rate increased About 4 hours after the vaccine, I had a rapid heart rate for over 24 hours. I stayed in bed and di... Read more
About 4 hours after the vaccine, I had a rapid heart rate for over 24 hours. I stayed in bed and didn't do any physical activity. I am worried about taking the 2nd dose of vaccine.
65 2021-03-27 loss of consciousness Had vaccine. Went Home; was okay until that evening. Had slight headache, tired achy so took 1 ty... Read more
Had vaccine. Went Home; was okay until that evening. Had slight headache, tired achy so took 1 tylenol pm and went to bed. Woke up to to go bathroom and felt nauseous and light headed. Went to bathroom was washing hands and room was spinning. Called for my husband and he came to help hold me but a passed out, slipped out of his arms and landed on floor. I came to, he took my oxygen which was 77; fever of 100. He put my oxygen on and got me to bed. Woke up next morning, nauseous all day, headache, and have a black eye from fall. Felt tired but felt better the following day.
65 2021-03-27 fainting Fainted. Felt faint, sat in chair, fainted, woke up on floor with chair tipped over. Nauseated, diz... Read more
Fainted. Felt faint, sat in chair, fainted, woke up on floor with chair tipped over. Nauseated, dizzy, & stiff muscles for several hours.
65 2021-03-28 loss of consciousness Wooziness Passing out Vomiting Fever Body Aches
65 2021-03-29 chest discomfort INITIALLY COMPLAINED OF HEAD HURTING A LITTLE AND SLIGHTLY DIZZY. 5 MINUTES LATER COMPLAINED OF THR... Read more
INITIALLY COMPLAINED OF HEAD HURTING A LITTLE AND SLIGHTLY DIZZY. 5 MINUTES LATER COMPLAINED OF THROAT AND CHEST FEELING TIGHT AND DIFFICULTY BREATHING. DOSED WITH EPI AUTO INJECTOR X 2 AND BENADRYL IM 100 MG AND SHE WAS TRANSPORTED TO ER FOR EVALUATION.
65 2021-03-30 hypotension, palpitations 2/16 vaccination Rash on arm of injection. Took antihistamine. Spoke with allergist and cardiologist... Read more
2/16 vaccination Rash on arm of injection. Took antihistamine. Spoke with allergist and cardiologist; family hx of afib. Told me to take medication for palpitations but I chose not to because my BP tends to run low
65 2021-03-30 loss of consciousness, blood glucose increased Passed out and had to go to emergency. My glucose level went high and my phrospherose and potassium ... Read more
Passed out and had to go to emergency. My glucose level went high and my phrospherose and potassium level was very low
65 2021-03-30 loss of consciousness passed out on the floor; heaving all day; really cold; headache; fever; chills; A spontaneous report... Read more
passed out on the floor; heaving all day; really cold; headache; fever; chills; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out on the floor, really cold, heaving all day, headache, fever and chills. The patient's medical history was not provided. No relevant concomitant medications were reported. On 21 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot: 007M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 21 Feb 2021, patient experienced sore arm and it recovered on 22 Feb 2021. On 18 Mar 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch:032M20A) through unknown route of administration in the left deltoid muscle for prophylaxis of COVID-19 infection. On 18 Mar 2021, the patient experienced really cold, headache, fever and chills. On 19 Mar 2021, the patient experienced passed out on the floor and heaving all day. The event passed out was medically significant. No laboratory data was provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable as it was second dose of vaccine. Th events really cold, fever and chills were recovered on 19 Mar 2021. On 19 Mar 2021 the outcome of cold, fever and chills. On 20 Mar 2021 the outcome of event(s), headache, passed out on the floor, heaving all day was resolved..; Reporter's Comments: This case concerns a 65 Y/O F with serious unexpected loss of consciousness and nonserious unexpected retching and nasopharyngitis, and expected pyrexia, chills, and headache. Event onset the same day as the second dose of mRNA-1273. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
65 2021-03-30 palpitations 5 min post vaccination weird metallic taste in mouth and severe flushing/heat felt, some heart racin... Read more
5 min post vaccination weird metallic taste in mouth and severe flushing/heat felt, some heart racing, lasted 2 min. 24 hours later developed fever, severe chills, severe fatigue, heart racing, general malaise. All of these symptoms improved and gone within 24 hours.
65 2021-03-30 palpitations Both of my vaccination, within 10 minutes, I felt like a wave came over me, flushed and palpitations... Read more
Both of my vaccination, within 10 minutes, I felt like a wave came over me, flushed and palpitations. They monitored me for an hour. I did get the rash on arm, was not as extensive as the first vaccine. I took antihistamines. I was in bed for 1 day; fatigue. Next day I was fine. Telehealth with allergist and cardiologist; family hx of afib. Told me to take medication for palpitations but I chose not to because my BP tends to run low.
65 2021-03-31 blood pressure increased blood pressure high; swelling right hand; severe numbness on right hand,severe numbness on left hand... Read more
blood pressure high; swelling right hand; severe numbness on right hand,severe numbness on left hand; delayed hypersensitivity reaction; Hypersensitivity reaction; Body rash,rash over arms,rash over foots; rash progressed into large red patches; rash large and red patches over wrists; tingle right hand/like electric shooting on hands; A spontaneous report was received from a Healthcare Professional who is also a Consumer and a 65-years-old male patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced elevated blood pressure, hypoesthesia , peripheral swelling , paresthesia, erythema, rash erythematous, rash, and delayed hypersensitivity . The patient's medical history was not provided but she reported she does not suffer of chronic hypertension. Concomitant medications reported were cholesterol medicine (Lipitor), levothyroxine, calcium, vitamin D, multivitamin, magnesium for drug use for unknown indication. On 24-JAN-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 02-FEB-2021, the patient experienced a delayed hypersensitivity reaction with body rash, rash over arms, rash over foots, rash over hips, rash over chest, rash very itchy, rash progressed into large red patches, large and red rash patches over wrists, tingling right hand, swelling right hand, severe numbness on right hand, severe numbness on left hand, like electric shooting on hands. On 04-FEB-2021, the patient experienced the blood pressure high without being hypertensive before. From 04-FEB-2021 to 05-FEB-2021, treatment included Benadryl and Oral Prednisone, which solved the rash. Additiona treatment was reported to start on 11-FEB-2021 and included Oral Prednisone and Gabapentin.. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events elevated blood pressure, hypoesthesia , peripheral swelling , paresthesia, erythema, rash erythematous, rash, and delayed hypersensitivity was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
65 2021-03-31 fibrin d dimer increased About 3 days after the vaccine my daughter mentioned to me that I was not breathing right. It was ha... Read more
About 3 days after the vaccine my daughter mentioned to me that I was not breathing right. It was harder to breathe and I could not even take a shower that I would be out of breath. My daughter checked my pulsox and it was 85. I couldn't really walk or do anything so my daughter transported me to ER and lots of labs were done so since my D Dimer was too high they did a CT scan and it showed some blood clots in my lungs. They admitted me because they were concerned with the location of one of them. They did some heart tests too and put me on Eloquis and then sent me home. I stayed for 2 days. Then they scheduled me FUs with a heart doctor and a pulmonologist.
65 2021-03-31 heart rate increased F,ever, chills, headaches, fatigue, dizzy, rapid, heartbeat, body aches, pain at site of injection, ... Read more
F,ever, chills, headaches, fatigue, dizzy, rapid, heartbeat, body aches, pain at site of injection, on set of symptoms 8 hours, has continued over 32 hours to current 9AM April 1st, 2021
65 2021-03-31 loss of consciousness Passed out; Foggy; Dull headache; Achy; Very tired; Nausea; A spontaneous report was received from a... Read more
Passed out; Foggy; Dull headache; Achy; Very tired; Nausea; A spontaneous report was received from a consumer concerning a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced foggy, passed out, dull headache, achy, very tired, nausea. The patient's medical history was not provided. Concomitant medications reported included insulin, pravastatin, enalapril maleate. On an unspecified date, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route and site for prophylaxis of COVID-19 infection. On 11 Mar 2021, approximately 7 hours prior to the event, the patient received her second dose of mRNA-1273 (Lot number: unknown) intramuscular in right arm deltoid for prophylaxis of COVID-19 infection On 11 Mar 2021, the patient experienced foggy, passed out, dull headache, achy, very tired, nausea. . Treatment for the events included paracetamol. Action taken with mRNA-1273 in response to the events is not applicable. The events, dull headache, achy, foggy, passed out, very tired, nausea were considered recovered after week and half.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
65 2021-03-31 palpitations, chest discomfort at 10:33 chest feeling full like could stop breathing any second along with a weird headache, then d... Read more
at 10:33 chest feeling full like could stop breathing any second along with a weird headache, then dizzy head through chest, down arms, legs and toes. at 10:40 Hard pain started in a wide band from right side of back and went to left . at 11:10 Tongue and tip of tongue went numb and metal taste. then upper lip went numb. 11:20 Outer upper mouth numb and still weird taste, but now strange smell. 11:29 Nose now numb and upper chest feels icy cold and numb inside. 11:36 Now cheeks numb and chin. Still weird feeling in chest and down arms. some nausea now. 12:31 Really bad left eye pain for about 10 seconds. 1:30 Now only tongue and upper lip still numb. 1:35 heart pounding in chest and head . pounding stopped at 1:55. At 2:15 All stared going away, face turned bright red with heat. at 4:00 still have left eye pain and headache, other all gone
65 2021-03-31 palpitations Patient reports heart palpitations starting immediately after the vaccine was administered and laste... Read more
Patient reports heart palpitations starting immediately after the vaccine was administered and lasted 2 to 2 1/2 hours. She also reports breathing problems but is unsure if it is related to her asthma. Patient reports no chest pains.
65 2021-04-01 palpitations Basic Information Chief Complaint Palpitations began at 0940 today, Hx SVT, received second dose ... Read more
Basic Information Chief Complaint Palpitations began at 0940 today, Hx SVT, received second dose of Moderna vaccine yesterday History of Present Illness 65F with hypothyroidism and hx of SVT, who presents with palpitations. She has had palpitations reportedly since childhood and has documented SVT on cardiac monitor in 3/2017. At baseline she has palpitations 1-4x per month, but she has had more frequent palpitations since receiving the COVID vaccine earlier this month. 2nd COVID dose yesterday. Today her palpitaitons lasted 1.5 hours prompting her to present to ED. She is asymptomatic aside from palpitations. No lightheadedness, syncope, chest pain, SOB, N/V, diaphoresis. No leg swelling. She is able to walk around while having palpitations. She does not take rate control agents or anticoagulation. She has plans to see her ARNP for outpatient cardiac monitoring in mid April.
65 2021-04-01 fainting fever 102.5 degrees (Sat 3/27); fever 100 (Sun 3/28); temperature dropped into 96-96.6 range (Tues )... Read more
fever 102.5 degrees (Sat 3/27); fever 100 (Sun 3/28); temperature dropped into 96-96.6 range (Tues ) and I felt weak/shaky/faint; extreme fatigue (4 days); weakness (4 days); body aches (2 days); joint aches (right shoulder; left hand); "Covid arm" - pain; hard lump; rash in circular pattern around injection side (lasted 4 days); high blood pressure (145/90; no previous history) - ongoing; fatigue and lack of energy (ongoing)
65 2021-04-02 fainting Fainted
65 2021-04-03 arrhythmia Aproximately 1 day after vaccine, I felt shortness of breath. Symptoms increased over the next few ... Read more
Aproximately 1 day after vaccine, I felt shortness of breath. Symptoms increased over the next few days. Arrythmia grew worse to the point I felt I might faint. Visited ER. EKG showed Mobitz Type 1 Heart Block and Dr. suspected A-Fib though it wasn't appearing on EKG. (Previous history of A-Fib, but ended treatment approximately 2010 because of long term lack of symptoms and normal EKG, Echo.) I have been nonsymptomatic for at least 20 years.. Symptoms continued through 3/15/3031 though decreasing each day.
65 2021-04-03 blood pressure increased Blood pressure was 200/100; Very dizzy; Could not lie down without things spinning around; Felt unst... Read more
Blood pressure was 200/100; Very dizzy; Could not lie down without things spinning around; Felt unsteady; Nauseous; A spontaneous report was received from a consumer concerning a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood pressure raise (200/100) with dizziness, nausea, vertigo and gait disturbance. The patient's medical history was not provided. Concomitant medications were not reported. On 27 Feb 2021, 16 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 010A21A) intramuscularly for the prophylaxis of COVID-19 infection. On 28 Feb 2021, the patient woke up to turn over and was very dizzy. The dizziness continue most of the following day, and the patient was also nauseous and could not lie down without things spinning around. The patient stayed upright and felt unsteady so they had to hold on to the walls to move around. The patient was taken to urgent care where her blood pressure was 200/100. She was taken to the hospital where she remained for two days and tests were taken. Treatment medications included nitroglycerin and acetylsalicylic acid. The patient was released from the hospital on 02 Mar 2021. She had an appointment with her PCP (primary care physician) on Friday 05 Mar 2021 for follow-up. Action taken with mRNA-1273 in response to the events was unknown. The outcomes of the events were reported as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
65 2021-04-03 loss of consciousness I sat down on floor passed out for 5 mins; light headedness, dizzy; Sweaty; arm soreness; legs felt ... Read more
I sat down on floor passed out for 5 mins; light headedness, dizzy; Sweaty; arm soreness; legs felt achy; A spontaneous report was received from a consumer who was also a 65-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sat down on floor passed out for 5 mins/ loss of consciousness, legs felt achy/ pain in extremity, light headedness, dizzy/ dizziness, sweaty/hyperhidrosis, and arm soreness/ vaccination site pain. The patient's medical history was not provided. Concomitant medications included fluticasone propionate and salmeterol xinafoate and salbutamol. On 27 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 28 Feb 2021, the patient had arm soreness and in night her legs felt achy. On 01 Mar 2021, the patient suddenly had light headedness, dizzy, and sweaty. The patient sat down on floor passed out for five minutes. The patient reported feeling better. Treatment for the events included Ibuprofen and paracetamol. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, the patient sat down on floor passed out for five minutes was considered as resolved on 1 Mar 2021. The outcome of the events, the patient suddenly had light headedness, dizzy, and sweaty was considered recovering.; Reporter's Comments: This case concerns a 65-year-old female with serious unexpected events of loss of consciousness along with nonserious unexpected dizziness, hyperhidrosis, pain in extremity and expected vaccination site pain. Event onset occurred 2 days after the first dose of mRNA-1273. Treatment included Motrin and Tylenol. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
65 2021-04-03 loss of consciousness Woke up feeling very full. Didn?t feel good when standing. Sat down and continued to feel bad. Stood... Read more
Woke up feeling very full. Didn?t feel good when standing. Sat down and continued to feel bad. Stood up and started to walk to restroom and passed out. Was not unconscious as I was aware of family responses. Put a cold wash rag to forehead. Within a few minutes I felt fine.
65 2021-04-05 arrhythmia, fast heart rate Swelling and soreness in arm. Rash, extreme itchiness, chills, sweating, coldness, tingling and swel... Read more
Swelling and soreness in arm. Rash, extreme itchiness, chills, sweating, coldness, tingling and swelling in neck, tingling and burning, stinging in torso and arms, confusion still occurring 25 days later. Arythymia/tacardia may be normal due to temporarily stopping medication.
65 2021-04-05 blood pressure increased I was fine until 9 days later. My arm was extremely painful, very swollen and hot to the touch. The ... Read more
I was fine until 9 days later. My arm was extremely painful, very swollen and hot to the touch. The doctor gave me an injection of antibiotics and prescription of pills as well. It started going down that night, but by the next day it had gone down quite a bit. I was referred to an allergist and after looking at the photos, she said I was probably had too many histamines and need antihistamines instead antibiotics. I told her I was worried about the 2nd dose, so she told me to take Claritin the day before and continue on it for 10 days. After the 2nd dose, I had the same arm issues, along with an unusual feeling in my head. My BP was higher than it's ever been at 184/88. About
65 2021-04-05 cardiac arrest cardiac arrest; This spontaneous case was reported by a consumer and describes the occurrence of CAR... Read more
cardiac arrest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (cardiac arrest) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011A21A) for COVID-19 vaccination. The patient's past medical history included Heart attack in September 2020. Concomitant products included LEVOTHYROXINE, ATORVASTATIN, CLOPIDOGREL BISULFATE (PLAVIX), CARVEDILOL, ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D3, ALENDRONATE SODIUM (ALENDRONATE), LISINOPRIL and FAMOTIDINE for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criterion hospitalization). The patient was hospitalized on 27-Mar-2021 due to CARDIAC ARREST. At the time of the report, CARDIAC ARREST (cardiac arrest) outcome was unknown. Cardiac catheterization to be performed on the patient on 31-MAR-2021. Based on the current available information and temporal association between the use of the product and the onset date of the reported event of cardiac arrest, a causal relationship cannot be excluded. However, patient's recent myocardial infarction may have been contributory.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of cardiac arrest, a causal relationship cannot be excluded. However, patient's recent myocardial infarction may have been contributory.
65 2021-04-05 low blood oxigenation Moderna COVID Vaccine EUA Pt received Dose 1 of Moderna vaccine 3/18/21. Developed symptoms 3/25/21... Read more
Moderna COVID Vaccine EUA Pt received Dose 1 of Moderna vaccine 3/18/21. Developed symptoms 3/25/21. Presented to ED 3/28/21. 3/28/21: 65-year-old female with past medical history of hypertension, hyperlipidemia, and type 2 diabetes mellitus presented to ER with complaints of shortness of breath. Per patient she received her 1st COVID-19 vaccination last Thursday. Since Monday the patient has felt "unwell." Three days ago she started having shortness of breath which has progressively worsened, especially with exertion. She has developed increased fatigue, cough, nausea and decreased appetite. Denies chest pain. No vomiting or diarrhea. On arrival to ED patient she had a low-grade fever and was hypoxic at 87% on room air. Supplemental oxygen with 2 L NC with improvement in oxygenation saturation to 94%. Laboratory findings were significant for hypokalemia 3.0, transaminitis ALT 55, AST 44. COVID positive. Chest x-ray revealed bilateral airspace disease with obscured pulmonary vasculature. Favored to represent pneumonia over heart failure. EKG normal sinus rhythm, rate 74, QTC 472. Patient was given IV fluid resuscitation with NS 3 L bolus. Potassium 60 mEq p.o. given. IV Rocephin was initiated and DuoNeb treatment given in ER. 4/2/21: Pt received remdesivir, convalescent plasma, ceftriaxone, doxycycline, dexamethasone, vitamin C, zinc sulfate. Patient discharged on doxycycline course, PO zinc and vitamin C, supplemental oxygen. Instructed to follow up with PCP in 3-5 days.
65 2021-04-05 loss of consciousness She got her vaccine, and started out with the sore arm, but she was sitting in the bathroom sometime... Read more
She got her vaccine, and started out with the sore arm, but she was sitting in the bathroom sometime after 11:00 preparing to do a peritoneal dialysis exchange and blacked out. She grabbed onto the towel bar on the wall and fell hitting her left hip, left ankle and left upper arm. She does not remember too much after that, but that she was in and out of consciousness until about 12:30 PM Saturday when she remembered being alert but nothing made any sense to her. Her son came in and found her on the floor, she could not get up, she had a skin tear on her right elbow and she had been incontinent of bowel and bladder. He started to ask her the orientation questions and got them all wrong, but she knew that she was confused and disoriented. She could not get up on her own, called the paramedics and they took her to the hospital. The confusion and disorientation lasted into early Sunday morning 3/28/2021 at about 3:00 AM when she started to answer questions appropriately. As the day went on things got better, but still exist to this point today 4/6/21. It was more severe as she came out of the confusion. She has brain fog, inability to sequence thoughts, a little bit of expressive aphasia. She had two CAT scans and an MRI that were negative for subdural or CVA's. I had urine specimen and blood cultures to rule out a UTI or sepsis and those were negative. Her kidney labs were normal. She ABG's drawn and those were normal. They placed her on oxygen and she sat for 3 days and then they released her to home. Today, she is still having the brain fog, still the not able to sequence thoughts, general fatigue. She is black and blue from shoulder to elbow due to the fall.
65 2021-04-05 fainting April 2, 2021 - 11:30am - soreness of arm - small round red at injection site April 3, 20... Read more
April 2, 2021 - 11:30am - soreness of arm - small round red at injection site April 3, 2021 - 3:30am. - woke with chills, shivering, fever of 102.5, shortness of breath - took Advil - did breathing exercises arm soreness continues, headache, fever throughout the day (100 to 101.5), trouble focusing, nausea, 2:00pm - chills and shivering April 4, 2021. - fever continues (99 to 101), nausea, trouble focusing, headache, Tylenol and Advil, arm very sore, swollen, redness growing to size of orange. Ice pack to arm April 5, 2021 - feeling extremely faint and nausea, lay down and faintness goes away in about 30 minutes, diarrhea. Ice pack to arm. Fever under 100. Arm redness is now softball size, hot, swollen and red blotchy patches beginning below the main area and going around to the back of arm.
65 2021-04-06 chest discomfort Patient reported back approximately 20 minutes after vaccination with itching on forehead/arms and w... Read more
Patient reported back approximately 20 minutes after vaccination with itching on forehead/arms and whelps on neck. Patient was given diphenhydramine 50mg orally, EMS was contacted. Patient began to have heaviness in chest, therefore EMS transported her to hospital for observation and treatment.
65 2021-04-06 pulmonary embolism, blood pressure increased, chest pain 02/23/21, 7 pm - upset stomach and sore arm at injection site 02/24/21, 7 am to 11 pm - upset stomac... Read more
02/23/21, 7 pm - upset stomach and sore arm at injection site 02/24/21, 7 am to 11 pm - upset stomach, headache, body aches & chills and sore arm at injection site 02/25/21, 7 am to 02/27/21, 7 am - sore and swollen left underarm and breast, itchy rash extending down upper arm from injection site 02/27/21, 7 am to 02/28/21, 11 pm - swelling of left knee and left ankle 03/03/21, 7am to 03/06/21, 10 pm - back pain along bottom of right shoulder blade 03/08/21, 8 pm to 03/18/21, 10 pm - chest pain under right breast, especially with deep breathing, and highly elevated blood pressure
65 2021-04-06 fainting, platelet count decreased Woke up from sleeping in the middle of the night to go to the bathroom, fainted on floor. Woke up o... Read more
Woke up from sleeping in the middle of the night to go to the bathroom, fainted on floor. Woke up on bathroom floor. Not sure how long I was there. Couldn't get up was sweating, nauseas and had the chills. Crawled back to bed. Slept another 8-10 hours. Woke up at 2PM. Wanted to see if I had a concussion given I'd fallen on a tile floor. Was seen at Sollis Health they discovered I was likely dehydrated so they gave me an IV to hydrate and my platelets were very low (they're usually normal). Was tired, chills, nausea, weak and slept a ton until Sunday when I woke up feeling fine. Had platelets checked later that week and they were fine. After first shot got "covid arm" on day 10. Arm still hurts in the area, thought less than it did after the second dose.
65 2021-04-06 fast heart rate, palpitations In the evening of Day 1, the patient experienced tachycardia which she described as heart racing. I... Read more
In the evening of Day 1, the patient experienced tachycardia which she described as heart racing. In the afternoon of day 2, she experienced a brief episode of blurred vision and a sharp shooting pain in her arm that lasted about 2 minutes. Later that evening she began to experience severe chills and a fever of 101.6. She was also awakened in the middle of the night by a shooting pain that originated in her left leg and radiated to her back and then back down again. She also developed a 4 inch red rash on her left arm, noticeable swelling (2 inch) around the injection site, and shooting pain from the shoulder, through the elbow and down to the wrist. Additional rashes developed on the inner arm near the elbow and two patches developed on her neck. The neck rashes became dry the next day and she experiencing skin peeling and she still has residual redness with these rashes. She is still experiencing mild pain in her left arm and weakness with her wrist and upper hand that makes it difficult to lift anything with her left hand.
65 2021-04-07 low blood oxigenation, pulmonary embolism, oxygen saturation decreased, chest pain Vaccine breakthrough hospitalization - SOB with O2 sat 50% when EMS arrived. On non-rebreather satti... Read more
Vaccine breakthrough hospitalization - SOB with O2 sat 50% when EMS arrived. On non-rebreather satting 70%. Chills, fever, cough, and chest pain. BP 152/79, HR 93, RR 20, SpO2 91%. Had been scheduled to receive COVID mAb day of admission, but clinical course worsened. Admitted to Medical ICU for acute respiratory failure with hypoxia and ARDS secondary to COVID-19. Placed on BIPAP and Rx with Remdesivir, dexamethasone, & tociluzumab. Treated for presumed pulmonary embolism with full-dose anticoagulation. Pt expressed wishes to remain DNR/DNI, ultimately she elected to transition to comfort measures only given worsening hypoxia.
65 2021-04-07 inflammation of the pericardium Acid Reflux, headache, pericarditis, abdominal pain, upper and lower abdomen, fatigue, nausea
65 2021-04-07 pulmonary embolism On 3/4/2021 I was diagnosed with metastatic lung cancer which further studies showed that there were... Read more
On 3/4/2021 I was diagnosed with metastatic lung cancer which further studies showed that there were innumerable bone and organ metastases. On 3/12/2021 I was further diagnosed with multiple pulmonary emboli.
65 2021-04-08 chest discomfort Had shot 4/7/21 at 2:30pm. Started getting aches and pains about 6:30pm the next day. The 2nd day af... Read more
Had shot 4/7/21 at 2:30pm. Started getting aches and pains about 6:30pm the next day. The 2nd day after I have been experiencing weakness, dense feeling in my chest, breathing shallower, some upset stomach for a short time, ears ringing, woozyness. Had virtual appointment with P.A. and described how I felt.
65 2021-04-08 loss of consciousness 1158: Vaccination given 1215: c/o dizziness, transferred to recliner. Passed out in recliner, air... Read more
1158: Vaccination given 1215: c/o dizziness, transferred to recliner. Passed out in recliner, airway protected. RR 12 1220: able to arouse; feels dizzy 1222: BP: 127/58. HR 62. SpO2% 97. Itchy, can barely speak, difficult to arouse. Epinephrine 0.3 mg IM in Right quad. 1225: BP: 126/58. HR 60. SpO2 100 %. no signs of angioedema: breathing without difficulty; speech more clear; follows commands. Drank water without signs or symptoms of dysphagia. States normal HR 80-100. 1235: BP: 123/83. HR 59. SpO2 100%. awake and alert; will continue to observe. DC at 1300 if stable. Advised to notify PCP of reaction to determine if 2nd dose advised. 1256: BP 117/64. HR 61. SpO2 98%. Awake and alert. Ready to leave in care of husband. 1743: Called and checked on patient. Patient doing well.
65 2021-04-08 heart attack, cardiac failure congestive Dose 1 - Fever 104.1 degrees, severe chills, dizziness, temporary loss of bladder control (12 hrs. d... Read more
Dose 1 - Fever 104.1 degrees, severe chills, dizziness, temporary loss of bladder control (12 hrs. duration), weakness, muscular body aches all over. Symptoms commencing eleven (11) hours after dose 1. Ended in about 24 hours. Dose 2 - Myocardial infarction, Acute Congestive Heart Failure commencing eleven (11) hours after dose 2. Hospitalized 3 days. Symptoms of m/i: couldn't breathe, dizziness. 911 summoned.
65 2021-04-08 palpitations About 20 minutes after the vaccine injection, I became extremely weak, the weakness travelling from... Read more
About 20 minutes after the vaccine injection, I became extremely weak, the weakness travelling from my ankles up the rest of my body. I was too weak to walk and I was also dizzy, confused, and had heart pounding.
65 2021-04-09 loss of consciousness passed out; not feeling well; dizziness; could not get up; slept all day on and off; bruised knees; ... Read more
passed out; not feeling well; dizziness; could not get up; slept all day on and off; bruised knees; washed in cold sweat; nausea; fatigue; vomiting; bad headache; tender arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included METOPROLOL for Blood pressure. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (tender arm). On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MALAISE (not feeling well), DIZZINESS (dizziness), ASTHENIA (could not get up), SOMNOLENCE (slept all day on and off), CONTUSION (bruised knees), COLD SWEAT (washed in cold sweat), NAUSEA (nausea), FATIGUE (fatigue), VOMITING (vomiting) and HEADACHE (bad headache). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), MALAISE (not feeling well), DIZZINESS (dizziness), ASTHENIA (could not get up), SOMNOLENCE (slept all day on and off), CONTUSION (bruised knees), COLD SWEAT (washed in cold sweat), NAUSEA (nausea), FATIGUE (fatigue), VOMITING (vomiting), VACCINATION SITE PAIN (tender arm) and HEADACHE (bad headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient did not receive any treatment for the events. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
65 2021-04-09 platelet count decreased I received my fist dose of Moderna vaccine on 2/4 My platelet count was 186 on 2/17 I received my se... Read more
I received my fist dose of Moderna vaccine on 2/4 My platelet count was 186 on 2/17 I received my second dose of Moderna on 3/9 My platelet count dropped to 73 when checked on 3/12/2021 My platelet count dropped to 33 when checked on 3/29 I received a 2-week course of Prednisone starting on 3/29 My platelet count increased to 58 when checked on 3/30 My platelet count increased to 114 when checked on 4/2 My platelet count increased to 196 when checked on 4/8
65 2021-04-11 chest discomfort Itchy Eyes, Red Raised Bumps around Eyes, Scratchy Throat & inside ears, wheeze & tightness when br... Read more
Itchy Eyes, Red Raised Bumps around Eyes, Scratchy Throat & inside ears, wheeze & tightness when breathing , itchy neck red face, started around 1 hour 45 minutes after injection
65 2021-04-12 blood pressure increased, chest pain Client received Covid 19 vaccine at approx. 1530 to Rt. dlt. Per Client at approximately 1900 with... Read more
Client received Covid 19 vaccine at approx. 1530 to Rt. dlt. Per Client at approximately 1900 with a dry tight throat then started shaking incontrollable like being cold. Per client felt the same way when I had a reaction to prednisone. Then after an hour extreme headache and increase blood pressure, chest pain, shortness of breath, body aches and fatigue. Client voiced going to CMH ER around 1900. Client voiced IV fluids given and no dx of allergic reaction with Covid vaccine was given from Dr. in ER. Client refusal for 2nd dose- covid vaccine due to reaction from 1st vaccine. Client does believe her MS that was in remission has flared back up since being vaccinated with Covid.
65 2021-04-12 fainting The patient experienced an unknown taste after receiving Moderna as well as dizziness and fainting. ... Read more
The patient experienced an unknown taste after receiving Moderna as well as dizziness and fainting. She also had periods of feeling faint. The store management was called and alerted EMS which arrived after 20 minutes approximately. Basic vitals were taken and the patient was taken to the hospital.
65 2021-04-13 blood glucose increased Legs and knees started hurting during the night. Developed fever 102.2, body aches, headache, dizzin... Read more
Legs and knees started hurting during the night. Developed fever 102.2, body aches, headache, dizziness, cough, lethargy. Blood sugar 176 which is high for me. These symptoms lasted 2 days. Mostly laid around and slept. took tylenol for fever. cough drops for cough. 6 days after the injection developed sinus symptoms. Headache, sinus drainage, increased coughing. no fever. Taking tylenol sinus.
65 2021-04-13 chest pain, pulmonary embolism Bilateral pulmonary embolisms requiring ICU admission. Patient presented to Emergency Room on 4/13/2... Read more
Bilateral pulmonary embolisms requiring ICU admission. Patient presented to Emergency Room on 4/13/21 with presented to the ED with shortness of breath and chest pain. The patient notes that she developed shortness of breath, particularly with exertion, about 1 week prior to presentation. 2-3 days prior to presentation, she developed pleuritic chest pain on the right anterior chest. She denies any recent fevers, chills, weight changes, palpitations, cough, sputum production, abdominal pain, nausea, vomiting, diarrhea, constipation, lower extremity edema. She does note that she received her first dose of the COVID-19 vaccine on 3/16/2021 and was due for dose#2 on the day of admission. She denies a personal history of blood clots and denies current smoking, estrogen use, or recent surgery. She does note a history of blood clots in her sister, but she is unsure whether they were provoked or unprovoked. Patient required BiPAP on admission and was initiated on a heparin drip. Initial CT w/ some concern for R heart strain, however, echocardiogram showed no signs of R heart strain and she was hemodynamically stable. She was weaned from the BiPAP to Non-rebreather, and eventually nasal cannula. The heparin drip was transitioned to lovenox with plans to go home on a DOAC. Still hospitalized at time of event report.
65 2021-04-13 blood clot her left leg was swollen; two red clots on left leg; right feet was hurting; This spontaneous case w... Read more
her left leg was swollen; two red clots on left leg; right feet was hurting; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (two red clots on left leg) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (her left leg was swollen), THROMBOSIS (two red clots on left leg) (seriousness criterion medically significant) and PAIN IN EXTREMITY (right feet was hurting). At the time of the report, PERIPHERAL SWELLING (her left leg was swollen), THROMBOSIS (two red clots on left leg) and PAIN IN EXTREMITY (right feet was hurting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
65 2021-04-14 chest discomfort, chest pain Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Rash (specify: facial area, ext... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Rash (specify: facial area, extremities)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild.
65 2021-04-14 fibrin d dimer increased, superficial blood clot, fast heart rate, haemoglobin decreased Pt was admitted to the hospital on 4/13/2021 after being found to be covid 19 positive. She reported... Read more
Pt was admitted to the hospital on 4/13/2021 after being found to be covid 19 positive. She reported fever, cough and chills. she was febrile 101.2 and tachycardic. She was discharged home on 4/15/2021 on xarelto 10mg for 30 day and decadron 6mg for 3 more days. She was given regeneron during her hospital stay. It was also noted that she had a superficial venous thrombosis of the right greater saphenous vein extending into the upper thigh to the upper calf.
65 2021-04-14 heart rate increased Wednesday, March 31, 2021 Moderna vaccine, 2nd shot at 4:00pm. Arm began to feel sore about 10pm. Bl... Read more
Wednesday, March 31, 2021 Moderna vaccine, 2nd shot at 4:00pm. Arm began to feel sore about 10pm. Blood pressure and oximeter reading remained normal throughout. Thursday, April 1, 2021 Insufficient sleep, sudden increase in sinus congestion, muscle soreness and increasingly sore arm upon arising. Fatigue, Imbalance and Brain Fog rapidly increased. Urinary incontinence 3 times - once upon awakening and twice in the afternoon. Temperature began rising and reached 100.2°F by 3:00pm (normal temp 97.5°F). Resting pulse rate 74 at 10pm (normal 54). Headache and weakness in the evening. Friday, April 2, 2021 Insufficient sleep, sore arm, sinus congestion, sneezing, moderate headache, moderate imbalance, muscle soreness, weak, moderate brain fog. Resting pulse rate 64 (normal 54). Temp at 7:30am 99.4°F (normal 97.5°F). NEW today: joint pain in both hips and Tinnitus suddenly spiking high. 10:00pm noticed mood began to change, feelings of irritation then anger for no apparent reason. *Saturday, April 3, 2021 Insufficient sleep. Temperature at 12:30pm 98.1°F then continued to fall until it reached normal range (97.7°F) at 10:00pm. Resting pulse rate 68 (normal 54). Increasingly painful hip joints, sinus congestion still high, sneezing, mild headache, canker sores, tinnitus spiking, brain fog, increased imbalance. *NEW today: 7:30am-10:00am mental confusion, hallucinations, auditory, increased imbalance. Afterwards, feelings of fear, anger and paranoia that persisted through Sunday. Evening: increasing blurred vision and diplopia (both chronic conditions but usually very mild). Injection site suddenly red and more swollen, itching. Still feeling uncharacteristically emotional at bedtime. Sunday, April 4, 2021 Insomnia. Volatile emotions - anger, agitation, crying - kept me awake Saturday night; slept 2:30am-8:30am Sunday morning. Brain fog, imbalance, sinus congestion, sneezing, right arm itching, hip joint pain, canker sores on tongue, spiking tinnitus continue. Temperature normal all day; resting pulse rate still high 64 (normal 54). Monday April 5 through Thursday April 15: Most symptoms continued to gradually subside over the next ten days. Spiking tinnitus, canker sores and injection site itching were the most persistent and lasted until April 15. Imbalance subsided on April 12. NEW Symptoms: Anxiety dreaming began on April 6th. Most nights had insufficient sleep. Concern about the cause of the episode of delirium on April 3rd continues. Good news, no COVID-Arm like I had with the 1st vaccination. General observations: It seems as though my body's response to the 2nd vaccination was to temporarily trigger some of the symptoms of my chronic health conditions like MCAS, Dysautonomia and Diplopia, without causing an actual flareup of those conditions. This was quite unexpected and disconcerting. The episode of delirium was something I've never experienced and hope to never experience again.
65 2021-04-15 heart flutter fluttering sensation in the chest which was on and off/symptom came again and it was little more int... Read more
fluttering sensation in the chest which was on and off/symptom came again and it was little more intense; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (fluttering sensation in the chest which was on and off/symptom came again and it was little more intense) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 immunisation. The patient's past medical history included No adverse event (No medical history reported). On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC FLUTTER (fluttering sensation in the chest which was on and off/symptom came again and it was little more intense) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (fluttering sensation in the chest which was on and off/symptom came again and it was little more intense) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Description: The patient started experiencing fluttering sensation in the chest (medically significant) which was on and off and it was persisting for more than two weeks. The patient reported that last night the symptom came again and it was little more intense. The treatment information included antacid medications thinking it could be acid reflux issue. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
65 2021-04-15 cerebrovascular accident reports getting the moderna coviud vaccine on 03/16/2021 and then had a "stroke" 4-5 days after
65 2021-04-15 chest discomfort, heart flutter felt some fluttering in her heart; heavyness on her chest; Feeling strange; feeling funny; was so fa... Read more
felt some fluttering in her heart; heavyness on her chest; Feeling strange; feeling funny; was so fatigued; had shortness of breath; whole body was so sore and hurt so bad; started runnning a low grade fever; was freezing; uncontrollable shaking; whole body was jerking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (uncontrollable shaking), DYSKINESIA (whole body was jerking) and CARDIAC FLUTTER (felt some fluttering in her heart) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in September 2020. Family history included Hair loss in December 2020. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Allergy, LISINOPRIL for Blood pressure, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for Stomach ulcer, VITAMIN D3 and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TREMOR (uncontrollable shaking) (seriousness criterion intervention required), DYSKINESIA (whole body was jerking) (seriousness criterion intervention required), FREEZING PHENOMENON (was freezing) and PYREXIA (started runnning a low grade fever). On 03-Apr-2021, the patient experienced DYSPNOEA (had shortness of breath), FATIGUE (was so fatigued) and MYALGIA (whole body was so sore and hurt so bad). On an unknown date, the patient experienced CARDIAC FLUTTER (felt some fluttering in her heart) (seriousness criterion medically significant), CHEST DISCOMFORT (heavyness on her chest), FEELING ABNORMAL (Feeling strange) and INAPPROPRIATE AFFECT (feeling funny). On 02-Apr-2021, TREMOR (uncontrollable shaking), DYSKINESIA (whole body was jerking), FREEZING PHENOMENON (was freezing) and PYREXIA (started runnning a low grade fever) had resolved. On 04-Apr-2021, MYALGIA (whole body was so sore and hurt so bad) had resolved. On 05-Apr-2021, DYSPNOEA (had shortness of breath) and FATIGUE (was so fatigued) had resolved. At the time of the report, CARDIAC FLUTTER (felt some fluttering in her heart), CHEST DISCOMFORT (heavyness on her chest) and FEELING ABNORMAL (Feeling strange) had not resolved and INAPPROPRIATE AFFECT (feeling funny) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-067382 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD-2021-067382:first dose of vaccine case
65 2021-04-15 chest pain pain underneath her breast; chest hurt; bacterial pneumonia on left lower lobe; This spontaneous cas... Read more
pain underneath her breast; chest hurt; bacterial pneumonia on left lower lobe; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA BACTERIAL (bacterial pneumonia on left lower lobe) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The patient's past medical history included Diabetes, Asthma, Hypertension and High cholesterol. Family history included Heart disease, unspecified. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PNEUMONIA BACTERIAL (bacterial pneumonia on left lower lobe) (seriousness criterion medically significant). At the time of the report, PNEUMONIA BACTERIAL (bacterial pneumonia on left lower lobe) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Computerised tomogram: abnormal (abnormal) Pneumonia on left lower lobe.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. Treatment of the events included doxycycline. She had a CAT scan on 05Apr2021 because she had been having pain underneath her breast and her chest hurt. She had to cancel her second dose scheduled for 08Apr2021 due to the pneumonia. She had not been able to find appointment for her second dose and was concerned she may not be able to get the second dose. Company Comment: This case refers to a 65-year old female patient with relevant history of Diabetes, Asthma, Hypertension and High cholesterol who experienced Pneumonia bacterial, chest pain, and breast pain following the administration of Covid-19 vaccine and was assessed as Unlikely Related to study drug due to lack of temporal relationship. The subject's underlying disease history can be strong confounding factors. The pneumonia bacterial can be caused by bacterial infection and the immunocompromised system can allow the patient to higher risk for infections.; Sender's Comments: This case refers to a 65-year old female patient with relevant history of Diabetes, Asthma, Hypertension and High cholesterol who experienced Pneumonia bacterial, chest pain, and breast pain following the administration of Covid-19 vaccine and was assessed as Unlikely Related to study drug due to lack of temporal relationship. The subject's underlying disease history can be strong confounding factors. The pneumonia bacterial can be caused by bacterial infection and the immunocompromised system can allow the patient to higher risk for infections.
65 2021-04-15 chest pain Chest pains,light headed Difficulty breathing
65 2021-04-15 loss of consciousness Immed headache & lightheaded. Chills later in day. Sore arm, pain at injection site, fatigue, feeli... Read more
Immed headache & lightheaded. Chills later in day. Sore arm, pain at injection site, fatigue, feeling ?off.? Heavy sweating during night, pain felt in muscles & joints. Next Morn: achey, mild headache, fatigue, chills/sweats, no appetite. Later in afternoon became tingly , lightheaded, nausea, started blacking out, laid down. Injection site hot, red, swollen, itchy. Chills/sweats throughout night. Next day: felt better as day went on. Slight chills/sweats. Still feeling of ?off? and injection site warm, itchy.
65 2021-04-16 anaemia This could be coincidental to the vaccines, but I had blood work done on March 24 and am now anemic ... Read more
This could be coincidental to the vaccines, but I had blood work done on March 24 and am now anemic with elevated liver function. More testing is scheduled. I had no symptoms of anemia prior to the vaccines.
65 2021-04-16 heart rate increased After receiving the Moderna vaccine, she starts having a fast heartbeat (pulse 155/mins), and she st... Read more
After receiving the Moderna vaccine, she starts having a fast heartbeat (pulse 155/mins), and she still has this fast heartbeat for 30 mins. She called her PCP, and she wanted to go to the hospital to check her heart.
65 2021-04-17 hypertension, chest pain, palpitations All of a sudden started to feel lots of pain in my chest; Heart was really raising; Blood pressure f... Read more
All of a sudden started to feel lots of pain in my chest; Heart was really raising; Blood pressure felt high; Rash all over my neck and chest; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (All of a sudden started to feel lots of pain in my chest), PALPITATIONS (Heart was really raising) and HYPERTENSION (Blood pressure felt high) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced CHEST PAIN (All of a sudden started to feel lots of pain in my chest) (seriousness criterion hospitalization), PALPITATIONS (Heart was really raising) (seriousness criterion hospitalization) and HYPERTENSION (Blood pressure felt high) (seriousness criterion hospitalization). On 29-Mar-2021, the patient experienced RASH (Rash all over my neck and chest). The patient was hospitalized from 28-Mar-2021 to 29-Mar-2021 due to CHEST PAIN, HYPERTENSION and PALPITATIONS. On 29-Mar-2021, CHEST PAIN (All of a sudden started to feel lots of pain in my chest), PALPITATIONS (Heart was really raising) and HYPERTENSION (Blood pressure felt high) had resolved. At the time of the report, RASH (Rash all over my neck and chest) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Catheterisation cardiac: unknown (Inconclusive) unknown. On 28-Mar-2021, Echocardiogram: unknown (Inconclusive) unknown. On 28-Mar-2021, Ultrasound scan: unknown (Inconclusive) unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication included nitroglycerin given twice. Action taken with mRNA-1273 in response to the events was not applicable. On next day after second dose, while watching movie the patient had all of a sudden started to have lots of pain on her chest (never had this before), then her heart was really raising, and blood pressure felt high. This lasted for about seven hours. Patient went to hospital because patient thought was having a heart attack. Patient was given nitroglycerin which helped within a few minutes. Then they gave her another nitroglycerin and pain went down and was feeling no more pain. However, subject was admitted to the hospital and they did lots of test with one of them was a cardiac catherization, also echocardiogram and sonogram. Patient indicated her heart was fine, no heart attack, never experienced anything like that, and that next day, she had a rash all over my neck and chest. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested This case was linked to MOD-2021-073606 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
65 2021-04-17 oxygen saturation decreased Headache chills fever body aches lump in throat nausea followed by pneumonia low oxygen level very h... Read more
Headache chills fever body aches lump in throat nausea followed by pneumonia low oxygen level very high white blood count
65 2021-04-18 atrial fibrillation a fib
65 2021-04-18 blood pressure increased vein engorgement - arms, hands, legs, feet, chest; nose bleeds, calf pain; elevated blood pressure; ... Read more
vein engorgement - arms, hands, legs, feet, chest; nose bleeds, calf pain; elevated blood pressure; bruising
65 2021-04-18 cardiac arrest 101.5 fever Friday night, followed by a seizure at 3am. She was found unresponsive late Saturday af... Read more
101.5 fever Friday night, followed by a seizure at 3am. She was found unresponsive late Saturday afternoon, and was pronounced dead at the hospital. Sudden cardiac arrest.
65 2021-04-19 blood pressure increased 7 days post vaccine, swelling of left leg down to ankle with discomfort 9 days post vaccine, swellin... Read more
7 days post vaccine, swelling of left leg down to ankle with discomfort 9 days post vaccine, swelling and pain at injection site, with redness and hives. Increase swelling in left leg and ankle. Elevated blood pressure
65 2021-04-19 lightheadedness Lightheaded (Presyncope - per what I have read); more lethargic than typical and having to sleep lon... Read more
Lightheaded (Presyncope - per what I have read); more lethargic than typical and having to sleep longer; less stamina for typical aerobic exercise; shortness of breath at times. That this was not a direct result of the vaccination (which I experienced fever, aches and chills for 18 hours starting 12 hours post-shot) -rather the disequilibrium or presyncope symptoms began a couple of weeks later-is what was unexpected to me.
65 2021-04-20 blood glucose increased, oxygen saturation decreased Had moderate fatigue/malaise and mild progressive respiratory shortness of breath within 2 weeks of ... Read more
Had moderate fatigue/malaise and mild progressive respiratory shortness of breath within 2 weeks of the first vaccine, then progressed to severe after the 2nd vaccine and was hospitalized on 4/9/2021 with acute pneumonitis for 2 days with steroid treatment and Oxygen, discharged 4/11/21.
65 2021-04-20 blood pressure increased, blood clot Blood clot in Right leg and bilateral lungs. Patient also reported headache for >1 week, fatigue, sh... Read more
Blood clot in Right leg and bilateral lungs. Patient also reported headache for >1 week, fatigue, shortness of breath and blood pressure that elevated above 210 systolic.
65 2021-04-20 heart failure Spouse reported that patient was taken to The Hospital after unresponsive in the home on 4/2/2021. ... Read more
Spouse reported that patient was taken to The Hospital after unresponsive in the home on 4/2/2021. States was told that cause of death was heart failure.
65 2021-04-20 hypotension Patient experienced low blood pressure within 15 minutes of receiving the second Moderna vaccine and... Read more
Patient experienced low blood pressure within 15 minutes of receiving the second Moderna vaccine and became confused.
65 2021-04-20 loss of consciousness Passed out and broke foot; broke foot; lightheaded; Massive headache and couldn't lift her head up; ... Read more
Passed out and broke foot; broke foot; lightheaded; Massive headache and couldn't lift her head up; Not feel good; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out and broke foot) in a 65-year-old female patient who received mRNA-1273 (batch nos. 025B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 08-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced FEELING ABNORMAL (Not feel good). On 06-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out and broke foot) (seriousness criteria medically significant), FOOT FRACTURE (broke foot), DIZZINESS (lightheaded) and HEADACHE (Massive headache and couldn't lift her head up). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out and broke foot), FOOT FRACTURE (broke foot), DIZZINESS (lightheaded) and HEADACHE (Massive headache and couldn't lift her head up) had not resolved and FEELING ABNORMAL (Not feel good) outcome was unknown. Not Provided For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication included medication for thyroid. Treatment information included for an events Advil and Aleve. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
65 2021-04-21 heart rate increased, chest pain Chest pain, fast heart beat - painful lasted for 3 day. Couldn't fall asleep
65 2021-04-22 chest discomfort Patient got 2nd dose of moderna, after few minutes she was experiencing heaviness in her chest and ... Read more
Patient got 2nd dose of moderna, after few minutes she was experiencing heaviness in her chest and slight shortness of breath. monitored her blood pressure for 20 minutes. Finally after 20-30 minutes she started feeling better. Patient said she doesn't take her blood pressure medication daily, takes only as needed. counseled her to take it daily. Tried checking with her after couple of hours, unable to reach her on the phone
65 2021-04-22 chest pain chest pains
65 2021-04-22 palpitations, blood pressure increased i had no adverse reaction til about 12 hours after the vaccine. terrible headache in back and front... Read more
i had no adverse reaction til about 12 hours after the vaccine. terrible headache in back and front of head, nauseous and throwing up. i was not right for over a week. heart was pounding and head. i was very ill for about 24 hours - i almost called an ambulance to go to the er cause i could not have driven. after 8 days i went to a cardiologist as i was still not right. not myself. exhausted. could feel my heart beating and pressure was higher than normal.
65 2021-04-24 blood pressure increased Beginning morning after vaccine (4/23/2021) had mild headache and sinus pressure. At noon, suddenly... Read more
Beginning morning after vaccine (4/23/2021) had mild headache and sinus pressure. At noon, suddenly extremely tired and weak, went to bed, headache increased to a "10". Body aches waist down began, ("10") sinus pressure increased to a "10", chills and shaking were so bad my spouse had to put 5 blankets on me and hold me in bed for 2 hours, dizziness and vertigo caused walking by myself without support of some kind, impossible, fever began about 2pm started at 100.3 and quickly went to 103, subsided after Tylenol to 101 about 2 hours after began. Blood pressure elevated from 127/74 (my normal) to 167/85 for 3 hours, then stayed high at 145/85 for 24 hours more. Called Urgent care who told me to go to ER if Blood pressure elevated more or temp stayed at 103 for very much longer. Could not take Sudafed due to elevated BP, so had to suffer through sinus pressure, worse I have ever experienced. I was so depressed from the chills and feeling so badly I cried. I felt as though I were dying. This sounds dramatic, but it truely was how I felt. I had the flu 2 year in a row even though I had been vaccinated and these Moderna side effects were worse than the flu.
65 2021-04-24 blood clot, chest discomfort, heart rate increased Second vaccine given 3-4-21 on 4-21-21 was treated at the ER for blood clot in right calf . My ... Read more
Second vaccine given 3-4-21 on 4-21-21 was treated at the ER for blood clot in right calf . My calf was tight and a bit swollen. My heart beat was rapid with shoulderblade pain and tightness in chest. Tightness and blade pain started on 4/20 pm with a hard calf. Morning pain worse and leg was more swollen and warm
65 2021-04-25 pulmonary embolism, chest discomfort Shortness of breath; Difficulty breathing; Heaviness in chest; Went to ER and had chest x-rays and C... Read more
Shortness of breath; Difficulty breathing; Heaviness in chest; Went to ER and had chest x-rays and CT scan of my lungs. Found out I had numerous pulmonary embolisms in all 5 lobes of my lungs. They did a COVID test and it was negative. They did an EKG and sonogram on my heart and it was fine. They checked for blood clots in my legs. There were none. They checked for signs of cancer. There were none. They started a heparin drip through my IV and the dissolved the largest clot with an embolectomy. I'll be on blood thinners for 6 months.
65 2021-04-25 pulmonary embolism March 31, I woke up with very stiff joints, making walking and doing household chores exceedingly di... Read more
March 31, I woke up with very stiff joints, making walking and doing household chores exceedingly difficult. This lasted for 5 days. Beginning on April 5th I felt like I could not catch my breath, so I called my doctor?s office for an appointment; I saw the PA and she felt I needed to have an EKG. I called them and the earliest I could see them was the 20th. I contacted my Doctor?s office, and they sent an order for the testing ASAP, I never received a call from them to reschedule. As the week continued, I got worse and went to the ER. After numerous tests and blood draws, I was admitted to the hospital. I spent 2 days in the hospital, 24 hours on oxygen.
65 2021-04-27 heart rate increased 36 hours post 1st shot: Immediate onset of severe neck pain, chills, body aches, headache 101 fever,... Read more
36 hours post 1st shot: Immediate onset of severe neck pain, chills, body aches, headache 101 fever, red circle and knot at injection site, felt strange. The following day, I developed a severe rash on my upper abdomen, chest, back and face. On 04/10/21, my arm at injection site turned raised and red; freezing cold hand, tips of my fingers were numb for 45 minutes, itching, fast heart rate, extreme pain in left shoulder blade. On 4/26/21 I had a mammogram which showed 2 small masses (5 mm x 5 mm) and prominent lymph node left arm pit. Biopsies are scheduled on 5/6/21.
65 2021-04-28 chest pain, arrhythmia Within 3 days had severe itching all over including eyes, scalp and legs, antihistamines did not wor... Read more
Within 3 days had severe itching all over including eyes, scalp and legs, antihistamines did not work, flu like feeling, felt bad all over, spent alot of time in bed or recliner, fatigue with no energy, heart arrhythmia, Dr. ordered heart monitor to be worn, chest pain, occasional body tremors and off balance, no rash, somewhat improved almost a month later
65 2021-04-29 deep vein blood clot On 4/19/21, Pt began with pain in her left leg. Pain continued to worsen so that she could not slee... Read more
On 4/19/21, Pt began with pain in her left leg. Pain continued to worsen so that she could not sleep at night and she became unstable on her feet. On 4/23, she developed a 102 degree fever, severe nausea and severe abdominal pains and she drove to Hospital ER on 4/24. She was diagnosed with Deep Vein Thrombosis behind her left knee.
65 2021-04-29 hypotension, blood glucose increased pt stated low blood pressure after shot and sugar levels rose but have begun to come down
65 2021-04-29 loss of consciousness Morning after vaccine became dizzy and passed out. One week later on April 16, 2021 woke up with my... Read more
Morning after vaccine became dizzy and passed out. One week later on April 16, 2021 woke up with my head feeling like I was on an airplane. Heard echos and vibration everytime I spoke or someone spoke to me in my left ear (right ear is deaf due to Acoustic Neuroma surgery). April 19, 2021 saw the ENT. Hearing test showed decline in hearing in my good ear. He put me on Prednesone. Today April 30, 2021 echo is gone. Will be going in to check my hearing next week.
65 2021-04-30 deep vein blood clot dvt- gastrocnemius vein right leg
65 2021-04-30 heart rate increased Left sided numbness and tingling, and foot drop.diarrhea, POTS -like elevated heart rate ,itching,w... Read more
Left sided numbness and tingling, and foot drop.diarrhea, POTS -like elevated heart rate ,itching,weakness ,burning feet and vascular inflammation. Caused me to have reaction to all usual medications. Swelling on forehead, rash on leg and around mouth. Red fingertips Tinnitus. Lump on neck, ,bright red nose and cheeks.
65 2021-04-30 fluid around the heart pleural and pericardial effusions
65 2021-05-02 chest pain At time of injection, had immediate pain strong enough to cause me to have to stifle a scream. Day ... Read more
At time of injection, had immediate pain strong enough to cause me to have to stifle a scream. Day 1 and Day 2 experienced pain in arm. Injection site Bruised. Beginning around Day 3, began to suffer pain from injection site up to shoulder and into neck area. Pain was intermittent, but strong enough to wake me in the night and was unable to get back to sleep until I took Tylenol and applied heat. The pain worsened over next couple of weeks and began feeling it down my left side and into chest area. Began taking Tylenol and applying heat at night and every morning. Injection site bruise was still visible after 3 weeks. After 4 weeks, finally have fewer episodes of pain. Injection site is still sore to touch and at times I feel a burning sensation in the injection site.
65 2021-05-03 chest discomfort About 4 minutes after receiving the vax, I developed an odd taste in the back of my throat. Then I b... Read more
About 4 minutes after receiving the vax, I developed an odd taste in the back of my throat. Then I became dizzy, felt like I was going to faint and had to put my head between my legs to keep from passing out. My mouth became dry, and I broke out in a sweat. My fingertips/hands became tingly. I felt like I could not catch my breath and started hyperventilating until the pharmacist verbally helped me to calm my breathing.
65 2021-05-03 chest pain, hypertension, fibrin d dimer increased Headache, chest pain , muscle pain, high blood pressure
65 2021-05-03 deep vein blood clot pt developed DVT
65 2021-05-03 deep vein blood clot left lower extremety swelling, redness, pain within one week of second COVID vaccine. DVT confirmed ... Read more
left lower extremety swelling, redness, pain within one week of second COVID vaccine. DVT confirmed at ED visit.
65 2021-05-03 fainting, loss of consciousness Syncope, Diaphorisis, Loss of concscienceness
65 2021-05-04 loss of consciousness passed out; can't walk very well without assistance; Sleepy; Very weak; headache; In appropriate dos... Read more
passed out; can't walk very well without assistance; Sleepy; Very weak; headache; In appropriate doses interval, more than 35 days; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma (Taking asthma medication as concomitant). On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (In appropriate doses interval, more than 35 days). On 20-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), GAIT DISTURBANCE (can't walk very well without assistance), SOMNOLENCE (Sleepy), ASTHENIA (Very weak) and HEADACHE (headache). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), GAIT DISTURBANCE (can't walk very well without assistance), SOMNOLENCE (Sleepy), ASTHENIA (Very weak) and HEADACHE (headache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (In appropriate doses interval, more than 35 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Computerised tomogram: (Negative) negative. On 23-Apr-2021, X-ray: (Negative) negative. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient's heart was checked but no abnormal results. Company comment: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot # 013M20A with associated AEs(loss of consciousness, gait disturbance, somnolence, asthenia and headache). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot # 013M20A with associated AEs(loss of consciousness, gait disturbance, somnolence, asthenia and headache). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
65 2021-05-04 pulmonary embolism Patient arrived to the healthcare facility with complaint of left upper quadrant abdominal pain on a... Read more
Patient arrived to the healthcare facility with complaint of left upper quadrant abdominal pain on and off for approx 2 weeks. Noticed it began shortly after receiving the COVID vaccination. On April 15th, patient stated they had an increase in the left upper quadrant abdominal pain and new shortness of breath. Upon admission to ED patient had CT angio chest with contrast completed, results showed b/l pulmonary embolism with distention of the main pulmonary artery.
65 2021-05-07 palpitations, platelet count decreased Heart started racing they took my blood pressure and it was 189/125. They checked it every 15 minute... Read more
Heart started racing they took my blood pressure and it was 189/125. They checked it every 15 minutes and after an hr they put me in a wheelchair to the ER. They drew blood and my platelets were 91. After 3 hrs when my blood pressure was in a safe range they sent me home.
65 2021-05-08 fainting Dose 1: aching that immediately moved from injection site down to wrist / top of hand and remained ... Read more
Dose 1: aching that immediately moved from injection site down to wrist / top of hand and remained there - 4 days; soreness at injection site - 7 days; headache - 2 days; tiredness - 5 days; diarrhea - 12 hours and again on day 7 Dose 2: feinted on day 2; lightheadedness requiring prone position with legs elevated - 3 days; lightheadedness that randomly arrives - still occurring; severe headache - 4 days; migraine and nausea - 1 day; severe leg and foot muscle cramping - 2 days; burning / itching feet and hands w/ under-skin welts - 4 days; flu-like symptoms of high fever - chills - achiness for 3 days; soreness at injection site - 7 days; severe tiredness - 5 days Used OTC: Advil and Benadryl
65 2021-05-09 heart rate increased, heart rate irregular Patient c/o fast heart rate 4 min post vaccine. Assessed patient A&ox3 zero c/o sob, or chest pain. ... Read more
Patient c/o fast heart rate 4 min post vaccine. Assessed patient A&ox3 zero c/o sob, or chest pain. v/s at 10:43am BP 142/68 HR 112 RR 20 SPO2 96%. Provider recommending to monitor patient for 15 min. v/s at 11:08 BP 140/60 HR 110 RR 18 SP02 97% No new complaints but patient states still feeling like her heart will beat really fast then slow down. Provider recommending to monitor again for another 15min patient refused to wait for another 15 min because she needed to use the restroom and did not want to stay for further observation. Provider advised patient that she needs to make an appointment with a provider today patient agreed, but left vaccine site against medical advise from the provider to stay for further observation. Left vaccine clinic at 11:20 am.
65 2021-05-10 coughing up blood, nosebleed On January 25, 2021 I developed extreme tinnitus primarily in my right ear 8 hours after my injectio... Read more
On January 25, 2021 I developed extreme tinnitus primarily in my right ear 8 hours after my injection ( although sometimes in both ears or just left ear). It stopped at times and varied in the quality. Sometimes pounding like a bass drum beating in random Morse code, sometimes in sync with my heart beat. Sometimes I could stop it by tipping my head back, though not always. It was so loud it affected my ability to hear what others were saying. I had a sinus infection and probable lung infection (was coughing up a lot of dark green phlegm at the time I got the injection and had coughed up blood a few times the week before my vaccination + had had a minor bloody nose with the coughing up blood.) Started antibiotics on January 27. This helped with the sinus/lung infection but the tinnitus continued for 5-1/2 weeks. It stopped about 3 days before I got my 2nd vaccination. (Because of supply shortage, I had to wait almost 6 weeks before getting dose #2.) I did not have this reaction to dose #2. Today I occasionally hear minor bass drum-like beats, but is rare and much quieter.
65 2021-05-10 blood clot Saturday 30 minutes after administration patient felt nausea lethargy and stiff neck and back. Nex... Read more
Saturday 30 minutes after administration patient felt nausea lethargy and stiff neck and back. Next morning Sunday patient woke with a fever of 99.6 and large blood clot in mouth. Two days post vaccine Monday patient work with large blood clot on pillow. That evening patient had 2 more blood clots spontaneously coming from teeth. Tuesday morning upon arising from chair pt experienced an intense metallic taste. Patient then experienced several 8 mouth fulls of blood on 3 occasion in same evening. Patient states it was pushing out from gums.
65 2021-05-12 haemoglobin decreased I have an underlying condition called PMH. My hemoglobin went down after the first dose of the vacci... Read more
I have an underlying condition called PMH. My hemoglobin went down after the first dose of the vaccine, but I was given Prednisone. After the second dose I had a fever of 101 the day after the vaccine and 103 on the second day. I was very tired for the next few days and I had trouble getting out of my chair. My hemoglobin was very low again and I was given a blood transfusion six days after the second dose of the vaccine. I had been taking Prednisone 15mg/daily since having the first dose so that protected me a little. I have not had any more problems since that time.
65 2021-05-12 palpitations Heart palpitations, shortness of breath, head ache, tingling in right hand, sore right arm
65 2021-05-13 heart rate increased Within 10 minutes of administration, I didn't feel right. I experienced fast heartbeat, chills, my ... Read more
Within 10 minutes of administration, I didn't feel right. I experienced fast heartbeat, chills, my face turned red, my head felt numb, I couldn't stop shaking from feeling cold, especially my legs. The pharmacist gave me water and peanut butter crackers. It got worse before it got better. My husband got a blanket out of the car to wrap me in. The pharmacist also gave me ibuprofen. My husband bought some benadryl and I took that. It was close to an hour before I felt better and could go home.
65 2021-05-13 bleeding on surface of brain, ventricular tachycardia Spontaneous Cortical Non aneurysmal subarachnoid hemorrhage with diagnostic suspicion but not confir... Read more
Spontaneous Cortical Non aneurysmal subarachnoid hemorrhage with diagnostic suspicion but not confirmation of cortical venous thrombosis, and spontaneous ventricular tachycardia.
65 2021-05-16 heart rate increased nausea, headache,102 degree fever, body aches fast heart rate, tremor, weakness, disorientation, cou... Read more
nausea, headache,102 degree fever, body aches fast heart rate, tremor, weakness, disorientation, couldn't stand colors, TV, audio books, cough, very sore arm, too weak to walk, almost collapsed, swelling in underarms, lumps in neck. Symptoms started 24 hours after vaccination. They lasted 24 hours. But was week and still nauseous the next 24 hours and then mouth and lips broke out in blisters, had migraine headache. No treatment. Couldn't drive.
65 2021-05-17 blood pressure increased Approximately 46 hours after my 2nd shot, I started to become dizzy. My blood pressure rose to 161/9... Read more
Approximately 46 hours after my 2nd shot, I started to become dizzy. My blood pressure rose to 161/96. From 4/14/2021 through 4/25 /2021I experienced dizziness and nauseous effects to the point of feel like I was gagging. However, I would feel better if I sat perfectly still. When I would get up and start to move around the house, the symptoms resumed. It seemed to mimic motion sickness.
65 2021-05-17 hypotension, low blood oxigenation, very slow heart rate Summary Note: Rash, itching, hives, SOB, hypotension, hypoxia, hypothermia, bradycardia, muscle pain... Read more
Summary Note: Rash, itching, hives, SOB, hypotension, hypoxia, hypothermia, bradycardia, muscle pain and aches, severe headache, nausea, vomiting, diarrhea, lethargy, severe site pain right upper arm 2" below injection site measuring approximately 2" x 3" with rigid hardness at site.
65 2021-05-17 hypotension, fainting Collapsed; large hematoma on the back of head; feeling very weak; Woozy and Headachy; flat on my bac... Read more
Collapsed; large hematoma on the back of head; feeling very weak; Woozy and Headachy; flat on my back on the bathroom floor; quite disoriented; memory of what happened next is a little hazy; attempted to get up once and was unsuccessful; Low Blood Pressure; gash open my front lip in the fall; Woozy and headachy; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Collapsed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dust allergy, Pollen allergy, Grass allergy, Ragweed allergy and Seasonal allergy since 1960. Concomitant products included CALCIUM, COLECALCIFEROL (CALCIUM WITH VITAMIN D3 [CALCIUM;COLECALCIFEROL]) for Osteoporosis. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced SYNCOPE (Collapsed) (seriousness criteria hospitalization and medically significant), DIZZINESS (Woozy and Headachy), FALL (flat on my back on the bathroom floor), DISORIENTATION (quite disoriented), AMNESIA (memory of what happened next is a little hazy), DYSSTASIA (attempted to get up once and was unsuccessful), HYPOTENSION (Low Blood Pressure), LIP INJURY (gash open my front lip in the fall) and HEADACHE (Woozy and headachy). On 19-Mar-2021, the patient experienced ASTHENIA (feeling very weak). On an unknown date, the patient experienced HAEMATOMA (large hematoma on the back of head). At the time of the report, SYNCOPE (Collapsed), DIZZINESS (Woozy and Headachy), FALL (flat on my back on the bathroom floor), DISORIENTATION (quite disoriented), AMNESIA (memory of what happened next is a little hazy), DYSSTASIA (attempted to get up once and was unsuccessful), HYPOTENSION (Low Blood Pressure) and HEADACHE (Woozy and headachy) had resolved and ASTHENIA (feeling very weak), HAEMATOMA (large hematoma on the back of head) and LIP INJURY (gash open my front lip in the fall) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) 85/45. On an unknown date, Computerised tomogram: negative (Negative) brain bleed (negative). On an unknown date, X-ray: negative (Negative) negative. Treatment for the events included aspirin and intravenous saline. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: updated concomitant medications, treatment information, and medical history.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
65 2021-05-17 loss of consciousness Within one hour; my arm was sore. I started my day on 5/14 at 0500. I felt woozie so I sat down ... Read more
Within one hour; my arm was sore. I started my day on 5/14 at 0500. I felt woozie so I sat down for a few minutes. When I got up, I passed out onto the kitchen floor. I got and and started to vomit. I went back to bed. I work every few hours to continue vomiting and dry heaves. I was better on Saturday morning but very weak. My kidneys hurt on Saturday and I spilled blood in my urine. My uring was clear by Sunday morning. I was able to keep food and fluids down as of Saturday morning. As of this morning, 5/18 I am still weak.
65 2021-05-18 platelet count decreased, blood pressure increased, low blood platelet count Noticed bleeding in the mouth/gums. Looked inside and found bloody holes in my cheeks about 1/2" big... Read more
Noticed bleeding in the mouth/gums. Looked inside and found bloody holes in my cheeks about 1/2" big. I noticed the top of my hands we also very bruised although I did not get hurt. I went to the ER and they took me in and ran blood tests. They diagnosed me with Immune Thrombocytopenia Purpura. My platelet level was at 8,000, and 6 months prior I was at 180-200,000. They began giving me platelets and were working up to giving my Immunoglobulen. After 2 doses of platelets they gave me 2 doses of benadryl intravenously and I had a scary reaction (I've never had a reaction to benadryl prior to vaccine). My body went numb, it felt like my muscles fell asleep, I felt like I could not breath. It's as if my body attacked anything that came in. Then I was given a sedative to calm down. As the sedative faded I began feeling immense pain in my abdomen, they thought it was internal bleeding, but after a CT scan they found 3 kidney stones. I was then put on fluids. Due to pain, my blood pressure went up and stayed up for about 8-10 hrs at around 255. I was given about 3 does of blood pressure medication throughout that time to lower it as well as morphine to help with the pain. The next morning (Day 3) I was finally given the Immunoglobulin (3 bottles = 1 dose). platelets went up to about 60,000. Then I was given a second dose and released on day 4 (but the second dose was not completed in full, only 1 or 2 bottles of the 3 were given. I was released and came back after 2 days for a blood test. I was given steroids to take for a few months. My platelets were at 120,000. I thought that I was getting better, but then a few days letter came in for another blood test and it showed I was back at 60,000 platelets. Thats where I am now.
65 2021-05-19 hypertension itchy all over in both arms, face, high blood pressure, dizziness, hives
65 2021-05-20 chest discomfort, atrial fibrillation, palpitations loss of taste and small April 18 - 24, 2021 Racing heart rate, significant weight/pressure on chest,... Read more
loss of taste and small April 18 - 24, 2021 Racing heart rate, significant weight/pressure on chest, difficulty catching breath: - first episode April 24, 2021 - second episode included cold sweats May 4, 2021. I called 911 and was transported to Emergency Department. ED team diagnosed issue as atrial fibrillation.
65 2021-05-21 fast heart rate Experienced SVT at 4:45 AM the day after 2nd vaccination (heart rate =219 bpm. SpO2=99%). Took25 m... Read more
Experienced SVT at 4:45 AM the day after 2nd vaccination (heart rate =219 bpm. SpO2=99%). Took25 mg metoprolol tartrate. Rythm broke at 5:20 AM, when heart rate returned to 98 bpm, SpO2=98%.
65 2021-05-22 heart rate increased Fevers; body aches; lower extremity cramps; fast heart rate overnight. Self resolved.
65 2021-05-23 chest pain, hypertension, heart rate increased On 3/21/21 experienced Increased coughing, shortness of breath, rapid heart beat even when resting, ... Read more
On 3/21/21 experienced Increased coughing, shortness of breath, rapid heart beat even when resting, fatigue, high blood pressure, difficulty sleeping, increased asthma, chest pain Went to on 3/24/21 Primary Care Dr. who prescribed using Advair 250/50, Albuterol Sulfate, and Ipratropium bromide Inhaler four times per day. she ordered blood work and COVID testing 3/26/21 Went to ER with severe chest pain and difficulty breathing and was treated by both the ER Dr. and Cardiologist Doctor . The EKG did not show a heart attack. They applied oxygen and Suggested I see a pulmonologist and follow up with Cardiology. Passed a kidney stone on 3/31/21 and brought it in for analysis on 4/6/21 4/6/21 met with APRN in Cardiology to review symptoms, she ordered a limited Echo. Subsequently she ordered a Zio Patch Heart study to collect data over a 2 week period 4/22/21 met with Pulmonologist Dr. she suggested that I needed to meet with ENT to rule out allergies and she increased the Advair to 500/50 and she ordered blood work which was done on 4/26/21 4/29/21 met with APRN in ENT Dr. office for a scope to determine if allergies, Acid Reflux, or sinus issues existed. The scope showed only a bit of scare tissue may be pressing against the voice box which might cause a cough so she ordered a CT scan of the neck (scar tissue from previous intubation 15 years ago) 5/18/21 ZioXT Patch installed 5/18/21 at 1:50 to be worn for 2 weeks to record unusual events with the heart 5/19/21 Revisited Dr. who summarized that blood work was normal. 5/21/21 had Limited Echo Cardiogram which showed no significant difference from previous echo done one year prior. 5/25/21 follow scheduled with primary care Dr. 6/17/21 follow up scheduled with Dr. in ENT to do a further study of the scare tissue found below voice box 7/9/21 flow up schedule with Dr. 7/19/21 Follow up scheduled with Dr. Patient (me) is feeling better, still experiencing cough and heart chest pain and breathing issues but not as difficult as before.
65 2021-05-25 deep vein blood clot, pulmonary embolism Dose 1 - 1/19/21 - On 1/26/21, I got developed a bad case of SOB. I called my cardiologist and she t... Read more
Dose 1 - 1/19/21 - On 1/26/21, I got developed a bad case of SOB. I called my cardiologist and she told me to get tested for COVID. I went to the county facility to get tested and it took 3 days for results, which finally came back negative. During my wait, I went to a Urgent care and they did a Chest Xray, EKG and another COVID test, which was negative and the other tests were normal. I was sent back to cardiologist. She scheduled a stress text on 2/11 and everything was fine. I was also feeling fine by then. Dose 2 - 2/16/21 - The next day, I had a headache, aches, pain, fever and basically felt like I had the flu. I took Tylenol and that lasted about 36 hours. On 2/25, I was doing my 2 mile walk and I start experiencing the SOB again. So, I relaxed and figured it would go away. On 3/1, we drove to a park and back home 3 days later. On 3/3, I was really exhausted, so I took a nap for 3 hours and awakened with calf pain and a low grade fever. That lasted for 3 days, so I went to the ER on 3/6. They did an ultrasound on my leg and found a DVT in my right leg. They did CT Scan of my lung and found several clots (pulmonary emboli). I was in the hospital overnight and put me on a blood thinner, Eliquis 5mg, twice a day. Since then, I've continued to take the Eliquis and I'm following up with a hematologist on June 21. The hematologist has already tested me for two factors came negative and he will test me for the third one at my next visit.
65 2021-05-25 platelet count decreased, low platelet count, low blood platelet count, haemoglobin decreased presents 5/8/2021 with red/bloody lesions inside bilateral cheeks, lower lips for the past 5 days o... Read more
presents 5/8/2021 with red/bloody lesions inside bilateral cheeks, lower lips for the past 5 days or so. Patient denies any new medications. Patient denies any pain in her body, she noted increased bruising (right hand), and small dots on her skin appear everywhere. She has never had low platelets before. She denies taking any new supplements. She only takes levothyroxine and no other medications at home. She denies taking Aspirin and denies . admit to inpatient Med Surg, patient with most likely ITP with wet purpura, diffuse petechiae and with platelet of 12K. Patient is currently not actively having any without GI bleed or profuse bleeding. HGB 12.0 Patient received IV IG infusions on 5/11 and 5/12, as well as continued steroids, and received platelets transfusions , Platelets improved to > 50 K by 5/12/2021 , and felt well and ready to go home . On 5/25/21 patient readmitted due to worsening thrombocytopenia during outpatient follow-up. At last admission, patient had thrombocytopenia with minor oral bleeding and petechial rash, and was sent home on steroid taper. Patient reports tapering down on prednisone as directed, but she began to note increased bruising all over her body, most prominently on her arms. Notes her gums began to ooze again a couple days ago. No hematuria, no melena or dark tarry stools. will treat with IVIG 1g/kg and rituximab.
65 2021-05-25 pulmonary embolism, atrial fibrillation, deep vein blood clot Initially, experienced swelling in left foot, leg, progressive pain, difficulty walking. Referred ... Read more
Initially, experienced swelling in left foot, leg, progressive pain, difficulty walking. Referred for test, after seeing doctor on 4/21/21, progressive pain, gradual and increasing shortness of breath. Went to Urgent care on 4/26/21. Recommended Emergency care. Hospitalized 4/26/21 to 4/30/21. Diagnosed DVT, Pulmonary Embolism, Afib.
65 2021-05-26 blood pressure increased MD contacted prior to administering second vaccine to report patient's statement of previous occurre... Read more
MD contacted prior to administering second vaccine to report patient's statement of previous occurrence after first vaccine. MD instructed nurse okay to administer but to monitor for minimum of 30 minutes. After administration of vaccine, nurse allowed patient to sit in a chair within easy viewing range. Patient began to rub right eye and upon assessing and reports "some blurriness to vision". Nurse then performed a manual BP check and found patient's BP to be 160 systolic. Patient states she "sometimes has high blood pressure" but doesn't check on a regular basis. After continuing to monitor for over hour bp was 140 systolic. Snellen eye chart used to assess vision and patient found to have 20/20 vision. Patient educated to contact her PCP with any further questions or concerns that were non emergent. On 5/27 nurse contacted patient via phone and patient reported that her bp did increase again later that evening and she contacted her PCP and went to see to address home medications. Patient then reported that her only complaint was "a bit of a sore arm".
65 2021-05-26 chest pain The day after the injection I started to experience symptoms of pleurisy. I am familiar with these s... Read more
The day after the injection I started to experience symptoms of pleurisy. I am familiar with these symptoms as I had pleurisy in my youth. There was some difficulty breathing and chest pain. The chest pain continues to this day.
65 2021-05-26 loss of consciousness After I woke up at ~6:30a, I felt nauseated, so I walked 30' to ask my husband (working) to get our ... Read more
After I woke up at ~6:30a, I felt nauseated, so I walked 30' to ask my husband (working) to get our daughter ready for distance school. I felt no other symptoms and I fell unconscious when I was nearly back to the bed. I am still recovering from a "moderate/severe concussion" per ER notes and received 14 stitches on my scalp. I continue to have some memory issues, some problems with word selection which I did not have prior to this event. During these 10 weeks it is significantly improved, I am concerned about getting the booster vaccine when needed however.
65 2021-05-27 heart rate increased, hypertension After the vaccination, I went to the ER. They said they weren't finding anything wrong with me. My b... Read more
After the vaccination, I went to the ER. They said they weren't finding anything wrong with me. My blood pressure was high and my heart was beating very fast. I was there several hours for them to watch me. They did blood tests and they did an x-ray of my lungs. They released me because my condition wasn't getting any worse, and my numbers went down a little bit. They sent me home to take a benadryl and go to bed. They also said my symptoms could be related to an anxiety attack after being home for a year alone with my cat and then going out into the public. When I went home and took the benadryl and went to bed, I felt fine the next day.
65 2021-05-31 hypertension Dizziness, lightheadedness, hypertension to 180/90
65 2021-06-01 blood pressure fluctuation Developed Dress Syndome, Also rash covering 60/70% of my body , Fluctuating blood pressure , Plus tu... Read more
Developed Dress Syndome, Also rash covering 60/70% of my body , Fluctuating blood pressure , Plus tumor andd Lieomyo Sarcoma. Recently vision problem which MD states could be caused by adverse reaction to vaccine.
65 2021-06-01 cerebrovascular accident Stroke
65 2021-06-01 palpitations, arrhythmia I started to get an Arrhythmia; Palpitation; I am dizzier; this is aggravating of my pre-existing co... Read more
I started to get an Arrhythmia; Palpitation; I am dizzier; this is aggravating of my pre-existing conditions/my acid reflux is no longer base line; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (I started to get an Arrhythmia) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dizziness since 1992, Malabsorption, Anaemia since 1992, LBBB since 26-Feb-2021 and GERD since 2000. Concomitant products included ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for Acid reflux (oesophageal), ALPRAZOLAM for Imbalance hormonal. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (I started to get an Arrhythmia) (seriousness criterion medically significant), PALPITATIONS (Palpitation), DIZZINESS (I am dizzier) and CONDITION AGGRAVATED (this is aggravating of my pre-existing conditions/my acid reflux is no longer base line). At the time of the report, ARRHYTHMIA (I started to get an Arrhythmia), PALPITATIONS (Palpitation), DIZZINESS (I am dizzier) and CONDITION AGGRAVATED (this is aggravating of my pre-existing conditions/my acid reflux is no longer base line) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement (120-80): 184/110 (High) high and high (High) 140-150/80-90. In 2021, Heart rate: high (High) Rise in pulse rate. Patient have numerous allergies which are not reported. Treatment information provided included 1mg of unknown medication. Action taken with mRNA-1273 in response to the events was not applicable. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-080355 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
65 2021-06-03 hypertension On the day of vaccination I had pain in elbow and light headed with dizziness, rash on lower part of... Read more
On the day of vaccination I had pain in elbow and light headed with dizziness, rash on lower part of arm that came and went, my lets now have a red rash that doesn't itch but it's there, now my legs swelled up , high BP, swollen legs, chills, my feet swollen and continue to get huge and I can't bend my toes or ankles, now I've started having incontinence. Also the pain is unbelievable.
65 2021-06-05 heart attack INITIALLY: Patient described having Flu- like symptoms of fatigue, body aches, also nausea within ho... Read more
INITIALLY: Patient described having Flu- like symptoms of fatigue, body aches, also nausea within hours of receiving the vaccine. She had to stay in bed for 2 days because of it and her arm was "extremely" sore, and the symptoms were on and off for the subsequent 2 weeks. THEN: Patient gets admitted to the hospital on 5/15/21 (two weeks from the shot) for a HEART ATTACK. She presented with atypical symptoms, describing a "pulling sensation" in the back of her head and extreme weakness where she couldn't stand. Patient was then hospitalized twice due to the heart attack, and will require open heart surgery which she is scheduled for later this month. Patient is on several new medications now.
65 2021-06-06 chest discomfort, chest pain Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: she stated she had severe b... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: she stated she had severe burning feeling in bilateral lungs that lasted for 24 hours
65 2021-06-07 excessive bleeding I experienced menstrual like cramps and minor lower back aches. Later during the day the cramps star... Read more
I experienced menstrual like cramps and minor lower back aches. Later during the day the cramps started to calm down, At nighttime I experienced flu like symptoms, I started to feel a sore throat that was by my tonsils. I also had aches under my eyes The next day I still had a sore throat and I also experienced earaches. A couple days later the eye aching got worse. I also started to have sharp pains in my stomach. I also wasn't able to eat anything , when I did eat one snack I felt very stuffed. I experienced a minor headache. At night a couple days later I still had experienced some more stomach aches that became very painful. When I start going to the bathroom I saw some blood. Couple weeks later I felt a little bit better , I by chance pushed on my lower stomach area close by my pelvis and it felt very sore. After all this I felt better and gained my energy back. Then that's when I felt the stomach pains by my kidney again and the menstrual like cramps. Not until May did all of my cramps and pains come to a stop.
65 2021-06-08 palpitations 3/28/21: 3 days after the shot, started having extreme heart palpitations that was painful and kept ... Read more
3/28/21: 3 days after the shot, started having extreme heart palpitations that was painful and kept the patient up at night. Lasted for 3 days Shortly after the heart related adverse event, patient started experiencing pain in her side that would "come and go" for months until 6/6/21, when the pain did not go away but was so severe that she started becoming nauseous from it. Patient went to the hospital where they found a clot to her kidney that cut circulation, resulting in the loss of part of her kidney
65 2021-06-08 palpitations patient called to state that her heart was racing. She did not take her anxiety med earlier and she ... Read more
patient called to state that her heart was racing. She did not take her anxiety med earlier and she was very nervous at the time of the vaccine. After a few hours she was still having the racing heart . I told her to reach out to her physician. I just wanted to make sure she was safe.
65 2021-06-09 atrial fibrillation AFIB
65 2021-06-10 blood clot in the brain I started to get a rash around the injection area and a stiff neck. Both resolved after about 5 days... Read more
I started to get a rash around the injection area and a stiff neck. Both resolved after about 5 days. On the 29th, I couldn't see after I got out of the shower. I went to the hospital and they gave me the TPA drug. I told them I had the vaccine and they said they weren't sure if it could be the cause. I was hospitalized for 3 days. Doctor thought it was a Cerebellum Stroke in the back of my head and think the drug broke up the clot. My vision did return after the drug. They didn't have any ICU beds and weren't equipped to handle my case, so they did telemed appt with Neurological ICU, where they did more testing. I have to follow up with their stroke clinic next week. They put me on new meds, to include Norvas, baby aspirin and Crestor.
65 2021-06-10 pulmonary embolism BILATERAL PE
65 2021-06-12 anaemia hot flashes, dull headaches, severe and unusual belly bloating, anemia
65 2021-06-12 heart rate increased 24 hr after shot my eyes, mouth swelled up. 48 hr after shot my throat began to swell shut, Called ... Read more
24 hr after shot my eyes, mouth swelled up. 48 hr after shot my throat began to swell shut, Called 911, ambulance, ER. IV drugs to reduce swelling from severe allergic rxn. Came home. Resting heart rate 100 bpm (vs 59 bpm normally) for next 8 days, with extreme fatigue, no appetite, loose stool, bedridden and needed help. Periods of elevated resting heartrate and extreme fatigue for next 3 weeks, so, 4 weeks total.
65 2021-06-14 chest pain Shortly after 1st Moderna shot on Mar 2 2021 I had what I thought was an asthma exacerbation. When b... Read more
Shortly after 1st Moderna shot on Mar 2 2021 I had what I thought was an asthma exacerbation. When breathing did not improve with previously prescribed rescue inhaler and daily oral medication, I saw my primary on Mar 26, 2021. My primary gave me a nebulizer treatment, prescribed a z-pack and renewed my Albuteral rescue inhaler. I got no relief from those interventions. On Mar 30, 2021 I had my 2nd Moderna vaccination. I walk daily, usually fast paced with moderate-high exertion, but while having difficulty breathing I walked slowly with light exertion. On Apr 2nd I was on my walk, short of breath, when I experienced pain in my left chest which moved into my left arm. My left arm was tingling then numb. I stopped and rested until the pain went away, maybe 3-4 minutes. I continued walking back to the car. My arm remained tingling and numb during that time and for about 30 minutes. I never felt the same level of pain that I did on April 2nd, but I continued to have shortness of breath, felt twinges/pinches and sometime a quick stab in my left chest. I also had some tightness/pressure in my left neck/throat. My blood pressure was also higher than normal for me. I have had a couple of asthma attacks in my life, but my asthma has been well-controlled and any breathing issues were always able to be resolved with my acute inhaler and a Nebulizer treatment. I had never had chest pain. I saw my primary at a first available appointment who set me up with appointments for pulmonary and cardiology. During this period I also was prescribed additional medications; 1 baby aspirin/day; Symbicort; Metoprolol; nitro (if needed for chest pain). My breathing got worse with the Metoproplol after 5 days and I was given Amlodipine instead. My breathing got easier with the change in medication. I found that lying down on my side helped my breathing. I have not been wakened by not being able to breathe during sleep and feel good first thing in the morning. Once I start moving around in the morning I feel shortness of breath during normal activity. Some days are improved, some days aren't as good. I have been avoiding even moderate exertion so I don't know if I would have chest pain like I experienced on Apr 2nd again. In addition to the shortness of breath I still feel a twinge/pinch in my left chest and a tightness/pressure on my left neck/throat area. My cardio cath Left/Right was performed Jun 14, 2021. There was no sign of any issues with my heart and no sign of pulmonary hypertension. As of this submission on Jun 15, 2021, I am grateful that there are no problems or concerns with my heart or lungs. I'll follow my doctor's orders to increase exercise and will have a Pulmonary Function Test in July. I was a person who went from being able to walk 3 miles at a fast pace with 100 foot elevation changes within 1/4 mile to having difficulty walking from my kitchen to the bathroom in a matter of weeks. The only anomaly in that time frame was my 2 Moderna vaccine shots. I'm submitting this because I feel you should know and because I am concerned with what I should do if a booster is required in the future.
65 2021-06-14 ejection fraction decreased, cardiac failure congestive Moderna shots given at a vaccine facility on 2/6/21 and 3/10/21. She has had a gradual onset of shor... Read more
Moderna shots given at a vaccine facility on 2/6/21 and 3/10/21. She has had a gradual onset of shortness of breath. Seen by me on June 1. Dx cardiomyopathy, Class 3 CHF. Hospitalized at local Medical Center. Currently still being treated by cardiology team.
65 2021-06-14 loss of consciousness she can't get up without passing out; chills; Nausea; Fever; This spontaneous case was reported by a... Read more
she can't get up without passing out; chills; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she can't get up without passing out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 057G120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (she can't get up without passing out) (seriousness criterion medically significant), CHILLS (chills), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, LOSS OF CONSCIOUSNESS (she can't get up without passing out), CHILLS (chills), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
65 2021-06-14 palpitations Right after the shot Immediate injection site burning, right arm began to itch really bad, had hives... Read more
Right after the shot Immediate injection site burning, right arm began to itch really bad, had hives on her hand, lips and face was very numb and tingle, throat tighten really badly, and heart would not stop racing. As of today 06/15/2021 the tingling in her body is horrible and the twiching is so bad that she cant even drink her water, her energy is very low and she can barely do what she used to do, is still very tired, numbing in her toes and her finger, and also is very dizzy all the time.
65 2021-06-15 hypertension Dehydration; High blood pressure; Fever 98.1 degrees fahrenheit); This spontaneous case was reported... Read more
Dehydration; High blood pressure; Fever 98.1 degrees fahrenheit); This spontaneous case was reported by an other caregiver and describes the occurrence of DEHYDRATION (Dehydration) and HYPERTENSION (High blood pressure) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMIN D NOS for an unknown indication. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced DEHYDRATION (Dehydration) (seriousness criterion hospitalization prolonged) and HYPERTENSION (High blood pressure) (seriousness criterion hospitalization prolonged). On 01-Jun-2021, the patient experienced PYREXIA (Fever 98.1 degrees fahrenheit) ). The patient was hospitalized for 3 days due to DEHYDRATION and HYPERTENSION. The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 tablet. At the time of the report, DEHYDRATION (Dehydration), HYPERTENSION (High blood pressure) and PYREXIA (Fever 98.1 degrees fahrenheit) ) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment received while hospitalized was not reported. Company comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
65 2021-06-18 inflammation of the pericardium Pericarditis Went to the emergency room April 18 miss- diagnosed for phenmonia treated w ant biotics... Read more
Pericarditis Went to the emergency room April 18 miss- diagnosed for phenmonia treated w ant biotics Returned to emergency room April 25 admitted April 25- 28 diagnosed pericarditis
65 2021-06-21 chest pain depression and anxiety, burning in chest, extreme fatigue, sleep issues, intense musculoskeletal pai... Read more
depression and anxiety, burning in chest, extreme fatigue, sleep issues, intense musculoskeletal pain only at site of previous injury/surgery. ALL symptoms lasted for about 10 weeks.
65 2021-06-21 heart rate increased I had a rapid heart beat.
65 2021-06-22 heart rate increased Not getting 2nd dose; Left breast is swollen; Shortness of breath; Loss of smell; Loss of taste; Los... Read more
Not getting 2nd dose; Left breast is swollen; Shortness of breath; Loss of smell; Loss of taste; Lost a lot of weight; diarrhea; She can't lift arm, can't do all the things she used to be able to do; Left breast is very painful; She is afraid; Swollen lymph of nodes; Muscle fatigue; Lump at injection site; heart beats quickly; Headache every night; Feels like she is wasting away; This spontaneous case was reported by a consumer and describes the occurrence of CACHEXIA (Feels like she is wasting away) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced CACHEXIA (Feels like she is wasting away) (seriousness criterion medically significant), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful), FEAR (She is afraid), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), INJECTION SITE MASS (Lump at injection site), HEART RATE INCREASED (heart beats quickly), and HEADACHE (Headache every night). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 UNK. At the time of the report, CACHEXIA (Feels like she is wasting away), BREAST SWELLING (Left breast is swollen), DYSPNOEA (Shortness of breath), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), WEIGHT DECREASED (Lost a lot of weight), DIARRHOEA (diarrhea), MOBILITY DECREASED (She can't lift arm, can't do all the things she used to be able to do), BREAST PAIN (Left breast is very painful), LYMPHADENOPATHY (Swollen lymph of nodes), MUSCLE FATIGUE (Muscle fatigue), HEART RATE INCREASED (heart beats quickly), INJECTION SITE MASS (Lump at injection site) and HEADACHE (Headache every night) had not resolved and FEAR (She is afraid) and PRODUCT DOSE OMISSION ISSUE (Not getting 2nd dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Heart rate: increased (Inconclusive) heart beats quickly. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
65 2021-06-22 hypertension HIVES, RASH UPPER BACK, SHINGLES, COVID ARM SORENESS AT INJECTION SITE, SWELLING, EXTREME FATIGUE, D... Read more
HIVES, RASH UPPER BACK, SHINGLES, COVID ARM SORENESS AT INJECTION SITE, SWELLING, EXTREME FATIGUE, DIARRHEA, SEVERE CONSTIPATION, EXTREME OR SEVER JOINT PAIN, HIGH BLOOD PRESSURE. RINGING IN INNER EARS, INSOMNIA FREQUENT URINATION, BLURRY VISION, GUM SORENESS, PRE DIABETES.
65 2021-06-23 cerebrovascular accident I had a stroke on April 15th. The day after the vaccine, I had a bad headache and chills.
65 2021-06-28 chest discomfort Cramping and numbness in legs and feet, tightness in chest
65 2021-06-29 heart failure Shortness of breath leading to heart failure.
65 2021-07-01 chest pain Patient states 10 minutes after receiving her second, she started experiencing nausea, chest pain, l... Read more
Patient states 10 minutes after receiving her second, she started experiencing nausea, chest pain, light headedness. Patient was still in shot clinic facility waiting in observation. A nurse practitioner evaluated her and suspicious of atrial fibrillation, was directed to Medical Center ER via ambulance. Her PCP was notified by phone and he recommended same course of action. She was evaluated at the ER and patient states they didn't find anything wrong. Patient states that her PCP was already concerned about atrial fibrillation diagnosis and had referred her to cardiologist, but she has not had an eval yet in regards to atrial fibrillation.
65 2021-07-02 chest discomfort EXTREME FATIGUE. Prior to this date, I was extremely active. I have never felt this type of fatig... Read more
EXTREME FATIGUE. Prior to this date, I was extremely active. I have never felt this type of fatigue. I have always been very active, I was able to hike elevation of 1000ft, 5-7 miles, advanced yoga, run on treadmill, etc. Since 1 month after the second shot I had experience extreme fatigue with chest pressure and sometime hard to get air. The fatigue lasted 12 weeks, improving slowly. To date of this form, I will have an occasional relapse of fatigue that will come on. I am back to yoga (very beginner level). I am slowly gaining strength but there is nothing else to explain this. Nothing has been different in my life but for receiving the Covid vaccine.
65 2021-07-05 deep vein blood clot, pulmonary embolism DVT LEFT LEG AND PULMONAEY EMBOLISM SHORTNESS OF BREATH ABOUT 6 WEEKS AFTER 2ND DOSE
65 2021-07-05 fainting, blood pressure fluctuation Feeling of sudden faint; Chronic fatigue for 10 weeks; Felt shaky inside; Blood pressure was up and ... Read more
Feeling of sudden faint; Chronic fatigue for 10 weeks; Felt shaky inside; Blood pressure was up and down; Felt like bad flu bug; Lightheadedness; Weakness; Felt crappy; Lots of night sweats; Chills during the day; Nausea; Fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Feeling of sudden faint) and FATIGUE (Chronic fatigue for 10 weeks) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Migraine and Bladder disorder. Concomitant products included MIRABEGRON (MYRBETRIQ) for Bladder disorder, GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) and ELETRIPTAN HYDROBROMIDE (RELPAX) for Migraine, CICLOSPORIN (RESTASIS), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and ESTRADIOL (ESTRACE) for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Feeling of sudden faint) (seriousness criterion medically significant), FATIGUE (Chronic fatigue for 10 weeks) (seriousness criterion medically significant), NERVOUSNESS (Felt shaky inside), BLOOD PRESSURE FLUCTUATION (Blood pressure was up and down), INFLUENZA LIKE ILLNESS (Felt like bad flu bug), DIZZINESS (Lightheadedness), ASTHENIA (Weakness), VACCINATION COMPLICATION (Felt crappy), NIGHT SWEATS (Lots of night sweats), CHILLS (Chills during the day), NAUSEA (Nausea) and PYREXIA (Fever after 2nd dose). At the time of the report, SYNCOPE (Feeling of sudden faint), FATIGUE (Chronic fatigue for 10 weeks), NERVOUSNESS (Felt shaky inside), BLOOD PRESSURE FLUCTUATION (Blood pressure was up and down), INFLUENZA LIKE ILLNESS (Felt like bad flu bug), DIZZINESS (Lightheadedness), ASTHENIA (Weakness), VACCINATION COMPLICATION (Felt crappy), NIGHT SWEATS (Lots of night sweats), CHILLS (Chills during the day), NAUSEA (Nausea) and PYREXIA (Fever after 2nd dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 09-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Blood pressure measurement: up and down (Inconclusive) up and down. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient stated that she had side effects several weeks after the vaccine and from the vaccine and stated that she does not want to get a booster. Side effects experienced by the patient was fever after 2nd dose for 2 nights, chills then was fine but on 07-Apr-2021, felt very tired after a trip as she flew on the plane but never got better after that. She stated that she had chronic fatigue for 10 weeks, nausea, lightheadedness and still has it, lost 5 pounds in weight, felt shaky inside at times that felt like too much caffeine was taken, lots of night sweats, chills during the day and felt like bad flu bug and after 3 weeks of that, she went to her primary care provider. Patient reported feeling crappy. She was then referred to an infectious disease specialist who did more blood work and everything was normal. The patient went Ear nose throat (ENT) specialist as she was having dizziness. Patient also reported experiencing fatigue and very weak and she had an episode of feeling of sudden faint and weakness that only happened one time. Her doctor told her it was not due to Corona virus disease (COVID) as she developed antibodies. Treatment medication not provided. The action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
65 2021-07-07 heart rate increased Notes: The Frequency, Duration and Intensity of all my preexisting symptoms, plus 9 new symptoms, i... Read more
Notes: The Frequency, Duration and Intensity of all my preexisting symptoms, plus 9 new symptoms, increased exponentially on the 3rd day after I received the 2nd Moderna coronavirus vaccination on March 31, 2021. For five weeks the symptoms were every day; now they wax and wane randomly every 2-3 days. The symptoms present randomly (i.e. not in the constellation of symptoms I would normally get with an MCAS flareup), which initially was confusing and disorienting. It feels as though something got turned on in my brain and hasn't turned off. This has seriously and detrimentally affected my quality of life. I now carry a medical Alert device because I have fallen due to the disequilibrium. Symptoms listed in alphabetical order: Items marked with @ are new, never before experienced symptoms. ? Anxiety ? @ Breathing, sometimes dysregulated ? Brain fog ? @ Cognitive: Word finding, rambling, losing track of conversations. 1st shot during acute phase; 2nd shot acute phase then continuing intermittently ? @ Delirium: ? Symptoms: ? Confusion: 1 Day ? @ Emotions, Heightened, sudden onset with no provocation ? @ Hallucinations, Auditory: 1/2 day ? Lightheaded: 1 day. Only during acute phase of delirium (feeling disconnected) ? Onset: Began with heightened emotions (anger, fear, crying/tearful, depression, joy) late afternoon. The next morning auditory hallucinations, disequilibrium, and confusion; insomnia (slept 2:30-8:30am and intense anger the night before followed by fear then paranoia. The acute phase ended as suddenly as it began about 10:00am - total acute episode lasted about 12 hours. However the heightened emotional state - anger, fear, paranoia, - continued. My handwriting was large, loopy for 2 days. ? Complication: followed by fear of repetition, concern because cause unknown, and anxiety dreaming for 2 weeks ? History: I had disequilibrium, confusion and cognitive symptoms in combination only once before, when I had the flu in 2019; duration 1 day ? Disequilibrium ? Emotionally labile, random: tearful, sad, depressed, scared. Began with delirium but has continued intermittently with flare-ups ? Fingers, Icy cold: began during acute phase on same day as delirium, and lasted 4 weeks; continues wit cold fingers during intermittent flare-ups ? @ Heart rate, resting, rapid - 10-14 beats above normal for 2 weeks ? Incontinence and urgency: urinary and gastro ? Senses Heightened or changed: ? Light (photophobia) and Sound (hyperacusis) sensitive ? @ Smell heightened (hyperosmia) ? Taste, Metallic ? Sexual arousal, low level, random and unexpected: briefly for a few minutes several times during acute phase; a few times during intermittent flare-ups ? Sleep, disrupted: Insomnia and Insufficient ? @ Swallowing, difficulty: suddenly unable to swallow water (it got 'stuck') usually on days I have dysregulated breathing ? Tinnitus, increased exponentially: Volume, Duration and Spiking; began fter 1st shot and became even worse after the 2nd shot. I have not yet returned to baseline ? @ Tremors, hands and arms: after mild exertion and/or fine work such as sewing or using mouse to edit photos. ? Vision: Blurred, Diplopia (I have Adie's Tonic Pupil): Increases during acute phase; intermittent with flareups. Other: ? Sudden onset Sinus Congestion, edema, itching and sneezing 12 hours after 1st and 2nd shots and lasted about 4-5 days. ? Fatigue, edema, joint pain, muscle pain, Rosacea flare, canker sores flare all continuing during flareups. ? To reiterate: Symptoms became exponentially heightened in Frequency, Intensity and Duration, and occur randomly - not in the constellation that I'm used for MCAS or Dysautonomia or Tinnitus.
65 2021-07-08 blood pressure fluctuation hypertensive crisis; running a fever for the past four weeks (temperature > 100); headache/felt like... Read more
hypertensive crisis; running a fever for the past four weeks (temperature > 100); headache/felt like her head would explode; nausea; gained 20 lbs.; This spontaneous case was reported by a nurse and describes the occurrence of HYPERTENSIVE CRISIS (hypertensive crisis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Atrial fibrillation, Arrhythmia, Cardiomyopathy, Heart failure, Lymphoma (2-3 years ago), Clot blood in 2018, Cardiac resynchronization therapy in 2018, Defibrillator/pacemaker insertion in 2018 and Cardiac catheterisation in 2018. Concomitant products included PROPAFENONE (RYTHMOL), ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID), LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), BUMETANIDE (BUMEX), POTASSIUM and MAGNESIUM for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced WEIGHT INCREASED (gained 20 lbs.). On 18-May-2021, the patient experienced HYPERTENSIVE CRISIS (hypertensive crisis) (seriousness criteria hospitalization and medically significant). On 30-Jun-2021, the patient experienced HEADACHE (headache/felt like her head would explode) and NAUSEA (nausea). On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (running a fever for the past four weeks (temperature > 100)). The patient was treated with ATENOLOL (TENORMIN) ongoing since an unknown date at a dose of 200 mg; LORAZEPAM (ATIVAN) ongoing since an unknown date at a dose of 1 mg every other day; SPIRONOLACTONE at a dose of 25 mg twice a day and AMLODIPINE at a dose of 5 mg twice a day. At the time of the report, HYPERTENSIVE CRISIS (hypertensive crisis), BODY TEMPERATURE INCREASED (running a fever for the past four weeks (temperature > 100)), WEIGHT INCREASED (gained 20 lbs.), HEADACHE (headache/felt like her head would explode) and NAUSEA (nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jun-2021, Blood electrolytes decreased: low (Low) Low. On 30-Jun-2021, Blood pressure fluctuation: 254/140 (High) 254/140. On 30-Jun-2021, Inflammatory marker increased: high (High) High. On 30-Jun-2021, Monocyte count increased: high (High) High. On an unknown date, Blood pressure fluctuation: 290/145 290/145. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient had been running a fever for the past four weeks. The patient electrolytes was below normal, her monocytes was high, and inflammation markers was all high. The patient had been hospitalized four or five times since 10/Apr/2021. The patient had to go to the Emergency Room yesterday (30Jun2021) as her blood pressure elevated to 254/140. In addition the patient was experiencing a headache, and nausea and reported that it felt like her head would explode. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-244633 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
65 2021-07-08 haemoglobin decreased Pt had mild Gi illness diarrhea and vomiting for 2 days, then was not producing urine. Found to be i... Read more
Pt had mild Gi illness diarrhea and vomiting for 2 days, then was not producing urine. Found to be in kidney failure. Had to start hemodialysis
65 2021-07-08 heart rate increased I had COVID arm eight days after my first vaccine. I still had COVID arm when I received my second v... Read more
I had COVID arm eight days after my first vaccine. I still had COVID arm when I received my second vaccine, on my right arm. About 8-9 days later I broke out in a rash. In the middle of might, burning and itching on my arm, seemed I developed auto-immune disorder, I also developed a skin liken sclerosis, never had that before, think it is related to the T-cells. on my neck. At the same time, I developed two different symptoms, liken sclerosis which I have never had before and also my breaking out in rash on my neck and it is right above my thyroidectomy scar. I have this redness around my neck and have not been on the sun. I still have the rash and still dealing with the COVID arm. I also experienced a fever and had rapid heartbeats. My T-cells went crazy and I am concerned what is going on with me. I also have some auto immune disease. I still have the rash and still dealing with the COVID arm.
65 2021-07-11 chest pain Pain in the left side of my chest
65 2021-07-12 palpitations Heart palpitations and fatigue after 1st injection in March. Increase in frequency in May, after the... Read more
Heart palpitations and fatigue after 1st injection in March. Increase in frequency in May, after the 2nd injection.
65 2021-07-13 heart rate increased Eight minutes after shot, a flush of heat went up my body and my face turned very red. My heart rat... Read more
Eight minutes after shot, a flush of heat went up my body and my face turned very red. My heart rate felt very rapid. I alerted the monitor person and was taken to the ER. They determined the hives/redness was all over my torso and gave me a shot of Benadryl. I was monitored for two hours and released. I had a couple more incidences of hives over the next several hours, but not as bad as the first time. I didn't go for any more treatment.
65 2021-07-13 loss of consciousness PATIENT LEFT AFTER WAITING IN STORE FOR 15 MINUTES..SHE DROVE HOME AND WHEN SHE TRIED TO GET OUT OF ... Read more
PATIENT LEFT AFTER WAITING IN STORE FOR 15 MINUTES..SHE DROVE HOME AND WHEN SHE TRIED TO GET OUT OF CAR SHE FELT WOOZY. SHE TRIED TO HOLD ONTO HER CAR AND BLACKED OUT. A NEIGHBOR SAW HER AND CALLED 911. PATIENT WENT TO HOSPITAL AND HAD A PACE MAKER PLACED IN AND ALSO SURGERY FOR HER BROKEN ANKLE THAT SHE INCURRED WHILE TRYING TO GET UP AT HOME. SHE WAS IN HOSPITAL FOR 30 DAYS AND HAS BEEN RELEASED.
65 2021-07-17 chest discomfort Chest tightness; After two to three weeks later still dizzy; Groin pain; Tired un able to get up; Vo... Read more
Chest tightness; After two to three weeks later still dizzy; Groin pain; Tired un able to get up; Vomiting; Vertigo; couldn't get out of bed/ couldn't move; shakes really bad; Sore throat; Urinary tract infection; Yeast infection; Bladder not in control/ Difficulty in holding urine; other arm hurt more than the arm i got shot in, vaccination site pain; Headache; Fever; Chills; Pain and Myalgia; Coughing; Bladder pain; Bladder always feels bloated; Sensation of throat closing; Nausea/vomiting; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection), FUNGAL INFECTION (Yeast infection) and URINARY INCONTINENCE (Bladder not in control/ Difficulty in holding urine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B212A and 040B27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Sensation of throat closing), BLADDER DISCOMFORT (Bladder always feels bloated) and BLADDER PAIN (Bladder pain). 14-May-2021, the patient experienced NAUSEA (Nausea/vomiting). On 15-May-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion medically significant), FUNGAL INFECTION (Yeast infection) (seriousness criterion medically significant), URINARY INCONTINENCE (Bladder not in control/ Difficulty in holding urine) (seriousness criterion medically significant), MALAISE (couldn't get out of bed/ couldn't move), TREMOR (shakes really bad), OROPHARYNGEAL PAIN (Sore throat), PAIN (Pain and Myalgia), COUGH (Coughing), VACCINATION SITE PAIN (other arm hurt more than the arm i got shot in, vaccination site pain), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 20-Jun-2021, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest tightness), DIZZINESS (After two to three weeks later still dizzy), GROIN PAIN (Groin pain), FATIGUE (Tired un able to get up) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at a dose of 1 dosage form. On 17-May-2021, MALAISE (couldn't get out of bed/ couldn't move), TREMOR (shakes really bad), OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE PAIN (other arm hurt more than the arm i got shot in, vaccination site pain), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) had resolved. On 28-May-2021, URINARY INCONTINENCE (Bladder not in control/ Difficulty in holding urine) had resolved. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) and FUNGAL INFECTION (Yeast infection) had resolved, VERTIGO (Vertigo), CHEST DISCOMFORT (Chest tightness), OROPHARYNGEAL DISCOMFORT (Sensation of throat closing), DIZZINESS (After two to three weeks later still dizzy), PAIN (Pain and Myalgia), BLADDER DISCOMFORT (Bladder always feels bloated), BLADDER PAIN (Bladder pain), GROIN PAIN (Groin pain), FATIGUE (Tired un able to get up), NAUSEA (Nausea/vomiting) and VOMITING (Vomiting) outcome was unknown and COUGH (Coughing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Body temperature: 101.6 (High) Fever 101.6. On 19-May-2021, Urine analysis: abnormal (abnormal) UTI-Yeast infection.. On an unknown date, Body temperature: 101.9 (High) 101.9. Concomitant product was not reported. Reporter was provided treatment information that include 7 day course of antibiotics, yeast infection medicine, over the counter yeast infection medicine and vertigo medication. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-231189 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received and added new events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
65 2021-07-17 chest pain Severe rash, headache, chest pain, shortness of breath, irritability, disoriented
65 2021-07-18 hypertension, heart rate irregular, chest pain Pt. states after receiving the Moderna 1st shot 12/31/2020, started experiencing 01/03/2021 symptoms... Read more
Pt. states after receiving the Moderna 1st shot 12/31/2020, started experiencing 01/03/2021 symptoms achey, confusion, nauseous, severe left-sided chest pain (up the left side to neck), headache, irregular heart beat, HBP, Follow-Up with Cardiologist, swelling of the face, exhaustion every 10 to 12 days. ER 01/03/2021
65 2021-07-19 platelet count decreased, low platelet count Patient presents after falling in her shower. She has been having dark stools for a couple weeks and... Read more
Patient presents after falling in her shower. She has been having dark stools for a couple weeks and weakness and dizziness for a couple days. In the emergency room, she was found to have macrocytic anemia and thrombocytopenia. Treatments patient has received include steroids, rituximab, and eltrombopag
65 2021-07-24 heart rate irregular, palpitations Irregular heart beat, heart palpitations, weakness, dizziness. Had two episodes that lasted 1 hour. ... Read more
Irregular heart beat, heart palpitations, weakness, dizziness. Had two episodes that lasted 1 hour. No treatment, went to bed. Still feel off, not normal. Other symptoms were the normal ones-fever, chills, sweating, extreme achiness. By the 3rd day had the adverse events. Continue to feel weak and tired, and like heart is racing if I do too much.
65 2021-07-26 heart attack Patient presented to the ED and was subsequently hospitalized for NSTEMI within 6 weeks of receiving... Read more
Patient presented to the ED and was subsequently hospitalized for NSTEMI within 6 weeks of receiving COVID vaccination.
65 2021-07-27 chest discomfort, heart rate irregular After 20 minutes face and neck bright red, heartbeat flippy, intchy throat tight lungs, colon comple... Read more
After 20 minutes face and neck bright red, heartbeat flippy, intchy throat tight lungs, colon completely evacuated.
66 2021-01-01 heart rate increased, blood pressure increased Elevated blood pressure and heart rate. 163/116 HR 125. I got up at 9:00 am with elevated BP and HR.... Read more
Elevated blood pressure and heart rate. 163/116 HR 125. I got up at 9:00 am with elevated BP and HR. I had missed a dose of Metoprolol the previous evening. I felt shaky/jittery and checked my BP and HR. Called the doctor on call at my PCP's office and he stated it is probably rebound hypertension and elevated HR due to missing the dose of Metoprolol last night. His direction was to check in two hours, and if still elevated, take 1/2 tablet Metoprolol. Current readings at 2:00 pm are 129/97 HR 99. Unsure if related to Covid vaccine. MD recommended reporting to CDC
66 2021-01-01 heart rate increased Severe dizziness to the point I was unable to walk or even sit without fear of passing out or fallin... Read more
Severe dizziness to the point I was unable to walk or even sit without fear of passing out or falling and had to lay on the floor. Rapid heart rate, nausea, felt like blood pressure was going up a lot. Afraid I was on the verge of having a stroke. Symptoms hit abruptly with no warning. Were severe for about an hour and then started subsiding. Gradually felt better over the course of a couple of hours. After about 6 hours, symptoms completely gone and I felt fine.
66 2021-01-01 lightheadedness Patient had transient vasovagal response after the injection with light head feeling and tinnitus. R... Read more
Patient had transient vasovagal response after the injection with light head feeling and tinnitus. Resolved within 30 minutes. Normal vital signs.
66 2021-01-01 cardiac arrhythmia PVCs about 45 minutes after injection. Although I have had them before, it?s been at least a month s... Read more
PVCs about 45 minutes after injection. Although I have had them before, it?s been at least a month since they have occurred. They don?t usually happen in the morning without any activity. Also felt a bit weak later in the day but not sure this was from vaccine. I was fine the next day.
66 2021-01-05 heart rate increased HR usually in 80s (via watch). Increased to 109.. Felt Anxious. Placed in a wheelchair for patien... Read more
HR usually in 80s (via watch). Increased to 109.. Felt Anxious. Placed in a wheelchair for patient safety and rolled to a private area for monitoring. Blood pressure checked 166/76. Gave water and nutragrain bar. HR decreased back to 80s within 5 minutes and anxiety resolved. Patient is a dietician. However she did not eat breakfast this AM. Also stated she gets anxious with shots.
66 2021-01-06 blood pressure increased At 8:30 pm , sudden increase in Blood pressure 192/90 , pulse rate at 108 Palpitation Lasted for 3... Read more
At 8:30 pm , sudden increase in Blood pressure 192/90 , pulse rate at 108 Palpitation Lasted for 30-45 min then gradual decline to normal at 130/80 Laid in bed & drinking water
66 2021-01-06 palpitations While waiting 15 minutes after the injection, I begin to feel my heart bounding. I checked my heart ... Read more
While waiting 15 minutes after the injection, I begin to feel my heart bounding. I checked my heart rate on my Apple watch, it was 165. The heart rate slowly came down to the 120's after approximately 30 seconds and remained their for thirty minutes. I felt better and left the vaccination location. Shortly after, while driving home my heartrate went up to 152 for approximately the same amount of time so I drove to my doctors office and explained what happen. They told me to go to the emergency room. By then my heartrate was 109 and I was feeling better. I did not feel the need to go to the emergency room, which I live less than a mile from the nearest hospital. Eventually my heartrate settled at 70-80's nearly 4 hours after the event.
66 2021-01-07 chest discomfort Pt reported a flushing feeling, then tightness in her chest; given 50 mg of diphenhydramine, then 0.... Read more
Pt reported a flushing feeling, then tightness in her chest; given 50 mg of diphenhydramine, then 0.3 mg of epinephrine IM. Pt's symptoms resolved. No further incidents
66 2021-01-07 heart rate increased 12-23-2020 Fever, chills, increased heart rate night of her injection
66 2021-01-07 hypertension Had Moderna vaccine on Dec, 30, 2020. starting 1/5/202 feeling lightheaded, blood pressure high, chi... Read more
Had Moderna vaccine on Dec, 30, 2020. starting 1/5/202 feeling lightheaded, blood pressure high, chills off and on, no fever, redness at the site of the shot.
66 2021-01-07 fainting Patient felt dizzy and experienced syncope. Left leg felt weaker than normal. Lactated ringers and m... Read more
Patient felt dizzy and experienced syncope. Left leg felt weaker than normal. Lactated ringers and meclizine 25 mg PO once provided in the emergency department. Patient was discharged from the emergency department.
66 2021-01-09 cardiac failure congestive 1/9/2021 fever of 101.3, chills, 1/10/2021 fever 99.6, diarrhea, pain in injection site slight. Ty... Read more
1/9/2021 fever of 101.3, chills, 1/10/2021 fever 99.6, diarrhea, pain in injection site slight. Tylenol
66 2021-01-12 oxygen saturation decreased Presented to MD'S office on 01/05/2021 with cough, HA, fever 101.9, chills, and fatigue. Returned ... Read more
Presented to MD'S office on 01/05/2021 with cough, HA, fever 101.9, chills, and fatigue. Returned on 01/07/2021 with no improvement. Returned on 01/11/2021 with fatigue, elevated temp 101.2, SOB, 02 Sat at 90%, Rocephin 1G IM administered, CXR revealed pneumonia. MD received call from patients husband stating worsening 02 Sat levels at 81-82%. Was transferred to hospital and admitted with pneumonia..
66 2021-01-12 palpitations Patient presents to ED on 1/12/21 with Allergic Reaction (pt received Moderna Covid-19 vaccine at ho... Read more
Patient presents to ED on 1/12/21 with Allergic Reaction (pt received Moderna Covid-19 vaccine at hospital, and pt states about 10 minutes later she started to feel dizzy, sob, heart racing, and developed rash on hands and chest.) Pt seen by Dr. Pt was ordered NS 500 mL IV x1, diphenhydramine 25 mg IV x1, famotidine 20 mg IV x1, methylprednisolone 125 mg IV x1, and ondansetron 4 mg IV x1. Symptoms resolved prior to discharge from ED. She was given scripts for diphenhydramine and prednisone with instructions to follow up with PCP.
66 2021-01-12 palpitations Patient presents to ED on 1/12/21 with Allergic Reaction (pt received Moderna Covid-19 vaccine at S... Read more
Patient presents to ED on 1/12/21 with Allergic Reaction (pt received Moderna Covid-19 vaccine at SCH, and pt states about 10 minutes later she started to feel dizzy, sob, heart racing, and developed rash on hands and chest. ) Pt seen by Dr Pt was ordered NS 500 mL IV x1, diphenhydramine 25 mg IV x1, famotidine 20 mg IV x1, methylprednisolone 125 mg IV x1, and ondansetron 4 mg IV x1. Symptoms resolved prior to discharge from ED on 1/12/21. She was given scripts for diphenhydramine and prednisone with instructions to follow up with PCP.
66 2021-01-12 palpitations Patient presents to ED on 1/12/21 with Allergic Reaction (pt received Moderna Covid-19 vaccine , and... Read more
Patient presents to ED on 1/12/21 with Allergic Reaction (pt received Moderna Covid-19 vaccine , and pt states about 10 minutes later she started to feel dizzy, sob, heart racing, and developed rash on hands and chest. ) Pt seen by Dr . Pt was ordered NS 500 mL IV x1, diphenhydramine 25 mg IV x1, famotidine 20 mg IV x1, methylprednisolone 125 mg IV x1, and ondansetron 4 mg IV x1. Symptoms resolved prior to discharge from ED on 1/12/21. She was given scripts for diphenhydramine and prednisone with instructions to follow up with PCP.
66 2021-01-14 chest pain HEADACHE, EXTREME FATIGUE, SORE THROAT, RUNNY NOSE, CHEST PAIN, COUGHING, CONGESTION, WHEEZING..
66 2021-01-14 low blood oxigenation Initially started as shortness of breath followed by fevers, aches, muscle cramps. Ultimately ended... Read more
Initially started as shortness of breath followed by fevers, aches, muscle cramps. Ultimately ended up in the hospital with hypoxemia, pleural effusions. Laboratory values showed evidence of acute renal insufficiency, eosinophilia. Physical exam consistent with pulmonary edema and lower extremity macular rash. Entire presentation concerning for DRESS syndrome
66 2021-01-16 heart rate increased While driving home after leaving facility 15 minutes after shot, I started having an increased heart... Read more
While driving home after leaving facility 15 minutes after shot, I started having an increased heart rate. Once home, the rapid heart rate continued and I noticed throat swallowing was getting a little tighter. I started drinking water and just breathed normally sitting down. I went to a mirror to see if I could see any swelling of my face and noticed my neck right under my chin was red about half way down. My chest seemed fine. I continued to just sit & drink water and soon the heart rate was getting back to normal. I noticed the redness on my neck was getting lighter also. I looked at my watch and it had been a little over an hour since my vaccination. I did not seek treatment, nor have I called my doctor. There have been no more adverse reactions.
66 2021-01-17 pallor Within 10 minutes of injection face and neck felt hot and became very flushed. Hands white and cold.... Read more
Within 10 minutes of injection face and neck felt hot and became very flushed. Hands white and cold. Within minute or two after that face, lips, tongue, and hands became numb and tingling. Felt weak all over basically. Lasted approximately 10-15 minutes.
66 2021-01-18 hypotension Shivers, trembling, vomiting, general weakness, low blood pressure and slight fever. slept for 1.5 d... Read more
Shivers, trembling, vomiting, general weakness, low blood pressure and slight fever. slept for 1.5 day Took three time my Hydrocortisone medication. Also took my BP medication and Tylenol.
66 2021-01-20 heart rate increased Immediate onset of dizziness and fast heart rate. (I did not report to Attendant because blamed it ... Read more
Immediate onset of dizziness and fast heart rate. (I did not report to Attendant because blamed it on feeling nervous.) Dizziness subsided before leaving at 2:42p. However, the fast heart rate was felt in evening hours before going to bed. I felt fine next morning w/o any side effects..
66 2021-01-21 low blood oxigenation Patient reported difficulty swallowing along with throat swelling. she became diaphoretic along with... Read more
Patient reported difficulty swallowing along with throat swelling. she became diaphoretic along with slight hypoxia to 93% requiring supplemental oxygen
66 2021-01-24 heart rate increased, hypertension Day of shot 1/22, shaking, flu like symptoms, accelerated heart rate, high blood pressure, body ache... Read more
Day of shot 1/22, shaking, flu like symptoms, accelerated heart rate, high blood pressure, body aches and headache.
66 2021-01-24 heart rate increased Exactly 10 hours after my shot both legs from my thigh to my toes I had severe cramps and cannot mov... Read more
Exactly 10 hours after my shot both legs from my thigh to my toes I had severe cramps and cannot move I couldn?t sit I couldn?t bend my legs to mute go up the steps at lasted for an hour broke out in sweats heart was racing finally subsided after an hour then all night I got little cramps on my toes or my calves
66 2021-01-24 palpitations I had severe cramping in both legs from my thigh to my toes I couldn?t bend I couldn?t sit I couldn?... Read more
I had severe cramping in both legs from my thigh to my toes I couldn?t bend I couldn?t sit I couldn?t even lift my leg to go up to the stairs I broke out of a sweat heart was racing and I had to shuffle my feet to walk around for about an hour then it subsided and then all night I kept getting little cramps in my legs
66 2021-01-24 lightheadedness, very slow heart rate 1350 - Vagal reaction to injection. Vitals taken 160/80 P63. 1400- Vitals 125/80 P57 O2 98% 1411 ... Read more
1350 - Vagal reaction to injection. Vitals taken 160/80 P63. 1400- Vitals 125/80 P57 O2 98% 1411 - Repeat vagal reaction. - EMS called to site. Pt was bradycardic - alert and never lost consciousness. History of syncope in past. Pt has been sating at 97%. O2 applied at 6L and pt is now sating at 100%. 1415- EMS arrived on scene, is present and evaluating patient. Pt continues to sat at 100%. 1420 Pt is refusing transport and signed AMA. Pt given instructions.
66 2021-01-25 heart rate increased Fast heart beats, recorded highest rate 119 per minute. It lasted for a week, with 3 - 4 occurrence... Read more
Fast heart beats, recorded highest rate 119 per minute. It lasted for a week, with 3 - 4 occurrences a day, usually happened in morning and evening, a couple of time around midnight. A little bit rash on the arms.
66 2021-01-25 loss of consciousness, loss of consciousness Patient states worst of side effects started about 11:20pm that night. Patient went to bed after get... Read more
Patient states worst of side effects started about 11:20pm that night. Patient went to bed after getting home about 8pm. Patient had pain that started in arm where she got shot, then hurt in right leg, and then left leg and arm. Patient passed out at one point, causing her to fall and hit head on bathroom floor. She did not seek any medical attention at that time and has not since her vaccine. She had extreme thirst from 8pm until 3am. She could not sleep due to pain. Patient was foggy after that for several days, but she is back at work today and feels much better. Patient doesn't think she had fever. She did have a lot of hot/cold flashes. Patient states she is entering information into the VAERS online system herself since she knows all her symptoms. Patient is wanting to speak to someone that knows about Mold toxicity and if it correlates to the covid Vaccine. She states she had the same symptoms when she had mold toxicity before. States she had a mold toxin dump at that time when she lived in Dallas and was given an IV which caused symptoms to stop. Patient states she will look up someone if she needs to and does not want the provider to do any leg work. She has several books and has ordered more. When this occurred before, she had hyperbaric oxygen therapy and believes this pushed toxins out of her cells into her body
66 2021-01-25 loss of consciousness, fainting 12 hours post vaccination - Rigors 22 hours post vaccination - Nausea, syncope, loss of consciousne... Read more
12 hours post vaccination - Rigors 22 hours post vaccination - Nausea, syncope, loss of consciousness for ~ 1 minute Treatment - Tylenol Observed by husband (physician)
66 2021-01-25 pulmonary embolism Patient was admitted to hospital for Pulmonary Embolism
66 2021-01-27 heart rate abnormal 5-6 minutes after vaccine I became light headed 5-6 minutes after vaccine a very bad! headache heart... Read more
5-6 minutes after vaccine I became light headed 5-6 minutes after vaccine a very bad! headache heart rate was recorded at 125-129 bpm on my Fitbit I returned to vaccine facility to have my BP checked and it was recorded at 150/85; 5-10 minutes later my BP was 136/xx. I returned to work.... bpm returned to normal within the next hour still having headache two hours after vaccine
66 2021-01-27 palpitations received the moderna vaccine @1638 pm pt c/o itchiness to her left forearm and hot flush @ 1700; mov... Read more
received the moderna vaccine @1638 pm pt c/o itchiness to her left forearm and hot flush @ 1700; moved to triage area and put on a gurney c/o tingling on her throat sensation, flushed look with continued itchiness on her left forearm given cetirizine @ 1707; given EpiPen 0.3 mg IM @1710 and called 911 @1710 started VS monitor and gave her 02 @1707 pt stabilized with tingling on her throat/redness on her cheek improved c/o palpitation and shakiness after EpiPen given paramedic arrived @1718 and took pt to ER for close monitoring
66 2021-01-29 heart rate increased Soreness at injection site, fever, extreme fatigue, dizziness, fast heart rate. 24 hour duration
66 2021-01-30 chest discomfort Twenty minutes after injection broke out in a sweat from head to toe. Vitals were only slightly ele... Read more
Twenty minutes after injection broke out in a sweat from head to toe. Vitals were only slightly elevated. Continued with bouts or waves of warmth for 2weeks. Also feel anxiety in my chest that continues
66 2021-01-30 chest pain, chest discomfort, hypertension, heart rate increased 67 year old female with PMH. Presented to site for Moderna vaccine 2nd dose, w/ no acute discern at... Read more
67 year old female with PMH. Presented to site for Moderna vaccine 2nd dose, w/ no acute discern at the time. Patient reported shortness of breath, chest pain/discomfort, High BP SP vaccine administered. GMS initiated ALS treatment. *Clinical Lead NOR Site Manager was notified until after the fact.* Initial examination on stretcher in back of ambulance - BP 210/106 --- blood sugar 120 ---- HR 146 At bedside in ER - BP 212/102 --- HR 126
66 2021-01-30 heart rate increased Muscle pain, joint pain, headache, rapid heartbeat. Took Tylenol. Day after vaccine.
66 2021-01-30 hypertension Swollen jaw and throat, difficulty swallowing, high blood pressure Treated with intravenous Benadryl... Read more
Swollen jaw and throat, difficulty swallowing, high blood pressure Treated with intravenous Benadryl on site Taken by ambulance to hospital where additional medication given Bloodwork, X-rays of lungs taken Monitored for 2 hrs and released to husband with epi-pen and prednisone prescription
66 2021-01-31 chest discomfort 8 mins after vaccine reported feeling dizzy, chest tightness and difficulty swallowing tight throat,... Read more
8 mins after vaccine reported feeling dizzy, chest tightness and difficulty swallowing tight throat, VSS 151/84,HR 83, O2sat 95%, Epinephrine administered 1000:1 @ 9:52 0.3ml, repeated at 10:27 due to no improvement of symptoms.Stablized at 11:11 with BP 128/88- HR 85,
66 2021-01-31 chest pain i noticed the 1st hr or 2 a burning through my shoulder and up into my neck and the top of my lungs ... Read more
i noticed the 1st hr or 2 a burning through my shoulder and up into my neck and the top of my lungs were burning but went away, then about 4 or 5 hrs in i began to fell really tired. i had muscle ache, chills up into 12 hrs i had muscle and joint ache, to get relief, i soaked in a hot tub several times. by this time my arm was really hurting. the next day was a bad day. my arm was hurting and red at the site. the whole muscle hurt. sort of neuropathy or numbness in my fingers and arm. my glands were swollen. at about the 30 hr mark i took pain relief. took Tylenol for about 12 hrs intervals. My arm is feeling better but it hurts off and on. As of today my finger tips are a little discolored . I also had symptoms of fever breaking but i never had fever.
66 2021-01-31 heart rate increased Nause for 3 days, rapid heart first day, fever day one, dizzy confused 3 days, dizzyness keeps retur... Read more
Nause for 3 days, rapid heart first day, fever day one, dizzy confused 3 days, dizzyness keeps returning, swollen lymph nodes in neck and sore throat for over 2 weeks, headache several days.
66 2021-02-01 blood pressure increased States feeling clammy, BP elevated during first 15 minutes of observation post vaccination, all othe... Read more
States feeling clammy, BP elevated during first 15 minutes of observation post vaccination, all other VS normal. Kept in observation until blood pressure down and no longer symptomatic, no further incident reported.
66 2021-02-01 palpitations intermittent racing heart beat
66 2021-02-01 fast heart rate CLIENT COMPLAINT OF TACHYCARDIA, DIZZINES,NAUSEA,DIAPHORETIC, ASESSED BY MD ALL S/S ARE NEW, BP INCR... Read more
CLIENT COMPLAINT OF TACHYCARDIA, DIZZINES,NAUSEA,DIAPHORETIC, ASESSED BY MD ALL S/S ARE NEW, BP INCREASED ELEVATED HR WITH PALPATATIONS, SENT TO ER VIA EMT.
66 2021-02-02 palpitations Heart started racing about 7:00 pm the night of the vaccine until today (I haven't noticed it today ... Read more
Heart started racing about 7:00 pm the night of the vaccine until today (I haven't noticed it today for the first time since the vaccine). The next morning after - so nauseous; and aching all over; so tired I could hardly move as I had joint pain, too. Couldn't throw up but nausea was there constantly - even when I went back to work on Monday I as still nauseated and still in pain. When I came home from work on Monday the body aches were gone and my leg felt numb. So it lasted a good four days for me. No treatment except drank lots of liquids and stayed still as I could so nausea wouldn't worsen. I still ache but that might be because of my ruptured disc.
66 2021-02-03 blood pressure increased sever itching flushed face raised blood pressure
66 2021-02-03 chest pain, oxygen saturation decreased Lip swelling bottom lip & numbess, Rash on stomach Dizzy, Weak, Intermitrent Chest pains, lowered ... Read more
Lip swelling bottom lip & numbess, Rash on stomach Dizzy, Weak, Intermitrent Chest pains, lowered Oxy Sat to 93 & 92. In addition to the more normal symptoms of vomiting, Diarhhea, headache, fatigue, cold & alternating sweats GI pain,
66 2021-02-03 heart rate abnormal Slight vertigo, rapid heart rate despite taking metapropol (90 - 94), arm pain. All are still ongoin... Read more
Slight vertigo, rapid heart rate despite taking metapropol (90 - 94), arm pain. All are still ongoing
66 2021-02-03 oxygen saturation decreased Patient called clinic this afternoon and reported to this nurse that she was having shortness of bre... Read more
Patient called clinic this afternoon and reported to this nurse that she was having shortness of breath, excessive coughing and O2 Sat was in the "80's." This nurse notified patient to go to nearest ER as soon as possible. Patient reported to hospital and is currently being treated. She reported sore throat, SOB, cough, runny nose that began Tuesday per hospital RN.
66 2021-02-03 fainting 7:00 PM onset of chills and fairly severe body aches - concentrated in lower back and hips. Went to ... Read more
7:00 PM onset of chills and fairly severe body aches - concentrated in lower back and hips. Went to bed early - slept to 8:00 PM. Woke up so got up to take evening meds and brush teeth. Had vertigo and moderate nausea. While brushing teeth, I fainted. Came around quickly - was on bathroom floor. Took only one of my medications - the one to prevent migraines and went back to bed. Continued with body aches and chills on and off through the night. In the morning I had worsened vertigo and nausea, but this is typical of my vestibular migraines and I think that was what was going on. I called in sick to work, took one of my pills for treating migraines and basically slept all day. I do not get migraines often - usually
66 2021-02-03 fast heart rate, chest pain Tachycardia and chest pain 25 minutes following vaccine administration. Symptoms spontaneously reso... Read more
Tachycardia and chest pain 25 minutes following vaccine administration. Symptoms spontaneously resolved after 2-3 hours.
66 2021-02-03 fast heart rate At 12:30pm 2/3/2021 Resident experienced Respiratory distress, tachypnea, tachycardia HR 155, RR 38,... Read more
At 12:30pm 2/3/2021 Resident experienced Respiratory distress, tachypnea, tachycardia HR 155, RR 38, O2 sats 48%. BP 164/149; frothy sputum from nose and mouth, lungs with coarse crackles, Temp 99. Resident required EMS transport to hospital, and was admitted.
66 2021-02-03 fast heart rate Resident received 2nd Covid 19 vaccine from Moderna on 1/26 in Rt deltoid. Immediately felt a littl... Read more
Resident received 2nd Covid 19 vaccine from Moderna on 1/26 in Rt deltoid. Immediately felt a little lightheaded during the 15 min window afterward but was able to ambulate independently with walker just afterward. After taking a nap, she woke with a headache, chills, a little shaky and feeling very tired. She was able to eat and take Tylenol at the time. For the rest of the day, she felt under the weather. The next morning she was very weak, unable to ambulate and tachycardic prompting nursing staff to send her to the hospital for assessment.
66 2021-02-04 chest discomfort On day 5 I began to have pain in my lungs, later my head started hurting and my lungs got tighter. ... Read more
On day 5 I began to have pain in my lungs, later my head started hurting and my lungs got tighter. I took a nap and woke feeling the same. I was very tired and slept for 12 hours that night. Next morning, day 6, a rash began on my chest and spread throughout the day, until it covered my entire torso and both arms. I took benadryl that night and by day 7, the rash began to subside leaving me very itchy for another day.
66 2021-02-04 heart rate irregular Sore arm, erratic heart rate (jumps between 65 and 100, muscle aches
66 2021-02-05 heart rate increased A bit over an hour after the vaccine my heart rate went to 202 beats. I was not light headed, didn?t... Read more
A bit over an hour after the vaccine my heart rate went to 202 beats. I was not light headed, didn?t feel bad but my heart started beating fast and went to 202bpm . I checked it on my finger pulse oximeter. It lasted about a minute I coughed and bear down and heart rate went back down. The next day I didn?t feel well, red rash about an inch or two below injection site, headache, tired, arm sore and temperature of 99.8.
66 2021-02-05 heart rate increased Diarrhea,vomit,headache,high heart rate , Lasted till ten pm the following day
66 2021-02-05 loss of consciousness Chills, fever, dizziness, fatigue, nausea, unsteadiness -- Chills began at 10 pm, sweating and dizzi... Read more
Chills, fever, dizziness, fatigue, nausea, unsteadiness -- Chills began at 10 pm, sweating and dizziness and nausea discovered at 1:30 am when rose to go to bathroom, brief loss of consciousness while seated on toilet, need for assistance to return to bed. Sweating ended within 20 minutes. Dizziness, nausea, fatigue, and unsteadiness continued, though gradually decreased, until 12 noon on 2/6/2021.
66 2021-02-05 palpitations heart palpitations and felt flush and over stimulated like I have had novocaine with epi at the dent... Read more
heart palpitations and felt flush and over stimulated like I have had novocaine with epi at the dentist. Breathing was fast but that might have been panic. I don't know if it was an allergy or sensitivity and am concerned about getting my second dose on February 24. 2) Also, my injection site was red and sore for the first day but got progressively worse day 2-4 with a red raised hot area and pain that made it stiff to raise my arm. By day 5 it resolved.
66 2021-02-07 ischemic chest pain, chest pain After a few minutes, noticed or felt a rapid heart beat. Waiting 15 minutes and left the facility ... Read more
After a few minutes, noticed or felt a rapid heart beat. Waiting 15 minutes and left the facility but still felt the rapid heartbeat for the a few hours. Had some fatigue by Wednesday. (Injection given on Sunday). Chest/heart still felt achy after a week.
66 2021-02-08 low blood oxigenation Patient is a 66 y.o. female presents with increasing shortness of breath and fatigue the last few da... Read more
Patient is a 66 y.o. female presents with increasing shortness of breath and fatigue the last few days. The patient presented to the ER just a few days after being discharged from Hospital. The patient was treated as an inpatient at Hospital little under a week ago for a COPD exacerbation. She showed dramatic improvement during this time, but over the last few days has started showing increasing signs of shortness of breath and severe fatigue. She has no known coronavirus (COVID-19) contact, but states that anything is possible. Her rapid coronavirus (COVID-19) test in the ER was negative. However, her chest CT seem to suggest a severe viral pneumonia. Because of this, the patient is going to be admitted to the hospital as she has failed outpatient therapy and is significantly hypoxic.
66 2021-02-08 palpitations, heart rate increased, chest pain High heart beat to 132. Hard to breathe. Chest pain. Ambulance to ER. 7 hours.Ongoing 2 weeks racing... Read more
High heart beat to 132. Hard to breathe. Chest pain. Ambulance to ER. 7 hours.Ongoing 2 weeks racing heart and chest pain wearing heart monitor.
66 2021-02-08 fast heart rate, chest discomfort Had delayed itching about 30 hours after first dose but brief and minor. Had slight minor itching w... Read more
Had delayed itching about 30 hours after first dose but brief and minor. Had slight minor itching within 15 minutes of second dose but brief and minor, taking benadryl before injection and twice after. Then 3 days later (injection on Fri 5:00 pm) reaction Monday 3:00 pm) noticed hives on both hands and some small spots on arm and itching. Over next 2 hours noticed injection site had large irregular rash-y area. Was in another county getting first aid and cpr training ironically, even going over how to use an epi-pen. Could not take benadryl as had to drive 45 min home. Started driving home and began feeling very bad with chest tightness, more itching, decided better to go to ER half-way to home as I live out in the county. At triage bp was 180/111 and had tachycardia, I think they said 145 bpm. They did EKG labs etc. Dr. diagnosed allergic reaction and tachycardia. Administered oral and IV meds and IV fluids and was discharged and home by 8:15 pm. feel fine the next day, but taking steroid and antihistamine prescription level medications to control. Meds given at hospital listed: zyrtec tablet 10 mg Pepcid 20 mg Benadryl 50 mg Solu-Medrol 125 mg NS -0.9 1000ml Lopressor 5 mg Home medications Hydroxyzine HCL 25 mg 1 tab every 6 hrs prn Prednisone 20 mg 1 tablet 2x daily 5 days
66 2021-02-09 blood pressure increased, oxygen saturation decreased On the 5th, I couldn?t tell any difference, on the 6th I felt sluggish, 7th I had a lot of muscular ... Read more
On the 5th, I couldn?t tell any difference, on the 6th I felt sluggish, 7th I had a lot of muscular pain, bone pain, blood pressure went up to 229/189 but this has happened before and I take Clonidine and it brought it down within an hour, the rest of the evening it was 94/46. My hands and feet were swelling and feet were in excorticating pain so I put them up and it went away. On the 8th it?s been the same thing, excorticating pain in hands and I must use a heat pad, my oxygen level dropped down and I was weak. Today I?m still the same and extremely fatigued. My doctor wanted to me call because I?ve had to used oxygen and have some confusion. The doctor?s office can tell that I?m not the same as before my shot.
66 2021-02-09 heart rate increased 5pm- tired, small headache, left side of neck felt like lymph nodes were swolling, laeft side of thr... Read more
5pm- tired, small headache, left side of neck felt like lymph nodes were swolling, laeft side of throat felt like lump in throat a little difficult to swallow, light headed. 5:15pm- ate dinner to check throat and was ok swallowing 6pm- lay down. Read and then slept after taking 1 Tylenol. 6:47- heart rate increase 109-115. on phone app registers as average 109 bpm. Heart rate decreased 5-10 min. later. 10:30pm- Left side of face felt like it was swelling but looked in mirror and it did not liook swollen. Difficulty sleeping. 4am heart rate checked again and was 67 bpm. Took 1 Tylenol. Friday- I felt tired, still light headed at times, left side of throat still feels a little hard to swallow but very much improved. I was active this day. Sat. some pain on left shoulder but this was not long and tired still. Sun. I feel much better and pretty much normal.
66 2021-02-10 palpitations shaking uncontrollably bad headache, took Advil every 2 hrs. weak. couldn't walk very far. I felt li... Read more
shaking uncontrollably bad headache, took Advil every 2 hrs. weak. couldn't walk very far. I felt like my heart was skipping a beat. was dizzy but already having that before the shot. Called the pharmacy and was told it was normal and to give it two weeks
66 2021-02-10 loss of consciousness, blood pressure decreased patient experienced rapid drop in BP resulting in loss of consciousness at 10min post injection. ... Read more
patient experienced rapid drop in BP resulting in loss of consciousness at 10min post injection. recovered quickly, bp was monitored and after consultation with EMS patient was allowed to leave imz siteunder her own power
66 2021-02-11 nosebleed After the pt. received her second dose of the vaccine, she was then observed for 15 minutes. Some ti... Read more
After the pt. received her second dose of the vaccine, she was then observed for 15 minutes. Some time after the vaccine (within the first two hours) pt. has a nose bleed that took about 10 minutes to get stopped (per facility staff). Pt. had no other symptoms noted.
66 2021-02-12 chest discomfort Patient complain of chest pressure 35 minutes after Moderna Vaccination 2 dose. No reaction to firs... Read more
Patient complain of chest pressure 35 minutes after Moderna Vaccination 2 dose. No reaction to first dose
66 2021-02-13 heart rate increased, palpitations At 3:30 PM on February 12, 2021, after receiving the Moderna second dose at 10:45 AM, I developed a ... Read more
At 3:30 PM on February 12, 2021, after receiving the Moderna second dose at 10:45 AM, I developed a very bad headache and overwhelming fatigue. The headache worsened, and by 4:30 was throbbing. Around that same time, I developed muscle aches in both arms, shoulders, back and knees, not unlike the onset of flu. My temperature, normally 96.7, , was rising through the evening to 97.3, 97., 97.6, and 97.9 during the evening. I was nauseous and had lost my appetite. My temperature was rising and by 7:30 was 98. I went to bed at 7:30 and woke up at 11:00 PM. My heart was pounding, the backs of both of my arms were hot to the touch. I checked my smartwatch and my heart rate was elevated to 110-120 bmp sustained. My resting heart rate is normally 60-70. I was short of breath and had shaking chills. I woke my husband and asked him to help me - I was scared. My heart rate remained very elevated through the rest of the night and well into the following day but the shortness of breath subsided. It did not come down below 90 until the later afternoon of February 13, 2021. The headache did not resolve until Sunday morning, February 14. I am still quite tired and a little achy, but all other symptoms have resolved. I considered going to the ER but decided it was an expected reaction to the vaccine.
66 2021-02-13 heart rate increased Muscle aches, chills, dizziness, sneezing, runny nose, elevated heart rate of 107, crazy thoughts, ... Read more
Muscle aches, chills, dizziness, sneezing, runny nose, elevated heart rate of 107, crazy thoughts, very intense and painful.
66 2021-02-13 loss of consciousness After beginning to not feel well--upset stomach, nauseous, lethargic , about 6 hours after shot, I h... Read more
After beginning to not feel well--upset stomach, nauseous, lethargic , about 6 hours after shot, I had trouble sleeping and felt bad during the night. I woke up about 6am and when I was brushing my teeth I felt nauseous and very weak, and then I passed out. I hit floor hard and have a good size bump on the back of my head. For the rest of the morning ( day after my 1:30 second shot), I continued to feel weak and a little nauseous. I never had a fever. I'm sending this report the morning of the second day after my second dose, and I'm feeling much better--more energy and no nausea. ---But i was pretty sick annd passing out indicates a severe reaction. I'm small--only 4 ft 11 in and 95 pounds. For my retired friends and neighbors who have been vaccinated, the smaller ladies are having much worse side effects.
66 2021-02-13 oxygen saturation decreased Severely out of breath during the night following the vaccine, oxygen level declined.
66 2021-02-14 chest pain Vaccine (2nd dose) was give around 11:00 am on 2/11/2021. Around 9:30 that night I started to feel... Read more
Vaccine (2nd dose) was give around 11:00 am on 2/11/2021. Around 9:30 that night I started to feel achy all over. Around 2:30 am I woke up with the severe chills and could not stop shaking. Fever of 100.7. I had severe headache, dizziness, n/v, severe joint and muscle pain. I had severe ear aches, my jaw and teeth even hurt. I started having left chest pain. My husband took me to ER (Billings, Montana). Chest x-Rays, EKG, and blood work were done. Everything checked out normal. I was released to go home. The symptoms were much worse than from the first covid shot and I thought the reaction from the first shot were horrible. I slept most of the day. Around 10 am on 2/13/2021 I felt better. I will never have that vaccine again!!
66 2021-02-14 fainting, blood glucose increased Moderna COVID-19 Vaccine EUA Vaccine administered at 8:30 am on 2/11/2021. Left arm started becoming... Read more
Moderna COVID-19 Vaccine EUA Vaccine administered at 8:30 am on 2/11/2021. Left arm started becoming sore about 8 PM that night. Patient took 325 mg aspirin po to relieve inflammation. Chills began at 1:30 and persisted for 3-4 hours. Patient collapsed about 6:30 PM on 2/12/2021 and EMS responded to home within minutes. Vitals were WNL. EKG showed no significant problems. Blood glucose was 144 mg/dl.
66 2021-02-15 loss of consciousness 02/12/2021, 9.15 pm Chills so intense that I was shaking uncontrollably. Then intense headache later... Read more
02/12/2021, 9.15 pm Chills so intense that I was shaking uncontrollably. Then intense headache later on that night, 3.30 am 02/13.2021, Got out of bed to take some tylenol, so weak I passed out, twice in the bathroom. I have no memory of passing out. My husband called 911 and I was taken by ambulance to the local hospital. Vital signs remained good through out. Large bump on my for-head and brushing on my chin as a result of passing out.
66 2021-02-15 pallor Patient felt light headed, felt like she was going to faint She lower her head between her knees She... Read more
Patient felt light headed, felt like she was going to faint She lower her head between her knees She got pale sat back up and complained she felt warm, sleepy and her hands tingled she become some what unresponsive Called 911 and was transported to Hospital
66 2021-02-16 blood pressure increased This person received the Moderna COVID-19 vaccine at 2:00pm; c/o dizziness, "sticky throat", itchy h... Read more
This person received the Moderna COVID-19 vaccine at 2:00pm; c/o dizziness, "sticky throat", itchy hands/palms, elevated BP; @ 2:31pm with BP 195/80; @2:49pm, BP 227/104. Took own BP medication Labetatol HCL 100 mg 1/4 tab (25mg) per primary care doctor's prescription when systolic BP over 180. At 2:56pm, transferred to Emergency Room for further follow up.
66 2021-02-17 cardiac arrest, fainting Patient collapsed and could not be revived. There was no prior warning. She was otherwise in good co... Read more
Patient collapsed and could not be revived. There was no prior warning. She was otherwise in good condition for her age. The death was listed as probable cardiac arrest but no autopsy was performed. Since it occurred so close to the vaccine shot I thought someone may want to know.
66 2021-02-17 excessive bleeding, nosebleed 2 hours after receiving the vaccine I had a nosebleed on the left side of my nose.
66 2021-02-17 loss of consciousness per patient report: "103.5 fever with heart rate of 100-120s. Farmer's Lung activated with profou... Read more
per patient report: "103.5 fever with heart rate of 100-120s. Farmer's Lung activated with profound coughing. O2 sats went transiently low to 85 but mostly 91-92%. Became very unsteady on feet, requiring support of walls, furnishings and counters. Horrible chiari headache with bad nausea Neuropathy in BLE flared, legs were buzzing and I was getting intense spasms of bilateral feet and ankles that made it hard to use them. Visual decline Passed out twice cold in the bathroom [found myself in bathroom, when "I came to"] In bed for 3 days except to use the restroom and make tea. Could not attend to any other ADLs. Injection site red from shoulder to elbow, swollen and itchy with axillary lymph swelling". Symptoms
66 2021-02-17 transient ischaemic attack TIA experienced on 2/13/2021 upon rising from sleep/found lacuner infarct on MRI in ER on 2/13/21
66 2021-02-18 loss of consciousness, fainting My mother came home after receiving the Moderna vaccine shot and did not feel well. She had confusio... Read more
My mother came home after receiving the Moderna vaccine shot and did not feel well. She had confusion, pain in her left arm near the injection site. She attempted to relax for a while and then became very nauseous, faint, and vomited. She claimed she tried to lay down in her bed and then attempted to get up to vomit and could not physically move. On Tuesday, I found her at 2:30 PM unconscious in her bed. Vomit/blood all over the floor by the bed side, her face was very warm, her breathing was very short. I could not get her to respond to me through feel or communication so I called 911. She was taken to the ER by ambulance at this time. She was taken the hospital where she was placed on IVs (I think one for antibiotic and the other was a steroid). Hospital performed blood work, CT scan, chest x-ray, and lumbar tap. They did not find any issues with my mother other than she had an "elevated white blood counter". Lumbar tap did not yield any signs of infection or foreign bacteria. She was discharged on Wednesday (02/10/2021) evening and went home to rest. She has been very fatigue since her return home and reported to me today (02/19/2021) that she had symptoms of being faint, cold sweats, and overall weakness. I checked her blood pressure and temperature and did not see a concern.
66 2021-02-18 palpitations Her injection was at about 10:55 am. About 15 minutes after the injection, patient claimed that she... Read more
Her injection was at about 10:55 am. About 15 minutes after the injection, patient claimed that she is dizzy, heart is racing. We get her seated. She wanted some water and we gave it to her. Advised her to take her mask off if she wanted. Then she she claimed that her eyes are sensitive to light and her throat is scratchy. We offered her lay down in our immunization room. At 11:45 am, she was laying flat on her back in our immunization room with both legs elevated on chair. She asked to have the light turn off. We have one of our staff to check on her every several minutes. She claimed that her feet were cold. Her husband came in the room with her and gave her his jacket to put on her feet. We offered to check her blood pressure and call EMS for her but she was not interested. At 12:04, she stated that the room is spinning. At 12:30, she was comfortable to get up assisted by one of our staff and leave. We checked on her at 5:25 pm. Per spouse, she is doing better but sleeping at the moment.
66 2021-02-19 loss of consciousness Awoke at 4 am feeling slightly nauseated, had received Moderna vaccine at approximately 4PM on Feb 1... Read more
Awoke at 4 am feeling slightly nauseated, had received Moderna vaccine at approximately 4PM on Feb 17, 2021. Arose and walked to the bathroom, sat on the toilet and was in the process of urinating as a huge wave of nausea then vertigo(room spinning) hit me. I sat through it, thinking it had passed I stood to pull up bottoms and same feeling repeated, my mind said call my husband, and get on the floor. Next thing I knew he was at my side and I was on the floor. I do not remember falling. I did incur injury to my head and lower back. I was assisted back to bed, feeling very weak, could not walk on my own, too unsteady on feet. Feeling of weakness remained for the morning hours. Chills set in with fever, as I expected, a few hours after my fall. Highest temperature 101.5 F Due to Snow storm I did not go to my physicians office that day, but did speak to him on the phone. Hydration and safety measures reviewed as well as concussion signs and symptoms.
66 2021-02-21 hypertension After receiving the Moderna COVID 19 vaccine the pt. (while walking around in the store with her hus... Read more
After receiving the Moderna COVID 19 vaccine the pt. (while walking around in the store with her husband) began to feel dizzy and weak. She came back to the pharmacy area and she was seated and had her blood pressure checked. It was high (194/84) but she reported that she does have high blood pressure and takes her med at night. She was given a bottle of water, monitored and her blood pressure was checked twice again over the next 20 minutes. It read lower each time she was checked and when it read 156/84 she said she felt fine and was ready to leave with her husband. She also said she was diabetic and had eaten a small breakfast compared to normally. She will be contacted today to make sure she is still feeling ok.
66 2021-02-21 loss of consciousness At 3 a.m. on the 21st, approximately 18 hours after vaccine, got up to go to the bathroom. Felt wea... Read more
At 3 a.m. on the 21st, approximately 18 hours after vaccine, got up to go to the bathroom. Felt weak and passed out on bathroom floor.
66 2021-02-21 fast heart rate, chest discomfort Patient complaint of shortness of breath and chest discomfort. Patient assessed by EMS. SVT detect... Read more
Patient complaint of shortness of breath and chest discomfort. Patient assessed by EMS. SVT detected and transported to Hospital.
66 2021-02-23 chest pain AFTER RECEIVING THE VACCINE TODAY, SHE COMPLAINED OF A HEADACHE AND CHEST PAIN. ON SITE EMS RESPOND... Read more
AFTER RECEIVING THE VACCINE TODAY, SHE COMPLAINED OF A HEADACHE AND CHEST PAIN. ON SITE EMS RESPONDED. VITALS ARE BELOW. SHE DID NOT TAKE ANY OF HER MEDICATIONS TODAY. SHE RECOVERED AND RELEASED TO HOME
66 2021-02-23 palpitations, heart rate irregular Client stated on initial screening that she had some post vaccine shakiness after the first dose. A... Read more
Client stated on initial screening that she had some post vaccine shakiness after the first dose. After second dose, 30 minute close observation initiated. After several minutes, client complained of palpatations and asking to have her pulse checked. Pulse palpated - assessed as irregular; VSS. Client states she doesn't normally have an irreguar heartrate. Call to EMS for evaluation. Client transported to ED via EMS stable.
66 2021-02-24 palpitations Woke up during the night gasping for air. Throat felt like it was closing in heart, racing. Duratio... Read more
Woke up during the night gasping for air. Throat felt like it was closing in heart, racing. Duration several hours.
66 2021-02-25 blood glucose increased A little more than 5 hours after vaccination, patient experienced symptomatic hypoglycemia with a Bl... Read more
A little more than 5 hours after vaccination, patient experienced symptomatic hypoglycemia with a Blood Sugar reading of 48 after eating 1/2 candy bar and drinking gatorade. She took a nap (knowing that what she had just consumed would increase her blood sugar) and woke up feeling better. She ate dinner, and her blood sugar afterwards was elevated at 397. She noted that this drop in blood sugar following the vaccine happened with the first dose as well, though she never reported it (symptomatic hypoglycemia with a blood sugar reading of 46).
66 2021-02-25 blood pressure increased Almost immediately, sore injection site, later becoming sore shoulder muscle. Around 10 pm began fee... Read more
Almost immediately, sore injection site, later becoming sore shoulder muscle. Around 10 pm began feeling like onset of flu. Woke up around 3 am with temperature of 98, chills, cramps, muscle ache, headache. Temperature rose to 99.1 around 4 am. Woke up around 7 am still feeling same. Temp at 98.8 as of 8:45 pm.
66 2021-02-25 chest discomfort pt co upper lip tingling 10 minutes after injection, waited another 10 min to see if symptoms resolv... Read more
pt co upper lip tingling 10 minutes after injection, waited another 10 min to see if symptoms resolved. pt stated lip tingling continues with right arm tingling and tightness across chest. 0.3 EpiPen injection to right thigh. 911 activated. 1:00 injection 1:10 upper lip tingling 1:13 upper lip tingling, right arm tingling, chest tightness 1:13 0.3 EpiPen to right thigh 1:20 Fire arrived 1:30 pt transported to ED
66 2021-02-25 heart rate decreased I had immediate flushing of my face and chest, slight thickening of my tongue, heart rate dropped so... Read more
I had immediate flushing of my face and chest, slight thickening of my tongue, heart rate dropped some immediately after shot at 9:18. At 10 a.m. as I was driving home, I had an acute pain in my left jaw. Stayed for about 10 minutes and then abated. I have been dizzy since then with arm soreness. My right elbow swelled up that evening, gone the next morning.
66 2021-02-25 hypertension, oxygen saturation decreased Patient said she wasn't feeling well about 10 minutes after receiving her vaccine. She felt dizzy, ... Read more
Patient said she wasn't feeling well about 10 minutes after receiving her vaccine. She felt dizzy, thought she was going to faint. We gave her ice for the back of her neck. We checked her blood pressure, it was 230/130, pulse was within normal limits. Pulse ox was low. An ambulance was called. She removed her mask and stepped back so that she could breath better and her oxygen and coloring improved. She said that her lips felt numb, so we gave her some benadryl just in case. We did not give an epi pen due to her increased blood pressure. Her blood pressure did start improving but was still high when the ambulance came. They took her to the ER for evaluation and she will be following up with her pcp also. The hospital felt that it was just a fainting episode.
66 2021-02-25 fainting fainted at 5 am following her second Moderna Covid vaccine taken the day prior. This is the second ... Read more
fainted at 5 am following her second Moderna Covid vaccine taken the day prior. This is the second time this occurred in that she fainted the next day when she took the first Covid shot30 days ago. Paramedics were called, her vitals were normal and it was recommended that we do not transport her to the hospital. When this occurred the first time, she was taken to her neurologist who diagnose a syncope for the incident.
66 2021-02-26 atrial fibrillation None stated.
66 2021-02-26 heart attack The day following the vaccine I was fine until approximately 1:30 p.m. when I suddenly got very, ver... Read more
The day following the vaccine I was fine until approximately 1:30 p.m. when I suddenly got very, very dizzy, had disequilibrium and began to feel nauseous, and had diarrhea. The dizziness increased from mild to so bad I had to hold onto the wall to walk to the bathroom. I took half a Benadryl but it continued to escalate and I took another half a Benadryl at which time it stopped escalating but did not dissipate until approximately 4:45 p.m. I called my physician who was unavailable so I just depended on the Benadryl. There were no breathing difficulties but I had a scratchy throat in the middle of the attack and my tongue went numb and tingly.
66 2021-02-27 chest discomfort Pt began to have chest heaviness almost immediately following COVOD-19 Moderna Vaccine. Minimal SOB... Read more
Pt began to have chest heaviness almost immediately following COVOD-19 Moderna Vaccine. Minimal SOB. Chest pressure rated at 2-3/10, BP 164/90. Pt transported via WC by RN to ER
66 2021-02-28 hypertension My blood pressure was dangerously high at 199/95; the bottom went as high as 111. Normally it is... Read more
My blood pressure was dangerously high at 199/95; the bottom went as high as 111. Normally it is around 110/70.
66 2021-02-28 loss of consciousness Passed out; Felt lightheaded; Upset stomach; A spontaneous report was received from a consumer conc... Read more
Passed out; Felt lightheaded; Upset stomach; A spontaneous report was received from a consumer concerning a 66 year old female patients who received Moderna's Covid 19 vaccine(mRNA1273) experienced loss of consciousness, dizziness and abdominal discomfort. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. The patient received first of two planned dose of mRNA-1273 for prophylaxis of Covid 19 infection on 14-FEB-2021 intramuscularly in left arm. Patients felt lightheaded and fell unconscious at evening of vaccine administration. EMS was called ,but patient regained consciousness by the time EMS arrived. Patient also experienced abdominal discomfort on the day she got vaccinated. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the event were considered as recovered/resolved.
66 2021-02-28 loss of consciousness very tired, migraine, low-grade fever, nausea, diarrhea, redness and swelling around the injection ... Read more
very tired, migraine, low-grade fever, nausea, diarrhea, redness and swelling around the injection site. I passed out twice due to weakness and lightheaded feeling.
66 2021-03-01 blood pressure increased, heart rate increased Immediately after receiving the vaccine, the patient had redness, shortness of breath and had signif... Read more
Immediately after receiving the vaccine, the patient had redness, shortness of breath and had significant elevations in her blood pressure and heart rate.
66 2021-03-01 chest pain frequent numerous loose stools, gas, bloating, myalgia and arthralgia, swollen lymph nodes in neck, ... Read more
frequent numerous loose stools, gas, bloating, myalgia and arthralgia, swollen lymph nodes in neck, headache, chest pain
66 2021-03-01 heart rate increased An estimation of about five minutes after receiving the Covid19 (Moderna) vaccine, my heartrate incr... Read more
An estimation of about five minutes after receiving the Covid19 (Moderna) vaccine, my heartrate increased to around 100 beats a minute (as told to me by Dr. ). My breathing felt a little different but it could have been from wearing two masks for a longer period of time than usual. After ten or fifteen minutes, I felt sort of dizzness and it didn't feel quite normal around my eyes and forehead. The staff were extremely attentive to me. I probably was there after the shot for 30-45 minutes. Dr. suggested my symptoms was due to anxiety and out of an abundance of caution, the emergency squad was called and I was taken to Hospital Emergency Department.
66 2021-03-01 palpitations, pallor She received first dose of Moderna vaccination on 1/5/2021 into left deltoid. It was painless. Appro... Read more
She received first dose of Moderna vaccination on 1/5/2021 into left deltoid. It was painless. Approximately half an hour after injection, she began to feel tingling in the left arm, hand, and fingers. It resolved on its own and she was fatigued that evening and went to bed early. The next day she had soreness of the arm, fatigue coming through the day in waves. On 1/7, low grade fever of 99.1, headache, and fatigue. She slept for 14 hours. From 1/8-11 she had no significant issues although she did feel slightly off balance. On 1/12, she noticed left axillae lymphadenopathy and had soreness at the injection site again, which worsened the next day. On 1/14, arm was red, swollen, and tender to touch. These symptoms persisted the next day and she began to have numbness and pins and needles of the left hand. She was given 7 days of dexamethadone and cephalexin by her PCP. She slept very poorly. The next day, the numbness, swelling, and redness were all improved. On 1/17, she continued to gradually improve and there was no swelling and only slight numbness. She did have fatigue, headaches, and insomnia. On 1/21, she had visit with an allergist to discuss preventative measure for second dose. A delayed reaction was theorized and a preventative course of premedications was outlined. The next day, the numbness in the hand worsened and headache returned. On 1/23, she felt headache, confsuoin, anger, imbalance, pins and needles in the hand, difficulty holding a glass with one hand. On 1/24 pain at the injection site recurred. She felt there was change in her vision and hearing, nausea, vibration throughout the body, mouth numbness, and heart racing. On 1/25 all these symptoms persisted other than improvement in confusion. On 1/26-27, she had continued pins and needles in hands and feet. Still felt vision and hearing were "off". She was fatigued and body felt "like jello". On 1/28, she was prescribed a second course of dexamethasone as well as citalopram 20mg and diazepam. With citalopram, she had nausea, hot/cold sensations, dizziness, insomnia. She also had itching of the arm, back, leg; tremor, thirst, and pallaor. She reported symptoms to PCP and citalopram was discontinued next day. On 1/30-31 she felt disoriented at times, intermittent arm soreness, noted small abnormal bruising, hot/cold, off balance, headache, and fatigue. Since that time, predominant symptoms have been daily headache. Wakes with left posterior dull aching which escalates through the day 5/10 but will become 8/10 if she does not take anything. She is taking ASA in AM daily with second dose around 3PM when headache recurs approximately 5x/week. Sensation in feet has normalized, but she continues to have numbness in left>right hand. She feels off balance with need to specifically concentrate when walking. No falls. She also has persistent abnormal tremor of left finger. When she goes to type, she will press key 3-4 times. She feels difficulty opening water bottles, but is able to do some. She is lifting pans with both hands.
66 2021-03-02 chest discomfort Pressure between shoulder blades. It went away then started again on carotid then down arm; Sore arm... Read more
Pressure between shoulder blades. It went away then started again on carotid then down arm; Sore arm; hot feeling initially; A spontaneous report was received from a consumer, who was a 66-year-old, female patient who received Moderna's COVID-19 vaccine and who experienced a serious adverse event of chest discomfort requiring hospitalization (reported as: "heart attack like symptoms, pressure between shoulder blades that went away and then started again on her carotid then down her arm" and in addition non-serious events of sore arm, and hot feeling. The patient's medical history included borderline type 2 diabetes and allergies to adhesive tape, bleach and chlorine. Concomitant product use was not provided. The patient received her first of two planned doses of mRNA-1273 (LOT 012M20A) on 05-Feb-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. Initially on 05-Feb-2021, patient experienced a sore arm that was warm to the touch. However, on 15-Feb-2021, she reported having had heart attack-like symptoms. She stated that it started as pressure between shoulder blades that initially went away and then started again on her carotid and travelled down her arm. She thought it was from loading wood. The patient then went to Emergency Room (ER) where she received a nitro pill which alleviated the pain. The EKG, cardiac enzyme tests, nuclear imaging and stress test were all negative according to the patient's report. She reported having been hospitalized for 2 days. Treatment for the event included a nitroglycerin tablet. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, sore arm, hot feeling initially, heart attack like symptoms, pressure between shoulder blades that went away and then started again on her carotid then down her arm, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship for events cannot be excluded.
66 2021-03-02 palpitations Fatigue, nasal congestion and headache immediately after vaccination on 2/26/21 and that night fast ... Read more
Fatigue, nasal congestion and headache immediately after vaccination on 2/26/21 and that night fast heart rate, burning lymph nodes on right side, burning tissue around right hip prosthesis, burning right eye and tongue, severe pain in right glute muscles and lower spine, back of neck felt still and slightly swollen, lightheaded and felt cold. Symptoms continued the following day. By 2/28/21 burning symptoms and fast heart rate ceased, still had dull headache, congestion and fatigue, plus pain in lower back and right hip. On 3/02/21 noticed hard lump, like a boil, near right hip prosthetis scar, felt cold, tired and dizzy all day. On 3/03/21 another hard lump, like a boil, on left neck.
66 2021-03-02 fast heart rate about 5-7 days after 1st dose i developed swelling and tenderness on the side and behind my right kn... Read more
about 5-7 days after 1st dose i developed swelling and tenderness on the side and behind my right knee
66 2021-03-02 blood clot Anxious; Tired; Blood clots in left leg, right leg and brain; A spontaneous report was received from... Read more
Anxious; Tired; Blood clots in left leg, right leg and brain; A spontaneous report was received from a consumer who was also a 66-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed blood clots in the left leg, right leg, and brain, anxious and tired. The patient's medical history was not provided. Concomitant medications reported included vitamin D, magnesium, lisinopril, and vitamin B12. On 14 Jan 2021, approximately 3 days prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 16 Jan 2021, the patient experienced immense pain in the middle of the night, and subsequently saw her primary physician. An ultrasound revealed blood clots in her left leg, right leg and brain. A hematologist and vascular surgeon were consulted. Patient was treated with apixaban while they are doing blood work. The patient also became tired and anxious. She noted that she never had comorbidities before and was upset that her life has completely changed. A repeat ultrasound was scheduled for 19 Feb 2021. The mRNA-1273 dose was discontinued in response to the event of blood clots in the left leg, right leg, and brain, anxious and tiered. The outcome of events, blood clots in the left leg, right leg, and brain was considered unknown at the time of this report. The outcome of the events, tired and anxious were considered not resolved at the time of this report.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
66 2021-03-03 chest discomfort Pt reported back to the clinic 35 minutes after receiving the vaccine reporting feeling dizzy with t... Read more
Pt reported back to the clinic 35 minutes after receiving the vaccine reporting feeling dizzy with tingling of lips and tongue tingling along with chest tightness/shortness of breath
66 2021-03-03 chest pain Chest pain; Joint aches; Body aches; Fever; Chills; Fatigue; Nausea; A spontaneous report was receiv... Read more
Chest pain; Joint aches; Body aches; Fever; Chills; Fatigue; Nausea; A spontaneous report was received from a 66 year old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced chest pain, body and joint aches, fever, chills, fatigue, and nausea. The patient's medical history was not provided. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 on 10-Jan-2021. On 11-Feb-2021, approximately 2 days prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for the prophylaxis of COVID-19 infection. On 11-Feb-2021, the patient developed body and joint aches, chest pains, fever, chills, fatigue, nausea, and just hurt all over and felt terrible. On 12-Feb-2021, the patient's symptoms persisted, and she was in the emergency room (ER) to be treated. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable. The outcome of the events, chest pain, body and joint aches, fever, chills, fatigue, and nausea, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
66 2021-03-03 heart rate increased Headache, pain and rapid pulse
66 2021-03-03 loss of consciousness Patient had completed her 15 minute observation when she stood up to place her coat on. She stepped ... Read more
Patient had completed her 15 minute observation when she stood up to place her coat on. She stepped to the side of her chair began to sway, her feet shuffled, her knees buckled and she feel to her bottom and then back on her head. When I and the EMT arrived to her she seemed to be out. She came to quickly and was taking to us. She then was alert oriented to person and place. She knew the date but could not state the year. She also could state the month and date of her birth but not her birth year. When asked what happened She stated she go lightheaded and fell. She couldn't remember the incident. She remembered standing felling lightheaded and then she remembers being on the ground with myself and the EMT talking to her. Took HR and BP. We got her to a sitting position on the floor when she was ready. Took HR and BP. Then we stood and sat her in a chair. Took HR and BP and obtained a Glucose. Called her sister to come to the vaccine center. Talk to patient about going to the ED. The ED doctor who was communicating with EMT requested patient goes to the ED. Patient initially was refusing. Patient went to the restroom with assist of her walker and nurse. She was still a little unsteady. Patient did agree to go to ED. Sister arrived and we filled her in on the events. Ambulance arrived and we sent patient to the ED
66 2021-03-04 blood glucose increased High fever - up to 102 when I normally register 97.1 on our home thermometer Achy; chills; headache ... Read more
High fever - up to 102 when I normally register 97.1 on our home thermometer Achy; chills; headache Slept a lot; no appetitive Blood sugars went crazy on the high side. I am normally very well regulated in the morning ranging from 80 to 90 - has not been below 150 in the am the last couple of days. Diarreha.
66 2021-03-04 blood pressure increased, palpitations Within a few minutes I started feeling light-headed. It came in waves and then I became so dizzy I h... Read more
Within a few minutes I started feeling light-headed. It came in waves and then I became so dizzy I had to lay down. My heart starting racing, my legs were shaking, I got chills, and my blood pressure shot up.
66 2021-03-04 fainting Passed out. Low BP 83/42.Felt better after fluids. Also chills and achy flu symptoms lasting 12 hrs.... Read more
Passed out. Low BP 83/42.Felt better after fluids. Also chills and achy flu symptoms lasting 12 hrs. This was 2nd dose; no reaction to first other than sore arm.
66 2021-03-04 fast heart rate, heart rate abnormal pt was given first dose of covid vaccine moderna, she developed tachycardia, pvc's, and sweaty . pt ... Read more
pt was given first dose of covid vaccine moderna, she developed tachycardia, pvc's, and sweaty . pt with history of non obstructive cad, pt was transported to ER and discharged in stable condition
66 2021-03-05 blood glucose increased blood sugars went up to 600 on the first night and has been in high 400's at night but sugars are fi... Read more
blood sugars went up to 600 on the first night and has been in high 400's at night but sugars are fine during the day
66 2021-03-05 hypotension Low blood pressure starting approximately 15-17 hrs hours after vaccination, continuation of symptom... Read more
Low blood pressure starting approximately 15-17 hrs hours after vaccination, continuation of symptoms at least 3 days after vaccination. It was challenging to stand on my own, extreme light-headedness, blood pressure wasn't taken until March 6th. The symptoms were the worst on March 4th, they improved over the past day or so, however when taking blood pressure reading on March 6th, 2021, blood pressure was 110/60 at 8 am, so it is highly indicative that blood pressure was even lower in the previous days. Other accompanying symptoms on 3/4 were headache, low fever, fatigue, sore arm, achiness (expected side effects). Other side effects on 3/5 were nausea and metallic taste (expected side effects). There were no swelling of throat or breathing problems.
66 2021-03-07 chest pain Began having upper chest pain when taking deep breaths and when lying down. Chills Night sweats Fati... Read more
Began having upper chest pain when taking deep breaths and when lying down. Chills Night sweats Fatigue Body Aches and pains
66 2021-03-07 palpitations, chest discomfort Vaccine #1 - slight fatigue and muscle aches; 10 days after vaccine, developed redness and itchiness... Read more
Vaccine #1 - slight fatigue and muscle aches; 10 days after vaccine, developed redness and itchiness at site of vaccine and back of throat itchy Vaccine #2 - extreme fatigue and muscle aches; arm soreness; headache; lightheaded. Day #2 developed lip swelling, swelling under eye, heart racing; insomnia for 36 hours (not enough to go to ER). At the end of the 48 hour period after vaccine, developed tightness in the chest.
66 2021-03-08 hypertension An hour after the injection I began to feel light headed, off-balance and somewhat nauseous. In the ... Read more
An hour after the injection I began to feel light headed, off-balance and somewhat nauseous. In the next half hour, I went to lie down on the floor of my office because the room was spinning and I was extremely nauseous. A doctor in the building checked my vitals and ordered an ambulance to take me to the hospital. The EMTs checked my vital and my blood pressure was quite high. They started fluids and added Zophran for nausea while in the office. In the emergency room , again my vitals were checked and the Zophran was beginning to calm down the nausea. I slept for an hour (or two) and the spinning had stopped. I was discharged around 5:15pm.
66 2021-03-08 palpitations pt stated that the morning after the covid vax she felt nauseated, fatigued, had chills, racing hear... Read more
pt stated that the morning after the covid vax she felt nauseated, fatigued, had chills, racing heart beat, strange taste in her mouth. One week after getting the vax she still has all of these symptoms and has an appt w/ her PCP on 3/11/2021. She states she feels like she did when she had carbon monoxide poisoning 3 years ago.
66 2021-03-08 platelet count decreased, pallor, low blood platelet count, excessive bleeding, haemoglobin decreased autoimmune hemolytic anemia & immune thrombocytopenia which worsened rapidly post-vaccine symptoms -... Read more
autoimmune hemolytic anemia & immune thrombocytopenia which worsened rapidly post-vaccine symptoms - bleeding, short of breath, incredibly tired, pale, weak - symptom onset 8 hours post-vaccine rapid progression for first 24 hours post-vaccine) blood transfusion, platelet transfusion, treatment with steroids' (still undergoing treatment and seeing no improvement at this point)
66 2021-03-09 chest discomfort Swelling on right arm near the shot but below it, hot to touch, painful, very itchy. Tightness in c... Read more
Swelling on right arm near the shot but below it, hot to touch, painful, very itchy. Tightness in chest for one day after shot; a little difficulty breathing
66 2021-03-10 chest discomfort, chest pain Fever 101.5 for 3 days chest pain SOB heaviness in chest upon exertion since 02/19/2021 to present
66 2021-03-10 chest pain Next day - Significant pain in chest, ribs, and back. Pain from moving, laughing, & even talking. H... Read more
Next day - Significant pain in chest, ribs, and back. Pain from moving, laughing, & even talking. Headache and malaise which subsided the next day. Chest/rib pain subsided completely on 3rd day after vaccine. Almost no pain at injection site. On 8th day - Significant redness near injection site. Itching and hardnes of the tissue where redness was. Still present.
66 2021-03-10 nosebleed A few small blisters on roof of my mouth. Bloody nose - mild
66 2021-03-10 palpitations Monday day 1 Very slight headache Felt a little neuro within in 20 minutes Slight headache comes an... Read more
Monday day 1 Very slight headache Felt a little neuro within in 20 minutes Slight headache comes and goes Pain set in bones l. 2nd toe, back, hips, neck, elbow, ankle Some leg muscle pain Lymph nodes little pain and swollen Ears blocked Tired-slept 3 hrs in the afternoon Bedtime falling asleep-heart pounded 3 times Very cold Got very hot during night Day 2 Heart hurt upon waking, but then burped a lot -heartburn? Tired Air hunger Pain to include where ankle injury was Heart palpitations at rest in a.m. Felt 75% better during day Did chores Got very tired after having a snack-went for a nap at 2:30-4 Wed. Day 3 Heartburn Air hunger Lymph noes still swollen Ok during day-went out Pain set in by evening Neck, back, shoulders Day 4 Thurs. - still have back pain-took ibuprofen Tired
66 2021-03-10 palpitations After 15 minutes my heart began pounding and then my head started hurting and SS I arrived home, I... Read more
After 15 minutes my heart began pounding and then my head started hurting and SS I arrived home, I became nauseated and began vomiting which lasted 6 days. I?m still very weak and unsure if I should take the second dose. I thought I was going to die.
66 2021-03-10 fast heart rate Received report that client was admitted to the hospital on Feb 27th with persistent tachycardia. C... Read more
Received report that client was admitted to the hospital on Feb 27th with persistent tachycardia. Called client on March 11 to inquire. Client shared that she has felt weak since having COVID-19 in September 2020 and was hospitalized for 3 months. She shared she has felt weak since having COVID-19. She shared that on the morning after receiving the vaccine she was getting out of her bed, which is on the floor, and she hit her head. She shared that her daughter was concerned and took her to the emergency department (ED). While there in the ED her blood work ?wasn?t right? and they thought she might have a small blood clot in her lung and she was admitted. While in the hospital she received eliquis which she had a reaction to. She shared she was in the hospital for 1 day. Recommended she see her PCP for these health concerns as well as before receiving the 2nd dose of a COVID-19/Moderna vaccine.
66 2021-03-10 troponin increased dizziness described as spinning while in bed on Tuesday morning associated with episodes of diaphore... Read more
dizziness described as spinning while in bed on Tuesday morning associated with episodes of diaphoresis, and chills. This morning she awakened and noted left facial swelling and left lip swelling
66 2021-03-11 nosebleed Fever, shaking chills, body aches, headache, brain fog, fatigue, bloody nose that was difficult to s... Read more
Fever, shaking chills, body aches, headache, brain fog, fatigue, bloody nose that was difficult to stop
66 2021-03-11 loss of consciousness Patient reports waking up around 3 AM on 3/5/2021 with fever, aches, headache, and chills. Reports t... Read more
Patient reports waking up around 3 AM on 3/5/2021 with fever, aches, headache, and chills. Reports taking Tylenol and feeling better around 10 or 11 AM. Then around 1:30 PM (24 hours later) patient reports being in kitchen preparing a sandwich and started to not feel well. Patient sat in chair to take blood pressure, while taking blood pressure patient passed out. Patient reports waking to grand-daughter rubbing back and she stated, "I passed out didn't I". Patient letting health care provider know. Patient reports having A-FIB 9/2/2021 was feeling sick, headache, and chest discomfort. Reports going to ER Monday September 7, 2020 after being tested for COVID-19. Reports Negative results for COVID-19. Reports passing out and having a 5 day stay in the hospital.
66 2021-03-11 oxygen saturation decreased, blood pressure decreased She got the vaccine, and within 2 minutes she felt nauseous. Then she stayed there for 30 minutes, ... Read more
She got the vaccine, and within 2 minutes she felt nauseous. Then she stayed there for 30 minutes, and after she left about 2 hours later had a headache. Then about 3 hours after that she had chills and her normal temperature which is 97.3, it went up to 99. Then after that probably 4-5 hours later her BP dropped down to 70/50 which her normal high range is 90 Her heart rate was going from 38 to 103. Her oxygen level went down to 88, which normal is 91, this was around midnight. She was sleeping off and on, lethargic all day long. Got up in the middle of the night to go to the bathroom and her whole body inside was shaking and afraid that she was going to fall down, and fell back to sleep. The next day when she woke up still had the headache, still felt nauseous, but the other symptoms subsided. About 30 hours later she started feeling much better, with the headache and all symptoms subsiding around 5:00 PM the following evening. All her VS returned to their normal range. She called her doctor and after they called her back on Monday and advised her not to take the 2nd vaccine, her PCP. Her Cardiologist who suggested that she wait 90 days for the 2nd one.
66 2021-03-11 pallor Approximately 25 minutes after receiving the COVID vaccination, patient reporting not feeling well. ... Read more
Approximately 25 minutes after receiving the COVID vaccination, patient reporting not feeling well. She stated she felt like it was difficult to swallow and to speak and that her tongue felt bigger, she also experienced voice changes, and pallor. BP 126-68, HR 65. 0.5mL of epinephrine were administered intramuscularly in the opposite deltoid, and the patient verbalized an improvement in symptoms. EMS arrived on scene and evaluated the patient. Patient refused EMS transport, but did take private transportation to the local hospital - where she was evaluated and discharged home.
66 2021-03-12 blood pressure decreased Received second dose of Moderna vaccine afternoon of Feb 25, 2021. (had no significant reaction to ... Read more
Received second dose of Moderna vaccine afternoon of Feb 25, 2021. (had no significant reaction to first dose 4 weeks earlier). Patient is handicapped with severe Lupus neuropathy but lives alone. Around 1 AM of Feb 27 fell when arising from chair. Called 911 but refused EMT suggestion to go to ER. At 8 AM her daytime aide found her on floor, confused. Called 911 and EMTs took her to ER where she was admitted to hospital with BP 84/40, Temp 103.1. Dx dehydration vs infection. Responded to IV fluids. After 3 days in hospital was discharged to facility for rehab. Doing well and plan is for discharge to home on Marc 19, 2021.
66 2021-03-12 heart rate increased, chest pain Severe headaches, chest pain, rapid heartache,short of breath
66 2021-03-12 hypertension I got extreme Vertigo- vomited and was dizzy for 7 hours. I was dizzy for 3 days after and now have ... Read more
I got extreme Vertigo- vomited and was dizzy for 7 hours. I was dizzy for 3 days after and now have some dizziness. I went to the doctor after 4 days- had very high blood pressure (not normal for me), had an EKG (normal), and am waiting for blood work to come back.
66 2021-03-12 palpitations, chest discomfort, blood pressure increased Noticed my eyes were completely dilated and felt dizzy. After about an hour of noticing eyes, I star... Read more
Noticed my eyes were completely dilated and felt dizzy. After about an hour of noticing eyes, I started to feel really funny in my chest with pressure, dizziness blurry vision, racing heart. I checked blood pressure and it was 220/110. I tried to lay back and it felt worse. At the same time I was nauseated and felt like I was going to have diarrhea and vomit at the same time. Started with severe vomiting and chills that felt more like tremors than chills. The vomiting stoped during the night but my blood pressure stayed elevated for three days starting around 180/110 to 180/100. Finally it slowly came down to around 150/90 for two more days. Then back to normal at 130/80.
66 2021-03-12 fainting chills beginning night of vaccination. Then around 1:00am urgent need to urinate and again around 2:... Read more
chills beginning night of vaccination. Then around 1:00am urgent need to urinate and again around 2:00am. After the 2:00 bathroom visit I found myself on the floor of the bathroom between the toilet and the shower. I tried to get up but couldn't and managed to get out of the spot I was in but unable to get up. I continued to try but was unable to. after two hours of moving, trying to get up and resting where I was I managed to get to my bedroom (a distance of under 12feet). I felt like my muscles weren't working properly. I called 911 to help me get off the floor and was taken to the closest ER. By 7am on March 12th I was able to get up and walk on my own. Although my arms and legs are bruised I feel much better today.
66 2021-03-12 troponin increased, pulmonary embolism, loss of consciousness Saddle blood clot in lung. Place in ICU for 1 day. Then regular room. Heparin drip to Apixaban. No a... Read more
Saddle blood clot in lung. Place in ICU for 1 day. Then regular room. Heparin drip to Apixaban. No activity. All medical tests indicated no cause of blood clot. Vitals great. Past out twice and threw up night it started
66 2021-03-13 blood pressure increased Fever, pain in arm, increase blood pressure, back of head pain, body aches
66 2021-03-13 hypertension, palpitations Extreme body aches and joint swelling Sever headaches, fevers for 4 days 100.3-103. Full leg and fi... Read more
Extreme body aches and joint swelling Sever headaches, fevers for 4 days 100.3-103. Full leg and finger cramping High blood pressure and racing heart beat
66 2021-03-13 hypertension Bight blood pressure, never had high blood pressure until the vaccine. This goes for both my husban... Read more
Bight blood pressure, never had high blood pressure until the vaccine. This goes for both my husband and myself. Very troubling, we are both now on blood pressure meds to control this side effect.
66 2021-03-13 loss of consciousness, nosebleed Passed out and fell face-first on a tile floor. Teeth cut inside lip requiring many stitches. Glas... Read more
Passed out and fell face-first on a tile floor. Teeth cut inside lip requiring many stitches. Glasses cut across my nose. Hit left cheek bone - bruised. Bloody nose. Bruise and cut on right shoulder where I must have hit the counter on the way down. Sore forehead. Headache.
66 2021-03-13 pallor a 66 yr old female In observation area began c/o dry throat, itchiness in eyes, diaphoresis and diz... Read more
a 66 yr old female In observation area began c/o dry throat, itchiness in eyes, diaphoresis and dizziness @17-20 minutes post Moderna COVID vaccine. Prior to this pt was interacting with RN doing V safe registration. Pt requested Water, drank 8 ounces of water without swallowing difficulty. Then pt became pale and requested PO Benadryl. Per adverse drug reaction kit, 25 mg /10 ml PO Benardyl given. Lot # 502935 exp 2/28/22 BP 146/87 large cuff on left arm -pt reported "I have high blood pressure" Pt advised to wait additional 15 minutes. Within 5 minutes pt skin pallor resolved, diaphoresis resolved along with dry throat and eye itchiness. Within 10 minutes pt drank another mini water bottle and again stated " I feel much better" Advised pt to call daughter from parking garage area to help assist pt to d/c. pts daughter is an RN also. Pt was able to ambulate independently though c/o feeling slightly tired stated "Benadryl usually makes me very sleepy" Pt d/c to home w/daughter @6:35 pm. Advised to call KP advice PRN any s/s worsening and to notify MD for precautions prior to second dose of Moderna scheduled. Pt agreed w/plan and verbalized understanding.
66 2021-03-13 fainting Fainting spell (had it in line too, before receiving vaccine) - given juice and crackers.
66 2021-03-14 ischemic chest pain 36 hours of depilitating headache, chills, body ache, and fever. I was bedridden. Throat swollen, h... Read more
36 hours of depilitating headache, chills, body ache, and fever. I was bedridden. Throat swollen, hard to swallow. Mild angina when reaching down to floor. I have a history of high tolerance for pain. This stopped my world for a day and a half. Better now.
66 2021-03-14 blood pressure increased, chest discomfort Days 1-2 I had fever of 101, chills, aches, diarrhea, headache Days 3-11+ (still not resolved) I ha... Read more
Days 1-2 I had fever of 101, chills, aches, diarrhea, headache Days 3-11+ (still not resolved) I have experienced nerve pain though out my body, legs, knees, arms, elbows, shoulders, back , face, chest Feels like I am on fire. Went to medical center, physician's office 2x's, ER ( when I experienced chest tightness, elevated blood pressure)
66 2021-03-14 chest pain Chest pain radiatinig down left arm since day after moderna vaccine. Took nitroglycerin twice. Some ... Read more
Chest pain radiatinig down left arm since day after moderna vaccine. Took nitroglycerin twice. Some nausea. Presented to ER for chest pain for 2 days, paininto left arm, No acute changes in EKG, non-cardiac chest pain. Medication changes made per cardiologist.
66 2021-03-14 chest pain Headaches, dizziness, sore throat, head pain more on right side, both eyes pressure (soreness), righ... Read more
Headaches, dizziness, sore throat, head pain more on right side, both eyes pressure (soreness), right eye lid dropped for a few minutes I couldn't lift it, only the right eye heavily twitching, nose pressure pain, inner ear pain (more on right side), teeth and gum soreness, neck pain, chest pain (pressure). Two severe days ( February 28th and March 1st) and then it gradually got better by end of two weeks. I'm 96% back to normal today. Still having occasional slight pains in head, ear, nose and throat. Advil and Tylenol help.
66 2021-03-14 heart rate increased Started with chills, took hot shower, went to bed with electric blanket throw and 2 quilts, fell asl... Read more
Started with chills, took hot shower, went to bed with electric blanket throw and 2 quilts, fell asleep and awoke around midnight to urinate, severe chills, and heart seemed to be racing. I checked my Fitbit on my wrist, and it said pulse was at 93 normally runs around 52 resting. My breathing was heavy. My head felt like someone tried to strike me with an axe down the center. I woke again at around 2:00 a.m. My breathing was still heavy. I decided to check my temperature and it was 101.4. My arm was hurting where I had the injection but nowhere near like my head hurt. I woke again around 4:00 to urinate, checked my temperature and it was up to 101.7. But then it started coming down and was around 101.4.
66 2021-03-14 heart rate increased I started exp rapid heart beat lasted couple hours.I took my evening medications for mitral valve fo... Read more
I started exp rapid heart beat lasted couple hours.I took my evening medications for mitral valve for heart beats. The following day still exp nausea couldn't eat for few days. Also exp little temp, vertigo and headache. On third day vertigo really bad and nausea. The next day on Monday exp sore throat and right side lymph nodes swollen.The vertigo and nausea lasted a week,the neck pain on my right side lasted 3-4 weeks.
66 2021-03-14 hypotension On 2/21/21 she noticed a headache, dizziness, fatigue and low blood pressure. She noticed the s/s b... Read more
On 2/21/21 she noticed a headache, dizziness, fatigue and low blood pressure. She noticed the s/s because she had this same delayed reaction after the Shingrix vaccine in 2018.
66 2021-03-14 loss of consciousness Woke up around 2 am with stomach cramps, loose bowels, nausea, chills, sweating, dizziness, sore lef... Read more
Woke up around 2 am with stomach cramps, loose bowels, nausea, chills, sweating, dizziness, sore left arm, very shaky feeling. Went to bathroom for bowel movement, had trash can in front of me in case of vomiting. Apparently passed out and fell off toilet. Woke up on floor, on my right side, with very cold chills and sweating. Finished going to bathroom. Noticed small cut on forehead, with dried blood, probably from hitting my head on trash can I was holding. Went back to bed. Still dizzy, chills, sweating, stomach cramps, nausea, sore arm, and aching all over. These symptoms persisted for hours. Finally fell asleep, woke up around 7:30 am, still dizzy, stomach cramps. Took temperature, normal, took blood Additional information for Item 18: pressure, also normal. Called office of primary care doctor, not open on Friday, declined appointment with another doctor, left detailed message, and was told they would contact me on Monday. Went back to sleep, woke around 11:15 am, still nauseous and stomach cramps and dizzy. Went back to sleep until around 2:30 pm. Woke up feeling better, still sore left arm, sore stomach, achy and very tired.
66 2021-03-14 oxygen saturation decreased Patient reports within 2 mins after getting vaccinations she started feeling nausea (but did not vom... Read more
Patient reports within 2 mins after getting vaccinations she started feeling nausea (but did not vomit). 1 hour later she had a Headache, chills, temp went up to 99, body aches. After 4 hours he bp dropped 70/50- for almost 8 hrs Then her o2 saturation dropped - 88% RA Her HR bounced from 38 - 103 bpm In the middle of the night she got up to use to bathroom and she felt very weak was about to fall and her whole body was shaking she started feeling better the next day around 5pm (effects lasted about 30 hours). She called her Cardiologist recommended not to get the second shot for at least three months. Her PCP recommended to not get the second dose and to call to report adverse reaction she had with the first dose.
66 2021-03-14 fainting First started with nausea, slept because was very tired, this is now 10 hrs after vaccine. Went outs... Read more
First started with nausea, slept because was very tired, this is now 10 hrs after vaccine. Went outside after nap for short walk with husband, started sweating, came in house was getting sick to stomach. Started vomiting, dry heaving then passed out hit chin and fell hit head on tile floor. continued with dry heaves, got chills. We called for ambulance EMT to check vitals. Decided not to go to hospital, to wait it out. Vials were ok just blood pressure was up.
66 2021-03-15 blood pressure increased Pt received her 1st Moderna covid vaccine at Clinic on 3/11/21. She noted a history of bee stings an... Read more
Pt received her 1st Moderna covid vaccine at Clinic on 3/11/21. She noted a history of bee stings and that she has an epi pen at home so was given the shot and monitored for 30 minutes. 20 minutes post vaccine, patient noted she felt dizzy and somewhat disoriented. She noted a dry throat and like her arms and legs felt funny "like jello". Her husband alerted staff at the vaccination site and EMS assessed her. She said she was told her blood pressure was high for her but otherwise vitals were fine. She denied itching, or shortness of breath or trouble breathing. She actually asked her husband to go home and get her epi pen and he returned with it and was given a dose of epi and sent to the local emergency room for evaluation. She said she felt better by the time she got their but was monitored for a number of hours. She felt completely fine by the time she was discharged. She noted for a few days following the vaccine she felt fatigued and a slightly itchy spot at injection site but that's it.
66 2021-03-15 body temperature decreased Initial sore arm at injection site, become slightly swollen and more tender to touch about 12 hours ... Read more
Initial sore arm at injection site, become slightly swollen and more tender to touch about 12 hours after injection- low grade temp, body aches, headache Treated with alternating ibuprofen and acetaminophen symptoms continued for approximately 36 hours after injection
66 2021-03-15 heart rate increased, body temperature decreased Hello, FYI: My first Moderna vaccination I had a sore arm and fatigue for a day. For my second Mode... Read more
Hello, FYI: My first Moderna vaccination I had a sore arm and fatigue for a day. For my second Moderna vaccination it was at 0745 6 Mar 2021. Twelve hours later side effects began. The first night was brutal. Temperature rapidly rose to 102. Joint aches, fatigue but couldn't sleep due to the pain, loss of taste and smell, nausea, felt real cold, shakes, congestion, gassy, hurt to breath, headache, shallow breathing, slightly elevated heart rate. I drank a lot of water and hot Green Tea. I did call the medical center and spoke with a nurse about whether it was Covid or side effects to the second vaccination. Second day was miserable; I still had a fever that gradually went down. Finally was able to sleep end of second day. I continued to drink a lot of water and hot Green Tea. Third day, still fatigued, mild heachach. Mild sore arm for three days. Third through nine days I have a below normal temperature, hoarseness, mild headache, and fatigue. the medical center gave me annual flu vaccinations. I've never had a side effect from them. While I was in the medical center, before I was deployed overseas, the medical center gave me some dozen vaccinations. Again, no side effects from them. I have never been around anyone who turned out later to have Covid 19 or tested positive for it. I have never had the flu. I have had some four cases of a cold. Worst illness was after my exposure to norovirus. I was gravely ill, had to be admitted to the hospital here. Norovirus worse than the two cases of food poisoning I had. I figure with those awful side effects I now have an immune system better able to handle Covid 19 if I do get exposed. Per CDC, I will still wear a mask, social distance, avoid medium- and large-sized crowds, avoid poorly ventilated public and private spaces, and wash my hands frequently for the forseeable future.
66 2021-03-15 low blood platelet count, platelet count decreased, low platelet count Thrombocytopenia-ITP. Platelet undetectable <5
66 2021-03-16 heart rate decreased, palpitations Heart flattering fast; Her resting heart race is 54-56, but that morning was higher; Sore arm; This ... Read more
Heart flattering fast; Her resting heart race is 54-56, but that morning was higher; Sore arm; This spontaneous report was received from a consumer (patient) and concerns a 66 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was sore, felt the heart flattering fast. Her resting heart race was 54-56, but that morning was higher. The patient was very active, exercised every day and ate very healthy. Patient was a very healthy person and has no medical conditions, only was allergic to Sulfas. On 09 Feb 2021, the patient received her first dose of mRNA-1273 (Lot number: 016M20A) solution for injection intramuscularly in her left arm for prophylaxis of COVID-19 infection. On 10-Feb-2021, patient felt the heart flattering fast. This sensation lasted 2 minutes. The doctor stated that this could be a heart attack and because it happened after receiving the Covid-19 vaccine, this could be a possible side effect. On 10 Feb 2021, the patient resting heart race was (54-56s), but in the morning it was higher. On an unknown date the patient had laboratory test AKG. Seriousness Criteria for the events of heart flattering fast was medically significant. Action taken with suspect drug mRNA-1273 was unknown; Reporter's Comments: Being sent back to CP
66 2021-03-17 heart rate increased, blood glucose increased anaphylaxis, asthma attack, heart racing, dizziness, severe headache, pain in left side from shoulde... Read more
anaphylaxis, asthma attack, heart racing, dizziness, severe headache, pain in left side from shoulder to waist, numbness in both hands, pain in right arm from shoulder to hand with numbness and tingling sensation. Inabiltiy to walk or stand, red eyes, swollen faces, shortness of breath, weakness in legs, rise in blood sugar levels, feeling light headness, fever, sore throat, chills.
66 2021-03-17 heart rate increased, fast heart rate Throbbing arm pain, splitting headache, tachycardia, heart rate up to 115, fatigue, insomnia,, left ... Read more
Throbbing arm pain, splitting headache, tachycardia, heart rate up to 115, fatigue, insomnia,, left eyelid swollen
66 2021-03-17 hypotension Patient reports that she starting having side effects the night of 3-17-2021. She reports side effec... Read more
Patient reports that she starting having side effects the night of 3-17-2021. She reports side effects of nausea, headache, body aches. Woke up in the morning of 3-18-2021 and had trouble seeing, felt dizzy. Blood pressure was lower at 115/54 pulse 80. This did resolve over the next few hours.
66 2021-03-17 transient ischaemic attack Fever, joint pain and a trip to ER with TIA between 24-48 hours of vaccine
66 2021-03-18 blood pressure increased, chest discomfort Severe pain/ pressure in temples,eyes,back of the head. Blood pressure spike,red on chest, heaviness... Read more
Severe pain/ pressure in temples,eyes,back of the head. Blood pressure spike,red on chest, heaviness in chest and bile in throat, coughing, shallow breathing. Pain in temples tarted 5min after shot chest issues 25 mins later. Paramedics, ekg, iv, shot to bring down pressure, Benadryl in iv. Hospital 60mg of Prednisone and 20 mg Benadryl and kept me for observation.
66 2021-03-18 blood pressure increased Within 5 min of receiving the vaccine injection, pt complained of being dizzy. EMT's on site took BP... Read more
Within 5 min of receiving the vaccine injection, pt complained of being dizzy. EMT's on site took BP and found it to be significantly elevated. EMT's called the local clinic and spoke to the PA on duty. They advised the EMT's to transport the pt to the hospital for treatment.
66 2021-03-18 chest discomfort, blood pressure increased Patient was observed for 30 minutes and she left. She returned a short time later and reported feeli... Read more
Patient was observed for 30 minutes and she left. She returned a short time later and reported feeling flush and a bit of chest and throat tightness. Stated having many trips to the ER in the past for anaphylaxis, she no reaction to her first dose and says her allergist told her she was safe to receive the second dose. We sent her to the ER following her elevated blood pressure and assessment of her swollen hard/red injection spot.
66 2021-03-18 heart rate irregular 2/1/2021, on the 6th day from the time of the vaccination, at approximately 7:00 I began having a se... Read more
2/1/2021, on the 6th day from the time of the vaccination, at approximately 7:00 I began having a severe headache and my heart rate was on and off irregular. I could only sleep partial sitting to keep heart in regular. 2/2/2021: Next morning, okay but tired, but went to work. work at desk with computer. That evening, I began having severe breakouts like hives -hot, burning, itching, swelling. Started under the breast with a large red circle and then on lower stomach, lower back. Next day, 2/3/2021. breakout under breast still evident red and painful; breakout moved to other parts of body now breakouts are on inside of thigh and lower leg. Continue with Benadryl. Helps with itching but does not stop the breakouts. 2/4/2021: - Continue with breakouts. Some get better, go away but some continue. That night began swelling in roof of mouth, hot and painful and right side of throat (inside). Went to Emergency room Doctor said continue with Benadryl and see primary doctor. 2/5/2021: - Breakouts continue but changes somewhat. Now affecting joints. Hot, red, swelling, itching palm of hands, some finger joints and back of hands. Bottom of feet & sides, and ankles. Side of knees, elbows. Continue with Benadryl. Helps some with anti-itch cream. 2/6/2021 + - Continue with breakouts. Rash on arm where vaccine shot was administered. Breakout Rash and swelling under arm both arms and other parts of body. 2/16/2021? Appoint with Cardiologist, Dr. Begin medication for irregular heart rate. Metoprolol Tartrate 25 mg. 1 x day. Continue with breakouts. 3/4/2021: Appoint with allergy specialist, Dr., Allergy. She prescribed Cetirizine 10 mg 2 x day, Famotidine 20 mg 2 x day. Begin medications. Very helpful swelling went down in hands and feet. Breakouts stopped. 3/6/2021: Breakouts start again but very small areas; 3/9/2021? hot itching, knotty areas on buttocks, inside of knee. As of 3/19/2021 (date of this report) Continue to have painful breakouts in various places? Intense varies. Return to allergy specialist 4/1/2021 for appointment.
66 2021-03-18 fainting 30 days after my second shot. I am experiencing chills, fever, headaches, joint pain, sweating, a we... Read more
30 days after my second shot. I am experiencing chills, fever, headaches, joint pain, sweating, a week of fatigue, dizziness and fainting. 48 hours of chill fever headaches joint pain. 24 hours of dizziness and fainting.
66 2021-03-18 fainting Afraid husband may found her on the floor; Hardly can walk; So weak; Dizziness; Diarrhea; Vomiting; ... Read more
Afraid husband may found her on the floor; Hardly can walk; So weak; Dizziness; Diarrhea; Vomiting; Fever; Headache; A spontaneous report was received from a sixty-six-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, diarrhea, vomiting, fever, headache, hardly can walk, so weak, afraid husband may found her on the floor. The consumer's medical history was not provided. No relevant concomitant medications were reported. On 26 Jan 2021, prior to the onset of the events the consumer received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the consumer experienced the events dizziness, diarrhea, vomiting, fever, headache, hardly can walk, so weak, afraid husband may found her on the floor. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events was unknown. The assessment for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
66 2021-03-18 fainting Discomfort. Body and Muscle aches. Nausea, vomiting, headache, fever, chills, abdominal pain, light ... Read more
Discomfort. Body and Muscle aches. Nausea, vomiting, headache, fever, chills, abdominal pain, light headedness followed by fainting.
66 2021-03-19 arrhythmia Approximately 3 days post vaccine I began to have severe tinnitus. On the same day, I began to have ... Read more
Approximately 3 days post vaccine I began to have severe tinnitus. On the same day, I began to have difficulty with my vision , especially in the left eye, a headache and all my joints began to ache. I was also very tired. The symptoms progressively got worse over the following two weeks and included a couple of episodes of heart rhythm irregularities . During the third week, the headache, eye issues and joint pain began to resolve but the tinnitus is debilitating and prevents me from mentally focusing or sleeping.
66 2021-03-19 atrial fibrillation next morning woke with fevers, body aches, chills, nausea and headaches. today diagnosed with new o... Read more
next morning woke with fevers, body aches, chills, nausea and headaches. today diagnosed with new onset atrial fibrillation and LLL pneumonia.
66 2021-03-19 blood pressure increased Very spiked blood pressure, nausea, flushed, dizziness, sore arm, ended up in ER.
66 2021-03-19 loss of consciousness Loss of consciousness @ 6.5 hrs post vac Severe headache, chills, fever, and vomiting from 8 to 26 h... Read more
Loss of consciousness @ 6.5 hrs post vac Severe headache, chills, fever, and vomiting from 8 to 26 hours post vac.
66 2021-03-20 chest discomfort One day after receipt of vaccine, had extreme pain in left arm (the injection arm) from top of shoul... Read more
One day after receipt of vaccine, had extreme pain in left arm (the injection arm) from top of shoulder to elbow. Pain felt like I was having a bursitis attack with a pain level of 7 out of 10. Took two days to get to a "2". Did not sleep for two nights. Extreme "fogginess" in head, numb feeling around nose, mouth and eyes. Fatigue, depression, sadness . Anxious feeling in the chest which is continuing as of this writing (3/21/21) I do not take any medications and do not have any history of depression or mental illness. This is all very unusual for me.
66 2021-03-21 hypotension Patient received Moderna vaccine ~2pm, by the evening, had developed fatigue, with low blood pressur... Read more
Patient received Moderna vaccine ~2pm, by the evening, had developed fatigue, with low blood pressure. Patient required admission to the ICU with vasopressor support, which was able to discontinue after ~3 days. Patient reports no other symptoms. Fatigue persisted until mid-March.
66 2021-03-21 low blood oxigenation Hypokalemia Hypoxia Fever Pneumonia due to COVID-19 virus COVID-19
66 2021-03-22 lightheadedness Mon-Tues 9:00pm-6:00am - paralyzed on back in full body pain, literally unable to move AT ALL Tues-W... Read more
Mon-Tues 9:00pm-6:00am - paralyzed on back in full body pain, literally unable to move AT ALL Tues-Wed 6:00am-5:00am (next day) - able only to roll onto side; unable to get up except 2-3 times to bathroom; almost passed out one time; unable to keep down even sips of water; dry heaves; 100.8 fever; chills/fever; severe headache Wed-Sat - severe exhaustion; out of bed only occasionally and very briefly; able to keep down a little broth and then chicken soup; periodic chills, headache, nausea Sun-Mon - a little more improvement in all areas Tues - much better! At some point, I developed Livedo reticularis in left calf. Went to urgent care on March 19. EKG normal. No DVT. Possibly caused by spasm. Saw physician today March 23. Cause undetermined.
66 2021-03-23 loss of consciousness while taking blood pressure patient passed out; not feel well; fever; aches; headache; chills; A spo... Read more
while taking blood pressure patient passed out; not feel well; fever; aches; headache; chills; A spontaneous report was received from a nurse concerning a 66-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, aches, headache, chills, did not feel well and passed out. The patient's medical history included atrial fibrillation following symptoms of feeling sick, headache and chest discomfort in September 2020. Current conditions included elevated blood pressure (BP) and a shrimp/shellfish allergy. Concomitant medications included apixaban, carvedilol, lisinopril and vitamin D. On 04 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 013M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, one day after receiving the vaccine, the patient experienced fever, aches, headache and chills. She took paracetamol and felt better. On that same day at approximately 1330, 24 hours after the vaccine, the patient was preparing a sandwich and was not feeling well. She sat in a chair to take her blood pressure and passed out. At some point, it was reported that patient was admitted to the hospital for a five-day stay. (admission/discharge dates not reported). Treatment for the events included paracetamol. There was not change planned to the dosing schedule of mRNA-1273 in response to the events as it is known that on 05 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Batch Number: 002A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection. The outcome of the events, fever, aches, headache, chills, not feel well and passed out, was considered recovered/resolved on an unspecified date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
66 2021-03-23 transient ischaemic attack Pin Stroke; A spontaneous report was received from a consumer concerning a 66-year-old, female pati... Read more
Pin Stroke; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event pin stroke. The patients medical history was not provided. Products known to have been used by patient with in last two weeks included montelukast , alendronate and varenicline tartrate. On 04-Mar-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: 010A21A ) through intramuscular route of administration in the left deltoid for prophylaxis of COVID-19 infection. On 06-Mar-2021, patient experienced pin stroke and was hospitalized for four days. Laboratory tests performed included magnetic resonance imaging and electro cardiogram and the results was not provided. No treatment information was provided.. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event pin stroke was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
66 2021-03-24 chest pain Thank you for the ability to receive the vaccine, I am reporting this for your documentation. 11:... Read more
Thank you for the ability to receive the vaccine, I am reporting this for your documentation. 11:00 very tired , followed by chills and body aches especially chest pains. 2:00 pm upset stomach , 6:00 pm started throwing up for 90 mins. Tuesday still had chills and body aches foggy thinking could eat later in the day. I have a big bruise on my arm still 10 days later and a line of 4 blood blisters at my injection site . I have pictures did not see where I could up load them. My partner (67) was great on Monday after the shot.. did 5 miles on the treadmill. Tuesday he had a low grade fever 101, severe chills and body aches. Wednesday we were both still a little foggy . Other than than great
66 2021-03-24 hypertension, heart rate irregular Vaccine 3/4/21. 2nd day extreme tiredness for 2 days; then weak, dizzyish, tremors, blurred vision r... Read more
Vaccine 3/4/21. 2nd day extreme tiredness for 2 days; then weak, dizzyish, tremors, blurred vision right eye which is near legally blind, poor concentration, generally poor feeling. These symptoms went on for 2 weeks, until I had to do my routine lithium level on 3/18/21. I was toxic at 1.7. Have been on lithium 40 years and have never been toxic. My doctor sent me to ER, where they gave me fluids and potassium. When checked in ER, my BP was 214/87. I never have high BP - 120/80 is normal. On discharge, my BP was 194/79. Saw my doctor ASAP on advice of ER. My doctor put me on amlodipine for BP which I started today. He said I had essential hypertension and heart rate is irregular.
66 2021-03-25 blood glucose increased, hypotension blood sugar 300-500 low blood pressure 70/54 headache pain in right leg llimited mobility right arm ... Read more
blood sugar 300-500 low blood pressure 70/54 headache pain in right leg llimited mobility right arm painful ;limited memory clamy feeling sweaty
66 2021-03-25 cerebrovascular accident Symptoms: tingling on right side of body--face, arm and hand, foot First event on 3/22/2021 starting... Read more
Symptoms: tingling on right side of body--face, arm and hand, foot First event on 3/22/2021 starting at about 4:15 pm, lasted about 15 minutes Second event on 3/23/2021 starting at about 10:15 am, lasted over an hour. Went to ER during this event; had additional tingling on site in the ER.
66 2021-03-26 chest pain, ischemic chest pain, palpitations I am in pain in all my joints bones and muscles, headache, high fever, chills, shakey,/ trimbling, ... Read more
I am in pain in all my joints bones and muscles, headache, high fever, chills, shakey,/ trimbling, can't get warm, Nauseated, Weak, arm swollen very painful, but the most concerning is I am having left inner chest palpitations of my heart, and pain like my heart muscel is knoting up, hurts through my chest to my left back under my shoulder blade...I am so weak, I can hardly walk. I have been in bed, pain so bad I can not sleep much...I did eat cereal but made more nauseated.
66 2021-03-26 heart rate increased Moderna COVID-19 Vaccine EUA Fast heartbeat that night when I went to bed. Before that I had little ... Read more
Moderna COVID-19 Vaccine EUA Fast heartbeat that night when I went to bed. Before that I had little sharp pains in different areas of my body. I could not sleep for 3 nights. I was very tired, but just couldn't go to sleep. After having those side effects, I do not want to take the second vaccine shot, which is due on April 9th.
66 2021-03-27 hypertension Head ack,Dizzy,Fever 102,nausa,Tired Blood pressure High 201 over168,weak,red arm swollen hot sore.
66 2021-03-27 palpitations chills, fatigued, headache, body aches, heart racing
66 2021-03-28 fast heart rate Dose 1: Onset of symptoms Day 9 at approx noon. Itching at the injection site, reddening, hardness. ... Read more
Dose 1: Onset of symptoms Day 9 at approx noon. Itching at the injection site, reddening, hardness. 3" circular. Seen by Urgent Car physician to rule out cellulitis, which symptoms are very similar. Symptoms increased overnight to bright red, very sore, less itchiness (Photo available.) Brain fog for about 2 days. Fatigue for 2-4 days. Some joint/body soreness. Dose 2: 10:00 jab - 14:30 out like a light for 1h15m. 23:00 bed - very sore arm. 01:00 awake, restless all night, with tachycardia & possibly a fever but I did not take it. Finally slept at 7am for 3 solid hours of sleep. Headache on waking; Tylenol worked well. Site of inoculation had slight redness and swelling and was sensitive to the touch for 4-5 days. Not nearly as red as Dose 1 reaction. By day 6 itching recurred across whole area. Day 7 slightly sensitive to the touch.
66 2021-03-29 blood glucose increased Blurred vision on 2/23/21 blood sugar level 366 High blood sugar on 2/18/21 went up to 335 High blo... Read more
Blurred vision on 2/23/21 blood sugar level 366 High blood sugar on 2/18/21 went up to 335 High blood sugar on 3/02/21 went up to 366 High blood sugar on 3/08/21 went up to 455. Emergency visit to Hospital with tremors Treated with insulin and went back home with 280 sugar level. High blood sugar on 3/10/21 at 345 level. visited doctor High blood sugar on 3/15/21 at 198 level. visited doctor High blood sugar on 3/21/21 at 153 level. Blurred vision High blood sugar on 3/22/21 at 159 level. Blurred vision . Visited eye doctor Right now sugar level went down to 131. Have future doctors' visits
66 2021-03-29 blood pressure increased, palpitations Felt like heart was racing about 30 minutes after vaccination. BP 165/82 HR 101 and sats 99%. State... Read more
Felt like heart was racing about 30 minutes after vaccination. BP 165/82 HR 101 and sats 99%. Stated a little higher but not unusual. Felt okay to go home. Observed for 30 minutes.
66 2021-03-29 hypertension Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Inject... Read more
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Hypertension-Medium, Error: Infection / Cellulitis (diagnosed by MD)
66 2021-03-29 lightheadedness, chest pain Patient presents for pre-syncope and then subsequent development of chest pain. She was in therapy w... Read more
Patient presents for pre-syncope and then subsequent development of chest pain. She was in therapy when she had to use the restroom. She was urinating and having a BM when she suddenly felt extremely lightheaded as though she were about to lose consciousness. She did not thankfully lose consciousness, but rather rapidly developed chest pain after this event. She was brought to ED for evaluation. COVID screen in ED is positive. She was infected with COVID in November, 2020. She has since had a negative COVID screen. She is now positive again >90 days after first positive test, thus this will be treated as a new COVID infection. Place in negative pressure room. I am inclined to begin. Remdesivir as patient is always at high risk for progression to severe disease. 11/11/2020 positive COVID-19 2/13/2021 negative COVID-19 3/29/2021 positive COVID
66 2021-03-29 fainting Rash, dizziness, syncope, fever/chills, nausea, hives, fatigue. Went to ER received Benadryl, and e... Read more
Rash, dizziness, syncope, fever/chills, nausea, hives, fatigue. Went to ER received Benadryl, and epinephrine, methyl prednisone inj, pepcid inj. rested and continued Benadryl and prednisone for 5 days. Now feeling good.
66 2021-03-30 ischemic chest pain bell's palsy; wrinkles in right eye was very smooth; patient nerves felt like little electricity lin... Read more
bell's palsy; wrinkles in right eye was very smooth; patient nerves felt like little electricity lines zapping through constantly/still feels like cranial 7 nerves are on fire; most severe ice pick headache/headaches happened in bed while laying down/headaches feel dangerous; heart muscle is a little sore; felt like the biggest wasp in the world stung her head; painful cranial nerve felt like it was on fire (5minutes)/still throbbed a little/hot lava runnign through that nerve for 20 minutes/still nerve pain; afraid to go to sleep; sore arm; A spontaneous report was received from a consumer concerning a 66 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, severe ice pick headache, felt like the biggest wasp in the world stung her head, nerve pain, afraid to go to sleep, most severe ice pick headache/headaches happened in bed while laying down/headaches feel dangerous, patient nerves felt like little electricity lines zapping through constantly/still feels like cranial 7 nerves are on fire, bell's palsy, wrinkles in right eye was very smooth, patient feels pressure in her brain/scared there may be swelling in her brain and heart muscle is a little sore. The patient's medical history included COVID-19 and concomitant medication included Vitamin B12. On 24-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly on left deltoid for prophylaxis of COVID-19 infection. On 25-FEB-2021, one day after receiving mRNA-1273, patient started to experience sore arm. On 26-FEB-2021 patient had severe severe ice pick headache, it felt like the biggest wasp in the world stung her head. She states that it was so painful, and it scarred her. Patient claims she searched it up and it was the cranial 7 nerve from her temple to the back of her head that was on fire which lasted for 5 minutes. The next day 27-FEB-2021 patient states the headache was gone however the nerve still throbbed a little and she was afraid to go to sleep that night. She then woke up that same night with severe ice pick headaches that were slamming into her head. On 28-FEB-2021 the patient took protective measures and got up early and did not experience anything on that day. On 1-MAR-2021, she accidentally touched her husband's forehead with her head lightly and had the most severe ice pick headache (like hot lava running through that nerve for 20 minutes). It alleviated when she took two Advil's. The next morning 2-MAR-2021 the patient nerves felt like little electricity lines zapping through constantly. Patient had looked up Bell's Palsy within our clinical trials and when she went to the doctors on 3-MAR-2021, they said the wrinkles in the right eye was very smooth compared to the left but her eyes were not drooping), doctors believed it to be Bell's palsy and prescribed her Gabapentin, and Zovirax. Since then her ice picks have left but there is still nerve pain. She feels like the cranial 7 nerves are still on fire. All her headaches happened in bed while laying down. Patient states that the headaches feel dangerous and feel like they will cause her permanent damage. Patient still feels pressure in her brain and is scared there may be swelling in her brain. Treatment medications included Advil, Gabapentin, and Zovarax. Seriousness criteria included medically significant events. Action taken with mRNA-1273 in response to the events was not reported. Outcome of the event sore arm, severe ice pick headache, felt like the biggest wasp in the world stung her head, nerve pain, afraid to go to sleep, most severe ice pick headache/headaches happened in bed while laying down/headaches feel dangerous, patient nerves felt like little electricity lines zapping through constantly/still feels like cranial 7 nerves are on fire were considered recovered but bell's palsy, wrinkles in right eye was very smooth, patient feels pressure in her brain/scared there may be swelling in her brain and heart muscle is a little sore were considered unknown.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events and excluding all other etiology, a causal relationship cannot be excluded. Headache is consistent with the known safety profile of he vaccine.
66 2021-03-30 chest pain, palpitations, chest discomfort Chest discomfort, pain and pressure, heart palpitations, fever and chills, shortness of breath, achi... Read more
Chest discomfort, pain and pressure, heart palpitations, fever and chills, shortness of breath, aching joints, fatigue, dizziness, weakness, and headache and neck. Hydration and Tylenol and rest ~ was considering going to the ER. Symptoms persisted throughout the night. The next morning weakness and muscle aches continued but are gradually subsiding.
66 2021-03-30 heart rate increased Sore, hot arm; nausea; some vomiting; horrible headache; fatigue; sleep tired; achy; on 03/19/2021 m... Read more
Sore, hot arm; nausea; some vomiting; horrible headache; fatigue; sleep tired; achy; on 03/19/2021 my heart rate was around 180
66 2021-03-30 heart rate increased Constricted airway, unable to breathe, weak, loss of speech, increased heart rate, fatigue, loss of ... Read more
Constricted airway, unable to breathe, weak, loss of speech, increased heart rate, fatigue, loss of balance
66 2021-03-30 loss of consciousness Pt called today, one day after getting her second moderna vaccine, stating that she was feeling naus... Read more
Pt called today, one day after getting her second moderna vaccine, stating that she was feeling nauseas and passed out. She states she has a history of passing out when feeling nauseas. She was concerned that the vaccine caused her to pass out. I explained to her that based on her history, that I did not think the vaccine caused her to pass out. Encouraged her to reach out to her health care provider if she was concerned.
66 2021-03-30 pallor About 8/9 days after first shot I noticed a pale pink/red rash on arm around injection sight. The r... Read more
About 8/9 days after first shot I noticed a pale pink/red rash on arm around injection sight. The rash was about 3 x 2 inches in size and maintained the same light color for duration. I applied Benadryl cream 2 days after noticing rash and the rash lightened and went away.
66 2021-03-31 deep vein blood clot right upper extremity DVT. Symptoms began 5 days after receiving vaccine. Presented with right arm... Read more
right upper extremity DVT. Symptoms began 5 days after receiving vaccine. Presented with right arm redness and swelling. Found to have DVT on Day 9 following vaccination. Does have a previous history of provoked DVT (following leg fracture). No known coagulation disorder and not on chronic anticoagulation.
66 2021-03-31 hypertension Right side of mouth dropped; Diagnosed with paresthesia; Numbness in her cheek, tongue, jaw and head... Read more
Right side of mouth dropped; Diagnosed with paresthesia; Numbness in her cheek, tongue, jaw and head on the right side; Slurring; Blood pressure shot up; Bad headache; A spontaneous case was reported by a consumer concerning a 66-year-old female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced the following: diagnosed with paresthesia (paraesthesia), numbness in her cheek, tongue, jaw and head on the right side (hypaesthesia), right side of mouth dropped (facial paralysis), slurring (dysarthria), blood pressure shot up (hypertension) and bad headache (headache). The patient's past medical history included stroke (she had stroke about 7 years ago). Concomitant products included blood pressure medication (not otherwise specified). On 16-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Batch no. 031L20A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection. On 16-Feb-2021, within one minute after receiving the vaccine, the patient experienced numbness in her cheek and tongue on the right side. The numbness moved to her jaw and head and she also had slurring. The right side of her mouth dropped, her blood pressure shot up, and she had a bad headache. The patient was taken to the emergency room (ER) and diagnosed with paresthesia and also treated for stroke symptoms. The patient was in the hospital from about 10:30-5:00 pm. Treatment included aspirin and IV. The recommendation was made for the patient to take atorvastatin, but the patient was not taking it. The patient went to see her physician on 22-Feb-2021. At the time of this report, the patient's side effects had not completely resolved. The action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, diagnosed with paresthesia, numbness in her cheek, tongue, jaw and head on the right side, right side of mouth dropped, slurring, blood pressure shot up, and bad headache, was considered not recovered/not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. The patient's past medical history of stroke and ongoing history of hypertension remains a confounder.
66 2021-03-31 loss of consciousness passed out; fall; Lower back pain; fever up to 102 F; Chills; nauseous; Head hurts; A spontaneous re... Read more
passed out; fall; Lower back pain; fever up to 102 F; Chills; nauseous; Head hurts; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who experienced fever (pyrexia), chills, nausea and had passed out (loss of consciousness). The patient's medical history was not provided. Concomitant medications were not provided. On 28-FEB-2021, the patient received their first of two planned doses of mRNA-1273(Lot number- 012A21A) in the left arm for prophlaxis of Covid-19 infection. On 01-Mar-2021, the patient experienced fever, chills, nausea and had passed out when she went to the bathroom. When she woke up, she was on her bed and reported that her lower back and head hurts after that fall. Treatment medications included acetaminophen for fever and chills. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events of fever (pyrexia), chills, nausea and passed out (loss of consciousness) resulting in fall and head and back hurts thereafter were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
66 2021-03-31 platelet count decreased 66-year-old woman with a past medical history of rheumatoid arthritis, fibromyalgia, hypertension, h... Read more
66-year-old woman with a past medical history of rheumatoid arthritis, fibromyalgia, hypertension, hyperlipidemia, GERD and recent COVID-19 vaccination who presented from home with vomiting and altered mental status. Patient was reportedly in her usual state of health until receiving her second COVID-19 vaccination on 3/24/2021. She reportedly developed the above symptoms and her son called 911. She was brought to the ED for further evaluation and management. In the ED, routine vital signs were obtained which revealed patient was febrile to 103.6, heart rate 80, respiratory 18, blood pressure 116/73, O2 saturation 91% on room air. Routine labs were obtained which revealed a normal CMP with the exception of a GFR 47, creatinine of 1.2, lactic acid 1.8, white blood cell count 6.1, hemoglobin 12.2 and platelet count of 144. Urinalysis was obtained and was suspicious for UTI. Rapid influenza and COVID-19 antigen were both NEGATIVE. Blood cultures were drawn in the ED. Chest x-ray revealed a suspicion for infiltrate involving the right upper lung and right perihilar region. CT of the head no acute findings. Patient was felt to have signs and symptoms consistent with pneumonia, and received IV azithromycin and ceftriaxone. Follow up chest xray the following day showed resolution of the right upper lobe findings arguing against pneumonia. Antibiotics were stopped and the patient was discharged home after a 1 day stay.
66 2021-04-01 very slow heart rate, hypertension 66 year old female to with dizziness & hypertension during post vaccination observation period. Ta... Read more
66 year old female to with dizziness & hypertension during post vaccination observation period. Taken to ED with dizziness, lightheaded, hypertension & bradycardia, given hydralazine IV & Norvasc (orally) . COVID & flu testing negative. Improved & discharged to home.
66 2021-04-01 coughing up blood I feel tired; Arm is still swollen; Spitted and saw blood; Choking; Coughing; Red arm; A spontaneous... Read more
I feel tired; Arm is still swollen; Spitted and saw blood; Choking; Coughing; Red arm; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who experienced choking, coughing, spitted blood/hemoptysis, fatigue, arm redness/injection site erythema and swelling of arm/injection site swelling. The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the events were atorvastatin, aspirin, Lipitor, water pills and vitamin D3. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) in the left non-dominant arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, the patient received their second of two planned doses of Mrna-1273 (Lot number: 012M20A) in the left non- dominant arm for prophylaxis of COVID-19 infection. After the second dose, the patient experienced arm redness. On 25 Feb 2021, the patient experienced choking, coughing and spitted out blood, which was experienced on 26 Feb 2021 morning as well. Later, on 26 Feb 2021 the patient developed swollen and reddish arm and fatigue. No such symptoms were experienced after first dose. Treatment for the event was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, choking, cough, hemoptysis, fatigue, injection site erythema and injection site swelling were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
66 2021-04-01 hypotension about 2 hours later I started having allergic reactions similar to ones I have had in the past with ... Read more
about 2 hours later I started having allergic reactions similar to ones I have had in the past with food allergies. My bottom lip started swelling, my tounge swelled, I took Benedryl which reduced the swelling but I was very tired, lighheaded, blurry vision, Brain fog could not perform normal duties, rested most of the rest of the day. The next day I still was not comfortable driving as I was still feeling lighheaded. I have Vasovagel syncope where my blood pressure drops, even 7 days later I still felt ligh headed and in the mornings my calfs burn. 7 days later blood pressure was low 94/61 and 97/59. Its now 10 days later and I still do not feel 100%. my Cardiologist recommended extra salt intake and not to take 2
66 2021-04-01 loss of consciousness patient was seated and experiensed lost of conciousness. moved patient on to floor with legs elevat... Read more
patient was seated and experiensed lost of conciousness. moved patient on to floor with legs elevated. patient came to and recovered
66 2021-04-01 lightheadedness Pt became dizzy post vaccination, had a near syncopal episode, BP 123/68, HR 60 Blood sugar 68. Afte... Read more
Pt became dizzy post vaccination, had a near syncopal episode, BP 123/68, HR 60 Blood sugar 68. After a snack nad rest she felt better and was able to go home
66 2021-04-02 chest discomfort Light tingling of my tongue while waiting after vaccine. I was given water and then waited addition... Read more
Light tingling of my tongue while waiting after vaccine. I was given water and then waited additional time. Seemed better so we left. About 45 min to an hour after injection I started getting a warm feeling in my chest. It lasted about an hour. The next day in p.m. I was very tired and my arm hurt. When I got ready for bed I noticed that at the injection site it was red , a little swollen , itchy and painful. The next day It was the same but more red. I put ice on it throughout the day which helped some.
66 2021-04-03 palpitations 1st dose 2/19 - some left arm pain, difficulty sleeping on the left side; 2nd dose 3/19 - fever (up ... Read more
1st dose 2/19 - some left arm pain, difficulty sleeping on the left side; 2nd dose 3/19 - fever (up to 100.5)and chills, stomach pain, nausea, felt miserable for approximately 30 hours. Got better, since them, ever so often, fatigue, some pain, nothing out of ordinary; on 4/2 (3 weeks after 2nd dose), woke up in the middle of the night, with palpitations, dizziness, nausea, chills. Called 911 thought was having a heart attack. Labs at ER were fine. I still feel lots of fatigue and chills (no fever). Per ER not an MI or Stroke, maybe a panic attack. Never had anything like that, still feel nauseated, lack of appetite and chills. Difficulty sleeping since the first dose.
66 2021-04-04 nosebleed Blisters on nose (inside some and all around nostrils on outside), sores on roof of mouth, tongue, a... Read more
Blisters on nose (inside some and all around nostrils on outside), sores on roof of mouth, tongue, and on some gums. Very thick post nasal drip, yet dry parts when blow nose, with some blood. Using Abreva and saline spray.
66 2021-04-05 anaemia, cerebrovascular accident Pt presented to the ER on 2/26 with hemorrhagic CVA basal ganglia, left sided hemiparesis, dysarthri... Read more
Pt presented to the ER on 2/26 with hemorrhagic CVA basal ganglia, left sided hemiparesis, dysarthria, WBC elevated to 19,000, platelets elevated 568,000, new anemia, CRP markedly elevated
66 2021-04-05 hypertension I had the same arm issues, along with an unusual feeling in my head. My BP was higher than it's ever... Read more
I had the same arm issues, along with an unusual feeling in my head. My BP was higher than it's ever been at 184/88. I started seeing a gray area in the eye where I had my surgery and the doctor discovered that my retina was detached. I also had a red, blotchy area on my face. He said the increased BP could?ve caused it. I had to undergo surgery twice after that. They reattached it, but I had scar tissue so it became detached again. They?re waiting for it to stop creating scar tissue before they try again.
66 2021-04-05 loss of consciousness passed out; couldn't move; threw up; joint pain; headache; hives; high fever; This case was received... Read more
passed out; couldn't move; threw up; joint pain; headache; hives; high fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Urticaria (chronic hives for 16 years.) since an unknown date. Concomitant products included DOXEPIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (high fever). On 19-Feb-2021, the patient experienced URTICARIA (hives). On 19-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MOVEMENT DISORDER (couldn't move), VOMITING (threw up), ARTHRALGIA (joint pain) and HEADACHE (headache). On 19-Mar-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved. On 24-Mar-2021, MOVEMENT DISORDER (couldn't move), VOMITING (threw up), PYREXIA (high fever), ARTHRALGIA (joint pain) and HEADACHE (headache) had resolved. At the time of the report, URTICARIA (hives) outcome was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
66 2021-04-05 loss of consciousness PATIENT STATES SHE PASSED OUT THE FRIDAY AFTER GETTING VACCINATED. SAID SHE WAS GETTING READY IN TH... Read more
PATIENT STATES SHE PASSED OUT THE FRIDAY AFTER GETTING VACCINATED. SAID SHE WAS GETTING READY IN THE MORNING AND WAS ABOUT TO BRUSH HER TEETH WHEN IT HAPPENED, BUT THAT SHE WAS ABLE TO CATCH HERSELF FROM FALLING. ALSO STATES HER ARM WAS MORE PAINFUL, SWOLLEN AND RED THAN THE 1ST SHOT.
66 2021-04-06 chest pain Normal redness, swelling and itching first 72 hours, cleared up and returned 8 days later on March 3... Read more
Normal redness, swelling and itching first 72 hours, cleared up and returned 8 days later on March 31, joint swelling in elbow of Left arm, bruise showed up next to injection site, arm developed red swollen,itchy rash 1.5 inches below and right of the injection site, sore throat and ache in chest, mild fever 99.8, aches and pain in ears, joints, hands, knees over the next 72 hours. All mild, recurring and now resolved.
66 2021-04-06 loss of consciousness I passed out; dizziness; I was out; I was sweating profusely; This spontaneous case was reported by ... Read more
I passed out; dizziness; I was out; I was sweating profusely; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (I passed out) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no medical history reported). On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (I passed out) (seriousness criterion medically significant), DIZZINESS (dizziness), FEELING ABNORMAL (I was out) and HYPERHIDROSIS (I was sweating profusely). At the time of the report, LOSS OF CONSCIOUSNESS (I passed out), DIZZINESS (dizziness), FEELING ABNORMAL (I was out) and HYPERHIDROSIS (I was sweating profusely) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications provided. No treatment information provided. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
66 2021-04-07 deep vein blood clot Diagnosed with a dvt blood clot in my left leg on 04/02/2021. On eliquis and warfarin.
66 2021-04-08 hypotension Started about 12 hrs after injection: unable to sleep but sleepy, nauseas, migraine right eye affec... Read more
Started about 12 hrs after injection: unable to sleep but sleepy, nauseas, migraine right eye affected, body ake, dizziness, and itchy in the morning my throat started hurting and tongue swelling, gums and teeth hurt, right fingers swelled, under right arm lymph nodes hurt, painful to touch, liver tender and bladder gave way- (urgency without notice) first time peeing in pants! Took blood pressure and very low reading . Started to feel like a human being again on April 2nd.
66 2021-04-09 cerebrovascular accident stroke; light headed; This spontaneous case was reported by a consumer (subsequently medically confi... Read more
stroke; light headed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included CML (CML Leukemia though she's in remission now) in 1999 and Surgery (Open eye surgery (2 & half year ago)). Concurrent medical conditions included Prediabetes, Blood pressure (Taking medication for blood pressure) and Renal disorder NOS (Taking medication for her kidneys). Concomitant products included METOPROLOL for BP, ATORVASTATIN for Cholesterol, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)). On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and life threatening). On 05-Apr-2021, the patient experienced DIZZINESS (light headed). The patient was hospitalized from 20-Mar-2021 to 23-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) had resolved and DIZZINESS (light headed) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment of these events were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's past medical history of CML, hypertension, Hyperlipidemia may contribute to this event. Further information is requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's past medical history of CML, hypertension, Hyperlipidemia may contribute to this event. Further information is requested.
66 2021-04-09 loss of consciousness Arm kept getting more red and more swollen so she was told to go to the emergency clinic; Arm starte... Read more
Arm kept getting more red and more swollen so she was told to go to the emergency clinic; Arm started turning red and swelling; Very sick; Bad headache; Nausea; Fever; Passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), ERYTHEMA (Arm kept getting more red and more swollen so she was told to go to the emergency clinic) and PERIPHERAL SWELLING (Arm started turning red and swelling) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chemotherapy. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), ERYTHEMA (Arm kept getting more red and more swollen so she was told to go to the emergency clinic) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Arm started turning red and swelling) (seriousness criterion hospitalization), ILLNESS (Very sick), HEADACHE (Bad headache), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), ERYTHEMA (Arm kept getting more red and more swollen so she was told to go to the emergency clinic), PERIPHERAL SWELLING (Arm started turning red and swelling), ILLNESS (Very sick), HEADACHE (Bad headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Products known to have been used by the patient, within two weeks prior to the event, included chemotherapy. Treatment for the event included ice, cortisone, 4x iv antibiotics and oral antibiotics. Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-062175, MODERNATX, INC.-MOD-2021-062175 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-062175:Crosslinked case MODERNATX, INC.-MOD-2021-062175:Crosslinked case
66 2021-04-10 loss of consciousness, hypotension COVID-19; Passed out; Diarrhea; Dizziness; Weakness; Low blood pressure; This spontaneous case was r... Read more
COVID-19; Passed out; Diarrhea; Dizziness; Weakness; Low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No relevant medical history provided). On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weakness) and HYPOTENSION (Low blood pressure). On 26-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weakness), HYPOTENSION (Low blood pressure) and COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, COVID-19 (positive-negative): positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment was given intravenous bamlanivimab monoclonal antibodies therapy in the emergency room Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of Covid-19 and the product use is assessed as unlikely. The remaining events are assessed as a symptom of the disease and also assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of Covid-19 and the product use is assessed as unlikely. The remaining events are assessed as a symptom of the disease and also assessed as unlikely related to mRNA-1273.
66 2021-04-11 deep vein blood clot Left calf pain & swelling on 1/28/21. Seen in ED on 1/28; diagnosis left calf DVT. Started double ... Read more
Left calf pain & swelling on 1/28/21. Seen in ED on 1/28; diagnosis left calf DVT. Started double dosing of Eliquis twice daily. Leg swelling increased and upper left leg began to swell. Seen in ED again on 1/3121; new ultrasound showed extensive clotting both lower and upper left extremity. Continued double dosing of Eliquis with no resolution of clots. Seen by cardiovascular surgeon on 2/10/21; new ultrasound showed continued extensive clotting, now in pelvis as well as entire left leg. Referred to Interventional Radiologist. Procedure performed on 2/12/21: TPA & heparin infused through popliteal vein for 24 hours/in the intensive care unit
66 2021-04-11 fainting Patient went to the bathroom and when she got back to the couch, she fainted and could not get back ... Read more
Patient went to the bathroom and when she got back to the couch, she fainted and could not get back up. Patient called her husband and he came home and helped her to lay down on the couch. Patient reports she was very weak. Patient has not told her doctor.
66 2021-04-12 chest discomfort Presented to clinic today for COVID 10 Moderna Vaccine, second injection. After about 15 mins of re... Read more
Presented to clinic today for COVID 10 Moderna Vaccine, second injection. After about 15 mins of reciving the vaccine pt felt slight pressure on the chest, retrosternal that resolved within few minutes. She denies associated sob, difficulty breathing. However, reports this kind of chest pressure "on and off." Reports that she felt as it had to release "gas" and felt better afterwards.
66 2021-04-12 palpitations Hypothyroid turned into hyperthyroid. Racing heart, weight loss, gritty eyes, double vision, tremor,... Read more
Hypothyroid turned into hyperthyroid. Racing heart, weight loss, gritty eyes, double vision, tremor, nightmares. All began after January 25. Although TSH level was high, endocrinologist cut back synthroid because of symptoms. Now, 4 weeks later, I feel better, but labs are still strange.
66 2021-04-12 blood clot Blood clot on middle joint of right hand pinky finger. Pressure bandage, heat, Advil. Decreasing in ... Read more
Blood clot on middle joint of right hand pinky finger. Pressure bandage, heat, Advil. Decreasing in size after 18 days.
66 2021-04-13 fainting 6 hours after the injection I had a very sore arm at the injection site, body and joint aches, and a... Read more
6 hours after the injection I had a very sore arm at the injection site, body and joint aches, and a slight temperature. The next morning, 21 hours after injection, I got very lightheaded, faint, tinnitus, and nausea. All of these side effects subsided 30 hours after injection. The following day I had lightheadedness, tinnitus, and nausea, which has persisted for 4 1/2 weeks. 18 hours after the injection I woke up in the night with a strange sensation of movement when I closed my eyes. On the fifth day after injection I had am intense spell of lightheadedness, tinnitus, nausea, shaky arms and legs, and localized right side head pain, so I went to see a nurse practitioner. All of my vital signs, blood work, and urine sample were normal. I was advised to stay hydrated and get plenty of rest. After 4 1/2 weeks the nausea is almost gone, however, I still have times of lightheadedness and tinnitus. I have had some sort of "spell" on 19 of 29 days since the injection. The side effects seem to be getting less intense and less frequent. I have not had issues with any of this in the past.
66 2021-04-13 fainting FIRST EVENT: I fainted while walking my dog on 01/25/2021, 11 days after first dose of the Moderna v... Read more
FIRST EVENT: I fainted while walking my dog on 01/25/2021, 11 days after first dose of the Moderna vaccine. I fell on the ground and hit my head. I had never previously fainted before. I injured my forehead, my nose, my knees and hands. I do not remember falling to the ground and I did NOT brace when falling. While fainting, I didn't realize I was falling. SECOND EVENT: In February, after the second dose of Moderna, I started getting strong pain and cramps in both legs in the calf muscles and my toes. I couldn't walk. Starting on 03/09/2021, the pain in the left left intensified and I went to the doctor. The doctor performed ultrasound and told me that I have inflammation of the veins in the calf muscle. I started blood thinner medication (Eliquis) on 03/10/2021 for four days. I also took Ibuprofen (3x600 mg daily) for 12 days and Celebrex for 10 days. Once the inflammation decreased, I stopped taking the medication. I had residual pain for three weeks. I no longer have pain.
66 2021-04-13 superficial blood clot Development of superficial thrombophlebitis left saphenous vein and dorsalis pedis vein.
66 2021-04-14 loss of consciousness sudden nausea, lightheadedness, passed out, severe chills, all over body aches; lasted several hou... Read more
sudden nausea, lightheadedness, passed out, severe chills, all over body aches; lasted several hours; recovered at home
66 2021-04-14 loss of consciousness Severe chills. Shaking on night of injection date, dizziness and passing out several times the next ... Read more
Severe chills. Shaking on night of injection date, dizziness and passing out several times the next morning, severe fatigue, right breast and axillary pain persisted until 4/10/21. Also had hardened itchy lump a few days after injection near injection site with a few red bumps.
66 2021-04-14 palpitations This report is an update on case # 399798. After receiving the second dose of the Moderna COVID 19 v... Read more
This report is an update on case # 399798. After receiving the second dose of the Moderna COVID 19 vaccine, the patient reported an itchy rash all over body except her legs. On 4/4/21 she experienced dizziness that caused her to fall down the stairs. On 4/8/21 she reported not feeling well overall and her heart was racing, and her symptoms did not resolve when she ate.
66 2021-04-15 heart rate abnormal, fainting, blood pressure fluctuation, lightheadedness 04/06/2021 between 3:00 a.m. 9:45 a.m. Early morning hours at home experienced soreness in right arm... Read more
04/06/2021 between 3:00 a.m. 9:45 a.m. Early morning hours at home experienced soreness in right arm where injected, chills, body aches, nausea, lightheaded, dizziness, fainted and hit head on hall tree before hitting the floor. When conscious saw tooth on floor beside me , bruises to chin and inside mouth, two front teeth pushed back in mouth. Called dentist emergency, then periodontist who called 911 when I became lightheaded with fluctuating blood pressure and heart rate. Was taken by EMS to Medical Center. Seen by Dr. who diagnosed me with Vasovagal Near Syncope Collapse. Periodontist treatment plan includes 3 implants to replace/repair lost and displaced teeth..ongoing.
66 2021-04-16 oxygen saturation decreased, cardiac failure congestive On March 11 I had shortness of breath laying down. March 17 I was up all night with heart rate up t... Read more
On March 11 I had shortness of breath laying down. March 17 I was up all night with heart rate up to 125 and oxygen saturation as low as 80%. On March 18 I went to ER and was diagnosed with Congestive Heart Failure after a 3 day hospital stay of tests. I have no history of high blood pressure or heart issues except for high cholesterol controlled with Lipitor. No family history of heart problems. I am now on Entresto and Carvedilol.
66 2021-04-17 nosebleed Band of redness below injection site, itchyness still two weekd after injection. Unexplained am nos... Read more
Band of redness below injection site, itchyness still two weekd after injection. Unexplained am nose bleeds (two) since injection. About a week apart, they are easily stopped, but start while sleeping.
66 2021-04-18 hypertension expressive aphasia for one day. In emergency department, noted to be hypertensive to ~200/100 with H... Read more
expressive aphasia for one day. In emergency department, noted to be hypertensive to ~200/100 with HR to 100s.
66 2021-04-20 hypertension, heart rate increased Experienced very high blood pressure/blood pressure was 190/119; The blood vessel broke in her left ... Read more
Experienced very high blood pressure/blood pressure was 190/119; The blood vessel broke in her left eye/ there was blood in half of her eyes; Very high heart rate/heart rate was 126/heart rate was 150 and she did not even feel it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Experienced very high blood pressure/blood pressure was 190/119), EYE HAEMORRHAGE (The blood vessel broke in her left eye/ there was blood in half of her eyes) and HEART RATE INCREASED (Very high heart rate/heart rate was 126/heart rate was 150 and she did not even feel it) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. Concurrent medical conditions included Crohn's disease and Colitis. Concomitant products included MESALAMINE for Crohn's disease and Colitis. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced HYPERTENSION (Experienced very high blood pressure/blood pressure was 190/119) (seriousness criterion hospitalization), EYE HAEMORRHAGE (The blood vessel broke in her left eye/ there was blood in half of her eyes) (seriousness criterion hospitalization) and HEART RATE INCREASED (Very high heart rate/heart rate was 126/heart rate was 150 and she did not even feel it) (seriousness criterion hospitalization). At the time of the report, HYPERTENSION (Experienced very high blood pressure/blood pressure was 190/119) had resolved and EYE HAEMORRHAGE (The blood vessel broke in her left eye/ there was blood in half of her eyes) and HEART RATE INCREASED (Very high heart rate/heart rate was 126/heart rate was 150 and she did not even feel it) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood pressure measurement: 141/90. On 16-Mar-2021, Blood pressure measurement: 136/84. On 17-Mar-2021, Blood pressure measurement: 140/91. On 22-Mar-2021, Blood pressure measurement: 155/94. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported to be treated with beta blockers and test were performed and came out "okay". No further information regarding test results or types of tests was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
66 2021-04-21 cerebrovascular accident Had a seizure/stroke beginning at 8 pm and was brought to the ER. Was admitted in ICU
66 2021-04-22 arrhythmia On about 3/24/21 , or about two weeks after my first vaccine dose, I began to have frequent episodes... Read more
On about 3/24/21 , or about two weeks after my first vaccine dose, I began to have frequent episodes of heart arrhythmia, sometimes every third day, sometimes every other day, at times two days in a row. I had bee diagnosed with SVT about ten years ago, but episodes were infrequent, about once every two months. Since the last week in March, they have been at the frequency described above and continue to the present. I have been referred by my primary care doctor to be seen again by my heart arrhythmia specialist. I have not seen him or had any tests since April 2019.
66 2021-04-22 chest discomfort, chest pain Pains and pressure in chest 4 days, G.I. issue 5 days, Headache most days, nausea 4 days, joint pain... Read more
Pains and pressure in chest 4 days, G.I. issue 5 days, Headache most days, nausea 4 days, joint pain 5 days, dizziness 2 days, loss of appetite 4 days, painful lump under vaccine arm 3 days, fatigue, loss of concentration 9 days. 15+ days with various symptoms
66 2021-04-22 pulmonary embolism, deep vein blood clot 3 days of dyspnea on exertion, dry cough and right thigh pain. CT chest with acute submassive pulmon... Read more
3 days of dyspnea on exertion, dry cough and right thigh pain. CT chest with acute submassive pulmonary emboli, saddle PE across main pulmonary arteria. Right lower extremity DVT. Echo - mild RV dilation and reduced RV systolic function.
66 2021-04-22 pulmonary embolism, fibrin d dimer increased Patient received Moderna vaccine and was in her usual state of health. Developed shortness of breath... Read more
Patient received Moderna vaccine and was in her usual state of health. Developed shortness of breath and dyspnea of exertion for 2 weeks. Presented to her Physician's office who ordered a CT Angio which revealed multiple acute pulmonary emboli throughout both left and right main pulmonary arteries and lobar branches with ventricular strain. Patient underwent EKOS procedure to remove clot burden and was initiated on Xarelto. Patient is requiring 4L of oxygen at this time.
66 2021-04-22 fainting Diaphoresis, abdominal cramping, loose stools, syncope x2 Lactic acidosis, descending colitis on CT ... Read more
Diaphoresis, abdominal cramping, loose stools, syncope x2 Lactic acidosis, descending colitis on CT felt to be ischemic colitis.
66 2021-04-22 fainting Vaso-Vagal syncope in the 1st dose; This spontaneous case was reported by a consumer and describes t... Read more
Vaso-Vagal syncope in the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Vaso-Vagal syncope in the 1st dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history was provided.). On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced SYNCOPE (Vaso-Vagal syncope in the 1st dose) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Vaso-Vagal syncope in the 1st dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information for the event was provided. Patient decided not to get 2nd shot due to syncope with first dose. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
66 2021-04-23 heart failure 66-year-old lady with severe COPD on home 2L O2 (initiated 3/21), newly diagnosed SCC of lung (not c... Read more
66-year-old lady with severe COPD on home 2L O2 (initiated 3/21), newly diagnosed SCC of lung (not currently on treatment), HFpEF, schizoaffective disorder, and recent COVID-19 infection (dx 4/6) who presented with shortness of breath on 4/16 in the setting of receiving first dose of Covid vaccine 1 week prior. Found to have sepsis physiology w/ hypoxic respiratory failure from COVID-19 pneumonia. CXR with multifocal pneumonia in the setting of chronic interstitial changes and required up to 6 L nasal cannula. Started on IV remdesivir (x 5 days ending 4/20) and Decadron x6 days, ending 4/21. Clinically improved and weaned to her baseline 2 L O2 and discharged on 4/21 to rehab
66 2021-04-23 fainting "Moderna COVID-19 Vaccine EUA" - Chills and nausea beginning at 4:30 am (12.5 hrs after vaccine); na... Read more
"Moderna COVID-19 Vaccine EUA" - Chills and nausea beginning at 4:30 am (12.5 hrs after vaccine); nausea dissipated about 7:30 am; chills remained until about 11:00 pm; also had dizziness for about 3 hours beginning at 8:00 am (fainted in the shower); felt tired and weak the entire day following the vaccine; only treatment was taking it easy & resting throughout the day
66 2021-04-26 chest pain first vaccine-started within 3 hrs of injection. Intense muscle and joint pain for 48 hours. second ... Read more
first vaccine-started within 3 hrs of injection. Intense muscle and joint pain for 48 hours. second vaccine-started within 30 minutes of injection=dizziness. Followed within 3 hours=shaking, intense pain in muscles and joints, intense headache, chills off and on. This continued for 72 hours. Followed by intense feeling of burning up interspersed with the chills. Culminating at 82 hours with intense chest pains. I then had to take 4 nitroglycerin pills, 0.4mg each ( 1 every 5 minutes) before the chest pains stopped. Then after that, all of the side effects ceased except for tiredness which lasted another 24 hours. Note: I have nitroglycerin on hand since I had a heart attack in 2001. I only occasionally need to take it, not more then 1x/year, sometimes I can go for several years without taking any. If I had not had any on hand, I would have gone to the nearest ER. Note-I have continued to have shakiness off and on about 3x/week which is still persisting.
66 2021-04-26 loss of consciousness, hypotension Blood pressure low; Rash on the stomach, chest, arms, thighs, toes, legs and face; Chills; Tremendou... Read more
Blood pressure low; Rash on the stomach, chest, arms, thighs, toes, legs and face; Chills; Tremendous headache; Fever of 100.5; Weakness; Collasped; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Collasped) and HYPOTENSION (Blood pressure low) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Collasped) (seriousness criterion medically significant) and ASTHENIA (Weakness). On 30-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (Tremendous headache) and PYREXIA (Fever of 100.5). On 01-Apr-2021, the patient experienced HYPOTENSION (Blood pressure low) (seriousness criterion hospitalization) and RASH (Rash on the stomach, chest, arms, thighs, toes, legs and face). On 29-Mar-2021, LOSS OF CONSCIOUSNESS (Collasped) had resolved. At the time of the report, HYPOTENSION (Blood pressure low), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Tremendous headache) and PYREXIA (Fever of 100.5) outcome was unknown and RASH (Rash on the stomach, chest, arms, thighs, toes, legs and face) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Pyrexia: 100.5 Patient experienced fever of 100.5.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment included diphenhydramine and acetaminophen. On 01 Apr 2021, the patient experienced a fever of 100.5 degree Fahrenheit and noted a rash to the stomach. The patient then called 911. The paramedics checked the patient out and noted patient's blood pressure to be low and was taken to the hospital. On unknown date, the patient was discharged home after receiving some unspecified medications. On 02 Apr 2021, the patient reported the rash was full blown, was on the stomach, chest, arms, thighs, toes, legs and face. The rash subsided on unknown date. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
66 2021-04-26 palpitations Patient has hx of cardiac issues "kissing lesions" - when stressed/excited - takes 1/2 toprol and s/... Read more
Patient has hx of cardiac issues "kissing lesions" - when stressed/excited - takes 1/2 toprol and s/s resolve. She did this for her heart palpitations r/t vaccine dose #2 and this s/s resolved. 1/30/21 530pm- fever of 100F, was 102, took 2 tylenol - 99F after that. 1/31/21 10am - fever, itching all over 9scalp, toes, every where). Patient declined COVID testing at this time. Patient advised to call back with s/s update, patient verbalized understanding.
66 2021-04-26 platelet count decreased Her platelets went from 94 to 92; blood work showed low platelet and CD4 cell counts; This spontaneo... Read more
Her platelets went from 94 to 92; blood work showed low platelet and CD4 cell counts; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (Her platelets went from 94 to 92) and CD4 LYMPHOCYTES DECREASED (blood work showed low platelet and CD4 cell counts) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 028L20A) for COVID-19 vaccination. The patient's past medical history included Pacemaker insertion (cardiac) since an unknown date. Concurrent medical conditions included HIV positive, Diabetes and Bleeding (Her bleeding risk was so high at the moment that she had to cancel her pain shot.). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PLATELET COUNT DECREASED (Her platelets went from 94 to 92) and CD4 LYMPHOCYTES DECREASED (blood work showed low platelet and CD4 cell counts) (seriousness criterion medically significant). At the time of the report, PLATELET COUNT DECREASED (Her platelets went from 94 to 92) and CD4 LYMPHOCYTES DECREASED (blood work showed low platelet and CD4 cell counts) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood test: abnormal (abnormal) abnormal. On 13-Apr-2021, Platelet count decreased: 92 (Low) Low. No treatment information provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, this patient's concurrent medical conditions including viral infection (HIV) and diabetes may remain as confounders. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, this patient's concurrent medical conditions including viral infection (HIV) and diabetes may remain as confounders. Further information has been requested.
66 2021-04-27 blood glucose increased The day after her first dose of COVID, patient woke up confused and disoriented. Did not know who h... Read more
The day after her first dose of COVID, patient woke up confused and disoriented. Did not know who her husband was. Was taken to the ER. Confusion last about 1 hour. Patient also had pain at vaccine administration site, temp of 101 and BS of 300+ which is high for her.
66 2021-04-27 deep vein blood clot deep venous thrombosis on 4/21/21
66 2021-04-27 hypertension Headache, Nausea, Vomiting starting 4-9-2021, until 4-14-2021 when I went to ER. Found to be Hyperte... Read more
Headache, Nausea, Vomiting starting 4-9-2021, until 4-14-2021 when I went to ER. Found to be Hypertensive, 190/ 90, and Hyponatremic, Critical Lab Value 120. Sent via ambulance on 4-14-2021 to. Placed on step-down MICU until 4-16-2021. Sent home on Sodium Tablets 2/day, and Amlodipine Besylate 10mg/day
66 2021-04-27 loss of consciousness Systems lasting 4 days: fever, unable to stay awake, kept on passing out, dizziness and light headed... Read more
Systems lasting 4 days: fever, unable to stay awake, kept on passing out, dizziness and light headed, fell, unable to eat only able to drink water. Systems lasting 13 days:Extreme body and head pain, extreme dizziness and light headed, fell.
66 2021-04-28 chest pain, chest discomfort, hypertension Blood clots in both lungs upper and lower chambers New stage 2 HBP Chest pain and tightness Shortnes... Read more
Blood clots in both lungs upper and lower chambers New stage 2 HBP Chest pain and tightness Shortness of breath Fever, headache, joint pain severe, chills, nausea
66 2021-04-28 deep vein blood clot DVT
66 2021-04-28 sinus rhythm, chest pain Patient for 2nd Moderna vaccine. Immediately after vaccine patient c/o chest pain. 1203 b/p 211/108.... Read more
Patient for 2nd Moderna vaccine. Immediately after vaccine patient c/o chest pain. 1203 b/p 211/108. EKG done NSR. Clonidine given at 1205. Nitro given @1230. Tylenol given at 1247 for headache. PCP in room. patient reports jaw, neck and arm pain, diaphoresis and midsternal chest pain. EMS called . Patient sent to hospital for further evaluation. Hospitalist and IPCM notified. Vitals Vital Signs Recorded: 29Apr2021 01:15PM Systolic: 159 Diastolic: 82 O2 Saturation: 96 FiO2: 2L/min Recorded: 29Apr2021 12:59PM Systolic: 131 Diastolic: 73 O2 Saturation: 92 FiO2: 2L/min Recorded: 29Apr2021 12:47PM Systolic: 162 Diastolic: 81 O2 Saturation: 82 Recorded: 29Apr2021 12:36PM Heart Rate: 94 Systolic: 211 Diastolic: 101 Recorded: 29Apr2021 12:20PM Systolic: 184 Diastolic: 70 O2 Saturation: 94 Recorded: 29Apr2021 12:05PM Heart Rate: 105 Respiration: 24 Systolic: 210 Diastolic: 108 O2 Saturation: 97
66 2021-04-28 blood clot acute superficial thrombus
66 2021-04-28 blood clot Entered hospital on 3/22/21 At around 8am in the emergency room. Had ultrasound of left leg and was ... Read more
Entered hospital on 3/22/21 At around 8am in the emergency room. Had ultrasound of left leg and was placed in ICU for a massive blood clot in the left leg. Had surgery at around 4pm on 3/22/21 and placed back in ICU until the next surgery on 3/23/21 to remove the blood clot. Was released on 3/25/21.
66 2021-04-29 heart failure That night chills, fever 102, diarhrea, Shortness of breath. Shortness of breath continued to get wo... Read more
That night chills, fever 102, diarhrea, Shortness of breath. Shortness of breath continued to get worse, 3rd day went to ER. Stated I was in heart failure. Took multiple doses of lasix, BNP was over 2200, followed up with family Dr. contacted Cardiologist, he had echo and lab work done, BNP down to 1200. I did not have the shortness of breath until after vaccine. Still am having. See primary Dr Monday and follow-up with Cardiologist the 28th.
66 2021-04-29 blood clot Had three blood clots within 36 hours. One in left leg, one right leg and one in groin. Also, rheum... Read more
Had three blood clots within 36 hours. One in left leg, one right leg and one in groin. Also, rheumatological problems in tendons in arms and legs.Hearing in left ear diminished by 10%.
66 2021-04-30 loss of consciousness Blacked out and passed out completely; Next morning, around 6:30am, I woke up feeling dizzy; Morning... Read more
Blacked out and passed out completely; Next morning, around 6:30am, I woke up feeling dizzy; Morning after second dose, my temperature was 99.3degF; Breast pain on my left side which has been there for a while after the second shot; Felt so dehydrated after the second shot; My head felt a little muddled; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out and passed out completely) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (My head felt a little muddled), BREAST PAIN (Breast pain on my left side which has been there for a while after the second shot) and DEHYDRATION (Felt so dehydrated after the second shot). On 10-Apr-2021, the patient experienced PYREXIA (Morning after second dose, my temperature was 99.3degF). On 10-Apr-2021 at 6:30 AM, the patient experienced DIZZINESS (Next morning, around 6:30am, I woke up feeling dizzy). On 10-Apr-2021 at 9:45 AM, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out and passed out completely) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out and passed out completely) had resolved, FEELING ABNORMAL (My head felt a little muddled), BREAST PAIN (Breast pain on my left side which has been there for a while after the second shot) and DEHYDRATION (Felt so dehydrated after the second shot) had not resolved and DIZZINESS (Next morning, around 6:30am, I woke up feeling dizzy) and PYREXIA (Morning after second dose, my temperature was 99.3degF) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Physical examination: normal. On 10-Apr-2021, the patient blacked out and passed out completely. She gained consciousness as her family members were carrying her. Her regular body temperature is 97.6degF. The patient felt so dehydrated after the second shot that her son had to keep on giving her water every 15 minutes. The patient took Tylenol for the symptoms. The patient also had physical examination with her gynecologist before first shot and it was normal. This case was linked to MOD-2021-089609 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
66 2021-04-30 palpitations My BP has all of a sudden changed from perfect to. 138/83 at my recent pain management doc Appt last... Read more
My BP has all of a sudden changed from perfect to. 138/83 at my recent pain management doc Appt last week-that is alarmingly high for me. Both legs have begun tingling from toes to butt; and tingling initially seemed to increase in the evening although now they just tingle extreme day and night non-stop. My legs throb to the beat of my heart. My heart pounds hard in my chest. I feel the need to always take long deep full belly breaths I order to get the oxygen I feel I need. I feel like I?m shaking inside. Feel very fidgety where I?m moving my tongue around inside my mouth, grinding my teeth although I try not to, jaw hurts from clenching, my legs/feet won?t stop moving/rubbing one a other yet I try to control it.. NOTE: I do nor think, feel this is related to Anxiety and I?ve stated this. These symptoms are extreme, there are multiple symptoms and there onset hit me in a debilitating way; and yet they were all dismissed. To muddy to waters more?I feel the deepest strangest oddest exhaustion I?ve ever experienced in my life ?it?s not tired-it?s quite different than tired-it?s painful, I?m barely able to take care of myself.. My days since Mid-January are increasingly getting more and more debilitatingly strange, exhausting, painful (migraines increasing in frequency and I?m having pain level ?10? spanning multiple days and most recently muscle aches that inhibit my walk), decreasing appetite, increasingly nauseated, struggling to stay hydrated. Quick example of right now- my leg was resting on top of the other at my ankle while I sitting here in couch w/legs up. First it takes effort to just sit here...it takes energy and it hurts...and out of nowhere my leg thats slightly resting normally underneath my top leg at the ankle begins to shoot a burning pain from the bottom ankle up to my knee. And I become aware that?I must grab another deep breath in order to get that top leg off quickly to stop the pain. I noticed in the past year my hair has begun thinning quite a bit. However in the past few months there?s been a big change. Excessive falling our, Mu extremities-legs & hands feel extremely cold and are cold to the touch. Many evenings I must soak both feet in the hotter water possible to combat the awful feeling of cold outside and inside my feet. I?ve had some anxiety attacks and I?m depressed about this. My migraines have begun raging 5-6 days per week often running from one day into the next, not breaking. I?m not able to sleep due to pain in upper back (especially left side) & neck-it?s flaring up kicking off the migraines. I can feel my occipitals, they hurt to the touch. My hair hurts. I wake up between 3-5am from the upper back/neck pain-The pain feels then goes up - feels like 2 rods going up the back of my neck and on top of my head. First the pain grips me behind my eyes. Often I cannot reach my abort pill (Imitrex) which I always have within arms reach on the nightstand with water-The pain is usually too much. The pain eventually moves from behind my eyes up to my eyebrow-forehead area. The pain can extend on top of my head but not as frequently. When I take the Imitrex pill I usually feel some relief (pain level 3-4) within an hour. Seldom does the pain ever fully leave - Handful of times a year; that so difficult to write:( I was told to get my second COVID shot Did sono of legs
66 2021-05-03 cardiac failure congestive Increased weakness, shortness of breath, falls, dyspnea and orthopnea, acute kidney injury, bilatera... Read more
Increased weakness, shortness of breath, falls, dyspnea and orthopnea, acute kidney injury, bilateral lower extremity swelling, nausea, abdomen pain. Treated at ER 3/10/2021 - discharged home so patient could recieve dose 2 on 3/11/2021. Admitted 3/20/2021 for worsening of all symptoms and Cardiac cathe performed. Discharged to rehab facility 3/30/2021
66 2021-05-03 brain sinus blood clot Patient is a 66-year-old female with a history of diabetes hyperlipidemia hypertension low back pain... Read more
Patient is a 66-year-old female with a history of diabetes hyperlipidemia hypertension low back pain who presents from vaccine clinic complaining of numbness and tingling in her left lower extremities. Patient also states she has been having nausea and mild headache. she notes that she took her blood pressure medicines this morning as per her usual. She denies any chest pain palpitations domino pain or diarrhea. Patient states she thinks she may have history of sciatica note that this pain feels different from her normal numbness and tingling in the lower extremity.
66 2021-05-04 heart attack, cardiac arrest Covid19 vaccine: The patient received her second dosage of Moderna on 3/23.Patient called family med... Read more
Covid19 vaccine: The patient received her second dosage of Moderna on 3/23.Patient called family medicine triage on 4/1 regarding arm/shoulder pain from her vaccine site that was not improving. Pain started out near injection site but last couple days has been spreading to shoulder, some possible swelling, per patient. Finding it hard to sleep. Denies redness, warmth. Feels warm but no chills, doesn't have thermometer at home. The patient refused to call the COVID hotline. She was calling for an in-person appointment and was triaged for her symptoms. The next in-person appointment was not until Saturday 4/3, and it was given to the patient. She did not want to go to the ED. She suffered a witnessed massive heart attack the same day in her home and her partner called 911. Per parnter's report, walked around a little that day, in discomfort. Then came home and laid down with more arm pain. She had acute L arm pain and then agonal breathing - passed in order of 2-3 minutes. Likely cardiac arrest after MI for few days. She was BIBA the EMTs continued CPR for ~20 minutes but was unable to revive patient. She was pronounced dead on 2023.
66 2021-05-05 blood pressure fluctuation blood pressure kept going up and down\she could not get her blood pressure under control; Fever at i... Read more
blood pressure kept going up and down\she could not get her blood pressure under control; Fever at injection site (right arm); muscle aches in neck; Sharp pains in legs; pain in stomach; had blurred vision; she had floaters; headache; she had a fever where the vaccine was given (at injection site); body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE FLUCTUATION (blood pressure kept going up and down\she could not get her blood pressure under control) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 044A01A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Eye operation in March 2021. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (blood pressure kept going up and down\she could not get her blood pressure under control) (seriousness criterion hospitalization), VACCINATION SITE WARMTH (Fever at injection site (right arm)), NECK PAIN (muscle aches in neck), PAIN IN EXTREMITY (Sharp pains in legs), ABDOMINAL PAIN UPPER (pain in stomach), VISION BLURRED (had blurred vision), VITREOUS FLOATERS (she had floaters), HEADACHE (headache), VACCINATION SITE PAIN (she had a fever where the vaccine was given (at injection site)) and MYALGIA (body aches). The patient was hospitalized from 06-Apr-2021 to 10-Apr-2021 due to BLOOD PRESSURE FLUCTUATION. At the time of the report, BLOOD PRESSURE FLUCTUATION (blood pressure kept going up and down\she could not get her blood pressure under control) had not resolved and VACCINATION SITE WARMTH (Fever at injection site (right arm)), NECK PAIN (muscle aches in neck), PAIN IN EXTREMITY (Sharp pains in legs), ABDOMINAL PAIN UPPER (pain in stomach), VISION BLURRED (had blurred vision), VITREOUS FLOATERS (she had floaters), HEADACHE (headache), VACCINATION SITE PAIN (she had a fever where the vaccine was given (at injection site)) and MYALGIA (body aches) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment for the event included blood pressure medication and eye drops. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
66 2021-05-05 hypotension, low blood oxigenation, oxygen saturation decreased Summary:66-yof with past medical history of ESRD HDD Monday Wednesday Friday, COPD not on home oxyge... Read more
Summary:66-yof with past medical history of ESRD HDD Monday Wednesday Friday, COPD not on home oxygen, hypertension, depression, hyperlipidemia, who comes to the ED with 4 weeks duration of generalized malaise, fatigue, and loose stool. Incidentally she reports her daughter tested positive for Covid on Sunday and she was exposed at that time, but sx pres for several wks . She was noted have a fever of 102.3. Ferritin 1086. Her O2 sats declined to 92 percent the emergency room. She also tested positive for Covid 19.
66 2021-05-06 cerebrovascular accident On Saturday, April the 3rd, my wife's left leg became numb, and she had a tingling feeling. I took ... Read more
On Saturday, April the 3rd, my wife's left leg became numb, and she had a tingling feeling. I took her immediately to ER, where they perform CT and MRI. She was internally transferred to the hospital, where she stayed there until April the 14th, when she was transferred to (the Rehabilitation Institute) to begin physical and occupational therapy. As of today, mi wife doesn't have proprioception in neither of her legs nor her belly (she has no control on bowel and bladder).
66 2021-05-06 oxygen saturation decreased, pallor, skin turning blue In the hours following the first dose on 3/19/2021, sustained fever between 100 - 102 degrees, heada... Read more
In the hours following the first dose on 3/19/2021, sustained fever between 100 - 102 degrees, headaches, chills, clammy. The symptoms continued all day on the 3/20/2021. Sometime after 5:30 am on the 3/21/2021 she could not breathe. Pulse oximeter registered 57. contacted ambulance, within their arrival 10-15 minutes later, pulse oximeter was down to 43. Lips were blue skin was pale and clammy. At hospital she received high doses of oxygen and was treated for other symptoms.
66 2021-05-08 heart rate increased, blood pressure increased 102.3 fever, elevated heart rate & blood pressure. Fever did not go down with aspirin and tylenol f... Read more
102.3 fever, elevated heart rate & blood pressure. Fever did not go down with aspirin and tylenol for 1 day. Shot location swollen, red and hot - about size of tennis ball. Super lethargic, tired had to sleep, chills, & sweats. Body smelled of ammonia (not of urine). Symptoms lasted for 1.5 days, but arm is still hot, red and swollen.
66 2021-05-09 blood glucose increased My blood sugar has spiked mid to high 200s. My A1C was 10. Previous to the vaccination, my numbers w... Read more
My blood sugar has spiked mid to high 200s. My A1C was 10. Previous to the vaccination, my numbers were in the low 100s and my A1C was 7.2. I'm getting blood tests for insulin levels and C-reactive peptides this week. The only difference is the vaccine.
66 2021-05-09 cerebrovascular accident Stroke; Encephalitis; This spontaneous case was reported by a consumer (subsequently medically confi... Read more
Stroke; Encephalitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and ENCEPHALITIS (Encephalitis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Blood disorder NOS (blood clotting disorder from 20 years). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant) and ENCEPHALITIS (Encephalitis) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and ENCEPHALITIS (Encephalitis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported that magnetic resonance imaging (MRI scan) performed months back detected encephalitis, stroke and stated as totally asymptomatic. The patient reported to be taking Clopidogrel (Plavix) to treat the event. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. This case was linked to MOD-2021-101992 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
66 2021-05-10 palpitations Twelve hours after I received the vaccine began to feel warm and flushed. My temporal digital therm... Read more
Twelve hours after I received the vaccine began to feel warm and flushed. My temporal digital thermometer registered 97.6. I then began to feel chills and body aches. With about 30 minutes I developed a bad headache and tried to rest. I took two Advil and had no relief. My heart felt like it was racing, however, I was not short of breath. I continued to self monitor and see if the Advil might help the headache. The headache and palpitations continued for the next 8 hours. I was extremely frightened. I came very close to calling 911. I continue to feel lightheaded, headaches and fatigue as of today 5/11/2021
66 2021-05-13 hypertension 02/26/21 presented to EC with "hypertension and constipation"; from an care facility. 02/26/21 lab... Read more
02/26/21 presented to EC with "hypertension and constipation"; from an care facility. 02/26/21 lab SARS-CoV-2 (COVID-19) detected.
66 2021-05-13 hypotension, low blood oxigenation, haemoglobin decreased, blood pressure decreased, fluid around the heart "Moderna COVID-19 Vaccine EUA" -- patient hospitalized with covid19 after receiving one dose moderna... Read more
"Moderna COVID-19 Vaccine EUA" -- patient hospitalized with covid19 after receiving one dose moderna vaccine. 66 y.o. female with hypertension and diabetes admitted with sharp abd pain, nausea, vomiting for several days. CT abd with cecal distention, findings concerning for cecal volvulus. Extended resp panel positive for SARS-CoV-2 (received 1st dose of COVID vaccine on 3/22). Went to OR for exploratory laparotomy, lysis of adhesion and right colectomy. Patient was also found to be Covid-19 positive and needed supplemental oxygen in ED (3L NC at the time). Imaging showing bilateral pulmonary infiltrates/effusions (and also cecal volvulus, as stated above, pt underwent exloratory laparotomy, lysis of adhesion, right colectomy with ilecolostomy). Patient was recovering on medical floor when she clinically decompensated and needed increased oxygen and had a drop in blood pressure (confused, hypotensive, hypoxic). Labs notable for BUN 37, creatinine 2.16, procalcitonin 17.62, Hgb 6.4 (10 on admission). ABG 7.35/ 28/ 73/ 16/ 94% on nasal cannula. 1 unit PRBC given. BP continued to be borderline and was placed on vasopressor briefly. Empiric antibiotics vancomycin/cefepime/Flagyl, and patient was also started on remdesivir and dexamethasone. Nadir O2 sat was 82% on 3/31/2021. T=102.2 on 3/31/21. Patients had multiple family members with Covid-19. Treatments as stated above included Remdesivir and Dexamethasone. Cultures negative - exact source of sepsis unclear: bacterial pneumonia vs. covid vs. intra-abdominal source In ICU from 3/31 to 4/3. Medical floor 4/3 to 4/7. Patient was discharged home 4/7/21.
66 2021-05-16 pulmonary embolism Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID inje... Read more
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID injection. Diagnosis was acute pulmonary embolism.
66 2021-05-23 atrial fibrillation Patient began experiencing some shortness of breath 15 minutes after the injection with audible whee... Read more
Patient began experiencing some shortness of breath 15 minutes after the injection with audible wheezing. This nurse assessed her and found the following: LS tight/rhonci whole L side w/wheezing in bilat upper lungs, O2 sat 96% on RA, skin pink/warm, no change in color, no diaphoresis noted, HR regular/98. Patient was able to converse. 911 was activated, paramedics heard air movement throughout lungs, still 96% on RA, BP 141/92. Taken by ambulance to ED due to long history of asthma and no recue inhaler on her person.
66 2021-05-23 body temperature decreased, haemoglobin decreased 1/24/21 I received the Moderna 1st vaccine through the county fairgrounds. 2/11/21 I started experi... Read more
1/24/21 I received the Moderna 1st vaccine through the county fairgrounds. 2/11/21 I started experiencing terrible mouth pain on the right side. This included pain in the bone, teeth, gums, cheek and right ear. Thinking it might be a bad tooth I went to the dentist the next day 2/12/21 Dr. took x-rays of the upper and lower right side and found no tooth problem 2/15 After taking continuing pain meds the pain in the right side of my mouth went away, but feeling fatigued. 3/2/21 I received the Moderna 2nd vaccine at the county fairgrounds. I was sick for 3 days with a low temperature. 3/10/21 I had my teeth cleaned and xrays at Dr. office Dental practice. He said everything looked good including fillings. 3/25/21 I started experiencing terrible mouth pain on the left side of my mouth. This included pain in the bone teeth, gums, cheek, right ear and right side of my throat. 3/26/21 I went to the Urgent care. Doctor could find nothing wrong. The Dr. prescribed 3 days of steroids. After 3 days of steroids and other pain meds the pain went away. 3/30/21 I was now experiencing tooth pain specific to the upper right back molar and the upper left back molar. They both felt loose ad pain when chewing. 4/7/21 I went to my dentist and he said the upper right molar appeared to be cracked and needed to be extracted. The upper left molar looked like it could be capped but then he found out later it was also cracked and had to be removed. 4/13/21 I was experiencing headache, fatigue, and shortness of breath when exerting myself. Talked to the triage nurse and made an appointment for 4/19/21 4/14/21 Upper right back molar cracked and was extracted by my Dr at the dentist. 4/19/21 Upper left back molar cracked and was extracted by my Dr at the dentist. 4/19/21 I saw a Dr at urgent care for fatigue, shortness of breath and headache. She did a checkup and blood work. 4/20/21 I was rushed to the emergency room for critically low hemoglobin (5.5) and given 2 units of blood, fluids, and a B12 infusion. 4/21/21 Endoscope procedure while in the hospital showed a possible hernia problem but there was no strong conclusive reason for my mouth pain, cracked teeth and low hemoglobin. I am now taking supplements and seemed much recovered. I believe this was a onetime event caused by the vaccine. My primary doctor, agrees the mouth pain has been reported as a side effect. In October of 2020 I had a complete checkup with my primary Dr. and was found to be very healthy and did not have any problems until I received the vaccine. I would like to know if there is a pool of money I could draw from as I now need two implants to replace the two cracked teeth.
66 2021-05-23 inflammation of the pericardium, chest pain, increased heart rate acute pericarditis, chest pain and fatigue
66 2021-05-23 pulmonary embolism, chest pain 2 DAYS POST SECOND MODERNA VACCINATION (4/30) PTNT BEGAN EXPERIENCING SHORTNESS OF BREATH AND CHEST ... Read more
2 DAYS POST SECOND MODERNA VACCINATION (4/30) PTNT BEGAN EXPERIENCING SHORTNESS OF BREATH AND CHEST PAIN. 6 DAYS POST SECOND SHOT (5/4) PTNT WENT TO PRIMARY DOCTOR WHO DID BLOOD WORK. PATIENT WAS ADMITTED TO HOSPITAL ON MAY 19TH FOR CONFIRMED PULMONARY EMBOLISM TREATMENT. PATIENT DISCHARGED FROM HOSPITAL ON MAY 20TH ON 6 MONTH COURSE OF XARELTO.
66 2021-05-25 platelet count decreased Had COVID the month of December- no hospitalization. Had first moderna April 3, 2021. Second modern... Read more
Had COVID the month of December- no hospitalization. Had first moderna April 3, 2021. Second moderna shot May 4. I have had low platelets for a few years but not any lower than 43,000. Went for blood work on May 3 2021 for Dr. for check up and my platelets were 17,000. She prescribed me a steroid and brought them back up to 156,000 by May 10. She told me it was from COVID . My vaccine was very close to my appointment.
66 2021-05-26 loss of consciousness passed out; very bad infection from the Diverticulitis in the bowel; This spontaneous case was repor... Read more
passed out; very bad infection from the Diverticulitis in the bowel; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and DIVERTICULITIS (very bad infection from the Diverticulitis in the bowel) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history reported by the reporter. Concomitant products included LISINOPRIL for Blood pressure, POTASSIUM and OMEPRAZOLE for an unknown indication. On 04-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant) and DIVERTICULITIS (very bad infection from the Diverticulitis in the bowel) (seriousness criterion medically significant). On 04-May-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved. At the time of the report, DIVERTICULITIS (very bad infection from the Diverticulitis in the bowel) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Blood potassium: Low. On 04-May-2021, Blood pressure measurement: Low. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Events included some other issues. Patient was treated with 2 unspecified antibiotics. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
66 2021-05-26 palpitations, pulse abnormal Palpitations severe enough to cause dizzy and lightheaded upon getting out of bed. After three days ... Read more
Palpitations severe enough to cause dizzy and lightheaded upon getting out of bed. After three days of erratic pulse went to dr who sent to ER, who sent to heart dr. 24 hour monitor and echo test showed palpitations. Prescribed beta blocker. Slow heart rate is causing problem too. No heart issues, rather electrical.
66 2021-05-28 chest pain On the morning of 3/21/2021 I awoke to skin pain on my LEFT side (Bilateral mastectomy lymph glands ... Read more
On the morning of 3/21/2021 I awoke to skin pain on my LEFT side (Bilateral mastectomy lymph glands only on right) from midsternal through the left scapula. Any touch was painful, sheets clothing etc. It felt like Shingles but no rash was there. day 3-7 terrible spleen pain with pressure under my left ribs radiating to my back to the base of my scapula. On day 8 the shingles rash appeared on my RIGHT side and I was put on Valtrex. Because of the sternal and rib pain I thought perhaps I was constipated so I took several laxatives to no avail. The rib pain was crushing even to the touch. It finally slowly dissipated staring day 9
66 2021-05-29 cardiac arrhythmia, heart failure About 1 month after her second dose of Moderna Covid vaccine she started noticing some shortness of ... Read more
About 1 month after her second dose of Moderna Covid vaccine she started noticing some shortness of breath with activity. She thought it was related to her subglottic stenosis that she gets dilated often. A month after her symptoms started she was seen in clinic by ENT for the stenosis and was noted to have significant leg swelling and sent to ED where she was admitted for heart failure & significant PVC burden on telemetry (about 30%). She was diuresed & discharged with the plan to do a Holter monitor and decided if she was a candidate for ablation for PVCs.
66 2021-05-30 deep vein blood clot 2 days later, she had diffuse joint pains, legs felt tight, still able to walk. She got second dose ... Read more
2 days later, she had diffuse joint pains, legs felt tight, still able to walk. She got second dose on 3/16. A few days after that, diagnosed by bilateral lower extremity DVTs
66 2021-05-31 fainting Fainting spell; She couldn't remember her job or her boss's name, with whom she worked since 2009/sh... Read more
Fainting spell; She couldn't remember her job or her boss's name, with whom she worked since 2009/she can't remember as good; Her right arm got kind of sore; Chills; Vomiting; Nausea; Fever; Diarrhea; Dizziness; Weak; She lost 6 pounds in 3 days; Confusion; Off work X 6 days; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (Fainting spell) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy, Diabetes, Heart disease, unspecified and Asthma. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weak), WEIGHT DECREASED (She lost 6 pounds in 3 days), CONFUSIONAL STATE (Confusion), IMPAIRED WORK ABILITY (Off work X 6 days), PYREXIA (Fever), VOMITING (Vomiting) and NAUSEA (Nausea). On an unknown date, the patient experienced SYNCOPE (Fainting spell) (seriousness criterion medically significant), AMNESIA (She couldn't remember her job or her boss's name, with whom she worked since 2009/she can't remember as good), PAIN IN EXTREMITY (Her right arm got kind of sore) and CHILLS (Chills). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SYNCOPE (Fainting spell), AMNESIA (She couldn't remember her job or her boss's name, with whom she worked since 2009/she can't remember as good), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weak), WEIGHT DECREASED (She lost 6 pounds in 3 days), CONFUSIONAL STATE (Confusion), IMPAIRED WORK ABILITY (Off work X 6 days), PAIN IN EXTREMITY (Her right arm got kind of sore), PYREXIA (Fever), CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown. Concomitant medication use included medications for diabetes, heart disease and high blood pressure. Specific medications were not provided by the reporter. Treatment of the events included Zofran. On 11Feb2021, after receiving the first dose of vaccine but before the second, the patient "had a nuclear injection" before she went on a treadmill. The patient also stated that "she had radiation that may have affected her reaction to the vaccine." No further information was provided. Further clinical course is unknown at this time. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-155323 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up received on 20-May-2021included additional events were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
66 2021-06-01 stroke Patient presented to ED 5/31 with complaints of dizziness for past 2 days, after taking 1st shot of ... Read more
Patient presented to ED 5/31 with complaints of dizziness for past 2 days, after taking 1st shot of vaccine 5/26. Patient admitted to hospital services after CT head revealed recent right hippocampal infarct
66 2021-06-02 chest pain pt had/has severe fatigue, SOB, chest pain, headaches, feeling tired and weak. This has been going o... Read more
pt had/has severe fatigue, SOB, chest pain, headaches, feeling tired and weak. This has been going on for months and started after first COVID moderna vaccine
66 2021-06-02 chest pain 2/25 early AM severe left side chest pain. 4/1 rash on back Grover's Disease, 5/22 extreme ankle pai... Read more
2/25 early AM severe left side chest pain. 4/1 rash on back Grover's Disease, 5/22 extreme ankle pain swollen and red foot for 24 hours, 5/31 extreme lower back pain for 12 hours. Unusually Fatigued, sad, and lifeless.
66 2021-06-03 cerebrovascular accident, low platelet count Stroke determined by clinical assessment (CMS/HCC) Facial weakness Thrombocytopenia, unspecified
66 2021-06-06 deep vein blood clot Blood clots in lungs and dvt
66 2021-06-06 excessive bleeding 4/7/2021--Patients boyfriend called to report that patient has had adverse reaction to her 2nd dose ... Read more
4/7/2021--Patients boyfriend called to report that patient has had adverse reaction to her 2nd dose of Moderna vaccine given on 4/1/21. He reports that after the vaccine was given she bled a lot and is concerned if this has contributed to her adverse reaction. She has had headache, cloudy vision, dizziness, brain fog, muscle fatigue, body aches and chills. She is still experiencing most of these side effects even though it's been about 6 days since her shot. Some of this are listed as common side effects to the vaccine but the cloudy vision, dizziness and brain fog were concerning to me - I recommended that she follow up with provider, especially if side effects have not improved by end of the day. It sounds like she's already been to the urgent care about this but did not receive much help there.
66 2021-06-09 inflammation of the heart muscle, chest discomfort, chest pain, troponin increased Per pt : had midsternal chest pain for a few min the day of the first infection and then resolved . ... Read more
Per pt : had midsternal chest pain for a few min the day of the first infection and then resolved . SHe mentioned that the the vaccine center during the second shot got mid sernal chest pain x 2 for a few min each time after the second dose _ within 24 hr of the vaccine and self resolved. + arthralgia's and muscle aches throughout the time She presented on 5/15/2021 with complains of chest pain in the midsternal area and to bilateral sides, no radiation and felt like pressure. EKG pertinent for v2,v3 TWI new from before. Troponin from 0.02--3.5 L heart Cath 5/17: No CAD , Normal LVEF Ct chest PE protocol : neg MRI heart :5/18: acute focal myocarditis left mid inferolateral segment with focal myocardial edema and fibrosis LYME AB SCREEN (Outside Lab) Latest Units: index <0.90 Negative SARS CoV 2 AB IGG (Outside Lab) Negative SARS COV 2 AB (IGG) SPIKE, SEMI QN Latest Ref Range: <1.00 index >20.00 (H) Adenovirus PCR Not Detected Enterovirus PCR Not Detected Sars-Cov-2 (Covid 19) by PCR Negative CYTOMEGALOVIRUS ANTIBODY (IGG) (Outside Lab) Latest Units: U/mL >10.00 (H) CYTOMEGALOVIRUS ANTIBODY (IGM) (Outside Lab) Latest Units: AU/mL <30.00 EchoV T6 Ab <1:10 EchoV T7 Ab <1:10 EchoV T9 Ab <1:10 EchoV T11 Ab <1:10 EchoV T30 Ab <1:10 EBV VIRAL CAPSID AG (VCA) AB (IGM) (Outside Lab) <36.00 EBV VIRAL CAPSID AG (VCA) AB (IGG) (Outside Lab) 242.00 (H) EBV NUCLEAR AG (EBNA) AB (IGG) (Outside Lab) 252.00 (H) INTERPRETATION (Outside Lab) Unknown PAST INFECTION HERPESVIRUS 6 AB (IGG) (Outside Lab) 1:20 (H) HERPESVIRUS 6 AB (IGM) (Outside Lab) <1:20 INFLUENZA TYPE B ANTIBODY SERUM (Outside Lab) Latest Ref Range: <1:8 titer 1:8 (H) PARVOVIRUS B19 ANTIBODY (IGG) (Outside Lab) Unknown 0.2 INFLUENZA TYPE A ANTIBODY SERUM (Outside Lab) Latest Ref Range: <1:8 titer 1:32 (H) PARVOVIRUS B19 ANTIBODY (IGM) (Outside Lab) Unknown 0.1 HIV 1 And 2 Latest Ref Range: Non-Reactive Non-Reactive
66 2021-06-10 heart rate decreased decline in condition, complaints of shortness of breath, recent unwitnessed falls, edema to bilatera... Read more
decline in condition, complaints of shortness of breath, recent unwitnessed falls, edema to bilateral lower extremities, incontinence of urine, tearfulness, low heart rate Pedal edema
66 2021-06-11 fainting Patient fainted a couple hours after vaccine. Last remembers calling work to say she couldn't come i... Read more
Patient fainted a couple hours after vaccine. Last remembers calling work to say she couldn't come in, then woke up 2 hours later on the couch (same place she made the call). Felt woozy before fainting.
66 2021-06-13 fainting So I mean it was a while after but anyway, I got up in the morning on March 22 2021 and I just faint... Read more
So I mean it was a while after but anyway, I got up in the morning on March 22 2021 and I just fainted. A few hours later I got nauseas and I felt like the room was spinning. I kept throwing up and I went to the ER. I stayed at ER and they diagnosed me with BPPV (basically vertigo). I followed up with PCD and cardiologist and i went to physical therapy. I am also scheduled to see an endocrinologist. At the ER i was on necklozine and anti nausea meds.
66 2021-06-14 heart rate increased, heart attack, palpitations heart attack; Heart palpitations elevated; Heart rate went high; This spontaneous case was reported ... Read more
heart attack; Heart palpitations elevated; Heart rate went high; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack), PALPITATIONS (Heart palpitations elevated) and HEART RATE INCREASED (Heart rate went high) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Heart palpitations elevated) (seriousness criterion hospitalization) and HEART RATE INCREASED (Heart rate went high) (seriousness criterion hospitalization). At the time of the report, MYOCARDIAL INFARCTION (heart attack), PALPITATIONS (Heart palpitations elevated) and HEART RATE INCREASED (Heart rate went high) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High. Other concomitant product include high blood pressure medication. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was Not Applicable Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
66 2021-06-15 hypertension, arrhythmia Cardiac Arrhythmia and high blood pressure, now under the care of Cardiologist
66 2021-06-17 inflammation of the pericardium, chest pain Began having chest pain with breathing. Substernal pain that radiated into shoulders ipsilaterally.... Read more
Began having chest pain with breathing. Substernal pain that radiated into shoulders ipsilaterally. Increasing each day, sob started and became increasingly worse.On March 1, 2021 admitted to the Hospital, with Pericarditis and left lower lobe infiltrate. O2 sats 82.
66 2021-06-18 loss of consciousness passed out in public and hit head; Cough; This spontaneous case was reported by a nurse and describe... Read more
passed out in public and hit head; Cough; This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out in public and hit head) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No reported medical history. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out in public and hit head) (seriousness criterion medically significant) and COUGH (Cough). At the time of the report, LOSS OF CONSCIOUSNESS (passed out in public and hit head) and COUGH (Cough) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
66 2021-06-20 chest discomfort Dizziness not mild, like water running through my brain, within first 30 minutes and that went away ... Read more
Dizziness not mild, like water running through my brain, within first 30 minutes and that went away in a few minutes. But I still feel unsettled. Following four days, firstly, I started to feel like a punch headache, it's irregular and not constant. Like someone punched my head, like three punches in the head and then it go away and then the headache goes away. Then I had a mild temple headache., it's not always there. On the 6th day, on May 18th, I started to feel (before I went to bed about 10:00PM) all of a sudden I started to sweat and my whole face turned red. It was like heat just went over my head. I was brushing my teeth and I got scared. It went away within about 10-15 seconds. I started to feel something is wrong, so I went to measure my blood pressure. Knowing that when someone had a stroke, you have sweat etc. My blood pressure was 98/48. The following morning, I woke up and measured my blood pressure again, started to feel blurry vision. I had to make an effort when I talk, like there was no power in my chest. I started to feel pressure on my heart. When I talk, there is no energy from my chest (from lung or heart). It's either my heart or my lung whenever I try to talk, I have to make an effort. Whenever I think, I have to make an effort to think. I use to be fairly quick, responses are usually very quick. With this, everything slows down. My blurry vision and my brain (I don't remember how to write) makes it difficult to come up with a person's name. Like dementia or something. I noticed when I measure my blood pressure, that for the following two weeks my dystonic has never exceeded 55 whether morning or evening. May 28 was lowest: My heartbeat was only 50; my BP was 76/37. (My BPM was about 50.) I went to see my doctor. My appt was on 8th of June. May 30th my BPM was able to go above 60. I exercise and I was able to exercise but I have a discomfort over my chest. When I bike (slow biking), I was still able to finish 10 miles of biking even though it was pretty hard. I started to do very mild walking since June 8th I started mild walking and not doing hard exercise. I still have temple headache and I still have to make efforts when I talk and June 19th when I talk for 10 minutes, I'm exhausted. If I have to use my brain when I talk, I was exhausted. I have cancelled my second shot of Moderna because of symptoms I have encountered. I almost feel like trembling when doing this report. I can feel it. I'm recovering but not back to my old self.
66 2021-06-20 chest pain Developed shortness of breath two weeks after second vaccine in March 2021. Diagnosed with pneumoni... Read more
Developed shortness of breath two weeks after second vaccine in March 2021. Diagnosed with pneumonia on 5/28/21. Severe chest and back pain. No cough, no fever. 100% healthy prior to vaccine. For 3 days after second vaccine developed swollen arm, high fever 103.5. Then 2 weeks later SOB.
66 2021-06-22 chest discomfort Extreme fatigue, shortness of breath, pressure in chest, muscle aches
66 2021-06-25 heart rate increased Rapid heart beat for about 4 hours. The next day had same for about 1 hour. Fine after that.
66 2021-06-27 fast heart rate Three days after the second dose of the vaccine I woke up and I could not see. My vision was blurry,... Read more
Three days after the second dose of the vaccine I woke up and I could not see. My vision was blurry, and I was seeing double. It lasted for two days all day and than it went away. I went to the ER and I was Tachycardic. I went to the Ophthalmologist and there was no evidence of damage. Two weeks after the vaccine I had symptoms of a Stomach Virus with vomiting and diarrhea.
66 2021-06-29 cerebrovascular accident CVA- 4 BLOCKAGES IN SEPARATE LOBES ON LEFT SIDE OF BRAIN, OCCURRED IN TEMPORAL, THALAMUS, OCCIPITAL ... Read more
CVA- 4 BLOCKAGES IN SEPARATE LOBES ON LEFT SIDE OF BRAIN, OCCURRED IN TEMPORAL, THALAMUS, OCCIPITAL LOBES HAS EXTREME WEAKNESS ON THE RIGHT SIDE OF BODY, UNABLE TO USE RIGHT ARM AT TIME OF SUBMISSION, CAN MOVE RIGHT LEG MINIMALLY, CAN STAND WITH ASSISTANCE, SEVERE APHASIA
66 2021-06-29 haemoglobin decreased, loss of consciousness, heart rate irregular Well as far as I know, nothing happened the day of or anything like that. Then like 30 days after th... Read more
Well as far as I know, nothing happened the day of or anything like that. Then like 30 days after the vaccine I was short of breath and then one time I passed out, the paramedics took me in and they said that my heart wasn't beating right. I also got to episodes in the ambulance and two more in the hospital. So they put a temporary pacemaker put in on May the 1st for three days, then they put the defib in and after that I haven't had any problems and checked out.
66 2021-06-29 blood clot blood clotting.; pain in right leg and knee; pain in right leg and knee; This spontaneous case was r... Read more
blood clotting.; pain in right leg and knee; pain in right leg and knee; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clotting.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included ADHD, Anxiety, Inflammatory arthritis and Blood pressure high. Concomitant products included ATOMOXETINE HYDROCHLORIDE (STRATTERA) for Anxiety, SULFASALAZINE for Arthritis, PROPRANOLOL HYDROCHLORIDE (INDERAL) for Blood pressure high, PREDNISONE for Inflammatory arthritis. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced PAIN IN EXTREMITY (pain in right leg and knee) and ARTHRALGIA (pain in right leg and knee). On 11-Jun-2021, the patient experienced THROMBOSIS (blood clotting.) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clotting.), PAIN IN EXTREMITY (pain in right leg and knee) and ARTHRALGIA (pain in right leg and knee) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient visited ER due to pain the leg and knee and was diagnosed with blood clotting. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Added Reporter information(address, contact details), patient demographic information, medical history. Added vaccine batch number, route of administration, concomitant medication information. Start dates of the events pain in extremity and arthralgia added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
66 2021-07-01 fast heart rate Presented to the ED on 06/05/2021. Dx'd with Global Transient Amnesia
66 2021-07-02 coughing up blood, atrial fibrillation, cardiac arrest, ejection fraction decreased, low blood oxigenation, low platelet count Systemic Lupus Erythematosus, cardiac arrest for 6 minutes requiring CPR, global heart dysfunction,... Read more
Systemic Lupus Erythematosus, cardiac arrest for 6 minutes requiring CPR, global heart dysfunction, respiratory failure, received ECMO therapy Patient originally presented with new symptoms of diarrhea, rash, proximal weakness, and functional decline. Her outpatient workup included positive ANA and anti-SSA. She was then referred to Rheumatology for new diagnosis of Lupus. 6/11/2021 she was referred to the hospital for management of acute lupus flair. On admission she was found to have acute kidney injury and thrombocytopenia. AIR team was consulted given concern for active lupus, she was started prednisone as well as Plaquenil. On 6/17/2021, she brought emergently to MICU for lethargy, WOB, hypoxia, and new onset A-Fib. She was intubated and continued to clinically deteriorate with persistent lactic acidosis. An ECHO showed severely depressed EF and right heart dysfunction. On 6/17/2021 she experienced PEA arrest with 6 minutes of CPR. She was placed on VA ECMO with Impella. Patient was extubated on 6/19/2021 and was reintubated on 6/20/201 for hemoptysis. A CT on that day showed RP bleed on the left with extension into the left thigh and ground glass opacities throughout suggestive of ARDS. She tolerated a slow ECMO wean and was explanted successfully on 06/23. She was extubated on 06/25. Over the next several days she was able to be successfully weaned from HFNC and was transitioned to NC. On 6/28 she passed her swallow evaluation and was okayed for a PO diet. Plan is to transition patient to the floor in the next few days
66 2021-07-03 deep vein blood clot Swelling and pain in my left calf and ankle; the ER performed an ultrasound and determined that I h... Read more
Swelling and pain in my left calf and ankle; the ER performed an ultrasound and determined that I have an extensive deep vein thrombus.
66 2021-07-05 palpitations, hypertension Vaccination administered, and patient was observed after 30 minutes. At 1434, pt feeling that her "h... Read more
Vaccination administered, and patient was observed after 30 minutes. At 1434, pt feeling that her "heart is racing"; vs done; bp 165/82 with HR of 101; sats 99%; pt states the bp is a little high for her but not unusual given the situation. Pt states she feels ok to go home
66 2021-07-06 blood pressure increased I felt okay, until that night when I was trying to sleep I was sweating so bad I took BP it was 198/... Read more
I felt okay, until that night when I was trying to sleep I was sweating so bad I took BP it was 198/100 and the next morning it was same, I called advice nurse she said to go to ER if it goes over 105 when I checked it again it was 107 so I went to the ER.
66 2021-07-06 chest pain I can't say that I had an adverse reaction to the Covid10 shot. Only that I was sick from the end of... Read more
I can't say that I had an adverse reaction to the Covid10 shot. Only that I was sick from the end of May 2021 thru June 2021 with some sort of respiratory illness that took about a month to get better. I took antibiotics and ended up in the ER as my doctor advised me to get check out to make sure I didn't have a blood clot in my lungs.
66 2021-07-07 blood clot pain in leg , red, swollen
66 2021-07-08 atrial fibrillation Atrial Fibrillation
66 2021-07-09 oxygen saturation decreased Late January before the vaccine - I noticed that I was coughing and throwing up. The lung disease gi... Read more
Late January before the vaccine - I noticed that I was coughing and throwing up. The lung disease giving me a chronic cough. I was coughing but I was throwing up. That continued on for a non- frequent amount for about three months. And then it started to become more and more frequent until I couldn't eat anymore. It was getting more frequent - coughing and vomiting before - by the middle to end of May. I went to Hospital ER on June 2nd. They noticed that my oxygen saturation was very low and they were more concerned with that than what turned out to be the hernia (hiatal). They addressed the breathing. I am on oxygen 24/7 now - my oxygen is not sustaining. I am taking Prilosec for the hernia until I can see a GI guy - and that has improved - I still cough because of my lung disease but I'm not having the stomach spasms with the hernia so that is what is improved. G.I. doctor appt coming up. I saw the Pulmonologist and primary care doctor (she is the one that told me to go to ER for my breathing difficulties.) I'm stabilized with the oxygen but not recovered. Things are still being evaluated as far as what kind of recovery to expect. I'm not getting worse.
66 2021-07-10 chest pain Terrible chest pain, shortness of breath, sharp pain in cheek with chewing, loss of voice. Guessing ... Read more
Terrible chest pain, shortness of breath, sharp pain in cheek with chewing, loss of voice. Guessing pericarditis or myocarditis after seeing reports on the news
66 2021-07-13 palpitations Woke up shaking, heart pounding. Had red rash on arm. Got in to see Dr the next day, ecg results ... Read more
Woke up shaking, heart pounding. Had red rash on arm. Got in to see Dr the next day, ecg results warranted an echocardiogram. Results came back with a ruptured cord to a mitral valve leaflet. Have had minimally invasive mitral valve repair surgery on 4/15/2021.
66 2021-07-14 atrial fibrillation Rapid Afib. 06/19/2021 ER
66 2021-07-17 loss of consciousness she was going to pass out; started feeling bad; completely cramping, laid down on the floor until th... Read more
she was going to pass out; started feeling bad; completely cramping, laid down on the floor until the ENT; chills; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (she was going to pass out) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Acid reflux (oesophageal), Rotator cuff injury and Thyroid disorder. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (she was going to pass out) (seriousness criterion medically significant), FEELING ABNORMAL (started feeling bad), MUSCLE SPASMS (completely cramping, laid down on the floor until the ENT) and CHILLS (chills). On 25-Mar-2021, LOSS OF CONSCIOUSNESS (she was going to pass out) had resolved. At the time of the report, FEELING ABNORMAL (started feeling bad), MUSCLE SPASMS (completely cramping, laid down on the floor until the ENT) and CHILLS (chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment products included Pantoprazole 40 mg BID (after vaccine adverse event) Concomitant products included Valsartan HCTZ 160/25 QD Patient said she was informed she might have Vasovagal response. After staying the emergency room for 6 hours all of her blood work and test came back to normal. The heartburn did not change at all. Patient's new GI doctor suggested that she might be experiencing from inflammatory response from the vaccine and suggested to stay on Pantoprazole 40 mg and double the dose. Patient then spoke with her retired GI doctor who said that the vaccine might cause weaken her system and now its compromised. Patient said that her digestive system and quality of life has been affected after the vaccination. Consent to follow up with patient and health care professional given. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-253202 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
66 2021-07-20 hypertension I had an immediate reaction right after the vaccine. I was waiting in the holding room, I had diffic... Read more
I had an immediate reaction right after the vaccine. I was waiting in the holding room, I had difficulity hearing and focusing. I could barely stand and very thirsty. I was given 2 shots of Epinephrine and an ambulance was called. I did not want to go with the ambulance so I stayed behind at the medical office for 6 hours. I finally felt well enough and someone drove me home. My blood pressure was fine at the time. 2 weeks later, I checked my blood pressure and it was high at 190/101. It stayed elevated for 2 weeks and then normalized. About 1 month after the vaccine, I started to notice changes in my vision. I initally visited my PCP to check my blood pressure and also discussed changes in my vision. He did blood work which was normal. So I went to see my optometrist and did an eye exam, which he noted significant changes in my vision. My reading eye sight did not change but my farsightedness had significant changes and I now have to wear glasses for farsightedness. Before I was able see and read signs on the road far away and now I can not. My vision seeing far is very blurry.
66 2021-07-27 blood pressure increased Elevated BP
66 2021-07-27 deep vein blood clot I did get "moderna arm" following 2nd dose but it is the aforementioned issues (VASCULAR) with my LE... Read more
I did get "moderna arm" following 2nd dose but it is the aforementioned issues (VASCULAR) with my LEFT EYE and blood clot in LEFT LEG
66 2021-07-28 enlargement of the heart Following the shot I had a little bit of ache and arm soreness and tiredness and when the reaction h... Read more
Following the shot I had a little bit of ache and arm soreness and tiredness and when the reaction hit, I laid down for a short nap woke up walked to kitchen and couldn't catch my breath. I called my an ambulance and went to hospital the doctor said I had blood clots in both lungs and an enlarged heart.
66 2021-07-28 chest discomfort In 45 minutes I had a rash on my chest, back, and neck. Chest tightness, some shortness of breath. ... Read more
In 45 minutes I had a rash on my chest, back, and neck. Chest tightness, some shortness of breath. First O2 reading was 94%. They gave me Benadryl, 50 mg prednisone, and a breathing treatment. This got it under control. They also drew blood to check levels of histamine. (No results yet). A few hours later I had some more breathing difficulties. 6 hrs after the shot I had hives. Benadryl helped with all of that.
66 2021-07-29 troponin increased, chest pain presented to ED with SOB and substernal chest pain 30 min after vaccne.
67 2020-12-31 chest discomfort 1/1/2021 - Experiencing headache, feeling weird all over. Tightness in chest. comes and goes. ... Read more
1/1/2021 - Experiencing headache, feeling weird all over. Tightness in chest. comes and goes. Will call Doctor on Monday if still feeling the same.
67 2021-01-08 fast heart rate, low blood oxigenation Myalgia, NauseaVomiting, Tachycardia, hypoxia, chills Narrative:
67 2021-01-08 fast heart rate Diarrhea, NauseaVomiting, Tachycardia, tachycardia, NVD approximately 12 hours post injection Narrat... Read more
Diarrhea, NauseaVomiting, Tachycardia, tachycardia, NVD approximately 12 hours post injection Narrative:
67 2021-01-10 blood pressure fluctuation Developed dizziness about 10 minutes after the vaccine injection. BP 161/81 mmHg and no other associ... Read more
Developed dizziness about 10 minutes after the vaccine injection. BP 161/81 mmHg and no other associated signs and symptoms. BP fluctuated 136/84 to 150/87 mmHg. Monitored for another 20 minutes without symptoms.
67 2021-01-12 chest pain, chest discomfort 1420: sitting in chair in general observation area. C/O left arm tingling. Encouraged to move arm an... Read more
1420: sitting in chair in general observation area. C/O left arm tingling. Encouraged to move arm and flex hand. 1424: states that the tingling is moving up her neck and it is throbbing now. Moved to private observation area. States her left arm is sore, throbbing with tingling down arm into hands. C/O soreness up neck and that chest feels heavy. Hx of asthma requiring new monoclonial antibodies started two months ago. BP 138/88; HR 98; O2 sat 97% on r/a. Color pink. States that her BP usually runs under 120 systolic and under 80 diastolic. States her pulse is usually in the 60-70s. No SOB noted. Lungs clear bilaterally, diminished in left lower lobe. Does not have inhalers with her. Denies throat swelling or itching. Gave water and denies difficulty swallowing. 1434: - HR 89; O2 95% on r/a. she drank a fruit smoothie she had in her purse. 1437: - EMT on site arrived for further evaluation. States that her pain in chest is 4/10 and now describes "feels like pressure" and states the pain is radiating up the neck and outward from left chest area. 1440: BP 146/90; HR 90: )2 97% on room air. Speaking without SOB noted. States that pain is now radiating into her left side of back. 1442: EMS 911 activated, clinic manager notified 1446: O2 97% on r/a; HR 87. States pain less throbbing, but still radiating. 1450: Stall have decreased sensation and tingling in left arm. 1455: States pain is now 2/10. State left arm tingling improved. Color remains pink, no SOB noted, No resp. distress noted. 1500: EMS ambulance crew arrived. Patient states pain now 1/10 1504: HR 86, BP 111/73; O2 97% 1508: 12 lead EKG run per EMS. Advised transport to hospital. Patient agreed. 1510: Patient began stating that she did not want to go to hospital. Clinic manager had contacted MD on call and explained to her that he is approving transport due to her symptoms. Patient started talking about being worried about getting back to her car. EMS and clinic manager spoke to her about the dangers of driving self with her symptoms. Reassured that several hospitals can provide taxi or bus vouchers back to her car once evaluated and released. She then began talking about her dog being alone in a crate at home. States she just moved here several months ago and doesn't know any of her neighbors. States her only child lives in a different County and that he currently has COVID. 1515: Refusing transport via EMS 1519: Stood with lightheadedness, no SOB, States she feels fine now. Signed AMA refusal for transport to hospital. 1520: Ambulated down hall with difficulty. EMS left. Walked back to restroom - voided. 1523: Ambulated per self to personal vehicle. Gait steady. No lightheadedness. States chest pain resolved.
67 2021-01-13 chest pain I experienced unusual never felt before Pain in middle of chest lasted approx.3-5 minutes (possible ... Read more
I experienced unusual never felt before Pain in middle of chest lasted approx.3-5 minutes (possible rapid heart rate event) 1 and 1/2 hr. after Moderna vaccine given on 1/12/2021 no more pain after that event. She suggested it might have been a rapid heart rate and to go to doctor to get it checked out. I hope I am filling this form out correctly. I intend to get checked out by doctor soon.
67 2021-01-14 heart rate increased Rapid Heart Beat, dull headache
67 2021-01-16 hypertension I felt light headed and severe headache. My BP was high
67 2021-01-16 palpitations, heart rate increased, chest discomfort Got slightly dizzy as I stood up. Went to sit in observation room. My heart was beating very fast f... Read more
Got slightly dizzy as I stood up. Went to sit in observation room. My heart was beating very fast for about 8 minutes. Felt a tightness in my chest and had a slight bit of difficulty breathing. Did not want to tell the monitors. Afraid to go to a hospital with COVID. My left hand turned blue and got cold and tingly. That lasted for about 2-3 minutes. So did the trouble breathing. All subsided in 15 minutes. Went home and took an antihistamine. Had a light rash on my body. Consulted with PCP and cardiologist. They seem clueless. We all agreed that i need the second dose but what is the antidote. Cardiologist gave me a beta-blocker to take before the dose but these symptoms all appeared on the severe allergic reaction list. The heart pounding was the most pronounced symptom. What do I do?
67 2021-01-19 heart rate increased Became light headed within approx 5 min. It got worse and walking to observation room felt faint. Pu... Read more
Became light headed within approx 5 min. It got worse and walking to observation room felt faint. Pulse rate elevated but attendant said not "critically high." Breathing was normal. After about 20 minutes I started feeling better. Oddly, while sitting in observation room, my sinuses cleared up, and I detected an odd taste at the back of my throat. Developed frontal headache about same time; took acetaminophen and it went away after 12 hours.
67 2021-01-19 palpitations o Patient received covid vaccine at approximately 11:45. She then stated she felt very weak as if sh... Read more
o Patient received covid vaccine at approximately 11:45. She then stated she felt very weak as if she is about to pass out. Also stated that she felt her pulse and her heart was racing. Patient's vitals taken 11:47- BP 191/90, HR 110, O2-99%. Patient took a dose of her home medication DGL (dyglicyride licorice). She states this medication relieves her anxiety and calms her stomach. Patients vitals taken again 11:58 187/80, HR 93 )2-99%. Patient denies any pain. Informed patient that she will be taken to the ED for closer monitoring. Patient verbalized understanding. Patient later stated that she forgot to take her potassium tablet today. I informed her that if she is going to take her potassium pill to please notify the ED nurse and the amount of potassium taken. She verbalized understanding. Patient escorted to the ED via wheelchair in stable condition.
67 2021-01-20 chest discomfort, palpitations Palpitations, chest pressure
67 2021-01-20 hypotension, fainting Pt presented to the ER 1/21/21 for a syncopal episode, approximately 36 hours after injection. She r... Read more
Pt presented to the ER 1/21/21 for a syncopal episode, approximately 36 hours after injection. She reported fatigue and dizziness the evening of 1/20/21, then had a syncopal episode and incontinence of diarrhea at that time. She also had hypotension that was corrected with IVF, lowest BP was 60/45 at 0200 on 1/21/21.
67 2021-01-20 palpitations 7 mins after injection.... heart pounding, throat swelling.
67 2021-01-20 fast heart rate, heart rate increased before/during/after patient experienced tachycardia + "tingling". No rash, no resp. issues. Patient'... Read more
before/during/after patient experienced tachycardia + "tingling". No rash, no resp. issues. Patient's baseline is PR=100. After 3rd set of vitals, well w/in her norms. MD advised patient as to what to expect (eg sore arm) 67 y/o female who presents with raised heart rate and body tingling. Pt thinks it could be anxiety. No vaccine allergies Exam - unremarkable except for tAchycArdiA PlAN - OBS with resolution of symptoms and tAchycARdiA. unlikely to be allergic RXN
67 2021-01-21 chest discomfort Patient complained of Itchy eyes and tightness in her chest.
67 2021-01-23 atrial fibrillation Second part. Took Advil 400 mg and was fine after vaccine. Had at fib at about 10:45 pm and woke up... Read more
Second part. Took Advil 400 mg and was fine after vaccine. Had at fib at about 10:45 pm and woke up with at fib at 2 am 1/24/21.
67 2021-01-23 chest discomfort Initially face turned bright red and started burning. Redness spread to neck and shoulders and star... Read more
Initially face turned bright red and started burning. Redness spread to neck and shoulders and started resembling hives. Had some tingling in lips and tightness in chest, felt light-headed. Paramedics observed and checked vitals. Pulse ox was good, chest clear, BP high. Gave me choice of getting IV or going to drugstore and purchasing benedryl to begin immediately. Started oral benedryl. Went home and took 2nd dose. Redness is subsiding, BP reduced. Still mild light headedness.
67 2021-01-23 heart rate increased Elevated heart rate for approximately 8 hours (normal resting heart rate 52, elevated to 76) Extreme... Read more
Elevated heart rate for approximately 8 hours (normal resting heart rate 52, elevated to 76) Extreme fatigue 24 hours
67 2021-01-25 heart rate increased, chest discomfort Patient felt flushed and dizzy. Per smart watch HR increased to 95 and complained of chest tightness... Read more
Patient felt flushed and dizzy. Per smart watch HR increased to 95 and complained of chest tightness. Symptoms occurred 10-15 mins after vaccine. Benadrl 25 mg orally given. Symptoms resolved. HR decreased to 75. No signs/symptoms of anaphylaxis.
67 2021-01-26 palpitations Racing heart, diarrhea
67 2021-01-27 chest pain, pulmonary embolism, pallor, hypotension, cardiac arrest Patient presented to the Emergency Department complaining of chest pain, pale, cool diaphoretic, an... Read more
Patient presented to the Emergency Department complaining of chest pain, pale, cool diaphoretic, and hypotensive. The patient was discovered to have a large saddle pulmonary embolism, went into cardiac arrest and expired. Of note, the patient received her second Moderna COVID vaccine on 1/23, which would place her first one approximately 12/25 if she received them at the appropriate interval. This information is from the patient's daughter and the ED record, the information is not available in CAIR. Per the daughter, the patient started feeling ill on 1/21, improved on 1/25, and then acutely worsened on 1/27, resulting in the ED visit.
67 2021-01-27 hypertension By afternoon on day of injection 1/18/2021 left arm injection site sore, increased through 1/19/2021... Read more
By afternoon on day of injection 1/18/2021 left arm injection site sore, increased through 1/19/2021. Ringing in ears and elevated BP started 1/19/2021 and lasted one week (150/90 most of the time), low grade temp started on 1/20/2021 until the morning of 1/22/2021.
67 2021-01-28 pallor Blanching red rash, diffuse, spreading out from injection site. Began approx 2 hrs from injection. T... Read more
Blanching red rash, diffuse, spreading out from injection site. Began approx 2 hrs from injection. Treated with OTC Benadryl. Occasional tingling, angioderma around mouth. Disssapated after Benadryl. Rash is gradually fading and requires less Benadryl to keep in check. Had similar reaction to Shrinyx vaccine 2 years ago. Rash lasted 1-2 weeks without Benadryl treatment.
67 2021-01-29 chest pain Began with sweating than pain in upper back between shoulder blades, radiated from back to chest. ... Read more
Began with sweating than pain in upper back between shoulder blades, radiated from back to chest. Tightening of jaw (as when eating something really tart). Pain felt similar to muscle spasms and would be bad enough to cause nausea & vomiting. When pain subsided would experience chills and shivering. This would come and go over the next 5-6 hours. Checked for fever, but temperature was within normal range.
67 2021-01-30 heart rate increased No lot number. Fatigue, 1 day headache, 5 days muscle pain, joint pain, chills, itchy, rash on arm, ... Read more
No lot number. Fatigue, 1 day headache, 5 days muscle pain, joint pain, chills, itchy, rash on arm, rapid heart beat.
67 2021-01-31 chest pain fatigue, sweating, cough, chest pain, shortness of breath, rash on non shot arm, stomach pain, diarr... Read more
fatigue, sweating, cough, chest pain, shortness of breath, rash on non shot arm, stomach pain, diarrhea, ball under injection site, muscle and joint pain, strong chemical smell
67 2021-01-31 pallor I was pale and had a headache then about 7PM became Nauseous. Vomited at 3:30AM 1/29/2021 At 4:25AM... Read more
I was pale and had a headache then about 7PM became Nauseous. Vomited at 3:30AM 1/29/2021 At 4:25AM and also 5:45AM had dry heaves at 8AM severe stomach pain. Friday the day after vaccine I could not get out of bed slept a lot when would get up was dizzy and Nauseous that day only ate 1/4 piece an 2 soda crackers. Saturday I was able to be up for a couple of hours then would have to lie down and rest. That day still had stomach pain gas and bloated feeling. was able to eat chicken nooodle soup . Sunday up most of day had to nap twice symptoms better but still unable to eat much. Tired easily. Today Monday I am much better some stomach pain still can't eat much. I am able to stay up.
67 2021-01-31 palpitations, fainting approx. 24 hours later, got light headed and faint, felt rapid heart beat.
67 2021-02-01 loss of consciousness, hypotension, lightheadedness, fainting 1) fever , and chills, sweats for 24hours (started few hours after the vaccine) 2) passed out around... Read more
1) fever , and chills, sweats for 24hours (started few hours after the vaccine) 2) passed out around 3 am next day when woke up from sleep, Wanted to drink water in kitchen but she felt weak, instead got up to use the bath room to urinate, felt weak, mild dizzy, she made to urinate and when got up after urinate, she fainted. She passed out. Not remember the episode. She woke up (think after short period) looking at ceiling and thinking where she was. Next day, woke up with whole clothes wet from sweating. Denies CP, SOB, diff breath, ting, numb, weak over part of body. 3) had diarrhea for 10 days before this shot. 3 times per day, nausea +, watery, no mucus , blood. No v, Tried Immodium. No BM since 2/2. Likely syncope fr vasovagal vs hypotension fr diarrhea.
67 2021-02-02 palpitations feeling foggy, woozy, a little dizzy and nauseated, racing hearthard to swallow
67 2021-02-03 very slow heart rate, fainting, hypotension, haemoglobin decreased She states "I sat down to get my shot and the next thing I knew everyone was standing over me". EMS... Read more
She states "I sat down to get my shot and the next thing I knew everyone was standing over me". EMS on scene reported that her syncopal spell lasted about 15 minutes after which she was found to be bradycardic and hypotensive.
67 2021-02-03 palpitations Racing heart, lightheadedness, fatigue that lasted 48 hours
67 2021-02-04 fainting, loss of consciousness Loss of consciousness - fainted 18 hours after dose
67 2021-02-04 fast heart rate, blood pressure increased patient was given Moderna vaccine at 5:15 pm, 2 min after Moderna was administered patient had c/o n... Read more
patient was given Moderna vaccine at 5:15 pm, 2 min after Moderna was administered patient had c/o nausea/vomiting, shortness of breath/difficulty breathing, throat irritation and scratchiness. Patient was given Epinephrine 0.3 mg IM into L thigh at 5:17 pm, vitals were taken, patient was tachycardic, tachypneic, and had elevated blood pressure, 911 was called at 5:18 pm. Patient was then taken to ED by ambulance.
67 2021-02-04 fast heart rate, blood pressure increased Tachycardia 180 to 200 rate approximately 36 hours post second dose of vaccine. Extremely sore arm a... Read more
Tachycardia 180 to 200 rate approximately 36 hours post second dose of vaccine. Extremely sore arm at injection site. Pain to jaw. Lump in throat, difficult to get a deep breath. Went to ER, monitored, IV fluids given, increase BP, 170/ 72.
67 2021-02-05 chest pain An hour and a half I became dizzy. Within two hours nausea and diarrhea. For 24 hours could not e... Read more
An hour and a half I became dizzy. Within two hours nausea and diarrhea. For 24 hours could not eat it drink without being sick. Then numbness and tingling in arms and legs. Day two face was numb. nurse saw twitching eyes ,hands and I had it all over. Chest pains when I got up. During the night of day 2 I woke with my entire body trembling. My face was swollen the entire day. Today is day 3. My lips twitch occasionally, my face has an occasional tingle, still have diarrhea and nauseous, I am trying fluids and and I just tried an egg. I feel like I have worms crawling inside my arms and legs. I was told by the pharmacy and school nurse that it would take 3-4 days to feel better. I am healthy and a teacher. This is very concerning.
67 2021-02-05 heart rate increased, hypertension Shortness of breath, tingling sensation starting in legs and slowly moved up my body, rapid heart be... Read more
Shortness of breath, tingling sensation starting in legs and slowly moved up my body, rapid heart beat, high blood pressure, breathlessness, severe uncontrollable shaking
67 2021-02-05 heart rate increased high heart/pulse rate over 180 at 12 noon on Fri the 5th. and lasted for 2 and half hours ... then ... Read more
high heart/pulse rate over 180 at 12 noon on Fri the 5th. and lasted for 2 and half hours ... then heart/ pulse rate finally lowered to 160.. By suppertime its back to normal range 87.
67 2021-02-07 body temperature decreased I am 67 years old female with no health conditions and take no prescribed medication. I had the fi... Read more
I am 67 years old female with no health conditions and take no prescribed medication. I had the first Moderna shot on Friday February 5th st 3:00 pm. By 8:00 that night joint. muscle and skin pain and headache started. The next morning February 6th my temperature dropped to 96 and I had extreme chills all day. That night my temperature was 103.2 , diarrhea and vomiting started with all the previous reactions except chills still there. Sunday morning February 7th, all effects from vaccine still there- joint, muscle, skin pain, headache, diarrhea and vomiting but no fever. Sunday night, fever of 102.4 . Monday morning February 7th, headache and fever are gone but extremely weak and body aches still here. My question to you is "With such a reaction to the first shot, should I get the second one? "
67 2021-02-07 hypertension Pt initially reported feeling tingling sensation of lips and, "eyes feeling tight". Then pt states s... Read more
Pt initially reported feeling tingling sensation of lips and, "eyes feeling tight". Then pt states she had throat tightness. She was given crackers, juice but she said it was difficult to swallow. Per RN documentation "Pt continued to complain of lips slightly feeling numb and diffuse tingling sensation. IM Benadryl administered at 1840 with improvement, pt reported "numbness improving" and "eyes feeling back to normal". After further observation, pt c/o difficulty swallowing, rapidly became anxious and reported SOB. EPI pen administered at 1902, supplemental O2 provided with improvement." Pt brought to the ED by paramedics Per ED MD "Upon arrival, patient mildly hypertensive, no stridor, speaking in full sentences, no wheezing, clear lungs bilaterally. Based on history exam, concern for allergic reaction vaccine" Tryptase not drawn.Pt discharged in good condition
67 2021-02-07 hypertension Just as the nurse started injecting the vaccine I felt a strong taste of metal in my mouth (similar ... Read more
Just as the nurse started injecting the vaccine I felt a strong taste of metal in my mouth (similar to the times I have had CAT scans done). In a couple of minutes I felt very light headed. While scheduling my second dose, I started feeling strong pressure inside my head. I didn't not feel any pain, just a lot of pressure. When measuring my blood pressure (usually, in my case, it is 120 X 80) I was told my high number was at 178 x 80. After resting for some 20 minutes, I was fine again and drove home. I felt a bit strange for a couple of hours.
67 2021-02-07 palpitations approximately 11 hours post vaccination, symptoms of headache and body aches. this was followed by s... Read more
approximately 11 hours post vaccination, symptoms of headache and body aches. this was followed by shivering, weakness and a pounding heart. This continued for five to six hours. The shivering eased, leaving the pounding heart, terrible headache and body aches, especially in the neck and shoulders area. These remaining symptoms continued into day two.
67 2021-02-07 transient ischaemic attack TIA ~ found slumped in chair, aphasic, unable to stand. sent to local hospital emergency room
67 2021-02-08 blood glucose increased Extremely sore muscle at injection site, fatigue, joints hurting occasionally (although with fatigue... Read more
Extremely sore muscle at injection site, fatigue, joints hurting occasionally (although with fatigue I'm not moving much),fever 99.4 - 100.7, and blood sure elevated between 162 and 190. Don't know of any other reason for it to be this high. Had sleepless night and then 4:00 a.m. blood sugar was 190. Blood sugar is what I'm most concerned about.
67 2021-02-08 enlargement of the heart, chest pain, troponin increased, chest discomfort History of Present Illness: Patient is a(n) 67 Y female with a PMH of asthma, HTN, HLD, GERD who arr... Read more
History of Present Illness: Patient is a(n) 67 Y female with a PMH of asthma, HTN, HLD, GERD who arrived to the ED via rescue squad with complaints of sudden onset of squeezing chest pain/tightness that radiated to the back, associated dyspnea, lightheadedness and dizziness that began around 6:30PM. Pt reports she was feeling well prior to the episode and she had her COVID 19 vaccine at 4:30PM and had tolerated the vaccine well. She does report that she had atrial fibrillation before, about 5 years ago and she underwent a cardiac work up. She denied palpitations, fever, chills, body aches, nausea, or vomiting. She does have a non productive cough. Her BP normally runs 130/80's at home and is controlled w amlodipine. She was given SL nitro and aspirin in the ambulance. EKG showed atrial fibrillation with RVR, HR 150's. Reason for admission: Atrial fibrillation with rapid ventricular response (*) Atrial fibrillation with RVR (*) She was admitted for further evaluation and monitoring. Troponin level noted to be 0.79 and EKG with ST-T wave changes, cardiology was consulted and patient underwent cardiac cath who revealed no significant CAD hyperdynamic LVEF 70 %. She developed a small hematoma post catheterization which has resolved. Cardizem was switched to metoprolol and both BP and HR are improved and controlled with losartan. Pt without any adverse effects to losartan, no s/s angioedema. Afib with an abrupt onset and abrupt return to normal sinus rhythm. She complained of calf pain, US dopplers were obtained and were negative for DVT. Her D Dimer was also normal. Pt discharge to home in stable condition.
67 2021-02-08 chest pain 20 min after inj-itching, hives, lip and eyelid swelling, chest pain, neck pain, pain radiating down... Read more
20 min after inj-itching, hives, lip and eyelid swelling, chest pain, neck pain, pain radiating down spine and to the legs, nausea, no vomiting, headache, treated Epinephrine, solumedrol, Benadryl, ambulance was called, but pt felt better and refused and stayed in clinic for observation, then d/c home
67 2021-02-09 cerebrovascular accident Cerebral stroke. Symptoms onset was documented by nursing home staff on 1/13/21. Second dose of vacc... Read more
Cerebral stroke. Symptoms onset was documented by nursing home staff on 1/13/21. Second dose of vaccine was received on 1/12/21. I am unsure at this time if it was the Pfizer or Moderna vaccine. Patient has severe defecits at this time but the brain is still healing. Several weeks in the hospital, patient now has peg tube and picc line. Flaccid right side and speech severely impacted.
67 2021-02-09 chest discomfort, stroke, atrial fibrillation, heart rate increased Chest discomfort with high heart rate and shortness of breath, dizzy upon standing. In ER HR was 156... Read more
Chest discomfort with high heart rate and shortness of breath, dizzy upon standing. In ER HR was 156 with atrial fibrillation with RVR. BP 146/89. 2/7/21 1546 - Patient complaining of left side peripheral field deficit, CT showed subacute right occipital lobe infarct
67 2021-02-10 hypertension Moderna Vaccine - hypertensive to 220
67 2021-02-13 chest discomfort At end of 15 minute observation she became, " little lightheaded." Gave patient some water. She th... Read more
At end of 15 minute observation she became, " little lightheaded." Gave patient some water. She then felt better, but return shortly after discharge complaining of chest tightness. VSS, physical exam and EKG normal. Advised ED evaluation but pt refused and signed AMA. After further observation she felt better and requested discharge. VSS on discharge.
67 2021-02-14 loss of consciousness Woke up with sore left arm, weak and had chills. Passed out in the bathroom at 9 pm 2/13/21, hit hea... Read more
Woke up with sore left arm, weak and had chills. Passed out in the bathroom at 9 pm 2/13/21, hit head and injured shoulder. Did not feel faint-like prior tp passing out.
67 2021-02-14 oxygen saturation decreased, inflammation of the pericardium, atrial fibrillation feeling much worse; Bloodwork with elevated parameters (troponins); Couldn't take food; Couldn't get... Read more
feeling much worse; Bloodwork with elevated parameters (troponins); Couldn't take food; Couldn't get up from bed; Fever (101°F); Atrial fibrillation; Pericarditis; A spontaneous report was received from a non-healthcare professional concerning a 67-year-old, female patient who developed a fever of 101 degrees Fahrenheit, feeling much worse, couldn't take food, couldn't get up from bed, bloodwork with elevated troponin, pericarditis, and atrial fibrillation. The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included Pentasa, metformin, insulin, Zoloft and atorvastatin. The patient received their first of two planned doses of mRNA-1273 (lot number 028L20A) on 20 Jan 2021 in the right arm for prophylaxis of COVID-19 infection. The patient developed a fever on 25 Jan 2021, and it got up to 101 degrees Fahrenheit on 26 Jan 2021. On 26 Jan 2021 she felt must worse, couldn't take food, and couldn't get up from bed. On 27 Jan 2021, she was taken to the emergency room where her oxygen saturation was low, but the fever was gone. She was placed on oxygen, and blood work had elevated troponin. The patient was diagnosed with pericarditis and she was kept overnight. On 28 Jan 2021 she had atrial fibrillation and the medical team couldn't convert her chemically. She was stabilized on 30 Jan 2021 and she was feeling much better. Treatments of these events included oxygen and ibuprofen. The events, fever of 101 degrees Fahrenheit, feeling much worse, couldn't take food, couldn't get up from bed, bloodwork with elevated troponin, pericarditis, and atrial fibrillation were considered Recovering.; Reporter's Comments: This case concerns a 67 year old female who experienced serious unexpected events of feeling abnormal, decreased appetite, bedridden, elevated troponin, pericarditis, and atrial fibrillation, and a serious expected event of fever. The events began 6 days after first dose of mRNA-1273. Treatment with ibuprofen. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
67 2021-02-14 lightheadedness received the 2nd vaccination of Moderna on 2/12 930a on 2/13 at 11a started to feeol diczzy - try to... Read more
received the 2nd vaccination of Moderna on 2/12 930a on 2/13 at 11a started to feeol diczzy - try to make it the bed but able to do so ended up part on bed and part on floor - unable to move - could hear things around me - the tv was on - I could feel the sweat drops coming off my face - (it felt like I was "locked in" - term used when coma pts can hear but able to move - I could feel the chills down my back - this lasted about 1/2 hr then started to be able to feel myself coming around - the whole time I kept telling myself to take slow deep breaths- the entire episode lasted about 1 1/2 -2hr - felt low energy after that - following morning felt back to normal
67 2021-02-15 blood pressure increased, heart rate increased Bp increase usually normal 140/94, pulse 94 ;154/88 pulse 102, 146/99 pulse 101
67 2021-02-15 blood pressure increased About 25 minutes after receiving injection the left side of my face began tingling and feeling numb ... Read more
About 25 minutes after receiving injection the left side of my face began tingling and feeling numb (sort of like numbing at the dentist). 5 1/2 hours later (8:45 PM) the left side still feels numb. Felt like a beginning of a headache at the top of my head - has not progressed further than that. With home equipment: oxygen level 98, pulse 82. BP 154/78 (usually about 146/70
67 2021-02-15 heart rate increased Injection was extremely painful. about 3-4 minutes after injection got very dizzy and flushed. Red ... Read more
Injection was extremely painful. about 3-4 minutes after injection got very dizzy and flushed. Red face and pressure behind eyes. Heart rate jumped to 150 and stayed above 125 for several minutes. I could barely walk back to vaccination area where pharmacist waited with epipen. I was given water and after a few minutes HR went below 100. I stayed another 30 minutes and left however I did still feel a bit dizzy. At about 8 hours post injection got chills and fever of 101.5 and HR remained high (above 102) for at least 6 hours after onset of fever. Resting HR usually 59 and still remains above 90 at 48 hours.
67 2021-02-16 chest discomfort Starting late 2/4 Body Ache, Tightness in Chest. Body Ache went away 2/6, tightness in chest improv... Read more
Starting late 2/4 Body Ache, Tightness in Chest. Body Ache went away 2/6, tightness in chest improved. 2/1o Tightness in Chest came back. Went to Dr. Was given steroid shot, zpac, and breathing treatments. EKG was done. Returned to Dr, 2/12. Breathing better. Another EKG was done, little change. Went to Cadiologist on 2/15. Will have nuclear stress test on 2/18. Cardiologist feels that this is not heart or lung related based on consultation, thinks that it is Covid related.
67 2021-02-16 loss of consciousness Patient passed out in the middle of the night...not at site and hours after the dose was administere... Read more
Patient passed out in the middle of the night...not at site and hours after the dose was administered.
67 2021-02-16 palpitations, fainting Patient experienced syncope, dizziness, respiratory distress, palpitations. BP 132/67, pulse 60.
67 2021-02-16 fainting Pt vaccinated at 4:30 pm for first dose. Left CHD did normal daily activities. Went to bed that even... Read more
Pt vaccinated at 4:30 pm for first dose. Left CHD did normal daily activities. Went to bed that evening woke up around 3 am on 1/16/21 extreme pain to left arm, diaphoretic, chills, weakness. Went to stand up and started experiencing vertigo. Made it to restroom, was able to void, went to stand up and found herself waking up on the floor. Had redness and swelling to right cheek, ecchymosis to right eye, and found abrasion to left posterior head. Stated it took 48 hours for the weakness and fatigue to go away. Pt did not seek medical attention right away however did contact her PCP and make aware of occurrence. Was given the ok per PCP to receive second vaccine.
67 2021-02-16 fainting The day after my injection, at 5:00 a.m. I got up to try to go to the bathroom but felt very dizzy -... Read more
The day after my injection, at 5:00 a.m. I got up to try to go to the bathroom but felt very dizzy - I had help to get to commode but had to lie on floor to stop from passing out, was sweating profusely. Did not feel well between 5 and 8 am. I think I had 2 vasovagal episodes during this time brought on by needing to do a bowel movement but I had difficulty not passing out. After second bowel movement - the dizziness and nausea and sweating subsided. The rest of the day, I just had minor fever and minor headache. By the next day I was normal. I have had 2 or 3 vasovagal episodes in the last 15 years and so that is what I think it was but I assume possibly brought on by the vaccine. My average sleeping heart rate that first night was 10 beats per minute higher than normal (I wear a Fitbit with a sleep app).
67 2021-02-17 blood pressure increased Within a few minutes of the vaccine she could taste and smell a very strong medicine taste. She did... Read more
Within a few minutes of the vaccine she could taste and smell a very strong medicine taste. She did not notice until after another 10 minutes that her face was on fire. She looked in the mirror and her face was red, much more on the left than the right. It would decrease in intensity and then flare up again. She then went to the doctor, tried to wait out getting into the doctor, but then decided to go to the ER. Her blood pressure was 187/181, yesterday was 112/64. They gave her a stronger Benadryl and Pepcid, monitored her and did her oxygen level which was 97%. All other VS were normal. Today, 2/18/21 the redness was gone by 10:00 the night of the vaccine. Over the last 24 hours she has had a mucousy cough, and clearing of the throat, but otherwise feels back to normal.
67 2021-02-17 chest discomfort, blood pressure increased, heart rate irregular Pt reported heaviness in her chest, BP 166/88, pulse erratic, slight nausea. Spoke with pharmacist ... Read more
Pt reported heaviness in her chest, BP 166/88, pulse erratic, slight nausea. Spoke with pharmacist we agreed to continue monitoring for 15 extra minutes. After 30min patient symptoms remain with elevated BP and heaviness in chest, patient was sent to ED for evaluation
67 2021-02-17 chest discomfort s/p vaccine administration c/o dizziness, chills, chest tightness. No intervention required
67 2021-02-17 palpitations, cardiac arrhythmia AFter lst dose 12/29/2020 Lt Arm- whole lt arm sore, unable to lay on lt side in bed; then developed... Read more
AFter lst dose 12/29/2020 Lt Arm- whole lt arm sore, unable to lay on lt side in bed; then developed lt shoulder to fingers felt numb & heavy that I have to use rt arm to move lt arm & unable to make a fist with lt hand This continued on for daily until I received my 2nd dose- Moderna#02L20A on 1/26/2021- then rt arm sore & heavy from elbow to rt fingers but able to raise rt arm & continued on but as of today rt arm better UNLESS I take 1000mg Acetaminophen @0500am wait 45min-lhr unless heaviness both arms subside & able to make a fist; also my legs from knee down felt like 'cement'hard to move & get up from BR commode until I ingest Acetaminophen. Rt arm better by 40% than previous but lt arm still about 20% better until I take Acetaminophen Also had nausea & dizziness on 2/9-that my pcp sent me to ER 2/10 due to arm issues & hx heart-labs all normal; troponin-not detected; CXR-WNL; EKG-having Quadrigeminy/Trigeminy with nause/dizziness-placed on Ziopatch x1week-just mailed 2/17 for result; also appt for myocardial perfusion scan 2/23
67 2021-02-19 blood pressure increased Patient has generalized anxiety disorder .Onsite EMS was called they woke the up vitals BP 180/80 ... Read more
Patient has generalized anxiety disorder .Onsite EMS was called they woke the up vitals BP 180/80 100% O2 room air HR 80. Patient Refused Evaluation/Care, Left aginst medical advice.
67 2021-02-19 blood pressure increased 2 hours after shot, arm soreness, mild sore throat, headache, almost whole body soreness. the next d... Read more
2 hours after shot, arm soreness, mild sore throat, headache, almost whole body soreness. the next day they soreness got worse, it hurt to try and walk, headache got worse, 3rd day felt better. On 11th day the headache returned and the arm was sore and weaker. It arm started getting a hot red rash, about 3 in round, skin was hard and hot and itchy, had some body aches and bad headache. Due to holiday, went to urgent care, the red rash had grown to about a 6in oval growing around my arm, mild itch, haedache and soreness, arm was weak, my blood pressure was elevated., not normal. Was told this is covid arm, dr more concerned about blood pressure. Today is 14 days after the 1st vaccine, still have the large rash around my arm, arm is warm, not hot, rash has grown, not itchy. headache is mostly gone. Some body aches, especially in the legs and neck. Arm where got the shot is a little weak still. I will not be getting the 2nd vaccine.
67 2021-02-19 chest discomfort Approximately 14 hrs later pain in arm, chills, headache, nausea, stomach discomfort, heavy chest, s... Read more
Approximately 14 hrs later pain in arm, chills, headache, nausea, stomach discomfort, heavy chest, slight fever, joint aches and fatigue
67 2021-02-20 heart flutter Same already said
67 2021-02-20 palpitations Palpitations. Pain at vaccine site, left upper arm. Extreme pain on left arm from vaccine site to el... Read more
Palpitations. Pain at vaccine site, left upper arm. Extreme pain on left arm from vaccine site to elbow, left scapula, left side of neck and ear; extreme headache originating on left side of head. Extreme pain on both legs causing walking difficulties. Generalized malaise, nausea, lack of appetite, and extremely tired.
67 2021-02-21 blood pressure increased got vaccine at 9:45 , 5-6 minutes later on waiting room, started having tingling on my face , got b... Read more
got vaccine at 9:45 , 5-6 minutes later on waiting room, started having tingling on my face , got blurry vision , and felt weak, started having fine tremors , my hands became so cold . nurse was called , they took me back . my blood pressure got rose to 155 mmhg and o2 sat 99% . my blood pressure was up for 20 minutes . Then kept me there for one hour , then I had another episode of blurry vision , cold handed and fine tremor. They checked my blood pressure which was uyp again . then I took tylenol and a physicien over there recommended benadryl 25mg po which i took it. then around 1 pm i had another episode of coldness and weakness which was not intense and severe as the first time and resolved on her own in 10 minutes . then they let me leave . of fnote , My left arm got swollen but no redness. swelling resolved in 2 days . meanwhile I continued to have weakness,fatigue and subjective fever for next 48 hours .
67 2021-02-21 chest discomfort Chest tightness developed on day 3, intensity varies but is present constantly and has increased thi... Read more
Chest tightness developed on day 3, intensity varies but is present constantly and has increased this morning (02/22/2021). Unusual sensation on tongue. These are the same symptoms I had when experiencing an allergic reaction to Repatha in Oct/Nov 2020. Those symptoms subsided after a month.
67 2021-02-21 heart rate increased, palpitations Throat was closing up, had heart palpitations and trouble catching her breath; alarmed her that her ... Read more
Throat was closing up, had heart palpitations and trouble catching her breath; alarmed her that her heart was beating fast.
67 2021-02-21 blood clot diarrhea low gas pain chills / sweating dry mouth ... Read more
diarrhea low gas pain chills / sweating dry mouth sleepy no apatite cough with phlegm dizzy loss of bladder control blood clots in nose mucus
67 2021-02-22 blood pressure increased, heart rate increased Blood pressure jumped high. Heart rates speedy over 100 beats/min. Dizzy all the time. Constantly co... Read more
Blood pressure jumped high. Heart rates speedy over 100 beats/min. Dizzy all the time. Constantly coughing.
67 2021-02-22 chest pain Headache for 8 days, shooting pains in head and all joints for 2 days, every muscle in body for 8 d... Read more
Headache for 8 days, shooting pains in head and all joints for 2 days, every muscle in body for 8 days so far. Pain in entire chest area left side from neck to waist on 6 & 7th day. Left arm is painful...big red blotch by injection site getting bigger everyday. On 7th day pain in left arm/chest area increased with numbness, heaviness & tingling.
67 2021-02-23 blood pressure decreased, pallor, fainting Short of Breath, Dizzy, Pale, Low BP and Heart Rate, Syncope, Nausea.
67 2021-02-23 blood pressure increased, heart rate decreased, pallor heart rate was low; pupils looked tiny; no color on face, pale; speech was completely slurred; afrai... Read more
heart rate was low; pupils looked tiny; no color on face, pale; speech was completely slurred; afraid she was going to die; head and hands felt heavy; extremely tired, could barely lift a glass; Blood pressure went way up; felt groggy; back pain; back spasms alternating with throbbing in her back that was quite significant; A spontaneous report was received from a (Reporter like HCP or Consumer) concerning a – Years-old male/female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced back pain, back spasms alternating with throbbing in her back that was quite significant, pain was so horrific, blood pressure went way up, spasms continued, went into a deep sleep, felt groggy, feeling extremely tired, very motionless all night, thought she was in a coma, pupils looked tiny, no color on her face, was pale, so fatigued, could barely lift a glass, heart rate was low, never felt anything like that before, speech was completely slurred, truly afraid she was going to die, could barely move her hand from sofa, head felt really heavy,hands felt really heavy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10:12 am 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the left upper arm for prophylaxis for COVID-19 infection. On 6/Feb/2021, The patient experienced back pain, back spasms alternating with throbbing in her back that was quite significant. On 7/Feb/2021,The patient experienced, pain was so horrific, blood pressure went way up, spasms continued, went into a deep sleep, felt groggy, feeling extremely tired. On 8/Feb/2021,The patient experienced very motionless all night, thought she was in a coma, pupils looked tiny, no color on her face, was pale, so fatigued, could barely lift a glass, heart rate was low, never felt anything like that before, speech was completely slurred, truly afraid she was going to die, could barely move her hand from sofa, head felt really heavy,hands felt really heavy. Treated with Baclofen, IV with morphine, Tylenol, Motrin, back patch with lidocaine. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events were unknown.; Reporter's Comments: This case concerns a 67-year-old female who had a serious unexpected event of Heart rate decreased with NS unexpected blood pressure increased, pallor, miosis, dysarthria, back pain, muscle spasms, discomfort, somnolence, fear of death and NS expected fatigue. Event onset 1 day after first dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
67 2021-02-23 chest discomfort On 02/23/21, 67 yo F presented to clinic for dose #2 of COVID-19 vaccine (Moderna). On 01/26/21, aft... Read more
On 02/23/21, 67 yo F presented to clinic for dose #2 of COVID-19 vaccine (Moderna). On 01/26/21, after receiving dose #1, pt experienced an allergic reaction. For second dose, pt pre-medicated with diphenhydramine. At 1537, pt was administered 0.5 mL in left deltoid (lot #024M20A). Within 10 minutes of injection, pt developed cough, chest tightness and itching. Pt was administered epinephrine 0.3 mg IM, albuterol 2.5 mg via nebulization, methylprednisolone 125 mg IV and diphenhydramine 50 mg IV. Due to pt's previous reaction, pt was transported to ED for additional monitoring. EMS administered famotidine 20 mg IV. On arrival to ED, pt was placed in observation. Due to persistent coughing and sensation of throat closing, pt was given second doses of epinephrine 0.3 mg IM , albuterol nebulization and diphenhydramine 25 mg PO. Pt was then held in observation x 4 hours with return to baseline. and no symptom recurrence. Pt discharged with instructions to return to ER for any symptom recurrence.
67 2021-02-23 fainting woke up this morning and fainted
67 2021-02-23 low platelet count, blood clot Vaccine administered 02/08/2021 , by Thursday 02/11/2021 patient almost nonverbal, by Monday 02/15/2... Read more
Vaccine administered 02/08/2021 , by Thursday 02/11/2021 patient almost nonverbal, by Monday 02/15/2021 patient went to the hospital with bruising, sores on her stomach and clots reported as thrombocytopenia, deceased by Friday 02/19/2021.
67 2021-02-24 blood pressure increased Blood pressure spike wouldn?t come down, rash on neck face and chest, happened with in 10 minutes of... Read more
Blood pressure spike wouldn?t come down, rash on neck face and chest, happened with in 10 minutes of the shot. NP gave me a shot of 50mg of Benadryl monitor me for 1 1/2 hrs. Blood press was still high. Had taken my BP meds in the morning. I called my doctor from the parking lot. Had epi pen ready if needed.
67 2021-02-24 heart flutter 8:55 patient complained of feeling anxious, fluttering in chest per patient this is not new, history... Read more
8:55 patient complained of feeling anxious, fluttering in chest per patient this is not new, history of Mitral valve prolapse, Diabetes mellitus and COPD. Lost her spouse on this day, feeling anxious. 9:15- 128/60 Pulse 84, respiration 70, 97% saturated Patient denied chest pain or shortness of breath. No sign of distress observed. 9:30 -Patient instructed to call EMS for chest pain and shortness of breath, fluttering, contact Primary care provider. Patient verbalized understanding and drove home.
67 2021-02-24 chest discomfort Note from observer, RN: 0836am at 15 min. check patient with complaint of some slight chest pressure... Read more
Note from observer, RN: 0836am at 15 min. check patient with complaint of some slight chest pressure while in observation post COVID Vaccination. States this has happened previously with nervousness during vaccinations. At time of discussion reports pressure was better. BP 127/79/Pulse 70. Denies symptoms at this time. Patient agreed to remain additional 15 min. At 0851 am, patient denies any symptoms. At 0852 ampatient left on own.
67 2021-02-24 hypotension I received this vaccine at a walk-in-clinic, called STAT Med. About 12 hours after receiving the va... Read more
I received this vaccine at a walk-in-clinic, called STAT Med. About 12 hours after receiving the vaccine I felt nauseated but finally managed to sleep. The next afternoon on February 23 I became very ill with vomiting and diarrhea all at the same time. I nearly passed out several times. First responders arrived and found my blood pressure to be about 70/30. Got in ambulance and given fluids. Arrived at hospital around 5:15 pm. Got more fluids and numerous blood tests, none of which were very remarkable. My WBC was 17 but nothing else was wrong. Left hospital at 9:00. Physician assumes Covid vaccine cause these side effects.
67 2021-02-24 loss of consciousness S/P Covid Vaccine 1st dose, pt alert/oriented, calm, answering Covid questions appropriately. Prior ... Read more
S/P Covid Vaccine 1st dose, pt alert/oriented, calm, answering Covid questions appropriately. Prior to vaccine. pt reports she doesn't really like vaccines. Vaccine administered at approx 2:34 pm. Pt reports she doesn't feel well, reports she did not eat or drink today. This nurse gave her water to drink. Pt unable to drink, briefly passed out in chair approx 2:36pm. Myself and RN lowered pt from chair to floor. Site Director called EMS. RN assisted by raising pt's legs above heart level. RN checked b/p 70 palp, pts airway maintained, rechecked b/p 80 palp. As pt returned to consciousness reports she is about to vomit, assisted pt to (R) side >vomited small amount clear liquid x2 into bag provided, pt reports she feels better. EMS arrived, transported pt to ED via stretcher @ 2/40 pm, pt's coat, eye glasses, and purse placed on stretcher with pt. Phamacist contacted pt's husband at 2:40 pm. Site Director notified.
67 2021-02-25 palpitations, blood pressure decreased Vaccine given in afternoon. Patient felt heart palpitations during that night. Blood pressure was ... Read more
Vaccine given in afternoon. Patient felt heart palpitations during that night. Blood pressure was 95/53; low for this patient. Two hours later everything was fine. Moderna Lot #016M20A
67 2021-02-25 palpitations From approx 10 pm to 9:00 pm 2/24/21 I experienced the following: Severe headache, nauseousness, vo... Read more
From approx 10 pm to 9:00 pm 2/24/21 I experienced the following: Severe headache, nauseousness, vomiting, heart palptations, Chills and body ache, so much that all my teeth hurt. All symptons left as fast as they came on.
67 2021-02-25 fast heart rate left side of face began to tingle and be numb; left side of face began to tingle and be numb; 2 epis... Read more
left side of face began to tingle and be numb; left side of face began to tingle and be numb; 2 episodes of rapid heartbeat; burning in arm; lips and tongue started swelling; tongue started swelling; severe headache; A spontaneous report was received from a consumer reporting on herself, a 67-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced left side of face began to tingle and be numb/MedDRA PT: Hemiparesthesia, rapid heartbeat/MedDRA PT: tachycardia, burning in arm/MedDRA PT: vaccination site burning, lips started swelling/MedDRA PT: swelling of lips, tongue started swelling/MedDRA PT: swelling of tongue, severe and headache/MedDRA PT: headache. The patient's medical history included allergy to latex and reaction to oseltamivir phosphate (Tamiflu).Products known to have been used by the patient, within two weeks prior to the event, included losartan, potassium citrate, diltiazem, allopurinol, atorvastatin, famotidine and levocetirizine. On 12 Feb 2021, the patient received the first of two planned doses of mRNA-1273 ([LOT# 015M20A]) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Four minutes after the vaccination, the patient felt burning in her arm and the left side of her face began to tingle and feel numb. In addition, the patient's lips and tongue began to swell and she had 2 episodes of rapid heart rate. Within 20 minutes it started to resolved and then she developed a severe headache. On 13 Feb 2021, the patient reported that all of the symptoms were back except the fast heartbeat. The patient called Urgent Care and was prescribed treatment with diphyendramine and famotidine. On 14 Feb 2021, the patient went to the emergency room and received a steroid injection, "liquid to drink", and steroid medication for 5 days. She reported a history of a similar reaction to oseltamivir phosphate (Tamiflu). Action taken with mRNA-1273 in response to the events was not reported. The outcome of events of left side of face began to tingle and be numb, 2 episodes of rapid heartbeat, burning in arm, lips and tongue started swelling and severe headache (12 Feb 2021) were considered recovered/resolved. The outcome of events of left side of face began to tingle and be numb, burning in arm, lips and tongue started swelling and severe headache (13 Feb 2021) were considered unknown; Reporter's Comments: This case concerns a 67-year-old female, with latex and drug allergies, who had serious unexpected hemiparesthesia and hypoaesthesia, NS unexpected lip swelling, swollen tongue, tachycardia, and NS expected vaccination site pain, headache. Event onset 4 minutes after first dose of mRNA-1273. Treated with Benadryl and steroids. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
67 2021-02-25 fast heart rate tachycardia, SOB, chills x 7 minutes. Pt given water and snack and recovered. Pt refused EMS transpo... Read more
tachycardia, SOB, chills x 7 minutes. Pt given water and snack and recovered. Pt refused EMS transport to emergency department.
67 2021-02-25 blood clot MODERNA COVID-19 VACCINE EUA Patient's arm was sore after injection and later that evening pain spre... Read more
MODERNA COVID-19 VACCINE EUA Patient's arm was sore after injection and later that evening pain spread down to her elbow. In the following days she states that it spread to her fingers and included temporary numbness which resolved in a short period of time. Her arm remained sore with warmth and redness about the size of a quarter at the injection site. The warmth, redness and pain did not resolve so she went to the emergency room today.
67 2021-02-26 atrial fibrillation Swollen tongue; severe nausea; golf ball-size swelling at injection site; joints aching; severe head... Read more
Swollen tongue; severe nausea; golf ball-size swelling at injection site; joints aching; severe headache; temperature of 97; difficulties swallowing; A-Fib.
67 2021-02-26 pallor, pallor 1 minute after vaccination, pt felt dizzy, pale, diaphoretic. Also had bleeding and bruising at site... Read more
1 minute after vaccination, pt felt dizzy, pale, diaphoretic. Also had bleeding and bruising at site. Vital signs stable. Given water and granola bar. Band-aid applied to site. Monitored x 30 minutes and released without further symptoms
67 2021-02-27 hypotension About 5 minutes after receiving the shot, my upper lip started tingling. Then both upper and lower l... Read more
About 5 minutes after receiving the shot, my upper lip started tingling. Then both upper and lower lips were tingling. I could drink ok, so no problem swallowing. They took my blood pressure at the time and it was 104/55. I have low blood pressure but that was lower than normal. I stayed for 30 minutes and the tingling would come and go. They did offer to call an ambulance but I declined. I got up this morning and have 2 welts on my forehead and the left side of my lips are still tingling, and occasionally the right side. I will call my doctor tomorrow morning.
67 2021-02-28 loss of consciousness ?Moderna COVID-19 Vaccine EUA? I got up at approximately 9:45 am on 2/28/2021 and went in to use the... Read more
?Moderna COVID-19 Vaccine EUA? I got up at approximately 9:45 am on 2/28/2021 and went in to use the bathroom, After I finished I was washing my hands and suddenly felt a wave of nausea. I gripped the sink and next I knew I woke up on the floor. I suffered severe bruising from the fall. Only other side effects I had were a slight headache and chills a few hours after this incident.
67 2021-02-28 pallor RN was staffing a Covid clinic at HS. One of our other nurses gave her the 1st Moderna vaccine at 1:... Read more
RN was staffing a Covid clinic at HS. One of our other nurses gave her the 1st Moderna vaccine at 1:45 PM on 2/12/21. At 1:55 PM, the nurse who had given her shot noticed that patient was pale, and said she was not feeling well. Her BP was 179/110, and she said she usually has low BP. She c/o of "feeling hot and was having difficulty breathing." She was seen by our medical director. After 30 minutes, her BP was 120/82. She said she ?felt a little better and called her sister to pick her up.? Later that evening, patient texted me saying I didn?t feel well when I got home, had trouble focusing literally and had a crying jag and felt shaky on the inside. I kept hydrating, took 25 of Benadryl and slept for 2 hrs., now feel close to normal. It was definitely a reaction to the shot-just weird!? Patient texted me on 2/13/21 that ?the FDA thinks one vaccine may be enough for 80?90% effectiveness, so I might not get the 2nd dose? On 2/15/21 patient texted, ?My PCP thinks what I had was a side effect & recommends taking Benadryl, Zyrtec, or Tylenol before the 2nd injection, and doesn?t seem to be worried about it!? On 2/19/21, I received a text from patient at 5:28 AM as she was scheduled to staff a Covid clinic that day, beginning at 7:30 AM. She said, ?I have been up for a couple hrs w/severe eye pain and can?t hardly open my eye but it hurts to close it too! At 10:37 AM she texted, ?I just got home from eye doctor and was prescribed drops 4X/day. Apparently, there are pin holes in my sclera & cornea which hurt so bad I had lavender cold pack on all day & couldn?t stand the light. It is a corneal abrasion & I have no idea why that would happen suddenly?. The following day, she texted me a picture of her L arm injection site which she said was ?very itchy and hot! Not painful-? It was about 6 inches in diameter, red, inflamed, delayed cutaneous rx.
67 2021-02-28 palpitations, chest pain Developed chest pain, heart racing, hot, sweaty, nauseous, feeling faint. Lost consciousness. E... Read more
Developed chest pain, heart racing, hot, sweaty, nauseous, feeling faint. Lost consciousness. Evaluated by EMS-regained consciousness, c/o nausea, vitals done. Placed on stretcher, EKG done -HR 50, rhythm sinus bradycardia. Transported to emergency room via rescue squad.
67 2021-03-01 heart rate increased Two minutes after shot, I felt a flush go through me and felt tingly. My heart rate increased and la... Read more
Two minutes after shot, I felt a flush go through me and felt tingly. My heart rate increased and lasted several minutes.
67 2021-03-01 heart rate increased Elevated heart rate within 2 minutes of vaccination, lasting approximately 10 minutes, then subsidin... Read more
Elevated heart rate within 2 minutes of vaccination, lasting approximately 10 minutes, then subsiding
67 2021-03-01 hypertension UNKNOWN COVID VACCINE BRAND. 67 y.o. female presenting to the emergency department with a chief comp... Read more
UNKNOWN COVID VACCINE BRAND. 67 y.o. female presenting to the emergency department with a chief complaint of right sided numbness onset 2000 last night. Patient received her first dose of the COVID-19 vaccine at 1200 yesterday. She states she was feeling okay prior to 2000. Patient states she then developed numbness to the right side of her head, right arm, and right leg. She called EMS and was evaluated at her home. Patient was hypertensive at the time but was told she did not need to come to the ED. Afterward she took a Benadryl and went to bed. She states the benadryl just made her sleepy but did not improve her numbness. This morning she woke up still feeling numb and called her PCP. The RN she spoke to recommended she come to the ED. She is dizzy but she states this is normal per her baseline. States HTN previously resolved.
67 2021-03-01 palpitations Pt got very hot & flushed then had a sudden urge to urinate. Heart then started racing. Feeling pass... Read more
Pt got very hot & flushed then had a sudden urge to urinate. Heart then started racing. Feeling passed quickly and she relaxed and started feeling better. Stayed for about 20 minutes in pharmacy area and was feeling well when she left. I called her later that evening and she was fine
67 2021-03-01 palpitations About 10 minutes after I received the injection, I felt dizzy. Prickling sensations and flushing on ... Read more
About 10 minutes after I received the injection, I felt dizzy. Prickling sensations and flushing on the backs of my hands and on my face. Racing heartbeat. The symptoms lasted for about 5 minutes, then subsided completely. Approximately an hour later I felt very tired, and had a mild headache. Took a Tylenol tablet and rested. Felt better after about 2 hours.
67 2021-03-02 chest pain, fainting ER admit for CP and Jaw pain, exhaustion, Aortic arteritis normal SED rate found on CT scan hospital... Read more
ER admit for CP and Jaw pain, exhaustion, Aortic arteritis normal SED rate found on CT scan hospital admit IV medications required Solumedrol and Actemra questionable how much medications received d/t IV's not working. Released from care on 2/19 with prednisone . Symptoms still present off and on. 2/21 922pm CP Jaw Pain severe EMT's called EKG done reported no heart attack, pain better, EMTs left. 10/15 severe Pain collapsed with no pulse and no breathing, EMTs returned unable to obtain a shock-able rhythm time of death pronounced. reason for death on certificate Aortitis - hospitalist thinks aortic dissection d/t severe inflammation
67 2021-03-02 heart rate increased At 8am Jan 20th (30 hrs after shot) I woke feeling extremely strong and powered up, very energized a... Read more
At 8am Jan 20th (30 hrs after shot) I woke feeling extremely strong and powered up, very energized and liken the mental energy to feeling like I was on steroids. Went downstairs to kitchen to make a cup of tea and it was then I realized my pulse was going extremely fast (about 180bpm). I didn't think much of it or get nervous, but went to sit down and work at my computer, hoping it would go away, After about 20 minutes I realized it hadn't slowed down, so I went back to my bedroom to get dressed in the event I had to go to an urgent care or hospital. On the way up the stairs to my bedroom I realized I was getting a bit light-headed. After about another 10 minutes I decided to lie down and called up a "calming meditation" app to see if that could lower my heart rate. I was able to get my heart rate down to about 125 after the10 minute meditation and it returned to normal shortly thereafter. The second episode was on February 11th. This time I was woken up out of my sleep at 4:45am by an extremely rapid heartbeat. Again, about 180bpm. This time I was a bit frightened. I walked around the house for about 15 minutes and when it didn't go down I decided to go out for a walk. I did about a 30 minute walk , I had some tingling in my hands, but by the end of the walk my heart rate came down to about 100 and dropped back to normal shortly after.
67 2021-03-02 hypertension Pt had elevated BP and scratchy throat
67 2021-03-02 pallor, fainting Pt received her vaccine, during her 15 minute post vaccine observation period, pt became pale, cool ... Read more
Pt received her vaccine, during her 15 minute post vaccine observation period, pt became pale, cool to touch, & diaphoretic. Pt had 2 witnessed syncope episodes. EMS was present at clinic & transported her to the local ED (Hospital). She was admitted to the hospital on 2/25/21 & was discharged on 3/2/21.
67 2021-03-03 blood pressure increased Her blood pressure was very elevated. EMS was called and taken to the hospital. She had COVID many ... Read more
Her blood pressure was very elevated. EMS was called and taken to the hospital. She had COVID many months prior.
67 2021-03-03 loss of consciousness APPROXIMATELY 10 MINUTES AFTER RECEIVING THE VACCINE SHE STATED THAT SHE FELT DIZZY. WE ASKED HER T... Read more
APPROXIMATELY 10 MINUTES AFTER RECEIVING THE VACCINE SHE STATED THAT SHE FELT DIZZY. WE ASKED HER TO REMAIN SEATED. SHE STATED SHE FELT LIKE SHE WAS GOING FAINT AND ALSO FELT NAUSEATED AND HOT. WE GAVE HER WATER THEN SHE LOST CONCIOUSNESS FOR APPROXIMATELY 15 SECONDS. SHE REGAINED CONSIOUSNESS AND THEN BEGAN TO VOMIT. WE CALLED 911. EMS ARRIVED AND CHECKED HER VITALS AND TOOK HER TO THE HOSPITAL.
67 2021-03-04 chest pain, blood pressure increased, fast heart rate heart raced 130 bpm; right arm went numb; bitter medicine taste; lips and tongue tingling; numbness ... Read more
heart raced 130 bpm; right arm went numb; bitter medicine taste; lips and tongue tingling; numbness of the lips; numbness of the throat; dry mouth; super thirsty; elevated blood pressure of 175/56; couldn't talk; shaking; terrible pain in chest and mid area; gassiness; headache; Nausea; A spontaneous report was received from a Consumer concerning a 67 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, terrible pain in chest and mid area, nausea, right arm went numb, gassiness, and headache. The patient's medical history provided included Lupus and Sjogren's. No relevant concomitant medications were reported. On 12-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021, The patient experienced the events of bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, terrible pain in chest and mid area, nausea, right arm went numb, gassiness, and headache. Laboratory details were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events of bitter medicine taste in her mouth, lips and tongue tingling, numbness of the lips and throats, dry mouth, super thirsty, heart raced 130bpm, elevated blood pressure of 175/56, couldn't talk, shaking, nausea, right arm went numb, resolved on 12 Feb 2021. The outcome of the event headaches was resolved on 13 Feb 2021. At the time of the report the events of chest pain and gassiness were ongoing.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's medical history of Lupus and Sjogren's can be contributing factor. Further information has been requested.
67 2021-03-04 hypotension c/o: dizziness, lightheaded, felt faint History of same symptom with venipuncture BP: 67/39, 74/44, ... Read more
c/o: dizziness, lightheaded, felt faint History of same symptom with venipuncture BP: 67/39, 74/44, 66/41 P: 60 Sp02: 99% Symptomatic hypotension, patient transported to ER by EMS
67 2021-03-04 loss of consciousness Fever, sweating, blackouts 2times. Very weak and queasy for a good 20 hours. Stayed in bed with bo... Read more
Fever, sweating, blackouts 2times. Very weak and queasy for a good 20 hours. Stayed in bed with body aches and headaches . Had small meal on Wednesday evening and slept better that night. Thursday and Friday still feeling weak, but much better. Also a lump has appeared at the base of my neck (left side).
67 2021-03-06 heart rate increased Patient had fast heart rate -- 156 bpm-- she felt fine otherwise. Patient took Benadryl and felt bet... Read more
Patient had fast heart rate -- 156 bpm-- she felt fine otherwise. Patient took Benadryl and felt better later in the day.
67 2021-03-06 hypertension, blood clot 3 DAYS AFTER THE 2ND INJECTION, I DEVELOPED 2 BLOOD CLOTS AT THE BASE OF MY LUNGS - 1 ON EACH LUNG. ... Read more
3 DAYS AFTER THE 2ND INJECTION, I DEVELOPED 2 BLOOD CLOTS AT THE BASE OF MY LUNGS - 1 ON EACH LUNG. IN CONNECTION WITH THAT, I DEVELOPED SEVER PAIN IN MY LOWER RIGHT FLANK AREA THAT RADIATED TO MY SHOULDER AS WELL AS HIGH BLOOD PRESSURE. THERE IS NO HISTORY IN MY FAMILY OF ANY CLOTTING ISSUES AND I MYSELF HAD NEVER HAD SUCH A THING OCCUR. THE PAIN BECAME SO BAD IT FORCED ME TO GO TO A HOSPITAL EMERGENCY DEPT. AFTER CT SCANS CONFIRMED THE PRESENCE OF THE CLOTS, I WAS SUBSEQUENTLY ADMITTED FOR OBSERVATION ON A REGIMEN OF DRUGS, BLOOD THINNER, PAIN MED, AND A CLOT BUSTER (NOT SURE WHICH MANUFACTURER.) I AM STILL EXPERIENCING PAIN IN MY RIGHT FLANK AREA - SOMEWHAT RADIATING TO MY RIGHT SHOULDER DAY 1 POST DISCHARGE AND AM HAVING TO RELY ON OPIOID PAIN MED AS WELL AS THE CLOT BUSTING MED AND A HIGH BLOOD PRESSURE MED. TO ME, IT SEEMS THAT THIS MAY NOT BE JUST COINCIDENTAL. I WAS FEELING FINE PRIOR TO THE S 2ND DOSE OF THE MODERNA VAC AND THIS SEEMS TO ME THAT IT MIGHT BE RELATED TO THE 2 DOSE.
67 2021-03-06 palpitations Started feeling woozy and nauseous within 15 min. Spike in pulse O2 good thought it was poss. hypo... Read more
Started feeling woozy and nauseous within 15 min. Spike in pulse O2 good thought it was poss. hypoglycemic reaction Provided with Orange juice. Daughter came to drive me home. At her house started extreme tremors beyond chills lips tingling confusion and heart racing. Extreme urination . beyond fluid intake for morning. Daughter called ambulance and was taken to Jasper hospital > EMT administered nausea med IV. In ambulance had extreme left ear, neck, and jaw pain. extreme headache and uncontrolled shakes tremors esp on left hand arm. Er admit and treatment until released to daughters care. 24 hrs nausea even with meds. Severe headache and body aches as of this time-frame 3:20 PM 3/7/2021
67 2021-03-06 fast heart rate Chest cold and head cold symptoms for over 7 days, diaherra on day 7, nausea, and tachacardyia.
67 2021-03-07 blood glucose increased 03/05/2021: Arm soreness (mild), itch, slight redness. 03/06/2021: raised temperature at injection s... Read more
03/05/2021: Arm soreness (mild), itch, slight redness. 03/06/2021: raised temperature at injection site, raised "knot" at injection site, blood sugar increase to over 200, swollen lymph nodes to the armpit of inoculated arm
67 2021-03-07 body temperature decreased After the second shot the next morning I had bad chills and assumed it was fever, but when I took my... Read more
After the second shot the next morning I had bad chills and assumed it was fever, but when I took my temperature it was actually very low, dangerously low at 91.4, it took about 15 minutes to increase to 94 and the rest of the day it was 97.5
67 2021-03-07 chest discomfort Headache, Tingling in mouth, swollen lips, heaviness in the chest, throat closing, sore throat, exce... Read more
Headache, Tingling in mouth, swollen lips, heaviness in the chest, throat closing, sore throat, excessive dry mouth, trouble breathing, tired
67 2021-03-07 chest discomfort Patient developed chest tightness and throat tightness 3 minutes after receiving first dose. After ... Read more
Patient developed chest tightness and throat tightness 3 minutes after receiving first dose. After 35 minutes she developed worsening chest tightness and throat tightness, she was given 50 mg of Benadryl and taken to Hospital. She was monitored for approximately 4-1/2 to 5 hours. She was discharged in stable condition. Her daughter gave her another 50 mg of Benadryl at 9 PM.
67 2021-03-07 palpitations Pt c/o palpitations, denied CP, SOB, LOC, and trauma. Upon assessment by EMT 12 lead EKG shows LBBB.
67 2021-03-08 heart rate increased At approx 2 pm Monday, March 8, 2021 I was shopping for clothes. I was having difficulty breathing ... Read more
At approx 2 pm Monday, March 8, 2021 I was shopping for clothes. I was having difficulty breathing through my mask and asked employee if they had a mask I can have. When I took mine off to use theirs, I was surprised it wasn't my usual KN95 on me as those are more difficult to breath through. I felt labored in breathing from that point. I left the store to get home quickly. I was also experiencing rapid heart rate\great nervousness and was assuming that because I purchased a large diet coke one hr before that, that the caffeine was causing this. However, I've never experienced this event. Within 3 minutes of my home, I started experiencing what seemed to be shortness of breathe. it lasted about a minute. I considered going to ER. But went home. Shortness of breathe stopped and I looked on google how to reduce caffeine reaction. I ate handful of peanuts for protein, but had odd indigestion. Kept drinking lots of water to flush out. Was doing many deep breathing exercises. Nervousness and rapid heart rate lasted about 2 hours. I was back to normal by evening. Scary as I never experienced difficulty with a regular surgical mask. Never experienced such a severe reaction to a caffeine beverage. Never experienced that shortness of breath.
67 2021-03-08 pallor Patient almost immediately became pale, slightly nauseated, tired, dizzy, obvious hoarseness
67 2021-03-08 blood clot Blood clots in arm; Arm was sore; A spontaneous report was received from a healthcare professional c... Read more
Blood clots in arm; Arm was sore; A spontaneous report was received from a healthcare professional concerning a 67-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in arm and blood clot in her arm/thrombosis. The patient's medical history, as provided by the reporter included diabetes. Concomitant medications were not included. On 15 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031M20A) in the left arm for prophylaxis of COVID-19 infection. On 15 Feb 2021, post vaccination the patient experienced sore arm and her condition got worse. She was then taken to emergency room with blood clots in her arm. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events, sore arm and blood clot in her arm, were not known.; Reporter's Comments: This case concerns a 67-year-old, female patient, who experienced thrombosis and pain in arm. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's medical history of diabetes is a risk factor. Further information has been requested.
67 2021-03-09 chest discomfort Chest tightness half hour after shot , throat tightness and difficulty swallowing two hours , after ... Read more
Chest tightness half hour after shot , throat tightness and difficulty swallowing two hours , after shot itching in mouth and throat two hours after shot , I took some Ativan and lay down was ready to go to the ER win the symptoms started to get better
67 2021-03-09 chest pain Right arm soreness (to touch as well as to use my arm) Almost immediately Difficulty raising my eye... Read more
Right arm soreness (to touch as well as to use my arm) Almost immediately Difficulty raising my eyes to read something above my head (11:30PM 03/08/2021) 7:30 AM 03/09/2021 (I woke up with the following): Fever 101°F Chills (stopped sometime after 3:00 PM 03/09/2021) Weakness of limbs Muscle and bone aches and pains (for the next 20 hours) Felt like I had been hit in my chest and abdomen by a truck SEVERE headaches (on top of my normal persistent headaches NDPH) Abdominal cramps (grew severe 10:00 PM and that lasted about 2 hours) I stayed in bed all day, tried to drink plenty of fluids, slept off and on. I took Acetaminophen every 8 hours through to 8:00 AM March 10. I was too weak to prepare meals and I live alone so I ate only 8 or 10 cookies throughout the day as they were easy to grab and get back to bed. Had moderate sweating episodes throughout the day and through the night of March 9/10. Still felt sore when I woke up at 8:00 AM on March 10, 2021. Took about 2 hours for me to get myself comfortable being upright and able to dress and move about. Waited for Acetaminophen to work.
67 2021-03-09 nosebleed Modern a COVID-19 Vaccine EUA After 12- 36 hours- slight nausea, 101.5 degree F. fever, sore arm and... Read more
Modern a COVID-19 Vaccine EUA After 12- 36 hours- slight nausea, 101.5 degree F. fever, sore arm and muscles, fatigue, bone pain, blood clots in nose, sweating, headache
67 2021-03-09 palpitations, chest pain sore arm 2 days past injection. (2/26/2021 onset Extreme fatigue, muscle aches and weakness, left ... Read more
sore arm 2 days past injection. (2/26/2021 onset Extreme fatigue, muscle aches and weakness, left side headache, left side underarm pain and shoulder pain, left side breast and chest pain, papiltations, short breath. ER visit on 3/1/2021 to Kaiser Permanent Sacramento due to pain and short breath. 4 days past onset, pain left, 5 days past onset muscle aches left 7 days past onset energy slowly coming back.
67 2021-03-10 blood pressure decreased, chest discomfort Tightness in throat and upper chest. BPs 160/100, 150/104. O2 sats 96%, then 93%. Taken to ED.
67 2021-03-10 chest discomfort, heart rate increased Approx 9AM was feeling rapid heart rate, Lips were tingly, received benadryl, Shortly after was h... Read more
Approx 9AM was feeling rapid heart rate, Lips were tingly, received benadryl, Shortly after was having tightness in chest. Was than transported to hospital.
67 2021-03-10 chest discomfort, hypertension High blood pressure. Chest tightness, left arm pain Gassy feeling. Cardiac work up done at Emergency... Read more
High blood pressure. Chest tightness, left arm pain Gassy feeling. Cardiac work up done at Emergency room. Stress test and Echocardiogram done by the Cardiologist.
67 2021-03-10 chest discomfort extreme diarreah extreme weakness, I could not walk straight or without help Chest pressure and tin... Read more
extreme diarreah extreme weakness, I could not walk straight or without help Chest pressure and tingling dizziness and confusion uneven breathing chills fever feeling Rubbery legs (I walked like I was extremely drunk) I fell against a few wall until my husband helped me to the bathroom, in the tub, then back to bed. I told my husband to be ready to call 911 if I didn't start feeling better. I woke up at 6:30 feeling somewhat better.
67 2021-03-10 heart attack, heart attack ACUTE STEMI HEART ATTACK - VENTRICULAR FIBRILLATION - 99.9% BLOOD CLOT IN RIGHT CORONARY ARTERY
67 2021-03-10 palpitations woke up with racing hard heart beat, nauseous vomiting at mid night through up til 3am felt some bet... Read more
woke up with racing hard heart beat, nauseous vomiting at mid night through up til 3am felt some better. still slightly sick and tired.
67 2021-03-11 chest pain, atrial fibrillation 2/18/21 chest soreness, shortness of breath. 2/19/21 chest soreness, tired body aches, shortness o... Read more
2/18/21 chest soreness, shortness of breath. 2/19/21 chest soreness, tired body aches, shortness of breath increased slightly. Continued for 3 days. 2/23/21 seen Dr extreme shortness of breath, chest pain, body aches, headaches, extreme tiredness. Blood work, chest X-ray, ekg ordered and completed that same day. 2/25/21 seen at clinic increase in symptoms, COVID test completed. Evening of 2/25/21 went into a-fib hospitalized for 3 days.
67 2021-03-11 chest pain The evening of the shot I felt like I couldn't breathe. I waited until morning and I went to the eme... Read more
The evening of the shot I felt like I couldn't breathe. I waited until morning and I went to the emergency room. Extreme fatigue with chest pain. Doctors suspected heart attack. Oxygen level was 94%. A low grade fever and swollen. The next day after my oxygen was up I was discharged my oxygen has remained at 96-97% when it was previously 98-99%. I had valley fever in the past. I was prescribed antacids and pain Morphine and antibiotics. The doctor stated that I had inflammation of the space between my ribs. I got the second shot and the symptoms were different
67 2021-03-11 loss of consciousness Vaccine was Thur 3/11 at noon. Slight headache and pain at site of injection. Friday morning, was v... Read more
Vaccine was Thur 3/11 at noon. Slight headache and pain at site of injection. Friday morning, was very dizzy. Had walked into kitchen to get the thermometer. My temp was 99. I got very dizzy and passed out for a second or two. When I hit my head on a cabinet handle I came to. At first I though I was in my bed and couldn't figure out what I had hit my head on. There was blood coming from the wound. My husband came to help me. We stopped the bleeding after a few minutes and I began icing my head. I was still very dizzy and had an urge to use the bathroom. I was afraid to get up. With my husband's help, I crawled to bathroom and he helped my onto toilet. I had diarrhea. At that point I was able to walk with help to my bed. I have had a mild to moderate headache since I had the vaccine.
67 2021-03-12 chest discomfort Pt developed Chest pressure 20 minutes post injection, BP was 150/90 Transported to medical center v... Read more
Pt developed Chest pressure 20 minutes post injection, BP was 150/90 Transported to medical center via Amb CAOx3
67 2021-03-12 hypertension Severe headache ; checked blood pressure and noted 220/113.. remained chronically high and seeked o... Read more
Severe headache ; checked blood pressure and noted 220/113.. remained chronically high and seeked out medical care. Placed on metatoprol, 100 mg. Beginning to drop after 22 days.
67 2021-03-12 fainting Mild dizziness after shot. But I passed out the next day after feeling extremely dizzy & nauseous. ... Read more
Mild dizziness after shot. But I passed out the next day after feeling extremely dizzy & nauseous. Then my husband also got dizzy & nauseous the following day. I thought it might be my meds but the only thing we both take is Levothyroxine. We were dehydrated??
67 2021-03-13 heart rate increased Moderna COVID-19 Vaccine EUA I had two adverse events after my second dose: - rapid heartbeat for a... Read more
Moderna COVID-19 Vaccine EUA I had two adverse events after my second dose: - rapid heartbeat for almost 2 hours starting about 16 hours after vaccination (ceased after this amount of time) - slightly over 48 hours after vaccination, I lost my sense of taste (I ate peanut butter) - not recovered yet, will consult doctor if doesn't resolve in one week
67 2021-03-13 loss of consciousness Seizure and passed out.
67 2021-03-13 palpitations Racy heart, chills, nausea ,slight runny nose,.The racy heat happen several times which I noticed.I ... Read more
Racy heart, chills, nausea ,slight runny nose,.The racy heat happen several times which I noticed.I was very sleepy and took a short nap around 4 pm which lasted 30 minutes. I got up to start dinner.But as I was cooking I became very nauseated with stomach cramps.Yikkes .I rested again drank a glass of water and continued making dinner .I had bone broth ,myself for dinner.
67 2021-03-14 atrial fibrillation, heart rate irregular, heart rate increased Awoke in the night following the 2nd dose of the vaccine, with an irregular heart rhythm and elevate... Read more
Awoke in the night following the 2nd dose of the vaccine, with an irregular heart rhythm and elevated heart rate. I contacted the Hospital and was told to come in for an ER eval. --I did go to the ER and was treated for Rapid Atrial Fibrillation. My heart rate was approx. 130 and B/P was approx. 158/100 --both are very elevated for me. (my resting heart rate avg is 50-55 and B/P is avg 124/80) Was given Cardizem IV push and then tablet of Cardizem while in the ER. Then later on same day saw my Cardiologist, who confirmed I was still in Afib.
67 2021-03-14 blood glucose increased, loss of consciousness Patient said she passed out 3 times the next day, has felt dizzy all week, and her blood sugar has b... Read more
Patient said she passed out 3 times the next day, has felt dizzy all week, and her blood sugar has been elevated.
67 2021-03-14 excessive bleeding PATIENT HAD SEVERE SWELLING RIGHT AFTER INJECTION. BLEEDING AS WELL
67 2021-03-14 heart rate decreased, heart rate increased, fast heart rate Heart rate increased to 150 BPM in middle o night. Woke me up. Took 1 propanolol ,20 mg. HR decreas... Read more
Heart rate increased to 150 BPM in middle o night. Woke me up. Took 1 propanolol ,20 mg. HR decreased WNL within 45 minutes Had flu like symptoms for next 3 days. Vomited in middle of night, 2 nights later.
67 2021-03-15 chest pain Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of ... Read more
Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis.
67 2021-03-15 palpitations, cardiac arrhythmia, ventricular tachycardia Dizziness, Arthralgia & Palpitations The problems began with frequent PVCs which were recorded with ... Read more
Dizziness, Arthralgia & Palpitations The problems began with frequent PVCs which were recorded with the patient's loop recorder (has for paroxysmal atrial fibrillation and has occasional PVCs) but these worsened then on 2/14/2021 developed 20 second run of slow VT at the rate of 160 bpm. Palpitations subsided and then February 18 began having arthralgias of bilateral hips and knees. This eased and then on February 20 had sudden severe pains in the right knee which continued to progress until both bursae were bulging and patient could bare walk with toe touch only the right due to the pain. This persisted until March 8 when the patient developed fever of 101 with chills. Went to ER on March 9 where noted to have increased WBCs with Neutrophil shift. Knee improved after IV Tylenol and Rocephin - still tightened quadricep tendon with occasional pain.
67 2021-03-15 fainting Chills, body aches, fainting and falling
67 2021-03-16 heart rate irregular, blood pressure increased, chest discomfort 1-2 days of slight soreness and swelling at injection site. However, exactly 14 days later, tight c... Read more
1-2 days of slight soreness and swelling at injection site. However, exactly 14 days later, tight chest, front and back ribs, spine and all back muscles hurt with unusual severe pain. Loss of appetite and "tingling" as well as elevated blood pressure and "wierd" feeling irregular heart rhythm. This lasted exactly 5 days. 6th day, fortunately the other symptoms seemed much better, but now occasionally there is a "tingling" sensation throughout my entire nervous system... in other words I feel it in my chest, arms, legs. There has been no dizziness associated with any of these symptoms. Had I felt any difficulty breathing I would have immediately gone to the hospital or emergency room, but that never occured. I told my husband, I felt (based on what you hear) like the symptoms were "covid" but no fever, no nausea and no lung issues... just really strange pain. Today, 17th of March, I am feeling better (I have also been off work), but I am concerned as I am scheduled in less than 10 days for a second moderna vaccine, and I am uncertain what to do.
67 2021-03-16 hypotension, loss of consciousness Exactly 2 weeks after receiving the 2nd moderna dose , i donated a pint of blood on march 10, 2021. ... Read more
Exactly 2 weeks after receiving the 2nd moderna dose , i donated a pint of blood on march 10, 2021. I have given many times in the past. I had consulted with the blood bank to see if i could donate blood on 3/10/21 two weeks following my 2nd moderna dose I passed out twice following the donation &,they were quite concerned due very low BP. When i got home late afternoon, i did not feel well with nausea, fatique & headache. The symptoms resolved by the following morning
67 2021-03-16 hypotension had 2nd vaccine March 12, 2021, then next day significant fatigue, March 14 nausea, diarrhea, aches,... Read more
had 2nd vaccine March 12, 2021, then next day significant fatigue, March 14 nausea, diarrhea, aches, feverishness, March 15lightheaded and hypotensive to bp 76 systolic
67 2021-03-16 loss of consciousness, hypotension, fast heart rate Patient exhibited a forceful cough for a few minutes after receiving vaccine. RN talked with patien... Read more
Patient exhibited a forceful cough for a few minutes after receiving vaccine. RN talked with patient through care giver as patient does not speak English, as well as an on site interpreter. Patient described feeling "dizzy" and "sleepy" . patient's care giver described the patients' history of absent seizures brought on by panic attacks. In this anxious state, patient was tachycardia, hypotensive, and tachypneic. RN monitored patient as she lost consciousness for about 7 minutes. in this state, patient was unresponsive with normalized heart rate and respiratory rate. Blood pressure was measured when patient was out of consciousness and was hypotensive. Patient began to regain consciousness after about 7 minutes and was oriented to person, but not place or time. Care giver insisted on not calling for an ambulance and he would take her home. Patient was given 16 ounces of water and vitals monitored for about 20 more minutes until patient was normotensive and orientedx3 and was discharged to home with care giver.
67 2021-03-17 blood pressure decreased Wheezing, face rash, blood pressure dropped.
67 2021-03-17 blood pressure decreased Wheezing, Drop in blood pressure, face rash, trembling, fever, nausea, diarrhea, insomnia, restlessn... Read more
Wheezing, Drop in blood pressure, face rash, trembling, fever, nausea, diarrhea, insomnia, restlessness, ringing in the ear, fatigue. Wheezing, rash and drop in blood pressure lasted three days.Fever, lasted two days, as well as restlessness and insomnia.Fatigue still a problem as well as nausea.
67 2021-03-17 hypertension, heart rate increased numbness in Left arm from injection site down, elevated Blood Pressure and heart rate.
67 2021-03-17 palpitations On the 14th I woke up with an upset stomach and fever of 99.5. Aches and pains all over with a sever... Read more
On the 14th I woke up with an upset stomach and fever of 99.5. Aches and pains all over with a sever headache. On the 18th I again woke up with all over aches and pains, shortness of breath, and heart palpations. Symptoms started to subside after 4 hours and taking an asprin.
67 2021-03-17 palpitations Swollen, painful nodes on collarbone area, neck stiffness and soreness. Unusual palpitations, almos... Read more
Swollen, painful nodes on collarbone area, neck stiffness and soreness. Unusual palpitations, almost a "jolt-like" feeling since day of injection, persistent throughout the day and night not related to any specific activity. Severe headache day following injection, and milder headaches throughout the week.
67 2021-03-18 cerebrovascular accident, fast heart rate Systemic: amxious and rerestlessness-Medium, Systemic: Stroke-Medium, Systemic: Tachycardia-Medium, ... Read more
Systemic: amxious and rerestlessness-Medium, Systemic: Stroke-Medium, Systemic: Tachycardia-Medium, Systemic: Unable to Sleep-Medium, Additional Details: patient has autoimmune disease.
67 2021-03-18 heart rate increased 4hrs later entire body became itchy, HR increased to 118 when she noticed the hives-she thinks it co... Read more
4hrs later entire body became itchy, HR increased to 118 when she noticed the hives-she thinks it could be r/t the anxiety; hives were noted on her back, on her stomach; all resolved within 3 hrs. Lt arm site of injection was slightly sore. Did not take any OTC medication or take any actions....self limiting
67 2021-03-18 pulmonary embolism Pulmonary embolism now on anticoagulants
67 2021-03-19 oxygen saturation decreased Chills, fever, headache, nausea, diarrhea x1, muscle aches and joint pain x24 hrs. Fever x24 hrs. To... Read more
Chills, fever, headache, nausea, diarrhea x1, muscle aches and joint pain x24 hrs. Fever x24 hrs. Took Tylenol and ibuprofen for fever, pain and headache x24hrs. Oxygen levels went down to 90-91%. Now up to 93-94%.
67 2021-03-19 palpitations, fainting Vomiting (many times..couldnt even keep a sip of water down), extreme sweating, fainting (twice), se... Read more
Vomiting (many times..couldnt even keep a sip of water down), extreme sweating, fainting (twice), severe diarrhea (several times), dizziness, chills, even with 3 long sleeve shirts, t-shirt, bra, winter coat, 3 blankets, pants socks, etc. headache, fever, heart racing a little, couldn't stand up (husband had to help me)....12 hours.
67 2021-03-19 fainting, loss of consciousness I got up around 8:30 , went to the toilet, and as I was washing my hands, I blacked out. I slipped ... Read more
I got up around 8:30 , went to the toilet, and as I was washing my hands, I blacked out. I slipped to the floor and then vomited several times. Fortunately, I had not eaten since about 7 pm the night before, but I still expelled material. Stayed in bed all day. Drank lots of water and slept. FEEL MUCH BETTER today....eating and vertical. PS After the first shot, I slept most of the next day, felt very achy, sweated, and had a headache. Those symptoms disappeared after about 24 hrs. BUT about a week after the first shot, I developed a large rash not on, but rather near the injection site. It was itchy for a day or two, as well. As I said, I feel much better today, but just thought you should know, especially because the fainting and vomiting are not listed as common reactions. THANKS
67 2021-03-21 chest pain CHEST PAIN SHORTNESS OF BREATH COVID-19
67 2021-03-21 loss of consciousness I was walking out of my apartment building to my car inside the garage on Friday at 6:00 pm. As I wa... Read more
I was walking out of my apartment building to my car inside the garage on Friday at 6:00 pm. As I was walking, my arms & legs began to feel heavy. By the time I reached the garage I was feeling extremely fatigued. I got inside of my car and thought to myself that I've never felt this tired in all of my life. I then felt very cold and decided it was best to go back upstairs. When I into my apartment unit - my cats greeted me as if I was gone for an extremely long time - and I noticed the sun coming in through my windows when the sun should have been on the other side of the building at 6:00 pm. Both the cats & the sunshine told me something was very wrong. I looked at the clock - it said 8:08. I put on the tv and discovered it was 8:08 A.M. on Saturday morning. I had fallen asleep (or passed out) in my car from 6pm Friday evening until 8am Saturday morning. I have no sleeping disorders & do not require naps during the day. Today I still feel fatigued, but only slightly. From the time I entered my car at 6pm Friday - until the time I exited my car at 8am Saturday - it felt as though only moments had passed. I had no idea I had fallen asleep or passed out.
67 2021-03-22 blood pressure increased, chest pain, fainting Under eyes feels like hives; No appetite; Left arm is stiff; Knees, legs and back all hurt; Having s... Read more
Under eyes feels like hives; No appetite; Left arm is stiff; Knees, legs and back all hurt; Having some chest pain; Left arm is swollen; Cheeks are puffy; Chills; Head hurts so bad can barley lift it off the pillow; Fainted after vaccine; High blood pressure; A spontaneous report was received from a consumer concerning a 67-year old female patient, who experienced fainting after vaccine (syncope), high blood pressure, head hurts so bad and can barley lift it off the pillow (headache), left arm is swollen (peripheral swelling), cheeks are puffy (swelling face), under eyes feel like hives (urticaria), left arm is stiff (limb discomfort), knees, legs and back hurt (pain), chills, no appetite(decreased appetite), and having some chest pain (chest pain). The patient's medical history included breast cancer, seasonal allergies, and asthma. Products known to have been used by the patient, within two weeks prior to the events, included chemotherapy unspecified (chemo pills for breast cancer). On 09 Mar 2021, prior to the onset of the events, the patient received the first of the two of their planned doses of mRNA-1273 (Lot number: 027A21A) for prophylaxis of COVID-19 infection. On 09 Mar 2021, the patient passed out at the facility right after her shot. The patient also reported that her blood pressure was very high, and she was rushed to the hospital for a few hours where vitals got down to stable, and she was sent home. On 10 Mar 2021, the patient reported that her head hurt so bad and she could barely lift her head off the pillow, her left arm is very swollen, her cheeks are puffy, under her eyes feels like hives, left arm is stiff, knees, legs and back all hurt. The patient also stated having chills, some chest pain,and no appetite. Treatment information for the events was unknown. Action taken with mRNA-1273 in response to the events was not provided. The events, fainting after vaccine (syncope) and high blood pressure were considered as recovered on 09 Mar 2021. The outcomes for the events of head hurts so bad and can barley lift it off the pillow (headache), left arm is swollen (peripheral swelling), cheeks are puffy (swelling face), under eyes feel like hives (urticaria), left arm is stiff (limb discomfort), knees, legs and back hurt (pain), chills, no appetite (decreased appetite), and having some chest pain (chest pain) were considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
67 2021-03-22 blood pressure increased, heart rate increased vertigo, high bp, high pulse, confusion,
67 2021-03-23 blood pressure increased 30 min after receiving the vaccine patient developed swollen lips and slightly swollen throat. No d... Read more
30 min after receiving the vaccine patient developed swollen lips and slightly swollen throat. No difficulty swallowing or breathing. Blood pressure was high, 02 sat 99%, no difficulty breathing or abdominal pain. She was given 50mg IV diphenhydramine and 125mg Solumedrol. She was monitored and symptoms improved within 10 min. she was monitored for 30 minutes and symptoms resolved.
67 2021-03-23 heart flutter Fluttering of the heart; Gassy; A spontaneous report was received from a consumer concerning a 67-ye... Read more
Fluttering of the heart; Gassy; A spontaneous report was received from a consumer concerning a 67-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fluttering of the heart/cardiac flutter, and gassy/flatulence. The patient's current condition included mitral prolapse. Concomitant medications included olmesartan medoxomil and carvedilol. On 5 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) in the right arm for prophylaxis of COVID-19 infection. The patient experienced the events fluttering of the heart, gassy on the evening of 05 Feb 2021 and the next day 06 Feb 2021 as well. Treatment details included gas medication, bananas and electrolytes. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, fluttering of the heart, gassy was unknown.; Reporter's Comments: Very limited information regarding rest of the events has been provided at this time. Further information has been requested.
67 2021-03-23 chest pain Pneumonia in right lung; Shooting pains in her chest; Cold; Sweats; Felt unwell; Fever up to 102.4 F... Read more
Pneumonia in right lung; Shooting pains in her chest; Cold; Sweats; Felt unwell; Fever up to 102.4 F; Shakes; A spontaneous report was received from a pharmacist for a 67 year old female patient who experienced pneumonia in right lung (pneumonia), shakes (tremors), felt unwell (malaise), cold (nasopharyngitis), fever up to 102.4 degrees Fahrenheit (pyrexia), sweating(hyperhidrosis), and shooting pains in chest (pain). The patient's medical history was not provided. No concomitant product use was reported. On 08 Mar 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 048A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 08-Mar-2021, an hour after the administration of vaccine, the patient felt unwell, was cold, had fever up to 102.4 degrees Fahrenheit, sweats, and shooting pains in chest. On 10-Mar-2021, the patient went to emergency room and was diagnosed with pneumonia in the right lung. The symptoms were persisting at the time of the report. Treatment information included paracetamol and doxycycline hydrochloride. Action taken with mRNA-1273 was unknown. The outcome of the events, pneumonia in right lung (pneumonia), shakes (tremors), felt unwell (malaise), cold (nasopharyngitis), fever up to 102.4 degrees Fahrenheit (pyrexia), sweating(hyperhidrosis) and shooting pains in chest (pain) is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
67 2021-03-23 fainting, hypotension My arm was super sore after the vaccine. 12 hrs later, I had teeth chattering chills. My temperature... Read more
My arm was super sore after the vaccine. 12 hrs later, I had teeth chattering chills. My temperature was 99, felt terrible. The night of the 17th I felt dizzy and faint. My blood pressure was 70/45 and I kept passing out. My husband called 911. My BP did finally start to stabilize.
67 2021-03-23 blood clot Reported side effects of fever, chills and headache that began within 24 hours, also reports burning... Read more
Reported side effects of fever, chills and headache that began within 24 hours, also reports burning in throat. Was evaluated by a specialist after 1 week due to continued burning and pain in throat. Reports was diagnosed with edema around vocal chords. Approximately 2 weeks after vaccination developed swelling in left arm. She was seen by her physician who sent her for an ultrasound and they found a blood clot. Patient called to report these symptoms.
67 2021-03-24 heart rate increased Chills, fever, body aches, elevated high heart rate (not normal), nausea,
67 2021-03-24 troponin increased, heart rate irregular, blood pressure increased, palpitations, chest discomfort Sudden onset of feeling very hot overall. Had a concerning irregular bounding pulse with beats skip... Read more
Sudden onset of feeling very hot overall. Had a concerning irregular bounding pulse with beats skipped after 3 beats and blood pressure elevated up to 178/80. My chest had a buzzing or vibrating feeling. Felt a chest heaviness and and short of breath.
67 2021-03-25 blood glucose increased SOB, chills, nausea, bone aches-uncontrollable with pain medication, slight fever, muscle aches, EL... Read more
SOB, chills, nausea, bone aches-uncontrollable with pain medication, slight fever, muscle aches, ELEVATED BLOOD SUGARS,with no improvement over 5 days. Symptoms slowly got better over the course of 10 days. Tinnitus still ongoing.
67 2021-03-25 blood pressure increased Cellulitis; blood pressure increased; red spot just a little to the right of where the injection wen... Read more
Cellulitis; blood pressure increased; red spot just a little to the right of where the injection went in/came back bigger and redder/darker; hard lump underneath it; it was sore; also mildly itchy, at times; A spontaneous report was received from Consumer and healthcare professional concerning a 67-yeay-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced spot just a little to the right of where the injection went in/it came back bigger and redder/darker, hard lump underneath it, it was sore, also mildly itchy, at times, cellulitis and blood pressure increased. The patient's medical history was not provided. Concomitant products were not provided. On 28 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number 025A21A) by intramuscular route on left arm for prophylaxis of COVID-19 infection. Patient reported noticing a red spot just a little to the right of where the injection site. There was a hard lump underneath it, and it was sore. The area was about 3 inch across. It was also mildly itchy, at times. On follow up, she stated she developed cellulitis around the injection site and was on antibiotics to treat the infection. Patient stated, to the right of where she was injected she had a red spot the size of a quarter, sore, it was a lump, and warm. She stated that it began to fade between 2 Mar 2021 and 5 Mar 2021. Then this past weekend, 6 Mar 2021 it came back bigger and redder/darker. She went to a walk in clinic because it was bothering her. She was diagnosed with cellulitis and was told it was either an allergic reaction to the needle or something in vaccine. She stated that when she went to the clinic it wasn't quite 3 inches in diameter. Lab tests were included Vitals taken at clinic: Temperature - 99.5 degrees Fahrenheit, Blood Pressure: 203/81 - She stated that her BP is never that high, Pulse Rate: 104, Respiratory Rate: 16 and O2 sat: 98%. The event of cellulitis was considered as serious with criteria of important medical event. Treatment was antibiotics, tylenol, ice pack on injection site for her symptoms. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events spot just a little to the right of where the injection went in/it came back bigger and redder/darker, hard lump underneath it, it was sore, also mildly itchy, at times, cellulitis, and blood pressure increased was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
67 2021-03-26 chest discomfort About 6 hours after first dose, I had some tighness in my chest and was starting to have some troubl... Read more
About 6 hours after first dose, I had some tighness in my chest and was starting to have some trouble getting my chest to move to take a breath. I nebulized with colloidial silver and felt fine within 5 minutes. Slept well all night. I am concerned about 2d dose if this issue might be worse.
67 2021-03-26 blood vessels inflammation, fast heart rate 1-31-21 - ~10:00PM - "serum pain" - "severe vasculitis" Head and ear (both) pain 2-1-21 - head and ... Read more
1-31-21 - ~10:00PM - "serum pain" - "severe vasculitis" Head and ear (both) pain 2-1-21 - head and ear (both) pain continued 2-2-21 - head pain 2-3-21 and 2-4-21 - some relief not as bad 2-4-21 - 8:30PM - vasculitis head pain again very bad and sore throat 2-6-21 - head and throat pain - a little tachycardia 2-7-21 - AM - left arm painful again, head and ears bad pain, severe chills, body aches and fever (99.6-100.2) 2-8-21 - head and ear pain, fever 100.0 blisters developed and red spots (uticaria) 2-9-21 - headache pain bad - blisters developed and red spots (uticaria) fever 100.2 - ears red, arms, legs, back, neck - "full blown relapse of vasculitis, more than a flare up." 2-10-21 - head ache, ear ache, body aches, chills fever - 99.8 2-11-21 - fever gone - head and ears still hurt 2-12-21 - head ache still 2-13-21 - feeling a little better 2-14-21 - feeling a little better 2-15-21 - head not good 2-16-21 - head not good Additional notes from the patient: 10-2020 - husband tested positive on 10-16-2020 (sx/sy started on 10-7-2020) Patient that I am reporting for now, says she developed a vasculitis headache on 10-8-20 with head pain, ear pain, on 10-9-2020,10-10-2020,10-11-2020,10-12-2020,10-13-2020, throat, cough, severe chills - on 10-21-2020 she reported NEGATIVE for Covid-19 10-22-2020 - low fever 10-23-2020 - fever; (10-24-2020, 10-25-2020, 10-26-2020, 10-27-2020, all "usual" symptoms increased in severity as well) 10-29-2020 - tested again for COVID-19 came back NEGATIVE - both COVID-19 tests were PCR
67 2021-03-27 heart attack Pt was hospitalized from 3/19-3/21 for intractable n/v following COVID-19 vaccination and subsequent... Read more
Pt was hospitalized from 3/19-3/21 for intractable n/v following COVID-19 vaccination and subsequently had a type 2 NSTEMI. Pt states she got her vaccine on Thursday and then developed severe GERD sx that night. She states she normally does not have GERD and she tried antacids and PPI for her sx. She states she tried to sleep but awoke with projective vomiting and was unable to stop this. She also had myalgias and fatigue. She went to ER and hospital notes indicate supportive care was given and sx resolved quickly. Pt never developed any CP or SOB.
67 2021-03-27 hypertension Within 5 minutes after the injection I became extremely hot, my face turned very red and began expe... Read more
Within 5 minutes after the injection I became extremely hot, my face turned very red and began experiencing intense lower back pain. The intense lower back pain lasted about 15 minutes. Later in the day and the following day I had chills, headaches and was shaky.
67 2021-03-27 palpitations 3:25-21: Noon starting muscle aches, fatigue, nausea and confusion, very thirsty; 4 pm stronger musc... Read more
3:25-21: Noon starting muscle aches, fatigue, nausea and confusion, very thirsty; 4 pm stronger muscle aches, fatigue, stronger nausea, very thirsty and couldn't shake the confusion. 3-26-21: 1 a.m. woke with 102/103 temp. extreme full body aches, extreme fatigue, nausea, very thirsty, confusion and panic (I thought someone was trying to kill me.) heart racing. I had difficulty locating Tylenol, Advil and thermometer. Paced in confusion, began crying. Took 2 extra-strength Tylenol. 3-26-21 8 a.m. temperature 101, full body aches, nausea, extreme thirst, and confusion, paranoia gone took more extra strength Tylenol. 3 p.m. same symptoms. Took two extra-strength Advil. 10 pm same symptoms took two extra strength Tylenol. 3-27-21: 8 a.m. temperature 100, body aches were not as bed, These symptoms continued to 3-28-2021.
67 2021-03-28 pallor Hands, especially finger tips have become extremely sensitive to cold. If I cut up cold fruit or veg... Read more
Hands, especially finger tips have become extremely sensitive to cold. If I cut up cold fruit or vegetables my hands turn white. Just taking items from fridge or freezer produces the same result. I've never had severe symptoms like this before and I cook all the time and used to handle cold and frozen food with no problems.
67 2021-03-29 chest pain Day 2 fever, muscle pain, chills Day 3 woke up dripping in sweat, pajamas soaking wet, fatigue, ache... Read more
Day 2 fever, muscle pain, chills Day 3 woke up dripping in sweat, pajamas soaking wet, fatigue, aches +4 fever Day 4 all the above and intense chest pain and nausea. Called paramedics as concerned about heart attack. Heart OK, blood sugar OK, BP was 211. Day 5 fatigue, cold, aches, covid are, Day 6 started feeling batter Today, arm still itchy with rash.
67 2021-03-29 oxygen saturation decreased, loss of consciousness Post vaccine 2/9/21, I experienced drop in O2 Sat over a period of several weeks as I log my daily v... Read more
Post vaccine 2/9/21, I experienced drop in O2 Sat over a period of several weeks as I log my daily vitals (blood sugar, BP, Temp, Pulse rate and O2 Sat in percent). I have O2 concentrator that I use as needed via nasal cannula. I do have SOB with exertion due to Sarcoidosis of the Lung. I notified my PCP on 2/19 of a morning sat of 89 which came up with O2 and breathing exercises, I also took a 20mg. Lasix and Mucinex chewable which usually helps with congestion. With O2 and rest, my O2 Sat improved and extra O2 was stopped. Then again my O2 steadily dropped over a period of a week, I coughed more (always have come cough), SOB. On March 7th, getting ready for bed, I became severely SOB, O2 Sat now 82, I called 911. Was alert, oriented when Paramedics arrived, but needed 100% O2 and transported to Hospital, SOB was severe, gasping/drowning, loss of awareness, apparently resp. arrested, was intubated. STAT CT with Contrast, and Echocardiogram, R/O PE, Lung collapse, etc. (No PE/or collapse). MY supposition is that I had a slow moving allergic response to Moderna Vaccine (I am a former healthcare worker of 20 years) and currently work in healthcare medical devices in Ultrasound. I closely watch vaccine development and read research articles on Sarcoidosis, vaccines and COVID. I participated and continue with a Sarcoidosis Study). I think I experienced cytokine storm with my ultrasensitive immune system. I use oral steroid (QVAR 40mics inhaled daily) which I doubled after taking the vaccine for a few weeks. I have had a MMR vaccine last June 2020 and Quadvalent Flu vaccine last August 2020.
67 2021-03-29 palpitations Just under 5 hrs. after injection, my heart suddenly started racing rapidly and my abdomen started s... Read more
Just under 5 hrs. after injection, my heart suddenly started racing rapidly and my abdomen started swelling up. I immediately took Benedryl and after 20min. passed, my heart rate returned to normal. I have been continuing Benedryl daily ever since the event.
67 2021-03-29 lightheadedness By late afternoon my left arm and armpit felt a little sore. I went to bed around 8 p.m. and awoke... Read more
By late afternoon my left arm and armpit felt a little sore. I went to bed around 8 p.m. and awoke at 11 p.m. ~12 hours after receiving my second vaccination, with chills, arthralgias, myalgias, headache, a slightly stiff neck. I got up to take some Acetominophen and Ibuprofen. My hands shook badly and I had trouble opening the bottles and getting out a couple of pills (APAP 500 mg, Ibuprofen 400 mg). I returned to bed and eventually the symptoms subsided and I fell asleep. In the morning I had extreme lethargy, felt dizzy after standing a few minutes to the point of pre-syncope as I made it back into bed. I slept on and off most of the day (Saturday). By Sunday, I was much improved but still had little energy and took it easy. My left axilla still felt a little full but I could not detect any lymph nodes. By Monday, I was pretty much back to normal including my left arm and axilla.
67 2021-03-29 pulmonary embolism Diarrhea, Pulmonary embolism resulting in death
67 2021-03-29 fainting Vaccine given at 9:05 am - by late afternoon felt sluggish, chilled, headache, achy During the nigh... Read more
Vaccine given at 9:05 am - by late afternoon felt sluggish, chilled, headache, achy During the night, I went to the bathroom several times. Each time I felt very "sick," aches and pain all over, headache, weak, hard to walk, fever of 100 (usually run 97.4.) Last trip to the bathroom, felt very weak and tried to get back to my bed. I blacked out, fallingl in the floor. I have no idea what part of my body hit the floor first, but my entire right cheek and under my chin, right shoulder, right hand all bruised and very sore. Both knees hurt from the fall. Still experiencing facial bruising/soreness, chin area, right shoulder, right hand and knees.
67 2021-03-30 chest pain I have chest. Pain and hand joint and muscle pain on my right hand, and sometimes it feels like the ... Read more
I have chest. Pain and hand joint and muscle pain on my right hand, and sometimes it feels like the palm of my hand is under fire.
67 2021-03-31 heart rate increased PATIENT STATES APPROXIMATELY 2 HOURS AFTER RECEIVING VACCINE SHE EXPERIENCED: BODY ACHES, HEADACHE, ... Read more
PATIENT STATES APPROXIMATELY 2 HOURS AFTER RECEIVING VACCINE SHE EXPERIENCED: BODY ACHES, HEADACHE, ARM PAIN, FACE FLUSHING, LIGHT HEADEDNESS, ELEVATED HEART RATE, WEAKNESS/FATIGUE, JOINT PAIN, LOW BACK PAIN, NEUROPATHY FLARE UP. DID NOT HAVE FEVER OR VOMITING. SHE DID NOT SEEK MEDICAL TREATMENT. TOOK 1 DOSE OF HYDROCODONE AT 7 PM AND 1 DOSE OF ASPIRIN AT 9 PM. PATIENT DOES NOT WANT TO TAKE THE SECOND DOSE OF THE VACCINE SERIES.
67 2021-03-31 hypotension Pt admitted with adrenal crisis after second dose of CORONAVIRUS COVID-19 VACCINE. Received second ... Read more
Pt admitted with adrenal crisis after second dose of CORONAVIRUS COVID-19 VACCINE. Received second dose of covid-19 vaccine on 2/25/21 at approximately 230pm, reported only sore arm in the evening of the 25th but later developed fever, chills, and malaise the next morning. Patient reported falling x 2 but does not recall events of the day, was being cared for by boyfriend who had been giving her water throughout the day, patient was not eating. Patient was later found by a friend who is an anesthesiologist on 2/26/21 and brought to the ER. The patient reported difficulty ambulating and requiring assistance. She can only recall two falls and then sitting in a wheelchair in the ER. Initial vitals 02/26/21 at 1941 BP: 144/69 | Pulse: 97 | Temp: 102.3 °F (39.1 °C) | Resp: 20 | SpO2: 96 % lowest BP noted 02/26/21 2306 84/46 The patient was initially given 2.5 liter of IVF and hydrocortisone 100 mg iv, zofran. Ceftriaxone was given for possible UTI but not continued as pt did not have sx c/w UTI (urine culture was eventually negative). Hydrocortisone 100 mg iv every 8 hours continued and pt started on ivf with bicab for acidosis. Hypotension resolved. Pt was tolerating oral intake with resolved nausea and vomiting.
67 2021-03-31 low blood oxigenation, heart rate increased Chills; Low fever of 99.3F; Soreness on injection site; Oxygen levels went down to 93%; Rapid heartb... Read more
Chills; Low fever of 99.3F; Soreness on injection site; Oxygen levels went down to 93%; Rapid heartbeat; Headache; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rapid heartbeat, headache that won't go away, chills, low fever of 99.3f, soreness on injection site, oxygen levels went down to 93%. The patient's medical history reported was gastritis. Current condition include immune issues. Allergies include Omnicef. No relevant concomitant medications were reported. On 16 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 015M20A) in the right arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient experienced the event rapid heartbeat . On 16 Feb 2021, the patient experienced the event headache that won't go away . On 16 Feb 2021, the patient experienced the event chills . On 16 Feb 2021, the patient experienced the event low fever of 99.3f . On 16 Feb 2021, the patient experienced the event soreness on injection site . On 16 Feb 2021, the patient experienced the event oxygen levels went down to 93%. The event is considered as medically significant. No treatment details were provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of event, rapid heartbeat was unknown.The outcome of event, headache that won't go away was not resolved.The outcome of event, chills was unknown.The outcome of event, low fever of 99.3f was unknown.The outcome of event, soreness on injection site was unknown.The outcome of event, oxygen levels went down to 93% was unknown..; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
67 2021-03-31 pulmonary embolism Pulmonary embolism; Shortness of breath; A spontaneous report was received from a physician, concern... Read more
Pulmonary embolism; Shortness of breath; A spontaneous report was received from a physician, concerning a 67 years old female patient, who received Moderna's COVID-19 vaccine and experienced shortness of breath and pulmonary embolism. The patient's medical history was not provided. Concomitant product details were not provided by the reporter. On 15-Feb-2021, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis. On 15-Mar-2021, after the recovery from the events, the patient received her second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. On 18-Feb-2021, after first dose of vaccine, the patient experienced shortness of breath and required 2 days hospitalization for pulmonary embolism. Treatment using Enoxaparin was reported. The shortness of breath was gone once being discharged from the hospital. Rivaroxaban was prescribed as the discharge medication. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the events shortness of breath was considered resolved and of event pulmonary embolism was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
67 2021-04-01 body temperature decreased, loss of consciousness weakness; noodle legs; excruciating headache; vomit; extremely nauseous; freezing cold with chills; ... Read more
weakness; noodle legs; excruciating headache; vomit; extremely nauseous; freezing cold with chills; passed out; weak tingling feeling; loose bowels; low grade temp of 96; sore arm; total, severe exhaustion; A Spontaneous report was received from a consumer concerning herself a 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out/loss of consciousness, severe exhaustion/fatigue, sore arm/ pain in extremity, extremely nauseous, weak tingling feeling/Paresthesia , vomiting, freezing cold with chills, loose bowels/diarrhea, low grade temp of 96/body temperature decreased, excruciating headache, weakness/asthenia, noodle legs/muscular weakness. The patient's medical history was not included. Concomitant medications were not listed. On 23 Feb 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:023M7) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On 23 Feb 2021, She felt total, severe exhaustion until Saturday 27 Feb 2021. She woke up with a sore arm on 24 Feb 2021. On Sunday 28 Feb 2021, she felt extremely nauseous. She had a weak tingling feeling; she started seeing spots and passed out. When she came to, she started to vomit, was freezing cold with chills, then had loose bowels. She had a low-grade temp of 96. She had excruciating headaches. She had weakness; she has noodle legs The event passed out/loss of consciousness was medically significant and serious. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, severe exhaustion was resolved on 27 Feb 2021, and outcome of event passed out resolved on unknown date. The outcome of the events sore arm, extremely nauseous, weak tingling feeling, vomiting, freezing cold with chills, loose bowels, low grade temp of 96, excruciating headache, weakness, noodle legs were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: MOD-2021-035997:Same Reporter, Different Patient
67 2021-04-02 haemoglobin decreased Acute pancreatitis - epigastric pain, elevated lipase. Patient also has gallstones noted in gallblad... Read more
Acute pancreatitis - epigastric pain, elevated lipase. Patient also has gallstones noted in gallbladder but without biliary dilatation or elevation in bilirubin or alk phos to suggest CBD obstruction. Gallstone pancreatitis seems most likely, but cannot exclude a vaccine related event especially with onset of symptoms the day after vaccination. Patient was admitted to hospital and noted complete resolution of pain with supportive measures within the first 24 hours.
67 2021-04-02 hypotension, heart rate increased, fainting Faint; Had vertigo; decreased blood pressure; increased heart rate; A Spontaneous report was receive... Read more
Faint; Had vertigo; decreased blood pressure; increased heart rate; A Spontaneous report was received from a consumer concerning, a 67 years-old, female patient, who received Moderna COVID-19 vaccine (m-RNA-1273) and experienced vertigo and fainted/syncope. The patient medical history was not provided. No relevant concomitant medications are provided. On 11 Feb 2021, approximately 15 days prior to the onset of the events the patient received their first dose of mRNA1273(lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 25 Feb 2021,the patient experienced the events of vertigo, fainted, heart rate increased, and low blood pressure. The patient reported that she took blood pressure medicine and was normal now. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, faint, and vertigo, were unknown.; Reporter's Comments: This case concerns a 67-year-old female who experienced a serious unexpected event of syncope along with nonserious events of unexpected vertigo, decreased blood pressure and increased heart rate. Event onset occurred 15 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
67 2021-04-03 chest pain On day 4 from day of the vaccine, I woke up with a headache. I soon became extremely nauseated, run... Read more
On day 4 from day of the vaccine, I woke up with a headache. I soon became extremely nauseated, runny nose, diarrhea, frequent urination, dry heaves. Some of this was expected, but actually none of this was said to be a side affect. None of this was advertised. I had heard that the vaccine makes you sick (thru the grapevine). Didn't think it would be as bad as it was and that the Pfizer vaccine was not as reactive. I live alone and am 67 years old . My chest began to hurt. After 4 hours of being sick I called 911.
67 2021-04-04 chest pain, low blood oxigenation Patient is a 67 yo F with PMH of HTN, HLD, depression/anxiety who presents with subjective fever & c... Read more
Patient is a 67 yo F with PMH of HTN, HLD, depression/anxiety who presents with subjective fever & chills, bifrontal non-radiating HA, myalgias, non-productive cough, diarrhea since 2nd covid vaccine (03/26/21) x 4 days. Patient also endorsing SOB, chest pain only when coughing. No sudden vision changes, focal extremity weakness/numbness, syncope, palpitations, N/V, abd pain. No known prior DVT/PE, recent long distance travel/immobilization/hospitalization. +covid exposure (patient has had 23 family members die of covid). Patient endorses active suicidal ideation. Patient tested positive for covid after two doses of vaccine. Upon arrival to the hospital, patient was febrile to 38.1, hemodynamically stable, but hypoxic and placed on supplemental O2. Patient continued to require oxygen throughout hospitalization, administered remdesivir, anticoagulation and steroids. Patient discharge planning occurring. Patient will require oxygen upon discharge. 02 sat on room air at rest is 88%. Psych following patient.
67 2021-04-04 dilation of blood vessels red rash diarrhea ,vomiting,fever.chills head heach pain. chills vain in forehead poped out ;
67 2021-04-05 deep vein blood clot Sore arm then rotator cuff injury & DVT
67 2021-04-05 loss of consciousness, heart attack Pt received #2 moderna vaccine. Pt had no problems with #1 other that fatigue for 1 day. Went to sto... Read more
Pt received #2 moderna vaccine. Pt had no problems with #1 other that fatigue for 1 day. Went to store and passed out in the parking lot after passing out and hit her head on the pavement. Pt was transported to hospital. Pt was transferred to different hospital. Pt died at Hospital ER. 3 weeks ago pt diagnosed with heart murmur. Echo showed aortic valve function at 65%. Dr states he will just watch pt. no meds given. Pt family stated pt has a heart attack while at store.
67 2021-04-05 heart attack Approxinately 14+ hours after 2nd dose on 03/30/2021 patient found unresponsive and brought to ER. D... Read more
Approxinately 14+ hours after 2nd dose on 03/30/2021 patient found unresponsive and brought to ER. DX with MI and Heart Block
67 2021-04-05 fast heart rate Shaking chills, extreme fatigue, headache, neck pain, photo sensitivity, injection site pain, nausea... Read more
Shaking chills, extreme fatigue, headache, neck pain, photo sensitivity, injection site pain, nausea, fever 101.2 to 103.5F, tachycardia at 120 bpm and dizziness. Worst of all is the moderate to severe pain concentrated in my quadriceps and hips/back pain. I also have generalized muscle aches. I had polio as a child and the leg pain felt very much like a triggered post polio event, only worse than in the past. All of these symptoms are still ongoing except for the shaking chills. It?s now 32 hours post -dose.
67 2021-04-05 troponin increased, heart attack, lightheadedness 4/5/21 triage: Pt was in ED with son who was a pt today. Pt walked outside where she became light he... Read more
4/5/21 triage: Pt was in ED with son who was a pt today. Pt walked outside where she became light headed & briefly loss consciousness. This nurse witnessed pt knees begin to buckle & son lowered her to ground. Pt states "sometimes I get light headed if I haven't had enough water". Pt alert/oriented @ this time. C/o upper back pain that she states is new for her. orthostatic positive HPI: 67 y.o. female who presents with a near syncopal episode just PTA. She feels that she is dehydrated. No chest pain. Some cough, no dyspnea or fever. No hx of CAD. elevated troponin 1.28; 2.27 transferred to other HCF hpi: History of Present Illness: The patient is a 67 y.o. female with a past medical history notable for diabetes mellitus, hypertension, glaucoma who presents with chief complaint of "short of breath." Patient lives at home.Patient code status is: Full code status. Patient reports she has been battling a head cold over the past 2 weeks. Patient has had low-grade fever of 99° F. Otherwise, patient has done well. Patient had brought her son to the hospital emergency department. When patient was getting ready to leave his room in the emergency department she says she felt sudden shortness of breath and dizziness. Patient reported that she said ?I do not think I can make it.? Patient then proceeded to get weak and syncopized. Patient's son was already at her side and laid her on the ground. Patient never hit her head. When patient had return of consciousness, she continued to feel short of breath and dizzy. Patient reported that sometimes she feels a sensation at home when she is dehydrated and has not drink in enough fluids. Patient denies having any chest pain, fever, nausea, or vomiting. Patient presented to the ED with the following vital signs: Temperature 97.5°, heart rate 88, blood pressure 183/99, respiratory rate 24, oxygen saturation 85% on room air. EKG was read as normal. Laboratory findings reported as troponin I 0.11, repeat troponin I 3 hours later revealed 1.28. Other laboratory findings significant for glucose 127, BUN 30, creatinine 1.2. Chest x-ray was read as unremarkable. Patient given the following medications in the emergency department: IV fluids x2 L bolus, 324 p.o. Aspirin, nitroglycerin ointment, treatment dose Lovenox. During my evaluation of patient, patient denied having any chest pain. Patient reported that she was feeling okay. Patient was admitted to Internal Medicine service for further management of NSTEMI.
67 2021-04-06 fainting At 1 AM on 4/3/21, I got up to take some Tylenol since I woke up feeling like I had a temperature. ... Read more
At 1 AM on 4/3/21, I got up to take some Tylenol since I woke up feeling like I had a temperature. I walked to the kitchen (which isn't very far) and had an extreme feeling of overwhelming weakness and fainted. (only fainted one other time in my life). I hit my head and eye and now have bruising from my hairline and down my cheek on my right side. My eye and eye lid are black and blue. I had 101 temp and chills and body aches. Immediately starting vomiting and had diarrhea for 6 hours. Had a temp of 100 the whole day of 4/3/21. Then 99.5 on 4/4 and 4/5/21 and still tired and achy. By 4/6, I felt better. Although my symptoms were just a few days, I would have never taken the second Moderna shot, in hindsight. In fact, lots of people I know have had strong reactions to the second Moderna vaccine. I have to say I have never gotten so sick so fast in my life. No way to fight it - I felt took weak and vulnerable.
67 2021-04-06 fainting Approximately three hours after receiving the vaccine I became nauseated. I had been sitting with my... Read more
Approximately three hours after receiving the vaccine I became nauseated. I had been sitting with my legs extended, as I attempted get up from the chair I experienced a severe cramp to my left anterior leg and my knee was locked. After several minutes I was able to stand and the cramp subsided and my knee was no longer locked. As I began walking I became extremely hot and sweaty and felt light headed. I then fainted. No injury, with my husband's help and the wall I eased to the floor. After approximately 30 seconds I was able to get up and walk an additional eight feet to my bed. I still felt nauseated, hot and sweaty for 10 minutes longer. This sequence of events lasted about 15 minutes. I then felt fatigued and slept for 45 minutes. When I woke up I felt fine.
67 2021-04-07 blood glucose increased pt states she was fine for the first day after taking the vax. On 4/4/201 when she got up around 2:3... Read more
pt states she was fine for the first day after taking the vax. On 4/4/201 when she got up around 2:30 AM she was dizzy and was light headed. Her head was spinning causing her to fall. She went back to bed her but head was still spinning. She was finally able to get some sleep which helped her to feel better. Her blood sugar has been higher than usual since taking the vax. On 4/6/2021 blood sugar was normal in the morning but spiked up to 325. she was cold and felt chilled. she was getting dizzy and started throwing up. This lasted a couple of hours. On 4/7/2021 her blood sugar is still a little high but she feels better today.
67 2021-04-07 blood pressure increased Patient had waited 10 minutes after receiving vaccine. She felt hot and husband told her she had a r... Read more
Patient had waited 10 minutes after receiving vaccine. She felt hot and husband told her she had a racial rash that quickly spread to her neck and chest. Patient blood pressure became elevated and started having a headache. Patient was given Benadryl 50 mg IM
67 2021-04-07 chest discomfort, heart rate irregular Noted onset of some irregular heart beats about 4 hours after admin. Infrequent not symptomatic(hav... Read more
Noted onset of some irregular heart beats about 4 hours after admin. Infrequent not symptomatic(have had PVC's in past rarely and with fatigue/stress/caffeine combination, never treated, never diagnosed self-limiting, asymptomatic). Did yardwork and had normal evening. Awoke and noticed occasional full feeling in throat and some irregular beats (a chest thump and correlated pause in radial pulse, that decreased with a cough or valsalva maneuver. The frequency and persistence increased throughout day so that I was uncomfortable lying down to try to rest. I took an aspirin worrying about possible prolonged atrial fibrillation. At nearly 24 hours from onset, all was back to normal. No palpable irregular beats, no throat fullness, no other issues.
67 2021-04-07 deep vein blood clot, pulmonary embolism She had both doses of Moderna COVID vaccine and finished the series in mid February. She was admitte... Read more
She had both doses of Moderna COVID vaccine and finished the series in mid February. She was admitted 4/5/21 with bilateral PE and popliteal vein thrombus in the left leg. She had been sedentary the week before with a "cold" and has morbid obesity.
67 2021-04-07 hypertension Fever cough chills vomiting
67 2021-04-07 heart attack eyes hurt; Dizzy; feel like in a fog; sore throat; dizzy, balance is gone; head still hurts; most in... Read more
eyes hurt; Dizzy; feel like in a fog; sore throat; dizzy, balance is gone; head still hurts; most intense pain felt like i was having heart attack; face red; tremendous sinus congestion; head killing me, felt like 100 lbs of weight on head, about to explode; chills; Fever; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (most intense pain felt like i was having heart attack) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (most intense pain felt like i was having heart attack) (seriousness criterion medically significant), ERYTHEMA (face red), SINUS CONGESTION (tremendous sinus congestion), HEAD DISCOMFORT (head killing me, felt like 100 lbs of weight on head, about to explode), CHILLS (chills), PYREXIA (Fever) and ARTHRALGIA (joint pain). On 08-Mar-2021, the patient experienced EYE PAIN (eyes hurt), DIZZINESS (Dizzy), FEELING ABNORMAL (feel like in a fog), OROPHARYNGEAL PAIN (sore throat), BALANCE DISORDER (dizzy, balance is gone) and HEADACHE (head still hurts). At the time of the report, MYOCARDIAL INFARCTION (most intense pain felt like i was having heart attack), SINUS CONGESTION (tremendous sinus congestion), HEAD DISCOMFORT (head killing me, felt like 100 lbs of weight on head, about to explode), EYE PAIN (eyes hurt), DIZZINESS (Dizzy), FEELING ABNORMAL (feel like in a fog), OROPHARYNGEAL PAIN (sore throat), BALANCE DISORDER (dizzy, balance is gone), CHILLS (chills), PYREXIA (Fever), ARTHRALGIA (joint pain) and HEADACHE (head still hurts) outcome was unknown and ERYTHEMA (face red) had not resolved. Treatments to the event include Tylenol. This case concerns a 68-year-old female with serious unexpected events of myocardial infarction, and nonserious unexpected erythema, dizziness, balance disorder, feeling abnormal, oropharyngeal pain, eye pain, head discomfort, sinus congestion and expected fever, chills, headache, arthralgia. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-034793 (Patient Link).; Sender's Comments: This case concerns a 68-year-old female with serious unexpected events of myocardial infarction, and nonserious unexpected erythema, dizziness, balance disorder, feeling abnormal, oropharyngeal pain, eye pain, head discomfort, sinus congestion and expected fever, chills, headache, arthralgia. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
67 2021-04-08 blood pressure increased Pt felt light headed, patient takes many meds. Had not eaten since 1:00pm, was given orange juice du... Read more
Pt felt light headed, patient takes many meds. Had not eaten since 1:00pm, was given orange juice during visit, patient claimed to feel better. Patient spoke to primary care physician and put him on speaker phone, he noted blood pressure that was taken at 5:05pm which was 212/119, heart rate 80, spO2 98%. Blood pressure trended downward to 190/108, doctor felt comfortable with patient going home.
67 2021-04-08 body temperature decreased Ended up in the ER. Have been having major changes in my migraines. They are splitting across my f... Read more
Ended up in the ER. Have been having major changes in my migraines. They are splitting across my forehead. Chills and hot flashes about 30 times a day and night. My temp was so low at the hospital they were concerned. It was 94 degrees. Sleeping much more during the day than ever.
67 2021-04-08 hypotension severe muscle aches including back, headache and extremely fatigue for two and half days. eight days... Read more
severe muscle aches including back, headache and extremely fatigue for two and half days. eight days later, dizziness and extreme fatigue with low blood pressure was experienced for 1 and half.
67 2021-04-08 pulmonary embolism Diagnosed with multiple pulmonary emboli after presenting to ED with pleuritic chest pain and DOE. ... Read more
Diagnosed with multiple pulmonary emboli after presenting to ED with pleuritic chest pain and DOE. Unclear time of onset of symptoms, possibly preceding 2nd dose of vaccine by about 1 month. unclear temporal relation to initial vaccine dose.
67 2021-04-09 pulmonary embolism Pulmonary embolism; This spontaneous case was reported by a physician (subsequently medically confir... Read more
Pulmonary embolism; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization prolonged and life threatening). The patient was hospitalized on sometime in April 2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter.Treatment information was not provided. This case refers to a 67 year-old elderly female patient who developed pulmonary embolism about two weeks after receiving the second dose of mRNA-1273 vaccine. Very limited information has been provided at this time.; Sender's Comments: This case refers to a 67 year-old elderly female patient who developed pulmonary embolism about two weeks after receiving the second dose of mRNA-1273 vaccine. Very limited information has been provided at this time.
67 2021-04-11 hypertension Pt developed lightheadedness within 5 min of vaccine , HR 98, Pulse Ox 99%, T 97.3, B/P 150/98 right... Read more
Pt developed lightheadedness within 5 min of vaccine , HR 98, Pulse Ox 99%, T 97.3, B/P 150/98 right arm. 10 min past injection pt developed sensation of lip swelling and SOB Benadryl 25mg given PO. Pt transferred to ER. Of note pt did have similar reaction with hives and swelling at injection site that developed 7 days past injection with Primary Provider ordering a course of Dexamethasone that lasted for 8 days total.
67 2021-04-11 heart attack after vaccination, I sat there for 15 minutes and started to drive home, stopped to get food, drivin... Read more
after vaccination, I sat there for 15 minutes and started to drive home, stopped to get food, driving down the street I stopped somewhere and ended up sitting there for 6-8 hours according to the restaurant manager. I went to the hospital they said that I had a weird heart attack and I was dehydrated.
67 2021-04-12 blood pressure decreased Drop in blood pressure, face rash, euphoria, unstable, wheezing, tremors , diarrhea, fever, fatigue ... Read more
Drop in blood pressure, face rash, euphoria, unstable, wheezing, tremors , diarrhea, fever, fatigue , nausea, light headed.
67 2021-04-12 chest pain, hypotension, lightheadedness On 2nd day: Very bad headache, almost fainted, took Tylenol (6/day of 500mg), drank fluids, blood pr... Read more
On 2nd day: Very bad headache, almost fainted, took Tylenol (6/day of 500mg), drank fluids, blood pressure low. Better on day3, only slight headache. On 9th day: felt soreness in right calf muscle, no swelling or redness. Thought it was due to low physical activity. No stamina. Tire very easily and get sweaty upon little extertion On 10th day: felt sharp jabbing pain in chest when taking deep breath or yawning. No actual shortness of breath. On 11th day (today): decided to start taking full strength aspirin in case it is a blood clot. Took 1 in a.m. 1 in p.m.
67 2021-04-12 heart rate increased After the second vaccine I began to have trouble breathing, racing pulse when I do the slightest ac... Read more
After the second vaccine I began to have trouble breathing, racing pulse when I do the slightest activity, progressive muscle and joint pain, instability standing and walking, digestive issues, headaches and extreme fatigue. It continues to get worse instead of improving, and I am getting very concerned. I have made an appointment to see my GP the first week of May in Illinois, when I return from FL. However, if this continues I will go to the ER at the hospital.
67 2021-04-12 palpitations After the vaccine, I started feeling sluggish and tired and got a real bad headache. And I decided t... Read more
After the vaccine, I started feeling sluggish and tired and got a real bad headache. And I decided to go to bed. The headache lasted all night and part of the next day. No fever. I was tired the next day and then I was okay. About a week later, on the 17th, I noticed heart palpitations. I called my doctor to ask if I should come in. She thought I should come in if it lasted a few more days. I had the palpitations about four days and then they went away.
67 2021-04-12 fainting, loss of consciousness Patient was administered vaccine, as per protocol moved to the vaccination wait area for 15 minute o... Read more
Patient was administered vaccine, as per protocol moved to the vaccination wait area for 15 minute observation. She passed out about 5 minutes later, she came to and said she was fine, then passed out again. I called 911 when she passed out the second time, I also administered an Epi-pen injection just in case she was having an allergic reaction. Shortly after the injection she came to and by then the paramedics had arrived. They took her BP it was 130/80 they also said they see this a lot with injections and that it was syncope and that it is pretty common. We followed up with her the next day and she was fine, she feels she didn't eat that day and she a little frightened and that is why she passed out.
67 2021-04-13 deep vein blood clot, pulmonary embolism, fainting My mother and I received the Moderna vaccine on January 20th. About two weeks later on January 31st,... Read more
My mother and I received the Moderna vaccine on January 20th. About two weeks later on January 31st, she complained about her leg. It was swollen. Later on that day, she collapsed, was rushed to the hospital. Died on February 4th due to anoxic brain injury due to DVT that caused a massive pulmonary embolism.
67 2021-04-13 nosebleed nose bleeds
67 2021-04-13 heart rate increased, arrhythmia Patient suffered rapid heart beat 5 days after injection. Emergency room visit, heart was stopped a... Read more
Patient suffered rapid heart beat 5 days after injection. Emergency room visit, heart was stopped and started to get to normal heart rhythm. This event occurred after the second vaccine also.
67 2021-04-13 heart rate increased left upper arm inflammed and soreness, at site cramps on left hand tingling and generalized muscle... Read more
left upper arm inflammed and soreness, at site cramps on left hand tingling and generalized muscle aches heart rate up to 122 beats/minute overly tired No energy took Tylenol to combat low grade fever
67 2021-04-13 hypertension Chronic obstructive pulmonary disease exacerbation; Hypertension; Reaction to COVID vaccine; Really ... Read more
Chronic obstructive pulmonary disease exacerbation; Hypertension; Reaction to COVID vaccine; Really sick; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease exacerbation), HYPERTENSION (Hypertension) and VACCINATION COMPLICATION (Reaction to COVID vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product TREPROSTINIL SODIUM for Secondary pulmonary arterial hypertension. Concurrent medical conditions included Pulmonary arterial hypertension and Chronic obstructive pulmonary disease. Concomitant products included TADALAFIL for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and TREPROSTINIL SODIUM (Respiratory) at an unspecified dose four times per day. On an unknown date, TREPROSTINIL SODIUM (Respiratory) dosage was changed to 72 mcg and TREPROSTINIL SODIUM (Respiratory) dosage was changed to 60 mcg. On 25-Mar-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease exacerbation) (seriousness criterion hospitalization), HYPERTENSION (Hypertension) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (Reaction to COVID vaccine) (seriousness criterion hospitalization). On an unknown date, the patient experienced ILLNESS (Really sick), NAUSEA (Nausea) and HEADACHE (Headache). The patient was hospitalized from 25-Mar-2021 to 28-Mar-2021 due to CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERTENSION and VACCINATION COMPLICATION. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease exacerbation), HYPERTENSION (Hypertension), VACCINATION COMPLICATION (Reaction to COVID vaccine), ILLNESS (Really sick), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Description: On an unreported date, the patient had decreased treprostinil sodium breaths from 12 to 10 breaths (off label use). Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
67 2021-04-13 palpitations PATIENT SAID THAT SHE HAD MEDICAL HISTORY OF PALPITATIONS, BUT HAD BEEN YEARS SINCE. AFTER HER FIR... Read more
PATIENT SAID THAT SHE HAD MEDICAL HISTORY OF PALPITATIONS, BUT HAD BEEN YEARS SINCE. AFTER HER FIRST SHOT, SHE FELT PALPITATIONS AND WENT TO ER. ER RELEASED HER, AND SHE FOLLOWED UP WITH DR A COUPLE WEEKS LATER. SHE SAID SHE FELT PALPITATIONS FOR A WHILE AND SINCE AND DR HAS CLEARED HER FOR THE SECOND SHOT. THEY ARE NOT SURE IF IT WAS ATTRIBUTED TO THE VACCINE, BUT PHYSICIAN WANTED HER TO COMPLETE THE SERIES.
67 2021-04-13 superficial blood clot Superficial thrombosis in left calf muscle Eliquis prescribed Follow up with vascular MD Compression... Read more
Superficial thrombosis in left calf muscle Eliquis prescribed Follow up with vascular MD Compression stockings prescribed.
67 2021-04-14 blood pressure increased Pt developed shortness of breath, headache and some cramping sensation both hands post vaccination. ... Read more
Pt developed shortness of breath, headache and some cramping sensation both hands post vaccination. Bp was elevated to 170/90 mm of Hg, P : 90
67 2021-04-14 fainting 24 Hours post vaccination: full body rash for 3 days. Took Benadryl for two days it went away. Bo... Read more
24 Hours post vaccination: full body rash for 3 days. Took Benadryl for two days it went away. Both left and right hips hurt so I couldn't walk. Took Tylenol and and aspirin for two days. Pain went away. 8 Days later vomiting and diarrhea, Right and left hips hurt again. Fainted. Taking fluids, Tylenol and aspirin. Tired.
67 2021-04-14 fast heart rate, pulmonary embolism, low blood oxigenation, deep vein blood clot 4/1/21 Patient developed breathlessness, it progressed until she presented to local ER 4/13 with hyp... Read more
4/1/21 Patient developed breathlessness, it progressed until she presented to local ER 4/13 with hypoxemia, tachycardia due to Submassive pulmonary emboli, also found to have R pulmonary infarct and asymptomatic DVTs in R femoral and popliteal, L popliteal veins. Patient was admitted to hospital, treated with IV UFH, doing well. Anticipate discharge in 1-2 days. Note hospitalization data below is tentative as pt is still in hospital
67 2021-04-15 arrhythmia, palpitations Arrhythmia; palpitation; site is warm to touch; Injection site is silver dollar in size and get doub... Read more
Arrhythmia; palpitation; site is warm to touch; Injection site is silver dollar in size and get double size in the evening; Red in colour; Headache; Pain all over body; Very swollen hand; Painful rash; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Diabetes, Acid reflux (esophageal), Arthritis and Hyperlipidemia. On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (Very swollen hand), RASH (Painful rash), MYALGIA (Pain all over body) and HEADACHE (Headache). On 01-Apr-2021, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant), PALPITATIONS (palpitation), VACCINATION SITE WARMTH (site is warm to touch), VACCINATION SITE SWELLING (Injection site is silver dollar in size and get double size in the evening) and VACCINATION SITE ERYTHEMA (Red in colour). On 31-Mar-2021, HEADACHE (Headache) had resolved. On 01-Apr-2021, ARRHYTHMIA (Arrhythmia) and PALPITATIONS (palpitation) had resolved. At the time of the report, PERIPHERAL SWELLING (Very swollen hand), RASH (Painful rash), VACCINATION SITE WARMTH (site is warm to touch), VACCINATION SITE SWELLING (Injection site is silver dollar in size and get double size in the evening) and VACCINATION SITE ERYTHEMA (Red in colour) outcome was unknown and MYALGIA (Pain all over body) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
67 2021-04-15 hypertension PATIENT EXPERIENCED HYPERTENSION HEADACHE DIZZINESS DIAPHORESIS AND WAS TRANSPORTED BY EMS TO ER
67 2021-04-18 cardiac failure congestive CHF; lymphedema; did not receive 2nd Dose within 35 days; This spontaneous case was reported by a co... Read more
CHF; lymphedema; did not receive 2nd Dose within 35 days; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE CONGESTIVE (CHF) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history was reported.). On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (CHF) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced LYMPHOEDEMA (lymphedema) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive 2nd Dose within 35 days). The patient was hospitalized from 10-Mar-2021 to 07-Apr-2021 due to CARDIAC FAILURE CONGESTIVE. At the time of the report, CARDIAC FAILURE CONGESTIVE (CHF) and LYMPHOEDEMA (lymphedema) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive 2nd Dose within 35 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. This report refers to a case of INAPPROPRIATE SCHEDULE OF PRODUCT for mRNA-1273, lot # 011M20A with associated AEs of CONGESTIVE CARDIAC FAILURE and LYMPHOEDEMA. Based on the current available information and temporal association between the use of the product and the start date of the event of LYMPHOEDEMA , a causal relationship cannot be excluded. The event of CONGESTIVE CARDIAC FAILURE Was assessed as unrelated due to lack of biological plausibility.; Sender's Comments: This report refers to a case of INAPPROPRIATE SCHEDULE OF PRODUCT for mRNA-1273, lot # 011M20A with associated AEs of CONGESTIVE CARDIAC FAILURE and LYMPHOEDEMA. Based on the current available information and temporal association between the use of the product and the start date of the event of LYMPHOEDEMA , a causal relationship cannot be excluded. The event of CONGESTIVE CARDIAC FAILURE Was assessed as unrelated due to lack of biological plausibility.
67 2021-04-18 heart rate increased POST VACCINE, BECAME DIZZY, HEART RACING. BROUGHT TO OBS VIA W.C. AT 1145. WATER GIVEN, LAYING DOWN,... Read more
POST VACCINE, BECAME DIZZY, HEART RACING. BROUGHT TO OBS VIA W.C. AT 1145. WATER GIVEN, LAYING DOWN, VSS, S/S RESOLVED SOON AFTER. ESCORTED TO EXIT VIA WHEELCHAIR WITHOUT ISSUES AT 1215 WITH FAMILY MEMBER. 1145 INITIAL BP 152/91 HR 84 SATS 97% RA 1200 BP 153/96 HR 81 SATS 99% RA 1210 BP 150/102 HR 88 SATS 97% (INSTRUCTED TO MONITOR BP AT HOME WITH AUTO CUFF AND CALL PCP IF DOESNT IMPROVE PER ONSITE MD INSTRUCTIONS, ASSYMPTOMATIC; STATES ANXIETY INDUCED.
67 2021-04-18 hypertension, transient ischaemic attack Received vaccine on 03/12/2021 and on 03/18/2021 client went for a walk and her legs became like "je... Read more
Received vaccine on 03/12/2021 and on 03/18/2021 client went for a walk and her legs became like "jello". She did not think she was going to make it back to her apartment. Upon returning to her home, she had numbness in her lower extremity. She felt terrible and contacted her healthcare provider. She was seen and it was noted that she may have had a mild TIA but her blood pressure was significantly elevated and she was placed on hypertension medication. The weakness has resolved.
67 2021-04-18 hypertension Sudden tunnel vision, high blood pressure, lasting for five hours.
67 2021-04-18 hypotension, loss of consciousness Fever between 103 and 104 f, dizziness, nausea, black outs for several days. Lost consciousness full... Read more
Fever between 103 and 104 f, dizziness, nausea, black outs for several days. Lost consciousness fully 1 week after shot and was admitted to the hospital and told she was covid positive. Dangerously low blood pressure. Given steroids and fluids, and meds to prevent blood clots and sent home the next day. Continued to pass out & vomit for a few more days. Went back to ER for fluids and nausea medication. 13 days since shot, and still running fever. Still very sick.
67 2021-04-18 pulmonary embolism, fibrin d dimer increased Unprovoked pulmonary embolisms (PEs). I am uncertain why this patient developed bilateral pulmonary ... Read more
Unprovoked pulmonary embolisms (PEs). I am uncertain why this patient developed bilateral pulmonary embolisms. patient to hold on receiving her 2nd Moderna vaccine. obtain hematological consultation for input in regard to the patient receiving another Moderna vaccine, and also ask Hematology to proceed with any further evaluation and workup in regard to these unprovoked PEs, as they deem appropriate. 6 months of anticoagulation, but I would also like input from Hematology in regard to this.
67 2021-04-19 chest discomfort, hypertension Patient reported having lower back pain, high blood pressure, chest pressure, weakness, and tremblin... Read more
Patient reported having lower back pain, high blood pressure, chest pressure, weakness, and trembling 10 minutes after receiving vaccine. I checked patient's blood pressure and it was elevated at 183/103 mmHG. An ambulance was contacted for patient. She reports taking her metformin in the morning but did not take her blood pressure medication. Her son brought her enalapril to the pharmacy and she took it as well as a hydroxyzine because she did not know if her anxiety was causing it. She reports to having similar episodes in the past.
67 2021-04-20 chest pain PATIENT AWOKE WITH CHEST PAIN. Pain was anterior chest, a soreness, steady, lasted 15 min, non-radia... Read more
PATIENT AWOKE WITH CHEST PAIN. Pain was anterior chest, a soreness, steady, lasted 15 min, non-radiating, and she is unclear of alleviating or relieving factors. She states she has been unwell since a day after she had her second Moderna vaccine 4/14/21. She states that since then she has had persistent fever, TMax 101.8, fatigue, nausea, anorexia, has been unable to eat or drink.
67 2021-04-20 hypertension Chills,headache,stomache problems,arm was sore red warm,left breast pain and exhaustion. The re... Read more
Chills,headache,stomache problems,arm was sore red warm,left breast pain and exhaustion. The redness swelling itching lasted in arm for days. Injection given too low not in muscle. Went to Dr ,BP was 160/90,had headache and neck pain for 10 days straight with no relief..Never had High BP Just had stress test in December. BP continues to be higher than before vaccine.. went to neurologist for an existing problem unrelated to vaccine on Feb 9. BP 170/90, consistent with self monitoring BP at home. I spoke with about ongoing symptoms since vaccine and he suggested it could be asceptic meningitis.
67 2021-04-22 chest pain, chest discomfort At 11:05a, patient in observation area made complaint to medical monitor of trouble breathing and ch... Read more
At 11:05a, patient in observation area made complaint to medical monitor of trouble breathing and chest tightness 5 min after receiving vaccine. Patient stated she'd been feeling well prior to this. Medical monitor notified POD supervisor to call 911 and stayed with patient. At 11:10a, patient brought back to room with recliner and vital signs taken: HR 67, BP 168/98, RR 20, O2 Sats 98%. Patient continued with complaints of chest pressure with pain rating 3/10 'like someone's pushing on my chest', feeling 'very warm', and felt like 'I am having trouble catching my breath'. Cool cloth placed on forehead. Fire arrived at 11:16a to assess and take over care of patient. Patient transported to hospital.
67 2021-04-22 loss of consciousness The patient describes nausea starting the morning after the vaccine. On 4/15/21, the day after vacc... Read more
The patient describes nausea starting the morning after the vaccine. On 4/15/21, the day after vaccination, the patient was at the kitchen sink about to vomit at 11:30am. She was surprised to wake up on the kitchen floor. She does not know how long she had been passed out but knows that she went to bed at around noon. She was sitting on the edge of her bed at around 12 noon. She then woke up at about 4pm and believes she had passed out again for this period of time. The patient reports feeling nauseated for a couple of days after vaccination. The patient contacted her doctor's office to discuss the event but as of 4/23/21 she has not gotten a response from her physician's office.
67 2021-04-22 pulmonary embolism Sore arm badly aches for a few days then a week after began having shortness of breath on exertion w... Read more
Sore arm badly aches for a few days then a week after began having shortness of breath on exertion was diagnosed with Pulmonary embolism on Aril 7 2021
67 2021-04-23 hypotension, blood pressure decreased General malaise and weakness x 3 weeks, deep chills x 2-3 days, medium headache, loss of appetite, ... Read more
General malaise and weakness x 3 weeks, deep chills x 2-3 days, medium headache, loss of appetite, loss of weight, hypotension (BP dropped to 91/40 for several days), temp intermittent up to 100.8,. . Prednisone dose pack and Augmentum seemed to help last week.
67 2021-04-23 lightheadedness Extreme pain at injection site. Light headed. Almost fainted. (Had to sit on bathroom floor where... Read more
Extreme pain at injection site. Light headed. Almost fainted. (Had to sit on bathroom floor where I had gone to the toilet with head down for a few minutes before I could stand up.) Nauseous. Next morning pain at injection site was gone. No longer faint. No appetite or desire to drink. Low grade fever of 99.9. Fatigue. Ok by following morning.
67 2021-04-24 cerebrovascular accident Altered mental status, CVA vs Sepsis. Patient reports "clot was seen" put records are not forthcom... Read more
Altered mental status, CVA vs Sepsis. Patient reports "clot was seen" put records are not forthcoming at this time. Symptoms started about 2 weeks after vaccination.
67 2021-04-24 heart rate increased Patient is known to have sensitivity/allergic reactions to other medications/food/injections. She ... Read more
Patient is known to have sensitivity/allergic reactions to other medications/food/injections. She had an EpiPen on hand at the time of the injection. She is a nurse and is knowledgeable of her on health situation and medicines. She had no problem with the first Moderna vaccine she had on 4/1/2021. She sat in a chair for about 10-15 minutes after vaccination with the second dose of Moderna Covid 19. She decided to get up and walk around the store and noticed after several minutes she started having breathing problems/heart rate increased. She returned to the pharmacy and was observed for 20 minutes. She did not want us to call 911. She wanted to try to get through the reaction herself. I offered to administer her EpiPen or told her I had Benadryl injectable too. She wanted a dose of Benadryl and I gave her 50mg IM. She continued to improve and walked out of the store at her own will. Breathing and Heart rate slowed down. I have reached out to her at home and she is doing much better.
67 2021-04-25 chest discomfort sore left arm for approx. 1 week, rash at injection site for 1-2 weeks, low grade fever w/ chills f... Read more
sore left arm for approx. 1 week, rash at injection site for 1-2 weeks, low grade fever w/ chills for 12 hrs., headache at back of lower head/neck area 12-24 hrs, painful glands left side of body for 2-3 days, tight chest w/ cough for 3 days
67 2021-04-26 chest pain, pulmonary embolism My mom was very ill with fever like symptoms following her first vaccination on January 26th. The sy... Read more
My mom was very ill with fever like symptoms following her first vaccination on January 26th. The symptoms were even worse after her second vaccination March 2nd and included muscle cramping in her legs. Once she was recovered she only had a persistent cough which she attributed to allergies as the pollen count had been high. In the early morning hours of March 19th she was having difficulty breathing and chest pains. She was rushed to the emergency room where she subsequently died of cardio pulmonary embolism which the coroner indicated began within three weeks of her death.
67 2021-04-27 blood pressure increased Received the injection on January 22, Friday. Rash on Left Arm by injection site on Sunday night abo... Read more
Received the injection on January 22, Friday. Rash on Left Arm by injection site on Sunday night about 10 PM and it was gone by Monday morning. I did nothing for the rash. Blood Pressure increased at night on Sunday, Monday and Tuesday At 3:30 Am Wednesday my BP went to 214/110 so I went to the Hospital. Doctor in the hospital gave me 5 mg of Amlodipine.
67 2021-04-27 blood pressure increased Received vaccine on Friday, February 19, 2021. That night woke up at 4 am with a cold, couldn't brea... Read more
Received vaccine on Friday, February 19, 2021. That night woke up at 4 am with a cold, couldn't breath. Took nose drops and Advil. fell back to sleep and woke up 5-6 hours later and felt fine. Saturday night same thing but this time it was flu symptoms, no fever. Took Advil and woke up 5 hours later and felt fine. Sunday started to have diarrhea that lasted 2 days, blood pressure started to rise at night, and had a rash at injection site. BP did not go up as high as after the first injection and it may have been because I was still on the 5 mg of Amlodipine. After 3 days BP started to go back to normal. Rash lasted 3 days this time.
67 2021-04-27 fainting Patient collapsed and became unresponsive 24 hours after receiving second dose of vaccine.
67 2021-04-28 chest discomfort, blood pressure increased Chest Tightness, Body Aches, Diarrhea, Increased Blood Pressure, Vomiting, Weakness, Headache
67 2021-04-28 heart rate irregular, heart rate increased DIZZINESS ON THIRD DAY; ERRATIC PULSE RATE NOTICED FROM 7TH DAY THROUGH TODAY. NORMAL RESTING PULSE ... Read more
DIZZINESS ON THIRD DAY; ERRATIC PULSE RATE NOTICED FROM 7TH DAY THROUGH TODAY. NORMAL RESTING PULSE IS 65; SITTING IN BED ON 7TH DAY IT WAS 93; STANDING UP - NO ACTIVITY ON 9TH DAY WAS 106; SITTING IN DOCTOR OFFICE TODAY PULSE RATE WAS AS LOW AS 49
67 2021-04-28 pulmonary embolism I developed severe lower back/flank pain about 4 days after receiving my 2nd Moderna vaccination. T... Read more
I developed severe lower back/flank pain about 4 days after receiving my 2nd Moderna vaccination. The pain was most pronounced while lying supine and , while in that position, manifested a creeping , fluid nature, i.e. migrating from my lower back to my shoulder. I was unable to lie down comfortably. In thinking about the nature of this pain, I determined that it was possibly/probably from a PE as it seemed as if pain was migrating from my lower back to my shoulder. I'm "not a doctor but play one on TV" (LOL ) so surmised that it was something serious that decided that this was something needing attention. I presented to a hospital ER for care and was ultimately told I had 2 small PE blood clots - 1 in the base of each lung. My diagnosis was confirmed by a CT scan and I was subsequently admitted for observation. I was discharged the following day with blood thinners and blood pressure medication.
67 2021-04-29 cardiac arrest Vaccine was administered at 1215, patient was monitored for 15minutes per CDC guidelines with not ad... Read more
Vaccine was administered at 1215, patient was monitored for 15minutes per CDC guidelines with not adverse reactions noted. Approximately one hour after administration of vaccine patient noted to be moaning, fingerstick BS at 59mg/dL, Dextrose administered, pt proceeded in to cardiac arrest, CPR was initiated and EMS activated. Pt expired approximately 4 hours after incident at ER.
67 2021-04-29 haemoglobin decreased Day 0 (Day of Vaccine)--headache, muscle aches, fatigue--treated with ibuprofen. Day 1 Severe heada... Read more
Day 0 (Day of Vaccine)--headache, muscle aches, fatigue--treated with ibuprofen. Day 1 Severe headache, shaking chills, numb white hands, severe muscle aches and stiffness, fatigue--treated with ibuprofen Day 2 Mild headache and slight fatigue Day 3 Mild headache and slight fatigue Day 4 Excruciating headache, shaking chills, numb hands, drenching sweats, temp 99-100, fatigue. Treated with tylenol alternating with ibuprofen Day 5 Temperature 103 Excruciating headache, shaking chills, drenching sweats, fatigue. Visit to health center--labs showed Hgb/Hct 9/25.9 Day 6 Felt a little better but still temp 100, headache, fatigue. Follow up visit with primary care doc. Repeat CBC Day 7 Result of CBC showed hct to be 22--sent to ER and admitted to hospital. Transfused with one unit of blood. Diagnosis hemolytic anemia with cold agglutinins. Cause unknown. Discharged after three night stay with improving hemoglobin, hematocrit, and retic ct.
67 2021-04-30 blood clot Blood clot in leg; This spontaneous case was reported by a consumer and describes the occurrence of ... Read more
Blood clot in leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in leg) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 02-Apr-2021, the patient experienced THROMBOSIS (Blood clot in leg) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 02-Apr-2021 to 06-Apr-2021 due to THROMBOSIS. The patient was treated with Surgery (Angioplasty) for Thrombosis. On 06-Apr-2021, THROMBOSIS (Blood clot in leg) had resolved. Not Provided Concomitant product use was not provided by the reporter. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on current available information and the temporal association between product use and the stat date of the events a causal relationship cannot be excluded.
67 2021-05-01 oxygen saturation decreased weak, fever, throwing up, diarrhea, shortness of breath, low oxygen (79)
67 2021-05-03 blood glucose increased Vaccine administered at 1:30PM.Patient started developing symptoms at 1:50PM. patient complaint of h... Read more
Vaccine administered at 1:30PM.Patient started developing symptoms at 1:50PM. patient complaint of hot flash flush feeling and diarrhea . Notified doctor, he assessed patient. per provider advised to monitor patient for another 30 Minutes. Notified provider okay for patient to go home if symptoms persist or worsen go to nearest emergency room patient verbalized understanding and agreed
67 2021-05-03 heart attack, blood clot heart attack; Bood clot; This spontaneous case was reported by a consumer (subsequently medically co... Read more
heart attack; Bood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) and THROMBOSIS (Bood clot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant) and THROMBOSIS (Bood clot) (seriousness criterion death). The patient died on 23-Mar-2021. The reported cause of death was Heart attack and Clot blood. It is unknown if an autopsy was performed. Not Provided No concomitant medication were reported. No treatment information was provided.; Reported Cause(s) of Death: Heart attack; Clot blood
67 2021-05-04 nosebleed blood clot coming out of the mouth when coughing; Nose bleed; pain in her left arm; This spontaneous... Read more
blood clot coming out of the mouth when coughing; Nose bleed; pain in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT HAEMORRHAGE (blood clot coming out of the mouth when coughing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. K1OC) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in her left arm). On an unknown date, the patient experienced RESPIRATORY TRACT HAEMORRHAGE (blood clot coming out of the mouth when coughing) (seriousness criterion medically significant) and EPISTAXIS (Nose bleed). At the time of the report, RESPIRATORY TRACT HAEMORRHAGE (blood clot coming out of the mouth when coughing) and EPISTAXIS (Nose bleed) outcome was unknown and VACCINATION SITE PAIN (pain in her left arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: patient's address was updated (changed), adverse events updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
67 2021-05-05 chest discomfort, heart attack, blood glucose increased Patient states shortly after getting the vaccine and alone in her apt her head began to hurt and her... Read more
Patient states shortly after getting the vaccine and alone in her apt her head began to hurt and her back aching. States her chest began feeling "funny" and she tried calling her daughter. With no answer she called the ambulance and was transported to ER. She was told upon arrival she was having a heart attack and transferred to cath lab. Blockages were found and 3 stents placed to right coronary artery.
67 2021-05-05 heart rate increased, hypertension Per hospital reporting system "Within 5 mins of patient getting Vaccine patient told nurse she was ... Read more
Per hospital reporting system "Within 5 mins of patient getting Vaccine patient told nurse she was feeling numbness and tingling in her face. Nurse propped patient's feet up on chair got CTL to come to the room where the event was happening. Vitals was checked (BP was high and Pulse was high) cool rag was placed on patient's forehead and Provider came to access patient. Patient was kept for an hour with vitals being accessed and then released to go home with son."
67 2021-05-05 pulmonary embolism, fibrin d dimer increased She has developed shortness of breath, which was new and more worse then her usal sthma symtoms. She... Read more
She has developed shortness of breath, which was new and more worse then her usal sthma symtoms. She went to urgent care center, she has D dimer of 7000, She has CT scan doen for pulmonary embolism on 4/6/2021, She right side pulmonary embolism diagnosis as per CT chest.
67 2021-05-08 arrhythmia, deep vein blood clot Hospitalized on 3/31 following episode of unresponsiveness and confusion that started roughly 18hrs ... Read more
Hospitalized on 3/31 following episode of unresponsiveness and confusion that started roughly 18hrs after vaccination. Patient had similar presentation requiring hospitalization after first vaccine dose as well Initially presented to Hospital. Workup there included empiric antibiotic therapy, antiviral therapy did not result in improvement, MRI brain and lumbar punctures non-significant, required intubation early in admission for a brief period, then likely developed HAP/VAP and ARDS requiring re-intubation and was transferred to higher level of care our main campus facility from which I am reporting this. Here, rheum/neuro workup largely negative. Her course has been c/b multiple DVTs and Aflutter that has resolved. So far, workup for AMS and fevers have been extensive -- BEM, LP, MRI, thora, bronch w BAL were unremarkable. The patient has been monitored off abx without hemodynamic changes. She did not improve despite various abx administered and did not really respond to seroquel for her delirium. At one point, the husband was considering hospice because nothing had improved her clinical status. Given her rheumatologic hx and declining mental status after the vaccine, the patient was treated with methylpred 1 daily x3 and this dramatically improved her clinical course. She began to wake up and per the ICU, was AOx2-3 at one point, whereas she had not responded even to painful stimuli at one point. She still did have some hypoactive delirium. At this point, she was deemed stable enough to be transferred. Our phsyicians were following her through the admission, was not aware and speaking again until 5/5/21. Currently she is undergoing epilepsy workup and is still hospitalized.
67 2021-05-10 nosebleed Ear ache in right ear that feels like it's right behind my eardrum. Also 2 nose bleeds from right no... Read more
Ear ache in right ear that feels like it's right behind my eardrum. Also 2 nose bleeds from right nostril in the last week.
67 2021-05-11 blood clot Renal Infarct (blood clots to both kidneys)
67 2021-05-12 blood pressure increased, blood clot Before vaccine went for sonogram, no signs of blood clot Vein doctor did more advanced sonogram and ... Read more
Before vaccine went for sonogram, no signs of blood clot Vein doctor did more advanced sonogram and was negative again for clots. A few days later clots started appearing on varicose veins. First clot started inside of knee, thought it was a boil, it was a big red figure with a dark center, doctor diagnosed with superficial blood clots (about 10 days after vaccine) On the 10th when seeing doctor blood pressure shot up, had to double lisinopril. Patient reports history of smoking.
67 2021-05-12 excessive bleeding Swollen hands; Heavy periods; chopped her hair since she sweats a lot in her scalp; Body aches; Head... Read more
Swollen hands; Heavy periods; chopped her hair since she sweats a lot in her scalp; Body aches; Headache; Fatigue; Bleeding started; Cannot think straight; Hot flashes; Back hurts; Itchy in eyes; Confused; Anxiety increased; Feels depressed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (Bleeding started) and MENTAL IMPAIRMENT (Cannot think straight) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), LORAZEPAM, MELOXICAM, BLACK COHOSH [CIMICIFUGA RACEMOSA], ESTRADIOL, NORETHISTERONE ACETATE (ESTRADIOL AND NORETHINDRONE), CLOBETASOL PROPIONATE and ESTRADIOL for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced HAEMORRHAGE (Bleeding started) (seriousness criterion medically significant), MENTAL IMPAIRMENT (Cannot think straight) (seriousness criterion medically significant), HOT FLUSH (Hot flashes), BACK PAIN (Back hurts), EYE PRURITUS (Itchy in eyes), CONFUSIONAL STATE (Confused), ANXIETY (Anxiety increased), DEPRESSED MOOD (Feels depressed), HEAVY MENSTRUAL BLEEDING (Heavy periods), HYPERHIDROSIS (chopped her hair since she sweats a lot in her scalp), PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). On 06-May-2021, the patient experienced PERIPHERAL SWELLING (Swollen hands). At the time of the report, HAEMORRHAGE (Bleeding started), MENTAL IMPAIRMENT (Cannot think straight), HOT FLUSH (Hot flashes), BACK PAIN (Back hurts), EYE PRURITUS (Itchy in eyes), CONFUSIONAL STATE (Confused), ANXIETY (Anxiety increased), DEPRESSED MOOD (Feels depressed), PERIPHERAL SWELLING (Swollen hands), HEAVY MENSTRUAL BLEEDING (Heavy periods), HYPERHIDROSIS (chopped her hair since she sweats a lot in her scalp), PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. Patient stated that her OBGYN told her she is going thru menopause for which she was prescribed estrogen and she started getting a period. Treatment included Tylenol. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product. This case was linked to MOD-2021-110270 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: New concomitant drugs (Black Cohosh, Estradiol/norethindrone, Clobetasol propionate, Estradiol cream) were added, New events (Bleeding, back hurts, had period, itchy in eyes, cannot think straight, confused, body aches, heavy period, anxiety increased and feels depressed) were added and Suspect vaccine dosing details were updated.; Sender's Comments: Very limited information regarding this events has been provided at this time. The events are assessed unlikely related to product.
67 2021-05-13 platelet count decreased Significant decrease in platelet count
67 2021-05-14 heart attack This spontaneous case was reported by an other health professional (subsequently medically confirmed... Read more
This spontaneous case was reported by an other health professional (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cough since an unknown date. Concurrent medical conditions included COPD and Diabetes. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and life threatening) and BACK PAIN (Back ache). The patient was hospitalized from 07-Apr-2021 to 09-Apr-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and BACK PAIN (Back ache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDIAL INFARCTION (Heart attack) and BACK PAIN (Back ache) to be possibly related. Treatment includes 3 stents placed to right coronary artery. Blood sugar was over 500 and patient was put on insulin.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
67 2021-05-16 chest discomfort Client reports about 6 pm the night she got the vaccine she had asthma like symptoms. Wheezing, ches... Read more
Client reports about 6 pm the night she got the vaccine she had asthma like symptoms. Wheezing, chest tightness, etc. She does cough while I am on the phone today.
67 2021-05-16 palpitations, arrhythmia ROUGHLY 7-8 HOURS AFTER RECEIVING THE SECOND COVID VACCINE, PALPITATIONS AND SLIGHT SHORTNESS OF BRE... Read more
ROUGHLY 7-8 HOURS AFTER RECEIVING THE SECOND COVID VACCINE, PALPITATIONS AND SLIGHT SHORTNESS OF BREATH WAS EXPERIENCED. FELT FLUTTERING OFF AND ON. ON 3/17 WENT TO ED AND FOUND TO BE IN AFLUTTER RVR. HISTORY OF IRREGULARITY WITH MEDICAL AND SURGICAL INTERVENTIONS.
67 2021-05-17 heart rate increased I have had a prolonged illness ever since 3-4 days after my second Moderna Vaccination on April 9th.... Read more
I have had a prolonged illness ever since 3-4 days after my second Moderna Vaccination on April 9th. Fevers, chills, elevated heart rate (104-115), copious amounts of phlegm from my sinuses making it even harder to breath, coughing from deep in my lungs trying to clear the phlegm, much went in my stomach making me nauseous. Lethargy! I took some over-the-counter meds to keep the mucus levels to a point I could breath. but not many nor very often as I knew those led to elevated heart rate, and I already had that. Headaches became common, more like icepicks driven into my head. My GP thought I must have a sinus infection and started me on one type of antibiotics, then switched to Amoxicillin when that didn't work. Antibiotics did nothing. My best relief - 2 ibuprofen & a Benadryl taken sparingly so I could sleep. I coughed up lots of mucus! 1st trip to the Hospital ER on 05/10/2021 came when my temp reached over 100.4 & my heart rate was at 114. their conclusion: I was having a bad reaction to the vaccination. Take Afrin for 3 days & be glad I was vaccinated. Through multiple freeze then fever sessions starting this past week, I have started to feel somewhat better. my sinuses cleared, most of the coughing has subsided, the headaches are less frequent and intense. today, 05/18/2021, my heart rate finally dropped below 100 and my Oxygen level is now mid-90's .
67 2021-05-17 hypertension, cerebrovascular accident Dizziness, vision changes. Was hospitalized 4/20 through 4/22. She was having trouble with her visio... Read more
Dizziness, vision changes. Was hospitalized 4/20 through 4/22. She was having trouble with her vision. Diagnosed with Stroke in the occiput region, was also noted to be in atrial fibrillation. Elevated blood pressure.
67 2021-05-18 loss of consciousness mentally overwhelmed; missed her 2nd dose; headache on and off; staggering fatigue/hard to stay awak... Read more
mentally overwhelmed; missed her 2nd dose; headache on and off; staggering fatigue/hard to stay awake where her eyes always wanted to close; felt uneasy; dizzy; she did not make it and urinated on the floor; passed out on the toilet; nervous; jittery feelings; Hands started to shake; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out on the toilet) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis (Left knee). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), KETOROLAC and HYDROXYZINE for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NERVOUSNESS (nervous), FEELING JITTERY (jittery feelings) and TREMOR (Hands started to shake). On 13-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out on the toilet) (seriousness criterion medically significant), DIZZINESS (dizzy), INCONTINENCE (she did not make it and urinated on the floor), FEELING ABNORMAL (felt uneasy), HEADACHE (headache on and off) and FATIGUE (staggering fatigue/hard to stay awake where her eyes always wanted to close). On an unknown date, the patient experienced EMOTIONAL DISTRESS (mentally overwhelmed) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose). On 12-Mar-2021, TREMOR (Hands started to shake) had resolved. On 13-Mar-2021, LOSS OF CONSCIOUSNESS (passed out on the toilet) and INCONTINENCE (she did not make it and urinated on the floor) had resolved. At the time of the report, NERVOUSNESS (nervous), FEELING JITTERY (jittery feelings), DIZZINESS (dizzy), EMOTIONAL DISTRESS (mentally overwhelmed), FEELING ABNORMAL (felt uneasy), HEADACHE (headache on and off) and FATIGUE (staggering fatigue/hard to stay awake where her eyes always wanted to close) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment of these events were not reported. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
67 2021-05-18 pallor Resident received the moderna covid vaccine around 10 am. Reported by Charge nurse Resident with n... Read more
Resident received the moderna covid vaccine around 10 am. Reported by Charge nurse Resident with nausea and large emesis around 530am and was given gingerale to sip on. Resident also c/o dizziness, FBS 211. Report by STNA Resident has rash and dizziness. Resident eval. hives noted on trunk and legs,c/o itchiness, dizziness. BP 101/42, P 96, P.O 91 % RA, R 16, Lungs clear but diminished. skin pale,cool,moist. Dr. notified. O2 2L NC, Zofran and Benadryl ordered. Approx 8am BP down to 80/50and MD ordered a liter of IV fluids. Benadryl effective for itching; Pt did not need sent out to the hospital; IV fluids given for 24 hours and all VS improved/normalized.
67 2021-05-19 chest discomfort I was going in for a heart ablation on 5/20/2021, had a CT scan on 5/18/21 and a blood clot was foun... Read more
I was going in for a heart ablation on 5/20/2021, had a CT scan on 5/18/21 and a blood clot was found in my heart. I am a pharmacy Technician and they wanted me to stay on eliquis and added plavix to that to help dissolve clot. I spoke to the pharmacist as I had concerns about taking both and in speaking with him he asked if I had had my covid shot, I said I had, he asked which one and told him the moderna. He then stated his brother had the moderna and developed a blood clot in his lung two wks after. So I thought I should report this, I was very surprised that I had a clot as I faithfully take my eliquis daily and never miss a dose. We don't know how long this clot has been in my heart so there is no way of knowing for sure. But I has noticed in April 2021, a heaviness in my chest, and just assumed it was the Afib.
67 2021-05-19 loss of consciousness Caller stated his wife passed out and hit her head on the floor; hit her head on the floor and split... Read more
Caller stated his wife passed out and hit her head on the floor; hit her head on the floor and split it open; transferred to hospital due to cardiac complications; fall; His wife passed away; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of DEATH (His wife passed away), LOSS OF CONSCIOUSNESS (Caller stated his wife passed out and hit her head on the floor), SKULL FRACTURE (hit her head on the floor and split it open), CARDIAC DISORDER (transferred to hospital due to cardiac complications) and FALL (fall) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Caller stated his wife passed out and hit her head on the floor) (seriousness criteria hospitalization and medically significant), SKULL FRACTURE (hit her head on the floor and split it open) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (transferred to hospital due to cardiac complications) (seriousness criterion hospitalization) and FALL (fall) (seriousness criterion hospitalization). On 04-Apr-2021, LOSS OF CONSCIOUSNESS (Caller stated his wife passed out and hit her head on the floor), SKULL FRACTURE (hit her head on the floor and split it open), CARDIAC DISORDER (transferred to hospital due to cardiac complications) and FALL (fall) outcome was unknown. The patient died on 04-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. On 03 Apr 2021, the reporter stated approximately 45 minutes after receiving the COVID-19 vaccine, the patient passed out in the parking lot and hit her head on the floor which caused it to split open. The patient was taken to a hospital but had to be transferred to another hospital after experiencing cardiac complications. On 04 Apr 2021 at 4:00 am, the patient passed away. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
67 2021-05-20 palpitations Patient had a rash on her face, palpitations , fever lasting 2 days now
67 2021-05-22 low blood oxigenation pt was having shortness of breath and becoming hypoxic. came through ED on 5/20/21.
67 2021-05-24 anaemia, chest pain Shortness of breath increasing; lethargy; Hyperkalemia; Acute kidney injury; metabolic encephalopath... Read more
Shortness of breath increasing; lethargy; Hyperkalemia; Acute kidney injury; metabolic encephalopathy; Uremia; metabolic acidosis; protein calorie malnutrition; Hyperuricemia; Hyperphosphatemia; Hyponatremia; Anemia; Substernal chest pain aggravated; increasing abdominal girth; Abdominal Pain; Weakness; Nausea; multiorgan failure; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiorgan failure), DYSPNOEA (Shortness of breath increasing), LETHARGY (lethargy), HYPERKALAEMIA (Hyperkalemia), ACUTE KIDNEY INJURY (Acute kidney injury), METABOLIC ENCEPHALOPATHY (metabolic encephalopathy) and AZOTAEMIA (Uremia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer stage IV since March 2019, COPD since an unknown date, GERD since an unknown date, Hypertension since an unknown date, Tobacco user since an unknown date, Transaminases increased since an unknown date, Peritoneal carcinomatosis since an unknown date and Metastatic bone disease prophylaxis (Lumbar spine pelvis and proximal femurs) since an unknown date. Concurrent medical conditions included Acute renal failure (Due to Foley catheter placement) and Pneumonitis. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiorgan failure) (seriousness criteria death and medically significant), DYSPNOEA (Shortness of breath increasing) (seriousness criterion hospitalization), LETHARGY (lethargy) (seriousness criterion hospitalization), HYPERKALAEMIA (Hyperkalemia) (seriousness criterion medically significant), ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criterion medically significant), METABOLIC ENCEPHALOPATHY (metabolic encephalopathy) (seriousness criterion medically significant), AZOTAEMIA (Uremia) (seriousness criterion medically significant), METABOLIC ACIDOSIS (metabolic acidosis), MALNUTRITION (protein calorie malnutrition), HYPERURICAEMIA (Hyperuricemia), HYPERPHOSPHATAEMIA (Hyperphosphatemia), HYPONATRAEMIA (Hyponatremia), ANAEMIA (Anemia), CHEST PAIN (Substernal chest pain aggravated), WAIST CIRCUMFERENCE INCREASED (increasing abdominal girth), ABDOMINAL PAIN (Abdominal Pain), ASTHENIA (Weakness) and NAUSEA (Nausea). The patient was hospitalized on 09-Mar-2021 due to DYSPNOEA and LETHARGY. The patient died on 13-Mar-2021. The reported cause of death was Multiorgan failure. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (Shortness of breath increasing), LETHARGY (lethargy), HYPERKALAEMIA (Hyperkalemia), ACUTE KIDNEY INJURY (Acute kidney injury), METABOLIC ENCEPHALOPATHY (metabolic encephalopathy), AZOTAEMIA (Uremia), METABOLIC ACIDOSIS (metabolic acidosis), MALNUTRITION (protein calorie malnutrition), HYPERURICAEMIA (Hyperuricemia), HYPERPHOSPHATAEMIA (Hyperphosphatemia), HYPONATRAEMIA (Hyponatremia), ANAEMIA (Anemia), CHEST PAIN (Substernal chest pain aggravated), WAIST CIRCUMFERENCE INCREASED (increasing abdominal girth), ABDOMINAL PAIN (Abdominal Pain), ASTHENIA (Weakness) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Blood culture: negative (Negative) Negative. On 12-Mar-2021, Blood gases: abnormal (abnormal) Compensated mixed respiratory and Metabolic alkalosis. On 12-Mar-2021, Blood pressure measurement: 96/52 (Inconclusive) 96/52 mmHg, 100/50 (Inconclusive) 100/50 mmHg and 88/58 (Inconclusive) 88/58 mmHg. On 12-Mar-2021, Blood test: normal (normal) WBC-2.9 Normal, Hg-Normal, Platelet count-Normal. On 12-Mar-2021, Body temperature: 36.1 (Inconclusive) 36.1degrees Celsius, 35.9 (Inconclusive) 35.9 degrees Celsius and 36.2 (Inconclusive) 36.2degrees Celsius. On 12-Mar-2021, Brain natriuretic peptide: normal (normal) normal. On 12-Mar-2021, Chest X-ray: normal (normal) No acute thoracic pathology. On 12-Mar-2021, Computerised tomogram: abnormal (abnormal) revealed a right sided pleural effusion bony metastatic disease and hepatic metastatic disease, as well as small amount of ascites in the upper abdomen. On 12-Mar-2021, Echocardiogram: inconclusive (Inconclusive) Ejection fraction 60-65% and otherwise no significant findings. On 12-Mar-2021, Heart rate: 92 heart beats per minute (Inconclusive) 92, 86 heart beats per minute (Inconclusive) 86 and 90 heart beats per minute (Inconclusive) 90. On 12-Mar-2021, Oxygen saturation: 96 (Inconclusive) 96 percent, 93 (Inconclusive) 93 percent and 98 (Inconclusive) 98 percent. On 12-Mar-2021, Prothrombin time: normal (normal) normal. On 12-Mar-2021, Respiratory rate: 16 (Inconclusive) breaths per minute, 18 (Inconclusive) breaths per minute and 19 (Inconclusive) breaths per minute. On 12-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 12-Mar-2021, Troponin: normal (normal) normal. On 12-Mar-2021, Urine analysis: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiorgan failure), DYSPNOEA (Shortness of breath increasing), LETHARGY (lethargy), HYPERKALAEMIA (Hyperkalemia), METABOLIC ENCEPHALOPATHY (metabolic encephalopathy), AZOTAEMIA (Uremia), METABOLIC ACIDOSIS (metabolic acidosis), MALNUTRITION (protein calorie malnutrition), HYPERURICAEMIA (Hyperuricemia), HYPERPHOSPHATAEMIA (Hyperphosphatemia), HYPONATRAEMIA (Hyponatremia), ANAEMIA (Anemia), CHEST PAIN (Substernal chest pain aggravated), WAIST CIRCUMFERENCE INCREASED (increasing abdominal girth), ABDOMINAL PAIN (Abdominal Pain), ASTHENIA (Weakness) and NAUSEA (Nausea) to be possibly related. No further causality assessment was provided for ACUTE KIDNEY INJURY (Acute kidney injury). Concomitant medications were not provided. Treatment for the events included proton pump inhibitors, oxygen, Tylenol, and comfort care. Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Reported Cause(s) of Death: multiorgan failure
67 2021-05-29 heart attack Patient called our pharmacy and stated she had a ?heart attack? after she received her first COVID 1... Read more
Patient called our pharmacy and stated she had a ?heart attack? after she received her first COVID 19 vaccination. She stated she was otherwise healthy before the vaccination and a subsequent heart cath showed no blockages. Her cardiologist recommended to report this incident and for her receive her second COVID-19 vaccine.
67 2021-05-31 chest pain Hospitalization due to chest pain
67 2021-06-01 blood glucose increased Pt. presents to ED on 05/29/2021 stating that she received her 2nd Covid vaccine on 05/05/2021 and s... Read more
Pt. presents to ED on 05/29/2021 stating that she received her 2nd Covid vaccine on 05/05/2021 and she feels like she is having a reaction to her 2nd covid shot. Pt. reports having shooting left arm pain and left leg pain with movement. Pt. reports that her 1st Covid vaccine made her feel the same way. ED physician reports that pt. admitted to not taking basically any of her regular medications due to not having, ran out, or quit taking because she did not tolerate the side effects of her medications. Pt. presents with significant left lower leg edema, reports putting on 60 + pounds in the past 2 years, and reports she quit her HCTZ because it hurts to bad to get up and pee.
67 2021-06-01 loss of consciousness, fainting Unconscious; Fainted; head was rapidly spinning then developed severe vertigo; broke her 3 ribs on h... Read more
Unconscious; Fainted; head was rapidly spinning then developed severe vertigo; broke her 3 ribs on her left side; hurt her left leg; She thought "i was dying"; This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Unconscious) and SYNCOPE (Fainted) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to antibiotic and Environmental allergy. Concomitant products included LIRAGLUTIDE (VICTOZA) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criterion medically significant), SYNCOPE (Fainted) (seriousness criterion medically significant), VERTIGO (head was rapidly spinning then developed severe vertigo), RIB FRACTURE (broke her 3 ribs on her left side), PAIN IN EXTREMITY (hurt her left leg) and FEELING ABNORMAL (She thought "i was dying"). The patient was treated with IBUPROFEN at a dose of for the first couple of weeks; ASPIRIN [ACETYLSALICYLIC ACID] at a dose of for the first couple of weeks and PARACETAMOL (TYLENOL) at a dose of for the first couple of weeks. At the time of the report, LOSS OF CONSCIOUSNESS (Unconscious), SYNCOPE (Fainted), VERTIGO (head was rapidly spinning then developed severe vertigo), RIB FRACTURE (broke her 3 ribs on her left side), PAIN IN EXTREMITY (hurt her left leg) and FEELING ABNORMAL (She thought "i was dying") outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was unconscious on the bathroom floor but unaware of how many minutes she was unconscious. It was reported that overall her pain scale was 8. The patient did not go to the hospital, just stayed at home and laid in bed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
67 2021-06-03 haemoglobin decreased, loss of consciousness Office: 3/14/2021, complaining of or following up for Diarrhea (patient is here with diarrhea x3 tod... Read more
Office: 3/14/2021, complaining of or following up for Diarrhea (patient is here with diarrhea x3 today. she has also has hot flashes all day today.) .HPI Patient states she has a history of chronic diarrhea but states has worsened over the last 3 days stating her stools are "completely black." Pt. Complains of abdominal pain to lower quadrants. Patient denies abdominal pain at present but states when she gets ready to have a bowel movement has severe cramping. Patient has a history of bleeding ulcers. ER 3/14/21 67 y.o. female who presents with complaint of having had 2 watery diarrheal black colored stools earlier today. Patient does have a history of irritable bowel disease. She also has a history of a gastrointestinal hemorrhage from what sounds to be angiodysplasia. She denies fever chills anorexia nausea vomiting abdominal pain hematochezia or urinary tract symptoms. She further denies any other symptoms and specifically denies lightheadedness or dizziness. Patient also has a history of peptic ulcer disease. 3/23/21 Office: She presents today for follow-up on ER with black stools. Patient had concerns about hemoglobin is patient has felt much more week. Patient's continue current care and therapy. Patient continues PPI. Patient has felt more cold. Patient has had issues with her AV malformation and bleeding in the past 5/25/21 ER to Hospital Admission: The patient is a 67 y.o. female with a past medical history notable for AV malformation, iron deficiency anemia, reflux, CAD, hypertension, thyroid dysfunction. The patient presents for evaluation of worsening issues of weakness and patient having loss of consciousness at home. Patient brought in by EMS and found to have low hemoglobin. Patient has history of AV malformation and semi frequent GI bleeds which require transfusion. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.
67 2021-06-06 palpitations, palpitations After feeding my kittens, upon going back to bed my heart started racing and skipping beats for a lo... Read more
After feeding my kittens, upon going back to bed my heart started racing and skipping beats for a long time. Felt like for a whole minute, but probably less.
67 2021-06-07 excessive bleeding, fainting Patient suddenly fainted and fell, striking and lacerating the back of her head on a table leg. The... Read more
Patient suddenly fainted and fell, striking and lacerating the back of her head on a table leg. The laceration resulted in copious bleeding. After regaining consciousness, patient telephoned for help, and was transported by ambulance to Emergency Dept. After tests verifying no internal bleeding, the laceration was closed with four staples. Patient had no prior history of fainting, nor subsequent fainting. Fainting incident was sudden onset and not preceded by significant episode of faintness. During this day after vaccination, patient also suffered more typical second-dose side effects, including soreness of shoulder, rash, malaise and low-grade fever (100.2°F).
67 2021-06-08 nosebleed Nosebleeds from left nostril every morning for three weeks. On evening of 15th day, severe noseblee... Read more
Nosebleeds from left nostril every morning for three weeks. On evening of 15th day, severe nosebleed for one and a half hours. (Possibly from both nostrils, couldn't tell.) P.A. ordered blood tests on 17th day, my APTT was 34.1 sec. (Standard Range 23.1-34.3) Nosebleeds ended then, and have not happened since. Did not get my second shot of Moderna Covid Vaccine, as felt it was unsafe for me personally. Am disappointed to not be protected by getting both shots of the vaccine.
67 2021-06-09 chest discomfort, heart rate increased Rapid heartbeat, pressure in chest within three hours of vaccine administration. Sleeplessness. Pres... Read more
Rapid heartbeat, pressure in chest within three hours of vaccine administration. Sleeplessness. Prescribed Inderal for the symptoms, which lasted six weeks. I had blood drawn several times over this period, with elevated thyroid antibodies throughout. The vaccine triggered an immediate autoimmune thyroid response which lasted six weeks. Once the symptoms subsided I obtained the second vaccine with only normal side effects.
67 2021-06-13 heart rate increased Increase in pulse/heart rate (up to 117 bpm at rest), headache, severe body aches and a rash that la... Read more
Increase in pulse/heart rate (up to 117 bpm at rest), headache, severe body aches and a rash that lasted approximately a week.
67 2021-06-13 pulmonary embolism It woke me up about 2 am I had a severe headache and some shortness of breath. I checked my blood pr... Read more
It woke me up about 2 am I had a severe headache and some shortness of breath. I checked my blood pressure and it was 80/40 with pulse of 42. So I went to get something to drink and went back to bed, I thought I was dehydrated. Over the next few days I felt real tired and washed out and with more shortness of breath. They did an EKG and went to a Cardiologist and he thought my thyroid was off, he wanted to watch and change medication to see if it will help. I started to get worse and they CT Scan of my chest with my PCP and they found bilateral PE. I was hospitalized for a day and sent home with medication and right now I'm still out of work. I go back to the Dr. on the 23rd to see if they will let me go back to work.
67 2021-06-16 hypertension breaking out with hives; tongue swelling; blood pressure is very high, her blood pressure is 193/93;... Read more
breaking out with hives; tongue swelling; blood pressure is very high, her blood pressure is 193/93; esophageal ulcer; thick white mucus settling in her throat; heavy breathing; face is flushed; dupilumab 300 mg every other week for severe persistent asthma, uncomplicated; very ill; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking out with hives), SWOLLEN TONGUE (tongue swelling), HYPERTENSION (blood pressure is very high, her blood pressure is 193/93) and OESOPHAGEAL ULCER (esophageal ulcer) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product DUPILUMAB solution for injection for Asthma. The patient's past medical history, medical treatment(s), and family history were not provided. Concomitant products included PREDNISONE for an unknown indication. On 10-Aug-2020, the patient started DUPILUMAB (Subcutaneous) 600 mg once a day. On 24-Aug-2020, DUPILUMAB (unknown route) dosage was changed to 300 mg. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced URTICARIA (breaking out with hives) (seriousness criterion hospitalization), SWOLLEN TONGUE (tongue swelling) (seriousness criterion hospitalization), HYPERTENSION (blood pressure is very high, her blood pressure is 193/93) (seriousness criterion hospitalization) and ILLNESS (very ill). On an unknown date, the patient experienced OESOPHAGEAL ULCER (esophageal ulcer) (seriousness criterion medically significant), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (thick white mucus settling in her throat), DYSPNOEA (heavy breathing), FLUSHING (face is flushed) and PRODUCT USE ISSUE (dupilumab 300 mg every other week for severe persistent asthma, uncomplicated). The last dose administered for DUPILUMAB (DUPILUMAB) was sometime in April 2021. The patient was treated with FAMOTIDINE for Esophageal ulcer, at a dose of UNK dosage form. At the time of the report, URTICARIA (breaking out with hives), SWOLLEN TONGUE (tongue swelling), OESOPHAGEAL ULCER (esophageal ulcer), ILLNESS (very ill), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (thick white mucus settling in her throat), DYSPNOEA (heavy breathing) and PRODUCT USE ISSUE (dupilumab 300 mg every other week for severe persistent asthma, uncomplicated) outcome was unknown and HYPERTENSION (blood pressure is very high, her blood pressure is 193/93) and FLUSHING (face is flushed) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2020, Weight increased: 13 (Inconclusive) from 242 lbs to 255 lbs. Gained 13 pounds.. On 15-Mar-2021, Blood pressure measurement: incresed (High) results are unknown. On 07-May-2021, Blood pressure measurement: 193/93 High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that the patient experienced hives, tongue swelling and high blood pressure following covid-19 vaccine (Moderna) administration on an unspecified date in Apr-2021 and fell very ill. She was hospitalized. Treatment information included famotidine for esophageal ulcer, oxygen for heavy breathing and unknown treatment for rest of the events. It was reported that the patient experienced esophageal ulcer, thick white mucus in throat and heavy breathing on an unknown date in 2020. It was reported that the patient had stopped taking Dupilumab, three weeks prior to the vaccine administration. Company Comment : Very limited information regarding these events has been provided at this time. Further information has been requested. This report refers to a case of Product use issue (Unapproved dose administered) for mRNA-1273, lot # unknown is assessed as not applicable.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. This report refers to a case of Product use issue (Unapproved dose administered) for mRNA-1273, lot # unknown is assessed as not applicable.
67 2021-06-17 chest pain My face began to feel like it was burning, my cheeks and up to my eyes, including my eye lids were r... Read more
My face began to feel like it was burning, my cheeks and up to my eyes, including my eye lids were red and began to swell. It continued to burn for about 4 days. It looked like I had a sunburn but I have not been on the sun. At that point I went to Urgent care, they prescribed prednisone for 2 weeks. I went to a dermatologist and she also put me on prednisone for only for 1 week. Then I saw my internist and at this point I had some burning in my chest and it felt like bacon popping it was completely different. It never met my face. When I saw my internist she ordered a lot of lab panels and an ultrasound and it looked like lupus maybe. I went to the dermatologist she did 3 tests on my chest they came back negative for cancer. We do not know what it is and they took me out of all the other medications They got me on a vegan diet and no change at all. My face was feeling the same but my chest cleared up. Last time I had a flare up was two weeks ago.
67 2021-06-23 heart rate increased, blood pressure fluctuation So about a month later after the vaccine, I woke up with chills, felt very cold and my heart was bea... Read more
So about a month later after the vaccine, I woke up with chills, felt very cold and my heart was beating fast. I took my pulse and it was going up to 123. My oxygen saturation was good 96-98%. I took my temp and I had a low grade fever. I bought a BP monitor and my BP was as high as 145/88 and fluctuated throughout the day and would go back down. I went to an Urgent Care. I got an urinalysis and it was positive for UTI. I was prescribed a medication called Macrobid for the UTI and referred to a cardiologist. By the time I went to see the specialist, most of my symptoms had subside. I went to the cardiologist and did an ECHO and had to wear a monitor. Everything came back normal and all my symptoms has subsided except a little short of breath.
67 2021-06-23 hypotension, fast heart rate, blood glucose increased Pt was admitted from 4/7-4/8 for c/o bloody diarrhea and nausea for 1 week associated with fevers. H... Read more
Pt was admitted from 4/7-4/8 for c/o bloody diarrhea and nausea for 1 week associated with fevers. Her hgb remained stable and she was discharged to follow up with GI on 4/8 with diarrhea resoled. CT scan at that time showed no acute abnl and minor sigmoid diverticulosis. She returned on 6/9 with 4 days of bloody stool. she was discharged on 6/16/21 after a protracted hospital course . Patient is a 67-year-old female with a past medical history significant for wheelchair-bound status secondary to MS and multiple left lower extremity surgeries, type 2 diabetes, CHF, hypertension, hyperlipidemia, depression, GERD who presented to the emergency room on 6/9/2021 for evaluation of bright red blood per rectum x4 days. She was recently admitted in April for a day and a half for diarrhea that was bloody but symptoms resolved. In the ER she was tachycardic and hypotensive she also had lactic acidosis. She was ultimately admitted for anemia of acute blood loss, symptomatic hypotension and lower GI bleed as well as SIRS without sepsis. She was seen in consultation by Gastroenterology and ultimately underwent a colonoscopy on 6/11/2021 which revealed no source for the bleeding and there was no evidence of malignancy she did have diverticulosis seen. She had red-tinged stool throughout the ascending transverse descending and sigmoid colon as well as red bloody stool in the rectum. She was on no blood thinners prior to arrival it stated in her med rec that she was on aspirin but she was not taking aspirin. She remained in the hospital for close monitoring she did receive 2 units of blood. We were hoping to advance her diet and plan discharge home but unfortunately patient began bleeding again and underwent a second colonoscopy on 6/14/2021 which again revealed the same bloody stool in the transverse, descending, sigmoid and rectum. Patient did have a tagged bleeding scan which revealed evidence of bleeding with the tracer becoming visible in the region of the splenic flexure of the colon passing proximally and distally within the lumen of the colon. Despite the second colonoscopy the bleeding source could not be found. Patient was given an additional unit of blood. She was monitored further. She had a period of time after the colonoscopy where she had severe generalized abdominal pain but this resolved by the following day where she then began to have diarrhea but no further hematochezia or bleeding was noted. she was discharged on 6/16/21 home. Of note this is the patient's fourth ER visit and or hospitalization since receiving her COVID-19 vaccinations. CT showing no acute abnl and again diverticulosis. She received her 1st moderna covid 19 vaccine on 3/9 and her second on 4/9/21. she has had 2 hospitalizations since her vaccinations and 2 er visits 3/13 at another er noting increased blood sugars, blurred vision and a headache since her covid vaccine on 3/9 and 3/18 for fatigue, high blood sugars
67 2021-06-23 palpitations, heart rate irregular, heart rate increased A few weeks after receiving the second dose, I started having heart palpitations. I noticed that it ... Read more
A few weeks after receiving the second dose, I started having heart palpitations. I noticed that it would beat real fast. I could feel it more at night when I would lay down. It didn't affect me when I was exercising, but I experienced heavy beats. My father has heart valve problems so I visited with my doctor on 04/27 and he did an EKG. The EKG came back normal. As of today, I still have a heavy beating heart. It's not fast anymore, but it still beats hard. This mainly happens at night, when I bend down or lift something heavy.
67 2021-06-24 blood pressure increased I previously reported a rheumatoid arthritis flare up, which has lessened with the help of cortisone... Read more
I previously reported a rheumatoid arthritis flare up, which has lessened with the help of cortisone shots in my arm and shoulder. BUT since then, I have developed terrible heartburn - GERD - and am going to a gastroenterologist in July, AND, my blood pressure has gone up to about 150/100 daily. My doctor will not relate these things to the vaccine, but I do. She is having a stress test run, but I know all of this started with the second vaccine dose. I believe I had Covid in February of 2020, coming home from a trip, but since they would do no antibody testing here, before the vaccine, I was stuck taking it.
67 2021-06-25 heart rate decreased Later that day - blinding headache that lasted for 5 days, utter fatigue (3 days); nausea; joint pai... Read more
Later that day - blinding headache that lasted for 5 days, utter fatigue (3 days); nausea; joint pain, stiffness and aching (5 days); sore arm (unable to raise - 3 days, discomfort lasted 5-6 days). May 8 - Telephone appt with physician at 9:30am re - severe shortness of breath, ankles swollen, prolonged 'fluttering' in left leg from knee to ankle. Expressed concern re thrombosis and urge immediate visit to emergency or medical clinic. Phoned emergency number and attended by Nurse around 1130. Pulse very low ( 44) concern re angina, hypothyroidism, blood clots. Saw DR on May 11 - (pulse 60). Follow-up visit May 27 - B12 level low, all other results normal.
67 2021-06-27 heart flutter In retrospect, hearing about heart inflammation, twice I experienced a fluttering sensation across m... Read more
In retrospect, hearing about heart inflammation, twice I experienced a fluttering sensation across my upper chest area. I thought it was related to older age/post-menopause. Went away on its own. Lasted only 30-40 seconds.
67 2021-06-28 pallor, hypotension Severe onset flu s/s. Intense bone pain, muscle pain, weakness , inability to stand, legs buckled tw... Read more
Severe onset flu s/s. Intense bone pain, muscle pain, weakness , inability to stand, legs buckled twice slipping to the floor, unable to think clearly, and generalized Bee Sting sensations, inj, site hard, red swollen. For the next three days following- hypotension- BP 100/60 ( meds held), continued symptoms, pale. Day 4- s/s lessening. Day 5- able to return to normal activity. Day 13 - return on left arm inj. site redness & pain, return of fatigue, illness, weakness. Fingers and feet with same Bee Sting sensations with occasional generalized . Illness rebound for approx. 3 days.
67 2021-06-29 pulmonary embolism pulmonary embolism, treated with blood thinners (heparin for first week and eliquis thereafter). Mu... Read more
pulmonary embolism, treated with blood thinners (heparin for first week and eliquis thereafter). Must continue eliquis for six months and then have another CT scan to determine if it has dissolved
67 2021-07-01 chest discomfort Pt c/o chest pressure, heartburn, R - shoulder pain 10 mins after vaccination -- > relieved w/ rest ... Read more
Pt c/o chest pressure, heartburn, R - shoulder pain 10 mins after vaccination -- > relieved w/ rest and decreased environmental stimuli. BP 168/56, HR 72, RR 18 SPO2 100% -- > 129/78, 78,18, 100% -- > 146/80,69, 18, 99% . Pt stable and released from vaccination site w/ family. Pt had steady gait. Pt was advised to f/u w/ her provider and seek ER if symptoms return or worsen.
67 2021-07-01 heart rate increased Had swelling in my left arm that went from the top of my arm to the elbow, also had the red, itchy,... Read more
Had swelling in my left arm that went from the top of my arm to the elbow, also had the red, itchy, rash that hurt at times. Had bad headache for about two weeks after. I had called pharmacy, where I received the shot and they told me the rash and swelling was common, I also called my allergist, who told me to take Benadryl and put some cortisone cream on it, the swelling lasted for months, it has gone down, but I still have discomfort and the under arm area still hurts and feel swollen at times. I went for a Physical, told Dr and she sent me for a Mammogram and ultrasound of the lymph nodes under both arms. They both came back ok.
67 2021-07-05 heart rate increased Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Hyperventilation-Mild, Systemic: Shakiness-Mild, Additional Details: post vaccination after receiving the modern avaccine, the patient waited for 15 minutes, however returned to the pharmacy complaining of experiencing fast heart beat, along with rapid breething. The patient acknowledged improvement as time went on, however, as precautionary measures EMS was called and the patient was escorted out of the pharmacy. Event after this are unknown
67 2021-07-06 pulmonary embolism pulmonary embolism on 4/3, treated in ER with Eliquis
67 2021-07-08 nosebleed Nosebleeds
67 2021-07-08 palpitations, chest discomfort Chronic fatigue; Long hauler; Sharp pain in head; Pressure on chest area, left arm; Racy heart; Dizz... Read more
Chronic fatigue; Long hauler; Sharp pain in head; Pressure on chest area, left arm; Racy heart; Dizziness worsened; Dyspnea worse; tingling; Numbness; sore throat; runny nose; Pressure around eye; brain fog; Muscle/joint pain; Muscle/joint pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Chronic fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Degeneration of cervical intervertebral disc (The cervical degeneration is not reported to be worsening or improving.) in 2017 and Osteoporosis (Osteoporosis is not reported to be worsening or improving.) in 2019. Concurrent medical conditions included Food allergy, Drug allergy, Long COVID since 06-Jun-2021 and Fibromyalgia since 2018. Concomitant products included BROMELAINS (SOLGAR BROMELAIN) and MULTIVITAMIN & MINERAL for an unknown indication. On 29-Apr-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Chronic fatigue) (seriousness criterion hospitalization). On 14-Jun-2021, the patient experienced CHEST DISCOMFORT (Pressure on chest area, left arm). In June 2021, the patient experienced PALPITATIONS (Racy heart), DIZZINESS (Dizziness worsened), DYSPNOEA (Dyspnea worse), PARAESTHESIA (tingling), HYPOAESTHESIA (Numbness), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), OCULAR DISCOMFORT (Pressure around eye), FEELING ABNORMAL (brain fog), MYALGIA (Muscle/joint pain), ARTHRALGIA (Muscle/joint pain) and NAUSEA (nausea). On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (Long hauler) and HEADACHE (Sharp pain in head). The patient was hospitalized from 14-Jun-2021 to 15-Jun-2021 due to FATIGUE. At the time of the report, FATIGUE (Chronic fatigue) and POST-ACUTE COVID-19 SYNDROME (Long hauler) had not resolved and CHEST DISCOMFORT (Pressure on chest area, left arm), PALPITATIONS (Racy heart), DIZZINESS (Dizziness worsened), DYSPNOEA (Dyspnea worse), PARAESTHESIA (tingling), HYPOAESTHESIA (Numbness), OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), OCULAR DISCOMFORT (Pressure around eye), FEELING ABNORMAL (brain fog), MYALGIA (Muscle/joint pain), ARTHRALGIA (Muscle/joint pain), NAUSEA (nausea) and HEADACHE (Sharp pain in head) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. Patient describes that symptoms vary from time to time and that patient still experiences post exertional fatigue and consistent chronic fatigue daily. Concomitant medications Zahler Iron Complex, Nutri flair complex, Orgain protein powder. Treatment information was not provided Company comment: This case concerns a 67-year-old female hospitalized with a serious unexpected event of fatigue, and nonserious post-acute COVID-19 syndrome, chest discomfort, palpitations, dizziness, dyspnea, paraesthesia, hypoaesthesia, oropharyngeal pain, rhinorrhea, ocular discomfort, feeling abnormal, myalgia, arthralgia, nausea, and headache. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-176735 (Patient Link).; Sender's Comments: This case concerns a 67-year-old female hospitalized with a serious unexpected event of fatigue, and nonserious post-acute COVID-19 syndrome, chest discomfort, palpitations, dizziness, dyspnea, paraesthesia, hypoaesthesia, oropharyngeal pain, rhinorrhea, ocular discomfort, feeling abnormal, myalgia, arthralgia, nausea, and headache. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
67 2021-07-08 palpitations pneumonia; I have experienced my heart pumping; severe pain; coughing; chills; continuous fever.; Th... Read more
pneumonia; I have experienced my heart pumping; severe pain; coughing; chills; continuous fever.; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (pneumonia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant), PALPITATIONS (I have experienced my heart pumping), PAIN (severe pain), COUGH (coughing), CHILLS (chills) and PYREXIA (continuous fever.). At the time of the report, PNEUMONIA (pneumonia), PALPITATIONS (I have experienced my heart pumping), PAIN (severe pain), COUGH (coughing), CHILLS (chills) and PYREXIA (continuous fever.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
67 2021-07-10 chest discomfort 1) 2nd dose Moderna administered 09:39 a.m., Wednesday, 24 Feb a) Within 5 hours of the 2nd vaccine ... Read more
1) 2nd dose Moderna administered 09:39 a.m., Wednesday, 24 Feb a) Within 5 hours of the 2nd vaccine i) Dizziness ii) Slight nausea iii) Extreme soreness at injection site iv) Muscle aches v) Weakness, unable to lift injected arm b) After 8 hours post 2nd vaccine / overnight i) Chills / uncontrollable shaking / teeth chattering ii) Dehydration iii) Severe headache iv) Tinnitus v) Increased nausea vi) Delirium vii) Cold sweats viii) Whole body pain ix) Unable to sleep (due to pain) x) Too weak and too painful to move xi) Cold sweats xii) Chest pulsations- felt like air bubbles in blood line pumping through heart 2) Thursday, 25 Feb a) Unable to rise from bed b) Extreme weakness c) Hard to breathe d) Took one+ hour
67 2021-07-11 low blood oxigenation Chief Complaint hypoxia History of Present Illness Pt is a 67F with PMH of COPD, depression, ... Read more
Chief Complaint hypoxia History of Present Illness Pt is a 67F with PMH of COPD, depression, anxiety, possible Afib, possible CHF who presented as a transfer from OSH for hypoxia in the setting of COPD exacerbation and COVID PNA. She also has a hx of left lower lobe lobectomy many years ago for an infection per patient report. She states that she typically wears 4L o2 at home while sleeping and with exertion, but does not require any at rest. She reports that she completed both COVID vaccines about 1-2 months ago. She did have contact with her daughter who also tested positive recently. She reports that she started to feel dyspneic with minimal exertion at home and took her O2 saturations and found them to be in the 70s, so she presented to the ED. She underwent CTA scan in ED and was found to have left lower lobe collapse, severely calcified and ulcerated thoracic aorta with possible intraluminal hanging thrombus and small penetrating aortic ulcer. She was sent here for further work up and management. She denies any etoh or drug use, but has smoked 1-2ppd for 50 years. Mom and dad with hx of cancer. She denies any fevers, chills, chest pain, tightness, pressure, or worsening dyspnea at rest. She does have a productive cough with yellow sputum production and dyspnea with exertion.
67 2021-07-15 chest pain, chest discomfort, dilation of blood vessels Developed redness, pain and swelling at injection site approximately 2 days after injection. Swellin... Read more
Developed redness, pain and swelling at injection site approximately 2 days after injection. Swelling and pain started migrating into armpit and then into breast. She was experiencing breast vein distention, pain, generalized swelling to L armpit and breast, and a lump in her axilla. The redness, pain and swelling at injection site resolved after two weeks. She noticed the pain to the L breast lasted about 1 month, but she is still currently experiencing breast/axilla swelling and does not feel like this has resolved. She also noticed chest pain and tightness in the chest about 3 weeks after injection. She is not currently experiencing chest pain today.
67 2021-07-18 hypotension About eight hours after the second dose of the vaccine I started to feel bad. My fever was 101 degre... Read more
About eight hours after the second dose of the vaccine I started to feel bad. My fever was 101 degrees and I could not get it under control. It got up to 104 and I went to the ER because I had already taken two Tylenol. I was given fluids and IV Tylenol and it still took 3 hours for my fever to come down. My Pancreatic Enzymes were very high and they did a CT scan. Some of other bloodwork was abnormal as well. I had night seats for a few days afterward. My arm was extremely red swollen and irritated where I got the shot. My blood pressure was low as well and I had to break my Blood Pressure medication in half for about one week. I also stopped taking my water pill because I did not want to become dehydrated. I returned to my doctor one week later and my pancreatic enzymes were back to normal.
67 2021-07-19 haemoglobin decreased, chest pain Fever malaise no appetite muscle aches X 5 days. Hospitalized for dehydration fever chest pain decre... Read more
Fever malaise no appetite muscle aches X 5 days. Hospitalized for dehydration fever chest pain decreased kidney function Hospital stay 5 days Treatment: IV fluids observation
67 2021-07-28 heart rate increased Patient stated that the day after the shot she had extreme fatigue and she went to take a breathing... Read more
Patient stated that the day after the shot she had extreme fatigue and she went to take a breathing treatment her pulse started going up. Patient was transferred to hospital by Ambulance. She was given blood thinners.
67 2021-07-28 hypertension Patient rec'd 1st dose of Moderna vaccine on 7/2/21. Presented to MCR ED on 7/3/21 at ~2145h with c... Read more
Patient rec'd 1st dose of Moderna vaccine on 7/2/21. Presented to MCR ED on 7/3/21 at ~2145h with complaints of weakness, fatigue, confusion, altered mental status, HTN & fever. CMP was normal. COVID-19 screen was positive. Patient was diagnosed with COVID-19 in March, so it is unknown whether this is a relapse or new/separate event. Patient treated with NS x1 liter for hydration, and IBU/APAP for pain, fever, etc. Patient improved with the above and was discharged.
68 2021-01-01 chest discomfort Hot across the chest area, given benadrily 50mg orally and discharged @ 12:32pm with symptoms reliev... Read more
Hot across the chest area, given benadrily 50mg orally and discharged @ 12:32pm with symptoms relieved.
68 2021-01-05 fast heart rate, palpitations, lightheadedness Moderna vaccine EUA within 4 minutes i began to feel faint, heart started pounding ,immediate headac... Read more
Moderna vaccine EUA within 4 minutes i began to feel faint, heart started pounding ,immediate headache and was very shaky. I was laid down, cold compress. It came in waves over a period of 20 minutes. I was given a few sips of water. When it did not resolve I was taken to the ER and given IV fluids. The doctor said I had an adverse reaction to something in the vaccine. The chief of Infectious disease thought I had a vaso vagel response. While I am nervous to get the second vaccine , I will go forward and get it..
68 2021-01-07 oxygen saturation decreased Resident sent to hospital with respiratory distress and low oxygen
68 2021-01-07 fast heart rate, hypertension, blood pressure increased, heart rate increased HYPERtension & Tachycardia Narrative: Increased heart rate and blood pressure following vaccination... Read more
HYPERtension & Tachycardia Narrative: Increased heart rate and blood pressure following vaccination. Required ER visit.
68 2021-01-08 heart rate irregular, arrhythmia 01/06/2021 0900, feeling tired, resting heart rate 94 to 110, normal resting heart rate 74 to 86. A ... Read more
01/06/2021 0900, feeling tired, resting heart rate 94 to 110, normal resting heart rate 74 to 86. A few abnormal heart beats throughout the day....9 PM cardiac arrhythmia , multiple abnormal beats, irregular rhythm lasting for about 1 to 1 1/2 hours. went into a regular heart rhythm. never happened to me before! 01/07. am very tired, heart rate still 90 to low 100's a few abnormal beats throughout day, 01/08 am very tired a few abnormal beats, 3 episodes of abnormal beats and irregular heart rate. 01/09 am heart rate 74to 82 no abnormal heart beats and I feel fine now 10:30 pm feel this events are side effects from Covid Vaccine, afraid to get 2nd dose.
68 2021-01-10 pallor client reported that she feels like she has a lump in her throat. She is hoarse, States she feels sl... Read more
client reported that she feels like she has a lump in her throat. She is hoarse, States she feels sleepy, has difficulty swallowing, and feels swelling in her larynx. Is short of breath. Had pt. remove mask, lips pale, tongue not swollen. No stridor per auscultation. Lungs clear bilaterally. BP 150/90; HR 70: O2 98% on room air. 1231: Emergency services called. Patient had her own liquid benadryl and self medicated with 50 mg of benadryl by mouth. 1241: Emergency services arrived. 1244: BP 154/95; HR 69: sat 100% on room air. Lips pink now. Still SOB especially when speaking. 1250: HR 64: sat i 98% on room air 1300: Declined transport per recommendation of emergency services paramedics. BP 155/97; HR 57: Sats 100% on room air. Speaking with less dyspnea. Emergency services left 1305: patient left facility with friend via personal vehicle. Stable, gait steady. Respirations mild labored with exertion.
68 2021-01-11 fainting MODERNA COVID-19 Vaccine EUA I took the vaccine on Monday Jan 4 at around 9 AM. During the day only ... Read more
MODERNA COVID-19 Vaccine EUA I took the vaccine on Monday Jan 4 at around 9 AM. During the day only pain in the left arm. On Tuesday I felt tired all day long. At 7 PM, I took a Coke inside the fridge and I noticed and told my husband I was not feeling well. I put the coke in the glass, after I took the glass in my hand and then I fainted. Never in my life I have fainted before. I hit my head in the floor. Now I have some bruise in my face, mainly around my left eye. Feeling a little dizzy, I am in quarantine I and my husband are staying home all the time. I have my doctor scheduled for next Thursday.
68 2021-01-13 chest discomfort 10 minutes after vaccine, developed chest tightness with SOB. (has asthma) ; sx persisted after addi... Read more
10 minutes after vaccine, developed chest tightness with SOB. (has asthma) ; sx persisted after additional 15 ' and transferred to ED. Given albuterol nebulizer, sx resolved. EKG wnl - observed for 2 hrs. d/c to home
68 2021-01-14 blood pressure increased Moderna Vaccine Much higher blood pressure than normal beginning 1/10/21 thru 1/14/21. He... Read more
Moderna Vaccine Much higher blood pressure than normal beginning 1/10/21 thru 1/14/21. Headaches and fatigue 1/10/21-1/13/21.
68 2021-01-14 heart rate decreased, loss of consciousness Patient was given Covid vaccine and then was instructed to sit for about 15 minutes. About 5 minutes... Read more
Patient was given Covid vaccine and then was instructed to sit for about 15 minutes. About 5 minutes later after receiving vaccine she passed out and fell onto floor. I went over to provide aid and rolled her over to have her lying face up while another staff member was calling 911. She was still awake and responsive when I proceeded to ask her questions and she informed me she felt "hot all over and dizzy." 911 informed us to keep her lying down on the floor as comfortable for her as possible until EMS arrives on scene. While waiting for EMS to arrive her pulse was low (~40 bpm), but shortly before EMS arrived on scene her pulse rose to a normal heart rate (~80 bpm). EMS then took her to the hospital for further evaluation.
68 2021-01-14 heart rate increased, blood pressure increased Rapid heart beat with elevated blood pressure and pulse. Returned to acceptable level after 1 hour.
68 2021-01-14 loss of consciousness, heart rate decreased Patient received vaccine at 1:48 pm then approximately 5 minutes afterwards fainted and fell to the ... Read more
Patient received vaccine at 1:48 pm then approximately 5 minutes afterwards fainted and fell to the floor while sitting in a chair. I went over and rolled patient over having her lay face up and then proceeded to ask her questions. We had a staff member called 911 while I was helping her. I asked her how she felt and she responded and said she felt "hot all over and dizzy." Her pulse was low (~40 bpm). 911 informed us to lie her down on the floor until EMS arrived which we already had been doing at the time. After getting off the phone with 911, she started feeling better and her pulse returned to a normal rate (~80 bpm). EMS still took her to the hospital for further evaluation.
68 2021-01-15 blood pressure increased, chest discomfort Throbbing head ache, difficulty breathing, lips numbness, chest discomfort, upper back, lower legs, ... Read more
Throbbing head ache, difficulty breathing, lips numbness, chest discomfort, upper back, lower legs, fingers tingling/numbness, high blood pressure 148/83, underarm sweating, feels weak
68 2021-01-16 chest discomfort pain left arm continues, light head, headache, nausea, heaviness in chest, tired, temperature 99.... Read more
pain left arm continues, light head, headache, nausea, heaviness in chest, tired, temperature 99.8
68 2021-01-21 fainting Fainted; Did not feel well; Hit head; A little pain in arm; A spontaneous report was received from a... Read more
Fainted; Did not feel well; Hit head; A little pain in arm; A spontaneous report was received from a 68-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the events, fainted, hit head, did not feel well, and a little pain in arm. The patient's medical history was not provided. Relevant concomitant medications reported included ezetimibe, atorvastatin, and atenolol. On 04 Jan 2021 at 9:00 am, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection. On 06 Jan 2021, the patient reported that she took the vaccine on 04 Jan 2021 and she did not feel anything after but a little pain in her arm. On 05 Jan 2021 around 7:00 pm, the patient went to her fridge for a drink and told her husband she did not feel very well, and then fainted. The patient reported that she hit her head and has never fainted before. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, fainted, hit head, did not feel well, and a little pain in arm, were unknown.; Reporter's Comments: This case concerns a 68-year-old female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of Syncope, the non-serious listed event of Pain in extremity, and the non-serious unlisted events of Head injury and Malaise. Based on the current available information and temporal association between the use of the product and the onset of the events on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
68 2021-01-21 fainting fainted; a little pain in arm; A spontaneous report was received from a consumer concerning a 68-yea... Read more
fainted; a little pain in arm; A spontaneous report was received from a consumer concerning a 68-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainting and pain in her arm. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 04 Jan 2021, at approximately 09:00am, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left deltoid prophylaxis of COVID-19 infection. On 04 Jan 2021, after receiving the vaccine, the patient felt a little pain in her arm. On 05 Jan 2021, at approximately 19:00 the patient fainted after standing up. She hit her head on the floor and had a small bump on her head. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, fainting and pain in her arm, were considered unknown.; Reporter's Comments: This case concerns a 68-year-old female subject with who experienced a serious, unexpected event of fainting and pain her arm. Her medical history and con meds were not provided. The fainting event occurred 1 day after the first dose of the mRNA-1273 study medication administration, after patient stood up, fainted, and hit her head on the floor and sustained a small bump on her head. Treatment for this event was not provided. Very limited information regarding the fainting event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
68 2021-01-22 chest pain Very bad pain at injection site and radiating into my chest, up my neck and down my arm. Raising my... Read more
Very bad pain at injection site and radiating into my chest, up my neck and down my arm. Raising my arm is difficult and extremely painful.
68 2021-01-24 deep vein blood clot, pulmonary embolism Experienced shortness of breath upon minimal exertion 24 hours after having receieved the vaccine. C... Read more
Experienced shortness of breath upon minimal exertion 24 hours after having receieved the vaccine. Called MD 72 hours vaccine received - MD advised hospital ER. Admitted with pulmonary embolism and deep vein thrombosis. Remains short of breath and is on 4L of oxygen. Receiving anti-coagulants.
68 2021-01-24 heart rate increased about 3 minutes after injection I got a flushed feeling. It lasted a couple of minutes. It came b... Read more
about 3 minutes after injection I got a flushed feeling. It lasted a couple of minutes. It came back one more time in about 15 minutes. Again brief a couple minutes. It did not advance. EMS and Doctor checked me for 40 minutes. Only slightly elevated pulse. It was elevated before I left home. It was 100 at home. Got to about 106 doing this episode. Went down to 97 before I left. All other vs-WNL.. LS clear the whole time. O2sat.- 96 up to 100 before I left I really want to get the second shot when I am due. My personal doctor can not give me any answers. I never got out of my car. Did not get any extra care just monitored. Only sore arm later.
68 2021-01-25 chest discomfort Pt had hives and swelling of tongue. She began to report shortness of breath and tightness in her ch... Read more
Pt had hives and swelling of tongue. She began to report shortness of breath and tightness in her chest. She became lethargic and diaphoretic.
68 2021-01-25 palpitations 1/22 Friday- 0800-vaccination received; after about 10 minutes during observation period I felt my h... Read more
1/22 Friday- 0800-vaccination received; after about 10 minutes during observation period I felt my heart pounding which lasted for about another 5minutes; discharged from the vaccination site. About early afternoon, my hands felt warm , face warm and lips dry, heart rate was 100, temperature was 99 , right arm very painful. Temperature runs between 98.8-99.4 ,pulse around 80-90's on Saturday and Sunday. I took extra strength Tylenol every 6-8hrs which helped relieve some pain and fever(tried Advil but this did not help with the arm pain.) Monday morning 1/25/21 woke up and noticed arm pain gone. Temperature was 98.6-98.8 the whole day. No further symptoms like above felt ( so far)
68 2021-01-27 ischemic chest pain, hypertension Moderna Covid-19 Vaccine EUA: fatigue: shortness of breath; heart pain; high blood pressure; runny ... Read more
Moderna Covid-19 Vaccine EUA: fatigue: shortness of breath; heart pain; high blood pressure; runny nose; chills; stomach pain; nausea; body ache
68 2021-01-27 blood pressure increased One week after taking the vaccine I developed significant swelling of the upper left arm at the vacc... Read more
One week after taking the vaccine I developed significant swelling of the upper left arm at the vaccination site that gradually got worse as the day progressed. I also experienced a headache and a severe spike in blood pressure in the afternoon, which led me to think that my reaction might be severe. As a result I went to the local ER where they decided to keep me overnight for observation. The symtoms did not get worse, but I was given steroids and peptid intravenously, as well as Benadryl to counteract the swelling. Today, Jan. 28, I continue to have some swelling in the left arm, as well as redness.
68 2021-01-27 chest discomfort Sensation of anxiety and minor "chest pressure" began 1/25/21 and continued at least through 1/26/21... Read more
Sensation of anxiety and minor "chest pressure" began 1/25/21 and continued at least through 1/26/21. Watchful waiting was recommended.
68 2021-01-27 hypertension, haemoglobin decreased, enlargement of the heart, blood pressure fluctuation, anaemia Pt. was admitted to hospital on 1/6/21 with fatigue, weakness. Pt. was Covid positive in November of... Read more
Pt. was admitted to hospital on 1/6/21 with fatigue, weakness. Pt. was Covid positive in November of 2020. Impression upon admission was fatigue may be due to her aortic stenosis and some hypertensive issues with blood pressure changes. She was anemic. WBC was elevated to 19.2, HBG 10.5, NA-131, K+ - 3.1, Rule out bacterial infection. Potential source could be her heart valve. Also noted to have acute renal failure with BUN of 47 and Creatinine of 2.2 noted. Pt. was transferred to Hospital on 1/8/2021 with dx of aortic stenosis, bacteremia, ARF, Dehydration and anemia. Discharged with dx. of sepsis. Pt. expired on 1/18/21 with dx. of severe sepsis, complete heart block, staphylococcus epidermidis bacteremia.
68 2021-01-28 sinus rhythm 2 hours after vaccine given, experienced jerking in arms, legs were weak, nausea and vomiting and it... Read more
2 hours after vaccine given, experienced jerking in arms, legs were weak, nausea and vomiting and itching, Now, 1 week later, I have a rash on left arm and face
68 2021-01-29 chest pain Day 4 sharp pain deep in lady thigh radiating down left leg Day 6 deep sharp pains in middle of bac... Read more
Day 4 sharp pain deep in lady thigh radiating down left leg Day 6 deep sharp pains in middle of back radiating out through chest. Pain is worse and lasts all afternoon into evening Day 8 pain returns, but this time deep in the right chest and worse. Begins in afternoon and by evening pain is paralyzing, in tears. Attempted to w as l holing on to things to ease the contractions. Yes the pain was as bad a worst contractions from labor. At 3am dressed to go to Ed but decided against it duevti Covid concerns. Pain most server when I was either sitting or lying down. Terrible afraid to take second dose for tear that side effects will be much worse. On the intervening days no pain or paroxysms.
68 2021-01-29 loss of consciousness Dizziness, vomiting, felt Gross, Passed out for around 10 seconds, and was making strange noises wit... Read more
Dizziness, vomiting, felt Gross, Passed out for around 10 seconds, and was making strange noises with some difficulty breathing. Body stiffness. Applied wet towels with cold water on the nape and forehead
68 2021-01-31 blood glucose increased She is having a lot of fatigue w/ swelling of her feet and ankles w/ an exacerbation of neuropathy p... Read more
She is having a lot of fatigue w/ swelling of her feet and ankles w/ an exacerbation of neuropathy pain in her feet and hands This morning she woke up w/ a sore throat in the back of her throat - "not where I swallow" w/ congestion and HA no fever/chills but has felt internally cold and sometimes + body aches - more than normal Blood sugar has been a little higher - diabetic and normally well controlled + cough - has COPD but can hear more of a wheeze and fluidy sound + SOB/DOE - more so than normal
68 2021-01-31 loss of consciousness BEGAN SHIVERING CONSTANTLY UNTIL ASLEEP. WOKE UP ABOUT 8 HOURS LATER FEELING WEAK AND DIZZY. LEANING... Read more
BEGAN SHIVERING CONSTANTLY UNTIL ASLEEP. WOKE UP ABOUT 8 HOURS LATER FEELING WEAK AND DIZZY. LEANING ON COUNTER PREPARING FOOD THEN SUDDENLY WOKE UP LYING ON FLOOR. RESTED IN CHAIR MOST OF DAY. PUSHED GATORADE FOR HYDRATION AND ATE LIGHTLY AND REGULARLY. FELT NORMAL BY 11;00 PM.
68 2021-01-31 fainting difficulty breathing, faintness, extreme weakness, unable to communicate
68 2021-02-01 blood pressure increased, heart rate increased 45 hours after vaccine admin, woke up Sunday AM, and upon eating and hydrating, got vertigo-- dizzin... Read more
45 hours after vaccine admin, woke up Sunday AM, and upon eating and hydrating, got vertigo-- dizziness and vomiting. Unable to keep food or fluids down. (Patient is 68 yrs, and has never ever thrown up.) Elevated heart rate and BP, stress reaction. These symptoms continued for 8 hours. Wound up at ER. Doctors suspect vaccine as cause of vertigo reaction. Received IV to restore fluids. Had an MRI to rule out stroke or heart attack. Released from Hospital Sunday 10:30PM
68 2021-02-01 heart rate irregular MY HEART STARTED BEATING IRREGULARLY LAASTED ON AND OFF ALL DAY
68 2021-02-02 chest pain, chest discomfort I felt foggy and disoriented and tired within a half hour of receiving the vaccine. I felt pain in... Read more
I felt foggy and disoriented and tired within a half hour of receiving the vaccine. I felt pain in my arm traveling to my underarm. After an hour I felt like the inside of my skin was prickly and tingly, my face was flushed and burning. I was so tired I had to lay down. I just stared into space. There was ringing in my ears. My heart rate was a good 20 beats per minute faster than normal. By bedtime, my face was slightly swollen and I was unable to read because the letters were jiggly. I had a traveling headache from the side to the top of my head through my eyes. My breathing was more rapid and shallow. I felt intermittent chest tightness. And pain. The next morning, I felt better, but the prickly skin continued and my chest and back were sore. I had intermittent cramping in my feet and was sore in my joints. My arm was very tender. I was still tired and my heart rate was still elevated. I did not sleep well and got up frequently during the night to walk around. By the third day the prickly skin was almost gone, but I have had cramping in my chest and feet. I am very tired. I still have an occasional traveling headache.
68 2021-02-02 excessive bleeding Moderna COVID-a9 Vaccine EUA - Woke from sleep about 15-16 hours after vaccination with continuous s... Read more
Moderna COVID-a9 Vaccine EUA - Woke from sleep about 15-16 hours after vaccination with continuous sharp cutting sensations in arm pit of arm which received the vaccination. Upper portion of breast also was just tender to touch. The cutting sensation continued for about 24 hours with improvement continuing but 2.5 days later the upper portion of the breast presented bruising/bleeding signs. Picture was taken. Some tenderness.
68 2021-02-03 heart rate increased adverse reaction: within minutes felt faint and dizzy, deep pain in neck, heart rate went up, fullne... Read more
adverse reaction: within minutes felt faint and dizzy, deep pain in neck, heart rate went up, fullness in lips and tingling, face underskin felt swollen, pressure on side of neck,
68 2021-02-04 pallor Starting on the 4th day, itchy in the injection site and pale small light pinkish area was noted; li... Read more
Starting on the 4th day, itchy in the injection site and pale small light pinkish area was noted; light swelling also behind the injection site. On the 7th day, very very itchy and Benedryl cream helped; Redness area got bigger and color intensity increased. Today is the 8th day and still itching and red.
68 2021-02-05 chest discomfort tiredness, headache ( as soon as it was injected) joint pain, nausea, feeling unwell, left arm swoll... Read more
tiredness, headache ( as soon as it was injected) joint pain, nausea, feeling unwell, left arm swollen chest pressure, swelling of my face, eyes - watering - difficult focus, throat - dizziness and weakness
68 2021-02-06 heart rate increased 2/5/2021, headache, rapid heartbeat at 8:30 pm, resulting in insomnia, .moderate inje tin site pain ... Read more
2/5/2021, headache, rapid heartbeat at 8:30 pm, resulting in insomnia, .moderate inje tin site pain 2/6/2021 fever and chills at 3:30 pm with extreme fatigue, pain upon moving arm 2/72021 back to normal
68 2021-02-07 chest discomfort At the 15 min mark patient stated that she was going to sit out in the waiting room just a few minut... Read more
At the 15 min mark patient stated that she was going to sit out in the waiting room just a few minutes longer, patient had experienced some chest tightness. Patient said she wasn't sure if it was from the mask or from the short. Had patient lower mask take some deep slow relaxing breaths, she said it helped a little but was still having the chest tightness. Patient was offered a Benadryl and patient took this. 20 mins later patient was feeling more relaxed and was ready to leave.
68 2021-02-07 loss of consciousness Patient experienced fever of 100.4, chills, diarrhea, vomiting, nausea, dizziness, and joint/body pa... Read more
Patient experienced fever of 100.4, chills, diarrhea, vomiting, nausea, dizziness, and joint/body pain. Patient also passed out and suspects hit head on toilet. There is a scratch on her forehead but no bump.
68 2021-02-07 palpitations, blood pressure increased Classic Anxity attack with upset stomach. Blood pressure spiked, and heart raced. No pain, only te... Read more
Classic Anxity attack with upset stomach. Blood pressure spiked, and heart raced. No pain, only terror feeling. Spoke with NP and seh recommended 2 Benardyrl. If things got worse to go to ER. They did get better. Next day foggy head and still upset stomach, Yesterday was better, stomach still huts but better.
68 2021-02-07 fainting 10 minutes after vaccination patient became unresponsive, staring forward with stiff body, arms flex... Read more
10 minutes after vaccination patient became unresponsive, staring forward with stiff body, arms flexed and hands fisted. She required sternal rub without response. She was incontinent. Episode lasted 1-2 minutes. She had no recollection of the episode. Paramedics assisted, with Temp 97.1, HR 80, B/P 122/80, pulse ox 98%, fingerstick 101. She was transported by ambulance to Hospital. Laboratory assessment was unremarkable for for CMP, CBC, Troponin, Lactic acid. EKG, CXR and CT head were also unremarkable. She was discharged with diagnosis of possible vasovagal syncope episode and instructed to follow-up with her pcp.
68 2021-02-08 blood pressure increased 1:00pmTinglingInFace,Headache,Chills,JointPain,ElevatedBloodPressure
68 2021-02-08 heart rate increased Fatigue Apathy Unusual tiredness Body aches Headache Accelerated pulse Confusion
68 2021-02-08 heart rate increased Awoke 2/4/2021 with flushing to cheeks and swelling from my eyes down to my cheeks. Rapid pulse (>1... Read more
Awoke 2/4/2021 with flushing to cheeks and swelling from my eyes down to my cheeks. Rapid pulse (>120 bpm), and my normal benign tremor was significantly worse.
68 2021-02-09 body temperature decreased Dizziness, such that I couldn't stand Vomiting Body aches Headache Chills Subnormal temperature Diar... Read more
Dizziness, such that I couldn't stand Vomiting Body aches Headache Chills Subnormal temperature Diarrhea Started the morning after the shot and continued for 2 days
68 2021-02-09 cerebrovascular accident 6 days following vaccination patient had a left sided stroke-numbness in face arm and hand. went to ... Read more
6 days following vaccination patient had a left sided stroke-numbness in face arm and hand. went to ER. and stroke was confirmed
68 2021-02-09 fainting Aching, fever, chills, fainting
68 2021-02-10 blood pressure decreased I got the shot within a minute I could feel in my neck, my jaw, my throat and my ear felt like it wa... Read more
I got the shot within a minute I could feel in my neck, my jaw, my throat and my ear felt like it was getting big, and my mouth felt like it was full of cotton and I couldn't swallow. A few days after that my blood pressure was going lower than normal and I felt dizzy, so I reduced my blood pressure medication and kept an eye on it. I also had a huge a lump in my arm and my whole arm was sore. It was red and hot to the touch.
68 2021-02-10 blood pressure increased At time of injection, I immediately had a headache. When I got home my BP was as 140/90. I'm usuall... Read more
At time of injection, I immediately had a headache. When I got home my BP was as 140/90. I'm usually 110/65. I was very tired and took 2 tylenol and took a 3 hour nap.. was very tired for 3 days
68 2021-02-10 nosebleed Moderna COVID-19 Vaccine EUA Short-lived nosebleed 24 hours after vaccination. Very unusual for pati... Read more
Moderna COVID-19 Vaccine EUA Short-lived nosebleed 24 hours after vaccination. Very unusual for patient. No ibuprofen, aspirin, etc. within 10 days prior
68 2021-02-10 palpitations, atrial fibrillation UNCLEAR TIME FRAME BUT DAY OF VACCINATION SHE WAS OBSERVED FOR 25 MINUTES WITH NO REACTION, REPORTS ... Read more
UNCLEAR TIME FRAME BUT DAY OF VACCINATION SHE WAS OBSERVED FOR 25 MINUTES WITH NO REACTION, REPORTS HOURS LATER SHE HAD DIZZINESS AND PAIN INTO HER NECK AND A MILD HA. SHE BEGAN TO FEEL PALPATATIONS. WENT TO URGENT CARE AND WAS IN AFIB.NOW ON OBSERVATION STATUS ON TELEMETRY UNIT. HAS H/O OF AFIB AND DIABETES
68 2021-02-10 palpitations The evening of the vaccine, the patient reported onset of chills, nausea, headache and deep fatigue.... Read more
The evening of the vaccine, the patient reported onset of chills, nausea, headache and deep fatigue. The next day, she had an ongoing deep fatigue, headache, nausea and intermittent palpitations. All symptoms have resolved except for ongoing nausea, intermittent headaches and fatigue.
68 2021-02-11 heart rate increased Fast heartbeat, dizziness weakness, pain, swelling rash and hardness at site, complete fatigue, hea... Read more
Fast heartbeat, dizziness weakness, pain, swelling rash and hardness at site, complete fatigue, headache, muscles feel like being torn apart, joint ache, chills, nausea and vomiting. I was so sick for over a week. I had stomach contents keep coming up and causing burning in my esophagus. Started to feel better on day 8 after shot.
68 2021-02-11 fast heart rate I had a 3:00 pm dose first dose of the Moderna vaccine yesterday 2/11/21. 8 hours later I had ... Read more
I had a 3:00 pm dose first dose of the Moderna vaccine yesterday 2/11/21. 8 hours later I had a 90 minute episode of tachycardia (up to about 125 bpm - fast for me with a usual rate of 50) and I can't say if the rhythms were off - it was just a very uncomfortable pounding in the chest. I certainly intend to get the next shot on March 11 but is there anything I should do if/when this happens again? Thanks.
68 2021-02-12 chest pain Chest Pain 10 minutes after vaccine administered. Had previous history of anaphylaxis to penecillin ... Read more
Chest Pain 10 minutes after vaccine administered. Had previous history of anaphylaxis to penecillin . Transported to Medical Center via ambulance
68 2021-02-12 heart rate increased, heart rate irregular I got covid arm within 24 hours and irregular heartbeats at least 30 times during waking hours. They... Read more
I got covid arm within 24 hours and irregular heartbeats at least 30 times during waking hours. They were also much more noticeable. I had this same reaction after the first dose as well. It took approximately 3 weeks for my heart to settle down and get back to just a few episodes of irregular heartbeats daily.
68 2021-02-13 blood pressure increased Severe Body / joint pain, fever, chills, headache, vomiting, elevated BP,
68 2021-02-13 heart rate increased, palpitations Pounding headache Feeling like my jaw and throat were locking up Heart pounding and increased heart ... Read more
Pounding headache Feeling like my jaw and throat were locking up Heart pounding and increased heart rate Tremors worse than normal Chills Swelling at site of shot
68 2021-02-13 palpitations Within 45 minutes I had rapid heart palpitations and felt nauseas.
68 2021-02-14 chest discomfort Moderna COVID-19 Vaccine EUA. Patient reported lightheadedness, flushing, and chest "heaviness". Pa... Read more
Moderna COVID-19 Vaccine EUA. Patient reported lightheadedness, flushing, and chest "heaviness". Patient vs stable WNL and transient lightheadedness. Persistent chest "heaviness". Patient transferred to ED for further evaluation via ambulance.
68 2021-02-14 loss of consciousness Maybe 5:00 a.m. woke up and needed to use the restroom, got up slowly and walked to the Bathroom slo... Read more
Maybe 5:00 a.m. woke up and needed to use the restroom, got up slowly and walked to the Bathroom slowly; I passed out and fell on the floor; not sure if my head hit the floor or just the trash barrel. I fell on my right side and the bathtub was at my back. When I realized where I was, I knew I still needed to use the restroom; I meneuvered myself slowly and carefully; I did use the restroom and then I carefully went back to bed.
68 2021-02-15 chest pain Nausea Muscle aches and cramping Back and chest pain Headache Swelling and itching at injection site... Read more
Nausea Muscle aches and cramping Back and chest pain Headache Swelling and itching at injection site Low grade fever Chills Beginning 02/15 and continuing today: 02/16/2021
68 2021-02-15 heart rate increased Was fine on Sunday, while at work on Monday, starting to feel a little dizzy, her eyes became blurry... Read more
Was fine on Sunday, while at work on Monday, starting to feel a little dizzy, her eyes became blurry. By the time that she looked in her rear view mirror her face was swelling up. Her face started to burn, fast heart beat, and dizziness. Her neck started to burn as well. She looked at the side effects. She called her doctor and took 2 Benadryl as she recommended, and took a nap. Her doctor told her to continue taking the Benadryl and to call us to report the reaction. She still has the swelling and the burning sensation in her face, and is still getting a little dizzy but it comes and goes. The fast heartbeat comes and goes as well.
68 2021-02-15 loss of consciousness, palpitations Moderna COVID-19 Vaccine EUA. Patient got suddenly very hot, sweaty, shaky, heart palpitations, and ... Read more
Moderna COVID-19 Vaccine EUA. Patient got suddenly very hot, sweaty, shaky, heart palpitations, and proceeded to pass out and resulted in a head injury when head hit the floor.
68 2021-02-15 oxygen saturation decreased, chest discomfort I started having a fever and very short of breath. My oxygen dropped to 85 and was having chest disc... Read more
I started having a fever and very short of breath. My oxygen dropped to 85 and was having chest discomfort, tightness.
68 2021-02-16 blood glucose increased patient called and reported elevated blood sugar
68 2021-02-16 blood pressure decreased, hypertension Pt c/o feeling the room spin, lightheadedness, diaphoretic. Nsg Assess - A/O x 4, speech clear, skin... Read more
Pt c/o feeling the room spin, lightheadedness, diaphoretic. Nsg Assess - A/O x 4, speech clear, skin warm, pk, slightly flushed. Lungs clear bilateral, heart tones tachy - S1S2, BP 160/72, HR 96. Pt sitting with feet elevated. Cool washcloth to forehead. Left arm site without signs of local reaction. Daughter called to room to calm pt. Pt sat for 30 min - BP decreased to 120/82, HR 86, reg. No resp distress, skim W/D.
68 2021-02-16 chest discomfort Moderna COVID-19 Vaccine EUA Had Covid beginning 12/24/2020 with a positive test 12/28/2020. Within... Read more
Moderna COVID-19 Vaccine EUA Had Covid beginning 12/24/2020 with a positive test 12/28/2020. Within 8 hours of receiving the first vaccine I got a bad headache, my chest felt heavy again, I was nauseated and felt a general malaise - all symptoms I had experienced with Covid. These symptoms lightened over the next few days, but I developed a cough again, and my headache continued off and on through day 5.
68 2021-02-16 hypotension, oxygen saturation decreased high fever, loss of ability to ambulate, fell on floor. Taken to hospital by ambulance. Low blood ... Read more
high fever, loss of ability to ambulate, fell on floor. Taken to hospital by ambulance. Low blood pressure, low oxygen, numerous labs were outside of normal limits,, elevated lactic acid. Received methyloredbuise 60mg every 6 hours (I think three times) Admitted on Feb 14th. Discharged on Feb 16th.
68 2021-02-17 nosebleed Day after started to experience fatigue that still continues and with occasional low grade fever. .... Read more
Day after started to experience fatigue that still continues and with occasional low grade fever. .Also experienced bloody nose and sniffles. One week later developed swelling and rash at injection site and had some muscle aches, occasional low grade fever. Feels like a case of the flu that just drags on.
68 2021-02-17 fast heart rate After 20 minutes of obtaining patient (me) felt a rapid heart beat (i.e., Tachycardia) and called nu... Read more
After 20 minutes of obtaining patient (me) felt a rapid heart beat (i.e., Tachycardia) and called nurse over who in turn got the Doc who was on call for the drive through to come over. Confirmed rapid heart beat and said I need to remain under observation and he would come back again in 5 minutes. After he left had intense bowel and abdominal pain. He came back and rapid heart beat subsided and I left and went home. Continued to have abdominal pain and it was severe for next 36 hours along with a headache. Felt a bit better after 36 hours but still after 72 hours abdominal pain continued again and took a dose of Imodium. Did not feel well systematically as well and called health care professional and got an emergency appointment for the next morning at 8:00 am. Unfortunately, after talking with Dr. next day I began to feel depressed with suicidal ideation involvement, this was approximately 90 hours after getting that damn shot. As a professor of psychology I only every had severe depression with suicidal ideation occur once before and that was after I was giving a new allergy medication which they had to take me off of after one week. It is obvious to me that you people rushed the science on these vaccines and were pushed to come up with a vaccine before "he should not be named was still President". Shame on you for not completely vetting the science and shame on the people who made millions off of these vaccines. In no way were people that have special genetic underpinnings such as myself including in the clinical trails. I read the findings of the clinical trails and it is disconcerting to know that instead of a 2% adverse reactions for the Moderna shot it has now being estimated that 25% or the population has an adverse event after the first shot and now can not get the 2nd and 45% of people who are getting the shot are suffering the ill effects from mRNA and these nano particulars and what is now appearing to be a problem with the lipids (i.e., polyethylene glocol). Stop experimenting with all of us and use the tried and true platforms, even if they are less effective. Or better yet stop ridding by the seat of your parents and get your protocols in order which allows people to choice for themself, in consult with they physician, of which is best for them.
68 2021-02-18 blood pressure decreased Felt like she was going to faint, nausea, stomach pain, felt hot. Observed and called paramedics. Th... Read more
Felt like she was going to faint, nausea, stomach pain, felt hot. Observed and called paramedics. They took charge of her and took her to hospital. She came back to the pharmacy later in the afternoon and said her blood pressure had dropped very low. She was fine when she came back and thanked us for helping.
68 2021-02-18 chest discomfort Patient experienced tightness in her chestr 15 minutes after vaccenation. Onsite EMS was called vita... Read more
Patient experienced tightness in her chestr 15 minutes after vaccenation. Onsite EMS was called vitals were taken BP 1730/84 100% O2 room air HR 87. Symptoms began to subsidiry patient stated she expressed anxiousness before vaccination.
68 2021-02-18 hypertension, heart rate increased, atrial fibrillation, heart rate irregular Moderna COVID-19 Vaccine EUA. Monday, 2-15-21. 11:45 am. ? Received first dose of Moderna Covid-19 ... Read more
Moderna COVID-19 Vaccine EUA. Monday, 2-15-21. 11:45 am. ? Received first dose of Moderna Covid-19 vaccine. 12:30 pm. ? Headache developed. 8:00 pm. ? Watching TV noted irregular heartbeat, and a minute later, increase in respiration rate. That lasted 20 minutes at the most, and then went away. Went to bed at 10 pm and slept well. Tuesday, 2-16-21. 7:00 am. ? In kitchen. Lightheaded, increased respiration, feeling like I?m going to pass out, so I quickly sit down. Two minutes later feel fine. Went about making breakfast. This happened two more times. Realizing this might be a reaction to the vaccination, went to urgent care. Doctor listened to my heart, ordered EKG and result showed that I was in atrial fibrillation (A-Fib). NO previous cardiac issues, no high blook pressure, no diabetes, never a smoker, not obese. Ambulance was called to take me to Hospital. Another EKG confirmed still in A-Fib. Blood drawn. Hooked me up to a wireless/remote heart monitor. Still in A-Fib, elevated heart rate, higher than normal blood pressure. Kept overnight in hospital awaiting more test results, continuous monitoring, and with ECG ordered for Wednesday morning and then consultation with cardiologist. Wednesday, 2-17-21. 11:45 am., ECG done. Still in A-Fib. ECG shows no signs of blood pooling or clotting. Cardiologist proposed courses of action, starting with what makes sense based on current conditions: A cardioversion. Having done thousands (his words) and given my great state of health otherwise, and very low risk for complications, a cardioversion is agreed to. That would happen immediately after first doing a Tee (transesophageal echocardiography) to look at the back of my heart. Then if all looks clear, no clotting, proceed with the cardioversion procedure. 3:00 pm., anesthesiologist asks if I have any further questions. I didn?t. He sedates me. At 3:17 pm. I open my eyes, see the cardiologist standing at the foot of the gurney giving me thumbs up. I returned the thumbs up and said to him, ?good job.? Heartbeat successfully restored to normal rhythm by the cardioversion procedure. 6:00 pm. (approximately) - Discharged from hospital with prescription for Eliquis and Lopressor, and instructions for follow up appointments with primary care physician, and with cardiologist.
68 2021-02-18 troponin increased, chest discomfort, heart attack I did experience some headache and lethargy on Sat. so laid low. I did go for a walk about 3:30 walk... Read more
I did experience some headache and lethargy on Sat. so laid low. I did go for a walk about 3:30 walking up hill at times as is usual. I did have an appetite and prepared dinner. I did not go to work (child play therapist). Sunday I felt more myself and did notice the soreness in my arm was surely not as bothersome as with the first shot. Had a very active day, no walk but yoga class. Prepared a nice dinner for VD and settled in to view television later in the evening. Strangely, the memory of the exact nature of how this started eludes me, but I do recall experiencing discomfort in the very upper extremities of my chest. Sharing this with my husband he wondered if it may have had something to do with sleeping on my right side cramping the rib area due to not sleeping on my left side because of the shot. I also pondered if it might be related to my gym workout on Thursday ? I recall feeling tired and headed to bed. I recall awakening to use the bathroom and feeling a slight brief bout of dizziness. When I did awaken the next morning the chest discomfort was still present to I called the Health Center and was advised to go to the ER. The EKG was fine. The troponin level was elevated to 0.19 so I was told I had suffered a mild myocardial infarction and I was going to the ICU.
68 2021-02-20 chest discomfort Occasional Tightness in Right mediastinum/lung area since date of shot.
68 2021-02-20 heart rate irregular within 30 seconds of the injection I felt my breathe slow up , got dizzy and heartbeat was beating i... Read more
within 30 seconds of the injection I felt my breathe slow up , got dizzy and heartbeat was beating irregular. The doctor can over , took my blood pressure, pulse rate and stayed with me and told me to concentrate on my breathing. He said my heart was beating with an extra beat but believed that was maybe the way my body reacted to stress. Symptoms got less in 5 mins,although I felt weird, it took everything I had to drive home, was on the verge of going in panic attack, had high anxiety and felt choppy like, like shakey nerves. I am still having these symptom today, so it's4 full days now.
68 2021-02-20 lightheadedness Patient received vaccine around 3:00 pm on 2/14/21. Around 7:00 am on 2/15/21 she went outside to wa... Read more
Patient received vaccine around 3:00 pm on 2/14/21. Around 7:00 am on 2/15/21 she went outside to walk her dogs and began to have "tunnel vision". She says she almost passed out. She proceeded to sit down on a chair nearby. Patient was feeling clammy and sweating. Husband came out to help her back into the house. He took her blood pressure reading and it was 79/50. He claims it came back up pretty quickly. Patient says she put wash cloth on face and relaxed for that half of the day. By 1:00 pm that afternoon she felt fine.
68 2021-02-21 low blood platelet count, platelet count decreased Patient was diagnosed with Immune Thrombocytopenic Purpura on 2/21/2021. -petechial rash, bruising -... Read more
Patient was diagnosed with Immune Thrombocytopenic Purpura on 2/21/2021. -petechial rash, bruising -Platelets 4 thousand at hospital admission -Patient is receiving prednisone and IVIG with improvements in platelet count currently
68 2021-02-21 loss of consciousness headache and stomachache for 3 days, passed out at 1:30 AM Feb. 11. Life squad called BP 90/60. Sw... Read more
headache and stomachache for 3 days, passed out at 1:30 AM Feb. 11. Life squad called BP 90/60. Swelling of left upper arm, swollen lymph node under left arm that lasted 4 days
68 2021-02-22 blood pressure increased BP 180/100 , repeat 170/90 Pulse Ox 96 While sitting in observation pt reported having an itchy ar... Read more
BP 180/100 , repeat 170/90 Pulse Ox 96 While sitting in observation pt reported having an itchy area on her left wrist. Pt reported a history of CT Scan Contrast Dye and seasonal allergies. Pt was evaluated by EMS paramedic. Pt declined transport to the ED despite recommendation and education on precursor to anaphylaxis. Pt signed refusal with EMS. Pt reported she often gets itchy for no apparent reason. Pt stayed at clinic in observation for over 45 minutes with no progression of itchiness or other symptoms. . Pt was given ED precautions.
68 2021-02-22 chest pain I had the virus in August of 2020 for 30 days until symptom free. ON 2/6/2021 received first vaccin... Read more
I had the virus in August of 2020 for 30 days until symptom free. ON 2/6/2021 received first vaccine injection. within 3 minutes a light headache started. That evening, rash and itching on right fore-arm and under chin. took benedryl. Woke at 3:30 am on 2/7 not feeling well and left arm very sore and could not touch. 6:30 am - chills with severe body shaking and 101 temp. 7:30 am 102.2 took tylenot 8 hr 650 mg. Oxygen at 96, heart rate at 76 and BP 117/68. 8:00 am 101.9 temp. 10 am 100.6 temp. 1:30 pm 102.9 temp. 2:00 pm 103.3 Took Tylenol, extra strength 2 tabs. 8:30 pm used inhaler due to chest pains 101.3 temp. took benedryl. Oxygennn @98 HR-82 BP 145/77. 11.00 pm 103.3 temp. took 2 tylenol. Mon 8:00 Monday am continued/ 100.2 temp oxygen 97 HR-70; 99.2 temp BP 110/71. 7 pm. took Benedryl for congestion. Quit taking stats. Fatigue and rest took play at this point. Since then have had intermittent low grade fever in 99.2 to 99.9. Same with headache and extreme fatigue. Have high risk husband that I take care of . He had his first vaccine at same time. No side effect at all. I am scheduled for 2nd vaccine on March 6th. I am very apprehensive about taking it with this reaction. Please advise/recommend if I should proceed. My PCP stated that these reactions were evidence the vaccine is working. Is this because I had the virus??? Both the virus and vaccine have been really hard on me. I am usually a very active person and since August, I have been struggling with fatigue. First time in life. Thank you.
68 2021-02-22 excessive bleeding, loss of consciousness I started seeing stars after showering the morning after receiving my shot and eventually blacked ou... Read more
I started seeing stars after showering the morning after receiving my shot and eventually blacked out, fell, and struck my head. When I came to, my head was bleeding where it struck the floor and I was in a cold sweat. I crawled to my phone and called 911. They arrived and checked me out, settled me on the couch and gave me tylenol, spoke with a doctor on the phone, and eventually told me that I could get a friend to take me to the ER if I wished. However, my husband is disabled and could not be left alone, so I'd have had to find another friend to stay with him. Although I might have a concussion, my condition seemed OK and I have not had any other severe symptoms so I have not sought further medical attention.
68 2021-02-22 hypertension Developed stroke like symptoms with hypertension on 2/19/2021. treated on 2/22/2021 for bells palsy... Read more
Developed stroke like symptoms with hypertension on 2/19/2021. treated on 2/22/2021 for bells palsy with left sided facial droop and severe hypertension at dr office.
68 2021-02-22 hypertension 2/15/2021 diarrhea thru 2/20. Starting on 2/19/2021 Left side facial numbness NOT paralysis. HIGH BL... Read more
2/15/2021 diarrhea thru 2/20. Starting on 2/19/2021 Left side facial numbness NOT paralysis. HIGH BLOOD PRESSURE> 200/88 without intervention. Severe headache , nausea and vomiting, generally feeling very bad. No fever.
68 2021-02-22 loss of consciousness Passed out; Felt like two sticks in her stomach; Feeling of a warm flush; Fell on head; Sore arm; A ... Read more
Passed out; Felt like two sticks in her stomach; Feeling of a warm flush; Fell on head; Sore arm; A spontaneous report was received from a consumer concerning a 68-years-old, female patient who experienced feeling of a warm flush, sore arm, felt like two sticks in her stomach, passed out and fell on head. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 15 Jan 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 01ZC207] intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient felt like two sticks were in her stomach and then a feeling of a warm flush going through her body. She also had a sore arm. Patient felt like she was going to pass out and did pass out and fell on her head. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events feeling of a warm flush, sore arm, felt like two sticks in her stomach, passed out and fell on head were considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
68 2021-02-23 hypotension Narrative: Patient notes having rushed to the vaccination visit without eating/drinking or checking ... Read more
Narrative: Patient notes having rushed to the vaccination visit without eating/drinking or checking her blood sugar. After vaccination, she proceeded to go to her nephrology appointment and then to go shopping. On her way home driving (>4 hours after vaccinatino), she began to experience lightheadedness and then next remembers being surrounded by EMS and police and being told her blood pressure was low. At that time, she denies pruritus, flushing, angioedema, LOC, SOB, wheezing, palpitations, nausea or vomiting. Per chart review she was found to be driving erratically - with EMS reporting BP 60/30 initially and subsequent improvement to 80s/50s with administration of IVF. There was no LOC reported at/during the event, which was confirmed by Patient today. She notes having been observed o/n and then instructed to change some of her medications. Today, she states that she is feeling "ok". She again rushed to today's vaccination appointment, but had eaten toast and cocoa this morning. She has not yet checked her blood sugar. Discussed concerning adverse effects of vaccination, including anaphylaxis and immediate allergic reactions and ER precautions-for which she was able to state verbal understanding. She was provided with water and consumed a bag of trail mix while waiting for 30 minutes post vaccination. During the post vaccination period, she did not experience any side effects and was able to ambulate using walker out of clinic w/o difficulties.
68 2021-02-23 palpitations Beginning about 9pm increasing soreness and pain in arm -by midnight arm was too sore and stiff to l... Read more
Beginning about 9pm increasing soreness and pain in arm -by midnight arm was too sore and stiff to lift above waist Beginning about 11pm headache, full body joint pain, full body body aches, chills, fever approaching 99 (NB - my typical body temp is 97.2 - 97.4). As night progressed the symptoms worsened - about 2am intense back pain between shoulder blades radiating to chest, heart was pounding, temperature increased to 101 About 3am was in extreme pain throughout entire body, severe chills/shaking, fever was 102.2, experienced minor urinary incontinence About 3:30am I finally had to take 2 Advil - within an hour the symptoms had lessened and temp had dropped to 100 By noon (22 hours after injection) I was experiencing only mild body aches, temperature was normal, left arm remained sore but I could move it - other side effects had resolved I am very stoic and have a fairly high pain tolerance. I had no side effects after shot 1. After shot 2 I was sicker than I have ever been in my life ?- for several hours I was concerned I was going to die.
68 2021-02-23 fast heart rate Rapid heart beat, tingling in right arm, disturbed sleep. I suffer with anxiety and am no longer on... Read more
Rapid heart beat, tingling in right arm, disturbed sleep. I suffer with anxiety and am no longer on medication for it. I am no sure if this is a reaction to the vaccine or my anxiety worsening. I have consulted my doctor for advise.
68 2021-02-23 fast heart rate Tachycardia, Flushing, Feeling weak
68 2021-02-24 body temperature decreased the typical (dizzy nausea minute 5-20) headache, low temp 2nd day, 2nd day evening, I was concentr... Read more
the typical (dizzy nausea minute 5-20) headache, low temp 2nd day, 2nd day evening, I was concentrating on breathing, keeping nose open, throat too, mucous concern.
68 2021-02-25 blood pressure increased Patient experienced dizziness and high blood pressure (140s/100s) and tongue tingling. Patient was m... Read more
Patient experienced dizziness and high blood pressure (140s/100s) and tongue tingling. Patient was monitored for 30 minutes and the dizziness improved. We gave her a bottle of water to drink and crackers and she said she felt better. The tongue tingling went away as well before the 30 minutes ended. Her blood pressure was retaken before she left and it remained in the 140s/100s. She said this is higher than her normal but it could be due to anxiety.
68 2021-02-25 oxygen saturation decreased I received my 2nd Moderna COVID-19 Vaccine EUA on 2/24/2021. Had only a mild sore arm. When I woke t... Read more
I received my 2nd Moderna COVID-19 Vaccine EUA on 2/24/2021. Had only a mild sore arm. When I woke the next morning I was fine with still just a mild sore arm. Then 21 hours after my vaccine I started getting chills and fever 101.9 which I read I could have after the vaccine. The unusual thing that occurred was how cold my hands got, they became so cold they hurt. I had a difficult time warming them up when I checked my oxygen level it was low, 89. I assume because they were so cold. This was very uncomfortable. I have never experienced this freezing hands before, and I have not seen it has a symptom so I wanted to inform someone. I started taking Tylenol with my fever and it broke overnight and I feel fine now.
68 2021-02-25 fainting Dose 2 received 9:50 a.m. on 2/19/2021. By 4:00 p.m. chills. By 7:00 a.m. 2/20/2021 chills, headache... Read more
Dose 2 received 9:50 a.m. on 2/19/2021. By 4:00 p.m. chills. By 7:00 a.m. 2/20/2021 chills, headache, nausea, vomiting, muscle aches, and dizziness. The dizziness resulted in fainting and falling at approximately 9:00 a.m. Headache similar in intensity to migraine.
68 2021-02-26 nosebleed Woke up with blood on my bedsheets, I had a bloody nose sometime during the hours of midnight and 4a... Read more
Woke up with blood on my bedsheets, I had a bloody nose sometime during the hours of midnight and 4am
68 2021-02-26 palpitations Patient received vaccine at 1015 am. While waiting in the store for observation, she began to feel a... Read more
Patient received vaccine at 1015 am. While waiting in the store for observation, she began to feel a racing heart, shaking from the inside out, and difficulty catching her breath around 10:30. 911 was called. She stated her throat started to feel tight, dry mouth, and metallic taste and was given an epi pen. The patient stated she started to feel better after the epi pen was administered and declined medical transport when emergency services arrived. Per emergency services, notable negatives include: no hives/rash, no localized reaction, no wheezing, no angioedema, no hypotension, no flushing.
68 2021-02-27 atrial fibrillation about 24 hours after my shot I was in AFIB. I haven't had this problem since my ablation about 5 ye... Read more
about 24 hours after my shot I was in AFIB. I haven't had this problem since my ablation about 5 years ago. I do not know if the vaccine had anything to do with it or if a coincidence, but pharmacist said I should report it. I am still in AFIB and very short of breath.
68 2021-02-27 chest discomfort Painful arm within a few hours of dose. Wrist, arm and hand stiff and painful for three days. Right... Read more
Painful arm within a few hours of dose. Wrist, arm and hand stiff and painful for three days. Right side of neck swollen and hard within three hours of injection. Bad headache especially right side Continuing and current problems since injection; 1. Swollen stiff neck and face ( all over) 2. Exhaustion 3. Stiffness and aching in right arm and hand 4. Throat irritation and discomfort, bouts of sweating and chills, chest discomfort
68 2021-02-27 chest pain, chest discomfort Fifteen minutes after injection, I experienced pain in my left chest. It migrated to the center of m... Read more
Fifteen minutes after injection, I experienced pain in my left chest. It migrated to the center of my chest and could be felt on both front and back. Pain was a dull, squeezing ache that could be mitigated by placing hand over the pain and leaning forward. Pain level was 2. The pain migrated to left shoulder and up left side of neck. Vital signs were normal. A few dry coughs caused medical personnel to offer water, which was declined. The pain was similar to the pain I experienced after drinking contrast medium (now considered an allergic reaction) but without breathing difficulties. The pain went away after an hour and half. Nurses suggested emergency medical care, which I declined.
68 2021-02-27 excessive bleeding Have diverticulosis-bleeding issue and had severe bleed that started on 2/24 and subsided on 2/25-26
68 2021-02-27 palpitations Same day of vaccine, evening time, started with headache, fever, chills, leg/foot cramps, malaise, h... Read more
Same day of vaccine, evening time, started with headache, fever, chills, leg/foot cramps, malaise, heart palpitations, and pain at injection site. This continued, minus cramps, all day the next day. but fever went down towards end of day using Acetaminophen 325mg and Ibuprofen 400mg, alternating, twice during day. The third day and today, fourth day, still body feels tired as if I have had the flu, and have a persistent "hum" in my head, as if a motor is running somewhere nearby.
68 2021-02-28 chest discomfort 11:20am: Pt was in observation area and began to feel like her tongue was weird, strange feeling in ... Read more
11:20am: Pt was in observation area and began to feel like her tongue was weird, strange feeling in chest area (didn't know how to describe). Pt has a history of allergy to wasps, walnuts, almonds. BP 128/82, P66. 11:33am: Lightheaded, transition to laying down. BP: 160/104, Denies SOB. 11:45am: temp 97.7F, EMS arrived and transported patient to local hospital via ambulance.
68 2021-02-28 chest discomfort First two days after vaccine- tired. By day three began experiencing back pain. By Wednesday, Januar... Read more
First two days after vaccine- tired. By day three began experiencing back pain. By Wednesday, January 20th severe back pain and chest tightening. I went first to Urgent Care. Dr. said EKG ok but I should follow up with Dr. or ER. That evening I went to ER at Hospital. By then it felt like my back and chest were in vice. It did not feel like regular back pain- more searing and deep spasms. Had a gnawing kind of feeling in my stomach and esophagus. Pain in upper part of my body....sometimes waves of pain in shoulders and down back half of my arms. ER Dr gave me shot of pain meds and sent me home after a few hours. Vice like feeling subsided but deep muscle pain in back continued.It was not as severe as the previous day. Over the next week it continued to go from severe back to mild.I visited my primary care Dr/PA and tried changing GERD meds from Famotidine to another- no help. Tried muscle relaxers- I just slept on those. About a week after first visit I went to ER again after a bad night of the vice like feeling in chest and back. ER Dr. did CAT scan of heart and lungs. No sign of pneumonia . Since then I have had an endoscope, seen a cardiologist, and an orthopedic Dr. After second dose, reaction came back, but less severe than the first time.
68 2021-02-28 fainting, loss of consciousness severe chills nausea low grade fever stomach cramps PASSED OUT/Fainted
68 2021-03-01 blood pressure increased Severe migraine headache lasting 48 hours. Fatigue. Sore arm. Sleepiness. Body aches and pains. Prol... Read more
Severe migraine headache lasting 48 hours. Fatigue. Sore arm. Sleepiness. Body aches and pains. Prolonged fever not responsive to Tylenol. Fever peaked at 104 degrees at 10 pm (36 hours after injection). At the same time, my blood pressure was elevated to 200/100. Severe symptoms passed after 48 hours. Minor symptoms lasted for 3 full days.
68 2021-03-01 chest pain 4 days after vaccination, she had heart pain, Cardiologist found hives, developed shingles, fever an... Read more
4 days after vaccination, she had heart pain, Cardiologist found hives, developed shingles, fever and in bed for 10 days. Was prescribed antiviral medication for the shingles from the ER.
68 2021-03-01 hypertension In the clinic, patient received second dose of Moderna vaccine at 1630. At 16:40 c/o difficulty brea... Read more
In the clinic, patient received second dose of Moderna vaccine at 1630. At 16:40 c/o difficulty breathing, feeling light headed, tingling lips, eyes puffy. BP 187/77, HR 84, O2 Sat=84. Rapid Response Team (RRT) activated, patient took Benadryl 25mg PO,symptoms not improving, transported to the ED via stretcher with the RRT. In the ED, patient presented afebrile, hemodynamically stable, no acute distress. Physical exam overall unrevealing. No apparent hives, facial swelling, oropharyngeal swelling or wheeze. Patient stated the symptoms feel significantly better. Patient given 25 mg Benadryl and 20 mg famotidine via IV. Observed in the emergency department for almost 3 hours. No resurgence of symptoms, no rash, no wheeze, no nausea or vomiting. Patient discharged home, advised to take another dose of Benadryl later at night, and reevaluate symptoms in the morning. Advised to follow-up promptly with primary care. Strict return precautions given.
68 2021-03-02 blood pressure fluctuation FEELING FAIINT APPROX 20 MINUTES AFTER VACCINATION. B/P FLUCTUATING, AMBULANCE CALLED
68 2021-03-02 loss of consciousness Passed out and fell on the bathroom floor; didn't feel well; Passed out and fell on the bathroom flo... Read more
Passed out and fell on the bathroom floor; didn't feel well; Passed out and fell on the bathroom floor; Nauseated; Arm was sore; A spontaneous report was received from a consumer concerning a 68-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced arm was sore, nauseated, didn't feel well, passed out and fell on the bathroom floor. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, the patient experienced sore arm, not feeling well, nausea, passed out and fell on the bathroom floor. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events arm was sore, nauseated, didn't feel well, passed out and fell on the bathroom floor were unknown.; Reporter's Comments: This case concerns a 68-year-old female who experienced serious unexpected events of Loss of consciousness, along with nonserious unexpected malaise and fall and NS expected vaccination site pain and nausea. The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
68 2021-03-02 platelet count decreased, low blood platelet count acute ITP, platelet count 2,000 with petechial rash, bruising, fatigue, herpes labialis simplex one ... Read more
acute ITP, platelet count 2,000 with petechial rash, bruising, fatigue, herpes labialis simplex one - petechia occurred 7 days post vaccine; hospitalization 9 days post vaccine. responded to steroids and normalized platelet count 180,000 14 days post vaccine
68 2021-03-03 chest discomfort The patient received her 1st Covid 19 vaccine at 11:05 in her left arm. She waited in the parking lo... Read more
The patient received her 1st Covid 19 vaccine at 11:05 in her left arm. She waited in the parking lot for 30 minutes until 11:35pm due to allergies to Bees, ASA, Beta Blockers, PCN, Sulfa and Steroids. She came back in the parking lot at 11:44am and reported that she started having right sided face swelling and chest tightness. O2 sats 95%, HR 88 and BP 140/82. EPI auto injector x 1 administered at 11:48 am in her right thigh. 11:51 am O2 sats 97% and HR 70 and pt reports her chest was feeling better. 11:57 O2 98% and HR 68, 138/80 and pt check her blood sugar and it was 121. 12:08 EMS arrived and the paramedic reported her lungs were clear and her BP was 128/68. Pt refused transport to the hospital and said she would rather go see her PCP. RN called and scheduled her an appt with Dr at 1:00pm. 12:29 O2 92%.
68 2021-03-03 heart rate increased Beginning at 3 AM: Chills, 101.7 fever, headache, total body ache, feeling disoriented, elevated hea... Read more
Beginning at 3 AM: Chills, 101.7 fever, headache, total body ache, feeling disoriented, elevated heart rate (108),loss of appetite. No treatment. I feel worse than when I had Covid! Considering not doing second dose.
68 2021-03-03 blood clot, pulmonary embolism Started dry cough for three day, pain across the lower back began two days after cough. Began intens... Read more
Started dry cough for three day, pain across the lower back began two days after cough. Began intense pain with nausea and cold and clammy sweats. Called the nurse on my insurance who advised to get to the ER.
68 2021-03-04 blood pressure increased Within 6 minutes left side of face, neck and head started getting numb. Had a rash on neck and chest... Read more
Within 6 minutes left side of face, neck and head started getting numb. Had a rash on neck and chest. Blood pressure went up. Got really weak. Was necessary to go to hospital for meds and monitoring. This morning March 6th, still weak with hurting joints.
68 2021-03-05 palpitations Chills, muscles aches, fever of 103.8, crushing headache, pounding heart beat, red swollen arm, hive... Read more
Chills, muscles aches, fever of 103.8, crushing headache, pounding heart beat, red swollen arm, hives
68 2021-03-05 fainting I had chills, muscle aches, and I fainted when I got up to the bathroom, breaking my ankle.
68 2021-03-06 palpitations 11:00pm woke with headache, heart racing, chills, and shaking so hard I couldn't get out of bed. Gra... Read more
11:00pm woke with headache, heart racing, chills, and shaking so hard I couldn't get out of bed. Grabbed more covers and tried to get warm. Had vivid, swirling dreams. 12:30am Did not realize that much time had passed. Still had all the above symptoms. Woke husband to get 2 extra strength Tylenol. 1:00 am Shaking stopped. Still had vivid dreams and headache. 2:00 am Got up. Temp 102F. very thirsty. 8:00am Temp 101F. Took 400mg Ibuprofen. Headache gone 4:00pm Temp 99F 9:00pm took Advil, no temp, just tired. Next day just tired Next day fine
68 2021-03-07 palpitations At approximately, 9:30PM on 03/05/2021 patient reported having injection site/arm pain, dizziness, m... Read more
At approximately, 9:30PM on 03/05/2021 patient reported having injection site/arm pain, dizziness, muscle spasms that alternated between shoulder blades, neck, thighs, nausea, chills, "heart racing and shortness of breath after climbing stairs to bedroom" . Patient stated symptoms lasted through 03/06/2021 and started to improve on 03/07/2021. Injection site continues to be sore.
68 2021-03-07 lightheadedness, hypertension, heart rate abnormal Allergic reaction; Tongue felt full; Did not feel well; Puffiness; Trouble swalloing; rash; Swollen ... Read more
Allergic reaction; Tongue felt full; Did not feel well; Puffiness; Trouble swalloing; rash; Swollen glands; Blood pressure high/ changes in blood pressure; Felt faintness; Feeling hot; Fluid accumulation; Turned a dark, pinkish color/ flushed; Changes in heart rate/ heart was racing; A spontaneous report was received from a health care professional concerning a 68-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced allergic reaction/ hypersensitivity, feeling hot, fluid retention, flushing, presyncope, heart rate abnormal, swelling face, tongue felt full/ swollen tongue, hypertension, dysphagia, not feeling well/ malaise, rash, and lymphadenopathy. The patient's medical history, as provided by the reporter, included anaphylaxis to Keflex, lisinopril and sulfa drugs. Concomitant medications reported included HCTZ, diltiazem, rosuvastatin, isosorbide mono, metoprolol and pepcid. On 25 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On the same day patient experienced allergic reactions, feeling hot, fluid retention, flushing, presyncope, high blood pressure, swollen glands. On 26 Jan 2021, the patient was taken into the hospital and kept there for 6 hours. On 29 Jan 2021, the patient still had faintness. Her heart was racing and she did not feel well. On 04 Feb 2021, her tongue felt full and something did not feel right. The patient's vital signs included blood pressure 190/98 and later 140/80. Treatment details included Benadryl, EpiPen, Ativan, Solumedrol, steroids, and Tylenol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, feeling hot, fluid retention, lymphadenopathy, and rash were considered recovered/resolved on an unknown date. The outcome of the events, flushing, and presyncope, was considered not recovered/not resolved. The outcome of the events, allergic reaction, hypertension, heart rate abnormal, swelling face, swollen tongue, malaise, and dysphagia, was not provided.; Reporter's Comments: This case concerns a 68 Y/O F who had serious unexpected hypersensitivity along with unexpected BP high, heart rate abnormal, presyncope, dysphagia, face swelling, swollen tongue, flushing, feeling hot, malaise, fluid retention, and expected rash, lymphadenopathy. Event onset the same day as first dose mRNA-1273. Treated with Benadryl, EpiPen, steroids. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
68 2021-03-08 fainting Patient had an episode of syncope 6 minutes after vaccination while seated in a chair. Arousal was d... Read more
Patient had an episode of syncope 6 minutes after vaccination while seated in a chair. Arousal was difficult, carotid pulse was difficult to discern. Once conscious, patient seemed like they were going to fall in and out of consciousness, so we kept speaking to her and asking her questions to keep her conscious. Patient began grabbing right upper abdominal quadrant and complaining of pain. She requested ice because she was feeling hot and her abdomen was hurting, ice was provided. AED was connected and 911 was called, no shock was suggested by AED. EMT arrived and took vitals and blood sugar. They found no issues with vitals, but suggested that she go to Hospital for further assessment. She was taken out on a stretcher, but it is unknown to me what resulted after she left the building.
68 2021-03-09 blood pressure decreased Sunday, the day of the shot, I was quite dizzy a couple of hours after the injection and my arm at t... Read more
Sunday, the day of the shot, I was quite dizzy a couple of hours after the injection and my arm at the vaccination site was itchy, but no other significant reactions. The following morning I awoke to a very swollen, hot, red, and rashy-looking upper left arm at the site of the injection. Had a bit of diarrhea twice in the morning. My temperature 100.4 which is 3° higher than normal for me. Later that afternoon, I got dizzy again so I took my blood pressure and it was 90/59 which is low for me. I had been eating normally even though I had a feeling of unease. The most concerning thing was the discomfort in my upper arm and the swelling. It was very localized and looked as if my arm had swallowed a tennis ball. Itchy, red, hot, and very tender. Today is Day 4 and the swelling has subsided but still not entirely gone and it is still quite warm. I've been applying cold compresses and taking some Tylenol.
68 2021-03-09 loss of consciousness Headache, nausea, heartburn, muscle pain, and chills. Passed out cold without any warning signs. Ca... Read more
Headache, nausea, heartburn, muscle pain, and chills. Passed out cold without any warning signs. Called urgent care twice. Severe facial bruising across mouth, nose and both eyes. Small cuts on nose and top lip. Too weak to go to urgent care, self care at home.
68 2021-03-09 palpitations Client presented with shortness of breath, anxiety, diaphoresis at 12:00 pm, 15 minutes after receiv... Read more
Client presented with shortness of breath, anxiety, diaphoresis at 12:00 pm, 15 minutes after receiving first dose of Moderna vaccine at outreach clinic at her apartment residence. 12:03 VS 152/94, 94 bpm regular. 12:05 50 mg of dyphenhydramine IM in her left arm 12:15 Her nebulizer was retrieved from her apartment, during which time client contacted her daughter to come for assistance. 12:20 Reported continued breathing difficulties, but felt the "benadryl was helping" and appeared less anxious. HR 94 (BP deferred while client was calling her daughter) 12:23 she obtained her nebulizer and took an albuterol treatment over 15 minutes, reporting good effect and improvement in symptoms. 12:36 112/68 95 HR sinus rhythm. She still felt like her heart was racing, w/ 95 bpm. Reported feeling "light headed" (counseled that benadryl and albuterol could contribute to this symptom), but "better" and "can breathe easier". 12:50 Daughter arrived, was given report on above, advised to check client's blood glucose, administer insulin if indicated, as ordered and follow with something to eat. Advised to contact client's PCP for further concerns. We will contact client tomorrow to F/U
68 2021-03-10 blood pressure increased Began with stabbing pain in left shoulder that woke me up every 2 hours all night long. Progressed t... Read more
Began with stabbing pain in left shoulder that woke me up every 2 hours all night long. Progressed to massive migraine headache in a wide band across my forehead. Found fluid pooling in a channel from my armpit past my elbow; rubbed on it and raise arm until it went away. Muscles in left arm stopped working; couldn't move my arm; put left arm in a sling. Started feeling like I was burning up with fever, but body temperature was normal 98.8 degrees. Several hours later was having sudden chills and found body temperature had risen to 102 degrees F. Developed high blood pressure for me. The lymph node in my neck were swelling, armpit tender to touch, and left breast tender to touch too. Started icing the back of my neck to take down temp. Put ice on my shoulder to try to cool the pain. I was very frightened and worried that: (1) got sepsis bacterial infection from shot (2) got bad lot of Moderna or (3) Moderna vaccine sat out at room temperature too long and had gone bad. 48 hours after the 2nd dose and after icing, symptoms started to ease.
68 2021-03-10 chest discomfort Instantly felt chest tightness and difficulty breathing, Lasted around an hour. Also couldn't use a... Read more
Instantly felt chest tightness and difficulty breathing, Lasted around an hour. Also couldn't use arm for over a week, and felt like crap for days. Did not report to nurse, just got up and went home. Had no choice. Had a handicapped son with me and he had wandered outside. He cannot be left alone. Got home the feeling lingered.
68 2021-03-10 heart rate increased Symptoms started at 5:15 PM the next day, about 20 hours after vaccination - Vomiting - High heart ... Read more
Symptoms started at 5:15 PM the next day, about 20 hours after vaccination - Vomiting - High heart rate - Suspected seizure (symptoms differed from the past instances) - Loss of coherence (intermittent for 2 hours) Ambulance brought her to hospital, where she was in ER and later admitted. She is still at hospital under observation at this time, with no discharge date set.
68 2021-03-10 pallor patient developed coughing, shortness of breath, lip swelling, hoarse voice, and tightness in throat... Read more
patient developed coughing, shortness of breath, lip swelling, hoarse voice, and tightness in throat. She became diaphoretic and pale. Symptoms worsened and progressed to anaphylaxis without shock. EpiPen was given and placed immediately on oxygen. EMS/911 called. Patient was given nebulized albuterol and placed on exam table. Normal saline drip via IV given. Patient stated allergy to Benadryl so not given. Within 5 minutes color improved, diaphoresis resolved, and hoarseness/shortness of breath resolved. Lips swelling improved. Patient transported in guarded condition by ambulance by to Clinic.
68 2021-03-11 hypotension, fainting 2/4/21: First Moderna - left arm. Sore arm. 5 to 8 days later, rash on arm, under forearm, hand ar... Read more
2/4/21: First Moderna - left arm. Sore arm. 5 to 8 days later, rash on arm, under forearm, hand area. 20 days later, rash on chest and neck. 3/4/21: Second Moderna- right arm. Sore arm, body aches, chills. 3/5/21: fainting (2), dizziness, fatigue, diarrhea, body aches. Stayed in bed. Drank liquids, ate crackers and rice. Low blood pressure: 103/57; pulse 48. 3/6/21 - 3/7/21: Fatigue; low blood pressure: 114/63; 60. 100/61; 82. 106/65; 71. 110/64; 59. Slept 11 to 12 hrs. 3/7/21 - 3/8/21: Basically back to normal. BP normal avg 118/78; 75.
68 2021-03-11 palpitations High fever 102.9 F, chills, headache, pounding heart, red swollen left arm started 12 hours after t... Read more
High fever 102.9 F, chills, headache, pounding heart, red swollen left arm started 12 hours after the vaccine. Tylenol did not stop the headache. Fever remained over 100.4 F for 24 hours. Headache for 2 days. Arm is still red and swollen 3 days later?m feeling ugh better.
68 2021-03-11 pulmonary embolism, deep vein blood clot On March 5th I experienced shortness of breath around 1:30 that lasted for 10 minutes. I had no oth... Read more
On March 5th I experienced shortness of breath around 1:30 that lasted for 10 minutes. I had no other symptoms and it subsided. On 3/9 around 2:30 am I had another episode of shortness of breath that lasted about 5 minutes. I was able to return to sleep. I went to work that morning and had shortness of breath, sweating, and dizziness. I drove myself to the ER where I was diagnosed with an acute saddle pulmonary embolism. I was admitted and started on IV heparin. On 3/10, I was also found to have a DVT in my right leg.
68 2021-03-12 fainting Chills, fainting
68 2021-03-13 chest pain, oxygen saturation decreased 2/05/21 6 hrs after injection my thigh muscles on both legs tightened up and I could not bend at the... Read more
2/05/21 6 hrs after injection my thigh muscles on both legs tightened up and I could not bend at the upper thigh. very painful. 2/09/21 woke up with foggy vision and eyes burned like fire all day. 2/11/21 At work and felt fine until n/v/d hit hard and had to leave work. Shaky. dizzy, lightheaded with chills Could not stop shaking until the next am. 2/13/21 Face was extremely blotchy and very swollen with eyes still red and small. Left eye smaller and more swollen than right. 2/18/21 Developed chest pain. No SOB tongue not swollen. Resp and spo2 down to 94% normally 98 or 99
68 2021-03-13 heart rate increased The following symtoms occurred within a few minutes after receiving the vaccine as I sat in the wait... Read more
The following symtoms occurred within a few minutes after receiving the vaccine as I sat in the waiting room: 1. difficultly breathing 2. fast heartbeat 3. brain fog/dizziness. These symptoms went away within approximately 5 minutes. The next morning I woke with a slight headache which didn't last very long. I had significant discomfort in the left arm at the injection site. It felt like someone had inserted a balloon in the muscle. It hurt to raise my arm to 90 degrees and above my head. I became less aware of it about 9:00 pm the following night. I called my doctor to report the side effects and it was recommended that I take 2 extra strength tylenol. I still feel some discomfort at the injection site.
68 2021-03-13 fast heart rate Sore right arm Took naproxen 220mg 6 pm. No relief. Headache , Nausea, tachycardia , sweating , ... Read more
Sore right arm Took naproxen 220mg 6 pm. No relief. Headache , Nausea, tachycardia , sweating , faint feeling, abdominal cramping 11:00pm Vomited x 1 at 11:30pm Severe Diarrhea started at 11:30 and lasted for next 20 hours. I did not eat any food for the next 20 hours. Only took clear liquids. 1:30 am 3/13/2021 zofran 4 mg some relief of cramping. No relief of diarrhea. Imodium otc
68 2021-03-14 lightheadedness I initially felt fine after the injection. Approximately 15 minutes after receiving the vaccine I f... Read more
I initially felt fine after the injection. Approximately 15 minutes after receiving the vaccine I felt pain in my left arm then felt nausea, light -headedness ,dizziness nearly syncope. I did not pass out. I recovered with in 10-15minutes. I had no respiratory symptoms and no rash or swelling. I was taken to the ER and released shortly after. I had no other symptoms aside from a mildly sore arm for a day. I have had no subsequent symptoms.
68 2021-03-15 chest discomfort, chest pain, palpitations Body aches, chest pain/tightness, diffusely throughout chest with palpation, especially around pacem... Read more
Body aches, chest pain/tightness, diffusely throughout chest with palpation, especially around pacemaker site
68 2021-03-15 chest pain, platelet count decreased Sent: 3/4/2021 7:55 AM Subject: Non-Urgent Medical Question For a full week now... Read more
Sent: 3/4/2021 7:55 AM Subject: Non-Urgent Medical Question For a full week now, I have been battling diarrhea and a very hyperactive stomach and intestines. Provider prescribed some bentyl Sunday to ease my cramping. At early onset I had some nausea too. I'm wondering if I don't need some blood work, whatever you think and maybe recheck my TSH too. Dr. already ordered a UA with culture which were both negative. That was done because of back pain over left kidney a couple of weeks ago. Diagnosis: Theo. My intestines have never been right since my surgery, but this gassiness and hyperactivity is much more extreme. I tried Metamucil and it blew my guts up even worse. I know I'm due for a CT scan. I see Dr. March 22. I'm trying to hold off until then because I want to discuss with him why I prefer to have all scans at specific facility. I just wanted to get your advice since it's been a week now. I did get my second Moderna vaccine on February 15 and Fulvestrant injections on Feb. 22. My issues started on Feb. 25. Oddly, right now as I'm typing this, my gut is much calmer. Yesterday was my worst day with diarrhea. 3/13/21 ER for back pain - transferred to second hospital - remains admitted there as of 3/16/21 History of Present Illness: Patient is a 68-year-old female with known metastatic ovarian cancer under active treatment since 2004, currently on fulvestrant after a massive debulking surgery by Dr. last July (2020). Patient presented to outlying emergency room with flank pain & transferred here with severe bilateral hydronephrosis on imaging. Patient had severe left flank pain about 2 weeks ago. Treated with tylenol, motrin, and heat and pain eventually dissipated. Then Tuesday and Wednesday pt did a lot of yard work and lifting. Thursday patient woke up with excruciating right flank pain. Nothing has made it better. Patient has tried ice, heat, tramadol Tylenol, Motrin, steroids and pain persists. Additionally patient having nausea and vomiting. She has started to have burning with urination. Pain is excruciating stabbing. Radiates to the groin. Patient has also started running fevers today. She feels pretty miserable. Also patient notes difficulty with her bowels since her last surgery. Prior to surgery she took Linzess every day. Since surgery it has been suggested she does not need this medication. Patient does note little to no notice when her bowels decide to move. Severe significant gas. Other times patient feels quite constipated. UA suggests possible infection with positive nitrites, 1+ leukocyte esterase and 3+ blood. WBC 2.1, Cr 1.0, K 3.0 CT scan with multiple abnormalities, but most notably severe bilateral hydronephrosis without obvious obstructing lesion. Multiple scattered nodular densities concerning for metastatic disease. Patient transferred for higher level of care and urology consultation.
68 2021-03-15 pallor within several minutes of receiving Moderna, pt c/o coughing spells and SOB, no angioedema or hives.... Read more
within several minutes of receiving Moderna, pt c/o coughing spells and SOB, no angioedema or hives. Self-adminstered albuterol neb she had brought with at 3:30. Some improvement, benadryl 50mg given at 3:38. Pt initially continued to improve and was monitored. At 3:48 writer entered the room to find pt bent over stating "I can't breath", was pale. Epipen administered. Within minutes pt had improved, breathing easier, lungs clear, there was never any oral swelling. EMS arrived and transported pt to ER. of note, pt was given red liquid benadryl as it was all we had; she stated she had a history of sensitivity to red dye but not anaphylaxis, just will "feel sick" the next day
68 2021-03-15 fainting, blood pressure increased Patient experienced faintness,rigors,weakness, diaphoresis, and c/o of neck and jaw pain. Blood pre... Read more
Patient experienced faintness,rigors,weakness, diaphoresis, and c/o of neck and jaw pain. Blood pressure was elevated with complaints of shortness of breath as well. Vaccine administered at 1:39 and adverse reaction at 1:45pm. Benedryl 50mg IM given at 2pm. Symptoms resolved about 2:45pm. Patient was discharged to home with family member. Patient declined EMS transport to ER. Patient encouraged to follow-up with PMP.
68 2021-03-15 fainting Shortly after receiving her Covid vaccination, patient complained of a weird taste, dizziness and f... Read more
Shortly after receiving her Covid vaccination, patient complained of a weird taste, dizziness and feeling faint. I monitored the patient closely, checked her vital signs and everything was normal. Medical history revealed patient has type 2 DM and HTN. I asked patient if she had taken her meds and eaten breakfast (time was 11:15am at this point). She said she took her meds but hadn't eaten breakfast. I bought her orange juice and a few snacks. In less than 5 minutes after eating/snacking. She mentioned that she was feeling remarkably better. I monitored her for 15 minutes more to make sure she was fully recovered. She was very grateful and felt at ease leaving the pharmacy. I will check on her later.
68 2021-03-16 heart rate increased, chest discomfort Fast heart rate (113 - possibly higher before I checked it): began about 24 hours after injection an... Read more
Fast heart rate (113 - possibly higher before I checked it): began about 24 hours after injection and continued for about 8 hours before gradually reducing to a less elevated (but still a bit high) level. Slightly elevated systolic blood pressure (138 - about 20 higher than my usual - may have been higher before I checked it): began about 24 hours after injection Weakness: began intensely about 24 hours after injection; has improved but continues to be noticeable four days after injection Chest tightness: began about 24 hours after injection; has improved but continues to be noticeable four days after injection Lip tingling: became noticeable four days after injection
68 2021-03-16 loss of consciousness Passed out; Sweats; Lightheaded; Fatigue; Chills; Nausea; Vomit; Headache; A spontaneous report was ... Read more
Passed out; Sweats; Lightheaded; Fatigue; Chills; Nausea; Vomit; Headache; A spontaneous report was received from a consumer concerning herself, a 68 year old female patient who experienced passed out/loss of consciousness, sweats/hyperhidrosis, lightheadedness/dizziness, fatigue/fatigue, chills/chills, nauseas/nausea, vomit/vomiting, headache/headache. The patient's medical history was not provided. Concomitant product use was not provided. The patient received her first of two planned doses of mRNA-1273 on unknown date for prophylaxis of Covid-19 infection. On 01-Mar-2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Batch number 014M20A) intramuscularly into her left arm for prophylaxis of Covid-19 infection. On 02-Mar-2021, the patient stated she "passed out", she also experienced sweats, lightheadedness, fatigue chills, nauseas, vomit, and headache. No other treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The events, passed out/loss of consciousness, sweats/hyperhidrosis, lightheadedness/dizziness, fatigue/fatigue, chills/chills, nauseas/nausea, vomit/vomiting, headache/headache.was considered unknown.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Fatigue, chills vomiting, headache and nausea are consistent with the known safety profile of the vaccine
68 2021-03-16 lightheadedness Confusion - vasovagal reaction. BP 131/62 (pulse 69), O2 sat 98%.
68 2021-03-17 chest discomfort Started with tired then freezing cold...dizziness and weakness...very thirsty...then all of a sudden... Read more
Started with tired then freezing cold...dizziness and weakness...very thirsty...then all of a sudden couldn't breathe felt like a ton of bricks on my chest...couldn't get a breath of air....tried to lie down but could only sit up...developed a 100.6 fever...the difficulty breathing went on all night...used both the albuterol and symbicort which helped a little bit ....but the pressure was still there...this lasted until Thursday morning....breathing better but still tired and thirsty...
68 2021-03-17 chest pain Second vaccine shot given March 7th. 25 hours later I expereinced headache, tiredness, fever, aches ... Read more
Second vaccine shot given March 7th. 25 hours later I expereinced headache, tiredness, fever, aches and chills. March 10th was a normal day. No symptoms; felt great, normal routine for the day. That night at 12:30 am I woke up with chest pain and shortness of breath. I was in extreme pain and felt like I couldn't breathe. My husband took me to the Emergency Room. Nitro and morphine administered. No relief. EKG, Chest X Ray, CT Scan with contrast, cardiac catheterization, Echo, and lots of bloodwork. I was in pain until 5:15 pm on the 11th. My primary doctor came and hospital switched morpine to toradol which provided some relief. I stayed overnight in hospital and was discharged at 6 pm on the 12th.
68 2021-03-17 nosebleed 01:15 am on 03/16/2021: Began with chills, muscle aches, headache, body temperature 95.7F. Rapidly... Read more
01:15 am on 03/16/2021: Began with chills, muscle aches, headache, body temperature 95.7F. Rapidly developed fever at highest 101.1F. The swing in body temperature occurred within 20 minutes. Continued . Temperature upon awakening at 08:15 am on 03/16/2021 was 99.1F. Occasional chills and low grade fever continued through that Tuesday. I mostly stayed in bed. Developed soreness and heat around the injection site. I slept through until 2:00 pm. Wednesday afternoon and had considerable dizziness on arising. At 3:00 pm on Wednesday, I had a sudden nosebleed, my first ever. Bleeding was under control in about 30 minutes. This was my first ever nosebleed. At night when retiring to bed my gums bled with brushing...unusual.
68 2021-03-17 pulse abnormal Person received Vaccine injection was ambulatory to observation area became lightheaded dizzy, sat i... Read more
Person received Vaccine injection was ambulatory to observation area became lightheaded dizzy, sat in chair skin pale cool diaphoretic. weak ,radial pulse, initial V/S B/P 64/43 HR 114 O2 Sat % 97 RM. air. Pt to stretcher supine color returned to pink warm dry HR decreased to 97 O2 Sat % 98 B/P remains 61/39. 911 called ambulance arrived reassessed person with care taken over and transferred to ED. Pt states to Ambulance personnel that she was not feeling well today prior to arrival for Vaccine.
68 2021-03-18 heart rate abnormal Moderna COVID-19 Vaccine EUA. Dose 2 Chills and Fever up to 102 orally starting about 6 hours after ... Read more
Moderna COVID-19 Vaccine EUA. Dose 2 Chills and Fever up to 102 orally starting about 6 hours after vaccine. Joint pain knees and neck, headache, lack of appetite, depression, rapid heart rate. Fever lasted about 2 days. Joint pain was severe the night after the vaccine but was gone by the morning. Headache lasted about a day and a half. Felt weak but may be from no appetite.
68 2021-03-18 loss of consciousness Fever (T101F); Passed out for 10 minutes; Felt sick; Arm swollen and big; Big rash on the area; Fel... Read more
Fever (T101F); Passed out for 10 minutes; Felt sick; Arm swollen and big; Big rash on the area; Felt like vomiting; A spontaneous report was received from a consumer concerning a 68 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm swollen and big rash on the area, felt sick (illness), felt like vomiting (nausea) , passed out for 10 minutes (loss of consciousness), and fever (pyrexia). The patient's medical history was not provided. No information of the concomitant medication was given. On Mar-01-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 batch no: 022M20A in the left arm for prophylaxis of COVID-19 infection. On Mar-02-2021, The patient experienced arm swollen and big, big rash on the area, felt sick, felt like vomiting, passed out for 10 minutes. On Mar-03-2021, The patient experienced fever(101F). No treatment information was given. The outcome of the events arm swollen and big rash on the area, felt sick (illness), felt like vomiting (nausea) , passed out for 10 minutes (loss of consciousness), and fever (pyrexia) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
68 2021-03-18 loss of consciousness Diagnosed with C. difficile.; Nasty abdominal cramps; Passing out; Lack of appetite; Diarrhea; Falli... Read more
Diagnosed with C. difficile.; Nasty abdominal cramps; Passing out; Lack of appetite; Diarrhea; Falling; Arm pain; A spontaneous report was received from a consumer concerning a 68 year old, female patient who developed severe stomach cramps, passed out, lack of appetite, falling and diarrhea. The patient's medical history was not provided. Concomitant product use included Tums (up to 2 tabs five times per day), Gas-X, Pepto, Probiotic (30 billion units) and clindamycin, all were used for an unknown indication. The patient received the first of two planned doses of mRNA-1273 (Batch number: 010M20A) on 27 Jan 2021. On 24 Feb 2021, approximately 5 hours prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. After the first shot of vaccine the patient reported no reactions other than mild arm pain. After the second dose of vaccine the patient had gastrointestinal distress. The patient had severe stomach cramps, she passed out while on the toilet, she fell in toilet and her husband helped to stabilize, lack of appetite and diarrhea. Patient had been instructed to adhere to a bland diet consisting of toast, rice, bananas, broth, and Pedialyte by her physician. She reported that she was hospitalized on 09 Mar 2021 and was released on 11 Mar 2021. She stated that she ended up being diagnosed with C. difficile. She stated the gastroenterologist did not believe the C. difficile was caused directly from the second dose in the series from Moderna's COVID-19 vaccination. Consumer reported that she was originally was taking a three days course of clindamycin which is a suspect for C. difficile. She was prescribed a 10 days course of vancomycin. Treatment for the event included Bland diet, Tums, Gas- X, Pepto, Probiotic. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The events, severe stomach cramps, passed out, lack of appetite, diarrhea, was considered resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
68 2021-03-20 blood glucose increased, loss of consciousness 3/14, 1 AM--awoke with fever, could not sleep for more than an hour or more at a time. Got up at 7 A... Read more
3/14, 1 AM--awoke with fever, could not sleep for more than an hour or more at a time. Got up at 7 AM and took a Tylenol and drank water. Extreme weakness for the rest of the day with chills, some body aches, a little nausea. 3/15, 7 AM--woke up after 9+ hours of sleep and felt great. Drank water, took the dog for a walk (about an hour). Returned to my house and was talking to a neighbor when I was overwhelmed with lightheadedness and nausea, told her I needed to sit down and suddenly passed out. Came to in about a minute, had a cut in my head from hitting the concrete and could not stand without feeling dizzy. An ambulance was called and I was transported to the local hospital. Was given fluids and anti-nausea medication in the ambulance.
68 2021-03-20 heart rate increased Cannot taste Sweet. Pure Sugar has no flavor! Had a fast heart rate for about an hour that started 4... Read more
Cannot taste Sweet. Pure Sugar has no flavor! Had a fast heart rate for about an hour that started 4 hours after injection. Also had a few sweats which were over in 8 hours.
68 2021-03-20 heart rate irregular, chest discomfort, palpitations 1st shot: Same day: aches and fogginess for 24 hours 2nd shot: Same day: aches, fogginess, fatigue,... Read more
1st shot: Same day: aches and fogginess for 24 hours 2nd shot: Same day: aches, fogginess, fatigue, and growing SOB, heaviness and tightness in chest, frighteningly forceful occasional heart beat, irregular heart rhythm over the next couple of weeks. Aches gone in 24 hours. Fogginess, fatigue. SOB, chest and heart symptoms significantly subsided 19 days after 2nd shot.
68 2021-03-20 hypotension Not requiring emergency care Concerned about second dose Irritation bronchial tube, pain and decreas... Read more
Not requiring emergency care Concerned about second dose Irritation bronchial tube, pain and decreased function joints of knees Sore throat, general nausea, unable to take deep breath, needing to sit to rest long term,heavy flu-like symptoms incontinence lasting 40 hours inability to use abdominal muscles to defecate lasting 40 hours Difficulty rising to standing position Extreme fatigue compounding that from having Covid in 04/20 which never cleared BP 100/70 for 40 hours (usual 135/78 on Amlodipine) No treatment/ contacted physician office
68 2021-03-21 anaemia I did not administer vaccine in my office, I was the provider she saw after seeing her PCP who wrote... Read more
I did not administer vaccine in my office, I was the provider she saw after seeing her PCP who wrote the adverse event off and was not worried about vaginal bleeding in a 68 woman.
68 2021-03-21 heart rate increased Became very tired and had to go to bed, flu like symptoms, pains, chills, and clammy with no fever, ... Read more
Became very tired and had to go to bed, flu like symptoms, pains, chills, and clammy with no fever, ice coldness going up and down arm. this lasted then a week later a rash developed at injection site, then the next day developed tinnitus and felt like a thousand bees in the head, and then heart beat went up to 107 when it's normally at 70BPM. Since then the tinnitus has continued and not gone away, can't sleep and very nervous. The doctor was called and we couldn't get an appointment until the 29th. very distraught at this time. Second dose has not been taken yes, she's a very petite person and weights 90 pounds.
68 2021-03-21 hypertension anxious, headache, dizziness, BP high, transfer to ED
68 2021-03-21 fast heart rate itching, tachycardia
68 2021-03-22 blood pressure increased, hypertension Light-headed, dizzy, weak - felt like legs would not hold me up, fluttery sensation in body, high bl... Read more
Light-headed, dizzy, weak - felt like legs would not hold me up, fluttery sensation in body, high blood pressure. 45 minute duration with gradual recovery. Mild pain at injection site, head and neck pain, fatigue -3 day duration.
68 2021-03-23 oxygen saturation decreased She first felt dizzy and light headed about 15-20 mins after shot. An hour later she used the bathro... Read more
She first felt dizzy and light headed about 15-20 mins after shot. An hour later she used the bathroom on herself and was disoriented. The ambulance was called, her oxygen levels were low and she was taken to the hospital. She has seizures at the hospital and she has been sedated ever since.
68 2021-03-23 pulmonary embolism, deep vein blood clot Developed right lower extremity DVT and pulmonary emboli after travel out of state where vaccine was... Read more
Developed right lower extremity DVT and pulmonary emboli after travel out of state where vaccine was administered. Presented to ED and diagnosed with VTE, placed on rivaroxaban and referred to hematologist.
68 2021-03-24 heart rate increased Within a couple minutes of the vaccination, pt reported "itching behind the ears", "then heart start... Read more
Within a couple minutes of the vaccination, pt reported "itching behind the ears", "then heart started beating quickly and felt panicked like I had to get out of the shot location and get mask off." She developed hives on the chest around midnight that evening. She took an allegra. Hives resolved in about 3.5 hrs. She had intermittent itchy head for a couple of days after the vaccine. She also had a sore arm where the injection was administered for a few days.
68 2021-03-25 hypotension COVID-19; low blood pressure; A spontaneous report was received from a consumer concerning a 68-yea... Read more
COVID-19; low blood pressure; A spontaneous report was received from a consumer concerning a 68-year-old, female patient who experienced COVID-19 and low blood pressure/hypotension. The patient's medical history included lupus. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unknown date. On an unknown date, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. The patient contracted COVID-19 since an unknown date. They also experienced low blood pressure. The laboratory investigations included blood pressure performed on an unknown date with result 91/50. The patient was hospitalized on an unknown date and was discharged after two days, date unknown. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events, COVID-19 and hypotension were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded except for the event of COVID-19. The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.
68 2021-03-25 blood clot I went into DKA, my left eye bled, my left arm has a blood clot I was in hospital 9 days and a reha... Read more
I went into DKA, my left eye bled, my left arm has a blood clot I was in hospital 9 days and a rehabilitation place for 11 days.
68 2021-03-26 blood glucose increased Shivering, shuffling of feet, trouble standing and walking, falling, fever, weakness, high blood sug... Read more
Shivering, shuffling of feet, trouble standing and walking, falling, fever, weakness, high blood sugar
68 2021-03-26 blood glucose increased Five days or more after the shot still feeling hot flashes and having gastrointestinal problems. Als... Read more
Five days or more after the shot still feeling hot flashes and having gastrointestinal problems. Also still having high glucose numbers
68 2021-03-26 chest pain Immediately after vaccine, burning in chest (esophagus or lungs?), lightheaded, flushed, sweaty, red... Read more
Immediately after vaccine, burning in chest (esophagus or lungs?), lightheaded, flushed, sweaty, red face. 7 days after vaccine (yesterday), 2 x 3 inch swollen knot in arm, red, itchy and hot.
68 2021-03-26 transient ischaemic attack Three days after vaccination my sister, suffered 2 Mini-strokes. She was taken to the hospital and ... Read more
Three days after vaccination my sister, suffered 2 Mini-strokes. She was taken to the hospital and is now in an Acute Rehabilitation Facility for one more week. She is unable to walk without assistance and has some speech and vision problems. Not sure is there is any connection with this and the vaccination, but just wanted to give the information in case.....
68 2021-03-27 blood pressure increased At 4pm patient states got facial drooping, increase in BP, and confusion
68 2021-03-28 blood glucose increased, palpitations Received call from patient today to cancel appt. Was seen by PCP today and advised not to take 2nd d... Read more
Received call from patient today to cancel appt. Was seen by PCP today and advised not to take 2nd dose due to development of symptoms after receiving 1st Moderna vaccine. Said heart began racing @24 hours after vaccination. Blood sugar elevated over 200 and has been under control. Described heart as "jello with a fly in it" Saw PCP today and he does not want her to have, thinks she is allergic to component in vaccine.
68 2021-03-28 blood glucose increased Per EMS, patient with complex medical history "weak and lethargic" post vaccine. She was alert enoug... Read more
Per EMS, patient with complex medical history "weak and lethargic" post vaccine. She was alert enough to decline transport the first time; she agreed to transport a few minutes later after speaking to EMS control. Vitals assessed by EMS: BP 144/42 (perhaps typo of 92); Blood glucose 450; O2 saturation 98%; heart rate 55. See chronic conditions section for list of existing conditions.
68 2021-03-28 chest pain For 24 hours: extreme fatigue, nausea, moderate joint pain, overall flu-like aches, slight chest pai... Read more
For 24 hours: extreme fatigue, nausea, moderate joint pain, overall flu-like aches, slight chest pain for a brief time, moderate headache. For 1st 12 hours: fever 103° For 2nd 12 hours: fever 101° All symptoms disappeared once fever went away.
68 2021-03-28 deep vein blood clot Pt reports having her 2nd covid vaccine on 3/5, and on 3/17 began to have significant lower leg pain... Read more
Pt reports having her 2nd covid vaccine on 3/5, and on 3/17 began to have significant lower leg pain, tenderness, and purpura. Pt was diagnosed with erythema nodosum.
68 2021-03-28 heart rate irregular 12 hours after the shot until 20 hours after the shot : fever up to 101.7; body aches; head ache; he... Read more
12 hours after the shot until 20 hours after the shot : fever up to 101.7; body aches; head ache; heart irregularities; fatigue. After the fever broke, and after drinking "pedilyte" ( for potassium and elecrolytes to help with irregular heart beats) just fatigue. Not further affects as of now ( 71 hours after shot ).
68 2021-03-28 loss of consciousness passed out on way to bathroom; Maybe it was a seizure; Feeling weak; Fever of 103,Lowest the fever c... Read more
passed out on way to bathroom; Maybe it was a seizure; Feeling weak; Fever of 103,Lowest the fever could get is 101; Diverticulitis attack; A spontaneous report was received from a consumer concerning a female patient of 68 years old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Diverticulitis attack, felt weak, passed out, seizure and Fever of 103. The patients medical history included sensitivity to medicines. No relevant Concomitant medications were reported. On 08 Mar 2021,prior to the onset of events, the patient received the first of two planned doses of mRNA-1273(Lot number: 011A21A) vaccine through unknown route for prophylaxis of COVID-19 infection. On 10 Mar 2021, at 1am, she woke up with a fever of 103. The highest was 103 and the lowest she could get it down to was 101. The patient passing out on way to bathroom at one point also and does not know how long she was out for. She believes she could have had a seizure. She also had a diverticulitis attack in this time period which she states being the worse attack and she felt pretty weak . Treatment for the event included Tylenol and used icepacks and was on a liquid diet. Action taken with the mRNA-1273 in response to the event was not provided. The fever resolved on 12 Mar 2021 while the diverticulitis attack and weakness resolved on 16 Mar 2021. The outcome were unknown for other events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
68 2021-03-29 loss of consciousness vomiting,diarrhea , headache , body ache , dizzyness , incoherent, passing out for hours at a time ... Read more
vomiting,diarrhea , headache , body ache , dizzyness , incoherent, passing out for hours at a time , weakness
68 2021-03-29 fainting Passed out at one time; Having COVID symptoms; Massive headache; A spontaneous report was received f... Read more
Passed out at one time; Having COVID symptoms; Massive headache; A spontaneous report was received from a consumer concerning a 68-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced massive headache, passed out at one time/syncope and having COVID symptoms. The patient's medical history was not reported. No relevant concomitant medications were not reported. On 26 Feb 2021, approximately two days prior to onset of the events, the patient received their dose of mRNA-1273 (batch number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Feb 2021, the patient had a massive headache. On an unknown date, the patient passed out at one time (medically significant event) and overall just having COVID symptoms. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events massive headache, passed out at one time and having COVID symptoms was not reported.; Reporter's Comments: This case concerns a 68-year-old female who experienced serious unexpected events of syncope along with nonserious events of unexpected COVID-19 and expected headache. Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
68 2021-03-30 fibrin d dimer increased, arrhythmia, atrial fibrillation, enlargement of the heart, fast heart rate, ejection fraction decreased Rapidly progressive dyspnea and fatigue, worse with even light exertion, at night and laying down.
68 2021-03-30 hypertension About 8 hours after the injection, I developed hives in my mouth causing one side of my face to swel... Read more
About 8 hours after the injection, I developed hives in my mouth causing one side of my face to swell. This lasted about 6 hours. I started running a fever about 12 hours after the injection and it continued for 2 full days, fluctuating between 98.9 and 100.4. In addition to the fever, I woke the morning after the injection with a slight headache, leg muscle pain, stopped up sinuses like a head cold, and no appetite. All of these lasted about 18 hours. There was a slight soreness at the injection sight the 1st night; but the soreness worsened the next day, moved down the arm muscle about a hand width below the injection site and became a hard and red feverish area the size of my palm. It lasted about 3 days.
68 2021-03-31 loss of consciousness I was knocked out; I was not able to get out of bed for two days; I was sore all over; Sore in arm w... Read more
I was knocked out; I was not able to get out of bed for two days; I was sore all over; Sore in arm where I got the injection; A spontaneous report was received from a consumer concerning a 68 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced was knocked out/loss of consciousness, was not able to get out of the bed for two days/movement disorder, sore in arm where got the injection/injection site pain and was sore all over/pain. The patient's medical history included Covid-19 about a year ago. Concomitant product use was not provided by the reporter. On 01 Mar 2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 029A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unspecified date, approximately 12 hours after the vaccination patient experienced soreness all over and pain in arm where she got the vaccination. Later patient lost her consciousness and was not able to get out of bed for two days. Patient expressed these side effects are far worse than when getting the disease (Covid-19). Treated with Ibuprofen and it didn't help. No relevant laboratory details were included. Action taken with the drug in response to the events were not reported. The outcomes of the events, was knocked out/loss of consciousness, was not able to get out of the bed for two days/movement disorder and was sore all over/pain were considered as unknown. The outcome of the event, sore in arm where got the injection/injection site pain was considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
68 2021-03-31 palpitations, blood pressure increased Suddenly felt very ill 20 min after getting vaccine. Shaking, heart racing, difficulty breathing,diz... Read more
Suddenly felt very ill 20 min after getting vaccine. Shaking, heart racing, difficulty breathing,dizzy, weak, elevated blood pressure, frequent urination
68 2021-04-02 chest discomfort, chest pain Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Sys... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: right chest sensations, felt like she had anesthia-Medium, Systemic: Headache-Medium, Systemic: Tinnitus-Medium, Systemic: Weakness-Medium
68 2021-04-04 excessive bleeding Woke up in the middle of the night; Pain in the legs; Blood on toilet paper when wiped; Fever; Joint... Read more
Woke up in the middle of the night; Pain in the legs; Blood on toilet paper when wiped; Fever; Joint pain; Muscle pain; Uncomfortable; Chills/Shivering; Pain on the Injection Site; A spontaneous report was received from a consumer concerning a 68-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, discomfort, injection site pain, fever/pyrexia, sleep disturbance/sleep disorder ,bleeding/haemorrhage, joint pain/arthralgia, myalgia/muscle pain, pain in extremity/pain in leg. The patient's medical history was as cloudy urine prior to vaccination .No Concomitant medications were reported. On 04 Feb 2021,the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in an unknown location for prophylaxis of COVID-19 infection. On 04 Feb 2021 ,night after receiving the vaccine the patient developed chills, was uncomfortable and had little pain in the injection site. On 06 Feb 2021 in the middle of night the patient started shivering, chills and fever to a temperature of 101.4.The patient also noticed bleeding when she went to bathroom. But there was no pain or burning sensation on urination. The patient also experienced muscle pain, joint pain and leg pain as well. Event Blood on toilet paper when wiped was considered medically significant. Action taken with mRNA-1273 in response to the events was not reported. The events, chill, uncomfortable and little pain on injection site were considered recovered on the days 05 Feb 2021.And the events fever bleeding ,muscle pain, joint pain and leg pain were considered unknown; Reporter's Comments: This case concerns a 45 Y/O F with a serious unexpected hemorrhage and nonserious unexpected discomfort, sleep disorder, pain in extremity, and expected vaccination site pain, pyrexia, chills, arthralgia, myalgia. Event onset the same days as first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
68 2021-04-04 loss of consciousness Upon waking at about 2 am in the morning, my left arm was partially paralized, pins and needs in my ... Read more
Upon waking at about 2 am in the morning, my left arm was partially paralized, pins and needs in my fingers. I went to go to the bathroom and blacked out on my way back to the bedroom and came too sitting on my file floor, very disoriented and my clothese wee drenched in cold sweat so much so that I needed to change. For the next 3 days I experienced fatigue, vertigo and brain fog. When I had COVID in April of 2020 and didn't experience any symptoms like this. After four days, I continued to have aches in my legs for another 5 days and my fatigue lifted gradually.
68 2021-04-04 palpitations STINGING TONGUE 45 MINUTES AFTER INJECTION; CLIENT STATED SHE WAITED 45 MINUTES AFTER VACCINE ADMINI... Read more
STINGING TONGUE 45 MINUTES AFTER INJECTION; CLIENT STATED SHE WAITED 45 MINUTES AFTER VACCINE ADMINISTRATION THEN DROVE HOME, ON THE WAY HOME SHE EXPERIENCED RACING HEART, STRATCHY THROAT, DIZZINESS, AND METALLIC TASTE IN MOUTH; SHE WENT STRAIGHT TO DR OFFICE WHO ADVISED SHE RETURN HOME AND TAKE BENADRYL. SHE STATES SHE TOOK BENADRYL EVERY 8 HOURS AND THE ADVERSE EFFECTS LASTED 4 DAYS, TODAY WAS DAY 5 AND SHE IS FELLING BETTER, ALSO EXPERIENCED A SWOLLEN ARM AND COULD NOT SLEEP IN HER BED AND A LARGE BRUISE ON HER ARM.
68 2021-04-05 nosebleed Bloody nose three days in a row. April 4, 5, 6, 2021. Chills, fever, aches and pains, tired. Adminis... Read more
Bloody nose three days in a row. April 4, 5, 6, 2021. Chills, fever, aches and pains, tired. Administered for 2nd COVID vaccination. Administration was at supermarket
68 2021-04-05 loss of consciousness Achy, light headed @ 3 a.m....went to kitchen to take Tylenol , took it & then passed out on the ki... Read more
Achy, light headed @ 3 a.m....went to kitchen to take Tylenol , took it & then passed out on the kitchen floor. I landed on my bottom & then I was aware of what happened. Only happened once, & was feeling somewhat better by around 11. Husband was concerned, so this is why I'm sending this your was
68 2021-04-05 palpitations I am a highly sensitive person. After the first injection my blood pressure was much higher than no... Read more
I am a highly sensitive person. After the first injection my blood pressure was much higher than normal at a routine physical with my doctor. The second injection caused me to experience extremely elevated anxiety, with heart palpitations, digestive problems, and panic. I've used rest, fluids, ginger tea and sleepy time tea to treat. Now, on day 5, the symptoms have diminished but not disappeared.
68 2021-04-05 fast heart rate, chest pain, lightheadedness Patient developed cold like symptoms on 3/10- nasal congestion, cough that progressed to left lung ... Read more
Patient developed cold like symptoms on 3/10- nasal congestion, cough that progressed to left lung ache/pressure, cough worsened, chest congestion, sore throat. On day 3/17 and 3/18 patient became SOB, malaise, chills/sweats, achy, tired, nausea, emesis, anorexia, "heart tightness' with ambulation, presyncope. Right leg started to feel tight and painful behind the knee, tachycardia.
68 2021-04-06 atrial fibrillation, fast heart rate Patient admitted for observation to Hospital ER after presenting with A. fib with RVR and tachycardi... Read more
Patient admitted for observation to Hospital ER after presenting with A. fib with RVR and tachycardia. Patient monitored for less than 24 hours, rate control and discharged home with medication updates and to follow up in clinic.
68 2021-04-07 chest pain 12 hours after taking the second vax. her arm was swollen, red and painful. she some chills, nause... Read more
12 hours after taking the second vax. her arm was swollen, red and painful. she some chills, nausea and fever that lasted about 48 hours. Weeks later these symptoms came back and were more extreme. 4/5/2021 pt has SOB w/ slight exertion. she developed numbness in her left side of her face including her ear down to her teeth. 4/6/2021 she started violently shaking with chills. her fever was about 102 and she had a severe headache. She had nausea w/ dry heaving. She had chest pain from reflux. She could stand but not walk. Ambulance was called and she was taken to ER, She had CT, Chest XRAY, EKG, Covid TESTs, Antibodies blood test. Lab work. O2 level was 98%. All test were normal/negative. She was discharged to go home. On 4/8/2021 her temp was 104. She had brain fog. She went back to same ER. They did the same test. This time the chest x-ray shows small right lower lobe infiltrate. Pt had no cough. Her white blood count was normal and was told she had viral pneumonia. She never had any type of symptom normal to having pneumonia. She was put on antibiotics and something for nausea. Her fever and headache finally broke after about 5 days. She had no strength and was basically laid up sick for almost a month. She feels like she had a bad reaction to the covid vax since she had a viral lung infection with typical pneumonia symptoms.
68 2021-04-07 chest pain Chest pain; Dizzy-headed; Runny nose; Slight headache; This spontaneous case was reported by a consu... Read more
Chest pain; Dizzy-headed; Runny nose; Slight headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain), DIZZINESS (Dizzy-headed), RHINORRHOEA (Runny nose) and HEADACHE (Slight headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Lupus syndrome and Heart disorder (slight heart condition.). Concomitant products included CLONAZEPAM (KLONOPIN) for an unknown indication. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization), DIZZINESS (Dizzy-headed) (seriousness criterion hospitalization), RHINORRHOEA (Runny nose) (seriousness criterion hospitalization) and HEADACHE (Slight headache) (seriousness criterion hospitalization). The patient was hospitalized on sometime in February 2021 due to CHEST PAIN, DIZZINESS, HEADACHE and RHINORRHOEA. At the time of the report, CHEST PAIN (Chest pain), DIZZINESS (Dizzy-headed), RHINORRHOEA (Runny nose) and HEADACHE (Slight headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-060612 (Patient Link).
68 2021-04-07 heart rate increased Arm painful and swollen; nausea; weakness; slightly increased heart rate; headache
68 2021-04-07 palpitations Severe headache started about 3pm and lasted all night, better the next day lasted until 7pm. Both h... Read more
Severe headache started about 3pm and lasted all night, better the next day lasted until 7pm. Both hips and back hurting most of the night. Pounding heart. Took Tylenol - hardly touched the pain.
68 2021-04-08 fainting woke up feeling very groggy, double vision, woozy, weak. Tried to fill coffee pot but no strength, w... Read more
woke up feeling very groggy, double vision, woozy, weak. Tried to fill coffee pot but no strength, went to sit at kitchen table. Tried to stand and collapsed on floor. Husband called 911. Took blood pressure, glucose reading and EKG. All were OK. Told me to advise my doctor. Went to him next day and he said based on symptoms it sounded like severe hydration. He was not sure if it was attributed to the vaccine.
68 2021-04-09 blood pressure increased TINNITUS IN LEFT EAR. EXTREME DIZZINESS ON DAY 5. ONGOING VERTIGO SYMPTOMS INTO THIRD WEEK SINCE SEC... Read more
TINNITUS IN LEFT EAR. EXTREME DIZZINESS ON DAY 5. ONGOING VERTIGO SYMPTOMS INTO THIRD WEEK SINCE SECOND SHOT. HEADACHE AND FATIGUE. ELEVATED BLOOD PRESSURE. 150 OVER 90. DONT TAKE BP MEDS.
68 2021-04-09 cerebrovascular accident Stroke
68 2021-04-09 cerebrovascular accident CVA, Cerebral Vascular Accident
68 2021-04-09 chest discomfort, heart rate increased fatigue/ sever headaches / upset stomach / heavy feeling in my chest/ fast heart beat/ cough/ ... Read more
fatigue/ sever headaches / upset stomach / heavy feeling in my chest/ fast heart beat/ cough/ sinuse congestion/ swelling of eyes and draining/ blood shot eyes/ joints sore/ ears closed
68 2021-04-10 chest discomfort Upon awakening: severe aching all over body similar to flu; a feeling of deep lethargy, mental fog, ... Read more
Upon awakening: severe aching all over body similar to flu; a feeling of deep lethargy, mental fog, and difficulty in moving and rising from bed due to a feeling of heaviness. Left upper arm VERY stiff, painful and difficult to raise, although I had applied an ice gel pack to it on and off on the day of receiving the injection. No redness or swelling. Soles of both feet burning, very painful to walk. Occasional twinges of very sharp stabbing pain where big toe adjoins right foot, about once or twice per hour, pains lasting about 20 seconds each. Unusual urinary urgency and frequency, with difficulty holding it back before getting to the bathroom. Uncomfortable feeling of fullness and burning in left breast.... Due mental fog and some dizziness, and pain with walking and moving about, I was unable to do most normal daily activities or work at my job. I spent the whole day in bed and tried to sleep as much as possible. Also applied a heating pad intermittently to left upper arm to help with pain. All symptoms worsened throughout the day and evening. After dozing in bed throughout the day, I fell soundly asleep between 7:00 and 7:30 PM on April 9 with all symptoms still fully present. After sleeping soundly for approximately 6 hours, I awakened at 1:00 AM on April 10 and immediately realized that every symptom described here had disappeared. There was absolutely no trace of any of the symptoms, not even any residual soreness left in my arm. I felt perfectly well and strong and normal and that has continued. The only strange thing was that when I awakened at 1:00 AM on April 10 feeling well, even though I was perfectly cool upon awakening and had also not registered ANY fever when taking my temperature throughout the whole day of April 9, my entire body was drenched with perspiration upon awakening, including my hair, which was dripping wet, comparable to what might be experienced after a high fever.
68 2021-04-11 arrhythmia 24 hours post shot fever chills aches/pains treated with Tylenol, resolved after 24 hours. 48 hours ... Read more
24 hours post shot fever chills aches/pains treated with Tylenol, resolved after 24 hours. 48 hours post-shot, developed heart arrhythmia that has been sporadic since onset.
68 2021-04-11 platelet count decreased Severe bruising to hands and arms when handling books. Skin VERY black and blue for 7 to 10 days, t... Read more
Severe bruising to hands and arms when handling books. Skin VERY black and blue for 7 to 10 days, then went away. Possible it could be side effect of PRRT, as I had a little bit of bruising immediately after my 1st and 3rd PRRT treatments, but they were MUCH milder and took at least 4 weeks to go away. This time it was SEVERE bruising and happened 6 weeks after PRRT but only 4 weeks after COVID vaccine. And went away fairly quickly.
68 2021-04-12 blood glucose increased Patient is a 68-year-old female with a past medical history of HTN, HLD, hypothyroidism, diabetes, n... Read more
Patient is a 68-year-old female with a past medical history of HTN, HLD, hypothyroidism, diabetes, neuropathy, CAD presented to the ED with complaints of altered mental status. Her last known normal was yesterday morning around 10 am. It was reported that patient was watching TV yesterday evening, trying to speak with her relative, had some trouble getting her words out. She states that she did not feel well, had dizziness, called her husband, did not remember anything after that what happened. As per EMS, her blood sugar was 152, gave D10 en route to ED, improved mental status slightly. Currently she is alert and oriented x 3. Denies any complaints. She had headache earlier, resolved currently. CT of head, MRI brain diffusion weighted shows no acute abnormalities.
68 2021-04-12 chest pain chest pain; dizzy-headed; runny nose; slight headache; This spontaneous case was reported by a consu... Read more
chest pain; dizzy-headed; runny nose; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart disorder and Lupus erythematosus. Concomitant products included CLONAZEPAM (KLONOPIN) for an unknown indication. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization), DIZZINESS (dizzy-headed), RHINORRHOEA (runny nose) and HEADACHE (slight headache). At the time of the report, CHEST PAIN (chest pain), DIZZINESS (dizzy-headed), RHINORRHOEA (runny nose) and HEADACHE (slight headache) outcome was unknown. Concomitant product included heart medication. Treatment information included Tylenol. This case was linked to MOD-2021-060644 (Patient Link). Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
68 2021-04-12 deep vein blood clot Developed Left lower extremity edema, US showed extensive DVT
68 2021-04-12 heart attack Heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) an... Read more
Heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were reported. No treatment information was provided
68 2021-04-12 oxygen saturation decreased, chest discomfort On day 9: slight itching at injection site On day 10: severe pain, especially lower back ... Read more
On day 9: slight itching at injection site On day 10: severe pain, especially lower back Continuous head shaking Feeling of chest compression, pressure Difficulty taking a deep breath Rapid pulse (90s and 100+ at rest) Decreased oxygen level (below 90%, 94% at highest) Severe fatigue Explosive diarrhea Increased edema, especially hands, abdomen, and feet Days 11-12: Same symptoms but less severe Day 13: Most symptoms gone except back pain and fatigue Injection site warm for first time Day 14: All symptoms gone except fatigue
68 2021-04-13 cardiac arrest Death
68 2021-04-13 cerebrovascular accident On the morning February 22nd I was outside with my family in our backyard. I was checking our plant ... Read more
On the morning February 22nd I was outside with my family in our backyard. I was checking our plant when I started to feel that I needed to sit down. By the time I sat down, I realized I had no feeling or use from the left side of my body including my face. I also had trouble communicating. Could not form complete sentences. The entire left side of my face was drooping. At that moment my husband immediately called 911. I was taken to the hospital by ambulance where i was immediately treated and diagnosed with a stroke. They administered TPA. I spent 3 days in the ICU. I have since been treated with blood pressure medication, blood thinners and statins.
68 2021-04-13 hypertension, chest pain, pulmonary embolism, palpitations Bad chest pains, palpitations and high blood pressure. Ct scan found two small clots (pulmonary embo... Read more
Bad chest pains, palpitations and high blood pressure. Ct scan found two small clots (pulmonary embolism)
68 2021-04-13 heart attack, blood glucose increased Resident with nausea, vomiting, confusion, increased blood sugars, falling, tremor. Out to ED and tr... Read more
Resident with nausea, vomiting, confusion, increased blood sugars, falling, tremor. Out to ED and transferred to hospital. Found to have an MI and a brain abscess.
68 2021-04-13 platelet count decreased, low platelet count 68YF Small bowel obstruction within 1 week of vaccine Patient had incarcerated incisional hernia wit... Read more
68YF Small bowel obstruction within 1 week of vaccine Patient had incarcerated incisional hernia with SBO, preserved bowel on March 19 2021. Patient with alcoholic cirrhosis who presented with abdominal pain, nausea, and vomiting. She was found to have a small bowel obstruction and an umbilical hernia. She had electrolyte derangements including hypokalemia and AKI and was admitted to hospitalist service with surgery consulting. She improved with NG tube decompression, IV fluid resuscitation, and electrolyte repletion. On 3/19 she underwent umbilical hernia repair and was found to have an incarcerated umbilical hernia. On day of discharge she tolerated advancement to regular diet. Her AKI and hypokalemia resolved. She does have chronic thrombocytopenia due to her cirrhosis, with last available baseline platelet count in the 50s. She did not have any significant bleeding postoperatively. She did not have any signs of decompensation of her cirrhosis. MELD Na is 13, with less than 2% 90-day mortality. Patient drinks 1-2 times a month now and did not have any signs of alcohol withdrawal. CT abdomen and pelvis showed a right lower lung nodule at the base. This should be monitored as an outpatient. She was discharged to home in stable condition. Upon 4/13/21 Ambulatory Clinic visit: Patient is recovering well from surgery.
68 2021-04-14 blood glucose increased Upon administering second dose on left deltoid, patient became non responsive unable to hold her hea... Read more
Upon administering second dose on left deltoid, patient became non responsive unable to hold her head with tremors. Called local R.N stat. for further assessment. Checked vital signs at 11:46a.m the following was observed: O2 sat 100% , pulse 88, BP unable register at the time. At 11:47a.m Epi 0.3mg was given IM right thigh. by doctor orders. At 11:48am 911 was called. And O2 15L given via mask was initiated. And patient continued to struggle breathing and following simple commands. At 11:49a.m BP 217/81, HR 78, O2 sat 100% via mask; 11:52a.m O2 15L 100% via mask; 11:53a.m redness all over chest area and bilateral extremities; 11:55a.m paramedics arrived, BP 117/93, P85, O2 100% via mask; 11:59a.m Blood sugar 130; 12:01p.m Vital Signs, BP 179/83, P71, O2 98% Room air; 12:04 pm Patient was taken, location undetermined by paramedics.
68 2021-04-14 coughing up blood Patient reports coughing up small amounts of blood between 10 & 24 hours post-vaccination. The pati... Read more
Patient reports coughing up small amounts of blood between 10 & 24 hours post-vaccination. The patient reports that the issue was not present prior to vaccination & resolved after the 24 hour period. She did not seek further medical treatment at the time & did not report the reaction to the pharmacy until the time of her second dose of the vaccine. The patient did receive the second vaccine dose & has been instructed to report any issues to the pharmacy promptly.
68 2021-04-14 pulmonary embolism pulmonary embolus which occurred 3 weeks after her first moderna covid vaccine
68 2021-04-15 chest pain Patient reported pinpoint pain to chest at 1538. VS at 1540 BP 143/81 pulse 79 pulse 98%. Patient de... Read more
Patient reported pinpoint pain to chest at 1538. VS at 1540 BP 143/81 pulse 79 pulse 98%. Patient denied any symptoms of shortness of breath, jaw pain, and throat tightness. At 1540 patient signed
68 2021-04-15 pulmonary embolism Patient received second Modern COVID vaccine on 3/13. On 3/27 she developed shortness of breath. She... Read more
Patient received second Modern COVID vaccine on 3/13. On 3/27 she developed shortness of breath. She presented to her local ED and was found to have a large saddle pulmonary embolism. She underwent thrombectomy with IR x2 and was transferred to Medical Center for surgical pulmonary thromboendarterectomy.
68 2021-04-18 nosebleed Nausea, vomiting, diarrhea, severe trembling, headache, fever, swollen glands, swelling in eyes, lip... Read more
Nausea, vomiting, diarrhea, severe trembling, headache, fever, swollen glands, swelling in eyes, lips, tongue, uglia. Bloody nose. Swelling and itchy at vaccine sight and still swollen on 4/19/2021. Pressure in ears and head.
68 2021-04-19 atrial fibrillation Pt tested COVID positive on 3/24, less than 24 hrs post-vaccination #1. Pt reported no associated C... Read more
Pt tested COVID positive on 3/24, less than 24 hrs post-vaccination #1. Pt reported no associated COVID symptoms. Presented to hospital w/ weakness r/t Afib (longtime diagnoses).
68 2021-04-19 coughing up blood Woke up at 8am with the following reaction: coughing up blood, extreme nausea, very unsteady gait, s... Read more
Woke up at 8am with the following reaction: coughing up blood, extreme nausea, very unsteady gait, severe headache, tired
68 2021-04-19 pulmonary embolism Patient had lap chole 6 weeks after second Moderna shot and developed multisegmental PE 2 days after... Read more
Patient had lap chole 6 weeks after second Moderna shot and developed multisegmental PE 2 days afterwards. No known clotting issues.
68 2021-04-19 fainting Pt was feeling nervous and felt lightheaded and fainted and was still conscious but wanted to take t... Read more
Pt was feeling nervous and felt lightheaded and fainted and was still conscious but wanted to take the ambulance to be safe
68 2021-04-21 lightheadedness 7 days following 2nd Covid 19 vaccination, I had hives on the upper arm receiving the injection and ... Read more
7 days following 2nd Covid 19 vaccination, I had hives on the upper arm receiving the injection and spreading across the shoulders to the right upper arm. Hives were itchy for about a week, then went away after about 2 weeks. Only treatment was body lotion. 6 weeks and 1 day after 2nd vaccination experience near syncope. This occurred again 10 days later. Went to E.R. after 2nd occasssion. No clear reason found. Heart halter monitoring to follow, although vasovagal reflex a possibility.
68 2021-04-22 anaemia, pulmonary embolism, haemoglobin decreased Vaccine 3/15 (2nd dose) By 3/19 Began having significant shortness of breath, which progressed to b... Read more
Vaccine 3/15 (2nd dose) By 3/19 Began having significant shortness of breath, which progressed to being unable to walk even short distances . Multiple telehealth visits and message exchanges with primary care. Diagnosed with dyspnea and fatigue. Blood tests: 3/30 by 4/1 was sent for echocardiogram and chest xray from which initial diagnosis of pulmonary hypertension and right ventricle failure, and anemia. 4/6 could not move myself from house to car, had to get wheelchair to get to a doctor appointment (primary care wanted me to see a cardiologist). Cardiologist sent me straight to a hospital. Cat Scan showed mulitple pulmonary emboli in both lungs. Procedure was done (cath sent up through lungs, u
68 2021-04-22 palpitations fever; palpitations; heart disease, unspecified; allergy; asthma; dizzy; wrong injection technique; ... Read more
fever; palpitations; heart disease, unspecified; allergy; asthma; dizzy; wrong injection technique; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (palpitations) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for solution for injection for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 17-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong injection technique). On an unknown date, the patient experienced PALPITATIONS (palpitations) (seriousness criterion hospitalization prolonged), PYREXIA (fever) (seriousness criterion hospitalization), CARDIAC DISORDER (heart disease, unspecified), HYPERSENSITIVITY (allergy), ASTHMA (asthma) and DIZZINESS (dizzy). At the time of the report, PALPITATIONS (palpitations), PYREXIA (fever), CARDIAC DISORDER (heart disease, unspecified), HYPERSENSITIVITY (allergy), ASTHMA (asthma) and DIZZINESS (dizzy) outcome was unknown and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong injection technique) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 104 °F (High) 104 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. The patient received Covid-19 vaccine the same day as she did her first Humira (adalimumab) injection. The patient reported that they told her at the hospital that the symptoms were due to the Covid-19 vaccine. Treatment medication included Benadryl (diphenhydramine). Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
68 2021-04-23 loss of consciousness Passed out; she does not remember passing out; did not wake up till 3 in the afternoon that day; she... Read more
Passed out; she does not remember passing out; did not wake up till 3 in the afternoon that day; she was nauseous and in the morning when she got up she was extremely nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), AMNESIA (she does not remember passing out), SOMNOLENCE (did not wake up till 3 in the afternoon that day) and NAUSEA (she was nauseous and in the morning when she got up she was extremely nauseous). On 12-Mar-2021, LOSS OF CONSCIOUSNESS (Passed out), AMNESIA (she does not remember passing out), SOMNOLENCE (did not wake up till 3 in the afternoon that day) and NAUSEA (she was nauseous and in the morning when she got up she was extremely nauseous) had resolved. Concomitant medications were not provided. The patient did not remember passing out but found herself on the bathroom floor. Treatment information included bismuth subsalicylate. This case was linked to MOD-2021-081743 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
68 2021-04-24 fainting I had just taken a Tylenol to prevent any temp, muscle aches or chills. I felt like I was going to f... Read more
I had just taken a Tylenol to prevent any temp, muscle aches or chills. I felt like I was going to faint and before I could sit down, I fainted hitting the zygomatic arch of my face. Later that day I went to the hospital for CT scan to insure I had not broken anything. I was diagnosed with a medial blowout fracture of the right eye. Also followed up three days later at another health facility to insure there was no damage to the eye itself.
68 2021-04-26 cerebrovascular accident Within a few weeks after receiving first COVID injection patient became experiencing memory issues. ... Read more
Within a few weeks after receiving first COVID injection patient became experiencing memory issues. Workup has led to showing a temporal lobe stroke. Her symptoms include difficulty with memory. Impaired speech, knowing what she wants to say but words coming out wrong. Mild emotional issues. Mild aggression. Physically intact.
68 2021-04-26 haemoglobin decreased, brain sinus blood clot Moderna COVID-19 Vaccine EUA: patient with relapsed AML and right upper extremity deep vein thrombos... Read more
Moderna COVID-19 Vaccine EUA: patient with relapsed AML and right upper extremity deep vein thrombosis (DVT) presented to clinic with headache and found to have subdural hematomas and a cerebral venous sinus thrombosis of unclear acuity. Patient admitted for management of AML, subdural hematomas, and upper extremity DVT. Discharged home improved and medically stable.
68 2021-04-26 heart rate increased cellulitis; Sepsis; Elevated heart rate; Rash from the waist down on left side of body; chills; Feve... Read more
cellulitis; Sepsis; Elevated heart rate; Rash from the waist down on left side of body; chills; Fever; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis) and SEPSIS (Sepsis) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart rate increased (elevated heartrate). On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (Fever). On 15-Apr-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion hospitalization), SEPSIS (Sepsis) (seriousness criterion hospitalization) and RASH (Rash from the waist down on left side of body). On an unknown date, the patient experienced HEART RATE INCREASED (Elevated heart rate). The patient was hospitalized from sometime in April 2021 to sometime in April 2021 due to CELLULITIS and SEPSIS. At the time of the report, CELLULITIS (cellulitis), SEPSIS (Sepsis), HEART RATE INCREASED (Elevated heart rate), RASH (Rash from the waist down on left side of body), CHILLS (chills) and PYREXIA (Fever) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Heart rate: 132 (High) 132 beats per minute. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. She was admitted to the hospital and hospitalized for four days. She was diagnosed with cellulitis and sepsis. She was discharged home from the hospital with Augmentin (Amoxicillin / Clavulanic acid) for 10 days. Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded. However, Further information has been requested This case was linked to MODERNATX, INC.-MOD-2021-081503~, MODERNATX, INC.-MOD-2021-081439, MODERNATX, INC.-MOD-2021-081647 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded. However, Further information has been requested MODERNATX, INC.-MOD-2021-081503 :Fourth patient-Same reporter MODERNATX, INC.-MOD-2021-081439:First patient-Same reporter US-MODERNATX, INC.-MOD-2021-081647:Third patient-Same reporter
68 2021-04-26 hypertension High BP . CHECKED AT 6:55 AM 184/90 PULSE 80 CHECKED AT 7:00 AM 176/91 PULSE 76 CHECKED AT 7:11 AM 1... Read more
High BP . CHECKED AT 6:55 AM 184/90 PULSE 80 CHECKED AT 7:00 AM 176/91 PULSE 76 CHECKED AT 7:11 AM 170/95 PULSE 71 Customer also complained of getting itchy around the chest and throat area, I administered 10 ml of liquid Benadryl at 6:57 am
68 2021-04-26 pulmonary embolism multiple pulmonary emboli; could barely breath; fatigue; This spontaneous case was reported by a con... Read more
multiple pulmonary emboli; could barely breath; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (multiple pulmonary emboli) and DYSPNOEA (could barely breath) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062G20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Gallbladder removal on 25-Mar-2021. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (fatigue). On 27-Mar-2021, the patient experienced PULMONARY EMBOLISM (multiple pulmonary emboli) (seriousness criteria hospitalization prolonged, medically significant and life threatening) and DYSPNOEA (could barely breath) (seriousness criteria hospitalization prolonged, medically significant and life threatening). The patient was hospitalized for 3 days due to DYSPNOEA and PULMONARY EMBOLISM. On 13-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, PULMONARY EMBOLISM (multiple pulmonary emboli) and DYSPNOEA (could barely breath) outcome was unknown. The doctors believed that her diagnosis was not a common side effect from the surgery and believed that the vaccine contributed to the diagnosis. She was treated with apixaban, omeprazole and aspirin 81mg (once daily). The patient is scheduled to visit a hematologist after 6 months. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested This case was linked to MOD-2021-081407 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested MOD-2021-081407:Crosslinked case; Dose 1
68 2021-04-27 chest pain, pulmonary embolism She received her Moderna COVID vaccine on 02/26/201 which was a Friday, then on Monday and Tuesday p... Read more
She received her Moderna COVID vaccine on 02/26/201 which was a Friday, then on Monday and Tuesday patient had decreased appetite and felt miserable. Then on 03/08/2021 she started having chest pain that made her go to the ER. She was then found to have a multisegmental pulmonary embolism
68 2021-04-28 fibrin d dimer increased 24 hours after receipt of first Moderna vaccine dose patient developed progressive weakness and decr... Read more
24 hours after receipt of first Moderna vaccine dose patient developed progressive weakness and decreased responsiveness. She presented to the ER when was no longer able to walk independently. She complains of pain all over and shortness of breath. Her temperature was 103F. D-dimer+ and CT scan revealed multiple pulmonary emboli. She remains hospitalized.
68 2021-04-28 blood clot Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMB... Read more
Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 038K20A) for COVID-19 vaccination. No Medical History information was reported. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown. Not Provided No concomitant medications were reported. The patient had no problems after her second dose. Treatment information was not provided. Action taken with mRNA-1273 in response to events was not applicable. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
68 2021-04-29 pulse abnormal She presented for pain to her right arm. She notes Monday night (3/29/21) she couldn't sleep well, ... Read more
She presented for pain to her right arm. She notes Monday night (3/29/21) she couldn't sleep well, so she decided to lay on her right side, with her arm up and tucked beneath the pillow. She woke up about 1-1.5 hours later with a "Charlie horse" in her bicep area, pain was so intense that she was crying/in tears. Notes that her right hand has been colder than her left and with numbness since Monday. Use of the right arm causes pain, such as brushing her hair. She does have DDD, and notes some pain/issues with her right shoulder - so she's wondering if she has a pinched nerve. At this time she is having some numbing pain near the right side of her neck. She received COVID vaccine on 3/15/21 according to immunization registry.
68 2021-04-30 blood pressure increased Tinnitus noted three days post immunization. High pitched constant tone, both ears. First thought re... Read more
Tinnitus noted three days post immunization. High pitched constant tone, both ears. First thought related to BP elevation 150/90, however no change in tinnitus with BP treatment.
68 2021-04-30 chest discomfort 1-At about 1 you post administration: Chest tightness, sneezing. Felt systemic "weird" -not well. T... Read more
1-At about 1 you post administration: Chest tightness, sneezing. Felt systemic "weird" -not well. Treatment: Ventolin (2-puffs), 50 mg Benadryl (oral). Resolved in 24 hours 2-Day 1-2: Mild injection site pain. No treatment. Days 3-7: pain migrated from injection site down left arm and into upper shoulder. not positional or movement related - described as an ache like bone pain and disputes sleep. Treatment; Arthritis Strength Tylenol, local area massage, heat.
68 2021-04-30 chest pain Edema, swelling and pain in arm Fatigue. Body aches. Runny nose Chills Fever Cough. Trouble breathin... Read more
Edema, swelling and pain in arm Fatigue. Body aches. Runny nose Chills Fever Cough. Trouble breathing chest pain on deep breath
68 2021-04-30 loss of consciousness Passed out, blacked out, landed flat on her face, hospitalized due to the events; This spontaneous c... Read more
Passed out, blacked out, landed flat on her face, hospitalized due to the events; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out, blacked out, landed flat on her face, hospitalized due to the events) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The patient's past medical history included Nerve pain in July 2020, Carpal tunnel syndrome, Broken foot (40 years prior to reporting time.), Lung operation NOS in July 2020, Hip replacement in 2017, Hip replacement in December 2020, Bladder operation NOS in November 2020, Foot surgery, Knee surgery NOS, Shoulder operation NOS and Tubal ligation. Concurrent medical conditions included Allergy to antibiotic and Allergy. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], SERTRALINE, GABAPENTIN and ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]) for an unknown indication. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out, blacked out, landed flat on her face, hospitalized due to the events) (seriousness criterion hospitalization). The patient was hospitalized from 17-Apr-2021 to 19-Apr-2021 due to LOSS OF CONSCIOUSNESS. On 19-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out, blacked out, landed flat on her face, hospitalized due to the events) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Cardiac function test: normal (normal) normal. On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal, normal (normal) normal and normal (normal) CT Scan Head/Brain with Contrast. On an unknown date, Echocardiogram: normal (normal) normal. On an unknown date, X-ray: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient's Primary Care Physician scheduled an MRI and Carotid Artery Ultrasound after a week from the reporting time. She was also placed on a heart monitor for 30 days. This case concerns a 68-year-old female hospitalized with a serious unexpected event of Loss of consciousness. Event latency 5 days after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 68-year-old female hospitalized with a serious unexpected event of Loss of consciousness. Event latency 5 days after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
68 2021-05-01 palpitations, chest pain Burning began in the center of my chest that increased in area and intensity. It spread to my back ... Read more
Burning began in the center of my chest that increased in area and intensity. It spread to my back and the pain became a level 9. I was taken to the ER and treated for suspected heart attack. The diagnosis was finally made at esophagitis. I spent 5 days in that hospital. Three days later I experienced severe heart palpitations that caused dizziness for two hours to such a degree that I could not stand up. Over the course of the next six weeks, I continued to have daily episodic attacks of this nature with a lessening degree of symptoms each time. As of today, the symptoms have not recurred. Additionally, I began to experience significant hair loss at the same time as the onset of the other symptoms to such a degree that when brushing my hair I would get a fistful of it in my brush. The hair loss has slowly diminished, and as of today, the excessive hair loss has ceased.
68 2021-05-02 cerebrovascular accident patient suffered from a massive right ICA stroke on 4/22 (2 days after vaccine). stroke progressed t... Read more
patient suffered from a massive right ICA stroke on 4/22 (2 days after vaccine). stroke progressed to cerebral edema with evidence of herniation. she was intubated and unfortunately expired. not a neurosurgery candidate due to her age and signs of herniation.
68 2021-05-03 cardiac arrest patient went into cardiac arrest three times
68 2021-05-04 hypertension Was delirious for 2 days; Wasn't feeling good; Had high blood pressure; Had chills; Had fever; This ... Read more
Was delirious for 2 days; Wasn't feeling good; Had high blood pressure; Had chills; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Was delirious for 2 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Vertigo and Dizziness. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced DELIRIUM (Was delirious for 2 days) (seriousness criterion medically significant), FEELING ABNORMAL (Wasn't feeling good), HYPERTENSION (Had high blood pressure), CHILLS (Had chills) and PYREXIA (Had fever). On 04-Apr-2021, DELIRIUM (Was delirious for 2 days), FEELING ABNORMAL (Wasn't feeling good), HYPERTENSION (Had high blood pressure), CHILLS (Had chills) and PYREXIA (Had fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information not provided. Patient reported that all the possible adverse events subsided by 04-Apr-2021. Patient stated that she took combination medication of nexium, antihistamine, and unspecified third product which alleviated the adverse events. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
68 2021-05-04 loss of consciousness Passed out; Felt dizzy; Nasty taste in mouth; was feeling tired; This spontaneous case was reported ... Read more
Passed out; Felt dizzy; Nasty taste in mouth; was feeling tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced TASTE DISORDER (Nasty taste in mouth) and FATIGUE (was feeling tired). On 26-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and DIZZINESS (Felt dizzy). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Felt dizzy), TASTE DISORDER (Nasty taste in mouth) and FATIGUE (was feeling tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient had acetaminophen for the events. Action taken with mRNA-1273 in response to the drug was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case was linked.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested Dose 1 case
68 2021-05-04 palpitations Vertigo/whole room started spinning; Heart palpitations; Black/blue marks, left side of the neck has... Read more
Vertigo/whole room started spinning; Heart palpitations; Black/blue marks, left side of the neck has some black and blue marks; Coldness in right arm like pins and needles; Pain where the strap of the bra goes; Pins and needles; Shoulder has been hurting; Feeling of nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and VERTIGO (Vertigo/whole room started spinning) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Nausea, Vertigo and Headache. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations) (seriousness criteria hospitalization and medically significant), VERTIGO (Vertigo/whole room started spinning) (seriousness criteria hospitalization and medically significant), SKIN DISCOLOURATION (Black/blue marks, left side of the neck has some black and blue marks), FEELING COLD (Coldness in right arm like pins and needles), PAIN (Pain where the strap of the bra goes), PARAESTHESIA (Pins and needles), ARTHRALGIA (Shoulder has been hurting), NAUSEA (Feeling of nausea) and HEADACHE (Headache). The patient was hospitalized for 2 days due to PALPITATIONS. At the time of the report, PALPITATIONS (Heart palpitations), VERTIGO (Vertigo/whole room started spinning), SKIN DISCOLOURATION (Black/blue marks, left side of the neck has some black and blue marks), FEELING COLD (Coldness in right arm like pins and needles), PAIN (Pain where the strap of the bra goes), PARAESTHESIA (Pins and needles), ARTHRALGIA (Shoulder has been hurting), NAUSEA (Feeling of nausea) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, Red blood cell count: abnormal (abnormal) WBC count dropped. On an unknown date, White blood cell count: abnormal (abnormal) WBC count dropped. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient received second shot of vaccine and started getting vertigo, feeling of nausea and headache. She stated that one day my whole room started spinning and she had heart palpitations so she went to emergency room. The patient was admitted for 2.5 days for observation and put me on heart monitor. They went back to little normal after hospitalization. On an unknown date, something different for a week. The shoulder was hurting and noticing black/blue marks. Even the left side of the neck has some black and blue mark. The patient had coldness in right arm like pins and needles. She had lot of pain where the strap of the bra goes. The patient drank coffee for headache and did some exercise for vertigo that helped me with them. The hospital put me on high iron diet, gave her intravenous saline drip, asked me to walk around and not sit for too long. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
68 2021-05-05 hypertension At around 9 pm I felt a funny feeling in my lips that made me feel like I might have trouble talking... Read more
At around 9 pm I felt a funny feeling in my lips that made me feel like I might have trouble talking. It didn't last long, but my daughter suggested I take my blood pressure. It registered 177/90 something. Thought that was unusually high considering we had just been sitting talking for hours after my shot, no exertion at all. I felt good. We waited 15-20 minutes to check in again. No nervousness or anything. It had climbed into the 190/100 range. My daughter suggested we go to the ER. I didn't think it necessary. After maybe 20 minutes we took it again and it was just over 200/low 100 something. My daughter said sorry Mom but this is getting very high we are going to ER. We got there near 11:30 pm I believe. When we arrived my blood pressure registered 220/116. Doctors thought I hadn't taken my blood pressure medication. (wrong, I always take it) Doctors thought I was nervous about the shot. (wrong, it had been a very calm afternoon and evening with my adult daughter who is a health care provider. Tests came back fine. They had me stay for a little bit but then sent me home with instructions to see my Cardiologist the following week because they felt maybe my blood pressure meds were no longer adequate. I don't think they believed that extremely hight BP was from the vaccination, but I absolutely do. I saw my Cardiologist on Monday. He felt all was fine. Adjusted the dosage on one blood pressure med but did believe the high BP could have been from vaccination. On Sunday May 14 I took it easy. My BP came down slowly by increments of 10 for the systolic throughout the day. By Monday I was at 140/90 at home.
68 2021-05-06 blood pressure increased Client received the 1st dose of Moderna COVID vaccine on 4/8/21 lot #041B21A and expiration date 5/... Read more
Client received the 1st dose of Moderna COVID vaccine on 4/8/21 lot #041B21A and expiration date 5/26/21. Client returned for dose #2 on 5/6/21. Client reports having an increase of blood pressure within 7 hours of the vaccine on 4/8/21 and also having a burning sensation on the left side of her face, which is the side she received her vaccine. Client reports her blood pressure was 172/90 and then an hour later it was 162/80. Client reports calling her provider and them advising she goes to the emergency room. At the ER she received Tylenol, buspar and Ativan and reports she was anxious due to how she was feeling. Client reports she is allergic to penicillin, sulfa and novocaine. She reports a history of high blood pressure, gastritis and a hiatal hernia. Current vitals are 116/68:blood pressure, oxygen 100% and pulse: 56. Client reports this is her normal blood pressure with medication. Client reports medications are prilosec, bystolic, and hydrolyzene,
68 2021-05-06 hypertension 1ST dose Moderna Vaccine- Acute Hypertension with no other symptoms ( No headache, No chest pain, No... Read more
1ST dose Moderna Vaccine- Acute Hypertension with no other symptoms ( No headache, No chest pain, No tinnitus, No cardiac issues). Elevated BP could have been from the begining, however, since no other symptoms, it wasn't discovered until 24 hrs later. BP 160-190 mmHg HR 70-78 bpm remained in 180 for at least 4 hrs. 162 mg (2 tab) Baby aspirin, rest and hydration. On call MD contacted through clinic. Advised to administer 20 mg Lisinopril (Husband's med) if BP over 190 mmHg. Contact in AM for possible prescription if hypertension remains overnight. at 2300: BP 160/64 HR 76 with NO meds administered . slightly sore right arm at injection site.
68 2021-05-06 low blood oxigenation "Encephalopathy with worsening aspiration (already chronic aspirator) starting one day after second ... Read more
"Encephalopathy with worsening aspiration (already chronic aspirator) starting one day after second COVID." 68YF with baseline cerebral palsy and seizure disorder, mostly nonverbal at baseline, who presents on 3/30/21 to the hospital with several weeks of decreased alertness and decreased oral intake. Caregiver did report temporality associated with completion of COVID-19 vaccine. She was found to be hypoxic with evidence of aspiration pneumonia and with hypernatremia suggestive of poor PO intake. An EEG was performed that did not show any definite seizure activity. She was kept on telemetry while in the hospital which also captued several pausea, one up to 7 seconds long likely also contributing to her encephalopathy secondary to poor perfusion. She was evaluated by speech who did not feel that she was safe for any type of modified diet and would require tube feedings should this wish to be pursued. In addition, there was also evidence of acute blood loss anemia with suspected GI bleed. Palliative care was consulted. Her son and caregiver were contacted and wished to avoid PEG tube placement or further aggressive work-up. She was felt to qualify for hospice and hospice services at her prior group home were arranged. She was started on oral morphine while here in the hospital to help with air hunger, discomfort, and anxiety. In addition to oral morphine, she was discharged with liquid Augmentin to complete antibiotic course for aspiration pneumonia. On 4/5/21 (the day of discharge) Pt appeared less anxious than she had been. She is nonverbal at baseline but was awake and alert and reaching for the hand of any staff in the room. Discharge to group home on hospice.
68 2021-05-07 blood clot symptoms lasting for over 25 days: Major Headache , extreme exhaustion, trouble breathing (SOB), los... Read more
symptoms lasting for over 25 days: Major Headache , extreme exhaustion, trouble breathing (SOB), loss of taste/smell, worsening arthritis, congestion in lungs and head, diarrhea, blood clot in finger (just was seen in the ER for confirmed blood clot in finger)
68 2021-05-09 platelet count decreased low platelet one month following 2nd dose of moderna
68 2021-05-09 pulmonary embolism, chest discomfort, fibrin d dimer increased Lower extremity swelling, persistent shortness of breath and chest pressure for about a month. Recei... Read more
Lower extremity swelling, persistent shortness of breath and chest pressure for about a month. Received 2nd Covid vaccine on 4/1/2021 and a couple of days later started to have this chest pressure and shortness of breath. Was seen in the clinic on 4/9/2021 with upper respiratory symptoms and cough along with chest pressure. Covid/Flu/RSV PCR test was negative on 4/9/2021. Chest heaviness and shortness of breath persisted, though slowly improving. CTA on 5/7/2021- Showed large burden of pulmonary emboli extending from the lobar to the subsegmental pulmonary arteries and consolidation in the lateral right lower lobe is likely pulmonary infarct. Patient is being treated with Eliquis. Placed in Observation overnight 5/7/2021-5/8/2021.
68 2021-05-09 fainting, fast heart rate Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Letharg... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Tachycardia-Mild, Systemic: Weakness-Mild, Additional Details: post 20mins vaccination
68 2021-05-10 chest pain Had chest/back pain on 4/27. Thought it was a pulled muscle. Notice small rash on back on Friday mor... Read more
Had chest/back pain on 4/27. Thought it was a pulled muscle. Notice small rash on back on Friday morning. Thought it was due to cream used to help pulled muscle. Rash enlarged and was only on one side. Looked up "shingles" on Sunday 05/02/21. Diagnosed with shingles. Given prescriptions for valACYclovir 1 tablet by mouth 3 times a day until supply gone and Nortriptyline 1 capsule by mouth daily at bedtime.
68 2021-05-12 anaemia Fever, cough, fatigue, anemia over past 2.5 months
68 2021-05-12 chest discomfort After extensive review of patient consent form, patient received 1st Moderna COVID19 vaccine dose. A... Read more
After extensive review of patient consent form, patient received 1st Moderna COVID19 vaccine dose. Approximately 10 minutes later, patient complained of increased shortness of breath (patient experiences shortness of breath daily) and chest tightness. Pharmacy staff called 911 per patient request, patient was given water, and staff waited with patient until ambulance arrived. Patient was able to communicate and move self to stretcher where EMTs took patient from there.
68 2021-05-12 nosebleed She is bleeding behind retina so she can't see properly; Clot in retinal branch; She can't see prope... Read more
She is bleeding behind retina so she can't see properly; Clot in retinal branch; She can't see properly; She sees blurry; Light nose bleed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL HAEMORRHAGE (She is bleeding behind retina so she can't see properly) and RETINAL VASCULAR OCCLUSION (Clot in retinal branch) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced EPISTAXIS (Light nose bleed). On 22-Apr-2021, the patient experienced VISION BLURRED (She sees blurry). On 29-Apr-2021, the patient experienced RETINAL HAEMORRHAGE (She is bleeding behind retina so she can't see properly) (seriousness criterion medically significant), RETINAL VASCULAR OCCLUSION (Clot in retinal branch) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (She can't see properly). At the time of the report, RETINAL HAEMORRHAGE (She is bleeding behind retina so she can't see properly), RETINAL VASCULAR OCCLUSION (Clot in retinal branch), VISUAL IMPAIRMENT (She can't see properly), VISION BLURRED (She sees blurry) and EPISTAXIS (Light nose bleed) outcome was unknown. Patient started with light nose bleed 2 days after receiving vaccine. Then 2 weeks ago, she developed problem with her eyes. She mentions that she sees blurry. She went to doctor on 29Apr2021 and doctor said that there was a clot in retinal branch and she is bleeding behind retina so she can't see properly. Treatment medication includes: Vastin Injection for the eyes Concomitant medication includes: BP medicine Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
68 2021-05-12 hypotension, low blood pressure audio and visual hallucinations; diarrhea; low blood pressure; earache; mental fog; coordination pro... Read more
audio and visual hallucinations; diarrhea; low blood pressure; earache; mental fog; coordination problems; head rushes; crackling; Eyes not following finger test; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATIONS, MIXED (audio and visual hallucinations) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included SIMETICONE (GAS X), PARACETAMOL (TYLENOL) and VITAMINS NOS for an unknown indication. On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HALLUCINATIONS, MIXED (audio and visual hallucinations) (seriousness criterion medically significant), DIARRHOEA (diarrhea), HYPOTENSION (low blood pressure), EAR PAIN (earache), FEELING ABNORMAL (mental fog), COORDINATION ABNORMAL (coordination problems), ORTHOSTATIC HYPOTENSION (head rushes), CREPITATIONS (crackling), EYE MOVEMENT DISORDER (Eyes not following finger test) and DIZZINESS (Dizziness). At the time of the report, HALLUCINATIONS, MIXED (audio and visual hallucinations) and DIARRHOEA (diarrhea) had resolved, HYPOTENSION (low blood pressure), EAR PAIN (earache), FEELING ABNORMAL (mental fog), COORDINATION ABNORMAL (coordination problems), ORTHOSTATIC HYPOTENSION (head rushes), CREPITATIONS (crackling) and EYE MOVEMENT DISORDER (Eyes not following finger test) had not resolved and DIZZINESS (Dizziness) outcome was unknown. The arm that the patient received each dose was not confirmed. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
68 2021-05-12 palpitations Sweating, body aches, chills, heart palpatations, stomach cramps, rash on my upper torso that lo... Read more
Sweating, body aches, chills, heart palpatations, stomach cramps, rash on my upper torso that look like tiny red small strawberries weakness and headache. Took some benadryl. Stayed home 3 days in bed to get myself together.
68 2021-05-15 blood pressure increased, hypertension 1010 Lightheadness, 1st vaccine reports Hx of HTN did not take meds. BP 160/88,HR 66,sats 99%, Resp ... Read more
1010 Lightheadness, 1st vaccine reports Hx of HTN did not take meds. BP 160/88,HR 66,sats 99%, Resp 16. 1024 symptoms resolved. States she feels ok to go home refused BP states she will go take her meds. S/S to seek immediate Care for reviewed. She verbalized understanding. Left ambulating for home.
68 2021-05-16 cardiac failure congestive, heart attack Admitted CHF and NSTEMI, CC SOB
68 2021-05-16 cardio-respiratory arrest, cardiac arrest Witnessed Cardiac arrest at home. No bystander CPR; +30 min transport time, unsuccessful resuscitati... Read more
Witnessed Cardiac arrest at home. No bystander CPR; +30 min transport time, unsuccessful resuscitation. Code called upon arrival to hospital
68 2021-05-16 pulmonary embolism Bilateral Pulmonary Emboli
68 2021-05-17 blood glucose increased Beginning about 04/25, extreme fatigue, scratchy/ swollen throat, low-grade fever. Persistent cough... Read more
Beginning about 04/25, extreme fatigue, scratchy/ swollen throat, low-grade fever. Persistent cough with chest congestion. Symptoms still persist today (05/18). Doctor has had Covid and Strep tests run - negative. Blood work did not reveal anything alarming.
68 2021-05-17 fainting fall/syncope
68 2021-05-18 heart rate abnormal At the moment I went to bed I felt a change in my heartbeat. I have never felt this before. But toda... Read more
At the moment I went to bed I felt a change in my heartbeat. I have never felt this before. But today I have not felt it again.
68 2021-05-18 heart rate abnormal Rapid HR. Possible SOB. BP:164/95 Pulse:98 Resp:18 Spo2=97% Recorded by healthcare worker
68 2021-05-19 palpitations Given Moderna injection 0811 lightheadedness, tightness left side of throat and scratchiness at 082... Read more
Given Moderna injection 0811 lightheadedness, tightness left side of throat and scratchiness at 0822 dizziness at 0823 assisted to stretcher, at 0823 Benadryl 50mg po at 0824 Hospital emergency team called Sent to ED for follow up pulse 110 BP 158/104 resp 22 Discharged from ED 1006 still complaining of palpitations went home for the day family will be with her
68 2021-05-22 inflammation of the pericardium, chest pain The patient presented to the ER with chest pain on April 11, approximately 13 days after receiving t... Read more
The patient presented to the ER with chest pain on April 11, approximately 13 days after receiving the second dose of COVID vaccine. She then developed dyspnea about a month later and was subsequently found to have a moderate sized bloody pericardial effusion and pericarditis on May 18th, for which no alternate cause has been found.
68 2021-05-23 arrhythmia arrhythmias
68 2021-05-24 fast heart rate, blood glucose increased Presented to ED with nausea/vomiting and abdominal pain the day after second dose of Moderna. Patien... Read more
Presented to ED with nausea/vomiting and abdominal pain the day after second dose of Moderna. Patient had 2 weeks of upper abdominal pain as well as intermittent nausea and vomiting. She denied having any diarrhea. She said that she had had gastric ulcers in the past, though at least several years ago. She was not on any acid blockers prior to admission. She denied any hematemesis or coffee-ground emesis, and did not have any melena. On admission, she had lab work significant for elevated WBC of 12.6. Serum chemistries were significant for a sodium of 133, bicarbonate of 19, glucose of 273, and calcium was initially elevated at 10.5. Magnesium was low at 1.4. The patient also did have some wide complex tachycardia, which resolved, and she was given magnesium. Patient admitted and found to have grade B esophagitis, and also multiple gastric ulcers which were not bleeding at the time of the study. The patient had been empirically placed on Protonix and was kept on this throughout her hospitalization. She was discharged with a prescription for omeprazole and will need to take it daily and have repeat EGD in 2 months.
68 2021-05-25 low blood platelet count Sore Throat in Neck Area; Diagnosed with ITP; This spontaneous case was reported by a consumer (subs... Read more
Sore Throat in Neck Area; Diagnosed with ITP; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M2EA and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat in Neck Area). On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) and OROPHARYNGEAL PAIN (Sore Throat in Neck Area) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 10,000 (Low) Platelets had dropped to 10,000 and 47,000 (Low) Decreased. Concomitant medications were not reported. Patient went to urgent care and blood work revealed that her platelets had dropped to 10,000 and she was directed to the emergency room and was treated with steroids and gamma globulin. She was diagnosed with ITP and treated with 4 infusions of Rituxan and her platelets are still low at 47,000. Treatment information were included gamma globulin, steroids, 4 infusions of Rituxan at hospital. Action taken with mRNA-1273 in response to the event was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
68 2021-05-25 pulmonary embolism Pulmonary embolism Pneumonia
68 2021-05-27 palpitations She got her vaccine, first she had a little sore arm on the left. Then she started getting headache... Read more
She got her vaccine, first she had a little sore arm on the left. Then she started getting headaches. On Tuesday afternoon she started getting a light fever, chills, sweating, no appetite, diarrhea, and also her heart was racing high. Body aches all over. She called her doctor and she suggested for her to take Tylenol and to drink plenty of fluids and to eat dry toast as she was not able to hold anything down. She did not like the rapid heart beat. She told her if her heart beat to go to the ER. She had COVID in December and was in the hospital for 3 weeks and had pneumonia and other symptoms and recovered from that, and then put in rehab center for 2 more months from 1/1/21 to 3/3/21. She is still recovering, does get out of breath easily and is home bound and has to use oxygen when she moves around. She was not on oxygen before having COVID. She checks her heart rate and oxygen level every day since having the COVID and is recovered from the vaccine. She does FU with her doctor weekly due to the COVID virus.
68 2021-05-31 heart flutter, palpitations Heart fluttering; Palpitations; Ringing in ears; sleeping a lot; Pain in arm; feeling fatigued; This... Read more
Heart fluttering; Palpitations; Ringing in ears; sleeping a lot; Pain in arm; feeling fatigued; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant), PALPITATIONS (Palpitations), TINNITUS (Ringing in ears), SOMNOLENCE (sleeping a lot), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (feeling fatigued). On 14-Apr-2021, CARDIAC FLUTTER (Heart fluttering), PALPITATIONS (Palpitations), TINNITUS (Ringing in ears), SOMNOLENCE (sleeping a lot), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (feeling fatigued) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. No treatment medication was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-155061 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
68 2021-06-03 loss of consciousness broke her ankle; blacked out and passed out; trouble breathing; didn't feel good; nauseated; felt li... Read more
broke her ankle; blacked out and passed out; trouble breathing; didn't feel good; nauseated; felt light headed; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out and passed out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided. Concomitant products included PREDNISOLONE, TIMOLOL, LABETALOL and LOSARTAN for an unknown indication. On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (felt light headed), MALAISE (didn't feel good) and NAUSEA (nauseated). On 09-Apr-2021, the patient experienced DYSPNOEA (trouble breathing). On 11-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out and passed out) (seriousness criterion medically significant) and JOINT INJURY (broke her ankle). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out and passed out), DIZZINESS (felt light headed), JOINT INJURY (broke her ankle), DYSPNOEA (trouble breathing), MALAISE (didn't feel good) and NAUSEA (nauseated) outcome was unknown. Treatment medications were not provided. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
68 2021-06-05 cardiac failure congestive, ejection fraction decreased Shortness of breath leading to new diagnosis of congestive heart failure; prior excellent aerobic ca... Read more
Shortness of breath leading to new diagnosis of congestive heart failure; prior excellent aerobic capacity
68 2021-06-06 loss of consciousness In the middle of the night i had a lot of pain did not take any medication but had a lot of pain and... Read more
In the middle of the night i had a lot of pain did not take any medication but had a lot of pain and when I woke up to give food to my dog i passed out on the floor of kitchen.
68 2021-06-07 loss of consciousness I got up at 06:00 and sat up and I felt body aches and headache. As the morning went on, I took a co... Read more
I got up at 06:00 and sat up and I felt body aches and headache. As the morning went on, I took a couple of Tylenol and went back to sleep. I felt dizzy and nauseous when I woke up - with body aches. That went on the whole day. I stayed in bed all day. I felt like I had been drugged. By 05:00 pm, I decided to go downstairs and I felt really hot and went out to patio and sat down. I had laid my head back and I guess I had passed out - eyes had rolled back into my head. My daughter called Paramedics - they did some tests and then helped me back to my bed. My daughter gave me another Tylenol - I still felt achy, nauseous and headache. The next morning, I felt a little better. The third day - was still really tired and weak. I finally came downstairs to work on Thursday. I still felt like my energy was drained but the achiness, headache and nausea were going away on Wednesday and Thursday. But I was still tired. By the weekend, I started getting better. I didn't go anywhere but I was feeling much better than I had.
68 2021-06-08 atrial fibrillation Patient presented to the ED for atrial fibrillation on 4/9/21 and 4/20/21. Patient was hospitalized ... Read more
Patient presented to the ED for atrial fibrillation on 4/9/21 and 4/20/21. Patient was hospitalized for atrial fibrillation .
68 2021-06-10 heart attack, troponin increased, fainting 5/15 sustained syncope, fall hypoxic respiratory failure COPD pneumonia vomiting/diarrhea admitted t... Read more
5/15 sustained syncope, fall hypoxic respiratory failure COPD pneumonia vomiting/diarrhea admitted to the hospital acute kidney injury 5/15--ED--cervical fracture, acute MI, elevated troponin multiple cardiology appointments, follow up appointments since then another emergency room visit on 6/10/21.
68 2021-06-10 anaemia, cerebrovascular accident Pt had her 2nd covid 19 vaccine on 5/4/21 and was admitted to the hospital with an acute cryptogenic... Read more
Pt had her 2nd covid 19 vaccine on 5/4/21 and was admitted to the hospital with an acute cryptogenic stroke on 5/28/21 with sudden R sided facial droop with NIHSS of 6, R sided weakness, expressive aphasia and was given TPA as ct head was neg for hemorrhage. CTA head and neck negative for any stenosis, ldl was 74, follow up mri brain post TPA was negative. Pt also had hyponatremia on admit of which was corrected by discharge. She also fell pta and was admitted with a colles fracture which was reduced at the bedside by orthopedics and casted. She was admitted from 5/28-5/31 and discharged home with her family.
68 2021-06-11 palpitations Heart started skipping beats in mid April through current date. Went to doctor who ordered a heart m... Read more
Heart started skipping beats in mid April through current date. Went to doctor who ordered a heart monitor for 2 weeks. Results show PVC's Also doctor order 2nd blood pressure pill on 6/2/21 due to extremely high blood pressure readings taken at home.
68 2021-06-13 chest discomfort, chest pain, transient ischaemic attack Presenting symptom: dysartrhia and aphasia without evidence of underlying cause. Patient has been h... Read more
Presenting symptom: dysartrhia and aphasia without evidence of underlying cause. Patient has been having continued TIA type symptoms with chest pressure & pain. Difficulty in walking, speaking, arm drift. This has happened on 3 different hospital occasions. Negative cardiac workup, negative brain scan. Presumptive dx TIA. No prior history, no family history, no underlying medical reason.
68 2021-06-13 chest pain Patient reported chest pain as well as neck, back and arm pain that started today.
68 2021-06-14 blood pressure increased, palpitations, heart rate increased 2/5/21 -Rapid heart rate, heart palpitations lasting from 7pm til 10 am next morning 2/21/21- Anothe... Read more
2/5/21 -Rapid heart rate, heart palpitations lasting from 7pm til 10 am next morning 2/21/21- Another bout of heart palpitations lasting from 7 pm til about 10 am next morning 2/22/21- Urgent care visit. Blood drawn and EKG. No heart attack indicated. Scheduled stress test with echocardiogram and heart monitor 2/26/21 -2nd Moderna vaccine administrered 3/12/21 - Heart palpitations and rapid heart rate lasting 7 pm til mid morning 3/13/21- Urgent Care visit, 3/16/21 - Cardioloty lab for stress test, echocaridogram and fitted for Zio heart monitor 3/25/21 Psychotherapy for anxiety, depression, fear of going out despite being vaccinated 4/1/21 - Urgent care for head cold, cold sore on lip and nose, scratchy throuat mild earache. Negative tests for both STREP and Covid. 4/6/21 - Urgent Care. Head cold moved to chest, dry cought, 99.1 temp, extreme fatigue and lethargy, emotional panic, depression. Negative covid test. 4/7/21 Psychotherapy for depression and anxiety 4/12/21- First sign of Granuloma Anulare in more than 2 years 4/17/21-ER visit due to heart palpitations, tightness in jaw line, shortness of breath starting at 7 pm.ELG abnormal, 140 pulse, elevated blood pressure. Monitored til stable. Started blood thinner, Eliquis
68 2021-06-14 heart flutter So it only happened about 3x and for I'd say 15-30 seconds, and it was heart flutters. Unrelated, ha... Read more
So it only happened about 3x and for I'd say 15-30 seconds, and it was heart flutters. Unrelated, has never happened before. Either sitting or walking randomly it would happen just at random times after the vaccine. I called the DR and did not go in because I am unable to travel easily. Out of the blue I got this text from CDC so I did put it in there because I am very healthy otherwise, I have no medical conditions. The last time it happened was a couple weeks ago.
68 2021-06-15 hypertension, palpitations Around the 28th or 29th of April, I started having shortness of breath and my heart was racing. I t... Read more
Around the 28th or 29th of April, I started having shortness of breath and my heart was racing. I took my blood pressure and it was high. My pulse was 116. I went to urgent care and they checked for signs of a heart attack or blood clot and everything came back okay, 3 days later I went to the ER at Medical Center and they took a chest x-ray and spoke with a cardiologist. Over the next month I was feeling better. Now I'm seeing a cardiologist who is going to complete a carotid artery study and at the end of the month she will try to ween me off the high blood pressure medication she will also complete blood work because she wants to check my body for inflammation that may be caused by the vaccine. I was prescribed Kargel 6.25 mg twice daily while at the ER which I am still taking.
68 2021-06-17 pulmonary embolism, enlargement of the heart Idiopathic bilateral systemic pulmonary embolisms and enlarged right heart
68 2021-06-17 fainting After receiving the second dose of moderna. My mom started experience some kind of vertigo. She has ... Read more
After receiving the second dose of moderna. My mom started experience some kind of vertigo. She has never in her life experience that. She went to ther doctor and he gave her some medication but it does not help. She faint and fell this week. Prior to the vaccine she was fine.
68 2021-06-18 chest discomfort Chest pressure, weak and febrile generally overall. All began the morning after the vaccination. Hea... Read more
Chest pressure, weak and febrile generally overall. All began the morning after the vaccination. Headache began morning of 3rd day post vax.
68 2021-06-20 palpitations After recovering form arm pain, and fatigue, 3 weeks later started palpitations and shortness of bre... Read more
After recovering form arm pain, and fatigue, 3 weeks later started palpitations and shortness of breath upon walking
68 2021-06-22 chest pain, cerebrovascular accident chest pains March 19 went to hospital admitted was given potassium for chest pains. May 24 in the e... Read more
chest pains March 19 went to hospital admitted was given potassium for chest pains. May 24 in the evening had a stroke on left side . called 911 . was admitted . stayed 3 days .3 days in rehahab
68 2021-06-24 heart flutter, palpitations Developed heart fluttering and palpitations on April 4, 2021, approximately 10 days after injection.... Read more
Developed heart fluttering and palpitations on April 4, 2021, approximately 10 days after injection. Symptoms continued over the next month to two months. Had an echocardiogram on June 18Which showed mild mitral valve regurgitation and had a Holter monitor placed on June 15 which was also abnormal. Appointment was a cardiologist upcoming on August 27. No prior history of palpitations or heart issues
68 2021-06-24 palpitations, fibrin d dimer increased, blood pressure decreased, blood glucose increased I actually tested positive for Covid 10 days after my first dose of the vaccine and ended up having ... Read more
I actually tested positive for Covid 10 days after my first dose of the vaccine and ended up having numerous issues and was referred to the long term Covid clinic. Balance issues, wheezing, cough, palpitations, headaches, shortness of breath, extreme fatigue, high blood sugars, blood pressure dropped
68 2021-06-28 ejection fraction decreased On March 1, 2021, I started getting shortness of breath I would wake up after two hours of sleep and... Read more
On March 1, 2021, I started getting shortness of breath I would wake up after two hours of sleep and I would wake up on the side of the bed and I could not catch my breath. I was coughing then about 7am in the morning March 2, 2021, I would be able to catch my breath but towards the end of the day I start having shortness of breath, but it wasn't that bad. After that, every night it started getting longer that I couldn't breathe at night, and every night the hours of my shortness of breath just kept getting longer and longer. Okay, so I called the doctor on March 9th, 2021 and had to have a virtual doctor's appointment and at that time during my appointment I was also having a tough time breathing while talking to my doctor so he said he would call me back at 8am, on March 3, 2021, he wanted me to come in so I went to his office at 9:30am and then while at my appointment he listened to my heart and did a EKG test and then he sent me over to the lab to get blood work, a chest x-ray, and then later in the day he sent for a CTA scan. Nothing was really coming back on the tests and then I came back in two weeks later and he gave me in inhaler to see if that help take care of my breathing. Then on March 26, is when I had my second covid vaccine and I went back to my doctor on April 8th, 2021 and I was still having the breathing problems. On April 25, 2021 around Sunday on 3:00pm, I could not walk 3 ft because of my shortness of breath so I went to the ER on the same day around 3:30pm. They took more x-rays and blood work and at 6pm on April 25, 2021, they admitted me into the hospital. They just ran more tests: CT scan, Heart Catheter, and an echocardiogram and more blood work. There were no blockages in my heart and my injection fraction was at 29%. I was released from the hospital on April 27, 2021.
68 2021-06-29 blood pressure increased Increase blood pressure , fatigue, with second shot very dizzy. Doctor put off for 2 days till blo... Read more
Increase blood pressure , fatigue, with second shot very dizzy. Doctor put off for 2 days till blood pressure came down
68 2021-06-30 heart rate increased - Vertigo for over 2+ months since vaccinated; - Increased shortness of breath over 2+ months sine ... Read more
- Vertigo for over 2+ months since vaccinated; - Increased shortness of breath over 2+ months sine vaccinated; - Increased heart rate, as high as 133 bpm, and maintaining over 100 for over 2+ months since vaccinated; - Dehydration for over 2+ months since vaccinated; - Increased respiratory rate, 18-20 breaths per minute, for over 2+ months since vaccinated - Extreme fatigue/malaise for over 2+ months since vaccinated; - Dizziness for over 2+ months since vaccinated; - Loss of appetite for over 2+ months since vaccinated; - Depression for over 2+ months since vaccinated;
68 2021-07-04 blood pressure increased PT BEGAN TO DEVELOP SIGNIFICANT SWELLING IN ANKLES/LOWER EXTREMITIES, AND THEN ALSO IN HANDS. SHE ... Read more
PT BEGAN TO DEVELOP SIGNIFICANT SWELLING IN ANKLES/LOWER EXTREMITIES, AND THEN ALSO IN HANDS. SHE MONITORED THIS HERSELF FOR 3 WEEKS, BEFORE GOING TO HER PRIMARY CARE PHYSICIAN. SHE WAS ADMITTED SHORTLY AFTER TO ER AS HER BP HAD ALSO RISEN SIGNIFICANTLY FROM A NORMAL BP OF 106/80 TO 199/99. SHE REMAINED IN THE HOSPITAL FOR SEVERAL DAYS AS THEY WORKED TO GET THE FLUID AND SWELLING DOWN (WHICH PT REPORTS WAS 15 LBS WORTH OF WEIGHT) AND IT WAS DISCOVERED SHE WAS SPILLING PROTEINS IN HER URINE. SHE WAS ALSO REFERRED TO A NEPHROLOGIST WHO SENT KIDNEY BIOPSY TO ANOTHER CLINIC (THE REPORTS CAME BACK NEGATIVE FOR ANY TYPE OF CANCER). SHE ALSO REPORTS THAT SHE HAS COVID EYES (RED AND PUFFY EYES) AND IS USING MOISTURIZING DROPS REGULARLY FOR COMFORT. PT ALSO REPORTS THAT SHE HAD COVID IN OCT. OF 2020 SHE RECIEVED HER 2ND MODERNA VACCINE ON 4/23/21
68 2021-07-05 hypertension I was OK for several days after the shot and then I got up 6 days later not feeling well and couldn'... Read more
I was OK for several days after the shot and then I got up 6 days later not feeling well and couldn't figure out what was going on. I am a nurse so I checked my pulse Ox and then my blood pressure and my BP was 150 over 100 which was high for me. I waited about 4 hours and still did not feel well and took it again and it was 175 over 100. I called the Doc and he told me to "watch" it and he wasn't concerned. So I sat on it until 9PM when I was really feeling bad I called the answering service and my BP was 200/110. The doc on call put me on Amlodipine and it lowered the pressure. The next day I ended up in the ER again with elevated BP and after that my cardiologist started to check things out and found that my aortic valve had gone from moderate to severe and that I needed a new valve. I cannot say if the valve issue getting worse was a factor of the vaccine but I do know that the elevated BP was....it actually saved my life because they started to dig around and found the valve was nearly closed. Had my BP not risen after the shot they may not have known the extent of the valve problem!
68 2021-07-06 chest discomfort, chest pain, palpitations Headache, ringing ears, excessive brain noise, brain zaps, eyes shake, cross-eyes, vertigo, excessiv... Read more
Headache, ringing ears, excessive brain noise, brain zaps, eyes shake, cross-eyes, vertigo, excessive night sweats and chills, neck spasm, Hallucination, hearing voices, seeing visions, cough, dry throat, shortness of breath, strange smell, confusion, lability, depression. Chest pain/pressure, heart racing/pounding, nausea, diarrhea, twitching, tingling, skin crawling/itchiness, Shoulder/ elbow/ hip/ ankle (joint) pain, leg/arm cramping, jerking, hands shake, toe curl. The one that really gets me is my hands shaking, the vaccine has entered my brain and causing neurological palsy.
68 2021-07-06 hypotension Approximately 3 weeks of watery diarrhea with hypotension and increased serum creatinine. Hypotensio... Read more
Approximately 3 weeks of watery diarrhea with hypotension and increased serum creatinine. Hypotension may have been exacerbated by about 25 pound gradual weight loss over course of prior 15 pandemic months without adjustment of BP meds in addition to acute dehydration with diarrhea. Resolved with low residue diet and elimination of amlodipine and chlorthalidone and vitamin B12 sequentially over course of 2-3 weeks.
68 2021-07-06 palpitations, hypertension, chest pain High blood pressure; chest pain; Heart racing; couldn't move off couch; not feeling well; Hard to th... Read more
High blood pressure; chest pain; Heart racing; couldn't move off couch; not feeling well; Hard to the touch Injection Site; Vaccination site Bump; arm still presents a little bit of swelling on injection site; little bit of redness on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy (Penicillin allergy) and Pollen allergy (Pollen). Concomitant products included CETIRIZINE HYDROCHLORIDE for Allergy. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm still presents a little bit of swelling on injection site) and VACCINATION SITE ERYTHEMA (little bit of redness on the Injection Site). On 08-Feb-2021, the patient experienced VACCINATION SITE MASS (Vaccination site Bump) and VACCINATION SITE INDURATION (Hard to the touch Injection Site). On 10-Feb-2021, the patient experienced HYPERTENSION (High blood pressure) (seriousness criterion hospitalization) and MALAISE (not feeling well). On 12-Feb-2021, the patient experienced PALPITATIONS (Heart racing) and MOBILITY DECREASED (couldn't move off couch). On an unknown date, the patient experienced CHEST PAIN (chest pain). The patient was hospitalized from 14-Feb-2021 to 15-Feb-2021 due to HYPERTENSION. The patient was treated with METOPROLOL SUCCINATE from 11-Feb-2021 to 12-Feb-2021 for Blood pressure high, at a dose of 25 milligram and AMLODIPINE BESILATE (AMLOPINE) ongoing from June 2021 for Blood pressure management, at a dose of 2.5 milligram. At the time of the report, HYPERTENSION (High blood pressure), VACCINATION SITE SWELLING (arm still presents a little bit of swelling on injection site) and VACCINATION SITE ERYTHEMA (little bit of redness on the Injection Site) had not resolved and PALPITATIONS (Heart racing), CHEST PAIN (chest pain), VACCINATION SITE MASS (Vaccination site Bump), MALAISE (not feeling well), MOBILITY DECREASED (couldn't move off couch) and VACCINATION SITE INDURATION (Hard to the touch Injection Site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Blood pressure measurement (117-125): 160-180 (High) 160-180. On 14-Feb-2021, Blood pressure measurement (117-125): >200 (High) over 200. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 11-Feb-2021, the patient consulted a doctor for high blood pressure and was prescribed metoprolol succinate ER (extended release). She took only one pill. On 14-Feb-2021, she went to the hospital and was admitted till 15-Feb-2021. Various tests were done, including CT scan on lungs. She was recommended to see a cardiologist. Her appointment with the internist was on 12-Mar-2021 and with the cardiologist was on 07-Apr-2021. She was given a prescription for amlopine. She reported that her blood pressure was still fluctuating above 160-165. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-025495 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow Up information was received on 23-Jun-2021 ADR form updated. Added lab details, medical history, concomitant medication, new events (chest pain, high BP and heart racing), outcome of events, hospitalization details, treatment medications, demographics, race, physician details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
68 2021-07-07 palpitations, pallor, loss of consciousness On 6/8/2021, I went for a walk that day and after I finished my walk and got in my car to drive ho... Read more
On 6/8/2021, I went for a walk that day and after I finished my walk and got in my car to drive home. About 5 minutes later, I felt dizzy and I started to pull over and I passed out. When I woke up, I was on the side of the rode in a bush. I called 911 and the ambulance and police came. By the time the ambulance came, I felt fine and had no symptoms. I was take to the hospital. They ran every test they could think of. Blood work, EEG, EKG, MRI. Everything came back normal. I stayed over night and the next day, they did a 24 hour cardiac monitor and everything came back normal. I was discharged to follow up with my cardiologist. My driver's license was revoked. After I was discharged from the hospital, I was still feeling very tired, intermitten fuzzy feeling on my face near my jaw right in front of my ears, and intermitten heart palpitations. I did follow up with my cardiologist and my incident had nothing to do with my heart, but also does not know what could have caused it. He wanted me to follow up with my primary care doctor. I did see my PCP and he concluded that my incident was viral related. My friends and family have also commented to me on several occasions that I continue to look pale.
68 2021-07-08 chest pain Sharp chest pains, got real tired with shortness of breath
68 2021-07-14 chest pain, atrial fibrillation Next day legs "felt wobbly" and SOB upon activity. Felt burning in chest within the next few days wh... Read more
Next day legs "felt wobbly" and SOB upon activity. Felt burning in chest within the next few days which is still experienced- worsened when fatigued. SOB continues with activity as well. Continues to feel fatigued with no activity. Has reported to HCP and is undergoing testing. Patient also had developed cellulitis in her right foot without any previous injury in the end of May. Has had increased episodes of atrial fibrillation- last episode had been in August of 2020, now under control. Currently still experiencing SOB, fatigue and burning sensation in chest.
68 2021-07-17 loss of consciousness Here is some other information. My first Moderna shot for the Covid 19, was on April 22nd. Approxim... Read more
Here is some other information. My first Moderna shot for the Covid 19, was on April 22nd. Approximately 12 noon. This shot was also in my upper left arm. A few days later, I developed an allergic reaction in the form of a "rash". I did not have any other symptoms. I waited a few days and then went to my doctor. She told me to take a Benadryl on the day of the second shot. I did so on the morning of the second shot (before I went for the second shot). The lot number was: B40B21A. My second shot was May 20th at approximately noon. I was fine for the rest of the day and night. Then at approximately 3:30AM on May 21st, I woke up and was extremely thirsty. I drank some Gatorade and went back to be. I got up at approximately 7AM. I started sweating, feeling faint and then passed out. I also now have "swelling: around the right side of my neck area. It feels "puffy". I went back to my doctor and she sent me for a carotid artery test. It was negative. However, the "swelling" is still there. I wonder and hope the "swelling" will go away.
68 2021-07-21 cerebrovascular accident I had a stroke on April 3, 2021. Affected right side of body. arm, leg and dominant hand and speech... Read more
I had a stroke on April 3, 2021. Affected right side of body. arm, leg and dominant hand and speech.
68 2021-07-21 loss of consciousness 10 minutes after receiving the vaccine, I looked at the clock and remembered thinking "Wow. I'm rea... Read more
10 minutes after receiving the vaccine, I looked at the clock and remembered thinking "Wow. I'm really tired." I also remembered I only have 5 minutes left to sit here. The last thing I remember is someone tapping on me and shouting asking if I was okay. I had been unresponsive for about 30 seconds. A lady that was watching me said my eyes went shut and my chin hit my chest as I was talking to her. They called an ambulance and my initial blood pressure was 70/40. I was transported to the ER and was given IV fluids. They did bloodwork but nothing showed anything. The doctors don't know why the vaccine dropped my blood pressure and caused me to be unresponsive. Ever since the vaccine I have battled with extreme tiredness.
68 2021-07-23 blood clot Almost immediately after receiving the second dose, she experienced having no strength or energy/her... Read more
Almost immediately after receiving the second dose, she experienced having no strength or energy/her weakness is severe/ after taking a shower she must lay down to regain her strength/doesn't have the energy to hardly do anything now; Hard for her to complete a shower; Can't hardly stand by the stove to cook/she can hardly keep herself standing up; ongoing cough; Left foot started to swell; Has been going downhill; Blood clot in her left leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in her left leg) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer (Breast cancer under arm; left side, at the age of 62) in 2015 and Chemotherapy (Stopped chemotherapy treatment during Moderna vaccination series. Restarted after 2 weeks before the time of reporting.) since an unknown date. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced THROMBOSIS (Blood clot in her left leg) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENIA (Almost immediately after receiving the second dose, she experienced having no strength or energy/her weakness is severe/ after taking a shower she must lay down to regain her strength/doesn't have the energy to hardly do anything now), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hard for her to complete a shower), DYSSTASIA (Can't hardly stand by the stove to cook/she can hardly keep herself standing up), COUGH (ongoing cough), PERIPHERAL SWELLING (Left foot started to swell) and GENERAL PHYSICAL HEALTH DETERIORATION (Has been going downhill). The patient was treated with RIVAROXABAN (XARELTO) for Anticoagulant therapy, at an unspecified dose and frequency and BENZONATATE for Cough, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clot in her left leg), ASTHENIA (Almost immediately after receiving the second dose, she experienced having no strength or energy/her weakness is severe/ after taking a shower she must lay down to regain her strength/doesn't have the energy to hardly do anything now), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hard for her to complete a shower), DYSSTASIA (Can't hardly stand by the stove to cook/she can hardly keep herself standing up), COUGH (ongoing cough), PERIPHERAL SWELLING (Left foot started to swell) and GENERAL PHYSICAL HEALTH DETERIORATION (Has been going downhill) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: abnormal (abnormal) Diagnosed with a blood clot in her left leg.. Patient was given iron injection to regain her energy levels that she lost after the vaccination. It helped her initially but at the time of reporting it was not helping her much. She was prescribed Xarelto for 3 months to treat the blood clot. Patient states that she has no drug or food allergies. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Further information is not expected. This case was linked to MOD-2021-264079 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Further information is not expected.
68 2021-07-27 heart failure, palpitations Heart palpitations that continued and increased resulting in heart failure and muscle damage
68 2021-07-28 blood pressure increased, fast heart rate, loss of consciousness 5 minutes after receiving the vaccine, I had a severe flushing throughout my body and my throat bega... Read more
5 minutes after receiving the vaccine, I had a severe flushing throughout my body and my throat began to swell. My blood pressure spiked and I got nauseous and felt like I was going to pass out. I immediately took 2 benedryl tablets and went to the ER to get Prednisone. It lasted throughout the night and seemed to be better in the morning. However, I continued to have allergic reactions daily, for the next 3 weeks. I believe I then caught Covid 19 from the ER. I got monoclonal antibodies treatment and my case of Covid did not require hospitalization. I now have Long Covid, and have for the last 5 months. I have not developed MCAS
68 2021-07-28 skin turning blue, pallor Eye sight White spots started forming until I couldn't see. Face was white, lips were blue. Laste... Read more
Eye sight White spots started forming until I couldn't see. Face was white, lips were blue. Lasted about 40 minute, when eyesight was coming back, I could see it moving like a line slowing from right to left until it disappeared & my sight was back completely. Had to be driven home from work. When eyesight was back hen chills, sick to stomach, fever. These symptoms lasted about 12 hours.
68 2021-07-28 palpitations Diarrhea and heart palpitation
69 2021-01-06 palpitations Migraine headache, Heart palpitations, Site redness and edematous with pruritus lasting longer than ... Read more
Migraine headache, Heart palpitations, Site redness and edematous with pruritus lasting longer than a week and size of a silver dollar
69 2021-01-07 chest pain symptoms:chest and stomach pain Has markedly elevated liver function tests that were normal 2 weeks... Read more
symptoms:chest and stomach pain Has markedly elevated liver function tests that were normal 2 weeks prior to immunization Is being admitted the hospital to monitor liver function test.
69 2021-01-11 lightheadedness, anaemia, haemoglobin decreased, haemoglobin decreased, lightheadedness, anaemia Moderna COVID-19 Vaccine EUA About 30 minutes after receiving the vaccine she felt dizzy and lighthe... Read more
Moderna COVID-19 Vaccine EUA About 30 minutes after receiving the vaccine she felt dizzy and lightheaded and felt like she was going to pass out. She is a type II diabetic but they did not have any ability to check her blood sugar at employee health. Therefore, rapid response team was called and patient was brought here to the emergency department. Patient notes that she has had a couple of syncopal episodes in the past in her life and has had several near syncopal episodes. Upon arrival to the ED her blood sugar was noted to be 99. She is feeling little bit better but still just a little bit dizzy. She was completely and entirely asymptomatic prior to getting the vaccine shot. She has not been ill lately. BP 116/68 | Pulse 62 | Temp 36.7 °C (98.1 °F) (Oral) | Resp 15 | Ht 1.524 m (5') | Wt 229 lb 8 oz (104 kg) | SpO2 100% | BMI 44.82 kg/m² 69-year-old female presented to the emergency department following a near syncopal episode after getting her COVID-19 vaccine. She is normotensive, not tachycardic, tachypneic or hypoxic. She has a normal physical exam and normal cardiopulmonary exam. Lab work-up shows a mild chronic anemia with a hemoglobin of 9.9. BMP, chest pain panel normal. EKG was normal. Patient was kept on cardiac monitoring and given oral fluids. We then got her up and she was ambulatory without symptoms and without difficulty. Therefore, this appears to be a vasovagal near syncopal episode that has resolved. Work-up here is negative. No further work-up is indicated. Will discharge home, rest, fluids, cautioned her that she might feel poorly for a day or 2. Follow-up with primary care as needed. Return for worsening symptoms.
69 2021-01-14 heart rate increased No immediate adverse effects noted on 1/13/21. Patient was tired on the morning of 1-14-21.Her pulse... Read more
No immediate adverse effects noted on 1/13/21. Patient was tired on the morning of 1-14-21.Her pulse was noted to be 106 at approx. 7:30am. She had a 10 minute tonic clonis seizure at approx. 8:15am. She was post ictal until 10:30 am. After the seizure, her O2 was 90% and she was noted to have a temp of 100.4. She was also very tired and confused.She went to ER by ambulance approx. 8:45am and they did a CT, Labs and a urine analysis. No significant findings reported. She returned to the residence at 4:37pm on 1-14-21 and was on vitals every 4 hours. Her vitals have returned to baseline.
69 2021-01-14 hypertension Patient began to feel flushed in her legs and feeling spread to her chest and arms after approximate... Read more
Patient began to feel flushed in her legs and feeling spread to her chest and arms after approximately 5 minutes. Patient was assessed and found to be slightly hypertensive but no other abnormal vital signs. Patient felt comfortable contacting her doctor and leaving the facility on her own.
69 2021-01-15 oxygen saturation decreased, blood pressure increased, blood glucose increased Decrease O2 Increased blood sugar Increased b/p Increased short. Of breath
69 2021-01-17 fainting 3 days later had an episode of faintness, as if I stood up quickly. Vision darkened but I never pass... Read more
3 days later had an episode of faintness, as if I stood up quickly. Vision darkened but I never passed out. I was sitting and reading after eating about an hour after exercise. No further episodes.
69 2021-01-19 cardiac failure congestive My arm was a little sore after the vaccination but no other symptoms. And on 12/30 I woke up with a... Read more
My arm was a little sore after the vaccination but no other symptoms. And on 12/30 I woke up with a sever fever, vomiting and diarreah. Went to the ER and was diagnosed with CHF because my feet were so swollen and was given lasix and released. I continued to feel bad so on that Sunday 1/3 I went back to the hospital and was admitted and tested positive for COVID-19. I spent from Sun-Wed in the hospital
69 2021-01-19 chest discomfort, palpitations, chest pain Patient is a 69 y.o. female with history of multiple medical problems as indicated below including r... Read more
Patient is a 69 y.o. female with history of multiple medical problems as indicated below including rheumatoid arthritis. She is a non-smoker. She tells me she has "a heart condition" and is followed by a cardiologist. She tells me she was in her usual state of health and took her COVID-19 first vaccine today. Approximately 30 seconds later she noted chest tightness/burning that has been constant. It is rated 9/10 at maximum and improved to 5/10 after about 10 to 15 minutes. She also states, "my eyes feel funny. I feel cold. I am dizzy." She endorses palpitations and dyspnea. She denies any abdominal pain, nausea, vomiting, fevers, diaphoresis, headache, cough, rash, or syncope. She does have a history of seafood allergies and had similar reactions after eating seafood. She tells me 3 years ago after a flu shot she fainted. She tells me the past 2 years after her flu shot she had nausea or vomiting. She tells me she fell yesterday and hurt her hip but she did not hit her head. No LOC. She tells me she takes baby aspirin nightly. Family history: Mom and dad both died at age 82 from lung cancer. They both had heart disease. She was sent back from the vaccination area to urgent care to be evaluated after her reaction to the COVID-19 vaccine.
69 2021-01-20 blood pressure fluctuation, chest discomfort, chest pain, palpitations 74.7kg 69 yo WF with PMH: rheumatoid arthritis, hypothyroidism, fibromyalgia, Sjogrens Syndrome, hyp... Read more
74.7kg 69 yo WF with PMH: rheumatoid arthritis, hypothyroidism, fibromyalgia, Sjogrens Syndrome, hyperlipidemia and OSA presented to clinic for Moderna Covid19 vaccination. Patient has multiple allergies. Patient was given 0.5ml dose IM in left deltoid at ~1000. (Lot # 013L20A) Within ~30 seconds, patient complained of oral burning, chest burning 9/10, chest tightness, SOB, flushing and difficulty breathing. Patient complained of palpitations. EKG performed with no significant findings. Treated with aspirin 81mg x 4 at 1025. Described symptoms as similar to those she had in the past when exposed to seafood. Note that BP seemed unstable. EMS called to transfer to ED for rule out ACS.
69 2021-01-20 blood pressure increased, palpitations Pt received her Moderna vaccine and was advised to wait 30 minutes in observation due to history of ... Read more
Pt received her Moderna vaccine and was advised to wait 30 minutes in observation due to history of allergies. Pt reports through out her time in observation she started to feel like her heart was pounding and sweaty. EMS was called and pt was evaluated by the paramedic. Pt complained of mild shortness of breath, BP was elevated. Oxygen saturation was stable around 97%, HR was within normal limits. EMS checked pt's BS which was 120. Pt had not eaten since 12 pm. Pt reported to EMS she was starting to feel better. Pt signed a refusal with EMS as she did not want to go to the hospital. Pt was given strict instructions to call 911 if symptoms return to which the pt verbalized understanding. Pt's daughter came to clinic to drive her home.
69 2021-01-20 heart rate increased Moderna COVID-19 Vaccine EUA Dizziness, rapid heat beat, shortness of breath 20 min. after injection
69 2021-01-24 chest discomfort, heart rate increased Received shot in right arm 11:55 am. 5 minutes later I felt a cold numbness in top back shoulder. Re... Read more
Received shot in right arm 11:55 am. 5 minutes later I felt a cold numbness in top back shoulder. Reported. Nurse said keep moving arm. 30 minutes later it began a needle feeling. 35-40 minutes visible swelling in neck above clavicle and right after lips tongue numb and tight chest and rapid heart. Ambulance came treated me with Benadryl 50 mg and SolMedrol enroute to local hospital. Bp approximately 223/100 and rapid pulse. ER did EEG, ct scan head, chest X-ray, blood tests. Continuing monitoring and low potassium (never low) so treated me with iv etc. still experiencing symptoms 6 days later. Primary dr prescribed prednisone 20 mg two daily and Benadryl when needed.
69 2021-01-25 blood pressure increased, heart rate increased Extreme fatigue, ultra sensitivity to taste (salt), loss of sense of smell, Symptoms lasted approx... Read more
Extreme fatigue, ultra sensitivity to taste (salt), loss of sense of smell, Symptoms lasted approximately 36 hours. Severity believed to be that tested positive for Covid on December 24, 2020. also experience increased blood pressure and heart rate. Covid caused short term memory loss issues. The vaccination seems to cause short term memory issues and Brain fog (inability of cognitive thinking)
69 2021-01-25 palpitations Since taking the vaccine, after a few days, I continue to have nightmares, heart palpatations, sever... Read more
Since taking the vaccine, after a few days, I continue to have nightmares, heart palpatations, severe headaches, constant diarreah, lump feeling in upper chest and throat.
69 2021-01-26 heart rate increased, blood pressure increased Rapid Heart Rate, elevated B207/114 Hr 177, 10 min later 174/78 hr 92, shortly after that her her h... Read more
Rapid Heart Rate, elevated B207/114 Hr 177, 10 min later 174/78 hr 92, shortly after that her her hr increased 116 . Pt was shaking and jittery. 911 was called due to rising heart rate
69 2021-01-27 heart rate increased, blood pressure increased FELT A SWOOSH GOING THRU BODY WITHIN 5 MINUTES OF THE VACCINE, STARTED TREMBLING INSIDE AND FELT LIG... Read more
FELT A SWOOSH GOING THRU BODY WITHIN 5 MINUTES OF THE VACCINE, STARTED TREMBLING INSIDE AND FELT LIGHT-HEADED. CALLED AN EMT OVER, HE TOOK HEART RATE AND IT HAD SHOT UP 100. CAME ON HOME WITHIN AN HOUR ENDED UP AT MINOR EMERGENCY BECAUSE MY BLOOD PRESSURE HAD GONE UP TO OVER 170. HAVE HAD SHAKING INSIDE AND HIGH BLOOD PRESSURE EVER SINCE. TOOK BENADRYL, DIDN'T REALLY HELP, WENT TO MY PCP AND WAS TOLD TO TAKE CLARITIN. WAS ALSO GIVEN AT THE SECOND URGENT CARE VISIT, AMLODIPINE BUT IT DIDN'T HELP.
69 2021-01-30 chest discomfort 1/28/21 11:10 AM Sinus Headache, Fatigue 1/29/21 9:00 PM Asthma Attack - Tightness in Chest, Wheez... Read more
1/28/21 11:10 AM Sinus Headache, Fatigue 1/29/21 9:00 PM Asthma Attack - Tightness in Chest, Wheezing, Fatigue 1/30/21 1:00 AM Asthma Attack, Congestion, Fatigue 1/31/21 4:00 PM Asthma Attack - Tightness in Chest, Congestion, Fatigue Asthma treated with Albuterol inhaler Congestion treated with Theraflu Fatigue treated with rest and liquids
69 2021-01-31 chest discomfort Day of injection: Slight headache about 90 minutes after injection. Came and went. No medicine ta... Read more
Day of injection: Slight headache about 90 minutes after injection. Came and went. No medicine taken. Wave of nausea lasting about 15 minutes later in the evening. 2nd day: Arm soreness. Feeling in my chest as though I needed to take a deep breath, on and off throughout the day. Heart rate fine, blood pressure good (125/70 average), blood oxygen 97-99 all day, evening. 3rd day: arm soreness diminished. No other side effects.
69 2021-01-31 heart rate increased A few minutes after receiving her vaccine, the patient complained of nausea, rapid heart rate (puls... Read more
A few minutes after receiving her vaccine, the patient complained of nausea, rapid heart rate (pulse was 97), shivering and dizziness. We continued to observe her for 25 minutes at which time her symptoms did not improve and 911 was called at the request of her husband. EMS then transported patient to the hospital.
69 2021-01-31 fast heart rate Fever to 102.4. Chills. Shaking. Generalized body aches. Injection site pain down arm. Tachycard... Read more
Fever to 102.4. Chills. Shaking. Generalized body aches. Injection site pain down arm. Tachycardia of 120 beats per minute. Pulse ox was 96%. Weakness. Nause
69 2021-02-01 blood pressure decreased Anaphylactic type reactions such as dizziness, cough and throat swelling, BP drop - happened slowl... Read more
Anaphylactic type reactions such as dizziness, cough and throat swelling, BP drop - happened slowly within 1 hour with antihistamines taken 1 hour prior to injection ( Chlorphenerimine 4 mg, Pepcid 20 mg tabs) Swelling of feet, hands, face in 1.5 hours. Used Flucatisone nasal spray x2 , albuterol puffs x 2 and pseudophed 15 mg tablet Continued to use Antihistamines for 3 - 4 days post injection for rash and swelling. VERY FATIGUED for 3 days. Rash over trunk of body for 7- 10 days post injection
69 2021-02-01 chest discomfort Changes in hearing, faint, aches in hips and neck, tight chest. Faintness was within 10 minutes of a... Read more
Changes in hearing, faint, aches in hips and neck, tight chest. Faintness was within 10 minutes of administration of vaccine. And last about 2-3 minutes. Aches lasted 2 days. Ears felt strange next day: felt as if plugged, seemed both like a loss of hearing and exaggerated hearing at same time. Roaring in ears.
69 2021-02-01 heart rate increased Flushing in face, rapid heart rate
69 2021-02-03 cardiac arrest, cardio-respiratory arrest Pt presented to the emergency department with complaints of myalgias after receiving the vaccine. Sh... Read more
Pt presented to the emergency department with complaints of myalgias after receiving the vaccine. She noted that she had vomiting the night prior. She denied any chest pain, shortness of breath, abdominal pain, headaches, fever at that time. Pt was left in room by herself for approximately 5 minutes and was found unresponsive. Code Blue was called. Pt was found in asystole. ACLS was initiated. Return of circulation occurred after 7 minutes of resuscitation. Pt is currently intubated and sedated.
69 2021-02-03 chest discomfort Anaphylactic shock; Potassium "dropped to 1%"; Cold and numb sensation; Sweating; Chest pressure; Bl... Read more
Anaphylactic shock; Potassium "dropped to 1%"; Cold and numb sensation; Sweating; Chest pressure; Blood pressure was 223/105-110; Neck swelling; Numb lips; Throat swelling; Disability NOS; A spontaneous report was received from a 69-year-old, female, patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced anaphylactic shock, potassium dropped to 1%, cold and numb sensation, sweating, chest pressure, blood pressure was 223/105-110,Neck swelling, Throat swelling, Numb lips and disability. The patient's medical history, as provided by the reporter, included allergies to yellow 5 (tartrazine), shellfish, and bee stings. Concomitant product use was not provided by the reporter. On 19 Jan 2021 at 11:42 AM, approximately two minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, minutes after receiving the vaccine, the patient experienced a cold and numb sensation on the upper right part of her back. The sensation extended around her shoulder and into her clavicle region. Approximately 30 minutes after vaccination she started sweating and felt like she was going into anaphylactic shock, which she had experienced in the past. The patient felt like her throat was swelling and her neck started to visibly swell. One hour after vaccination, the patients lips went numb, the clavicular numbness continued, and she started to experience chest pressure. A paramedic then evaluated the patient, her blood pressure was 223/105-110 mmHg, she was placed in an ambulance, given diphenhydramine and solumedrol, then taken to the emergency room. At the emergency room, the patient received a chest x-ray, computed tomography scan, blood tests, and an electrocardiogram. Previously, the patient had a blood test which showed a potassium of 4.3 to 3.9 "or something." At the emergency room, her potassium had "dropped to 1%." The patient was administered potassium in the hospital and was held for observation until approximately 10:00 PM, then discharged. On 20 Jan 2021, the patient continued to experience chest tightness. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events anaphylactic shock, potassium dropped to 1%, cold and numb sensation, sweating,blood pressure was 223/105-110 ,Neck swelling, Throat swelling, Numb lips and disability was unknown. The event, chest pressure was considered not resolved.; Reporter's Comments: This case concerns a 69-year-old, female patient with medical history of allergies to yellow 5 (tartrazine), shellfish, and bee stings, who experienced a serious, unexpected event of anaphylactic shock, sweating, hypoaesthesia, pharyngeal swelling, neck swelling, numb lips, chest discomfort, hypertension, hypokalemia and disability NOS. The event occurred the day the first dose of mRNA-1273 was administered. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
69 2021-02-04 chest discomfort, chest pain Face flush and hot Throat, chest burning Slight tightness in throat and chest Took Benadryl and Pep... Read more
Face flush and hot Throat, chest burning Slight tightness in throat and chest Took Benadryl and Pepcid Burning went away before taking benedril in about 45 min. Flush face remained about 2 hrs after taking Benadryl. Tightness in chest subsided after taking Benadryl. Continuing with Benadryl every 6 hrs for 5 days, Pepcid 2x/ day 5 days.
69 2021-02-04 skin turning blue 1. 8 to 9 hours after administration:severe chills and body shaking, hands turned blue. 2. 1 hour l... Read more
1. 8 to 9 hours after administration:severe chills and body shaking, hands turned blue. 2. 1 hour later, severe nausea, stomach cramps 3. 1 hour later, tingling of hands
69 2021-02-07 hypertension, loss of consciousness Brain aneurysm; Anaphylactic reaction; Collapsed; BP sky rocketed; Shortness of breath; A spontaneou... Read more
Brain aneurysm; Anaphylactic reaction; Collapsed; BP sky rocketed; Shortness of breath; A spontaneous report was received from a consumer concerning a 69-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced blood pressure skyrocketed, shortness of breath, loss of consciousness, massive anaphylactic reaction, and brain aneurysm. The patient's medical history, as provided by the reporter, included high blood pressure and arthritis. Products known to have been used by the patient, within two weeks prior to the event, included an antihypertensive. On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. Twenty-two minutes later she had a massive anaphylactic reaction. She experienced shortness of breath, blood pressure skyrocketed, and loss of consciousness. She was taken to the emergency room. The patient had a brain aneurysm and never recovered. No treatment information was provided. The patient died on 04 Jan 2021. The cause of death was reported as brain aneurysm. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 69-year-old, female patient with a medical history of hypertension, who experienced fatal, serious, unexpected events of Anaphylactic reaction, hypertension, dyspnea, loss of consciousness and brain aneurysm. The events occurred 22 minutes after the first dose of mRNA-1273 was administered. No treatment information was provided. The patient never recovered and died. The cause of death was reported as brain aneurysm. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.; Reported Cause(s) of Death: Brain aneurysm
69 2021-02-07 palpitations nausea, vomiting, dizziness, palpitations, sweating, weakness, light headness, aches and pains, inab... Read more
nausea, vomiting, dizziness, palpitations, sweating, weakness, light headness, aches and pains, inability to focus, weakness
69 2021-02-08 loss of consciousness Patient states she received the Moderna second vaccine around noon. Around 2 am she sent and drank ... Read more
Patient states she received the Moderna second vaccine around noon. Around 2 am she sent and drank some warm milk. As she walked up the stairs, she felt like vomiting and also felt like she could not move. Tried to crawl to the bathroom when she passed out. woke up with clothes full of vomit. Feeling better today.
69 2021-02-08 platelet count decreased Fever, confusion, sepsis, hospitalized
69 2021-02-09 hypertension Patient here for COVID-19 vaccine. Stated she had had a reaction to bee pollen in the past but was n... Read more
Patient here for COVID-19 vaccine. Stated she had had a reaction to bee pollen in the past but was not concerned. She had done well with vaccine #1 and stayed for 15 min. at that time. Vaccine was given at 1335. Pt re-evaled 15" after her #2 dose, She felt dizzy had had a high BP 191/81. Pt was advised to go to the ER and was taken by car up to the hospital at 1338, accompanied by a staff member. Upon transport to the ED patient complained of sore throat. Epipen was administered in the ED and patient was monitored for 75 minutes. Blood pressure returned to baseline and patient report feeling like her usual self with the exception of feeling a little jittery due to the EpiPen.
69 2021-02-09 hypotension On 4th day after vaccination, experienced dizziness and very low blood pressure. Normal Blood pressu... Read more
On 4th day after vaccination, experienced dizziness and very low blood pressure. Normal Blood pressure is around 112/65. Blood pressure during the dizziness event (today) was measured as 97/62. I suffer from Hypertension and take Amlodipine Besylate 10 mg/day, which lowers the BP to normal. I have continued to take the Amlodipine Besylate after vaccination. I have not has any additional adverse side effects from the vaccination. Seven hours after the vaccination on February 4th, blood pressure was measured as 105/61. On Feb 5th, the BP was measure at 122/72. On Feb 7th, the BP was measured at 101/63. The day (February 9th) started with extreme fatigue and the feeling of not having slept well (I had 9.5 hours of sleep). No other symptoms except the dizziness. SPO2 measured at 98/99 % and PI was 5.4. RR was 19/minute. Oral temperature has been normal at 98.0 (normal for me).
69 2021-02-09 palpitations heart racing, sore arm
69 2021-02-10 blood pressure increased Elevated B/P, Headache; Anxiety; Refused to go to the hospital
69 2021-02-10 heart rate increased 12 hours post vaccine, onset of headache, extreme fatigue, fever up to 100.3°, body aches, heart ra... Read more
12 hours post vaccine, onset of headache, extreme fatigue, fever up to 100.3°, body aches, heart rate up to 130bpm, and severe chills. Day after, chills subsided, temp and heart rate gradually back to normal. Day 2 almost normal
69 2021-02-10 pallor Felt a bit ill the day of the shot. Tried to help do dinner later that day and turned white and swe... Read more
Felt a bit ill the day of the shot. Tried to help do dinner later that day and turned white and sweaty and had to sit down for about 15 minutes. The next day injection site began to swell. By the 8th day post injection it was hard to the touch, about the size of a large marshmallow and hard to the touch. No skin discoloration, but felt warm to touch and very itchy. Used Lanacanevto stop the itch. Today the 11th, most of swelling is gone and just a little tender to touch. Did not contact anyone medical about this, but a friend said i should report it.
69 2021-02-10 palpitations 2 days after vaccination, patient developed intermittent dry cough and palpitations that are worseni... Read more
2 days after vaccination, patient developed intermittent dry cough and palpitations that are worsening. Has not been diagnosed with COVID-19 prior.
69 2021-02-11 chest pain Chest pain, nausea, chills, aches
69 2021-02-11 chest pain Numbness on face and lips left side. Strong metallic taste in mouth. Immediate swelling injection ... Read more
Numbness on face and lips left side. Strong metallic taste in mouth. Immediate swelling injection site and in arm pit of left arm. Stiffness in right leg, left arm. Brief Pain (as heartburn but sharper) in center chest Stiffness in neck.
69 2021-02-11 palpitations, heart rate irregular Woke up at 1:00 AM with heart pounding and beating very fast, dizzy, chills followed by high fever. ... Read more
Woke up at 1:00 AM with heart pounding and beating very fast, dizzy, chills followed by high fever. This lasted 2+ hours. Then my heart beat so faintly, that I was afraid to go back to sleep for fear I would not wake up. Felt a little sick to my stomach. Next day, I felt like I had the flu all day, lethargic, tired but couldn't sleep. The injection site of the shot was very sore, big red circle about the size of a peach, hot to the touch and this lasted until day 5. Concerned about 2nd dose, because if the reaction was worse than this, I don't think my heart can take it.
69 2021-02-11 fainting syncope (in setting of chills) about 12 hrs after vaccine given
69 2021-02-13 chest discomfort At first just a sore arm. But the next night, started running fever and got chills. Also had sore ... Read more
At first just a sore arm. But the next night, started running fever and got chills. Also had sore throat, rawness in chest, particularly in bronchial area, was short of breath and very tired. Fevers were intermittent but recurring several times a day and then temp would drop back to normal. Chest symptoms worsened with each day. SEVEN DAYS AFTER THE INJECTION, I developed a large red welt on the arm, about 3 inches in length. Fever/chills/sore throat/swollen glands lasted TWO WEEKS AND A DAY. Red welt lasted 8 days. I am still tired and have a swollen lymph node under my left arm (the arm that was injected). I NEED ADVICE ABOUT WHETHER TO GET A 2ND DOSE!! Can someone please contact me??
69 2021-02-13 heart rate increased, palpitations, fast heart rate Patient received the vaccine Thursday morning around 10AM. Twelve hours later developed chills, swea... Read more
Patient received the vaccine Thursday morning around 10AM. Twelve hours later developed chills, sweats, fever 101, headache, nausea, shortness of breath, dizziness and palpitations described as rapid heart beat. She was treated with isotonic fluids and with symptom resolution. Patient was discharged home in improved and stable condition.
69 2021-02-14 platelet count decreased, haemoglobin decreased Patient complained of sore tongue and tingling and burning sensation over all skin surface. No rash ... Read more
Patient complained of sore tongue and tingling and burning sensation over all skin surface. No rash however. Starting several days after vaccine administration
69 2021-02-14 fainting, loss of consciousness According to her husband, approximately 3 hours after vaccine, patients clasped and was instantly un... Read more
According to her husband, approximately 3 hours after vaccine, patients clasped and was instantly unconscious. She was pronounced dead upon arrival to hospital and physician told husband that she had suffered a burst abdominal aneurysm and passed immediately. Nothing was out of ordinary during vaccination and during 15 minute wait time after.
69 2021-02-15 blood pressure increased, chest pain Elevated Blood pressure outside of normal range at 220/110. Have gone to the ER three times due to C... Read more
Elevated Blood pressure outside of normal range at 220/110. Have gone to the ER three times due to Chest pain and severe elevated blood pressure. New medications started include Amlodipine, ASA, Rosastatin.
69 2021-02-15 blood pressure increased 1100 Post vaccination reports dizziness w/no additional or associated symptoms Medical monitoring x ... Read more
1100 Post vaccination reports dizziness w/no additional or associated symptoms Medical monitoring x 30 min, fluids offered, vitals assessed w/noted BP elevation 170/85 Reports "feels better" post rest and hydration , plan to f/up PMD due to elevated BP; released from facility.
69 2021-02-15 chest pain, palpitations Patient states she started experiencing heart palpitations and chest pain shortly after receiving th... Read more
Patient states she started experiencing heart palpitations and chest pain shortly after receiving the vaccine dose
69 2021-02-17 palpitations The day after the injection I experienced shortness of breath and a pounding heart, especially going... Read more
The day after the injection I experienced shortness of breath and a pounding heart, especially going upstairs. After several days, it became so severe that I had to lie down to catch my breath after climbing stairs or doing anything remotely strenuous. It would resolve itself after a few minutes of rest. It continued for 6 days and then stopped on the 7th day. I felt fine the day of the injection. I plan to follow up with my primary doctor. As of now, it appears to be completely resolved but I will not take the second dose for fear of a bad reaction.
69 2021-02-19 blood pressure increased Patient reported her mouth was dry, her throat closed up and it was difficult to breathe 30 minutes ... Read more
Patient reported her mouth was dry, her throat closed up and it was difficult to breathe 30 minutes after getting the Moderna vaccine. Her husband drove her to the fire station near her home where she was monitored for a couple hours. They told her to drink lots of water and breathe through her nose. They monitored her vitals. She reported increased blood pressure and heart rate and low oxygen.
69 2021-02-20 cerebral haemorrhage Had Moderna COVID vaccine approximately 1pm on 2/17. Developed headache and right visual field loss ... Read more
Had Moderna COVID vaccine approximately 1pm on 2/17. Developed headache and right visual field loss approximately 8pm on 2/18. Presented to our hospital at 5pm on 2/19 with progression of aforementioned symptoms and found to have left intraparenchymal hemorrhage with midline shift. Her symptoms are currently stable. Our neurosurgical team is not planning any surgical intervention. MRI of her brain demonstrates potential amyloid deposits, which are likely causative.
69 2021-02-20 hypotension, oxygen saturation decreased, loss of consciousness Eighteen hours afterwards, I kept passing out. Blood pressure and oxygen were low. Stayed on bipap. ... Read more
Eighteen hours afterwards, I kept passing out. Blood pressure and oxygen were low. Stayed on bipap. Poor vision, severe weakness. Slurred speech. Took 120 my mestinon, fluids. regained vision and awareness. Couldn?t stay awake until 6 hours later. Second day, weakness and short of breath. I should have gone to ER, but need mestinon and fluids. Cannot speak. Felt safer still home. Very confused.
69 2021-02-21 atrial fibrillation about 10 days after receiving the vaccine started with new onset A. Fib and shortness of breath esp... Read more
about 10 days after receiving the vaccine started with new onset A. Fib and shortness of breath especially on exertion. I am in work up for same Holter monitor, ECHO, ETT and f/u with cardiology
69 2021-02-21 fainting Patient was admitted after having a syncopal episode. After evaluation by cardiology and neurology, ... Read more
Patient was admitted after having a syncopal episode. After evaluation by cardiology and neurology, patient was discharged
69 2021-02-22 loss of consciousness Without showing any side effect symtoms, patient suddenly fell unconscious and passed away within an... Read more
Without showing any side effect symtoms, patient suddenly fell unconscious and passed away within an hour. Though 911 was called and Paramedic was trying to revive the patient.
69 2021-02-23 blood glucose increased Patient waited 15 minutes after vaccine. Patient left building and started to c/o chills and 'felt ... Read more
Patient waited 15 minutes after vaccine. Patient left building and started to c/o chills and 'felt like she was going to pass out' in vehicle. Patient complained of headache and 'labored breathing'. Brought back into building and placed on 0 2 via N/C. Ambulance called for transport to local ED. Epi given by EMS. Pulse ox 97 %. History of allergy to Bee Stings. PMH -diabetes. Patient provided Benadryl in ED, blood sugar elevated. held in ED for ~ approximately 4 hours and released to home.
69 2021-02-23 heart rate increased pain neck shoulders head, dehydration, electrolytes, elevated heart rate, vomiting, fever
69 2021-02-23 pallor On 2/22 area became itchy, noticeable darker red in color and area of erythema extended further down... Read more
On 2/22 area became itchy, noticeable darker red in color and area of erythema extended further down arm from deltoid area. Tuesday area wider and extended further down arm, more itchy. Wednesday am area again extending somewhat further down from earlier measured area . At no time was area warm to touch. painful to touch( area sore first 36 hrs post injection), area blanches, a febrile.
69 2021-02-25 blood pressure increased Felt normal side effects for 24 hours . 3 days later started with weakness, diarrhea , slight fever.... Read more
Felt normal side effects for 24 hours . 3 days later started with weakness, diarrhea , slight fever. 5 days later having bouts of weakness, not able to think clearly an BP was elevated to 160/90. Now for 2&1/2 weeks symptoms continue up till today when almost passed out, BP190/99. Feel terrible. Have apt next week with my Dr. Getting scary.
69 2021-02-25 blood pressure increased Patient states with in 5 minutes she felt an odd sensation across her body. She was dizzy and sleep.... Read more
Patient states with in 5 minutes she felt an odd sensation across her body. She was dizzy and sleep. She waited for 30 minutes at the pharmacy and then proceeded home. She states at home within an hour her blood pressure spike to 151/85 and had a dull headache. She has itchyness at the site of injection. She was sleepy but could not sleep at night and still had a dull headache in the morning.
69 2021-02-25 nosebleed Patient reported epistaxis (nose bleed). It was noticed by patient approximately 90 minutes post vac... Read more
Patient reported epistaxis (nose bleed). It was noticed by patient approximately 90 minutes post vaccination, as blood inside her mask.
69 2021-02-25 palpitations 36 hours later, (approximately), I woke up with a rash. Under the both arms it looked like a sunburn... Read more
36 hours later, (approximately), I woke up with a rash. Under the both arms it looked like a sunburn. Across the chest an sides, it was spotty. The right side had more rash than the right, and both sides wrapped around to the back, about 2 inches, on both sides. Less going down the rest of the torso. Took Benadryl, 2-25 mg, 4 hours apart, for a total of 100 mg. 1:00PM, Feb. 26, rash faded significantly. Also had a dry mouth and a bit of a racing heart, right after being given the vaccination & again when the rashes appeared. However, this could have been anxiety. Both times it went away after walking & deep breathing. Lasted for about 15 minutes each time.
69 2021-02-26 chest pain I woke up during night after vaccine, and couldn't move on my whole right side of body. Extreme pain... Read more
I woke up during night after vaccine, and couldn't move on my whole right side of body. Extreme pain in joints and muscles. My chest was in the same pain. The next morning it got better but still have symptoms. Aching and tingling in legs and aching in shoulders.
69 2021-02-26 pallor One week after I received the 1st dose of the Moderna CoVid-19 vaccine, I developed a bright pink, ... Read more
One week after I received the 1st dose of the Moderna CoVid-19 vaccine, I developed a bright pink, hard, raised area of very itchy rash at the site of the injection. It was about 2"x3" in size, was very warm and painful to the touch. The size increased over the next couple of days to about 3" in diameter but decreased in symptoms (less pain, less itch, less hard, less raised and less warm). I still have the sensitive area today (Saturday, Feb 27, 12:33 pm) but it has continued to decrease in symptoms. The affected area is still about 3" in diameter but has faded in color (now pale pink).
69 2021-02-27 skin turning blue Large black and blue mark about 4" wide and 1" - 2" high. And, a red mark below it. Some swelling,... Read more
Large black and blue mark about 4" wide and 1" - 2" high. And, a red mark below it. Some swelling, warmness, and itching at the site. A little fatigue. A little nausea.
69 2021-02-27 heart rate irregular, heart rate increased, atrial fibrillation Heart went into fast BPM and irregular rhythm on2/07/2021. Stayed in Afib Until 02/18/2021 with sp... Read more
Heart went into fast BPM and irregular rhythm on2/07/2021. Stayed in Afib Until 02/18/2021 with spontaneous conversion.
69 2021-02-28 chest discomfort Chest pressure, shortness of breath, numbness of lips, throat tight/ache. Red splotchiness on arms. ... Read more
Chest pressure, shortness of breath, numbness of lips, throat tight/ache. Red splotchiness on arms. Lasted about 20 minutes then slowly improved. Breathing back to normal after 45 minutes.
69 2021-02-28 palpitations I experienced symptoms commonly indicated as possible side effects: arm soreness, headache, low-grad... Read more
I experienced symptoms commonly indicated as possible side effects: arm soreness, headache, low-grade fever, chills, and nausea. I also experienced an intensification of my chronic back pain. In addition I experienced about 20 hours of intense heart pounding with moderate labored breathing/shortness of breath. This is what I am identifying as the adverse event.
69 2021-02-28 palpitations Began not feeling well about 8 hours after my shot. That night I developed a fever (under 100 degree... Read more
Began not feeling well about 8 hours after my shot. That night I developed a fever (under 100 degrees) and chills. Had some heart palpitations. Next day I still had a slight fever, general malaise, soreness from shot in arm, a few occurances of heart palpitations, sore back. On third day, no fever, but still felt under the weather, with a sore arm plus some hardness in the injection area. Had some palpitations that evening. By the 4th day, felt better in general, but began feeling a very slight numbness on lips and surrounding facial area. Arm still sore with hardness. Better on 5th day. Day 8 & 9 had pains in lower shins. Day 9 I noticed tiny small bumps on upper front and back shoulders and upper arms. They were not hive like and some were itchy. Took some Benadryl that night which didn't reallly help. Days 10-12 - still have tiny bumps some slightly pink, mostly skin tone, spreading to neck area. Saw my internist on 2/25/21 Day 14 to ask if symptoms related to vaccine shot. He didn't think the rash was related because it didn't start away after shot. The continuing ever so slight numbness in lips and surrounding area may be just from anxiety, he said. 3/1/21 - still have occasional slight numbness off and on of lips with "grainy" rash still present.
69 2021-03-01 palpitations, blood pressure increased, heart rate increased Approximately 20 hours later I developed fever that climbed to 101.6. Took 500mg Tylenol. Fever aba... Read more
Approximately 20 hours later I developed fever that climbed to 101.6. Took 500mg Tylenol. Fever abated. 24-36 hours after vaccine, I developed heart palpitations, high heart rate, increased blood pressure Visited primary care doctor and had EKG. Confirmed abnormal EKG, referred to cardiologist. Appointment on 3/4/21. Heart symptoms consistent until two weeks post vaccination, 3/2/21. Heart symptoms seem to be easing. No previously known heart problem or high blood pressure.
69 2021-03-02 loss of consciousness 2nd dose of Moderna at 9:00am. No side effect (except pinch at injection site) throughout the day an... Read more
2nd dose of Moderna at 9:00am. No side effect (except pinch at injection site) throughout the day and evening. At ~9:45pm, my wife suddenly fell unconscious. Immediate CPR & with Paramedic were not able to revive her. SHE PASSED AWAY at home. We believe it may be triggered by the vaccine. Did not have a chance to go to hospital or emergency room - it was too sudden. A sad day for us.
69 2021-03-03 chest pain Chest burning sensation anterior chest. NOT reflux, heart burn, abdominal pain, coughing, wheezing, ... Read more
Chest burning sensation anterior chest. NOT reflux, heart burn, abdominal pain, coughing, wheezing, rash. It was a burning in anterior chest sensation per patient
69 2021-03-03 chest pain Patient presented to ED with chest pain radiating to the back, as well as left arm numbness, and lig... Read more
Patient presented to ED with chest pain radiating to the back, as well as left arm numbness, and lightheadedness. Patient was placed in observation unit - serial troponin negative, CTA showed no PE, mild ectasia of the distal ascending thoracic aorta. She was advised to follow up with PCP and cardiology for outpatient stress test. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
69 2021-03-03 fainting Moderna Covid 19 vaccine EUA - chills, headache, dizziness(causing me to faint)
69 2021-03-04 fainting Light headed. hot & cold flashes, muscle cramps, fainting spell and headache.
69 2021-03-05 heart rate increased 69 years old female complaint of increasing heart rate.
69 2021-03-05 hypertension Woke up at 4am the next morning with a wave of dizziness. When I got up around 8 , I was very dizzy... Read more
Woke up at 4am the next morning with a wave of dizziness. When I got up around 8 , I was very dizzy and my blood pressure was 174/118. I called my primary around 8:15am and was instructed to go to their walk in clinic. When I got there they took my blood pressure , which was high. They asked why I didn't take the Clonidine and I replied I didn't know. They proceeded to do a EKG. The PA came back and informed me that it was different from one that was taken in January. He proceeded to call my heart doctor which wanted to see me at 11. The PA also ordered a ct scan of my head at1:30 that afternoon. I saw the Heart Doctor around 12 {he was delayed}. They took at least 3 EKG's while I was waiting for him. He has ordered a stress test for next Thursday. The PA has ordered a carotid artery ultra sound for tuesday. My blood pressure had been normal for the last three months (I forgot to mention). Yesterday, the 5th of March I was still dizzy, but not quite as bad. The pa had ordered Mecizine 25mg for the dizziness.
69 2021-03-05 palpitations HOT FLUSHES FROM HEAD DOWN BODY, HEART RACING, NAUSEA.
69 2021-03-06 blood pressure increased s/p vaccine, c/o nausea, shakiness. BP slightly elevated then returned to normal. Sx resolved withou... Read more
s/p vaccine, c/o nausea, shakiness. BP slightly elevated then returned to normal. Sx resolved without intervention
69 2021-03-06 hypertension patient had immediate left eye vision blurring with hypertension. No known history of hypertension. ... Read more
patient had immediate left eye vision blurring with hypertension. No known history of hypertension. The blurred vision resolved in about 40 minutes, the hypertension did not resolve
69 2021-03-07 chest discomfort, fast heart rate ASTHMA ISSSUES AND TACHACARDIA LASTING 4-5 HORSHRT RATE BETWEEN 118--130, HEAVINES IN CHEST
69 2021-03-08 blood glucose increased, chest pain extreme shortness of breathe burning sensation in chest lasted 6 days unable to climb 1 flight of st... Read more
extreme shortness of breathe burning sensation in chest lasted 6 days unable to climb 1 flight of stairs in house without resting, disorientation 2 days light headed and dizzy with painful headache lasting 4 days bedridden by headache and disorientation chills no fever but body aches high blood glucose readings 5 days
69 2021-03-08 body temperature decreased Day 1= Vaccination Day 1. Day 1. Extreme Facial Flushing/Hotness 20 min post administration. Durat... Read more
Day 1= Vaccination Day 1. Day 1. Extreme Facial Flushing/Hotness 20 min post administration. Duration 5 min. No recurrence. 2. Day 1. Drop in body temperature. 95.2°F recorded 5 hrs post vaccination and continued 4 days. 3. Day 3. Bruise and knot at injection site and pain radiating from knot down into thumb. Fatigue.
69 2021-03-08 loss of consciousness Unconscious; Felt a bit sore at the injection site; A spontaneous report was received from a consume... Read more
Unconscious; Felt a bit sore at the injection site; A spontaneous report was received from a consumer and healthcare facility staff member concerning a 69 years old, female patient who experienced little bit sore at the injection site, unconscious and passed away. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. The patient experienced sore at the injection site and unconsciousness both since 22 Feb 2021. The husband of the patient performed CPR as instructed by 911 and EMT's and police performed medical procedure which included injections and electrical shock both on 22 Feb 2021. The patient died on 22 Feb 2021. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The patient died on 22 Feb 2021. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter's Comments: This is a case of death of a 59-year-old, female patient who experienced injection site sore and became unconscious on the same day after mRNA-1273 administration and subsequently expired. Although critical details such as the patient's medical history and actual cause of death is lacking, based on the current available information which shows a strong temporal association with the product use, thus, a causal relationship cannot be excluded. injection sore is consistent with product safety profile and cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death
69 2021-03-08 fainting Feeling faint; Light headed; Fatigue; Diarrhea; Nausea; Vomited; Sore arm; A spontaneous report was ... Read more
Feeling faint; Light headed; Fatigue; Diarrhea; Nausea; Vomited; Sore arm; A spontaneous report was received from a consumer concerning a 69-Years old, female patient who experienced the events syncope, dizziness, pain in extremity, diarrhoea, nausea, vomiting and fatigue. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included metformin for diabetes type 2, valsartan 25mg for high blood pressure and paroxetine for anxiety and depression. On 09 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient experienced sore arm. On 11 Feb 2021, the patient felt very bad had nausea and vomited. The patient also experience diarrhea on the same day. On 12 Feb 2021, the patient woke up with feeling faint and lightheaded. The patient reported that she cannot put anything in their mouth and experienced fatigue. The event syncope was considered to be serious with seriousness criteria - medically significant and all other events were non-serious. Action taken with mRNA-1273 in response to the events was not unknown. The outcome of the events syncope, dizziness, pain in extremity, diarrhoea, nausea, vomiting and fatigue was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
69 2021-03-09 chest discomfort Difficulty Breathing; Chest Tightness; allergic reaction; A spontaneous report was received from a H... Read more
Difficulty Breathing; Chest Tightness; allergic reaction; A spontaneous report was received from a Healthcare Professional concerning a 69-years-old female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced events difficulty breathing and chest tightness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29 Jan 2021, immediately after the first dose, the patient experienced the events difficulty breathing and chest tightness. Treatment details included, Benadryl - Given by the ER HCP to alleviate the allergic reaction to the Moderna COVID-19, Vaccine. The events of difficulty breathing and chest tightness were considered to be serious with criteria of life threatening. Action taken with mRNA-1273 in response to the events was unknown. On 29 Jan 2021 the outcome of events difficulty breathing and chest tightness was resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
69 2021-03-09 fainting Got home Felt nauseous. Went into the bathroom and passed out and fainted and hit her head as she p... Read more
Got home Felt nauseous. Went into the bathroom and passed out and fainted and hit her head as she passed out
69 2021-03-10 blood glucose increased I woke about 8 hrs after injection with bad headache and very sore all over. Hands and bottoms of f... Read more
I woke about 8 hrs after injection with bad headache and very sore all over. Hands and bottoms of feet on both sides felt like shards of glass were poking me all over. Slept nearly all day and all night the next night. My blood sugar was extremely high on the morning of the 2nd day. (310) That has never happened before.
69 2021-03-10 blood pressure increased elevated blood pressure 188/87 noted within the first 24-48 hours blood pressure continued to be wel... Read more
elevated blood pressure 188/87 noted within the first 24-48 hours blood pressure continued to be well above baseline for several days, gradually approaching normal by 10-12 days increased anxiety over blood pressure being so elevated
69 2021-03-10 chest pain Pt developed shortness of breath, itchiness in her throat, and chest pain 15 minutes after receiving... Read more
Pt developed shortness of breath, itchiness in her throat, and chest pain 15 minutes after receiving her first dose of the moderna vaccine. Pt received 0.3mg epinephrine, 50mg benadryl. She did not initially improve. 0.5mg epinephrine was given, along with 40mg methylprednisolone. Pt was transported to the emergency department where she remained for 5 hours in observation. She received medication in the ER. She was discharged home. She is now experiencing generalized fatigue.
69 2021-03-10 heart rate increased Within a few hours of vaccination I had mild symptoms; sore arm, bone ache, rapid heartrate (briefly... Read more
Within a few hours of vaccination I had mild symptoms; sore arm, bone ache, rapid heartrate (briefly), strange hallucinating dream. Seven days following the injection, arm became sore again, developed rash, hot, sore to touch and movement.
69 2021-03-10 loss of consciousness, palpitations fever 102, chills, vomit, dizzy, passing out, severe headache, heart racing, lasted 2 days, finally ... Read more
fever 102, chills, vomit, dizzy, passing out, severe headache, heart racing, lasted 2 days, finally after second day could hold down water and tiny bit of toast fever of 99-100 lasted 2 more days, still hard to hold down anything. On day 6 still weak, shaky feeling bad. This sucks!
69 2021-03-10 pulmonary embolism, troponin increased, fast heart rate Developed tachycardia and shortness of breath on 3/1/21 which was significantly worse on 3/2/2021. ... Read more
Developed tachycardia and shortness of breath on 3/1/21 which was significantly worse on 3/2/2021. Went to ER and CT angio showed diffuse bilateral pulmonary embolism. Spent the night for heparin, telemetry monitoring and lab work.
69 2021-03-12 chest discomfort Patient had received Moderna #2 vaccine. Waited at vaccine center for 15 minutes and felt fine. Wh... Read more
Patient had received Moderna #2 vaccine. Waited at vaccine center for 15 minutes and felt fine. While driving home she started feeling a tightness in her chest and feeling like she could not take a full breath. They turned around and returned to the vaccine injection clinic. She was evaluated by practitioner onsite and was brought to our clinic for further observation by paramedic ambulance. At this time she says the pressure seems to be lessening. Feels she can get a full breath. States after shot #1 she felt "blah" for about 1 day. Only known allergy is thimerosal. States this caused hives when she was younger. She is on no chronic medications.
69 2021-03-12 palpitations fever, chills, severe body aches, heart racing
69 2021-03-12 blood clot superficial blood clots in left leg.
69 2021-03-13 chest discomfort About 15 minutes after receiving the injection my nose started to itch a little. It was so minor I ... Read more
About 15 minutes after receiving the injection my nose started to itch a little. It was so minor I was not concerned. By 40 minutes after the injection when at home I was itching significantly all over my body. My tongue was red, sore, and swollen. My mouth and throat were red and sore. I was having some trouble swallowing and hoarse. I developed a cough. I felt very tired and my hands, feet and face were swollen. Maybe about 50 minutes after the injection, my chest was feeling tight like the start of asthma. I used a Breo ellipta (100mcg fluticasone furoate and vilanterol 25 mcg inhalation powder.) Maybe 30 minutes later I was breathing better. As the other symptoms worsened I took benedryl by mouth.I had an epipen, but I did not use it. I awakened in the night and my joints (hands, knees, feet) were very sore and swollen. I had a mild headache and lower back ache. The other symptoms persisted except for the trouble breathing. The symptoms have, except the trouble breathing, continued throughout the day after the vaccination but milder. However the fatigue and joint pain and swollen hands, feet, and face are still moderate. I am considering taking another benedryl. I sent a non-urgent message today (the day after the vaccination) to my doctor describing what happened and what I did. We had discussed precautions prior to the vaccinations because of my allergies.
69 2021-03-13 heart rate increased, blood pressure increased I felt fine after the injection ( approx 10:45 AM) and during the 30 minutes we were asked to wait. ... Read more
I felt fine after the injection ( approx 10:45 AM) and during the 30 minutes we were asked to wait. We drove home, stopping to pick up take-out for lunch, got home and ate. I was calmly sitting/reading when around 1:30 PM I started to feel my heart beating rapidly. Using our home monitor, I checked my BP and HR. (My usual resting values are 130-135/ 75/80 for BP and 80 for HR.) My reading was 160/90 and 101; 5 minutes later it was 175/105 and 106; 5 minutes later it was 185/122 and 116. I started to be quite concerned since it seemed to just keep climbing. I called EMS and they came by to check on me. As they had me take deep breaths, it began to go down. But it took several hours to get back to normal values (@ 8:30 PM it was finally down to 168/79 and 85). I had the same reaction with the second vaccine on 3/4/21, but it did not last as long. It again started about 2 1/2 hours after the shot, but was back to normal by 3:30 PM.
69 2021-03-13 palpitations, chest discomfort, blood pressure increased With in 30 minutes I felt heart palpitations and chest pressure. Causing flushing of face and full... Read more
With in 30 minutes I felt heart palpitations and chest pressure. Causing flushing of face and fullness in my head. Being an ER nurse I went to my hospital and spoke with the charge nurse and got vital signs done. Other than increase BP I was fine. I opted not to be seen. With in less than 30 minutes I was fine. That night about 11 pm I had fever of 101 chills and shaking, aching all over. Lasting most of the night. Next morning I felt better taking Tylenol and Motrin. The next night fever of about 101 chills and shaking. Lasting several hours. Again by morning I was fine, I am A neg blood type.
69 2021-03-14 heart rate increased, pulmonary embolism Symptoms= extreme short of breath and elevated heart rate. Time = 13 days after 1sr dose vaccine sym... Read more
Symptoms= extreme short of breath and elevated heart rate. Time = 13 days after 1sr dose vaccine symptoms started. Went to ER on January 30th. CT scan showed bilateral pulmonary emboli. Doppler showed no sign of DVT. Negative COVID and chest X-ray was clear. ECHO cardiogram showed right heart distress. Treatment= IV Heparin followed by IM Lovenox. ICU X 2days and released to home on Eliquis BID. Follow up with Hematologist and cardiologist.
69 2021-03-14 heart rate increased My heart rate was jumping between 38 - 138 beats per minute for 6 hours.
69 2021-03-14 fainting day 2 (3/2/2021) left arm swelling and red over the inject site; painful to raise arm overhead. day ... Read more
day 2 (3/2/2021) left arm swelling and red over the inject site; painful to raise arm overhead. day 3 - fatigue/chills - arm better, little pink inject area; swelling down. day 4 nausea/regurgitation/loose stools. day 5 called doc Thursday still weak- Dr said symptoms are among those possible; Advised I likely have more severe symptoms for 2nd shot; get gatorade; Imodium, BRAT diet foods, etc. Mon 3/8 had 3 near fainting spells. (3/8 pm -red painful rash on left arm inject site. Lasted till 3/15 Mon COVID ARM?) Checked BP and Pulse/Oxy. Called Doc/video visit; Thought my BP/O2/Pulse numbers OK/ Ordered blood work. 3/11/2021 8:40am did blood/urine tests/ Made follow up appt for 3/16 with GP.
69 2021-03-15 fibrin d dimer increased Severe COVID-19 pneumonia with acute hypoxemic respiratory failure diagnosed 3/12/2021, per hospital... Read more
Severe COVID-19 pneumonia with acute hypoxemic respiratory failure diagnosed 3/12/2021, per hospital discharge summary: On admission patient requiring 10 L nasal pendant to maintain adequate oxygenation. She was admitted to the facility. Chest x-ray showed diffuse interstitial thickening and mild bilateral patchy airspace opacity. Inflammatory markers for notable for CRP of 120, D-dimer 805, ferritin 276. She was treated with dexamethasone (and prophylactic ivermectin) and Lovenox 1 mg/kg twice daily. Remdesivir was deferred given the onset of symptoms > 5 days PTA. She had good response to treatment and over the next 3 days her oxygen was tapered off and she had very good symptomatic improvement. At time of discharge she had minimal symptoms and had an ambulatory O2 sat greater than 94% on room air."
69 2021-03-16 heart rate increased, palpitations Approx. 11 hours after receiving vaccine I developed racing heart, dizziness nausea. Next day still... Read more
Approx. 11 hours after receiving vaccine I developed racing heart, dizziness nausea. Next day still experienced elevated heart rate and also headache. Both of these events lasted for 3 days until Thurs., March 11th.
69 2021-03-16 palpitations Heart palpitations, pain at site of injection, fatigue that evening. Next day tired, tried to eat ... Read more
Heart palpitations, pain at site of injection, fatigue that evening. Next day tired, tried to eat in evening but had to stop, felt like it would come back up,, cold but no fever, diarrhea , and pain at injection site. Wednesday=feel better pain at injection site now minimal, kept down oatmeal and more alert today.
69 2021-03-17 fibrin d dimer increased, blood clot, fast heart rate I had the shot on a Tuesday and developed blood tests by Friday.
69 2021-03-17 heart rate increased, blood pressure decreased - Emergency room visit on 3/16/21 for local reaction to immunization (COVID vaccine). Had redness an... Read more
- Emergency room visit on 3/16/21 for local reaction to immunization (COVID vaccine). Had redness and warmth at injection site on left deltoid. Had similar reaction on 3/4/21 - with initial vaccine, but it went away. Per chart notes in emergency department - "3 cm circular area of erythema with mild warmth at the left middle deltoid area without significant induration or fluctuance. Skin otherwise pink, warm and dry." - Patient reports visual disturbances - seeing shadows at times, fuzzy lights, etc. States her blood pressure dropped - normally runs much higher - and pulse went up. Patient still feeling nauseous today. Had pressure in the back of her head which has nearly resolved.
69 2021-03-17 loss of consciousness Client reports she started to feel "off" just before bed on the day of the vaccination. She felt ti... Read more
Client reports she started to feel "off" just before bed on the day of the vaccination. She felt tired and "not well" all day the day following the vaccination then at 1030pm on the 16th she passed out while sitting at the table. She was unconscious for 1-2 minutes and began vomiting when she came to. Her husband called the ambulance and she was transported to the County Hospital. ER provider told Client that it was a reaction to the vaccination.
69 2021-03-18 blood pressure increased nausea; Blood pressure went up from 105/65 to 155/80; dull aches in achilles tendons; feeling of sti... Read more
nausea; Blood pressure went up from 105/65 to 155/80; dull aches in achilles tendons; feeling of stimulation that kept them from sleeping; diarrhea; headaches; neuropathy; Explosion through their body; really dizzy; weak and wanted to lay on the floor; Fatigue; A spontaneous report was received from a consumer concerning a 69-years-old female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an explosion through their body/feeling abnormal, really dizzy/dizziness, weak, wanted to lay on the floor/asthenia, blood pressure went up from 105/65 to 155/80/blood pressure increased, dull aches in Achilles tendons, headaches, nausea, neuropathy/neuropathy peripheral, feeling of stimulation that kept them from sleeping/tendon discomfort, diarrhea, fatigue. The patient's medical history was not provided. No concomitant medications were reported. No relevant lab data was provided by the reporter. On 25 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot number: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 25 Feb 2021, approximately 5 minutes post vaccination, the patient reported she felt like an explosion went off inside her body. She felt really dizzy, weak and wanted to lay down on the floor which last 2 days. Her blood pressure went from 105/65 to 155/80. Approximately 3 hours later her blood pressure was back in normal range. Later that day, the patient reported she experienced headaches, nausea, neuropathy, dull aches in Achilles tendon, diarrhea and had a feeling of stimulation that kept her from sleeping. On 28 Feb 2021, the patient stated she took zolpidem to help her sleep but it did not work. Treatment details included pseudoephedrine and zolpidem. Action taken with mRNA-1273 in response to the events was unknown. The outcome of event, blood pressure went up from 105/65 to 155/80/blood pressure increased, was considered resolved on 25 Feb 2021 The outcome of event, diarrhea, was considered resolved on 26 Feb 2021. The outcome of events, explosion through their body/feeling abnormal, really dizzy/dizziness, weak, wanted to lay on the floor/asthenia, were considered resolved on 27 Feb 2021. The outcome of events, dull aches in Achilles tendons, headaches, nausea, neuropathy/neuropathy peripheral, feeling of stimulation that kept them from sleeping/tendon discomfort, fatigue, were considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
69 2021-03-18 cerebrovascular accident Major stroke that required surgery and 18 days in the hospital.
69 2021-03-18 chest pain Chest Pain, Shortness of Breath, Dypsnea and epigastric pain. Started approximately 3 am on 3/18/21.... Read more
Chest Pain, Shortness of Breath, Dypsnea and epigastric pain. Started approximately 3 am on 3/18/21. Patient received second dose Moderna on 3/17/21
69 2021-03-18 haemoglobin decreased dehydration vomiting headache resolved after 48 hours
69 2021-03-18 palpitations, chest discomfort Patient presented for second dose - reported feeling dizzy while in the observation area. Upon get... Read more
Patient presented for second dose - reported feeling dizzy while in the observation area. Upon getting home she felt like her throat was closing and her chest was tight, heart pounding, cheeks were flushed and painful. These symptoms lasted 10 minutes. She applied cold compresses to her cheeks. After 10 minutes she began to feel better. She did not seek treatment or call her doctor.
69 2021-03-18 fainting Patient developed headache, nausea, dizziness, and weakness hours after receiving Moderna vaccine (d... Read more
Patient developed headache, nausea, dizziness, and weakness hours after receiving Moderna vaccine (dose number unknown). Seen at Medical Center in the ER; determined to be vasovagal syncope. Location of vaccine administration unknown.
69 2021-03-19 heart rate irregular, palpitations Feb 13-22 racing heart and irregular heart beat for 10 days. Feb 23, 7:30-10:30 am, woke feeling ji... Read more
Feb 13-22 racing heart and irregular heart beat for 10 days. Feb 23, 7:30-10:30 am, woke feeling jittery with steady racing heart and irregular heart beat. Red, slightly raised welt (2.5" x 1.5") appeared at injections site. Called PCP and was advised to go to ER
69 2021-03-20 heart rate increased Chills, low fever, headache about 6 hrs. after second shot. Rapid heartbeat starting about 8 hrs. af... Read more
Chills, low fever, headache about 6 hrs. after second shot. Rapid heartbeat starting about 8 hrs. after second shot. All these symptoms lasted about 16 hours. Also, nausea beginning the morning after the second shot and lasting about 6 hrs. Felt quite fatigued for about 2 days.
69 2021-03-21 hypertension Blood Pressure elevated to 190/110 almost 2 hours after receiving the vaccine; Hives which are heali... Read more
Blood Pressure elevated to 190/110 almost 2 hours after receiving the vaccine; Hives which are healing but still present today and shortness of breath which continues and extreme fatigue.
69 2021-03-21 troponin increased, inflammation of the heart muscle progressive shortness of breath following vaccination starting on day of 2nd shot, resulting in hosp... Read more
progressive shortness of breath following vaccination starting on day of 2nd shot, resulting in hospitalization 3/11, normal CT pulmonary angiogram, elevated troponin, echo with EF 48% and focal hypokinesis, normal coronary angiogram, and Cardiac MRI showing myocarditis
69 2021-03-22 blood pressure increased, heart rate increased Within 5 minutes Iduirng the resting period of 20 minutes I had increased heart rate and blood press... Read more
Within 5 minutes Iduirng the resting period of 20 minutes I had increased heart rate and blood pressure. My Apple watch alerted me to the changes. Later driving home sharp pain in the lymph nodes in the left armpit pain which extended into the area under the left breast implant. At this time ache continues (3/23/21)
69 2021-03-22 oxygen saturation decreased, blood pressure increased 2:50 c/o dizziness, tingling to all extremities. BP 188/103, O2 sat 99%, HR 90, 2:55 BP 190/124 911... Read more
2:50 c/o dizziness, tingling to all extremities. BP 188/103, O2 sat 99%, HR 90, 2:55 BP 190/124 911 called. 3:03 BP 177/100, O2 sat 75 % 3:04 O2 administered at 2L via NC. 3:06 BP 178/103 O2 sat 72% - Epi pen given by RN 3:08 BP 165/101, O2 sat 94% 3:09 EMS arrived 3:15 vitals improving, pt declined ambulance to hospital, AMA 3:30, standing BP 149/85, O2 sat 100% HR 93, transferred to w/c, escorted out by EMS, for pt to call daughter for ride home, AMA.
69 2021-03-22 fainting Patient had the sensation of nearly passing out that resolved with lying supine post injection. Pat... Read more
Patient had the sensation of nearly passing out that resolved with lying supine post injection. Patient monitored and transported to Hopsital via FIre Dept
69 2021-03-23 platelet count decreased, low blood platelet count Diagnosis?s with TTP on March 12. Passes away on March 19 2021
69 2021-03-24 nosebleed, excessive bleeding spontaneous bleed; bruise on the shin; sore arm; hives; nose bleed; A spontaneous report was receive... Read more
spontaneous bleed; bruise on the shin; sore arm; hives; nose bleed; A spontaneous report was received from a consumer, concerning a 69 years-old female patient, who received Moderna's COVID-19 vaccine and experienced sore arm, hives, nose bleed, spontaneous bleed, and bruise on the shin. The patient's medical history included Von Willebrand Disease and breast cancer. Concomitant product use was not provided by the reporter. On 19 JAN 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 012L20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date post-vaccination, the patient experienced a sore arm and some hives. Approximately two weeks after the first dose, the patient experienced a spontaneous bleed resulting in a huge bruise on the shin the size of the palm of their hand. The patient consulted their Hematologist who performed blood work which was perfect. There were no abnormal results. The physician administered DDAVP. On 09 Feb 2021, the patient experienced their first nose bleed described as "horrific". The patient reported they had blood gushing out of their nose and that they bled for four hours. The patient ended up in the hospital emergency department where they were sprayed with DDAVP to stop the bleeding. Treatment details included DDAVP. There was no change planned to the dosing schedule of mRNA-1273 in response to the events. The events, nose bleed and spontaneous bleed were considered not recovered / not resolved. The outcome of the events sore arm, hives, and bruise on the shin was unknown.; Reporter's Comments: Based on the information provided and the patient's history of Von Willebrand Disease, a causal association between the events nose bleed, spontaneous bleed, and bruise on the shin with mRNA-1273 use is assessed as unlikely. However, based on temporal association, causality for the events of sore arm and hives cannot be excluded.
69 2021-03-24 heart attack She was taken to hospital 03/02/2021 where she died at 4 am from a heart attack.
69 2021-03-25 chest pain, heart attack Anterior STEMI with symptom onset (chest pain, n/v) occurring 5 hours post vaccine
69 2021-03-26 anaemia Anemic, fever, nausea, tired, seeing a pulmonologist monday
69 2021-03-27 heart rate increased Feeling of passing out rapid heart rate and feeling drunk for 2 days not able to drive
69 2021-03-28 blood pressure decreased, heart rate increased 1st day: fatigue, chills, glandular soreness. 2nd day: fever of 99, high resting pulse rate of90+... Read more
1st day: fatigue, chills, glandular soreness. 2nd day: fever of 99, high resting pulse rate of90+, significant drop in blood pressure to 93/58, chills and weakness. Vitals returning to near normal as of 03/29/2021
69 2021-03-28 chest pain, chest discomfort Pt was vaccinated at a clinic. Pt reports that while sitting in her observation time on March 1 at ... Read more
Pt was vaccinated at a clinic. Pt reports that while sitting in her observation time on March 1 at clinic, she started to experience physical neck swelling, and chest tightness, but did not report to the monitor at that time. The Pt arrived for her 2nd dose of Moderna on 3/29/21. Pt then reports that she had neck swelling and chest pain for the next 9 days post her 1st dose. Initially the Pt denied having talked with her doctor during that time. I called Dr. to consult with him about if we were able to administer vaccination to this Pt today. Pt denied troubles breathing or swallowing, rash, N/V/diarrhea, but did state she tool her inhaler and Benadryl because of the chest tightness she was experiencing. Per Dr., he states to no give this Pt her 2nd dose of vaccination at this time as she had a mild anaphylactic reaction to the 1st dose of vaccination. Pt was not given 2nd dose and educated to consult with her physician to determine if and where appropriate to receive 2nd dose.
69 2021-03-29 heart rate irregular, palpitations, blood pressure increased, chest discomfort, arrhythmia 1/12 vaccination About 4-5 hours later, I started feeling like I was going to black out; tightness i... Read more
1/12 vaccination About 4-5 hours later, I started feeling like I was going to black out; tightness in my chest. Could see little black dots. I pulled over as I was driving. I got off the interstate and was on the phone with my daughter. She told me to call 911, I put my head down and laid down. The ambulance got there, my daughter was there, and they could feel the skipping of beats. My BP was up, my HR was irregular. I still had the tightness in my chest. The medic said I am going to give you some nitro to see if would help with the tightness. I felt like I was going to black out. Arrhythmia was noticed on the monitor; EMT gave me a jolt of and it immediately stopped the dysrhythmia. Transported to ER, inpatient overnight. Medical team decided I could go home, set up with follow up appt. Put me on a echo, stress test, HR monitor for a month (caught one episode and it lasted 1 hour in the middle of the night). *i feel better but once in a while I get the lightheadedness and can feel the skipping.
69 2021-03-30 chest pain Patient began having symptoms 7 days after vaccination: chest pain, shortness of breath, feeling li... Read more
Patient began having symptoms 7 days after vaccination: chest pain, shortness of breath, feeling like a lump in the throat. Over several days symptoms worsened, and included upper back pain and some pain in the upper left arm. Patient went to urgent care clinic on the morning of March 15, where staff decided to send patient by ambulance to the hospital. She was admitted to the hospital and diagnosed with having 5 blood clots in her lungs. She was discharged March 16 in the evening on Eliquis 5mg twice a day. She states the hospital did not know what caused the blood clots, and were aware she had been vaccinated recently. She has not had a doctor visit in years, but is now established with a primary care physician for follow-up care. The second Moderna dose was given today 3/31/21.
69 2021-03-30 deep vein blood clot bleed on her stomach; blood clot on her leg; A spontaneous report was received from a consumer conc... Read more
bleed on her stomach; blood clot on her leg; A spontaneous report was received from a consumer concerning a 69-year-old female patient who received Moderna (mRNA-1273) vaccine and experienced blood clot on their leg/Deep vein thrombosis and bleed on their stomach/Gastric hemorrhage. The patient's medical history was not provided. No Relevant concomitant medications were reported. On 4 Feb 2021, prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) in the left arm for prophylaxis of COVID-19 infection. On 14 Feb 2021, the patient had a blood clot on their leg for which the patient was hospitalized. While on treatment the patient had a bleed on their stomach. The patient was in ICU for 2 weeks and another week on a regular room. The event, bleed on their stomach, was considered life-threatening. On 4 Mar 2021, the patient was sent to a rehabilitation facility and on 16 Mar 2021, the patient was sent to their home. No Treatment information was provided. Action taken with mRNA-1273 in response to the event(s) was unknown. On an unknown date, the outcome of the events, blood clot on their leg and bleed on their stomach were considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Critical details such as the patient's medical history, list of concomitant medications, diagnostic findings and hospitalization details are lacking. Further information has been requested.
69 2021-03-30 fainting blacked out/ didn't know what was going on; light headed; fever; A spontaneous report was received f... Read more
blacked out/ didn't know what was going on; light headed; fever; A spontaneous report was received from a consumer concerning herself, a 69 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blacked out and didn't know what was going on/syncope, fever/pyrexia, light headed/dizziness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Mar 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch number: 040A21A) intramuscularly for prophylaxis of covid 19 infection. On an unspecified day in Mar 2021, the patient experienced blacked out and didn't know what was going on. She did not lose consciousness. The patient had developed fever and felt light headed. Patient was hospitalized on 13 Mar 2021 due to the events. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, blacked out and didn't know what was going on/syncope, fever/pyrexia, light headed/dizziness were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
69 2021-03-31 loss of consciousness after being well hydrated and adequate food intake, i awoke to go to bathroom at 3:30am and felt fin... Read more
after being well hydrated and adequate food intake, i awoke to go to bathroom at 3:30am and felt fine, after voiding began to feel nauseated and felt as if i would pass out. called for help-when my spouse came in i was on my hands and knees-when he tried to lean be back against the tub, he tells me my head went back and i was ''gone'' i do not recall anything after feeling i would pass out. i awoke flat on my stomach gurgling fluid and my husband was had phone calling 911 was able to let him know i was waking up did not call 911, but i was not able to get up and slept on bathroom floor for 3 hrs-awoke feeling sore and mild weakness resting the day-felt better
69 2021-03-31 palpitations Headaches; Mild dull achy tenderness; Irregular heartbeat; Tingling of their extremities (wrists, ha... Read more
Headaches; Mild dull achy tenderness; Irregular heartbeat; Tingling of their extremities (wrists, hands, feets, chest); Heat on theirhttps://ilssafety1f.quintiles.com/img/tabs/tab_left_move.gif extremities; Inflammation on the extremities; Normal swelling; redness; Pain; A spontaneous report was received from a consumer concerning a female patient of 69-years-old, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events normal swelling, redness, pain, mild dull achy tenderness, tingling of their extremities (wrists, hands, feets, chest)/Paraesthesia, irregular heartbeat/palpitations, heat on their extremities/burning sensation of skin, inflammation on the extremities, headaches. The patient's medical history was not provided. Concomitant medications reported were Depakote for PTSD, acid reflux medicine, blood pressure medication,used for unknown indication. On 26 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 025A21A)vaccine via unknown route for prophylaxis of COVID-19 infection. On 26 Feb 2021,evening of the vaccination day, the patient had normal swelling and redness and pain for 2 and a half days, On 27 Feb 2021,Within the first 24 hrs patient had tingling of the extremities (wrists, hands, feets, chest) along with an irregular heartbeat and it took a day to go away. Had heat and inflammation along with the pain on the extremities. This heat and inflammation lasted longer than the pain. Had the injection on the left side but all of this happened also in their right side. Had headaches too. On 01 Mar 2021, the patient had a mild dull achy tenderness. The patient had it on a Friday afternoon and by Monday morning it was just mild. Before getting the vaccine they tested borderline negative for rheumatoid factor (because their mother has it).the event irregular heart beat was also considered to be medically significant. Treatment details included None. Action taken with mRNA-1273 in response to the events was not reported. The events tingling of their extremities (wrists, hands, feets, chest) and irregular heart beat were considered resolved on 28 Feb 2021. The events normal swelling,redness,pain were considered resolved on 01 Mar 2021. The outcome of the events mild dull achy tenderness, heat on their extremities, inflammation on the extremities and headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
69 2021-03-31 fainting COVID arm and Syncope
69 2021-04-01 chest pain Started with body fatigue so I went to bed. Very restless and couldn't get comfortable because my ar... Read more
Started with body fatigue so I went to bed. Very restless and couldn't get comfortable because my arm hurt.. Sometime during the night I woke up with a crashing headache and I felt as if I couldn't move. At first I thought it to be a dream until I tried to sit up nd everything hurt and my head especially. My chest hurt when I tried to breath deeply. I had chills and couldn't stop shaking although I did eventually. With my body and head aching I was afraid to move because I felt nauseous.The next morning I called a friend, I took naproxen sodium, 200 mg as directed. It is now the following morning and I have a dull headache and slight body aches. The first dose nothing.
69 2021-04-02 chest discomfort As soon as the needle was removed from my arm I experienced flushing, sweating, turned red on chest ... Read more
As soon as the needle was removed from my arm I experienced flushing, sweating, turned red on chest and face and tightness in chest. Waited 20 minutes. I did not direct my concerns to the pharmacist. I went home and slept/rested for 3-4 hours. The initial symptoms were pretty much gone by then. I have had soreness in my left arm and 8 weeks later my arm is still sore around the area where the shot was administered.
69 2021-04-02 palpitations extreme constant heart palpitations in upper chest and neck. they may stop for just a few minutes a... Read more
extreme constant heart palpitations in upper chest and neck. they may stop for just a few minutes and then restart. went for ekg looked abnormal but after stress test dr. said not . he is a cardiologist and did both tests. palpitations will not stop . Im very concerned. feel tired and fatigued and short of breath. No energy.
69 2021-04-03 nosebleed another gushing nose bleed; minor nose bleed; fourth nose bleed; third severe nose bleed; second sev... Read more
another gushing nose bleed; minor nose bleed; fourth nose bleed; third severe nose bleed; second severe nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (second severe nose bleed), EPISTAXIS (third severe nose bleed), EPISTAXIS (fourth nose bleed) and EPISTAXIS (another gushing nose bleed) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer. Concurrent medical conditions included Von Willebrand's disease. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced EPISTAXIS (second severe nose bleed) (seriousness criterion disability). On 25-Feb-2021, the patient experienced EPISTAXIS (third severe nose bleed) (seriousness criterion disability). On 09-Mar-2021, the patient experienced EPISTAXIS (fourth nose bleed) (seriousness criterion disability). On 13-Mar-2021, the patient experienced EPISTAXIS (minor nose bleed). On 18-Mar-2021, the patient experienced EPISTAXIS (another gushing nose bleed) (seriousness criterion disability). On 13-Mar-2021, EPISTAXIS (minor nose bleed) had resolved. In March 2021, EPISTAXIS (fourth nose bleed) had resolved. On 18-Mar-2021, EPISTAXIS (another gushing nose bleed) had resolved. At the time of the report, EPISTAXIS (second severe nose bleed) and EPISTAXIS (third severe nose bleed) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Computerised tomogram head: normal (normal) Normal frontal sinuses, nose, and frontal lobe of brain. Concomitant product use was not reported. Treatment for the nose bleeds included intravenous desmopressin, aminocapriotic acid, cauterization, and packing.; Sender's Comments: This case concerns a 69 Y/O F with multiple serious unexpected events of severe epistaxis. Event onset 8 days after first dose mRNA-1273. Treated with desmopressin, aminocapriotic acid, cauterization. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
69 2021-04-04 chest discomfort, chest pain Chest pain / tightness; nausea; extreme fatigue; pain in left / right rib cages; headache; 48 hours ... Read more
Chest pain / tightness; nausea; extreme fatigue; pain in left / right rib cages; headache; 48 hours to date
69 2021-04-04 nosebleed Bloody nose daily for a week
69 2021-04-04 loss of consciousness Passed out; Dehydrated; kept vomiting; Chills; her arm was swollen, itching and caused pain; arm was... Read more
Passed out; Dehydrated; kept vomiting; Chills; her arm was swollen, itching and caused pain; arm was swollen; caused pain; A spontaneous report was received from a consumer, concerning a 69-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was swollen (peripheral swelling), itching (pruritus), and caused pain (pain in extremity), passed out (loss of consciousness), kept vomiting (vomiting), chills and was dehydrated (dehydration). The patient's medical history was not provided. Concomitant medications reported included ascorbic acid/biotin/dl-alpha tocopheryl acetate, nadolol, acetylsalicylic acid, sertraline, levothyroxine sodium and spironolactone. On 13 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 13 Feb 2021, the patient's arm was swollen, itching and caused pain for about 2 days. On 14 Feb 2021, the passed out. The patient stated that she did not know how long she was out and that the event did not happen again. Since 14 Feb 2021, the patient kept vomiting where she couldn't eat or drink at all and she could eat on 20 Feb 2021. On 14 Feb 2021, the patient had the chills and was dehydrated which lasted for 7 days. The patients' doctor told her not to get the second Moderna COVID-19 vaccination. Treatment information was not provided. The patient was advised by her doctor to avoid getting the second dose of mRNA-1273. The outcome of the events, arm was swollen, itching and caused pain, were considered resolved on 15 Feb 2021. The event, passed out, was considered resolved on 14 Feb 2021. The outcome of the events, kept vomiting and could not eat or drink at all, were considered resolved on 20 Feb 2021. The events, chills and was dehydrated, were considered resolved on 21 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
69 2021-04-04 fainting Fainted 5 times in 1 hour starting 4 hours after receiving vaccine Fainted in bathroom and was injur... Read more
Fainted 5 times in 1 hour starting 4 hours after receiving vaccine Fainted in bathroom and was injured. Called 911. Went to ER. Treated at hospital for 5 days -repeated fainting spells. Released 3/30/21, Remains very weak.
69 2021-04-05 chest discomfort Patients described tightness and heaviness of chest.
69 2021-04-05 loss of consciousness Arm started paining when I went to bed, during the night I felt feverish. After shower I began to f... Read more
Arm started paining when I went to bed, during the night I felt feverish. After shower I began to feel very nauseous and pains at the back of my head. Started to eat cereal after 2nd spoon I felt so nauseous and the pains in the head felt horrible I felt I could not move my head, then I blacked out fell off the dining room chair on the floor fell backwards into my family room (it has one stair), when I came out of it I was lying in the family room my head and shoulders in the family room, my butt was on the stairs, my legs in the kitchen. I spent the entire day in bed using an ice pack all over my body from the head (which was aching real bad), my elbow was bruised from the fall, my lower back was hurting as well as my (L) butt. My temperature was 99.9 so I drank Tylenol Extra Strength twice during the day.
69 2021-04-05 pulmonary embolism Pain in abd and side started on Saturday, patient reported to hospital on 4/6 found on CT scan to ha... Read more
Pain in abd and side started on Saturday, patient reported to hospital on 4/6 found on CT scan to have: Multifocal patchy occlusive and nonocclusive PE involving the bilateral lower lobe and right upper lobe segmental and subsegmental pulmonary arteries. Suggestion of flattening of the interventricular septum raising the possibility of right heart strain. Peripheral airspace opacities in the bilateral lower lobes, left more than right, which could relate to a combination of evolving pulmonary infarcts and/or hypoventilatory changes. Small left pleural effusion.
69 2021-04-06 hypotension Usual reaction, sore arm, chills, headache. Resolved in 48 hours. Then, on 3/10/21, I had terrible... Read more
Usual reaction, sore arm, chills, headache. Resolved in 48 hours. Then, on 3/10/21, I had terrible intestinal cramping, followed by vomiting, blood discharge from rectum. ER on 3/11/21 and hospitalized for 4 days. Diagnosis was Ischemic Colitis caused by low blood pressure. Never had this before and wondering if the low blood pressure and resulting colitis could have been caused by the vaccine
69 2021-04-06 loss of consciousness blacked out/felt going down; feeling weak/could not stand and walk; bumped on floor; dizziness; naus... Read more
blacked out/felt going down; feeling weak/could not stand and walk; bumped on floor; dizziness; nausea; headache; fatigue; chills; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021 at 10:55 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (felt going down), seriousness criterion medically significant), VACCINATION SITE PAIN, CHILLS, DIZZINESS,ASTHENIA (she could not stand) (she could not walk)(feeling weak), FALL(bumped on floor), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). On 29-Mar-2021, LOSS OF CONSCIOUSNESS (blacked out) (felt going down), ASTHENIA(she could not stand),(she could not walk)(feeling weak), FALL (bumped on floor), NAUSEA (nausea), HEADACHE (headache) ,VACCINATION SITE PAIN, CHILLS, DIZZINESSand FATIGUE (fatigue) had resolved. Concomitant medication: very low dose of cholesterol medication. This case was linked to MOD-2021-060481 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
69 2021-04-07 hypertension 6 weeks of daily headache & migraine, exhaustion, weakness, dizzy, nausea, malaise, achey all over, ... Read more
6 weeks of daily headache & migraine, exhaustion, weakness, dizzy, nausea, malaise, achey all over, night sweats and chills. 3rd day high energy and feeling well, 4th day energy reduction ( 5 th day full on symptoms return from 2nd day including unable to think clearly.)
69 2021-04-07 fast heart rate SOB, tachycardia, dizziness, headache - I did not alert a medical professional about my symptoms at ... Read more
SOB, tachycardia, dizziness, headache - I did not alert a medical professional about my symptoms at the time. I watched the clock knowing my wait time was 15 minutes hoping the symptoms would resolve within that time. The SOB and tachycardia resolved in 20 minutes. I had a headache and flu-like symptoms for 24 hrs.
69 2021-04-09 chest pain Chest pains at the pain level of 7. Lasted 2 hours. Okay now.
69 2021-04-09 lightheadedness Patient developed nausea, chills, lightheadedness/near-syncope, decreased appetite, weight loss, hoa... Read more
Patient developed nausea, chills, lightheadedness/near-syncope, decreased appetite, weight loss, hoarse voice, a "nasty taste and smell", and worsened insomnia, anxiety, and fatigue after the 1st Moderna shot. Continues to have symptoms as of 4/5/2021.
69 2021-04-10 blood glucose increased She experienced after 3 hours and lasting up to 2 weeks: Disorientation, dizziness, shortness of bre... Read more
She experienced after 3 hours and lasting up to 2 weeks: Disorientation, dizziness, shortness of breath, elevated blood glucose. Although improved somewhat, she is still experiencing fatigue.
69 2021-04-11 heart attack Minor heart attack 3 days after injection.
69 2021-04-11 blood clot Eight days following the first vaccine I was admitted with massive blood clots to my lets and lungs.... Read more
Eight days following the first vaccine I was admitted with massive blood clots to my lets and lungs. I was hospitalized for 8 days. Four days were in ICU.
69 2021-04-12 hypertension high blood pressure; Arm bothered her; Congested; Right arm started tingling; Not feel well; Eyes ar... Read more
high blood pressure; Arm bothered her; Congested; Right arm started tingling; Not feel well; Eyes are puffy/cannot see out of her eyes; headache/headache got worse; Chills/felt ice cold on one side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (high blood pressure) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes, Kidney disorder and Blood pressure increased (High Blood Pressure). On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion hospitalization), LIMB DISCOMFORT (Arm bothered her), NASAL CONGESTION (Congested), PARAESTHESIA (Right arm started tingling), MALAISE (Not feel well), EYE SWELLING (Eyes are puffy/cannot see out of her eyes), HEADACHE (headache/headache got worse) and CHILLS (Chills/felt ice cold on one side). At the time of the report, HYPERTENSION (high blood pressure), LIMB DISCOMFORT (Arm bothered her), NASAL CONGESTION (Congested), PARAESTHESIA (Right arm started tingling), MALAISE (Not feel well), EYE SWELLING (Eyes are puffy/cannot see out of her eyes), HEADACHE (headache/headache got worse) and CHILLS (Chills/felt ice cold on one side) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood pressure measurement: high (High) it was 175/80 after 10 minutes of receiving the vaccine. and high (High) It was 195/90 after 15 minutes of first measurement.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was hospitalized for 3 days. Treatment given was IV medication to lower blood pressure and Valium.; Sender's Comments: This case concerns a 69-year-old female with a serious unexpected event of hypertension, and nonserious unexpected eye swelling, nasal congestion, paraesthesia, malaise, limb discomfort, and expected headache, chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
69 2021-04-13 atrial fibrillation Onset of sustained atrial fibulation beginning approximately 22 hours post vaccination (second shot... Read more
Onset of sustained atrial fibulation beginning approximately 22 hours post vaccination (second shot) pulse running between 110-145
69 2021-04-13 heart flutter The needle hit a nerve in my arm causing severe pain. After leaving and getting in my card my arm an... Read more
The needle hit a nerve in my arm causing severe pain. After leaving and getting in my card my arm and legs went weak amd left side of face became prickly. Since the.n I?ve had many episodes of weakness and trembling, I also developed ?Covid arm? on day eight after vaccine. Which was redness, swelling, burning pain. Redness went away in 10 days, but the burning pain developed into burning pain from my waist down to my toes, both arms, and my back. Still have prickly sensation in face. The vaccine site has constant pain. Other areas come and go. In general I am weaker , especially my lower torso and legs, but there are times when my whole body goes weak and lasts 1.5 to 2.5 hours at its peak. Spine dr said it is my body reacting to vaccine. Neurologist said the same but he has no explanation for it. At times my upper left arm is so painful I cannot stand it. Then if I have a weakness spell, the burning subsides and only the injection site hurts. Some nights I cannot get to sleep because of the burning pain in my legs . I also get heart fluttering during the weakness episodes
69 2021-04-13 nosebleed Frequent nose bleeds beginning the day after the vaccination.
69 2021-04-14 heart rate increased Burning throughout body, redness, rapid heart rate.
69 2021-04-14 pulmonary embolism, deep vein blood clot I developed a pulmonary embolus after my second Moderna covid-19 shot. My PSO2 dropped to 86% and Do... Read more
I developed a pulmonary embolus after my second Moderna covid-19 shot. My PSO2 dropped to 86% and Doppler found that i had an extensive DVT in my right leg, of which I was unaware. I have had no cardiovascular issues prior to this - I'm average weight, don't smoke and had no know risk factors at the time. I'm undergoing extensive testing now to see if there was a reason for my DVT and PE>
69 2021-04-14 pulmonary embolism 1. Bilateral acute pulmonary emboli noted. No evidence of right ventricular strain. 2. Prominence ... Read more
1. Bilateral acute pulmonary emboli noted. No evidence of right ventricular strain. 2. Prominence of the pulmonary interstitium and ground-glass density throughout both lungs. This is suggestive of bilateral pulmonary edema. Bilateral pneumonia can give a similar appearance. 3. Small bilateral pleural effusions, right larger than left.
69 2021-04-15 palpitations, blood pressure increased Immediately began to tingle in both arms,legs. Blood pressure over 200, heart rate 115. Extremely... Read more
Immediately began to tingle in both arms,legs. Blood pressure over 200, heart rate 115. Extremely weak. In a fog. Heart racing. Got the chills and very shakey. Doctor(s) and nurses monitored my vitals, then transferred me to ER for monitoring. Blood pressure down to 170, heart rate normal range. Tingling and weakness still happening. A little after an hour of this happening and my pressure still at 170, they allowed me to go home. I rested. The next 24-48 hours, I had a headache and felt nauseous, not votmitting. Tylenol helped. By 3rd day, felt fine.
69 2021-04-15 transient ischaemic attack mini stroke
69 2021-04-16 loss of consciousness Passed out
69 2021-04-16 oxygen saturation decreased Started with odd pain in back shoulder bladearea on March 19, 2021,Got diarrhea with bloating 03/20/... Read more
Started with odd pain in back shoulder bladearea on March 19, 2021,Got diarrhea with bloating 03/20/21 with I thiught was cause of shortness of breath. Shortness of breath got worse till I took some prednosone I had, on April 4, 2021 thinking I was having an asthma attack. Helped a few days. Shortness of breath returned on April 9, 2021. On April 10 we went to critical care thinking I was having asthma attack as extremely short of breath! They said it wasnt asthma but sent me to ER as my oxygen levels were low. In ER they took many tests including CAT scan and ultrasound, which resulted in diagnosis of several large bloodclots in both lungs
69 2021-04-18 chest discomfort Patient reported right chest was feeling "funny" and hand achy/tingling. She also stated that she ha... Read more
Patient reported right chest was feeling "funny" and hand achy/tingling. She also stated that she had mental fogginess after her first dose and felt it was happening with this dose as well. Vitals were monitored and stable for the time she was here ~45 minutes. At time of dismissal she was feeling better and her husband was here to transport her.
69 2021-04-18 heart rate increased Cramps, projectile vomiting. nausea , rapid heart beat , low grade fever, Horrible cramping , loose ... Read more
Cramps, projectile vomiting. nausea , rapid heart beat , low grade fever, Horrible cramping , loose stools , rednes of face ears and neck , all cleared up in a day and a half except cramping , which lasted 2 more days
69 2021-04-18 hypertension, cerebrovascular accident, stroke Jan 11, 2021?.First Mederna COVID-19 Vaccine Jan 21, 2021?.Had episode of head feeling like it was w... Read more
Jan 11, 2021?.First Mederna COVID-19 Vaccine Jan 21, 2021?.Had episode of head feeling like it was whirling around. BP was extremely high. ER was running over with COVID patients and no rooms. I took her to see. Not having classic signs of stoke and EKG was done it was fine. Caroitid us and ECHO was ordered. All were NEG. Referred to Dr. for a Heart Cath. Feb 25, 2021 Heart Cath was NEG. Followed up with Dr. and he ordered a Ct Scan of her head with and without contrast. He Also wanted her to see Dr. or Dr. to have her eyes fully examined. Dr. couldn't find anything wrong with her eyes. He said they looked healthy. Mar 12, 2021?.CT of head was done this was a Friday. Mar 15,2021?. Dr called me at work and told me Mama had had a stroke. A Rt Frontal Lobe Infarction She continued having these episodes throughout the weekend with her eyes not being able to focus and feeling. like her eyes where getting hung in their socket. Mar 16, 2021 Seen Dr and he ordered a MRI to see what It would show. Mar 18, 2021 MRI done and the results were NEG? (That?s complete BULLCRAP if you ask me)! April 14, 2nd reading was requested by FNP 2nd IMPRESSION read by Dr. although there are no acute intracranial abnormalities detected, there is a small area of encephalomalacia in the right lentiform nucleus extending to the right caudate head with ex vacuole dilation of the anterior horn of the right lateral ventricle. Ekg- Jan 21,2021 Echo- a week after the EKG Carotid Ultrasound- same as ECHO Heart Cath- Feb. 25, 2021 Cardiologist- Dr. - had to follow up with him due to having a heart cath and BP continuing to spike at random times Optometrist Dr. - twice to rule out anything going wrong with eyes- NEG both visits Now we are waiting to follow up with Dr Neurologist
69 2021-04-19 hypertension, body temperature decreased LOW TEMPERATURE 96.5 - 95.6 TO 95.9 FOR 5DAYS AND THEN FROM 95.8 TO 97.00. OXYGEN WAS 93-95. FEEL... Read more
LOW TEMPERATURE 96.5 - 95.6 TO 95.9 FOR 5DAYS AND THEN FROM 95.8 TO 97.00. OXYGEN WAS 93-95. FEEL WEAKNESS , HIGH BLOOD PRESURE
69 2021-04-20 heart rate increased, hypertension started feeling belly muscle twitches in her belly area it hurts and disturbing; left side of her he... Read more
started feeling belly muscle twitches in her belly area it hurts and disturbing; left side of her head she had twitches near to ear; at the same time she felt trembling in her bod; she can still feel nerve on her right side of her face near to eye; not feeling well; face wash flushed; heart rate was up; feeling loose; blood pressure, it was up than the normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (not feeling well), ERYTHEMA (face wash flushed), HEART RATE INCREASED (heart rate was up), FEELING ABNORMAL (feeling loose), HYPERTENSION (blood pressure, it was up than the normal), MUSCLE TWITCHING (started feeling belly muscle twitches in her belly area it hurts and disturbing), MUSCLE TWITCHING (left side of her head she had twitches near to ear), TREMOR (at the same time she felt trembling in her bod) and NEURALGIA (she can still feel nerve on her right side of her face near to eye) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included METHIMAZOLE for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced MALAISE (not feeling well) (seriousness criterion hospitalization), ERYTHEMA (face wash flushed) (seriousness criterion hospitalization), HEART RATE INCREASED (heart rate was up) (seriousness criterion hospitalization), FEELING ABNORMAL (feeling loose) (seriousness criterion hospitalization) and HYPERTENSION (blood pressure, it was up than the normal) (seriousness criterion hospitalization). On 16-Mar-2021, the patient experienced MUSCLE TWITCHING (started feeling belly muscle twitches in her belly area it hurts and disturbing) (seriousness criterion hospitalization), MUSCLE TWITCHING (left side of her head she had twitches near to ear) (seriousness criterion hospitalization), TREMOR (at the same time she felt trembling in her bod) (seriousness criterion hospitalization) and NEURALGIA (she can still feel nerve on her right side of her face near to eye) (seriousness criterion hospitalization). At the time of the report, MALAISE (not feeling well), ERYTHEMA (face wash flushed), HEART RATE INCREASED (heart rate was up), FEELING ABNORMAL (feeling loose), HYPERTENSION (blood pressure, it was up than the normal), MUSCLE TWITCHING (started feeling belly muscle twitches in her belly area it hurts and disturbing), MUSCLE TWITCHING (left side of her head she had twitches near to ear), TREMOR (at the same time she felt trembling in her bod) and NEURALGIA (she can still feel nerve on her right side of her face near to eye) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication consisted of thyroid medication and graves disease medication. This case concerns a 69-year-old female hospitalized with serious unexpected events of malaise, feeling abnormal, hypertension, heart rate increased, feeling abnormal, neuralgia, muscle twitching, tremor, and erythema. Event onset "within 10 minutes" after the first dose of mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: This case concerns a 69-year-old female hospitalized with serious unexpected events of malaise, feeling abnormal, hypertension, heart rate increased, feeling abnormal, neuralgia, muscle twitching, tremor, and erythema. Event onset "within 10 minutes" after the first dose of mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
69 2021-04-20 hypertension really really sick - with chemotherapy; blood pressure was slightly elevated; felt unusual; Temperat... Read more
really really sick - with chemotherapy; blood pressure was slightly elevated; felt unusual; Temperature was 100.4F.; exhausted; pressure in the area of her cancer (left lung cancer)/felt was like somebody was squeezing her lungs/tightened up in the area of her cancer; painful in the area of her cancer; difficulty in breathing; lot of discomfort; Second dose administered on 38th day; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT IRRITATION (pressure in the area of her cancer (left lung cancer)/felt was like somebody was squeezing her lungs/tightened up in the area of her cancer), PULMONARY PAIN (painful in the area of her cancer) and DYSPNOEA (difficulty in breathing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No recorded medical history). On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered on 38th day). On 23-Mar-2021, the patient experienced RESPIRATORY TRACT IRRITATION (pressure in the area of her cancer (left lung cancer)/felt was like somebody was squeezing her lungs/tightened up in the area of her cancer) (seriousness criterion intervention required), PULMONARY PAIN (painful in the area of her cancer) (seriousness criterion intervention required), DYSPNOEA (difficulty in breathing) (seriousness criterion intervention required) and DISCOMFORT (lot of discomfort). On 27-Mar-2021, the patient experienced ILLNESS (really really sick - with chemotherapy), HYPERTENSION (blood pressure was slightly elevated), MALAISE (felt unusual), PYREXIA (Temperature was 100.4F.) and FATIGUE (exhausted). On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered on 38th day) had resolved. On 26-Mar-2021, RESPIRATORY TRACT IRRITATION (pressure in the area of her cancer (left lung cancer)/felt was like somebody was squeezing her lungs/tightened up in the area of her cancer), PULMONARY PAIN (painful in the area of her cancer), DYSPNOEA (difficulty in breathing) and DISCOMFORT (lot of discomfort) had resolved. On 31-Mar-2021, ILLNESS (really really sick - with chemotherapy), HYPERTENSION (blood pressure was slightly elevated), MALAISE (felt unusual), PYREXIA (Temperature was 100.4F.) and FATIGUE (exhausted) had resolved. Not Provided Concomitant product use was not provided by the reporter. Because of chemotherapy the patient rescheduled her second shot and so it was delayed. Four days after the second shot she got pressure in the area of her cancer (left lung cancer), it tightened up, she had difficulty in breathing, painful, lot of discomfort, it was like somebody was squeezing her lungs. Few days later (2-3 days) she got really really sick and felt very tired - she was under chemotherapy. This never happened before with the chemotherapy (she has been taking it from several years). Her blood pressure was slightly elevated. Temperature was 100.4F. She felt very unusual and exhausted. All this happened for about for about 4-5 days. Treatment for the event included acetylsalicylic acid. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded. However, noting the subject's currently chemotherapy may remain as confounder. This report refers to a case of (inappropriate schedule of product administration) for mRNA-1273, lot # 013M20A, with no associated AEs. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded. However, noting the subject's currently chemotherapy may remain as confounder. This report refers to a case of (inappropriate schedule of product administration) for mRNA-1273, lot # 013M20A, with no associated AEs. Further information has been requested.
69 2021-04-20 hypotension, fainting Patient was noted to have a low blood pressure between 80 and 90 systolic during and after the seizu... Read more
Patient was noted to have a low blood pressure between 80 and 90 systolic during and after the seizure. Did have an syncopal episode later on during course of treatment but was treated with 500 mL of NaCl and oral crackers w/ peanut butter.
69 2021-04-21 blood pressure increased Elevated blood pressure discovered during routine office visit on April 6, approx. one week after se... Read more
Elevated blood pressure discovered during routine office visit on April 6, approx. one week after second vaccine dosage.
69 2021-04-21 chest discomfort allergic reaction to the vaccine; Chills; Shortness of Breath; Light Headedness; Numbness of the che... Read more
allergic reaction to the vaccine; Chills; Shortness of Breath; Light Headedness; Numbness of the cheek; Pressure on the chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of Breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical reported history). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath) (seriousness criterion medically significant), DIZZINESS (Light Headedness), HYPOAESTHESIA (Numbness of the cheek) and CHEST DISCOMFORT (Pressure on the chest). On 04-Apr-2021, the patient experienced VACCINATION COMPLICATION (allergic reaction to the vaccine) and CHILLS (Chills). On 26-Mar-2021, DIZZINESS (Light Headedness) had resolved. At the time of the report, DYSPNOEA (Shortness of Breath), HYPOAESTHESIA (Numbness of the cheek), CHEST DISCOMFORT (Pressure on the chest), VACCINATION COMPLICATION (allergic reaction to the vaccine) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case concerns a 69-year-old female with a serious unexpected event of dyspnea, chest discomfort, dizziness, hypoesthesia, vaccination complication and expected chills. Event onset the same day as mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 69-year-old female with a serious unexpected event of dyspnea, chest discomfort, dizziness, hypoesthesia, vaccination complication and expected chills. Event onset the same day as mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
69 2021-04-21 hypertension, pulmonary embolism, deep vein blood clot Patient presented for the outpatient procedure of a cataract extraction. Found to be hypertensive a... Read more
Patient presented for the outpatient procedure of a cataract extraction. Found to be hypertensive and very short of breath. Sent to primary care physicians office who in turn ordered a CT scan. Found to have Pulmonary Embolism and Deep Vein Thrombosis
69 2021-04-23 heart rate increased, pallor After about a half an hour after the shot (on the way home), I noticed my left arm was tingling from... Read more
After about a half an hour after the shot (on the way home), I noticed my left arm was tingling from the elbow down. By day 2 both my arms and legs in their entirety and the lower right side of my face were tingling. My ears were ringing more than usual. My heart seemed to be beating a little fast. My husband said I looked pale. I called my PCP. His nurses relayed that this should go away in 2-3 days, It didn't. It got much worse. By day 3, my entire arms and legs had gone numb. I have weird burning sensations in my insides and arms and legs that come and go. Now after 5+ weeks I am beginning to get occasional cramps in my legs. At times, my hands and feet are very cold. I feel pain in my hands, feet, etc. It doesn't feel like it's getting any better. It feels like it's getting worse. It's worse at night with increased tingling and it's hard to get to sleep. I've had ongoing discussions about these reactions with various pharmacists both via e-mail and by phone. I don't know if this is ever going away. I didn't mark permanent damage below because I don't know yet.
69 2021-04-24 palpitations day after the second vaccination I was sick in bed all day with fever, chills, muscle painand fatigu... Read more
day after the second vaccination I was sick in bed all day with fever, chills, muscle painand fatigue. For next week,I was very tired and had to push myself to get anything done. Then I started feeling my heart pounding which lasted for about for about 10 days 24/7. I saw a new Dr on March 30th, and she sent me for lab work and an Echo. All tests so far are negative. The pounding is no longer 24/7, but the episodes which feel like adrenaline rushes come daily anywhere from 2-12 hours leaving me exhausted. I am currently wearing a heart rate monitor and will have a stress echo in May to rule out heart disease. Also looking into tests to see if the problem comes from the adrenaline glands. I was in top shape and feeling wonderful before the 2nd shot.
69 2021-04-25 stroke, bleeding on surface of brain On 4/3 patient developed neck pain and headache. She had reportedly received her second dose of Mod... Read more
On 4/3 patient developed neck pain and headache. She had reportedly received her second dose of Moderna COVID vaccine within 1 week prior, but exact date unknown. She became acutely confused and reported tingling in her left fingers on 4/9 prompting presentation to Medical Center. MRI was performed 4/10 reportedly showing an acute focal right corona radiata lacunar infarct. On 4/11 patient became more agitated and 4/12 developed worsening headache and global aphasia. Non-contrast head CT showed multiple areas of subarachnoid hemorrhage bilaterally. MRI brain felt to also have small areas of bilateral diffusion restriction throughout right more than left cerebral hemispheres with concern for leptomeningeal involvement. She was transferred to another facility for higher level of care on 4/14. LP on 4/16 with TNC 33 (95% lymphs, 3% monos, 2% macrophages), RBC 1425, Protein 521, glucose 68. CSF gram stain/culture negative fungal culture and cryptococcal antigen negative, VZV PCR negative, HSV PCR negative, PCR meningitis/encephalitis panel negative, enterovirus culture negative. Serum VZV IgG positive but PCR negative, Lyme and treponemal antibodies negative, HIV Ab negative, ANA/ANCA/Sjogren's antibodies negative. Repeat LP 4/21 with TNC 43 (52% PMN, 35% lymphs, 11% monos, 1% baso, 1% myelos), protein 745, glucose 76). However, given high suspicion for viral encephalitis patient was recommended to complete a 10-14 day course of IV acyclovir by inpatient ID consult service (start date 4/16). She was also treated with empiric steroids. The neurology team is concerned for a possible vasculitis vs reversible cerebral vasoconstriction syndrome as potential etiologies. Brain biopsy performed 4/23 to help clarify diagnosis, results pending.
69 2021-04-25 chest pain C/O CHEST PAIN, SOB, DIZZINESS, SELF-ADMINISTERED ALBUTEROL INHALER. REPORTED HAVING SIMILAR SYMPTOM... Read more
C/O CHEST PAIN, SOB, DIZZINESS, SELF-ADMINISTERED ALBUTEROL INHALER. REPORTED HAVING SIMILAR SYMPTOMS WITH FIRST DOSE OF MODERNA. PARAMEDIC CAME, WAS GIVEN WATER, NITRO SPRAY, WAS TRANSPORTED TO HOSPITAL
69 2021-04-26 chest pain, chest discomfort, palpitations Main symptoms are heart palpitations mostly occuring in early morning hours 2 am to 5 am, shortness ... Read more
Main symptoms are heart palpitations mostly occuring in early morning hours 2 am to 5 am, shortness of breath, swollen upper abdomen, pressure in chest, pain on left chest, neck and left arm, tiredness, and insomnia.
69 2021-04-26 nosebleed Day 1. Evening, sore upper left arm. Day 2. Cold and achy all day; not chills, but rather cold fr... Read more
Day 1. Evening, sore upper left arm. Day 2. Cold and achy all day; not chills, but rather cold from the core on out. Stayed in bed bundled up with lots of covers, no sleep all day. Got up every two hours to pee and eat something. In a.m. could only navigate going downstairs by one step at a time with both feet and holding securely to rails on both sides, as I did not trust my knee, hip, ankle and feet joints and muscles. By end of day could navigate stairs normally. Fatigue, foggy mentally, and bicep pain and limited range of motion all day. Night 2. Woke at 3 a.m. with extreme headache; got up and went pee and drank a half cup of apple juice; headache gone in twenty minutes and went back to sleep. Day 3. Thigh and calf muscles of both legs, but mostly left thigh, spasm-ed with pain, off and on all day. Body temp back to normal. General achiness, fatigue, lack of mental clarity, and pain itchiness redness of left bicep and limited range of motion continued. Day 4. Nose bleed lasting about five minutes, mid-morning. Achiness and fatigue not as severe; clarity returning. Days 5 through 7. Gradual improvement of all symptoms. Days 8 through 14. Final resolution of all symptoms; able to confidently take dog for regular walk, and to do errands and important financial coversations.
69 2021-04-26 loss of consciousness, haemoglobin decreased, fainting Pt states that one day after COVID vaccine dose 2 - had HA, became dizzy, diaphoretic, and had synco... Read more
Pt states that one day after COVID vaccine dose 2 - had HA, became dizzy, diaphoretic, and had syncopal episode. Pt states she was only unconscious for a second. Pt states that her appetite was poor that day and she did not eat leading up to this syncopal episode. Denies hitting head. Pt states she ate a large meal and felt better. Denies any subsequent dizziness, CP, or SOB.
69 2021-04-26 palpitations, atrial fibrillation I had a marked increase in number and severity of heart palpitations starting 1 week after my first ... Read more
I had a marked increase in number and severity of heart palpitations starting 1 week after my first dose (above info) and continuing for 2 1/2 weeks after my second Moderna shot on 2/18/2021. In other words an increase in my symptoms of AFib.
69 2021-04-27 blood pressure increased 1. Got 1st shot Modena on left arm on January 17, 2021, usual headache sore muscle and tired for a d... Read more
1. Got 1st shot Modena on left arm on January 17, 2021, usual headache sore muscle and tired for a day. 2. Blood pressure shot up to 159 accidentally when visit dental office on January 27, 2021 3. Got 2nd shot Modena on left arm on February 16, 2021, usual sore muscle, better than after 1st shot. 4. Blood pressure continue to shot up to 169 when visit up night guard on Feb 24, 2021 5. Visit primary Dr, blood pressure continued to be as high as 159. 6. On April 23, 2021, while visit dental office, blood pressure shot up to 179/75 causing personnel alarm and advise to talk to PCP. 7. Checking Blood pressure daily at home using portable wrist cuff: upper number measurement ranged from 140 to 197 in the last week as I checked daily, morning, noon and evening.
69 2021-04-28 palpitations Two days after the first dose of Moderna, I experienced severe shortness of breath which lasted the ... Read more
Two days after the first dose of Moderna, I experienced severe shortness of breath which lasted the entire month of February. After walking up a flight of stairs, I had to lay down on the floor to catch my breath. My heart was pounding. I was unable to walk my normal 3 miles a day because it produced the same symptoms. I went to my doctor and but it could not be determined if the vaccine caused it. Interestingly, two days after receiving my second shot (March 10, 2021), the shortness of breath went away as mysteriously as it came. I can go up and down the stairs without breathing difficulty and have resumed daily walks without any problems.
69 2021-04-28 fainting Headache, joint pain, and 15 hours after injection hot flashes sweating and nausea. Fainted 2 times ... Read more
Headache, joint pain, and 15 hours after injection hot flashes sweating and nausea. Fainted 2 times within a few minutes. 10 minutes later it all passed and felt okay.
69 2021-04-29 pulmonary embolism, chest discomfort, heart rate increased Patient received 1st dose of moderna vaccine on 3/31/21. Patient went to the ED on 4/18/21 complaini... Read more
Patient received 1st dose of moderna vaccine on 3/31/21. Patient went to the ED on 4/18/21 complaining of 2 weeks of worsening shortness of breath, fatigue, weakness, and new onset chest heaviness which ultimately was a pulmonary embolism (PE). Patient did not have any prior health/risk factors to PE. Patient did test positive for COVID-19 on 4/18
69 2021-04-30 excessive bleeding She did not get much sleep one night; Bleeding profusely; Horrible cramping; Blood red, vampire red ... Read more
She did not get much sleep one night; Bleeding profusely; Horrible cramping; Blood red, vampire red eye; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding profusely) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LOSARTAN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced HAEMORRHAGE (Bleeding profusely) (seriousness criterion medically significant), MUSCLE SPASMS (Horrible cramping) and OCULAR HYPERAEMIA (Blood red, vampire red eye). On an unknown date, the patient experienced SLEEP DISORDER (She did not get much sleep one night). At the time of the report, HAEMORRHAGE (Bleeding profusely), MUSCLE SPASMS (Horrible cramping) and SLEEP DISORDER (She did not get much sleep one night) outcome was unknown and OCULAR HYPERAEMIA (Blood red, vampire red eye) had not resolved. She is on HRT implant called BioTe and is scheduled for a Pap Smear After the first dose apart from fever she got all the flu like symptoms which lasted 6 days. 2 weeks after the second dose, she got horrible cramping and bled profusely for 7 days. She adds that her husband snores and she did not get much sleep one night and woke up the next day with some redness in her left eye which turned blood red, vampire red in the next few days. The eye is still red so she went to her retinologist to get her eye checked and he said there is no issue with the eye. She is concerned about her upcoming cataract surgery on Monday. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
69 2021-05-01 pulmonary embolism Patient returned for 2nd dose on 3/26/2021, at that time, she reported to nurse that she was hospita... Read more
Patient returned for 2nd dose on 3/26/2021, at that time, she reported to nurse that she was hospitalized at a Medical Center around 9-10 days after first dose of vaccine due to a pulmonary embolism. Attempts made to the hospital to obtain records but did not receive any.
69 2021-05-04 cerebrovascular accident, stroke Stroke. Foci of acute/subacute infarction in the right putamen/corona radiata, right insular cortex,... Read more
Stroke. Foci of acute/subacute infarction in the right putamen/corona radiata, right insular cortex, right superior frontal gyrus, and left occipital periventricular white matter. No evidence of hemorrhagic transformation or petechial microhemorrhage. No associated mass effect, midline shift, or herniation. Generalized cerebral volume loss on a background of chronic microvascular ischemic changes.
69 2021-05-05 nosebleed Patient reported having a nosebleed for 3 days.
69 2021-05-06 chest pain, chest discomfort 02/27/2021 -received vaccine #1. 03/01/2021 - began to have chest tightness. All through March I fel... Read more
02/27/2021 -received vaccine #1. 03/01/2021 - began to have chest tightness. All through March I felt bad with symptoms of muscle aches, headaches, shortness of breath, loss of appetite, nausea. By the middle of March I felt so bad that on the 17th I had a covid test, which turned out negative. On the 20th I had nausea and vomiting and a fever of 101 to 102 degrees. I received instructions to use ondansetron for the Nausea/vomiting and Tylenol for the fever. On the 22nd I had a virtual with the nurse practitioner; she determined I had a GI virus and was not in need of anything further. I felt better on the 25th & 26th and decided to get vaccine #2 on the 03/27/2021. On the night of the 27th I went to the ER for worsening shortness of breath and chest pain, especially with deep inspiration, and nausea/vomiting. I was admitted to medical center with a (later) diagnosis of Bilateral Pleural Effusion. I was started on antibiotics and received multiple tests including x-rays, blood tests, cardiac function,Ct scan with contrast, images from nuclear med and more. A thoracentesis was done to drain a pocket of fluid in the left lower pleura - 700cc was removed and sent to the lab. Between the blood work and the pleura fluid it was determined that I had Systemic Lupus. I had no other acute s/s of Lupus although the Cutaneous Lupus had been diagnosed for many years.
69 2021-05-07 chest discomfort Severe headache, tightness in chest, mild vertigo, mild vision disturbance
69 2021-05-09 fluid around the heart, low blood oxigenation minimal pericardial effusion; my oxygen saturation again plummeted/getting difficult to maintain my ... Read more
minimal pericardial effusion; my oxygen saturation again plummeted/getting difficult to maintain my oxygen level during the day; mild arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOXIA (my oxygen saturation again plummeted/getting difficult to maintain my oxygen level during the day) and PERICARDIAL EFFUSION (minimal pericardial effusion) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 03IL20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypoxia. Concurrent medical conditions included Pulmonary hypertension (Reporter states: Pulmonologists disagree about this diagnosis) since May 2019 and Sleep apnea since March 2019. Concomitant products included LORATADINE for Allergy, VITAMIN D3 and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for Deficiency vitamin. On 05-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (mild arm pain). On 07-Mar-2021, the patient experienced HYPOXIA (my oxygen saturation again plummeted/getting difficult to maintain my oxygen level during the day) (seriousness criterion medically significant). On an unknown date, the patient experienced PERICARDIAL EFFUSION (minimal pericardial effusion) (seriousness criterion medically significant). At the time of the report, HYPOXIA (my oxygen saturation again plummeted/getting difficult to maintain my oxygen level during the day) and PERICARDIAL EFFUSION (minimal pericardial effusion) had not resolved and PAIN IN EXTREMITY (mild arm pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Oxygen saturation: low (Low) Low. On 17-Apr-2021, Brain natriuretic peptide: 1064 (High) "nearly 10 times the normal limit and is a strong indicator of heart failure". On 29-Apr-2021, Computerised tomogram thorax: abnormal (abnormal) minimal pericardial effusion. Reporter states: I was diagnosed two years ago with sleep apnea and nocturnal hypoxia and have used a CPAP device with oxygen every night since. Following the first dose of the vaccine, my oxygen level was so low that I had to go onto daytime supplemental oxygen for the first time. After the second dose of the vaccine, my oxygen saturation again plummeted. I have been on 3-4 L of daytime supplemental oxygen ever since. It is getting difficult to maintain my oxygen level during the day even with supplemental oxygen. The cardiologist has ordered an echocardiogram for May 7, 2021. That should help determine if my breathing difficulties are due to a sudden worsening of pulmonary hypertension, or if this could be related to the vaccines. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-029767 (E2B Linked Report). This case was linked to MOD-2021-029686, MOD-2021-029686 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD-2021-029767:Reporter's friend's case
69 2021-05-10 chest pain The decedent experience nausea, headache, and chest pain approximately 72 hours after receieving her... Read more
The decedent experience nausea, headache, and chest pain approximately 72 hours after receieving her second shot. She was found deceased later that day.
69 2021-05-11 chest discomfort 10 hours after receiving the second vaccine, nausea, all over body ache, chills lasted 3 days, about... Read more
10 hours after receiving the second vaccine, nausea, all over body ache, chills lasted 3 days, about week later right arm was so sensitive and ached from wrist to side of neck for 2 months, couldn't life anything. 3 weeks after vaccine client developed a "severe chest cold symptoms" felt like everything was in her lower lungs and she coughed until her muscles were excruciating sore and separate a rib on the left back area. Still having issues and following up with PMD having labs, xrays to assess concerning continuous symptoms, and is nauseated daily without vomiting. Client is very weak. heaviness in chest and throat still.
69 2021-05-11 loss of consciousness At about 6:45AM on March 2, I fell unconscious to the floor while cooking oatmeal on the stove. I wo... Read more
At about 6:45AM on March 2, I fell unconscious to the floor while cooking oatmeal on the stove. I woke up with burns from the oatmeal on my left hand and arm, right hand and left thigh.( I felt light headed just before losing consciousness. ) I was examined by a doctor at the local burn center and was told I had 2nd and 3rd degree burns. I was admitted to the hospital and had surgery on the 4th of March to excise the burns and application of a skin substitute. On March 18 i had surgery for a skin graft to all burn sites. Tests had been performed to make sure there was not a problem with my heart and all tests were normal
69 2021-05-12 heart rate increased, blood pressure increased Twenty hours after second vaccine shot my pulse rate increased 50% increase. Even while sleeping al... Read more
Twenty hours after second vaccine shot my pulse rate increased 50% increase. Even while sleeping almost completely the next 36 hours my pulse remained very elevated. Also my blood pressure has been elevated by 15 to 25 points ever since the vaccine. Which has now been four weeks.
69 2021-05-12 pulmonary embolism, fainting Unknown date of vaccination, physician asked for this to be reported, possibly related to Covid vacc... Read more
Unknown date of vaccination, physician asked for this to be reported, possibly related to Covid vaccine. Patient admitted to hospital with syncope and bilateral pulmonary embolism. Patient treated and discharged home after after 2 days
69 2021-05-12 blood clot Late in the evening on May 12, my mother started having pain on her right side. She also could not ... Read more
Late in the evening on May 12, my mother started having pain on her right side. She also could not take a deep breath without having a stabbing-like pain. The pain level was severe and kept her awake all night. On May 13, she went to the urgent care department at the medical center. An xray of her chest cavity was taken. It showed fluid in her right lung, but the results were inconclusive because of her limited able to take a deep breath. Extensive blood work was also performed. The urgent care doctor suspected that she has a blood clot in her lung, and she was sent to the hospital for further testing. She is still in the ER of the Medical Center. They are still doing tests and have not officially confirmed that she has a blood clot yet.
69 2021-05-12 blood clot A large blood clot developed in my right leg. From the top of the thigh/groin area to my ankle. We... Read more
A large blood clot developed in my right leg. From the top of the thigh/groin area to my ankle. Went to the emergency room. I was admitted and over 3days, approximately 7 hours the clot was busted with stents and balloons put in. My hospital stay was from April 19, 2021 to April 24, 2021. I didn?t realize what was happening as my leg just keep swelling. I have never had a clotting problem. I have had major surgery (gall bladder removal), a left hip and knee replacement and bunions removed from both feet. Never have had a blood clot problem.
69 2021-05-13 deep vein blood clot DVT blood clot in back of left calf. Swelling at foot and ankle
69 2021-05-15 deep vein blood clot, pulmonary embolism 2/12/21 2nd round; 2/13/21: Woke up with chills, then sweats, fever of 102 fluctuated, aches and pa... Read more
2/12/21 2nd round; 2/13/21: Woke up with chills, then sweats, fever of 102 fluctuated, aches and pains, stayed in bed for 4 days. It took a week to become active again. Called my doctor's office several times. I was told it was normal, part of the vaccine reaction. Worse reaction was my leg bones feeling like metal strips of a toy erector set. The taste of metal in my mouth lasted 4 days. Difficulty walking because of leg weakness and dizziness. Loss of appetite. 5/1/21 - 5/3/21 Hospitalization for diagnosis of Acute Pulmonary Embolism and Deep Vein Thrombosis
69 2021-05-15 heart rate increased Vaccine 2nd dose on Friday May 7th, 2021, Saturday may 8,2021 had stabbing back pain in left shoulde... Read more
Vaccine 2nd dose on Friday May 7th, 2021, Saturday may 8,2021 had stabbing back pain in left shoulder blade, shot was in left arm and shortness of breath, went to clinic on 5/9/21, xray of left arm showed nothing, diagnosed as possible muscle strain, took 1-Norco and 1 tramadol on 5/9/21 & 5/10/21 same pain and shortness of breathe continued by May 12, 2021 at estimated 2pm est I went back to clinic, had 1 puff of Ventolin HFC, my Dr was on vacation, and different doctor saw me and did chest xray- it was okay he told me my heartrate was too high at 120 and go to the Hospital ER, gave me notes and I went to Emergency. I had blood drawn, a cat scan of the lungs, (no clots) and a breathing treatment. The shortness of breathe stopped that evening, the early morning of May 13, 2021 I had a lot of head drainage and chest congestion was breaking up, May 13,2021, May 14, 2021 loose bowels, May 15, 2021 still feeling of confusion and by Saturday May 15,2021 feeling better
69 2021-05-15 platelet count decreased Chief Complaint Fever History of Present Illness This is a 69 year old female with breast cancer s... Read more
Chief Complaint Fever History of Present Illness This is a 69 year old female with breast cancer status post left mastectomy, diabetes mellitus, hypertension, and past transient ischemic attack who presented to ED for fever. The patient reports that she began experiencing sudden onset of fever and chills last night (05/15/2021), and she additionally complains of persistent sore throat and cough beginning the previous week. She has undergone radiation and chemotherapy treatment for breast cancer in the past but these treatments have been suspended for several months with mammography performed on 03/10/2021 failing to identify any malignant growths. In the ED, the patient was found to have acute bronchitis due to COVID-19, fevers and systemic inflammatory response syndrome. Review of Systems Constitutional: Positive for chills and fever. HENT: Positive for sore throat. Respiratory: Positive for cough. Negative for shortness of breath. Cardiovascular: Negative for chest pain and leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Negative for gait problem. Neurological: Negative for syncope. All other systems reviewed and are negative. Vitals Blood pressure 123/75, pulse 95, temperature 37.1 °C (98.7 °F), temperature source Oral, resp. rate 29, height 1.651 m (5' 5"), weight 106.6 kg, SpO2 95 %. Physical Exam Vitals reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is morbidly obese. She is not ill-appearing. HENT: Head: Normocephalic and atraumatic. Nose: Congestion present. Mouth/Throat: Mouth: Mucous membranes are dry. Dentition: Abnormal dentition. Pharynx: Oropharynx is clear. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Chest: Comments: Port in place to the upper right chest. Abdominal: General: Bowel sounds are normal. There is no distension. Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion and neck supple. Skin: General: Skin is warm and dry. Comments: Chronic venous stasis changes to the bilateral lower extremities. Decreased skin turgor throughout. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Plan Admit to hospital ? cardiac telemetry unit Continuous pulse oximetry and telemetry monitoring Control pain, nausea and vomiting as needed Respiratory treatments (MDI) and supplemental oxygen prn IVF hydration; serial neurological checks every four hours Initiate dexamethasone therapy 6 mg IV once daily Ascorbic acid, zinc sulfate, and vitamin D3 supplementation Serial BMP, Mag, CBC, hepatic panel; ESR/CRP, PT/INR Serial lactic acid and procalcitonin; check respiratory PCR Follow up on blood cultures as available; check urinalysis Electrolyte correction/replacement as indicated Fall precautions; PT/OT evaluations during this visit FSBS and SSI every AC/HS for glycemic control Resume selected home medications with hold parameters DVT prophylaxis ? SCDs only GI prophylaxis ? Famotidine
69 2021-05-17 cardiac arrhythmia Heart gave a thus at 11pm and I started with PVC?s that gave continue in NC a daily basis
69 2021-05-19 pulmonary embolism Shortness of breath with sudden onset. Seen at physican office . Chest CT, Echo, PFT ordered. Bila... Read more
Shortness of breath with sudden onset. Seen at physican office . Chest CT, Echo, PFT ordered. Bilateral pulmonary emboli discovered . Eloquis started. Improvement seen. Sats and increased HR improved. Persistent coughing still remains. Patient to remain on Eloquis for 6 mon minimum .
69 2021-05-19 fainting Dizziness and fainting the morning following the 2nd vaccination dose. Red and swollen blotch at in... Read more
Dizziness and fainting the morning following the 2nd vaccination dose. Red and swollen blotch at injection site.
69 2021-05-20 chest discomfort Had me wait 15 mins after injection. Came home started getting dizzy, lasted about a hour. Have bee... Read more
Had me wait 15 mins after injection. Came home started getting dizzy, lasted about a hour. Have been itching all over(inside nose, mouth, eyes and body) with no rash that can be seen, still am. Yesterday till this morning: Pressure on my throat, like someone is pushing on it with their finger, but can drink and swallow, very uncomfortable. Tightness around my chest, like the beginning of a asthma attack. Pains in my abdomen. Throat very dry, had to keep drinking water. Left ankle swelled and hurt. My ears always ring, but they stopped ringing for about 12 hours, which was a blessing, but they are back ring now. Arm is sore. Upset stomach.
69 2021-05-20 pulmonary embolism patient with bilateral PEs with right heart strain - reported SOB since the time of the second COVID... Read more
patient with bilateral PEs with right heart strain - reported SOB since the time of the second COVID vaccination - plan for EKOS catheter tomorrow and treatment with Eliquis
69 2021-05-21 atrial fibrillation Atrial fibrilation, new onset, 4 hours in ER with IV and multiple meds to regulate . Follow up with ... Read more
Atrial fibrilation, new onset, 4 hours in ER with IV and multiple meds to regulate . Follow up with Echo, 2 weeks heart monitor, see cardiologist, blood thinner medication
69 2021-05-22 deep vein blood clot My sister got her first covid shot on 1/25/21. On 1/27/21 she started a prescription for a diuretic... Read more
My sister got her first covid shot on 1/25/21. On 1/27/21 she started a prescription for a diuretic for swelling from DVT in left leg. On 1/29/21 she called me early in the morning to say she couldn't stand or walk. She hasn't walked since. No idea if this was natural progression of dementia. She did walk into and out of cardiology appointment on 1/7/2021, and was weak at that time.
69 2021-05-23 pulmonary embolism, deep vein blood clot Shortness of breath and calf pains that began about 3 weeks after the second Covid vaccine that turn... Read more
Shortness of breath and calf pains that began about 3 weeks after the second Covid vaccine that turned out to be a DVT and Pulmonary Embolism
69 2021-05-30 fast heart rate, heart rate increased, heart rate irregular Had 2nd vaccine May 7, 2021 had high pulse rate er, sob and knife pain in rear shoulder blade visit... Read more
Had 2nd vaccine May 7, 2021 had high pulse rate er, sob and knife pain in rear shoulder blade visit on May 12, 2021 Cardiac testing was PROBNP 394 pg/ml all testing negative went to ER again on 5/25/21 feeling funny in upper chest (hiatal hernia area) pulse was jumping up then down 125 up 80 down PROBNP was 681 pg/ml with this blood test first vaccine 4/7/21 only had loss of voice again all testing was negative no prior heart issues had tachycardia once taking meloxicam and 7 years ago taking Mobic prescription ant-inflammatory script May be the polyrthylene glycol additive used???
69 2021-06-01 ischaemic stroke Approximately 24 hours after receiving second Moderna vaccine patient developed right sided weakness... Read more
Approximately 24 hours after receiving second Moderna vaccine patient developed right sided weakness which prompted a trip to the emergency room. There a head CT was performed and was negative. Patient was then admitted for further testing and a MRI of the brain performed the following day reveled a acute ischemic stroke. Patient was discharged to acute patient rehab and symptoms improved but have not resolved.
69 2021-06-01 blood clot patient reported a couple weeks after 1st moderna vaccine (she was unsure of date, I guessed on the ... Read more
patient reported a couple weeks after 1st moderna vaccine (she was unsure of date, I guessed on the first page of the report because I had to put an exact date). she began to feel short of breath. eventually went to hospital where she was diagnosed with blood clots in both the legs and lungs. she said dr is saying it was due to the vaccine and told her not to get the second dose. she stayed 5 days in the hospital according to her. had surgery to place a filter for the clots and is now home on oxygen around the clock.
69 2021-06-03 loss of consciousness passed out; she did not get her second shot; severe headache like someone crushed your skull, headac... Read more
passed out; she did not get her second shot; severe headache like someone crushed your skull, headache starts in the morning as mild and by night it goes hard, Headache gets worse when she goes in the sun; extreme and terrible fatigue; no balance; night mare; No quality of life; head is very heavy an it is like it gonna fall off; sensitivity to light is terrible, can barely open her eyes in the sun; sleeping for every other hour; sensitivity to sound is terrible; pain behind the eye; no concentration, trouble catching up with things; dizzy; throwing up constantly in the hospital; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anxiety (mild anxiety). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Anxiety. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VOMITING (throwing up constantly in the hospital). On 20-Mar-2021, the patient experienced BALANCE DISORDER (no balance), NIGHTMARE (night mare), QUALITY OF LIFE DECREASED (No quality of life), HEAD DISCOMFORT (head is very heavy an it is like it gonna fall off), PHOTOPHOBIA (sensitivity to light is terrible, can barely open her eyes in the sun), SOMNOLENCE (sleeping for every other hour), HYPERACUSIS (sensitivity to sound is terrible), EYE PAIN (pain behind the eye), DISTURBANCE IN ATTENTION (no concentration, trouble catching up with things), DIZZINESS (dizzy), HEADACHE (severe headache like someone crushed your skull, headache starts in the morning as mild and by night it goes hard, Headache gets worse when she goes in the sun) and FATIGUE (extreme and terrible fatigue). On 22-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (she did not get her second shot). The patient was hospitalized for 10 days due to LOSS OF CONSCIOUSNESS. The patient was treated with PREGABALIN (LYRICA) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INCOMPLETE COURSE OF VACCINATION (she did not get her second shot) had resolved and LOSS OF CONSCIOUSNESS (passed out), BALANCE DISORDER (no balance), NIGHTMARE (night mare), QUALITY OF LIFE DECREASED (No quality of life), HEAD DISCOMFORT (head is very heavy an it is like it gonna fall off), PHOTOPHOBIA (sensitivity to light is terrible, can barely open her eyes in the sun), SOMNOLENCE (sleeping for every other hour), HYPERACUSIS (sensitivity to sound is terrible), EYE PAIN (pain behind the eye), DISTURBANCE IN ATTENTION (no concentration, trouble catching up with things), DIZZINESS (dizzy), VOMITING (throwing up constantly in the hospital), HEADACHE (severe headache like someone crushed your skull, headache starts in the morning as mild and by night it goes hard, Headache gets worse when she goes in the sun) and FATIGUE (extreme and terrible fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included pain killer and steroid infusion for five days. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
69 2021-06-06 heart rate increased SYMPTOMS: Immediately after receiving the shot, I had red blotches all over body, arms, chest, face,... Read more
SYMPTOMS: Immediately after receiving the shot, I had red blotches all over body, arms, chest, face, legs and feet . My feet felt like they were burning up and my heart rate went up to 96 bpm this Lasted for about 1/2, drank a glass of water felt better. The blotches, burning feet and heart rated continued on and off for it seemed like an hour, this lasted three days.
69 2021-06-06 low blood oxigenation On 5/28/21, patient presented to the ED for SOB and np cough which started 5/24. Patient states chil... Read more
On 5/28/21, patient presented to the ED for SOB and np cough which started 5/24. Patient states chills, subjective fevers, cough, SOB/DOE worsened over th eweek. She is on 2L O2 at home and with exertion her O2 sat would drop into the 70s. Rapid COVID-19 is positive. Admitted with acute on chronic hypoxemic respiratory failure secondary to SARS-CoV-2 pneumonia. Completed remdesivir, cefepime, Zosyn, and azitrhomycin, receiving dexamethasone, intubated 6/1/21 for persistent respiratory failure.
69 2021-06-07 chest discomfort approx 6wks after 2nd vaccine tightness in chest, wheezing on exertion, and eating certain foods app... Read more
approx 6wks after 2nd vaccine tightness in chest, wheezing on exertion, and eating certain foods appeared as allergy. Did not have any of this prior to vaccine. coughing , dry throat still occurring
69 2021-06-07 chest pain Pain in upper arm, pain in hand and fingers, some chest pain, severe pain in left eye and above eye.... Read more
Pain in upper arm, pain in hand and fingers, some chest pain, severe pain in left eye and above eye.... this all seems to have fixed itself for now do not have pain.
69 2021-06-07 heart rate irregular, loss of consciousness, hypertension joints hurting; headaches; very tired for almost a month/ exhausted all the time; I ended up passin... Read more
joints hurting; headaches; very tired for almost a month/ exhausted all the time; I ended up passing out/ I was just gone; allergic reaction; face started to tingle; throat started constricting; nose felt numb; tongue felt numb like tingly sensation; tongue felt numb like tingly sensation; high blood pressure; heart started to beat irregularly; Burning sensation in face; I remember nothing; I didn't get better afterwards; not able to ride bike for 6 miles, which was a daily activity; impending sense of doom like something is horribly wrong/ didn't feel normal/ felt very strange; I had I think temperature; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (I ended up passing out/ I was just gone) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy (Polyethylene glycol), Seafood allergy (allergies to fake crab meat), Allergy (aspartame) and Hypertension. Concomitant products included MONTELUKAST for Allergy, LEVOTHYROXINE and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (I ended up passing out/ I was just gone) (seriousness criterion medically significant), HYPERSENSITIVITY (allergic reaction), PARAESTHESIA (face started to tingle), THROAT TIGHTNESS (throat started constricting), HYPOAESTHESIA (nose felt numb), HYPOAESTHESIA ORAL (tongue felt numb like tingly sensation), PARAESTHESIA ORAL (tongue felt numb like tingly sensation), HYPERTENSION (high blood pressure ), HEART RATE IRREGULAR (heart started to beat irregularly), BURNING SENSATION (Burning sensation in face), MEMORY IMPAIRMENT (I remember nothing), ILLNESS (I didn't get better afterwards), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to ride bike for 6 miles, which was a daily activity), FEELING ABNORMAL (impending sense of doom like something is horribly wrong/ didn't feel normal/ felt very strange), PYREXIA (I had I think temperature), HEADACHE (headaches) and FATIGUE ( very tired for almost a month/ exhausted all the time). On 03-Apr-2021, the patient experienced ARTHRALGIA (joints hurting). The patient was treated with PARACETAMOL (TYLENOL) (oral) on 13-Apr-2021 at a dose of 2 Tab twice a day; PARACETAMOL (TYLENOL) at a dose of 1 Tab twice a day; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 13-Apr-2021 at a dose of 25 milligram twice a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 milligram once a day. On 02-Apr-2021, LOSS OF CONSCIOUSNESS (I ended up passing out/ I was just gone) had resolved. On 02-May-2021, FATIGUE ( very tired for almost a month/ exhausted all the time) had resolved. At the time of the report, HYPERSENSITIVITY (allergic reaction), PARAESTHESIA (face started to tingle), THROAT TIGHTNESS (throat started constricting), HYPOAESTHESIA (nose felt numb), HEART RATE IRREGULAR (heart started to beat irregularly), BURNING SENSATION (Burning sensation in face), MEMORY IMPAIRMENT (I remember nothing), ILLNESS (I didn't get better afterwards), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to ride bike for 6 miles, which was a daily activity), FEELING ABNORMAL (impending sense of doom like something is horribly wrong/ didn't feel normal/ felt very strange), PYREXIA (I had I think temperature), ARTHRALGIA (joints hurting) and HEADACHE (headaches) was resolving, HYPOAESTHESIA ORAL (tongue felt numb like tingly sensation) and PARAESTHESIA ORAL (tongue felt numb like tingly sensation) had resolved and HYPERTENSION (high blood pressure ) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) Blood pressure was high, Systolic was 200, diastolic was also high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications also included anti-hypertensives. For treatment of events, patient was prescribed Prednisone, which was not yet started. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
69 2021-06-08 hypertension Around 10 minutes after receiving the first dose, I started feeling woozy, hot, and just very unwell... Read more
Around 10 minutes after receiving the first dose, I started feeling woozy, hot, and just very unwell. I was still at the treatment sight, and the pharmacist just had me sit and wait a few mins. My face was all red like I had a sunburn. They took my Blood pressure and it was really high. So I waited over an hour, and they called the ambulance and they redid by BP, it was a little lower but still high. After a couple of hours I went back home and I was okay. I had a virtual visit with my Dr. after a week later, for, I felt better but still felt bad. I started getting twitches in my belly and left side of my head. The Dr. said he didn't think the vaccine had anything to do with it and that I could go ahead and get my second dose. But after two weeks, I was feeling like I was trembling, and still had muscle twitches. I physically went to the Dr. after these symptoms came back and he recommend that I do NOT get the second dose. So I didn't get it. I told the pharmacist about my reactions etc. I'm still not fully recovered.
69 2021-06-09 low blood oxigenation, pulmonary embolism, cardiac arrest Only reporting to VAERS as patient received covid-19 vaccination under EUA and was hospitalized and ... Read more
Only reporting to VAERS as patient received covid-19 vaccination under EUA and was hospitalized and is now deceased from illness deemed UNRELATED to prior covid-19 vaccination. She was a 69 yr old female who was transferred to hospital on 6/8 at 0141 from outside hospital with severe shock, acute hypoxemic respiratory failure, who had a cardiac arrest on arrival here for 5 mins, during arrest CPR was done and 2 doses of epinephrine were administered prior to ROSC and targeted temperature management was initiated. She was found to have a massive PE, alteplase was given and a heparin continuous infusion was started on 6/8 at 0154 and 0345, respectively. She later underwent a thrombectomy on 6/8 at 1640. She showed signs of poor neurological status. Went into MSOF despite aggressive supportive care. Family requested to make her comfortable and the patient expired on 6/10 at 0449.
69 2021-06-10 chest pain Pain in my left breast/chest
69 2021-06-11 deep vein blood clot, pulmonary embolism Deep venous thrombosis and bilateral pulmonary embolism approximately one week after administration ... Read more
Deep venous thrombosis and bilateral pulmonary embolism approximately one week after administration of vaccine leading to hospitalization on 4/24/21
69 2021-06-11 blood clot blood clots from the knee to top of her leg.; feeling uncomfortable; This spontaneous case was repor... Read more
blood clots from the knee to top of her leg.; feeling uncomfortable; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots from the knee to top of her leg.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypercholesterolemia. Concurrent medical conditions included Diabetes and Hypertension. On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced THROMBOSIS (blood clots from the knee to top of her leg.) (seriousness criterion medically significant) and MALAISE (feeling uncomfortable). At the time of the report, THROMBOSIS (blood clots from the knee to top of her leg.) and MALAISE (feeling uncomfortable) outcome was unknown. Very limited information regarding this event/s has been provided at this time. Further information is not expected. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information is not expected.
69 2021-06-14 chest pain, pulmonary embolism, blood clot large blood clot in the right lung/smaller blood clot in the left lung; blood clot in the calf of th... Read more
large blood clot in the right lung/smaller blood clot in the left lung; blood clot in the calf of the left leg; Baker's cyst behind the left knee; "I still didn't feel right or good"; "problems with my kidneys"; dull pain; "really bad chest pains"; "knee got swollen up"; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung) and THROMBOSIS (blood clot in the calf of the left leg) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included LOSARTAN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), OMEPRAZOLE, EZETIMIBE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), VITAMIN D [VITAMIN D NOS], CALCIUM, MULTIVITAMINS [VITAMINS NOS] and APIXABAN (ELIQUIS) for an unknown indication. On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced JOINT SWELLING ("knee got swollen up"). On 26-Apr-2021, the patient experienced PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung) (seriousness criteria hospitalization and medically significant) and CHEST PAIN ("really bad chest pains"). On an unknown date, the patient experienced THROMBOSIS (blood clot in the calf of the left leg) (seriousness criterion medically significant), SYNOVIAL CYST (Baker's cyst behind the left knee), MALAISE ("I still didn't feel right or good"), RENAL PAIN ("problems with my kidneys") and PAIN (dull pain). At the time of the report, PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung), THROMBOSIS (blood clot in the calf of the left leg), JOINT SWELLING ("knee got swollen up"), SYNOVIAL CYST (Baker's cyst behind the left knee), MALAISE ("I still didn't feel right or good"), CHEST PAIN ("really bad chest pains"), RENAL PAIN ("problems with my kidneys") and PAIN (dull pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Company comment: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
69 2021-06-15 blood glucose increased ongoing fatigue and exhaustion for more than 2 weeks. during the afternoon, relieved temporarily wit... Read more
ongoing fatigue and exhaustion for more than 2 weeks. during the afternoon, relieved temporarily with sleep and rest.
69 2021-06-15 stroke, hypertension, heart rate increased Rapid onset vision loss in left eye with concurrent rapid onset high blood pressure and rapid pulse.... Read more
Rapid onset vision loss in left eye with concurrent rapid onset high blood pressure and rapid pulse. Testing showed existing crowded optic nerve (previously undiagnosed), swelling of the optic nerve, delayed blood flow to optic nerve, and leakage around optic nerve head. Vision loss progressed over about five days, stabilized, and may now be somewhat improved. Diagnosis is Non-Arteric Ischemic Optic Neuritis (NAION), for which there is no treatment and uncertain prognosis. Some extent of permanent vision loss tis epected. Concurrent rapid onset of hypertension (systolic 150s-170s; diastolic low 100s at times) and fluctuating rapid pulse (80s-110). Currently being treated for hypertension but not yet fully controlled. Blood tests revealed elevated inflammatory markers (high C-reactive protein and sedimentation rate and positive ANA. Follow-up tests to determine cause of hypertension are underway. Thus far, no heart abnormalities, no carotid artery blockage, and negative for a number of autoimmune disorders and other possible causes. Prior to this event, blood pressure and pulse were normal and eye exams showed no vision or retina problems, glaucoma, or macular degeneration. Cardiologist and rheumatologist have not ruled out inflammatory response to Covid vaccine, have encouraged reporting of this event to VAERS, and have advised against taking any other Covid booster. Note that the optometrist who first saw me when the vision loss began has since told me that he saw only two cases of NAION in 38 years of practice before mine, but has seen two more besides me in the last couple of months. Both were patients of similar age with similar rapid onset of vision loss, and both had taken the Covid vaccine about four weeks before.
69 2021-06-16 heart flutter, cardiac arrhythmia Almost a month after the vaccination I started to feel heart flutters, toward the bottom of my heart... Read more
Almost a month after the vaccination I started to feel heart flutters, toward the bottom of my heart it was flutter. I have never felt flutters like this before. It was off and on throughout the day for like 10 to 15 minutes at a time. I went to the doctor after a couple of weeks because one day I had the flutters for over an hour and it didn't seem like it was stopping. At the urgent care they did an EKG and sent me to the Emergency Room and it stopped and told me to see a cardiologist. OnEaster, the fluttering started while I was asleep , I sat up and it continued and it wasn't stopping. In the morning it was still present. So I went to the Emergency Room , they kept me there most of the day, at 3:00 they decided to keep me overnight. They diagnosed me with ventricular trigeminy. The doctor increased my metoprolol. My cardiologist at a later appointment increased the metoprolol to 200 mg .
69 2021-06-17 palpitations, palpitations 5/17/21: Left groin lymph node extremely tender and painful on touch. Symptoms lasted about 5 days... Read more
5/17/21: Left groin lymph node extremely tender and painful on touch. Symptoms lasted about 5 days Skin/bumps eruption between buttocks, sore & itchy. I applied OTC Cortisone. Symptoms lasted 7 days. Ear ache, itchy, clogged, moist. Applied previously prescribed drops:Fluocinolone Acetonide oil Fatigue (only lasted one day) * Irregular heartbeat. Heart muscle gradually tightening then a thump followed by heart skipping a beat and then light palpitations. Lasted 5 days. On and off throughout the day and night. No pain. Tingling left side of neck w/ muscle soreness; traveled down to shoulder and up to behind right ear. Symptoms continuing to present day.
69 2021-06-18 heart rate irregular Heartbeat irregularities
69 2021-06-19 atrial fibrillation, heart rate increased, heart flutter Went to the ER the evening of March 25 with Rapid AFib. Had pulse rate ranging from 160 - 205. Heart... Read more
Went to the ER the evening of March 25 with Rapid AFib. Had pulse rate ranging from 160 - 205. Heart was ?flopping?. Treated with medications and sent home.
69 2021-06-20 hypotension, low platelet count, fast heart rate, fainting, haemoglobin decreased, heart attack Patient is a 69-year-old female with a past medical history significant for type 2 diabetes, hyperte... Read more
Patient is a 69-year-old female with a past medical history significant for type 2 diabetes, hypertension, RA, GERD who presented from a rehab facility with fevers, hypotension, tachycardia and diarrhea. This is the patient's third hospitalization in the last month. She was initially admitted on 5/4/2021 for she suffered to syncopal episodes resulting in a motor vehicle accident x 2. From 5/4-5/6. During that admission her gabapentin dose was decreased and she was given 5 days of Macrobid on discharge for a possible urinary tract infection. We also arrange follow-up with cardiology for loop recorder and to see orthopedics as an outpatient the etiology for her syncopal episode was unclear. It was not felt to be seizure related. She went home with home health care. She unfortunately was readmitted on 5/29-6/3 new onset acute pancreatitis with an unknown etiology and was ultimately discharged to rehab. During that hospitalization patient reported that she was seen by cardiology for her 2 syncopal episodes that occurred earlier in the month and a cardiac cause of her syncope was ruled out and they recommended she be referred to neurology. She returns back again for admission on 6/8 for encephalopathy, hypotensive, septic shock, NSTEMI and was subsequently admitted to the intensive care unit on pressor support. She was given Cipro, Flagyl, Vanco and Levophed and IV fluids. Her septic shock was felt secondary to urinary tract infection. The urine culture that was resulted on 5/30 grew Klebsiella pneumonia that was resistant to Macrobid. She was not sent out on any antibiotic therapy as she was not felt to be symptomatic during her last hospital course. She also had a CAT scan during this hospital course which showed colitis. Urine culture from this admission was of mixed flora Greater than 100,000 colony-forming units no organisms were grown out however. She was treated with 7 days of Cipro. Again patient's CAT scan of the abdomen and pelvis done on admission showed colitis she was seen by gastroenterology during her hospital stay and underwent an endoscopy. It was ultimately felt that the patient's colitis was likely ischemic in nature. Patient was also noted to be thrombocytopenic on admission which was felt to be possibly from sepsis or dilution was ultimately resolved at the point of discharge. She also again was found to have acute blood loss anemia with no source found. she had hematochezia noted on admission but resolved by the point of discharge. EGD did not reveal any source of bleeding other than a tiny esophageal ulcer. Aspirin therapy was discontinued. She did not need transfusion during her hospital stay. The lowest her hemoglobin went was to 7.3. Patient's acute tubular necrosis resolved her metabolic acidosis and metabolic encephalopathy resolved and at this point she is stable for discharge to rehab. Patient's lisinopril aspirin, hydrochlorothiazide have been discontinued at this point. Her blood pressure is 121/61 she is afebrile respirations are normal O2 sat is 95% on room air. Patient's hemoglobin is 8.1. She is no longer having an abdominal pain and is tolerating p.o. She is not having any diarrhea. the cause for the patient's colitis is likely ischemic in nature. she was discharged to rehab on 6/15
69 2021-06-20 pulmonary embolism Massive pulmonary embolism, pulseless electrical activity
69 2021-06-21 hypertension This spontaneous case was reported by a consumer and describes the occurrence of AORTIC STENOSIS (ao... Read more
This spontaneous case was reported by a consumer and describes the occurrence of AORTIC STENOSIS (aortic stenosis) and MITRAL VALVE PROLAPSE (mitral valve prolapse) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Ex-smoker (smoked for 40 years) and Benign lung neoplasm in 2019. Concurrent medical conditions included COPD, Asthma (since childhood), Depression, Sleep disorder, Acid reflux (esophageal) and High cholesterol. Concomitant products included FAMOTIDINE for Acid reflux (oesophageal), ALBUTEROL [SALBUTAMOL] for COPD, BUPROPION and VALPROATE SEMISODIUM (DIVALPROEX) for Depression, FENOFIBRATE and PRAVASTATIN for High cholesterol, CLONAZEPAM for Sleep disorder. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 16-Mar-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). On 22-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath) and MUSCULOSKELETAL STIFFNESS (Stiff neck). On an unknown date, the patient experienced AORTIC STENOSIS (aortic stenosis) (seriousness criterion medically significant), MITRAL VALVE PROLAPSE (mitral valve prolapse) (seriousness criterion medically significant), DYSPNOEA EXERTIONAL (A little activity winds the patient), HYPERTENSION (blood pressure high) and COORDINATION ABNORMAL (has trouble chopping vegetables). The patient was treated with UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA) ongoing since an unknown date for Asthma, at an unspecified dose and frequency; PREDNISONE for Symptomatic treatment, at an unspecified dose and frequency and IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. On 16-Mar-2021, CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, AORTIC STENOSIS (aortic stenosis), MITRAL VALVE PROLAPSE (mitral valve prolapse), DYSPNOEA (Shortness of breath), MUSCULOSKELETAL STIFFNESS (Stiff neck), DYSPNOEA EXERTIONAL (A little activity winds the patient), HYPERTENSION (blood pressure high) and COORDINATION ABNORMAL (has trouble chopping vegetables) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) increased. On an unknown date, Computerised tomogram: abnormal (abnormal) negative for cancer, , sugar spots found on her lungs 2 years prior were a little bit bigger. On an unknown date, Echocardiogram: abnormal (abnormal) mitral valve prolapse and aortic stenosis. On an unknown date, Oxygen saturation: 96 (normal) after walk laps over6 minutes ( 95-97). Patient stated that she is calling to provide an update on her condition. She stated that she forgot to mention on her previous call that her primary care physician put her on Prednisone 40mg daily for 5 days. She stated that she was more comfortable but it did not help her breathing. She then saw a Pulmonologist on 9Jun2021. She stated that she smoked for 40 years, so the pulmonologist wanted to do a cat scan to rule out lung cancer and none was found. He did find that the "sugar spot on her lungs", which was found 2 years prior, was a little bigger but not concerning to him. He took her oxygen level (96) and then had her walk laps around his office for 6 minutes. Her oxygen level then ranged between 95-97, so did did not need to be on supplemental oxygen. He then did an echocardiogram and diagnosed her with mitral valve prolapse and aortic stenosis. She stated that her blood pressure is now high and she is seeing a cardiologist on 19Jul2021. She stated that she thinks the vaccine accelerated these things and she's been in a living for 3 months. She stated that she used to only had to use her albuterol inhaler 3 or 4 times a year. She pants just sitting in chair and has trouble chopping vegetables. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. There is confounding by chronic obstructive pulmonary disease, asthma and history of smoking. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Treatment medication, reported events updated. Case became serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. There is confounding by chronic obstructive pulmonary disease, asthma and history of smoking.
69 2021-06-21 ischaemic stroke, cerebrovascular accident, atrial fibrillation 03-29-2021 at 8:30am awoke with severe headache, left jaw pain and vision problem. Made appointment ... Read more
03-29-2021 at 8:30am awoke with severe headache, left jaw pain and vision problem. Made appointment with eye doctor (April 1) . 03-30-2021, while shopping had a major stroke at 1:00pm. EMS took me to the Hospital. Admitted to ER, acute ischemic stroke, basilar artery thrombosis, atrial fibrillation. Blood clot removal by Neurological Radiologist. Discharged from Hospital April 2,2021. Still am being treated for atrial fibrillation and vision problems.
69 2021-06-21 inflammation of the pericardium, chest discomfort, fluid around the heart About 2 months after the 2nd dose vaccine, I started getting shortness of breath and tightness in my... Read more
About 2 months after the 2nd dose vaccine, I started getting shortness of breath and tightness in my chest. Around end of May, the pressure started getting heavier. By June 5, 2021 I thought I was having a possible heart attack, so I decided to go to the Hospital. They did a bunch of tests and an ECHO and detected pericarditis, pericardio effusion and blood clots. I was on a heparin drip for 7 days for the blood clot and they started me on colchicine for the pericarditis which has now resolved. I was discharged with RX for Lovenox to prevent blood clots and to continue to take colchicine. I was in the hospital for 8 days total.
69 2021-06-22 hypertension Some hearing loss on right side after 2nd dose; Felt so bad she thought she was going to need an amb... Read more
Some hearing loss on right side after 2nd dose; Felt so bad she thought she was going to need an ambulance after 2nd dose; Got up and lost her balance after 2nd dose; Vertigo after 2nd dose; Pressure in ears after 2nd dose; Ringing in right ear after 2nd dose; Blood pressure went up after the vaccine; Headaches after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Some hearing loss on right side after 2nd dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced DEAFNESS (Some hearing loss on right side after 2nd dose) (seriousness criterion medically significant), FEELING ABNORMAL (Felt so bad she thought she was going to need an ambulance after 2nd dose), BALANCE DISORDER (Got up and lost her balance after 2nd dose), VERTIGO (Vertigo after 2nd dose), EAR DISCOMFORT (Pressure in ears after 2nd dose), TINNITUS (Ringing in right ear after 2nd dose), HYPERTENSION (Blood pressure went up after the vaccine) and HEADACHE (Headaches after 2nd dose). At the time of the report, DEAFNESS (Some hearing loss on right side after 2nd dose), FEELING ABNORMAL (Felt so bad she thought she was going to need an ambulance after 2nd dose), BALANCE DISORDER (Got up and lost her balance after 2nd dose), VERTIGO (Vertigo after 2nd dose), EAR DISCOMFORT (Pressure in ears after 2nd dose), TINNITUS (Ringing in right ear after 2nd dose), HYPERTENSION (Blood pressure went up after the vaccine) and HEADACHE (Headaches after 2nd dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood pressure measurement: elevated (High) BP was123-127 and it got elevated after vaccination.. Concomitant medication were not provided.Treatment information was not provided. The patient reported that it took eight weeks to recover and became normal from the events. Action taken with mRNA-1273 in response to the event were not applicable. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
69 2021-06-22 loss of consciousness This morning I still felt bad but not as bad, felt exhausted; Still feel drained right now and sore,... Read more
This morning I still felt bad but not as bad, felt exhausted; Still feel drained right now and sore, achy; Having aches; Chills; Passed out, became unconscious; Generally not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out, became unconscious) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included DRONEDARONE HYDROCHLORIDE (MULTAQ), RISPERIDONE, METOPROLOL, APIXABAN (ELIQUIS), TEMAZEPAM and TOPIRAMATE for an unknown indication. On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out, became unconscious) (seriousness criterion medically significant), MALAISE (Generally not feeling well), MYALGIA (Having aches) and CHILLS (Chills). On 13-Jun-2021, the patient experienced FATIGUE (This morning I still felt bad but not as bad, felt exhausted) and MYALGIA (Still feel drained right now and sore, achy). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 13-Jun-2021, LOSS OF CONSCIOUSNESS (Passed out, became unconscious), MALAISE (Generally not feeling well), MYALGIA (Having aches) and CHILLS (Chills) had resolved. At the time of the report, FATIGUE (This morning I still felt bad but not as bad, felt exhausted) and MYALGIA (Still feel drained right now and sore, achy) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment include fluids. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
69 2021-06-22 pulmonary embolism Patient stated that she received her 2nd COVID vaccine on April 23rd and since then has had progress... Read more
Patient stated that she received her 2nd COVID vaccine on April 23rd and since then has had progressive shortness of breath with exertion. She said that the shortness of breath was so bad she had to come to ED for further evaluation. Found to have pulmonary embolisms. Treated with heparin drip at outside ER and then transitioned to enoxaparin 1 mg/kg BID. On day 2 of admission, patient transferred to a tertiary center for possible catheter directed TPA/Thrombectomy due to her right heart strain and patient feeling dizzy when she moves.
69 2021-06-23 chest discomfort Heart attack-like symptoms: pain down both arms, heavy chest
69 2021-06-23 palpitations I have been extremely nauseous, had extreme aches, extreme dizziness and light headedness, and heada... Read more
I have been extremely nauseous, had extreme aches, extreme dizziness and light headedness, and headache. Heart races.
69 2021-06-23 fluid around the heart Pericardial effusion, shortness of breath, started within 2 weeks after 2nd vaccine
69 2021-06-23 blood clot, ischaemic stroke a month later she had thrombotic event- she had a central artery embolism to her right eye and multi... Read more
a month later she had thrombotic event- she had a central artery embolism to her right eye and multiple small ischemic strokes in multiple areas of her brain. she lost vision in her eye,
69 2021-06-23 cardiac arrhythmia, arrhythmia, fast heart rate Acute onset of Tachycardia 120-130 and SOA six hours post second vaccine sustained for 11 hours in... Read more
Acute onset of Tachycardia 120-130 and SOA six hours post second vaccine sustained for 11 hours initially. Arrhythmias and SOA continue with events ranging from seconds to hours. Tachycardia, Burst of PVCs Resting HR normal is 50-60s now in 80s a high percentage of the time. Slight blurry vision but has improved.
69 2021-06-24 loss of consciousness Felt high later in day and into night 2:30am got up to use restroom returning to bed passed out tryi... Read more
Felt high later in day and into night 2:30am got up to use restroom returning to bed passed out trying to into bed passed out again took things slow next day and stayed in bed and ate very little mon-wed getting better each day thur felt like I was going to pass out again called Dr and said sound like I was getting better if I pass out go straight to ER It took a good week to get back to normal
69 2021-06-24 inflammation of the heart muscle 1st shot myocarditis 2nd fever , chills hard to get out of bed
69 2021-06-27 blood pressure increased Loss of taste & smell (continues), Severe fatigue (continues), Severe headache for 4 days, recurrent... Read more
Loss of taste & smell (continues), Severe fatigue (continues), Severe headache for 4 days, recurrent headaches when fatigue increases (continues), Elevate Blood pressure 3.5 weeks, Numbness in tip of tongue, lips & fingertips (2 days), extreme dryness of hair, scalp and skin & lips, hair breakage 3 weeks, brain fog for 6 days, change in vision 2 weeks, nausea & diarrhea day 4 & 5, low grand temperature 6 days, loss of appetite (continues), rash and itching legs, back & arms (continues on thighs but controlled with Benadril -unable to take adult Benadril), pain in joints, especially hips, elbows, knees & shoulders) for 3 weeks, aching muscles 2 weeks,
69 2021-06-27 cardiac arrest, oxygen saturation decreased The day she received the second dose she started with flu like symptoms. She also had tingling hands... Read more
The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it.
69 2021-06-27 chest pain Chills, fever, chest pains, muscle aches, headache, exhaustion, slightly elevated white blood count.
69 2021-06-28 deep vein blood clot wheezing same day as vaccine- albuterol hfa and prednisone dyspnea exacerbated over next several day... Read more
wheezing same day as vaccine- albuterol hfa and prednisone dyspnea exacerbated over next several days leg deep venous thrombosis developed/diagnosed 11 days later
69 2021-06-29 heart rate decreased I had the second dose on 6/22/2021 and my symptoms got worse after the COVID shot, it exacerbated ev... Read more
I had the second dose on 6/22/2021 and my symptoms got worse after the COVID shot, it exacerbated everything that was wrong with me, my kidneys function went down, they got compromised, I was not peeing much, I had pain on my neck, horrible ear symptoms of ringing and high pitch sound. It lasted for a day. Hip and joint pain, my knee hurt me a lot. I was weak and unable to do a lot of things. My heart rate went down, my potassium went up. I ended up in the hospital and they admitted me for 4 days. They kept taking blood every day and my sugar levels. They gave me heparin.
69 2021-06-29 palpitations Hands was sore the next day after couldn't move from bed. Ok for for a month then got shortness of b... Read more
Hands was sore the next day after couldn't move from bed. Ok for for a month then got shortness of breath and start having heart palpitations and headaches sometimes
69 2021-06-29 lightheadedness I am experiencing a bad case of diarrhea since the end of April and have been into the Doctor severa... Read more
I am experiencing a bad case of diarrhea since the end of April and have been into the Doctor several times and all the tests run came back negative. I'm on anti-diarrhea medication (Lomotil) which is helping somewhat but I don't like taking medicine because I have to rely on the medication to perform my daily routine plus having to wear pads all the time is an inconvenience for me. I had to go to the ER because I had a episode of near fainting.
69 2021-07-01 cerebrovascular accident, heart attack, chest pain 6-14-2021 left arm pain and numbness 6-18-2021 massive stroke (right hemi) 6-22-2021 heart attack 6-... Read more
6-14-2021 left arm pain and numbness 6-18-2021 massive stroke (right hemi) 6-22-2021 heart attack 6-26-2021 unspecified seizure 6-27-2021 severe chest pain 6-28-2021 shingles outbreak 6-29-2021 salmonella & staph infections detected 7-1-2021 unspecified blood in stool Extreme confusion throughout this time
69 2021-07-01 chest pain Patient stated that she had bad burning in her arm. She had a rash on her arm. Pain in her shoulder.... Read more
Patient stated that she had bad burning in her arm. She had a rash on her arm. Pain in her shoulder. Further down her arm was swollen. Started getting nausea and dizzy. Patient also started experiencing chest pain. She called 911. they took her to the hospital. the text came back normal. She started to feel better. Spoke to pharmacist who advised patient not to take second shot until she has seen cardiologist.
69 2021-07-01 increased heart rate, lightheadedness The patient c/o dizziness. Has history of diabetes and HTN. Reported that she took her BP medication... Read more
The patient c/o dizziness. Has history of diabetes and HTN. Reported that she took her BP medication Losartan 80mg this morning prior to walking from her development approximately 1 .5 miles and has been waiting for about an hour and a half to receive the vaccine. BP initially 160/92 heart rate 98 then increased to 188/96. Patient reports that she feels as if she is going to pass out. Repeat BP166/83.EKG =Sinus tach. The patient requested to be transferred to the ED for further evaluation. 911called and patient transported via fire rescue/paramedics without incidence.
69 2021-07-05 chest discomfort, inflammation of the heart muscle myocarditis; Patient received 2nd dose 23 days after the first; a little sensitivity if she touched ... Read more
myocarditis; Patient received 2nd dose 23 days after the first; a little sensitivity if she touched the injection site; heavy pressured feeling on her chest; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMINS NOS for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced CHEST DISCOMFORT (heavy pressured feeling on her chest). On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 23 days after the first) and VACCINATION SITE DYSAESTHESIA (a little sensitivity if she touched the injection site). At the time of the report, MYOCARDITIS (myocarditis), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 2nd dose 23 days after the first), VACCINATION SITE DYSAESTHESIA (a little sensitivity if she touched the injection site) and CHEST DISCOMFORT (heavy pressured feeling on her chest) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication was given. Patient had on allergy pills as concomitant medication. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-237410 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
69 2021-07-08 palpitations, enlargement of the heart Heart palpitations; Shortness of breath; May be I have an enlarged heart; This spontaneous case was ... Read more
Heart palpitations; Shortness of breath; May be I have an enlarged heart; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and DYSPNOEA (Shortness of breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stroke since 2012. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations), DYSPNOEA (Shortness of breath) and CARDIOMEGALY (May be I have an enlarged heart). The patient was treated with ROSUVASTATIN ongoing since an unknown date at a dose of Daily. At the time of the report, PALPITATIONS (Heart palpitations), DYSPNOEA (Shortness of breath) and CARDIOMEGALY (May be I have an enlarged heart) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood cholesterol: high (High) Dose of rosuvastatin was increased from 5 mg to 10 mg daily.. In May 2021, Cardiac stress test: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had the events after 1 month of second vaccine. Patient had 2 stress tests that did not had a clear results. Stress test performed. It was reported that, palpitations and shortness of breath was occurring 4-5 times a day and though she might have enlarged heart. After receiving the vaccine, Rosuvastatin was increased to 10 mg daily. An angiogram was schedule on the Tuesday following this report. Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Event description was updated.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
69 2021-07-12 atrial fibrillation, fibrin d dimer increased 7/12/21 er @ hospital: 69 y.o. female who presents with increasing shortness of breath. Patient rep... Read more
7/12/21 er @ hospital: 69 y.o. female who presents with increasing shortness of breath. Patient reports increasing shortness of breath for the past 3 days. She denies any runny nose or sinus congestion. Patient does report a dry cough but states it is no different from her typical COPD cough. Patient denies any chest pain or palpitations. However, patient on bedside monitor is in AFib with RVR. Patient does voice a history of intermittent atrial fibrillation. Patient denies any current palpitations, chest pain, or edema. Of note, patient reports she sustained a stroke approximately 6 weeks ago. Patient reports she experienced left-sided weakness. She reports that left-sided weakness has since returned to completely normal. She did not seek medical care for her stroke at the time of the stroke. (pt is a retired nurse) Transferred to another healthcare facility where she remains admitted as of 7/13/21
69 2021-07-12 low blood platelet count, platelet count decreased Patient developed ITP 3 weeks after, severe. Platelets dropped to 1
69 2021-07-13 cerebrovascular accident stroke; Flashers in her eyes that continue; Woke up in the middle of the night several times; This s... Read more
stroke; Flashers in her eyes that continue; Woke up in the middle of the night several times; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ATENOLOL, LEVOTHYROXINE, CHLORTHALIDONE, SIMVASTATIN, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and ACETYLSALICYLIC ACID, CAFFEINE, CHLORPHENAMINE MALEATE (CORICIDIN [ACETYLSALICYLIC ACID;CAFFEINE;CHLORPHENAMINE MALEATE]) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PHOTOPSIA (Flashers in her eyes that continue) and INSOMNIA (Woke up in the middle of the night several times). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Migraine and Headache, at a dose of 1 dosage form four times per day. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), PHOTOPSIA (Flashers in her eyes that continue) and INSOMNIA (Woke up in the middle of the night several times) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CEREBROVASCULAR ACCIDENT (stroke) to be not related. No further causality assessments were provided for PHOTOPSIA (Flashers in her eyes that continue) and INSOMNIA (Woke up in the middle of the night several times). Based on the current available information and temporal association between the use of the product and the start date of the events of photopsia and insomnia, a causal relationship cannot be excluded. Based on reporter's causality the event of cerebrovascular accident is assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant follow received and the initial diagnosis of ocular migraine was wrong and is confirmed to be a stroke. Reporter causality was updated to unrelated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of photopsia and insomnia, a causal relationship cannot be excluded. Based on reporter's causality the event of cerebrovascular accident is assessed as unlikely related to mRNA-1273.
69 2021-07-13 palpitations After i got the vaccination my thyroid is higher; thought the palpitations where from an illness tha... Read more
After i got the vaccination my thyroid is higher; thought the palpitations where from an illness that had on the past, when got for the test from the thyroids and the doctor said the thyroids was high; Illness; This spontaneous case was reported by a patient and describes the occurrence of HYPERTHYROIDISM (After i got the vaccination my thyroid is higher) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism, SIMVASTATIN (SIMVASTIN), VITAMIN D NOS and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTHYROIDISM (After i got the vaccination my thyroid is higher) (seriousness criterion medically significant), PALPITATIONS (thought the palpitations where from an illness that had on the past, when got for the test from the thyroids and the doctor said the thyroids was high) and ILLNESS (Illness). At the time of the report, HYPERTHYROIDISM (After i got the vaccination my thyroid is higher), PALPITATIONS (thought the palpitations where from an illness that had on the past, when got for the test from the thyroids and the doctor said the thyroids was high) and ILLNESS (Illness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood thyroid stimulating hormone: high (High) Thyroid level was High. The patient stop taking the medication for a week . Treatment medication information was provided as "Decreased to 50 mcg from 75 mcg after the high thyroids". Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected.
69 2021-07-13 blood clot After the initial side effects of chills, fever, and body aches subsided I had hot flashes and night... Read more
After the initial side effects of chills, fever, and body aches subsided I had hot flashes and night sweats every night for 5 weeks. Then breast pain and swelling began and breast tissue changes were confirmed on May 28 via ultrasound. Two weeks later I developed a blood clot in my left calf as confirmed by an ultrasound on June 11, 2021. I believe this blood clot was provoked my the Moderna vaccine, as there were no other factors that could have provoked the blood clot.
69 2021-07-14 cardiac arrest, blood glucose increased Early in the morning Saturday, the day after the injection, patient became very nauseaus with a bad ... Read more
Early in the morning Saturday, the day after the injection, patient became very nauseaus with a bad headache. She was sick all day on Saturday with nausea and headache. She could not sleep. On Sunday, she felt worse and called ambulance. They came and checked her out. Said Oxygen level was normal and all her symptoms were normal side effects. They did not take her to the hospital. All day Sunday, she continued to be agitated and not able to get comfortable. She was hot and cold, back and forth. Her headache was very bad and she felt like she would throw up, but only threw up a little that day. By Monday, she started not making sense and slurred her words. We thought this was due to lack of sleep (exhaustion). Her sugar was high, so we gave her an insulin shot. She continued to make less and less sense so we called 911 approximately 7 PM on Monday night. She was hallucinating. At the hospital, they looked for infection, but could not find any source of infection. They intubated her and soon after this, her heart stopped breathing. They performed CPR 3 times, but not successful. She died at 5 AM Tuesday morning.
69 2021-07-14 chest discomfort Extreme severe nausea lasting 48 hours, fever 101.9, chills, extreme weakness, chest pressure. Arm ... Read more
Extreme severe nausea lasting 48 hours, fever 101.9, chills, extreme weakness, chest pressure. Arm extremely red, bruised, hot and swollen. I did not seek medical care although I truly feared I was perhaps experiencing an heart attack. I am my husband's sole caretaker and cannot leave him unattended.
69 2021-07-15 nosebleed, chest pain 1) 911 - On 5/27/2021 at about 7:00pm I started to experience bad chest pain which only increased to... Read more
1) 911 - On 5/27/2021 at about 7:00pm I started to experience bad chest pain which only increased to severe. At 2:00pm I contacted a triage nurse associated with the Hospital, who informed me to hang up and immediately call 911. I did call 911 and paramedics & ambulance arrived. I was given EKG, Nitroglycerine, etc. and transported to the ER department. I was treated by the Dr. Many lab tests were performed including 2 Troponin tests during the course of my stay. A CT scan was done as well. I was told I had chest wall swelling, was treated and released at 5:30am on 5/28/2021. 2) On 6/12/2021 Experienced a large black & blue spot approx 2" x 6" in the left arm at the original injection site. Injection site was small hard lump at the onset. 3) Have been experiencing nose bleeds. (which I have never had before). Note: I have always been extremely healthy and these symptoms are extremely unusual. Have had nothing like this prior to my vaccine. I have had other vaccines in the past with uterly no reactions.....Thank you....
69 2021-07-16 hypertension aortic stenosis; mitral valve prolapse; A little activity winds the patient; blood pressure high; ha... Read more
aortic stenosis; mitral valve prolapse; A little activity winds the patient; blood pressure high; has trouble chopping vegetables; Flu; Shortness of breath; Stiff neck; Headache; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of AORTIC STENOSIS (aortic stenosis), MITRAL VALVE PROLAPSE (mitral valve prolapse) and DYSPNOEA (Shortness of breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Ex-smoker (smoked for 40 years), Benign lung neoplasm in 2019, Breast cancer (had lumpectomy, radiation and took a "chemo pill" for 5 years.) in 2000, Bipolar disorder since 1991, Non-alcoholic steatohepatitis, Mastectomy (Bilateral mastectomy scars with no erythema nodules or masses.) and Knee surgery NOS. Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE POLYSACCH 23V on 29-Dec-2020. Concurrent medical conditions included COPD, Asthma (since childhood), Depression, Sleep disorder, GERD, High cholesterol and Drug allergy (Bactrim( Sulfamethoxazole-trimethoprim), hives). Concomitant products included FAMOTIDINE for Acid reflux (oesophageal), ALBUTEROL [SALBUTAMOL] for COPD, BUPROPION and VALPROATE SEMISODIUM (DIVALPROEX) for Depression, FENOFIBRATE and PRAVASTATIN for High cholesterol, CLONAZEPAM for Sleep disorder, CALCIUM CARBONATE, CHOLECALCIFEROL and POLYETHYLENE GLYCOL 3350 for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced CHILLS (Chills). On 22-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Stiff neck), HEADACHE (Headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced AORTIC STENOSIS (aortic stenosis) (seriousness criterion medically significant), MITRAL VALVE PROLAPSE (mitral valve prolapse) (seriousness criterion medically significant), DYSPNOEA EXERTIONAL (A little activity winds the patient), HYPERTENSION (blood pressure high), COORDINATION ABNORMAL (has trouble chopping vegetables) and INFLUENZA (Flu). The patient was treated with UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA) (oral) from 07-Apr-2021 to 09-Apr-2021 for Asthma, at a dose of 1 dosage form; PREDNISONE (oral) from 30-May-2021 to 04-Jun-2021 for Adverse event, at a dose of 20 mg twice a day and IBUPROFEN for Symptomatic treatment, at a dose of 1 dosage form. On 16-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, AORTIC STENOSIS (aortic stenosis), MITRAL VALVE PROLAPSE (mitral valve prolapse), DYSPNOEA (Shortness of breath), MUSCULOSKELETAL STIFFNESS (Stiff neck), DYSPNOEA EXERTIONAL (A little activity winds the patient), HYPERTENSION (blood pressure high), COORDINATION ABNORMAL (has trouble chopping vegetables), INFLUENZA (Flu), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Blood calcium: 10.4 (High) 10.4. On 07-Apr-2021, Blood chloride: 108 (normal) 108. On 07-Apr-2021, Blood potassium: 4.2 (normal) 4.2. On 07-Apr-2021, Blood pressure measurement: 142/88 (High) 142/88. On 07-Apr-2021, Blood sodium: 145 (normal) 145. On 07-Apr-2021, Carbon dioxide: 26.3 (normal) 26.3. On 07-Apr-2021, Chest X-ray: normal (normal) Upright frontal and lateral chest X-Ray; No acute cardiopulmonary process. On 07-Apr-2021, Haematocrit: 41.9 (Inconclusive) 41.9. On 07-Apr-2021, Haemoglobin: 14.4 (High) 14.4. On 07-Apr-2021, Mean cell volume: 98.2 (Inconclusive) 98.2. On 07-Apr-2021, Platelet count: 208 (Inconclusive) 208. On 07-Apr-2021, White blood cell count: 5.9 (Inconclusive) 5.9. On 21-Apr-2021, Ultrasound abdomen: abnormal (abnormal) Gall bladder filled with stones and sludge without evidence of cholecystitis.. On 03-May-2021, Blood pressure measurement: 169/74 (High) 169/74 Right arm. On 03-May-2021, Body temperature: 35.7 (Inconclusive) 35.7 degrees Celsius. On 03-May-2021, Heart rate: 49 (Inconclusive) 49. In 2021, Blood pressure measurement: increased (High) increased. In 2021, Computerised tomogram: abnormal (abnormal) negative for cancer; sugar spots found on her lungs 2 years prior were a little bit bigger. In 2021, Echocardiogram: abnormal (abnormal) mitral valve prolapse and aortic stenosis. In 2021, Oxygen saturation: 96% (normal) after walk laps over 6 minutes ( 95-97%). In 2021, Pulmonary function test: abnormal (abnormal) showed mild COPD. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient stated that her primary care physician put her on Prednisone 40mg daily for 5 days. She stated that she was more comfortable, but it did not help her breathing. Patient was seen by a Pulmonologist on 9Jun2021. She stated that she smoked for 40 years, so the pulmonologist wanted to do a CT scan to rule out lung cancer and none was found. He did find that the "sugar spot on her lungs," which was found 2 years prior, and was a little bigger but not concerning to him. He took her oxygen level (96) and then had her walk laps around his office for 6 minutes. Her oxygen level then ranged between 95-97%, so she did not need to be on supplemental oxygen. He then did an echocardiogram and diagnosed her with mitral valve prolapse and aortic stenosis. The patient stated that her blood pressure is now high and she is seeing a cardiologist on 19-Jul-2021. She stated that she thinks the vaccine accelerated these things and she's been in a living hell for 3 months. She stated that she used to only have to use her albuterol inhaler 3 or 4 times a year. She said that she pants just sitting in chair and has trouble chopping vegetables. Physician did a Covid test, CBC, PFT, Liver Ultrasound, and tested the patient's liver functions. The patient reported having never been diagnosed with Mitral Valve Prolapse or Aortic Stenosis before the vaccines. She was diagnosed on June 9, 2021 as a result of her Echocardiogram, but she had been feeling effects as of March 22,2021. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's multiple history could be possible confounding factors. This case was linked to SE-MODERNATX, INC.-MOD-2021-104539 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Correspondence email attached. AE outcome updated. Medical and allergy history updated. Further laboratory investigations updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's multiple history could be possible confounding factors.
69 2021-07-17 heart attack hospitalized for NSTEMI
69 2021-07-17 transient ischaemic attack, hypertension mini stroke; high blood pressure; difficulty recalling word; dizziness; no control over body; Shakin... Read more
mini stroke; high blood pressure; difficulty recalling word; dizziness; no control over body; Shaking Arms; weakness; right side jaw pain; soreness; exhaustion; throbbing; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021. The most recent information was received on 12-Jul-2021 and was forwarded to Moderna on 12-Jul-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (mini stroke) and HYPERTENSION (high blood pressure) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016ZMOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion medically significant), MEMORY IMPAIRMENT (difficulty recalling word), DIZZINESS (dizziness), DYSKINESIA (no control over body), TREMOR (Shaking Arms), ASTHENIA (weakness), PAIN IN JAW (right side jaw pain), PAIN (soreness), FATIGUE (exhaustion) and HEADACHE (throbbing). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (mini stroke) (seriousness criterion medically significant). The patient was treated with ALPRAZOLAM (XANAX) at a dose of UNK, qd. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (mini stroke), HYPERTENSION (high blood pressure), MEMORY IMPAIRMENT (difficulty recalling word), DIZZINESS (dizziness), DYSKINESIA (no control over body), TREMOR (Shaking Arms), ASTHENIA (weakness), PAIN IN JAW (right side jaw pain), PAIN (soreness), FATIGUE (exhaustion) and HEADACHE (throbbing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication detail was reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: follow up received and Updated reporter contact information. On 01-Jul-2021: The follow up document contain no new information. On 12-Jul-2021: Added newserious event (transient ischaemic attack).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
69 2021-07-19 blood pressure increased, fast heart rate Extreme pain swelling of left knee joint and minor swelling and pain of right knee joint. Unable to... Read more
Extreme pain swelling of left knee joint and minor swelling and pain of right knee joint. Unable to bend the left knee to a kneeling position or a sitting position. Treated with Ice Pack and rest, MSM cream, Knee brace for approximately 3 days with zero to minimal relief. course of inflamation and pain continues today as of 7/20/2021 no relief and worsening pain in the knee joints migration to hip joints. Have used Volteren 4 times a day (knees) for 7 days no noticeable relief, have used Timed release Tylenol with no relief. Condition has not improved since onset 3/24/2021. Secondarily I have been experiencing increased Blood Pressure readings and Tachycardia (none prior to vaccine)
69 2021-07-22 fibrin d dimer increased May 11, 2021 SOB began at am upon waking. May 13th doctor was contacted and a chest x-ray and blood ... Read more
May 11, 2021 SOB began at am upon waking. May 13th doctor was contacted and a chest x-ray and blood draw was obtained. Results of the D-dimer were elevated and the doctor ordered a CT scan for the morning of May 14th, 1 hour later doctor called and wanted patient to go to ER as a large blood clot was noted on the CT in the pulmonary artery. Patient went to ER and started IV Heparin and was sent to Hospital for admit over night there obtained and ECHO and more blood work which was inconclusive in determining why she got the clot.
69 2021-07-25 blood pressure increased, hypotension Around the beginning of April my blood pressure started to go up. I contacted my cardiologist, and s... Read more
Around the beginning of April my blood pressure started to go up. I contacted my cardiologist, and she prescribed a new blood pressure medicine. The new blood pressure she prescribed was making my blood pressure too low. I cut it in half and stopped taking on 06/02/2021. I contact my PCP and she prescribed me another medication. I am unsure if this has anything to do with my shot, but the timing has me question it.
69 2021-07-27 palpitations 2 days after the vaccination, I experienced extreme fatigue and heart palpitations. After 2 days in... Read more
2 days after the vaccination, I experienced extreme fatigue and heart palpitations. After 2 days in bed, I experienced impaired balance, poor coordination, and migrating pains in my legs. I had some difficulty with hearing and reading. The extreme fatigue and heart palpitations lasted 2 days. The loss of balance and coordination, visual and hearing problems began to diminish slowly after 4 weeks. During this time, I felt that my entire nervous system was slowed down. When I stood, I had to pause and wait for a sense of balance. When reading, I read each word individually and felt that I was waiting for recognition of each word. These problems have improved slowly over the past 2 months. I have some lingering fatigue and irritability.
69 2021-07-28 hypertension, chest discomfort, skin turning blue Pt took BP after 15 observation period and BP was high 147. Did not inform staff, drove home and whe... Read more
Pt took BP after 15 observation period and BP was high 147. Did not inform staff, drove home and when arrived husband noticed her lips were blue and she also had chest tightness some time after. Patient did not seek medical attention and did not consult the pharmacy reported during 2nd shot consultation.
69 2021-07-28 loss of consciousness, cardiac arrest 04/21/2021- First thing in the morning, walked to the bathroom, a few feet from bed, and passed out,... Read more
04/21/2021- First thing in the morning, walked to the bathroom, a few feet from bed, and passed out, hitting my head, lips cut, head cut, bruises on the side of my face, not sure what I hit when I landed. I did not call 911, I called for help and went downstairs and stayed downstairs for 3 days, I had fatigue and pain from injuries, I remained in a state of lethargy and pain for a week following this event. I let my Doctor know the day after I passed out 04/22/2021. May 9th, 2021, I passed out again and went to ER. May 11th, went to doctor she told me to have someone with me all the time . May 12th, 2021 I went into hospital at 10:00AM and I was hospitalized for observance until May 14th, 2021. My heart was stopping for a few seconds and then on May 14th, 2021, it stopped for 21 seconds. On Friday May 14th, 2021 they put a pace maker in me but I had no prior heart issues. I was released on May 15th, 2021. I have had 5 different appointments including a stress test since the pace maker implant. On Friday July 23rd, 2021 I had thyroid lab work and it is finally starting to stabilize.
70 2021-01-05 chest pain Began to develop rash on neck and front chest on 12/31/2020; progressive got worse and spread to upp... Read more
Began to develop rash on neck and front chest on 12/31/2020; progressive got worse and spread to upper arms on 1/3/2021. Rash continues and on 1/5/22021 spread to lower ext extremities. Taking Benadryl 50 Mg at night and Allegra 180 during the day to manage the rash. Mild chest pain on the left upper chest; cannot differentiate if it was a muscular pain or actual chest pain.
70 2021-01-06 heart rate increased, hypertension HIGH BP AND PULSE BETWEEN 9:30 PM AND MIDNIGHT THE EVENING AFTER THE VACCINE: 175/99 PULSE 149, 1... Read more
HIGH BP AND PULSE BETWEEN 9:30 PM AND MIDNIGHT THE EVENING AFTER THE VACCINE: 175/99 PULSE 149, 151/79 PULSE 115, 154/73 PULSE 139, 163/77 PULSE 137.
70 2021-01-07 chest discomfort Dizziness, throat and lung discomfort, swelling.
70 2021-01-07 chest pain Patient reported symptoms of chest pain, headache and dizziness. EKG, continuous telemetry, oxygen ... Read more
Patient reported symptoms of chest pain, headache and dizziness. EKG, continuous telemetry, oxygen and labs were done. Chest pain lessened, headache remained the same and patient was given Tylenol. MD felt headache was probably r/t pre existing osteopathic changes in her neck and shoulder. Patient received meclizine and acetaminophen.
70 2021-01-07 chest pain Shortness of breath ,chest and stomach pain, fatigue very weak,headache, aches,vomiting, diarrhea. V... Read more
Shortness of breath ,chest and stomach pain, fatigue very weak,headache, aches,vomiting, diarrhea. Vomiting and diarrhea started 2 days after vaccine. All others started 12 hours after vaccine except injection site 2 hours after injection. Still weak.
70 2021-01-07 chest pain Very tired, arm pain, burning in chest, stinging down arm, became a deep ache. fever 100.2.
70 2021-01-07 loss of consciousness, blood glucose increased Allergic reaction / Syncope and collapse Patient reports feeling dizzy, hot, and that her eyes fel... Read more
Allergic reaction / Syncope and collapse Patient reports feeling dizzy, hot, and that her eyes felt funny. Patient was sweaty, heart rate within normal rhythm . Patient lost consciousness and began seizure-like activity and was assisted to the ground. Patient regained consciousness about 20 seconds later. At 12:48: BP was 91/44 upper right arm, HR 78, O2 sat 100%. At 12:50 BP was 76/50 and patient report shortness of breath and the sensation that her throat was closing up. She was assisted to supine position again. at 12:54 Epinephrine 0.3ml was administered IM. At 12:56 NS administered wide open with pressure. Blood glucose 109. at 12:59 BP was 133/67. Taken to Emergency Department where she received famotidin 20mg IV, Methylprednisolone 80mg IV and KCL 20mEq po due to Potassium level of 3.4.
70 2021-01-08 blood pressure increased On 9th day following vaccination, I developed swelling, redness, itching and induration at the injec... Read more
On 9th day following vaccination, I developed swelling, redness, itching and induration at the injection site. Also experiencing headache and spike in blood pressure, not sure whether related or not.
70 2021-01-11 blood pressure increased PT COMPLAINED OF NUMBNESS IN HER ARM AND COMPARED TO THE SENSATION TO BEING SIMILAR TO FEELING SHE H... Read more
PT COMPLAINED OF NUMBNESS IN HER ARM AND COMPARED TO THE SENSATION TO BEING SIMILAR TO FEELING SHE HAD EXPERIENCED WHEN HAVING A SEIZURE. TAKEN TO ER, NO SEIZURE. ELEVATED B/P 210/90
70 2021-01-11 fast heart rate, hypertension Minutes after administration face red, arms, and legs -- red all over body, very hot all over, high ... Read more
Minutes after administration face red, arms, and legs -- red all over body, very hot all over, high blood pressure, tachycardia heart, throat closing. Medication given immediately after reaction in Medical Clinic. Medication given is unknown to pt. Pt was then taken to hospital ER Hospital but left afterwards with ER full with patients to be attended. Pt had nausea and heat in stomach for days after keep liquid diet, fatigue; steroids allergy medication prescribed taking daily.
70 2021-01-14 lightheadedness, hypertension, fast heart rate hypertensive/tachycardic (possible vasovagal reaction) persisted > 1 hour post-dose and requiring an... Read more
hypertensive/tachycardic (possible vasovagal reaction) persisted > 1 hour post-dose and requiring antihypertensive medication be administered
70 2021-01-17 palpitations Starting Saturday the 9th started to feel a pulsing sensation all through her body, on Sunday right ... Read more
Starting Saturday the 9th started to feel a pulsing sensation all through her body, on Sunday right arm close to her wrist could feel a strong palpitation this happened twice, 3 times since vaccination once three hours ago her jaw moved on its own. Reached out to pharmacy who referred her to VAERS, and did try to her doctor office today but they were closed and she did not want to leave a message.
70 2021-01-19 heart rate irregular 36 hours after vaccination - rapid irregular heartbeat of 160 lasting for several hours
70 2021-01-19 loss of consciousness, cerebral haemorrhage Patient received her first dose of the Moderna COVID-19 Vaccination on Saturday January 16th 2021 at... Read more
Patient received her first dose of the Moderna COVID-19 Vaccination on Saturday January 16th 2021 at approximately 12pm. She completed all necessary screening forms and was deemed to be at low risk for serious allergic reactions. She tolerated the vaccination well, and no complications or immediate adverse events occurred. She was observed for a full 15 mins per CDPHE/CDC guidelines and left the Clinic in stable condition after her observation period was complete. On the morning of Tuesday, January 19th, 2021, the patient was found unconscious and unresponsive by her husband. She was transferred by Ambulance to Hospital shortly thereafter. She was diagnosed with a brain bleed that was determined to be inoperable. She was transferred to other Hospital for higher level care. She was seen by neurosurgery and diagnosed with a ruptured aneurysm. She was treated in the ICU for 24 hours, at which point her team determined that the severity of her brain bleed would not respond to treatment. Supportive cares were withdrawn on Wednesday Jan 20th, and she passed away shortly thereafter.
70 2021-01-20 heart rate increased Restlessness, headache, swollen left cheek, elevated heart rate.
70 2021-01-23 heart rate increased Extreme thirst Very sleepy Fast heart rate Chills Rash and itchy at injection site
70 2021-01-24 blood pressure increased, heart rate increased On 1/24 about half hour after shot had a medal taste in my mouth. Around 3:00 pm I had numbness arou... Read more
On 1/24 about half hour after shot had a medal taste in my mouth. Around 3:00 pm I had numbness around my face and left ear. My heart rate was elevated and elevated blood pressure. Went to the ER and checked to make sure I was not having a stoke. Today 1/25/2021, I feel drained and groggy but the numbness has gone.
70 2021-01-24 chest pain Today woke up with raised area at injection site, about 1/2 dollar size, increased redness, increas... Read more
Today woke up with raised area at injection site, about 1/2 dollar size, increased redness, increased warmth, itchy. Tender to touch. She also reported fatigue, chest pain since yesterday with activity intolerance. Noted irregular heart rate on my initial exam, converted to sinus by the time EKG was done.
70 2021-01-24 cardiac arrhythmia, fast heart rate, heart rate abnormal PVC and tachycardia on ECG occurring within 30 minutes post injection. Metoprolol succinate ER 25 mg... Read more
PVC and tachycardia on ECG occurring within 30 minutes post injection. Metoprolol succinate ER 25 mg prescribed. Patient remained 96-99% O2 with HR 100-106. Patient discharged home in stable condition.
70 2021-01-25 hypertension 10 minutes after vaccine, dizziness, sweating, blood pressure was extremely high, mind fogginess, sh... Read more
10 minutes after vaccine, dizziness, sweating, blood pressure was extremely high, mind fogginess, shaky
70 2021-01-27 fainting 28 hours post vaccine : fever of 101.2, headache,chills,fainting,nausea, arm sore,red. Systemic sym... Read more
28 hours post vaccine : fever of 101.2, headache,chills,fainting,nausea, arm sore,red. Systemic symptoms lasted 40 hours and resolved. Arm continued to swell and a hard, hot red lump developed. Redness expanded to cover entire upper arm. A hive like rash developed day 2-3 and lasted for 3 days. Day 7 I contacted my physician and was told he doesn?t deal with COVID and vaccine issues. Day 15-16 swelling and redness mostly resolved. Day 21 arm is still sore.
70 2021-01-27 fast heart rate, hypertension Developed tachycardia and elevation in blood pressure after receiving vaccination. Next day experien... Read more
Developed tachycardia and elevation in blood pressure after receiving vaccination. Next day experienced headache. Seen by PCP who advised she not receive the 2nd vaccine.
70 2021-01-28 blood pressure increased Elevated blood pressure, headache, spreading rash and welling and rash at injection site
70 2021-01-28 heart rate irregular, palpitations On Jan 18 ,2021 I experienced severe anxiety and heart palpitations that have continued on and off s... Read more
On Jan 18 ,2021 I experienced severe anxiety and heart palpitations that have continued on and off since that date. Heart rate varies from 35-120 and I can feel the palpitations .
70 2021-01-28 hypertension, chest discomfort, heart rate increased Nocturnal chest tightness, rapid thready pulse, high blood pressure, fatigue and weakness. Symptoms ... Read more
Nocturnal chest tightness, rapid thready pulse, high blood pressure, fatigue and weakness. Symptoms began about 1:30 AM often on until 4 AM. Following day experienced mild fever and flu like symptoms.
70 2021-01-28 lightheadedness pt was vaccinated with no reported issues. pt waited required 15 minutes in pharmacy area with no r... Read more
pt was vaccinated with no reported issues. pt waited required 15 minutes in pharmacy area with no reported issues. when pt sat up from chair and began walking to care they experienced the following: tremors, flushing, sweating, near fainting like symptoms, muscle weakness. symptoms lasted approximately 5-10 minutes and were resolved completely after given cold water and after sitting for an extra 15 minutes.
70 2021-01-29 chest pain Stomach pains like a knife being stuck in. chest pain couldn't breath, weak, 2 days later vomited, C... Read more
Stomach pains like a knife being stuck in. chest pain couldn't breath, weak, 2 days later vomited, Confusion. Felt better after a week.
70 2021-01-30 chest pain Asthma, trouble breathing, chest pain, arm pain (both arms), headache, flu-like symptoms, congestion... Read more
Asthma, trouble breathing, chest pain, arm pain (both arms), headache, flu-like symptoms, congestion for a few days following dose
70 2021-02-01 chest discomfort After receiving the injection, I was directed by an RN to sit in a chair for 15min in the same room.... Read more
After receiving the injection, I was directed by an RN to sit in a chair for 15min in the same room. Five minutes after the injection I felt my upper back muscles, ribcage area, contract. The contraction continued around to the front of my chest with next 3 minutes. I felt tightness with each breath. The RN who gave me the injection came to see if I felt alright. She informed the charge nurse that my chest felt tight and the charge nurse came to ask me questions. The charge nurse called the hospital pharmacist to come to see me. The pharmacist arrived with various medications and talked to me. He instructed me to do breathing exercises and meditate. I told him that I was familiar with these techniques and using them. I also informed the pharmacist that I had a heart attack in 2018 and had atrial tachycardia but I wasn't feeling any problems with my heart, that it was beating normally. I also informed the pharmacist of my severe allergies to certain items but I wasn't experiencing any anaphylaxis that I've experienced in past allergic episodes. The pharmacist left and told the charge nurse to keep me a half hour longer under observation and to call him if I felt worse. During that half hour, the muscle contractions stopped and I was able to breathe normally. The charge nurse asked me if I was ready to leave after the half hour was up, I told her I was feeling odd so she said to stay another 20min. I began to experience intestinal cramping and asked to leave to go to the bathroom. In the bathroom I had a bout of diarreah that lasted 10minutes. After that I drove home but was experiencing a headache that started. The headache lasted for 20hrs. It felt like I was wearing tight hat, squeezing. Iv'e not had that type of headache before. My right arm site of injection feels a little warm and is pink but isn't painful.
70 2021-02-01 ventricular tachycardia 2ND ACHY. DAY AFTER INJECTION. RAN FEVER 101.6. BECAME CONFUSED. GROUND GLASS COUGH, VENTRICULAR TAC... Read more
2ND ACHY. DAY AFTER INJECTION. RAN FEVER 101.6. BECAME CONFUSED. GROUND GLASS COUGH, VENTRICULAR TACHYCARDIA. ADMITTED TO HOSPITAL. IV STEROIDS,AND ANTIBIOTIC STARTED. CHANGED TO PO AFTER 3 DAYS. PT IMPROVED. COUGH RESOLVED PT SENT HOME WITH ORAL STEROIDS AND ANTIBIOTICS FOR 3 DAYS.
70 2021-02-03 palpitations, fast heart rate, hypotension Immediate shooting pains in head. Within 3 hours had headache & fatigue. 6 hours post vaccination hy... Read more
Immediate shooting pains in head. Within 3 hours had headache & fatigue. 6 hours post vaccination hypotension and tachycardia, increasing over next 4 hours. Resulted in heart palpitations. BP 80/53. HR 122. Considered going to ER. 13 hours post-vaccination normal BP and HR. Day 2 BP and HR normal. Day 3 BP very high 162/89, HR normal. Day 4 BP and HR normal, no headache, no fatigue. Normal since. Been taking BP/HR daily for last 3 months. Normal for me is 135/75 BP, 80 HR. Have not had heart palpitations in very long time prior to this vaccination. Contacted doctor and was strongly advised not to get second dose of Moderna due to probable allergic reaction. No other allergic symptoms to the vaccination.
70 2021-02-07 palpitations Palpitations with heart rate over 160- 1st episode on 2/5/21 within 5 minutes of receiving vaccine. ... Read more
Palpitations with heart rate over 160- 1st episode on 2/5/21 within 5 minutes of receiving vaccine. Transferred to Urgent care for monitoring and EKG. EKG reported as normal. Reports she had a couple more heart racing episodes while sleeping overnight Friday 2/5 into Saturday morning; each episode lasted less than 2 minutes and not to the extent of episode on 2/5/21.
70 2021-02-07 lightheadedness Dizzy - BP 114/85 (pulse 68); improved with water. MD speculated vasovagal reaction.
70 2021-02-08 chest pain, chest discomfort 70 YO F WHO JUST RECIEVED HER FIRST DOSE OF THE COVID VACCINE PRESENTED TO THE OBSERVATION AREA STAT... Read more
70 YO F WHO JUST RECIEVED HER FIRST DOSE OF THE COVID VACCINE PRESENTED TO THE OBSERVATION AREA STATING THAT IMMEDIATELY ON RECIEVING THE SHOT SHE DEVELOPED RIGHT SIDED FACIAL NUMBNESS, AN ACHY CHEST PAIN IN CENTER OF HER CHEST THAT IS COVERED BY 3 FINGER TIPS, AND A SENSATION IN HER ABDOMEN THAT IT WAS BECOMING ENGORGED WITH FLUID. PT STATES THAT BREATHING MAKES HER CHEST DISCOMFORT WORSE BUT PALPATION MAKES IT BETTER. HAS NEVER FELT THIS WAY BEFORE. PT ALSO HAS AN EXTENSIVE LIST OF MEDICATION ALLERGIES WITH PRESENTATIONS FROM CHEST PAIN, SOB, HA, NAUSEA, ITCHING, AND FATIGUE. FOUND PT SITTING IN HER CAR A/O X4 IN NO OBV DISTRESS. HEENT - PERRL, NO JVD, NO FACIAL DROOP, = SMILE. CHEST - LS = CLEAR BILAT, EKG SR WITHOUT ECTOPY, 12 LEAD NSR WITHOUT ECTOPY, NORM ST SEGMENTS, NO BLOCKS AND APPEARS TO BE A NONISCHEMIC EKG. EXTREM - PWD, GOOD PMS X4, MOVES ALL WITH PURPOSE. EXAM, VS, O2 SAT, EKG, 12 LEAD, BASE, Pt transported to ED
70 2021-02-08 hypertension HTN approx 30 min post injection 195-220 systolic. C/o HA, dizziness. Tx to ED for further managemen... Read more
HTN approx 30 min post injection 195-220 systolic. C/o HA, dizziness. Tx to ED for further management where pt received clonidine.
70 2021-02-08 palpitations patient complain of having a racing heart
70 2021-02-10 blood pressure increased unusually high blood pressure was the main problem 177/99 slight headache slightly sore arm (not ba... Read more
unusually high blood pressure was the main problem 177/99 slight headache slightly sore arm (not bad) general crappy feeling
70 2021-02-10 heart rate increased Patient stated her heart was running away. Nurse checked her heart rate 90/min & regular. Medic ar... Read more
Patient stated her heart was running away. Nurse checked her heart rate 90/min & regular. Medic arrived and checked client's B/P 140/104. Client denied SOB. No facial swelling noted. 911 called & arrived and checked client out. B/P 147/90. Cardiac monitor applied by ambulance staff. HR was regular. Client was released home per ambulance staff. Instructed to call 911 if s/s returns and et her PCP know if reaction occur. Will contact is her PCP.
70 2021-02-11 pallor, palpitations Almost immediately after receiving the shot, my heart started racing . we called for help and the em... Read more
Almost immediately after receiving the shot, my heart started racing . we called for help and the emt's on site took my bp. It was 184/125 and my heart rate was through the roof. I think it was around 135. I was pale and felt funny! After around 15 minutes I felt better. My heart rate and bp started coming down but the emt's advised me to go by ambulance to the ER and be checked out. I was fine once I got to the ER. they did a 12 lead EKG and I waited three hours to see a doctor who discharged me and advised against getting the second dose of the vaccine.
70 2021-02-11 fast heart rate Pt administered 2nd dose COVID-19 vaccine this morning at 0937. Similar to reaction from 1st dose, s... Read more
Pt administered 2nd dose COVID-19 vaccine this morning at 0937. Similar to reaction from 1st dose, she reported feeling tachycardic and was placed on automatic BP monitor. BP initially 200/115 with HR 135. At 1005 she was given metoprolol tartrate 25mg PO x1. Within a short amount of time BP and HR began to come down and Pt appeared calm and conversational. BP came down to 159/98, HR 104. Pt reported feeling better and decided to leave at 1029.
70 2021-02-12 blood pressure increased As of 2/12/21 my symptoms are fever of 101.3, no appetite, weakness, fatigue, body ache, arm ache, c... Read more
As of 2/12/21 my symptoms are fever of 101.3, no appetite, weakness, fatigue, body ache, arm ache, cold sweats, sweat running down my face, my chest, my arms, strong chills, I shook uncontrollable , (I no longer have chills now 2/13/21) my blood pressure went up 2/13/21 to 135/85. Headache
70 2021-02-13 chest discomfort Pt stated ?feels like my tongue has doubled in size ? difficulty swallowing and chest tightness
70 2021-02-13 palpitations I first became exhausted 4 hours after the shot and my arm started to hurt. I had headaches, intermi... Read more
I first became exhausted 4 hours after the shot and my arm started to hurt. I had headaches, intermittent sweating, deep exhaustion and body aches, occasional sharp shooting pains around my body, and a feeling of heaviness and lassitude. My arm remained sore, and these symptoms lasted for 5 days. I stayed in bed. I also took ibuprofen the next day, for the symptoms, not realizing I was not meant to do that. I was already weary, and dealing with major stress for weeks before the vaccine. And I had been taking max doses of OTC painkillers for an extracted tooth for over two weeks before the shot. The tooth extraction had problems but because of Covid risk my dentist told me to "tough it out." I took 800mg of ibuprofen and 1000 of Tylenol every six hours for over two weeks.
70 2021-02-14 body temperature decreased, blood pressure increased Day 2 sore arm, body aches, 99.8 temp, by evening large red spot around injection site Day 3 swing f... Read more
Day 2 sore arm, body aches, 99.8 temp, by evening large red spot around injection site Day 3 swing from chills to fever, red spot enlarges, is swollen and hot, tylenol helps temp down to 99.7 Days 3 - 7 arm gets hotter, stays swollen, hot and very red from above elbow to almost top of arm. Slowly dissipates. Blood Pressure spiked one day to 162/105 and saw doctor about that.
70 2021-02-14 chest discomfort Patient has a history of drug sensitivity to oral penicillin with a rash that developed greater than... Read more
Patient has a history of drug sensitivity to oral penicillin with a rash that developed greater than 4 hours after ingestion. The patient was administered Moderna vaccine Lot 016M20A at 1025 to the right deltoid muscle. At 10:49 the patient complained of facial itching, also stating a headache within minutes of injection. Patient was assessed, BP was 186/92 and HR 72. the patient was alert and oriented without signs of immediate distress. Just prior to administration of epi the patient complained of chest tightness. Patient BP was noted to be 182/94 at 5 minutes post epi. Ambulance arrived 11:05am and the patient was released to the care of EMS.
70 2021-02-14 fainting I had a bad headache on the first day getting the shot and had a mild headache for the few days. on... Read more
I had a bad headache on the first day getting the shot and had a mild headache for the few days. on Feb. 14th I had stomach ache and diarrhea and vomiting, and then I felt dizzy and fainted.
70 2021-02-14 fast heart rate, hypertension Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Syst... Read more
Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Systemic: Other- sob-Medium
70 2021-02-15 chest discomfort Possible minor allergic reaction with itchy eyes, scratchy throat, funny nose, slight chest discomfo... Read more
Possible minor allergic reaction with itchy eyes, scratchy throat, funny nose, slight chest discomfort. Benadryl one dose on Sunday pm and one dose on Monday pm.
70 2021-02-16 chest pain 70 year old patient felt funny after shot. EMS was called vitals were taken BP 174/80 99% O2 room a... Read more
70 year old patient felt funny after shot. EMS was called vitals were taken BP 174/80 99% O2 room air HR 78. Chest Pain, Non-Cardiac but patient refused additional evaluation and care. Released against medical advice.
70 2021-02-16 fast heart rate one episode of tachycardia. HR of 150 lasting 3-4 hours.
70 2021-02-17 chest discomfort, heart rate increased Approximately 12:30 PM on 2-12-21, about 1 hour 30 minutes after vaccination, I experienced severe d... Read more
Approximately 12:30 PM on 2-12-21, about 1 hour 30 minutes after vaccination, I experienced severe diarrhea. At about 1;30 PM on 2-12-21 I became severely dizzy, very high heart rate (115-120- heart rate was irregular), nauseated and experienced chest tightness. Moderate shortness of breath. I was unable to walk unassisted due to dizziness. This lasted about 3 hours. When I awoke on 2-13-12 the dizziness and shortness of breath was gone. I experienced mild flu-like symptoms on 2-13-21 (general achiness, tiredness, slight fever - 99degrees- mild headache). Symptoms were treated with Tylenol and had subsided by 2-14-12.
70 2021-02-17 chest pain Shortness of breath, chest pain, belching, nausea, and very tired.
70 2021-02-17 loss of consciousness Patient passed out for a couple of minutes. She was moved to a couch and her feet propped up. Afte... Read more
Patient passed out for a couple of minutes. She was moved to a couch and her feet propped up. After 30 minutes, she was doing well.
70 2021-02-18 hypertension Severe headache, body aches, elevated blood pressure, sweats, weakness x48 hrs. followed by fatigue,... Read more
Severe headache, body aches, elevated blood pressure, sweats, weakness x48 hrs. followed by fatigue, intermittent HA, and joint pain, ear pain, lack of appetite, cough x5days total
70 2021-02-18 palpitations, blood pressure decreased anaphylactic shock 30 minutes after receiving shot with tongue swelling, air passage swollen shut, ... Read more
anaphylactic shock 30 minutes after receiving shot with tongue swelling, air passage swollen shut, and unable to breathe. received 2 epi pens shots and large shot of Benadryl from paramedics. I am still having AFTER EFFECTS 1 week later. Heart still races and blood pressure drops.
70 2021-02-19 blood glucose increased, heart rate increased Fasting Blood sugar - 141 on 2/15 - 6 AM. Fasting Blood sugar - 124 on 2/16 - 6AM, 2/20 - Blood su... Read more
Fasting Blood sugar - 141 on 2/15 - 6 AM. Fasting Blood sugar - 124 on 2/16 - 6AM, 2/20 - Blood sugar - 183, 2 hours after eating. 2/15 - Fever 100.1 and agitation all day and high pulse all day
70 2021-02-19 pallor 20 MINUTES AFTER RECIEVING The COVID VACCINE, THE PATIENT Became PALE, & NAUSEOUS BP 84/57 P 64 Pul... Read more
20 MINUTES AFTER RECIEVING The COVID VACCINE, THE PATIENT Became PALE, & NAUSEOUS BP 84/57 P 64 Pulse oxcimitry 99%- Rest FLUIDS & & SNACK The PATIENT improved BP 93/65 &was DISCHARGED
70 2021-02-21 blood glucose increased I had no reaction after the first dose. However about 24 hours after the second dose my blood glucos... Read more
I had no reaction after the first dose. However about 24 hours after the second dose my blood glucose levels remained elevated for about 48 hours, regardless of how much insulin I administered both via my pump (increasing basal and bolus rates) and MDI. The levels remained in the mid to upper 200s. With an average A1c in the high 5s and low 6s, this was unusual for me.
70 2021-02-21 heart rate increased, blood pressure increased no initial reactions, slight soreness 3 days. 9 days later had increased joint pain. Woke up 10th da... Read more
no initial reactions, slight soreness 3 days. 9 days later had increased joint pain. Woke up 10th day with blotches on injection sight. As day progressed felt discomfort, site began to get itchy. In evening checked and blotches became one mass, swollen, very warm to touch. Called pharmacy, they never heard of delayed reaction said take benedryl and call primary dr in morning. Went to pharmacy, the pharmacist looked at it and felt it, also never saw delayed reaction, gave same instructions. Sent picture to primary, did video call today, 99.7 temp, elevated BP and pulse. She saw picture, close up on screen, concerned one spot darker might be cellulitis, need to watch, take benedryl, call if changes, report to CDC
70 2021-02-21 heart rate increased, chest pain, pulse abnormal Approximately 14 hours after receiving the vaccine, I woke up at 2:15 a.m. feeling pains in my chest... Read more
Approximately 14 hours after receiving the vaccine, I woke up at 2:15 a.m. feeling pains in my chest middle and extending through to my upper back. The pain encompassed the span of my upper chest and back from one arm to the other. I experienced very rapid heartbeats that I could feel throbbing from my head to my chest. I was hesitant to move or rise from my bed because of the pain. At 3:40 I called 911. They did an EKG and I was told that my heart was fine. My blood pressure was 180/90. I chose not to go to the hospital but to call my doctor when his office opened up at 9:00 a.m. in approximately 5 hours. My doctor had me come into his office. I had another EKG which was fine and he sent me to have a Cat Scan. the same day which was also fine. My doctor spoke to me and said that he felt that this was due to side effects of the vaccine. I doubled up on my Acid Reflux medicine, taking 80 mg daily for four days through Monday 2/22/2021. I could not sleep well for three days after the vaccine experiencing pain in my chest and could not breathe deeply without feeling it. Then I steadily improved and today I can take deep breaths with little pain. I also experienced muscle pain in my left shoulder and neck but used Mineral Ice on my neck and was relieved in one day.
70 2021-02-21 hypertension One side effect I still have, I now have very high blood pressure. I?ve been to my cardiologist, w... Read more
One side effect I still have, I now have very high blood pressure. I?ve been to my cardiologist, wore a heart monitor for 5 days, follow up appointment in 2 weeks. I?ve quadrupled my BP dosage, blood pressure is still high.
70 2021-02-22 haemoglobin decreased symptoms since her dose of Covid Moderna vaccine on Jan the 25th. In the first 1-2 days she had the... Read more
symptoms since her dose of Covid Moderna vaccine on Jan the 25th. In the first 1-2 days she had the usual soreness at the injection site but nothing else. Then, about a week after it, her arm in the area of the injection site gradually became red and warm and indurated slightly without pain About the same time she noted a sense of fatigue and feverishness. Her temp was 100.4 or thereabouts. This persisted for a couple of days with no fever in the morning or midday but feverishness in the late afternoon /early evening and the temp always between 100.2 100.4. The redness of the upper arm increased to an area of about 2x3 inches. On Feb 2nd or 3rd she began a ten day course of penicillin 500mg qid x 24 hr then 250 mg qid x 9 days. The redness, induration and warmth improved and returned to normal gradually over the next 5 days or so. She stopped the penicillin on Feb 12th. Her temperatures in the late afternoons during the time of taking the penicillin were mostly between 100 and 100.4 and in the final couple of days of taking the penicillin it seemed to be resolving. The day after the penicillin it was 99. However, on the 15th it was 101. and since then it has been about 100.4 Her arm still appears normal . Other symptoms she is complaining of bilateral lateral hip pain. She feels quite achy. She believes this started since the vaccine dose I believe she may have had some complaints prior to it. No joint complaints, no upper extremity symptoms other than as above. No HA, ST. She has had what she describes as "spasms in her chest") which has improved but presented about the same time as the arm and temperature did. No Gi symptoms. Her activity has not been curtailed. Neck pain bilat was noted starting the end of December without other symptoms and wo any hx of trauma and did not feel like a typical wry neck. No travel other than for the vaccine, to the grocery store and rarely to another shop. No exposures to anyone other than our grandchildren, son and dau-in-law who are in our "bubble" (the granddaughter attends an out door preschool where they all wear masks and have had no covid cases.Patient walks weekly out doors with a friend. She sees her mother who at 96 resides at home and sees no one. She had a NP swab for Covid PCR test yesterday (the 17th) which is reported this am as "undetected". An evaluation with Doctor led to blood work showing wbc 9.2, hgb 11, plt 546k, ESR 74, CRP 67 a diagnosis of PMR was tentatively made and she was started on prednisone 15 mg /d. Improvement was seen at 24 hours and persisted. Neck pain is 80% better as well. Questions: Did the vaccine play a role in exacerbating a preceeding condition of PMR? If the neck pain is a red herring, did the vaccine cause PMR?
70 2021-02-23 heart rate increased Around 5:30 PM, I had to stop putting up groceries, get into lounging clothes, and put a box fan on ... Read more
Around 5:30 PM, I had to stop putting up groceries, get into lounging clothes, and put a box fan on me while lying down. I experience shortness of breath, rapid heartbeat, dizziness, and weakness. My left upper quadrant is sore from the Moderna vaccine. It appears to be spreading circular to the size of a quarter to about the size of a fifty-cent piece. I had gone to sleep. I contacted the veteran 24 hour nurse, my best friend, and my brother to tell them my health status. I had eaten dinner, taken a Tylenol, and went back to sleep before brushing my teeth.
70 2021-02-24 blood pressure increased, pallor Shortness of breath, Uncontrolled shaking, elevated BP, Pale, Clammy, eyes rolled back in head,
70 2021-02-24 fainting PT WAS GIVEN VACCINEE. WITHIN 3 TO 5 MINUTES, SHE APPEARED TO BE HAVING A SEIZURE. AID WAS ADMINISTE... Read more
PT WAS GIVEN VACCINEE. WITHIN 3 TO 5 MINUTES, SHE APPEARED TO BE HAVING A SEIZURE. AID WAS ADMINISTERED. RPH HELD HER UPRIGHT (PT WAS FALLING OUT OF HER SCOOTER). 911 WAS CALLED AND ICE PACK APPLIED TO CHEST TO HELP WITH FIGHT OR FLIGHT FEELING. SHE WAS NAUSEOUS, LIGHT-HEADED, AND FAINTED. PT WAS HELD UNTIL EMT'S ARRIVE, AT WHICH POITN SHE WAS COHERENT. STAFF AT FACILITY BROUGHT THE PATIENT ORANGE JUICE. SHE WAS OK WITH SITTING AND STANDING BP O F96/62. SHE FELT BETTER AND REFUSED TO GO TO THE HOSPITAL.
70 2021-02-25 chest discomfort Patient complained of chest tightness, Shortness of breath, nausea, dizziness.
70 2021-02-25 chest discomfort Stiff neck, headache, joint and muscle aches. Some tightness in chest and mild cough. Treated with ... Read more
Stiff neck, headache, joint and muscle aches. Some tightness in chest and mild cough. Treated with Tylenol.
70 2021-02-25 chest discomfort Tightening chest, uncontrollable cough, short of breath, sweating, tingling lips and throat, shaking
70 2021-02-25 nosebleed Headache, fatigue, extreme exhaustion, chills, vomiting, body aches, nausea, excessive sleeping, los... Read more
Headache, fatigue, extreme exhaustion, chills, vomiting, body aches, nausea, excessive sleeping, loss of appetite, nose bleeding 24 Hours
70 2021-02-25 heart rate increased React occurred 15 hours after receiving the vaccine. Arm swollen red hot. THROAT & FACE SWOLLEN. T... Read more
React occurred 15 hours after receiving the vaccine. Arm swollen red hot. THROAT & FACE SWOLLEN. Throbbing headache Fever. RAPID HEART RATE.
70 2021-02-25 heart rate increased Rapid heart beat for 20 hours. Normal hr 65-75. Rapid equaled 110-120.
70 2021-02-25 hypertension Elevated blood pressure. I have never had blood pressure problems in the past. Doctor advised me to ... Read more
Elevated blood pressure. I have never had blood pressure problems in the past. Doctor advised me to monitor it at home and report if the numbers increase.
70 2021-02-25 pallor, hypotension patient diaphoretic, pale, c/o dizziness and nausea. no LOC, no falls, no vomiting. no other advers... Read more
patient diaphoretic, pale, c/o dizziness and nausea. no LOC, no falls, no vomiting. no other adverse reactions. BP low but stable throughout: 12:07 91/62, O2 sat 98%, P 78. Drank water, apple juice, cold pack applied to neck/forehead. Patient recovered within a few minutes. MD Stat was called. Dr. examined patient. MD in Covid Clinic also examined patient. Patient able to sit in chair during this reaction, and was stable to do orthostatic VS. VS 12:55 pm BP 103/64, O2 sat 96%, P 80. Patient called a family friend, felt well, was stable and ambulated to car and was driven home. last VS prior to leaving Covid clinic at 1:30 were BP 112/62, O2 Sat 97% P 85.
70 2021-02-26 fainting headache, chills, fever, red swollen right arm, nausea, and fainted four times on day two. all sympt... Read more
headache, chills, fever, red swollen right arm, nausea, and fainted four times on day two. all symptoms lasted 5 full days and nights.
70 2021-02-27 fainting Woke up at my usual time the day after vaccine. Felt a little warm but not feverish and did not take... Read more
Woke up at my usual time the day after vaccine. Felt a little warm but not feverish and did not take my temperature. After walking to kitchen to let cat in from garage I stopped at the nearby kitchen sink and began to shake ( I believe just my upper body). I had to grab onto sink to steady myself. Shaking was only seconds long. Then I must have fainted as I awoke (quickly) on the floor alongside the cupboards and sliding glass door. I laid there conscious about 15 minutes till I felt confident I could get up on my own. As result of fall I bit upper and lower lip on right (no blood just skin injured), must have clenched my teeth because my left posterior teeth were sensitive to cold and I injured my right ankle. After I got up and realized my ankle hurt with pressure I put on a support knee high to control swelling. Injury seemed to be focused on the ankle bone. I applied ice for recommended 20 on 20 off protocol for most of both 2/25 and 2/26, elevated and took OTC Aleve as directed on package. Bruising observed from heel, behind ankle bone and front of ankle. Called PCP, she recommended continue as I have and she will contact me tomorrow, March 1
70 2021-02-28 blood pressure increased On 2/252021 at 9:30 am I experienced a very strange sensation spreading across my chest, left to ri... Read more
On 2/252021 at 9:30 am I experienced a very strange sensation spreading across my chest, left to right, my right be partially numb. I checked my blood pressure & it was 199/105, 10 minutes later 197/101. I went to ER arriving at 10 am. Had EKG, blood work, chest xray, covid quick test. All ok. BP stayed very high until 12:30 pm then started to go down. After about an hour bp went back up to 188/99. I was given a pill to lower pressure but it didn't lower. Finally given a dose of metroprolol & pressure went down. Was released from ER at 3:45 pm. Today, 3/1/2021 BP is still high, 166/87. Went to cardiologist 3/1/2021, was told they were having these type issues lately. No problem with EKG, blood work. Gave me another BP pill to try for 2 weeks to try lower BP.
70 2021-02-28 chest discomfort Immunized 70 Y/O female with Moderna vaccine Lot#010A21A. Client instructed to remain in observation... Read more
Immunized 70 Y/O female with Moderna vaccine Lot#010A21A. Client instructed to remain in observation area x 30 min. 11:42 client alert and oriented x 3. Noted to have flushed face & c/o SOB and chest tightening. Client reported she took OTC Benadryl 25MG. Reported allergies to iodine, shellfish, cipro and PCN. Abx caused rash. Current medications included Singular. 11:48 BP 162/110. Client continued to experience SOB and chest tightening. Called 911 & activated EMS. Continued to observe client. 11:56 EMS arrived and completed an assessment. BP 171/97 -87. Client reported she was feeling better. 12:10 Client refused EMS transport. 12:20 client drove home. 3:07 called client for follow up. She stated she felt better but tired and had a HA.
70 2021-02-28 hypotension, heart rate increased Headache after injection- 2/24/21 Lasted for 2 days Headache/ extreme fatigue, neck pain, extreme le... Read more
Headache after injection- 2/24/21 Lasted for 2 days Headache/ extreme fatigue, neck pain, extreme left arm soreness, back pain, 2/25/21 Headache/ fatigue/ body aches - morning of 2/26/21 Rapid heart rate up to 128 bpm sitting still, rapid breathing, tight throat, low blood pressure. These symptoms began afternoon of 2/26/21 and lasted at least 5 hours.
70 2021-02-28 palpitations, blood pressure increased About 6 hours after receiving shot, patient had sore arm that went into the armpit area and by 9 pm... Read more
About 6 hours after receiving shot, patient had sore arm that went into the armpit area and by 9 pm that day she was feeling soreness/pain all along left side including arm down to elbow, front and back of left shoulder, as well as left side of neck and chest. This pain was most severe the first 2 days and lasted a total of about 5 days. On February 3rd , she started feeling cold symptoms and blood pressure went up to 164/93 , this decreased with a dose of her blood pressure medicine. Then starting on 2-11-21 she woke up with a racing heart and shortness of breath, on 2-12-21 a racing heart again occurred. She went to see her doctor who performed an EKG , found some abnormality and adjusted her heart/ blood pressure medications. Her doctor did not feel the heart and shortness and breath were due to vaccine specifically.
70 2021-02-28 palpitations Immediately felt sensation of medication moving throughout my body. Full body flush, racing heart, ... Read more
Immediately felt sensation of medication moving throughout my body. Full body flush, racing heart, Chills and nausea. Loss of balance upon walking. Slept for 11 hours following vaccination. Pain in injection site and painful lump appeared next to it. Headaches, body aches constantly, as well as constipation. It?s been 11 days since the shot and I still have a headache a small lump. The lump is slowly receding and no longer painful.
70 2021-02-28 fainting 13 min. after injection I had dizziness, feeling faint and sweating. Clinic gave me water and cold ... Read more
13 min. after injection I had dizziness, feeling faint and sweating. Clinic gave me water and cold rags. Pharmacist let me stay until I felt I could drive. I came home and took Tylenol for headache. 5 hrs later I felt extremely ill with joint pain , fever , dizziness. Vomiting occured during the night along with fainting. Next morning drank tea, no food. Slept all day until 5pm. Slept through night. Sun. still had extreme joint pain and headache. Was able to eat a light meal. Today I ate normally, went to physical therapy with a reduced routine. I still have a headache as of Mon. night. I know these seem like Normal side effects, but these were like having the worst Flu ever.
70 2021-03-01 low blood oxigenation, fainting Shortly after receiving the first dose of the vaccine, the patient started having profuse watery dia... Read more
Shortly after receiving the first dose of the vaccine, the patient started having profuse watery diarrhea on 2/11 and 2/12. She also stated she "fell out" on the same day. She was told to hydrate and then presented to the ED on 2/19 where she was found to be hypoxic down to the mid 80s. She was placed on 2L of O2 where her sat improved to 92%. She was febrile in the ED to 101.2 and had persistent fevers to 102.9 on the floor. COVID PCR testing negative x 2 and IgG positive. Patient received 6 days of antibiotics and supportive therapy. On 3/2 - Patient reports feeling better overall but still overall fatigue and not back to baseline. On 2-3 L NC. patient is still admitted
70 2021-03-01 fainting, heart rate increased Friday 2-26 had rapid heart rate despite taking ivabradine, fainted 3 times Sunday 2-28. All dysauto... Read more
Friday 2-26 had rapid heart rate despite taking ivabradine, fainted 3 times Sunday 2-28. All dysautonomia symptoms increased - sweating, extremities turning purple, syncope, indigestion, etc.
70 2021-03-01 fainting Vomiting, vertigo, fainting, migraine, nausea, body aches, fatigue
70 2021-03-02 blood pressure increased Patient stated that at 12:40 PM she began to fell itchy. Red 2 inch rash was present on the left wri... Read more
Patient stated that at 12:40 PM she began to fell itchy. Red 2 inch rash was present on the left wrist to hand area. 5 mm rash also appeared on the right forearm as well as small macular papules located on left and right antecubital areas. Vaccine site was warm to touch. No redness or rash noted in that area. Patient continued to be monitored. At 12:53 patient stated still feeling itchy. Given 10 mg tab of Zyrtec PO. As well as given ice pack to help with itching. Vitals at 12:55 PM were as follows T: 97.3, BP: 159/96, P: 86, RR:18. Patient monitored for an additional 15 minutes. At 13:10 vitals were as follows: T: 97.9, BP: 148/94, P: 76, RR: 18. No s/s of SOB or wheezing present. Patient instructed to follow up with primary care, ER, or urgent care regarding elevated BP as soon as possible and also in regards to hives and s/s of reaction to vaccine given if symptoms worsen. Patient alert and verbalized understanding and agreed to follow instruction
70 2021-03-02 heart rate increased Day after vaccine :Started with headache, sore arm; then pain down arm and pain in hand along veins... Read more
Day after vaccine :Started with headache, sore arm; then pain down arm and pain in hand along veins. Pain that caused jerking response. Chills all day. Fatigue. Easily sleeping at any time.. pain in legs and feet. Feelings of depression. Pain awakening me during the night. Hands cramped upon awakening. No fever at any time. Took Tylenol (2 tabs) every 4 hours around the clock. Next day: very tired. Headache. Rash on abdomen. Chills. Pain a bit better. No fever. Rapid heart rate at rest (pulse 95) . No fever. Mood much improved. Next day: only occasional pain. Today: tire easily. But much better.
70 2021-03-02 pallor About 12 hours after receiving the shot, my wife woke up to severe chills and shaking (with teeth ch... Read more
About 12 hours after receiving the shot, my wife woke up to severe chills and shaking (with teeth chattering). She advised that she couldn't even pick up and put on her glasses. She woke me and I was able to provide her a heating pad that over about 15 minutes reduced the shivering and chills. Her face was so pale that her freckles literally disappeared. I was ready to call 9-1-1, but she asked me not to (because they would not have let me go with her). So, I monitored her and gave her two Tylenols. For the ensuing 24 hours, she ran a 100-degree fever, had slight chills, and took Tylenol tablets periodcially.
70 2021-03-02 palpitations Severe arthralgias, Bell's palsy, nausea, vomiting, palpitations
70 2021-03-02 fainting PATIENT STATED TINGLING SENSATION ABOUT 15 MINUTES AFTER IMZ GIVEN, THEN SYNCOPE, THEN LOSS BODY FUN... Read more
PATIENT STATED TINGLING SENSATION ABOUT 15 MINUTES AFTER IMZ GIVEN, THEN SYNCOPE, THEN LOSS BODY FUNCTION 10 MINUTES LATER. CONSCIOUS ENTIRE TIME, ABLE TO BREATH ON OWN
70 2021-03-02 cardiac arrhythmia Fire Medic Response 70 Y/O Female L Arm Tingling PT had just received her 2nd Dose of Moderna Vacci... Read more
Fire Medic Response 70 Y/O Female L Arm Tingling PT had just received her 2nd Dose of Moderna Vaccine into Left Arm Upon observation PT stated that her Left arm was tingling, Head Tingling Paramedics On Scene assessed PT and Began 911 EMS local response, Upon assessment PT had multi-focal PVC's, Positive Orthostatics. Transported PT via ambulance to Hospital "Moderna Covid19 EUA"
70 2021-03-03 chest discomfort, hypertension, heart rate increased Rapid heartbeat, high blood pressure, pressure around heart, pink eye
70 2021-03-03 fainting, blood glucose increased Within seconds (less than a minute) after receiving the injection, the patient had a syncopal episod... Read more
Within seconds (less than a minute) after receiving the injection, the patient had a syncopal episode, was unresponsive (prior to vaccination reported feeling fine, was alert, appropriately conversant). She was lowered to the floor, BP 190/90, pulse 60's, respirations normal, pulse ox 96%, glucose 229. After being lowered to the supine position she fairly quickly became responsive. After a few minutes we tried to sit her up again, and again she became non-responsive. We laid her back down, she again became responsive within less than a minute. After a few more minutes we tried to sit her up again, she had another syncopal episode, again non-responsive. We called for EMT transport to the hospital.
70 2021-03-04 blood pressure increased within 10 minutes I started to sweat and my Blood Pressure went up. I stayed half and hour. I went h... Read more
within 10 minutes I started to sweat and my Blood Pressure went up. I stayed half and hour. I went home fine and then around 4:30-4:45 I woke from a nap and I had a rash that was itchy across my chest on the right side and it lasted an hour and then went away.
70 2021-03-04 heart rate increased Sucralfate 1gram 1tablet 4 times a day, Omeprazole DR 40 mg 1 a day. Muscle cramps in sever... Read more
Sucralfate 1gram 1tablet 4 times a day, Omeprazole DR 40 mg 1 a day. Muscle cramps in several areas at the same time. Dizzy, burning in my stomach and large intestines. nauseous, stool turned yellow for 7 days and burned my rectum, was very painful!! Then there was blood in my stool. I was also weak. I'm afraid to take second shot because of the issues I had with the first shot!! I have never experienced anything like that before. My stomach was so swollen I was afraid it would burst.I was having trouble breathing, short of breath when I walked. Heart rate would would go to 111 beats on Friday but that got better.
70 2021-03-04 loss of consciousness Patient reported waking up the morning after her second dose of the Moderna COVID-19 shot fine, but ... Read more
Patient reported waking up the morning after her second dose of the Moderna COVID-19 shot fine, but within 5 minutes of waking she began sweating profusely, vomited, and passed out. She reported that the sweating and nausea persisted for about a day and a half and that she is feeling mostly better today (2 days later)
70 2021-03-05 chest discomfort, fast heart rate Immediate tachycardia double resting heart rate lasting about 1 1/2 hours Mild itching no rash ... Read more
Immediate tachycardia double resting heart rate lasting about 1 1/2 hours Mild itching no rash Chest tightness without shortness of breath approximately 1/2 and hour to 45 minutes after injection. No respiratory symptoms at all, urinary incontinence - History of some leakage but not bladder emptying - x 2 an hour and an hour and a half after injection I am a nurse, I relayed tachycardia to pharmacist was given water felt better and left after 30 minutes but symptoms persisted and chest tightness followed and itching began I drove to urgent care and waited for them to pass with the plan that if they worsened or did not pass I would go in and be seen After and hour and a half I left to drive home, pulled over because of incontinence, continued home where my heart rate ( usually 60 at rest ) remained in 70 to 80 range ( on fit bit and by pulse taking ) for another hour or so and then normalized and all symptoms resolved.
70 2021-03-05 heart rate increased Warm flush from the injection site up the neck and across the chest. Elevated heart rate. Sharp pai... Read more
Warm flush from the injection site up the neck and across the chest. Elevated heart rate. Sharp pain in back just above the waist. Dizziness. Labored breathing. Lasted about 10 minutes. Fatigue came after an hour. Not as bad now. Still fatigued 7 days later.
70 2021-03-06 chest discomfort, blood pressure increased, loss of consciousness, fainting After the first vaccine, patient stated she had chest and throat tightness for 7 days. After the se... Read more
After the first vaccine, patient stated she had chest and throat tightness for 7 days. After the second vaccine, 5 minutes later, patient stated she had severe dizziness, shortness of breath, fainted, shaking, elevated blood pressure to 161/70, passed out. A facility called 911 for the patient. Patient was taken to the emergency room and treated with Ativan and meclizine. 2 EKGs and CXR in ER were normal. Patient spend 1 night in the hospital. The next day, all symptoms returned. Patient was treated with benadryl, zofran, and meclizine. Patient is still taking meclizine for dizziness. Patient was treated as an outpatient with oral steroids. 2 weeks later, patient is still havng symptoms, but milder.
70 2021-03-06 loss of consciousness Chilled, nauseous, gastric distress, weak, no appetite, miserable, passed out 3 times
70 2021-03-07 blood glucose increased, troponin increased Pt with h/o myasthenia gravis presents to ED with 3 week h/o worsening weakness. Unclear exact timin... Read more
Pt with h/o myasthenia gravis presents to ED with 3 week h/o worsening weakness. Unclear exact timing on onset relative to vaccine administration but appears to have been a few days later. During these 3 weeks, patient also diagnosed and treated for a UTI but patient had worsening of weakness leading to falls x2 a few days before presenting to hospital ED. On admission to hospital, pt diagnosed with myasthenic crisis treated initially with non-invasive mechanical ventilation and plasmapheresis. DDx included UTI with encephalopathy and confusion related to it.
70 2021-03-07 chest pain The patient received her 1st COVID-19 vaccination and during the post-vaccination observation period... Read more
The patient received her 1st COVID-19 vaccination and during the post-vaccination observation period developed left-side chest pain that radiated to her left scapula. Patient was brought to the emergency department but by that time the chest pain had subsided significantly but the left scapular pain remained. The patient was given 243 mg of aspirin and work-up consisted of ECG and Chest CT scan. Pain was deemed to be non-specific and patient was discharged in good condition.
70 2021-03-08 chest pain Injection site pain deep in arm , stillsore to touch, no external reaction, BUT, pain has spead & ... Read more
Injection site pain deep in arm , stillsore to touch, no external reaction, BUT, pain has spead & accelerated to whole r arm, chest, shoulder, clavicle & scapula , with hand pain & numbness. Stabbing pain over deltoid inj site. Sleeping impossible- pain unresolved by medication.i cannot lie down, even when sitting, site hurts to touch.
70 2021-03-08 palpitations 3/1/2021 Caller with hx of Afib corrected by surgery woke up at 06:00 this morning with a racing he... Read more
3/1/2021 Caller with hx of Afib corrected by surgery woke up at 06:00 this morning with a racing heart like she feels used to feel with her afib. She is also dizzy and having a hard time breathing (observed from exertion of talking while on the call). No hospital care yet, but a nurse friend said her HR seems irregular to her. 3/2/2021 Follow up call: Still has difficulty breathing Patient can't really explain. Felt like she did when had A-fib. Palpitations largely Tired This AM, but did not sleep well tonight. Call into Cardiologist for possible appt and further care. 3/7/2021 Follow up call: Caller is feeling a lot better this week. She is still mildly SOB but her Afib episode seems to have resolved. She has been in continuous contact with her Cardiologist and has an appt. this upcoming Tuesday. They did say on the phone she is not the first person to report this event to them after receiving the COVID vaccine. Caller provides DOB so that this AE can be adequately reported.
70 2021-03-08 fast heart rate, loss of consciousness Loss of consciousness; Could not think straight; Difficulty walking; Having difficulty speaking; Fas... Read more
Loss of consciousness; Could not think straight; Difficulty walking; Having difficulty speaking; Fast heart beat; Dizziness; Gums began tingling; Gums itching; A spontaneous report was received from a consumer concerning a 70-year-old, female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced events Loss of consciousness, difficulty in walking (difficulty walking), Mental Impairment(couldn't think straight), Dysarthria(difficulty speaking), Tachycardia(fast heart beat), Dizziness, Paraesthesia oral (gum tingling) and Gingival pruritic(gum itching). The patient's medical history was reported as seizure disorder, diabetic, and allergies. Concomitant medications known to have been used by the patient, within two weeks prior to the event included amlodipine, Aspirin, Benadryl, azosemide, fara sulfate, levothyroxine, losartan, magnesium oxide, metformin, meloxicam, Minoxidil, montelukast , omeprazole, potassium chloride er, primidone, propranolol, rosuvastatin, stool softener, Tylenol extra strength, vitamin D3, voltaren topical gel and tramadol On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010A21A) intramuscularly for prophylaxis of COVID-19 infection. On 25 Feb 2021, the patient experienced the difficulty walking, couldn't think straight, difficulty speaking, fast heartbeat, dizziness, loss of consciousness, gum tingling and gum itching. Laboratory details were not provided. Treatment details was given as Tylenol and Ativan. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event Loss of consciousness was reported as resolved. The outcome of the event, Gait inability, Mental Impairment, Dysarthria, Tachycardia, Dizziness, Paraesthesia and Gingival pruritis were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
70 2021-03-09 loss of consciousness After my second vaccination shot on 3/5/21 I started with a low grade fever on 3/6/21. On 3/7/21 af... Read more
After my second vaccination shot on 3/5/21 I started with a low grade fever on 3/6/21. On 3/7/21 after getting up I started feeling funny while going to the restroom. I laid on the floor for a while and then proceeded to the couch. I passed out on the couch. Upon waking up I was sweating very bad. My clothes were wet.
70 2021-03-09 loss of consciousness Pt reports that after receiving her vaccine at 11:15AM, she waited until 11:35AM to leave. No advers... Read more
Pt reports that after receiving her vaccine at 11:15AM, she waited until 11:35AM to leave. No adverse reactions at that time. Within 5-10 minutes of leaving, she reports dizziness and lightheadedness that started and continued all night. Upon waking 03/05/2021, the dizziness/lightheadedness continued. After getting up out of bed, she reports LOC for unknown length of time around 8:15AM. Head injury occurred at the time of the fall. Another incident of LOC for < 5 minutes occurred at 12:00PM. Husband took to the ER, 4 staples to the back of her head. CT of head was negative.
70 2021-03-09 heart attack On 3/4/21, @ 2:pm, I had a very severe pain between my shoulder blades that took my breath away, th... Read more
On 3/4/21, @ 2:pm, I had a very severe pain between my shoulder blades that took my breath away, that radiating to the front of my check. I put an aspirin under my tongue, walked around and had some water. Pain kept getting worse. My husband drove me to the ED got there at 4pm. They took blood, did chest x-ray, ekgs. Blood work showed my Troponin level @ .11 and later elevated to 2.1. My blood pressure was 215/99, temp 97. I started having pain in my right shoulder & right wrist. I was diagnosed with a slight heart attack. On Friday, 3/5/21, facility did an angiogram, which showed my arteries were clear, no blockage or plaque, no heart damage. Did show it appeared the arteries had gone into a spasm which may have caused the heart attack. I saw my primary Dr on Monday, 3/8/21, and she said I have no history of heart problems, no high cholesterol, etc. I asked her if this could be a side effect of my vaccine. Dr. said it was a good question & she didn't know the answer, since not all the research has been done. She suggested I submit my question to VAERS! I'm now taking Aspirin 81 mg, daily, Bisoprolol 5 mg Tab, Losartan 25 mg Tab, DOK 100 mg Cap.
70 2021-03-10 chest discomfort coughing and then chest tightness
70 2021-03-11 cardiac arrest cardiac arrest death
70 2021-03-11 excessive bleeding Note: after giving shot nurse said WOOPS - blood dripping down my arm. 4 hours later arm VERY sore.... Read more
Note: after giving shot nurse said WOOPS - blood dripping down my arm. 4 hours later arm VERY sore. 6 hours later arm VERY VERY sore. No sleep, hot and cold flashes, significant aches esp. in legs (even my eyeballs hurt!). Pain resolved by AM. Next day arm got a bit itchy. 3 days later arm itched like I had poison ivy and fingers / hands had pain and joint swelling. Used a prescription steroid cream on arm and that resolved itching. Hands, fingers took 10 days to return to normal. All in all 14 days to recover completely from 2nd Moderna Covid shot.
70 2021-03-11 heart rate increased, chest discomfort The patient had tightness of chest, rapid pulse, and tingling of the legs. She was checked out by p... Read more
The patient had tightness of chest, rapid pulse, and tingling of the legs. She was checked out by paramedics and released.
70 2021-03-11 palpitations, chest pain chills, racing heart, pain in chest, difficulty breathing, weakness
70 2021-03-12 body temperature decreased on the evening of the 19th Feb -started to itch and got red by Saturday morning red lesion about 2... Read more
on the evening of the 19th Feb -started to itch and got red by Saturday morning red lesion about 2 inches around-the injection shot very itchy and swollen . had chills- but body temp dropped to 92.6 with upset stomach- sunday was my worst day- could not do mush of anything felt sick for the rest of the week- feeling a little better each day-i had the Moderna Covid-19, 8th day ARM
70 2021-03-14 nosebleed Patient reported nose bleed that required ER visit to stop. Patient taking Xarelto. Reported BP>140,... Read more
Patient reported nose bleed that required ER visit to stop. Patient taking Xarelto. Reported BP>140, no fever.
70 2021-03-14 loss of consciousness Had nausea, vomiting, diarrhea, and then I passed out and hit my head, shoulder, and arm resulting ... Read more
Had nausea, vomiting, diarrhea, and then I passed out and hit my head, shoulder, and arm resulting in multiple bruising.
70 2021-03-15 blood pressure fluctuation Blood pressure up and down; Vaccine was purple and not clear in vial; A spontaneous report, was rece... Read more
Blood pressure up and down; Vaccine was purple and not clear in vial; A spontaneous report, was received from a consumer (patient), a 70 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced blood pressure up and down (blood pressure fluctuation), and vaccine was purple and not clear in vial (product colour issue). The patient's current conditions included allergy to dye and anaphylaxis. Concomitant medications were not reported. On 24 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for the prophylaxis of COVID-19 infection. On an unknown date in Feb 2021, after receiving the vaccine, the patient had her blood pressure up and down. The patient stated that the vaccine was purple and not clear in the vial on 24 Feb 2021, and still the pharmacist gave her. The patient was hospitalized for her blood pressure fluctuations. Treatment information was not provided. Action taken with second dose of mRNA-1273 in response to the events was not provided. The outcome of the event, blood pressure up and down was not reported and that of event vaccine was purple and not clear in vial was recovered on 24 Feb 2021. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded. Further information has been requested.
70 2021-03-15 blood pressure increased Elevated blood pressure, which is coming down but 10 days later is still not normal; Sore arm (last... Read more
Elevated blood pressure, which is coming down but 10 days later is still not normal; Sore arm (lasted 2 days- ice pack helped).
70 2021-03-15 chest discomfort Patient received second dose of Moderna at 11:45 PM and went to waiting area for 30 min wait. She h... Read more
Patient received second dose of Moderna at 11:45 PM and went to waiting area for 30 min wait. She has a h/o anaphaxisis type reaction to IVP dye. No problems reported with first dose of vaccination. At 12:03 PM, writer was summoned to waiting area as patient was c/o chest pressure. Patient had frequent coughing. Denied SOB. States that she forgot her albuterol inhaler at home. Denies throat closure. Reports feeling sweaty and c/o chest pressure. Lungs with upper airway wheezing. Frequent dry-sounding cough. VSS. First responder called to assist with prompt arrival. Initially, patient reported that symptoms were improving. Still with frequent cough. Then c/o throat tightness. Was taken to ED via wheelchair accompanied by her husband.
70 2021-03-15 heart rate increased Lost her vision; Dizzy, lightheaded, lightheadedness; Increased heart rate; A spontaneous report was... Read more
Lost her vision; Dizzy, lightheaded, lightheadedness; Increased heart rate; A spontaneous report was received from a consumer concerning a 70-years-old female patient who was received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of vision, dizziness and increased heart rate. The patients medical history was not provided. No relevant concomitant medications were reported. On 28 feb 2021, approximately three days prior to the onset of events loss of vision, dizziness and increased heart rate, the patient received the first of two planned dose of mRNA-1273(Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 02 mar 2021, The patient had lost her vision, became dizzy lightheaded, which led to an increased heart rate. The patient still had intermittent lightheadedness. The event loss of vision was medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events loss of vision, dizziness and increased heart rate was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
70 2021-03-16 oxygen saturation decreased, fluid around the heart Two week after receiving the Moderna vaccine, patient started to have a high fever, body aches all o... Read more
Two week after receiving the Moderna vaccine, patient started to have a high fever, body aches all over, coughing, congestion, and oxygen levels would not remain stable. On 3/15 she was admitted the hospital. She is still currently in the hospital and her blood oxygen levels remain around 80. She has fluid in her lungs and around her heart. Her liver enzymes remain highly elevated.
70 2021-03-16 palpitations march 4th,bliters on back and waistline, hip, knees, march 11-left hip pain, , march 12th low grade ... Read more
march 4th,bliters on back and waistline, hip, knees, march 11-left hip pain, , march 12th low grade temp, march 13th, chills, body aches back and joint pain, left lower back, heart palpitations, difficulty lifting head
70 2021-03-16 fainting, loss of consciousness I awoke this morning feeling feverish. I walked to the kitchen to take tea and a Curamin tablet... Read more
I awoke this morning feeling feverish. I walked to the kitchen to take tea and a Curamin tablet since I had run out of Advil.. I began to feel as though I was going to vomit so walked slowly to the toilet, knelt in front, then made a quarter turn,, thinking this would not happen, and I fainted/blacked out. I found myself face down in front of toilet and a good bump on my right eyebrow....face turned inward. I stayed still long enough to feel safe to rise and so did. No more sense of vomiting, thank goodness. Just very very tired. I did make oatmeal with blueberies for breakfast and ate this slowly. Just wanted to ask if this is to be expected. It is now four hours fifteen minutes since this happened. As I walk carefully , I am trusting all will be well ...but when?
70 2021-03-16 transient ischaemic attack, blood clot The next day, I had short term memory loss. I went to the hospital, and they said I had some type of... Read more
The next day, I had short term memory loss. I went to the hospital, and they said I had some type of heart episode. I was taken by ambulance to the hospital and was told I had a blood clot in my brain and had suffered a mini stroke. I was hospitalized for 4 nights. I was given blood thinner and I improved.
70 2021-03-17 heart rate increased, palpitations The patient had her first moderna vaccine on 2/3/2021 and developed a rash on her left arm on 2/11 w... Read more
The patient had her first moderna vaccine on 2/3/2021 and developed a rash on her left arm on 2/11 where she got the vaccine, and a few days later developed a tachycardic episode with HR raising to 115. It returned to normal after a short while. Patient had second moderna vaccine on 3/3/2021. She developed a pruritic rash on her upper body including her torso on 3/14 . She was asked to take benadryl and pepcid on 3/15. She took 175 mg benadryl over the course of 48 hours. Early on the morning of 3/18 she woke up with palpitations which lasted for over an hour and her HR rose to as high as 160.
70 2021-03-17 fainting fainted and woke up on floor; sweating thru pajamas; throwing up; sore arm; A spontaneous report was... Read more
fainted and woke up on floor; sweating thru pajamas; throwing up; sore arm; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm,, fainted and woke up on floor, sweating through pajamas and throwing up. The patient's medical history was not provided. Concomitant medications reported were unspecified statin, blood pressure medication, antiviral medication. On 02 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20H) intramuscularly for prophylaxis of COVID-19 infection. On 02 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly for prophylaxis of COVID-19 infection. On 02 Feb 2021, the patient experienced the event, sore arm. On 03 Mar 2021, the patient fainted in the kitchen and woke up on floor. The patient reported sweating through pajamas and started throwing up. Patient did not take any treatment for second dose events. Action taken with mRNA-1273 in response to the events was not applicable The event, fainted, was considered resolved on 03 Mar 2021. The outcome of events sore arm, sweating and throwing up were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
70 2021-03-17 fainting Can not lift my arm as of 3/18 and excruciating pain nite of 16 and 17 . Extra strength Tylenol did ... Read more
Can not lift my arm as of 3/18 and excruciating pain nite of 16 and 17 . Extra strength Tylenol did not phase pain. Pain eased up on 3/18 but still minimum movement. Chills on 16 ,17. Fainted on 3/17 at 3:30 a.m. when I went to get a drink of water.
70 2021-03-17 troponin increased Symptoms began 2 hours after dose, including headaches, myalgias, and lower extremity weakness. Trie... Read more
Symptoms began 2 hours after dose, including headaches, myalgias, and lower extremity weakness. Tried Tylenol with no relief. Symptoms progressively worsening. Fell and hit head the following day, denied loss of consciousness. Never had a reaction to vaccine before. No response to first dose. No lightheadedness/presyncope prior to falls. Came to ED after fall (evening of the day after receiving the vaccine). Found to have elevated troponin. CK elevated, aggressive fluid repletion initiated, determined to be in rhabdomyolysis. Hypokalemic. Patient improved with fluids and electrolytes, determined to be stable for discharge after 2 days.
70 2021-03-18 atrial fibrillation Vibrating from my waist to my neck; Atrial fibrillation; Really tired; Felt lousy; Extreme thirst; I... Read more
Vibrating from my waist to my neck; Atrial fibrillation; Really tired; Felt lousy; Extreme thirst; I've lost 8 lbs from the last month or two; A spontaneous report was received from an consumer concerning a 70 years old, female patient who experienced atrial fibrillation, tired out, vibrating from waist to neck, felt lousy, extreme thirst and lost 8 lbs last month. The patient's medical history was not provided. Concomitant product use was none by the reporter. On 01 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 027L20A) in left arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number not provided) in left arm for prophylaxis of COVID-19 infection. The patient experienced the events tired since an unknown date in Feb 2021; vibrating from my waist to my neck, atrial fibrillation, felt lousy, extreme thirst and lost 8 lbs last month all since 06 Feb 2021. The patient was hospitalized on 06 Feb 2021 and was discharged on 07 Feb 2021. Laboratory investigations included echocardiogram which "turned out ok" and EKG "was ok" both performed on an unknown date in Feb 2021. Treatment for the event included diltiazem and Eliquis both since an unknown date for an unknown indication. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events felt very tired, vibrating from my waist to my neck, atrial fibrillation, felt lousy, extreme thirst and lost 8 lbs last month were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
70 2021-03-18 chest pain About 5 minutes after receiving 2nd dose of Moderna vaccine client began complaining of chest pain, ... Read more
About 5 minutes after receiving 2nd dose of Moderna vaccine client began complaining of chest pain, and feeling of throat closing. RN and EMT present at client's side. Noted that lungs had crackles. EMT gave a total of 324 mg of Baby Aspirin at 1630 (Four 81mg tablets). At this time client's BP was 197/98. At 1633 EMT gave one 0.4mg dose of Nitro sublingual. Client's BP at this time was 176/87. Ambulance arrived and took client to hospital.
70 2021-03-18 heart rate increased Bounding heartbeat ranging 104-114 checked twice, at rest for extended period on day 1 and day 2 We... Read more
Bounding heartbeat ranging 104-114 checked twice, at rest for extended period on day 1 and day 2 Weakness and dizziness
70 2021-03-19 chest discomfort Complaints of chest tightness, nausea, throat swelling, left arm pain
70 2021-03-20 chest discomfort The patient described that right after the vaccination she had black spots in front of her eyes, che... Read more
The patient described that right after the vaccination she had black spots in front of her eyes, chest tightness, staggering to walk. She still had these symptoms while she was in the store and the following day. She plans to see her dr for her regular appointment on Thursday 3/25,but is going to discuss the adverse events with him. She reported to me on Saturday 3/20/21 that she was feeling better.
70 2021-03-20 deep vein blood clot R subclavian occlusive DVT, currently on oral anticoagulation with xarelto Symptoms: discoloration/s... Read more
R subclavian occlusive DVT, currently on oral anticoagulation with xarelto Symptoms: discoloration/swelling of R arm Symptom with vague onset, starting ~3/8/21
70 2021-03-20 heart rate increased Chills, muscle pain, nausea, fever Difficulty breathing redness on face Fast Heartbeat, dizziness... Read more
Chills, muscle pain, nausea, fever Difficulty breathing redness on face Fast Heartbeat, dizziness and weakness
70 2021-03-20 loss of consciousness, fainting Following the day after my 2nd dose of Moderna I lost consciousness, collapsed, hit my head on metal... Read more
Following the day after my 2nd dose of Moderna I lost consciousness, collapsed, hit my head on metal handle in kitchen, required 8 staples on the gash on backside of my head and two days hospital stay.
70 2021-03-20 pallor much swelling and soreness right upper arm where vaccine given few hours after injection. Day after ... Read more
much swelling and soreness right upper arm where vaccine given few hours after injection. Day after injection headache .fatigue. aching pale color white as a ghost lasted one day. severe itching whole upper right arm started 2 days after injection and continues off and on since. Apply hydrocortisone to site for relief from itching.
70 2021-03-20 fainting, loss of consciousness Following the day of my 2nd dose of Moderna vaccine I lost consciousness shortly after getting up in... Read more
Following the day of my 2nd dose of Moderna vaccine I lost consciousness shortly after getting up in the morning, collapsed, hit my head on metal drawer handle in the kitchen, required 8 staples on a gash on backside of my head and a two-day hospital stay.
70 2021-03-21 chest discomfort shakiness, nausea, chest tightness
70 2021-03-21 loss of consciousness, fainting Fainting/Loss of consciousness. Fall.
70 2021-03-21 fainting stared with a metallic taste in mouth and fatigue. next day nausea light headed and fainted. Body ac... Read more
stared with a metallic taste in mouth and fatigue. next day nausea light headed and fainted. Body aches and no appetite, joint aches.
70 2021-03-22 chest discomfort Injection site soreness, chills, muscle aches onset at 28 hrs after injection; have not yet subsided... Read more
Injection site soreness, chills, muscle aches onset at 28 hrs after injection; have not yet subsided. Nausea, chest tightness onset at 34 hours post injection; subsided after 2 hours.
70 2021-03-22 chest discomfort not quite 2 days later, i started having trouble breathing, and i had not had any symptoms of the as... Read more
not quite 2 days later, i started having trouble breathing, and i had not had any symptoms of the asthma or the COPD because i only experience trouble breathing after a case of the flu or a severe cold, which always leads to congestion, and often pneumonia. There was constant coughing and gasping for air, a tightness in my chest. I went online to see if there were any other people who had experienced this, and the literature was saying the problems with breathing usually start within a few hours, but mine took longer and I know it was related to the vaccine. I was given an ADVAIR inhaler which did nothing to alleviate the symptoms, so then had 3 weeks of prednisone, to the point i did not want to go for the second dose, but my doctor talked me into it as I have so many pre-existing conditions. I had no problem at all with the second dose and am now off the prednisone and the advair
70 2021-03-22 chest pain, pulmonary embolism 2/10/21- RECEIVED MODERNA; 2/11/2021- FEVER AND FATIGUE; 2/19/2021- CHEST PAIN AND SHORTNESS OF BREA... Read more
2/10/21- RECEIVED MODERNA; 2/11/2021- FEVER AND FATIGUE; 2/19/2021- CHEST PAIN AND SHORTNESS OF BREATH; 2/20/2021- CONTINUED CHEST PAIN AND SHORTNESS OF BREATH- ER VISIT (ADMITTED FOR PULMONARY EMBOLISM); 2/23/2021- DISCHARGED FROM HOSPITAL TO HOME
70 2021-03-23 atrial fibrillation Atrial fibrillation; A spontaneous report was received from a consumer concerning a 70 years old fem... Read more
Atrial fibrillation; A spontaneous report was received from a consumer concerning a 70 years old female patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Atrial fibrillation. The patient's medical history was not provided. Concomitant medications reported included LEVOTHYROXINE(75mcg daily), HYDROCHLOROTHIAZIDE(25mg daily), CO Q10(200mg daily), VITAMIN D (2000iu daily), VITAMIN, RESTORE VITAMIN, BIOTIN (5000mcg daily), NEXIUM(daily), ATIVAN(0.5mg as needed for sleep), METFORMIN (500mg three times daily), METOPROLOL ER (25mg daily), ELIQUIS( 5mg twice daily), POTASSIUM CHLORIDE ER (10meq twice daily). On 05 Feb 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273(Lot number: 010MZ0A ) vaccine intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, patient reported that 3-4 hrs later she had Atrial fibrillation where her heart rate reached 170. She went to the ER and they were able to convert within a couple of hours. Patient reported that she had no prior history. The event was considered to be medically significant. Treatment for the event included Metoprolol ER 25mg daily. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event Atrial fibrillation is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
70 2021-03-23 heart rate irregular, palpitations, palpitations I became chilled and was shaking uncontrollably. My heart was racing ( I did not take pulse) for app... Read more
I became chilled and was shaking uncontrollably. My heart was racing ( I did not take pulse) for approximately 30 minutes (only a guess - seemed like an hour) My heartbeat was also irregular - skipping a beat every 5 to 15 beats for about an hour. For the next 48 hrs, I had severe headache, extreme fatigue, nauseousness, appetite loss, and some lung and nasal congestion. I slept most of the time
70 2021-03-23 loss of consciousness passed out; hurt her knee and ankle; tired; headache; chills; flu-like symptoms; A spontaneous repor... Read more
passed out; hurt her knee and ankle; tired; headache; chills; flu-like symptoms; A spontaneous report (United States) was received from a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passing out, tired, headache, chills flu-like symptoms and hurt her knee and ankle. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10-MAR-2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly for prophylaxis of COVID-19 infection. On 10- Mar-2021, after receiving the vaccine, the patient experienced tired, headache, chills like flu symptoms and passed out and hurt her knee and ankle. The patient felt better at the time of this report. The seriousness criteria for the event passed out was considered as medically significant. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of event(s) experienced passed out, tired, headache, chills like flu symptoms and hurt her knee and ankle was recovering/ resolving. The reporter did not provide the assessment for the event's, passed out, tired, headache, chills like flu symptoms and hurt her knee and ankle.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
70 2021-03-23 pallor, palpitations Patient received second dose of Moderna on 3/24/21. Patient was feeling fine after shot and waited f... Read more
Patient received second dose of Moderna on 3/24/21. Patient was feeling fine after shot and waited for her husband to receive his vaccine. She was shopping around in the store and stated that she didn't feel well. After a few minutes, her husband ask for us to observe her. She was pale and stated that her head hurt and her heart was racing. It was recommended that she go to the ER for evaluation.
70 2021-03-23 lightheadedness, chest discomfort beginning 20 minutes after the vaccine, patient had near syncope and shortness of breath. no hives ... Read more
beginning 20 minutes after the vaccine, patient had near syncope and shortness of breath. no hives or flushing. fatigue persisted several days after, along with chest discomfort, worrisome for anaphylaxis reaction.
70 2021-03-24 chest discomfort, heart rate increased, fast heart rate MODERNA COVID-19 VACCINE EUA 1:45 while playing 9 holes of golf, experienced lightheadedness, dizzin... Read more
MODERNA COVID-19 VACCINE EUA 1:45 while playing 9 holes of golf, experienced lightheadedness, dizziness, headache and vision blacked out momentarily. Heart racing tremendously; experienced left arm tingling pain, tightness in chest and then severe jaw pain. Golf partner called EMS, took one tab of Nitroglycerine and 4 81mg of of Aspirins. EMS arrived at golf course, heart rate remained high; between 190 to 204. Got me inside of ambulance and issues a heart stopping drug to reset the heart. Admitted to Medical Center within the next 2 hours. Several EKGs, blood work, etc., showing some heart damage. Sent home on 3/5/2021 with diagnosis of SVT (supraventricular tachycardia); monitoring accordingly now. Wore heart monitor for 15 days. Still SOB (short of breath); upper back pains, sharp shooting pains in left upper part of back radiating into the heart area, and other issues; dizziness and malaise (very tired). Before shot was working out, walking, playing golf, dancing. Performing many duties of household experiences with never any issues.
70 2021-03-24 fainting 3/17/21 Chills from 12;30 am until 7:30 am. 7:30 am felt very very ill. had temp of 101.7. ... Read more
3/17/21 Chills from 12;30 am until 7:30 am. 7:30 am felt very very ill. had temp of 101.7. All of a sudden I had Urinary incontinence. I started peeing in my bed. Asked my husband to help me to bathroom because I felt so sick. I fainted in his arms Got back into bed and had a horrible migraine. had to have my eyes covered and dark room I felt as though I was going to throw up for hours. Did not eat anything until 8 pm. some toast and tea. 3/18/21 Still sick but not as bad. Stayed in bed for 1/2 day. it was a slow go. 3/19/21 Still not myself. 3/20/21. Felt more myself.
70 2021-03-25 deep vein blood clot Blood Clot in Leg; A spontaneous report was received from consumer concerning a 70-years-old female ... Read more
Blood Clot in Leg; A spontaneous report was received from consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in leg. The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient included blood thinners for blood clot. On 21-Jan-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 013L20A) through intramuscular route on left upper arm for prophylaxis of COVID-19 infection. On 18-Feb-2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013M20A) through intramuscular route at right upper arm for prophylaxis of COVID-19 infection. On 23-Jan-2021, after the first dose patient developed leg pain. The patient reported of having the leg pain linger for about 2 weeks before seeing a healthcare professional. The healthcare professional had later found that the leg pain was related to the development of a blood clot. Relevant Treatment for the event was with blood thinner. The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcome of event, blood clot in leg was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
70 2021-03-25 palpitations Patient receive a covid19 moderna vaccine on 2/12/21 , on 2/15/21 she had facial swelling, heart rac... Read more
Patient receive a covid19 moderna vaccine on 2/12/21 , on 2/15/21 she had facial swelling, heart racing on 2/16/21 she had blood pressure over 200 and was admitted to emergency room.
70 2021-03-25 palpitations patient complained about dizziness and rapid heart rate 15 minutes after vaccine administration. BP ... Read more
patient complained about dizziness and rapid heart rate 15 minutes after vaccine administration. BP was 145/88, 143/95, 131/87- pulse 72,71,69 every 10 minutes. felt better after 1/2 hour and left home. called her 5 hours later, she was doing fine
70 2021-03-26 chest pain, hypertension Vaccine Dose #1 Swelling on bottom of both feet near toes. Painful when walking. Lasted 2 days ... Read more
Vaccine Dose #1 Swelling on bottom of both feet near toes. Painful when walking. Lasted 2 days Vaccine Dose #2 Nausea, Violent and frequent vomiting, chills, sweating, headache, dizziness left side chest pain, with body and joint pain. Cannot retain liquids. Unable to sleep. All symptoms lasted for about 24 hours. During adverse event: High blood pressure 180/100 due to stress and pain.( Normal Blood Pressure is 110/60. ) Pulse rate = 74-80 bpm, blood oxygen saturation = 96%, and oral temperature = 98.1 F event. 95% Recovered from symptoms 36 hours after start.
70 2021-03-27 chest pain, loss of consciousness sweating; Pain in arm; Fever; Chest pain (left side); No bowel movement-watery; Labored breathing; O... Read more
sweating; Pain in arm; Fever; Chest pain (left side); No bowel movement-watery; Labored breathing; Over sleeping; Passed out; Chills; Dizziness; Headache; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna COVID 19 vaccine and experienced pain in arm, dizziness, major chest pain (left side), pain in shoulder, neck, headache, no bowel movement-watery, chills, labored breathing, passed out, over sleeping, no urine, sweating, fever and sore throat. The patient's medical history included congestive heart failure, high blood pressure and gout and had 3 heart attacks in lifetime. No relevant concomitant medications were reported. On 12 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: 031A21A) intramuscularly for COVID-19 prophylaxis. On 12 Mar 2021, the patient experienced headache and dizziness. On 13 Mar 2021, the patient experienced pain in arm, major chest pain (left side), pain in shoulder, neck, no bowel movement-watery, chills, labored breathing, passed out, over sleeping, no urine, sweating, fever and sore throat. Treatment for the event included nitroglycerin and paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event dizziness was resolved on 12 Mar 2021. The outcome of the events chills, fever and headache was resolved on 14 Mar 2021. The outcome of the events pain in arm, major chest pain (left side), pain in shoulder, neck, no bowel movement-watery, labored breathing, passed out, over sleeping, no urine, sweating and sore throat was resolved on 15 Mar 2021.; Reporter's Comments: This case concerns a 70 Y/O F with a serious unexpected loss of consciousness and NS unexpected dizziness, chest pain, dyspnea, gastrointestinal motility disorder, hypersomnia, hyperhidrosis, and expected pain in extremity, pyrexia, chills, headache. Event onset Day 1 after first dose mRNA-1273. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
70 2021-03-28 chest discomfort First 24hours post vaccination: headache, arm pain (whole arm up to collar bone down to hands), chil... Read more
First 24hours post vaccination: headache, arm pain (whole arm up to collar bone down to hands), chills, and body aches 48 hours post vaccination: developed Covid19-like symptoms- shortness of breath, chest heaviness, body aches, extreme tiredness lasting for 7-10 days post vaccination. Minor effects may still be lingering. ** Note: Patient tested positive for Covid19 in November of2020 and symptoms 48 hrs post vaccination were similar to what she experienced with Covid19
70 2021-03-28 skin turning blue Got the vaccine, and a few hours later started getting tingling on her lips. Later that night she s... Read more
Got the vaccine, and a few hours later started getting tingling on her lips. Later that night she started getting fever blisters, low grade fever and nausea, left sided face swelling inside and out. She has fever blisters in her mouth, and her lower lip is also being affected. The lower lip still has the blisters/bluish color for them. She is taking Lypsyl ointment to keep her lips moistened. She called her doctor and prescribed her Valacyclovir, which did not help at all. She was on it 7 days. She went back to her PCP and told her that it did not work, and could not believe it didn't work, so is not on anything at this time.
70 2021-03-30 cerebrovascular accident On 3/15/2021 pt was trying to use her computer when she started having problems with her vision. Sh... Read more
On 3/15/2021 pt was trying to use her computer when she started having problems with her vision. She noticed her left hand was clumsy and awkward. Her left leg would not operate properly. She could not swallow pills with water and her speech was slowed and slurred. She went to the Hospital ER. They did MRI, CT, blood test that showed she had a small stroke. She was released to go home to do physical therapy and speech therapies. She has both of these scheduled and will follow up w/ PCP on 4/23/2021.
70 2021-03-30 chest discomfort Per Fire EMS on site client reported "tightness in her chest and flushed feeling" after receiving CO... Read more
Per Fire EMS on site client reported "tightness in her chest and flushed feeling" after receiving COVID vaccine. She sat in observation for 25 minutes and then was in the eval room for another 30 minutes. Symptoms resolved and she went home accompanied by husband.
70 2021-03-30 nosebleed, loss of consciousness Passed Out in Bathroom; Bloody Nose; Nausea; A spontaneous report was received from a consumer conc... Read more
Passed Out in Bathroom; Bloody Nose; Nausea; A spontaneous report was received from a consumer concerning for his wife, a 70-year-old, female patient who received Moderna (mRNA-1273) vaccine and experienced events Bloody Nose/Epistaxis, Nausea, and passed out in the bathroom/Loss of consciousness. The patient's medical history was not provided. No relevant concomitant medications were provided by the reporter. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via an unknown route for prophylaxis of COVID-19 infection. On 17 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via an intramuscularly on Arm for prophylaxis of COVID-19 infection. On 17 Mar 2021, Bloody Nose, Nausea, and the consumer Passed Out in the Bathroom before being taken to the Emergency Room. Seriousness criteria for all events was considered as Hospitalisation. No Treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. The outcome of the events, Bloody Nose, Nausea, and passed out in the Bathroom was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
70 2021-03-30 heart rate increased, chest discomfort First when leaving site after 15 min. I felt weird (only way to explain it). Once I arrived home I ... Read more
First when leaving site after 15 min. I felt weird (only way to explain it). Once I arrived home I started haveing a sever headache as the light on my eyes hurt. I was very sick to my tummy, felt hot/then cold. I felt after a couple hours I should try to walk it off - but could only walk to end of block. sat down for a while and the sounds and light were making me sicker. I got up from neighbors house as she felt I should go lay down This is now 4 hours after shot. I got up and was very dizzy. walked back to house and laid down. very dizzy, I tried hard to relax, but decided I should eat a little something even though tummy was sick. I had a little bite to eat and laid back down. I finally took my heat rate, now about 5 hours after shot and AT REST IT WAS 90. my normal rate is 57-63 at rest. I drank water and stayed in bed the rest of the day,, although I did not sleep all night. Next day go up and felt the same. but my heart rate was lower at rest to 63. I was hot/cold all day, felt sick and very very tired. I rested that day as well and rested for 3 days. I made myself walk my dog, but no energy. I made myself eat, but not really hungry, food tasted different. and to this day still does. I am still feeling very tired and get hot/cold, but after almost two weeks feeling better. I don't take flu shots because I get sick, I got very sick on this shot. too bad you don't tell these stories on the news. I am healthy don't take drugs, hardly take a aspirin.! I am in good health but now feel my chest is heavy and still tired.
70 2021-03-30 loss of consciousness Extreme dizziness that began with sweating. Went to the bathroom as if felt nauseous. Blacked out. (... Read more
Extreme dizziness that began with sweating. Went to the bathroom as if felt nauseous. Blacked out. (Hit head, which is still bruised and had urinated.) When woke up still very dizzy with vomitting, stomach cramps, dhiaria, continued sweating. This lasted two--three hours. I could not leave the bathroom. Made it to my bed with help. Finally slept for a few hours. Awoke with continued stomach cramps and moderate dizziness. Stomach cramps on and off for the next 24 hours. Unable to get out of bed.
70 2021-03-30 fainting Practically fainted; Shortness of breath; Tingling in right hand; Numbness; Brain fog; Feels weak; S... Read more
Practically fainted; Shortness of breath; Tingling in right hand; Numbness; Brain fog; Feels weak; Soreness; Itchiness; Fatigued; A spontaneous report was received from a consumer concerning a 70-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness, tingling in right hand, fatigued, practically fainted/Syncope, feels weak, itchiness, soreness, shortness of breath, brain fog. The patient's medical history was not provided. Concomitant medications were not reported. On 21 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number:028L20A) unknown route of administration in the left non-dominant arm for prophylaxis of COVID-19 infection. On 18 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number:031L20A) unknown route of administration in the left non-dominant arm for prophylaxis of COVID-19 infection. On an unspecified date, the patient practically fainted, felt numbness, tingling in right hand, felt fatigued, feels weak, itchiness, soreness, shortness of breath and brain fog. Treatment for the events were not reported. The adverse event of practically fainted was assessed as medically significant. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events of numbness, tingling in right hand, fatigued, practically fainted, feels weak, itchiness, soreness, shortness of breath, brain fog was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
70 2021-03-30 blood clot Her leg started bothering her, the pain was quite heavy and consistent; pain under her left arm; blo... Read more
Her leg started bothering her, the pain was quite heavy and consistent; pain under her left arm; blood cloth in her leg; a little nauseous; headache; tired; pins; A spontaneous report was received from a consumer concerning a female patient of 70-years-old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Pins/ Paraesthesia,nausea,tiredness,headache,pain in leg was quite heavy and consistent, blood cloth in leg, pain under left arm. The patients medical history was not provided .Concomitant medications reported included Eliquis starter pack twice a day,Latanoprost for Glaucoma,Omeprazole for heart burn. On 15 Jan 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 037K20A) vaccine via unknown route for prophylaxis of COVID-19 infection. On 12 Feb 2021,prior to the onset of events, the Patient received their second of two planned dose of mRNA-1273(Lot number: 024M20A) vaccine via unknown route for prophylaxis of COVID-19 infection On 12 feb 2021,That evening she got pins again.The next day she was a little nauseous, tired and had a headache. Her leg started bothering her 3 days to a week after the second dose.And the pain in her leg was quite heavy and consistent, she thought it might be her sciatica. She went to the doctor and ended up getting a doppler and they discovered a blood clott there. She had never had a blood clott before in her life.she was feeling pain under her left arm as well. No Treatment for the event was provided. Action taken with the mRNA-1273 in response to the event was not applicable. the event pins were considered resolved on 13 Feb 2021. The events nauseous,tiredness,headache were considered resolved on 14 Feb 2021. The outcome of the events pain in leg was quite heavy and consistent, blood cloth in leg, pain under left arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
70 2021-03-31 excessive bleeding She bled down her arm like she never bled before; Warm to touch; Tender to touch; Red warm 3inches r... Read more
She bled down her arm like she never bled before; Warm to touch; Tender to touch; Red warm 3inches round under the skin; Rash; Pain in arm; This spontaneous case was reported by a 70-years-old female consumer who received first dose of mRNA-1273 and experienced event rash. The consumer's medical history was not provided. Relevant concomitant medication was reported as acetylsalicylic acid (aspirin) for an unknown indication. On 14-JAN-2021, prior to the onset of the events the consumer received first of two planned doses of mRNA-1273 (batch number: 041L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 23-Jan-2021, the consumer experienced the event rash. Treatment information was not provided. The action taken with mRNA-1273 in response to the event was unknown. The outcome of event was unknown. The follow-up was received on 27-Jan-2021 and it included that the consumer had experienced events she bled down her arm like she never bled before, pain in arm, red warm 3inches round under the skin, warm to touch and tender to touch. On an unknown date, the consumer experienced the event she bled down her arm like she never bled before. On 14-JAN-2021, the consumer experienced the event pain in arm. On 23-Jan-2021, the consumer experienced the events red warm 3inches round under the skin, warm to touch and tender to touch. Treatment information was not provided. The action taken with mRNA-1273 in response to the events was unknown. The outcome of events was unknown. The follow up information was received on 27 Jan 2021. The outcome of rash (unknown), erythema and pain (recovered) of extremity was updated.; Reporter's Comments: This case concerns a 70 Y/O F with a serious unexpected event of hemorrhage, and nonserious unexpected pain in extremity, feeling hot, tenderness, and expected erythema, rash. Event onset on Day 1 after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
70 2021-03-31 blood clot, coughing up blood Pt. states she started to spit blood approximately 12 hours after Covid 19 vaccines. It happened bo... Read more
Pt. states she started to spit blood approximately 12 hours after Covid 19 vaccines. It happened both times. 1st dose given on 2/25/21, reporting second dose from 3/25/21 because pt. sought ER care at . She states the blood was coming from throat area, not vomiting. She just spit out blood and blood clots. Dr. will send her to ENT to rule out lesion.
70 2021-04-01 chest pain Post vaccine - Anxious, exacerbated COPD, c/o chest pain. Evaluated with 12 point lead. Administered... Read more
Post vaccine - Anxious, exacerbated COPD, c/o chest pain. Evaluated with 12 point lead. Administered nitro w/relief. Transported to ER
70 2021-04-02 chest discomfort at 11:00 P.M. I went to sleep after receiving my shot and I had severe pounding in my chest. I took ... Read more
at 11:00 P.M. I went to sleep after receiving my shot and I had severe pounding in my chest. I took 2 Alprazolan .25 before it stopped. Iwas just aout ready to go to the hospital but it did stop. Then on on 3/9 I had pain in my left hip area. I looked and my upper thigh had a sever rash with what appeared to be welts . This lasted for about 1 week
70 2021-04-02 loss of consciousness After shot was received went to have breakfast and then to grocery store. Came home and put a few t... Read more
After shot was received went to have breakfast and then to grocery store. Came home and put a few things away and began to feel nauseous and a little dizzy so laid down. Needed to use bathroom so went into bathroom and became very dizzy. Attempted to make it back to bed and called for husband. Husband heard me yell and when he came to bedroom I was laying in floor passed out. He called paramedics and they came immediately. When I came to I had a feeling of extreme heat over my entire body and then broke out into a bad sweat (I was still lying in floor). After that I had a feeling of extreme heat (like fire) in my feet that rushed up to my calves. Paramedics checked me out and during that time I had I believe 2 more episodes of the heat and sweat. Paramedics stayed for maybe 20 minutes and I seemed to be okay. I did not go to ER. Remainder of Thursday I was dizzy when I got out of bed. Dizziness improved on Friday and was better by Friday evening. Still some dizziness today (Saturday 4/3) when I move around but not bad. Blood pressure has sometimes been a little low (105/68) but sometimes more normal (118/70).
70 2021-04-02 palpitations headache around 3p, went to bed at 8p couldn't sleep due to heart racing then pain in back, arms , h... Read more
headache around 3p, went to bed at 8p couldn't sleep due to heart racing then pain in back, arms , had to urinate 5 times during night, still unable to sleep . got up 8am took tylenol for pain, valium to sleep, slept till 330pm. .2nd day still headache and all over body ache. foggy
70 2021-04-03 heart rate increased SHORT OF BREATH, FAST HEART RATE, COUGH, BODY ACHES BAD, HIGH FEVER, FATIGUE. TOOK IBUPROFEN AND AL... Read more
SHORT OF BREATH, FAST HEART RATE, COUGH, BODY ACHES BAD, HIGH FEVER, FATIGUE. TOOK IBUPROFEN AND ALKA SELTER PLUS FOR SINUS AND COLD. LASTED ABOUT 30 HOURS. PRAYED TO GOD TO HEAL ME.
70 2021-04-04 chest pain After 1 week my arm started swelling again & painful. I had temp of 99.5, Back ache, and chest ac... Read more
After 1 week my arm started swelling again & painful. I had temp of 99.5, Back ache, and chest ache when I breathed in. Fatigue. I took Naproxim Sodium for pain. Iced the area. Arm continues to be a little swollen with mild pain as of today. Will report this to my PC tomorrow.
70 2021-04-04 nosebleed 1. Headache began with 10 minutes and has lasted every day since March 9th, sometimes requiring mult... Read more
1. Headache began with 10 minutes and has lasted every day since March 9th, sometimes requiring multiple doses of Tylenol or injections of Toradol at night to relive severe pain. Today is April 5th and the headaches still persist. The headaches usually felt like a power drill going through both temples. I am NOT headache prone. Other headaches radiated from my shoulders up over my head and down the other side of my head. My shoulders and upper back ached and still does as of today. 2. Sinuses blocked within 20 minutes. Regular allergy drainage due to allergies has intensified and has not been controlled by Zyrtec or any other allergy medication. 3. The upper soft pallet in my mouth was swelled and sore for more than 2 weeks. it often bled when I swallowed. 4. I have frequent nosebleeds and sinus pressure. 5, The fatigue is CRUSHING. It is sometimes so horrid that I cannot do anything and this is unacceptable because I am an online professor and work full time +. I cannot afford not to work!! 6. I had nearly 2 weeks of spiking fevers of about 99-100. The fever spikes would last between 5 and 10 minutes. I know these were not "hot flashes" because I am long past that and am on controlled HRT. 7. The newest side effect is frequent brain fog. This has started in the past 10 days and is very disconcerting and is probably related to the excessive fatigue. I have spoken with a nurse in my doctor's office and she stated that nobody else she has spoken to has had any of these side effects. I just keep moving on and hope these do not get worse with the second shot, As of today, April 5th, these
70 2021-04-04 fainting Body Aches, chills followed by fever which progressed to 102.4, Became faint with vomiting. At 3... Read more
Body Aches, chills followed by fever which progressed to 102.4, Became faint with vomiting. At 32 hours developed red rash at injection site (pain and itching)
70 2021-04-04 fainting fainted, fell off chair onto floor.
70 2021-04-04 fainting Patient developed fever of 101.3, body aches and had a 5 second syncopal episode then vomiting the d... Read more
Patient developed fever of 101.3, body aches and had a 5 second syncopal episode then vomiting the day of the vaccine
70 2021-04-04 troponin increased Patient admitted with encephalopathy, rhabdomyolysis, lactic acidosis, troponin elevation. Note the... Read more
Patient admitted with encephalopathy, rhabdomyolysis, lactic acidosis, troponin elevation. Note the presence of other medications, ie ambien and neurontin that may have contributed to her illness
70 2021-04-05 haemoglobin decreased 4/4/21 ER HPI: 70 y.o. female who presents with complaint of weakness, shortness of breath worse wit... Read more
4/4/21 ER HPI: 70 y.o. female who presents with complaint of weakness, shortness of breath worse with exertion the started this morning. Patient was said to be fine yesterday. Patient denies chest pain, nausea vomiting or abdominal pain, no headache or dizziness. Patient is also said to have pale conjunctiva. No fever or chills and no cough. triage note: Patient presents to er with daughter from home with complaints of increased weakness, increased shortness of breath. States upon waking today daughter states "she was more confused and more difficulty with ambulation. States she was off balance today with stumbling more than normal. Daughter states she was "verbally exhausted today." Patient unable to answer questions.
70 2021-04-06 cerebrovascular accident, ischaemic stroke She was admitted at hospital on 3/9/21-3/11/21 due to ischemic stroke which she received TPA and mec... Read more
She was admitted at hospital on 3/9/21-3/11/21 due to ischemic stroke which she received TPA and mechanical thrombectomy for L MCA M1 occlusion. Her symptoms include aphasia, R facial droop, R side weakness. Patient report no residual deficits.
70 2021-04-06 low blood oxigenation Patient presented to our emergency department on 3/21 with COVID pneumonia. Patient was treated wi... Read more
Patient presented to our emergency department on 3/21 with COVID pneumonia. Patient was treated with antibiotics and dexamethasone but was not a candidate for remdesivir. Hospital course was prolonged due to hypoxia requiring oxygen. Patient discharged to home with oxygen to use during exertion.
70 2021-04-06 loss of consciousness Patient passed out 24 hours after vaccination. Dose 2 of Moderna. She has recovered from the event a... Read more
Patient passed out 24 hours after vaccination. Dose 2 of Moderna. She has recovered from the event and no additional treatment was necessary.
70 2021-04-06 fainting I felt dizzy and lightheaded stepping out of the shower ( March 20, 2021 at around 10:00 am) and I f... Read more
I felt dizzy and lightheaded stepping out of the shower ( March 20, 2021 at around 10:00 am) and I fainted and landed on the floor. When I came to, I was able to use the toilet to pull myself up and sit on the toilet seat until I got back in control of myself. I was lucky- I only had a few black and blue marks on my right knee, but it had potential to be serious- head injuries etc. I am 70 years old and this is the only time in my life that I have fainted. Very scary and has caused some emotional stress for me.
70 2021-04-07 cerebrovascular accident, blood clot Blood clot (brain)/ stroke
70 2021-04-07 chest pain severe Asthma Attack, wheezing , shortness of breath, coughng chest pain extreme weakness / feeling ... Read more
severe Asthma Attack, wheezing , shortness of breath, coughng chest pain extreme weakness / feeling like i were about to pass out ended up in a steroid , used my inhaler and utilized a nebulizer for over a month
70 2021-04-07 heart attack, pallor, blood glucose increased She felt. Ad the evening of her 2nd vaccine. The morning after she felt worse. Nauseous, pale, ach... Read more
She felt. Ad the evening of her 2nd vaccine. The morning after she felt worse. Nauseous, pale, achy. She said she had not ever felt that bad. I read possible side effects. It said flu like symptoms, so we thought it would pass. Then around 4 she called for me & when I got there she had an event that caused her to be unable to speak & her eyes widened & pupils were dilated. I called 911. They got here quick. She had at least three of those stiffening wide eyed events. The emt said they thought it was her blood sugar. When checked it was 350 even though she had taken her insulin that day. They said she had a massive heart attack on the way to the hospital.
70 2021-04-08 ischaemic stroke, atrial fibrillation I received 1st Covid shot on Feb 18, 2021. On March 4,2021, I was taken to Med Center by ambulance a... Read more
I received 1st Covid shot on Feb 18, 2021. On March 4,2021, I was taken to Med Center by ambulance after having a small stroke that am. I don't know if there is any correlation? Did not think so, as I received my second Covid shot on March 18th, without any adverse reaction at all. I am only sending this o you as I wws informed that you would want to know about this?
70 2021-04-08 heart attack, heart rate increased, palpitations, heart flutter, atrial fibrillation Heart beat of 200 bpm; Heart attack; Flu like symptoms; frequent urination; Dry heaves; Heart flutte... Read more
Heart beat of 200 bpm; Heart attack; Flu like symptoms; frequent urination; Dry heaves; Heart fluttering; Atrial Fibrillation; fever; Little flutter; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Heart beat of 200 bpm), MYOCARDIAL INFARCTION (Heart attack) and ATRIAL FIBRILLATION (Atrial Fibrillation) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cardiac catheterisation (Found blockages which resulted in 2 stents.) on 17-Mar-2021. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PALPITATIONS (Little flutter). On an unknown date, the patient experienced HEART RATE INCREASED (Heart beat of 200 bpm) (seriousness criterion hospitalization), MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms), POLLAKIURIA (frequent urination), RETCHING (Dry heaves), CARDIAC FLUTTER (Heart fluttering), ATRIAL FIBRILLATION (Atrial Fibrillation) (seriousness criterion medically significant) and PYREXIA (fever). The patient was hospitalized on 16-Mar-2021 due to HEART RATE INCREASED. At the time of the report, HEART RATE INCREASED (Heart beat of 200 bpm), MYOCARDIAL INFARCTION (Heart attack), PALPITATIONS (Little flutter), INFLUENZA LIKE ILLNESS (Flu like symptoms), POLLAKIURIA (frequent urination), RETCHING (Dry heaves), CARDIAC FLUTTER (Heart fluttering), ATRIAL FIBRILLATION (Atrial Fibrillation) and PYREXIA (fever) outcome was unknown. Patient went to the hospital in an ambulance. Treatment information was not provided. On 26 Mar 2021, the patient had to wear holter monitor for 1 month for observation of atrial fibrillation. This case was linked to US-MODERNATX, INC.-MOD-2021-056770, US-MODERNATX, INC.-MOD-2021-056770 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities US-MODERNATX, INC.-MOD-2021-056770:1st Dose Case US-MODERNATX, INC.-MOD-2021-056770:2nd dose case
70 2021-04-08 lightheadedness April 8, 2021 Modern NDC #80777-273-99 Lot #031A21A Hx: COPD, Heart Disease, Stent to R kidney ... Read more
April 8, 2021 Modern NDC #80777-273-99 Lot #031A21A Hx: COPD, Heart Disease, Stent to R kidney 12:35 Patient received vaccine 12:40 Patient complained of ?hot? and dizzy with near syncopal event. Pt moved via wheelchair to bed. Placed in supine position with legs elevated. Pt kept repeating she had COPD. Respirations were rapid but no complaint of difficulty breathing. EMS notified. Vital signs: BP 136/82 HR 70 O2 sat 98% R 28 Pt sister, with patient at bedside. Sister stated she has a history of anxiety. 12:50 EMS arrived. Evaluated by EMS. Respirations improving. No longer feels hot and dizzy. 1:00 Patient signed refusal to transport with EMS 1:05 Patient sitting on side of bed. No s/s of distress. No shortness of breath or difficulty breathing. 1:15 Patient ambulated with assistance. 1:20 RN escorted pt to vehicle with sister driving and monitoring patient. 5:20 p.m. Follow up phone call with patient: No further issues. VAERS AND ARIA reports filed RN Infection Prevention and Control Health Dept
70 2021-04-09 chest pain 66 hours after vaccine given -- uncontrollable shivering, nausea, urgent need to poop, lighheadednes... Read more
66 hours after vaccine given -- uncontrollable shivering, nausea, urgent need to poop, lighheadedness, headache, heartburn, back ache, chest/lung pain.
70 2021-04-09 fainting, chest pain, fluid around the heart, inflammation of the pericardium Syncope while working in garden 3/28/21, ED visit, no imaging, EKG NSR, treated with IVF attributed ... Read more
Syncope while working in garden 3/28/21, ED visit, no imaging, EKG NSR, treated with IVF attributed to dehydration Severe neck pain radiating to chest started 4/2/21, CT showed large pericardial effusion, admitted to hospital for acute pericarditis with pericardial effusion
70 2021-04-10 palpitations Next day: chills/fever/splitting headache/extreme nausea/racing heart. The 24 hours I was sick, my F... Read more
Next day: chills/fever/splitting headache/extreme nausea/racing heart. The 24 hours I was sick, my Fitbit logged in 279 zone minutes (fat burning/cardio zones) but I was in bed all day. Normal RHR is 65-68; RHR after inoculation was 77 but trending down. 5 days post inoculation, RHR is 73.
70 2021-04-11 fast heart rate tachycardia detected during daily BP checks, starting 3-28-2021
70 2021-04-12 hypotension dehydration; temperature that I couldn't keep down; weak; difficulty breathing; spots on lungs; low ... Read more
dehydration; temperature that I couldn't keep down; weak; difficulty breathing; spots on lungs; low blood pressure; cracked 2 crowns and 3 crowns lost from clinching jaw; cracked 2 crowns and 3 crowns lost from clinching jaw; nausea/vomiting; body aches; muscle aches; rash; vomiting; Started on fluids and lungs filled up with fluid; pancreas was being attacked- pancreatitis; septic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY OEDEMA (Started on fluids and lungs filled up with fluid), PANCREATITIS (pancreas was being attacked- pancreatitis), SEPSIS (septic) and DEHYDRATION (dehydration) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (Started on fluids and lungs filled up with fluid) (seriousness criterion medically significant), PANCREATITIS (pancreas was being attacked- pancreatitis) (seriousness criterion medically significant), SEPSIS (septic) (seriousness criterion medically significant), DEHYDRATION (dehydration) (seriousness criterion hospitalization), BODY TEMPERATURE INCREASED (temperature that I couldn't keep down), ASTHENIA (weak), DYSPNOEA (difficulty breathing), PULMONARY MASS (spots on lungs), HYPOTENSION (low blood pressure), BRUXISM (cracked 2 crowns and 3 crowns lost from clinching jaw), TOOTH INJURY (cracked 2 crowns and 3 crowns lost from clinching jaw), NAUSEA (nausea/vomiting), PAIN (body aches), MYALGIA (muscle aches), RASH (rash) and VOMITING (vomiting). The patient was hospitalized from 20-Mar-2021 to 26-Mar-2021 due to DEHYDRATION. At the time of the report, PULMONARY OEDEMA (Started on fluids and lungs filled up with fluid), PANCREATITIS (pancreas was being attacked- pancreatitis), SEPSIS (septic), DEHYDRATION (dehydration), BODY TEMPERATURE INCREASED (temperature that I couldn't keep down), ASTHENIA (weak), DYSPNOEA (difficulty breathing), PULMONARY MASS (spots on lungs), HYPOTENSION (low blood pressure), BRUXISM (cracked 2 crowns and 3 crowns lost from clinching jaw), TOOTH INJURY (cracked 2 crowns and 3 crowns lost from clinching jaw), NAUSEA (nausea/vomiting), PAIN (body aches), MYALGIA (muscle aches), RASH (rash) and VOMITING (vomiting) outcome was unknown. No concomitant products included. Patient's treatment information include Advil, trigger point injections in neck, hot and cold packs, Lasix, antibiotics, pain meds, discharged from hospital on oxygen. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
70 2021-04-12 oxygen saturation decreased Bronchial tubes began to close up; Low oxygen levels to 83%; Swelling of face; hard time catching br... Read more
Bronchial tubes began to close up; Low oxygen levels to 83%; Swelling of face; hard time catching breath; terrible body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRONCHOSPASM (Bronchial tubes began to close up) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pulmonary disorder (Reported consulting pulmonologist ). Concomitant products included METOPROLOL, OXYCODONE and Nebulizer for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced BRONCHOSPASM (Bronchial tubes began to close up) (seriousness criterion medically significant), OXYGEN SATURATION DECREASED (Low oxygen levels to 83%), SWELLING FACE (Swelling of face), DYSPNOEA (hard time catching breath) and PAIN (terrible body ache). At the time of the report, BRONCHOSPASM (Bronchial tubes began to close up), OXYGEN SATURATION DECREASED (Low oxygen levels to 83%), SWELLING FACE (Swelling of face), DYSPNOEA (hard time catching breath) and PAIN (terrible body ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Oxygen saturation: 83 % (Low) Low. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications included prednisone and other medications. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
70 2021-04-12 lightheadedness Congestion in lungs; Upper respiratory infection; Felt passed out; This spontaneous case was reporte... Read more
Congestion in lungs; Upper respiratory infection; Felt passed out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY CONGESTION (Congestion in lungs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A24A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PULMONARY CONGESTION (Congestion in lungs) (seriousness criterion medically significant), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) and PRESYNCOPE (Felt passed out). At the time of the report, PULMONARY CONGESTION (Congestion in lungs), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) and PRESYNCOPE (Felt passed out) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Patient had fever, chills, headache and sore throat. Then later she developed cough with mucus and shortness of breath. She still had congestion in lungs and at one time almost felt passed out. She has been to emergency 4 times for this and they told her that it was upper respiratory infection. Treatment medications included Loratadine, Dexamethasone and Albuterol.
70 2021-04-12 pulmonary embolism Dose 1 was administered;10 days prior to dose 2 patient began to have shortness of breath. Dose 2 w... Read more
Dose 1 was administered;10 days prior to dose 2 patient began to have shortness of breath. Dose 2 was administered 3-23-21, Moderna Lot 006B21A. Severe sob and left sided pain 3-23-21 @ 5:30pm/difficulty moving around. Sought treatment at Hospital on 3-25-21 as symptoms were increasing in severity/chest xray and CT revealed pulmonary embolisms in both lungs; Heparin was started/transported by ambulance to another hospital for clot removal. Decided not to do procedure and was kept on Heparin for 24 hours. Began Eliquis that Friday/symptoms began to resolve and was dc'd on Saturday.
70 2021-04-12 blood clot What appeared to be blood clots on both forearms.
70 2021-04-12 transient ischaemic attack Distension, abdominal tenderness Medial visual field loss in left eye. Covid pneumonia, TIA suspecte... Read more
Distension, abdominal tenderness Medial visual field loss in left eye. Covid pneumonia, TIA suspected from Covid
70 2021-04-13 fainting, hypotension Pt developed severe hypotension and two episodes of syncope at onset of hypotension. Since that dat... Read more
Pt developed severe hypotension and two episodes of syncope at onset of hypotension. Since that date we have struggled to maintain her blood pressure over a systolic of 100. She frequently runs 75/55 sitting down. She is not orthostatic. Resting P has increased from 80 to 95. She is currently taking Droxidopa 400mg tid prn and Midodrine 10mg prn. Additionally, when these do not raise her systolic to 100, she takes 100 Hydrocortisone. The presumed diagnosis is dysautonomia, and she has been referred to a specialty center.
70 2021-04-14 haemoglobin decreased, ventricular tachycardia, stroke, troponin increased, cardiac arrest, heart failure Two days following first dose Moderna Vaccine at Pharmacy, she suffered a cardiac arrest. Below Di... Read more
Two days following first dose Moderna Vaccine at Pharmacy, she suffered a cardiac arrest. Below Discharge Summary From 3/26 hospital. Patient PCP Information Provider PCP Type DO General Discharge Summary by DO at 3/26/2021 12:42 PM Author: DO Service: Cardiology Author Type: Resident Filed: 3/26/2021 12:57 PM Date of Service: 3/26/2021 12:42 PM Status: Attested Editor: DO (Resident) Cosigner: MD at 3/26/2021 1:17 PM Resident Attestation: I personally saw and examined the patient on rounds with my cariology resident team on the day of the resident's note. Management was discussed with the cardiology resident and I supervised the plan of care. I have reviewed and agree with the key parts of the resident evaluation including: Subjective information Objective findings on physical exam Impression and plan Gen: appears comfortable, sitting in bed Resp: clear. no wheezes, rhonchi, rales CV: normal rate, regular, no m/r/g Abd: soft, nt/nd Ext: warm, no edema. Pressure ulcer boots on. Pleasant 70-year-old woman who had a history of PVCs, left bundle branch block, and a mild nonischemic cardiomyopathy, came into the hospital following a VT/VF cardiac arrest. Her echocardiogram done while in the hospital showed a preserved ejection fraction. Her cardiac catheterization showed normal coronary arteries. She had implantation of an ICD. Hospital course has been complicated by watershed cerebral infarcts. In addition, she had an episode of C. difficile colitis. She has gradually improved over the course of the past 3 weeks. From a cardiovascular perspective, she is being discharged on carvedilol 25 mg twice a day, lisinopril 10 mg daily, and her home atorvastatin. With regards to her etiology of cardiac arrest, I would be suspicious about the possibility of sarcoidosis. However, we were not able to get a cardiac MR while she was inpatient due to her strokes and inability to consistently follow commands and hold her breath. Would recommend consideration of an outpatient. She is ready to discharge to subacute rehab today. I have spent greater than 30 minutes in discharge planning. Preferred Name: PATIENT PCP: DO Primary Cardiologist: MD Discharging Cardiologist: MD Admission Date: 3/5/2021 Admission Diagnosis: Cardiac arrest Discharge Date: 03/26/21 Discharge Summary Author: DO Primary Discharge Diagnosis VT/VF cardiac arrest, s/p therapeutic hypothermia S/p AICD placement 3/16/2021 Secondary Discharge Diagnoses Anoxic brain injury, recovering, with persistent aphasia and dysphagia C. difficile colitis Non-sustained ventricular tachycardia, resolved DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness Patient is a 70 y.o. female, with history of nonischemic cardiomyopathy, admitted on 3/5/2021 after out of hospital VT/VF cardiac arrest. She completed therapeutic hypothermia protocol. Cardiac catheterization did not show any significant obstructive coronary disease. TTE showed LVEF 55%. Patient underwent AICD placement on 3/16/2021. Had some recurrent nonsustained ventricular tachycardia afterward, which resolved after increasing her carvedilol doses. Her course was complicated by a C. difficile infection, treated with PO Vancomycin, with significant improvement in diarrhea. She has had gradual neurologic recovery. Neurology felt she had had several watershed infarcts, but felt that she would continue to have a prolonged recovery over the next few months. Had some recovery of language/cognition prior to discharge. Due to her waxing/waning encephalopathy, she did not qualify for inpatient rehab, but will be discharged to subacute rehab. Discharged with tube feeding continued, though she can begin sips with speech therapy supervision. Patient seen and examined at bedside on the day of discharge. She stated that she had no pain, though HPI/ROS still limited due to aphasia. Discussed above information with patient's husband, who understood and was in agreement with the plan. Problem-Based Hospital Course NEURO Acute metabolic encephalopathy, with gradual recovery -Due to neurologic injury from cardiac arrest. -Neurology consult: concern for anoxic brain injury with watershed infarcts, anticipate very gradual recovery over the coming months. No acute process on imaging. -Patient extubated on 3/11, following some commands. Continuing to regain conversational ability and motor function gradually each day. Has some waxing and waning of mental status, but overall her encephalopathy continues to improve. -Limit centrally acting/sedating medications -Speech following for language/cognition as well as dysphagia requiring tube feeding. Can begin some sips in addition to tube feeds. -Continue tube feeds via tube per instructions provided on after visit summary INFECTIOUS DISEASE C. Difficile Colitis: -C.Diff Positive 3/18. Continue 125 mg PO Vancomycin Q6H for 10 days (3/18 - 3/27), confirmed with infectious disease -Frequency of diarrhea has decreased significantly, was stable after rectal tube removed 2-3 days prior to discharge Pneumonia, likely due to aspiration, resolved -s/p 5 day course ceftriaxone (3/5 - 3/9 ) -CTA on admission showed significant RUL and RLL consolidation with air bronchograms, as well as some patchy airspace disease in LUL -Had copious tan sputum on suctioning 3/7 - respiratory culture negative CARDIOLOGY Out of hospital cardiac arrest, likely VT/VF -Pt's husband initiated chest compressions x 10 minutes, until police/fire dept arrival, when AED showed a shockable rhythm. Likely VT/VF arrest. -S/p therapeutic hypothermia protocol. -Troponin peaked at 1.09 -3/16 Successful single chamber ICD implantation Nonsustained ventricular tachycardia (NSVT), resolved Chronic left bundle branch block -Has had multiple episodes of NSVT noted on telemetry 3/19 - 3/20 -s/p ICD as above -Increased dose of Carvedilol to 25 mg BID with resolution of NSVT History of nonischemic cardiomyopathy, LVEF 55% -Echo in 11/2019 demonstrated EF 42% (nadir). -TTE on admission showed recovered EF to 55%, mild concentric LVH, normal RV systolic function, no valvular abnormalities -Was initially started on aspirin/statin due to high suspicion for CAD, but as cardiac cath 3/15 was unremarkable, these medications were discontinued. -3/16 Successful single chamber ICD implantation Hypertension -Blood pressure now improved after restarting home lisinopril and initiating carvedilol -HCTZ discontinued as BP now well controlled on above regimen RENAL Oliguria, resolved -Pt initially had low urine output since admission, improved to 0.5 cc/kg/hr on 3/9. Continue fluids with free water flushes through tube feeds -Has had normal electrolytes, renal function, and urine output since initial renal recovery. RESPIRATORY Acute hypoxic respiratory failure secondary to cardiac arrest, s/p mechanical ventilation, extubated 3/11 -Patient successfully extubated 3/11, stable respiratory status. Protecting airway well. -Encourage incentive spirometry HEMATOLOGY Acute normocytic anemia, improving -Pt had Hgb drop from baseline around 13-14 at admission to 10.9, now around 10-11. -Has iron saturation of 11%. Normal LDH/bilirubin, ruling out hemolysis. -Started oral iron supplements -Consider outpatient screening for colon cancer ENDOCRINE Osteoporosis - on alendronate at home Discharge Disposition Discharge to skilled nursing facility Active Issues Requiring Follow-up Cardiology -follow-up for AICD placement PCP -post hospital follow-up Test Results Pending at Discharge -none
70 2021-04-14 palpitations Muscle spasms, pain on right hip joint All the way to the heel. Joints, muscle,, bones and tendons o... Read more
Muscle spasms, pain on right hip joint All the way to the heel. Joints, muscle,, bones and tendons on left sciatic nerve and muscle all the way to the middle of calf, extreme exhaustion , nauseousness for several days With fever. Fever of 100.7 for several days. these are symptoms from the first vaccine. Vaccine #2 - Pain on vaccine site with rash and itchiness for 10 days . much pain on the back of my left leg and pressure on the calf on the left Leg. Headache on top of head on left side going down to middle of nose on the left side of face. Strange flowing or dripping like sensation on the left side of my face only. Pain in my left leg. Dizzy, couldn?t walk and very had heart palpitations. Nauseous again.
70 2021-04-14 pulmonary embolism pt was vaccinated at 2pm on 4/13/2021 moderma vaccine lot 021b12a and on 4/14/2021 at 830 had sharp ... Read more
pt was vaccinated at 2pm on 4/13/2021 moderma vaccine lot 021b12a and on 4/14/2021 at 830 had sharp lung pain was sent to the hospital and was admitted with a PE
70 2021-04-15 heart rate increased a low functioning kidney; a low functioning liver; Little clumpies; black/brown raised and itchy; it... Read more
a low functioning kidney; a low functioning liver; Little clumpies; black/brown raised and itchy; itchy; Headache; Felt nauseated; experienced sickness; Unusual bowel movements- occurred approximately 5-6 times a day; Stool was cream/pale colour; Got really tired; appetite totally disappeared; Really fast heart beats; Blood pressure stayed 160 for a week, every day and night; This spontaneous case was reported by a patient and describes the occurrence of RENAL IMPAIRMENT (a low functioning kidney), HEPATIC FUNCTION ABNORMAL (a low functioning liver), DECREASED APPETITE (appetite totally disappeared), HEART RATE INCREASED (Really fast heart beats) and BLOOD PRESSURE ABNORMAL (Blood pressure stayed 160 for a week, every day and night) in a 70-year-old female patient who received Vaccine for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 05-Mar-2021, the patient received first dose (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DECREASED APPETITE (appetite totally disappeared), HEART RATE INCREASED (Really fast heart beats), BLOOD PRESSURE ABNORMAL (Blood pressure stayed 160 for a week, every day and night) and FATIGUE (Got really tired). On 06-Mar-2021, the patient experienced ILLNESS (experienced sickness), FREQUENT BOWEL MOVEMENTS (Unusual bowel movements- occurred approximately 5-6 times a day), FAECES DISCOLOURED (Stool was cream/pale colour), HEADACHE (Headache) and NAUSEA (Felt nauseated). On an unknown date, the patient experienced RENAL IMPAIRMENT (a low functioning kidney), HEPATIC FUNCTION ABNORMAL (a low functioning liver), SWELLING (Little clumpies; black/brown raised and itchy) and PRURITUS (itchy). At the time of the report, RENAL IMPAIRMENT (a low functioning kidney) and HEPATIC FUNCTION ABNORMAL (a low functioning liver) outcome was unknown and DECREASED APPETITE (appetite totally disappeared), HEART RATE INCREASED (Really fast heart beats), BLOOD PRESSURE ABNORMAL (Blood pressure stayed 160 for a week, every day and night), ILLNESS (experienced sickness), FREQUENT BOWEL MOVEMENTS (Unusual bowel movements- occurred approximately 5-6 times a day), FAECES DISCOLOURED (Stool was cream/pale colour), SWELLING (Little clumpies; black/brown raised and itchy), PRURITUS (itchy), HEADACHE (Headache), NAUSEA (Felt nauseated) and FATIGUE (Got really tired) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure systolic: 160 (abnormal) No diastolic reading. On an unknown date, Liver function test: low functioning (Low) Low Functioning. On an unknown date, Renal function test: low functioning (Low) Low Functioning. Treatment information was not provided. Concomitant medications were not reported. HCP advised, against receiving the second dose. Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.A causal relationship cannot be excluded for the events of fatigue, headache, pruritus and nausea.
70 2021-04-15 loss of consciousness Patient passed out the day after vaccine from standing height
70 2021-04-16 fibrin d dimer increased, pulmonary embolism This patient received her 2nd Moderna vaccine last week, w 10 days ago. She was seen in the ED today... Read more
This patient received her 2nd Moderna vaccine last week, w 10 days ago. She was seen in the ED today Submassive PE.
70 2021-04-18 blood glucose increased Extreme spike in blood glucose, 197 mg/dL 04/17/21(AM fasting) 235 mg/dL 04/18/21(AM fasting) Usual ... Read more
Extreme spike in blood glucose, 197 mg/dL 04/17/21(AM fasting) 235 mg/dL 04/18/21(AM fasting) Usual AM BG is 130 to 145 mg/dL BG read April 19 (today) is 139 mg/dL. Also experienced fatigue, arm pain and COVID arm for 5 days.
70 2021-04-19 pulmonary embolism Pulmonary embolism
70 2021-04-20 deep vein blood clot Extensive blood clot left leg
70 2021-04-21 chest pain, palpitations Chest Pain, Heart Palpitations Waking from Sleep, Shortness Breath, tight jaw, Indigestion, Nausea, ... Read more
Chest Pain, Heart Palpitations Waking from Sleep, Shortness Breath, tight jaw, Indigestion, Nausea, Short of Breath.
70 2021-04-21 chest pain Diagnosed with shingles; the rash is on my torso and in the back; I couldn't sleep at night; The pai... Read more
Diagnosed with shingles; the rash is on my torso and in the back; I couldn't sleep at night; The pain was excruciating; Discomfort pains in center of chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Discomfort pains in center of chest), CHEST PAIN (The pain was excruciating) and HERPES ZOSTER (Diagnosed with shingles) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (medical history was not reported.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced CHEST PAIN (Discomfort pains in center of chest) (seriousness criterion medically significant). On 27-Mar-2021, the patient experienced CHEST PAIN (The pain was excruciating) (seriousness criterion medically significant) and INSOMNIA (I couldn't sleep at night). On 28-Mar-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles) (seriousness criterion medically significant) and RASH (the rash is on my torso and in the back). At the time of the report, CHEST PAIN (Discomfort pains in center of chest), CHEST PAIN (The pain was excruciating), HERPES ZOSTER (Diagnosed with shingles), INSOMNIA (I couldn't sleep at night) and RASH (the rash is on my torso and in the back) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event included Famciclovir for 7 days initially and Acyclovir ointment for the Shingles rash and Celebrex for the pain. This case concerns a 70-year-old female with a serious unexpected event of chest pain and herpes zoster, and nonserious unexpected insomnia and rash. Event onset 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 70-year-old female with a serious unexpected event of chest pain and herpes zoster, and nonserious unexpected insomnia and rash. Event onset 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
70 2021-04-21 low blood oxigenation This patient received the Covid shot and has a primary coded discharge of U07.1 Covid-19. Please re... Read more
This patient received the Covid shot and has a primary coded discharge of U07.1 Covid-19. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation. Other diagnoses E87.6 - Hypokalemia R09.02 - Hypoxia R74.01 - Elevated transaminase level J18.9 - Multifocal pneumonia U07.1 - COVID-19
70 2021-04-21 ischaemic stroke Pt had hives day of vaccine 4/7. Transport to hospital on 4/8 for extremity weakness. Confirmed larg... Read more
Pt had hives day of vaccine 4/7. Transport to hospital on 4/8 for extremity weakness. Confirmed large vessel ischemic stroke.
70 2021-04-22 palpitations Severe heart palpitations; Fever; Chills; Tired; This spontaneous case was reported by a consumer an... Read more
Severe heart palpitations; Fever; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Severe heart palpitations) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tired). On 14-Apr-2021, the patient experienced PALPITATIONS (Severe heart palpitations) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 14-Apr-2021 due to PALPITATIONS. At the time of the report, PALPITATIONS (Severe heart palpitations) outcome was unknown and PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tired) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Angiogram: normal (normal) Normal. On 04-Mar-2021, Blood pressure measurement: (High) Increased. On 04-Mar-2021, Cardiac stress test: normal (normal) Normal. On 04-Mar-2021, Electrocardiogram: normal (normal) Normal. On 04-Mar-2021, Heart rate: elevated and (High) Increased. On 04-Mar-2021, Magnetic resonance imaging: normal (normal) Normal. In April 2021, Blood pressure measurement: (High) Elevated. In April 2021, Heart rate: elevated High. Comments from the patient: Yesterday 14APR2021 I had severe Heart Palpitations and I was taken to the Hospital. I called an ambulance and they brought me to the Emergency Room. The Doctor performed an EKG and my heart was in normal condition. I received my second Moderna Covid-19 vaccination on 3MAR2021.By 5PM on 3MAR2021 I had a Fever, Chills, was tired, I woke up at 6AM on 4MAR2021 with an elevated Heart Rate and elevated Blood Pressure. I went to go see my Cardiologist that day and he sent me right to the Hospital. I spent 2 days and 1 night in the Hospital. MRI, MRA, Stress Test, EKG were performed and all tests were normal. I was discharged from the Hospital on 6MAR2021. Then I came home and was fine until early April when my elevated heart beat, elevated blood pressure, and heart palpitations started again. My Cardiologist started me on Diltiazem 30mg three times per day. Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. This case was linked; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Crossinked with First dose case
70 2021-04-25 deep vein blood clot DVT Right leg I82.431
70 2021-04-27 hypertension Patient had swollen left arm after injection with second vaccine. Patient received first vaccine at ... Read more
Patient had swollen left arm after injection with second vaccine. Patient received first vaccine at mass clinic. She had similar reaction about 24 hours after her first dose on 3/4/2021. She said it went away and about 10 days later came back. She chose to get her second dose at the pharmacy in case it happened again. The patients arm was swollen and red at injection site and down to above her elbow. We placed ice on it immediately after patient noticed swelling and redness. After about five minutes it appeared to be getting worse. I moved the patient to a private area and administered diphenydramine 12.5mg/ml at a dose of 50mg. Her husband agreed to drive her home and was present for the entire exchange. She complained she was feeling a bit anxious and I took her blood pressure at 12:11pm it read 194/97 her pulse was 74. Her O2 sat was at 99. I had her stay seated and drink some water. We went through some breathing exercises and I brought another pharmacist over to talk to her and keep her distracted while I got her a granola bar. I checker her blood pressure again at 12:45pm and it had dropped to 175/93 with a pulse of 72. The swelling and redness in her arm also went down significantly. I told the patient I would check again in 15 minutes if her bp continued to drop and pulse was good I would let them go. She had calmed down a lot at this point and was felling much better. There was only slight redness, which also could have been from the cold ice pack still applied to her arm. At 12:59pm her bp was 164/92 and pulse read 66. The patient agreed to contact me if there were any other issues. They were going to eat at the restaurant next door and check in afterwards if her arm started to swell again. They purchased diphenhydramine and I advised on how to dose. I advised patient to get lots of rest and stay hydrated.
70 2021-04-27 transient ischaemic attack The Thursday after the shot, patient had a TIA.
70 2021-04-29 chest pain Patient received her second dose of moderna on 4-22-21. On 4-25-21, patient states she began to exp... Read more
Patient received her second dose of moderna on 4-22-21. On 4-25-21, patient states she began to experience chest pain when she took deep breaths. On 4-28-21, patient states she went to the emergency room. She states the hospital did a chest x-ray, a scan, and a heart echo. She was diagnosed with a lung clot. Patient states she was put on a blood thinner. On 4-29-21, the patient was discharged with a prescription of Eliquis.
70 2021-04-30 hypertension Left lateral gaze palsy and/or diplopia
70 2021-05-02 pulmonary embolism Submassive PE 5-6 weeks after the 2nd dose of COVID Moderna vaccine, no other pre-disposing factors ... Read more
Submassive PE 5-6 weeks after the 2nd dose of COVID Moderna vaccine, no other pre-disposing factors other than hx of DVT after a surgery.
70 2021-05-02 pulmonary embolism Pulmonary Embolism in lower left lung treated with Elaquis and increased statin
70 2021-05-03 brain sinus blood clot Venous sinus thrombosis
70 2021-05-03 chest pain I had a "drop attack: on 3/8/21. suddenly went limp and fell to the ground, conscious, but not dizz... Read more
I had a "drop attack: on 3/8/21. suddenly went limp and fell to the ground, conscious, but not dizzy in advance. When comfortable, I walked into another room to get my BP cuff, and the same thing happened. I fell limp to the ground, unhurt. Then unable to get up because limbs felt like spaghetti for about an hour. I had a PET scan which was unremarkable on 4/9/21, with some hypoperfusion neurophalm exam unremarkable 4/16 3rd attack, falling backwards, unharmed 4/24 sudden transientbinocular diplopia.. 4/30 a cardiac loop placed. Afterwards, BP 180/98 and transient aphasia. Followed by chest pain. Hosp overnight. MI r/o.
70 2021-05-04 stroke, cerebrovascular accident Patient was immunized with the second Moderna vaccine in the left arm (not in this clinic) on 04/16/... Read more
Patient was immunized with the second Moderna vaccine in the left arm (not in this clinic) on 04/16/21. ON 04/27/21 she suffered a CVA. She is now being treated with statin and plavix
70 2021-05-05 hypertension, blood pressure increased On Mar 15 in the evening, patient developed left sided numbness initially in the chest, and then wok... Read more
On Mar 15 in the evening, patient developed left sided numbness initially in the chest, and then woke up the morning of Mar 16 with numbness on the left side of her face, left arm, and left leg. She also complained of a frontal headache that felt like a sinus infection. She went to the ER at 10am at Hospital. CT brain and CT angio head/neck were negative. MRI brain w/o contrast showed no stroke and MRI cervical w/o contrast showed mild cervical arthrosis. She had gradual improvement in her numbness. ECHO showed mild LVH, no shunt or PFO. She was started on lisinopril due to mildly elevated blood pressures during this admission- new diagnosis of hypertension. After discharge she continued to have episodes of left sided numbness and blurry vision nearly every day until she presented to my clinic to establish care on 04/22. At that time she was experiencing numbness on the left side of her face in a V2 distribution. She was sent to the ER at Medical Center and was admitted 4/22- 4/24. CT head was negative. Symptoms resolved after this hospitalization. MRI/MRV was ordered outpatient and performed 05/04. MRV showed Right transverse venous sinus filling defect probable thrombus, nonocclusive. She was started on Pradaxa 05/05 and has not had any neurologic symptoms since.
70 2021-05-06 heart flutter, palpitations After vaccine was administered patient received heart racing and fluttering. Patient was seen by doc... Read more
After vaccine was administered patient received heart racing and fluttering. Patient was seen by doctor and instructed to wear a heart monitor. Doctor then had patient report to the emergency department after reviewing heart monitor data. Patient was admitted to the hospital and started on a beta blocker.
70 2021-05-06 loss of consciousness went unconscious for about 15 minutes. called 911, by the time the ambulance got there she was respo... Read more
went unconscious for about 15 minutes. called 911, by the time the ambulance got there she was responsive. went to hospital to get checked.
70 2021-05-07 loss of consciousness, excessive bleeding I lost consciousness shortly after getting up at 6:00 AM on 3/13/2021. I hit my head on a metal draw... Read more
I lost consciousness shortly after getting up at 6:00 AM on 3/13/2021. I hit my head on a metal drawer handle. Since I was bleeding from the back of my head (behind ear) and disoriented, my husband called 911. EM personnel determined I was amnesic and needed medical care. I was taken to the emergency room. The 2.5 cm laceration on my head needed 8 staples to suture it. I spent two night at the hospital, had a series of lab tests and received X-ray chest, CT cervical spine, transthoracic echocardiogram and EEG. I suffered no broken bones. This event occurred after I had received my second dose of the Moderna COVID 19 vaccine the day before.
70 2021-05-07 blood clot, transient ischaemic attack Amnesia; Cardiac disorder; Thrombosis; Transient ischaemic attack; This case was received via anothe... Read more
Amnesia; Cardiac disorder; Thrombosis; Transient ischaemic attack; This case was received via another Manufacturer (Reference number: vsafe) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of AMNESIA (Amnesia), CARDIAC DISORDER (Cardiac disorder), THROMBOSIS (Thrombosis) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The patient's past medical history included Glaucoma and Hypothyroidism. Concurrent medical conditions included Stroke. Concomitant products included LEVOTHYROXINE, BRIMONIDINE, LATANOPROST and TIMOLOL for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced AMNESIA (Amnesia) (seriousness criterion hospitalization), CARDIAC DISORDER (Cardiac disorder) (seriousness criterion hospitalization), THROMBOSIS (Thrombosis) (seriousness criteria hospitalization and medically significant) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) (seriousness criteria hospitalization and medically significant). At the time of the report, AMNESIA (Amnesia), CARDIAC DISORDER (Cardiac disorder), THROMBOSIS (Thrombosis) and TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Catheterisation cardiac: inconclusive. On 14-Jan-2021, Echocardiogram: inconclusive. On 14-Jan-2021, Magnetic resonance imaging: inconclusive. On 14-Jan-2021, Ultrasound scan: inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The next day, the patient had short term memory loss, patient went to the hospital, and they said patient had some type of heart episode. The patient was taken by ambulance to the hospital and was told had a blood clot in brain and had suffered a mini stroke. The patient was hospitalized for 4 nights. The patient was given blood thinner and got improved. Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded. However patient had an underlying risk in the past history of stroke.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded. However patient had an underlying risk in the past history of stroke.
70 2021-05-09 transient ischaemic attack, fainting Pt reported that she fainted after getting her COVID 19 vaccine (she did not know the manufacturer, ... Read more
Pt reported that she fainted after getting her COVID 19 vaccine (she did not know the manufacturer, nor has a lot #). She also stated that when she went to the hospital she was told that she had "multiple mini-strokes" She also tested positive to COVID 19 and required treatment.
70 2021-05-11 chest discomfort Patient stated feeling faint, complaints chest tightness, weakness, slumped in chair, clammy skin w... Read more
Patient stated feeling faint, complaints chest tightness, weakness, slumped in chair, clammy skin warm to touch, was verbal, patient aware of own name and location.
70 2021-05-12 fast heart rate Tachycardia, metallic taste, warm flushing. Waited 5 minutes before alerted nurse, by the time she a... Read more
Tachycardia, metallic taste, warm flushing. Waited 5 minutes before alerted nurse, by the time she arrived heart rate had slowed to 98. Physician checked BP it was OK. Waited an extra half hour before leaving.
70 2021-05-13 nosebleed Bloody nose after eating Dizziness Off balance Coughing Slight difficulty breathing
70 2021-05-13 pulmonary embolism, blood clot Blood Cloots in legs and lungs. Sweeling legs, couldn't breathe. Hospital and drugs. Still contin... Read more
Blood Cloots in legs and lungs. Sweeling legs, couldn't breathe. Hospital and drugs. Still continiting treatment.
70 2021-05-14 fainting Collapsed. Woke up to use bathroom & as I was returning to bed, I felt as if I was heavily drugged &... Read more
Collapsed. Woke up to use bathroom & as I was returning to bed, I felt as if I was heavily drugged & hanging onto the wall I finally collapsed banging my head on the wall. I was helped by my husband to get back into bed. He had me drink lots of water. I eventually fell back to sleep & felt fine when I woke up.
70 2021-05-17 blood pressure increased, palpitations Face swelling. Elevated BP 160/100 pulse 110 Constant Palpitations. Couldn?t catch breath Nauseous. ... Read more
Face swelling. Elevated BP 160/100 pulse 110 Constant Palpitations. Couldn?t catch breath Nauseous. Metal taste in Mouth At Medical facility 8:50 am till 7:00 PM Palpitations continued for 10 days I wear a loop record and constantly recorded incidents
70 2021-05-18 blood clot Blood clot in right calf
70 2021-05-20 chest discomfort, palpitations Patient presents to the ED complaining of chest tightness over last 2 days. Also noted racing heart... Read more
Patient presents to the ED complaining of chest tightness over last 2 days. Also noted racing heart rate and extremity tremors while walking up her stairs. Episode lasted for 2 minutes, continued to have these short episodes. Pain went away when lying down. Also felt back pain and nausea. No SOB or dizziness. Patient suspected of having unstable angina, with known CAD status. Patient was asymptomatic upon discharge.
70 2021-05-20 loss of consciousness After the vaccination, the patient was directed to our waiting area and sat down in a waiting chair ... Read more
After the vaccination, the patient was directed to our waiting area and sat down in a waiting chair (which does have arms). After <5 minutes, patient passed out and fell face forward out of the chair onto the floor. She hit her head and was unconscious. We ran to assist her, after about 15 seconds she came to, but was in and out of consciousness. She developed a baseball sized hematoma on her forehead and was sweating profusely. We called 911 and got the AED machine. She then passed out again and threw up, so we placed her on her side. We monitored her closely and kept her conscious until the paramedics arrived. By the time they arrived, she did not have recollection of the event but was alert. They transported her to the hospital.
70 2021-05-21 deep vein blood clot Patient received Moderna Covid Vaccine on 01/25/2021 and second Moderna COVID vaccine on 02/22/2021 ... Read more
Patient received Moderna Covid Vaccine on 01/25/2021 and second Moderna COVID vaccine on 02/22/2021 and was diagnosed with a left lower extremity deep vein thrombosis on 04/22/2021, patient was then subsequently admitted to the hospital on 05/05/2021 with acute on chronic respiratory failure and bilateral pneumonia requiring IV antibiotics and increased supplemental oxygen.
70 2021-05-27 chest discomfort, chest pain, hypertension Blood clot in lung diagnosed, worry related to blood thinner use; Chest pains; Chest "didn't feel ri... Read more
Blood clot in lung diagnosed, worry related to blood thinner use; Chest pains; Chest "didn't feel right"; Blood pressure increased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY THROMBOSIS (Blood clot in lung diagnosed, worry related to blood thinner use), CHEST PAIN (Chest pains) and CHEST DISCOMFORT (Chest "didn't feel right") in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Cholesterol blood excessive, Hypertension and Hyperlipidemia. Concomitant products included APIXABAN (ELIQUIS), CELECOXIB (CELEBREX), METOPROLOL SUCCINATE and LOSARTAN POTASSIUM for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST DISCOMFORT (Chest "didn't feel right") (seriousness criterion hospitalization). On 28-Apr-2021, the patient experienced PULMONARY THROMBOSIS (Blood clot in lung diagnosed, worry related to blood thinner use) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (Chest pains) (seriousness criterion hospitalization) and HYPERTENSION (Blood pressure increased). The patient was hospitalized on 28-Apr-2021 due to CHEST PAIN and PULMONARY THROMBOSIS. At the time of the report, PULMONARY THROMBOSIS (Blood clot in lung diagnosed, worry related to blood thinner use), CHEST PAIN (Chest pains), CHEST DISCOMFORT (Chest "didn't feel right") and HYPERTENSION (Blood pressure increased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Blood pressure measurement: increased (High) Increased. Concomitant medication included high cholesterol drug. On 28 Apr 2021, post second dose of vaccination patient experienced chest pains and went to emergency room. Patient reports a chest scan, chest X-ray, bloodwork, EKG, echocardiogram, and various tests were performed at the hospital. Patient was diagnosed with a blood clot in lungs. Patient reports being hospitalized several days and doctors indicated "she dodged a bullet". Patient reports the treating physicians could not determine the cause of the clot, nor determine if it was vaccine related. Patient reports concomitant medication, losartan dose was recently increased from 50mg to 100mg once daily. Patient attributes that the increased blood pressure was the worry related to being placed on blood thinners [Eliquis]. Treatment information included eliquis. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-138094 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
70 2021-05-27 hypertension HEADACHE & HTN REQUIRING EMERGENCY ROOM VISIT AT APPROX 9PM, 5/26/21. NEGATIVE CT OF BRAIN. UNKNOW... Read more
HEADACHE & HTN REQUIRING EMERGENCY ROOM VISIT AT APPROX 9PM, 5/26/21. NEGATIVE CT OF BRAIN. UNKNOWN IF ANY TREATMENT WAS ADMINISTERED AT THE ER. RESIDENT WAS RETURNED TO NURSING HOME AT APPROX 1AM ON 5/27/21 WITH NO DISTRESS NOTED.
70 2021-05-28 pulmonary embolism Severe breathing issue. Rattling in chest. urgent care on 4/6 and 4/10; enhalers issued, prednison... Read more
Severe breathing issue. Rattling in chest. urgent care on 4/6 and 4/10; enhalers issued, prednisone taken, shot of antibiotic given, chest x-ray. I flew in to home on 5/1. On 5/3 started having difficulty breathing progressively got worse went to nurse practioner on Friday, 5/7 sent to diagnostic imaging for ct scan with contrast found bilateral blood clots in lungs. Sent to ER at Hospital. Spent 4 days in hospital. Put on heparin until I was released on Monday. Put on eliquis when I was released on 5/10. See hematologist on June 1.
70 2021-05-28 cardiac arrhythmia, increased heart rate Sinus tachycardia with multiple PVCS
70 2021-05-31 oxygen saturation decreased Within 15 mins, I felt a tracheal restriction. I told the nurse I was having a hard time breathing. ... Read more
Within 15 mins, I felt a tracheal restriction. I told the nurse I was having a hard time breathing. She did my O2 stats and she said it had decreased to 92. I was given benadryll. They kept me for an additional half hour. A total of an hour. My arm hurt all day and into the next. It felt that way for 2-3 days. I did not run a fever. I took tylenol that night. I did not have a rash. These symptoms resolved in about 2 days.
70 2021-05-31 pulmonary embolism Patient was admitted to hospital 3 days after receiving vaccine, on 5/9/21. She initially presented... Read more
Patient was admitted to hospital 3 days after receiving vaccine, on 5/9/21. She initially presented with a headache and was later diagnosed with an acute PE without acute cor pulmonale, unspecified pulomonary embolism.
70 2021-06-01 heart rate increased, palpitations Blood pressure through the roof 185/125; heart racing; Pulse rate increased; This spontaneous case w... Read more
Blood pressure through the roof 185/125; heart racing; Pulse rate increased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALIGNANT HYPERTENSION (Blood pressure through the roof 185/125) and PALPITATIONS (heart racing) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Breast cancer, Palpitations (Heart palpitations), Blood pressure high and High cholesterol. Concomitant products included LOSARTAN for Blood pressure management, TAMOXIFEN for Breast cancer, PRAVASTATIN for Cholesterol, METOPROLOL for Palpitations, LEVOTHYROXINE for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced MALIGNANT HYPERTENSION (Blood pressure through the roof 185/125) (seriousness criteria hospitalization and medically significant), PALPITATIONS (heart racing) (seriousness criterion hospitalization) and HEART RATE INCREASED (Pulse rate increased). The patient was hospitalized on 14-Jan-2021 due to MALIGNANT HYPERTENSION and PALPITATIONS. On 14-Jan-2021, MALIGNANT HYPERTENSION (Blood pressure through the roof 185/125), PALPITATIONS (heart racing) and HEART RATE INCREASED (Pulse rate increased) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood pressure measurement: 185/125 (High) Blood pressure through the roof 185/125. On 14-Jan-2021, Heart rate: 150 (High) Pulse 150. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. The Patient reported that about 3 minutes post receiving her first dose of vaccine her heart was racing and blood pressure was through the roof (185/125). The patient also had an elevated pulse rate of 150. The patient reported that the symptoms subsided after 15 to 20 minutes and was feeling better however the patient was still taken to the Emergency Room.. The Centers for Disease Control suggested to the patient that she not receive her second dose of the vaccine. No treatment was provided to the patient in the emergency room. The patient had an Electrocardiogram (EKG) test completed but no results were provided. Company comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's past medical history may remain a contributing factors for this event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's past medical history may remain a contributing factors for this event.
70 2021-06-01 blood clot, hypertension I woke up and 1/2 my mouth and my tongue felt numb and tingling as if I had Novocain and it was wear... Read more
I woke up and 1/2 my mouth and my tongue felt numb and tingling as if I had Novocain and it was wearing off. Woke up the next day and it was still there so I called the NP. She said to go and get a CAT scan in the morning and it didn't show anything. Later in the afternoon I noticed I was dropping things and dragging my feet and got concerned it was a stroke so I drove down to a larger medical center and they did a contrast CAT scan and that showed nothing. So then they did an MRI and they found a clot. So they put me on Plavix, blood thinner and all that stuff. After a couple of days my hand and foot were fine but the numbness and tingling in my mouth is still there till now. All of this wasn't real pronounced so I didn't think it was a stroke but it was. They sent me to a Neurologist and Cardiologist.
70 2021-06-02 loss of consciousness After receiving the first vaccine my right arm was extremely sore and painful. Then after taking my ... Read more
After receiving the first vaccine my right arm was extremely sore and painful. Then after taking my second shot on March 10 my arm was still sore and painful. On March 11 I passed out after taking my allergy medicine, mometasone. I am still suffering from these side effects. The first shot was not given properly in my arm. Not in the muscle. The orthopedic refered me to see a physical therapist. I have been seeing the pt from March to the present. I am restricted from doing many things that I did before the shot.
70 2021-06-03 chest pain She got her vaccine, she had no reactions from the vaccine. She took Arnica before and after the va... Read more
She got her vaccine, she had no reactions from the vaccine. She took Arnica before and after the vaccine, and then 4 days later she started loosing feelings in her feet, which she thought was Raynaud's disease and moved from state to state. It moved from the arch of her foot to her heel. She then lost feelings of the tips of her fingers to her hand. Within a week after that she was starting to get very dizzy and she would go outside and walk her dog and fall on her hands and knees. She then within the next 3 weeks she has daily migraines and takes Imitrex for that, but she has seen 14 neurologists and been detoxed 4 times from that and take her off and then goes back on it. She is now 2 1/2 months into it and the Imitrex is not working and taking Tylenol. She has been in bed for 5 days this week and is totally disabled at this point and living alone, so she is having difficulty She has been up to facility to neuromuscular group and has peripheral neuropathy and has read the medical journals and that you don't get it over night. She is now being moved to the neuro autoimmune group and is waiting to be seen for testing from there. She cannot get dressed, open cans and all of her fine motor skills are gone and cannot text because she is missing the keys while she does so. She feels that with POTS the vaccine has activated all reactions one would have with it. She has read an article regarding POTS and knows that the vaccine caused it. She has sent the article to her neurologist. She also has chronic fatigue but she is exhausted all the time and cannot sleep for more than 3-4 hours at a time because of the pain of her hands and feet. She sleeps with polar mittens on to keep her hands warm, and her hands stay cold and wears gloves to keep her hands warm. She also sleeps with 3 pairs of wool socks due to the coldness of her feet as well. She has intermittent cold/hot with her hands all night long. She started having chest pains and did not know what was going on and had a lot of numbness and she did go to the ER and that was right before her 2nd vaccine. Her daughter was in town and took her there. They drew some blood and also has some spinal issues and a pinched nerve in her back. They did not do an MRI as the radiologist was going home and they wanted her to stay over night and she did not as she was having her 2nd vaccine the next day. She did have a CT scan that did not show anything. She has also experienced loss of appetite, but has gained 10#, so not sure what is going on with that. She had her 2nd vaccine on 4/1/21, Moderna on right arm, LOT#021A21A. She then called an old colleague who called and got her an APT at facility with a neurologist. Waiting on that APT.
70 2021-06-05 hypertension, chest pain, hypertension, chest discomfort, chest pain, chest discomfort Systemic: Abdominal Pain-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chil... Read more
Systemic: Abdominal Pain-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Diarrhea-Severe, Systemic: cannot move-Severe, Systemic: Hypertension-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
70 2021-06-06 hypertension I'm getting odd bumps on my chins and chest from the vaccine. I had a serve fever and my blood pres... Read more
I'm getting odd bumps on my chins and chest from the vaccine. I had a serve fever and my blood pressure was really high .
70 2021-06-07 blood pressure increased, heart rate increased, palpitations, chest discomfort, chest pain 12 hrs after injection, experienced heart palpations, rapid pulse; then after 2nd dose on Feb 10, 20... Read more
12 hrs after injection, experienced heart palpations, rapid pulse; then after 2nd dose on Feb 10, 2021, had 24 hours of severe chills, felt really bad; about three weeks later, started having very slight chest pain; first noticed it at night in bed; at present my symptoms include increased pulse rate, increased blood pressure, chest pain, chest soreness under pressure, difficulty sleeping on my left side sometimes, chest soreness when I move my upper torso a certain way, burning sensation in center of chest, left side of upper chest seems slightly bigger than right, like it is slightly swollen
70 2021-06-08 hypertension, troponin increased, fast heart rate, increased heart rate Patient is a 70 yo F with PMHx COPD chronically on 3L O2, CHF, DM Type II, Hypothyroidism, HTN, CAD,... Read more
Patient is a 70 yo F with PMHx COPD chronically on 3L O2, CHF, DM Type II, Hypothyroidism, HTN, CAD, GERD and OSA not on bipap anymore at home presenting to the ER with difficulty breathing on 6/3/21. Due to acuity of condition limited history able to be obtained from patient and limited history obtained from patient's sign other on admit, who reported patient was having difficulty breathing earlier the day of admit and patient's boyfriend called EMS. Patient's boyfriend did report she was at baseline and denied any changes in management except she received her second dose of the COVID vaccine the day prior 6/2/21. EMS found the patient in respiratory distress and placed on non-rebreather and given 10mg Decadron. Once in the ER patient continued to appear in respiratory distress despite 3 treatments with Duo-nebs and patient was placed on NIPPV. Due to aggressive behavior of hitting staff and agitation in which patient appeared confused and attempted to continuously pull out IV lines and oxymask patient was given two separate doses of IV 0.5mg Ativan. pt arrived with a fever of 101.1, tachycardia 148, hypertension 190/144, respiratory rate of 38 she was admitted with severe SIRS response/possible sepsis with acute hypoxic respiratory failure without septic shock: - CXR negative for acute pathology/CT neg for acute pathology - ESR 64, CRP 5.5, D-dimer 540 - no leukocytosis present on lab work, renal and hepatic function WNL - EKG showed sinus tachycardia at rate 133 with RBBB - UA negative for acute infection - Blood cultures negative - Patient was started on IV Vancomycin and Zosyn which was discontinued the following day as infection ruled out - HS troponin 18, 1hr 15, delta -3 - ABG showed normal pH with hypercapnia at 58 she was also admitted for Acute metabolic encephalopathy: - Patient became agitated and was hitting staff in the ER - Unable to focus or respond more than a couple short words in ER without closing eyes - Given Ativan 0.5mg IV twice in ER as attempting to pull off lines and oxygen she was admitted to the ICU. the following day she was doing better but had body wide tremulousness and muscle fasciculations. she was eventually transferred to the medical floor. IV fluids were discontinued. Her fever defervesced. Eventually oxygen was weaned down to her baseline and she was discharged on 6/8/21 back home with home health services. She was felt to have severe SIRS response following covid 19 vaccination and it is now listed as an allergy. To her knowledge she has never been infected with covid-19
70 2021-06-08 loss of consciousness Arm was hurting at injection site; got a fever that evening. I started feeling really really tired.... Read more
Arm was hurting at injection site; got a fever that evening. I started feeling really really tired. I went to bed. I woke up the next morning, I had an uncontrollable urge to go to the bathroom - bladder was screaming like mad - I was holding the bottom of my stomach as it felt like it was going to fall out. Bladder started leaking before I got there. When finished, I had to shuffle to the foot of my bed (couldn't pick up my feet). And that was last time I remember when I came to on the opposite side of bed on the floor. Then I tried to get up off the floor and my knees kept collapsing. The weight of my body would shift every time I would try to do something. Scars on my forehead, top of head, knees and elbows from trying to get up. And I couldn't. I pulled the charging cord to my phone off the night stand and called my daughter. She came and asked me the time and I thought it was 7 something. It was 9 something by then. There was not a muscle in my body that would hold me up. I was a rag doll. She put my arms over her back and stood up and pushed me on to the bed and had to take the rest of the body and turn it right on the bed because I couldn't move it. Spent the first week in bed. The biggest thing was to go to the bathroom and it took forever. I was shuffling so slow, I was using my toes to make my feet move. I couldn't sit up in bed - I would just slide down. Couldn't get in to see my doctor - spoke to him on the phone. Dr called the Paramedics/fire dept. I was trying to go from my bedroom to my front door to undo the security lock thing for the building but I didn't get there before they did and they found a way to unlock my door. They did check up with vitals - blood pressure; heart rate; temperature. They didn't find anything wrong. I had to promise them that my daughter would take me March 23 - Urgent Care that night. I shuffled back to their COVID Urgent room; doctor checked me over and said he needed to take bloodwork and x-ray to see my head. Went to facility right across the street for that. Visually they could see something was wrong but the tests don't show anything wrong. He (my doctor) thinks that what happened was caused by a clash between the vaccine and the Neurontin (Gabapentin). They don't know what to do to undo what has happened. Still have a loss of muscle strength -it has improved about 25% from what it originally was.
70 2021-06-09 hypotension, oxygen saturation decreased I woke up that morning of 03/24/2021 I did not know where I was. My husband called the ambulance, wh... Read more
I woke up that morning of 03/24/2021 I did not know where I was. My husband called the ambulance, when admitted I was diagnosed with septic shock, temp was 106, O2 was low, and bp was low. I was in the hospital for 6 days.
70 2021-06-10 palpitations Heart palpitations. Still occurring. Itchy skin rash all around my torso. Still occurring. General c... Read more
Heart palpitations. Still occurring. Itchy skin rash all around my torso. Still occurring. General confusion. Still occurring.
70 2021-06-13 chest discomfort Patient reports high fever to 101, left arm hurt and swelled and had a "giant hive size of hand prin... Read more
Patient reports high fever to 101, left arm hurt and swelled and had a "giant hive size of hand print" and muscle cramps and biceps turned hard, wrist swelled to where fit bit had to be removed. Then prodrome of shingles started 6/10 and she broke out in the vesicular shingles rash 6/11. right superior anterior chest.
70 2021-06-14 chest pain one month later I had chest pain and severe shortness of breath with low grade fever, lasting three ... Read more
one month later I had chest pain and severe shortness of breath with low grade fever, lasting three days. Tested negative twice for covid. I continue to have minor chest pain. (After the second shot I had chills and low grade fever for 24 hours..nothing much)
70 2021-06-14 palpitations Immediate, long lasting and very strong heart palpations. Total weakness. Could not stand up for 1... Read more
Immediate, long lasting and very strong heart palpations. Total weakness. Could not stand up for 10-11 minutes. Had to have assistance walking. Lasted for a day. Next 3 days trying to move or function as if I were walking through thick mud. As of 6/15 2021 am still weak with strong dizziness.
70 2021-06-15 chest pain chest pains, head ache dizziness, light headedness, soreness at injection site.
70 2021-06-16 atrial fibrillation, cardiac failure congestive, ejection fraction decreased New Onset Cardiomyopathy with low ejection fraction, CHF, new onset AFIB
70 2021-06-17 heart rate increased, atrial fibrillation, chest pain Experienced an episode of rapid heart rate and chest pain consequently diagnosed as Atrial fibrillat... Read more
Experienced an episode of rapid heart rate and chest pain consequently diagnosed as Atrial fibrillation in the emergency room. Was cardioverted and placed on Apixaban and Diltiazem . Returned home
70 2021-06-20 blood pressure increased increased blood pressure. had a systolic reading of 191 at home, came to pharmacy to check, had a s... Read more
increased blood pressure. had a systolic reading of 191 at home, came to pharmacy to check, had a systolic reading of 244
70 2021-06-20 very slow heart rate Respiratory failure; bradycardia with heart block
70 2021-06-20 blood clot I had unexpected and severe bleeding from my uterus. I've had 2 surgical procedures D&C and Ablation... Read more
I had unexpected and severe bleeding from my uterus. I've had 2 surgical procedures D&C and Ablation. As a result from the first procedure I developed a blood clot in my leg. Which has lead me to be on a blood thinner medication.
70 2021-06-22 chest pain Chest Pain; Open heart surgery; 2nd dose on 26Mar2021, which she missed; This spontaneous case was r... Read more
Chest Pain; Open heart surgery; 2nd dose on 26Mar2021, which she missed; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain) and CARDIAC OPERATION (Open heart surgery) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure, Cholesterol and Diabetes. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose on 26Mar2021, which she missed). On 19-Mar-2021, the patient experienced CHEST PAIN (Chest Pain) (seriousness criteria hospitalization prolonged and life threatening) and CARDIAC OPERATION (Open heart surgery) (seriousness criteria hospitalization prolonged and life threatening). The patient was hospitalized until 03-Apr-2021 due to CHEST PAIN. The patient was treated with Surgery (Open heart surgery) for Chest pain. On 26-Feb-2021, PRODUCT DOSE OMISSION ISSUE (2nd dose on 26Mar2021, which she missed) had resolved. At the time of the report, CHEST PAIN (Chest Pain) and CARDIAC OPERATION (Open heart surgery) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided. The patient went to urgent care and they sent her to the hospital. At the hospital the patient and had to have an open-heart surgery. She was hospitalized until 03-Apr-Apr2021. Before the open-heart surgery consumer was taking medications for cholesterol, BP, and diabetes. After the open-heart surgery many meds were added for the patient, but patient does not know the name of the medications at the time. The was due for her 2nd dose on 26-Mar-2021, which was missed. The patient gave safety consent to follow up via phone. Based on the current available information and temporal association between the use of the product and the start date of the event chest pain! a causal relationship cannot be excluded; however, for the event "Product dose omission", assessed is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event chest pain! a causal relationship cannot be excluded; however, for the event "Product dose omission", assessed is not applicable.
70 2021-06-22 ejection fraction decreased, heart attack, troponin increased, chest pain Patient is a very pleasant 70-year-old female with a past medical history significant for type 2 dia... Read more
Patient is a very pleasant 70-year-old female with a past medical history significant for type 2 diabetes, hyperlipidemia, hyperthyroidism, depression and past history of coronary artery disease/inferior wall MI in 2001 resulting in PCI who presented to the emergency room on 6.18 with a chief complaint of recurrent substernal chest pain that has been occurring since it started suddenly on June 12 associated with nausea, two episodes of vomiting and sweating. She reported prior to that she was in her usual state of health. She admits to a chronic issue with going up her 28 stairs in her home but reports that there has been no change in the shortness of breath pattern doing the stairs or in her usual joint pain doing the stairs up until this past Saturday. She denied any recent illness any fever or chills any diarrhea or any abdominal pain. She just had her second Covid vaccine on June 6. She takes an aspirin and atorvastatin and tries to control her blood sugars.She last had an echocardiogram in August 2018 as well as a stress echo which revealed a normal ejection fraction and findings consistent with an RCA/PDA distribution abnormality there was no significant valvular abnormalities or other stress-induced regional wall motion abnormalities. In the emergency room she received nitroglycerin paste, morphine and an aspirin and then was started on a heparin drip at the direction of cardiology. She was admitted with a NSTEMI and unstable angina and transferred to a higher level of care on 6/21 where coronary angiogram, showed severe left main and 2 vessel CAD. She was then referred for emergent CABG and on 6/21 she underwent CORONARY ARTERY BYPASS GRAFTING; LIMA-LAD; ENDOSCOPIC VEIN HARVEST OF THE LEFT GREATER SAPHENOUS VEIN; SVG-MARG; SVG-PDA; ON CARDIOPULMONARY BYPASS . She remains hospitalized as of 6/23/21 on open heart.
70 2021-06-23 fast heart rate, loss of consciousness, chest pain, atrial fibrillation Hospital HPI Patient is a 70 y.o. female with a PMH significant for bipolar disorder , anxiety/depre... Read more
Hospital HPI Patient is a 70 y.o. female with a PMH significant for bipolar disorder , anxiety/depression , fibromyalgia, osteoarthritis, aortic stenosis status post TAVR x2 in 2001 and 2019, CAD, AFib on Eliquis, hx of CVA on ASA/plavix, HTN, DVT s/p IVC filter, chronic diastolic heart failure who initially presented to the hospital on 5/28 to SLW as a stroke alert with aphasia, confusion, repetitive speech. Not a tPA candidate given she is on systemic anticoagulation with Eliquis for Afib. Imaging negative for hemorrhage, ischemia, and large vessel occlusion. Patient was admitted to the ICU, she remained confused, but alert. The next morning, the patient was found to be unresponsive and have twitching to bilateral sides of the face and left gaze for preference. Seizure was suspected. Patient was given Depakote and Ativan. Neurology was consulted. Patient was started on Vimpat. No significant improvement in her exam. Patient was intubated for airway protection, and transferred to hospital for continuous video EEG monitoring. Upon arrival to the ICU, the patient was intubated and sedated on propofol at 40. Sedation was held the patient became agitated. Would not open eyes spontaneously, but was moving all 4 extremities equally and pulling at restraints. Patient purposeful, but not following commands. Attempting to sit up in bed. Patient was initiated on video EEG monitoring to rule out intermittent seizure activity and postictal state. Repeat labs drawn and electrolytes repleted. Patient hemodynamically stable. Patient started on Precedex for sedation. Patient's daughter was updated via the telephone. Patient's daughter reports that she was recently started on baclofen for her hip pain. Patient was given a prescription which she filled on 5/26 for 20 tabs of 20mg each. Patient's daughter reports that it is possible she could have taken more than the prescribed dose in order to make her pain better faster. Daughter states she does not think she took the whole bottle, but is unsure of how many she took. Patient's daughter also reports that she drinks alcohol daily, 10 oz glasses of gin and vodka." Hospital Course Brief ICU course: Patient intubated for airway protection and transferred about plan for continuous video EEG monitoring. EEG was negative for any seizure activity and patient's antiepileptics were stopped. LP and MRI were negative for any etiology of encephalopathy and neurology signed off. Patient's mental status was eventually improving and encephalopathy was thought to be secondary to polypharmacy. Throughout course she had multiple extubations a re-intubation but finally has been extubated since 6/10 and on room air. Course was also complicated by acute blood loss anemia secondary to left flank/abdominal wall hematoma status post empiric embolization of T8 and T9 intercostal arteries. Initial planning to transfer out to floor on 06/11 however prior to leaving ICU patient had episode of SVT and was kept for further monitoring. During this event her Coreg was uptitrated and her home metoprolol was added without any more recurrent tachyarrhythmias. Transfer to the floors with SLFM team on 06/14. Patient's mental status had returned back to baseline. Unfortunately on morning of 6/15 patient had an episode of burning chest pain and tachycardic to 150. Alerted and evaluated at bedside. EKG at that time showed AFib with RVR in the 130s. Troponins were obtained which were 0.04 then trended down to 0.03. Cardiology was consulted. Patient's heart rate eventually returned to normal on own and chest pain gradually resolved. Patient should not be on 2 beta-blockers, per Cardiology Coreg was stopped and her metoprolol dose was increased. Patient was continued on IV Lasix for 1 more dose on 06/16 then transition to p.o. Home dose 40 mg daily. Patient remain observed on tele and arrhythmia free, stable, mental status at baseline. On day of discharge, patient remains stable and looked well, wanting to go home. Cardiology cleared patient for home. PT/OT recommended home with PT services. Case management involved for services at home. Plan to discharge with PCP and cardiology follow-up. Advised that her abdominal wall hematoma will slowly shrink and pain will improve appropriately. ---When calling patient to follow up, she stated her symptoms started 4 days after vaccination with COVID vaccine. Symptoms also started day after she reportedly by daughter and patient only taking 2 doses of Baclofen to me today 6/24/21. She presented to ED on 5/28, received COVID vaccine 5/24, and took two doses of Baclofen 5/27.
70 2021-06-25 atrial fibrillation, sinus rhythm, cardiac arrhythmia Premature Vascular Contractions (low pulse rates), atrial fibrillation after having been in sinus rh... Read more
Premature Vascular Contractions (low pulse rates), atrial fibrillation after having been in sinus rhythm for several years
70 2021-06-25 cerebrovascular accident Lethal stroke
70 2021-06-28 chest pain, chest discomfort, inflammation of the heart muscle Chest tightness, chest squeezing, right-sided chest pain. ER visit testing all negative. FU cardio... Read more
Chest tightness, chest squeezing, right-sided chest pain. ER visit testing all negative. FU cardiologist diagnosed vaccine-related myocarditis.
70 2021-06-28 loss of consciousness I had a normal screening and needed 30 minutes to recover after 20 minutes of the vaccine I felt lik... Read more
I had a normal screening and needed 30 minutes to recover after 20 minutes of the vaccine I felt like I was going to faint. I looked at the PA and told her I was going to fall out the chair. I was rushed to the emergency roomand when I got into the room I passed out. The next 4 hours I woke up feeling perfectly fine. Next couple of days I was feverish but I had to visit a few doctors to make sure my organs were still working properly. I now have shortness of breath.
70 2021-06-30 platelet count decreased, blood clot It is complicated because I also at the same time, had another infection. Which was a tick borne inf... Read more
It is complicated because I also at the same time, had another infection. Which was a tick borne infection. This infection sent me to the hospital and that is why they were investigating further, so they noticed I had blood clots. I had a heart procedure at the hospital on June 10 2021 - a Tavr (aortic valve replacement). While I was there they gave me an injectable drug called Lovanox on the 10th and 11th. I was able to walk and do things when I went home, then I started to run a fever and went back to the hospital for 3-4 days for observation. At home I ran a fever again, I went back to the hospital and they ran tests. My platelets ran extremely low and then they did blood testing and saw I have something called HITT. HITT as I understand it is a condition where a Heparin injection attacks platelets and cause clots in the body. I still have the condition until those antibodies clear out of my body and I do not know if the vaccine of Moderna was a reasoning for this at all, but it is possible.
70 2021-07-01 blood pressure increased, chest discomfort I woke up at 6 AM and had pressure on my chest. I walked 2 miles and came home. I took my BP, which ... Read more
I woke up at 6 AM and had pressure on my chest. I walked 2 miles and came home. I took my BP, which is normally 120/70, but this time it was about 167/92. I kept checking it throughout the day. The highest it got was 212/94. The next day, on 6/23, I went to the doctor. They took my BP, which was still high. The nurse practitioner asked me questions. I had an EKG and blood work done. Nothing abnormal showed up on the EKG. I was then sent to the ER. Another EKG was done and more blood work was done. My blood pressure was 215/102 at the ER. I was given nitroglycerin, which brought the BP down. I was kept under observation for a couple of hours and then sent home. The next day, I got a call informing me I had a UTI. I was given fluconazole, nitrofurantoin mono. I took them for 5 days. I'm still having a little pressure on my chest, but maybe it's the heat. I'm still walking and using my exercise bike. I decided to fill out the VAERS report, because I know of 2 other people who developed a UTI after getting the vaccines. During the follow-up doctor visit on 6/29, my BP was taken and he talked to me, but no tests were done.
70 2021-07-04 cerebrovascular accident patient suffered a stroke and was hospitalized on june 22 2021 week long stay in hospital facility
70 2021-07-04 blood clot person was found dead 3 and a half weeks after last shot
70 2021-07-05 chest pain, cardiac arrest, heart failure chest hurt; pulmonary issues; heart failure; kidney failure; Cardiac arrest; flu like symptoms; ting... Read more
chest hurt; pulmonary issues; heart failure; kidney failure; Cardiac arrest; flu like symptoms; tingling in arms and feet; rashes in the body; itchy; weakness to the point that she could not walk; passed away; cardiac arrest; hurting arm; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away), CARDIAC ARREST (cardiac arrest), CARDIAC FAILURE (heart failure), RENAL FAILURE (kidney failure), CARDIAC ARREST (Cardiac arrest), INFLUENZA LIKE ILLNESS (flu like symptoms), PARAESTHESIA (tingling in arms and feet), RASH (rashes in the body), PRURITUS (itchy), ASTHENIA (weakness to the point that she could not walk), LUNG DISORDER (pulmonary issues) and CHEST PAIN (chest hurt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion hospitalization), PARAESTHESIA (tingling in arms and feet) (seriousness criterion hospitalization), RASH (rashes in the body) (seriousness criterion hospitalization), PRURITUS (itchy) (seriousness criterion hospitalization) and ASTHENIA (weakness to the point that she could not walk) (seriousness criterion hospitalization). 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (hurting arm). On 27-May-2021, the patient experienced CARDIAC FAILURE (heart failure) (seriousness criteria hospitalization and medically significant), RENAL FAILURE (kidney failure) (seriousness criteria hospitalization and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization prolonged and medically significant) and LUNG DISORDER (pulmonary issues) (seriousness criterion hospitalization). On 05-Jun-2021, the patient experienced CHEST PAIN (chest hurt) (seriousness criterion hospitalization). On 14-Jun-2021, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criteria death and medically significant). On 27-May-2021, CARDIAC ARREST (Cardiac arrest) had resolved. The patient died on 14-Jun-2021. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. At the time of death, CARDIAC FAILURE (heart failure), RENAL FAILURE (kidney failure), INFLUENZA LIKE ILLNESS (flu like symptoms), PARAESTHESIA (tingling in arms and feet), RASH (rashes in the body), PRURITUS (itchy), ASTHENIA (weakness to the point that she could not walk), LUNG DISORDER (pulmonary issues) and CHEST PAIN (chest hurt) outcome was unknown and PAIN IN EXTREMITY (hurting arm) had resolved. No relevant medical history was reported. No concomitant medication provided. The patient was having respiratory problem few days after the 2nd dose along with other issues. She was administered with asthma medicines. The name was not specified. Action taken with mRNA-1273 in response to the events was not Applicable. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: cardiac arrest
70 2021-07-06 blood pressure increased Eyes turned very red, swollen, dry and itchy. My eyes were also weeping. This was the worst eye in... Read more
Eyes turned very red, swollen, dry and itchy. My eyes were also weeping. This was the worst eye infection/reaction I have ever had. Nothing seemed to help. I had avoided going out throughout the pandemic, especially avoiding the doctor's office or hospital I made a Video appointment and the dr recommended I come.
70 2021-07-06 fainting First dose (February 25): "Covid Arm" (left arm) and reactive arthritis (wrist) starting a few days... Read more
First dose (February 25): "Covid Arm" (left arm) and reactive arthritis (wrist) starting a few days after injection - duration was approx. one week Second dose (March 25, 2021): approx. one week after injection - reactive arthritis (left hand) and constant headache, lasting approx. 2 weeks. Also, developed vertigo and was markedly light-headed/dizzy. One episode syncope (emergency room, but had no adverse consequences). The dizziness lasted at least 2 months. Subsequently, starting approx. late May, developed tinnitus. This contined and I am still experiencing it. I have scheduled an appointment with an ENT doctor to rule out/in a role for general hearing loss in the ear ringing. Answer to #21 is an estimate
70 2021-07-07 chest pain Fever, cough, fatigue, loss of appetite, nausea, diarrhea, chest pains, plural effusion.
70 2021-07-08 chest pain A week 1/2 after getting 2nd shot I woke up with severe chest pain. Sharp pain when trying to sit up... Read more
A week 1/2 after getting 2nd shot I woke up with severe chest pain. Sharp pain when trying to sit up or turn over. Took my breath away. Finally was able to get up and take asperin. Continued all day and for the next couple of days then syptarted to subside. Came back again for about 3 days, went into my back and right shoulder, ; subsided gradually and went away. The whole event was about 9 days. I have had nothing since. My mom had just had a stroke a d I didn?t seek medical treatment.
70 2021-07-08 hypertension, heart failure Heart failure sent to ICU; legs swelled; had high blood pressure and her legs swelled; This spontane... Read more
Heart failure sent to ICU; legs swelled; had high blood pressure and her legs swelled; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC FAILURE (Heart failure sent to ICU) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included SIMVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FISH OIL for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC FAILURE (Heart failure sent to ICU) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (legs swelled) and HYPERTENSION (had high blood pressure and her legs swelled). The patient was hospitalized from 11-May-2021 to 14-May-2021 due to CARDIAC FAILURE. At the time of the report, CARDIAC FAILURE (Heart failure sent to ICU) had resolved with sequelae and PERIPHERAL SWELLING (legs swelled) and HYPERTENSION (had high blood pressure and her legs swelled) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: high (High) high. Treatment medication was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: ADR form received: Suspect drug details updated, Concomitant medications added, New serious event added, event details updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
70 2021-07-08 loss of consciousness Passed out; Bruised head; Head bumps; Diarrhea; Dehydration; Hives between fingers; Gastritis really... Read more
Passed out; Bruised head; Head bumps; Diarrhea; Dehydration; Hives between fingers; Gastritis really bad/Gastritis after the vaccine; Too sick to get up out of the chair/Sick since having covid in November; Fell once but caught herself; Weak; Could not get up and down; Gas goes up in the head and neck and shoulder; pain from gastritis; Not yet received her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2020. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), LISINOPRIL and METFORMIN for an unknown indication. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), CONTUSION (Bruised head), SKIN LESION (Head bumps), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydration), URTICARIA (Hives between fingers), GASTRITIS (Gastritis really bad/Gastritis after the vaccine), ILLNESS (Too sick to get up out of the chair/Sick since having covid in November), FALL (Fell once but caught herself), ASTHENIA (Weak), MOBILITY DECREASED (Could not get up and down), FLATULENCE (Gas goes up in the head and neck and shoulder), ABDOMINAL PAIN UPPER (pain from gastritis) and PRODUCT DOSE OMISSION ISSUE (Not yet received her 2nd dose). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), CONTUSION (Bruised head), SKIN LESION (Head bumps), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydration), URTICARIA (Hives between fingers), GASTRITIS (Gastritis really bad/Gastritis after the vaccine), ILLNESS (Too sick to get up out of the chair/Sick since having covid in November), FALL (Fell once but caught herself), ASTHENIA (Weak), MOBILITY DECREASED (Could not get up and down), FLATULENCE (Gas goes up in the head and neck and shoulder), ABDOMINAL PAIN UPPER (pain from gastritis) and PRODUCT DOSE OMISSION ISSUE (Not yet received her 2nd dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information not provided by reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
70 2021-07-10 heart rate increased, atrial fibrillation Rapid heart rate occurred on 05/11/2021 and again on 06/09/2021, both events requiring visit to hosp... Read more
Rapid heart rate occurred on 05/11/2021 and again on 06/09/2021, both events requiring visit to hospital. Have been diagnosed with afib.
70 2021-07-11 blood pressure increased my blood pressure went up over 30 points in systolic and almost 20 points in diastolic. Lasted almo... Read more
my blood pressure went up over 30 points in systolic and almost 20 points in diastolic. Lasted almost 5 months! Experience burning throbbing stabbing pain in both my legs the day after the 2nd shot. To this day I am experiencing same pain in both legs with tingling and numbing feelings at times in my feet and runs up my calves. Happens on and off everyday no matter if I am doing anything or laying in bed! I understand from other people(in other areas of the country) they are experiencing the same, and yet nothing is written about this in any articles regarding side effects of shot. Will this pass or will this progress?
70 2021-07-15 blood pressure increased swollen lymph nodes left side of breast caused positive mammogram blood pressure elevated for 1 mon... Read more
swollen lymph nodes left side of breast caused positive mammogram blood pressure elevated for 1 month, slowly returned to normal
70 2021-07-17 atrial fibrillation was not administered the 2nd dose of the vaccine; atrial fibrillation; afib attack/atrial fibrillati... Read more
was not administered the 2nd dose of the vaccine; atrial fibrillation; afib attack/atrial fibrillation; itchy ant bite like lesions which popped on different sites of her body; itchy ant bite like lesions which popped on different sites of her body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (afib attack/atrial fibrillation) and ATRIAL FIBRILLATION (atrial fibrillation) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. The patient's past medical history included Atrial fibrillation and Cardiac ablation on 06-Jul-2020. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ATRIAL FIBRILLATION (afib attack/atrial fibrillation) (seriousness criterion medically significant). In March 2021, the patient experienced PRURITUS (itchy ant bite like lesions which popped on different sites of her body) and SKIN LESION (itchy ant bite like lesions which popped on different sites of her body). On 04-Apr-2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant). On 12-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (was not administered the 2nd dose of the vaccine). The patient was treated with FLECAINIDE for Adverse event, at a dose of 100 mg twice a day and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Adverse event, at an unspecified dose and frequency. In April 2021, ATRIAL FIBRILLATION (afib attack/atrial fibrillation) had resolved. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), PRURITUS (itchy ant bite like lesions which popped on different sites of her body) and SKIN LESION (itchy ant bite like lesions which popped on different sites of her body) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (was not administered the 2nd dose of the vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 04-Mar-2021, in the morning, the patient experienced had an atrial fibrillation attack and went to the emergency room (ER) where she was given medications to control it. On 04-Apr-2021, the patient had another atrial fibrillation attack and again she went to the ER. The patient had two more atrial fibrillation attacks on unspecified dates in April and she managed these at home by doubling up on her medication. Patient reports that with this, it took 6-7 hours before the atrial fibrillation got controlled. Treatment included: She had an ablation last 06Jul2021 for the atrial fibrillation. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Noting the history of atrial fibrillation may remain as risk factor. This report refers to a case of lack of product dose omission for mRNA-1273, lot # unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Noting the history of atrial fibrillation may remain as risk factor. This report refers to a case of lack of product dose omission for mRNA-1273, lot # unknown.
70 2021-07-18 blood clot in the brain, cerebrovascular accident Stroke with three blood clots to the brain.
70 2021-07-20 heart attack Leading up to my adverse event, I had been feeling more and more tired. I did not have any problems ... Read more
Leading up to my adverse event, I had been feeling more and more tired. I did not have any problems breathing, I just felt tired. I ability to walk had decreased. I noticed it had been going on for some time. I noticed it, but I didn't get concerned because it could have been related to the muscles from my eye condition. I started to feel a decrease in energy all around. The day, 05/30/2021, my husband was not home. I was home alone. I had a zoom call, with some of my friends, and as we were hanging up on the call, I started to feel as if I were going to faint. I did not have any other symptoms besides fainting. My mind felt clear. I had my cell phone next to me, and I texted my friends and told them how I was feeling. I ran to my bathroom because I had to use the restroom. I sat there and felt like I was fighting fainting. My friends called me and I was having problems speaking. I told them I was fainting and I needed their help. They called an ambulance for me, but they are out of state, so there were problems. I contacted someone closer to me to make a call for an ambulance. I was only able to text by dictation, I couldn't type anything. My friend who I called, came over to my house right away. I had to get myself out of the restroom and make it to my front door to let her in. It was difficult. She called 9-1-1 when she got to my house. The paramedics gave me a baby aspirin right away. I felt that I could talk better after taking it. They gave me nitroglycerin as well. They put me in the ambulance and I stayed awake and alert the whole ride. They took me to The Hospital and took me right in for surgery. I was experiencing a heart attack. I had a couple of stints put in and they did it through the groin area. I was alert through this surgery. I felt sensations, but I did not feel any pain. I am now taking a baby aspirin, carvedilol (coreg) 3.125 mg (2 in the AM, 1 at PM), Plavix 5mg (1 per day) and Rosuvastatin 20mg (1 per day). Since I have had the surgery, I noticed that I have had some blood in my urine. I am following up with a Urologist to see what is going on. She wants to put a scope up my urethra to see if she can find anything. As of today, I feel so much better than I did. I can walk better and move more quickly now. I'm very thankful for the doctors at the hospital and how they handled me.
70 2021-07-21 blood clot in the brain When I received my 1st COVID vaccine in Jan, the left side of my face turned red and warm about 25 m... Read more
When I received my 1st COVID vaccine in Jan, the left side of my face turned red and warm about 25 min. after receiving it. I took advil, and put a cool cloth on it. (The left side is where the brain blood clot was found in April) Also, I was quite fatigued after the first vaccine, and had a sore arm for several days. After the 2nd Moderna vaccine, my entire face and neck got red and warm within 22 min. Enough that I turned the car around and went back to the vaccination location to show them. They said they thought I was ok to go home, and to phone 911 if I needed to. When I got home, I again took an advil, like with the first vaccine, and used a cool cloth. Also, had fatigue, and had a sore arm for several days. I am quite concerned that all my recent health issues could be related to the COVID Moderna vaccines I received, as I have heard that each of them have been somehow related to COVID vaccines. 1. The brain blood clot (left side of brain). Severe headache symptoms started on April 8th. In hospital for 5 days, beginning April 22nd. Doctor prescribed Pradaxa blood thinner when I went home from hospital. 2. The COVID toes( sores, rash, inflammation) 3. The full body rash, followed by excessive peeling(which was considered the D.R.E.S.S. syndrome from being on Pradaxa blood thinner for the blood clot) This occurred the last week in May. I was in the hospital for 3 days. Took over 4 weeks to recover; was very ill. 4. The ground glass opacities; respiratory problems with cough. (discovered in CT scan for kidney) 5. The overall feeling of being ill and fatigued for along time
70 2021-07-22 blood pressure increased Approximately 2 weeks after 2nd dose: 1. increased arthritic pain, new ankle swelling pain - needed ... Read more
Approximately 2 weeks after 2nd dose: 1. increased arthritic pain, new ankle swelling pain - needed to use an air cast and ultimately diagnosed as Posterior tibial tendonitis on 6/3/2021 2. muscles so stiff in AM that it was hard to straighten legs -On 3-12-2021 Discussed with Dr. Infectious Dis specialist - treated with new anti-inflammatory herbs and herbs that stabilize mast cells - ? Quercetin 400 mg BID, ginger root 500 mg bid ? cucumin as Meriva 500-SF (Soy Free) 1 BID Dr. added low dose naltrexone now at 3 mg/d. 3. loss of control of blood pressure - 130/80 to 180/90 - increased lisinopril from 10 mg/d to 20 mg/day
70 2021-07-22 fainting First dose (February 25): "Covid Arm" (left arm) and reactive arthritis (wrist) starting a few days... Read more
First dose (February 25): "Covid Arm" (left arm) and reactive arthritis (wrist) starting a few days after injection - duration was approx. one week Second dose (March 25, 2021): approx. one week after injection - reactive arthritis (left hand) and constant headache, lasting approx. 2 weeks. Also, developed vertigo and was markedly light-headed/dizzy. One episode syncope (emergency room, but had no adverse consequences). The dizziness lasted at least 2 months. Subsequently, starting approx. late May, developed tinnitus. This contined and I am still experiencing it. I have scheduled an appointment with an ENT doctor to rule out/in a role for general hearing loss in the ear ringing. Answer to #21 is an estimate
70 2021-07-26 atrial fibrillation I became very short of breath, about two weeks after receiving the vaccine. I didn't know if I was h... Read more
I became very short of breath, about two weeks after receiving the vaccine. I didn't know if I was having a heart attack or if it was maybe lung disease. I felt tired too. I had a doctors appointment with Dr. and she informed me, after doing an EKG, that I had atrial fibrillation. I have been put on Eliquis, 5mg, twice daily for my A-fib. In August, I will be going in for an echocardiogram. In November, I will be seeing a cardiologist.
70 2021-07-27 heart attack mild heart attack; weird breathing issues, It was short bursts of breathing issues; breastbone pain;... Read more
mild heart attack; weird breathing issues, It was short bursts of breathing issues; breastbone pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (mild heart attack) and DYSPNOEA (weird breathing issues, It was short bursts of breathing issues) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COPD since an unknown date and Cardiac catheterization (stent was placed.) on 16-Apr-2021. Concurrent medical conditions included Smoker. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DYSPNOEA (weird breathing issues, It was short bursts of breathing issues) (seriousness criterion hospitalization). On 15-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (mild heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced BREAST PAIN (breastbone pain). The patient was hospitalized from 15-Apr-2021 to 17-Apr-2021 due to DYSPNOEA and MYOCARDIAL INFARCTION. The patient was treated with PARACETAMOL (TYLENOL REGULAR) for Adverse event, at an unspecified dose and frequency. At the time of the report, MYOCARDIAL INFARCTION (mild heart attack), DYSPNOEA (weird breathing issues, It was short bursts of breathing issues) and BREAST PAIN (breastbone pain) outcome was unknown. Patient reports that she had her first Moderna vaccine on 03 Mar 2021 with no side effects. Her second injection was on 31 Mar 20 21. She started having weird breathing problems two days after second vaccine. It was short bursts of breathing issues feeling in breastbone off and on with pain. It seemed fleeting but got progressively worse. A week later it was so severe, so she went to the hospital. On the 15 Apr 2012, the hospital reported that she had suffered a mild heart attack. She was released from the hospital on 17 Apr2021. Her breathing issue still remains. She can walk one and a half mile with no breathing issues then suddenly it will appear out of nowhere even if she is just sitting in a chair. She has an inhaler which she rarely uses but if she uses her inhaler during one of these breathing episodes it does not help at all. She is following up with a pulmonologist on 23 Jul2021. Treatment includes cardiac catheterization and stent placement on 16-APR-2021. Action taken with mRNA-1273 in response to the event was not applicable. Patient's advanced age and medical history of COPD and smoking could be risk factors for the events. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Patient's advanced age and medical history of COPD and smoking could be risk factors for the events.Based on the current available information and temporal association between the use of the product and the start date of the events,a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time.Further information has been requested.
70 2021-07-28 chest discomfort, chest pain, hypertension Prior to event, I felt oddly "ramped up" for a couple days. On 22/06/21, I had onset of chest press... Read more
Prior to event, I felt oddly "ramped up" for a couple days. On 22/06/21, I had onset of chest pressure-pain, strong light-headness, minor nausea, abnormally very high blood pressure. Went to ER, where they treated as potential CAD. Very high BP and symptoms persisted, so sent to hospital. Nitroglycerine helped a lot with chest symptoms. All symptoms declined in hospital and so released after 3rd day. Tropnin not detected. While in hospital, tests were administered to determine cause of event (see below). Underlying cause for this event was not ever determined by tests in hospital or by follow up appts. I took my 2nd Moderna Covid-19 shot on 2/29/21 and there was no repeat of the heart-issues, although I did experi
71 2021-01-10 palpitations 12/24/2020 she reports approx. 20 mins. after receiving the vaccine that she could feel her heart ra... Read more
12/24/2020 she reports approx. 20 mins. after receiving the vaccine that she could feel her heart racing, became extremely dizzy and c/o increased SOB. She reports that after 30 mins. of resting she did have the feeling of her heart racing but cont. of c/o SOB. She noted at her injection site a knot on 12/24/2020 and a 6 in area of redness and swelling at the site. She reports being nauseated on 12/24/2020 where she had an emesis basin available at all times. On 12/25/2020 she reports having nausea, dizziness and fevers of 99 degrees, plus the soreness in her arm. On 12/26/20 she was able to eat and s/s were "easing up". 12/28/2020 she reports other than the arm soreness she was feeling her normal self. On 01/02/2021 she reports having swelling in her arm at her injection site which she reports that the swelling had disappeared, she noted a hard lump in the area and itching at the site.
71 2021-01-12 loss of consciousness, excessive bleeding Very nauseous all night long. Ate a breakfast bar in the morning, threw it up, had dry heaves for a ... Read more
Very nauseous all night long. Ate a breakfast bar in the morning, threw it up, had dry heaves for a while, then seemed to be OK. About and Hour or so later got up to go to the restroom and just remember walking thru the door. Next thing I knew I was on the floor bleeding, passed out approx. 24 hrs after receiving shot. No way to know how long I was out, received head cut.
71 2021-01-13 blood glucose increased 11:25AM Pt complaining of feeling hot and feeling as she was going to pass out. Lightheadedness. D... Read more
11:25AM Pt complaining of feeling hot and feeling as she was going to pass out. Lightheadedness. Denies dizziness, denies SOB. SO2 99%, BP: 138/78, HR:80, Hx of DM2, Ate a small breakfast this AM. " High reading of sugar this AM, about >300" Transferred to wheelchair, feet elevated. Water encouraged. Call to PCP. Notified of incident. 11:55AM BP: 138--70
71 2021-01-13 fast heart rate PT. REPORTED A BRIEF EPISODE OF "LIGHTHEADINESS, AND TACHYCARDIA" EMS ON SCENE EVALUATED PT. PT. RE... Read more
PT. REPORTED A BRIEF EPISODE OF "LIGHTHEADINESS, AND TACHYCARDIA" EMS ON SCENE EVALUATED PT. PT. REPORTS ALL SYMPTOMS RESOLVED WITHIN MINUTES, PT. ABC'S INTACT, WITH NORMAL WOB, LUNGS CLEAR, PT. SYMPTOM FREE,AND DENIES CHEST PAIN OR SOB. PT. NOT TRANSPORTED, PT. REMAINED IN OBSERVATION FOR FULL 30 MINUTES D/T HX. OF ALLERGIES, PT. DENIES HX. OF ANAPHYLAXIS.
71 2021-01-15 oxygen saturation decreased Post 12 hours, sick. All over body. Hurt. Joints. Muscles. Migraine, Beck. Neck. Oxygen was l... Read more
Post 12 hours, sick. All over body. Hurt. Joints. Muscles. Migraine, Beck. Neck. Oxygen was low. Post 38 hors, went to ER. Same symptoms. While there, started getting red welts on left arm. Received benadryl, morphine, and zofran. Released at post 52 hours. Fourth day: Weak. Fifth day: Weak but getting better.
71 2021-01-17 chest pain Extreme soreness site with swelling and redness and heat,elevated temp,lymph node swelling under arm... Read more
Extreme soreness site with swelling and redness and heat,elevated temp,lymph node swelling under arm,soreness joints,pleurisy type chest pain,fatigue. In bed 1 day better today
71 2021-01-18 atrial fibrillation Pt complained at ED of Headache, Nausea, SOB, felt like had been running. Pt in AFIB started on card... Read more
Pt complained at ED of Headache, Nausea, SOB, felt like had been running. Pt in AFIB started on cardizem admitted to hospital 1/15 discharged 1/17
71 2021-01-18 heart rate increased 48 hours after vaccine my heart rate went to.80. Normally it is 60. Slight headache and I couldn't ... Read more
48 hours after vaccine my heart rate went to.80. Normally it is 60. Slight headache and I couldn't sleep.
71 2021-01-19 chest discomfort Moderna COVID-19 VaccineEUA Jan 17: 24 hrs after injection, symptoms included: slight headache, naus... Read more
Moderna COVID-19 VaccineEUA Jan 17: 24 hrs after injection, symptoms included: slight headache, nausea, slight chest tightness. Jan 18: Chest tightness remains and needed inhaler Jan 19 : chest tightness worse and needed nebulizer with Albuterol Sulfate. Jan. 20: same symptoms. Airways feel inflamed. I have intermittent flare up of ?reactive airways,? with the last one October 2020.
71 2021-01-19 chest discomfort After 15 minutes I had tightness in my chest, headache, and felt my senses were hypersensitive (visu... Read more
After 15 minutes I had tightness in my chest, headache, and felt my senses were hypersensitive (visual, focus); felt "speedy". I checked my pulse and it was normal (80)
71 2021-01-20 blood glucose increased Moderna COVID-19 Vaccine EUA AE - Elevated blood glucose outside of norm
71 2021-01-20 heart rate increased, blood pressure decreased 20 minutes after the dose I became flushed and jittery. My blood pressure was 165/90(usually is 130... Read more
20 minutes after the dose I became flushed and jittery. My blood pressure was 165/90(usually is 130/80. My heart rate was also raised. My blood pressure was down to 136 about an hour later. The flushing of my face and the jittery feeling lasted about 24 hours. I also had a headache and fatigue the next day. All symptoms were gone 48 hours later.
71 2021-01-20 palpitations Employee reported to Employee Health complaining of reactions to COVID-19 vaccination. States she ha... Read more
Employee reported to Employee Health complaining of reactions to COVID-19 vaccination. States she has chills, headache and "heart feels like it is jumping around". Denies chest pain. Is leaving work and going home. Instructed to rest, drink lots of water and to seek medical attention if needed.
71 2021-01-21 cerebrovascular accident Sudden onset of expressive aphasia the next morning (0915) after vaccination. Went to emergency roo... Read more
Sudden onset of expressive aphasia the next morning (0915) after vaccination. Went to emergency room and diagnosed with stroke.
71 2021-01-21 haemoglobin decreased Patient had COVID vaccine on 1/16/21 - has been having fevers, fatigue, chills headaches and lighthe... Read more
Patient had COVID vaccine on 1/16/21 - has been having fevers, fatigue, chills headaches and lightheadness - sometimes she feels like she is going to pass out - nausea - She had a negative Covid test on 1/18/21
71 2021-01-21 palpitations Redness and swelling to injection site, diarrhea, headache, palpitations, myalgias
71 2021-01-22 loss of consciousness I spoke to my sister on the phone an hour or two after she got the vaccine and she was slurring her ... Read more
I spoke to my sister on the phone an hour or two after she got the vaccine and she was slurring her words. The next day around 5:38 someone called me to say she was found on the floor in the bathroom between the toilet and the wall. I believe she passed out because she has no recollection of what happened at that time. She was also reported as having a very dry mouth and sweating by the staff. She was taken to ER after they found her in the bathroom. She is currently having trouble getting around, has pain and is very tired. She seems to be improving though.
71 2021-01-22 palpitations, heart rate increased Rapid heart beat...palpitations...lasting approximately 10 minutes
71 2021-01-23 heart rate increased About 10 Minutes after Vaccine I felt a intense heat rising inside my body, I experienced increased ... Read more
About 10 Minutes after Vaccine I felt a intense heat rising inside my body, I experienced increased heart rate, I felt I was going to faint. I thought I was going to die, but it was over in ??less than 10 minutes. I administered vaccines that day and was fine. The next day I felt tired and injection site medium pain. Rash of site a week later.
71 2021-01-24 loss of consciousness Two days following dose one of Moderna vaccine, patient loss consciousness due to buildup of CO2. Up... Read more
Two days following dose one of Moderna vaccine, patient loss consciousness due to buildup of CO2. Upon arrival at ED, it was discovered that patient was taking antibiotics for UTI, and was nonadherent with antibiotic regimen or breathing treatment for underlying COPD. Patient was intubated but has since recovered.
71 2021-01-25 chest discomfort Tightness in chest and asthma like symptoms. Fatigued and aching
71 2021-01-26 chest pain 01/23/2021 severe mid back and chest pain, 100.3 fever at ER. Negative covid test but double pneumo... Read more
01/23/2021 severe mid back and chest pain, 100.3 fever at ER. Negative covid test but double pneumonia diagnosed as probable covid. Prescribed azithromycin, ondansetron, albuterol sulfate, zicam, extra vitamin D &C
71 2021-01-27 cerebrovascular accident Stroke, death
71 2021-01-27 hypertension arm heaviness, migraine-severe head pain, confusion, dizzy, blood pressure high, site loss Tylenol ... Read more
arm heaviness, migraine-severe head pain, confusion, dizzy, blood pressure high, site loss Tylenol as needed, migraine medication, pt had to go to ER 1/28/2021
71 2021-01-27 pallor, heart rate increased pt reported began feeling dizzy/ light headed during the recovery period. pt was noted by staff to b... Read more
pt reported began feeling dizzy/ light headed during the recovery period. pt was noted by staff to be pale in color, pt was taken to triage area and attended by paramedics on site. decision was made by mid-lever provider to transport patient it the Emergency room for further evaluation because patient standing heart was increased to 200.
71 2021-01-28 chest pain, ischemic chest pain Chest pain in patient with angina; took SL NTG and pain resolved
71 2021-01-29 chest pain Fever, nausea, back pain, dizziness/feeling faint, severe chest/rib pain like being punched,
71 2021-01-29 fainting Cjills, fever, body aches, fatigue, one fainting spell
71 2021-01-30 blood pressure decreased Felt nauseous,. BP low when checked at home this am per pt. Ice applied to neck. Responded well and ... Read more
Felt nauseous,. BP low when checked at home this am per pt. Ice applied to neck. Responded well and discharged at 1:35 pm. VS- BP- 130/82, P- 66, Resp- 16 @ 1:25pm.
71 2021-01-30 blood pressure increased patient became dizzy and nauseous 5 minutes after administering vaccine. vitals taken, noted elevate... Read more
patient became dizzy and nauseous 5 minutes after administering vaccine. vitals taken, noted elevated blood pressure that was beyond her normal per patient. Laid patient down on bed. Gave pt water and candy. Vitals rechecked within 5 minutes, blood pressure still elevated with her having same symptoms. Benedryl given by mouth. Pt continued to have elevated BP with worsening BP with every check. Pt still having the nausea and dizziness but it is not getting worse per patient. She starts to have flushing of the face. EMS called to evaluate patient. Patient taken to hospital. This all took place in one hour after administration of the vaccine.
71 2021-01-30 chest discomfort 10:12 - BLOOD PRESSURE 120/84, PULSE 62, OXYGEN SATURATION 98, RESPIRATIONS 18. PATIENT IS COMPLAINI... Read more
10:12 - BLOOD PRESSURE 120/84, PULSE 62, OXYGEN SATURATION 98, RESPIRATIONS 18. PATIENT IS COMPLAINING OF FEELIN WARMER AND FLUSHED IN FACE AND FUNNY FEELING IN CHEST. PATIENT SAYS SHE HAS NEVER FELT THIS FEELING BEFORE. PATIENT DENIES SHORTNESS OF BREATH OR CHEST PAIN, SKIN WARM AND PINK. 10:23 - PATIENT STATES FEELING REMAINS UNCHANGED. PATIENT REQUEST SOME WATER, WHICH WAS PROVIDED, AND PATIENT TOLERATED WELL 10:29 - OXYGEN SATURATION 98, PULSE 67. PATIENT STATES FEELINGS DECREASING 10:38 - PATIENT STATES NO FAST HEART RATE, SHE DRANK WATER AND TOLERATED WELL. COLOR GOOD, DENIES CHESTPAIN. PATIENT STATES SHE FEELS NORMAL 10:45 - OXYGEN SATURATION 97, PULSE 65. PATIENT DROVE SELF HOME
71 2021-01-30 chest pain, palpitations, hypertension, blood pressure fluctuation Metal taste in mouth during 15 minute after shot, 35 minutes later tingling on mouth area and then t... Read more
Metal taste in mouth during 15 minute after shot, 35 minutes later tingling on mouth area and then tingling and shooting pain on entire face area. Went back to clinic and they gave me 2 Benadryl 50 mg and monitored my blood pressure. Was high when I got in and after Benadryl dropped significantly. I was told to take 2 Benadryl at 6pm which I did. Tingling stopped with Benadryl. Not feeling right for next 5 days with shortness of breath, chest pains and blood pressure fluctations from high to low. Went back on 1/28/2021 PA did EKG and suggested that I see my cardiologist. On evening of 1/29/2021 I experienced heart racing, chest pain, shortness of breath, cough and then extreme throat pain. Took 1 benadry
71 2021-01-31 blood glucose increased, troponin increased Resident c/o nausea evening of 1/29 (nausea common for her post dialysis), had a large emesis at app... Read more
Resident c/o nausea evening of 1/29 (nausea common for her post dialysis), had a large emesis at approx 2220, 0030 (unusual for resident to vomit)- received Zofran per order. Skin cool and damp, Blood sugar 147 (checked due to h/o diabetes and poor intake). At approx 230am Blood pressured checked and noted to be 52/29. Resident transferred to ER, intubated and transferred to higher level of care where she passed away on 1/30 at 736pm. Resident's medical notes indicated likely shock, cardiogenic in nature, sepsis (source unknown) along with a multitude of other co-morbidities that resident has.
71 2021-01-31 chest discomfort On Jan 31, had a scratchy feeling on L back, under the bra area and on L arm (upper, back). It was ... Read more
On Jan 31, had a scratchy feeling on L back, under the bra area and on L arm (upper, back). It was irritating, itchy and slightly painful. During the night, the same symptoms. A little more painful today, also noted red marks on the back area and arm. Appears to be Shingles. Also yesterday I had a slight discomfort in my Left chest. That remains today.
71 2021-01-31 chest discomfort chest discomfort
71 2021-02-01 fainting, loss of consciousness PATEINT FELT FINE ON THE HOME FROM PHARMACY, STARTED FILLING ILL (NOT QUITE HERSELF) BEFORE BED. SHE... Read more
PATEINT FELT FINE ON THE HOME FROM PHARMACY, STARTED FILLING ILL (NOT QUITE HERSELF) BEFORE BED. SHE AWAKENED AT 5:45 AM. FELT AS IF SHE WAS GOING TO FAINT. SAT DOWN AND PASSED OUT AND HAD A SEIZURE. SLID OUT OF THE CHAIR AND URINATED ON HERSELF AND THE FLOOR. WAS TRANSPORTED BY AMBULANCE TO HOSPITAL.
71 2021-02-02 chest discomfort 15-30 min developed symptoms of chest tightness, vision abnormality -described as increased vision a... Read more
15-30 min developed symptoms of chest tightness, vision abnormality -described as increased vision acuity "like someone on amphetamines". Symptoms would come and go for about 20 hours and then resolved
71 2021-02-04 atrial fibrillation AFIB; A spontaneous report was received from a nurse concerning a 71-year-old, female patient who re... Read more
AFIB; A spontaneous report was received from a nurse concerning a 71-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced AFIB (Atrial fibrillation). The patient's medical history including COVID-19. Concomitant product use was not provided. On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient was hospitalized for two days with atrial fibrillation. The patient received Cardizem IV, converted back to sinus rhythm and discharged home two days later on Lopressor PO. Treatment for the event included Cardizem IV and Lopressor PO. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event AFIB was unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of atrial fibrillation. This event occurred 1 days after first dose of mRNA-1273, lot # 013L20A. Treatment included Cardizem iv and Lopressor po. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
71 2021-02-05 blood glucose increased Blood sugar spiked on 2/5 AM and very sore arm 10 AM started with chills, fever 100* nauseous By 5... Read more
Blood sugar spiked on 2/5 AM and very sore arm 10 AM started with chills, fever 100* nauseous By 5AM on 2/6 felt perfectly fine
71 2021-02-07 heart rate increased, blood pressure increased Rapid Heart Rate, elevate BP
71 2021-02-08 low platelet count, chest pain, fibrin d dimer increased, anaemia, haemoglobin decreased, platelet count decreased I work at medical center where patient is being treated for a new diagnosis of Acute monocytic leuk... Read more
I work at medical center where patient is being treated for a new diagnosis of Acute monocytic leukemia. I was able to that the patient was vaccinated with Moderna vaccine on 1/16/2021, patient does not have the vaccination card with the Lot number so this is unknown at this time. Here are the details I see in the chart. Patient arrived on 1/30/2021 at 2100, per History and physican patient has not been feeling well for about a week and a half, and had received the moderna vaccine approximately 2 weeks prior to this time. Doctors note states about a week after first COVID vaccine she noted chest and back pain, dyspnea, high grade fevers and for this went to the ER on 1/28/21 and found to have anemia Hemoglobin 10 with normal LFTs. She was thought to have a reaction to vaccination and sent home. When her symptoms did not get better she went to ER again on 1/30 and found to have Hemoglobin down to 8 and marked LFTs elevation. Pathology evaluated elevated WBC and showed monocytosis and possible blast cells and patient transferred for further workup. per oncologist patient went to primary care about 6 months ago and had a normal CBC. Patient was started on chemotherapy for diagnosis of AML during this admission, as of 2/9/2021 patient remains inpatient, is intubated in ICU with prognosis unknown at this time.
71 2021-02-09 heart rate increased 10:03 voice hoarse, heartbeast fast B/P 160/86 Pulse 99 O2 sat 97% 10:06 still hoarse, B... Read more
10:03 voice hoarse, heartbeast fast B/P 160/86 Pulse 99 O2 sat 97% 10:06 still hoarse, B/P 150/90 Pulse 90 O2 sat 97% took sip water 10:15 voice normal B/P 140/89 Pulse 78 )2 sat 98% 10:18 Recovered and sent home with husband
71 2021-02-10 hypertension Admitted to the Emergency Room. Reason for visit: Allergic Reaction. Diagnosis: Adverse effect of dr... Read more
Admitted to the Emergency Room. Reason for visit: Allergic Reaction. Diagnosis: Adverse effect of drug, initial encounter. Following issue addressed: High priority for COVID-19 virus vaccination. Three (3) hours in the emergency room. Short of breath/Yawning/Difficulty breathing/Trouble with breathing/Dried mouth. Blood pressure sky rocked. Muscles pain days after. Due to my reaction, after first dose, Dr recommend me not to take the second dose of the vaccine.
71 2021-02-10 lightheadedness the day of injection had usual vaso vagal response but very lightheaded. 4 hours after injection hea... Read more
the day of injection had usual vaso vagal response but very lightheaded. 4 hours after injection headache and backache began. took tylenol and they subsided. no rash at injection, but next day arm was sore but it passed. 11 days after injection, rash about 1.5 inches in diameter appeared at site. is warm to touch and tender to touch.
71 2021-02-11 chest discomfort 1240 S/p vaccination reports complaints of SOB, tightness in chest; medical monitoring and after 10 ... Read more
1240 S/p vaccination reports complaints of SOB, tightness in chest; medical monitoring and after 10 minutes reports "feels better" with no additional complaints or incidence Vitals assessed BP 165/90 HR 78 O2 sat 98% RA; 1248 BP 130/76 HR 59 O2 sat 99% RA Released from facility w/husband
71 2021-02-11 pallor Patient called staff over and told him she was going to faint. staff got senior nurse to help assess... Read more
Patient called staff over and told him she was going to faint. staff got senior nurse to help assess. Other nurse which was at pt site. Patient leaning forward and then sat back head tilted backwards, eyes opened and non-responsive. Sternal rub performed and other noxious stimuli performed. Continued until pt became responsive. app less than a minute late patient became responsive. Alert and Oriented X 4, Vital signs obtained. encouraged Patient to drink water and take deep breaths. Patient stated incident of fainting occurred prior in dermatologist office. No follow-up care was given after the doctors visit. patient became nauseas and vomited. She was clamy and pale. Patient was encouraged to go to the hospital and would not let us call EMS. Said she would not take public trasportation home. She will take a cab and call her PCP in the morning and follow-up care. Staff verbalized that it was unsafe for her to go home rather than the hospital. patient denied any further dizziness, nausea or respiratory distress. Stated she just felt unwell and needed to rest . Staff made her sign "Refusal of Immediate Care Against Medical Advice". Patient then called uber and staffed member escorted pt into cab at 7.12pm. We attempted to call patient multiple times between 7.23 pm - 7.30 pm.
71 2021-02-12 fast heart rate Tachycardia
71 2021-02-13 atrial fibrillation, palpitations Heart palpatations and afib, See above
71 2021-02-13 heart rate increased, chest discomfort 5 minutes after receiving the vaccine my chest got tight and my heart rate increased. Was monitor... Read more
5 minutes after receiving the vaccine my chest got tight and my heart rate increased. Was monitored by EMTs on sight. Had Benadryl and inhaler twice. on going Breathing difficulties and heart rate increase. Using Benadryl every 6 hours. Prednisone every 6 hours and inhaler regularly every hour.
71 2021-02-16 arrhythmia Possibly heart irregularities induced by vacine
71 2021-02-16 loss of consciousness Passed out; Unsteady; Slurring her words; Fell into a deep sleep; Tingly in her upper right arm; Fee... Read more
Passed out; Unsteady; Slurring her words; Fell into a deep sleep; Tingly in her upper right arm; Feels like equilibrium is off; Legs feel heavy; Fatigue; A spontaneous report was received from a consumer who was also a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passing out (loss of consciousness), unsteadiness (gait disturbance), slurring words (dysarthria), fell into a deep sleep (hypersomnia), tingly feeling in her upper right arm (paraesthesia), felt like equilibrium was off (balance disorder), legs felt heavy (limb discomfort), and fatigue. The patient's medical history included epilepsy. Concomitant products known to have been used by the patient, within two weeks prior to the event, included clonazepam. On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The patient was slurring her words and fell into a deep sleep. It took three individuals to wake her up. The patient wondered if she passed out. She felt tingly in her upper right arm and it felt like her equilibrium was off, and legs were heavy. The patient was very fatigued. Treatments of these events were not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, passing out, unsteadiness, slurring words, fell into a deep sleep, tingly feeling in her upper right arm, felt like equilibrium was off, legs felt heavy and fatigue, was unknown.; Reporter's Comments: This case concerns a 71 year old female subject, with history of epilepsy, who experienced a serious unexpected event of loss of consciousness after first dose of mRNA1273 (Lot# unknown). Concomitant medication included clonazepam. Very limited information has been provided at this time. Further information has been requested.
71 2021-02-17 blood pressure increased, palpitations 1222 : C/O HEART RACING, FEELING LIGHTHEADED. P 120 INITIALLY. COLOR OK. BP 180/90, P 96. MOVED TO E... Read more
1222 : C/O HEART RACING, FEELING LIGHTHEADED. P 120 INITIALLY. COLOR OK. BP 180/90, P 96. MOVED TO EXAM ROOM SO PT COULD LIE DOWN. HUSBAND PRESENT. 1227 : BP 172/90, P 88 OXY SAT 98%, RR 16. 1232 : 160/90, P 92, R16. STARTING TO FEEL A LITTLE BETTER. C/O SLIGHT HEADACHE. OFFERED WATER. TOLERATING WATER. NO PROBLEMS SWALLOWING. NO OTHER COMPLAINTS. 1238 : 168/90, P 88 RR, 16. 1245 : 158/88, P 75, RR 16. STATES THIS IS CLOSER TO WHAT HER BLOOD PRESSURE HAS BEEN RUNNING LATELY. FEELING MUCH BETTER. 1251 : BP 140/82, P 80, RR 16, OXY SAT 96%. LEFT WITH HUSBAND.
71 2021-02-17 cardiac arrest Per EMS/Hospital report patient had difficulty breathing and cardiac arrest with prolonged CPR (grea... Read more
Per EMS/Hospital report patient had difficulty breathing and cardiac arrest with prolonged CPR (greater than 45 mins in the ER) who was resuscitated. Family subsequently arrived including son and daughter and all family members were in the ER room are in agreement that patient would not want further aggressive cares given her extremely poor prognosis in light of chronic debilitation with numerous medical issues and now a very long period of CPR. Hospital Course After updating family they stated patient would not want further aggressive cares given her grim prognosis and chronic severe and debilitating medical issues. She continued to have myoclonic jerking. She was extubated to comfort cares in the ER and did not pass immediately therefore brought to a room. She received comfort cares and passed away at 0450 with family present.
71 2021-02-18 blood pressure increased Pt arrived in observation area with husband after receiving her first Covid 19 vaccine. Pt sat thro... Read more
Pt arrived in observation area with husband after receiving her first Covid 19 vaccine. Pt sat through most of her allotted time to wait but started to feel lightheaded and dizzy. Pt has a significant pmhx that makes her at risk for Covid 19 and wanted to be checked out in medical room. Pt was moved to a wheel chair and moved to medical room. Pt vs were taken and initial bp was 123/50 and was increased to 137/64 a few moments later. Pt sat in the wheel chair and rested while vs were taken every 15 minutes. Pt bp decreased to 104/47 and felt better. Pt was released to observation area and then to check out.
71 2021-02-18 blood pressure increased 101.6 fevers and chills, day 2-5, 99.6, day 7 Neck pain, frontal headaches, severe Blood pressures u... Read more
101.6 fevers and chills, day 2-5, 99.6, day 7 Neck pain, frontal headaches, severe Blood pressures up 186/106, bp med in teased from 8 mg to 32 mg on day 5.. bps 140/90 by day 7 Bp spike Started on 1st vaccine 01152021, lot 029L20A
71 2021-02-18 chest discomfort tightness in chest after both shots, lasting several minutes. large red circle at injection site bo... Read more
tightness in chest after both shots, lasting several minutes. large red circle at injection site both times, for several days.
71 2021-02-18 palpitations LIGHTHEADED, PALPITATIONS; BP 179/92, HR 99 O2 SAT 99% REPEAT 155/90; HR 88 O2 SAT 99-100%
71 2021-02-19 chest pain Patient complained of chest pain,Non-Cardiac . Onsite EMS was called vitals were taken BP 200/70 ... Read more
Patient complained of chest pain,Non-Cardiac . Onsite EMS was called vitals were taken BP 200/70 BG 82 100% O2 room air HR 58.Patient treated, transported by the EMS to the hospital .
71 2021-02-19 loss of consciousness Morning after I had 2nd shot I felt woosy and passed out on kitchen floor. Called 911 and went to E... Read more
Morning after I had 2nd shot I felt woosy and passed out on kitchen floor. Called 911 and went to ER. They said I was 4th person they?d seen who passed out
71 2021-02-21 blood pressure increased Injection site had a hard lump, had and extremely large red circle around the site, and was hot and... Read more
Injection site had a hard lump, had and extremely large red circle around the site, and was hot and itchy for about two weeks. Also caused an elevation in blood pressure and fluid retention for about two weeks. Slight headache.
71 2021-02-22 atrial fibrillation Moderna COVID-19 Vaccine EUA 14 hrs after dose 2, fever, chills, aches, 20 min AFIB. Back to sinus ... Read more
Moderna COVID-19 Vaccine EUA 14 hrs after dose 2, fever, chills, aches, 20 min AFIB. Back to sinus rhythm after 20 min on its own. 14 hrs after adverse effect started, fever normal, aches gone. Arm red, somewhat swollen. 6 hrs later, arm redder from injection site entire front of biceps down to elbow. Lump at bottom of biceps and enraged lymph node in armpit. 25 hours after noticing COVID arm, swelling down, lump on bicep gone and redness subsiding. Feeling good
71 2021-02-22 atrial fibrillation Lots of bloating; Not feeling good; Arm got really sore; Afib; Lots of chills; Redness itching at th... Read more
Lots of bloating; Not feeling good; Arm got really sore; Afib; Lots of chills; Redness itching at the injection site; Itching at the injection site; A spontaneous report was received from a consumer who is a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed atrial fibrillation, arm got really sore, redness itching at the injection site, lots of bloating, lots of chills and just not feeling good, The patient's medical history included tachycardia, COVID-19, atrial fibrillation, asthma and lung inflammation. Products known to have been used by the patient, within two weeks prior to the event, included diltiazem, flecainide and rivaroxaban. On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) in the left arm intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, at noon, post vaccination, the patient reported she had atrial fibrillation. She was able to get it under control until it started back again at approximately 4 pm the same day. At 6 pm that evening, the patient reported her arm was really sore, there was redness and itching at the injection site. She had lots of bloating, chills and overall, not feeling good. The patient stated it felt like having COVID again. Treatment for the event included hydrocortisone cream. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, afib/atrial fibrillation, was considered not resolved. The outcome of the events arm got really sore, redness itching at the injection site, lots of bloating, lots of chills, just not feeling good, and feeling like having COVID all over again were considered unknown. Follow-up received on 16 Feb 2021 included date of when patient had COVID-19, treatment information and added redness and itching at the injection site to the events.; Reporter's Comments: Based on the current available information, which includes a strong temporal association with onset of the reported events and the use of the product, a causal association cannot be excluded.
71 2021-02-22 blood pressure increased, heart rate increased, heart rate irregular 4 hours of rapid heart rate 14 hours of irregular heart beat 24 hours of diarrhea elevated blood pre... Read more
4 hours of rapid heart rate 14 hours of irregular heart beat 24 hours of diarrhea elevated blood pressure (continuing) Saw my PCP to evaluate reactions and advise whether to get second vaccine dose)
71 2021-02-22 blood pressure increased Loss of control of my bladder. Couldnt walk. Taken to urgent care. Cardiogram was done. BP was over ... Read more
Loss of control of my bladder. Couldnt walk. Taken to urgent care. Cardiogram was done. BP was over 300. Taken to Hospital, CAT scan confirmed that I was NOT having a stroke. after 4 days I was fine
71 2021-02-22 pulmonary embolism Vaccine was administered 2/1/2021 at approximately 9am. Due to self reporting of allergic reaction ... Read more
Vaccine was administered 2/1/2021 at approximately 9am. Due to self reporting of allergic reaction (hives) to Augmentin, patient was monitored on site for 30 minutes. After the monitoring period, she was cleared to go with no issues reported at the time. We were later informed that the patient passed away from a pulmonary embolism on 2/12/2021.
71 2021-02-23 blood pressure increased, chest discomfort Received the vaccine and about 5-7 minutes she felt like somebody put there thumb on the right side ... Read more
Received the vaccine and about 5-7 minutes she felt like somebody put there thumb on the right side of her throat and pushed really hard. This got worse and worse for about 10 minutes and stayed that way for about an hour. She was kept for 45 minutes. Later on it got less and less and by that evening the sensation was gone. On day 29 2/20/21 of the vaccine she started having really crazy dizzy spells, off balance, blood pressure was going up and having the shakes. She went to the ER 02/21/21, which they did a lot of testing, and everything was fine. They did not know if it was due to the virus. She saw her PCP today 2/24/21 and she said that it could be from the vaccine, but again not sure. She called the health dept and told them that she was canceling her appointment and advised that she call us to report the incident. She has also had pressure in her chest, generally overall not feeling well over the last 3 days.
71 2021-02-23 ischaemic stroke Numbness and tingling on right side of body, onset < 24 hours after vaccine was administered. Equili... Read more
Numbness and tingling on right side of body, onset < 24 hours after vaccine was administered. Equilibrium affected. Treated at hospital ER and admitted. Acute ischemic VBA thalamic stroke.
71 2021-02-23 loss of consciousness Passed away; Found unconscious; Coma; Lack of oxygen to the brain; A spontaneous report was received... Read more
Passed away; Found unconscious; Coma; Lack of oxygen to the brain; A spontaneous report was received from a consumer, concerning his mother, a 71-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away, prior to death, patient experienced lack of oxygen to the brain and was found unconscious and went to coma. The patient's medical history reported included seizures. Concomitant medications included phenobarbital, lamotrigine and levetiracetam. On 27 Jan 2021, approximately six days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 01 Feb 2021 at 4 am, the patient was found to be unconscious on the couch, hence she was rushed to the hospital with lack of oxygen to the brain. Later, she went into a coma, hence she was in hospital for 30 hours and then was transferred to a different hospital for a second opinion on 06-Feb-2021, where she was passed away at 02:20 PM. Treatment information was not provided Action taken with mRNA-1273 in response to the events were not applicable. The outcome of events, lack of oxygen to the brain, found unconscious and coma were considered unknown. The outcome of event passed away was fatal as she died on 06 Feb 2021 at 2:20 pm. The cause of death was not provided. Plans for an autopsy were unknown.; Reporter's Comments: This is a case of 71-year-old female subject with a history of seizures who died 6 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Passed away
71 2021-02-23 palpitations Approximately 15 min after receiving the vaccination pt. reported feeling lightheaded, having a head... Read more
Approximately 15 min after receiving the vaccination pt. reported feeling lightheaded, having a headache, possible palpitations, feeling anxious. Pt was able to ambulate and in no acute distress. Her B/P was 142/88, pulse 67, O2 sat 96%. 15-30 min later she stated she felt better but noticed her tongue was tingling and her vision disturbance was improved. She states her vision was hazy earlier. B/P at this time was 130/86, P 68, O2 sat 99%. Benadryl was offered as well as water and juice. Pt. declined. An hour after receiving the vaccine pt. stated she felt much better and left clinic ambulatory in no acute distress. Advised if symptoms worsen to go to the ER or call 911, pt. voiced understanding.
71 2021-02-24 blood pressure increased, hypertension Pt noticed elevated blood pressure readings at home up to 190s systolic 3 days after vaccination. Al... Read more
Pt noticed elevated blood pressure readings at home up to 190s systolic 3 days after vaccination. Also reporting left shoulder and neck pain which also began 3 days after vaccination.
71 2021-02-24 cerebrovascular accident Patient suffered a stroke and passed away
71 2021-02-24 chest discomfort Pruritus developed 11 days after vaccination. Red pruritic rash to the anterior chest and upper bac... Read more
Pruritus developed 11 days after vaccination. Red pruritic rash to the anterior chest and upper back developed 14 days after vaccination. Patient had mild associated shortness of breath and chest pressure with onset of rash. Mild shortness of breath and chest pressure completely resolved within 1 hour.
71 2021-02-24 chest pain, palpitations 2/23/21 about 5pm started having heart palpitations that would not clear up with coughing, and also... Read more
2/23/21 about 5pm started having heart palpitations that would not clear up with coughing, and also had mild shortness of breath with this irregular heart. And mild chest & left neck pain. Symptoms finally started to ease up near 10 pm and I went to bed and was quite tired. I woke up the next morning 2/24/21 around 7 am with reddening, hard swelling, and itching at injection site in my upper left arm. Arm symptoms slowly improving.
71 2021-02-25 blood pressure increased Temp averaging 101.2, extreme sore throat, body aches, lethargy all lasting 24 hours (My normal temp... Read more
Temp averaging 101.2, extreme sore throat, body aches, lethargy all lasting 24 hours (My normal temp is 95.7) Felt impending head ache which never materialized but I rarely get headaches. Felt Nausea never resulted in vomiting. Most sick I have been in decades. Had lesser reaction to first dose of Moderna with sore throat being the most pronounced. That dose was administered on 01/26/2021 at 3PM
71 2021-02-25 hypertension 20-25 minutes metal taste in mouth, high blood pressure
71 2021-02-25 ischaemic stroke Acute ischemic stroke
71 2021-02-27 chest pain, chest discomfort Burning chest and throat, headache, with flu symptoms. Deep cough, chills, hot/cold. No temperature.... Read more
Burning chest and throat, headache, with flu symptoms. Deep cough, chills, hot/cold. No temperature. Overall sick feeling. Really bad on the 24-26th. Called DR on the 19th (?), received Promathazine-codeine syrup. Which helped. After syrup was gone, on the 26th, felt better on the 27th, but all the symptoms came back (except the headache) at night, to the morning of the 28th. It has been 11 days and still feel like having a full blast of flue/cold. Heavy chest and coughing
71 2021-02-27 heart rate increased patient felt dizzy and had complained of increased heart rate
71 2021-02-27 fainting 2/26 9 pm Headache, dizziness, fatigue, slight fever 2/27 8 am Fainted, hit head
71 2021-02-28 hypertension On Saturday she worked 7am to 4pm but was having trouble concentrating to operate her phone. She als... Read more
On Saturday she worked 7am to 4pm but was having trouble concentrating to operate her phone. She also began to have headache dizziness and stomach problems. She did follow up with her doctor office and had high blood pressure. She is currently off work until further notice. Will see neurologist on 3/11/21.
71 2021-02-28 pallor Patient was administered the vaccine at approx 3:30pm. She then waited in the immediate vicinity for... Read more
Patient was administered the vaccine at approx 3:30pm. She then waited in the immediate vicinity for 30 minutes due to an anaphylactic reaction to shellfish in the past. She felt fine and went grocery shopping after the 30 minute wait. Shortly after 4:30pm pt. was in the check out lane and began feeling light headed. She sat down and store staff immediately phoned 911. Pharmacist was notified and went to the scene. Patient was conscious, coherent, pale, cool and clammy feeling, with normal respiration. She had a strong pulse, BP 110/64. EMS arrived within 10 minutes and took over. Blood sugar was checked as patient stated she had not eaten since earlier that morning - it was 127. EMT told pharmacist that the patient refused further medical treatment and was released from their care.
71 2021-02-28 palpitations Vaccine may have caused flare in Graves Disease symptoms. 4 days after the vaccination, I started h... Read more
Vaccine may have caused flare in Graves Disease symptoms. 4 days after the vaccination, I started having heart palpitations. 6 days after the vaccination, I started having double vision in the morning. I have never had heart palpitations from Graves before, although it is a common problem with it I have not had double vision since my eye surgery 5 years ago. Am wondering whether to proceed with second dose of the Moderna vaccine.
71 2021-02-28 lightheadedness Patient had known vagal reaction to first shot and alerted team at registration. Patient was taken t... Read more
Patient had known vagal reaction to first shot and alerted team at registration. Patient was taken to separate classroom to receive shot but insisted on receiving it standing up. After administration patient sat on EMS stretcher in case of adverse event. Patient then began reporting lightheadedness and and nausea. Symptoms subsided 10 minutes later. Patient refused transport via EMS and left shortly after symptoms subsided.
71 2021-03-01 blood pressure decreased kindeys started to fail; blood pressure 60/24; red spots around the injection site; nausea; vomiting... Read more
kindeys started to fail; blood pressure 60/24; red spots around the injection site; nausea; vomiting; diarrhea; cellulitis at the injection site; A spontaneous report was received from a nurse who was also a 61-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24. Medical history included type 2 diabetes mellitus, lung disease, and high blood pressure. Concomitant medication included unspecified cholesterol medicines, unspecified heart medicines, levopridsone, and unspecified type 2 diabetes mellitus medicines. On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot number 057G20A) intramuscularly n the left deltoid for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient experienced cellulitis at the injection site. On 02 Feb 2021, the patient experienced red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24 (no units or reference range provided). The patient was hospitalized from 04 Feb 2021 to 07 Feb 2021. Treatment for the events included hydration, unspecified antibiotics, and levid for blood pressure. Action taken with the mRNA-1273 was not reported. The outcome of the events of cellulitis at the injection site, red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24 was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
71 2021-03-01 hypertension On 1/29, my vision blurred and I could not read the computer e-mails and there were wavy lines in m... Read more
On 1/29, my vision blurred and I could not read the computer e-mails and there were wavy lines in my peripheral left side vision. My blood pressure sky rocketed to 190/82 and I am always in the 120s over 70s or so. I went to the ER where I was given an EKG, a head CT scan, blood work was also done. Next day I had an MRI of my head. All was done to rule out a TIA. Final diagnosis was probably an Ocular Migraine which I have never had. I followed up with an eye doctor who said my eyes were fine. Whether this was coincidental or a reaction to the Covid shot, no one could tell me. I felt fine next day and have not had any other ocular migraines.
71 2021-03-02 chest pain pt states that the next day after receiving the vax her arm was sore. On Wed, arm still hurt, Thurs... Read more
pt states that the next day after receiving the vax her arm was sore. On Wed, arm still hurt, Thursday and Friday she felt ok but still had a red spot on her right arm. On 2/21/2021 she had pain in right chest area and back of right shoulder blade. She noticed she had red pimples on her sternum. On 2/22/2021 she developed rash on her back and chest. She had a headache, pain in her back and shoulder area and her blood pressure was up. She noticed the pimples on her chest/sternum area had burst. She went to her PCP on 2/23/2021 where she was diagnosed w/ shingles and was given a prescription for valacyclovir. Pt completed her meds on 3/2/2021. Pt still has burning and pain. Rash is still present but has not spread and is using Calamine lotion to help dry it up. She is scheduled to have blood work on 3/6/2021 and will see her doctor again on 3/12/2021.
71 2021-03-03 chest discomfort Chest tightness, Asthma, difficulty breathing
71 2021-03-03 chest pain Patient received second Moderna COVID vaccine. While waiting in waiting area, alerted staff that s... Read more
Patient received second Moderna COVID vaccine. While waiting in waiting area, alerted staff that she was feeling SOB. States h/o asthma. Just used inhaler prior to arrival for vaccine. States h/o COVID and now has blood clots in lungs. On a blood thinner. C/o chest pain. States h/o MI. Pt was somewhat diaphoretic in face. C/o some dizziness. RR elevated. AA&O. First responder called with prompt arrival. Pt transferred to ED immediately. Transported via wheelchair. Pt was AA&O when leaving the observation area, still symptomatic. VSS.
71 2021-03-04 fast heart rate day 2 after injection, severe fatigue and body ache; resolved early day 3; day 5 after injection sev... Read more
day 2 after injection, severe fatigue and body ache; resolved early day 3; day 5 after injection severe headache came on suddenly, then dizziness and nausea; six hours after onset of dizziness/nausea, tachycardia of 150 bpm; called paramedics; resolved by time they'd arrived; day 6 after injection feeling good again
71 2021-03-07 chest discomfort At 1:20pm pt. C/o scratch throat,SOB and chest tightness and asked for water to drink.Dr. at chairsi... Read more
At 1:20pm pt. C/o scratch throat,SOB and chest tightness and asked for water to drink.Dr. at chairside. V/s163/94 pulse 85 resp 20 o2 sat 98%RA 1:38 team alert activated 1:41 EMS activated 1:42 epi pen given 0.3mg subq 1:49 ambulance arrived unit 586 report given to EMT. V/s before transported 156/86 pulse 84 resp 20 98% o2 sat RA Pt. Requested to be transported to the nearest/ED hospital
71 2021-03-07 palpitations Patient complained of dizziness, palpitations, shortness of breath 6 min after injection. Patient'... Read more
Patient complained of dizziness, palpitations, shortness of breath 6 min after injection. Patient's vitals at 2:35PM were 158/86 with a pulse of 71. At 2:36PM patient was transported to Patent Assistance Area for further observation. She was discharged home.
71 2021-03-07 palpitations Racing heart. Sharp, stabbing pains in abdomen, breast, neck. Nausea. After 30/40 after inj. Took 75... Read more
Racing heart. Sharp, stabbing pains in abdomen, breast, neck. Nausea. After 30/40 after inj. Took 75 mg Diphenhydramine . Racing hearbeat diminished after 15 min. Tenderness and pain in multiple sites continued and got worse in 1st 24 hours. Leveled out and continued for another 24. On a count of 0-10 pain was a level ten.
71 2021-03-08 blood pressure decreased Pt stated that since she has had her 1st dose her blood pressure has lowered. She thinks this could ... Read more
Pt stated that since she has had her 1st dose her blood pressure has lowered. She thinks this could be from the vaccine
71 2021-03-08 blood pressure increased o Swollen raised small spot with a rash, o Rash Spread from the size of a 50 cent piece to about 8 ... Read more
o Swollen raised small spot with a rash, o Rash Spread from the size of a 50 cent piece to about 8 ? 10? o Location was very hot o Tightness around the area o Walking ? off balance o Rise in Blood Pressure Treatment: Ice, benadryl, Cortizone 10 cream
71 2021-03-08 chest discomfort Nurse notified by client At Approximately 9:25 or 9:30 Client taken to private area for further eval... Read more
Nurse notified by client At Approximately 9:25 or 9:30 Client taken to private area for further evaluation by EMT EMT present Client?s husband present Client reports light-headedness, tightness and pressure in her chest, and Shortness of breath At 9:33 Vitals taken : O Sat 97, manual BP 170/120, Pulse 95 At 9:36 Vitals taken: Pulse 104, O Sat 96 Client reports pressure in her chest and tightness Client?s husband reports that this happens at home when she is excited and he states she was nervous today about receiving the vaccine. Client was advised to be transported or to at least have the ambulance paramedics perform a EKG to monitor her heart Client did not want to be transported or assessed by the ambulance paramedics EMT informed client of the risk of heart attack and stroke Client continued to decline transport or ambulance arrival At 9:40 Vitals taken: Manual BP 160/110 Client offered water At 9:43 EMT administered one Nitroglycerin 0.4mg tablet sublingually Client felt an immediate headache which subsided afterwards Vitals taken: Pulse 91, O Sat 97 EMT discussed selfcare regarding the Nitroglycerin she keeps at home and when and how to use it more effectively At 9:48 Vitals taken: Manuel BP 150/110 Client reports the tightness and pressure is lessening No longer light-headed or dizziness Client reports past history of light-headedness with hypertension and using Nitroglycerin as needed sometimes quite frequently Client states she took one Nitroglycerin 2 to 3 weeks ago At 9:54 Vitals taken: Right arm Manuel BP 170/110 , Left arm Manual BP 170/110, Pulse 90, O Sat 97 At 10:05 EMT called and arranged to a firetruck crew on Special duty detail come to assess Client with a EKG/heart monitor since the client voiced concerns about being unable to pay for an ambulance or possible transport At 10:07 Manual BP 170/100, Pulse 88, O Sat 97 Client reports feeling lighter in her chest with no pressure in her chest She knows this because she states that she now no longer has difficulty breathing like before when she was first assessed At 10:16 Client reports that her blood pressure medication dosages were changed yesterday She recently had a doctor?s visit EMT educate client on the need to check her BP and keep records for her physician Client reports she was worked up about coming today to receive the vaccine and did not sleep well last night At 10:23 Firearm arrive on site At 10:26 Vitals taken via monitor by firemen BP 176/122, Pulse 90 Client reports to firemen that she was not nervous about the vaccine today. EKG / Heart monitor applied At 10:34 Normal Sinus rhythm reported Firemen states heart monitor reading looks good however Firemen and EMT advised that she follow up with her physician if she decided not to be transported. Firemen and EMT advised that she go to the hospital but that it was her choice to refuse At 10:37 Client refused to be transported Client signed and agreed to the statement : Client informed of the risks of Heart attack and stroke. Client refused to be transported after EKG/heart monitor reading Client feels well enough to leave Client assisted to the car using a wheelchair and her husband will drive her home
71 2021-03-10 chest pain Red over injection site that spread, intense itching over entire body, elevated temp, chest pain sw... Read more
Red over injection site that spread, intense itching over entire body, elevated temp, chest pain sweats, candida infection in groin, Used benedryl and oxygen already in home and soda baths, meds listed on usually used medications. Lasted for 5 days with gradual relief.
71 2021-03-11 heart rate increased, blood pressure increased, blood vessels inflammation Pt got her first dose of Moderna covid vaccine on 3-3-21 at 3:45pm - was fine at pharmacy and waited... Read more
Pt got her first dose of Moderna covid vaccine on 3-3-21 at 3:45pm - was fine at pharmacy and waited 15 mins, then went to the next store and started to feel unwell, her bp was high after with high pulse, is now sick with sinus congestion, flu symptoms, and fatigue. She is now having incontinence issues after the vaccine as well, is on medication that was working just fine prior. Pt now has swelling, redness, and blood vessel flare ups in her left ankle that hasn't occurred in a long time. Feels like the vaccine has exasperated some of her medical conditions.
71 2021-03-11 hypertension 3/6/21 Chief Complaint Patient presents with ? Hypertension ? Headache HPI Patient is a 71 y.o. f... Read more
3/6/21 Chief Complaint Patient presents with ? Hypertension ? Headache HPI Patient is a 71 y.o. female who presents with complaints of high blood pressure and headache reports her blood pressures been high over 200 and his headache in the front of her head moderate sharp better with rest worse with movement ongoing now for the past few hours 3/7/21 Chief Complaint Patient presents with ? Hypertension ? Nausea HPI Patient is a 71 y.o. female who presents with complaint of neck pain that has been going on for 1 year and radiating to the back of the head. Pain is sharp and makes it impossible for her to sleep at night. Patient also complained of migraine headache that is throbbing and bitemporal worsened by light and noise. Patient was seen in this ER yesterday and CT of the head showed right maxillary sinusitis and C-spine showed multilevel degenerative disease. Patient also has elevated blood pressure 180/100 mmHg this morning and this may be due to pain. Patient returned today because she has not felt any better and the pharmacies are not open because of we can not. No fever or chills, no chest pain, no abdominal pain and no vomiting but has nausea.
71 2021-03-11 fainting 8 am the following morning after the vaccine, I became very flushed and hot and don't remember leavi... Read more
8 am the following morning after the vaccine, I became very flushed and hot and don't remember leaving my seat at the breakfast table. I found myself on the floor on the other side of the table. I had fainted which has never happened to me in my lifetime. I was drenched in sweat, and nauseous, and a headache began and lasted the day. I spent the day resting and was fine the following day. I do have an occasional hot flash, even at 71 years old. I was alert, oriented, and had a bruise on my shoulder. I had now reoccurring issues .
71 2021-03-12 fainting, pulmonary embolism Pulmonary embolism, Patient began becoming short of breath shortly after receiving her first vaccine... Read more
Pulmonary embolism, Patient began becoming short of breath shortly after receiving her first vaccine, and then became worse with her second one. She presented with syncope and was found to have multilobar embolic burden as noted above with evidence of right-sided heart strain
71 2021-03-13 heart rate increased, hypertension Patient was seated for approximately 10 minutes post-vaccination when she alerted the technician tha... Read more
Patient was seated for approximately 10 minutes post-vaccination when she alerted the technician that she was not feeling well. I approached patient and asked her to describe her symptoms. She reported feeling "weird" near and around her mouth. Her heart was racing and she was feeling very anxious - similar to the sensation of a panic attack which she has a history of experiencing. I took her blood pressure and it was reported at 197/120. Due to the high blood pressure and signs of potential allergic reaction I called 911 immediately. Medical services arrived and provided medical care and took her to nearest hospital. The only known thing to have been provided to the patient was an injectable diphenhydramine and EMS did report that she was getting a rash on her stomach by the time they arrived and decided to transport her.
71 2021-03-13 blood clot On day 5 after injection, patient developed right inner thigh discomfort, leg swelling and accentuat... Read more
On day 5 after injection, patient developed right inner thigh discomfort, leg swelling and accentuation of existing varicose veins.
71 2021-03-14 heart rate increased pain above kidneys, tiredness, rapid heartbeat, itchiness, extreme fatigue (felt like it must feel ... Read more
pain above kidneys, tiredness, rapid heartbeat, itchiness, extreme fatigue (felt like it must feel to be drugged), inability to stay awake, fever 102.7; penetrating chills, headache, loss of voice, dizziness, swollen lymph glands, weakness, excessive sleep,
71 2021-03-14 palpitations Patient received her dose in her left arm and was seated and comfortable prior to receiving the shot... Read more
Patient received her dose in her left arm and was seated and comfortable prior to receiving the shot. Patient was being treated with antibiotics for a tooth infection and asked if there were any problems with getting the shot. The vaccinator explained there was no interaction or contraindication. Patient consented to vaccine and was reminded of possible side effects. Within under a minute she complained of heart racing, redness on throat and back of neck. Patient was able to speak, never lost consciousness and answered questions appropriately. 911 was called when patient continued complaining of rapid heart rate and pain in her right arm, not the arm she received the vaccine. Vaccinator supported patient while sitting until EMT arrived, then she was transported to Hospital for assessment.
71 2021-03-15 deep vein blood clot RLE DVT
71 2021-03-15 heart rate decreased, hypotension Shaking, weakness, fingers tingling, throat tightness, drop in pulse and blood pressure, chills happ... Read more
Shaking, weakness, fingers tingling, throat tightness, drop in pulse and blood pressure, chills happened 20 minutes after vaccine that got better in two hours. The next 10 days pounding headache,
71 2021-03-15 heart attack, hypertension Got heart attack; High blood pressure; Shortness of breath; Hip is paining; A spontaneous report was... Read more
Got heart attack; High blood pressure; Shortness of breath; Hip is paining; A spontaneous report was received from a consumer (Patient's husband) concerning a 71-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart attack, high blood pressure, pain in hip and shortness of breath. The patient's medical history included three by-pass (open) heart surgery in 2020. No relevant concomitant medications were reported. On 25 Feb 2021 Thursday, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 014M20A) intramuscularly for prophylaxis of COVID-19 infection. On 25 Feb 2021, Thursday night, the patient experienced high blood pressure of 189/101 and got a heart attack followed by shortness of breath and the patient hospitalized on 25 Feb 2021 Thursday night. On 26 Feb 2021, Friday at 04:00 PM, the patient was discharged from hospital. The patient experienced hip pain and little high blood pressure than normal. Laboratory details included blood work normal and high blood pressure, 189/101. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, heart attack pain in hip and shortness of breath was not reported. The outcome for event high blood pressure was considered resolving.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: MOD21-043135:Same reporter
71 2021-03-15 oxygen saturation decreased, blood glucose increased, low blood oxigenation HOSPITALIST HISTORY AND PHYSICAL DATE OF ADMISSION: 3/15/2021 DATE OF H&P: 3/16/2021 PATIENT D... Read more
HOSPITALIST HISTORY AND PHYSICAL DATE OF ADMISSION: 3/15/2021 DATE OF H&P: 3/16/2021 PATIENT DEMOGRAPHIC: 71 year-old female MODE OF ARRIVAL: EMS. _____________________________________________________________ CHIEF COMPLAINT: Dyspnea and mild cough. HISTORY OF PRESENT ILLNESS: 71 year-old T2 diabetic female who presented to the ED late yesterday for evaluation of increasing shortness of breath. Also, reports she's had a nonproductive cough for several days. Yesterday, her breathing just sufficiently severe that she could not walk through the house without stopping to catch her breath. No chest pain. She ultimately decided to summon EMS. They reported that her initial SaO2 values to be in the low to mid 80% range. She was placed on 2 L/min of supplemental oxygen and given a SABA updraft in route. When she arrived at the ED, her SaO2 registered 92%. She denies any prior history of asthma or COPD. No ischemic or valvular heart disease. No history of CHF. No orthopnea. No pedal edema. No high fever. Of note, she completed her second COVID19 vaccination approximately 10 days prior to onset of her chief symptoms as described. In the ED, her chest x-ray was felt to show no evidence of acute cardiopulmonary disease. Her d-dimer was normal. However, a CTA of the chest revealed extensive centrilobular ground-glass nodularity throughout the lungs. No pulmonary embolus or signs of right heart strain. Patient admitted with atypical pneumonia/pneumonitis and associated dyspnea, cough and hypoxemia. ASSESSMENT: 71-year-old T2 diabetic with hypertension presents with increasing shortness of breath and nonproductive cough, onset approximately 10 days post second COVID-19 vaccination. CTA of chest reveals an atypical pattern of extensive centrilobular ground glass nodularity. Clinically she has associated mild bronchospasm and hypoxemia.
71 2021-03-17 heart rate irregular Irregular heartbeat
71 2021-03-18 loss of consciousness Received the vaccine, and at 3:00 to 4:00 her left arm felt like it was in a vice, being squeezed ti... Read more
Received the vaccine, and at 3:00 to 4:00 her left arm felt like it was in a vice, being squeezed tighter and tighter, and could not lift or move her arm. Took Tylenol which did not improve any symptoms. Got headache and had that with the arm in the pain all night long. Woke up totally drenched by sweating, and went to the bathroom and felt dizzy yelled for her husband and passed out, and her husband caught her while passing out and woke up on the floor. On the Thursday she was in her recliner the entire day, had nausea, fever, chills, headache, continued with the pain of the arm in a vice, which lasted all day long. Her husband forced crackers and water down her as she had no appetite either for 3 days. She felt so fatigued and her head was not clear. She slowly gradually improved, and yesterday 3/18/21 she feels her head fogginess has improved, and her arm is gone as she has been exercising with a band. It is a little sore but otherwise fine. The excruciating pain lasted for 2 full days. She put some Lidocaine and it possibly helped. She called her doctor and they told her to exercise the arm, and to take more Tylenol, which she had tried which did not improve anything.
71 2021-03-19 palpitations, blood pressure increased Dizziness, extremely high blood pressure, heart palpitations EKG 12 LEAD-POC
71 2021-03-20 hypotension hypotension and inability to raise left arm for 3 days. She also felt fatigued and had fever to 101... Read more
hypotension and inability to raise left arm for 3 days. She also felt fatigued and had fever to 101 degrees F
71 2021-03-21 blood glucose increased, loss of consciousness passed out, vomiting, diarrhea, high blood sugars, generalized weakness, rash at injection site, hea... Read more
passed out, vomiting, diarrhea, high blood sugars, generalized weakness, rash at injection site, head ache....did not seek treatment. vomiting, diarrhea, fatigue continued for 2-3 days days.
71 2021-03-21 cerebrovascular accident March 6th noticed right hand going numb but cleared up within 10 minutes. March 7th right hand went... Read more
March 6th noticed right hand going numb but cleared up within 10 minutes. March 7th right hand went numb again and had vision problems with right eye, cleared up in about 15 minutes. March 9th right hand and right side of face went numb. Went to hospital and was examined and told I was having a stroke. I was admitted to hospital for two days. MRI showed that I had a stroke and now have some brain tissue damage. I and now going to occupational therapy to regain use of right hand. The Doctors thought that it was pretty coincidental that my first stroke symptom (transient numb right hand on the 6th) started just a couple days after I got the second dose of the moderna vaccine.
71 2021-03-21 chest pain Chest pains shortness of breath, headache, backpain and coughing.
71 2021-03-21 heart rate increased Headaches, muscle aches, racing pulse, nausea, chills, temp of 101.7
71 2021-03-22 blood pressure increased Elevated blood pressure, 160 despite doubling dose of BP medicine, after 2 weeks (March 5) Headache ... Read more
Elevated blood pressure, 160 despite doubling dose of BP medicine, after 2 weeks (March 5) Headache Extreme joint pain which lasted 1 week, has resolved Taking tylenol for pain
71 2021-03-22 deep vein blood clot, loss of consciousness, pulmonary embolism Patient experienced severe nausea and dizziness in the evening on 3/9/21 and lost consciousness in h... Read more
Patient experienced severe nausea and dizziness in the evening on 3/9/21 and lost consciousness in her kitchen. She was taken to the ER the next morning and was diagnosed with a pulmonary embolism and acute DVT in the right popliteal vein and right calf veins. Patient was treated with EKOS and discharged on 3/13/21 on Apixiban.
71 2021-03-23 blood pressure decreased, anaemia I felt fine at first and it lasted until I stared coughing Saturday (1/16), I thought it was just po... Read more
I felt fine at first and it lasted until I stared coughing Saturday (1/16), I thought it was just post-nasal drip. By Monday (1/18), I had a really bad sore throat, chills and a fever. I had a fever for 26 solid days. My lung capacity was 98-99% the entire time. On Wednesday (1/20), I contacted my doctor and he had me to come in to get tested for COVID. The next day, I got my results and they were positive. It got worse from there and I was admitted to the hospital due to my sodium being low. I was also losing a lot of weight. I was hospitalized for 3 days in order for them to get my sodium up. I also had burning and tingling on the sole of my feet, which they attributed to my lack of sodium. My symptoms lasted for weeks. I have a lot of congestion, but they can't seem to locate the source. I'm also having issues with my BP, which just started to decrease on 3/21. I was also diagnosed as anemic, which I've never had an issue with. I also have a hard time concentrating. I also have spine issues, so I'm not sure if my knee pain is from that or the COVID.
71 2021-03-23 blood pressure increased Severe headache started the next day and lasted 3 weeks. Then started up again after 2nd vaccine o... Read more
Severe headache started the next day and lasted 3 weeks. Then started up again after 2nd vaccine on 3/12/21. Second session has not been as severe or prolonged. Blood pressure elevated and erratic. Still happening after 2nd vaccine on 3/12/21 and finally stabilizing a bit. Soreness in left arm started that night but went away in a couple days. Tiredness and fatigue every day.
71 2021-03-23 loss of consciousness, blood pressure increased, fainting, lightheadedness Syncope; things went dark; almost passed out twice; BP spikes; left arm pain at the site of the inje... Read more
Syncope; things went dark; almost passed out twice; BP spikes; left arm pain at the site of the injection; fatigue; A spontaneous report was received from a Consumer concerning a – 71 Years-old female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced almost fainted/presyncope, Fainting/Syncope, Blackout/Loss of consciousness, Injection site pain, BP spikes and Fatigue. The patient's medical history was provided as Atrial Fibrillation, Syncope and Diabetes (borderline). Relevant concomitant medications were reported as Warfarin, Cimetidine, Carvedilol, Spironolactone, Glipizide, Magnesium, MiraLAX, Probiotics, Stool softener and Clonidine PRN. On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route in the left arm for prophylaxis of COVID-19 infection. On 26 Feb 2021, after receiving the first Moderna Covid -19 Vaccine the patient experienced dizziness, increased heart rate, left arm pain at injection site. She reported of "almost passed out, and things went dark" on day 4 (02FEB2021) and day 5 (03FEB2021) after the vaccination. She reported that she had one syncopal episode 02FEB2021 while she was standing around the stove, and 2nd syncopal episode occurred on 03FEB2021 while she was getting out of shower. She also has mild fatigue since the vaccination. Fainting and Blackout were medically significant. Laboratory details were provided by her BP readings which are as follows: BP reading on 02MAR2021 -- 102/56, 168/69, 103/54 BP reading on 03MAR2021 -- 180/90, 193/75, 201/91, 215/115 (took Clonidine) BP reading on 04MAR2021 -- 176/81, 200/87 BP reading on 06MAR2021 -- 200/90, 220/92 (took Clonidine) She checked her blood glucose levels daily, and its "within normal" limits. Treatment details was provided as Clonidine PRN. Action taken with mRNA-1273 in response to the events was unknown. On unspecified date, the outcome of the events injection site pain was Recovered/Resolved. At the time of this report the outcome of the events Fainting, Blackout and Fatigue were unknown.; Reporter's Comments: Based on the information provided, the established safety profile of mRNA-1273 vaccine and a strong temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. Injection site pain and Fatigue are consistent with the safety profile of the vaccine.
71 2021-03-23 blood clot On March 6, I woke up feeling like I had a Charlie horse in my left calf. I tried to walk and it was... Read more
On March 6, I woke up feeling like I had a Charlie horse in my left calf. I tried to walk and it was sore but I felt it would go away in a day or two. By Wednesday, March 10, I called my doctor and after telling them my left calf hurt , they had me come right in. After seeing dr I was sent to get a sonogram immediately and was told I had a blood clot inside my left knee. I was sent back to Dr and was given Xerelto 15 mg twice a day for 21 days and the 20 mg once a day until gone. Today,, it is still sore. I am asking if I should take my second shot on March 29 or not.
71 2021-03-24 deep vein blood clot Clot on the lower left leg; foot and ankle swollen; A spontaneous report was received from a physici... Read more
Clot on the lower left leg; foot and ankle swollen; A spontaneous report was received from a physician concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced foot and ankle swelling (joint swelling) and clot on the lower left leg (deep vein thrombosis). The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination. On 5 Feb 2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) via intramuscular route on left side for prophylaxis of COVID-19 infection. On 5 Mar 2021 prior to the onset of the events, the patient received their second planned dose of mRNA-1273 (Lot number: 036A21A ) via intramuscular route on left side for prophylaxis of COVID-19 infection. Doctor found a clot in her lower left leg. Patient said that on Feb 2 before receiving the first dose on Feb 5 needed to have an x ray and blood work due to foot and ankle got swollen. Patient said they checked it for different things and that the doctor thought It would be a pseudo gout. As the ankle was still swollen patient went to her family doctor and doctor insisted to have a test for deep vein thrombosis. They have found a clot on the lower left leg. The patient had stated she have not a had a surgery or an injury and that it happened between doses. Treatment drug used for the event included was apixaban. Action taken with mRNA-1273 in response to the events was not applicable. The outcome for the events, foot and ankle swelling and clot on the lower left leg, was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. It was reported that the patient had an x ray and blood work due to foot and ankle swelling before receiving the first dose of vaccine and that the doctor thought it to be a pseudo gout.
71 2021-03-24 transient ischaemic attack Mini stroke thing; Hot; 15-20 sec she had hard time talking; Mumbling; Fatigue; Chills; A spontaneou... Read more
Mini stroke thing; Hot; 15-20 sec she had hard time talking; Mumbling; Fatigue; Chills; A spontaneous report was received from a consumer concerning his wife a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, hot/ feeling hot, chills and for 15-20 sec she had hard time talking/ dysarthria, mumbling/ speech disorder, like mini stroke thing/ transient ischaemic attack. The patient's medical history included high blood pressure. Concomitant medications included pill for high blood pressure. On 08 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly in the left arm (non-dominant) for prophylaxis of COVID-19 infection. On 08 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08 Mar 2021, on the same night the patient experienced felt fatigue, hot, chills and for 15-20 sec the patient had hard time talking, mumbling, like mini stroke thing a medically significant event. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of the events, fatigue, hot, chills and for 15-20 sec she had hard time talking, mumbling, like mini stroke thing was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The patient's medical history of high blood pressure is a risk factor for stroke and hence remains a confounder for causality. The patient did not consent for the follow up.
71 2021-03-24 blood vessels inflammation Inflammatory vasculitis bilateral fingers
71 2021-03-25 blood pressure increased I estimate the date reaction began. But around that time I began having high blood pressure even tho... Read more
I estimate the date reaction began. But around that time I began having high blood pressure even though I was on 10mg of Lisinopril. Still ongoing now even though my doctor doubled the lisinopril, and last week changed med to Losarton 50 mg. Now this week this is doubled to 100 mg. I never had this much high bp before. Maybe it was the Moderna. I do not know what has caused it.
71 2021-03-25 pallor Patient complained of swollen tongue, dizzyness, nausea 5-10 min after vaccination. Pt was noted to... Read more
Patient complained of swollen tongue, dizzyness, nausea 5-10 min after vaccination. Pt was noted to look pale and ? sl swollen tongue. BP with wrist cuff not attainable, pulse 100+ and oxygen sat 98% iniitally. Request for ambulance made. Pt was placed supine, feet raised. Pt was recurrently assessed by MD on site as well as RN and Paramedics. Pt felt nauseated. Tongue not def swollen? lips not swollen, no respiratory distress. IM benadry 50 mg given. Pt felt better 5 minutes after benadryl. BP when supine was elevated, HR in low 100s and sats remained good. Pt was then transported to local emergency room.
71 2021-03-25 palpitations, heart rate irregular, atrial fibrillation 1./25/21 Racing heartbeat 5 minutes after vaccine lasted about 10 minutes 1/31/21 -2/1/21 Palpitat... Read more
1./25/21 Racing heartbeat 5 minutes after vaccine lasted about 10 minutes 1/31/21 -2/1/21 Palpitations and erratic heartbeat continuous and lasted about 14 hours then became intermitent. Cardiologist was seen on 2/2/21. Wore heart monitor for about 8 days. DX: Afib 2/20/21 awoke at 6:00 am. The room was spinning, I became nauseous, had dry heaves and my legs began shaking uncontrollably. 911 was called and I was transported to the ER. A CT scan, chest xray, blood test, and urinalysis was performed. DX: dehydration. I was given meds for nausea and bactrim for a slight UTI (although I had no symptoms.
71 2021-03-26 pulmonary embolism Acute Submassive Pulmonary embolism B/L
71 2021-03-26 fainting Moderna Lot #001B21A. Given 3/16/2021 Pain & bruising at site Within 5 days felt weird, low blood s... Read more
Moderna Lot #001B21A. Given 3/16/2021 Pain & bruising at site Within 5 days felt weird, low blood sugar, Headache Unwell, joint aches, pain, muscle pain, weak, Wednesday 24th during the night nauseated, vomited several times came in waves hot sweaty fainted for a few seconds x 2 March 27th still feel weak, joint pains fuzzy in the head, gradually getting better but not well yet. Yellow fading bruise at site. I emailed Dr to notify him just in case it was related to the vaccine
71 2021-03-28 anaemia, low platelet count Thrombocytopenia (CMS/HCC) Hypercalcemia Chronic anemia AKI (acute kidney injury) (CMS/HCC) DKA, typ... Read more
Thrombocytopenia (CMS/HCC) Hypercalcemia Chronic anemia AKI (acute kidney injury) (CMS/HCC) DKA, type 2 (CMS/HCC)
71 2021-03-28 chest discomfort Patient started to feel SOB, Chest tightness, mouth swelling, and generalized rash. Vitals taken, ac... Read more
Patient started to feel SOB, Chest tightness, mouth swelling, and generalized rash. Vitals taken, accessed by provider. Benadryl 25 mg IM ordered and administered. patient quickly started to feel better. subsequent vitals showed stable, SOB, chest tightness and mouth swelling diminished. Patient reassessed by provider. Discharged home
71 2021-03-28 heart rate increased, palpitations rapid heart rate, pounding heart, weakness. Lasted 1 hour.
71 2021-03-29 hypertension - Large swelling at injection site. 1-1/2 inches high, 4-5" long and wide within 12 hours -Swollen ... Read more
- Large swelling at injection site. 1-1/2 inches high, 4-5" long and wide within 12 hours -Swollen and black and blue eye lid that hung down over eye within 12 hours -Flushing and red patchiness on both arms and hands from shoulder through tip of fingers with 24 hour with above symptoms. They put me on a steroid -Severe flushing on face and eye lids 2 days injection and continuing now into day three after injection along with high blood pressure up to 203/114
71 2021-03-30 loss of consciousness warm to touch; Red cheeks; almost flu like symptoms; sick; knocked out; Fever of 102 F; delayed cuta... Read more
warm to touch; Red cheeks; almost flu like symptoms; sick; knocked out; Fever of 102 F; delayed cutaneous hypersensitive arm; sore; itching; covid arm; red at injection site; A spontaneous report was received from a consumer concerning 71year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed redness/erythema , warm to touch/feeling hot, cutaneous hypersensitive arm/cutaneous sympoms, injection site was red/ vaccination site erythema, hot, sore/pain and itching/pruritus, like COVID arm/vaccination site reaction. After the second shot of vaccine she got sick/sickness, fever of 102 F/pyrexia, flu like symptoms/influenza like illness and was knocked out/loss of consciousness. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) on 19 Jan 2021. On 21 Feb 2021, approximately on the same day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Consumer had reported that 12 days after receiving the first dose, patient experienced delayed cutaneous hypersensitive arm. Arm was red at injection site, which later spread to whole upper arm. The injection site was re, hot, sore, itchy like COVID arm. Which was resolved later, and she had taken diphenhydramine for it. After receiving her second dose of vaccine she got sick, fever of 102 F, knocked out, almost flu like symptoms. which lasted for couple of days and was resolved on 23 Feb 2021. For which she had taken acetaminophen for it. Also, she had red cheeks, warm to touch for last few days, almost 2 weeks after her 2nd dose of vaccine. Treatment for the event included diphenhydramine and acetaminophen. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events, redness, warm to touch, cutaneous hypersensitive arm, injection site was red, hot, sore and itchy like COVID arm were considered resolved and for she got sick, fever of 102 F, knocked out and flu like symptoms was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
71 2021-03-30 fainting Fainted; Vomited; Ringing in ears; Injection site was slightly sore; Sore throat; Hoarseness; Dry ey... Read more
Fainted; Vomited; Ringing in ears; Injection site was slightly sore; Sore throat; Hoarseness; Dry eyes; A spontaneous report was received from a consumer, concerning herself a 71 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fainted/Syncope, Vomiting, Ringing in ears/, injection site was slightly sore/Vaccination site pain, Sore throat, Hoarseness, Dry eyes. The patient's medical history was not provided, concomitant medication was not provided by reporter. On 14Jan2021, prior to the onset of events patient received her first dose of two planned doses of mRNA-1273 (lot number: 028L20A) via unknown route on right arm for COVID-19 infection prophylaxis. On 15 Jan 2021 she experienced fainted, She was taken to the Emergency Room by ambulance. She was vomiting in route to the hospital. She also complained that she had ringing in her ears, & admits that she still had it. At the hospital, they performed a CAT scan & a MRI of her "stomach." They wanted to admit her, but she was fearful she would contract Covid during her hospital stay. The injection site was slightly sore. She admits she developed a sore throat & hoarseness that day, & has I've had it since then. On 01March 2021, her eye Dr diagnosed her with dry eyes. The seriousness for fainted, Vomiting, Ringing in ears, injection site was slightly sore, Sore throat, Hoarseness considered as hospitalization. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, fainted, Vomiting, Ringing in ears, injection site was slightly sore, Sore throat, Hoarseness, Dry eyes was unknown at time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
71 2021-03-31 very slow heart rate heart rate went down to 50 and 49/heart rate was consistently in the low 50s or even below 50; A spo... Read more
heart rate went down to 50 and 49/heart rate was consistently in the low 50s or even below 50; A spontaneous report was received from a consumer concerning a 71 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced low heart rate/bradycardia. The patient's medical history included allergy to sulfa and latex. The patient was taking baby aspirin 81 mg, Simvastatin 20 mg, Ethacrynic acid 25 mg, Benicar 20 mg, Synthroid 100 mcg, Potassium, Ciprofloxacin 500 mg as concomitant medication On 23-Jan-2021, prior to the onset of the events, the patient received their first dose of planned two doses of mRNA-12 intamuscularly for prophylaxis of COVID-19 infection. On 23-Jan-2021, the patient got the shot where my heart rate was consistently in the low 50s or even below 50. No treatment information was given. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event low heart was resolved on 23-Jan-2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
71 2021-03-31 cerebrovascular accident Patient stated she suffered a stroke about 1 week after getting the vaccine. The patient went to the... Read more
Patient stated she suffered a stroke about 1 week after getting the vaccine. The patient went to the hospital and was successfully treated. The patient is now on plavix and pravastatin for further prevention.
71 2021-03-31 palpitations pt states that a couple of hours after taking the vax she started having heart palpitations like her... Read more
pt states that a couple of hours after taking the vax she started having heart palpitations like her heart was pumping very hard and she felt really strange. She went to her PCP on 3/30/2021. They did blood work with pending results and EKG is normal. Pt still has these symptoms with heart palpitations but her bpm is normal. She is concerned about getting 2nd dose.
71 2021-04-01 chest pain 03/31/2021 Three days after vaccine had Sharp pain in left side of chest had to go to urgent care ... Read more
03/31/2021 Three days after vaccine had Sharp pain in left side of chest had to go to urgent care For ct scan of chest last two days
71 2021-04-01 fainting The next morning, I fainted when I got out of bed.
71 2021-04-02 fainting Moderna Covid 19 Vaccine EAU severe flu-like symptoms escalating to incontinence, cumulating in fai... Read more
Moderna Covid 19 Vaccine EAU severe flu-like symptoms escalating to incontinence, cumulating in fainting and being unable to move any body part except one index finger. After that subsided, foggy brain, fever. Eventually a day of diarrea.
71 2021-04-03 blood pressure decreased, hypertension After we left the vaccination site I had chills, severe diarrhea, nausea, extreme fatigue, no appeti... Read more
After we left the vaccination site I had chills, severe diarrhea, nausea, extreme fatigue, no appetite, dehydration These symptoms went on for five days. I did not eat or drink for five days. I continued with extreme diarrhea and slept most of the time. I had no energy. My blood pressure dropped to 68/39 and was sent to the Emergency Room and immediately admitted.
71 2021-04-03 palpitations On the night of the vaccination: 102 degree fever, chills, palpitations, headache, nausea. Fever and... Read more
On the night of the vaccination: 102 degree fever, chills, palpitations, headache, nausea. Fever and chills continued for two days. On 3rd day following vaccination, developed pain on entire inner surface of left arm and trouble focusing eyes including double vision. Arm pain increased on subsequent days. Arm started to swell on 7th day. Woke up on morning of 9th day with entire arm and hand swollen. Range of motion (both flexing and extending arm) became limited due to pain. It is now 21st day. Swelling is decreasing. Still unable to fully flex or extend arm. Vision problems continued.
71 2021-04-04 blood pressure increased Severe headache, nausea, spike in blood pressure, foggy brain
71 2021-04-04 heart rate increased Rapid heartbeat started almost immediately. Subsided in approximately 15-20 minutes.
71 2021-04-05 fainting syncopy , fever , dizziness , body aches
71 2021-04-06 hypertension BODY ACHES, SLIGHT FEVER, HIGHER BLOOD PRESSURE, NAUCIOUS, SLEEPING AND STAYING IN BED FOR 3 DAYS
71 2021-04-06 loss of consciousness Awakened about 3 am and was nauseous. Got up to go to bathroom and passed out. I live alone. Woke up... Read more
Awakened about 3 am and was nauseous. Got up to go to bathroom and passed out. I live alone. Woke up on floor. Went back to bed and in the morning there was blood on my pillow from gashes in my head. Apparently pulled something in my chest as I fell.
71 2021-04-07 chest pain Patient received her Moderna vaccine. She waited the 15 minutes and went around the store to shop. S... Read more
Patient received her Moderna vaccine. She waited the 15 minutes and went around the store to shop. She then started to feel sharp chest pain and shortness of breath and returned to pharmacy. Patient did not report swelling in the airways, was able to breathe however with some difficulty. Patient reported having history of asthma and high cholesterol when asked. With patients consent, took patients blood pressure and the reading was 130/87. Told daughter what was going on, most likely not an allergic reaction/anaphylaxis. Patient then started to have "pseudo-seizures." Asked daughter and patient if we can call ambulance, and they both agreed. Stood by patient in post-vaccination area waiting for ambulance. Patient was still able to breath and her chest pain has decreased per patient - said pain lessened when sitting down. Ambulance arrived and took patient away. Both daughter and patient thanked pharmacy for helping and taking care of patient.
71 2021-04-08 cerebrovascular accident, transient ischaemic attack, blood pressure fluctuation Pt has Moderna Covid shot number one. Within a week she started haveing swings in her Blood pressu... Read more
Pt has Moderna Covid shot number one. Within a week she started haveing swings in her Blood pressure some times associated with numbness sensation left face, arm and left lower extremity. I saw her on March 27 with the same. Neg CT work up, including neg CT angio gram of head and neck. I transfered pt for insurance reasons. I called and spoke with her daughter on April 2. Pt was having same symptoms, although improved. I ask about MRI. She was told that there may or may not have been a stroke on that study. . My impression was CVA with subjective left sided parestesia or TIA.
71 2021-04-08 loss of consciousness Received Moderna vaccine from Medical Group on 03/26/2021-2nd dose. Reports that about 5:30am on 03/... Read more
Received Moderna vaccine from Medical Group on 03/26/2021-2nd dose. Reports that about 5:30am on 03/27/2021 she began to have chills, weakness. States she eventually passed out, falling on the floor in which she does not remember, breaking her ankle. Ankle repair required surgical interventions. She is now back home wearing a cast to affected foot.
71 2021-04-11 chest pain, pulmonary embolism right sided pleuritic chest pain started 04/11/2021.
71 2021-04-11 coughing up blood Patient was vaccinated at Pharmacy with 2nd dose Moderna 03/28/2021, patient called dialysis clinic ... Read more
Patient was vaccinated at Pharmacy with 2nd dose Moderna 03/28/2021, patient called dialysis clinic that she was coughing up blood and she is going to Hospital in the afternoon. Pt's daughter called the clinic informed staff that pt passed away 4/3/2021 due to internal bleeding.
71 2021-04-11 palpitations about a half hour after getting the vax she became light headed, had nausea, some chills. By the ti... Read more
about a half hour after getting the vax she became light headed, had nausea, some chills. By the time she got home she was very dizzy and almost fainting. She said her heart was racing and pounding then she vomiting. These symptoms lasted a couple of hours before dissipating.
71 2021-04-12 loss of consciousness Chills with shaking , the next morning my husband found me passed out on the tile floor,bruised ribs
71 2021-04-12 platelet count decreased Approximately 12 days after 2nd dose of Moderna vaccine was given, patient was found down on floor a... Read more
Approximately 12 days after 2nd dose of Moderna vaccine was given, patient was found down on floor around 01:30 a.m. by husband. Husband states she was unable to move her left side and had slurred speech. Patient was brought to Hospital by EMS. Upon arrival she was unable to move her left side and is drowsy. She is oriented and complains of left sided headache. Stroke protocol was initiated. After stroke work up, patient was transferred by another Hospital.
71 2021-04-12 pulmonary embolism On 1-27-21 my mother received her first dose of the Moderna COVID-19 vaccine (031L2A). The next day ... Read more
On 1-27-21 my mother received her first dose of the Moderna COVID-19 vaccine (031L2A). The next day she felt something in the back of her left knee. The following day (2 days) after the injection she saw her primary care physician for the discomfort in the back of her knee. She was treated for what was believed to be a soft tissue injury. She received her second dose of the Moderna COVID-19 (14M20A) vaccine on Friday 2-26-21. The next day the back of her knee started to bother her again. She saw her doctor on Monday3-1-21 and had an x-ray. On Tuesday the doctor's office called and said her x-ray was clear. Friday morning, 3-5-21 my father heard a loud noise (thud) and found my mother unresponsive on the bathroom floor at approximately 8:30am. He called 911. She was transported to the hospital via ambulance. The emergency room physicians worked on her for over an hour and were unable to get her back. Her time of death was 10:12am. The primary cause of death listed on her death certificate is pulmonary embolism.
71 2021-04-12 blood clot Seven days after Moderna vaccine I got up and started feeling a warmth in my leg that started in foo... Read more
Seven days after Moderna vaccine I got up and started feeling a warmth in my leg that started in foot and went up and it started hurting really bad, called an ambulance and went to hospital and because of blood clots, I had to have emergency surgery, it was very huge arterial clot, and developed shingles as well.
71 2021-04-13 heart rate increased, palpitations Arm was sore. Went to sleep about 11pm woke up at 2 AM could not go back to sleep. Mind racing . Bo... Read more
Arm was sore. Went to sleep about 11pm woke up at 2 AM could not go back to sleep. Mind racing . Body aches. Heart racing. Got up temp about 100.7 all day. Heart rate elevated. All lasted about 1 day. Except arm sore for about 5 days.
71 2021-04-13 loss of consciousness, nosebleed Passed out; Hit her head 3 times; White Blood Cell Increased; Bloody nose that would not stop; Felt ... Read more
Passed out; Hit her head 3 times; White Blood Cell Increased; Bloody nose that would not stop; Felt nauseated; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and HEAD INJURY (Hit her head 3 times) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Diabetes since an unknown date. Concomitant products included POTASSIUM, VITAMIN D3, TRAMADOL, LEVOTHYROXINE, METOLAZONE, SPIRONOLACTONE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion hospitalization), HEAD INJURY (Hit her head 3 times) (seriousness criterion hospitalization), EPISTAXIS (Bloody nose that would not stop) and NAUSEA (Felt nauseated). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (White Blood Cell Increased). The patient was hospitalized from 17-Mar-2021 to 24-Mar-2021 due to HEAD INJURY and LOSS OF CONSCIOUSNESS. On 17-Mar-2021, LOSS OF CONSCIOUSNESS (Passed out), HEAD INJURY (Hit her head 3 times), EPISTAXIS (Bloody nose that would not stop) and NAUSEA (Felt nauseated) had resolved. At the time of the report, WHITE BLOOD CELL COUNT INCREASED (White Blood Cell Increased) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not Applicable. After hospitalization patient was started with Januvia, Pregabalin, Potassium chloride, Torsemibe, Metoprolol, Levemir insulin Company comment:Based on the current available information and the temporal association between the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product and the start date of the events a causal relationship cannot be excluded.
71 2021-04-15 cerebrovascular accident Stroke due to a blood clot on the left side of my brain; had a dizzy spell; felt very tired; This sp... Read more
Stroke due to a blood clot on the left side of my brain; had a dizzy spell; felt very tired; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke due to a blood clot on the left side of my brain) in a 71-year-old female patient who COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 02-Mar-2021, the patient received first dose (Intramuscular) at an unspecified dose. On 05-Mar-2021, the patient experienced DIZZINESS (had a dizzy spell) and FATIGUE (felt very tired). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke due to a blood clot on the left side of my brain) (seriousness criteria medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke due to a blood clot on the left side of my brain), DIZZINESS (had a dizzy spell) and FATIGUE (felt very tired) outcome was unknown. No concomitant medications were reported. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.
71 2021-04-15 deep vein blood clot large RUE DVT
71 2021-04-15 loss of consciousness passed out; woke up the next day, caller said she did not remember anything of what happened; hallo ... Read more
passed out; woke up the next day, caller said she did not remember anything of what happened; hallo feeling in the top of my head/funny feeling; Ended up in the floor/ fall down on the floor and her roommate found her and put her into bed; like a short neckless, red round in the top right of my head, that symptom lasted the whole; Chills; sore left arm for 2 or 3 days; This case was received via an unknown source on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). Concomitant products included TIZANIDINE, SERTRALINE, FUROSEMIDE, ATENOLOL, CLONIDINE, GABAPENTIN, COLESTIPOL and VALSARTAN for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MEMORY IMPAIRMENT (woke up the next day, caller said she did not remember anything of what happened), FEELING ABNORMAL (hallo feeling in the top of my head/funny feeling), FALL (Ended up in the floor/ fall down on the floor and her roommate found her and put her into bed), ERYTHEMA (like a short neckless, red round in the top right of my head, that symptom lasted the whole), CHILLS (Chills) and VACCINATION SITE PAIN (sore left arm for 2 or 3 days). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), MEMORY IMPAIRMENT (woke up the next day, caller said she did not remember anything of what happened), FALL (Ended up in the floor/ fall down on the floor and her roommate found her and put her into bed), ERYTHEMA (like a short neckless, red round in the top right of my head, that symptom lasted the whole), CHILLS (Chills) and VACCINATION SITE PAIN (sore left arm for 2 or 3 days) outcome was unknown and FEELING ABNORMAL (hallo feeling in the top of my head/funny feeling) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. 2nd dose scheduled on 05Apr2021. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's advanced age along with concomitant medications may have been contributory for the occurrence of the events. Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's advanced age along with concomitant medications may have been contributory for the occurrence of the events.
71 2021-04-15 transient ischaemic attack TIA (small stroke); This spontaneous case was reported by a nurse (subsequently medically confirmed)... Read more
TIA (small stroke); This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA (small stroke)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L02A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA (small stroke)) (seriousness criterion hospitalization). The patient was hospitalized on 05-Jan-2021 due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA (small stroke)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information included she was currently under medical examination for the causes and treatment of the stroke. Based on the current available information and temporal association between the use of the product and the onset date of the reported event of TIA, a causal relationship cannot be excluded. This case was linked to MOD-2021-066107 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of TIA, a causal relationship cannot be excluded.
71 2021-04-16 chest discomfort Chill, Fever (100.8) for 2.5 days, Nausea and episodes of violent vomiting for 3 hours overnight af... Read more
Chill, Fever (100.8) for 2.5 days, Nausea and episodes of violent vomiting for 3 hours overnight after shot, episodes of sweating for 5 days, malaise for 5 days. Pressure in chest when resumption of walking routine after the 4th day.
71 2021-04-17 hypertension sore arm next day. severe leg pain several days later. shaking / tremor a week after. trouble writi... Read more
sore arm next day. severe leg pain several days later. shaking / tremor a week after. trouble writing, using cellphone credit card machines. unable to carry a cup of coffee to table. went to DR on 2/26/2021. Blood pressure high (not usual). Bloodwork done-all negative for any issues. Blood pressure recheck on 3/12/2021 - still high. Now taking Atenolol for it. I have an appointment to see a neurologist in May. The tremors have decreased little by little. April 12 was a good day (first time since getting these problems) and now , this week have felt much better. 9(((
71 2021-04-18 stroke stroke sx on 4-9-21, final dx cerebral infraction
71 2021-04-18 chest discomfort Within 2 min, Pt asked if it was normal to feel vaccine traveling down arm, "tingling feeling Rt arm... Read more
Within 2 min, Pt asked if it was normal to feel vaccine traveling down arm, "tingling feeling Rt arm down to fingers." She then states top of her head started hurting and denies having symptoms prior to vaccine, and having dizziness, blinking her eyes frequently, newly noted. 1435hrs: BP 195/92, HR69, SpO2 100 on room air, RR 17. BP continued to elevated (197/111, 211/106, 242/113) and transported to exam room and consulted provider who recommended ER. As BP continues to elevate, H/A increases from 2/10 to 5/10, dizziness continues and blurry vision starts. 1503hrs: BP 148/96, HR 46, SpO2 99% on 2L O2 via nasal cannula. Pt states "I'm having medication taste in my mouth, is this normal?" She then states she is having chest pressure and EMS arrives. 1509hrs: Patient transported by EMS to local hospital ER via ambulance and she states after transfer to gurney that "my chest really doesn't feel good."
71 2021-04-18 transient ischaemic attack TIA (diagnosed by neurology), hypertensive crisis, Acute hypokalemia. Hypertensive crisis/spikes wer... Read more
TIA (diagnosed by neurology), hypertensive crisis, Acute hypokalemia. Hypertensive crisis/spikes were treated with anti-hypertensives and patient monitored for 6 days. No TPA used as CVA not diagnosed and symptoms were transient - less than 24 hours. Patient does report some residual visual changes
71 2021-04-19 hypertension EMS was called, because patient began to feel dizzy and extremely nauseous within about 1 minute of ... Read more
EMS was called, because patient began to feel dizzy and extremely nauseous within about 1 minute of being vaccinated. She stood up to walk, but did not get more than 10 feet away before returning to sit down. Her face became flushed. Her BP was high at 177/87 with a pulse of 108, and she complained of having blurry vision. Her blood pressure lowered to 132/90 with a pulse of 82. Her final readings were BP 139/75 and pulse 77 when EMS took them. EMS was called at 1:22pm and arrived at 1:32pm. Pt was given some water and advised to get some rest at home. She refused to ride to the hospital with EMS, and claimed to feel better after another 10-15 minutes or so. EMS thought it was just an anxiety attack.
71 2021-04-19 hypertension Pt received vaccine, after 30 minute wait period left the facility feeling fine. Later that day nose... Read more
Pt received vaccine, after 30 minute wait period left the facility feeling fine. Later that day nose and throat started feeling strange. looked in mirror and saw swelling under bottom lip. Went to see PCP who gave her injection Benadryl and steroid Advised to continue with Benadryl for several days. While at PCP blood pressure was noted to be high. Placed on hypertension medications., pt reacted to BP meds and was then placed on anxiety meds. To see allergist on May 11,2021. States feeling much better now.
71 2021-04-19 fainting patient fainted after injection while trying to stand up. blood pressure ok, pulse ok, breathing o... Read more
patient fainted after injection while trying to stand up. blood pressure ok, pulse ok, breathing ok. All vitals monitored by emt on site. revived after about 10 minutes. Refused to be taken by ambulance. Emt indicated just a sign of anxiety and not from vaccine
71 2021-04-20 anaemia Sore arm, fever, chills, pain in back and hips, severe stomach ache, extreme confusion, anemia
71 2021-04-20 blood pressure increased, heart rate increased a fib was worse (more erratic heartbeat); eyelid and under the eye looked bruised like a shiner; red... Read more
a fib was worse (more erratic heartbeat); eyelid and under the eye looked bruised like a shiner; red markings along side the folds of the nose; face is still red and swollen; slightly elevated blood pressure; lips were swollen; rash running along same side of body as injection; soreness at injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (a fib was worse (more erratic heartbeat)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026120A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stroke in February 2000. Concurrent medical conditions included Allergy and Chronic atrial fibrillation. Concomitant products included APIXABAN (ELIQUIS) and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced RASH (rash running along same side of body as injection), VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 10-Mar-2021, the patient experienced HEART RATE INCREASED (a fib was worse (more erratic heartbeat)) (seriousness criterion medically significant), PERIORBITAL HAEMORRHAGE (eyelid and under the eye looked bruised like a shiner), ERYTHEMA (red markings along side the folds of the nose), SWELLING FACE (face is still red and swollen), BLOOD PRESSURE INCREASED (slightly elevated blood pressure) and LIP SWELLING (lips were swollen). On 06-Mar-2021, RASH (rash running along same side of body as injection) and VACCINATION SITE ERYTHEMA (redness at the injection site) had resolved. On 17-Mar-2021, PERIORBITAL HAEMORRHAGE (eyelid and under the eye looked bruised like a shiner), ERYTHEMA (red markings along side the folds of the nose) and LIP SWELLING (lips were swollen) had resolved. At the time of the report, HEART RATE INCREASED (a fib was worse (more erratic heartbeat)) and BLOOD PRESSURE INCREASED (slightly elevated blood pressure) outcome was unknown, SWELLING FACE (face is still red and swollen) had not resolved and VACCINATION SITE PAIN (soreness at injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment Hydrocortisone cream to face. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
71 2021-04-20 skin turning blue PMR; cyanosis of palm of hand; severe pain in shoulders and hips; bad headache; fever; myalgia; extr... Read more
PMR; cyanosis of palm of hand; severe pain in shoulders and hips; bad headache; fever; myalgia; extreme discomfort; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POLYMYALGIA RHEUMATICA (PMR) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (myalgia), DISCOMFORT (extreme discomfort), HEADACHE (bad headache) and PYREXIA (fever). On 22-Mar-2021, the patient experienced CYANOSIS (cyanosis of palm of hand) and ARTHRALGIA (severe pain in shoulders and hips). On 29-Mar-2021, the patient experienced POLYMYALGIA RHEUMATICA (PMR) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (PMR), MYALGIA (myalgia), DISCOMFORT (extreme discomfort), CYANOSIS (cyanosis of palm of hand), ARTHRALGIA (severe pain in shoulders and hips), HEADACHE (bad headache) and PYREXIA (fever) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant information not provided Additional and treatment information:On 22MAR2021 cyanosis of palm of hand and severe pain in shoulders and hips which has decrease her ability to perform some of her daily living activities because of the pain. On 29MAR2021 she went to urgent care and was verbally diagnosed with PMR. She stated that the HCP told her it was PMR from the 2nd dose of vaccine but the paperwork stated it was musculoskeletal pain. She was started on a Medrol dosepak and referred to her general practitioner. She saw her GP on 6PAR2021 that confirmed the diagnosis of PMR and prescribed her prednisone. On 13APR2021 she was told to half her prednisone dose and almost all the symptoms are returning. She has a fear of no remission. This case was linked to MOD-2021-076703 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
71 2021-04-20 hypertension Anaphylactic reaction; Blood pressure high; Could not breathe; Pain in his arm; This spontaneous cas... Read more
Anaphylactic reaction; Blood pressure high; Could not breathe; Pain in his arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction), HYPERTENSION (Blood pressure high) and DYSPNOEA (Could not breathe) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0031b21a) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COPD. Concurrent medical conditions included Allergy (receives four shots a week for his allergies). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm). On 05-Apr-2021, the patient experienced DYSPNOEA (Could not breathe) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion hospitalization) and HYPERTENSION (Blood pressure high) (seriousness criterion hospitalization). The patient was hospitalized on 06-Apr-2021 due to ANAPHYLACTIC REACTION, DYSPNOEA and HYPERTENSION. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), HYPERTENSION (Blood pressure high), DYSPNOEA (Could not breathe) and PAIN IN EXTREMITY (Pain in his arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment of the events included steroids and blood pressure medication. Additional information:Patient stated he had some pain in his arm. Patient states on 4-5-2021 he could not breathe. Patient states on 4-6-2021 he went to emergency room. Patient stated he was in the intensive care unit for 3 days. Patient stated he was given steroids and blood pressure medicine because his blood pressure was high. Patient stated he was told he had an anaphylactic reaction. Patient stated that the doctor thought it was something he ate. Patient state he has a history of COPD and allergies and receives four shots a week for his allergies. Patient stated he will get itching around his mouth from eating chicken but doesn't believe his symptoms was from food. Company comment:Based on the current information available and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current information available and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
71 2021-04-20 ischaemic stroke If not 100 % sure but she may had an ischemic stroke,This is not normal; viral meningitis; chills; v... Read more
If not 100 % sure but she may had an ischemic stroke,This is not normal; viral meningitis; chills; vision problems,vision problem was bad; hearing problems; This spontaneous case was reported by a consumer and describes the occurrence of ISCHAEMIC STROKE (If not 100 % sure but she may had an ischemic stroke,This is not normal) and MENINGITIS VIRAL (viral meningitis) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. QQ2A21 and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history.). On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced VISION BLURRED (vision problems,vision problem was bad) and HEARING DISABILITY (hearing problems). On an unknown date, the patient experienced ISCHAEMIC STROKE (If not 100 % sure but she may had an ischemic stroke,This is not normal) (seriousness criterion medically significant), MENINGITIS VIRAL (viral meningitis) (seriousness criterion medically significant) and CHILLS (chills). At the time of the report, ISCHAEMIC STROKE (If not 100 % sure but she may had an ischemic stroke,This is not normal), MENINGITIS VIRAL (viral meningitis), VISION BLURRED (vision problems,vision problem was bad), HEARING DISABILITY (hearing problems) and CHILLS (chills) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. Treatment medication includes: Blood thinner Rosuvastatin, 81mg aspirin. Additional information:After second dose had chills but she hear from people who had fever, chills and etc. Woke up on Monday March 8 with vision problems, hearing problems. She waited 8 days until she went to the doctor because everybody says had a reaction but this was getting worse. Went to eye doctor because of vision problem was bad, on March 18 4 weeks after first symptoms appears, optometrist send to her internist and after consultation, on March 23 had 2 MRI head and brain. March 26 had contrast MRI brain, send her for a carotid study in her neck. Went to the internist again, April 2 send to spinal test. April 5 echocardiogram, yesterday went to first appointment with her vision therapeutics. This morning went to the neurologist send her for 2 more brain MRI. If not 100 % sure but she may had an ischemic stroke, doctor will confirm it with the studies. Neurologist confirm she has viral meningitis and the symptoms are similar with ischemic stroke, but that is not confirmed yet. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information is requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information is requested.
71 2021-04-20 loss of consciousness break her ankle; nausea; shaking chills; she fell and passed out; severe dizziness; did not feel her... Read more
break her ankle; nausea; shaking chills; she fell and passed out; severe dizziness; did not feel her self as well for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she fell and passed out) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history.). On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (she fell and passed out) (seriousness criterion medically significant), DIZZINESS (severe dizziness), MALAISE (did not feel her self as well for a couple of days), NAUSEA (nausea) and CHILLS (shaking chills). On an unknown date, the patient experienced ANKLE FRACTURE (break her ankle). On 04-Feb-2021, LOSS OF CONSCIOUSNESS (she fell and passed out) had resolved, DIZZINESS (severe dizziness) and NAUSEA (nausea) outcome was unknown. At the time of the report, MALAISE (did not feel her self as well for a couple of days), ANKLE FRACTURE (break her ankle) and CHILLS (shaking chills) outcome was unknown. Not Provided No treatment information was provided. No relevant concomitant medications was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
71 2021-04-21 anaemia, low platelet count Pt reports she was in Hospital until 2 days ago when she received 2nd Moderna COVID vaccine. She sta... Read more
Pt reports she was in Hospital until 2 days ago when she received 2nd Moderna COVID vaccine. She states that several hours later she began feeling globally weak and with coordination difficulties intermittently (gives example that she would be feeding self, then have difficulty getting utensil to mouth and noted sudden collapse of LE when standing, "they just gave out" and feels that difficulty coordinating her legs led to inability to stand- adamant that it is coordination rather than fatigue or weakness at issue). She feels symptoms in extremities are bilateral and symmetric. Denies prodrome prior to falls, denies LOC but states she fell onto her face and did not "catch" herself "it happened too fast". She has been able to ambulate with assistance to bathroom and in her house in recent days. Denies paresthesias, numbness to groin or perineum. She has been constipated, which is new for her with last BM 4/17 no GIB. Pt denies dysuria or difficulties with urination, though she tells me she has not voided since yesterday. She states she has been eating without n/v or early satiety. No change in chronic cough or DOE. She has not had fevers or chills, denies myalgias or arthralgias.
71 2021-04-22 atrial fibrillation, blood clot, troponin increased Pt presented to the ED from home for b/l lower extremity swelling x 2 weeks. She was reportedly in h... Read more
Pt presented to the ED from home for b/l lower extremity swelling x 2 weeks. She was reportedly in her recliner for approximately 12-18 hrs prior to being brought in via EMS. In the ED her b/l LE extremity was cold to touch and mottled. Her toes were white and nail beds blue. No pulses were found on Doppler on either extremity. She was also noted to be in a.fib with RVR. Doppler of LE showed extensive occlusive thrombus. Bedside echo showed the RV severely dilated with mobile thrombus and EF 20-25%. Given these findings there is a very high probability of massive PE, however given current situation of AKI and instability CT was unable to be performed. She was given TPA and admitted to ICU. Pt was started heparin gtt, as well as levophed and dobutamine for obstructive and cardiogenic shock as her troponin, kidney function, lactate and liver function all were elevated. Of note pt lives in a hoarding situation and lives a sedentary lifestyle and reportedly only gets up from recliner to use the bathroom. Pt also has a 96 pack year history but was noted in her medical chart to have quit smoking in 2017.
71 2021-04-22 lightheadedness, atrial fibrillation, palpitations a few episodes of a-fib; felt like she might black out; felt like her heart was palpitating; stress;... Read more
a few episodes of a-fib; felt like she might black out; felt like her heart was palpitating; stress; headache; could not sleep; burning in her arm, up through her neck and to her chest.; worry; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (a few episodes of a-fib) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart valve replacement (two artificial heart valves.) since 2004. Concomitant products included WARFARIN SODIUM (COUMADIN) for Heart valve replacement. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (burning in her arm, up through her neck and to her chest.). On 18-Apr-2021, the patient experienced SLEEP DISORDER (could not sleep). On an unknown date, the patient experienced ATRIAL FIBRILLATION (a few episodes of a-fib) (seriousness criterion medically significant), PRESYNCOPE (felt like she might black out), PALPITATIONS (felt like her heart was palpitating), ANXIETY (worry), STRESS (stress) and HEADACHE (headache). On 23-Mar-2021, VACCINATION SITE PAIN (burning in her arm, up through her neck and to her chest.) outcome was unknown. At the time of the report, ATRIAL FIBRILLATION (a few episodes of a-fib), PRESYNCOPE (felt like she might black out), PALPITATIONS (felt like her heart was palpitating), SLEEP DISORDER (could not sleep), ANXIETY (worry), STRESS (stress) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the events included Acetaminophen. Echogram scheduled on 05 May 21. Company comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
71 2021-04-26 palpitations Had chills, muscle aches and fatigue six hours after shot administered on the 14th. Then was confir... Read more
Had chills, muscle aches and fatigue six hours after shot administered on the 14th. Then was confirmed by CT scan diverticulitis on the 19th. Prescribed Cipro/Flagyl for meds. Two and a half days in, fatigue, body sweats, overwhelming radiating heat over entire body and racing heart. Went back to ER on 22nd. Did enzyme test to rule out heart attack, switched med regimen to Amoxicillin/Bactrim and took that until 7 days post meds. No pain from diverticulitis but same symptoms of fatigue, body sweats, overwhelming radiating heat over entire body and racing heart persisted.
71 2021-04-26 low platelet count, platelet count decreased Resident was fatigued and more disoriented - beyond baseline confusion. Right knee swelling and pain... Read more
Resident was fatigued and more disoriented - beyond baseline confusion. Right knee swelling and pain present without any fall or injury sustained as resident is non-ambulatory. Resident's lab results 01/26/21 showed PLT result of 118 - Hematology consult was completed, as MD was concerned about sudden onset Thrombocytopenia. Hematology consult was completed 2/8/21 - more lab tests were ordered to rule out further blood disorders (CBC with diff, automated reticulocyte count, total LDH, Hepatic Function panel, Free T4, TSH, Vitamin B12, Haptoglobin, Folate, Free Light Chains, Protein ELP. Results came back on 02/11/21 with PLT level returned to normal (PLT 151) and no further indication that there was a separate blood disorder present. Symptoms resolved and no further follow up required by Hematology or primary MD.
71 2021-04-28 loss of consciousness Vomiting, unconsciencious, convulsions. Transported by ambulance to Hospital. Hospitalized for 5 da... Read more
Vomiting, unconsciencious, convulsions. Transported by ambulance to Hospital. Hospitalized for 5 days. CAT scan, EEG,
71 2021-04-29 blood pressure increased Client felt dizzy after 1st Moderna Covid vaccine. Was taken to EMS area for observation. Hx of ... Read more
Client felt dizzy after 1st Moderna Covid vaccine. Was taken to EMS area for observation. Hx of Hypertension with BP med change 2 weeks ago by private MD. Pt did not eat breakfast. Ice pack placed behind neck for comfort. Wedge support provided for leg support. Water provided. BP ranged from 191-212/91-106. Glucose was 98. O2 sat 95-96. Dizziness waxed and waned but when present was much improved from onset. called for ambulance transport hospital evaluation of persistently elevated BP. IV hep lock inserted by prior to transport to hospital. 12:10: Client was transported.
71 2021-04-30 atrial fibrillation atrial fibrillation
71 2021-04-30 chest pain severe pain in upper chest, neck constricting thrqat closing up, severe headache Lasted 10 to 15 mi... Read more
severe pain in upper chest, neck constricting thrqat closing up, severe headache Lasted 10 to 15 minutes
71 2021-04-30 palpitations, palpitations Vaccine may have caused flare in Graves Disease symptoms. 4 days after the vaccination, I started h... Read more
Vaccine may have caused flare in Graves Disease symptoms. 4 days after the vaccination, I started having heart palpitations. 6 days after the vaccination, I started having double vision in the morning. I have never had heart palpitations from Graves before, although it is a common problem with it I have not had double vision since my eye surgery 5 years ago. Am wondering whether to proceed with second dose of the Moderna vaccine.
71 2021-05-03 blood pressure fluctuation Patient had headache, balance issues, and erratic blood pressure
71 2021-05-03 blood pressure increased SPIKE IN BLOOD PRESSURE ONE WEEK LATER, SEVERE VERTIGO FOR 8 DAYS. VOMITING, EXTREME DIZZYNESS. UNA... Read more
SPIKE IN BLOOD PRESSURE ONE WEEK LATER, SEVERE VERTIGO FOR 8 DAYS. VOMITING, EXTREME DIZZYNESS. UNABLE TO WALK WITHOUT HELP
71 2021-05-04 blood pressure increased, cardiac arrhythmia 1. large red rash on upper right arm. 2. blood pressure started to rise. 3. Bell's Palsey sympto... Read more
1. large red rash on upper right arm. 2. blood pressure started to rise. 3. Bell's Palsey symptoms started to occur. 4. PVC's detected in heart beat. 5. Feelings of uneasiness and anxiety. Blood pressure kept increasing.
71 2021-05-04 loss of consciousness Immediately upon waking up the next morning and fixing coffee, I felt like something was wrong and f... Read more
Immediately upon waking up the next morning and fixing coffee, I felt like something was wrong and felt very weird and couldn't complete making coffee, felt so weak and unsteady, and put my head down to get the blood flowing to my head. That is the last thing I remembered as I fainted, but regained consciousness about 20-30 seconds later. My husband heard me fall and found me flat on my back in front of the coffeemaker. I had to be in bed the entire day, sleeping and resting. I had a nasty bump on the head and cuts and bruises on knees and arms. The next day still feeling weak but am able to function. Lots of aches but don't know if that is from the fall.
71 2021-05-04 heart attack Double pneumonia; Heart attack; was hospitalized was not able to get second dose; This spontaneous c... Read more
Double pneumonia; Heart attack; was hospitalized was not able to get second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Double pneumonia) and MYOCARDIAL INFARCTION (Heart attack) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced OFF LABEL USE (was hospitalized was not able to get second dose). On an unknown date, the patient experienced PNEUMONIA (Double pneumonia) (seriousness criterion hospitalization) and MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). The patient was hospitalized on 31-Mar-2021 due to PNEUMONIA. On 09-Apr-2021, OFF LABEL USE (was hospitalized was not able to get second dose) had resolved. At the time of the report, PNEUMONIA (Double pneumonia) and MYOCARDIAL INFARCTION (Heart attack) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient wanted to know if she should repeat first dose. It was reported that patient was on "a lot" of concomitant medications but did not specify. The patient was in the intensive care unit. No treatment medication was reported. Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
71 2021-05-05 blood pressure increased At approximately 10:10 (approximately 1 hr after receiving vaccine), I developed a huge lump/hive un... Read more
At approximately 10:10 (approximately 1 hr after receiving vaccine), I developed a huge lump/hive under my lower lip; my throat, mouth, and tongue tingled; my blood pressure spiked; and I developed a headache. I called my primary physician and went to his office. He gave me a Benedryl shot and a steroid shot. He ordered blood pressure medicine and Medrol pack. He also suggested I take Benedryl every 6 hours for the next few days. On Sunday, April 25, I woke up and the inside lower part of both of my cheeks were swollen. I went to my dentist on Tuesday, April 27. After a thorough exam, he determined by gums and teeth to be healthy and believed the swelling was related to the swelling under my lip which continues to be there as does the cheek swelling. My blood pressure is normal at this point.
71 2021-05-05 loss of consciousness Passed out in bathroom; Sweating; Fever; Headache; Nausea; Chills; This spontaneous case was reporte... Read more
Passed out in bathroom; Sweating; Fever; Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out in bathroom) in a 71-year-old female patient who received (batch nos. 031B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure. Concomitant products included METFORMIN for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 14-Apr-2021 at 9:30 AM, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021 at 10:30 PM, the patient experienced HYPERHIDROSIS (Sweating), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). On 15-Apr-2021 at 2:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (Passed out in bathroom) (seriousness criteria medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out in bathroom), HYPERHIDROSIS (Sweating), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown. Concomitant medications included blood pressure medications. The patient took Tylenol medication for the treatment. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events 13 hours after the second vaccination, a causal relationship cannot be excluded. Further information has been requested
71 2021-05-05 oxygen saturation decreased, low blood oxigenation Atypical pneumonia; Patient admitted with atypical pneumonia/pneumonitis; Bronchospasm; Initial SaO2... Read more
Atypical pneumonia; Patient admitted with atypical pneumonia/pneumonitis; Bronchospasm; Initial SaO2 values to be in the low to mid 80% range; Cough; Hypoxia; Increasing shortness of breath; This case was received via FDA VAERS (Reference number: 1106702) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of ATYPICAL PNEUMONIA (Atypical pneumonia), PNEUMONITIS (Patient admitted with atypical pneumonia/pneumonitis), BRONCHOSPASM (Bronchospasm), OXYGEN SATURATION DECREASED (Initial SaO2 values to be in the low to mid 80% range), COUGH (Cough), HYPOXIA (Hypoxia) and DYSPNOEA (Increasing shortness of breath) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 immunisation. The patient's past medical history included Obesity, Type II obese diabetic since an unknown date, Arterial hypertension, Dyslipidemia since an unknown date, Anxiety disorder since an unknown date and Endometrial cancer. Concomitant products included CLONAZEPAM, ZOLPIDEM, ESCITALOPRAM and AMLODIPINE BESILATE (NORVASC) for an unknown indication. On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ATYPICAL PNEUMONIA (Atypical pneumonia) (seriousness criterion hospitalization), PNEUMONITIS (Patient admitted with atypical pneumonia/pneumonitis) (seriousness criterion hospitalization), BRONCHOSPASM (Bronchospasm) (seriousness criterion hospitalization), OXYGEN SATURATION DECREASED (Initial SaO2 values to be in the low to mid 80% range) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization), HYPOXIA (Hypoxia) (seriousness criterion hospitalization) and DYSPNOEA (Increasing shortness of breath) (seriousness criterion hospitalization). The patient was hospitalized on 15-Mar-2021 due to ATYPICAL PNEUMONIA, BRONCHOSPASM, COUGH, DYSPNOEA, HYPOXIA, OXYGEN SATURATION DECREASED and PNEUMONITIS. At the time of the report, ATYPICAL PNEUMONIA (Atypical pneumonia), PNEUMONITIS (Patient admitted with atypical pneumonia/pneumonitis), BRONCHOSPASM (Bronchospasm), OXYGEN SATURATION DECREASED (Initial SaO2 values to be in the low to mid 80% range), COUGH (Cough), HYPOXIA (Hypoxia) and DYSPNOEA (Increasing shortness of breath) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Alanine aminotransferase: normal (normal) 53. On 15-Mar-2021, Albumin globulin ratio: normal (normal) 1.1. On 15-Mar-2021, Angiogram: normal (normal) No pulmonary embolus or signs of right heart strain. No thoracic aortic aneurysm or dissection. No enlarged supraclavicular or axillary lymph nodes.. On 15-Mar-2021, Aspartate aminotransferase: normal (normal) 18. On 15-Mar-2021, Blood albumin: normal (normal) 3.9 mg/dl. On 15-Mar-2021, Blood alkaline phosphatase: normal (normal) 74. On 15-Mar-2021, Blood bilirubin: normal (normal) 0.8 mg/dl. On 15-Mar-2021, Blood calcium: normal (normal) 9.1 mg/dl. On 15-Mar-2021, Blood chloride: normal (normal) 105 mEq/L. On 15-Mar-2021, Blood creatinine: 0.7 (normal) normal. On 15-Mar-2021, Blood glucose: 146 (High) high. On 15-Mar-2021, Blood potassium: normal (normal) 3.5 mEq/L. On 15-Mar-2021, Blood sodium: normal (normal) 138 mEq/L. On 15-Mar-2021, Blood urea: 11 mg/dl (normal) normal. On 15-Mar-2021, Brain natriuretic peptide: 17 pg/ml (normal) normal. On 15-Mar-2021, Carbon dioxide: normal (normal) 26 mEq/L. On 15-Mar-2021, Chest X-ray: normal (normal) Scattered areas of subpleural ground-glass opacification. On 15-Mar-2021, Computerised tomogram thorax: normal (normal) FINDINGS: Tracheal air shadow is normal. The aortic arch is not enlarged. Heart size is normal. No definite consolidation or effusion. IMPRESSION: No acute cardiopulmonary process. On 15-Mar-2021, Fibrin D dimer: normal (normal) Quantitative less than 200ng/mL. On 15-Mar-2021, Globulin: normal (normal) 3.7 gm/dL. On 15-Mar-2021, Haematocrit: 44 percent (normal) normal. On 15-Mar-2021, Haemoglobin: 14.1 (normal) 14.1. On 15-Mar-2021, Platelet count: normal (normal) 336 10^3/uL. On 15-Mar-2021, Protein total: normal (normal) 7.6 gm/dL. On 15-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 15-Mar-2021, Troponin I: normal (normal) 6.6. On 15-Mar-2021, White blood cell count: high (High) 15.42 10^3/uL. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information mentioned. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Although a temporal association exists, based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Atypical pneumonia and pneumonitis are assessed as unlikely related. The other events are in consistence with the symptoms of Atypical pneumonia. The patient's comorbidities of diabetes, hypertension, Endometrial cancer and obesity increases the risk of any infection including pneumonia.; Sender's Comments: Although a temporal association exists, based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Atypical pneumonia and pneumonitis are assessed as unlikely related. The other events are in consistence with the symptoms of Atypical pneumonia. The patient's comorbidities of diabetes, hypertension, Endometrial cancer and obesity increases the risk of any infection including pneumonia.
71 2021-05-06 fibrin d dimer increased, chest pain, heart attack, inflammation of the heart muscle Myocarditis Patient presented to the hospital with one episode of troponin positive chest pain. Sh... Read more
Myocarditis Patient presented to the hospital with one episode of troponin positive chest pain. She was diagnosed with an NSTEMI for which she had a coronary angiogram which showed no significant coronary artery disease. She subsequently had CRP (normal)/ESR (mildly elevated) and DDIMER. Ddimer was elevated thus a V/Q scan was done which showed no pulmonary embolism. She went on to have a cardiac MRI which showed evidence of myocarditis.
71 2021-05-06 heart rate increased Difficulty breathing, fast heartbeat, weakness, urine production greatly decreased
71 2021-05-09 fainting Syncope and whole body flushing one minute after vaccine was given, lasting a couple of minutes. Pat... Read more
Syncope and whole body flushing one minute after vaccine was given, lasting a couple of minutes. Patient walked upstairs to primary care provider to be monitored for 30 minutes.
71 2021-05-10 nosebleed, blood pressure increased Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup); Blood pressure was ... Read more
Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup); Blood pressure was 175/85; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup)) and BLOOD PRESSURE INCREASED (Blood pressure was 175/85) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 036A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and VITAMINS NOS for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced EPISTAXIS (Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup)) (seriousness criterion medically significant) and BLOOD PRESSURE INCREASED (Blood pressure was 175/85) (seriousness criterion medically significant). At the time of the report, EPISTAXIS (Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup)) and BLOOD PRESSURE INCREASED (Blood pressure was 175/85) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Blood pressure measurement: 175/85 (High) 175/85. On an unknown date, Blood pressure measurement: 144/70 (Inconclusive) 144/70. The reporter had she noticed a large amount of blood (estimates about 1/4 cup) around her computer tray and that her nose was bleeding like a faucet. Her husband took her to the ER, where her blood pressure was 175/85. Caller does not normally have high blood pressure, and is not on blood pressure medication. When she left the ER, her blood pressure was 144/70 and they clamped her nose and gave her some oxymetazoline nose spray for any break-through bleeding. Her husband maintains that the nose bleed was caused by the vaccine. Treatment procedure in the Emergency Room (ER) included nose clamped and medication included oxymetazoline. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
71 2021-05-10 fast heart rate, palpitations Malaise, nausea, palpitations, tacchycardia and shortness of breath with exertion. Symptoms lasted ... Read more
Malaise, nausea, palpitations, tacchycardia and shortness of breath with exertion. Symptoms lasted 2 weeks. Patient did not seek medical advice
71 2021-05-12 loss of consciousness She got her vaccine, had no problems. Went home felt tired and ate some oatmeal but only about 1/3 ... Read more
She got her vaccine, had no problems. Went home felt tired and ate some oatmeal but only about 1/3 of what she normally eats. She went to bed and woke up and told her husband that she had flu like feeling. She got up to move and continued to have light headed spells and felt if she held her head back she would pass out. She then walked into the kitchen as she was thirsty and her stomach unsettled, went to the fridge and then does not remember anything other than her son being at the house. Her husband called him, and it was 15 minutes while she was out before she regained consciousness. They told her they called 9-1-1 and went to the bathroom and the paramedics checked her out and recommended for her to go to the hospital. She was transported to the ER, and based on the info they had they checked her for a stroke. They sent her for a brain scan. The Dr. told her that she had a healthy brain. They monitored her and was in the ER until that evening, she was then transferred to a room and put on a motion and heart monitor to keep check on her. She did not have anymore episodes of syncope and checked her out and told her that everything was WNL. They were trying to find out what caused her blackout spell. She asked if she could take the 2nd vaccine, and he told her that she needed it. She came home on Monday evening after being discharged. She had no energy until the last week or so since that episode. She still has a brain fog, trouble just thinking and makes quilts for hospice patients and was able to complete that task last week. Her brain fog is better and her fatigue is improving.
71 2021-05-12 loss of consciousness She got her vaccine, felt fine, the shot didn't hurt until probably about 6 hours later she began to... Read more
She got her vaccine, felt fine, the shot didn't hurt until probably about 6 hours later she began to feel not sick, but not totally well, feeling blah. Through the night, she did not sleep well, probably awake as much as sleeping. In the middle of the night her husband was up and she said she felt as if she had the virus, as well as her husband. She ate about 1/3 of a bowl of oatmeal, and it did not make her feel better. She did not have any energy and hurt as if she had had a bad fall. She had periods of her head floating away, strange feeling. She got up to move and continued to have light headed spells and felt if she held her head back she would pass out. She then walked into the kitchen as she was thirsty and her stomach unsettled, went to the fridge and then does not remember anything other than her son being at the house. Her husband called him, and it was 15 minutes while she was out before she regained consciousness. They told her they called 9-1-1 and went to the bathroom and the paramedics checked her out and recommended for her to go to the hospital. She was transported to the ER, and based on the info they had they checked her for a stroke. They sent her for a brain scan. The Dr. told her that she had a healthy brain. They monitored her and was in the ER until that evening, she was then transferred to a room and put on a motion and heart monitor to keep check on her. She did not have anymore episodes of syncope and checked her out and told her that everything was WNL. They were trying to find out what caused her blackout spell. She asked if she could take the 2nd vaccine, and he told her that she needed it. She came home on Monday evening after being discharged. She had no energy until the last week or so since that episode. She still has a brain fog, trouble just thinking and makes quilts for hospice patients and was able to complete that task last week. Her brain fog is better and her fatigue is improving.
71 2021-05-13 atrial fibrillation The patient developed atrial fibrillation the day after the first vaccination. She also developed it... Read more
The patient developed atrial fibrillation the day after the first vaccination. She also developed it the day after the second vaccination (Lot #022C1A, May 12, 2021) Moderna for both. The atrial fibrillation which began after the second dose required hospitalization. The patient has a history of atrial fibrillation
71 2021-05-16 palpitations, hypotension, heart rate increased 1. 05/14/21: Physiological shock, about 30 minutes, immediately after injection - 2nd vacc. 2. 05/15... Read more
1. 05/14/21: Physiological shock, about 30 minutes, immediately after injection - 2nd vacc. 2. 05/15/21: Unusual fatigue similar to the flu, entire day. Pain at injection site. (05/16/21, no symptoms) 3. 05/17/21: Low blood pressure, about 8 hours. BP, 70/45 to 85/50. Rapid pulse, 90-99. Felt heart pounding in chest, weakness, fatigue, and dizziness so used home blood pressure measuring device to determine rate multiple times.. But no shortness of breath. Note, felt shock shortly after the vaccination. Although I waited the required 15 minutes at the cliniic, because I was in shock and alone, was unable to report it to anyone. Would have been good if a clinician had checked up on me. Had a ride to take me home.
71 2021-05-16 pulmonary embolism, chest pain Difficulty breathing, chest pain, dyspnea on minimal exertion. Diagnosed with diffuse pulmonary emb... Read more
Difficulty breathing, chest pain, dyspnea on minimal exertion. Diagnosed with diffuse pulmonary emboli involving the distal main branches as well as the proximal segmental and diffusely throughout the subsegmental branches of both lungs. Elevated right ventricular over left ventricular ratio greater than 1.0 suggesting right-sided heart strain and increased right-sided heart pressures. Admitted and treated with IV heparin bolus and infusion.
71 2021-05-18 pulmonary embolism, deep vein blood clot Patient presented to the ED and was subsequently hospitalized for DVT on 4/7/21. She also presented ... Read more
Patient presented to the ED and was subsequently hospitalized for DVT on 4/7/21. She also presented to the ED and was subsequently hospitalized for pulmonary embolism on 5/7/21. These visits are within 6 weeks of receiving COVID vaccination.
71 2021-05-18 fainting Lightheadedness, dizziness and fainting
71 2021-05-18 troponin increased Headache, vomiting so severe it was associated with a troponin elevation despite coronary arteries h... Read more
Headache, vomiting so severe it was associated with a troponin elevation despite coronary arteries having no significant coronary artery disease on cardiac catheterization.
71 2021-05-22 heart rate irregular, heart rate increased, cardiac arrhythmia I had shaking, nausea, weak muscles, chills, and rapid irregular heartbeats. The irregular heartbe... Read more
I had shaking, nausea, weak muscles, chills, and rapid irregular heartbeats. The irregular heartbeats continued for 3 months and just now finally went away. The weak muscles lasted 3 weeks.
71 2021-05-23 blood pressure increased, cerebrovascular accident 71 yo R handed female PMHx of obesity, anxiety, depression, HTN, afib, and COVID infection who prese... Read more
71 yo R handed female PMHx of obesity, anxiety, depression, HTN, afib, and COVID infection who presented to ED on 5/15/2021 with stroke like symptoms. She presented with right sided weakness, facial droop and slurred speech. LKWT 5/15/2021 at 0430. Patient reported going to bed around 2300 the night before and woke up at 0400 that morning with right sided weakness. Her daughter noticed slurred speech and right sided facial droop. Denied chest pain, HA, dizziness, no vision changes and no history of CVA. Stroke protocol was called. Teleneuro consulted and recommended a MRI. CT head was unremarkable. She takes ASA at home and received Plavix per neuro recommendations. Of note, patient tested positive for COVID but denied any respiratory symptoms and she has received her first COVID vaccination. Patient was admitted to the hospital for further treatment and evaluation for suspected CVA. Neurology consulted. Continued ASA, Plavix and Statin. Allowed for permissive HTN. Patient with history of Atrial fibrillation, currently normal sinus rhythm on telemetry. CHADS2VASC 3-would benefit from AC if no contraindication. Unsure why she has not been placed on AC and patient stated he only had one episode of Afib. Chest XR showed No acute cardiac pulmonary findings. Patient refused to have MRI brain due to anxiety. She stated that she attempted to have a MRI before and even with medication for anxiety she was not able to. Echo showed normal EF, mild MR, AR, TR, no PFO noted.CTA head and neck showed right vertebral artery ends in PICA, no acute abnormalities. Labs noted B12 4,268 cholesterol 231 total, HDL 52, LDL 152, TAG 134, HbA1c 6.2, TSH WNL. Patient was out of the window for tPA. She was given a large dose of IV Ativan for anxiety. She continued to have elevated blood pressures with nausea that required IV labetalol to maintain blood pressure. HTN could likely be due to her significant anxiety. Cardiology planned to follow patient after discharge to discuss AC medication. Patient initially tested positive for COVID on 2/2/2021 and was able to take patient out of isolation. Dx: CVA
71 2021-05-24 blood pressure increased Headache, nausea, dizziness, ( migraine headache), fuzzy thinking and general malaise, B/P 200/110. ... Read more
Headache, nausea, dizziness, ( migraine headache), fuzzy thinking and general malaise, B/P 200/110. Stayed at site until B/P was down to 180 and starting to feel better, 12:30 pm. By evening B/P was down to 142/90, still tired and not feeling well but most of migraine was gone. Today, May 25, still tired and not feeling well, nausea, arm slightly sore, no diarrhea yet at 12:30 p.m.
71 2021-05-25 bleeding on surface of brain subarachnoid hemorrhage - severe headache and pain in neck, let pain
71 2021-05-25 blood clot Embolism arterial; Thrombosis; Herpes zoster; Limb discomfort; Pain in extremity; Feeling hot; This ... Read more
Embolism arterial; Thrombosis; Herpes zoster; Limb discomfort; Pain in extremity; Feeling hot; This case was received via VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EMBOLISM ARTERIAL (Embolism arterial), THROMBOSIS (Thrombosis), HERPES ZOSTER (Herpes zoster), LIMB DISCOMFORT (Limb discomfort), PAIN IN EXTREMITY (Pain in extremity) and FEELING HOT (Feeling hot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. Concurrent medical conditions included COPD and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication. On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 31-Mar-2021, the patient experienced EMBOLISM ARTERIAL (Embolism arterial) (seriousness criteria hospitalization and medically significant), THROMBOSIS (Thrombosis) (seriousness criteria hospitalization and medically significant), HERPES ZOSTER (Herpes zoster) (seriousness criterion hospitalization), LIMB DISCOMFORT (Limb discomfort) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Pain in extremity) (seriousness criterion hospitalization) and FEELING HOT (Feeling hot) (seriousness criterion hospitalization). At the time of the report, EMBOLISM ARTERIAL (Embolism arterial), THROMBOSIS (Thrombosis), HERPES ZOSTER (Herpes zoster), LIMB DISCOMFORT (Limb discomfort), PAIN IN EXTREMITY (Pain in extremity) and FEELING HOT (Feeling hot) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Full blood count: unknown (Inconclusive) Unknown. On 31-Mar-2021, Ultrasound Doppler: unknown (Inconclusive) Unknown. On 31-Mar-2021, Whole body scan: unknown (Inconclusive) Unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient went to hospital because of blood clots and he had an emergency surgery. It was a huge arterial clot and developed shingles. Action taken with mRNA-1273 in response to the events was not applicable. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
71 2021-05-26 cerebrovascular accident, transient ischaemic attack The morning after she got her second vaccination (2/3/2021), she was unresponsive. She was then tak... Read more
The morning after she got her second vaccination (2/3/2021), she was unresponsive. She was then taken to the hospital, by ambulance. They did multiple tests, Blood work, urine sample, CT scans, and had no results. Then they transferred her to get an MRI at hospital, and then went back to original hospital. MRI confirmed she had a stroke and multiple TIAs (mini strokes). Then she was admitted and slept all day on 2/4/2021, finally awoke on 2/5/2021. She stayed in the hospital about a week, and then was transferred to a nursing home/ rehab facility - Facility on 2/10/2021. She was there until March 3rd, 20 days after being admitted. She was then released to go home on 3/3/2021. She has now recovered since then. She is having home health coming to her house, but is no longer going to be there starting June 1st.
71 2021-05-27 hypertension, ischaemic stroke Patient with no previously documented medical history received first dose of vaccine on 5/3/21. On 5... Read more
Patient with no previously documented medical history received first dose of vaccine on 5/3/21. On 5/5, presented to urgent care clinic and was transferred to hospital with confusion, and new facial droop. Diagnosed with acute ischemic stroke, and new diagnosed hypertension and diabetes mellitus. Unknown if vaccine was the only known cause of her hospitalization, and health outcomes.
71 2021-05-27 hypertension I had very high blood pressure over 185/120 not my normal blood pressure.
71 2021-05-27 palpitations I had heart palpitations and an allergic reaction when I received the shot - so I stayed in the buil... Read more
I had heart palpitations and an allergic reaction when I received the shot - so I stayed in the building for 30 minutes. Then my arm started hurting immediately. That afternoon I couldn't lift my arm. The site where I received the injection became redder. There was a lot of swelling in that area. I was nauseous and fatigued for three weeks. And rectal bleeding occurred the night I received the vaccine.
71 2021-05-31 hypertension, heart rate increased I begin feeling lightheaded, my face started feeling flushed, my body was tingling, EMT took my bloo... Read more
I begin feeling lightheaded, my face started feeling flushed, my body was tingling, EMT took my blood pressure and it was high with a high heart rate, headache. Kept having chronic daily headache since the vaccination. Now I'm on medication for the headaches. Having imbalance like I can't walk or feel like I'm going to fall over.
71 2021-06-01 deep vein blood clot bilateral pneumonia; acute on chronic respiratory failure; left lower extremity deep vein thrombosis... Read more
bilateral pneumonia; acute on chronic respiratory failure; left lower extremity deep vein thrombosis; This spontaneous case was reported by a physician and describes the occurrence of ACUTE RESPIRATORY FAILURE (acute on chronic respiratory failure), PNEUMONIA (bilateral pneumonia) and DEEP VEIN THROMBOSIS (left lower extremity deep vein thrombosis) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012LZ0A and 029L20A) for COVID-19 vaccination. Concurrent medical conditions included Food allergy (corn, dairy aid, peanuts,tomato), Drug allergy (codeine, aspirin, chlorine, tartrazine, lanolin, Prevnar, Pulmicort, penicillin.), Iodine contrast media allergy, Allergy (cat dander, yellow dye, purple dye), Latex allergy, Hypertension, COPD and Lung cancer. Concomitant products included ALPRAZOLAM, BENZONATATE, ENOXAPARIN, GABAPENTIN, HCTZ, HYDROCODONE, ACETAMINOPHEN, OMEPRAZOLE, PREDNISONE, PROCHLORPERAZINE EDISYLATE (COMPAZINE [PROCHLORPERAZINE EDISYLATE]), BECLOMETASONE DIPROPIONATE (QVAR), MONTELUKAST and CETIRIZINE for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (left lower extremity deep vein thrombosis) (seriousness criterion medically significant). On 05-May-2021, the patient experienced ACUTE RESPIRATORY FAILURE (acute on chronic respiratory failure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PNEUMONIA (bilateral pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 05-May-2021 due to ACUTE RESPIRATORY FAILURE and PNEUMONIA. The patient was treated with Hospice care (increased supplemental oxygen) for Pneumonia. At the time of the report, ACUTE RESPIRATORY FAILURE (acute on chronic respiratory failure), PNEUMONIA (bilateral pneumonia) and DEEP VEIN THROMBOSIS (left lower extremity deep vein thrombosis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Ultrasound Doppler: unknown (Inconclusive) unknown. On 05-May-2021, Chest X-ray: unknown (Inconclusive) unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. treatment includes IV antibiotics. concomitant medication includes duo-nebs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
71 2021-06-03 deep vein blood clot DVT left upper extremity; Left cephalic vein
71 2021-06-03 oxygen saturation decreased I had the vaccine and in 01/31/21 my oxygen level dropped to 75-76 I had difficulty breathing so I w... Read more
I had the vaccine and in 01/31/21 my oxygen level dropped to 75-76 I had difficulty breathing so I went to the hospital, they did a CT Scan and it showed ground glass opacity which is pneumonia in both lungs, they also did a Bronchoscopy, echocardiogram and blood tests. I was admitted on the same day, I was there for 4 days. They gave me anti-inflammatory meds, doxycycline, Lasix.
71 2021-06-06 chest discomfort, heart attack, chest pain Pain radiating from the tips of one hand to the tips of the other along with chest pain like a truck... Read more
Pain radiating from the tips of one hand to the tips of the other along with chest pain like a truck was setting on it!
71 2021-06-06 blood clot The night after receiving the vaccine, the patient began having continuous fevers and coughs. It was... Read more
The night after receiving the vaccine, the patient began having continuous fevers and coughs. It was later discovered that there were blood clots in the lung and legs. Patient health rapidly declined during hospitalization period. Mobility, apetite and overall strength and energy decreased. Patient was fully bedridden and soon lost eye sight.
71 2021-06-09 palpitations, atrial fibrillation There was a little soreness and redness. A couple days after my heart started racing and it got wors... Read more
There was a little soreness and redness. A couple days after my heart started racing and it got worse. I went into Afiv and was hospitalized for 3 days. I had my heart shocked three times to get it into rhythm.
71 2021-06-09 blood clot Blood clots in her leg and lungs; She is black and blue; She felt pain above her knee and on the ins... Read more
Blood clots in her leg and lungs; She is black and blue; She felt pain above her knee and on the inside of her thigh toward the groin that felt like she had been wearing a tight sock. Also felt pain midway between her knee and ankle; She also felt pain midway between her knee and ankle; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clots in her leg and lungs) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Dyslipidaemia. Concurrent medical conditions included Blood pressure high, Depression, Acid reflux (oesophageal) and Allergy. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced GROIN PAIN (She felt pain above her knee and on the inside of her thigh toward the groin that felt like she had been wearing a tight sock. Also felt pain midway between her knee and ankle) and ARTHRALGIA (She also felt pain midway between her knee and ankle). On 18-May-2021, the patient experienced THROMBOSIS (Blood clots in her leg and lungs) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CONTUSION (She is black and blue). The patient was hospitalized from 21-May-2021 to 22-May-2021 due to THROMBOSIS. The patient was treated with APIXABAN (ELIQUIS) on 22-May-2021 at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clots in her leg and lungs), CONTUSION (She is black and blue), GROIN PAIN (She felt pain above her knee and on the inside of her thigh toward the groin that felt like she had been wearing a tight sock. Also felt pain midway between her knee and ankle) and ARTHRALGIA (She also felt pain midway between her knee and ankle) outcome was unknown. The patient thought there were bug bites on her leg on 12-May-2021. Treatment also included IV blood thinner while she was hospitalized. The action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.
71 2021-06-14 heart rate increased Heart rate went up and Bleedind in stool and a fever
71 2021-06-16 deep vein blood clot Patient has been on Revlimid since 2012 with no issues which had the potential to increase coagulopa... Read more
Patient has been on Revlimid since 2012 with no issues which had the potential to increase coagulopathy. Patient has been on appropriate prophylaxis with aspirin daily with no previous clots. Patient got second dose of Moderna COVID vaccine on 3/5/21. Beginning ~2 weeks ago (late May) from current admission (6/10), patient began developing right leg swelling. Patient underwent lower extremity ultrasound at outside hospital on 6/9 and was found to have extensive deep vein thrombosis throughout right leg. Patient started on Eliquis and referred to the hospital. Patient started on argatroban for concerns of post-COVID vaccine coagulopathy.
71 2021-06-17 hypertension Blood pressure was 195/96; Shortness of breath; Confusion; Weakness; Diarrhea; Speech was slurred; A... Read more
Blood pressure was 195/96; Shortness of breath; Confusion; Weakness; Diarrhea; Speech was slurred; Additional rashes appeared; Chills; Tired; Headache; Joint pain; rashes that started to appear, itching, discomfort; Discomfort; Slept most of the night; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Blood pressure was 195/96) and DYSPNOEA (Shortness of breath) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMINS NOS for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SOMNOLENCE (Slept most of the night). On 15-Mar-2021, the patient experienced RASH PRURITIC (rashes that started to appear, itching, discomfort), DISCOMFORT (Discomfort) and ARTHRALGIA (Joint pain). On 16-Mar-2021, the patient experienced HYPERTENSION (Blood pressure was 195/96) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confusion), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), DYSARTHRIA (Speech was slurred), RASH (Additional rashes appeared), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Headache). The patient was hospitalized from 16-Mar-2021 to 17-Mar-2021 due to DYSPNOEA and HYPERTENSION. The patient was treated with FLUTICASONE PROPIONATE (FLONAZE) (intravenous) at an unspecified dose and frequency; FAMOTIDINE at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 13-Mar-2021, SOMNOLENCE (Slept most of the night) had resolved. On 16-Mar-2021, HYPERTENSION (Blood pressure was 195/96), CONFUSIONAL STATE (Confusion) and DYSARTHRIA (Speech was slurred) had resolved. On 17-Mar-2021, RASH PRURITIC (rashes that started to appear, itching, discomfort), DIARRHOEA (Diarrhea) and RASH (Additional rashes appeared) had resolved. At the time of the report, DYSPNOEA (Shortness of breath) had not resolved and DISCOMFORT (Discomfort), ASTHENIA (Weakness), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 195/96 (High) units not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
71 2021-06-17 fainting pt had a syncopal episode the morning following her vaccination, n o further episodes. she is just ... Read more
pt had a syncopal episode the morning following her vaccination, n o further episodes. she is just now reporting it. work up in progress including labs, MRI, ultrasound
71 2021-06-18 hypertension Within an hour, patient developed injection site reaction with redness, swelling and pain. She also ... Read more
Within an hour, patient developed injection site reaction with redness, swelling and pain. She also reported to the local emergency room with an episode of hypertension and extreme nausea. Hypertension and nausea subsided within 24 hours, but injection site is still inflamed and painful 2 days after immunization
71 2021-06-20 stroke, low blood oxigenation, troponin increased 71-year-old female with history of chronic obstructive pulmonary disease, CVA, type 2 diabetes hyper... Read more
71-year-old female with history of chronic obstructive pulmonary disease, CVA, type 2 diabetes hypertension who presented with hypoxia and altered mental status. At baseline she is alert and oriented to self, she has a guardian. It appears she was noted to be more somnolent than usual at her facility and found to be hypoxemic so was sent to ER for further evaluation. She required 4L oxygen via nasal cannula to maintain saturation. On arrival to ER, her labs were notable for mild AKI, troponin elevation, leukocytosis and positive COVID19 PCR. Chest xray was consistent with patchy bilateral lower lobe airspace disease. CT Head showed a chronic large right MCA infarct without acute hemorrhagic changes
71 2021-06-20 chest discomfort, chest pain 20 min. after delivery of 1st Moderna vac. I experienced chest pressure and pain lasting 30-45 sec. ... Read more
20 min. after delivery of 1st Moderna vac. I experienced chest pressure and pain lasting 30-45 sec. For 5 days after that 1st event I experienced increased chest pain and pressure upon exersion. The pain/pressure eventually felt in throat, jaw and head area. After 5 days my Dr. sent me to ER where I had numerous tests. It was determined that I had a left artery that was 99% occluded. I had 2 stents placed. and was hospitalized for 4 days. Prior to the vac., I was symptom free.
71 2021-06-20 chest pain approx 48hr post injection I experienced severe pain at site of injection radiating to my chest/rib ... Read more
approx 48hr post injection I experienced severe pain at site of injection radiating to my chest/rib area and could not get out of bed. I saw my doctor and discussed SIRVA(injury related to vaccine administration)and she stated" probably made up by ambulance chaser." I was referred to physical therapy. I read up on VAERS and spoke with the Infectious disease doctor for the County and she stated that my complaints are valid and that is why I am filing VAERS report so late. She stated I should have received steroid treatment. I reported to my doctor that the injection had been given ^high in arm @acromion process, not in deltoid area as it should have been
71 2021-06-20 heart attack Acute respiratory failure, MI; RSV
71 2021-06-23 chest discomfort, chest pain Lots of headaches. On June 9, 2021, Vision in left eye became fragmented and jumbled and stationary ... Read more
Lots of headaches. On June 9, 2021, Vision in left eye became fragmented and jumbled and stationary objects appeared to move. Didn?t clear up for 72+ hours. Couple days later felt like I was having a heart attack, pain and tightness in chest, tightness in jaws, short of breath
71 2021-06-23 palpitations, heart rate increased Started to noticed heart pounding in the night and it was rapid, and it was hard for me to sleep. I ... Read more
Started to noticed heart pounding in the night and it was rapid, and it was hard for me to sleep. I kept checking my heart rate and it was much higher than normal. With very little exertion I felt lightheaded. I never experienced that before. It was scary. It was in the 90's and 100's and normally I'm in the 80's. That happened for three weeks (the pounding) and then it started racing - and I was extra tired. I couldn't do very much. I contacted clinic. They ran some tests and by that time it seemed like things were starting to get better. I feel now like I use to before this.
71 2021-06-24 palpitations, arrhythmia 1st vaccine- same day of vaccine experienced lymph nodes under my left arm pit and arm, had difficul... Read more
1st vaccine- same day of vaccine experienced lymph nodes under my left arm pit and arm, had difficulty breathing and could not take my Advair medication. These symptoms lasted one week to clear up or so. 2nd vaccine- experienced one week after developed heart problems with pain, rapid heart palpitations, extreme fatigue and arrhythmia. I went to the ER for five and a half hours where they performed EKG, lab work, x-rays and I was sent to a cardiologist to monitor my heart symptoms. As a result of my heart symptoms, I now have exacerbation of other conditions to my body, also now have multiple myelomas, bone cancer and breast cancer. I continue with my heart symptoms today and continue to follow up with my cardiologist.
71 2021-06-24 blood vessels inflammation 1. Diagnosed with petechiae 04/01/2021 - no treatment, lesions began to form on lower left and righ... Read more
1. Diagnosed with petechiae 04/01/2021 - no treatment, lesions began to form on lower left and right legs 2. Diagnosed with vasculitis and edema 04/23/2021, treated with antibiotics large lesions mainly on lower left leg, some on lower right, lower legs very swollen, lab results indicated staf infection 3. Diagnosed with high amount of protein in urine and swelling inlayer legs 05/28/2021, treated with furosemide for edema 4. 06/03/2021 - kidney biopsy to check for kidney disease 5. 06/11/2021 - Mild chronic (long term) kidney disease
71 2021-06-25 blood pressure increased Sudden onset severe vestibular neuritis with vertigo, vomiting, extreme prostration - extremely symp... Read more
Sudden onset severe vestibular neuritis with vertigo, vomiting, extreme prostration - extremely symptomatic with significantly elevated BP - severely symptomatic x 36 hrs - mildly symptomatic for another 3 days
71 2021-06-25 heart flutter About 10-15 days after receiving the second dose of the vaccine, I experienced symptoms similar to... Read more
About 10-15 days after receiving the second dose of the vaccine, I experienced symptoms similar to those of a panic attack. light-headedness, a fluttery sensation in the chest (heart area) and temblor in the hands.
71 2021-06-28 chest discomfort hard time breathing, tightness in chest. ears started hurting, nausea , severe abdominal pain, could... Read more
hard time breathing, tightness in chest. ears started hurting, nausea , severe abdominal pain, could not swallow water body aches, chill, body aches, voice was hoarse.
71 2021-06-28 hypertension, ischaemic stroke Confusional state; Diabetes mellitus; Facial paralysis; Hypertension; Ischaemic stroke; This case wa... Read more
Confusional state; Diabetes mellitus; Facial paralysis; Hypertension; Ischaemic stroke; This case was received via VAERS (Reference number: 1358541) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CONFUSIONAL STATE (Confusional state), DIABETES MELLITUS (Diabetes mellitus), FACIAL PARALYSIS (Facial paralysis), HYPERTENSION (Hypertension) and ISCHAEMIC STROKE (Ischaemic stroke) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced CONFUSIONAL STATE (Confusional state) (seriousness criteria hospitalization and disability), DIABETES MELLITUS (Diabetes mellitus) (seriousness criteria hospitalization, disability and medically significant), FACIAL PARALYSIS (Facial paralysis) (seriousness criteria hospitalization, disability and medically significant), HYPERTENSION (Hypertension) (seriousness criteria hospitalization and disability) and ISCHAEMIC STROKE (Ischaemic stroke) (seriousness criteria hospitalization, disability and medically significant). The patient was hospitalized on 05-May-2021 due to CONFUSIONAL STATE, DIABETES MELLITUS, FACIAL PARALYSIS, HYPERTENSION and ISCHAEMIC STROKE. At the time of the report, CONFUSIONAL STATE (Confusional state), DIABETES MELLITUS (Diabetes mellitus), FACIAL PARALYSIS (Facial paralysis), HYPERTENSION (Hypertension) and ISCHAEMIC STROKE (Ischaemic stroke) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Patient received first dose of vaccine on 5/3/21. On 5/5, presented to urgent care clinic and was transferred to hospital with confusion, and facial droop. Patient was Diagnosed with acute ischemic stroke, new diagnosis hypertension and diabetes mellitus. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
71 2021-06-29 blood pressure increased Within 12 mins of receiving the first vaccine I started to swell in the right cheek and right eye an... Read more
Within 12 mins of receiving the first vaccine I started to swell in the right cheek and right eye and my blood pressure was elevated. They did monitor me at the vaccine site and gave me Benadryl and monitored me. Within in an hour my lower jaw started to swell and itch. I was taken to the Hospital, they decided to give me an IV of Benadryl, and steroid. They decided to discharge me when my blood pressure went down. I few days after I started to develop cold sores around my mouth and in my nasal cavity. The doctor decided to prescribe me medicine that treats shingles. I continued to feel tired and not myself.
71 2021-06-29 cerebrovascular accident Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASC... Read more
Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high (had been put on hypertension medication). Concomitant products included LOSARTAN for Hypertension. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized for 2 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. Concomitant medications were not reported. Treatment medications were not provided. This case concerns a 71-year-old female hospitalized with a serious unexpected event of cerebrovascular accident. Event latency 55 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-066369 (Patient Link).; Sender's Comments: This case concerns a 71-year-old female hospitalized with a serious unexpected event of cerebrovascular accident. Event latency 55 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
71 2021-07-05 atrial fibrillation, blood clot showed clot in heart/ I have a blood clot in my heart, and it was after taking the injection; atrial... Read more
showed clot in heart/ I have a blood clot in my heart, and it was after taking the injection; atrial fibrillation persisting; experienced shortness of breath; general weakness; weakness in legs, especially thighs; soreness at the injection site; redness at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation persisting) and THROMBOSIS (showed clot in heart/ I have a blood clot in my heart, and it was after taking the injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Myocardial infarction (5 "MI"s) and Open heart surgery. Concurrent medical conditions included Diabetic retinopathy, Blindness, Atrial fibrillation (started about 2 years ago) and Type 2 diabetes mellitus. Concomitant products included TEMAZEPAM for Insomnia, DULAGLUTIDE (TRULICITY) for Type 2 diabetes mellitus, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (LIPITOR), DILTIAZEM, CARVEDILOL (COREG), SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), LOPERAMIDE HYDROCHLORIDE (IMODIUM), ISOSORBIDE MONONITRATE (ISOSORBIDE MONONITE), EMPAGLIFLOZIN (JARDIANCE), POTASSIUM CHLORIDE (KLOR-CON), FUROSEMIDE (LASIX [FUROSEMIDE]), LEVOTHYROXINE, MAGNESIUM OXIDE, PAROXETINE HCL and PARACETAMOL (TYLENOL) for an unknown indication. On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). In March 2021, the patient experienced DYSPNOEA (experienced shortness of breath), ASTHENIA (general weakness) and MUSCULAR WEAKNESS (weakness in legs, especially thighs). On 07-May-2021, the patient experienced THROMBOSIS (showed clot in heart/ I have a blood clot in my heart, and it was after taking the injection) (seriousness criterion medically significant). In May 2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation persisting) (seriousness criterion medically significant). The patient was treated with WARFARIN SODIUM (JANTOVEN) ongoing from 07-May-2021 at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation persisting), THROMBOSIS (showed clot in heart/ I have a blood clot in my heart, and it was after taking the injection), DYSPNOEA (experienced shortness of breath), ASTHENIA (general weakness), MUSCULAR WEAKNESS (weakness in legs, especially thighs), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Arteriogram: clot in heart (Inconclusive) clot in heart. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient received first dose vaccine on 28Jan2021, and she had no problems. Patient was on pacer and defibrillator. Patient had a nuclear stress test in May2021 which did not show anything. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
71 2021-07-05 blood clot, nosebleed I was asleep and I woke up because I felt something sticky coming out of my nose. It started like wa... Read more
I was asleep and I woke up because I felt something sticky coming out of my nose. It started like water coming out of a faucet however it was blood. I went to the sink and it continued to pour. The next day I went to the ER. It would stop briefly but I could not breathe from the left side of my nose because it felt like a clot was forming. If I would touch it it would feel like the blood clot was forming again. At the ER is when this blood clot came out like pulling on a rubber band. The day after that I went into a specialist for these kinds of things. He said he could see the vessel and he was going to cauterized it.
71 2021-07-06 arrhythmia, heart rate increased, palpitations Heart beat increased to 100+ over a two-day period following the 2nd Covid shot. Fatigue, mild feve... Read more
Heart beat increased to 100+ over a two-day period following the 2nd Covid shot. Fatigue, mild fever also experienced for a day and a half following the day of the vaccination. Then the frequency of my heart arrythmias increased. My pulse readings on my recording blood pressure cuff showed arrythmias every time I took my blood pressure for the entire month of April. I reported this to my primary care doctor on April 30th and she sent me to provider for an EKG, an echocardiogram, and a heart monitor test.
71 2021-07-07 chest pain, palpitations, inflammation of the pericardium I received my vaccine 3/18/2021 around 5/24/2021 I started getting swollen glands, nausea, diarrhea ... Read more
I received my vaccine 3/18/2021 around 5/24/2021 I started getting swollen glands, nausea, diarrhea and headaches. I called my Dr. on 6/2/2021 because I started having symptoms of Pneumonia, it's the first time I had pneumonia and it was very different from anything I had ever had. I did not go into the office and I was prescribed Azithromycin and Prednisone. The next 3 weeks were really bad with a unproductive cough, headaches and diarrhea off and on, nausea, body aches. After 2 weeks I was sent to Urgent care to get a Covid test and then they sent me to the Emergency room. and they did an EKG, which showed Pericarditis and chest pains. that was 2 weeks ago and I was told to rest, I'm still having chest pains, headaches and waiting to feel better. No Covid results reported because Urgent care thought ER was doing a test and ER did not do a test because Urgent care did, but Urgent care disposed of their test. Still now well at all.
71 2021-07-07 low platelet count D69.6 - Thrombocytopenia, unspecified
71 2021-07-08 heart rate decreased I had the first dose on 1/14/2021 and experienced diarrhea and slight vomiting that night and next d... Read more
I had the first dose on 1/14/2021 and experienced diarrhea and slight vomiting that night and next day. Other than a sore arm I felt ok after that until 1/28/2021. After making dinner that evening I suddenly experienced stroke like symptoms. My husband called 911 and I was taken to the ER via ambulance. My heart rate was down in the 30s and 40s. I was monitored and a heart surgeon was called in. He said I needed a pacemaker if I wanted to continue living. The next morning I received a temporary pacemaker and two days later received a permanent unit.
71 2021-07-10 loss of consciousness Less than24c hours after receiving dose 2: I was feeling only tired with no other symptoms. I had s... Read more
Less than24c hours after receiving dose 2: I was feeling only tired with no other symptoms. I had slowly walked through my living room for abut 10 -12 steps and suddenly with no warning of any type I just passed out. I have never done this in 71 years. I ended up with a bruised knee (no apparent other damage to knee) and a bruised and cut chin, broken tooth, two chipped teeth and undetermined yet possible chin bone damage. I am having the tooth pulled completely this week, bone grafting and implant placed as it is tooth #12 toward front and needs support. The other two chipped teeth require bonding. The chin bone still feels a little off and tender in one spot. Until the other tooth comes out I do not know if the bite is a problem which would indicate possible jaw damage also. My big concern is this "free" shot could cost me several thousand dollars before they are done! Is there any place to get help paying for the damage repairs?
71 2021-07-11 blood pressure increased Elevated blood pressure since receiving first dose.; This spontaneous case was reported by a consume... Read more
Elevated blood pressure since receiving first dose.; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated blood pressure since receiving first dose.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. Concurrent medical conditions included Bone cancer. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Elevated blood pressure since receiving first dose.) (seriousness criterion death). The patient died on 13-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: high (High) Elevated blood pressure. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. Company Comment: Very limited information regarding the event has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received on 07 Jul 2021 included relevant history detail (bone cancer), seriousness (death) and outcome of the event (fatal).; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death
71 2021-07-11 chest pain, pulmonary embolism Pt was admitted to the hospital on 7/9/21 c/o pleuritic chest pain and was diagnosed with a Left sid... Read more
Pt was admitted to the hospital on 7/9/21 c/o pleuritic chest pain and was diagnosed with a Left sided pulmonary emboli. Because of her history of cerebral aneurysms she was treated cautiously with lovenox/Coumadin bridging at the direction of neurology. She was discharged home on 7/12/21 to follow up with her primary care with close blood work monitoring. Her venous dopplers were negative for deep vein thrombosis. She has no prior history of blood clots, does not take birth control, no family hx of blood clots, does not smoke, has had no recent/prolonged immobility or travel and no recurrence of cancer that has been in remission for 8 years, no obesity.
71 2021-07-13 fainting The first thing that started was extreme chills. I also felt light headed which resulted in faintin... Read more
The first thing that started was extreme chills. I also felt light headed which resulted in fainting. I also had a little nausea. I felt okay the morning after the vaccine. I did have to get stiches due to my fall from fainting. I feel like if I would have stayed in bed instead of getting out of bed I would have been fine. I did go to Hospital for my stiches in my head.
71 2021-07-15 haemoglobin decreased Internal bleeding (black, terry stool), fatigue. Second vaccine injection received 02/19/2021 @ 1:0... Read more
Internal bleeding (black, terry stool), fatigue. Second vaccine injection received 02/19/2021 @ 1:00PM. On 02/20/2021 emergency in-oatient hospitalization following days of weakness. Hemoglobin 3.7 g/DL. Diagnosis of colorectal cancer and subsequest colectomy. Non-responsive hemoglobin recovery after multiple transfusion. Diagnosis of MDS on 04/20/2021. Began Vidaza (sub-Q) treatment on 06/01/2021. Continued transfusions every ~10 days. Referred to Clinic for 2nd opinion. Search in progress for donor for bone marrow transplant.
71 2021-07-19 cerebrovascular accident I had a stroke 4 days after second vaccine
71 2021-07-19 cerebrovascular accident mini stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBR... Read more
mini stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (mini stroke) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (mini stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (mini stroke) outcome was unknown. Concomitant medications were not reported. The reporter stated that, the patient had receive the second dose, and experienced a mini stroke within two weeks. Treatment medications were not reported. Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
71 2021-07-20 heart rate increased, atrial fibrillation Felt like I was at my lifes end; more Afib eposides; Still weaker; I was so ill with vaccine one; fe... Read more
Felt like I was at my lifes end; more Afib eposides; Still weaker; I was so ill with vaccine one; feel pain; heart rate increased; intentional dose omission; threw up; chill/severe chills; Was tired / tired all the time; fever; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (Felt like I was at my lifes end) and ATRIAL FIBRILLATION (more Afib eposides) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer and Lymphadenectomy. Concurrent medical conditions included Hypertension (More episodes), Atrial fibrillation (high blood pressure) and Thyroid disorder. Concomitant products included RIVAROXABAN (XARELTO) for Atrial fibrillation, METOPROLOL, OXYBUTYNIN HYDROCHLORIDE (OXYBUTIN) and LEVOTHYROXINE for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chill/severe chills) and FATIGUE (Was tired / tired all the time). On 12-Apr-2021, the patient experienced VOMITING (threw up). On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (Felt like I was at my lifes end) (seriousness criterion medically significant), ATRIAL FIBRILLATION (more Afib eposides) (seriousness criterion medically significant), ASTHENIA (Still weaker), ILLNESS (I was so ill with vaccine one), PAIN (feel pain), HEART RATE INCREASED (heart rate increased) and INTENTIONAL DOSE OMISSION (intentional dose omission). The patient was treated with ACETAMINOPHEN on 11-Apr-2021 for Fever, at an unspecified dose and frequency. On 11-Apr-2021, PYREXIA (fever) had resolved. On 13-Apr-2021, CHILLS (chill/severe chills) had resolved. At the time of the report, NEAR DEATH EXPERIENCE (Felt like I was at my lifes end), ATRIAL FIBRILLATION (more Afib eposides), ILLNESS (I was so ill with vaccine one), PAIN (feel pain), VOMITING (threw up), FATIGUE (Was tired / tired all the time), HEART RATE INCREASED (heart rate increased) and INTENTIONAL DOSE OMISSION (intentional dose omission) outcome was unknown and ASTHENIA (Still weaker) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Heart rate: fast (High) Fast. On an unknown date, Heart rate: irregular (abnormal) Irregular. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Patient was still weaker and could mow tiny yard in 12 minutes but now takes 35minutes. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient stated of still being weaker and tired all the time, was so ill with vaccine one and will not take second and felt like was at life end and firmly believe it cause to have more Afib episodes that actually felt pain with them now. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Additional information includes-reporters address, patients-race, height and weight, patient history-thyroid, Indication for concomitant medication Xarelto and added the events and case upgraded to serious; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
71 2021-07-20 hypotension, inflammation of the pericardium, chest discomfort, heart rate increased JANUARY 16-18, 2021: headache, fatigue, sore arm. JANUARY 27, 2021: extremely fatigued. FEBRUAR... Read more
JANUARY 16-18, 2021: headache, fatigue, sore arm. JANUARY 27, 2021: extremely fatigued. FEBRUARY 5-15, 2021: difficulty breathing, extreme fatigue, heavy chest; collar, neck and head pain; weak; chronic headache; accelerated heart rate (100-115 bpm), low blood pressure (approx. 80 systolic), and mild fever (99-100.9 degrees), especially in evenings. FEBRUARY 9, 2021: 1st visit to Hospital ER diagnosed as arrhythmia due to accelerated HR and sent home with metoprolol to lower blood pressure and eluquus to thin blood. FEBRUARY 10-14: above symptoms persist. FEBRUARY 15, 2021: Symptoms worsen, return to ER. FEBRUARY 17-19, 2021: admitted to hospital; diagnosed with and treated for fluid on heart sac (pericarditis) and left lung (drained on 2/18/21). FEBRUARY 19, 2021: Released
71 2021-07-22 blood clot Developed a blood clot in left leg
71 2021-07-25 heart flutter Fever, chills, muscle aches, headache first couple of days. Continued symptoms minus fever for at l... Read more
Fever, chills, muscle aches, headache first couple of days. Continued symptoms minus fever for at least 2 more weeks. My hands would become ice cold and numb. Moving forward I still have the headache, very intense at times, plus brain fog, joint and muscle aches more than usual, heart fluttering waking me at night, vision blurred and double vision, fatigue, feeling like my legs are so heavy I can?t move forward, dizzy when bending over and winded when walking a short distance. I am normally an active, healthy senior who manages a small farm on my own and prior to the pandemic, I was a part time stock clerk.
71 2021-07-25 chest discomfort patient reported chest heaviness and like weighted and felt like heart was tight and pressured brea... Read more
patient reported chest heaviness and like weighted and felt like heart was tight and pressured breathing hard patient contacted primary care dr and did make appointment to doctor . referral made to cardiologist three days after that and before appointment made symptoms resolved. symptoms were 10 days or so total
71 2021-07-27 excessive bleeding I am bleeding & bruising & the bruising just appears I am not hurting myself or anything & if I get ... Read more
I am bleeding & bruising & the bruising just appears I am not hurting myself or anything & if I get a scratch or little cut it bleeds for several hours. I am now on Cyclophosphamide & prednisone
72 2020-12-31 blood pressure decreased, hypotension Following administration of vaccination, the patient was reported to have experienced a drop in bloo... Read more
Following administration of vaccination, the patient was reported to have experienced a drop in blood pressure within 15 minutes of the vaccination. BP was reported by the nurse to be 80/50. Patient was alert and reported feeling well despite the hypotension. The patient was placed under further observation.
72 2021-01-05 chest pain Chest pain, itching . Pt transported to ER per EMS
72 2021-01-06 chest discomfort itching, chest tightness, dizziness, shortness of breath no angioedema or anaphylaxis
72 2021-01-14 blood pressure increased, heart rate increased tingling sensation side of jaw; tingling sensation inside the mouth; tingling sensation inside toung... Read more
tingling sensation side of jaw; tingling sensation inside the mouth; tingling sensation inside toungue; blood pressure went up; pulse went up; A spontaneous report was received from a nurse who was also a 72 years old, female patient who experienced the serious events of a tingling sensation in the side of her jaw, inside her mouth, and tongue, and also had an increase in blood pressure and pulse rate. The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter. On 26 Dec 2020, approximately 5 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 039K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. The patient reported she received the Moderna vaccine on 26 Dec 2020 and after 5 minutes, she experienced tingling in the side of her jaw, inside of her mouth, and tongue. She described it as "like getting a Novocain injection." She was rushed to the ER and then suddenly her blood pressure and pulse went up. A CT scan of the brain was performed, and per the patient, symptoms were somehow resolved. She was advised by her primary care physician that she cannot get the second dose of the vaccine based on her reactions. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events, tingling sensation in the side of her jaw, inside her mouth, and tongue, and had an increase in blood pressure and pulse rate were considered resolved on 26 Dec 2020.; Reporter's Comments: This case concerns a 72 years old, female subject, who experienced a serious unexpected event of jaw disorder, paraesthesia, paraesthesia oral, and non-serious unexpected event of blood pressure increased and heart rate increased. All the events occurred after 5 mins of mRNA-1273 (Lot# 039K20A) vaccine administration. The subject was treated in ER (details not provided). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
72 2021-01-15 heart rate increased Increased Heart Beat for about 2 hours on 1/13 and again on 1/16. Contacted dr. Office and they ... Read more
Increased Heart Beat for about 2 hours on 1/13 and again on 1/16. Contacted dr. Office and they said to file this report.
72 2021-01-16 chest discomfort, palpitations Shortness of breath - difficulties getting a full breath Feeling of tightness in chest Extreme fatig... Read more
Shortness of breath - difficulties getting a full breath Feeling of tightness in chest Extreme fatigue Heart palpitations Occasional shakiness Slight discomfort in abdominal organs
72 2021-01-19 blood pressure increased Patient sent to express care via w/c after receiving 1st dose of Covid-19 vaccine due to complaints ... Read more
Patient sent to express care via w/c after receiving 1st dose of Covid-19 vaccine due to complaints of dizziness and elevated BP readings. Staff nurse reports patients BP was elevated and c/o dizziness voiced. Dr and NP notified of patient's vital and status. Blood pressure readings were 200/100. Patient was taken to the ED for further care. BP monitored every 15 minutes x 1 hour and EKG performed. Patient sent to ER via w/c escorted per nurse due to elevated BP.
72 2021-01-20 chest discomfort immediate after the injection I had tightness in my chest and wheezing relieved by Albuterol , norma... Read more
immediate after the injection I had tightness in my chest and wheezing relieved by Albuterol , normal pain up until day 6. In a matter of 3 hours I went to the ER because the swelling, pain and itching was severe. Pain radiated to my shoulder and below my scaplua. ER thought I may have a cellulitis stated on Keflex. On day 8 went back to Walk in because the pain was still there but itching was severe. Started on Prednisone, Vistaril, and Risaquad. I continue to have pain in my arm, shoulder and back and some itching . the rash area is discolored brownish and very dry.
72 2021-01-20 loss of consciousness Patient passed out a few minutes after her vaccine. "Patient hard to wake with verbal and mild shak... Read more
Patient passed out a few minutes after her vaccine. "Patient hard to wake with verbal and mild shaking. Provider applied ice packs to chest and face. Patient came became more verbal and was able to speak and rink water. Patient was observed longer by provider. During this time the patient reported her tongue was swelling and throat felt funny. Provider ordered we administered Diphenhydramine 25 mg IM. EMS was called and patient was transported to area hospital.
72 2021-01-20 fast heart rate worked up in ED at Medical Center (location where vaccine was administered) for fatigue, dizziness, ... Read more
worked up in ED at Medical Center (location where vaccine was administered) for fatigue, dizziness, tachycardia. Received IVF. Elevated WBC, possibly sepsis & UTI rather than vaccine reaction. Patient transferred to another Hospital for admission.
72 2021-01-21 nosebleed Had a nose bleed. Patient didn't know if related or not. Does not normally have nose bleed. She con... Read more
Had a nose bleed. Patient didn't know if related or not. Does not normally have nose bleed. She contacted her local GP and they were going to keep a watch on it. At the time of discussing it with her, it had resolved. Continuation page would not allow typing so.... 9. Vitamin b12
72 2021-01-22 fainting Dizziness ..nausea..diarrhea.. faintness
72 2021-01-24 heart rate abnormal febrile, achey, "missed heart beats" on 1/22, went to ED on 1/23 to r/o anything acute and feels be... Read more
febrile, achey, "missed heart beats" on 1/22, went to ED on 1/23 to r/o anything acute and feels better now
72 2021-01-25 heart rate increased 01/19/2021 FELT DIZZY, ELEVATED HEART RATE,153, THROAT FELT LIKE IT WAS GETTING TIGHT 1/20/2021 WENT... Read more
01/19/2021 FELT DIZZY, ELEVATED HEART RATE,153, THROAT FELT LIKE IT WAS GETTING TIGHT 1/20/2021 WENT TO ER
72 2021-01-26 heart rate increased One hour following the injection she became itchy (scalp, ears, face, hands & legs). Called her phy... Read more
One hour following the injection she became itchy (scalp, ears, face, hands & legs). Called her physician and was instructed to take Benadryl. Took one tablet a day until 01/25/2021 when the itching stopped. On 01/24/2021 she began to experience rapid heart beat.And still is experiencing it today periodically. No history of heart problems. Also experienced tingling of right hand and toes one hour after the injection. Still has these symptoms.
72 2021-01-27 chest discomfort Intermittent feelings of unrest, chest tightening, and heaviness in arms
72 2021-01-27 fainting 3 or more instances of syncope/lightheadedness
72 2021-01-29 palpitations The day after I got the shot, I was driving and all of a sudden my heart raced and I got VERY dizzy... Read more
The day after I got the shot, I was driving and all of a sudden my heart raced and I got VERY dizzy and my vision was darkening. I also had ringing in my ears. I felt like I was going to pass out. It scared me. I put on my brakes and started to pull over but by the time I started to pull over, the dizziness was slowly starting to clear up. I had a "foggy" feeling in my head for about a half hour after so I went to my friend's house and sat down and drank some water. Then I went home. I have had no incidents since then.
72 2021-01-31 blood glucose increased Patient had complaints of dizziness, being unsteady on her feet, elevated blood sugar, and increased... Read more
Patient had complaints of dizziness, being unsteady on her feet, elevated blood sugar, and increased confusion. While at dialysis she developed worsening confusion and change in LOC and running temp. She was sent to the ER
72 2021-01-31 chest discomfort I asked her to wait 30 minutes due to her other allergies and right at 30 minutes after the vaccine ... Read more
I asked her to wait 30 minutes due to her other allergies and right at 30 minutes after the vaccine injection she reported "feeling strange with a little pressure in her chest. 11:30 B?P 180/100 pulse 80 resp 20 she was alert and oriented 11:40 B/P 170/100 pulse 80 Resp 16 alert and oriented. 11:43 she too Nitroglycerine 0.4mg sublingual - She had this in her purse and followed it up with 2 aspirin 81mg and she chewed these. Ambulance had been called due to the history of CAD and HTN and they arrived at 11:47 . They took her B?P and it was 160/110 and the decision was made to transport her to the hospital for further assessment.
72 2021-01-31 hypertension Patient felt like she was getting a headache or light headed 15mins after vaccinations, She took al... Read more
Patient felt like she was getting a headache or light headed 15mins after vaccinations, She took all of her daily meds this morning and ate breakfast. VS at 11:30 were 159/87 P 84 o2sat 98. Had patient sit for 15 more min and gave her water. Was talking to her and she seemed fine and she reported headache had gone away. Life was very stressful recently. VS at 11:45 were 176/98 P 82 O2sat 99. She felt better and felt safe to go home. She is a healthcare worker and can f/up with PCP re high BP later.
72 2021-01-31 hypertension high blood pressure, hives, light headedness and slight fever. patient didn't take anything till 1/3... Read more
high blood pressure, hives, light headedness and slight fever. patient didn't take anything till 1/31 at about 9 am patient took Tylenol fever was as 100.8
72 2021-01-31 loss of consciousness Diarrhea and vomiting beginning 1 am January 31, 2021 - passed out on way to bathroom - extreme chi... Read more
Diarrhea and vomiting beginning 1 am January 31, 2021 - passed out on way to bathroom - extreme chills - lasted approximately 2 hours. Chills continued for approximately 12 hours.
72 2021-02-03 hypotension 30 minutes post vaccine administration the patient became hypotensive, diaphoretic, and had shallow ... Read more
30 minutes post vaccine administration the patient became hypotensive, diaphoretic, and had shallow respirations. Patient was on dialysis treatment at the time and was rinsed back with 500 ml NS, placed on 2L O2 via NC, and given 1 dose of epi IM. Patient responded well to interventions and was alert and oriented prior to arrival of EMS. EMS arrived to evaluate the patient. Patient's daughter arrived to take patient to ER to be evaluated.
72 2021-02-03 loss of consciousness Chills and headache the night of the injection. Next morning at 6:00 was sitting up in bed and beca... Read more
Chills and headache the night of the injection. Next morning at 6:00 was sitting up in bed and became unconscious and unresponsive to painful stimulus. Called 911 medics. After about 20 minutes - started to regain conscious. At that point Bp was 50/40. Taken to Hospital . Vomiting and Diarrhea. Was given 1 bag IV saline and adavan. Release after 4 hours.
72 2021-02-03 fainting Metallic taste in my throat...immediately. Light headed and faint within a minute. Foggy thinking... Read more
Metallic taste in my throat...immediately. Light headed and faint within a minute. Foggy thinking, slight fever, fatigue. Two and 1/2 days later, swollen arm below the shot site, red, itchy, hot and sensitive to the touch.
72 2021-02-04 ischemic chest pain, blood pressure increased Severe angina. has not had an episode of angina in a very long time. This was the first time she h... Read more
Severe angina. has not had an episode of angina in a very long time. This was the first time she had to use Nitro in years. She took one dose, and three chewable 81 mg aspirin, and the symptoms subsided. Blood pressure peaked 158/80 with a pulse of 69. When the symptons subsided, no further action was taken.
72 2021-02-04 platelet count decreased, low platelet count Thrombocytopenia/lowplatelet; A spontaneous report was received from a caregiver concerning a 72-yea... Read more
Thrombocytopenia/lowplatelet; A spontaneous report was received from a caregiver concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced thrombocytopenia/low platelet count. The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Jan 2021 at 04:00 pm, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient was hospitalized for thrombocytopenia/low platelet count, the patient was in emergency room and was given a strong dose of steroid. Her body did not react to it and she was then given a platelet transfusion. The doctors have given her steroids, immunoglobulin and aminocaproic acid during the hospitalization. They were discussing the next steps of therapy and plan to try rituximab. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event thrombocytopenia/low platelet count was unknown.; Reporter's Comments: This case concerns a 72-year-old, female patient, who experienced a serious unexpected event of thrombocytopenia. This event occurred 2 days after first dose of mRNA-1273, lot # unknown. Treatment included steroids, platelet transfusion, immunoglobulin, Amicar and pending treatment with Rituximab. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
72 2021-02-05 blood pressure increased, arrhythmia Went into arrhythmias and blood pressure was elevated for 3 hours. took extra dose of metoprolol an... Read more
Went into arrhythmias and blood pressure was elevated for 3 hours. took extra dose of metoprolol and both arrhythmia and blood pressue came down slowly during the subsequent 3 hours
72 2021-02-05 loss of consciousness About 1/2hour after I got up, I started feeling off with vision issues. Next thing I knew I had pas... Read more
About 1/2hour after I got up, I started feeling off with vision issues. Next thing I knew I had passed out and was laying on the floor. Then severe sweating with a headache and tiredness. My left arm was quite sore.
72 2021-02-06 blood pressure decreased My tongue began to burn and it increased in intensity and spread to the back of the mouth and throat... Read more
My tongue began to burn and it increased in intensity and spread to the back of the mouth and throat. I had pre-treated with an allegra. I stopped and took a Benedryl capsule and turned around and returned to the health facility. The nurses watched me for another 45 minutes during which time nothing else occured. My blood pressure was slightly depressed but not too much. It was 98/ 76 when normal for me with medication is 116- 128 over about 86=92. I took another Benedryl when I was close to home. The burning continued but did not progress into swelling. It did feel as if I had sores in my mouth that night but they were gone in the a.m. I felt like my tongue had been burned by much too hot food and/or beverage.
72 2021-02-07 fast heart rate headache, rapid heart rate for several hours (160s), nausea, joint aches, chills, dizziness, weaknes... Read more
headache, rapid heart rate for several hours (160s), nausea, joint aches, chills, dizziness, weakness. Worst part lasted 48 hours. The nearest ER is an hour away so just pushed thru it.
72 2021-02-08 loss of consciousness, blood glucose increased I found her unresponsive in her room, she had some white stuff on her mouth. I called 911. while wai... Read more
I found her unresponsive in her room, she had some white stuff on her mouth. I called 911. while waiting I placed ice on the back of her neck and she began to respond, as she began to become more responsive she defecate all over herself. I checked her blood sugar it was 159. The ambulance arrived, they checked her vitals said they were ok, they gave me the option of monitoring her at home or going to the ER. I chose to monitor her at home. Monday all day she still had a fever complaining of headache, joint pain and pain in the arm she received the vaccine, at times she became very delirious, nothing she said made sense. . Her doctor said she had a seizure and offer to place her on seizure medication. I gave her two 500mg Tylenol she has an appointment on March 7th for the second dose but I am afraid to give her the second dose.
72 2021-02-09 blood pressure increased Very severe left arm pain, throbbing along entire course of humerus bone and down ulna/radius into w... Read more
Very severe left arm pain, throbbing along entire course of humerus bone and down ulna/radius into wrist. Pain was so severe my blood pressure shot up very high, I couldn't stop hyperventilating, and my husband had to take me to the emergency room. They gave me dilaudid and a prescription for Percocet. An X-ray was taken which showed only pre-existing arthritis of shoulder joint. My doctor told me this was very characteristic of "Covid Arm" others had experienced with the Moderna vaccine.
72 2021-02-09 chest pain Upon awakening the next day, I began to have extremely painful deep chest spasms starting in outer r... Read more
Upon awakening the next day, I began to have extremely painful deep chest spasms starting in outer right side ribs and quickly radiating under breast and up into nipple. Happened in a succession of maybe 2-3 spasms then stopped. Occurred maybe 6 times over the course of about 5 hours, then totally stopped around the 24 hour mark of the injection.
72 2021-02-10 heart rate increased Woke up at 1:00 am with extremely rapid heart beat?130 bpm. It did not subside so I contacted the ph... Read more
Woke up at 1:00 am with extremely rapid heart beat?130 bpm. It did not subside so I contacted the pharmacy who suggested I notify my doctor. I visited his office at 2:00 pm. He ran an EKG. It was normal so gave me a prescription for a beta blocker. After taking that, my heart rate returned to normal. I also had a slight fever, body aches & headache.
72 2021-02-10 ischaemic stroke Patient received vaccine during working hours on 2/10/2021. Coworkers reported patient was acting a... Read more
Patient received vaccine during working hours on 2/10/2021. Coworkers reported patient was acting abnormally this morning upon arriving to work. After medical assessment and testing, patient was diagnosed with a ischemic stroke and transferred to higher level of care.
72 2021-02-10 palpitations slight numbness around jaw and down sides of neck, heart beat racing ( it lasted about 10 minutes)
72 2021-02-11 heart rate increased When the needle was being removed started shoulder pain from top of shoulder to the elbow. Got hot ... Read more
When the needle was being removed started shoulder pain from top of shoulder to the elbow. Got hot all over from inside out, nausea , weakness, chills within first 2 minutes. headache, fast heart beat, and tiredness. Still chilling and a small headache after 3 days.
72 2021-02-12 chest discomfort pressure in chest, fatigue, body heat, mild sore throat
72 2021-02-12 chest pain, chest discomfort, blood pressure increased Patient was instructed to stay for observation for 30mins due to reported allergies. Approx 20mins a... Read more
Patient was instructed to stay for observation for 30mins due to reported allergies. Approx 20mins after patient reported chest tightness/burning sensation in lungs/center of chest. Pt declined any signs of heart attack and no lightheadedness, swelling of tongue or throat or shortness of breath; and no hives. Patient took Benadryl 25mg tab, used cold cloth/ice pack on neck, drank water. Dose of Benadryl 25mg repeated in 25mins per patients preference. After 1 hour, patient reported just a slight burning in center of chest and took a dose of tums. Still no hives. Patient was comfortable going home at 5:10pm (husband driving)
72 2021-02-13 inflammation of the pericardium, palpitations, ischemic chest pain, chest discomfort Day 1: headache and chills, no fever. Day 2: fatigue and chills, no fever Day 3-4 : fatigue... Read more
Day 1: headache and chills, no fever. Day 2: fatigue and chills, no fever Day 3-4 : fatigue and chills, no fever Day 5: Strong heart palpitations, chills and fatigue . Day 6-7 Heart pain, palpitations, chills and fatigue/ Had to rest constantly. Began taking ibuprofen to calm the inflammation. Day 8: Heart pain, pressure & palpitations worsening, fatigue. Primary and Cardiologist recommended going to ER. Diagnosed with mild pericarditis. Day 9-10: Home on bedrest taking ibuprofen 3x day with continued heart palpitations, pain, chils and fatigue.
72 2021-02-14 body temperature decreased That afternoon I walked, but cut it off at just over 2 miles as I was getting tired. Around 6 I had ... Read more
That afternoon I walked, but cut it off at just over 2 miles as I was getting tired. Around 6 I had bad chills, a low fever 99.9, Around 8 nauseous and headache, 9:30 I started throwing up with urination at the same time.. This happened maybe 4 times until around 3 am.. I was really weak. Over temp around 101. On 29th: Took 2 Advil and kept the water down. Slept all day and weak, Hurt all over especially the entire left arm and hips. Temp 102.6 overnight.. On 30th, Temp stayed just over 100, took Advil, ate soup and slept most of day. Around 4 pm temp down to 99. On 31th, Sunday, I will could do much, but did sit up much of day and ate light meal. Fever broke in the afternoon. I did not call a doctor as I always thought I would be better soon. On Monday, Feb 1, I went for my previously scheduled Mammograms. The next day I received a call that I needed to come back. When I went in on the 8th for more mammogram views and ultrasounds, they found 3 places of concern. I am scheduled for a needle biopsy on this Thursday.. I told them that I had received my Covid19 vaccinations and they mentioned that they have seen differences in tissue after the shots. I did not see a doctor on the first and not sure if the breast tissue or mass is a consequence or not.
72 2021-02-14 chest pain Woke up at 7 a.m. and had a very, very hard time breathing. When I could get a breath it hurt all o... Read more
Woke up at 7 a.m. and had a very, very hard time breathing. When I could get a breath it hurt all over my chest and back. Had slight fever. The right side of my chest really hurt.
72 2021-02-14 deep vein blood clot Deep Vein Thrombosis, both legs below knee 11 days after first vaccine injection
72 2021-02-14 fainting, hypotension As I was administering the vaccine, the patient stated: "I feel" and then fainted on me. Her husband... Read more
As I was administering the vaccine, the patient stated: "I feel" and then fainted on me. Her husband and I kept trying to get her to talk to us, she was squeezing my hand as we talked, I ran an alcohol pad under her nose. We got her to open her eyes a few times and decided to call 911. She was breathing and I could feel her pulse. 911 had us lay her on the floor where she started to come to and mentioned how bad her vertigo was before I gave the shot. She also said her blood pressure was really low this morning and didn't want us to call the news as she didn't want to be on the news
72 2021-02-14 fainting Almost fainted 24 hours post injection mild dizziness for about 2 0 minutes Redness, swelling and it... Read more
Almost fainted 24 hours post injection mild dizziness for about 2 0 minutes Redness, swelling and itching day 8 post injection
72 2021-02-15 blood pressure fluctuation Fluctuating blood pressure, Premature Atrial Contractions, Shingles. Metoprolol Tartrate 25 mg. 2 t... Read more
Fluctuating blood pressure, Premature Atrial Contractions, Shingles. Metoprolol Tartrate 25 mg. 2 times a day along with the Lisinopril 40 mg. for blood pressure issues. Antibiotic for Shingles for 7 days. Finished antibiotic and threw bottle in trash
72 2021-02-15 fast heart rate Patient described "swelling of throat", tachycardia, flushed. Nurse and paramedic collected vitals, ... Read more
Patient described "swelling of throat", tachycardia, flushed. Nurse and paramedic collected vitals, nurse administered diphenhydramine HCL liquid 70mg PO at 10:10am. Patient was improving within minutes, and decision to transport via standby ambulance to local hospital ER less than a mile from clinic. Coordinator spoke with ER - patient received dexamethasone and was discharged, already improved by arrival to ER per nurse. Spoke to patient at 4:30pm - reports return to normal, will not be seeking boost dose.
72 2021-02-16 blood pressure increased Severe flu like symptoms. Elevated blood pressure. Pain all over.
72 2021-02-16 chest discomfort About 7 minutes after the injection my upper chest became tight. I went to the nurse and described ... Read more
About 7 minutes after the injection my upper chest became tight. I went to the nurse and described my symptoms. She gave me a bottle of water and when I took a few sips I noticed that my throat also felt tight. I was the given 25mg of Benedryl. My symptoms went away after about 10 minutes. I stayed for about 35 minutes after I received the injection to make sure I was OK to drive home symptom free.
72 2021-02-16 chest pain Moderna Covid-19 EUA I had extreme pain and swelling in my left arm, shoulder, chest, and back. C... Read more
Moderna Covid-19 EUA I had extreme pain and swelling in my left arm, shoulder, chest, and back. Could not raise my arm without more pain. This lasted about 24 hrs. Started subsiding after the 24 hrs. and was gone after 48hrs.
72 2021-02-16 loss of consciousness pt stood up on her own after receiving Moderna vaccine and lost consciousness for approximately 5 mi... Read more
pt stood up on her own after receiving Moderna vaccine and lost consciousness for approximately 5 minutes. EMS was called and pt monitored. pt was breathing on her own. EMS evaluated and decided pt did not need further monitoring or care and left pt to travel home on her own. pt left pharmacy with escort to her vehicle
72 2021-02-17 chest discomfort 48 hours after my first vaccine I started having a vaginal discharge that appeared the color of milk... Read more
48 hours after my first vaccine I started having a vaginal discharge that appeared the color of milky tea. No obvious bleeding, no cramps, no itching, no odor, no rash or other symptom. It required me to change a panti-liner 6-7 times qd for seven days. Sometimes it was absorbed by the pad, sometimes it appeared to be like jelly. At the same time I started to feel symptoms of a cold; chest pressure, increased fatigue, mild headache, joint discomfort. Oral temp was 100.2 F. usual is 96.4-97.6F. Later I woke with a night sweat, my body and the sheets were soaked but I was too tired to change them. The next morning I felt fine. Only the vaginal discharge continued unchanged for one week. Hx complete hysterectomy.
72 2021-02-18 heart rate increased Extreme heat, dizzy, impaired vision, rapid heart beat, nausea, weakness, headache
72 2021-02-18 hypotension Hypotension, shortness of breath, pruritic skin rash, generalized weakness, decreased urine output a... Read more
Hypotension, shortness of breath, pruritic skin rash, generalized weakness, decreased urine output and fatigue beginning the day after the vaccination with worsening symptoms over the next 5 days. The patient reported dizziness, lightheadedness, and two falls. The patient was hospitalized on 02/10 and was treated with calamine lotion, cetirizine, diphenhydramine, famotidine, hydroxyzine, loratadine, and methylprednisolone. On 2/12 the patient had worsening itching, shortness of breath, and oxygen saturations of 92% and was given supplemental oxygen, IV diphenhydramine, and IV methylprednisolone.
72 2021-02-18 palpitations, hypertension 4 days after being given the Moderna vaccine (Feb 6th), I had extensive racing of my heart that mad... Read more
4 days after being given the Moderna vaccine (Feb 6th), I had extensive racing of my heart that made me feel faint. It lasted a good 6 hrs. Next day (feb 7th), I had the same issue three different times during the day. Third day, ( Feb 8th) same racing of the heart in the morning. I then called the cardiologist, and he had me come in the next day, (Feb 9th). He took my blood pressure three different times and it registered over 160 /SYS. I have had blood work, nuclear stress test, ECHO and wearing a heart monitor for a month. All are normal. In all my years, I have never had racing of the heart or any blood pressure problems. I am a very health woman. I have had no more of these events (racing of the heart and high blood pressure ) since February 10th. Coincidence????? I don?t think so. Now I am scheduled for the second Moderna vaccine on March 1, 2021.
72 2021-02-19 blood pressure increased After vaccination and doing 20 wall push ups, I went to bathroom and noticed red flushing of face an... Read more
After vaccination and doing 20 wall push ups, I went to bathroom and noticed red flushing of face and chest. I then took 2 Tylenol. I notified Nurse Practitioner who had me go to separate room for monitoring and questioning. My blood pressure had risen to 144/70?. SaO2 97% and HR 82. In 5 min., it was down to 120/70 (normal for me). Then after walking in another 5 min. it was back up to 138/?. The flushing was lessening and I left in@ 30 min. to go grocery shoppping and home. I home I took 2 Benadryl and went to bed early. I awoke with just the sore left shoulder and better throughout day.
72 2021-02-19 loss of consciousness Tuesday am: I woke up the next morning after the shot, feeling fine. I went to have my hair done aro... Read more
Tuesday am: I woke up the next morning after the shot, feeling fine. I went to have my hair done around 10am and then by 11am it hit me hard. It began with vomiting and then I passed out. The next thing I recall I was on my home couch around 8pm feeling very weak. I'm told my husband came to get me.- It wasn't until today, Saturday, that I am starting to feel somewhat better. Still a little weak, but able to take of myself.
72 2021-02-19 palpitations Moderna Covid 19 Vaccine EUA Rt arm down to fingers hurt about 20 minutes after shot. BP went to 1... Read more
Moderna Covid 19 Vaccine EUA Rt arm down to fingers hurt about 20 minutes after shot. BP went to 170/126, heart racing, clammy feeling, unwell 2 children's Bendryl taken , I stayed at facility for 1 1/2 hrs until my BP went down, EMT took BP., oxyimetry and heart rate during that time.
72 2021-02-19 palpitations Heart palpitations
72 2021-02-20 lightheadedness About 30 minutes after getting vaccine, when I was told I could go...I experienced extreme faintness... Read more
About 30 minutes after getting vaccine, when I was told I could go...I experienced extreme faintness. I made it to my and home, but could not get out of car after arriving. Eventually I did, but could barely move and dropped everything at my door. Could not undress because I let so faint. Then I started feeling cold. Made it to a chair and slept there about 5 hours before everything went away. I had rad all possible side-effects, but did not see feeling lightheaded and almost fainting or fainting on the list.
72 2021-02-21 heart rate increased 1:05PM SLIGHT SOB, FACE FLUSHED, FEELS NERVOUS. NO DYSPNEA NO TROUBLE SWALLOWING. 1:06PM BENADRYL ... Read more
1:05PM SLIGHT SOB, FACE FLUSHED, FEELS NERVOUS. NO DYSPNEA NO TROUBLE SWALLOWING. 1:06PM BENADRYL 50MG GIVEN P.O. HR 112, O2 SAT 98% 1:35PM SYMPTOMS IMPROVED. HUSBAND TO DRIVE PT HOME. HR 97. NO ACUTE DISTRESS NOTED. (2-10-21 9AM TC - STATES SHE FEELS 'ALOT BETTER'. DOES HAVE SOME CHILLS/ACHES./4PM TC - FELT 'FLUSHED' STATES BP124/64, HR 94 TO 101. STATES SHE CALLED HER CARDIOLOGIST AND TOOK HER METOPROLOL.)
72 2021-02-21 hypertension Felt flush and had hives to arms and chest. Hypertensive at 220/132. Denies any difficulty breathi... Read more
Felt flush and had hives to arms and chest. Hypertensive at 220/132. Denies any difficulty breathing. Negative edema to mouth, face or throat. IV established and 50mg Benadryl given through IV. Transported to hospital.
72 2021-02-23 chest discomfort A headache that began the evening of 2/10 and lasted for 72 hours. Tylenol every 4-6 hours. Labored ... Read more
A headache that began the evening of 2/10 and lasted for 72 hours. Tylenol every 4-6 hours. Labored breathing and heavy chest feeling - began during the night of 2/10 and lasted for two days. Rested and used additional breathing treatment by nebulizer for two days. I also had great deal of fatigue, body aches, joint pain which began the following morning (2/11) and lasted about 24-36 hours. Tylenol helped. A general flu like feeling of blah.
72 2021-02-23 chest pain, chest discomfort Restricted breathing, light-headed, difficulty drawing a deep breath, minor chest pain and feeling w... Read more
Restricted breathing, light-headed, difficulty drawing a deep breath, minor chest pain and feeling weight on chest when inhaling. Increase in mucus production with difficulty clearing plugs.
72 2021-02-23 chest pain 12 hours after first Moderna vaccine,, extreme aches in both arms and feeling of inflammation in ch... Read more
12 hours after first Moderna vaccine,, extreme aches in both arms and feeling of inflammation in chest.. Symptoms lasted an hour before subsiding. Lethargic day after shot. 48 hours after second Moderna vaccine, body rash on upper body, front and back. Redness at site of injection, also on inside of elbows and inside of thighs. No side effects day of vaccine. First day after vaccine had fever(100°) and lethargy. Second day after vaccine, skin rash developed. Did not feel ill with rash.
72 2021-02-23 heart rate increased, hypertension Patient developed intense abdominal cramping, nausea, and rapid heart rate (101) as well as high blo... Read more
Patient developed intense abdominal cramping, nausea, and rapid heart rate (101) as well as high blood pressure (158/88). EMS was called and one dose of EpiPen was given in the left thigh. the patient was then taken to a nearby hospital by EMS.
72 2021-02-25 cardiac failure congestive Developed respiratory distress, hypertensive emergency, and acute congestive heart failure with bila... Read more
Developed respiratory distress, hypertensive emergency, and acute congestive heart failure with bilateral edema of lower legs
72 2021-02-25 chest discomfort, heart rate increased, blood glucose increased pt co rapid heart rate, upper lip and nose numbness and tingling, lightheadedness and shaking. pt g... Read more
pt co rapid heart rate, upper lip and nose numbness and tingling, lightheadedness and shaking. pt given 1 dose of 0.3 EpiPen to right thigh. symptoms progressed to feeling a lump in her throat and chest pressure. initial vital signs were BP 178/83, HR 124, res 24, and 02 sats of 97%. Held 2nd epi dose because HR increased to 146, BP 206/85. 911 activated, pt transported to ED
72 2021-02-25 chest discomfort reaction started 9 days after shot: arm swelling with 2 bruises, itching, small lumps that itched, ... Read more
reaction started 9 days after shot: arm swelling with 2 bruises, itching, small lumps that itched, irritation in chest area, fatigue
72 2021-02-25 loss of consciousness Patient reports running a fever through the night of the 25th. She woke up on the 26th no feeling w... Read more
Patient reports running a fever through the night of the 25th. She woke up on the 26th no feeling well, took her blood sugar which was 142 mg/dL. Shortly after she checked her blood sugar she passed out. Her daughter is a nurse and when she arrived, she checked the patient's blood pressure which was noted to be in the 90s systolic. Shortly after that a re-check of her blood pressure improved to 117/60 . Patient was scheduled to be seen with her primary care provider on the 26th to verify that patient was stable.
72 2021-02-25 fast heart rate Seven minutes after vaccine (10:07 AM) lighheadedness, Tacharida, hives, shortness of breath. Went t... Read more
Seven minutes after vaccine (10:07 AM) lighheadedness, Tacharida, hives, shortness of breath. Went to ER, given Prednisone, Benadryl, Pepcid at 11:00 AM. Discharged at at 12:30 after symptoms subsided. Fatigue present 2/24 and 25. Today is 2/26.
72 2021-02-26 ischemic chest pain, chest pain On Friday, Feb 19th, I started feeling nauseated, and dizzy, on Saturday Feb 20th, I started having ... Read more
On Friday, Feb 19th, I started feeling nauseated, and dizzy, on Saturday Feb 20th, I started having chest pain, I do have angina but the pains have occurred more often since getting the vaccine.
72 2021-02-26 pallor "Covid arm" 3/4 inch diameter around injection site is pale, hard and sore. From the perimeter of t... Read more
"Covid arm" 3/4 inch diameter around injection site is pale, hard and sore. From the perimeter of the pale are out to 2 inch diameter, raised, red rash that itches and is hard and sore.
72 2021-02-28 ischemic chest pain HEART PAIN AND LEFT ARM PAIN, DAY AFTER SHOT FOR 8 DAYS AND STILL OCCASIONAL.
72 2021-03-02 cerebrovascular accident On Monday night, Day 4, I woke at 11 p.m. with chills and shaking, temperature of 99.9 F. Went to th... Read more
On Monday night, Day 4, I woke at 11 p.m. with chills and shaking, temperature of 99.9 F. Went to the bathroom, urinated, took Tylenol and went back to bed. Woke again at 2:00 a.m, still chilled, and tried to stand up and my legs wouldn't hold me. I managed to lift myself to my feet and clutching furniture get to the bathroom, with complete loss of bladder control on the way. Took more Tyleonol, drank more water, put on clean pajamas but couldn't lift my knees to step into them, had to put them on the floor and pull them up. Went to sleep eventually. When I woke at about 5 a.m., all was completely normal. No fever, legs fine, usual bladder control.
72 2021-03-02 nosebleed woke up at 11 pm sunday feb 28 restless which developed into super restless body--almost squirming- ... Read more
woke up at 11 pm sunday feb 28 restless which developed into super restless body--almost squirming- then maniac headache and aches all over, then fever... getting up to 102.4 ( i only took it twice). lasted full bore thru the next day and night. subsided somewhat on tuesday but still strong. woke up wed much better but not great. no executive function. bloody nose added to teh list... sneezes and some cough. NO energy.
72 2021-03-02 haemoglobin decreased Patient presented to ED after her GI specialist referred her for an abnormal hgb level. Patient repo... Read more
Patient presented to ED after her GI specialist referred her for an abnormal hgb level. Patient reported fatigue for past several days but denied any abdominal symptoms or symptoms of bleeding. In the ED, patient's hgb was found to be 5.2. Pt received blood transfusion and was treated with protonix. She underwent an endoscopy and a colonoscopy. Pt was discharged to follow up with GI and PCP
72 2021-03-03 pallor 1418 Patient sitting in general observation and began feeling dizzy/lightheaded. Color pale. Offere... Read more
1418 Patient sitting in general observation and began feeling dizzy/lightheaded. Color pale. Offered water and drank without difficulty. States she is also beginning to feel nauseated. Taken via w/c to private observation area. HR 78; O2 98% on room air. BP 117/75. Had patient remove mask and opened outside doors. Encouraged patient to deep breath. Patient's hands shaky. Denies shortness of breath, throat discomfort, itching. Continued to encourage to drink water. EMT in attendance. 1433: patient states she no longer feels dizzy, but still nauseated and still shaking per bilateral arms, hands. She states that is not normal. Appears to be having chills. BP 100/69; H R 73: O2 96% on room air. States she wants to walk to car, husband present. 1446: Stood independently and assessed . States she does not feel dizzy and ambulated with husband to personal vehicle.
72 2021-03-03 pulmonary embolism, hypertension SOB and HTN on 1/30/21, 3 wks after 1st Covid shot. Submassive acute saddle pulmonary embolism. Pt w... Read more
SOB and HTN on 1/30/21, 3 wks after 1st Covid shot. Submassive acute saddle pulmonary embolism. Pt was sent by ambulance to ER. On arrival, CT revealed a saddle embolism. Heparin was initiated and pt was transported to hospital. Admitted to ICU and bil thrombolytic catheters were placed. On 1/31/21 thrombosis has dissolved. on cessation of thrombolysis and removal of lytic stents on 1/31/21 pt was placed on Xarelto. Pt was D/C on 2/1/21.
72 2021-03-03 fainting about 90 minutes after getting shot I blacked out 3 times over a period of about 40 minutes
72 2021-03-04 chest discomfort wheezing, lip swelling, chest heaviness
72 2021-03-04 palpitations After patient completed 15 minute observation post vaccination started to put her coat on and stood ... Read more
After patient completed 15 minute observation post vaccination started to put her coat on and stood up. Started to feel SOB and felt like was running on a treadmill and felt heart racing. Told observer and taken back to exam room. On the way down the hall stopped in hallway and needed assistance in exam room. B/P elevated 172/74, O2 sats 97% and pulse 130. Patient was instructed to use albuterol that she had in her purse 2 puffs with good effort demonstrated. Patient able to sit alone in chair and stated started t feel better but was feeling anxious. Denies SOB, dizziness, chest tightness and stated has been feeling well. Injection given around lunchtime and patient had not eaten since this am ( coffee and toast). Patient observed for 10 minutes and B/P dropped to 14/76 and pulse 105 and 02 Sats at 98%
72 2021-03-06 heart rate irregular Fever (2 degrees increase), aches, extreme fatigue, lightheadedness, irregular heartbeat. Lasted 24... Read more
Fever (2 degrees increase), aches, extreme fatigue, lightheadedness, irregular heartbeat. Lasted 24-30 hours, then all symptoms were gone.
72 2021-03-07 heart rate abnormal, heart rate decreased Face on right side became very flush along with neck and chest. I asked if this was normal, they th... Read more
Face on right side became very flush along with neck and chest. I asked if this was normal, they then proceeded to take my heart rate and bp. Heart rate down to 41/bp was 169/95 - heart was not functioning normally. I sent to ER to be checked out since i had had a tripple bypass in 2018. They did ekg at site and at hospital. Dr said i was ok but potassium was low they gave me four tablets and then i left. Later in the day, i has an extremely severe headache, nausiated, muscles and bones over entire body ached. On Saturday 3/6 worsened i called the on call doctor. He stated was normal but did treat me for the severe cough and head cold i had along with the reaction to shot. Lasted thru Sunday evening.
72 2021-03-07 heart rate increased aprox 5-7 mins after injection I notice that the right side of my tongue and lips felt different. Th... Read more
aprox 5-7 mins after injection I notice that the right side of my tongue and lips felt different. They seemed to tingle. I called the nurse and she had the attending Dr come to me. Dr checked my airway and said it looks beautiful but wanted me to go next door to the ED. We walked over and checked in. I think my BP was 180/100 and elevated heart rate. Nurse took me to examine room. Dr listened to my heart, checked for rash and looked in my mouth. O2 sat was constant between 96-99%. Heart rate was elevated. Right side of face was a little more flushed than left side. Sensation continued to subside and was gone within the 90 minutes the Dr wanted to contain me. BP was down and HR lower when we left the ED, but not my normal BP No other events. Arm sore at site of injection.
72 2021-03-07 heart rate increased Burning sensation all over body, Itching, throat closing, Throbbing headache, Elevated heart rate. B... Read more
Burning sensation all over body, Itching, throat closing, Throbbing headache, Elevated heart rate. Benadryl 75mg every 3 hours. Albuterol Inhalation Therapy every 3 hours. Plenty of fluids, A course of Prednisone 20mg twice A day for 5 days.
72 2021-03-07 hypertension, palpitations Seven hours after Moderna Vaccine, I experienced rapid heart rate, High Blood Pressure and itching h... Read more
Seven hours after Moderna Vaccine, I experienced rapid heart rate, High Blood Pressure and itching hives under my chin. I called 911 and EMTs checked my vitals & recommended I go to ER. My husband drove me to hospital. But we waited in the car and I did breathing and husband massaged my neck until my BP and pulse were a bit lower. We went home as I did not want to go into ER. The next day, BP and pulse still high, so I called Nurse Line who said to take antihistamine & pain med to lower slight fever. Today, my BP is down to 95/58 but pulse is a little elevated at 97
72 2021-03-07 platelet count decreased, low blood platelet count Acute ITP (idiopathic thrombocytopenic purpura). Presented to clinic with diffuse purpura and petech... Read more
Acute ITP (idiopathic thrombocytopenic purpura). Presented to clinic with diffuse purpura and petechiae. Platelets critical at 33,000.
72 2021-03-08 fast heart rate Feeling tachycardia daily since date of injection of COVID19 vaccine, sometimes more short of breath... Read more
Feeling tachycardia daily since date of injection of COVID19 vaccine, sometimes more short of breath when going up stairs.
72 2021-03-09 loss of consciousness, pulmonary embolism, fainting Patient received dose #2 of moderna vaccine on 3/2/2021. The next morning (3/3/21) she had a syncopa... Read more
Patient received dose #2 of moderna vaccine on 3/2/2021. The next morning (3/3/21) she had a syncopal event with LOC for several minutes. She recovered and was not evaluated by physician until 3/9/21. On 3/10/21, she had a CTA of chest showing bilateral PEs.
72 2021-03-09 loss of consciousness Patient reported losing consciousness in the evening after the shot and being admitted to the hospit... Read more
Patient reported losing consciousness in the evening after the shot and being admitted to the hospital.
72 2021-03-10 blood pressure increased, palpitations 3 minutes after the vaccine was administered I had a Complement Immune System Pathway reaction. I h... Read more
3 minutes after the vaccine was administered I had a Complement Immune System Pathway reaction. I have been dizzy every since. I have had intestinal issue. the next day I almost fainted and my heart was racing. I went to the ER with palpitations dizziness and elevated blood pressure. EKG (dr said it was normal but I retrieved the report which says inferior infarction and abnormal ECG) and blood pressure(138/83) readings taken.
72 2021-03-10 chest pain After I received my first dose Moderna vaccine, I was concerned about having a virus because I was n... Read more
After I received my first dose Moderna vaccine, I was concerned about having a virus because I was not feeling well. I had pain in chest, sore throat, ear aches and felt very tired.
72 2021-03-10 heart rate increased Patient was monitored and at 30 minutes, patient stated feeling itchy with slight rash/redness devel... Read more
Patient was monitored and at 30 minutes, patient stated feeling itchy with slight rash/redness developing on neck/chest area. Patient stated feeling increased heartrate, however heart rate and sp02 were check twice and at normal levels. Administration of benadryl 50 mg was given. Patient did not have any signs of anaphylaxis , after 1 hour patient still had itchy feeling/rash but no other issues. Patient was recommended to seek medical attention. Contacted later and patient was doing ok with no other symptoms besides tiredness/fatigue from vaccine.
72 2021-03-12 heart rate increased Pain, tenderness and swelling at injection site. Fatigue, headache, muscle pain, joint pain, chills,... Read more
Pain, tenderness and swelling at injection site. Fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, dizziness, weakness, fast heartbeat
72 2021-03-12 heart rate increased Rapid heartbeat, fever, muscle aches, headache, soreness at injection site
72 2021-03-13 heart rate increased 12 hours post 2nd moderna vaccine, 102 fever, bad joint, muscle pain and bad neck and headache, ext... Read more
12 hours post 2nd moderna vaccine, 102 fever, bad joint, muscle pain and bad neck and headache, extreme nausea, fatigue, fast heart beat, had to stay in bed for 2 days. Three days post vaccine started the symptoms of extreme fatigue, nausea, dizziness and some vomiting of crackers and water, some diarrhea which is still occurring presently. Have some energy after 6pm, can eat rice but still extreme nausea, fatigue, fast heartbeat.
72 2021-03-13 heart rate increased Approximately 20 minutes after receiving the vaccine I began to experience facial prickling and ting... Read more
Approximately 20 minutes after receiving the vaccine I began to experience facial prickling and tingling. A moment or two later I began to experience extremely rapid heartbeat. The rapid heartbeat began to subside after I received medical attention but took several hours to subside completely. The facial prickling sensation took at least 6 hours to subside. I also had the arm pain that I know is common, and that took 48 hours to subside.
72 2021-03-13 fainting Severe arm pain, fever, achy joints, muscle aches, headache, upper back muscle weakness, faintness... Read more
Severe arm pain, fever, achy joints, muscle aches, headache, upper back muscle weakness, faintness. Lasted for 30 hours.
72 2021-03-14 blood pressure increased as soon as the pt got the vax her face turned red, forehead and ears were hot. Her BP spiked. She ... Read more
as soon as the pt got the vax her face turned red, forehead and ears were hot. Her BP spiked. She stayed until her face cooled down. Did not get a BP Reading. The next day her right arm was very sore and hard around the injection site. A week later she developed a 3 1/2 x 4 red, itchy rash on her right arm. She contacted her PCP and was told to take Benadryl and cortisone. The redness lasted about 3 days but is now gone but is still itchy.
72 2021-03-14 heart attack Patient expired on 02/26/2021 from a Myocardial Infarction
72 2021-03-14 platelet count decreased 2/25/21 @ 8:00 pm had fever, chills, vomited. Over those symptoms by 9:00 am next day. Did notice ... Read more
2/25/21 @ 8:00 pm had fever, chills, vomited. Over those symptoms by 9:00 am next day. Did notice red spots on my face. On 2/27 noticed red spots on legs from knee down. 3/4/21 had appointment with my dermatologist and she sent me to have blood work. Blood work showed my platelets were down to 33. Went to hematologist same day and was put on dexamethasone 4mg . 10 pills a day for 4 days. Had blood work done 3/8/21, platelets 186. Stopped dexamethasone. Had blood work done 3/11/21, platelets now 300.
72 2021-03-14 pulmonary embolism Blood clot on right lung; soreness in arm; A spontaneous report was received from a 72 year old fem... Read more
Blood clot on right lung; soreness in arm; A spontaneous report was received from a 72 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced blood clot on right lung (pulmonary embolism) and myalgia. The patient's medical history was not provided. The patient had family history of blood clot (mother and brother). No concomitant product use was reported. On 02-Feb-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. The patient had soreness in the right arm which subsided couple of days later. The patient also experienced shortness of breath for a week after vaccine administration. On 17-Feb-2021, the patient went to the hospital and underwent COVID-19 virus test, the results of which were negative. On 17-Feb-2021, the computerized tomography scan on chest showed moderate size blood clot on right lung. On 18-Feb-2021, the patient was discharged from the hospital on recommendation to initiate and continue lifetime treatment with Eliquis (apixaban, 5mg every 12 hours). According to the physician, moderate size blood clot on right lung of the patient could be attributed to the genetic history (patient's mother and brother also had blood clot). The patient also followed up with primary care physician, who informed that it was genetic and not related to vaccine. Action taken with mRNA-1273 was not reported. The outcome of the events, pulmonary embolism was unknown. The outcome of the event, myalgia was considered as recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
72 2021-03-16 nosebleed, haemoglobin decreased, platelet count decreased Developed epistaxis on 3/11 after second dose of vaccine on 2/25 (1st dose 1/28). On 3/12 noted pet... Read more
Developed epistaxis on 3/11 after second dose of vaccine on 2/25 (1st dose 1/28). On 3/12 noted petechiae then on 3/13 awoke with spontaneous periorbital hematoma. Evaluated on 3/16, platelets 8.
72 2021-03-16 fibrin d dimer increased Presents to ED ~9 days after covid vaccine. Next day had fever, cough, muscle aches, diarrhea. Sympt... Read more
Presents to ED ~9 days after covid vaccine. Next day had fever, cough, muscle aches, diarrhea. Symptoms have persisted. Admitted for respiratory failure and possible pneumonia. D-dimer elevated, covid test negative, CTA chest negative for PE. D/C'd home after 1 week.
72 2021-03-17 excessive bleeding, loss of consciousness Patient reports feeling symptoms later the same evening the day of receiving her 2nd dose of Moderna... Read more
Patient reports feeling symptoms later the same evening the day of receiving her 2nd dose of Moderna. Her twin sister, also reported similar symptoms after receiving her 2nd dose of Moderna the same day (3/5/21). Patient reported feeling nausea and having "extreme" chills that evening. The next morning at 8 a.m. Patient called her sister, at 8 a.m. When she arrived at her sister's house she found patient unresponsive. She was taken to the hospital and remained there for 5 hours. Patient reports passing out, losing control of her bodily functions and hitting her head on a heavy resin figure. "Blood was all over the place." She reports that 2 spots on her scalp were bleeding and subsequently treated at the hospital. Patient currently is still experiencing extreme fatigue following the vaccination.
72 2021-03-17 loss of consciousness Blackout and Had to go to Bed; Red From Shoulder to elbow; Intense itching From Shoulder to elbow; M... Read more
Blackout and Had to go to Bed; Red From Shoulder to elbow; Intense itching From Shoulder to elbow; Mild Chills; Hard to the Touch; Swollen Injection Site.; Injection Site was Very Red (Golf Ball Size); Intense Itching 2-4" across on injection site; Muscle pain; A spontaneous report was received from a consumer concerning a 72-year-old female patients, who received Moderna's Covid 19 vaccine(mRNA1273) experienced muscle pain, itching across on injection site, injection site was very red (golf ball size), hard to the touch and swollen injection site, mild chills, started blackout, itching and redness from shoulder to elbow. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 17 Feb 2021, prior to the onset of the symptom, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Feb 2021, approximately 2 hours prior to the onset of symptoms, the patient received second of two planned doses of mRNA-1273 (Batch Number: 41L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced muscle pain. On 19 Feb 2021, after two hours of vaccination, the patient experienced intense itching 2-4" across on injection site. Eight hours post second shot patient's injection site was very red (Golf Ball Size), hard to the touch and swollen. 25 hours after the injection patient developed mild chills followed by blackout and had to go bed, intense itching and redness from shoulder to elbow. Treatment for the event included Hydrocortisone cream. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events mild chills, started blackout, intense itching and was reported recovering. The outcome of the events itching across on injection site, injection site was very red (golf ball size), hard to the touch and swollen injection site was reported recovered. The outcome of the events muscle pain, itching and redness from shoulder to elbow was not reported.; Reporter's Comments: Based on the information provided which includes a strong temporal association, and the known safety profile of the mRNA-1273 vaccine, a causal association between the reported events and the administration of vaccine cannot be excluded.
72 2021-03-18 blood pressure increased while patient was waiting the 15 minutes post vaccine in the waiting area she reported feeling tingl... Read more
while patient was waiting the 15 minutes post vaccine in the waiting area she reported feeling tingling in her tongue. she described the feeling as if "brushing her tongue with a very sharp toothpaste". told the patient that we will keep her for an additional 15 minutes to make sure it doesn't get worse or if it gets better. After 30 minutes the patient reported no change. Gave the patient 10ml (25mg) of liquid benadryl ( 12.5mg/5ml sus) which she said she will not take just yet but wait a little longer. took patients blood pressure which was high 160/100 (patient has history of BP) told the patient to wait inside the counseling room where I can keep a direct eye on but will check her BP again in 15 mins. after 15 mins the patients blood pressure was 140/85. she stated that her tongue was feeling a little better but the sensation wasn't completely gone. she said that she feels comfortable leaving and that she will take the benadryl if she felt worse. Tried calling the patient at 6:30pm but patient didn't answer.
72 2021-03-18 blood pressure increased TONGUE ITCHING, ELEVATED BLOOD PRESSURE, AND HEADACHE.
72 2021-03-18 chest pain, chest discomfort Pain and tightness across the chest and back in pain down the left arm. Called EMS and they transpor... Read more
Pain and tightness across the chest and back in pain down the left arm. Called EMS and they transported me to the hospital at midnight 35 2021 upon being put admitted into the hospital my liver enzymes and pancreas enzymes were elevated over 1000
72 2021-03-18 low blood oxigenation, cardiac arrest Patient called EMS from for respiratory distress. EMS arrived, noted severe distress and hypoxia. Pa... Read more
Patient called EMS from for respiratory distress. EMS arrived, noted severe distress and hypoxia. Patient transported to Hospital Emergency Dept. Patient deteriorated to respiratory arrest and cardiac arrest. Per ED note, after 30 minutes of aggressive resuscitation (including approximately 19 minutes in the ED), no ROSC was achieved. Patient expired
72 2021-03-18 loss of consciousness hair was coming out, lost all of her hair, bald; sore arm; passed out; tingling in face and hands; h... Read more
hair was coming out, lost all of her hair, bald; sore arm; passed out; tingling in face and hands; head was burning; A spontaneous report was received from a consumer concerning a 72-year-old ,female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events passed out(loss of consciousness), tingling in face and hands (paraesthesia), head was burning (burning sensation), hair was coming out, lost all of her hair(alopecia), and sore arm(pain in extremity). The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly for prophylaxis of COVID-19 infection. On 12 Feb 2021,immediately after the vaccination, the patient passed out, and when she woke up she had tingling on her face and hands, a sore arm, and head was burning. On 13 Feb 2021, the patient's hair was coming out and by 19 Feb 2021, she had lost all of her hair. She was bald by the end of the week. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, loss of consciousness, paraesthesia, burning sensation, alopecia and pain in extremity were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
72 2021-03-19 chest pain My arm hurt but eight hours later I ran a 100.3 fever. My spines was in terrible pain. My chest hurt... Read more
My arm hurt but eight hours later I ran a 100.3 fever. My spines was in terrible pain. My chest hurt, I could only take shallow breaths. I had chills for seven hours and a terrible head ache.
72 2021-03-19 loss of consciousness vomiting ,diarrhea, headache, muscle weakness, chills, fever, loss of conscious, fatigue. Loss of co... Read more
vomiting ,diarrhea, headache, muscle weakness, chills, fever, loss of conscious, fatigue. Loss of conscious resulted in hitting my as I hit the floor. Sustained a sore spot and bruise. More severe effects lasted for about 24 hrs, fatigue about 1 week or so.
72 2021-03-20 blood glucose increased Patient is diabetic and her glucose reading has spiked tremendously since taking the shot, even had ... Read more
Patient is diabetic and her glucose reading has spiked tremendously since taking the shot, even had a reading of 400, 276, 256. Every time patient eat something her glucose reading is very high. This was not happening prior to her being vaccinated. A1C was 6.8
72 2021-03-20 chest pain Pain in left arm site of injection that moved across upper ribs and moved to shoulder blades and up... Read more
Pain in left arm site of injection that moved across upper ribs and moved to shoulder blades and upper chest. Pain is burning numbness above and below heart and into lungs. Neck pain and numbness on left side of head and chest region. Chills , nausea and diarrhea. Cough.
72 2021-03-20 deep vein blood clot Feeling terrible; Feeling tired; Bloot clot in knee; A spontaneous report was received from a nurse ... Read more
Feeling terrible; Feeling tired; Bloot clot in knee; A spontaneous report was received from a nurse who was a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a blood clot in her knee, feeling terrible and feeling tired.. The patient's medical history was not provided by the reporter. No relevant concomitant medications were reported. On 25 Feb 2021, the patient received her second of two planned doses of mRNA-1273 (Lot number: 031M20A) intramuscularly for prophylaxis of COVID-19 infection. On 04 Mar 2021, a week after vaccination, the patient was seen at the hospital and was diagnosed with a blood clot in her knee of unknown origin. She also reported that she has continued feeling terrible and feeling tired. Lab details were not provided by the reporter. Treatment for the events were unknown. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, blood clot in her knee, feeling terrible and feeling tired, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
72 2021-03-21 transient ischaemic attack pt states that a couple of weeks after taking the vax she ended up in the Hospital ER on 3/18/2021 f... Read more
pt states that a couple of weeks after taking the vax she ended up in the Hospital ER on 3/18/2021 for symptoms of having a stroke and blurred vision. On 3/18/2021 Pt was transferred to Hospital in. They ran ECHO, EKG, CT and MRI. Blood Work. No findings of clogged arteries. DX was w/ TIA possible cause due to AFIB. Pt states that she no longer has any symptoms.
72 2021-03-22 blood pressure increased, heart rate irregular Increase in blood pressure, irregular heart beat, confusion, light headedness, upset stomach, lethar... Read more
Increase in blood pressure, irregular heart beat, confusion, light headedness, upset stomach, lethargy, dizziness
72 2021-03-22 blood pressure increased Patient started to cough after vaccine, felt it was her asthma. EMT on site took vitals 14:08 - BP 1... Read more
Patient started to cough after vaccine, felt it was her asthma. EMT on site took vitals 14:08 - BP 190/120, HR 118, R 20, labored and wheezing. Patient denies allergies but has long standing asthma and hasn't taken her medication today. RN advised patient to take Albuterol - patient took 3 puffs with immediate relief. Vitals at 14:20 - BP 202/120, O2 97, HR 102. Ambulance called at 14:25 d/t increased BP and visible anxiety sx from patient, crying and coughing. 14:31 Ambulance assessed patient found BP lowered to 162/92, HR 108. Patient refused transport, will follow up with PMD or 911 prn worsening. Patient walked out of vaccination waiting area on her own and obtained a ride with Lyft.
72 2021-03-22 heart attack, chest pain Heart attack; Fatigue; Chest Pain; Cough; Fever; Muscle pain in chest area; Chills; A spontaneous re... Read more
Heart attack; Fatigue; Chest Pain; Cough; Fever; Muscle pain in chest area; Chills; A spontaneous report was received from a 72 year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed heart attack (myocardial infarction), fever (pyrexia), cough, fatigue, muscle pain in chest area (myalgia), chills, and chest pain. The patient's medical history and concomitant medications were not reported. On 25-JAN-2021, 26 hours prior to the onset of events, the patient received her second of two planned doses of mRNA-1273 (lot#: unknown) intramuscularly for the prophylaxis of COVID-19 infection. On 26-JAN-2021, the patient reported they have developed chills, fever, and muscle pain in the chest area. The reporter specified that it wasn't chest pain. The patient took acetaminophen for the pain. On 27-JAN-2021, the patient reported her fever subsided but she was still having a little cough and chest pain. On 28-JAN-2021, the patient had chest pain again during a nap and decided to call 911 because she was about to pass out. The patient was taken to the ER (emergency room) where an EKG (electrocardiogram) was performed. A few moments after the EKG, the patient had a heart attack. The cardiologist suspected the patient may have had a heart attack two days earlier because her cardiac enzymes were too high to be a result of a recent heart attack. The patient was admitted to the hospital from 28-JAN-2021 until 01-FEB-2021. Catheterization and stent placement were performed. Treatment medications included acetaminophen, clopidogrel, metoprolol, low-dose aspirin, and atorvastatin. At the time of this report, the patient was still feeling fatigued but other than that, she was feeling better. Action taken with mRNA-1273 in response to the events was not applicable. The outcomes of the events, heart attack, cough, muscle pain in chest area, fever, chills, and chest pain, were resolved. The outcome of the event, fatigue, was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
72 2021-03-23 deep vein blood clot Deep Vein Thrombosis in both legs; eye was completely black/veins in the back of eye are completely ... Read more
Deep Vein Thrombosis in both legs; eye was completely black/veins in the back of eye are completely black; eyes started to go very blurry; scared to sleep at night, scared to move/afraid to live life, petrified with this; arm is sore and puffed up; arm is sore and puffed up; A spontaneous report was received from a consumer, concerning a 72-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed deep vein thrombosis (DVT) in both legs/deep vein thrombosis, one clot from groin to mid chest and one behind knee to groin, quite large and very risky, extremely large thrombus, scared to sleep at night, scared to move, afraid to live life, petrified with this/ fear, eyes started to go very blurry/ vision blurred, left eye was completely black and veins in the back of eye are completely black/ eye contusion and arm was sore/ pain in extremity and puffed up/ peripheral swelling. The patient's medical history included being a cancer survivor twice. No relevant concomitant medications were reported. On 26 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 014M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 09 Mar 2021, approximately ten days after receiving vaccine, the patient's eyes started to go very blurry, her left eye was completely black and veins in the back of eye were completely black. On 10 Mar 2021, she had one clot from groin to mid chest and one behind knee to groin, quite large and very risky, extremely large. She was afraid to live her life and was petrified. She developed a DVT in both legs and was taken to the emergency room. She was hospitalized on 10 Mar 2021and had positron emission tomography (PET) scan, doppler, echocardiogram with pictures of face and neck. Her lung was dyed, she had 3 types of dye, had PET scan for brain, chest, blood draws from finger and shots of blood thinner in stomach. She was scared to sleep at night and scared to move. Her arm was sore and puffed up. On 13 Mar 2021, she was discharged from the hospital. Treatment of the events included Eliquis. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, deep vein thrombosis, fear, vision blurred, eye contusion, pain in extremity and peripheral swelling were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
72 2021-03-23 heart rate increased Shortness of breath, lightheaded, feeling of throat closing (able to communicate with no drop in spo... Read more
Shortness of breath, lightheaded, feeling of throat closing (able to communicate with no drop in spo2), unsteady on feet, elevated heart rate (90-115)
72 2021-03-23 hypertension breathing problem; high blood pressure; severe headaches; A spontaneous report was received from a ... Read more
breathing problem; high blood pressure; severe headaches; A spontaneous report was received from a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events breathing problem, high blood pressure and severe headaches. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03-Feb-2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 010M-A (unknown numbers between M and A)) intramuscularly for prophylaxis of COVID-19 infection. On 10-MAR-2021, 1 month 7 days after receiving the vaccine, the patient reported a breathing problem which lasted for two weeks. The patient also experienced high blood pressure and severe headaches. The patient's physician contraindicated the patient to have the second dose. No treatment information was provided. The seriousness criteria for the event breathing problem was considered as medically significant. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, breathing problem was recovered/ resolved and the action taken for high blood pressure, severe headaches was unknown.; Reporter's Comments: Based on the current available information and lack of clear temporal association between the use of the product and the start date of the events, a causal relationship was assessed as unlikely related.
72 2021-03-23 loss of consciousness Awoke early morning with headache; felt dizzy. Went downstairs for Tylenol; on return to bed felt n... Read more
Awoke early morning with headache; felt dizzy. Went downstairs for Tylenol; on return to bed felt nauseated, sweaty, dizzy. Passed out on bed for approximately 15 seconds. Husband shook me and called out then I awoke and gained consciousness. Rested in recovery the remainder of the day and was able to take the Tylenol and resume normal activity by midday.
72 2021-03-23 fast heart rate, blood pressure increased Severe headache, blood pressure approx. 200/150, fast heart rate - 118, temperature of 103.4, deliri... Read more
Severe headache, blood pressure approx. 200/150, fast heart rate - 118, temperature of 103.4, delirium
72 2021-03-24 low blood platelet count, platelet count decreased rare condition Immune Thrombocytopenia (ITT); platelets decreased; A spontaneous report was receive... Read more
rare condition Immune Thrombocytopenia (ITT); platelets decreased; A spontaneous report was received from a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced low platelets and rare condition Immune Thrombocytopenia (ITT). The patient's medical history was not provided. No relevant concomitant medications were reported. On 25-FEB-2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly on left upper arm for prophylaxis of COVID-19 infection. On an unspecified date, in the same week after receiving the vaccine, the patient had been for a dermatologist appointment and her blood work showed low level of platelets. On an unspecified date, the patient went to hematologist and was diagnosed with rare condition Immune Thrombocytopenia (ITT) which caused patient bruises and red spots on mostly knee down. The patient was treated with steroid medication. The seriousness criteria for the events low platelets and rare condition Immune Thrombocytopenia (ITT) was considered as medically significant. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events low platelets and rare condition Immune Thrombocytopenia (ITT) was unknown. The reporter did not provide the assessment for the event, rare condition Immune Thrombocytopenia (ITT).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
72 2021-03-24 loss of consciousness Headache Trouble staying awake Fever Passed Out (once)
72 2021-03-25 atrial fibrillation, heart rate increased Atrial Fibrillation; Heart beating fast; A Spontaneous report was received from a consumer(patient) ... Read more
Atrial Fibrillation; Heart beating fast; A Spontaneous report was received from a consumer(patient) concerning herself a 72 year old female patient, who received dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart beating fast/heart rate increased, atrial fibrillation. The patient's medical history was not provided. Concomitant medications included metformin, gabapentin, metoprolol, thyroid medication, folic pills, frusemide. On 27 Feb 2021 prior to the onset of events the patients received first dose of the two planned doses of mRNA-1273 (Batch N0:039K20A) intramuscularly in the left arm for prophylaxis of covid 19 infection. On 28 Feb 2021, patient experienced heart beating fast, She ended up going to hospital where she was diagnosed for Atrial Fibrillation. She stayed in hospital for four days. She was discharged on 03 Mar 2021. The event caused hospitalization and was serious. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, increased heart rate and atrial fibrillation resolved on 03 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
72 2021-03-25 blood glucose increased, chest pain insomnia; chest pain; woozy feeling in head; knee and back pain; high blood sugar
72 2021-03-25 nosebleed 03/26/21 blood-tinged sputum expectorated around 5pm. Once event so far.
72 2021-03-25 heart rate irregular She got the vaccine, and they asked her to stay for the 15 minutes and she was fine, but when she we... Read more
She got the vaccine, and they asked her to stay for the 15 minutes and she was fine, but when she went out onto the street she started to have a few seconds of feeling faint but did not. That feeling passed and was able to walk home and was getting vertigo. She had a sore arm the next day, very fatigued and exhaustion. Three days later had redness appear on the arm and then had headaches, and insomnia that night. Her eyes were burning as well. A day later had irregular heart beat and then six days later had the red line, raised in a circle that lasted one day. She then continued to have the itching and then became a rash which was traveling under arm and onto her chest. She then went to the city UC and was spreading to her breast, and started to subside. Since then she has been having on and off headaches, on and off itching of both of her arms, as well as her scalp and other parts of her body. As a child had a history of hives. When she went to the UC they did an EKG due to the irregular heart beat and did not want to go to the ER during the pandemic. He gave her one Benadryl and 3 Ibuprofen which she only took one of, as she has a lot of allergies. She has been taking Zyrtec 5 mg for the itching when she has it, which works for her. The symptoms are subsiding, and has transient rashes on the vaccine arm, and on the right arm still have a few areas and still itching on and off.
72 2021-03-25 loss of consciousness New onset Seizure with acute loss of consciousness. L arm induration and swelling.
72 2021-03-27 fainting Patient experience syncopal episode around 7pm after receiving the COVID-19 vaccine at 11:22 am the ... Read more
Patient experience syncopal episode around 7pm after receiving the COVID-19 vaccine at 11:22 am the same day. Patient then experienced a second syncopal episode sometime through the night and EMS was call to bring patient to the ER. Patient reported headache, generalized weakness, and malaise. Patient was later admitted to the hospital for monitoring of vitals, neuro checks and anti-emetics.
72 2021-03-27 fast heart rate, heart flutter Swelling, hardness, pain and a red rash at injection site; lethargy; swollen lymph glands, especiall... Read more
Swelling, hardness, pain and a red rash at injection site; lethargy; swollen lymph glands, especially in the feet and redness and swelling of the feet; heart symptoms: an uncomfortable sensation with each heartbeat - it felt like the heart was having difficulty pumping the blood up. It took longer for the heart to suction up the blood before each heartbeat and I could feel a beat or a thud after each succioning up of the blood. The sequence felt like: slow suctioning, then a pounding; slow succioning followed by a pounding, etc. I also felt a frequent fluttering of the heart. The rash on the arm has turned to redness. The swelling and hardness are still there. The feet are still red and swollen and I can feel the enlarged, hard lymph glands. I'm still lethargic and sleep throughout the day. The heart problems only began to subside this afternoon. Because of the above symptoms (and other symptoms I cannot directly connect to the injection, but that occurred at the same time), I am afraid to get the second injection.
72 2021-03-28 deep vein blood clot Pt received Covid-19 Moderna vaccine dose #1 on 1/23/21. Dose #2 administered on 2/20/21 @ 12:43pm.... Read more
Pt received Covid-19 Moderna vaccine dose #1 on 1/23/21. Dose #2 administered on 2/20/21 @ 12:43pm. Pt presented to on 3/9/21 w/ complaints of localized edema x1-2 days in the left lower leg. (Symptoms started 3/7/21). Pt denied associated calf or extremity pain but reported she went shopping on Saturday and walked "alot." Pt reported she could walk on it but it "felt funny & tight" so she took an extra furosemide 40mg on 3/8/21. Trace edema in right ankle, 3+ pitting edema left leg from knee distally, slight increased warmth, no calf tenderness, negative Homan's sign, extremity asymmetric. Pt referred for venous doppler (unilateral, left leg, left leg edema, . Findings: acute, occlusive DVT in one of the duplicated left FV, the left popliteal vein, peroneal vein, & PTV. Superficial phlebitis and phlebothrombosis left GSV. per, FASC, RVPI 3/9/21 @ 2:27pm. Pt sent to ED for evaluation. Pt started on Xarelto in ED, changed to Eliquis per Dr. Eliquis 5mg PO BIDx7 days, then 5mg PO BID.
72 2021-03-28 heart rate increased Chills, Fever, Rapid Heart Rate, Nausea, very sore, tender arm.
72 2021-03-29 cerebrovascular accident Patient received dose 1 of Moderna vaccine on 3/2/2021. She returned for a second dose on 3/30/2021... Read more
Patient received dose 1 of Moderna vaccine on 3/2/2021. She returned for a second dose on 3/30/2021 and notified team she had a stroke 3 days after receiving the vaccine. Vaccine not given today. Patient admitted to another healthcare system for stroke.
72 2021-03-29 cerebrovascular accident Sustained a CVA (lacunar infarct)
72 2021-03-29 deep vein blood clot, pulmonary embolism developed extensive DVT of LLE and PE on approx 3/27 admitted to hospital on 3/29
72 2021-03-29 fainting, heart rate increased Date and time adverse event started: 3/26/21 0345 Patient had syncopal episode on toilet; has hx of ... Read more
Date and time adverse event started: 3/26/21 0345 Patient had syncopal episode on toilet; has hx of vasovagal syncope per husband; patient also developed headache on 3/28/21 7pm. Took tylenol with good relief What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): Spoke with Cardiologist re: syncopal episode and elevated HR at rest
72 2021-03-30 cerebrovascular accident pt was diagnosed with a stroke which affected her speech only. Pt was admitted to the hospital for 2... Read more
pt was diagnosed with a stroke which affected her speech only. Pt was admitted to the hospital for 24 hour observation and then discharged to home
72 2021-03-30 heart rate increased, hypotension, chest discomfort, oxygen saturation decreased Extreme chills with four degrees of fever with low blood pressure. My heart was beating very fast...... Read more
Extreme chills with four degrees of fever with low blood pressure. My heart was beating very fast...much faster than normal and my heart and lungs felt like they were in an oven cooking. Then I was feeling achy and my other insides felt warm and ackey. The tops of both of my arms became red like I had been in the sun which lasted for days. I was also short of breath. I told my son the next day that if he left, when he came back, I might be dead. I stayed in bed. My oxygen level we t down a bit. I finally took some aspirin and some Tylenol. Five days later I felt better but I feel like I will not get vaccines any longer after that and I may have had some sort of heart inflamation. I am sorry that I did the moderna vaccine. I will be telling my doctors a out this. We will be seeing if my body is damaged. The scariest part was the fast heart beat and it feeling hurtful and hot in my chest. You knew something was happening. I had also felt my heart squeezing on the tenth and eleventh day on the first shot.
72 2021-03-30 heart rate irregular Within a couple of minutes of the shot, I felt dizzy, weak and as if I were going to pass out. Wait... Read more
Within a couple of minutes of the shot, I felt dizzy, weak and as if I were going to pass out. Waiting a 5-10 minutes before asking for medical assistance. Nurse on site said she heard an irregular heartbeat, with blood pressure at 80/40. After drinking water and eating a couple of peanut butter crackers begin to feel a little better. Another check of heart rate it was normal and blood pressure was within normal range of 120/72. Resting a few more minutes and felt better. Came home and slept most of the day. Symptons had disappeared in an hour or so. I plan to follow up with my family doctor to see if anything else is going on medically with me.
72 2021-03-30 hypertension Patient is a 72 yo woman with PMH of TB, hyperparathyroidism, mitral regurg, HTN, diverticulosis s/p... Read more
Patient is a 72 yo woman with PMH of TB, hyperparathyroidism, mitral regurg, HTN, diverticulosis s/p partial colectomy, and multiple food allergies (seafood and nuts) as well as penicillin and contrast dye allergy who presents for COVID Moderna vaccine dose 2. Patient states that within 24 hours of her first dose, she developed body aches, fever to 102, as well as skin rash - had a raised rash on her arms and thighs on both sides of her body, but most prominent on her left thigh. She states the fever and body aches improved with tylenol but the rash persisted and she noted that on her chest and her legs and arms she had small areas that came and went over the next week. She took no medications for the rash, no anti-histamines and no creams, and found the rash resolved over time. She sees physician for allergy and immunology for her newly developed peanut allergy and she is in the process of establishing care with a new PCP. 1. I educated patient re: need to defer dose 2 of Moderna until she discusses her reaction with allergy and immunology provider 2. I educated that we can defer this dose safely until the location and management of her second dose is determined and that she will not need to restart her dosing schedule. 3. As she is established with allergy and immunology provider, will send message to her allergist, her PCP, and the healthcare facility front desk pool. 4. Allergy to COVID Moderna has been entered and can be edited as needed by allergy and immunology provider 3. Patient is very understanding of plan COVID-19 Vaccine Adverse Reaction Flowsheet Most Recent Value Did this reaction occur immediately following COVID-19 immunization while at the vaccine clinic? No Did the symptoms start prior to the vaccine dose? No What brand vaccine was administered? Moderna Which COVID-19 vaccine dose is being documented on? COVID-19 Vaccination Dose 1 Time of symptom onset: 24 What potential COVID-19 vaccine local injection site side effects are present? Injection site redness Duration of local side effects: > or equal to 7 days Which systemic symptoms that potentially could be a severe allergic reaction to COVID-19 vaccine are present? Body rash, Hives, Itchiness What side effects could potentially be due to the COVID-19 vaccine or due to COVID-19 illness are present? Body Aches (Muscle Pain/Joint Pain), Fever (> 100.0F) Temperature: 102 °F (38.9 °C) What possible symptoms of COVID-19 infection are present but not likely due to a COVID-19 vaccine are present? None present Additional symptoms suggestive of Vasovagal reaction: None present Are there any other symptoms of possible side effects not listed above? No COVID-19 Vaccine related side effect? Possible
72 2021-03-30 palpitations, heart rate increased Increased heart rate when she walks; Very dizzy; May have received 1.5 dose instead of 1 dose; Heart... Read more
Increased heart rate when she walks; Very dizzy; May have received 1.5 dose instead of 1 dose; Heart racing (110 BPM heart rate); A spontaneous report was received from a consumer concerning his wife, a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart racing/ Palpitations (110 beats per minute) on walking/ Heart rate increased, felt very dizzy/ Dizziness, might have received 1.5 dose instead of 1 dose of vaccine/ Accidental overdose. The patient's medical history was not provided. No concomitant product use was reported. On 15 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 024M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 15 Feb 2021, an unspecified duration after receiving the vaccine, the patient experienced heart racing (110 beats per minute) on walking and felt very dizzy. The patient reported normal heart rate while resting. It was known that the patient might have received 1.5 dose instead of 1 dose of vaccine. Treatment information was unknown. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event received 1.5 dose instead of 1 dose of vaccine was considered resolved on 15 Feb 2021. The outcome of the events, heart racing (110 beats per minute) on walking, felt very dizzy, may have received 1.5 dose instead of 1 dose of vaccine, was not reported.; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273, lot # 024M20A with associated AEs of heart racing and dizziness. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
72 2021-03-30 palpitations, heart rate irregular, hypertension Immediately after vaccination, I got heart palpitations. A minute or two later, I was quite dizzy. M... Read more
Immediately after vaccination, I got heart palpitations. A minute or two later, I was quite dizzy. My husband said my pulse was 100 and irregular. The tech gave me ice water and I waited 15 minutes. When I left the store, I was still dizzy. My face was flushed. After I had been home about 10-15 minutes and the dizziness had gone, I took my bp. The first reading was 134/90, with pulse 84. Three more readings later, it was down to 118/86, pulse 76. The diastolic was still high but much better. I have had heart palpitations in the past but not with dizziness. I have never been diagnosed with high bp and my bp has always been normal at home.
72 2021-03-30 palpitations Fever 103.5. Chills. Achy bones. Nausea. Diarrhea. Weakness conti... Read more
Fever 103.5. Chills. Achy bones. Nausea. Diarrhea. Weakness continues still 1 month. Heart palpitations
72 2021-03-30 fainting I got up from my sofa about 6 hours after the 2nd Moderna shot, and felt lightheaded. My husband was... Read more
I got up from my sofa about 6 hours after the 2nd Moderna shot, and felt lightheaded. My husband was concerned and walked with me up the stairs then started going back down. He heard a thud and I had collapsed on the floor and it took him a few seconds to wake me up. I don?t remember passing out, but do remember him calling my name. This event happened six times in a row, but I don?t remember it. He had to hold me upright to get into bed. He called clinic, and they wanted me to go to emergency, but I just wanted to sleep and did not go in until the next day. I went to hospital and they ran many tests, but everything seemed to be ok, so I went home and have been ok since. Because I was ok before the shot, I believe that I had a bad adverse reaction to the 2nd shot.
72 2021-03-31 atrial fibrillation fast heart beat; Chills; pain at injection site (left); fever; nausea; A spontaneous report was rece... Read more
fast heart beat; Chills; pain at injection site (left); fever; nausea; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain, fast heart beat (atrial fibrillation ), fever, nausea, chills and was hospitalized with a diagnosis with atrial fibrillation. The patient's medical history was not provided. Concomitant medications reported were Eliquis(apixaban) pill for drug use for unknown indication. On 04-FEB-2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) Intramuscularly for prophylaxis of COVID-19 infection. On 08-MAR-2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 003A21A) Intramuscularly for prophylaxis of COVID-19 infection. On 08-MAR-2021, the patient experienced pain at injection site (left), fast heart beat, fever, nausea. On 09-MAR-2021, the patient experienced chills, The patient was diagnosed with atrial fibrillation and the patient was hospitalized on 09-MAR-2021 and discharged on 10-MAR-2021. Treatment details not given but the patient was prescribed a Holter(14 days monitor). Action taken with mRNA-1273 in response to the events was not applicable The outcome of event(s), pain at injection site (left), fast heart beat, fever, nausea, chills, and atrial fibrillation was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. It is unclear if the patient had AFib before as she did not report prior medical history but is taking a medication usually prescribed for AFib. Further information has been requested.
72 2021-03-31 loss of consciousness, excessive bleeding A spontaneous report was received from a consumer, concerning a 72 year old female patient, who rece... Read more
A spontaneous report was received from a consumer, concerning a 72 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) where I passed out, hit my head and skull was bleeding, lost control of my body functions, sever chills, I could hardly move, threw up, extremely tired, don't feel good and totally incoherent. The patient's medical history was not provided by the reporter, concomitant medications are losartan, baby aspirin, pill for cholesterol included by the reporter. On 05 Feb 2021, the patient received the first planned doses of mRNA-1273 on right arm and Lot number reported for the first dose was (010M20A) for prophylaxis of COVID-19 vaccination. On 05 Mar 2021, the patient received the second planned doses of mRNA-1273 on left arm and Lot number reported for the first dose was (014M20A) for prophylaxis of COVID-19 vaccination. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of I passed out, hit my head and skull was bleeding and lost control of my body functions were resolved and other events like sever chills, I could hardly move, threw up, extremely tired, don't feel good and totally incoherent were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
72 2021-03-31 low platelet count thrombocytopenia; neutropenia; facial paralysis; Body felt flushed; body felt warm; reaction to her ... Read more
thrombocytopenia; neutropenia; facial paralysis; Body felt flushed; body felt warm; reaction to her myasthenia gravis symptoms; tremors; not been able to swallow the water; esophagus spazzing; acute exacerbation to her myasthenia gravis; couldn't eat for 7 days in hospital, needed feeding tube; symptoms of rheumatoid arthritis; A spontaneous report was received from consumer who is a 72-year-old, female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Flushing (Body felt flushed), Feeling hot (body felt warm) , Myasthenic syndrome (reaction to her myasthenia gravis symptoms), Oesophageal spasm (esophagus spazzing), feeding tube user (couldn't eat for 7 days in hospital, needed feeding tube), Condition aggravated (acute exacerbation to her myasthenia gravis) , Neutropenia (neutropenia) , Thrombocytopenia (thrombocytopenia), Rheumatoid arthritis (symptoms of rheumatoid arthritis), Facial paralysis (facial paralysis), Tremor (tremors), and Dysphagia (not been able to swallow the water) The patient's medical history included Myasthenia Gravis and breast cancer. No relevant laboratory tests were reported. Concomitant medications included: mestinon, pantoprazole, tamoxifene, methylprednisolone, clopidogrel, rosuvastatin, leflunomide, oxybutynin, actemra, vitamin B12, vitamin D3. On 04-MAR-2021, the patient received her first of two planned doses on her left non dominant deltoidof mRNA-1273 (lot/batch: 025A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 04-MAR-2021, patient had reaction to her Myasthenia Gravis symptoms as she started having facial paralysis and tremors and not been able to swallow the water due to her esophagus spazzing. She admitted to the hospital for 11 days and finally discharged on 15-MAR-2021. While in the hospital she could not eat for 7 days so she was placed on a feeding tube. Patient provided with the treatment: IV plasmapheresis, feeding tube put in, endoscopy, platelets and blood infusion, and medications to keep unspecified blood levels. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, flushing, feeling hot, Myasthenic Syndrome, esophageal spasm , feeding tube user, condition aggravated, neutropenia, thrombocytopenia, rheumatoid arthritis, facial paralysis, tremor, dysphagia was resolved on 15-MAR-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's advanced age along with underlying conditions may have been contributory for the occurrence of the events.
72 2021-04-01 blood pressure increased Immediately following the injection, within 5 minutes, feeling across the forehead of "tension" insi... Read more
Immediately following the injection, within 5 minutes, feeling across the forehead of "tension" inside my head. At 30 to 35 minutes following the shot, swelling of lips and area around the mouth. Swelling of the tongue. Tightness of jaw. 2 hours later swelling began to slowly subside. By evening swelling mostly gone. Some tightness in jaw remained.
72 2021-04-01 body temperature decreased Hypothermia; Cold sweats; No appetite; Some dizziness; Temperature 94.2; Dull headache; A spontaneou... Read more
Hypothermia; Cold sweats; No appetite; Some dizziness; Temperature 94.2; Dull headache; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypothermia, cold sweat, appetite lost/decreased appetite, dizziness, temperature body decreased/body temperature decreased and headache The patient's medical history was not provided by the reporter. No concomitant medications were reported. On 12 Feb 2021, about two weeks prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 015M20A) via unknown route in an unknown location for prophylaxis of COVID-19 infection. On 12 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: 015M20A) via unknown route in an unknown location for prophylaxis of COVID-19 infection. After two weeks on 26 Feb 2021, the patient developed hypothermia in the morning. Then patient experienced a drop in body temperature to 94.2 F. The patient had to change clothes frequently due to cold sweats. The patient also reported that she had headache, dizziness and no appetite. The treatment medication was reported as acetylsalicylic acid for headache. The event hypothermia was considered medically significant. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, hypothermia, dropping body temperature, cold sweats, headache, dizziness and no appetite were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
72 2021-04-01 palpitations Chills, fever, rash, heart racing for hours, headache, neck ache, joint ache
72 2021-04-01 fainting approximately 14 hours after second Moderna vaccine, developed severe shaking chills, low grade feve... Read more
approximately 14 hours after second Moderna vaccine, developed severe shaking chills, low grade fever, nausea and fainting
72 2021-04-02 chest pain, inflammation of the pericardium Pt presented to the ER on 3/22/21 c/o sudden chest pain and fever of 101.1. She was transferred to t... Read more
Pt presented to the ER on 3/22/21 c/o sudden chest pain and fever of 101.1. She was transferred to the hospital due to concern for possible acute MI. She was ultimately found to have idiopathic pericarditis after further work up and discharged home on colchicine 2 days later.
72 2021-04-02 loss of consciousness 12 hours after the second COVID vaccine was received I had chills for two hours and then started vom... Read more
12 hours after the second COVID vaccine was received I had chills for two hours and then started vomiting. Only took two Tylenol and water. We had to spend the night because my husband had his second shot the next day. We had a two hour drive home and almost home I started to feel nausea light headed very hot. I passed out in the car so my husband pulled over to assist me. After five or so minutes I decided I could make it home but started vomiting again. I had nothing to eat but did drink sips of Sprite. He wanted to take me to ER but I said no. Worse sickness I?ve had in 72 years
72 2021-04-03 nosebleed Next day - Dizzy feeling of faint Red rash covering full body and still lingers 4 days later Day 5 s... Read more
Next day - Dizzy feeling of faint Red rash covering full body and still lingers 4 days later Day 5 slight nose bleed Non of these have been serious enough to see a Doctor But rash is itchy and annoying
72 2021-04-04 cerebrovascular accident On 3/7/2021, the patient experienced a cerebrovascular accident, was hospitalized for acute care the... Read more
On 3/7/2021, the patient experienced a cerebrovascular accident, was hospitalized for acute care then rehabilitation until 4/1/2021. Patient has a previous history of CVA.
72 2021-04-04 transient ischaemic attack Patients husband said that she normally needs a walking stick to help her get around, but that two d... Read more
Patients husband said that she normally needs a walking stick to help her get around, but that two days after her second shot she could not get out of bed. She went to the ER, but they couldn't figure out what was going on and sent her home with APAP. She went back to the ER 5-4-2021 and she was diagnosed with a TIA.
72 2021-04-05 blood glucose increased Beginning at 4am on 4/2, glucose readings went extremely high, so high it wouldn't register. It fina... Read more
Beginning at 4am on 4/2, glucose readings went extremely high, so high it wouldn't register. It finally began coming down to normal on 4/5. Patient's sugar was under control prior. She was not ill prior to it either, nor did her diet alter.
72 2021-04-05 pulmonary embolism Shortness of breath, cough onset Sunday April 4th. DATE OF SERVICE: 04.06.2021 CT ANGIOGRAPHY, CH... Read more
Shortness of breath, cough onset Sunday April 4th. DATE OF SERVICE: 04.06.2021 CT ANGIOGRAPHY, CHEST (CPT=71275); PULMONARY EMBOLUS PROTOCOL; 3-D RECONSTRUCTION CLINICAL INDICATION: SOB (shortness of breath) COMPARISON STUDY: 10/9/2020 TECHNIQUE: Axial images of the chest were performed during dynamic contrast enhancement for the optimization of the opacification of the pulmonary arteries, following IV administration of 80 mL of Isovue 370. Three-dimensional reformation into the coronal plane was performed. Automated exposure control and ALARA manual techniques for patient specific dose reduction were followed while maintaining the necessary diagnostic image quality. ADVERSE REACTION: None FINDINGS: PULMONARY ARTERIES: There is a large filling defect within the right interlobar artery, extending into the lobar, segmental, and subsegmental branches of the right lower lobe. There is expansion of the right interlobar artery by this thrombus. Small filling defect is noted within the distal left main pulmonary artery, with some extension to the left upper lobe and left lower lobe lobar segments. HEART AND VASCULATURE: The heart is normal size. No pericardial effusion. There is no evidence of right heart strain. MEDIASTINUM AND HILA: There is no mediastinal or hilar lymphadenopathy. LUNGS AND AIRWAYS: Heterogeneous densities are seen in the right lower lobe, new since the prior exam. Scarring is noted in the superior segment of the right lower lobe as well as in the anterior left lower lobe.. PLEURA: Small right pleural effusion. CHEST WALL, LOWER NECK, AND AXILLA: Grossly unremarkable. UPPER ABDOMEN: Grossly unremarkable. OSSEOUS STRUCTURES: Degenerative changes are seen within the visualized spine. IMPRESSION 1. Bilateral PE, with extensive thrombus on the right and minimal thrombus on the left as detailed above. 2. Small right pleural effusion and heterogeneous right lower lobe consolidation, likely reflecting pulmonary infarction.
72 2021-04-06 heart attack After my vacine, I thought I was having a heart attack. I called 911 and they took me to the hospita... Read more
After my vacine, I thought I was having a heart attack. I called 911 and they took me to the hospital and I was treated as if I had had a heart attack. At the hospital they performed EKG's and stress test. The EKG was slightly off but the stress test was normal. I felt all my body flushed after the Moderna vaccine. my cardiologist I am now seeing and at the hospital I saw another Dr. I also stayed at the Hospital one day for monitoring.
72 2021-04-07 deep vein blood clot Patient developed redness and swelling to left arm after 2nd Pfizer COVID vaccine that has been pers... Read more
Patient developed redness and swelling to left arm after 2nd Pfizer COVID vaccine that has been persisting for the past 21 days. Patient has positive DVT in her left arm from ultrasound on 3/31/21. Patient has history of breast cancer with lymph node removal to the left side. No current breast cancer diagnosis and lymph node unable to drain in left arm.
72 2021-04-07 heart rate increased First 2 days achy arm, itchy then OK. On 2-9-2021 schedule to donate blood. Went in for regular ch... Read more
First 2 days achy arm, itchy then OK. On 2-9-2021 schedule to donate blood. Went in for regular check but pluse rate was 110. After 20 minutes, when it did not subside was turned away from donating. had bee a bit short of breath so after 2 more days went to provider. heart rate still high, B normal. Chest xray was ordered and report was hyper extended lungs, COPD. Having never somked in my life baffled. Had Pulmonary function was rated normal but noted lungs age of 82 year old.
72 2021-04-07 blood clot blood clot in left arm causing enormous swelling
72 2021-04-08 heart rate increased, blood pressure increased Patient reported to be dizzy and get a headache within minutes of vaccination. She said her head hu... Read more
Patient reported to be dizzy and get a headache within minutes of vaccination. She said her head hurt and felt pressure around her head. Patient become shaky, nauseous, and lightheaded. We gave patient some water and she seemed very dehydrated. She drank about 4-5 cups of water over the course of 45 minutes. Blood Pressure checked at 2:25pm was 173/88 mmHg with Heart Rate of 68bpm. Patient given Benadryl 50mg at 2:30pm to help with dizziness and nausea. Temperature checked at 2:33pm was 97.2 F. We kept patient seated and monitored symptoms for another 15 minutes when she started to feel better and did not need any extra treatment. Left pharmacy at about 3:00pm feeling better and recommended to seek treatment if symptoms come back or worsen.
72 2021-04-08 hypertension Headache, stiff neck, high blood pressure , joint pain
72 2021-04-10 fainting my mother collapsed in the kitchen she was rushed to hospital via ambulance she passed away, doctor ... Read more
my mother collapsed in the kitchen she was rushed to hospital via ambulance she passed away, doctor said her heart was having a hard time he said there was a blood cot by lung
72 2021-04-11 chest discomfort fever, muscle ache (even my teeth hurt), nausea (actually threw up in my mouth), dizziness, weakness... Read more
fever, muscle ache (even my teeth hurt), nausea (actually threw up in my mouth), dizziness, weakness, headache, shortness of breath, heaviness in chest, fatigue, pain lifting left arm. Extreme discomfort. Stayed in bed for 2 entire days. If this had been my first shot, I would not have gotten a second.
72 2021-04-11 palpitations Severe palpitations lasted about 1:30 hours after 27 hours of the shot. Called the GP and was told t... Read more
Severe palpitations lasted about 1:30 hours after 27 hours of the shot. Called the GP and was told to rest and relax. Had chills, fever and muscle aches later. Still having a mild fever everyday e joint pains on and off. Yesterday (4/11) had the same severe palpitations. Same time and same time course. Heart beats went over 140 both times. The palpitations stop for few seconds and starts over again. Just took homeopathic stress pills and back to normal after 1:40
72 2021-04-12 fainting Per EMS patient's husband reports she was using the push mower in the front yard and suddenly collap... Read more
Per EMS patient's husband reports she was using the push mower in the front yard and suddenly collapsed. EMS brought the patient in with active CPR in progress and the patient was pronounced deceased in the Emergency Department.
72 2021-04-13 blood glucose increased Patient presented to the ED with new hyperglycemia. Patient received regular insulin in the ED. Pati... Read more
Patient presented to the ED with new hyperglycemia. Patient received regular insulin in the ED. Patient was admitted to the hospital for further evaluation and treatment.
72 2021-04-13 blood pressure increased Pt states that she had dose 1 of Moderna on 3/18. About a week later pt noticed her BP became elevat... Read more
Pt states that she had dose 1 of Moderna on 3/18. About a week later pt noticed her BP became elevated, she had a bad h/a, she also experienced dizziness, lightheadedness and some intermittent confusion.
72 2021-04-13 nosebleed Patient has first vaccination with Moderna Lot 047A21A on 3/15/2021. Following vaccination, patient... Read more
Patient has first vaccination with Moderna Lot 047A21A on 3/15/2021. Following vaccination, patient had complaints of Headache, Nasal Congestion, and Body Aches. Patient also had a bloody nose. She did not take any medication for her symptoms but complained of symptoms lasting three days. Patient was encouraged to receive the second dose of the vaccination on 4/12 and to use Tylenol and Advil to minimize symptoms. Patient had similar symptoms as after the first vaccination. Patient did take Tylenol and Advil - severity remained about the same.
72 2021-04-14 pulmonary embolism, fibrin d dimer increased 2/25--4 days after second COVID vaccine patient visited ED for c/o SOA and dyspnea. Chest CT shows ... Read more
2/25--4 days after second COVID vaccine patient visited ED for c/o SOA and dyspnea. Chest CT shows "small sized pulmonary emboli in the right middle lobe branches", Venous doppler shows "venous thrombosis involving the right posterior tibial venous segment". Hospitalized for 2 days--discharged home.
72 2021-04-14 fainting debilitating weakness, zero strength, barely unable to walk, diarrhea, faint, dizzy, exhausted, swea... Read more
debilitating weakness, zero strength, barely unable to walk, diarrhea, faint, dizzy, exhausted, sweating, headache, fever, chills, knife-like arm pain - all lasting four days
72 2021-04-15 atrial fibrillation A fib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRI... Read more
A fib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (A fib) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 029A21A) for COVID-19 vaccination. The patient's past medical history included AFib (Takes Flecainide for Heart Rate control) since an unknown date and Cardioversion in 2019. Concomitant products included FLECAINIDE for AFib, LOSARTAN, ATORVASTATIN, FUROSEMIDE (LASIX [FUROSEMIDE]) and POTASSIUM for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ATRIAL FIBRILLATION (A fib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (A fib) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: unknown (Inconclusive) Results not provided. On an unknown date, Electrocardiogram: unknown (Inconclusive) Results not provided. Patient was taken to ER (Emergency Room) where an EKG and a chest X-RAY were done. The results of the EKG and chest X-ray were not provided. Patient reported that she takes Flecainide for Heart Rate control. No other treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. This case was linked to MOD21-072680 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. MOD21-072680:MOD-2021-072836 1st dose case
72 2021-04-15 platelet count decreased, deep vein blood clot On April 3, 2021 the patient received the first dose of the Moderna COVID vaccine. The patient's hus... Read more
On April 3, 2021 the patient received the first dose of the Moderna COVID vaccine. The patient's husband states that "crashed an hour and a half after she got the shot." He defines this "crash" as decreased blood sugar, decreased responsiveness, and the seizures. She presented to the Hospital for evaluation and was subsequently transferred to the Medical Center on April 4th for further workup. She was intubated on April 4th and subsequently self-extubated on April 8th. Nursing staff and documentation indicate that the patient has had no further seizures since her presentation to the medical center. On April 14th she was found to have an acute lower extremity DVT. She was placed on a heparin drip and her platelet's dropped to 35. The heparin drip was discontinued, a HIT panel was ordered, and argatroban was started. Heamtology was consulted and the patient was found to have thrombotic thrombocytopenia. An MRI of the brain was ordered to rule out CNS thrombosis given recent seizures. The MRI has not been performed yet and the patient is still hospitalized.
72 2021-04-16 cerebrovascular accident Patient apparently suffered a minor stroke early morning of 4/11/2021. Patient had headache, leg pai... Read more
Patient apparently suffered a minor stroke early morning of 4/11/2021. Patient had headache, leg pain, and left leg weakness (described 'left leg giving out').
72 2021-04-16 blood clot Noticed painful right calf 3/09/2021. Went to urgent care at hospital on 3/10/2021. Was given an u... Read more
Noticed painful right calf 3/09/2021. Went to urgent care at hospital on 3/10/2021. Was given an ultrasound and it was determined that I had a blood clot in my calf vein. Was given heparin treatment for seven days followed by xarelto. I have had 2 dvts in the past associated with surgery. This dvt was listed as unprovoked, however I believe it was caused by the second shot of modern. Was told by doctors to report this to veers.
72 2021-04-18 chest discomfort Felt out of sorts when I went to bed...by Saturday morning had a fever of 102.2, headache, weakness,... Read more
Felt out of sorts when I went to bed...by Saturday morning had a fever of 102.2, headache, weakness, bodyaches, odd feeling in my lungs, loss of appetite, and diarrhea....bedridden for 36 hours. Also have very sore upper left arm. Sunday evening the fever was gone still very weak. Monday I still have very tender, swollen, and red upper left arm and walking more than 20 feet I am short of breath (just like I had in February and March after having Covid.)
72 2021-04-18 chest pain, pulmonary embolism Developed SOB and chest pain the evening of 4/6. Seen in my office on 4/7 and I ordered a chest CTA ... Read more
Developed SOB and chest pain the evening of 4/6. Seen in my office on 4/7 and I ordered a chest CTA which identified multiple PE's. She was hospitalized and started on Xarelto.
72 2021-04-18 fainting near syncope and went to ER.
72 2021-04-19 chest discomfort Within less than 30 minutes developed tightness in chest; within few minutes developed tremors - vio... Read more
Within less than 30 minutes developed tightness in chest; within few minutes developed tremors - violent at times. Also nausea with dry heaves. BP 162/94. Given 50 mg Benadryl IM IV started. Given Zophran IV
72 2021-04-19 hypertension Around 12:20 pm, client felt dizzy and nauseous. We gave her water and goldfish. Her blood pressure ... Read more
Around 12:20 pm, client felt dizzy and nauseous. We gave her water and goldfish. Her blood pressure was 132/82 at 12:28 pm. She felt better after the water and goldfish and left at 12:35 pm.
72 2021-04-20 pulmonary embolism Pulmonary Embolism/pneumonia
72 2021-04-21 cerebrovascular accident stroke
72 2021-04-22 cardiac failure congestive shortness of breath; congestive heart failure; H-pyloria infections in the stomach; fluid around the... Read more
shortness of breath; congestive heart failure; H-pyloria infections in the stomach; fluid around the lungs virus; Missed the second dose due to hospitalization; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath), CARDIAC FAILURE CONGESTIVE (congestive heart failure), HELICOBACTER GASTRITIS (H-pyloria infections in the stomach) and PLEURAL EFFUSION (fluid around the lungs virus) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported adverse event). On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), CARDIAC FAILURE CONGESTIVE (congestive heart failure) (seriousness criterion hospitalization), HELICOBACTER GASTRITIS (H-pyloria infections in the stomach) (seriousness criteria hospitalization and medically significant), PLEURAL EFFUSION (fluid around the lungs virus) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (Missed the second dose due to hospitalization). The patient was hospitalized from 13-Mar-2021 to 26-Mar-2021 due to CARDIAC FAILURE CONGESTIVE, DYSPNOEA, HELICOBACTER GASTRITIS and PLEURAL EFFUSION. At the time of the report, DYSPNOEA (shortness of breath), CARDIAC FAILURE CONGESTIVE (congestive heart failure), HELICOBACTER GASTRITIS (H-pyloria infections in the stomach), PLEURAL EFFUSION (fluid around the lungs virus) and INCOMPLETE COURSE OF VACCINATION (Missed the second dose due to hospitalization) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient missed the second dose due to hospitalization. Concomitant and treatment information not provided. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
72 2021-04-23 cerebrovascular accident Pt previously healthy other than controlled HTN received her 2nd moderna vaccine on 4/15- hospitaliz... Read more
Pt previously healthy other than controlled HTN received her 2nd moderna vaccine on 4/15- hospitalized on 4/18 (sxs starting 4/17) with a large L thalamic cryptogenic CVA/ sepsis/acute bacteremia/encephalopathy/lactic acidosis. carotid dopplers neg for acute pathology, echo normal and neg bubble study. Pt now with short term memory impairement, flat affect, and amnesia surrounding events of admission and hospitalization. She is a Lifelong non smoker. No past hx of atrial fibrillation- no atrial fibrillation noted on tele. PT/OT/speech path seen. ldl 108- started on lipitor, started on aspirin. aic 6.0, Gram negative bacteremia/e coli in cx- unclear GI source. Possibly diverticular. MRCP showed nothing acute. Home with a few more days of augmentin per ID dc home with home health services 4/22
72 2021-04-23 chest pain Patient stated she had pain in left side of stomach, chest pain, trouble breathing, and chills. Pati... Read more
Patient stated she had pain in left side of stomach, chest pain, trouble breathing, and chills. Patient stated the symptoms started the morning after the vaccine and have gotten worse over 4 days. Patient received the vaccine 4/20/21 and reported to pharmacy on 4/24/21. Patient stated she took Tylenol for pain. Pharmacist on duty instructed patient to visit an urgent care since her symptoms have gotten worse.
72 2021-04-23 hypertension high blood pressure/ chills..called dr/ rested/ doubled high blood pressure med that day
72 2021-04-24 heart rate irregular scary muscle weakness. difficulty holding my urine. frequent episodes of irregular heartbeat that ca... Read more
scary muscle weakness. difficulty holding my urine. frequent episodes of irregular heartbeat that caused anxiety
72 2021-04-24 palpitations Very rapid heart beat and shortness of breath. Also I received my 1st dose on 3/10/21 and on 3/31/2... Read more
Very rapid heart beat and shortness of breath. Also I received my 1st dose on 3/10/21 and on 3/31/21 I noticed blood in the toilet when I had a bowel movement. I received my 2nd dose on 4/7/21 and on 4/17/21 and I noticed blood in the toilet again. I did not strain and my stomach was not hard.
72 2021-04-25 fast heart rate Diaphoretic, tachycardia - observed by fire rescue for 30 minutes, returned to normal, cleared to go... Read more
Diaphoretic, tachycardia - observed by fire rescue for 30 minutes, returned to normal, cleared to go.
72 2021-04-26 low blood platelet count Idiopathic thrombocytopenic purpura; This spontaneous case was reported by a consumer (subsequently ... Read more
Idiopathic thrombocytopenic purpura; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 19-Jan-2021 due to IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. One day after the patient's first dose, the patient woke up with bruises on the arms and legs, and had blisters that bled inside mouth. The patient was admitted to an unspecified hospital on 19Jan2021 with a severe case of idiopathic thrombocytopenic purpura. Concomitant and treatment information not provided Company comment:Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
72 2021-04-26 ischaemic stroke My mother received the vaccine on 4/17/21. The following day she was bedridden. Her condition did ... Read more
My mother received the vaccine on 4/17/21. The following day she was bedridden. Her condition did not improve over the next two days. My wife and I were out of town and I was maintaining phone contact with her every few hours to monitor how she was feeling. She expected she would feel bad for a few days... On 4/21/21 she appeared to feel better in the morning when we spoke and she advised me she was going shopping with a friend. Around 2pm on 4/21/21 I received a phone call from her friend advising she was taking my mother to the emergency room at the local hospital. My mother was unable to answer basic questions and we believed she was suffering from a stroke. The following day when I arrived back in the area I spoke to the neurologist on call who confirmed my mother did have a minor stroke but that it was in an area of her brain that should not effect cognitive functioning. My mother was given a CT scan, brain MRI, spinal tap and an echocardiogram. All of these tests came back "normal". My mother is still in the hospital and has shown no improvement. She is agitated and confused. She asks the same questions over and over again. The neurologist has advised that they have no explanation as to why she is experiencing these symptoms. The only thing that changed was her receiving the covid vaccine.
72 2021-04-27 low blood oxigenation Patient presented to the ED and was subsequently hospitalized for shortness of breath within a week ... Read more
Patient presented to the ED and was subsequently hospitalized for shortness of breath within a week of receiving COVID vaccination. She was diagnosed with acute on chronic respiratory failure with hypoxia.
72 2021-04-28 pulmonary embolism Patient had Moderna #1 COVID-19 vaccine this morning in office. Due to history of anaphylaxis to PCN... Read more
Patient had Moderna #1 COVID-19 vaccine this morning in office. Due to history of anaphylaxis to PCN she waited for 30 minutes following injection. Near the 30 minute mark she reported having generalized itching, more pronounced in palms of hand and left ear. She denied lightheadedness, tongue itching/swelling, SOB, N/V/D, abdominal pain. No prior reaction to vaccinations in the past. She was evaluated by myself and was in no acute distress. She had swelling and itching of left external ear and redness and itching to her palms. No rash was noted. Lungs CTA. Patient was monitored in office for 30 minutes following reaction. She was given 50mg Benadryl po and 20mg Pepcid po. Ice pack applied to left ear for itching and swelling. Vitals remained stable throughout visit. Patient felt comfortable leaving, husband drove her. I spoke with her via phone four hours later and all symptoms had resolved other than fatigue. BP 140/70, Pulse 93, O2 99%, Temp 97.7F
72 2021-04-30 cardiac arrest had the cardiac arrest & was hospitalized for 12 days we still cannot find any reason for the cardia... Read more
had the cardiac arrest & was hospitalized for 12 days we still cannot find any reason for the cardiac arrest; was in extreme acidosis; somewhere along the line, I got sepsis; CT scan showed a hematoma in stomach; distended stomach; Still have terrible diarrhea; haven't gotten my second shot yet; following day, I started with extreme chills; Fever; was just miserable for several days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC ARREST (had the cardiac arrest & was hospitalized for 12 days we still cannot find any reason for the cardiac arrest), ACIDOSIS (was in extreme acidosis), SEPSIS (somewhere along the line, I got sepsis), HAEMATOMA (CT scan showed a hematoma in stomach), GASTRIC DILATATION (distended stomach) and DIARRHOEA (Still have terrible diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), ESTROGENS CONJUGATED (PREMARIN), VITAMIN D3, PROBIOTICS NOS and ALPRAZOLAM (XANAX) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIARRHOEA (Still have terrible diarrhea) (seriousness criterion hospitalization prolonged), FEELING ABNORMAL (was just miserable for several days), CHILLS (following day, I started with extreme chills) and PYREXIA (Fever). On 24-Mar-2021, the patient experienced CARDIAC ARREST (had the cardiac arrest & was hospitalized for 12 days we still cannot find any reason for the cardiac arrest) (seriousness criteria hospitalization prolonged, medically significant and life threatening), ACIDOSIS (was in extreme acidosis) (seriousness criteria hospitalization prolonged and life threatening), SEPSIS (somewhere along the line, I got sepsis) (seriousness criteria hospitalization prolonged and life threatening), HAEMATOMA (CT scan showed a hematoma in stomach) (seriousness criteria hospitalization prolonged and life threatening) and GASTRIC DILATATION (distended stomach) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (haven't gotten my second shot yet). The patient was hospitalized on 24-Mar-2021 due to ACIDOSIS, CARDIAC ARREST, DIARRHOEA, GASTRIC DILATATION, HAEMATOMA and SEPSIS. At the time of the report, CARDIAC ARREST (had the cardiac arrest & was hospitalized for 12 days we still cannot find any reason for the cardiac arrest), ACIDOSIS (was in extreme acidosis), SEPSIS (somewhere along the line, I got sepsis), HAEMATOMA (CT scan showed a hematoma in stomach), GASTRIC DILATATION (distended stomach), DIARRHOEA (Still have terrible diarrhea), FEELING ABNORMAL (was just miserable for several days), PRODUCT DOSE OMISSION ISSUE (haven't gotten my second shot yet), CHILLS (following day, I started with extreme chills) and PYREXIA (Fever) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Computerised tomogram: hematoma in stomach (abnormal) Four CT scans. Showed hematoma in stomach. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 24th March 21, Patient had multiple x-rays done. The result was not provided. Treatment for the events was not provided. CPR for 10 minutes which lead to have 4 broken ribs and one lung collapsed.; Sender's Comments: This case of 72 y/o who missed 2nd dose and experienced additional events. Based on the information provided, the events of sepsis, broken ribs and collapse lungs are assessed as unlikely as they occurred was secondary to the other events and intervention. Sepsis is of an infectious origin. Causality between product use and the remaining events cannot be excluded based on temporal association. Missed dose is not applicable and chills and pyrexia are consistent with product safety profile.
72 2021-04-30 heart attack, pulmonary embolism, blood clot blood clots in both legs; heart attack/blood clot in heart; Blood clots in lungs/shortness of breath... Read more
blood clots in both legs; heart attack/blood clot in heart; Blood clots in lungs/shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots in both legs), MYOCARDIAL INFARCTION (heart attack/blood clot in heart) and PULMONARY EMBOLISM (Blood clots in lungs/shortness of breath) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 8077727310 and 012LZ0A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced THROMBOSIS (blood clots in both legs) (seriousness criteria hospitalization prolonged and life threatening), MYOCARDIAL INFARCTION (heart attack/blood clot in heart) (seriousness criteria hospitalization prolonged and life threatening) and PULMONARY EMBOLISM (Blood clots in lungs/shortness of breath) (seriousness criteria hospitalization prolonged and life threatening). The patient was hospitalized on 09-Apr-2021 due to MYOCARDIAL INFARCTION, PULMONARY EMBOLISM and THROMBOSIS. At the time of the report, THROMBOSIS (blood clots in both legs), MYOCARDIAL INFARCTION (heart attack/blood clot in heart) and PULMONARY EMBOLISM (Blood clots in lungs/shortness of breath) outcome was unknown. No concomitant medications were reported. Treatment of the events included Xarelto and unspecified IV medications. Action taken with mRNA-1273 in response to the events was not applicable. Company Comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
72 2021-05-02 chest discomfort Approximately 2 1/2 weeks after second dose on 04/12, patient states she noticed a rash on her lower... Read more
Approximately 2 1/2 weeks after second dose on 04/12, patient states she noticed a rash on her lower legs, inflammation on both shoulder blades, internal discomfort in her sternum area. Rash continues, less inflammation on shoulder blades and less sternum discomfort. Saw PCP on 04/29, ordered steroid cream for legs and lab work.
72 2021-05-04 platelet count decreased red spots (petechiae) on my face; bleeding gums; platelets were down to 2; This spontaneous case was... Read more
red spots (petechiae) on my face; bleeding gums; platelets were down to 2; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (red spots (petechiae) on my face), GINGIVAL BLEEDING (bleeding gums) and PLATELET COUNT DECREASED (platelets were down to 2) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 012A21A) for COVID-19 vaccination. Concurrent medical conditions included High cholesterol. Concomitant products included SIMVASTATIN for High cholesterol. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 25-Mar-2021, the patient experienced PETECHIAE (red spots (petechiae) on my face) (seriousness criterion hospitalization), GINGIVAL BLEEDING (bleeding gums) (seriousness criterion hospitalization) and PLATELET COUNT DECREASED (platelets were down to 2) (seriousness criterion hospitalization). The patient was hospitalized from 26-Mar-2021 to 27-Mar-2021 due to GINGIVAL BLEEDING, PETECHIAE and PLATELET COUNT DECREASED. At the time of the report, PETECHIAE (red spots (petechiae) on my face), GINGIVAL BLEEDING (bleeding gums) and PLATELET COUNT DECREASED (platelets were down to 2) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Platelet count: 2 (Low) 2 and 49 (Inconclusive) Platelet count at 1:55 pm was 49.. On 29-Mar-2021, Platelet count: 117 (Inconclusive) 117. On 01-Apr-2021, Platelet count: 197 (Inconclusive) 197. On 19-Apr-2021, Platelet count: 144 (Inconclusive) 144. Treatment included platelet transfusion and steroids. On 28 Mar 2021, started with dexamethasone. On 01 Apr 2021, stopped steroids. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded This case was linked to MOD-2021-042955 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
72 2021-05-06 stroke 72 y.o. female with head and neck squamous cell carcinoma admitted to the hospital for left-sided we... Read more
72 y.o. female with head and neck squamous cell carcinoma admitted to the hospital for left-sided weakness LDL 132 Potassium 3.1 MRI brain showed acute to subacute right parietal and right frontal lobe infarct. CTA head and neck showed no significant stenosis HbA1c 5.2
72 2021-05-11 excessive bleeding Severe diarrhea, fissures formed , excruciating pain, bleeding
72 2021-05-12 heart rate decreased Patient complains of rash, throwing up, fever, chills, night sweats, dehydration, heart rate decreas... Read more
Patient complains of rash, throwing up, fever, chills, night sweats, dehydration, heart rate decrease, hospitalization in May for about a week.
72 2021-05-12 inflammation of the pericardium pericarditist; dizziness; block head; muscle pain/ body aches; soreness in the injected arm; fever; ... Read more
pericarditist; dizziness; block head; muscle pain/ body aches; soreness in the injected arm; fever; tiredness; flu like; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (pericarditist) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatoid arthritis since 1999, Blood pressure high since 2000 and Food allergy (lobster, crab). Concomitant products included AMLODIPINE and QUINAPRIL for Blood pressure high, METHOTREXATE for RA, IBUPROFEN for Rheumatoid arthritis, FOLIC ACID for an unknown indication. On 26-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2002, the patient experienced INFLUENZA LIKE ILLNESS (flu like). On 24-Feb-2021, the patient experienced DIZZINESS (dizziness), MYALGIA (muscle pain/ body aches) and VACCINATION SITE PAIN (soreness in the injected arm). 24-Feb-2021, the patient experienced HEAD DISCOMFORT (block head), PYREXIA (fever) and FATIGUE (tiredness). On 10-Apr-2021, the patient experienced PERICARDITIS (pericarditist) (seriousness criterion hospitalization). The patient was hospitalized from 10-Apr-2021 to 11-Apr-2021 due to PERICARDITIS. On 25-Feb-2021, INFLUENZA LIKE ILLNESS (flu like), DIZZINESS (dizziness), HEAD DISCOMFORT (block head), MYALGIA (muscle pain/ body aches), VACCINATION SITE PAIN (soreness in the injected arm), PYREXIA (fever) and FATIGUE (tiredness) had resolved. At the time of the report, PERICARDITIS (pericarditist) had resolved. The patient did not seek medical attention for the events that occurred on 24 Feb 2021. On 10 Apr 2021, the patient was hospitalized overnight with "pericarditist from unknown source". Treatment information for this event was not provided. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot e excluded. This case was linked to MOD-2021-026045 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Case upgraded per hospitalization for event of pericarditis. Patient completed the vaccine adverse event reporting form. Multiple fields updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot e excluded.
72 2021-05-12 transient ischaemic attack, atrial fibrillation Immediately after the vaccine I felt a forehead headache that went to the back of my head. I thought... Read more
Immediately after the vaccine I felt a forehead headache that went to the back of my head. I thought it would go away as week and a half and went to the doctor and found out I had a sinus infection. I've not had a sinus infection in a long time. Also, the doctor said that others had reported having headaches after the vaccine. Also two weeks to the day after the vaccine my eyes went funny and I couldn't ready or see properly and it was noted that I had a TIA and was diagnosed of having A-fib..
72 2021-05-13 atrial fibrillation, fast heart rate, palpitations, pallor, heart rate irregular 72 yo F presented for second dose of Moderna COVID-19 Vaccine. She had no issues with previous dose... Read more
72 yo F presented for second dose of Moderna COVID-19 Vaccine. She had no issues with previous dose. She was on her normal medications and used a single dose of her rescue albuterol inhaler with in 15 minutes of receiving her vaccine. Immediately following the administration of the vaccine, she began to feels lightheaded. She also felt flushed and her heart was racing. She started to have feelings of anxiety as well. She was placed in a 5 deg head low position. On initial exam, her speech was slow and difficult to hear. She was coherent and able to answer questions and give sxs. On initial exam she was pale. Non-labored breathing. He had a irregularly irregular pulse with a mild tachycardia with a rate in the 110's. She was hemodynamically stable with a BP in the 150's/90's. At this point EMS was called to transfer her to a location which could better assess her. further history was obtained from the patient including the recent dose of albuterol PMHx of CHF w a-fib and COPD She was moved to the procedure room via wheel chair and placed on pulse ox monitoring while leads were placed for an ECG. Her initial pulse ox was 93% and she was placed on O2 at 3l via NC. Her f/u BP was 120's/70's. EMS arrived, report was given and she was transferred to their care for transport to ED.
72 2021-05-19 heart rate abnormal still felt bad; weakness; body pain/sore arm; exhaustion, simply no energy, little tired/incredibly ... Read more
still felt bad; weakness; body pain/sore arm; exhaustion, simply no energy, little tired/incredibly tired/still feels a little tired; body aches (for 1st dose); sensation of her heart working so hard due to the shivering; patient thought going to have stroke or heart attack/feel like she was going to die; feel cold; fever was 101,developing a fever /fever was 101/104 degrees/mild fever of 100 degrees; dual headache, slight headache, headache worsened/bad headache; shivering so bad, waken by her shivering; nauseous/milder nausea; slept for 4 days constantly; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (patient thought going to have stroke or heart attack/feel like she was going to die) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Kidney atrophy in 2011. Concurrent medical conditions included Chronic kidney disease stage 3 (Left kidney is not functioning normally and had been diagnosed having chronic kidney stage 3.), Drug allergy (Medication allergies are; penicillin, cefdinir, erythromycin, bacterium, vancomycin, Zetia,) and Allergy (Latex and pepper spray). Concomitant products included LOSARTAN, PROPRANOLOL, LEVOTHYROXINE, CENTRUM SILVER +50, MAGNESIUM and PARACETAMOL (TYLENOL) for an unknown indication. On 29-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced NEAR DEATH EXPERIENCE (patient thought going to have stroke or heart attack/feel like she was going to die) (seriousness criterion medically significant), FEELING COLD (feel cold), HEART RATE ABNORMAL (sensation of her heart working so hard due to the shivering), PYREXIA (fever was 101,developing a fever /fever was 101/104 degrees/mild fever of 100 degrees), HEADACHE (dual headache, slight headache, headache worsened/bad headache), CHILLS (shivering so bad, waken by her shivering) and NAUSEA (nauseous/milder nausea). On 30-Mar-2021, the patient experienced FEELING ABNORMAL (still felt bad), ASTHENIA (weakness), PAIN (body pain/sore arm), FATIGUE (exhaustion, simply no energy, little tired/incredibly tired/still feels a little tired) and MYALGIA (body aches (for 1st dose)). On an unknown date, the patient experienced HYPERSOMNIA (slept for 4 days constantly). On 30-Mar-2021, FEELING COLD (feel cold), PYREXIA (fever was 101,developing a fever /fever was 101/104 degrees/mild fever of 100 degrees), HEADACHE (dual headache, slight headache, headache worsened/bad headache), CHILLS (shivering so bad, waken by her shivering) and NAUSEA (nauseous/milder nausea) had resolved. On 31-Mar-2021, FEELING ABNORMAL (still felt bad), ASTHENIA (weakness), PAIN (body pain/sore arm), FATIGUE (exhaustion, simply no energy, little tired/incredibly tired/still feels a little tired) and MYALGIA (body aches (for 1st dose)) had resolved. At the time of the report, NEAR DEATH EXPERIENCE (patient thought going to have stroke or heart attack/feel like she was going to die) and HYPERSOMNIA (slept for 4 days constantly) had resolved and HEART RATE ABNORMAL (sensation of her heart working so hard due to the shivering) outcome was unknown. Event is serious as per Important medical event terms list (MedDRA version 24.0) DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 104 degrees (Inconclusive) 104 degrees. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient stated that her symptoms were so bad from the first dose that she thought she was going to have a stroke or a heart attack and her fever was up to 104 degrees. She took Tylenol ( acetaminophen) for treatment. Today, 06-May-2021, the patient stated that she feels much more like herself but still feels a little tired. Treatment details include, acetaminophen. Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, fever, nausea chills fatigue and myalgia are consistent with the product safety profile. This case was linked to MOD-2021-109712 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Events added, concomitant drug added.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, fever, nausea chills fatigue and myalgia are consistent with the product safety profile.
72 2021-05-19 transient ischaemic attack TIA; Slurred speech; This spontaneous case was reported by a consumer and describes the occurrence o... Read more
TIA; Slurred speech; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 030M20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 05-Apr-2021 to 07-Apr-2021 due to TRANSIENT ISCHAEMIC ATTACK. On 07-Apr-2021, TRANSIENT ISCHAEMIC ATTACK (TIA) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications and treatment information was not provided by the reporter. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD21-087942 (E2B Linked Report). This case was linked to MOD-2021-114502 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD21-087942:2nd dose
72 2021-05-21 chest discomfort The week of the injection I had headache, fatigue, and a constriction high in my chest if I breathed... Read more
The week of the injection I had headache, fatigue, and a constriction high in my chest if I breathed in deeply. The restriction in my chest continued past the first week but did not interfere with aerobic exercise even when it developed into an intermittent small cough. Seven weeks later, I felt very fatigued, sick. At urgent care, based on a chest x-ray, I was diagnosed with pneumonia and prescribed an antibiotic. A week later, I returned to urgent care because I felt my lungs were not healed, and I was told that it had not been pneumonia after all. This was after a second x-ray which still showed fuzziness and cloudiness in my lungs. All lab tests were normal except for c-reactive protein, which was 43. I use an inhaler 2x a day (abuterol), which helps to open my bronchioles. I am still fatigued and must ration my activities each day to allow for hours of rest.
72 2021-05-21 loss of consciousness, cerebrovascular accident Massive stroke from huge clot right of brain. Never regained con..
72 2021-05-23 blood pressure increased, cerebral haemorrhage Tremors (could not walk, lost sight in both eyes, Extremely high BP (220/110), Could not breathe (pu... Read more
Tremors (could not walk, lost sight in both eyes, Extremely high BP (220/110), Could not breathe (put on ventilator in ICU), Found blood in brain) Fluid built up in lungs. All over 4 1/2 days starting on 05/08/2021
72 2021-05-23 fast heart rate PT WENT TO HOSPITAL FOR TACHCARDIA THE DAY AFTER RECEIVING VACCINATION.
72 2021-05-24 hypertension Patient is stating since she has had the vaccine she has had high blood pressure, feeling hot, and t... Read more
Patient is stating since she has had the vaccine she has had high blood pressure, feeling hot, and the chills.
72 2021-05-25 loss of consciousness Loss of consciousness; Malaise; Pyrexia; This case was received via FDA VAERS on 11-May-2021 and was... Read more
Loss of consciousness; Malaise; Pyrexia; This case was received via FDA VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoarthritis, Osteoporosis, GERD, Hypercholesterolemia, Irritable bowel syndrome, Hypothyroidism, Hypertension, Diabetes mellitus and Coronary atherosclerosis. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, UBIDECARENONE (COQ10 [UBIDECARENONE]), DOCUSATE SODIUM, BIFIDOBACTERIUM LACTIS, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS (FLORAJEN3), GLIPIZIDE, LEVOTHYROXINE, OMEPRAZOLE, INSULIN DEGLUDEC (TRESIBA), VALSARTAN, VITAMIN D3 and ZOLEDRONIC acid for an unknown indication. On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (Pyrexia). On 26-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant) and MALAISE (Malaise). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), MALAISE (Malaise) and PYREXIA (Pyrexia) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood glucose: 142 mg/dl (abnormal) 142 mg/dl. On 26-Feb-2021, Blood pressure measurement: 117/60 (normal) normal, Earlier it was noted to be in the 90s systolic. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. On night of 25-Feb-2021. The patient reported running a fever. On 26-Feb-2021, the patient woke up with not feeling well. The patient's blood sugar was checked which was 142 mg/dl and shortly after she passed out. The patient's blood sugar was noted to be in the 90's systolic as taken by her daughter, who was a nurse. On re-checking the patient's blood pressure, it got improved to 117/60. The patient was scheduled to be seen with her primary care provider on 26-Feb-2021 to verify that the patient was stable. Company Comment: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.
72 2021-05-28 hypertension, inflammation of the pericardium Weakness, lightheaded, high blood pressure, inability to take deep breath, less able to breath lying... Read more
Weakness, lightheaded, high blood pressure, inability to take deep breath, less able to breath lying down - needed to sit up. Diagnosed at Hospital with Pericarditis. Treatments: MRI of head and chest, EKG, Nitroglycerin, Echo cardiogram, blood test, prescription to cure inflamation of sack around heart. Greatly improved in 2 days. Final stress test and blood test showed pericarditis resolved.
72 2021-06-03 cerebrovascular accident I63.9 - Acute CVA (cerebrovascular accident)
72 2021-06-03 palpitations Heart skips beats Felling faint Extremely tired Wanting to sleep all the time No Energy
72 2021-06-07 cerebrovascular accident Pt had an occipital stroke on the 13th of March. She lost half of her vision in both eyes. We went t... Read more
Pt had an occipital stroke on the 13th of March. She lost half of her vision in both eyes. We went to the hospital after the eye doctor told her she had had a stroke. Eventually, after 4 trips to the hospital, 2 trips to rehab, we discovered the strokes apparently triggered non-convulsive seizures which they could never end up getting under control. She passed away on 31 May 2021.
72 2021-06-08 dilation of blood vessels Hours after vaccination patient developed vomiting, weakness, low-grade fever, difficulty breathing,... Read more
Hours after vaccination patient developed vomiting, weakness, low-grade fever, difficulty breathing, feeling of pins-and-needles all over the body. Patient had the symptoms for 1 week then most of them subsided. Patient continues having neuropathy in both feet right more than left with difficulty walking in the morning. Patient also has dilated veins in the skin over the right shoulder where she got injection of the vaccine.
72 2021-06-09 palpitations, blood pressure increased, heart rate increased Patient stated she received here 2nd COVID-19 Vaccination on 06/07/2021. Patient stated that she rec... Read more
Patient stated she received here 2nd COVID-19 Vaccination on 06/07/2021. Patient stated that she received her vaccination at 10:00am. Patient stated that right away she started feeling burning, soreness, weakness in arm, rash, and hot to the touch. Patient stated later in the day she started having elevated blood pressure, stiff arm, super fatigue and sleeping to much, anxious, palpitation, slightly elevated heart rate at 99, and lower grade fever. Patient stated today (06/10/2021) that her arm is still very sore, red, swollen, fatigue, and stiff arm.
72 2021-06-10 cerebrovascular accident Her surgery in the morning went very well according to her doctor. Later in the afternoon, pt. had ... Read more
Her surgery in the morning went very well according to her doctor. Later in the afternoon, pt. had a massive stroke. Next day pt. died at Hospital .
72 2021-06-10 inflammation of the pericardium Severe muscle spasms started under my left shoulder blade after 1st injection, not relating it to th... Read more
Severe muscle spasms started under my left shoulder blade after 1st injection, not relating it to the vaccine went to chiropractors thinking it was muscles or bones out of place. After seeing 3 chiropractors and receiving no help it was suggested to see my family practice doctor. By then my breathing was severely compromised, my dr. sent me to have a chest x-ray to check for blockages, then sent me to the emergency room where a CT scan was done, EKG which was probably out of whack because of pain and breathing difficulty experienced - IV pain meds were administered. Breathing became somewhat better when pain was less. Unrelenting muscle spasms continued, terrible pain in the upper left back and upper chest area, lived on Ibuprofen and tylenol for several days. On the day of the second vaccination I was scheduled for ultrasound of arteries and veins in legs to check for clots, there were no clots. Still not realizing the pain was related to the covid vaccine I went ahead with the second vaccination. Since my arms and shoulders were already in so much pain it was decided the right hip would be the site for the injection. That same night muscle spasms developed from my hips going up all the way through my back. I completely lost my appetite and didn't eat anything for about 10 days, lost 15 lbs. Lost all interest in life, could have cared less if I lived or died. Again I went back to see my family dr., she prescribed muscle relaxers which didn't help at all. It was decided to make an appointment with a cardiologist where it was discovered that I have pericarditis or inflammation in my heart. I am now on medication. It's been a long road to recovery and I won't be taking any other covid vaccinations.
72 2021-06-11 atrial fibrillation, heart failure PT REPORTS BEING PREVIOUSLY ACTIVE AND HEALTHY, 4 DAYS AFTER RECEIVING VACCINE SHE PRESENTED TO ER W... Read more
PT REPORTS BEING PREVIOUSLY ACTIVE AND HEALTHY, 4 DAYS AFTER RECEIVING VACCINE SHE PRESENTED TO ER WITH A. FIB AND HEART FAILURE. PT UNDERWENT CARDIOVERSION ON 3/15 AND REPORTS 4 NORMAL EKG'S SINCE. PT DOES NOT REPORT A RE-EVALUATION OF INJECTION FRACTION SINCE. PT RECEIVED 2ND DOSE ON 3/4 BUT THOUGHT THEY MIGHT BE RELATED SINCE SEEING REPORTS OF HEART ISSUES FOLLOWING VACCINATION
72 2021-06-13 ischemic chest pain, inflammation of the pericardium, chest pain Weakness, extreme pain all over, limitation of movement, chest pain. Symptoms began about 1 mo post ... Read more
Weakness, extreme pain all over, limitation of movement, chest pain. Symptoms began about 1 mo post second vaccine and became progressively worse over time. I went to the ER 5/11/21. Then again on 5/17/21. I was admitted to the hospital on 5/17/21 and DX with pericarditis. I also went to the ER on 5/24/21 for pain related to the pericarditis.
72 2021-06-14 hypertension, atrial fibrillation all list adverse reactions were experienced: fatigue, muscular aches, headaches, fever and chills, ... Read more
all list adverse reactions were experienced: fatigue, muscular aches, headaches, fever and chills, profuse sweats, extreme shortness of breath...all of which sent me into fib and high blood pressure.
72 2021-06-14 hypotension Patient presented with acute onset of hypotension diaphoresis and altered mental status that was acu... Read more
Patient presented with acute onset of hypotension diaphoresis and altered mental status that was acute in onset. Also reports diffuse abdominal cramping and multiple episodes of diarrhea.
72 2021-06-15 hypertension lost the ability to walk; was in so much pain she wanted to die; high blood pressure; didn't feel we... Read more
lost the ability to walk; was in so much pain she wanted to die; high blood pressure; didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (lost the ability to walk) and PAIN (was in so much pain she wanted to die) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (lost the ability to walk) (seriousness criterion hospitalization), PAIN (was in so much pain she wanted to die) (seriousness criterion hospitalization), HYPERTENSION (high blood pressure) and MALAISE (didn't feel well). At the time of the report, GAIT INABILITY (lost the ability to walk), PAIN (was in so much pain she wanted to die), HYPERTENSION (high blood pressure) and MALAISE (didn't feel well) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. Treatment medication includes Antibiotics. Company Comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
72 2021-06-16 loss of consciousness Feeling unwell; rash; passed out; Disorientation; Chills; Headache; Hives in the whole body; Itching... Read more
Feeling unwell; rash; passed out; Disorientation; Chills; Headache; Hives in the whole body; Itching at the injection site; Sore injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure abnormal, Sleep disorder NOS, Herpes NOS since 1980 and Hypothyroidism since 1975. Concomitant products included TELMISARTAN (MICARDIS) for Blood pressure abnormal, VALACYCLOVIR [VALACICLOVIR] for Herpes NOS, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DIAZEPAM (VALIUM) for Sleep difficult, LEVOTHYROXINE SODIUM (LEVOXYL), ACYCLOVIR [ACICLOVIR], PYRIDOXINE HYDROCHLORIDE (B6) and COLECALCIFEROL (D3) for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site). On 27-Jan-2021, the patient experienced URTICARIA (Hives in the whole body), VACCINATION SITE PRURITUS (Itching at the injection site) and HEADACHE (Headache). On 28-Jan-2021, the patient experienced DISORIENTATION (Disorientation) and CHILLS (Chills). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MALAISE (Feeling unwell) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of Expired; PREDNISONE at a dose of 20 mg; SERTRALINE HYDROCHLORIDE (SERTAC) at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of 2 days and FLUOCINOLONE ACETONIDE (topical) for Rash, at a dose of 2 days. At the time of the report, LOSS OF CONSCIOUSNESS (passed out) and VACCINATION SITE PRURITUS (Itching at the injection site) had resolved and DISORIENTATION (Disorientation), URTICARIA (Hives in the whole body), MALAISE (Feeling unwell), RASH (rash), VACCINATION SITE PAIN (Sore injection site), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: inconclusive (Inconclusive) Inconclusive. On an unknown date, COVID-19: negative (Negative) Negative. On an unknown date, Cognitive test: inconclusive (Inconclusive) Inconclusive. On an unknown date, Computerised tomogram: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was treated with IV steroids , Topical oil for rash . Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Case updated to Serious , Patient details, conmeds, treatment medications added On 26-May-2021: contact information , Second dose details updated .; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
72 2021-06-20 deep vein blood clot, pulmonary embolism DVT, PE with life-threatening ischemia Apixaban 5mg BID for 6 months followed by 2.5mg BID thereafte... Read more
DVT, PE with life-threatening ischemia Apixaban 5mg BID for 6 months followed by 2.5mg BID thereafter IVC Filter retrieval
72 2021-06-21 atrial fibrillation, heart rate increased Arterial fibrillation; Blood in stool for one time event after the 1st dose; Very very rapid heart b... Read more
Arterial fibrillation; Blood in stool for one time event after the 1st dose; Very very rapid heart beat after the 1st dose/ Increased heart rate that she can hear her heart beat sound after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool for one time event after the 1st dose) and ATRIAL FIBRILLATION (Arterial fibrillation) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN HYDROCHLOROTHIAZIDE) and ROSUVASTATIN for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEART RATE INCREASED (Very very rapid heart beat after the 1st dose/ Increased heart rate that she can hear her heart beat sound after the 1st dose). On 31-Mar-2021, the patient experienced HAEMATOCHEZIA (Blood in stool for one time event after the 1st dose) (seriousness criterion medically significant). On an unknown date, the patient experienced ATRIAL FIBRILLATION (Arterial fibrillation) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) (oral) on 28-May-2021 at a dose of UNK UNK, bid. On 31-Mar-2021, HAEMATOCHEZIA (Blood in stool for one time event after the 1st dose) had resolved. On 21-Apr-2021, HEART RATE INCREASED (Very very rapid heart beat after the 1st dose/ Increased heart rate that she can hear her heart beat sound after the 1st dose) had resolved. At the time of the report, ATRIAL FIBRILLATION (Arterial fibrillation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient had never experienced any heart trouble before. The patient was referred to a cardiologist. The patient was scheduled for an echocardiogram (ECHO) and a positron emission tomography (PETSCAN). Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-216160 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received: updated information since patient was scheduled for ECHO and PET scan by cardiologist.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
72 2021-06-21 chest pain, chest discomfort Pt called pharmacy morning after reporting chest pain and tightness, body aches, headache/head pain... Read more
Pt called pharmacy morning after reporting chest pain and tightness, body aches, headache/head pain radiating down to her neck. Symptoms were present when she woke up; pt lives alone with no transportation. Reports being able to take full breaths but doing so causes more tightness and pain. Per patient, she is on antihypertensives, "heart medications", and thyroid medication. Due to chest pain and tightness in conjunction with patient's inability to receive prompt medical attention, pt was advised to call 911 to verify chest pain did not originate from other potential conditions. Pt verbalized understanding.
72 2021-06-21 fast heart rate Hyperventilation , tachychardia, and abnormal fatigue during and after mundane activities. Occassio... Read more
Hyperventilation , tachychardia, and abnormal fatigue during and after mundane activities. Occassional light headedness. Swelling and edema in lower extremities. Aches/discomfort in both arms at times.
72 2021-06-22 ischemic chest pain, palpitations, inflammation of the pericardium 3 days after the first dose of Moderna, symptoms of pericarditis became evident. Heart pain, palpi... Read more
3 days after the first dose of Moderna, symptoms of pericarditis became evident. Heart pain, palpitations, & shortness of breath. On anti inflammatory til 3 days before the second dose. Heart inflammation continued after 2nd dose. Resumed high doses of anti inflammatory. Made 2 trips to Emergency Room due to increased symptoms. Eventually put on Colchicine. After 5-6 wks on Colchicine, the heart inflammation has calmed down. There were no other reasons or explanations for the heart inflammation....no injury, infection, or virus.
72 2021-06-22 chest discomfort The next day it felt like someone had beat me up. I had total body aches I felt like I was a punchin... Read more
The next day it felt like someone had beat me up. I had total body aches I felt like I was a punching bag; headaches were the worst. They were exploding. It was the worst headache I ever, ever had and I get migraines all the time. Body aches went away by Monday afternoon or Tuesday morning. Headaches still continued for about three weeks but not like the initial ones. I still get the headaches today. I called the doctor and he said it was a common side effect. Advil Liquid gels is what I took for the pain and I needed them for a while. By April, I was okay, but my headaches were more intense than before the vaccine. Then in May, about the 12th, I lost my voice. I was rasping or trying to speak. No one could understand me. There was a cough in my chest. My voice still fluctuates but it is back. It's just deeper and it's not completely back - I sound like I'm winded but I'm not winded physically at all. I called my doctor and spoke with nurse, and they gave me Levaquin, but I already had some and it was 500 mg for five days. Heaviness in my lungs went away even though voice was still raspy. Just waiting now for the voice to come back completely.
72 2021-06-23 heart rate increased, atrial fibrillation Rapid heart beat and A-Fib
72 2021-06-24 atrial fibrillation I was very sick to my stomach, I had severe stomach pain. I started throwing up and was dry heaving... Read more
I was very sick to my stomach, I had severe stomach pain. I started throwing up and was dry heaving, when I got to the hospital I found out I had C diff, a UTI, and the hospital admitted me I spent 3 weeks in the hospital. I was in 2 separate hospitals for a total of 7 weeks. I had serious complications, I went into A fib with my heart, I got neuropathy from my chest down I was numb all over. I had severe UTIs, they kept putting catheters in me. I was so sick I couldn't eat and I lost 35lbs. I thought I was going to die.
72 2021-06-24 blood pressure decreased I had a headbanging headache. I still get them on and off. My headaches are usually associated with ... Read more
I had a headbanging headache. I still get them on and off. My headaches are usually associated with sinus pressure. My sinuses my eyebrows, cheeks, face everywhere hurt. I thought it was a sinus infection. The doctor was going to prescribe me medication. I did not experience green mucus that usually accompanies the sinus infection. In addition to that I had severe hives. It looked like someone had thrown boiling water at my torso. They were going to prescribe me prednisone. I did not want that because I am a healthy person and they told me that the prednisone could compromise my immune system. I wound up with a dry mouth and the inside of my mouth hurt. I had talked to friends who had COVID and they said they experienced thrush. I did not have the white spots associated with thrush though. After 3 weeks, I went to the doctor and asked if it was possible I had a yeast infection in my body. They prescribed nystatin and from there things got worse. I went back in and they told me to stop the nystatin because my blood pressure was bottoming out. I have never had an issue with blood pressure before. I was experiencing dizziness after standing up. After stopping the nystatin, and getting the Holter monitor I experienced an episode of dizziness. I feel my mouth is starting to get better. I do have some tingling around my lips. I felt like I had Botox shots around my lips.
72 2021-06-27 chest discomfort, blood pressure increased I could feel my chest tighting as i was receiving the rejection. They took my blood pressure and it ... Read more
I could feel my chest tighting as i was receiving the rejection. They took my blood pressure and it was 225/114 and they kept checking it every 8 minutes for about 45 minutes. It wouldn't come down for a few hours. It finally started to go down and she sent me home with a blood pressure and informed me to keep check on it and if it started to rise again to go to a clinic.
72 2021-07-01 arrhythmia, chest pain chest pain; pain in my left breast especially under the breast; felt like a large weight had been pl... Read more
chest pain; pain in my left breast especially under the breast; felt like a large weight had been placed on my center chest causing my breathing to be very uncomfortable; felt like heart arrhythmia; does feel like someone hit her with brass knuckles in the arm; The pain in my left arm was much more painful than the first; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (felt like heart arrhythmia) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sulfonamide allergy, Drug allergy, Food allergy, Drug allergy and Reaction to drug preservatives. Concomitant products included CURCUMA LONGA RHIZOME (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]), LEVOTHYROXINE SODIUM (SYNTHYROID), COLECALCIFEROL (D3) and RESVERATROL for an unknown indication. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced FEELING ABNORMAL (does feel like someone hit her with brass knuckles in the arm) and VACCINATION SITE PAIN (The pain in my left arm was much more painful than the first). On 31-Mar-2021, the patient experienced ARRHYTHMIA (felt like heart arrhythmia) (seriousness criterion medically significant), BREAST PAIN (pain in my left breast especially under the breast) and DYSPNOEA (felt like a large weight had been placed on my center chest causing my breathing to be very uncomfortable). On an unknown date, the patient experienced CHEST PAIN (chest pain). In April 2021, ARRHYTHMIA (felt like heart arrhythmia), BREAST PAIN (pain in my left breast especially under the breast) and DYSPNOEA (felt like a large weight had been placed on my center chest causing my breathing to be very uncomfortable) had resolved. At the time of the report, FEELING ABNORMAL (does feel like someone hit her with brass knuckles in the arm), CHEST PAIN (chest pain) and VACCINATION SITE PAIN (The pain in my left arm was much more painful than the first) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: abnormal (abnormal) Minimal leaky valve issue. In 2021, Echocardiogram: abnormal (abnormal) Minimal leaky valve issue.. It was reported that the pain in patient's left arm was much more painful than the first, followed by 36 hours later, what she felt like heart arrhythmia, in her left breast especially under the breast, and she felt like a large weight had been placed on her center chest causing her breathing to be very uncomfortable. She had to see DR once again. After a CAT scan, cardiogram & ECHO cardio, doctor came up with a minimally leaky valve issue, which was known and was not a problem. She is happy and relieved to say that she have none of the side effects of the Moderna vaccine. She reported that it took at least 3 weeks for the breast pain & chest pain and weird heart flutters to completely fade. No treatment medications were provided. This case was linked to US-MODERNATX, INC.-MOD-2021-064049 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Updated Patient details, medical history, concomitant medications, batch or lot number, updated events.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-064049:1st dose
72 2021-07-01 cardio-respiratory arrest Client was vaccinated on 2-3-21. She stated her only side effect was some mild "confusion". she and... Read more
Client was vaccinated on 2-3-21. She stated her only side effect was some mild "confusion". she and her husband left on 2-14-21. On 2-19-21 she called EMS because "something just felt wrong". She reports coding twice upon entering the emergency room area at Hospital. She reports having a blood clot and needed to have 3 stents put in along with a pacemaker. She was discharged on 2-25-21. On 2-27-21 she was readmitted to the same hospital for 2nd pacemaker. She has recovered and feels good with weakness and fatigue. She returned home on 5-10-21 and sent a letter to the Health District concerning the blood clot.
72 2021-07-07 heart rate increased Shortness of breath, difficulty breathing, fast heart beat, pressure neck (all events happened short... Read more
Shortness of breath, difficulty breathing, fast heart beat, pressure neck (all events happened shortly after administration of covid vaccine)
72 2021-07-08 palpitations I have been experiencing this month more fatigue than usual. My face also feels flushed occasionally... Read more
I have been experiencing this month more fatigue than usual. My face also feels flushed occasionally which I did not have before and I get very dizzy. When getting up from a bed I get extremely dizzy and I have to sit down. I continue with SOB that comes and goes and my heart palpitations are still present but not as frequent as before.
72 2021-07-10 atrial fibrillation Atrial fibrillation; Blood in stool again for one time only after the 2nd dose/She also mentioned th... Read more
Atrial fibrillation; Blood in stool again for one time only after the 2nd dose/She also mentioned that she had blood in the stool twice, first time was after the first shot and second time after the Second shot.; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) and HAEMATOCHEZIA (Blood in stool again for one time only after the 2nd dose/She also mentioned that she had blood in the stool twice, first time was after the first shot and second time after the Second shot.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 048A21A) for COVID-19 vaccination. Concurrent medical conditions included Shellfish allergy and Chronic kidney disease (Improved). Concomitant products included HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN HYDROCHLOROTHIAZIDE), ROSUVASTATIN, AMLODIPINE from 06-Mar-2021 to an unknown date and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HAEMATOCHEZIA (Blood in stool again for one time only after the 2nd dose/She also mentioned that she had blood in the stool twice, first time was after the first shot and second time after the Second shot.) (seriousness criterion medically significant). On 21-Apr-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Anticoagulant therapy, at a dose of UNK, bid. On 17-Apr-2021, HAEMATOCHEZIA (Blood in stool again for one time only after the 2nd dose/She also mentioned that she had blood in the stool twice, first time was after the first shot and second time after the Second shot.) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products included multivitamin. The action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-216141 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received contains no new information. On 01-Jul-2021: Follow up received on 01-Jul-2021, no new information was recorded On 02-Jul-2021: Reporter details, patient details, medical history, concomitant drugs were added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
72 2021-07-11 arrhythmia Irregular heartbeat started when contracted Covid-19 in October 2020. Exacerbated again after recei... Read more
Irregular heartbeat started when contracted Covid-19 in October 2020. Exacerbated again after receiving both doses of the Moderna vaccine. Since October 2020 to present, she has had two event monitors placed. One event monitor was 2 weeks in length, the other was 30 days in length. She is a patient of cardiologist, Dr. She has also seen electrophysiologist, Dr. and internist Dr. She has an appointment for a second opinion on 8/2/2021 with electrophysiologist Dr. She has been treated for high cholesterol for the past 40 plus years. She has been treated for hypertension for the past 40 plus years. Starting with Covid-19 in October 2020, she has had the sensation of ?needles sticking up? which goes around the neck, up to the ears, and along each joint of her jaw. She was placed on a blood thinner by Dr. around 6/2/2021. Dr. also has placed her on Diltiazem to treat her blood pressure issue. As of today, 7/6/21, the sensation is subsiding and is nothing like when she had Covid-19.
72 2021-07-11 blood clot in the brain, cerebrovascular accident Face was sore and noticed drooping left side, tongue went off to the left, went to the hospital whe... Read more
Face was sore and noticed drooping left side, tongue went off to the left, went to the hospital where she got a stoke. TPA through IV.
72 2021-07-11 fluid around the heart Patient presented to our hospital 6/29/21 with x 3-4 weeks of progressive dyspnea on exertion and dr... Read more
Patient presented to our hospital 6/29/21 with x 3-4 weeks of progressive dyspnea on exertion and dry cough. She was subsequently found to have a pericardial effusion s/p pericardiocentesis and drain placement on 6/30. Fluid analysis was not indicative of bacterial pericarditis and blood+pericardial fluid cultures are no growth (fluid 37% neutrophils, 54% monos, 5% lymphs, normal glucose. Reportedly 750 mL of straw colored fluid was removed during the pericardiocentesis. The pericardial drain was left in place. RPR is negative. Path report from 6/30 pericardial fluid indicated no malignant cells seen, "by immunochemistry the epithelial cells are positive for cytokeratin 7, calretinin and WT-1, and negative for estrogen receptor, GATA-3, BerEP4, CDX-2, PAX-8, Claudin-4, TTF-1, p40, and keratin 20. Reactive mesothelial cells are favored." Unfortunately she did have subsequent reaccumulation of her pericardial fluid s/p redrain and growing Proteus on 7/8, now being treated as a suppurative pericarditis. Thought is that she did not initially present with bacterial infection, but subsequently developed Proteus infection from drains and surgical exposures. No history of trauma nor immune disease. She reports no history of imbedded ticks nor erythema migrans, but we are sending for Lyme serologies. We are also sending for galactomannan and enterovirus PCR.
72 2021-07-13 anaemia pneumonia; general swelling; pain; anemic; protein was 2.0/ low protein; platelets test was over 800... Read more
pneumonia; general swelling; pain; anemic; protein was 2.0/ low protein; platelets test was over 800,000; general edema; extreme fatigue; migraine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PNEUMONIA (pneumonia) and SWELLING (general swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced SWELLING (general swelling) (seriousness criterion hospitalization), MIGRAINE (migraine), GENERALISED OEDEMA (general edema) and FATIGUE (extreme fatigue). On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant), PAIN (pain), ANAEMIA (anemic), PROTEIN TOTAL DECREASED (protein was 2.0/ low protein) and PLATELET COUNT INCREASED (platelets test was over 800,000). At the time of the report, PNEUMONIA (pneumonia), SWELLING (general swelling), PAIN (pain), MIGRAINE (migraine), ANAEMIA (anemic), PROTEIN TOTAL DECREASED (protein was 2.0/ low protein), PLATELET COUNT INCREASED (platelets test was over 800,000), GENERALISED OEDEMA (general edema) and FATIGUE (extreme fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: > 800,000 > 800,000. On an unknown date, Protein total: 2.0 2.0. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was given narcotics for pain. Low protein was treated with albumin. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
72 2021-07-14 superficial blood clot Initial adverse reactions evening of 6/30/2021, days of 7/1-2/21: extreme fatigue, low grade fever,... Read more
Initial adverse reactions evening of 6/30/2021, days of 7/1-2/21: extreme fatigue, low grade fever, body aches, bad headache. chills. 2nd more severe adverse reaction - 7/10/21: Upon awakening Saturday, 7/10: extreme pain, swelling of right hand below third joint of thumb to past the right wrist. swollen lump on surface vein below thumb. Tender to touch, warmer than surrounding skin, with red, purplish discoloration. Unable to turn wrist, overwhelming pain. Unable to use hand. Lasted a couple of days. Hard lump in vein still remains. Consulting with a Cardiologist, he diagnosed it as a Superficial Thrombophlebitis and recommended taking an NSAID med and using warm compresses, as well as raising arm above heart.
72 2021-07-15 inflammation of the heart muscle, heart rate irregular I was admitted to the hospital with pain in shoulder and nausea. Did cardiac catheterization and I w... Read more
I was admitted to the hospital with pain in shoulder and nausea. Did cardiac catheterization and I was diagnosed with myocarditis. Was sent home the next day and was prescribed Toprorol 12.5 mg daily. Seeing cardiologist and just wore a heart monitor for 24 hours because of irregular heart beats and shortness of breath. Continues to follow up with cardiologist
72 2021-07-19 heart rate increased, hypotension Within 1-2 minutes of receiving the vaccine, I experienced paresthesias from my diaphragm to my toes... Read more
Within 1-2 minutes of receiving the vaccine, I experienced paresthesias from my diaphragm to my toes and an overall sense of "something is wrong here." I was walking around the office to pass the time and felt that my legs were going to buckle if I didn't sit down. Sat & continued to experience the paresthesias & sense of "uh-oh." Finally reported symptoms to staff. When checked out by RN, had a lowered BP and an increased heart rate. After an hour, I felt that I could walk again & went home. Symptoms resolved after another few hours.
72 2021-07-19 loss of consciousness 2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and... Read more
2/19/2021; 15 days after receiving 1st Moderna vaccine. Pt had no complaints other than sore arm and tiredness after vaccination. Skiing with family; walking in ski boots to get skis on. She complained of sudden onset of headache and "not feeling well". Ski patrol was nearby and got her a glass of water. Patient stood up and fell to the ground unconscious. Taken to ski patrol hut; unresponsive with left sided deficits, snoring respirations & trisamus present. Unable to transport to major medical center due to adverse weather. Taken by ambulance to local hospital. CT showed significant hyperdense acute intracranial blood including lateral ventricles, 3rd & 4th ventricles with parenchymal blood in right greater than left bilateral parietal periventricle regions. Left midline shift. ER Physician: Transported to Medical Center via air & then ambulance due to adverse weather. Overnight in Neuro ICU; brain dead; organ donation.
72 2021-07-19 inflammation of the heart muscle Myocarditis
72 2021-07-19 inflammation of the pericardium, fluid around the heart pericardial effusion with tamponade and pericarditis
72 2021-07-20 superficial blood clot, deep vein blood clot, blood clot Lump in vein; blood clot on hand; Superficial thrombophlebitis; Negative reaction/Most severe reacti... Read more
Lump in vein; blood clot on hand; Superficial thrombophlebitis; Negative reaction/Most severe reaction/delayed reaction; Woke up in extreme pain, wave of huge pain/extreme pain / pain was overwhelming./ Painful; Badly swollen hand,Swollen/ swelling of right hand: from below last thumb joint to past wrist/ Swollen lump on surface vein below thumb/ swelling was too restrictive; Warm/warmer than surrounding skin; Tender/tender to touch; Could not move hand and wrist/ Unable to use hand/Unable to turn wrist; Panicked; swelling of right hand: from below last thumb joint to past wrist; purplish discoloration/red discoloration; Redness/erythema local/ with red; frightening experience; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021. This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Lump in vein) and THROMBOSIS (blood clot on hand) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 005C21AAAAA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Carpal tunnel syndrome (More painful) since 1998. Previously administered products included for Product used for unknown indication: FLU (welts on upper torso) in 1996. Concurrent medical conditions included Vascular disorder NOS (Vascular issue), Vein disorder (Clogged lower vein), Allergic to cats, Hypertension since 2003, Hyperlipidemia since 2003, Type 2 diabetes mellitus since 2004, Neuropathy since 2004, Osteoarthritis since 2006, Left bundle branch block since 2006, Cholesterol, Allergy to antibiotic (Allergic to ampicillin - felt ill, nauseous.), Sulfonamide allergy (Allergic to Sulfa drugs - difficulty breathing), Allergy to nuts (Allergic to almond - swelling of tongue, mild to moderate), Drug allergy (Allergic to other -cillin meds-no antibiotic reaction, caused nausea.), Perfume sensitivity (Allergic to chemical fragrances a used some allergic asmtha, issue has mostly gone/resolved itself) and Allergic asthma. Concomitant products included LOSARTAN POTASSIUM and LABETALOL HCL for Blood pressure, SIMVASTATIN for Cholesterol, UBIQUINOL for Energy increased, GABAPENTIN for Pain management, IRON for Supplementation therapy, METFORMIN HCL for Type 2 diabetes mellitus, HORSE CHESTNUT EXTRACT for Vein disorder. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced DEEP VEIN THROMBOSIS (Lump in vein) (seriousness criterion medically significant), THROMBOSIS (blood clot on hand) (seriousness criterion medically significant), THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombophlebitis), VACCINATION COMPLICATION (Negative reaction/Most severe reaction/delayed reaction), PAIN IN EXTREMITY (Woke up in extreme pain, wave of huge pain/extreme pain / pain was overwhelming./ Painful), PERIPHERAL SWELLING (Badly swollen hand,Swollen/ swelling of right hand: from below last thumb joint to past wrist/ Swollen lump on surface vein below thumb/ swelling was too restrictive), FEELING HOT (Warm/warmer than surrounding skin), TENDERNESS (Tender/tender to touch), MOBILITY DECREASED (Could not move hand and wrist/ Unable to use hand/Unable to turn wrist), PANIC REACTION (Panicked), JOINT SWELLING (swelling of right hand: from below last thumb joint to past wrist), SKIN DISCOLOURATION (purplish discoloration/red discoloration), ERYTHEMA (Redness/erythema local/ with red) and FEELING ABNORMAL (frightening experience). The patient was treated with VITIS VINIFERA SEED (GRAPE SEED EXTRACT [VITIS VINIFERA SEED]) for Vascular disorder NOS, at an unspecified dose and frequency. On 12-Jul-2021, THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombophlebitis), VACCINATION COMPLICATION (Negative reaction/Most severe reaction/delayed reaction), FEELING HOT (Warm/warmer than surrounding skin), TENDERNESS (Tender/tender to touch), MOBILITY DECREASED (Could not move hand and wrist/ Unable to use hand/Unable to turn wrist), PANIC REACTION (Panicked), JOINT SWELLING (swelling of right hand: from below last thumb joint to past wrist), SKIN DISCOLOURATION (purplish discoloration/red discoloration), ERYTHEMA (Redness/erythema local/ with red) and FEELING ABNORMAL (frightening experience) had resolved. At the time of the report, DEEP VEIN THROMBOSIS (Lump in vein), PAIN IN EXTREMITY (Woke up in extreme pain, wave of huge pain/extreme pain / pain was overwhelming./ Painful) and PERIPHERAL SWELLING (Badly swollen hand,Swollen/ swelling of right hand: from below last thumb joint to past wrist/ Swollen lump on surface vein below thumb/ swelling was too restrictive) had resolved and THROMBOSIS (blood clot on hand) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) mmHg. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. After second shot on 10-Jul-2021 patient experienced extreme pain, swelling of right hand: from below last thumb joint to past wrist. Swollen lump on surface vein below thumb, tender to touch, and warmer than surrounding skin, with red, purplish discoloration. On scale of 1 to 10, the pain level was a 10. Unable to turn wrist, swelling was too restrictive and pain was overwhelming. Unable to use hand. Over course of approximately 2 days the swelling died down and the pain lessened. The hard lump blood clot on the vein remains. Patient consulted Cardiologist. diagnosed it as Superficial Thrombophlebitis, informed to patient it was blood clot in the wall of a peripheral/surface vein caused by inflammation. cardiologist recommended for at-home treatment was: warm compresses, raising my arm above my heart as much as possible for at least 1-2 days, & using an anti-inflammatory NSAID like Aleve, etc. Patient indicated that he swelling and associated pain would most likely dissipate within a couple of days. He also stated the blood clot would take several months to improve/resolve. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-235384 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Significant follow up received and added Patient medical history, concomitants,NewAE ,vaccine details,causality and outcome details, and patient demographics are updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
72 2021-07-27 heart attack, oxygen saturation decreased Patient began feeling like she was having panic attacks. She was nauseous and went to the ER. ER ran... Read more
Patient began feeling like she was having panic attacks. She was nauseous and went to the ER. ER ran tests including Ct scan, ekg and blood work. All tests came back normal. A couple of hours later patient became delirious and oxygen started to drop. Then patient was intubated at which point she had a major heart attack and died.
72 2021-07-28 cerebral haemorrhage This is what happened after April 1st vaccine?within about 2 weeks I started having brain fog and fe... Read more
This is what happened after April 1st vaccine?within about 2 weeks I started having brain fog and feeling out of it, times with short term memory just not myself. Also, I was having tingling and numbing on my left side in my arm and leg. This has never subsided, it is continuous even now. I had to go to have Neurological Nerve testing at which has revealed I and having mild Gillian-Barrah. Also, my RA seems to worse and now I starting to have occasional tingling on my right side from time to time.
72 2021-07-28 low blood platelet count Approximately 13 hours after receiving dose 1 her platelet count fell; Exacerbation of preexisting I... Read more
Approximately 13 hours after receiving dose 1 her platelet count fell; Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Approximately 13 hours after receiving dose 1 her platelet count fell) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immune thrombocytopenia. Concomitant products included ELTROMBOPAG for Immune thrombocytopenia. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Approximately 13 hours after receiving dose 1 her platelet count fell) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses). The patient was treated with ELTROMBOPAG for Adverse event, at a dose of 50 milligram once a day and ELTROMBOPAG for Adverse event, at a dose of 75 milligram once a day. At the time of the report, IMMUNE THROMBOCYTOPENIA (Approximately 13 hours after receiving dose 1 her platelet count fell) and CONDITION AGGRAVATED (Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: 65-80 10^9/L (Inconclusive) before dose 1 of Moderna SARS-CoV-2 vaccine, 45 10^9/L (Low) Approximately 13 hours after receiving dose 1 of the Moderna SARS-CoV-2 vaccine platelet count fell to 45 x10^9/L.(42% decrease), 298 10^9/L (High) After eltrombopag dose was increased to 50 mg daily with an increase in platelet count to a peak of 298 x 3 10^9/L., 193 10^9/L (Inconclusive) Approximately 1 hour before receiving dose 2, the platelet count was 193 x 10^9/L and 205 10^9/L (High) In response to 3 doses, the platelet count increased to 205 x10^9/L. In 2021, SARS-CoV-2 antibody test: negative (Negative) Negative. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered IMMUNE THROMBOCYTOPENIA (Approximately 13 hours after receiving dose 1 her platelet count fell) and CONDITION AGGRAVATED (Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses) to be possibly related. It was reported that the eltrombopag daily dose was adjusted to compensate for dynamic platelet destruction. The platelet count fell to 42% with the first, consistent with a cumulative effect on the underlying humoral response. Although the patient has a history of chronic ITP, based on a strong relationship as the event is reported to have an onset latency of 13 hours after administration of mRNA-1273, a causal relationship between the product use and the event cannot be excluded. Some vaccines have been shown to be associated with both reactivation of immune mediated diseases such as immune thrombocytopenia purpura This case was linked to MOD-2021-263965, MOD-2021-263970, MOD-2021-264203 (Patient Link).; Sender's Comments: Although the patient has a history of chronic ITP, based on a strong relationship as the event is reported to have an onset latency of 13 hours after administration of mRNA-1273, a causal relationship between the product use and the event cannot be excluded. Some vaccines have been shown to be associated with both reactivation of immune mediated diseases such as immune thrombocytopenia purpura
72 2021-07-29 low blood platelet count The platelet count exhibited marked decrease after dose 2.; Exacerbation of preexisting ITP can sequ... Read more
The platelet count exhibited marked decrease after dose 2.; Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (The platelet count exhibited marked decrease after dose 2.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immune thrombocytopenia. Concomitant products included ELTROMBOPAG for Immune thrombocytopenia. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (The platelet count exhibited marked decrease after dose 2.) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses). The patient was treated with ELTROMBOPAG for Adverse event, at a dose of 50 milligram once a day and ELTROMBOPAG for Adverse event, at a dose of 75 milligram once a day. At the time of the report, IMMUNE THROMBOCYTOPENIA (The platelet count exhibited marked decrease after dose 2.) and CONDITION AGGRAVATED (Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: Three days after taking dose 2 of vaccine the platelet count fell to 27 x 10^9/L (86%decrease) prompting an increase in eltrombopag to 75 mg daily and 205 10^9/L (Inconclusive) In response to 3 doses of eltrombopag, the platelet count increased to 205 x 10^9/L. In 2021, SARS-CoV-2 antibody test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered IMMUNE THROMBOCYTOPENIA (The platelet count exhibited marked decrease after dose 2.) and CONDITION AGGRAVATED (Exacerbation of preexisting ITP can sequentially increase in severity with each of the 2 doses) to be possibly related. The eltrombopag daily dose was adjusted to compensate for dynamic platelet destruction This case was linked to MOD-2021-263889, MOD-2021-263965, MOD-2021-263970 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Chronic Immune Thrombocytopenia could be potentially confounders/co-suspects for the events.
73 2020-12-31 hypertension, heart rate increased Patient called and left voicemail she woke up during the night after her first COVID-19 Moderna vacc... Read more
Patient called and left voicemail she woke up during the night after her first COVID-19 Moderna vaccine with rapid heart rate 130bpm and high blood pressue, but did not elaborate what high blood pressure was. Said after that she has felt fine.
73 2021-01-07 loss of consciousness Okay first hours. Started feeling dizzy. Went to sleep, Woke up next morning went shopping, started ... Read more
Okay first hours. Started feeling dizzy. Went to sleep, Woke up next morning went shopping, started with dizziness again. On the way back home pulled into carport and bumped into the house. She sideswiped everything. Blacked out as she was backing into the driveway. Hit the house several times. She has no recollection of this. Totaled the car, house has to be repaired. Ribs are in pain from accident.
73 2021-01-08 fainting, blood pressure increased Patient fainted at 15 min mark after receiving vaccine. She was out for about 2 minutes. Her oxygen ... Read more
Patient fainted at 15 min mark after receiving vaccine. She was out for about 2 minutes. Her oxygen level dropped and blood pressure increase. Patient was given one dose of Nitro 0.4 mg SL and one tablet of Diphenhydramine 25 mg .
73 2021-01-12 hypertension Patient became dizzy, hypertensive (213/113), flushed, and nauseated post vaccination
73 2021-01-12 hypertension On 01/11/2021, within a few hours of my grandmother getting the shot her injection area became red, ... Read more
On 01/11/2021, within a few hours of my grandmother getting the shot her injection area became red, swollen and hot to the touch. At around midnight the day her shot she started to experience tingling on both sides of my tounge. She an unusually restless night and on 1/12/2021 woke up feeling very tired and over all worn down. Around 10:45a my I called to check on her she said she had just checked her temp and it was 99.6. She was complaining of being very cold and had the shivers. While on the phone she started to develop a stutter. At first it was one word every 14-20 word but it quickly got worse to the point where she couldn't get a full word out and just sounds. I immediately left work and went to her house. On my way we contacted 911. It took me about 10 mins to get to her house and when I got there she was semi- unresponsive on the couch making moaning noises and shaking. She was having severe muscle spasms throughout her body. You could see her muscles tighten and release. EMS got there within a few minutes after me. They checked her temp and it had increased to 101.00 she was a bit responsive and they were able to take her vitals however, it was difficult due to her shaking and convulsing. They transported her to the hospital and by they time they arrived (within 15 mins) her temp was then 102.6. She was still shaking, not lucid and stuttering her words. They hospital ran several tests to rule out stroke and other possible reasons for her symptoms- they said she had to be having a delayed reaction to the shot. She was extremely dehydrated, they hooked her up to an IV, she had an extremely elevated white blood count and was overall "out of it". She was given IV antibiotics and observed.
73 2021-01-13 fainting Pt collapsed at home approx 5:30 pm and died
73 2021-01-17 loss of consciousness 24 hours after vaccine: tiredness weakness, chills, fever, nausea, vomiting, fainted, unconscious fe... Read more
24 hours after vaccine: tiredness weakness, chills, fever, nausea, vomiting, fainted, unconscious few seconds. No medical treatment, resting at home,
73 2021-01-19 heart rate increased, blood pressure increased In 14 minutes facial cheeks,nose, lips tingling and num accompanied with dizziness-nurses evaluated ... Read more
In 14 minutes facial cheeks,nose, lips tingling and num accompanied with dizziness-nurses evaluated with elevated blood pressure and very high heart rate-EMTS also evaluated & said I could go to hospital for observation but I refused. I remained for hour with unchanged symptoms-left took a Benadryl and it helped with tingling. For remaining 36 hours was short of breath and difficulty swallowing. Continued on Benydril for 2 days-olater symptoms were side effects fatigue headache, joint pain, chills, tenderness at injection but mild
73 2021-01-20 fast heart rate started severe nausea, 15 minutes, ice cold, shaking, chills, lasted 30 minutes, felt Shortness of b... Read more
started severe nausea, 15 minutes, ice cold, shaking, chills, lasted 30 minutes, felt Shortness of breath, arm pain, tachycardia, 1 hour total before felt better. Overnight had night sweats, fever, fatigued, no wheezing, no meds taken by the morning felt back to normal.
73 2021-01-21 cerebrovascular accident Patient suffered stroke morning after vaccine.
73 2021-01-21 fainting Pt had Moderna Vaccine. Pt verbalized lip tingling sensation, followed by throat swelling and faint... Read more
Pt had Moderna Vaccine. Pt verbalized lip tingling sensation, followed by throat swelling and fainting and grunting with inspiration. Was not able to obtain BP at the time. Epinephrine 0.1 mcg x 2 was given 3-5 minutes apart. Pt responded well. Was alert, and verbally responsive. Pt also received Benadryl 50 mg IM, Famotidine 20 mg, and Solumedrol 40 mg. Pt was taken by Paramedics to Emergency department for continued management. Pt was advised to not take second dose of Moderna Vaccine.
73 2021-01-22 loss of consciousness 8pm tried to get up out of the bathtub, called husband he helped me to the toilet and i passed out. ... Read more
8pm tried to get up out of the bathtub, called husband he helped me to the toilet and i passed out. He helped me up and I vomited twice. Very crazy experience, I never had something happen to me like that. I only received one regular flu shot in my life no other shots.
73 2021-01-24 blood pressure increased Tingling and burning in upper body and elevated blood pressure.
73 2021-01-24 chest discomfort, chest pain allergic reaction. tongue swelling within couple minutes, tightness in chest, lungs tight, burning i... Read more
allergic reaction. tongue swelling within couple minutes, tightness in chest, lungs tight, burning in chest lasted 10 minutes, subsided after a while. wanted to report what she had, concerned with second and if she should take Benadryl
73 2021-01-25 heart rate increased, blood pressure increased Moderna Covid-19 Vaccine EUA Extremely elevated blood pressure and heart rate. Given Benedryl and St... Read more
Moderna Covid-19 Vaccine EUA Extremely elevated blood pressure and heart rate. Given Benedryl and Steroid shots. Symptons continued into third day. Prescribed Metaprolol.Gradually improving.
73 2021-01-25 pulmonary embolism, deep vein blood clot Had normal side effects the day after, 12/25/20 slight fever, lethargy, not even sore arm. on the 27... Read more
Had normal side effects the day after, 12/25/20 slight fever, lethargy, not even sore arm. on the 27th, felt fine. On 12/28/20, woke up not able to breath, oxygen saturation 83%, could not walk across the room without gasping for air, which lasted for about 2 days. Could not reach her PCP due to holidays, was convinced she had COVID. Went to drive-thru facility and got the COVID test on 12/28/20, negative on 12/29/20. Then made another APT, went back on 12/30/20 had negative test again. On 12/30/20 started feeling better, was not great but her 02 SAT's were about 90. Stayed that way until 1/8/21, had FU from lumpectomy with surgeon, when she got up her left ankle/foot were very swollen and red looking. Saw that Dr., and discussed the postop business and showed her the foot/leg told her to have it looked at. Her PCP was closed, she went to radiology Dept in Hospital and found DVT in her left leg. She was then told to go to the ER and ordered a CT scan, which showed pulmonary emboli in both lungs. Put on heparin IV right away, later transferred to another hospital where CV surgeon on staff. By that evening they decided that she was walking , talking and checking blood levels, kept her overnight and sent her home the next day. Needed to be on blood thinners, and saw pulmonologist. Has APT with hematologist this week. Pulm told her to call and report adverse reaction. Today, 1/26/21 her 02 SAT's are in the 99%, leg is still swollen, and is able to breath better. On Eliquis which will prevent new clots, but the others should be absorbed. Got 2nd dose on 1/21/21 and had only the classic side-effects for about 30 hours but was then fine. Had fever, chills, nausea, sore arm, cough, but then was fine. Same lot # as dose 2.
73 2021-01-26 atrial fibrillation, fast heart rate Atrial Fibrillation; Tachycardia (Double heart rate); A spontaneous report was received from a 73-ye... Read more
Atrial Fibrillation; Tachycardia (Double heart rate); A spontaneous report was received from a 73-year-old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced atrial fibrillation and tachycardia. The patient's medical history was not provided No relevant concomitant medications were reported. On 09 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10 Jan 2021, the patient reported having atrial fibrillation and tachycardia. Treatment for the events included metoprolol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, atrial fibrillation and tachycardia, were considered not resolved.; Reporter's Comments: This case concerns a 73-year-old, female patient. The patient's medical history was not provided. The patient experienced an unexpected event of Atrial fibrillation and tachycardia. The event occurred 2 days after the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
73 2021-01-26 fainting Injection site pain, Nausea, light headed same day (1/25//2021) after injection. That evening, Nause... Read more
Injection site pain, Nausea, light headed same day (1/25//2021) after injection. That evening, Nausea, fever and chills. Took Tylenol. Next day (1/26/2021) Nausea, fever and chills continued. On 1/27/2021 in the morning became faint and weak and fell or fainted. Due to fall hit her head. Daughter living in same house treated her with Ice Pack and brought her to Hospital ER for evaluation. Hospital identified fever and began antibiotic treatment and fluids.
73 2021-01-27 blood pressure increased bp spiked to 160/100
73 2021-01-30 haemoglobin decreased Severe abdominal pain and diarrhea accompanied by Lower gastrointestinal bleeding resulting in drop... Read more
Severe abdominal pain and diarrhea accompanied by Lower gastrointestinal bleeding resulting in drop of hemoglobin almost 3 grams. Treatment and tests at Presbyterian, University of Pennsylvania Emergency Department 1/19/2021. Discharged to home after 12 hours. Back to normal bowel function on 1/29/21
73 2021-01-30 heart rate decreased Chills, Fever (100.8), nausea, headache, difficulty breathing, extreme fatigue, joint and back pain ... Read more
Chills, Fever (100.8), nausea, headache, difficulty breathing, extreme fatigue, joint and back pain (the next day and 1/2 had to walk with a cane, pulse dropped to 46, Friday the injection site was red and itchy down to almost my elbow. I called the health department to report the symptoms but took no further action. Am slowly recovering. I did email my Cogan's specialist.
73 2021-01-31 troponin increased, cerebral haemorrhage This is a 73 year old female that received her 1st dose with Moderna vaccine on 1/8/21 at approximat... Read more
This is a 73 year old female that received her 1st dose with Moderna vaccine on 1/8/21 at approximately 1600. Within one hour, the patient developed altered mental status and increasing weakness. She was transported to the hospital by the staff at her Assisted Living Facility for concern of a vaccine reaction. On admission, oxygen saturation was found to be 89% on room air, BP=137/86, HR=94. Labs were normal, with the exception of WBC=15 (leukocytes normal, chest xray clear, COVID test negative), and a detectable troponin=63. Head CT negative. Physical exam was only notable for 'slight superficial erythema over distal right forearm and dorsal hand. No significant edema.' The patient was treated for a possible allergic reaction to vaccine with NS bolus, methylprednisolone 125mg, famotidine 20mg, and aspirin 300mg PR. She was admitted for monitoring given continued altered mental status/weakness. The next day, she continued to show no improvement, so a head MRI was ordered. MRI showed " 1. Numerous acute cerebral and cerebellar infarcts involving both anterior and posterior circulations consistent with a central embolic source. 2. Minimal right parietal petechial hemorrhage. 3. Moderate atrophy and moderate nonspecific white matter signal abnormalities compatible with chronic microvascular ischemia " Neurology was consulted, who approved the start of aspirin and to continue DVT prophylaxis. The patient's advanced dementia and timeline preclude other intervention. The patient's status was DNR/DNI. The patient was discharged on hospice to her assisted living facility on 1/11/21 (with reports of continued somnolence). It was reported that date of death was 1/24/21.
73 2021-02-01 cardiac failure congestive Acute kidney injury; CHF (congestive heart failure); COVID-19 virus infection; Chronic hepatitis C w... Read more
Acute kidney injury; CHF (congestive heart failure); COVID-19 virus infection; Chronic hepatitis C without hepatic coma; Edema leg; Essential hypertension
73 2021-02-02 heart attack, cardiac failure congestive, chest pain Received vaccine at 1100 on 1/29/21. No symptoms noted during 30 minute post-vaccine observation per... Read more
Received vaccine at 1100 on 1/29/21. No symptoms noted during 30 minute post-vaccine observation period. Symptom onset at 0300 on 1/30/21 (16 hours after vaccine administration). Symptoms included chest pain, dyspnea on exertion, weakness, nausea/vomiting, decreased appetite, and diarrhea. Patient presented to Medical Center Emergency Department around 1130 on 2/1/21. Found to have NSTEMI 2/2 Takotsubo's cardiomyopathy with acute congestive heart failure. (of note, coronary angiography in 11/20 showed no coronary artery disease). Patient has never had a reaction to a vaccine or component despite receiving many vaccines due to extensive travel history.
73 2021-02-03 heart rate increased, blood pressure increased, chest discomfort Within 5 minutes of vaccine patient complained of chest tightness and headache. Evaluated by EMS - ... Read more
Within 5 minutes of vaccine patient complained of chest tightness and headache. Evaluated by EMS - elevated blood pressure and heart rate. Patient transported by EMS to Sentara Albemarle Medical Center ER. Patient evaluated for several hours in the ER then sent home.
73 2021-02-03 heart rate increased, chest pain, blood pressure increased Received vaccine at 4 pm. At 6 PM, I started having pain from shoulder to shoulder. Then pulse start... Read more
Received vaccine at 4 pm. At 6 PM, I started having pain from shoulder to shoulder. Then pulse started to rise and by 6:30 pm, I had central chest pain and my pulse was 107. Blood pressure rose. I kept checking it and by 9 pm, it had slowed to 97. I contacted my doctor who told me to monitor it and call back. She checked with me on Feb. 4th and my blood pressure and pulse continue to go down slowly.
73 2021-02-03 palpitations patient c/o heart racing that lasted about 3 mins in duration. administered a total of 50mg of IM Be... Read more
patient c/o heart racing that lasted about 3 mins in duration. administered a total of 50mg of IM Benadryl. after 10 minutes, patients heart rate went from 142bpm to 74 bpm.
73 2021-02-05 chest discomfort 30 minutes post injection-weakness, face flushed, felt minor chest constriction, lips swelled and to... Read more
30 minutes post injection-weakness, face flushed, felt minor chest constriction, lips swelled and tongue tingled. I didn't inform the observers because I felt I could handle this myself. I drank water and rested another 10 minutes until the weakness dissipated. However, the chest tightness and tongue redness and tingling continued so I contacted my primary physician who recommended Claritin or Zyrtec which I took. Most reactions have dissipated but swollen reddened tip of tongue and tingling persist - second day.
73 2021-02-05 chest discomfort About 20 minutes after receiving the shot, I started feeling uneasy. Realized that my fingers were ... Read more
About 20 minutes after receiving the shot, I started feeling uneasy. Realized that my fingers were getting tight with swelling. I could feet the sides of my chests getting tight - felt like pressures were building up with swelling. I did not have problems with breathing. About 10 minutes later I could feel my lips swelling, but stopped after about 10 minutes. In the evening, felt nausea. Did not feel well for two days. Got a little better on the third day but not completely well. Completely recovered on the fourth day. Should I get the second shot? I am afraid it might be worse on the second shot if what I was feeling were due to allergy.
73 2021-02-07 blood pressure increased Fever went up slowly, spiked at 103, then went down, sleepiness, blood pressure went up, similar sym... Read more
Fever went up slowly, spiked at 103, then went down, sleepiness, blood pressure went up, similar symptoms to when I had COVID, except did not have heightened taste, neither time did I have trouble breathing, Cough, swollen red arm. Just rested and watched if had trouble breathing
73 2021-02-07 heart rate increased Left arm started aching and turning red and has continued all these 10 days; now it is itchy and has... Read more
Left arm started aching and turning red and has continued all these 10 days; now it is itchy and has spread across the arm; also other symptoms were fast heart beat, aching terribly with body aches x 10 days also with headache x 10 days
73 2021-02-07 hypotension, heart rate increased 24 hours after injection - low blood pressure (90 over 68) rapid heart rate - 110 to 115 for approxi... Read more
24 hours after injection - low blood pressure (90 over 68) rapid heart rate - 110 to 115 for approximately 4-5 hours
73 2021-02-08 heart rate increased Heart rate went up close to 150 bpm
73 2021-02-08 heart rate increased Moderna COVID-19 Vacine EUA Rapid heartbeat 20-25 minutes after injection. Reached 112 pulse rate. ... Read more
Moderna COVID-19 Vacine EUA Rapid heartbeat 20-25 minutes after injection. Reached 112 pulse rate. The attending nurse monitored me for about 20 minutes taking my blood pressure at least 3 times. We even compared pulse-oximeter reading to be sure my meter was not false. Pulse came down to 89 - normal-ish. I left under my own power minutes later.
73 2021-02-09 cardiac arrest the following morning the patient became unresponsive while taking a shower, became asystolic and di... Read more
the following morning the patient became unresponsive while taking a shower, became asystolic and died despite about an hour of ACLS and 8 rounds of epi
73 2021-02-10 blood pressure increased, heart rate increased Patient reported she began to feel bad on her way home after receiving the vaccine (she had waited a... Read more
Patient reported she began to feel bad on her way home after receiving the vaccine (she had waited at the clinic for 15 minutes after receiving the vaccine and felt fine at the clinic). She reported she began to have a rapid heart rate (which went away that evening) and elevated blood pressure. She normally takes a BP med and took an extra 1/2 pill that evening. Her BP was up to 178/101 and came down to 124/78. She reports she is still not feeling well (but BP is within her normal range). She reports she will contact her PCP. I advised her to go to the urgent care and she wants to wait to see her PCP. She agrees to go to urgent care or ER if condition worsens.
73 2021-02-10 chest discomfort Patient received COVID vaccine at approximately 1630. Patient verbalized shortness of breath and tig... Read more
Patient received COVID vaccine at approximately 1630. Patient verbalized shortness of breath and tightness in chest at approximately 1637. 911 was called. Responders arrived within 3 minutes of placing the call. Responders took the patient to a local emergency department.
73 2021-02-10 heart rate increased About 3:30 in the morning I woke up and I was really cold. I started having chills. when I checked m... Read more
About 3:30 in the morning I woke up and I was really cold. I started having chills. when I checked my temperature it was in the 99s (the highest my temperature 101.9. When I checked my heart rate in the morning and it was in the 90s, and that's higher than normal for first thing in the morning. My heart rate went high and I had achy muscles. I sat around all day, but I didn't feel that bad in the morning, I took an extra strength Tylenol and I didn't have much have an appetite. My heart rate stayed in the 90s-130, so I called my cardiologist and he recommended I alternate Tylenol and ibuprofen and drink lots of fluids. By dinner that night I had no appetite, and then I had nausea and dry heaves, so I took 25 mg of promethazine at about 8 and the dry heaves got better within an hour. I got the COVID tongue. I had a white coating on my tongue and I couldn't get it off and a weird metallic taste in my mouth, I had a mild headache. The next day I felt much better. I called my PCP and they didn't think it was necessary for me to come in for a cardiogram because I was feeling better.
73 2021-02-10 loss of consciousness, fainting Syncope and collapse. 10 minutes after injection, while sitting, I got very dizzy and hot. Appare... Read more
Syncope and collapse. 10 minutes after injection, while sitting, I got very dizzy and hot. Apparently I passed out and had to be given two nose sniffs with ammonia to get me awake. Was told by nurse that she had to rub my sternum to get me awake. This lasted a few minutes after which I was clammy all over, but feeling better.
73 2021-02-12 increased heart rate, blood pressure increased, palpitations Pt reported having palpitations after receiving the first dose of COVID vaccine. Pt states she began... Read more
Pt reported having palpitations after receiving the first dose of COVID vaccine. Pt states she began feeling a little light headed. Pt was taken to the triage area and assessed by EMS and this ED Nurse. There were no s/s of anaphylaxis. 4 lead cardiac monitor was placed by EMS. Sinus tachycardia was noted with at rate of 117. Blood pressure was 191/125. Spo2 was 100% without oxygen supplementation. Repeat blood pressure was 202/92 with a heart rate of 104. Pt remained in the observation area for 30 minutes. Pt declined staff and EMS request for hospital transport. Pt left observation area ambulatory with friend who agreed to stay with the patient and assist her home. Pt was instructed to call 911 for any worsening of symptoms or cause for concern. Patient agreed.
73 2021-02-13 fainting, blood pressure decreased Day of vaccine headache, fatigue, soreness 2nd day 2/13/21 Had issues sleeping and felt uncomforta... Read more
Day of vaccine headache, fatigue, soreness 2nd day 2/13/21 Had issues sleeping and felt uncomfortable. In early a.m. hours, felt dizzy, feeling of sick stomach, and fainted in the bathroom. Paramedics were called by my spouse and they worked with me, then was transported by Ambulance to emergency room where they ran tests and released me the same day. I was told by the doctor that apparently my blood pressure decreased too fast causing me to faint.
73 2021-02-14 heart rate increased, chest discomfort Received vaccination at 10:36 am Saturday, 2/13/21. At approx. 9:15 pm began with headache, then ,ra... Read more
Received vaccination at 10:36 am Saturday, 2/13/21. At approx. 9:15 pm began with headache, then ,rapid heartbeat...agitated thoughts; fears there were ''things in my room or on me'' ...chest tight to breathe. Chills.;did not sleep well. Sunday Next day, 2/14/....beginning 6am......awoke with body aches , joint pain, headache continued., weakness in limbs, extremely tired. Afternoon of 2/14/21...began runny nose, violent repeating sneezing spells ...chills ..By 5 pm on Sunday 2/14 symptoms were subsiding...slept better. Today 2/15 much resolved except for runny nose and some sneezing . No Fever was ever present.
73 2021-02-14 heart rate increased Elevated heart rate (HR got up to 118 bpm). We got her water and had her sit and take some deep brea... Read more
Elevated heart rate (HR got up to 118 bpm). We got her water and had her sit and take some deep breaths. We monitored her HR for 2.5 hours. Over that time it gradually went down, it never spiked back up--118bpm, 97bmp, 96bpm, 90bp, 90bpm, 90bp, 80bpm, 82bpm, 82bpm. (For reference, her resting HR is around 77 per patient)
73 2021-02-15 loss of consciousness, heart rate increased Heart rate at 107; Stomach issue; Nausea; Chills; Passed out; Dizzy; Temperature; Hands were shaking... Read more
Heart rate at 107; Stomach issue; Nausea; Chills; Passed out; Dizzy; Temperature; Hands were shaking; Sweating profusely; A spontaneous report was received from a consumer who is a 73 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, dizzy(dizziness), temperature(temperature abnormal), hands were shaking(tremors), passed out(loss of consciousness), sweating profusely(hyperhidrosis), nausea, heart rate at 107(heart rate increased) and stomach discomfort(abdominal discomfort). The patient's medical history, as provided by the reporter included breast cancer. No concomitant medications were reported. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient experienced chills, dizzy, temperature, hands were shaking, passed out and sweating profusely. The treatment for the events included paracetamol. On an unknown date, the patient experienced, nausea, heart rate at 107 heartbeats per minute and stomach discomfort. The treatment for the events included paracetamol. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, chills, dizzy, temperature, hands were shaking, passed out, sweating profusely, nausea, heart rate at 107 and stomach discomfort was unknown.; Reporter's Comments: This case concerns a 73-year-old female patient, who experienced serious event of loss of consciousness and non-serious events of chills, dizziness, temperature abnormal, tremors, hyperhidrosis, nausea, heart rate increased, and abdominal discomfort. The reported events occurred on the same day after first dose of mRNA-1273, (lot # 029L20A) with the exception of nausea, heart rate increased, and abdominal discomfort which occurred at unknown date. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
73 2021-02-17 oxygen saturation decreased, deep vein blood clot, pulmonary embolism Sadle embolism in lungs; DVT in left leg; Slight fever; Extreme fatigue; Shortness of breath,struggl... Read more
Sadle embolism in lungs; DVT in left leg; Slight fever; Extreme fatigue; Shortness of breath,struggling for every breath; Low o2 sat; A spontaneous report was received from a health care professional, who was a 73-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced shortness of breath, slight fever, extreme fatigue, left leg deep vein thrombosis (DVT), and saddle pulmonary embolism (PE). The patients' medical history was not provided. No concomitant medications list was provided. On 24 Dec 2020, prior to the onset of symptoms, patient received the first of two planned doses of mRNA-1273 (Batch number 011J20A) for the prophylaxis of COVID -19 infection. On 25 Dec 2020, patient experienced shortness of breath with low oxygen saturation levels. On 26 Dec 2020, the patient's oxygen saturation levels were down to 89% with slight fever and extreme fatigue. On 27 Dec 2020, patient's energy was back to normal. On 28 Dec 2020, the patient woke up in the morning with symptoms of almost could not breathe, could not walk across the room. The patient's vital signs included oxygen saturation 83%. The patient was struggling for every breath. The patient tested negative for COVID-19. On 30 Dec 2020, another COVID-19 test was negative. On 31 Dec 2020, patient's vital signs included oxygen saturation closer to 90%, and she reported getting better. Symptoms remained the same for about a week. On 08 Jan 2021, the patient experienced left ankle and foot swollen. The patient was seen by physician and then sent to emergency room where it was determined that the patient had DVT in the left leg. A computerized tomogram (CT) scan found clots in the left lung, or saddle PE. On 09 Jan 2021, the patient was discharged from the hospital. Treatment for the events experienced included intravenous heparin and blood thinners. Action taken with planned second dose of mRNA-1273 in response to the events was not provided. The event, extreme fatigue, was considered resolved on 27 Dec 2020. The outcome of the events, shortness of breath, slight fever, DVT and saddle PE were not provided. Follow-up received on 19 Jan 2021 included updated events (DVT and saddle PE), updated event details, treatment, and hospitalization details.; Reporter's Comments: This spontaneous report refers to a case of 73- year-old female patient who experienced serious event of pulmonary embolism and deep vein thrombosis and non-serious events of shortness of breath, oxygen saturation levels were down to 89% with slight fever and extreme fatigue the next day after administration of the first dose of mRNA-1273, lot # 011J20A, expiration date-unknown. Based on temporal information provided and the known safety profile of the vaccine and the absence of any other etiology factors, a causal association between the vents of shortness of breath, oxygen saturation levels were down to 89% with slight fever and extreme fatigue and the administration of mRNA-1273 vaccine cannot be excluded. Fever and fatigue are consistent with the known safety profile of mRNA-1273 vaccine. There is no enough information t clinically assess the causal association between the events of pulmonary embolism and deep vein thrombosis as the patient's medical history and list of concomitant medications were lacking. Main field defaults to ‘possibly related'
73 2021-02-19 oxygen saturation decreased Asa result of dizziness the patient fell unwitnessed. Resident was sent to the ER with low O2 Satura... Read more
Asa result of dizziness the patient fell unwitnessed. Resident was sent to the ER with low O2 Saturation <90
73 2021-02-21 chest discomfort Immediate neck pain growing into severe headache including teeth pain, difficult thinking. Ingeste... Read more
Immediate neck pain growing into severe headache including teeth pain, difficult thinking. Ingested naproxem sodium 500 mg. tablets...two times a day for 2 days. Tight chest with heaviness and shortness of breath, started within 30 minutes and grew more difficulty breathing over each ensuing hour. Ventolin inhaler and Wyxlela inhaler s used 4 times over recommeded dosage....to no avail. Used nebulizer with Ipratropium Bromide an Albuterol Sulfate..two times over 3 hours. This medication was a year expired . This asthma attack was from 2:15 p.m. to 9 p.m. on 2/15/21. On 2/22/ little relief with severe headache. On 2/23 was exhausted from the 2 day ordeal. The asthma is the most concerning, as I do not know how severe asthma attack maybe. It could be emergency care or life threatening. I do not know whether to check life threatening box below.
73 2021-02-21 haemoglobin decreased, fainting, platelet count decreased Admitted withy syncope and began to have pancytopenia
73 2021-02-21 palpitations Chills,headache, dizziness and weakness, palpitations
73 2021-02-22 chest pain epigastric and chest pain, went to emergency room
73 2021-02-22 heart rate increased very rapid heart rate for 45 minutes 6 hours after vaccine
73 2021-02-22 loss of consciousness Patient states she woke up at her usual time and on the way to the kitchen blacked out. She woke up... Read more
Patient states she woke up at her usual time and on the way to the kitchen blacked out. She woke up and crawled to the kitchen then blacked out and and peed herself.
73 2021-02-23 pulmonary embolism, fibrin d dimer increased Moderna COVID-19 Vaccine: The morning after injection, she developed shortness of breath, fever, mus... Read more
Moderna COVID-19 Vaccine: The morning after injection, she developed shortness of breath, fever, muscle pains, joint pains, delirium. 911 called. EMTs transported her to Hospital where she was admitted after blood tests and CT angiogram of the chest indicated multiple pulmonary emboli in right upper and lower lobes of the lung. Unconscious at the time of admission. Discharged after 3 days. Continues to have significant shortness of breath. Unknown if this will be permanent or lead to death. Reasonably stable at present time although unable to function.
73 2021-02-23 fainting Syncope, BP 88/67, P 59, R 20, Was assisted to chair, given apple juice, crackers, water VS after ... Read more
Syncope, BP 88/67, P 59, R 20, Was assisted to chair, given apple juice, crackers, water VS after 15 minutes: BP 124/74, P 111, R 18, VS after 30 minutes 121/93, P 101, R 18
73 2021-02-24 cardiac failure congestive, low blood oxigenation Patient received Moderna Vaccine on 2/20/21 at pharmacy. She has a history of atrial fibrilation and... Read more
Patient received Moderna Vaccine on 2/20/21 at pharmacy. She has a history of atrial fibrilation and diastolic heart failure. On 2/23/21 she presented to ED with symptoms of SOB, hypoxia and cough with findings of fluid overload likely due to exacerbation of diastolic heart failure. Also reports of tongue swelling per ED provider (was not witnessed by me) for which she received IM epinepherine, solumedrol, and decadron. She is currently receiving IV diuresis with improvement of high flow nasal canula requirements
73 2021-02-25 chest discomfort About 3 or 4 hours after vaccine, I developed tightness in my chest and shortness of breath. I felt... Read more
About 3 or 4 hours after vaccine, I developed tightness in my chest and shortness of breath. I felt like I did when at high altitude. When climbed basement stairs (10 stairs), had to stop at top and take deep breaths. While sitting or laying down, felt needed to take deep breath. Felt breathing was shallow. Tightness in chest went away next day. Shortness of breath went away on evening of day 5.
73 2021-02-25 fainting, blood pressure increased, hypertension, chest discomfort 16 hours after administration had a syncopal event lasting 5 minutes. Occasional tingling in both f... Read more
16 hours after administration had a syncopal event lasting 5 minutes. Occasional tingling in both feet, both hands, and jawline. Woke up in the middle of the night 2/23/21 and 2/25/21 with sensation of ball rolling in chest. Noticed high blood pressure on 2/26/21 ranging 130-163/80-86.
73 2021-02-26 hypertension, blood pressure increased I am not 100% certain of this event being related to the vaccination with the Moderna COVID19 shot o... Read more
I am not 100% certain of this event being related to the vaccination with the Moderna COVID19 shot or not. However, in the interest of completeness and for investigative purposes, I am reporting to you the event in relation to the vaccination as the patient reported to me. She received the vaccination on 2/14/2021 and became very confused. She had significant left arm swelling much worse than when she had her first vaccination. Her husband brought her to the emergency room and she was eventually discharged, but she went on to develop significant hypertension and she reported that her blood pressures were normal prior to the vaccination. She had an emergency room visit in which her systolic pressures were well above 240. She revisited the emergency room and had elevated blood pressures of 240 and was diagnosed with hypertensive encephalopathy and later found to have posterior reversible encephalopathy syndrome or PRES. We have started the patient on medications, and started laboratory work-up for secondary hypertension and her blood pressures have improved with treatment. We discussed the case with the neurologist, who suggested that we repeat MRI scan to make sure that her punctate lesions noted on MRI on this admission on 2/25/2021, have resolved. It was advised that if they had not resolved that we should call neurology again. Hypertensive encephalopathy is rare and press syndrome as a result is also rare. It is for this reason that I am reporting this event as again, I am not trying to mislead anyone or distort information, but should this be an adverse effect of the vaccine I wanted to make sure that this was reported as the patient's history prior to the vaccination and developing this complication post vaccination are temporally related at a minimum. The patient is a known smoker but quit on the 14th of this month.
73 2021-02-26 hypertension, chest discomfort Rheumatoid arthritis H.Blood pressure, Thyriod problem nember went from 2 to 20 2.17.202arrived... Read more
Rheumatoid arthritis H.Blood pressure, Thyriod problem nember went from 2 to 20 2.17.202arrived at dr. office for routine dr. visit BP taken 182/112 1 hr after injection. BP never this high, 2.18.202 Bp very high all day 170/105 sore neck, back head ache body ache, general feel weak ill 2=19-2021 BP very high chest discomfort gettin worst Went to Hospital E>R> BP 200/115 all time in E>R> high did cat scan, truck body, 2EKG in / out , Mutiple blood test. heart test echo gram discharged upped bp med to 37.5 from 25 mg in am 25 mg in evening BP still high chest pressure, 170/100s 2-20 bp still hig 170.100's chest discomfort near heart left arm necj k pain can't hardly move neck 2.21 got up am bp 96.69 back to dr. 124.70.s 2.22 118/70 chest pressure neck pain arm pain very uncomfortable Whole time no sleeping NO B.M.'s
73 2021-02-26 palpitations Onset of: Moderate to severe chills; moderate to severe malaise; mild palpitations; one d... Read more
Onset of: Moderate to severe chills; moderate to severe malaise; mild palpitations; one day of not being able to move around house. Got shot on a Wednesday; felt improved by following Friday.
73 2021-02-27 heart rate increased One day after the vaccine, I awoke with a headache & body aches. Later that afternoon, I had a feve... Read more
One day after the vaccine, I awoke with a headache & body aches. Later that afternoon, I had a fever of 101.4 and chills. The next day, I had an elevated heart rate and dizziness. I had several more episodes of a rapid heart rate that day. I called my cardiologist's office and they advised me to start on propranolol 20mg twice daily. They had prescribed that earlier as I have had episodes of that in the past but did not take the medication. After the 3 doses, approximately 12 hours apart, the lightheadedness and dizziness got worse. I called the cardiologist on call and they d/cd the med. Today, the lightheadedness & dizziness is worse.
73 2021-02-28 chest discomfort While working only an hour at my normal job not doing anything unusual or extraordinary, it became i... Read more
While working only an hour at my normal job not doing anything unusual or extraordinary, it became increasingly difficult to breathe. Chest felt very heavy and I became lethargic, not able to take a deep breath. Left work and became a couch potato the rest of the day and evening. Today symptoms about the same. Breathing still a problem and although it does not feel good, I am forcing myself to take an occastional deep breath. Did not report to work.
73 2021-02-28 loss of consciousness Awakened at about 5 am , approximately 18 hours after the injection. Got out of bed to go to the ba... Read more
Awakened at about 5 am , approximately 18 hours after the injection. Got out of bed to go to the bathroom and passed out. I am not sure how long I was unconscious,. but when I came to I was on the floor and unable to move. I called out to my husband and he got me up, but I could not walk. He got me back into bed. Several hours later he assisted me in walking and I am walking ok now.
73 2021-02-28 pallor On 3/1/21, about 10 AM, I found a new pink oval spot on Left deltoid, about 2 1/2 in tall, 2 in wide... Read more
On 3/1/21, about 10 AM, I found a new pink oval spot on Left deltoid, about 2 1/2 in tall, 2 in wide. Pink color, firm and slightly warm, mildly tender, some rash spots above it. Edges not raised. Blanched in center with pressure. Exactly 2 weeks after 1st dose Moderna vaccine. No systemic symptoms at this time. Prior to this: On the day following 1st dose, the injection site became tender and sore, no change in skin color then, but some induration and was particularly sore when I raised my arm above my head. That Lasted about 3 days, and has been completely resolved. On the 3rd and 4th day post vaccination, I had mild fatigue and napped each of those days (very unusual for me). Otherwise I have had nothing else from vaccination. I took picture this morning, but do not know how to attach it.
73 2021-02-28 pallor Pt stopped responding and looked pale at first site. Patient was clammy, and shaking. Patient c/o na... Read more
Pt stopped responding and looked pale at first site. Patient was clammy, and shaking. Patient c/o nausea and feeling lethargic, visual changes- "everything is yellow".
73 2021-03-01 fainting Weakness, headache, dizziness, fainting
73 2021-03-03 chest pain About 12 hours after vaccine she felt like she had COVID all over again. She had fever of 101, and ... Read more
About 12 hours after vaccine she felt like she had COVID all over again. She had fever of 101, and then the body aches that were very painful. She took Tylenol #3 for the pain and didn't notice the arm hurting yet. The main thing was the body aches and fever. She had chills off and on and a headache. She felt like she just couldn't get up, wiped out. She did not eat or drink much. Through the day Saturday and by Sunday the body aches left, the chills went down during the day but returned Sunday night 2/28/21. On 3/1/21 she went to the doctor and her temp was down, and is down now 3/4/21. Through the night Sunday night started having terrible pain in her chest/esophagus, which she could not get the pain to go away. She did the remedy that she read online, and has had some GERD over the years, but nothing like this. She could hardly even swallow her own saliva without pain. She got a prescription for Nexium from the doctor, and started taking that today. She is trying to eat something, little bity bits to go down without pain in her esophagus. The pain does get better at times during the day. She read that it may take 2-3 weeks to heal and the Nexium should be working by then. She is very fatigued and dealing with the acid reflux issues. She did also notice redness on her arm was about 3" x 2" down her arm. It was not at the site of the injection, was a little lower and it was hot to touch. She kept putting a cold washcloth on it. She took regular Tylenol. The body aches went away but was left with such a heavy headache that she took up to 4 Tylenol #4 due to pain. The redness had faded to about a square " by the time she went to the doctor on Monday, and is still really sore.
73 2021-03-03 heart rate increased, blood pressure increased At 12:30 a.m. on March 3rd I began having severe shivering for about 3 1/2 hours. This caused my blo... Read more
At 12:30 a.m. on March 3rd I began having severe shivering for about 3 1/2 hours. This caused my blood pressure to go up to 175/99, pulse 128. I also began running a fever at about that time and ran it for about 24 hours, highest is got was 101 . Arm is swollen. I had covid the first week of October so am not sure if this played into my reaction. I am concerned about taking my second shot if this is what I experienced with my first one.
73 2021-03-03 oxygen saturation decreased, pulmonary embolism Moderna COVID-19 Vaccine EUA 2/27/21: Pt received 1st Moderna vaccine 2/4/2021. She states that her... Read more
Moderna COVID-19 Vaccine EUA 2/27/21: Pt received 1st Moderna vaccine 2/4/2021. She states that her symptoms 1st started out as a slight postnasal drip, which turned into a hoarse voice with a cough, which turned into a head cold, which has turned in due shortness of breath, diarrhea, and cough with associated chills. After 17 days of cold-like symptoms, pt was tested on 2/26 for COVID and tested positive. 2/27, pt worsened and presented to ED. Upon arrival to the emergency department, the patient's temperature is 100.2° F, heart rate 96, respiratory rate 24, saturating 84% on room air with blood pressure 164/84. The patient's laboratory studies were significant for BUN 17, CR 1.47, lactate 2.2, D-dimer 6.79, and phosphorus 2.2. The patient's chest x-ray showed no acute findings. CT chest showed extensive acute bilateral pulmonary emboli involving most of the lobar and segmental branches, right greater than left with no saddle embolus. Findings borderline for right heart strain, correlate with echocardiogram. Peripheral ground-glass airspace opacities consistent with atypical/viral pneumonitis. Reactive mediastinal and hilar lymphadenopathy. EKG showed normal sinus rhythm, heart rate 93 with inferior infarct-age undetermined. The patient was administered 1 L IV NS, ceftriaxone 1 g IV, azithromycin 500 mg IV, and heparin IV bolus and drip for PE indication. Remdesivir started. 2/28/21: Pt on 3 L oxygen. Azithromycin, ceftriaxone, remdesivir continued. Vancomycin started. 3/1/21: 1 L oxygen via nasal cannula. Small, nonproductive cough. Pt complains of SOB. 3/2/21: 1/2 blood cultures from 2/27 positive for CoNS. Vancomycin discontinued. Pt feeling much better. Still on 1 L oxygen via nasal cannula. More alert. 3/3: 5 day remdesivir course and azithromycin, ceftriaxone course completed. Patient weaned off oxygen. Pt discharged home with oxygen as a precaution. Pt also enrolled in COVID Safe At Home telehealth program.
73 2021-03-04 blood pressure increased 3/3/21 3 hours after injection I experienced severe right foot pain I cannot bear any weight on my... Read more
3/3/21 3 hours after injection I experienced severe right foot pain I cannot bear any weight on my right foot and severely painful to touch. Some friends massaged my foot and applied some warm compress and I was able to walk with a limp. 3/4/21 at 1:30 am and 4 am, I had severe chills but no shaking. Whole day 3/4 I felt lousy with lots of belching but able to walk better after some more massages with menthol/eucalyptus rub. On 3/5 today, my blood pressure was elevated to 150-160/78-74. I have headaches and pain on my neck. My blood pressure before 3/3/21 has been ranging from 126-134/70-80. My temperature was running 97.8.
73 2021-03-04 chest discomfort, loss of consciousness, hypotension, pallor Immediately following the injection soreness and muscle pain in arm. Headache began to worsen overni... Read more
Immediately following the injection soreness and muscle pain in arm. Headache began to worsen overnight. 2pm throbbing headache, muscle pain throughout body, tightness in chest, coughing. Very lathargic and severe headache. Unable to talk due to fatigue(Asthenia). 6pm severe symptoms including, headache, body ache, fatigue, tight chest, muscle pain, nausea, chills, sweats, unable to call for help. Unable to control bowels...soiled self. Attempted to get to bathroom fell against walls and furniture. Feces everywhere in home, dehydration has been a big problem. Low blood pressure 107/40. Disoriented, lathargic and pale. Trouble keeping fluid down or in..forgetful and unable to keep a thought. Blacked out .etc.
73 2021-03-04 chest pain Chest pain, sore throat, uncomfortable breathing, neck glands extremely sore, painful teeth, pain in... Read more
Chest pain, sore throat, uncomfortable breathing, neck glands extremely sore, painful teeth, pain in right ear, extreme tiredness (3 days not enough energy to get out of bed, not wanting to eat but no upset stomach. No personal doctor so did not seek medical attention. Took tylenol and did breathing exercises. After beginning to feel better took Mucinex and Sudafed. Day 4 started getting strength back. Day 5 walking inside of home.
73 2021-03-04 haemoglobin decreased, loss of consciousness emergency room HPI 73 y.o. female who presents with dizziness and loss of consciousness. Patient rep... Read more
emergency room HPI 73 y.o. female who presents with dizziness and loss of consciousness. Patient reports that she was sitting outside in the sun this afternoon and became hot, she then went inside and came back outside to sit in the shade. She reports that she became "dizzy," lightheaded, nauseous, and that her vision began to go black. Reports that she awoke to her sister shaking her in the chair and calling EMS. Unsure of LOC time, but believes it to be short-lived. She then had one episode of vomiting. Denies vertigo, hitting head, trauma, headache, chest pain, palpitations, shortness of breath, and edema. Denies recent illness or sick contacts. Denies h/o similar episodes.
73 2021-03-04 heart rate increased fever,chills ,vomiting,nausea,.fast heartbeat. In bed for3 days
73 2021-03-04 pulse abnormal Started with mild headache, mild nausea, then pounding, bounding pulse of about 80 (my resting is us... Read more
Started with mild headache, mild nausea, then pounding, bounding pulse of about 80 (my resting is usually 60) THIS WAS THE SYMPTOM THAT MOST CONCERNED ME AS I HAVE A DILATED ASCENDING THORACIC AORTA) chills intermittent on first day required heat, blankets, 2nd day (yesterday) chills were intermittent throughout the day; a feeling of "foggy brain", fatigued muscles especially thighs, aching joints, aching muscles, unable to fix a meal or to stand for long, considered calling for help, but no fever, no breathing difficulty, just rested, slept off and on 17 hours first day, yesterday normal sleep, today feel fine, so glad this has resolved! My adult disabled son had NO symptoms for first or second shot. I had no symptoms at FIRST shot. This SECOND ONE WAS A DOOZY!
73 2021-03-05 chest discomfort On the morning of Feb 2, it felt like a switch went off in my head. I felt spacey and disconnected. ... Read more
On the morning of Feb 2, it felt like a switch went off in my head. I felt spacey and disconnected. I went for a walk and felt better but tired. I then started to feel anxious and tired the next day. The third day I not only felt anxious but agitated. This seemed very similar to being on Prednisone. That day I called my doctor and took Ativan. We waited another week to see if the aniety would go away. It did not and I am currently on Lexipro. I walk almost everyday and it really helped with the onset of anxiety after the shot. However, F Feb 14 I felt chest pressure while walking which I had never felt before. After returning home, I went to the ER. All tests were negative for a heart attack. I am hesitant to get the second dose. I am currently seeing a cardiologist to determine what may have caused the event.
73 2021-03-07 blood glucose increased, fainting Pt developed vomiting, syncope, urinary incontinence the evening of 3-2-21 at 9:00pm. She continued ... Read more
Pt developed vomiting, syncope, urinary incontinence the evening of 3-2-21 at 9:00pm. She continued to vomit through the night and had 1 syncope episode when trying to get up. on the morning of 3-3-21, pt was ambulating with assistance to the restroom and had a syncopy episode, confusion and fell and hit her head on a chair. 911 was called and pt was transported to ER, pt was found to be dehydrated and had elevated blood sugar( < 300) per daughter. ) admitted overnight for observation.
73 2021-03-08 blood pressure increased Bell's Palsy type of reaction, sagging on left side of face primarily at the chin line. some puffyn... Read more
Bell's Palsy type of reaction, sagging on left side of face primarily at the chin line. some puffyness. Tingling sensation from chin to temple. Tightness around the face. Blood pressure elevated. No adverse effects prior to this. Have read that others having this reaction have had facial injections of Botox or fillers. I have never had this. No treatment was given. I used a warm compress and exercised my muscles by trying to whistle. Facial symptoms went away in 48-72 hours. Still working on the blood pressure.
73 2021-03-08 fibrin d dimer increased, heart rate increased, chest discomfort 2/11/2021 - Sore swollen left arm with rash around injection site. 2/12/21 Awoke with swollen left s... Read more
2/11/2021 - Sore swollen left arm with rash around injection site. 2/12/21 Awoke with swollen left side of neck and sore left lymph under ear/jaw bone. 2/17/21 - Shortness of breath, chest tightness, dizzy, trouble thinking. Went to ER 3/07/2021 - To - High heart beat, blood pressure, nausea, dizzy, have trouble thinking. Blood pressure back under control but dizziness and nausea when up and thinking problems continue.
73 2021-03-08 hypertension, fainting pt received shot and after a few minutes started feeling dizzy and faint.....pt sat in lobby for abo... Read more
pt received shot and after a few minutes started feeling dizzy and faint.....pt sat in lobby for about an hour and a half and we checked blood pressure several times and it was 160/80, and it stayed high for a long time until patient took some valium she had. It then went down to 145/69.....pt was also very cold......pt ate something and drank some water. After an hour and a half pt was able to get up and walk away. Patient was offered medical attention from ambulance but refused. Pt said she would go to urgent care if needed she lives near one.
73 2021-03-08 oxygen saturation decreased, heart rate increased, chest discomfort heavy weight was pressuring their chest/experienced like a heavy thing was moving across their chest... Read more
heavy weight was pressuring their chest/experienced like a heavy thing was moving across their chest; hard time breathing as if earing several masks over their head/They felt their breathing was inhibited; oxygen level dropped to 80%; pulse was at 115; heart was really fastthrough the days, beating really fast and feeling it was moving up the throat given a choking feeling; A spontaneous report was received from a consumer who was a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a heavy weight was pressuring their chest from the inside, and also felt like a heavy pressure coming from outside their body/Chest discomfort, like a heavy thing was moving across their chest, they had a hard time breathing as if earing several masks over their head felt their breathing was inhibited/dyspnea, oxygen level dropped to 80%/oxygen saturation decreased, pulse was at 115/ heart rate increased, felt their heart was fast trough the day regularly, for 5 days, beating really fast and feeling like it was moving up their throat, giving them a choking feeling/choking sensation. The patient's medical history included high blood pressure, and thyroid disorder. Concomitant medications included enalapril hydrochlorothiazide, simvastatin for "cholesterol" and a "thyroid medication." On 29-Jan-2021, at 0931, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29-Jan-2021, 46 minutes after vaccine administration, patient reported that she started feeling like a heavy weight was pressuring her chest from the inside and also felt like a heavy pressure was coming from outside her body. At 1100, she stated that she experienced a feeling like a heavy thing was moving across her chest and she reportedly had a hard time breathing. Her oxygen level dropped to 80%, but by breathing intensely she managed to bring it to 84-87%. She reported her pulse to be 115. All of these symptoms lasted for 20 minutes. Later, she reported that her oxygen level returned to 90% and then eventually to 94%. However, she reported that for the next few days she felt like her heart rate was fast through the day, for about 5 days. She said that she felt like it was beating really fast and felt like it was moving up her throat, giving her a choking feeling. Since last Friday, 05-Feb-2021, she stated that she has had no more problems. Patient reached out to her HCP who denied her any post-vaccine related attention. Treatment activities for event included taking ibuprofen 600 mg after the vaccination. Action taken with mRNA-1273 in response to the events was unknown. The outcome of event, experienced a heavy weight was pressuring their chest from the inside, and also felt like a heavy pressure coming from outside their body, like a heavy thing was moving across their chest, they had a hard time breathing as if earing several masks over their head felt their breathing was inhibited, oxygen level dropped to 80%, pulse was at 115, was considered recovered/resolved.; Reporter's Comments: This case concerns a 73-year-old female who experienced serious unexpected events of Chest discomfort, dyspnea, oxygen saturation decreased along with a nonserious unexpected events of heart rate increased and choking sensation. Event onset 46 minutes after the first dose of mRNA-1273. Treatment with ibuprofen. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
73 2021-03-09 body temperature decreased following evening back pain lower left side for 2 days. Moved to stomach on left side and back. At ... Read more
following evening back pain lower left side for 2 days. Moved to stomach on left side and back. At this time urine was orange in color and had a foul Oder for 3 days followed by stomach pain still but more intense and dysentery. Called Dr office when I had blood clots the size of quarters or better, Nurse suggested I go to emergency. I did not, this continued for 3 days and then subsided. I still am having chills and a temp of 96.7.. At this point I am concerned to get the second vaccine on the 29 th of this month.
73 2021-03-09 chest discomfort Tightness of chest and short of breath. Lasted 3 days and then got better as time went on
73 2021-03-09 fainting Pt felt dizzy and started shaking, and then fainted. awoke on the floor had been passed out for grea... Read more
Pt felt dizzy and started shaking, and then fainted. awoke on the floor had been passed out for greater than 30 minutes per patient.
73 2021-03-10 ischaemic stroke Acute ischemic lacunar stroke in left ligament resulting in mild left leg weakness
73 2021-03-10 palpitations 101 fever, rapid heartbeat, dry cough,
73 2021-03-10 fainting Client's spouse reported almost 24 hours after vaccination episode syncope around 12:00 p.m. the nex... Read more
Client's spouse reported almost 24 hours after vaccination episode syncope around 12:00 p.m. the next day (02/12/2021).
73 2021-03-11 blood pressure increased Increased blood pressure for 24 hours
73 2021-03-11 cerebrovascular accident Extreme fatigue began on 3/3/21 (3 weeks post vaccine). Left sided facial drop and left sided weakne... Read more
Extreme fatigue began on 3/3/21 (3 weeks post vaccine). Left sided facial drop and left sided weakness began on 3/6/21. 2 days later, symptoms were communicated to doctor and patient admitted to hospital, where CT scan and MRI confirmed right-sided stroke. No predisposing factors (no preceding HTN, non- smoker, normal carotid arteries, no congenital heart defects, not on OCP, no history of blood clots or abnormal clotting factors.)
73 2021-03-11 heart rate increased Face swelling, throat closing, rash, headache, rapid heartbeat, weak, dizziness. Having an anaphyla... Read more
Face swelling, throat closing, rash, headache, rapid heartbeat, weak, dizziness. Having an anaphylactic reaction
73 2021-03-11 fainting On March 2, areas of red rash with welts started to appear on inner knees. By evening an continuing ... Read more
On March 2, areas of red rash with welts started to appear on inner knees. By evening an continuing into the night of March 3, these red rash areas with large welts spread all over body. A steroid ointment and antihistamine were used to calm. After approximately 5 days the rash was gone. This rash appeared to look like the internet article pictures from BFF and Self, only the pictures were of the arm of injection.
73 2021-03-12 fast heart rate Within forty minutes of receiving the vaccine, the back of my tongue felt "fat", no other way to des... Read more
Within forty minutes of receiving the vaccine, the back of my tongue felt "fat", no other way to describe it. Within an hour, my arms and legs were tingling and felt numb, much like when a leg or arm falls asleep, with intermittent chills running down the limb then gone. I had five episodes of tachycardia on 3-12-21, only two brief episodes today, 3-13-21. 48 hours later and I still experience a brief surge of the numb and tingling feeling, but it's so much better. The vaccination site itched profusely but that has eased. I began taking Benadryl and Advil approximately four hours after receiving the vaccine and it did help.
73 2021-03-13 oxygen saturation decreased High fever from 103-104 for 8 hours, chills, low oxygen level of 88%, erratic breathing. on the 2nd... Read more
High fever from 103-104 for 8 hours, chills, low oxygen level of 88%, erratic breathing. on the 2nd day fever dropped to 100 and oxygen level went up to 98%. On the 3rd night fever broke and woke up with extreme sweating. Next day fever was 99. During all the days above I was extremely dizzy. I started increasing my water and electrolyte in take and started feeling normal on the 7th day.
73 2021-03-14 chest discomfort First injection - had Covid rash 2 weeks later in left arm Second injection - 45 min after injection... Read more
First injection - had Covid rash 2 weeks later in left arm Second injection - 45 min after injection, constant clearing of throat and chest issue, took 25 mg benadryl, helped. Next morning woke up with fever 100.8, nauseaus, headache, very tired and hot and cold. next day, still fever and chills, tired and sweaty, headache. Fever dropped in the afternoon of second day (3rd day after shot). Hopefully better by next day or I will call my doctor. taking Tylenol regularly.
73 2021-03-14 heart rate irregular, cardiac arrhythmia Irregular Heartbeat PVCs Three hours in length
73 2021-03-14 palpitations Patient woke up in the middle of the night 4-5 days post vaccination (first dose) around 12-12:30am.... Read more
Patient woke up in the middle of the night 4-5 days post vaccination (first dose) around 12-12:30am. Chief complaint: mucus in eyes, sinus pain, sores in mouth, pruritis on trunk/breast/underarm, heart palpitations. Patient took Tylenol at 1 am and was completely resolved by 2:30am same night. Patient unable to attribute symptoms to any other cause.
73 2021-03-16 chest discomfort chest heaviness, body aches. lymph swelling
73 2021-03-16 loss of consciousness passed out VOMITING DIDN'T TAKE TYLENOL couldn't open mouth PRESSURE TOP OF HEAD
73 2021-03-17 platelet count decreased Patient was found to have abnormally low platelet count of 12 two weeks after receiving COVID vacci... Read more
Patient was found to have abnormally low platelet count of 12 two weeks after receiving COVID vaccine. In last few days leading up to ED visit and hospitalization, started to have bruising which prompted blood count draw. Patient has cancer and undergoing XRT, but is currently not on any chemotherapy or bone marrow suppression treatment. Patient was treated with prednisone 40 mg daily and platelets increased to 17 then decreased to 14. The patient subsequently received IVIG and nplate treatment and was discharged with follow-up set up with Hematology outpatient.
73 2021-03-18 blood pressure increased Pt reported mild sob, lightheadedness, flushed, elevated BP
73 2021-03-18 blood pressure increased Client was vaccinated with 2nd dose Moderna on 3/10. Client showed no signs of adverse reaction at t... Read more
Client was vaccinated with 2nd dose Moderna on 3/10. Client showed no signs of adverse reaction at time of vaccination or during post-vax monitoring. On 3/14, client started to notice swelling of face. Client went to receive care and was told that it indicated an allergic response. There was "no throat involvement" according to the client. Client's blood pressure was also elevated during the event (see below). This reporter is unaware of any medications administered in the care of the physician. Client recovered and is feeling better now with no residual symptoms. Client came to the site today to report these occurrences to us.
73 2021-03-18 hypertension rapid breathing high blood pressure almost fainted super flushed face
73 2021-03-18 loss of consciousness confused; extremely weak; cold and clammy; barely could move arm; banged head on cabinet; overwhelmi... Read more
confused; extremely weak; cold and clammy; barely could move arm; banged head on cabinet; overwhelming nausea; lost consciousness; arm hurt a little bit/throbbing pain; Felt fatigued; A spontaneous report was received from a consumer, who was also a 73-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm hurt a little bit/throbbing pain, felt fatigued, confused, overwhelming nausea, lost consciousness, banged her head on the cabinet, extremely weak, cold and clammy and barely could move arm . The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Feb 2021, the patient received the first of the two planned doses of mRNA-1273 (batch# 007M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On the night of 13 Feb 20212, the patient experienced arm hurt a little bit and she felt fatigued. In the early morning of 14 Feb 2021, the patient went to the bathroom. On her way to the bathroom, she felt confused and had overwhelming nausea. She lost consciousness and banged her head on the cabinet. Within second, she regained consciousness but felt extremely weak. She could not recall how she got back to her bed. The patient said she was cold and clammy at that time and she never got back to sleep. During the day on 14 Feb 2021, the patient felt a throbbing pain on the arm where she got the injection. She was not sure whether that was due to the injection or due to her fall when she lost consciousness. She could barely move the arm. Then she took a nap in the afternoon and was able to recover from her lack of sleep that night. Treatment for the events included paracetamol. Action taken with mRNA-1273 in response to the events was unknown (although her doctor advised her not to get the second dose given the reaction she had). The outcome of the events was resolved on 15 Feb 2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Additional information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
73 2021-03-19 palpitations Patient states 6 hours after receiving second dose of Moderna COVID19 vaccine she got very lighthead... Read more
Patient states 6 hours after receiving second dose of Moderna COVID19 vaccine she got very lightheaded and dizzy. She started getting heart palpitations and called 911. She went to the ER and they gave her a SL tablet. She then was very tired and slept. She felt better the next morning and has been feeling better since.
73 2021-03-19 palpitations Patient states 6 hours after receiving second dose of Moderna COVID19 vaccine she got very lighthead... Read more
Patient states 6 hours after receiving second dose of Moderna COVID19 vaccine she got very lightheaded and dizzy. She had heart palpitations and called 911. She had trouble standing, had nystagmus, couldn't catch her breath, and felt nauseous and wanted to throw up. Her palms felt numb and cramped up and her legs moved without control. She went to the ER and they gave her a SL tablet. She then was very tired and slept overnight. She felt better the next day but her stomach was still upset and nauseous. She felt better 3/15/21. Her first shot of the Moderna vaccine she tolerated, LOT # 042L20A received 2/8/21.
73 2021-03-20 palpitations, blood pressure increased Brain felt fuzzy. Weak. Hands shaking. Heart pounding. blood pressure went up to 181 over 106 had to... Read more
Brain felt fuzzy. Weak. Hands shaking. Heart pounding. blood pressure went up to 181 over 106 had to quickly lay on the floor until paramedics arrived. I was taken to hospital. Took 2 hours to feel well enough to go home. I slept most of 2 days. Tiredness comes and goes.
73 2021-03-21 very slow heart rate, lightheadedness Near syncopal event with Bradycardia
73 2021-03-21 heart rate increased, arrhythmia On Sunday 2/14, pt notes that she experienced chills and "just felt out of sorts." On 3/15 at 1:30p... Read more
On Sunday 2/14, pt notes that she experienced chills and "just felt out of sorts." On 3/15 at 1:30pm, she was scheduled for a wellness exam with her primary care provider. She notes that when staff took her vital, they were concerned because she seemed short of breath. Pt notes that she is overweight and does have dypsnea on exertion at times, but staff were concerned because she had been at rest for some time and they considered the shortness of breath unusual. Pt reports that her blood pressure was normal and her O2 sats were running 97-98% on room air. However, her pulse was 150. An EKG was done and the physician voiced concern over how long her pulse had been elevated. She was transferred to the ED, where per her report another EKG showed that she was in atrial flutter. Pt reports that she was treated with IV Cardizem and given and IV bolus of magnesium. At approximately 4:30pm, a CT with contrast was completed to rule out blood clot or PE. A third EKG done in the ED revealed that she had returned to normal sinus rhythm. She was discharged home at 6:30pm. Pt reports that she was seen for follow up on 3/20. At that time, her physician ordered repeat labs - CMP, potassium, magnesium, and thyroid - all of which were normal per her report. He changed her medication from baby aspirin 81 mg to Zarelto 20 mg, noting that she is at high risk for stroke. Cardiology has been alerted and she has an ECHO scheduled . Since her discharge from the ED, pt has been monitoring her pulse daily and it have ranged from 66-72 bpm/
73 2021-03-21 heart rate increased Woke up at 3:30 am after getting the shot. Was shaking uncontrollably, freezing, deathly sick at my... Read more
Woke up at 3:30 am after getting the shot. Was shaking uncontrollably, freezing, deathly sick at my stomach. Fever. For next 24 hours I was deathly sick at my stomach. Dry heaves. Fever and chills. Could barely raise my head. Couldn't even eat a cracker. Then my arm started hurting, got big long red knot,hurt down the inside for about a week. I was sick like this for almost 48 hours. I was exhausted, so tired. This lasted for a week. After the first week, every afternoon I would get exhausted and have to stop and rest. First shot effected my breathing, causing rapid breathing, like I was anxious. Had a headache. My heart beat fast for about 20 hours. Then all of it stopped. Several days later I got a round red hot knot that stayed about a week or two and was really sore.
73 2021-03-21 fainting pt stated that she was at work and she started getting dizzy and collapsed. She was sent home and h... Read more
pt stated that she was at work and she started getting dizzy and collapsed. She was sent home and has been weak, had chills and nauseated. On 3/21/2021 she was feeling some better Today 3/22/2021 she woke up with fatigue and nausea.
73 2021-03-22 blood glucose increased, fainting, blood pressure decreased 3/19/2021- Dizziness, Abd discomfort, diarrhea, blood glucose greater than 1000 3/20/2021- syncope a... Read more
3/19/2021- Dizziness, Abd discomfort, diarrhea, blood glucose greater than 1000 3/20/2021- syncope and collapse resulting in tib/fib fracture, decreased BP ( admitted to local ICU) 3/22/2021- tested COVID positive
73 2021-03-22 transient ischaemic attack, palpitations A little over 24 hours after first vaccination shot suffered a suspected TIA. Symptoms: Shortness o... Read more
A little over 24 hours after first vaccination shot suffered a suspected TIA. Symptoms: Shortness of breath, extreme weakness, racing heart, visual disturbance, inability to move. Episode lasted approximately 1 hour. Was unable to call for help or pick up phone to dial 911.
73 2021-03-23 fainting During night, some body aches and headache. Woke up on 3/24/21 and got out of bed and had extreme n... Read more
During night, some body aches and headache. Woke up on 3/24/21 and got out of bed and had extreme nausea, dizziness, weakness, 2 bouts of diarrhea, and fainted once. Also some body aches and headache still. I am now taking it super easy as I don't want to fall again.
73 2021-03-23 fast heart rate, loss of consciousness, hypertension Extremely dizzy; Don't remember nothing; Felt like she was going to died; Felt so sick; Completely u... Read more
Extremely dizzy; Don't remember nothing; Felt like she was going to died; Felt so sick; Completely unconscious/passed out; High blood pressure 215 over 156; Vomiting for 1 hour constantly/threw up; Nauseate; Headache like someone is pressure her brain; Fast heartbeat; Weak; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced the following: completely unconscious/passed out(loss of consciousness), dizziness, vomiting for 1 hour constantly/threw up (vomiting), don't remember nothing (amnesia), felt like she was going to died (feeling abnormal), high blood pressure 215 over 156 (hypertension), felt so sick (malaise), headache like someone is pressure her brain (headache), fast heartbeat (tachycardia), nauseate (nausea) and weak (asthenia). The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin, bupropion hydrochloride, cetirizine hydrochloride, anxiety medicines, clonazepam, metformin, metoprolol, and trazodone. On 01 Mar 2021, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: unknown) and 45 minutes later was extremely dizzy. At home one hour later she started to vomit for one hour constantly, became completely unconscious, didn't remember anything, and was really scared. The last thing she remembered was telling her husband: you need to call somebody because she felt like she was going to die. The patient was taken by ambulance to the hospital and while in the ambulance, the patient was administered medicines for nausea and blood pressure. The blood pressure measurement taken in the ambulance was 215 over 156. The patient didn't know her address or anything else. She was released to go home after a few hours, but still felt so sick. On Sunday night (07-Mar-2021), the patient threw up again. On an unspecified date, she had a headache like someone was putting pressure on her brain; she also had a fast heartbeat. Since the vaccine, the patient reported feeling really nauseous and remembering nothing about it. She is still weak. Treatment information included ondansetron medicine for nausea. Action taken with mRNA-1273 in response to the events was unknown. At the time of reporting, the outcome of the event, weak, was considered not recovered/not resolved. The outcome of the events, completely unconscious/ passed out, dizziness, vomiting for 1 hour constantly/threw up, don't remember nothing, felt like she was going to died, high blood pressure 215 over 156 , felt so sick, headache like someone is pressure her brain, fast heartbeat, and nauseate were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
73 2021-03-24 arrhythmia Dizziness, lightheaded, arrythmia
73 2021-03-24 atrial fibrillation, cardiac failure congestive Atrial fibrillation and CHF on March 22, 2021
73 2021-03-24 atrial fibrillation Diagnosed with Afib; Couldn't breath/Gasping for air; Eyes yellow; Asthma flairup; Couldn't sleep; S... Read more
Diagnosed with Afib; Couldn't breath/Gasping for air; Eyes yellow; Asthma flairup; Couldn't sleep; Shaking; A spontaneous report was received from a consumer concerning a 73-year old female patient, who experienced asthma flair up, couldn't sleep, couldn't breathe, gasping for air, shaking, eyes yellow, admitted to hospital, diagnosed with Afib . The patient's medical history mentions asthmatic since the age of 3 years old and Atrial fibrillation. Concomitant medications provided were steroids NOS and a zpack. On 16 Jan 2021, one month and 6 days prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (Batch number: 0281120A) for prophylaxis of COVID-19 infection. On 08 Feb 2021, patient reported having an asthmatic flair up that was bad. She took medication provided by her hcp and could not sleep, could not breathe, gasping for air, eyes yellow and shaking. She was admitted to the hospital on 11 Feb 2021 and was diagnosed with Atrial fibrillation. She missed her planned dose as she was hospitalized. The event atrial fibrillation was deemed medically significant and the patient was also hospitalized. Treatment information mentions Xanax. Lab tests were not provided. Action taken with respect to mRNA-1273 was not reported. The outcome of the events, atrial fibrillation was unknown. The outcome of the events asthma flair up, couldn't sleep, couldn't breathe, gasping for air, shaking, eyes yellow, admitted to hospital was resolved on 21 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
73 2021-03-24 cerebrovascular accident She experienced stroke,between the first and second dose; I'm not speaking well; Patient had difficu... Read more
She experienced stroke,between the first and second dose; I'm not speaking well; Patient had difficulties to understand; A spontaneous report was received from a consumer concerning, a 73 year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced stroke (cerebrovascular accident) and was not able to speak well (speech disorder) and understand (confusional state). The patient had claustrophobia. Concomitant medications were multivitamins. On an unknown date, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number: 00M20A), intramuscularly in the arm for prophylaxis of COVID-19 infection. On an unknown date in Mar 2021, after administering the vaccine, the consumer experienced stroke. She was hospitalized to perform an open-MRI as she was claustrophobic. Reporter also stated that patient was not able to speak and understand well and required an assistance while speaking over the phone at the time of this report. Patient did not receive any treatment. On 10 Mar 2021, after the events occurred, the patient received her second of two planned doses of mRNA-1273 (Batch number: 044A21A), intramuscularly in the arm for prophylaxis of COVID-19 infection. The outcome of the event stroke was unknown and the events speech disorder and confusional state were not recovered at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
73 2021-03-24 cerebrovascular accident 2 weeks after I had a stroke, my right arm went completely dead and its coming back but it's not bac... Read more
2 weeks after I had a stroke, my right arm went completely dead and its coming back but it's not back to normal yet.
73 2021-03-24 oxygen saturation decreased, troponin increased Dry heaves, difficulty breathing. No output in ileostomy or fistula, chills, fever started Sat. Cont... Read more
Dry heaves, difficulty breathing. No output in ileostomy or fistula, chills, fever started Sat. Continued through tues went to ER MVH
73 2021-03-25 cerebrovascular accident Felt a bit dizzy and tired. These continued with inability to securely grasp things with my left han... Read more
Felt a bit dizzy and tired. These continued with inability to securely grasp things with my left hand until Saturday March 20th when I was taken to the ER.
73 2021-03-25 chest discomfort nausea, headache, light-headed, pressure in chest
73 2021-03-25 pallor Patient received her 1st dose of Moderna vaccine around 0845. Patient was accompanied with her husb... Read more
Patient received her 1st dose of Moderna vaccine around 0845. Patient was accompanied with her husband. They were leaving the facility and nurse noticed patient needed assistance walking, she went to assist her to the vehicle and when she was helping her the patient almost fell. Nurse yelled for help, I assisted the patient to a chair outside the facility. Vital signs were obtained: BP 230/110 manual, Heart rate 110, 02 sat 95% on room air, Respirations 34. Neuro exam completed, grips were equal and strong. Patient was pale, diaphoretic, lethargic, and having shortness of breath. Patient became very nauseated and started dry heaving. History was obtained from the husband: HTN, COPD, Asthma, high cholesterol, anxiety, Chronic Back and Knee pain (currently seeing a pain clinic and is on Morphine 15mg q6 hours), wears 02 at bedtime. Patient was assisted to an exam room via wheelchair. Dr. was notified at 0924 of patient?s condition. She informed me to call the emergency medical team to come assess her and transport to nearest hospital. At 0925, 911 was notified. Vital signs obtained: 0926: BP 193/83, HR 114, Resp 38, 02 Sat 95% on room air. 0930: Patient still having some shortness of breath, dry heaving, and nausea. 02 was placed at 2L BNC to assist with the shortness of breath. 0931: BP 157/76, HR 102, 02 Sat 98% on 2L, Resp 32 0935: 1st responder arrived 0935: BP 171/96, HR 99, 02 Sat 99% on 2L, Resp 30 0940: Ambulance arrived to assess patient 0945: EMS suggested to go to nearest hospital ER to be assessed by a doctor. Patient and husband refused to be transported. Patient?s husband stated, ?She has episodes like this all the time.? He stated, ?I will take her to the ER if I feel that she needs to go.? 0955: Ambulance crew left health department 0958: Patient signed AMA form, patient left AMA with husband as driver.
73 2021-03-25 palpitations covid arm; headache; hypothyroidism became hyperthyroidism; heart palpitations; vertigo; extreme muc... Read more
covid arm; headache; hypothyroidism became hyperthyroidism; heart palpitations; vertigo; extreme mucus; unable to sleep; A spontaneous report was received from a consumer (patient) which concerns a 73-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vertigo, headache, extreme mucus, heart palpitations, unable to sleep, turned hypothyroidism to hyperthyroidism and covid arm. The patient's medical history was not provided. Concomitant medications included amlodipine, diphenhydramine hydrochloride, diazepam, thyroid and vitamins (ascorbic acid; ergocalciferol; nicotinamide; retinol; riboflavin; thiamine hydrochloride). On 10-Feb-2021, the patient received first dose of mRNA-1273 (Lot number: 010M20A) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 10-Feb-2021, the night of shot the patient experienced vertigo, headache and extreme mucus that lasted 3 days. The same day as the shot she also experienced heart palpitations, unable to sleep, turned hypothyroidism to hyperthyroidism and these symptoms lasted 8 days. On 22-Feb-2021 she experienced covid arm that got better but was still present. Treatment medications included tylenol. Seriousness criteria for the event of hypothyroidism became hyperthyroidism was medically significant. Action taken with mRNA-1273 was unknown. The outcome of the event of covid arm was recovering and for all other events was recovered. No further information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
73 2021-03-25 fainting Dehydrated; Itchy; Long 4-inch rash, it was itchy; Fainted; sick, like she had a high fever; A spont... Read more
Dehydrated; Itchy; Long 4-inch rash, it was itchy; Fainted; sick, like she had a high fever; A spontaneous report was received from a consumer , who was a 73-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainting (syncope), sick like had a high fever (illness), long 4-inch rash (rash), itchy (pruritis), and dehydrated (dehydration). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 29 Jan 2021, the patient received her first of the two planned vaccine doses of mRNA-1273 (Batch number: 012M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 26 Feb 202, the patient received her second of the two planned vaccine doses of mRNA-1273 (Batch number: 014M20A), intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 27 Feb 2021 the patient was sick, like she had a high fever.. Reportedly, her temperature was not taken. She was unable to eat or drink and she fainted. It was reported that she was not aware that she fainted until the next day when her husband told her. The following Monday, she was informed by the doctor that she was dehydrated. On 28 Feb 2021, the patient developed a long 4-inch rash, that was itchy, but resolved in a week. It was reported that this reoccurs every now and then and feels itchy. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events, fainting, sick like had a high fever, long 4-inch rash, itchy, and dehydrated, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
73 2021-03-27 hypotension Eye focus issue heart rate over 120 BP low severe diarrehia head ache shaky
73 2021-03-27 loss of consciousness, fainting Moderna COVID-19 Vaccine EUA - after receiving the second dose of the moderna covid-19 vaccine, pt d... Read more
Moderna COVID-19 Vaccine EUA - after receiving the second dose of the moderna covid-19 vaccine, pt developed a red and warm to the touch face while being observed in the waiting area. Also, while being observed and these symptoms were noticed, pt fainted in the waiting area. She regained consciousness seconds later and we continued to monitor her for an additional 30 minutes. No other adverse events were noted, she declined additional assistance.
73 2021-03-27 palpitations Fever spikes, pounding heart, fatigue, mild headache, 36 hours
73 2021-03-28 hypertension, heart attack, cardiac arrest pts arm was bothering her after taking the covid vax. On 3/10/2021 pt went to Hospital to have a Ec... Read more
pts arm was bothering her after taking the covid vax. On 3/10/2021 pt went to Hospital to have a Echocardiogram procedure. Pt was sent home. The next day pt was vomiting and heaving. Her blood pressure was high and she was having symptoms of a heart attack. 911 was called. First Responder was first to arrive so pt was put on gurney and put on a flight to Hospital. Pt was loaded for the heart flight but perished in flight to the hospital due to cardiac arrest.
73 2021-03-28 palpitations PT INSTRUCTED TO WAIT 30 MINUTES DUE TO SHE STATED AFTER THE FIRST DOSE, SHE HAD HEART RACING AFTER ... Read more
PT INSTRUCTED TO WAIT 30 MINUTES DUE TO SHE STATED AFTER THE FIRST DOSE, SHE HAD HEART RACING AFTER SHE GOT HOME, BUT QUIT AND HAD NO OTHER PROBLEMS. CHECKED ON PT AFTER 20 MIN(11:05AM), SHE WAS C/O ITCHY THROAT, THROAT TIGHTNESS WITH SWALLOWING, TONGUE NUMB, LIPS NUMB. PT WAS AWAKE, A&OX4, NO DISTRESS, RESPIRATIONS RATE NORMAL AND REGULAR, PULSE RATE NORMAL AND REGULAR. AT 11:05AM BEGAN MONITORING V/S, EVERY 5-15 MIN, SYMPTOMS PERSISTED, STAFF CALLED 911 AT 11:30AM, 11:32AM DOSE OF EPINEPHRINE INJECTABLE PEN 0.3MG GIVEN IM RVL, 11:40AM EMS ARRIVED. PT WALKED TO AMBULANCE AND TAKEN TO LOCAL HOSPITAL
73 2021-03-28 fast heart rate, chest discomfort, heart rate increased She received the Moderna COVID-19 vaccine and was seen in our office on 3/1/2021. It was administere... Read more
She received the Moderna COVID-19 vaccine and was seen in our office on 3/1/2021. It was administered in her right arm. She said later that day she had itching on her arm, tachycardia, short of breath with wheezing, felt like she could pass out, muscles felt like jelly. She had to use her husband's supplemental oxygen. Later that night she felt pressure behind her left eye as if it was ready to explode. She felt dizzy When she would try to walk, she would feel so weak that she felt like she could pass out. She then developed a feeling of pressure like an elephant sitting on her neck and her chest. It was hard for her to take a deep breath. Her pulse would sometimes go up to 114. She had headaches. She has felt like she cannot focus or concentrate. She has been using Benadryl 25mg every 4-6 hours since the reaction started. When she goes about 12 hours without the Benadryl she starts to feel short of breath and the chest heaviness again. She was given Depo-Medrol 80mg injection in the office that day. She will continue taking the Benadryl until she is no longer having a reaction.
73 2021-03-30 loss of consciousness On Friday morning began suffering horribly with retching vomiting, brief periods of unconsciousness,... Read more
On Friday morning began suffering horribly with retching vomiting, brief periods of unconsciousness, and complete incontinence. Awoke Saturday morning with numbness on whole left side of body. Called Dr. and he advised go to ER immediately. Went to Hospital ER and they diagnosed a very small Lacunar stroke had occurred (ran MRI of brain). Prescribed 81mg Aspirin regimen and directed to follow-up with a Neurologist (a doctor's name and facility was provided. Made appointment and will see Dr. on 4/15/21.
73 2021-03-30 heart attack Mild Heart attack, hospitalization, delirium, hallucinations.
73 2021-03-30 fast heart rate, loss of consciousness had a rough night as she was tossing and turning; On and OFF headaches; completely unconscious; swea... Read more
had a rough night as she was tossing and turning; On and OFF headaches; completely unconscious; sweaty; collapsed on the floor; heart beats really fast when she wakes up from sleep; ended up with a concussion; arm started aching; A spontaneous report was received from a consumer, concerning herself a 73-years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced her arm started aching/ pain in extremity, she had a rough night as she was tossing and turning/ sleep disorder, she was all sweaty/hyperhidrosis, collapsed on the floor/fall, completely unconscious/loss of consciousness, headaches, ended up with a concussion/concussion and her heart beats really fast when she wakes up from sleep/tachycardia. The patient's medical history included hight blood pressure and AFib. Concomitant medications reported included diltiazem hydrochloride, apixaban, levothyroxine, montelukast, dicyclomine, alprazolam, nortriptyline. On an unknown date, the patient received their first of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection. On 24 Feb 2021, on same day prior to onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 0016MOA (?)) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 24 Feb 2021, after taking mRNA-1273, patient experienced arm started Aching, Tossing and Turning at night. Next morning on 25 Feb 2021, she went to the bathroom, she was all sweaty, collapsed on the Floor, completely unconscious, ended up with a concussion. After a week CT scan done which said everything was alright. Currently she has On and off headaches and her heart beats was fast when she wakes up from sleep. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events Aching, Tossing and Turning at night, sweaty, collapsed on the Floor, completely unconscious, ended up with a concussion, headache was not reported.; Reporter's Comments: This case concerns a 73 Y/O F with serious unexpected loss of consciousness and nonserious unexpected fall, concussion, tachycardia, pain in extremity, sleep disorder, hyperhidrosis, and expected headache. Event onset on Day 2 after the first dose of mRNA-1273. Event outcome sunknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
73 2021-03-31 anaemia Developed new onset joint pain and stiffness in bilateral hips, knees, shoulders after second vaccin... Read more
Developed new onset joint pain and stiffness in bilateral hips, knees, shoulders after second vaccination. Referred to rheumatology and currently being evaluated for possible polymyalgia rheumatica.
73 2021-04-01 blood pressure increased, heart rate increased Anaphylactic reaction/Shortness of breath/ Trouble swallowing; Weakness; Sore throat; Night sweats; ... Read more
Anaphylactic reaction/Shortness of breath/ Trouble swallowing; Weakness; Sore throat; Night sweats; Elevated blood pressure; Heart rate in 120s; feel lethargic; A spontaneous report was received from a consumer concerning for a 73 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events anaphylactic reaction, shortness of breath/ dyspnoea, trouble swallowing/ dysphagia, feel lethargic/lethargy, weakness/asthenia, night sweats and sore throat/ oropharyngeal pain, elevated blood pressure and heart rate in 120s. The patient's medical history was not provided. The concomitant medications on use were also not provided. On 11 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (lot number: 024M20A) through intramuscular route of administration for prophylaxis of COVID-19 infection. On 12 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA (lot number: 032M20A) through intramuscular route of administration for prophylaxis of COVID-19 infection. On 12 Mar 2021, within 10 minutes of second dose, patient experienced anaphylactic reaction. She experienced flushing and shortness of breath and was given oxygen, benadryl 50 mg and depomedrol intramuscularly by an EMT on site. Patient was taken to the ER for evaluation and discharged on medrol dose pak, tagamet BID and benadryl. As of today 12 days later, patient still has he following side effects: flushing beet red, trouble swallowing feels like throat is closing in, night sweats, feels lethargic, weakness, elevated blood pressure and heart rate in 120s and a sore throat. She has consulted with three HCPs since discharge and all have said to continue on her medications. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The events anaphylactic reaction, shortness of breath, trouble swallowing, feel lethargic, weakness, night sweats and sore throat blood pressure and heart rate in 120s were not recovered at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
73 2021-04-02 deep vein blood clot DVT
73 2021-04-02 blood clot Felt crummy on day one and two better on day three and on day four developed four blood clots on Cou... Read more
Felt crummy on day one and two better on day three and on day four developed four blood clots on Coumadin with an INR of 4.5 and died the next day on 3/31/2021.
73 2021-04-04 nosebleed Nose bleeds, daily. 2-3 minutes, apply pressure to stop. Pain at injection site, lasted 3 days.
73 2021-04-04 heart rate increased, fainting Went black, did not loose consciousnes, but hit the head on the tiles; Hit head on the tiles; Woke u... Read more
Went black, did not loose consciousnes, but hit the head on the tiles; Hit head on the tiles; Woke up and could not even walk; Heart was in a fast heartbeat; Weakness; Slept whole day; Dizziness; Tired; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Went black, did not loose consciousnes, but hit the head on the tiles) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Immune disorder (NOS) and Knee surgery NOS in 2019. Concurrent medical conditions included Macular degeneration. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN D3, MAGNESIUM and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced FEELING COLD (Freezing) and FATIGUE (Tired). On 22-Mar-2021, the patient experienced SYNCOPE (Went black, did not loose consciousnes, but hit the head on the tiles) (seriousness criterion medically significant), HEAD INJURY (Hit head on the tiles), GAIT INABILITY (Woke up and could not even walk), HEART RATE INCREASED (Heart was in a fast heartbeat), ASTHENIA (Weakness), SOMNOLENCE (Slept whole day) and DIZZINESS (Dizziness). At the time of the report, SYNCOPE (Went black, did not loose consciousnes, but hit the head on the tiles), HEAD INJURY (Hit head on the tiles), GAIT INABILITY (Woke up and could not even walk), HEART RATE INCREASED (Heart was in a fast heartbeat), FEELING COLD (Freezing), ASTHENIA (Weakness), SOMNOLENCE (Slept whole day), DIZZINESS (Dizziness) and FATIGUE (Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to US-MODERNATX, INC.-MOD-2021-056437 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-056437:Crosslinked case
73 2021-04-04 hypertension, troponin increased, chest pain Hypoxic respiratory failure requiring oxygen, Pneumonia, Atypical chest pain with troponin elevation... Read more
Hypoxic respiratory failure requiring oxygen, Pneumonia, Atypical chest pain with troponin elevation, uncontrolled hypertension.
73 2021-04-04 loss of consciousness EXTREME NAUSEA & VOMITING LEADING TO DEHYDRATION AND BLACK OUT. INJURIES FROM BLACK OUT CAUSED HOSP... Read more
EXTREME NAUSEA & VOMITING LEADING TO DEHYDRATION AND BLACK OUT. INJURIES FROM BLACK OUT CAUSED HOSPITAL STAY OF 2 DAYS
73 2021-04-04 palpitations Patient states that she got a rash the size of a softball on her right arm below the injection site ... Read more
Patient states that she got a rash the size of a softball on her right arm below the injection site that lasted 3 weeks. She had heart palpitations and that would come and go for about 2 weeks. She had a headache that lasted about a week and a half. She has a itchy rash on her right knee that resembles psoriasis, which she has never had. About 3 days after the vax she started having a menstrual cycle that last 20 days. She went through menopause about 15 years ago. Pt went to her OB/GYN. They did a transvaginal sonogram and a endometrial biopsy to rule out cancer. Patient is waiting for test results. Pt is waiting on a CB from her PCP.
73 2021-04-06 ischemic chest pain Will not be getting the second dose; She felt like someone stab her in the heart; Dizzy, Light Heade... Read more
Will not be getting the second dose; She felt like someone stab her in the heart; Dizzy, Light Headed; Could not see, looks fuzzy; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (She felt like someone stab her in the heart) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart disorder and Heart rate increased (She has a history of rapid heart beat.). Previously administered products included for Flu vaccination: flu (She had an allergic reaction to the flu vaccine in October 2020.) in October 2020. Past adverse reactions to the above products included Allergic reaction with flu. Concurrent medical conditions included Multiple allergies (stated "she is allergic to everything"). On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced ANGINA PECTORIS (She felt like someone stab her in the heart) (seriousness criterion medically significant), DIZZINESS (Dizzy, Light Headed) and VISUAL IMPAIRMENT (Could not see, looks fuzzy). On an unknown date, the patient experienced TREATMENT NONCOMPLIANCE (Will not be getting the second dose). At the time of the report, ANGINA PECTORIS (She felt like someone stab her in the heart), DIZZINESS (Dizzy, Light Headed), VISUAL IMPAIRMENT (Could not see, looks fuzzy) and TREATMENT NONCOMPLIANCE (Will not be getting the second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This report refers to a case of Therapy cessation for mRNA-1273 (Batch no. 013M20A) by the patient's healthcare provider. Based on the current available information and temporal association between the use of the product and the start date of the remaining events, a causal relationship cannot be excluded.
73 2021-04-06 cerebrovascular accident Speech difficulty, Mental fogginess on 4/2. Presented to hospital on 4/4. Diagnosed with Left ACA st... Read more
Speech difficulty, Mental fogginess on 4/2. Presented to hospital on 4/4. Diagnosed with Left ACA stroke on MRI on 4/6.
73 2021-04-06 chest pain Extreme fatigue, headache, severe neck pain and stiffness, nausea, joint pain, muscle pain, chest pa... Read more
Extreme fatigue, headache, severe neck pain and stiffness, nausea, joint pain, muscle pain, chest pain, abdominal pain
73 2021-04-07 cardiac arrest Death from cardiac arrest
73 2021-04-07 chest discomfort Bad headache, chills, fever, body aches, fatigue within 2-5 hours Then, tightening of chest, neck gl... Read more
Bad headache, chills, fever, body aches, fatigue within 2-5 hours Then, tightening of chest, neck glands swelling and shallow breathing (great difficulty in breathing). Breathing problem, lasted a short time. This is 3rd day and only symptoms left are body aches and fatigue. Getting better each day.
73 2021-04-07 chest pain April 5/6 evening +Fever of 100.4, red cheeks, weakness, fatigue, muscle and joint pain, feel of pre... Read more
April 5/6 evening +Fever of 100.4, red cheeks, weakness, fatigue, muscle and joint pain, feel of pressure at upper chest bone area, (not like pneumonia or racing heart), discomfort in arm area. April 7th a pink area on arm appeared. April 8. feeling better. Still discomfort in arm and tired.
73 2021-04-07 hypertension Strange feeling in mouth and throat and then felt strange and horrible all over. Pharmacist took blo... Read more
Strange feeling in mouth and throat and then felt strange and horrible all over. Pharmacist took blood pressure and it was 206/1?0. Due to extremely high blood pressure, pharmacist did not want to give me epipen and called 911. EMTs didn't want to give epipen either since bp still over 200. They said they saw beginning of hives on my face and abdomen. My throat felt weird but they did not see any swelling. They gave me a shot of Benadryl and I started to feel better after about 15 minutes. They said I should go to hospital. By the time I got to hospital I was feeling bad again. Blood pressure still high around 185, ECG ok, and oxygen ok. They gave me more Benadryl, steroids, and Pepcid via IV and Zyrtec by mouth. After a few hours I was feeling better and they discharged me with prescription for prednisone and told me to continue Benadryl as needed and Zyrtec for several days. The ER documented my mouth and throat symptoms as tingling, but it was much worse than that. Can't really describe how awful I felt.
73 2021-04-08 blood pressure increased Moderna Shot on February 23, 2021. Tired, sluggish and headache along with some ringing in the head.... Read more
Moderna Shot on February 23, 2021. Tired, sluggish and headache along with some ringing in the head. March 22, 2021 I had second Moderna shot. My arm was very swollen, fatigue and bad headache with loud ringing in the head. My blood pressure accelerated to nearly 200/88 and had to be admitted to the ER three days after shot. I was in the hospital for two days and had a series of CAT scans and ultrasounds. Loud ringing in my head has not stopped. Never had a history of high blood pressure, but now they put me on high blood pressure medication along with the baby aspirin. I was a relatively healthy woman until I had these vaccinations.
73 2021-04-08 blood clot, pulmonary embolism Pulmonary Embolism with Acute Core Pulmonale -no sign of DVT. Multiple blood clots in major arteries... Read more
Pulmonary Embolism with Acute Core Pulmonale -no sign of DVT. Multiple blood clots in major arteries of both lungs. Event began with tiredness over about. 2 week period and ended in acute event with trouble breathing. Taken to hospital via ambulance. Tests also showed right heart damage due to stress from clots.
73 2021-04-09 brain sinus blood clot On April 4, 2021, my mother, was diagnosed with a cerebral venous sinus thrombosis (CVST). I figure... Read more
On April 4, 2021, my mother, was diagnosed with a cerebral venous sinus thrombosis (CVST). I figured I would report this, as I am seeing more and more reports about the vaccines tied to this rare brain blood clot: "Moderna?s rival mRNA shot has been linked to five CVST cases out of 4 million vaccinated." "More than a dozen countries worldwide temporarily stopped administering the Oxford-AstraZeneca COVID vaccine, notes the Association of American Physicians and Surgeons (AAPS), because of deaths from blood clotting disorders, with either clots or excessive bleeding. Some patients experienced the extremely rare event of clots in the veins that drain blood from the brain (venous sinus thrombosis)."
73 2021-04-09 loss of consciousness, chest discomfort, chest pain mild anaphylactic shock; nauseated; about to pass out; bolt of tightness in her chest and across fro... Read more
mild anaphylactic shock; nauseated; about to pass out; bolt of tightness in her chest and across from her shoulder; pain in her chest; shortness of breath; dizzy/lightheadness; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (mild anaphylactic shock) and LOSS OF CONSCIOUSNESS (about to pass out) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no medical history reported ). On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (about to pass out) (seriousness criterion medically significant), CHEST DISCOMFORT (bolt of tightness in her chest and across from her shoulder), CHEST PAIN (pain in her chest), DYSPNOEA (shortness of breath) and DIZZINESS (dizzy/lightheadness). On an unknown date, the patient experienced ANAPHYLACTIC SHOCK (mild anaphylactic shock) (seriousness criterion medically significant) and NAUSEA (nauseated). On 13-Feb-2021, LOSS OF CONSCIOUSNESS (about to pass out), CHEST DISCOMFORT (bolt of tightness in her chest and across from her shoulder), CHEST PAIN (pain in her chest), DYSPNOEA (shortness of breath) and DIZZINESS (dizzy/lightheadness) had resolved. At the time of the report, ANAPHYLACTIC SHOCK (mild anaphylactic shock) and NAUSEA (nauseated) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No other relevant medication was reported. No treatment information was reported. This case concerns a 73-year-old female with serious unexpected events of anaphylactic shock and loss of consciousness, and nonserious unexpected chest pain, chest discomfort, dyspnea, dizziness, and expected nausea. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 73-year-old female with serious unexpected events of anaphylactic shock and loss of consciousness, and nonserious unexpected chest pain, chest discomfort, dyspnea, dizziness, and expected nausea. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
73 2021-04-09 fainting On the day of my 2nd vaccination, I developed chills and felt slightly queasy. I woke the next morni... Read more
On the day of my 2nd vaccination, I developed chills and felt slightly queasy. I woke the next morning with the same symptoms plus a headache. After being up several minutes, I suddenly had a syncopal episode and fell against an antique trunk I use for a coffee table, hitting my face. There was no explanation for the fainting other than the Moderna shot. I have had no symptoms since then other than the injuries I sustained from the fall. I saw a dentist the same day and have an appointment with my PA on Monday, April 12. I was encouraged to report this incident by family members since it was more than mild flu- like symptoms.
73 2021-04-10 loss of consciousness, fainting Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Det... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient called to inform us she had a reaction after her second moderna dose. She said she felt dizzy about 17 hours later and lost consciousness for a few minutes at home. She said she will followup with her doctor to get checked out.
73 2021-04-11 cerebrovascular accident CVA
73 2021-04-11 haemoglobin decreased, heart rate increased, hypotension, blood glucose increased Progressive weakness & episodes of dizziness/fall, septic shock from unknown source, acute renal fai... Read more
Progressive weakness & episodes of dizziness/fall, septic shock from unknown source, acute renal failure secondary to septic shock, metabolic acidosis, mild DKA, SIADH, newly diagnosed diabetes
73 2021-04-11 hypotension, heart rate increased, blood glucose increased vomiting with fruity odor, BG 417, weakness & SOB, Torsade de pointe & received CPR, DKA, sepsis, la... Read more
vomiting with fruity odor, BG 417, weakness & SOB, Torsade de pointe & received CPR, DKA, sepsis, lactic acidosis
73 2021-04-12 cerebrovascular accident Stroke
73 2021-04-12 hypotension Vomiting started at 11:00 PM and continued until 8:00 AM when I went to hospital. I was severely deh... Read more
Vomiting started at 11:00 PM and continued until 8:00 AM when I went to hospital. I was severely dehydrated causing temporary kidney damage. Blood pressure was extremely low. All of my numbers were alarming. I was admitted to ICU where I stayed for 5 days, followed by 6 days in PCU. Diagnosis was acute allergic reaction to vaccine.
73 2021-04-13 chest pain Hi issues; freqwuent twinges, diarrhea Right sided substernal pain
73 2021-04-14 blood pressure increased, fainting The patient reports she began with a fever 12 hours after 2nd dose of the moderna vaccine. Since the... Read more
The patient reports she began with a fever 12 hours after 2nd dose of the moderna vaccine. Since then she reports has had a fever daily from 99.0-101.8 degrees farenheit. She had a syncopal episode on both 4/13/21 and 4/14/21 while exercising. 4/14/21 she had a virtual visit with her PCP who referred her to the ER. She was seen at the ER where the patient reports she had elevated BP readings and no other abnormal findings.
73 2021-04-14 fainting Patient complained of diarrhea and vomiting the evening of 03/18. She tried to treat the symptoms. ... Read more
Patient complained of diarrhea and vomiting the evening of 03/18. She tried to treat the symptoms. On 03/20/2021 patient got light headed and fainted. Husband took her to the ER. She was admitted for 2 days and treated for dehydration. They also did a cardiac evaluation and adjusted some of her meds. Upon discharge Dr recommended that she may consider not taking the 2nd covid dose.
73 2021-04-15 cerebrovascular accident, troponin increased Patient reports she started to experience feeling a sense of doom, stool incontinence, left-sided nu... Read more
Patient reports she started to experience feeling a sense of doom, stool incontinence, left-sided numbness, altered mental status in the early hours of 3/28/21. Of note, patient received her second dose of the Moderna vaccine on 3/25/2021 and felt poorly the day after with body aches and fatigue. The patient was admitted to ED with suspected stroke, but no ischemia or hemorrhage was shown on MRI. In addition, her blood pressure at the ER was 196/104 and her troponin was elevated and reached a peak of around 5. Cardiac Catheterization showed no acute disease but chronic and unsubstantial changes that did not require intervention. An EEG from 3/29 was concerning for subacute seizure like activity and She was started on IV Keppra. MRI at the same time, also revealed a right-sided cavernoma. During her hospital stay, she had ongoing confusion and disorientation with hallucinations, concerning for an encephalitis. She also received 3 days of ceftriaoxone for a potential unseen infection, but cultures were negative and PCR for viral pathogens was also normal. She was seen to have leukocytosis but the cause was not determined. Eventually, she regained her baseline mentation with no residual deficits and was discharged on Keppra to follow up with neurology.
73 2021-04-15 chest pain Patient had a short term chest pain, she said she was fine after the 2nd half day
73 2021-04-15 fainting Patient reports received vaccine 4/14/2021. During evening hours began having nausea that persisted... Read more
Patient reports received vaccine 4/14/2021. During evening hours began having nausea that persisted all evening. During the night she was awakened. Upon getting up during the night, reports she "went down to the floor." She thinks she may have fainted but is unsure. Reports she was not injured but was unable to get up from the floor. Her husband called EMS who arrived at their home to assist patient from the floor. Reports no other symptoms other than feeling weak today.
73 2021-04-17 chest pain Leg cramps, fatigue and short chest pains lasting 10 days
73 2021-04-17 loss of consciousness Lethargic, passed out twice, loss of appetite, headache, sweating, feverish but feet and hands like ... Read more
Lethargic, passed out twice, loss of appetite, headache, sweating, feverish but feet and hands like ice, unstable - loss of balance Kept taking Tylenol after called Dr. on April 16. Was told could do nothing else because was not supposed to supress symptoms.
73 2021-04-18 deep vein blood clot, pulmonary embolism PE and DVT
73 2021-04-19 atrial fibrillation At 8:00 PM I began having chills and a headache. I checked my temperature and it was 100F. By 8:30... Read more
At 8:00 PM I began having chills and a headache. I checked my temperature and it was 100F. By 8:30 I went to bed and coughed a lot. I became nauseous and had dry heaves. My left arm was sore. I was extremely thirsty. I spent the night going to the bathroom and it became harder to do because I had excruciating pain in my lower back. I could barely walk. My Afib seemed to be acting up and I had strong chest pain and was out of breadth. This kept me up all night. By morning, I tried to get up but was unable to do so. I finally fell asleep around 1:30 p.m. and woke up a t 6:00 pm. To my relief, most of the symptoms had subsided and I could get up and walk arund.
73 2021-04-19 pulmonary embolism, deep vein blood clot Extensive DVT of right lower ext and pulmonary embolism. Taken to ER and initiated therapeutic hepar... Read more
Extensive DVT of right lower ext and pulmonary embolism. Taken to ER and initiated therapeutic heparin infusion. Now on outpatient treatment with Eliquis.
73 2021-04-20 hypertension Pt received vaccine at 10:10 AM, at 10:22 AM pt then reported some itchiness and hives to bilateral ... Read more
Pt received vaccine at 10:10 AM, at 10:22 AM pt then reported some itchiness and hives to bilateral hands. The observation nurse alerted staff. Pt reported her throat also felt itchy, initially denying any feelings of SOB or difficulty breathing. Pt BP taken at 10:22 AM 168/84. 50 mg Benadryl administered IM to R. deltoid. Pt then began stating that she felt difficulty breathing. At this time 0.3 mg Epi administered to r. thigh. EMS was called and en route during this time. Blood pressure taken multiple times and remained hypertensive. EMS arrived at 10:32 AM. Pt vitals 98% oxygen on room air, PR 67 96.9 temp, 20 RR 152/82. Pt then transported by EMS to local hospital.
73 2021-04-22 heart rate increased could not urinate; no sleep; lost 9 pounds; pulse rate is high in the 90s; could not defecate; cons... Read more
could not urinate; no sleep; lost 9 pounds; pulse rate is high in the 90s; could not defecate; constant pain in the colon on the left side, pain in my intestines; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (could not urinate) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history.). On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY RETENTION (could not urinate) (seriousness criterion medically significant), INSOMNIA (no sleep), WEIGHT DECREASED (lost 9 pounds), HEART RATE INCREASED (pulse rate is high in the 90s), DYSCHEZIA (could not defecate) and ABDOMINAL PAIN (constant pain in the colon on the left side, pain in my intestines). At the time of the report, URINARY RETENTION (could not urinate), INSOMNIA (no sleep), WEIGHT DECREASED (lost 9 pounds), HEART RATE INCREASED (pulse rate is high in the 90s), DYSCHEZIA (could not defecate) and ABDOMINAL PAIN (constant pain in the colon on the left side, pain in my intestines) outcome was unknown. The patient used blood thinners as concomitant medication. Patient states she took laxatives and other over-the-medications as treatment. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: This case concerns a 73-year-old female with a serious unexpected event of urinary retention, and non-serious unexpected dyschezia, abdominal pain, weight decreased and insomnia. Event onset with unknown latency after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 73-year-old female with a serious unexpected event of urinary retention, and nonserious unexpected dyschezia, abdominal pain, weight decreased and insomnia. Event onset with unknown latency after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
73 2021-04-22 blood clot, cerebrovascular accident I had a stroke; Blood clot; Speak was bad, couldn't form words, speak was impaired; Missed her dose ... Read more
I had a stroke; Blood clot; Speak was bad, couldn't form words, speak was impaired; Missed her dose due to to the decision not to get it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (I had a stroke) and THROMBOSIS (Blood clot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history was reported.). On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (I had a stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), SPEECH DISORDER (Speak was bad, couldn't form words, speak was impaired) and INTENTIONAL DOSE OMISSION (Missed her dose due to to the decision not to get it). On 16-Feb-2021, CEREBROVASCULAR ACCIDENT (I had a stroke) had resolved. At the time of the report, THROMBOSIS (Blood clot) and SPEECH DISORDER (Speak was bad, couldn't form words, speak was impaired) outcome was unknown and INTENTIONAL DOSE OMISSION (Missed her dose due to to the decision not to get it) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. The patient was receiving treatment with clopidogrel (Plavix) 75mg since the stroke (which is a stronger blood thinner TPA drug that resolve the blood clot). Reportedly, the patient was hospitalized for 3 days. Patient also stated that she was nervous about getting her 2nd dose so she missed her dose due to the decision not to get it with regards to the fear of having another stroke. Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked; Sender's Comments:
73 2021-04-22 blood clot Fever over 100, 3 blood clots discovered in hospital where I was sent by the Hematologist after feve... Read more
Fever over 100, 3 blood clots discovered in hospital where I was sent by the Hematologist after fever started.
73 2021-04-23 haemoglobin decreased 1st Dose of Covid-19 Covid-19 Moderna/ 013M20A 02/03/2021 2nd Dose of Covid-19 Covid-19 Moderna/012... Read more
1st Dose of Covid-19 Covid-19 Moderna/ 013M20A 02/03/2021 2nd Dose of Covid-19 Covid-19 Moderna/012A21A 03/03/2021 Since having the second vaccine I have issues with running noticeably short of breath. On April 6th I was admitted because my hemoglobin had drop to 6.9. They had to give me a blood transfusion. They also ran a scope on my upper GI, and I swallowed a camera to see if there was any blood being loss in my GI tract. None was found. The next test was to get a biopsy of my bone marrow. The results showed that the erythropoietin anti-bodies were destroying my red blood cell. My hemoglobin is still at 7.3 and the shortness of breath is still having it?s toll on me. I is my believe that the Moderna Covid-19 maybe the cause of my health issues, that I am experiencing. My breathing issues stating after getting the vaccine. I really think this information should be noted in case others may have the same problem. Please know that I had no breathing issue before getting the vaccine.
73 2021-04-23 hypertension At first my mother had a headache. Then My mother was feeling weak and could not breathe. She conti... Read more
At first my mother had a headache. Then My mother was feeling weak and could not breathe. She continued to suffer so went to the doctor to get a check up but continued to suffer and finally died on 2/8/21 due to a couple of reasons which include hypertension
73 2021-04-25 hypertension Chills, Dizziness, High Blood Pressure, "Numb," Falling, Nausea, Vomitted x 1, Sore Arm, Body Aches.
73 2021-04-25 pulmonary embolism Single subsegmental pulmonary embolism without acute cor pulmonale? (present on admission) A: Unprov... Read more
Single subsegmental pulmonary embolism without acute cor pulmonale? (present on admission) A: UnprovokedSubsegmental pulmonary emboli noted on prelim report CT chest with slight straightening of interventricular septum could reflect presence of right heart strain. Likely a larger embolism which dispersed. Currently not hypotensive. DVT negative P: Check 2D echo: if showing evidence of R heart strain will consult IR for systemic thrombolysis Therapeutic anticoagulation with Lovenox subcutaneous . Will transition to DOAC in AM tomorrow. She will need to be on for life Malignancy screening to be done as an outpatient. - morphine 4mg IV q4h as needed for pain RIGHT SIDED ABDOMINAL PAIN X 2 DAYS STARTED 4/12/21, WENT TO ER ON 4/14/21, DISCHARGED ON 4/16/21 IN STABLE CONDITION STARTED ON XARELTO 15MG DAILY FOR 21 DAYS THEN 20 MG DAILY
73 2021-04-25 transient ischaemic attack, stroke On 2/1/2021 develop minstroke, with expressive aphasia I was in hospital from 2,1-2/3/2021. 2 weeks ... Read more
On 2/1/2021 develop minstroke, with expressive aphasia I was in hospital from 2,1-2/3/2021. 2 weeks after vaccine
73 2021-04-26 fast heart rate, sinus rhythm, cardiac arrhythmia 12:42 Patient received 2nd Moderna vaccination. 12:52 Patient reports tongue tingling and swelling. ... Read more
12:42 Patient received 2nd Moderna vaccination. 12:52 Patient reports tongue tingling and swelling. 100 BPM, BP 150/90, 98% RA, R 18. Normal sinus rhythm with intermittent PVCs. 12:54 patient took own additional 25 mg Benadryl, 10 mg Claritin and Xopenex inhaler. Patient denies shortness of breath, patient speaks in full sentences, no neuro deficits. Patient denies chest pain, difficulty swallowing, N/V, itching or hives. Reports dizziness. Patient tachycardic, pulses strong and equal bilaterally, lungs CTA w/o wheezing, rhonchi or stridor. Alert and oriented x3. Call to patient?s doctor, Dr. advised patient to go to ER. Patient agrees to transport to ER. 13:27 EMS left with patient to ER. Patient?s previous VAERS report completed from 1st vaccination.
73 2021-04-27 very slow heart rate Patient became bradycardic and went in and out of consciousness. EMT took patient to private area to... Read more
Patient became bradycardic and went in and out of consciousness. EMT took patient to private area to access and EMS was notified to to take to ER.
73 2021-04-27 deep vein blood clot DVT (blood clot) in leg/her leg started to hurt; Dizziness; Headache; Fever; Chills; Didn't feel wel... Read more
DVT (blood clot) in leg/her leg started to hurt; Dizziness; Headache; Fever; Chills; Didn't feel well; felt bad; had to go to bed for 3 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (DVT (blood clot) in leg/her leg started to hurt) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure abnormal. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION COMPLICATION (Didn't feel well), PYREXIA (Fever) and CHILLS (Chills). On 08-Apr-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). In April 2021, the patient experienced FEELING ABNORMAL (felt bad) and DECREASED ACTIVITY (had to go to bed for 3 days). On 18-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT (blood clot) in leg/her leg started to hurt) (seriousness criterion medically significant). On 04-Apr-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, DEEP VEIN THROMBOSIS (DVT (blood clot) in leg/her leg started to hurt), DIZZINESS (Dizziness), FEELING ABNORMAL (felt bad) and HEADACHE (Headache) outcome was unknown and VACCINATION COMPLICATION (Didn't feel well) and DECREASED ACTIVITY (had to go to bed for 3 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient did not feel well for a couple of days. The events, fever and chills lasted for a day and half. On 07 Apr 2021 or 08 Apr 2021, the patient felt bad, experienced headaches and dizziness, and she had to go to bed for 3 days. On13 Apr 2021, the patient's leg started to hurt and she ended up going to hospital. On 18 Apr 2021, the patient was diagnosed with DVT in her leg. Concomitant medications reported included drug unspecified for blood pressure. Treatment for the event included blood thinners.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.
73 2021-04-27 fibrin d dimer increased, pulmonary embolism Bilateral PE, currently hospitalized, day 5 of inpatient status
73 2021-04-27 blood clot Headache, Increasing fatigue and difficulty breathing over two weeks before 2nd dose -- exacerbated ... Read more
Headache, Increasing fatigue and difficulty breathing over two weeks before 2nd dose -- exacerbated by 2nd dose. Worsening condition led to visit to Primary Care In office tests indicated presence of blood clots and need for emergency hospital treatment. Emergency surgery to remove blood clots throughout her body and attempt to put her on ECMO were unsuccessful and patient succumbed at 12:06 AM 3/3/21.
73 2021-04-28 palpitations, hypertension No memory of injection, racing heart, HBP. No memory of EMS arriving by @ 11:30 nor transport to ER... Read more
No memory of injection, racing heart, HBP. No memory of EMS arriving by @ 11:30 nor transport to ER. No memory of treatment at ER.Unable to provide info in ER. No memory of ER stay. Hospital, admmitted4/12/21, discharged 4/14/21
73 2021-04-28 transient ischaemic attack Ten days after I received the 2nd Moderna vaccination, I had a TIA stroke (double vision, right side... Read more
Ten days after I received the 2nd Moderna vaccination, I had a TIA stroke (double vision, right side of face and right became numb, slurred speech, could not walk). I received a TPA shot within an hour an 15 minutes of the stroke. I have no long term side effects from the stroke. I will take blood thinners the rest of my life.
73 2021-05-04 blood pressure increased Bell's Palsy type of reaction, sagging on left side of face primarily at the chin line. some puffyn... Read more
Bell's Palsy type of reaction, sagging on left side of face primarily at the chin line. some puffyness. Tingling sensation from chin to temple. Tightness around the face. Blood pressure elevated. No adverse effects prior to this. Have read that others having this reaction have had facial injections of Botox or fillers. I have never had this. No treatment was given. I used a warm compress and exercised my muscles by trying to whistle. Facial symptoms went away in 48-72 hours. Still working on the blood pressure.
73 2021-05-04 cardiac arrest Cardiac arrest, seizures death
73 2021-05-04 blood clot 1. Bulging veins appeared the day following first vaccination. From inside the left nostril onto t... Read more
1. Bulging veins appeared the day following first vaccination. From inside the left nostril onto the upper lip. on right temple above end of eye brow and between hair line, legs, behind the right knee. Behind the left knew were several large clots. 1.a. Had vein work done from November 2020 to January 2021. Clots had disappeared. 1.b. Feb. 27, 2021 clot on right temple was "in" or on top of area treated. There was pain that lasted for three days. 1.c. Told primary care doctor and saw Vein Doctor. Then there was not much concern about clots. 2. Eyes: 02/26/2021 through 02/27/2021 shooting pains around and through the eyes. Started right after vaccination. 3. Two bulging painful masses Center of forehead right and left of center of nose. 4. Lega and feet swelled 5. Toes: 03/03 toes separated and cramped on feet. Each foot two toes went left stuck together and two went right. 6. Feet 03/03/21 sore spots on top of feet. Pain made it hard to walk. Pain extended toward and over ankles and wrapped around heel.. I use a walker 7. Dizzy when looking down, shortness of breath. Contacted cardiology 8. Belching and air bubbles originating in the chest area 9. Sleep: Slept almost around the clock for first 5 days. 10. Very thirsty even after drinking water 11. Urinated more than usual. some burning. Reported to doctor. 12. Vaginal etching and dryness for 2 weeks 13. Joint Dryness; All joints but very painful and extra dry rough feeling in right hip. For 3 days 14. Stubbled when waling March 11, 12, 13, and 14 2021 15. Mind and body not working to
73 2021-05-05 chest pain, hypertension Chest pain; High Blood pressure; Dizziness; Difficulty breathing; This spontaneous case was reported... Read more
Chest pain; High Blood pressure; Dizziness; Difficulty breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain), HYPERTENSION (High Blood pressure), DIZZINESS (Dizziness) and DYSPNOEA (Difficulty breathing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization), HYPERTENSION (High Blood pressure) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to CHEST PAIN, DIZZINESS, DYSPNOEA and HYPERTENSION. At the time of the report, CHEST PAIN (Chest pain), HYPERTENSION (High Blood pressure), DIZZINESS (Dizziness) and DYSPNOEA (Difficulty breathing) outcome was unknown. Not Provided No adverse event as Medical History was reported. Concomitant medication information was not provided. She was brought into Emergency Room on 01Apr2021 and was hospitalized for two days for because of the symptoms of chest pain, High Blood pressure, Dizziness and difficulty breathing. She thought she was having a heart attack. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not provided/ unknown. Company comment: Very limited information regarding this events has been provided at this time. The company physician considers the reported onset date is typo. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. The company physician considers the reported onset date is typo. Further information has been requested.
73 2021-05-07 loss of consciousness Passed out 3 times after Moderna vaccine; hair thinning; dry skin and nose; dry skin and nose; muscl... Read more
Passed out 3 times after Moderna vaccine; hair thinning; dry skin and nose; dry skin and nose; muscle spasm in back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out 3 times after Moderna vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for Breast cancer. Concurrent medical conditions included Breast cancer, Acute cystitis, Anxiety, Lipid metabolism disorder NOS, Unspecified disorder of thyroid, Dizziness, Giddiness, Hyperlipidemia, Hypokalemia, Pure hypercholesterolemia, Thyrotoxicosis, Acquired hypothyroidism, Urinary tract infection, Drug allergy (Allergy to Amoxycillin), Drug allergy (Allergy to Sulfa) and Drug allergy (Allergy to Penicillin.). Concomitant products included DOCOSANOL (ABREVA), ANASTROZOLE, ATORVASTATIN CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE +VIT.D), MECLIZINE HCL, PROCHLORPERAZINE MALEATE, ZOLEDRONIC ACID MONOHYDRATE (ZOMETA) and LEVOTHYROXINE SODIUM (SYNTHYROID) for an unknown indication. In February 2021, the patient started PALBOCICLIB (IBRANCE) (unknown route) 125 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out 3 times after Moderna vaccine) (seriousness criterion medically significant), ALOPECIA (hair thinning), DRY SKIN (dry skin and nose), NASAL DRYNESS (dry skin and nose) and MUSCLE SPASMS (muscle spasm in back). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out 3 times after Moderna vaccine), ALOPECIA (hair thinning), DRY SKIN (dry skin and nose), NASAL DRYNESS (dry skin and nose) and MUSCLE SPASMS (muscle spasm in back) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported that the co-suspect drug Ibrance (palbociclib) was taken once daily for 21 days. The patient reported that she went to ER (emergency room) for "passing out". No treatment information was provided. Very limited information regarding these events has been provided at this time. The patient's medical history and con meds are confounders.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient's medical history and con meds are confounders.
73 2021-05-11 hypertension Flu-like symptoms developed later in day following vaccination. Continued for several days. April 2 ... Read more
Flu-like symptoms developed later in day following vaccination. Continued for several days. April 2 she followed with PCP. On April 3 she was Admitted to hospital for uncontrolled hypertension and stroke treatment/prevention. CAT Scan and other tests followed. Released from hospital on April 3 with Rx for hypertension control.
73 2021-05-13 palpitations, blood pressure fluctuation, cardiac arrhythmia She got her vaccine, she got very hot and sweaty within 10 minutes. She was still filling out her f... Read more
She got her vaccine, she got very hot and sweaty within 10 minutes. She was still filling out her form for the next vaccine. She asked a paramedic some questions, and asked if anybody else had reported anybody get hot and sweaty and he directed her to go to the open door and drink some water and rest. He asked if somebody could check her out, and came back again and asked again and they hooked her up to some electrodes and called the ambulance (somewhat foggy memory). She was having a lot of palpitations which included PVC's, and possibly other heart arrhythmias at the same time. He got to the hospital and could tell that she was going to the trauma room and they were waiting on her. She had an Echocardiogram which showed that her left bundle branch was not working, her Troponin's were going up and went from very low to high and then started trending down again. She had a cardiac cath and was told that she had nothing wrong with her heart and had a heart of a child. They mentioned Takotsubo's cardiomyopathy and wanted to do another in 6-8 weeks, which she had done and it is totally back to normal. Her blood pressure was fluctuant between high and low. When she was discharged home on the 4th day she had severe diarrhea. She was put on Plavix 75 mg, they upped her Metoprolol XL 25 mg to twice a day, they also gave her Lipitor to take briefly. They took her off baby aspirin. The recent echocardiogram was back to normal. She was told she could not get the 2nd vaccine either.
73 2021-05-16 heart rate irregular Extreme fatigue, short of breath, light headed, irregular heart beats Started 3/22. ER 4/2-4/3. Ex... Read more
Extreme fatigue, short of breath, light headed, irregular heart beats Started 3/22. ER 4/2-4/3. Extensive testing. D-Dimer 2,121 no blood clot. Zio Patch places. All tests were basically in normal range. Started to feel better early May
73 2021-05-17 chest discomfort 11:41 AM. Pt c/o chest tightness. Brought patient to triage room. V/S 167/89, HR 66, Temp 97.4, RR 1... Read more
11:41 AM. Pt c/o chest tightness. Brought patient to triage room. V/S 167/89, HR 66, Temp 97.4, RR 16, O2 SAT 98%. Provided water to drink. She stated she felt better. No other associated symptoms. Pt stated she felt better. Continued to observe. Advised when to seek medical care, AACC #, and ED precautions. Instructed parameter of BP and O2 Sat to report to clinician. Pt verb understanding.
73 2021-05-18 loss of consciousness Patient's daughter called today wanting to report an adverse event that she believed was related to ... Read more
Patient's daughter called today wanting to report an adverse event that she believed was related to mother's covid vaccine. Patient received first vaccine 3/27 and on 4/4 had to go to the ER with severe dizziness. This incident was not reported to the pharmcay until today. Patient received 2nd dose on 4/28. On 4/29, the ambulance was called by patient's husband because the patient had passed out. When she got to the ER, they determined that the patient had a seizure and she was admitted to the ICU. The patient does not have any history of seizures. She is still currently in the hospital but was moved to a regular room on 5/10 or 5/11 (daughter did not know the exact date). She is still having effects such as cannot feed herself and daughter said that communication is VERY limited.
73 2021-05-23 loss of consciousness shaking, fever, passed out, muscle weakness, lost muscle control
73 2021-05-23 ventricular tachycardia Complicated young elder with AICD for recurrent Vtach who was found unresponsive around 20 hours aft... Read more
Complicated young elder with AICD for recurrent Vtach who was found unresponsive around 20 hours after vaccine; Based on the defibrillator interrogation she had sustained ventricular tachycardia that was properly identified and treated by the device but which did not respond to device discharge, degenerated into ventricular fibrillation and unfortunately could not be terminated by her ICD. Not clear related to vaccine
73 2021-05-24 low blood oxigenation The patient received both doses of her the COVID-19 vaccine well-over a month ago, however multiple ... Read more
The patient received both doses of her the COVID-19 vaccine well-over a month ago, however multiple people at her assisted living facility have tested positive for COVID-19 in the last week or 2. She tested positive for COVID-19 on May 13th. She has been requiring a small amount of oxygen at her facility over the past few days, however her hypoxia acutely worsened yesterday, May 19th. She has had significantly worsened agitation and anxiety over the past week
73 2021-05-24 pulmonary embolism Patient admitted 5/8/21 with bilateral P. E -Spontaneous, went to Hospital 9 days post vaccine #2. ... Read more
Patient admitted 5/8/21 with bilateral P. E -Spontaneous, went to Hospital 9 days post vaccine #2. I did not give the vaccine, it was done at a vaccine clinic. Unknown if related to vaccine but within 2 weeks.
73 2021-05-24 blood clot suspected blood clot; When walking experiences traumatic pain in legs; her legs went numb while at s... Read more
suspected blood clot; When walking experiences traumatic pain in legs; her legs went numb while at store; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (suspected blood clot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (When walking experiences traumatic pain in legs) and HYPOAESTHESIA (her legs went numb while at store). On an unknown date, the patient experienced THROMBOSIS (suspected blood clot) (seriousness criterion medically significant). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at a dose of unknown. On 16-Apr-2021, HYPOAESTHESIA (her legs went numb while at store) had resolved. At the time of the report, THROMBOSIS (suspected blood clot) outcome was unknown and PAIN IN EXTREMITY (When walking experiences traumatic pain in legs) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
73 2021-05-30 nosebleed patient has had a stuffy nose all month following the vaccine. this concerned her because that was ... Read more
patient has had a stuffy nose all month following the vaccine. this concerned her because that was a major symptom of her actual Covid infection previously. she has also experienced dried blood in the nose in the mornings.
73 2021-05-31 nosebleed 3/31/2021 redness, swelling right hand , extended up middle finger up to pip joint and across metaca... Read more
3/31/2021 redness, swelling right hand , extended up middle finger up to pip joint and across metacarpals. Duration 4 days. 3 nose bleedsall on 3/31. Bloodshot right eye, moderate swelling,started 7pm on 3/31, resolved by 4/4/2021
73 2021-06-01 fast heart rate Within 20 minutes of leaving the clinic I became tachycardia and diaphoretic. I began to wheeze a... Read more
Within 20 minutes of leaving the clinic I became tachycardia and diaphoretic. I began to wheeze and have difficulty breathing. I used my rescue inhaler immediately. I began to vomit and have explosive diarrhea shortly after that. Later in the day, my temperature was 102. I took Tylenol for the fever. By evening, I had severe stomach pain. I contemplated going to the emergency room but honestly felt too sick to drive. I had almost the same reaction the 3 times I attempted to take the flu vaccine. I did go to the ER the first time I took the flu vaccine. Following the COVID vaccine, I had diarrhea for approx. 3 days . I had loose stools for a week. I was unable to eat anything but crackers for 4 days and was only able to tolerate soda as a fluid.. It took my stomach 6 weeks to return to normal. I did not take the second vaccine. I was concerned it would require me to be hospitalized.
73 2021-06-01 blood clot, pulmonary embolism blood clots in her legs; blood lot traveled to lungs, had a very severe case of blood clots; severe ... Read more
blood clots in her legs; blood lot traveled to lungs, had a very severe case of blood clots; severe pain in her legs; could not walk; weak; feeling fatigued; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots in her legs), PULMONARY EMBOLISM (blood lot traveled to lungs, had a very severe case of blood clots) and PAIN IN EXTREMITY (severe pain in her legs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe pain in her legs) (seriousness criterion hospitalization), GAIT INABILITY (could not walk), ASTHENIA (weak) and FATIGUE (feeling fatigued). On 31-Mar-2021, the patient experienced THROMBOSIS (blood clots in her legs) (seriousness criteria hospitalization and medically significant) and PULMONARY EMBOLISM (blood lot traveled to lungs, had a very severe case of blood clots) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 31-Mar-2021 due to PULMONARY EMBOLISM and THROMBOSIS. At the time of the report, THROMBOSIS (blood clots in her legs), PULMONARY EMBOLISM (blood lot traveled to lungs, had a very severe case of blood clots), PAIN IN EXTREMITY (severe pain in her legs), GAIT INABILITY (could not walk), ASTHENIA (weak) and FATIGUE (feeling fatigued) outcome was unknown. No concomitant and treatment medications were reported. The patient had no side effects from the first dose of Moderna vaccine. The patient remained hospitalized at the time of report. Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Fatigue is consistent with the Known safety profile of the product.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Fatigue is consistent with the Known safety profile of the product.
73 2021-06-02 coughing up blood, cerebrovascular accident, pulmonary embolism Patient started with c/o sinus symptoms @4/25-went to Urgent care and given zpack. Traveled out of ... Read more
Patient started with c/o sinus symptoms @4/25-went to Urgent care and given zpack. Traveled out of town. called office on 5/18 stating was in airport getting ready to fly back. Stated that never improved with zpack and was now SOB and coughing up blood. She was advised to got to hospital as soon as could when arrived back. Patient presented to ED on 4/22 and was diagnosed with bilateral PEs/pneumonia. She was admitted on aBx and lovenox. On 5/24 she had left sided CVA. CTA showed right M! large vessel occlusion. Tpa was not option and she was transferred to Health care and underwent emergent thrombolectomy. Patient currently still hospitalized
73 2021-06-03 platelet count decreased, haemoglobin decreased one month post second injection she was noted to have pancytopenia: she was urgently referred to he... Read more
one month post second injection she was noted to have pancytopenia: she was urgently referred to hematology where work up over the last month has been un revealing of etiology of pancytopenia. most recent counts are wbc 2.7, hbg 9.9, hct 28.5, PLT 14. she has required IVIG and platelets. she is needing a referral to a tertiary center.
73 2021-06-07 platelet count decreased 5/26/2020: platelets 133 12/2020: possible covid infection, but no testing done, nucleocapsid antibo... Read more
5/26/2020: platelets 133 12/2020: possible covid infection, but no testing done, nucleocapsid antibody testing pending. persistent fatigue following illness. 2/14/21: 1st dose moderna 3/14/21: 2nd dose moderna 5/24/21: plts drop to 26 on difficult lab draw. no clumping noted in lab report. no active bleeding noted by patient. 5/25/21: Repeat plts: 104. 6/8/221: repeat plts: 141
73 2021-06-07 fainting I passed out; Very hot; Very dizzy; This spontaneous case was reported by a consumer (subsequently m... Read more
I passed out; Very hot; Very dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (I passed out) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ATORVASTATIN, APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced SYNCOPE (I passed out) (seriousness criterion medically significant), FEELING HOT (Very hot) and DIZZINESS (Very dizzy). The patient was treated with AMMONIA 28-Jan-2021 at an unspecified dose and frequency and OXYGEN 28-Jan-2021 at an unspecified dose and frequency. On 28-Jan-2021, SYNCOPE (I passed out), FEELING HOT (Very hot) and DIZZINESS (Very dizzy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and strong temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up report was received on 28 -MAY-2021, and included concomitant medication, AE verbatim as described at SD body narrative, onset date for AEs and outcome of event updated.; Sender's Comments: Based on the current available information and strong temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
73 2021-06-10 heart rate decreased Low heart rate staring 3/19 afternoon, numerous hospitilizations and pacemaker implanted 5/14/21
73 2021-06-11 haemoglobin decreased, hypotension, anaemia, low blood oxigenation, fast heart rate, chest pain, fibrin d dimer increased 73 y.o. female with a past medical history of non-insulin-requiring diabetes type 2 and recent admis... Read more
73 y.o. female with a past medical history of non-insulin-requiring diabetes type 2 and recent admission at Hospital (5/31-6/6/2021) who was transferred on 6/9 for chest pain with worsening EF with concerns for ischemic cardiomyopathy. Hospital course by dates 5/31?6/6/2021: Admitted for abdominal pain, nausea and vomiting thought to be secondary to ischemic colitis and severe constipation. Patient was found to be anemic during that hospitalization, but did not require blood transfusion. Patient's hospital course was complicated by aspiration pneumonia requiring PICC placement and norepinephrine. She is no longer requiring supplemental oxygen was discharged home. 6/9: Return to hospital with increasing shortness of breath, confusion and generalized malaise. Repeat TTE with anterior wall motion abnormalities and decreased EF. Patient was transferred to bed for cardiology evaluation 6/10: Cardiac catheterization with moderate three-vessel coronary disease, wall motion abnormality does not correspond to coronary disease. Cardiology thinks findings are related to stress-induced cardiomyopathy. 6/11: Patient continues have downtrending hemoglobin, started to prep for colonoscopy on 6/12. 6/12: Rapid response was called at at approximately 4:40 AM, patient ultimately expired at 7:35 AM Patient was transferred from Hospital given new wall motion abnormalities and severe hypokinesis seen on repeat TTE. Fortunately, cardiac catheterization on 6/10 without coronary artery disease that corresponded to these wall motion abnormalities. Ultimately, it was thought to be stress induced cardiomyopathy. Patient was improving, but still complained of epigastric discomfort. Given her recent diagnosis of ischemic colitis and ongoing abdominal pain, GI was consulted for EGD/colonoscopy on 6/12 Rapid response was called at at approximately 4:40 AM. They were mottled appearing, hypotensive and cool to touch. Patient was found to be severely hypoglycemic and had wide-complex tachycardia. Multiple amps of D50 were given but remained hypoglycemic. Patient was also found to be hypoxemic and did not tolerate BiPAP. Eventually patient was transition to comfort measures only. After discussion with patient's daughter, patient's last 10 minutes of life consisted of "fluid pouring out of her mouth". Work-up also was positive for elevated lactic acid and elevated D-dimer. Given the abrupt change in patient's clinical status, concern for embolic thrombosis is the most likely cause. Unclear if had pulmonary embolism or ischemia to gut. Interestingly, patient was visiting her from Indiana for her brother's funeral. After discussion with family, patient's brother had a similar unexplained death just a few weeks prior. The Family going back to the fact that she had her second Maderna vaccine 3 days prior to presenting to select hospital. Patient's brother also had a Maderna vaccine before his recent demise. Given the unknown cause of death, an autopsy was discussed with family. They were agreeable to this. Highly concern for thrombotic event, but unable to confirm at this time without autopsy. Unknown if recent vaccine was related to her death, but could explain thrombosis leading to ischemic colitis prompting her last admission. Patient was noted to have a "severe" reaction to her first vaccine.
73 2021-06-13 heart rate irregular Fever, irregular heart beat, severe headache, dizziness, strong muscle aches, gi probl... Read more
Fever, irregular heart beat, severe headache, dizziness, strong muscle aches, gi problems, extreme fatigue,
73 2021-06-13 lightheadedness Dizziness, sweating, near fainting
73 2021-06-14 blood pressure increased My blood pressure increasing over normal levels several days a week. It makes me very fatigued and "... Read more
My blood pressure increasing over normal levels several days a week. It makes me very fatigued and "wossey" in the head.
73 2021-06-14 blood pressure increased My blood pressure started to go up and registering at higher levels several times a week. It makes ... Read more
My blood pressure started to go up and registering at higher levels several times a week. It makes me very fatigued and "wossey" in the head. The doctor thought it was a temporary side effect of the vaccine. The symptom still has not gone away.
73 2021-06-17 heart rate irregular Irregular heartbeat; Hives on cheeks, ring finger and on different parts of the body; Hives like "bo... Read more
Irregular heartbeat; Hives on cheeks, ring finger and on different parts of the body; Hives like "bombs"; Regular "flu-like" symptoms; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Irregular heartbeat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001BZ18A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to chemicals NOS (Allergy to yellow hair dye 5) and Allergy to chemicals NOS (Allergy to yellow hair dye 6). On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced URTICARIA (Hives like "bombs"), INFLUENZA LIKE ILLNESS (Regular "flu-like" symptoms) and VACCINATION SITE PAIN (Pain at the injection site). On 12-Apr-2021, the patient experienced URTICARIA (Hives on cheeks, ring finger and on different parts of the body). On 22-Apr-2021, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat) (seriousness criterion hospitalization). The patient was hospitalized on 22-Apr-2021 due to HEART RATE IRREGULAR. At the time of the report, HEART RATE IRREGULAR (Irregular heartbeat), URTICARIA (Hives on cheeks, ring finger and on different parts of the body), INFLUENZA LIKE ILLNESS (Regular "flu-like" symptoms) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown and URTICARIA (Hives like "bombs") had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient took ice and other natural things as treatment for non-serious events. On 22-Apr-2021, patient got hospitalized for irregular heartbeat and went in ambulance. She said irregular heartbeat may be due to stress. As doctor suggested she didn't take 2nd shot. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up TCR form was received on 04-May-2021. Patient had new events and was hospitalized.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
73 2021-06-20 transient ischaemic attack, arrhythmia I had the red swollen arm (injection site) - it was a little bit later - about 10 days after the va... Read more
I had the red swollen arm (injection site) - it was a little bit later - about 10 days after the vaccine. It kept getting bigger. It looked like a really bad mosquito bite that got huge. It was itchy Body aches and fatigue and headaches showed up about that time, too. Those symptoms lasted to the end of March and early April. March 17 I blew out my knee - my right knee. I ended up getting x-rays before I came to him. He called and said to go see an orthopedic surgeon and that wasn't until later on. I did see the Orthopedic Surgeon on April 8th. He injected my knee with steroids that day and took x-rays at his location. He also gave me Tylenol. Before I got to see him, March 30th - I had a TIA - Stroke. I was home alone and I called my husband and doctor (but he didn't call back right away so it was about 4 hours) and he said I needed to go to ER - Hospital ER. The treatment was cholesterol medication and referrals to cardiologists or neurologist and also an Ophthalmologist. I did see orthopedic surgeon again, again and again. I went back to Primary care doctor, too. I saw cardiologist first - April 22, 2021. I was sent to Nutritionist - on Friday, May 28th - no treatment - she said I was doing well with diet and nutrition and she would see me in 6 months. Eye exam - on June 1st - going through more tests for that - something to do with the back of the eye. June 2nd - I saw the neurologist - that was for a consultation to go over all the results from the other tests. He said there was that had happened and that nothing was very conclusive and said I should just go on with my life. In the hospital when I was admitted for my TIA - stroke - they saw that I had a thyroid issue - and so I went to thyroid doctor June 2nd. - they added - Atorvastatin and Amlodipine. I had surgery for the loop monitor for my chest on June 9th. Also there is a New nodule on my thyroid - big enough to Biopsy - on my Thyroid. On June 15th - I got the Shingrix vaccine - same arm as COVID vaccine - wild reaction from that within 24 hours that did go away the 2nd day. It was a full body flare - similar to COVID vaccine reactions but it went away quicker. I started a new medication for me called Rinvoq - for the Rheumatoid Arthritis - this replaces the Xeljanz that I had been taking. My balance is off still and I'm using a cane and I wasn't doing that before - possibly for my knee being weak. I'm getting ready for a knee replacement eventually. Since 10 years ago, I'm compromised on the right side - that is my Lymphedema side - hence all my vaccines, etc are on the left side. Otherwise, I'm feeling well now at this point.
73 2021-06-21 chest discomfort I had a 6 month follow up with my cardiologist recently, I waited until I saw him. Since receiving m... Read more
I had a 6 month follow up with my cardiologist recently, I waited until I saw him. Since receiving my second vaccine I noticed more frequently a pinching, cramping, squeezing sensation to my heart. It was something I had previously but it was getting stronger in pain and sensation. To this day I continue with the pinching sensation to my heart periodically but not as much regularity when I received the vaccine.
73 2021-06-27 blood pressure increased Sat a few moments after shot started getting dizzy pharmacist took BP and it kept going up. Felt lik... Read more
Sat a few moments after shot started getting dizzy pharmacist took BP and it kept going up. Felt like she couldn't talk and felt like pressure in her head. Vision got blurry and a few days later she had throbbing in legs
73 2021-06-28 chest discomfort Shortness of breath and chest pressure over several days. Found to have Constrictive Pericarditis re... Read more
Shortness of breath and chest pressure over several days. Found to have Constrictive Pericarditis requiring pericardiocentesis.
73 2021-06-29 arrhythmia I got the second vaccination on 06/09/21 at 9:30 AM nothing wrong, the day after arm moderate pain. ... Read more
I got the second vaccination on 06/09/21 at 9:30 AM nothing wrong, the day after arm moderate pain. Then on 6/14/21, I went to PCP for a year's check-up, during the Vital chek up my pulse went up over 150, but my Blood Pressure not too bad. The Dr took EKG show arritmia. He did't prescribe medication. I came home and call my Cardiologist, went the day after, and new medication was prescribed Metoprolol er succinate 100MG and Lisinopril -HCTZ 20/25 mG taking and Lisinopirl 20 mg at night
73 2021-06-30 heart attack Patient presented to the ED and was subsequently hospitalized for STEMI within 6 weeks of receiving ... Read more
Patient presented to the ED and was subsequently hospitalized for STEMI within 6 weeks of receiving COVID vaccination.
73 2021-07-04 fainting Patient called to let us know that about 12 hours after receiving the Moderna vaccine she had stomac... Read more
Patient called to let us know that about 12 hours after receiving the Moderna vaccine she had stomach upset and felt like vomiting. As she was walking to the bathroom she became very dizzy and fainted . Her husband was home and was able to bring her to . She is okay except for body pain from the fall and a headache. She is going to go to the doctor to get checked just to be on the safe side.
73 2021-07-05 heart flutter Heart flutter; This spontaneous case was reported by a consumer and describes the occurrence of CARD... Read more
Heart flutter; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart flutter) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced CARDIAC FLUTTER (Heart flutter) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (Heart flutter) outcome was unknown. No concomitant medication information was provided by the reporter. The patient received treatment from a cardiologist, who gave her a beta blocker. Action taken with mRNA-1273 in response to the events was not Applicable. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
73 2021-07-07 chest discomfort About 15 minutes after vaccine, started to feel heaviness in chest, pounding and hot. Layed on a li... Read more
About 15 minutes after vaccine, started to feel heaviness in chest, pounding and hot. Layed on a liter. VS monitored. Stated feeling better, but wanted to continue to lay down. About 20-25 minutes after symptoms started, BP 140/73, HR 96 and no s/s of dizziness or lightheadedness. About 1 hour later, patient got up to leave and felt vertigo and had to sit back down. Symptoms then resolved.
73 2021-07-12 transient ischaemic attack, blood glucose increased I believe the Covid vaccinations caused my blood sugar to rise causing a TIA on March 15, 2021, and... Read more
I believe the Covid vaccinations caused my blood sugar to rise causing a TIA on March 15, 2021, and loss of peripheral vision in my right eye, as well as mild changes in my close-up vison. Ater experiencing confusion and disorientation, a friend drove me to my doctor's office. From there, I was sent to the emergency room. I do not remember the exact number, but the next day I returned to my doctor's office for lab work. My blood glucose was 475 and my AiC was +14.
73 2021-07-18 low blood oxigenation 4/8 - Developed headache within 4 hours of vaccine. 4/9 - Felt like she head cold with cough and con... Read more
4/8 - Developed headache within 4 hours of vaccine. 4/9 - Felt like she head cold with cough and congestion. 4/10 - coughing and breathing worsened, went to ER treated with IV benadryl, famotidine and steroid. 4/11 - mild improvement. 4/12 - Went to PCP with facial swelling, shortness of breath, and rash. Received solumedrol's IM injection. 4/13 - slight improvement. 4/14 swelling returning. 4/15 - Return to PCP with facial swelling and rash worsening, another solumedrol IM injection given and PO prednisone ordered. 4/16 - 4/21 swelling worsened until pt began taking prednisone 40mg twice daily. Between 4/21 and 6/19 pt was tapered down on oral prednisone. Patient had return of facial rash, dermatology considered possible development of rosacea and treated with IM kenalog. Patient then had rash develop within approximately 3 weeks and biopsy is pending. PT had another ER visit in May due to severe shortness of breath and pulmonary embolism was ruled out. 7/19 ER visit due to severe shortness of breath again and cough, hypoxia present.
73 2021-07-20 chest pain, nosebleed Severe pain in Left arm, left chest, left back. Had a nose bleed and Prepared to die at home. I... Read more
Severe pain in Left arm, left chest, left back. Had a nose bleed and Prepared to die at home. I felt better after the nose bleed.
73 2021-07-20 heart attack 2 mini heart attacks the night of 4/3/2021, major heart attack morning of 4/4/2021 which lead to her... Read more
2 mini heart attacks the night of 4/3/2021, major heart attack morning of 4/4/2021 which lead to her death.
74 2021-01-07 blood pressure increased Patient developed sudden onset of severe vertigo with nausea and vomiting. She became very week. B... Read more
Patient developed sudden onset of severe vertigo with nausea and vomiting. She became very week. Blood pressure was above usual level (149/88) and she had nystagmus with no other focal neurologic signs. She continues to be "dizzy" but no true vertigo now. She is weak and fatigued.
74 2021-01-12 ventricular tachycardia, blood pressure increased A few minutes after the vaccine, she had mild tongue swelling. It only lasted a few minutes, and th... Read more
A few minutes after the vaccine, she had mild tongue swelling. It only lasted a few minutes, and then she felt fine. However, her BP went up. I'm not sure how high. she then has a short run of asymptomatic V tach. Taken to hospital observed overnight. No further events or problems.
74 2021-01-14 hypertension Anaphylactic reaction, elevated blood pressure........Benedryl......taken to emergency room at Hospi... Read more
Anaphylactic reaction, elevated blood pressure........Benedryl......taken to emergency room at Hospital......ekg, blood pressure taken, and fluids.....left hospital and went home, my choice
74 2021-01-17 blood pressure decreased 20 minutes after vax, started having a headache, feeling hot, BP was 51/37, nausea, severe pain in l... Read more
20 minutes after vax, started having a headache, feeling hot, BP was 51/37, nausea, severe pain in lower back, felt paralyzed, couldn't stand up, diarrhea, collapsed on bathroom floor. Took Zofran for nausea. went to lie down in bed and after a while, BP went back to normal.
74 2021-01-17 cardiac arrest Patient presented to our Emergency Department via EMS in full code status; asystole. Patient expire... Read more
Patient presented to our Emergency Department via EMS in full code status; asystole. Patient expired. Per nursing, husband stated patient awoke this AM and reported pain in back between shoulders and in bilateral shoulders. Patient then went unresponsive and husband called EMS.
74 2021-01-18 chest discomfort 01/13/21 - Employee was awakened approx 2AM with chest discomfort that radiated into her back.
74 2021-01-18 transient ischaemic attack About 22 hours after the shot, I had a mini stroke that required going to the emergency room by ambu... Read more
About 22 hours after the shot, I had a mini stroke that required going to the emergency room by ambulance. I was transported that evening to the stroke division that same evening for further evaluation, tests and care. I have never had a mini stroke before this.The doctors said it may have been from the vaccination, or it may not have been precipitated by it. They said they don't have enough information on the Moderna vaccine to make that call.
74 2021-01-19 blood pressure decreased, heart rate increased, atrial fibrillation Typical expected side effects but were very SEVERE and UNable to function normally- headache, fatigu... Read more
Typical expected side effects but were very SEVERE and UNable to function normally- headache, fatigue, nausea, vomiting, diarrhea, Dizziness, Chills, Cold Sweats, Pain and soreness especially in lower back, and throat hurt when swallow. These persisted for 7+ days. The abnormal side effects included Yellow Vision that persisted for around 2 days, eyes felt hot, and heart rate shot up to 175 and then would drop to 70's. Went to doctor on 1/14/2021 and was found to have A-fib. had previously received a heart evaluation in 8/2020 and did not show any signs of this nor any signs on reading prior with an Apple watch. A-Fib is persisting and heart rate continues to be elevated and shoot up often even with Metapropol. As of this report on 1/20/2021 the heart rate is still varying from 80-150 and it normally runs around 50-60, has always been low. Blood pressure also dropped precipitously during this event and was as low as 80/50 so blood pressure medicines were discontinued to try and stabilize.
74 2021-01-19 fainting Syncope x2
74 2021-01-21 chest discomfort Patient developed mild lightheadedness, tight feeling in chest and anxiety while she was driving hom... Read more
Patient developed mild lightheadedness, tight feeling in chest and anxiety while she was driving home after her 15 min observation period. No rash, wheezing, itching. On return to the clinic she appeared mildly anxious. BP 160/75 pulse 65, regular. Lungs clear. No rash or urticaria. 15 mins later her symptoms remained very mild and bp 130/70 and hr 60. At 25 mins of observation she felt symptoms had improved and she was well enough to travel home.
74 2021-01-21 chest discomfort All information in this description are according to a narrative report submitted by Emergency Manag... Read more
All information in this description are according to a narrative report submitted by Emergency Management in post vaccine observation area of Covid Vaccine event. Patient reported experiencing chest heaviness post vaccination approx. 10:10am. patient relayed she had a history of syncope arrythmia and other cardovascular problems. was relocated to a private room an placed in Semi Fowler's position and attended to by a task force Registered Nurse. Registered Nurse took BP and Pulse and reported values of BP 181/64 and pulse rate of 49. Patient declined EMS transport for further evaluation and said her "chest discomfort was lifting." Narrative submitted by Emergency Management Observant notes no nasal flaring or rash/uticaria. Patient did relate that it was slightly difficult to catch her breath. RN from strike team and EMS personnel continued attending to the patient. Narrative states she refused transport and "after a short wait was ready to leave." Narrative further states "Patient further related she was feeling better and was encouraged to seek out medical attention by her cardiologist. Patient ambulated out of County Health Department without assistance."
74 2021-01-23 blood pressure increased Pt received first dose of Moderna vaccine and within a few minutes started developing a tingling fee... Read more
Pt received first dose of Moderna vaccine and within a few minutes started developing a tingling feeling in her mouth and elevated BP. Provided Cetirizine 10 mg then Benadryl 25 mg. SBP has been from 182 - 210; O2 sat 100% and have been monitoring her for the past hour and a half. Patient still has the tingling feeling and a feeling of rawness in her palate. discussed with allergy; refer pt to ED and check tryptase level to see if true allergy. This will affect whether she gets her second shot. Pt received first dose of Moderna vaccine and within a few minutes started developing a tingling feeling in her mouth and elevated BP. We initially gave her Cetirizine 10 mg then Benadryl 25 mg . SBP has been from 182 - 210; O2 sat 100% and have been monitoring her for the past hour and a half. She still has the tingling feeling and a feeling of rawness in her palate. discussed with allergy; refer pt to ED and check tryptase level to see if true allergy. This will affect whether she gets her second shot. Patient went to emergency room for observation and sent home without additional intervention.
74 2021-01-25 chest pain I advised her not to get her second dose of vaccine. Side effects from COVID vaccination. WED 20 JA... Read more
I advised her not to get her second dose of vaccine. Side effects from COVID vaccination. WED 20 JAN 8:50 am Shot received 9:15 am Nausea began 10:30 am Fever 99.9 Noon Suddenly overwhelmingly fatigued 1:00 pm Joint and muslce pains severe; difficult to move at all 2:00 pm Chills; bone chilling cold and chest pain Between 2- 7 pm All symptoms continue 7:00 pm Tongue swells and burns [like on fire] fire sensation goes down esophague to stomach; pain in stomach Fitful night: all symptoms continue thruout night except the chills Let up around 1 am THURS 21 JAN 7 am Tongue swelling down, but it's numb yet still burning all way down esophagus and the stomach burns still. Fatigue a little better; Joint pain and headache debilitating. Muscles cramping and extremely painful. Noon Sent message to Dr via online access 1 pm Vomiting occurred; rest of symptoms remain same with addition of new round of the chills 3:30 pm Vomiting ceased but nausea remains. Chills stopped, rest of symptoms remain. FRI 22 JAN 4am Vomiting returned, gatorade helps burning, but won't stay down. 7am Tongue no long swollen, burning is less. Tongue remains numb and no taste. Fever 99.6. Joint pain lessened by half. Headache intensity increased causing blurred vision. 10am Nausea only slight, can keep liquids down. Headache still intense. Fever 99.4 10:30am - 5pm Slept. 5pm Headache remains intense. Fever 99.6. Muscle and joint pains less severe. Nausea remains. Tongue numb but burning gone. 6pm Read Dr's message. 7pm All symptoms remain. 8pm Vomiting returns. Increase muscle and joint pains. Headache blinding. Fever 99.4 Slept on and off with no alleviation of symptoms SAT 23 JAN 4 am Woke with vomiting. Fever 99.2, headache worse. Tongue and esophagus and stomach burning back. 7am Nausea and muscle joint pains remain. But less. No fever. Headache less intense but vision still blurry Rest of day was able to move more freely and felt increasingly better as day unfolded. Had some solid food. SUN 24 JAN Appear to be back to normal except for the headache and vision blurriness. Tongue still numb and without taste. MON 25 JAN 7am Feeling just a little tired with slight headache and tongue numb. 9am Made app't with Dr for 3:30 today
74 2021-01-25 chest pain Sharp pain in chest for a minutes the night of the injection and then went away. The next morning, s... Read more
Sharp pain in chest for a minutes the night of the injection and then went away. The next morning, sharp pain in the stomach for a few minutes and then went away.
74 2021-01-26 heart rate irregular, heart rate decreased Eight days after my shot, I began to have an irregular heart rate, redness in my arm that went up in... Read more
Eight days after my shot, I began to have an irregular heart rate, redness in my arm that went up into my shoulder weakness, general fatigue, overall bodyaches, and some dizziness. My heart calmed down in a day, I also had a 24 hour temp of 101.4, which then hovered between 100and 99 degrees for the next five days along with continued weakness and achiness, and a lot of fatigue. It is now 27 January and I am just beginning to feel a little better.
74 2021-01-27 body temperature decreased MODERNA COVID-19 Vaccine chills, nausea, headache, muscle pain at injection site and into left shoul... Read more
MODERNA COVID-19 Vaccine chills, nausea, headache, muscle pain at injection site and into left shoulder blade, diarrhea, fatigue, loss of appetite, cough, low temperature
74 2021-01-28 heart failure patient started complaining of leg cramps and went back to his room, then left arm pain and body pai... Read more
patient started complaining of leg cramps and went back to his room, then left arm pain and body pain was given some nitro, patient vomited and a headache
74 2021-01-30 chest pain severe pain in left shoulder and chest area chills nausea
74 2021-01-31 blood pressure increased, blood glucose increased, oxygen saturation decreased Other: patient felt like she has her throat tightening and felt itching to the rear of her throat. ... Read more
Other: patient felt like she has her throat tightening and felt itching to the rear of her throat. Patient felt the itching start behind her ears and move to the back of her throat with some throat tightening. EMS called at 1448, patient signed ama
74 2021-01-31 loss of consciousness Approximately 84 hours after administration, I had severe vertigo when prone. This included a stra... Read more
Approximately 84 hours after administration, I had severe vertigo when prone. This included a strange sensation of my head floating and an odd sense of loosing consciousness. The vertigo was awful, and I could barely stand. This lasted each evening for about 6 night. It subsided in the morning, after I felt more stabilized in walking.
74 2021-01-31 palpitations pt states when she went to bed the day of her vax that her heart raced for about 30 minutes and she... Read more
pt states when she went to bed the day of her vax that her heart raced for about 30 minutes and she had severe chills for at least 12 hours. She said she felt so sick she got up to call an ambulance but did not. Pt stated she was very weak the next day after the vax. Pt has not contacted her PCP but is wakes up every day weak and shaky.
74 2021-02-01 chest discomfort The first one was some fullness in chest, and I left the clinic and I had some flushing in my face, ... Read more
The first one was some fullness in chest, and I left the clinic and I had some flushing in my face, nothing you wouldn't expect, had some light chills. Around four hours later I had some tingling in my feet and then began to progress up the leg, I began to realize I didn't have feeling in my feet so I began to walk around for about four to five hours, and began to get some relief and and laid down around 2 o clock in the morning, and when she woke up she had numbness in the bottom of her feet. It took about 36 hours for the numbness to go away.
74 2021-02-03 cerebrovascular accident on 1/31/2021 she had a small stroke and she is still getting therepy.
74 2021-02-04 cardiac arrhythmia, lightheadedness, loss of consciousness Passed out-was totally out for a couple of second; UTI; PVCs; very very dizzy; Vasovagal reaction; A... Read more
Passed out-was totally out for a couple of second; UTI; PVCs; very very dizzy; Vasovagal reaction; Arm was sore-not hurting much; A spontaneous report was received from a 74-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced dizziness, passed out, vasovagal reaction, urinary tract infection, premature ventricular contractions and arm pain. The patient's medical history included back problems with osteoarthritis in the spinal column neck and lower back. Products known to have been used by the patient, within two weeks prior to the event, included celecoxib and nortriptyline. On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient reported she got very dizzy and passed out. Her husband relays that she was totally out for a couple of seconds. She went to the emergency room and was diagnosed with a vasovagal reaction and urinary tract infection. Premature ventricular contractions were also discovered and was not known prior to this event. Patient reports a normal blood pressure of 114-120/75. Patient also stated her arm was sore the day after vaccine but not hurting much during her usual four mile walk. Treatment for the event included intravenous medications in the emergency room, cephalexin, and a heart monitor. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events passed out, dizziness, vasovagal reaction and arm pain were resolved. The outcome of the events, urinary tract infection and premature ventricular contractions were unknown.; Reporter's Comments: This case concerns a 74 year-old, female patient, who experienced events of dizziness, passed out, vasovagal reaction, urinary tract infection, premature ventricular contractions and arm pain. The events occurred the next day after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related. Further information have been requested.
74 2021-02-07 atrial fibrillation Atrial Fibrillation requiring ER visit and hospitalization. Treated in hospital with medication. Hi... Read more
Atrial Fibrillation requiring ER visit and hospitalization. Treated in hospital with medication. Hip and joint pain requiring doctor visit. Not resolved after one month.
74 2021-02-08 blood pressure increased Face got red about 15 minutes after shot. EMT came. Blood pressure elevated but went down and was de... Read more
Face got red about 15 minutes after shot. EMT came. Blood pressure elevated but went down and was declared stable. About 15 minutes took a Benadryl. About 15 redness began to recede and in a half an hour it was gone.
74 2021-02-08 cardiac arrest At 3pm resident was taken by EMS to local hospital. She had complained of respiratory distress (hx ... Read more
At 3pm resident was taken by EMS to local hospital. She had complained of respiratory distress (hx of COPD). Property manager reported that paramedic said she was "in cardiac arrest". We do not have more information at this time.
74 2021-02-08 chest discomfort Chest tightness, 5 minutes after getting Modena 2 dose
74 2021-02-08 pallor, fast heart rate, pulse abnormal Dizzy, nauseous, pale, cold extremities, weak pulse. BP 90/44, HR - 44. O2 sat 96-99%. Blood sugar 1... Read more
Dizzy, nauseous, pale, cold extremities, weak pulse. BP 90/44, HR - 44. O2 sat 96-99%. Blood sugar 127. Patient lay down, with feet elevated. Symptoms resolved.
74 2021-02-09 blood pressure increased Patient received 1st dose of Pfizer on 1/22/21 and today received 2nd dose, however, Moderna was giv... Read more
Patient received 1st dose of Pfizer on 1/22/21 and today received 2nd dose, however, Moderna was given in error. While in observation, pt experienced dizziness, BP elevated at 242/108. Patient reports not taking BP medications today.
74 2021-02-10 chest discomfort Pt c/ discomfort in throat, chest, and stomach. Pt decribes discomfort as "tightness." Pt stated pai... Read more
Pt c/ discomfort in throat, chest, and stomach. Pt decribes discomfort as "tightness." Pt stated pain level was 5 out of 10. Pt stated, "this feels like anxiety." Vitals were WNLs.
74 2021-02-10 heart rate increased About ten hours after taking the vaccine the nerves in my legs started jumping and quivering and my ... Read more
About ten hours after taking the vaccine the nerves in my legs started jumping and quivering and my heart started beating too fast and I couldn't relax. And the next morning I had a cramp in my leg that was the worst cramp I've ever had. There were stabbing pains in my body all through the day and I felt nervous.
74 2021-02-10 loss of consciousness, lightheadedness Patient reports she got up out of be early the next morning after receiving her COVID vaccine and to... Read more
Patient reports she got up out of be early the next morning after receiving her COVID vaccine and took 2 of her morning pills and then had an episode where she passed out for a few minutes and spilled the water down her clothing. She felt weak and tired after this episode and so went back to bed for several hours. Later that day she had another episode of feeling lightheaded as if she might pass out, while sitting at a hair salon waiting for her appointment, but did not actually pass out, just felt a wave of heat and slight nausea, but did not faint. She had one further near syncopal episode at home later that night when she also noticed she was a little "jittery" and noted a strange smell that the rest of her family did not notice. She also reports that she has had near syncopal episodes in the past and thinks she may have been a little dehydrated the day these incidents occurred.
74 2021-02-10 loss of consciousness 14 hours after the second dose I had chills, fever, body and head ache for 5-6 hours. Got up to get... Read more
14 hours after the second dose I had chills, fever, body and head ache for 5-6 hours. Got up to get something to eat and blacked out momentarily. Probably low blood sugar. Bumped head on floor.
74 2021-02-11 hypertension 1135 S/p vaccination reports "feeling headache in back of head w/associated anxiety and assessed ele... Read more
1135 S/p vaccination reports "feeling headache in back of head w/associated anxiety and assessed elevated BP Vitals assessed: BP 177/109 P90 O2 sat 97% ; 1154 BP 162/100 Transported by husband for further evaluation / treatment
74 2021-02-11 loss of consciousness At 11:50 am on Feb 9,2021,patient lost consciousness for 2-3 seconds and felt difficulty breathing, ... Read more
At 11:50 am on Feb 9,2021,patient lost consciousness for 2-3 seconds and felt difficulty breathing, and was unable to move body such as turning around when lying on bed. Patient also felt dry in the upper jaw. The above symptoms persisted till 12:20 pm. After short nap to 2:30 pm, Patient recovered from the above symptoms.
74 2021-02-15 heart rate increased, blood pressure increased Next day after vaccine, Feb. 6 - chills, fever (about 3 and a half degrees higher than normal), incr... Read more
Next day after vaccine, Feb. 6 - chills, fever (about 3 and a half degrees higher than normal), increasing pulse and bp 2 and a half days after vaccine, Feb. 8 - TWO rashes above elbow on right arm -- today, 8 days later, the rashes are worse -- have a virtual doctor's appointment tomorrow, Feb. 17
74 2021-02-15 heart rate increased, chest discomfort, blood pressure increased patient was being observed for 30 mins after injection and 20 mins within the observation patient st... Read more
patient was being observed for 30 mins after injection and 20 mins within the observation patient started to develop symptoms of: shortness of breath, left leg numbness and chest pressure. Blood pressure was at 207/97 and pulse was 113, no meds were given to patient. 911 was call and patient was transported to hospital at 12:50pm
74 2021-02-16 arrhythmia patient felt funny after shot. EMS was called vitals were taken BP 194/114 BG 143 HR 93. Cardiac Rh... Read more
patient felt funny after shot. EMS was called vitals were taken BP 194/114 BG 143 HR 93. Cardiac Rhythm Disturbance but patient refused additional evaluation and care. Released against medical advice.
74 2021-02-16 loss of consciousness passed out; urinated on herself; could not sleep; chills; fever; A spontaneous report was received f... Read more
passed out; urinated on herself; could not sleep; chills; fever; A spontaneous report was received from a consumer concerning a 74 year old female patient who received Moderna's COVID-19 vaccine and experienced loss of consciousness, chills, pyrexia, urinary incontinence and insomnia. The patient's medical history was not provided. Concomitant medication included unspecified blood pressure medications. On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. On 02-Feb-2021 the patient received the second of their planned doses of mRNA-1273 (Lot number 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 02-Feb-2020, the patient experienced chills, some fever, and could not sleep. On the morning of 03-Feb-2021, the patient passed out twice and urinated on herself. No treatment information was provided. Action taken with the mRNA-1273 in response to the events was not applicable. The outcome of the events of loss of consciousness, chills, pyrexia, urinary incontinence and insomnia were was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
74 2021-02-18 blood pressure increased, heart rate increased Itching, rash. rapid heartbeat, nausea, light headedness, elevated blood pressure. Received treatme... Read more
Itching, rash. rapid heartbeat, nausea, light headedness, elevated blood pressure. Received treatment at Urgent care ...EKG, steroid injection. RX Hydroxyzine, Prednisone, Ondansetron. Initial reaction appeared 10 days after vaccine. Currently experiencing intermittent out breaks of itching, numbness in lips and lower jaw and rash. When the itching begins its simultaneously in the same area right and left side. Example right thigh, left thigh etc.
74 2021-02-18 fainting Patient Syncope / Fainting unknown cause . Onsite EMS was called vitals were taken BP 132/90 HR 88. ... Read more
Patient Syncope / Fainting unknown cause . Onsite EMS was called vitals were taken BP 132/90 HR 88. Patient refused evaluation/care. Left aginst medical advice.
74 2021-02-19 heart rate increased Was awakened by Fitbit at 4 am heart rate was 137, normal heart rate 70. Lessened over time but cont... Read more
Was awakened by Fitbit at 4 am heart rate was 137, normal heart rate 70. Lessened over time but continuous fatigue for 2 days, no appetite, nausea
74 2021-02-20 chest pain 7 days later pt had a large local reaction then on 8 days after shots noticed 2 itchy red spots on b... Read more
7 days later pt had a large local reaction then on 8 days after shots noticed 2 itchy red spots on both sides of abdomen (pt states she gets this from time to time) -improved over a few days w topical steroids on day 9 after shot pt had chest pain only with lying down (went to ER) and was diagnosed w GERD a few days later pt had EGD which showed inflammation at GE junction (consistent w GERD)
74 2021-02-20 palpitations I broke out in a rash on face and legs, had extremely severe headaches, one day of incontinence, 2 d... Read more
I broke out in a rash on face and legs, had extremely severe headaches, one day of incontinence, 2 days of heart palpitations and shortness of breath. Also, I ate some peanuts and my throat swelled up. This is the FIRST TIME I have ever had a rash, incontinence, net allergy, or shortness of breath.
74 2021-02-20 fainting Felt lightheaded and dizzy after injection, then fainted
74 2021-02-21 heart rate increased PAIN, TENDERNESS AND SWELLING IN THE SAME ARM, HEADACHES, JOINT PAIN MUSCLE PAIN, CHILLS, NAUSEA AN... Read more
PAIN, TENDERNESS AND SWELLING IN THE SAME ARM, HEADACHES, JOINT PAIN MUSCLE PAIN, CHILLS, NAUSEA AND VOMITING AND FEVER. DIFFICULT BREATHING, WEAKNESS, FAST HEART BEAT, DIARRHEA
74 2021-02-22 cerebrovascular accident 8 days after vaccination - stroke/full right side of body paralyzed - clot buster drug at ER
74 2021-02-22 chest discomfort Presented to ER 2 days after COVID vaccine - SOB, chest heavy, thought she was having COPD exacerbat... Read more
Presented to ER 2 days after COVID vaccine - SOB, chest heavy, thought she was having COPD exacerbation, fever, cough, aches. EKG was normal, troponin was normal, CXR was normal/stable from past images. Patient took an extra dose of furosemide that day, and was on prednisone too.
74 2021-02-22 chest discomfort Constriction/ contraction of throat, then eyes and head and then chest. Felt like I was having a hea... Read more
Constriction/ contraction of throat, then eyes and head and then chest. Felt like I was having a heart attack with feeling of great pressure on chest. Last a little over an hour.
74 2021-02-22 heart rate increased, hypertension Head ache within 5 minutes of vaccine. Then along with headache, high blood pressure and rapid pulse... Read more
Head ache within 5 minutes of vaccine. Then along with headache, high blood pressure and rapid pulse. Temperature of 101.4 for several hours. Nausea has lasted for 4 days. Dizziness, weakness, lack of appetite and severe cold sores on upper lip. Soreness at vaccination site.
74 2021-02-23 chest discomfort, hypertension Shortness of breath, pressure on my chest, high blood pressure after 10 days of getting covid 19 ... Read more
Shortness of breath, pressure on my chest, high blood pressure after 10 days of getting covid 19 vaccine
74 2021-02-24 nosebleed Freezing cold and uncontrollable whole body muscular contractions, chills, started at around 8:00PM ... Read more
Freezing cold and uncontrollable whole body muscular contractions, chills, started at around 8:00PM on injection day, lasted about 2 hours Next morning , blood in nose at around 8:00AM. Single event.
74 2021-02-24 loss of consciousness Passed out because her sugar went down 1.30 and blood pressure went down; Shaking; Started having tw... Read more
Passed out because her sugar went down 1.30 and blood pressure went down; Shaking; Started having twinkle tongue, tongue started getting heavy; A spontaneous report was received from a consumer, a 74-year-old female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced started having twinkle tongue, tongue started getting heavy/ paresthesia oral, passed out because her sugar went down 1.30 and blood pressure went down/ loss of consciousness and shaking/tremor. The patient's medical history included was asthma from an unknown date. Products known to have been used by the patient, within two weeks prior to the event, included "advitrol inhaler" as an indication for asthma from an unknown date, levocetirizine dihydrochloride, "blood pressure pills" and "asthma medication" from an unknown date. On 18 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) and expiration date 03 Jul 2021 intramuscularly in her left arm for prophylaxis of COVID-19 infection. On 18 Jan 2021, approximately fifteen minutes after the vaccine, the patient started having twinkle tongue, tongue started getting heavy when she was on her way home. The patient had asthma so she took her medication and was okay. One week later on an unknown date, the patient passed out because her sugar went down 1.30 and blood pressure went down and was shaking which lasted for ten seconds. The patient mentioned something like that never happened before. The patient also mentioned she was having asthma issues so was waiting to see her allergies Doctor and was tested for covid-19 on an unknown date but had no result yet. Treatment information was not provided. The Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, started having twinkle tongue, tongue started getting heavy was considered as recovered on 18 Jan 2021. The outcome of events, passed out because her sugar went down 1.30 and blood pressure went down and shaking were unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. The patient reports that she passed out because her sugar went down and blood pressure went down. Further information has been requested.
74 2021-02-24 loss of consciousness About 6 hours after getting vaccine, I experienced extreme fatigue and passed out briefly on the bat... Read more
About 6 hours after getting vaccine, I experienced extreme fatigue and passed out briefly on the bathroom floor. When I came to, I had no recollection of passing out. It was only for a minute or two. I felt better and not as tired. I felt okay the next couple of days.
74 2021-02-24 palpitations About 8 p.m. the day of the vaccine Monday, I felt chilled, achy, fever, heart palpitations, until ... Read more
About 8 p.m. the day of the vaccine Monday, I felt chilled, achy, fever, heart palpitations, until about 4 a.m. when it subsided. still tired the next morning with my legs that ached. rested until 3 that afternoon. Ate light dinner. By Wednesday, I felt fine with no symptoms at all. Never needed to call a doctor.
74 2021-02-25 chest discomfort, blood pressure increased Following the vaccine, within 3 minutes her bottom lip got numb, then her tongue swelled and then he... Read more
Following the vaccine, within 3 minutes her bottom lip got numb, then her tongue swelled and then her eyes got fluttery uncontrollably, dizziness and weak. They had her lie down in a recliner. Her BP was 190/110. She did not need an EPI pen and within 15 minutes her lip became unnumb, and her tongue swelling receded, was still a little thick, and her face was swollen, was red and flushed. So they waited 30 minutes, her BP was not coming down, sent to the ER and observed for 3 hours and slowly her BP came down, all her other symptoms subsided and she was able to drive herself home. Last night 2/25/21 she had great itching on her chest, which has since stopped. Her tongue is still a little swollen, about 20% still feels thick. When she left the hospital her BP was 146/86. She has not taken anything for the symptoms just her regular routine medications. She did feel tired and spacy feeling, and has been off of work since Wednesday as she could not focus to go to work.
74 2021-02-25 chest discomfort Severe flu symptoms; feeling incapacitated; Gagging; Feeling like humming and buzzing (motor-like); ... Read more
Severe flu symptoms; feeling incapacitated; Gagging; Feeling like humming and buzzing (motor-like); Throat constriction/contraction; Eye/vision distorted and were constricted; Felt like head would explode; forehead and headache; Forehead/head constriction; Constriction/contraction of chest; A spontaneous report was received from a consumer, a 74-year-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced, feeling like humming and buzzing (motor-like), throat constriction/contraction, eye/vision distorted and were constricted, felt like head would explode, forehead/head constriction, constriction/contraction of chest, severe flu symptoms, feeling incapacitated, and gagging. The patient's medical history was not reported. No concomitant medications were reported. On 10 Feb 2021, prior to the onset of events, the patient received their second planned doses of mRNA-1273 (batch number: 030M20A), intramuscular for the prophylaxis of COVID-19 infection. The patient reported that she had adverse reactions after administering the vaccine around 2:00 on 10 Feb 2021. Later, the patient went to bed. On 11 Feb 2021, at midnight, the patient started feeling like that she was humming and buzzing from the waist up; throat was constricted and contracted; gagged a few times; vision/eyes were constricted and vision was distorted; forehead, and head ache felt constricted and felt like it was going to take off and was so tight. Later, it moved to chest, the constriction/contraction was so tight that and felt like someone was standing on it. The patient stated that these feelings were all above the waist and lasted for about an hour and ten minutes and just stopped on the same day. The next day on 12 Feb 2021, about six hours later, the patient had regular side effects which started about 10 hours after the shot. The patient was fine for about six hours then had severe flu symptoms and was feeling just incapacitated. The patient just got rid of these flu symptoms around 1 pm on the same day. The patient wanted to know if these were allergy symptoms. No treatment medication information was provided Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the events, feeling like humming and buzzing (motor-like), throat constriction/contraction, eye/vision distorted and were constricted, felt like head would explode, forehead/head constriction, constriction/contraction of chest, and gagging were recovered on 11 Feb 2021 and that of event severe flu symptoms was recovered on 12 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
74 2021-02-25 heart rate decreased, lightheadedness Pre-syncope
74 2021-02-25 fainting Had syncopal episode a week later, followed by weakness, fatigue, fogginess and balance impairment f... Read more
Had syncopal episode a week later, followed by weakness, fatigue, fogginess and balance impairment for three days.
74 2021-02-26 chest pain diarrhea, gastric distress, severe stomach cramps 12 days, severe headache 5 days, neck muscle spasm... Read more
diarrhea, gastric distress, severe stomach cramps 12 days, severe headache 5 days, neck muscle spasms, chesst pain, fever blister, still persists, doctor virtual visitii
74 2021-02-26 loss of consciousness Felt unwell on Wednesday but on Thursday morning I was getting dressed and intended to go back to be... Read more
Felt unwell on Wednesday but on Thursday morning I was getting dressed and intended to go back to bed since I did not feel well. Then came back to consciousness on the floor with a definite knot on my head from a fall. Crash was enough to wake my husband who said I was out about 5 minutes.
74 2021-02-27 chest discomfort, chest pain Severe chest pain & pressure/nausea/vomiting/body aches/headache.
74 2021-02-28 palpitations, hypertension lightheadness, palpitations, hypertension
74 2021-02-28 fainting, loss of consciousness After being very tired during afternoon of day following vaccination and about 29 minutes after eati... Read more
After being very tired during afternoon of day following vaccination and about 29 minutes after eating light supper, felt very dizzy and after a while head fell back and blacked out for a while. About 10 minutes later, stood up and walked about 4 meters to the refrigerator, grabbed onto handles and my husband rushed over and grabbed me as ir seemed I was going to fall. Sat me down in sofa, where after short? while I recovered. After getting up to go to refrigerator, no recollection of anything that followed. My internist?s diagnosis - síncope.
74 2021-02-28 troponin increased Takotsubo Cardiomyopathy, Acute Pulmonary Edema, Hospital Admission, Diuresis.
74 2021-03-01 atrial fibrillation Atrial fibrillation; A spontaneous report was received from a consumer, concerning herself, a 74-yea... Read more
Atrial fibrillation; A spontaneous report was received from a consumer, concerning herself, a 74-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medically important event of atrial fibrillation. The patient's medical history included heart surgery on an unspecified date in 2017. No concomitant medications were reported. On 05 FEB 2021, prior to the onset of event, the patient received their second of two planned doses of mRNA-1273 (batch number: 015L20A) for the prophylaxis of COVID-19 infection. On an unspecified date in FEB 2021, the patient experienced fast heart rate, felt weakness, dizziness, and had atrial fibrillation. No treatment medication information was provided. Action taken with second dose of mRNA-1273 in response to the event was not applicable. The outcome of the event, atrial fibrillation was not reported.; Reporter's Comments: Based on current information the event was assessed as unlikely related to mRNA-1273 vaccine, because of biological implausibility, no clear temporal association, and the patient's history of heart surgery which may promote atrial fibrillation episodes.
74 2021-03-03 blood glucose increased Day of injection- I had a sore arm. )n the day following the injection; started experiencing the f... Read more
Day of injection- I had a sore arm. )n the day following the injection; started experiencing the following s/s including arm soreness, body aches, headache, extreme fatigue, and fever ( my normal temperature is 96.4-97.4 F ) My temperature began to increase throughout the day until it reached 99.5 F about 7:30 pm . The most serious adverse reaction was the 18 hour spike in my blood glucose level which was elevated to the high glucose level . I ended up taking over 200 units of insulin in a 30+ hour period (normally would use this amount of insulin in a 36 hour period. I was unable to lower my blood glucose level from the range (200-300mmg) despite repeated doses of insulin during the time period of reaction (8:00am- 4:00 am).
74 2021-03-03 blood pressure increased Forehead felt "strange", slightly dizzy. After timer went off, stood and was dizzy. Was told to wa... Read more
Forehead felt "strange", slightly dizzy. After timer went off, stood and was dizzy. Was told to wait another 15 min and was given water and snack to elevate blood sugar in case it had dropped (I do not have diabetes or history of sugar drops). When I stood to leave, I stumbled in the hall and was told to stay and blood pressure was taken, which was elevated to about 170, which I had taken as I do daily, before I arrived and it was 119/60. This was done at hospital by nurse. It was taken again, and it had gone down to 145, and I felt well enough to leave and drive home. Stayed home, and vertigo was obvious, have had years ago, not recently, so I knew it was side effect.
74 2021-03-04 chest discomfort waited prescribed time and went to car but face felt tight and throat started to constrict. I looke... Read more
waited prescribed time and went to car but face felt tight and throat started to constrict. I looked in mirror and saw face had swelled. Went back into pharmacy and they called 911. EMT took me to ambulance to check vitals and this took about 45 minutes. They offered to take me to hospital but declined as had my husband suffering from cancer who also had shot and can't drive was waiting in the car. We drove 1/2 mile to friends home and waited to make sure felt ok to drive back. Drove home ok and have been feeling tired for 3 days but otherwise ok. Pharmacy followed up next day. Today feel a bit of pressure in the chest and have placed a call to my doctor but he has gone for weekend. I will go to emergency room if I feel worse and will call him on Monday to report incident.
74 2021-03-04 low platelet count altered mental status, acute on chronic thrombocytopenia, death
74 2021-03-05 palpitations After Injection performed errands, shopped. 5:00 returned home tired, weak slight headache. Ate cere... Read more
After Injection performed errands, shopped. 5:00 returned home tired, weak slight headache. Ate cereal, in bed by 7:00 pm Wed. night. Unable to sleep, extreme sweating (skin wet), chills joint pain (hips, lower back, wrists), rapid heart beat,headache, head swimming. nausea. Got up and had a piece of toast. and 1 xtra strength tylenol. Got up at 2:11 pm Thurs.called Iredell health services. Said ok to take Tylenol and Benedryl to sleep. Woke up at 5pm most smptoms gone.
74 2021-03-07 blood pressure increased Received vaccine on a Thursday. For the next 3 night I would get a dull headache with increased bl... Read more
Received vaccine on a Thursday. For the next 3 night I would get a dull headache with increased blood pressure. On Sunday morning I woke up with severe burning pain in my stomach up to & including in my esophagus plus all the normal reactions - dull headache, tired, weak, nauseated, chills, achiness & no appetite. The burning pain lasted about 12-14 hrs. I had no fever as well as no vomiting. continued to have other symptoms into the next day. After Monday I was back to normal.
74 2021-03-07 blood pressure increased By 7pm after vaccine symptoms started: Fever Tmax-100.8, chills, body aches, elevated BP:160/90 nor... Read more
By 7pm after vaccine symptoms started: Fever Tmax-100.8, chills, body aches, elevated BP:160/90 norm for Pt is 120/60 Taken Tylenol 650mg on 3/7/21 but fever returned today Hx of HTN but per Pt controlled (on medication for mgmt)
74 2021-03-07 fast heart rate, atrial fibrillation Upon arrival to the ED patient was tachycardic with rates in the 110s to 120s, febrile at 101.7, blo... Read more
Upon arrival to the ED patient was tachycardic with rates in the 110s to 120s, febrile at 101.7, blood pressure was 130s over 90s, requiring 2 to 3 L of oxygen to maintain oxygen saturations greater than 90%. She was noted to be in atrial fibrillation with RVR and EKG showed no acute ischemic findings. Troponin is negative, BNP elevated in the setting of known congestive heart failure with a EF in the 20 to 30% range. She received tylenol for fever, metoprolol x3 with adequate rate control achieved. Fever likely r/t to immune response generated by COVID-19 vaccine which she received earlier that day, normal white count, no infiltrate on CXR, lactate normal, blood culture x2 pending. She was given Lasix 40 mg. Patient admitted for further diuresis and rate control.
74 2021-03-08 chest pain Ultra sore arm(immediate). major bone and joint pain, nausea, loose bowels, very tired, neck pain, ... Read more
Ultra sore arm(immediate). major bone and joint pain, nausea, loose bowels, very tired, neck pain, foggy brain headache, fever 100 Went to bed. During the night woke up with chest pain. Slowly faded as next day passed.
74 2021-03-08 low blood oxigenation The patient developed myalgia, fevers, chills within two days, she developed hypoxia. She also had ... Read more
The patient developed myalgia, fevers, chills within two days, she developed hypoxia. She also had a dry cough that developed sometime between her first and second dose of vaccine. On March 5th she was admitted to the hospital with oxygen saturation of 82 on room air. She improved and was discharged on the fourth day.
74 2021-03-09 palpitations Immediate heart pounding, facial flushing and tingling, Doctor on duty came over and stayed with me... Read more
Immediate heart pounding, facial flushing and tingling, Doctor on duty came over and stayed with me for 30 minutes. She put devise in my finger that measures oxygen exchange and heart rate which was 105. She also got ice packs and a cold neck towel to put on. Gradually everything subsided, but I was unable to drive home so my husband did so. I developed a significant headache, so I went to bed when I arrived home.
74 2021-03-10 oxygen saturation decreased, chest discomfort Low oxygen and tightness in chest. Had 5 days in hospital for testing and nothing showed up. Got 2... Read more
Low oxygen and tightness in chest. Had 5 days in hospital for testing and nothing showed up. Got 2 vaccination and same reaction. My brother got his first vaccination, he had identical side effect and was advised not to get second shot. All were Moderna serum. My second shot was Lot#002A21A
74 2021-03-10 palpitations Pt reports heart palpitations, racing heart , and pounding heart even when at rest. Shortness of bre... Read more
Pt reports heart palpitations, racing heart , and pounding heart even when at rest. Shortness of breath and dizeness
74 2021-03-10 inflammation of the pericardium, fluid around the heart Pericarditis with large pericardial effusion with early tamponade
74 2021-03-11 chest pain Tuesday evening I started feeling itchy and creepy crawly under my skin. I had red spots and itchy a... Read more
Tuesday evening I started feeling itchy and creepy crawly under my skin. I had red spots and itchy and the more I itched it the itchier it got. I had hives under the bra line on my right side, hives on my right arm and on my stomach. My hands were getting swollen. I took Benadryl a few times. On Thursday I was starting to get chest pain so I went to the ER and I was getting more blotchy and my hands were more swollen. they kept me over night and I had a chest x-ray, CT Scan, an EKG and a stress test. all these tests were negative. My hands were so swollen that you couldn't see my knuckles.I developed hives under the blood pressure cuff and under the iv arm wrap.
74 2021-03-11 heart rate increased I had a slight anxiety feeling like fast heartbeat during my 15 minute wait time but not alarming. I... Read more
I had a slight anxiety feeling like fast heartbeat during my 15 minute wait time but not alarming. I left and continued my day but felt increasingly itchy and hours later developed a few hives. I took a Zyrtec and after a few more hours it all went away, For the next few days I had tiredness, joint pain and some chills. Completely better after a week.
74 2021-03-11 palpitations Saturday, 02/20/2021, 1 week after receiving the vaccination, I noticed my left shoulder was itching... Read more
Saturday, 02/20/2021, 1 week after receiving the vaccination, I noticed my left shoulder was itching. When I looked at it, there was sort of a blotchy crescent moon of pink color to the skin, not AT the injection site, but toward the front of the shoulder. The injection was toward the back of the shoulder, as I recall. There were no bug-bite-swollen-raised bumps. There was intense itching the next morning, 2/21, and the pink color was more of a 1 3/4" circle. Itching subsided but came back that afternoon. I applied a bit of hydrocortisone to the area and the itching subsided. The next morning, Monday, the area was more filled in with pink and there was a new peninsula of pink descending about 2" below the circle. It throbbed and itched when I first got up. Again there was another surge of itching in the late afternoon. I applied hydrocortisone twice. Tuesday there was no change in the rash or itching in the morning, but no second surge of itching in the afternoon. I messaged my Primary Physician's office and heard back that this could be a reaction to the vaccine, and that I should apply cold compresses to the area. I did. On Wednesday, the bottom of the rash was redder, but the top was fading.By Monday, March 1, no pink was visible.
74 2021-03-11 fainting, chest pain Patient received her first dose of the Mederna Covid vaccine at the Health unit on 03/10/21. Her fa... Read more
Patient received her first dose of the Mederna Covid vaccine at the Health unit on 03/10/21. Her family states she began experiencing nausea and vomiting last night (03/11/2021) and then started having chest pain at around midnight. This morning (03/12/2021) she was still experiencing vomiting and chest pain. She collapsed at approximately 07:30 and her family initiated CPR and EMS was called. She was brought the Hospital via Ambulance at 08:18 in cardiac arrest. The emergency department was unable to resuscitate her and she was pronounced dead.
74 2021-03-12 chest pain Head ache, chills, fever, bone ache, chest pains, exhaustion,nausea, swollen glands, rash, ear ache,... Read more
Head ache, chills, fever, bone ache, chest pains, exhaustion,nausea, swollen glands, rash, ear ache, dizziness, difficulty breathing, joint pain., ear aches, jaw and teeth aches.
74 2021-03-14 blood pressure increased, heart rate increased Serve days after the first dose. I noticed increase heart rate90 to120 and high BP 180/94 to 112/70.... Read more
Serve days after the first dose. I noticed increase heart rate90 to120 and high BP 180/94 to 112/70. Never had a heart issue or high BP. My BP went down to normal after several weeks and so did my pulse rate. After second shot several days late pulse rate 90-128. Bp stayed normal. I have some shortness of breath this time. I HAVE FALLEN IN THE LAST TWEEK TWICE FLAT ON MY FACE FOR NO RE on 3/15 Dr ordered ZIO for two weeks. My EKGs have always been normal and so have my pulse and BP.
74 2021-03-14 cerebrovascular accident Client claims she had a stroke d/t covid vaccination. She developed symptoms of weakness, nausea/vom... Read more
Client claims she had a stroke d/t covid vaccination. She developed symptoms of weakness, nausea/vomiting 5 days after receiving first dose of Moderna (February 4, 2021). On Feb. 5th client fell 3 times while at home and on Feb. 6th her daughter took her to the ED where she was diagnosed with having a CVA. Client was hospitalized 2/6/2021 thru 2/16/21. On 2/16 she was transfered to another hospital where she had another stroke and was discharged 2/23/2021. Please note client received her second covid vaccine on 02/27/2021. Writer called client's PCP office and spoke with RN. RN verified client was prescribed medications listed in box 9 prior to stroke. RN also stated client had diagnosis of hypertension prior to stroke but did not have any record of medications to treat hypertension on file prior to stroke.
74 2021-03-14 heart rate decreased, heart rate irregular, heart rate increased Heart issues- too fast-too slow, missing beats, skipping beats. Taken to ER by nurse on duty.
74 2021-03-14 hypertension Terrible headache; High blood pressure; Stiff neck; A spontaneous report was received from a consume... Read more
Terrible headache; High blood pressure; Stiff neck; A spontaneous report was received from a consumer in the concerning a 74-year-old female patient who experienced headache/MedDRA PT: headache, high blood pressure/MedDRA PT: hypertension and stiff neck/MedDRA PT: musculoskeletal stiffness. No medical history was reported. Concomitant medications include montelukast and hydrochlorothiazide. On 18-Feb-2021, this patient received their first planned dose of mRNA-1273 solution for injection, dosage not provided, (Lot/Batch number: 011L20A) in her right arm for prophylaxis of COVID-19 infection. On 18-Feb-2021, following the administration of the vaccine, the patient experienced a terrible headache, high blood pressure and a stiff neck. On 25-Feb-2021, she was transported to the Emergency Department by her friend because she was unable to drive. She was hospitalized and administered IV fluid, Ativan (lorazepam) and a "cocktail". She was discharged from the hospital on 26-Feb-2021. She has not recovered from the headaches. Her physician advised her not to get the second dose of the vaccine. Action taken with mRNA-1273 in response to the event was unknown. The outcome for the event headache/MedDRA PT: headache is not recovered. The outcome for the events high blood pressure/MedDRA PT: high blood pressure and stiff neck/MedDRA PT: musculoskeletal stiffness is recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
74 2021-03-14 hypertension Adverse Reaction to Covid Vaccine Approximately five minutes following injection of Covid Vaccine ... Read more
Adverse Reaction to Covid Vaccine Approximately five minutes following injection of Covid Vaccine patient began to voice concern that her neck, tongue, lips and throat were beginning to "feel funny" She was flushed hot and anxious. She denied SOB, throat tightness or dizziness. BP 142/78 PO 97 pulse 87. Ice pack applied. Temp. 98.2 which client states is above baseline of 97. Benadryl 25 mg PO administered per protocol at 0905. Client continued to voice concern that S/S may progress. EMS notified and dispatched. S/S began to improve however client continued to voice concern about itchiness in the scalp and tongue irritation. No visible signs of swelling noted. EMS left. A second benadryl 25 mg was administered per protocol at 0940. Client verbalized desire to return home with plan to go to ER if S/S worsened; my contact information was provided. Patient left with her husband. Dr. on call for PCP was notified of above. 3/14/2021 Reached out to patient she stated that she is doing very well today. She had to take Benadryl twice yesterday afternoon. Encouraged her to discuss concerns with PCP.
74 2021-03-14 fainting Clammy and faint. 2 hours later numbness on left side of face and headaches that came and went. Las... Read more
Clammy and faint. 2 hours later numbness on left side of face and headaches that came and went. Lasted for about 2 hours.
74 2021-03-15 nosebleed Patient called to report that she had a very bad nose bleed the morning of 3/16/21. She couldn't get... Read more
Patient called to report that she had a very bad nose bleed the morning of 3/16/21. She couldn't get it to stop at first and was afraid it would not. She reported never having had a nose bleed in the past.
74 2021-03-15 hypertension 2/15-2/19 nightly headaches increasing in intensity each night. 2/20-2/25 nightly headaches with st... Read more
2/15-2/19 nightly headaches increasing in intensity each night. 2/20-2/25 nightly headaches with stabbing pain in left eye 2/26.. 2/22- saw Dr. /had CT. 2/24-returned to Dr. and was sent to ER due to high BP. Hospital admission that evening. 2/26 Steroid treatment stopped headaches and eye pain. 2/27 released from hospital after BP was <160. Diagnosis-migraines possibly triggered by vaccine. Pain/nausea elevated BP and decreased food intake which caused low blood sodium levels. IV treatments to increase sodium and lower BP. Dizziness from low sodium and high BP created fall risk, so bed had alarm. Bed confinement necessitated daily injections to prevent blood clots. Twice daily blood tests done to monitor sodium and potassium levels + kidney function.
74 2021-03-15 hypertension extreme exhaustion, sleepiness, shortness of breath,loss of appetite, dizziness and cognition proble... Read more
extreme exhaustion, sleepiness, shortness of breath,loss of appetite, dizziness and cognition problems
74 2021-03-15 blood clot Ocular stroke. A black curtain dropped down over right eye. Went to ER on the 28th, and was admitted... Read more
Ocular stroke. A black curtain dropped down over right eye. Went to ER on the 28th, and was admitted. Had a blood clot in the right eye. Carotid artery right side did not have stenosis, they do not know why she had a stroke. Doctor can't say that it was caused by the vaccine. She now has a permanent blind spot in right eye.
74 2021-03-16 palpitations awakened with racing heartbeat-lasted for a few hours, headache-ongoing after 8 hours (Heart racing ... Read more
awakened with racing heartbeat-lasted for a few hours, headache-ongoing after 8 hours (Heart racing stopped) headache lessened some by tylenol
74 2021-03-17 blood pressure decreased 1132: After 30 min observation patient notified the observer in the waiting room that she was exper... Read more
1132: After 30 min observation patient notified the observer in the waiting room that she was experiencing lightheadedness and dizziness. She also described a burning sensation down her right arm , which is the arm that the vaccine was administered in. Patient was brought to room 1 , vitals B/P 180/74 SPO2 97% , heart rate 70 11:00 am Patient was given orange juice 4 oz and did report an improvement in symptoms. APN and doctor called to the vaccine clinic to observe the patient. Vitals as follows: 11:02 am B/P 160/94, heart rate 69 11:03 am B/P 165/77 11:07 am B/P 174/72 11:10 am B/P 175/80 SPO2 98% , heart rate 70 Doctor did manually take the patients B/P at 11:13 am 154/82, Doctor cleared the patient for release to home with orders to take her blood pressure and that we would call to check on her in 2 hours (1330 pm) . Final vitals before release from the clinic are as follows: 11: 30 B/P 170/66 Heart Rate 68 SPO2 97% Patient escorted to her vehicle registered nurse and nursing student 1751 provider noted: I called the patient and checked on her just a few moments ago. She reports that she has been feeling well, her blood pressure has come down in the 120s over 60s. She denies any concerns. She was advised to contact office for any questions or concerns.
74 2021-03-17 chest discomfort, hypertension, heart attack She had the injection, had the usual side effects, did not have fever, nothing out of the ordinary. ... Read more
She had the injection, had the usual side effects, did not have fever, nothing out of the ordinary. Then on Sunday 2/28/21 at approximately 8:00 AM she started having pressure in her chest, radiating to her left shoulder, left neck, left arm and across the shoulder blades. She never had any heart issues or blood pressure issues. Went to the ER and her cardiac enzymes were elevated, and her EKG's indicated she was having a heart attack. She was lift flighted to the next major hospital and had a cardiac Cath which found a 25% blockage in one spot. They are stating that they do not know what caused this. When she informed them that she had the vaccine they told her to report this information. Her BP was high in the hospital and did not come down much during the hospital stay. She was put on Cardizem, and Crestor, as well as started on 81mg aspirin. She is now under the care of a cardiologist, but has recovered from the initial reactions.
74 2021-03-17 chest discomfort, palpitations Patient developed "heart palpitations following Moderna injection. VS 141/83, 95%, 64. Denied any sh... Read more
Patient developed "heart palpitations following Moderna injection. VS 141/83, 95%, 64. Denied any shortness of breath. Reports "pinching" in chest but states this is not new and has "been going on for years". Denies any numbness or tingling. Ambulated with patient to exit. No assistance needed. Answers appropriate. Advised to call her PCP with any worsening of symptoms.
74 2021-03-18 atrial fibrillation weakness, dizziness. admitted to hospital and dx with new onset Afib
74 2021-03-18 loss of consciousness After I had my first dose vaccine I experienced swelling to my arm. Two days afterwards, I was invol... Read more
After I had my first dose vaccine I experienced swelling to my arm. Two days afterwards, I was involved in a MVA. I blacked out completely and had loss of consciousness. I do not know if the vaccine is related to me have had loss of consciousness at the time of my motor vehicle accident. I was in the hospital from 01-11-2021 to 01-12-2021.
74 2021-03-18 heart attack Patient admitted same day as dose 2 of vaccine for an MI
74 2021-03-19 palpitations Intense chills, racing heart for 8 to 10 hours, nausea, headache, fatigue, general malaise (urinated... Read more
Intense chills, racing heart for 8 to 10 hours, nausea, headache, fatigue, general malaise (urinated on the bathroom floor).
74 2021-03-20 loss of consciousness Woke Friday am with no control over my bladder and violent shaking of my legs with pain radiating fr... Read more
Woke Friday am with no control over my bladder and violent shaking of my legs with pain radiating from my hips. Fever of 100.9.Couldn't move my legs or sit up and eventually fell to the floor on my back. Spent over an hour using my elbows to scoot across floor. Hit head 3 times and passed out for awhile. Got help and went to the ER. CT showed no concussion. Pain reliever helped and after several hours was discharged with instructions to use a walker. Used walker for 2 days and then cane. Still have leg pain on occasion and now the Vertigo is worse. Also had reaction to first vaccine but just high fever, 101.4 and aches.
74 2021-03-21 heart attack HEART ATTACK REPORTED BY RELATIVE OF PATIENT. PATIENT IN HOSPITAL AS OF YESTERDAY 03/21/2021
74 2021-03-21 fainting Faint; Dizzy; Slight reaction; Very tired; A spontaneous report, was received from a consumer (patie... Read more
Faint; Dizzy; Slight reaction; Very tired; A spontaneous report, was received from a consumer (patient), a 74 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced faint (syncope), dizzy (dizziness), slight reaction (vaccination complication) and very tired (fatigue). The patient's current conditions included atrial fibrillation, back trouble and peripheral neuropathy (diagnosed years ago). The patient had medication allergies to pain medications and non-steroidal anti-inflammatory drugs (NSAIDs). Concomitant products included digoxin, carisoprodol, metamizole sodium and warfarin sodium. On 09-FEB-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 09FEB--2021, after receiving the vaccine, the patient had a slight reaction and became very tired, faint and dizzy. The patient's husband helped her to bed. The next morning on 10-FEB-2021, the events were resolved. The patient was scheduled for next Moderna vaccine (second dose) on 09-MAR-2021. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to events was unknown. The outcome of the events, faint, dizzy, slight reaction and very tired was recovered/resolved on 10-FEB-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
74 2021-03-22 anaemia, platelet count decreased, haemoglobin decreased Since February, I feel nauseous all day (I do not throw up), I can eat very little, many times a day... Read more
Since February, I feel nauseous all day (I do not throw up), I can eat very little, many times a day and lost weight. My weight before the vaccine was 116 lbs, now it is 110 lbs. I am of a small frame, 5 ft. At the time, I was unable to contact my physician to report the problems before I receive the second dose that was scheduled on March 10, 2021, due to death in his family. I wrote to the Physicians who were communicating with me about my appointment and reported the above symptoms. An Administrative Assistant responded that these symptoms are not known to be associated with the vaccine.On March 16, 2021 I was able to get an appointment and on that date he did a series of blood tests. The blood tests
74 2021-03-23 hypertension The injection was at 1p.m. That night I woke up at 2 a.m. with an extreme headache, facial flushing... Read more
The injection was at 1p.m. That night I woke up at 2 a.m. with an extreme headache, facial flushing and a feeling of not being well. BP was taken later and was 205/155-59. My normal is 117/70. Surprisingly, this high BP did not dissipate on it's own. IT lasted a total of 26 days but gradually the highs lowered. Headaches woke me at night. (Facial flushing with high BP was first noted by a neurologist years back and I was found to have surges of nor-epinephrine. I was tested for a pheochromocytoma but that was negative. I normally have small self limiting surges for 4-5 hours once every month or two. I do not need medicine with those. I have longer surges after steroid injections I get for bursitis.
74 2021-03-24 anaemia, haemoglobin decreased Patient developed severe anemia, sob, weakness requiring 2 units of PRBC and hospitalization for sev... Read more
Patient developed severe anemia, sob, weakness requiring 2 units of PRBC and hospitalization for several days
74 2021-03-24 palpitations, fainting 03/14/2021 Horrible head ache, nausea, dizzy, exhaustion, brain fog, confused, chills, heart poundin... Read more
03/14/2021 Horrible head ache, nausea, dizzy, exhaustion, brain fog, confused, chills, heart pounding, fainted. Went to ER by ambulance. The patient still has bouts of a pounding rapid heart beat & brain fog. She states that her head feels full with these bouts.
74 2021-03-24 pulse abnormal, heart rate increased headache,nausea, rapid heartbeat pulse 138
74 2021-03-24 fainting I fainted, along with having fever, chills, headaches, nausea and swollen sore arm. I hadn't read of... Read more
I fainted, along with having fever, chills, headaches, nausea and swollen sore arm. I hadn't read of people fainting, so I wanted to let you know. I only fainted once and I was recovered by March 25.
74 2021-03-25 palpitations Palpitations 5 min after injection (up to 105 bpm) and lasting 15 min. Following day: Fever 101 de... Read more
Palpitations 5 min after injection (up to 105 bpm) and lasting 15 min. Following day: Fever 101 degrees, sore right arm, fatigue. Sore arm about 5 days. Palpitations also occurred after 1st dose on January 23, 2021 and lasted about same amount of time. Other than sore arm for just one day, no other symptoms
74 2021-03-25 sinus rhythm, atrial fibrillation, fast heart rate, palpitations Patient is a lovely 74-year-old female with a long history of PACs and hypertension. Her blood pres... Read more
Patient is a lovely 74-year-old female with a long history of PACs and hypertension. Her blood pressure has been getting a little bit worse over the past years. She was admitted through the ER with 1st known episode of atrial fibrillation and hypertension. She reports that on 02/02 she received her 2nd COVID vaccine. She had joint achiness and a low-grade temperature. She rested the following day but then on 02/04 went for her usual hour long runs/hike. She did not feel very well during exercise and started have a headache and some increasing palpitations. Later that evening she was watching TV and started to have significant tachycardia that was irregular. Symptoms persisted and she presented to the ER which sound to be in AFib with rapid ventricular response with a blood pressure of 215/158. She was started on a diltiazem drip and has converted to sinus rhythm with PACs. Blood pressure has improved significantly. Troponin negative x2. Her last evaluation at a Heart facility was in 2017. She had an echocardiogram in 2014 with normal EF, mild MR and mild TR with normal estimated PA systolic pressure. She denies chest pain or dyspnea. No history of syncope. Sometimes with palpitation she does get lightheaded. She gets occasional lower extremity edema that seems dependent in nature. She is still having palpitations but recognizes that she is no longer in atrial fibrillation as that was more severe in terms of symptoms of tachycardia.
74 2021-03-26 lightheadedness DAY ONE, Metallic taste in mouth, immediately after vaccine, over in minutes. DAY ONE, Vagal bod... Read more
DAY ONE, Metallic taste in mouth, immediately after vaccine, over in minutes. DAY ONE, Vagal body flush, sudden weakness, immediately after vaccine, over in minutes. DAY TWO, 3:30 p.m., freezing chills. Fever quickly rose to 104, took 2 Advil and 2 Tylenol, fever gone by 7:30 p.m. Continued chills, very weak and tired. Developed COVID arm, red, splotchy, warm to touch, swollen, hard, very large area. DAY THREE and DAY FOUR, very weak, easily exhausted, no energy. COVID arm. DAY FIVE, much improved, still a little tired but able to drive and go to store. Still have COVID arm.
74 2021-03-27 blood pressure increased, body temperature decreased, heart rate increased By March 6, fever, increased blood pressure and pulse, regular headache, upset stomach -- The fever... Read more
By March 6, fever, increased blood pressure and pulse, regular headache, upset stomach -- The fever subsided on March 7 but then came back that night. I also developed ocular migraines (not a regular headache) on March 7 and 8. These include aura and interrupted vision. I do get this kind of migraine from time to time. My temperature is also running a little low.
74 2021-03-28 chest discomfort 1st dose Moderna vaccine, had covid in Dec that lasted until mid January and the vaccine caused the ... Read more
1st dose Moderna vaccine, had covid in Dec that lasted until mid January and the vaccine caused the same symptoms as covid, extreme headache, sinus build up, respiratory discomforts, discomfort in limbs, fatigue, weak on feet, dizziness, muscle pain, vomiting, diarrhea, joint pain, ear buzzing, and I'm supposed to get 2nd dose in 19 days and I don't know if I can tolerate it.
74 2021-03-29 low blood oxigenation Approximately 3-4 days after her first immunization, patient became ill. She contacted our triage l... Read more
Approximately 3-4 days after her first immunization, patient became ill. She contacted our triage line 6 days after immunization with report of chills and weakness. She presented to Medical Center Emergency Room where she was admitted for hypoxia. She was subsequently diagnosed with COVID by PCR. She developed respiratory failure, worsening kidney failure necessitating dialysis, c diff colitis, GI bleed, and acute heart failure. Despite maximal efforts by the ICU/hospitalist team and specialists her conditioned worsened. She was made comfort care and died on 2.26.21
74 2021-03-30 cerebral haemorrhage Internal brain bleeding; Bad headaaches; A spontaneous report was received from a consumer concernin... Read more
Internal brain bleeding; Bad headaaches; A spontaneous report was received from a consumer concerning a 74-year-old, elderly female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bad headaches/headache and internal brain bleeding/cerebral haemorrhage. The patient's medical history was not provided. Past medication included unspecified blood thinner. Concomitant product use was not provided by the reporter. On an unspecified date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. On 18 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. On an unspecified date, after second dose of vaccine, the patient bad headaches due to which patient had an MRI (magnetic resonance imaging) which showed internal brain bleeding. The event led to hospitalization. She had been in and out of the hospital two more times before since getting a shot. No treatment medication was reported. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, bad headaches and internal brain bleeding was not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
74 2021-03-30 lightheadedness evaluated for chief complaint of lightheadedness
74 2021-03-30 fast heart rate tachycardia heart valve regurgitation observed on echcardiogram in March 2021 (not present on ecocar... Read more
tachycardia heart valve regurgitation observed on echcardiogram in March 2021 (not present on ecocardiogram done in June 2020) wildly vacillating oxygen saturation from 99 to 83 (after very limited exertion, such as emptying dishwasher) wildly vacillating pulse from 70 - 152 (after very limited exertion, such as emptying dishwasher) shortness of breath extreme fatigue and exhaustion no endurance poor sleep poor appetite Absolutely NONE of these symptoms present prior to second Moderna injection
74 2021-03-31 heart flutter Tip of tongue burning; Inside of lip red burning along the gum line; Inside of lip red burning along... Read more
Tip of tongue burning; Inside of lip red burning along the gum line; Inside of lip red burning along the gum line; Part of the rash is smooth and part of it has little bumps; hot on left arm around the injection site/the area is warm to the touch; left arm rash/rash at the injection site, felt like an insect bite; The area is red; Itchy; Felt rush fluttering of heart, could be nerves; Could be nerves; A spontaneous report was received from a consumer concerning a 74-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rush fluttering of heart, could be nerves/cardiac flutter, tip of tongue burning/tongue discomfort, inside of lip red burning along the gum line/oral discomfort/gingival discomfort, left arm rash, rash at the injection site, felt like an insect bite/vaccination site rash, hot on the left arm around the injection site, the area is warm to the touch/vaccination site warmth, part of the rash is smooth and part of it has little bumps/rash papular, the area is red/vaccination site erythema, itchy/vaccination site pruritus and could be nerves/nerve injury. The patient's medical history, was not provided by the reporter. Concomitant medications reported included clonazepam, vitamin D3, curcumin, acetyl salicylic acid, famotidine, estradiol patch, vitamins, coq 10, and propranolol. On 19 Feb 2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 19 Feb 2021, 5 minutes after receiving the vaccine, while she was in the observation room, she felt a little rush and a flutter in her heart. She was not sure if that was due to her nervousness and anxiety in receiving the shot. That the feeling subsided within 15 minutes. On 28 Feb 2021, 9 days after receiving the vaccine, she experienced a rash at the injection site. It first felt like an insect bite and started to itch. When she saw the rash, it covered a larger area. The area is warm to the touch and red. The rash is smooth and part of it has little bumps. When she runs her hand over the rash, it seems to get redder. The rash seems to be getting better than when it first started. The patient also experienced tip of tongue burning, inside of lip red burning along the gum line. Treatment for the events included gargling warm water and salt, curcumin, and eucalyptus cream. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, rush fluttering of heart, could be nerves was reported to be resolved on 28 Feb 2021. The outcome of the events tip of tongue burning, inside of lip red burning along the gum line, hot on the left arm around the injection site, the area is warm to the touch, part of the rash is smooth and part of it has little bumps, the area is red, and itchy were unknown. The outcome of the event left arm rash, rash at the injection site, felt like an insect bite was reported to be recovering.; Reporter's Comments: 74 Y/O F had serious unexpected cardiac flutter with "nerves" and NS unexpected tongue discomfort, oral discomfort, gingival discomfort, rash popular, vaccination site warmth and expected vaccination site rash, vaccination site pruritus, vaccination site erythema. Cardiac flutter 5 minutes after first dose. Cardiac flutter resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
74 2021-03-31 pulmonary embolism Pulmonary embolism; A spontaneous report was received from a consumer who is a 74-year old, female w... Read more
Pulmonary embolism; A spontaneous report was received from a consumer who is a 74-year old, female who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed a pulmonary embolism. The patient's medical history included hypertension, obesity, chronic obstructive pulmonary disease, lung cancer, bladder cancer, and meningioma. Products known to have been used by the patient, within two weeks prior to the event, included olmesartan, vitamin D3, calcium carbonate, and nebivolol hydrochloride. On 08-JAN-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 04-FEB-2021, the patient was diagnosed with a pulmonary embolism. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, pulmonary embolism is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
74 2021-04-01 chest discomfort I felt an unusual feeling in my chest like a bubbling feeling and I went to the doctor. I sometimes ... Read more
I felt an unusual feeling in my chest like a bubbling feeling and I went to the doctor. I sometimes have gastric issues and this felt different than normal. I went to the doctor and they took blood work. I was told that my Pancreatic enzymes were very high and I was told to go the emergency room. After testing there was no problem with my Pancreas, and I did not feel really sick. I got the second dose of the vaccine and I had fever and chills the next day. I didn't have any more of the chest feeling like the first time.
74 2021-04-01 excessive bleeding Bleeding at injection site, bruise the size of quarter with rash developing after a day down the arm... Read more
Bleeding at injection site, bruise the size of quarter with rash developing after a day down the arm the size of a playing card.
74 2021-04-01 heart rate increased, atrial fibrillation Heart beating very fast, out of control. Later diagnosed with A - Fib
74 2021-04-01 fainting syncope without prodrome within 24 hours of administration
74 2021-04-01 fainting I was very achy felt like the flu for a day and 1/2. On that Saturday I fainted I woke up crawled i... Read more
I was very achy felt like the flu for a day and 1/2. On that Saturday I fainted I woke up crawled into the room passed over. I have been to the Ear,Nose & Throat doctor doesn't know if this is from vaccine or ear inflammation. I also followed up Cardiologist and Neurologist waiting on the results.
74 2021-04-03 blood pressure increased Late Saturday afternoon starting not feeling well. Sunday didn't feel good , cold and then I started... Read more
Late Saturday afternoon starting not feeling well. Sunday didn't feel good , cold and then I started coughing, asthma, and none of my usual meds helped. Late evening Sunday the fever broke, but not the coughing and this continued until Thursday morning. I have a massage therapist friend that thought she could help the lymphatic system with a massage and it did. I saw her again Saturday morning and the cough stopped. Sunday afternoon started a UTI infection and had to get antibiotics on Thursday and still have to get more since it didn't clear up. In the meantime my whole body ached and when I went to the dentist my BP was elevated. 4/2 I felt the worst of all the days since the shot. On the 3rd started feeling better and yesterday my BP was good and just took it and it up again, but hadn't been elevated prior to the shot. In fact I felt fairly well prior to the shot. Based on how I've felt since the shot I'm electing not to take the 2nd shot.
74 2021-04-03 cerebrovascular accident Stroke
74 2021-04-04 blood glucose increased Caused my blood sugar to run very high. Stated within 2 hours following the second shot and continue... Read more
Caused my blood sugar to run very high. Stated within 2 hours following the second shot and continued for 3 days. Every time I ate anything my blood sugar would jump to the 300+. I would have to aggressively up my insulin amount to control. I am still having high blood sugars following meals.(I have been an insulin dependent diabetic for 30 years and have always kept my A1C at 7 or below.) It does not seem to matter what I eat the result is a very fast rise in my blood sugar. I wear a Dexcom PDM and use OmniPod pump to manage my diabetes.
74 2021-04-04 cerebrovascular accident Stroke
74 2021-04-04 fainting Nausea, sweating, chills, then fainted. Woke up on kitchen floor. Felt sick all day. Next day muc... Read more
Nausea, sweating, chills, then fainted. Woke up on kitchen floor. Felt sick all day. Next day much better and able to eat normally.
74 2021-04-05 blood pressure increased I had my first Moderna vaccine on 2/18/2021 ...started having breathing problems off & on with heart... Read more
I had my first Moderna vaccine on 2/18/2021 ...started having breathing problems off & on with heart rate of 120...extremely weak...dizziness...shaking about 3 days after vaccine. I went to Urgent Care on Sunday 2/28/2021...they gave me rapid Covid test & 3 day Covid test...both turned out negative. Listened to heart...blood pressure was very high...Nurse Practitioner thought it was cardio & sent me to ER. They did testing...blood, urine, EKG, Xray. I went to my family doctor & he suggested not getting the 2nd shot. I have appt. with Cardiologist.
74 2021-04-06 chest discomfort Couldn't get up to do anything and stayed on the couch; Temp of 99.8 and 99 F; Arm was sore; Really ... Read more
Couldn't get up to do anything and stayed on the couch; Temp of 99.8 and 99 F; Arm was sore; Really sleepy, slept all night; Chest was tight; Dizzy/Lightheaded; Throat was sore; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest was tight) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included GABAPENTIN, SPIRONOLACTONE, DULOXETINE, MELOXICAM, ATORVASTATIN, VERAPAMIL, MULTIVITAMINS [VITAMINS NOS], FOLIC ACID and MAGNESIUM for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest was tight) (seriousness criterion medically significant), DIZZINESS (Dizzy/Lightheaded), OROPHARYNGEAL PAIN (Throat was sore) and SOMNOLENCE (Really sleepy, slept all night). On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and PYREXIA (Temp of 99.8 and 99 F). On 06-Mar-2021, the patient experienced FATIGUE (Couldn't get up to do anything and stayed on the couch). At the time of the report, CHEST DISCOMFORT (Chest was tight), DIZZINESS (Dizzy/Lightheaded), OROPHARYNGEAL PAIN (Throat was sore), PAIN IN EXTREMITY (Arm was sore), SOMNOLENCE (Really sleepy, slept all night), PYREXIA (Temp of 99.8 and 99 F) and FATIGUE (Couldn't get up to do anything and stayed on the couch) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 99.8 f (Inconclusive) 99.8 F and 99 f (Inconclusive) 99 F. Treatment information were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
74 2021-04-06 heart rate decreased, fainting Patient received the COVID-19 Moderna vaccine on 4/6/21 at 2:18pm. The following day on 4/7/21 at ab... Read more
Patient received the COVID-19 Moderna vaccine on 4/6/21 at 2:18pm. The following day on 4/7/21 at about 2:15pm, the patient was shopping in the store and fainted at self checkout. An associate caught her before she hit the ground and lowered her down gently. Store management alerted the pharmacy and I, the pharmacy manager, went to assist the patient. She said she felt fine yesterday after receiving the vaccine but did not feel well this morning. An ambulance was called and EMS arrived at the scene. One of them reported that her pulse was low but did not report a specific number. EMS took her to a local hospital. I spoke to her husband and let him know that I would call to follow up with them tomorrow.
74 2021-04-06 loss of consciousness The morning after my 2nd shot, I got up to use the restroom. I took an item out of the bathroom va... Read more
The morning after my 2nd shot, I got up to use the restroom. I took an item out of the bathroom vanity under the sink and then without feeling dizzy and not knowing that it was going to happen, I passed out and landed on the bathroom floor. I've never had this happen to me before and so I am questioning if it could be because of the covid shot that I had less than 23 hours earlier. I ended up with 10 staples in my head with the 2 1/2 inch injury on the back of my head. Thankfully I didn't break any bones nor have any other adverse problems. The emergency room did several tests, and they couldn't find any reason for it to happen.
74 2021-04-07 excessive bleeding spontaneous bleeding from L hand pinky cuticle and from R thumb proximal phalanx volar aspect
74 2021-04-07 heart rate decreased Chills starting at 3:00 am on 04/08/2021, body aches, Heart beat of 106 at 7:30 am after lying in b... Read more
Chills starting at 3:00 am on 04/08/2021, body aches, Heart beat of 106 at 7:30 am after lying in bed. Blood pressure of 84/59 at 11:00 am and heart beat down. Feeling weak and very poorly and very tired.
74 2021-04-07 hypertension Blood pressure over 200; Could not see very clearly; This spontaneous case was reported by a consume... Read more
Blood pressure over 200; Could not see very clearly; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure over 200) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HYPERTENSION (Blood pressure over 200) (seriousness criterion hospitalization) and VISUAL IMPAIRMENT (Could not see very clearly). In March 2021, VISUAL IMPAIRMENT (Could not see very clearly) had resolved. At the time of the report, HYPERTENSION (Blood pressure over 200) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
74 2021-04-08 haemoglobin decreased, blood pressure increased, enlargement of the heart 3/8: Admitted to hospital dx chest pain; 3/9 transferred to a different hospital, dx gallbladder ne... Read more
3/8: Admitted to hospital dx chest pain; 3/9 transferred to a different hospital, dx gallbladder necrosis. Hospital course: 74 y.o. female admitted on 4/8/2021 for abdominal pain. Notable PMHx: aortic valve replacement, HTN On morning of admission, patient woke up with severe epigastric pain. Describes pain as a pressure. Has had vomiting. Had bowel movement after pain started. Patient came to the emergency room. Patient received an antiemetic and Demerol. Patient has continued to have pain in got a dose of morphine as well. Pain eased some but was still 7/10. In the ER, blood pressure was very elevated with systolic in 200s. Cardiac enzymes negative. EKG look good with normal sinus rhythm. Patient has aortic valve replacement and is on Coumadin with INR goal of 2.5-3.5. INR was elevated at 4.3. D-dimer was negative. Amylase and lipase negative. Creatinine normal at 0.9. Chest x-ray done which showed no acute disease. On the floor, we ordered a CT abdomen. It did show gallstones, but nonobstructing. It showed kidney stones in the renal pelvis, but none obstructing. No other inflammation or signs of bleeding. Blood pressure came down after medicines in the ER. Did have some lower blood pressures through the afternoon evening which was felt to be a combination of blood pressure low in medicines in the ER and pain medication. From 11:00 p.m. onward blood pressures were controlled. Patient continued to have severe abdominal pain. Hemoglobin down to 9.0 from prior 12.4 yesterday. Creatinine up from 0.9 yesterday to 1.8. White count up from 8.3 yesterday to 14.4. INR from 4.3 yesterday to 4.2. Coumadin was held yesterday. CT abdomen was repeated. CT abdomen was read as worrisome for necrotic gallbladder and small bile leak Contacted transfer line at hospital. Surgery accepted and wanted transfer to go through the ER. Patient has PCN allergy. Surgery said that if reaction was not severe, they wanted Invanz given before she left. Patient says that she had a itching rash in the 70s. No trouble breathing or swallowing. No other reaction. Dose of Invanz ordered. IVF were increased. HPI from hospital: 74 y.o. female who presents with Chief Complaint Patient presents with? Abnormal Scan Patient presents via EMS as a medical transfer from hospital after having gallbladder necrosis seen on CT imaging. She was given IV Invanz there. General surgeon was contacted by that facility and he accepted the patient for transfer to this facility. Apparently, the patient began having abdominal pain yesterday. Timing of onset was gradual. Severity is rated as severe at maximum intensity. Quality is described as aching abdominal pain. Symptoms have been improved after IV pain medicine. Symptoms worsen with nothing, and improve with IV pain medicine. History was provided by patient, EMS, transfer paperwork and EMR, and I spoke with treating doctor in general surgery who accepted the patient for transfer.
74 2021-04-09 loss of consciousness Knocked out for on day and a half; Headache; chills; Exhausted; This spontaneous case was reported b... Read more
Knocked out for on day and a half; Headache; chills; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Knocked out for on day and a half) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoporosis. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Knocked out for on day and a half) (seriousness criterion medically significant), HEADACHE (Headache), CHILLS (chills) and FATIGUE (Exhausted). At the time of the report, LOSS OF CONSCIOUSNESS (Knocked out for on day and a half), HEADACHE (Headache), CHILLS (chills) and FATIGUE (Exhausted) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medication were reported The treatment for the events was not provided This case was linked to MOD-2021-067568 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
74 2021-04-09 blood clot Blood clot; Fatigue extreme; muscle soreness; loss of appetite; Unable to get out of bed for four da... Read more
Blood clot; Fatigue extreme; muscle soreness; loss of appetite; Unable to get out of bed for four days so then they took her to the ER; Lack of circulation on legs due to blood clot produced a wound to develop in her leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) and FATIGUE (Fatigue extreme) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criteria hospitalization and medically significant), FATIGUE (Fatigue extreme) (seriousness criterion hospitalization), MYALGIA (muscle soreness), DECREASED APPETITE (loss of appetite), MOBILITY DECREASED (Unable to get out of bed for four days so then they took her to the ER) and LIMB INJURY (Lack of circulation on legs due to blood clot produced a wound to develop in her leg). The patient was hospitalized on 22-Mar-2021 due to FATIGUE and THROMBOSIS. At the time of the report, THROMBOSIS (Blood clot), FATIGUE (Fatigue extreme), MYALGIA (muscle soreness), DECREASED APPETITE (loss of appetite), MOBILITY DECREASED (Unable to get out of bed for four days so then they took her to the ER) and LIMB INJURY (Lack of circulation on legs due to blood clot produced a wound to develop in her leg) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
74 2021-04-10 platelet count decreased platelets dropped to 3000; This spontaneous case was reported by a consumer and describes the occurr... Read more
platelets dropped to 3000; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (platelets dropped to 3000) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Cancer (Patient takes "cancer medication"). Concomitant products included OSIMERTINIB MESILATE (TAGRISSO) and APIXABAN (ELIQUIS) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (platelets dropped to 3000) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 15-Mar-2021 to 24-Mar-2021 due to PLATELET COUNT DECREASED. At the time of the report, PLATELET COUNT DECREASED (platelets dropped to 3000) outcome was unknown. Not Provided Treatment of this event was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
74 2021-04-11 heart rate increased, atrial fibrillation 26 hours after the second vaccine shot, my heart rate shot up to 165 beats per minute and did not de... Read more
26 hours after the second vaccine shot, my heart rate shot up to 165 beats per minute and did not decrease. After an hour I was admitted to the Emergency Room and where I spent five hours in the ER receiving intervenous medications to bring my heart back back to normal. They diagnosed my condition as "atrial fibrillation with Rapid Ventricular Response". I was admitted to the hospital and kept overnight before being discharged at 5:00 pm on 3/6/2021. Sunday morning 3/7/21 I was back in the Emergency Room at Hospital, again with a heart rate of 165 beats per minute, where I was again treated to Atrial fibrillation with rapid ventricular response and discharged 3 hours later. Again, on Tuesday afternoon, 3/9/2021 I was again back in the emergency room at Hospital with a heart rate of 165 beats per minute and again treated for atrial fibrillation. later that evening I was transported to where I was hospitailzed for 2 days before being discharged with additional medications to control the Atrial Fibillation. For the next week I continued to have minor bouts of higher than normal heart rate, but found the new medications were controlling the condition.
74 2021-04-11 palpitations pt says about 2 days later after the vax her heart was pounding so hard that she could not catch her... Read more
pt says about 2 days later after the vax her heart was pounding so hard that she could not catch her breath. She laid down for a while. Pt went to her PCP to get a EKG. EKG was normal. She noticed at her doctors appt she had developed a red rash on her back, torso, arms, legs, and palms of her hands. She was given RX for cetirizine. This medicine worked and symptoms were better within the next day. Pt was told all of her symptoms were due to having the covid vax.
74 2021-04-12 anaemia 2 days after vaccine #2, developed severe vertigo which lasted about 3 days and settled into a swimm... Read more
2 days after vaccine #2, developed severe vertigo which lasted about 3 days and settled into a swimmy headed dizziness, headache, brainfog, increase in tinnitus, fatigue, and memory difficulty. There has been modest steady improvement, but symptoms seem to have plateaued 6 weeks out from vaccine
74 2021-04-12 cerebrovascular accident Stroke after first dose of vaccine
74 2021-04-12 blood clot Blood clots then death
74 2021-04-13 ischemic chest pain, hypertension at one week, the heavy fatigue start on regular bases. On 2/8 we call 911 with high blood pressure 2... Read more
at one week, the heavy fatigue start on regular bases. On 2/8 we call 911 with high blood pressure 200/95, heart pain, disorientation, spent 2 nights at hospital. started: heavy hair loss and appetite loss. coordination and balance problems what reflected.
74 2021-04-13 cardiac arrest According to hospital records, patient presented to the ER in full cardiac arrest with ongoing CPR i... Read more
According to hospital records, patient presented to the ER in full cardiac arrest with ongoing CPR in progress.
74 2021-04-13 loss of consciousness The decedent was last seen alive at approximately 0130 when the decedent's next of kin (NOK) heard t... Read more
The decedent was last seen alive at approximately 0130 when the decedent's next of kin (NOK) heard the decedent walking around the residence. The decedent complained of arm soreness and indigestion; the decedent received a second COVID-19 vaccination (Moderna) on 04/12/2021. The decedent went to the living room to sleep on the couch due to the health and soreness complaints. At approximately 0750, NOK entered the living room and found the decedent unconscious and not breathing.
74 2021-04-15 loss of consciousness Passing out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS O... Read more
Passing out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Heart disease, unspecified. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passing out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passing out) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. However, patient's underlying heart disease and pacemaker insertion may have been contributory. This case was linked to MOD21-065383 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. However, patient's underlying heart disease and pacemaker insertion may have been contributory. MOD21-065383:Crosslinked
74 2021-04-16 chest pain Onset of abdominal pain starting in LLQ radiating to left side of chest at 4:05pm
74 2021-04-16 heart rate irregular rapid heart beat and irregular beat
74 2021-04-16 fainting Approx 12-18 hrs after 2nd dose of Moderna vaccine, had episodes of dizziness, syncope and sinus pau... Read more
Approx 12-18 hrs after 2nd dose of Moderna vaccine, had episodes of dizziness, syncope and sinus pause. Observed overnight in hospital with no recurrence and condition resolved by d/c. Pt is very healthy, cyclist capable of 30 mi qod rides with no issues.
74 2021-04-18 blood clot Blood Clot in the Left leg; Pain in the Left Leg; This spontaneous case was reported by a consumer (... Read more
Blood Clot in the Left leg; Pain in the Left Leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood Clot in the Left leg) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL and HCTZ for Blood pressure high. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 13-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Pain in the Left Leg). On 14-Apr-2021, the patient experienced THROMBOSIS (Blood Clot in the Left leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood Clot in the Left leg) and PAIN IN EXTREMITY (Pain in the Left Leg) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Ultrasound joint: ultrasound (abnormal) Blood Clot in the Left leg. Patient did not have a history of Blood Clots. She was Not taking any hormones (Estrogen, Progesterone)Treatment for event included Eliquis for blood clot. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. Based on the current available information and temporal association between the use of the product and the onset date of the reported event a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event a causal relationship cannot be excluded.
74 2021-04-19 low platelet count Patient presented with generalized weakness, malaise, shivering, chills, being off balance, worsenin... Read more
Patient presented with generalized weakness, malaise, shivering, chills, being off balance, worsening memory issues and subjective fevers. Upon admission found to have hyponatremia. Also found to have thrombocytopenia, leukopenia and diagnosed with Hemophagocytic lymphohistiocytosis (HLH), hypofibrinogenemia secondary to HLH. Patient remains hospitalized and has been started on etoposide & dexamethasone per HLH-94 protocol.
74 2021-04-20 loss of consciousness A minute "gray out"and could not see; Nausea; This spontaneous case was reported by a consumer and d... Read more
A minute "gray out"and could not see; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (A minute "gray out"and could not see) in a 74-year-old female patient who received mRNA-1273 (batch nos. 046A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, LOSARTAN for Hypertension. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021 at 12:00 PM, the patient experienced LOSS OF CONSCIOUSNESS (A minute "gray out"and could not see) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (A minute "gray out"and could not see) and NAUSEA (Nausea) was resolving. Not Provided Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
74 2021-04-20 pulmonary embolism Breathing problems starting Feb 25th, approx 2PM, escalating until Mar 1st when patient went to Walk... Read more
Breathing problems starting Feb 25th, approx 2PM, escalating until Mar 1st when patient went to Walk-In Clinic for immediate care. Her oxygen saturation level was found to be in the upper 80's percentage. Was then taken by ambulance to Hospital and given oxygen. At hospital she was given a blood thinner drip. Also performed CT scan and found blood clots in her lungs. She was released to return home approx 24 hrs later with blood thinner pills (Eliquis) and at-home oxygen generation. These were necessary for approx two weeks until her O2 levels returned to normal without supplemental O2.
74 2021-04-21 pulmonary embolism Patient had bilateral pulmonary emboli and microcytic anemia
74 2021-04-22 atrial fibrillation Atrial fibrillation for 4 days; condition aggravated; Couldn't stand up straight or walk in a straig... Read more
Atrial fibrillation for 4 days; condition aggravated; Couldn't stand up straight or walk in a straight line during the atrial fibrillation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation for 4 days) and CONDITION AGGRAVATED (condition aggravated) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included WARFARIN, ATENOLOL and ATORVASTATIN for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation for 4 days) (seriousness criterion medically significant), CONDITION AGGRAVATED (condition aggravated) (seriousness criterion medically significant) and GAIT DISTURBANCE (Couldn't stand up straight or walk in a straight line during the atrial fibrillation). On 16-Apr-2021, GAIT DISTURBANCE (Couldn't stand up straight or walk in a straight line during the atrial fibrillation) outcome was unknown. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation for 4 days) and CONDITION AGGRAVATED (condition aggravated) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was treated with Cartia (diltiazem) as advised by their health care professional to try to alleviate the symptoms. Action taken with mRNA-1273 in response to events was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. cross linked case
74 2021-04-22 fainting chills, diaphoresis, syncope
74 2021-04-24 cerebral haemorrhage, heart rate irregular 3/20/21: Pt bib Medical Center via helicopter with c/o headache/ seizure. Per FR, pt was driving whe... Read more
3/20/21: Pt bib Medical Center via helicopter with c/o headache/ seizure. Per FR, pt was driving when she was witnessed by friend having a possible seizure. Upon arrival to ED, pt had second episode of possible seizure. Pt given Ativan, Keppra and thiamine in ED. Pt is AAOx4 upon arrival, speech mildly delayed. VSS at this time. Pt reports drinking a bottle of liquor everyday and states a PMH of alcohol withdraw. Progress note from 3/25/21: Neurological examination at this time continues stable. Patient underwent DSA yesterday with findings of left frontal lobe cortical vein thrombosis with hemorrhagic conversion. Documented that given timing of events, a consideration should be given to possible COVID vaccine related thrombosis and may advise against second dose of vaccine. EEG with no evidence of epileptiform discharges. Continues with intermittent word finding difficulties/confusion, but continues following all commands consistently. Possible that some component is also related to longstanding ETOH abuse? Pending discussion of findings with NES, apparently patient was reported to have episodes of irregular heartbeat during DSA?
74 2021-04-25 blood pressure increased weakness in BLE, shallow breathing, elevated B/P (systolic ranging from 213 to 163), this morning B/... Read more
weakness in BLE, shallow breathing, elevated B/P (systolic ranging from 213 to 163), this morning B/P 179/89 Went to ER, script from hospital were just painkillers per husband. Recommended to continue taking b/p medications, and to obtain a pulse oximeter, and oxygen tank depending on blood oxygen reading. If symptoms worsen, contact primary provider. 4/19-Completed follow up call on 4/19/2021 at 10:27am: Pt reports that she feels a little weak (she contribute this to her laying down too much), and feeling lightheaded when she stands up to quickly. Otherwise, pt reports she is feeling much better today (BP 149/71, pulse: 79, blood sugar: 78). Pt states she went to the ER as a percauation, tests were done and she was released the same day she went in. Pt reports she is to follow up with her MD, and no prescriptions was written from ER. Pt also reported that with both of her shots she had some tenderness in her right arm ~1 hour afterwards, the tenderness went away the next day. Recommend pt to regularly monitor her BP and blood sugar at home, keep a log and bring to her follow up visits with MD. Also recommend pt to make sure to get up slowly from sitting or laying down position, and to hold onto something while standing for approx. 30 sec to a minute to make sure stance is steady enough walk to prevent fall risks since she states she gets lightheaded.
74 2021-04-25 haemoglobin decreased The first shot was on 02/06/2021 , the second on 03/06/2021. After the first shot, I noticed that th... Read more
The first shot was on 02/06/2021 , the second on 03/06/2021. After the first shot, I noticed that the HGB and Retic ct abs both decreased. Around Mar 20th, I suspected my HGB was decreasing. On March 25th, I requested a CBCD blood test.The HGB was now only 10.2. For over the past year, my HGB had varied from 11.5 to 12.7. Then the HGB continued to decrease to 6.9 on April 22 when a blood transfusion was ordered for the next day. A bone marrow biopsy was conducted April 14, (6 weeks after the 2nd shot) and showed CLL cells taking over the sample (see page 2 sticky note). Prior to the vaccination, the blood tests were stable. It seems the vaccination excited the CLL so now significant cancer treatment is needed.
74 2021-04-25 pulmonary embolism approx. 2 weeks after her dose #2 of Moderna and approx 5 to 6 weeks after a hip replacement, pt had... Read more
approx. 2 weeks after her dose #2 of Moderna and approx 5 to 6 weeks after a hip replacement, pt had shortness of breath and back pain that evidentially ruled in for Pulmonary Embolism
74 2021-04-25 pulmonary embolism On 4/4/21 pt got 101 temp. Next day her temp was down but she was having problems breathing. She h... Read more
On 4/4/21 pt got 101 temp. Next day her temp was down but she was having problems breathing. She had to get cans of O2 to help her breathe. Her O2 was going from the 80's to 60's. She went to her pulmonologist on 4/22/21 pulmonologist and he sent to Hospital. She was put on O2 and other medicines. They did CT, X-rays, and blood work. They found a blood clot in her lung so was admitted for treatment. She will be there for a minimal for three more days till they can get her an O2 tank to send her home.
74 2021-04-25 blood clot Patient called and reported she had a blood clot in her leg confirmed by doctor on 4/14/21. Leg pain... Read more
Patient called and reported she had a blood clot in her leg confirmed by doctor on 4/14/21. Leg pain started 4/13/21. Patient reported her doctor informed her the clot was due to the COVID vaccine she received. Doctor put her on Elliquis and instructed her to elevate leg. She follows up with doctor once a week.
74 2021-04-26 cerebrovascular accident experiencing a stroke in both eyes that affected her whole left side of the bodyand moved to the rig... Read more
experiencing a stroke in both eyes that affected her whole left side of the bodyand moved to the right side; lost of sight after taking moderna vaccine; huge lump on arms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (experiencing a stroke in both eyes that affected her whole left side of the bodyand moved to the right side), BLINDNESS (lost of sight after taking moderna vaccine) and LIMB MASS (huge lump on arms) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (experiencing a stroke in both eyes that affected her whole left side of the bodyand moved to the right side) (seriousness criterion hospitalization), BLINDNESS (lost of sight after taking moderna vaccine) (seriousness criterion hospitalization) and LIMB MASS (huge lump on arms) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to BLINDNESS, CEREBROVASCULAR ACCIDENT and LIMB MASS. At the time of the report, CEREBROVASCULAR ACCIDENT (experiencing a stroke in both eyes that affected her whole left side of the bodyand moved to the right side), BLINDNESS (lost of sight after taking moderna vaccine) and LIMB MASS (huge lump on arms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments No concomitant medications were reported. No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provided at this time. Further information has been requested.
74 2021-04-26 heart rate increased elevated heart rate tired no appetite fever tremors headache rash on stomach
74 2021-04-27 blood pressure fluctuation Injection area muscle soreness, first sign, continued down my arm over 24 hrs, extreme burning weakn... Read more
Injection area muscle soreness, first sign, continued down my arm over 24 hrs, extreme burning weakness entire arm, neck pain, unable to move arm and terrible pain. Tylenol did not help. Went to ER prescribed norco lightest dosage, advised to cut in half, rest, sleep. Went to my doctor two days later, still some pain, not nearly as bad, given naproxen and stopped norco My doctor said to report to VAERS adverse REACTION
74 2021-04-27 ejection fraction decreased The patient got the second Moderna COVID vaccine on 4/9/2021. Then 1 week later on 4/16/2021, she d... Read more
The patient got the second Moderna COVID vaccine on 4/9/2021. Then 1 week later on 4/16/2021, she developed pain in left calf that got progressively worse. Then came to ER on 4/18/2021 and was diagnosed with thrombosis/occlusion in left popliteal artery. She was admitted and put on IV heparin. This was thrombolyzed by interventional radiology on 4/19/2021. She was discharged on 4/23/2021. She has had resolution of pain in the left leg. She has never had this before. She does have some apical hypokinesis on echocardiogram but that is not really new. EF 45%. Now is on warfarin.
74 2021-04-28 cardiac arrest Confusion 6 days after shot. Within a week lost ability to walk, became urinary incontinent. Major c... Read more
Confusion 6 days after shot. Within a week lost ability to walk, became urinary incontinent. Major chest congestion, slept all the time. Rushed by ambulance at day 12.. Diagnosed with pneumonia amd uti. Cardiac arrest at day 14, never woke up. Taken off life support 3/20/21.
74 2021-04-28 palpitations, atrial fibrillation, heart rate increased Moderna COVID-19 Vaccine EUA: I developed sudden onset atrial fibrillation 11 days after injection n... Read more
Moderna COVID-19 Vaccine EUA: I developed sudden onset atrial fibrillation 11 days after injection number 1. (shortness of breath, rapid heart rate, palpitations)
74 2021-04-29 chest discomfort, chest pain Tightness in chest about 5 hours after the shot. Over the following few days the condition escalate... Read more
Tightness in chest about 5 hours after the shot. Over the following few days the condition escalated to breathlessness and moderate intermittent chest pain (I have no previous history of respiratory issues. I couldn't run or walk up stairs or a slight grade without getting out of breath. I sought medical attention on 4/27/2021. The Dr. heard wheezing and chest sounds for which he prescribed Flovet. I have never taken an inhaler before this time. Concurrent with the shortness of breath, I had a urinary infection. I have not had one in at least 30 years. I was prescribed Sulfamethoxazole, and took two rounds. I had a second positiveurinalysis, and prescribed Ciprofloxacin HCLon 04/29/2021.
74 2021-05-01 chest pain Sudden extreme fatigue about 12 hours after shot and ongoing to present. Slept for 12 hours overnig... Read more
Sudden extreme fatigue about 12 hours after shot and ongoing to present. Slept for 12 hours overnight and 1 hour in morning and 2 hours in afternoon, but still feeling extreme fatigue. Ongoing severe abdominal pain, severe muscle-aches and pain. Nausea, complete loss of appetite. Twice I felt a sharp muscle pain (like a "stitch") in upper right side of chest (in front). Injection site very sore.
74 2021-05-02 hypertension Diagnosed with Shingles - left side of my face and head. I had chicken pox as a kid and got my vacci... Read more
Diagnosed with Shingles - left side of my face and head. I had chicken pox as a kid and got my vaccine around 10 yrs ago
74 2021-05-05 cardiac arrest Patient suffered cardiac arrest today
74 2021-05-06 atrial fibrillation, arrhythmia Patient presented to the ED on 4/6/21 with Atrial fibrillation with RVR. Patient presented to the ED... Read more
Patient presented to the ED on 4/6/21 with Atrial fibrillation with RVR. Patient presented to the ED on 4/11/21 and was subsequently admitted with Atrial flutter with rapid ventricular response.
74 2021-05-07 cerebrovascular accident This 74 year old female received the Moderna Covid shot on 2/26/21 and went to the ED on 4/18/... Read more
This 74 year old female received the Moderna Covid shot on 2/26/21 and went to the ED on 4/18/21 and was admitted on 4/18/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) I63.9 - Stroke determined by clinical assessment R29.810 - Facial weakness
74 2021-05-07 nosebleed Pt reported extended nose bleed for 5 days following the vaccine. Enough to soak piles of tissues an... Read more
Pt reported extended nose bleed for 5 days following the vaccine. Enough to soak piles of tissues and was constant.
74 2021-05-09 chest pain Very Sharp pain upper back thoracic area and upper arms like stabbing. Very sharp and excruciating ... Read more
Very Sharp pain upper back thoracic area and upper arms like stabbing. Very sharp and excruciating pain lower part areas around both ears. It starts everyday around 8:30pm . I have to sit or lay down and last about 30 minutes. After that the pain goes down very slightly step by step. Before it starts, I have a big sweat on my head. I feel exhausted. It has been 12 days non stop now and I can not stand it anymore.
74 2021-05-09 lightheadedness Received 2nd COVID Vaccine and the following day had vision changes, vertigo and near syncope.
74 2021-05-09 fainting syncope, body aches, nausea
74 2021-05-10 blood pressure increased Vaccine 2/26/21, then 2/27/21 pt developed Headache, loss of vision left eye, elevated BP. Left lid ... Read more
Vaccine 2/26/21, then 2/27/21 pt developed Headache, loss of vision left eye, elevated BP. Left lid ptosis with cranial nerve 3,4,and 6 Palsey . Treated with Toradol at Emergency dept on 3/4/21. Metocloprimide, diphenhydromine, dexemethasone, tetracaine. CT head performed, CMP, PT/INR and IV fluids. In the doctors office visit on 3/3/21, treatment Dexemethatsone, Toradol. Brain MRI, STAT neuro referral.
74 2021-05-10 low platelet count J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified D69.6 - Thrombocyt... Read more
J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified D69.6 - Thrombocytopenia, unspecified
74 2021-05-11 chest discomfort soreness at first. One hour after dizzy, lightheaded. few hours later stuffy chest tight, wheezing... Read more
soreness at first. One hour after dizzy, lightheaded. few hours later stuffy chest tight, wheezing, fever,, fatigue, chills. 2 weeks later red welt 3 1/2 in by 6 in on site of vaccine and itchy. lasted 1 1/2 weeks. Low grade fever for 3 weeks fatigue continues
74 2021-05-11 loss of consciousness lost consciousness and blacked out; In the process of her fall, she also hurt her back; felt foggy/i... Read more
lost consciousness and blacked out; In the process of her fall, she also hurt her back; felt foggy/it was as if a round black thing was coming at me in my brain/My feet and legs melted; bit confused; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness and blacked out) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE for an unknown indication. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced BACK INJURY (In the process of her fall, she also hurt her back), FEELING ABNORMAL (felt foggy/it was as if a round black thing was coming at me in my brain/My feet and legs melted) and CONFUSIONAL STATE (bit confused). On 23-Mar-2021 at 5:00 PM, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness and blacked out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (lost consciousness and blacked out), BACK INJURY (In the process of her fall, she also hurt her back), FEELING ABNORMAL (felt foggy/it was as if a round black thing was coming at me in my brain/My feet and legs melted) and CONFUSIONAL STATE (bit confused) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: covid19 (Positive) diagnosis of COVID19. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient took Ibuprofen to relieve the pain after the fall. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
74 2021-05-12 cerebrovascular accident Patient woke up with right upper and lower extremity weakness on 4/27/2021. She did not go to the ER... Read more
Patient woke up with right upper and lower extremity weakness on 4/27/2021. She did not go to the ER. I suspect stroke and have ordered CT brain.
74 2021-05-12 cerebrovascular accident Left Hemispheric Stroke with Right Hemiplegia and loss of speech. 5 days after 2nd dose of Moderna... Read more
Left Hemispheric Stroke with Right Hemiplegia and loss of speech. 5 days after 2nd dose of Moderna.
74 2021-05-17 fainting She got the vaccine, had no issues other than regular symptoms. The following day had a temp of 100... Read more
She got the vaccine, had no issues other than regular symptoms. The following day had a temp of 100, tired, and was achy and fine by that Monday. On 3/9/21 she developed goose bumps all over her body, even her face, and then had freezing chills that lasted every day around 5:00 PM and lasted for hours for weeks and weeks. To this date she is still getting a weird sensation like a shiver and goosebumps multiple times a day, every day. She has had a woozy feeling, not real stable feeling at times. She has seen her PCP, and also has had multiple telehealth appointments including an infectious disease provider who said he reported it to the CDC. Because of the fainting the night before the vaccine, she had to have an echocardiogram that was normal, an MRI of the brain/neck to make sure she did not have an injury when she fell and is scheduled for an EEG tomorrow. If everything continues to be normal then the reactions are related to the vaccine.
74 2021-05-18 oxygen saturation decreased Difficulty breathing and low blood oxygen saturation without the use of oxygen
74 2021-05-22 pulmonary embolism bilateral pulmonary emboli with right heart strain diagnosed on 5/23/21. Patient with no other know... Read more
bilateral pulmonary emboli with right heart strain diagnosed on 5/23/21. Patient with no other known risk factors for PTE. Symptom onset ~5/19/21
74 2021-05-22 blood clot Developed swelling (edema) in both legs and groin. It continues to worsen. We have checked for blo... Read more
Developed swelling (edema) in both legs and groin. It continues to worsen. We have checked for blood clots, Heart problems, tumors, and vascular problems, and urine and blood tests. All have come up negative for a cause of the swelling.
74 2021-05-23 chest pain chest pain and shortness of breath, constant dull pain
74 2021-05-23 low blood oxigenation Patient given first dose of vaccine on 3/25 and was hospitalized on 4/14 with SOB and acute hypoxia,... Read more
Patient given first dose of vaccine on 3/25 and was hospitalized on 4/14 with SOB and acute hypoxia, with interstitial lung disease. She underwent bronchoscopy and thought it was related to amiodarone toxicity, despite only 1 month exposure. Her amiodarone was discontinued and she was sent on steroid taper with improvement. She received 2nd dose of Moderna vaccine on 5/12. Became symptomatic again on 5/19 with SOB and hypoxia again. Currently being admitted. Concerning for vaccine induced Interstitial lung disease
74 2021-05-24 hypertension After receiving the COVID vaccine patient felt flushed/hot. Upon taking her BP we found it to be ext... Read more
After receiving the COVID vaccine patient felt flushed/hot. Upon taking her BP we found it to be extremt.ely high 240/140.. PA did a quick chart review and intake, finding the patient had not been taking blood pressure medication and had not been to her PCP since 2019.
74 2021-05-24 palpitations Tenderness at injection site, ear aches & ringing in both ears like (nat'l alert) severe headaches o... Read more
Tenderness at injection site, ear aches & ringing in both ears like (nat'l alert) severe headaches on top of head with chills. Aches and pain on left side of face , neck and down the left side of my body. Joint pains, Nausea and heart palpitations. Dizziness and deep sleepiness.
74 2021-05-25 pulmonary embolism, blood clot Great difficulty breathing, diagnosed with pulmonary embolism and one clot in right leg on May 15. ... Read more
Great difficulty breathing, diagnosed with pulmonary embolism and one clot in right leg on May 15. First went to hospital with extreme breathing difficulty on March 15 but no diagnosis was made. this was one month after first Moderna vaccination. Two months later, with same issues (also extremely swollen ankles) and same tests, the embolisms were seen on CT test with contrast.
74 2021-05-26 cardiac arrest Difficulty breathing, coughing, congestion, dies of cardiac arrest.
74 2021-05-30 chest pain chest pain, fatigue, death
74 2021-05-31 chest pain lost weight; lack appetite; Patient is taken to the hospital with chest pain, it like a knife going ... Read more
lost weight; lack appetite; Patient is taken to the hospital with chest pain, it like a knife going in chest; arm pain; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest), WEIGHT DECREASED (lost weight) and DECREASED APPETITE (lack appetite) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest) (seriousness criterion hospitalization). On an unknown date, the patient experienced WEIGHT DECREASED (lost weight) (seriousness criterion hospitalization), DECREASED APPETITE (lack appetite) (seriousness criterion hospitalization), PAIN IN EXTREMITY (arm pain) and CHILLS (Chills). The patient was hospitalized on 09-May-2021 due to CHEST PAIN, DECREASED APPETITE and WEIGHT DECREASED. The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) ongoing since an unknown date at a dose of UNK dosage form and CALCIUM CARBONATE (MYLANTA [CALCIUM CARBONATE]) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest), WEIGHT DECREASED (lost weight), DECREASED APPETITE (lack appetite), PAIN IN EXTREMITY (arm pain) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Electrocardiogram: normal (normal) arteries are clean and blood pressure is ok. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
74 2021-05-31 palpitations, heart rate irregular The main thing that I remember is that I experienced an irregular heartbeat. It was racing faster th... Read more
The main thing that I remember is that I experienced an irregular heartbeat. It was racing faster than usual. It could have been into A-Fib, but it was so different from A-Fib and that's why I was concerned. It lasted for 8-10 hours. I called my Cardiologist and he saw me on 02/06/2021. By the time I had my appointment, everything was back to normal. Well, as normal as can be with A-Fib.
74 2021-06-01 loss of consciousness Patient received 2nd dose of Moderna vaccination in her right deltoid on 3/10/2021 at 1242. On 3/11/... Read more
Patient received 2nd dose of Moderna vaccination in her right deltoid on 3/10/2021 at 1242. On 3/11/2021, patient passed out and landed on face. Patient was taken to hospital in ambulance and received stitches from fall and claimed to have nausea and vomiting. Patient still feels numbness on face.
74 2021-06-01 heart attack Patient's daughter came to the pharmacy today and said patient died of a heart attack. Patient thou... Read more
Patient's daughter came to the pharmacy today and said patient died of a heart attack. Patient thought that she was sick from the vaccine. Did not get help until five days after
74 2021-06-01 palpitations Sore arm one day post vaccination, no other symptoms until event on May 28 which involved racing hea... Read more
Sore arm one day post vaccination, no other symptoms until event on May 28 which involved racing heart, shortness of breath. Hospitalized in ER overnight. Release 8 hours after arrival. Upon return home, shortness of breath, wheezing, retention of fluids (leg and foot edema), low-grade fever
74 2021-06-02 cerebrovascular accident Stroke; Lost sight in one eye; Double vision; This spontaneous case was reported by a consumer (subs... Read more
Stroke; Lost sight in one eye; Double vision; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and BLINDNESS UNILATERAL (Lost sight in one eye) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced BLINDNESS UNILATERAL (Lost sight in one eye) (seriousness criterion medically significant) and DIPLOPIA (Double vision). On 16-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 16-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), BLINDNESS UNILATERAL (Lost sight in one eye) and DIPLOPIA (Double vision) outcome was unknown. Concomitant product use was not provided. It was reported that the patient is planning to go to rehab center from Hospital. Treatment information was unknown. Very limited information regarding these events has been provided at this time. Further information has been requested; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested
74 2021-06-02 palpitations, heart rate irregular End of February , I began to have racing heart rate and palpitations and after a week went to prima... Read more
End of February , I began to have racing heart rate and palpitations and after a week went to primary. she prescribed Xanax . I didn't take the meds and within 10 days I went to cardiologist. I was put on heart monitor for a week.. results were some irregular heartbeats. I was put on beta blockers and after three days had to discontinue due to exhaustion. I have a follow up appt at cardiologist on June 15, 2021.
74 2021-06-02 pulmonary embolism, heart attack, ejection fraction decreased myocardial infarction, pulmonary embolisms
74 2021-06-02 fainting Faint; Weak; Chills; Feverish; This spontaneous case was reported by a consumer and describes the oc... Read more
Faint; Weak; Chills; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0402B1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2020. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced CHILLS (Chills) and PYREXIA (Feverish). On 27-Apr-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant) and ASTHENIA (Weak). At the time of the report, SYNCOPE (Faint), ASTHENIA (Weak), CHILLS (Chills) and PYREXIA (Feverish) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 antibody test: positive (Positive) Positive. In March 2021, SARS-CoV-2 antibody test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications taken by the patient included thyroid medications and cholesterol medications. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
74 2021-06-05 heart attack NSTEMI, symptoms started around administration of vaccine. symptoms got worse which made her come to... Read more
NSTEMI, symptoms started around administration of vaccine. symptoms got worse which made her come to hospital treatment: went to cardiac cath, received 2 stents outcome: discharged to home
74 2021-06-07 palpitations 3/18 - severe heart palpatations started; episodes continued for several days
74 2021-06-08 pulmonary embolism, fibrin d dimer increased, chest discomfort Patient is a very pleasant 75-year-old female with a past medical history significant for COPD chron... Read more
Patient is a very pleasant 75-year-old female with a past medical history significant for COPD chronically on 2 L of oxygen, hypertension, type 2 diabetes which is diet controlled and oral Metformin controlled, hyperlipidemia, GERD, anemia, past history of PE and DVT diagnosed in January 2021 following COVID-19 infection currently on Eliquis compliant twice daily and kidney stone history who presented with worsening exertional chest tightness and shortness of breath as well as nausea for the past 2 weeks. Patient reported she got to the point that she was hardly able to walk due to her exertional shortness of breath and chest tightness and needed to be evaluated. She also reported some nausea as well as some headaches that have come on around a similar timeframe. She also reported some poor dentition and mild dental pain and has been having a difficult time getting into a dentist due to her Medicaid and lack of coverage. She has a history of hospitalization from January 30 to February 25 for sepsis secondary to healthcare associated pneumonia and UTI and at that time was treated with vancomycin, azithromycin and cefepime during that hospitalization she was noted to have a new onset left peroneal vein DVT and peripheral PE which was thought secondary to possibly her past history of Covid infection from December 28, 2020. She was placed on Eliquis twice a day. During her lengthy hospital from January 30 to February 25 she had bacteremia with Enterococcus and echocardiogram showed a possible pacemaker lead vegetation and therefore her pacemaker was removed on February 12 and she was discharged to rehab for 6 weeks of ampicillin and ceftriaxone which was completed on March 23, 2021. She was then ultimately discharged home. She had follow-up with cardiology who felt that she no longer needed to have a pacemaker and it was therefore left out. She reports she was doing well up until about 2 weeks ago when she began to have the shortness of breath. She received her COVID-19 vaccines on 3/18 and 4/16. She reported after the 2nd one on4/16 she was ill with significant fatigue and fever and malaise. She reports she completely recovered from that but again began having shortness of breath and exertional chest pain 2 weeks ago which prompted her current admission. She was subsequently admitted to the hospital and ultimately underwent a CTA of the chest when her D-dimer was noted to be elevated at 1800. CTA of the chest revealed a new left lower lobe pulmonary artery emboli with right heart strain. She subsequently underwent an echocardiogram which did not reveal any evidence of acute heart strain. She had a CT venogram of the head and subsequent MRI of the brain which revealed no cavernous vein thrombosis and no acute abnormality other than possible mastoiditis which may be chronic. The case was reviewed with hematology and her Eliquis was discontinued and she was placed on Lovenox injections twice daily. She was educated on administering these injections herself. She will be following up with hematology as an outpatient for close monitoring. She was also placed on an antibiotic for her dental caries and the mastoiditis as she did complain of the nausea and persistent headache and we arranged dental follow up on dc. At this time she is felt stable for discharge to home. She remains with some shortness of breath above her usual baseline but feels that it is getting better each day. Her O2 sat is 95% on her usual 2 L of oxygen. Reason for report:new PE of the left lower lobe -radiologist who reviewed past cta chest from jan and reports that that old small pe is gone and this is a new much larger PE in a different location Sx's started and worsening the last few weeks pta She has been compliant with her eliquiss twice a day Venous dopplers neg and previous dvt of the L peroneal vein seen 1/30/21 and re imaged on 2/21/21 was also noted to be gone Pt had her 2nd covid 19 vaccine just last month 4/16/21 Current echo shows no R heart strain and nl ef started on lovenox bid per hematology beta 2 glycoprotein IgG and IgM, antiphospholipid ab's are negative
74 2021-06-13 heart attack, atrial fibrillation -progression to Atrial fibrillation and NSTEMI. As well as acute on chronic CHF -monitored and disch... Read more
-progression to Atrial fibrillation and NSTEMI. As well as acute on chronic CHF -monitored and discharged on Eliquis and increase in metoprolol tartrate 50 mg BID and increase in furosemide 40 mg daily
74 2021-06-13 chest pain, heart attack -she was having chest pain with radiating arm pain; NSTEMI -went to cardiac cath and received drug e... Read more
-she was having chest pain with radiating arm pain; NSTEMI -went to cardiac cath and received drug eluting stent. treated with Brilinta 90 mg BID, atorvastatin 80 mg, aspirin 81 mg, and increased her carvedilol to 50 mg BID -discharged home.
74 2021-06-14 blood glucose increased prolonged exhaustion, myalgias and elevated blood sugars that lasted 2 months
74 2021-06-14 cerebrovascular accident Right hemispheric stroke
74 2021-06-14 platelet count decreased, hypotension, pulmonary embolism, fainting, haemoglobin decreased, blood glucose increased Patient presented to the ED in the early morning of 5/27/21 complaining of nausea/vomiting/diarrhea ... Read more
Patient presented to the ED in the early morning of 5/27/21 complaining of nausea/vomiting/diarrhea since she received her second dose of COVID vaccine on 5/5. Patient states that prior to coming to the ED she had a syncopal episode preceded by nausea, diaphoresis, paresthesias, tinnitus and lightheadedness. She stated that she had started to experience shortness of breath the intermittently a week before she was seen in the ED. Patient was found to have a massive saddle PE with extensive bilateral pulmonary embolism. Patient's BP in ED was low at 94/52 and her HR was 130. Patient was given fluid boluses, started on anticoagulants and admitted to the critical care unit. Later on 5/27, patient underwent a mechanical thrombectomy which was successful. Patient was then transitioned to apixaban and discharged. (Patient had previously been seen in the ED on 5/8/21 for complaints of nausea, vomiting and diarrhea since receiving her COVID vaccine on 5/5. Patient was given IV fluids and ondansetron and felt better. She was prescribed ondansetron on discharge from the ED.)
74 2021-06-15 heart rate irregular, loss of consciousness I had severe chills through the night. Felt lke i had the flu the next morning. I couldn't eat but t... Read more
I had severe chills through the night. Felt lke i had the flu the next morning. I couldn't eat but tried and threw up over myself and passed out. My temp went up to 103 that day and i took tylenol. For the next week i barely ate. I woke up on a Friday morning and my heart was beating funny. I checked my blood pressure and it showed I had an irregular heart beat. I went to the hospital they gave me an IV that brought my heart arrythmia back to normal.The cardilogist told me to come back in a week to get a heart murmur on to watch my heart beat.
74 2021-06-15 troponin increased The patient is a 74-year-old female who presented to hospital with COVID-19 and exhibited shortness ... Read more
The patient is a 74-year-old female who presented to hospital with COVID-19 and exhibited shortness of breath. The patient has acute respiratory failure also and was treated with IV steroids. The patient improved throughout stay. She did have elevated troponins and was started on heparin drip, but this was deemed to be demand ischemia.
74 2021-06-16 hypertension 3 weeks after 2nd vaccine, everything I had before became huge/worse, my anxiety, exhaustion, unable... Read more
3 weeks after 2nd vaccine, everything I had before became huge/worse, my anxiety, exhaustion, unable to focus. I also had vertigo. I was extremely anxious, spacey, dizzy and with vertigo. I also had horrible migraines. The anxiety, spacey-ness, and migraines have slowly dissipated, almost completely gone as of now. The dizziness is better but it is still there. My blood pressure also got insanely high, so I was put on high blood pressure medication. My blood pressure has gotten better over time.
74 2021-06-17 chest pain Caller said she experienced headaches that are out of the the ordinary. Random sharp shooting pains ... Read more
Caller said she experienced headaches that are out of the the ordinary. Random sharp shooting pains all over her head and brain. Caller started feeling the same pain in her heart.
74 2021-06-18 palpitations Mild heart palpitations.... maybe for 10 or 15 minutes, a few times a day.
74 2021-06-20 heart attack Acute respiratory failure requiring intubation; Non-ST segment elevation MI
74 2021-06-23 chest pain, chest discomfort admitted to hospital; 74-year-old female with a past history of hypertension has been feeling exhaus... Read more
admitted to hospital; 74-year-old female with a past history of hypertension has been feeling exhausted feeling tired recently as a pressure in the chest and some chest pain. She is presented to the ER and was found to have complete heart block placed on a monitor rate is in the 30s; patient found to be also coronavirus positive. Patient placed in isolation
74 2021-06-24 hypertension, atrial fibrillation Death: 5/3/2021 Causes of death listed on death certificate: -1) Acute hypoxic respiratory failure... Read more
Death: 5/3/2021 Causes of death listed on death certificate: -1) Acute hypoxic respiratory failure 2) Acute on chronic diastolic heart failure 3) Atrial fibrillation 4) Covid 19 pneumonia Other: Hypertension. Acute toxic encephalopathy. Type 2 diabetes. Esophageal dysphagia. Debility. Depression. Moderate malnutrition.
74 2021-06-27 heart attack Heart attack
74 2021-06-28 heart attack AKI (acute kidney injury) NSTEMI (non-ST elevated myocardial infarction)
74 2021-06-28 chest pain chirocryptogenic organizing pneumonia/CT scan saw spots in my lungs; little purple spots; which look... Read more
chirocryptogenic organizing pneumonia/CT scan saw spots in my lungs; little purple spots; which looked like a blood blister; Hands were swollen; Hand was so puffy; Bottom lip was very swollen; Started having chest pain; Half part of top lip is still swollen; Full of cold sores; Started getting hives on my chest,arms,stomach,bra line; Very itchy all over in the evening/she has been itchy off and on. This itchiness moves from her head, to the back of her legs, then to her chest regularly; Rash; This spontaneous case was reported by a consumer and describes the occurrence of ORGANISING PNEUMONIA (chirocryptogenic organizing pneumonia/CT scan saw spots in my lungs) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ATORVASTATIN, BUPROPION, VITAMIN D NOS, DOCUSATE SODIUM (COLACE), FISH OIL, LEVOTHYROXINE, METOPROLOL, OMEPRAZOLE, TRAZODONE, ACETYLSALICYLIC ACID, VACCINIUM MACROCARPON (CRANBERRY NS) and DOCUSATE SODIUM for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (Very itchy all over in the evening/she has been itchy off and on. This itchiness moves from her head, to the back of her legs, then to her chest regularly) and RASH (Rash). On 04-Mar-2021, the patient experienced PERIPHERAL SWELLING (Hands were swollen), SKIN SWELLING (Hand was so puffy), LIP SWELLING (Bottom lip was very swollen), CHEST PAIN (Started having chest pain), LIP SWELLING (Half part of top lip is still swollen), ORAL HERPES (Full of cold sores) and URTICARIA (Started getting hives on my chest,arms,stomach,bra line). On an unknown date, the patient experienced ORGANISING PNEUMONIA (chirocryptogenic organizing pneumonia/CT scan saw spots in my lungs) (seriousness criterion medically significant), SKIN DISCOLOURATION (little purple spots) and BLISTER (which looked like a blood blister). At the time of the report, ORGANISING PNEUMONIA (chirocryptogenic organizing pneumonia/CT scan saw spots in my lungs), PERIPHERAL SWELLING (Hands were swollen), SKIN SWELLING (Hand was so puffy), LIP SWELLING (Bottom lip was very swollen), CHEST PAIN (Started having chest pain), ORAL HERPES (Full of cold sores), URTICARIA (Started getting hives on my chest,arms,stomach,bra line), SKIN DISCOLOURATION (little purple spots), BLISTER (which looked like a blood blister) and RASH (Rash) outcome was unknown and LIP SWELLING (Half part of top lip is still swollen) and PRURITUS (Very itchy all over in the evening/she has been itchy off and on. This itchiness moves from her head, to the back of her legs, then to her chest regularly) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Cardiac stress test: normal (normal) Normal. On 04-Mar-2021, Computerised tomogram: spot in lungs (abnormal) Spot in lungs. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Coenzyme Q 10 and multivitamins used as a concomitant medication. No treatment medication information was mentioned Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Significant Follow-up appended; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
74 2021-06-29 heart failure Death 5/30/2021 Causes of death listed on death certificate: 1) Covid 19 Pneumonia 2) colo-vesica... Read more
Death 5/30/2021 Causes of death listed on death certificate: 1) Covid 19 Pneumonia 2) colo-vesical fistular 3) Heart failure 4) chronic uti
74 2021-06-30 low blood oxigenation Presented to ED with 2 weeks of SOB, not feeling well. Had fallen 2 weeks prior to admission and lan... Read more
Presented to ED with 2 weeks of SOB, not feeling well. Had fallen 2 weeks prior to admission and landed on her back. Was hypoxic on admission and required 10 L of supplemental oxygen to maintain saturations > 90%. Was transferred to this facility for further care. SARS-CoV-2 test was positive at OSH (PCR + but antigen test negative) and PCR test + here. CXR suspicious for multifocal PNA consistent with COVID-19. Currently admitted.
74 2021-07-01 heart rate increased Severe vertigo in lying and standing positions with headache, nausea and vomiting that lasted about ... Read more
Severe vertigo in lying and standing positions with headache, nausea and vomiting that lasted about 12 hours. Rapid pulse and blood pressure of 178/74. Symptoms resolved with no treatment. Patient felt fine by late morning as if nothing had happened.
74 2021-07-12 oxygen saturation decreased pt called to report shortness of breath with limited activity (on o2, her sats drop to 85) since her... Read more
pt called to report shortness of breath with limited activity (on o2, her sats drop to 85) since her shot last thursday; also reports worsens when lying down, did report to her doctor and has appt tomorrow
74 2021-07-14 atrial fibrillation, palpitations, fast heart rate, heart rate increased On 3/20/2021 I was awakened from sleep with a rapid and pounding heart beat. No chest pain, no short... Read more
On 3/20/2021 I was awakened from sleep with a rapid and pounding heart beat. No chest pain, no shortness of breath. I finally called 911 about 5:30 AM and was transported to the ED at Hospital. After 8 hours of observation and no arrythmias other than tachycardia I was discharged and referred to a Cardiologist and my primary care Dr. I asked if this could be Vaccine related in the ED, Cardiologist's office and Primary care's office. I was told no because it was 10 days since I had the 2nd dose. The subsequent work up was negative except for the heart monitoring.(ssee below) MRI of heart 5/25/2021 normal
74 2021-07-14 cardiac failure congestive Patient admitted for CHF/Asthma exacerbation. Given Diuretics, albuterol, oxygen and steroids. Patie... Read more
Patient admitted for CHF/Asthma exacerbation. Given Diuretics, albuterol, oxygen and steroids. Patient's shortness of breath was felt to be multi-factorial including asthma exacerbation, mild CHF exacerbation, and mild COVID-19 pneumonia. Inpatient medications improved the patients condition and she was discharged on dexamethasone and albuterol, advair and spiriva after a short 2 day stay. Found to be COVID positive on admission.
74 2021-07-15 loss of consciousness after her first shot on FEB 24 she began looking white as ghost. She was very weak, unstable, in pai... Read more
after her first shot on FEB 24 she began looking white as ghost. She was very weak, unstable, in pain, and felt like her life force was getting drained out of her. Then her 2nd shot on MAR 24 and she continued to not feel good. On May 9th she lost consciousness on the bathroom floor, rushed to the ER. She was admitted and told she had pneumonia. By that evening she could not breathe. Her lungs filled with blood and she was dead within 6 days.
74 2021-07-18 excessive bleeding Moderna vaccination 1- Feb. 19 Cataract surgery & black eyes, bruising-Feb. 25 Moderna vaccination ... Read more
Moderna vaccination 1- Feb. 19 Cataract surgery & black eyes, bruising-Feb. 25 Moderna vaccination 2- March 18 Root canal & bruising and bleeding- March 22 Spontaneous knee bleed & bruising-April 10 June 22, 2021- Hand Surgery with DDAVP prior 7/7/21- Called office with increased bruising and pain. Started Amicar DDAVP IV 7/8/21 & 7/13/21
74 2021-07-18 inflammation of the heart muscle, stroke, inflammation of the pericardium, troponin increased Adverse effects started approximately 12:00am the night of the second vaccine. The AE's included co... Read more
Adverse effects started approximately 12:00am the night of the second vaccine. The AE's included cough, temperature of 101.2F, total body aches and required best rest for approximately 36 hours. This was followed by the development of a chronic, persistent and deep cough. Previous to receiving the vaccine I was being treated for diverticulitis in January of 2021 and it was noticed that I had slightly elevated eosinophils (~1000). After the second vaccine dose the cough continued to worsen and get deeper and more persistent. At the end of March I was referred to a pulmonogist and it was found my absolute eosinophil count was 130000 and I was sent to ER for treatment. After admission, I was referred to the Cancer center for further outpatient treatment. During my outpatient treatment (March 24- April 30) I slowly developed paraplegia to the state where in could no longer walk After numerous tests including bone marrow biopsy, thoracic and abdominal CT scans, 3 brain MRI's several parasite tests no specific cause of the high eosinophils was determined. Additionally, multiple organs were effected including infractions in the brain, high tropinin levels (pericarditis/myocarditis?) requiring echo cardiogram , TEE, and angiogram, as well as bowel resection resulting in an ostomy (May 1, 2021). All together, I required major surgery for a life threatening condition, spent 7 days in ICU, 7 days in the hospital surgical unit, 20 days in a rehab facility, and an additional 3 weeks in a nursing and rehab unit. I am still recovering and receiving home care and rehab. As there was no discoverable cause of the hyper-eosiniphilia, it is my strong belief that the Moderna Covid vaccine (2nd dose) was a significant contributing factor, an accelerant and/or the root cause of the hyper-eosiniphilia and the subsequent events unfolding. It seems highly probable that the vaccine is the cause and further investigation should be conducted.
74 2021-07-19 hypotension Dehydration; Conditions worsensing; lowered her BP; Dementia woresened; Weakness; became weak and ha... Read more
Dehydration; Conditions worsensing; lowered her BP; Dementia woresened; Weakness; became weak and had trouble inhaling her inbrija having more problems within the last few days since she got her 2nd covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (Dementia woresened), DEHYDRATION (Dehydration), CONDITION AGGRAVATED (Conditions worsensing) and HYPOTENSION (lowered her BP) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product LEVODOPA (INBRIJA) for Parkinson's disease. The patient's past medical history included Dehydration. Concurrent medical conditions included Parkinson's disease, On and off phenomenon, Non-tobacco user, Hypotension and Dementia. Concomitant products included CARBIDOPA, LEVODOPA (RYTARY) for Parkinson's disease, CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) for an unknown indication. On 04-Feb-2021, the patient started LEVODOPA (INBRIJA) (unknown route) 42 milligram twice a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEMENTIA (Dementia woresened) (seriousness criterion medically significant), DEHYDRATION (Dehydration) (seriousness criterion hospitalization), CONDITION AGGRAVATED (Conditions worsensing) (seriousness criterion hospitalization), ASTHENIA (Weakness), DEVICE DIFFICULT TO USE (became weak and had trouble inhaling her inbrija having more problems within the last few days since she got her 2nd covid vaccine) and HYPOTENSION (lowered her BP) (seriousness criterion hospitalization). At the time of the report, DEMENTIA (Dementia woresened) and DEHYDRATION (Dehydration) outcome was unknown and CONDITION AGGRAVATED (Conditions worsensing), ASTHENIA (Weakness), DEVICE DIFFICULT TO USE (became weak and had trouble inhaling her inbrija having more problems within the last few days since she got her 2nd covid vaccine) and HYPOTENSION (lowered her BP) was resolving. No treatment information was provided. On an unknown date, the patient had developed low blood pressure. This case concerns a 74-year-old female with adverse events of Dehydration, condition aggravated, asthenia, device difficult to use and Dyspnea and was subsequently hospitalized after unknown days of Latency after mRNA-1273 vaccination and with co-suspect Levodopa (Inbrija) for Parkinson's Disease. There is very limited information available as temporal association cannot be established (missing dates of administration of both Moderna COVID Vaccine and Levodopa).; Sender's Comments: This case concerns a 74-year-old female with adverse events of Dehydration, condition aggravated, asthenia, device difficult to use and Dyspnea and was subsequently hospitalized after unknown days of Latency after mRNA-1273 vaccination and with co-suspect Levodopa (Inbrija) for Parkinson's Disease. There is very limited information available as temporal association cannot be established (missing dates of administration of both Moderna COVID Vaccine and Levodopa).
74 2021-07-21 heart attack Heart Attack after vaccination; This spontaneous case was reported by a consumer and describes the o... Read more
Heart Attack after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack after vaccination) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (Heart Attack after vaccination) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart Attack after vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication use was not reported. Treatment information was not reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
74 2021-07-22 blood pressure increased Face began to swell all around mouth and most of right side of face to swell and blurry vision. Swe... Read more
Face began to swell all around mouth and most of right side of face to swell and blurry vision. Swelling in her gums and around teeth. Inside of mouth felt bruised. Blood pressure was elevated when went to ER and when she went to dentist they had to take her BP 3 times and it was jumping all over the place
74 2021-07-23 cerebrovascular accident, heart rate increased Mouth swelling; face was starting to droop,feel paralysis in face; symptoms of a stroke; Bell's Pals... Read more
Mouth swelling; face was starting to droop,feel paralysis in face; symptoms of a stroke; Bell's Palsy; woke up with feeling of "swish and sip" in mouth,tingling in lips; tongue stuck out crooked; crick in neck on the left side; pain behind ear that kinda burned on the left side; mouth inflamed; Felt like lips on fire; Lips were swollen; rash around the edges of mouth; Corners of mouth dry, cracked and uncomfortable; mouth was really stiff; couldn't keep her lips lubricated; lips were really painful; Bad rash all over body; Hardness at injection site; Redness at injection site; swelling of the lymph nodes in the same arm of the injection; Injection site pain,tenderness; Swelling at injection site; Fatigue; Headache; Muscle Pain; Joint Pain; Chills; Nausea; Fever; Swelling of her face; Dizziness; Swelling throat; Fast heart beat; Weakness; Injection site felt hot; felt pretty sick for the first couple of days; This spontaneous case was reported by a patient and describes the occurrence of FACIAL PARALYSIS (face was starting to droop,feel paralysis in face), CEREBROVASCULAR ACCIDENT (symptoms of a stroke) and BELL'S PALSY (Bell's Palsy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Polycythemia vera (a form of blood cancer, for which she is on aspirin once a day. Patient initially diagnosed approximately 3 years ago.), Hypothyroidism, Allergy and Asthma ("a little" asthma due to environmental allergies.). Concomitant products included MONTELUKAST for Environmental allergy and Asthma, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, ASPIRIN [ACETYLSALICYLIC ACID] for Polycythemia vera. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced DIZZINESS (Dizziness), SWELLING FACE (Swelling of her face), PHARYNGEAL SWELLING (Swelling throat), HEART RATE INCREASED (Fast heart beat), ASTHENIA (Weakness), VACCINATION SITE WARMTH (Injection site felt hot), ILLNESS (felt pretty sick for the first couple of days), RASH (Bad rash all over body), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in the same arm of the injection), VACCINATION SITE PAIN (Injection site pain,tenderness), VACCINATION SITE SWELLING (Swelling at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). On 17-Apr-2021, the patient experienced LIP SWELLING (Lips were swollen), ORAL MUCOSAL ERUPTION (rash around the edges of mouth), ORAL DISCOMFORT (Corners of mouth dry, cracked and uncomfortable), ORAL DISCOMFORT (Felt like lips on fire), LIP PAIN (lips were really painful), INFLAMMATION (mouth inflamed), MUSCULOSKELETAL STIFFNESS (mouth was really stiff) and LIP DRY (couldn't keep her lips lubricated). On 12-Jul-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (crick in neck on the left side) and EAR PAIN (pain behind ear that kinda burned on the left side). On 14-Jul-2021, the patient experienced FACIAL PARALYSIS (face was starting to droop,feel paralysis in face) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (symptoms of a stroke) (seriousness criterion medically significant), BELL'S PALSY (Bell's Palsy) (seriousness criteria disability and medically significant), PARAESTHESIA ORAL (woke up with feeling of "swish and sip" in mouth,tingling in lips) and TONGUE DISCOMFORT (tongue stuck out crooked). On an unknown date, the patient experienced MOUTH SWELLING (Mouth swelling). The patient was treated with PREDNISONE for Bell's palsy, at a dose of 4 dosage form once a day; PREDNISONE for Bell's palsy, at a dose of 2 dosage form once a day; PREDNISONE ongoing since an unknown date for Bell's palsy, at a dose of 1 dosage form once a day; VALACYCLOVIR [VALACICLOVIR] on 14-Jul-2021 for Bell's palsy, at a dose of 1 dosage form (evening) and VALACYCLOVIR [VALACICLOVIR] for Bell's palsy, at a dose of UNK, tid. On 06-Apr-2021, DIZZINESS (Dizziness), SWELLING FACE (Swelling of her face), HEART RATE INCREASED (Fast heart beat), ASTHENIA (Weakness), RASH (Bad rash all over body), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PAIN (Injection site pain,tenderness), VACCINATION SITE SWELLING (Swelling at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown, VACCINATION SITE WARMTH (Injection site felt hot) had resolved. On 21-Jul-2021, ORAL MUCOSAL ERUPTION (rash around the edges of mouth) and LIP PAIN (lips were really painful) had resolved, LIP DRY (couldn't keep her lips lubricated) outcome was unknown. At the time of the report, FACIAL PARALYSIS (face was starting to droop,feel paralysis in face), CEREBROVASCULAR ACCIDENT (symptoms of a stroke), BELL'S PALSY (Bell's Palsy), LIP SWELLING (Lips were swollen), ORAL DISCOMFORT (Corners of mouth dry, cracked and uncomfortable), ORAL DISCOMFORT (Felt like lips on fire), PHARYNGEAL SWELLING (Swelling throat), ILLNESS (felt pretty sick for the first couple of days), PARAESTHESIA ORAL (woke up with feeling of "swish and sip" in mouth,tingling in lips), TONGUE DISCOMFORT (tongue stuck out crooked), INFLAMMATION (mouth inflamed), MOUTH SWELLING (Mouth swelling), MUSCULOSKELETAL STIFFNESS (mouth was really stiff) and VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in the same arm of the injection) outcome was unknown and MUSCULOSKELETAL STIFFNESS (crick in neck on the left side) and EAR PAIN (pain behind ear that kinda burned on the left side) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Heart rate: fast (High) Fast. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Further information is t expected. Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant follow up case: Additional events, concomitant medications and medical history was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Further information is t expected.
74 2021-07-26 cerebrovascular accident Stroke, was hospitalized for ten days
74 2021-07-26 loss of consciousness Was unconscious on the floor; Couldn't get up; muscle loss (rhabdomyolysis); Ear Infection; Fell on ... Read more
Was unconscious on the floor; Couldn't get up; muscle loss (rhabdomyolysis); Ear Infection; Fell on ground; Bad reaction to 2nd dose; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was unconscious on the floor) and RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Was unconscious on the floor) (seriousness criteria hospitalization and medically significant), RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)) (seriousness criterion medically significant), EAR INFECTION (Ear Infection), FALL (Fell on ground), VACCINATION COMPLICATION (Bad reaction to 2nd dose) and VERTIGO (vertigo). On an unknown date, the patient experienced MOBILITY DECREASED (Couldn't get up). At the time of the report, LOSS OF CONSCIOUSNESS (Was unconscious on the floor), RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)), EAR INFECTION (Ear Infection), FALL (Fell on ground), VACCINATION COMPLICATION (Bad reaction to 2nd dose), VERTIGO (vertigo) and MOBILITY DECREASED (Couldn't get up) outcome was unknown. Ear infection at the time and was given 5 days course of steroids and the unknown medications. for other events. The blood work, CT scan, MRI, and other tests were done but none of them could pinpoint it to the vaccine. Patient was hospitalized for 3 days. No concomitant medication was reported by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Further information is expected. This case was linked to MOD-2021-052530 (Patient Link). Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Further information is expected.
74 2021-07-26 pulmonary embolism Hives, Bilateral PE's
74 2021-07-28 fast heart rate Patient hospitalized for breakthrough infection from 7/15-7/19/21. She completed Moderna series: vac... Read more
Patient hospitalized for breakthrough infection from 7/15-7/19/21. She completed Moderna series: vaccine #1 on 2/20/21 and dose #2 on 3/20/21. Below is copied from discharge summary: "This is a 74-year-old female who presents to the hospital with fever chills sore throat diarrhea and loss of appetite. COVID-19 virus infection Patient has already been vaccinated for COVID-19 (Moderna). No need to continue dexamethasone No need for abx at this moment Sepsis-fever, tachycardia in setting of COVID-19 virus infection- obtain blood cultures, no antibiotics for now. Acute hypoxic respiratory failure secondary to COVID-19 virus infection albuterol MDI as needed Breathing RA Essential hypertension- resume outpatient blood pressure medications Patient is discharged in stable condition with stable vital signs. All questions regarding hospital course and plan of care after discharge have been answered to satisfaction."
75 2021-01-14 blood pressure increased Hot flush after 5 mins. Tingling in feet and numbness. Tingling in fingers. Raised blood pressure ... Read more
Hot flush after 5 mins. Tingling in feet and numbness. Tingling in fingers. Raised blood pressure 190/110 sustained for 1.5hrs. Went to ER. Results of Chest X-ray, EKG and blood tests normal. Feelings of agitation. BP 140/90 on discharge from hospital. BP lower but elevated. Took Alprazolan at night. Saw doctor next day. BP more normal, Doctorsaid she had the same reaction on Pfizer shots. BP elevated again that evening 149/90. Took Alprazolam. BP came down to 125/72. This morning BP higher again. Have taken another Alprazolam. Very concerned about second shot. Doctor advised no coffee, take Alprazolam and hour before, and BP med if BP elevates. I do not suffer with hypertension and take no meds for it!!!
75 2021-01-15 blood pressure increased Blurred vision, lightheaded, facial flushing, abnormally high blood pressure, fatigue
75 2021-01-17 blood pressure decreased Within 1 minute I started feeling a rush in my throat and a metallic taste, then a tingling in both ... Read more
Within 1 minute I started feeling a rush in my throat and a metallic taste, then a tingling in both arms. That subsided for a minute or two, then started again with a flush feeling down my body. Nurse took blood pressure 140/80. Breathing fine. Heart rate fine. Flush feeling started again, and blood pressure dropped to100/70. I was then given 50 mg of Benadryl and an ambulance was called. My blood pressure stabilized but I was very shaky. It was recommended that I go to the hospital for observation for a couple of hours, which I did. I only had the flush feeling once at the hospital. I was released after two hours.
75 2021-01-17 chest pain Patient received vaccine then proceeded to stand. Upon standing, patient reported back pain that bec... Read more
Patient received vaccine then proceeded to stand. Upon standing, patient reported back pain that became chest pain. She rated the pain a 5 on a scale of 0-10. The pain was located in the substernal area and was reported as feeling like something was crushing her chest. Patient given oxygen @ 10L via nasal canula and began feeling better after 10 minutes. EMS was contacted and transported to Hospital.
75 2021-01-17 chest pain Patient receive vaccine then proceeded to stand. Upon standing, patient reported back pain that beca... Read more
Patient receive vaccine then proceeded to stand. Upon standing, patient reported back pain that became chest pain. Pain level was rated 5 on scale of 0-10. Pain was located at substernal and described as crushing. Patient was given oxygen at 10L and began to feel better after 10 minutes. EMS contacted and transported to Hospital.
75 2021-01-20 coughing up blood, haemoglobin decreased, fibrin d dimer increased, low blood oxigenation Patient had COVID diagnosed and treated as outpatient on 12/24. She developed SOB with the infectio... Read more
Patient had COVID diagnosed and treated as outpatient on 12/24. She developed SOB with the infection and this persisted afterwards and did not resolve. She received first dose of Moderna vaccine and next day had fevers, myalgias, shortness of breath and hypoxia. She is now admitted to our facility with bilateral diffuse ground glass opacities and is severly hypoxic on high flow nasal cannula. She also has hemoptysis. procalcitonin is negative; BNP is normal; troponin normal.
75 2021-01-20 heart rate increased Following the shot, my face became hot, my ears were red, my tongue, arms, and legs tingled, heart r... Read more
Following the shot, my face became hot, my ears were red, my tongue, arms, and legs tingled, heart rate increased. This started shortly after the injection, It subsided after about 15 to 20 minutes. This is similar to reactions that I've had to flu vaccines when I last had one nearly 25 years ago. It is also similar to my reaction to numbing shots where epinephrine is in the shot.
75 2021-01-21 chest discomfort After receiving vaccine patient started to feel hot and face turning red. She reported feeling like ... Read more
After receiving vaccine patient started to feel hot and face turning red. She reported feeling like she was tight in the chest and throat was swelling. She said she had an epi pen with her. I asked her if she thought it was time to administer and call 911 she said yes. We proceeded. She said her throat was feeling a little better but chest was tight and she was having a dry cough. Ambulance took her to hospital. I called her around Noon the next day to check in on her and she said she was in hospital still being monitored. Was advised not to get second dose of vaccine from hospital.
75 2021-01-23 chest discomfort, hypertension, heart rate increased Vaccine administered at 4:30 pm on Jan 16, 2021: Ate dinner at 6:00 pm and began experiencing the f... Read more
Vaccine administered at 4:30 pm on Jan 16, 2021: Ate dinner at 6:00 pm and began experiencing the following symptoms: nausea with vomiting, extreme tightness in chest area, front and back, elevated blood pressure and heart rate. Went to ER , was treated for nausea and pain. Discharged at 1:40 am Jan 17, 2021. ***Doctor would not confirm that symptoms were result of vaccination, but I wanted to report.
75 2021-01-23 nosebleed patient called roughly 1 hour after getting vaccine indicating she was blowing her nose when it star... Read more
patient called roughly 1 hour after getting vaccine indicating she was blowing her nose when it started to bleed. It was a consistent flow and had been going on for 5 minutes before calling the pharmacy. She had placed a clip on her nose to see if it would stop, but when asked to check she said it still has not stopped. Asked her what medications she was taking and if she was on blood thinners. she indicated no. Looked up adverse events on Moderna covid-19 vaccine and it didn't indicate nose bleeding, package insert states "intentionally blank". Advised patient to head to the ER and I would call to check up on her.
75 2021-01-24 blood pressure increased Blood pressure elevation to 190/100
75 2021-01-24 chest pain 2:25 pm- Patient reports chest pain 8/10; shortness of breath; throat tightness
75 2021-01-25 heart rate increased low grade fever, tongue felt swollen, delirious, could not walk, nerve pain throughout body (especia... Read more
low grade fever, tongue felt swollen, delirious, could not walk, nerve pain throughout body (especially hands, down legs, feet), speech was slurred, fast heart rate,
75 2021-01-26 atrial fibrillation, heart rate increased, fainting syncopy episode Atrial fibrillation Rapid rate into the 180's
75 2021-01-26 blood pressure increased Hot flush starting from feet. Tingling and numbness in feet. Little tingling in fingers. Blood pre... Read more
Hot flush starting from feet. Tingling and numbness in feet. Little tingling in fingers. Blood pressure rose to 170-190 over 110 and would not go down. Doctor advised I go to the E.R. for assessment, which I did. Blood pressure remained elevated for days . Noted the systolic was higher , mostly in the 80's. I do not have hypertension BP this morning in the 120's over 70. Needed Alprazolam to calm my anxiety since. Not every day. Very concerned about having the second dose. Doctor has advised me to only drink water the day of shot, take a tranquilizer an hour before and has given me BP med to take if my BP goes over 150.
75 2021-01-26 pulmonary embolism Not sure if it has to do with the COVID vaccine but her caregiver reported to me today (1/27/20201) ... Read more
Not sure if it has to do with the COVID vaccine but her caregiver reported to me today (1/27/20201) that she passed away on 01/16/2021 from a pulmonary embolism that was 18 days after vaccine
75 2021-01-27 blood pressure increased, heart rate increased Elevated heart rate (137) and elevated blood pressure (176/96). Lasted about 2 hrs. until I started... Read more
Elevated heart rate (137) and elevated blood pressure (176/96). Lasted about 2 hrs. until I started to calm down and took a Xanax .25mg
75 2021-01-27 blood pressure increased A hypertensive event: I walked from the injection station to a waiting area, by the time I arrived a... Read more
A hypertensive event: I walked from the injection station to a waiting area, by the time I arrived and took my seat I began to feel unwell and my body was disregulated. The on-duty nurse asked me if I was OK. I said I felt unwell, she retrieved the blood-pressure testing device. These are the resultsÂ… My blood pressure, normally ~119/71p51, spiked to 185/90p56, 2nd test was 166/80(?)p62, 3rd test was 175. Head felt pressure. Body felt chills alternating with heat. Chills with lack of energy persisted for 2 days. Blood pressure on 1/27 was: 98/62p44, 102/51p43, 98/62p44, 94/57p50.
75 2021-01-28 blood glucose increased After vaccination blood sugar was extremely high, dropped to normal levels
75 2021-01-28 oxygen saturation decreased Fever, aches, chills, headache, vomiting, cough, congestion, lowered O2 level
75 2021-01-29 fainting Started with severe arm pain one day after injection. Second day, sweating, faint, weak for about 2... Read more
Started with severe arm pain one day after injection. Second day, sweating, faint, weak for about 2 hours then just weakness for rest of day. By third day I was fine.
75 2021-01-30 low blood pressure She had orthostatic hypotension and dizziness 2-3 hours post vaccination with blood pressure on stan... Read more
She had orthostatic hypotension and dizziness 2-3 hours post vaccination with blood pressure on standing of 70 systolic. She was observed in the hospital overnight
75 2021-01-31 hypertension, blood pressure decreased Nausea, vomiting, flushing, sweating, redness of face, hands chest, lower legs, high blood pressure ... Read more
Nausea, vomiting, flushing, sweating, redness of face, hands chest, lower legs, high blood pressure 180/102 pulse oximeter 97-99. Given 25 mg of benadryl as a liquid. Approximately 4:30 my oxygen level still good and blood pressure was down to 146/75 and pulse 74. Redness was fading. No other problems after this.
75 2021-02-01 heart rate abnormal Dizziness and lightheadedness. BP was 104/66, HR 81. Placed on a litter and placed in Trendelenburg... Read more
Dizziness and lightheadedness. BP was 104/66, HR 81. Placed on a litter and placed in Trendelenburg position. BP 94/59, HR 81, pulse ox 98%. BP in trendelenburg 126/71 Final bp 125/62, HR 65, pulse ox 99%. Placed in sitting position. BP was 118/63. Patient was cool to touch. Released after 30 minutes with no issues.
75 2021-02-02 blood pressure fluctuation Day after vaccination I woke up having similar symptoms as I did when contracted Covid19 in June 22n... Read more
Day after vaccination I woke up having similar symptoms as I did when contracted Covid19 in June 22nd , 2020 Chills, lethargy, tiredness, thirst, diarrhea, slightly elevated fever, dry cough which lasted 2.5 days. Then recovered and it lasted 3 days and woke up feeling dizzy in head. Sudden raise for blood pressure which kept fluctuating during 2 days, reaching at worst 199/103! Finally came down with doctor's help and adjusting some existing medication and adding Tylenol to the mix.
75 2021-02-04 blood pressure decreased Episodes of lightheadedness and nausea from Jan 17-21, 2021. Kept bp cuff on so I could measure bp a... Read more
Episodes of lightheadedness and nausea from Jan 17-21, 2021. Kept bp cuff on so I could measure bp at time of episode. Bp normally about 120/75, but during episodes bp would drop to numbers like 85/60. Within a couple minutes of episode, bp would return to normal.
75 2021-02-04 palpitations On 01/29/2021 was feeling Nausea, Chills and Diarrhea, fever 101.9, Patient states that she was not... Read more
On 01/29/2021 was feeling Nausea, Chills and Diarrhea, fever 101.9, Patient states that she was not able to keep anything down and took medication for the fever. On Monday 02/01/2021 patient was feeling weak and tired and felt like she has fast racing heart rate. Patient is feeling a lot better now. Patient was advised if new symptoms or symptoms return to go into UC or ER or give our office a call back.
75 2021-02-05 hypotension Fever 102, chills, low blood pressure 77/44, Total lasted about 18 hours. Took Tylenol
75 2021-02-08 heart rate abnormal DISCOVERED UNRESPONSIVE WITHOUT PULSE, RESPIRATIONS, HEART BEAT ON 2/7/21 AT 0435 A.M. RESIDENT WAS ... Read more
DISCOVERED UNRESPONSIVE WITHOUT PULSE, RESPIRATIONS, HEART BEAT ON 2/7/21 AT 0435 A.M. RESIDENT WAS DNR STATUS.
75 2021-02-10 chest pain Shivering (1/2 hour+) , extremely painful movement, headache, sore throat, fatigue, painful shoulder... Read more
Shivering (1/2 hour+) , extremely painful movement, headache, sore throat, fatigue, painful shoulders and neck, body aches, low grade fever. I have been experiencing a sore throat and headaches, dizziness, weakness, and breathing okay but chest hurt. Ran through the most extreme of these within a 24-period. Still lingering is headache, sore throat, body aches, very painful neck and shoulder area.
75 2021-02-10 lightheadedness Patient had a vagal episode. Patient has an extensive medication history, comorbidities, and health ... Read more
Patient had a vagal episode. Patient has an extensive medication history, comorbidities, and health conditions. Patient did not eat breakfast and presented hypoglycemic. Patient was given water, glucose, and 911 was called. No transient sequelae.
75 2021-02-11 cardio-respiratory arrest Resident reviewed for incident. Resident received the second dose of the Moderna Covid-19 vaccine lo... Read more
Resident reviewed for incident. Resident received the second dose of the Moderna Covid-19 vaccine lot# 016M20A Exp 5/2/2021 on 2/5/2021 from clinic through pharmacy. Resident had her temp/O2 taken on AM shift and was 98.6/93%, beginning PM shift 98.4/95%. A few hours later noted that resident to have chills and was shaking RN assessment completed and vitals taken resident noted to have temp of 102.2, oxygen 95%, pulse 110. Resident alert and oriented at that time and talking to staff. Reported findings to APNP with order to send to ER. 911 called, residents brother updated. Upon EMT arrival RN went down to residents room with EMT and resident had an emesis as resident was getting cleaned up resident went unresponsive. Pulse noted to still be present at that time, resident did briefly respond to sternal rub and then went unresponsive again. Resident full code and EMT transferred to gurney and said that if they lost a pulse in route that they would transfer to hospital B instead of hospital A being the closest facility. RN called brother and gave update. Facility notified from Hospital that resident had passed away.
75 2021-02-11 loss of consciousness, fainting Received dose on Tuesday, felt fine besides sore arm and body aches. Then on Thursday evening betwee... Read more
Received dose on Tuesday, felt fine besides sore arm and body aches. Then on Thursday evening between 7 and 9pm, patient fainted with no warning signs. Patient was talking to sister on the phone and sister states she was confused. Patient is not sure how long she was unconscious for. Patient hit the back of her head and hurt her left arm. Her head bled a little bit. She denies headache. She is sore from the fall, she still has a sore arm and body aches. She checked her blood pressure this morning, 2/12/21, is was 139/88 and pulse 95. Patient has not gone to an urgent care yet to get checked out. Recommended patient contact doctor and be seen right away. She will contact urgent care as soon as we are off of the phone.
75 2021-02-14 blood pressure decreased, loss of consciousness, blood glucose increased, hypotension Patient is a 75 year old female who has completed a 2 hours observation period with the following si... Read more
Patient is a 75 year old female who has completed a 2 hours observation period with the following signs and symptoms of an adverse reaction; hypotension and loss of consciousness. Moderna COVID-19 vaccine #1 in series administered. 1318- pt. reported blurred vision to RN. Pt immediately assessed, during assessment pt. temporarily lost consciousness. Vitals- O2 sat-96%, HR-55, B/P-55/27, resp-16; 1320-DOD called, recommendation was to send to the ER via 911; 1324- Paramedics arrived and assessed pts. blood sugar (167), vitals O2 sat-98%, HR-71, resp 16, BP-91/40. Paramedics stated transfer to hospital was not necessary, but offered, Pt. declined ambulance transfer to ER. 1330- Continued to monitor pt. while giving oral fluids. Pt. reports she has fully regained consciousness, and blurry vision has resolved. Vitals, BP-102/42, HR-73, O2sat-96%, resp-16; 1335- Vitals, BP-110/50, HR-82, O2sat-96%, resp-16; 1400- Vitals, BP-121/45, HR-66, O2sat-97%, resp-18; 1420- Vitals, BP-125/31, HR-66, O2sat-96%, resp-16, DOD advised pt. should be assessed by MD. Pt. continues to refuse transfer via ambulance, no family members present. 1440- Pt discharged. o Action(s) taken: Recommended transfer to higher level of care, risk and benefits explained to patient, patient declined ride from ambulance to ER and was discharged. o Patient advised to discuss second dose considerations with a clinician
75 2021-02-14 blood pressure increased, heart rate increased Onset began Thursday evening rapid heart rate and increased blood pressure. Headache and chills. una... Read more
Onset began Thursday evening rapid heart rate and increased blood pressure. Headache and chills. unable to do housework for 2 days.
75 2021-02-14 blood pressure increased Moderna COVID-19 Vaccine EUA. Patient reported pain in left eye after covid vaccine. Patient noted t... Read more
Moderna COVID-19 Vaccine EUA. Patient reported pain in left eye after covid vaccine. Patient noted to have elevated BP and redness/subconjunctival hemorrhage in left eye. persistent HTN. Allergist notified and Patient instructed to go to Emergency Dept. for further evaluation.
75 2021-02-14 loss of consciousness 48 Hours after receiving vaccine I woke up with sever vertigo and passed out briefly. Felt dizzy mos... Read more
48 Hours after receiving vaccine I woke up with sever vertigo and passed out briefly. Felt dizzy most of Saturday. Sunday morning about 1:00, I woke up with severe vertigo and could not sit up or stand up to go to the bathroom. My husband had to help me. I then experienced severe, repeated vomiting that lasted until 5:30 AM. I was sick and dizzy all day Sunday. Began feeling better that evening. Next day (today) I am much better. But I was desperately ill all Saturday night.
75 2021-02-15 arrhythmia, heart rate increased Day after treatment, fever of 100.5 degrees. Did not last long. during the night awakened several ... Read more
Day after treatment, fever of 100.5 degrees. Did not last long. during the night awakened several times with rapid heart rate as well as some arrhythmias. Was able to text my Cardiologist at 7am, who told me I was having a reaction to the vaccine. His wife had had the same reaction. After 72 hours, her adverse reaction was gone.
75 2021-02-15 atrial fibrillation rash, fever, muscle aches. headache, vomiting, could not eat, dehydrated, could not walk very well,... Read more
rash, fever, muscle aches. headache, vomiting, could not eat, dehydrated, could not walk very well, in bed for 6 days went into afib attack, trouble breathing, have oxygen at home
75 2021-02-15 haemoglobin decreased Had no reaction to 1st dose of Moderna COVID vaccine 1/6/2021. 2nd dose Moderna COVID vaccine 2/4/2... Read more
Had no reaction to 1st dose of Moderna COVID vaccine 1/6/2021. 2nd dose Moderna COVID vaccine 2/4/2021 had no immediate reaction but developed fever and fatigue that lasted 36 hr 1 d after vaccination. On 2/7 had redness and local swelling at site of injection. Next day 2/8 rash on chest then broke out face, neck , abdomen, back. Was seen in local ER where she was diagnosed with an allergic reaction to the vaccine. Treated Solumedrol, Toradol, lorazepam, Benadryl and Pepcid and dishcarged with Rx for Prednisone and advised to continue Benadryl and Pepcid. Rash worsened, became purple and morbilliform on face, arms, legs, back and abdomen over next 3 d. Was seen by PCP on 2/11. Prednisone increased to 40 mg x 3 d. Rash improved with this and was resolving by the time I examined her on 2/15/2021. Face was beginning to peel but had no mucosal surface involvement.
75 2021-02-17 blood pressure increased Weakness, dizziness, elevated Blood pressure. Was sent to the ER and admitted
75 2021-02-17 low blood pressure Fatigue, shakiness, orthostatic hypotension,
75 2021-02-17 palpitations within minutes of injection, c/o feeling like her heart was racing, feeling flushed, nausea, dizzine... Read more
within minutes of injection, c/o feeling like her heart was racing, feeling flushed, nausea, dizziness
75 2021-02-19 blood pressure increased When I woke up on Sunday morning, i was unable to put weight on my right foot. Had to use a chain. ... Read more
When I woke up on Sunday morning, i was unable to put weight on my right foot. Had to use a chain. Felt better that evening. Monday morning at 430 am woke up and could not get.up due to dizziness and nausea. Transported to hospital er. After examination and blood work was given meclizine and odestranon. Later nurse came in and said my potassium was so low that I had to have an IV and 2 large potassium tablets. Definitely a shock because blood work taken on Jan 21 showed potassium was fine. Never had a problem with low potassium in my life. My question to the emergency room physician how could this happen in a little over 3 weeks. He could not explain. A MRI was ordered and everything was ok. Sent home with medication. On Tuesday went to my Pcp office and was seen by another doctor in the practice because my doctor was out of the office. Still very dizzy. Blood pressure was up to 182. Again this is unusual. With my medication my pressure is usually 132 over 70 or 80. Blood work was taken. Later that evening it was reported that my iron was very low. Again never had this problem before. Left office with prednisone and now taking iron tablets. Forgot to say that when I left emergency room I was give potassium pills to take for three days. I am still dizzy and suffering from nausea. Prior to the shot, I was fine. No problems and no one can explain to me why I am still feeling horrible to include low energy level. Was told that I might have Vertigo. I informed the doctor that prior to July 2015 I did suffer with vertigo but not now
75 2021-02-19 heart rate increased, blood pressure increased PATIENT DIAGNOSED WITH SHINGLES 7 DAYS AFTER VACCINE -- THEN EMERGENCY ROOM VISIT FEB. 16TH OR 17TH... Read more
PATIENT DIAGNOSED WITH SHINGLES 7 DAYS AFTER VACCINE -- THEN EMERGENCY ROOM VISIT FEB. 16TH OR 17TH DUE TO HYPERGLYCEMIA, VERTIGO , DEHYDRATION AND ELEVATED BLOOD PRESSURE/HEART RATE
75 2021-02-19 palpitations Heart palpitations (not A-fib), lasted 2 hours
75 2021-02-19 ventricular tachycardia Heart went into v tac rhythm
75 2021-02-20 heart rate increased During the night following the vaccination, I experienced chills, aches, loss of bladder control and... Read more
During the night following the vaccination, I experienced chills, aches, loss of bladder control and extreme fatigue the following day. I have since had interim dizziness and rapid heart rate. My left arm is slightly swollen, red and sore.
75 2021-02-21 chest discomfort at 11:30 PM noticed increasing labored breathing with wheezing ; felt like a band was across chest;.... Read more
at 11:30 PM noticed increasing labored breathing with wheezing ; felt like a band was across chest;. Sat up in chair, concentrated on NOT gasping , as exhale was most difficult. Started to ease up around 5:30 AM and had totally cleared up by10:00 AM
75 2021-02-21 fainting I have had every effect listed on the paper of side affect including, difficulty of breathing, faint... Read more
I have had every effect listed on the paper of side affect including, difficulty of breathing, fainted, dizzy, nauseous, I have spent days in bed
75 2021-02-23 low blood platelet count, platelet count decreased ITP
75 2021-02-23 loss of consciousness Moderna COVID 19 vaccine ADR. Approximately 24 hours after receiving the vaccine on 02/09/21 the pa... Read more
Moderna COVID 19 vaccine ADR. Approximately 24 hours after receiving the vaccine on 02/09/21 the patient lost consciousness and fell. Upon awaking she discovered she vomited and defecated. She also reported joint pain and a low grade fever. These symptoms have now improved. This report was given by her daughter.
75 2021-02-24 loss of consciousness Passed out the morning after the vaccine which resulted in a broken ankle. I have never passed out b... Read more
Passed out the morning after the vaccine which resulted in a broken ankle. I have never passed out before
75 2021-02-27 nosebleed Spontaneous nosebleed upon awakening, temporary. This is unusual for me. There was also some slight... Read more
Spontaneous nosebleed upon awakening, temporary. This is unusual for me. There was also some slight blood in nose mucus soon after first dose.
75 2021-02-28 chest discomfort pt stated the morning she after she got the 2nd dose of covid vax she was light headed. She laid do... Read more
pt stated the morning she after she got the 2nd dose of covid vax she was light headed. She laid down later that night, when she got up she was dizzy and very light headed and she fell. Her husband helped her back to bed. She got up next morning and was still dizzy and light headed but she also felt weak in the chest, maybe SOB. These symptoms would come and go all day. Today 3/1/2021 she has tightness in chest along w/ a cough. Pt will see her PCP later today on 3/1/2021.
75 2021-02-28 fainting Adverse reaction began around midnight with chills, continued throughout the night alternating chill... Read more
Adverse reaction began around midnight with chills, continued throughout the night alternating chills and hot flashes, severe backache, muscle aches in thighs and general malaise. Got up around 8 to try to take a warm shower to ease muscle aches but as soon as I got into the bathroom I felt very hot, very nauseated and lightheaded. I suspected hypotension but of course I wasn't able to prove it at the time. I attempted to get back to my bed but had syncopal episode a few feet from the bed where I collapsed onto the floor. I just stayed on the floor and rested because it actually felt better lying down. I am a retired RN and suspect this adverse event was related to orthostatic hypotension. Nothing like this has ever happened to me before.
75 2021-02-28 fainting Near syncope-dizzy, lightheaded, diaphoretic, blurred vision, decreased responsiveness. Evaluated b... Read more
Near syncope-dizzy, lightheaded, diaphoretic, blurred vision, decreased responsiveness. Evaluated by EMS-BP 100 palp, BS 110, decreased responsiveness. 2:36 pm-transported by rescue squad.
75 2021-03-01 atrial fibrillation 2/1/21 noticed my heat rate was 140. Went to the hospital and was treated for atrial fibrillation.... Read more
2/1/21 noticed my heat rate was 140. Went to the hospital and was treated for atrial fibrillation. Went to ER 3 more times in February in atrial fibrillation with heart rate in 140s-150s.
75 2021-03-01 chest pain After approximately 10 minutes Pt started clearing her throat repetitively and complaining of chest ... Read more
After approximately 10 minutes Pt started clearing her throat repetitively and complaining of chest pain, shortness of breath and tingling/swelling if her tongue. Pulse Ox was taken and Pt was at 97% on room air and pulse of 84. 1st dose of Epi 0.3 mg given IM in left thigh at 1156, followed by IM injection in left thigh of Benadryl 50 mg. Pty placed on 2L O2 by nasal cannula. Lungs clear, Pt was not stridulous. EMS called and arrived at 7 minutes after injection of Epi. Pt transported to ED via ambulance, departed without incident.
75 2021-03-01 palpitations pt stated that she started getting a cough and scratchy throat soon after taking the covid vax. She... Read more
pt stated that she started getting a cough and scratchy throat soon after taking the covid vax. She also had a sore arm and her heart was beating harder that usual. Pt went to bed and woke up hot and feverish, she got up to use the bathroom and was unsteady on her feet and very disoriented. She had severe head fog and pain in her head, neck, shoulders and abdomen like her body was extremely inflamed. She would experience this every time she got up about which was about every 2 hours. She slept most of the day the next day and had swollen lymph nodes in her neck. She had fatigue and head fog for over a week. Pt had headache and dizziness yesterday 3/1/2021 on still has some fatigue today on 3/2/2021. Pt has not contacted her PCP at this time. Pt states she will not get another vaccine.
75 2021-03-02 palpitations I am a 75 year old female with severe Cardiomyopathy with an ejection fraction of less than 20% and ... Read more
I am a 75 year old female with severe Cardiomyopathy with an ejection fraction of less than 20% and an implanted defibrillator. I had my first COVID vaccine on Sunday, February 28. I had had sinus problems with a little runny nose the week before...no fever, no chills, normal temperature. Other than my arm being a little sore, i took two Tylenol the night of the vaccine and had no problems until Tuesday afternoon, March 2, 2021. i felt perfectly Sunday after =noon, all day Monday and Tuesday. However while shopping at a nearby store as I got to the checkout counter I started having shortness of breath, It was hard for me to walk and I was very shaky. I have an apple watch so I was able to check my heart rate. The heart rate was anywhere from 58BPM to 177BPM and all over place in between, i got in my car, trying to calm myself then called the EMTs. They took me to hospital to the Emergency Room. Several tests(see below) were performed. The final diagnosis was hear palpitations. They did a COVID test and I did test positive for the Rhino virus. The doctors didn't know if my incident was related to receive the COVID vaccine and my defibrillator was checked, and a test was run that indicated it wasn't bad enough to activate the defibrillator.
75 2021-03-03 loss of consciousness Severe sweating, blurred vision and passing out
75 2021-03-03 heart attack minor heart attack; stent put in; A spontaneous report was received from a consumer who was also a 7... Read more
minor heart attack; stent put in; A spontaneous report was received from a consumer who was also a 75 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a minor heart attack / myocardial infarction and stent was put in / stent placement. The patient's medical history was not provided. No relevant concomitant medications were reported. On 25-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection. On 13-Feb-2021, the patient experienced a minor heart attack and had a stent placement. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events, minor heart attack and stent was put in, was not provided.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
75 2021-03-03 pallor patient started to develop a headache a few hours after administration. the next morning the patien... Read more
patient started to develop a headache a few hours after administration. the next morning the patient woke up and her face was swollen (eyelids puffy, cheeks and jawline puffy), dizzy, weak, had chills and looked pale. She did not complain of trouble breathing, eating or drinking. symptoms resolved later that day on 3-3-2021
75 2021-03-03 fainting By 9:00pm I was feeling a little sick, like the flu. By morning I had a temp of 100.1 and felt very... Read more
By 9:00pm I was feeling a little sick, like the flu. By morning I had a temp of 100.1 and felt very sick but did not get out of bed. At 1;00PM I woke up and stood up out of bed and collapses onto the floor. I was unable to get up. I found my phone which had fallen onto the floor. I was shaking so bad I kept dropping it. I looked and my phone and was unable to figure out how to make a call. The screen did not make sense. Eventually I was able to call my daughter who decided to call 911. The paramedics came, picked me up off of the floor and helped me walk to the living room. My legs kept giving out like I was going to fall again. They were asking questions but I was unable to answer coherently. I was so confused. My brain was not working. They took me to the hospital where I was admitted and many tests were done.
75 2021-03-04 arrhythmia Patient said she experienced atrial flutter later that evening. She reported that it went back into ... Read more
Patient said she experienced atrial flutter later that evening. She reported that it went back into normal rhythm in a day and a half. She stated she would contact her cardiologist to discuss.
75 2021-03-04 blood glucose increased Office visit - NP Chief Complaint: seen today, 3/4/2021, complaining of or following up for Fever (s... Read more
Office visit - NP Chief Complaint: seen today, 3/4/2021, complaining of or following up for Fever (started today), Nausea (has nausea today), Abdominal Pain (c\o upper and lower abd pain has been constant for the last 3 days started on monday), Diarrhea (states she had diarrhea all day yesterday but has had no bm today), and Fatigue (pt states she is feeling very week today) . HPI Patient comes in to the office complaining of severe abdominal pain. States the pain started on Monday and was less severe, stating the pain has escalated to a 9/10 today and "unbearable." Pt. States she had diarrhea for a 24 hour period yesterday, but denies any bowel movement today. Patient also complains of severe fatigue and states nausea with emesis a "few times over the last 4 days." Patient states that on Tuesday her pain became "a little better," but states since that time it has worsened and is severe at approximately 1230 this morning." Patient states she did not go to the ER because she "knew she had an appointment today." BP 134/84 Pulse 104 Temp 101.6 °F (38.7 °C) Resp 20 SpO2 94% Abdominal: General: There is distension. Palpations: Abdomen is rigid. Tenderness: There is generalized abdominal tenderness. There is guarding and rebound. Comments: Tinkling bowel sounds noted to RLQ and RUQ with hypoactive bowel sounds to LUQ and LLQ. Abdomen is rigid and guarding and rebound pain are noted with examination. triaged to Emergency room: HPI 75 y.o. female who presents with complaints of right upper quadrant pain since Monday reports is moderate to severe sharp better right upper quadrant without radiation better with rest and worse with movement FINAL IMPRESSION ICD-10-CM ICD-9-CM 1. Calculus of gallbladder and bile duct with acute cholecystitis without obstruction K80.62 574.60 2. Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (HCC) A41.9 038.9 995.91 Final Disposition Transfer to Another Facility current inpatient at Hospital
75 2021-03-04 fainting Weakness, syncope, headache
75 2021-03-05 blood pressure increased, heart rate increased Evening of shot severe pain in rotator cuff area that lasted at least 36 hrs, It is still a bit sore... Read more
Evening of shot severe pain in rotator cuff area that lasted at least 36 hrs, It is still a bit sore there but, liveable..Rapid heartbeat along with blood pressure of 200/100, Fever reaching 102 degrees, chills, nausea. The nausea, chills lasted about 36 hrs. The fever which was eventually brought down by extra strength Tylenol around the clock after 12 hours. The increased hypertension which lasted for about three weeks was controlled by increased dosages of Vasotec at times to 20 mg. This required constant contact with Dr by text and phone.. Forgot to mention no black and blue or bruising at injection site but also pain at injection site for about one week.
75 2021-03-05 heart rate increased Rapid heartbeat accompanied by Bp of 195/90, bleeding under skin in huge area at vaccine site arm pa... Read more
Rapid heartbeat accompanied by Bp of 195/90, bleeding under skin in huge area at vaccine site arm pain. Bp was treated by increased dosage of Vasotec over a period of 2 weeks where it returned to normal. Bruise diminished slowly over 3 week period. Also after 8 day a skin rash appeared on the left arm, first as splotches that increased to a large area about 2 inches below vaccine site in a rectangular are for most of upper arm. It was red, itchy and burning. Only thing that released it was cortisone cream. It lasted several weeks. And only occurred for this first vaccine dose.
75 2021-03-07 heart rate irregular pt stated that about an hour after she got the covid vax she started get a sore arm and head ache. ... Read more
pt stated that about an hour after she got the covid vax she started get a sore arm and head ache. She had pain that moved from the sight of the injection down to her elbow. She has swelling and knots in her muscles down her arm and it is warm to the touch. The next day she developed flu like symptoms with bad chills without fever and eye pain. She has fatigue, brain fog, joint and muscle pain. She had SOB and was nauseated. On 3/7/2021 the chills were better but her eyes and head still just. She still had SOB and developed acid reflux. She said the pain and swelling of the arm is getting better today, 3/8/2021 but she has an irregular heart beat, dizziness, brain fog, SOB and headache. States she thinks her symptoms are starting to get better. Pt is going to contact her PCP regarding her symptoms and about getting her 2nd dose.
75 2021-03-07 hypertension During post vaccination observation became lightheaded and was hypertensive BP 200/90, did not impro... Read more
During post vaccination observation became lightheaded and was hypertensive BP 200/90, did not improve after 30 minutes and transferred to ED. Antihypertensive medication had not been taken for 2 days. Given antihypertensive medication with symptoms resolution. Discharged to home.
75 2021-03-07 fainting Fainting; Aches; Extreme Nausea; Chills; A spontaneous report was received from a consumer, concerni... Read more
Fainting; Aches; Extreme Nausea; Chills; A spontaneous report was received from a consumer, concerning a 75-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme nausea, chills, aches and fainting. The patient's medical history, as provided by the reporter, included COVID-19 infection on last March. Concomitant medications reported included atorvastatin and levothyroxine sodium. On 20Feb2021, approximately 4 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch nmber:015M20A) for prophylaxis of COVID-19 infection. On 20Feb2021, the patient experienced extreme nausea, chills, aches and fainting. Treatment for events included ondansetron and paracetamol. Action taken with mRNA-1273 in response to the events were unknown. The outcome of the events, extreme nausea, chills, aches were considered recovering/resolving. The outcome of the event, fainting, was considered recovered/resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
75 2021-03-07 fainting Patient started to experience dizziness almost immediately after receiving immunization. She did ev... Read more
Patient started to experience dizziness almost immediately after receiving immunization. She did eventually experience syncope after being put into a reclining position.
75 2021-03-08 chest pain Reaction: sharp chest pain Treatment: Patient advised to go to ER, patient left AMA. Outcomes: Did... Read more
Reaction: sharp chest pain Treatment: Patient advised to go to ER, patient left AMA. Outcomes: Didn't seek medical care because pain diminished. Reported feeling fatigued for a couple days after receiving the vaccine, but doing well other wise.
75 2021-03-09 blood pressure decreased extreme dizziness during the night; drop in blood pressure--Mon., 3/1, 7 a.m. 73/45 (67); 3/9, diz... Read more
extreme dizziness during the night; drop in blood pressure--Mon., 3/1, 7 a.m. 73/45 (67); 3/9, dizziness, 10 a.m. 79/44(74). This is very unusual for me. Until I was dizzy & checked my blood pressure on March 1, I didn't attribute the drop in Bp to the vaccine. But then I recalled the dizziness I experienced the night following the vaccine.
75 2021-03-09 loss of consciousness Shingles in the ear; Passed out; Couldn't mover her arm, head, legs, chest, felt paralyzed; Felt wea... Read more
Shingles in the ear; Passed out; Couldn't mover her arm, head, legs, chest, felt paralyzed; Felt weak; A spontaneous report was received from a consumer concerning a female patient of 75 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced loss of consciousness, paralysis, weakness and shingles in the ear. The patients medical history, as provided by the reporter, included myasthenia gravis. Concomitant medications reported included lidocaine patch and prednisone. On 10 feb 2021,prior to the onset of events, the patient received their first of two planned dose of mRNA-1273(Lot number:010M20A ) intramuscularly on an unknown arm for prophylaxis of COVID-19 infection. On 11 feb 2021, one day after vaccination,patient experienced loss of consciousness,paralysis and weakness. The event loss of consciousness and paralysis was also considered to be medically significant. On 16 feb 2021, patient experienced shingles in the ear. Treatment for the events included acyclovir and ice. Action taken with mRNA-1273 in response to the event was not reported. The outcome for the events loss of consciousness, paralysis, weakness and shingles in the ear were considered as unknown.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded.
75 2021-03-09 loss of consciousness blacked out
75 2021-03-11 blood pressure increased, chest pain about 10 min. my chest swelled up pain up and down arm pain in center of chest. half hour reported ... Read more
about 10 min. my chest swelled up pain up and down arm pain in center of chest. half hour reported to nurse, blood pressure was almost 200, stayed there about hour until blood pressure went down. during night arm swelled and wheezing in chest tool claudin allergy pill over 100 degree temp 2 days then second day about 3:30 pm hives started around my waist took allergy pill
75 2021-03-11 chest pain Patient presented to the ED on 3/9/2021 with chest pain, headache, and brief blurred vision. There w... Read more
Patient presented to the ED on 3/9/2021 with chest pain, headache, and brief blurred vision. There was no signs of stroke or MI event. Reason for admission: chest pain.
75 2021-03-11 hypertension She reports that she feels pain all over her body, reporting that her hands and feet feel stiff and ... Read more
She reports that she feels pain all over her body, reporting that her hands and feet feel stiff and tingly. She reports no weight changes, no cough, shortness of breath, PND, dysuria, swelling. Patient originally presented to the ED at hospital 3/1/2021 with a generalized body aches and pains of 1 day duration. In the ER, patient was hypertensive and labs showed elevated creatinine of 1.6 (baseline 1.27), BNP >8000. She describes her symptoms as a sub-acute onset hand and leg weakness. It appears that the leg symptoms started before the arms were affected, after which she developed positive sensory symptoms in the form tingling of the hands and feet. She also admits to negative symptoms in the form of decreased sensation of her feet. She has been unable to stand on her feet since about two days ago. She appears to have some disturbance in time perception as her recollection of the progression of her disease is off by several weeks. she denies bowel/bladder incontinence or saddle anesthesia.
75 2021-03-13 low blood oxigenation The day after the shot started coughing and short of breath which worsened until shortness of breath... Read more
The day after the shot started coughing and short of breath which worsened until shortness of breath was severe enough to go the ER on 3/9/21 at which time admitted to the hospital with fluid overload and hypoxia. Stayed in the hospital until 3/12/21, discharged home on oxygen and still coughing intermittently. Additional symptom of extreme fatigue.
75 2021-03-13 loss of consciousness Approximately 12 hours after receiving the vaccine, began feeling different with headache, body ache... Read more
Approximately 12 hours after receiving the vaccine, began feeling different with headache, body ache and chills. Upon arising in the morning at about 7:45 AM was not feeling well. Set down at the dining room table with my husband to take my temperature. While still sitting at the table my husband caught me as I was passing out/fainting. Bellevue paramedics were called and transported my to the hospital. I was alert during this time. i was transported to the Bellevue Nebraska Medical Center emergency room. After being checked out in the ER, I was admitted to the hospital for overnight observation. Released from the hospital about noon the next day. There were no adverse findings.
75 2021-03-13 fast heart rate Severe shortness of breath . Tachycardia with pulse of 167. Hospitalization & cardio version Itchy... Read more
Severe shortness of breath . Tachycardia with pulse of 167. Hospitalization & cardio version Itchy rash of left upper arm
75 2021-03-14 blood pressure increased, blood glucose increased She had been very busy after she got her vaccine, and by late afternoon she had been so tired, but h... Read more
She had been very busy after she got her vaccine, and by late afternoon she had been so tired, but her iron level is down. On 1/26/20 she was exposed to COVID and in Feb 20 had COVID vaccine and given inhalers, antibiotics and was sick until mid April with the virus especially with the coughing and extreme weakness. She never bounced back from the COVID 19 with possible pneumonia. She had a lot of pain everywhere that was very distinct. She then had nausea, diarrhea, a temperature of 99.7, runny nose like having a cold, itching really bad, and pretty much in bed for 2 days, her blood sugar and blood pressure went up when she was not eating anything as she had no appetite. She also had a slight headache. By the third day she felt much better.
75 2021-03-14 heart flutter Shaky, headache, brief heart flutter, queasy, tired, my joints ached, lower back hurt.
75 2021-03-14 chest discomfort patient stated that around 24 hours after the shot she got a fever and it lasted 3 days then on day ... Read more
patient stated that around 24 hours after the shot she got a fever and it lasted 3 days then on day 4 after the shot she felt a lot of pressure on her chest that lasted about 1 day then 3 or 4 days later she broke out in rash/sores on her face, chest and arms and some sores are still present
75 2021-03-14 chest pain Received the second dose of COVID 19 on Feb. 24, 2021, at 2:20 pm. After the injection, I sat for 1... Read more
Received the second dose of COVID 19 on Feb. 24, 2021, at 2:20 pm. After the injection, I sat for 15 minutes, felt fine, then left, went home. The next morning at 5 am, woke with right arm throbbing and a huge swelling where the vaccine was injected. I got up, felt dizzy, and went the the bathroom, took my temperature, which was 101 F, then got the chills and had chest pains across my entire chest. Tried to go back to bed but the symptoms got worse. Called my neighbor and asked him to take me to the ER. He took me to the ER and I was checked for fever, had a chest x-ray, urine test, blood pressure checked and at 5 PM was admitted.
75 2021-03-14 nosebleed, hypotension Horrific nosebleed; Blood pressure reading was 70/46 mmHg; Fatigue for a couple days, she was tired;... Read more
Horrific nosebleed; Blood pressure reading was 70/46 mmHg; Fatigue for a couple days, she was tired; Pain in the arm; A spontaneous report was received from a consumer concerning 75-years-old, female patient who experienced horrific nosebleed (epistaxis), fatigue for a couple days, she was tired (fatigue), pain in the arm (pain in extremity), and blood pressure reading was 70/46 mmHg (hypotension). The patient's medical history included nosebleeds, high blood pressure, and diabetes type-2. Products known to have been used by the patient, within two weeks prior to the event, included lisinopril, metformin, atorvastatin calcium, iron, and ascorbic acid. The patient received their first of two planned doses of mRNA-1273 (lot: not provided) intramuscularly for prophylaxis of COVID-19 infection on 20 Feb 2021, at 1:40 PM. On 21 Feb 2021, approximately at 9:00 morning, the patient was awakened by the feeling of something in her throat which she described as a horrific nosebleed. She stated that she was unable to stop the bleeding and went to an urgent care facility and was then transported to the hospital. On the same day, the patient reported that she was admitted, and her blood pressure reading was 70/46 mmHg. On 23 Feb 2021, she was released after two days of stay. The patient reported that the hospital did not provide an explanation for the cause of the nosebleed. The patient reported felt pain in her arm and felt fatigued for a couple of days after receiving her first dose of the vaccine. She stated that she felt that because she was tired and because she lost a large amount of blood due to her nosebleed, that was why she required hospitalization. The patient did not take blood thinners. The patient was feeling better now. On 20 Mar 2021, the patient was scheduled to have her second dose of the Moderna vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The events, horrific nosebleed (epistaxis), fatigue for a couple days, she was tired (fatigue), pain in the arm (pain in extremity), and blood pressure reading was 70/46 mmHg (hypotension), were considered resolving.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
75 2021-03-15 atrial fibrillation, arrhythmia Could not stabilize her heart rhythm; Heart beats per minute went up and down; build up of body flui... Read more
Could not stabilize her heart rhythm; Heart beats per minute went up and down; build up of body fluids; A spontaneous report was received from a consumer concerning a 75-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart beats per minute went up and down (atrial fibrillation) and could not stabilize her heart rhythm (arrhythmias). The patient's medical history included three-year history of atrial fibrillation and cardioversion. No concomitant medication were provided. On 21 Jan 2021, patient received her first of two planned doses of mRNA-1273 (Batch Number 042L20A) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, approximately one day prior to the onset of the events, patient received their second of two planned doses of mRNA-1273 (Batch Number 03/L20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Feb 2021, the patient's heart beats per minute went up and down from 73 bpm to 128 bpm. The patient stayed in atrial fibrillation for four days and on an unknown date the patient went to the Emergency Room (ER). On 24 Feb 2021, Wednesday the patient was admitted to the hospital. Cardioversion was performed to return heartbeat to a normal rhythm as patient's heart rhythm was not stable with intravenous (IV) medication. The patient was buildup of body fluid. Laboratory details included cardioversion. Treatment information for events could not stabilize her heart rhythm (arrhythmias) include Flecainide. Action taken with mRNA-1273 in response to the events heart beats per minute went up and down (atrial fibrillation) and could not stabilize her heart rhythm (arrhythmias) was not reported. The outcome of the events heart beats per minute went up and down (atrial fibrillation) and could not stabilize her heart rhythm (arrhythmias) was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
75 2021-03-16 stroke Reported to ER 3/14 with left facial numbness and left arm weakness, Labs, Chest x--ray and Ct brain... Read more
Reported to ER 3/14 with left facial numbness and left arm weakness, Labs, Chest x--ray and Ct brain completed, transferred to higher level care facility, Echo/MRI brain completed 3/15 with noted small acute infarct Right frontal region, facial numbness resolved, Right arm weakness continues but improving, PT/OT exercises given, Discharged 3/16 to home
75 2021-03-16 chest discomfort Chest tightness x 3 days the next day after receiving vaccine.
75 2021-03-16 haemoglobin decreased, anaemia acute nontraumatic left eg pain and extensive soft tissue bleed in leg/bruise with precipitous anemi... Read more
acute nontraumatic left eg pain and extensive soft tissue bleed in leg/bruise with precipitous anemia.noted in ER on 3/10 2/10/21 H&H HGB 13.1 HCT, AUTO 41.2 --at ER 3/10 RBC 3.06 M/mm3 LOW HGB 9.9 gm/dL HCT 29.3 % LOW PLT 382--medrol pack started AFTER condition commenced taken 3/8-13.
75 2021-03-16 pulmonary embolism bilateral pulmonary emboli
75 2021-03-17 loss of consciousness I woke up at 3am. Could not get back to sleep for 2 hours, so decided to drink some liqueur (Kahlu... Read more
I woke up at 3am. Could not get back to sleep for 2 hours, so decided to drink some liqueur (Kahlua). Because I very rarely drink alcohol, a little bit makes me sleepy. After about 4 sips, I broke into a cold sweat, could barely manage to stand up and call out to my husband. I then lost consciousness (and wet myself). (My husband caught me). I have never fainted or passed out in my entire life! I regained consciousness about 2 minutes later and then had the shakes for quite a while. For the next day and a half I felt as if a truck had run over me.
75 2021-03-18 chest pain, pulmonary embolism, deep vein blood clot Difficulty breathing; Chest pains; Blood clots in both of her lungs; Blood clots in both legs; Tired... Read more
Difficulty breathing; Chest pains; Blood clots in both of her lungs; Blood clots in both legs; Tired/ wiped out; A spontaneous report was received from a consumer (patient's daughter), concerning a 75-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced difficulty breathing (dyspnoea), chest pains, blood clots in both of her lungs (pulmonary embolism), blood clots in both legs (deep vein thrombosis), tired/ wiped out (fatigue). No medical history was reported. No concomitant medications were reported. On 03 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided). On 03 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient was completely wiped out for a couple of days following the vaccine. She was very tired and out of it. On an unknown date, over the weekend, the patient had difficulty breathing. On 08 Mar 2021, in the morning, the patient was hospitalized for chest pains and difficulty breathing. On the same day lab data revealed that she had blood clots in both of her lungs. On an unknown date, the patient had clots in both legs as well. She was hospitalized for a week and was in rehabilitation being monitored. The reporter also informed that the patient will be hospitalized until 18 Mar 2021 for the clots in both legs. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable. The outcome of the events of difficulty breathing (dyspnoea), chest pains, blood clots in both of her lungs (pulmonary embolism), blood clots in both legs (deep vein thrombosis), tired/ wiped out (fatigue) was unknown. The reporter did not provide assessment for the events of difficulty breathing (dyspnoea), chest pains, blood clots in both of her lungs (pulmonary embolism), blood clots in both legs (deep vein thrombosis), tired/ wiped out (fatigue). Follow-up received on 16 Mar 2021 included hospitalization end date, date of first dose of vaccine.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
75 2021-03-18 fluid around the heart, heart rate increased, hypotension, oxygen saturation decreased severe internal bleeding fluid build up around lungs/heart high heart rate low blood pressure low ox... Read more
severe internal bleeding fluid build up around lungs/heart high heart rate low blood pressure low oxygen liver failure death
75 2021-03-18 fainting Fainted suddenly the morning after receiving the vaccine. I couldn't get off the floor. I had no str... Read more
Fainted suddenly the morning after receiving the vaccine. I couldn't get off the floor. I had no strength and I was covered in sweat. I felt pretty bad the rest of the day and stayed in bed. I was lethargic for a couple days.
75 2021-03-19 loss of consciousness I had a complete memory blackout, starting at around 10pm, with no memory at all of going to bed or ... Read more
I had a complete memory blackout, starting at around 10pm, with no memory at all of going to bed or normal my bedtime routine, but on waking in the morning, discovered that I had not done things I always do - like taking out my contact lenses or turning off the TV.
75 2021-03-23 oxygen saturation decreased, pallor Pt had injection site redness and pain in left arm for several days. Pt also struggled with worsenin... Read more
Pt had injection site redness and pain in left arm for several days. Pt also struggled with worsening symptoms of anxiety and SOB and severe headaches. Pt had several episodes of respiratory distress and confusion and o2 sats dropping into the 60s. Pt a hospice patient and family did not choose to send out to hospital. Pt also had behavioral changes for weeks in addition to the new onset of confusion, pt became agitated and somewhat hostile. Symptoms managed with duo-nebs for SOB as well as morphine and ativan prn for agitation/anxiety/SOB. Pt has lost weight since vaccination and has become very pale. Severe symptoms are subsiding after several weeks, but pt still c/o SOB increased from before vaccine, HA that were new onset after vaccine, and neck pain. Pt did have some issues after first vaccine, but the above symptoms really onset after 2nd vaccine
75 2021-03-24 blood pressure increased, hypertension After 18 minutes my face started to swell, was seen by medical personal, Blood Pressure was 225/110.... Read more
After 18 minutes my face started to swell, was seen by medical personal, Blood Pressure was 225/110. I was monitored for some time, Blood Pressure started coming down so they let me leave. The Dr asked when I was seeing my Dr. And I told them the next day. I went to the Dr. The next day and my Bllod Pressure was still 225/100, was told to go to the emergency room. Went there and the Dr. At the hospital was convinced it was my heart, After all the test she gave me 2 Prednisone 20 mg. Discharge Diagnosis Allergic Reaction, Asymptomatic hypertension. I took Benadryl when I got home for about 5 days. It has been about a month and I'm almost feeling normal. Had Covid arm on day 8, swelling and pain. Have had chills, and body aches. Felt like I had had 10 cups of coffee.
75 2021-03-24 low blood oxigenation Patient reportedly received first dose of COVID vaccine (unknown manufacturer or lot #) on 2/2/21. ... Read more
Patient reportedly received first dose of COVID vaccine (unknown manufacturer or lot #) on 2/2/21. Patient was tested for COVID on 2/8/21 and resulted positive. Patient was transfered to our hospital on 2/14/21 with complaints of hypoxemia and COVID 19 infection. Patient required intubation, convelescent plasma, and 10 days of remdesivir therapy. Additionally patient was treated with levofloxacin, Zosyn, Augmentin, and vancomycin. By 2/19/21 patient was extubated and recovering from COVID illness. By 3/19, the patient was discharged home.
75 2021-03-25 atrial fibrillation Headache, fatigue, redness at injection site.
75 2021-03-30 blood glucose increased c/o increased confusion, lethargy, weakness, urinary incontinence
75 2021-03-31 ischemic chest pain Angina happened in jaw and chest; A spontaneous was received from a consumer, concerning herself, a ... Read more
Angina happened in jaw and chest; A spontaneous was received from a consumer, concerning herself, a 75 years old female patient who received Moderna's COVID-19 vaccine and experienced angina/angina pectoris. The patient's medical history included open heart surgery for cardiovascular problems. Concomitant medications prn nitro sublingual. On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273. On 25-MAR-2021, the patient received their second of two planned doses of mRNA-1273 (Batch no: 006B21A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 25 Mar 2021, 20 minutes after the second dose of vaccine, while driving patient experienced chest and jaw pain, self treated with nitro under the tongue and it went away after 15 min and was able to continue driving. The angina made her tired, restless and was afraid that she might have another one. Action taken with mRNA-1273 in response to event was not applicable. The outcome of the event angina was considered resolved.; Reporter's Comments: Based on reporter's complaints and history of heart surgery with recurrent angina the event is assessed as unlikely related to mRNA-1273. Further information has been requested.; Sender's Comments: MOD-2021-057914:Case for first dose
75 2021-03-31 cerebrovascular accident Patient had a stroke. Did not have any side effects leading up to the stroke event.
75 2021-03-31 lightheadedness muscle aches; weakness; lack of appetite; tiredness; fever; feelings of passing out; stomach crampin... Read more
muscle aches; weakness; lack of appetite; tiredness; fever; feelings of passing out; stomach cramping; nausea; dry heaves; hot flashes; hot sweats; feeling the need to defecate; headache; body ache; A spontaneous report was received from a consumer concerning a 75 year old, female patient who experienced stomach cramping/abdominal pain lower, nausea, dry heaves/retching, hot flashes/ hot flush, hot sweats/hyperhidrosis, feelings of passing out/loss of consciousness, feeling the need to defecate/defaecation urgency, tiredness/ fatigue, headache, body ache/ pain, fever/pyrexia, lack of appetite/ decreased appetite, weakness/ asthenia and muscle aches/myalgia. The patient's medical history included esophageal cancer and kidney failure. Products known to have been used by the patient, within two weeks prior to the event, included tylenol and cyanocobalamin injections. On 20 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 003B21A) intramuscularly in the left arm (deltoid) for prophylaxis of COVID-19 infection. The patient had sudden onset of stomach cramping, nausea, dry heaves, hot flashes, hot sweats, feelings of passing out, and feeling the need to defecate beginning two hours post administration. The episode lasted approximately 4-5 minutes, and she felt better after she was finally able to produce a bowel movement (indicates BM had a horrible odor). The patient began experiencing additional symptoms of tiredness, headache, body aches, and fever during the night of 20 Mar 2021. The patient administered Tylenol to alleviate her symptoms and returned to bed. The patient reported sleeping the entire day 21 Mar 2021 and had little to no appetite. the patient had headache and fever resolved 21 Mar 2021 during the afternoon hours. The patient had continued tiredness and weakness lasting throughout the day on 22 Mar 2021. Her symptoms prevented her from performing her work obligations on 22 Mar 2021. The patient was feeling better on 23 Mar 2021 other than muscle aches. The event feelings of passing out was considered as medically significant. Treatment for the event included Tylenol. Action taken with mrna-1273 in response to the events was not provided. The events, stomach cramping, nausea, dry heaves, hot flashes, hot sweats, feelings of passing out, feeling the need to defecate, tiredness, headache, body ache, fever, lack of appetite, and weakness, were considered resolved. The outcome of event, muscle aches was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
75 2021-03-31 fainting Collapsed; head injury from hitting the corner of the cabinet; dizzy; Lumbar contusion; she didn't f... Read more
Collapsed; head injury from hitting the corner of the cabinet; dizzy; Lumbar contusion; she didn't feel so good; A spontaneous report was received from a consumer concerning a 75 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced syncope, collapsed (syncope), head injury from hitting the corner of the cabinet (head injury), didn't feel so good (feeling abnormal), dizzy, and lumber contusion (bone contusion). The patient's medical history was not provided. No relevant concomitant medications were reported. On 19 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route for prophylaxis of COVID-19 infection. On 18 March 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 040A21A) via unknown route for prophylaxis of COVID-19 infection. On 20 March 2021, she was dizzy and passed out and ended up on the floor unconscious and was taken to the ER in an ambulance. The patient had a CT scan done and was diagnosed with syncope, head injury from hitting the corner of the cabinet and lumbar contusion.No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. At the time of this report, the outcome of the event syncope, collapsed (syncope), head injury from hitting the corner of the cabinet , didn't feel so good were not reported. The events dizzy and lumber contusion were not recovered.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
75 2021-03-31 fainting Client was in observation for 30 minutes after vaccination. At 29 minutes client had near syncope ev... Read more
Client was in observation for 30 minutes after vaccination. At 29 minutes client had near syncope event with shortness of breath. On-site EMS evaluated and called for transport and client was transferred to nearest emergency room.
75 2021-03-31 fainting Patient said the day after her shot, she woke up and was feeling very dizzy. In her kitchen, she t... Read more
Patient said the day after her shot, she woke up and was feeling very dizzy. In her kitchen, she turned and fainted, hitting her head on the counter and causing a concussion.
75 2021-04-01 cerebrovascular accident Diagnosed with Mild Stroke; Forgetfulness; A spontaneous report was received from a consumer concern... Read more
Diagnosed with Mild Stroke; Forgetfulness; A spontaneous report was received from a consumer concerning a 48-year-old, female patient, who experienced no movement in her eft arm, all the way to her hand and felt no movement in lip or chin. She experienced numbness on the side of her face and was forgetful and Forgetfulness. The patient's medical history was not provided. Products known to have been used by patient, within two weeks prior to the event, included atorvastatin calcium, acetylsalicylic acid, sodium alginate, sodium bicarbonate, vitamin d and antidepressants. On 12-FEB-2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12-MAR-2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 003A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 14-MAR-2021, approximately two days after receiving her vaccine, the patient began experiencing no movement in her left arm, all the way to her hand and felt no movement in lip or chin. She experienced numbness on the side of her face and was forgetful. The patient went to the hospital and was diagnosed with a stroke and felt forgetfulness. On 16-MAR-2021, the patient was discharged from hospital. She was able to use her arm, although her hand was still stiff, and her fingers could move. Treatments for the events was not reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, cerebrovascular accident and forgetfulness was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
75 2021-04-04 arrhythmia, palpitations Evening of vaccine got arrhythmia (bigeminy) for about an hour. Drank Coke with aspirin and it st... Read more
Evening of vaccine got arrhythmia (bigeminy) for about an hour. Drank Coke with aspirin and it stopped. 3 days later my feet turned purple for about 5 hours gradually mottling and going away Both these never before or since Sore left upper arm still at 2 months. At first couldn't raise arm above head and extreme pain now only slight pain if roll over in sleep or rubbed.
75 2021-04-04 nosebleed spontaneous nose bleed
75 2021-04-05 blood pressure increased Pt. Had 1st dose of Moderna COVID-19 vaccine on 3/22/21 at 7:45am. Pt. States she stayed at the vacc... Read more
Pt. Had 1st dose of Moderna COVID-19 vaccine on 3/22/21 at 7:45am. Pt. States she stayed at the vaccine location for approx. 15 minutes after receiving the vaccine and felt no symptoms. Once pt. Got in her car to go home she developed a feeling of pressure building up in the right side of her face and head. Pt. States she ended up going to the ED and had a BP of 204 upon arrival. Pt. States she was give Clonidine and prior to discharge her BP was 146/54. Pt. Also reports having memory problems for 24 hours after receiving the vaccine. Pt. States she would try to say "Super center store name" and end up saying "another name" Pt. States she is not having any symptoms to be triaged for at this time - but ultimately wanted to make sure this adverse reaction was noted. Pt. States her PCP is aware and she has the correct follow-up at this time. From ED visit: CHIEF COMPLAINT: OTHER (got covid shot. has head pressure. did feel like throat was swollen for a few minutes, but that resolved. ) Assessment/Plan DIAGNOSIS at time of disposition: 1. Essential hypertension MEDICAL DECISION MAKING 75-year-old female presents today to the emergency department for evaluation of symptoms after receiving her 1st COVID-19 shot. Upon arrival to emergency depart patient is well-appearing and nontoxic. Vital signs reviewed. Patient is fairly hypertensive. She describes the symptoms coming on immediately after shot. Her neurologic examination is strong. I do not appreciate any evidence of allergic reaction at this time. Because of her hypertension here in the emergency department did assess basic labs. She is given 0.1 mg of oral clonidine. Blood pressure show significant improvement. Patient is feeling much better at this time. Certainly may have been a component of blood pressure here so I am unsure if this was related to her COVID-19 shot. I did discussed follow-up with primary care physician as well as return criteria. Patient is discharged in stable and improved condition. BLOOD PRESSURE SCREENING: Based on last blood pressure taken in the ED of 146/54, active Diagnosis of HTN, patient excluded from screening. Medications cloNIDine (CATAPRES) tablet 0.1 mg (0.1 mg Oral Given 3/22/21 2031)
75 2021-04-05 loss of consciousness SORE ARM; ITCHY ARM; FEVER OF 103.7 F; QUEASY; VOMITING; CHILLS; BLACKED OUT AND ASKED WHERE HER CLO... Read more
SORE ARM; ITCHY ARM; FEVER OF 103.7 F; QUEASY; VOMITING; CHILLS; BLACKED OUT AND ASKED WHERE HER CLOTHES WERE FROM AFTER HER DAUGHTER CHANGED HER CLOTHES; SHE COULDNT FOLLOW THE INSTRUCTIONS TO STAND UP/ KNEES BUCKLING; SHE GOT CONFUSED AND LOST HER ABILITY TO WALK AND SIT DOWN; LOST HER ABILITY TO WALK AND SIT DOWN; A spontaneous report was received from a consumer, a 75-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness, chills, queasy, vomiting, fever of 103.7F, sore and itchy arms, confusion, lost ability to walk and sit down, knees were buckling, blacked out. The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the events were quetiapine, atorvastatin 10mg, tramadol, hydrocodone/APAP 5/325mg, gabapentin 300mg, Tylenol PM 500mg, Voltaren cream, Miralax. On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030M20A) intramuscularly in the right deltoid muscle for prophylaxis of COVID-19 infection. On 11 Feb 2021, next day after exposure to the first dose, the patient experienced, chills, queasy, vomiting, fever of 103.7F which went down to 100F. On 12 Feb 2021 (Friday) the patient had sore and itchy arms and lost the ability to walk and sit down to extend that was carried to the bathroom. The patient got confusion, knees were buckling and even blacked out. Lab exam performed were reported as GRF-21%. Treatment for the event included Aleve and Nyquil. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, chills, queasy, vomiting, fever of 103.7F, sore and itchy arms, confusion, lost ability to walk and sit down, knees were buckling and black out was considered to be recovered/ resolved.; Reporter's Comments: This case concerns a 75-year-old female who had serious unexpected loss of consciousness, dysstasia, gait disturbance, confusional state and nonserious expected pyrexia, chills, nausea, vomiting, injection site pain, injection site pruritus. Event onset 3 days after first dose mRNA-1273. Treatment with naproxen. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
75 2021-04-05 lightheadedness, pallor A164 to a 75 y/o F c/c near syncope after receiving a Johnson & Johnson COVID vaccine. Pt St she has... Read more
A164 to a 75 y/o F c/c near syncope after receiving a Johnson & Johnson COVID vaccine. Pt St she has not had a vaccine since grade school due to having syncope type reactions and fear of needles. History of cardiac arrhythmia, no other medical issues. Upon arrival, Pt laying on floor with FD vaccination team members attending her. Pt a/ox4, GCS 15, St near syncope 10 minutes after injection. Pt St she is feeling much better now. FD vaccination team members St Pt was very nervous about the injection, became pale and sweaty 10 minutes post injection and had a near syncope. No falls reported today. Pt hemodynamically stable by our arrival with negative postural findings. Pt St she is feeling much better. Pt does not feel the need for TRX and agrees to wait with vaccination team for 30 minutes or until she feels 100%. Pt left in care of vaccination team. Near syncope after COVID vaccination injection Exam, vitals, history, Pt left with vaccination team.
75 2021-04-08 heart rate increased 4/1/21: Per EMS on site during observation after COVID vaccine administration client had altered lev... Read more
4/1/21: Per EMS on site during observation after COVID vaccine administration client had altered level of consciousness. Client had stable vital signs except for slightly elevated pulse rate. Client with history of reactions to vaccines. Client care transferred to ambulance for transport to Hospital for further evaluation of altered level of consciousness.
75 2021-04-12 atrial fibrillation, loss of consciousness Diagnosed with an A-Fib; She went to pick up a glass of water, and she does not remember dropping th... Read more
Diagnosed with an A-Fib; She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that; A very strange thing happened; Had a very violent reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with an A-Fib) and LOSS OF CONSCIOUSNESS (She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy and Allergy NOS (morphin). On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Diagnosed with an A-Fib) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that) (seriousness criterion medically significant), FEELING ABNORMAL (A very strange thing happened) and VACCINATION COMPLICATION (Had a very violent reaction). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with an A-Fib), LOSS OF CONSCIOUSNESS (She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that), FEELING ABNORMAL (A very strange thing happened) and VACCINATION COMPLICATION (Had a very violent reaction) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: atrial fibrillation (abnormal) Atrial fibrillation. Concomitant medications include natural fibroid 60 mg, Biestrogen (Hormone regulator). Treatment medication include unknown intravenous medication. Based on the current information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
75 2021-04-12 palpitations 2:15pm- Multiple ectopic contunious beets (100% pacemaker dependent), weakness, dizziness and confus... Read more
2:15pm- Multiple ectopic contunious beets (100% pacemaker dependent), weakness, dizziness and confusion, 2:35pm violent shaking when supine, ~2:40pm received EPI pen by nurse while supine. ~2:50 EMT arrived and taken to the emergency room.
75 2021-04-12 oxygen saturation decreased Stiffness, staring off, unable to communicate , unable to respond to commands, unable to feed self,... Read more
Stiffness, staring off, unable to communicate , unable to respond to commands, unable to feed self, keeping left hand clinched in a fist, shuffling gait. Low oxygen
75 2021-04-13 cerebral haemorrhage Acute brain hemmorhage
75 2021-04-13 fast heart rate, heart rate increased On the same day I received both the first and second shots, while resting, my watch alerted me to th... Read more
On the same day I received both the first and second shots, while resting, my watch alerted me to the fact my heart rate had gone up to 135+. I have had occasional bouts with tachycardia before but rarely. Maybe 5 or 6 times in the last year, but those times my heart rate returned to normal quickly. My Dr. was not aware of this issue, I had planned to talk to her about it when I have my annual physical since it was happening so rarely. I actually didn't even have a name for it until it happened after my first Covid shot, because at that time and when it happened after the 2nd shot, my heart did not return to it's normal rate (mid 60's) for at least 15 minutes and I was more concerned.
75 2021-04-14 superficial blood clot Superficial thrombophlebitis of right basilic vein. resolved with anti-inflammatory.
75 2021-04-15 chest discomfort Towards the end of 30 min observation time, patient reported feeling warm all over, sweaty, chest a... Read more
Towards the end of 30 min observation time, patient reported feeling warm all over, sweaty, chest and jawline tightness. Patient taken to monitoring area and placed on a continuous pulse ox. Saturations 95-99%. She verbalized feeling the same symptoms with the first dose. Vital Signs: 1245- 199/73 HR80 1250- 171/78 HR77 1255- 184/70 HR79 (At this time pt self-medicated with own supply of Exedrine) 1310- 171/75 HR75(At this time, patient stated she felt better and ok to go home)
75 2021-04-17 cerebrovascular accident, ischaemic stroke Patient was admitted with left sided weakness consistent with stroke. Stroke was nonhemorrhagic on C... Read more
Patient was admitted with left sided weakness consistent with stroke. Stroke was nonhemorrhagic on CT scan. MRI could not be done due to presence of pacemaker. Stroke is presumed embolic or ischemic, surprising given pt is on both pradaxa and plavix and is compliant.
75 2021-04-17 loss of consciousness In the middle of the night after second innoculation found myself on the floor next to my bed. I ha... Read more
In the middle of the night after second innoculation found myself on the floor next to my bed. I have no idea how I got there and was not aware of who I has or how I got there. I don't remember how I got to the floor and didn't remember falling out of bed. The next morning my right hip was very sore, so I concluded I had been unconcious ancd fell out of bed I'm reporting this on the hope that cases ofothers who had similar cases can help me understand. I believe my case is unusual and severe, I live alone and I could have been fatally injured
75 2021-04-19 cerebral haemorrhage Developed increased weakness and was admitted to Hospital. Was treated with plasmapharesis and durin... Read more
Developed increased weakness and was admitted to Hospital. Was treated with plasmapharesis and during treatment developed acute psychosis and paranoid delusions. Was transferred to the Geriatric Psychiatry Unit at Hospital in for further treatment. Around a week into that admission, she had a dramatic neurologic change and was found to have extensive dural vein thrombosis with ischemic and hemorrhagic events. She was started on heparin drip and sent to Unit for thrombectomy that was unsuccessful. She is currently intubated and comatose with plans for compassionate withdrawal of care soon. Family wanted this sequence of events to be related to the appropriate authorities to investigate if there is any link to the initial vaccination.
75 2021-04-19 heart rate decreased 75 year old female c/o shortness of breath post Moderna Covid19 vaccination. at 1325 PM a heartrate... Read more
75 year old female c/o shortness of breath post Moderna Covid19 vaccination. at 1325 PM a heartrate of 50 and O2 sat of 99% on RA 1338 pm ambulance called VS 207/94 60 28 respirations. Patient requested an ambulance. She was then placed on 10 lpm non-re breather mask. Reported that she was recently place on lopressor, Chart stated amlodipine stopped and started on lopressor and benicar for her blood pressure. Hx of anxiety GERD, uncontrolled hypertension, bursitis of both hips and a-fib Note: Patient is a poor historian Medications prilosec, hctz, lipitor, lopressor, and benicar. Allergies Pt denied Fire department arrived followed by ambulance. Patient placed on gurney and taken to the hospital. Oxygen removed by paramedic. Pt speaking in short sentences and very anxious. Husband followed the patient. (site supervisor) aware of situation
75 2021-04-19 low blood oxigenation, atrial fibrillation Patient diagnosed with Covid at Health center on 3/2/2021. Admitted to hospital on 3/19/2021 after ... Read more
Patient diagnosed with Covid at Health center on 3/2/2021. Admitted to hospital on 3/19/2021 after being found hypoxic, fever 104 and AMS. She was diagnosed with COPD exacerbation, Pneumonia and Pulmonary HTN. She was discharged 3/29/2021. She was evaluated on 4/1 2021 and appeared alert and oriented on oxygen 24/7. She was evaluated in the office on 4/5/2021 again with hypoxia, altered mental status, parkinsons type features and subsequently readmitted to the hospital. She was again dxd with COPD exacerbation, pneumonia, pulm HTN, afib with RVR. Patient discharged to rehab.
75 2021-04-19 blood clot Blood clot causing swelling, pain, redness in left leg from groin to ankle--sent for ultrasound from... Read more
Blood clot causing swelling, pain, redness in left leg from groin to ankle--sent for ultrasound from Vascular surgeon's office at.
75 2021-04-20 atrial fibrillation Patient presented to her regular office appt on 2/17/2021 with afib with RVR. Patient transported to... Read more
Patient presented to her regular office appt on 2/17/2021 with afib with RVR. Patient transported to the hospital for further work up.
75 2021-04-21 oxygen saturation decreased, blood pressure increased Patient began to feel dizzy ~10 minutes after receiving her second dose of the Moderna. She then con... Read more
Patient began to feel dizzy ~10 minutes after receiving her second dose of the Moderna. She then continued to decline in responsiveness however never lost consciousness. Her blood pressure was monitored (elevated upon 1st check, then upper limit of normal on second check) and oxygen saturation declined and patient was started on oxygen. EMS was called and patient was transported to the ER.
75 2021-04-22 loss of consciousness hurt her head; fell unconscious in the bathroom; trying to say few words; Flu like symptoms; chills ... Read more
hurt her head; fell unconscious in the bathroom; trying to say few words; Flu like symptoms; chills and teeth were shattering; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEAD INJURY (hurt her head) and LOSS OF CONSCIOUSNESS (fell unconscious in the bathroom) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (chills and teeth were shattering). On 07-Apr-2021, the patient experienced HEAD INJURY (hurt her head) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (fell unconscious in the bathroom) (seriousness criterion medically significant) and DYSARTHRIA (trying to say few words). The patient was hospitalized from 07-Apr-2021 to 08-Apr-2021 due to HEAD INJURY. On 06-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (chills and teeth were shattering) had resolved. On 07-Apr-2021, LOSS OF CONSCIOUSNESS (fell unconscious in the bathroom) and DYSARTHRIA (trying to say few words) had resolved. At the time of the report, HEAD INJURY (hurt her head) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported getting an IV and other medications in the hospital, however not aware of which medications were given for treatment.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information is required. Causality for the events flu-like symptoms and chills is possible.
75 2021-04-22 pallor kidney failure; not feeling well; shaking; pale; weak; headache; 101.5F fever; This spontaneous case... Read more
kidney failure; not feeling well; shaking; pale; weak; headache; 101.5F fever; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (kidney failure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Kidney failure on 14-Apr-2021. On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 14-Apr-2021, the patient experienced RENAL FAILURE (kidney failure) (seriousness criterion medically significant), MALAISE (not feeling well), TREMOR (shaking), PALLOR (pale), ASTHENIA (weak), HEADACHE (headache) and PYREXIA (101.5F fever). At the time of the report, RENAL FAILURE (kidney failure), MALAISE (not feeling well), TREMOR (shaking), PALLOR (pale), ASTHENIA (weak), HEADACHE (headache) and PYREXIA (101.5F fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5f (High) 101.5F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact
75 2021-04-26 cerebrovascular accident possibility of having a stroke; severe neurological symptoms; difficulty with her speech (can think ... Read more
possibility of having a stroke; severe neurological symptoms; difficulty with her speech (can think of the word, but could not get it out); she had gait problems; Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (possibility of having a stroke), NEUROLOGICAL SYMPTOM (severe neurological symptoms), SPEECH DISORDER (difficulty with her speech (can think of the word, but could not get it out)) and GAIT DISTURBANCE (she had gait problems) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included AMLODIPINE, MORPHINE SULFATE, AMITRIPTYLINE, METFORMIN, GABAPENTIN, LOSARTAN, CLOPIDOGREL, PANTOPRAZOLE, RISPERIDONE, DAILYVIT WOMEN 50+, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N) and INSULIN ASPART for an unknown indication. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (possibility of having a stroke) (seriousness criterion hospitalization), NEUROLOGICAL SYMPTOM (severe neurological symptoms) (seriousness criterion hospitalization), SPEECH DISORDER (difficulty with her speech (can think of the word, but could not get it out)) (seriousness criterion hospitalization) and GAIT DISTURBANCE (she had gait problems) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose ). The patient was hospitalized on 21-Feb-2021 due to CEREBROVASCULAR ACCIDENT, GAIT DISTURBANCE, NEUROLOGICAL SYMPTOM and SPEECH DISORDER. On 10-Mar-2021, CEREBROVASCULAR ACCIDENT (possibility of having a stroke), NEUROLOGICAL SYMPTOM (severe neurological symptoms), SPEECH DISORDER (difficulty with her speech (can think of the word, but could not get it out)) and GAIT DISTURBANCE (she had gait problems) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose ) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Company comment:Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Further information has been requested.
75 2021-04-27 fibrin d dimer increased, pulmonary embolism Approximately 2 1/2 weeks after the vaccination, the patient became short of breath. Was evaluated a... Read more
Approximately 2 1/2 weeks after the vaccination, the patient became short of breath. Was evaluated at hospital ER and found to have suffered bilateral pulmonary emboli.
75 2021-04-28 cerebrovascular accident Weakness on left side arm and leg. Stroke happened on 4/8/21.
75 2021-04-28 chest pain Patient was exposed to COVID positive person on 4/14/21 and requested test for screening. Reported n... Read more
Patient was exposed to COVID positive person on 4/14/21 and requested test for screening. Reported no symptoms at that time, but was positive. Presented to emergency department on 4/25/21 with complaints of sudden onset difficulty breathing and chest pain. She was found to be in COPD exacerbation possibly caused by COVID-19 infection or allergies. She was admitted to hospital for further management until 4/26/21.
75 2021-04-30 heart rate increased, cerebral haemorrhage, blood pressure fluctuation Redness at the area of the injection, the size of an egg; COVID arm; Dizzy spell; Fall; Brain bleed;... Read more
Redness at the area of the injection, the size of an egg; COVID arm; Dizzy spell; Fall; Brain bleed; Intermittent episodes of high blood pressure; Intermittent episodes of rapid heartbeat; Difficulty sleeping; Headaches; soreness at the site of the injection; Flushing in her face; Humming in the ears; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMORRHAGE (Brain bleed) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced FLUSHING (Flushing in her face). 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the site of the injection). On 27-Jan-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Intermittent episodes of high blood pressure), HEART RATE INCREASED (Intermittent episodes of rapid heartbeat), INSOMNIA (Difficulty sleeping) and HEADACHE (Headaches). On 29-Jan-2021, the patient experienced CEREBRAL HAEMORRHAGE (Brain bleed) (seriousness criterion medically significant), DIZZINESS (Dizzy spell) and FALL (Fall). On 02-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (COVID arm). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the area of the injection, the size of an egg). On an unknown date, the patient experienced TINNITUS (Humming in the ears). On 25-Jan-2021, FLUSHING (Flushing in her face) and VACCINATION SITE PAIN (soreness at the site of the injection) had resolved. On 10-Feb-2021, TYPE IV HYPERSENSITIVITY REACTION (COVID arm) had resolved. At the time of the report, CEREBRAL HAEMORRHAGE (Brain bleed), DIZZINESS (Dizzy spell), FALL (Fall) and VACCINATION SITE ERYTHEMA (Redness at the area of the injection, the size of an egg) outcome was unknown and BLOOD PRESSURE FLUCTUATION (Intermittent episodes of high blood pressure), HEART RATE INCREASED (Intermittent episodes of rapid heartbeat), TINNITUS (Humming in the ears), INSOMNIA (Difficulty sleeping) and HEADACHE (Headaches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Electrocardiogram: normal (normal) Normal. On 01-Feb-2021, Magnetic resonance imaging: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not reported. Treatment included steroids. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: New events of blood pressure fluctuation, heart rate increased, headache, Covid arm, tinnitus, dizziness, fall, insomnia, and cerebral haemorrhage (serious) added; case upgraded to serious; Labs coded; treatment information added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
75 2021-04-30 fainting Started feeling unwell about 10 pm on day of injection. Next morning (4/27) still not well. so far... Read more
Started feeling unwell about 10 pm on day of injection. Next morning (4/27) still not well. so far, same reaction as first dose shot. Got out of bed 2:00pm, feeling a bit better. after about 2-3 minutes started feeling worse. Took about 9-10 steps towards bedroom. I fainted and broke my left wrist. It has been set and casted, but may need surgery. I have had hundreds, maybe thousands of shots in my almost 76 years and DO NOT have any anxiety around this issue. I have NEVER before in my life fainted. This was absolutely a reaction to the vaccine! If surgery is needed - unknown length of hospitalization or permanent damage or long term disability at this time.
75 2021-05-01 fainting SEVERE DIZZINESS, NAUSCIA AND FAINTED AT 5:30AM. FELL INTO BATHROOM SINK CABINET HITTING MY HEAD... Read more
SEVERE DIZZINESS, NAUSCIA AND FAINTED AT 5:30AM. FELL INTO BATHROOM SINK CABINET HITTING MY HEAD VERY HARD. HUSBAND FOUND ME COMPLETELY KNOCKED OUT COLD. 911 CALLED AND I WAS TRANSPORTED TO HOSPITAL FOR CT SCAN OF HEAD/NECK AND OTHER TESTS. THEN 1-WEEK LATER, I DEVELOPED UNUSUAL RASH SPOTS ON MY NECK, CHEST UPPER/LOWER BACK, ON LOWER HALF OF LEGS. RASH SPOTS VERY ITCHY AND SORE ENTIRE MONTH OF APRIL 2021. URGENT DR. APPT. WITH DR. ON APR. 30. UNDETERMINED DIAGNOSIS HOWEVER POTENTIALLY ADVERSE EFFECTS FROM 2ND DOSE MODERNA VACCINE. 4/30/2021 DR. PRESCRIBED PREDNISONE 10MG TABS TWICE PER DAY FOR 5 DAYS.
75 2021-05-02 coughing up blood, nosebleed Nose Bleed for 5 & 1/2 hours on 04/25/2021 Coughing Large chunks of Dark Blood 04/25/2021 Black Stoo... Read more
Nose Bleed for 5 & 1/2 hours on 04/25/2021 Coughing Large chunks of Dark Blood 04/25/2021 Black Stool on 04/26/2021 - patient is better and improving Severe Fatigue Rash on Chest, Arms and Thighs, Upper Chest, Under Bilateral Breasts
75 2021-05-03 chest discomfort Pt had an appointment with her cardiologist 4/15/2021 and no changes in patient's health noted state... Read more
Pt had an appointment with her cardiologist 4/15/2021 and no changes in patient's health noted states daughter. Patient performed yard work at noon 4/16/2021 and developed chest tightness that was relieved by rest. After patient's nap at noon no more chest discomfort occurred. Patient went to bed that night and husband noted she was sleeping comfortbly with no breathing difficulties at midnight. At 3 am husband found patient cold and she had expired.
75 2021-05-03 pulmonary embolism Patient developed a "knot" on her left arm 3 days post vaccination. One week post vaccination the pa... Read more
Patient developed a "knot" on her left arm 3 days post vaccination. One week post vaccination the patient developed a pulmonary embolism.
75 2021-05-03 blood clot The blood vessels to the pt's spleen burst due to a clot causing removal of her spleen. During surge... Read more
The blood vessels to the pt's spleen burst due to a clot causing removal of her spleen. During surgery she was given 2 units of blood. Due to blood clots (albeit in other parts of the body) with other vaccines, the lack of splenic trauma preceeding this event, the pt's lack of history re: blood clots, and in the interest of furthering this emerging COVID-19 vaccine technology/progress, the pt's PCP and this POA thought it worth noting.
75 2021-05-04 cerebrovascular accident I had a stroke (cerebral hemorrhage) in the week following my second dose of the Moderna COVID-19 va... Read more
I had a stroke (cerebral hemorrhage) in the week following my second dose of the Moderna COVID-19 vaccine.
75 2021-05-06 nosebleed The next day she began complaining of a headache, nosebleed, fever, and body aches. The symptoms per... Read more
The next day she began complaining of a headache, nosebleed, fever, and body aches. The symptoms persisted for five days. She has since fully recovered however she did refuse the second dose of the vaccine.
75 2021-05-07 low platelet count This 75 year old white female received the Moderna Covid shot on03/03/21 and went to the ED on ... Read more
This 75 year old white female received the Moderna Covid shot on03/03/21 and went to the ED on 3/10/21 and was admitted on 3/12/21 with the following diagnoses listed below. Thrombocytopenia, unspecified
75 2021-05-11 pulmonary embolism Kit on left arm 3 days (2/19/2021) after receiving vaccine. On 2/26/2021 diagnosed with Pulmonary E... Read more
Kit on left arm 3 days (2/19/2021) after receiving vaccine. On 2/26/2021 diagnosed with Pulmonary Embolism.
75 2021-05-13 anaemia Immediately following Vaccine, I suffered with foot pain, anemia, Vertigo, nausea, low energy
75 2021-05-17 palpitations, palpitations 2nd day arm with fever, red swollen rash for shoulder to elbow; 2nd day extreme fatigue, lethargic,... Read more
2nd day arm with fever, red swollen rash for shoulder to elbow; 2nd day extreme fatigue, lethargic, light headed, confusion, loss of appetite heart racing and then seemed to skip beats. Saw doctor on March 3. symptoms continued 2 month, then began to lesson. To date only occasional heart palpatations. Some tiredness.
75 2021-05-18 blood glucose increased Visual disturbance beginning about 2 weeks after the second Moderna vaccination. Saw her primary oph... Read more
Visual disturbance beginning about 2 weeks after the second Moderna vaccination. Saw her primary ophthalmologist who did laser treatment to open the posterior capsules. This did not improve her vision so she was referred to a retinal doctor, Dr, who did wide angle fluorescein angiography and found widespread retinal vascular occlusions without hemorrhage. 90% infarcted in right eye, 80% infarcted in left eye. Corrected vision is 20/20 in each eye. There are peripheral visual field defects, but visual field not done. Features not consistent with diabetic retinopathy. Findings confirmed by reporting physician, who feels they resemble Susac syndrome and other cases of post vaccine retinal vascular occlusion of which she is aware.
75 2021-05-20 chest discomfort Patient describes feeling pressure in her chest
75 2021-05-23 cerebrovascular accident CVA
75 2021-05-24 chest pain chills, muscle aches, runny nose, shortness of breath, difficulty breathing, chest pain, nausea, hea... Read more
chills, muscle aches, runny nose, shortness of breath, difficulty breathing, chest pain, nausea, headache, fatigue, abdominal pain, diarrhea, new olfactory or taste disorder
75 2021-05-27 chest pain Some inflammation in the lungs; Severe shortness of breath/trouble breathing; Pain in the chest; Cou... Read more
Some inflammation in the lungs; Severe shortness of breath/trouble breathing; Pain in the chest; Cough; Excessive tiredness; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PNEUMONITIS (Some inflammation in the lungs), DYSPNOEA (Severe shortness of breath/trouble breathing), CHEST PAIN (Pain in the chest), COUGH (Cough) and FATIGUE (Excessive tiredness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016M21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PNEUMONITIS (Some inflammation in the lungs) (seriousness criterion hospitalization), DYSPNOEA (Severe shortness of breath/trouble breathing) (seriousness criterion hospitalization), CHEST PAIN (Pain in the chest) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization) and FATIGUE (Excessive tiredness) (seriousness criterion hospitalization). At the time of the report, PNEUMONITIS (Some inflammation in the lungs), DYSPNOEA (Severe shortness of breath/trouble breathing), CHEST PAIN (Pain in the chest), COUGH (Cough) and FATIGUE (Excessive tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Oxygen saturation: low Low. On an unknown date, SARS-CoV-2 test: negative (Negative) Tested twice and both tests came negative.. Concomitant medication were not provided. Treatment included Hospitalization in ER for 2 days Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-137829 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
75 2021-05-27 heart rate decreased, palpitations My mom never told me she got both vaccines. We all came for a funeral 2 weeks after she got her seco... Read more
My mom never told me she got both vaccines. We all came for a funeral 2 weeks after she got her second dose. She is normally active and energetic but she was very lethargic and tired. Her heart was racing and her pulse was low. She literally started contemplating death and planning her funeral. She said this was the worse she had felt in years! Possibly ever! She didn't though thank God. It took her a couple months and heavy supplements to get back close to normal.
75 2021-05-29 brain sinus blood clot Development of unexplained Cerebral venous sinus thrombosis
75 2021-06-01 chest discomfort felt like they were asphyxiating; chest felt tired; tired; body aches; was wanting to vomit, nausea;... Read more
felt like they were asphyxiating; chest felt tired; tired; body aches; was wanting to vomit, nausea; pain in the pit of stomach; nose swollen, got big; dizziness; nose hurt; nose like a tomato; felt decayed, body feels watery like is loosening; This spontaneous case was reported by a consumer and describes the occurrence of ASPHYXIA (felt like they were asphyxiating) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Rheumatoid arthritis, Gastritis, Blood pressure high and Rhinitis. Concomitant products included THIAMINE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), OMEPRAZOLE, LORATADINE and VITAMIN D3 for an unknown indication. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced ABDOMINAL PAIN UPPER (pain in the pit of stomach), NASAL OEDEMA (nose swollen, got big), DIZZINESS (dizziness), NASAL DISCOMFORT (nose hurt), ERYTHEMA (nose like a tomato), FEELING ABNORMAL (felt decayed, body feels watery like is loosening), MYALGIA (body aches) and NAUSEA (was wanting to vomit, nausea). On 19-May-2021, the patient experienced ASPHYXIA (felt like they were asphyxiating) (seriousness criterion medically significant), CHEST DISCOMFORT (chest felt tired) and FATIGUE (tired). At the time of the report, ASPHYXIA (felt like they were asphyxiating), CHEST DISCOMFORT (chest felt tired), ABDOMINAL PAIN UPPER (pain in the pit of stomach), NASAL OEDEMA (nose swollen, got big), DIZZINESS (dizziness), NASAL DISCOMFORT (nose hurt), ERYTHEMA (nose like a tomato), FEELING ABNORMAL (felt decayed, body feels watery like is loosening), FATIGUE (tired), MYALGIA (body aches) and NAUSEA (was wanting to vomit, nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Additional concomitant product: Unspecified cholesterol medication, high blood pressure medication and natural herbs. Treatment information not provided. Based on the current available information and temporal association between the use of the product and the start date of the events Abdominal pain upper, Nasal oedema, Dizziness, Nasal discomfort, Erythema, Feeling abnormal, Myalgia, and Nausea, a causal relationship cannot be excluded. Concerning the events Asphyxia, Chest discomfort, and Fatigue, very limited information regarding these events has been provided at this time. However, the patient's injection of thymine prior to experiencing Asphyxia, Chest discomfort, and Fatigue remains as a confounder. Further information can't be requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events Abdominal pain upper, Nasal oedema, Dizziness, Nasal discomfort, Erythema, Feeling abnormal, Myalgia, and Nausea, a causal relationship cannot be excluded. Concerning the events Asphyxia, Chest discomfort, and Fatigue, very limited information regarding these events has been provided at this time. However, the patient's injection of thymine prior to experiencing Asphyxia, Chest discomfort, and Fatigue remains as a confounder. Further information can't be requested.
75 2021-06-01 haemoglobin decreased, anaemia, ejection fraction decreased, hypotension, fluid around the heart, increased heart rate, fast heart rate Pt presented to acute care on 5/21/21 following 2 weeks of SOB, intermittent low grade fever and fat... Read more
Pt presented to acute care on 5/21/21 following 2 weeks of SOB, intermittent low grade fever and fatigue. Labs and chest XR ordered. Diagnosed with UTI and placed on Omnicef 300 mg BID x 7 days. Follow up in clinic on 5/24/21 for continuation of symptoms: SOB, intermittent low grade fever/chills, dry cough. Pt prescribed albuterol and labs ordered. Follow up in clinic on 5/26/21 for ongoing SOB, intermittent low grade fever, dry cough, anemia, abnormal liver function. Ordered ECG 12 lead and sent to emergency department. Admitted to hospital 5/26/21 : During hospitalization patient was diuresed with Bumex, she put out a net of approximately 2.4 L and then developed an AKI suggestive of intravascular depletion. Diuretics were stopped, confirmed that BNP down trended and was within normal range. Patient had negative troponins throughout hospitalization. Her free T4 and TSH was within normal limits. She had mild electrolyte disturbances secondary to diuretics which were replaced. She had a respiratory viral panel completed, did not identify any source. Patient is Covid negative. ANA and ANCA screen were sent out unfortunately they will be delayed. #SVT: Patient went into an SVT rate of 150 required adenosine which showed underlying sinus rhythm. Started on amiodarone drip briefly which did help maintain sinus rhythm although she had hypotension with that. Cardiology was consulted during hospitalization. Despite SVT troponins remain negative. TSH and free T4 within normal limits. #Acute on chronic combined systolic and diastolic heart failure #Suspected viral cardiomyopathy #Acute respiratory failure with hypoxia Patient remains with good saturation off oxygen. She is net -2.0 L from diuresis. Weight is down approximately 4.4 kg. Started on metoprolol, unfortunately due to hypotension had to decrease the dose to 25 mg daily. Aspirin 81 mg daily was provided. Currently holding diuretics but may need to be reassessed for restarting this in the future. ANA and ANCA pending. #Leukocytosis #Increase inflammatory markers #Sepsis with organ dysfunction No clear-cut source of infection but she did have pyuria with leukocyte esterase. She could also have had atypical pneumonia. The concern is that patient could have an underlying inflammatory process versus autoimmune process contributing to it end organ damage. At this point I cannot tell so started empiric treatment with ceftriaxone during hospitalization, complete 5 of 7 days course as well as 3 of 3 days of azithromycin. Despite this leukocyte continues to be elevated and inflammatory markers continue to be elevated. #Hypertension: Patient was briefly hypotensive in setting of amiodarone, metoprolol continue to 25 mg after discontinuation of amiodarone. Will need to be retitrate to goal-directed therapy. #Hypothyroid: TSH and free T4 within normal limits given the tachycardia holding levothyroxine for 5 days #Suspected UTI Day 5 of 7 of ceftriaxone currently, initially had 50?100 WBCs positive for pyuria, leukocyte esterase positive no bacteria seen. #Atypical pneumonia suspected: Completed 3 days of azithromycin #Elevated LFTs #Elevated alk phos: Unclear as to potential source other than congestive hepatopathy LFTs normalized alk phos downtrending #Anemia of chronic disease: Possible viral syndrome unclear etiology at this point. There may be some underlying iron deficiency. No indication for transfusion during this hospitalization. Patient remained on sodium restricted 2 g daily, and 2 L of fluid restriction diet. She is a full code and enoxaparin was used for DVT prophylaxis. Hospital transfer today, 6/2/2021 to St. Michaels with no clear unifying diagnosis. Maybe a pericarditis: Patient continues to have ST changes on EKG, elevated inflammatory markers, significant JVD, evidence of heart failure on echocardiogram, after speaking with cardiology will likely need a right heart cath
75 2021-06-02 cerebrovascular accident CVA with left hemiplegia
75 2021-06-03 heart attack Massive heart attack. Unusual and aggressive clot formation. Stent was place and almost immediately ... Read more
Massive heart attack. Unusual and aggressive clot formation. Stent was place and almost immediately clotted again despite heparin infusions.
75 2021-06-07 hypertension Begin having high blood pressure a week after final dose of vaccination. Never had high blood pressu... Read more
Begin having high blood pressure a week after final dose of vaccination. Never had high blood pressure previously.
75 2021-06-08 cardiac arrest patient died of cardiac arrest that night in hospital
75 2021-06-12 palpitations, pulmonary embolism Shortness of breath and heart palpitations. Diagnosed with pulmonary embolism.
75 2021-06-13 arrhythmia My second dose (1st was 1/21/21). was 2/25/21 No reaction except locally and fatigue. Arrhythmia ... Read more
My second dose (1st was 1/21/21). was 2/25/21 No reaction except locally and fatigue. Arrhythmia diagnosed by pulmonologist 4/2 taking my hands and then confirmed by 2 EKGs. Never had any kind of heart issue. AM asymptomatic except perhaps shortness of breath. Currently wearing monitor and had echocardiogram this morning.
75 2021-06-13 chest discomfort, heart rate increased Extreme fatigue. Rapid heart beat. Ache all over. Joint pain Pressure in chest Can?t get bre... Read more
Extreme fatigue. Rapid heart beat. Ache all over. Joint pain Pressure in chest Can?t get breathe
75 2021-06-13 low platelet count Patient did not have vaccine card with her today, so Lot number was unavailable Sepsis- developed o... Read more
Patient did not have vaccine card with her today, so Lot number was unavailable Sepsis- developed on day 1 post-2nd-vaccine Thrombocytopenia B-cell lymphoma Henoch-Schoenlein purpura/IgA vasculitis
75 2021-06-15 hypertension, cerebrovascular accident high blood pressure, I was having continual headaches , loss of smell and taste and hair loss, I di... Read more
high blood pressure, I was having continual headaches , loss of smell and taste and hair loss, I did not lose my sense of smell and taste when I had COVID-19 in November 15th, 2020. I never had high blood pressure prior to the vaccination. I am on high blood pressure medication after the vaccine. I was on BP medication when I took the second dose and my BP still went real high. I still have loss of taste and smell , and I still have high blood pressure, and I'm still continuing with the headaches.
75 2021-06-28 heart rate increased She started having rapid heartbeat. It increased gradually and lasted about an hour or so, Did not g... Read more
She started having rapid heartbeat. It increased gradually and lasted about an hour or so, Did not get treatment. But now wears a heart monitor (Zio), for the next two weeks, because of the heart beat issues coming and going. And she did call 911. The fire dept. came first and told her she was ok, and gave her calming techniques.
75 2021-06-29 chest pain, palpitations extremely sore and red itchy arm, high fever (normal 97.4 had 102.2) for 2 days, fatigue for a week,... Read more
extremely sore and red itchy arm, high fever (normal 97.4 had 102.2) for 2 days, fatigue for a week, heart palpitations on and off for 3 weeks and then wound up in emergency room and to hospital by ambulance for overnight (chest pains) which after they did lung, abdomen scans and eco cardiogram and ekg was diagnosed as inflammation of chest cavity
75 2021-07-05 blood clot Diagnosed with a blot clot in the left leg lower below knee.; This spontaneous case was reported by ... Read more
Diagnosed with a blot clot in the left leg lower below knee.; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Diagnosed with a blot clot in the left leg lower below knee.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008c21a) for COVID-19 vaccination. Concomitant products included HYDROCODONE for an unknown indication. On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced THROMBOSIS (Diagnosed with a blot clot in the left leg lower below knee.) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Diagnosed with a blot clot in the left leg lower below knee.) outcome was unknown. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
75 2021-07-06 blood pressure increased Broke out with blisters on left leg and heal which scabbed and seeped. major area around blisters s... Read more
Broke out with blisters on left leg and heal which scabbed and seeped. major area around blisters sorrounded by large rash. Also broke out on leg and thigh on left and right leg. On the first day of breakout my blood presure (taken at home) was 180/90. It in the 140's for the next three weeks. During third week of issue had a very hard time with emotions; anxiety, could cry at any time, thoughts of death, not suicide but what it was like to die. Never in my 75 years of life have I experienced anything like this. I am energetic and very positive. Emotional issue lasted 1 week. Entire reaction lasted 4 weeks. I was seen by a walk in clinic and was diagnosed with poison ivy in the beginning. I sought a second opinion from my family physician who agreed. I disagreed with both as I had not been any where near plant life. I then saw my cardiologist who felt there was a possible reaction to a new BP med he had put me on a month before. At this time I thought it might have been a reaction to the moderna 2nd shot, but did not pursue this until I recently have become aware of possible reactions with blisters and emotions. I do have pictures of the reaction
75 2021-07-06 heart rate irregular, lightheadedness I woke up with a severe sore throat/neck, 2 days after the shot. This severe pain began to the left ... Read more
I woke up with a severe sore throat/neck, 2 days after the shot. This severe pain began to the left side of my throat, in the thyroid area and lasted for about a month. The severe pain moved to my right thyroid for another 2 months. It was painful to eat and to talk. I also had irregular heart beats, that were not flutters, but wild flip flops about a month and half later. I nearly blacked out and it felt like it had speeded up. I called my clinic and the triage nurse said if I ever had the same reaction, to get to the ER. Idid, the next day I had another episode. I went to the hospital.
75 2021-07-09 deep vein blood clot blood clot --dvt---found on april 28 2021-------throbbing in leg....placed on Eliquis 5mg. as of j... Read more
blood clot --dvt---found on april 28 2021-------throbbing in leg....placed on Eliquis 5mg. as of july 10 2021 still taking eliguis ....follow up with doctor on july 21 2021
75 2021-07-10 blood clot Blood clot on leg; lump on leg; Very painful lump; This spontaneous case was reported by a consumer ... Read more
Blood clot on leg; lump on leg; Very painful lump; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clot on leg) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot on leg) (seriousness criterion medically significant), LIMB MASS (lump on leg) and PAIN IN EXTREMITY (Very painful lump). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clot on leg), LIMB MASS (lump on leg) and PAIN IN EXTREMITY (Very painful lump) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) a clot in her leg. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Patient was currently on a blood thinner medication. This case concerns a 75-year-old female with a serious unexpected event of thrombosis, and nonserious limb mass and pain in extremity. Event onset with unknown latency after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up information received on 01-JUL-2021: Email address of primary reporter added, additional reporter added, vaccination facility updated. On 06-Jul-2021: Significant follow-up received - Case upgraded to serious; Sender's Comments: This case concerns a 75-year-old female with a serious unexpected event of thrombosis, and nonserious limb mass and pain in extremity. Event onset with unknown latency after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
75 2021-07-12 heart flutter, arrhythmia experiencing extra beat, high rate of beats per second; had a fierce itch for 2 weeks; flutters; hav... Read more
experiencing extra beat, high rate of beats per second; had a fierce itch for 2 weeks; flutters; having cramps like a Charlie horse in her legs more than normal; harder for her to breath; arms hurt/feet are beginning to hurt; pain is becoming more pronounced, is constant, hurts too bad to exercise, hurts so bad she doesn't want to get out of bed/has a pacemanker/defibrillator and surrounding tissue is sore; not resting well at night because of the pain; hips hurt, shoulders hurt, joint pain; thigh muscles hurt, every muscle hurts; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (experiencing extra beat, high rate of beats per second) and CARDIAC FLUTTER (flutters) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020b21a and 014m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19, Pacemaker insertion (cardiac) and Implantable defibrillator insertion. Concurrent medical conditions included COPD, Asthma and Thrombosis arm (blood clot in her left arm). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), UMECLIDINIUM BROMIDE (INCRUSE), SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), APIXABAN (ELIQUIS) and LEVOTHYROXINE for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced MYALGIA (thigh muscles hurt, every muscle hurts). On 09-Apr-2021, the patient experienced MUSCLE SPASMS (having cramps like a Charlie horse in her legs more than normal), DYSPNOEA (harder for her to breath), PAIN IN EXTREMITY (arms hurt/feet are beginning to hurt), PAIN (pain is becoming more pronounced, is constant, hurts too bad to exercise, hurts so bad she doesn't want to get out of bed/has a pacemanker/defibrillator and surrounding tissue is sore) and POOR QUALITY SLEEP (not resting well at night because of the pain). 09-Apr-2021, the patient experienced ARTHRALGIA (hips hurt, shoulders hurt, joint pain). On 30-Jun-2021, the patient experienced CARDIAC FLUTTER (flutters) (seriousness criterion medically significant). On an unknown date, the patient experienced ARRHYTHMIA (experiencing extra beat, high rate of beats per second) (seriousness criterion medically significant) and PRURITUS (had a fierce itch for 2 weeks). The patient was treated with HYDROCODONE for Adverse event, at a dose of 1 dosage form. At the time of the report, ARRHYTHMIA (experiencing extra beat, high rate of beats per second) and CARDIAC FLUTTER (flutters) outcome was unknown and MUSCLE SPASMS (having cramps like a Charlie horse in her legs more than normal), DYSPNOEA (harder for her to breath), PAIN IN EXTREMITY (arms hurt/feet are beginning to hurt), PAIN (pain is becoming more pronounced, is constant, hurts too bad to exercise, hurts so bad she doesn't want to get out of bed/has a pacemanker/defibrillator and surrounding tissue is sore), POOR QUALITY SLEEP (not resting well at night because of the pain), PRURITUS (had a fierce itch for 2 weeks), MYALGIA (thigh muscles hurt, every muscle hurts) and ARTHRALGIA (hips hurt, shoulders hurt, joint pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal and clear. Patient reported that within one week she started hurting.She stated every muscle hurts.Her hips, arms, shoulders hurt and now her feet are beginning to hurt.She stated her thigh muscles hurt.She says it was both joint and muscle pain.She was not resting well at night because of the pain. Pain was becoming more pronounced and was constant.She also reported having cramps like a Charlie horse in her legs more than normal.She states it hurts too bad to exercise and some days it hurts so bad she doesn't want to get out of bed.She also reported that it was harder for her to breath since she got the vaccine.Her doctors have run a battery of tests and cannot find anything.She reported her autoimmune test was normal.Doctors have told the patient that everything was fine.She had a pacemaker/defibrillator and stated the surrounding tissue was sore.She had a history of a blood clot in her left arm since the pacemaker/defibrillator implantation, so she doesn't use that arm for medical procedures.She forgot to mention that she had a fierce itch for 2 weeks and the doctors told her she can use antiitch cream.She also reports she took a THC/CBD gummy which worsen her pain.She took a Hydrocodone at a different time and that made her side effects hurt even worse the next morning.She went to a cardiologist and they took a CAT scan and blood work (which came out normal and clear).She also reported that getting out of bed today was a killer.She visited her cardiologist on 30-jun-2021, since then she was experiencing extra beat.She never experienced this before, high rate beat per second.She had a pacemaker.Patient stated that this symptom started immediately after the second dose.She had a follow-up with her cardiologist reading her pacemaker.She claims that she was told that she had flutters this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-211592, MOD-2021-211687 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Additional information received on 07-Jun-2021 contain no new information. On 03-Jul-2021: Additional information received on 03-Jul-2021:Additional event of fierce itch was added, laboratory data was added, treatment information was updated and event outcome was updated. On 08-Jul-2021: Additional information received on 08-Jul-2021: Additional event flutters was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
75 2021-07-20 cerebrovascular accident Stroke; Neck aches; Itching at the injection site; Soreness at the injection site; Random headaches;... Read more
Stroke; Neck aches; Itching at the injection site; Soreness at the injection site; Random headaches; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced NECK PAIN (Neck aches), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and HEADACHE (Random headaches). On 18-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), NECK PAIN (Neck aches), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and HEADACHE (Random headaches) outcome was unknown. Concomitant medications were not provided. Treatment information was not reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up received on 19-JUL-2021 updated new event-Stroke and outcome of the event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
75 2021-07-26 oxygen saturation decreased, hypotension Low blood pressure, low oxygen, body aches, shortness of breath.
75 2021-07-27 blood clot, excessive bleeding Aortic Dissection hemostatic shock; Anaphylactic shock; Paralyze in the lower half of her body; Clo... Read more
Aortic Dissection hemostatic shock; Anaphylactic shock; Paralyze in the lower half of her body; Clotting; Excessive bleeding; Burning sensation going down to her spine; Difficulty breathing; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock), PARALYSIS (Paralyze in the lower half of her body), THROMBOSIS (Clotting), HAEMORRHAGE (Excessive bleeding), BURNING SENSATION (Burning sensation going down to her spine), DYSPNOEA (Difficulty breathing) and AORTIC DISSECTION (Aortic Dissection hemostatic shock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054c21a and 009c21a) for COVID-19 vaccination. The patient's past medical history included Open heart surgery on 18-May-2021. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criteria death, hospitalization and medically significant), PARALYSIS (Paralyze in the lower half of her body) (seriousness criteria death, hospitalization and medically significant), THROMBOSIS (Clotting) (seriousness criteria death, hospitalization and medically significant), HAEMORRHAGE (Excessive bleeding) (seriousness criteria death, hospitalization and medically significant), BURNING SENSATION (Burning sensation going down to her spine) (seriousness criteria death and hospitalization) and DYSPNOEA (Difficulty breathing) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced AORTIC DISSECTION (Aortic Dissection hemostatic shock) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 22-Jun-2021 to 04-Jul-2021 due to ANAPHYLACTIC SHOCK, BURNING SENSATION, DYSPNOEA, HAEMORRHAGE, PARALYSIS and THROMBOSIS. The patient died on 04-Jul-2021. The reported cause of death was aortic dissection hemostatic shock. An autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2021, Blood pressure measurement: decreased (abnormal) Systolic blood pressure <90 mmHg. On 22-Jun-2021, Heart rate: increased (abnormal) Heart rate >100 beats per min. No relevant concomitant medications were reported. Oxygen was given as treatment. She had the second dose on 22JUN2021. 5 hours after the vaccine, she had a burning sensation going down to her spine. Then she was paralyzed in the lower half of her body. She was rush to the local hospital. She was medevac to another hospital. She had clotting and excessive bleeding. She was in the hospital for 13 days. She passed on 04JUL2021 Company comment: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received- Patient demographics, cause of death, lab data, causality and vaccination details updated.; Sender's Comments: This is a case of sudden death in a 75-year-old male subject with hx of open heart surgery, who died 12 days after receiving second dose of vaccine. Very limited information has been provided at this time. However, recent open heart surgery might have at least partially contributed to the events occurrence.; Reported Cause(s) of Death: Aortic Dissection hemostatic shock