Moderna

Psychological symptom reports

Female, 60 - 75 years

Age Reported Symptoms Notes
60 2020-12-31 feeling abnormal 101 fever, severe chills, nausea and vomiting, splitting headache and feeling of all nerve endings b... Read more
101 fever, severe chills, nausea and vomiting, splitting headache and feeling of all nerve endings being inflamed. Hands initially purple than swollen. Severely ill for about 16 hours but took another 24 for full recovery.
60 2021-01-03 disturbance in attention 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 anxiety 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 2021-01-05 impaired work ability Monday, January 4 in the evening I became very fatigued, to the point where I couldn't stay awake. ... Read more
Monday, January 4 in the evening I became very fatigued, to the point where I couldn't stay awake. When I woke up a few hours later, I noticed that I had a very bad headache and all-over body aches, and I felt like I had the flu. Weak, nauseous and extremely tired. I went to bed and slept through the night, when my alarm woke me at 7:00 am on Tuesday, January 5, I got up to use the bathroom and felt all the same symptoms from the night before, only worse. I noticed that I had a rash on my left arm below the injection site. I called in sick and went back to bed. I slept from approximately 7:30 to 2:00 pm on January 5. I felt a little better upon awakening, but had a very bad headache and no appetite. The other body aches seemed better.
60 2021-01-05 sleep disorder Severe arm pain at the site of the injection which started 24 hours after injection and persisting ... Read more
Severe arm pain at the site of the injection which started 24 hours after injection and persisting through today - day 9 postvaccine. The pain is lateral upper right arm and descends inferiorly toward the elbow. No redness or swelling at the site. I'm having great difficulty with sleep because of the pain. The pain is aggravated by motion. The pain is helped somewhat with ibuprofen 200 mg every 6-8 hours.
60 2021-01-06 anxiety Vaccine on December 30th @ 8:30 am. Fine all day until 1:00am next morning 12/31 it woke me up with ... Read more
Vaccine on December 30th @ 8:30 am. Fine all day until 1:00am next morning 12/31 it woke me up with fever, bad body aches hurt to touch me, left arm I couldn't move painful, nausea and bad headache this went on for 2 days(12/31 & 01/01). Next 2 days (1/02 & 1/03) was recovering with just soreness, anxiety and headache(Migraine Med help), tired and shortness of breath9inhaler0. Was like having Covied again.
60 2021-01-06 irritability 2 hours after my vaccine. My right side of my neck became stiff from the back of my head all the wa... Read more
2 hours after my vaccine. My right side of my neck became stiff from the back of my head all the way to right shoulder. Lasted for 24 hours. Then I slept for 17 hours straight and had malaise and fatigue for 6 days after that. I am still with low energy level and my mood I'd irritatabl. Now with a small amount of swelling on left side of lip which is not getting bigger but lip feels thick. Bilateral cheeks slight swollen.
60 2021-01-06 restlessness restlessness throughout body same night, next morning woke up with body aches, nausea, pain in joint... Read more
restlessness throughout body same night, next morning woke up with body aches, nausea, pain in joint/muscles, shaking , headache, fever 100. Took Tylenol arthritis
60 2021-01-06 sleep disorder "very sore arm for 2 days, difficulty lifting arm, pain woke me in the night. Also developed fever ... Read more
"very sore arm for 2 days, difficulty lifting arm, pain woke me in the night. Also developed fever and nausea which only lasted about 6 hours"
60 2021-01-07 feeling abnormal Headache, Myalgia, NauseaVomiting, Mental fogginess Narrative: Pt reported headache x 3 days. She ha... Read more
Headache, Myalgia, NauseaVomiting, Mental fogginess Narrative: Pt reported headache x 3 days. She has fully recovered.
60 2021-01-07 impaired work ability shaking chills, fever, myalgias, fatigue increasing over course of 8-24 hours after injection; sever... Read more
shaking chills, fever, myalgias, fatigue increasing over course of 8-24 hours after injection; severe enough that could not work
60 2021-01-07 insomnia Tire on day one-slept for 18 hours. Day 2: Woke up and was mildly achy, not wanting to do anything... Read more
Tire on day one-slept for 18 hours. Day 2: Woke up and was mildly achy, not wanting to do anything and red large swelling in my right deltoid. Very tender. Also, edema starting in my right axilla extending down my lateral chest about 7". Day 3 to 7: Achiness is gone. Edema and swelling continue. Eventually the red swollen area became itchy. The edema under my arm (not a lymph node) was tender when my arm was close to my body. Woke me up during the night frequently. Very hard to sleep.
60 2021-01-07 memory impairment Migraine numbness of lips tingling in right foot and right leg Chills sweating memory issues hard t... Read more
Migraine numbness of lips tingling in right foot and right leg Chills sweating memory issues hard to think of words granddaughter sad she thought I slurred some words
60 2021-01-08 feeling abnormal Close to 1100 she began to complain of not feeling well, primarily complained of feeling dizzy, feel... Read more
Close to 1100 she began to complain of not feeling well, primarily complained of feeling dizzy, feeling a little weird but felt it would pass. Around 1115 she was still dizzy, stated she didn?t have much to drink or eat, so we brought her water and a snack. No hx of diabetes. 1120 she looked flushed, and now had tingling in her left arm. Took her BP 140/70, HR 70, temp on her forehead 97.1. 1130 she continued to have a strange feeling in her arm from her shot site to her left hand, and up her neck. Vaccinator counseled her to take an antihistamine once she gets home. Patient called her husband and her son who would take 40 minutes to come get her. She began to exercise her left arm, and began to feel better. She left with her family at approximately 1:00, still a little dizzy, no longer flushed with less discomfort. We called her at 7;15 pm and she reported that symptoms had resolved. Took Zyrtec. Extended observation and sent home.
60 2021-01-10 sleep disorder I feel issue is more related to injection error, Injection site was above the deltoid. I have had st... Read more
I feel issue is more related to injection error, Injection site was above the deltoid. I have had steroid injections in other shoulder and this is the sensation I felt during injection. The rn also told me " You have tough skin" after the intense pressure started. I worked the night before injection. I went home to sleep. woke around 2pm with intense pain in my left arm, I could not shift position or move my arm. with out excruciating pain. I used heat, aleve, tylenol & biofreeze. By saturday, i could easily move left arm from elbow down, but extremely limited from shoulder. today i have most of my range of motion, but still have dull ache and pain restrictions. This pain is in my shoulder, not my arm or deltoid. . On thursday, pain was constant, roaring throb 7/10 shoulder to shoulder blade, almost to spine in back and down to elbow , then 9/10 with any movement. Today is ache 2/10 just in my shoulder, with 5/10 with some movement. I had to call into work 1/7. I am scheduled tonight. I am an ICU RN.
60 2021-01-12 anxiety Patient calls to report headache, nausea, sharp pains in joints, left arm is swollen at injection si... Read more
Patient calls to report headache, nausea, sharp pains in joints, left arm is swollen at injection site and hurts, she was not feverish this morning, but feels feverish now (1330pm), and anxiety
60 2021-01-14 impaired work ability 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 2021-01-16 loss of personal independence in daily activities Starting on Day 9 post injection I awoke with severe flu like symptoms: severe headache, body aches... Read more
Starting on Day 9 post injection I awoke with severe flu like symptoms: severe headache, body aches, joint aches, fatigue, inability to get out of bed. Once I did get up I noted a severe red rash covering chest and extending up anterior neck (looked like a radiation burn). Symptoms lasted all day and made work or ADLs impossible. Felt about 75% better next day then symptoms returned the following day. Rash began peeling and appeared to look like a 2nd degree burn. Symptoms resolved by Day 4.
60 2021-01-18 anxiety 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 loss of personal independence in daily activities 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 2021-01-20 feeling abnormal same day, soreness in arm, dizziness and brain fog, headache. Headache continued for one week. Aft... Read more
same day, soreness in arm, dizziness and brain fog, headache. Headache continued for one week. After 7 days, injection site started itching, day 8 had a blistering rash and hard, swollen area about 2" in diameter. Felt feverish beginning on 6th day. Still have rash that is swollen and warm to the touch at day 9.
60 2021-01-21 feeling abnormal 5 hours after the shingles vaccine on 1/14/21 I could not form words and it was extremely difficult ... Read more
5 hours after the shingles vaccine on 1/14/21 I could not form words and it was extremely difficult to speak. The wrong word came out. I felt dizzy and out of it. This lasted for 2-3 hours. The next day it was much better but I still feel that problem a little bit. Secondly, I felt tingling in my head, arms and legs since then, slowly waning.
60 2021-01-24 agitation, feeling abnormal pt stated she is agitated, brain is foggy, severe bone pain, joint pain, right arm completely swolle... Read more
pt stated she is agitated, brain is foggy, severe bone pain, joint pain, right arm completely swollen (this symptom subsided after a little over a week), muscle weakness, both hands are extremely weak, has excruciating pain in left arm and limited range of motion, intensified neuropathy.
60 2021-01-24 disorientation 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 2021-01-24 sleep disorder Arm started getting sore on Saturday, by Saturday so sore could not lay on that side, Sunday woke up... Read more
Arm started getting sore on Saturday, by Saturday so sore could not lay on that side, Sunday woke up and was extremely tire, started running a low grade fever( did not have a thermometer) by Sunday night I was was running higher temp it seemed and then in the middle of the night I statrted sweating. Woke up on Monday feeling much better, still tiered than usual . How ever no temp and injection site is not as sore,
60 2021-01-25 impaired work ability 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 sleep disorder Started as L arm pain, progressed to severe headache 10/10 all evening. Could not sleep. Next day ... Read more
Started as L arm pain, progressed to severe headache 10/10 all evening. Could not sleep. Next day intense headache persisted, developed nausea and vomiting , dry heaves for 12 hours. + low grade fever. Took aleve 2 tabs - developed abdominal pain, no change in headache. Day 3 arm pain gone, headache and stomach pain intense, no appetite. Nausea persisted. Day 4 - minimal appetite, nausea, abd pain with eating. Headache . No other meds taken aside from aleve single dose. Last two days - headache present but less intense. Abdominal pain only when eating. Appetite still low.
60 2021-01-26 anxiety Whole body itching Nausea Slight swelling of airway and lower lip Feeling of anxiety Above symptoms ... Read more
Whole body itching Nausea Slight swelling of airway and lower lip Feeling of anxiety Above symptoms started w/I 20 min of injection, still itchy and taking Benadryl at 2300 Swelling at site of injection about the size of a small orange
60 2021-01-26 impaired work ability Mild headache and fatigue one hour after administration. Nausea to the point of emesis by 1630, head... Read more
Mild headache and fatigue one hour after administration. Nausea to the point of emesis by 1630, headache increased in severity and beginning to chill, visible tremoring, requiring my leave from work before the end of my shift. Sore at injection site by 2000 hrs. site had swollen to the side of a tangerine orange red, hard, tender, the previous injection site from the first vaccine approximately one inch above was also swollen, and red, but the size of a dime stacked 3x. Both injections sites had their own circular indurations, I have never had a reaction to vaccine like this. My arm ached going down to my fingers and up into my neck. My spine ached from the base of the skull to my tailbone, and my hips, but not as severe as the first vaccine reaction. I was able to move without being brought to tears. The nausea persisted. The chilling this time brought a low grade fever 99.8. Unable to work the second day after the vaccine. Symptoms persist till Saturday around 1600hrs then completely gone. Reported S/S to Dr. day of second dose of the vaccine administered. Advised to continue Tylenol .
60 2021-01-27 impaired work ability Fever; cold chills; headache; body aches; arm pain Left work early
60 2021-01-27 loss of personal independence in daily activities Two days after the vaccination you experienced body pain all over. No fever, very cold/chills in th... Read more
Two days after the vaccination you experienced body pain all over. No fever, very cold/chills in the middle of her back. Severe neck and back pain, not able to walk without pain, unable to get our of bed, was in so much pain. Pain moves around her body, not in the same place every day. Hands still swollen, unable to make a fist. Legs and feet hurting. Still unable to open a door.
60 2021-01-28 feeling abnormal Dizziness and instability
60 2021-01-28 panic attack Panic attack
60 2021-01-28 sensation of foreign body Node in back of arm; Arm still hurt; Nausea; Received a sub-cutaneous injection; Felt like she had a... Read more
Node in back of arm; Arm still hurt; Nausea; Received a sub-cutaneous injection; Felt like she had a ball in her throat; Thought she was going to pass away; Dizziness; Weakness; A spontaneous report was received from a nurse, concerning herself, a 60 year-old female patient, who received Moderna's COVID-19 vaccine and experienced dizziness, weakness, nausea, felt like she had a ball in her throat, arm still hurt, node in the back of arm and received a subcutaneous injection. No relevant medical history was provided. Concomitant medications reported included metoprolol, omeprazole, and melatonin. On 15-Jan-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 011J20A) subcutaneously in her left arm for COVID-19 infection prophylaxis. On 15-Jan-202, patient received her first dose of the vaccine at background of left arm. On the same date, after administration of vaccine, she stayed in place for 25 minutes/1hour as she experienced dizziness, weakness and nausea, she also felt like she had a ball in her throat and thought that she was going to pass away. Few minutes later, patient was feeling little better but then started again, hence stayed back for an hour in the same place. On 19-Jan-2021 (today) her arm was still hurt pretty much and had a node in her back arm. Patient also stated that vaccine was not administered in her muscle instead injection was provided sub-cutaneous. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the event, received a sub-cutaneous injection, was considered to be resolved on 15 Jan 2021.The outcome of the events dizziness, weakness, nausea, felt like she had a ball in her throat, was considered to be unknown. The outcome of the events arm still hurt, and node in the back of arm was considered to be not resolved.; Reporter's Comments: This case concerns a 60-year-old, female patient. The patient's medical history was not provided. The patient experienced a non serious event of dizziness, malaise, nausea, asthenia, lump in throat, subcutaneous injection, pain and swelling in arm. The event occurred the day the patient received the first dose of mRNA-1273 (lot number 011J20A). 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.
60 2021-01-30 sensation of foreign body FEELING OF LUMP AND TIGHTNESS OF THROAT 1007 PATIENT STATES FEELING OF LUMP IN THROAT AND MILD DISCO... Read more
FEELING OF LUMP AND TIGHTNESS OF THROAT 1007 PATIENT STATES FEELING OF LUMP IN THROAT AND MILD DISCOMFORT. DENIES SHORTNESS OF BREATH, CHEST DISCOMFORT, OR PAIN 1012 PATE STATES THIS FEELING IS BETTER AND IS DRINKING TEA 1020 PATIENT FEELING NOT GETTING ANY WORSE, DENIES ANY DIFFICULTY BREATHING OR SWALLOWING. 1030 PATIENT IS FEELING BETTER, NO PROBLEMS BREATHING OR SWALLOWING. NO HIVES OBSERVED, PATIENT SKIN IS PINK AND WARM TO TOUCH. AND SHE IS TOLERATING TEA 1042 PATIENT INSTRUCTED TO CALL EMERGENCY MEDICAL SERVICES IF ANY SHORTBESS OF BREATH OR CHEST DISCOMFORT WHILE AT HOME. PATIENT VERBALIZES UNDERSTANDING. PATIENT STATES SHE IS FEELING BETTER AND WITH TAKE HER ALLERGY MEDICATION WHEN SHE GETS HOME. PATIENT DROVE HOME
60 2021-01-31 impaired work ability 2.5 hours after the injection I developed left arm swelling, itching with ertyhemia as well as, seve... Read more
2.5 hours after the injection I developed left arm swelling, itching with ertyhemia as well as, severe headache, nausea, GI turbulence, fatigue, and chills. I had to stop working that day and the next day. The headache was unrelenting. I went to bed with a heating pad on my head. Typically my body temp is 97.3 it went up to 98.1 I took Ibuprofen and Benadryl around the clock for the next 10 days. Day 8 & 9 were the worst. My arm looked like an orange at the site of the injection; it was red/inflamed, induration & itched. The welt size 2" x 1". My headache was intractable, severe chills with teeth chattering, nausea, GI turbulence. It was a horrible 48 hours at which time I was again not able to work. I finally felt better on day 10. On day 14 my arm finally looked like it had not had an injection in it.
60 2021-01-31 impaired work ability 2.5 hours after the injection I developed left arm swelling, itching with erythemia as well as, seve... Read more
2.5 hours after the injection I developed left arm swelling, itching with erythemia as well as, severe headache, nausea, GI turbulence, fatigue, and chills. I had to stop working that day and the next day. The headache was unrelenting. I went to bed with a heating pad on my head. Typically my body temp is 97.3 it went up to 98.1 I took Ibuprofen and Benadryl around the clock for the next 10 days. Day 8 & 9 were the worst. My arm looked like an orange at the site of the injection; it was red/inflamed, induration & itched. The welt size 2" x 1". My headache was intractable, severe chills with teeth chattering, nausea, GI turbulence. It was a horrible 48 hours at which time I was again not able to work. I finally felt better on day 10. On day 14 my arm finally looked like it had not had an injection in it.
60 2021-01-31 loss of personal independence in daily activities Considered as grade 3 level headache that prevented daily activity per employee. Arm sourness at inj... Read more
Considered as grade 3 level headache that prevented daily activity per employee. Arm sourness at injection site. T102.0 1/19/21 at 1300 on 1/19/2021. fatigue, chills, myalgia. Took tylenol with no relief.
60 2021-02-01 disorientation, excessive sleepiness Flu like symptoms, fatigue (lack of energy to do daily activities), disorientation, inability to bre... Read more
Flu like symptoms, fatigue (lack of energy to do daily activities), disorientation, inability to breath, headaches, sleeping up to 15 hours a day. Lived on over the counter medicine (Musinex), nasal spray, albuterol inhaler, aspirin and alka selter. Started feeling better on February 1st. Scared to take the second round, which is due to be taken on February 16th.
60 2021-02-01 disturbance in attention I have chills, fever,muscle aches and what feels the worst is the nauseau, like I want to throw up. ... Read more
I have chills, fever,muscle aches and what feels the worst is the nauseau, like I want to throw up. It was hard to enter this online note. I just missed the phone hours. I am tired and arm hurts to raise it. I want to sleep and maybe throw-up. It is hard to complete forms and no energy to read the detailed instructions. Both shots were given at the clinic. I also have a mild right sided back painthoracic mild muscle spasm. Harder to concentrate at work.
60 2021-02-01 impaired work ability, feeling abnormal From the date of the vaccine given I only had a sore arm for a couple of days. Nothing then until d... Read more
From the date of the vaccine given I only had a sore arm for a couple of days. Nothing then until day 7 then I started to feel run down and noticed a lymph node on my left chest at the clavicle. It was large . I wasn't thinking about my vaccine at all at that time. I made an appointment with the PAC and he was concerned about it and had me do an ultrasound and blood work. The ultrasound showed nodes measuring 4-16 mm concerning for lymphoma or just reactive. Then I had a ct and the impression was indeterminate left axillary lymphadenopathy. For the next 7 days I was home in bed a lot and was not able to take call as scheduled at my work place. They hurt and I also developed a rash on the injection site, the back, the scalp and neck. It itched and was annoying. As the days progressed my nodes on my chest hurt and I could feel them as well as my groin and abdomen. January 28 my left arm started burning and hurting when I stretched it out to do activities or work. February 1 a lymph node appeared in my inner elbow space I confirmed this with my Dr. that it was a lymph node. It doesnt hurt as much now as before it swelled. Not drinking extra water on any given day makes them all hurt more. I felt rotten enough the 7-14 days after I had a covid test and it was negative. I just found out today that my Covid 2 igG Sar2 GB was positive on 1/14/21. My other lab work was perfect
60 2021-02-02 feeling abnormal I experienced fever of 102.8, chills, tremors, leg pain, body aches, dizziness, diarrhea, "foggy" br... Read more
I experienced fever of 102.8, chills, tremors, leg pain, body aches, dizziness, diarrhea, "foggy" brain
60 2021-02-02 impaired work ability I received my 2nd dose of the Moderna vaccination on1 /26/2020 @ 3:16 pm. The following day at 10 a... Read more
I received my 2nd dose of the Moderna vaccination on1 /26/2020 @ 3:16 pm. The following day at 10 am I had severe throbbing headache (forehead). I took Tylenol but was unable to work the rest of the day due to the throbbing headache. One week later- 2/1/2021 my arm at the injection site is very bruised and sore.
60 2021-02-02 sensation of foreign body Approx 38min after injection pt c/o feeling lightheaded and that her throat was dry with "a lump." ... Read more
Approx 38min after injection pt c/o feeling lightheaded and that her throat was dry with "a lump." Rec'd Benadryl 25mg PO at 0754. Vitals at 0755 160/74, 70, 98% on room air, Vitals at 0800 260/94, 74, 98% on room air. At 0801 pt c/o having slight difficulty swallowing, denies respiratory complaints. EMS called. EMS on scene at 0807. Pt talking normally with no s/s of distress. Pt transported to ED with EMS.
60 2021-02-03 feeling abnormal Chills, fatigue, headache, ?brain fog?, dizziness
60 2021-02-03 feeling abnormal About 3 PM she received her second vaccination for Covid. She states that she has a history of adve... Read more
About 3 PM she received her second vaccination for Covid. She states that she has a history of adverse reactions to flu vaccines that are anaphylactic like in the past. She usually premedicates with Benadryl and steroids. Today she did take 100 mg of Benadryl prior to her vaccination. Shortly after receiving the vaccine, she did feel like her throat was getting a little bit tight but she did not feel like it was true anaphylaxis. However she then felt very off. After this vaccine her throat started to feel tight, and she stated she did not feel well overall. She did have some tunnel vision and was shaky. At about 1730 her heart rate drops to the 30s, she started feeling itchy, and then she went into a coughing fit and started to feel her throat close. She received 0.3 mg IM epinephrine, 20 mg IV famotidine, 125 mg IV methylprednisone, 0.5 mL of nebulized racepinephrine, and 500 mL NS bolus. She has since recovered and is stable on room air.
60 2021-02-03 poor quality sleep at 11:10 PM last night 02/03 my neck was starting to itch. I was on my way home from work and at 11:... Read more
at 11:10 PM last night 02/03 my neck was starting to itch. I was on my way home from work and at 11:30 the itching was going down my chest. At 11:45. I took my shirt off and it was spreading across my chest and my breast. I called the toll free number and left a voicemail, I tried to access the website and was unable to. My son had generic Benadryl so I took 2 of those and I laid down to go to bed. I had a restless night but I didn't get out of bed until about 5:30. I went to the bathroom and looked and the rash was spreading more I was still tired so I laid back down and got up about 8:00 am and I was itching and burning from head to toe. I went to the bathroom and took off my pajamas. And I am covered with a red bumpy rash all over my body. I didn't want to take anymore of generic Benadryl because obviously it didn't work. I waited till 9 am until Dr. office opened and I called them and they told me to take over the counter Benadryl and to get Benadryl cream from over the counter. They told me they were cancelling my 2nd vaccine because they thought I was having an allergic reaction to the 1st vaccine. I asked if I could get steroids, prednisone, they said the doctor advised against it because it would suppress my immune system. And he told me if I started wheezing or any shortness of breath to go to the ER and they told me to call in if I have any more side effects. So I got dress and went to pharmacy and bought Benadryl cream and Benadryl tablets and lidocaine spray. I did take the Benadryl, sprayed the spray and rubbed the cream and it is only helping a little.
60 2021-02-04 impaired work ability 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 sleep disorder On February 03, 2021 my arm started itching. On February 04, 2021 my arm continued to itch with the... Read more
On February 03, 2021 my arm started itching. On February 04, 2021 my arm continued to itch with the appearance of three distinct circular areas of bumps (dime sized circles). On February 05, 2021 I was awakened from my sleep due to my arm itching. The previous distinct dime sized circles had merged into one large red papule (oval shaped 3 inches long by 2 inches wide). I contacted Dermatology clinic for an appointment. In the meantime I applied Hydrocortizone ointment to the area and took a benadryl tablet orally for the itching. My doctors appointment is scheduled for 02/05/2021 at 10:30 AM.
60 2021-02-05 poor quality sleep At 11pm on the day I recieved the vaccine, I noticed my ears and neck were itchy. A half hour late... Read more
At 11pm on the day I recieved the vaccine, I noticed my ears and neck were itchy. A half hour later I had a bad sunburn like rash from my ears down to my chest and accross my shoulder s . I went to bed hoping it was just a quick reaction and it would go away. I took 2 benadryl.. When I woke up the next morning I felt like I was on fire. The rash spread over both arms around my torso and down to my hips. It was very itchy and painful. I called the doctor and he said it was an allergic reaction to the vaccine. To continue with the benadryl, go to urgent care or er if it got worse or if I had trouble breathing. My appointment for the second dose was cancelled. The rash wasn't clearing up when I went to bed so I rubbed cortisone 10 cream all over it and went to sleep. Had a restless night , got out of bed in the morning and both my hands were angry red and swollen as was the tops of my feet, the rash was a bit better on my arms, back and chest, but my buttocks down to my toes had angry red rash with welts, welts were also on my hands and wrist area I also had some chest tightness and a little difficulty swallowing. . I called urgent care to see if I could come in and I was told to go to er if I could drive or call 911. I went to er. The dr put me on an iv with benadryl, pepsid and a steriod. The swelling came down and the redness was easing up along with the pain. Dr. said it was a drug allergy, and I was allergic to vaccine. I was discharged with a prescription for prednisone and to continue the benadryl and pepsid for 5 days. I have no health insurance, I cant afford it.
60 2021-02-06 loss of personal independence in daily activities Less than 24 hours after Moderna Covid 19 vaccine #2, awoke with had severe muscle aches, fever, hea... Read more
Less than 24 hours after Moderna Covid 19 vaccine #2, awoke with had severe muscle aches, fever, headache and generalized fatigue. Essentially bedridden for 24 hours. No appetite. The next morning, still with fever, muscle aches and fatigue improved. Still with poor appetite. Also Red macular rash, about 3 inchX 2 inches at site of injection- resolved after 48 hours and another area of redness close to the injection site- resolving at 48 hours.
60 2021-02-07 insomnia PATIENT WAITED 15 MINUTES IN OBSERVATION. LEFT FACILITY, IN CAR, FELT AS THOUGH SHE HAD TROUBLE SWA... Read more
PATIENT WAITED 15 MINUTES IN OBSERVATION. LEFT FACILITY, IN CAR, FELT AS THOUGH SHE HAD TROUBLE SWALLOWING. HIVE APPEARED ONLY ON NECK. NOT OTHER SWEELING ITCHING OR BREATHING PROBLEMS. PT REPORTED THAT SHE WAS FEELING BETTER. BENEDRYL 50MG PO ADMINISTERED. VITALS: 97%O2 RA, 105 BPM, BP142/110. 911 CALLED, EMTS TRANSPORTED TO HOSPITAL FOR FURTHER EVALUATION.
60 2021-02-07 loss of personal independence in daily activities 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 2021-02-08 confusional state I became dehydrate and confused. This was noticeable in the hours leaving for the hospital at about ... Read more
I became dehydrate and confused. This was noticeable in the hours leaving for the hospital at about 8:00 p.m. Once at the hospital, I was combatant and didn't recognize family. I continued in this state while the Dr's at the hospital ran tests. Around the 16th and/or 17th, after 2-3 days of steroids, I could answer Dr's questions and recognized family.
60 2021-02-09 delirium Last Moderna vaccine taken at about 1015 am Friday, 02/05/21. Later in the day, left upper arm sore,... Read more
Last Moderna vaccine taken at about 1015 am Friday, 02/05/21. Later in the day, left upper arm sore, itchy as expected and started breathing faster, tired, laid down in bed about 8pm. About 1030pm, that Friday night 02/05/21 woke up stretching alot, was weak, had major aches, lots of stretching, fever 102.5, headache, shivering, very thirsty, was delirious for a couple hours, no appetite. I took tylenol a couple times during the reaction, started to break the fever early Sunday morning 02/06/21 about 1am. My clothes, sheets and blankets, even my pillow was soaked where my head and neck laid. I was so startled, I thought I peed on myself in bed at first, got up and changed clothes. Then just just laid a big towel on the mattress and got another blanket fell asleep again. About 2 hours later, I woke up shivering, was soaked again. I changed clothes once again and laid on the couch, had a terrible headache but fever went down. Headache was worse than earlier. Suddenly woke up and felt fine breathed better in months even, no fever. Got up, tried to work in the yard the last couple days but was too weak, just laid around, finally ate, found I had a mild fever of 99.9. It's normally like a 96.4. But Tuesday the 02/09 but went back to work 02/09/21 still had mild fever. I feel tons better today 02/10/21. No fever this am 97.1
60 2021-02-10 memory impairment Severe fatique, chronic pain, headache, swollen lymphnodes, memory and other cognitive symptoms mai... Read more
Severe fatique, chronic pain, headache, swollen lymphnodes, memory and other cognitive symptoms mainly with speech. This remains ongoing. Treatment: CuraPro, ProOmega, LDN
60 2021-02-11 nervousness Low grade temperature, shaking chills, muscle aches, headache, fatigue, nausea
60 2021-02-12 sleep disorder About 31 hours after the vaccine, I was woke up by pain amd itching on the site of my vaccine. Ther... Read more
About 31 hours after the vaccine, I was woke up by pain amd itching on the site of my vaccine. There was about a 1 1/2 inch raised welt on my arm. My arm continues to hurt and the welt is still there at 8:00 on 2/13/21
60 2021-02-15 restlessness COVID-19 Vaccine EUA; 14-15 hours after injection, developed chills, low-grade fever (99.9F), muscle... Read more
COVID-19 Vaccine EUA; 14-15 hours after injection, developed chills, low-grade fever (99.9F), muscle aches, malaise, restlessness (probably from fever). Symptoms lasted 24-30 hours after they started
60 2021-02-15 sleep disorder, mental impairment Awakened from sleep Fri. night with fever, chills, muscle spasms of jaw and feet, dizziness, nausea.... Read more
Awakened from sleep Fri. night with fever, chills, muscle spasms of jaw and feet, dizziness, nausea. Only able to doze off and on rest of the night d/t symptoms. Foot muscle spasms occurred approximately every 2 hours and lasted 5-10 minutes each time. Muscle spasms of jaw only occurred initially and lasted approximately 5 minutes. Spent Saturday going from couch to bed as symptoms continued along with feeling unable to function mentally & extreme fatigue. Tried to drink fluids, took Tylenol, ate only 6 crackers all day. Fever broke the following night and other symptoms gradually dissapated by Sunday evening. Still felt fatigued for 4 more days. Noted cellulitis on left arm 2 inches below injection site on Monday which lasted 1 week (redness approximately 3 x 4 inches with hardened area approximately 1/2-3/4 inch with itching/soreness).
60 2021-02-16 impaired work ability Tuesday in the early am, I woke up and I took my temperature - it was 101.2 (I had taken Ibuprofen 5... Read more
Tuesday in the early am, I woke up and I took my temperature - it was 101.2 (I had taken Ibuprofen 5 hrs prior). I got something to eat and then I took 800 mg of Ibuprofen. I bundled up - h ad chills and fever. Left arm was killing me. I went back to bed. I could hardly move my left arm. I oculdn't lay on it - the ibuprofen didn't work. I had to call out of work. I cancelled Tuesday. I was in bed. I drank a lot of water before the vaccine and after the vaccine. I had soup broth, tea, juice, cider. I slept 3-4 hour nap in afternoon. Diarrhea and cramps late tuesday night - bathroom and bed all of Tuesday. Had a fever again on Wednesday night - 101 (oral). Tired. Left arm was killing me. I continued 800 mg ibuprofen every 6 hours on Tuesday. I started VIT DE again. I was mostly exhausted and my arm still hurt badly. on Wednesday and Thursday. Thursday didn't take any ibuprofen - pushed through the day. On the 5th of February, for the first time in my life - left flank pain; sharp left lateral pain. I couldn't pee for three hours. I was drinking three quarts of water. For the most part, it didn't hurt a lot to move my left arm but it hurt. Bladder was not full even though I couldn't pee. I went to URGENT CARE - Doctor on Duty - (Friday, the 12th) UA - no nitrates; large amount of blood but everything was normal. No growth after 48 hours. Flomax - dialator and started to urinate. I didn't have any sense that I had to pee. Friday, the 5th, I took the Flomax once a day - 0.4 micrograms - I took it Friday and Saturday. I did abdomen warm compresses in my abdomen and back. I did it on Sunday twice, two. I started back up on Ibuprofen on Friday, Saturday. Monday - I got my PCM - Monday the 15th - He did a UA and I had no blood. I stopped Ibuprofen on Monday. He is going to do a renal ultrasound. I had never had a kidney stone but he has put in a referral to get that done. Tuesday (after President's day) - UA results - negative and no blood and he wasn't going to send it for culture. I still have minor left flank pain here and there.
60 2021-02-17 feeling abnormal The morning after my vaccine, I drank a half of cup of coffee and started feeling funny, went to the... Read more
The morning after my vaccine, I drank a half of cup of coffee and started feeling funny, went to the restroom and threw up and than I had this weird feeling kind of like a numbness that went from my arms down to my legs and my hands turned in like they were going to cramp up, I started breathing slowly and it all went away, I was fine after that. My left arm stayed sore for about 3 days, also when they gave me the shot I bled a little.
60 2021-02-18 sleep disorder, excessive sleepiness sore arm, fatigue, fever (got up to 102.4), headache: sore arm was right away (even with moving arm)... Read more
sore arm, fatigue, fever (got up to 102.4), headache: sore arm was right away (even with moving arm); fatigue began approximately 3 1/2 hours later; fever noticed at 1:30 am when I was awaken from shivering (12 hours after receiving vaccine) ~ at that time fever was 101.1; by 4 am, fever was at 102.4 and headache started. Fever stayed at 102.4 for approximately one hour then started coming down. By 2 pm fever was normal. Headache continued until I was able to get up and eat something to take Tylenol, went back to sleep right after taking Tylenol; when I woke up, headache was gone (not sure what time this was). FYI: spend most of the day (02/28/2021) sleeping. By Friday morning, felt more normal. Slight fatigue but nothing to prevent me from doing my normal routine.
60 2021-02-19 feeling abnormal 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 2021-02-21 feeling abnormal 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 insomnia Headache, chills, joint pain, severe fatigue, insomnia, some minor chest pain.
60 2021-02-21 poor quality sleep Woke up on 2/21 with a Migraine; then by 2:00 pm had nausea, chills, fever, tiredness. Did not feel... Read more
Woke up on 2/21 with a Migraine; then by 2:00 pm had nausea, chills, fever, tiredness. Did not feel good rest of day; did not sleep well and headache again this morning, 2/22/21.
60 2021-02-24 impaired work ability 4 days after getting the shot, I began having severe pain in my left hip, thigh and knee hamperin... Read more
4 days after getting the shot, I began having severe pain in my left hip, thigh and knee hampering my ability to ambulate x 2/3 weeks. At this time I am able to walk slowly with a limp, I continue to have almost constant pain in my left knee and frequent pain in my left buttock and thigh. I went to a chiropractor x 4 weeks. I am currently in therapy x 3 days a week. I saw a surgeon with the recommendation to continue with therapy. I was not having any back or leg pain prior to this. Currently , unable to work.
60 2021-02-25 restlessness 2/24/21 about midnight I was not feeling well. I was having stomach pain. At 3:00am (2?25/21) i woke... Read more
2/24/21 about midnight I was not feeling well. I was having stomach pain. At 3:00am (2?25/21) i woke hot and stomach pain was worse. About 4:00am diarrhea started. I never went back to sleep that day. At 6:00am after a shower I notice a bump by my left clavicle. I notice it was movement about the size of a nickel. I called Dr. office, they agreed to see me in the afternoon. At 3:30pm I saw Dr. said that it's lymph and I should keep an eye on it. He recommends an ultra sound if not better in two weeks. Left shoulder is painful and it is a little hard to type, but not a big deal. 2/25/21 about 9:00pm I went to the bathroom I had a bright red bowels. 2?26/21 I am waiting for Dr. (she has been my stomach doctor for many years) to speak with her about the bloody bowel. I will also call Dr. a message to keep her up
60 2021-02-28 anxiety 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 2021-02-28 feeling abnormal Dizziness, feeling like in fog, chills, fatigue, fever to 100.9, headache, pain in arm of injection.... Read more
Dizziness, feeling like in fog, chills, fatigue, fever to 100.9, headache, pain in arm of injection. Began about 04:00 AM on 2/28/21 and lasted until about 11:30 on 3/1/21 AM
60 2021-02-28 sensation of foreign body After receiving the vaccine on Thursday I had a very metallic taste. Shortly after breakfast on the ... Read more
After receiving the vaccine on Thursday I had a very metallic taste. Shortly after breakfast on the morning of the 25 I had a lump in my throat as though my food didn't go all the way down. Then, as the day wore on I got more & more fatigued; later in the day my lips were mildly numb. I had no appetite at supper time and started getting a headache along with chills. All day Saturday I had flu-like symptoms, chills (no fever) extreme tiredness and a dull headache and laid under a blanket all day, no energy. Saturday evening around dinner time I started feeling better and Sunday woke up feeling as though nothing had happened other than a dull headache and soreness at the injection site.
60 2021-03-01 feeling abnormal Sore arm, aches across neck and shoulders, minor chills, extreme fatigue, brain fog
60 2021-03-03 impaired work ability, confusional state, feeling abnormal Thurs, 2/25/21: became foggy of mind, very drowsy (ca. 10:00 AM),took Ibuprofen (2 X 200 mg generic)... Read more
Thurs, 2/25/21: became foggy of mind, very drowsy (ca. 10:00 AM),took Ibuprofen (2 X 200 mg generic) for intense pain in arm and myalgia, some fatigue in legs, had to take a nap, slept very heavily from 10:45 AM to 12:00 PM, woke suddenly, mind still foggy, took AM meds and shower (did walk about 2 mi - longer than usual with friend from 1: 30 P to ca 2:45 P), logged in to Contact Trace at 4 P and ate early dinner at ca. 4: 30 P, at ca. 5:00/ 5:15 PM was confused and very foggy, unable to focus and reason, stopped any phoning/ involved Contact Tracing effective 5:30 PM. Had a 4:00 PM to 8:00 PM shift planned, had to claim only a 1.5 hours of billable shift. Lost work due to inability to reason (afterwards only did background reading on COVID19 variants and regional impact, etc. Not billable work.)
60 2021-03-04 feeling abnormal Erythema, itching, dizziness, feeling "wierd". She was given IM Benadryl 25mg 12 minutes after her I... Read more
Erythema, itching, dizziness, feeling "wierd". She was given IM Benadryl 25mg 12 minutes after her IM injection of the Moderna vaccine (12:15) and that was repeated 25 minutes later (12:40). The patient was feeling better after each injection but after her 2nd dose of Benadryl she was still feeling dizzy and "wierd". She was transported to the ED by ambulance further treated there.
60 2021-03-04 sleep disorder Patient described to this PHN fever, chills, very sore arm starting the night after receiving the i... Read more
Patient described to this PHN fever, chills, very sore arm starting the night after receiving the injection. Soreness in arm continued for 3 weeks, on and off. Sometimes it felt like deep bone pain, she described as excruciating. Sometimes woke her at night. Did not occur every day. Some arm swelling. The injection was given at where she works. This PHN did not give the vaccine, but patient called to inform of reaction. We were going to complete this form together, but patient decided she'd do herself. I am not certain she will, so am sending the info I was told. She received 2nd injection 3/1/2021. Side effects seem less vigorous, by report, so far this time.
60 2021-03-04 sleep disorder My arm started hurting at 3pm the day of the vaccination The pain increased imand went to my shoul... Read more
My arm started hurting at 3pm the day of the vaccination The pain increased imand went to my shoulder. I was unable to move arms above head without extreme pain. I couldn't sleep because of pain. I am still having pain and going to a PT
60 2021-03-05 feeling abnormal 7 days after; vaccine rash 1 inch diameter, 9 days after; rash 2-1/2 inch diameter, 10 days after; r... Read more
7 days after; vaccine rash 1 inch diameter, 9 days after; rash 2-1/2 inch diameter, 10 days after; rash not grown but experiencing extreme fatigue, body aches, brain fog, body jerking, heavy breathing. I am reporting this on day 10
60 2021-03-06 nervousness, anxiety D10ECQ8 appointment moderna vaccination #1. Patient presented with mild cough, appeared nervous. u... Read more
D10ECQ8 appointment moderna vaccination #1. Patient presented with mild cough, appeared nervous. upon immediate assessment, the patient stated she was having difficulty swallowing. She was alert, respiration were easy and unlabored, skin was pink, warm and dry. Deep breaths, encouraged; patient responded to support and denied distress or shortness of breath. EMS evaluated patients, BP 128/80, O2 saturation 99% on room air. patient verbalized that she was feeling anxious and nervous about having had received the vaccination, but was feeling better after EMS evaluation. Patient was advised to share today's event with her PCP, and discuss recommendations for future vaccinations.
60 2021-03-07 amnesia She had not eaten but 15 minutes after injection, she felt as if her blood sugar dropping. She purch... Read more
She had not eaten but 15 minutes after injection, she felt as if her blood sugar dropping. She purchased a candy bar and ate it on the way. Her husband was driving. She does not remember trip. She was still feeling bad and they got a shake, she was not able to chew. They went straight home and checked blood sugar which was 62. This was approximately 1 hour after she ate candy bar. She started to feel better after another hour and ate a hamburger. She proceeded to sleep a lot the rest of the day. She stated she has never had a low blood sugar episode that severe before.
60 2021-03-07 anxiety No rxn to dose 1. Dose 2: @10 min had tingling of lips; at 12 min had tingling of tongue [and anxiet... Read more
No rxn to dose 1. Dose 2: @10 min had tingling of lips; at 12 min had tingling of tongue [and anxiety from the tingling]; @ 15 min had some SOB and knew this was not just anxiety. Had zero intention of being taken to ER as I could easily tx myself. Took inhalers, extra cetirizine. Did not take epi, though have several pens. @4 hour started feeling weak, severe arm pain. At 6 hours, unbearable arm pain, extreme weakness [did not take BP or pulse ox--though I can and wish I had]. Exceeding thirst, could not get water down fast enough. Reactivation of arachnoiditis symptoms. Started unusual muscle fasciculations in arms, leg, and face [face not normal for me]-took valium and baclofen. Next 36 hours unable Additional information for Item 18: next 48 hours, unable to get out of bed other than to get water. Severe HA upon waking [@16 H post injection]. Severe myalgias, but in areas of known arachnoiditis that have been quiescent for quite some time. Forgot to mention, as I find this strange: prior to going to sleep I had left eye conjunctivitis. Left eye only that still is slightly persistent and doesn't require any care [for me at least] I am currently 72 hours post. Still with HA and some fatigue, though worked today [I WAH for a population health company]. L arm is not as painful as the excruciating pain @ hour 4-16, and no need for additional acetaminophen. I have an exceedingly high pain tolerance due to the arachnoiditis, but this was the first time I took a narcotic in 5 years. 2 .5 mg oxycodone x1, then 600 mg ibuprofen x1, then 1 gm acetaminophen 2 over next 24 hours and nothing since, but it is still quite painful today. Different today than yesterday is the development of what feels like left shoulder bursitis. We'll have to see how this goes over time. There is extensive edema at the site, but not clear erythema [I'm dark skinned]. Still just can't seem to get enough water. Had my first meal last night [made chicken soup]. It's still pretty early on. I'm not even at the 72 hour mark yet, so hopefully things will settle down over the next weeks. I checked the box as life threatening because that was likely early anaphylaxis -- though at first I seriously thought at first I was just anxious because of the lip tingling. This is in defense of the fact I did not self administer epi when I became SOB. I likely should have, but know myself well and did fine without it and with asthma and allergy care. I didn't need extra albuterol after the first 24 hours [though writing this makes me feel SOB just from reliving it]. This second dose is a doozy. Hope this was helpful. I provided you guys with my cell but if you want to follow up, I use my phone for work so if you text first I cant tell you availability.
60 2021-03-07 impaired work ability, confusional state, excessive sleepiness Patient reports the evening of the vaccine in the middle of the night fever 103.5, body aches, "mass... Read more
Patient reports the evening of the vaccine in the middle of the night fever 103.5, body aches, "massive headache". The next night fatigue, could not articulate words, and was confused, fever. Reports sleeping alot and symptoms lasted 4 days. Could not work for 4 days. Today, 7 days after vaccine, continues to feel fatigued.
60 2021-03-08 disturbance in attention Pt reported have a feeling similar to how she feels prior to a seizure, although she did not progres... Read more
Pt reported have a feeling similar to how she feels prior to a seizure, although she did not progress into a seizure. In addition to an aura, she felt sluggish and felt like she was not thinking clearly. The feeling began "shortly after" her vaccination and has not completely gone away as of several hours later.
60 2021-03-08 feeling abnormal 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 excessive sleepiness Vaccination site became large red circle and has itched since day one. Approximately 48 hours later ... Read more
Vaccination site became large red circle and has itched since day one. Approximately 48 hours later I began to have a headache and ran a fever of 101.4 with body aches and slept almost the entire day. The next day my temperature was 100.6 with headache but no body aches but I had nausea for the next for the next 48 hours. I had really bad night sweats for 3 nights. On 3/8 I developed a red bump the size of a dime in the center of my rash on my arm. The arm has itched the entire time. On 3/9 I woke up feeling better finally but itching still persists but compared along with the other side effects it?s nothing.
60 2021-03-09 impaired work ability 03/09/2021 started at 1AM- temp ranging from 101-103.2, nausea/vomiting, weakness. took tylenol and ... Read more
03/09/2021 started at 1AM- temp ranging from 101-103.2, nausea/vomiting, weakness. took tylenol and drank water. Slept 90% of day. Called Health Clinic where shot given and was told Tylenol every 4 hours, these are side effects from injection 03/10/2021 temp 100-99.8. nausea, weakness, body hurts, head ache. Called my providers office at the Medical center and was told to alternate IBU and Tylenol, nothing else can be done. Have missed work both days as of now.
60 2021-03-09 irritability Approximately 5 hours after the shot these symptoms appeared: aches and pains, cramping, irritabil... Read more
Approximately 5 hours after the shot these symptoms appeared: aches and pains, cramping, irritability, exhaustion, headache. Upon waking the next morning I was shocked to find I am menstruating, at age 60, for the first time since February 2016. It's six hours later and I'm still experiencing menstruation, cramping, irritability and exhaustion. What is going on? I feel younger and more energetic.
60 2021-03-09 sleep disorder Burning, itching, severe swelling of the left arm for 2 weeks. Unable to use the left arms for at l... Read more
Burning, itching, severe swelling of the left arm for 2 weeks. Unable to use the left arms for at least a week. I was unable to even sleep on the left arm due to pain and swelling.
60 2021-03-11 feeling abnormal FIrst week: Left arm where dosage was given: hard like a ball, tender, sore. Body Achy, extreme fati... Read more
FIrst week: Left arm where dosage was given: hard like a ball, tender, sore. Body Achy, extreme fatigue. At wake up eyes dry Second week: Left arm still hard like a knot, feverish, skin area red. Facial cheeks red daily, Body aching, fatigued, Headache and in a daze - unclear foggy thinking. Third week: Left arm itchy, knot gone, redness gone. Body aches less minimal, less sleepy. Headaches are stronger and I drink about 1/2 gallon of water per day. Facial cheeks red on and off. Fogginess and dizziness still present. Next injection 03/19/2021 - same location and time
60 2021-03-11 feeling abnormal 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 sleep disorder 2 weeks after receiving first dose started having muscle aches from thighs down to feet. Worsened an... Read more
2 weeks after receiving first dose started having muscle aches from thighs down to feet. Worsened and by week 4-6 was having to take ibuprofen, Tylenol and naproxsyn multiple times per day with hardly any relief, even was awakened from sleep with discomfort. By week 7 pain was improving, only taking meds twice daily for discomfort now.
60 2021-03-12 disturbance in attention Experienced severe vertigo and an almost hallucinating effect rendering me unaware of my surrounding... Read more
Experienced severe vertigo and an almost hallucinating effect rendering me unaware of my surroundings even tho I was in total familiar surroundings at that moment..
60 2021-03-14 sensation of foreign body Within 15 min of receiving vaccine patient felt she had severe dryness in her mouth and throat. she... Read more
Within 15 min of receiving vaccine patient felt she had severe dryness in her mouth and throat. she felt a lump in her throat and tingling of her tongue. For the next one hour she was monitored. Her BP was in the 150/85 range, P from 94-84 bpm range and pO2 was between 94 - 96%. she was given 25 mg Diphenhydramine PO and was sent home independently. since her symptoms had improved. She was referred to the clinic's allergist and encouraged to contact her primary care provider.
60 2021-03-14 sleep disorder Pain at the injection site initially, then shooting up my neck towards my head on the left side of ... Read more
Pain at the injection site initially, then shooting up my neck towards my head on the left side of my neck. I took 400mgTylenol and went to bed. Then about midnight, awoke to sever aches and chills and an overall feeling of illness. I could not get comfortable and could not sleep. I was FREEZING and ACHING terribly. I also felt nauseous but did not vomit. I drank some white soda and ate a cracker and took some more Tylenol, again 400 mg, and went back to bed.. I took my hypertension pill as well. I slept this time for 4 hours. I woke up again and felt extremely weak, achy and cold. I had zero appetite. I drank an orange soda, took another 400 mg of Tylenol. I went back to bed and slept for another 4 hours. I woke up feeling like a truck ran me over. I sat up and watched a clip on the news about the Moderna shot adversely affecting women more than men. I knew how bad I felt and wished I had not taken the shot. I took another dose of Tylenol 400mg. I was up for an hour or so and then went back to bed, sleeping until 6:00 a.m. the following morning. I was feeling better the next day, not 100% but way better. I was able to eat. I took it easy the rest of the weekend.
60 2021-03-15 anxiety, feeling abnormal 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 feeling abnormal 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 2021-03-15 feeling abnormal Brain fog, fatigue increasing over 3 days resulting in 2 episodes of sleep paralysis. First lasting ... Read more
Brain fog, fatigue increasing over 3 days resulting in 2 episodes of sleep paralysis. First lasting about 2 minutes, second lasting about 15 minutes
60 2021-03-15 feeling abnormal Bad headache/migraine 3rd day, generally feeling bad from 3rd thru 5th day
60 2021-03-15 nervousness Patient felt light headed and extremely dizzy. Laid on floor to not feel so dizzy. Also felt extre... Read more
Patient felt light headed and extremely dizzy. Laid on floor to not feel so dizzy. Also felt extremely hot. Occurred approximately 15 minutes after immunization. Called 911 and paramedics evaluated her before taking her to the ER where she was released. Previously stated she was extremely nervous about receiving the vaccine.
60 2021-03-15 sleep disorder Beginning 3 hrs after the shot, and lasting 5 days, I was unable to raise my left arm due to pain in... Read more
Beginning 3 hrs after the shot, and lasting 5 days, I was unable to raise my left arm due to pain in my shoulder. The first night?s pain was intense and I was unable to sleep in any position. The slightest movement of my arm seemed to cause pain in that shoulder. It is almost
60 2021-03-15 sleep disorder Moderna shot at 5:30 pm on 3/14/2021. 3/15/2021 Body aches started, even nail beds hurt unable to s... Read more
Moderna shot at 5:30 pm on 3/14/2021. 3/15/2021 Body aches started, even nail beds hurt unable to sleep, difficulty breathing, cough. Took 2 Extra Strength Tylenol at 4 pm, 10 pm and 3/16/21 at 5:30 AM.
60 2021-03-16 confusional state, disturbance in attention I felt slightly dizzy within 15 minutes of receiving the vaccine, but shrugged it off as unimportant... Read more
I felt slightly dizzy within 15 minutes of receiving the vaccine, but shrugged it off as unimportant. I developed a slight headache within an hour of the vaccine. I continued to feel a bit dizzy and confused the rest of the day but didn't take anything for the slight headache. When I awoke this morning, I had a bad headache, chills, body aches all over, dizziness, light-headedness and confusion. I was so confused that I didn't remember making coffee for my son. I've also had difficulty concentrating or keeping on task. I took less than half of a Benadryl tablet about 45 to 60 minutes ago in case my body was experiencing an allergic reaction. Hopefully the dizziness and confusion will subside soon.
60 2021-03-17 anxiety Presents to ED after receiving 1st covid vaccine the day prior, now with SOB, nausea, emesis, fever,... Read more
Presents to ED after receiving 1st covid vaccine the day prior, now with SOB, nausea, emesis, fever, diaphoresis, "shakiness", "darkness on hands", cough, congestion, abdominal pain, anxiety. Normal immune response, d/c'd home in stable condition.
60 2021-03-18 sleep disorder Swollen and reddened face, headache, tingling lips, a little difficulty in breathing shortly after t... Read more
Swollen and reddened face, headache, tingling lips, a little difficulty in breathing shortly after the injection. The injection site on my left arm later bruised and was painful to the point of interfering with sleep. One week later, a painful red rash developed and spread on my left arm. I again began to experience slight difficulty in breathing.
60 2021-03-19 sleep disorder A few hours after l had the second dose, l had 103 fever for two days and 101 for one with EXCRUCIAT... Read more
A few hours after l had the second dose, l had 103 fever for two days and 101 for one with EXCRUCIATING shoulder/ rear felt pain and could not raise my arm for five days. Today is 15 days later and can raise my arm to 90 degrees only and have stabbing pain in the shoulder/ rear felt. Cannot sleep on it, keeps me up all night so I?m beginning to become concerned. I?ve tried Motrin,heat,ice and nothing is working and still VERY painful.
60 2021-03-21 feeling abnormal I am experiencing a Brain Fog and feeling scared, anxiety and cannot concentrate to do my job. Plea... Read more
I am experiencing a Brain Fog and feeling scared, anxiety and cannot concentrate to do my job. Please help me. It has been 1 week since I took the shot and I am still feeling this way.
60 2021-03-21 feeling abnormal 3/3 - very sore arm & achyness, 3/4 - sore arm continued, 3/5 - woke up with vertigo that subsided q... Read more
3/3 - very sore arm & achyness, 3/4 - sore arm continued, 3/5 - woke up with vertigo that subsided quickly, but dizziness, and headache on right side with brain fog continued, 3/7 - lymph node under right arm swollen and very sore and lasted about 1 week. vertigo in the morning stopped, but dizziness and headache continued, 3/9 - soreness in the arm is back with swelling, redness and itchy. this only lasted a couple of days 3/17 - dizziness and headache continued. dizziness is worse in the morning. developed a back spasm probably unrelated to the vaccine, but started taking meloxican for inflamation of the back. Coincidentally, it seemed to help with headache and dizziness. Still taking meloxican and headache and dizziness are minimal, but still present. Will be getting off the meloxican on Friday, 3/26, and we'll see??? 3/ 20 - started with fever blisters and mouth ulcers(probably from shot or stress all this has brought on my body)
60 2021-03-21 feeling abnormal day of vaccination, watery stool, stomach ache, tired, painful to lift arm up and down day after vac... Read more
day of vaccination, watery stool, stomach ache, tired, painful to lift arm up and down day after vaccination - Painful to lift arm up and down - light headed, fuzzy head, fatique, nausea two days after vaccination - Painful to lift arm up and down very light headed, fatique and nausea Three days after vaccination - arm sore but better, still light headed but better, fatique, nausea Four days after vaccination - arm better, very little light headedness, some fatique, nausea better
60 2021-03-21 feeling abnormal patient states "feels foggy" and dizzy starting 2 days post vaccine, still ongoing 4 days post vacci... Read more
patient states "feels foggy" and dizzy starting 2 days post vaccine, still ongoing 4 days post vaccine
60 2021-03-22 sleep disorder Red swollen arm from injection site halfway down and turning into underarm - length of swelling ab... Read more
Red swollen arm from injection site halfway down and turning into underarm - length of swelling about 12 inches . Painful, burning, keeping me awake at night. Accompanied by Pain in left underarm lymph node area. This is day 7 of this adverse event (today is 23-Mar 2021) and most severe day of reaction thus far
60 2021-03-23 feeling abnormal My right arm starting hurting 24 hours later, I cannot raise it up or down without lots of pain. I c... Read more
My right arm starting hurting 24 hours later, I cannot raise it up or down without lots of pain. I cannot move my arm around to my back without major pain. My left side of my neck-lymph note? hurts when I touch it. Aches and pains through my body, similar to a flu. Headache and very tired. My brain is foggy. This all happened approximately 26 hours later. I have iced, used heat and I buprofento try to calm the pain.
60 2021-03-23 nervousness patient states she felt "shakey"
60 2021-03-24 feeling abnormal, excessive sleepiness, impaired work ability When I arrived at work I was fine with in minutes my whole body felt as though it was spinning and I... Read more
When I arrived at work I was fine with in minutes my whole body felt as though it was spinning and I went to the ground, I began to sweat and got sick. I laid on the floor for about 15min they symptoms got somewhat better enough to sit up. I was sent home by my boss who also offered me a ride because I looked so awful. At home I went to bed but continued to throw up and have chills. I slept the rest of the next 2 days. I have continued to not feel well since the body aches and nausea as well as short of breath being the worst at this point. I felt in the beginning I was going to die it was so bad. I'm not one to just go to the doctors so I went home to bed. I have been short of breath
60 2021-03-25 feeling abnormal On day 3 post vaccine I started with Vertigo so bad I couldn't get out of bed. I also ended up with... Read more
On day 3 post vaccine I started with Vertigo so bad I couldn't get out of bed. I also ended up with pretty bad headaches, feeling like someone was squeezing my head, ear fullness and pain, brain fog, and the inability to walk straight without falling or bumping into the walls. Occasional Nausea. At almost week 3 I've tried Motrin, 1,000 mg a day, Psuedofed, as needed, Miclazine, and Vitamine C
60 2021-03-25 sleep disorder Sore arm right away - that evening I could hardly move my arm. When I woke up the next morning, I ha... Read more
Sore arm right away - that evening I could hardly move my arm. When I woke up the next morning, I had all of the symptoms that I had when I had the virus and I had 100.5 fever - headache; tired; achy. And those lasted not even a whole day and then they went away. Then the next night after that I couldn't sleep on the arm it hurt so bad. And the next day I noticed a rash - in the area around the shot on the top part of the left arm and it was burning and hot and it itched real bad. I took Benadryl. I went to the doctor (on the 18th or 19th - went for other reasons and I also showed her my arm) and she gave me some prednisone but I didn't take all of it because it started going away. I only took a day of the prednisone and day 6 it seemed to be going away. I have photos of it. My symptoms had resolved by second dose. 2/12/2021 - I had a headache for a day after the second dose but that was it.
60 2021-03-26 insomnia Have a little redness & bruising at injection sight (upper left arm). Left arm was sore late in day... Read more
Have a little redness & bruising at injection sight (upper left arm). Left arm was sore late in day of injection. Early morning of 3/26/2021 I had numbness & tingling in left hand which kept me awake on & off all night. Was extremely tired when I woke up. Later in the day on 3/26/3021 had a rash around elbow bone. Starting to fade now (early 3/27/2021). Mainly concerned if this was an adverse reaction & if it would affect effectiveness.
60 2021-03-27 excessive sleepiness 1st shot slight headache took Tylenol slept 2 hours felt better 2nd shot slight headache took Tyleno... Read more
1st shot slight headache took Tylenol slept 2 hours felt better 2nd shot slight headache took Tylenol slept 3 hours, a little better, just tired, next day body aches, joint pain, leg and feet cramps slept on and off all day, three day slightly better still body hurting and feet cramps.
60 2021-03-28 agitation, confusional state The patient received a moderna vaccination (unsure if this was her first or second dose) today at th... Read more
The patient received a moderna vaccination (unsure if this was her first or second dose) today at the vaccination site at a Stadium. She went back to her car and became very short of breath, confused, and became minimally responsive. 911 was called. Upon EMS arrival the patient was agitated and combative. She received 10 mg of versed. An OPA was inserted (sating at 98% on OPA) as she was unable to tolerate CPAP. Transported to Hospital. Given ketamine. Placed on BIPAP. ICU admit. History of CHF, COPD
60 2021-03-28 nervousness, sensation of foreign body Immediately after the shot, I felt very shakey. It improved in about 15-20 so I starting driving h... Read more
Immediately after the shot, I felt very shakey. It improved in about 15-20 so I starting driving home. While driving, I felt like I was developing a big lump in my throat and I started coughing. My throat became extremely itchy. As i reached home, my entire face and head became itchy. Lump and itchiness in my throat continued. Drinking cold liquids helped the lump some, eating was difficult but not entirely impossible. Breathing was ok, but the itching was intense. The next morning I had a slightly raised rash all over my back that was also itchy. Benedryl didn't seem to help. Issues last about 3 days.
60 2021-03-28 sleep disorder I expected a sore arm, but it hurt so much I could barely move it, and when I did, I winced in pain.... Read more
I expected a sore arm, but it hurt so much I could barely move it, and when I did, I winced in pain. As the night went on, my neck and shoulders became very stiff. Was unable to sleep due to the discomfort and pain, even after taking Advil. The following morning my lower back was aching so much I had to lay down. I was cold, but my hands and feet were super cold. I could barely eat and had bad heartburn when I did. The second night my teeth hurt. However, when I had the virus in December (recently tested positive for the antibodies), I had none of those symptons and did not feel as bad as I did from the vaccine.
60 2021-03-29 anxiety, feeling abnormal Peresthesias, "fuzzy" feeling. Thought to be anxiety
60 2021-03-29 anxiety C/o dizziness, feeling anxious, mild diaphoresis. Drank water, laid with feet up, rested for 5 min. ... Read more
C/o dizziness, feeling anxious, mild diaphoresis. Drank water, laid with feet up, rested for 5 min. Vitals stable. Stated "felt better" after 5 min of rest and opted to leave on her own.
60 2021-03-29 feeling abnormal extreme pain 1-10 = 15, hours of tears. Entire body experienced shaking, felt like my body was inje... Read more
extreme pain 1-10 = 15, hours of tears. Entire body experienced shaking, felt like my body was injected with poison. I was nauseous for over 36 hours, along with above pain and shaking. Headache, blurring vision also present. HOME TREATMENT: Alka Seltzer PM at 2 am calmed me until 5 am. At 8 am another Alka Seltzer pm - this only help with the need to vomit and I could nap for 15 mins or so before the pain just became too much. 2 pm 2 Bayer Asprin...I could only sip water, tea and 4 teaspoons of soup. 8 pm 2 more Bayer Asprin and 2 more at 2 am. Around 6 am the feeling of being full of posion, aches and headache subsided and I was able to sleep. I slept until 5:30 pm that night solid. Today is Monday and I'm a bit tired but feel much better. The churning in my stomach still comes but not often - only once today. Eating normal, just small amount once a day no appetite. I live 45 minutes out of town with 3 feet of snow...had the weather and my location not been an issue I would have gone to the ER...had I received no relief from the OTC I would have gone to hospital.
60 2021-03-30 anxiety 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 confusional state, feeling abnormal Received 1st Vaccine on March 18th at 3:45pm. At 9pm, noticed sore arm and tired. Next day at 9:45... Read more
Received 1st Vaccine on March 18th at 3:45pm. At 9pm, noticed sore arm and tired. Next day at 9:45am was week, not clear thinking, chills, muscle aches, headache, tired. Symptoms worsened throughout the day. Sever chills, throwing up, increased headache, and muscle aches, then later fever. Was taken to urgent care as temperature wasn't decreasing. At urgent care, they gave me a COVID-19 and flu test - both negative. Continued on Tylenol and ibuprofen. Symptoms continued over the next 3 days to a slight lesser degree. Continue to have adverse symptoms (headache, weakness, brain fog, and tired) and it has been 13 days. the last 2 days, i has just towards the evening when i 'hit the wall' with the symptoms and have to lay down for the rest of the night.
60 2021-03-30 feeling abnormal 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 feeling abnormal 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 panic reaction Pain at injection site - w/i 2 hours and lasting 5 days Fatigue - w/i 4 hours and lasting 4 days hea... Read more
Pain at injection site - w/i 2 hours and lasting 5 days Fatigue - w/i 4 hours and lasting 4 days headache - w/i 4 hours and lasting 3 days nausea - w/i 4 hours and lasting 3 days dizziness - w/i 4 hours and lasting 4 days joint pain - w/i 5 hours and lasting 2 days swelling of lymph nodes in throat leading to not being able to swallow saliva leading to panic - w/i 8 hours and lasting about 40 minutes then gradually reducing in size over the next couple of days
60 2021-03-31 feeling abnormal She got the vaccine and she immediately felt a warm flush in her left arm. She was ok, and waited f... Read more
She got the vaccine and she immediately felt a warm flush in her left arm. She was ok, and waited for a few minutes after. An hour later she felt that her tongue was very heady and the inner sides of her cheeks in her mouth were numb. She did not have problems with her throat, but the tongue was heavy. She was extreme tired, very, very fatigued. About 12 hours later her head started feeling dizzy like she was in a boat. Yesterday morning, 3/31/21 her whole body was aching and in pain, and she took one regular Tylenol that helped her through the day and by the end of the day she was so tired and out of it, and had chills from about noon, so cold that she was trembling. She also had warm feelings in her hand as well. She went to bed early and slept for about 9 hours as she was extremely tired. She feels a little better today, but not back to feeling completely well.
60 2021-03-31 feeling abnormal Splitting headache, swollen eyes and lymph nodes in neck, felt beat with a bat (hurt to be touched),... Read more
Splitting headache, swollen eyes and lymph nodes in neck, felt beat with a bat (hurt to be touched), injection site 3" in diameter and swollen and red, brain fog, could not lift head or arms for 24 hours, high temperature 102, extreme joint pain.
60 2021-04-01 feeling abnormal, sleep disorder 3/25/21: work up before 6 a.m. with extreme muscle pain that moved throughout the body. Spasm. Co... Read more
3/25/21: work up before 6 a.m. with extreme muscle pain that moved throughout the body. Spasm. Could not go back to sleep? Unable to get out of bed much at all. No appetite. Stayed that way all day and night; 3/26/21: body pain now localized to hips and low back. Extremely fatigued and nauseated, nauseated is without warning and need to stay upright to not vomit slightly with food or drink, feel extremely hot. Feel foggy headed. Later in evening, injected arm swelling and redness got severe and developed raised rash across front and back of upper torso and shoulders to opposite arm. The rash was extremely heat intolerant. 3/27/21: hip pain subsided, but still nauseated and rash is worse as it a swelling in injected arm. Finally took 25 mg. of benadryl and rested more. Still very tire d and no appetite or thirst at all. Nausea better. By 5:00 p.m. rash is improved and swelling lessening. Arm still bright red and swollen in patchy areas. The injected arm feels lumpy. Still belching and nausea. 3/28/21: feeling better overall, but still fatigued. 3/29/21: Returned to work (WFH), but still no appetite or thirst at all. 4/1/21: symptoms have finally subsided except for complete lack of hunger or thirst.
60 2021-04-01 impaired work ability, confusional state, nervousness 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 sleep disorder Started off with 3 fingers started tingling and partially numb, then that evening my arm started hur... Read more
Started off with 3 fingers started tingling and partially numb, then that evening my arm started hurting and the night I could barely move it, it started burning by midnight and my fingers started being numb and tingling again. I took a Tylenol but it did nothing, I was up all night with my arm hurting an tingling. By Friday it started getting better, but Tuesday my fingers started tingling again and my arm still hurts some. I had an upset stomach on the day I got the shot and Friday.
60 2021-04-02 feeling abnormal Shaking chills. Achy body. Fever 100.5. Slight headache and nausea. Exhaustion. Sore arm. I received... Read more
Shaking chills. Achy body. Fever 100.5. Slight headache and nausea. Exhaustion. Sore arm. I received the vaccine at 3:40 p.m. Sore arm within 2 hours. I began to feel effects (tiredness) around 9:00 p.m. Fever, chills, body aches became intense about midnight April 3 and lasted until 8:00 a.m. April 3 As of submission I am no longer achy nor do I have chills, but am tired and a little brain fog. Also, slightly congested in nasal passages.
60 2021-04-02 feeling abnormal Lungs feel odd. I can breathe fine. I can exercise. Just a different feeling than prior to the vacc... Read more
Lungs feel odd. I can breathe fine. I can exercise. Just a different feeling than prior to the vaccine. Still have the weird feeling. Sceptic about getting second dose. Also, had very swollen arm 9 days after the vaccine. I understand this is normal for older women.
60 2021-04-04 disorientation, confusional state Confusion disoriented and Respiratory distress. Admitted to hospital as 24 he obviously
60 2021-04-04 feeling abnormal, excessive sleepiness Following the first vaccine on 2/3/21 I just had localized arm soreness. Following the second vaccin... Read more
Following the first vaccine on 2/3/21 I just had localized arm soreness. Following the second vaccine on 3/10/21 I experienced mild flu-like symptoms with chills, achiness, brain fog and fatigue. All of the symptoms have resolved except for fatigue. Fatigue is on-going. I just feel different and have to take a nap during the day (when possible) due to lack of energy.
60 2021-04-04 feeling abnormal Day 1-dizziness directly after the vaccine Day 2-light dizziness, severe fatigue (slept all day), co... Read more
Day 1-dizziness directly after the vaccine Day 2-light dizziness, severe fatigue (slept all day), constant medium headache, body aches, fever between 99.4-100 F, severe brain fog, medium nausea and vomiting, very stuffy nose. I stayed in bed all day. Day 3- severe fatigue but less than Day 2, mild body aches and headache, fever of 100 all day, severe brain fog. I stayed in bed all day again. Talk about brain fog - it took me 10 minutes to type this, and I typing is a big part of my job.
60 2021-04-04 sleep disorder Tinnitus began immediately following vaccine. At nighttime when the surrounding noise is reduced an... Read more
Tinnitus began immediately following vaccine. At nighttime when the surrounding noise is reduced and the quiet occurs, I now find it difficult to fall asleep because there is a continual loud buzzing/ringing noise running throughout my brain and extending through my ear canals. I have never had Tinnitus and always pitied people that had the condition and never understood the issue, until now. There should be a warning on these vaccines that they may cause Tinnitus. In this instance, ignorance is not bliss because blissful sleep is no longer going to be allowed in a certain percentage of the population that receives these vaccines? I intend to contact my doctor for testing. I am disappointed that no one in charge has brought this to the attention of the public. We have the right to make factual decisions. There are numerous people suffering from Tinnitus currently being ignored. Given this condition, how can I take another vaccine knowing it could further exacerbate this problem.
60 2021-04-05 disturbance in attention 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 feeling abnormal, insomnia 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 impaired work ability starting about 24 hours after the first shot of the Moderna vaccine, i started feeling sick. Fever,... Read more
starting about 24 hours after the first shot of the Moderna vaccine, i started feeling sick. Fever, nausea, extreme fatigue, headache. fever and nausea, with occasional headache has been ongoing for 22 days now. Have missed a lot of work (i am a CEO of a public company). the fever spiked about a week ago and doctor prescribed a general antibiotic. fever went down for two days but then went back up. he doctor sent me for more blood work and i will be receiving results soon. i am due for the second shot in one week, but can't afford to get even sicker so won't be taking it. i do need answers to my current condition. i am sure the vaccine had adverse impact on my immune system.
60 2021-04-06 feeling abnormal Severe chills, Fever up to 102, arm soreness, fatigue, mental fog, headache. Tylenol taken every 4-... Read more
Severe chills, Fever up to 102, arm soreness, fatigue, mental fog, headache. Tylenol taken every 4-6 hours for 24 hours. Fever gone at 24 hours and other symptoms improved over next 24 to 48 hours.
60 2021-04-06 nightmare Loss of balance, severe muscle pain all over my body, sever nausea, massive headaches, exhaustion, t... Read more
Loss of balance, severe muscle pain all over my body, sever nausea, massive headaches, exhaustion, trouble staying awake, nightmares, sweats, chills, abdominal pain, excessive thirst. As of this writing going on for more than 24 hours.
60 2021-04-07 anxiety dizziness, lightheadedness, anxious, observation done, juice offered, symptoms resolved, pt went hom... Read more
dizziness, lightheadedness, anxious, observation done, juice offered, symptoms resolved, pt went home
60 2021-04-07 feeling abnormal 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 feeling abnormal SEVERE nausea days 3-5, severe chills days 3-6, mild headache day 4, moderate fatigue days 3-4, mild... Read more
SEVERE nausea days 3-5, severe chills days 3-6, mild headache day 4, moderate fatigue days 3-4, mild soreness injection site days 2-3, extreme brain fog days 3-5 and moderate brain fog (impairs function) days 6-10 and still ongoing.
60 2021-04-07 loss of personal independence in daily activities Moderately sore arm following injection. About 14 hours after vaccination, began to experience flu-l... Read more
Moderately sore arm following injection. About 14 hours after vaccination, began to experience flu-like symptoms: severe back pain, moderate pain in all joints from head to toe, chills surging through my body every time I moved, severe headache, aching back of neck, nausea, debilitating weakness, fatigue to the point I could not get out of bed. Headache was so bad I could not read, wear glasses, or even keep my eyes open for very long. I felt VERY ill, the worst I have ever felt in my entire life. Flu-like symptoms lasted almost exactly 24 hours. Low-level fatigue persisted past 24 hours. Regardless of this bad experience, I am happy to have been vaccinated and suffer through a short bout of side-effects rather than come down with COVID-19. I would certainly make the same choice again.
60 2021-04-08 disorientation, confusional state Severe chills, weakness, malasia severe joints pain in hands, elbows and knees, nausea Decreas... Read more
Severe chills, weakness, malasia severe joints pain in hands, elbows and knees, nausea Decrease appetite Generalized body aches Mental confused,, disoriented For 72hrs
60 2021-04-09 sleep disorder 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 sleep disorder I had a very, very severe headache and was nauseous for over 24 hours. I could not sleep even though... Read more
I had a very, very severe headache and was nauseous for over 24 hours. I could not sleep even though I was tired, would get out of breath easily, and had chills. After 24 hours I just felt run down for the next 24 hours.
60 2021-04-10 feeling abnormal 2 1/2 days after injection I have a large (2?x2.5?) red welt in my arm with a patch of not red in th... Read more
2 1/2 days after injection I have a large (2?x2.5?) red welt in my arm with a patch of not red in the center. It hurts and is very warm to the touch. It is NOT at the injection site but about 1.5? below it. 15 hours after injection: Extreme fatigue, head fog, chills for hours then hot for hours, extreme muscle and body aches, mild headache,
60 2021-04-11 depressed mood Prolonged severe headache, followed by persistent daily headache and persistent drop in mood.
60 2021-04-11 sleep disorder On April 8, I began to feel extremely tired and unwell. During that night, I woke up dizzy and feeli... Read more
On April 8, I began to feel extremely tired and unwell. During that night, I woke up dizzy and feeling sick to my stomach. I experienced extreme dizziness, jaw pain, headache, light sensitivity, vomiting (once), pain in my lower abdomen, several bowel movements, loss of appetite, and I slept during the day and night. It was very difficult to stand upright or walk. I began to feel better April 11 and was able to eat and walk. I still have a bit of dizziness and nauseousness, but I am able to eat, walk, and do daily activities.
60 2021-04-12 amnesia 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 2021-04-12 feeling abnormal 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 loss of personal independence in daily activities, confusional state, nightmare, disturbance in attention, excessive sleepiness Severe headache that woke me from sleep at 15 hours post vaccination; then at 24 hours post vaccinat... Read more
Severe headache that woke me from sleep at 15 hours post vaccination; then at 24 hours post vaccination, typical side effects began with chills, aches and tiredness. However, at 28 hours post vaccination, my fever climbed to 102. I had such severe body aches, I needed assistance to get up and was nearly impossible to walk or move. I had no appetitie. I decided to take 2 extra strength tylenol to aid in the fever/chills and severe headache. Unfortunately, two days prior to vaccine, I was diagnosed by CT scan that I had a kidney stone. It was being treated with Toradol, which I only took at bedtime with the also, prescribed Flomax. The Toradol did little to assuage my body aches, incidentally My fever only came down to 101.4 . It remained between 101.4 and 102 until 48 hours post vaccination, when it finally went down to 99.2. I could only get out of bed to use the bathroom. I drank at least 2.25L of water daily because I was flushing a kidney stone, so my fluid intake was very strong. I knew that many of my friends/relatives have had the 2nd shot, so I messaged with them, but nobody had had a fever over 102. I knew if I did not take anything, it would've easily been 103F. I was confused and couldn't gather my thoughts. Things had to be repeated to me, but fortunately, I slept a lot and the worst of the symptoms was during my sleep at night and I had horrid nightmares. By 56 hours post-vaccination, I could function, but I was severely exhausted. By 72 hours post-vaccination, I had tried to resume low level activity, but was too exhausted and took a 3 hour nap in addition to sleeping 12 hours/night since I had the vaccination 5 days ago. My arm is still very sore, but not as immobile as first shot. I still have very little appetite and my headache lasted 3 days. I'd consider myself general recovered from the worst of the fever, body aches and fatigue.
60 2021-04-13 feeling abnormal 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 impaired work ability 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 2021-04-13 sleep disorder Leg pain and some foot pain, appears to exaggerate pain that was present and now wakes me up.
60 2021-04-14 sleep disorder, insomnia Insomnia, joint and muscle aches and pain, earache, exhaustion, swollen glands. Desperately tired an... Read more
Insomnia, joint and muscle aches and pain, earache, exhaustion, swollen glands. Desperately tired and could not sleep all night. Aches, pain and fatigue continue the day after shot.
60 2021-04-14 sleep disorder 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 excessive sleepiness Fever, chills, body aches, joint pain, fatigue, headache. Fever and chills began about 12 hours afte... Read more
Fever, chills, body aches, joint pain, fatigue, headache. Fever and chills began about 12 hours after the injection; chills lasted for about 8 hours, then subsided. All other symptoms lasted for 24 hours after onset, with fatigue tailing off after about 36 hours. Symptoms were sufficiently intense that I slept for most of 24 hours, but not disabling -- I could get up and walk around, for instance.
60 2021-04-15 impaired work ability Extreme full body weakness- Full body soreness Sore throat Headache Blurry vision Fever- lasted for ... Read more
Extreme full body weakness- Full body soreness Sore throat Headache Blurry vision Fever- lasted for 4 days- treated with lots of fluids Advil Tylenol. Slept as much as possible. 5th and 6th day sore throat bad headache. Missed 4 days of work
60 2021-04-16 feeling abnormal 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 2021-04-16 feeling abnormal 9:30am About 10 minutes post vaccine client came to desk stating, "my hand feels funny and I feel a ... Read more
9:30am About 10 minutes post vaccine client came to desk stating, "my hand feels funny and I feel a little funny". Taken into quiet area, color pink, skin warm and dry. Denies dyspnea or pain. Offers no concerns after first vaccine. States left hand felt tingly so took watch off thinking it was too tight and states, "then I felt a rush like I might faint but that passed." BP on right - 226/120, pulse regular and strong at 88. Denies numbness or tingling anywhere else other than left hand. Speech clear. No drooping noted of face. Offers has been on BP pills for about 20 years - no change in prescription, no recent BP check, "due for annual". Took BP pill at 7:30am. BP 180/100, pulse remains regular at 86 and strong. No changes noted in color. Offers feeling improved with mask down. Offers breakfast of cake and coffee. BP rechecked and 200/120. Discussed going to Urgent Care for recheck and called husband to come to transport. Offers some tingling continues in left hand only - otherwise feels good. BP 230/98 on right and 160/98 on right. States "I'm feeling better" but still states that left hand remains slightly numb. Husband arrived. 9:55 Right BP 188/80 left 170/100. Pulse remains strong and regular at 88. Left with husband to seek care at urgent care. Given list of BP readings and requested husband to let us know outcome. This note has been signed and cannot be modified. To add more content, create an addendum note
60 2021-04-16 sleep disorder 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 2021-04-18 insomnia SEVERE CHILLS AND ALL MUSCLES SPASMED FOR HOURS, EXTREME FATIQUE, HEADACHE, WEAKNESS IN MY LEGS. IT ... Read more
SEVERE CHILLS AND ALL MUSCLES SPASMED FOR HOURS, EXTREME FATIQUE, HEADACHE, WEAKNESS IN MY LEGS. IT STARTED DURING THE NIGHT ON THURS OF THE SHOT. THE CHILLS AND SPASMS SUBSIDED BY FRIDAY MORNING. I WAS EXHAUSTED AND WEAK AND SLEPT ALL BUT 4 HOURS ON FRIDAY. DURING FRIDAY NIGHT INTO SATURDAY MORNING I WOKE UP IN A DRENCHED SWEAT. BY SATURDAY MORNING I FELT BETTER BUT WAS STILL WEAK IN TO SUNDAY AFTERNOON. I WAS ABLE TO GO TO WORK ON MONDAY THE 19TH .
60 2021-04-18 loss of personal independence in daily activities 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 2021-04-19 confusional state Patient reports persistent but less obvious cognitive change described as being in a cloud x 2 weeks... Read more
Patient reports persistent but less obvious cognitive change described as being in a cloud x 2 weeks. Reports received second moderna covid vaccine 4/6 at which time she experience right facial swelling around eye, tongue numbness, difficulty swallowing and confusion that began 20 min after injection. Reports she drove around for 2 hours trying to remember/find her way home and couldn't/didn't think to call husband. Did not take benadryl or attempt to trt sx with any other medication. Reports similar but more mild rx to initial dose 3/9
60 2021-04-19 feeling abnormal 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 2021-04-20 mental status changes, delirium Around 1 pm on 3/31 my wife developed an extremely high fever of 105.2 and sustained this for 90 min... Read more
Around 1 pm on 3/31 my wife developed an extremely high fever of 105.2 and sustained this for 90 minutes until I treated her with 1000 milligrams of Tylenol 2× over a 3 hour period. I also applied a cold compresses to her for head for 2 hours until fever gradually dropped to 101.5. Continued use of Tylenol every 4 hors after that kept her fever below 99. She also developed severe diarrhea for 2 days after recovering from her fever. She was in a delirious state of mind during the 24 hour period 1 day after her 2nd Moderna dose.
60 2021-04-21 disorientation 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 2021-04-22 anxiety dyspnea, anxiety
60 2021-04-22 feeling abnormal 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 feeling abnormal second shot had very sore arm first day, next day felt like flu aching joints mild headache later th... Read more
second shot had very sore arm first day, next day felt like flu aching joints mild headache later that day broke out in rash all over body. had to go to doctor on april 22,2021. now on methylprednoise and cetirizine and i'm itchey and hot and feel bad
60 2021-04-22 sleep disorder Left arm injection (felt no injection pain), within hours of the injection pain radiated down the l... Read more
Left arm injection (felt no injection pain), within hours of the injection pain radiated down the left arm into wrist, within twenty four hours weakening of the left arm, arm use became more and more challenging, shoulder pain radiated through arm at various arm positioning, weakening of the arm and use ability, used ibuprofen for pain treatment, could not sleep due to arm and shoulder pain, loss of arm use completely by April 16th. when patient sought out and received a Cortisone injection.
60 2021-04-23 delirium Went into the er because I was shaking like I was having a seizure and I was delirious. During the t... Read more
Went into the er because I was shaking like I was having a seizure and I was delirious. During the testing they found a blood clot in my lung. I am being treated with anti biotics and blood thinners
60 2021-04-23 feeling abnormal, nervousness 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 feeling abnormal Next day got extremely achy, mild headache, very hot/chills, didn?t have thermometer but felt worse ... Read more
Next day got extremely achy, mild headache, very hot/chills, didn?t have thermometer but felt worse than I remember flu being, I?m sure I had a fever. Slight sore throat. Felt bad enough to stay in bed. Felt horrible. Was told to start taking Motrin alternate with Tylenol. 2 days after vaccine took sick day, meds helped symptoms. Next day felt slightly achy and took Tylenol or Motrin a couple of times. Today is one week later, today I have slight sore throat and feel slightly warm but not enough to take meds yet.
60 2021-04-23 feeling abnormal fever 99.9 headache, chills, nausea, achy all over, sweats, miserable
60 2021-04-25 altered state of consciousness, feeling abnormal Brain fog so severe that I cannot even drive my car. My head is in an altered state, no clarity. I... Read more
Brain fog so severe that I cannot even drive my car. My head is in an altered state, no clarity. It feels like you are in a twilight or have had 4 drinks of alcohol. Terrible feeling that does not pass.
60 2021-04-25 anxiety Extremity swelling, throat tight, anxiety, rash, fever, headache, short of breath, oxygen saturation... Read more
Extremity swelling, throat tight, anxiety, rash, fever, headache, short of breath, oxygen saturations at 86%, edema, took benadryl and no relief so went to the ER
60 2021-04-25 feeling drunk Summary of Call: Patient received 2nd dose vaccine, return to work daycare (accross from street) 30... Read more
Summary of Call: Patient received 2nd dose vaccine, return to work daycare (accross from street) 30 min after and fell to the floor. Call our clinic for futher evaluation by provider. VS 140/85 right arm SPO2 100% temp 97.1 oral second reading 160/96. BG 145 HR 95. Pt was found sitting on a chair at parking lot of daycare across clinic 20-25vminutes after second dose of moderna She said she was feeling like drunk, VS as above her gait was weak and uncoordinated and was barely able to stand up, she was brought to hospital via car. Speech: Speech is normal; fluent and spontaneous with normal comprehension Cognition: The patient is oriented to person, place, and time; memory intact; language fluent; normal attention, concentration, and fund of knowledge Cranial Nerves: Trigeminal sensation is intact. The face is symmetric. The palate elevates in the midline. Voice is normal. Shoulder shrug is weak. Coordination: clumsy Gait: uncoordinated gate, wheelchair bound. EMS was called and transported to another hospital for Stroke work up
60 2021-04-25 impaired work ability The day after the injection, I had headache, chills, sweats, bad taste, fatigue, lethergy. One week... Read more
The day after the injection, I had headache, chills, sweats, bad taste, fatigue, lethergy. One week after I developed stabbing head pain, that continued off and on for several hours and several days. 18 days after I developed migraine that caused me to take time off work and go to bed.
60 2021-04-28 confusional state Extreme fatigue, chills and low grade fever (100) within hours. Fever over 102, 30 hours later with ... Read more
Extreme fatigue, chills and low grade fever (100) within hours. Fever over 102, 30 hours later with extreme chills, muscular pain, confusion. Symptoms continuing 52 hours later including extreme back pain.
60 2021-04-28 disturbance in attention, feeling abnormal "Moderna COVID-19 Vaccine EUA" After the first shot, I had the following side effects: Difficulty ... Read more
"Moderna COVID-19 Vaccine EUA" After the first shot, I had the following side effects: Difficulty swallowing and dizzy and unstable on my feet(started approx. 30 minutes after the shot and lasted approximately 30 minutes). Fuzzy thought process/ difficult to concentrate and tired all day.
60 2021-04-30 delirium Delirious; Severe flu like symptoms; Unable to use the cell phone; Joint pains; Temperature of 101.2... Read more
Delirious; Severe flu like symptoms; Unable to use the cell phone; Joint pains; Temperature of 101.2 F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirious) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Depression, Chronic pain, Hypertension and Hyperlipidemia. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and GABAPENTIN for Chronic pain, FLUOXETINE HYDROCHLORIDE (PROZAC) for Depression, ATORVASTATIN for Hyperlipidemia, LOSARTAN for Hypertension. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DELIRIUM (Delirious) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Severe flu like symptoms), IMPAIRED ABILITY TO USE MACHINERY (Unable to use the cell phone), ARTHRALGIA (Joint pains) and PYREXIA (Temperature of 101.2 F). On 16-Apr-2021, IMPAIRED ABILITY TO USE MACHINERY (Unable to use the cell phone) and PYREXIA (Temperature of 101.2 F) had resolved. On 17-Apr-2021, DELIRIUM (Delirious), INFLUENZA LIKE ILLNESS (Severe flu like symptoms) and ARTHRALGIA (Joint pains) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Pyrexia: 101.2 degree f (High) 101.2 degree F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included ibuprofen for joint pains. 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.; 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.
60 2021-04-30 impaired work ability Very dizzy with loud ringing in both ears. Fever, body aches, headache. I expected the fever/body ac... Read more
Very dizzy with loud ringing in both ears. Fever, body aches, headache. I expected the fever/body aches but the extreme dizziness makes driving/working not possible.
60 2021-04-30 insomnia 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 restlessness 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 2021-05-01 sleep disorder Diarrhea beginning 5 hours after dose, itching nose, skin hurting , whelp, reddness and tenderness r... Read more
Diarrhea beginning 5 hours after dose, itching nose, skin hurting , whelp, reddness and tenderness right upper arm by 7:00pm, chills followed by feeling extremely hot, drenched with sweat on day after injection, loss of appetite, nasal congestion, diarrhea persisted. Very fatigued but unable to sleep x 48 hrs.
60 2021-05-04 feeling abnormal Vaccine #1 Moderna given on Tuesday, March 30 at 10:00 am. Side effects were a sore left arm for abo... Read more
Vaccine #1 Moderna given on Tuesday, March 30 at 10:00 am. Side effects were a sore left arm for about 5-7 days and a slight injection site reaction of itching and redness for 10 days. Vaccine #2 Moderna given on Thursday, April 29 at 9:00 am. Right arm injection site reaction same as 1st vaccine for about 3-4 days, soreness for about 6 days. However, the main reaction: slight headache within 20-30 mins of the vaccine. I do not tend to have headaches and that is why this is noticeable. Didn?t take any pain killer (Tylenol) till the early evening. Took 1 pain med. Awoke about 7:00 am on Friday, April 30 to severe Vertigo. I have had vertigo in the past but not this severe since 1994 and almost no occurrences in many years other than momentary dizziness just before bed. I began to take antihistamine which usually clears it up but by Sunday morning was only slightly improved. I have not been able to drive for fear of an ?attack?. I am not experiencing full vertigo all day, but some dizziness, lightheaded ness as well. I also still Have the slight headache off an on during the day. I have also had a feeling of ?swimmy-headedness? and some brain fog (which has finally, mostly improved). I had looked at some discussion forums about this condition because I honestly didn?t want to connect it to the vaccine. I found a discussion on Saturday evening, May 2, and was shocked at the number of people who are experiencing my exact same symptoms, I decided to go to the dr on Monday morning, May 3. I was given Antivert. No improvement as of this morning, Wed, May 5.
60 2021-05-04 feeling abnormal 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 loss of personal independence in daily activities Headache started 12 hours after the 10 AM injection. Over the next 10 hours muscle aches and joint a... Read more
Headache started 12 hours after the 10 AM injection. Over the next 10 hours muscle aches and joint aches set in with severe chills and fatigue. Felt nauseated/ did not vomit. My eyes ached. I stayed in bed for 24 hours. Two days after the injection most of the symptoms had subsided but my vision was very blurry. I have experienced the same type of blurry vision after taking Nyquil, so I don't take it anymore. Now 3 days after the second Covid shot, my vision is clearing. I am developing a cold sore which I feel may be another reaction to the vaccine. I did not take any medication for the symptoms and did not report it to my doctor. I just wanted the fact of the symptoms to be included with the CDC data.
60 2021-05-05 sleep disorder Left arm hurts when placed in certain positions. The pain affects sleep as the stress of the arm st... Read more
Left arm hurts when placed in certain positions. The pain affects sleep as the stress of the arm stresses the neck muscles causing pain. It still hits a month after vaccine
60 2021-05-06 amnesia intensive lower abdominal pain, electrical nerve pain in right knee, Late night Charlie horse that w... Read more
intensive lower abdominal pain, electrical nerve pain in right knee, Late night Charlie horse that wrapped around upper abdomen (liver area), Massive headaches, severe leg pain (rt only)Working up from back of knee to top of thigh (VERY intense and most concerning because it felt very much like a blood clot, severe loss of short term memory for 3 days, Dizziness, loss of appetite, nausea All this starting on day following vaccine and for 5 days.
60 2021-05-06 feeling abnormal Day 11 of: Extreme Fatigue Chills Headache Loss of appetite Foggy head
60 2021-05-06 insomnia Symptoms started on 4/19 which was burning pain in my right outer hip radiating down my leg and also... Read more
Symptoms started on 4/19 which was burning pain in my right outer hip radiating down my leg and also into my groin. Pain was significant and Advil didn't help. Saw rash on my right buttock on morning of 4/22 and got diagnosed with Shingles at my doctor's office that same day. Was prescribed Acyclovir antiviral and Gabapentin for pain. Took the antiviral the prescribed 7 days. Have been on Gabapentin since. Amitriptyline was added recently because the pain continues to not be under control and sleeping is a challenge. It has been 19 days approximately since symptoms began and 17 days since diagnosis. I don't know the outcome yet since I still have somewhat of a rash left. The rash was large and and extended from the top of my tailbone down and out toward my hip down into the top of my thigh. The antiviral helped in that blisters never really formed, although I do have the burning pain and itching on the rash and also in the nerve following all through the route down into my foot and groin.
60 2021-05-11 impaired work ability Beyond the fatigue, I experienced dizziness that began decreasing two months after onset. It is sti... Read more
Beyond the fatigue, I experienced dizziness that began decreasing two months after onset. It is still not fully resolved. It made teaching online a challenge.
60 2021-05-16 impaired work ability Had 1st shot 4/15/21 only experienced sore upper arm. 2nd shot 5/13/21 same arm. Woke the next morn... Read more
Had 1st shot 4/15/21 only experienced sore upper arm. 2nd shot 5/13/21 same arm. Woke the next morning and went to work. (6:45am). By 8am I first started feeling extremely tired and then chills followed by headache and achy.. I excused myself from work and went home. Slept a couple of hours and woke with a temp of 102.2. (I used an infrared thermometer). Took 2 Tylenol and slept for another few hours. By late afternoon my temp spiked to 104.9. Taking another dose of Tylenol and cold compresses it eventually went down and felt relatively normal by Sunday morning.
60 2021-05-16 sleep disorder, feeling abnormal She got her vaccine, she was fine the first day, walking around, going to the mall, driving and no i... Read more
She got her vaccine, she was fine the first day, walking around, going to the mall, driving and no issues. She went to bed and about 8:55 she woke up and was freezing. She threw on an extra blanket on the bed and immediately she felt as if somebody had kicked her in the back with a boot all night long, and laid in bed and moan and drank water as she was thirsty. She laid in bed the rest of the day. She had pain in the injection site and swelling, and then she had joint pains. It felt like all of her joints had pain, slight headache. She took some Ibuprofen for her symptoms. Her husband came home and was able to assist her in eating and taking care of her. The following day she was still tired and fatigued for about a week, but she was able to function and do her normal routine of things.
60 2021-05-18 confusional state 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 2021-05-18 nervousness Pt complained of nausea/dizziness after 5 min at post-vaccination area. We gave her an icebag for he... Read more
Pt complained of nausea/dizziness after 5 min at post-vaccination area. We gave her an icebag for her neck and she was on the floor for the next 20 minutes for observation. Checked her BP twice-- 143/119 then 143/110. Pt was also on blood pressure meds. Pt also stated that she has not had anything to eat in the morning prior to the vaccine and that she felt a bit nervous about her second dose Moderna. We gave her some crackers and made sure she was ok before leavin
60 2021-05-19 sleep disorder -extreme body ache (lasting 3 days) -bad headache -lost of appetite for two days. -extreme fatigue a... Read more
-extreme body ache (lasting 3 days) -bad headache -lost of appetite for two days. -extreme fatigue and sleepiness -round redness around shot area which is very sensitive. Looks like a rash but it is not. -swelling in shot injection area with the redness. -extreme sensitivity to left arm in shot injected area. -I cannot lift my arm all the way up without pain and cannot lean on it or sleep on it without pain.
60 2021-05-20 feeling drunk DRUNK FEELING, DIZZINESS, SHAKING, BLURRY VISION
60 2021-05-20 loss of personal independence in daily activities Bad headache, 103° fever, dry eyes, eye pain, both ears hurt, unable to do any activity. Chills,Sev... Read more
Bad headache, 103° fever, dry eyes, eye pain, both ears hurt, unable to do any activity. Chills,Severe bone, muscle pain, no appetite. Fever rose from 99.2° to 103° during day. Evening sweating, weakness, dizziness
60 2021-05-21 feeling abnormal, impaired work ability, confusional state Moderna COVID-19 Vaccine EUA The 20th I started feeling bad all of a sudden. I was dizzy, weak, con... Read more
Moderna COVID-19 Vaccine EUA The 20th I started feeling bad all of a sudden. I was dizzy, weak, confuse, diarrhea, fever, just wasn't feeling well at all. I left work early and stayed home in bed for two days. I took Tylenol for the fever and sip ginger ale for the nausea. The 22 I'm still nausea, but feels a little better.
60 2021-05-23 sleep disorder After vaccination, the injection site was sore but a few days later I started having pain at injecti... Read more
After vaccination, the injection site was sore but a few days later I started having pain at injection site that progressively got worse. I started having a burning that went down my whole arm to my back and up shoulders and back area, and there was numbness in my fingers. I told the pharmacist I didn't know if I should get the 2nd dose in the same arm, but I did and everything intensified and the pain increased after I had my second dose. I reported it to my doctor and he thought it was just my muscle but it started after my vaccine. the doctor gave me Gabapentin and it kept getting worse and I couldn't use my arm, the doctor increased the gabapentin but it still didn't work and he referred me to a neurologist. I couldn't sleep at night, couldn't use the arm or lay on the arm and the doctor gave me prednisone and it helped a little, but when I stopped taking it, I went back to the same pain. I have tremors in the arm as well and it feels like there is a burning under the skin but it's not swollen, it feels like there is some numbness in it. He referred me to a specialist and I see them tomorrow.
60 2021-05-23 sleep disorder About 12 hours after vaccine was administered my arm at the vaccination site was very sore. I was e... Read more
About 12 hours after vaccine was administered my arm at the vaccination site was very sore. I was extremely fatigued. Even so I had a fitful nights sleep feeling cold and under blankets. The next morning I was quite ill. I had a fever, aches and pains, extreme headache even after taking Motrin. My arm at the vaccination site was so painful that I had trouble moving my arm. I spent the day in a reclined position only getting up to go to the bathroom. The next night I slept better and my fever broke in the middle of the night. I woke up the next day feeling better but still had aches and pains and fatigue. I basically spent the day sitting around and taking naps. My arm was still sore but I could move it on this day. By the end of the day I felt much better. I was able to move my arm freely at this time. The next morning (today) I felt almost well but extremely fatigued.
60 2021-05-24 anxiety, feeling abnormal 05/15/2021 1300: Received first dose of Moderna COVID vaccine. No issues. 05/16/2021: No issues. 0... Read more
05/15/2021 1300: Received first dose of Moderna COVID vaccine. No issues. 05/16/2021: No issues. 05/17/2021: No issues. 05/18/2021 0800: Some occasional vision blurriness as if my reading/computer glasses were smudged. I kept wiping my glasses all day. That evening, I was anxious and unable to settle down. I did not go to bed until 1:00 AM. 05/19/2021 0500: Brief strange chest sensation (not pain; not pressure; just a strange sensation). 05/19/2021 0800: Dizziness and more noticeable blurred vision which continued throughout the day. 1st BP at home 122/81 2nd BP at home 117/77 05/19/2021 0940: Brief strange chest sensation (not pain; not pressure; just a strange sensation) while driving to doctor's office. 05/19/2021 1015: I happened to have scheduled an annual wellness visit for May 19 at 10:15 AM with a new primary care physician because my previous PCP (in the same practice) has been on a very long medical leave of absence. I was dizzy and having some balance problems walking from the parking lot to the office. 1st BP 143/88 Temperature 97.2 Weight 222.1 EKG good 2nd BP 130/76 Heart: soft murmur Thyroid: symmetrical The blurred vision and dizziness were getting much worse during my appointment. Dr. said he thought the symptoms were likely a side effect of the vaccine but wanted to order an MRI to make sure my brain was OK. Dr. arranged a same day appointment at a Clinic for 3:00 PM. Dr. advised me to rest, stay well hydrated, and not skip meals. My balance was very bad leaving the office and remained bad for about 6 hours. Dr. called me with the results of the MRI and said there was no stroke or clot, and that he thought the symptoms would slowly dissipate. 05/20/2021 0800: I woke up with ringing in my left ear that sounded like a combination of soft static coupled with soft sounds at a higher pitch. The ringing lasted about 1 hour. I had dizziness and blurred vision throughout the day, but it was less severe than the previous day. 05/21/2021 through 05/25/2021: I have had much less dizziness and it usually occurs only in the morning. I still have occasional vision blurriness throughout the day. It is most noticeable when I am working at the computer. I feel as if I have a little brain fog because it takes me longer to figure out how to type some things such as my email address, passwords, etc.
60 2021-05-26 feeling abnormal 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 feeling abnormal Within a couple hours of the second dose my tinnitus exploded and got extremely loud. It has contin... Read more
Within a couple hours of the second dose my tinnitus exploded and got extremely loud. It has continued to be very loud. Also Followed by a continued fogginess and occasional dull headache.
60 2021-05-29 nightmare, delirium, confusional state Fever (101) 2 week Aches 4 weeks Chills 2 week Nausea 2 week Sleep paralysis 2 nights Chilblains ong... Read more
Fever (101) 2 week Aches 4 weeks Chills 2 week Nausea 2 week Sleep paralysis 2 nights Chilblains ongoing Breathlessness ongoing Tremors/ticks 2 weeks Psychosis 3 weeks Visual and auditory hallucinations 2 weeks Delirium 3 weeks Confusion 3 weeks Unable to track time 3 weeks Lethargy 4 weeks Weakness 4 weeks Nightmares 3 weeks
60 2021-05-31 loss of personal independence in daily activities, impaired work ability A little over two weeks after the vaccine my body became very sensitive. My feet started aching and... Read more
A little over two weeks after the vaccine my body became very sensitive. My feet started aching and, over a couple of days, the aches moved up my body. I kept needing to sleep during the day and was having a hard time completing my work. Mid week I felt like I had a fever, which I didn't. A few days later my body started to feel better but I just had a general blah feeling. During the next two weeks, I was having harder time doing things I would normally do - cook dinner, go shopping. I lost my appetite but just kept going. On 5/28, I went for my 3 month blood test to check on my liver. Numbers were very and I have done nothing else new to cause this change
60 2021-06-01 impaired work ability 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 2021-06-05 sleep disorder Muscle pain from top of buttox to behind the knee. So severe that moving causes extreme pain. Once ... Read more
Muscle pain from top of buttox to behind the knee. So severe that moving causes extreme pain. Once laying down cannot get up without extreme pain. Cannot roll over when sleeping due to the pain. Tylenol helps a bit but only for about 2 hours.
60 2021-06-06 confusional state, mental status changes, feeling abnormal 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 2021-06-06 impaired work ability, feeling abnormal, memory impairment Start date on 5/5/2021 Left arm and hand pain, Off balance. Left foot drags.Then Left leg,foot pain,... Read more
Start date on 5/5/2021 Left arm and hand pain, Off balance. Left foot drags.Then Left leg,foot pain,numbness, pins and needles, aches, 4th week moved to torso, aches and pain. Alway daily Headaches on right side of head, extreme tireness, hard to walk with out using my cane. 3rd week moved to right leg and foot.Always Brain fog, since the beginingg. Hard to remember things off and on. I need to rest and nap daily. Blurr vision 2nd week at home noticed. Wearing my eye glasses more. Ear pain and Dizziness/Vertigo on 5/16/2021 Doctor Prescribes Prednesone for 2 weeks. Helped somewhat. Taking Ibuprohen, CBD oil for pain, Doing stretches, yoga, PT exercises to strenght muschles, Chiropractic adjustments weekly and massage helps too. Going to try accupuncture next week. I think I have Gullian Barre Syndrom. I have all the symptoms due to the 2nd Moderma Vaccine on 5/5/2021. Cannot work. Missed a month of work now. May have to go on disability.
60 2021-06-06 sleep disorder pain at injection site with swelling after about one hour. About six hours later followed by flu li... Read more
pain at injection site with swelling after about one hour. About six hours later followed by flu like symptoms including high fever 102 with chills, fatigue, sleep disturbance, swollen armpit lymph nodes, intestinal discomfort, rash on shoulder and arm, and what I would describe as severe arthritic pain in pretty much all joints of body large and small. Fever subsided in about 24 hours but rash, fatigue, swollen glands and muscle and joint pain lasted at least five days. Diahrrea on days three and four. Little appetite entire time.
60 2021-06-10 anxiety Pt called call center on 5/10/21. Complained of sxs starting 4/30/21 headache,blurred vision felling... Read more
Pt called call center on 5/10/21. Complained of sxs starting 4/30/21 headache,blurred vision felling tired,slight occasional dizziness,right eyelid twitching on/off,diarrhea and feeling anxious. Pt was advised to go to ED for evaluation
60 2021-06-10 sleep disorder 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 2021-06-13 fear 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 feeling abnormal, anxiety 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 2021-06-16 disturbance in attention, loss of personal independence in daily activities, amnesia, excessive sleepiness, feeling abnormal 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 2021-06-16 feeling abnormal Fatigue, muscle aches, brain fog for weeks after 2nd injection. Symptoms sometimes accompanied wit... Read more
Fatigue, muscle aches, brain fog for weeks after 2nd injection. Symptoms sometimes accompanied with low grade fever
60 2021-06-16 feeling drunk Rolled onto my right side this morning and the room started spinning. Laid on my back for 30-45 minu... Read more
Rolled onto my right side this morning and the room started spinning. Laid on my back for 30-45 minutes as it stopped. Tried to roll back onto my left side, spinning started again, returned to my back. After about 30 minutes I slowly sat up, little dizzy. Thought it was maybe my sinuses acting up, so went to use my nasal sprays, walking through the house like I was drunk. Nasal sprays relieved some pressure in sinuses. Contacted my business partner who replied "It's the covid vaccine. My mom and I both had this problem." At work now, a little dizzy on and off, and a little bit of brain fog.
60 2021-06-16 memory impairment I have noticed some short term memory or recall issues that is noticeable by me. My family has also... Read more
I have noticed some short term memory or recall issues that is noticeable by me. My family has also noticed this delay of recall.
60 2021-06-21 panic attack 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 2021-06-23 depression Diagnosed with severe depression at the time of discharge; This spontaneous case was reported by a c... Read more
Diagnosed with severe depression at the time of discharge; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEPRESSION (Diagnosed with severe depression at the time of discharge). ) 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. Concomitant products included ZOLPIDEM for Difficulty sleeping. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Wife went to doctor on 05Apr2021 and was diagnosed with depression. On 28Apr2021, wife was hospitalized due to depression. According to the husband, wife damaged and burned his car and so he had to send her to the hospital. On 14May2021, wife was discharged and diagnosed with severe depression and was prescribed with 3 medications. On 14-May-2021, the patient experienced DEPRESSION (Diagnosed with severe depression at the time of discharge). The patient was hospitalized from 28-Apr-2021 to 14-May-2021 due to DEPRESSION. The patient was treated with FLUOXETINE HCL for Adverse event, at a dose of 20 mg once a day; OLANZAPINE for Adverse event, at a dose of 10 mg once a day and TRAZODONE for Adverse event, at a dose of 50 mg once a day. At the time of the report, DEPRESSION (Diagnosed with severe depression at the time of discharge) outcome was unknown. This case was linked to MOD-2021-221012 (Patient Link).; Sender's Comments: Limited information regarding this event has been provided at this time. Further information has been requested.
60 2021-06-23 feeling abnormal, disturbance in attention 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 2021-06-27 insomnia 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 2021-06-29 feeling abnormal Initially, I had pain running down my right arm from the shoulder all the way down. My fever was 101... Read more
Initially, I had pain running down my right arm from the shoulder all the way down. My fever was 101.5. I really couldn't do anything just pure exhaustion, body aches. I also felt light headed. I felt terrible for 3 days but better for 2 and then it came back including the pain in my arm. I just kept hoping that if I rest it would go away, I'm just so exhausted and malaise. After 3 weeks I saw my neurologist Dr. on march 31. the 8th or 9th of April I had bloodwork order from my Internal medicine. The long term I have digestion, brain fog, fatigue, vaginitis
60 2021-06-30 insomnia 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 2021-07-01 feeling abnormal the first vaccine i was just with a headache and a bit tired , after the second vaccine , i felt it ... Read more
the first vaccine i was just with a headache and a bit tired , after the second vaccine , i felt it coming on 3 hours , by 6 hours later i was getting achy , by 12 midnight which was 12 hours later i had sort of like flu symptoms , then shaking and teeth chattering uncontrollably ,i had a fever not sure how high it went . i took extra strength tylenol. i was feeling crumby still on day 3 but was much better then prior 12 to 24 hours. also very sore shoulder on both vaccinations. last night which was july 1 i woke and for a brief moment my teeth were chattering ,then it stopped. i have no sign of fever even tho i have a uti . i am on day five of antibiotics.
60 2021-07-02 feeling abnormal 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 2021-07-06 feeling abnormal 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 2021-07-06 loss of personal independence in daily activities RHEUMATOID ARTHRITIS SYMPTOMS ALWAYS START TO GET WORSE THREE TO FIVE DAYS PRIOR TO NEXT INJECTION; ... Read more
RHEUMATOID ARTHRITIS SYMPTOMS ALWAYS START TO GET WORSE THREE TO FIVE DAYS PRIOR TO NEXT INJECTION; Rheumatoid arthritis symptoms always start to get worse three to five days prior to the next injection; difficulty with buttons when getting dressed; sore muscle in upper right arm near shoulder joint with diffuculty and pain with raising arms and when sleeping on it; EXTREME PAIN; Wearing off effect; TINY RASH AT INJECTION SITE; sore muscle in upper right arm near shoulder joint with diffuculty and pain with raising arms and when sleeping on it; sore muscle in upper right arm near shoulder joint with diffuculty and pain with raising arms and when sleeping on it; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS SYMPTOMS ALWAYS START TO GET WORSE THREE TO FIVE DAYS PRIOR TO NEXT 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. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. In August 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS SYMPTOMS ALWAYS START TO GET WORSE THREE TO FIVE DAYS PRIOR TO NEXT INJECTION) (seriousness criterion medically significant), CONDITION AGGRAVATED (Rheumatoid arthritis symptoms always start to get worse three to five days prior to the next injection), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty with buttons when getting dressed), JOINT RANGE OF MOTION DECREASED (sore muscle in upper right arm near shoulder joint with diffuculty and pain with raising arms and when sleeping on it), PAIN (EXTREME PAIN), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), INJECTION SITE RASH (TINY RASH AT INJECTION SITE), MYALGIA (sore muscle in upper right arm near shoulder joint with diffuculty and pain with raising arms and when sleeping on it) and ARTHRALGIA (sore muscle in upper right arm near shoulder joint with diffuculty and pain with raising arms and when sleeping on it). At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS SYMPTOMS ALWAYS START TO GET WORSE THREE TO FIVE DAYS PRIOR TO NEXT INJECTION), CONDITION AGGRAVATED (Rheumatoid arthritis symptoms always start to get worse three to five days prior to the next injection), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty with buttons when getting dressed), JOINT RANGE OF MOTION DECREASED (sore muscle in upper right arm near shoulder joint with diffuculty and pain with raising arms and when sleeping on it), PAIN (EXTREME PAIN), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect), INJECTION SITE RASH (TINY RASH AT INJECTION SITE), MYALGIA (sore muscle in upper right arm near shoulder joint with diffuculty and pain with raising arms and when sleeping on it) and ARTHRALGIA (sore muscle in upper right arm near shoulder joint with diffuculty and pain with raising arms and when sleeping on it) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Very limited information regarding the events has been provided at this time. Further information has been request.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been request.
60 2021-07-07 anxiety 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 2021-07-07 disorientation, sleep disorder, excessive sleepiness After 2 nd dose?..8 hours after receiving, slept for 24 hours straight. Awoke with a huge red warm a... Read more
After 2 nd dose?..8 hours after receiving, slept for 24 hours straight. Awoke with a huge red warm area hard to touch and painful on my left arm. Not at the injection site ? just below and a bow the elbow. I have photos and reported to pharmacy. The unable to arouse for about 6 days. Continues to give time to recover?yet intense head, neck, Rt shoulder pain with no sleep, nausea vomiting. May 7 th, contacted my PCP. Referrals made?unable to see ortho until 7/14. Pain increases, lethargy,extreme fatigue, disorientation to time, dizziness with right sided weakness falling. Systemic joint pain , SOB . Took my own driving privileges away. Sought tx at Er on 6/27?no relief Again, ER visit on July 6th dx of cytokine storm is a cascade of exaggerated immune responses that can cause serious problems. The immune system contains many different components that help you battle infections. It includes many different types of cells that communicate with each other via signaling molecules, known as cytokines. Might have been life saving for me. Thank God I do not live where I would have been canceled, and piled in the back of a U Haul??how did that happen ?
60 2021-07-09 sleep disorder Within a week of receiving the second dose of the Moderna vaccine, I had the following adverse effec... Read more
Within a week of receiving the second dose of the Moderna vaccine, I had the following adverse effects. I was awakened from sleep by my teeth chattering rapidly. This happened a couple of times a week for the first month, after the second dose. Also, sometimes I would have facial spasms at the same time as the teeth chattering. Other times, only the facial spasms occurred. The facial spasms have continued and are still ongoing.
60 2021-07-10 depression Depression; Major depressive disorder; Felt painful and a little bit sour on the left arm; headache;... Read more
Depression; Major depressive disorder; Felt painful and a little bit sour on the left arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of MAJOR DEPRESSION (Major depressive disorder), DEPRESSION (Depression) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical history was not reported. Concurrent medical conditions included Penicillin allergy, Depression (major depressive disorder) and Psychosis. Concomitant products included ZOLPIDEM for an unknown indication. On 13-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 05-Apr-2021, the patient experienced DEPRESSION (Depression) (seriousness criterion hospitalization). On 28-Apr-2021, the patient experienced MAJOR DEPRESSION (Major depressive disorder) (seriousness criteria hospitalization and medically significant) and HEADACHE (headache) (seriousness criterion hospitalization). On an unknown date, the patient experienced MYALGIA (Felt painful and a little bit sour on the left arm). The patient was hospitalized from 28-Apr-2021 to 30-Apr-2021 due to DEPRESSION and HEADACHE, and then from 30-Apr-2021 to 14-May-2021 due to MAJOR DEPRESSION. The patient was treated with FLUOXETINE HCL at a dose of 20 mg; OLANZAPINE at a dose of 10 mg once a day; TRAZODONE ongoing since an unknown date at a dose of 50 mg once a day and PAROXETINE (oral) from 05-Apr-2021 to 28-Apr-2021 for Depression, at a dose of UNK, qd. At the time of the report, MAJOR DEPRESSION (Major depressive disorder) had not resolved and DEPRESSION (Depression), HEADACHE (headache) and MYALGIA (Felt painful and a little bit sour on the left arm) had resolved. Based on the current 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-2021-221026 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received on 05 JUL 2021 and Contains was updated patient details, vaccine details, and additional narrative information.; 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 2021-07-11 disorientation, confusional state Within 2 minutes of receiving the vaccine I felt very confused and disoriented. I was dizzy and una... Read more
Within 2 minutes of receiving the vaccine I felt very confused and disoriented. I was dizzy and unable to speak for several minutes. I was told to sit in a chair for a few minutes prior to returning to my in surgery. I sat there for at least 30 minutes before I started feeling better. I left and walked back to the main building and within the hour started running a high temp and chilling along with an intense headache. I left and went home and started having body aches and continued chills and fevers through out the evening and night . This continued for 4 days.
60 2021-07-13 feeling abnormal After the first dose I felt like a burning sensation. After the second one I kind of felt funky righ... Read more
After the first dose I felt like a burning sensation. After the second one I kind of felt funky right away. For about 3-4 days I did not feel myself. It has gradually gotten worse in my joints and my left breast its still tender. I got a mammogram done in 06/23/2021 and they told me that sometimes the vaccine make your lymph nodes get swollen. They told me there was nothing wrong. They told me to report this. 2 weeks after the second dose I also had a respiratory problem and they did 2 Covid tests and they were both negative. They put me in antibiotics.
60 2021-07-15 feeling abnormal, memory impairment, impaired work ability Acute demyelination disease - Around mid April, noted a gradual onset of brain fog but got to the po... Read more
Acute demyelination disease - Around mid April, noted a gradual onset of brain fog but got to the point that she was able to do her typical tasks at work. At first she thought is was from stress from the taxes. But this was progressive over 2-3 days and that she started to feel like she was on a boat and rocking but was walking fine. She does think she was having trouble with words or cognition at that time and thinks she was having mild issues starting at the beginning of April. . She was also having trouble with scalp tingling as well tingling of her feet. The MRI showed likely acute demyelination and so she was admitted and she received an LP that showed this was likely a Sjogrens flare rather than a new onset of MS. Not sure that the entire report is back as several markers are nor reported on, including ones related to sjogrens. But she did have oligoclonal bands and elevate IgG levels both of which can point to MS but also Acute disseminated encephalomyelitis which can happen with vaccines. There is one case report thus far with the COVID vaccine which she had in January and February. She was treated with 5 days of iv steroid infusion. She is not sure it helped except that the tingling resolved. She still feels that she is rocking and with brain fog. She followed up with Dr, Neuro a few days ago. He was concerned about acute prednisone withdrawal so he put her on a taper that just started yesterday. He thinks it is not MS but likely Sjogrens. She has a Rheum follow up in 3 weeks but was unable to find any one who could see her sooner. She also has an appointment but not until September. This was too long to wait, so she went to her PCP who helped her get to the Sjogrens center. They got her right in and she was assessed by the head of the department. He ordered repeat imaging of the head. Based upon the results, she was called by Neurology who admitted her directly for plasmapheresis therapy. Was told it is not Sjorgens but they are not sure what it it. She has another spinal tap and another MRI. They also wanted a biopsy but she refused. They ruled out lymphoma as much as they could without the biopsy. So they started plasmapheresis (PLEX) and she did just complete the 5th one and now the team is meeting to determine the next step. She also got high dose solumedrol when she was in patient. Notes that she is feeling better since then. She has been out of the hospital for about a week. Since the 5th PLEX treatment, she does not feel as wobbly and she is able to do more around the house. She no longer feels like she is rocking internally but still needs to steady herself. But cannot move quick or she would fall. She also notes that she has no stamina. But notes that multi-step tasks are very hard to complete. For example, she has made jam for as long as she can remember. She was not able to do and her husband had to finish it. Does not feel able to drive and feels that she is not cognitively capable of working as a nurse right now. She is currently on short term disability. She is supposed to hear back from the team as to what her next steps will be once they meet again as her last scheduled treatment today. Is still seeing acupuncture and it is helping. After the 5 PLEX treatments, the patient continues to note slowed cognition with persistent trouble with memory. There is no further treatment other to see what time does.
60 2021-07-17 feeling abnormal Itching throat; Light headed; Felt throat closing/Sensation of throat closing; Coughing; Abdominal c... Read more
Itching throat; Light headed; Felt throat closing/Sensation of throat closing; Coughing; Abdominal cramping; Red/itchy eyes; Red/itchy eyes; Nausea; Chills; Vomiting; Feel like crap; Left arm weakness; Hypersersitiver to other allergies; Still feel tired and rundown; had an allergic reaction; Weird feeling in throat; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Felt throat closing/Sensation of throat closing), COUGH (Coughing), ABDOMINAL PAIN (Abdominal cramping), EYE PRURITUS (Red/itchy eyes), OCULAR HYPERAEMIA (Red/itchy eyes), NAUSEA (Nausea), CHILLS (Chills), VOMITING (Vomiting), THROAT IRRITATION (Itching throat) and DIZZINESS (Light headed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anaphylaxis. Concurrent medical conditions included Bipolar disorder since October 2002, Thyroid disorder NOS, Premature ventricular contractions, Allergy to vaccine (Extensive history of allergic reactions to vaccines: flu vaccine, pneumonia shot, and tetanus shot (about 1993), Rash, cough gets really bad, itching, Have tried nasal shots .), Hypersensitivity reaction (Very long history), Hives and Anaphylaxis. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), LAMOTRIGINE and TOPIRAMATE for Bipolar disorder, METOPROLOL for Premature ventricular contractions, LEVOTHYROXINE for Thyroid disorder NOS, CLONAZEPAM and BUPROPION HCL for an unknown indication. On 18-May-2021 at 1:37 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-May-2021, the patient experienced THROAT TIGHTNESS (Felt throat closing/Sensation of throat closing) (seriousness criterion hospitalization), COUGH (Coughing) (seriousness criterion hospitalization), ABDOMINAL PAIN (Abdominal cramping) (seriousness criterion hospitalization), EYE PRURITUS (Red/itchy eyes) (seriousness criterion hospitalization), OCULAR HYPERAEMIA (Red/itchy eyes) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization), DIZZINESS (Light headed) (seriousness criterion hospitalization) and OROPHARYNGEAL DISCOMFORT (Weird feeling in throat). On 18-May-2021 at 2:00 PM, the patient experienced THROAT IRRITATION (Itching throat) (seriousness criterion hospitalization) and ALLERGY TO VACCINE (had an allergic reaction). On an unknown date, the patient experienced FEELING ABNORMAL (Feel like crap), MUSCULAR WEAKNESS (Left arm weakness), HYPERSENSITIVITY (Hypersersitiver to other allergies) and FATIGUE (Still feel tired and rundown). The patient was hospitalized from 18-May-2021 to 18-May-2021 due to ABDOMINAL PAIN, CHILLS, COUGH, DIZZINESS, EYE PRURITUS, NAUSEA, OCULAR HYPERAEMIA, THROAT IRRITATION, THROAT TIGHTNESS and VOMITING. The patient was treated with EPINEPHRINE 18-May-2021 for Adverse event, at a dose of 0.3 milligram, right upper leg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) ongoing from 18-May-2021 for Adverse event, at a dose of 25 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) on 18-May-2021 for Adverse event, at a dose of 50 milligram and DEXAMETHASONE (DECADRON [DEXAMETHASONE]) (intravenous) 18-May-2021 for Adverse event, at a dose of Long acting. On 18-May-2021, THROAT TIGHTNESS (Felt throat closing/Sensation of throat closing), COUGH (Coughing), ABDOMINAL PAIN (Abdominal cramping), EYE PRURITUS (Red/itchy eyes), OCULAR HYPERAEMIA (Red/itchy eyes), NAUSEA (Nausea), CHILLS (Chills), VOMITING (Vomiting), DIZZINESS (Light headed) and OROPHARYNGEAL DISCOMFORT (Weird feeling in throat) had resolved with sequelae. On 18-May-2021 at 4:25 PM, THROAT IRRITATION (Itching throat) and ALLERGY TO VACCINE (had an allergic reaction) had resolved with sequelae. At the time of the report, FEELING ABNORMAL (Feel like crap), MUSCULAR WEAKNESS (Left arm weakness) and HYPERSENSITIVITY (Hypersersitiver to other allergies) outcome was unknown and FATIGUE (Still feel tired and rundown) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered THROAT TIGHTNESS (Felt throat closing/Sensation of throat closing), COUGH (Coughing), ABDOMINAL PAIN (Abdominal cramping), EYE PRURITUS (Red/itchy eyes), OCULAR HYPERAEMIA (Red/itchy eyes), NAUSEA (Nausea), CHILLS (Chills), VOMITING (Vomiting), THROAT IRRITATION (Itching throat), DIZZINESS (Light headed), OROPHARYNGEAL DISCOMFORT (Weird feeling in throat), ALLERGY TO VACCINE (had an allergic reaction) and HYPERSENSITIVITY (Hypersersitiver to other allergies) to be possibly related. No further causality assessments were provided for FEELING ABNORMAL (Feel like crap), MUSCULAR WEAKNESS (Left arm weakness) and FATIGUE (Still feel tired and rundown). The patient had additional events to Flu and pneumonia vaccine like itching, the patient also tried nasal, shots. The residual effects included left arm weakness, continued Premature ventricular contractions (PVCs) for four days and still had hypersensitivity to other allergies 29 Jun 2021. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. It was reported since patient won't be getting the second shot, or one for the variant If there is one. She kept wearing mask and had never stop. But she also did not know abut the protection at all. Based on the current 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 01-Jul-2021: Follow-up received on 01 JUL 2021. Patient demographic (pregnancy, height, weight, race), Allergic history (Hypersensitivity reaction, Hives, Anaphylactic reaction.), Concomitant medication(Bupropion, Clonazepam), Event details ( Throat tightness, Vomiting, Chills, Nausea, Fatigue, Intentional product use issue, Feeling abnormal, Dizziness, Ocular hyperaemia, Eye pruritus, Abdominal pain, Cough), Hospitalization details, event outcome were updated. On 13-Jul-2021: Live follow up received on 13 JUL 2021. no new information was 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.
60 2021-07-20 delirium Delirium - several hours unaccounted for, severe diarrhea, chill sweats, fever, woke up the followin... Read more
Delirium - several hours unaccounted for, severe diarrhea, chill sweats, fever, woke up the following day with multiple facial bruising including massive black eye - cannot explain how it occurred
60 2021-07-20 delirium sudden extreme exhaustion, chills high fever, spasmodic vomiting. could not move out of bed, My tem... Read more
sudden extreme exhaustion, chills high fever, spasmodic vomiting. could not move out of bed, My temperature went quickly up to 103.7 and I was delirious not making sense when I spoke. I called the doctor and they prescribed an anti vomiting which helped and made me be able to drink fluids but I became very dehydrated and severely constipated for days after this event. It took my 6 weeks with strange ailments a long the way to feel better. On April 21st I could not see out of my right eye . I went to the walk in clinic who then sent me to the Hospital for a cat scan. They called it a visual aura which I never had in my life.
60 2021-07-20 sleep disorder, feeling abnormal 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 2021-07-21 fear at around 9:30 pm I went to the kitchen to get a drink and I began to experience hallucinations of l... Read more
at around 9:30 pm I went to the kitchen to get a drink and I began to experience hallucinations of large bugs coming out from under my stove towards me. I quickly got a broom to prove to myself that they were not real. I dropped my can of soda and it sprayed all over the kitchen causing me to fall. I still saw the bugs coming at me and I still had to convince myself that they were not real. I then proceeded to get another can of soda and fix my drink and the foam in the glass turned into a kaleidoscope of clowns. I have never in my whole life ever hallucinated and it was a very scary thing to have happen to me. I figured the best thing to do was go to sleep so I took my sleeping pills and tried to keep my eyes closed till i went to sleep. I slept all through the next day and when I woke at 5 am on the 22nd I was fine.
60 2021-07-22 insomnia, anxiety, restlessness Day 1- Fatigue, bad headache, body aches, hot flashes, sweats, arm soreness, fatigue Day 2- Severe f... Read more
Day 1- Fatigue, bad headache, body aches, hot flashes, sweats, arm soreness, fatigue Day 2- Severe flu symptoms included nausea, diarrhea, headache, body aches, restlessness, insomnia, fever, severe arm, neck and shoulder pain, sweats, fatigue Day 3- Nausea, loose stools, bloating, gas, headache, body aches, burning eyes, vertigo, fatigue, insomnia, anxiousness
61 2021-01-04 feeling abnormal Feeling dizzy, shakiness, and face pulsing. States "I fell like lost control of my body." Denies na... Read more
Feeling dizzy, shakiness, and face pulsing. States "I fell like lost control of my body." Denies nausea, shortness of breath, reash, or itching. She did have hives when she was given a flu shot last year.
61 2021-01-04 feeling abnormal NOT SURE THIS IS EVEN AN OUTCOME OF THE VACCINE, BECAUSE I HAVE HAD THE HEAD COLD AT THE EXACT SAME ... Read more
NOT SURE THIS IS EVEN AN OUTCOME OF THE VACCINE, BECAUSE I HAVE HAD THE HEAD COLD AT THE EXACT SAME TIME AS GETTING THE VACCINE ON JAN 31, 2020, BUT THOUGHT I SHOULD REPORT. 1. HAD A VERY MINOR HEADACHE THE TWO DAYS FOLLOWING THE VACCINE, JUST MILD DISCOMFORT. FULLY RESOLVED ON ITS OWN AFTER TWO DAYS. 2. MONDAY, JANUARY 4 WHEN I WOKE UP I FELT "PUFFY" - FEET AND HANDS WERE MILDLY SWOLLEN. NOTICED MY SHOES FELT TIGHTER THAN USUAL AND HANDS FELT A BIT DIFFICULT TO FULLY CLOSE. THIS IS FLUID RETENTION, AS IF YOU HAD TOO MUCH SALTY FOOD THE DAY BEFORE, AND I THOUGHT PERHAPS I HAD INGESTED MORE SALT THAN I REALIZED ON SUNDAY. BUT IT HAS BEEN YEARS SINCE THAT OCCURRED FOR ME AND MY DIET DOES NOT INCLUDE MUCH SALT OR PROCESSED FOODS. THEN TODAY MY FEET AND HANDS STILL FEEL PUFFY, SHOES STILL A BIT TIGHT AND HANDS A BIT HARD TO CLOSE SO THERE IS STILL SOME FLUID RETENTION GOING ON. THIS IS QUITE UNUSUAL FOR ME, I AM QUITE HEALTHY AND HAVE A GOOD DIET AND DON'T RECALL THIS HAPPENING BEFORE. AGAIN, NOT AT ALL SURE THIS IS RELATED TO THE VACCINE, IT MAY HAVE SOMETHING TO DO WITH THE HEAD COLD, BUT AS I AM NOT SURE AND THIS IS UNUSUAL AND HAS OCCURRED AFTER RECEIVING THE VACCINE, I FELT I SHOULD REPORT IT. THIS EFFECT IS VERY MILD AND I AM NOT CONCERNED ABOUT IT AND IT.
61 2021-01-05 sensation of foreign body 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 2021-01-06 feeling abnormal 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 anxiety Patient complained of being dizzy and having anxiety after immunization. Patient cleared by EMS. Pat... Read more
Patient complained of being dizzy and having anxiety after immunization. Patient cleared by EMS. Patient advised to call 911 or go to the nearest emergency room for any additional issues as needed. Also advised to sign up for v-safe.
61 2021-01-07 impaired work ability, feeling abnormal Shortly after receiving the vaccine (1/5/21) while waiting the 15 mins I experienced phlegm in my th... Read more
Shortly after receiving the vaccine (1/5/21) while waiting the 15 mins I experienced phlegm in my throat and kept trying to clear it, that resolved within 7min, I felt strange ...kind of dizzy and felt weird out of body feeling. They gave me water and crackers and said try to eat something for second shot. After 30 mins I felt OK to leave. During the rest of the day I had a headache which worsen and next day (1/6/) the same and had that weird out of body sensation off and on. I also had mild achy feeling, fatigue and both hips and shoulders mild pain. I did take this day off from work. These symptoms resolved towards the end of that night. Doing much better today (1/8/21). I aslo had mild swelling and sore at the injection site which I expected like a flu shot. I have not had any reaction to any vaccination prior years.
61 2021-01-07 impaired work ability Moderna COVID-19 Vaccine EUA Began with headache, flushed face then sore arm about 6 hours after inj... Read more
Moderna COVID-19 Vaccine EUA Began with headache, flushed face then sore arm about 6 hours after injection. Within 2 hours after I had severe chills, worsening headache with severe light sensitivity and nausea, severe heartburn, severe muscle aches, fever of 102.8, fatigue.
61 2021-01-10 poor quality sleep, memory impairment, sensation of foreign body 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 2021-01-11 restlessness 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 2021-01-13 impaired work ability Several hours after receiving vaccine(1/12/21) I showered and went to bed. Woke up around midnight s... Read more
Several hours after receiving vaccine(1/12/21) I showered and went to bed. Woke up around midnight shivering. Couldn't go back to sleep. Had tingling (spidery) feeling and took temp. 102.4. Started Tylenol every 4 hrs. Stayed home from work folling day. Fever through next evning. Return to work 1/14/21.
61 2021-01-14 impaired work ability Started with a bad headache then got worse. I worked until 11:30pm the day of the vaccine. Woke u... Read more
Started with a bad headache then got worse. I worked until 11:30pm the day of the vaccine. Woke up at 5:30 am with chills and body aches. Took off work. Fever spiked at about noon the day following the vaccine to 100.1 Tylenol then Ibuprofen was taken. By 6:30 am the next morning (today )all symptoms seem to be gone. I think it may be important to know that I was sick with covid 19 in April/May of 2020 for almost 3 weeks
61 2021-01-14 sleep disorder Mild asthma Arms site soreness unable to sleep due to pain on arm
61 2021-01-17 amnesia 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 impaired work ability intense soreness in arm , I could not get dressed, nausea and very intense diahrrea. After going to ... Read more
intense soreness in arm , I could not get dressed, nausea and very intense diahrrea. After going to the bathroom at 2:15 AM I had to lie on bathroom floor for 20 minutes. The rest of the day I experienced arm soreness, nausea and diahrrea. I could not go to work. The symptoms ended after 48 hours
61 2021-01-20 excessive sleepiness 1/19/21 - 5:00 p.m. started getting chills ... could not get warm, by 8:30 had 3 blankets on trying ... Read more
1/19/21 - 5:00 p.m. started getting chills ... could not get warm, by 8:30 had 3 blankets on trying to get warm ... uncontrollable shivering and shaking ... body aches and pains, bad headache - slept 14 hours ... Wednesday, 1/20/21 - extreme fatigue (may have been from no sleep the night before ), headache, muscle aches and pain), so much so I had to miss work - which I don't HARDLY every do. Thursday, 1/21/21 - just sore arm still and headache, but much better
61 2021-01-21 feeling abnormal Pt reported previous adverse reaction to an antibiotic that she recalls giving her hives. Due to th... Read more
Pt reported previous adverse reaction to an antibiotic that she recalls giving her hives. Due to this we observed her for 30 minutes following administration of vaccine. About 25 minutes into her observation period she began developing hives on her forearms and wasn't feeling her normal self. She denied any respiratory symptoms but was continuously clearing her throat and when asked if she normally did that, she stated that she did not. Decision was made to take vital signs and administer 50mg of IM Diphenhydramine. She was agreeable to this plan . After administering Diphenhydramine, we continued to monitor her vitals and had her stay another 45 minutes for observation. Hives resolved and vital signs remained within normal limits. Patient was education on allergic reactions and she to seek medical care. Patient verbalized understanding and felt back to her normal self.
61 2021-01-21 impaired work ability Onset this AM with fatigue, fever greater than 101.3, muscle and joint pain. Patient was sent home f... Read more
Onset this AM with fatigue, fever greater than 101.3, muscle and joint pain. Patient was sent home from work. Administration of COVID vaccination was 24 hours prior to onset of symptoms.
61 2021-01-24 feeling abnormal Day 1: Very sore arm leading to headache and neck stiffness. Minor brain fog. Day2: Same as above p... Read more
Day 1: Very sore arm leading to headache and neck stiffness. Minor brain fog. Day2: Same as above plus all over body ache & fatigue. Day 3: same as above plus very chilled (no fever) plus nausea and vomiting. Day 4: headache with minor aches. Day 5: only a hint of a sore arm.
61 2021-01-25 feeling abnormal Ongoing tingling to left side of face from forehead down to chin. Does not cross the midline. 1/16 a... Read more
Ongoing tingling to left side of face from forehead down to chin. Does not cross the midline. 1/16 at 3 am started with headache off and on, overall not feeling 100%. Rested and drinking fluids, without resolving completely.
61 2021-01-25 sleep disorder Neck on left side became extremely painful and sore and could turn my head didnt sleep the first nig... Read more
Neck on left side became extremely painful and sore and could turn my head didnt sleep the first night and had a slight headache. Everything was fine within 2 days. Like nothing happened. On Day 9 experianced a flash of light out of left eye and a floating blob that came and went throughout the day. Saw Dr and he said this is typical of the aging process. Dont know if it was related just weird it happened now. Arm was sore for 2 Days but nothing major. Other than that i felt fine.
61 2021-01-26 confusional state Received vaccine at 9:15am. At 4:30pm same day began to have weakness, dizziness, confusion, total b... Read more
Received vaccine at 9:15am. At 4:30pm same day began to have weakness, dizziness, confusion, total body joint pain, nausea and headache. Slight improvement by 1/27/21.
61 2021-01-26 feeling abnormal Pt is a pleasant 61 year old female who received Moderna COVID19 prime vaccine dose on 1/15/2021 as ... Read more
Pt is a pleasant 61 year old female who received Moderna COVID19 prime vaccine dose on 1/15/2021 as part of employee immunization event. Pt reported upper respiratory viral illness the week prior but determined with medical advice that she was well enough to be immunized on the 15th. Immediate post-vaccination period was unremarkable. Later that evening pt experienced onset of HA and fatigue which progressed to severe HA, low grade fever (~99 F per patient), malaise, and sore shoulder the following day. Symptoms gradually improved over the next 2-3 days with HA being the most troublesome and lingering symptom. Pt used OTC analgesics to manage HA pain. On 1/19/2021, four days after prime dose administration, pt noted a visible lump mid-clavicle, determined to be a severely swollen lymph node. Warm and tender to touch. Pt sought medical attention for this the following day, 1/20/2021. Physician's assessment: "Pt received the COVID moderna vaccine Friday, left arm. She is a triage RN at Medical Clinic. She states yesterday a lump appeared on her LT clavicle area. Pt reports the lump is tender, "warm" but not red, and no surrounding erythema. Yesterday had HA and a "weird sensation" radiating to LT ear from the lump. The lump is now the size of a golf ball, did draw a line under it to see it. She is able to swallow okay and has no other concerning Sx. No changes in breathing. Has had headaches, which have been reported possible side effect from COVD19 vaccination. This vaccination was given quite high in her arm she thinks as well. Fever Sunday night, 2 days after vaccination. Has been taking Tylenol and IBU (not what she does usually) taking with food and has some GI upset. Did try a cool compress on the lump yesterday which did not seem to help." // "Can clearly see her soft tissue mass above her left clavicle, with a line that she drove underneath it yesterday when it started to form. There is no redness but is certainly tender to touch. Can still see a little bit of bruise in her arm where her vaccine was given in her left arm which does seem quite high, not two finger widths from the acromion process. Discussed prednisone but she is terrified of this as she was given a Symbicort inhaler not that long ago and felt that the steroid really made her wired. Recommend warm compresses, alternate between Tylenol ibuprofen with food and even topical Voltaren gel which she has at home and Arnica gel to area. Can certainly get CBC CMP for further evaluation. Discussed soft tissue ultrasound if this does not improve, will order this today in case it is needed she can just get that scheduled. She is going to report her vaccine reaction to the link she was given on the paper which I think is appropriate. Hopefully symptoms will improve in the next few days and then can proceed with her second vaccination a month from the first." I spoke with patient today, 1/27/2021, to submit VAERS report. She reports swollen lymph node is still visible though size and sensitivity continue to slowly diminish.
61 2021-01-26 impaired work ability killer sore throat( felt like strep and never moved from the same site)and severe itching in nose, t... Read more
killer sore throat( felt like strep and never moved from the same site)and severe itching in nose, throat and ear severe itching spread to the mouth, tongue, inside of lip, then to big welps around mouth and on chin, then welps and severe itching on buttocks and a huge welp and itching 1 1/2" by 3" at injection site. Very tired and did not feel well. Low grade fever was sporadic. Could not go to work. Called Dr. about symptoms and prescribe antiobiotic of Ceftin for the sore throat.. Sore throat went away after 24 to 48 hours of being on medicine. By day 10 all the skin reactions had calmed down and by day 12 was feeling good. Dr. wanted me to report to you guys. He was unsure if I should take the 2nd dose of vaccine. He seemed confident throughout that this was an immune response to the vaccine.
61 2021-01-26 sleep disorder Day 1 - sore at site x 2 days; no redness, fever or other symptoms Day 10 - woke in middle of the ni... Read more
Day 1 - sore at site x 2 days; no redness, fever or other symptoms Day 10 - woke in middle of the night noticing discomfort at the injection site; in the morning large red circle ~3inch in diameter at injection site, very tender, some warmth; no fever of other symptoms
61 2021-01-27 disturbance in attention Headache (worse than normal, lasting all day so far) Chills Muscle aches Diarrhea Nauseous (did not... Read more
Headache (worse than normal, lasting all day so far) Chills Muscle aches Diarrhea Nauseous (did not throw up - yet) Tired Lack of concentration ability
61 2021-01-27 feeling abnormal 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 impaired work ability Patient reports she received 2nd Moderna vaccine lot #013L20A on 1/25/2021. Patient reports by 11AM ... Read more
Patient reports she received 2nd Moderna vaccine lot #013L20A on 1/25/2021. Patient reports by 11AM on 1/26, she felt achy, temperature 101.5, states "every joint hurt". Patient left work early 1/26 and stayed home on 1/27/2021. Today 01/28, Patient returned to work since fever resolved. While at work, patient was advised to contact Covid line who directed patient to get tested and quarantine at home. Patient adds injection site has grapefruit size redness, swelling, and feels itchy. Patient contacted her PCP and was advised to self monitor. Patient has intermittently applied ice. Patient takes Allegra daily. Manager suggested warm compress. Patient denies to see EHS. Patient will contact manager with update tomorrow 1/29. Will follow. VAERS.
61 2021-01-27 loss of personal independence in daily activities my second ( NOT THE FIRST ONE! ) vaccine received 0700hrs. 1/26/2021 ( my 2nd one ) By 2pm, extreme... Read more
my second ( NOT THE FIRST ONE! ) vaccine received 0700hrs. 1/26/2021 ( my 2nd one ) By 2pm, extreme exhaustion, tiredness, mild achiness all over, persistent mild headache. By that evening, fever ( not checked nor confirmed but probable) 14 hours after the vaccine with rigors. Body aches for 24 + hours after receiving vaccine. plus intermittent headache. By 36 hours later, still having intermittent fever (100.1 ) with body aches and sheer exhaustion. I am a nurse in an I.C.U. I had to call off work today, 48 hours after the vaccine. was received. Mainly for this persistent exhaustion. Also this damn headache still hanging around...mild but irritating. I know none of this is what I would call ADVERSE but my co-workers insist I need to fill out this information so I am. I it 50 hours from the vaccine and I am tired, slow and have to lay down and rest. It's stupid. My first vaccine was NOTHING . I have not had covid and I don't plan on it. :)
61 2021-01-28 poor quality sleep Left arm ached. Chills, body achiness. Didn't sleep well at night.
61 2021-01-28 sleep disorder Patient reported she started feeling chilled at work at 6:00pm that evening. Did not sleep well due ... Read more
Patient reported she started feeling chilled at work at 6:00pm that evening. Did not sleep well due to the arm pain form the injection site. Achy, low grade fever.
61 2021-01-29 anxiety 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 insomnia, impaired work ability I got the 2nd dose of the Pfizer vaccine late last Wednesday afternoon (1/20). Before the 2nd dose,... Read more
I got the 2nd dose of the Pfizer vaccine late last Wednesday afternoon (1/20). Before the 2nd dose, I premedicated (as instructed by my PMD office) with Benadryl 50mg and Pepcid 20mg (for the histamine blocking effect) since I had terrible itching for about 36 hrs after the 1st dose; but the itching didn't begin-after the 1st dose-until about 8hrs after the shot & became intense 2 more hrs later. I had itching the night of the 2nd dose that kept me awake part of the night but was FAR less intense than after the 1st dose. I came to work Thurs not feeling ill--just cold and tired all day (I attributed to the cold weather and not sleeping well). Thurs about noon I began feeling ill--like I was coming down with the flu; I went home after my shift and found my temp to be 100.4. Shortly thereafter it was 100.9. I thought it would pass by morning so I just showered, drank fluids, took Tylenol and slept. By 0200ish Fri 1/22 I still had a fever of 100.9 (even with Tylenol on board), a bad headache, sinus congestion, and significant neck and back pain so I called out for work. I continued to treat the fever and by noon Fri the fever finally had resolved-along with the head, neck and back pain. I've been fine since.
61 2021-01-31 insomnia Within 10 minutes of shot: slight nauseousness then throat instantly went completely dry. Kept cl... Read more
Within 10 minutes of shot: slight nauseousness then throat instantly went completely dry. Kept clearing throat. Drank 5 glasses of water. Took Benadryl that night to sleep. Next day slept only 41 minutes in 36 hour period. Followed that with a nap, woke up with migraine and vomited. I haven't vomited in over 25 years. Next two days had a slight headache. Then back to normal.
61 2021-01-31 loss of personal independence in daily activities 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 2021-01-31 sensation of foreign body, nervousness Pt received Moderna COVID-19 Vaccine Dose 1 at 0837. At 0843 pt started to complain of numbness and ... Read more
Pt received Moderna COVID-19 Vaccine Dose 1 at 0837. At 0843 pt started to complain of numbness and tingling in bilateral hands, right worse than left. Shaky feeling. Lightheadedness. Slight nausea. No dyspnea or numbness/tingling in face, neck, or throat. HR: 84 BP: 147/78 SP02: 95%-96%. At 0845, pt given apple juice and saltine crackers. Cool rags applied to neck. Stayed in room with pt to monitor. At 0900 pt laying back in chair, states she is feeling a bit better. HR: 74 BP: 128/73 SP02: 99%. At 0910, pt states that she is starting to feel like her throat is swelling and Convenient Care staff present by 0911. At 0913, pt was taken over to Convenient Care via wheelchair. At convenient care, pt presented with possible allergic reaction where she reported an allergy to peanuts and that she "has had reactions to other things". She had an injection site reaction to her first influenza vaccine (unknown year), but now receives them annually without issue. Pt reports she feels her hands are swelling, as her rings feel tight and that is not usually the case. Pt given diphenhydramine 50 mg IM x 1 and BP improved from 175/84 to 154/90. At 0940, pt reported she felt the lump in her throat was better and the rings on her fingers are looser. Pt spent about 1 hour at convenient care before pt was discharged to home. Pt diagnosed with allergic reaction to COVID-19 vaccine.
61 2021-02-01 feeling abnormal 1/11/21 received vaccine and had foggy brain, headache, lightheaded, dizzy, achy, nausiated, extreme... Read more
1/11/21 received vaccine and had foggy brain, headache, lightheaded, dizzy, achy, nausiated, extreme weakness 1/19/21, 8 days later developed the above symptoms in addition to a reaction at the injection site, left upper arm extremely swollen, welt, hard, hot, raised, itchy that lasted another 7 days
61 2021-02-01 poor quality sleep Pt started with headache that was relieved by taking Ibuprofen at 5am on the 28th. At first this was... Read more
Pt started with headache that was relieved by taking Ibuprofen at 5am on the 28th. At first this was effective. Pt had to continue to use ibuprofen alternated with acetaminophen during the day. By 6pm on the 28th, the headache became unbearable. No NSAIDS were helpful. Pt reports that it felt like the top of her head could pop off. Pt slept restlessly for the next 12 hours, but would awaken when the arm that received the injection would get bumped - that injection site was throbbing. Pt continues to have dull throbbing headaches daily. At time pt continues to take NSAIDS and reports this will most often take the edge off the headache.
61 2021-02-02 feeling abnormal Entire left upper arm became extremely swollen, red, hot to touch, chills, joint pain, transient dia... Read more
Entire left upper arm became extremely swollen, red, hot to touch, chills, joint pain, transient diarrhea, brain fog with occasional light headedness.
61 2021-02-02 feeling abnormal At 12 hours post injection (4am) I awoke with a profound headache, chills and severe joint pain. As ... Read more
At 12 hours post injection (4am) I awoke with a profound headache, chills and severe joint pain. As the day progressed I had a fever to 101 degrees, headache, joint pain and profound fatigue. Headache was unrelieved by ibuprofen or Tylenol. Thought process has been fuzzy, difficulty typing and completing sentences I also had vomitting x 2 on day one post vaccine but no diarrhea. Chills and fever persisted for approx 36 hours. Joint pain lasted x 36 hours. Headache continues now 5 days post vaccination. Per my employers request I was covid tested today 2/3 and my rapid results were negative. I continue to take ibuprofen and Tylenol for a continued headache. Thought process improved today.
61 2021-02-02 feeling abnormal Approximately 14 days after injection, my left arm developed large hives all over shoulder and inje... Read more
Approximately 14 days after injection, my left arm developed large hives all over shoulder and injection site. Only hives are on area of my arm of Covid injection. Some itching at injection site. Some lupus like symptoms- Brain fog; fatigue-joint stiffness.
61 2021-02-02 impaired work ability Had moderna vaccine 1/9/21 at 2pm. Around 3pm started getting chills/low grade fever /headache/swoll... Read more
Had moderna vaccine 1/9/21 at 2pm. Around 3pm started getting chills/low grade fever /headache/swollen right armpit node. Called supervisor and was told i could not come in with these symptoms. I was out of work for 2 days. Went back to work. Developed a non-productive cough/severe headaches lasting all day. Even if i took tylenol. Week of 1/18/21 Still had severe headaches/ cough/ chills/ no fever/ but started having a bad sorethroat/ chills and difficulty talking and swallowing. My throat lymph nodes were swollen. couldn't even swallow water but breathing was okay. Was sent to an ENT that same day. Had nasopharynscopy. Had slight swelling inside throat.
61 2021-02-03 poor quality sleep, feeling abnormal 3pm, day of injection, started getting real tired, no appetite, fell asleep at 7:30 pm on couch, le... Read more
3pm, day of injection, started getting real tired, no appetite, fell asleep at 7:30 pm on couch, left arm was hurting real bad, went to bed.. Tossed and turn and back hurting and arm all night. Woke up at 5am before alarm not feeling good. Had a real bad headache and sinus pressure in face area. My body was aching all over.. I took motrin 600 mil, at 5:30.. I had to go to leave for work at 8am. Feeling somewhat okay.. I'm a caregiver, i have clients who depends on me I started feeling sick, body aching. I left there at 10:30 am and arrived at next client .. My legs were not, i felt sick to my stomache and legs weighted down.. Went home very Fatigue. .
61 2021-02-04 feeling abnormal, nervousness 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 sleep disorder I had the injection at 11am., 2am I woke up with a severe headache, body aches, nausea along with 10... Read more
I had the injection at 11am., 2am I woke up with a severe headache, body aches, nausea along with 101.4 temp. This lasted until mid day, then just fatigue. Wednesday I got a large fever blister on my lip ( have had history in the past, not in some time though) Since then I have had an additional 3. 2 very large and not on my lip. Under by nose and as of yesterday on my lower cheek area. I was given Valtrex 1000mg take 2 then additional 2. Because of the frequent out breaks in the past several weeks, I started 500 mg daily. I am due for my next vaccine on Feb 9th, but I am concerned. ( I did have Covid 4/15/20 )
61 2021-02-05 feeling abnormal, sleep disorder 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 2021-02-05 sleep disorder, feeling abnormal Day after injection I woke up at 4:30 am with sore arm, severe headache,temp of 100.4 that went up ... Read more
Day after injection I woke up at 4:30 am with sore arm, severe headache,temp of 100.4 that went up to 102 through the day, body aches, slight cough,chills and just feeling terrible. I felt like I had the Covid Virus. Friday 2/5/21 and today Saturday 2/6/21 I am coughing with a throat that feels itchy and as if I am getting sick. I felt GREAT on Wednesday 2/3/21 and Thursday 2/4/21. I did call my Dr. the Day after injection when I was feeling so bad to see what to do about work because I can not take off work.
61 2021-02-05 sleep disorder IM vaccination was given in LUE deltoid. On the day of the vaccine felt slightly dizzy and more fat... Read more
IM vaccination was given in LUE deltoid. On the day of the vaccine felt slightly dizzy and more fatigued. The following day, I developed a painful, enlarged lymph node in left supraclavicular area. The next day I felt overall weakness and tiredness. No fever noted, but I was frequently flushed and had hot flashes with perceived sudden weakness. I had slight nasal congestion and prolonged sneezing spells on the following days. I had to find a place to sit down and remove my lab coat and turn down the heat because of hot flashes at work. I had fecal urgency and loose stool x 2 on 3/5/21. I have mild lymph node enlargement in left neck today (2/6/21) that is not painful. I had pain at the injections site for 2-3 days after the first vaccine injection that awakened me from sleep a couple of times. The second injection was given in the same arm. All of my symptoms are easily managed with Tylenol, Motrin, fluids and rest.
61 2021-02-07 poor quality sleep 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 2021-02-09 impaired work ability Missed 1 day of work due to fever, body aches, chills, headache, and sore arm.
61 2021-02-10 anxiety Approximately 40 minute after receiving the Moderna COVID-19 Vaccine EAU in my left upper arm , I e... Read more
Approximately 40 minute after receiving the Moderna COVID-19 Vaccine EAU in my left upper arm , I experienced a thickening of my tongue and a tingling feeling It felt as though it was in the forward part of my tongue. It felt very odd and was very scary. I had no tingling in my lips or in my throat. I could speak, drink water and eat. The sensation lasted approximately 5 hours until it felt somewhat back to normal. I have my second doze of the Moderna vaccine scheduled for March 5. I am worried about getting it after having this reaction. Please advise me.
61 2021-02-10 disorientation The following morning the headache started - right-sided, intense - staying for the better part of t... Read more
The following morning the headache started - right-sided, intense - staying for the better part of the past 2 days; R-sided numbness/tingling; Dizziness/lightheadedness - at times disorienting - most of the day after the dose. That night my temperature rose to 100-100.7; By morning 2 days after the dose the fever was gone, as was the tingling and dizziness; but the headache remains. Excedrin XS and drinking a lot of water helped to relieve some of the symptoms. There's still some pain at injection site, but I expected that.
61 2021-02-10 impaired work ability Fever 101.7, boby aches,chills, unable to work, injection site soreness and feverish. Everything on ... Read more
Fever 101.7, boby aches,chills, unable to work, injection site soreness and feverish. Everything on my body hurt.
61 2021-02-10 sleep disorder 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 feeling abnormal Severely painful joints and muscles, mental fog, headache, nausea, chills, fatigue.
61 2021-02-11 loss of personal independence in daily activities, impaired work ability Developed lightheadedness, dizziness, progressively worsening headache, dense ringing in ears, extre... Read more
Developed lightheadedness, dizziness, progressively worsening headache, dense ringing in ears, extreme fatigue and sleepiness (sleeping 14 hours first night, 12 hours second night), unable to stay upright for more than 30 min, nausea, body aches, fever, chills, sweats, muscle weakness, totally unfunctional, Call out sick to work for 2 days; Tx'd w/ advil, ubrelvy rescue med for fever, headache w/ some relief
61 2021-02-14 disturbance in attention, impaired work ability 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 2021-02-14 insomnia Facial paralysis; Shaking all over her body/shaking for 8 days; Can not sleep; Whole body hurts and ... Read more
Facial paralysis; Shaking all over her body/shaking for 8 days; Can not sleep; Whole body hurts and it does not go away; Terrible chills and shivers; A spontaneous report was received from a consumer who is a 61-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced facial paralysis, terrible chills, shaking for 8 days (tremors), shivers, cannot sleep (insomnia) and whole-body hurts(pain). The patient's medical history was not provided. Concomitant medications were not reported. On 13 Jan 2021, the patient received their first two planned doses of mRNA-1273 intramuscularly in her left arm for the prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient experienced terrible chills, shaking for 8 days, shivers and cold all the time, cannot sleep and whole-body hurts. On 28 Jan 2021, the patient experienced facial paralysis which was getting worse more on right side then moved to the middle of her face. The patient was given steroids. Treatment for the events included steroids. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, facial paralysis, terrible chills, shaking for 8 days (tremors), shivers, cannot sleep (insomnia) and whole-body hurts(pain), were considered unknown.; Reporter's Comments: This case concerns a 61-year-old female who experienced a serious unexpected event of facial paralysis, the non-serious unexpected events of tremors, insomnia and pain, and a non-serious expected event of chills. Events began on 21-Jan-21 after the first dose of mRNA-1273 on 13-Jan-21. Treatment with steroids. Outcomes unknown. 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.
61 2021-02-16 confusional state Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: 5 minutes after taking the vaccine pt stated that she felt dizzy and lighheaded. After about 10minutes later she started grabbing her throat indicating she cannot breath. we gave her 2 epipens 5 minutes after the 1st dose and called the ambulance
61 2021-02-16 impaired work ability 2/2/21: Started with severe chills and initial temp of 100.4. Approximately 45 minutes later, became... Read more
2/2/21: Started with severe chills and initial temp of 100.4. Approximately 45 minutes later, became dizzy & nauseated; temp was up to 101.6. Was laid down at work, evaluated by one of our Providers, provided Tylenol & Zofran and directed to go home; had to call son to drive me home because dizziness had worsened. After getting home, severe chills and development of body aches; remained on the couch rest of the night, using Tylenol for the fever and body aches. Had to call into work the next day (2/3/21) for continued fever, body aches, severe fatigue and chills (less severe); slept most of the day only drinking liquids. Went to work the next day (2/4/21), since temp was down, but still experiencing body aches and fatigue; ended up leaving work early, around 2:00PM because of weakness, slight dizziness and body aches. Rested the remainder of the day and was symptom-free by Friday, 2/1/21.
61 2021-02-16 mental impairment Achy sore/heavy muscles (current to date) , fatigue that grew worse daily ( and current to date) , w... Read more
Achy sore/heavy muscles (current to date) , fatigue that grew worse daily ( and current to date) , whole body chills that lasted 2-3 hours (until 1/25 and now on occasion) , night sweats ( 1/12-1/25) , diarrhea (1/23 - 1/25), headache (1/25 to current date), dizziness (1/25). On Jan. 25: Went to bathroom around 3:15 p.m. with diarrhea and became woozy so decided to get off of the toilet and sit down on the floor. Husband found me semi conscious on the floor with drool at about 4:10 p.m. He tried to awaken me and found me not lucid, speech was garbled, fragmented responsiveness and could not keep upright position, could not give details to the situation. Husband called 911. Ambulance transported to hospital ER during hospital exams and tests patient was not lucid and this continued for the next 32 hours. EKG, EEG, CT scan, MRI, Blood/Lab work; all tests were negative indicating no seizure , healthy heart, clear brain scan, no stroke, white blood count normal, dehydrated. All tests negative with all doctors unable to find a reason for this situation other than the Moderna vaccine considered highly for the situation. Advised patient not to take the second dose of Moderna.
61 2021-02-17 confusional state on 2/16/21 PM home health nurse administered 1st COVID vaccine Moderna dose to the patient - patient... Read more
on 2/16/21 PM home health nurse administered 1st COVID vaccine Moderna dose to the patient - patient had no immediate reaction in the first 30 minutes after the vaccination. on 2/17/21 AM visit (about 8:50am) - same nurse - patient was found confused, unable to speak in full sentences, repeating herself , "really off". Patient had tremors throughout her body, had abnormal vital signs - temp 98.8, HR 112, RR 24 and labored breathing, BP 88/42, O2 saturation variating constantly between 88-96% on 4 liters O2. Patient initially refused to have 911 called. Nurse has called patient's PCP and PCP spoke with patient who then agreed to call 911 to go to a hospital. 911 was called, report given to paramedics, the patient taken to local ER. Per patient and family - some tests were done in ER (?including CT of head from patient's description). Patient's cognitive status and vital signs have improved and patient was sent home. Per ER, they think this was a reaction to the COVID vaccine. Today 2/18/21 AM visit, same nurse - patient's cognition is at baseline. Patient seems very tired but vital signs are better.
61 2021-02-18 sleep disorder Excruciating pain approximately 2 1/2 hours after inoculation in my non-dominant shoulder. Unable t... Read more
Excruciating pain approximately 2 1/2 hours after inoculation in my non-dominant shoulder. Unable to move my arm without help of dominant hand. Area vaccinated, warm to the touch. Took 2 Tylenol 8-hour and kept ice on shoulder all night. Slept for about 4 1/2 hours; awakened by pain. Continue to ice upper arm. Called primary care physician and spoke to a covid doctor who said this is common, monitor for 48 hours and continue doing what I've been doing. If continues, can see my doctor or specialist.
61 2021-02-19 disorientation, delirium Fatigue since 2nd vaccination. On 2/19 woke up just before midnight with delirium according to par... Read more
Fatigue since 2nd vaccination. On 2/19 woke up just before midnight with delirium according to partner. Disorientation lasted about an hour.
61 2021-02-19 impaired work ability Day one after second shot: morning only: nausea (Mild and only lasted an hour or so); all day: Head... Read more
Day one after second shot: morning only: nausea (Mild and only lasted an hour or so); all day: Headache, joint pain, chills, tired, (moderate) Arm at injection site swollen, red and hot. Had to work in the afternoon other wise would have taken the day off. Chills came and went all morning and evening. Joint pain came and when, Headache was all the time. Took Tylenol when had to go to work. Day two after second shot: Headache (moderate), Tired/fatigue (moderate) did not go in to work. Arm/Injection site, swollen, red and hot. Day three after second shot: reported on V-Safe.
61 2021-02-21 restlessness, insomnia Awakened by very painful left arm (7 on 1-10 scale), headache (3-4), general discomfort and restless... Read more
Awakened by very painful left arm (7 on 1-10 scale), headache (3-4), general discomfort and restlessness. Within one hour, progressed to bone-rattling, teeth-chattering chills and inability to get warm for several hours, neck and low back pain (7-8), general intense fatigue but inability to sleep because of other discomforts. Over-the-counter Tylenol and a warm magnesium bath temporarily diminished symptoms, but relief was short-lived. Symptoms progressed in early afternoon to diarrhea for about 2 hours and increased fatigue, temperature up to 100.2 (my normal 97.6), headache pain progressed to 4-5, neck and low back remained 7-8. Tylenol seemed to have no effect. Evening (5pm) brought nausea and increased overall discomfort, fatigue, and pain. Aspirin - no effect. At 11:30 p.m. I took Motrin 600 mg and was then able to doze off and on. Throughout I remained very thirsty and consumed many glasses of water and herbal tea. Awoke at 3:45 a.m. 2/22 with only very slight headache, no nausea. Slept soundly until 6:30 a.m. Some fatigue persists, with left-sided pain (5-6) in neck and low back. Left arm remains sore (3-4). No great appetite, but no nausea
61 2021-02-23 hallucination Per patient, she received her vaccine on 02/08/21 and approximately 24 hours later on 02/09/21, she ... Read more
Per patient, she received her vaccine on 02/08/21 and approximately 24 hours later on 02/09/21, she started hallucinating. Patient denied any other symptoms or events. Patient stated that the hallucinations last about 4-6 hours and then went away. She has not had any other symptoms or hallucinations following this.
61 2021-02-25 emotional distress 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 2021-02-25 sleep disorder I had a sore arm at injection site for 3 days, no change in my activity level. On 2/25/2021 my arm b... Read more
I had a sore arm at injection site for 3 days, no change in my activity level. On 2/25/2021 my arm became itchy and began to swell. By evening when I was able to examine the arm the deltoid was swollen to twice it's normal size and a red diffuse itchy rash approximately 4cm by 6cm. I took zyrtec and applied ice. Swelling went down somewhat and itching relieved. 2/26/2021 swelling and itching continued. I iced at 1pm to get some relief. 7:30 feel really run down. will need to ice again to be able to get sleep. I am concerned that a delayed histamine reaction like this may get worse after the next dosage.
61 2021-02-27 confusional state, impaired work ability, feeling abnormal, mental status changes I just wanted to report this interesting side effect. I had very noticable brain fog / confusion the... Read more
I just wanted to report this interesting side effect. I had very noticable brain fog / confusion the following morning, 2/26/21 that lasted only a few hours. I could not function well at work - had trouble problem solving and doing my job working on the phone and computer, making mistakes and communicating poorly. Really, no other side effects. I have been fine since.
61 2021-02-27 insomnia Day of vaccine, Became very flushed within an hour, lasting til bedtime. Flushed face returned the n... Read more
Day of vaccine, Became very flushed within an hour, lasting til bedtime. Flushed face returned the next day also. Left arm became surprisingly sore and painful to move that first evening. During the night entire body became very sore and aching, lasting through second day. Was unable to sleep once the pain started. Second day still flushed, sore arm, achy body and very tired.
61 2021-02-27 sleep disorder Vaccine was incorrectly administered into the shoulder joint, not IM into muscle. Felt the needle h... Read more
Vaccine was incorrectly administered into the shoulder joint, not IM into muscle. Felt the needle hit bone (?). Immediately sore. 3 hours later could not raise arm above waist. Could not sleep. Pain 10/10
61 2021-02-27 sleep disorder 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 disturbance in attention Chills, aches, pain in joints, stabbing pains in my head along with the aching, some nausea, poor co... Read more
Chills, aches, pain in joints, stabbing pains in my head along with the aching, some nausea, poor concentration, site was not clear
61 2021-02-28 feeling abnormal 2/2/2021 8:15 vaccination By 10PM, fever of 100.7. When woke up, my temp was around 103.7. I felt ho... Read more
2/2/2021 8:15 vaccination By 10PM, fever of 100.7. When woke up, my temp was around 103.7. I felt horrible. Took motrin, went back to bed. Took Motrin prior to vaccine and took every 5 hours till i went to bed and still woke up with that fever. Extreme fatigue, lymph nodes swollen under right arm; lasted about 2-2.5 days. Temp lasted approximately 4-4.5 days. *COVID + 10/2020; temp lasted for 14 days.
61 2021-03-04 anxiety PT C/O DIZZINESS AND ANXIETY FROM RECEIVING THE VACCINATION. 1ST BP 192/89 SpO2 99% 2ND BP 166/87 ... Read more
PT C/O DIZZINESS AND ANXIETY FROM RECEIVING THE VACCINATION. 1ST BP 192/89 SpO2 99% 2ND BP 166/87 HR 66
61 2021-03-05 excessive sleepiness At Approximately 2:00 p.m on the day of injection, I Had extreme muscle and joint fatigue, migraine,... Read more
At Approximately 2:00 p.m on the day of injection, I Had extreme muscle and joint fatigue, migraine, body aches, and fever. I slept 10-12 hours.
61 2021-03-06 feeling abnormal Tuesday March 2nd, Swollen arm with a raised rash (my arm was the size of a softball) rash went almo... Read more
Tuesday March 2nd, Swollen arm with a raised rash (my arm was the size of a softball) rash went almost the to my elbow. I had cold chills (ran no fever), dizzy, light headed, woozy, runny nose, eyes ached, head ached, muscle on left side of my neck sore also my gland under my jaw hurt, I was so tired and as the day went on I felt worse . When I went to bed, it felt like I had a softball size knot under my skim in between my arm pit and under arm (left side). There was a short time with my asthma, used my inhaler and it seemed to help. Wednesday March 3rd, Woke up and I was woozy all day and just didn't feel right. I did not feel as bad as the day or evening before, just tired. My left arm still swollen and rash. Not at all the systems the day before. Thursday March 4th, I just didn't feel right. My left arm still swollen with the rash. I felt so much better than the 2 days before. Friday March 5th back to almost normal. Swelling had went down some but still had the rash. Saturday March 6th I felt normal, My left arm swelling went back down and still had a rash. Sunday March 7th swelling gone and I just have a small amount of rash on the sides of my left arm.
61 2021-03-07 depressed mood, depression Sore arm; unexplained deep sadness/depression...lasted two days.
61 2021-03-07 loss of personal independence in daily activities 10 days of muscle and joint pain. Extreme difficulty with perform daily activities.
61 2021-03-08 excessive sleepiness, sleep disorder 12 hours after receiving the shot at approx 3:30 am I woke up with aching pain throughout my entire ... Read more
12 hours after receiving the shot at approx 3:30 am I woke up with aching pain throughout my entire body and intense headache that persisted the entire next day. The 2nd day was 50% improved. Ibuprofen didn't help. Couldn't sleep for a couple of nights, aches diminished and then started sleeping 10 hours a night which is not typical. Extreme fatigue and muscle weakness persisted for 10 days and was gone by day 11.
61 2021-03-08 impaired work ability Malaise, fever, missed work
61 2021-03-08 sleep disorder, impaired work ability 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 2021-03-08 sleep disorder By early the next morning, my mouth started developing sores & my tongue became increasingly swollen... Read more
By early the next morning, my mouth started developing sores & my tongue became increasingly swollen. I had a sore throat for about 15 days; at about one week past this dose, my right shoulder froze & the rotator joint was swollen & incredibly painful to the touch. I lost the use of my right arm entirely for about five days, then the swelling & pain slowly subsided. My eyes were burning & my arm was weak but I made a full recovery about 18 days after this dose. The last symptoms were severe headaches, accompanied by an inability to remain asleep. I took Tylenol & Tylenol PM to alleviate pain & regain some sleep & did report these symptoms to my doctor.
61 2021-03-12 emotional distress, nervousness, anxiety While in observation following vaccination, at 12:05pm patient reported symptoms of anxiousness/nerv... Read more
While in observation following vaccination, at 12:05pm patient reported symptoms of anxiousness/nervousness, light-headedness, and appeared to be emotionally distressed. Patient's legs were elevated, O2 administered via non-rebreather mask 10 LPM, pulse ox 100% and pulse 65 bpm. Patient's symptoms resolved around 12:20pm and patient left without further issues.
61 2021-03-12 impaired work ability Woke up at 3am on 3/7/21 with Chills and Cold Sweet, Fever 98.8, Body Ache, Muscle aches, could not ... Read more
Woke up at 3am on 3/7/21 with Chills and Cold Sweet, Fever 98.8, Body Ache, Muscle aches, could not move because everything ached Had to stay in bed all day and sleep on and off as the fever occurred. Took Tylenol every 4 hours. Was not hungry at all. Woke up the next day at 6:30am with a fever of 99.4 took Tylenol and went back to sleep until noon and woke up feeling much better for the first time. Then kept feeling better as the day went on. Continued to take Tylenol. Friday morning woke up feel great and was able to work since Tuesday that I took the vaccine
61 2021-03-12 impaired work ability 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 2021-03-12 impaired work ability 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 sleep disorder 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 2021-03-15 confusional state After 15minute observation after Moderna vaccine #1. waited15minutes after the Covid 19 vaccine - I... Read more
After 15minute observation after Moderna vaccine #1. waited15minutes after the Covid 19 vaccine - I had shortness of breath, great difficulty breathing, and had to stop and lean on cart, as I was breathing very hard, and nearly couldn't breathe. I had confusion, reporting? Epipen? Tell anyone. I was not aware of my surroundings otherwise during the episode. Afterwards, I was breathing ok? and went home. I later called Moderna, and reported this issue. I called the pharmacist, and reported the problem. I called many other pharmacies, asking for advise - ranging from NO do not take the 2nd vaccine (matter of life/death) due to serious reaction to take it & wait longer.
61 2021-03-16 anxiety ANXIETY
61 2021-03-17 anxiety 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 sensation of foreign body Patient said her fingers started tingling immediately then spread up her arms. Also noted her throat... Read more
Patient said her fingers started tingling immediately then spread up her arms. Also noted her throat felt itchy and swollen ("lump in my throat")
61 2021-03-20 sleep disorder When I received my vaccination the nurse mentioned there was a little blood. One week to the day I... Read more
When I received my vaccination the nurse mentioned there was a little blood. One week to the day I started experiencing an itch around the injection sight. I was woken a few times thru the evening itching my arm. In the morning the area of my arm that received the injection was warm to touch, swollen and it looked like I was punched in the arm. The red bruise that appeared was round and the diameter of an orange. This lasted till Monday. I took 1 Benadryl tablet Monday evening and went to sleep Woke up Tuesday morning and the redness, itch and swelling were gone
61 2021-03-21 disturbance in attention, feeling abnormal Felt woozy 5 minutes after vaccine, but that seemed to subside within an hour. For 3 days felt exhau... Read more
Felt woozy 5 minutes after vaccine, but that seemed to subside within an hour. For 3 days felt exhaustion/chills. It has been 10 days and still feeling off. Dizziness and continued brain fog makes it hard to concentrate.
61 2021-03-21 feeling abnormal Injection site redness and pain within 12 hours, lasted about 36 hours and cleared. 8 days later, in... Read more
Injection site redness and pain within 12 hours, lasted about 36 hours and cleared. 8 days later, injection site became red, painful, and itchy, with an overall feeling of being jittery and feeling ?off?.
61 2021-03-21 excessive sleepiness Horrible Headache. I couldn't hold my eyes open for 36 hours. Generally feeling lousy.
61 2021-03-21 sleep disorder 9 days after 2nd vaccination prolonged headache started. On day 9 headache and tiredness, this is da... Read more
9 days after 2nd vaccination prolonged headache started. On day 9 headache and tiredness, this is day 11 and I still have headache. Cant sleep so bad. This is not a migraine per my lifelong migraines, whole head hurts and I cant make it stop, migraine tablets dont touch it. On days 2-4 post second vaccine, had fever, chills and tiredness. That passed, nothing occurred again until day 9. I am now day 11.
61 2021-03-22 nervousness Patient received COVID19 vaccine @ 1411. Pt was waiting in biosafety area when she began complaining... Read more
Patient received COVID19 vaccine @ 1411. Pt was waiting in biosafety area when she began complaining of discomfort. Pt. felt "nervous, dizzy, and shaky". Pt. could neither confirm nor deny difficulty breathing, but expressed a tightness in the throat. Epinephrine IM was administered at 1433. 911 was called. Pt remained responsive. BP 186/98, 99% on RA, RR increased, EMS assumed care of pt who remained conversational and was transported w/ family (sister) present.
61 2021-03-23 feeling abnormal Headache. Joint aches. Fatigue. Felt bad. Sore injection site. Nothing has much taste. Still today
61 2021-03-24 feeling abnormal a) Expected left arm soreness, visable bruising, immediately following vaccination on day 1 b) Feve... Read more
a) Expected left arm soreness, visable bruising, immediately following vaccination on day 1 b) Fever 101.2 body aches and severe headache, the following morning, day 2, nauseous and severe headache with episodes of regurgitation started afternoon of day two c) Headache and abdominal pain persisted and escalated prompting 5 hr ER Visit, offered script for pain and nausea, CAT-scan performed, sent home on day 3. d) abdominal pain increased significantly prompting return to ER evening of day 3, ultrasound of gallbladder with negative results, continued pain management with tordahl. Sent back home. e) abdominal pain, headaches and vomiting persisted for 3 days until it was unmanageable on day 7 prompting Additional information for Item 18: e) continued - Return to the ER on Saturday early morning at which time inflamed colon was identified, provided oxi-pain management, antibiotics and sent me home. f) On day 8 (Sunday), abdominal pain and vomiting with dry heaves persisted, headache improving through Monday. g) Tuesday, late evening called ambulance due to overall miserable suffering, they did not transport thinking I was still relatively stable and talked me out of going to ER. h) Wednesday morning still sever abdominal pain and suffering went to ER where they administered pain medications and admitted me for ongoing pain management. Beds were not available, spend the night and next day in the ER. i) Wednesday the 17th the Gerontologist visited me in hospital, performed endoscopy and revealed Hiayatal-hernia and inflammation, continued pain and nausea medication for four days until discharged on morning of 21.
61 2021-03-24 feeling abnormal Patient have fever of 100.0 - 104.0 / due to not getting the fever controlled; not doing very good; ... Read more
Patient have fever of 100.0 - 104.0 / due to not getting the fever controlled; not doing very good; very weak; A spontaneous report was received from 63-year-old female patient, who received Moderna's COVID-19 vaccine and experienced fever of 100.0 - 104.0/ pyrexia, not doing very good/feeling abnormal, and very weak/asthenia. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 15 Jan 2021, prior to the onset of events, the patient received an unspecified dose of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis. On 16 Feb 2021, after an unspecified dose of vaccine, the patient experienced fever of 100.0 - 104.0, was not doing very good, very weak. On 14 MAR 2021, patient was admitted to the hospital due to uncontrolled fever. No treatment medication was reported. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, fever of 100.0 - 104.0, not doing very good, very weak was ongoing at the time of this report.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the start date of the reported events and excluding any other etiology, a causal relationship with the events cannot be excluded.
61 2021-03-25 anxiety, impaired work ability, sleep disorder Severe headache, chills (97.8 temp), muscle and joint aches, sensitive skin, exhaustion commencing 8... Read more
Severe headache, chills (97.8 temp), muscle and joint aches, sensitive skin, exhaustion commencing 8 hours post vaccination and continuing for approximately 30 hours. Despite exhaustion, unable to sleep due an anxious feeling. Headache and muscle and joint pain subsided but an inability to control body temperature continued but still never a fever. Developed a scratchy throat and dry cough. Continued lack of energy. Unable to work or do physical exercise. A feeling of coming down with a bad cold, but no cold. The dry cough lasting 8 days to date (3/26/7/21). Went to GP, no sign of infection or upper respiratory infection. Suspects that all symptoms are a result of vaccine #2. Did have slight rash on left upper arm at vaccine sight that started approximately 48 hours following shot and lasting approximately 3 days. On day 15, still feeling quite ill. Not much relief from Tylenol.
61 2021-03-25 feeling abnormal Facial numbness, swelling and hives all over neck. Brain fog. The symptoms left on March 25th. F... Read more
Facial numbness, swelling and hives all over neck. Brain fog. The symptoms left on March 25th. Facial numbness & brain fog have returned today March 26th
61 2021-03-25 sleep disorder 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 sleep disorder Had Covid arm for a few days after both 1st & 2nd doses. After 2nd dose, had headache and fever the ... Read more
Had Covid arm for a few days after both 1st & 2nd doses. After 2nd dose, had headache and fever the next day for a few hours & felt somewhat weak & tired. Took a Tylenol the day after in the evening & the fever & headache went away after 30 minutes. 10 days later, on Wed 3/24, began having rashes on both arms around the inside elbow area & also upper arm. Very itchy & got larger, although tried not to itch. First 1 arm, then the other, This woke me at 3:30 am. Then, bottom of left foot on the side got a 2" red area that started itching also. Then yesterday, a larger area on the right foot. These all subsided after maybe 2 hrs.. They keep coming back again, one after the other,very itchy. Looks like poison ivy almost & 2 on the arms had blisters. I feel hot occasionally, but no fever
61 2021-03-27 depression Experienced anaphylactic shock 4.5 mins after given 30 min timer. Developed severe red splotchy rash... Read more
Experienced anaphylactic shock 4.5 mins after given 30 min timer. Developed severe red splotchy rash around neck. Arm remained super sore for a week, then developed a huge red whelp the size of my hand with constant itching & burning (resembled a reaction to a hornet sting & I am NOT allergic). The whelp disappeared but itching & burning finally went away into 3rd week. Developed severe depression 2 days afterwards that lasted approximately 5 days.
61 2021-03-28 disturbance in attention, feeling abnormal Extreme muscle aches, Headache, Alot of Trouble Focusing on anything, bones and muscle feel extreme ... Read more
Extreme muscle aches, Headache, Alot of Trouble Focusing on anything, bones and muscle feel extreme fatigue. Feel out of it like I'm walking around exhausted and not really here in the present. Brain very foggy.
61 2021-03-28 feeling abnormal 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 insomnia patient began having pain in vaccinated arm that caused discomfort and difficulty sleeping. This sta... Read more
patient began having pain in vaccinated arm that caused discomfort and difficulty sleeping. This started on 2/25 and only occurred between the hours of 7pm - 7am. Patient was still able to fall asleep, but was concerned about the feeling. She states that "she felt like she got the vaccine all over again". Symptoms went away after the fourth day and have not returned. She did not treat with any OTC / RX medications.
61 2021-03-29 agitation 12 minutes after receiving dose, numbness and tingling in face and nose 15 minutes after receiving d... Read more
12 minutes after receiving dose, numbness and tingling in face and nose 15 minutes after receiving dose, red rash evident on face and patient highly agitated 75 -90 minutes all symptoms increased in intensity and rash spread to cover face and nose
61 2021-03-29 agitation Very sore at injection site Weakness muscle and joint aches very agitated
61 2021-03-29 disturbance in attention, sleep disorder Felt nauseous then saw stars within 15 minutes. Went home and ran fever 101.3 for 2 days. Couldn?t m... Read more
Felt nauseous then saw stars within 15 minutes. Went home and ran fever 101.3 for 2 days. Couldn?t move from couch. Very tired times one week. Then profuse sweating two nights. And now having blood sugar issues where I crash and need to be careful to eat carefully and sleep extra. With caution I don?t see stars but still not sleeping well. Mood. Concentration. Sight. All affected during episodes.
61 2021-03-29 disturbance in attention Nausea 12 hours later followed by vomiting. Extreme fatigue. Unable to concentrate or stay awake fo... Read more
Nausea 12 hours later followed by vomiting. Extreme fatigue. Unable to concentrate or stay awake for 24 hours after reaction started. Mild fatigue lasted for 5 days
61 2021-03-30 feeling abnormal Nausea, headache, body ache, chills, flushed, fatigue, brain fog
61 2021-03-31 confusional state, feeling abnormal Pt reported feeling dizzy immediately post first dose of Moderna vaccine. Feeling "hot, dizzy & fogg... Read more
Pt reported feeling dizzy immediately post first dose of Moderna vaccine. Feeling "hot, dizzy & foggy" 2:55p.m. BP 130/92 HR 104 RR 22 94% 02 sat. On assessment alert and talking, intermittent confusion noted with blank stares, difficulty finding words progressively getting worse. EMS activated @ 3:05pm. Finger stick 155. BP 136/86 HR 101 02 sat 97%. Remained alert, intermittent confusion continued. Refused EMS transport to hospital for evaluation. Patient and husband instructed to call 911 if patient not feeling well or worse/ altered mental state not improving. Ambulated out of clinic with husband. AMA.
61 2021-03-31 sensation of foreign body 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 sleep disorder Pain started in left arm then started moving up to neck, headache, down back , hip, leg, feet , comp... Read more
Pain started in left arm then started moving up to neck, headache, down back , hip, leg, feet , complete soreness mainly on left side , thirst , very tired couldn?t sleep during the night 03/30, then felt exhausted and slept most of the day and pain continued 03/31. Slept all night 3/31. Took Motrin to help with pain .
61 2021-04-01 feeling abnormal dizziness, blurred vision, ear ringing, ear pressure, fatigue/malaise, mild headache, sluggishness, ... Read more
dizziness, blurred vision, ear ringing, ear pressure, fatigue/malaise, mild headache, sluggishness, brain fog, difficulty speaking, joint pain, symptoms from 8 hours after vaccination until 48 hours after vaccination
61 2021-04-01 loss of personal independence in daily activities One day after being vaccinated, dull headache (anticipated that) but got a progressively worse pain ... Read more
One day after being vaccinated, dull headache (anticipated that) but got a progressively worse pain in my left hip (only). I've never had hip pain. Standing was fine. Getting up from a sitting position was excruciating. Difficulty getting into my Jeep (could not raise left leg), and excruciating pain getting out of the Jeep. Could not bend to pick up anything, could not put on socks, painful rolling over in bed. This lasted 3 full days. It got a little better each day after that. Today (3 weeks later) my hip is 95% back to normal. I had not done any heavy lifting, etc. to have caused an injury to my hip. No other joint pain whatsoever. Just left hip affected.
61 2021-04-01 nervousness Patient alerted pharmacy that she had experienced swelling and itching from influenza shots in the p... Read more
Patient alerted pharmacy that she had experienced swelling and itching from influenza shots in the past, and has asthma and allergies, however has never had to use an Epi-pen in the past. Patient seemed very nervous, but insisted she was OK to receive the shot. Pharmacist on duty administered Moderna to patient, and waited next to her for several minutes to observe for possible reaction. Patient felt fine after several minutes of talking, so pharmacist advised patient and her husband to let her know if patient started feeling SOB, or itchy, or swelling of face, and went back to pharmacy to complete rxs in que. At that time a different patient who had just received the Moderna vaccine passed out, and pt witnessed this, further increasing her anxiety. 911 was called for the patient who passed out. During the next half hour, pharmacist kept checking on pt. She indicated her tongue seemed to be swelling. So pharmacist on duty asked EMT to check out pt after they had finished taking care of patient who had passed out. EMT checked pt throat, and assured her there was no swelling, however suggested diphenhydramine 25-50mg to be proactive. Pharmacist on duty asked pt if she would like diphenhydramine, and she said, "Yes, Please." So pharmacist provided the diphenhydramine to pt, and she took 50mg. After that she seemed to be fine, and her husband took her home.
61 2021-04-01 nightmare, impaired work ability Teeth chattering chills Low grade fever Headache Body & Joint Pain Extreme Fatigue Bad Dreams Sta... Read more
Teeth chattering chills Low grade fever Headache Body & Joint Pain Extreme Fatigue Bad Dreams Started about 12 hrs after vaccine Lasted 24 -34 hours. Had to miss work 1 day. Felt totally fine afterwards.
61 2021-04-01 sleep disorder She got her vaccine, and had the body aches that were all over. Then she had headaches that started... Read more
She got her vaccine, and had the body aches that were all over. Then she had headaches that started, not as bad as the COVID headache, but was bad. She fell back to sleep and had chills, took her temp and it was 101. She fell back to sleep and woke back up at 6:00 AM and her temp was 103.3, and took Tylenol and got it down to 102.7. She then had uncontrollable chills with shivering and her temp stayed at 103. Then she got it down during the day, and was alternating between 101-103 throughout the day. That night when she went to sleep around midnight it was 101. It broke during the night and she then got a cough which lasted all day, and had it yesterday as well, and woke up today with everything was completely gone. These symptoms were worse than when she had COVID back in February/March.
61 2021-04-02 feeling abnormal 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 2021-04-02 loss of personal independence in daily activities Day 8, sore eyes, chills, debilitating fatigue, nausea, dizzy, fever, unable to function for 8 days
61 2021-04-04 feeling abnormal painful sore lump with redness/rash on the 7th day The redness rash got bigger for 3 days and the pa... Read more
painful sore lump with redness/rash on the 7th day The redness rash got bigger for 3 days and the pain was bad enough I could not raise my arm I felt fatigued and mentally unable to focus for 4 days after the 7th day.
61 2021-04-04 nervousness, feeling abnormal 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 2021-04-04 sleep disorder Circular rash on left arm at vaccine site. First noticed morning of Day 14 since shot. Did not sleep... Read more
Circular rash on left arm at vaccine site. First noticed morning of Day 14 since shot. Did not sleep well prior night. No pain or itching at site so far.
61 2021-04-05 anxiety Patient presenting with complaint of roof of mouth and tongue tingling. Provider assessed patient Or... Read more
Patient presenting with complaint of roof of mouth and tongue tingling. Provider assessed patient Ordered Benadryl 25mg PO at 10:23 Vital Signs at 10:22 BP: 136/80 HR:78 RR:18 02:98% Provider notes state anxiety related, no cranial nerve, sensory motor deficit. Patient monitored for 30 min. Symptoms improved advised to go to ER if symptoms worsen.
61 2021-04-05 sleep disorder After getting the shot Friday morning, I felt sluggish all day, I went to bed early and woke up at ... Read more
After getting the shot Friday morning, I felt sluggish all day, I went to bed early and woke up at about 2 am Saturday with joint pain on every joint in my body from my neck to my ankles. I could hardly get out of bed because my knees were so stiff. My hands were stiff and I couldn?t open and close them without pain. It has been like that every day since. I?ve been unable to sleep and trying to turn over in bed is excruciating . I have been taking Xtra strength Tylenol and that helps for about 2-3 hours
61 2021-04-06 feeling abnormal She got the vaccine, and then had headache, fever and slight fatigue. No she has welts all over her... Read more
She got the vaccine, and then had headache, fever and slight fatigue. No she has welts all over her body, very itchy, they get warm to the touch and it started in a couple of spots and now are everywhere. When she wakes up she gets more, and feels like she's in a horror movie. Notified her doctor and he wants her to take Benadryl at night and using Benadryl cream, but it's not completely alleviating the symptoms. The patient states that she is miserable.
61 2021-04-06 excessive sleepiness Massive headache. Body aches. 102 fever. Hurt to walk. Touching skin pain. Very tired.. slept 18 ho... Read more
Massive headache. Body aches. 102 fever. Hurt to walk. Touching skin pain. Very tired.. slept 18 hours. 4/2/21 . 4/3/21 still had previous symptoms but not as severe. Note: had covid in October 2020. Hospitalized 4 days only. Still feel certain effects of that.
61 2021-04-07 feeling abnormal 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 2021-04-07 loss of personal independence in daily activities Two days after the shot, I woke up with severe left-sided (same arm as shot) neck, upper back and w... Read more
Two days after the shot, I woke up with severe left-sided (same arm as shot) neck, upper back and whole arm pain. It has lasted for two weeks now. Nothing seems to help the pain. Heat seems to help some. But I cannot do activities of daily living without pain. I have been to a chiropractor besides my Primary Care Dr. Not absolutely sure if it is from the shot but could be a contributing factor.
61 2021-04-07 sleep disorder Upper arm (at injection site) gradually became itchy starting 3 days after vaccine injection. By the... Read more
Upper arm (at injection site) gradually became itchy starting 3 days after vaccine injection. By the 6th day after injection it was constantly itchy. It woke me up in the night. No rash, just itch.
61 2021-04-08 confusional state 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 feeling abnormal, mental impairment 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 feeling abnormal The day after the shot: Fatigue, shortness of breath, pain at injection site, dizziness, foggy brai... Read more
The day after the shot: Fatigue, shortness of breath, pain at injection site, dizziness, foggy brain.
61 2021-04-08 feeling abnormal Patient states that when she woke up on Friday morning around 5:30 am she had developed a single wel... Read more
Patient states that when she woke up on Friday morning around 5:30 am she had developed a single welt on her neck and face and a rash around the welt. She also had chills that started April 3rd. Tuesday April 6th, she developed a feeling like she was floating and, she felt off - like in a mind fog and sensation lasted for about 20 minutes and it has not returned since.
61 2021-04-08 impaired work ability Fever, chills, extreme fatigue, general malaise, extreme weakness, nausea, loss of appetite, headach... Read more
Fever, chills, extreme fatigue, general malaise, extreme weakness, nausea, loss of appetite, headache, body aches all over. I became ill the night I took the shot. I stayed in bed for 36 hours without eating and could not work. I was totally exhausted. After the 36 hours, I slowly recovered. I had received the shot (first dose of Moderna) on Thursday at about Noon. I was not able to return to work until Monday afternoon, and it was very limited on Monday. (I own my own business and had canceled work and clients and office work). I was back to about 75 % normal capacity to work on Tuesday, and close to 100 % on Wednesday.
61 2021-04-08 sleep disorder, loss of personal independence in daily activities, impaired work ability Severe headache, muscle and joint pain, dizziness, weakness, exhaustion, chills (no fever), nausea, ... Read more
Severe headache, muscle and joint pain, dizziness, weakness, exhaustion, chills (no fever), nausea, skin painful to the touch. Severe dry cough, unable to sleep. Symptoms lasting 4 weeks this far. Unable to work and conduct normal daily activities from 3/12/21 to 4/9/21, so far.
61 2021-04-08 sleep disorder Received 2nd Covid19 Moderna vaccine on April 6 in left arm. Very hard rock-like lump area appeare... Read more
Received 2nd Covid19 Moderna vaccine on April 6 in left arm. Very hard rock-like lump area appeared within a couple hrs. By next day large red area around injection site. Painful to touch, and very itchy. Could not sleep on left side. FYI received first Covid19 Moderna vaccine on March 9. Arm slightly sore for couple days, but no other reaction, no redness or itching.
61 2021-04-09 feeling abnormal, disturbance in attention That evening I had a red rash on my left arm below the injection site. My left underarm lymph node ... Read more
That evening I had a red rash on my left arm below the injection site. My left underarm lymph node became swollen. The following day I had brain fog. Had a hard time concentrating on work and a headache. The rash on my arm faded after several days and then returned on day 9. The rash took another week to fade away. My lymph node under my left arm is still visibly swollen and it has been 3.5 weeks since the injection. I went to see my primary care doctor who examined me and suggested I get the second vaccine in the right arm since the lymph node is still swollen. I went to the dentist 7 days after the vaccine and the hygienist advised that my left neck glad was also swollen. I am concern about getting the second vaccine with the lymph node still being swollen.
61 2021-04-09 feeling abnormal Again like the first dose, I felt burning sensation in my chest half hour. As day progressed, I felt... Read more
Again like the first dose, I felt burning sensation in my chest half hour. As day progressed, I felt worse. Intermittent muscle spasms all over my body, thighs, back, arms, chest area, bad headaches, muscle aches, joint pain, chills.
61 2021-04-10 feeling abnormal 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 2021-04-10 insomnia My arm was sore first day of shot. Every day I had many side effects ,nausea, diarrhea, headache, ac... Read more
My arm was sore first day of shot. Every day I had many side effects ,nausea, diarrhea, headache, achy, fever, sinus drainage, trouble sleeping.i was ok with dayquil,nyquil
61 2021-04-11 disorientation, impaired work ability Site pain and swelling, body pain, dizziness, chills, slight fever, headache, nausea, vomiting, diar... Read more
Site pain and swelling, body pain, dizziness, chills, slight fever, headache, nausea, vomiting, diarrhea, fatigue, disoriented, cannot work. On third day of this.
61 2021-04-11 feeling abnormal I had a terrible headache and fever from 6:00am on 4/8 until 4:00am on 4/9. 101.4 with Tylenol and ... Read more
I had a terrible headache and fever from 6:00am on 4/8 until 4:00am on 4/9. 101.4 with Tylenol and Advil alternating every 2 hours. Severe body aches, severe fatigue. It was incredible how terrible I felt. At 4:00am on 4/9 I miraculously felt fine! With the 1st injection I had a severe headache for 3 days. I do not get headaches any more since I made lifestyle changes. (I used to get migraines) I have been an RN for over 40 yrs. I am glad I got the vaccine but BOY was the second one tough!
61 2021-04-11 sleep disorder Moderate joint pain in knees, preventing sleeping and normal movement, onset 24 hours hours post-vac... Read more
Moderate joint pain in knees, preventing sleeping and normal movement, onset 24 hours hours post-vaccination, resolved 60 hours post-vaccination Headache onset 24 hours post-vaccination, resolved 48 hours post-vaccination Fatigue and chills onset 24 hours post-vaccination, resolved 48 hours post-vaccination
61 2021-04-12 euphoric mood, feeling abnormal 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 mental impairment Severe head aches severe body aches Severe metal and physical fatigue Fever Loss of appetite Prob... Read more
Severe head aches severe body aches Severe metal and physical fatigue Fever Loss of appetite Problems thinking clearly
61 2021-04-13 feeling abnormal 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 restlessness Received first does on 3-14-21 at 4:00 p.m. No adverse effects. Received second dose on 4-11-21 at 3... Read more
Received first does on 3-14-21 at 4:00 p.m. No adverse effects. Received second dose on 4-11-21 at 3:00 p.m. Well hydrated the day before. Woke about 2:00 a.m. due to pain in injection site. Took one Tylenol tab. Restless light sleep for about 4 hours. Some chills. Woke about 5:00 a.m. Ate light breakfast. Developed low grade fever (99) for several hours. Took second Tylenol tab. Fatigue, Lack of appetite. Sore injection site. Slept 2.5 hours. Lethargic rest of the day. Didn't eat much. To bed early. 4-12-21 Considerably better. Although developed metal taste in mouth all day. 4-13-21 Feel normal and metallic taste gone.
61 2021-04-14 confusional state 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 impaired work ability, disturbance in attention Hot and cold sweats all night, severe joint and muscle pain, very fatigued, did not get up all day e... Read more
Hot and cold sweats all night, severe joint and muscle pain, very fatigued, did not get up all day except to urinate. It was like the worst flu ever! 4/15/21: extreme fatigue and dizziness upon getting up to walk or moving my head. Unable to concentrate on computer screen to work. but, pain and hot/cold sweats gone.
61 2021-04-14 impaired work ability Within 12 hours I had fever, chills and a severe headache along with fatigue. The headache and fatig... Read more
Within 12 hours I had fever, chills and a severe headache along with fatigue. The headache and fatigue have stayed with me since the injection 10 weeks ago. I have been out of work for 3 weeks due to the increasing fatigue. I am now on medication to help control that.
61 2021-04-14 panic attack 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 sleep disorder Two days after taking the 1st vaccination, I developed a cough. As the days have passed, the cough g... Read more
Two days after taking the 1st vaccination, I developed a cough. As the days have passed, the cough got worse and has leveled off to a lingering productive cough with a dull ache on the left side of my back. I have suffered from pneumonia several times in my life and this feels similar to the early stages, however, I have no other symptoms and have nor felt as though I had an elevated temperature. I work as a technical support rep and have to talk on the phone eight hours a day and I have found it difficult over the last three days to talk for extended periods of time. I get mild shortness of breath and as the day progresses, the coughing gets worse and I am awakened several times during the night coughing.
61 2021-04-15 excessive sleepiness I was sick the whole next day... upset stomach...no energy- slept most of the day,,,headache, even t... Read more
I was sick the whole next day... upset stomach...no energy- slept most of the day,,,headache, even teeth hurt
61 2021-04-17 irritability, depression 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 2021-04-19 panic attack 61y F hx HLD presenting with concern for allergic reaction after Moderna covid-19 vaccine ... Read more
61y F hx HLD presenting with concern for allergic reaction after Moderna covid-19 vaccine - received 1st dose Moderna vaccine on 4/17 at Pharmacy at around 12:40pm states that within 10-12 minutes developed a headache that resolved spontaneously - Then she felt like her throat was sore and tongue was swelling. Difficult to tell if it was hard to breathe because she says she was panicking. When she drank liquid, it made her throat feel better - states her b/l hands swelled and turned purple - went to ED shortly after, received IV benadryl, and all symptoms improved. ED records reviewed- normal examination, including oropharygeal and lung exam. D/c on benadryl only, no epi-pen or steroids - since d/c from ED she has been taking Benadryl 50mg about 3 times day. Last dose this morning - last episode of tongue swelling was yesterday morning. No swelling today but took benadryl as prophylactic
61 2021-04-21 confusional state, feeling abnormal, memory impairment woke up with mild vertigo for four days in a row had problems remembering words, which was obvious a... Read more
woke up with mild vertigo for four days in a row had problems remembering words, which was obvious and not typical felt generalized confusion and foggy in the brain
61 2021-04-21 hallucination headache, drenching night sweats, sleep paralysis, hallucinations: "entities pouring into bedroom an... Read more
headache, drenching night sweats, sleep paralysis, hallucinations: "entities pouring into bedroom and over bed, stuck in a deep crevasse with people trying to pull her out, earthquake"
61 2021-04-21 nervousness, anxiety Felt nervous, anxious, vital WNL.
61 2021-04-22 feeling abnormal received the vac on 4/6, starting aprox 8th -9th I start to not feel good... just thought is was a m... Read more
received the vac on 4/6, starting aprox 8th -9th I start to not feel good... just thought is was a mild reaction to the shot... by the 12th I felt terrible, very short of breath and unable to walk with out thinking I was going to die...... waiting as long as I could then I went to urgent care on the 14th and was told I probably have asthma and was given a few medications... on the 18th things were not any better and I no longer could take the pain and not being able to breathe... so I went to the hospital and was admitted to the PPC floor of the hospital after being in the ER. the next morning I had to have a procedure to break up BLOOD CLOTS in my lungs... I spent 4 days in the PPC ward and now home trying to recover from this... I was told my condition was very serious and was lucky I came in... Of course the doctors will not say this was a direct link to the shot ... i never had any problems before and never any blood clots. The doctor who did the procedure told me to make sure I REPORTED IT.... I was released from the hospital on the afternoon of the 21st.. 4 days!
61 2021-04-23 sleep disorder I got an extremely painful stiff neck on same day as Moderna Shot 2, and was unable to sleep for 3 f... Read more
I got an extremely painful stiff neck on same day as Moderna Shot 2, and was unable to sleep for 3 full days from the intense pain in my neck. I am still having a horrible neck ache over 2 weeks later. Also had bad chills, fever, headache, vomiting, severe muscle aches & pains, severe joint pain. Was ill for 5 days with all symptoms, am still dealing with the intense stiff neck, & severe neck pain.
61 2021-04-24 feeling abnormal I started with cold-like symptoms on Wednesday, April 7, 2021. Coughing, sore throat, low grade feve... Read more
I started with cold-like symptoms on Wednesday, April 7, 2021. Coughing, sore throat, low grade fever 99.7to 100.9, stuffy nose. Fever was off and on for about 4 days. Sore throat didn't last too long. Also very tired and just feeling blah. Coughing and stuffy and now runny nose are still with me today. Also coughing up phlegm. Everytime I think, I am feeling better, I start coughing. A horsey cough. I tried calling the doctor last week, but there was a long wait time and I work at an elementary school, so it was not convenient for me to wait. I think this is lasting extremely long and wonder if it is from the Moderna shot? My husband also had similar symptoms. Let me know if you need any other info.
61 2021-04-24 feeling abnormal Dizziness. Didn't seek medical treatment, but did take Meclizine at the beginning to help the dizzi... Read more
Dizziness. Didn't seek medical treatment, but did take Meclizine at the beginning to help the dizziness. Dizziness started on April 14th in the evening and was present on April 15th. Again on April 16th in the evening and throughout the day on April 17th. Happened again on April 22nd and 23rd. On the days the dizziness wasn't bad, I still felt that things were a little off in my system. I'm finally starting to feel normal again on April 25th. Hopefully the dizziness doesn't return.
61 2021-04-25 abnormal dreams, excessive sleepiness Vomiting fever chills aches headache tired vivid dreams sleeping a lot
61 2021-04-26 anxiety, crying, depression I took all of my medications around 9pm on 4/21/2021 (was fatigued, went to bed early). I woke up on... Read more
I took all of my medications around 9pm on 4/21/2021 (was fatigued, went to bed early). I woke up on 4/22/2021 with continual brain synapse misfirings (brain zaps) which occurs from anti-depressant withdrawal. It's as if the venlafaxine was not absorbed by my body. I became despondent, severely depressed, anxious, cried non-stop with the brain zaps occurring non-stop. I felt as though I was having a nervous breakdown. I went to sleep that evening (took all my medication per usual) and work up the next morning fatigued but the brain zaps were gone and emotionally I was feeling much better.
61 2021-04-26 impaired work ability 3/23/21 1st dose had tingling in my fingers of left arm/injection arm the evening of vaccine and sor... Read more
3/23/21 1st dose had tingling in my fingers of left arm/injection arm the evening of vaccine and sore arm for several days. Nothing that disrupted anything other than sleeping on left arm 4/20/2021 2nd dose chills began evening of vaccine along with tingling fingers. the next day I experienced fatigue, headache , muscle pain, joint pain chills, nausea, loss of appetite, sore left arm with some swelling around injection site. I was not able to work 4/21 and also missed work 4/22 but side effects were much better; not so tired but headache continued. Took Tylenol and headache improved.
61 2021-04-27 anxiety Pt called call center. Pt c/o on/off dizziness since 04/26/2021 and also feeling slight anxious. Pt ... Read more
Pt called call center. Pt c/o on/off dizziness since 04/26/2021 and also feeling slight anxious. Pt also stated she had fever and chills on 04/22/021 after she got covid 19 vaccine Moderna on 04/22 but fever, chills went away and was feeling ok till yesterday. Pt advised to go to urgent care or ED.
61 2021-04-27 feeling abnormal 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 2021-04-27 excessive sleepiness, feeling abnormal Woke up in the middle of the night to use the bathroom the day after receiving 2nd vaccine. I neede... Read more
Woke up in the middle of the night to use the bathroom the day after receiving 2nd vaccine. I needed to turn left to get to the bathroom but turned right instead. Same morning woke up and felt really bad. I could not see right. I could not read my phone. Went back to bed and slept 8+ hours. Was sick feeling on Friday, Saturday and Sunday. Slept a lot!! Had chills. Took my temperature and it was 93 degrees. Could not see correctly for about one week. I usually wear reading glasses but could not as glasses made me really dizzy. I could smell really really well (smelled sour milk about 2 feet away). It was like the vaccine made my senses better. Took about a week before my vision seemed to return back to normal.
61 2021-04-27 sleep disorder Rash and swelling at vaccination site (L ARM) the day after vaccine. Poison Ivy- like rash began 4/1... Read more
Rash and swelling at vaccination site (L ARM) the day after vaccine. Poison Ivy- like rash began 4/19. Bilateral upper and lower extremities. Itchy and painful, pustules, hot to touch. Unable to sleep. Spreading and worsening as of 4/28.
61 2021-04-28 confusional state I became very feverish, 101 degrees, with chills and headache, confusion and very fatigued. I had s... Read more
I became very feverish, 101 degrees, with chills and headache, confusion and very fatigued. I had severe sweating in the early mornings. This lasted for two days. The injection site is hot, inflamed and red. My husband had Covid at the same time as me and received the same first dose of the vaccine at the same time that I did at the same place. His symptoms are exactly the same as mine, his fever was higher at 102 degrees. Today we are feeling a bit better and able to work. Our arms are still inflamed and hot. We are afraid to get the second dose of the vaccine and don't know what to do.
61 2021-04-28 sleep disorder I received my shot at 5:45pm Thursday, 4/22/21 at the High School from Healthcare. Friday morning ... Read more
I received my shot at 5:45pm Thursday, 4/22/21 at the High School from Healthcare. Friday morning I noticed a headache developing around 9am. I laid down to rest at 10:30-12:30pm, when I woke up I had chills, took some acetaminophen, went back to sleep and woke up around 3-4pm, then went back to sleep. I woke up around 6pm and had chills still, took more acetaminophen. I also noticed major body aches through out my body, it was very difficult to move. When I went to bed around 10 I had a fever of 100.3 and took Aleve. I woke up around 1:30am Sat when my fever broke. Saturday I got up around 9am and was feeling better but my right arm was grossly swollen, very hot and painful. I took Aspirin, then later took Acetaminophen again and also wrapped an ice pack around my arm. The redness and swelling traveled down my arm for the following 5 days along with itchiness. I got a migraine on Wed, today Thursday. Swelling is now gone and redness gone.
61 2021-04-29 feeling abnormal Headache, pain, sour throat, hot, chills, misery for 2 days. Now, 2 weeks later still have a persis... Read more
Headache, pain, sour throat, hot, chills, misery for 2 days. Now, 2 weeks later still have a persistent cough. Dry, constant.
61 2021-05-03 sleep disorder On the day of - after few hours felt little bit of internal prickly sensation in the forearm area no... Read more
On the day of - after few hours felt little bit of internal prickly sensation in the forearm area no other redness or swelling in the arm at all. On the 2nd day after the shot (5/3/21), woke up with Severe swelling in the upper arm the shot area, redness and swelling spread up to 7" below the shot area (7+" down and 4+"wide area) and continues to exist. Couldn't fall asleep that night until 3am of next day (no pain except for swelling sensation). No other symptoms to report at this time. Just reporting for research data
61 2021-05-04 anxiety 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 2021-05-04 insomnia ringing in ears, migraines, pain in ears-worse after second vaccine. continuing, nauseous loud noise... Read more
ringing in ears, migraines, pain in ears-worse after second vaccine. continuing, nauseous loud noises, sounds bad hurt. sleep horrible. lifechanging worse after 2nd vaccine. and continuing worse on left side that shot was given on. First time right arm
61 2021-05-04 memory impairment, feeling abnormal Ringing in my ears (which I have had for many years at a LOW and TOLERABLE level - I would only occa... Read more
Ringing in my ears (which I have had for many years at a LOW and TOLERABLE level - I would only occasionally notice it, maybe once or twice a month) became louder and impossible to tune out. I have had constant LOUD high pitched ringing in my ears DAILY for almost four weeks now, and it has not decreased in volume. I also have brain fog and am very forgetful (not a normal characteristic of me).
61 2021-05-09 feeling abnormal After the 1st dose, I had a headache for 3 days that gradually decresed. I took Tylenol. After the 2... Read more
After the 1st dose, I had a headache for 3 days that gradually decresed. I took Tylenol. After the 2nd dose, I had "brain fog", tireness tireness, and occasional headache for 4 days. The brain fog diminished but the tiredness increased where I have to take 30-60 minutes naps periodically sometimes 2-3 times during the day. Week of 5/3/21, I have diarrhea. I take Tylenol, drink Pedialyte, and increased my water intake. The tiredness interferes with my work and home life.
61 2021-05-11 sleep disorder Day 1 dizziness, mild headache, could not get warm, no fever, diarrhea, extreme nausea, severely in... Read more
Day 1 dizziness, mild headache, could not get warm, no fever, diarrhea, extreme nausea, severely increased ringing of left ear. Day 2 same as day 1, day 3 - day 8 dehydration and sever ringing of ears. Day 9 sudden diminished hearing in the left ear. Ringing and hearing loss remain today 5/12/21. I saw my regular physician, an ENT PA, and Audiologist. Took hearing test which confirmed loss of hearing in left ear (compared to previous test; right ear was the same). Took 10 mg of Prednisone for 10 days to regain hearing, did not improve (2nd hearing test), had an MRI, no significant finding. I am now taking sleeping aids.
61 2021-05-11 sleep disorder L arm pain causing difficulty sleeping; unable to use arm for simple tasks; pain radiating to elbow,... Read more
L arm pain causing difficulty sleeping; unable to use arm for simple tasks; pain radiating to elbow, shoulder and neck (L side)
61 2021-05-13 feeling abnormal 24 hours after 2nd vaccine on 4/29 had typical reaction, foggy head, head ache, chills, body ache, f... Read more
24 hours after 2nd vaccine on 4/29 had typical reaction, foggy head, head ache, chills, body ache, fatigue 36 hours after 2nd vaccine on 5/30 had very painful constant and unrelenting stomach cramps for a solid 7 hours 48 hours after had unusual skin pain on torso area off and on for 2-3 days 10 days after vaccine developed first stages of shingles with significant pain in upper back and torso, mostly on left side 12 days after shingles rash appeared on upper left back, side and chest, lymph nodes in arm pits swollen and tender 15 days after full blown case of shingles with large rash and significant pain in left torso area
61 2021-05-14 feeling abnormal Louder Tinnitus, brain fog. Started the next morning. Itchy rash at injection site one week later. G... Read more
Louder Tinnitus, brain fog. Started the next morning. Itchy rash at injection site one week later. Gone by time to see Dr.. Called to ask about appointment, it was agreed, no more need to go at that time. Tinnitus settled down a little before second dose. After second dose tinnitus has become much worse. It goes from loud to louder. I do know how to live with my tinnitus. This is Much worse than when I first started to have it. Brain fog comes and goes. Has not improved. Dizziness (vertigo?) has to be added now too. Have needed to sit down several times now, this is not normal for me. Feet and hands will feel as if I wearing thick gloves. Comes and goes.
61 2021-05-14 loss of personal independence in daily activities Within the first week after the vaccine, I began to get zapping electrical-like pains in the nerves ... Read more
Within the first week after the vaccine, I began to get zapping electrical-like pains in the nerves in my fingertips and heels of my feet. I developed sharp twitching of my limbs, fingers, and one night, even my tongue. A mild tremor that I had been feeling since a prior medication reaction (Tamoxifen) suddenly escalated. Over the next week, the tremor began to have the same electrical quality in my upper arms and legs. It reminds me at times of that feeling when you chew on tinfoil. The shaking (whole body) wakes me at night and at times makes it impossible to drive, write, weave, or play my musical instrument. This week, I've had moments where my head literally wags like a dog's tail. My feet Charlie horse painfully. My upper arms and legs are developing a pervasive weakness, and I'm now unsteady on my feet. I'm sleeping more, napping many times in a day, and my usually boundless physical stamina is gone. Today I've had times of breathlessness. I can no longer function normally. If this continues, I will end up "disabled".
61 2021-05-15 disturbance in attention Day 1: injection site soreness, headache, fever, chills, body aches, air hunger, O2sat = 91. Day 2: ... Read more
Day 1: injection site soreness, headache, fever, chills, body aches, air hunger, O2sat = 91. Day 2: extreme fatigue, headache, fever, chills, body aches, unable to eat (food revulsion), unable to concentrate, word loss, blurry vision, eye pain, moderate air hunger, O2 sat = 94. Day 3: fever, headache, eye pain, swollen lymph glands left side, dizzy, chills, body aches, loss of appetite, fatigue, mild sob, O2 sat = 97. Day 4: fatigue, body aches, eye pain, left side lymph gland swelling., O2 sat 97.
61 2021-05-16 nightmare 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 2021-05-17 insomnia Patient received her first Moderna vaccine on 12/30/2020. Four days later she developed a "pink str... Read more
Patient received her first Moderna vaccine on 12/30/2020. Four days later she developed a "pink streak" on her arm and pain. Since then (4 months later) she is still having significant pain in her arm that causes disruption in her sleep and decrease in range of motion. She has tried NSAIDs and will be starting physical therapy. She received her second Moderna vaccine in her right arm which "swelled up like a sausage and was pink" but there no pain.
61 2021-05-18 disturbance in attention Full body twitching, arms and feet numbness, ringing in ears, buzzing in body, lack of concentration
61 2021-05-19 feeling abnormal 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 insomnia At approximately 1:00 PM, the injection site in the right arm became very painful. By 8:00 PM, I ha... Read more
At approximately 1:00 PM, the injection site in the right arm became very painful. By 8:00 PM, I had a fever of 101 F and chills. After taking 400 mg of Ibuprofen, the fever had reduced to 100 F. Sleeping was not possible on the right arm due to the pain. The pain has continued into today (5/22/2021), one day after the injection.
61 2021-05-23 anxiety, crying, emotional distress, sleep disorder Severe ringing/buzzing in my ears within two hours of the vaccine. I contacted my ENT on April 9th,... Read more
Severe ringing/buzzing in my ears within two hours of the vaccine. I contacted my ENT on April 9th, April 15th and May 5th. I was scheduled for testing with an audiologist.
61 2021-05-23 feeling abnormal This case was received via VAERS (Reference number: 1194270) on 11-May-2021 and was forwarded to Mod... Read more
This case was received via VAERS (Reference number: 1194270) 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 FEELING ABNORMAL (felt bad) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. 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 13-Mar-2021, the patient experienced FEELING ABNORMAL (felt bad) (seriousness criteria hospitalization). At the time of the report, FEELING ABNORMAL (felt bad) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Platelet count: (Low) decreased. 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 and treatment medications 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 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.
61 2021-05-24 insomnia 8 hours post vaccine I felt the symptoms creek through my body .As it crept across by chest from lef... Read more
8 hours post vaccine I felt the symptoms creek through my body .As it crept across by chest from left to right like a spider web I realized I was aware of my lymphatic system. It crept down my body to my kidneys then thighs but was most alarming when my TOES went numb. I AM SO Grateful for the vaccine 1.Point tenderness lasted 4 months at IM site but continue to have Pain with specific arm movements ( reaching motion with left arm) 2. First 12 hours fever chills, that eventually resolved in 12 hours ( NO Tylenol or Motrin for first 24 hours) 3.back pain over kidneys resolved 12 hours 4. Numbness to all 10 toes resolves 12 hours 5.CHRONIC SYMPTOMS Bilateral. Soles of my feet ( burning ,tingling ,hot always at night causing chronic insomnia) relief comes only by taking Gabapentin 6.Insomnia r/t feet symptoms
61 2021-05-25 feeling abnormal immune system was not working; everything(blood parameters) went down, blood levels went really low;... Read more
immune system was not working; everything(blood parameters) went down, blood levels went really low; Missed the 2nd dose of Moderna vaccine because of hospitalization; weakness; fullness following eating little; felt really bad; nausea; stools were really black in color; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE SYSTEM DISORDER (immune system was not working) and VOLUME BLOOD DECREASED (everything(blood parameters) went down, blood levels went really low) 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. Concomitant products included FLUTICASONE for Allergy, AMLODIPINE for Blood pressure management, ONDANSETRON for Nausea, SUCRALFATE for Stomach ulcer, SPIRONOLACTONE for Water retention, CLOPIDOGREL, GABAPENTIN and MONTELUKAST SODIUM (MONTELUKAST OD) for an unknown indication. On 27-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 FAECES DISCOLOURED (stools were really black in color), ASTHENIA (weakness), ABDOMINAL DISTENSION (fullness following eating little), FEELING ABNORMAL (felt really bad) and NAUSEA (nausea). On 15-Apr-2021, the patient experienced IMMUNE SYSTEM DISORDER (immune system was not working) (seriousness criterion hospitalization) and VOLUME BLOOD DECREASED (everything(blood parameters) went down, blood levels went really low) (seriousness criterion hospitalization). On 24-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of Moderna vaccine because of hospitalization). The patient was hospitalized from 15-Apr-2021 to 18-Apr-2021 due to IMMUNE SYSTEM DISORDER and VOLUME BLOOD DECREASED. On 24-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of Moderna vaccine because of hospitalization) had resolved. At the time of the report, IMMUNE SYSTEM DISORDER (immune system was not working), VOLUME BLOOD DECREASED (everything(blood parameters) went down, blood levels went really low), FAECES DISCOLOURED (stools were really black in color), ASTHENIA (weakness), ABDOMINAL DISTENSION (fullness following eating little), FEELING ABNORMAL (felt really bad) and NAUSEA (nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Vitamin B12: decreased not producing enough B12 and everything(blood parameter's ) went down. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient received B12 shot at the hospital and got discharged from the hospital on 18Apr2021 with discharge prescription for B12 Shot to be continued. Patient reported, Doctor at the hospital quoted, that, "thought of giving the blood transfusion at one point since the blood levels went really low 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.
61 2021-05-25 sleep disorder pt says about 30 hours after getting the 1st covid vax she had muscular pain all over her body but e... Read more
pt says about 30 hours after getting the 1st covid vax she had muscular pain all over her body but extremely bad in the lower back and was unable to walk. She had trouble getting around due to the intense pain and has not been able to sleep more than 4 hours per night yet feels very tired. She has a head ache along with restless muscles. She had a flare up of her skin disease. These symptoms were still present but was getting better when she got the 2nd dose of the covid vax on 5/20/21 (right arm Lot# 039B21A). About 24 hours after getting 2nd dose she developed all of the same symptoms she had after getting the 1st dose but more aggressive. She spoke to Dr. and he told her he could up her prednisone meds which she decided not do. Pt says she feels like her symptoms are slowly improving at this time.
61 2021-05-29 sleep disorder, amnesia Please note: 1st dose on RIGHT Arm, 2nd dose on LEFT Arm. First Dose, Moderna, Lot Number: 044A21A o... Read more
Please note: 1st dose on RIGHT Arm, 2nd dose on LEFT Arm. First Dose, Moderna, Lot Number: 044A21A on 3/10/2021 1st day, 3/10/2021 only slight pain LEFT arm (vaccination arm) that evening. 3/11/2021 more pain in arm and just tired. 3/12/2021 body (achy) all over and dizzy all day. 3/13/2021 dizziness continued and tiredness set in (forced myself to get up and go!). 3/14/2021 extreme fatigue now in full force, no appetite and a slight metal fog. 3/15/2021 fatigue continued, dismissed appetite (forcing myself to eat) and still having body aches. 3/16/2021 still feeling run down, however dizziness dismissed. 3/17/2021 started to feel better but body ache continued. 3/18/2021 some symptoms started to improve but fatigue and lack of concentration continued. 2nd Dose, Moderna, Lot Number: 036B21A on 4/07/2021 on 4/07/2021 only slight pain RIGHT arm (vaccination arm) that evening, staying hydrated as suggested by the nurse 4/08/2021 no bad symptoms but injection site was bruised and raised, not sure why. 4/09/2021 started to feel tired and my right shoulder was hurting a bit. 4/10/2021 extreme pain under arm pit of right arm, achy all over and tired. 4/11/2021 swelling of lymph nodes under my arm and neck. Felt really sick and achy all over. Diminished energy and no taste. Forced myself to eat. I continued to stay well hydrated. From 4/11/2021 through 5/01/2021: The swelling under the right armpit continued to increase in size and the pain continued to increase. At one point I could hardly touch the area and I was having problems sleeping. My Right armpit and arm and my neck continue to bother me to no end. I could not sleep well and my Metal fog increased. Short Memory loss: I could not remember things that I did just a few seconds before. Since I had started a log to record my progress with my vaccinations, I kept writing all symptoms and problems down. I developed COVID Arm. My appetite has decreased, and I was very, very tired all of the time during this period. 5/02/2021 I started to feel better but unknown to me, my natural body defenses were down. Any little cut or scratch was not healing. And I was still having short memory lapses and occasional fatigue spells. I was relatively healthy before!! 5/04/2021 I had a run in with a wasp and I scratched my Left eye while trying to defend my eye from this insect. 5/07/2021 I had developed eye problems on my left eye and an infection on my face, left eye lid and ocular ulcers inside my left eye. I also had macular abrasions. I went to my Primary Care Provide and she prescribed oral antibiotics Doxycycline HYC 100MG, 1 daily for 30 days and an antibiotic ointment Erythromycin OPHTH Oin.t 3.5MG, 4 times per day for 5 days. 5/10/2021 My eye problem and infection got worse so I was referred to my Ophthalmologist. She confirmed that my Left eye and eyelid and cheek were infected and she added an antibiotic eye drop to the list of medications. 5/12/2021 My left eye hurts a lot and the left side of my face hurt a lot, so I was directed to proceed to the nearest Emergency Room. The ER Doctor changed my antibiotic to Clindamycin 300 MG, every 6 hours for 10 days. 5/26/2021 after finishing the Clindamycin antibiotics I had developed Thrush of the Mouth and I went to an Urgent Care facility, while there they checked my problems and drew a culture and prescribed Nystatin Oral Suspension, 1000MG, at 6 ML, every 6 hours for 7 days or until the Thrush causing Yeast Fungi is eliminated. I'm still suffering from a compromised immune system directly related to the COVID 19 Moderna Vaccinations. I'm still trying to put my life back together and I'm still dealing with the dangers of infections taking over my body from this fragile state. The Moderna Covid Vaccine has brought havoc into my life. Please use this information to warn others of side effects. Please provide additional information to the general public on steps that can be taken by the Covid vaccination recipients to make our immune system strong again. How do we now deal with metal fog? How can we deal with short memory lapses? How can we fend off infections? Please Help! 5/30/2021 In conclusion, the Moderna COVID vaccines have changed my life and I'm still living a nightmare filled with problems and infections from a greatly diminished and compromised immune system. I do not know how long will my body and health will continue to be compromised, all I know that I'm not the same. I still have to be careful with any little scratches and even paper cuts do not heal! I'm still taking antibiotics today and dealing with health problems that were not present before my COVID Moderna vaccinations.
61 2021-06-01 feeling abnormal, thinking abnormal sore arm, headache on both shots. after 2nd vaccine, within a week, started having brain fog/fuzzy... Read more
sore arm, headache on both shots. after 2nd vaccine, within a week, started having brain fog/fuzzy/dizziness with thickness inside of head. Sharp pains in the head in different spots randomly. Still getting worse each day, affecting ability to think.
61 2021-06-02 confusional state, amnesia Vertigo, neuropathy, neurological changes that brought confusion and memory loss, fatigue
61 2021-06-02 feeling abnormal She got her vaccine, while she was in the car coming home she started with a headache in the back of... Read more
She got her vaccine, while she was in the car coming home she started with a headache in the back of her head, and also felt spacy, night right. Had this with the first one but that was minor. By the time she got home (1 1/2 hours), her stomach felt funny and had vicious diarrhea immediately and started throwing up. She still cannot hold down anything. She does take Zofran on a regular basis to hold down liquids. She has not been able to eat food since the vaccine. She went to the ER after being sick for 5 days, and she was admitted as her potassium was under 2 and she had to go the cardiac unit as she was susceptible for a heart attack and a stroke. They gave her 4 bags of potassium and her potassium level actually went down due to the vomiting and diarrhea, and then took potassium pills and drink to get it up to 3 so that she could leave the hospital, which she did on 5/20/21. She was okay during this time and very exhausted and still not able to eat. Was discharged home with Compazine and Zofran. On June 31st she started throwing up again and has no energy and still cannot eat and having the diarrhea again. She is forcing fluids after taking the Zofran and then throws up again. She has not called her PCP to inform them that she is still throwing up.
61 2021-06-06 confusional state Pt got Moderna COVIDvaccine on 6/4/21 in the evening and said she had some headache on 6/5/21 we to... Read more
Pt got Moderna COVIDvaccine on 6/4/21 in the evening and said she had some headache on 6/5/21 we told her to take Tylenol and let us know if it helped or got worse. She called back today 6/7/21 stating that the Tylenol worked for the headache. However, her husband mentioned to her that over the previous 24 hours, she had episodes of confusion where she didn't understand what he was saying. We gave her VAERS phone number so she could report it and counselled her to go to the ER to get proper care and to reach out to us about the outcome of the visit
61 2021-06-06 insomnia About 8 hours following injection, ears started ringing on both sides. I went to the ENT and neurol... Read more
About 8 hours following injection, ears started ringing on both sides. I went to the ENT and neurologist, awaiting MRI. Over the counter remedies (Ring Stop) have not been helpful. As a result of the vaccine, I have constant ringing in both ears all day long, cannot sleep, and need to use a sound machine to block out some of the sounds from the tinnitus.
61 2021-06-07 anxiety On the day of the vaccine 12/23/2020- nothing signficant, just a little arm soreness. 2 weeks later... Read more
On the day of the vaccine 12/23/2020- nothing signficant, just a little arm soreness. 2 weeks later when I woke up, I notice my hand between my thumb and pointer finger was swollen- it was painful to the touch. I also noticed a red streak from right arm to elbow. It was a burning sensation. I took ibuprofen twice a day for a week, then changed to Tylenol 650mg for another week. I went to see the doctor. He tested for 2 types of arthritis which came back negative. He prescribed me Meloxicam (pain) and Buspar (anxiety). I took meloxicam for 2 weeks and started having severe acid reflux. I was prescribed Nexium to treat the reflux. I started to have chest pains and had a whole work up to rule out cardiac issues. I slowly weaned myself off the medications. 2 weeks later, my left arm was affected with swollen thumb to pointer finger. Now, I am see an acupuncture and most symptoms have resolved. The red streak is almost gone and the swelling has decrease by 50%.
61 2021-06-07 feeling abnormal Sore tongue; Loss of teeth; Drug interaction; Feeling hot; Discopathy; Feeling bad; Yeast infection ... Read more
Sore tongue; Loss of teeth; Drug interaction; Feeling hot; Discopathy; Feeling bad; Yeast infection of the skin; Extremties itchy sensation; Eye swelling; cold; Diarrhea; Cramps of extremities; Back discomfort; Neck pain; red rash; Back arthritis; injection site pruritus; Nauseous; Itchy eyes; Eyes red; Watering eyes; allergy; Swelling of legs; Rheumatoid arthiritis aggravated; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthiritis aggravated) 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 products included non-company products ADALIMUMAB (HUMIRA) injection, solution for Rheumatoid arthritis, PROMETHAZINE for an unknown indication, OXYBUTYNIN for an unknown indication and AZITHROMYCIN (Z-PAK) for an unknown indication. The patient's past medical history included Rheumatoid arthritis, Low back pain in 2018 and Hernia repair (and mesh) in 2018. In 2013, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. In 2019, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram once a week. 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, ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose., PROMETHAZINE (Subcutaneous) at an unspecified dose, OXYBUTYNIN (unknown route) at an unspecified dose and AZITHROMYCIN (Z-PAK) (unknown route) at an unspecified dose. In December 2020, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthiritis aggravated) (seriousness criterion medically significant). On 04-Mar-2021, the patient experienced HYPERSENSITIVITY (allergy). In March 2021, the patient experienced PERIPHERAL SWELLING (Swelling of legs). On 19-May-2021, the patient experienced EYE PRURITUS (Itchy eyes), OCULAR HYPERAEMIA (Eyes red) and LACRIMATION INCREASED (Watering eyes). On an unknown date, the patient experienced GLOSSODYNIA (Sore tongue), TOOTH LOSS (Loss of teeth), DRUG INTERACTION (Drug interaction), FEELING HOT (Feeling hot), INTERVERTEBRAL DISC DISORDER (Discopathy), FEELING ABNORMAL (Feeling bad), FUNGAL SKIN INFECTION (Yeast infection of the skin), PRURITUS (Extremties itchy sensation), EYE SWELLING (Eye swelling), FEELING COLD (cold), DIARRHOEA (Diarrhea), MUSCLE SPASMS (Cramps of extremities), MUSCULOSKELETAL DISCOMFORT (Back discomfort), NECK PAIN (Neck pain), RASH ERYTHEMATOUS (red rash), SPONDYLITIS (Back arthritis), VACCINATION SITE PRURITUS (injection site pruritus) and NAUSEA (Nauseous). The patient was treated with HYDROCODONE at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthiritis aggravated), GLOSSODYNIA (Sore tongue), FEELING ABNORMAL (Feeling bad), FUNGAL SKIN INFECTION (Yeast infection of the skin), MUSCLE SPASMS (Cramps of extremities), HYPERSENSITIVITY (allergy), PERIPHERAL SWELLING (Swelling of legs), SPONDYLITIS (Back arthritis), EYE PRURITUS (Itchy eyes), OCULAR HYPERAEMIA (Eyes red) and LACRIMATION INCREASED (Watering eyes) had not resolved, TOOTH LOSS (Loss of teeth), INTERVERTEBRAL DISC DISORDER (Discopathy), PRURITUS (Extremties itchy sensation), EYE SWELLING (Eye swelling), FEELING COLD (cold), MUSCULOSKELETAL DISCOMFORT (Back discomfort), NECK PAIN (Neck pain) and NAUSEA (Nauseous) outcome was unknown, DRUG INTERACTION (Drug interaction), FEELING HOT (Feeling hot) and DIARRHOEA (Diarrhea) was resolving and RASH ERYTHEMATOUS (red rash) and VACCINATION SITE PRURITUS (injection site pruritus) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Lab Result: Pain scale: Unknown test date - no results reported Uric acid test: Unknown test date - no results reported Urine test: 27-Apr-2021 - no results reported Vitamin D test: Unknown test date - no results reported X-Ray: ??-Mar-2021 - no results 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. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up 2 information included additional events eye pruritus, ocular hyperaemia, lacrimation increased, and spondylitis. Outcome of events nausea and diarrhea updated to recovering. Outcome of events muscle spasms and fungal skin infection updated to not recovered.; 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.
61 2021-06-07 feeling abnormal 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 feeling abnormal 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 sleep disorder I had a rash that was all over her body that would flip to different parts of the body at various ti... Read more
I had a rash that was all over her body that would flip to different parts of the body at various times on my legs, tops of hands, elbows, chest, stomach and buttocks. My arm was very red following the shot and very hot. I had rashes before hand and took the shingles vaccine and the rashes became much worse nothing would clear it up. The vaccine I took was Shingrix. I was advised not to get second shingles shot by my doctor. I had hives with both Moderna vaccines. The rashes were so bad I could not sleep the only thing that really helped was ice. The rash is still on my left leg currently. It is improving but still here.
61 2021-06-10 feeling abnormal Headache lasting >4 days. Possible autoimmune reaction (similar to what patient experiences during ... Read more
Headache lasting >4 days. Possible autoimmune reaction (similar to what patient experiences during prior remicaide treatments) sores on face/trunk/legs. Brain fog including difficulty with speaking. Fatigue and extreme exhaustion, which occurred with 1st and 2nd dose.
61 2021-06-10 impaired work ability, agitation 745pm, after shot, Jan 18th, i felt tingling in legs and arms, by 9pm i felt very agitated, & uncomf... Read more
745pm, after shot, Jan 18th, i felt tingling in legs and arms, by 9pm i felt very agitated, & uncomfortable. I started getting redness on my forearms and the itching began. I called health care provider & saw them on Tues, i believe. I was told to get OTC allergy meds. Itching continued. I was also told if itching continued i would be prescribed steroids. On Thursday, i was in so much distress, i couldn't not go to work. I then saw Dr., he prescribed prednisone.
61 2021-06-10 loss of personal independence in daily activities, impaired work ability I had the vaccine and after about 3 hours I went home I took a shower and I felt horrible with sever... Read more
I had the vaccine and after about 3 hours I went home I took a shower and I felt horrible with severe fatigue, I started running a fever, did not eat supper, was not feeling good and had diarrhea, by the end of the day I was throwing up, had chills, and a head ache, I had every symptom other than shortness of breath. It lasted for 4 days. I did not get out of the bed, only to go to the restroom and with assistance. I contacted the hospital and talk to the nurse that was in charge of the vaccination program . My arm was red about 9 cm size swollen, elevated. I could not brush my teeth, hair, wash my face or take a shower. I used baby wipes to wipe my behind. It was awful. I was totally useless, unable to work, unable to do anything. I contacted my practitioner and told her what was going on. I still have fatigue and muscle and joint pain that I did not have before. I took all of my migraine medications available and that did not touch it. I stayed in bed. I never had a headache like this before. My practitioner told me that many people that had the same vaccine had the same symptoms. My tempt went up to 102 and that is not normal for me. I did not go to the ER because I was not having difficulty breathing.
61 2021-06-13 insomnia 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 2021-06-15 confusional state sodium level 20; fatty liver; something wrong with kidneys; diarrhea; bone ache; could not walk; fev... Read more
sodium level 20; fatty liver; something wrong with kidneys; diarrhea; bone ache; could not walk; fever; confusion; Not feeling good; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of HYPONATRAEMIA (sodium level 20), HEPATIC STEATOSIS (fatty liver), RENAL DISORDER (something wrong with kidneys), DIARRHOEA (diarrhea), BONE PAIN (bone ache), GAIT DISTURBANCE (could not walk), PYREXIA (fever) and CONFUSIONAL STATE (confusion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPONATRAEMIA (sodium level 20) (seriousness criterion hospitalization), HEPATIC STEATOSIS (fatty liver) (seriousness criterion hospitalization), RENAL DISORDER (something wrong with kidneys) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization), BONE PAIN (bone ache) (seriousness criterion hospitalization), GAIT DISTURBANCE (could not walk) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization prolonged), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization prolonged), MALAISE (Not feeling good) and VOMITING (Throwing up). At the time of the report, HYPONATRAEMIA (sodium level 20), HEPATIC STEATOSIS (fatty liver), RENAL DISORDER (something wrong with kidneys), DIARRHOEA (diarrhea), BONE PAIN (bone ache), GAIT DISTURBANCE (could not walk), PYREXIA (fever), CONFUSIONAL STATE (confusion), MALAISE (Not feeling good) and VOMITING (Throwing up) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood sodium: 20 (Inconclusive) 20. In 2021, Body temperature: 104 (High) 104 Fahrenheit. In 2021, SARS-CoV-2 test: negative (Negative) rapid test as well as the PCR were negative. Patient reported that her liver enzymes were elevated. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
61 2021-06-15 memory impairment, mental impairment, feeling abnormal Immediately after I got the vaccine, I tested sugar, in the back of my throat, like fake sugar. Aft... Read more
Immediately after I got the vaccine, I tested sugar, in the back of my throat, like fake sugar. After 12 hrs. I got headache and fever (104.6) ( could have be higher) I took a cold shower, to get temperature down. I cracked my teeth guard from my jaw, and I have brain fogs and hard time finding words. I have a PHD and now I can?t think. Affected my memory and speech, I have joint pain. I called and they told me to go to ER if fever reaches 105 but I managed to have the temperature down, so I did not have to go back.
61 2021-06-16 anxiety 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 2021-06-18 sleep disorder Several hours after receiving this vaccine (first dose), my right ear began to hurt. The pain intens... Read more
Several hours after receiving this vaccine (first dose), my right ear began to hurt. The pain intensified as the evening wore on. The next morning the pain was gone, but I had ringing in my ear. In the past I have had some very mild, short-lived bouts of tinnitus before, but this was more intense than I'd ever experienced before. The ringing was loud enough that it broke through daily noise. It was loud enough to break through even during boisterous conversations in a room in which the television set also turned on. It was also so loud that it interfered with my sleep. Over the course of the past several months the ringing in my ears has become softer, but it is still there and still occassionally breaks through the ambient noises of daily life.
61 2021-06-18 sleep disorder 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 2021-06-20 anxiety patient was nervous about getting the shot. she said she felt dizzy and hot afterward. she stayed ... Read more
patient was nervous about getting the shot. she said she felt dizzy and hot afterward. she stayed an extra 30 minutes b/c she was nervous. no noticeable side effects were seen. just anxious.
61 2021-06-20 anxiety blistering fingertips, increased anxiety, muscle aches, joint pain
61 2021-06-20 feeling abnormal On my left hand, the knuckle above my middle finger became more swollen and warm to the touch. I had... Read more
On my left hand, the knuckle above my middle finger became more swollen and warm to the touch. I had a fever and it was 100.5. I couldn't move my muscles since it hurt. To lift the phone was very difficult. Awful headaches and stomach aches and moving anything hurt. My neck injury was hurt. Every joint was sore/inflamed. I felt like everything that has ever happened to me intensified and lasted 36 hours until I started able to move. My hand was still swollen. That head to toe muscle was good. I have had intermittent fatigue and brain fog. My taste is fine but my physical injuries were horrible. It was my body and muscular joints were in pain and feeling the flu like sick feeling. My body had a lot of intensity until 36 hours had passed. It feels like I'm a lot more weaker and I haven't been able to see my rheumatologist since 2012 when I had the fall for my neck injury. The blood work now is not good since it shows everything out of range and I am positive for DNS antibody. DS DN antibody for systemic lupus was 50.0. I had this bloodwork and I don't know why all these things were out of range. I felt like a number in and out... I am hoping to find the answers.
61 2021-06-20 sleep disorder Pain in upper left arm. Restricted range of motion. Difficulty sleeping as I bend my arm. Have to f... Read more
Pain in upper left arm. Restricted range of motion. Difficulty sleeping as I bend my arm. Have to find correct spot to bend it! PT Ongoing
61 2021-06-21 disorientation Patient stated that she stated experiencing dizziness and extreme weakness and she was very disorie... Read more
Patient stated that she stated experiencing dizziness and extreme weakness and she was very disoriented. Patient also stated that she was off balance. 911 was Called and transported patient to the ER. Patient stated that she is very tired and weak.
61 2021-06-30 insomnia ribs tender to touch; pain constant and wakes her up at night; ultrasound showed left axilla lymph n... Read more
ribs tender to touch; pain constant and wakes her up at night; ultrasound showed left axilla lymph node doubled in size; 2 additional lymph nodes found; pain worsen in March/pain constant and wakes her up at night; lump/swelling in back and under breast; sore left arm; sick in bed for 3 days after dose 2; sweats, drenched clothes; complete body aches and pain; nausea; chills; fever of 102.9F; Benign lymph node found in left/right axillary region; Left underarm felt achy; left sore arm; Diagnosed with uterine cancer; This spontaneous case was reported by an other health care professional and describes the occurrence of UTERINE CANCER (Diagnosed with uterine cancer) in a 62-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. The patient's past medical history included Total hysterectomy (For treatment of cancer) on 29-Jan-2021. Concomitant products included DENOSUMAB (PROLIA) 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 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (left sore arm). On 08-Jan-2021, the patient experienced AXILLARY PAIN (Left underarm felt achy). On 13-Jan-2021, the patient experienced BENIGN LYMPH NODE NEOPLASM (Benign lymph node found in left/right axillary region). In January 2021, the patient experienced UTERINE CANCER (Diagnosed with uterine cancer) (seriousness criterion medically significant). On 03-Feb-2021, the patient experienced ILLNESS (sick in bed for 3 days after dose 2), HYPERHIDROSIS (sweats, drenched clothes), PAIN (complete body aches and pain), PAIN IN EXTREMITY (sore left arm), NAUSEA (nausea), CHILLS (chills) and PYREXIA (fever of 102.9F). On 01-Mar-2021, the patient experienced PAIN (pain worsen in March/pain constant and wakes her up at night) and SWELLING (lump/swelling in back and under breast). On 14-Jun-2021, the patient experienced LYMPHADENOPATHY (ultrasound showed left axilla lymph node doubled in size; 2 additional lymph nodes found). On an unknown date, the patient experienced TENDERNESS (ribs tender to touch) and INSOMNIA (pain constant and wakes her up at night). The patient was treated with Surgery (total abdominal hysterectomy) for Uterine cancer. On 09-Jan-2021, PAIN IN EXTREMITY (left sore arm) had resolved. On 06-Feb-2021, ILLNESS (sick in bed for 3 days after dose 2), HYPERHIDROSIS (sweats, drenched clothes), PAIN (complete body aches and pain), PAIN IN EXTREMITY (sore left arm), NAUSEA (nausea), CHILLS (chills) and PYREXIA (fever of 102.9F) had resolved. At the time of the report, UTERINE CANCER (Diagnosed with uterine cancer), BENIGN LYMPH NODE NEOPLASM (Benign lymph node found in left/right axillary region), PAIN (pain worsen in March/pain constant and wakes her up at night), SWELLING (lump/swelling in back and under breast), TENDERNESS (ribs tender to touch), INSOMNIA (pain constant and wakes her up at night), AXILLARY PAIN (Left underarm felt achy) and LYMPHADENOPATHY (ultrasound showed left axilla lymph node doubled in size; 2 additional lymph nodes found) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Mammogram: benign lymph node (Inconclusive) Benign lymph node was found in left and right axillae. This was a new finding.. 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 was included hysterectomy for cancer. This case concerns a 62-year-old female with a serious unexpected event of uterine cancer, and nonserious benign lymph node neoplasm, pain in extremity, axillary pain and other nonserious events. 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.; Sender's Comments: This case concerns a 62-year-old female with a serious unexpected event of uterine cancer, and nonserious benign lymph node neoplasm, pain in extremity, axillary pain and other nonserious events. 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.
61 2021-07-02 memory impairment I was driving and I lost some time. Meaning, I can't remember driving along some of the route. I rem... Read more
I was driving and I lost some time. Meaning, I can't remember driving along some of the route. I remember driving behind some other cars on one road and the next thing I knew I was on a different road sitting at a red light. It was approximately 2-3 minutes (since I took the same route at a later date to calculate this). It was only a one time event .
61 2021-07-06 impaired work ability 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 2021-07-06 sleep disorder I had typical common side effects for the two days following the second vaccine (fever, chills, body... Read more
I had typical common side effects for the two days following the second vaccine (fever, chills, body ache and head ache). Beginning on third day following the second vaccine started severe pain in back of neck, left should blade and arm. Started on Celebrex and steroid to help with inflammation. Nothing is cutting the pain. Muscle relaxers along with prescription pain medication helps slightly. Pain is severe still almost one month later with only being able to sleep a couple of hours at night because of pain. Pain seems to be worse at night than during the day.
61 2021-07-07 impaired work ability 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 2021-07-11 feeling abnormal Patient received first dose moderna vaccine on 7/12/21 at approximately 1235. Patient requested assi... Read more
Patient received first dose moderna vaccine on 7/12/21 at approximately 1235. Patient requested assistance due to "having an allergic reaction" at 1250. Patient reports, feeling "a little dizzy", lips tingling, and "it feels like when I go into a-fib." Initial vital signs: 140/70, 80 HR, 95% on RA, 17 RR. Patient stated during initial vital signs that her symptoms were resolving. Patient denied any shortness of breath, throat swelling or chest pain. Requested patient remain for 10-15 additional minutes of monitoring. At 1305 patient stated symptoms were resolved. Vital signs as follows: 130/72, 83 HR, 16 RR, 93% on RA.
61 2021-07-12 insomnia Patient reported that after the 2nd dose she wasn't able to sleep... the symptoms haven't gotten any... Read more
Patient reported that after the 2nd dose she wasn't able to sleep... the symptoms haven't gotten any better....and she has a lump under her left arm pit that hasn't gone away
61 2021-07-13 feeling abnormal Right after the vaccine, I felt bad for the day and the next day, I woke up and felt tired but nothi... Read more
Right after the vaccine, I felt bad for the day and the next day, I woke up and felt tired but nothing that kept me from doing anything And the next day after that everything was fine. On June 26, No fever or anything. I just had an earache and I gave it a couple of days to see if it would go away on its own. By Tuesday, I called the doctor and they got me in Thursday. It looked like my left ear was a little red - and right ear looked fine. Prescribed antibiotics for two weeks and I took those and I went back last Thursday and it looked better. She's my ear doctor and she knows me as she has done surgery on my ears. I have had a lot of ear issues before but this was the first time I have ever had an earache.
61 2021-07-16 loss of personal independence in daily activities Exercise intolerance; shortness of breathe during exercise
61 2021-07-19 emotional distress I had a rash all over my body that turned into cellulitis. It turned into a bacteria infection all o... Read more
I had a rash all over my body that turned into cellulitis. It turned into a bacteria infection all over my body. The doctor gave me Augmentin 500mg 2xday, and I was on prednisone 60 mg for a couple months. I was on Valtrex for herpes simplex which was on my lips, mouth, and face but not my eyes. I'm still having bouts of the herpes simplex and the rash. It feels like poison ivy. I was on multiple steroid creams for the skin. I was on Xyzal medication at night and Claritin in the morning. The doctor wants me to come in after the meds are out of my system for blood work and lab work. They want to do a CT scan and MRI for my internal organs to make sure my body is okay because my body went into IT syndrome. I am very tired and lethargic and I never used to be. I have chronic fatigue also. It has affected my mental health because of the unknown because before the vaccine I was healthy but now I am not well at all.
61 2021-07-20 fear, impaired work ability 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 feeling abnormal 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 2021-01-03 sensation of foreign body Patient left building and started to walk to car and turned around with c/o "lump in throat. She c/... Read more
Patient left building and started to walk to car and turned around with c/o "lump in throat. She c/o tightening in throat and hard to swallow. She was taken to EMS, 50 mg IM was given and symptoms subsided in about one hour with her going home with husband 90 minutes after start of symptoms. O2 sat 100% , BP at start was 170/80, hr-100, and at departure was 120/78, HR-80.
62 2021-01-03 sensation of foreign body Patient left building and started to walk to car and turned around with c/o "lump in throat". She c/... Read more
Patient left building and started to walk to car and turned around with c/o "lump in throat". She c/o tightening in throat and hard to swallow. She was taken to EMS, 50 mg IM was given and symptoms subsided in about one hour with her going home with husband 90 minutes after start of symptoms. O2 sat 100% , BP at start was 170/80, hr-100, and at departure was 120/78, HR-80
62 2021-01-05 anxiety 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 2021-01-05 feeling abnormal 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 sensation of foreign body Approximately 4-5 min after leaving the facility in my car after my 15 minute check, I began to feel... Read more
Approximately 4-5 min after leaving the facility in my car after my 15 minute check, I began to feel throat tightness -upper pharynx/larynx region - like something was stuck or like I swallowed something - no difficulty breathing, just constant throat clearing like something was stuck on both sides of my upper pharynx/larynx region. I was monitored by EMS and given 50 mg IM Benadryl. After 30 - 40 min. symptoms cleared.
62 2021-01-07 confusional state 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 impaired work ability At 2 am, I woke up to severe chills and body aches, and horrible migraine. I checked my temperature ... Read more
At 2 am, I woke up to severe chills and body aches, and horrible migraine. I checked my temperature and it was 100.7. It continued to climb to 102.8. I took Tylenol and Ibuprofen all night and all day and could not get relief. I missed a day of work because of this. I am still with fever as of 5:55 pm and the body aches and migraine. This was not explained to me. I feel like I did when I had Corona on the worst days. I am really praying that this ends so that I can go back to work tomorrow. I thought that someone was supposed to call and check on us each day....
62 2021-01-08 anxiety 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 2021-01-08 confusional state Confusion, Headache, Myalgia, Arthralgia, Diarrhea & NauseaVomiting Narrative:
62 2021-01-08 feeling abnormal, fear THE NEXT DAY I FEEL TOOO BAD I HAVE HIGH FIVER, BODI PAIN, HEADACHE, NECK PAIN , AND TOO COOL I TA... Read more
THE NEXT DAY I FEEL TOOO BAD I HAVE HIGH FIVER, BODI PAIN, HEADACHE, NECK PAIN , AND TOO COOL I TAKE TYLENOL AND AVIL EVERY 4 HOURS I DONT GO TO THE HOSPITAL BECAUSE I SCARE
62 2021-01-10 impaired work ability very sore left arm with in hrs . Went on to devlop 7/10 neck left shoulder joint and lower back pain... Read more
very sore left arm with in hrs . Went on to devlop 7/10 neck left shoulder joint and lower back pain with in hrs . Extreme exhustion and nausea, headache -couldnt eat dinner on thursday night had a brief left ear ache through the night and periods of extreme chills /shaking , no food friday , called out sickNow RIGHT arm hurting ! -symptoms continued went to bed at 1800 hrs and woke up at midnight with soaking wet bedlinens and pjs . Family helped me change linen . Took M otrin 800mgs po and slept throguh the rest of the night woke up sat AM and was perfectly fine , hungry and back to usual self ( Of interest : was hospitalized with COVID 19 pneumonia march 2020 for one week ,received the anti malaria drug ( at that time was the recommended tx .) Still tested positive 4 months out in July 2020 at location(that sample is frozen at facility - and have not rested ( maybe had an acute response to the vaccine due to antibodies from primary infection ???
62 2021-01-10 insomnia SOB, Sleeplessness,
62 2021-01-11 agitation Developed some hives and generalized itchy feeling, feeling of agitation. Took Benedryl 25 mg P.O.,... Read more
Developed some hives and generalized itchy feeling, feeling of agitation. Took Benedryl 25 mg P.O., , hives and itching gone by morning.
62 2021-01-11 disturbance in attention, impaired work ability Myalgia Difficulty concentrating and fatigue resolved in 24 hours Narrative: She called into work fo... Read more
Myalgia Difficulty concentrating and fatigue resolved in 24 hours Narrative: She called into work for one day and rested
62 2021-01-11 fear REDNESS AND PAIN AT INJECTION SITE X 36 HOURS SEVERE BONE PAIN X 24 HOURS 104.8 FEVER OFF AND ON FOR... Read more
REDNESS AND PAIN AT INJECTION SITE X 36 HOURS SEVERE BONE PAIN X 24 HOURS 104.8 FEVER OFF AND ON FOR 24 HOURS
62 2021-01-11 sleep disorder The same day I got arm tenderness. The 3rd day, I started having waves of nausea after the 3rd day ... Read more
The same day I got arm tenderness. The 3rd day, I started having waves of nausea after the 3rd day and feel generally Ill. Feel sick off an on and some days are bad enough that they wake me up during the night.
62 2021-01-11 sleep disorder I have a knot the size of a quarter that is raised, red and hot. My upper arm is sore and woke me se... Read more
I have a knot the size of a quarter that is raised, red and hot. My upper arm is sore and woke me several times during the night when I rolled on it.
62 2021-01-13 agitation Patient reports a rash at injection site that was first noticed today. Reports tender to touch and ... Read more
Patient reports a rash at injection site that was first noticed today. Reports tender to touch and mild pruritus. Reports rash is localized to right upper arm and extends about 1 inch from injection site. Reports she felt a little "agitated" a couple of days post vaccination but cut down on coffee and issue resolved. Patient stated 2 days ago on Tuesday started feeling tired with cough and wheezing (denies asthma history). RN informed patient that respiratory symptoms are not a side effect of the vaccine and she should call her primary care doctor for an evaluation and testing for COVID-19 infection.
62 2021-01-15 excessive sleepiness, impaired work ability 38 hours post immunization severe L upper arm pain & mild local swelling, flu - like generalized ach... Read more
38 hours post immunization severe L upper arm pain & mild local swelling, flu - like generalized aches, fatigue, headache, elevated temperature (Tmax 100.0 oral) worsened over next several hours requiring relief from work duties. Ibuprofen 400 mg taken x 1 appropriately noon. Increased sleep over next 18 hours with complete resolution of symptoms except L arm pain which was reduced but took another 24 hours to fully resolve.
62 2021-01-16 feeling abnormal Upon awakening the morning after the vaccination, I experienced swelling in my ankles, feet and fing... Read more
Upon awakening the morning after the vaccination, I experienced swelling in my ankles, feet and fingers I also experienced swelling in my face where I had received filler injections six months ago. I also experienced feeling very spacey and foggy in addition to ringing in my ears, pins and needles all over my skin as well as a burning sensation on my upper back, buttocks and thighs. Finally, I felt extremely fatigued and lethargic. I had no fever or headache but had soreness at the injection site. I dosed with 600 mg of ibuprofen b.i.d. the first day as well as 50 mg of Benadryl at bedtime. While I got some relief from these medications, I still remain symptomatic on day two after receiving the vaccination.
62 2021-01-18 feeling abnormal, anxiety About three hours after I got vaccine I started feeling very tense and anxious. Next day I felt same... Read more
About three hours after I got vaccine I started feeling very tense and anxious. Next day I felt same, more less thorough the day. Three whole days later I feel same or even worse, so bad I cannot function. I feel like my body is producing too much adrenaline.
62 2021-01-20 insomnia Moderna COVID-19 vaccine EUA. Approximately 10 hours after the vaccine, severe chills, fever, heada... Read more
Moderna COVID-19 vaccine EUA. Approximately 10 hours after the vaccine, severe chills, fever, headache and inability to sleep. The symptoms subsided approximately 18 hours after onset.
62 2021-01-20 insomnia 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 2021-01-20 insomnia Started with itching and rash at injection site. Went away in 2 days. Next day palm of hands and sol... Read more
Started with itching and rash at injection site. Went away in 2 days. Next day palm of hands and soles of feet became very itchy. Then progressed to whole body itching. Unable to sleep for two nights. Went to urgent care next morning. Was prescribed hydroxyzine 25mg. Itching went away that night and was able to sleep. Next day bilateral hands had numbness and tingling and general dizziness so stopped taking hydroxyzine. Went to family practitioner and was prescribed methylprednisolone dose pack. After starting steroids, by 2nd day (today - 1-21-21), hands continued n/t. Bilateral feet developed n/t. Dizziness continues when standing but goes away when sitting. Balance and gait are unsteady. Difficulty walking from weakness, balance issues, and dizziness.
62 2021-01-21 feeling abnormal Had headache, fatigue, brain fog for 3 days also very sore arm. On day 8 after the vaccine my arm be... Read more
Had headache, fatigue, brain fog for 3 days also very sore arm. On day 8 after the vaccine my arm became red with an area the size of a silver dollar , below the injection site. My lymph nodes under my arm were swollen and sore and also lymph nodes above my clavicle on the right. I still feel fatigued and I have a full feeling around the area of my right upper abdomen ( liver), I dont have a gallbladder. Otherwise, I am OK. Just wondering about the 2nd dose. Lymph node still slightly swollen above clavicle.
62 2021-01-21 feeling abnormal Pain in left upper arm @ 7/10 with tenderness in lymph area, "brain fog", fatigue, dizziness
62 2021-01-21 loss of personal independence in daily activities, sleep disorder The following morning after receiving the vaccine you work around 6AM my arm was really sore and my ... Read more
The following morning after receiving the vaccine you work around 6AM my arm was really sore and my husband had to help me get dressed for work. I went to work and let my supervisor know my arm really sore. I left the office to go do my regular patrolling and started noticing that I had a really bad headache, and I went and got something to eat. I ate some cereal and I got nauseated and I kept getting some chills. I went back to the office to do some paperwork and when I tried to walk it hurt. I told my coworker told me to get get something warm on my stomach, I tried to it but it made it nauseated. I ended up leaving work early and going home laid down and have felt bad since. I can't not laid flat down as it uncomfortable, I propped myself up the bed. I have been up since 4am and have not been able to sleep since. I called the place where I received the vaccine at and they referred me to file a VAERS report. Had COVID in November 2020.
62 2021-01-21 sleep disorder, impaired work ability I woke up the next morning after receiving the vaccination and could not move my arm. My husband had... Read more
I woke up the next morning after receiving the vaccination and could not move my arm. My husband had to help me , I go to get dressed for work. I went to work and let my supervisor know that my arm was really sore. I went out to do my patrol and noticed a headache. I thought I needed to eat some I tried to eat some cereal. I became nauseous. I went back to the office to do some paperwork and when I tried to walk it was painful I told my coworker who suggested I need something warm on my stomach. I tired that but was to nauseous. I ended up leaving work and coming home and laid. I have cannot lay flat as it is uncomfortable and have myself propped up in bed. I have been unable to sleep since then. I previously had COVID in November 2020
62 2021-01-21 sleep disorder hi, I had tingling a few hours after receiving the first does of the modern vaccine, mostly in my ch... Read more
hi, I had tingling a few hours after receiving the first does of the modern vaccine, mostly in my chin, tongue and lips. I have since then had on and off nueropothy, from severe numbness and tingling throughout my entire body and head, to mild tingling, some of it being so severe, that I could not sleep. My general practioner has advised that I do not get the booster.
62 2021-01-24 feeling abnormal 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 2021-01-24 insomnia, feeling abnormal I started Sneezing on 1/19 at work and felt run down. I got a fever later that night had my throat... Read more
I started Sneezing on 1/19 at work and felt run down. I got a fever later that night had my throat was sore. Injection site was red and hot during my fever. fevers 101 at night and had trouble sleeping. I am better now. I got the first dose of the vaccine on 1/12/21.
62 2021-01-24 insomnia Mild achiness, nausea and loss of appetite, fever of 99.4 (my norm is about 97.6), headache, sleepl... Read more
Mild achiness, nausea and loss of appetite, fever of 99.4 (my norm is about 97.6), headache, sleeplessness, arm swollen and red. Lasted until about 3 or 4 am. Then fell asleep. Woke at 9am and all was gone except the arm.
62 2021-01-25 hallucination chills 6 hrs after inj, followed by hallucinations about 12 hrs later with increased chills and int... Read more
chills 6 hrs after inj, followed by hallucinations about 12 hrs later with increased chills and intense headache. Hallucinations lasted 2-3 hrs. Next morning all had resolved except extreme lethagy.
62 2021-01-26 confusional state, insomnia 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 feeling abnormal 1220- headache, feeling bad, drained energy and feels like jelly, came on all of a sudden. Checked b... Read more
1220- headache, feeling bad, drained energy and feels like jelly, came on all of a sudden. Checked blood pressure- 138/80 & 142/82, HR 74 and 85. Given water, encouraged to eat lunch, eating now. Walked back to classroom. Has someone in room with her. Checked on 10 minutes later, headache getting worse and feeling of being drained getting worse. Did take a dose of Tylenol.
62 2021-01-27 loss of personal independence in daily activities 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 feeling abnormal Felt "off" when I woke up. Pounding headache started at approximately 1:30 pm on 1/28/21, not helped... Read more
Felt "off" when I woke up. Pounding headache started at approximately 1:30 pm on 1/28/21, not helped with Advil. One bout of diarrhea. Headache finally eased late evening 1/28.
62 2021-01-28 feeling abnormal 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 feeling abnormal within about 5 min after getting shot my mouth , lips and tongue began to feel weird, Tongue swell... Read more
within about 5 min after getting shot my mouth , lips and tongue began to feel weird, Tongue swelled
62 2021-01-29 sleep disorder Muscle aches, body aches, unable to sleep,high fever ,nausea and vomiting, red hot rash at injectio... Read more
Muscle aches, body aches, unable to sleep,high fever ,nausea and vomiting, red hot rash at injection site
62 2021-01-30 sleep disorder Pain and swelling of upper arm increased over 2 days-was approx. 3 by 1.5 in., then decreased over n... Read more
Pain and swelling of upper arm increased over 2 days-was approx. 3 by 1.5 in., then decreased over next 5 days. Headache started 1st evening and continued for 2 days. Body aches started first night and increased over 2 days. Could not sleep 2nd night because of all these symptoms. Started Tylenol, first dose 24 hours after shot, second and third doses next day. Relieved headache and body aches. Started with a sore throat and swollen glands a week after dose, continuing now for 3 days.
62 2021-01-31 impaired work ability, loss of personal independence in daily activities shot at2pm by 5:15pm rt shoulder started hurting continued to get worse could not lift arm out rais... Read more
shot at2pm by 5:15pm rt shoulder started hurting continued to get worse could not lift arm out raise up nostrength inshoulder upper arm severe pain could not continue to work could not turn a light switch on pull open a fridge door screaming when trying to pullup my pants, screaming toget bra off &on shirt on by mon am could get dressed minimum pain armlesspain still no strength still can not reach out or up
62 2021-01-31 impaired work ability Fever, chills, headache, fatigue lasting approximately 36 hours. Missed work 1/27 and 1/28/21
62 2021-02-01 feeling abnormal 3 hours after shot severe pain around the injection shot Difficult to use the arm for the next 48 ho... Read more
3 hours after shot severe pain around the injection shot Difficult to use the arm for the next 48 hours very sore around injection sight About 8 hours after developed chills and tiredness and just was not feeling well 2nd day right arm still very sore and very tired general feeling of being unwell maliles by the 3rd day only felt more normal right arm only sore if you touched it or laid on it felt a little more energized. Then 02/01/21 exactly one week later had a strange feeling in my head not a headache not dizzy just felt an unusual feeling in my head of not feeling quite right especially with movement then 2 hours later had a ringing in my ears have no ear infection noting unusual im an RN and would report any other conditions. then that evening i began feeling itchy at my injection sight but i was just iching it though my clothes and wondered why i'm so itchy on my shoulder I really didn't think about the shot as it was 7 days later. The itchy feeling continued so I went to the bathroom took my shirt off and saw a rash which i will include pictures of the rash if I could. i was alarmed and concerned about the big rash and the papules sticking up. It's now the next day 02/02/21 I still have a big rash on my arm it's about 6 inches long 3 inches wide red elevated. I googled it and it said it was the covid arm or something. I am willing to provide pictures
62 2021-02-02 confusional state Fever 100.2; Extreme soreness at injection site; Joint pain; Confusion first night after injectio... Read more
Fever 100.2; Extreme soreness at injection site; Joint pain; Confusion first night after injection (not thereafter)
62 2021-02-02 impaired work ability Beginning at 2:45 AM my arm was painful and swollen. I woke up and my head started throbbing. then n... Read more
Beginning at 2:45 AM my arm was painful and swollen. I woke up and my head started throbbing. then nausea developed, chills, fever going from 99-102.6. Muscle and joint aches are terrible. I have been so sick all day and it is 10:00 PM. No relief in sight. Poor appetite. Dry skin. Gas. I missed work and have been in bed all day. I will will miss work tomorrow too. This is awful.
62 2021-02-02 sensation of foreign body Very sore arm, many aches , muscle in legs seemed to be fatigued, lymph nodes in neck very swollen f... Read more
Very sore arm, many aches , muscle in legs seemed to be fatigued, lymph nodes in neck very swollen felt like a not or small ball in throat when swollowing. Is this normal and if I get next shot will it be worse.
62 2021-02-02 sleep disorder 5 days post injection(19th) woke up in the middle of the night with arm pain in the deltoid area whi... Read more
5 days post injection(19th) woke up in the middle of the night with arm pain in the deltoid area which radiated under the arm and into the armpit. Deltoid swollen and firm but not hot. Pain increased the following day(20th) with more deltoid swelling and pain in the arm pit area. Redness noted at injection site size of a quarter the same day with tightness and pain when lifting the arm above the shoulder. Contacted primary care physician and spoke to RN regarding symptoms on the 21st. Redness increased and extended down the deltoid and bicep area. Itching began that day. On the 22nd the swelling subsided and by the 23rd the redness disappeared. Still have sensitivity in the deltoid area but swelling gone 4 Feb. Underarm and armpit pain gone by the 24th.
62 2021-02-03 impaired work ability The next day I was so sleepy , chill's and severe headache I had to leave work. Around 2:00 I was r... Read more
The next day I was so sleepy , chill's and severe headache I had to leave work. Around 2:00 I was running a low grade fever of 101. I went to sleep for until the next morning at 6:00am When I woke up my arm was very red and swollen below where I was given my injection. Today I'm still having headaches and feel very sleepy and very nausea.
62 2021-02-04 sleep disorder I had a positive Covid test 10/26/2020 with severe symptoms (every symptoms except SOB)that lasted f... Read more
I had a positive Covid test 10/26/2020 with severe symptoms (every symptoms except SOB)that lasted for 1 month until 11/27/2020. I received Moderna Covid vaccine on 12/31/202 @ 12:30 pm.in my left deltoid. Fifteen hours after receiving vaccine, I was awakened from sleep at 3 am with a pounding headache, this headache continued for days eventually shifting to the left side of my face and head with posterior neck spasms and pain. I had generalized mild body aches, and mild fatigue. 2 nights I woke from sleep completely soaked and had to change my clothes- I did not check my temperature ( the same thing occurred with Covid). Post vaccine: Left Arm very tender initially. On day 3, 1/2/2021, I developed increased pain, swelling with a warm ,red rash at the injection site on my left arm. By day 5 this area had greatly extended in size, warmth and tenderness. Day 6, the rash on my arm had disappeared and I am able to palpate a small lump with very, very slight tenderness at the injection site. I had a repeat Negative COVID test on 1/5/2021 I am continuing to have a dull sensation of pain on the left side of my face (as of 1/8/21), still with palpable spasms on the left posterior neck. All other symptoms have essentially resolved. I have not contacted allergist- wondering if I should before receiving 2nd Covid vaccine.
62 2021-02-06 insomnia Severe Headache, severe body ache, chills, dizziness, insomnia. Lasted12-15 hours. Body ache conti... Read more
Severe Headache, severe body ache, chills, dizziness, insomnia. Lasted12-15 hours. Body ache continued for over 24 hrs.
62 2021-02-06 insomnia None until 12 hours after injection. 12 hours later, Injection site became very hot, red and swoll... Read more
None until 12 hours after injection. 12 hours later, Injection site became very hot, red and swollen. Started with fever, chills, muscle aches, lethargic, unable to sleep, dreaming, Fever started at l00.6, then went up to 101.7 the next day. This lasted around 48 hours, fever is down to normal for the most, but my arm is still very red, swollen and hot. It is about the size of a baseball. My overall feeling is better, but not completely normal.
62 2021-02-07 impaired work ability Fever to 101.8 degrees and chills. Lasted approximately to 6 AM on 2/3/2021 and kept coming down. ... Read more
Fever to 101.8 degrees and chills. Lasted approximately to 6 AM on 2/3/2021 and kept coming down. On morning of 2/4/2021,Allowed to go back to work. Employee health would not allow to work until fever free for 24 hours
62 2021-02-08 impaired work ability, excessive sleepiness 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 2021-02-09 disorientation, feeling abnormal 2/2/21 Flu like aches: vomiting and diarrhea, fatigue and headache. 2/3/21 Nausea, disorientation, ... Read more
2/2/21 Flu like aches: vomiting and diarrhea, fatigue and headache. 2/3/21 Nausea, disorientation, and headache. Slept off and on. 2/4/21 Tiredness and headache. Took Benadryl 2/5/21 Body aches and fatigue. Foggy brain. Took Benadryl. 2/6/21 Sore throat, body aches, and fatigue.
62 2021-02-09 sleep disorder, impaired work ability Beginning 10PM (11 hours post vaccine) I experienced severe body pains and was unable to sleep. Cal... Read more
Beginning 10PM (11 hours post vaccine) I experienced severe body pains and was unable to sleep. Called out sick from work. Took 800 mg OTC Ibruprophin every four hours, which only reduced pain for an hour. Temperature went up to 102.1 morning of 02-09-21. Severe body aches and fever continued until 2:00am on 02-10-21, when the fever broke the body pain subsided as well. Overslept morning of 02-10-21, but was able to report to work an hour late. No side effects at this time, except for dull pain in site of injection.
62 2021-02-09 sleep disorder Diagnosed with Cellulitis of (L) upper extremity on 02/05/2021. Injection site red, hard , with bli... Read more
Diagnosed with Cellulitis of (L) upper extremity on 02/05/2021. Injection site red, hard , with blisters. Diffuse red, warm to the touch rash from one side of arm to the other. Arm painful, and itchy. Started on Cephelaxin along with Benadryl and Claritin D. Entire area was marked and traced by MD. Returned to MD on 02/10/2021 for intense itching, redness that spread past the tracings and also to the inside of the (L) arm which started on 02/09/21. The itchiness woke me up at 4 am on 02/10/21. Prescribed an additional antibiotic, Doxycycline and Betamethasone ointment. Area within the original tracing was less warm, blisters reabsorbed, but the new red areas were warm, and very red in color like a sunburn. MD took pictures at this visit. Scheduled to receive vaccine # 2 on 02/24/2021.
62 2021-02-09 sleep disorder Feb 4, 2021 - 7:35 pm - I received the Moderna Covid vaccine in my left arm. 9:00 pm - I started ha... Read more
Feb 4, 2021 - 7:35 pm - I received the Moderna Covid vaccine in my left arm. 9:00 pm - I started having bad arm pain Feb 5, 2021 - At about 1 am I had to leave bed to sit in a chair because it hurt too bad to lie down with my arm pain and I could not sleep. I continued to have bad arm pain all day. A cold wash cloth helped a little. I tried rubbing it, but that did not seem to help. It hurt so bad that I could not lift my arm over my head. Feb 6, 2021 - At about 6 am, I had a bad headache which continued all morning. At about 12:30 pm it became severe. I did not want to take any pain relievers in case they would interfere with antibody development. However, my head pain became unbearable so I took two Extra strength Tylenol at 1:20 pm. (This was about 30 hours after COVID shot. I was even concerned about having a stroke or other health problem due to extreme head pain.). By 2:00 pm I was feeling much better. The headache was gone by 6:00 pm without taking any more Tylenol. My arm pain was still there, but was a little better. Feb 7, 2021 - My arm pain was still there, but was a little better. It still hurt to raise my arm. Feb 8, 2021 - I only had minor arm pain. Feb 9, 2021 - Basically all better with just very minor arm soreness.
62 2021-02-11 nervousness 0946 Vaccination. Approximately 5 minutes after sitting in post vaccination area, began feeling shak... Read more
0946 Vaccination. Approximately 5 minutes after sitting in post vaccination area, began feeling shaky. Currenly recovering from chemo. Did not eat breakfast this morning and this is out of routine. Stated line was long. Reports to feeling similarly when she misses meals. 1000am BP 106/72 HR 78 R 18. Offered water and moved patient further away so she could eat the breakfast in her purse. Continued to feel better during the assessment. By 1100, reports feeling better. 1104 BP 114/72 HR 80. No complaints. Released to husband.
62 2021-02-12 insomnia, loss of personal independence in daily activities Immediately after I received the shot, I felt my whole left arm get very warm. Before going to bed ... Read more
Immediately after I received the shot, I felt my whole left arm get very warm. Before going to bed Wednesday evening, my arm began to hurt. Beginning at approx. 1:00 am after receiving shot, I got a headache which kept me up most of the night. The headache continued until Friday morning with taking Tylenol every 4 hours. Thursday other than my head hurting, my body hurt and I had a loss of appetite. Thursday evening I got chills, and ran a temperature. I was still taking Tylenol. I was able to keep my temp at bay only getting to 100.5 at the highest. Thursday night with all my pain, I did not sleep well again. My left arm hurt so bad and I was having a hard time letting it rest at my side. I realized my left armpit was swollen and down my left side to my breast I was very sore and tender. I woke Friday morning without a headache. I worked out at a gym on Friday but was not able to keep up with my usual routine. I still did not have an appetite but ate just for the energy. Food did not taste good. I had Covid in early November and lost my taste and smell. It returned so I'm not sure why food is not tasting good. It almost has a bland, metal taste if that makes sense. I felt like I was on the road to recovery only to run a temp again Friday evening. I got chills and knew what what was coming. No temp on Saturday as of yet. I do not have a headache which I am glad. My left arm still hurts but I am getting better range of motion. It is still very tender under the armpit area.
62 2021-02-15 feeling abnormal Vomiting, fever of 109, body aches, headache ache, fogginess, shoulder and throat hurts. Adverse rea... Read more
Vomiting, fever of 109, body aches, headache ache, fogginess, shoulder and throat hurts. Adverse reactions have lasted a week. Very fatigued.
62 2021-02-17 confusional state 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 2021-02-17 feeling drunk Pt was at work, reported "feeling drunk". Exhibited slight slurring of speech, jocular manner. Was... Read more
Pt was at work, reported "feeling drunk". Exhibited slight slurring of speech, jocular manner. Was unsteady on her feet, "not lightheaded really but more like I had a few shots... and I don't drink". Pt was kept under observation for approx 30m from reporting onset of symptoms to supervisor. Observed and interviewed at pharmacy. Pt's daughter was notified to come pick her up. Checked in with pt the following day, symptoms had resolved.
62 2021-02-17 insomnia Terrible myalgia & tight muscles in left leg, making it hard to sleep for several nights. It has bee... Read more
Terrible myalgia & tight muscles in left leg, making it hard to sleep for several nights. It has been worse at night or when my leg is straight; a little of same in right leg. Also some tingling in my leg down to my toes, and a few tingling spells on left side of face. Also stabbing pains? once in top of left foot & once in side of left leg. Treatment: ice packs and heating pad; a few doses of naproxen & acetaminophen which didn?t really help. It has been 2 weeks since my 2nd vaccination & I am still experiencing these side effects although they have lessened.
62 2021-02-17 insomnia First day of vaccine I experienced ache at injection site which I thought was normal until the next ... Read more
First day of vaccine I experienced ache at injection site which I thought was normal until the next day. The next day I noticed increased pain and when I checked my arm I noticed a red circle around the injection site in upper left arm about the size of a silver dollar. It feels hard underneath. That evening the pain increased and during night, sleep interrupted due to pain. Next day I experienced pain all day and in late afternoon, site began to itch. Red circle was somewhat larger. By the following night, the pain decreased and itching was minor. Today, redness is still there although faded and not as large. Pain and itching has also decreased.
62 2021-02-17 sleep disorder My arm had minor itching for the first several days, but on Wednesday (Feb 7, 2021) after the vaccin... Read more
My arm had minor itching for the first several days, but on Wednesday (Feb 7, 2021) after the vaccination (Feb 2, )2021, the itching intensified and was waking me up at night. I put some anti-itch cream on it and it would quit itching for a few hours. By Thursday, the itching was waking me up at night and by Friday afternoon, I had a half-dollar sized welt around the injection site that was very red, hard, swollen and feverish. We weren't in school Friday, so I didn't talk to our school nurse, and today is the first day back from snow days and she advised me to fill out this report. The site is no longer bright red or itching, but you can still see the faint outline of where the swelling was.
62 2021-02-18 sleep disorder Felt fine for first 12 hours. Went to bed. Woke up at 3am with chills and headache. Couldn't slee... Read more
Felt fine for first 12 hours. Went to bed. Woke up at 3am with chills and headache. Couldn't sleep. Got up at 5:30am. Fatigued. Went back to sleep until 9am. Feeling better. Lingering headache.
62 2021-02-19 feeling abnormal Same as my first shot feeling lethargic, exhausted, feeling ill, bad aches, feverish. Just all aroun... Read more
Same as my first shot feeling lethargic, exhausted, feeling ill, bad aches, feverish. Just all around don't feel good at all.
62 2021-02-19 feeling abnormal Pt assessed after receiving COVID-19 vaccination drive thru site. She reported onset of mild lighthe... Read more
Pt assessed after receiving COVID-19 vaccination drive thru site. She reported onset of mild lightheadedness and a non-specific "funny feeling" in her head. No vertigo or presyncope. No other new neurologic changes such as vision changes or extremity weakness. No chest pain, palpitations, dyspnea. No other signs of allergie/anaphylaxis (ie rash, throat swelling, GI side-effects). She reports hx of high blood pressure and is on one BP medication but cannot recall the name. States she took it today. Reports eating breakfast this morning. Exam notable for BP 140/85, HR 60. Pt well-appearing, no acute distress, no obvious CNS or peripheral deficits. RRR, normal s1/s2, no m/r/g. Lungs CTAB. No obvious rash or facial swelling. During course of evaluation pt reported symptoms improved but did not quite resolve. Advised pt to continue monitoring at vaccination site for additional 15 minutes. Offered juice, crackers, fluids which she declined though did drink some of her own water. Upon reassessment pt reported continued improvement though symptoms had not completely resolved. Offered to have EMS come assess pt though she declined. Warning signs/symptoms discussed with pt for when to seek out care at ED. She is in agreement.
62 2021-02-20 disturbance in attention Got headache that felt like the one had with covid. Headache was a 10+ and fever reached 101.9 als... Read more
Got headache that felt like the one had with covid. Headache was a 10+ and fever reached 101.9 also had fatigue and I had trouble concentrating. All medications I had did not work. So I called my Doctor and they recommended I go to ER. I went to ER and was given the following medications dexamethasone 10%, Dextrose5% 50ml, diphenhydramine 50mg, metoclopramided 10 mg, ketrorolac 15 mg all medication given intraveneous.
62 2021-02-21 poor quality sleep I developed chills/shivering in the evening of the vaccination (2/19/21) but was not alarmed, just t... Read more
I developed chills/shivering in the evening of the vaccination (2/19/21) but was not alarmed, just tried to stay warm. I ate normally. I awakened in the night with extreme chills and was shaking most of the night, unable to get warm. I felt feverish and had body aches as well as nausea. I threw up what I could to alleviate the feeling of nausea, about 2 a.m. I slept restlessly until 9:00 am, then tried to take a hot shower. Though the chills were gone, I felt weak and listless and went back to bed shortly after showering. I slept for about 4 hours. I had little/no appetite for most of the day after the vaccine. By the second day I still had a headache but felt better, albeit weak. I took Ibuprofen for the body/headaches with minimal success.
62 2021-02-22 feeling abnormal Approximately 6 hours after receiving the injection I started running a temperature of 102.7 and fee... Read more
Approximately 6 hours after receiving the injection I started running a temperature of 102.7 and feeling absolutely terrible all over. Shortly there after I was having such sharp pains in my joints (pretty much all over) that I couldn't get out of a chair without much assistance. Then I couldn't walk only barely shuffle y feet with my husband holding onto me. I was very short of breath at this point with a pulse ox reading starting at 76 and finally reaching 88, but would not climb any higher. I was very nauseous and unable to eat or drink. The following day my temperature was still running 101, but not continuously. I still felt bad, but could shuffle walking without assistance and was still nauseous. I pretty much stayed in a recliner chair all that day, except to try to take a shower, which I really had a feeling I wasn't going to survive. I went to bed without dressing, because felt so bad. The next day I felt better, but was so short of breath I had to have a rolling chair to sit in to try to do something in the kitchen. By afternoon February 15, 2021 I was feeling better, Only shortness of breath when walking and my pulse ox was 92. Should I take the second Moderna vaccine?
62 2021-02-22 feeling abnormal Within 1-2 minutes, felt like an infusion or flush with a chemical/metallic smell, taste. Extreme we... Read more
Within 1-2 minutes, felt like an infusion or flush with a chemical/metallic smell, taste. Extreme weakness, dizziness. Had to sit down for a long time, couldn't really open my eyes. Bad head feeling. Eyes hurt, but were not swollen. No swelling, just that constant metallic overwhelming. Dizzy. Stayed at pharmacy for about 40 minutes. On drive home, hot face, metallic infusion, very warm. Fever at home, achy all over, 99.8, very dizzy, brain fog, very weak, arm sore. Next morning, no better. Took a Nexium and immediately big hive popped up on my chest. Disappeared about an hour later. Took 3 days to feel like myself. Still concerned about allergic reaction. I'm a little itchy, tingly. I'm now terrified of getting that second shot.
62 2021-02-22 insomnia Heart flutters , sore arm , trouble sleeping
62 2021-02-24 anxiety 9:24 am -Client felt a little lighthead, no SOB or difficulty breathing no dizziness not complaint o... Read more
9:24 am -Client felt a little lighthead, no SOB or difficulty breathing no dizziness not complaint of feeling that throat was closing, no N/V, no clamminess or diaphroesis observed P-68 P 20 9:27 am- no longer feeling lightheaded, no flushing, she reports no history of allergies or allergic reaction that require an epipen. She advised "it may be anxiety"p-68R-22 9:32 am-complained of they feeling had return she felt tingling in her neck and arm and feeling lightheaded lasting briefly less than 1 min P-80 R-22, no dizziness, no difficulty breathing, no feeling that her throat was closing, no N/V, or clamminess observed 9:54am EMT on site, responded no epipen needed, EMT took over. Client left POD at 9:54 no rescue
62 2021-02-24 depression Rapid heart rate, chills, aches, sweats and severe depression.
62 2021-02-24 feeling abnormal 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 loss of personal independence in daily activities, impaired work ability Described previously-took OTC medication
62 2021-02-25 feeling abnormal first day i was fine and the 3nd day i had high fever 101.8 the whole day. my head ached, the 2nd... Read more
first day i was fine and the 3nd day i had high fever 101.8 the whole day. my head ached, the 2nd day my fever went down to 99 later in the day and then my head still ached though and the weird thing the 3rd day my temp went down to 95.5 for a while then it went to normal the same day all 3 days i was very tired and weak
62 2021-02-25 sleep disorder Started noticing soreness in my left arm late on 2/25/2021, similar to what I had the next day after... Read more
Started noticing soreness in my left arm late on 2/25/2021, similar to what I had the next day after my shot. It got worse during the night, couldn't lay on that arm all night, and on awakening my arm was very painful, red, hot with a large lump.
62 2021-02-26 insomnia DAY: 1-2 SORE ARM AT INJECTION SITE. 3-5 : Chills and sweats, flu like symptoms. 6-7 : Swelling of ... Read more
DAY: 1-2 SORE ARM AT INJECTION SITE. 3-5 : Chills and sweats, flu like symptoms. 6-7 : Swelling of extremities general fatigue. 7: difficulty walking, went to urgent care low fever 100.2 , tested for covid -negative, lungs and heart sound good , prescribed zyrtec, benadryl, pepsin and tylenol if necessary. 8-15 : continued swelling, low appetite, difficulty sleeping ( due to discomfort in entire body) fatigue 15: Increased swelling, neck back and legs very stiff and sore.I continue to follow recommendations on over counter aid.
62 2021-02-27 anxiety 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 anxiety 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 2021-02-28 insomnia Following my second dose of Moderna Covid 19 vaccine on 2/13/21 I experienced a significant reaction... Read more
Following my second dose of Moderna Covid 19 vaccine on 2/13/21 I experienced a significant reaction to the second dose: My temperature rose to 102 with headache and arthralgia throughout body that prevented sleep. I was in bed for more than 24 hours due to lightheaded/dizzy/nausea when standing. I fell once when getting back into bed due to loss of balance. Severe symptoms started 15 hours after receiving the dose and lasted approximately 36 hours post dose when my temperature then returned to normal. The next 1-2 days, while I no longer had a fever and symptoms were improved. I was still fatigued and did not feel fully recovered. Treatment during the severe symptoms included rest, icepack to head, Tylenol or Ibuprofen slightly decreased temperature for a brief periods. I informed my physician's office Dr, of the above reaction and was told to file a VAERS report.
62 2021-03-03 anxiety C/O numbness around lips, able to stick tongue out and move, no discoloration around lips, able to ... Read more
C/O numbness around lips, able to stick tongue out and move, no discoloration around lips, able to talk without difficulty, pt states at 13:15BP 150/90 Hr 71 Spo2 100, 13:30 BP 154/105, HR 74 Spo2 100 13:35 that she feels anxious and will take her anti anxiety meds at home. instructed to F/U with PCP.
62 2021-03-04 anxiety 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 2021-03-07 impaired work ability I received the Moderna vaccine on Wednesday, 03.03.2021 @ 1:00 pm. At around 3:00 am I woke up thro... Read more
I received the Moderna vaccine on Wednesday, 03.03.2021 @ 1:00 pm. At around 3:00 am I woke up throwing up and having diarrhea. I could not even hold water down and just kept throwing up and having diarrhea until after 8:00 am Thursday morning. I had chills so bad to where I was shaking and my fever went up to 103 F. I was in bed all day and could not go back to work on Friday due to still having high fever. By Friday evening, my fever finally broke; however, my started getting red and swollen. It just kept getting redder in a larger area. It is very red today and this is five (5) days after the shot.
62 2021-03-08 excessive sleepiness, feeling abnormal Felt " off" on Monday evening 3/1/ 21 light headache. Tues. 3/2 4:am. Woke to severe dry heaves... Read more
Felt " off" on Monday evening 3/1/ 21 light headache. Tues. 3/2 4:am. Woke to severe dry heaves, chills, sweating, and headache. Dry heaves would last 5/ 7 minutes, and then severely tired. Sleep for 2 hours, then repeat all day on Tuesday. slept a total of 20 hours. Wednesday: I could control the dry heaves, Worse headache that ibuprofen couldn't control. Drank fluids and slept another 20 hours. Thursday: Improvement , still had headache, sweating and chills, no dry heaves. Slept 15 hours. Fluids and toast. Friday to present. Still tired, but recovered
62 2021-03-09 feeling abnormal Lost of balance Dizziness throughout the day Unstable Unbalanced Headaches
62 2021-03-09 loss of personal independence in daily activities, impaired work ability A 63-year-old female with a medical history of Hashimoto?s Disease, on Levothyroxine 88 micrograms (... Read more
A 63-year-old female with a medical history of Hashimoto?s Disease, on Levothyroxine 88 micrograms (4 days per week) and 100 micrograms (3 days per week), presented to the emergency department with a 7-day history of acute onset of severe, debilitating, fatigue, weakness, anorexia and malaise. She had no clear precipitating events, stated that she was in her usual states of health, active, working as an optometrist at a University hospital. Stated that 1 week before symptom oncer she had her first dose of Moderna COVID-19 Vaccine EUA. Stated that 24hrs later her symptoms started associated with low grade subjective fever, however her fever disappeared, and she persisted with severe fatigue. She was unable to do her regular activities of daily living and was hoping her symptoms would resolve but upon persistence and given the severity of her complains she presented to evaluation. She denied recently starting any new medications/supplements, or recent change in her levothyroxine dose. There were no headaches, cough, diarrhea, sore throat, rhinorrhea, myalgia, arthralgia, weakness, recent infectious illness or sick contacts. She was diagnosed with Hashimoto?s Disease over 10 years prior and had been on the same dose for more than 2 years. VS were stable and within normal limits, physical exam was only remarkable for weakness on 4 extremities 4/5, lethargy, bradylalia, bilateral ptosis, no focal neurologic deficits, sensation intact. Laboratory workup revealed normal Hb 14.8, normal renal and kidney function, normal cortisol level, TSH normal 3.7, normal FT4: 1.2, normal CPK, negative tox screen. ESR and CRP were performed, and both were found to be elevated ESR 74, CRP 28, at that moment we decided to do immunologic workup showing high titers of ANA >1:320 with a nuclear speckled pattern, and a positive rheumatoid factor 60. At this point a full rheumatologic panel was performed which was negative for anti-Ach receptor Abs, negative anti-CCP, anti- dsDNA, anti-smith, negative anti-Jo1, anti-RNP, negative anti-TPO, negative anti-SCL70, normal C4 and C3 however elevated total CH50 > 60, positive anti-SSA and anti-SSB. Her symptoms of severe fatigue persisted throughout her admission and it was decided to give her a course of prednisone 40mg for 5 days and follow up as outpatient with a Rheumatologist. Repeat workup 2 weeks after discharge showed still elevated ESR at 72, high CRP 17, rheum factor elevated again at 67. At this point no clear cause was identified as she did not have any symptoms of Sjogren or anything else other than severe persisting fatigue. Another course of steroids was given and 1 month later she stated that she was much improved and was able to go back to work. Stated that she would not take her second covid MODERNA vaccine dose due to fear of recurrence of symptoms. It appeared that this vaccine triggered a severe inflammatory and autoimmune reaction in this patient with history of Hashimoto?s disease. The association between MODERNA vaccine and development of autoimmunity and inflammatory reaction needs to be assessed.
62 2021-03-10 restlessness Had the ?normal? slightly sore arm (less than the 1st one) that evening BUT I was started to feel mo... Read more
Had the ?normal? slightly sore arm (less than the 1st one) that evening BUT I was started to feel more a bit more achy overall at bedtime and applied topical pain ointment. Was woken up at 1AM by wide spread discomfort spots in entire body..sort of flu?ish, but with several ?heavy?/intense/crampy areas of pain ALL in my back & various muscle groups in the legs. Took OTC pain reliever and applied more topicals. Noticed I kept having chills, but no fever through out the restless, painful night. This continued ALL weekend...at one point I felt I was at a 8-9 level, in tears, even after taking many OTC antiflammitories (that I normally avoid to protect my long term health)and then with some old muscle relaxer (skelatin) & pain (tramadol) ?scripts that I dug up. My left arm was also very swollen, rashy red & hot. By that Monday (2/15), I was a bit better & was able to stop the ?Scripts & drive myself to my pain specialist for my monthly appt? Dr. was surprised to find so much stiffness/inflammation in my body and worried about my arm. She was able to treat it and my poor body and I felt a bit more doable for a couple of days....but my back always stayed very stressed/strained! It eventually went out on me ??and I have remained in terrible pain for 4 weeks now?with ~20 Trigger spots all over body?bizarre!!!M
62 2021-03-11 abnormal dreams, feeling abnormal Approx. 20 hours after 2nd dose: Woke up feeling nausea, fatigued, fever, chills. After 1 episode ... Read more
Approx. 20 hours after 2nd dose: Woke up feeling nausea, fatigued, fever, chills. After 1 episode of nausea, I started experiencing more than mild muscle cramps. Could not lay on either side. Darkened room because light/ sound was adding to already severe headache. Used cold washcloths on forehead. Was having trouble trying to walk, use restroom, frequent urination but could only sip water. Over the next 24 hours...just slept and used bathroom. Severe muscle cramps, chills, fever, headaches. Called my Dr.'s nurse-she advised to hydrate and to go to ER if needed. 24 hours later, I realized I would be okay...but took me another 24-36 hours to feel 80% normal. Lost 8LBs. during 48 hours. Experienced extreme dreams/delusions.
62 2021-03-11 disturbance in attention 11:30pm. Woke up itching around my mouth and nose, and it quickly went to my scalp, back, shoulders.... Read more
11:30pm. Woke up itching around my mouth and nose, and it quickly went to my scalp, back, shoulders. I've been through this many times before, so took 25 mg Hydroxyzine HCL, sat in a very hot tub, and went back to bed. Next day feverish, which is likely the shot. Total lack of focus, ability to function was likely the Atarax. (Hate the stuff, but it works.). 2nd day: feverish, achy joints, and some ability to focus, but overall not a productive day. I went into this shot with a completely clean diet of things I know I can tolerate, exercise, lots of liquids. I will add acupuncture before and after the next shot.
62 2021-03-12 nervousness Around 3:30pm the day after injection I felt queazy with stomach tightness. Tested blood sugar. I... Read more
Around 3:30pm the day after injection I felt queazy with stomach tightness. Tested blood sugar. It was 78.--technically not dangerously low but low for me. Drank a non-diet Sprite. Physical discomfort went away. Felt tired. Fell asleep for 2-3 hours. After officially going to bed I woke up approx 2:30am feeling light-headed and shakey which is typical reaction when my blood sugar is too low. Tested blood sugar. It was 54. Ate 7 life saver candies and went back to bed. The next day (second day after injection) around 3:30pm felt hot which is another typical reaction when my blood sugar is low. Didn't test blood sugar but ate 7 life saver candies. Then I felt better and continued on with my day.
62 2021-03-14 nervousness After taking Moderna Covid19 vaccine, I felt heat all around my body ,and nausea. I feel nervous ,an... Read more
After taking Moderna Covid19 vaccine, I felt heat all around my body ,and nausea. I feel nervous ,and just not good .My vaccine was at 12pm ,and symptoms started right after.
62 2021-03-16 excessive sleepiness March 3rd I had chills for about 4-6 hours. My arm was sore for 3 days. March 4th, I had a headach... Read more
March 3rd I had chills for about 4-6 hours. My arm was sore for 3 days. March 4th, I had a headache & felt like I had a head cold with sneezing and stuffy nose. My right ear was itching. I had bouts of chills that lasted 4-6 hours that day as well. March 5th I had another bout of chills that lasted about 4-6 hours. On March 6th, I had intense fatigue and slept the entire day and night. Then on March 15th, I broke out in a big rash on my left arm where the 1st vaccine was given and around my stomach. My arm was very sore, was hot to the touch and very hard. On March 16th, it was still very red, super itchy and hot to the touch. My doctor told me to take antihistamines and Advil. She never actually saw me nor looked at my arm. She stated it was "normal" and I should have the 2nd vaccine. However, today my arm is the same or slightly worse. There is less itching, likely from the antihistamines and cortisone cream. My friend told me I should report this and should reconsider getting the second dose, given my history of severe reactions.
62 2021-03-16 impaired work ability patient experienced severe dizziness, lightheadedness, nausea, diarrhea & chills. She was unable to... Read more
patient experienced severe dizziness, lightheadedness, nausea, diarrhea & chills. She was unable to work for 3 days due to the mentioned side effects
62 2021-03-17 insomnia High level or soreness in left arm Muscle and joint soreness similar to what I experienced with hav... Read more
High level or soreness in left arm Muscle and joint soreness similar to what I experienced with having Covid 3 months prior especially fine motor muscles and joints Very tired but unable to sleep the first night
62 2021-03-18 feeling abnormal After client completed 15 minute waiting period, she reported feeling "fuzzy" upon standing. Further... Read more
After client completed 15 minute waiting period, she reported feeling "fuzzy" upon standing. Further described as lightheadedness. Also reported HA that started at nape of neck and extended to forehead. HA described at "dull." Pain 2-3 on 0-10 pain scale. VS assessed. 140/90. Pulse 76. Continued assessment. By 1040 reports pain 3-4/10, but pain only located at left side of forehead. Reports feels much better, besides the HA. Felt well enough to leave. Escorted to car--daughter present and driver.
62 2021-03-18 loss of personal independence in daily activities 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 2021-03-19 feeling abnormal 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 2021-03-19 insomnia 6 days after vaccination, a red sore rash appeared on my left arm, approx 3 inches below vaccination... Read more
6 days after vaccination, a red sore rash appeared on my left arm, approx 3 inches below vaccination site. Rash spread to an area of approximately 5? wide and 4? high and is swollen hot, itchy and uncomfortable and persists today, 10 days after vaccination. At the same time as the rash appeared I began to have sleepless nights, waking 2 hours after going to sleep every night and spending the rest of the night waking every hour. I had no symptoms, apart from a sore arm, until the 6 day point.
62 2021-03-20 confusional state Pain at skull base and vertigo almost immediately after injection. Muscle and joint pain for 36 Hour... Read more
Pain at skull base and vertigo almost immediately after injection. Muscle and joint pain for 36 Hours after injection. Vertigo continued, on and off for 48 hours after injection. Confusion (brain fog) for 48 hours after injection. Low ow grade fever (99.1 with no touch thermometer) for approx. 72 hours after injection.
62 2021-03-20 nervousness, feeling abnormal, fear 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 2021-03-20 sleep disorder Severe migraine like headache, prevented sleep for several hours. Nausea and vomiting, bruised face.... Read more
Severe migraine like headache, prevented sleep for several hours. Nausea and vomiting, bruised face. Fatique lasting 2 -3 days.
62 2021-03-21 euphoric mood Severe pain (nerve type) that began at 10 pm following injection. First injection felt like it was ?... Read more
Severe pain (nerve type) that began at 10 pm following injection. First injection felt like it was ?grabbing? my arm, different feeling than typical vaccine soreness. First vaccine, kept working on moving arm and was able to overcome. Did have Covid arm beginning on day 8, a nuisance only. I?m known to my physicians as strong, stoic, and have high tolerance to pain. Pain radiated from shoulder through the end of my fingers. Felt like battery acid, and shocking feeling, pure nerve pain. On scale of 1 to 10, pain was 10 most of the night, 8 at best. I avoided NSAIDS as recommended. Finally took 1/2 tramadol at 7 am, totally immobilized arm with blankets and towels, used medical grade ice packs to control the pain. Pain was significant days 2 and 3 (probably 8), little better third morning. Suddenly at 4:30 this afternoon, most of pain left suddenly. As being a tough woman, this pain was horrid. It was similar to having shoulder surgery when the nerve block ?runs out?, without narcotics to get through the pain. It may have been a high IM injection, but yes 3 fingers down from acromion. Felt high
62 2021-03-21 impaired work ability First shot was Feb 5. One week later my side effects started. Headache, Fever (102), chills, body ... Read more
First shot was Feb 5. One week later my side effects started. Headache, Fever (102), chills, body aches. Started on Friday Feb 12 and ended on Sunday Feb. 14th. Second shot was Fri. March 5. Immediate reaction this time with overnight chills and fever. Fever never getting over 100. Body aches, headache. It was over by Sunday late in the day. I then got a second reaction on Thursday March 18, 2021. I left work at 10:30am with a fever starting. I got a 103 degree fever on Thursday and Friday. Had all the same symptoms, Headache, body aches, joint pain, high fever. Saturday I went to urgent care to rule out anything else. He said it was probably from the vaccine. Fever was finally starting to get lower and I felt ok on Sunday morning but the fever came back to 101.4 by the afternoon. I have also experience numerous episodes of night sweats. Waking up randomly soaked in sweat. Today I came to workbut I am weak and tied. This morning was a fever of 99.8.
62 2021-03-21 loss of personal independence in daily activities 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 2021-03-22 hallucination Tested positive for COVID 19; Hallucinating; Body aches; Fever; A spontaneous report was received fr... Read more
Tested positive for COVID 19; Hallucinating; Body aches; Fever; A spontaneous report was received from a consumer concerning a 62 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed body aches (myalgia), fever (pyrexia), hallucinating (hallucination) and tested positive for covid 19 (SARS-CoV-2 test positive). The patient's medical history was not reported. Concomitant product use was not reported. On 04 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 06 Mar 2021, approximately 2 days after receiving vaccine, the patient developed body aches, fever and hallucinating. On 07 Mar 2021, the patient tested positive for covid 19. Treatment information was not reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events 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. However, the mRNA-1723 does not contain virus capable of causing infection and with the occurrence of SAR-COV-2 test positive after vaccination, is unlikely related to mRNA-1273.
62 2021-03-23 impaired work ability, disturbance in attention Sedation, Myalgia, UrticariaPruritus, Decreased concentration Narrative: After 1st dose on 2/16/2... Read more
Sedation, Myalgia, UrticariaPruritus, Decreased concentration Narrative: After 1st dose on 2/16/21 noted arm soreness and myalgias, and felt random prickling sensation in body. Received 2nd dose 3/16/21 and noted onset of prickling sensation with 2 hours, which lasted through 3/18/21. Noted myalgias the night after injection. Felt feverish during the night, but did not check temperature. Pt awoke the next day with hives on the non-injection arm - which resolved after 3 hours. Also noted fatigue and decreased concentration. Missed work x 1 day. No known prior covid infection.
62 2021-03-23 impaired work ability I got the chills, layed down and tried to warm up. My left arm is in pain. fell asleep briefly, woke... Read more
I got the chills, layed down and tried to warm up. My left arm is in pain. fell asleep briefly, woke up to extreme stabbing pains in the right temple of my head. I barely could walk to the bathroom and I layed on the floor because of the pain in my head. I can feel the pulse of my heartbeat in my head. I had intense nausea. I managed to get to bed. I drove to work the next day but my boss sent me home because I was the same. My eyes feel like they are flickering and are in pain. I feel like its a nerve in my eyes that are messing with me and are very painful. I am afraid to take the second shot.
62 2021-03-23 sleep disorder 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 2021-03-25 abnormal dreams 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 insomnia Fever , sleeplessness, overall lethargic
62 2021-03-25 loss of personal independence in daily activities Fever of 102 early morning 25th Right hand wouldn?t work, like it fell asleep but wasn?t numb, for a... Read more
Fever of 102 early morning 25th Right hand wouldn?t work, like it fell asleep but wasn?t numb, for about a minute. I felt like I was in another world. The morning of the 26th. Rash on my back near tailbone mid day 26th
62 2021-03-26 feeling abnormal 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 2021-03-26 loss of personal independence in daily activities Symptoms: I started running a fever - 100.4 degree F- around 11:00pm, accompanied by severe body a... Read more
Symptoms: I started running a fever - 100.4 degree F- around 11:00pm, accompanied by severe body aches and headache. The fever lasted for about 12 hours- then was just low grade 99.8 ( my normal temperature ranges between 96.8 and 97.6). Muscle aches and headache persisted until the morning of March 27th. Treatment: I pushed fluids, took Ibuprofen 400 mg every 6 hours, and stayed in bed (I was scheduled to work at the Hospital (I am a RN and work on the Family Birthing Center at our local hospital), but called off work). All symptoms are listed as side effects.
62 2021-03-27 feeling abnormal Feeling like the worst flu I've every had, body aches , muscle cramping, pinching in my stomach, at... Read more
Feeling like the worst flu I've every had, body aches , muscle cramping, pinching in my stomach, at first. Then fever of 102* 2:00 am on 3/26/2021. Took tylenol extra strength without much relief. Waited 6 hrs and took one Advil. Had fever around 101* most of 3/26/2021. At 8:30 pm fever spiked to 103*9 (Braun digital/ear thermometer). Took two Advil and waited 1 hour, fever started to come down. 3/27/2021 Fever back to 101* 9:00 am 102* by 12:00 took 2 more Advil. Nausea, aches and headache feeling bad most of the day. This is well over 48hrs at this point. This am 3/28/2021 woke up with 99* hoping I recovering.
62 2021-03-28 feeling abnormal Felt bad upon awakening, on Saturday morning (3/27/21) left arm sore at injection site and in joint ... Read more
Felt bad upon awakening, on Saturday morning (3/27/21) left arm sore at injection site and in joint of left shoulder and elbow, developed fever of 101.5, took acetaminophen and returned to bed. Fever broke about 8 pm, awoke Sunday felling drained, tried and sore all over.
62 2021-03-28 feeling abnormal 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 insomnia 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 feeling abnormal No symptoms day of. Woke 4:30 AM on 3/31, headache and chills, no fever, sore left arm. Took IB 8... Read more
No symptoms day of. Woke 4:30 AM on 3/31, headache and chills, no fever, sore left arm. Took IB 800. Started to feel better, later in the afternoon however, 3:00 PM sore throat swollen glands, low-grade temp 99.8, foggy brain. That is where I am at this time.
62 2021-03-30 feeling abnormal 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 impaired work ability, loss of personal independence in daily activities Initially sore arm next day. 30 hours after, extreme fatigue. 36 hours after, stomach pain and sev... Read more
Initially sore arm next day. 30 hours after, extreme fatigue. 36 hours after, stomach pain and severe nausea. On day 14, I started taking Zofran for nausea Nausea has lasted for 2 weeks, impacting ability to work and do normal daily tasks, intermittently .
62 2021-03-30 sleep disorder Severe itching and bumps on my back. Started itching about 7 hours after shot and continued for abo... Read more
Severe itching and bumps on my back. Started itching about 7 hours after shot and continued for about 18 hours. Could not sleep. Almost the same reaction that I have with hydrocodone.
62 2021-03-31 mental status changes 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 2021-03-31 sleep disorder Sore arm, general fatigue and in the middle of the night I felt chills and feverish but was able to ... Read more
Sore arm, general fatigue and in the middle of the night I felt chills and feverish but was able to go back to sleep.
62 2021-04-01 feeling abnormal First Dose of Moderna on 3-3-21: Dizzy and lightheaded within the 15 minutes for the wait time at f... Read more
First Dose of Moderna on 3-3-21: Dizzy and lightheaded within the 15 minutes for the wait time at facility. This feeling continued for 3 hours post-injection. 2 Hours after injection, more fatigued than normal and that continued until early evening. Arm pain lasted 2 days. Second Dose of Moderna on 3-31-21: Extreme fatigue began 7 hours after injection. 13 hours post-injection, awoke to extreme severe arm pain, slight headache, slight, but fleeting chills, skin extremely sensitive and hurt like with the flu, sore glands in throat, off and on sweating , severe joint pain in knees, elbows, shoulders, toes, back and neck, felt foggy minded. These symptoms lasted until the morning of 4-2-2021. 4 Advil every 6 hours helped to alleviate aches somewhat.
62 2021-04-01 feeling abnormal Client reports painful, white sores in her mouth and on her tongue, beginning on 2/27 and lasting fo... Read more
Client reports painful, white sores in her mouth and on her tongue, beginning on 2/27 and lasting for about "10 days after." She did not take her Orencia for RA on 2/27 due to these symptoms and reports that by 3/3/21 (Wednesday), "I was having a full blown flare of my RA with joint pain and fatigue; I noticed the worst symptoms in my wrists and hands." This prompted patient to take her Orencia on 3/3 that week. Due to the mouth sores, she increased her acyclovir (Zovirax) to 400mg BID. Client reports that after her 2nd dose on 3/24, she developed a "severe headache" the next day with worsening of "just feeling really bad" noting that mouth sores returned on 3/27/21 and that on 3/28/21, "I woke up with something that felt like a bug bite on my left side" described as in the area of her lateral trunk region. She states, "I saw my RA doctor on 3/29 and was diagnosed with Shingles. She has prescribed Valtrex 1g TID on 3/29 and I still have the rash."
62 2021-04-02 feeling abnormal Lasted approximately 36 Hours. I had cold chills through the night. When I awoke on 4/2/21 I didn'... Read more
Lasted approximately 36 Hours. I had cold chills through the night. When I awoke on 4/2/21 I didn't want to get up. When I got up felt foggy and groggy, kind of a strange feeling and had a headache. Really didn't want to do anything. Around 9:00 AM on 4/2/21 I took 2 ibuprofen and felt better until around 2:00 PM. Around 2:00 PM I just ached all over in my wrist, lower back, just felt terrible. I couldn't seems to get warm. I was chilled all day. I took 2 more ibuprofen on 4/2 at 7:30 PM and went to bed. Sleep all through the night without waking and got up at on 4/3/21 at 6:45 AM and felt like a new person
62 2021-04-04 confusional state 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 2021-04-05 impaired work ability Extremely painful right upper arm starting 6 hours after vaccine lasting 5 days. Ongoing fatigue ev... Read more
Extremely painful right upper arm starting 6 hours after vaccine lasting 5 days. Ongoing fatigue ever since vaccine. Did not have fatigue previously. Interferes with job performance. Nap every weekend multiple times, and sometimes as soon as I come home from work. Going to bed about 1.5 hours earlier than usual and wake up exhausted.
62 2021-04-06 confusional state 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 feeling abnormal Indigestion, arm pain, fuzzy head
62 2021-04-06 impaired work ability Injection site pain lasted 3 days, on the 4th day pt experienced headache which worsened over 2 days... Read more
Injection site pain lasted 3 days, on the 4th day pt experienced headache which worsened over 2 days and on 3rd day began with painful stiff neck which has lasted for a week, although getting better. No other injury or illness to account for these symptoms. Pt was unable to drive for most of the week and did miss some time at work.
62 2021-04-06 loss of personal independence in daily activities Patient reports that a headache started the evening of the vaccine. She has experienced daily heada... Read more
Patient reports that a headache started the evening of the vaccine. She has experienced daily headaches since then. They usually occur in the afternoon around 4:00 PM and interfere with her daily life. She often has to stop what she is doing for the day. Patient has an appointment with a neurologist to discuss her ongoing migraines and if the vaccine is related to them.
62 2021-04-07 disturbance in attention Soreness at sight of injection followed by chills, fever, muscle and joint aches throughout body. S... Read more
Soreness at sight of injection followed by chills, fever, muscle and joint aches throughout body. Shakes and intermittent hot flashes and nausea accompanied by stuffy head, inability to concentrate. Excessive yawning and need to stretch legs frequently. These symptoms still present at 8:15 p.m. on 4/8/21, with exception of yawning.
62 2021-04-07 excessive sleepiness Had vaccine at noon on 4/5. Worst headache I have ever had in my life except for once when I had th... Read more
Had vaccine at noon on 4/5. Worst headache I have ever had in my life except for once when I had the flu with a fever 21 years ago- headache began in middle of night on 4/6. I had sensitivity to light ( never had that before) slept intermittently for about 36 hours, took no pain meds because pharmacist said to try not to, if I had a reaction. I did not take zolpidem tartrate second night ( I took 1/2 a pill the first night before I really knew I was having a reaction) Drank lots of water as supposed to keep hydrated. Had significant chills, but no fever, for first 24 hours after symptoms began. Was confined to bed for a day and a half. Headache had improved by morning of 4/7, and resolved by evening of 4/7/21.
62 2021-04-07 impaired work ability I was very dizzy when I woke up on 3/18/2021 (one week after my first dose) and on 3/19/2021. The d... Read more
I was very dizzy when I woke up on 3/18/2021 (one week after my first dose) and on 3/19/2021. The dizziness lasted for about 20 minutes. I have also been feeling generally fatigued. On 3/29/2021 I felt so fatigued that I took a sick day off from work. For all three events, I felt normal by mid-morning.
62 2021-04-07 loss of personal independence in daily activities, impaired work ability Fever (1.5 to 3.5 degrees fever) for at least 24 hours following the 2nd dose of vaccine, muscular b... Read more
Fever (1.5 to 3.5 degrees fever) for at least 24 hours following the 2nd dose of vaccine, muscular body aches, joints aching, headache, inability to work or conduct normal activities
62 2021-04-07 sleep disorder Fever, muscle aches, muscle cramps, muscle fassiculations, lethargy, fever, chills, nausea, joint pa... Read more
Fever, muscle aches, muscle cramps, muscle fassiculations, lethargy, fever, chills, nausea, joint pain, weakness, rash, head/ nasal congestion. Started around 7:00pm day of the vaccine( given at 8:00am). Unable to sleep at all that night due to concerns over breathing and due to maladies and general body pain. Rash erupted ~4:00am.
62 2021-04-09 disturbance in attention, impaired work ability Moderna COVID-19 Vaccine EUA Headache, fatigue, chills, fever, body aches, hard to focus and functi... Read more
Moderna COVID-19 Vaccine EUA Headache, fatigue, chills, fever, body aches, hard to focus and function. Missed one day of work. Most symptoms other than a slight headache were gone in 24 hours.
62 2021-04-09 feeling abnormal, anxiety injection site extremely sore and could not lift arm - this lasted several days .. i can still feel ... Read more
injection site extremely sore and could not lift arm - this lasted several days .. i can still feel where injection was given to this day. Had headache on and off for days Experienced hives - in various areas .. not heavily but still had some Felt sickish and weird and very anxious. Not sure about taking second dose as it is scaring me. Had an injection in other arm for pain about 45 years ago and still hurts till this day
62 2021-04-09 feeling abnormal 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 2021-04-09 feeling abnormal dizziness/vertigo, feeling unstable; have fallen twice in past two weeks, 2nd time resulted in broke... Read more
dizziness/vertigo, feeling unstable; have fallen twice in past two weeks, 2nd time resulted in broken hand requiring surgery
62 2021-04-09 impaired work ability My arm had a red dot at the point of injection, my arm has turned red at the site of injection, abou... Read more
My arm had a red dot at the point of injection, my arm has turned red at the site of injection, about the size of your hand and is hard to the touch, still sore, not like the 2nd day but still sore. My husband got his vaccine right before me and did not have the red dot at the point of injection. I had to take off work the 2nd day because I did not feel well.
62 2021-04-09 sleep disorder Arm pain still after 2 days. The evening of the 8th and early morning of the 9th. Both legs hurt all... Read more
Arm pain still after 2 days. The evening of the 8th and early morning of the 9th. Both legs hurt all night long. I spent more time awake than sleeping. The day and early evening of the 9th leg pain in right leg back of thigh.
62 2021-04-10 feeling abnormal Arm at injection site at approximately 12:00. General feeling of malaise came over me around 3:00pm ... Read more
Arm at injection site at approximately 12:00. General feeling of malaise came over me around 3:00pm and continues today (April 11). Body aches, headache, fatigue, low-grade fever during the night and continues today. "Brain fog" Joint pain. Took ibuprofen for pain on April 10 at 12pm, 7pm. Took ibuprofen on April 11 at 3:30am, 6:30 am. This session timed out after 20 minutes because I dozed off.
62 2021-04-10 memory impairment, disorientation, feeling abnormal As I was driving away from vac site, I became increasingly disoriented and could not navigate a very... Read more
As I was driving away from vac site, I became increasingly disoriented and could not navigate a very easy route home which should take about 40minutes. Suddenly unable to read freeway signs or judge distances, or speed on the freeway. Light began to hurt my eyes, headache pounded & became extremely nauseous and tired. Got off fwy, because I didn't feel safe, planned to take surface streets, but became so disoriented (on a route I know well) it took about 1 1/2 hours to get to a familiar location that should have taken 20 mins. K ept making wrong turns even when using maps. Finally, had to call my husband to pick me up. Couldn't make it home & I use this route often and have been for over 20 years. Once home, extremely tired for about 3 days. As the weeks went by my disorientation did not completely go back to normal. I still am impaired (compared to my normal functioning). Unable to juggle a few items in my head as I normally do. My brain feels foggy & I am having memory issues with things that are routine. When I went to have my hair colored on 2/26/21 my hair looked the same as always afterward, but when I returned 4/1/21, I had lost about 1/3 of my hair -- it began falling out each time I brushed it or washed. It seems to have stopped falling out for now.
62 2021-04-11 insomnia, panic attack Day 8 post vaccine (4/1/2021), my left arm became sore again, had a rash, and was swollen. Along wit... Read more
Day 8 post vaccine (4/1/2021), my left arm became sore again, had a rash, and was swollen. Along with the arm issues, I got diarrhea, burning throughout my body, neuralgia, headache, stiff joints, and aching muscles. April 7th, I started to get psychiatric symptom of mania. I HAVE NO HISTORY OF BI-POLAR ILLNESS, TAKE NO PSYCH MEDS, AND AM TYPICALLY EVEN-TEMPERED!!!!!My husband noticed pressure of speech, my not sleeping and eating, and I feel like a whoosh of energy courses from my feet to my head continually now. At times I feel panic, although I have nothing externally in my life that would cause such symptoms. I had to call al shrink at midnight on 4/10/21 to get an Rx for Ativan. I AM LIVID IN MY NEW MANIC STATE!!!! I hate taking drugs because another drug messed me up!
62 2021-04-12 sleep disorder I received the 2nd dose of Moderna on 4/7/21 @ 3:51 pm. I became extremely sick by 2:00 am 4/8/21. N... Read more
I received the 2nd dose of Moderna on 4/7/21 @ 3:51 pm. I became extremely sick by 2:00 am 4/8/21. Nausea, chills, body/muscle pain, headache, fever of 103.9 and stomache issues. Extremely tired but was too uncomfortable to sleep for several days. By 4th day was doing much better. Today is day6th day after shot and still not feeling 100%. I stayed hydrated and took tylenol.
62 2021-04-13 disturbance in attention, impaired work ability About 4 hours after shot, body aches and arm soreness began. About 1:00 a.m. that night (about 12 h... Read more
About 4 hours after shot, body aches and arm soreness began. About 1:00 a.m. that night (about 12 hours later) woke up with terrible body aches all over, headache, very hard chills and high fever all night. Mostly 102 to 103 but at 3:00 a.m. it reached 104 for 15-30 minutes. Husband was getting ready to take me to emergency room but fever then dropped to 103 so we monitored and did not go to ER. Could not focus or think clearly. Fever dropped to 101 by morning, took acetametaphin. Fever ranged from 99 to 101 Monday and Tuesday till it broke Tuesday afternoon. Missed 2 days of work. Still tired, some body aches but returned to work Wednesday.
62 2021-04-14 anxiety My body just felt bad and did not feel well for 10 days, and anxiety was incipient , with the second... Read more
My body just felt bad and did not feel well for 10 days, and anxiety was incipient , with the second shot four days later it felt like an anxiety attack on steroids, and left me with annoying tinnitus in left ear. Tinnitus and anxiety continues , and not feeling well, painful rash on arm that received the shot on second dose, which cleared up, and painful headache for 24 hrs, various aches and pains
62 2021-04-14 disorientation, impaired work ability, feeling abnormal, confusional state 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 feeling abnormal Severe pain in kidneys, hamstring pain, dizziness, pain in sinus area. Weird feeling in head.
62 2021-04-14 irritability, feeling abnormal Slight chills then feel hot-no fever 2 days so far, nausea , brain fog, slight sore throat, slight ... Read more
Slight chills then feel hot-no fever 2 days so far, nausea , brain fog, slight sore throat, slight runny nose, irritable.
62 2021-04-14 sleep disorder Right sided tingling, right sided weakness, flashes of light of the left eye, interrupted sleep, rig... Read more
Right sided tingling, right sided weakness, flashes of light of the left eye, interrupted sleep, right pinky turned purple.
62 2021-04-16 anxiety Was given in outside clinic, pt sent to ED, do not have other details at this time. Pt states appro... Read more
Was given in outside clinic, pt sent to ED, do not have other details at this time. Pt states approximately 10 min after receiving vaccine, she started to have throat tightening and started to become very anxious. Clinic gave patient one dose of epipen and benadryl 50mg IM and sent pt to ED. Upon ED arrival, throat is improved, pt still very anxious. Throat feels dry. Exam unremarkable
62 2021-04-16 feeling abnormal Fever, body aches, fatigue, nausea, brain fog
62 2021-04-17 feeling abnormal, confusional state 2/17/2021 4:20pm Tongue thickened 2/17/2021 5:50pm Both nostrils burning 2/17/2021 6:09pm Called Mod... Read more
2/17/2021 4:20pm Tongue thickened 2/17/2021 5:50pm Both nostrils burning 2/17/2021 6:09pm Called Moderna and left voice message 2/17/2021 6:50pm Entire body felt horrible and went to bed 2/18/2021 6:30am Woke with sore throat 2/18/2021 9:01am Received call back from Moderna, stated that I was having an allergic reation, advised against 2nd vaccine and was directed to my Physician or ER 2/18/2021 10:00am Constriction in throat and upper respiratory area, confusion 2/18/2021 1:39pm Went to ER. Dr. confirmed allergic reaction, advised against 2nd vaccination, prescribed Cetirizine 10mg and Diphenhydramine 25mg
62 2021-04-18 anxiety, confusional state, suicidal thoughts Unable to discern drugs by their name at job, anxiety, cognitive disruptions, suicidal ideation
62 2021-04-18 anxiety 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 2021-04-18 delirium, disturbance in attention delerious; Fever; Rash; horrible body aches; Skin on fire; severe headache; pounding a rod into brai... Read more
delerious; Fever; Rash; horrible body aches; Skin on fire; severe headache; pounding a rod into brain; dizzy; lack of concentration; eyes not dilating; ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (delerious) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 001B21A) 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) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DELIRIUM (delerious) (seriousness criterion medically significant), PYREXIA (Fever), VACCINATION SITE RASH (Rash), PAIN (horrible body aches), SKIN BURNING SENSATION (Skin on fire), HEADACHE (severe headache), HEADACHE (pounding a rod into brain), DIZZINESS (dizzy), DISTURBANCE IN ATTENTION (lack of concentration), MIOSIS (eyes not dilating) and TINNITUS (ringing in ears). At the time of the report, DELIRIUM (delerious), PYREXIA (Fever), VACCINATION SITE RASH (Rash), PAIN (horrible body aches), SKIN BURNING SENSATION (Skin on fire), HEADACHE (severe headache), HEADACHE (pounding a rod into brain), DIZZINESS (dizzy), DISTURBANCE IN ATTENTION (lack of concentration) and MIOSIS (eyes not dilating) outcome was unknown and TINNITUS (ringing in ears) had not resolved. This case concerns a 62-year-old female with a serious unexpected event of delirium, and nonserious unexpected dizziness, pain, skin burning sensation, disturbance in attention, miosis, tinnitus, and expected fever, headache, vaccination site rash. Event onset 2 days after second dose mRNA-1273. Event outcomes ongoing or 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 62-year-old female with a serious unexpected event of delirium, and nonserious unexpected dizziness, pain, skin burning sensation, disturbance in attention, miosis, tinnitus, and expected fever, headache, vaccination site rash. Event onset 2 days after second dose mRNA-1273. Event outcomes ongoing or 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.
62 2021-04-18 feeling abnormal, excessive sleepiness Headache, severe fatigue, body aches, nausea, feverish feeling but no fever., brain fog.. Slept for... Read more
Headache, severe fatigue, body aches, nausea, feverish feeling but no fever., brain fog.. Slept for 3 days initially, then very weak with headache continuing for 5 more days. Felt well for 3 days then all symptoms re-appeared . It is now 8 days I have been feeling extremely fatigued, headache, nausea, faint, aches, feverish without a fever.,, brain fog. Not getting better or worse.
62 2021-04-18 feeling abnormal Worsening severe headaches, weakness; tiredness, feeling like will stroke out.
62 2021-04-18 excessive sleepiness Second dose received 8:55am, symptoms began that evening around 10 pm lasting 3 days. Fever, chills,... Read more
Second dose received 8:55am, symptoms began that evening around 10 pm lasting 3 days. Fever, chills, body aches, nausea, headache, sore arm . Day after slept all day long which is very unusual for me. Felt like I'd been run over by a truck...
62 2021-04-18 excessive sleepiness 10PM-4/15/2021-Dizziness began. Room was spinning could not stand. Stomach began to hurt bad. Achy a... Read more
10PM-4/15/2021-Dizziness began. Room was spinning could not stand. Stomach began to hurt bad. Achy and 100.4 Fever/sweats. Dry Heaves began 4/16/2021 @ 1:30AM, Dry Heaves again at 3:30AM, and at 7:15AM-4/16/2021. Also, Chills, Very tired, sore arm but tolerable. Slept 1-1/2 days. Still not well on 4/17 and 4/18. Could not eat at all on 4/16/2021. By 4/19, finally feeling more normal, but still lightheaded. Not back to 100%. Somewhat weak.
62 2021-04-18 sleep disorder Got the vaccine had shooting pain down the arm, about 10 days after she got ringing in her ears, whi... Read more
Got the vaccine had shooting pain down the arm, about 10 days after she got ringing in her ears, which started pretty loud. Then she got ear stuffiness, which comes and goes and comes when she's laying down at night and eases up during the day somewhat. She then had pulsating tinnitus, both at the same time. It's very scary, did it do permanent damage and doesn't allow her to sleep. She went to an ENT last week on 4/15/21 and was informed that a few people had come in with the same. He looked in her ears and had no wax in it. Her hearing was impeccable for her age, and did not see anything abnormal. Is going to send her for a carotid artery test in the middle of May. There was not much that he could do for it. She has an audiologist who is a friend and told her that it might subside over time if it was viral tinnitus. The ringing is going down but the stuffiness feeling is still there. She is going to get the 2nd vaccine, but scared that this is going to flare up again.
62 2021-04-20 feeling abnormal, memory impairment 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 2021-04-21 excessive sleepiness Excessive thirst with both courses for four days, and no, I am not a diabetic, and no, I was not deh... Read more
Excessive thirst with both courses for four days, and no, I am not a diabetic, and no, I was not dehydrated prior. 2nd course, 2nd day, chills to the bone, slept EIGHTEEN HOURS.
62 2021-04-22 anxiety Within 5 minutes, I started to feel tingly all over my body, weak then shakey, light headed then an... Read more
Within 5 minutes, I started to feel tingly all over my body, weak then shakey, light headed then anxiety started to appear, couldn't take a deep breath, little dizzy. I was able to walk, so I asked to see a Nurse. I was taken to an area where I was given oxygen and rest. My blood sugar was taken, per my request, it was (BG 160) I had eaten breakfast that morning. I rested with oxygen for about 30 minutes, I felt an improvement, so Nurse asked to stand/walk slow...I did and got just a little dizzy, so I sat with oxygen for about another 20-25 minutes and decided to go home. Nurse checked my oxygen level, she said it was 100% and my heart rate/pulse was 78. I decided with the agreement of the Nurse, that I was was okay to go home and rest. Upon arriving at home, I drank some water and rested. My arm didn't hurt at all, until a few hours later and then for 1 day. I took a nap, when I awoke a had a slight headache, but was feeling much better, not dizzy, light headed and weakness was minimal, as well as shakiness was minimal. Also, a little taste at back of throat/sinus area, like a post nasal drip, kind of like when I go to the dentist. I never did take Benadryl. That strange sensation went away within the day.
62 2021-04-22 feeling abnormal Feel tingling feeling on left nose; Continued pain at site of injection; arm numb; ears numb; Bell's... Read more
Feel tingling feeling on left nose; Continued pain at site of injection; arm numb; ears numb; Bell's Palsy; Left arm (injection arm) went numb; "Charley" horse like pain in left neck; Charley" horse like pain in left face; Tingling feeling on left ear; Tingling feeling on left face; Felt exhausted; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hormone replacement therapy. Concurrent medical conditions included Asthma. 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 HYPOAESTHESIA (Left arm (injection arm) went numb), NECK PAIN ("Charley" horse like pain in left neck), FACIAL PAIN (Charley" horse like pain in left face), PARAESTHESIA EAR (Tingling feeling on left ear), PARAESTHESIA (Tingling feeling on left face), FEELING ABNORMAL (Felt exhausted), HYPOAESTHESIA (arm numb) and PARAESTHESIA EAR (ears numb). On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Continued pain at site of injection). On 14-Mar-2021, the patient experienced PARAESTHESIA MUCOSAL (Feel tingling feeling on left nose). On an unknown date, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell's Palsy), HYPOAESTHESIA (Left arm (injection arm) went numb), NECK PAIN ("Charley" horse like pain in left neck), PARAESTHESIA EAR (Tingling feeling on left ear), PARAESTHESIA (Tingling feeling on left face), FEELING ABNORMAL (Felt exhausted), PARAESTHESIA MUCOSAL (Feel tingling feeling on left nose), HYPOAESTHESIA (arm numb), PARAESTHESIA EAR (ears numb) and VACCINATION SITE PAIN (Continued pain at site of injection) outcome was unknown and FACIAL PAIN (Charley" horse like pain in left face) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Treatment included Tylenol, Benadryl and Prednisone. Based on the current 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-Apr-2021: Event Bell's Palsy was diagnosed.; 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 2021-04-23 excessive sleepiness Husband reports that pt was taken to local hospital by EMS & transferred to facility following a sei... Read more
Husband reports that pt was taken to local hospital by EMS & transferred to facility following a seizure at home around 22:00. She has had seizure type activity prior to this event she was admitted to medical center and treated (he didn't go into detail). She was released and is home she is still having issues with severe weakness and fatigue and sleeping most of the time. The events were reported to our hospital on 4/14/21.
62 2021-04-23 excessive sleepiness 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 feeling abnormal Covid arm rash appeared suddenly on both elbows and also across face in mask pattern. Also noted th... Read more
Covid arm rash appeared suddenly on both elbows and also across face in mask pattern. Also noted the day before that my left eye turned red and then cleared out too....not broken blood vessel. After rash became itchy in various spots and also developed brain fog and mild headache and exaustion, but was fine and active during the day prior to this, also yawning a lot.
62 2021-04-24 insomnia First reaction was Moderna Arm ... & then Tinnitis (constant ringing in left ear). Difficulty sleep... Read more
First reaction was Moderna Arm ... & then Tinnitis (constant ringing in left ear). Difficulty sleeping w/ ringing 24/7. Ringing is worse when laying down. Continuous ringing in both ears after the 2nd dose.
62 2021-04-25 anxiety SHE FELT ANXIOUS AFTER RECEIVING THIS DOSE. ON SITE EMS RESPONDED. HER VITALS ARE BELOW. IN TYPING T... Read more
SHE FELT ANXIOUS AFTER RECEIVING THIS DOSE. ON SITE EMS RESPONDED. HER VITALS ARE BELOW. IN TYPING THIS UP FROM AN EMS REPORT, I FOUND IN THE DATABASE, THAT SHE HAD HAD 2 PREVIOUS DOSES BEFORE THIS DOSE ON 3/26/21. THE 1ST DOSE ON 2/26/21 HERE AT THIS FACILITY. THE 2ND IN ANOTHER TOWN CALLED ON 3/20/21 AND THEN BACK AT OUR FACILITY ON 3/26/20 WHERE SHE GOT ANXIOUS AT. I HAVE REACHED OUT TO HER AND LEFT HER A MSG TO PLEASE CALL ME BACK ON 4/22 AND 4/23. AS OF 4/26 NO CALL BACK. NOTE: I WAS WONDERING IF THE VACCINE ON 3/20 IN MIGHT NOT BE HER, THAT IT WOULD BE ENTERED ACCIDENTLY UNDER HER FILE.
62 2021-04-25 feeling abnormal Sore right arm. red right arm. This was followed by pain to the right scapula, fatigue, and "brain... Read more
Sore right arm. red right arm. This was followed by pain to the right scapula, fatigue, and "brain fog". This finally has improved as of today 4/26/21
62 2021-04-25 feeling abnormal Fever 101.4 x6 hours Headache Light headed and unsteady Fatigue All over muscle soreness and fatigue... Read more
Fever 101.4 x6 hours Headache Light headed and unsteady Fatigue All over muscle soreness and fatigue Bone pain at elbows Achy eyes Brain fog
62 2021-04-26 feeling abnormal Beginning approximately Day16 after vaccine dose, noted "woozy"/sort of lightheaded & "off"/off bala... Read more
Beginning approximately Day16 after vaccine dose, noted "woozy"/sort of lightheaded & "off"/off balance sensation I have never experienced before...solid frontal headache for first few days but that is now gone, but "off" sensation persistently continues (now @ Day32). Went to Walgreens 4/26 for Covid test, to rule out mild covid case (awaiting results).
62 2021-04-26 impaired work ability Per Patient: extreme dizziness at work. Unable to finish work. Driven home by husband. Starting 3/... Read more
Per Patient: extreme dizziness at work. Unable to finish work. Driven home by husband. Starting 3/9/21 and lasting 14 days.
62 2021-04-26 insomnia, irritability, agitation Irritability; Impatience; Agitation; Inability to eat; Inability to sleep; Aggression; Mania; Genera... Read more
Irritability; Impatience; Agitation; Inability to eat; Inability to sleep; Aggression; Mania; General burning sensation over the whole body; Rash on Arm; Headache; Swelling over the area; Rash over the area; Sore joints; Sore muscles; Neuropathy; Systemic Inflammation; Diarrhea; Hasn't Felt Well; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 62-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. Concomitant products included ESTRADIOL from 01-Mar-2020 to an unknown date for HRT. On 23-Mar-2021 at 9:30 AM, 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 (Sore Arm). On 01-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), INFLAMMATION (Systemic Inflammation), DIARRHOEA (Diarrhea), VACCINATION COMPLICATION (Hasn't Felt Well), BURNING SENSATION (General burning sensation over the whole body), RASH (Rash on Arm), HEADACHE (Headache), VACCINATION SITE SWELLING (Swelling over the area), VACCINATION SITE RASH (Rash over the area), ARTHRALGIA (Sore joints) and MYALGIA (Sore muscles). On 05-Apr-2021, the patient experienced IRRITABILITY (Irritability), IMPATIENCE (Impatience), AGITATION (Agitation), EATING DISORDER (Inability to eat), INSOMNIA (Inability to sleep), AGGRESSION (Aggression) and MANIA (Mania). On 09-Apr-2021, VACCINATION SITE PAIN (Sore Arm) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), INFLAMMATION (Systemic Inflammation), DIARRHOEA (Diarrhea), VACCINATION COMPLICATION (Hasn't Felt Well), IRRITABILITY (Irritability), IMPATIENCE (Impatience), AGITATION (Agitation), EATING DISORDER (Inability to eat), INSOMNIA (Inability to sleep), AGGRESSION (Aggression), MANIA (Mania), BURNING SENSATION (General burning sensation over the whole body), RASH (Rash on Arm), HEADACHE (Headache), VACCINATION SITE SWELLING (Swelling over the area), VACCINATION SITE RASH (Rash over the area), ARTHRALGIA (Sore joints) and MYALGIA (Sore muscles) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details not provided. The patient was able to sleep with the lorazepam and was able to discontinue it on 13 Apr 2021 and never needed gabapentin. Mania and agitation increased as the day progressed. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. On 15 Apr 2021, The patient mood felt better and upbeat again. Still had burning limbs and diarrhea. 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 12-Apr-2021: Follow up contains other events and incorporated in the narrative. On 19-Apr-2021: Concomitant medication added, seriousness of the event neuropathy and clinical course of narrative was 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.
62 2021-04-26 nervousness, feeling abnormal After about ten minutes, patient indicated she wasn't feeling right. She described "a funny feeling... Read more
After about ten minutes, patient indicated she wasn't feeling right. She described "a funny feeling around (her) eyes." There was no apparent swelling or dizziness and no other signs of reaction. I took her blood pressure and it was 198/101 mmHg. She thought maybe it shot up because she was nervous, but that she has a history of high blood pressure. After about 5 minutes we rechecked it and it came down to 168/98. We waited 5 more minutes and rechecked again. It was 175/92. Her pulse was between 72-77 each time. She waited for a total of a half hour and had no other symptoms. She had a doctors appointment tomorrow and said she would address it with them at that time.
62 2021-04-27 impaired work ability Vaccine at 1:30pm on 4/26/21. At 8:30pm my left arm was sore, I couldn't lift it up. I worked that ... Read more
Vaccine at 1:30pm on 4/26/21. At 8:30pm my left arm was sore, I couldn't lift it up. I worked that night 4/26/21 at 9:00 pm. At 3:00am on 4/27/21 i was very fatigue. By the time i got home from work at 5:30am which was only 1.9 miles away I had a massive headache, fever 101.9, chills, body aches, joint pain. I could not go to work that night, I called in sick on 4/27/21. At 7:30am on 4/28/21 mild diarrhea and left arm is still sore
62 2021-04-27 nervousness Pt reports feeling a "little shakey" with itching to face/top of head/back of neck and dry mouth. Se... Read more
Pt reports feeling a "little shakey" with itching to face/top of head/back of neck and dry mouth. Self administered chlortrimeton, an allergy medication that she usually takes Qday for cat allergies. Within 15 minutes she reported itchy feeling had resolved.
62 2021-04-27 sensation of foreign body SWEATS, FELT LIKE THERE WAS A LUMP IN THROAT AND HAD DIFFICULTY SWALLOWING. NO AIRWAY OBSTRUCTION.
62 2021-04-30 amnesia 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 feeling abnormal The only thing that I would like to report is that my reaction was delayed compared to the other rep... Read more
The only thing that I would like to report is that my reaction was delayed compared to the other reports I have heard. I received my second vaccination on Friday and did fine for the entire weekend. I was slightly tired and took Tylenol to prevent any problems. By Monday morning (3rd day after), I felt terrible. I had the usual low grade temperature, extremely tired and I felt like I had a chest cold. I started feeling better by Friday morning (after 4 days). So my report is that I had the known symptoms but it was delayed with me and lasted a bit longer with me than others have reported.
62 2021-05-03 feeling abnormal Injection site presented as a Lyme Bullseye the size of a half dollar on day 3. Then outer red ring ... Read more
Injection site presented as a Lyme Bullseye the size of a half dollar on day 3. Then outer red ring blistered with some breaking and scabbing over. Coloring faded over time and blisters went away after a week or two. But as of today the site painful to touch like a bruise and I can still feel weird skin in the circular area. Did nothing but monitor but wonder how many others with Chronic Lyme (which the CDC still says doesn?t exist) had this weird reaction.
62 2021-05-04 feeling abnormal, insomnia 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 impaired work ability Received my shot at 8:30 came home 8 breakfast went to bed cause I work night shift woke up at 1 o'c... Read more
Received my shot at 8:30 came home 8 breakfast went to bed cause I work night shift woke up at 1 o'clock p.m. could not even lay on my arm cause it hurts a bag could not raise it above my shoulder and my face was tingling my legs have bumped all over it I ached real bad and was running a fever of 99.8 I got up and took 2 tyneol and also a benadyrll. DID MISS A WHOLE NIGHT OF WORK ,WHICH WAS 11 HRS AT 19.75 AN HR
62 2021-05-04 sleep disorder 3 days after the injection, I was fatigued, and my joints in my arms and legs were sore. My arms fe... Read more
3 days after the injection, I was fatigued, and my joints in my arms and legs were sore. My arms felt so heavy I felt it was an effort to lift them. This was identical to the way I felt after my first vaccine on 3/11/21. However, I developed an additional symptom of pain in my right knee. It became swollen, warm, and there was pain on the backside of the knee as well as the kneecap area. This became so severe that I could not put any weight on this knee on Sunday afternoon ( 3 full days after shot). I know I didn't injure the knee because on Saturday we drove and I was just in the car for 2 days. It hurt to extend the knee but felt better to elevate it. A knee brace was not helpful. IThe pain woke me up almost every night for the last 3 weeks. Ibuprofen barely helps. For a couple of days last week, the knee would crack with every step. This was painful, so I limited walking. I have been staying off of this leg ever since and am waiting for an appointment with an orthopedist on the 20th. It is just starting to feel better. It is still warm but yesterday I finally saw the kneecap peek out. I am not certain this is from the vaccine and i can only find one journal article describing a "flare up" of rheumatoid arthritis following the shot. I do not have arthritis (yet) so the article was not helpful. I have had bursitis in my hip twice but not for over 10 years. I am getting an Xray tomorrow.
62 2021-05-05 feeling abnormal Intermittent Temperature Lightheaded/brain fog Extreme extreme fatigue/exhaustion Queasy Shortnes... Read more
Intermittent Temperature Lightheaded/brain fog Extreme extreme fatigue/exhaustion Queasy Shortness of breath- intermittent Joint pain Dry mouth Since 3/26/21 There is no treatment
62 2021-05-07 feeling abnormal EXTREME BRAIN FOG AND TINNITUS. Headfulness, inner ear pressure, hot inside at times, 8 out of 10 ... Read more
EXTREME BRAIN FOG AND TINNITUS. Headfulness, inner ear pressure, hot inside at times, 8 out of 10 loud tinnitus for the first month after the shot. NEUROLOGICAL buzzing up and down spine, ankles. MUSCLE TWITCHING 20 mins at a time, side, legs, upper arm. 8 weeks out, still have tinnitus level 3 to 6 ... 24 hours a day. slight buzzing in my brain, MEMORY issues. ENT- offered prednisone steroid. Did not relieve long term tinnitus. Neurologist- nothing, didn't believe it was related. Didn't know what to do Internist - Xanax. Didn't know what to do Immunologist` Still waiting on extensive bloodwork that takes 3 weeks to turnaround results unknown Low histamine diet seems to help but is hard to maintain.
62 2021-05-08 loss of personal independence in daily activities, sleep disorder Itching in the neck that does not go away with anything, I can not sleep at all due to the itching, ... Read more
Itching in the neck that does not go away with anything, I can not sleep at all due to the itching, I can not do anything this is desperate to the degree that I do not want to live like this anymore, please who can help me soon, what do I do I wait for an answer prompt, thank you.
62 2021-05-10 disorientation 2 minutes after vaccination, patient complained of dizziness and arm pain and was lowered to the gro... Read more
2 minutes after vaccination, patient complained of dizziness and arm pain and was lowered to the ground. Patient became extremely disoriented. Initial vitals: BP 200/98, HR 110, Respirations 20, o2sat 99%. Patient started profusely vomiting. EMS was called. Patient was reoriented (AAOX4) however was still very dizzy. After EMS arrived, patient continued to experience dizziness and vomited. Patient was transported to hospital for further testing and observation.
62 2021-05-10 insomnia, feeling abnormal My feet were swollen last week; Headache; Bell's palsy; Could not open an eye on left side; Can't ta... Read more
My feet were swollen last week; Headache; Bell's palsy; Could not open an eye on left side; Can't talk great; Can't blink; Mouth was crooked.; Feeling something wrong; Mouth still numb and twisted; Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) 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 01-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 FACIAL PARALYSIS (Bell's palsy) (seriousness criterion medically significant), EYE MOVEMENT DISORDER (Could not open an eye on left side), SPEECH DISORDER (Can't talk great), EYE DISORDER (Can't blink), DYSKINESIA (Mouth was crooked.), FEELING ABNORMAL (Feeling something wrong), HYPOAESTHESIA ORAL (Mouth still numb and twisted) and INSOMNIA (Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping). On an unknown date, the patient experienced PERIPHERAL SWELLING (My feet were swollen last week) and HEADACHE (Headache). At the time of the report, FACIAL PARALYSIS (Bell's palsy), EYE MOVEMENT DISORDER (Could not open an eye on left side), SPEECH DISORDER (Can't talk great), EYE DISORDER (Can't blink), DYSKINESIA (Mouth was crooked.), FEELING ABNORMAL (Feeling something wrong), HYPOAESTHESIA ORAL (Mouth still numb and twisted), INSOMNIA (Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping), PERIPHERAL SWELLING (My feet were swollen last week) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Lab details were not provided. Treatment medication for the symptoms included. prednisone 20 mg for 7 days valacyclovir 500 mg for 7 days white petrolatum to lubricate under the patch muscle relaxant for sleep - described as effective 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 2021-05-16 panic attack 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 anxiety Patient presented to the ED on 3/14/21 with anxiety. Patient presented to the ED and was subsequentl... Read more
Patient presented to the ED on 3/14/21 with anxiety. Patient presented to the ED and was subsequently admitted on 4/6/21.
62 2021-05-17 feeling abnormal Within 24 hours started feeling tired, headache, chills. Within 72 hours had same symptoms but feel... Read more
Within 24 hours started feeling tired, headache, chills. Within 72 hours had same symptoms but feeling worse. Only relief was aspirin taken every 3 hours. The morning of day 5 I woke up early so I could go have blood work done. Felt overly tired and a little light headed on the drive almost like I jumped up to fast and was just not awake. Lab took my blood pressure, it was 109/72. By the time I got home i was extremely light headed and dizzy. I took BP at home, 110/74. Felt extremely bad, very dizzy. Almost like I was going to faint. I finally drank some tomato juice ate Greek olives, other salty snacks to try to get my BP to come up. By the time I went to bed my BP went up to 135/81 had headache & dizzy. Day 6 (today) Still have headache & dizziness. BP was 131/80 when I woke.
62 2021-05-17 insomnia 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 depression, feeling abnormal, anxiety 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 impaired work ability 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 2021-05-18 insomnia 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 2021-05-19 impaired work ability Patient returned to clinic at 4:20pm - 2hr after receiving vaccine - reporting of difficulty breathi... Read more
Patient returned to clinic at 4:20pm - 2hr after receiving vaccine - reporting of difficulty breathing and dizziness (both 7/10). Patient reports unable to work. HR=74, RR=16, SP02=98% on room air. Received liquid benadryl 30mL/75mg PO. Symptoms improved following administration and was able to speak without gasping per clinic staff. Patient was released to home and transported there via the company vehicle following resolution of symptoms at 4:40pm.
62 2021-05-19 sleep disorder Fatigue, very High temp from 99-104 for two days, intense migraine(no light), very dizzy- could not... Read more
Fatigue, very High temp from 99-104 for two days, intense migraine(no light), very dizzy- could not function, nauseated,-can?t eat, rash & flushed face & felt as if I was allergic with itching all over, could not rest, could not sleep due to migraine pain, face very itchy, neck stiffness hard to lift my arms parallel with my body! I had to take Benadryl which didn?t really affect my allergic reaction until the 3rd day I noticed it begin helping with the allergy symptoms! I had Covid twice & these side affects were as bad as my worst day in Covid! I am now scared to take the second shot!
62 2021-05-20 sleep disorder Individual received her second moderna vaccine at 9:30 on 4/29/21- 12 hours later she went to bed an... Read more
Individual received her second moderna vaccine at 9:30 on 4/29/21- 12 hours later she went to bed and had right hip, groin and lower back pain that was described as extreme and she was unable to sleep. She did not take any medication at this time because she was afraid to due to the vaccine. On 5/1/21 she went to healthcare facility because she was having severe pain in her abdominal right lower quadrant, and stated she was worried she had appendicitis. 5/1/21 CT, blood work and urinalysis- client indicated the CT was clear, blood work was good, urinalysis showed some bacteria and she was started on antibiotics. 5/9/21 Went to healthcare facility due to not being able to walk, pins and needles sensation with stabbing hot pain in her groin and back. Her urine screen was clear, xrays were taken but looked okay considering her age. Stated She was started on prednisone, muscle relaxers and anti inflammatory medications. Stated she had never taken the meds they prescribed but they did not help. She went back to her PCP on 5/13 - was referred for Physical therapy. Individual stated she has gone to two therapy appointments and pain is lessening but is elicited with standing. pain continues to be localized in groin and upper leg.
62 2021-05-23 insomnia Date of shot-May 20, 2021 (Thurs) injection site right arm slightly sore. Had chemical taste in mout... Read more
Date of shot-May 20, 2021 (Thurs) injection site right arm slightly sore. Had chemical taste in mouth within 30 minutes after shot; urine had chemical odor after shot. May 21, 2021 (Fri) injection site right arm more sore and could not turn my head to the right as my right neck (lymph nodes) were all swollen. Had chills, headache, fatigued and threw up after eating light breakfast. I iced and took Advil. PM/Bedtime-could not get deep breaths through nose breathing/had to mouth breath-hardly slept. May 22, 2021 (Sat) called emergency room and Pharmacist (primary Pharmacist still on vacation) was told to switch to HEAT pad on my neck, take Advil. Right arm injection site, up the arm, across collar bone, up the right neck to ear lobe all swollen and painful since Friday-hardly any change. May 23, 2021 (Sun) so tired from not sleeping well (could not lay on right side since the shot) and slept mostly all day. May 24, 2021 (Mon) feel a little better but neck is still swollen and sore. 50% motion back to turn my head to the right. Breathing better when laying down through my nose as well. I would like to talk with a Doctor at the CDC as I do not have a Primary Doctor, and was just referred to one, but cannot schedule to see him until mid June. I am nervous if the 1st Moderna shot is causing internal swelling, bleeding, etc. ? And I am not planning on getting a 2nd Moderna shot after this severe reaction caused by the 1st shot. I am healthy, never take drugs, get flu shots, etc. and my body felt like it was fighting a battle...and I am not 100% myself. I want to know WHEN my neck will heal, WHEN my motion will be back to 100% as it is making driving challenging, and what next steps you recommend. Please advise.
62 2021-05-24 loss of personal independence in daily activities At the vaccination site, the vaccinator did not open the car door to administer the vaccine - someon... Read more
At the vaccination site, the vaccinator did not open the car door to administer the vaccine - someone was instructing him and pointed out the acromion and stepped away. The patient reports that he did not mention it should be 3 finger widths below. The patient reports receiving the vaccine into the bony part, she said it felt like childbirth pain. The next morning she reports not being able to raise her arm. The patient reports that she has received steroids, PT, and acupuncture and is now looking at surgery since she still cannot play tennis or exercise like she used to.
62 2021-05-25 feeling abnormal 4/13- GOT COVID VACCINE 4/20- HAD COVID TEST FOR UPCOMING PROCEDURE, IT WAS NEGATIVE 4/22- HAD OUT P... Read more
4/13- GOT COVID VACCINE 4/20- HAD COVID TEST FOR UPCOMING PROCEDURE, IT WAS NEGATIVE 4/22- HAD OUT PATIENT INNER EAR PROCEDURE 4/24- DID NOT FEEL GOOD 4/24-5/1- RAN A HIGH FEVER 4/29- WENT TO PCP AND HAD A COVID TEST, IT WAS POSITIVE 5/1- WENT TO ER AND WAS HOSPITALIZED ( WAS ON OXYGEN, 6-7 CONTINOUS) 5/7- CAME HOME WITH NO OXYGEN
62 2021-05-25 insomnia, memory impairment, feeling abnormal, disturbance in attention She got her vaccine, it was more painful, she had fever, she spent 2 days just sleeping due to being... Read more
She got her vaccine, it was more painful, she had fever, she spent 2 days just sleeping due to being tired. She felt as if she was "out of it". She was not focused to work on the computer, to do school work and decided to not do that. She is a multitasker and was hard for her to get on her treadmill as she was off balanced and could not do that. She just had a brain fog, memory problems, was off doing her homework and reading things, but the clarity and focus was not there. She knew the answers to her tests, but when she was writing down it was not being written down as the answers in her head and was scoring low on her tests. She was also not sleeping. She has a fit-bit and averaging between 3-1/2 to 4 1/2 hours of sleep. She just felt out of it and this was through the month of April. Then on 5/8/21 she felt like something was in her eye, she had dyed her hair and put eye drops in her eye. She did correlate anything with the vaccine yet. Then Sunday morning (Mother's day), she observed something and was so tired and decided to go back to sleep. Then she woke up and the eye and the face started twisting and was paralyzed on the left side. Her speech was not clear and the automatic thing was to speak slower and it would fix itself, and what was going on. (She had a prior TIA). She thought of a stroke coming to mind, and decided she needed to take action and went to the ER by ambulance. Once she was in the ER, they did an EKG, did CT scan and an MRI to see if there was anything going on for a stroke or sign of a stroke, which there was not according to the paperwork and results. Not felt to be related to her heart either. They diagnosed her with Bell's palsy and sent her results to a neurologist for them to do their assessment. They were relieved that it was not a stroke. She went to the neurologist the following week and felt that there seemed to be some white matter on her CT. She finished the medication that she was given, and was told that he was going to do a phone appointment, and she refused to have that and said that he could not see the differences in her face and the progress over the phone. She was not able to breath out of her left nostril and was getting worse, having pain and wanted to find answers and they did see her in the office. They did EMG's, checked her eyes and said that she was fine, and asked why did it seem that it was getting worse. She felt like her skin was coming off her spine, and feels a pull. He suggested doing an MRI of her spine and her face, and suggested an EMI to see if there was damage to her nerves. She had shingles in the past and was already having difficulties lifting her arm and had suggestions. She also saw her acupuncturist who did not touch her face and did needling on her body and she was able to swallow better, and was informed not to do them on her face. She also had a telemed APT and was OK'd to have acupuncture on her head but again not her face. She was still on the steroids, and had information and paperwork that she had researched and asked him questions to educate her and help her. Her daughters have been doing research and told her that maybe she needed a different neurologist. She called the nurse line at the clinic who advised her to stay where she was and see what he had to offer. She is doing warm towels in the morning and evening and she?s able to get some relief and sleep. She finds that her brain is working better and that it is going to take some time for this to heal. She had testing for AVM?s during her chemo and she had no indication for that. In November and December 2019, she was really sick with URI and was on breathing treatments and was one step away from pneumonia and was not able to work. She took an antibodies test in March and had antibodies. She then had COVID in her household in December of 2019, but was tested several times and tested negative for that. She was diagnosed with cancer when she hit her head on a cabinet at work, and noticed that she had scarring, which she thought was from chicken pox and shingles. Her chicken pox left scars on her lungs and she did not take medication for that due to driving her kids back and forth to school and not wanting to be under medication effects. The ER followed up with her after telling her that she needed to see a doctor. She went to a cancer center and had biopsies and they lost her specimens at the hospital. She ended up having to get another test and was diagnosed with a very aggressive cancer, and told her she needed surgery. She had laparoscopic thoracic surgery and they removed 3/4 of her lung. She had chemo for 5-6 months, and was antibiotics the entire time due to infections. At one point she was excreting skin from the chemo. They inadvertently found out that a nurse had given other patient's wrong chemo and was fired from being a chemo nurse. She has been under a great deal of stress. Now since doing the warm towels her symptoms are better, the nerve is not as tight. It goes from the top of her brow all the way to her chin on the left side, it goes in sections. It was in the middle first, from there it goes up above and bulges on the top of her brow, and then with warm towels it progresses to a bulge on her face. She can't breath out of her left nostril and uses saline to keep it moisturized. She can blow her nose if she pulls her nose towards the left. She uses the salt water rinses in her mouth as she feels everything is pulling to the right including her neck. She was given a salve from her acupuncturist that has helped as well. She does self pictures throughout the day to see her progress of this process.
62 2021-05-25 sleep disorder 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 2021-05-27 feeling abnormal Patient presented to vaccine clinic for second covid vaccine. Following first dose, patient had mild... Read more
Patient presented to vaccine clinic for second covid vaccine. Following first dose, patient had mild side effects in the observation area after the first dose of the covid, where she was observed in our reaction room area more closely, for feeling foggy and "just not right", however patient was fine to be able to be sent home. Patient was encouraged to contact physician to verify they should receive second covid vaccine. When patient was in observation area, after receiving her second covid vaccine shot, she told the observation nurse that she had a headache. The nurse immediately took her to our reaction room area and was closely observed. Patient was talking and acting fine. Within minutes, she started to have a seizure. Documentation in patient's chart regarding incident. Patient then transferred via ambulance to ED. Per EMS patient had 5-6 seizures requiring 4mg Ativan IM. Patient reports she has seizures, is seen by Neurology and takes Keppra and Depakote. On further documentation review, patient was seen by Neurology and was felt to not have seizures. She was also seen by psychiatry who noted that patient most likely has psychogenic nonepileptic seizure-like activity. Patient observed in the ED without further symptoms or episodes. Discharged to home.
62 2021-05-30 delirium 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 disturbance in attention, depression, emotional distress, impaired work ability I COULDN'T THINK CLEARLY, EXTREMELY EMOTIONAL, HIGH MANIC FOR THREE TO FOUR HOURS, THEN CRASHED INTO... Read more
I COULDN'T THINK CLEARLY, EXTREMELY EMOTIONAL, HIGH MANIC FOR THREE TO FOUR HOURS, THEN CRASHED INTO DEPRESSION (THIS TYPE OF EPISODE NEVER HAPPENED BEFORE), LOSS OF HOPE, DEPRESSION HIGHER THAN N0RMAL, BAD JUDGEMENT AT WORK CAUSED LOSS OF CLIENT'S BUSINESS. I KNEW MY PSYCHOTROPIC MEDICINES WERE NOT WORKING AND THOUGHT I WAS GOING INSANE. OR MAYBE EARLY ONSET DEMENTIA.
62 2021-06-01 feeling abnormal Nausea dizzy lost 16 lbs tingles in head legs face two weeks after second dose still continues
62 2021-06-01 feeling abnormal 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 feeling abnormal Magnets stuck to her arm; Worse chills; Arm still hurts; 2 inches below the injection site there was... Read more
Magnets stuck to her arm; Worse chills; Arm still hurts; 2 inches below the injection site there was a red spot which had since turned into a scar; Her arm swelled up; 104.3 degree F fever; Low pulse oxygen level of 77%/Breathing was worse than before the vaccination; Didn't feel good all weekend until Sunday; 2 inches below the injection site there was a red spot which had since turned into a scar; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (104.3 degree F fever) in a 62-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 Breast cancer (5 years ago) in 2016, COVID-19 (hospitalized 01-Nov-2020) on 28-Oct-2020 and Pneumonia (almost died from pneumonia complications from COVID-19) on 01-Nov-2020. Concurrent medical conditions included Total lung capacity decreased (was left with 55% lung capacity after the pneumonia) since November 2020. Concomitant products included ALBUTEROL SULFATE for an unknown indication. On 29-Apr-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (104.3 degree F fever) (seriousness criterion medically significant), DYSPNOEA (Low pulse oxygen level of 77%/Breathing was worse than before the vaccination), VACCINATION SITE SCAR (2 inches below the injection site there was a red spot which had since turned into a scar), CHILLS (Worse chills), VACCINATION SITE ERYTHEMA (2 inches below the injection site there was a red spot which had since turned into a scar) and VACCINATION SITE SWELLING (Her arm swelled up). 29-Apr-2021, the patient experienced FEELING ABNORMAL (Didn't feel good all weekend until Sunday). 29-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm still hurts). On 22-May-2021, the patient experienced VACCINATION SITE REACTION (Magnets stuck to her arm). On 30-Apr-2021, PYREXIA (104.3 degree F fever), DYSPNOEA (Low pulse oxygen level of 77%/Breathing was worse than before the vaccination) and CHILLS (Worse chills) had resolved. On 02-May-2021, FEELING ABNORMAL (Didn't feel good all weekend until Sunday) had resolved. On 20-May-2021, VACCINATION SITE SWELLING (Her arm swelled up) had resolved. At the time of the report, VACCINATION SITE SCAR (2 inches below the injection site there was a red spot which had since turned into a scar), VACCINATION SITE REACTION (Magnets stuck to her arm) and VACCINATION SITE ERYTHEMA (2 inches below the injection site there was a red spot which had since turned into a scar) outcome was unknown and VACCINATION SITE PAIN (Arm still hurts) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Oxygen saturation: 77 (Low) 77%. On 29-Apr-2021, Pyrexia: 104.3 degree f (High) 104.3 degree F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment provided were Tylenol. Follow-up received on 25MAY2021 included no new information. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information.
62 2021-06-02 insomnia, feeling abnormal 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 sleep disorder pt states as soon as the needle went into her arm it hurt very badly. She waited her 15 minutes and... Read more
pt states as soon as the needle went into her arm it hurt very badly. She waited her 15 minutes and when she started walking away she got a headache and was very weak, tired and sleepy. As time went by her arm was still very sore and became very itchy at the injection site. It has been been 3 months since she has had the vax and the arm still has a pain at the injection. She cannot lift anything heavy because it is too painful and she cannot sleep on the left side. Pt will contact her PCP for medical advice.
62 2021-06-03 sleep disorder, agitation 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 confusional state 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 2021-06-08 delirium 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 feeling abnormal 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 2021-06-09 impaired work ability AFTER THE FIRST INJECTION THERE WAS NO REACTION. AFTER THE SECOND INJECTION STARTING 8 HOURS AFTER T... Read more
AFTER THE FIRST INJECTION THERE WAS NO REACTION. AFTER THE SECOND INJECTION STARTING 8 HOURS AFTER THE INJECTION SHE HAD SEVERE MUSLCE WEEKNESS AND COULD NOT MOVE. SHE HAD A FEVER GREATER THAN 101 AND PIERCING PAIN IN THE HEAD AND MUSLCE ACHES THAT LASTED ABOUT 48 HOURS. SHE HAD TO CALL OFF OF WORK. ABOUT 12 DAYS AFTER THE 2ND INJECTION SHE DEVELOPED REDNESS, TENDERNESS, SWELLING IN THE LOWER LEGS. WENT TO MED EXPRESS AND A DOPPLER WAS DONE FOR BLOOD CLOT. IT WAS NEGATIVE. THEY SYMPTOMS PROGRESSED AND SHE WENT TO HER PCP. DIAGNOSED WITH CELLULITIS AND WAS PUT ON KEFLEX. UPON EXAM YESTERDAY IN OUR OFFICE IT WAS CONFIRMED THAT SHE HAS ERYTHEMA NODOSUM.
62 2021-06-11 feeling abnormal, thinking abnormal 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 disturbance in attention, feeling abnormal 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 2021-06-13 depression, anxiety, emotional distress She had severe mental distress, paranoia and anxiety with severe depression which has gradually abat... Read more
She had severe mental distress, paranoia and anxiety with severe depression which has gradually abated until today (6/14/21) she is off additional medication.
62 2021-06-13 feeling abnormal, impaired work ability 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 2021-06-13 loss of personal independence in daily activities I started feeling pain at the injection site the afternoon ofn1/172021. The pain would not allow me... Read more
I started feeling pain at the injection site the afternoon ofn1/172021. The pain would not allow me to do any of my normal activities on that day. I went to bed around 9:00 PM that night; however, by 11:00 PM on that date the pain at the injection site was so excruciating that I woke up and called the Clinic nurse on demand as my pain level was 8. The nurse told me to take some Advil and to ice my arm. I took the Advil and ice my arm.
62 2021-06-14 delirium Cellulitis in arm; Arm has a bruise that is getting larger over time; Swollen arm bright red in colo... Read more
Cellulitis in arm; Arm has a bruise that is getting larger over time; Swollen arm bright red in color, hot to the touch; Swollen arm bright red in color, hot to the touch; Swollen arm bright red in color, hot to the touch; Fever of 103.8 degrees Fahrenheit; Vomiting; words slurring; Sweating profusely; Became truly delirious; Scab at the site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DELIRIUM (Became truly delirious) in a 62-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. Concurrent medical conditions included Guillain Barre syndrome and Cutaneous lupus erythematosus. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), TOPIRAMATE (TOPAMAX), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), IMMUNOGLOBULINS NOS and LISDEXAMFETAMINE MESILATE (VYVANSE) 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 21-May-2021, the patient experienced VACCINATION SITE SCAB (Scab at the site of injection). On 22-May-2021, the patient experienced DELIRIUM (Became truly delirious) (seriousness criterion medically significant), DYSARTHRIA (words slurring), HYPERHIDROSIS (Sweating profusely), PYREXIA (Fever of 103.8 degrees Fahrenheit) and VOMITING (Vomiting). On 23-May-2021, the patient experienced CELLULITIS (Cellulitis in arm), INJECTION SITE BRUISING (Arm has a bruise that is getting larger over time), VACCINATION SITE WARMTH (Swollen arm bright red in color, hot to the touch), VACCINATION SITE SWELLING (Swollen arm bright red in color, hot to the touch) and VACCINATION SITE ERYTHEMA (Swollen arm bright red in color, hot to the touch). The patient was treated with CEFTRIAXONE (CEFTIN [CEFTRIAXONE]) ongoing since an unknown date for Cellulitis, at an unspecified dose and frequency; ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Fever, at a dose of UNK dosage form. On 22-May-2021, DELIRIUM (Became truly delirious), DYSARTHRIA (words slurring), HYPERHIDROSIS (Sweating profusely) and VOMITING (Vomiting) had resolved. On 23-May-2021, PYREXIA (Fever of 103.8 degrees Fahrenheit) had resolved. On 24-May-2021, CELLULITIS (Cellulitis in arm), VACCINATION SITE WARMTH (Swollen arm bright red in color, hot to the touch), VACCINATION SITE SWELLING (Swollen arm bright red in color, hot to the touch) and VACCINATION SITE ERYTHEMA (Swollen arm bright red in color, hot to the touch) had resolved. At the time of the report, INJECTION SITE BRUISING (Arm has a bruise that is getting larger over time) and VACCINATION SITE SCAB (Scab at the site of injection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, Body temperature: 103.8 (High) 103.8 degrees Fahrenheit. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event included intravenous fluids in Emergency Room. Based on the current 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 04-Jun-2021: contained significant information: lot number updated. On 08-Jun-2021: non-significant information: contact 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. Further information has been requested.
62 2021-06-17 feeling abnormal 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 2021-06-23 impaired work ability 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 2021-06-25 impaired work ability Low grade fever and extreme drowsiness. I slept for 12 hours straight after 2nd shot at 4:30 pm the ... Read more
Low grade fever and extreme drowsiness. I slept for 12 hours straight after 2nd shot at 4:30 pm the day prior and a difficult day at work!
62 2021-06-26 impaired work ability per tp had dizziness within an hour and nausea and vomiting, also report muscle rigidity in vaccinat... Read more
per tp had dizziness within an hour and nausea and vomiting, also report muscle rigidity in vaccination site. Pt was too fatigued to work or get out of bed for 5 days .
62 2021-06-29 impaired work ability 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 2021-06-30 impaired work ability Pure and absolute exhaustion, Almost fainted due to the exhaustion, Stayed in bed for three days, Af... Read more
Pure and absolute exhaustion, Almost fainted due to the exhaustion, Stayed in bed for three days, After the third day, I started feeling fine and went back to work.
62 2021-07-01 sleep disorder Regular fever symptoms and tiredness Abdominal pain kept me awake the whole night Doctor prescribed ... Read more
Regular fever symptoms and tiredness Abdominal pain kept me awake the whole night Doctor prescribed Prilosec Hours later I started vomiting and had severe abdominal pain Diagnosed with pancreatitis and splenic artery aneurysm Treatment: An anti-nausea medication and a shot of Toradol I was recommended to do a one week clear liquid diet
62 2021-07-08 crying, feeling abnormal, loss of personal independence in daily activities 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 2021-07-08 excessive sleepiness Patient states she has had episodes of fatigue that started after her second Moderna shot - She rep... Read more
Patient states she has had episodes of fatigue that started after her second Moderna shot - She reports she was fatigued and slept excessively "once in bed, there I stay" from 5/11 through 5/14. After this she felt back to her normal state. She went out of state and enjoyed herself. Then again 05/30 through 06/04 she had a recurrence of fatigued and slept excessively - she chalked this up at that time from overdoing it when she was in state. On the 5th she was back to her normal state. Then 6/22 she felt extremely tired and fatigued - and it lasted through 6/24 - "I fell asleep and couldn't wake up again" Then she was back to her normal again. On 7/6 about 11:00 she has symptoms recur - and this morning (7/9) she woke up and felt back to her normal.
62 2021-07-10 impaired work ability Woke up the following day of injection to a red, swollen and hard spot where injection happened. Red... Read more
Woke up the following day of injection to a red, swollen and hard spot where injection happened. Red spot was size of golf ball.. I was told by pharmacist to administer benadryl creme to area.. within an hour, I was fatigued, so much so that I had to leave work early. I took nap after going home and started getting chills.. Took my temperature orally and is 100.3 Muscle aches and weakness right now..
62 2021-07-12 fear 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 impaired work ability 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 2021-07-14 sleep disorder 1/11/21: neck and shoulder stiffness and arthritis-like pain starts and continues until Prednisolone... Read more
1/11/21: neck and shoulder stiffness and arthritis-like pain starts and continues until Prednisolone dose pack 4/28/21. Stiffness and pain resumes in May-July but not as bad. 1/17/21: one week after 1st vaccine see large (egg size) swelling at injection site that lasts a few days. 1/20/21: numbness and tingling in right hand, especially in mornings. Much worse if I sleep on side. 1/28/21: Saw Chiropractor, thinking I had pinched nerve in neck (previous MRI showed disk bulges at C5-6 and C6-C7). Numbness and symptoms continue. Heat or ice no help. Must sleep flat on back with no pillow to prevent numbness/tingling. 2/27: 2nd Moderna vaccine, little swelling. Stiffness in neck/shoulder continues. Numbness and tingling start in left hand as well as right. 3/10/21: Saw Dr. (Orthopedic Surgeon), prescribed Gabapentin and PT. Gabapentin no help, PT including traction to stretch neck, and new exercises temporarily help with neck stiffness and numbness and tingling, but symptoms return. 3/27 Hands (BOTH) and fingers extremely stiff and bent in morning, painful and difficult to flex. Never had arthritis in hands previously. 4/7/21: televisit with (PCP), recommended RA test (negative) and prescribed Tizanidine (helps me get to sleep). Recommended follow up with neurologist (MS). March-July: arthritis symptoms in hands every norming, numbness and tingling in fingers almost continuous. Noticable increased pain in knees when squatting. 4/24: some numbness and tingling in butt and feet when laying down flat. 4/28/21: Saw my neurologist (Dr.) out of concern that these were new MS symptoms. ( I had stopped taking Betaseron in December 2020). Recommended MRI of head and neck, which showed no new lesions indicative of MS exacerbation. Prescribed dose pack of Prednisolone which helped relieve stiffness and pain in neck and shoulders (it returns later, but not as bad). Recommended EMG. 6/18/21: Saw Milvia Yadira Pleitez, for EMG which indicated bilateral carpal tunnel syndrome. 6/22/21 Saw Dr. EMG shows sensory and auto nerves affected on R hand, sensory only on left hand. Wear wrist braces for 12 weeks, then steroid shots if necessary, then surgery. Knee xray shows no abnormalities. Physical therapy for knee available. Arthritis in hands/knee may be related to COVID vaccine. 6/22-7/10: Taking Naproxen about every other night, muscle relaxant only when stiff. Neck and shoulder better but still stiff. Can sleep on side for limited time. Fingers still numb, no improvement with hand braces. Hand pain and stiffness in a.m. Knee pain when squatting continues.
62 2021-07-17 insomnia, crying legs are in so much pain, it feels like they are hot, buzzing and sunburned; Feet are very cold in t... Read more
legs are in so much pain, it feels like they are hot, buzzing and sunburned; Feet are very cold in the inside/ It feels like she has a bag of rice in her feet and feels like she has been shoveling without shoes for hours; Couldn't sleep in April and May; Would just cry and pray since she was in pain; Pain in her legs and numbness almost like they were falling asleep; Her little pinky felt like it got a cut and she fears that it is going to her heart or brain; bag of rice in her feet; A pins and needle sensation in her legs which went up to her thighs in 2-3 days, and to her hands in a few days; her legs are in so much pain; She walked a little slower compared to her friends who are taller than her/ difficulty with walking, how her legs go ou; Arms was sore; Had some trouble raising her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her legs are in so much pain) 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 Hospitalization (Uncontrolled diabetes mellitus). Concurrent medical conditions included High cholesterol, Hypertension and Diabetes. Concomitant products included INSULIN 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 15-Apr-2021, the patient experienced MOBILITY DECREASED (Had some trouble raising her arm) and VACCINATION SITE PAIN (Arms was sore). On 11-May-2021, the patient experienced PAIN IN EXTREMITY (her legs are in so much pain) (seriousness criterion disability) and GAIT DISTURBANCE (She walked a little slower compared to her friends who are taller than her/ difficulty with walking, how her legs go ou). On an unknown date, the patient experienced PARAESTHESIA (A pins and needle sensation in her legs which went up to her thighs in 2-3 days, and to her hands in a few days), SKIN DISCOMFORT (Her little pinky felt like it got a cut and she fears that it is going to her heart or brain), FEELING HOT (legs are in so much pain, it feels like they are hot, buzzing and sunburned), PERIPHERAL COLDNESS (Feet are very cold in the inside/ It feels like she has a bag of rice in her feet and feels like she has been shoveling without shoes for hours), INSOMNIA (Couldn't sleep in April and May), CRYING (Would just cry and pray since she was in pain), HYPOAESTHESIA (Pain in her legs and numbness almost like they were falling asleep) and DYSAESTHESIA (bag of rice in her feet). At the time of the report, PAIN IN EXTREMITY (her legs are in so much pain) had not resolved and PARAESTHESIA (A pins and needle sensation in her legs which went up to her thighs in 2-3 days, and to her hands in a few days), SKIN DISCOMFORT (Her little pinky felt like it got a cut and she fears that it is going to her heart or brain), GAIT DISTURBANCE (She walked a little slower compared to her friends who are taller than her/ difficulty with walking, how her legs go ou), FEELING HOT (legs are in so much pain, it feels like they are hot, buzzing and sunburned), PERIPHERAL COLDNESS (Feet are very cold in the inside/ It feels like she has a bag of rice in her feet and feels like she has been shoveling without shoes for hours), INSOMNIA (Couldn't sleep in April and May), CRYING (Would just cry and pray since she was in pain), HYPOAESTHESIA (Pain in her legs and numbness almost like they were falling asleep), MOBILITY DECREASED (Had some trouble raising her arm), DYSAESTHESIA (bag of rice in her feet) and VACCINATION SITE PAIN (Arms was sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was used to take cholesterol and hypertension medications but that was discontinued a few years ago. Patient was hospitalized in the ICU on 21MAR2021 to 23MAR2021. Patients treatment product details were 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. This case was linked to MOD-2021-243093 (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 2021-07-19 feeling abnormal 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 2021-07-20 anxiety Cant not write; Cannot walk up the stairs, she used to walk "4 miles a day in winter time (30,000 st... Read more
Cant not write; Cannot walk up the stairs, she used to walk "4 miles a day in winter time (30,000 steps) but now zero; Cannot get out of bed feels like she is 100 years old; Arms, knees, elbows and ankles feel like being crippled; Anxiety went through the roof; Joint pain continued to intensify; Rheumatoid arthritis; Arthritis flared up when she got the vaccine; She was so cold, could not get warm; Teeth were chattering; fever of 104.5F; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis), DYSGRAPHIA (Cant not write), GAIT INABILITY (Cannot walk up the stairs, she used to walk "4 miles a day in winter time (30,000 steps) but now zero), MOVEMENT DISORDER (Cannot get out of bed feels like she is 100 years old) and HYPOKINESIA (Arms, knees, elbows and ankles feel like being crippled) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma, Arthritis, Drug allergy (Aspirin Allergy) and Drug allergy (Advil Allergy). On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced FEELING COLD (She was so cold, could not get warm), CHILLS (Teeth were chattering) and PYREXIA (fever of 104.5F). On 16-Jul-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Arthritis flared up when she got the vaccine). On an unknown date, the patient experienced DYSGRAPHIA (Cant not write) (seriousness criterion disability), GAIT INABILITY (Cannot walk up the stairs, she used to walk "4 miles a day in winter time (30,000 steps) but now zero) (seriousness criterion disability), MOVEMENT DISORDER (Cannot get out of bed feels like she is 100 years old) (seriousness criterion disability), HYPOKINESIA (Arms, knees, elbows and ankles feel like being crippled) (seriousness criterion disability) and ANXIETY (Anxiety went through the roof). an unknown date, the patient experienced ARTHRALGIA (Joint pain continued to intensify). On 16-Apr-2021, PYREXIA (fever of 104.5F) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and ARTHRALGIA (Joint pain continued to intensify) had not resolved and DYSGRAPHIA (Cant not write), GAIT INABILITY (Cannot walk up the stairs, she used to walk "4 miles a day in winter time (30,000 steps) but now zero), MOVEMENT DISORDER (Cannot get out of bed feels like she is 100 years old), HYPOKINESIA (Arms, knees, elbows and ankles feel like being crippled), ANXIETY (Anxiety went through the roof), CONDITION AGGRAVATED (Arthritis flared up when she got the vaccine), FEELING COLD (She was so cold, could not get warm) and CHILLS (Teeth were chattering) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 104.5 °F (High) 104.5°F. On an unknown date, Blood test: has autoimmune disorder (abnormal) Blood works revealed that she now has an autoimmune disorder. Concomitant medications were 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. Concomitant medical conditions (arthritis) could be potentially confounders/co-suspects for the 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. Concomitant medical conditions (arthritis) could be potentially confounders/co-suspects for the events.
63 2021-01-03 feeling abnormal 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 sleep disorder, disturbance in attention, excessive sleepiness about 2:45 pm on 12/29/2020 I because extremely fatigue to the point I couldn't concentrate. I could... Read more
about 2:45 pm on 12/29/2020 I because extremely fatigue to the point I couldn't concentrate. I couldn't figure out why as I got proper sleep the night before so powered through until leaving work at 4 pm. When I got home I ate a small amount, I wasn't hungry and went to bed at 5 pm and slept through until 6 am. during the night I noticed my arm bothering me, itchy but didn't get up to check on it. When I woke this a.m. my arm had a big red bump, warm to the touch and itchy so now I'm convinced the fatigue was related to the COVID vaccine. I feel fine, I am not tired today but I am aware of my arm and it is itchy. I am surprised this happen a week later.
63 2021-01-03 sleep disorder 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 feeling abnormal Muscle pain at injection site, fatigue, became very cold without chills, fever, headache, nausea, he... Read more
Muscle pain at injection site, fatigue, became very cold without chills, fever, headache, nausea, head fog
63 2021-01-07 sleep disorder unable to sleep, photo sensitive, lack of appetite and migraine.
63 2021-01-09 feeling abnormal, confusional state Within 1 h, pain from injection site to neck. Neck pain felt like meningitis pain. Diarrhea, general... Read more
Within 1 h, pain from injection site to neck. Neck pain felt like meningitis pain. Diarrhea, generalized not feeling fell. On awakening 01/09/21, low grade fever of 99.9, chills, fatigue, generalized malaise, brain fog, & confusion. I was in the shower & yelled for my husband to help me brush my wet hair & asking why it was wet. When I was brushing my teeth, I asked my husband to get me a toothbrush because I could not brush my teeth with "this noodle". Doing "goofy" things on 01/09/21 & 01/10/21. Realizing I am doing this which is not normal. I am an RN & this is not normal for me. On 01/07/21 @ 6:30 pm took 50mg Benadryl, 200mg Advil & Tylenol
63 2021-01-09 impaired work ability Waking up at 02:00 on 01/08/21 with chills. all 4 extremities where shaking I was that cold.. temp o... Read more
Waking up at 02:00 on 01/08/21 with chills. all 4 extremities where shaking I was that cold.. temp of 100.4. weak. stayed home from work. then on 01/09/21 I spent all day in bed as well. very tired. my arm was VERY painfull when touched or would try to use it.
63 2021-01-11 confusional state, feeling abnormal Thursday, Jan. 7, 2021 I felt a little strange. Just not myself. A little dizzy. Went to work over... Read more
Thursday, Jan. 7, 2021 I felt a little strange. Just not myself. A little dizzy. Went to work overnight. Got up at 5 am Friday, Jan 8, 2021. Still felt odd. Dizzy. Had to think before I did anything. I stood up from the bed and sat back down again as if I was dizzy and confused. Drove myself home from work, fed the cats and went right to bed. I felt very fatigued, had developed a monster headache. Was dizzy, had chills, body aches, nausea. I brought water bottle over to the bed with me but after laying down just could not get myself up to get a drink. Felt very fatigued. Slept until 2 pm. Took my temperature. It was 101.5. Had no energy, ate no food, took no meds, just went back to sleep. Still nauseous, had headache, dizziness, fatigue, body aches, chills. Woke up at 5:00 pm to feed cats. That?s all I did, and go to the bathroom. Took my temperature again. It was 100.9. Still felt awful: nauseous, headache, dizziness, fatigue, body aches, chills. Seemed like I could not get warm. Stayed in bed and slept. Saturday, Jan. 9, 2021 I woke up around 7:30 to go to the bathroom. I fed the cats also. Still dizzy, moving slow. My headache was gone, but still felt unsteady. After feeding the cats, I went back to bed. Slept until 12:30 that afternoon.
63 2021-01-11 feeling abnormal After receiving my shot on Friday, my arm began to get sore, my ears felt like they were on fire. I... Read more
After receiving my shot on Friday, my arm began to get sore, my ears felt like they were on fire. I woke up on Saturday and my arm soreness had increased. Later that evening I went to bed and was awoken with extreme pain in my back and neck. It felt as if it may be serve nerve pain. It lasted all day Sunday, with light headiness. On Monday, I continued to have muscle tightness and soreness throughout my back; later in the evening my stomach started to hurt and I was extremely nausea. Today Tuesday, I continue to feel out of sorts, with upset stomach and muscle fatigue. No treatment as I do not know who to speak to.
63 2021-01-11 loss of personal independence in daily activities, impaired work ability ? injection site pain ? tiredness ? headache ? muscle pain ? chills ? joint pain ? fever ? in... Read more
? injection site pain ? tiredness ? headache ? muscle pain ? chills ? joint pain ? fever ? injection site swelling ? injection site redness ? nausea ? feeling unwell A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions i.e. slept 2 days straight, missed work Increased asthma medication used rescue inhalers
63 2021-01-12 impaired work ability 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 2021-01-12 impaired work ability Almost immediately after receiving the vaccine, I felt a headache, throat scratchiness, numbness to ... Read more
Almost immediately after receiving the vaccine, I felt a headache, throat scratchiness, numbness to fingers on right hand and discomfort at injection site. Within 2 hours, I could not continue to work and went home. Took motrin at home and rested. The following morning the headache was mild but the injection site was very painful. No reddness or swelling, not firm but extremely tender to touch. Pain at injection site was present for 2 days then resolved slowly..
63 2021-01-18 memory impairment 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 2021-01-19 sleep disorder Awoke 3:30 am next day(approx. 13 hours post injection)from sound sleep with strange feeling in my t... Read more
Awoke 3:30 am next day(approx. 13 hours post injection)from sound sleep with strange feeling in my tongue. Felt swollen, but dont think it was, burning sensation on lateral borders and tip of tongue,extremely dry mouth. Felt as though it had also been burned, and had a few white spots on tip, reddened borders on lateral aspects also, very scallopededges. Note I do have a fissured tongue but this reaction was unlike any I had ever had from eating certain foods that trigger any tongue response, and had not eaten anything night before to trigger this. Lasted a few days and progressively felt normal after 3-4 days.
63 2021-01-20 disturbance in attention Arm pain, fever, chills, headache, body aches, hard to concentrate
63 2021-01-21 panic attack dizziness, lightheaded, panic attack; seen & cleared by EMS. B/P-184/98, P-79; repeat B/P-165/94 and... Read more
dizziness, lightheaded, panic attack; seen & cleared by EMS. B/P-184/98, P-79; repeat B/P-165/94 and client took own anxiety medication, Klonopin as directed by EMS.
63 2021-01-24 impaired work ability Two days after shot had throbbing pains in arm and 4 days later it got worse and started to travel ... Read more
Two days after shot had throbbing pains in arm and 4 days later it got worse and started to travel to left side. through my left arm, spinal cord, left side and shoulder blade. went on for a little over two and half weeks. so severe i had to miss work. the last thing i had vibration in left arm like it went to sleep and started to wake up. have been dealing with this since then. it happens randomly through out the day. Still have pain in the upper arm and cant lay on my left arm for more then a few minutes. and it is swollen at the injection site
63 2021-01-25 feeling abnormal 14 hours of Fever 100.4 degrees, pain in back, neck, arm, chills. The fatigue and brain fog cont... Read more
14 hours of Fever 100.4 degrees, pain in back, neck, arm, chills. The fatigue and brain fog continued for 4 days. All reactions resolved.
63 2021-01-25 sensation of foreign body 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 sensation of foreign body 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 2021-01-26 amnesia, confusional state Mental confusion and short term memory loss, weakness and numbness in left hand. Numbness and weakne... Read more
Mental confusion and short term memory loss, weakness and numbness in left hand. Numbness and weakness improved after 2 days. Mental fog continued until Jan. 25th. First day I actually felt normal was 1/26,2021.
63 2021-01-26 feeling abnormal Client immediately "felt like a ball was rolling up my neck, left side of face, throat pain, runny n... Read more
Client immediately "felt like a ball was rolling up my neck, left side of face, throat pain, runny nose and trouble swallowing." She denies SOB or any breathing difficulties. 1/5/21 Seen in urgent care and dx with sinus infection. Given Amoxicillin for 10 day. Runny nose continued. Seen in urgent care on 1/23/21 and started on doxycycline and prednisone. Says today is the first day she has felt better. She was due for her 2nd vaccine today but is not going to take it.
63 2021-01-26 feeling abnormal Dizziness, fast heartbeat, lips felt funny like they were thick, headache, and tongue felt thick.
63 2021-01-26 impaired work ability Chills, head ache, no treatment, missed a day of work
63 2021-01-26 impaired work ability 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 sleep disorder One hour post inject loose bowels, six hours post inject arm site pain, ten hours post inject pain ... Read more
One hour post inject loose bowels, six hours post inject arm site pain, ten hours post inject pain radiating to entire body from head to toes causing fingers and toes to be numb, twelve hours post inject migraine headache with dry heaving and some vimitting, ( no sleep) twenty hours post inject flu like symptoms of body aches and stomach sickness for 24 hours. 48 hours later another migraine headache. PCP aware of all these symptoms.
63 2021-01-27 feeling abnormal Very achy all over. Tired. Whole body aches. Typical fibromyalgia but more severe than normal. I did... Read more
Very achy all over. Tired. Whole body aches. Typical fibromyalgia but more severe than normal. I didn?t feel well mid day the day prior. Still wasn?t better Monday the day of shot, I feel much worse now.
63 2021-01-27 feeling abnormal Received the immunization @8:00 PM on 1/25/2021. On 1/26/2021, woke @07:00 feeling chilly, dizzy and... Read more
Received the immunization @8:00 PM on 1/25/2021. On 1/26/2021, woke @07:00 feeling chilly, dizzy and headache behind my eyes. My energy level was very low too. Took my temperature @ 09:00 and it was 101.1. I took Aspiring @325 mg every 4-6 hours plus used cold wet cloths to calm my fever down. I was not able to walk or drive a car with confidence. Also, I had painful sensation with lights on. No appetite--Did not eat anything until 1/27/2021 in the afternoon. On 1/27/2021, my hunger came back and fever down to normal. I was able to drink juices and eat some soup. Today, I had some breakfast of Tofu and scrambled eggs. But still feel a bit "floaty."
63 2021-01-27 impaired work ability No symptoms initially, then 3-4 hours having itching which got worse. 1/27/21 reaction was on face ... Read more
No symptoms initially, then 3-4 hours having itching which got worse. 1/27/21 reaction was on face on the right side. Last night the ears on the ride was red and having swelling. Taking Benadryl (advised by son who is dr), cortisone with itching. Not able to go to work due to side effects from taking the Benadryl. Does have a call-in to her doctor. Saw on website which said to have an injection of Benadryl and/or Cortisone which is waiting on instructions from him.
63 2021-01-27 insomnia, feeling abnormal 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 2021-01-28 feeling abnormal 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 excessive sleepiness 1/25/2021- severe pain at vaccination site, I could not move my arm, was unable to sleep. 1/26/2021-... Read more
1/25/2021- severe pain at vaccination site, I could not move my arm, was unable to sleep. 1/26/2021- dizzy, achy, chills, fever 101.8 degrees to 102.6 degrees. 1/27/2021- slept most of the entire day, achy, dizzy. 1/28/2021 & 1/29/2021- fatigue.
63 2021-01-28 sleep disorder About 14 hours after vaccination, I had a (really bad) pulsating headache in a band around my head, ... Read more
About 14 hours after vaccination, I had a (really bad) pulsating headache in a band around my head, body aches (hip flexors, shoulders, back, neck), chills, fever/sweats, and nausea/vomiting (threw up twice, total, about an hour or two apart after not eating for 10 hours - small amount of liquid came up). The nausea/vomiting went away about 4 hours after onset while the other symptoms remained for an additional 42 hours. I also had sinus/eye pressure that began about 22 hours after vaccination and ended with the other symptoms. Could not sleep for the duration because of headache. Very tired/sleepy about 62 hours after injection and was able to nap since headache went away. I still have soreness at injection site about 72 hours after injection. I would say the worst part of this was the headache because it was so bad, I couldn't sleep or do anything while I had it - I had read that NSAIDs might reduce the uptake of the vaccine so didn't want to take any. Therefore, there was no way to get rid of the headache and it was very unpleasant for almost 3 days. The next worst was the nausea/vomiting, because, well, nausea/vomiting, and especially because there was nothing to bring up. And, unlike vomiting from bad food or something, you don't really feel better afterward, just still nauseated. The other symptoms were more bearable. Did not call or see doctor because I had read about these possible side effects and didn't think there was anything the doctor could do to alleviate them.
63 2021-01-29 feeling abnormal 5 hours after receiving injection, I had severe arm pain from shoulder to elbow on side shot was giv... Read more
5 hours after receiving injection, I had severe arm pain from shoulder to elbow on side shot was given, woke up next morning with brain fog, extreme fatigue, and feverish feeling, but no temp. Concerned because of my autoimmune disease. Worried about second shot in four weeks.
63 2021-02-01 abnormal dreams 1/28/21: Tingling at sides of tongue within 10 minutes (had this after vaccine #1, too). A warm rus... Read more
1/28/21: Tingling at sides of tongue within 10 minutes (had this after vaccine #1, too). A warm rush up the back of my neck. 1/29/21: Pain at site of injection. Chills, fever, aches, extreme fatigue and sleepiness. During night had racing, repetitive dreams. Experienced polyuria, with diuresis resulting in 10 pound weight loss over 3 days. 1/30/21: Extreme fatigue and sleepiness, chills, aches, nausea, diarrhea 1/31/21: Fatigue, headache but only with cough, pain at back of my neck and skull 2/1/21: Fatigue, headach but only with cough, pain at top of my head and toward the front of my skull. 2/2/21: Mild fatigue, head pressure at temples and top of my head and toward the front of my skull. Mild roaring in my left ear, dizziness when I turn my head quickly. Neck is still somewhat stiff. 2/3/21: Anticipate being able to return to work
63 2021-02-01 insomnia, feeling abnormal, impaired work ability, loss of personal independence in daily activities Patient received vaccination and was observed for 15 minutes and was released after 15 minutes with ... Read more
Patient received vaccination and was observed for 15 minutes and was released after 15 minutes with no complications. Patient went home about 2 hours later noticed pain around injection site and swelling. (16:30) By 1930 patient states "she was in horrible pain and wanted to cry and couldn't remove her clothing for bed." She was unable to sleep that evening due to being in pain (continued)
63 2021-02-02 sleep disorder pt states her arm is very tender but no rash around the injection site but she woke up during the ni... Read more
pt states her arm is very tender but no rash around the injection site but she woke up during the night w/ extreme joint pain in lower back, hip, knees and ankles. Pt states she will probably not contact her PCP since she was advised that she may have some of these symptoms. Pt stated she started taking ibuprofen before covid vax and is still taking it.
63 2021-02-03 feeling abnormal 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 excessive sleepiness Had vaccine#2 at noon on the 4th. Woke up with 101 temp and body aches at 4:30 the next morning. T... Read more
Had vaccine#2 at noon on the 4th. Woke up with 101 temp and body aches at 4:30 the next morning. Temp is down with tylonol but back, neck, eyes... Especially back are extremely sure and achy. Slept at day with no energy
63 2021-02-04 sleep disorder woke throughout the night with body aches and headache, has also been fatigued
63 2021-02-05 crying, depression 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 2021-02-05 impaired work ability 6:00 a.m. on 2/5/21 I got up feeling nauseated. By 11:30 a.m. I also had body aches, fatigue, genera... Read more
6:00 a.m. on 2/5/21 I got up feeling nauseated. By 11:30 a.m. I also had body aches, fatigue, general malaise, and headache. I took the afternoon off work, went home and took Tylenol, and went to bed.
63 2021-02-06 panic reaction, anxiety 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 feeling abnormal Received the vaccine at 9:45 a.m. on 02/05/2021, felt fine until around 3:00 pm, when I noticed that... Read more
Received the vaccine at 9:45 a.m. on 02/05/2021, felt fine until around 3:00 pm, when I noticed that my right arm started hurting and then my knees became very achy and by the time I got home, I was feeling pretty bad. I took Tylenol along with my regular medications on Friday night. During the night I had trouble moving, because my body hurt so much and I had to keep peeing, which made it worse because I was having issues with moving, my eyes felt like they were bulging out of my head and I was very cold, so I did not want to get from under the covers. All day Saturday, I was in the bed sleeping. My daughter was worried that I was dying and wanted to take me to the hospital, but I told her it was the medicine working. I was sick until around 3 or 4 p.m. on Saturday, when I could feel a little difference in the way I was feeling. Sunday morning, I felt better, got up and went to the grocery store and came back in for the day, My head felt a little fuzzy intermittently during the day, but I did not do much and felt better.
63 2021-02-07 feeling abnormal nausea, tired, light headed, brain fog
63 2021-02-08 impaired work ability Myalgias, fever, headache occuring 24 hours later with slow improvement, severe enough to require ti... Read more
Myalgias, fever, headache occuring 24 hours later with slow improvement, severe enough to require time off from work
63 2021-02-08 sleep disorder, feeling abnormal I was woken up from sleep at 11:30 with swelling of my tongue. It was getting hard to breath, so I ... Read more
I was woken up from sleep at 11:30 with swelling of my tongue. It was getting hard to breath, so I got ice and sucked on it for awhile, then I put a cold cloth on my face, tried to relax and the swelling seemed ok. I stayed up all night because I was afraid that it would get worse, At about 9:30a.m. it seemed to be getting back to normal with just a little swelling in the back of my tongue. I felt terrible for the next three days and still don't feel great. Sore joints, got chills, headache. I am not going in for the second shot.
63 2021-02-10 feeling abnormal 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 2021-02-10 insomnia soreness at injection site (3 days), insomnia (1 night), headache (next day), body aches (next day)
63 2021-02-11 impaired work ability I began having headache, joint pain and muscle soreness throught my body about 5 hrs after vaccinati... Read more
I began having headache, joint pain and muscle soreness throught my body about 5 hrs after vaccination. When I got home from work around 5:00PM, I began having chills and shivering badly.
63 2021-02-15 impaired work ability Body pain, joint pain, exhaustion for 3 days, sensitive to light, painful skin similiar to sunburn, ... Read more
Body pain, joint pain, exhaustion for 3 days, sensitive to light, painful skin similiar to sunburn, low appetite, fever of 100; Treatment-Tylenol and rest for 3 days. Missed work
63 2021-02-15 nervousness, anxiety 1000; patient reports that she feels hot and states "I don't feel well but I can't describe it." BP... Read more
1000; patient reports that she feels hot and states "I don't feel well but I can't describe it." BP 106/63, HR 69, SpO2 99% 1003; Patient is diaphoretic appears anxious. Paitnet reports that she feels clammy, shaky, nauseous. BP 107/67, HR 62, Spo2 98% 1006; Nausea subsided. remains diaphoretic, but not pale. BP 118/74, HR 62, SpO2 98% 10:18; Patients states "I feel better, I'm not hot or shaky anymore." She sat up on the side of the bed. BP 114/76, HR 75, SpO2 98% 10:27; Patient states, " I don't feel good again" and laid back down. She reported that she feels hot again. BP 105/72, HR 80, Spo2 99% 10:34; Pt states "Ok I'm want to try and sit up again." 10:36 Patient states, "Ok, I'm doing good." BP 135/81, HR 82, SpO2 99%. 10:38 Patient states" I do feel much better." No evidence of diaphoresis, anxiety, tremors. BP 128/78, HR 82, pt ambulates steady to private vehicle
63 2021-02-15 sensation of foreign body Felt like I had a lump in my throat 45 minutes after shot, then 2 hours later patch of Hives broke o... Read more
Felt like I had a lump in my throat 45 minutes after shot, then 2 hours later patch of Hives broke out on left thigh
63 2021-02-17 anxiety 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 2021-02-17 sleep disorder Had chills during the night after 2nd shot, enough to wake me, gone in morning.
63 2021-02-18 impaired work ability I had the Vaccine on 1/25/21, in my Right Arm. I started having symptoms on 1/26/21, I worked half ... Read more
I had the Vaccine on 1/25/21, in my Right Arm. I started having symptoms on 1/26/21, I worked half a day and went home with Chills, Joint pain, Headache and missed work on 1/27. I had joint pain in my fingers and toes, but continued to work, I tried Tylenol with the pain, On 2/3/21 while at work I got the COVID Arm symptoms, Hot arm, Red rash, Huge hard knot, ( I put an Ice pack on the site while at work and took Tylenol) I also have had more joint pain in my Fingers and Toes causing me to stay home from work on 1/4 and 1/5 and again on 1/8 and 1/9. The Burning and Sharp pain in my fingers, toes (swelling in my toes on my Right foot) and wrist have not gone away. I have been woken up from the Sharp pain in my fingers and toes, it is uncomfortable wearing shoes. I still have the COVID Arm, the red rash the Hot and the swelling of my arm, the heat comes and goes in my arm, the red rash has been continuous since it first appeared, the knot has shrunk in size.
63 2021-02-21 feeling abnormal 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 2021-02-24 impaired work ability 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 impaired work ability The patient had swelling and erythema to the arm 1 hour after dose with blotchy skin and itching. T... Read more
The patient had swelling and erythema to the arm 1 hour after dose with blotchy skin and itching. This has progressed to severe headache and gastric distress along with fatigue to the point that she can not stay up for only 2 hours at a time. The fatigue is the largest symptoms. She is not able to carry out her job at this point. The symptoms have not been relieved with Tylenol. This has continued for 5 days.
63 2021-02-25 nervousness Nausea, severe back pain, chills, weekness, nervousness
63 2021-02-28 anxiety Vaccine administered, 10 minutes later pt stated she felt dizzy. She did mention she was anxious aft... Read more
Vaccine administered, 10 minutes later pt stated she felt dizzy. She did mention she was anxious after reading possible side effects of COVID vaccine. She started to cry and mentioned the recent loss of a family member. Five minutes later, stated she felt nauseous. Pt crying and requesting for us to call her sister. Denied chest pain, tightness of chest or trouble swallowing. Denied shortness of breath,
63 2021-02-28 incoherent fever overnight, barely coherent, lethargic, severe joint and muscle pain, headache, vomiting, no ap... Read more
fever overnight, barely coherent, lethargic, severe joint and muscle pain, headache, vomiting, no appetite, had covid in October
63 2021-03-01 feeling abnormal Fever of 103. Chills and severe body aches; headache; exhaustion and fatigue. I had brain fogginess ... Read more
Fever of 103. Chills and severe body aches; headache; exhaustion and fatigue. I had brain fogginess - brain was disconnected from thought process. That all lasted from Wednesday-Sunday. It got a little better each day (Wednesday and Thursday were really bad.) I took aspirin - it helped relieve the headache.
63 2021-03-01 impaired work ability Moderna COVID-19 Vaccine EUA, My legs were getting sore and tired at work. I sat down to tie my... Read more
Moderna COVID-19 Vaccine EUA, My legs were getting sore and tired at work. I sat down to tie my shoe and noted Pitting + 3 or 4 edema to BIL Calves. Redness , warmth in a few areas. R leg 1" larger than L. Then I mentioned it to another nurse and she said it could be side affect of Norvasc. I spoke with my PA about it on 2/12 she D'C'd Norvasc and perscribed Nefidepine 30 mg ER. I have not taken it yet I am monitoring my BP and it is WNL. The edema less in calves however continues in ankles. I have gotten MULTIPLE broken capillaries all over my legs. Long short it has to be a reaction to vaccine. And it continues almost 2 months after injection. I can't wear most of my socks. It is BAD.
63 2021-03-02 feeling abnormal 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 2021-03-02 feeling abnormal 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 nervousness 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 sleep disorder Woke up in middle of night with burning and itching on elbow in right arm, same arm as vaccine. Ther... Read more
Woke up in middle of night with burning and itching on elbow in right arm, same arm as vaccine. There were bumps resembling insect bites or poison ivy on elbow and red area, Botches of red spread up right arm to head, causing itchiness. Next day, the blotches were gone, but the redness and bumps on elbow remained. Two days later, the bumps, itchines and redness remain on the elbow, and some bruising has appeared. The shot was administered in the upper right arm. Not sure if this attributable to the vaccine, but there's nothing else that has changed.
63 2021-03-03 feeling abnormal, anxiety, restlessness 3/4/21 1005am pt started complaining of feeling flush, restless, and anxious. pt states that she do... Read more
3/4/21 1005am pt started complaining of feeling flush, restless, and anxious. pt states that she does not feel right and that there is something wrong. then pt reported that her legs felt numb.First RN and Second, RN was present to assist pt. pt was put on 4L of O2 by mask. Dr was called to assist. pt was moved from sitting in chair to laying on floor with legs elevated. pt reporting that her hands and legs were feeling numb. per Dr pts lungs were clear with good air exchange. pt alert and oriented to self, place, and time. 1012am BP 141/81 P 71 SaO2- 100% BS 99 pt still feeling flush and restless with anxiousness increasing. upper lip swelling. questionable tongue swelling. hand and feet numbness. pt states does not feel right. V.O. Dr 25mg Benadryl IM now administered to the right deltoid IM, RN 1020am BP- 162/100 P- 72 SaO2- 100% pt still feeling flush and restless with anxiousness. still with some upper lip swelling. questionable tongue swelling. hand and feet numbness is still reported. pt states she still does not feel right. husband is now with pt at her side and trying to calm her. pt is c/o some SOB, per Dr pts lungs are still clear. pt remained alert to self, time, and place. V.O. Dr. Albuterol neb treatment now attempted to start neb treatment however pt was not tolerating neb. ok by Dr to stop neb treatment. 1025am called AMR V.O. Dr 1mg Epinephrine now administered 1mg Epinephrine IM right deltoid. P. , RN 1027am pt wanting to sit up. states cannot get comfortable laying down. assisted pt to sit up. pt is less anxious. reports to feel less restless. decrease upper lip swelling and tongue swelling. pt reports that she is starting to feel a little better. pt is feeling less numbness in hands and feet. BP-141/58 P-99 SaO2-100% 1037am pt starting to complain of feeling flush, restless, and anxious again pt states that she does not feel right and that there is something wrong again. pt again reporting that her hands and feet felt numb. per Dr - pts lungs still clear with good air exchange. pt remains alert to self, place, and time. per Dr draw up another dose of Epi while waiting for AMR, AMR arrived prior to drawing up second dose of Epi. 1039am AMR arrived. transferd pt from floor to gurney and trnsported pt to ER. ................................................................... RN March 4, 2021 3:20 PM
63 2021-03-04 insomnia, sleep disorder Headache and Bad upper arm/shoulder pain the first night and second day. Severe upper arm/shoulder ... Read more
Headache and Bad upper arm/shoulder pain the first night and second day. Severe upper arm/shoulder pain - so bad that it kept me up at night and I couldn't lay on my left side. Along with the shoulder pain the second night the headache continued on and off (took aspirin to try to help) the second day and through the night and a low grade fever 99.5-100. developed through the second night.
63 2021-03-06 feeling abnormal Brain fog next day, loss of taste and smell48 hours post vax lasted 18 hours
63 2021-03-08 anxiety I developed mild h/a, nausea, & sore arm day of injection- h/a & sore arm resolved in 48 hrs. Mild, ... Read more
I developed mild h/a, nausea, & sore arm day of injection- h/a & sore arm resolved in 48 hrs. Mild, intermittent nausea has cont x13 days now, no vomiting. Also noted (day after jab) difficulty starting urine & mild pain in bladder area on urination for several days afterward. Increased anxiety, possibly b/c Moderna has refused to advise me on this reaction x3 calls now. I am not likely to take vax2, b/c now I am concerned this may be permanent and I refuse to make it any worse that it already is. I need to know if I can try the J&J vax, and if so, when should I get it?
63 2021-03-08 excessive sleepiness 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 2021-03-09 feeling abnormal Felt fine for first 36 hours, then the typical "viral prodrome" feelings of fuzziness with a low gra... Read more
Felt fine for first 36 hours, then the typical "viral prodrome" feelings of fuzziness with a low grade temp of 99.9 and generalized malaise overnight. Felt fine on day 3 post-injection. Starting that evening of 3/5/21 I noted sharp pains of phyarngitis (like Strep), but ONLY on the RIGHT side. When I woke the next morning, very painful to swallow, very tender nodes only in the Right neck that were somewhat enlarged. The pain was strictly located to the RIGHT side of my neck and throat. No axillary nodes or tenderness. Today my symptoms persist - I find that I wake up after 4 hours of lying supine due to soreness in Right neck and increased fullness in soft tissues.
63 2021-03-09 feeling abnormal Patient called via telephone at 4:53 p.m. on 2/26/2021. Patient reports that she was in for a 3:40 C... Read more
Patient called via telephone at 4:53 p.m. on 2/26/2021. Patient reports that she was in for a 3:40 Covid-19 (Moderna) 1st dose shot appt. She waited her allotted 15 minutes post vaccine before leaving. Patient denied ever having any reaction to anything or vaccine in the past. Patient reports that once she was on her way home she started to experience nausea while driving home. She also started to experience a weird kind of numb feeling that in time moved down in to her left arm, up her to the left side of her neck, jaw and eye. She felt like her eyelid might be drooping but she looked in the mirror and it wasn't. She explained it as a "novacaine feeling" before it is fully numb. "It starts in a spot then spread." "Weird sensation, like going to the dentist. Patient reported that she also has "weird skin" on her arm so can't really tell if there is a local rash. Patient questioned if she can take Bendedryl and this PHN confirms that she can do that. PHN confirms that patient is not home alone and encouraged patient to follow up if she felt the need if her symptoms did not resolve or continue to spread or worsen. Patient reports understanding of this. 1/26/2021: 6:30 p.m. call update from patient. This PHN called patient back and patient reports that she is lying low. She took some Bendryl and it helped some. Patient continues to have a little bit of numbness and it did go in to her left teeth a little bit but the numb feeling isn't as bad as it was. PHN recommended that patient try to verify with her doctor before dose 2 of what happened and verify that it is okay to get her 2nd dose. PHN also informs patient that the is diphenhydramine ("Benedryl") on site that we can give her if needed when she is here for her 2nd dose. PHN also recommends that if she comes in for her 2nd dose she would wait for 30 minutes post vaccination vs. the typical 15 minutes. 3/9/2021 telephone update from patient. Patient contacted this PHN to inform that she has had continued issues post Covid-19 vaccination. Patient reports that she continues to have some numbness in the left side of her face and her BP continues to fluctuate up and down ranging from 182-90 to 142/?. She has been in to doctor 2 times and has 1 more appointment scheduled. She also is considering doing a neuro consult. She did have testing done that ruled out a stroke. Patient is unsure if she wants to follow through with her 2nd. PHN did not recommend patient getting her 2nd dose but encouraged her to have this discussion with her primary care provider
63 2021-03-10 impaired work ability Malaise, HA, body aches, fever, missed next shift
63 2021-03-10 sensation of foreign body 102 Fever, Sweats, Chills, all joints on fire and in pain, headache, nausea, swollen lymph nodes in ... Read more
102 Fever, Sweats, Chills, all joints on fire and in pain, headache, nausea, swollen lymph nodes in neck. Took several days to feel better. After I felt better I ate shrimp on 2-13 and 2-17 and had a reaction to the shrimp on 2-17 which required a doctor visit and complete bloodwork analysis which showed allergy to shrimp and a high titer which could be an auto immune disorder. Since then I have logged foods and have determined I have reactions when something has MSG or Maltodextrin. I have dry back of my throat, a feeling that I have a lump in my throat, eyes seem a little dry, the headache has not gone away. Pressure on the top of my head and my forehead. Tingling and on fire in hands wrists, forearms, shins and ankles. I have an appointment with a Rheumatologist on March 30.
63 2021-03-10 sleep disorder, anxiety, nervousness Modern Vaccine I felt a little nervous but I?m not afraid of vaccines. Arm hurt, got home was more s... Read more
Modern Vaccine I felt a little nervous but I?m not afraid of vaccines. Arm hurt, got home was more shaken inside. Took Ibprophen for pain. I continued to feel hyper, then tired, repeatedly all day long. At some point I remember feeling like my breathing was way too fast. The nervousness became fretfulness. At bedtime, I took my normal medicine and 3 mg of Melatonin as usual. I could not stay rested. My body would do one jerk and wake me. I finally got up to read and took .025 mg of Clazonapem . I have that for flying, etc. Today, March 11, 2021 I awoke at 6:30 am feeling much better but then as the day has continued I am out of sorts. Everything is very difficult to think about doing. My brain is getting stopped from simple writing ABC?s on index cards. Questions are overwhelming me. I?m not sure if I should even consider the second vaccine. This is very unsettling as I am normally very functioning as a teacher, artist, homemaker. Caring on a conversation is troubling.
63 2021-03-11 restlessness nausea, headache, fever, restlessness, passing out feeling, itchy,rash, ,
63 2021-03-12 insomnia Headache Chest pains/gas pains Leg cramps Foot cramps Flank pain Exhaustion Insomnia
63 2021-03-12 loss of personal independence in daily activities, excessive sleepiness I received the second vaccine injection at approximately 1:15 pm on 3/9/2021. At 8 o?clock pm of tha... Read more
I received the second vaccine injection at approximately 1:15 pm on 3/9/2021. At 8 o?clock pm of that same day I started having severe chills. At 10 o?clock pm on that same day I had a fever of 101 Fahrenheit. That fever of 101 lasted for 31 hours. In addition to the fever, I had severe chills, severe body aches, and injection site reaction of swelling and throbbing pain. I was on able to perform normal daily duties and was unable to get out of bed for more than using the toilet. I was also exhausted and slept for the majority of the 31 hours whilst having the fever. I was unable to function normally until mid afternoon on 3/11/2021. Truthfully, this was an horrific experience.
63 2021-03-14 disturbance in attention Around 12 noon, approximately 20 hours after receiving second dose of Moderna Covid 19 vaccine I sta... Read more
Around 12 noon, approximately 20 hours after receiving second dose of Moderna Covid 19 vaccine I started feeling lightheaded, was unable to concentrate and felt like I was going to pass out, leg muscles became achy and rubbery feeling. Sat down and put my head down to avoid collapsing. Sat for about 15 minutes like this and became very warm and began sweating profusely. Felt nauseous and had dry heaves. Stood up and put my head down on our sink. (I was at work at the time as a retail pharmacist) Stayed in this position about another 10 minutes. Finally my head felt like it was starting to clear so I stood up and was able to walk around the department. Went back to my workstation and was able to concentrate but then felt very chilled to the point where I started shaking. This lasted about 20 minutes. Shaking gradually stopped but then I felt very tired. Was able to finish my shift 2 hours later, was able to drive home but felt very tired and was having muscle pain in my lower legs (thighs to ankles) and developed a mild headache. Took one Aleve (naproxen sodium) tablet around 4pm that afternoon. Started feeling somewhat "normal" later in the evening around 8pm. Woke up Sunday 3/14/21 and felt fine.
63 2021-03-14 feeling abnormal The same night after getting my second dose, I woke up about 3:00 AM to go to the bathroom. I could... Read more
The same night after getting my second dose, I woke up about 3:00 AM to go to the bathroom. I couldn?t sit up. So I slid down to the floor and tried to get up using my arms to push myself up but I couldn?t. It was like I was paralyzed. I had to call to my husband who was in another room to pick me up. I wet myself. Had absolutely no control. He literally had to pick me up amd practically carry me to bathroom using his legs and kinda dragging me. No leg muscles working and arms barely. Then he had to pick me up off toilet and drag me back to bed using his legs. I took a Tylenol and went back to bed and in the morning muscles worked and I could walk again. So I never did call the dr because side effect went away but thought I should report it to you because I never heard of this happening. Second day (yesterday) I was just tired and kinda weak and not very hungry, little nauseous but today, knock wood, seem back to normal.
63 2021-03-14 sensation of foreign body shortly after receiving vaccine patient stated she felt like her throat was tight and there was some... Read more
shortly after receiving vaccine patient stated she felt like her throat was tight and there was something in it
63 2021-03-15 sleep disorder about 30 minutes later tingley on left side of face. next morning arm felt sore. went to work stomac... Read more
about 30 minutes later tingley on left side of face. next morning arm felt sore. went to work stomach hurt. didnt eat. left work early had chills and could not get warm. when i got home had diarea. had diarea for three days. Bad headache. went to bed and could not sleep. Finally fell asleep. really weak for a couple of days. also legs were very painful. I have pain in my legs some times. but this was really intense,put hot and cold to help. really tired wanted to sleep.
63 2021-03-17 feeling abnormal Dizziness, Headache, Diarrhea, Nausea Vomiting, FOGGINESS, BURNING IN ARM
63 2021-03-17 nervousness 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 2021-03-19 anxiety 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 2021-03-19 sleep disorder hours after the vaccine was given I started to experience tiredness throughout my whole body. I wen... Read more
hours after the vaccine was given I started to experience tiredness throughout my whole body. I went to sleep ususal time, slept poorly tossing and turning, then spent the entire next day in bed. I was lethargic and was zapped of any energy.
63 2021-03-20 feeling abnormal 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 insomnia Chills, headache, painful arm, couldn?t sleep
63 2021-03-21 sleep disorder 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 2021-03-22 feeling abnormal, excessive sleepiness When leaving after first shot, extreme nausea, chills ran a fever about 100 degrees through all reac... Read more
When leaving after first shot, extreme nausea, chills ran a fever about 100 degrees through all reaction, fatigue. headache, muscle pain did not vomit. Did have brain fog, made dinner and have recollection of doing it, went to wash dishes and I had already done them, sick for three days, sleep almost 24 hours
63 2021-03-23 confusional state 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 2021-03-23 feeling abnormal VERY painful arm - pain started 5 hours after shot, increased for 24 hours, then decreased over 24 m... Read more
VERY painful arm - pain started 5 hours after shot, increased for 24 hours, then decreased over 24 more hours. Bad for 48 hours total. Felt like somebody hit it with an iron bar. Could not move it, it would not support weight. Mildly sore for 24 more hours. No redness or swelling or hardness. Swollen glands - 48 hours Slightly dizzy at intervals for 48 hours + brain fog for 3 more days Achiness in joints, especially legs
63 2021-03-23 feeling abnormal First noticed 9 am 3/24/21 the pupils of both eyes are constricted, and have remained so to 5 pm. A... Read more
First noticed 9 am 3/24/21 the pupils of both eyes are constricted, and have remained so to 5 pm. Approaching 24 hrs since dose 1 vaccination, pupils have not changed. Injection site somewhat sore, fuzzy headed feeling seems to be diminishing. No other symptoms at this time.
63 2021-03-23 impaired work ability, disorientation 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 sleep disorder Received injection and feels that the injection was given too high on the shoulder. Severe pain on l... Read more
Received injection and feels that the injection was given too high on the shoulder. Severe pain on left shoulder so that she could not mover or lift her arm. She conducted a virtual visit but was still having no relief and went to Urgent Care on Monday March, 22nd. They did x-rays and prescribed Naproxen. She can not sleep or find comfort.
63 2021-03-24 abnormal dreams I became very achy, had a headache and fever of 102.4. I had ear aches and was hearing a pounding in... Read more
I became very achy, had a headache and fever of 102.4. I had ear aches and was hearing a pounding in my ears for 3 days. I was still experiencing symptoms on Thursday after being dosed on Monday. I had vivid dreams on Wednesday night that were very detailed. Thursday I began to have GI effects with nausea and diarrhea. I was not able to eat until late Wednesday evening. I did drink water and took Tylenol.
63 2021-03-24 confusional state Seizure; Neurologically confused; A spontaneous report was received from a consumer concerning a 63-... Read more
Seizure; Neurologically confused; A spontaneous report was received from a consumer concerning a 63-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a seizure and was neurologically confused (confusional state). The patient's current conditions included epilepsy. Concomitant product use was not provided by the reporter. On 26-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 22-FEB-2021, right before the patient was supposed to get the second dose of vaccine, she had a seizure and was hospitalized. The same day, patient was neurologically confused. The patient underwent different unknown tests including computerized tomography. On 24-FEB-2021, the patient was discharged from hospital. No treatment information was provided by the reporter. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, seizure and confusional state were resolved/recovered; Reporter's Comments: Based on reporter's causality and the prior history of epilepsy, the events are assessed as unlikely related to mRNA-1273.
63 2021-03-24 feeling abnormal pt stated that her left arm is red, warm and swollen about the size of a baseball at the injection s... Read more
pt stated that her left arm is red, warm and swollen about the size of a baseball at the injection site. Pt had a fever, temp was 100.6. She has body aches, headache, lightheadedness, has fatigue and her mind is foggy. she has taken ibuprofen. Pt will contact PCP if her symptoms get worse.
63 2021-03-24 feeling abnormal APPROXIMATELY 25 MINUTES AFTER FIRST DOSE MODERNA PATIENT COMPLAINED OF "ITCHING TO LEFT SIDE OF NEC... Read more
APPROXIMATELY 25 MINUTES AFTER FIRST DOSE MODERNA PATIENT COMPLAINED OF "ITCHING TO LEFT SIDE OF NECK/SHOULDER THEN LIPS ITCHING, THROAT NUMBNESS AND WORSENING OF ITCHING TO LIPS AND "FEELING REALLY WEIRD". SHE WAS TREATED ON SITE WITH 0.5MG EPI IM X 3 AND BENADRYL 50 MG IM X 1 THEN WAS TRANSPORTED BY EMS TO THE ER. SHE WAS EVALUATED AND RELEASED WHEN CLINIC CALLED TO CHECK ON HER LATER IN THE AFTERNOON
63 2021-03-25 disturbance in attention On 11 Mar 2021 at 11:00 am (23.5 hours post vaccine) I had a mild headache and significant dizziness... Read more
On 11 Mar 2021 at 11:00 am (23.5 hours post vaccine) I had a mild headache and significant dizziness. I had to leave my work desk. This lasted for approximately 2 hours and then "lifted" and I went back to work. At 4:00pm, about 5 hours later (28.5 hours post vaccine) I felt a total lack of concentration, extreme fatigue, and dizziness. I should have left my desk but had work I needed to complete. This episode also lasted for about 2 hours and then I felt pretty normal again. The following day, on 12 Mar 2021, at 5:00 pm (53.5 hours post vaccine) I had what I described to my sister as crazy dizziness and extreme lethargy. This lasted for 2-3 hours, I was able to go out with my husband to a store, but was not able to drive. I also experience two days where I had a metallic taste in my mouth. It was not overwhelming, and since I'm sensitive to odors and chemicals anyway I just assumed that there was something in my home I was exposed to, even though that had never happened to me before in my home. This probably occurred on day 3 & 4 post vaccine (13 Mar 2021 and 14 Mar 2021) but I did not annotate the details. I am very suspicious this was also related to the vaccine. As I think about my past few days, especially while at work, I think I am having a harder time than normal concentrating, although at times I have perfect clarity and feel normal.
63 2021-03-25 excessive sleepiness Initially, I was fine. That evening, I started to feel tired, achy and feverish. MY belly also hurt.... Read more
Initially, I was fine. That evening, I started to feel tired, achy and feverish. MY belly also hurt. I felt really bad by the morning, so I took some Ibuprofen. The belly pain was in my left abdomen, which is the area where the pain was when I experienced diverticulitis four years ago. I decided to drink liquids and not eat a lot. I slept off and on all day. On Wednesday, I was still feeling badly, so I started antibiotics. I started to throw up that evening, so I went to the ER. I got some IV fluids and a lot of testing. I was still nauseous for a few days and I eventually got back to normal. I got the 2nd dose and all I experienced was a sore arm and a little fatigue.
63 2021-03-25 insomnia difficulty sleeping, headache, muscular/joint aches
63 2021-03-25 nervousness Tingling on tongue pressure to face weakness to bilateral legs was nervous due to multiple health is... Read more
Tingling on tongue pressure to face weakness to bilateral legs was nervous due to multiple health issues cleared by NP
63 2021-03-25 sleep disorder I first experienced some nausea immediately after receiving the vaccine, but it went away after I at... Read more
I first experienced some nausea immediately after receiving the vaccine, but it went away after I ate something after my vaccination. I then experienced pain at the injection site a couple of hours after receiving the injection. Around 10 p m,,. I started having episodes of waking up and having too throw up phlegm. The next day I had a lot of sinus pain and a headache. My left arm continued to hurt, and I noticed I couldn't lift it sideways all the way to my head. At my shoulder, it would want to turn towards my body. Most of the pain has subsided, but I still am having difficulty lifting my arn,
63 2021-03-26 nervousness within a couple hours of the shot I felt a nervous feeling inside. this continued to grow in me a co... Read more
within a couple hours of the shot I felt a nervous feeling inside. this continued to grow in me a couple of days along with an increasing headache. I started breaking out in a rash mostly on my head, around my right eye, chest and back, on about the third or forth day. I also developed diarrhea. I went to Urgent care on 03/17/21. the doctor there gave me a shot of prednisone and things quickly cleared up.
63 2021-03-28 loss of personal independence in daily activities 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 2021-03-29 feeling abnormal Patient reported that she had experienced fever, headache, joint pain, pain and redness and injectio... Read more
Patient reported that she had experienced fever, headache, joint pain, pain and redness and injection site along with feeling "foggy" shortly after receiving the first Moderna vaccine dose. These symptoms lasted for 5 days.
63 2021-03-29 insomnia, loss of personal independence in daily activities PT IS ON 4TH WEEK OF XELJANZ. SHE HAD HER 1ST MODERNA COVID VACCINE 12 DAYS AGO. PT STATES THAT EVER... Read more
PT IS ON 4TH WEEK OF XELJANZ. SHE HAD HER 1ST MODERNA COVID VACCINE 12 DAYS AGO. PT STATES THAT EVERY JOINT IN BODY ACHES. THE SEVERE PAIN SEEMS TO ROTATE AROUND JOINTS - CURRENTLY HER RIGHT HAND IS WEAK & PAINFUL THAT SHE CAN'T PICK UP OBJECTS. HER RIGHT SHOULDER/ELBOW, WHOLE ARM IS SEVERE PAIN. SHE HAS HEADACHES. SHE IS EXHAUSTED & GOES TO BED ABOUT 7:30PM. IT'S HARD TO FALL ASLEEP & THEN HARD TO GET OUT OF BED SINCE SHE CAN'T LIFT HERSELF UP (HAS TO ROLL OUT OF BED). SHE IS A GOLFER & TRIED TO GOLF THE OTHER WEEK. SHE TOOK 2 ALEVE AT START & BY THE BACK 9 HOLES HAD TO TAKE AT LEAST 2 MORE. SHE IS TAKING ABOUT 6 ALEVE TABLETS IN A 12 HOUR PERIOD RIGHT NOW TO HELP ALLEVIATE THE PAIN. SHE STATES SHE WAS NEVER IN THIS SEVERE PAIN BEFORE XELJANZ OR COVID VACCINE. PT CAN'T PINPOINT WHEN THE SEVERE PAIN STARTED - PRIOR TO OR AFTER COVID VACCINE. PROVIDED CONSULTATION AND ADVISED PT TO F/U WITH MD TOMORROW MORNING.
63 2021-03-30 feeling abnormal, hallucination I WOKE AT 5AM THE MORNING AFTER MY INJECTION AND I WAS SOAKING WET IN SWEAT AND HAVING CHILLS. I C... Read more
I WOKE AT 5AM THE MORNING AFTER MY INJECTION AND I WAS SOAKING WET IN SWEAT AND HAVING CHILLS. I COULD NOT MOVE MY BODY OR SPEAK. MY THROAT/MOUTH WAS SO DRY I COULD NOT OPEN MY MOUTH. I THOUGHT I WAS HAVING A STROKE. I LAID THERE NOT MOVING AND EVERYTHING WAS HAZZY. IT WAS LIKE I WAS FLOATING ABOVE MY BODY. AFTER ABOUT 3O MINUTES I COULD ROLL OVER BUT STILL COUD NOT MOVE MY LEGS OR ARMS. AFTER LAYING THERE ANOTHER HALF HOUR I FINALLY COULD SIT UP BUT SILL NOT STAND. I SAT ON SIDE OF BED HAVING SEVERE CHILLS AND HALUCINATIONS. EVERYTHING WAS STILL HAZZY AND FOGGY. FINALLY I WAS ABLE TO STAND AND WALK A FEW STEPS TO BATHROOM WHERE I SAT FOR A GOOD HALF HOUR BEFORE BEING ABLE TO WALK TO MY LIVING ROOM TO SIT IN RECLINER. I COULD NOT QUINCH MY THRIST AND KEPT DRINKING LOTS OF WATER ALL DAY. I STILL HAD CHILLS FOR ABOUT 7 HOURS. I WAS SO WEAK THAT NEXT DAY AND IT WAS NOT UNTIL THE FOLLOWING DAY THAT I WAS KINDA BACK TO MY NORMAL SELF.
63 2021-03-30 feeling abnormal 3/18/2021 extreme fatigue,worsening joint pain, waves of heat and nausea,hacking dry cough,extreme r... Read more
3/18/2021 extreme fatigue,worsening joint pain, waves of heat and nausea,hacking dry cough,extreme runny nose,headache,brain fog, started on 3/18/2021 started to end 3/21/2021. 3/21/2021 red, blistering,itchy rash at injection site, lasted one week until 3/28/2021
63 2021-03-30 feeling abnormal Shortness of breath, tingling in both arms to chest area, felt faint, dizziness, weak 20 minutes aft... Read more
Shortness of breath, tingling in both arms to chest area, felt faint, dizziness, weak 20 minutes after the shot. Then for a week felt tired, head fog, headache, stomach bloating and diarrhea.
63 2021-03-31 confusional state Headache, chills, joint pain, over-all aches, eye sensitivity, local pain at injection site, thirst... Read more
Headache, chills, joint pain, over-all aches, eye sensitivity, local pain at injection site, thirst, fever of 101.9, slept for18 hours after onset of symptoms. The fever broke within 24 of onset. Headache remained and felt tired and somewhat confused for most of the next day. Then third day I was much better. On 4th day I had very bad diarrhea.
63 2021-03-31 loss of personal independence in daily activities At first just very tired then headache, vomitting, 102 temp, chills, entire spine very painful espec... Read more
At first just very tired then headache, vomitting, 102 temp, chills, entire spine very painful especially sacrum with pain radiating down both legs, burning at injection site but arm isn't sore, rash (small red dots over entire body), tips of toes and fingers bright red, This was yesterday and last night. Much better today with slight headache and rash. Headache and spine pain was very painful. Vomitted bile all night. I'd drink water and few minutes later get sick. Looked like antifreeze or bright Gatorade. I was too sick to call anyone. My friend came by and gave me a bucket and water. I dint have energy to get up much less go anywhere.
63 2021-03-31 sleep disorder 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 2021-03-31 sleep disorder Roughly 10 hours after injection: fever, chills, dizziness, freezing and on fire at the same time. F... Read more
Roughly 10 hours after injection: fever, chills, dizziness, freezing and on fire at the same time. Fully clothed in bed with hands too icy to touch together to get warm, very thirsty, but too cold and fatigued to get up. Body aches, joint aches, muscle aches, and SPLITTING HEADACHE. Symptoms slightly better at 4 a.m. , enough to get cup of water but only a couple sips would go down. Could not sit up to drink and it spilled all over sheets. No sleep yet at this point. Did not want to take any medication on an empty stomach and already slight nauseous at the thought of food. The only saving grace was not throwing up so far. By morning the chills had subsided but the fever of about 99 (my usual is 97 ish) stayed with me all the following day. Body aches, splitting head and neck aches, and slight fever stayed with me. Finally able to get a little food in and some electrolytes about 4pm next day and took some ibuprofen. Finally pain started to lift. Took 3 more ibuprofen before bedmate melatonin, and a Xanax and fell asleep. Today all is better except slight dizziness and a little fatigue. Possible dehydration effects. It was 24 hours of misery in slow motion!
63 2021-04-01 anxiety 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 feeling abnormal Patient received the first dose of the Moderna Covid19 vaccine and began to experience itching in he... Read more
Patient received the first dose of the Moderna Covid19 vaccine and began to experience itching in her left (vaccinated) arm minutes later. By the time she got home she reported itching over her entire body as well as rashes appearing on her face. She took Benadryl and the itching and rash improved. However, she was still itching the next day and described having a weird allergy feeling like "being in a fog".
63 2021-04-02 disturbance in attention Extremely tired feeling Not able to focus Pain in left shoulder as if someone punched me there real ... Read more
Extremely tired feeling Not able to focus Pain in left shoulder as if someone punched me there real hard Nausea Weak Took a full week to feel somewhat better
63 2021-04-02 restlessness Felt tired on the day after the vaccine, went to bed 3 hours early. Slept for 11 hours, a restless ... Read more
Felt tired on the day after the vaccine, went to bed 3 hours early. Slept for 11 hours, a restless sleep. Had low-grade fever waking up the next morning after 2nd dose Moderna vaccine. Fever last about 9 hours since then it was subsided gradually toward the end. Sore arm where vaccine was injected also the next day for the whole day. No redness nor swelling though at injection site. Did not feeling for 5-6 hours. No appetite for solid food. Went for chicken soup but felt nauseated eating chicken, but can tolerate vegis and noodles. Felt better around 4 pm the second day already.
63 2021-04-04 feeling abnormal I STARTED GETTING A BAD HEADACHE FRIDAY NIGHT AFTER RECEIVING MY SECOND VACCINE (MODERNA). ON SATUR... Read more
I STARTED GETTING A BAD HEADACHE FRIDAY NIGHT AFTER RECEIVING MY SECOND VACCINE (MODERNA). ON SATURDAY MORNING, I FELT AWFUL, HEADACHE, BODY ACHES, FEVER, CHILLS,SICK TO MY STOMACH. IT LASTED ALL DAY SATURDAY 4/3/2021. SUNDAY, I FELT A LITTLE BETTER, BUT VERY FATIGUED. ON SUNDAY NIGHT I NOTICED THE INJECTION SITE NOW HAS A RED RASH, IS SWOLLEN, ITCHY AND SORE. TODAY, MONDAY, STILL FEEL WEIRD AND VERY TIRED. INJECTION SITE ON LEFT ARM STILL SWOLLEN, RED, SORE AND ITCHY.
63 2021-04-04 insomnia, hallucination Insomnia and mild hallucination. Same evening as first dose only.
63 2021-04-04 restlessness Fatigue Restlessness Body aches Headache
63 2021-04-04 sleep disorder Developed intense itching/burning at and around the injection site, hive- like and localized to abou... Read more
Developed intense itching/burning at and around the injection site, hive- like and localized to about a 3 " diameter after 3 days. Kept me up all night, by next day was controllable with the topcial Benadryl that hadn't worked previously. Continued about a week, coming and going, but also felt like it was under the surface area. Has continued to flare up over the past several weeks, although the hives and redness went away and not as severe. The chills and extreme fatigue I experienced initially have continued all month- I am 4 days from my second dose and over the weekend experienced the worst fatigue of all- was out running and literally felt like I wasn't moving forward. I also suddenly developed joint and muscle pain with the recent extreme fatigue, especially back of neck. Occasional mild dizziness in the evening.
63 2021-04-06 disorientation 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 feeling abnormal 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 sensation of foreign body ON 04/01/2021 @ Vaccination drive through clinic safe room site - pt received 2nd dose Moderna vacci... Read more
ON 04/01/2021 @ Vaccination drive through clinic safe room site - pt received 2nd dose Moderna vaccine in Left deltoid. Approx 5 minutes after injection, pt reported "lump in throat" stated was same reaction as 1st dose which sulosided in 30 minutes. Pt assessed by nurse V/S 144/84, HR 62, P18, PT given Benadryl 25mg po pt stated she felt better. stated she was going home 5 min from site
63 2021-04-06 sleep disorder Extreme pain in upper arm, from neck down to wrist. Felt like aggravated nerve pain. Could not move ... Read more
Extreme pain in upper arm, from neck down to wrist. Felt like aggravated nerve pain. Could not move arm for 3 days due to pain. Could not sleep or function. This is 4th day and I still do not have full use of my arm. Fatigue
63 2021-04-08 anxiety 4/1/21: Per EMS on site, after COVID vaccine administration, client felt a rush of anxiety while in ... Read more
4/1/21: Per EMS on site, after COVID vaccine administration, client felt a rush of anxiety while in observation. After evaluation and observation for additional 15 minutes client felt better. Client signed Fire Department refusal and accepted all risks and responsibilities of refusal. Client walked out to her car to meet her husband.
63 2021-04-08 feeling abnormal Adverse Effects Tues 4/6: About mid afternoon felt deep chills and body aches, both of which lasted ... Read more
Adverse Effects Tues 4/6: About mid afternoon felt deep chills and body aches, both of which lasted until the next morning. About 4pm, felt an uncontrollable need to sleep; felt like someone conked me over the head and I was out like a light. Wed 4/7: Awakened still chilled and achy, but that eased by early afternoon. Fatigue continued; felt like I was moving through mud and fog. Thu 4/8: Felt better, but very slow, sluggish, a bit headachy. Mid-afternoon, I had trouble staying awake. I napped a bit. By bedtime, everything was gone; felt normal. Treatment I just wore warm clothes, covered myself in a blanket, drank water, rested, and slept when the urge hit. Didn't leave the house; only lazed about talking with my husband, watching tv (was too fatigued and weak to hold a book to read).
63 2021-04-08 feeling abnormal Arm soreness itching at injection site. Extreme tiredness and sleepiness. Brain fog flu like symptom... Read more
Arm soreness itching at injection site. Extreme tiredness and sleepiness. Brain fog flu like symptoms chills.
63 2021-04-09 excessive sleepiness, loss of personal independence in daily activities Swelling and hardening of large arge area of upper arm. Probably 5" in approximate diameter around i... Read more
Swelling and hardening of large arge area of upper arm. Probably 5" in approximate diameter around injection site, some itching about a week later, only generated by touching area. Soreness. Slowly reduced in size. Hard area about nickle size on 4/7/2021. And today about bb. Barely feel but area still has some soreness when touched. Not bad or bothersome, only if touched some slight sensitivity. While sleeping one night in first 48 hours, had a weird fairly painful sensation on inner left leg close to knee joint. It last about 15 minutes and was gone. I had never felt anything like that before. Brief moment of some discomfort in thighs, not really painful, just odd minor discomfort. Lasted about 4 hrs or so. Didn't keep me from doing anything. Nothing else. I do have a question whether I should get the 2nd dose in my other arm, instead of the one I hot the first shot in.
63 2021-04-09 insomnia I'm estimating that it was in the late afternoon the day after my vaccination, the tinnitus in both ... Read more
I'm estimating that it was in the late afternoon the day after my vaccination, the tinnitus in both ears became much louder, with the left ear particularly loud. It makes it difficult to sleep, even with a sound conditioner. On March 28, I sent a message to my primary physician, indicating the increased level of tinnitus and wondering if I should not take the 2nd dose in four weeks. He replied that tinnitus was not a side effect of the vaccine based on clinical trials and he would like me to get the 2nd dose. He said I could run it by an ENT. I saw an ENT, on April 8. She determined that I have minor hearing loss typical for my age and said that is likely the cause(cont.)
63 2021-04-09 loss of personal independence in daily activities low grade fever, headache, body aches, fatigue began 18 hours after vaccination. All symptoms were ... Read more
low grade fever, headache, body aches, fatigue began 18 hours after vaccination. All symptoms were mild but I was not able to do my regular things. Needed to nap and rest. Approximately 55 hours after vaccination majority of symptoms gone. Some fatigue is left over.
63 2021-04-09 sleep disorder Severe body aches, severe chills and headaches. Unable to sleep due to pain. Lasted all night and al... Read more
Severe body aches, severe chills and headaches. Unable to sleep due to pain. Lasted all night and all the following day. 3rd day less severe
63 2021-04-10 hallucination In addition to the usual, I hallucinated several times.
63 2021-04-10 panic attack, sleep disorder 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 sleep disorder 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 2021-04-11 feeling abnormal Around 8 o?clock the evening of my second Moderna vaccine I began to shake, felt like vomiting, my t... Read more
Around 8 o?clock the evening of my second Moderna vaccine I began to shake, felt like vomiting, my temperature went up to 101.9, my heart rate was 93 and my blood pressure was 150/93. Called Doctor after hours number and they told me to drink lots of water and take Tylenol. This lasted till the next morning when I was able to take a Tylenol and woke up with 100 degree fever. Kept taking Tylenol was able to eat a bit and couldn?t move that day. Still is experiencing diarrhea and weight loss Along with brain fog.
63 2021-04-11 loss of personal independence in daily activities Patient has a swollen ankle that has consistently bothered her. She could barely wear a shoe. The pa... Read more
Patient has a swollen ankle that has consistently bothered her. She could barely wear a shoe. The pain started right after the shot. She stated it is slowly getting better but has greatly affected her way of life. Patient also stated she went to the doctor and they stated that it was the vaccine that gave her the side effects.
63 2021-04-11 sleep disorder woke up in middle of night with extreme pain on right lower rib cage (front and back), no rash
63 2021-04-12 loss of personal independence in daily activities After vaccination, my mother stated that she had the normal symptoms, fatigue, headache, chills, sli... Read more
After vaccination, my mother stated that she had the normal symptoms, fatigue, headache, chills, slight fever for a day or two. After approximately 2 -3 weeks, she experienced severe headaches so debilitating that she was unable to get out of bed or perform daily functions. She had not fallen or performed any strenuous exercises that could have caused any severe headaches. She has never had a medical history of headaches or migraines. She has received her 2nd dose Moderna because at first, she did not associate the headaches with the COVID vaccine. Even after her second dose of Moderna, her headaches lingered. There are good days when she can go outside and take walks or enjoy her garden, but there are bad days when she can hardly get out of bed due to the headache. She is taking ibuprofen around the clock for the pain, and she?s awaiting approval from her doctor and insurance to get an MRI for more definitive diagnosis.
63 2021-04-13 anxiety - 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 anxiety Patient described feeling "funny" in face. Maybe, tingling or tight. No tightness in chest/throat o... Read more
Patient described feeling "funny" in face. Maybe, tingling or tight. No tightness in chest/throat or trouble breathing. Able to talk and eat up to 3 hours later. Patient was anxious about getting shot and thought it might be nerves. Had liquid Benadryl to take.
63 2021-04-13 feeling abnormal, impaired work ability Stayed under observation at Clinic for 15 minutes. Upon leaving started to feel dizzy but assumed ... Read more
Stayed under observation at Clinic for 15 minutes. Upon leaving started to feel dizzy but assumed it was just my nerves. Upon 20 minutes after shot my top lip started to tingle and went numb. Within 30 minutes extreme weakness and dizziness. Brain fog started within one hour. Fever, aches, and pain in arm within 24 hours. Covid arm and red neck within 36 hours. Stayed home for 3 days with gradual improvement each day. Fourth day fatigue and vertigo. Fifth day fatigue. Fatigue continued for one week
63 2021-04-13 feeling abnormal 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 panic attack 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 2021-04-15 sleep disorder Client states that she started feeling "electrical shocks" or "impulses" to her right cheek. She sai... Read more
Client states that she started feeling "electrical shocks" or "impulses" to her right cheek. She said she gets the feeling sporadically. The area is also painful to the touch and when she washes her face. She has also been awaken by the feeling. She went to an urgent care, and they did not see her., as they recommended that she report the episodes to the health department, first. This RN recommended she seek further evaluation, if not improving over the next couple of days.
63 2021-04-16 crying 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 2021-04-17 impaired work ability, loss of personal independence in daily activities 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 mental status changes Per patient's daughter, patient started with headache about an hour after her first Moderna COVID19 ... Read more
Per patient's daughter, patient started with headache about an hour after her first Moderna COVID19 vaccine. It turned into a migraine, and she started acting very weak. She was taken to the ER the next morning and presented with mental status changes, weakness, right arm tremor, neck/shoulder pain, and headache. Patient's symptoms were similar to when she had encephalopathy due to COVID in December 2020. She was transferred to the hospital on 3/12/21 for observation. Several tests were ran but nothing specific was found. The doctors overseeing her care felt she was experiencing a reaction to the COVID vaccine.
63 2021-04-19 depression, suicidal thoughts, anxiety Severe anxiety and depression, including suicidal thoughts
63 2021-04-19 disturbance in attention No adverse events following first dose on 3/19/2021 except soreness at injection site. The second d... Read more
No adverse events following first dose on 3/19/2021 except soreness at injection site. The second dose hit me hard the day after on 4/20/2021 when I woke up. I felt flat, difficult focusing, no energy, headache, really bad back pain , chills, and low grade avg . 100.4 fever. In bed for the night. Took Ibuprofen and using heating pad for back.
63 2021-04-19 sleep disorder *had mild arm soreness and stiffness at injection site in upper arm muscle for both vaccine series #... Read more
*had mild arm soreness and stiffness at injection site in upper arm muscle for both vaccine series #1 and #2. The arm soreness was present for several days after the vaccines, but diminishing. *had what I would describe as NOT an ongoing headache, but rather a few sharp shooting pains in head within first several hours of having Vaccine # 2. These only lasted a second or two each time although they re-occurred 3 or 4 times, and were tolerable. *had upset stomach with mild diarrhea the same evening after having vaccine#2, and later severe diarrhea again the next morning after having had vaccine#2 the prior day. The severe diarrhea bout iI described in the morning after vaccine # 2 was sudden and uncontrollable, which woke me up and caused me to soil myself before reaching the bathroom. There was no stool consistency whatsoever, very watery diarrhea.
63 2021-04-20 anxiety 1533: Patient notified staff of tingling in right shoulder at injection site and denied respiratory ... Read more
1533: Patient notified staff of tingling in right shoulder at injection site and denied respiratory problems, shortness of breath or swelling in the mouth. Upon further questioning patient stated she was anxious. Offered patient option to sit out front, monitored for the duration of her 30 min with mask off. 1536: Patient was still at chair and notified staff her tongue was beginning to feel thick. 1537: Patient brought to emergency area. Significant throat edema noted, uvula not visualized. Lung sounds clear to auscultation. 1542: 50mg Benadryl administered by RN, PA, RN. O2 administered via simple face mask at high flow 10L/min, 1550: 0.3mg Epinephrine administered IM by RN via Right vastus lateralis site. Patient's throat remained edematous, but uvula visualized and posterior pharynx visualized with patent airway after epinephrine. VS:1540: O2 sat 92, HR94, VS:1550: O2 sat: 98, HR 75 BP: 162/92, VS: 1555: O2 99%, HR 70, BP 162/88. Staff consult with Dr. He is aware of patient's status and advised EMS transport and approved patient treatment plan along with anaphylaxis algorithm. EMS Arrived 1557. Staff advised patient to go with EMS for transport to Emergency Room. After examination, EMS gave patient option to drive with husband. Patient elected to go with husband in their own car to ER. EMS transported patient in wheelchair to car with husband. Patient upon departure stated "my tongue has stopped feeling like it's swelling." No visible shortness of breath, ambulating well independently. A/O X3. Patient tolerated EPI well and was stable and calm through out time here. Husband was sitting next to her in emergency area also calm. Patient and husband stated she has not used her EPI pen in 10 years and probably used it about 10 years before that as well. She states she frequently takes 5-6 Benadryl 25 mg tabs for allergic reactions to bug bites.
63 2021-04-20 feeling abnormal Severe headache, fatigue, brain fog beginning 16hrs after injection, lasting approximately 48hrs. Tr... Read more
Severe headache, fatigue, brain fog beginning 16hrs after injection, lasting approximately 48hrs. Treated headache with Excedrin and ice pack. In and out of bed during time of symptoms. Injection site soreness lasting 72hrs (none following 1st vaccine)
63 2021-04-20 mental impairment symptoms started 03/23/21- fever 100.3 pounding severe headache and trouble searching for words when... Read more
symptoms started 03/23/21- fever 100.3 pounding severe headache and trouble searching for words when speaking. Also puzzle ability decreased previously patient could finish a puzzle in 3 to 4 days, now the same puzzle takes at least 7 days. There has been a progressive improvement after 10 days, still has delay.
63 2021-04-21 anxiety Immediately after receiving vaccine, patient felt light-headed and short of breath. After lying recu... Read more
Immediately after receiving vaccine, patient felt light-headed and short of breath. After lying recumbent for 5 minutes and then sitting up to drink water, the patient stated that she felt better. She was no longer dizzy. Patient stated that the shortness of breath she experienced was brief and that she has episodes of light-headedness and shortness of breath sometimes. Patient stated that she felt anxious and that she took all of her normal morning medications, but forgot her blood sugar med. Patient was monitored for 35 minutes then released to her ex-husband for a ride home.
63 2021-04-21 confusional state patient's spouse reported that patient was acting confused on 4/20, states usually happens when she ... Read more
patient's spouse reported that patient was acting confused on 4/20, states usually happens when she gets a UTI, CT chest/abdomen/pelvis concerning for urinary tract infection, patient admitted and currently admitted at the time of this report
63 2021-04-21 depressed mood, loss of personal independence in daily activities 24 hours after receiving the second injection was lethargic to the point of not being able to engage... Read more
24 hours after receiving the second injection was lethargic to the point of not being able to engage in every day activities. Symptoms lasted about 48+ hours more. Also experienced a depressed mood. All symptoms were gone by 4/19/21.
63 2021-04-21 feeling abnormal 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 loss of personal independence in daily activities Began Thur., 4/15/2021 --nausea,increased pain level, feeling ill, tired, weak. Began needing to nap... Read more
Began Thur., 4/15/2021 --nausea,increased pain level, feeling ill, tired, weak. Began needing to nap each afternoon lasting 2-3 hours. Not finding food that would sit on stomach. Vomiting probably every other day. Headaches that feel like the top of my head was going to blow off the rest of the head. This has been going on now for 8 days, with low grade fever over the past 3 days. Called Primary Care Dr to ask if this was me or reaction to injection--she said reaction to vaccine and to rest and take small amts to not add to nausea. Try to keep hydrated. Taking Acetaminophen for fever. Trying to rest. Not driving as do not feel safe to.
63 2021-04-21 memory impairment, confusional state 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 anxiety 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 feeling abnormal Sore arm, fatigue, chills, fuzzy in the head
63 2021-04-22 sleep disorder FIRST SHOT 03/17/2021 AWAKENED WITH CHAPPED LIPS AND SLIGHT PEELING. 2ND SHOT AWAKENED TO LIPS PEELI... Read more
FIRST SHOT 03/17/2021 AWAKENED WITH CHAPPED LIPS AND SLIGHT PEELING. 2ND SHOT AWAKENED TO LIPS PEELING LAYER AFTER LAYER OF SKIN BURNING , CRACKING BOTTOM LIP SWELLING VERY LARGE THEN DAY LATER TOP LIP SWELLING VERY UNCOMFORTABLE. IT HAS BEEN A WEEK AND i STILL HAVE ALL SYMPTOMS
63 2021-04-23 feeling abnormal 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 feeling abnormal Severe neck and headache. Started at shoulders and went to top of head. Lasted approximately 15 hr... Read more
Severe neck and headache. Started at shoulders and went to top of head. Lasted approximately 15 hrs. Hard to lift head. Experienced chills, sweats and nausea. Had muscle joint discomfort and all over body fatigue. Called Health Department and Dr. both said to take ibuprofen. I took the ibuprofen and headache and body ache subsided for several hours. When it started to come back I took ibuprofen again and the headache and body ache got better. The following day I felt foggy and dizzy.
63 2021-04-25 sleep disorder Since this shot I have constant ringing in my ears. My left arm where I had the second shot often ti... Read more
Since this shot I have constant ringing in my ears. My left arm where I had the second shot often times gives throbbing pain all the way down my arm and fingers especially at night that is usually the side I sleep on and I have been unable to to to this pain.
63 2021-04-26 feeling abnormal palpitations, fatigue, mental fogginess within 72 hours of second vaccine
63 2021-04-26 insomnia, loss of personal independence in daily activities I received the injection in my left hip. I got COVID arm again, but smaller and shorter duration th... Read more
I received the injection in my left hip. I got COVID arm again, but smaller and shorter duration than the 1st. Fever went over 104. I started taking Tylenol. The pain in my joints was excruciating this time. I couldn?t hold a coffee mug without using both hands. It was difficult to dress. Shoulders hurt so much I had trouble sleeping. All joints in hips, knees, ankles and feet hurt just as much. It felt like my ankles and feet were broken. I usually have a very high pain tolerance. It felt like after the Neulasta shots after my chemotherapy treatments. The bad part is I?m almost 5 weeks out and my fingers still feel broken . The other joints got better after 3 weeks. My finger joints are better, but it?s still painful.
63 2021-04-27 disturbance in attention Nausea, vomiting , dizziness when lying down and on the sides, dizziness when standing up, dizzines... Read more
Nausea, vomiting , dizziness when lying down and on the sides, dizziness when standing up, dizziness when bending over. Muscles aches and migraines. Feeling lightheaded continuously and unable to focus. Feeling tired and fatigued. This last most of the night. Nausea, vomiting , muscles aches and migraines stopped the next day but other described symptoms remained until Tuesday 04/27/2021. As of Wednesday 04/28/2021, lightheadedness and fatigue are still felt.
63 2021-04-27 sleep disorder No side effects with first shot except arm soreness. 2nd shot was brutal but I think I know why. I... Read more
No side effects with first shot except arm soreness. 2nd shot was brutal but I think I know why. I had severe severe muscle ache that Advil could not touch and I could not sleep. The next day I had the flu symptons (feverish, achy (not painful) muscles. I hate water. I truly believe the shot dehydrated me and caused the severe muscle pain. Now that I look back that had to be the problem. No one has ever described severe muscle pain as a side effect. Tell people to drink lots of water or gaterade and take two tylenol or ibuprophen. My husband did both and had not side effects other than a sore arm. The shots or at least the 2nd shots dehydrate some people. The next day around 6:30 pm all of my side effects disappeared and I felt great.
63 2021-04-28 sleep disorder Moderna COVID-19 Vaccine EUA. I had my 2nd vaccination around 5pm. in the evening. I woke up in th... Read more
Moderna COVID-19 Vaccine EUA. I had my 2nd vaccination around 5pm. in the evening. I woke up in the middle of the night and when I went to look at something with a small flashlight, the light hurt my eyes and I had to turn the flashlight off. I was unable to even focus on what I was trying to look at it was so bad and my eyes were so sensitive. Fortunately, that sensitivity did go away.
63 2021-04-28 sleep disorder Tuesday, 4/27, had extreme fatigue In the middle of the night, woke up ad she could not breath. Ev... Read more
Tuesday, 4/27, had extreme fatigue In the middle of the night, woke up ad she could not breath. Eventually went back to sleep 4/27 in afternoon, had another instance where could not breath, then sat up and felt better. Almost went to ED, but it resolved. Then 4/29, in AM, was taking grandchildren to school and started to feel squeezing both sides of lungs. When she takes a deep breath she has pain. She feels the pain is worsening and her SOB is worsening.
63 2021-04-29 anxiety 1ST dose: 3/2/21 5 pm headache sore left arm 4 days. benadryl/tylenol ok on 3/7/21. mild anxiety s... Read more
1ST dose: 3/2/21 5 pm headache sore left arm 4 days. benadryl/tylenol ok on 3/7/21. mild anxiety short of breath. general allergy. 2nd dose 3/30/21 : 4 PM 3/31/21: severe migraine -r hydroxyzine/tylenol hydrated ok. vitamins zinc, probiotics some cough - nose allergy seasonal. 5TH APRIL :itchy hands, arms, some pain on right hand. mild headache. 14TH APRIL 2021: woke up noon : severe headache, blurred vision, malaise, right hand frozen, pain, burning sensation upto upper right arm. itch. Cold pack treatment, numb pain on left finger tips. contact welts, red patches, hair nose eyes blurry dbl vision watery itchy - bitter taste in mouth. lower right leg toe nerve pain burn on toe. pinched nerves. upper arm.
63 2021-04-29 sleep disorder 4/28 started with extreme fatigue that evening, the next morning on 4/29 I had joint and muscle pain... Read more
4/28 started with extreme fatigue that evening, the next morning on 4/29 I had joint and muscle pain that got worse throughout the day. I had a sight headache and by afternoon I had a fever of 101 which lasted through most of the night. When I got awake at 2:00 am my arm was hurting from the injection site into my arm pit. Day 2 , 4/30 after the vaccine I'm still exhausted and achy but not as bad as the 1st day after.
63 2021-04-30 feeling abnormal 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 feeling abnormal, disturbance in attention 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 2021-05-03 feeling abnormal Global pain and inflammation so bad I cried. I have a high threshold for pain, having endured migrai... Read more
Global pain and inflammation so bad I cried. I have a high threshold for pain, having endured migraine with vomiting for decades. Felt like my skin was on fire. Fever 100.6 as compared to my normal 96 or 97. That was the initial 36 hours, which abated, but the aftermath is an exaggeration of my previously existing issues. Brain fog, being disoriented as to my body in space, catching half my body in a doorway, for instance. Profound fatigue. Just a hung over feeling in a non-drinker. Straight laced no drugs etc. person.
63 2021-05-04 delirium 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 panic attack, confusional state 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 loss of personal independence in daily activities 4/16/2021: Vertigo (30 sec.) when laying in bed ( 12:30 PM for about half hour) and occurred again ... Read more
4/16/2021: Vertigo (30 sec.) when laying in bed ( 12:30 PM for about half hour) and occurred again after I got up. Had not eaten prior and drank a lot of water after and no further incident occurred. I had taken an 1.5 hour walk in the morning. Fatigued 4/17/2021: Vertigo occurred during half hour yoga video session when I laid down on the mat. Approximately 30 seconds. Discontinued session and rested remainder of the day. No further events. Also drank 7 glasses of water with two cups of tea as I thought I was dehydrated. Fatigued remainder of the day. 4/18/2021: No vertigo but did not exercise and rested all day. Fatigued. 4/19/2021: Vertigo with yoga session twice in the morning. Approximately 15-30 seconds. Went to clinic to vaccinate residents and felt tired, but no further events. 4/20/2021: Vertigo occurred three times during yoga. Felt lightheaded after. Went to see primary health care provider at 1:30 PM in person and felt it was BPPV and provided at home instructions. Felt lightheaded in office when I stretched my neck to look up and when I got off of exam table. Vertigo occurred again when I went to lift my head to hang clothes on the line in the afternoon. No appetite. Hydrated again well and did eat. Fatigued remainder of the day. Nauseated in the evening and vomited due to vertigo. 4/21/2021 Vertigo severe in the morning and dry heaves after I woke up. Unable to attend vaccine clinic this day as I was so unbalanced I had difficulty ambulating. Just rested remainder of day. Could not perform exercises Dr. had suggested for BPPV . Fatigued. 4/22: Slightly improved through the day. Able to perform some of the exercises Dr. had suggested. 4/23/2021: Felt better. Vertigo lessoned throughout day 4/24.2021: Resolved. Vertigo lasted for one week.
63 2021-05-06 feeling abnormal, sleep disorder Seven hours later got violent shakes, very cold body, ice cube hands. Took ibuprofen went to bed, co... Read more
Seven hours later got violent shakes, very cold body, ice cube hands. Took ibuprofen went to bed, couple hours later shakes turned to small trembling. Middle of the night had severe headache around the crown of head /like it was put in a vise. Joint and body aches, fragile stomach, fever, off-balance. Stayed in bed for about 37 hours. Blew two big clots out of each nostril. Took about a week to feel ?normal? and not waking up with bad headache. The site of my injection and arm was never really sore. Almost went to ER . My first injection went well only had a slight metallic taste for a few hours and sore arm.
63 2021-05-07 fear Debilitating flare of Osteoarthritis. I was having very little problem with the Osteoarthritis in m... Read more
Debilitating flare of Osteoarthritis. I was having very little problem with the Osteoarthritis in my left knee, prior to vaccination. In fact, I had not had to take any pain pills in the five months previous. A few days after the second Moderna vaccination, my Osteoarthritis flared to unbearable pain in both knees and both hip sockets. I have been in pain ever since, and have to take two Extra Strength Excedrin every four hours to help alleviate the pain. I am unable to walk without a cane because my knees cannot support me without severe pain and fear of them collapsing.
63 2021-05-09 feeling abnormal pain and discomfort with sudden onset shingles outbreak(for the first time ever), patient suffering,... Read more
pain and discomfort with sudden onset shingles outbreak(for the first time ever), patient suffering, receiving treatment to date
63 2021-05-10 mental status changes No reported adverse reactions to first dose. Received second dose of Moderna COVID vaccine on 5/10/... Read more
No reported adverse reactions to first dose. Received second dose of Moderna COVID vaccine on 5/10/21 at unknown time of day. At 09:30 on 5/11 found by her mother with AMS, nausea/vomiting, erythema to L arm . Pt required benadryl, epi x 3 IM with subsequent drip and ultimately intubation.
63 2021-05-11 feeling abnormal I have had a high fasting blood sugar, severe fatigue, lightheadedness, brain fog.
63 2021-05-11 feeling abnormal 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 2021-05-12 excessive sleepiness Began having chills 16 hours post vaccine. Injection site painful and I was very tired. Slept sever... Read more
Began having chills 16 hours post vaccine. Injection site painful and I was very tired. Slept several hours more than normal
63 2021-05-14 feeling abnormal Severe fatigue, temperature spikes to 102 degrees, severe muscle, joint pain, headache, brain fog
63 2021-05-17 sleep disorder My arm was sore the same night. I had trouble sleeping on it for days. I was icing it. It got wors... Read more
My arm was sore the same night. I had trouble sleeping on it for days. I was icing it. It got worse and I had sharp pain when I tried to lift my arm. It would not go up I assumed it was going to go away with time. I saw Dr (my PCP) a month later He said it should not be still in pain and unable to be raised. He said my shoulder was frozen. I saw Dr. who said it was one of two things. The shot was given into the bursa or the needle hit a vein which bled into the bursa which caused the impingement. He has me going to therapy. It is not helping at all
63 2021-05-19 sleep disorder My arm still hurts almost 5 months later. I have shooting pains up to my shoulder and down my arm wh... Read more
My arm still hurts almost 5 months later. I have shooting pains up to my shoulder and down my arm when I try to straighten it out. I wake up in pain every morning. I cant sleep on it. I do not have full range of motion.
63 2021-05-20 feeling abnormal 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 agitation 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 feeling abnormal Woke up at 4 am. Very nauseated. Headache. Achy. Sore Arm. Went to bathroom and went back to bed. Aw... Read more
Woke up at 4 am. Very nauseated. Headache. Achy. Sore Arm. Went to bathroom and went back to bed. Awoke again at 7 am with those same symptoms intensified. All day was so tired, weak, nauseated, no vomiting. Headache and neck ache. Arm where shot is is very very sore. Felt like I was in a fog. Tried to nap but could not get comfortable. I am normally achy because of Fibro and arthritis. This seemed to cause a horrible flair. Felt so flu like. . Took my temp twice. 99 both times. Chills a little. Did not last long at all. Sweaty then chilled a bit. Only happened twice. It is now almost 30 hours since shot and I am feeling better. So The worse part was about 14 hours. Still achy. Not as bad. Arm hurts like hell still! Not so foggy feeling. Still no energy and weak legs but that seems to be getting better now.
63 2021-05-23 excessive sleepiness The normal symptoms started in about 12 hours. Chills, but hot body, sleeping alot. Achey bones, ev... Read more
The normal symptoms started in about 12 hours. Chills, but hot body, sleeping alot. Achey bones, even skin. Nausea, headache, fever 102. The second day was noticeably louder tinnitus, teeth hurt, inner ear weird feeling, no appetite, 103 temp. 3rd day was 103 temp, lightheaded, achey, 2 hives at the site but very large, warm and hard. Lower back and neck were really warm. Suddenly small pits in part of my gum that continued to spread, even under my tongue. Very sore and burned with everything I ate or drank. My body seemed to be very itchy at night. Temp went down tho. The 4th day, today was sore mouth, lips peeling and chapped, still lightheaded and arm site is sore and warm.
63 2021-05-23 excessive sleepiness Patient stated that Tuesday evening (the day she got vaccine) she became very tired. Pt stated she s... Read more
Patient stated that Tuesday evening (the day she got vaccine) she became very tired. Pt stated she slept great through the night but woke up and fell like she "hit a brick wall". Pt stated she was extremely tired, achy, chills, no appetite and slept all day. Pt stated she felt better Thursday morning.
63 2021-05-25 disorientation, feeling abnormal 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 2021-05-25 feeling abnormal Fever 104. stiff neck at the base of the skull with pain to move in all directions, foggy, fatigued
63 2021-05-25 sleep disorder, loss of personal independence in daily activities The injection was painfu. It was administred near the shoulder joint. I felt extreme pain in my enti... Read more
The injection was painfu. It was administred near the shoulder joint. I felt extreme pain in my entire arm starting 2 hours after the injection and I could not lift or use any part of it. The following night I barely slept and could not get out of bed the next day due to pain throughout my body. I also felt nauseous and vomited. Today I still cannot use my shoulder and lift my arm. As a result of motion restriction, I cannot go about my daily activities. I called the pharmacy and reported my side effects. The pharmacist agreed that I may present with SIRVA.
63 2021-05-26 feeling abnormal inflammation around the heart; Hot then cold; Brain fog; chills; This spontaneous case was reported ... Read more
inflammation around the heart; Hot then cold; Brain fog; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation around the heart) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A TCP#4 and 008B212A TCP#4) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Positive. Nasal swabaf) on 05-Jan-2021, Vitamin D deficiency and Anxiety. Concurrent medical conditions included Drug allergy (allergy to trimpex), Drug allergy (allergy to macrodantin), Perfume sensitivity (allergy to stromg smells like perfume) and Seasonal allergy. Concomitant products included HYDROXYZINE for Anxiety, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) for Eye disorder prophylaxis, CETIRIZINE HYDROCHLORIDE (ZYRTEK) for Seasonal allergy, VITAMIN D3 for Vitamin D decreased, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 23-Mar-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot then cold), FEELING ABNORMAL (Brain fog) and CHILLS (chills). On 09-May-2021, the patient experienced INFLAMMATION (inflammation around the heart) (seriousness criterion hospitalization). The patient was hospitalized on 10-May-2021 due to INFLAMMATION. At the time of the report, INFLAMMATION (inflammation around the heart), FEELING OF BODY TEMPERATURE CHANGE (Hot then cold), FEELING ABNORMAL (Brain fog) and CHILLS (chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test positive: positive (Positive) nasal swab. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that the patient spent a day and a half in the hospital, many tests were done and the patient is being treated for inflammation around the heart. More tests are coming up in two weeks. Very limited information regarding this event has been provided at this time. Further information has been requested. This case was linked to MOD-2021-057833 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
63 2021-05-27 disturbance in attention, feeling abnormal I have continually had headaches and "hazy headed" feeling since my first dose of the vaccine. More... Read more
I have continually had headaches and "hazy headed" feeling since my first dose of the vaccine. More difficulty focusing and experiencing some word loss issues.
63 2021-06-01 panic attack 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 feeling drunk 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 impaired work ability, loss of personal independence in daily activities, feeling abnormal 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 2021-06-06 agitation 7 days post vaccine administration pt developed lumps/rash at injection site. Upon waking up the fol... Read more
7 days post vaccine administration pt developed lumps/rash at injection site. Upon waking up the following day pt reports having trouble swallowing, shoulder was swollen, itchy and redness at the site. Accompanied by agitation and itchiness.
63 2021-06-07 disturbance in attention So the 2nd dose, it started within 5 -6 hours - for 24 hours after vaccine - I could barely move. I ... Read more
So the 2nd dose, it started within 5 -6 hours - for 24 hours after vaccine - I could barely move. I felt like I had a lead weight in. My daughter in law had to help me get to the restroom. I could not eat or drink. I couldn't focus on anything. I was completely out of it for at least 24 hours - and still ongoing with fatigue; problems with mobility and joint stiffness, pain and tenderness. Extreme thirst - I drank three or four liters of seltzer or water before I got sick and during that night. It is still going on -the joint stiffness - especially in the morning and tenderness over long bones. Mobility is very limited and different then it had been before. And I feel extremely fatigued. I developed kind of arthritis - I have been referred to Rheumatologist - which I've never had before. I am theoretically disabled right now. I'm sure it's from vaccine.
63 2021-06-07 feeling abnormal 5/12/21 felt sudden pain, burning sensation to Left side of left breast, swelling sensation of L bre... Read more
5/12/21 felt sudden pain, burning sensation to Left side of left breast, swelling sensation of L breast, left under arm, below left collar bone area. Used icepacks, motrin, extra-strength tylenol for 4 days. Pain reduced slightly, but for 2 more weeks felt off & on left arm pit, and left arm swelling, sensation of fluid under skin near left chest, left upper back, left upper side. Minor relief by keeping left arm elevated, wearing a compression sleeve, wearing a sports bra all day and at night. Swelling is not going away. It increases and decreases but never feels normal. Its now 4 weeks. Inaddition to the above I had the expected side effects: bodyaches, left arm injection pain, tired, low grade temp, headache, foggy head for 10 days.
63 2021-06-09 memory impairment 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 2021-06-10 feeling abnormal PATIENT RECEIVED DOSE #2 OF MODERNA VACCINE ON 5/28/21 (SECOND DOSE WAS SCHEDULED FOR 6/3/21). PATI... Read more
PATIENT RECEIVED DOSE #2 OF MODERNA VACCINE ON 5/28/21 (SECOND DOSE WAS SCHEDULED FOR 6/3/21). PATIENT RECEIVED SECOND DOSE 22 DAYS AFTER FIRST DOSE (APPROPRIATE WINDOW IS 24 TO 28 DAYS AFTER FIRST DOSE), PATIENT BEGAN HAVING SYMPTOMS DAY FOLLOWING VACCINE, LOW FEVER, ONGOING HEADACHE, EXTREME VERTIGO, UNABLE TO STAND ON HER FEET FOR LONG PERIODS, UNLIKE HERSELF, OUT OF IT. PATIENT WENT TO PCP ON 6/8/21 AND TRANSMITTED VIA SQUAD TO HOSPITAL WHERE SHE IS STILL CURRENTLY INPATIENT. ALL TESTS/LABWORK/SCANS HAVE COME BACK NEGATIVE FOR PROBABLE CAUSES. MEDICAL TEAM CANNOT DETERMINE IF THIS IS FROM THE VACCINE OR FROM THE TIMING OF THE VACCINE, BUT CANNOT RULE IT OUT EITHER.
63 2021-06-12 anxiety, crying Pt received her 2nd Moderna vaccine and 2 minutes later started experiencing very hot flashes and... Read more
Pt received her 2nd Moderna vaccine and 2 minutes later started experiencing very hot flashes and face turned completely red. She begin to cry due to pain and anxiety. I quickly gave her one dose of EpiPen 0.3mg and Diphenhydramine 50mg/ml. EMT were called and came to assist. She was taken to hospital.
63 2021-06-16 amnesia, mental impairment Loss of memory; Difficulty answering questions; Bronchitis; Major personality change; Flu like sympt... Read more
Loss of memory; Difficulty answering questions; Bronchitis; Major personality change; Flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AMNESIA (Loss of memory), MENTAL IMPAIRMENT (Difficulty answering questions), BRONCHITIS (Bronchitis) and PERSONALITY CHANGE (Major personality change) 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 information was reported. 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 AMNESIA (Loss of memory) (seriousness criterion hospitalization), MENTAL IMPAIRMENT (Difficulty answering questions) (seriousness criteria hospitalization and medically significant), BRONCHITIS (Bronchitis) (seriousness criterion hospitalization) and PERSONALITY CHANGE (Major personality change) (seriousness criterion hospitalization). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). The patient was hospitalized on sometime in April 2021 due to AMNESIA, BRONCHITIS, MENTAL IMPAIRMENT and PERSONALITY CHANGE. At the time of the report, AMNESIA (Loss of memory), MENTAL IMPAIRMENT (Difficulty answering questions) and PERSONALITY CHANGE (Major personality change) had not resolved and BRONCHITIS (Bronchitis) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication and treatment information were not reported. The patient received her first shot in early April 2021. She could not remember the exact date or lot number. Within a few minutes, the vaccination provider noticed that the patient had a major personality change, loss of memory, and difficulty answering questions. The patient was sent to the hospital because of this. While there, they informed her that she had bronchitis. The hospital sent her home and the patient was asked to monitor herself for three days. The patient's mental symptoms were reported as still ongoing. The patient also mentioned that she experienced two weeks of flu-like symptoms. 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 feeling abnormal 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 feeling abnormal Fever, chills, muscle soreness, body aches, overall yuckiness for ~36 hours
63 2021-06-16 panic attack 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 2021-06-17 memory impairment 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 feeling abnormal, insomnia Consumer mentioned he/she has problem of facial neuralgia (left side) and it has worsened after gett... Read more
Consumer mentioned he/she has problem of facial neuralgia (left side) and it has worsened after getting vaccination dose, it is twitching more/progressively worsened/obviously so much pain was there in left arm; Consumer called doctor after another week as shoulder hurt and couldn't' lift arm to certain extent/Limited movement was there along with pain/Consumer stated that he/she cannot hold hair dryer or getting dressed also hurts; Regular orthopedic doctor said it can be from shoulder injury related to vaccine shot; it is twitching more; He/she doesn't get sleep at night and try to lay down during day but it is hard; Consumer mentioned that shoulder upper arm hurts; Arm hurt; Arm hurt,it was hurting bad,Cannot hold hair dryer or getting dressed also hurts; Swollen arm; Burning sensation; Couple of days later on 24 Mar2021 was given Prednisone treatment. There was weird feeling/feeling strange; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Consumer mentioned he/she has problem of facial neuralgia (left side) and it has worsened after getting vaccination dose, it is twitching more/progressively worsened/obviously so much pain was there in left arm) in a 63-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 Facial neuralgia. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), BURNING SENSATION (Burning sensation), FEELING ABNORMAL (Couple of days later on 24 Mar2021 was given Prednisone treatment. There was weird feeling/feeling strange), PAIN IN EXTREMITY (Arm hurt) and MYALGIA (Arm hurt,it was hurting bad,Cannot hold hair dryer or getting dressed also hurts). On an unknown date, the patient experienced CONDITION AGGRAVATED (Consumer mentioned he/she has problem of facial neuralgia (left side) and it has worsened after getting vaccination dose, it is twitching more/progressively worsened/obviously so much pain was there in left arm) (seriousness criterion medically significant), MOBILITY DECREASED (Consumer called doctor after another week as shoulder hurt and couldn't' lift arm to certain extent/Limited movement was there along with pain/Consumer stated that he/she cannot hold hair dryer or getting dressed also hurts), LIMB INJURY (Regular orthopedic doctor said it can be from shoulder injury related to vaccine shot), MUSCLE TWITCHING (it is twitching more), INSOMNIA (He/she doesn't get sleep at night and try to lay down during day but it is hard) and ARTHRALGIA (Consumer mentioned that shoulder upper arm hurts). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; MELOXICAM at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (Consumer mentioned he/she has problem of facial neuralgia (left side) and it has worsened after getting vaccination dose, it is twitching more/progressively worsened/obviously so much pain was there in left arm), PERIPHERAL SWELLING (Swollen arm), BURNING SENSATION (Burning sensation), FEELING ABNORMAL (Couple of days later on 24 Mar2021 was given Prednisone treatment. There was weird feeling/feeling strange), MOBILITY DECREASED (Consumer called doctor after another week as shoulder hurt and couldn't' lift arm to certain extent/Limited movement was there along with pain/Consumer stated that he/she cannot hold hair dryer or getting dressed also hurts), LIMB INJURY (Regular orthopedic doctor said it can be from shoulder injury related to vaccine shot), MUSCLE TWITCHING (it is twitching more), INSOMNIA (He/she doesn't get sleep at night and try to lay down during day but it is hard), PAIN IN EXTREMITY (Arm hurt), MYALGIA (Arm hurt,it was hurting bad,Cannot hold hair dryer or getting dressed also hurts) and ARTHRALGIA (Consumer mentioned that shoulder upper arm hurts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant information not provided. Treatment medication includes Steroid injection as well. 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. Additionally, patient's medical history can also have compounding effects that can also contribute to a possible causal relationship. 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. Additionally, patient's medical history can also have compounding effects that can also contribute to a possible causal relationship. Further information has been requested.
63 2021-06-20 feeling abnormal Migrain, light sensitivity , brain fog .lots of pressure
63 2021-06-20 feeling abnormal 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 loss of personal independence in daily activities, impaired work ability 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 feeling abnormal headaches, bodyaches, exhaustion, heartburn, feels like am having a heart attach
63 2021-06-21 loss of personal independence in daily activities no range of motion immobilize; frozen shoulder/inflammation in my shoulder area; hard for her to get... Read more
no range of motion immobilize; frozen shoulder/inflammation in my shoulder area; hard for her to get out of bed; The patient states that she cannot function on left side, cannot wash her hair, reports no range of motion on left side; edema on her shoulder; huge muscle knots/Large lumps (muscle knots) appeared on my shoulder-neck; pain went into her shoulder and neck; inflammatory reaction; lump in shoulder; body aches; headaches; Shoulder pain became severe; arm hurt; little range of motion on her arm/Severe pain in left arm radiating up through shoulder/neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMOBILE (no range of motion immobilize) and PERIARTHRITIS (frozen shoulder/inflammation in my shoulder area) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hay fever and Allergy to animal dander (Animal hair). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 05-Oct-2010 to an unknown date for Allergy. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (little range of motion on her arm/Severe pain in left arm radiating up through shoulder/neck). On an unknown date, the patient experienced IMMOBILE (no range of motion immobilize) (seriousness criterion medically significant), PERIARTHRITIS (frozen shoulder/inflammation in my shoulder area) (seriousness criterion medically significant), GAIT INABILITY (hard for her to get out of bed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (The patient states that she cannot function on left side, cannot wash her hair, reports no range of motion on left side), OEDEMA (edema on her shoulder), MUSCLE SWELLING (huge muscle knots/Large lumps (muscle knots) appeared on my shoulder-neck), NECK PAIN (pain went into her shoulder and neck), INFLAMMATION (inflammatory reaction), SWELLING (lump in shoulder), MYALGIA (body aches), HEADACHE (headaches), ARTHRALGIA (Shoulder pain became severe) and VACCINATION SITE PAIN (arm hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CORTISONE in February 2021 for Frozen shoulder, at an unspecified dose and frequency and Physical therapy (15 sessions) for Periarthritis. At the time of the report, IMMOBILE (no range of motion immobilize), PERIARTHRITIS (frozen shoulder/inflammation in my shoulder area), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (The patient states that she cannot function on left side, cannot wash her hair, reports no range of motion on left side), INFLAMMATION (inflammatory reaction), SWELLING (lump in shoulder), PAIN IN EXTREMITY (little range of motion on her arm/Severe pain in left arm radiating up through shoulder/neck) and ARTHRALGIA (Shoulder pain became severe) had not resolved, GAIT INABILITY (hard for her to get out of bed), OEDEMA (edema on her shoulder), MUSCLE SWELLING (huge muscle knots/Large lumps (muscle knots) appeared on my shoulder-neck), NECK PAIN (pain went into her shoulder and neck) and VACCINATION SITE PAIN (arm hurt) outcome was unknown and MYALGIA (body aches) and HEADACHE (headaches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Magnetic resonance imaging: frozen shoulder (abnormal) Doctor determined frozen shoulder right after the vaccine. In February 2021, X-ray: frozen shoulder (abnormal) Doctor determined frozen shoulder right after the vaccine. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment included over the counter pain relievers, applied heat and did stretching exercises. There was no relief, then tried a session with an acupuncturist and a therapeutic masseuse- neither helped this condition. 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. Patient visited orthopedist specializing in the shoulder on 08-Feb-2021, had X-rays and MRI scans taken over the next few days. Doctor determined frozen shoulder developed right after the vaccine. In April, the pain had not subsided, and patient's condition had not improved. Patient took a second cortisone shot which was not helpful. Soon after, the physical therapist and the patient came to the conclusion that therapy was not working. The pain was constant, her range of motion was very limited. There was no improvement despite following doctor's treatment plan. The shoulder lumps/muscle knots are large. On 08-Jun-2021, patient was examined by a renown sports injury orthopedist. He determined that patient might need surgery. He explained that the inflammation in her shoulder area was an inflammatory reaction to the Moderna vaccine. In an effort to avoid surgery, patient was referred to a doctor of Physiatry who will be administering another cortisone shot and will be overseeing next step, possibly another round of physical therapy. Surgery for these situations was complicated and there was no guarantee of recovery. Also, patient was in perfect health before this vaccine and it is evident that she was suffering a reaction to the Moderna 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. This case was linked to MOD-2021-186544 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non significant follow up On 09-Jun-2021: Follow up received on 09-Jun-2021 and contain significant information. Added medical history, treatment medication and lab data. Added new events "shoulder pain became severe"(PT-arthralgia) , "inflammatory reaction to the vaccine"(PT-inflammation),"Severe pain in left arm radiating up through shoulder/neck"(added to PT-pain in extremity). The outcome of the events headache and body ache changed from unknown to recovered. Added batch number for dose two vaccine. Updated concomitant drug details, height, weight and race of the patient and reporter from other HCP to consumer.; 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 2021-06-21 sleep disorder Patient is having soreness and pain that radiates down her arm to her elbow and fingers. She is stil... Read more
Patient is having soreness and pain that radiates down her arm to her elbow and fingers. She is still reporting soreness that is disturbing her sleep. Followed up with patient on 6/17/21 and patient is still experiencing pain and side effects. Muscle soreness is the primary complaint. Patient did not disclose other medications that she is on. Patient is seeing oncologist for a previously diagnosed stage 3 vaginal cancer. Patient signed a consent form assuming responsibility for follow up regarding side effects with her doctor.
63 2021-06-22 abnormal behaviour Out of it and not acting like herself; Dizzy; 2nd dose administered before 25 days; This spontaneous... Read more
Out of it and not acting like herself; Dizzy; 2nd dose administered before 25 days; This spontaneous case was reported by a pharmacist and describes the occurrence of ABNORMAL BEHAVIOUR (Out of it and not acting like herself) and DIZZINESS (Dizzy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 3041B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced ABNORMAL BEHAVIOUR (Out of it and not acting like herself) (seriousness criterion hospitalization), DIZZINESS (Dizzy) (seriousness criterion hospitalization) and OFF LABEL USE (2nd dose administered before 25 days). At the time of the report, ABNORMAL BEHAVIOUR (Out of it and not acting like herself), DIZZINESS (Dizzy) and OFF LABEL USE (2nd dose administered before 25 days) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient that received the Moderna 2nd dose 28-MAY-2021 (Exp; 10-Apr-21) 22 days after the 1st dose. Patient's daughter reported that the patient was dizzy, out of it and not acting like her after the 2nd dose. The patient was admitted to the hospital. 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 report refers to a case of Off label use for mRNA-1273, lot # 3041B21A with no associated AE. No concomitant medicines were reported. No treatment information were reported.; 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. This report refers to a case of Off label use for mRNA-1273, lot # 3041B21A with no associated AE.
63 2021-06-22 loss of personal independence in daily activities After the first injection, left arm was very painful and continued even up to the 2nd injection. I d... Read more
After the first injection, left arm was very painful and continued even up to the 2nd injection. I decided to get the 2nd injection in the same arm because I didn't want both arms hurting like this. The second injection was given on 4/29/21. It was Moderna, Lot # ER8735 At that time the arm got worse. It was achy and warm all the time. At some point the pain moved up my arm and into my shoulder. I got to where it was difficult to use that arm in certain tasks like putting seatbelt on, putting hand on hip, crossing arms in front to pull off shirt, unfastening bra behind me, etc
63 2021-06-22 loss of personal independence in daily activities On 6/12/2021 around 2pm I noticed the redness around my arm. The right arm was extremely sore which ... Read more
On 6/12/2021 around 2pm I noticed the redness around my arm. The right arm was extremely sore which stopped me from being able to use it during daily/normal activities.
63 2021-06-23 impaired work ability 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 2021-06-28 amnesia Severe nausea, cognitive impaired, fever, chills, night sweats, memory loss, dizziness
63 2021-06-28 feeling abnormal 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 sleep disorder 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 feeling abnormal Severe fatigue, stiffness in neck, shoulders, knees and thighs, brain fog, blurred vision, jaw pain ... Read more
Severe fatigue, stiffness in neck, shoulders, knees and thighs, brain fog, blurred vision, jaw pain First started on May 9th, got worse on May 23 rd, continued on into June, went to see Dr. at Hospital on June 3rd, after looking at blood tests and brain MRI results, he diagnosed it as PMR (Polymyalgia Rheumatica) on June 3rd, prescribed Prednisone. I started taking 10mg prednisone from June 5, Got some relief, but not 100%, started taking 20mg prednisone from June 17 to July 1st. Since July 1st, alternating 20mg and 15mg. The symptoms have still not gone away completely. I still feel the fatigue and some stiffness with any small activity.
63 2021-07-01 sleep disorder 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 2021-07-06 anxiety, sleep disorder, crying I experienced about three weeks after my vaccine, I developed headaches that came and and my headach... Read more
I experienced about three weeks after my vaccine, I developed headaches that came and and my headaches have became worse with time passing to the point I am not eating or sleeping. I do not know what is happening with me. I have a doctor's appointment next week to see my doctor and I am really anxious and crying about how I am feeling about my headaches that wont go away.
63 2021-07-06 feeling abnormal 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 feeling abnormal -Swelling at injection site (approx. the size of an orange), swelling went down, then I had a odd fe... Read more
-Swelling at injection site (approx. the size of an orange), swelling went down, then I had a odd feeling running down to my elbow, and the next morning it had settled in my hip, and then moved to my sacrum. The feeling and movement of the vaccine was something like I had never felt before (it hurt terribly and it felt like what ever it was was stuck). I ended up in PT for a month to straighten out my sacrum, hip, and disks). I had done nothing to spur any injury on, I am in shape and work out every other day. Vaccine dose #2 I had a sleeve of red from the injection site, down to my elbow, and down my side for two weeks...I then acquired neuropathy in those same areas, and then it developed into full blown shingles (of which is still not completely gone). I never had the chicken pox as a child. The physician that I saw in my doctors office the day I went in for the rash (not my normal doc), said that they had an uptick in shingles cases from people who were approx.. 6 weeks from their second vaccine.
63 2021-07-07 confusional state Patient reports having an adrenal crisis consisting of N/V/V, chills and confusion.
63 2021-07-08 feeling abnormal, loss of personal independence in daily activities After the 4th day of the shot I wasn't feeling good, I was always dizzy, Short of Breath, Exhausted ... Read more
After the 4th day of the shot I wasn't feeling good, I was always dizzy, Short of Breath, Exhausted where it was hard to even get out of bed. Even trying to clean my house made it worse where I could not catch my breath. I could not drive do to my condition my Husband had to take off of work to take me to my Doctors Office
63 2021-07-10 loss of personal independence in daily activities Shot was given at shoulder/arm joint, and resulted in pain, swelling, fever for about 1 month, after... Read more
Shot was given at shoulder/arm joint, and resulted in pain, swelling, fever for about 1 month, after that, only the shoulder pain, which renders me unable to do many things, and many days cannot move more than a few inches.
63 2021-07-13 feeling abnormal 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 loss of personal independence in daily activities Patient states that on the first vaccine she experienced a bad headache which is a common side effec... Read more
Patient states that on the first vaccine she experienced a bad headache which is a common side effect. She states it was the second dose that caused her to have issues with dizziness within an hour after having the second dose. She states the dizziness isn't positional and has been on and off she since had the second dose back in April. She also still has reoccurring headaches and isn't sure if these are contributed to it but the most concern is the dizziness as she states she has a few times where she has had to pull over while driving because of it.
63 2021-07-18 impaired work ability Systemic: Joint Pain-Severe, Additional Details: Pt experienced severe joint pain in whole body whic... Read more
Systemic: Joint Pain-Severe, Additional Details: Pt experienced severe joint pain in whole body which sent her to ER and orthopedic specialist a month and half after the vaccine. Drs have nothing else to attribute severe joint pain to after tests and xrays. Pt missed several days of work and still is experiencing joint pain that drs are not sure what to do. Pt wrists and fingers were swollen and could not be contributed to carpel tunnel or other causes according to dr.
63 2021-07-22 sleep disorder, irritability I started having leg cramps in the middle of the night and had to ice both shoulders. I previously h... Read more
I started having leg cramps in the middle of the night and had to ice both shoulders. I previously had problems with my rotator cuff earlier in the year - I had to ice both even though I didn't do anything with the arm that didn't have the shot. I also had to ice my neck, which is when I decided to go to the doctor. It's like having menopause again but worse. I was already wearing a pee pad but instead of every 12 hours at night I would have terrible cramps and before being able to go to the bathroom I would already pee. And I work at Amazon in the warehouse and do manual labor so I know the difference in the feeling of being worn out but I didn't do anything and had all these cramps. I had a low grade fever a lot, which is still continuing. I checked with the doctor to make sure I wasn't having an infection. I had exhaustion beyond the regular and headaches. problems with my feet, foot fungus that's getting worse and things that used to fix it aren't. Not getting enough sleep, irrigatable.
63 2021-07-25 feeling abnormal, loss of personal independence in daily activities ? Extreme exhaustion. Unable to perform daily functions. As of 7/26/21 I am still experiencing this... Read more
? Extreme exhaustion. Unable to perform daily functions. As of 7/26/21 I am still experiencing this debilitating adverse effect. ? Severe Headaches. I had never experienced such severe headaches before and now I have them frequently. ? Brain Fog. Frequently I am unable to think clearly. ? Swollen lymph nodes. These come & go but 3 months after the vaccination I still have knots that come & go in my armpit area. ? Cough. ( I have never smoked not been subjected to 2nd hand smoke ). I now frequently have a cough that has not gone away since the vaccination. ? Vomiting. I have vomited more since the vaccination than I have in my entire life combined. The vomiting does not appear to be related to eating and I?m fine afterward until the next episode. My entire life changed the day I received the Moderna COVID-19 second dose vaccination. I no longer have the energy to exercise. Prior to the vaccination I was walking 5-7 miles daily and had been for more than 15 years. I no longer can enjoy life as I am too exhausted to function normally.
63 2021-07-27 anxiety 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 disturbance in attention 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 excessive sleepiness, feeling abnormal 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.
63 2021-07-27 sleep disorder 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 sleep disorder I was woken up by a severe headache in the area behind my left ear. I went to brush my teeth and the... Read more
I was woken up by a severe headache in the area behind my left ear. I went to brush my teeth and then looked in the mirror and saw my face and that the toothpaste could not stay in my mouth. The entire left side of my face had fallen about an inch. I could tell because my eyebrows were not even. The headache continued for several days but not as severe as the initial event. I could not use the muscles on the left side of my face at all. Initially, I was afraid to go to the hospital because of the level of COVID in my area but I did take pictures throughout the several weeks of my recovery.
64 2021-01-01 feeling abnormal Hours after the vaccine developed cough, tiredness, neck aches, chills, headache, orbital pain, naus... Read more
Hours after the vaccine developed cough, tiredness, neck aches, chills, headache, orbital pain, nausea. By that evening had fever 100.6 in addition to other symptoms. Next morning same symptoms. That afternoon, extreme tiredness along with prior symptoms. That evening fever 102.8. Next morning, exteremely dizzy, head foggy, orbital pain, minor cough. By Thursday no better so got covid test.
64 2021-01-03 anxiety, nervousness Anxiety attack lasting 2 hours,. Took some benadryl and wellbutrin. Within 40 minutes calmed down en... Read more
Anxiety attack lasting 2 hours,. Took some benadryl and wellbutrin. Within 40 minutes calmed down enough, until the next day started feeling shaky and anxious again..called Dr. at home. She says to take my wellbutrin in the morning as well as my evening dose and benedryl every 4 hours. Has been good since then.
64 2021-01-03 feeling abnormal The person who gave me the shot placed the injection too low on my arm. It should have been up near ... Read more
The person who gave me the shot placed the injection too low on my arm. It should have been up near the shoulder, but instead the person gave it to me down toward the middle of my arm. I knew something was wrong immediately because it felt so warm and disruptive. The doctor on the scene said it was nothing. Nine days later I went to Urgent Care with swelling, hot-to-the-touch, itchy and a huge knot. The Urgent Care Dr. gave me a five-day prescription for Prednisone and also gave me a prescription for hydroXYzine pamoate, which is an antihistimine.
64 2021-01-05 sensation of foreign body About 2 hours after injection, patient felt a big lump on throat to the point of it almost closing. ... Read more
About 2 hours after injection, patient felt a big lump on throat to the point of it almost closing. Pt got over the counter benedryl and took some on her way home from work where she received the vaccine. Had chills during the night. Patient still has lump on throat but it is about 50% recovered. Throat is sore also and voice changed a bit.
64 2021-01-08 anxiety 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 2021-01-08 confusional state Confusion, Headache, Myalgia, Fever, Nausea Vomiting, Chills, Fatique, difficulty to wake in am, pai... Read more
Confusion, Headache, Myalgia, Fever, Nausea Vomiting, Chills, Fatique, difficulty to wake in am, pain redness in injection site
64 2021-01-08 feeling abnormal Immediate metallic taste in my mouth, followed by itching of arms neck and throat. About 10 minutes ... Read more
Immediate metallic taste in my mouth, followed by itching of arms neck and throat. About 10 minutes post shot, my tongue felt like it was swelling, that swelling only lasted about 20 seconds. Shortly after that I had an overall feeling of tiredness,lethargic and foggy brain. All of these symptoms lasted about three and a half hours. At about four hours after the shot, I began to have diarrhea.
64 2021-01-08 impaired work ability, excessive sleepiness, sleep disorder Intense left arm pain awakening me from sleep, fever 101.4, unable to hold down food or water, slept... Read more
Intense left arm pain awakening me from sleep, fever 101.4, unable to hold down food or water, slept for almost 24 hours, could not go into work on 1/8/21.
64 2021-01-09 feeling abnormal Fever, chills, muscle aches, headache, brain fog Started 10 hours after vaccine administration, last... Read more
Fever, chills, muscle aches, headache, brain fog Started 10 hours after vaccine administration, lasted 24 hours
64 2021-01-10 feeling abnormal @ 11:25 felt lips go numb, called for help. Talking. Became hoarse, "felt funny". Benadryl 25 mg ... Read more
@ 11:25 felt lips go numb, called for help. Talking. Became hoarse, "felt funny". Benadryl 25 mg PO given @ 11:25 a.m. BP 150/92. Pulse 106. Resp 20 Pt remained for total of 30 minutes. Symptoms resolved
64 2021-01-10 impaired work ability Headache, NauseaVomiting, Swelling, Tinnitis Narrative: Missed 3 days of work so far due to the h... Read more
Headache, NauseaVomiting, Swelling, Tinnitis Narrative: Missed 3 days of work so far due to the headache, 1 of the days she said it was a migraine. Hasn't had migraines in over 15 years..Headaches continue at this time 1/11/2021
64 2021-01-11 feeling abnormal 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 2021-01-11 excessive sleepiness [Received injection ~8:30-9:00 AM.] "Noticed around 12:10 PM and went upstairs right away that my ar... Read more
[Received injection ~8:30-9:00 AM.] "Noticed around 12:10 PM and went upstairs right away that my arm had all these red blatches, arm was swollen, itching really bad , felt my chest beating really fast, [vaccine administrator] made me sit down and gave me 50mg of Benedryl. I left and went home got there within 40 minutes and fell asleep right away. Slept for about 2 days straight. When I finally woke up my body was so sore and achey, felt pain all over had to take Tylenol (2) 500 mg every 6 hours for 3 days before getting some relieve. Didn?t see a Dr. Felt 100% by Tuesday 1/12."
64 2021-01-13 feeling abnormal The night of vaccination (12/28/20), pt developed mental "fogginess" with impaired alertness, remain... Read more
The night of vaccination (12/28/20), pt developed mental "fogginess" with impaired alertness, remained oriented x4. She saw her primary care physician who ordered bloodwork and a brain MRI. On 1/8/21 pt reported that the mental fogginess had improved but she had developed a rash at the injection site. The rash cleared by 1/14/21.
64 2021-01-13 nervousness 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 2021-01-14 anxiety Acute anxiety reaction.
64 2021-01-18 excessive sleepiness, feeling abnormal On January 14th woke up with a headache and extremely tired. Slept on / off most of day. On January ... Read more
On January 14th woke up with a headache and extremely tired. Slept on / off most of day. On January 16 woke up feeling great and about 3:30 in the afternoon with no warning extreme dizziness and nausea came over me. Felt so awful, tried to eat something, vomited immediately. Felt so horrible, had to go to bed, slept on and off throughout the night. Woke up Sunday, feeling better, not 100%. I?m concerned if on January 16th was a reaction because it was two full days after receiving the injection.
64 2021-01-18 insomnia, excessive sleepiness Hello, i took the Moderna 1/4 and am scheduled for 2nd shot 2/1. I just wanted to pass on some side ... Read more
Hello, i took the Moderna 1/4 and am scheduled for 2nd shot 2/1. I just wanted to pass on some side effects and i did not go on the agency website which i should have to report them. I had a headache off and on the first week. the first day afterward i had a 100 degree fever as well. I never have sleep issues (falling asleep etc) i had insomnia and could not sleep and didnt sleep well for around a week. What i noticed most though is it really affected my stomach and i was awakened with acid reflux several times. the muscles of my stomach were sore like i had been coughing (but hadn't) and i had no desire for food, only fruit, light watery things. as soon as i eat anything i have stomach pain digesting. Since last weekend i sleep way too much, even if i set the alarm i turn it off and keep sleeping. I try to walk and get out. when i wake up it seems my stomach has been really active, i have a horrible taste in my mouth and acid reflux liquid in my through. Just letting you know; and I have the 2nd shot so fingers crossed i'll come through all of this. Take care as well. Thanks
64 2021-01-19 sleep disorder snored all night so loudly that it kept waking me up got up in the am, had coffee and then back to b... Read more
snored all night so loudly that it kept waking me up got up in the am, had coffee and then back to bed until 1 pm and contifnued to snore nonstop as during the nighttime very unusual for me, never snore like this and never sleep during the day
64 2021-01-21 loss of personal independence in daily activities Started with a severe HA the day after with extremely sore and hot arm. Progressed to weakness and ... Read more
Started with a severe HA the day after with extremely sore and hot arm. Progressed to weakness and flu-like symptoms with low grade fever of 101. Was off work for 2 days unable to hardly get out of bed. Then on day 2 post vaccine, started with lower abd pain, sharp and continuous. Day 3 post vaccine, feeling much better but not 100%, Stomach pains continue.
64 2021-01-21 sleep disorder 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 impaired work ability 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 2021-01-24 sleep disorder Employee received vaccine at 10am, by 8pm that evening employee experienced achiness, tiredness, had... Read more
Employee received vaccine at 10am, by 8pm that evening employee experienced achiness, tiredness, had headache, joint ache, fever, cramping, can't sleep, no appetite.
64 2021-01-25 feeling abnormal, confusional state 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 impaired work ability temp aches, vomiting, Out of work.
64 2021-01-25 insomnia Temp pain in arm severe chills aching insomnia
64 2021-01-26 disorientation Confusion, Headache, Sedation, Chills, no appetite Narrative: Per nursing report:"2nd Moderna vacci... Read more
Confusion, Headache, Sedation, Chills, no appetite Narrative: Per nursing report:"2nd Moderna vaccine on 1-25-21. C/o headache, chills, disorientation on Monday [1/25]. C/o feeling tired and sleepy. Called in today [1/27]. No appetite on Monday. States thought she was having side effects from aneurysm which she states has been monitoring x4 years now."
64 2021-01-26 impaired work ability At the time of 1st dose shot (approx. 1pm) on Friday 01/08/2021 slight irritation at injection site.... Read more
At the time of 1st dose shot (approx. 1pm) on Friday 01/08/2021 slight irritation at injection site. Approximately 12:30-1:00 AM on 01/09/2021 woke up, turned my head and experienced room spinning dizziness for about 2 minutes. Had to remain completely still to stop the room spinning. For the next 2 days (until the morning of Monday 01/11/2021) I experienced on and off room spinning dizziness at unpredictable intervals. Usually didn't last longer than 2 minutes but had to remain completely still to stop the spinning. Starting on Monday 01/11/2021 had "normal" dizziness along with some flu like symptoms, headache, tiredness, soreness/achiness and extreme soreness and pain in my left upper arm where I received the vaccine shot. I stayed out of work because of the on-going dizziness. These symptoms continued until Saturday 01/16/2021. I took an antihistamine on Saturday night and finally woke up Sunday 01/17/2021 with no dizziness.
64 2021-01-26 sleep disorder Shot 1-18. Normal pain and redness at injection site. Went away. Redness, swelling and severe itchin... Read more
Shot 1-18. Normal pain and redness at injection site. Went away. Redness, swelling and severe itching at injection site today 1-27. Woke me up from sleep(itching). Took Zytrec. Is this normal? What does it mean?
64 2021-01-26 sleep disorder The instructions I received said to type: Moderna COVID-19 Vaccine EUA in the first line of box #18 ... Read more
The instructions I received said to type: Moderna COVID-19 Vaccine EUA in the first line of box #18 of the report form. 1/25/2021 - evening - sore arm below injection site, not so much at site, not unbearable but noticable 1/26/2021 - evening - feeling achy before bed, rubbed Aspercreme on sore neck, wrists, elbows, etc 1/27/2021 - just after midnight, about 12:30 am - woken by uncomfortable flu-like symptoms, very achy, joints, head, no fever 1/27/2021 - evening - notable rash patch on left arm below injection site, a little swollen and a bit itchy Took Excedrin in the morning, Tylenol in the evening Uncomfortable to Very Uncomfortable symptoms but nothing that I couldn't stand
64 2021-01-27 anxiety Patient has history of anxiety so she was anxious even before taking the vaccine but she was fine be... Read more
Patient has history of anxiety so she was anxious even before taking the vaccine but she was fine before leaving.
64 2021-01-27 feeling abnormal developed a fever in the evening that lasted all night. the next day still had some fever which prog... Read more
developed a fever in the evening that lasted all night. the next day still had some fever which progressed to chills and extreme tiredness. didn't feel "normal" until the 2nd morning afterwards. of course the injection site hurt just like any other shot.
64 2021-01-27 insomnia Headache, muscle aches, fatigue, nausea, insomnia, started around 4pm on 1/20/2021 and ended by the ... Read more
Headache, muscle aches, fatigue, nausea, insomnia, started around 4pm on 1/20/2021 and ended by the time I woke up at 6am on 1/22/2021. Took acetomenophen (unable to take NSAIDs) and lay down in darkened room. Ate small amount of BRAT diet. Felt totally recovered by 6am 1/22/2021.
64 2021-01-28 nightmare Exhausted! In bed all day. Nightmare sweating in sleep. Shaking bouts.
64 2021-01-30 disturbance in attention, feeling abnormal Day 1 after vaccination Approx 14 hrs after injection: initially:Malaise, muscle and joint aches, ... Read more
Day 1 after vaccination Approx 14 hrs after injection: initially:Malaise, muscle and joint aches, headache as day progressed: Fever of 100.8 F by 6pm (24 hrs after injection): fever a little lower, and then felt freezing cold/chills. Had to take hot shower and wear many layers of clothing. Felt fatigued, unable to concentrate. Too unstable to take a walk. Day 2 after vaccination: No fever, but felt too weak for a walk until around 8pm. then able to take a short walk. Day 3: still tired, brain fogged. Brain fog lessened but persisted until day 8 (1 week later).
64 2021-01-31 feeling abnormal sat. at 10:30pm to sun. 5:30am- chills/fever- felt like run over by train Sun. fever all day with ty... Read more
sat. at 10:30pm to sun. 5:30am- chills/fever- felt like run over by train Sun. fever all day with tylenol- highest 101.8- very fatigue Mon. am felt better, afternoon around 2pm feeling flushed temp 100.3, tired
64 2021-01-31 impaired work ability 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 2021-02-01 impaired work ability Fever 101. Body aches, chills, general malaise, no appetite, sore arm for 2 and 1/2 days. Rested, p... Read more
Fever 101. Body aches, chills, general malaise, no appetite, sore arm for 2 and 1/2 days. Rested, po fluids, Tylenol. Stayed home from work 3 days.
64 2021-02-03 disturbance in attention Mild discomfort upon injection and the following 7 days. Day 8 after injection - severe itching and ... Read more
Mild discomfort upon injection and the following 7 days. Day 8 after injection - severe itching and moderate burning at injection sight. skin was very hard surrounding injection. Day 9 in morning injection area more inflamed , red almost bruised looking and still itchy. Very very lethargic, upset stomach and inability to focus.
64 2021-02-04 anxiety, insomnia Intense pain at injection when I went to bed. Developed chills/fever, dry cough, sore throat, head... Read more
Intense pain at injection when I went to bed. Developed chills/fever, dry cough, sore throat, headache, body aches, fatigue, red eyes, sleeplessness, anxiety, fever dreams. Felt like I had Covid all over again for 3 days. Injection site was red, feverish, and raised. At 6 days, red circle was no longer raised, but 5 inches in diameter. Treated by alternately taking Tylenol and Ibuprofen, just as I had with Covid. Circle was gone on7th. day. Extreme fatigue and cough lasted for about 3 weeks.
64 2021-02-04 confusional state, impaired work ability, amnesia Reports symptoms of severe body aches, migraine type headache, memory loss, nausea, slurred speech, ... Read more
Reports symptoms of severe body aches, migraine type headache, memory loss, nausea, slurred speech, dizziness and vomiting. Symptoms occurred towards the end of her shift on 2/2. Called in ill to work on 2/3. Got the COVID-19 Moderna vaccine on Monday. On Tuesday, symptoms occurred. As the afternoon progressed, things got worse. By 4 or 5 PM, had severe nausea and felt dizzy. Then started having trouble thinking. Then vomited and had her son pick her up from work. Didn't go into work yesterday due to symptoms. States that when son picked her up, she was slurring her speech. Co-workers said that she seemed as though she was confused. Son reported that she had difficulty with buckling her seat belt. Son reports that she feel to sleep in the car on the way home.Did not know if she had a fever. Woke up yesterday morning all clammy and wet. Did not remember what had happened at work on Tuesday afternoon or after her son picked her up. Her first memory was waking up on Wednesday morning. Had COVID back in May. Went into work today. Still feels a little nausea, but other symptoms have resolved.
64 2021-02-04 restlessness slightly sore and stiff arm ( similar to tetnis shot) about 5 hours after; restless, tired, & gener... Read more
slightly sore and stiff arm ( similar to tetnis shot) about 5 hours after; restless, tired, & general feeling "unwell" about 7 hours; fever at 10 hours. Fever of 101.7 sustained from 2 AM through the day until 8 PM when it dropped to 99.8. By 10 PM fever resolved & was asymptomatic. Treatment was Tylenol, hot shower, hot bath, hydration, & rest.
64 2021-02-04 sleep disorder itching and continue to get pain in arm and wakes me up at night if i have been laying on the left
64 2021-02-07 feeling abnormal VERY SORE LEFT ARM. HEAD ACHE,WEAKNESS ,TIRED, VOMIT AND DIARRHEA,NO APPETITE AND FEVER STILL NOT 10... Read more
VERY SORE LEFT ARM. HEAD ACHE,WEAKNESS ,TIRED, VOMIT AND DIARRHEA,NO APPETITE AND FEVER STILL NOT 100% FEELING WISE ARE NOT SORE NO MORE VOMIT AND DIARRHEA OR FEVER STILL FELL WEAKISH.
64 2021-02-07 feeling abnormal Obtained 1st Moderna Covid Vaccine on 2/4/21, about 9 minutes c/o tingling all over and not feeling ... Read more
Obtained 1st Moderna Covid Vaccine on 2/4/21, about 9 minutes c/o tingling all over and not feeling good. 2:24pm-Alert, HR 179, BP 170/78, O2 sat 97%. 2:25 p.m. - Benadryl 50mg Im given R deltoid. HR 94, 2:28pm-HR 98, O2 sat 94%. 2:29pm-HR 88. 2:31pm-HR 88, O2 sat 95%. Patient still c/o not feeling well. 2:33pm Epinephrine .5 IM given R deltoid. 911 called 2:34pm-HR 114, O2 sat 92%. 2:37pm-HR 106, O2 sat 98%. 2:38pm-HR 96, O2 sat 94%. 2:39pm-HR 97. 2:40pm-HR 92, O2 sat 98%, BS-clear. 2:41pm-HR 95, O2 sat 98%. 2:43pm-EMS here to transport and took over patient care.
64 2021-02-07 insomnia 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 nervousness 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 nightmare, sleep disorder 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 2021-02-08 feeling abnormal pt stated that on the same day she started having stomach cramping and diarrhea. Next day pt woke u... Read more
pt stated that on the same day she started having stomach cramping and diarrhea. Next day pt woke up with head congestion and coughing with major drip of mucus going down her throat. She is also weak and dizzy. Three days later pt had tingling in upper lip and gum. Fourth day pt still had congestion and still had the tingling in lips and gums. Pt spoke w/ PCP on call and was told to rest. Fifth day pt still had all of the same symptoms and then she had developed a light vibrating sensation on her right side on the inside area around the breast. Pt had this symptom for the next 2 days. She went to her Pulmonologist which did not find anything wrong w/ her lungs and thought she may have hurt her back. Pt started feeling better but is still very weak. Pt stated about a week later she developed a headache that she could not get rid of. On 2/8/2021 pt still has headache. On 2/9/2021 she woke up weak and dizzy and just dont feel well. Pt is concerned about taking her 2nd vaccine.
64 2021-02-09 anxiety 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 2021-02-13 amnesia 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 feeling abnormal headache, low grade fever, weakness, chills, dry mouth, stuffy nose, sore arm. crummy feeling. tire... Read more
headache, low grade fever, weakness, chills, dry mouth, stuffy nose, sore arm. crummy feeling. tired.
64 2021-02-15 anxiety Throat and tongue tingling and sensation of swelling, diarrhea and took benadryl. At 8 hrs post vac... Read more
Throat and tongue tingling and sensation of swelling, diarrhea and took benadryl. At 8 hrs post vaccine got dizziness, throat swelling, anxiety, and had to use epipen. Went to hospital by ambulance and was further treated with prednisone and benadryl and Zofran.
64 2021-02-15 insomnia COVID-19 Vaccine EUA: I got the vaccine at 11 am on 2/15/21. There were not immediate adverse effect... Read more
COVID-19 Vaccine EUA: I got the vaccine at 11 am on 2/15/21. There were not immediate adverse effects. By 3:00PM, my arm was becoming very sore. By 8:00 PM, my right arm was extremely sore and overall body aches ensued as I began to feel weak. By 9:00 PM, I felt the need to get into bed and had chills, a severe headache and pain over my whole body, accompanied by shooting burning sensations down both arms into my palms and fingers. I had not taken any medication for the discomfort up to this point. As time went on, my pain became excruciating, I never felt this kind of pain in my entire body. I had pain in areas I never felt pain before like my arms, hands and toes. I also had extreme pain in the back of my neck, both shoulders, both arms, my hips and knees. The pain was so intense and throbbing, my headache was severe at my temples and I had chills. I did not take my temp, but I am sure I had a fever, although I was not sweating. I could not sleep at all and finally broke down at 1:30 am and took an Advil. There was minimal help with the Advil and I slept on and off over the next 4 hours. Throughout today, the headache, chills and pain continued, but slightly less and I was able to take a 2 hour nap. I think it important to note that I had more of a reaction to the first COVID shot that most others I talked with and felt an ongoing weakness after the first shot over the course of the month. I understand that some of my symptoms are part of my body's reaction to building antibodies, but with the intensity of my reaction, I have to wonder if there is more going on.
64 2021-02-16 insomnia, feeling abnormal Sat, Feb. 13, 2nd day after shot: during the afternoon arthritis pain intensified and Tylenol Extra ... Read more
Sat, Feb. 13, 2nd day after shot: during the afternoon arthritis pain intensified and Tylenol Extra Strength for Arthritis did not alleviate it, which it always has in the past. Later sometime in the middle of the night, I wasn't able to fall asleep as if I'd had a stimulant, and had intense arm pain where shot given, some nausea, some intestinal discomfort, intense pain at temples and behind eyes, overall "crappy" feeling. Sun., Feb 14, 3rd day after shot: Pains/symptoms same as above with the addition of a low grade fever (99.9), chills, fatigue, no appetite. Tylenol didn't help. Was able to drift in and out of light sleep. Later in the day, fever and majority of symptoms suddenly "left", gradually decreasing until I felt fine again by Sunday evening. No issues Monday, Feb. 15.
64 2021-02-18 disorientation 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 2021-02-18 impaired work ability 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 2021-02-20 disturbance in attention, feeling abnormal 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 2021-02-24 anxiety ANXIETY REPORTED , IMPORVED WITH DISTRACTION
64 2021-02-24 insomnia I started experiencing chills within half an hour after the shot. The following 24 hours I experien... Read more
I started experiencing chills within half an hour after the shot. The following 24 hours I experienced total insomnia, chills, headache, body ache, shoot pains, extreme weakness, and nausea. Insomnia lasted 3 nights. The other side effects began to decrease after 24 hours, but still prominent enough to prevent from actively engage in anything for another 24 hours. After the third night of insomnia, I thought I had turned the corner. But I continued to experience headache (I basically never have headache), occasional nights of insomnia (I usually sleep extremely well), and low level of nausea, and fatigue. Today, 8 days after the shot, after another night of difficulty in sleeping, I woke up with the same headache behind my right eye, nausea, weakness, and fatigue. This is when I thought to report these side effects.
64 2021-02-24 insomnia Moderna COVID-19 Vaccine EUA. Insomnia 12 hours after vaccine. headache 24 hours after the vaccine, ... Read more
Moderna COVID-19 Vaccine EUA. Insomnia 12 hours after vaccine. headache 24 hours after the vaccine, progressed to body aches, fatigue, chills, fever 101.6 Resolved after 48 hours. Red arm 6 inches by three inches started 24 hours after the vaccine, still there 36 hours after vaccine
64 2021-02-25 disturbance in attention Ocular migraine x 25 mins and extended period of difficulty focusing, comprehending and expressing m... Read more
Ocular migraine x 25 mins and extended period of difficulty focusing, comprehending and expressing myself verbally. Intermittent mild Left frontal headache associated with above. Took approx 36 hrs to resolve with subtle residual difficulty cognitively and with visual recognition of numbers and words persisting for several days
64 2021-02-25 feeling abnormal Patient stated that she felt funny EMS was called vitals HR 74 BP 142/80. Released and went home.
64 2021-02-26 feeling abnormal Tingling left side of head as walking from dosage room to waiting area. Then tingling in both hands ... Read more
Tingling left side of head as walking from dosage room to waiting area. Then tingling in both hands followed by arms tingling and mottling of skin on both arms. Very strange feeling, knowing something not right. Given 25 mg of Benadryl, observed for approximately 1 hour. Followed up with second 25 mg Benadryl approximately 4 hours later. Second day extreme soreness at injection site, no other noted adverse effects.
64 2021-03-01 anxiety 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 2021-03-02 feeling abnormal Today at 12:42 patient?s companion flagged nurse down that the pt wasn?t feeling so good. Pt reporte... Read more
Today at 12:42 patient?s companion flagged nurse down that the pt wasn?t feeling so good. Pt reported that she was feeling dizzy and was seeing flashing lights. Pt reported that she hadn?t eaten any breakfast this morning prior to getting her vaccine. Pt reported that she only had a cracker and hadn?t had water/fluids to drink today. Pt reported that she received her first Moderna vaccine today at 12:24 pm. Pt was offered some fruit to eat and tolerated food well. Pt reported she was starting to feel much better. Pt reported that her symptoms had subsided and she felt okay to leave. PHN advised pt to at least wait 30 min in total to assure that she was okay. Pt verbalized understanding and remained seated until 30 minutes passed. Pts vitals at 12:43 were 130/84 blood pressure, saturation at 96%, respirations 17, and 84 bpm. Vitals were taken again at 12:57, 122/78, 99% saturation, 80 bpm, and respirations 18. At 13:10 pts vitals were taken again, blood pressure 118/70, 97% saturation, respirations 18, and 83 bpm. Pt reported that she does not take any medications on a daily basis, but did take Tylenol this morning for a HA. Pt denied any supplements or herbal remedies. Pt denies that she has any chronic health conditions. Pt denied ever having Covid. Pt reported that she was feeling much better. Pt denied any symptoms and that her symptoms have subsided. Pt was offered some water, but stated that she had water in her car. Pt was released to go home, vitals were within normal limits, and pt was no longer having any symptoms. Pts left with her companion. Pt signed the reporting form that she was okay. PHN advised that if pts symptoms return or if she doesn?t feel well after leaving to seek immediate medical attention and/or can follow-up with her primary care provider. Pt verbalized understanding.
64 2021-03-02 sleep disorder Pain all over body, fever, chills, sore arm, couldn't sleep because body hurt so badly. Only relieve... Read more
Pain all over body, fever, chills, sore arm, couldn't sleep because body hurt so badly. Only relieved by NSAIDs taken around the clock for 24 hours
64 2021-03-03 sleep disorder Loud, intermittent mechanical buzzing in right ear; causing awakening from sleep. Persisted into nex... Read more
Loud, intermittent mechanical buzzing in right ear; causing awakening from sleep. Persisted into next the day. Headache x 3 days.
64 2021-03-07 excessive sleepiness The evening of vaccine, Saturday, I became achy and had a slight headache., went to bed early. The ... Read more
The evening of vaccine, Saturday, I became achy and had a slight headache., went to bed early. The next day, Sunday, I awoke with a splitting headache, achy all over, had a temp. of 100.6F. I stayed in bed all day and drank plenty of fluids, napped throughout the day, fell asleep early and slept most of the night. Day three, Monday, I awoke feeling OK, when I walked my dog for about 15 minutes, I got very dizzy and returned to bed for the day. No other symptoms arose but, the dizziness remained for the entire day.
64 2021-03-07 excessive sleepiness Moderna COVI 19 Vaccine EUA I woke up Sunday March 7,2021- feeling fatigue(more than usual). By 11... Read more
Moderna COVI 19 Vaccine EUA I woke up Sunday March 7,2021- feeling fatigue(more than usual). By 11:00 AM- headache, muscle pain, chills, nausea and vomiting. watery frequent stools. Vomiting in morning . Stated vomiting again at 9:00 PM and then stopped by 10:00PM. Remained nausea most of night. No sense of smell or taste on Sunday or Monday. Starting to feel alittle hungry at 8:50 PM Monday. The other symptoms lasted all day on Sunday and Monday 3/8/2021. Fever ranged from 99.2-101.4. My normal temp is around 97. Super exhausted and slept most of Monday 3/7/2021. At 8:50 PM Monday 3/8 no vomiting, no fever, muscles aches still present but improving, still feeling very tired.
64 2021-03-07 impaired work ability, disturbance in attention Headache began early afternoon and gradually the pain increased through the remainder of Friday Marc... Read more
Headache began early afternoon and gradually the pain increased through the remainder of Friday March 5,2021 and lasted through Saturday, March 6,2021 until about 6 PM where the pain subsided enough that I could function. As the pain intensified, I had throbbing pain in the temples and behind my eyes, the pain worsened even more if I bent forward, like to pick up something from the floor. My neck muscles were extremely tight. I couldn't concentrate on anything, like reading or working. I was feeling less than energetic,. Also, my left arm was red, not swollen at the injection site and hurt to touch, not as bad as the 2 days after receiving the vaccine, but I thought it was unusual that my arm was red & sore. This is what made me conclude it was a delayed reaction to the vaccine. I rarely have headaches and if I do taking 2 Ibuprofen will take care of it. Taking 2 Ibuprofen this time did absolutely nothing to ease the pain. I did increase to 800 mg of Ibuprofen late Friday and early Saturday which did help, used a cervical heating pad, hot shower to try to ease muscle tension. I was able to sleep and by Saturday evening with home remedies, the pain did subside and by Sunday March 7,2021 I felt back to normal with a slight, slight bit of headache but not much to worry about.
64 2021-03-08 confusional state 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 2021-03-08 feeling abnormal, excessive sleepiness 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 2021-03-09 feeling abnormal Her arm was sore the first couple of days and then Sunday 3/7/21 on her collarbone on her neck she h... Read more
Her arm was sore the first couple of days and then Sunday 3/7/21 on her collarbone on her neck she had a little lump that moves around, weird feeling. It was itchy, and then that's all she noticed. Then yesterday, 3/9/21, noticed tenderness going up her neck and around the lump, inward towards the middle of her throat was a little tender. On the injection site it was a little pink, but today it's not inflamed, it's redder and feels warm to touch. She may have some tenderness in her arm area at the elbow. She took Advil yesterday and not taken anything today. She called her doctor and they told her to call us.
64 2021-03-10 nervousness PATIENT C/O THICK TONGUE AND NUMBNESS 5 MINUTES AFTER VACCINATED WITH MODERNA AND WAS MONITORED FOR ... Read more
PATIENT C/O THICK TONGUE AND NUMBNESS 5 MINUTES AFTER VACCINATED WITH MODERNA AND WAS MONITORED FOR EXTRA 30 MINUTES. PATIENT THEN C/O FEELING SHAKY BECAUSE OF NOT EATING LUNCH AND PATIENT WAS GIVEN PEANUT BUTTER CRACKERS. PATIENT STATED SHE FELT BETTER AND WAS RELEASED FROM VACCINE POD.
64 2021-03-12 feeling abnormal within 5-15 minutes of injection: soreness in at injection site spread throughout arm, hand, and fin... Read more
within 5-15 minutes of injection: soreness in at injection site spread throughout arm, hand, and fingers, numbness in face - cheek, eye, nose on right side (felt like I had novocaine for right side dental work), hoarseness, cankor or cold sore (not sure I know the difference) on right lower lip, warm sensations in right calf muscle and right foot within 15-60 minutes tender lymph node right armpit, fatigued muscles in legs, brain fog
64 2021-03-12 feeling abnormal sour stomach, fuzziness in head, tired, weakness, sore arm
64 2021-03-12 sleep disorder I received the first dose at approximately 11:45. I had no allergic reaction. I had lunch, then went... Read more
I received the first dose at approximately 11:45. I had no allergic reaction. I had lunch, then went home. As I drove, I started getting a sparkly effect in my vision (for me, this is usually a precursor to migraine), about 2 hours after the injection. After I got home, I started getting a minor headache, about 2.5 hours after injection. I sat for awhile, and the headache did not worsen and the sparkles dissipated. About 9 hours after the injection (and after preparing and eating dinner) I began to feel lightheaded, almost a feeling of inebriation. I quickly prepared for bed and went to sleep. About 2 hours later, I woke up with diarrhea. I continued to wake up twice more, about 2-2.5 hours apart, with diarrhea. I finally slept for about 4 hours and woke up feeling better.
64 2021-03-13 feeling abnormal Last part of vaccine sent a tingling feeling down my arm to my middle finger. Once the needle was ou... Read more
Last part of vaccine sent a tingling feeling down my arm to my middle finger. Once the needle was out it stopped. Came home and iced the area once. 5:15 pm first chills started. Went away after I drank hot tea. Headache started and stayed the rest of the night until next morning. Also at 5:15 started the achy body feeling, my joints hurt. I have a total knee replacement on the right side and it ached. I had a hard time to walk up and down the steps in our house. I was suddenly real tired. Went to bed at 9:00 pm exhausted and feeling nauseated. Slept until 11:15 pm when I woke up to my teeth chattering. Put wool socks and sweater on and extra blanket. Fell back to sleep. Woke up at 7:00 am felt better, but after being up a short time I felt off. Took a nap at noon because I became real tired. Slept until 2 that afternoon (now Friday day after injection) and woke up feeling like myself. Saturday I felt fine. Sunday I woke up to a cold sore on my lip. Tender to the touch at the injection site but nothing by Sunday.
64 2021-03-14 feeling abnormal 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 2021-03-14 sleep disorder 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 2021-03-15 impaired work ability 6 hours after: chills (resolved 24 hours after dose given) 12 hours after: left upper lateral delt... Read more
6 hours after: chills (resolved 24 hours after dose given) 12 hours after: left upper lateral deltoid stiffness & ache (resolved 48 hours after dose given) 26 hours after: fatigue, mild dizziness/wooziness, mild upset stomach, mild sore throat, very runny nose (had to leave work 28 hours after dose; resolved 48 hours after dose given)
64 2021-03-15 insomnia dose 1: at 4 hours, very tender left arm and swollen upper left arm, at 12-17 hours, 101 degree feve... Read more
dose 1: at 4 hours, very tender left arm and swollen upper left arm, at 12-17 hours, 101 degree fever, stomach upset, mild chills, insomnia, at 24 hours rash on trunk, arms. Left arm remained sore to touch for additional 1.5 days. dose 2: at 2 hours sore left arm, at 9 hours lack of appetite, at 11-17 hours body aches, chills, 100 degree fever, at 22-23 hours headache, PND, sore upper left arm, at 26 hours sore upper left arm.
64 2021-03-15 insomnia My upper arm got red, hot, kind of hard and very itchy about 6 days after I got the shot. My arm ha... Read more
My upper arm got red, hot, kind of hard and very itchy about 6 days after I got the shot. My arm had hurt before that, but that?s what happens when I get a flu shot, so I didn?t think twice about it. But this itching is bad!!! It?s 6 days after the onset of the redness and itching and it?s not worse, but it?s not better either!!! I took Benadryl for two nights to help me sleep, but it doesn?t seem to have helped.
64 2021-03-15 sleep disorder extreme arm pain, sore index finger of same left arm felt like top of finger had a cut or sunburn wi... Read more
extreme arm pain, sore index finger of same left arm felt like top of finger had a cut or sunburn with nothing looking unusual in the finger , arm or injection site. Chills that night and body aches getting very bad, I couldn't sleep with lots of blankets on because I was so cold and room temp was 72 degrees, my usual. No fever. Tylenol extra strength didn't help at all. This went on 7 days. Dizzy the second day,very itchy skin, no rash, ear ache in right ear only that day. Very bad headache and photophobia for 5 days. No desire to eat or drink 6 days, but I could keep water down. Third day severe gas pains, like labor pains with lots of gas, cramps. I thought I'd faint from the pain. Nausea and dry heaves at the same time with diarrhea. I hadn't had food in 3 days or any bowel movements to this point. Felt very tired and weak. Not able to sleep, comfortably until the seventh day. Had a stiff neck. I did have a positive Covid result, asymptomatic 1 month before my first vaccine
64 2021-03-16 insomnia severe insomnia
64 2021-03-18 excessive sleepiness Tired, sweats, chills, cough, runny nose. Slept over 24 hrs. Body aches
64 2021-03-19 confusional state Moderna COVID-19 VACCINE EUA Patient stated she began to have left side weakness and confusion, Eval... Read more
Moderna COVID-19 VACCINE EUA Patient stated she began to have left side weakness and confusion, Evaluated by onsite EMS. Heart rate was 127. Transported to hospital by EMS. Spoke with patient who stated she was in ER for about two hours for observation and then went home. Feels fine now.
64 2021-03-19 disorientation Pls Note: 1st shot: 2/9/21 26 hours post 1st Moderna. * Left arm paralysis. Severe pain through upp... Read more
Pls Note: 1st shot: 2/9/21 26 hours post 1st Moderna. * Left arm paralysis. Severe pain through upper body arm. Wrists, left fingers did not function well or grip.. 99 degree fever. Chills. took antihistime and tylenol bed. symptoms alleviated by next morning. except for sore injection site and some fatique. 2nd shot 3/9/21 reaction lasted 2.5 days. 2 hrs post 2nd shot 4 pm. trouble walking, off balance, severe pain, chills, No fever, next day 3/10/21 semi conscious several hours, disoriented. tingling arms hands. Above side effects alleviated after 2.5 days NOTE: 1 week post 2nd vaccine. Arms, hands and wrists weakened. cold, tingling. weak grip bi laterally. Poor dexterity. *** :CURRENT LEFT inner elbow bone Acute burning pain. feels like neuropathy? (vaccinated arm) Onset since vaccine. -
64 2021-03-19 feeling abnormal No adverse side effect till 7days post vaccine. One seventh day woke up with severe dizziness, heada... Read more
No adverse side effect till 7days post vaccine. One seventh day woke up with severe dizziness, headache, brain fog, fatigue and periodic brain zaps. This has been ongoing since March 5, (15 days).
64 2021-03-19 sleep disorder Soreness at site that evening. Next day, weakness and soreness in arm. Three days later, 3/20, Gen... Read more
Soreness at site that evening. Next day, weakness and soreness in arm. Three days later, 3/20, General fatigue and weakness in arm returned. Awakened several times each night with sweating and feeling overly hot. Temperature normal. No medication taken for any symptoms.
64 2021-03-20 emotional distress About 14 hours after the injection I began running a high fever- the highest was 103. Along with sev... Read more
About 14 hours after the injection I began running a high fever- the highest was 103. Along with severe body shaking, chills, body aches and pain, mild headache, earache, sore throat, coughing, and loss of emotional control. Used Tylenol and ice packs for the fever and pain. Took 4 hours to get things tolerable. Early Sunday morning I only had a slight headache, sore throat and earache-which are probably due to my seasonal allergies.
64 2021-03-20 impaired work ability, feeling abnormal 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 2021-03-20 sleep disorder 5 minutes after shot shoulder pain then down to forearm. 10 minutes after shot, fast heartbeat and... Read more
5 minutes after shot shoulder pain then down to forearm. 10 minutes after shot, fast heartbeat and a little trouble breathing, headache, feel cold, stomach ache, belly ache, wanted to throw up, muscles shaking, throat sore. Drank vitamin C 1000mg. After 15 minutes I felt better. About every 15 minutes there would be another wave of the same pains. Then I would feel better and then another wave. There were five waves. After 1 1/2 hours, it stopped and I went home. Later that night, I was very thirty, couldn't sleep and my kidneys were sore. Next morning, I could not raise my arm from the pain. Every day since, I have had another wave of the same pains once in the morning and then again in the evening. Each wave lasted 1 to 2 hours. I would sleep and afterwards felt better. Saturday March 20th, the wave at night was the worst one and it lasted 3 hours. The wave today March 21st, the wave was smaller and then I could sleep. Today my arm is better, I could move it normally.
64 2021-03-21 feeling abnormal, excessive sleepiness 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 feeling abnormal I feel like I have very light prickles like a needle on my skin in one arm and then moved to the res... Read more
I feel like I have very light prickles like a needle on my skin in one arm and then moved to the rest of my body and my face. its not painful, its itchy and funny feeling that comes and goes.
64 2021-03-21 nervousness 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 2021-03-22 feeling abnormal The next day after my shot, I was debilitated. I was in bed with severe chills, nausea, headache, a... Read more
The next day after my shot, I was debilitated. I was in bed with severe chills, nausea, headache, and a sore arm. my muscles hurt all over. I have history of migraines so I have nausea medication that I used for the nausea. I took Zofran , Flexural, Ibuprofen, Promethazine, and fioricet over the course of feeling this way so I could manage the side effects. This lasted for a few days and gradually got better. the arm had a red swollen welt at the injection site and was still sore. by 03/20 I still felt bad. on03/21 I started feeling better, the welt was getting bigger and hotter, I put marks on my arm to see if it would surpass the marks, but the next day it had moved completely to a different area on my arm. it's a ways away from the injection site. (03/22) I noticed my face from the cheek/smile crease has fluids swelling up on both sides of my face but the left side is definitely worse. my face is very swollen. its itchy because I normally have rosacea. I had skin cancer on my face once that was removed and usually causes some tingling but the swelling is causing more tingling.
64 2021-03-23 anxiety About 20 minutes into her 30 minute wait period after vaccine, patient became diaphoretic and her ha... Read more
About 20 minutes into her 30 minute wait period after vaccine, patient became diaphoretic and her hands began to shake. Patient confirms she is a diabetic but states she ate a large breakfast. She was provided with juice and vital signs taken by nurse. BP-144/89 (patient states normal for her) and pulse 125 (patient states not normal). Patient states she has felt anxious and has a "couple stressful weeks". 5 minutes later, manual pulse taken- 110. 5 minutes later, manual pulse taken-100. 5 minutes later, manual pulse taken-82. Patient states she feels better and does not feel shaky anymore and believes it was her blood sugar dropping. She said she felt well enough to leave and her friend came to pick her up. She was assisted out to her car and was advised to call 911 if she experiences any later issues.
64 2021-03-23 sleep disorder No treatments initially. Big chills in the evening of March 20 and difficulty breathing, 100.7 F fev... Read more
No treatments initially. Big chills in the evening of March 20 and difficulty breathing, 100.7 F fever by morning, inability to even sit on March 21 so I stayed mostly in bed, nausea, headache, sore throat, altered taste (things tasted bitter and as chalk), strong body aches. I understand that the fever was not high, so my extreme weakness and exhaustion were not really related to the fever. Fever subsided by March 22, but numbness on the whole left side of head and body appeared for about 2 hours in the evening - unpleasant and scary, but I did not seek intervention. Headache and nausea on March 23 and 24. Total inability to sleep on the night of March 23/24 (stabbing headache and nausea contributed to a lot of anxiety). Finally took Xanax in the morning of March 24, so I finally slept between 7:30 and 10:30am. I am writing this at 3:30 pm on March 24. I am much better compared with March 21, but still with a significant headache and some nausea. I had Covid-19 in the first half of November. Post-vaccine symptoms were similar to my covid symptoms, but quick. In December I got post-covid a-fib and was diagnosed with heart failure. Improved on medication, awaiting heart ablation in May 2021. I am concerned that with the strong reaction I felt after the first dose, my reaction after the second dose may be even worse than that on March 21.
64 2021-03-24 sleep disorder Moderna covid-19 vaccine EUA right arm where the shot was given is painful and swollen, worse the da... Read more
Moderna covid-19 vaccine EUA right arm where the shot was given is painful and swollen, worse the day after. could not sleep because of it hurting. Is this normal? My husband got his vaccine shot at the same time and it did not do this to him.
64 2021-03-24 sleep disorder High fever, body aches, cough, chest pressure, dizziness, lack of energy, lack of sleep, headache
64 2021-03-25 confusional state Possible adverse event. Temporary and quick onset confusion, couldn't find way home from walk.
64 2021-03-25 depression 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 feeling abnormal right away there was pain in the knee, Chills the following day- wearing layers of clothes and still... Read more
right away there was pain in the knee, Chills the following day- wearing layers of clothes and still cold, fatigue, weird sensation and aches in arms and legs, under the weather similar to the flu, headache,
64 2021-03-25 panic attack 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 2021-03-26 feeling abnormal About 45 minutes after receiving vaccine in right arm the right side of my face became tingly and nu... Read more
About 45 minutes after receiving vaccine in right arm the right side of my face became tingly and numb. Starting with my chin and going to the forehead and across to the right ear. That feeling started to dissappear around 2 pm and I was left with a headache, mild nausea, and an uncomfortable feeling in my right eye. The next day I had a slight headache and the right eye still feels uncomfortable.
64 2021-03-27 feeling abnormal One week after 1 shot, I aquired a raging headache, bad body aches, chills, fatique NO temp, No cou... Read more
One week after 1 shot, I aquired a raging headache, bad body aches, chills, fatique NO temp, No cough, I'm on day 6 of feeling poorly with raging headache.
64 2021-03-27 sleep disorder Started with arm pain after 3 hours which got worse than last shot which was only arm pain. Then few... Read more
Started with arm pain after 3 hours which got worse than last shot which was only arm pain. Then few hours later bad body aches felt like bad pain in my bones all over and chills couldn't get warm I noy slept 1 hour even after the Tylenol because hurt so bad all night, didn't take temp hurt to move. All day Friday feverish ranging from 99-102. I normally run cold took temp Thursday morning 96.7. Saturday fever down to 97.5 but felt woozy, tired, weak all day felt hungry again. Sunday today woke up at 5am metallic taste in mouth temp 96.2 and felt a bit chilled. Also last two nights tickling cough but that could be allergies again
64 2021-03-28 sleep disorder Fever, nausea, headache, bodyaches, tiredness, lack of sleep, cough, nasal stuffyness, sore throat
64 2021-03-29 excessive sleepiness Sweats, chills, lower back pain, weak, sleeping all day, diarrhea, feverish feeling in left arm.
64 2021-03-29 loss of personal independence in daily activities Pt developed headache the day following the vaccine. It was severe the first week, limiting daily a... Read more
Pt developed headache the day following the vaccine. It was severe the first week, limiting daily activities but then became more mild but lasted 4 weeks.
64 2021-03-31 agitation Severe fatigue throughout day 3/22-3/26/21, I gave myself time to rest Severely agitated mood and sh... Read more
Severe fatigue throughout day 3/22-3/26/21, I gave myself time to rest Severely agitated mood and short tempered throughout the day, stay isolated interactions with people at home, 3/24-3/26/21
64 2021-03-31 emotional distress, feeling abnormal arm swollen up; red pinkish all to elbow; she couldn't move, talk, reach her arm AND head, leg and b... Read more
arm swollen up; red pinkish all to elbow; she couldn't move, talk, reach her arm AND head, leg and body not working; no control of her body; had no feeling in her body; pee in her pants; mouth was hanging open, couldn't move; horrifying; so ill; "i'm going to hit myself"; not felt good; chills; fever; A spontaneous report was received from a consumer concerning a 64 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypotonia, mental distress, hypoesthesia, malaise, dyskinesia, feeling bad, arm swelling, chills, fever and arm erythema. The patient's medical history was not provided. Concomitant product use was not provided. On 14-Mar-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 in the left arm for prophylaxis of COVID-19 infection. On 14-Mar-2021, patients had fever and chills. On 15-MAR-2021, she was so ill, lost all function of her body, she could not move, talk, reach her arm. She thought she was going to die. She did not felt good, went to bed and 5 minutes later she thought she was going to hit herself because she had no control of her body, her head in the bead, she pee in her pants. Her mouth was hanging open, could not move. The patient mentioned her head, leg and body not working, had no control of her body, she described the situation horrifying, so close to death, had no feeling in her body. Se did not want to go to the ER.. Husband stayed with her and she improved 3 hours later without treatment. On the next day, they contacted her physician who prescribed over the counter treatment. Laboratory test were not reported. Treatment included Benadryl, Advil and 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 is not applicable. The outcome of the events, hypotonia, mental distress, hypoesthesia, malaise, dyskinesia, feeling bad, arm swelling, chills, fever and arm erythema 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.
64 2021-03-31 feeling abnormal My throat was a little scratchy during the 20 minute wait. Didn?t give it to much concern as not muc... Read more
My throat was a little scratchy during the 20 minute wait. Didn?t give it to much concern as not much reaction after first shot. When I got home And approximately 35 minutes my left side of face and behind my ear started to tingle, or buzz or felt strange when touching it. Returned to normal after about a total of 60 minutes. Next day noticed a heightened awareness on my left leg below knee like it was super sensitive. This is still going occurring. Today 4/1 also had sensation on outer thigh of left leg. Left arm the sensation feels like flushed skin or heat. Leg at time also.
64 2021-03-31 sleep disorder Deep ache in arm began 4 days after injection. Keep patient awake at night for several nights. Fel... Read more
Deep ache in arm began 4 days after injection. Keep patient awake at night for several nights. Felt like the feeling after hitting the funny bone - whole arm was affected. Began to ease up 6 days after injection
64 2021-03-31 sleep disorder After 5 min of receiving shot, in right arm, my right lung began to feel painful. When I am in an ... Read more
After 5 min of receiving shot, in right arm, my right lung began to feel painful. When I am in an environment (house) with someone that has dogs/cats, I will have this same feeling.. allergic reaction to the animal dander. This happens if I am in the environment more than 2 hours, and after leaving the environment, the reaction dissipates from 2 to 6 hours later. The reaction I had after receiving the shot was the same as above. Also, during sleep, my Left lung at times feels a crushing sensation.. it dissipates once I lay flat on bed for a minute or two. The sensations continue to this day, the pain if felt from front to the back of my lungs.
64 2021-03-31 sleep disorder In the late evening after receiving the vaccine, my left arm started to hurt profusely. The pain em... Read more
In the late evening after receiving the vaccine, my left arm started to hurt profusely. The pain emanated from the arm joints; the shoulder, elbow and wrist joints. The pain grew worse and worse overnight until I could not sleep. By the next day, my arm hurt so much it felt as if it had been broken. I had to put my arm in a sling so as not to move it. I called my doctor and was advised to take 800 mg of Ibuprofin and 1000 mg of Tylenol throughout the day for 5 days. I took both as prescribed and over time my arm felt better. Today is day 16 after having the vaccine. Yesterday was the first day I did not take the pain relievers and my shoulder joint still hurts a lot. When will this pain end?! I guess I'm back to taking pain relievers.
64 2021-04-01 sleep disorder, anxiety I had ringing in my ears, bilateral headache, chills and sweats, no appetite with nausea, my urine w... Read more
I had ringing in my ears, bilateral headache, chills and sweats, no appetite with nausea, my urine was brown on two occasions, my mouth is dry, I was anxious especially at night, I was unable to sleep for very long. And I was very weak and exhausted. I am only feeling a little better today.
64 2021-04-02 feeling abnormal 1st and 2nd day pressure headache & a bit foggy then aches in neck and shoulders. 3rd day severe a... Read more
1st and 2nd day pressure headache & a bit foggy then aches in neck and shoulders. 3rd day severe abdominal cramps, bloating, gas, fatigue. 4th day severe abdominal cramps, bloating, gas, temperature 100.9, headache, fatigue. 5th day abdominal cramps (not as severe), fatigue, low fever. 6th day fatigue, slight abdominal cramps, occasional diarrhea. Hoping my 7th day I will be back to normal. The severe abdominal cramps were the worst I have ever experienced, if I wasn't 64, I would of thought I was delivering a baby, it was horrendous.
64 2021-04-03 anxiety Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient described feeling anxious, gav... Read more
Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient described feeling anxious, gave her gatorade and had her lie down intially for a while then sit down until someone came to pick herup
64 2021-04-03 anxiety Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient displayed anxiousness.. gave h... Read more
Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient displayed anxiousness.. gave her gatorade, she laid down then sat down until she felt better
64 2021-04-03 disturbance in attention, sleep disorder DOSE #1 After about an hour, my face was flushed and arm sore, of course. Later 1st day an... Read more
DOSE #1 After about an hour, my face was flushed and arm sore, of course. Later 1st day and for next 5 days, EXTREMELY fatigued and tired; VERY hard to concentrate. Sinuses felt a bit congested during this time. Also had difficulty staying asleep first 3 nights after injection. Tiredness and fatigue took approx. 2 1/2 weeks to resolve completely. After 2nd day I began to experience joint pain and swelling, including elbow and knee. I do not normally have any problems with this. I could barely bend my knee. These symptoms lasted over a week. During this time I also had episodes of mild dizziness and nausea, but nothing that hindered my daily activities. Redness at injection site, which at one point was 4 - 5 inches in diameter, lasted approx. 2 1/2 weeks before it completely disappeared. DOSE #2 (03/30/2021) No problem sleeping after 2nd dose. Much more pain/redness at injection site. Again, experiencing extreme fatigue, feeling exhausted, difficulty concentrating. This time joint pain/swelling is minor. With the 2nd dose, I also am experiencing swollen lymph nodes (left side, underarm), and a odd taste in my mouth 24/7. I expect this too will resolve after a few weeks. In addition to the allergies listed on page one, I do have many other allergies and sensitivities (too many to list on this form). I cannot have wine due to sulfites, processed meat due to nitrites and nitrates, I stay away from most processed food, am allergic to cats and dogs, and have severe reactions to wasp/bee/bug stings and/or bites. Last year I was stung by a wasp on my ear and hand. The complications of extreme swelling, pain, dizziness, nausea, swollen lymph nodes in my neck/throat area, took more than a month to resolve. I can not eat or drink anything with artificial sweetener. The list goes on... So, I am not surprised I reacted like I did to the vaccine. However, I was grateful to have this vaccine and feel fortunate to have had the opportunity. Thank you and have a wonderful day!
64 2021-04-03 feeling 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 2021-04-03 impaired work ability, feeling abnormal, excessive sleepiness Felt bad like I was coming down with something. Got cold just wanted to lay down and cover up. At 11... Read more
Felt bad like I was coming down with something. Got cold just wanted to lay down and cover up. At 11:30 P.M. I got very cold and I began to shake. I had a fever of 100.1 so I took 2 tylenol and went to bed. I dont know if my fever would have gone higher but didnt want to find out so I took the tylenol. I felt bad all day April 1, 2021. I didnt go to work and slept off and on all day. I felt a little sick to my stomach but no throwing up . I finally felt myself late the evening of April 1. What was strange to me was the sudden shaking.
64 2021-04-03 sleep disorder Swollen with a red rash, on injection arm ....itchy, painful to touch or sleep on. Large visible lu... Read more
Swollen with a red rash, on injection arm ....itchy, painful to touch or sleep on. Large visible lump. It moved down arm to my left thigh. Lasted a week or more.
64 2021-04-04 feeling abnormal On sunday april 4th at @ 1am woke up to burning itching large red blotches on thighs arms and left s... Read more
On sunday april 4th at @ 1am woke up to burning itching large red blotches on thighs arms and left side of rib area and also right palm of hand. Took benadryl tablet and applied benadry cream on the spots affected. After about an hr was able to get to sleep. When I got up next morning the redness was gone but still felt itchy and weird. Today its still feels weird and I have redness and itchiness on elbow of right arm.
64 2021-04-04 feeling abnormal 2 weeks after the shot I got a rash on my arm and severe diarrhea. Severe cramping and lots of blood... Read more
2 weeks after the shot I got a rash on my arm and severe diarrhea. Severe cramping and lots of blood. I went to the ER and was told I had colitis. Right after the shot I felt out of it. Also felt like I had a mild case of the flu.
64 2021-04-05 feeling abnormal, amnesia Moderna COVID-19 Vaccine EUA Fatigue and brain fog starting 24 hours after injection; muscle pain an... Read more
Moderna COVID-19 Vaccine EUA Fatigue and brain fog starting 24 hours after injection; muscle pain and "grating" shoulder in the arm, "Covid Arm". After about 72 hours the physical symptoms were negligible (other than the Covid Arm rash), but I began having serious trouble with my short term memory. I could not remember things I'd been told or done just a few minutes before - or, rather, I knew I did them, but I could not remember specifics like the name of the food I had ordered or what the actual order was. I could not tell a salesperson in what I needed, what it was called specifically. (Thankfully I had a list to give him.) I planted a flowerbed and then could not remember what I had planted. Five minutes later I knew I had planted a flower bed, but could not remember which of the two beds it was OR what I'd planted. That sort of thing. I am having hell naming things - if it's got a proper name, I'm really struggling to find it. Nouns. I received the second vaccine on Thursday night and this started on Monday, and today is Tuesday (I think) and it's still going on.
64 2021-04-05 mental status changes, confusional state 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 sleep disorder 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 2021-04-06 anxiety Patient received vaccine and became light headed and dizzy within 10 minutes, patient was relocated... Read more
Patient received vaccine and became light headed and dizzy within 10 minutes, patient was relocated to a cot and placed supine. Patients blood pressure was taken and was noted to have a systolic pressure of 186. After approximately 10 minutes another blood pressure was taken with a systolic over 200. Patient began feeling shivers and heightened anxiety. Following additional assessments patient was advised of seeking medical attention and stated that she would have herself privately transported to a local hospital for assessment. Following approximately 10-15 minutes, patient was noted to have a drop in blood pressure of about 15 points but still decided on seeking medical attention. Patient was picked up by her husband and transported to a local hospital.
64 2021-04-07 nervousness 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 2021-04-08 anxiety 65 y.o. female who presents with possible stroke-like symptoms. Patient reports a prior history of ... Read more
65 y.o. female who presents with possible stroke-like symptoms. Patient reports a prior history of a CVA approximately 6 months ago. Patient states she has been left with some mild decreased grip strength in the right hand due to that stroke. Patient reports she went to bed feeling weak and fatigued last night. She reports she woke up at 3:00 a.m. and noticed her lips were numb and tingly. She stated she then noticed her right hand was slightly tingly as well. She states she went into the bathroom and looked at herself in the mirror. She did not observe any facial droop or slurring of her speech. Patient denies any headache, chest pain, or palpitations. Patient reports her symptoms are improving. Her right hand tingling has resolved and the numbness and tingling to her lips are much better. Patient does report she has been under a lot of stress and worry lately. She is uncertain that the symptoms are stroke related or due to stress and anxiety.
64 2021-04-08 insomnia 4/7 6pm arm very sore fevered, caused sleepless night, 4/8 headache, body aches, low grade fever, c... Read more
4/7 6pm arm very sore fevered, caused sleepless night, 4/8 headache, body aches, low grade fever, chills, nausea
64 2021-04-08 nervousness 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 2021-04-08 sleep disorder, impaired work ability Headache and fever started about 1/2 hour after injection. It has been 7 days and I still have a ver... Read more
Headache and fever started about 1/2 hour after injection. It has been 7 days and I still have a very bad headache and sometimes fever up to 99.9. I do get some relief if I take Tylenol every 6 hours but at night when I try to sleep is the worst. My head pounds so hard it keeps me up. I also can see a pulse when I close my eyes. I have never had a headache that lasts this long or this intense. I stayed home in bed for the first 5 days but had to return to work on 4-8-21. I cannot take much more of this headache, it is wearing me down.
64 2021-04-09 feeling abnormal Intense headache, extremely tired was unable to function on day following injection, no energy, sle... Read more
Intense headache, extremely tired was unable to function on day following injection, no energy, slept all day and don't ever sleep during the day. Foggy feeling, Headache lasted 4 days.
64 2021-04-10 feeling abnormal Tasted vaccine in throat, throat closed briefly, ringing in ears began immediately, hearing loss/stu... Read more
Tasted vaccine in throat, throat closed briefly, ringing in ears began immediately, hearing loss/stuffiness in right ear occurred immediately, foggy brain occurred immediately. The tinnitus is constant and persists along with the hearing loss .
64 2021-04-10 excessive sleepiness Hurting all over ,chills & fever , horrible pain Couldn't move. For 2 days 3rd day hurting but cou... Read more
Hurting all over ,chills & fever , horrible pain Couldn't move. For 2 days 3rd day hurting but could get out of bed 4th day asleep 18 hours
64 2021-04-10 impaired work ability, feeling abnormal woke up early weds morning, with room spinning. crawled to the bathroom, and vomited. missed work ... Read more
woke up early weds morning, with room spinning. crawled to the bathroom, and vomited. missed work as spent day in dark room, hard to move my head. no more 'vertigo' affects, but left with continuous 'foggy head' and fatigue
64 2021-04-10 sleep disorder, disturbance in attention Nurse cautioned that some people have a reaction to the second does and to minimize the reaction I c... Read more
Nurse cautioned that some people have a reaction to the second does and to minimize the reaction I could take a tylenol in 6 hours. I had my shot at 8:55 am, so I took a 325 mg tylenol at 3 pm on the day of my shot. My arm got sore but not too bad. I went to bed at my regular time of 10 pm. I woke up at 1 am on Saturday. I was shaking from chills, my teeth hurt from my teeth chattering. I could not get warm. I got up and checked the thermostat to see if I needed to turn up the heat, it was 74 degrees. I checked my temperature it was only 99. 6 degrees. I went and got another blanket and it took another 3 hours for my shaking to quit. I didn't sleep the rest of the night I was too hot or too cold. I finally gave up and got dressed at 6 am. The rest of day I was running a low grade fever. My jaws hurt from all the chattering they did earlier. I had a headache bordering on a migraine all day. I took a short nap but still felt drugged out. I couldn't think good. I was physically hot to the touch but still just had a low grade fever. I went to bed early at 9 pm. I took two antihistamine in order to sleep. I woke up at 6 am this morning. The fever had broken,, all my clothes were wet, I had to chang them. I fell much better this morning.
64 2021-04-11 disturbance in attention This shot was at a drive through site. This was my 2nd CoVid vaccine. I likely had a severe case o... Read more
This shot was at a drive through site. This was my 2nd CoVid vaccine. I likely had a severe case of Covid July 2020 with primarily GI symptoms. The 1st shot my right arm was sore for 4 days and I felt under the weather. 2nd shot by that evening felt dizzy and went to bed. Woke up the next morning with extreme nausea and vomiting, not aware of dizziness. Vomited at least 7 times in the first 5 hours of the day. unable to keep a sip of water down. Vomiting and nausea persisted into day 2. Day 3 dizziness began, able to eat lightly. Couldn't keep my head up. Had to stay prone or would faint. Day 4 slightly better but very foggy, lightheaded and dizzy if moved head. I am on Day 6 now, feel like I have drunk too much alcohol. Can walk but focus is difficult and have disequalibrium. Ears feel full and popping, tinnitus is much worse. Cannot (should not) drive or exercise outside - can do stationary bike which I started Day 4.
64 2021-04-11 sensation of foreign body, anxiety Patient reported having a lump in her throat and feeling anxious Patient seen by medical team and vi... Read more
Patient reported having a lump in her throat and feeling anxious Patient seen by medical team and vitals were stable Patient refused medical transfer and signed AMA form Patient stated symptoms improved
64 2021-04-11 sleep disorder 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 nervousness Patient started to feel shaky, hot and had trouble breathing about 10 minutes after receiving the va... Read more
Patient started to feel shaky, hot and had trouble breathing about 10 minutes after receiving the vaccine. Patient was given 50mg of diphenhydramine and one epi-pen and 911 was called. EMS arrived about 15 minutes after the reaction began. They monitored the patient, checked her blood pressure, heart rate and pulse ox. The patient has began to recover at this time and EMS released her. The patient's son was present the entire time.
64 2021-04-13 fear abscess/mass in her intestine; lower abdominal pain; Terrified to receive the 2nd dose; itching; Pos... Read more
abscess/mass in her intestine; lower abdominal pain; Terrified to receive the 2nd dose; itching; Postponed 2nd dose of the vaccine; urticaria (Hives) all over her body.; This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS INTESTINAL (abscess/mass in her intestine) 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 No adverse event (No reported medical history). On 25-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 URTICARIA (urticaria (Hives) all over her body.). On 25-Mar-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Postponed 2nd dose of the vaccine). On 01-Apr-2021, the patient experienced PRURITUS (itching). On an unknown date, the patient experienced ABSCESS INTESTINAL (abscess/mass in her intestine) (seriousness criteria hospitalization and medically significant), ABDOMINAL PAIN LOWER (lower abdominal pain) and FEAR (Terrified to receive the 2nd dose). On 25-Mar-2021, INCOMPLETE COURSE OF VACCINATION (Postponed 2nd dose of the vaccine) had resolved. At the time of the report, ABSCESS INTESTINAL (abscess/mass in her intestine), ABDOMINAL PAIN LOWER (lower abdominal pain) and URTICARIA (urticaria (Hives) all over her body.) had not resolved and PRURITUS (itching) and FEAR (Terrified to receive the 2nd dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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.
64 2021-04-13 feeling abnormal Fatique 2 days (Saturday and Sunday following vaccine on Friday) but Monday had feelings described a... Read more
Fatique 2 days (Saturday and Sunday following vaccine on Friday) but Monday had feelings described as "wierd", blurry vision, brain fog, eyes seemed to wander, super tired, eyes seemed to move back and forth, felt strange, disconnected, just not right. These symptoms are continuing through today 4/14/21 - 5 days later. When asked if better than yesterday she stated "Maybe a little"
64 2021-04-14 feeling abnormal Information Provided by Patient's Husband Received vaccine on April 6th. April 7th: nausea and vomit... Read more
Information Provided by Patient's Husband Received vaccine on April 6th. April 7th: nausea and vomiting all day April 8th: fatigue, slept all day, hardly ate, mental fog when awake. April 9th: Slept 22 hours, didn't respond well to attempts to wake her up, mental fog when awake April 10th: ambulance took patient to local hospital where patient was admitted April 13th: Discharged from hospital. Mental fog and fatigue still continuing. Husband states that mental fog seems a little worse this morning April 15th.
64 2021-04-14 feeling abnormal No pain at injection site. 4 hours post injection pain in armpit and left breast severe. Pain lasted... Read more
No pain at injection site. 4 hours post injection pain in armpit and left breast severe. Pain lasted 2 weeks. The day after the injection extremely tired, body felt out of sorts.
64 2021-04-15 excessive sleepiness, insomnia COVID POSITIVE 10/23/2020. MILD SYMPTOMS. TESTED WEEKLY AT WORK. LOSS OF TASTE NEXT DAY WITH EYE ... Read more
COVID POSITIVE 10/23/2020. MILD SYMPTOMS. TESTED WEEKLY AT WORK. LOSS OF TASTE NEXT DAY WITH EYE IRRITATION. COVID ANTIBODY TESTING ALL NEGATIVE: 4/30/20, 6/17/20, 11/18/2020, 12/22/2020, 4/1/2021 MODERNA VACCINE DOSE NUMBER 1: 3/13/2021 MODERNA VACCINE DOSE NUMBER 2: 4/10/2021 1:15PM 4/10/2021 9PM: INTENSE NAUSEA WITHOUT VOMITING. RIGHT ARM PAIN INCREASING WITH LOWER BACK PAIN. ROPINEROL IN EVENING 0.5MG X 2 4/11/2021 ALL DAY: SLEPT MOST OF DAY, FATIGUE, SOME NAUSEA, LOW BACK PAIN WORSE, OVER ALL FATIGUE. PLACED LIDOCAINE 3% PATCH ON LOWER BACK WHICH HELPED WITH LOW BACK PAIN. CONTINUE TO WITH OTHER BONE PAIN, FATIGUE, RIGHT ARM PAIN. 4/12/2021: SAME AS PREVIOUS DAY. 4/12/2021: 5PM, FATIGUE RESOLVED, BACK PAIN COMPLETELY RESOLVED. TOOK ROPINEROL IN EVENING 1MG 4/12/2021: Monday: I took Ropineral 0.5mg at 5:30pm. The RLS symptoms were worse, and incredibly intense. This is the worst it has ever been. ------------ BODY CHANGES: RLS worsened more than I've ever had experienced. I carry the genetic variables connected to AMLD/RLD. Symptoms usually worsen mildly 30 minutes after taking Ropineral 0.5mg. I will usually wait for this augmentation, then 2 hours later i will take a second dose or ropineral. The RLS was in my hips, thighs, legs. (normally they are in the lower extremities). This felt out of control where I wasn't able to sit at all. my lower extremities felt like I was having vascular changes, almost a tingling, decrease blood flow. No pain. I wear compression knee highs while working. The RLS continues through the night until around 11:30pm. First dose aroun 6pm. Second dose usually around 9pm. the RLS got progressively worse with each ropinerol I took. RLS symptoms with decreased sleep have progressively gotten worse with each day. Starts after taking the first ropinirole dose. Then worsens after taking second dose. It makes it nearly impossible to sleep. I have never experienced th worsening of these symptoms of this. a dramatic difference. Ropinerol is now making it worse, but I can''t sleep without it.
64 2021-04-15 loss of personal independence in daily activities Chill , fever aches,pain,headache,weak joint pain numbness in feet could hold my eyes open and stay... Read more
Chill , fever aches,pain,headache,weak joint pain numbness in feet could hold my eyes open and stayed in bed 2 days couldn?t do anything except use bathroom taste off 3D day weak but up short periods diarrhea (hope tomorrow better)
64 2021-04-15 mental status changes 7 days after vaccination, patient developed facial swelling, itching, redness, sciatica, and mental ... Read more
7 days after vaccination, patient developed facial swelling, itching, redness, sciatica, and mental change that lasted approximately 2 weeks. The only treatment used was Benadryl.
64 2021-04-15 nervousness, feeling abnormal pt says she was very fatigued so she laid down. She woke up nauseated, weak, she had chills, headac... Read more
pt says she was very fatigued so she laid down. She woke up nauseated, weak, she had chills, headache, loss of appetite, feverish, very nervous. She was not able to use her cell phone. She felt like she was dying. She called her PCP that is from out of town on 4/16/21. He told her to seek medical help if her symptoms became any worse.
64 2021-04-16 excessive sleepiness, feeling abnormal I was ill for 3 days and could not get out of bed. For the first 24 hours after my shot, I was extr... Read more
I was ill for 3 days and could not get out of bed. For the first 24 hours after my shot, I was extremely nauseous (I eventually vomited which helped). I was running a temperature. I felt light headed when I tried to get out of bed. For the next 24 hours, I ran a temperature, had an extreme headache, had an ear ache in my right ear and my right sinus hurt. Again, I could not get out of bed. After around 48 hours, the fever broke, but I still felt like I had an extreme migraine, my right sinus hurt and my right ear hurt. Light hurt my eyes. I spent 72 hour sleeping. I drank hot tea and ate a little soup during this time, but that was all. I felt HORRID for three full days. This was MUCH longer than I expected. If you decide we need booster shots, I hope you figure out what was making me feel so horrible. I can't imagine going through this for three days every time I get a booster. Thank you for making the vaccine. I do feel like it will protect me.
64 2021-04-16 insomnia 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 sleep disorder Flu symptoms: Cold chills, sweaty, body aches, no appetite, painful enough to not sleep, extremely t... Read more
Flu symptoms: Cold chills, sweaty, body aches, no appetite, painful enough to not sleep, extremely tired, headache, no nausea.
64 2021-04-18 abnormal dreams Started with sore arm where I could not raise it. (12pm) Headache, fever, chills (2pm) Light headed,... Read more
Started with sore arm where I could not raise it. (12pm) Headache, fever, chills (2pm) Light headed, fatigued, swollen joints in fingers (I have arthritis), could make a fist (6pm) called off from work at 8pm Had very vivid weird dreams, breathing somewhat labored, woke up every hour. I took Excedrine Severe Headache every 4 to 6 hours, drank lots of fluids Woke up in a pool of sweat, showered, changed went back to bed. Friday same thing, I pretty much stayed in bed all day. I did not start to feel better until late Saturday afternoon around 2pm and then I developed a rash on my left inside of arm and left side of my waist. It is very itchy and I have been putting hydrocortisone on as needed. I still have the rash, and feel pretty good. Will be contacting my Drs. office today.
64 2021-04-19 mental status changes Patient claims to have experienced muscle pain (sore arm), arm swelling and redness, fever (102.5 -1... Read more
Patient claims to have experienced muscle pain (sore arm), arm swelling and redness, fever (102.5 -103 F), rash, shaking, atrophy, altered mental status, shortness of breath, nausea, vomiting, diarrhea, and altered taste.
64 2021-04-20 anxiety Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . Duri... Read more
Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: dizziness and dry mouth. Assessment : Time of assessment 10:54. Alert and oriented, Anxious and Felt wobbly, headache. Completed observation period of 30 minutes, stood up to go home, felt dizzy, dry mouth, wobbly 1054 BP 128/85 pulse 99; 1102 BP 139/80 Pulse 93, taken from observation area Via w/c to stretcher in hall way, given water, continues to feel dizzy 1110BP 143/96 Pulse 91 pulse ox 98, 1118 Complaints of headache BP 144/101 Pulse 89 pulse ox 98 , 1124 EMS called continues to feel dizzy with headache, 1137 EMS arrived BP 143/84 pulse ox 96 1141 Complaints of severe headache dizziness BP 135/84, sitting BP 149/92 pulse 96 pulse ox 97 became dizzy standing for BP unable to complete. 1145 am transported to ER per patient request via EMS, purse given to mother Actions taken: Vitals sign taken EMS called at 1124. VAERS form obtained and completed Hand off to EMS upon arrival at 1137. There were no vitals filed for this visit. Medications administered: No medication administered. Disposition:Patient evaluated and transferred to the hospital for further evaluation and care. Time of transport: 1145.
64 2021-04-20 anxiety Lightheaded, anxious
64 2021-04-20 feeling abnormal 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 feeling abnormal 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 2021-04-20 feeling abnormal Dose #1: Sore arm at site of injection for 2 days Dose #2: Night 1 - Intense whole body ache, low... Read more
Dose #1: Sore arm at site of injection for 2 days Dose #2: Night 1 - Intense whole body ache, low fever, unsteady on feet through the night accompanied by brain fog. Day 2 - Fatigued, sluggish. Day 3 - Return to normal energy. Day 8 - Rash on belly (small rough bumps similar to when I eat gluten), spreading to back. Day 9 - Red splotches developed on R breast (1, then 2, then 3); hard nodules formed after a few hours. Another red splotch developed close to armpit, perhaps lymph node? in the evening. Soreness with this splotch. Day 10 - L sore wrist that intensified with finger/hand movement. Pain spread to elbow. Swelling followed at wrist and hand. Ibuprofen and ice eventually reduced. Took over 24 hours to resolve. Day 11 - Red splotches appeared on L breast. Day 15 - Dr. visit. No diagnosis. Unknown if related to vaccination. Perhaps all separate signs & symptoms? Staph? Day 17 - Brain fog returned throughout the day; overall low energy. Day 18 - One new red splotch on R breast.
64 2021-04-20 sleep disorder, impaired work ability I WAS NOT EXPECTING SYMPTOMS WITH THE FIRST SHOT, WAS TOLD IT "NORMALLY" DIDN'T HAPPEN, BUT TO EXPEC... Read more
I WAS NOT EXPECTING SYMPTOMS WITH THE FIRST SHOT, WAS TOLD IT "NORMALLY" DIDN'T HAPPEN, BUT TO EXPECT SYMTOMS WITH 2ND DOSE. I WENT BED FEELING FINE, WOKE UP ABOUT MIDNIGHT WITH BODY ACHES IN EVERY PART OF MY BODY, CHILLS, FEVER, NAUSEA. ARM IS VERY SORE, NOT EXPECTING THAT MUCH PAIN AT INJECTION SITE. I AM NOT ABLE TO WORK TODAY WITH THESE SYMTOMS WHICH HAVE SUBSIDED A LITTLE BIT, BUT NOT MUCH.
64 2021-04-20 sleep disorder 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 2021-04-21 anxiety 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 feeling abnormal Patient presented for her second COVID vaccine on 04/21/21 and described events following her first ... Read more
Patient presented for her second COVID vaccine on 04/21/21 and described events following her first vaccine on 03/24/21. She reported that about 30 minutes after her vaccine she felt the vaccine "moving through her arm". She stated her left arm, hand, and fingers were tingling all the way up to her neck. She did not feel short of breath but did report that her tongue felt "thick". She also reported that her brain was "foggy" and she had a metallic taste in her mouth. These sensations lasted throughout the day and evening and she was "fine" the next day. She did not discuss any of her symptoms with a doctor. She states she had hesitations about getting the second vaccine. We discussed that due to her side effects we would not recommend getting the second vaccine at this time and that she could discuss further with her primary care if needed. She was agreeable to this.
64 2021-04-22 confusional state 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 2021-04-22 feeling abnormal Day after had a fever, chills, extremely tired and generally didn't feel good; arm was sore, warm, h... Read more
Day after had a fever, chills, extremely tired and generally didn't feel good; arm was sore, warm, hard, and rashy; the following day had a headache that went away in the afternoon; took tylenol as was recommended at the time of the vaccine if I had any adverse symptoms ( I am usually an advil person )
64 2021-04-22 feeling abnormal Fever/ chills and crashing headache that could not be alleviated by NSAIDs. Dry heaves for 14 hrs. o... Read more
Fever/ chills and crashing headache that could not be alleviated by NSAIDs. Dry heaves for 14 hrs. occasional floating feeling. Soreness in arm that migrated to shoulder muscles and back severe enough to be felt when breathing. Fatigue.
64 2021-04-23 impaired work ability 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 sleep disorder 4 days of a stiff and immovable neck, sore lymph nodes in neck, base of skull & clavicle bone, swol... Read more
4 days of a stiff and immovable neck, sore lymph nodes in neck, base of skull & clavicle bone, swollen throat with difficulty swallowing, unable to sleep for 3 nights!
64 2021-04-24 disturbance in attention Moderna COVID-19 Vaccine EUA symptoms for approximately 18 hours: Chills and fever of 100.1 degrees ... Read more
Moderna COVID-19 Vaccine EUA symptoms for approximately 18 hours: Chills and fever of 100.1 degrees F Headache like a vise grip causing brain fog (lack of concentration) Lack of appetite
64 2021-04-24 loss of personal independence in daily activities Extreme fatigue lasting more than 1 week, headache for several days, back pain, abdominal pain, join... Read more
Extreme fatigue lasting more than 1 week, headache for several days, back pain, abdominal pain, joint pain so bad it was hard to get dressed, urinary tract infection (about 36 hours later)
64 2021-04-25 disturbance in attention Hands numb right and left, and pain thru right hand center; hand veins bulge; Extreme allergic skin ... Read more
Hands numb right and left, and pain thru right hand center; hand veins bulge; Extreme allergic skin rash on hands thru wrist; Entire body swollen; Extreme headache, eyeache and dizziness; Fever of 99.6 (96 degrees normal on thermometer I have); Every old injury site reactivated--could not put weight on right hip and ankle/foot pain, back pain; Appeared to activate neurologic injuries negatively. Extreme pain, inability to concentrate, sore throat. VERY weak. Could not grasp with right hand--too swollen to hold a cup. Strange dreams and old memories surfaced. Face had flushed red immediately after shot, but severe reaction the next morning. Afraid of further swelling to do shot #1 - 8th day arm swelling and heat. Left arm still bruised from shot # 1. Just tired and slight reactions after the bad day of 4/23. Symptoms subsiding.
64 2021-04-25 insomnia fever, diarrhea first night. then following week, extreme headaches, very stiff neck. Could not sl... Read more
fever, diarrhea first night. then following week, extreme headaches, very stiff neck. Could not sleep, leg weakness. 8 days later, patient went to ER. Foot numbness.
64 2021-04-27 loss of personal independence in daily activities Woke up at 3:15 a.m. shivering and feeling feverish. Within 15 minutes, I started vomiting. 20 minut... Read more
Woke up at 3:15 a.m. shivering and feeling feverish. Within 15 minutes, I started vomiting. 20 minutes after that, I also had diarrhea. I felt very weak and achy. My arm hurt more than it did with the fist dose, tho by moving it around, it got better. After about 8 hours, the nausea and diarrhea pretty much subsided but I still felt very weak, I couldn't do anything but lay on the couch. The fever lasted until about 9:00 p.m. when it broke and went from 104.2 to 101.5. The next day I was still weak but only running a very low grade fever and able to move around and eat.
64 2021-04-28 feeling abnormal 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 impaired work ability, loss of personal independence in daily activities Began to experience constant exhaustion and dizziness 2 days after receiving the 2nd dose of the vac... Read more
Began to experience constant exhaustion and dizziness 2 days after receiving the 2nd dose of the vaccine. Daily life is difficult and been unable to return to work due to the effects of the vaccine. The symptoms persist as of the writing of this report.
64 2021-05-03 feeling abnormal, impaired work ability April 6th, at approximately 10:55am, I received a Moderna Covid-19 vaccination at clinic. After the... Read more
April 6th, at approximately 10:55am, I received a Moderna Covid-19 vaccination at clinic. After the vaccination, I felt fine; no side effects for about 5 hours. At approximately 4:30pm, I got the chills, body, muscles and back aches, fever - 101.2, sore throat, my eye balls hurt and a sore scalp. All of these effects came one like a wave. My entire body ached and I felt as though I was run over by a steam roller. I took Tylenol, 500mg at 5:30am and the next day, April 7th at 11:30am and still had a fever. My entire body was in pain and discomfort and I could barely move and was unable to work for 4 days and laid up on the weekend. To-date, I am still feeling tired, achy and lethargic.
64 2021-05-06 feeling abnormal patient states she had nasuea, vomiting and headache that night of the vaccine. The next day she sai... Read more
patient states she had nasuea, vomiting and headache that night of the vaccine. The next day she said she felt achey all over her body and felt bad. Today at day 10 she said her arm is red, has a lump at injection site and is itching. She reported this to vsafe also.
64 2021-05-06 sleep disorder 12 hours after receiving vaccine, extreme chilling which lasted through the night. Temperature taken... Read more
12 hours after receiving vaccine, extreme chilling which lasted through the night. Temperature taken in am was 102.9. Temperature throughout day remained over 101. Took Tylenol and drank water throughout day. Total exhaustion but no sleep. 48 hours after vaccine temperature became normal 98.3 and remained normal ever since. No appetite or energy. 4 days after vaccine, still no appetite, energy level better. I had Covid in November 2020. My Covid was better tolerated than either of my vaccines. Not a fan.
64 2021-05-07 loss of personal independence in daily activities Severe shaking for three hours, severe headache, nausea, dizziness, couldn't walk cause I was so sic... Read more
Severe shaking for three hours, severe headache, nausea, dizziness, couldn't walk cause I was so sick, extremely weakness, loss of taste, fever
64 2021-05-09 confusional state, disorientation Bad chills 12 hours after injection, large bump at injection site and bright red. 3-4 days after had... Read more
Bad chills 12 hours after injection, large bump at injection site and bright red. 3-4 days after had itching, extreme fatigue on day 2-4 days after, 4-6 days after had a bad headache, day's 6-8 had muscle aches, days 6-7 weaving all over the place, difficulty walking day 9 got disorientated and confused, difficulty speaking. injection site still red and tender at day 14.
64 2021-05-09 confusional state Presented to hospital with 1-2 days of fever, fatigue, confusion, and generalized weakness on 5/9/21... Read more
Presented to hospital with 1-2 days of fever, fatigue, confusion, and generalized weakness on 5/9/21. Primary diagnosis is acute encephalopathy.
64 2021-05-09 impaired work ability, memory impairment 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 loss of personal independence in daily activities, disturbance in attention 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 2021-05-09 sleep disorder patient awoke in the middle of the night with breathing difficulty, loss of taste and smell, headach... Read more
patient awoke in the middle of the night with breathing difficulty, loss of taste and smell, headache, dizziness and extremely fatigued
64 2021-05-10 impaired work ability, feeling abnormal Headache, lymph node swollen and painful on left side , dizziness off and on, (muscle ache and naus... Read more
Headache, lymph node swollen and painful on left side , dizziness off and on, (muscle ache and nausea two days) After 3 days still have sore lymph nodes and headache and was dizzy and sent home from work today. Off and on feeling of fatigue. Will feel wide awake and then overwhelmed with sleepiness for a bit then feel awake again for a bit. Weird.
64 2021-05-13 nervousness 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 2021-05-14 nervousness, anxiety Patient became "itchy" within 5 minutes after injection. She also was very nervous and anxious abou... Read more
Patient became "itchy" within 5 minutes after injection. She also was very nervous and anxious about getting her shot. She didn't seem to have a problem with the first dose. She was monitored by paramedics on scene at the mass vaccination clinic. Given Benadryl by paramedics and unsure if this was PO or IM. Patient felt better after 10 minutes of monitoring from paramedics.
64 2021-05-17 sleep disorder High-pitched, loud, continual tinnitus in both ears has interfered with my ability to sleep, and is ... Read more
High-pitched, loud, continual tinnitus in both ears has interfered with my ability to sleep, and is almost impossible to ignore when I'm awake. I have had mild tinnitus that comes and goes in one of my ears for a year, but this is unlike anything I've ever heard or experienced before.
64 2021-05-19 confusional state 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 2021-05-19 insomnia 4-09-21: (4 pm) Felt cold/chilled (7 pm) 2 separate but specific events of P... Read more
4-09-21: (4 pm) Felt cold/chilled (7 pm) 2 separate but specific events of Phantosmia each lasting about 15-20 minutes before disappearing: 1) strong aroma of bison urine--I thought my husband had wet the bed (he did not :) 2) strong aroma of burnt toast. (10 pm) Strong headache, chills to the point of shaking, skin felt hot like I was having hot flashes rolling in waves down my arms, significant arthralgia bilaterally from my shoulders down to my knuckles, ache at the site of injection, hard time sleeping, very very thirsty with increase in sweating and urination, sublingual temp of 98.4 (my usual is 96.6/96.8), nausea 04-10-21: (12 am) lower back pain (4:30 am) sublingual temp 100.4 (11 am) stiff neck. Took 2 (200 mg) Ibuprofen (5 pm) sublingual temp 97.8 nausea, headache and chills persisted on & off through 04-13-21
64 2021-05-22 excessive sleepiness 24 hrs after vaccine, Low grade fever, fatigue, localized pain left side of neck, pain left hip. Sle... Read more
24 hrs after vaccine, Low grade fever, fatigue, localized pain left side of neck, pain left hip. Slept for 14 hrs, then symptoms gone. Unknown days later, tinnitus started in both ears. Still continues constantly. Very loud at times.
64 2021-05-23 abnormal dreams, nightmare Needle separated from the syringe upon delivering the shot. So, I received some of the dose, was gi... Read more
Needle separated from the syringe upon delivering the shot. So, I received some of the dose, was given a full second dose immediately afterwards. (Not known the amount of vaccine I received, most likely 1.5 doses). For 2 nights, Very bad arthritis pain and stomach pains. Disturbing dreams nearly every night, since the 2nd shot(s)--nightmares continue..they have not subsided. Two days ago, woke up gasping for air. No idea why. Felt as though I was choking on something..it could only have been my saliva, or a spasm in my throat. It eased up after about 30 seconds...and I was able to catch a breath again. Right lung continues to have pain..from first shot..mild, but, it's there.
64 2021-05-24 feeling abnormal, delirium 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 2021-05-25 feeling abnormal 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 2021-05-25 sleep disorder Soreness, fever, pain in right arm started about three days after vaccination. Applied cold compress... Read more
Soreness, fever, pain in right arm started about three days after vaccination. Applied cold compress and took Ibuprofen or Aleve as recommended . Nagging pain still persists with great intensity at times, especially when I try to lift my arm. Disrupts my sleep at night. The arm muscle where injection was made is still sore two weeks after the second injection.
64 2021-05-26 confusional state 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 disturbance in attention Acute disseminated infectious encephalomyelitis. Symptoms included headache, weakness, fatigue, dif... Read more
Acute disseminated infectious encephalomyelitis. Symptoms included headache, weakness, fatigue, difficulty concentrating, body aches, chills, arm and leg numbness. Treated with solumedrol infusion.
64 2021-05-27 feeling abnormal, insomnia symptoms started spreading from the injection site to the whole arm; Worried about the side effects;... Read more
symptoms started spreading from the injection site to the whole arm; Worried about the side effects; Red injection site; Itchy injection site; Swollen injection site; It is very itchy, symptoms started spreading from the injection site to the whole arm; she cannot sleep at night; some of the red spot in her right arm, symptoms started spreading from the injection site to the whole arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-May-2021 and was forwarded to Moderna on 18-May-2021. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (some of the red spot in her right arm, symptoms started spreading from the injection site to the whole arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced ERYTHEMA (some of the red spot in her right arm, symptoms started spreading from the injection site to the whole arm) (seriousness criterion medically significant) and INSOMNIA (she cannot sleep at night). On an unknown date, the patient experienced PRURITUS (It is very itchy, symptoms started spreading from the injection site to the whole arm), SWELLING (symptoms started spreading from the injection site to the whole arm), FEELING ABNORMAL (Worried about the side effects), VACCINATION SITE ERYTHEMA (Red injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen injection site). At the time of the report, ERYTHEMA (some of the red spot in her right arm, symptoms started spreading from the injection site to the whole arm), PRURITUS (It is very itchy, symptoms started spreading from the injection site to the whole arm), INSOMNIA (she cannot sleep at night), SWELLING (symptoms started spreading from the injection site to the whole arm), VACCINATION SITE ERYTHEMA (Red injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen injection site) had not resolved and FEELING ABNORMAL (Worried about the side effects) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication information was provided treatment products for the symptoms were Cortisone cream , prednisone tablet ice affected area. Based on the current 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-2021-141702 (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 2021-05-27 loss of personal independence in daily activities Severe pain throughout whole body affecting mobility considerably ie; sitting, standing, walking, be... Read more
Severe pain throughout whole body affecting mobility considerably ie; sitting, standing, walking, bending over, getting in and out of car, etc
64 2021-05-27 memory impairment, feeling abnormal Extreme Fatigue and Brain Fog / Memory Issues / Tremors have increased / gait problems (have trouble... Read more
Extreme Fatigue and Brain Fog / Memory Issues / Tremors have increased / gait problems (have trouble walking in a straight line)
64 2021-05-30 feeling abnormal, loss of personal independence in daily activities 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 sensation of foreign body, panic attack 30 minutes later, flushing, dizziness, lightheadedness, panic and lump in throat. Lasted 20 minutes.... Read more
30 minutes later, flushing, dizziness, lightheadedness, panic and lump in throat. Lasted 20 minutes. No treatment
64 2021-06-01 sleep disorder . Patient described sores/blisters and tight skin all over neck, arms, and in hair. Patient states a... Read more
. Patient described sores/blisters and tight skin all over neck, arms, and in hair. Patient states a lot of pain and discomfort interrupting sleep. She has had increased migraines and flares in eczema (pre-existing conditions). Patient's states skin looked like it has burns on it around her neck and scaly and very irritated from itching and scratching
64 2021-06-02 sleep disorder On the evening of the injection I felt extreme fatigue (which I understand is not unusual) and went ... Read more
On the evening of the injection I felt extreme fatigue (which I understand is not unusual) and went to bed around 9:30 p.m. I was awakened by what seemed like "thundering" in my ears which I think was my blood pressure skyrocketing. I was too weak to move so I called my husband to take me to the emergency room. However, he was too tired to comprehend what I was saying at that hour. With great difficulty I got up and took 2 low dose aspirin and went back to bed, fearful that I would never wake up again. Around an hour (or what seemed like an hour) the thundering in my ear decreased and I was able to fall back to sleep.
64 2021-06-03 irritability, feeling abnormal didn't want to scratch arm because it looked as if it could break open; still throbbing/When patient... Read more
didn't want to scratch arm because it looked as if it could break open; still throbbing/When patient received dose it stung; skin was swelling/ lumpy; itchy/ it started blowing up again itching the heat /still itching really bad/ started blowing up again itching the heat; hot; weird soreness; red; arm felt angry; my doctor said it looked like cellulitis; they snaked around my arm to the top of my elbow; arm blew up; Skin had tiny little peelings; felt something weird; small area that felt like punched in arm and stiffness/stiffness and hotness is moving down to the elbow; felt a cold sensation crawling up arm; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (my doctor said it looked like cellulitis), CONDITION AGGRAVATED (they snaked around my arm to the top of my elbow), MUSCULOSKELETAL STIFFNESS (small area that felt like punched in arm and stiffness/stiffness and hotness is moving down to the elbow), SKIN EXFOLIATION (Skin had tiny little peelings), FEELING ABNORMAL (felt something weird), VACCINATION COMPLICATION (didn't want to scratch arm because it looked as if it could break open) and IRRITABILITY (arm felt angry) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history provided. No concomitant medication information provided. Concurrent medical conditions included Arthritis. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced FEELING COLD (felt a cold sensation crawling up arm). On 05-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (small area that felt like punched in arm and stiffness/stiffness and hotness is moving down to the elbow) (seriousness criterion medically significant). On 14-May-2021, the patient experienced CELLULITIS (my doctor said it looked like cellulitis) (seriousness criterion medically significant), CONDITION AGGRAVATED (they snaked around my arm to the top of my elbow) (seriousness criterion medically significant), LIMB DISCOMFORT (arm blew up), SKIN EXFOLIATION (Skin had tiny little peelings) (seriousness criterion medically significant), FEELING ABNORMAL (felt something weird) (seriousness criterion medically significant), IRRITABILITY (arm felt angry) (seriousness criterion medically significant), VACCINATION SITE WARMTH (hot), MYALGIA (weird soreness) and VACCINATION SITE ERYTHEMA (red). On 15-May-2021, the patient experienced PRURITUS (itchy/ it started blowing up again itching the heat /still itching really bad/ started blowing up again itching the heat) and VACCINATION SITE SWELLING (skin was swelling/ lumpy). On 17-May-2021, the patient experienced VACCINATION SITE PAIN (still throbbing/When patient received dose it stung). On an unknown date, the patient experienced VACCINATION COMPLICATION (didn't want to scratch arm because it looked as if it could break open) (seriousness criterion medically significant). On 26-May-2021, CELLULITIS (my doctor said it looked like cellulitis), CONDITION AGGRAVATED (they snaked around my arm to the top of my elbow), LIMB DISCOMFORT (arm blew up), SKIN EXFOLIATION (Skin had tiny little peelings) and FEELING ABNORMAL (felt something weird) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (small area that felt like punched in arm and stiffness/stiffness and hotness is moving down to the elbow), FEELING COLD (felt a cold sensation crawling up arm), IRRITABILITY (arm felt angry), MYALGIA (weird soreness), VACCINATION SITE PAIN (still throbbing/When patient received dose it stung), VACCINATION SITE SWELLING (skin was swelling/ lumpy) and VACCINATION SITE ERYTHEMA (red) outcome was unknown and VACCINATION COMPLICATION (didn't want to scratch arm because it looked as if it could break open), PRURITUS (itchy/ it started blowing up again itching the heat /still itching really bad/ started blowing up again itching the heat) and VACCINATION SITE WARMTH (hot) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Case Crosslinked to MOD21-091006. On Thursday, May 20, 2021- Patient reports that it has been 7 days since her first dose of vaccine and her doctor has put her on antibiotics and prednisone. On Mon, May 17, 2021, Patient is sending pictures of her arm. On Mon, May 17, 2021, 11:45 AM- Patient reported she was still itching really bad even after taking allegra. The only thing that would stop the itching was mentholatum. Crosslinked MOD21-091028 and MOD21-091029 Patient received first dose on 4 May 2021 at 2;30p at a drug store with lot #017C21A in left arm(non-dominant). The over 9 days later on Friday night, she felt a weird soreness and arm felt angry, red and hot. Patient called her doctor who saw a picture of her arm and told her to take Norco that she used for arthritis. The following day her skin felt itchy and swollen- she called her pharmacist who asked her to take Allegra. Patient also reports applying coconut oil and a vapor rub on arm to help her sleep. Patient is scheduled to receive her second dose of the Moderna vaccine tomorrow, 01Jun2021. She had already provided her demographics and her health care and vaccine facility information with previous call. Patient had recently emailed photos of her adverse events. Patient stated she prefers to be contacted by email and not by telephone. No further information 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 17-May-2021: Additional information received on 17-May-2021 and Pictures of events updated. On 17-May-2021: Additional information received on 17-May-2021 and Event details and treatment information was updated. On 20-May-2021: Follow up information received on 20-may-2021 and Patient treatment details and doctor description were added. On 31-May-2021: Follow up information received on 31-May-2021 and new events were added, Case is upgraded from non-serious 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.
64 2021-06-06 hallucination The day I got it I had Headache body aches fever, chills, urine smelled like sewer fever went up to ... Read more
The day I got it I had Headache body aches fever, chills, urine smelled like sewer fever went up to 104 in the night my legs couldn't hold me up I was hallucinating and thought I was going to die. Next day Tylnol kept fever to 101. still had Headache and body aches no energy Saturday was washed out n no energy n headache. Sunday a headache n today Monday a headache still and urine still smells bad
64 2021-06-08 sensation of foreign body sores in mouth on gums, roof, cheeks. dry lump in throat that ached and water wouldn't quench it.
64 2021-06-09 disorientation, confusional state, panic attack I had severe reactions from the covid-19 vaccine the evening of receiving the vaccine, 02-24-2021. ... Read more
I had severe reactions from the covid-19 vaccine the evening of receiving the vaccine, 02-24-2021. I had to go to the ER with fever, shakes, shortness of breath, headache, clammy feeling, elevated BP, nausea-vomiting, lethargic, confusion-disoriented, panic attacks, constipation, gallbladder pain & stomach pain. I am still having some of these symptoms to this day, 06-10-2021. I request to have the medical charges for the ER bill, the radiology bill and the Dr bill compensated, due to my insurance not paying these charges.
64 2021-06-09 feeling abnormal She got her vaccine, at home as Public Health came and gave it to her, she was fine for 15 minutes,... Read more
She got her vaccine, at home as Public Health came and gave it to her, she was fine for 15 minutes, and she came upstairs and she started having a hard time swallowing and breathing. She had experienced that before and stayed calm, and probably about an hour it passed. She then she started feeling really weird and in a day she started having uncontrolled shaking, and put on a sweatshirt, coat and she continued to shake, and got under the covers and could not stop shaking with the chills. She was then sick to her stomach and could hardly stand up, she has two broken feet and was not able to stand that lasted for about a week. Every part of her was hurting and she was afraid to get up for fear of falling. After a week the reaction started to subside and in the meantime she developed hives on the back of her legs and on her stomach. The one on her stomach was so bad that it was the size of a grapefruit, and looked like she had been severely burnt, which is now basically just going away and has lasted for over a month. It was next to the wound that has not closed from her previous surgery. The blister was full of liquid which she left alone for it to heal on it's own. She had a telehealth conference with her endocrinologist who told her that she was not to get any vaccines of any kind. Public Health did call her the day before the 2nd shot and she explained to the supervisor what had happened and she also informed her that they would not give it to her and not to get the 2nd vaccine or any other vaccines. This supervisor was part of the team that was trying to get her to heal with the wound vac from her previous surgery. She does not carry an Epi-Pen for any other allergic reactions.
64 2021-06-09 feeling abnormal I was vaccinated on 2/13/21 at 9:30 AM. Within 12 hours, I started having symptoms. It started with ... Read more
I was vaccinated on 2/13/21 at 9:30 AM. Within 12 hours, I started having symptoms. It started with a headache, possibly a fever, chills. I felt extremely tired and I was in a fog for a couple of days. After that, I had stomach ache and diarrhea. I threw up once and had diarrhea a couple of times. I had a rash on both arms and my chest, my neck, and half of my face. As of now, my left armpit still aches frequently (almost constantly). I now have constant postnasal drip, and I never had that before the vaccine. After my vaccine, my symptoms lasted 7-8 days, though I still have the postnasal drip and achy armpit.
64 2021-06-12 loss of personal independence in daily activities EXTREME FATIGUE AND MUSCLE FATIGUE PARTICULARLY IN LEGS, DIFFICULTY CLIMBING STAIRS, SOB WHEN CLIMB... Read more
EXTREME FATIGUE AND MUSCLE FATIGUE PARTICULARLY IN LEGS, DIFFICULTY CLIMBING STAIRS, SOB WHEN CLIMBING STAIRS. CANNOT WALK LONG DISTANCES (1 MILE) CAN NO LONGER EXERCISE DUE TO EXTREME FATIGUE
64 2021-06-14 loss of personal independence in daily activities, impaired work ability, sleep disorder I developed severe pain in my arm and difficulty moving it. It was also stiff. I couldn't extend my ... Read more
I developed severe pain in my arm and difficulty moving it. It was also stiff. I couldn't extend my arm out towards my back. I went to the doctor. They did an X-ray but they only found a small bone spur that was unrelated to my symptoms. I was told I had developed adhesive capsulitis aka frozen shoulder. They gave me a steroid pack and Voltaren which did nothing. I went back after there was no improvement. They then prescribed physical therapy. I went back again and the prescription was extended again. They put me on a two week break and I will continue again. The physical therapy has helped but I still have pain. I have hit a plateau where it has eased but is not getting any more better. I still cannot extend my arm back. It actually interferes with sleeping. It interferes with everything in my daily life and work. Frozen shoulder lasts quite a long time, usually 1-2 years. I have had 20 physical therapy sessions. I know that the vaccine was administered correctly. I have experienced these symptoms before following the flu vaccine 4 years ago.
64 2021-06-15 confusional state Dizziness, balance, pressure in head, confusion, given dizzy medicine, then antibiotics for ear infe... Read more
Dizziness, balance, pressure in head, confusion, given dizzy medicine, then antibiotics for ear infection, then sent to neurologist for further testing
64 2021-06-17 feeling drunk - 64yoF presents with a cc of dizziness that started one week after getting her covid vaccine - symp... Read more
- 64yoF presents with a cc of dizziness that started one week after getting her covid vaccine - symptoms started 2 weeks ago, comes and goes; can occur at rest but especially occurs with movement - describes it as room spinning, feels like she is drunk; she has never had this before - at onset of symptoms, she had R ear pain and worsening sinus congestion; she was placed on augmentin and pseudophed by her pcp; her sinus congestion has since resolved but dizziness has not - has had gait instability; feels like her balance is off - reports very faint headache, barely there; has a hx of migraines, this is much less and doesn't happen every day, comes and goes; her migraines when she gets them her R eye hurts, she has had this recently - has been taking meclizine which help somewhat - denies changes in her vision; denies numbness or weakness, changes in speech, trouble swallowing - denies chest pain - had first dose of moderna on 5/18
64 2021-06-18 feeling abnormal A large red patch appeared on my arm near but not on the injection site. It stayed for nearly two we... Read more
A large red patch appeared on my arm near but not on the injection site. It stayed for nearly two weeks, waxing and waning back and forth over the time period, until it finally faded permanently. It was slightly itchy the first day or two but then gave me no trouble at all, other than being warm to the touch like a tiny fever. I mostly ignored it other than checking every few days to see if it was still there.
64 2021-06-22 feeling drunk Had fallen asleep on the couch and I went to get up and I fell. I stood up and tried to walk again a... Read more
Had fallen asleep on the couch and I went to get up and I fell. I stood up and tried to walk again and fell again. I was very dizzy. And when I woke up in the morning, I still was very dizzy and it felt like I was super, super drunk - bouncing off the walls when I try to move. I waited to see if it would clear up. It didn't. My daughter took me to ER at 1:00 pm. Diagnosed as Vertigo . They gave me two medications - Meclizine and Promethazine - I'm still taking those. That has helped. Two days I was good, I was back to normal. But yesterday, it was back again (the dizziness) - it's like I'm drunk but not falling into the walls - just dizzy. It's still here today. (Dizziness). Upcoming appointments in July - one with a Neuro doc and one with a new primary care doctor.
64 2021-06-23 sleep disorder 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 2021-06-28 sleep disorder After my 2nd dose on 3/10/2021 I was awaken at 11:40 pm gasping for air. I called 911 because I was ... Read more
After my 2nd dose on 3/10/2021 I was awaken at 11:40 pm gasping for air. I called 911 because I was having such a hard time. I managed to get my rescue inhaler and get 3 puffs into me. That eased my breathing so at that point I told 911 I would call if I needed them. I stayed up and used my inhaler 3 more times. On the 11th of March I was in so much pain. It was like my body was one massive pain ball. On the 12th of March I could not move my wrists. They were very painful and stiff. I tried everything I knew over the course of a few days but when it got bad I called the doctor. She gave me some Prednisone to help the inflammation. A few days later I started with a cough, wheezing, and green and yellow sputum coming from my lungs. I called the doctor who gave me a Prednisone dose pack, a ZPac and some Mucinex. I did it for 5 days but with very little relief. I called the doctor and told her I was in pain and just not doing well. She then ordered some blood work. She then put me on some Prednisone daily and gave me a nebulizer treatment. I have been SOB since the 11th of March and it hasn't gotten much better. About a week later I wasn't any better so she increased the Prednisone, gave me Amoxiclave and more nebulizer treatments. Since then I have had shortness of breath, bilateral lower leg swelling and pain through out my entire body. She has since changed me to Lasix 10 mg one in morning and once at night. I have gained 35 pounds which makes this even worse.
64 2021-06-30 impaired work ability WOKE UP NEXT MORNING WITH A BIT OF A HEADACHE ( 6AM), WENT TO WORK,,, STARTED TO FEEL BAD AS THE MOR... Read more
WOKE UP NEXT MORNING WITH A BIT OF A HEADACHE ( 6AM), WENT TO WORK,,, STARTED TO FEEL BAD AS THE MORNING PROGRESSED. BY NOON . I HAD A FEVER OF 105, SEVERE HEADACHE, CHILLS, BODY ACHES AND BY 1 PM , WAS EXPERIENCING SOB, MY COWORKER TOOK ME THE THE FAMILY PRACTICE IN THE SAME BUILDING. SHE VERIFIED MY SYMPTOMS AND ORDERED A RAPID COVID TEST AND FLU TEST,,BOTH WERE NEG. HAD TO BE DRIVEN HOME,,MISSED THE NEXT 3 DAYS OF WORK. BREATHING ISSUE EASED LATER ON FEB 3, BUT REST OF SYYMPTONS NOT TIL THE WEEKEND.
64 2021-07-02 confusional state 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 feeling abnormal 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 2021-07-11 impaired work ability 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 2021-07-12 feeling abnormal Had typical response, sore arm, chills, fever, aches general not feeling well for many days. Around... Read more
Had typical response, sore arm, chills, fever, aches general not feeling well for many days. Around May 7, woke up very dizzy when getting out of bed, laying down at night room would spin like a tornado for 30 seconds. head in a fog, light headed during day off and on. Ears felt pressure, thought maybe ear or sinus infection. After a week did telecon phone call with doctor office on 5/14/21 and finally office visit on 5/17/21. no real results given vertigo exercises. It is now 7/13/21 and I still have the problem. some days worse than others. On 7/2/21 I actually fell and now have a broken arm.
64 2021-07-13 insomnia, memory impairment, feeling abnormal increased fatigue with exercise and being out in the sun; memory is shot, memory problems; trouble w... Read more
increased fatigue with exercise and being out in the sun; memory is shot, memory problems; trouble with sleep at times; double vision episode, had some double vision; bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water; big crowds cause her stress; wording is getting worse; worsening bladder control; drunken walk, she was like walking in like she's drunk, and running into the door way; steroids gave him black sticky diarrhea; speech has been slurred; dry mouth; nurse was not able to clarify some cognitive issue; severe cold/ bad cold; she was hospitalized for a blood infection; filed for disability worsening of her MS; bruising; hair loss or bald spots/hair thinning; feel the burning in both feet; numbness on bottom of both feet; steroids gave him black sticky diarrhea; balance disorder; had a lapse on therapy, was out of medicine for about a week; dizziness; felt like a train ran over her; underdose of the medications; had an ulcer in her stomach, which was new to her and bleeding also; started breaking the medication in half/ has been braking 14mg in half to make it last longer; had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (felt like a train ran over her), BALANCE DISORDER (balance disorder), GASTRIC ULCER HAEMORRHAGE (had an ulcer in her stomach, which was new to her and bleeding also), SEPSIS (she was hospitalized for a blood infection), MULTIPLE SCLEROSIS (filed for disability worsening of her MS), CONTUSION (bruising), DIZZINESS (dizziness), FATIGUE (increased fatigue with exercise and being out in the sun), MEMORY IMPAIRMENT (memory is shot, memory problems), INSOMNIA (trouble with sleep at times), DIPLOPIA (double vision episode, had some double vision), PERIPHERAL COLDNESS (bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water), SOCIAL ANXIETY DISORDER (big crowds cause her stress), APHASIA (wording is getting worse), URINARY INCONTINENCE (worsening bladder control), GAIT DISTURBANCE (drunken walk, she was like walking in like she's drunk, and running into the door way), FAECES DISCOLOURED (steroids gave him black sticky diarrhea), DYSARTHRIA (speech has been slurred), DRY MOUTH (dry mouth), COGNITIVE DISORDER (nurse was not able to clarify some cognitive issue), NASOPHARYNGITIS (severe cold/ bad cold), PARAESTHESIA (had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and), ALOPECIA (hair loss or bald spots/hair thinning), BURNING SENSATION (feel the burning in both feet), HYPOAESTHESIA (numbness on bottom of both feet), DIARRHOEA (steroids gave him black sticky diarrhea), PRODUCT DOSE OMISSION ISSUE (had a lapse on therapy, was out of medicine for about a week) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (started breaking the medication in half/ has been braking 14mg in half to make it last longer) 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. Co-suspect products included non-company products TERIFLUNOMIDE for an unknown indication, BUPROPION HCL for an unknown indication and WARFARIN SODIUM (COUMADIN) for an unknown indication. The patient's past medical history included Rheumatic fever, Application site reaction, Diplopia and Cardiac valve prosthesis user in 2007. Concurrent medical conditions included Allergy to animal, Drug hypersensitivity (Triple antibiotic), Iodine allergy (Iodine dye), Polyuria, Dermatitis contact, Drug hypersensitivity (Dilantin) and Multiple sclerosis. Concomitant products included LEVOTHYROXINE, IRON, METOPROLOL, FUROSEMIDE, PRAVASTATIN, WARFARIN SODIUM (JANTOVEN), VITAMIN D3, ACETYLSALICYLIC ACID (ASPIRIN COX [ACETYLSALICYLIC ACID]) and SERTRALINE for an unknown indication. On 15-May-2014, the patient started TERIFLUNOMIDE (unknown route) 14 milligram once a day. On 14-Mar-2021, received 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, BUPROPION HCL (unknown route) 1 dosage form and WARFARIN SODIUM (COUMADIN) (unknown route) at an unspecified dose. In March 2015, the patient experienced PARAESTHESIA (had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and) (seriousness criteria hospitalization prolonged and disability). In January 2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (started breaking the medication in half/ has been braking 14mg in half to make it last longer) (seriousness criteria hospitalization prolonged and disability). On 14-Feb-2021, the patient experienced GASTRIC ULCER HAEMORRHAGE (had an ulcer in her stomach, which was new to her and bleeding also) (seriousness criteria hospitalization prolonged, disability and medically significant). On 14-Mar-2021, the patient experienced FEELING ABNORMAL (felt like a train ran over her) (seriousness criteria hospitalization prolonged and disability). 14-Mar-2021, the patient experienced UNDERDOSE (underdose of the medications). In May 2021, the patient experienced DIZZINESS (dizziness) (seriousness criteria hospitalization prolonged and disability) and PRODUCT DOSE OMISSION ISSUE (had a lapse on therapy, was out of medicine for about a week) (seriousness criteria hospitalization prolonged and disability). On 19-Jun-2021, the patient experienced BALANCE DISORDER (balance disorder) (seriousness criteria hospitalization prolonged and disability). On an unknown date, the patient experienced SEPSIS (she was hospitalized for a blood infection) (seriousness criteria hospitalization prolonged, disability and medically significant), MULTIPLE SCLEROSIS (filed for disability worsening of her MS) (seriousness criteria hospitalization prolonged, disability and medically significant), CONTUSION (bruising) (seriousness criteria hospitalization prolonged and disability), FATIGUE (increased fatigue with exercise and being out in the sun) (seriousness criteria hospitalization prolonged and disability), MEMORY IMPAIRMENT (memory is shot, memory problems) (seriousness criteria hospitalization prolonged and disability), INSOMNIA (trouble with sleep at times) (seriousness criteria hospitalization prolonged and disability), DIPLOPIA (double vision episode, had some double vision) (seriousness criteria hospitalization prolonged and disability), PERIPHERAL COLDNESS (bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water) (seriousness criteria hospitalization prolonged and disability), SOCIAL ANXIETY DISORDER (big crowds cause her stress) (seriousness criteria hospitalization prolonged and disability), APHASIA (wording is getting worse) (seriousness criteria hospitalization prolonged and disability), URINARY INCONTINENCE (worsening bladder control) (seriousness criteria hospitalization prolonged and disability), GAIT DISTURBANCE (drunken walk, she was like walking in like she's drunk, and running into the door way) (seriousness criteria hospitalization prolonged and disability), FAECES DISCOLOURED (steroids gave him black sticky diarrhea) (seriousness criteria hospitalization prolonged, disability and medically significant), DYSARTHRIA (speech has been slurred) (seriousness criteria hospitalization prolonged and disability), DRY MOUTH (dry mouth) (seriousness criteria hospitalization prolonged and disability), COGNITIVE DISORDER (nurse was not able to clarify some cognitive issue) (seriousness criteria hospitalization prolonged, disability and medically significant), NASOPHARYNGITIS (severe cold/ bad cold) (seriousness criteria hospitalization prolonged and disability), ALOPECIA (hair loss or bald spots/hair thinning) (seriousness criteria hospitalization prolonged and disability), BURNING SENSATION (feel the burning in both feet) (seriousness criteria hospitalization prolonged and disability), HYPOAESTHESIA (numbness on bottom of both feet) (seriousness criteria hospitalization prolonged and disability) and DIARRHOEA (steroids gave him black sticky diarrhea) (seriousness criteria hospitalization prolonged, disability and medically significant). The patient was treated with OXYBUTYNIN ongoing since an unknown date for Urinary incontinence, at a dose of 1 dosage form; PARACETAMOL ongoing since an unknown date for Insomnia, at a dose of 1 dosage form; DIPHENHYDRAMINE ongoing since an unknown date for Insomnia, at a dose of 1 dosage form and BENZOCAINE ongoing since an unknown date for Hypoaesthesia and Burning sensation, at a dose of 1 dosage form. On 23-Feb-2021, GASTRIC ULCER HAEMORRHAGE (had an ulcer in her stomach, which was new to her and bleeding also) had resolved. At the time of the report, FEELING ABNORMAL (felt like a train ran over her), BALANCE DISORDER (balance disorder) and SEPSIS (she was hospitalized for a blood infection) had resolved, MULTIPLE SCLEROSIS (filed for disability worsening of her MS), CONTUSION (bruising), DIZZINESS (dizziness), FATIGUE (increased fatigue with exercise and being out in the sun), MEMORY IMPAIRMENT (memory is shot, memory problems), DIPLOPIA (double vision episode, had some double vision), PERIPHERAL COLDNESS (bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water), SOCIAL ANXIETY DISORDER (big crowds cause her stress), APHASIA (wording is getting worse), URINARY INCONTINENCE (worsening bladder control), GAIT DISTURBANCE (drunken walk, she was like walking in like she's drunk, and running into the door way), FAECES DISCOLOURED (steroids gave him black sticky diarrhea), DYSARTHRIA (speech has been slurred), DRY MOUTH (dry mouth), NASOPHARYNGITIS (severe cold/ bad cold), ALOPECIA (hair loss or bald spots/hair thinning), DIARRHOEA (steroids gave him black sticky diarrhea), PRODUCT DOSE OMISSION ISSUE (had a lapse on therapy, was out of medicine for about a week), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (started breaking the medication in half/ has been braking 14mg in half to make it last longer) and UNDERDOSE (underdose of the medications) outcome was unknown and INSOMNIA (trouble with sleep at times), COGNITIVE DISORDER (nurse was not able to clarify some cognitive issue), PARAESTHESIA (had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and), BURNING SENSATION (feel the burning in both feet) and HYPOAESTHESIA (numbness on bottom of both feet) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: low (Low) Low. On an unknown date, International normalised ratio: 6.28 (Inconclusive) 6.28. 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. 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.
64 2021-07-14 feeling abnormal, depressed mood I had a runny nose. I had some allergies that I had never had before. My eyes had some stuff in them... Read more
I had a runny nose. I had some allergies that I had never had before. My eyes had some stuff in them. I went to the eye doctor and they gave me allergy drops. I thought I had pink eye, but I didn't. I have been having problems with my stools. They have been really greasy. My legs were swollen really bad. My legs are still swollen. I went to the urgent care for my allergies on May 22, 2021. I was extremely tired after getting my vaccine and I am finally starting to have my energy back. I was also kind of depressed. I usually don't feel like that.
64 2021-07-14 feeling abnormal On May 8th, I was at my grandchild's football game. I was outside for over 3 hours. It was a very wi... Read more
On May 8th, I was at my grandchild's football game. I was outside for over 3 hours. It was a very windy day, and I had a lot of coffee. In the evening, I went to my grandchild's concert at school at 7:00PM. While at the concert, my neck started throbbing and I started getting a headache. When the concert ended, I started having trouble walking back to the vehicle. I wasn't able to get out of the truck or walk myself to the door, so my son had to help me. When I got home, I took some Excedrin or Tylenol, but after a bit, I ended up throwing up. I was in my bed and I was so dizzy that I couldn't get up, so I threw up on my feet and the floor. The next morning, I woke up and felt like I had the flu. I threw up several times over the weekend. Come Monday, 05/10/2021, I asked my son if he could pick up some Pepto bismol because it helped a bit. On Monday evening, my son bought me a humidifier because we thought that maybe it was a sinus infection. On Wednesday, 05/12, I had to take an Uber to the hospital. While I was at the hospital, I had an MRI, a CT scan and blood work drawn. At first, they thought there was a blood clot in my lungs, but then it was ruled out. They gave me Benadryl and something else (he called it a cocktail). It took away some of the pain, but the headache never went away. They kept me overnight for observation and to do a second MRI in the morning. I was on a heart monitor the whole time. I saw a doctor before I left, and they weren't able to locate any problems. They came up with migraines. I was given a shot of sumatriptan and the same medicine in pill form 100mg to take when I was at home. As of today, 3 months after receiving my vaccine, I am still feeling foggy, and I have had quite a few headaches. I ended up seeing a Neurologist. With the medicine she gave me, I have not been feeling like myself at all. I stopped taking the medicine on 07/08/2021.
64 2021-07-15 feeling abnormal First 2 nights chills, 3 day broke out in a horrible itching rash From my elbows dow and my right s... Read more
First 2 nights chills, 3 day broke out in a horrible itching rash From my elbows dow and my right side of face, very swollen , skin felt like leather, horrible itching. Went to dr and they couldn?t do anything because they didn?t want it to affect shot. It lasted into two weeks, I was so miserable
64 2021-07-16 insomnia Insomnia. I take trazodone for sleep which has worked for years. Since getting the shot 2 weeks ago... Read more
Insomnia. I take trazodone for sleep which has worked for years. Since getting the shot 2 weeks ago I havent slept more than 4-5 hours a night, waking in the early morning 2-4 am , unable to go back to sleep. This is ongoing.
64 2021-07-17 impaired work ability, feeling abnormal 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 2021-07-20 fear Days after 2nd dose noticed odd grainy rash around eyes. Kind of like liquid sand. Just around eyes ... Read more
Days after 2nd dose noticed odd grainy rash around eyes. Kind of like liquid sand. Just around eyes near nose. Also noticed Rosacea suddenly got worse around same time (which never happened before). Rash (not sure what else to call it) lasted about 3 weeks, almost disappeared, then returned in early June. Saw doctor for unrelated illness on 6/24/21, and she noticed eyes. Said it was infection, possibly complication of Rosacea, and prescribed Doxycycline Hydrate 100mg 2x/day for 10 days. Mostly improved after treatment. Returned shortly after. Saw different doctor on 7/14/21. He prescribed same but added 100mg 1x/day for 20 days. Two days after seeing him (did not start 2nd round of Doxy until 7/17/21) rash got much. worse on 7/16/21, spreading throughout face and into eyes. As I type this on 7/22/21, there is no improvement. As my only income is SS Disability, I do not have funds to see a Dermatologist or Optometrist, even though my vision is in danger. Obviously, I don't know if this was caused by the vaccine. All I know is that it started around the time of the 2nd dose on 5/14/21. I have taken 1 Pneumonia vaccine and flu vaccine for many years and never had a reaction, but I understand the MRNA technology is different. Now my big concern (in addition to this condition) is if I can get a booster when available or any other vaccine. I was intending on getting the Shingles vaccine, but now I am afraid to get anything. All that said, I am thankful for the vaccines and would rather be dealing with this than Covid.
64 2021-07-21 impaired work ability, loss of personal independence in daily activities A few hours afterwards I had a fever of 102. I rarely get sick. I dehydrated out, I could not keep o... Read more
A few hours afterwards I had a fever of 102. I rarely get sick. I dehydrated out, I could not keep on top of the fever. I was extremely fatigued. My arm hurt. I had muscles aches everywhere. Joint pain. It progressed to the left side of my body, ear ache, swollen nodes, extremely sore throat, and my teeth hurt only on the left side. I could not stay awake. I cancelled patients for like a week and a half which I never do. I shipped the dogs to a pet sitter because I could not take of them. I could not eat or drink anything. The fever went away after a couple of days but the pains did not. I called the doctor and she said to stay on Tylenol. I have never been that sick in my life.
64 2021-07-22 feeling abnormal June 13, 2021 I had a severe headache on the right side of my face. It made me feel like I was going... Read more
June 13, 2021 I had a severe headache on the right side of my face. It made me feel like I was going to throw up, my eyes watered. The following Thursday I had severe pressure in the back on my head, I started to lose my balance. On Sunday on the 20th went to the bathroom and got a severe headache that lasted a couple hours. Went to the doctor no diagnosis. I felt spacey for a couple days.
64 2021-07-25 thinking abnormal, confusional state, amnesia CONFUSED THINKING MEMORY LOSS
65 2021-01-03 anxiety Uneasiness, tightness in throat, nausea. Administered Epi Pen
65 2021-01-03 feeling abnormal 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 2021-01-03 impaired work ability, crying Pt. calls into work on 12/28/2020 crying and reports that she is not able to move or turn in bed wit... Read more
Pt. calls into work on 12/28/2020 crying and reports that she is not able to move or turn in bed without having sever discomfort in her neck; therefore unable to work her scheduled shift. Pt. reports with movement of her arms esp. her left arm that she gets "shooting pain" with radiation to the nap of her neck. Pt. denies any fevers at this time. Pt. reports that she had medicated with Tylenol Arthritis without relief. Pt. reports noticing muscle aches and discomfort on 12/26 but on 12/28/2020 is severe in nature. Pt. made an appointment with her PCP on 12/28/2020 at 1400. Pt. was instructed to take Ibuprofen 200 mg tid for a total of 600 mg as needed, cont. to use ice at home and was given Diazepam as a muscle relaxant. On 12/29/20 pt. was able to return to work and reported feeling better. Pt. returned to the clinic on 12/30/2020 again with severe discomfort in the shoulders, neck and upper body. Pt. was seen by PA-C and was administered a shot of Toradil IM, placed on Prednisone 40 mg for 5 days, lab was obtained and was instructed to cont. with the ice and Ibuprofen.
65 2021-01-04 depressed mood, restlessness 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 2021-01-06 restlessness, insomnia Dizziness restlessness, insomnia, lightheadedness, sore arm, body aches
65 2021-01-07 disturbance in attention awakened at 0500 the following morning with a blinding migraine and nausea. Prior to that there wer... Read more
awakened at 0500 the following morning with a blinding migraine and nausea. Prior to that there were no sequelae. No redness or swelling at the injection site; mild generalized muscle aches. Took ibuprofen 600 mg tid for 36 hours. Additional -- difficulty concentrating, some word finding issues and fatigue. Symptoms resolved after 52 hours.
65 2021-01-07 excessive sleepiness On 12/31/20 at 2:00pm I developed a HA, with chills, & body aches. My right arm started to swell, ... Read more
On 12/31/20 at 2:00pm I developed a HA, with chills, & body aches. My right arm started to swell, redness from injection site approx. 6 inches very painful On Jan 1st temp 100.9 HA body aches and slept all day in bed. The redness in my arm finally went away on 1/7/2021
65 2021-01-10 feeling abnormal Patient stated she felt "funny" ~10 minutes after vaccination, felt "cold in chest and waves of ting... Read more
Patient stated she felt "funny" ~10 minutes after vaccination, felt "cold in chest and waves of tingling", initially diaphoretic with BP 175/110, HR 110. AFter 15 minutes patient stated she felt better but noted vision was still slightly blurry. After 45 minutes vitals were BP 175/90, HR 88 with ongoing periods of blurry vision and tingling in extremities.
65 2021-01-10 feeling abnormal I sat for 30 mins after the vaccine at the doctors office. When I got home I started feeling my hea... Read more
I sat for 30 mins after the vaccine at the doctors office. When I got home I started feeling my heart beating and started feeling like my body was raising. After 10 mins I checked my BP 140/90 which is high for me. I took a BP pill. It took a couple of hours for it to come down to normal. Went to sleep and woke up BP normal and a slight headache. My arm was sore lasting about 3 days.
65 2021-01-11 confusional state Fever (100.2 F), SaO2 saturation decrease to 79%, confusion, weakness (lasted 2 days)
65 2021-01-11 feeling abnormal 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 feeling abnormal 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 impaired work ability 48 hours after the injection I began to notice a sore throat before bedtime on Dec 30, but slept wel... Read more
48 hours after the injection I began to notice a sore throat before bedtime on Dec 30, but slept well. The next morning, Dec 31, I had acute allergic symptoms that never start so suddenly. I was having constant Post-nasal Drip, nasal congestion and beginning of cough due to PND. That night I had a severe sore throat similar to my typical allergic pattern. I coughed all night and awoke on the morning of Jan 1st with clear severe onset allergies and could not talk without coughing. That persisted for 4 days, then my allergist prescribed inhaled steroids BID which reduced the nighttime cough, but I persisted with symptoms for 10 days when they slowly resolved and my sense of well-being returned. I missed 7 days of work, which is atypical for my allergies when I catch them early. This was an acute flare of typical allergic symptoms that seems to have been triggered by the timing of the immune change from the vaccine at day #2-3 after the vaccine #1 was given. I am worried about getting vaccine #2 in 2 weeks and don't want to go through another flare up of dialing allergies again.
65 2021-01-12 impaired work ability on 1/2 to 1/4 experienced extreme fatigue on 1/4 developed chills and fever of 102 which lasted 2 da... Read more
on 1/2 to 1/4 experienced extreme fatigue on 1/4 developed chills and fever of 102 which lasted 2 days along with body aches and headache last day of fever was 1/5 returned to work on 1/7. was feeling fine then on 1/9 at night started with chills, fever of 102 extreme weakness, tiredness, headache dizziness, on 1/10 continued with chills and fever, tiredness, weakness, and dizziness vomited x1. had loss of appetite but was able to keep fluids down fever continued until the evening of 1/11 which was 101.8 but was unable to keep fluids down but only vomited x 2. I remained NPO for 2 hrs and then was able to tolerate small sips of fluids on 1/12 no fever in am was able to tolerate plain toast and fluids appetite returning later that night and was able to tolerate soup had no fever since 1/11 Monday evening and was able to return to work on 1/13. I was unable to work on 1/11 and 1/12
65 2021-01-14 abnormal dreams, confusional state, mental status changes 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 2021-01-14 insomnia Loss of range of motion; Can't sleep; Pain at the injection site; Vaccine was given in the left delt... Read more
Loss of range of motion; Can't sleep; Pain at the injection site; Vaccine was given in the left deltoid bursa instead of the deltoid muscle; A spontaneous report was received from a 65 year-old, female physician, who is also the patient, who received Moderna's COVID-19 vaccine and experienced vaccine was given in the left deltoid bursa instead of the deltoid muscle, loss of range of motion, can't sleep, and pain at the injection site. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 02 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramurally in the left deltoid bursa for prophylaxis of COVID-19 infection. On 02 Jan 2021, the patient reported she had been given the vaccine in the wrong location. The vaccine was given in the left deltoid bursa instead of the deltoid muscle. The patient was also experiencing loss of range of motion, pain at the injection site, and she also can't sleep. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The event vaccine was given in the left deltoid bursa instead of the deltoid muscle was considered resolved on 02 Jan 2021. The events loss of range of motion, can't sleep, and pain at the injection site were considered not recovered/not resolved.; Reporter's Comments: This report refers to a case of 65 year old female patient who experienced non-serious unexpected events of vaccine was given in the left deltoid bursa instead of the deltoid muscle for mRNA-1273, lot # 011L20A. The patient experienced loss of range of motion, pain at the injection site, and can't sleep. Onset latency was not provided. De-challenge and re-challenge are not applicable. Based on the information provided the events of vaccine was given in the left deltoid bursa instead of the deltoid muscle, loss of range of motion and can't sleep are assessed as unlikely related to mRNA-1273 as this is due to product administration error. The event of pain at the injection site is included in the known safety profile of the vaccine, hence a causal association cannot be excluded.
65 2021-01-16 thinking abnormal, feeling abnormal 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 feeling abnormal Moderna Covid-19 Vaccine EUA - Severe dizziness, violent vomiting, fatigue. Foggy brain and felt ho... Read more
Moderna Covid-19 Vaccine EUA - Severe dizziness, violent vomiting, fatigue. Foggy brain and felt horrible. Could not turn head without extreme dizziness which lead to vomiting. Could not move for 20 hours. Slept all day. Called doctor twice - prescribed Meclizine. - 12.5 mg. Could eat or keep down liquids. Took Tylenol every 4 hours. Starting improving morning of 1/18/21. Still having improved dizzy spells as of 0335 pm. Still sleeping but able to keep down food and liquids. Normal vitals throughout reaction. Can someone contact me about advice on the 2nd vaccine?
65 2021-01-18 anxiety Bronco spasms, racing pulse, anxiety Treatment was Xanax, nebulizer, prednisone
65 2021-01-18 loss of personal independence in daily activities 1/15/21 severe sore lt deltoid x 3 days. PM of 1/15, nausea and fatigue. AM 1/16 awoke with severe... Read more
1/15/21 severe sore lt deltoid x 3 days. PM of 1/15, nausea and fatigue. AM 1/16 awoke with severe chills and nausea. Thru 1/16 & 1/17 severe fatigue, dizziness, GI sx, w/ severe diarrhea. No fever, but chills and hot flashes persisted. I kept falling asleep. My typical activity was severely affected. Family had to care for me. I am a registered nurse, which helped prevent an ER visit. Benadryl and Advil were minimal help. These symptoms were not mild. Moderate to severe
65 2021-01-19 impaired work ability Initially kind of soreness in right arm, (left handed). Sunday, head started hurting, started having... Read more
Initially kind of soreness in right arm, (left handed). Sunday, head started hurting, started having body aches, stomach ache. Then it moved to both arms, and entire body, nauseous. By Monday, really getting worse and at night extremely uncomfortable and not wanting to get up in the morning. Tuesday, off work and still having symptoms throughout the day. Went to the chiropractor and stated she was tight. Also got PT and said the same thing, she was very tight in her muscles. Today, Wednesday she's feeling better. Called employee health and notified them.
65 2021-01-19 sleep disorder Late onset ..day 8 after injection..localized site reaction so far with redness size of tennis ball ... Read more
Late onset ..day 8 after injection..localized site reaction so far with redness size of tennis ball and severe itching.
65 2021-01-20 insomnia Initially 102 degrees fever that lasted from 1/18/2021 5:00pm to 1/20/21 9:00pm. On 1/19/2021, pain... Read more
Initially 102 degrees fever that lasted from 1/18/2021 5:00pm to 1/20/21 9:00pm. On 1/19/2021, pain on left arm that over time went up to my shoulder to neck and now down to right arm. Currently neck and right arm hurt more than injected arm. Pain feels muscular and nerve like (similar to when I had shingles). Pain is not relieved by Lidocaine 1% patch or with Ibuprofen or Tylenol. I am not sleeping and am in pain all day.
65 2021-01-21 disturbance in attention 30 seconds after receiving the vaccine, I experienced dizziness, and difficulty concentrating, which... Read more
30 seconds after receiving the vaccine, I experienced dizziness, and difficulty concentrating, which lasted 40 minutes.
65 2021-01-22 sensation of foreign body Sneezing fit for 10 minutes, nasal congestion, upper lip became slightly puffy and got a feeling of... Read more
Sneezing fit for 10 minutes, nasal congestion, upper lip became slightly puffy and got a feeling of a lump in my throat. Subsided over a couple hours.
65 2021-01-22 sleep disorder Enable to make sleep headaches ,GI,elevated temp.and extreme fatigue ,rapid heartbeat
65 2021-01-23 disturbance in attention nausea, couldn't get out of bed, couldn't concentrated, couldn't walk, exhausted 7pm 1/6/21 til 1/8/... Read more
nausea, couldn't get out of bed, couldn't concentrated, couldn't walk, exhausted 7pm 1/6/21 til 1/8/21
65 2021-01-24 impaired work ability 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 2021-01-24 sleep disorder 1. swelling, redness, heat, itching at injection site. Lasting 10 days. Peak discomfort at day 8. ... Read more
1. swelling, redness, heat, itching at injection site. Lasting 10 days. Peak discomfort at day 8. Hard lump, hot to touch, red, strong itch. Was 3 inches by two inches. The arm is now back to normal. .2. Day 8. Woke at roughly midnight with extreme heat and burning in all toes. Quite painful. Very unusual, as I have never experienced anything like this before. When pain and burning became overwhelming I took Tylenol. It helped and I was able to sleep. The next morning the pain and burning were gone but my toes were, and continue to be quite numb, as is the area of my feet that surrounds my toes. I can't fully feel my socks, shoes, sheets, etc. It feel like I have cotton stuffed in my shoes. It is hard for me to related the level of heat, burning and pain that happened. I felt like I could melt a block of ice with my feet. It was severe. I marked "disability or permanent damage" below because I don't know if the nerves in my feet will return to normal.
65 2021-01-25 excessive sleepiness Day 2, a little pain at injection site. Day 4, I found an itchy hard lump was underneath the band... Read more
Day 2, a little pain at injection site. Day 4, I found an itchy hard lump was underneath the bandaide at the injection site. The lump was hot, bright red, and it was the same size as a mosquito bite. The lump went after 2 days. I did not do any treatment. I have been very tired since the injection, and I have to sleep 3-4 hours during the daytime. I do not normally have to take a nap during the day. I am still very tired and am sleeping a lot since the injection. Normally I am very active during the day.
65 2021-01-26 feeling abnormal Shortly after injection I got hot, foggy, felt like tongue was swollen. Had problems swallowing. ... Read more
Shortly after injection I got hot, foggy, felt like tongue was swollen. Had problems swallowing. I was scared, but said nothing. It only lasted a few minutes. About after an hour of being home, I had an issue swallowing only once. I don't know if adverse reaction, or panic attack. I have my 2nd dose schedule for the beginning of Feb I will let them know what happened. Also, quarter size red spot on right arm. It hurt when touched. Lasted a couple days.
65 2021-01-26 impaired work ability chills, body ache, fever (missed a day of work)
65 2021-01-26 sleep disorder Severe muscle pain ( mostly middle back) lasted 2 days Red swollen arm with bruising started as b... Read more
Severe muscle pain ( mostly middle back) lasted 2 days Red swollen arm with bruising started as baseball size and got to softball size. The redness is still on going with itching and redness in certain areas. ( it is still present at this time) NO pain or hard area. Trouble breathing while sleeping 1/13 AM. Woke me in the night and had to get out of bed. After a hour or so it subsided.
65 2021-01-27 feeling abnormal Severe nausea and vomiting,chills, fever,body aches...I had to stay in the bathroom all day sat., no... Read more
Severe nausea and vomiting,chills, fever,body aches...I had to stay in the bathroom all day sat., nothing would stay down...my body has never ever convulsed so hard to try and get something out of it... Sun .morn. still aches ,fever 101.6 my normal is 97.5...diarrhea all morning...very weak my injection site is sore...my nose has what looks like blisters all around both nostrils and lips have blisters...very tender...very swollen. ..I was able to keep water and food down...mon. still have fever until tues. Still ache all over...my nose seems very inflamed..mon more it was like a pocket of pus came out the left sinus...I had been putting Abreva on and into my nose.and switched to bacitracin...the swelling in my nose has gone down but the blisters are very noticeable...it is Thursday and I am finding myself out of breath on exerting myself and my whole body feels very drained, tired even though I have been getting more sleep...my left arm where the injection was feels like it has been punched .not sore ,not red.just Tha after effects of a punch...I am still putting Bacitracin on and in nose...my 02 stats have not been low at all
65 2021-01-27 nervousness Reported feeling jittery and nervous, overall just "not feeling right". Hypertension.
65 2021-01-28 anxiety, feeling abnormal, nervousness RECEIVED 1ST VACCINE 1/13 ABOUT 45 MINUTES LATER FELT LITTLE BRAIN FOG BUT WENT AWAY. ARM WAS LITTLE... Read more
RECEIVED 1ST VACCINE 1/13 ABOUT 45 MINUTES LATER FELT LITTLE BRAIN FOG BUT WENT AWAY. ARM WAS LITTLE IRRITATED. ON FRIDAY 1/22 WOKE UP TO INJECTION SITE ITCHY, BEET RED,HOT WITH HARD WELT LIKE AREA ABOUT 1 1/2 INCH ROUND WHICH SPREAD THROUGH DAY NEXT DAY LATE AFTERNOON STILL IRRITATED BUT FLATTENED OUT. TODAY 1/29 AREA IS STILL LARGE BUT FLAT COLOR PINK AND SORE.SECOND VACCINE SCHEDULED FOR 2/10/21. LITTLE NERVOUS AND CONCERNED WITH ANXIETY OF UNKNOWN IF SAFE TO RECEIVE OR OUTCOME. READ ONLINE REGARDING SIDE EFFECTS NOT SURE AT TIME WHAT TO EXPECT . ON 1/22/21 I DID CALL CDC NUMBER PROVIDED AND JUST LEFT MY NAME AND PHONE NUMBER ON VOICE MAIL DUE TO HIGH VOLUME. HAD NO RESPONSE.
65 2021-01-28 sleep disorder My arm is swollen, red and warm. It?s been hurting so much I couldn?t lift it. It?s even swollen und... Read more
My arm is swollen, red and warm. It?s been hurting so much I couldn?t lift it. It?s even swollen under my arm. For 48 hours i was exhausted and didn?t eat. My arm is still sore but I?m back to eating. Advil has worked well. The only time it?s hard is trying to go to sleep and get comfortable.
65 2021-01-29 anxiety I felt anxious after the shot, but that night felt ok. Morning was another story. I woke up with pai... Read more
I felt anxious after the shot, but that night felt ok. Morning was another story. I woke up with pain in my muscles from the waist down and found it difficult to walk. My eyes started to hurt. I had blurred vision. Around 2:00 I went by the mirror and saw that my eyes were blood red. I laid down and rested. About 2 hours later I got up the most of the redness was gone but then I had a headache. The next morning a persistent cough and the sneezes started. The headache would return every time that I coughed or sneezed. It was very painful- as if someone hit me with a hammer. Even though the pain only lasted a few minutes, it hurt a lot. I sneezed and cough a lot. Finally, Sunday morning I was walking better; however, I felt I had the flu. Normally, I would have gone in and got ready for a sub, but I wasn't able to. I rested on the couch. Then took a 2 hour nap. Finally, I felt better around 6 pm except for the painful headache that returned every time I coughed or sneezed. It has been a week. I thought the worse would be over by now. I guess I will have to go in and talk to my doctor on Monday because the sneezes and coughs are still quite painful. When will it end?
65 2021-01-29 sleep disorder Maybe be completely insignificant...one week after I received the vaccine, my left shoulder in which... Read more
Maybe be completely insignificant...one week after I received the vaccine, my left shoulder in which I received the vaccine started itching and itched for 24-30 hours. I believe it itched enough to disturb my sleep moderately. The next morning I took a single zyrtec and either due to time or the effects of the antihistamine, my shoulder stopped itching. My shoulder did NOT become red or show a rash. It is probably insignificant and may be normal for the general population but of all the shots I can remember and I receive a flu vaccine every year, I never had my arm itch significantly near the shot date or after. It was not a significant event, but I report it just in case this is unusual.
65 2021-01-30 anxiety H/O anxiety & HTN- felt anxious and hot. D/C calm and seemed fine.
65 2021-01-30 feeling abnormal I felt a sensation immediately after the injection. Ten minutes later I began to feel fuzzy but not... Read more
I felt a sensation immediately after the injection. Ten minutes later I began to feel fuzzy but not that noticeable. The left muscle in my left side of my neck stiffened. As we left the area and headed down the street I was getting anaphalactic: numb jaw, swelling tongue, closed throat, eyes closing, inner cheeks numb - as if I was severely novacained from the dentist. I was able to breathe ok to get home hoping it would pass and drank wanter to keep things fluid. I was there for one hour. On advice, I went to the ER to get checked out.
65 2021-01-30 nervousness 10 minutes after the Moderna vaccine, she felt shaky, dizzy and dry mouth. Her tongue felt slightly ... Read more
10 minutes after the Moderna vaccine, she felt shaky, dizzy and dry mouth. Her tongue felt slightly large. She was given Diphenhydramine. She rested an additional 20 minutes and was able to go home. Her husband drove her home. She is ok 3 hrs later.
65 2021-01-31 mental impairment, feeling abnormal Felt Wobbly & clumsy while walking 30 minutes into receiving shot. My brain felt compromised in it's... Read more
Felt Wobbly & clumsy while walking 30 minutes into receiving shot. My brain felt compromised in it's thought process struggling to think straight 30 minutes into receiving shot. Eyelids felt so heavy . I struggled to hold my eyes open but could not. Fell into a 3 hour deep sleep. Woke up feeling foggy brained & clumsy. At 3am the next day my throat felt thick & dry with difficulty swallowing. Went to ER at 3:30. Was told my tonsils were swollen. I did not have a sore throat. Dr tested for strepp throat with negative result. I was given a shot of benedryl & an oral Allegra pill. Symptoms began to subside & I was sent home. Nasty headache & wobblyness continued through the day & into the following day. Started feeling better Sunday night
65 2021-02-01 feeling abnormal chills, fatigue, fuzzy brain, soreness at injection site lasted 36-48 hours
65 2021-02-01 nervousness 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 2021-02-01 sleep disorder First I had a burning feeling on my face which began in the afternoon. By bedtime I was hurting all ... Read more
First I had a burning feeling on my face which began in the afternoon. By bedtime I was hurting all over, terrible headache and could not sleep. I developed a rash, pain, swelling and heat over injection area that was about 6 inches round. I also began to have ringing in my right ear and pain in the right side of my head. All of the symptoms persisted for over 48 hours and as of now four days later I remain with severe ringing in my right ear.
65 2021-02-03 impaired work ability, loss of personal independence in daily activities Day 4 post vaccination, onset of severe acute shingles progressing to multiple dermatomes over sever... Read more
Day 4 post vaccination, onset of severe acute shingles progressing to multiple dermatomes over several days; dermatomes L1, L2, L3, and T8, T9 Disabled currently from work and all ADL's since Friday 1/29. Projected to be out of work through 2/21.
65 2021-02-03 sleep disorder, impaired work ability Beginning 12 hours after the shot, I started having chills. My upper left arm (the injection site) w... Read more
Beginning 12 hours after the shot, I started having chills. My upper left arm (the injection site) was also sore which made it hard to sleep. These symptoms continued through the night. The next morning I had severe fatigue and had to call in sick to work. This continued all day and into the next night (36 hours after the shot). Overnight (40 hours after the shot) I had a low-grade headache. After 48 hours most of these symptoms subsided. Right now (54 hours after the injection) my arm is still slightly sore.
65 2021-02-04 feeling abnormal On 1-27-21 in the afternoon her mouth felt "tingly" and at around 5p.m. patient felt pain in arm. an... Read more
On 1-27-21 in the afternoon her mouth felt "tingly" and at around 5p.m. patient felt pain in arm. and the arm swelled. it also hurt for her to mover her arm. She also felt fatigued and she rested the rest of the evening. The next day she also felt fatigued. Her arm felt warm to the touch. She also had a headache and felt "spacey." She took a Benadryl to see if it would make her feel better. Today (Feb 5, 2021) she noticed redness at 2 p.m. around the site of injection and it looked a little "rashy." Patient applied Vaseline intensive care to rash. She says it still feels warm to the touch.
65 2021-02-04 feeling abnormal 2x3" rash at injection site, Covid-arm. Slight headache, brain fog, achy feeling and balance is off... Read more
2x3" rash at injection site, Covid-arm. Slight headache, brain fog, achy feeling and balance is off. Tiredness. Eye pain.
65 2021-02-04 insomnia Myalgia, Fever FATIGUE, RIGGERS, INSOMNIA Narrative:
65 2021-02-04 loss of personal independence in daily activities 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 2021-02-05 loss of personal independence in daily activities sore arm and minor rash about 2 inches by 3 inches next day, itchy 2/2/2021 rash extended from top t... Read more
sore arm and minor rash about 2 inches by 3 inches next day, itchy 2/2/2021 rash extended from top to inside shoulder to 8" down arm stabbing pain, red border 2/2/2021 8 am woke with severe dizziness. Could not turn head or sit up. with help, I was able to sit up by 11 a.m. could not walk one step without assistance from two people 6 pm able to maneuver 5 steps to bathroom with aid from one person grabbing door jam, furniture, toilet 10 pm able to maneuver to bathroom unassisted 2/3/2021 8 am able to walk using walls on side of hall or anything that could provide stabilization 2/4/2021 8 am able to walk 10 feet without assistance, but still wobbly balance improved over the day 2/5/2021 8 am able to walk without assistance, very carefully
65 2021-02-06 insomnia 25 mins post vaccine outer rim of Left ear became warm, itchy and turned red for approx 1 1/2 in in ... Read more
25 mins post vaccine outer rim of Left ear became warm, itchy and turned red for approx 1 1/2 in in length. Redness continued to spread toward inner part of ear for about 30 more mins. Woke with redness on 2/4. I applied topical Benadryl on 2/4 and 2/5. Redness resolved on 2/6. Other sides effects on 2/3: soreness at injection site, chills during night and difficulty sleeping. Took 1 Tylenol at 5:30 pm and 1 at 11:59 pm. Side effects on 2/4 : low grade fever (99.2 - 2+ degrees for me), fatigue, general feeling of un-wellness. All resolved by 2/5 except red ear, and fatigue which continues mildly today 2/7.
65 2021-02-08 hallucination, excessive sleepiness, mental status changes Diffuse muscle pain and tenderness, fatigue, hypersomnia, altered mental status, hallucinations.
65 2021-02-08 excessive sleepiness fatigue, muscle pains, hypersomnia
65 2021-02-08 sleep disorder I had the shot at 12:30pm. I went bed about 10pm, and woke up to my right arm having a series of ti... Read more
I had the shot at 12:30pm. I went bed about 10pm, and woke up to my right arm having a series of tiny shooting pain tingling (at specific spots, as if it were a pin prick traveling up and down my arm; pinging randomly across the arm). This was accompanied by an extreme desire to scratch/itch my arm where the pin pricks were being felt. I found myself scratching my arm in my sleep. There didn't seem to be a discernable rash of any color, but by the next day, i was seeing slight welts at various points along my upper and lower outer arm. I would feel a sharp pin-prick/tingle and instantly would feel the urge to scratch it. The scratching continued -- but not consistently. Sometimes for an hour or two at a time, seemingly coming out of no where. The arm was fine and then I'd wake up or be jolted by the sharp pin prick accompanied by the insane desire to scratch my arm. These 'spells' of tingling and itching have continued until today (one week and one day after getting the #2 Moderna shot. I have managed this with Benedryl (it worked by addressing the itching somewhat and provided relief from the tingling - it made me sleepy); anti-itch creams (soothed the skin topically), ice (to take the sting/itch sensation away) and calamine lotion (didn't really work). Tonight (1/8/2021 I cannot sleep. Although the itching and sensations seem to be intermittent, I have woken up the last couple of nights with intense itching and tingling to the point I couldn't sleep Usually Benedryl calms everything down, but tonight it isn't helping at all and I am crawling out of my skin. I have not gone to my Primary Care Physician, but will call and go in tomorrow.
65 2021-02-09 feeling abnormal After a week, red raised spot near injection site, slightly itchy. Skin felt funny there too. Sligh... Read more
After a week, red raised spot near injection site, slightly itchy. Skin felt funny there too. Slightly hard spot.
65 2021-02-09 feeling abnormal pt is experiencing fever, extreme cervical spine pain, chills, brain fog , extreme thirst, sore thro... Read more
pt is experiencing fever, extreme cervical spine pain, chills, brain fog , extreme thirst, sore throat
65 2021-02-10 loss of personal independence in daily activities, sleep disorder Over 24 hours of dizziness, headache, burning spine, muscle and joint pain, nausea, couldn't move ar... Read more
Over 24 hours of dizziness, headache, burning spine, muscle and joint pain, nausea, couldn't move arm, unable to sleep the night of injection, non functional the day after
65 2021-02-11 feeling abnormal, disturbance in attention During the sit after the shot I started feeling very relaxed. Went to work arrived at 11:45am. then ... Read more
During the sit after the shot I started feeling very relaxed. Went to work arrived at 11:45am. then started feeling almost like I was on a weak muscle relaxer (all over feeling) Started having trouble concentrating on my work. Having a little issue composing messages, Started doubting my work (I'm a bank teller). The store called me around 4:30pm, told what was going on, she told me to home and report. I left work at 6:15...by then things started to settle down.
65 2021-02-11 sleep disorder Went to bed at 9 pm feeling fine. Awoke at 3 am feeling feverish, excrutiating headache, joint pain ... Read more
Went to bed at 9 pm feeling fine. Awoke at 3 am feeling feverish, excrutiating headache, joint pain so intense I could not walk, body aches, cough. Pain so intense, could not get back to sleep. Tried wet towel to head, did not help. Took Tylenol, finally took edge off pain enough I could go back to sleep. Awoke some time later drenched in sweat. Finally got back to sleep, woke up in the morning feeling feverish and all the same symptoms except no cough. Used icepack and wet towel to no aavail. Unable to eat breakfast or drink coffee until took more Tylenol.
65 2021-02-13 confusional state Three hours after vaccination, numbness in tongue, unable to recall common words during conversation... Read more
Three hours after vaccination, numbness in tongue, unable to recall common words during conversation. Numbness in both hands, Confusion, lightheaded but not dizzy.
65 2021-02-15 anxiety I felt hot shortly after getting the vaccine. I do get hot flashes on occasion, so I attributed it... Read more
I felt hot shortly after getting the vaccine. I do get hot flashes on occasion, so I attributed it to that plus I was a bit anxious. After the 15 minute wait, I proceeded to my car. When I removed my mask, I saw that my cheeks and nose were very red. By the time I arrived home (about 30 minutes after being vaccinated) the redness had gone down considerably. I did not even know that this was considered an adverse effect until I saw it online a few weeks after my vaccination.
65 2021-02-15 feeling abnormal Extreme shivering from being cold almost convulsive,fever, headache, nausea with dry heaves, fatigue... Read more
Extreme shivering from being cold almost convulsive,fever, headache, nausea with dry heaves, fatigue. Arm was sore and slightly swollen. At about 4 hours after I smelled smoke and dirty dish rag smell. That didn't last. Other symptoms started 12 hours after given shot. It was immediate like turning on a light switch. I slept until 5:30 the next day, 2/3/2021. Was able to eat a bit of soup and went back to sleep until next morning. I was able to go to work on 2/4/2021 but experienced some weird brain fog and fatigue. On 2/5/2021 my arm had a large red ring around injection site and hives below it. I remained fatigued and lack of appetite for 4 days or so.
65 2021-02-15 hallucination 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 loss of personal independence in daily activities Three days after receiving the first dose of the COVID vaccine I developed severe radiating low back... Read more
Three days after receiving the first dose of the COVID vaccine I developed severe radiating low back and leg pain and inflammation and pain in my right knee . I also developed a persistent pain in my right hand and thumb along with "trigger finger" type symptoms in my hand where it clenches up and I cant open my hand up without using force. At times the pain is so bad I am unable to walk normally and also unable to utilize my right hand to open or hold things. In the 22 days that have passed since the shot the symptoms have not subsided and are effecting my ability to get around and carry my normal activities of daily life.
65 2021-02-15 restlessness 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 2021-02-15 sleep disorder Very itchy rash at vaccination site - 4-5" in diameter. By the second day is was red, somewhat hard,... Read more
Very itchy rash at vaccination site - 4-5" in diameter. By the second day is was red, somewhat hard, and very hot, and so itchy that I couldn't sleep. By the fourth day (today) it seems to be getting a little better.
65 2021-02-16 feeling abnormal Patient felt funny. Onsite EMS was called vitals were taken BP 108/68 98% O2 room air BG 108 HR 72.... Read more
Patient felt funny. Onsite EMS was called vitals were taken BP 108/68 98% O2 room air BG 108 HR 72. General Malaise unknown cause patient refused evaluation/care. Left aginst medical advice.
65 2021-02-17 disturbance in attention Twelve hours after injection I experienced 18 hours of symptoms making me bedridden. Fever, Severe M... Read more
Twelve hours after injection I experienced 18 hours of symptoms making me bedridden. Fever, Severe Muscle Aches, Severe Joint Pain, Headache, Weakness, Difficulty concentrating. I took no medication for these symptoms. They subsided after 18 hours, gone.
65 2021-02-17 feeling abnormal "THROWN HER BODY IN A LOOP."
65 2021-02-17 sleep disorder Actually had 2 adverse events, #1 on the night of the vaccine.had terrible heartburn,which i never ... Read more
Actually had 2 adverse events, #1 on the night of the vaccine.had terrible heartburn,which i never get,that started in my sleep ,and literally woke me up in the middle of the night.Also alot of gas and burping. Lasted about a day. # Midweek,as I reported. about the wed after receiving first dose friday AM, I started having dry mouth and extremely dry lips, and continuous thirst. Didnt have to drink much, but continued recurring over the course of one and a half to 2 weeks, until finally disappeared. I was advised by one of my physicians to put real lemon juice on tip of tongue to stimulate the salivary glands.That really helped. did hear that this happened to several other patients.
65 2021-02-18 confusional state 1)fever, chills, body aches, nausea, diahrrea, headache 2) fever, chills, body aches, nausea, diahr... Read more
1)fever, chills, body aches, nausea, diahrrea, headache 2) fever, chills, body aches, nausea, diahrrea, confusion, headache, swollen glands, cough, ear aches, night fevers
65 2021-02-18 insomnia Chills, headache, sweating, fatigue, can?t sleep
65 2021-02-19 anxiety PT was SOB after vaccine, seemingly related to anxiety.
65 2021-02-19 sleep disorder On the second day of receiving the shot my arm began to feel heavy, I had a pain in my back around ... Read more
On the second day of receiving the shot my arm began to feel heavy, I had a pain in my back around my shoulder blade, that went around my side near my breast, the area was swollen, the pain then went from my shoulder down to my elbow. It felt like gas, so I had someone on week 2 to press the areas that was hurting. I felt the pain move about so I took 3 antacid (tums). I ate a sandwich and soup, needed to use the bathroom, which I did and passed gas, the area went do to the size of my right side, I thought it was better but not so. I have been awaked 3pm with my arm hurting , a feeling as if it needs to pop, or something needs to move or be released. It's been 3 weeks now. I've also noticed the nerves in hand were tingling constantly.
65 2021-02-20 feeling abnormal Immediately felt like I couldn?t think normally... weird brain fog, sudden urge to sleep. Figured it... Read more
Immediately felt like I couldn?t think normally... weird brain fog, sudden urge to sleep. Figured it was no big deal but over the next day it got worse, fever and chills, then severe headache, stiff neck, swollen lymph nodes, cognitive impairment... it made me feel like I was never going to get my ability to think normally back. The stiff neck kept getting worse until I could hardly turn my head, brain fog and swollen lymph nodes were severe and lasted three weeks. It was severe enough that I knew it would be a bad idea to get the second dose. Finally I got better. I know of no one who had such an extended period of feeling quite ill. When I first had lyme disease I had an encephalitis. These symptoms were quite similar despite the fact that my Lyme disease is well controlled with medication.
65 2021-02-20 feeling drunk, mental status changes 1 hour post vaccine: drunken state, headache 24-48 hours post vaccine: headache, fever 120 hours po... Read more
1 hour post vaccine: drunken state, headache 24-48 hours post vaccine: headache, fever 120 hours post vaccine: unresponsive and altered mental state
65 2021-02-21 anxiety, poor quality sleep I had headache, chills, sore throat, shortness of breath, fatigue, anxiety & couldn't sleep well for... Read more
I had headache, chills, sore throat, shortness of breath, fatigue, anxiety & couldn't sleep well for 2 nights. the next day I was mostly better, but on day 3 on got sick again with sore throat & fatigue. I am very concerned about taking the next dose.
65 2021-02-21 confusional state Pt states she awoke during the night and was very confused. Pt became incontinent and had unsteady g... Read more
Pt states she awoke during the night and was very confused. Pt became incontinent and had unsteady gait. Pt was taken back to bed by husband. Duration of event took about 15-30 minutes. Pt states she has never had these symptoms in the past and has not experienced these symptoms since the event.
65 2021-02-22 feeling abnormal, agitation About 6 PM the day I received the vaccine, the arm started to become extremely sore. It was achy fee... Read more
About 6 PM the day I received the vaccine, the arm started to become extremely sore. It was achy feeling and it radiated down to my wrist. This lasted until Sunday and it started to fade. Today it is just some soreness left at the injection site. I was taking OTC Acetaminophen 500MG between 100 MG for pain. It was difficult to sleep due to the pain. I was also putting cool compresses on it. The pain worse when I was trying to clean my car and shovel the snow. However the cold compress and stretching did help with some of the pain. I also felt agitated for different periods times after vaccination, I felt like my hormones were out of whack and I wanted to "bite someone's head off" this lasted for about an 1 hour or so. I also had mild headaches.
65 2021-02-23 excessive sleepiness Extreme fatigue for 4 days, sleeping deeply and continuously for 10-12 hours (sleeping thru alarms),... Read more
Extreme fatigue for 4 days, sleeping deeply and continuously for 10-12 hours (sleeping thru alarms), waking briefly, uncontrollable urge to go back to sleep thru 3rd day, then able to be up for a few hours then back to sleep. Only other side effect very sore arm and stiff neck 1st 48 hrs.
65 2021-02-24 disturbance in attention Nearly continuous headache behind the eyes since the evening of vaccine shot (11 days as of current... Read more
Nearly continuous headache behind the eyes since the evening of vaccine shot (11 days as of current date). Sometimes dull throb, sometimes sharp pain usually on left side (same side as vaccine shot). Sensitivity to light. When pain is sharper causes indigestion and nausea. Pain goes away if I take ibuprofen, but always returns and persists overnight. I don't like taking ibuprofen or acetaminophen more than once a day or for continuous days. Acupuncture worked for a short time. Affects my ability to concentrate and work on computer or watch TV. What other natural treatment will help? How much longer will this last?
65 2021-02-24 feeling abnormal Red, hot, swollen area at shot site. Extreme itching and jittery, antsy feeling in body starting 2/2... Read more
Red, hot, swollen area at shot site. Extreme itching and jittery, antsy feeling in body starting 2/24/2021 and this evening on 2/25/2021 it is slightly worse with a bigger and redder lump and much itching. The nurse advised me to take two zertec and apply hydrocortisone cream which o have done. Applied the cream many times today.
65 2021-02-24 excessive sleepiness Terrible headache, horrible body aches, felt exhausted, slept for 18 hours
65 2021-02-25 insomnia, impaired work ability First, extreme upper arm discomfort after nursing student had difficulty stopping the bleeding. The... Read more
First, extreme upper arm discomfort after nursing student had difficulty stopping the bleeding. Then, within 5 minutes, felt somewhat dizzy as pain radiated across shoulder, up spine and neck, into jaw and right ear. Then, horrible jabbing pain under shoulder blade, followed by a feeling of extreme compression from site of injection to wrist. Checked every 10 minutes or so by nurses for 50 minutes. They said that redness first was up arm then down arm. Once light headedness improved, I left for work (remote teaching from home). By 3:20, I found it hard to focus, the throbbing under my shoulder and compression feeling of my arm increased with diminished feeling in right hand. Usually 97.2 temperature but ran low-grade temp of about 99 degrees for 3 to 4 days. Sleepless night first night with increased pain and discomfort, i.e., no new symptoms but all symptoms increase with difficulty turning neck and head. Area around injection warm for several days, with swelling first 24 hours, resolving over a few days; still dark black and blue today, 8 days later.
65 2021-02-26 disturbance in attention numbness, tingling, and twitching of lower lip, left side; infection at injection site; clumsiness w... Read more
numbness, tingling, and twitching of lower lip, left side; infection at injection site; clumsiness when walking; difficulty enunciating words; EXTREME burning, tingling , and numbness of fingers and hands; difficulty concentrating; significantly increased neuropathy pain in hands and feet. ALL symptoms are continuing 2 weeks AFTER injection. I sent a message to my Primary Physician but haven't received a response yet.
65 2021-02-26 fear 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 2021-02-27 anxiety On 02/27/2021, Patient received dose #1 of Moderna COVID vaccine at 12:00 p.m. at COVID Vaccine POD.... Read more
On 02/27/2021, Patient received dose #1 of Moderna COVID vaccine at 12:00 p.m. at COVID Vaccine POD. Prior to vaccination, the pt. reported a history of anaphylaxis to shellfish and is prescribed an EPI Pen, she was instructed to wait 30 minutes after vaccination for monitoring. At 12:11, patient reported feeling anxious, tingling lips, and numbness around her mouth to nursing staff. On assessment, BP 150/80, resp. 20. Patient then reported her tongue was getting "thick". Staff continued to monitor symptoms, patient stated symptoms were not improving and her tongue continued to be getting "thick" At 12:15, EPI pen auto injector was administered in patient's right vastus lateralis. 12:27 EMS arrived, patient was assessed, symptoms had resolved, and she refused to be transported to the ER. Follow up instructions were given by EMS and patient was cleared to go home accompanied by her husband.
65 2021-02-27 feeling abnormal Chills first two night with headache, on Wednesday starting getting rash, it?s on my arms and right ... Read more
Chills first two night with headache, on Wednesday starting getting rash, it?s on my arms and right side of face and I?m miserable from the itching.
65 2021-02-27 sleep disorder Injection on Wednesday at 3 PM. No immediate reaction. However, a few hours after the shot my left ... Read more
Injection on Wednesday at 3 PM. No immediate reaction. However, a few hours after the shot my left arm (at the injection site) was sore and swollen. That evening it was painful and disrupted my sleep. The next morning (Thursday) I was somewhat feverish. By the mid-morning my fever was up to 100.4, and by the late afternoon it was up to 101.4. I felt exhausted -- too exhausted to even write an email. I had chills, backache, and slept nearly the entire day (~8 hours). Based on this, I would call this day a 4 in terms of severity. The next day (Friday), my fever had declined to 100.2 but was still elevated, but now I had a backache (lower back), and I was still weak. However, I could get out of bed for about 10 minutes without too much difficulty. I slept for about 5 hours during the day. This may also qualify as a 4. On Saturday, my fever had declined further to 99.4, and my energy level was somewhat better. Even so, most of the day was spent in bed, but I slept less during the day than on the previous days (about 3 hours). The main thing that was a problem on Saturday besides being weak was a headache. This is a strange thing because I rarely have had headaches in my life. This is a pounding in the front of my head, only occurring when going from an upright position into a seated or supine position. Most of the headache disappears in about 30 seconds. Overall I would say Saturday was a 3 in terms of severity. Today (Sunday) my temperature seems to be normal (98.6) -- though this is a full degree above what is normal for me. However, the headache has become worse -- it was hurting me while sleeping, and woke me up from the discomfort. I still have the backache, and I am still weak. It's only 6 AM here so I cannot comment on how the rest of the day will go.
65 2021-02-28 insomnia Starting the morning of March 1, almost 2 weeks after my first vaccine injection, I have a large sli... Read more
Starting the morning of March 1, almost 2 weeks after my first vaccine injection, I have a large slightly swollen rash area around the injection site which is tender to the touch. The only other reaction I have had is soreness around the injection site for the first 3 days after the initial injection which kept me awake at night.
65 2021-03-01 feeling abnormal Sore arm, slight muscular aches and headache with minimal fatigue began 9 hours after dose and becam... Read more
Sore arm, slight muscular aches and headache with minimal fatigue began 9 hours after dose and became profoundly exacerbated by the following morning (02/25/2021) with severe arm soreness, increased muscular discomfort, throbbing headache, severe fatigue, and general malaise all of which interfered with mobility. There was no fever or chills but I was cold and could not get warm and just felt lousy. The symptoms appeared consistent with a flu. These side effects began to dissipate slowly the following day (20/26/2021) and were completely resolved by 02/27/2021.
65 2021-03-01 feeling abnormal About 4 hours after second shot, headache, chills and body aches for 36 hours. Then felt fine for 1... Read more
About 4 hours after second shot, headache, chills and body aches for 36 hours. Then felt fine for 12 hours, and then the next 12 hours body sweats all night and some diarrhea the next morning and a feeling of just not being right. I attribute this to flu like symptoms that everyone says is associated with Moderna shot 2.
65 2021-03-01 impaired work ability 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 2021-03-02 insomnia 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 2021-03-03 feeling abnormal, memory impairment 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 hallucination 1st vaccine - 12 hours after receiving the vaccine I got a metal taste in my mouth and extreme thirs... Read more
1st vaccine - 12 hours after receiving the vaccine I got a metal taste in my mouth and extreme thirst. Up all night. Body felt "electrified". 2nd vaccine - 4 hours after receiving the vaccine I got aches and pains. This progressed over the next several hours to: 1) my skin felt like it was on fire; 2) followed by chills and shaking; (all night); 3) hallucinations; 4) extreme fatigue to the point I felt like I was buried in cement and couldn't get out of bed to go to the bathroom. At one point I thought about calling an ambulance but my mind was unable to figure out how to do that. 24 hours after injection: 1) headache, mild body aches and some feeling of skin burning.
65 2021-03-03 insomnia severe arm pain so much that I could not lift my arm at all for 2 days, couldn't sleep, put on a coa... Read more
severe arm pain so much that I could not lift my arm at all for 2 days, couldn't sleep, put on a coat, reach for seat belt. Arm also had no strength. Finally took ibuprophen 600 and 800 mg doses to reduce swelling. 3 days out now I can lift arm halfway. just thought I should report. I hear dose 32 has more side effects but I will take it
65 2021-03-03 sleep disorder, restlessness, impaired work ability 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 2021-03-04 euphoric mood A few hours after receiving the first shot ... I felt Very Cold and tired~ went to sleep for a few h... Read more
A few hours after receiving the first shot ... I felt Very Cold and tired~ went to sleep for a few hrs and lasted about 6 hrs after waking. Nest day was okay-just a little dizziness. Third day brought on more symptoms: eyes burning, little dizziness, neck hurt and I had a feeling like the flu ~ spaciness in my head and Very tired...stayed in bed all day. Next five days were normal. Then on following Wed (a week after the shot) a rash or hives formed around the injection area -was itchy. I felt sleepy & my head had a spaciness again. Stayed in bed all day, napped and this lasted about 10 hrs. This morning I feel better but very dizzy. And the 4' circle around injection is still noticeable.
65 2021-03-04 hallucination Patient reports she began hallucinating "brilliant colors" (neon) for about 4 hours. She was dizzy f... Read more
Patient reports she began hallucinating "brilliant colors" (neon) for about 4 hours. She was dizzy for about 24 hours. She developed a "big goose egg" at injection site and then one above it and one below it for a total of 3 "goose eggs". She then developed a rash. She reports as of 03/05/2021 the 2 goose eggs above and below the injection site have resolved and the one at he injection site has "gone down".
65 2021-03-05 disorientation Dizziness and tingling in arms/legs initially, abated within two hours. Fatigue, headache, burning ... Read more
Dizziness and tingling in arms/legs initially, abated within two hours. Fatigue, headache, burning eyes and slight disorientation for 12 hours after first dose of Moderna. No prior reaction/side effects from any vaccination.
65 2021-03-05 feeling abnormal I woke up with chills, fever 99.9 ,mental fog ,, headache and pain in my legs at 2 am Feb 28 whic... Read more
I woke up with chills, fever 99.9 ,mental fog ,, headache and pain in my legs at 2 am Feb 28 which continued until 4pm of the same day. Then the pain in my legs subsided but fever, chills , headache and mental fog continued until March 1 at about 1pm. At that point the only symptoms were mental fog and exhaustion.
65 2021-03-05 feeling abnormal When the registered nurse injected me, blood squirted out my arm in a stream. I thought that was st... Read more
When the registered nurse injected me, blood squirted out my arm in a stream. I thought that was strange. She asked me if I took blood thinners, I said "No," She put gauze on the injection site, held it there and then put a bandage on it. I told her this has never happened to me before ever when I took any shots in my arm. She said I would be alright and told me to wait 15 minutes in the parking lot which I did. That night, I had a slight fever, my arm felt like it was on fire and I had hot and cold chills and couldn't eat anything or I felt I would vomit. I felt the same way the entire next day and just felt miserable. I also had problems breathing all day. I had to use my inhaler every two hours with 3 or 4 puffs. This went all ALL day and in the evening. The second day (5th), I felt slightly dizzy and my arm still hurt and noticed a red rash but I could BREATHE finally with no problem!
65 2021-03-06 mental impairment 1st vaccine given on 2/20/21 @3:30 pm. On 2/21/21 around 12:30 pm I started feeling weak all over, d... Read more
1st vaccine given on 2/20/21 @3:30 pm. On 2/21/21 around 12:30 pm I started feeling weak all over, didn't feel I could move, both arms hurt in the bicep area to the shoulder. Was cold, tired and ran slight fever, not being able to function to do anything but lay around covered up ,sleeping. On Monday 2/22/21 I felt some better in am other than having an ear ache and sore throat, by evening my ear was hurting and I was again aching in both arms and weak. As the week went on I felt a little better each day. I continue even today to get tired easy. Hope not vaccine is not this bad.
65 2021-03-07 feeling abnormal very sore arm at injection site for 2 days. For 4 days had no appitite and felt nausous. I had chi... Read more
very sore arm at injection site for 2 days. For 4 days had no appitite and felt nausous. I had chills and night sweats and a low grade fever.I was tired and foggy and not myself.
65 2021-03-07 excessive sleepiness First vaccine was fine. With second, was fine til about 28 hours later, started to feel fatigued, t... Read more
First vaccine was fine. With second, was fine til about 28 hours later, started to feel fatigued, then low grade fever, body aches, chills, headache. 32 hours later, rash on arms, inner legs, belly. Slept a lot. Rash bumps went away over night, 40 hrs later had just red arms and body, light fever, headache, body / skin aches AND lymph node in neck , on injection side, swelled up and visible bump. Took benedryl ... hope tomorrow is better.
65 2021-03-07 excessive sleepiness I was awaken at approx 5:00am the morning following my 2nd Moderna Covid 19 vaccine with my upper l... Read more
I was awaken at approx 5:00am the morning following my 2nd Moderna Covid 19 vaccine with my upper left arm severly aching. The person who gave me the shot informed that if my arm hurt I could use a cold pack and take aspirin, which I did that morning. Approx 30 minutes after applying the cold pack, I became extremely cold and my entire body shivering. I wrapped up in a blanket and drifted in and out of sleep for about 5-6 hours, cold and shivering the entire time. When getting up to get water or use the restroom, my arms and legs were extremely weak and wobbly. I almost felt as if my legs would collapse under me when walking. I took my temperature throughout and it was at a normal level. Around 11:00am, the cold and shivering subsided but then I began to feel warm. I continued to take my temperature and it was continually climbing until it reached 103.2 degrees before beginning to reduce down. My weakness and wobbleness also continued and I had a severe headache. I also vomited 1 time. At approx 7:00pm, my temperature was back to normal and I began feeling a lot better. I have had no further symptoms since then.
65 2021-03-07 loss of personal independence in daily activities 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 disturbance in attention Pt feels fatigue, fever, chills, and is having trouble concentrating. PT claims that fatigue is jus... Read more
Pt feels fatigue, fever, chills, and is having trouble concentrating. PT claims that fatigue is just as bad, aches that are not severe, and is still having trouble concentrating. Took two advils the first day whcih helped with chills and aches, other than that nothing
65 2021-03-08 mental status changes 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 2021-03-09 anxiety Pt received her 1st dose of Moderna; waited 15 minutes in observation and left with hour spouse. Pt... Read more
Pt received her 1st dose of Moderna; waited 15 minutes in observation and left with hour spouse. Pt reports feeling the left side of her face felt numb. She was visibly shaking and had increased anxiety. Pt denied any other symptoms. She was taken outside for fresh air and educated on deep breathing exercises. Staff used distraction techniques, such as, music to assist. Pt VS BP. 212/116 P. 86 R.20 Temp. 98 Pt reports "I know Im working myself up". At 1650, Benadryl 25mg capsule PO x's 1 was given without further incident. Medication and distraction techniques effective. Pt and spouse was educated on when to call 911/EMS and V-Safe information provided. VS: BP 176/101 P. 63 R. 18 Temp 97.8
65 2021-03-09 sleep disorder 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 sleep disorder My left arm was sore after the injection exp red patch, hot to touch for 24 hrs. The level of pain i... Read more
My left arm was sore after the injection exp red patch, hot to touch for 24 hrs. The level of pain in my left arm kept me up at night.
65 2021-03-10 excessive sleepiness Extreme headache, chills, fever & overall body aches less than 24 hrs after vaccine...Took ibuprofen... Read more
Extreme headache, chills, fever & overall body aches less than 24 hrs after vaccine...Took ibuprofen, drank lots of water , slept a lot, symptoms were milder after 24 hrs-no chills, still mild headache & slight body aches, still taking ibuprofen & drinking plenty of fluids
65 2021-03-10 impaired work ability Moderna Covid 19 Vaccine EUA. My left arm was stiff and painful day of. Went to work. Pain was acro... Read more
Moderna Covid 19 Vaccine EUA. My left arm was stiff and painful day of. Went to work. Pain was across shoulders. Took Aspirin, Advil, Tylenol at various times. Went to doctor on 03/02/2021. I mentioned I had had Covid shot. Pain required lying flat and lifting arm above head. Was treated for clavicular ridiculous they and given muscle relaxer. A day or so with increased pain called for pain medicine. Mentioned again about Covid shot. Given Tramadol. No pain relief just dizziness and lethargy. Back to doctor on 03-09/2021. Gabapentin ordered and X-ray ordered. Some numbness on lower right leg. Pain down back of left arm in addition to other areas.
65 2021-03-10 loss of personal independence in daily activities, sleep disorder After 3.5 hours, the injection site got sore. By the next day, it was painful and swollen. By the ... Read more
After 3.5 hours, the injection site got sore. By the next day, it was painful and swollen. By the following day, it was 80 % better. After that, it seemed fine. About ten days later, I noticed that the injection site had become dense and a little sore. Within a few more days, I started having pectoralis muscle spasms, and I can no longer raise my right hand to my mouth, to my opposite shoulder or overhead. Trying to make those motions causes me to cry out in pain. I can't sleep on that shoulder, and need help getting dressed. I get acute pain from moving it in other ways, too.
65 2021-03-10 sleep disorder The morning of the 23rd of January began to feel the pain in my left shoulder. on Friday the 24th i... Read more
The morning of the 23rd of January began to feel the pain in my left shoulder. on Friday the 24th i scheducled an appointment with the urgen clinic. They have me a steroid shot and 5 days of prednisone. .. for pain PRN. I also used a warm press. However, at night i am awakened every few hours with anoying discomfort and pain. the pain seems to be radiating up and down my arm and my deltoid seems to be paining as well. this continued on. I contacted my doctor in california and we did a telehealth visit. he perscribed Naproxen 550 mg and an ointment. not much help. i got my second shot on the 22th of Feburary at a different health facility in Tx. I got it in my right arm. no issues at all. My left arm continue to bother me. I went to california and visited my urgent care facility. The provider told me she had seen this continued arm pain in clinic but nothing after 30 day or no one reported this problem. I have to sleep on my right side and put a pillow between my arm and my body. I just went to buy a sling to reduce the movement. I don't take perscribed medications. I don't have High blood pressure, diabetis or any other underlying condition. I went to the pharmacy and the pharmacist advised that i put in another adverse reaction as i had reported some time ago.
65 2021-03-11 feeling abnormal 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 2021-03-11 feeling abnormal 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 excessive sleepiness Severe vertigo for 16 hours , vomiting 12 times through the time, chills, couldn't get out of bed wi... Read more
Severe vertigo for 16 hours , vomiting 12 times through the time, chills, couldn't get out of bed without assistance (never happened to me before), slept for 20 hours
65 2021-03-12 disorientation, feeling abnormal During the night woke up with mild headache, took a Tylenol PM. Woke up, walked to kitchen then sudd... Read more
During the night woke up with mild headache, took a Tylenol PM. Woke up, walked to kitchen then sudden dizziness, nausea and sweating began. I sat in a chair and was unable to get up or pick up head for about 30 mins. (disoriented, semi conscious) Day after, (today) feels like after effects of a migraine episode I used to get. Very tired, low energy.
65 2021-03-12 insomnia 5:30 pm on day of vaccine: chills 7 pm: temperature up to 99 (usually 96.4) 8:30 pm: more severe chi... Read more
5:30 pm on day of vaccine: chills 7 pm: temperature up to 99 (usually 96.4) 8:30 pm: more severe chills, extremely achy in all areas of body (not just arm), could not get warm 12:20 took advil to deal with the aches 12:30 AM: could not fall asleep, started having stomach pains, vomited all of my last meal (eaten at 8:15) and continued to vomit with empty subject, temperature up to 100, severe chills. Next 2 hours: alternating between chills and sweats Aches have continued with residual nausea now 24 hours after shot
65 2021-03-14 disorientation 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 feeling abnormal, insomnia On Monday evening, I started feeling rather weird, rather out of it. During the night, I was having ... Read more
On Monday evening, I started feeling rather weird, rather out of it. During the night, I was having trouble sleeping and woke up with a fever of 100. I took Tylenol and went back to bed. When I finally got up probably around 10 a.m., I was not feeling well at all. I had body aches, a headache, stomach cramps, chills, fever, my arm was very sore, very tired, and exhausted. I fell back asleep early afternoon and woke up with a 101.7 fever. Took Tylenol & continued to not feel well. Went to bed around 10 p.m. and slept for 12 hours. Wednesday, I was still very exhausted, but not as many body aches. That evening, I noticed my face had many small pimples on it. The next morning, I woke up with a rash and redness around the injection area, a rash on my face and on other areas of my body, which caused itching/tingling sensations. I called the health department nurse and she indicated that the rash was also a side effect of the vaccine. She suggested Benadryl, but I mentioned that I don't handle that medication very well. I did use some Benadryl cream on my arm for the itching. Not sure whether the cream caused a reaction, but I once again became very tired and took a nap. I also developed a stuffed, clogged left ear, which affected my hearing. This sensation came and went several times from Thursday through Sunday. On Friday, I still had a rash and experienced some fatigue. When I woke up on Saturday, I finally felt like I was "normal" again.
65 2021-03-14 feeling abnormal 17 hours post injection I had terrible back pain!!! Preceded by headache, chills and fever. The pa... Read more
17 hours post injection I had terrible back pain!!! Preceded by headache, chills and fever. The pain was excruciating for six hours, finally relenting slowly. After six more hours, all effects but the brain-fog disappeared. Brain-fog lasted three days.
65 2021-03-14 excessive sleepiness Fever of 99.5 to 100.4, chills, fatigue, slept a lot, arm really sore
65 2021-03-14 sleep disorder Severe pain, extreme swelling, hives, redness in arm, armpit, and left breast. Pain continued to i... Read more
Severe pain, extreme swelling, hives, redness in arm, armpit, and left breast. Pain continued to increase over night. I applied cold compresses, and took Motrin and Benadryl. The pain was so intense that I was in tears. It would not stop. The pain went down my arm to my hand as well. I was unable to sleep. The swelling has gone down, but is still present. There is discoloration under the bottom of my upper arm, arm pit and breast. The pain is still awful when my arm is not in use, and increases when I do use the arm. I reached out to doctor's office and for two weeks I didn't receive a call back from anyone at the facility following almost two weeks of calling.
65 2021-03-15 insomnia Fever Insomnia Narrative: Other Relevant History:
65 2021-03-16 amnesia, disorientation Per patient, she said about 2 hours after receiving the shot she felt very: * disoriented * short... Read more
Per patient, she said about 2 hours after receiving the shot she felt very: * disoriented * short term memory loss She reports she had the same symptoms (way worse) when she had COVID infection last year. Per her provider she said they told her not to receive the 2nd dose.
65 2021-03-16 feeling abnormal Nausea first 2 days; Foggy head and headache first 2 days; Extreme tiredness first 2 days; Achiness ... Read more
Nausea first 2 days; Foggy head and headache first 2 days; Extreme tiredness first 2 days; Achiness first 2 days; Very sore arm for 1 week; Swelling, redness, fever and rash at/around site of shot on left arm lasting 3-4 days; Extreme constipation began 2 days after shot and lasted 4 days, followed by diarrhea for 2 days after that; overall duration of side effects lasted for one week.
65 2021-03-16 excessive sleepiness Body aches and pains, fever, headache, and inability to stay awake. 18-24 hours.
65 2021-03-16 loss of personal independence in daily activities Suddenly, 6 hours after receiving Dose 2 of the Moderna COVID-19 vaccine my injection site arm start... Read more
Suddenly, 6 hours after receiving Dose 2 of the Moderna COVID-19 vaccine my injection site arm starting hurting. I took 1000 mg Tylenol and went to bed. For the next 48 hours I remained in bed with major flu like symptoms: fever, chills, severe body aches every where, very bad headache and severe arm pain. I suppose the nausea I felt was due to taking 1000 mg Tylenol every 5-6 hours for 48 hours. Then as fast as all this came on it all seemed to go away after 48 hours. It was a long two days since I had major difficulty getting out of bed or caring for myself.
65 2021-03-16 nervousness, feeling abnormal Severe allergic reactions: Dizziness, tingling on my face and/or body and trembling. Wednesday: My a... Read more
Severe allergic reactions: Dizziness, tingling on my face and/or body and trembling. Wednesday: My arm started to feel slightly sore within minutes after the injection. On the drive home I felt allergic tingling in my body around the chest area on and off for a few minutes. I had a strong headache that would come and go that evening. An existing itchiness on my scalp from an allergy response to a new shampoo and other products became inflamed with excessive itchiness and redness all over my scalp. I felt light headed, too. Thursday: I woke up to an itchy scalp and tingling on my forehead. I felt very dizzy all day. I still had a strong headache that would come and go. I was lethargic and slept in the afternoon. My arm was really sore. I woke up at 11:30 p.m. very nauseous. I was able to prevent vomiting by laying a certain way in my bed. Friday: I am still dizzy but not as bad as Thursday. My arm felt better today. My body is experiencing a tingling feeling all over. It was a very strange sensation. I still had a strong headache that would come and go. Saturday: I had strong dizziness all day on Saturday. I felt awful. I called and reported my symptoms to Dr office. Sunday: My face was tingling in the morning. My left cheek felt puffy. My face is sensitive to touch. Monday: I woke up at 3:30 a.m. and my lips felt puffy but didn?t look puffy. Arms and chest looked a little pink. At 10:20 a.m. my face felt tingly. I was also shaky and a little dizzy. I called the doctor's office and left a message. Tuesday: I woke up with a headache and my scalp aching. My face felt tingly. There were some places on my face felt rough (sand papery) to the touch. I was still trembling. I had on and off dizziness. I made an appointment with the doctor for the next day. Wednesday: I had a video appointment with Dr. We scheduled me to have extensive bloodwork done the next day. I continued to experience tingling and trembling through February 27th. I felt bad for ten days. I have had occasional tingling up to March 17th.
65 2021-03-18 feeling abnormal 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 insomnia 8:00 PM, arm started to get sore at injection site, 9:00 PM started feeling body aches and fatigue... Read more
8:00 PM, arm started to get sore at injection site, 9:00 PM started feeling body aches and fatigue. 11:00 PM had fever, chills, shaking, and more body aches, headache. The nerves in my back feel sensitive like happens with shingles but shingles only break out on the back of my thighs. By 2:30 AM felt terrible, couldn't sleep, took Tylenol and bundled up. Finally stopped shaking and got warm. By 6:30 AM fever seemed to have broken but body aches and headache continue. Took Tylenol at 6:30 AM, 10:30 AM. Feeling somewhat better but still have body aches and injection site soreness. Have I recovered? Not yet, not completely but going in right direction.
65 2021-03-18 sleep disorder Woke up with severe chilling and severe muscle aches. Unable to get back to sleep. Also very tired ... Read more
Woke up with severe chilling and severe muscle aches. Unable to get back to sleep. Also very tired all day.(usually not that tired even with 4 hours sleep.) No appetite. Lasted 24 hours.
65 2021-03-19 excessive sleepiness Eight hours after receiving my second shot I began to feel bloated and like I had mild food poisonin... Read more
Eight hours after receiving my second shot I began to feel bloated and like I had mild food poisoning. During my sleep, after 11pm, I was awakened by an intense headache. I was fatigued and didn't want to go and get ibuprofen. I probably didn't take that for several hours. Then I took 600mg; about 3 hours later, 400mg; 400mg 3 hours later and another 400mg about 3 hours later. The headache was still intense, although diminished. I had body chills and intense heat, which normally would bother me, but not this time. I awoke at 11am but slept throughout the day. I next ate food -- a bowl of plain pasta -- about 7pm. I still had a headache and nausea. I went back to sleep, waking at 6am. My headache subsided; my digestion was mildly irritated. About mid afternoon took a short walk and felt fatigue afterwards, along with mild cold symptoms.
65 2021-03-20 feeling abnormal Extreme vertigo when changing position in bed and upon rising - feeling of fogginess throughout the ... Read more
Extreme vertigo when changing position in bed and upon rising - feeling of fogginess throughout the day into the evening with vertigo reoccurring around bedtime (9pm). Feeling of " fogginess " and vision feels " off ". All of symptoms have continued each day since receiving vaccine. I have never had vertigo or dizziness during my lifetime.
65 2021-03-20 feeling abnormal Body aches (arms, shoulders, armpits, hands, neck, back, butt, calves, feet), headache, brain fog, f... Read more
Body aches (arms, shoulders, armpits, hands, neck, back, butt, calves, feet), headache, brain fog, fatigue, skin sensitivity. Lasted through the evening and the full next day. Fine on 3rd day.
65 2021-03-21 depression 1) redness on arm and darker line in middle of redness (not at injection site) 2) feelings of depres... Read more
1) redness on arm and darker line in middle of redness (not at injection site) 2) feelings of depression
65 2021-03-21 feeling abnormal Headache, muscle ache, fever, chills, nausea, fatigue, brain fuzz. Treated by bedrest. Took seve... Read more
Headache, muscle ache, fever, chills, nausea, fatigue, brain fuzz. Treated by bedrest. Took several days to go away.
65 2021-03-21 feeling abnormal Moderna COVID-19 Vaccine EUA Began ~11 hours after injection with dizziness at bedtime (11 pm). Woke... Read more
Moderna COVID-19 Vaccine EUA Began ~11 hours after injection with dizziness at bedtime (11 pm). Woke up around 3 am with a slight fever (100 degrees), achy muscles and joints, muscle weakness, dizziness and headache. Drank a glass of water, put gel ice pack on forehead, back of neck, injection site (very sore.) Went back to bed around 4 am, woke up again around 6, same symptoms, drank some more water and went back to bed again - very tired. Got up around 9 am, still feeling bad but fever was a little lower - 99.6. Fell asleep on the couch twice that day, took 1 ibuprofen around 3 pm. Reduced appetite that day. Fever gone by night time. Following day, ~48 hours post-injection, only symptom was continued dizziness. Some dizziness still on day 3, very slight on day 4.
65 2021-03-21 feeling abnormal Dizziness, Headache, Myalgia, Fever, Nausea Vomiting, FATIGUE,BRAIN FOG, REDUCED APPETITE, ALYERED S... Read more
Dizziness, Headache, Myalgia, Fever, Nausea Vomiting, FATIGUE,BRAIN FOG, REDUCED APPETITE, ALYERED SENSE OF SMELL Narrative:
65 2021-03-21 impaired work ability After receiving second does injection I went to bed at my normal time (10:00pm. I woke up during th... Read more
After receiving second does injection I went to bed at my normal time (10:00pm. I woke up during the night about 1:00 AM with soreness in arm, dizziness, low grade fever and chills. Felt lethargic all through the next two days. Saturday and Sunday my arm was still tender but I had no energy however I was experiencing headaches. Monday went back to work for 5 hours and returned home with low grade fever, chills, headaches and lethargic. Not coughing , I have an appetite and have not lost my since of smell.
65 2021-03-22 impaired work ability 3/19/21 body aches, flu like symptoms began at 2130; red sunburn like rash on lower chest 3/20/21 us... Read more
3/19/21 body aches, flu like symptoms began at 2130; red sunburn like rash on lower chest 3/20/21 used Benadryl 12.5 mg twice; 3/21 mid back itching and red rash, 3/22/21 fatigue and rash continues - called Moderna and physician there told her allergic reaction and to go either to ER or personal physician whichever faster, ER physician told her not allergic reaction but immune response. Advised Cortisone which has been helpful. Improved 3/23/21. Missed work 3/22 and 3/23, will return 3/24 if improvement continues.
65 2021-03-22 loss of personal independence in daily activities Woke with intermittent but very sore left knee pain. Might have been a little warm to touch but not ... Read more
Woke with intermittent but very sore left knee pain. Might have been a little warm to touch but not sure. No past h/o of knee pain or injury. To date, still experiencing intermittent left knee pain - not red, warm or swollen. Today (3/23) left shoulder is also very sore - couldn't open her vitamin jar and feels like she's been shoveling sand. No noted redness, swelling or warmth. Also noting intermittent bilateral hand and ankle pain. No other associated symptoms. Patient states she doesn't feel she needs to be seen by PCP at this time. Writer recommended Ibuprofen as directed every 6-8 hours as long as she has no contraindications to taking Ibuprofen (denies h/o kidney or GI issues). Recommend f/u with PCP for further evaluation if no improvement w/i 24-48 hours or if symptoms worsen. She is in agreement. Recommend discuss with PCP whether she should have 2nd vaccine.
65 2021-03-22 sleep disorder At 11:30 PM chills began. I could not stay warm. I wrapped up in warm blankets. I could not sleep... Read more
At 11:30 PM chills began. I could not stay warm. I wrapped up in warm blankets. I could not sleep. My skin felt tender to touch. Points of arthritis was extremely painful. Fever got up to 100 degrees. Fever broke around 7 am the next morning. I felt tired and weak that day. By 2nd morning began to feel better. Since that time I seem to be having inflammation issues.
65 2021-03-22 sleep disorder I had been doing really well with my irritable bowel and stomach issues for several weeks, but, the ... Read more
I had been doing really well with my irritable bowel and stomach issues for several weeks, but, the rash on my neck was in a flair up. I had some flairing going on with my upper neck and back area and some burning in my upper legs. I had gone to sleep on Wednesday night and around 3 A.M., I was awakened by a horrible burning sensation in my upper stomach, back, face, neck, and arms. They felt like they were on fire inside! My left lower jawbone was hurting up around the front of my ear into my cheekbone underneath my left eye. I took a terribly burning diaherra, chilling, and aching all over. I could hardly stand to set straight up in a chair , let alone lay down. This was terribly bad until around 8 or 9 A.M. It eased up some and I slept for a couple of hours. It came back intermittantly for the next four days and nights..So much worse at night. Even though I have issues with burning sensations and diaherra, etc., I have never experienced anything of this magnitude before! I am afraid whatever was in a flair up within me was magnified times over!
65 2021-03-23 feeling abnormal 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 excessive sleepiness Very weak, nauseated, achy for about 36 hours - spent the day after the shot in bed, sleeping. Took ... Read more
Very weak, nauseated, achy for about 36 hours - spent the day after the shot in bed, sleeping. Took two Alleve ibuprofens during that time, which helped a little. Fatigue diminished daily, but lasted about a week. A curious effect was tingling and slight pain at the site of two broken bones (tibia and fibula); breakage occurred over 40 years ago. Another curious note is that my orthopedic surgeon reported hearing the same thing from many other clients.
65 2021-03-24 memory impairment After the first dose on 1-29-2021 I was violently vomiting and nausea for several days. I was hesita... Read more
After the first dose on 1-29-2021 I was violently vomiting and nausea for several days. I was hesitant to get the 2nd vaccine but I did it anyway. My 2nd dose was on 2/25/2021. Exactly 2 weeks later on 3-11-2021 at 11am I went into a full seizure and my husband called 911. I was not aware of my surroundings until 3/12/2021 at 10am. I spent 4 days in Hospital . MD and several other Neurologists reviewed and tested me for seizures. I had no history and my tests came back with no reason or conclusion for having a seizure. The COVID vaccine had been the single only change in my life. I also had NO pre existing condition to have a seizure. I was so sick after the first vaccine 01/28/2021 that I did not think I should get the 2nd dose but I did. For over 30 years I have gotten my flu vaccine every year with no issues. I will never ever get a COVID vaccine again.
65 2021-03-25 insomnia Headache, eyes bright, , sore arm and neck, emptiness in stomach, sleepy did for a few hours, but ha... Read more
Headache, eyes bright, , sore arm and neck, emptiness in stomach, sleepy did for a few hours, but had a sleepless night, second day: headache, sore throat, emptiness in stomach, sore arm and neck. Took one Tylenol didn't help.
65 2021-03-26 loss of personal independence in daily activities, insomnia Extremely high fever, 103.5. Bone chattering shakes, vomiting, inability to sleep, overwhelming thir... Read more
Extremely high fever, 103.5. Bone chattering shakes, vomiting, inability to sleep, overwhelming thirst. Tylenol reduced the fever to a manageable 100. Symptoms persisted for 18 hours. Once the fever reduced, the ability to function slowly resumed. Normal function resumed after 60 hours.
65 2021-03-26 nervousness, excessive sleepiness I am only reporting so that there is a record of outcome for people with MS. My first shot on 2/25/... Read more
I am only reporting so that there is a record of outcome for people with MS. My first shot on 2/25/21 resulted in headache general feeling of not feeling well on 2/27. My 2nd dose on 3/25 resulted in my insides trembling for about a day, feeling cold but sweating, severe headache. I have only had this trembling inside feeling one other time and it was when I had food poisoning. It is like you cannot stop your insides from shaking. That was only 12 hours after vaccine and lasted all night. 3/26 was still feeling lousy, headache and trembling that came and went, and dizzy off balance feeling. Which is not unusual for me, but much more intense. I slept frequently. 3/27 - today I am still having slight headache but feel I am on the mend. Taking Tylenol for headache the whole time seemed to help. Just wanted to give input for people with MS.
65 2021-03-27 feeling abnormal, impaired work ability At 3:14a on Friday, 03/26, about fourteen hours after I received my second dose of Moderna, I awoke ... Read more
At 3:14a on Friday, 03/26, about fourteen hours after I received my second dose of Moderna, I awoke with terrible chills. [I felt fine before I went to bed. Worked until about 8:30p the day before.] My teeth were chattering so bad I thought they would break. I ached all over, was shaking from the chills, my head was pounding, and truly felt terrible. I have tried sleeping if away but that doesn't seem to be doing the trick. I did take some extra strength Excedrin which helped with the headache. It is now Sunday and I still ache somewhat and don't feel right. I have had a "sick stomach" - food just doesn't sit right - and still feel chilled. I had no problems with the first dose so was totally surprised by this. NO energy at all. I work two jobs and had to miss hours at both because of this. [Have worked, in person, the entire pandemic and have been super careful.] I feel less terrible now but several friends/family members urged me to report my symptoms since I normally am very healthy - for a 65 year old woman. I realize the vaccine got emergency usage approval so this information may be useful going forward. I know I'll be fine but mainly just wanted to report this - since it has lasted more than forty-eight hours.
65 2021-03-28 feeling abnormal Throwing up constantly, bad headache, lifeless until 8pm. Today 3/29 I don't have an appetite and my... Read more
Throwing up constantly, bad headache, lifeless until 8pm. Today 3/29 I don't have an appetite and my stomach feels nausea. I took a few bites for breakfast & a nice dinner but I feel weird.
65 2021-03-28 loss of personal independence in daily activities, depressed mood Muscle soreness and lethargic in general. I took two naps the day after shot and one nap the day af... Read more
Muscle soreness and lethargic in general. I took two naps the day after shot and one nap the day after that. Was unable to hike very far or work outside for more than 30 minutes before I needed to rest. Also felt depressed the third day after but not sure that is due to the shot.
65 2021-03-28 sleep disorder Loss of appetite, Chills and sweats, fever, body aches and pains, dizziness, unable to sleep due to ... Read more
Loss of appetite, Chills and sweats, fever, body aches and pains, dizziness, unable to sleep due to these side effects. Have not slept in 3 nights due to these symptoms. I've been in bed since Friday night.
65 2021-03-28 sleep disorder Extreme fatigue/sleepiness 5 days Fever day 2 101.5, day 3 99 Aches 3 days Chills sweats 4 days Pain... Read more
Extreme fatigue/sleepiness 5 days Fever day 2 101.5, day 3 99 Aches 3 days Chills sweats 4 days Pain at site
65 2021-03-29 anxiety 1415- Patient in observation, recovering from 2nd vaccination. Complained of feeling dizzy. Very an... Read more
1415- Patient in observation, recovering from 2nd vaccination. Complained of feeling dizzy. Very anxious prior to receiving vaccination, needed the support of several nurses to keep her calm, per NP. NP evaluating patient. EMS here. EKG leads attached. BP initial 170/118; HR 49-52. Sat on RA 98%. Monitor shows sinus bradycardia, ? > pr interval, inverted T waves. O2 3 L np applied at 1428. No change in HR . BP 168/98. EMS wishes to transport patient to hospital. Patient has refused. Patient signed AMA form, and completed Observation time without incident. Police Department Sargeant to speak w patient, advising her she should notify a family member and not drive, etc. Patient appeared lucid to Officer. He had no reason to detain her. Patient exited clinic using her walker @ 1450.
65 2021-03-29 disorientation She got the vaccine, had no reaction at the injection site. She went home and took it easy and went... Read more
She got the vaccine, had no reaction at the injection site. She went home and took it easy and went to bed. She woke up the next morning around 7:00 AM and while brushing her teeth started vomiting, blood in color. She then started diarrhea, and the stool was the same color, and felt like somebody had hit her. Her bed is 15' from her bed, and could not get back and forth and was stumbling and exhausted from that small distance. She could not hold her head up, and had to stay in the bathroom to get enough energy to get back to the bed, and could not get her feet up to get back in the bed due to being winded and exhausted as well. This went on for a couple of days. She did not eat, but nothing was staying down. She had chills, was wrapped up in quilts, cold, and her hips, knees and ankles felt like somebody was pulling her apart. On Sunday she started to begin feeling better, was light sensitive, almost a migraine type headache, sensitive to sound, and lost track of time. She is still having some of the symptoms, the worst has passed, but still feels disoriented, dizziness. Her right arm has a buzzy feeling on the upper and lower arm, both hands are very swollen, the right more so than the left. Her fingertips were going numb on her right arm, but not on the left where she got the vaccine. She would have to rub them to get the feeling to come back. She is very shaky very easily, and if she turns too fast she will get dizzy. For the stomach she normally takes Pantoprazole and her roommate got her some generic Omeprazole which calmed her stomach down and has been finishing up that bottle, but it was still not feeling well. She never ran any fever, but never runs a fever, and took her temp a few days ago was 97.8 which is normal for her. She has called her doctor and then called her again yesterday and missed her return call and will speak with her today.
65 2021-03-29 feeling abnormal Overwhelming severe pain systemically in joints and muscles on the night of 3/20 that continues to a... Read more
Overwhelming severe pain systemically in joints and muscles on the night of 3/20 that continues to a lesser degree and off and on since the initial several hours. If it had gone on for much longer I would have had to go the the hospital. The level of pain was terrifying....and lest you think it's just that I can't handle pain, I've given birth to 5 children without any pain mediation whatsoever. I am still in the depths of an autoimmune flair-up where severe pain in my joints and muscles occur. I continue to feel significant fatigue. I also continue to experience some level of "brain fog" (the inability to follow though streams for long, read more than a few sentences at a time, inability to stay mentally organized). Mild nausea and inability to digest well continues since the day of the vaccine 3/15.
65 2021-03-30 sleep disorder The first thing that happened was immediate feeling of neck ache. I could actually feel the vaccine ... Read more
The first thing that happened was immediate feeling of neck ache. I could actually feel the vaccine travel up to my neck. The neck stiffness and ache still remains. On day 2, I had body aches, chills, flu like nausea and a low grade fever. The body aches and chills resolved within a day, however the fever and flu like symptoms did not. In addition, I have had lethargy and tiredness (but with problems sleeping ). These symptoms have persisted since March 12th. Dr. ran lab tests that all came back normal. There has been no specific treatment.
65 2021-03-31 confusional state First 24 hours s/s of fatigue, not thinking clearly, I did not feel well Day 2 s/s nausea and +the s... Read more
First 24 hours s/s of fatigue, not thinking clearly, I did not feel well Day 2 s/s nausea and +the symptoms seemed to move down into the muscles of my chest and trunk, and I still don't feel well Day 3 and 4 s/s/ lower back pain for 2 days, and I still don't feel well
65 2021-03-31 disorientation Lethargic,Disoriented
65 2021-03-31 feeling abnormal, sleep disorder, restlessness 10:45 that night, Tuesday the 30th, had teeth chattering chills for a couple of hours. Couldn?t sle... Read more
10:45 that night, Tuesday the 30th, had teeth chattering chills for a couple of hours. Couldn?t sleep, restless, Next morning, Wednesday the 31st, lethargic, felt like I?d been hit by a truck.. body ached, shoulder arm area, lower back were the hardest hit. Felt better Thursday morning, April 1st, still a bit foggy headed, but was able to be active.
65 2021-03-31 feeling abnormal 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 feeling abnormal numbness of upper left side including left eye. Difficulty walking, moving, getting out of bed due t... Read more
numbness of upper left side including left eye. Difficulty walking, moving, getting out of bed due to scarce muscle strength. swelling of the site (COVID ARM) 4" in diameter, hard, rash, itchy, sore + pain if touched. No overall swelling warmth at the injection site Fatigue - Slept for the majority of 36 hours. Woke only to eat a little & attend to pets Headache - began shortly after the vac but grew & continued despite taking meds. mental fog Back and forth mild fever switching to chills
65 2021-03-31 insomnia Chills 100.4 fever. head ache. Sleepness
65 2021-03-31 nervousness Arm ached first at about 1:00 then at 3:00 started feeling ?yucky? and chills . Lasted all night an... Read more
Arm ached first at about 1:00 then at 3:00 started feeling ?yucky? and chills . Lasted all night and next still sick and shaky.
65 2021-04-01 feeling abnormal Headache, muscle and lymph node pain, nausea, dizziness. fog, chills, loss of bladder control, sense... Read more
Headache, muscle and lymph node pain, nausea, dizziness. fog, chills, loss of bladder control, sense of semiconsciousness, from 7am Tue until 7am Wed
65 2021-04-01 memory impairment Stroke like symptoms: 1 day after vaccine developed left hip pain with frequent falls. Days later de... Read more
Stroke like symptoms: 1 day after vaccine developed left hip pain with frequent falls. Days later developed slurred speech, memory impairment and facial droop.
65 2021-04-02 amnesia, disturbance in attention Within 10 minutes, nausea. Faded, Returned once home, treated with ginger ale. Through course of e... Read more
Within 10 minutes, nausea. Faded, Returned once home, treated with ginger ale. Through course of event drank water and gingerale. 17 hours after injection (2:00 a.m.), awoke with very sore arm, aches, and fever of 98.6 (normal temp in 97.5 range). 20 through 28 hours after injection, aches increased, dry cough, very significant headache (right side into right eye and front center), deep heavy pain in between shoulder blades, upper back both sides (kidney area) and left side under lower ribs, deep dull pain in diaphragm, up into chest. Temp increased to 101.8. Ice cold hands. 30 hours after injection, cognitive issues: started a load of bedding in wash, then later found the laundry washed and dried and on the bed. Had no memory of doing it. Husband reports I kept repeating myself. Remember having problems focusing. 35 hours after injection, temperature drop to 99.9. Diarrhea. Ate small dinner but don't remember doing so. 42 hours after injection, temperature at 97.6. Body aches gone. Toes hurt. Pain left side under lower ribs. NO vomiting or chills during event.
65 2021-04-03 feeling abnormal 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 2021-04-03 insomnia Dizziness after injection, High fever (104), chills for approximate one and a half days, severe inje... Read more
Dizziness after injection, High fever (104), chills for approximate one and a half days, severe injection site pain followed by swelling, heat , swollen lymph node under arm, pain for a few days, insomnia, appetite loss. 2 days after injection asthma exacerbation with viral type symptoms, same as I experienced 2 days after last injection. It lasted about a week after the first injection.
65 2021-04-03 loss of personal independence in daily activities Within 12 hours, severe muscle pain and limited range of motion in neck and upper back; lasted the f... Read more
Within 12 hours, severe muscle pain and limited range of motion in neck and upper back; lasted the first time 24 hours, 2nd dose, it lasted just about 14 hours before subsiding; the 2nd dose landed me in bed all the next day with severe pain, feeling lethargic, at least one time, extremely diaphoretic and needed assistance back to bed. The muscle/soft tissue pain was the most severe pain in may entire life.
65 2021-04-04 feeling abnormal BODILY ACHES, FUZZY HEAD (more than usual) FLU LIKE SYMPTOMS (no upset stomach) . I TOOK TYLENOL ... Read more
BODILY ACHES, FUZZY HEAD (more than usual) FLU LIKE SYMPTOMS (no upset stomach) . I TOOK TYLENOL , DRANK FLUIDS AND SLEPT
65 2021-04-04 sleep disorder My left arm became very painful. On April 1 I could not move my arm . My arm was dead weight and was... Read more
My left arm became very painful. On April 1 I could not move my arm . My arm was dead weight and was extremely painful. I lost complete use of my arm and hand. I could not sleep it was so painful. It felt like my arm was broken. My husband and I both had side effects. I have regained most of the use of my arm, but it is still not 100%.
65 2021-04-05 anxiety Patient stated she feels lightheaded/SOB, nurse obtain blood pressure 127/72 with mild anxiety noted... Read more
Patient stated she feels lightheaded/SOB, nurse obtain blood pressure 127/72 with mild anxiety noted. Patient stated she needed her inhaler. Writer attempted to call 911 and patient denied SOB, no respiratory distress noted. Writer and nurse assisted patient to her home to use inhaler. Patient used inhaler and stated relief. Writer and nurse observed patient home was extremely hot, education was implemented, patient verbalized understanding. Life alert necklace was implemented and put on patient. Patient was educated when to call 911.
65 2021-04-05 confusional state 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 feeling abnormal 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 insomnia Extreme pain in left shoulder and arm and very limited range of motion within 2 hours. I could not ... Read more
Extreme pain in left shoulder and arm and very limited range of motion within 2 hours. I could not lift my arm which made it difficult to bathe and dress. Pain also caused difficulty sleeping. I iced it and kept it stable in a sling for a week and then gradually started moving it. My primary care prescribed Ibuprofen 800mg and Diclofenac gel. The pain and range of motion has improved over the last 12 days. I still have some pain with certain motions and have dIfficulty sleeping on my left side.
65 2021-04-05 insomnia I had muscle aches, diarrhea, extreme tiredness (not sleeping well) for 3 days after the shot. Then... Read more
I had muscle aches, diarrhea, extreme tiredness (not sleeping well) for 3 days after the shot. Then I was just tired all the time (continued not sleeping well) and experiencing diarrhea this lasted for 2 and half weeks. At this time I am still experiencing tiredness and not sleeping well. However the diarrhea seems to have resolved.
65 2021-04-05 thinking abnormal, disorientation, confusional state, feeling abnormal 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 2021-04-06 excessive sleepiness Chills, headache, exhaustion. Already asleep for 14 hours.
65 2021-04-06 excessive sleepiness 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 sleep disorder 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 feeling abnormal Foggy brain and I can't function very well , very slight headache off and on, and my depth percepti... Read more
Foggy brain and I can't function very well , very slight headache off and on, and my depth perception is affected.
65 2021-04-07 excessive sleepiness At 9pm, same day of vaccine, had moderate right arm soreness and chills. Took 1 200mg Motrin, applie... Read more
At 9pm, same day of vaccine, had moderate right arm soreness and chills. Took 1 200mg Motrin, applied ice pack to right arm. Slept for 12 hrs. Next morning, took 3 attempts to get out of bed. Felt light headed and very fatigued. Slept for most of the day and night. Felt much better by 3/29-the next day. Starting on 3/30 at 2:30am, I had itchy hives upper and lower flank area, both sides, under breasts, r thigh, neck and ears. Took 2 25 mg benadryl and they went away. Hives back in same areas at 2:30am on 4/1, and 4/3. Treated w 2 benadryl and went away. Same hives back at 7:30am 4/5, 8:30pm on 4/6 and 4:30am 4/8. Treated w 1-2 benadryl on those dates and went away. No food, med or laundry changes noted.
65 2021-04-08 confusional state, impaired work ability 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 2021-04-08 feeling abnormal Started with headache, froze all night with shakes, hurt all over, weak, next morning fever felt hor... Read more
Started with headache, froze all night with shakes, hurt all over, weak, next morning fever felt horrible, next night had night sweats, today extremely weak and fatigue. Brain fog. Shakes.
65 2021-04-09 excessive sleepiness, nightmare, feeling abnormal, hallucination the rash is mostly on her right forearm; her eyes and the line of the eyelash are black and little p... Read more
the rash is mostly on her right forearm; her eyes and the line of the eyelash are black and little pink; really bothering me : body aches, and the allergy reactions; really bothering me : body aches, and the allergy reactions; shaking; felt flu like symptoms; slept 36 hours straight; had a lot of nightmares; it was really strange , like i was not fully awake, like an alternate state; She knew she had to wake up and do some things like call a person but she could not actually; 3 hours after the shot, patient started to feel, extreme fatigue; Needed to stop walking because she had difficulty breathing; body pain; swollen face since she got the vaccine; face swollen and also the glands under her chin , her hands are swollen up; her throat is swollen and has a whizzing when breathing; Rash on her body; problems regulating her body temperature, she was extremely hot or extremely cold; lost her ability to walk, with no balance; had difficult to get her legs into her car, could not lift the legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HALLUCINATION (She knew she had to wake up and do some things like call a person but she could not actually) in a 65-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 Allergic reaction (allergic reaction around 10 years ago with a flu shot). Concomitant products included VITAMIN D3, ZINC and MONTELUKAST for an unknown indication. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 22-Feb-2021, the patient experienced FATIGUE (3 hours after the shot, patient started to feel, extreme fatigue), DYSPNOEA (Needed to stop walking because she had difficulty breathing), MYALGIA (body pain), FACE OEDEMA (swollen face since she got the vaccine), SWELLING (face swollen and also the glands under her chin , her hands are swollen up), LYMPHADENOPATHY (her throat is swollen and has a whizzing when breathing), RASH (Rash on her body), BODY TEMPERATURE FLUCTUATION (problems regulating her body temperature, she was extremely hot or extremely cold), BALANCE DISORDER (lost her ability to walk, with no balance) and GAIT DISTURBANCE (had difficult to get her legs into her car, could not lift the legs). On 26-Feb-2021, the patient experienced HALLUCINATION (She knew she had to wake up and do some things like call a person but she could not actually) (seriousness criterion medically significant), TREMOR (shaking), INFLUENZA LIKE ILLNESS (felt flu like symptoms), HYPERSOMNIA (slept 36 hours straight), NIGHTMARE (had a lot of nightmares) and FEELING ABNORMAL (it was really strange , like i was not fully awake, like an alternate state). On 12-Mar-2021, the patient experienced RASH (the rash is mostly on her right forearm), EYE COLOUR CHANGE (her eyes and the line of the eyelash are black and little pink), PAIN (really bothering me : body aches, and the allergy reactions) and TYPE IV HYPERSENSITIVITY REACTION (really bothering me : body aches, and the allergy reactions). On 24-Feb-2021, BODY TEMPERATURE FLUCTUATION (problems regulating her body temperature, she was extremely hot or extremely cold) had resolved. At the time of the report, HALLUCINATION (She knew she had to wake up and do some things like call a person but she could not actually), FATIGUE (3 hours after the shot, patient started to feel, extreme fatigue), DYSPNOEA (Needed to stop walking because she had difficulty breathing), MYALGIA (body pain), FACE OEDEMA (swollen face since she got the vaccine), SWELLING (face swollen and also the glands under her chin , her hands are swollen up), LYMPHADENOPATHY (her throat is swollen and has a whizzing when breathing), RASH (Rash on her body), RASH (the rash is mostly on her right forearm), EYE COLOUR CHANGE (her eyes and the line of the eyelash are black and little pink), TREMOR (shaking), INFLUENZA LIKE ILLNESS (felt flu like symptoms), HYPERSOMNIA (slept 36 hours straight), NIGHTMARE (had a lot of nightmares), FEELING ABNORMAL (it was really strange , like i was not fully awake, like an alternate state), PAIN (really bothering me : body aches, and the allergy reactions), TYPE IV HYPERSENSITIVITY REACTION (really bothering me : body aches, and the allergy reactions), BALANCE DISORDER (lost her ability to walk, with no balance) and GAIT DISTURBANCE (had difficult to get her legs into her car, could not lift the legs) 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 also included supplements (not specified). Montelukast, ibuprofen 800mg daily since the 1st dose was administered. Based on the current 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 loss of personal independence in daily activities Fever, severe fatigue, nausea, facial swelling around right eye and visual impairment in right eye, ... Read more
Fever, severe fatigue, nausea, facial swelling around right eye and visual impairment in right eye, (flashing white light) Severe fatigue and aching-had to have friends take dog out, unable to walk any distance. I am very healthy with no health issues, so for me this was very unusual. I did not seek any medical assistance, I was too sick to even consider.
65 2021-04-09 sleep disorder Severe pain in right arm started about 2.5 hours after injection and lasted approx. 28 hours. I co... Read more
Severe pain in right arm started about 2.5 hours after injection and lasted approx. 28 hours. I could not sleep. (After shot#1, I had some minor shoulder soreness for 24 hours) Low fever (99.5) began approx. 18 hours after injection and lasted approx. 12 hours. Extremely tired day after shot.
65 2021-04-10 disturbance in attention, confusional state, disorientation, nightmare, insomnia, impaired work ability The following day felt a little off mentally. Had a slightly elevated temperature (for me) 98.9 At ... Read more
The following day felt a little off mentally. Had a slightly elevated temperature (for me) 98.9 At around 4:30 began to feel very confused and unable to work. Went home and experienced great disorientation, had difficulty with balance - had to hold onto furniture and walls to walk. It was almost like hallucinations. I was in and out of sleep and had nightmares. I was not in any condition to make a logical decision to take my temperature, or do anything else for that matter, or call for help. Did not eat or drink much water. On 4/9 I woke around 9 am, still felt moderate disorientation. Elevated temperature - 99.3. Not until 4 pm did I start to feel almost normal. Not much appetite, 4/10 Still slight disorientation all day. No fever. 4/11 slept most of the day on and off. Right now I feel okay, but not back to normal. never contacted health care provider nor went to ER. (I did not mention in the medications section that I take insulin: Lantus 1x day, Novolog 3x day, Trulicity 1x week.)
65 2021-04-10 impaired work ability, nervousness Cough. Headache. Body aches. Fatigue. Nausea. Congestion.
65 2021-04-10 sleep disorder Within 30 mins I started to experience high arm pain (not you normal sore arm) By evening the pain w... Read more
Within 30 mins I started to experience high arm pain (not you normal sore arm) By evening the pain was becoming unbearable. I was unable to move it, without great pain. by bed time it was EXCRUCIATING. I was unable to sleep and was curled in a ball in great pain. The pain went from shoulder to fingers and was a throbbing, intense pain. I have never feel so much pain from anything before. I also had a swollen arm, mild rash and a bit itchy. By morning pain went from level 10 to 9 and continued all day from level 6-10. This continues that week again from level 5-8, so was a bit better. After approximately 10 days I was able to use the arm, it's now a month and still unable to sleep on it and still feels sore. The pain comes only if I put stress on it and the pain is manageable. I took no OTC or prescription medications for this pain.
65 2021-04-11 loss of personal independence in daily activities, impaired work ability Severe migrating joint and muscle pain lasting approximately 10 days non stop Required cessation of ... Read more
Severe migrating joint and muscle pain lasting approximately 10 days non stop Required cessation of daily activities including work Symptoms began to abate approximately March 11
65 2021-04-11 loss of personal independence in daily activities I woke up the next morning with a head splitting that went down to my next. I had a fever, dry heave... Read more
I woke up the next morning with a head splitting that went down to my next. I had a fever, dry heaves, diarrhea, and bed body aches. This was followed with over all weakness. There was also a strange taste in my mouth. This went on till the next day. My fever broke around 11 a.m. on Saturday. I could not drive to get to an Urgent Care. I have yet to contact my Doctor but I did call the nurse line. They gave me this website. I still have body aches but not like the previous days, and light headedness. But I couldn't eat for two days.
65 2021-04-11 loss of personal independence in daily activities She experienced weakness & aches shortly after midnight (10-12 hours after 2nd dose). She fell in t... Read more
She experienced weakness & aches shortly after midnight (10-12 hours after 2nd dose). She fell in the middle of the night and was too weak to get herself up. The weakness subsided, but tremors (she has had essential tremors her whole life) are significant & began the day after the shot. She can "feel them from the inside," they are much more significant than she has ever experienced, and sometimes violent, involuntary convulsions. She finds difficulty performing day-to-day functions such as eating or drinking. She first reported about 5 days after the shot (not to this severity, and she complained more about the weakness) , now reports they still persist. She is of good spirit. Her doctor is doing telemedicine & knows of the events. He was to get with her this afternoon after we talked.
65 2021-04-12 feeling abnormal Patient came to the clinic on 4/9/2021 at 4:30PM and stated that she has been feeling like someone i... Read more
Patient came to the clinic on 4/9/2021 at 4:30PM and stated that she has been feeling like someone is pinching her all over since she received the first dose of Moderna on 4/1/2021. She stated that it was not a severe pinching feeling, but irritating because it was consistent. She had no pruritis, erythema or edema at the injection site. I told her to take Benedryl as indicated on the bottle and if she did not have relief by Monday, 4/12/2021, to go to an urgent clinic or her physician. She needs a translator and I used a bilingual vaccinator at the clinic to translate.
65 2021-04-12 feeling abnormal IN THE 15 MINUTE WINDOW AFTER VACCINATION PATIENT DEVELOPED SWELLING AND REDNESS ON HER RIGHT LEG, T... Read more
IN THE 15 MINUTE WINDOW AFTER VACCINATION PATIENT DEVELOPED SWELLING AND REDNESS ON HER RIGHT LEG, THAT WAS WARM TO THE TOUCH. PATIENT HAD AN INCREASED BREATHING RATE, AND REPORTED FEELING STRANGE. PATIENT WENT TO ER, ER CONFIRMERD SWELLING IN LEG WAS NOT DUE TO A CLOT. PATIENT TOOK BENADRYL.
65 2021-04-13 disorientation Fever, severe headache (felt like neck could not support my head- had to prop up on pillows for supp... Read more
Fever, severe headache (felt like neck could not support my head- had to prop up on pillows for support) dizziness, severe fatigue, slightly disoriented, joint aches, nausea - symptoms persisted for 24 hours - treated with Advil 48 hours later dizziness still persists and fatigue but much improved.
65 2021-04-14 agitation, nightmare, confusional state, anger, insomnia, fear, irritability, crying, feeling abnormal, delirium 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 2021-04-14 confusional state, abnormal dreams Pt stated she completed the Moderna vaccine series on 3/13/21 and 4/13/21. She has been in bed for ... Read more
Pt stated she completed the Moderna vaccine series on 3/13/21 and 4/13/21. She has been in bed for the last 3 days. The first day she was unable to move from the bed and had a fever of 102, headaches, incontinence. She is able to move some today but states her legs are rubbery which is a feeling she has never felt before. She said she has been very confused the last few days and dreaming a lot more than usual. She is improving but still not back to herself at this time and plans to discuss with her neurologist later today.
65 2021-04-14 confusional state 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 impaired work ability The day after receiving 2nd Covid19 vaccine (sometime in the afternoon), I began having pain in my r... Read more
The day after receiving 2nd Covid19 vaccine (sometime in the afternoon), I began having pain in my right underarm, fatigue and fever. was not able to go to work the following day with fever & pain in right underarm continuing. Was able to go to work the next day, however the underarm pain was pretty significant over the next several days and I did notice some swelling in the area. I went online and saw that this is a side affect that is not that unusual, and would have called my primary care physician if it had persisted. The pain and swelling subsided in just under a week.
65 2021-04-15 feeling abnormal Immediately I could taste a metallic salty taste in my throat. About 1 minute later my throat was bu... Read more
Immediately I could taste a metallic salty taste in my throat. About 1 minute later my throat was burning and itching and I began coughing. The nurses put me in a room with another nurse, gave me cold water and watched me. 5 minutes later I began feeling dizzy and nauseated. My throat seemed to settle a bit and I finally told them I felt good enough to leave about 45 minutes later. Around 5 pm my throat was still burning and throbbing, so I took a benedryl, claritin and a pecid. My head felt fuzzy. I ate ice cream for dinner because my throat kept throbbing and I was still nauseated. I went to bed at 6 PM and around 10 PM I woke up with my throat throbbing and burning and I ached all over as if I'd been beaten in my sleep. I considered using my epi pen, but took another claritin and Hydrocondone instead because I never had trouble breathing and my lips didn't swell. The worst was the swollen, itchy, throbbing throat and body aches. By morning my throat had cleared up, but the body aches and headaches, and fuzzy headed are still with me 10 days later. I feel permanently damaged by the vaccine.
65 2021-04-15 feeling abnormal 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 excessive sleepiness Fever chills, sweeting, slept for over 24 hours, swelling at the injection spot, achy diarrhea it ha... Read more
Fever chills, sweeting, slept for over 24 hours, swelling at the injection spot, achy diarrhea it has been over 2 weeks now I I have a itchy rash on my arm the site of the injection just appeared
65 2021-04-15 insomnia Onset of chills/fever about 10 hours after injection. Duration of chills/fever, about 10 hours. (No ... Read more
Onset of chills/fever about 10 hours after injection. Duration of chills/fever, about 10 hours. (No access to thermometer during this time but, based on past experiences, not a high fever.) Redness/tenderness centered about 6 inches below injection site, and towards the front/inside of arm: onset about 1 day after injection, growing for about 2-3 days, now subsiding after 5 days. Minor arm ache, but not limiting movement. Achy joints when in fever/chills stages. Also some insomnia. Diffuse headache and low-level nausea, about 5 days. Mostly gone now, after 5 full days.
65 2021-04-15 poor quality sleep Restless sleep first night, slight arm soreness. Beginning the next morning, skin hypersensitivity, ... Read more
Restless sleep first night, slight arm soreness. Beginning the next morning, skin hypersensitivity, particularly arms and legs. Took two tablets 500mg Advil, this relieved the issue. Most notable reaction has been tinnitus, noticed some time that morning. Consistent background 'buzz' which has not abated. Annoying.
65 2021-04-16 confusional state, feeling abnormal Walk from sight of shot to where my husband sat and started to fall dizzy. Then my head started to ... Read more
Walk from sight of shot to where my husband sat and started to fall dizzy. Then my head started to swarm, by this I mean(nose is the middle) Left side of my brain was turning clockwise and the right side of my brain was turning counterclockwise. Then the right side of my tongue started to tingle. They came and gave me Benadryl. After 1 hour from the time they gave me the shot I thought I could walk to my car without falling. Next day, just felt like something foreign was in my body--didn't feel right. 4/17/2021-I still get confuse on what day it is, and my hands itch off and on. Continuation page won't let me type there. Need to add Medications--#9
65 2021-04-17 sensation of foreign body 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 loss of personal independence in daily activities My left arm became very swollen, red and itchy and remained that way for 3 weeks. In addition, I wa... Read more
My left arm became very swollen, red and itchy and remained that way for 3 weeks. In addition, I was very congested, coughing, extremely lethargic and had no appetite. I struggled to complete the simplest task, and then had to rest for a lengthy period of time before attempting another errand. To date, I continue to be very tired, more than is normal for me, which is far worse as the day progresses. Some days are much worse to the extent I'm largely unable to do any tasks or chores around our home; others are pretty good in the morning with the tiredness growing much worse as the day goes on.
65 2021-04-19 panic attack, insomnia When I got the first shot om February 27th, I felt ok. But, in the third week my calves began to fe... Read more
When I got the first shot om February 27th, I felt ok. But, in the third week my calves began to feel a little off. When I got the 2nd shot on March 27th, I seemed to have more energy for two days. Almost three days after Shot #2, my legs and feet started tingling and twitching. I had no appetite, couldn't sleep, and had a panic attack. My symptoms are persisting three weeks later. I spoke to Dr. by phone on April 7th. He said it was probably an extreme inflammatory response.
65 2021-04-20 confusional state 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 feeling abnormal 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 delirium Next morning severe headache to the point of delirium....2nd day a little better...headache gone....... Read more
Next morning severe headache to the point of delirium....2nd day a little better...headache gone....fatigue...3rd day still tired..got up in late afternoon....tiredness lasted about 5days
65 2021-04-21 sleep disorder 30 minutes after vaccination (#2) ears suddenly felt plugged. Over the next 2-3 days, plugged feelin... Read more
30 minutes after vaccination (#2) ears suddenly felt plugged. Over the next 2-3 days, plugged feeling in ears would temporarily improve then return. Never seemed to lose hearing.Mild inner ear issues with some dizziness during that first week following the vaccine. On Weds., March 24th tinnitus in left ear began and intensified throughout the day so that I was unable to sleep that night. Continued significantly into next day and night. (March 25th.) Since that time it has lessened somewhat at times, but also intensified at times to the point of being very disruptive to focus and sometimes to sleep. Seems to be pretty much constant in the left ear at this time. Hoping it will subside over time. May not risk booster
65 2021-04-21 sleep disorder Chest pain, fast heart beat - painful lasted for 3 day. Couldn't fall asleep
65 2021-04-22 mental status changes Admitted with aeseptic meningoencephalitis without any other known cause. Had some low grade fever ... Read more
Admitted with aeseptic meningoencephalitis without any other known cause. Had some low grade fever for 24 hours s/p 2nd vax. Found by husband aphasic/lethargic/unwell 6 days later, brought to ER. LP was mildly abnormal; had MRI which showed an incidental anterior cerebral artery aneurysm but nothing else of note. No high fevers. She did receive <24 hours of IV acyclovir but really improved rapidly, however still has significant altered mental status; HSV PCR neg, enterovirus PCR neg, cultures neg; Lyme serology neg. She does in home child care and a couple of children had HFMD/coxsackie virus.
65 2021-04-23 memory impairment, feeling abnormal, confusional state Second dose: Stinging as injected. Soreness across shoulders and neck. Over the next hour soreness ... Read more
Second dose: Stinging as injected. Soreness across shoulders and neck. Over the next hour soreness turned to stiffness. In 8 hours was having chills and a very bad headache. Sleepy, body aches and shortness of breath when walking. Very tired. Next day still felt bad. The same symptoms. Over counter medications did not help the headache. I never had a fever. The last month i have brain fog, confusion, forgetfulness and mistakes I never made before the vaccine. Its an effort to get through work.
65 2021-04-24 depression, feeling abnormal 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 feeling abnormal Patient Presented at Pharmacy, stated did not feel good and was very dizzy, patient was very unstea... Read more
Patient Presented at Pharmacy, stated did not feel good and was very dizzy, patient was very unsteady and almost fell down.
65 2021-04-24 sleep disorder Jabbing pain around the Appendix area and the lower back on the right hand side. Lasted about 4 ho... Read more
Jabbing pain around the Appendix area and the lower back on the right hand side. Lasted about 4 hours. Could not could not sleep on right side of Body as pain got Worse. Did have nausea all day ,vomited once and had low grade fever. Horrible Muscle Ache and felt like every bone in my body ache. I new about other symptoms but the jabbing pain was not expected.
65 2021-04-25 excessive sleepiness, crying violent, screaming, throwing things, crying, slept 3 days, diarrhea, chills, lost vision, shaking,
65 2021-04-25 loss of personal independence in daily activities 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 feeling abnormal 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 2021-04-27 impaired work ability I received the first dosage of Moderna on Feb 3rd by injection on my right arm. On Feb 8th I starte... Read more
I received the first dosage of Moderna on Feb 3rd by injection on my right arm. On Feb 8th I started experiencing rash/hives around my neck, chest, arms, stomach, along with swelling around my neck. The swelling on my neck was oozing. The itching was unbearable. However I was advised to get the second shot on March 3 rd. However after the second vaccine my condition got worse. I went to the ER and i was admitted into the hospital and spend a day in the hospital. The treatment give did not help. I was prescribed Benadryl and it did not help. I continued to itch all over my body and it's unbearable. I went to my primary care doctor for relief and i was sent to the emergency room once again. I was prescribed Benadryl for the itching. I have been taking Benadryl for over a month. The swellings on my neck they are scared to operate. My life has been turned upside down after getting this Moderna vaccine. It cause me to take time off from my job. I am itching over and over. I am in pain. My body is full of rash, the welling on my neck hurt. I am uncomfortable.
65 2021-04-28 feeling abnormal 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 sleep disorder 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 2021-04-30 feeling abnormal Day of second shot 03/19, was ill, with 99.9 fever,chills, no appetite. Mind was foggy.
65 2021-04-30 suicidal thoughts contemplated suicide; She lost 55 decibel in left ear/ was diagnosed with sensorineural hearing loss... Read more
contemplated suicide; She lost 55 decibel in left ear/ was diagnosed with sensorineural hearing loss; left ear felt like I am in the plane and need to pop my ear; She had tinnitus/ringing in her ear; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS NEUROSENSORY (She lost 55 decibel in left ear/ was diagnosed with sensorineural hearing loss) and SUICIDAL IDEATION (contemplated suicide) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported by the reporter. The patient's past medical history included No adverse event (No Historical Condition reported). Concomitant products included CALCIUM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Bone disorder NOS. 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) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced EAR DISCOMFORT (left ear felt like I am in the plane and need to pop my ear), TINNITUS (She had tinnitus/ringing in her ear) and HEADACHE (Headache). On 15-Apr-2021, the patient experienced DEAFNESS NEUROSENSORY (She lost 55 decibel in left ear/ was diagnosed with sensorineural hearing loss) (seriousness criterion medically significant). On an unknown date, the patient experienced SUICIDAL IDEATION (contemplated suicide) (seriousness criterion medically significant). At the time of the report, DEAFNESS NEUROSENSORY (She lost 55 decibel in left ear/ was diagnosed with sensorineural hearing loss) was resolving, SUICIDAL IDEATION (contemplated suicide), EAR DISCOMFORT (left ear felt like I am in the plane and need to pop my ear) and HEADACHE (Headache) outcome was unknown and TINNITUS (She had tinnitus/ringing in her ear) had not resolved. Not Provided Treatment medications included prednisone 60 mg for 10 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.
65 2021-05-01 thinking abnormal, anger, agitation I can no longer thunk straight, things r being confiscated in my head. Extreme anger, axgiated madne... Read more
I can no longer thunk straight, things r being confiscated in my head. Extreme anger, axgiated madness. Intense migaines and muscular weakness. Bell's palzy.
65 2021-05-02 sleep disorder 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 2021-05-04 feeling abnormal, disorientation Within minutes: brain fog, disorientation, needed walked out to car so could be driven home. Lasted ... Read more
Within minutes: brain fog, disorientation, needed walked out to car so could be driven home. Lasted 3 days. Day 9 post vaccine: Covid arm (red swollen area about 2x4 inches); Covid throat on left side – swelled to size of tennis ball. Treated with allergy meds, ice; no impact on breathing / swallowing. Throat swelling gone by a.m., arm swelling lasted 7 days. LOTS of nerve pain: hit every place my body has been injured / had surgery. Worst with wrists, hands, mouth, and left hip (replaced in 2010). Also impacted arthritis in hands and feet causing painful flare ups. Other than arthritis have no more nerve pain or brain fog since 4/30/21. Also experienced emotional lability and sense of overwhelm: lasted 3 weeks.
65 2021-05-04 feeling abnormal, sleep disorder Woke up at 230 am ten hours after receiving 2nd dose with fever, chills feeling awful, unable to w... Read more
Woke up at 230 am ten hours after receiving 2nd dose with fever, chills feeling awful, unable to warm up. That lasted approximately fours hours. Three days later tinnitus began all day and night lasting two and a half weeks sounding like some kind of Morris code. It slowly began to fade. I have never had tinnitus!
65 2021-05-07 feeling abnormal 12 hours after vaccine I got dizzy, extremely off-balance and needed help walking in my house. I fe... Read more
12 hours after vaccine I got dizzy, extremely off-balance and needed help walking in my house. I felt like I was being tossed about in a storm. When I slept, I woke soking wet and believe I had a fever but didn't take temp. It all lasted about 14 hours. A few hours after the 14, I felt completely normal.
65 2021-05-08 feeling abnormal, confusional state Brain fog, confusion, plugged ears, sweating , 6 hours on first day March 8th after 1st dose of... Read more
Brain fog, confusion, plugged ears, sweating , 6 hours on first day March 8th after 1st dose of Moderna around 9 PM , Second day March 9th still some brain fog , plugged ears , and confusion , vomited that evening Third day March 10th I awoke with sudden loss of hearing in right ear , bit ears felt plugged I went to ENT dr. on March 11th who described me prednisone 60mg --tapered for 12 days Follow up on March 25th , no improvement on loss of hearing Suggested and MRI which I have not scheduled as of May 9th
65 2021-05-09 excessive sleepiness 04-22-2021 Woke up with severe chills at 3am; got extra covers and returned to sleep. Fever started ... Read more
04-22-2021 Woke up with severe chills at 3am; got extra covers and returned to sleep. Fever started around 7am and continued to high of around 102F at 2pm Muscle and joint aches; extreme fatigue Didn't eat Fever broke around 7pm; had chicken broth Slept for around 22 hours. 04-23-2021 Nominal fever 7am and for the day Off and on sweats Able to get up and about 04-24-2021 Recovered
65 2021-05-11 suicidal thoughts, feeling abnormal Abdominal pain; Monster headache; Arm sore at injection site; Suicidal ideation; Felt unstable/sitti... Read more
Abdominal pain; Monster headache; Arm sore at injection site; Suicidal ideation; Felt unstable/sitting on the couch like a zombie; Morbid thinking; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Suicidal ideation) in a 65-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 Bipolar disorder, Vasculitis and Depression. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced SUICIDAL IDEATION (Suicidal ideation) (seriousness criterion medically significant), FEELING ABNORMAL (Felt unstable/sitting on the couch like a zombie) and MORBID THOUGHTS (Morbid thinking). On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain), HEADACHE (Monster headache) and VACCINATION SITE PAIN (Arm sore at injection site). On 30-Apr-2021, SUICIDAL IDEATION (Suicidal ideation), FEELING ABNORMAL (Felt unstable/sitting on the couch like a zombie) and MORBID THOUGHTS (Morbid thinking) had resolved. At the time of the report, ABDOMINAL PAIN (Abdominal pain), HEADACHE (Monster headache) and VACCINATION SITE PAIN (Arm sore at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Treatment of these events included water and Anacin. Based on the current 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; 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 2021-05-13 delirium Headache turned to migraine I middle of night. Felt delirious , couldn?t even sip water, dry heaves,... Read more
Headache turned to migraine I middle of night. Felt delirious , couldn?t even sip water, dry heaves, extreme nausea, literally thought I was going to die, until after several hrs, was able to swallow an imitrex for migraines.
65 2021-05-13 feeling abnormal 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 2021-05-16 disorientation 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 amnesia, disorientation 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 impaired work ability 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 motion sickness 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 2021-05-21 amnesia stroke like systems including seizure, memory loss. Transported to emergency room at hospital via a... Read more
stroke like systems including seizure, memory loss. Transported to emergency room at hospital via ambulance . Following test performed; cat scan, IGG scan, and MRI with contras . No exact cause for the seizure was determined at this time.
65 2021-05-23 insomnia 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 2021-05-24 impaired work ability The first 4 days I had a high fever 101.3, I had the chills, body ache, extremely fatigue. That las... Read more
The first 4 days I had a high fever 101.3, I had the chills, body ache, extremely fatigue. That lasted from Sunday to Friday. Then for the next 2 to 4 weeks I was still fatigued, I could barely function at work. I started to lose weight. I work in a doctor?s office and I told the doctor that I did not feel well. I went from 108 to 99 pounds. In March I started to have the shakes and I went to see my PCP. He did not know what to do but he did bloodwork. The results the TSH went to 0.01 level. They increased my Tapazole for my thyroid. Two weeks later I got my blood drawn, TSH was even worse 0.005. He increased my does again of Tapazole. I had my blood drawn again 4 weeks later, no change in the TSH. The doctor stated she might have went into immune overdrive due to second dose of vaccine. She feels still so exhausted, and my muscle mass is gone. She is not able to do activities that she use to do.
65 2021-05-26 memory impairment 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 loss of personal independence in daily activities, feeling abnormal I had my sedrate checked a few weeks prior to my vaccination. It was 19 and I was doing great. I was... Read more
I had my sedrate checked a few weeks prior to my vaccination. It was 19 and I was doing great. I was vaccinated April 6 and began to feel really ill 2 days afterwards. I felt like I had the flu and all joints were red and painful. I had a hard time walking and the fatique was and still is extreme. After 6 days, April 12, I went to see my GP, I had labs and my sedrate had gone up to 79. I was re-tested on May 4 and it was 84. I will be retested in a week but I can tell it is still really high. I am not functional. I am in pain, I am so fatigued I am unable to do anything and I am unable to think clearly. Just making a grocery list or writing this feels like too much.
65 2021-05-28 restlessness Upon first Moderna vaccination (12/30/2020), day two rash occurred on chest area, lasted 3 days.. S... Read more
Upon first Moderna vaccination (12/30/2020), day two rash occurred on chest area, lasted 3 days.. Second Moderna vaccination within nine hours of vaccine,.....headache, leg aches, and body shakes from low grade fever, lethargic, but restless. Day two rash on chest and lasted 3 days.
65 2021-06-01 anxiety Pt called call center her left side of face getting very hot, specially her left ear feels more hot ... Read more
Pt called call center her left side of face getting very hot, specially her left ear feels more hot and pressure in it, stated her left eye also getting more red. Denies any itchy or fluids from eyes/ears. Pt stated these sx getting more started when she got back home after she got her 2nd dose covid vaccine Moderna around 1230pm today. Pt stated feeling anxious d/t possible s/e from covid vaccine she got. Pt's speech clear. ED precautions provided to patient. Urgent care visit scheduled for 4/30/21
65 2021-06-01 loss of personal independence in daily activities Couldn't lift arm or get of bed; Baker's cyst; Left knee has been swollen/leg feels heavy and diffic... Read more
Couldn't lift arm or get of bed; Baker's cyst; Left knee has been swollen/leg feels heavy and difficult to lift; Reactive arthritis flare; didn't receive the second dose,was advised not to; Stabbing pain in upper left arm, in the crease of arm/Stabbing pain in left elbow, right elbow, forearm, upper arm, left and right groin radiating down leg, sore arm; Excruciating joint pain; Fatigue; Severe body pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRITIS REACTIVE (Reactive arthritis flare) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Streptococcal sore throat from 12-Feb-2021 to 17-Feb-2021, Shortness of breath (The patient reported no significant change in the disease condition.) in 2006, Sciatica (The patient reported a significant change in the disease condition.) in 1995 and Elbow tendinitis (The patient reported a significant change in the disease condition.) in 2017. Concurrent medical conditions included Drug allergy (Biaxin, citalopram, venlafaxine, trimethoprim, sulfamethoxazole.), Hypothyroidism (The dose is lowered from 125 mg to 112) since 1988, Asthma (The patient reported no significant change in the disease condition.) since 01-Dec-2020 and Chronic obstructive pulmonary disease (The patient reported no significant change in the disease condition.) since 01-Dec-2020. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy, MONTELUKAST from 01-Nov-2020 to an unknown date for Asthma, FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) from 15-Jan-2021 to an unknown date for COPD and Asthma, PANTOPRAZOLE from 08-Jan-2021 to an unknown date and CIMETIDINE from 04-Jan-2021 to an unknown date for Hyperacidity, EZETIMIBE from 23-Jun-2020 to an unknown date for Hyperlipidemia, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, PENICILLIN NOS from 12-Feb-2021 to 22-Feb-2021 for Streptococcal sore throat, BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), CALCIUM, VITAMIN D3, VITAMIN E NOS, MAGNESIUM and VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]) from 04-Jan-2021 to an unknown date for an unknown indication. On 19-Feb-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Severe body pain), ARTHRALGIA (Excruciating joint pain) and FATIGUE (Fatigue). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Stabbing pain in upper left arm, in the crease of arm/Stabbing pain in left elbow, right elbow, forearm, upper arm, left and right groin radiating down leg, sore arm). On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose,was advised not to). On 14-Apr-2021, the patient experienced ARTHRITIS REACTIVE (Reactive arthritis flare) (seriousness criterion medically significant) and JOINT SWELLING (Left knee has been swollen/leg feels heavy and difficult to lift). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't lift arm or get of bed) and SYNOVIAL CYST (Baker's cyst). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form; GABAPENTIN ongoing since an unknown date at a dose of 200 mg; CELECOXIB (CELEBREX) at a dose of 200 mg; METHYLPREDNISOLONE ongoing since an unknown date at a dose of 4 mg; METHOCARBAMOL ongoing since an unknown date at a dose of 750 mg as required; FERUMOXYTOL (FERAHEME) ongoing from 06-May-2021 at a dose of 1 dosage form, first infusion; FERUMOXYTOL (FERAHEME) on 13-May-2021 at a dose of 1 dosage form, second infusion and CORTISONE ongoing since an unknown date at a dose of 1 dosage form. On 08-Apr-2021, PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose,was advised not to) had resolved. At the time of the report, ARTHRITIS REACTIVE (Reactive arthritis flare), PAIN (Severe body pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Couldn't lift arm or get of bed), SYNOVIAL CYST (Baker's cyst), JOINT SWELLING (Left knee has been swollen/leg feels heavy and difficult to lift), PAIN IN EXTREMITY (Stabbing pain in upper left arm, in the crease of arm/Stabbing pain in left elbow, right elbow, forearm, upper arm, left and right groin radiating down leg, sore arm), ARTHRALGIA (Excruciating joint pain) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Blood albumin (3.8-4.8): 3.7 (normal) 3.7g/dL. On 08-Mar-2021, Blood cholesterol: 172 (normal) 172 mg/dl. On 08-Mar-2021, Blood glucose (65-99): 88 (normal) 88mg/dl. On 08-Mar-2021, Blood iron (45-160): 39 (Low) Low. On 08-Mar-2021, Eosinophil count (15-500): 1003 (High) 1003 cells per microlitre. On 08-Mar-2021, Glycosylated haemoglobin increased: 6.0 (High) Unknown. On 08-Mar-2021, Haematocrit: 33.9 (Low) 33.9 %. On 08-Mar-2021, Haemoglobin (11.7-15.5): 10.6 (Low) unknown. On 08-Mar-2021, Mean cell haemoglobin (27.0-33.0): 25.2 (Low) unknown. On 08-Mar-2021, Mean cell haemoglobin concentration (32.0-36.0): 31.3 (Low) Unknown. On 08-Mar-2021, Platelet count (140-400): 396 (normal) Unknown. On 08-Mar-2021, Protein total (6.1-8.1): 5.7 normal. On 08-Mar-2021, Prothrombin time (9.1-1.2): 9.8 (normal) Unknown. On 08-Mar-2021, Red blood cell count (3.80-5.10): 4.21 (normal) unknown. On 08-Mar-2021, Red cell distribution width increased (11.0-15.0): 15.2 (High) Unknown. On 08-Mar-2021, Serum ferritin (16-288): 6 (Low) Unknown. On 08-Mar-2021, Thyroid function test: negative (Negative) thyroid was off.. On 08-Mar-2021, White blood cell count (3.8-10.8): 7.6 (normal) unknown. On 19-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 14-Apr-2021, Magnetic resonance imaging: unknown (Inconclusive) Bakers cyst and fluid on knee. On 26-Apr-2021, X-ray: unknown (Inconclusive) Left knee x-ray: Moderate joint effusion. On 10-May-2021, Magnetic resonance imaging: unknown (Inconclusive) Mild hand subcutaneous edema and unknown (Inconclusive) Mild diffuse flexor tenosynovitis from CMC joint level to metacarpal midshaft level. On 12-May-2021, Blood albumin (3.8-4.8): 3.6 (Low) 3.6g/dL. On 12-May-2021, C-reactive protein: 27.5 (High) Unknown. On 12-May-2021, Eosinophil count (15-500): 57 (normal) 57 cells per microlitre. On 12-May-2021, Haematocrit: 37.8 (normal) 37.8%. On 12-May-2021, Haemoglobin (11.7-15.5): 11.9 (normal) Unknown. On 12-May-2021, Mean cell haemoglobin (27.0-33.0): 25.4 (Low) Unknown. On 12-May-2021, Mean cell haemoglobin concentration (32.0-36.0): 31.5 (Low) Unknown. On 12-May-2021, Platelet count (140-400): 458 (High) Unknown. On 12-May-2021, Protein total (6.1-8.1): 6.6 (normal) Unknown. On 12-May-2021, Red blood cell count (3.80-5.10): 4.69 (normal) Unknown. On 12-May-2021, Red cell distribution width increased (11.0-15.0): 16.5 (High) Unknown. On 12-May-2021, White blood cell count (3.8-10.8): 8.1 (normal) Unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. The patient reported that she declined the administration of second dose and it was suggested by her physician. 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 report refers to a case of Product dose omission issue for mRNA-1273, lot # 007M20A with associated AEs. Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up received on 17-May-2021 and does not contain any new information On 21-May-2021: The second follow up received on 21-MAY-2021 and contain contact details of the reporter . The suspect drug dosage regime, medical history and events of the patient is updated.The concomitant and treatment medications are 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. This report refers to a case of Product dose omission issue for mRNA-1273, lot # 007M20A with associated AEs.
65 2021-06-02 impaired work ability, insomnia I went to get my shot at 3pm. After being vaccinated I sat about 30 mins in waiting room and nothing... Read more
I went to get my shot at 3pm. After being vaccinated I sat about 30 mins in waiting room and nothing happened. I then went home and when my husband and I were preparing to eat supper, I noticed I didn't have an appetite which was around 4:30 pm, We had our normal quiet evening at home and around 9 or 10pm I was watching tv. Normally If I don't fall asleep, I watch Law and Order because it's quiet and I can fall asleep. I watched tv all night until 7 in the am came and I was still awake I called in and told my job I would be there around 5 pm but would take the day portion of my shift off. Around 10 am I had a sharp headache with uncomfortable body aches and I was tired. I wasn't able to engage at all. My husband checked on me and I told him to turn the light out and not to touch me. I was in and out of sleep. I do recall having a glass of water around 3am. On the 3rd day I got up to get a glass of water and sat at the dining room table and I felt the symptoms were over. I heard the windows rattling similar to when we had a blizzard I also kept hearing a song playing and wondered why it was playing, It reminded me of a soft rock song from the 60's, I then realized I don't have a radio and the music was just playing in my head. I wasn't able to move for 3 days. I told my husband he should have called an ambulance and the next time something like this happens to call . I had back pain by the weekend and it caused me to hunch over. I went to the chiropractor at the end of the week they took an x-ray. I was advised my back was slight unaligned and this could be a possible result of previous back issues. Thursday night I didn't go to work which was not normal and my job was worried .I had my cellphone in my bed but I couldn't answer I was so out of it. My son who is 35 was vaccinated the day after me. He came downstairs to ask if we were playing jazz music. he heard the music playing as well but different from the type of music I was playing. My husband had zero symptoms, he was vaccinated at the same time as me.
65 2021-06-06 hallucination, amnesia Memory loss, can?t walk, incontient of bowel and bladder, hallucinations, no balance ,fine motor sk... Read more
Memory loss, can?t walk, incontient of bowel and bladder, hallucinations, no balance ,fine motor skills diminished,
65 2021-06-06 sleep disorder, feeling abnormal The evening I received the 2nd dose, I began having severe pelvic pain,bil. hip pain and stiffness, ... Read more
The evening I received the 2nd dose, I began having severe pelvic pain,bil. hip pain and stiffness, bil. hand pain and stiffness, right arm (deltoid) swelling, right axillary lymphadenopathy. I was unable to sleep for 36 hrs. The following day had fever, myalgia, severe epigastric pain, N/V. I felt awful for about 5 days (pains continued, fatigue and low grade fevers) and then had an acute renal calculi and ED visit on 03/3/2021.. To date, (6/7/21), I continue to have bil. hip pain and stiffness, pelvic pain. Left gastrocnemius is painful and stiff also.
65 2021-06-07 feeling abnormal Any movement gave her shortness of breath/All of her breath was gone/The shortness of breath went on... Read more
Any movement gave her shortness of breath/All of her breath was gone/The shortness of breath went on for 2 weeks and would happen whenever she walks,does/she has shortness of breath/can not exercise without experiencing shortness of breath; Chest congestion; wheezing at night; worsening chest congestion; Headache; Worsening cough/coughing; she could not get warm even with an electric heat pad,; chills for three days; she believes she had anaphylactic reaction to the vaccine; runny nose; her face is swollen; She thought she was going to die/ her forehead was killing her; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Any movement gave her shortness of breath/All of her breath was gone/The shortness of breath went on for 2 weeks and would happen whenever she walks,does/she has shortness of breath/can not exercise without experiencing shortness of breath), PULMONARY CONGESTION (Chest congestion), CONDITION AGGRAVATED (worsening chest congestion) and ALLERGY TO VACCINE (she believes she had anaphylactic reaction to the vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 025B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Congestion pulmonary and Exercise regular. Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) 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 DYSPNOEA (Any movement gave her shortness of breath/All of her breath was gone/The shortness of breath went on for 2 weeks and would happen whenever she walks,does/she has shortness of breath/can not exercise without experiencing shortness of breath) (seriousness criterion hospitalization), ALLERGY TO VACCINE (she believes she had anaphylactic reaction to the vaccine) (seriousness criterion medically significant), FEELING COLD (she could not get warm even with an electric heat pad,), RHINORRHOEA (runny nose), SWELLING FACE (her face is swollen), FEELING ABNORMAL (She thought she was going to die/ her forehead was killing her) and CHILLS (chills for three days). On 03-Apr-2021, the patient experienced COUGH (Worsening cough/coughing). On 05-Apr-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced PULMONARY CONGESTION (Chest congestion) (seriousness criterion medically significant), CONDITION AGGRAVATED (worsening chest congestion) (seriousness criterion medically significant) and WHEEZING (wheezing at night). At the time of the report, DYSPNOEA (Any movement gave her shortness of breath/All of her breath was gone/The shortness of breath went on for 2 weeks and would happen whenever she walks,does/she has shortness of breath/can not exercise without experiencing shortness of breath), PULMONARY CONGESTION (Chest congestion), CONDITION AGGRAVATED (worsening chest congestion), ALLERGY TO VACCINE (she believes she had anaphylactic reaction to the vaccine), FEELING COLD (she could not get warm even with an electric heat pad,), WHEEZING (wheezing at night), RHINORRHOEA (runny nose), SWELLING FACE (her face is swollen) and FEELING ABNORMAL (She thought she was going to die/ her forehead was killing her) outcome was unknown, COUGH (Worsening cough/coughing) had not resolved and HEADACHE (Headache) and CHILLS (chills for three days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable. Steroids were used as one of the concomitant medications for wheezing and shortness of breath. Based on the current 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 fact that the patient experiences shortness of breath before both doses of vaccination could be a possible confounder and could suggest a prior relevant medical condition. This case was linked to US-MODERNATX, INC.-MOD-2021-089474 (E2B Linked Report). This case was linked to MOD-2021-089474 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional information was received on 26 May 2021 which includes the following new information: New events added, dosage details updated, action taken updated and reporter 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. The fact that the patient experiences shortness of breath before both doses of vaccination could be a possible confounder and could suggest a prior relevant medical condition.
65 2021-06-08 sleep disorder 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 2021-06-10 loss of personal independence in daily activities Rolled over the following morning and experienced vertigo, which caused me to projectile vomit. A we... Read more
Rolled over the following morning and experienced vertigo, which caused me to projectile vomit. A week later, I fell on my head. The hospital did a complete workup and all of the tests were negative. The vertigo got progressively worse to where I couldn't function. I couldn't drive, turn my head, roll over or reach. I pretty much vomited every time I moved and I had to be careful that I didn't trip or lose my balance. I had a few visits with my PCP and was given nausea meds. I then saw a physical therapist and was taught Espley maneuvers to correct the vertigo. I went to PT for about 4 or 5 weeks. I had a few episodes afterwards, but I just did the exercises and took care of it at home.
65 2021-06-13 feeling abnormal, disturbance in attention, disorientation, memory impairment Exactly four hours after the second vaccination for covid, I felt very tired and dizzy. I felt seve... Read more
Exactly four hours after the second vaccination for covid, I felt very tired and dizzy. I felt severely disoriented and had to go to bed. One day later I had a terrible headache (April 7) Over the next six weeks I had forgetfulness and trouble concentrating while driving. I felt like the vaccine altered my brain. On May 19, I had the extreme foggy brain feeling again similar to the feeling on April 6. I had a dementia type instance for the first time and went to the wrong wall to turn on a light switch in the home that we built and I know exactly where everything is because I decided where everything was installed. On June 2 I had a moment driving where I didn't know how to turn a u-turn in an intersection that I use all the time. Ever since my second covid shot I feel as if my brain was altered.
65 2021-06-13 excessive sleepiness I had fever of almost 101, chills, very tired, I slept for almost 24hrs, bad headache, nauseated, vo... Read more
I had fever of almost 101, chills, very tired, I slept for almost 24hrs, bad headache, nauseated, vomiting.
65 2021-06-14 confusional state, feeling abnormal Brain fog/confusion , ear fullness , vomiting once and woke with sudden hearing loss in right ear ... Read more
Brain fog/confusion , ear fullness , vomiting once and woke with sudden hearing loss in right ear ongoing loss of hearing as of 6/15/2021 Treatment prednisone for 2 weeks then again 3 months later , no improvement .
65 2021-06-14 loss of personal independence in daily activities 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 2021-06-16 depression, insomnia At 4pm on 03/12 the day of the shot I was out walking and I got a stabbing pain in both eyes. I had ... Read more
At 4pm on 03/12 the day of the shot I was out walking and I got a stabbing pain in both eyes. I had to cover my eyes walking home and after that I had severe light sensitivity and eye pain. Its just now getting better three months later. So I went to the doctor who is an ophthalmologist. My vision was not effected as far as what I could see and couldn't see. He prescribed prednisolone drops for three weeks with no response. Then I had 3 more weeks and then for the last week or so I've been getting better. I didn't go see him for about a month because I thought it would go away. I saw him on April 9th and May 20th. I still have to wear sunglasses indoors if there is any bright light. My eyes before felt swollen inside and it was very painful especially with light. I use regular over the count eye drops for dryness. Its new and I've never had this happen before. I use them about 6 to 8 times a day. On 03/14/2021 in the morning I got slammed with incredible fatigue. Mine lasted for months after three months I'm less fatigued probably by 50%. The fatigue was nauseating. In March I was agitated with the fatigue. I had difficulty sleeping and I two weeks of profound depression. After two weeks it was gone. The fatigue has lasted until now, I have to sleep for 9 hours plus naps. I'm a very energetic person until this shot. So this is a big change for me.
65 2021-06-16 insomnia, sleep disorder Pulsating tinnitus. Starting May 5 duration 2-3 hours, recurred several times a week. Subsided May 2... Read more
Pulsating tinnitus. Starting May 5 duration 2-3 hours, recurred several times a week. Subsided May 29. Returned June 10 for a few hours. Recurred June 17 and woke me from sleep. Causing insomnia. So far pulsing has lasted 6 hours.
65 2021-06-17 insomnia, impaired work ability excruciating pain/vaccine symptoms hurt 20 times more; cannot sleep or do anything; cannot lift a pi... Read more
excruciating pain/vaccine symptoms hurt 20 times more; cannot sleep or do anything; cannot lift a piece of paper; completely disabled right now and cannot go to work; vaccine rash (large patch); cannot go to work/ can not do anything; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (excruciating pain/vaccine symptoms hurt 20 times more), INSOMNIA (cannot sleep or do anything), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift a piece of paper), MALAISE (completely disabled right now and cannot go to work), VACCINATION SITE RASH (vaccine rash (large patch)) and IMPAIRED WORK ABILITY (cannot go to work/ can not do anything) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 028A21A) for COVID-19 vaccination. The patient's past medical history included Arthritis and Knee surgery NOS. On 08-Apr-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 an unknown date, the patient experienced PAIN (excruciating pain/vaccine symptoms hurt 20 times more) (seriousness criterion disability), INSOMNIA (cannot sleep or do anything) (seriousness criterion disability), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift a piece of paper) (seriousness criterion disability), MALAISE (completely disabled right now and cannot go to work) (seriousness criterion disability), VACCINATION SITE RASH (vaccine rash (large patch)) (seriousness criterion disability) and IMPAIRED WORK ABILITY (cannot go to work/ can not do anything) (seriousness criterion disability). At the time of the report, PAIN (excruciating pain/vaccine symptoms hurt 20 times more), INSOMNIA (cannot sleep or do anything), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift a piece of paper), MALAISE (completely disabled right now and cannot go to work), VACCINATION SITE RASH (vaccine rash (large patch)) and IMPAIRED WORK ABILITY (cannot go to work/ can not do anything) outcome was unknown. Concomitant product use was not provided. Symptoms started 7 days after the shot and lasted 2.5-3 weeks. Patient wanted to knowif could take paracetamol to treat symptoms. The vaccine symptoms hurt 20 times more. 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. This case was linked to -MOD-2021-072900 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR - reporter/patient name obtained.; 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-2021-072900:
65 2021-06-19 feeling abnormal Brain fog for several days. Multiple Papules along right arm and left forearm. Open weeping blister... Read more
Brain fog for several days. Multiple Papules along right arm and left forearm. Open weeping blisters on right arm. Open weeping blisters on left middle finger. Approximately seven days after the first injection. The area continued to show signs of infection. Cellulitis around forearm. Temperatures reaching 100° During the evening hours. Rash on neck and face approximately seven days after the second injection on 6/8/2021. Went to Dr on 6/15/2021 and was given RX prednisone 40 mg QD x 5 days and Doxycycline 100mg BID x7 days
65 2021-06-21 anxiety, depression, sleep disorder 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 2021-06-22 fear 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 insomnia 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 2021-06-24 excessive sleepiness Extreme fatigue, headache, sore throat, and high fever. The high fever ran for a few days. I had no ... Read more
Extreme fatigue, headache, sore throat, and high fever. The high fever ran for a few days. I had no appetite. I slept a lot.
65 2021-06-26 loss of personal independence in daily activities Shoulder joint & muscle pain at injection site. Unable to lift arm or lift weight with hand/ Arm
65 2021-06-28 feeling abnormal Patient called 6-27-21 requesting to speak with the pharmacist regarding a medication. upon question... Read more
Patient called 6-27-21 requesting to speak with the pharmacist regarding a medication. upon questioning, the patient reported she was still experiencing side effects from her Moderna Covid-19 vaccine and that she had a significant reaction starting the day after her vaccine was administered. According to the patient, she had tingling lips and felt unusually energetic after the vaccine similar to a manic episode of bipolar disorder. She also reporting starting to have uncontrollable chills. The next day she felt "like a wet towel" where she felt so bad she couldn't talk. She also reported aches and pains, chills, sweating, nausea and vomiting, and clear, watery diarrhea. She also mentioned she stopped urinating probably due to dehydration. Patient reported stopping her medications due to not being able to keep them down. On 6-25-21 the patient went to the hospital to be treated. She said she was given IV treatment including fluids and Zofran. They also gave her Keppra because she has a history of seizures and had stopped her medications. Patient began to feel better and was able to eat and start her medications again so she was discharged and sent home with Zofran tablets. She also reported taking Imodium tablets for the diarrhea. She states she has been feeling well recently, but is still having chills (shivering). She asked whether she could take more Zofran than prescribed and whether she should start her other medications again because she was worried about upsetting her stomach. I told her I cannot recommend she take her medication other than prescribed and I encouraged her to restart her medication due to her history of seizures. I also told her to call her doctor again on Monday to see if they have any other recommendations or concerns.
65 2021-06-28 impaired work ability Call from Patient who states she had her Covid Vaccines here and is now being evaluated for a "lump"... Read more
Call from Patient who states she had her Covid Vaccines here and is now being evaluated for a "lump" at the injection site. Patient states her L. arm has been sore since the last injection and since it is starting to affect her ability to work as a physical therapist, she went to see her Dr. She saw a Nurse Practitioner at the first visit, who felt a lump at the injection site and ordered an U/S, which has been scheduled, but not yet done.
65 2021-06-29 loss of personal independence in daily activities February 24th I woke up with stabbing pain in my upper left arm. Over the next few days, I had sharp... Read more
February 24th I woke up with stabbing pain in my upper left arm. Over the next few days, I had sharp stabbing pain in my right and left elbow, forearm, upper arms, and right and left groin area radiating down to my legs. I had blood work with my PCP. He determined that my thyroid was high. The pain was intense. I couldn't lift my arms or get out of bed. I decided not to get the 2nd vaccine because of that. March 25th the pain started in my legs, and I couldn't lift my legs high enough to get up the stairs. I had swelling in April. April 15th I had swelling in my hands and fingers. I couldn't feed myself. All of this came and went. I went to see my new PCP. My left and right knees had swollen pretty badly, I had an MRI of my left knee because the swelling wouldn't go down. It was determined I had rheumatoid arthritis. I was put on methotrexate 1 x week. I haven't had new episodes but my left knee and left shoulder is the worst. The doctor removed fluid from them. I have a Bakers cyst on my left knee. I have been having a brain fog over the past couple months. It was determined I had ground glass in both lungs. I have been taking Celebrex, Methocarbamol, Tylenol, Gabapentin, and Methotrexate since I received the vaccine.
65 2021-07-01 impaired work ability, loss of personal independence in daily activities I already had a little bit of swelling in my left hand from the first dose of the vaccine, but withi... Read more
I already had a little bit of swelling in my left hand from the first dose of the vaccine, but within about 8 hours my left hand swelled up and both hands became painful. It went into my wrist and I had trouble bending my fingers. I knew very quickly something was going on. I am a very healthy person and never have problems and I am able to function very well for my age. I knew pretty quickly that something wasn't right. I muddled through work the next week and only worked 28 hours and I haven't been able to maintain that schedule because of the pain. I bought arthritis cream because of the pain in the night. By the next Friday (05/21/2021) I tried to reach out to the doctor and got an appointment within a week and she ran blood tests. She did a rheumatoid test. Blood test came back as some type of autoimmune disease and she also tested for lupus and part of the autoimmune response problem was basically that this could be Lupus-SLE. She hooked me up with a specialist and I saw them on Tuesday and they ran blood tests and I don't have those results yet. It radiates into my shoulder sometimes that incapacitates me. I have trouble with everything even cutting a pancake and raw vegetables. I have debilitating pain and jolts of electric pain especially in right fingers. It's been a life changing event. I've had to be so dependent on people at work. I am exhausted by the time I do get ready for work. In the morning I can't even shower because my hands aren't flexible enough to roll my hand around the wash cloth. I took a pic of my hand the night after vaccine and people who saw my hand couldn't believe what my hand looked like. The one thing I've learned that does help is a little bit of hand exercises in the pool, movements up and down and back and forth, water resistant but that is very temporary. On May 1 I came home from a trip and May 2 in addition to my left hand being swollen, my ankles were swollen after a flight. I've traveled around the world as a flight attendant and never had this issue. My ankle swelling went down but not my hands. I also had joint pain.
65 2021-07-04 anxiety Multiple gastrointestinal issues including colitis, severe stomach pain, nausea, tremors, anxiety, h... Read more
Multiple gastrointestinal issues including colitis, severe stomach pain, nausea, tremors, anxiety, headaches, weight loss starting 5-7 days after receiving the vaccine and has continued until now; symptoms are slowly improving
65 2021-07-05 feeling abnormal This happened 4 days after the vaccine. I just took Tylenol since they told us it was best to take i... Read more
This happened 4 days after the vaccine. I just took Tylenol since they told us it was best to take instead of Advil. It was such a weird feeling because it was in my arm, between my bicep and forearm, not the joint or elbow, just the bone area, general weakness, like a dull pain in my arm, it was not a muscle thing, it was a strange sensation for a couple days, I was afraid I was gonna drop the dishes because it was so weak. Then it went away, but it keeps happening randomly. I have it off and on. It was pretty persistent in the beginning. I mentioned the situation to my doctor and did not prescribed anything, I just asked if she had heard about this symptoms and she said no.
65 2021-07-05 nervousness 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 delirium, loss of personal independence in daily activities, insomnia, feeling abnormal, fear, confusional state, anxiety, sleep disorder 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 2021-07-07 excessive sleepiness I had fever, chills, lack of appetite. I slept a lot. Main thing was the fever. I experienced that f... Read more
I had fever, chills, lack of appetite. I slept a lot. Main thing was the fever. I experienced that for 2 and a half days.
65 2021-07-08 feeling abnormal Pt states shoulder looks/feels like an apple. started late day two. It is now day three.
65 2021-07-15 feeling abnormal Very tired at 10pm. Woke up at 1am in severe pain all over body- skin, muscles and joints. Mild So... Read more
Very tired at 10pm. Woke up at 1am in severe pain all over body- skin, muscles and joints. Mild Sore throat and headache. Very weak and hard to walk without feeling faint. Felt horrible all day until about 7-8 pm.
65 2021-07-17 disorientation, irritability Severe rash, headache, chest pain, shortness of breath, irritability, disoriented
65 2021-07-17 loss of personal independence in daily activities Usual, expected side effects for a day or 2. Flu like, chills, temp, headache extreme fatigue, muscl... Read more
Usual, expected side effects for a day or 2. Flu like, chills, temp, headache extreme fatigue, muscle aches. Severe headaches and extreme exhaustion, lethargy, occasional temp, first identified at the beginning of April. Difficult in daily functioning.
65 2021-07-17 sleep disorder Within 25 minutes of 2nd Moderna dose, the left side of my neck and back center of neck started to f... Read more
Within 25 minutes of 2nd Moderna dose, the left side of my neck and back center of neck started to feel like it was being constricted. Began taking Aleve 2/day (rather than just 1 Aleve per week or less for lumbar arthrosis). Next few days, didn't feel great. The worst part was my neck. I couldn't understand why I now had constant stiff and achy neck. By week 4, started waking up with occasional right side of body being numb (arm, hand, leg). This had never before happened in my lifetime. By week 13, severe left leg cramping and pain from thigh to knee to shin to calf. Out of nowhere, my left top of foot looked swollen. In addition, my right hand middle finger ached. Was getting 2 hrs of sleep for 10 d
65 2021-07-18 confusional state 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 2021-07-21 anxiety, sleep disorder As I was driving home shortly after my shot, I felt unusually tired, so much so that I wanted to fal... Read more
As I was driving home shortly after my shot, I felt unusually tired, so much so that I wanted to fall asleep at the wheel. When I got home, I had a lie-down and fell fast asleep. Later, I was awoken from my sleep by pain and the injection site. I put an ice pack on it, and the pain intensified. The pain was such that I was in and out of sleep all night long; I couldn't get a sound sleep on account of the pain. The following day when I woke up, I found it excruciatingly painful to raise my left arm. I took two Tylenol and then noticed that the muscles in my legs were extremely sore. I found it painful to walk. My legs felt like they had run a marathon! I ended up using a walker for about 2 1/2 weeks. I had already dealt with chronic pain, but this wasn't normal for me, so I called the doctor. She told me to wait a few more days and to come to the clinic if it didn't subside. Ultimately, I didn't go to the clinic. About 3 weeks after the leg pain began, the pain finally began to subside. During these three weeks, not only did I have leg pain and a sore injection site, but I also felt extreme malaise and weakness. I also experienced great anxiety, for which my doctor prescribed a 3-day supply of the lowest dose of lorazepam. During the time that I received the vaccine, I was already taking methylprednisolone to treat my RA and fibromyalgia. The inflammation in my body was also high. I now wonder if the interaction of the vaccine and methylprednisolone exacerbated the inflammation.
65 2021-07-21 disorientation, sleep disorder I woke up in the middle of the night with a terrible migraine. I don't usually get headaches. It got... Read more
I woke up in the middle of the night with a terrible migraine. I don't usually get headaches. It got to the point that I was being woken up every night with migraines that lasted about 45 mins. This lasted for 23 days exactly. I finally contacted my PCP. She said that she thought I should get my 2nd dose. I didn't have fever, chills, or any other symptoms. I did feel really tired. My doctor gave me some sleeping pills to take because I was getting up 2-3 times a night because of my headaches. I decided not to take them though. I never took any of them. I just sucked it up and prayed that it would end soon. After the 23 days, my headaches finally gradually slowing. I pretty much just sucked it up until about the last 5 days and that is when I contacted my PCP. I just couldn't take it anymore. They gradually started to go away after that. I started getting them twice during the day, and once at night. I was getting them 3-4 times during the day and 2-3 times at night. The migraines were so bad that I would get very dizzy. I was very disoriented. After about 27-28 days total, I did not have them anymore.
65 2021-07-24 feeling abnormal 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 2021-07-25 sleep disorder Extreme pain at injection site. Limited ability to move arm, excruciating pain I trusting sleep patt... Read more
Extreme pain at injection site. Limited ability to move arm, excruciating pain I trusting sleep patterns. Unable to put weight on arm
65 2021-07-26 loss of personal independence in daily activities She got the vaccine and within 3-4 hours both arms started hurting, and got worse as the day went on... Read more
She got the vaccine and within 3-4 hours both arms started hurting, and got worse as the day went on. After about 6-8 hours later she could not move her arms without unbelievable pain, and could not move her arms up towards her shoulder without extreme pain and could not move then sideways. She could not put her arms on the recliner and had to keep them besides herself. Could not move her arms to brush her teeth or put a drink on the table due to the pain. She had to sleep in the recliner as she could not lay in bed without her arms hurting. I slept for about 12 hours to escape the pain and by the next evening about a day and a half later the pain started easing up a little bit, and got more range of motion in her arms. She could lift them up a little bit more and a little sideways. She did not take anything for it, just slept. The first day and a half was bad. She could move her fingers and hands, but not the arms themselves. She has a push button recliner and could not use that and then tried her unvaccinated arm and could not move it as it felt like the muscles were twisting. She was extremely tired and slept another 12 hours, and then 2 days later the pain and the range of motion got better and progressively improved. She was able by Monday to dress and undress herself and the toothache type pain was gone. The pain and symptoms lasted for about a total of 4-5 days and then had soreness. By the time she received the 2nd vaccine she was okay. She did have normal reactions to the 2nd vaccine, was sore and felt that her lymph nodes were swollen, and feels that sometimes it may still be.
65 2021-07-27 amnesia Pain manifested in the right arm; Feeling pain in her left ankle/Pain quickly reached her sheen and ... Read more
Pain manifested in the right arm; Feeling pain in her left ankle/Pain quickly reached her sheen and knee/Ice cold pain; Pain spread to the other side of the body; Pain; Osteoarthritis; Loss of memory; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis) 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. No Medical History information was reported. Concomitant products included ATORVASTATIN, CLONAZEPAM and BUPROPION HYDROCHLORIDE (WELLBUTRIN) 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 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced AMNESIA (Loss of memory). On 17-Jul-2021, the patient experienced OSTEOARTHRITIS (Osteoarthritis) (seriousness criterion disability) and PAIN (Pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain manifested in the right arm), ARTHRALGIA (Feeling pain in her left ankle/Pain quickly reached her sheen and knee/Ice cold pain) and MYALGIA (Pain spread to the other side of the body). At the time of the report, OSTEOARTHRITIS (Osteoarthritis), AMNESIA (Loss of memory), PAIN IN EXTREMITY (Pain manifested in the right arm), PAIN (Pain), ARTHRALGIA (Feeling pain in her left ankle/Pain quickly reached her sheen and knee/Ice cold pain) and MYALGIA (Pain spread to the other side of the body) outcome was unknown. Treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable For mRNA-1273 (Moderna COVID-19 Vaccine)( Intramuscular), the reporter did not provide any causality assessments. Laboratory investigations performed included blood test, MRI (Magnetic resonance imaging), urine test and X-Ray test all performed on an unknown date whose results are not provided. Additional information reported included that the patient visited emergency room on 17 Jul 2021. The patient also reported that pain started to manifest the right arm and she had to keep it in a certain position for it to subside. 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 regarding this events has been provided at this time. No further information is expected at this time This case was linked to MOD-2021-265771 (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 regarding this events has been provided at this time. No further information is expected at this time
66 2020-12-31 sleep disorder I woke up in the middle of the night to an ache in upper left arm with itching. On examination I sa... Read more
I woke up in the middle of the night to an ache in upper left arm with itching. On examination I saw a slightly raised red welt about 3 inches in diameter. i went back to sleep and in the morning woke with slight body aches and lethargy, welt on arm still there. My temperature has been low grade (99.2) . Still feeling lousy and arm is still inflamed.
66 2021-01-02 excessive sleepiness Received vaccine on Thursday arm was sore on Friday, Saturday morning @5:OO AM woke with horrendous ... Read more
Received vaccine on Thursday arm was sore on Friday, Saturday morning @5:OO AM woke with horrendous headache and slept most of the day, very tired. Woke in the middle of the night to go to the bathroom and had horrible vertigo actually bouncing off the walls. Took Meclizine and benadryl for relief. Wondering what my immune system will do on the second dose!
66 2021-01-05 anxiety 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 2021-01-05 feeling abnormal Severe pain in left arm. Felt like arm had been wrenched from shoulder socket. Pain radiated down ... Read more
Severe pain in left arm. Felt like arm had been wrenched from shoulder socket. Pain radiated down arm from shoulder to wrist. Could not lift arm more than halfway to the front or side for 3 days. Took 6 days for all pain to dissipate.
66 2021-01-10 impaired work ability Myalgia, Arthralgia, Fever & CoughWheeze Narrative: Self care provided with lost work time
66 2021-01-12 feeling abnormal Brain fog and fatigue on day 1 and 2 after administration. Diarrhea and extreme fatigue beginning o... Read more
Brain fog and fatigue on day 1 and 2 after administration. Diarrhea and extreme fatigue beginning on day 7 and today (day 8). COVID test negative yesterday. Plan another test tomorrow. I am an RN at the Health Center on campus. Unsure if the latter symptoms are adverse event to vaccine, but felt it should be reported.
66 2021-01-12 impaired work ability On 1/8/2021, at 8:00 PM, patient began to experience a low-grade fever, chills, body aches, muscle a... Read more
On 1/8/2021, at 8:00 PM, patient began to experience a low-grade fever, chills, body aches, muscle aches, cramps in arms and legs, nausea, fatigue and shivering. At 4:00 AM on 1/9/2021, patient awoke with extreme fatigue, diminished eye-sight - describes as vision being "grey and mottled", and impairment of gait - stumbling when attempting to walk. Patient was scheduled to work that morning and had to call off due to these symptoms she was experiencing. **This was reported on 1/12/2021, at which time, the patient stated that she was currently experiencing a loss of taste and smell, and had tested positive for COVID-19 that morning.**
66 2021-01-18 excessive sleepiness 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 2021-01-18 insomnia Started with chills, followed by headache, nasseau, vomiting, fatigue, muscle aches and insomnia. T... Read more
Started with chills, followed by headache, nasseau, vomiting, fatigue, muscle aches and insomnia. The chills receded by 11:00. I vomited at 5:30 AM and could sleep. The other symptoms lasted until 1/15 during the night. Was fatigued and ill feeling through 1/16. On 1/17 I woke up feeling much better and was able to resume normal activities. Very minimal pain in left arm (site of injection).
66 2021-01-21 anxiety Pt received vaccine at 8:39 AM. Pt states she begins to feel anxious and also notices her heart rate... Read more
Pt received vaccine at 8:39 AM. Pt states she begins to feel anxious and also notices her heart rate to be 120 in her watch. Pt is monitored in the recovery area located inside. VS at 8:52 are HR 99, O2 98%, BP 140/85. Pt states she did not take her blood pressure medications in the morning. At 9:01 her heart rate is 88. At 9:06 BP is 140/80 and HR is 80. Pt is calm and states she feels better and is okay to drive home.
66 2021-01-21 sleep disorder Unable to sleep that night, up and down all night long (Melatonin and tea did not help) Chills Fever... Read more
Unable to sleep that night, up and down all night long (Melatonin and tea did not help) Chills Fever Nausea Major Headache (took Acetaminophen and Ibuprofen but neither helped)
66 2021-01-22 feeling abnormal After about 2 hours, felt like in a fog ... then at about 6 hours started feeling joint stiffness, ... Read more
After about 2 hours, felt like in a fog ... then at about 6 hours started feeling joint stiffness, achy in upper back, shoulders areas, of course soreness at injection site but not severe. No at about 20 hours post-vaccine, achy in upper back, shoulders areas worsened, but still not severe, soreness at injection site the same.
66 2021-01-23 feeling abnormal Hurt badly when shot given. Shoulder sore for 48 hours. Neck sore 12 hours after shot. Injection sit... Read more
Hurt badly when shot given. Shoulder sore for 48 hours. Neck sore 12 hours after shot. Injection site was hot to touch for 12 hours. Two days later and I still feel dragged-out and no energy
66 2021-01-23 nervousness 1 week after receiving the vaccine she developed a large hive to the injection site and she has deve... Read more
1 week after receiving the vaccine she developed a large hive to the injection site and she has developed a few small additional hives to her left upper chest the past week. Areas of hives are mildly itchy. She states she is very nervous about this and thinks that her anxiety has contributed to making her feel intermittent mild shortness of breath and yesterday she had a mild right-sided headache & 1 episode of diarrhea that resolved. She received to the vaccine at clinic. She has an allergy to sulfa drugs that gives her hives. She reviewed the ingredients in the Moderna vaccine and it does not seem to contain any sulfa. She has not taken any medications for these symptoms.
66 2021-01-23 sleep disorder pt came yest to get 2nd vaccine. Pt during the night 1030pm became sick ? chills, fever, then 2am di... Read more
pt came yest to get 2nd vaccine. Pt during the night 1030pm became sick ? chills, fever, then 2am diarrhea, 430 am dry heaves, body aches; took a phenergan, it helped some early this am. Pt resting now, but hardly slept all night. Woke up 4am with dry heaves. Went back to bed and 830am woke up again with dry heaves. Now resting but nausea and chills.
66 2021-01-24 nervousness Feeling of warm wave, then very shaky. EMT?s reported BP 190 and heart rate 156. By evening the si... Read more
Feeling of warm wave, then very shaky. EMT?s reported BP 190 and heart rate 156. By evening the site was very painful with a swollen red welt. Redness has lasted over a week. Pain gone after 6 days. Stared itching 2 days after injection.
66 2021-01-25 feeling abnormal, insomnia, insomnia, feeling abnormal 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 2021-01-26 sleep disorder After shot was administered, the band aid was filled with blood. I was feeling a great deal of soren... Read more
After shot was administered, the band aid was filled with blood. I was feeling a great deal of soreness immediately. my arm at the injection site is tender to the touch and my shoulders and neck are sore too. I started with 99 fever Monday night and Tuesday night I experienced sweats and clamminess. I couldn't sleep. When I awoke Wednesday morning, I had 100.5 fever. I took Tylenol and a couple of hours later, fever went to 99. 2. I will continue to take Tylenol every few hours.
66 2021-01-28 insomnia, confusional state, sleep disorder, anger Initially had tingling in left fingers about 30 minutes following injection which resolved with mov... Read more
Initially had tingling in left fingers about 30 minutes following injection which resolved with movement of arm, hand and fingers. Fatigue later that evening; 1/6/2021 arm soreness, fatigue came in waves, muscle soreness, some minor mental confusion; 1/7/2021 temp 99.1, headache, waves of fatique, early to bed slept 12 hours; 1/8-1/11/2021 balance slightly off plus above issues declining; 1/12/2021 swollen lymph nodes in left armpit, slight soreness left arm at injection site; 1/13/2021 gradual increased left arm soreness at injection site; 1/14/2021 left arm - red, swollen, warm to touch, painful; contacted provider of injection; 1/15/2021 as above, headache, left hand pins/needles, prescribed dexamethasone daily & cephalexin BID, both for 7 days; 1/16/2021 numbness slightly improved, left hand began to itch, swelling improved slightly, redness improved; 1/17/2021-1/21/2021 gradual improvement continued, swelling in arm disappeared, slight numbness remained; headache & fatigue continued but was improved, very little sleep ~ 3-4 hours nightly; 1/21/2021 saw allergist for recommendations for upcoming 2nd dose - suspected was similar to surgical dye reaction and provided recommendations for next dose. 1/22/2021 finished dexamethasone and cephalexin; slight left hand numbness remained, headache began late in day; 1/23/2021 headache, confusion, anger, balance continued and worsened through day, both hands & feet pins/needles; difficulty holding full glass with one hand; extreme fatigue, slept off/on throughout the day; 1/24/2021 as above, left arm sore at injection site with a hard lump, less anger. vision & hearing off, slight nausea off/on, insides vibrating and won't stop, left side of lower mouth slightly numb, heart racing at times. all symptoms worsen as day progresses; 1/25/2021 as above, left arm stinging at times, very slight improvement with mental confusion; 1/26-1/27/2021 continue to have pins/needles in hands/feet but comes & goes, sleeping 10-14 hours throughout the day; vision & hearing still off, afternoon of 27th had total exhaustion, body like jello, catatonic like state, middle of night awoke with same exhaustion symptoms; 1/28/2021 prescribed dexamethasone for 14 days, diazepam in AM, diazepam in PM prn & citalapram daily; Citalapram caused adverse reaction.
66 2021-01-29 sleep disorder On January 29 I had itching on my left arm, where the shot was given. I had splotches of redness. ... Read more
On January 29 I had itching on my left arm, where the shot was given. I had splotches of redness. My am was swollen. During the day it felt hot and the itching increased. It was sensitive to my touch. It was not comfortable sleeping on my left side. On January 30 I now have a circle of redness (like the pictures of people on the internet, called Covid arm). My arm still itches. It is still sensitive to my touch. It is not as warm as yesterday.
66 2021-01-30 sleep disorder Side effects awakened me from sleep with onset of chills, aches in muscles and joints and headache. ... Read more
Side effects awakened me from sleep with onset of chills, aches in muscles and joints and headache. Later developed nausea. Fatigue aches in muscles and joints persisted until 1/31/21 am. Headache persisted from onset of symptom on 1/30/21 until approximately 10:30 am on Sunday 1/31/21. I did not seek medical attention, as I am a health care provider and was aware that these were common side effects of the vaccine.
66 2021-01-31 feeling abnormal, confusional state 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 2021-01-31 feeling abnormal Moderna COVID-19 Vaccine EUA For the first 8 days, I experienced no reaction to the vaccine. On da... Read more
Moderna COVID-19 Vaccine EUA For the first 8 days, I experienced no reaction to the vaccine. On day 9, I developed a rash on my right arm surrounding the vaccination site. I was also flushed and my eyes were red. And, I experienced diarrhea. I began taking Benadryl 25mg every 4 hours during the day (and took zolpidem only at night). In the subsequent 4 days, In addition to the rash, I experienced minor headaches and body aches (not unusual with my Fibromyalgia) so I added Tylenol 500 mg every 6 hours. The rash remained the same. Today is Day 5 and I awoke feeling better and the rash is the same size but not as vibrant. I used a cortisone cream on the rash today and only took Benadryl once when I began to feel lousy at the end of my work day.
66 2021-01-31 feeling abnormal Pain at injection site, muscular aches, fatigue, headache, fogginess, rosacea outbreak,
66 2021-01-31 mental impairment, feeling abnormal, sleep disorder Moderna COVID-19 Vaccine EUA, after waiting 15 minutes after vaccine, I left and stopped at a rest... Read more
Moderna COVID-19 Vaccine EUA, after waiting 15 minutes after vaccine, I left and stopped at a restaurant for a plate to go home, went home and began eating, after awhile i became very nauseated and seemed to not taste my food, but that was intermittent. about 2-3 hours later i became very ill with hoarse cough, bad headache, low grade temp of 99.6 ...this continue thru the night, not letting me get much sleep, next day, Thursday, my left arm was so very sore i couldnt lift it, but the pain went across the top of my back to top of my right arm...couldn't raise either arm. Friday continued to feel the same sickness, nauseated, headache, off and on low grade temp and pain in arms and upper back. I was taking 800mg Ibuprofen 3 times a day and it would ease off headache a little, but nothing would stop for long. I was just miserable. had heard the 2nd vaccine could cause such problems, but not the first...therefore, I am a little frightened of getting the 2nd vax. I tried to call the triage nurse at the VA to ask her about it, but never could get thru to her. Sent message saturday night to PCP, and was told to go to this website and put in info.
66 2021-02-01 impaired work ability 1/30/21 booster rec'd approx 8:30am 5p onset body aches, joint and back pain, Chills 9:15p oral tem... Read more
1/30/21 booster rec'd approx 8:30am 5p onset body aches, joint and back pain, Chills 9:15p oral temp 101.7F 10:47p oral temp 102.9F 10:48p took ibuprofen 400mg 11:40p oral temp 102.0F 1/31/21 10:15 am oral temp 100.2F 12:20p oral temp 100.0F 1:50p ibuprofen 600mg 2/1/21 8:45A oral temp 97.9F L lymph nodes sore 8p feeling achy again, took ibup 400mg, 9P oral temp 98.4F, feel like it is climbing too additional 200mg ibuprofen 2/2/21 5:30am oral temp 97.6,F. went to work 6:30a. at 8:30A, light headed, dizzy, unable to stand left work, went home
66 2021-02-01 loss of personal independence in daily activities, hallucination, amnesia, feeling abnormal From my diary about the events of yesterday and today: I will try to relate what happened to me ye... Read more
From my diary about the events of yesterday and today: I will try to relate what happened to me yesterday. I received my second Covid vaccination a few days ago and perhaps the following is related, but I?m not sure. I think I felt fine yesterday morning, and decided to scrub my tub. I was mostly finished when I felt dizzy and went to lie down around 1pm. A friend texted me asking if I was free for a chat, but I wanted to rest a little and did so, texting her when I awoke. I did feel out of sorts when I awoke, and was aware that I had had some dreams, but texted her anyway. We agreed to have a call at 2pm. While on the call, I felt I was struggling with the conversation. I was trying to tell her of my experiences with a recent part-time job (which I quit) and couldn?t remember names of people I worked with or certain events that I wished to convey. I still can?t remember names of people with whom I worked, and it was just one week ago that I left. I suddenly felt really out of it and nauseous, and struggled to tell my friend I needed to get off the phone. I could not remember her name, to tell her this (and I've known her for 40 years)! The next few hours are a total fog. I know I was having dreams of a sort, but I was not asleep. There are maybe 2 hours that I can?t account for. It is most troubling to me that I can?t account for this time, but I know something was happening with my brain and while I was having these dreams or hallucinations, I was not asleep. I remember having to think really hard about what my son-in-law?s name was ? note that I live with this person. I did not seek medical care, but feel like this information could be related to the Covid vaccine, and may be important to you. It was my night to cook, and I had a really hard time keeping up. I did manage to pull most of a meal together, but right before I was done, I needed to call my daughter to finish it. I was unable to eat anything myself, and only wanted a drink. I felt really nauseous and unsteady, although my thinking was a bit more clear by this time. I?m not sure when the numbness in my toes and fingers on one side of my body (right side) started, but as of this afternoon, both are still numb and weak. It is 1:00pm and I am still having trouble remembering some things, and that few hours of the afternoon from yesterday are completely lost to me. I have like a shadow hanging above one eye. I am seriously thinking I have had some sort of a neurological event. As of 3:00 today, my right hand and right foot are still numb, although my thinking seems to be clear.
66 2021-02-02 anxiety PATIENT COMPLAINED OF APPREHENSION WITH VACCINATION. 3:04 BP 160/80, HR 96, RR 16 3:14 BP 140/70, HR... Read more
PATIENT COMPLAINED OF APPREHENSION WITH VACCINATION. 3:04 BP 160/80, HR 96, RR 16 3:14 BP 140/70, HR 68, RR 20 3:33 BP 130/70, HR 80, RR 20 4PM LEFT SITE IN STABLE CONDITION
66 2021-02-03 excessive sleepiness, impaired work ability 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 nervousness 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 loss of personal independence in daily activities, sleep disorder Extreme muscle pain in both upper arms (elbow to shoulder). Contstant throbbing and severe pain in... Read more
Extreme muscle pain in both upper arms (elbow to shoulder). Contstant throbbing and severe pain in moving arm. Started 10+ days after vaccine and still happening. Effects daily activity and sleep. red circle around site that was hot. Lasted 10 days. I felt like I was getting sick the day after the vaccine. Lasted 1 day.
66 2021-02-05 nervousness EXCEPT FOR A SLIGHTLY SORE ARM, I WAS FINE THE REMAINDER OF THE DAY ON 01/11/21 UNTIL AROUND 2 AM ON... Read more
EXCEPT FOR A SLIGHTLY SORE ARM, I WAS FINE THE REMAINDER OF THE DAY ON 01/11/21 UNTIL AROUND 2 AM ON 01/12/21. I WOKE UP WITH NAUSEA AND SEVERE STOMACH CRAMPING (SIMILAR TO SYMPTOMS I EXPERIENCE WITH EPISODES OF DIVERTICULOSIS). I IMMEDIATELY RAN TO THE BATHROOM TO TAKE A HYOSCYAMINE TABLET (0.125 MG) FOR THE PAIN. IT WAS TOO LATE - I HAD TERRIBLE VOMITING AND DIARRHEA/CRAMPING. IT EVENTUALLLY SUBSIDED BUT I HAD A SECOND EPISODE ABOUT 2 HOURS LATER. AT THAT TIME I TOOK AN ANTI-DIARRHEAL PRODUCT WHICH HELPED. I WAS DRAINED (WEAK AND SHAKY) THAT DAY AND INTO 01/13/21 - SLEPT ALOT.. I STARTED FEELING BETTER IN THE AFTERNOON OF 01/13/2021. I DON'T KNOW IF IT WAS A VACCINE REACTION OR A DIVERTICULOSIS EPISODE.
66 2021-02-06 feeling abnormal Felt a little out is sorts but nothing to complain about. Sore arm but again nothing to complain abo... Read more
Felt a little out is sorts but nothing to complain about. Sore arm but again nothing to complain about. Most concerning is the red patch that doubled in size on 2/5/2021. I had been putting various ointments on it not even thinking it was related to the shot. Then I saw an article and knew this looked like my arm.
66 2021-02-07 excessive sleepiness The evening of the day after vaccination my stomach was upset, then had a large amount of green diar... Read more
The evening of the day after vaccination my stomach was upset, then had a large amount of green diarrhea, chills. That night and the next day I slept most of the time and had chills, It's now the 3rd day and I'm feeling a bit better but still very tired and sleeping a lot.
66 2021-02-08 loss of personal independence in daily activities, sleep disorder After a half hour of receiving the vaccine, I experienced redness and swelling in the injection site... Read more
After a half hour of receiving the vaccine, I experienced redness and swelling in the injection site, flushing on my forehead and nose, and itching all over my body. I took a 25mg dose of Benadryl and the hospital monitored my vital signs for about an hour afterwards. I had a fever on the second day (2/06/2021) but it only lasted about 5 hours. However, I have had constant systemic itching everyday. I take 25mg Benadryl but today, 2/09/21, it has been more intense. Please note that I had no reaction to the first dose besides a sore arm for three days. I am very concerned about the itching and it is making it difficulty for me to sleep and also to do my daily activities.
66 2021-02-09 confusional state 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 sensation of foreign body, sleep disorder 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 anxiety Patient felt tingling in her tongue followed by the sensation her throat was swelling and anxiety. S... Read more
Patient felt tingling in her tongue followed by the sensation her throat was swelling and anxiety. Symptoms resolved on their own without intervention within 30 minutes.
66 2021-02-10 disturbance in attention fatigue & soreness at injection site, treated with ibuprofen 1/16/2021. Headache, "hard to concentr... Read more
fatigue & soreness at injection site, treated with ibuprofen 1/16/2021. Headache, "hard to concentrate", productive cough with mild, intermittent SOB began on Thurs 2/4/2021, called PCP and treated with antibiotics. Respiratory symptoms have resolved with use of antibiotics & inhaler, however headche & difficulty with concentration remain. PCP has told her that this is a result of the first vaccine.
66 2021-02-10 feeling abnormal Client recieved vaccine at 2:28pm. Client was waiting post vaccine and stated she felt funny. RN ass... Read more
Client recieved vaccine at 2:28pm. Client was waiting post vaccine and stated she felt funny. RN assessd client. Client co of headache and feeling "foggy". Client was a&o x3 vitals were WNL. 2nd RN called to room. Client stated she felt like her tongue was swelling. RN noted swelling of tongue. 911 called, EMS arrived. Assessed client. Client vitals remained WNL. EMS encouraged client to be evaluated by local hospital. Client refused. Client continued to be observed, client stated she felt like the swelling of her tongue was decreasing. EMS felt client could be released from health dept to home. Encouraged client to take bendadryl and to seek medical attention if condition worsened.
66 2021-02-10 feeling abnormal Same evening when I got the vaccine my arm started hurting from the shoulder to the elbow it was an ... Read more
Same evening when I got the vaccine my arm started hurting from the shoulder to the elbow it was an intense pain I couldn't out my hand up because it will hurt it felt so heavy, I also felt fatigue & my body started hurting. The next day when I woke up I had a headache I felt space out I didn't feel myself I also got diarrhea & the diarrhea lasted until 2/10/2021.
66 2021-02-10 restlessness Fever 99-100 F for 7 days so far. Restlessness, fatigue.
66 2021-02-11 insomnia Initially within a hour slight headache, slight nausea. Lasted 2 days after injection. Two days aft... Read more
Initially within a hour slight headache, slight nausea. Lasted 2 days after injection. Two days after injection, only at night when laying down, severe localized pain near shoulder blade and spine. Deep throbbing and sharp pain. Very difficult to sleep. Lasted 3.5 days, started at night. During day, moving around, working with horses was not noticed. Still have that localized pain going on 7 days. As of 2/12/21. But not to the extent stated earlier. When pain first started, took 800 milligrams ibuprofen each night and 400 milligrams for two nights. Medicine took about 2.5 hours to actually work enough to be able to sleep. Have not taken any meds for 2 nights now. Occasional throbbing but staying away from meds.
66 2021-02-13 sleep disorder, feeling abnormal 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 sleep disorder 56 hrs. after injection starting having pain in left shoulder. Pain became so intense, could not sle... Read more
56 hrs. after injection starting having pain in left shoulder. Pain became so intense, could not sleep, level 8 on 1 to 10. Responds to ice, but any movement of shoulder causes acute pain.
66 2021-02-13 thinking abnormal 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 2021-02-14 feeling abnormal I was fine all day working from home and it was the end of the day at 5:12 PM and was walking to th... Read more
I was fine all day working from home and it was the end of the day at 5:12 PM and was walking to the bathroom in my home and all of a certain I started shivering and was extremely cold. I could barely use the bathroom, but did and felt bad so I hurried and put on my pajamas and went to the family room and sat down my whole body shaking /shivering and I was freezing. I covered up with a blanket and shook profusely for about 25 minutes. I checked my temperature and it was 97.5 and then a few minutes later it was 97.7. The severe shivering and cold ceased and was kind of intermittent but not too bad. I was very tired and slept in my chair on and off until about 10:00 PM and then I went to bed and I had a headache. I also was a little warm after the shivering stopped. My temperature before bed was 98.2. The next morning had a mild headache most of the day, I took a Tylenol and didn't feel real good until about 3:00 PM, but I was fully functioning .
66 2021-02-14 feeling abnormal Fatigue, chills and pain all over my body. Not sure about fever as I didn't have a thermometer. The... Read more
Fatigue, chills and pain all over my body. Not sure about fever as I didn't have a thermometer. The symptoms got better yesterday but deteriorated again Sunday night. It is now Monday morning, 9;48 pm est. and I am still feeling bad and having the symptoms stated above. I have been drinking orange juice and water and taking Tylenol and nyquil. I am concerned about how long the symptoms are continuing and if I should be doing something different.
66 2021-02-14 sleep disorder Severe chills, unable to walk, unable to sleep, severe leg aches, severe backaches, unable to eat, s... Read more
Severe chills, unable to walk, unable to sleep, severe leg aches, severe backaches, unable to eat, symptoms lasted 32 hours. Fatigue continues. Husband had absolutely no symptoms.
66 2021-02-15 depression, anger Exhaustion, depression, loss of appetite, soreness and tightening of throat on the third day after i... Read more
Exhaustion, depression, loss of appetite, soreness and tightening of throat on the third day after injection. Severe moodiness, short temper, loss of interest in everything. When lying down to sleep a strong, tingling , electrifying sensation that started at my left foot moving up to my groin area.
66 2021-02-15 sensation of foreign body Felt "bubble" in throat, sudden onset. mucus sensation in throat. 1600. Patient returned to stadium ... Read more
Felt "bubble" in throat, sudden onset. mucus sensation in throat. 1600. Patient returned to stadium . Patient left with her daughter after wating 15 minutes in observation after her injection. returned at 4pm complaining of "bubble " in throat. BP 184/149 HR92 o2 sat 95% 1601 blood pressure 177/94 1605 BP 176/103 HR93 o2 96% 1609 BP 176/98 HR 96 o2 94%, 911 called for EMS 1611 EMS arrived, patient care transferred to EMS, patient continues to complain of "bubble sensation". Transferred to Hospital
66 2021-02-15 sensation of foreign body Feeling of elevated temperature, rash, light headness, nausea, feeling of lump in the throat.
66 2021-02-16 memory impairment Had to be observed for 30 minutes following the vaccine due to her allergies. She had the expected ... Read more
Had to be observed for 30 minutes following the vaccine due to her allergies. She had the expected arm tenderness, but 10 hours later she started experiencing severe pain to the point that she could hardly walk. The pain was in her legs, thighs, hips, shoulders, ankles, it was pretty bad. She also had a sense of malaise, and tiredness. She was frightened due to the pain. She was also having memory issues, could not remember things within 10 minutes. She went to bed and got up the next morning with the same pain and could not sleep due to that pain. Nine days after the vaccine she is still experiencing the pain, but the fatigue and memory issues were still present. She called the Covid 19 hotline who transferred her to a pharmacist, who told her that the reaction. He advised her to get blood work to get RA factors checked, and they were very very low and did not trigger that, but still experiencing the pain. it is less than it was, but still experiencing the pain. She is still also experiencing itching from the injection site. Has not slept due to the pain, and scared to get the 2nd vaccine.
66 2021-02-16 nervousness, feeling abnormal Client reported that her face felt like it was burning and she felt "odd". Client wanted to sit out... Read more
Client reported that her face felt like it was burning and she felt "odd". Client wanted to sit outside to get fresh air. Client stated that she was very nervous about getting the vaccine. After sitting outside x 15 minutes, client felt much better and wanted to leave. Client called on 2/11/2021 to report redness and warmth to injection site. Client could also feel a lump that was slightly smaller than the palm of her hand. Recommended client follow up with her PCP.
66 2021-02-17 loss of personal independence in daily activities 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 2021-02-18 confusional state 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 sleep disorder She states she woke at 02:00am with her palms of her hands, bottom of her feet, and toes all itching... Read more
She states she woke at 02:00am with her palms of her hands, bottom of her feet, and toes all itching and burning, like they were on fire. She took 2 Benadryl. It eased up and she back to sleep. She woke about 8:00am with rash on her arm around her wrist area that was itching and had welts. This rash progressed up the inside of her arm, to her back, and on both insides of her legs down to her ankles. Her lips swelled, but not her tongue. She was treated at Emergency Room with Steroids and more Benadryl and given Rx for Steroids. She states she also developed a blister on her top lip and inside her right nostril both of those lasted about 4 weeks. Her rash resolved after taking the Steroids for 5 days. She states every now and then she still has some tingling in her finger tips. She follow up with her Primary Care Provider's office and told not to get the 2nd dose of the vaccine.
66 2021-02-19 sleep disorder Arm had been itching since the vaccination, but last last night the itching was so bad it woke me up... Read more
Arm had been itching since the vaccination, but last last night the itching was so bad it woke me up. When I looked at it it was very red and swollen, about 2 1/2" round, very hard, and hot to the touch. It appears to be lower than the injection site, but I can't be sure. I put cortisone cream on which helped a little. I don't feel it's necessary to go to a doctor, as I'm hoping it just goes away in a few days.
66 2021-02-21 fear When I first got the vaccine I was fine but as the day went on I felt soreness in my left arm with s... Read more
When I first got the vaccine I was fine but as the day went on I felt soreness in my left arm with some stiffness in my neck. Later on in the afternoon, I started getting a headache, neck was getting stiffer and my back started to hurt. When I got home around 5 I fixed some dinner, within 30 minutes or less it felt like my stomach exploded, I was throwing up continuously, it was so intense, I tried sips of water to throwing it up as well. I could feel my esophagus burning up to my throat, and starting to feel like it was closing up. All during this time my eyes hurting and light really bothered me. I was to afraid to lay down, I got myself to calm down, and doing deep breathing. That seemed to help me. I was scared. I stayed home through the night and woke up the next day feeling better. I still have headaches to this day.
66 2021-02-21 nightmare Exhaustion, headache, loss of appetite, nightmares, chills and fevers, profuse sweating, diarrhea, b... Read more
Exhaustion, headache, loss of appetite, nightmares, chills and fevers, profuse sweating, diarrhea, body aches.
66 2021-02-23 sleep disorder Raised red circular rash that is extremely itchy and sore and is 2" by 3" in size. Started after inj... Read more
Raised red circular rash that is extremely itchy and sore and is 2" by 3" in size. Started after injection about 2 hours later, got itchy and sore for 4-5 days. Started to get better and then got worse on 7th day post injection. Being treated with Benadryl tablets by mouth and ice packs. Severe enough to wake me from sleep and keep me awake.
66 2021-02-24 anxiety Patient endorses a feeling of numbness in her throat, swelling of the tongue, and tingling of the li... Read more
Patient endorses a feeling of numbness in her throat, swelling of the tongue, and tingling of the lips. It was apparent she was also experiencing increased anxiety with evidence by arm tremors. Patient received 50mg IM diphenhydramine and 4mg of IM Dexamethasone.
66 2021-02-25 feeling abnormal, poor quality sleep At 9pm went to bed early. Just felt crummy. Slept poorly. Temperature at 3:30 am on 2/25/2021 was 10... Read more
At 9pm went to bed early. Just felt crummy. Slept poorly. Temperature at 3:30 am on 2/25/2021 was 101.4. F. Took one 500mg Tylenol. Slept better. Fatigue all day. By 2/26/2021 I?m feeling back to normal.
66 2021-02-25 insomnia 12 hours after vax till now (27 hours). Crushing body pain, fevers up to 101.6, severe headache, chi... Read more
12 hours after vax till now (27 hours). Crushing body pain, fevers up to 101.6, severe headache, chills, nausea and insomnia
66 2021-02-25 sensation of foreign body ~ 30 minutes after the injection I developed in my lower left throat a painful hard lump.
66 2021-02-27 feeling abnormal Besides a slightly sore of arm and slightly elevated but normal temp, I had what I would call brain... Read more
Besides a slightly sore of arm and slightly elevated but normal temp, I had what I would call brain fog for about 4 hours on day 2. I took 2 tylenol and took a 3 hour nap. When I woke I had several questions about events of the day that I did not recall. Plus my daughter was with me and kept asking me if I was ok during prior to nap time.
66 2021-02-27 sleep disorder evening of 2/25 started to have some chills but no chills when I woke up the next day. on 2/26 in t... Read more
evening of 2/25 started to have some chills but no chills when I woke up the next day. on 2/26 in the evening there was an increase in joint pain. I took 400mg ibuprofen at bed time. During the night I woke up due to the pain and noticed that I had been sweating. I took 400mg around 3am and went back to sleep. Woke at 6AM on the2/27and still had joint pain but not as painful as the night before. Couple hours later while taking a shower I noticed that my left arm at the site of the vaccine had a large red blotch. It did not itch or was painful but it was somewhat warm. At that point I called my primary drs office and was advised to go to urgent care. At Urgent care my arm was examined by a doctor and he ordered a Covid test and prescribed doxycycline as he felt I had cellulitis.
66 2021-02-28 feeling abnormal One hour after I received the vaccine, I ate cookies bought in the bakery with birthday cake icing. ... Read more
One hour after I received the vaccine, I ate cookies bought in the bakery with birthday cake icing. Immediately after ingesting the cookies, I developed irritated throat, felt as if my throat was burning, developed coughing, throat felt funny. This lasted for the entire day. Throat looked inflamed for 2 days. This was after my first dose, so I am praying it was a reaction to the cookies and not the vaccine.
66 2021-02-28 mental impairment Upon awakening morning after receiving 2nd dose of Moderna COVID-19 Vaccine EUA: pain & tenderness a... Read more
Upon awakening morning after receiving 2nd dose of Moderna COVID-19 Vaccine EUA: pain & tenderness at injection site, fever of 101.5 F. , extreme fatigue, headache, muscle pain and stiffness all over body, chills, woozy, can't think. Next day: slight fever, all symptoms 50% better. Today: fever gone, all symptoms 90 % better.
66 2021-03-01 anxiety, feeling abnormal 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 disorientation, anger, insomnia, confusional state 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 2021-03-01 excessive sleepiness At approximately 1 hr and 40 minutes after my injection, I had a chill, which almost immediately tur... Read more
At approximately 1 hr and 40 minutes after my injection, I had a chill, which almost immediately turned into total body shaking, rigors. The shaking was so severe that I was having trouble breathing between the shakes. I also had 1 emesis. At approximately 20 minutes of shaking, I called 911 at the advice of a nurseline. EMTs checked my vitals and my BP, pulse, O2 sat and blood sugar was all normal. I almost had another emesis. They offered to take me to an ER, but I declined as I couldn't see what could be done for me at that point. At about 40 minutes of symptoms they began to abate. I then slept for 11 hours straight.
66 2021-03-02 anxiety 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 2021-03-02 confusional state Bad, strong chemical taste in mouth from approximately 10 minutes after vaccination for about 6 days... Read more
Bad, strong chemical taste in mouth from approximately 10 minutes after vaccination for about 6 days after. Slight confusion from about 15 minutes after vaccination, lasting about 15 minutes. Second morning after vaccination woke up seeing a greenish tint to my vision. That cleared in about 5 minutes after drinking a cup of water. Besides these more unusual reactions, my vaccinated arm was sore for several days and I had a runny nose for about 30 -60 minutes on the 4th day afterward and some queasiness and upset stomach also for a day on the 4th day with some fatigue.
66 2021-03-02 insomnia vaccine administration was perfect. About 1700 a severe pain started in the left mastiod bone. I tr... Read more
vaccine administration was perfect. About 1700 a severe pain started in the left mastiod bone. I tried Excedrin Migraine and massage, I applied cold and hot compresses to no avail, pain fluctuated, tried to sleep, pain became worse and more consistent; pain became less frequent Saturday and Sunday morning there was a noticiable difference in the sides of my face. Monday my eye wouldnt close properly and the left side of my mouth would not open so I went to the Urgent Care for treatment
66 2021-03-02 mental status changes, fear, crying, confusional state, amnesia, abnormal behaviour Had episode on 2/24/21 of altered mental state, was w husband and he noted this.Said bizarre things... Read more
Had episode on 2/24/21 of altered mental state, was w husband and he noted this.Said bizarre things. Has no memory of this, lapsed recall for about 8 minutes. Has never had a similar episode. No hx of psychosis, bipolar or major mental illness of any kind, When returned to alert/aware mental state, was terrified and crying. No stressors, says has stable life, no violence or threats. Seen in ER 2/24/21, but no brain imaging or EEG. Clarifies that dizziness and HA went on for several days, beginning same day 2/19 after got 2nd dose Covid vaccine, but the confusion/altered mental state was only for about 8 minutes. on 2/24. Still dizzy/HA/fatigue and some SOB as of 3/2/21. No fall or head trauma.
66 2021-03-03 disorientation The very next day after the vaccine, in the evening I started feeling feverish and the next day I go... Read more
The very next day after the vaccine, in the evening I started feeling feverish and the next day I got chills, fever and that is pretty much it. I was ok the next morning, I thought I was going to be alright, then Saturday my temperature went up to 104.6 and I could not get it to go down. was taking Tylenol every 4 hours and it would not go down. I was shaking so bad. I was trying to do my chores and I could not physically do anything. I could hardly walk, I could not even go get some water. I felt disoriented. It was my own house that I lived for 24 years and I felt disoriented. I could not remember where the kitchen was. It lasted until about 8PM Sunday evening. Then I started feeling like a human again. I was able to walk to the bathroom by myself. My husband made me a bowl of soup that was the first time I ate since Friday. By that time I was coherent, was able to take a shower and around 10PM I went to bed and slept until 8AM Monday morning, I woke up like nothing had happened.
66 2021-03-04 excessive sleepiness 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 2021-03-05 emotional distress Pt complained of facial flushing and feeling warm all over. RN had pt seen by EMT on site. Pt is Pre... Read more
Pt complained of facial flushing and feeling warm all over. RN had pt seen by EMT on site. Pt is Pre-diabetic and on Metformin, FSBS-183. Pt stated that is very elevated for her. EMT gave pt information on how to aquire glucometer to do testing at home. Pt also stated she recently experienced a house fire and is under a lot of stress. EMT had pt stay for an extra 10 min and then relesed her to go home. - RN
66 2021-03-06 insomnia Severe chills, extreme sweating, nausea, vomiting, weakness, fatigue, loss of sleep, body aches, hea... Read more
Severe chills, extreme sweating, nausea, vomiting, weakness, fatigue, loss of sleep, body aches, headache off and on for 17 consecutive hours. Side effects began to subside around 3 PM 02/28/2021. Some swelling of mouth and tongue and general fatigue continued until 03/05/2021, then gradually went away.
66 2021-03-07 feeling abnormal Arm sore from 1:00pm on 2/27 until 8:00 on 3/2. Chills off and on from 12:10am - 8:00am on 2/28. On ... Read more
Arm sore from 1:00pm on 2/27 until 8:00 on 3/2. Chills off and on from 12:10am - 8:00am on 2/28. On 2/28 felt tired and just lousy. No fever, not achy, no nausea or vomiting. Felt 100% better by 8-00pm same day.
66 2021-03-07 impaired work ability, memory impairment Severe headache with nausea. Cognitive impairment (forgetting important meetings with clients, unab... Read more
Severe headache with nausea. Cognitive impairment (forgetting important meetings with clients, unable to complete documents pertaining to work.) Continuing at this time of making the report.
66 2021-03-07 insomnia, restlessness I felt sick (upset stomach) immediately after injection. I went home and slept for 2 hours, got up a... Read more
I felt sick (upset stomach) immediately after injection. I went home and slept for 2 hours, got up and felt under the weather the rest of the day, a lot of pain at injection site. Got up Sunday morning still feeling under the weather. Took a nap at 1 pm and woke up at 5:30 pm with fever of 101.5, shortness of breath, headache and chills. Drank some water, went back to bed with extra covers. Got up at 7 pm and took 2 ibuprofen as headache was unbearable. Fever was now 99.5 and I was sweating profusely from the fever and was restless, could not sleep. Finally slept at 1 am. Still have headache today. I WILL NOT BE GETTING THE 2ND DOSE.
66 2021-03-07 insomnia 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 2021-03-07 sleep disorder, feeling abnormal Felt fine (with some muscle ache in my arm ) until approx 6:00 p.m when a migraine headache starte... Read more
Felt fine (with some muscle ache in my arm ) until approx 6:00 p.m when a migraine headache started. I did not take any medication because I didn't want to undermine the success of the vaccine. I also experienced severe chills but at the same time my body felt hot. As the eve wore on I had a bad stiff neck. I went to bed with an ice pack & did not sleep much. I still had the same symptoms the next day until I finally took 1 Motrin at 2:00 p.m. & another approx 1 hr. later. Then the symptoms began to lessen. Did not sleep well Sat eve either - my legs just felt weird. Finally I felt better around 9:00 a.m. on Sunday but still somewhat dizzy when moving too quickly.
66 2021-03-07 sleep disorder I was given my first Moderna vaccination at Pharmacy on February 26, 2021. I noticed at the time th... Read more
I was given my first Moderna vaccination at Pharmacy on February 26, 2021. I noticed at the time that the needle was open and not covered but didn't think anything about it. Later that evening my arm was sore. Knew that was to be expected. Within 2 days my upper arm was beet red and swollen beyond recognition. Finally after 10 days of pain I went to Urgent Care in and saw a doctor there. My arm was indeed infected. Doctor gave me prescription for Amoxicillin & Clavulanate Potassium 875 mg. Take one twice a day. Was also given Triamcinolone Acetonide Ointment USP 0.1% to put thin layer on arm twice a day. Today is Monday March 8th and the redness, swelling and infection has moved down to my elbow and as far as pain is concerned it's a 5 out of 10. It's starting to affect my fingers too. Elbow area is now red and very swollen and HOT! I'm going to try to get into my regular doctor today to see if she can help me. I can't sleep it hurts so bad.
66 2021-03-08 feeling abnormal headache, vomiting, brain fog, emotional, heart issues
66 2021-03-08 excessive sleepiness Right arm pain , hot to touch, pain in joints a d muscles like flu, fever of 100.0, fatiqued, sleep ... Read more
Right arm pain , hot to touch, pain in joints a d muscles like flu, fever of 100.0, fatiqued, sleep a lot.
66 2021-03-08 insomnia Had significant tooth pain about 14 hours after vaccine. Toothache coincided with sleeplessness, in... Read more
Had significant tooth pain about 14 hours after vaccine. Toothache coincided with sleeplessness, injection site pain and headache. All symptoms but toothache cleared within 2 days, continued taking Advil for tooth pain and salt water rinse. Already had dental referral to evaluate ongoing sensitivity to hot/cold but sensitivity turned into constant ache. Have dental on Thursday, March 11. May simply be coincidence but today - four days following vaccine - tooth pain is much decreased.
66 2021-03-10 feeling abnormal 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 excessive sleepiness Moderna Covid-19 EUA Later the second night - I had very sharp pain in my left breast and upper ba... Read more
Moderna Covid-19 EUA Later the second night - I had very sharp pain in my left breast and upper back for 2 days, excessive sleeping, no energy.
66 2021-03-11 feeling abnormal 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 2021-03-12 confusional state 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 feeling abnormal General severe arthralgia, severe muscle pain all over, slight mental fogginess, headache, chills, b... Read more
General severe arthralgia, severe muscle pain all over, slight mental fogginess, headache, chills, blotchy red circular rash on right arm 2 days after vaccine, swelling and pain at injection site.
66 2021-03-12 feeling abnormal at 4:15 pm my body started shaking. I was extremely cold. Headache, Tylenol wasn't able to take care... Read more
at 4:15 pm my body started shaking. I was extremely cold. Headache, Tylenol wasn't able to take care of it. Body hurt all over. Very nauseous and threw up. Had Thrush in my mouth. It has been 3 days and still not feeling very good
66 2021-03-12 loss of personal independence in daily activities every cell in my body ached, fever, dizziness, extreme pressure headaches, couldn't move/walk much, ... Read more
every cell in my body ached, fever, dizziness, extreme pressure headaches, couldn't move/walk much, shivered in bed night of injection, couldn't eat, tried to drink, nausea, blurred vision, extreme fatigue, couldn't stand loud noises/tv, couldn't read, felt like every cell in my body was fighting to live. Aleve helped the second nigh but not the first.
66 2021-03-14 insomnia Horrendous headache Tooth pain Neck pain Joint pain Chills Nausea Insomnia
66 2021-03-14 loss of personal independence in daily activities 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 sleep disorder, nervousness 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 2021-03-15 disorientation 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 disturbance in attention, feeling abnormal, impaired work ability Symptoms began as expected on the day after the 2nd vaccine, but never went away. The fever (102 deg... Read more
Symptoms began as expected on the day after the 2nd vaccine, but never went away. The fever (102 degress) subsided, but a continuous headache, varying degrees of dizziness and brain fog (the inability to focus or concentrate) continue uninterrupted. It has now been two weeks since my 2nd vaccination and it is difficult for me to attend meetings or focus and follow up on projects. I continue to experience fatigue, dizziness, pain and stiffness in my neck where it attaches to my head - and low-grade headache. I have NO prescription medications and NO pre-existing conditions. I am taking aspirin or Tylenol or Advil to see if any of them are effective. The neck pain is helped by the over-the-counter pain relievers, but the brain fog and dizziness continue along with a dull headache.
66 2021-03-15 feeling abnormal a few days after the shot I started feeling crappy. I have muscle pain, joint pain, chills, dizzines... Read more
a few days after the shot I started feeling crappy. I have muscle pain, joint pain, chills, dizziness and weakness.
66 2021-03-15 insomnia, feeling abnormal 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 2021-03-17 insomnia 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 2021-03-18 agitation Agitation, Rash, fatigue Narrative:
66 2021-03-18 feeling abnormal Nausea, Dizziness, Tinnitus, brain fog All still ongoing
66 2021-03-18 impaired work ability 11 days after shot my arm (Injection site) swelled to size of goose egg. Became very painful, red. W... Read more
11 days after shot my arm (Injection site) swelled to size of goose egg. Became very painful, red. Went to doctor on 3/17. Dr said it was likely an infection at the injection site. Perscripted cephalexin for 5 days. Day 3 and not much improvement. Had to take off work. Was told to finish antibiotics and see if its better by monday.
66 2021-03-18 impaired work ability Fever from 100.3 to 101.0 Fahrenheit, terrible headache that would not stop for 3 days, terrible joi... Read more
Fever from 100.3 to 101.0 Fahrenheit, terrible headache that would not stop for 3 days, terrible joint pain and body aches, diarrhea Symptoms lasted from March 14-March 18, 2021. Missed 3 days of work due to illness.
66 2021-03-18 sleep disorder Body aches, headache, nausea, unable to sleep
66 2021-03-19 disturbance in attention, sleep disorder 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 2021-03-20 feeling abnormal, depression, depressed mood, sleep disorder 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 2021-03-22 disturbance in attention, feeling abnormal Began after the vaccine + 6 hrs after receiving the vaccine - Began to feel tired and achy about 6 h... Read more
Began after the vaccine + 6 hrs after receiving the vaccine - Began to feel tired and achy about 6 hours after receiving the vaccine + 8 hrs - Fever of 101.3 for roughly 24 hrs with Aches and Chills Itchy rash by the vaccine location - roughly 4 by 6 inches, lasted 5-6 days + 36 hrs - Brain fog noticed - lasted through day 6 after getting vaccinated unable to focus or concentrate and forgetful through day 8 after the vaccine - weary and slept more than usual (10 hrs vs 7 or 8/day)
66 2021-03-22 restlessness 3/18/2021 12:00 PM- numbness in lower part of left arm from armpit to little finger, ended at approx... Read more
3/18/2021 12:00 PM- numbness in lower part of left arm from armpit to little finger, ended at approximately 2:00 PM 11:00PM-severe chills, severe pain in shot location, body muscle aches followed by nausea- took 1 Advil, chills went away 2:00 AM -severe chills, body aches, followed by nausea-took 1 Advil, chills went away, able to sleep 5:00AM - nausea, body tried to vomit but nothing in my stomach so had dry heaves, lasting for about 30 minutes and profuse sweating body felt hot, nausea, and body aches continued for about 1/2 the day. I took an Advil sinus and cold caplet that made me feel better. 5:00PM began feeling sick once again, body aches, chills, sweating. took temperature 100.5. (didn't take temperature before because too sick to look for thermometer. Tried to sleep but too restless. Took 2 Advil, fever went away as well as body aches and nausea. slept through the night. 3/19/2021 Woke up approximately 6:00AM, left arm hurt about an 8 out of 10, very sore to move and swollen. I felt very tired and lethargic.
66 2021-03-22 sleep disorder Waking up in the middle of the night, (3:00 or 4:00am) by very sore left arm, almost like a cramp, m... Read more
Waking up in the middle of the night, (3:00 or 4:00am) by very sore left arm, almost like a cramp, most prominently around muscles of injection site and then down my arm. This has occurred each night beginning 2 DAYS AFTER the injection. Except for local burn or swelling the first day, the adverse reaction did not begin until 2 days later. I moan in my sleep because of the pain, awaken and jump out of bed, flinging my arm around, grabbing it, massaging it, desperately trying to relieve the pain then take 2 500mg acetaminophen which helps it subside quickly and enables me to go back to sleep.
66 2021-03-23 confusional state, hallucination Arm so painful; Hallucinating; Shaking and shivering; Fatigue; Headache; Muscle aches; Fever; Threw ... Read more
Arm so painful; Hallucinating; Shaking and shivering; Fatigue; Headache; Muscle aches; Fever; Threw up x1; Didn't know who I was; I couldnt lift my arm; Getting weak; Arm got severely swollen; 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 hallucinating (hallucination), didn't know who I was (confusional state), couldn't lift arm (muscular weakness), got weak (asthenia), arm got severely swollen (peripheral swelling), pain (pain in extremity), fever (pyrexia), headache, fatigue, threw up (vomiting), shaking and shivering (chills) and muscle aches (myalgia). The patient's medical history and concomitant products used were unknown. On 03-MAR-2021, approximately 12 hours prior to onset of first event, the patient received their first planned dose of mRNA-1273 (Lot/Batch number: 022M28A) intramuscularly for prophylaxis of COVID-19 infection. Within the first 12 hours of being vaccinated, the patient experienced minor arm soreness, which ended the same day. The next day, she experienced fatigue, headache, shaking and shivering, muscle aches, was getting weak, threwup once, fever, and didn't know who she was. She lived alone and was hollering for someone to help her. She couldn't get out of bed. She was hallucinating; she thought the floor was wet. Her arm was severely swollen and painful. The patient couldn't lift her arm. Treatments of these events were not provided. Action taken with mRNA-1273 in response to the event is unknown. The outcome for the events, hallucinations, confusional state, muscular weakness, asthenia, peripheral swelling, pain, fever, headache, fatigue, vomiting, shaking/shivering and muscle aches, 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, confusional state, muscular weakness, asthenia, peripheral swelling, pain, fever, headache, fatigue, vomiting, shaking/shivering and muscle aches, a causal relationship cannot be excluded. Very limited information regarding the hallucinations has been provided at this time. Further information has been requested.
66 2021-03-24 feeling abnormal, disturbance in attention 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 2021-03-24 feeling abnormal 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 loss of personal independence in daily activities In addition to the expected chills, arm pain, achiness, & fever of 101, I experienced such severe n... Read more
In addition to the expected chills, arm pain, achiness, & fever of 101, I experienced such severe nausea that I was unable to even sip water. I also experienced the worst migraine pain of my life, even though I have had chronic migraine for 50+ years, & was so nauseous that I was unable to take my migraine medication. I was unable to get out of bed & lift my head off the pillow. I also experienced 2 hours of severe foot cramps in both feet, which I have never had before. I am 66, live alone, & if I had not been too ill to move my head, I would have gone to the hospital for intravenous medication. The illness lasted from 11 pm till 4pm the next day. I worked as a medical assistant for 32 years & I would not describe this as simply side effects of a vaccine, but felt seriously ill.
66 2021-03-25 memory impairment 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 2021-03-27 feeling abnormal Dizziness ,headaches migraines, neck pain, shoulder pain,brain fog ,nausea
66 2021-03-28 restlessness 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 feeling abnormal, excessive sleepiness Received 2nd dose at 10:56 AM on Saturday, March 27, 2021. At around 9:00 PM that evening started ... Read more
Received 2nd dose at 10:56 AM on Saturday, March 27, 2021. At around 9:00 PM that evening started to feel odd. That entire night had fever, chills, headache and body ache. Highest temperature was 102. Did take Tylenol and Ibuprofen intermittently. Slept most of Sunday and half of Monday, March 29th. Temperature finally returned to normal at around 4:30 PM on Monday, March 29th. I had NO adverse reaction to Dose Number one on February 27, 2021.
66 2021-03-29 feeling abnormal Event after second Covid vaccine: mild and periodic headache for first few days. On day 5, dizziness... Read more
Event after second Covid vaccine: mild and periodic headache for first few days. On day 5, dizziness and increased tinnitus. On days 6 and 7, fatigue, dizziness, brain fog, headache and worsening tinnitus.
66 2021-03-29 feeling abnormal Thirty minutes after the injection while driving home, my left eye got this weird sensation, maybe l... Read more
Thirty minutes after the injection while driving home, my left eye got this weird sensation, maybe light pins and needles, it's hard to describe. Just the skin, not the eyeball. Lasted about 15 seconds. Two hours later my right ear started itching along with the right side of my throat. Lasted 30 minutes. The itching was mild compared to my old food allergies and penicillin reactions. No need for a Benadryl.
66 2021-03-29 insomnia fever as high as 104 with chills, sweats, aches, bad headache, sleeplessness for 36 hours, Next 36 ... Read more
fever as high as 104 with chills, sweats, aches, bad headache, sleeplessness for 36 hours, Next 36 hrs: hot/cold sweats, headache, vertigo. Nasty rash on arm of injection sight.
66 2021-03-29 insomnia Temp of 101.9 (normal for me is 97.6), crushing headache, severe body aches making it extremely diff... Read more
Temp of 101.9 (normal for me is 97.6), crushing headache, severe body aches making it extremely difficult to even get to bathroom, exhaustion but inability to sleep secondary to pain, very painful left arm making it difficult to move arm, loss of appetite, extreme malaise. Symptoms lasted about 48 hours and have been abating - as of 3/30/21 remaining symptom is exhaustion and intermittent mild headache and general malaise.
66 2021-03-30 insomnia Initial response was fever 100.3, headache, loss of appetite, sleeplessness. These resolved after a ... Read more
Initial response was fever 100.3, headache, loss of appetite, sleeplessness. These resolved after a day but oral lesions erupted by the 2nd and though improving slowly, still have not subsided.
66 2021-03-30 sleep disorder 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 sleep disorder Pt claimed sx noticed when she woke up at 2am. Complained of throat closing up, difficulty breathin... Read more
Pt claimed sx noticed when she woke up at 2am. Complained of throat closing up, difficulty breathing, gi discomfort, and face swelling
66 2021-03-31 feeling abnormal Pain in arm first few days. Then resolved. On day 8, I developed a general feeling of malaise, tir... Read more
Pain in arm first few days. Then resolved. On day 8, I developed a general feeling of malaise, tiredness, achy muscles and slight headache. These feelings continued into day 9. I rested and took aspirin. Then, on day 10, I felt better but noticed I had developed a red, slightly raised rash at the injection site. About 2 inches in diameter. It is still there. I also noticed that at about the same time as I started feeling bad, my resting heart rate (which I continuously monitor on my Fitbit) had jumped from the 59-62 range, to 66-68 range. The heart rate is still up although I feel ok otherwise.
66 2021-03-31 mental status changes 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 delirium, abnormal behaviour Unsteady/had to hold onto the wall to keep upright; Forever to write a simple email/weired things; N... Read more
Unsteady/had to hold onto the wall to keep upright; Forever to write a simple email/weired things; No appetite but able to eat after 10 pm; Slept and woke up delirious; Woke up with 101.6 degrees fever; Tremendous itching; Soreness/pain; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Slept and woke up delirious) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 016M20A) 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-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness/pain) and SWELLING (Swelling). On 25-Jan-2021, the patient experienced PRURITUS (Tremendous itching). On 19-Feb-2021, the patient experienced DELIRIUM (Slept and woke up delirious) (seriousness criterion medically significant), GAIT DISTURBANCE (Unsteady/had to hold onto the wall to keep upright), ABNORMAL BEHAVIOUR (Forever to write a simple email/weired things), DECREASED APPETITE (No appetite but able to eat after 10 pm) and PYREXIA (Woke up with 101.6 degrees fever). On 19-Feb-2021, DELIRIUM (Slept and woke up delirious), GAIT DISTURBANCE (Unsteady/had to hold onto the wall to keep upright), ABNORMAL BEHAVIOUR (Forever to write a simple email/weired things), DECREASED APPETITE (No appetite but able to eat after 10 pm) and PYREXIA (Woke up with 101.6 degrees fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Soreness/pain) and SWELLING (Swelling) outcome was unknown and PRURITUS (Tremendous itching) was resolving. No relevant concomitant medications were reported. Treatment for events included 3 paracetamol.; Reporter's Comments: This case concerns a 66 Y/O F with a serious unexpected event of delirium, and nonserious unexpected abnormal behavior, pain in extremity, pruritus, and expected swelling and pyrexia. Serious event onset was 2 days after second dose mRNA-1273. Delirium 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.
66 2021-04-01 feeling abnormal Same evening started freezing cold. tired. went to bed to try to get warm. Woke 3 a.m. so dizzy I h... Read more
Same evening started freezing cold. tired. went to bed to try to get warm. Woke 3 a.m. so dizzy I had to hold furniture to get to bathroom, Headache, achy, feverish but too unsteady to take temp or aspirin. Woke after daylight to 101 fever, usually 97. headache, took aspirin. Mild upset stomach. achy. mildly dizzy. Not clear-headed; filling out this report was too much. By Sunday fever almost gone. A blister inside top lip. Sunday evening well enough to dress & discovered arm sore, red, hot & swollen. I removed bandaid, and it got better over the next few days. Headache continued a few more days but not as bad. I was still very tired; slept most of Friday, Sat & Sunday. That improved but was still unusually tired for a while.
66 2021-04-01 feeling abnormal Intense muscle aches, fatigue, injection site pain, headache, brain fog, low grade fever.
66 2021-04-01 loss of personal independence in daily activities, feeling abnormal 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 sleep disorder Felt extremely fatigue, discomfort, fever, nauseous, unable to sleep but no energy to stay awake and... Read more
Felt extremely fatigue, discomfort, fever, nauseous, unable to sleep but no energy to stay awake and sit up for first twenty-four hours. It felt like my whole body had been turned inside out. The second day was similar but half strength. By the third day I was doing ok except for the lack of sleep from the previous two days. Interestingly, my left arm tingled from the injection site down through my hand immediately after receiving the vaccine and that continued throughout the first day.
66 2021-04-03 feeling abnormal, sleep disorder, insomnia 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 sleep disorder 7 hours after the vaccination, muscle aches, chills and fever started. By 10 hours, the fever was 1... Read more
7 hours after the vaccination, muscle aches, chills and fever started. By 10 hours, the fever was 102+ and stayed high for the next 10 hours. The muscle aches, chills and fever made it almost impossible to sleep. Also my sinuses ached. I was extremely uncomfortable. The next day the fever reduced to 100 - 101 but the other symptoms persisted, and I could barely stomach food or water. This went on for another 12 hours. On the third day I was able to get out of bed but was very weak. I will not take Moderna vaccines in the future.
66 2021-04-06 feeling abnormal pt reports an uncomfortable coin-shaped rash developing on face, first along left jaw, and then new... Read more
pt reports an uncomfortable coin-shaped rash developing on face, first along left jaw, and then new lesions appearing on her forehead and scalp. Areas became increasingly irritated, blistered and then became raw and open over 1 week period of time before clearing. Rash recurred along neck, chest wall and torso, following the same pattern with blistering followed by healing. Patient now reports rash on bilateral knees. Using cortisone to treat. No fevers, no mucosal lesions of oral or eye areas. +brain fog, malaise and fatigue
66 2021-04-06 feeling abnormal 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 disorientation, thinking abnormal, confusional state For about 15 minutes, I could not think or compose a sentence. It did not hurt. I was just confuse... Read more
For about 15 minutes, I could not think or compose a sentence. It did not hurt. I was just confused and disorientated while a friend stayed on the phone with me until it passed. This happened shortly after my vaccine, and it was frightening. Never had this experience before.
66 2021-04-07 insomnia The day after he received the vaccine he began to feel weak, with a headache, insomnia. His legs hur... Read more
The day after he received the vaccine he began to feel weak, with a headache, insomnia. His legs hurt a lot as if they were burning. Very tired and dizzy. When standing, he has no strength in his legs and can barely eat because his mouth feels very dry.
66 2021-04-07 sleep disorder Two hours after the injection, I have a very bad headache. Two Advil cut it within 2 hours. My arm h... Read more
Two hours after the injection, I have a very bad headache. Two Advil cut it within 2 hours. My arm has been sore for the last 9 days, and I cannot sleep on my left side due to soreness. The injection site has been itching for the past 2 days. Tonight it is warm to the touch, with a large red rash about 3 inches in circumference around the injection site. It is still itching and is still is sore.
66 2021-04-08 insomnia 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 anxiety, sleep disorder Day after having my second vaccine I have experienced Tinnitus. Some times it sounds almost like a s... Read more
Day after having my second vaccine I have experienced Tinnitus. Some times it sounds almost like a siren is going off and will last several minutes. I have had it in both ears. It wakes me up at night and I can?t get back to sleep. Have had to use a white noise machine to sleep. It has gotten better in my left ear but still very loud in right ear. It has made me very anxious and on edge. I have also been experiencing vertigo. It comes and goes. I have not fallen down from it yet.
66 2021-04-10 excessive sleepiness After 1st vaccine: very fatigue by next morning lasting 3 days. Arm was sore for ~5 days, then beca... Read more
After 1st vaccine: very fatigue by next morning lasting 3 days. Arm was sore for ~5 days, then became very itchy. After 2nd vaccine: Very fatigued and slightly nauseous for 2 days. Ate nothing on first day and slept for 2 days. Arm sore for ~4 days, and also itchy starting 3rd day. Today, is the 4th day and it is still itchy, tho not as bad as from the first vaccine.
66 2021-04-11 impaired work ability Less than time minutes blurvision,lightheadness,headache,4 hours later nose swallen at bridge with t... Read more
Less than time minutes blurvision,lightheadness,headache,4 hours later nose swallen at bridge with two big hives on both sides.Next morning severe cramp on right leg( Thursday). Friday morning severe pain in upper thigh couldn't work on it,called care source nurse 24/7 number. Called primary Dr. to report what effects I was concerned with. Following Dr.s advice.Today April 12th,2021 pain persists in right thigh
66 2021-04-11 loss of personal independence in daily activities I have been having severe headaches, that have been limiting my activities. I have also starting h... Read more
I have been having severe headaches, that have been limiting my activities. I have also starting having "Hot Flashes" again, since the vaccine. I am an active, and I haven't had these issues for at least 12 years when I was going through the post menopausal, time in my life.
66 2021-04-11 nervousness, anxiety approximated 4 minutes after first dose of covid19 -moderna vaccine Pt started feeling sweaty, sh... Read more
approximated 4 minutes after first dose of covid19 -moderna vaccine Pt started feeling sweaty, shaky, lightheaded. during assessment BP: 174/100 HR: 101 02 sat 98%. Ten minutes after pt's progressively feeling better BP: 153/91, HR:91 02 sat 98%. Offered water and she drank 500 ml. Internal Medicine Dr came to vaccination clinic basement and did a physical evaluation to pt. As per MD Pt was anxious. Pt remained for another 30 minutes and left feeling better stating still feeling mild lightheaded so her son was coming to pick her up. Last vital signs before she leaving BP 150/90, HR 89, 02 sat 98%. Anticipatory guidance for pt and any s/s concern to report to PCP or to go Urgent Care. Pt instructed to take her BP meds as prescribed and to come back to clinic for BP check follow up in one week.
66 2021-04-12 confusional state all food and drink caused strong distaste, enough to halt all eating for 3 days leading to dehydrati... Read more
all food and drink caused strong distaste, enough to halt all eating for 3 days leading to dehydration and weakness. Mental confusion persisting even now. Could not stand for long, had to lie down. Admitted to hospital ER on 3rd day for fluids and observation, diagnosis was "toxic metabolic encephalopathy."
66 2021-04-12 nightmare 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 2021-04-13 disturbance in attention, anger I?m the daughter I don?t know with my 5 year old here screaming and grabbing this device if I hit th... Read more
I?m the daughter I don?t know with my 5 year old here screaming and grabbing this device if I hit the wrong button but I?m not a doctor or the administrator of the shot and her symptoms are still ongoing. Sorry she is sick mad can?t even see from being so dizzy and she?s so tired she can?t focus or stay awake so I?m her daughter trying to fill this out.
66 2021-04-13 feeling abnormal Headache, progressing in intensity to severe with light sensitivity Chills Nausea Vomiting Fatigue M... Read more
Headache, progressing in intensity to severe with light sensitivity Chills Nausea Vomiting Fatigue Moderate to significant arm soreness These symptoms persisted for 18 hours "Brain fog" Occasional lightheaded-ness These symptoms persisted for 3 to 4 days
66 2021-04-13 loss of personal independence in daily activities, feeling abnormal The first one on 3/16/21 only causes soreness for about 2 days. The second one started swelling int... Read more
The first one on 3/16/21 only causes soreness for about 2 days. The second one started swelling into a very hard bump and redness and has remained that way. Also, about 30 hrs. after I received it, I walked to the store (across the street and up 2 buildings) and found myself staggering and struggling to walk straight. I am feeling better today, but not well enough to resume normal activities. I felt "loopy" yesterday, required a couple of 3 hr. naps yesterday and today.
66 2021-04-13 sleep disorder, feeling abnormal 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 2021-04-14 sleep disorder On March 18th I work up with injection site very sore #8 out out of 10. It lasted 5 days which made ... Read more
On March 18th I work up with injection site very sore #8 out out of 10. It lasted 5 days which made sleeping difficult. When the arm pain left I got #* out of 10 pain in my right back shoulder blade. The pain was not surface pain it felt deeper. It would even hurt to breath in deep. It lasted 6 days and than started to come and go for hours at a time. Because I still had intermittent pain I canceled the second dose. It presently is all but gone with just the feeling that I know where the pain was so maybe just a 1.
66 2021-04-15 feeling abnormal Fever 101, nausea, very cold (had to turn up the heat to 80 degrees and lay under 4 quilts), muscle ... Read more
Fever 101, nausea, very cold (had to turn up the heat to 80 degrees and lay under 4 quilts), muscle aches worse than flu, headache, brain fog, severe fatigue, arm felt like I was slugged by the hulk, later when fever broke, extreme sweats.
66 2021-04-15 restlessness Meniere's disease; Leg cramp; Itching; Restlessness; Rash; Nausea; Headache; This spontaneous case w... Read more
Meniere's disease; Leg cramp; Itching; Restlessness; Rash; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (Meniere's disease) 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. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CLOZAPINE for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MENIERE'S DISEASE (Meniere's disease) (seriousness criterion medically significant), MUSCLE SPASMS (Leg cramp), PRURITUS (Itching), RESTLESSNESS (Restlessness), RASH (Rash), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, MENIERE'S DISEASE (Meniere's disease), MUSCLE SPASMS (Leg cramp), PRURITUS (Itching), RESTLESSNESS (Restlessness), RASH (Rash), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. Not Provided Concomitant medications included sleep aid. Treatment for the event included the reporter will consult HCP if symptoms persist. 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. Based on the current 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.
66 2021-04-15 sleep disorder Approximately 9pm the evening of vaccine and every night for 3-4 weeks after receiving the vaccine, ... Read more
Approximately 9pm the evening of vaccine and every night for 3-4 weeks after receiving the vaccine, patient experienced chills and would often wake up around midnight due to night sweats and shivering. Patient also experienced swelling of her foot for approximately two and a half weeks. The swelling was in the arch of her foot and there were some days she could barely walk due to the swelling. Patient alternated between taking Tylenol and Motrin to help with the swelling and also iced her foot. She said she thought about going to the ER but never sought follow up. Currently the patient's foot is still a little swollen, but much better than it had been. Patient is currently not planning to receive second dose of vaccine, however I encouraged her to follow up with her PCP for a second opinion.
66 2021-04-15 sleep disorder The night of the 1st injection, when it was quiet, I realized that I had tinnitus. I did not have t... Read more
The night of the 1st injection, when it was quiet, I realized that I had tinnitus. I did not have this before that day/night. I checked online for that as being a side effect and found that it was not common but some people had developed it after getting the Moderna vaccine. I was a little concerned about getting the 2nd Moderna shot but did not feel that I could change to a different one. I got my 2nd shot yesterday and it seems to be a bit worse than it was before. It is not intolerable but annoying when I am trying to get to sleep.
66 2021-04-16 impaired work ability Started with general malaise in early evening day of shot, then chills, 101.5 fever, nausea, vomitin... Read more
Started with general malaise in early evening day of shot, then chills, 101.5 fever, nausea, vomiting, and then next day developed diarrhea. Unable to eat normally until Friday evening without feeling nauseous. Unable to resume normal work duties until Friday and still then not feeling quite right. Still tired on Saturday.
66 2021-04-17 sleep disorder Acute pain and inability to move arm started two weeks after. Worsening pain, inability to sleep and... Read more
Acute pain and inability to move arm started two weeks after. Worsening pain, inability to sleep and inability to move arm away from body. Anti inflammtories, medrol pack and massage does not help
66 2021-04-20 feeling abnormal Along with slight chills and the temperature of 98F, I experienced unusual sensations (brain zaps) f... Read more
Along with slight chills and the temperature of 98F, I experienced unusual sensations (brain zaps) for a several minutes, on and off. It was not exactly an adverse event but I thought it was interesting.
66 2021-04-21 sleep disorder After Dose #1, I had fatigue but a day later had knee pain which progressively got worse until I cou... Read more
After Dose #1, I had fatigue but a day later had knee pain which progressively got worse until I could not walk. After Dose #2 on March 12, 2021, sharp pains continued involving the knee, the shin, the ankles and feet. The lower half of my body ached so bad I could not sleep. The pain was always worse at night while laying down.
66 2021-04-22 disturbance in attention 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 2021-04-24 mental impairment, loss of personal independence in daily activities 1:25 am 4-25-21 Temperature 97.5 (0.2 degrees lower than normal on the testing equipment) Right fro... Read more
1:25 am 4-25-21 Temperature 97.5 (0.2 degrees lower than normal on the testing equipment) Right front lower gut pain. (not usual for me) both elbows in pain shot in arm in pain dry mouth heat in arm, in and around area of shot urine darker yellow and more profuse than expected 98/73 blood oxygen some stomach nausea. Nausea is not usual for me. 3:14 am 4-25-21 98.1 temp (my usual temp is 97.5-ish 3"35 am 4-25-21 Temperature 98.4, nearly one degree higher than usual. Feeling feverish. Heat in throat. Possibly starting on a sore throat. Extreme nausea. Actually vomited. (It was all water or water-ish). Vomiting for me is highly unusual. Through-out all 3 of these times, I was severely impacted by extreme fatigue; inability to think, move or do things. 11:53 am 4-24-21 Temp 99.5 (this is two degrees higher than my normal temp taken by the same equipment. Extreme fatigue, sore ears, mild head ache (back of the head on both sides. Another bout of chills. 16:38 pm 4-25-21 99.9. My head doesn't feel hot, but my cheeks do. I don't feel nauseated. I do feel like I want to sleep, so I'm going to. I've successfully sat up to type into this report, which is more than I could do this morning. So, when I wake up, I'll take note of how I feel then.
66 2021-04-27 disorientation, amnesia, confusional state 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 insomnia, motion sickness Headache first, motion sickness, Severe lower back pain to where I can't do anything, Severe weak... Read more
Headache first, motion sickness, Severe lower back pain to where I can't do anything, Severe weakness in legs especially left leg, Was able to walk 300ft with the use of cane now can only walk 6ft then pain becomes unbearable, Loss of appetite and thirst , extreme bloating and weight gain, Hardly urinate and diarrhea, Side aches, chest is sore to touch, respiratory is harder to control, Can't keep swelling down in legs unless I lay down all the time, Whole body feels swollen and puffy, losing hair, trouble sleeping, severe drooling, eyes burn and hard to focus even with glasses
66 2021-04-28 anxiety, insomnia Tinitus: Resulting in severe anxiety and insomnia 2-3-2021 ENT , Audiology Exam, Rx Steroid Pack... Read more
Tinitus: Resulting in severe anxiety and insomnia 2-3-2021 ENT , Audiology Exam, Rx Steroid Pack - No Improvement 2-12-2021 TMJ Diagnostics, 2-13-2021 Chiropractic treatment (muliple visits over course of 2 months) 2-14-2021 Urgent Care visit 2-19-2021 ER visit, 2-23-2021 ENT followup 2-23-2021 PCP 3-5-2021 Brain MRI 3-16-2021 PCP followup 3-17-2021 Audiologist 3-25-2021 PCP followup 3-31-2021 ENT followup 4-1-2021 PCP followup
66 2021-04-30 depressed mood, loss of personal independence in daily activities, nervousness, sleep disorder, anxiety 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 2021-04-30 feeling abnormal 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 2021-05-03 feeling abnormal, disorientation, nervousness, memory impairment She got her vaccine, and felt weak and disoriented to begin with and broke out into a sweat and does... Read more
She got her vaccine, and felt weak and disoriented to begin with and broke out into a sweat and does not remember much after that. Vaguely remembered somebody asking her if she was okay. She was sat down and felt like she was coming back. She does not remember anything for the next 32 hours. She vaguely remembers being in the car, knows that she was seeing double cars in front of her, felt like she was in a dream. The traffic lights were like a film. Her daughter said that she saw her in Knoxville which was 35 minutes from where she was supposed to be. Then had a doctors appointment and was told that she was not her. It then took her 4 hours to get home, which is normally a 45 minute drive. She does not remember where she had gone. She was very shaky inside and got home and went to bed. She is still having that shaky inside feeling. She went to bed and did not get up until Friday night when her grandchildren came to the house. She got up and could not remember them being there and them playing, does not remember them leaving, and does not remember locking up her house. She met her daughter on Saturday and told her what was going on and she told her to go back home. She was shaky with her hands and spilled everything. She cannot remember anything, and not able to tell distances. She can remember of different times of slamming on her breaks and almost hitting things. The drug store called and nobody knew where she was for the 32 hour period of time. This fogginess is kind of going away now, but still has the real shaking inside like she's had too much caffeine. She called her doctor and left a message for them to call her back.
66 2021-05-03 feeling abnormal currently at 8 weeks of daily headaches. I have taken antibody tests for the covid virus and results... Read more
currently at 8 weeks of daily headaches. I have taken antibody tests for the covid virus and results are NEGATIVE. Brain fog began to calm at about 5 weeks. I now have strong tingling and numbness in my feet and calves. Sometimes my legs feel weak. In the last 2 weeks, my knee joints are swollen and I cannot fully bend. In addition to swollen joints, I have increasing joint pain in knees and hips and aches in my back and legs. Continued tightness in the back of my neck.
66 2021-05-04 insomnia 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 2021-05-04 loss of personal independence in daily activities Continuing pain, 2 months later at injection site. Position causes pain when lifting object or turni... Read more
Continuing pain, 2 months later at injection site. Position causes pain when lifting object or turning arm. No change in intensity over time. Feeling extremely fatigued and weak. Unable to do activities I could do before the 2nd vaccine
66 2021-05-05 loss of personal independence in daily activities Covid shot Feb. 3,2021 Moderna Keep in... Read more
Covid shot Feb. 3,2021 Moderna Keep in mind I did not put all the pieces together until a month later. Very important to note my hands are very strong, like vise grips, so to wake up not being able to make a fist was very difficult, not to mention not being able to pull up my underwear. Feb 4,5,6,7 Redness on Left arm, no real aches or pains. Continued to work, wasn?t feeling so good, legs very tired. Left work early 2/11 and 12. Was out 2/18 left 1hr. early 2/19 Feb 18th went to see DR. complaining of muscle weakness and aches in my hands and legs. Stiffness in hands I thought was because of walking with the cane. Then left hand started hurting. Strangely keep burping for no reason. Noticed my pelvic floor are weak. Just standing up and my bladder starts to leak. Frustrating.. I am dealing with Lymphedema in legs and bad knees, so all these aches and pains are common. Took the week of 2/22 to 2/26 off of work to relax, hoping to recover. Things got a little better when I got back in pool therapy. Went to see Ortho DR 2/24 he drained 65ml of fluid out of the left knee, and 45ml out of right knee. Got a Gel One injection both knees. No help. Went to see Ortho Dr. , who informed me that all has been done to help, time to replace knee. Feb. 27,28, Feeling better, started questioning Covid shot side effects after seeing an article on TV. Thursday 3/4 Dr did not think my aches and pains were from the shot. So Only way to know for sure was to have second shot, March 6TH. 2nd shot March 6th All went well, redness on left arm Sunday. However Sunday night got the chills, then woke up sweating. Hands to the elbows stiff and could not touch the top of my head. Every muscle and joint aches. Knees and feet all swollen. Pain on right side of neck. Takes me over an hour to stretch and bend just to get out of bed. My feet are elevated all night. Lower them to stretch. Sometimes legs feel like their on fire?? 3/8 Monday aches and pains. Tuesday Major stiffness felt like passing out in the shower, went to the Pool. Therapist had me keep arms lowered in the water flexing and stretching to get fluid to move. Felt a little better, but weak. Still burping for no reason. Still pain on right side of neck. Tuesday and Wednesday night same thing happened, chills then sweating. Thursday in the pool was tough. Chills and sweating again at night. Major stiffness Friday, Sat and Sunday mornings. All day burping and hands very stiff/cold. Used heating pad to loosen up hands. 3/15 Monday morning woken up with chills again, hands so stiff and legs throbbing, having a difficult time getting out of bed. Went to take a shower, thought I was going to pass out. Pain on left side of neck. Stiffness elbows to finger tips. 3/16 and 3/18 pool therapy giving some relief with stiffness in hands and legs. 3/19 to 3/22 woke up with stiffness in hands to elbows. Left arm where the injection shot was given felt like someone was snapping an elastic on my arm every couple of minutes. Finally got it to go away by putting heating pad on it every morning. I also put heat on stiff hands, that seems to work a little. But the burping still won?t stop, my stomach just keeps rolling no matter what I eat or drink. On days that I did not have pool therapy it would take 3 to 6 hrs to get hands to loosen up using heating pad. 3/23 went to pool therapy, had a tough time walking in/out. Legs feel like they can?t hold me up. Therapist had me work out again, trying to move the fluid out of my legs and arms/hands. By the time I got home hands were cold and stiff, feet feel tingly.. 3/23 Called primary care to discuss fluid in hands and legs, got the OK from both Dr?s to take fluid pill and also a Prednisone (4 days only) to flush my system. 3/24 to 3/26 still getting the chills and stiffness in hands, not a bad, finally going away?? Hopefully. 3/26 to 3/29 hands are finally loosening up, not as much stiffness, only takes couple of hrs. of get hands to function. This has been a very difficult recovery.. April 5th had my knee replaced, what ever medicine they gave me, my hands were not swollen at all 3 days then I went to Rehab and the swelling started all over again. Today is May 6th and the hands are still cold and slightly stiff. The stomach is still burping. Pelvic floor getting better. Only asking if you heard of this and if you have a cure? Need my blood to Test? Would like to have my life back to normal. Thank you,
66 2021-05-05 panic reaction, nightmare Continuous nightmares. Woke up last night in a panic from the nightmare, feeling dizzy and nauseous ... Read more
Continuous nightmares. Woke up last night in a panic from the nightmare, feeling dizzy and nauseous and shaking. The nightmares started several days after the shot. The ringing in my ears are so loud too. I thought the ringing was going away but they have come back. I never get nightmares so this is so unusual for me.
66 2021-05-07 anxiety, suicidal thoughts I could taste the shot at the time of the vaccine. The next day I became nauseous and overly anxiou... Read more
I could taste the shot at the time of the vaccine. The next day I became nauseous and overly anxious to the point where I felt I was going to hurt myself. I kept telling my close family that something was wrong. My son wanted to take me to the hospital and sent Deputies to my house for a wellness check. The nausea and the feeling of being on the edge of suicide kept on for 5 full days. I really thought I was going to kill myself.
66 2021-05-09 anxiety per medical report from hospital- "presented to emergency room at outside facility secondary to wors... Read more
per medical report from hospital- "presented to emergency room at outside facility secondary to worsening shortness of breath. The patient states that about 1 week ago she started feeling ill directly after receiving her first covid vaccine. the patient states her medical issues actually began approximately 2 months ago when she developed sudden onset positional urinary retention as well as urinary incontinence and constipation. She states that she thought maybe her known spinal stenosis had worsened causing her bladder dysfuntion.She states she tries to sit on a commode or a toilet and is unable to void however when lying flat she has to wear adult briefs as she has no control over her bladder at all. There is no p
66 2021-05-13 confusional state "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 2021-05-15 excessive sleepiness First injection 3-20-21. Left arm sore and trouble raising it for at least one week. On 3-30-21, I... Read more
First injection 3-20-21. Left arm sore and trouble raising it for at least one week. On 3-30-21, I went to hospital for numb left arm and being nauseous. No heart issues, but possible pinched nerve. Still problems with left arm being numb at times. 2nd injection - Slept for most of 36 hours after injection on 4-26-2021. On 5-14-21, I discovered a magnet will stay on my arm at the injection site. This was done after talking with co-workers who saw this done on the internet. During this time, several people also discovered they had a magnetic site. Is this normal? And why would my arm be magnetized? Conspiracy theories are being discussed now.
66 2021-05-16 confusional state Patient called to report that Moderna #2 vaccine received on a Tuesday. Woke up on Wednesday morning... Read more
Patient called to report that Moderna #2 vaccine received on a Tuesday. Woke up on Wednesday morning with "really bad headache", "very confused" and "very weak". Denied any fever or chills. Now 2 weeks later she still has lingering leg weakness, "very weak" and fatigue and also hair loss. She says she had no after effects with Moderna #1. She is now "getting back to normal" .
66 2021-05-19 feeling abnormal, insomnia Every joint in my body ached. No fever. Couldn?t sleep. Head ache. Couldn?t get warm. Felt like a tr... Read more
Every joint in my body ached. No fever. Couldn?t sleep. Head ache. Couldn?t get warm. Felt like a truck ran over me
66 2021-05-19 motion sickness Right after vaccine: Slight fever and extreme fatigue. May 8-present: Severe headache, nausea, moti... Read more
Right after vaccine: Slight fever and extreme fatigue. May 8-present: Severe headache, nausea, motion sickness, lightheadedness, joint pain.
66 2021-05-19 suicidal thoughts Patient reported suicidal thoughts after receiving vaccine. Since vaccination, she reports fecal and... Read more
Patient reported suicidal thoughts after receiving vaccine. Since vaccination, she reports fecal and urinary incontinence. She has stated that she called her cardiologist and went to PCP. Patient has referral to psych.
66 2021-05-24 confusional state, feeling abnormal Brain fog/ tired/ confusion
66 2021-05-28 feeling abnormal 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 2021-05-31 amnesia, impaired work ability, confusional state 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 insomnia Hearing sounds amplified; Sweating; Does not feel well; Trouble sleeping; tinnitus; migraine headach... Read more
Hearing sounds amplified; Sweating; Does not feel well; Trouble sleeping; tinnitus; migraine headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of TINNITUS (tinnitus) and MIGRAINE (migraine headache) 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. No Medical History information was reported. 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 28-Mar-2021, the patient experienced TINNITUS (tinnitus) (seriousness criterion disability) and MIGRAINE (migraine headache) (seriousness criterion disability). On an unknown date, the patient experienced HYPERACUSIS (Hearing sounds amplified), HYPERHIDROSIS (Sweating), MALAISE (Does not feel well) and INSOMNIA (Trouble sleeping). The patient was treated with SUMATRIPTAN SUCCINATE (IMITREX DF) ongoing since an unknown date at a dose of 1 dosage form and METHYLPREDNISOLONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, TINNITUS (tinnitus), MIGRAINE (migraine headache), HYPERACUSIS (Hearing sounds amplified), HYPERHIDROSIS (Sweating), MALAISE (Does not feel well) and INSOMNIA (Trouble sleeping) 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, Fibrin D dimer: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications taken by the patient were not provided. Action taken with mRNA in response to the event/s was not applicable Very limited information regarding the events has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up information include:In general tab reporter details updated ln patient tab lab data includedIn product tab vaccine information updated and treatment information added.In event tab 2 events are added; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.
66 2021-06-02 depressed mood, feeling abnormal 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 2021-06-06 feeling abnormal 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 2021-06-08 impaired work ability, feeling abnormal I assumed I had bronchitis shortly after getting the first shot. I'd seen my doctor and was given pr... Read more
I assumed I had bronchitis shortly after getting the first shot. I'd seen my doctor and was given prednisone. I continued to have brochial symptoms that have not let up for at least 3 months. I have constant coughing spasms which become constant when in a lying position. I was also given an antibiotic during the last few months by my PCP. I kept thinking it was bronchitis, allergies, the pollen. But this is really getting scary. My friends and family are noticing it now. I can't talk to anyone too long. I've had to take time out of work. I had a breast reduction scheduled. I mentioned all of this to the surgeon and he didn't seem concerned, but again, I thought it was related to bronchitis. I had my surgery. My breathing was very poor after the surgery and for at least a week. I couldn't get a breathometer up even a quarter of the way. I have constant wheezing when I exhale. I never had a breathing problem like this before. My PCP referred me to a lung specialist, but I haven't an appt until July. I haven't smoked a cigarette in over 40 years. This is getting very scary and worrisome for me.
66 2021-06-11 impaired work ability 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 2021-06-12 impaired work ability On four days, starting on 4/30/21 and through 5/7/21, and on two additional days, one 1 week later ... Read more
On four days, starting on 4/30/21 and through 5/7/21, and on two additional days, one 1 week later another two weeks after that, I had the following symptoms: Nausea, diarrhea, stomach discomfort, mild headache, malaise and fatigue They were bad enough to miss work on the days that fell during the workweek.
66 2021-06-18 feeling abnormal One hr after second shot I became extremely tired. Had to go home and go to bed. Was there rest of t... Read more
One hr after second shot I became extremely tired. Had to go home and go to bed. Was there rest of that day and into second day. Few weeks later knees, fingers, back started locking up. Very weak. Muscles and joints painful. Unbelievable exhausted. Still going on. Getting worse
66 2021-06-20 mental impairment, feeling abnormal 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 2021-06-22 irritability I have developed a facial spasm/tremor/twitch on the left side of my face, on my cheek. Wearing a ma... Read more
I have developed a facial spasm/tremor/twitch on the left side of my face, on my cheek. Wearing a mask or CPAP makes it worse, but it persists even when I haven't been wearing a mask. Dr. advised taking 500 mg Naproxen twice a day and avoiding Fexofenadine ( as well as Topamax, which I was no longer taking). He has referred me to a neurologist at medical center who I will be able to see on 07/26/2021, possibly for a Botox injection. The spasms are uncomfortable and annoying and sometimes leave my cheek feeling sore.
66 2021-06-27 feeling abnormal Head had strange feelings as something traversing throughout the blood vessels. This sensation persi... Read more
Head had strange feelings as something traversing throughout the blood vessels. This sensation persisted for 3 days. I knew to expect my arm to hurt for several days, but pain persisted for 5 weeks.
66 2021-06-30 disturbance in attention I woke up around 11:00PM in extreme pain and I was nauseated. My back started hurting and I called 9... Read more
I woke up around 11:00PM in extreme pain and I was nauseated. My back started hurting and I called 911 because I was unable to walk. I was completely dehydrated. I was given magnesium and potassium for about 6 hours. My lymph nodes in neck area were very sensitive to the touch. I could not focus at all. The doctor felt like it was the vaccination but also a combination with me taking the water pill.
66 2021-07-06 sleep disorder After 3-4 days after the vaccine in my left arm I had a lot of shoulder pain. It got worse and worse... Read more
After 3-4 days after the vaccine in my left arm I had a lot of shoulder pain. It got worse and worse to where I could not even use my arm, I could not sleep at night it was so painful. It was not at the injection site, it was actually at my shoulder. It hurt to touch it and it hurt to move it. I waited it out to see if it would get better. I could not use my arm to even hold my coffee cup or anything. I kept thinking it was going to get better and it would get better but it didn't. I went to my PCD on 4/8/2021 and saw a PA, not the DR. She prescribed anti-inflammatory and gave me a prescription for physical therapy. She said it was probably my rotator cuff, which I never had any trouble with at all before. The anti-inflammatory worked while I was taking it, it took the edge off but after I stopped taking it, the pain returned. I called the DR back in May and asked to see the DR but I cannot get an appointment until July 19, 2021. I am also doing physical therapy right now for my right shoulder.
66 2021-07-07 sleep disorder Got recommendations from a NP after first one, and stayed on Benadryl, felt feverish and took it eve... Read more
Got recommendations from a NP after first one, and stayed on Benadryl, felt feverish and took it every 4 hours around the clock, as well as Advil and just continued on that regimen for about a week and then started taking Zyrtec as she was not getting any sleep waking up every 4 hours and then continued that for about 2 weeks, and scared about the reaction from the 1st vaccine. Then took herself off the Zyrtec about 3 weeks later and went off for 24 hours and then her arm started to itch again and then took that for 2 days and then stopped that and is under control. Her energy level did not return for a while, and did feel some enlarged lymph nodes after the vaccine as well.
66 2021-07-08 loss of personal independence in daily activities It seems that I had what is called a "Covid Arm" Around the injection site, it got red and hard to ... Read more
It seems that I had what is called a "Covid Arm" Around the injection site, it got red and hard to the touch. The area was a little swollen, and warm. The worst part was the itching, which it was really, really intense. . I applied ice and a cortisone cream. It lasted two days. I felt very tired during the first week. I didn't have any of those side effects after the 2nd dose, which it was administered on February 27, at 2:30. (Moderna, lot:013L20A). But, I remained very tired for more than a month. I could hardly made any house chore.
66 2021-07-12 mental impairment, memory impairment, feeling abnormal SEVERE MUSCLE AND JOINT PAIN RADIATING FROM LOWER BACK TO BOTH GROIN AREAS WHICH RADIATED DOWN TO BO... Read more
SEVERE MUSCLE AND JOINT PAIN RADIATING FROM LOWER BACK TO BOTH GROIN AREAS WHICH RADIATED DOWN TO BOTH KNEES ANKLES AND FEET LASTING 24 HOURS. MOOD SWINGS, ACUTE DEPRESSIVE SYMPTOMS LASTING 2 DAYS. FOGETFULLNESS .FATIGUE AND FOGGY THINKING LASTING TWO WEEKS. SEVERE INJECTION SITE PAIN LASTING SEVERAL DAYS (7) WITH REDNESS. TENDERNESS AND SWELLING AT INJECTION SITE . INTERMITTENT LIGHT HEADED EPISODES. HEADACHE LASTING ONE DAY.
66 2021-07-13 insomnia Tinnitus with loss of sleep and headaches
66 2021-07-15 irritability, depression Immediate symptoms were extreme hunger (eating everything in sight despite being on Weight Watchers ... Read more
Immediate symptoms were extreme hunger (eating everything in sight despite being on Weight Watchers and having been perfect for a year and losing 28 lbs) and then the normal reactions (slight fever, mild body aches, etc) for a day or two. Got all better from that. Then on day 4 after the 2nd shot, out of the blue, I got very moody and irritable for no reason. And I have been experiencing what feels like a biologically-based (rather than reaction-to-life-events-based) feeling of depression ever since. Along with that I have experienced: mild nausea wierd food cravings (for intensely spicy,sour, salty foods.. not usual for me) (Continued on continuation page, please read) Fatigue (had to start drinking coffee again to wake up in the morning, after not drinking or needing coffee for the past 10 years. The main effect I've experienced is depression, which is NOT normal for me. I've always been a very upbeat person... even in the face of difficult or even tragic life events. My normal personality has always been set to "upbeat and cheerful". The shot seems to have reset this to "downbeat and apathetic" which is not usual for me and not helpful at all. I need my normal can-do personality to function in my life and work. The depression started suddenly and for no apparent (life-based) reason, four days after my 2nd shot. Have consulted my therapist on this and also my medical doctor. I reported it to V-safe and they told me to report it to you. All of my symptoms would make perfect sense if I were... pregnant. But considering I'm 67 years old, 10 years past menopause, and haven't had a man in my life in many years, there's no way short of a Biblical event that that could possibly be the case. I continually feel hungry and like I can't get enough to eat. I am trying to continue my weight loss journey so that is especially hard. I'm slowly getting better from the depression, but it's been a long process. It doesn't seem like a therapy-based solution is the answer, more physiological. I've been using the mushroom elixir coffees and supplements: This has been the most helpful thing for me I am very sensitive to medications and I don't take any Rx other than my three blood pressure medications. Have never taken (nor, till now, needed or considered) anything for depression. I didn't have wierd food cravings when I was ACTUALLY pregnant. But now it's like I HAVE to have sour lemon juice with pickle juice and hot sauce. I am not making this up.
66 2021-07-17 feeling abnormal 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 disturbance in attention 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 2021-07-20 impaired work ability After vaccine, had severe joint and muscle aches, chills, headaches, lasted about 24 hours, then had... Read more
After vaccine, had severe joint and muscle aches, chills, headaches, lasted about 24 hours, then had extreme fatigue, nauseauh, 99.6 fever (usually 97).skipped work. Took advil
66 2021-07-21 feeling abnormal Right after vaccine - I was running fever of 101. I called the doctor's office the next day and she ... Read more
Right after vaccine - I was running fever of 101. I called the doctor's office the next day and she said it was normal. I called the next day after that as I still was not well. The next week, (25th of January) I went in and they were telling me they wanted me to take the second vaccine but I felt terrible and I had ringing in ears and it felt like ears were full of fluid. And my sinuses - it felt like my head was blowing up. She put me back on Prednisone - it was tapered dose prescription. I had lingering sinus and ear problems.- He put me on antibiotic for two weeks and another tapered dose of the prednisone. I took those for two weeks and I was better. Dr. (on Feb 19). I had my antibodies drawn the week before I had the vaccine but I didn't get the results back until after I had taken the vaccine. I had antibodies. I would not have taken the vaccine if I would have known I had the antibodies. I have a slight ringing in my ears right now but it's not as horrible as it was. My left ear is the worst. I think the left side of my body is the weakest part of my body. Dr. - he's a rheumatologist - another doctor of mine - told me that he had the COVID in September and I may have gotten it from him that day that I saw him. He said it was up to me if I wanted to get the 2nd vaccine. Note: I started taking allergy shots in February 2021 after the vaccine - allergic to dust, molds and pollens.
66 2021-07-27 panic reaction, sleep disorder I carry a low grade infection in my ears, being checked out from an ENT specialist this gets aggrava... Read more
I carry a low grade infection in my ears, being checked out from an ENT specialist this gets aggravated whenever I try to take a vaccine. I don't seem to carry a fever with it but I get sensation of hotness, heat between my ears happens two weeks after my vaccine occurred on 06-18-2021. Two weeks later I began getting symptoms of vertigo that included severe nausea which I never get. I had severe spinning, like the room was spinning. My ears were popping and with mild pressure to my right and left ear. On 06-25-2021, the intensity was a 6, unidentified inflammation on my head. I felt a swollen sensation triggered by laying down and turning my head to the sides, it was also my sensation that I felt like I was going to faint. On 07-01-21, I had a jolt sensation to my neck, top of my neck, below where the neck meets the skull and literally woke me up at night happening days and times. On 07-02-2021, intensity of 9 head movement, severe nausea and movements to go puke. I had the shakes and face was burning and face turned red. I had sensation of a pressure being pulled from my face, the muscles in my were curling with pain. I have prior cervical radiculopathy. I went to lay down, I had nausea and dry mouth and also had difficulty swallowing. I had dry heaving as well and also had panic feelings as well. On 07-06-21, severe episode with nausea and burning sensation in my right ear. On 07-20-21, blood rushing to my cheeks and mild sensation of spinning, vertigo. Today I still have on random days, mild nausea, crackling and popping and feeling in my ears.
67 2020-12-31 feeling abnormal 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 2021-01-03 disorientation Severe left arm pain, stiffness. Left shoulder pain. Neck pain. Stated she couldn't lift her left... Read more
Severe left arm pain, stiffness. Left shoulder pain. Neck pain. Stated she couldn't lift her left arm for three days after the vaccine. Low grade fever. Reported feeling disoriented, sweating, no appetite for a couple days. Fever has resolved, but other symptoms still remain. Advised employee to call doctor to report symptoms and get advise regarding next vaccine.
67 2021-01-04 sleep disorder Intense itching in an area about two inches below injection site which started about six days after ... Read more
Intense itching in an area about two inches below injection site which started about six days after the first injection of Moderna vaccine. Also swelling ( a firm lump). Itching intense enough to disrupt sleep. Over the counter remedies did not help. Cold pack did not help.
67 2021-01-05 fear 5 minutes after injection, my feet and palms itched and I was lightheaded but I tried to shake it of... Read more
5 minutes after injection, my feet and palms itched and I was lightheaded but I tried to shake it off and it faded over the next 10 minutes. I did report it and stayed longer and was ok. Then i went straight home and layed down because i did not sleep well night before (was on call ) i awoke 1 hour post injection dry heaving, very nauseated, mild headache, achy, itchy over different parts of my body and weak. Sat up and my face was getting itchier, lips started to swell, tongue started to swell and itch, throat felt like someone was strangling me, had trouble swallowing and trouble breathing. took 2 benadryls immediately and went out into cold air, thought about calling 911 but got better in 10-15 minutes. never have had a reaction like this in my life. have had hives though in the past. If I would have had an epi pen I would have used it (never have had an epi pen) I was frightened but the benadryl worked and I slept due to the benadryl for 5 hours, when I woke up the benadryl wore off and it started again. took more benadryl, and it improved. before bedtime, the benadryl wore off and I had a hard time swallowing my night time meds like my throat was swollen. Took 2 more benadryls, today I am weak and nauseated and ate very little and feel like my face is still red and itchy. I told my sister and she said she is allergic to PEG which i later noted was in the vaccine. i am very disappointed that I had this reaction- I have desparately wanted this vaccine as a medical worker with a lot of covid patients- I onlu hopr this one shot will protect me enough because it is clear to me that i cannot take this vaccine again.
67 2021-01-06 nervousness I received the vaccine yesterday 1/6/21. Today, 1/7/21, I went for my walk this morning and felt of... Read more
I received the vaccine yesterday 1/6/21. Today, 1/7/21, I went for my walk this morning and felt off balance/swayed to the right a bit at one point. I don't think lightheadedness precipitated this, but it unnerved me. I steadied myself and finished the walk without a problem. I checked and surface/pavement was uneven. My temp is 97.5 and I feel fine now but am just a little nervous that is a possible reaction to the vaccine. I had a reaction to the second dose of the hepatitis B vaccine 10 yrs ago, I fainted in early morning hours after getting up to go to bathroom. I had received the second dose at about 11:30a the day before, and developed flu like symptoms by afternoon with a fever and ended up dehydrated which I think contributed to my fainting at about 3a when I got up to void. I had a concussion and was treated with IV fluids at the local ED.
67 2021-01-07 feeling abnormal Patient complained of feeling like she "swallowed a feather or a cat hair" - her lungs were tickling... Read more
Patient complained of feeling like she "swallowed a feather or a cat hair" - her lungs were tickling. She said she felt fine, but wanted to be sure to report the "strange feeling". Patient said she feels well, but wanted to contribute to research. Patient advised to call 911 or go to the nearest emergency room for any further issues.
67 2021-01-07 nervousness Patient appeared nervous upon receiving vaccine. Patient reported trouble swallowing ( has a history... Read more
Patient appeared nervous upon receiving vaccine. Patient reported trouble swallowing ( has a history of radiation therapy on throat). When asked if breathing was restricted, patient was able to take long breaths with minimal additional effort. Shortly after, patient appeared to be close to passing out (not completely awake and alert), eyes dilated. The pharmacist who administered the vaccine then administered one dose of the epinephrine (Epi-pen LOT:0FM353/eEXP:NOC 21) while the staff member kept the patient stable in her chair. The facility was instructed to call 911. At 11:49 AM (7 minutes later), symptoms began to improve and the patient became more alert. EMS arrived around 12:00PM to take patient to hospital--patient refused and was back walking around the facility 5 minutes later. No further issues were reported with this patient (pharmacist administering the vaccine left the facility around 1:15PM)
67 2021-01-09 sleep disorder Initial soreness at injection site gradually subsided over the course of 1 week. On day 11 pain at i... Read more
Initial soreness at injection site gradually subsided over the course of 1 week. On day 11 pain at injection site woke me during the night. There is an approximately 2.5 inch raised area slightly warmer than surrounding area and very tender to touch. Some itching at the site.
67 2021-01-10 feeling abnormal No symptoms on 1/8. Saturday 9pm inj site was sore. 1/10, 3pm, began to get a headache, terrible, ba... Read more
No symptoms on 1/8. Saturday 9pm inj site was sore. 1/10, 3pm, began to get a headache, terrible, banger of a headache, took Tylenol. Headache all night long. 1/11 2am got nauseated to the point of vomiting. Runny nose and coughing. Finally woke up this am with muscle pain. The headache is better, but still feels pressure. Feels bad all over, flu like, flushed, feverish. Right kidney pain, started today.
67 2021-01-10 nightmare, feeling abnormal Chills Body aches Fatigue Site soreness Joint pain Intermittent headache Nightmares 3-4 times per ni... Read more
Chills Body aches Fatigue Site soreness Joint pain Intermittent headache Nightmares 3-4 times per night that are very realistic Brain fog
67 2021-01-11 disorientation 3:28 patient feels dizziness, blurred vision, states she is having trouble focusing her vision. C/O... Read more
3:28 patient feels dizziness, blurred vision, states she is having trouble focusing her vision. C/O feeling flushed and feeling disoriented. It oriented to person, place, and time upon further assessment. Denies itching or feeling hot. Is experiencing shakiness, does have hand trembling. EMT from vaccine site in attendance. BP 118/66; HR 76; O2 sat 98% on r/a. EMT recommended ambulance transport, patient refused. 3:36 HR 68. 3:45 BP 122/68; HR 67; O2 sat 97% on r/a. 3:50 Patient requested to go to restroom. Attended by nurse P. H. Patient states she feels like her skin is crawling. With assistance examined abdomen region. No redness, swelling or hives noted. 3:54 Patient left with assistance of facility w/c to awaiting personal car driven by husband.
67 2021-01-11 mental status changes Attempting to confirm which COVID 19 vaccine was given (Moderna or Pfizer). They did not send the re... Read more
Attempting to confirm which COVID 19 vaccine was given (Moderna or Pfizer). They did not send the record when they sent the patient to General ER the next am. Did not answer the phone.
67 2021-01-17 feeling abnormal 8 days after immunization, patient noticed red, swollen and itchy area around immunization area, lat... Read more
8 days after immunization, patient noticed red, swollen and itchy area around immunization area, later that night she felt that her tongue and throat were swelling and she had a very strange feeling. She went to the ER and they gave her Benadryl and Prednisone and her symptoms resolved
67 2021-01-19 anxiety 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 2021-01-19 anxiety Per Dr: Patient complained of lip and tongue swelling at 13:!6 after receiving Moderna vaccine. BP 1... Read more
Per Dr: Patient complained of lip and tongue swelling at 13:!6 after receiving Moderna vaccine. BP 167/102 and HR 94, O2 98%. No SOB, no pruritus, no rash. Given Benadryl 25mg at 13:19 with prompt improvement. Symptoms started to recur and second dose of Benadryl 25mg given at 13:29. Patient comfortable until 13:35 when she looked less comfortable, complained of difficulty swallowing, looked anxious and uncomfortable. Continued to progress but denied SOB. BP 214/116 HR 109. Epi-pen given x 1 at 13:43 - concern that episode pen did not deploy. Epi given again at 13:45. BP 187/95, HR 121, O2 sat 100%. Patient subsequently improved with less anxiousness, less difficulty swallowing. Patient transported to UTC at 14:05. Lot 042L20A
67 2021-01-19 anxiety rash all over entire body and anxiety
67 2021-01-20 anxiety Five minutes after receiving the vaccine , patient reported nausea, dizziness, stomach cramps, and f... Read more
Five minutes after receiving the vaccine , patient reported nausea, dizziness, stomach cramps, and feeling anxious. Patient supine with feet elevated above heart. Patient remained supine for 10 minutes and started to feel better. Vitals assessed. Patient reported feeling better and requested to leave. Pt observed walking out of the building with family approximately 35 minutes later .
67 2021-01-20 anxiety 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 2021-01-20 feeling abnormal, mental impairment Pt stated she felt foggy and had difficulty thinking straight. Pt was assisted to the floor and took... Read more
Pt stated she felt foggy and had difficulty thinking straight. Pt was assisted to the floor and took Benadryl 25 mg orally from her own supply that she came with. Pt provided water and was monitored. Pts husband also present. Pt was asked to rest and after feeling bit better she sat up, then was moved to a chair and monitored for an additional timeframe. Before leaving pt stated she was feeling well.
67 2021-01-21 feeling abnormal Chills for an hour, then foggy head, then dizzy, then so very tired so took Tylenol and took a 3 HR ... Read more
Chills for an hour, then foggy head, then dizzy, then so very tired so took Tylenol and took a 3 HR nap. Got up and felt clear headed but still tired so rested 2 more hours.
67 2021-01-22 sleep disorder Pain, swelling & redness of upper arm around injection site, starting 3 days after injection and inc... Read more
Pain, swelling & redness of upper arm around injection site, starting 3 days after injection and increasing each day until about 14 days after injection when swelling and redness began to decrease. At its largest, swelling was about an oval about 2-1/2 wide x 3-1/2 long. Pain was significant enough that I couldn?t sleep on my right side. Swelling and redness are gone, but area is still tender to the touch.
67 2021-01-24 impaired work ability Arm started hurting , felt tired, had chills, head aches and body aches last for 36 hours, went to... Read more
Arm started hurting , felt tired, had chills, head aches and body aches last for 36 hours, went to work and work got worse at work and workplace sent home.
67 2021-01-24 insomnia When she came home started getting really cold around 5:30 pm yesterday. Started having chills all ... Read more
When she came home started getting really cold around 5:30 pm yesterday. Started having chills all night and slept with winter coat on. Started getting sick to her stomach all evening, started throwing up last night beginning at 11:00 PM, throwing up bile. Today having fever of 101, didn't take anything for it, but down to 100 now. Took 2 Tums and had such achy joints and sat down in a chair and could not get up from the chair. Took some Tylenol and that helped, but freezing cold. Didn't sleep all night. Has not notified her doctor of the symptoms, just calling us.
67 2021-01-25 feeling abnormal When my fingers touched something cold they would feel weird and lose their color. The first time (1... Read more
When my fingers touched something cold they would feel weird and lose their color. The first time (1/21) was minor (one finger) and the second time was (1/23) and all the tips of my fingers of my right hand turned colorless when I touched something cold. 1/24 my toes tingled when I walked and happens when I go for a walk. The finger symptom seems to be diminishing. I have never had either of these things happen before I had the Moderna vaccine. My doctor told me not to have the second dose which is due on 1/30/2021.
67 2021-01-25 sleep disorder Headache, Myalgia, Arthralgia & Fever Narrative: woke in middle on night the day after shot feveris... Read more
Headache, Myalgia, Arthralgia & Fever Narrative: woke in middle on night the day after shot feverish, and with other s/s as noted above.
67 2021-01-26 anxiety Approximately 10 minutes after injection, felt an unusual sensation up my right arm, neck, into left... Read more
Approximately 10 minutes after injection, felt an unusual sensation up my right arm, neck, into left ear. While driving home my face became warm, after arriving home face/cheeks extremely red/flushed. Have a picture taken at 3:54 for documentation. Not sure if from anxiety, but felt jaw tightness and a thick tongue. No itching, swallowing problems etc. lasted approximately 15 minutes. By 4:57 pm redness had faded. Picture documentation. 9:15 pm had right ear pain and mild reddened of right cheek. Picture documentation.
67 2021-01-26 feeling abnormal RN followed up with patient as she was having adverse she effects from COVID Moderna Vaccine, She st... Read more
RN followed up with patient as she was having adverse she effects from COVID Moderna Vaccine, She stated after she spoke with RN yesterday she was feeling "crummy."She complained of headache, achiness, fever from 99.2- 100.4, and felt nauseous. She stated she took Advil and was feeling better but this morning she still hada temperature of 100.4, though she stated she was feeling better in general. She requested RN send this additional information to CDC. RN reviewed supportive care with her and to follow up with her provider tomorrow if she still has a fever of 101.4.
67 2021-01-27 hallucination, nightmare, impaired work ability Had first COVID vaccine 12/28/21. Had shivering the next day then felt fine. Received second dose 1/... Read more
Had first COVID vaccine 12/28/21. Had shivering the next day then felt fine. Received second dose 1/25/21. Woke up at 3:30am with vomiting then began to shiver, was flushed, developed body aches, and discomfort to lower extremities. Called off work. Symptoms remained the same all day. Slept 15 hours then woke up in am 1/27/21 and was hallucinating. Saw huge spiders on her wall. She had nightmares the previous night also. Hallucinations stopped when she got up. Other symptoms continued through the rest of the day. Also had pain in arm so she couldn't lift above shoulder level. Went to bed and had nightmares that night. Woke up and had trouble walking without stumbling. All symptoms began resolving around 2pm. Went to bed the night of 1/27/21 and still had some nightmares then woke up and returned to work. Today she is having indigestion and diarrhea. No hx COVID disease.
67 2021-01-27 loss of personal independence in daily activities I received the 2nd dose at 0900, the took Ibuprofen 200mg and 1 Zyrtec tab at 10am. I had no symptom... Read more
I received the 2nd dose at 0900, the took Ibuprofen 200mg and 1 Zyrtec tab at 10am. I had no symptoms until 0500 the next morning, 1/26. I woke up with aching joints, aching eye sockets, hyper sensitive skin sensations, slight headache, abdominal cramping, and lethargy. The abdominal cramping subsided in a few hours. I slept the whole day, missing a day of work. I took Ibuprofen 200mg at noon. On 1/27 at 0100 am, I woke with aching joints and skin hypersensitivity. I missed a second day of work, sleeping until 10am that day. Symptoms had subsided upon waking .
67 2021-01-28 nervousness Day of vaccine. Bright red flushing throughout my body. Looked like sunburn. Lightheaded, very tired... Read more
Day of vaccine. Bright red flushing throughout my body. Looked like sunburn. Lightheaded, very tired, headache and feeling shaky. My arm was swollen and redness act injection site Day 2. Low grade fever. Very tired. Achiness. swollen arm. Redness at injection site. Slight headache. Day 3. No fever. Some tiredness. Arm still swollen and tender. Still redness at injection site.
67 2021-01-29 feeling abnormal Evening of 1/28, one week after first dose vaccine, left arm began itching below the injection site.... Read more
Evening of 1/28, one week after first dose vaccine, left arm began itching below the injection site. It itched during the night and upon rubbing it, I felt a lump. The morning of 1/29, arm was red, rash, hot, itch, lump, and this is approximately 2-3' below the injection site - interestingly around my small pox vaccination scar. By mid-afternoon, all symptoms were worse and I did not feel "right" and felt lethargic. I contacted by phone my PCP office and sent pictures. They said "delayed inflammatory response" to injection. I took Aleve and Benadryl at bedtime and it is better today but certainly not gone. ** I did not receive the V-Safe text yesterday to report this. **
67 2021-02-02 anxiety, sleep disorder It's a week after I received my first dose, my left outer arm below the injection site has a red ova... Read more
It's a week after I received my first dose, my left outer arm below the injection site has a red oval swelling that is about 2 1/2 inches long and 2 inches wide with a faint red narrow tail of about two inches extending down my arm. The swollen area is warmer than the rest of my arm. My arm started bothering me last night when I was sleeping; it woke me, just felt funny. When it nagged at me today I scratched and then thought to look at my arm. I noticed I had scratched a few times before because the scratch marks had scabs. My arm doesn't hurt though and it does not affect my regular activities. I was anxious because I did not know if it would lead to more swelling. Now I have read about "COVID arm" so I will stop worrying. Thank you.
67 2021-02-02 feeling abnormal feeling foggy, woozy, a little dizzy and nauseated, racing hearthard to swallow
67 2021-02-04 sensation of foreign body 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 2021-02-04 sleep disorder It started with my arm hurting, even my fingers on the left arm. Then my temperature began to climb ... Read more
It started with my arm hurting, even my fingers on the left arm. Then my temperature began to climb to 101.7 within 20 minutes, accompanied by chills. I was very cold--freezing hands and feet. Could not get warm. Then headache started. Migraine intensity no matter what position I assumed. My joints began to hurt, every joint --knees, elbows, back, even fingers-- so it was difficult walking or moving. Even my teeth hurt where I had had dental work the precious day. All I could do safely was lie in bed with many pillows to hold my head up. I was also nauseous, and a bad case of post nasal drip developed. I could not rest properly all night--I took one baby tylenol every four hours (my usual dose) but it did not help. Finally at 8:00 AM the fever began to subside slowly till to 98.7 and the head ached/ joint pains are slowly dissolving while I am writing this. I normally don't run fever and the last time I had the flue was 40 years ago! I have never been this sick in my life.
67 2021-02-07 anxiety 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 confusional state Restless legs; blurry vision; headache; nausea; lots of confusion; dizzy; metallic taste in mouth
67 2021-02-07 feeling abnormal 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 feeling abnormal About 45 minutes after the injection, my face became red, flushed and warm. My lips, tongue and mou... Read more
About 45 minutes after the injection, my face became red, flushed and warm. My lips, tongue and mouth began tingling. I felt a little strange bur no other side affects. I took a Benadryl and all symptoms were gone in about 15 minutes. Then I felt fine.
67 2021-02-07 excessive sleepiness Chills, body aches and fatigue. went to bed that night slept for 12 hours, woke up the next morning ... Read more
Chills, body aches and fatigue. went to bed that night slept for 12 hours, woke up the next morning and felt fine.
67 2021-02-09 confusional state, loss of personal independence in daily activities, sleep disorder Fever, deep chills, shakes, muscle aches over my entire body, even my hair hurts, a slight dry cough... Read more
Fever, deep chills, shakes, muscle aches over my entire body, even my hair hurts, a slight dry cough. Very extreme fatigue and I am not able to sleep well which is causing me to be really tired. This started as a pain in my arm couple of hours after vaccination and by the next morning all these symptoms started. These symptoms are causing me to not be able to function. She has no appetite. I have spoke to our doctor on the phone Monday evening 02/08/2021, our doctor said to drink fluids and take ibuprofen and it will probably go away. My wife is confused.
67 2021-02-09 insomnia TWO SIDE EFFECTS: 1) I'VE HAD A RINGING IN MY EARS SINCE THE NIGHT OF THE VACCINE...MAKING IT DIFFIC... Read more
TWO SIDE EFFECTS: 1) I'VE HAD A RINGING IN MY EARS SINCE THE NIGHT OF THE VACCINE...MAKING IT DIFFICULT TO SLEEP 2) THIS MORNING I WAS AWAKENED BY MY ARM ITCHING AT THE INJECTION SITE. IT'S RED, RAISED SLIGHTLY AND WARM TO THE TOUCH. THERE ARE TWO AREAS - ONE IS ABOUT 2" IN DIAMETER AND A SECOND SMALLER AREA ABOUT 3/4" IN DIAMETER ABOUT AN INCH ABOVE THE INJECTION SITE.
67 2021-02-10 feeling abnormal Feeling of being "hot" and "not normal" wasn't really wanting a lot of attention.
67 2021-02-10 feeling abnormal Head and muscle aches, "fuzzy" confused head, blurry vision, extreme fatigue, running nose, irritate... Read more
Head and muscle aches, "fuzzy" confused head, blurry vision, extreme fatigue, running nose, irritated gravely voice, nasal congestion. All of the above started, except the fuzzy head and headache which started within 5 hours of the shot, didn't start until about 36 to 48 hours later. They lasted for 5 days!!! Then they started to slowly subside.
67 2021-02-10 impaired work ability Received the vaccine Feb 5th.3:30 pm Rt Deltoid IM on Feb 8t at round 4:00pm I had a sensation on... Read more
Received the vaccine Feb 5th.3:30 pm Rt Deltoid IM on Feb 8t at round 4:00pm I had a sensation on the inside of of rt knee that something was poking me and was painful. When I saw it it was a rash approx 4 inches in diameter. Took Benadryl and put calamine on it. At 2:30 am I woke up with a full body rash head to toes. Raised white bumps. Again took Benadryl every 5 hours and they went away in 24 hour. On Feb 10 out of the blue started sneezing 10 times in a row and suddenly had a full on cold symptom Watery rt eye, rt sided headache runny nose. I am a vaccinator for the Health Dept and have worked 3 clinics. I worked 2 clinics with only having 1 vaccine on board. Today Feb 11th I am going to get a covid test. I am scheduled to vaccinate people tomorrow but I will cancel because I don't know if I have covid or just a cold. I contacted my health provider but have not heard back from him.
67 2021-02-11 hallucination On 02-10-21 at 6 PM I started having a reaction when both my ears felt plugged and within a short ti... Read more
On 02-10-21 at 6 PM I started having a reaction when both my ears felt plugged and within a short time noted decreased hearing. By 9 PM I also had a severe headache with eye pain and dizziness and started to have chills and fever. The chills and fever lasted during the night even with the use of tylenol and ibuprofen. The highest the fever was 100.6. On 02-11 continued with ear problems, headache and eye pain and dizziness. Also at about 10 AM I thought I had an episode of hallucinating when I saw a man walk into our house. When I asked who he was he disappeared. I have had no more episodes like this. This morning I continue with headache and eye pain, dizziness and ear problems. My left arm at the site is pink about quarter size and itches. The symptoms are less painful than 02-11-21.
67 2021-02-11 sleep disorder A week after receiving injection, my arm became itchy and small hives appeared. The next day, the i... Read more
A week after receiving injection, my arm became itchy and small hives appeared. The next day, the injection site area became red and itchy and began to swell and harden. I put an anti-itch topical ointment on it and ice packed the itchy area. The redness, itchiness and swelling increased the following day and the inflamed red area expanded to over 2.5 inches around. I continued to use ice packs and a topical steroid ointment on it. I took Benadryl at night to sleep since the itchiness made it difficult to get a good night's rest. Today (the 10th day), it is still red, itchy and the inflamed area has grown to 3 inches round. I am itchy and very uncomfortable!
67 2021-02-12 nervousness Patient began to feel unwell during the 15 minute post vaccination observation period. She reported ... Read more
Patient began to feel unwell during the 15 minute post vaccination observation period. She reported feeling "very shaky-like when my blood sugar is going low". Was escorted to EMS area for further evaluation. The EMS evaluation determined the need for further evaluation and squad transported patient for further hospital evaluation.
67 2021-02-13 feeling abnormal, sleep disorder 7 days post vaccination (a Sunday) I felt achey, tired, toxic. I went to bed for a couple of hours. ... Read more
7 days post vaccination (a Sunday) I felt achey, tired, toxic. I went to bed for a couple of hours. That night intense muscular and joint aches woke me from sleep. I got up, took 2 Ibuprofen and was able to fall back to sleep. The next morning, Monday, I was 90% better and by the following day, Tuesday, completely fine. However, I realised it was a reaction to the shot and not an isolated incident when I emerged from a hot shower Tuesday and found a huge bright red blotch covering the entire top of my left arm, around the injection site. The arm was not sore, but it looked seriously inflamed. Note: I did have an initial reaction to the shot; the standard sore arm and body aches for 24 hours right after the injection. The reaction I had a week later was similar but much stronger.
67 2021-02-13 feeling abnormal Within an hour post injection most of my joints were swollen, stiff and painful. This lasted 24 hou... Read more
Within an hour post injection most of my joints were swollen, stiff and painful. This lasted 24 hours. Extreme exhaustion that continues 48 hours later. Low fever, chills, weakness, loss of appetite, brain fog continues 48 later.
67 2021-02-13 sleep disorder Moderna COVID-19 Vaccine EUA - I received my second dose IM in my left arm at 9:16 a.m. on Friday, ... Read more
Moderna COVID-19 Vaccine EUA - I received my second dose IM in my left arm at 9:16 a.m. on Friday, February 12, 2021. Within a couple of hours, I experienced soreness at the vaccination site (as I was expecting based on information provided by Department of Health and Human Services). By about 7:00 p.m. I began experiencing some of the expected side-effects (achy shoulder, arm, neck, ribs, and eyeballs). I took an Aleve (NSAID) for the pain at about 9:00 p.m. I felt a little better in the morning on Saturday, February 13, 2021. I took my second (and last) Aleve at about 7:00 a.m. that same morning and then slept for a few hours longer. By the afternoon on Saturday, February 13, 2021 most of the previously described symptoms had subsided. When I woke up at around 3:00 a.m. on Sunday, February 14 , 2021 I woke up with a painful (pain level 7/10) sore throat (mostly on the R side of my throat ), noticed that I had a small blister on the left side of my lower lip, and had what looks like oral thrush or ?COVID-19 tongue?, (bumpy white patches on the tongue). I slept poorly until about 3:00 p.m. and was still experiencing these 3 oral syptoms at 5:30 p.m. on Sunday, February 14, 2021 (about 56 hours after receiving Moderna dose #2).
67 2021-02-14 feeling abnormal 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 loss of personal independence in daily activities, excessive sleepiness 02/12/2021 11pm. Severe right arm pain. 02/13/2021 awakened at 06am with severe arm pain, headache... Read more
02/12/2021 11pm. Severe right arm pain. 02/13/2021 awakened at 06am with severe arm pain, headache, dizziness, nausea, temp 100.4 Unable to get out of bed for day. Headache increased, intermittent joint pain, sips of water only until 6pm 6oz broth. Max temp was 100.8. Mostly sleeping until 02/14/2021 07am. Arm pain began to resolve. Moderate headache, joint pain and lethargy continued all day. Max temp 99.2 Nausea was resolved. 12/15/2021 07am mild headache & arm pain continued but essentially well.
67 2021-02-16 confusional state Neck pain and stiffness, headache unlike any previous headache, fever, myalgia, somnolence, mental c... Read more
Neck pain and stiffness, headache unlike any previous headache, fever, myalgia, somnolence, mental confusion, anorexia, eye pain, photophobia: worst during the first 24 hours after vaccination, but ongoing to present. Feels like meningitis symptoms.
67 2021-02-16 feeling abnormal Fatigue started about 12 hours after 2d dose. About 13 to 14 hrs in, I felt chilled, then feverish, ... Read more
Fatigue started about 12 hours after 2d dose. About 13 to 14 hrs in, I felt chilled, then feverish, then intense nausea. The fever lasted about 24 hrs and went down slowly from over 100 to 98, while the nausea lasted only 2 or so hrs. No vomiting. Slept all day long and was fatigued. About 24 hrs after the symptoms began, I felt fine. Perhaps the fatigue lasted into the next morning as did the fogginess, but I was all better within 48 hrs from the dose.
67 2021-02-16 insomnia After making my PCP aware of my allergies and got the ok I got a shot a covid - 19 shot. I made pers... Read more
After making my PCP aware of my allergies and got the ok I got a shot a covid - 19 shot. I made person who administered the shot that I had allergies and that it was best to stay for 30 minutes. The people at this facility were great and I left at 4:40.( no symptoms ) My arm was tender Sunday night but I didn't think anything of it. The next morning it was very sore and sleeping was difficult but I really didn't investigate till Tues 10AM when I felt a lump on the injection sight. ( It was 12 straight days of freezing temps so I was bundled up)) I called my PCP and spoke with and was not happy with the response that this happens a lot and nothing to worry about. (Covid - Arm 2% / 9% ) I read up on adverse effects and what to do on the internet and started an ice pack, and took an IBprophine and a Benadryl. Which Dr concurred per MyChart after viewing the picture of the injection site I sent her. So its day 3 and I will continue observation.
67 2021-02-16 loss of personal independence in daily activities I had chills, fever, headache, pain in lungs, cough, pain in abdoman, pain in intestines, vomiting, ... Read more
I had chills, fever, headache, pain in lungs, cough, pain in abdoman, pain in intestines, vomiting, weak. had to be in bed 8 days
67 2021-02-17 nervousness 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 sleep disorder 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 sleep disorder About 6 hours after my second COVID vaccination, I started experiencing muscle and joint pain throug... Read more
About 6 hours after my second COVID vaccination, I started experiencing muscle and joint pain throughout my body that was severe enough that I didn't get much sleep. After breakfast, I took 3 Ibuprofen, which somewhat relieved the pain, which I would categorize as about 7 on a scale of 1-10. The pain continued and was uncomfortable but did not require medical attention. At midnight (36 hours after vaccination), I woke up and the pain was all gone. However, the next day (Monday 02-15-2021), I developed a rash and itching on the front side of my left arm (the injection was in the back at the top) that continued for a week, turning into a bruise about 4 inches above my elbow. It doesn't itch any more and the bruise is going away. I am reporting this adverse event to contribute to the knowledge base about reactions to this novel virus and these newly developed vaccines.
67 2021-02-20 feeling abnormal Patient states approx. 3 or 4 hours after vaccine administration she became extremely tired, weak, d... Read more
Patient states approx. 3 or 4 hours after vaccine administration she became extremely tired, weak, dizzy, light-headed and described as "foggy brain". States she had a severe headache for days. States injection site was enlarged to grapefruit size with red, hard and painful area. Symptoms lasted approximately a week. All resolved.
67 2021-02-20 feeling abnormal At 10 am took 1 Benedryl caplet. Had Vaccine at 10:30am. At 11:30am mouth and throat very dry.Drank ... Read more
At 10 am took 1 Benedryl caplet. Had Vaccine at 10:30am. At 11:30am mouth and throat very dry.Drank water then felt throat starting to tighten and took 1 more Benedryl. A little bit later felt drowsy and somewhat dazed. Approx 12:30 pm got a severe headache and neck pain. At 2:30 pm the pain abruptly disappeared without me taking anything for it. Very sore arm was the only effect left. Still sore after 2 days.
67 2021-02-20 insomnia Chills, 101 temp, extreme fatigue but unable to sleep, chills, sweating, gas, bloated stomach, extre... Read more
Chills, 101 temp, extreme fatigue but unable to sleep, chills, sweating, gas, bloated stomach, extreme headache - redness, heat itching at injection site - redness on injection sight move from 1.34 ? to 4? length in 48 hours
67 2021-02-20 insomnia below the site of injection on my left arm I have experienced swelling, redness, pain, warm and tend... Read more
below the site of injection on my left arm I have experienced swelling, redness, pain, warm and tender to touch. Started 2/10 the evening I received the vaccine very light systems, next day 2/11 it was worse and uncomfortable to sleep on the left arm that night. Day three 2/12 the spot had reduced in size and the pain, other than soreness when touched, had lessened. On 2/17 the spot enlarged, redness increased and the pain and heat returned. As of today 2/21 I am still having they symptoms.
67 2021-02-21 insomnia no pain at injection stie; however very severe chills began 12 hours after vaccine, temperature 99.1... Read more
no pain at injection stie; however very severe chills began 12 hours after vaccine, temperature 99.1, brutal joint pain (wrists, hips, knees, ankles, burning & stinging sensation in around nerves and muscles, mild nausea/headache, no sleep for 24 hours. symptoms improved after 48 hours; mild chills, joint/muscle/nerve pain (however, i had some of these symptoms from the chemotherapy and they are now back to that level) i tried to forego pain relievers, but i had to take 2 advil and 2 benadryl 16 hours after the vaccine (around midnight) and took 2 more of each about 12 hours later. drank lots of lemon water to stay rehydrated. normal appetite.
67 2021-02-21 insomnia 2/15/21 evening, Pain down both legs, Skin feels electrified, hurts and is sensitive. Pain in lower... Read more
2/15/21 evening, Pain down both legs, Skin feels electrified, hurts and is sensitive. Pain in lower belly & back. Fatigue 2/16/21 Pain legs, joint pain in knees, ankles & hips all day, Fatigue 2/17/21 Arthralgia & Myalgia all over, but mostly legs, and insomnia, Fatigue 2/18/21 - 2/19/21 - fatigue 2/20/21 - Nausea, no appetite, RASH on lower back, left to middle and down hip and leg and groin area (no itch), no fever, but hot and cold
67 2021-02-21 sleep disorder Pain and tenderness in arm (wakes me up at night when I roll over) Fatigue, mild headache, achy all ... Read more
Pain and tenderness in arm (wakes me up at night when I roll over) Fatigue, mild headache, achy all over, chills, joint pain, some nausea
67 2021-02-23 feeling abnormal Body aches, Eye pain, brain fog, fatigue, headache
67 2021-02-23 feeling abnormal Arm soreness. Muscle aches. Fatigue. Cognitive fog Backache. Lasting 5 days. Cognitive fog and ba... Read more
Arm soreness. Muscle aches. Fatigue. Cognitive fog Backache. Lasting 5 days. Cognitive fog and backache still there after 8 days, improving but not totally gone. Muscle aches still present but improving.
67 2021-02-24 anxiety 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 crying Covid Arm Redness, itching, swelling & weeping around the injection site. Started approx 1 month aft... Read more
Covid Arm Redness, itching, swelling & weeping around the injection site. Started approx 1 month after vaccination.
67 2021-02-24 feeling abnormal After Injection: Day 1 Foggy and Tried Day 2 Sunday - I woke with both my knees hurting very badly... Read more
After Injection: Day 1 Foggy and Tried Day 2 Sunday - I woke with both my knees hurting very badly - took Tylinol put on Ice and heat on both knees front & back elevated Day 3 Monday - Bad night of pain Still very painful took Tramdol and Iced - Elevated Day 4 Tuesday - Painful - Could not bend legs couldn't walk - Very Painful & Knees Swollen Called 911 and went to ER (to no relief) given a pain keller x-rays of knees (Fine) Went Home and could barely walk - still Pain Day 5 Still in pain - Called Osteopatic Doctor and will see him next week Knees need drained according to ER? Using a cain to walk! Still Pain.
67 2021-02-24 sleep disorder 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 2021-02-25 disorientation, feeling abnormal sore arm, light headed, ringing in head, brain fog, disoriented, low energy
67 2021-02-25 feeling abnormal 02/19/2021: slight rash over her chest and arm of immunization site. 02/20/2021: around 5:30 pm, e... Read more
02/19/2021: slight rash over her chest and arm of immunization site. 02/20/2021: around 5:30 pm, entire body started itching, to Benedryl around 7:30 pm and subsided 02/22/2021: Mild itching at site of injection 02/25/2021: Raised rash around 5:30 pm at site of injection, applied cortisone to the injection site 02/26/2021: today early afternoon, started "felt off", chills, noticed hives on neck, chest, upper abdomen, both arms and her back but these do not itch
67 2021-02-25 insomnia Moderna COVID-19 Vaccine EUA (None on first vaccine) 2nd vaccine: chills (could hardly get warm eno... Read more
Moderna COVID-19 Vaccine EUA (None on first vaccine) 2nd vaccine: chills (could hardly get warm enough to sleep). Achy (especially in areas already sore from a workout. Felt double the ache) Wimpy Red and slightly swollen at injection site
67 2021-02-25 sleep disorder Beginning at 10:40 pm: Chills, fever as high as 101.7 orally, headache, very sore injection site, se... Read more
Beginning at 10:40 pm: Chills, fever as high as 101.7 orally, headache, very sore injection site, severe body aches, nausea but no vomiting In bed all day. Can't sleep more than 20-30 minutes. Just got up to sit up and complete this form. Going back to bed. Took 1 Excedrin migraine at 3:00 am. No other medication. I have never had a reaction to another vaccine and I have had many. Scheduled for second injection 3/25/2021 and worried about getting it now!
67 2021-02-26 fear one hour after injection, became very groggy, sleepy, could barely make it home, half hour driving. ... Read more
one hour after injection, became very groggy, sleepy, could barely make it home, half hour driving. Went in slept rest of the day. That night ran fever of 103 pain all through body, chills, couldn't warm up. couldn't eat, just drank water Respiration quick and short. Scary all night long.. Next day fever of 102 aching, bone pain, extreme soreness in arm, couldn't walk without falling.. Stayed in bed, did not eat, no appetite. Third day fever broke somewhat in night. Sweating, fever down to 101, still weak and uncoordinated. Still short of breath just walking. I had a bad case of Covid-19 in July of 2020 and asked if this would aggravate it. Was told no. It actually felt like I had a case of it again. The pain has been really awful. I still do no want to eat on the third day. Still having chills.
67 2021-02-26 sleep disorder THIS WAS SECOND DOSE. GOT ALL SIDE EFFECTS: FEVER, CHILLS, HEADACHE, WEAKNESS, UPSET STOMACH,... STA... Read more
THIS WAS SECOND DOSE. GOT ALL SIDE EFFECTS: FEVER, CHILLS, HEADACHE, WEAKNESS, UPSET STOMACH,... STARTING ABOUT 10 Hrs. AFTER VACCINATION. WAS NOT ABLE TO SLEEP AT ALL THROUGHOUT THE NIGHT IMMEDIATELY AFTER VACCINATION. SIDE EFFECTS LASTED ABOUT 1 1/2 DAYS. NO NOTICEABLE SIDE EFFECTS ON FIRST DOSE GIVEN 1-28-21.
67 2021-02-26 sleep disorder In addition to recognized side effects, approximately 24 hours after injection, I experienced sudden... Read more
In addition to recognized side effects, approximately 24 hours after injection, I experienced sudden-onset severe pain in my right shoulder that traveled through my biceps and into my elbow. On a scale of 1-10, I?d rate the severity as a 10. This lasted approximately 15 minutes. Over the ensuing 5 days I had noticeable but tolerable intermittent right arm pain. Then beginning on the 10th day following injection, I experienced sudden and severe right shoulder pain that traveled down my biceps into my elbow again. I'd rate the pain at a 9 on the same scale. This time however, the pain started around 11 pm and did not subside. I tried sleeping but couldn?t. I got up and spent the rest of the night holding my arm to immobilize it, however that did nothing to stop the pain. It was about 5 am when I finally took 50 mg diclofenac and in about 2 hours the pain subsided to a tolerable 4 on the same pain scale. As the day wore on, the pain increased again to a level 9 without medication so I continued with 50 mg diclofenac every 8 hours over the following 4 days and knocked it back to a level 3. This pain has occurred in my right shoulder, biceps, elbow, forearm and even my fingers and intensifies toward evening. I have been able to tolerate the pain without medication at about a level 3 for the past 2 days. However, I take a 50 mg tab of diclofenac an hour or 2 before bed as the pain intensifies toward evening. This has allowed me to sleep through the night. In addition to the arm pain I developed muscle weakness in my right biceps about 3 days ago and am unable to lift my right arm above my head. The pain is not what prevents the movement. It?s as though my arm is not receiving the nerve impulse to move. Taking all of this together, I?d say that immunization appears to have triggered Parsonage Turner Syndrome. As I understand this immune-mediated syndrome, several events can trigger it, including immunization. I experienced this phenomenon one other time, approximately 2 years ago but did not correlate it to a vaccination at the time. This time it?s too apparent. I wonder how many other reports you?ve received that are like this and whether the vaccines will trigger the same reactions. I also wonder now whether I should receive a Moderna ?booster? if needed in the near to long term. I have no interest in going through this event a
67 2021-02-27 feeling abnormal I awakened 3 times that night after my injection to get up and urinate in the toilet. (Normally, I ... Read more
I awakened 3 times that night after my injection to get up and urinate in the toilet. (Normally, I only awaken once or twice a week and then it's only once per night). The third time I felt a little 'foggy', but I went back to sleep. I woke up ~8:30 am and got up to take my shower. While brushing my teeth, I felt like I was going to faint. I made it back to my bed (~10 feet away) just in time, threw myself on the bed and stayed there ~ 4 more hours. I drank water often during that time (that my husband brought the water to me. At ~1:00 pm I felt strong enough to go downstairs. I was okay the rest of the day, just tired. The next morning I felt 100%.
67 2021-02-28 feeling abnormal I started to get cold/chills about 10:00 p.m. by 12:00/midnight I had uncontrollable chills and sh... Read more
I started to get cold/chills about 10:00 p.m. by 12:00/midnight I had uncontrollable chills and shivers (I've never been so cold in my life. I felt like my bones were going to break). At 1:00 a.m. my arm started to hurt and then throb. At injection area Simultaneously I started to get a headache and the pain and discomfort traveled down my entire body/shoulders-arms-HANDS (ached terribly)-chest-legs-feet At 4:00 a.m. everything all subsided and I was able to sleep 'til 7:30 a.m. On Saturday I took a 2 hr. nap n the afternoon and went to bed at 7 p.m. and slept for 11 hrs. Felt winded all day Sunday and joints ached Monday, still easily winded
67 2021-02-28 nervousness, impaired work ability, crying, disturbance in attention 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 2021-03-02 impaired work ability Moderna COVID-19 Vaccine EUA -- Arm not sore at all on 3/1/2021. Next morning 3/2/2021 right de... Read more
Moderna COVID-19 Vaccine EUA -- Arm not sore at all on 3/1/2021. Next morning 3/2/2021 right deltoid was sore, and got more sore as day went on. Nausea, fatigue and low fever 99.5 (normal temp 96.8-97.6 degrees) afternoon starting at noon . Took Ibuprofen 400 mg and Tylenol 1000 mg at 3:30 p.m. and 200 mg Ibuprofen and 500 Tylenol at 9:00 p.m. 3/3/2021 - 7:30 am fatigue Body aches esp right hip. Right deltoid Injection site much less sore on 3/3/21. Took Ipubrofen 400 mg on 3/3/2021. Symptoms were similar to a mild case of Covid 19 which I experienced in July 2020. I had to stop work at 3:30 p.m. on 3/2/2021 and stayed home due to fatigue on 3/3/2021. Symptoms improving on 3/3/2021 at the time of filling out this form.
67 2021-03-03 feeling abnormal Extreme fatigue, moderate to severe headache, nausea, lower back pain, over all muscle ache, foggy ... Read more
Extreme fatigue, moderate to severe headache, nausea, lower back pain, over all muscle ache, foggy cognition. Felt like I had an extreme case of the flu. Next day (today), my symptoms have resolved approximately 95%. Fatigue and arm soreness, slightly remain.
67 2021-03-03 sleep disorder Same night vaccination received pain to lower back, waist level, both sides and also to both hips. u... Read more
Same night vaccination received pain to lower back, waist level, both sides and also to both hips. unable to sleep or get comfortable to return to sleep. Pain persisted to lower back and both hips for several days. Took Ibuprofen 600mg 3 times a day but did not last during the night. Pain would wake me up. After several days pain moved to just left hip and radiated down the back of my leg to the knee the radiated to lateral calf. On Monday 3/1/21 went to my PCP because the pain was not improving and at night it woke me and I was awake for several hours. Walking didnot increase the pain but sitting would. My PCP felt it was related to my Covid Vaccination. She changed my NSAID to voltarin 2 times a day, because the ibuprofen was not long lasting and she started a muscle relaxer for night time, Tizanidine 4mg. I don't feel the voltarin is as effective as the ibuprofen as the ibuprofen resolved the pain but for only 4-5 hrs. I will stop tthe voltarin and return to the ibuprofen. Muscle relaxer is helpful.
67 2021-03-03 sleep disorder I received the vaccine around 10:30AM. Around 4:00PM that day I started having severe dizziness. Abo... Read more
I received the vaccine around 10:30AM. Around 4:00PM that day I started having severe dizziness. About 40 minutes later I had severe pain in my neck, back, and shoulders. I have had 3 herniated discs in the past and the pain from this was much worse than that pain. About the same time I felt a headache coming on that just got worse as the night went on. I decided to go to bed and try to sleep, however, the pain was so great that I could not lay down flat or sit up. I spent the night walking the floor. During the night I vomited several times. I also developed jaw pain, earaches, and a sore throat. But the worse part was that during the night I started to feel the sensation of pins and needles being thrust into my legs, ankles, arms, and hands. I never did however have a fever. I finally was able to fall asleep at about 5AM and slept for several hours. When I woke up the pain was mostly gone and I was just left with no energy at all so that I could hardly lift my head off the pillow. I stayed in bed the entire day and the next day I was fine.
67 2021-03-04 delirium, amnesia, confusional state Pt reported the day after her vaccine, 3-2, she was delirious and did not remember that day. She wen... Read more
Pt reported the day after her vaccine, 3-2, she was delirious and did not remember that day. She went to bed and slept most of the day. On 3-3 she woke up with a red rash on her trunk and extremities. The rash did not itch and was not painful. She took Benadryl and on 3-4 the rash was fading. Spoke with husband to get more info on 3-2 since patient did not remember. Husband stated that patient woke up slurring words, not completing sentences and repeating herself. Husband put patient back to bed and she continued to sleep for most of the day. Husband called PCP and they recommended her to go to the hospital but they did not. Husband states on 3-3 patient was back to normal except for the rash. Husband also stated that the patient has had this happen before, the slurring of the words, and confusion. They did not call and report to the neurologist. Recommended to call and go over this reaction with the neurologist and get the ok for the second dose and will need to provide a letter.
67 2021-03-04 restlessness Started Wed. the 17th with headache and neck stiffness ---Arm sore Then proceeded to bedrest and h... Read more
Started Wed. the 17th with headache and neck stiffness ---Arm sore Then proceeded to bedrest and had very bad chills and continued headache. Restless night and on the 18th, was tired and rested the full day
67 2021-03-04 sleep disorder severe pain in arm radiating up and down-wakes me up at night not sleeping much
67 2021-03-05 feeling abnormal Sore shoulder, arm. Swollen lymph node in same arm. Mental fog. Extreme tireness.
67 2021-03-06 confusional state 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 2021-03-07 confusional state COVID symptoms that lasted about 18 hours (cough; tired; chills; confusion)
67 2021-03-07 sleep disorder Arm pain and rash at injection site, tremors, very cold, fever, joint and body aches, no appetite, d... Read more
Arm pain and rash at injection site, tremors, very cold, fever, joint and body aches, no appetite, diarrhea sleep, extra strength Tylenol, fluids , rice 4 days before all symptoms subsided
67 2021-03-07 sleep disorder After 1st dose on 3/1 and arm was sore and two day later Wednesday I started having issues, bad burn... Read more
After 1st dose on 3/1 and arm was sore and two day later Wednesday I started having issues, bad burning sensation inside and couldn't lay on it, I developed a rash on body and face. Everything that started happening happened on the same side as the vaccine I received. I am being treated for Shingles because all the symptoms are like Shingles, but it's on the inside
67 2021-03-08 disturbance in attention, mental impairment, loss of personal independence in daily activities About 20 hours after the shot, I was exhausted, and had a headache. I could not function or think c... Read more
About 20 hours after the shot, I was exhausted, and had a headache. I could not function or think clearly. My head really hurt. Temp 97.3 By the next morning, the headache had lifted but the fatigue remained for another day. That day, I made several significant errors when copying email addresses and forwarding email info to group members. Fast forward to March 6. Very tired and hard to focus. Felt worse on March 7 but kept pushing myself. March 8, I couldn't function and sat in a chair a lot of the day. My head hurt and I noticed a red hard and hot area over the injection site. My temperature was elevated to 98.8 which for me is 1.5 to 2 degrees elevation. Then it all made sense. Today, March 9, I'm feeling better, but very tentative about how much to do. At least well enough to fill out this form. I can think clearly and I am able to function.
67 2021-03-08 fear Headache, body aches, and fever for 24 hours. Fatigue the following 24 hours.
67 2021-03-08 feeling abnormal Slight light headedness right after vaccine during 15 minutes wait period. Next day (the 5th) headac... Read more
Slight light headedness right after vaccine during 15 minutes wait period. Next day (the 5th) headache & extreme fatigue--felt "drugged" when I woke up. Evening of next day (5th) chills, continued fatigue. On the 6th still very tired, still some chills. On 7th still tired.
67 2021-03-08 feeling abnormal Headaches, sore arm, rash, shot site itches, fever, upset stomach, abdominal pain on lower left side... Read more
Headaches, sore arm, rash, shot site itches, fever, upset stomach, abdominal pain on lower left side off and on, feel off, lethargic and loss of appetite.
67 2021-03-08 nervousness 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 sleep disorder 5 hours after vaccine I began to feel as if a RA flare was beginning. I was totally exhausted, join... Read more
5 hours after vaccine I began to feel as if a RA flare was beginning. I was totally exhausted, joints in my hands began to swell and so painful that I needed to wrap them in heating pad. It was painful just lifting a cup of tea. By the time I went to bed my neck was also hurting. Woke several times due to pain. By morning I just feel drained and want to rest. Site of injection is sore but nothing bad. I wish I had known this would be causing such a severe RA reaction. I doubt if I will be getting the 2nd dose.
67 2021-03-09 anxiety Progress Notes Expand AllCollapse All COVID VACCINE CLINIC 2/10/2021 Subjective PT. is a 67 y.o... Read more
Progress Notes Expand AllCollapse All COVID VACCINE CLINIC 2/10/2021 Subjective PT. is a 67 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Moderna vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and neck pain. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, hypotension, rapid progression of symptoms, respiratory distress and tongue swelling. Medical history includes htn, hld. Takes low dose 10 mg po daily Lisinopril. Last ov with pcp in October, bp normotensive. Review of Systems Constitutional: Negative for chills, diaphoresis, fatigue and fever. HENT: Negative for drooling, facial swelling, sore throat and trouble swallowing. Eyes: Negative for itching. Respiratory: Negative for cough, choking, chest tightness, shortness of breath, wheezing and stridor. Cardiovascular: Negative for chest pain and palpitations. Gastrointestinal: Negative for abdominal pain, nausea and vomiting. Musculoskeletal: Positive for myalgias (neck/upper shoulder pain). Skin: Negative for color change, pallor and rash. Neurological: Positive for headaches (pressure behind eyes). Negative for dizziness, syncope, facial asymmetry, speech difficulty, weakness and light-headedness. Psychiatric/Behavioral: Negative for agitation and confusion. The patient is not nervous/anxious. Previous Reactions: none Objective Vitals Vitals: 02/10/21 1108 02/10/21 1111 02/10/21 1153 BP: (!) 199/96 (!) 164/103 (!) 162/80 Pulse: 90 84 74 SpO2: 97% 96% Blood Sugar 99 collected at 1111 Blood Sugar 99 collected at 1145 Physical Exam Vitals reviewed. Constitutional: General: She is not in acute distress. Appearance: She is not ill-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds and air entry. Musculoskeletal: Cervical back: No swelling. Comments: ttp over upper trapezius. No cervical spine tenderness. Skin: General: Skin is warm. Coloration: Skin is not pale. Findings: No rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water, snacks and tylenol Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Directed to closely follow up with her primary care provider on her blood pressure. She's aware of what to watch for and when to go to ED. Pt denied wheelchair. She was accompanied out to front assistant. Dr. at bedside as well. Electronically Signed 2/10/2021 11:54 AM
67 2021-03-09 feeling abnormal I became warm and flushed all over a few minutes after shot , then foggy feeling with congestion in... Read more
I became warm and flushed all over a few minutes after shot , then foggy feeling with congestion in sinus. I waited about 20 minutes and left I spoke to my allergist and he said that I had experienced mild anaphylaxis and should not take dose 2 of the vaccine
67 2021-03-09 loss of personal independence in daily activities 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 sleep disorder About 5 hours after my shot my left arm began hurting way worse than after a flu shot. I have barely... Read more
About 5 hours after my shot my left arm began hurting way worse than after a flu shot. I have barely slept Sat, Sunday, Monday or Tuesday night because of the intense pain. I couldn't raise my are at all until yesterday I could slowly raise from my elbow to my hand. Today, 3-10 I can finally raise the upper part of my arm very slowly with some pain. It still hurts constantly but is getting better than it had been. I just can't sleep because of the pain. I have taken muscle relaxers, tylenol and ibuprofen but nothing helps.
67 2021-03-09 sleep disorder Moderna COVID-19 Vaccine EUA Received vaccine at 9am. By 1pm extreme fatigue and pain in back of nec... Read more
Moderna COVID-19 Vaccine EUA Received vaccine at 9am. By 1pm extreme fatigue and pain in back of neck. Some muscle pain at site of vaccine. Then at 8pm high fever (99.5 - very high for me - I always record low temps.) Severe joint and muscle aches. Sweating. Couldn't sleep. Muscle weakness. Nausea, vomiting at about 2am. Severe pain at vaccination site. All continued until about 5am, when I finally slept for a couple of hours. Today, 10am on the 10th - pain at vaccine site, extreme fatigue and exhaustion. Just a terrible, terrible night.
67 2021-03-09 sleep disorder chills, headache, aches, fatigue ... soreness @ injection site. These symptoms began at 3 AM so Wen... Read more
chills, headache, aches, fatigue ... soreness @ injection site. These symptoms began at 3 AM so Went back to bed and tried to sleep through the night. On Tuesday Mar 9. I continued to have mild headaches and achiness/fatigue during the day., however, began to feel better during the day. Back to normal on Wednesday, March 10. Feeling fine now.
67 2021-03-10 feeling abnormal During the evening (after going to bed) started having chills and body felt "heavy". When awoke the ... Read more
During the evening (after going to bed) started having chills and body felt "heavy". When awoke the next morning felt fine but noticed slight loss of energy and laying down (not necessarily sleeping) felt better than sitting up.
67 2021-03-10 feeling drunk, confusional state 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 sleep disorder Dose #1, 3/2/2021 @ 3:30pm, while getting shot the site bled a lot and lump formed on arm, felt warm... Read more
Dose #1, 3/2/2021 @ 3:30pm, while getting shot the site bled a lot and lump formed on arm, felt warm, after 15 minutes nurse said site looked Ok and didn't feel warm, so I was released. Arm was slightly sore when raising arm or pressing on site. Day 1 after injection, 3/3/2021, bruised at injection site and sore to touch. Day 8 after injection, 3/10/2021, Site area still bruised (yellow/green) that evening, began itching around right outer edge of bruise, applied Lanacane after shower. Day 9 after injection, 3/11/2021, Overnight I didn't sleep well, when I awoke, red bruise where it first itched and below that. Bruise is larger in area and more color to it.
67 2021-03-11 abnormal dreams Severe headache for 28 hours, fever for 24 hours, intense muscle aches for 24 hours. Hallucinatory ... Read more
Severe headache for 28 hours, fever for 24 hours, intense muscle aches for 24 hours. Hallucinatory type dreams or awakening. Never had that before.
67 2021-03-11 feeling abnormal Extreme pain, muscle spasms, could not walk, high temperature, headache for 24 hours, wobbliness and... Read more
Extreme pain, muscle spasms, could not walk, high temperature, headache for 24 hours, wobbliness and difficulty walking, winded, lack of clarity next day
67 2021-03-11 insomnia Aching all over body; headache (extreme) Friday - Saturday; Temp to 100; Shortness of Breath w/ extr... Read more
Aching all over body; headache (extreme) Friday - Saturday; Temp to 100; Shortness of Breath w/ extreme cough; extreme fatigue; sore throat w/ trouble swallowing; cough continued Mon - Wed; sleeplessness; Thursday aches had gone, but continue to experience cough and chest congestion
67 2021-03-11 restlessness Sore arm, chills, nausea, restlessness, lack of appetite most of 03/11/2021. Slept or rested most of... Read more
Sore arm, chills, nausea, restlessness, lack of appetite most of 03/11/2021. Slept or rested most of day. Headache from about 5:00-9:00 at night. I took one Naproxen for the headache. On the positive, I have not had any back pain from my arthritis which I suffer daily.
67 2021-03-11 sleep disorder Jan 14, 2021 1st Dose Moderna COVID19 vac-Rec'd in R-arm. Sore muscle-bearable lasted 4 days. Tiredn... Read more
Jan 14, 2021 1st Dose Moderna COVID19 vac-Rec'd in R-arm. Sore muscle-bearable lasted 4 days. Tiredness lasted 1 day. Vac site swollen, red and itchy-Bearable. Sore muscle and vac site reaction all done by 5th day. Did not take anything for the discomfort. Feb 12, 2021 2nd Dose Moderna COVID19 VAC-Rec'd in R-arm at 1:35p. 1. Feb 12 8:30pm my neck from the base of my skull down to top of my shoulders in pain and muscle spasms severe for a couple of hours. Felt faint until it was over. 2. Feb 12th and 13th The R-arm muscle ached with much pain coupled with soreness all night-no sleep. Did not take anything for this discomfort. No fever during the night. 3. Feb 13th Muscle left with little movement. Felt like it was going to break if I forced it past its abnormal limitation this morning. Took nothing for the muscle pain. Awoke with dull headache left side of head morning of the 13th. Fever of 99.1. My normal is 97.7. Took nothing for the fever. 4. Fever all day until approximately 6pm. Fluctuated all day long between 99.1 and 100.2; never going lower or higher. Fever broke on its own approx 6pm. 5. Feb 14 No Fever. Felt pretty good. No headache; muscle still very tight and sore but still working with it. Tiredness but went about my daily activities. Took nothing for the muscle pain. 6. Feb 15 No Fever. Over did it on the 14th. Did nothing all day. This is the day the injection site became very swollen red and extremely itchy. Started ice cold compresses to relieve that irritating itch. This reaction lasted thru day 7. By day 8 the extreme itchy and swelling was gone. First day to bed by 7pm. Slept all night until 5am. 7. Feb 16 Day 4 after vac. No fever. I picked up my activity slightly from the day before. Tired. To bed again at 7p. Slept until 5:40am. 8. Feb 17 Day 5 after vac. No fever. Felt real good. Energetic! Had pretty much a normal day yet careful to not over do. 9. Feb 18 & 19 Days 6 & 7 after vaccine. HORRIBLE. Woke up with a splitting headache both days! No fever! The following happened all on the left side of my head and face. a. Left eye left corner painful. No twitching. Tight. b. Left side of face on cheek above where my mandible has been deteriorating since 2016 with associated bone infection that has been subsided since Dec 9, 2020 a blemish appeared. Not a pimple. But a blemish that had opened sometime during the night bled a little and had scabbed over. There was nothing there before I went to bed. c. A BLISTER had formed on top of the left side of my scalp. It was extremely sore. 10. Feb 20 Day 8 after receiving vaccine EVERYTHING was gone as though nothing happened, the splitting 2 day headache, the 2 day painful left eye, and the 2 day painful blister on my scalp. The blemish on my cheek was clear in 3 days from appearing on Feb 18th. Please note that I had not taken any medicine to alleviate any of these side effects. I allowed it to run its course. Also, the last 2 days of side effects beginning on the 18th and 19th were so severe (to me) I felt compelled to report my side effects. End of side effect reporting.
67 2021-03-11 sleep disorder None with first shot. Just tender arm at injection site. After the noonday second shot 2/25/2021 ,... Read more
None with first shot. Just tender arm at injection site. After the noonday second shot 2/25/2021 , within 24 hrs. I was awaken with ringing in my ears which still continues today.
67 2021-03-12 disorientation Extreme fatigue, severe weakness( in bed for 2 days) dizziness, disoriented, nausea, severe heada... Read more
Extreme fatigue, severe weakness( in bed for 2 days) dizziness, disoriented, nausea, severe headache. injection site swollen(egg size) hot for 4 days(applied ice, and took Tylenol ) Adverse reaction has lasted 3 days, still feeling disoriented day 4 .
67 2021-03-12 insomnia Severe injection site pain immediate onset. MOderate insomnia night of 17 Febraury 2021
67 2021-03-12 loss of personal independence in daily activities Started to be a little achy about 4 hours after receiving second vaccine (~9 pm) so went to bed. I... Read more
Started to be a little achy about 4 hours after receiving second vaccine (~9 pm) so went to bed. I woke at 5:30 a.m. with a pounding headache and aching joints. My joints all hurt. My legs and arms feel like they are on fire. I am very tired which is a blessing because I have slept for most of the day. I have had chills and sweating off and on, going from cold to hot. I am somewhat nauseated. I have taken four Ibuprofen so far. I continue to drink clear liquids, mostly water. I am eating very lightly and sleeping. I have cancelled all activities.
67 2021-03-12 mental impairment 1. General malaise followed by numbness around nose and lips. Took Benadryl 1.5 hours after vaccin... Read more
1. General malaise followed by numbness around nose and lips. Took Benadryl 1.5 hours after vaccine do to worsening of numbness. 2. The following day flare in joint areas of arthritis. 3. Out break of herpes 2 which had been dormant for three years. Out break has continued since vaccine. 4. Numbness around mouth has persisted since vaccine. 5. Change in ability to process information.
67 2021-03-12 sleep disorder Symptoms tarted about noon the day after my vaccination. Except for arm pain which was immediate. S... Read more
Symptoms tarted about noon the day after my vaccination. Except for arm pain which was immediate. Started feeling warm and weak. quickly advanced to headache, chills, fever that was at one point 102.2. Severe body aches and the headache became severe. Had a couple of painful muscular spasms when trying to sleep. I took melatonin to help me sleep but nothing for the pain as I had heard not to. Severe symptoms lasted for approximately 15 hours. Still weak, achy and have a headache 24 hours later.
67 2021-03-14 feeling abnormal low fever, chills, generally feeling bad and pain in upper left abdoman under rib that was similar t... Read more
low fever, chills, generally feeling bad and pain in upper left abdoman under rib that was similar to kidney stone, intermittent not constant, lasting all night and next day.
67 2021-03-14 feeling abnormal Diahrea. nausea, severe pain at every site I ever had surgery or a procedure. Severe pain in both fe... Read more
Diahrea. nausea, severe pain at every site I ever had surgery or a procedure. Severe pain in both feet, pain in my midsection , pain in my back, pai n in my legs. weakness and tired ness from the day of vaccine in January 24th until around March 10th. I felt like I wanted to die.
67 2021-03-14 feeling abnormal apparently 'COVID ARM' - it is Monday (after a Friday vaccination) and the red rash is still there ... Read more
apparently 'COVID ARM' - it is Monday (after a Friday vaccination) and the red rash is still there (very mild itch) and is located about 2" below the injection site -over the bicep and is about 5" long (pear shaped). Mild soreness around the injection site and warm in rash area but no big deal. I have not taken any over the counter meds with the exception of 1 Tylenol tablet (500mg) on Saturday evening to counter other reactions which occurred about 8 hours after injection (mild headache and medium fatigue, and a 'bit off'). That was gone by Sunday. The only thing that still remains is the tender arm with warm rash. While it doesn't seem to be getting worse, it is not resolving yet.
67 2021-03-14 loss of personal independence in daily activities, incoherent, feeling abnormal, confusional state Incoherent, unstable, difficult to talk, confusion, felt distant (isolation) from others in the room... Read more
Incoherent, unstable, difficult to talk, confusion, felt distant (isolation) from others in the room, weak, dry mouth and throat, queasy. I drove home 1-2 hours later when feeling a little better and had to really focus to get myself home, difficult to recognize the area around me when driving. It was difficult to do anything when arriving home, went to bed. I was better the next morning (today) but my brain is still fogged.
67 2021-03-14 sleep disorder At 12:30 am on Sunday, Feb 28th first sign of reaction was very cold. Couldn't put enough clothes/bl... Read more
At 12:30 am on Sunday, Feb 28th first sign of reaction was very cold. Couldn't put enough clothes/blankets on to keep warm. By 4:00 am I was taking them off because I was so hot. Terrible night sleep (or lack of). Headache, nauseous, felt like I had a stomach virus because was shaky, weak and sweaty, temp on Sunday morning, the 28th, was 100.6. Slept fitfully most of the day. Tried to eat chicken noodle soup about 2:30 pm but threw up at 6:00 pm. On Sunday night, woke up at 2:30 am and recognized my stomach felt fine but still had headache. When I woke up Monday morning between 9 - 10:00 am felt fine but was still weak and shaky. As I ate on Monday, I felt my strength come back and had more energy.
67 2021-03-14 sleep disorder 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 loss of personal independence in daily activities Chills & shivering began around 11:00 pm of the evening of the vaccine day and lasted through the ni... Read more
Chills & shivering began around 11:00 pm of the evening of the vaccine day and lasted through the night and next morning. Very bad headache. Upon rising around 3:00 pm the following afternoon to use the bathroom, feeling very weak, passed out in the bathroom for just a second or two. Felt nauseous. Husband picked me up and put me back in bed. Registered low fever of 99.6. Took 2 Tylenol which seemed to alleviate the headache about 50%. Stayed in bed for balance of day. The Monday following the Saturday of the vaccine, neck was very sore to the touch on both sides underneath my ears. Could not lift head without aid. Remained in bed the balance of the day. Tuesday morning, felt good enough to get out of bed and resume regular activities but still only about 90%.
67 2021-03-16 disturbance in attention dizziness could not focuss room was spinning
67 2021-03-16 feeling abnormal 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 sleep disorder My entire upper left arm and shoulder/neck radiate with pain. I am unable to rotate or flex my arm ... Read more
My entire upper left arm and shoulder/neck radiate with pain. I am unable to rotate or flex my arm without severe and radiant pain. My arm is weak and cannot raise, lift or rotate it above the elbow. Very difficult to maintain sleep with a throbbing arm. I have been taking Alleve and it helps but the pain is still there just milder. Muscles are not sore but something is aching deep in bone/joints. I went to the Kinesiologist who told me the rotor cuff is the issue. He did an pressure point "adjustment" and the pain subsided for a day or two and now I'm back to being in pain during any level of movement again. I believe that my injection was given too high in my shoulder and caused SIRVA. I even took a picture of where the injection site was given. If needed I can provide it to you.
67 2021-03-17 disorientation Received the vaccine, no reactions at all, went shopping all afternoon, and went to bed, woke up at ... Read more
Received the vaccine, no reactions at all, went shopping all afternoon, and went to bed, woke up at 4:00 AM with a super bad headache and a fever. Laid back down in bed, worse headache she has ever had and does get migraines. She did have the size of about an egg with a rash on the arm itself. She was disoriented, had chills and clammy, felt like she wanted to throw up but did not, fatigue. The intense headache lasted until this morning 3/18/21. She took 600 mg of Ibuprofen initially and then 500 mg every 4-6 hours of Tylenol, which helped. The headache is pretty much gone, small fever, able to walk better this afternoon.
67 2021-03-17 feeling abnormal Patient reported that she started feeling bad the night of the vaccination. Patient went to the hosp... Read more
Patient reported that she started feeling bad the night of the vaccination. Patient went to the hospital and was admitted. Patient was told she had COVID-19 and a UTI. She says she was given convalescent plasma for COVID-19. She said she had pneumonia, fever, cough, fever and chills.
67 2021-03-17 feeling abnormal 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 2021-03-17 restlessness, insomnia 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 2021-03-18 anxiety, sleep disorder 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 anxiety 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 poor quality sleep started immediately after injection - 4 days of arm pain, fever, lymph node swelling, headaches, poo... Read more
started immediately after injection - 4 days of arm pain, fever, lymph node swelling, headaches, poor sleep, extreme chills; 3 days later - hot arm rash, fever, lymph node swelling, headaches, poor sleep, chills, body aches - had this for 3-1/2 days; 2 days later got the arm rash with same symptoms again - had this for 3 days.
67 2021-03-20 feeling abnormal slight headache, extreme fatigue, body aches all over, fuzzy brain, couldnt function, no appitite, d... Read more
slight headache, extreme fatigue, body aches all over, fuzzy brain, couldnt function, no appitite, dry mouth, arm hurt where shot wa s done, took tylenol, for two days
67 2021-03-20 insomnia Fever, vomiting, diarrhea, insomnia, sore painful muscles ,chills, headache
67 2021-03-20 loss of personal independence in daily activities vomiting, diarrhea, headache, pain, fever, body aches, flu-like symptoms, Heaviness in legs, could ... Read more
vomiting, diarrhea, headache, pain, fever, body aches, flu-like symptoms, Heaviness in legs, could not raise the left arm, tiredness, slept for 2 days,
67 2021-03-20 sleep disorder Headache began in late afternoon, unwell feeling. Headache in frontal lobe disrupted sleep all nigh... Read more
Headache began in late afternoon, unwell feeling. Headache in frontal lobe disrupted sleep all night. Had fever by morning, highest checked was 101.7. Stayed in bed until noon. Took aspirin later in 15th, fever slowly diminished to about 99 by evening. Stayed in bed all day on 15th. Took a Nyquil to help with sleep on evening of the 15th. Woke up feeling well on the 16th. Had some nasal congestion in evening couple of days, took Dayquil 2 following days. Then all well.
67 2021-03-21 confusional state, feeling abnormal, emotional distress, depressed mood, crying Impaired cognition...fog headed, indecisive, unclear Malaise, lethargy, slept 1 1/2 days Muscular an... Read more
Impaired cognition...fog headed, indecisive, unclear Malaise, lethargy, slept 1 1/2 days Muscular and joint aches and pains, rest Depressed, sad, tearful...cried and slept
67 2021-03-21 feeling abnormal DAY 1 - SWELLING AND DSICOMFORT AT INJECTION SITE - USED ICE AND KEPT MOVING ARM A LITTLE NAUSEA AND... Read more
DAY 1 - SWELLING AND DSICOMFORT AT INJECTION SITE - USED ICE AND KEPT MOVING ARM A LITTLE NAUSEA AND "BLAH" FEELING LIKE AFTER FLU SHOT WHICH WAS EXPECTED AT THE END OF THE DAY NOTICED THAT MY KNEES AND LEGS WERE SWOLLEN WHICH ONLY HAPPENS WHEN I EAT SHELLFISH - THERE WAS NO OTHER PROBLEM - I KEPT MY LEGS ELEVATED AT NIGHT AND SWELLING WAS DOWN A LITTLE IN THE MORNING. DAY 2 CALLED PRIMARY CARE PHYSICIAN (PCP)- WE AGREED IT WAS OK TO TAKE BENADRYL AND IF DIDN'T CLEAR UP I WOULD NEED TO GO INTO HIS OFFICE FOR EVALUATION. BENADRYL STARTED WORKING AFTERNOON OF DAY 2. ALL SWELLING DOWN ON AFTERNOON OF DAY 4 (SATURDAY 3/20). REPORTED BACK TO PCP ON DAY 6 (MONDAY 3/22).
67 2021-03-22 confusional state vertigo, high bp, high pulse, confusion,
67 2021-03-22 excessive sleepiness Soreness in arm Chills, sweating, sleep 28 hours
67 2021-03-22 sleep disorder 1. metallic taste in mouth - 7 days 2. Arm sore at injection site - 4 days 3. Tongue felt swollen-2 ... Read more
1. metallic taste in mouth - 7 days 2. Arm sore at injection site - 4 days 3. Tongue felt swollen-2 days 4. Jaw felt locked--8 days 5. nauseous--20 days 6. diahrreah 2 days a week apart 7. Loose bowels--8 days 8 sharp pain in left ear--4 days 9. vomiting--2 days 10. extremem fatigue--21 days 11. stomach bloated severely--4 days 12. sever headache--8 days, even woke me at 3 am 2 times 13. joints and muscles ache--12 days 14. Chills--4 days; developed a week after the vaccine 15. Extremely stuffy nose and somewhat runny, felt like someone punched me in the face the first 4 days--28 days on and off 16. severe stiff neck--started stared day 14 of vaccine--5 days 17. dizzy and vertigo--started a week after the vaccine, lasted until the Epley Maneuveur done on March 16
67 2021-03-23 anxiety Vaccine #1: extreme fatigue, genital herpes outbreak and mental sensation of euphoria or unnatural h... Read more
Vaccine #1: extreme fatigue, genital herpes outbreak and mental sensation of euphoria or unnatural high. These symptoms lasted for 2 days. Vaccine #2: high fever, nausea, vomiting, severe headache, dizziness. In bed for 2 days with symptoms . Remained fatigued, dizzy and nauseous for about a week. Second week experienced high mental anxiety and a internal sensation of my body vibrating uncontrollably. Third week I experienced burning, aching sensations on my face. My face was bright red with a burning raised rash all over my face but especially on my left cheek. Had a herpes outbreak inside my left cheek a few days after the burning started on my face. Herpes lasted about 7 days. My face still burns and I still have a rash on my left cheek.
67 2021-03-23 feeling abnormal, insomnia Felt extreme fatigue at 3:00 in the afternoon, then by 4:00 bad headache, chills with trembling, mus... Read more
Felt extreme fatigue at 3:00 in the afternoon, then by 4:00 bad headache, chills with trembling, muscle and joint pain , general weakness, and "felt terrible". Slept fitfully, first in recliner then bed, till 8:00 next morning. By 9:00, felt fine.
67 2021-03-23 feeling abnormal 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 2021-03-25 nervousness The patient received her 2nd Moderna COVID vaccine on 3/25/21 at 1:00. At 3:00 she began to feel sha... Read more
The patient received her 2nd Moderna COVID vaccine on 3/25/21 at 1:00. At 3:00 she began to feel shaky and tired. She is still feeling shaky and tired but has taken any medication or gone to the doctor.
67 2021-03-25 nightmare I had diarrhea; and I had a horrible nightmare; I was really tired. Diarrhea symptoms for 5 weeks ( ... Read more
I had diarrhea; and I had a horrible nightmare; I was really tired. Diarrhea symptoms for 5 weeks ( at least one week after the 2nd dose of vaccine). I saw the doctor on the 14th of January. He just told me to drink water.
67 2021-03-27 feeling abnormal 3/26: Headache about 2 hours after administration. and my face turned bright red and hot. 3/26 even... Read more
3/26: Headache about 2 hours after administration. and my face turned bright red and hot. 3/26 evening: I experienced chills, body aches, fever, light chest congestion, fatigue, nausea. Influenza-type symptoms. 3/27: I felt terrible-ran a fever all day of 99.9 - 99.5. 3/28 morning: felt much better.
67 2021-03-27 panic reaction, crying, confusional state 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 2021-03-27 sleep disorder, feeling abnormal I felt funny within an hour of the vaccination. By 1 p.m my lower lip felt tight, when I looked in t... Read more
I felt funny within an hour of the vaccination. By 1 p.m my lower lip felt tight, when I looked in the mirror around 3 p.m. I noticed my lower lip was swollen. My husband says it was swollen and purple. By bedtime, the swelling in the lip had gone down. About 3 am, I was awoken by shivers going through my whole body. My feet and hands were like ice cubes. I curled up and stuck my head under the covers, but keep shaking. Got up about 5 am, and stood by the fireplace. Heavy shaking stopped by 7am. I continued with lighter shivers through the morning. Temperature taken at noon showed low grade fever of 99.4 .. Took Tylenol and felt better. Not much of an appetite had toast and chicken noodle soup to eat, lots of water. Following day I felt back to normal.
67 2021-03-27 sleep disorder 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 2021-03-28 disturbance in attention LPN called AID - Guest reported itchiness in her throat, and was losing her Train of Thought in and ... Read more
LPN called AID - Guest reported itchiness in her throat, and was losing her Train of Thought in and out. Offered some water and she was checked out by the attending Medics. Patient felt fine and Left facility. She declined increased observation.
67 2021-03-29 sleep disorder, excessive sleepiness 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 2021-03-31 amnesia 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 sleep disorder, loss of personal independence in daily activities On Tuesday, immediately after injection, I experienced numbness in my left hand, which has continued... Read more
On Tuesday, immediately after injection, I experienced numbness in my left hand, which has continued off an on. I attributed this to ongoing neck issues, so didn't think much of it, because I have it off and on. Numbness in right hand started about four hours after injection. This caught my attention. Extreme pain and redness in left arm started about three hours after injection. I could not use my left arm or lift it up. I applied ice for 10 minutes on and off every 15 minutes for a little over an hour before going to bed. It grew worse throughout the night. Fever started about six hours after injection and climbed to 101.1 before bedtime. Fever vacillated between 99.9 and 101 for about 16 hours on Wednesday. My neck hurt and I felt as if I had the full blown flu, but I couldn't sleep. No appetite. Wednesday afternoon, I developed pain in the right wrist and weakness in wrist and hand. It is painful to perform simple operations; for example, it is impossible for me to open a pop top can of soup. Left hand weakness and pain developed today, Thursday morning; pain in right hand, but especially the wrist, has worsened.
67 2021-04-02 confusional state Dizziness, muscle weakness, extreme fatigue, confusion
67 2021-04-02 fear Fever (100.8), chills, headache, nausea, sore arm at injection site,
67 2021-04-03 feeling abnormal 8 days after dose 1 of Moderna COVID-19 vaccine developed vertigo with distinct sense of motion even... Read more
8 days after dose 1 of Moderna COVID-19 vaccine developed vertigo with distinct sense of motion even when laying still; accompanied by headache, fatigue, tinnitus, nausea; all symptoms resolved over 5 days EXCEPT tinnitus which has gradually become louder and constant and more annoying. 3 months later tinnitus loud enough to need TV volume louder
67 2021-04-03 loss of personal independence in daily activities Moderna COVID-19 Vaccine EUA 7PM 3/11/2021 hands and body were very cold 2:30AM 3/12/2021 rose to us... Read more
Moderna COVID-19 Vaccine EUA 7PM 3/11/2021 hands and body were very cold 2:30AM 3/12/2021 rose to use the bathroom. Felt dizzy and weak. Could not make it back to the bed. Felt like I was going to faint, so just laid down on the floor for 5 minutes. Got really hot and sweaty. 3/13/2021 extremely tired (30% capacity) and back ached 3/14/2021 felt fine Since I've had fainting issues in the past, I realized I had to get to the floor, but if I hadn't been aware of that, I would have fainted. I have to be careful with the Lisinopril because I get dizzy when I get up too quickly. I did not get up too quickly that evening, though. I rested on the bed before I tried to walk. I had hydrated a LOT that day as the nurse advised me to do. Because I get dizzy with viruses, I it didn't seem unusual for my body to respond this way, but I thought I should report this.
67 2021-04-03 sleep disorder Systems started at Midnight and continued through early morning, 8:00 pm. I finally got to sleep. ... Read more
Systems started at Midnight and continued through early morning, 8:00 pm. I finally got to sleep. When I woke up, i just had mild systems-muscle ache and slight headache. Pain at the injection site Headache Chills Low grade fever (100.2) Muscle pain (all over my body-from head to toe) Skin hurt at touch Skin felt like a rash, but no redness Could not sleep, because I was so uncomfortable
67 2021-04-04 feeling abnormal By 7:00 AM the day after my second vaccine (Tues, Feb 23), I was sick as a dog- headache, muscle ac... Read more
By 7:00 AM the day after my second vaccine (Tues, Feb 23), I was sick as a dog- headache, muscle ache, nausea, and sore arm, with a temp of 100.3. At that time, I took 1 Advil. At 1:45 the same day (Tues), my temp was 101.4, and I felt absolutely awful. I considered going to a hospital. I took 2 Advil. I could barely walk from the couch to the bathroom. At 9:45 PM the same day (Tues), my temp was 101. On Wed, Feb 24, at 6:30 AM, I started to feel better, with improvement in my headache, body aches, and nausea. I was extremely fatigued. At 2:30 PM on Wed, my temp was 100.5, and I took 1 Advil. On Thurs, Feb 25 at 10:00 AM, my temp was 98.8, and I was able to function, albeit at a compromised level.
67 2021-04-04 insomnia Pain in arm injected severe, pain in all joints severe, intense headache, fatigue, all persisting fo... Read more
Pain in arm injected severe, pain in all joints severe, intense headache, fatigue, all persisting for a day and a half. First night was unable to sleep except for very short intervals. Was told by nurse giving shot not to take medication. Did say I could call doctor if needed, told her I'd probably just tough it out. Was told that was best. And that's what I did. It was awful.
67 2021-04-06 panic attack, nervousness, crying Patient received Moderna vaccine. She told pharmacist in IMZ room that she was very nervous about ge... Read more
Patient received Moderna vaccine. She told pharmacist in IMZ room that she was very nervous about getting the shot and felt nauseous. When patient went and sat down we noticed that it looked like she was crying. I went out to check on her and patient stated that she felt very nauseous and like she could not take a deep breath. I gave patient water and benadryl (10 ml of 12.5 mg/5 ml solution) and told her to take deep breaths in through the nose and out through the mouth. Within 30 seconds to 1 minute of taking the benadryl patient was feeling fine and able to breath normally again. It does seem that this may have been more of a panic attack or hyperventilation rather than a true allergic reaction due to the quick resolution of symptoms. Had patient stay an extra 15 mins in addition to traditional 15 mins for monitoring. called patient at 8 pm to check on her and she said she was still feeling ok as far as her breathing but had a slight fever and sore arm.
67 2021-04-07 feeling abnormal 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 2021-04-07 insomnia, anxiety, feeling abnormal 3/18/21 1:30 pm left arm pain, wrist joint pain. 8:00pm chills, warm, muscle and joint pain to both ... Read more
3/18/21 1:30 pm left arm pain, wrist joint pain. 8:00pm chills, warm, muscle and joint pain to both arms. Woke up 3 times during night to urinate, stomach ache. 5:00am 3/19/21moderate severe eye/face headache, had to take tylenol. woke up weak and diaphoretic. tired during morning , had to nap from 1-3pm. joint pain/headache returned at 8 pm requiring tylenol. 3/20/21 work up fine, no symptoms. then at 3 pm shakiness but only lasted few minutes. 3/21/21 work up 2am very anxious, read for an hour. work up at 630 feeling weird, very imbalance, had to hold onto furniture, increased with head movement, no pain. lasted about 2 hours. Insomnia has been continous since vaccine, 6-7 hours with interruptions. 4/5/21 bitter taste, foods taste different. eye pain intermittent since vaccine. finger joint pain (present prior to vaccine) seems to be worsening.
67 2021-04-07 sensation of foreign body, anxiety 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 2021-04-08 feeling abnormal March 24 3:15am chills ,fever 4pm vomiting, diarrhea, body aches, headache fatigued March 25 Tired, ... Read more
March 24 3:15am chills ,fever 4pm vomiting, diarrhea, body aches, headache fatigued March 25 Tired, headache March 26 Tired Headache, dry cough called doctor told if no better call Monday March 27 cough worse March 28 called doctor and was told to get a Covid test. Got covid test at 11;50am a March 29 cough, stuffy head feeling March 30 Covid Test Negative March 31 video call with doctor same conditions April 1 went for lung xray, doc called negative for pneumonia, started antibiotic Doxycyline 100mg 2x April 2 still sick April 3 still coughing mucous feeling in back of throat April 4 Fatigued, coughing April 5 still not feeling good April 6 seen physician assistant got bloodwork done April 7 Bloodwork results, WBC 11.2 Neutrophils, Absolute 6.9 both flagged H April 8 still tired April 9 return call to doctor spoke to nurse about bloodwork told drink plenty of fluids rest
67 2021-04-08 excessive sleepiness 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 sensation of foreign body March 24 3:15am chills ,fever 4pm vomiting, diarrhea, body aches, headache fatigued March 25 Tired, ... Read more
March 24 3:15am chills ,fever 4pm vomiting, diarrhea, body aches, headache fatigued March 25 Tired, headache March 26 Tired Headache, dry cough called doctor told if no better call Monday March 27 cough worse March 28 called doctor and was told to get a Covid test. Got covid test at 11;50am. March 29 cough, stuffy head feeling March 30 Covid Test Negative March 31 video call with doctor same conditions April 1 went for lung xray, doc called negative for pneumonia, started antibiotic Doxycyline 100mg 2x April 2 still sick April 3 still coughing mucous feeling in back of throat April 4 Fatigued, coughing April 5 still not feeling good
67 2021-04-08 sleep disorder itching started after vaccine at night both arms- keep awake but used eczema cream and help- goes af... Read more
itching started after vaccine at night both arms- keep awake but used eczema cream and help- goes after by morning- continuing every night x for 4-5 hours but goes away in the morning
67 2021-04-10 feeling abnormal Second day bedridden with extreme fatigue, sore arm, nausea, vomiting, fever up to 103° Fever began... Read more
Second day bedridden with extreme fatigue, sore arm, nausea, vomiting, fever up to 103° Fever began to go down and stomach began to be relieved by third day Fatigue remained until 4th day Sore arm remained until 5th day Still experiencing foggy brain
67 2021-04-10 insomnia Started with extreme pain in right shoulder injection site. Urinated about every hour, fever of 99.8... Read more
Started with extreme pain in right shoulder injection site. Urinated about every hour, fever of 99.8, extremely nauseous, excruciating headache, rigors throughout my body, teeth chattering, dizziness, weak, muscle aches. Could not get any relief from Tylenol or aspercreme. I did not sleep all night on 4/08/2021 until 7am 4/09/2021. The extreme shoulder pain lasted for 3 days. For 2 days I felt very weak and dizzy with a slight fever of 98. Since my symptoms went away after 3 days I did not contact a Dr. My son stayed with me in case of an emergency.
67 2021-04-11 thinking abnormal Crippling body aches, fever of 100.2, severe headache, chills, chest congestion, impaired cognition ... Read more
Crippling body aches, fever of 100.2, severe headache, chills, chest congestion, impaired cognition - lasted for 36 hours after injection
67 2021-04-12 euphoric mood 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 fear PATIENT WENT TO THE HOSPITAL AFRAID THAT SHE HAS A BLOOD CLOT.
67 2021-04-12 feeling abnormal, disturbance in attention, sleep disorder Felt fine on the day of vaccine (March 8) but during the following night flu-like aches, pains, shiv... Read more
Felt fine on the day of vaccine (March 8) but during the following night flu-like aches, pains, shivering and lethargy set in. Woke up at 2.30am feeling like I'd been knocked down by a bus and shivering uncontrollably. Really rather like a HUGE flareup of my Fibromyalgia. Tylenol didn't really help. Tossed and turned until 6am at which point I decided a cup of tea would be nice, especially as I couldn't stop shivering. Plus some stronger pain meds (Tylenol #3, which I usually take at bedtime to help get full and restful sleep). Put day clothes on for warmth and returned to bed. Finally able to get back to sleep around 9am. Day 2: spent most of the day in bed trying to get/keep warm in order to overcome the extreme whole-body pain. Only got up to get hot drinks and to eat something. Brain fog meant I couldn't concentrate on doing anything. Slept a lot. Day 3: Feeling MUCH better. My arm was a bit swollen and painful at the site of the shot. The body still felt like it had been in a boxing match and I was a tad sluggish, but the aches and pains were nowhere near as bad as the day before. Day 4: Most of the strong adverse symptoms were gone, except for milder pain and brain fog. Day 5: Now almost back to what constitutes 'normal' for me. Back to regular life but with plenty of rest as I find myself getting tired after moderate exertion.
67 2021-04-12 feeling abnormal Fatigue, headache, fever, chills, brain fog, loss of appetite, nausea, altered taste of certain food... Read more
Fatigue, headache, fever, chills, brain fog, loss of appetite, nausea, altered taste of certain foods . Duration as of April 13, 2021 is 17 days. Prednisone prescribed April 8, for 15 days 20 mg daily.
67 2021-04-12 sleep disorder Frozen shoulder pain improved significantly. Less pain, more range of motion, better sleep because l... Read more
Frozen shoulder pain improved significantly. Less pain, more range of motion, better sleep because less nighttime pain.
67 2021-04-13 excessive sleepiness Fatigue, aching joints, headache, slight fever, sensitive skin. Slept most of 36 hours, then was f... Read more
Fatigue, aching joints, headache, slight fever, sensitive skin. Slept most of 36 hours, then was fine.
67 2021-04-14 confusional state PER FAMILY CARE GIVER PT WAS GIVEN VACCINE AT 1PM, SHORTLY AFTER ARRIVING HOME CARE NOTED PT SEEMED ... Read more
PER FAMILY CARE GIVER PT WAS GIVEN VACCINE AT 1PM, SHORTLY AFTER ARRIVING HOME CARE NOTED PT SEEMED CONFUSED AND LETHARGIC, UPON ARRIVAL TO ER PT WAS UNRESPONSIVE AND INTUBATED
67 2021-04-14 feeling abnormal, sleep disorder Got the vaccine, the arm in which she received the vaccine became very swollen, and hard, and very d... Read more
Got the vaccine, the arm in which she received the vaccine became very swollen, and hard, and very deep red in color from the injection site all the way down to about 3" above the elbow. It's very hot to touch. She has been keeping ice on it and taking Tylenol for the pain. She is not getting any sleep due to the arm pain all night, and it's not just the tenderness but has burning shooting/sharp pain and an ache for a very short amount of time that feels like it's coming from the inside. It aches and comes and aches for a few seconds, and then goes away. The reaction to the arm that does not go away is that it feels like she has burned it. She did not call her doctor but did talk to her pharmacist who told her to call and report the reaction. She also has run a low grade fever and not feeling very good.
67 2021-04-14 loss of personal independence in daily activities Nearly 25 days after receiving my 1st Moderna vaccine I woke up on Easter morning with a very stiff ... Read more
Nearly 25 days after receiving my 1st Moderna vaccine I woke up on Easter morning with a very stiff Right wrist. By 1pm that day I was experiencing a lot of swelling and found it difficult to prepare food for a picnic we were going to. By 4pm that day I had to wrap my hand in ice, thinking it would provide some relief and took 2 Tylenol. By about 6:30 my husband and son were taking me to ER and on the way my Left hand began to swell and experience similar pain. By the time we arrived at the ER I was in excruciating pain in my entire hand up to my elbow and it felt like fire was burning through a vein up my arm. I had no use of my fingers which had stiffened and appeared maimed. After blood work, assessment, pain medication and steroid injection I was released with no real answers. other than to see my physician for follow-up. I was given a 12 RX for steroids which helped after the 4th day. I saw Dr. today, as she had been on vacation all last week. We discussed the possibility of an adverse reaction to the Moderna vaccine, and she recommended that I submit my information to you. 4/15/2021
67 2021-04-14 sleep disorder Severe left arm pain beginning and increasing in intensity; onset 3/19/21. Used ice packs, moist he... Read more
Severe left arm pain beginning and increasing in intensity; onset 3/19/21. Used ice packs, moist heat, acetaminophen, SalonPas pain patches w/lidocaine and rest constantly. Weakness and pain when using arm for any activity. Pain level consistently level 5 with intensity to 10 occasionally, 24/7. Pain radiates from elbow to below left ear and across left back muscle. Wakes me up consistently at night 4-5 times. First Dr visit was 4/1/21 via Zoom and was prescribed: Cephalexin 750 mg & Celecoxib 200 mg. 4/5/21 Dr visit (in person) prescribed Methcarbamol 750 mg. No relief was achieved with any of these meds. In person Dr visit 4/12/21 because I was so uncomfortable: prescribed Prednisone 20 mg & Hydrocodone/Acetaminophen 10-325. Pain med is helping me tolerate the pain so that I can function through the day somewhat. Still supplement with ice and heat. I do not feel that the meds have started working yet but have been taking them since 4/12/21 in the evening.
67 2021-04-15 hallucination Violent hallucination; Diarrhea; Rash; vomiting; This spontaneous case was reported by a consumer (s... Read more
Violent hallucination; Diarrhea; Rash; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HALLUCINATION (Violent hallucination) 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. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ALPHA-1-ANTITRYPSIN (ZEMAIRA) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravascular) 1 dosage form. On 23-Mar-2021, the patient experienced HALLUCINATION (Violent hallucination) (seriousness criterion medically significant). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), RASH (Rash) and VOMITING (vomiting). On 28-Mar-2021, HALLUCINATION (Violent hallucination) had resolved. At the time of the report, DIARRHOEA (Diarrhea), RASH (Rash) and VOMITING (vomiting) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravascular) was unknown. Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. Rash and vomiting are consistent with the product known safety profile.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. Rash and vomiting are consistent with the product known safety profile.
67 2021-04-16 anxiety, nervousness ANXIETY, NERVOUSNESS, FEELING FAINT.
67 2021-04-18 anxiety 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 feeling abnormal 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 2021-04-20 nightmare Day 1: Was awakened by a nightmare. Then, Throbbing intense headache, severe pain in entire left ar... Read more
Day 1: Was awakened by a nightmare. Then, Throbbing intense headache, severe pain in entire left arm which spread to shoulder, scapula and back ribs. Fever (no thermometer). Intense fatigue. Could not get out of bed for first 6 hours because of weakness. Loss of appetite for first 12 hours. Ate white rice and ginger ale only. Day 2: Fatigue continued, but to a lesser degree. Ate items from the BRAT diet. only Day 3: Continued to improve, but still had fatigue. Day 4: Felt like myself again.
67 2021-04-21 sleep disorder My left calf became red swollen & tender to touch. It hurt when I walked & couldn't sleep on my lef... Read more
My left calf became red swollen & tender to touch. It hurt when I walked & couldn't sleep on my left side to painfull. I had the shot on 3/27/21 & went to dr. on Mon 3/29/21, He put me on blood thinners Xarelto 4- 10mg & scheduled me for ultrasound next day. i have to be on blood thinners for 45 days & go back to dr on 5/10/21.
67 2021-04-22 sleep disorder Tinnitus. It lasted 3 days, only at night. Woke me up it was so loud, but I was able to go back to s... Read more
Tinnitus. It lasted 3 days, only at night. Woke me up it was so loud, but I was able to go back to sleep.
67 2021-04-24 mental status changes 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 2021-04-26 incoherent Became severely delusional, psychotic, incoherent, and combative for approximately 36 hours and went... Read more
Became severely delusional, psychotic, incoherent, and combative for approximately 36 hours and went to Hospital and received sedatives, blood tests, CT scan, EEG, MRI, chest x-ray and numerous other tests.
67 2021-04-26 loss of personal independence in daily activities Tongue swelled. Rash and Abcesses on all sides of tongue. Hurt. Sore to eat and talk. Went to my ... Read more
Tongue swelled. Rash and Abcesses on all sides of tongue. Hurt. Sore to eat and talk. Went to my Primary Dr. Used Kanka sore gel. Oral gel. Rinsed with hot salt water. Rinsed with BC powder. Took 2 Advil. Symptoms lasted about one week.
67 2021-04-27 feeling abnormal Client had first dose of Moderna at 3:16pm. At 3:20pm client alerted observation area nurse that ... Read more
Client had first dose of Moderna at 3:16pm. At 3:20pm client alerted observation area nurse that she felt a strange feeling on her lips PHN was alerted and at 3:21pm client reports mouth and tongue "feel weird" and that she has a history of high blood pressure and COPD and takes Lisinopril and spirivia and albuterol. Client reports feeling tongue swelling up. Take vitals blood pressure: 200/102, pulse: 94 and oxygen: 98%. PHN called 911 at 3:23pm. Vitals taken again at 3:29pm blood pressure: 185/90, pulse:97 and oxygen:97%. Fire arrived at 3:31pm to assume care. At 3:40pm client left facility on a gurney.
67 2021-04-27 sleep disorder 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 2021-04-29 sleep disorder, insomnia I woke up at 3:00 am out of a sound sleep on 3/19/21 with a very, unusual headache, whereby I could ... Read more
I woke up at 3:00 am out of a sound sleep on 3/19/21 with a very, unusual headache, whereby I could hardly keep my eyes open. I also had a stuffy nose, and felt slightly nauseous. I was exhausted and had difficulty going back to sleep. Around 10:00 pm on 3/20/21, I noticed a rash on my upper chest and my midriff was bright red. On 3/21/21 most of my front and back torso began to itch. On 3/22/21 the itching stopped.
67 2021-04-30 feeling abnormal Had an emergency surgery at the hospital due to a necrotizing fasciitis; Boiling not on the injectio... Read more
Had an emergency surgery at the hospital due to a necrotizing fasciitis; Boiling not on the injection site; Fever; Been fuzzy; Started to feel nauseated for a few days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECROTISING FASCIITIS (Had an emergency surgery at the hospital due to a necrotizing fasciitis), FURUNCLE (Boiling not on the injection site), PYREXIA (Fever), NAUSEA (Started to feel nauseated for a few days) and FEELING ABNORMAL (Been fuzzy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and GLIPIZIDE for Diabetes, ESCITALOPRAM OXALATE (LEXAPRO) and ATORVASTATIN 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 09-Apr-2021, the patient experienced NAUSEA (Started to feel nauseated for a few days). On 15-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NECROTISING FASCIITIS (Had an emergency surgery at the hospital due to a necrotizing fasciitis) (seriousness criteria hospitalization, medically significant and intervention required). On an unknown date, the patient experienced FURUNCLE (Boiling not on the injection site), PYREXIA (Fever) and FEELING ABNORMAL (Been fuzzy). The patient was hospitalized on 15-Apr-2021 due to NECROTISING FASCIITIS. The patient was treated with Surgery for Necrotising fasciitis. At the time of the report, NECROTISING FASCIITIS (Had an emergency surgery at the hospital due to a necrotizing fasciitis) and FEELING ABNORMAL (Been fuzzy) had not resolved, FURUNCLE (Boiling not on the injection site) and PYREXIA (Fever) outcome was unknown and NAUSEA (Started to feel nauseated for a few days) had resolved. Concomitant products also included allergy medicines. 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. On 08 Mar 2021, patient received first dose of Moderna COVID-19 Vaccine. On 05 Apr 2021, patient received second dose of Moderna COVID-19 Vaccine on either right or both arms as she couldn't remember. Patient reported that four days after receiving the second dose of vaccine, she felt nauseated for a few days and then started with a fever and a boiling, not on the injection site. On 15 Apr 2021, the patient had an emergency surgery at the hospital due to a necrotizing fasciitis. The patient said they needed to cut it out immediately because it was a flesh eating bacteria in the groin area. The patient mentioned that has been fuzzy and couldn't remember its friend's name when asked for a possible AE it mentioned. The patient had diabetes but that was doing well and was completely healthy. Treatment information included doxycycline (doxi something), multiple kind of antibiotics and fentomicine. The patient mentioned it (the wound) has to heal from inside out.; 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 medical history of diabetes mellitus could be a contributory risk factor for the necrotizing fasciitis
67 2021-05-03 feeling abnormal On Friday April 30 I developed a herpes rash on the right side of my face following my trigeminal ne... Read more
On Friday April 30 I developed a herpes rash on the right side of my face following my trigeminal nerve which was much larger and more intense than I have ever had in the past. This progressed until Monday, May 4 into a large scab. I had the typical symptoms of a Herpes outbreak: feeling out of sorts, fatigue, pain at the rash site
67 2021-05-04 sleep disorder After 12 hrs severe chills teeth chattering could not get warm aches burning in leg arms head hot ar... Read more
After 12 hrs severe chills teeth chattering could not get warm aches burning in leg arms head hot arm severe pain 2 days felt like I had surgery on arm severe back neck pain, breathing had to use inhalers 5 times in the night I could not move or walk could not sleep all night migrain head ache same on both shots thought I was not going to make it this time, kept praying all night had severe sweats when 104 fever broke that lasted 8 hours
67 2021-05-06 disturbance in attention, irritability, feeling abnormal, insomnia Beginning 03/28/21, experienced severe body aches and pains, nausea, extreme fatigue, loss of appeti... Read more
Beginning 03/28/21, experienced severe body aches and pains, nausea, extreme fatigue, loss of appetite, bad headache/migraine and irritability. These symptoms lasted for about five days. From the sixth day to present (05/07/21), I have had brain fog, extreme fatigue, compromised ability to concentrate, uncharacteristic irritability, mood swings, some loss of appetite, malaise, headache (not migraine) and inability to sleep well.
67 2021-05-06 insomnia After first dose arm pain two days late stomach ache severe nausea pains in joints stiff neck fever ... Read more
After first dose arm pain two days late stomach ache severe nausea pains in joints stiff neck fever 100.6 teeth chattering chills and the worst headache of my life thought my head would explode Dr told me to take tylenol went to bed under covers the next day fatigue which has lingered throughout and frequent stomach and abdominal pains. reluctant to take second dose but drs convinced me since i care for the elderly after another negative covid test i went for second dose arm pain severe fatigue still experiencing stomach issues on May 1,2021 severe stomach issues slight headache extreme fatigue the next night i had trouble walking and couldn't bend my knee no sleep excrutiating pain in joints right hand swollen and lacking in movement severe abdominal issues went to hospital emergency room RA crisis bones bad
67 2021-05-08 delirium, mental status changes, confusional state 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 2021-05-12 depressed mood, confusional state, anxiety, mental impairment 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 feeling abnormal First shot next day had headache, some aches and pains and very tired. Second shot about 3 hours af... Read more
First shot next day had headache, some aches and pains and very tired. Second shot about 3 hours after shot my head felt strange got and instant severe headache then my vision went blurry for about half hour then the blurry went away but still had a headache and tightness or pressure of my head, later during the night woke up with my body hurting aching and very tired, still had headache took tylonal, this continued on through most of the next day but subsided. The third day still had headache but mild and aches went away, and a bit tired. I am still having head aches and it has been 18 days. Have sent a message with the same information for my records.
67 2021-05-13 sleep disorder After first injection, I received daily and weekly surveys. This time I didn't, this is the reason ... Read more
After first injection, I received daily and weekly surveys. This time I didn't, this is the reason I'm filling out this form. This time, about 3 hours after the Moderna injection #2, I started having body aches and general malaise. The first night I ached so badly, it woke me up. My fingers and even my butt cheeks were aching.
67 2021-05-16 nervousness, feeling abnormal Tired, queasy, slightly dizzy, low energy, thirsty, slight vision reduction, brain fog, washed out, ... Read more
Tired, queasy, slightly dizzy, low energy, thirsty, slight vision reduction, brain fog, washed out, shaky
67 2021-05-18 emotional distress, nervousness, feeling abnormal 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 2021-05-19 impaired work ability, depressed mood, feeling abnormal, sleep disorder Eleven days after second Moderna vaccine, I started getting lightheaded. It has continued to grow w... Read more
Eleven days after second Moderna vaccine, I started getting lightheaded. It has continued to grow worse during the past four weeks. My tinnitus is now significantly worse (constant loud ringing), and I become fatigued easily. Sometimes I sleep a lot, other times I cannot sleep. I have dizziness and lighteadedness constantly. I recently started getting tingling in my arms and numb hands. Had a bout of tingling in my legs like restless leg syndrome. Feel tingling in my nasal area. I have brain fog and have a hard time working. I am extremely weak. Went to three doctors (2 urgent care and my primary care doctor) and my chiropractor is working with me to lessen affects. I can only equate it to the vaccine since I have no other apparent issues they can find. I am getting quite depressed about my overall health and well being.
67 2021-05-20 sleep disorder, impaired work ability 3/9/21 Received vaccine around 3:53 pm. 3/10/21 12:30 am - awoke feeling hot and sweaty and having... Read more
3/9/21 Received vaccine around 3:53 pm. 3/10/21 12:30 am - awoke feeling hot and sweaty and having a slight headache and muscle aches. Went back to sleep but awoke two or three more times throughout the night, each time feeling a little worse. 3/10/21 5:30 am - Got up to try to go to work: Had significant vertigo, headache was now much worse (felt like a migraine), nausea and severe body aches. Still felt very hot. 3/10/21 8:00 am - Went to work. Temperature was 100.7. Went directly home. 3/10/21 8:15 am - Back at home. 3/10/21 8:15 am - 3/11/21 6:00 am - Headache was very severe. Vomited. Went to bed to try to sleep. Headache and nausea kept waking me up. I didn't have a thermometer at home but I continued to feel extremely hot and sweaty. I'm usually very cold. Could not even sip liquids or it caused vomiting. 3/11/21 6:00 am - 6 pm - vision was impaired. It looked like my room was filled with smoke. Nausea continued. Slept most of this time 3/11/21 6:30 pm - Woke up. Nausea was much less. I was able sip liquids. Headache was less. 3/12/21 6:30 am - Woke up. Nausea only slight. Headache only slight 3/13/21 6:30 am - Much better
67 2021-06-01 feeling abnormal 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 2021-06-13 impaired work ability, sleep disorder 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 2021-06-14 feeling abnormal Feel sick; Felt really bad; Neck Pain; Nausea; This spontaneous case was reported by a consumer (sub... Read more
Feel sick; Felt really bad; Neck Pain; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Feel sick) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MALAISE (Feel sick) (seriousness criterion hospitalization), FEELING ABNORMAL (Felt really bad), NECK PAIN (Neck Pain) and NAUSEA (Nausea). At the time of the report, MALAISE (Feel sick), FEELING ABNORMAL (Felt really bad), NECK PAIN (Neck Pain) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Laboratory test: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 13-Mar-2021, the patient felt very sick that she ended up going to Emergency. The patient stated that she stayed in hospital for a whole da. 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.
67 2021-06-15 depression, irritability, feeling abnormal The next morning - I had a fever, body aches, flu-like, headache - 09:00 am - 07:00 or 8 at night. W... Read more
The next morning - I had a fever, body aches, flu-like, headache - 09:00 am - 07:00 or 8 at night. Within a couple of days, (COVID gave me a horrible cough which I'm still not over) my cough came back with a vengeance. I couldn't stop coughing. I had more body aches and felt like I couldn't recover if I tried to do a little workout - it would stay sore. I continued to have muscle soreness, aches and pains and also I brain fog. (I had COVID symptoms prior to the vaccines with COVID stuff.) It seemed like it brought all the COVID inflammation back. Brain fog is now 90% gone but I do still hit a wall every day at about 05:00 pm or so in the evening; when it was at it's worse, I couldn't think in a straight line. Decisions were really hard and I ended up being depression from that - felt alone, tired and whiny. I asked for help from a bunch of people including a naturopath - gave me adrenal support and mitochondrial support and so my symptoms are improving. I still have coughing but I'm slowly getting better. I still get tired and brain fog is better but it's not gone yet.
67 2021-06-16 depression Benadryl depression
67 2021-06-16 feeling abnormal I had a high fever, chills, muscle aches, lack of appetite, headache, and feeling horribly. I also, ... Read more
I had a high fever, chills, muscle aches, lack of appetite, headache, and feeling horribly. I also, had a chronic cough after the vaccine.
67 2021-06-17 thinking abnormal huge big welts on frontside and on back and one on the middle of spine and on lower spine and one on... Read more
huge big welts on frontside and on back and one on the middle of spine and on lower spine and one on right breast; really uncomfortable; rash was on sholders and back /got itchy spots of clumps on each side of the back of neck which went up into hairline /had the spots on shoulders, and each rash looked different than the other/horrible itching and these rashes; having a reaction to the shot/described as that body is in a hyper state of immune response/like body is fighting an immune response to something; MAC lung disease progression; shaking; feeling strange and was feeling like \was fighting to stay conscious and shivering /dizzy but felt like was going to pass out; thinking would throw up; "thinking she would throw up; MAC lung disease progressing; felt ice cold / being cold; rash on shoulder and back/rash on shoulders looked different from the rash on back/; rash was red; that was red; swollen arm; Hot swollen arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISEASE PROGRESSION (MAC lung disease progressing), ALLERGY TO VACCINE (having a reaction to the shot/described as that body is in a hyper state of immune response/like body is fighting an immune response to something) and MYCOBACTERIUM AVIUM COMPLEX INFECTION (MAC lung disease progression) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Shingles in 2001, Chickenpox in 2001, Mycobacterium avium complex infection since an unknown date and Hives. Concurrent medical conditions included Hyperlipaemia, Sleep disorder and Contrast media allergy. Concomitant products included ROSUVASTATIN for Hyperlipidemia, ESZOPICLONE (LUNESTA) for Sleep disorder NOS. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot swollen arm), VACCINATION SITE ERYTHEMA (that was red) and VACCINATION SITE SWELLING (swollen arm). In March 2021, the patient experienced ERYTHEMA (rash was red) and RASH PAPULAR (rash on shoulder and back/rash on shoulders looked different from the rash on back/). On 27-Apr-2021, the patient experienced FEELING COLD (felt ice cold / being cold). On 28-Apr-2021, the patient experienced DISEASE PROGRESSION (MAC lung disease progressing) (seriousness criterion medically significant), MYCOBACTERIUM AVIUM COMPLEX INFECTION (MAC lung disease progression) (seriousness criterion medically significant), TREMOR (shaking), VACCINATION COMPLICATION (feeling strange and was feeling like \was fighting to stay conscious and shivering /dizzy but felt like was going to pass out), THINKING ABNORMAL (thinking would throw up) and NAUSEA ("thinking she would throw up). On 08-May-2021, the patient experienced ALLERGY TO VACCINE (having a reaction to the shot/described as that body is in a hyper state of immune response/like body is fighting an immune response to something) (seriousness criterion medically significant). On an unknown date, the patient experienced URTICARIA (huge big welts on frontside and on back and one on the middle of spine and on lower spine and one on right breast), DISCOMFORT (really uncomfortable) and RASH PRURITIC (rash was on sholders and back /got itchy spots of clumps on each side of the back of neck which went up into hairline /had the spots on shoulders, and each rash looked different than the other/horrible itching and these rashes). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Rash, at a dose of 1 dosage form; CORTISONE at a dose of 1 dosage form; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form; AMOXICILLIN for Pneumonia, at a dose of UNK dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 11-May-2021 at a dose of 1 dosage form and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency. On 09-Feb-2021, VACCINATION SITE WARMTH (Hot swollen arm) had resolved. At the time of the report, DISEASE PROGRESSION (MAC lung disease progressing), ALLERGY TO VACCINE (having a reaction to the shot/described as that body is in a hyper state of immune response/like body is fighting an immune response to something), MYCOBACTERIUM AVIUM COMPLEX INFECTION (MAC lung disease progression), URTICARIA (huge big welts on frontside and on back and one on the middle of spine and on lower spine and one on right breast), TREMOR (shaking), FEELING COLD (felt ice cold / being cold), DISCOMFORT (really uncomfortable), ERYTHEMA (rash was red), VACCINATION COMPLICATION (feeling strange and was feeling like \was fighting to stay conscious and shivering /dizzy but felt like was going to pass out), THINKING ABNORMAL (thinking would throw up), NAUSEA ("thinking she would throw up) and VACCINATION SITE ERYTHEMA (that was red) outcome was unknown, RASH PAPULAR (rash on shoulder and back/rash on shoulders looked different from the rash on back/) and RASH PRURITIC (rash was on sholders and back /got itchy spots of clumps on each side of the back of neck which went up into hairline /had the spots on shoulders, and each rash looked different than the other/horrible itching and these rashes) had not resolved and VACCINATION SITE SWELLING (swollen arm) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Biopsy: not provided (Inconclusive) 2 biopsies done Results-not provided. On 28-Apr-2021, Body temperature: 91.1 (Inconclusive) 91.1 and 95.2 (Inconclusive) 95.2. On 28-Apr-2021, Chest X-ray: no results provided (Inconclusive) no results provided. On 28-Apr-2021, Computerised tomogram: mass in lung (Inconclusive) Mass in lung. On 28-Apr-2021, Electrocardiogram: normal (normal) normal. On 08-May-2021, Body temperature: 95.3 (Inconclusive) 95.3. On an unknown date, Biopsy: possible drug allergy (Inconclusive) Possible drug allergy. On an unknown date, Blood test: inconclusive (Inconclusive) Sepsis was ruled out. On an unknown date, Body temperature: 95.8 (Inconclusive) 95.8 and 95.5 (Inconclusive) 96.5. Treatment medication included Cortisone cream for itching, Allegra (took twice), Zyntec and Valtrex for symptoms, Amoxicillin for Pneumonia and Benadryl on 11May2021. Concomitant medications included Cholesterol and sleeping pills. 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 US-MODERNATX, INC.-MOD-2021-020008 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up added on 25-May-2021 included significant data: New events added. Treatment medications and conmeds added. Lab 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.
67 2021-06-19 confusional state, loss of personal independence in daily activities, impaired work ability, excessive sleepiness, feeling abnormal I got my second vaccine on 2-24. For 2 days after the vaccine, I experienced chills, a high fever (1... Read more
I got my second vaccine on 2-24. For 2 days after the vaccine, I experienced chills, a high fever (102), sweats, and overall body aches. By 2-28, I was feeling tired but no symptoms. By March 3, I started to experience severe exhaustion again, plus unusual brain fog, and paresthesia. I went to ER and was checked for stroke. Given MRI and blood tests. Some energy returned by 3-6. On 3-9, severe fatigue returned along with increased cognitive confusion. I was unable to function as I was sleeping up to 15 hours a day 3 or 4 x's a week. I had to stop working. I was referred to a rheumatologist in March and started getting blood tests. Blood tests show high titers of AMA, ANA,RNAl.Doc suspected AI disease and begin elimination testing. In May 2021, I had a liver fibroscan, ultra sound, and biopsy. Biopsy showed bile duct inflammation. In early June 2021, a gastroenterologist, gave Dx of Primary Biliary Cholangitis. Rx Eursodiol. (Rheumotologist had Rx Hydroxychlorquine before PCB Dx but I never started that.) I have been taking Ursodiol for 2 weeks. Still battling fatigue but it is lessening. I still get fatigued if I do simple adult activities like grocery shop, do light house cleaning, go out for simple dinner.
67 2021-06-23 confusional state Awoke very dizzy/confused. Could not walk in straight line. Veered left/ right. Easedxas day progres... Read more
Awoke very dizzy/confused. Could not walk in straight line. Veered left/ right. Easedxas day progressed. Called EMT to rule out CO2 or any gas/ environmental issues. Far less severe than sister who was hospitalized previous day.
67 2021-06-23 loss of personal independence in daily activities After 1st injection, left shoulder was tender and did not go away. Received 2nd injection in the sam... Read more
After 1st injection, left shoulder was tender and did not go away. Received 2nd injection in the same arm and tenderness increased. In April, started to have some decreased mobility in arm. The beginning of May pain increased and continued to increase over the month. Made appointment with Orthopedic Dr specializing in shoulders, but could not be seen until 6/23. Took over the counter analgesics to try to relieve pain. Unable to complete simple daily tasks without assistance. Very painful. Saw physician 6/23 and had x-rays. Diagnosed with Adhesive capsulitis (Frozen Shoulder) Physical Therapy prescribed for 6 weeks. Still in severe pain.
67 2021-06-27 feeling abnormal Completed consult regarding patient's hospitalization due to broken leg. Pt received 2nd Moderna COV... Read more
Completed consult regarding patient's hospitalization due to broken leg. Pt received 2nd Moderna COVID 19 vaccine on March 12th Lot#048A1A and felt different the next few days and wobbly/off balance which is not usual for her. She does walk with a walker but is normally well balanced. She fell March 14, 2021 and her left got caught under the sofa and she broke her leg. Pt wanted to make a report to CDC to let them know how she felt the day she broke her leg. She was hospitalized from 3/14/21 to 4/26/2021 which included her care in subacute care. Her 1st dose of Moderna was on Feb 12, 2021 Lot#011M20A. Reported to VAERS and patient is doing well and recovering.
67 2021-06-28 mental impairment 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 2021-06-30 sleep disorder On the day after my second vaccine on 1/28, I had muscle type throbbing in my right thigh. It stopp... Read more
On the day after my second vaccine on 1/28, I had muscle type throbbing in my right thigh. It stopped after 24 hours. Around 4/17 I had similar pain return but it was much more painful. The pain snd throbbing traveled from my upper thigh to my knee. It was mostly at night and I could not sleep at all.
67 2021-07-05 amnesia My wife became delusional for a short while, then lost her short term memory. She still does not hav... Read more
My wife became delusional for a short while, then lost her short term memory. She still does not have it back.
67 2021-07-08 feeling abnormal 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 insomnia Intense Nerve burning and full body pain; general muscle weakness, sleeplessness, digestive track sl... Read more
Intense Nerve burning and full body pain; general muscle weakness, sleeplessness, digestive track sluggishness and inflammation. Chronic ongoing nerve pain including neck, back, legs, arms. Treated with anti-inflammatory ibuprofen. Adverse effects have continued to this day. I?m concerned about permanent damage or continuing inflammation. (First vaccination produced 4 days of discomfort as well although different effects; malaise, general flu symptoms.
67 2021-07-10 feeling abnormal, loss of personal independence in daily activities Pre-pneumonia; Pains; Too much pain from her breast to her armpit; She started coughing; Feeling ve... Read more
Pre-pneumonia; Pains; Too much pain from her breast to her armpit; She started coughing; Feeling very bad right now; Now she cannot do anything; Too much pain from her breast to her armpit; She had high fever; This spontaneous case was reported by a consumer and describes the occurrence of ATYPICAL PNEUMONIA (Pre-pneumonia) 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. No Medical History information was reported. On 16-Jun-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 an unknown date, the patient experienced ATYPICAL PNEUMONIA (Pre-pneumonia) (seriousness criterion medically significant), PAIN (Pains), BREAST PAIN (Too much pain from her breast to her armpit), COUGH (She started coughing), FEELING ABNORMAL (Feeling very bad right now), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Now she cannot do anything), AXILLARY PAIN (Too much pain from her breast to her armpit) and PYREXIA (She had high fever). At the time of the report, ATYPICAL PNEUMONIA (Pre-pneumonia), BREAST PAIN (Too much pain from her breast to her armpit), FEELING ABNORMAL (Feeling very bad right now), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Now she cannot do anything), AXILLARY PAIN (Too much pain from her breast to her armpit) and PYREXIA (She had high fever) outcome was unknown and PAIN (Pains) and COUGH (She started coughing) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient got second dose of Moderna vaccine and went to emergency room and was diagnosed with pre-pneumonia, had high fever, pains, too much pain from breast to armpit. Patient was strong and had nothing before vaccine, now cannot do anything, started coughing (continues) and doctor prescribed some coughing medicine and still had pain. Concomitant medications were not reported. The action taken for m-RNA-1273 COVID-19 Moderna Vaccine was not applicable. Company Comment: This case concerns a 67-year-old female with a serious unexpected event of atypical pneumonia, and non-serious breast pain, feeling abnormal, loss of personal independence in daily activities, axillary pain and pyrexia. Event onset with unknown latency 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-2021-244483 (Patient Link).; Sender's Comments: This case concerns a 67-year-old female with a serious unexpected event of atypical pneumonia, and nonserious breast pain, feeling abnormal, loss of personal independence in daily activities, axillary pain and pyrexia. Event onset with unknown latency 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
67 2021-07-10 impaired work ability, delirium, memory impairment, loss of personal independence in daily activities, confusional state, feeling abnormal, sleep disorder, disturbance in attention 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 depressed mood New 5 and 7 mm ill-defined nodular densities are seen in the left upper\ increased calcification; Di... Read more
New 5 and 7 mm ill-defined nodular densities are seen in the left upper\ increased calcification; Difficulty breathing; Feeling hot; Increased thoracic kyphosis noted; Anterior spondylosis is seen in the upper lumbar; likely infectious or inflammatory in etiology; patient has increased mucus production; very dry cough with just little tiny specs of mucus; felt slightly crappy; Fever; back muscle spasms; little sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PNEUMONIA (likely infectious or inflammatory in etiology), PULMONARY CALCIFICATION (New 5 and 7 mm ill-defined nodular densities are seen in the left upper\ increased calcification), DYSPNOEA (Difficulty breathing) and COUGH (very dry cough with just little tiny specs of mucus) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chronic bronchitis (given gamma globulin shots, took up swimming and gradually the frequency for illness decreased (over a decade or so).), Pneumonia, Watering eyes, Runny nose and Hormone replacement therapy. Previously administered products included for an unreported indication: PNEUMOCOCCAL CONJUGATE VACCINE in October 2019. Concurrent medical conditions included Allergy to animal dander (Cat hair caused watery eyes, runny nose & stuffed head.) since 18-Dec-1972, Allergy to animal dander (dog hair caused watery eyes, runny nose & stuffed head.) since 18-Dec-1972, Allergy to animals (cattle caused watery eyes, runny nose & stuffed head.) since 18-Dec-1972 and Smoke inhalation (tobacco mix caused watery eyes, runny nose & stuffed head.) since 18-Dec-1972. Concomitant products included TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) from 05-Jan-2018 to an unknown date for Contact dermatitis, PREGNENOLONE from 09-Jan-2007 to an unknown date and PROGESTERONE from 09-Jan-2007 to an unknown date for HRT, KRILL OIL, UBIDECARENONE (COQ10 [UBIDECARENONE]) and CRANBERRY [VACCINIUM MACROCARPON] for Supplementation therapy, CYANOCOBALAMIN (VIT B12) and COLECALCIFEROL (VIT D3) for Vitamin supplementation. On 28-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MUSCLE SPASMS (back muscle spasms) and PAIN IN EXTREMITY (little sore arm). On 29-Jan-2021, the patient experienced PYREXIA (Fever). On 31-Jan-2021, the patient experienced DEPRESSED MOOD (felt slightly crappy). On 01-Feb-2021, the patient experienced PRODUCTIVE COUGH (patient has increased mucus production) and COUGH (very dry cough with just little tiny specs of mucus) (seriousness criterion medically significant). On an unknown date, the patient experienced PNEUMONIA (likely infectious or inflammatory in etiology) (seriousness criterion medically significant), PULMONARY CALCIFICATION (New 5 and 7 mm ill-defined nodular densities are seen in the left upper\ increased calcification) (seriousness criterion medically significant), DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), FEELING HOT (Feeling hot), KYPHOSIS (Increased thoracic kyphosis noted) and SPINAL OSTEOARTHRITIS (Anterior spondylosis is seen in the upper lumbar). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of UNK dosage form; BENZONATATE (oral) ongoing since an unknown date for Cough, at a dose of 200 mg; AZITHROMYCIN (oral) ongoing since an unknown date for Mucus discharge, at a dose of 250 mg and FLUTICASONE PROPIONATE (FLOVENT HFA) (oral) ongoing from 25-Feb-2021 for Adverse event, at a dose of 200mcg/act aer glax. On 29-Jan-2021, PAIN IN EXTREMITY (little sore arm) and PYREXIA (Fever) had resolved. On 30-Jan-2021, MUSCLE SPASMS (back muscle spasms) had resolved. On 31-Jan-2021, DEPRESSED MOOD (felt slightly crappy) had resolved. On 28-Apr-2021, PNEUMONIA (likely infectious or inflammatory in etiology), PRODUCTIVE COUGH (patient has increased mucus production), PULMONARY CALCIFICATION (New 5 and 7 mm ill-defined nodular densities are seen in the left upper\ increased calcification), DYSPNOEA (Difficulty breathing), COUGH (very dry cough with just little tiny specs of mucus), FEELING HOT (Feeling hot), KYPHOSIS (Increased thoracic kyphosis noted) and SPINAL OSTEOARTHRITIS (Anterior spondylosis is seen in the upper lumbar) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, COVID-19: negative (Negative) negative. On 11-Feb-2021, Chest X-ray: inconclusive (Inconclusive) New 5 and 7 mm ill-defined nodular densities are seen in the left upper lobe compared with 2007. On 15-Feb-2021, Computerised tomogram thorax: inconclusive (Inconclusive) Chest x-ray findings correspond with mild left upper lobe ground-glass opacities, likely infectious or inflammatory in etiology. Lungs, Pleura and Airways: Mild left upper lobe stellate peribronchovascular and subpleural ground-glass opacities. No airway narrowing or obstruction. No pleural effusion or pneumothorax.. 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 started taking flu shots in her 50s which did help. On Monday 08 Feb 2021, patient called her PCP, and had a zoom call. She prescribed a cough med and suggested I get a chest xray and Ct scan. The medication helped a bit with the cough (especially at night) but she still had mucus production. Patient had another call with PCP on 16Feb 2021, where she prescribed a five day course of antibiotic, but that didn't result in clearing up the mucus production either. Patient was but on an inhaler to help clear up the likely infection/mucus. Patient had little to no (new) symtoms as a result of the 2nd shot. Patient used the inhaler for about two months and gradually the mucus production and cough went away. Patient weaned myself off the inhaler over the course of the first 2-3 weeks in May and was perfectly fine until she went in to have the pneumonia vaccine (PPSV-23) on 13 Jun 2021. After the shot patient's mucus production started up again and patient started back on the inhaler but only once a day, which seems to keep my symptoms in check. Patient met PCP on 29 Feb 2021, to talk about this on-going lung issue. Patient was going to take a pulmonary Function Test some time this month (July). Based on the current 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-2021-246799 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No new information. On 05-Jul-2021: Follow-up case - Second dose, height, weight, ethnic group, race, previous allergies, concomitant medications, treatment medications, new labs added. Action taken event outcome and inarrative 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. Further information has been requested.
67 2021-07-13 feeling abnormal Shortly after receiving my second Moderna Vaccine, I started having leg cramps mostly during the nig... Read more
Shortly after receiving my second Moderna Vaccine, I started having leg cramps mostly during the night. They were not severe for the first few months. I would get out of bed and walk a bit then go back to sleep. In the June timeframe, my tendons began to retract more and more to the point that it became very painful to flatten my foot on the floor. That lasted for a month. Today, when I sleep, I feel what I would describe as a waving sensation through my calves and feet when I sleep. The cramping has lessened. I thought you would like me to report this. I can't possibly know if related to the vaccine, but have never had this issue in my past. I am in excellent health.
67 2021-07-17 sleep disorder Sore L arm and shoulder since first week of April- 2021. Difficulty raising my left arm, moving it, ... Read more
Sore L arm and shoulder since first week of April- 2021. Difficulty raising my left arm, moving it, and sleeping on my left side. Worsening since then.
67 2021-07-18 feeling abnormal 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 2021-07-21 anxiety, nervousness Pt. states after receiving the 2nd dose of Moderna 02/14/2021, started experiencing symptoms 02/22/2... Read more
Pt. states after receiving the 2nd dose of Moderna 02/14/2021, started experiencing symptoms 02/22/2021 of extreme nerve pain in the legs/hands/feet, fatigue, flu-like symptoms. Primary visit with X-ray (Sprain) 02/28/2021, both feet started experiencing neuropathy throughout the body. Nervousness and anxiety resulting in early retirement. Body aches and nerve pain still continuing. Neurologist seen Perennial+1 diagnosed. No other noted symptoms still continuing Primary visits.
67 2021-07-22 loss of personal independence in daily activities Flu-like symptoms: achy, headache, chills, difficulty getting out of bed.
67 2021-07-27 memory impairment, feeling abnormal, mental impairment, sleep disorder can't think straight; urine retention decreased to a fourth of its normal capacity; flu like symptom... Read more
can't think straight; urine retention decreased to a fourth of its normal capacity; flu like symptoms/She had a bad case of flu; hot flushes; stomach ache; diarrhea; extreme pain in her foot; extreme pain in her right side/pain in her crest and hips; extreme pain in her lower back; she had an infection somewhere; pain in the vaginal area like her vagina was partially swollen, it felt like she had had sex ut she hasn't had in 20 years; talking in her sleep; cane; She did not feel like herself at all; She woke up 3 times at nights; Elevated enzyems; swollen vagina; She forgot what she was doing, like putting ice cream in the fridge and forgetting about it; chills; muscle pain/muscle aches that traveled around her body; joint pain; tired all the time; nausea real bad; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (can't think straight) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Knee injury. Concurrent medical conditions included Cholesterol high. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced MENTAL IMPAIRMENT (can't think straight) (seriousness criterion medically significant), URINARY TRACT DISORDER (urine retention decreased to a fourth of its normal capacity), INFLUENZA LIKE ILLNESS (flu like symptoms/She had a bad case of flu), HOT FLUSH (hot flushes), ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (extreme pain in her foot), PAIN (extreme pain in her right side/pain in her crest and hips), BACK PAIN (extreme pain in her lower back), INFECTION (she had an infection somewhere), VULVOVAGINAL PAIN (pain in the vaginal area like her vagina was partially swollen, it felt like she had had sex ut she hasn't had in 20 years), SLEEP TALKING (talking in her sleep), WALKING AID USER (cane), FEELING ABNORMAL (She did not feel like herself at all), SLEEP DISORDER (She woke up 3 times at nights), ENZYME LEVEL INCREASED (Elevated enzyems), VULVOVAGINAL SWELLING (swollen vagina), MEMORY IMPAIRMENT (She forgot what she was doing, like putting ice cream in the fridge and forgetting about it), CHILLS (chills), MYALGIA (muscle pain/muscle aches that traveled around her body), ARTHRALGIA (joint pain), FATIGUE (tired all the time) and NAUSEA (nausea real bad). At the time of the report, MENTAL IMPAIRMENT (can't think straight), URINARY TRACT DISORDER (urine retention decreased to a fourth of its normal capacity), PAIN IN EXTREMITY (extreme pain in her foot), PAIN (extreme pain in her right side/pain in her crest and hips), BACK PAIN (extreme pain in her lower back), INFECTION (she had an infection somewhere), VULVOVAGINAL PAIN (pain in the vaginal area like her vagina was partially swollen, it felt like she had had sex ut she hasn't had in 20 years), SLEEP TALKING (talking in her sleep), WALKING AID USER (cane), FEELING ABNORMAL (She did not feel like herself at all), SLEEP DISORDER (She woke up 3 times at nights), ENZYME LEVEL INCREASED (Elevated enzyems), VULVOVAGINAL SWELLING (swollen vagina), MEMORY IMPAIRMENT (She forgot what she was doing, like putting ice cream in the fridge and forgetting about it), MYALGIA (muscle pain/muscle aches that traveled around her body), ARTHRALGIA (joint pain) and FATIGUE (tired all the time) outcome was unknown and INFLUENZA LIKE ILLNESS (flu like symptoms/She had a bad case of flu), HOT FLUSH (hot flushes), ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea), CHILLS (chills) and NAUSEA (nausea real bad) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Laboratory data included: On 01-JUL-2021, a blood test was done (patient had 4 in total). When the blood work came back, he said she had an infection somewhere and that her "CP" was up. No treatment information 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. Concomitant medical conditions could be potentially confounders for the 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. Concomitant medical conditions could be potentially confounders for the events.
67 2021-07-28 feeling abnormal, loss of personal independence in daily activities, impaired work ability After receiving the vaccine, that night, I didn't feel good at all. The next morning I had a fever o... Read more
After receiving the vaccine, that night, I didn't feel good at all. The next morning I had a fever of 104, body aches and severe chills. I also got a rash all over my body, from head to toe. I had them symptoms for at least four days and the rash for about eight days. I was dizzy and weak. I wasn't able to work for five days. It felt like I had the flu. I was really feeling bad. I couldn't do a thing. I was out of town and had to get my grandson to fly and come get me. I couldn't do a thing for myself.
67 2021-07-28 mental status changes, confusional state 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 sleep disorder Woke up during night after getting the vaccine with Chills, fever, achy- Took Tylenol about 6:30 am... Read more
Woke up during night after getting the vaccine with Chills, fever, achy- Took Tylenol about 6:30 am . Fever came down., but returned. 6 hrs later I took ibuprofen and within 2 hours I begin to feel better. By 7:30 PM on Jan 1st I felt normal.
68 2021-01-03 mental impairment 12/29 Injection site soreness 12/30 Fatigue, SOB, cough, muscle aches, mental slowness; increased se... Read more
12/29 Injection site soreness 12/30 Fatigue, SOB, cough, muscle aches, mental slowness; increased secretions with cough
68 2021-01-05 anxiety Received vaccine at 1545; c/o itching and rash at 1556 bp 186/82-78 anxious; 1559 Benadryl 50 mg p... Read more
Received vaccine at 1545; c/o itching and rash at 1556 bp 186/82-78 anxious; 1559 Benadryl 50 mg po given; rash red and raised scattered across hand and torso; 1606 146/74-68-20 rash is flat and better less itching; 1623 165/66- 84; 1630 pt itching on right upper extremity and whelps noted. Soumedrol 125 mg IV given; 1702 feels better and rash less red; 1711 resolved
68 2021-01-05 feeling abnormal Does not have the lot#. Redness, swelling, area is very warm. This started this morning. Feels ti... Read more
Does not have the lot#. Redness, swelling, area is very warm. This started this morning. Feels tired, under the weather. Little dizziness.
68 2021-01-05 nervousness 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 sensation of foreign body She got lump in throat, hives in mouth, no cardiopulmonary sx. We gave her epi
68 2021-01-10 impaired work ability "out sick" for 48 hours
68 2021-01-10 sensation of foreign body 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 2021-01-13 anxiety Tufts of my hair came out by the handful - first time in my life I have experienced ANY hair loss! ... Read more
Tufts of my hair came out by the handful - first time in my life I have experienced ANY hair loss! It is still ongoing and I am worried it will result in permanent baldness.
68 2021-01-13 confusional state Patient received her first dose of Moderna vaccine on 1.12.2021. Approximately 4 hours post-vaccinat... Read more
Patient received her first dose of Moderna vaccine on 1.12.2021. Approximately 4 hours post-vaccination she reports being suddenly weak, confused, and sweaty. She is a retired RN, took her HR, which was 108 (patient reports it is normally in the 50-60's) and BP was 123/57 (normally higher in the 130/70-80 range). Patient does report she had difficulty speaking and may have had difficulty breathing. Patient took 2 baby aspirins "in fear that it may have been her heart." Patient states that it took around 1 hour for the "episode" to pass. Patient states that she did not seek emergency care in fear of catching COVID. Instructed patient to call PCP to ask about appropriateness to receive 2nd vaccine. Patient states that she will and will request an epipen from her PCP as well. Patient encouraged to seek emergency care if a similar situation arises again.
68 2021-01-13 impaired work ability Nausea, vomiting and diarrhea. Clear liquid diet. Rest. No work for two days. When lab returne... Read more
Nausea, vomiting and diarrhea. Clear liquid diet. Rest. No work for two days. When lab returned normal, Lomotil taken for the diarrhea on 12/29/2020.
68 2021-01-19 sensation of foreign body Patient reported an itchy throat and like she had something in her throat. Endorsed having trouble s... Read more
Patient reported an itchy throat and like she had something in her throat. Endorsed having trouble swallowing. Patient reported dizziness and headache which subsided. EMTs took set of vitals, remained stable and within normal limits. Patient still reporting throat itchiness. Liquid Benadryl given (20 mL -- 25 mg). Patient had occasional dry cough that subsided. Vitals retaken at 1350. Throat itchness subsided and patient left.
68 2021-01-20 disorientation Patient was sitting in chair waiting for the 15 minute observation time, about 3 minutes after injec... Read more
Patient was sitting in chair waiting for the 15 minute observation time, about 3 minutes after injection patient started convulsing, patients husband lowered patient to floor and myself and another nurse rolled patient to her left side, seizure lasted approximately 2 minutes , patient awakened and was disoriented and approximately a minute later had another seizure lasting one minute. EMS was called and arrived but patient and husband refused transport to ER.
68 2021-01-20 feeling abnormal About 2 hours after injection, I experienced chills, fever, cough, body ache, site pain was red and ... Read more
About 2 hours after injection, I experienced chills, fever, cough, body ache, site pain was red and swelling. I had muscle ache throughout. I called in sick. My left arm symptoms lasted about 5 days. After the swelling went down, I continued with body aches, fever and cough. I tested negative for COVID on the 30th. My husband tested positive on the 3rd and my job advised me to test again on the 5th and I was positive. Around the 10th, until 2 or 3 days ago, I've had SOB with exhaustion and brain fog. Three days ago, I had a tele appt with and received antibiotics. I now have sinus infection, secondary to COVID.
68 2021-01-20 loss of personal independence in daily activities, feeling abnormal I started noticing about an hour 1 and 1/2 later, I had chills. I was extremely achy with pain throu... Read more
I started noticing about an hour 1 and 1/2 later, I had chills. I was extremely achy with pain throughout my body. I felt like I was getting a bad case of the flu. I was very lethargic. The site itself was inflamed and warm. I couldn't function, so I went to bed and let my boss know I was having some sort of reaction. From that point I wasn't well. I eventually tested positive for COVID and now I have a sinus infection. The swelling at the site started to go down about 5 days later and my symptoms we residing as well for my arm itself. I still had body aches, fever, cough, brain fog, respiratory and sinus issues. I also had intermittent mild nausea. Symptoms were alleviated about a week ago. I still have symptoms, but they are residual. I was on antibiotics prescribed by Dr. via Telemed.
68 2021-01-23 anxiety Developed extreme facial redness which was very warm to touch. Also lips were tingly and somewhat n... Read more
Developed extreme facial redness which was very warm to touch. Also lips were tingly and somewhat numb feeling. I felt very anxious which is not typical for me, I have had several other vaccines with no reaction in past. I had left the facility following 15 minutes of monitoring and took off my mask in the car. I looked in mirror because my face felt so warm. My husband was with me and symptoms did not worsen so we went home which only took 10 minutes and after another 30 minutes it did not subside so I took a low dose of liquid Benadryl. This eventually relieved my symptoms. I took another low dose at bedtime also. I slept through the night and had no further problem the next day. Thus I did not contact a physician or the facility.
68 2021-01-25 euphoric mood "extremely fatigue" and "feeling high".
68 2021-01-25 sensation of foreign body severe stomach cramps beginning on 2nd day (shot Thurs - Sat discomfort) after receiving 1st dose o... Read more
severe stomach cramps beginning on 2nd day (shot Thurs - Sat discomfort) after receiving 1st dose of vaccine. Began with stomach cramping and 'lump in throat' continued until severe cramping in stomach going up windpipe into throat. In bed 2 full days now beginning to recover (3rd day and hoping). Could not belch or fart wind out of stomach. Drinking or eating caused pain.
68 2021-01-25 sleep disorder 16 hours after the injection, I was awakened with needing to vomit. I had only clear liquid which I... Read more
16 hours after the injection, I was awakened with needing to vomit. I had only clear liquid which I coughed out. I was having difficulty catching my breath and unable to burp or clear the liquid. After three tries, I was able to clear the airway and was able to breathe well. I also checked my blood pressure which was 163/83. I had phlegm in my throat and could clear it with drinking water. After approximately 40 minutes of checking and rechecking my blood pressure and drinking water, I was able to sleep until 9:00 am. It is now 24 hours from the injection and I feel much better.
68 2021-01-26 feeling abnormal Extreme sore arm after vaccine that went down. Then 7 days later, same area covered with bumpy rash... Read more
Extreme sore arm after vaccine that went down. Then 7 days later, same area covered with bumpy rash like welts. Still hard. The area is below the injection site. Otherwise, feel kind of low flu-ish. Felt fine first week. Then on day 7 rash and feeling off. Maybe an immune response.
68 2021-01-26 sleep disorder very sore arm (can't sleep on right side or move arm much) headaches
68 2021-01-27 anxiety 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 2021-01-29 impaired work ability I had at least 101 fever, chills, my left arm ached with pain and I could barely move it. At one poi... Read more
I had at least 101 fever, chills, my left arm ached with pain and I could barely move it. At one point, it felt like all of the roots of my teeth were in pain at once. I had to miss two days of work and I slept most of the time. I took Advil to reduce the fever
68 2021-01-30 sleep disorder 3 days after the vaccine I had 3-4 days of breast pain that made it difficult to even sleep. That s... Read more
3 days after the vaccine I had 3-4 days of breast pain that made it difficult to even sleep. That subsided, then I had persistent itching at the injection site. That subsided but now have large, hard red patch the size of a tangerine at the injection sight that is slightly itchy and tender. Have been experiencing slight nausea on and off, mostly in the mornings. Six days after injection I was feeling light-headed, dizzy and like I was just going to faint or fade away. Still have those symptoms on and off, but they are not as strong.
68 2021-01-31 amnesia 103 temp, projectile vomiting, hard chills, nausea, headache, joint pain, unable to stand without fa... Read more
103 temp, projectile vomiting, hard chills, nausea, headache, joint pain, unable to stand without falling, no memory of most of day. Arm is still very red, swollen, painful & is moving down my arm
68 2021-01-31 confusional state new onset confusion, fever, diarrhea
68 2021-02-02 disorientation, feeling abnormal 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 2021-02-06 insomnia 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 2021-02-06 loss of personal independence in daily activities, impaired work ability Awoke day after receiving vaccination feeling lightheaded and nauseous. Felt faint and had to lie do... Read more
Awoke day after receiving vaccination feeling lightheaded and nauseous. Felt faint and had to lie down. Began to experience headache and chills as the morning progressed. Could not work or care for grandchild that day. Started to resolve by next morning.
68 2021-02-07 amnesia 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 2021-02-07 anxiety, feeling abnormal 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 2021-02-08 confusional state Fatigue Apathy Unusual tiredness Body aches Headache Accelerated pulse Confusion
68 2021-02-08 sleep disorder Patient awakened in the morning with pain and swelling in the right knee with marked tenderness late... Read more
Patient awakened in the morning with pain and swelling in the right knee with marked tenderness laterally and local swelling in the same area. Over the next 12 hours she developed a moderate synovial effusion of approximately 20 cc with pain in the knee becomeing generalized and had trouble walking and decreased range of motion consistent with the effusion. . The pain seemed to subside somewhat later in the day but she still had trouble walking. On the second night of 2/6/2021 she was able to sleep but had continued discomfort, swelling and difficulty walking on 2/7/2021. The pain became even worse during the night of 2/7/21 and she was unable to sleep. In the early morning she took 5 mg hydrocodone and got some relief.. She continued to have pain and swelling through the day. By the evening of 27/21 she was somewhat better. The morning of 2/8 21 she awakened with less pain, less effusion, and was able to walk better. She slept well that night. On the morning of 2/9/ she awakened with no pain. The effusion was gone and the knee felt stiff but no longer was painful. By afternoon she was walking without pain and complaining of slight stiffness. The only other side effect was pain at the injection sight for 2 days which was mild to moderate. The R knee never felt warm and was never red. . I have an infrared camera and the temps recorded on the right knee were no higher than the left knee. No other joints were involved and she had no recent right knee injury. No chills, fever, nausea or other problems. No headache, No myalgias. No vision or auditory prob.ems. The sense of smell remained normal. She is my wife and I was considering getting a CBC, Sed Rate, C-reactive protein and possibly an arthrocentesis and evaluation of the fluid. Since she improved markedly and quickly no tests were done. I will report any follow-up problems. It just seemed very strange to have a painful swollen joint with no redness or warmth that was fairly severe and then almost totally resolve within 24 hours between the 3rd and forth day. .
68 2021-02-09 sleep disorder I had the first COVID vaccine on 1/30/21. The shot itself was painful, and afterward the site of the... Read more
I had the first COVID vaccine on 1/30/21. The shot itself was painful, and afterward the site of the shot was painful and I could not move my arm without pain. The pain was intense to the point that I could not sleep well that night. Could not lie on my left side because of the pain caused by pressure on the arm. The pain gradually went away within 48 hours of the shot. Today, 2/10/21, 11 days after the shot, the area around the injection site, over 2 inches in diameter, is still red and inflamed. There is no pain.
68 2021-02-10 fear I woke up at 3:30 a.m. February 11. I noticed I had wet the bed (which I haven't done for 60+ year... Read more
I woke up at 3:30 a.m. February 11. I noticed I had wet the bed (which I haven't done for 60+ years) and felt very weak--afraid to move for fear I would pass out. I had no pain and no indication of heart attack or stroke. After 5-10 minutes I walked to the bathroom where I had diarrhea and vomited a small amount. I stayed on the stool for some time because I felt too weak to safely get up. I did go back to bed after 15 minutes or so. I got up again with diarrhea an hour or so later. I got up at 9 a.m. feeling a lot better but still weak. Took it easy the rest of the day and had regained most of my energy by evening. I think I may have suffered a seizure of some kind resulting in the wet bed and extreme weakness.
68 2021-02-10 memory impairment Headache for 3 days, cognitive problems that lasted for 2.5 weeks. I would frequently drop items he... Read more
Headache for 3 days, cognitive problems that lasted for 2.5 weeks. I would frequently drop items held in my hands, had difficulty typing on a keyboard, had problems with tasks such as sewing , doing crossword puzzles and remembering things. For example, for many years I would do the crossword puzzle in ink and be able to complete it. During this time, I could only finish about 1/3 of the puzzle and then give up in frustration. Another example: I have been using a Nutribullet to grind coffee beans once a week for years. I had trouble assembling it for use. I tried to screw on the top having it face the wrong side. I could tell this was not correct but it took a minute to figure it out. I did not seek treatment since these things seemed subtle and I did not think clearly enough to think of that option! The symptoms have slowly resolved over a 2.5 week period. I will not get the 2nd dose because of this reaction.
68 2021-02-11 feeling abnormal Arm sore as expected after injection. First vaccine only sore arm. Second dose on 2/11/20 very sor... Read more
Arm sore as expected after injection. First vaccine only sore arm. Second dose on 2/11/20 very sore arm then around 1:30am i woke up with chills a fever of 100 and body aches which continued all day on 2/12/21. I still feel kind of blah but nothing I can?t handle at this time.
68 2021-02-12 feeling abnormal Got a headache immediately and a strange feeling all the way down my arm to my fingers. A health pro... Read more
Got a headache immediately and a strange feeling all the way down my arm to my fingers. A health professional can to check my vitals ... every thing was fine, except for my blood pressure. As the day went on , my headache became more severe. I took one Advil upon arriving home , and another one at bed time. The next day I felt fine except for pain all the way from my head to my feet on the right side of my body... my head , my jaw, my throat, arm , leg and foot. The next day the rest of the pain went away, except for my head and my eyes. My eyes feel like someone punched them. They still hurt , I have a headache and feel very tired.
68 2021-02-12 feeling abnormal pATIENT STATED HER TOP LIP FELT KINDA FUNNY. DID NOT NOTICE ANY SWELLING
68 2021-02-12 excessive sleepiness 1st shot, no reaction other than sore arm. Then 2 weeks to the day of injection, my injection site... Read more
1st shot, no reaction other than sore arm. Then 2 weeks to the day of injection, my injection site developed a hot red rash, it lasted 5 days. After second shot I was VERY sick the next day with sore arm, headache, nausea, weakness symptoms and a 100.4 temp. Slept all day, ate nothing till 6 pm, then started to feel better. Seemed Ok the next day (Thursday) except a little weakness and sore neck. On Friday still a sore neck. On Saturday still a sore neck and a bit of headache then I noticed a lump in lower neck area around the clavicle which is very sore. That is where I am today 021321.
68 2021-02-12 irritability Red splotches on right arm below injection site starting with large circle, now goes down much of up... Read more
Red splotches on right arm below injection site starting with large circle, now goes down much of upper arm. Very itchy. Also, extreme irritability.
68 2021-02-13 agitation Red, firm lump at injection site with itching and pain. First presented about 36 hours following in... Read more
Red, firm lump at injection site with itching and pain. First presented about 36 hours following injection. Lasted about 3 days, with mild itching forabout 3 days. All symptoms returned on day 7 after injection with larger diameter red, sore and swollen lump. Significant pain at the site and in shoulder and intense itching. Noticed lymph nodes in armpit of the injected arm were sore on days 7 and 8. Feelings of agitation primarily due to itching. Also notice a couple of small raised pustules around injection site. I am currently on day 8 so cannot report on the outcome of this event.
68 2021-02-15 feeling abnormal I had mild pain and itching in my arm the evening of the day of the vaccine (02/12). The next mornin... Read more
I had mild pain and itching in my arm the evening of the day of the vaccine (02/12). The next morning I woke up feeling awful, I had a fever of just over 100 and chills, vomiting and diarrhea, body aches and a medium headache. This lasted the full day. I couldn't eat or drink anything...kept coming back up and out... really awful. When I had Covid-19 back in March although I had a fever for 10 days, I had none of these symptoms... I just lost my sense of taste and smell for 7 months.
68 2021-02-15 insomnia 1. Left side of face became partially numb while driving home from pharmacy-lasted 20-30 minutes. ... Read more
1. Left side of face became partially numb while driving home from pharmacy-lasted 20-30 minutes. 2. Insomnia returned as well as some nausea and pain left, back of head during the night.
68 2021-02-17 depressed mood, suicidal thoughts 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 2021-02-17 sleep disorder At bedtime, both arms ached, slept poorly, got up several times during the night. In the morning, wo... Read more
At bedtime, both arms ached, slept poorly, got up several times during the night. In the morning, woke with a headache, lightheaded, dizzy, knew I would not be able to drive safely. By afternoon, felt somewhat better.
68 2021-02-18 insomnia At 11:20 PM, I was about to go to bed when I started to get cold on my hands. Then I became cold al... Read more
At 11:20 PM, I was about to go to bed when I started to get cold on my hands. Then I became cold all over and had worsening chills throughout the night. I could not get warm despite lots of blankets and clothing. I was shivering all through the night until about 5:00 AM. I did not sleep well at all I woke up not feeling well, with my both hip joints aching. That is unusual for me. I have a low-grade fever and am very tired. No chills at this time. This in addition to soreness at the injection site.
68 2021-02-19 hallucination Hallucinating by hearing things falling doors opening throughout her house when no one is living wit... Read more
Hallucinating by hearing things falling doors opening throughout her house when no one is living with her.
68 2021-02-20 anxiety, nervousness, feeling abnormal 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 feeling abnormal Moderna COVID-19 Vaccine EUA I got the 2nd Vaccine on February 19th. When I got the 1st vaccine on ... Read more
Moderna COVID-19 Vaccine EUA I got the 2nd Vaccine on February 19th. When I got the 1st vaccine on January 22, 2021 and after 8 hours I began to feel nauseated and it progressed into what I remember feeling when I had COVID-19 in November. I was sick all night and at 12 noon it lifted and I felt normal. When I got the 2nd shot on February 19, 2021 again I go ill around dinner time but this time it has lasted into the third day. It started off feeling like I felt when I had COVID-19 for the first day. Day 2 and 3 I feel like I have the flu. The severe aches and pains are gone but I feel stuffiness and very lethargic.
68 2021-02-21 delirium In about 12 hrs I felt fevered, then went to cold, then I started trembling. So hard, I still felt... Read more
In about 12 hrs I felt fevered, then went to cold, then I started trembling. So hard, I still felt cold, but this wasn?t shivering, I wanted to go to get in warm water. I was shaking so bad I couldn?t take my clothes off. I got in with clothes on, I was getting delirious. My whole body was contracting so hard I couldn?t sit in the tub flat, my but cheeks contracting with all muscles. I found myself in the night with a sticking hat soaked in water to cover my face. I could not have called for help when the muscle contractions were going on. That lasted I think 30-45 minutes. I was groggy on the 20th all day but getting much better. I was very excited for vaccine and would do it again, but wanted to report what I consider pretty rough side effect, so you could make note of it. And I still thank you for the vaccine, but dang I truly thought I was dying.
68 2021-02-21 sleep disorder After receiving the shot at 9:00 a.m., at 6:00 p.m. I started to feel very tired and as if I was get... Read more
After receiving the shot at 9:00 a.m., at 6:00 p.m. I started to feel very tired and as if I was getting a fever. By 9:00 p.m. I was shaking from chills (despite being bundled up under a blanket), so I took my temperature -- it was 100.5 degrees orally. My normal temperature on that thermometer is 97.6 degrees. That night, I kept waking up every two hours or so and was very uncomfortable. THe next day I felt very lethargic -- unable to do anything other than make myself something to eat. I took two naps, one in the morning, and the other in the afternoon (that was about two hours). I felt slightly better by around 8 p.m. That night I slept somewhat better and felt myself break into a sweat during the night -- so I guess that is when the fever broke. The next day (today) my temperature was back to normal and I feel okay. Throughout the now three days, the arm where I got the shot was painful, but gets less so each day.
68 2021-02-22 confusional state Patient received vaccine around 6pm and had some swelling in her ankle around 9pm bilateral. States ... Read more
Patient received vaccine around 6pm and had some swelling in her ankle around 9pm bilateral. States she thought the inside of her cheek was swollen but thinks it doesn't feel any different now than it did then and think she was just in her head about it. She forgot to take her BP meds that morning and took them the following day and swelling in her ankles went down within 24 hours.
68 2021-02-22 confusional state #1 Moderna vaccine 1/22/21 @1210hours at right deltoid Date of second shot was not recorded for rep... Read more
#1 Moderna vaccine 1/22/21 @1210hours at right deltoid Date of second shot was not recorded for report 2nd vaccine caused side effects started the next day - woke up feeling very weak, headache, eyes hurting, fever not measured, felt confused, dizzy, vomited x2
68 2021-02-22 depressed mood Felt severely depressed for at least 5 hours --completely resolved when she awoke the next morning.
68 2021-02-22 feeling abnormal 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 feeling abnormal Discomfort at injection site immediately, Started running a low grade temp at 24 hrs in the 100.+*, ... Read more
Discomfort at injection site immediately, Started running a low grade temp at 24 hrs in the 100.+*, with the highest being 100.6. Temp lasted for 12 hrs, with chills & again weird nausea. Experienced headache from 24 hrs for 36 hrs that could be controlled with Aleve.
68 2021-02-22 insomnia severe pain and stiffness left arm and around travelling down to forearm, cannot comfortably positio... Read more
severe pain and stiffness left arm and around travelling down to forearm, cannot comfortably position left arm in any position, cannot type, cannot sleep due to pain .
68 2021-02-23 insomnia Insomnia 1 night, no appetite 48 hours, terribly sore mouth 72 hours, shortness of breath 24 hours
68 2021-02-23 sleep disorder 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 2021-02-24 excessive sleepiness Fever of 100+, aches, no appetite, lots of sleep.
68 2021-02-24 insomnia 3 hours after injection extreme pain in the muscle of my left shoulder. Can not raise my arm withou... Read more
3 hours after injection extreme pain in the muscle of my left shoulder. Can not raise my arm without extreme pain. (on a scale of 1-10, this is about an 8). Just a little sore when touched. Sleep last night was very difficult. Still painful to raise my arm this morning, still at least a 7.
68 2021-02-25 anxiety 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 sleep disorder At 10:15 p.m. I experienced extreme bodily cold that no matter how many blankets I put on, the coldn... Read more
At 10:15 p.m. I experienced extreme bodily cold that no matter how many blankets I put on, the coldness persisted throughout the night. I was not able to sleep all night. I had a low temperature (100 degrees)
68 2021-02-26 feeling abnormal Elevated liver function tests. Patient only very rarely uses alcohol or tylenol. Last alcohol use ... Read more
Elevated liver function tests. Patient only very rarely uses alcohol or tylenol. Last alcohol use was one year ago. She does not take any unlisted supplements. No other potential hepatotoxins identified.
68 2021-02-26 nervousness 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 feeling abnormal, disturbance in attention 1) Fatigue: I slept more than 11 hours the night of getting my shot. I usually sleep 7 hours (1 day)... Read more
1) Fatigue: I slept more than 11 hours the night of getting my shot. I usually sleep 7 hours (1 day) 2) Extreme upper arm pain, visibly swollen with a "hard" feeling knot of muscle underneath (2 days) 3) Arm that was extremely hot to the touch and very itchy (2 days) 4) "Foggy" brain, unable to clearly focus (1 day)
68 2021-02-28 sleep disorder, loss of personal independence in daily activities, feeling abnormal Approximately 6 hours later, fever, chills (teeth chattering), mental blurriness, had to go to bed, ... Read more
Approximately 6 hours later, fever, chills (teeth chattering), mental blurriness, had to go to bed, tossed and turned all night, sweating, next day the same, and symptoms lasted from severe to moderate until the next night, and today, two days later, still feeling not quite "here." Put off working out for yesterday and today, because I was kind of pummeled from this. No one else had these issues, among the people I know. I would like to get me back and hope tomorrow is better.
68 2021-03-01 sleep disorder I woke 15 hours after 2nd dose of Moderna with violent shaking and chills, fever and headache. Fever... Read more
I woke 15 hours after 2nd dose of Moderna with violent shaking and chills, fever and headache. Fever was 100.8. I took Tylenol it brought it down. I had to take Tylenol every 4-5 hours the next day or the fever returned. The fever and bad headache lasted 24 hours. The chills and shaking stopped within 2 hours of first being awoken by them. 48 hours after the vaccine I developed a redness on my arm about an inch from the injection site. It grew in diameter to 4 inches. It was very hot to the touch and itchy. Today is day 6 from getting the vaccine and it is finally starting to fade and is not hot to the touch today. I am assuming it will disappear with a day or two. I researched on the computer and saw that it is being called "covid arm". I did not seek any medical attention knowing that the vaccine could cause these issues.
68 2021-03-02 excessive sleepiness Around 3PM is started feeling nausiated, Then I became extremely cold and could not get warm for abo... Read more
Around 3PM is started feeling nausiated, Then I became extremely cold and could not get warm for about 3 hours. After that I slept for 14 hours, got up shower. After being up about 4 hours I slept another 3 hours. I was not hungry. Actually food upset my stomach. I still felt somewhat ill until I got up the 2nd day. I am fine now.
68 2021-03-02 insomnia Headache, fever, body aches, fatigue, nausea, insomnia
68 2021-03-02 mental status changes Patient was being monitored post-vaccine for 30 minutes. At approximately the end of her monitoring... Read more
Patient was being monitored post-vaccine for 30 minutes. At approximately the end of her monitoring period, the patient C/O of extreme "sleepiness." Stated it was hard for her to stay awake. Altered mental status.
68 2021-03-03 disorientation 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 2021-03-04 impaired work ability 3/2/21 @ 3:45 pm - covid moderna shot #2 received in right arm. 3/3/21 - 3/5/21 Severe side effe... Read more
3/2/21 @ 3:45 pm - covid moderna shot #2 received in right arm. 3/3/21 - 3/5/21 Severe side effects experienced -- could not go to work or do normal activities. Tired, fever, chills, sweating, nausea, vomiting, diarrhea, sore arm/muscle pain, headache, "covid arm". "Covid Arm" after dose 1 on left arm and again after dose 2 on right arm. Note: I am still recovering but answered "yes" to item 20 below; not back to normal yet.
68 2021-03-04 loss of personal independence in daily activities Severe fatigue and all over body aches, had to lay down for 8 hours before resuming daily activities... Read more
Severe fatigue and all over body aches, had to lay down for 8 hours before resuming daily activities. No fever, no nausea or vomiting.
68 2021-03-05 sleep disorder Immediately after the injection (2/17/21) I had no noticeable symptoms except a tiny bruise appeared... Read more
Immediately after the injection (2/17/21) I had no noticeable symptoms except a tiny bruise appeared at the injection site. Then, about a week after the injection (Thurs. 2/25/21) I developed a red rash (approx. 2" X 4") at and extending below the injection site. Plus my arm began aching. Rash and aching worsened for the next two days through Sat. 2/27/21. I took ibuprofen Sat. evening in order to sleep. By Sunday 2/28 the aching had mostly subsided and the rash gradually faded by 3/2.
68 2021-03-06 abnormal dreams 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 2021-03-06 feeling abnormal, sleep disorder This was my second COVID shot. My arm hurt badly the night of the shot. I woke up in the middle of ... Read more
This was my second COVID shot. My arm hurt badly the night of the shot. I woke up in the middle of Thursday night/early morning with chills. Couldn't stop shaking. I couldn't lift my arm past my waste. Felt awful on Friday and I ended up running 101.8 fever. I had a headache that day. The fever finally broke on Saturday and I just felt weak and my arm still hurt. Today, Sunday, I suddenly have a big bright rash at the injection site on my arm, 6"x3". During the first one my arm hurt terribly, felt flu-ish, very low grade fever and ended up with "COVID arm" a big rash 8-9 days later at site of injection.
68 2021-03-06 insomnia Insomnia sleeplessness
68 2021-03-07 confusional state, feeling abnormal, feeling drunk Injection at 1:45 within 10 min.just felt weird like off alittle . waited my 20 min. by the time I w... Read more
Injection at 1:45 within 10 min.just felt weird like off alittle . waited my 20 min. by the time I walked to the car I was the same maybe a little more ..walking slow. by the time I got home 15 more min... I was feeling really woozy... glad to be home.. I felt fine & happy.. except for the woozy feeling and started feeling loopy...like I had drank a couple drinks..Not thinking correctly..This lasted for at least 4 hrs then less for 2 hrs.. then I went to bed . woke up the next morning foggy headed ,,till about afternoon. along with a verY sore arm and a huge lump at the inj site ..also it did hurt when I got it..both the needle and going in. The soreness left after 2 days the bump took longer. And I still have a bruise where I got it. I did learn 1 thing,,DO NOT TEXT AFTER THE SHOT if you feel like this,,,,, didn't make much sense at all..And I didn't remember half of what I said till the next day and reread it,, ..Like texting while drinking...ugh. but I didn't feel bad except for my arm and little headache. I googled and saw where others had the same feeling ...loopy woozy after .
68 2021-03-07 feeling abnormal Client states a 4x6 inch red reaction. States this reaction started 3/5/2021. Reaction was not ra... Read more
Client states a 4x6 inch red reaction. States this reaction started 3/5/2021. Reaction was not raised. Hot to touch. Itchy. Resolving starting today. 3/4/2021 - Also felt like was "hit by truck" for a couple days.
68 2021-03-07 feeling abnormal Described earlier, see previous page
68 2021-03-07 excessive sleepiness, incoherent Moderna COVID-19 Vaccine EUA No fever, but very incoherent for several days, sleeping 12-14 hours ov... Read more
Moderna COVID-19 Vaccine EUA No fever, but very incoherent for several days, sleeping 12-14 hours overnight, then snoozing in chair for most of the day; eyes were extremely sore, burning, stomach distressed, a bit of diarrhea, arm was stiff, red and sore at point of injection, all over joint stiffness and achiness. These symptoms slowly improved, but lasted at least 5 days. Redness and itchiness at point of injection returned on Saturday, 3/6, still red and itchy today 3/8. Eyes also burning again.
68 2021-03-07 excessive sleepiness Headache, Arm swollen with heat and redness, chills, sleeping, diarrhea. Not feeling well for 3 day... Read more
Headache, Arm swollen with heat and redness, chills, sleeping, diarrhea. Not feeling well for 3 days. Arm still painful with redness on day 4.
68 2021-03-07 panic attack, anxiety Evening of March 3rd, convulsive chills extreme fatigue, dizziness. Morning of March 4th, collapsed ... Read more
Evening of March 3rd, convulsive chills extreme fatigue, dizziness. Morning of March 4th, collapsed on bathroom floor after feeling nauseous. Very weak and very hard to push to standing position. Eye infection which I treated with hot compresses. I infection almost gone today March 8th. Teeth sensitivity, anxious and panicky, dizzy very tired, headache, swollen glands in neck, too dizzy to drive.
68 2021-03-07 poor quality sleep Didn't sleep well Thursday night-restless. Friday morning arm was slightly sore. Around noon, began ... Read more
Didn't sleep well Thursday night-restless. Friday morning arm was slightly sore. Around noon, began feeling achy all over, very tired, got bad chills and had fever (99.3). Legs hurt when I walked. Knuckles on both hands very sore, unable to lift anything heavy or twist anything. Oxygen was 97, heart rate 74 and BP was 132/72. Saturday woke up with pounding headache, knuckles on right hand still hurt. Slept better but woke up with red splotches/rash around injection site. Itchy, warm to touch and sore when pressed. Sunday, rash still there and still tired. Monday knuckles still sore on right hand, not so bad on left. Rash seems to be going away, but area still warm to touch and sore.
68 2021-03-08 sleep disorder 7 days after vaccination developed fasiculations in Left deltoid muscle for several hours - enough t... Read more
7 days after vaccination developed fasiculations in Left deltoid muscle for several hours - enough to keep me awake No other known reason for these.
68 2021-03-09 anxiety 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 2021-03-09 insomnia sore arm, fever, body aches, body chills, fatique, sleeplessness lasted 30 hours
68 2021-03-09 sleep disorder I already had a sciatica flareup and pain at time of vaccination but about 8-10 hours after 2nd dose... Read more
I already had a sciatica flareup and pain at time of vaccination but about 8-10 hours after 2nd dose I experienced increased and very severe muscle pain in the same area (back of left thigh and down left leg) that night and into the next afternoon, to the point of being awoken from sleep and to tears. It was back to normal by the next evening without treatment other than Tylenol and Ibuprofen. (Pharmacist advised me to report my symptoms.)
68 2021-03-10 anxiety, feeling abnormal This is my second report. I have continued to have traveling headaches, tingling, nausea, joint pai... Read more
This is my second report. I have continued to have traveling headaches, tingling, nausea, joint pain, intense fatigue and brain fog. I now have constant tinnitus and am having my hearing checked next week because I feel I have hearing loss. The fatigue is debilitating. I start to feel better and another wave hits me. I was advised by my doctor to not take the second dose. The tinnitus is getting louder. It causes anxiety. I don?t know how I am going to live with it.
68 2021-03-10 incoherent 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 nervousness 1/8 12:00 vaccination 5:30 I started to notice my body was itching. No rash marking the skin. Itchin... Read more
1/8 12:00 vaccination 5:30 I started to notice my body was itching. No rash marking the skin. Itching progressed, made me nervous because I am allergic to other things and its the same symptoms. As my temperature would change slightly, no fever, but elevated for me I feel uncomfortable. Persisted into the week. Made appt with my immunologist. Put on weeks worth of antihistamines; night and day. It did help and gradually help. The itching lasted for quite a while, 2nd dose was recommended to take a antihistamine before vaccination. No itching with the second dose. RASS test in a month
68 2021-03-10 sleep disorder Symptoms started Tuesday evening with aches and slight headache. During the night the headache beca... Read more
Symptoms started Tuesday evening with aches and slight headache. During the night the headache became excurciating, fever went up to 100.3, aches got worse, became nauseated. Took Tylenol. Arm was so sore I could not lay on it while sleeping. Could not sleep well, up every hour or so. In morning still have symptoms, very fatigued. Fever finally dissipated and symptoms lessened then found I had loss of taste. About 6:00 fever started again. By Thursday my symptoms were gone, but still have fatigue.
68 2021-03-10 sleep disorder 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 2021-03-11 excessive sleepiness Extreme tiredness. Slept all day the next day. Fine the following day.
68 2021-03-11 excessive sleepiness 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 loss of personal independence in daily activities Two adverse events: 1) Sharp pain and burning feeling in entire left shoulder appeared on 3/2/21 in ... Read more
Two adverse events: 1) Sharp pain and burning feeling in entire left shoulder appeared on 3/2/21 in the evening. Couldn't move my left arm at all without sharp pain. Had to keep arm in position like it was in a sling for about 15 hours. After 15 hours could move it slightly, but couldn't lift arm, button shirt, lift milk carton. Each day, it improves slightly and I can move it more. But today, 3/12/21, it still isn't back to normal and there are still sharp pains if I make the wrong move. 2) Large red oval patch on left arm appeared on 3/5/21 in the evening. It was slightly swollen with itchy bumps (like poison ivy) for about 12-15 hours. After that, itch and swelling were gone, but a flat red patch remained for about 3 days.
68 2021-03-11 sensation of foreign body c/o "something is stuck in my throat". benadryl 50 mg im given by MD's order
68 2021-03-11 sleep disorder 48 hours after vaccine extreme pain. Dr. Called treated with ice, Advil. Hydrocodone Apap started ... Read more
48 hours after vaccine extreme pain. Dr. Called treated with ice, Advil. Hydrocodone Apap started 3/20/21. Orthopedic surgeon on2/25/21, cortisone shot, X-rays....ice with a shoulder hardness. No relief, extreme pain, not able to sleep more than a couple hours a night. 3/27/21family dr office, oxycodone acet makes me vomit, no relief. 2/28/21 dr office again, steroid shot in hip...relief for 24 hours. Then pain returned. 3/1/21 another long acting steroid shot...no relief, still extreme pain! 3/3/21. Physical therapy. 3/4/21 dr office for steroid shot again...little relief, not long lasting! 3/5/21 Methylprednisolone, slept for 4 hours that night, Eased some durning the day...no relief at night. 3/10/21. MRI, on shoulder.
68 2021-03-12 feeling abnormal The first day I was a little achy and blah feeling then later in the evening I had a little headache... Read more
The first day I was a little achy and blah feeling then later in the evening I had a little headache with it, into the night I had a low grade fever. The next morning I had flu symptoms so I took acetaminophen every six hours, drank a lot of water,and rested throughout the day. Next day the body pain and chills are gone but still feel tired.
68 2021-03-12 feeling abnormal Abdominal red rash warm to touch ( NO itching or blistering) Centerline Neck red rash warm to touch... Read more
Abdominal red rash warm to touch ( NO itching or blistering) Centerline Neck red rash warm to touch (NO itching or blistering) It developed approximately 28 hours after 2nd Covid-Moderna vaccination. I also was sick to my stomach, achy and very fatigued. Slept most of that day. Next day the rash was larger in area and more inflamed. Benadyl 25mg taken @ 1pm and 9pm that day. Also at 9pm H2 blocker and Ibuprofen 400 mg taken before bed. By day 3 rash on my abdomen was gone but still had rash on neck. As of today it is gone.
68 2021-03-12 insomnia Fever, chills, headache, nausea, muscle aches, joint aches, arm swollen and sore. Started 11 hours ... Read more
Fever, chills, headache, nausea, muscle aches, joint aches, arm swollen and sore. Started 11 hours after shot and still ongoing in the morning. Not much sleep. Tylenol bringing fever down.
68 2021-03-12 sleep disorder Itching on left arm below injection site. Followed by a Red slightly raised area. Itches unpleasant ... Read more
Itching on left arm below injection site. Followed by a Red slightly raised area. Itches unpleasant and the combination of the itching & red raised area makes sleeping uncomfortable
68 2021-03-12 sleep disorder I have been fine except for tenderness in the injection site the first 2-3 days and up until 03-11-2... Read more
I have been fine except for tenderness in the injection site the first 2-3 days and up until 03-11-21 when I began having an itch in the site of the injection which I kept noticing until bedtime. Then, yesterday, 03-12-21, I noticed that the site was warm to the touch and there is a red rash around the site along with swelling/a tight lump in the site, sensitivity as well as continuation of the itching. Avoided sleeping on the site due to tenderness. Upon waking today, 03-13-21, attention was drawn to the site because of the itch and sensitivity; the lump also seems to be a bit bigger. I did sign up with the v-safe site this morning to follow-up. Not sure of next step....
68 2021-03-13 feeling abnormal 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 nervousness, impaired work ability 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 nightmare, sleep disorder I had no response to the first vaccination but I had read enough in the news to know that my respons... Read more
I had no response to the first vaccination but I had read enough in the news to know that my response to the second was not uncommon. After the second vaccination, my arm became very sore during the day. When I went to bed at 11pm, I was unable to sleep for about 45 minutes because I was shivering and unable to stop. I added additional clothing and finally managed to stop shivering and sleep. My sleep was restless all night, with bad dreams, a headache, and neck pains. My watch indicated that my sleeping heart rate was higher than average throughout the night. After showering at 7am and forcing myself to carry on, I felt better later in the morning and all symptoms were gone.
68 2021-03-13 sleep disorder In the evening, I guess around 9 p.m., after I filed last report vac site started itching with pain... Read more
In the evening, I guess around 9 p.m., after I filed last report vac site started itching with pain and hardness and swelling in area around shot site, that had practically disappeared over previous two days, suddenly increased a lot (on your scale it would be halfway). At 3 am March 11 the itching was so severe it woke me (would be near the top of your scale). Also an arthritis reaction Type 3 delayed serum allergy was quite noticeable in joints. I took Benadryl and an hour later a prednisone tablet from a bottle that expired three years ago. Neither symptom worsened after that and were better in the morning and diminished over the next couple of days. Except the following two evenings the significant itching around vaccination site returned around 9 pm (but not as bad as the scary 3 am episode). I didn?t take anything else for it by mouth, but I put some triamcinolone acetonide over the area of the shot and that stopped the itching enough to sleep. Arm soreness continues but is minor.
68 2021-03-14 feeling abnormal Moderna COVID-19 Vaccine EUA At ~10 minutes into my 15 minute "observation" period post vaccine, I b... Read more
Moderna COVID-19 Vaccine EUA At ~10 minutes into my 15 minute "observation" period post vaccine, I became extremely dizzy and weak; feeling as if I would fall out of my chair. I gripped the chair with both hands and put my head down between my knees. 2 EMTs that were on-site came over and talked to me; put me into a wheel chair and took me to their "tent" area in the gym and had me lay down on a cot. They kept me under observation (completing blood pressure, heart rate, pulse-ox, and temp monitoring) for ~1 hour/15 minutes. I was somewhat recovered, and wanted to go home. They told me I should contact my doctor for evaluation before returning for the second dose, scheduled for 4 weeks out. An EMT walked me to my car. I drove myself home. I continued to experience continuous (but milder) dizziness and weakness for the rest of the day, mostly recovered by the following morning. (I also experienced typical side effects of soreness at the injection site, starting later that first day; and mild headache and fatigue the following day).
68 2021-03-14 insomnia sore arm temperature extreme fatigue sleep
68 2021-03-14 sleep disorder I've had fiibromyalgia since I was a teenager. I have more fatigue than pain now. Starting the nex... Read more
I've had fiibromyalgia since I was a teenager. I have more fatigue than pain now. Starting the next morning after the vaccines, I had a horrible headache especially in my forehead and upper neck. I very achy, much more than normal, my arm was very sore. My temperature usually runs about 97.1 and during the night it spiked to 99.1. I also had no appetite. It takes a lot for me to realize I don't feel well because I don't feel that great anyway, but I definitely did not feel well. I slept very little that night. By the next morning I felt much better and was back to "normal" by midafternoon.
68 2021-03-14 sleep disorder Began having headache 3hrs after injection, nausea, dizziness, generalized aching began approx. 4 h... Read more
Began having headache 3hrs after injection, nausea, dizziness, generalized aching began approx. 4 hours post injection, worsening throughout afternoon and evening, low grade fever - 99.4, unable to eat or sleep through next am with symptoms decreasing during day after injection. Resolved 48 hours post injection. Extra Strength Acetaminophen decreased discomfort slightly.
68 2021-03-15 feeling abnormal 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 excessive sleepiness Very sore red swollen arm, down to the bend in elbow. Sore and sensitive eyes. all over ache and ... Read more
Very sore red swollen arm, down to the bend in elbow. Sore and sensitive eyes. all over ache and the flue like feelings. did not feel well. I slept alot of 3 days two nights with fever and chills. This is day 5 my arm is still slightly red and itches.
68 2021-03-15 poor quality sleep Day 1 after injection redness of arm and sore, with headache Day 4 after injection swelling of both ... Read more
Day 1 after injection redness of arm and sore, with headache Day 4 after injection swelling of both tops of feet up to ankle, with dark red/purple coloration under skin (like bruising). Not on toes, only top of feet and around ankle. Felt hot like sunburn. Some itching. Subsided after 2 days. (by Day 7). Day 5 after injection, very restless sleeping, tossing and turning.
68 2021-03-16 confusional state Confusion - vasovagal reaction. BP 131/62 (pulse 69), O2 sat 98%.
68 2021-03-16 feeling abnormal, nervousness Five minutes after the shot I felt lightheaded and funny. Then my heart started to beat hard. It di... Read more
Five minutes after the shot I felt lightheaded and funny. Then my heart started to beat hard. It didn't last too long and by the time I told the nurse she checked my pulse and said it was strong but normal. They watched me for 30 min. I felt better, but ever since then I have had flutterings of the heart. I called my doctor who said it was nerves and to take the second shot. About ten days later I went to Urgent care who did a electrocardiogram and said it was normal, they didn't catch the flutterings. They told me it was nerves and to take the second shot. 14 days after the shot I took Claritin D which seemed to calm the heart. I am taking it every day now, until I'm sure the flutterings are gone. I'm pretty sure I had an allergic reaction and I will not be taking the second shot unless you can assure me I should. I called my doctor again and was told they weren't seeing sick people, go to a heart specialist, although they didn't recommend one.
68 2021-03-16 feeling abnormal 15 days after 1st shot I had a dizzy feeling when I got up in the morning. It passed after about 40-... Read more
15 days after 1st shot I had a dizzy feeling when I got up in the morning. It passed after about 40-45 min but then today it again happened and a "off" feeling lasted for about 90-120 minutes. This is not normal for me.
68 2021-03-16 feeling drunk Dizziness at night. When getting out of bed felt like I was drunk. Lasted one day and then 4 days ... Read more
Dizziness at night. When getting out of bed felt like I was drunk. Lasted one day and then 4 days later the same thing. Then on the 5th day the same thing. Seems better the next day.
68 2021-03-16 nervousness I had a very bad case of Covid last March. I received my first vaccine March 3 of this year. I got... Read more
I had a very bad case of Covid last March. I received my first vaccine March 3 of this year. I got a temperature of 103 degrees, I was nourish , my muscles, Joints and bones hurt so much I couldn't lift myself out of bed without extreme pain. The chills I got made me literally shake. My arm where I was given the shot, I couldn't lift it. Even the other arm hurt bad. My mouth hurt, my teeth hurt, my gums bleed for four days after and the teeth hurt too for that length of time. My stomach was itchy but no rash. I felt like I had the virus again minus other issues I had when I did have it. I'm scheduled to receive my second dose March 31 and I'm very very nervous about it. I don't think people who had the virus, especially those who had it very bad like myself, should get vaccinated. It took 2 weeks to recover from all the pain. HELP!
68 2021-03-16 sleep disorder Moderna Covid-19Vaccine With-in 3 hours of my second shot, I could not lift my arm which lasted for... Read more
Moderna Covid-19Vaccine With-in 3 hours of my second shot, I could not lift my arm which lasted for two days. Although my range has improved, it has been almost 2 weeks and my left arm/shoulder hurts, aches, and is still painful. It interrupts my sleep. (This was a different experience from the 1st Moderna shot.) Treatment includes ice/heat, advil, and a massage.
68 2021-03-16 sleep disorder metallic taste in mouth, headache , can't sleep, nausea, diarrhea, loss of appetite, little stren... Read more
metallic taste in mouth, headache , can't sleep, nausea, diarrhea, loss of appetite, little strength, fever, chills . fever gone
68 2021-03-17 depression all very bad: dizziness , headache, pain in all joints, tired, depression worse than usual.
68 2021-03-17 feeling abnormal Diarrhea for 4 days, not able to eat more than crackers and pedialyte, no energy, very tired. The s... Read more
Diarrhea for 4 days, not able to eat more than crackers and pedialyte, no energy, very tired. The stools there were was very dark and still continuing to have loose dark stools. Felt like I was in a fog.
68 2021-03-17 restlessness pain on right side, didn't feel well, nauseated, restless, overall doesnt feel well
68 2021-03-18 depression 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 2021-03-19 insomnia sleeplessness with chills all night Woke up the next morning 3/19 with a fever of almost 103 and he... Read more
sleeplessness with chills all night Woke up the next morning 3/19 with a fever of almost 103 and headache Took 2 advil and put a cold cloth on my head Temp went down in about an hour and was normal by evening Very fatigued but only slept about 2 hours the night of 3/18 Feeling much better now just alittle headache and tire easily
68 2021-03-19 loss of personal independence in daily activities When I arrived home approximately 5pm, a headache so bad felt I was hit hard with a bat in the front... Read more
When I arrived home approximately 5pm, a headache so bad felt I was hit hard with a bat in the front lobal area, was numb. Arm at injection site was painful, hurt to lift arm, stung and burned. Total body began to slow down with painful aches all over,, especially across both back of shoulders which now was painful to lift either arm.Moaning and struggling to walk. Difficulty using the toilet. That evening I was leaning back in my chair and experienced a tightening of the throat like waving up and down both sides of my throat, struggling to get air. Nausea. 2nd day same as 1st. 3rd day Dizzy, nausea, throat relaxing. Day 4 headaches, throat r e laxing more.
68 2021-03-19 sleep disorder Severe body aches, unable to sleep, headaches, weak, no appetite and 101 fever at day 3 of onset. Th... Read more
Severe body aches, unable to sleep, headaches, weak, no appetite and 101 fever at day 3 of onset. Then left arm swelling, itching, raised red area at injection site on day 11. Not painful. Symptoms have subsided by day 12.
68 2021-03-19 sleep disorder 11 days after the vaccine, I experience excruciating neck pain that went from the right side of my n... Read more
11 days after the vaccine, I experience excruciating neck pain that went from the right side of my neck to the left side and back to the middle. I had a small fever 100.8 I could not sleep for four nights due to pain
68 2021-03-20 feeling abnormal 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 sleep disorder 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 2021-03-21 anxiety Patient c/o nausea, Vital signs BP 140/81, RR 16, HR 99, spO2 97%. Patient felt anxiety after 2nd do... Read more
Patient c/o nausea, Vital signs BP 140/81, RR 16, HR 99, spO2 97%. Patient felt anxiety after 2nd dose of vaccine. Physical exam unremarkable. Patient felt better and able to go home.
68 2021-03-21 anxiety anxious, headache, dizziness, BP high, transfer to ED
68 2021-03-21 confusional state severe headache, severe dizziness, fatigue, and feeling of confusion. neurologic changes seen on e... Read more
severe headache, severe dizziness, fatigue, and feeling of confusion. neurologic changes seen on exam include jerk horizontal nystagmus, dysmetria, and other imbalance
68 2021-03-21 feeling abnormal After the first inoculation I had some transient pains in my head, and a few hive like welts, some t... Read more
After the first inoculation I had some transient pains in my head, and a few hive like welts, some tiredness. Then I had the second inoculation. The morning of 3/11/21 I woke up sweating with a fever and this very strange feeling was rolling through my body, from my head, down to my toes, then back up to my head and on and on. I took my temperature and it was 100.5 F. Also, I had begun breaking out in a few hive-like red welts on my legs, arms, stomach, back, maybe 8 to 10, hard to tell, but strange looking, unusual, and uncomfortable. Then around that Wednesday, the 16th, my urine was brownish and smelled smoky. I had not taken any supplements in days. The next day it was beige, smoky, then the next day bright yellow. The next day it went back to normal. More welts. EXTREME exhaustion. Then on the 18th I developed chills and more itching and welts. One on my face. One or two on my scalp. More around my waist, arms, neck, and legs. I am still having intermittent chills and hives/welts, and EXTREME tiredness. I have a cold sore in my mouth or throat, I can't tell exactly where.
68 2021-03-21 nervousness, insomnia 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 2021-03-23 disorientation 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 feeling abnormal Got the vaccine, and about 24 hours later she started to feel an ache in her front left tooth. She ... Read more
Got the vaccine, and about 24 hours later she started to feel an ache in her front left tooth. She was wondering if this was due to the vaccine or not. She was unable to lift her arm as well. In a couple of hours it was real sore and she kept hitting it with her tooth. Her upper gum was then tender and could not touch it. She then could not chew on the front left tooth, and even hurt with touching of her tongue. As the night progressed more teeth were tender, and the lip was also more tender. She started to get a headache and then all of her joints were starting to hurt. The next morning, Friday morning she had no energy at all, just felt terrible. Her face was now swollen, as well as her upper lip. That night it was getting worse adn worse and her gums were so itchy and all the teeth on the left side felt loose. It then reached her jaw and then the swelling went to her eye. She called her PCP, and put on antibiotics, to take a antihystamine and a steroid. Told her to go to the ER if it did not gete better. It was horrible by Monday morning, she went to UC and had an abscess in her tooth. They put her on penicillin, told her not to take the other antibiotics. By Tuesday morning the swelling had gone down, and the swelling in the gums were also gone, and the teeth were also better. The abscess was also feeling better. She had no issues with her gums and teeth prior to this. By the time she finished the penicillin she was fine. She went to the dentist and they could not find anything wrong with her, and informed her that it was proof that the vaccine was doing it's job.
68 2021-03-24 disorientation Initial symptoms of flu-like illness, cough, malaise, chills. One week later developed slurring of ... Read more
Initial symptoms of flu-like illness, cough, malaise, chills. One week later developed slurring of speech, gait instability, disorientation.
68 2021-03-24 feeling abnormal First night -Sat.-mild temp. 99.8 (my usual is 97.8), achy all over, sore arm. Next day- Sunday- 10... Read more
First night -Sat.-mild temp. 99.8 (my usual is 97.8), achy all over, sore arm. Next day- Sunday- 10Am, woke with the room spinning- dizzy, vertigo? Went away in a minute or two. During the day felt a little off, took shower, had dizziness again. Had to sit down in fear of falling over. Since then I have had slight bouts of minor dizziness. Just an unsure overall feeling that something isn't quite right. It is now Thursday, still feeling weird.
68 2021-03-24 feeling abnormal After first injection only had sore achy arm for few days About 4 hours after second injection on Fr... Read more
After first injection only had sore achy arm for few days About 4 hours after second injection on Friday morning, I started feeling bad with chills, then fever of 102-103; severe body and joint aches for a duration of roughly 48 hours; I just went to bed, By Sunday morning fever & chills had subsided, joint pain better, just very tired. Was able to return to work on Monday, and didn't need to contact my primary physician.
68 2021-03-24 panic reaction, anxiety 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 2021-03-24 sleep disorder Felt tingling in arm for first 10 minutes after shot. Arm extremely sore first 24 hours. Could not s... Read more
Felt tingling in arm for first 10 minutes after shot. Arm extremely sore first 24 hours. Could not sleep on it. Fatigued for first 24 hours as well.
68 2021-03-25 feeling abnormal Off feeling all day then arm began itching at the vaccine site, it was red puffy around site with a ... Read more
Off feeling all day then arm began itching at the vaccine site, it was red puffy around site with a rim.
68 2021-03-25 feeling abnormal Severe headaches, 5 days, fever, chills, on and off for first 3 days, nausea, 5-6 days, weakness, fa... Read more
Severe headaches, 5 days, fever, chills, on and off for first 3 days, nausea, 5-6 days, weakness, fatigue, 5-6 days, brain fog, 6-7 days, joint aches,6-7 days, dizziness and loss of balance, still have but not as severe , full body thrush, day 2-5. Extreme soreness at injection for 4-5 days
68 2021-03-25 sleep disorder pt states her left arm starting hurting late the evening after receiving the vax. She started to ge... Read more
pt states her left arm starting hurting late the evening after receiving the vax. She started to get cold and had fever. Her arm was sore and she could not sleep on her arm. She woke up this morning w/ 101.7 fever, achy. and loss of appetite. She took acetaminophen which would bring her fever down but when it wears off the fever goes back up. So far she has had two doses of acetaminophen. She feels some better and think she is improving.
68 2021-03-25 sleep disorder The delayed reaction began on March 24, 2021 in the early evening. My right arm (bicep and injectio... Read more
The delayed reaction began on March 24, 2021 in the early evening. My right arm (bicep and injection site area) began to itch and break out in a rash. I applied over the counter hydrocortisone and took a Chlorpheniramine Maleate 4 mg allergy tablet. The site continued to itch throughout the night and woke me up several times. Upon rising on March 25, 2021 I looked at my arm and the top of my shoulder and the rash had spread and there were large red hives that were hot to the touch, itching, swelling, and painful. I decided it was time to call my Dr. and make an appointment. I was not able to see him and was referred to his colleague. I went to see her at 11:30 a.m. She diagnosed the rash as a Moderna Delayed Reaction. She prescribed a prescription strength Hydrocortisone Cream to be applied3 times daily and Chlorpheniramine Maleate 4 mgs. since I am allergic to Benadryl every four hours. As of today, March 26, 2021 the rash has improved but still has the intense itch that travels down my arm and up.
68 2021-03-27 confusional state At 4pm patient states got facial drooping, increase in BP, and confusion
68 2021-03-27 loss of personal independence in daily activities Arm was sore where shot was given Saturday, 1:45PM March 6. Noticed slight muscle aches that afterno... Read more
Arm was sore where shot was given Saturday, 1:45PM March 6. Noticed slight muscle aches that afternoon. By 8PM those effects continued. I went to bed early and awoke in the night with extreme thirst and severe chills. I put on layers and heat was blasting near my head from below headboard. I had a fever of 104 degrees which went down soon after I removed layers. I recall being very hard to get out of bed when the chills were at their worst so I was in a fetal position to try to stay warm. Sunday, thirst, chills and fever were gone, but I had an intermittent headache, sore arm where shot was given and my other arm!, also muscle aches and tiredness. By Monday, I had muscle aches, tiredness and light-headedness; Tuesday I had slight nausea and headache a short while, but mainly tiredness. Wednesday, I still had soreness where shot was given, tiredness and light-headedness, but otherwise was feeling better. I canceled plans Thursday involving heavy physical labor (native plant restoration) just to rest a bit more. Basically, I had a bouquet of symptoms over several days - grateful not to have had all at once and can only imagine how bad coronavirus must be.
68 2021-03-28 feeling abnormal body aches and extreme fatigue. Was feeling bad but when I got up in the morning, it was over. Got C... Read more
body aches and extreme fatigue. Was feeling bad but when I got up in the morning, it was over. Got COVID arm/rash reaction 8 days later. It lasted 2 days. No treatments were used for either condition.
68 2021-03-28 loss of personal independence in daily activities Within seconds of receiving the vaccine, the injection site developed was huge almost baseball size,... Read more
Within seconds of receiving the vaccine, the injection site developed was huge almost baseball size, and it's still swollen up my arm to the base of my neck, I've had a fever, which is gone away, a rash, headache, chills, dizziness and weakness. I had to leave work because I couldn't work with the headache.
68 2021-03-29 impaired work ability Some up 14 hours after second dose cold and shaking uncontrollably. Progressed to fever, nausea, he... Read more
Some up 14 hours after second dose cold and shaking uncontrollably. Progressed to fever, nausea, headache and shortness of breath. Sweating. Nausea and fever subsided by 7 pm. Some up the next day still having a headache and shortness of breath. Could not work that day. All symptoms gone by 3 pm the next day.
68 2021-03-29 incoherent 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 2021-03-30 confusional state Got the vaccine and they had her pull over as she had already had a reaction to the first one. All ... Read more
Got the vaccine and they had her pull over as she had already had a reaction to the first one. All of a sudden she felt like her lip was swelling, and her tongue swelling, her face was a little red. She then had trouble breathing, and thought it may have been anxiety. She also has had headaches which have lasted for about 11 days, and depression. Her breathing was getting worse and the nurse came over and told her that she was having problems breathing and started coughing. She had Benadryl with her and she was advised to take that, and took 2 puffs of her inhaler. She stopped coughing as much, and was able to drive home within 10 minutes. She went home and realized that she was hyper, advised to take more Benadryl. It did not make her sleepy and did help with the allergic reaction. A friend saw her and told her that she was wired. She keeps having the coughing fits and breathing problems, and was thinking she was going into anaphylaxis. She also has had some confusion. She then went to the doctor on 3/25/21 due to urinary symptoms and had a UTI. Within the first couple of days she was having coughing bouts and was wondering if she should go the UC or not, wheezy type feeling. Her doctor gave her antibiotics and told her to use inhalers. She went back to the doctor on Monday 3/29/21, did a chest x-ray which was clear. She still thought that she was wheezy and ordered a new inhaler which she has been using, and still having coughing fits even today. She has been taking Benadryl every night since the vaccine which has not made her sleepy. The antibiotics seem to have helped the chest symptoms, but she is still coughing.
68 2021-03-30 confusional state Dizziness, slight confusion, lightheadedness severe wheezing (asthma attack) not relieved by rescue ... Read more
Dizziness, slight confusion, lightheadedness severe wheezing (asthma attack) not relieved by rescue inhaler, nausea and vomiting.
68 2021-03-30 excessive sleepiness No pain at time of injection at all. My arm started getting sore and painful to move after about 4... Read more
No pain at time of injection at all. My arm started getting sore and painful to move after about 4 hours. Then uncontrollable shivering,chills, fever, body aches, head ache, muscle spasms and pain, sore throat, extreme fatigue, nausea, loss of appetite starting about 7:00pm on the night of the vaccination and continuing all the following day (3/30) I took Tylenol and slept all day. Today, (3/31) some diarrhea, slight head ache, but all other symptoms are gone.
68 2021-03-30 insomnia Started a few hours post injection... Low grade fever, swelling on arm, nauseous, headache, coughing... Read more
Started a few hours post injection... Low grade fever, swelling on arm, nauseous, headache, coughing chills, sweats, not able to sleep. Still feeling effects 3 days post injection. developed large bump on arm near injection site.
68 2021-03-30 insomnia aching joints, extreme fatigue, head ache, fever of 100.9 all night, muscle cramps in left foot, not... Read more
aching joints, extreme fatigue, head ache, fever of 100.9 all night, muscle cramps in left foot, not able to sleep much because of headache, .
68 2021-03-31 anxiety Had headaches, anxiety and extreme exhaustion for 18 days following the vaccine.
68 2021-03-31 confusional state, feeling abnormal PATIENT REPORTS APPROXIMATELY 4 HOURS AFTER RECEIVING VACCINE - STARTED FEELING FUNNY. COULDN'T STAN... Read more
PATIENT REPORTS APPROXIMATELY 4 HOURS AFTER RECEIVING VACCINE - STARTED FEELING FUNNY. COULDN'T STAND UP, RAISE ARM, COMMUNICATE WITH FAMILY. FAMILY CALLED FOR AMBULANCE TO TRANSPORT TO HOSPITAL. PATIENT STATES SHE WAS UNAWARE OF HER SURROUNDINGS. NON-CONCLUSIVE RESULTS REPORTED.
68 2021-03-31 feeling abnormal High fever (102°), chills, extreme arm soreness, back & joint pain, severe headache, fatigue, feel ... Read more
High fever (102°), chills, extreme arm soreness, back & joint pain, severe headache, fatigue, feel terrible, sweating, out of breath when on feet, weakness
68 2021-03-31 insomnia, confusional state, amnesia 3 seperate fever blisters confusion/loss of memory elbow pain/ armpit pain extreme chills but no fev... Read more
3 seperate fever blisters confusion/loss of memory elbow pain/ armpit pain extreme chills but no fever congested nose extremely weak and tired nausea/vomiting abdominal pain off and on woke up with thick film to tongue,teeth and lips difficulty sleeping
68 2021-03-31 loss of personal independence in daily activities my skin on top of my feet burned, became hard and thick, my right big toe knuckle was prominent and ... Read more
my skin on top of my feet burned, became hard and thick, my right big toe knuckle was prominent and reddish, and my right foot swelled up so much it was difficult to walk and I couldn't wear shoes.
68 2021-04-01 feeling abnormal Very sore/heavy arm, redness, swelling at injection site, headache, extreme fatigue, body aches, br... Read more
Very sore/heavy arm, redness, swelling at injection site, headache, extreme fatigue, body aches, brain fog; no treatment except rest and fluids.
68 2021-04-01 insomnia Chills starting at 6:00 pm for 3 hours, severe ache in hips, shooting pain in knees Ended at 4:00 ... Read more
Chills starting at 6:00 pm for 3 hours, severe ache in hips, shooting pain in knees Ended at 4:00 am. Next day tired from little sleep. 2nd night shooting pain in knees x4 No other reaction after that.
68 2021-04-02 sleep disorder Very severe pain in left shoulder. Physician treated me at Urgent Care. He believes I had a blood c... Read more
Very severe pain in left shoulder. Physician treated me at Urgent Care. He believes I had a blood clot in the muscle. Injection site was one slim finger width below bone. Followed up at Orthopedic Clinic twice. MRI scheduled 4/5/21. Some tingling and numbness going down to hand and pain extending up from shoulder to neck and jaw. Unable to sleep on left side currently.
68 2021-04-03 nervousness Shot #2, Thursday, 4/1/21 8:20 am. 7 or 8 hours after shot: headache, chills, shaky, fever, nausea,... Read more
Shot #2, Thursday, 4/1/21 8:20 am. 7 or 8 hours after shot: headache, chills, shaky, fever, nausea, extremely tired, loss of appetite. Drank a lot of water and took Tylenol. Slept part of that night. Friday, 1st day after shot, slept much of that day, no appetite, slight headache. Saturday, 2nd day after shot, some discomfort in my left armpit? but felt better that day. Sunday, 3rd day after, still left armpit discomfort but overall feeling near normal. No need to get medical attention.
68 2021-04-04 feeling abnormal, disorientation 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 feeling abnormal, insomnia 12 hours after injection severe chills, sweating, fever, insomnia. Next day headache, loss of appet... Read more
12 hours after injection severe chills, sweating, fever, insomnia. Next day headache, loss of appetite, lethargy, brain fog. Symptoms resolved 36 hours after injection.
68 2021-04-04 sleep disorder I got the second shot on Friday afternoon April 2, 2021. Saturday night around midnight I developed... Read more
I got the second shot on Friday afternoon April 2, 2021. Saturday night around midnight I developed severe abdominal pain starting in the lower left and spreading across and up to just below the rib cage. The pain came in waves (like labor) where it rated a 10 out of 10. It was severe enough that I considered going to the emergency room. After about an hour I took some Tums hoping it would help. I tossed and turned for another two hours and then fell asleep. When I awoke the next morning the pain was gone. I thought this pain was unusual--it is not listed as one of the side effects. I had all the rest--low grade fever, muscle aches and pains, nausea and headache. Today, April 5 I am not in pain, but I am still a little wobbly and nauseous. Has severe abdominal pain been reported from a dose 2 of Moderna?
68 2021-04-04 sleep disorder I spoke with the nurse for the provider that saw the patient. The patient was seen in person by the ... Read more
I spoke with the nurse for the provider that saw the patient. The patient was seen in person by the provider on 3/30/21. She reported discomfort in the arm that began several hours after administration that originated in the area of the AC joint (patient pointed to that area during the physical exam). Patient reported discomfort across the shoulder that extended the length of her right arm into the tumb. Patient said the pain resulted in loss of mobility in the right arm and subsequent exhaustion due to inability to sleep comfortably overnight. Provider recommended Ibuprofen 200mg 2 tablets by mouth every 8 hours for 2 days and asked the patient to follow up with her in 24 hours. The patient spoke with the provider on 03/31/21 and reported an improvement in symptoms, increased range of motion and less pain overall.
68 2021-04-04 sleep disorder 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 2021-04-05 panic attack, anxiety 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 2021-04-07 feeling abnormal 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 2021-04-08 feeling abnormal Retuned home started to eat lunch had weird feeling in my neck.. lymphnodes enlarged and getting lar... Read more
Retuned home started to eat lunch had weird feeling in my neck.. lymphnodes enlarged and getting larger. Left side .then right Went to ER
68 2021-04-10 impaired work ability, feeling abnormal 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 feeling abnormal GOT SHOT AROUND 9:45 AM. STARTING FEELING BAD AROUND 9 OR SO THAT NIGHT. WOKE UP ABOUT 2:00 AM WITH ... Read more
GOT SHOT AROUND 9:45 AM. STARTING FEELING BAD AROUND 9 OR SO THAT NIGHT. WOKE UP ABOUT 2:00 AM WITH REALLY BAD CHILLS, HEAD HURTING REALLY BAD AND HURTING FROM HEAD TO TOES, NAUSEATED. THAT LASTED ABOUT 24 HOURS. ARM WAS VERY SORE AND STILL TO THIS DAY IT HURTS AT DIFFERENT TIMES.
68 2021-04-11 excessive sleepiness arm got a rash about 8 in. in diameter immediately after receiving her 2nd dose of Moderna. She was ... Read more
arm got a rash about 8 in. in diameter immediately after receiving her 2nd dose of Moderna. She was given an ice pack and waited 30 minutes in our observation area. I texted her at 5 PM and she said that her arm had "settled down after taking 50 mg of Benadryl-the reason being that my tongue was tingling!" On Sunday she texted, "I slept most of Sat. and had low grade fever, chills, and a bad headache. My arm feels better but is still hot to touch. Finally I have an appetite."
68 2021-04-12 amnesia, mental status changes 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 impaired work ability I not only had all side effects currently being reported as possible by the CDC but I had loss of sm... Read more
I not only had all side effects currently being reported as possible by the CDC but I had loss of smell for four days, pain in the lower back region of my lungs/my back area, extreme lethargy that lasted for two weeks, missed 2.5 days of work from the first vaccine & am experiencing the same side effects from the 2nd vaccine taken 4/8/21. I walk around like a drunk mam/woman/off balance, & my stomach intestinal issues are profuse. Both vaccines so now I know for sure that this vaccine has caused my digestive/intestinal issues. These issues linger on past 2 weeks from the first vaccine. I have missed 2 days of work from the 2nd vaccine shot & am currently experiencing profuse diarrhea & vomiting. I constantly burp. Fever, chills, body aches, headache. Congestion & some coughing to go with it. All the above & more. I have never suffered from any side effects from taking any other vaccine & I have had them all.
68 2021-04-13 confusional state 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 feeling abnormal 6 days after the second injection, suffered from severe vertigo, dizziness, nausea, headache and bra... Read more
6 days after the second injection, suffered from severe vertigo, dizziness, nausea, headache and brain fog. Was unable to focus. Lasted 10 days. Went to doctor twice and had MRI and MRA of brain, Carotid doppler scan, EKG. Checked for Epley maneuver. Fourteen days in and still off balance. Things are coming into better focus. Not as much brain fog.
68 2021-04-13 sleep disorder I ran a few errands after the vaccinaction and got home about 3:30pm. All of a sudden I began to fe... Read more
I ran a few errands after the vaccinaction and got home about 3:30pm. All of a sudden I began to feel hot and dizzy. Then the muscle aches started so I went to bed. But this time it didn't go away! Today is now 4/14/2021 and I am still having muscle ache in my right upper thigh and right side buttocks. It is lessening but it also keeps me from getting a good night's sleep. I've never had such a sensation. Even after my hip replacement surgeries I didn't have this kind of discomfort. I sure hope it ends pretty soon. For the past 2-3 years I have a routine of walking a minimum of 2 miles daily and that's during the winter as well since I'm up here in my state. I'm strong and I'll get over this but I never expected this. It feels like a "virus" has settled into the muscle tissue surrounding my right side hip implant. I keep walking and doing my other exercises but it's very tiring. Just wanted someone to know about this. And, no, I did not bother going to the doc's with this. Why would I? The 'brainwashing' of the past 30 years about not bothering to go to the doc's if you have a cold because it's a virus and there's nothing we can give you for a virus has really worked. I stay away from the doc's as much as possible!
68 2021-04-15 crying I received my second dosage of the Moderna vaccine March 17. A couple of hours afterwards I began ... Read more
I received my second dosage of the Moderna vaccine March 17. A couple of hours afterwards I began to cough without stopping for about 20 minutes. I later went to bed and during the middle of the night I felt so sick; my who body was on fire with great pain with a temperature of 104. The shoulder where the injection was taken had swollen so big. I couldn't move. I had my husband to take me to the bathroom and back and put me in the bed. Then later on in the morning I got the chills; I was freezing; my husband had covered me up tight with my thick bed jacket and I had on flannels; I was still cold. All day Thursday was the same thing. I wanted a bunch of icy cold water (I never drink cold water). The water helped. That night was the same so bad I began crying. I thought of going to the ER but wanted to see how the morning turns out. Around 5:00 am Friday morning I noticed the pain and the chills had ceased; by 6:00 am I really felt good. Whatever that was (side effects) Around 4 days later I developed the Covid Arm. Nasty redness, blueish, shoulder with rash and shoulder very painful and painful to touch. My could move my arm at all; the should was hard and stiff and felt exactly like after my shoulder surgery I had years ago. I followed up with my ortho doctor who told me that looking at my x-rays it looks as if the vaccine took an effect on my rotator cuff. She also stated that sometimes when given a shot, the provider should make sure the shot is given in a specific area and this time it may have hit my rotator cuff. She gave a shot of cortisone, I forget what she said was added also to it. My are began to move for use but I'm still not there yet. It still hurts and very painful if I trying moving my arm in certain areas, the shoulder bone cracks with each movement. I go to see another ortho surgeon on Tues 20th.
68 2021-04-17 sleep disorder Awoke with chills, severe leg cramps, painful muscles, severe frontal headache and nausea. Tried hot... Read more
Awoke with chills, severe leg cramps, painful muscles, severe frontal headache and nausea. Tried hot tub and massage. Able to tolerate but dependent on walker for toileting. Returned to bed. Perspired, chills, teeth chattering. Tried sips of water and vomited. Fatigue. Remained in bed until about 5:30 pm. Able to tolerate sips around 4 pm. Able to tolerate sips of water about 6pm. No appetite. Had chicken broth and water. Nausea lessened. Headache severe and unresolved with either asprin or Motrin. Returned to sleep about 11:30 pm and woke again around 4. Not chills or sweats. Mild headache. Injection site amd left deltoid painful to touch. Cannot sleep on side. Left side supra clavicular lymph nodes painful and swollen 10-25 mm .
68 2021-04-18 insomnia Patient had severe headache for 24 hours, sleepless night, fever (99 degrees F.) and chills (24 hour... Read more
Patient had severe headache for 24 hours, sleepless night, fever (99 degrees F.) and chills (24 hours after injection), and sore arm (both topically and under the arm pit). Headache, fever and chills were gone in 48 hours. Soreness in arm persisted 3 days.
68 2021-04-19 feeling abnormal Severe chills and tremors, high fever(102), joint pain, general aching and sensitivity, lightening t... Read more
Severe chills and tremors, high fever(102), joint pain, general aching and sensitivity, lightening type pain in head periodically, sharp stabbing pains in temporal and ear areas, persistent headache, fatigue and brain fog. Lasted about 19 hours. Fever and aches returned 4/17 night, then again 4/18 night. Side effects far more severe than my actual COVID symptoms.
68 2021-04-19 nervousness 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 2021-04-20 feeling abnormal Received Covid vaccine 4/2/21 at 1010 notes that by noon she felt a headache coming on and gradually... Read more
Received Covid vaccine 4/2/21 at 1010 notes that by noon she felt a headache coming on and gradually started to feel worse, with low grade fever of 99.0, wasn't concerned about that, but later around 0130 on 4/3/21 she felt very miserable, temperature 100.9, and felt a hot burning sensation starting slowing from the top of her head, down her face, slowly down both arms, down to tips of fingers, down both legs to her toes. She tried to stand up to go to the bathroom and had trouble walking, mentally knew what her mind needed to do, but visually was unable to see or make out objects, such as the shape of her glasses case. Her son had helped her to the couch to sit down. This episode had continued on until around 0330-0400 on Saturday morning lasting up to 2.5 hours. She ended up taking Motrin and the other symptoms of temperature, achiness, and headache slowly went away. No further noted issues to follow.
68 2021-04-21 depression 4 days after both vaccines, became extremely depressed for approximately 2 wks after each vaccine. ... Read more
4 days after both vaccines, became extremely depressed for approximately 2 wks after each vaccine. Just wanted to report definitely effected efficacy of my meds for Bipolar type 2
68 2021-04-21 sleep disorder Later that day my arm at the injection site swole and was so severly painful about 7pm I took Melox... Read more
Later that day my arm at the injection site swole and was so severly painful about 7pm I took Meloxican to help with the pain. Laid down but it woke me up during the night from the pain but over the next 3-4 days it began to fade away. On 4/10 it got massively swollen, painful and itchy. I rubbed it with alcohol,witch hazel and took more Meloxican for the disconfort. After about 3 or 4 days went down in size to about a pea size then all of the sudden it swole back up and I couldnt stand to touch it because it was so painful. Still to date I am still experiencing slight swelling, pain sensitivity and its still discolored and it feels as if a lump has developed across the bottom of it.
68 2021-04-23 amnesia 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 2021-04-23 feeling abnormal Pt had presented for #2 Moderna to observation area @1120 am via motorized scooter accompanied by he... Read more
Pt had presented for #2 Moderna to observation area @1120 am via motorized scooter accompanied by her daughter. @1130am pt was eating roasted salted almonds and taking home medications having conversations with daughter and staff. @1140 pt began to c/o left leg heaviness and "feeling different". Slight SOB. Pt was able to stand but w/labored effort worsened SOB and w/increased left leg heaviness and numbness-pt had slight slurred speech and c/o "feeling woosy". Pt took 2 Albuterol inhaler puffs 1144 911 called. Advised to take 2 Atrovent inhaler puffs also. @1145 AED obtained, BP 158/81 P 96 pulse ox 100%. 1158 EMS arrived and took over care, pt agreed for transport to nearest emergency facility, pt to be transported to GA AUC, daughter took personal belongings. Pt was AAOx3 entire vaccine and observation area visit time and at time of d/c.
68 2021-04-25 disturbance in attention Soreness, slight swelling, and rash at and around injection. Extreme fatigue, muscle aches and cramp... Read more
Soreness, slight swelling, and rash at and around injection. Extreme fatigue, muscle aches and cramping, sinus drainage, occasional headache, decreased ability to attend and concentrate. At this date, the symptoms in my left upper extremity have resolved. The other symptoms are still present mildly and occasionally.
68 2021-04-26 anxiety Nausea; Pt c/o nausea 15 mins after receiving vaccine. She denied chest pain, SOB, difficulty breath... Read more
Nausea; Pt c/o nausea 15 mins after receiving vaccine. She denied chest pain, SOB, difficulty breathing, or other complaints. Past med hx as reported by patient is carotid artery disease. Pt assessed and evaluated by NP and paramedic. Pt had mild anxiety, BP - 157/80.
68 2021-04-26 memory impairment 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 2021-04-27 feeling abnormal Cellulitis; head feels mentally in the fog; This spontaneous case was reported by a consumer and des... Read more
Cellulitis; head feels mentally in the fog; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cellulitis and Foggy feeling in head. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant) and FEELING ABNORMAL (head feels mentally in the fog). At the time of the report, CELLULITIS (Cellulitis) and FEELING ABNORMAL (head feels mentally in the fog) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. 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. Based on the current 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 had a huge rash and doctor diagnosed it as cellulitis which itched, burned and felt kind of achy. The same thing happened with flu shot. This case was linked to MOD-2021-086069 (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 2021-04-28 feeling abnormal Patient states she had a "weird reaction" and had generalized bone pain and " severe burning." She s... Read more
Patient states she had a "weird reaction" and had generalized bone pain and " severe burning." She states her symptoms also included headache and fever (does not know the temp) which lasted for one full day. States she took aceteminophen and that helped her some; she contacted her Oncologist and asked her to report those SE to us.
68 2021-04-29 sleep disorder 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 feeling abnormal, sleep disorder 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 2021-05-02 impaired work ability Headache, full, flu-like body ache: muscles and joints, nausea and lack of appetite, fever. I took ... Read more
Headache, full, flu-like body ache: muscles and joints, nausea and lack of appetite, fever. I took Advil and Tylenol. Was sick from the night of the injection on April 5 until about noon on April 7. Was unable to work (from home) on April 6.
68 2021-05-03 disorientation I had a nasty case of diarrhea I was also somewhat disoriented.
68 2021-05-03 feeling abnormal Started with aches and pains, low grade fever, coughing, nausea, vomiting , severe headaches, severe... Read more
Started with aches and pains, low grade fever, coughing, nausea, vomiting , severe headaches, severe neck pain, brain fog, sweat/chills, Low grade fever lasted 21 days.
68 2021-05-04 confusional state I HAD STROKE LIKE SYMPTOMS. I WAS CONFUSED. COULDN'T COMPLETE SENTENCES OR RECALL WORDS. THE SYMPTOM... Read more
I HAD STROKE LIKE SYMPTOMS. I WAS CONFUSED. COULDN'T COMPLETE SENTENCES OR RECALL WORDS. THE SYMPTOMS PERSIST.
68 2021-05-04 feeling abnormal, delirium 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 2021-05-05 sleep disorder 2nd-Moderna shot taken 05/03/2021 at 11:30 am. After 12 hours of injection, (05/04/2021) headache an... Read more
2nd-Moderna shot taken 05/03/2021 at 11:30 am. After 12 hours of injection, (05/04/2021) headache and fever began (12:15am). By 3:00 am, chills and fever of 102.0 F (my normal temp is 98.2 F). Took Tylenol every 4 hours. Due to Full body aches, headache and fever persisted until 8:00 am., unable to sleep all night. Stayed hydrated with water and Gatorade. Finally after 8:30am/ 05.04.2021, was able to sleep few hours. By 2:00pm/ 05/04/2021, chills and fever started second cycle... fever up to 101.5 F, this cycle. Body aches and headache persisted entire time. Fever broke approx. 8:00 -10:00pm. Was able to sleep most of the night. Headache, body aches and fatigue persisted all day 05/05/2021. Only able to eat soup, toast and Gatorade for 2 days. Fever and headache subsided around 10:00 pm/ 05/05/2021. Slept ok 05/05/2021 and 90 percent body aches subsided by 0506/2021. Moderate fatigue on 05/06/01, but able to regain daily routine.
68 2021-05-06 anxiety "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 2021-05-06 insomnia Positive test for Covid 19 one and one half month after receiving the second dose. Right eye has st... Read more
Positive test for Covid 19 one and one half month after receiving the second dose. Right eye has sty or what seems to be a cold in the eye. Pain in Right Shoulder and all down right arm. Pain is severe and wakes her up at night. This is well over one month of having the vaccine. No other incident or exercise could cause this pain.
68 2021-05-08 sleep disorder Evening of the shot -achiness, chills, fever, could not sleep - just tossed and turned all night, na... Read more
Evening of the shot -achiness, chills, fever, could not sleep - just tossed and turned all night, nauseous. Lasted about 12 hours. Next day, very tired, slept off and on all day and night - 24 hours Two days after the shot, I still felt tired, but much better. Three days after, I was just fine.
68 2021-05-09 confusional state 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 2021-05-12 feeling abnormal 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 2021-05-18 feeling abnormal Balance issues (falls), severe daily headaches (every day for 4-5 weeks), nausea, shakiness. After a... Read more
Balance issues (falls), severe daily headaches (every day for 4-5 weeks), nausea, shakiness. After a fall on April 4th, went to Urgent Care, general practitioner, eye doctor, dentist, and plastic surgeon (to drain a hematoma). Was prescribed eye drops, had no broken bones, no injuries to teeth, etc. After 3 weeks of severe headaches, went to long-time GP who gave a shot of Tramadol for pain. Headaches lessened for 2 days. On 5/13, another fall and extreme difficulty getting up. On 5/14, had issues with legs (no strength) and has been unable to get up from the toilet unassisted since. (Was previously walking 2-5 miles a day, 5-7 days a week, for the past 1.5 years.) Also, nausea, shakiness, jitters, balance issues, and mental fogginess all began on 5/13 and have been a consistent problem since. This caused the patient to go back to the Urgent Care on 5/18. Saw the same Nurse Practitioner as before, who suggested that we complete the VAERS form as she can see no reason why all these things are happening as tests show that the patient is healthy. Tested to see if there was possibly a urinary tract infection, but test came back negative. Suggested a neurological exam. Neurological, and heart tests were done late 2020 at the local Clinic; patient was given a clean bill of health.
68 2021-05-28 insomnia feels like her muscles and nerves are not working; "no strength when walking"; feels like her muscle... Read more
feels like her muscles and nerves are not working; "no strength when walking"; feels like her muscles and nerves are not working; She feels like her muscles and nerves are not working; She feels like her muscles and nerves are not working; right leg pain; cannot sleep; "legs give up on her"; feeling sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROPATHY PERIPHERAL (She feels like her muscles and nerves are not working) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart attack (Two previous heart attacks.). Concurrent medical conditions included Diabetes and Kidney cancer. On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced MALAISE (feeling sick). On 02-May-2021, the patient experienced NEUROPATHY PERIPHERAL (She feels like her muscles and nerves are not working) (seriousness criterion medically significant), MYOPATHY (She feels like her muscles and nerves are not working), PAIN IN EXTREMITY (right leg pain), INSOMNIA (cannot sleep), GAIT INABILITY ("legs give up on her"), ASTHENIA ("no strength when walking") and MYALGIA (feels like her muscles and nerves are not working). On an unknown date, the patient experienced NEURALGIA (feels like her muscles and nerves are not working). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (She feels like her muscles and nerves are not working), MYOPATHY (She feels like her muscles and nerves are not working), INSOMNIA (cannot sleep), GAIT INABILITY ("legs give up on her"), NEURALGIA (feels like her muscles and nerves are not working), ASTHENIA ("no strength when walking"), MALAISE (feeling sick) and MYALGIA (feels like her muscles and nerves are not working) outcome was unknown and PAIN IN EXTREMITY (right leg pain) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Per report, the patient did not experience any adverse events on the day of vaccine administration. On 02-May-2021, the patient experienced a persistent, unbearable pain in her lower right leg. She was scheduled to visit her doctor for treatment on 13-May-2021. Treatment included unspecified creams. 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. Myalgia is consistent with the product known safety profile.; 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. Myalgia is consistent with the product known safety profile
68 2021-05-31 feeling abnormal feeling miserable; did not take the second dose; feeling unwell; Vaccine attacked the ankles; Vaccin... Read more
feeling miserable; did not take the second dose; feeling unwell; Vaccine attacked the ankles; Vaccine attacked immune system; Throat was falling short; Anaphylactic shock; Vaccine attack on ankle; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) and IMMUNOSUPPRESSION (Vaccine attacked immune system) in a 68-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. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CALCIUM and FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) 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 ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant) and DYSPHAGIA (Throat was falling short). 14-Jan-2021, the patient experienced JOINT INSTABILITY (Vaccine attack on ankle). On an unknown date, the patient experienced IMMUNOSUPPRESSION (Vaccine attacked immune system) (seriousness criterion medically significant), FEELING ABNORMAL (feeling miserable), PRODUCT DOSE OMISSION ISSUE (did not take the second dose), MALAISE (feeling unwell) and ARTHRALGIA (Vaccine attacked the ankles). At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), IMMUNOSUPPRESSION (Vaccine attacked immune system), DYSPHAGIA (Throat was falling short), FEELING ABNORMAL (feeling miserable), MALAISE (feeling unwell), ARTHRALGIA (Vaccine attacked the ankles) and JOINT INSTABILITY (Vaccine attack on ankle) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not take the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 15 minutes after vaccination patient had anaphylactic shock with allergies and chronic hives. The patient was taken to emergency room for 6 hours. The patient was treated with unspecified intravenous 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.; 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 2021-05-31 loss of personal independence in daily activities Meniere's disease; not able to do anything; throwing up; Dizzy/ Light headed; sick; Cannot drive; Ea... Read more
Meniere's disease; not able to do anything; throwing up; Dizzy/ Light headed; sick; Cannot drive; Ear stuffed up; Ringing in Ear; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (Meniere's disease) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History reported. Concomitant products included LISINOPRIL, LEVOTHYROXINE and SIMVASTATIN for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced TINNITUS (Ringing in Ear). On 11-Mar-2021, the patient experienced EAR DISCOMFORT (Ear stuffed up). On 14-Mar-2021, the patient experienced DIZZINESS (Dizzy/ Light headed), ILLNESS (sick), IMPAIRED DRIVING ABILITY (Cannot drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to do anything) and VOMITING (throwing up). On 21-Apr-2021, the patient experienced MENIERE'S DISEASE (Meniere's disease) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Ear discomfort, at an unspecified dose and frequency. At the time of the report, MENIERE'S DISEASE (Meniere's disease), EAR DISCOMFORT (Ear stuffed up), DIZZINESS (Dizzy/ Light headed), ILLNESS (sick), IMPAIRED DRIVING ABILITY (Cannot drive), TINNITUS (Ringing in Ear), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to do anything) and VOMITING (throwing up) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was also provided treatment with a low salt diet and an unspecified diuretic. Based on the current 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 2021-06-02 feeling abnormal I had fever of 102, chills, headache, etc. I expected that. But I also had about five or ten minut... Read more
I had fever of 102, chills, headache, etc. I expected that. But I also had about five or ten minutes of total paralysis. I could not move. I could not lift my hand. Thankfully, it went away but I have been ?foggy? for the two and a half months since the second dose.
68 2021-06-07 feeling abnormal 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 2021-06-07 feeling abnormal Two weeks after the 1st vaccine I started having severe muscle and joint pain in my shoulder and pel... Read more
Two weeks after the 1st vaccine I started having severe muscle and joint pain in my shoulder and pelvic Areas. Within 24 hours of my second vaccine I experienced four hours of chills and malaise. This lasted four hours. My second vaccine was on April 16, 2021 in my left arm. the Vaccine was Madonna, lot number 043 B21A. two days after my second vaccine, my left knee became swollen to the point of being unable to bear weight. The shoulder and pelvic area pain continued to worsen and I began experiencing profound fatigue. I felt as though I had full body inflammation. The acute pain then extended into my right-hand where I experienced a sudden and spontaneous rupture of my thumb tendon which required surgery to repair. The rapture occurred why was sitting quietly doing nothing strenuous. I am being followed by a rheumatologist with a new diagnosis of polymyalgia rheumatica. My symptoms have been going on for over two months and they're quite debilitating.
68 2021-06-07 sleep disorder On 03-27-2021, did not feel well. I thought it was something I ate, felt very gassy. It progressed b... Read more
On 03-27-2021, did not feel well. I thought it was something I ate, felt very gassy. It progressed by Tuesday night, I was up all night with pain and cramping. I also noticed since receiving my Moderna vaccine I have noticed my arthritis flare up, my finger joints and hands tend to be more irritated and painful. I continue to have joint pain and stomach cramping . I also visited my PCP who gave me medication, Cipro and Flagil medication. I feel side effects are being under reported.
68 2021-06-09 disturbance in attention I have Lupus which has been pretty controlled, and I have never missed work. I have had some vision ... Read more
I have Lupus which has been pretty controlled, and I have never missed work. I have had some vision loss in the past. The vision loss has been controlled since 2017. The last time I had gotten a checkup was November of 2019. I saw my Ophthalmologist just before the second dose of the vaccine and there was some vision loss in my right eye. There was no change on the left. I went back to the eye specialist five weeks later. 05/03/2021 and 5/25/2021. I have had a flare up of Arthritis in my hip which started two weeks after the second dose of the vaccine. I was also diagnosed with Hypertension at the same time as my Arthritis flared up. I am supposed to walk with a cane now and I have been unable to work sometimes because appointments and my hip pain. I am having fatigue, difficulty concentrating which may be somewhat related to the medication for pain. I have had some medication changes to control my Lupus. Solumedrol and Cytoxan infusion therapy. I am getting Bactrim to offset the infusion therapy. Procardia and Prednisone increase and my Myfortic is discontinued. I also Simerinva eye drops for my eyes. I am getting Bactrim to offset the infusion therapy. It has been over ninety days now and My condition is still mostly the same.
68 2021-06-09 memory impairment -Unresponsive (blank stare); neurological - great difficulty walking (could barely move feet); Strok... Read more
-Unresponsive (blank stare); neurological - great difficulty walking (could barely move feet); Stroke-like symptoms < 24 hours of receiving the 2nd Moderna dose. -Taken to ER (PM - after-hours); Patient was admitted. -Testing battery included: MRI , both with and w/o contrast; CAT scan; blood work. -All testing results were within normal ranges. No evidence of stroke, heart attack, etc. -Discharged after 3 days. -Symptoms continue to happen intermittently. Some days patient displays a lack of cognition of her surroundings; impaired memory; cannot remember birthday, cannot sign her name, etc. Other days she displays more "normal" behavior.
68 2021-06-14 nervousness, impaired work ability, panic attack She got her vaccine, had no reaction at all. She woke up in the morning and had the hand shaking, ... Read more
She got her vaccine, had no reaction at all. She woke up in the morning and had the hand shaking, her body quivering and feeling like shew as having a panic attack and weakness, feeling like she had cerebral palsy. Everything aches but does not have a headache. She went to pharmacy as she had to leave work at 12:00 and her hands were shaking, and they told her that some people have that reaction. She cannot drive in this condition. Because of the shakiness she has to get up real slow and watch her steps. Says it feels like she has a mixer in her abdomen and that her whole body is shivering. She has had panic attacks in the past and feels like she is in one, but has not had them in a while, and nothing like this. They told her to take something for her body aches, headache, but the trembling is what is concerning her as she is not able to work like this. She is fearful of loosing her job as she cannot work like that and is afraid she cannot keep calling in. She is not able to drive in this condition either.
68 2021-06-14 panic attack, depression, anxiety 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 2021-06-20 disturbance in attention My lower back started to hurt, 102 fever, body aches, and chills. The next morning I was weak no app... Read more
My lower back started to hurt, 102 fever, body aches, and chills. The next morning I was weak no appetite and very light headed and couldn't concentrate. I go days with muscles weakness in my body since the shot.
68 2021-06-21 sleep disorder SEVERE PAIN AT INJECTION SITE UP ARM TO SHOULDER AND DOWN ARM TO ELBOW. WENT TO PRIMARY CARE AND OR... Read more
SEVERE PAIN AT INJECTION SITE UP ARM TO SHOULDER AND DOWN ARM TO ELBOW. WENT TO PRIMARY CARE AND ORTHOPEDIC DR. NEVER HAD ANY ISSUES WITH EITHER SHOULDER OR ELBOW. PAIN AT TIMES IS SHARP AND STABBING. WILL WAKE ME UP FROM SLEEP AT NIGHT. IT IS NOW OVER 60 SINCE SECOND INJECTION AND PAIN IS JUST AS SEVERE.
68 2021-06-22 crying So, it was sinus problems, stuffiness and discomfort. It was very mild symptoms and to be honest wit... Read more
So, it was sinus problems, stuffiness and discomfort. It was very mild symptoms and to be honest with you, I would not have even gotten tested except the contact tracing person told me to do so since my parents got COVID. My symptoms were not very bad, also had swollen glands. I was also dealing with my parents dying so I had a lot of symptoms from crying. The effects of crying were combined with the symptoms of COVID, and they were very similar. I only got the COVID test after the contact tracing person told me to go, she told me it was very important that I went. I got the test on May 27th, 2021 and it was positive so I did get COVID after my vaccine.
68 2021-06-30 depression - 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 2021-07-05 feeling abnormal 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 2021-07-05 excessive sleepiness Pt has swelling at injection site, it is warm to touch, and is about the size of golf ball and kind ... Read more
Pt has swelling at injection site, it is warm to touch, and is about the size of golf ball and kind of painful, patient is also experiencing fatigue and has cited sleeping almost the entire past 2 days.
68 2021-07-06 depression, confusional state 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 2021-07-07 feeling abnormal 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 2021-07-17 sleep disorder 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 2021-07-23 loss of personal independence in daily activities 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 insomnia GENERALLY NOT FEELING WELL, FATIGUE, CHILLS, FEVER, HEADACHE, NAUSEA, SORE THROAT, UNABLE TO HAVE FU... Read more
GENERALLY NOT FEELING WELL, FATIGUE, CHILLS, FEVER, HEADACHE, NAUSEA, SORE THROAT, UNABLE TO HAVE FULL ROM TO LEFT ARM, UNABLE TO SLEEP
69 2021-01-10 feeling abnormal Headache, off kilter, could not seem to wake up. Lasted all day about 24 hours after vaccine. Took M... Read more
Headache, off kilter, could not seem to wake up. Lasted all day about 24 hours after vaccine. Took Motrin and slept almost 24 hours. Body aches
69 2021-01-10 feeling abnormal About 9 hours after the shot my left arm suddenly hurt a great deal. I noticed it when I went to ra... Read more
About 9 hours after the shot my left arm suddenly hurt a great deal. I noticed it when I went to raise up my arm a little bit. I also became exhausted. I realized I had been tired much of the first day but once my arm became so painful, I was completely exhausted. I felt out of sorts for about 36 hours and then began to feel normal again. It probably took a few more days to regain my energy completely.
69 2021-01-10 impaired work ability Severe swelling of hand joints- especially the right hand. could not bend fingers. Heavy swelling of... Read more
Severe swelling of hand joints- especially the right hand. could not bend fingers. Heavy swelling of neck nodules, ears pain - heavy sweating-chills- heavy body ache- fever- heavy migraine type headache Pain of left arm -vaccine site- could not move/left arm for the last three days. Today is the fourth day, Monday, Jan. 11, and still having same symptoms unable to work.
69 2021-01-10 sleep disorder About 18-20 hours after the immunization I felt achy. At 6pm evening of the Jan. 8th I ached all ov... Read more
About 18-20 hours after the immunization I felt achy. At 6pm evening of the Jan. 8th I ached all over and temp. of 99.6. Took Tylenol 650mg and went to bed. Up and down most of evening / night, hot and cold, sweating and at 11pm temp. of 100.6 and took Ibuprofen 400mg. Miserable at 3:30am with temp. 101.4 and took Ibuprofen again. Slept well until 9:30am when I awoke with no temp. and feeling great. Temp.s were taken orally. Moderately sore arm. No nausea
69 2021-01-13 feeling abnormal, sensation of foreign body Was watched for 30 minutes, felt a little funny, but left the site after 30 minutes was up. got bare... Read more
Was watched for 30 minutes, felt a little funny, but left the site after 30 minutes was up. got barely down the road and had to pull over. Felt Flushed and hot around neck area and thought I might faint. Felt a slight lump in throat. Drove back to fair ground site and asked to be looked at. Symptons did not get worse and started to ease as Paramedics on site took blood pressure& cardiogram. Cardio was good and blood pressure was 178/81. Flushing disappeared, lump in throat 98% better. Refused further treatment and drove home, Was OK thereafter.
69 2021-01-13 loss of personal independence in daily activities, motion sickness, impaired work ability After the initial injection (1/11), there was just soreness at the site and no other problems. The ... Read more
After the initial injection (1/11), there was just soreness at the site and no other problems. The next morning (1/12), I woke with severe vertigo and ensuing nausea. I couldn't focus my eyes on any one point because everything seemed to quiver. The nausea was like motion sickness. I couldn't walk without stumbling. Since this was the first time I've ever experienced vertigo, it was concerning. I consulted my sister who is an RN who recommended the Epley Maneuver. It helped only a little, but I resigned to returning to bed to sleep to avoid the symptoms. The next day (1/13), I woke with vertigo again. It was not as bad as the first day, but prevented my activities (walking around the house, driving, working). Today (1/14) I woke feeling slightly queasy, but can function, but not work. If the resolution continues on this trajectory, I should be okay tomorrow, I hope.
69 2021-01-14 confusional state 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 2021-01-15 loss of personal independence in daily activities Noon-ish 01/15/2021 (4 days post shot), severe arthralgia, worse than her worst ever from Rheumatoid... Read more
Noon-ish 01/15/2021 (4 days post shot), severe arthralgia, worse than her worst ever from Rheumatoid arthritis, continues approx 24 hours later. Nearly incapacitated. Needs help to get up off couch to go to bathroom for example Evening of 01/15/2021, off and on chills, severe shaking Night 01/15/2021, fever up to 39.4 (103). Stayed above 101 for hours. Normal temp runs about 97.3. Fever running 37.3 on 01/16/2021 thru current (10:54a.m.) 01/16/2021, Arthralgia still present. Almost totally incapacitated.
69 2021-01-19 feeling abnormal 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 2021-01-21 feeling abnormal 1-20-2021 at 9:00pm i started getting cold, woke up the next day entire body and head aching. as day... Read more
1-20-2021 at 9:00pm i started getting cold, woke up the next day entire body and head aching. as day progressed it got worse, i could barely move and i had a temperature of 100.9. felt as bad in one day as i did with covid. by 6:00 am the next day i was find except for pain where i got the shot.
69 2021-01-24 depression, anxiety, sleep disorder, disorientation, abnormal dreams I received the injection around 2:30 I felt fine. It did not hurt going in. I stopped by a restauran... Read more
I received the injection around 2:30 I felt fine. It did not hurt going in. I stopped by a restaurant to get some take out and must of started feeling disorientated and completely forgot I had this folder with the VSAFE information. I started feeling chills all over my body, I kept taking my temperature it was 95.7, I started having a headache top of my head, the temporal, the back of my neck. They were all over the place. I went to bed and I couldn't sleep. It was like my brain was going crazy, it wasn't like an anxious feeling. I finally feel asleep around 4am and kept waking up remembering fragments of valid dreams. The dreams were fragment with such dread and anxiety in them. It was like a huge wave of depression and anxiety. By about 9am I was fully awake, but my body hurt, my muscles ached I felt fatigued. The chills and headaches were through. I was still having weird racing thoughts. About 10pm it all went away and I slept fine and woke up the next morning and I was fine. My arm is still sore at the injection site but all the other symptoms went away. Saturday morning I was talking with a friend on the phone, and she reminded me of the folder I received the folder. I completely forgot about this folder. I found this folder later that day and then I tried to access VSAFE. It made me realize how disorientated I was.
69 2021-01-25 amnesia, feeling abnormal 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 sensation of foreign body, nightmare 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 2021-01-27 nervousness 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 2021-01-28 excessive sleepiness Pt called on 1/29/2021 stating she had been sick since the night of 01/25/2021. Pt reports she slept... Read more
Pt called on 1/29/2021 stating she had been sick since the night of 01/25/2021. Pt reports she slept for 12 hours straight, woke up with extreme dizziness and could not walk without assistance, went back to sleep and slept for 5 more hours. When Patient woke up, she had shingles on her left lumbar/sacrum area, a headache and was nauseous. Pt called Doctor at ER and was prescribed Prednisone. Pt reports that her symptoms were very severe for 36 hours but she is feeling much better after taking the prednisone. Pt reports that she is still very fatigued.
69 2021-01-28 excessive sleepiness 1/17/21 L/Arm sore at injection site. 1/18/21 woke up during the night with stomach pain result -- ... Read more
1/17/21 L/Arm sore at injection site. 1/18/21 woke up during the night with stomach pain result -- loose bowel movement and stomach cramps. Started with severe chills, body shaking, achy all over, head felt like it was going to implode, started to sweat and felt flushed. Woke up my spouse to get me something to take for headache, etc. Later that morning could hard lift the Arm, felt a golf ball size lump at injection site and warm to the touch. Was in bed 2 days bcuz it exacerbated my MS. After that the injection site started itching, with redness. Lump finally getting smaller. I took a photo of the injection site which has a red circle the size of my hand.
69 2021-01-28 thinking abnormal Left arm soreness from 1600 1/26/2021 lasting till 1/28/2021 at 20000. On 1/27 extremely tired, chil... Read more
Left arm soreness from 1600 1/26/2021 lasting till 1/28/2021 at 20000. On 1/27 extremely tired, chills, nausea. Did not go to work. Foggy thinking. Highest Temp 99. On 1/28, able to go to work, continued tired, foggy thinking. Temp nl. On 1/29 able to go to work a little less tired. Arm soreness gone.
69 2021-01-29 depression, feeling abnormal, memory impairment, confusional state Evening of shot, sore arm and extreme fatigue. Following day, tired with ?brain fog?. Third day, b... Read more
Evening of shot, sore arm and extreme fatigue. Following day, tired with ?brain fog?. Third day, brain fog worsens, depression begins. Fourth day, confusion, withdrawal from interacting with others, worsening depression. Subsequent days, increasing confusion and severe memory problems. Becoming alarmed at inability to respond and ?find words?. By weekend, (5 days after shot) suicidal ideation, stopped talking to people (I live alone, but would regularly speak to neighbors and family prior to this episode). This rather alarming condition finally began to lift about 2days ago. I have a decades-long history of depression and have taken medication for it on and off since my 30?s. I must say I have concerns about getting a second shot next month because of the major depression as well as memory problems. ( I have been experiencing memory challenges for the last few years, and my Mom died of Alzheimer?s.)
69 2021-01-30 nervousness 9:05 PATIENT FEEL SHAKY. ATIENT SOME CANDY 9:15 PATIENT STATES SHE FEELS BTTER AND SHE IS NOT "SHAKY... Read more
9:05 PATIENT FEEL SHAKY. ATIENT SOME CANDY 9:15 PATIENT STATES SHE FEELS BTTER AND SHE IS NOT "SHAKY"
69 2021-01-30 sleep disorder I had the expected very mild soreness at the injection site for several days. The headaches came on... Read more
I had the expected very mild soreness at the injection site for several days. The headaches came on the night after the vaccine and have continued. Every night I get a headache with onset sometime between 1 a.m and 4:00 a.m. , making it difficult to sleep. The headache lasted all day on the 25th and 26th, but since then usually clears with morning coffee. Last night the headache started at 1:00 a.m. (earliest yet) and at 2:00 I took a Motrin and .125 g. Alprazolam and slept okay the rest of the night. Is this an interplay with my immunosuppression? I will eliminate the sleep time tea, but I honestly can?t fathom that would be a cause. Thank you for taking note of this and for responding if you can.
69 2021-02-02 sleep disorder My arm was a little sore during the day. When I went to bed at 9:00 pm, I started having non-stop un... Read more
My arm was a little sore during the day. When I went to bed at 9:00 pm, I started having non-stop uncontrollable rapid shaking in both arms, enough so that I could not stop the shaking for 3 hours unless I anchored my arms under my legs, and even that just decreased the amount of shaking.
69 2021-02-03 excessive sleepiness Reports sleeping more that normal (18-20 hrs first night), and sleeping more that normal past week.... Read more
Reports sleeping more that normal (18-20 hrs first night), and sleeping more that normal past week. reports fatigue, poor appetite some nausea. Dizziness that comes and goes.. Denies fever. States S/S have improved but still there after 1 week.
69 2021-02-04 disturbance in attention Dizzy,lightheadedness within minutes. Was told I could stay longer if needed but all they had was th... Read more
Dizzy,lightheadedness within minutes. Was told I could stay longer if needed but all they had was the same epipen that I had. Was taken home by daughter. Lightheadedness continued and some trouble focusing continued and desire to fall asleep. Took my bp ,it was 85/61.pulse 109.I hydrated with 3 bottles of water and ate olives to increase sodium level. an hour later bp was up to 107/67,pulse 67. I continued to monitor my bp through the next 24 hrs. I skipped my blood pressure meds for that night and continued with them the next day when my pressure was back to normal range. I did not use my epipen. Would have gone to ER if I was unable to control my hypotension. I am an RN.
69 2021-02-06 insomnia couldn't sleep, chills, aches, joint pain, headache; in morning, nausea, profuse sweating, loss of a... Read more
couldn't sleep, chills, aches, joint pain, headache; in morning, nausea, profuse sweating, loss of appetite, bad headache which lasted all day; didn't feel better until 2 days after shot
69 2021-02-07 disturbance in attention 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 amnesia Dehydration; Lost memory; Sore arm; Feels dizzy; Achy; Voice is hoarse; Fever; A spontaneous report ... Read more
Dehydration; Lost memory; Sore arm; Feels dizzy; Achy; Voice is hoarse; Fever; A spontaneous report was received from a consumer, who was a 69-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dehydration, fever, lost memory, sore arm, feels dizzy, achy, and voice is hoarse. The patient's medical history, as provided by the reporter, included some unspecified autoimmune issues. No concomitant product use was reported. On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient felt very dehydrated and ran a fever of 101.8 degrees Fahrenheit for which she took paracetamol. The patient reported she lost all memory from Friday, 22 Jan 2021. Her husband took her to the emergency room after not being able to hold anything down. She received two bags of intravenous fluids and was discharged home the following day on 23 Jan 2021. On 25 Jan 2021, the patient reported her arm was still sore, was dizzy and achy, and her voice was hoarse. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, dehydration, fever, and lost memory, was unknown. The events, sore arm, feels dizzy, achy, and voice is hoarse, were considered not resolved.; Reporter's Comments: This case concerns a 69 year old, female patient, with a medical history of unspecified autoimmune issues, who experienced serious unexpected event of dehydration and amnesia, non-serious unexpected event of pain in extremity, dizziness, pain, dysphonia and non-serious expected event of pyrexia. The event dehydration, amnesia and pyrexia occurred 2 days after mRNA-1273 (Lot# 030L20A), while the event of pain in extremity, dizziness, pain, dysphonia occurred on an unspecified date after mRNA-1273 (Lot# 030L20A). Treatment included Tylenol and IV fluids. 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 events, a causal relationship cannot be excluded. Additional information has been requested.
69 2021-02-08 confusional state Fever, confusion, sepsis, hospitalized
69 2021-02-09 insomnia 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 restlessness, sleep disorder Within 1 minute of receiving vaccine there was a strong metallic taste in my mouth that lasted until... Read more
Within 1 minute of receiving vaccine there was a strong metallic taste in my mouth that lasted until the next morning. There was also a slight dizziness and moderate nausea which dissipated after a meal. Eating did not eliminate the metallic taste. Sleep was disturbed on the night of the 3rd, restless body, and slight headache. The following days I experienced a light headed feeling.
69 2021-02-10 anxiety Elevated B/P, Headache; Anxiety; Refused to go to the hospital
69 2021-02-10 loss of personal independence in daily activities 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 sleep disorder Woke up at 3 am and could not rest on right arm too painful pain radiates and still does 12 hours la... Read more
Woke up at 3 am and could not rest on right arm too painful pain radiates and still does 12 hours later up and down entire right side arm neck to ear . Woke up again at 8! sneezing only right side sneezes lasted 3 hours sneezing constantly finally 2 pump in both nostril zicam nasal spray. But started back up nose dripping ... headache ... no fever ,
69 2021-02-11 feeling abnormal The night of the same day I rec'd the vaccine, my body was very achy. I did not think to take my te... Read more
The night of the same day I rec'd the vaccine, my body was very achy. I did not think to take my temperature, as I was diagnosed with Covid-19 on Dec 17th and I had ONLY common cold symptoms with NO fever. The day after the vaccine 2/10, I woke early feeling TERRIBLE, I had chills for hours. I took my temperature right away at 7am and it was 100.4. My regular temp with the forehead thermometer is 97.7 or 97.8. I had the fever all day and night, I was nausea, I had a very bad headache, body aches and felt completely fatigued. I went to bed at 7:30pm that night and slept all night. I work without a fever the next day 2/11 but still felt tired and slightly nauseous all day. That night I went to bed at very early.
69 2021-02-11 insomnia 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 2021-02-14 loss of personal independence in daily activities About a week after my first vaccine, I noticed a pain in my left shoulder near the injection site th... Read more
About a week after my first vaccine, I noticed a pain in my left shoulder near the injection site that felt similar to a shoulder injury I had 3 years ago when I tore my shoulder ligament resulting in a hairline fracture in my humerus. I thought it was just swollen from the shot in my muscle and would go away in a week or so. 5 weeks later, I am experiencing pain in my shoulder that feels exactly like my injury 3 years ago. Can't lift my arm, can't pull up my pants or put my seatbelt on, have difficulty putting my arm in a sleeve when dressing, have significantly reduced mobility in that arm and it has not gotten any better. Seems worse. Haven't seen a doctor yet. Still hoping it will get better and not sure which doctor to see. Trying to find out if this was caused by the vaccine injection before deciding if I should see my internist or shoulder doc.
69 2021-02-15 nightmare Itchiness at the injection site started on Feb. 15. On the morning of Feb. 16, I woke up with redne... Read more
Itchiness at the injection site started on Feb. 15. On the morning of Feb. 16, I woke up with redness and swelling about the size of three quarters at the injection site. My upper arm was swollen and enlarged in size. I have also been having intense nightmares since February 4.
69 2021-02-15 sleep disorder Awakened in the middle of the night with fever and chills. Fever subsided by 9am but extreme fati... Read more
Awakened in the middle of the night with fever and chills. Fever subsided by 9am but extreme fatigue persisted another 12 hours accompanied by nausea. No vomiting; however I experienced two very loose stools during the aforementioned 12 hours period. I had L. arm pain and redness at the injection site for 3 days following the vaccine.
69 2021-02-15 sleep disorder After waking with only an hour sleep I could not get back to sleep and as night went on I became ove... Read more
After waking with only an hour sleep I could not get back to sleep and as night went on I became overwhelmed with extreme pain, not just body aches. I fell asleep about 9:15 am on 2-13-2021 for about an hour and woke with fever but could hardly move. I have had body ache from being sick with flu before but never where I could hardly move. I could drink but had no appetite that day. The fever got to 103 at one point . Eventually the fever broke about 4:00 am on 2-14 -2021. The site where the shot was administered was swollen with a rash that spread out about 5 inches long by 3 inches wide. I had no side effects at all from first dose.
69 2021-02-18 feeling abnormal, irritability 1. Pain and soreness in my muscles, bones and joints in all parts of my body. 2. It is difficult t... Read more
1. Pain and soreness in my muscles, bones and joints in all parts of my body. 2. It is difficult to move without pain and discomfort. 3. "Brain Fog" I am unable to remember names, exact dates. 4. Repeating the same information. 5. Irritability, moodiness - mood disorders.
69 2021-02-18 feeling abnormal PATIENT REPORTED WAKING UP ON 2/5/21 FEELING "BAD" RIGHT EAR WAS SWOLLEN, RED AND HAD HEAT. ALSO FEL... Read more
PATIENT REPORTED WAKING UP ON 2/5/21 FEELING "BAD" RIGHT EAR WAS SWOLLEN, RED AND HAD HEAT. ALSO FELT VERY ACHEY. 2/6/21 PATIENT REPORTED TO DOCTOR LISTED AS POSSIBLE ALLERGIC REACTION TO VACCINE-PT RIGHT EXTERAL EAR HAS GROSS ERYTHEMA AND INFLAMMATION AND CANNOT DISCOUNT REACTION FROM COVID -19 VACCINE GIVEN 48 HOURS AGO. PT WAS ADMINISTERED 80MG OF METHYPREDNISOLONE BY INJECTION AND DEXAMETHOSONE 10MG BY INJECTION. PT WAS GIVEN RXS FOR AUGMENTIN 875MG 1 PO Q12H X10DAYS, AND PREDNISONE 10MG 1 PO QD X5DAYS. MD ALSO RECOMMENDED TAKING BENADRY 1TSP Q12H X5 DAYS . PT REPORTED EVEN TO PHARMACY-WE HAVE NOT BEEN ABLE TO REACH PATIENT SINCE 2/6/21 TO DETERMINE PROGRESS OR OUTCOME. PT SHOWED NO ALLERGIC REACTION AT TIME OF INJECTION OR DURING 15 MINUTE WAITING PERIOD. DID NOT INDICATE THAT THERE WAS ANY REACTION WITH 4 HOURS OF RECIEVING VACCINE. ASKED PT IF SHE WAS TESTED FOR COVID WHEN SHE WENT TO BE SEEN FOR REACTION AND SHE SAID SHE WAS NOT.
69 2021-02-19 anxiety 10 pm Feb 18th, the evening of the vaccine I started having body aches, uneasiness, tiredness and p... Read more
10 pm Feb 18th, the evening of the vaccine I started having body aches, uneasiness, tiredness and possibly a slight fever which lasted thru fri, Feb 19.
69 2021-02-20 abnormal dreams Shot went in great. That night of the shot I started having pain in the arm around 9:00, around 10:... Read more
Shot went in great. That night of the shot I started having pain in the arm around 9:00, around 10:30 I felt chills, flu like, took advil. Next morning I stayed in bed all day, I had 99.9 temp, mine is usually 97.7, Diarrhea, also, crazy dream, stayed in bed all day, took advil,. Thursday, got up, went back to bed, dizzy, head ache, no temp. Friday, got up head ache, took advil, Saturday, got up had head ache, dizzy, went to bed, got back up got the chills, went into take show, noticed a rash on my arm, at sight where shot given, tender to the touch. Went in to Urgent care, told redness was high sensitivity, not celulitus, but to watch. Today Sunday, I feel great.
69 2021-02-20 confusional state 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 2021-02-20 disorientation Symptoms began approximately 11 hours after 2nd dose of Moderna Covid vaccine. Fever that maxed out... Read more
Symptoms began approximately 11 hours after 2nd dose of Moderna Covid vaccine. Fever that maxed out at 101 degrees 2-hrs later, headache, stiff & sore neck, mild shivering & chills, hand tremors, eyes hurt, stuffy sinuses, balance problems & stumbling, spacey feeling (disorientation), painful cramping in thumb & fingers of one hand (only occurred once), extremely fatigued & lethargic, no appetite. All symptoms resolved within 16-18 hours after onset. No treatment. Resolved spontaneously.
69 2021-02-20 insomnia Chills, headache, muscle soreness, insomnia and fatigue. Treatment - Tylenol -Moderna COVID Vaccine... Read more
Chills, headache, muscle soreness, insomnia and fatigue. Treatment - Tylenol -Moderna COVID Vaccine EUA
69 2021-02-21 feeling abnormal Blood surges not controlled, slept ca 24/7, tired, felt out of place r kilter
69 2021-02-21 sensation of foreign body PATIENT LEFT FACILITY AFTER OBSERVATION PERIOD WAS COMPLETE. PATIENT RETURNED TO FACILITY AND REPOR... Read more
PATIENT LEFT FACILITY AFTER OBSERVATION PERIOD WAS COMPLETE. PATIENT RETURNED TO FACILITY AND REPORTED "LIKE A WALNUT" IN THE THROAT. EPI ADMINISTERED IN LEFT THIGH. 911 CALLED. EMTS ARRIVED STARTED IV BENEDRYL AND ZOFRAN. PATIENT TRANSPORTED TO HOSPITAL FOR FURTHER EVALUATION.
69 2021-02-23 feeling abnormal Temperature of 101 headache, extreme fatigue, body aches, brain fog, shortness of breath, loss of t... Read more
Temperature of 101 headache, extreme fatigue, body aches, brain fog, shortness of breath, loss of taste and smell for 4 days
69 2021-02-23 insomnia The injection was painless and I was very happy to finally be able to receive this vaccine. Evening... Read more
The injection was painless and I was very happy to finally be able to receive this vaccine. Evening on the first day began to feel slightly feverish 99.2, body aches, fatigue, slight ache in my arm at injection site. This continued into the next day and nights. No problems at all in days 3 through 6. In the evening of the 7th days began with fatigue, body aches, fever 99.4, chills. Did not sleep well that night due to body aches and chills and woke the next morning - day 8 with very red, sore arm just below the injection site that started out in a circle and expanded to about 2" x 3" area.
69 2021-02-23 mental status changes Patient presented to ER on 2/16/2021 after getting covid vaccine 4 days prior. According to patient'... Read more
Patient presented to ER on 2/16/2021 after getting covid vaccine 4 days prior. According to patient's family, she was moving slowly, not eating, experiencing some weakness and fatigue ever since. Patient was determined to have UTI and given 7 day course of cephalexin 500 mg three times daily. Followed-up with Health & Wellness on 2/17/2021. Patient went to ER again on 2/21/21 due to continued issues including altered mental status.
69 2021-02-24 confusional state Daughter states less than 24 hours after receiving vaccine pt had fever and chills. Was shaking/ jer... Read more
Daughter states less than 24 hours after receiving vaccine pt had fever and chills. Was shaking/ jerking and confused. Went to ED. Was told bloodwork was good and was sent home.
69 2021-02-24 insomnia severe headache, chills, body aches, fatigue, insomnia
69 2021-02-25 anxiety Pt alert and coherent. Anxiety reaction, resulted in asthma attack, slight wheezing Described that ... Read more
Pt alert and coherent. Anxiety reaction, resulted in asthma attack, slight wheezing Described that she felt like she got anxious and started having an asthma attack. Patient treatment: 2:35pm BP: 140/92, Pulse OX 100%, 92 pulse, treatment given Albuterol HFA 90mg, pt. own Famotidine 10 mg, lowered BP pulse improved 2:40 pm BP: 136/86, 72 pulse -Treatment given: Benadryl 25 mg - as prophylaxes, pt. monitored for 1 hr. after no symptoms, then went home with instructions to call 911 if anything else occurred 5:00 pm follow up, patient at home, no symptoms Pt primary prescriber contacted with hour of monitoring, and agree patient could be released home.
69 2021-02-25 anxiety 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 2021-02-25 feeling abnormal, thinking abnormal 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 feeling abnormal First dose: red, itchy rash on lateral aspect of lateral left arm beginning 10 days post vaccination... Read more
First dose: red, itchy rash on lateral aspect of lateral left arm beginning 10 days post vaccination, lasting 3 days; mild headache and stomach upset Second dose: pain at injection sit beginning 4 hours post vaccination intensifying to reduction of mobility for 24 hours and abating over the next 24 hours; intense shaking, chills, bone/joint pain, muscle aches and impairment, nausea, headache also intense for first 24 hours and abated over next 24 hours; at 48 hours I awakened with sweats and feeling better. I am still not fully recovered and experiencing shaking, brain fog.
69 2021-02-25 feeling abnormal Pt states she couldn't breathe and was completely out of whack. Was taken to health center and then ... Read more
Pt states she couldn't breathe and was completely out of whack. Was taken to health center and then transferred to hospital in Wichita, KS. States they diagnosed her with pneumonia.
69 2021-02-25 excessive sleepiness Fever (101), headache, lethargic, slept pretty much all day & night, no appetite.
69 2021-02-25 sleep disorder 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 2021-02-26 confusional state This morning upon awaking was unable to rise from bed, semi-paralysis, peed in the bes as was unable... Read more
This morning upon awaking was unable to rise from bed, semi-paralysis, peed in the bes as was unable to move any extremities to allow me to get up! Fever, chills, badly shaking, unable to walk unaided. some confused thinking. Unable to call out for help or recall how long I had remained motionless.
69 2021-02-26 sleep disorder 02//25/2021 (day of vaccination-starting 2 hours after injection) had intense pain, discomfort in le... Read more
02//25/2021 (day of vaccination-starting 2 hours after injection) had intense pain, discomfort in left arm vaccinated and was unable to move arm without pain, which also did not allow me to sleep that night (no pain relievers taken) and chills. Next day, 02/26/2021, arm pain still intense along with loose stool, nausea for about 1/2 hour, as well as entire day of fatigue, fever about 3 degrees above normal, no appetite, lethargy, chills. 2/27/2021 had diarrhea, lethargy, and no appetite as well as lessening of sore arm, no appetite, and no fever.
69 2021-02-27 feeling abnormal 24 hours after shot, headache, mild left arm soreness. Over next several days, very mild transient d... Read more
24 hours after shot, headache, mild left arm soreness. Over next several days, very mild transient dizzy spells, mild headache, feeling ?off?...brain fog....approximately 9:30 am 2/26/21, walked into a store and after getting 1/2 way to back of store, had sudden onset distorted vision...not dizziness, distorted vision...had to ask for a chair as I felt like I was going to pass out...distorted vision lasted approx 6-8 minutes, along with slight nausea. Pulse was 68 and regular. Went to Dr, EKG normal, blood sugar, orthostatics Normal, Pulse ox 98%,. Went home to lie down. Still having occasional fleeting ?dizzy? spells and fatigue.
69 2021-02-28 anxiety, feeling abnormal The second Moderna intramuscular injection felt different from the first injection. This one hurt ... Read more
The second Moderna intramuscular injection felt different from the first injection. This one hurt when injected. About 3:15p.m. that same day, I noticed the arm started hurting. It later became very painful and I had lost strength in the arm and I could not lift my arm. This was alarming to me and I thought there may have been nerve damage. The fatigue, fever and headache came the next day and the arm was painful and unusable. At 2:30pm on Saturday, Feb. 27th, I took 3 Aleve to relieve the pain in my arm. I had hoped to not take anything after getting the vaccine, but I could not stand the pain any longer. I researched online and read about SIRVA. I thought that was responsible for the pain. The Aleve helped. By Sunday, Feb. 28, 2021, the pain had abated and I could use my arm. My fever, fatigue and headache had gone too. My intention in submitting this is to request that more explicit reactions be listed so that someone like me, living alone, would know that this is a possible reaction and to let it run its course. This caused me undue stress, on top of feeling lousy and being in a great deal of pain, not the mention my fear of never being able to use that arm again. That may sound like an overreaction, but until you have had a limb rendered useless, no matter how hard you try to move it, it is frightening. I would appreciate any feedback on my experience and I would like to know if others have experieinced this too. Thank you.
69 2021-02-28 anxiety 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 2021-02-28 feeling abnormal Redness and swelling at the injection site, pain felt during the injection of the needle, elevated t... Read more
Redness and swelling at the injection site, pain felt during the injection of the needle, elevated temperature (99.8) the follwing day, headache the following two mornings and foggy brain symptom on the third morning. Treatment at home including ice of the injection site that evening and the following day, and ibuprofen (200mg) as fever reducer.
69 2021-02-28 feeling abnormal Day after injection I got out of bed and was UNABLE to walk, nor could I crawl on my knees. I belly... Read more
Day after injection I got out of bed and was UNABLE to walk, nor could I crawl on my knees. I belly crawled to the bathroom but was unable to get up on the toilet. The symptoms improved over the course of the day but was not able to walk normally until the following day. I experienced vomiting, headaches (still persist) brain fog (continues) and fatigue.
69 2021-03-01 feeling abnormal Her arm got immediately sore, then about 7:00 PM she got chills, achy, did not feel good, covering u... Read more
Her arm got immediately sore, then about 7:00 PM she got chills, achy, did not feel good, covering up. Then she took her temp around 11:00 PM and hers was 100. Almost the feeling of having the COVID virus all over. Had night sweats, still doing that. Joint aching, muscle aching, just wiped out with no energy. Overall weakness, like a dishrag. Took Tylenol for the fever. Still having the night sweats last night but otherwise basically back to normal.
69 2021-03-01 impaired work ability, loss of personal independence in daily activities Normal symptoms first night, fatigue, aching, headache but then early morning on 27th injection site... Read more
Normal symptoms first night, fatigue, aching, headache but then early morning on 27th injection site extremely painful causing extreme joint pain in my shoulder in the front and top of shoulder that resulted in not being able to use my left arm without excruciating pain for over 5 days resulting in loss of work and normal activities.
69 2021-03-02 excessive sleepiness Never run fevers -but ran 102.5 for 24 hrs. Then 99.5 second day. Nausea, diarrhea , headache. Red a... Read more
Never run fevers -but ran 102.5 for 24 hrs. Then 99.5 second day. Nausea, diarrhea , headache. Red area at vaccine site.Slept for 16 hrs. Had no reaction to first dose
69 2021-03-03 feeling abnormal I did not feel ok starting Wednesday , symptoms increased daily with Saturday being the worst. Tire... Read more
I did not feel ok starting Wednesday , symptoms increased daily with Saturday being the worst. Tired, feeling warm Friday and Saturday, exhaustion increasing Wednesday until Saturday, the worst day being Saturday, and headaches. I felt more flu like symptoms on Wednesday and Thursday and not so noticable on Friday and Saturday. About 8/9 pm on Saturday I felt fine, like you snapped your fingers and all the side effects were gone.
69 2021-03-04 feeling abnormal At 12 hours after injection: high fever, chills so bad teeth chattering, aches muscles in in neck, b... Read more
At 12 hours after injection: high fever, chills so bad teeth chattering, aches muscles in in neck, back, ankle (areas that have problems or injured in past, Hourly urination with intense pain and muscle spasm of muscle holding the urination - these stopped at about 5:00 am; Then a fever of 99 and cold clammy feeling for a day - was not able to stand for more than a few minutes without feeling off balance and then just exhausted. For a week I was mentally cloudy and my vision was at times a little blurry. Now...2 weeks later I have developed a UTI and Bacterial Vaginosis. I feel fine otherwise.
69 2021-03-04 memory impairment, anxiety unable to stay standing without falling; getting anxiety ridden; tried to get out of bed and fell; c... Read more
unable to stay standing without falling; getting anxiety ridden; tried to get out of bed and fell; couldn't talk; memory started to go; tremor in right, dominant hand; feeling sick; A spontaneous report was received from a consumer regarding a 69-year-old, female patient who received the Moderna COVID-19 Vaccine (mRNA-1273) and experienced tremors in right, dominant hand/tremor, trouble standing but was not falling down/balance disorder, feeling sick/malaise, tried to get out of bed and fell/fall, memory started to go/memory impairment, couldn't talk/aphasia, and getting anxiety ridden/anxiety. The patient's medical history included Lyme Disease, severe back problems, high cholesterol, acid reflux, sleep disturbances and nerve pain. Concomitant products known to have been used by the patient, within two weeks prior to the event, included Hydroxychloroquine, Clarithromycin, Amoxicillin, Doxycycline, Lipitor 80 mg, Oxycodone 45 mg four times daily, Trazodone, Ambien, Pepcid, Lyrica, Pantoprazole 40 mg, Cyclobenzaprine, Valium 5 mg, Klonopin 0.5 mg. On 12FEB2021, the patient received the second of two planned doses of mRNA-1273 (BATCH: 013L2DA) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 23FEB2021, the patient reported the following events after receiving the first dose of Moderna COVID-19 (mRNA 1273) Vaccine: "The patient reported that on 15Jan2021, she received her first dose of the Moderna COVID-19 Vaccine in her left non-dominant arm, at her local Department of Health. Within days after receiving her first dose, she experienced tremor in her right, dominant hand. The patient reported that her hand was shaking, and she was dropping things, spilling and had trouble standing but was not falling down. The patient reported that prior to receiving her first dose of the Moderna COVID-19 Vaccine, she had been taking Hydroxychloroquine and Clarithromycin to treat Lyme Disease. She had been on these two medications for a couple of weeks. The patient thought that the tremors might have been due to the Hydroxychloroquine and because she was also feeling sick, she stopped taking the Hydroxychloroquine, but continued taking the Clarithromycin. The tremors continued. Her doctor advised her to resume taking the Hydroxychloroquine, starting with ¼ pill, then ½ pill working her way up in dosing. The patient reported that her hand tremors never stopped". On 23FEB2021, the patient reported the following events after receiving the second dose of Moderna COVID-19 (mRNA 1273) Vaccine: "On Friday, 12Feb2021, the patient received her second dose of the Moderna COVID-19 Vaccine in her dominant arm, at the same facility. By Monday, 15Feb2021 and Tuesday,16Feb2021, after receiving the second dose, the patient's tremors increased. She reported that she "got much worsening shaking in hand". She was "unable to stay standing without falling". She also stated that her "memory started to go" and she started dropping things such as glasses of juice, spilling things and her memory was getting worse. On Thursday, 18Feb2021, the patient reported it started getting so bad, "tried to get out of bed and fell". She stated that she tried to hold on to something but her body would twist and she wound up on the floor. On Friday, 19Feb2021 her husband called Emergency Medical Services (EMS) and had her taken to the hospital. She stated that she couldn't remember what day it was, who was the President, her date of birth or a lot of things. She stated that she was going blank and could not stand up without assistance. She said that she couldn't talk and it was very scary. She was admitted to the hospital on the following day, Saturday, 20Feb2021. She states that she was "getting anxiety ridden" and her "whole body just shakes". The patient stated that they ran a battery of tests and she was discharged the next day, on Sunday, 21Feb2021, because as she stated "they couldn't find anything". The patient informed the hospital that she had had the 2nd Moderna COVID-19 Vaccine. She was told that her symptoms had nothing to do with the vaccine, but she disagrees". The action taken for Moderna COVID-19 Vaccine was reported hospitalization. The outcome of the events was reported as recovering.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
69 2021-03-05 insomnia Insomnia - my husband also got the vaccine and we were unable to sleep the entire night.
69 2021-03-05 sleep disorder Approximately an hour after I received the shot, I felt pins and needles on my lips and a metallic t... Read more
Approximately an hour after I received the shot, I felt pins and needles on my lips and a metallic type taste in my mouth. My arm was sore , as expected, and I felt some body aches, and tiredness. It wasn't until Tuesday that my mouth was feeling numb and the bad taste in my mouth returned. I did not have an appetite to eat. It didn't seem to bother me as much during the day as nighttime. I would wake up in the middle of the night with a terrible taste in my mouth and nausea. It seemed to be most uncomfortable by Thursday evening and I drank a lot of water all day Friday. I did not eat much on Friday because of the nausea and taste in my mouth. After I did eat something early Friday evening, I became very tired. Today I am better. I do not feel like my mouth is numb, and the bad taste is not completely gone, but I feel better. I will drink a lot of water today.
69 2021-03-07 disorientation, confusional state, delirium The patient had the vaccination given at 10: 30 AM on 2/28/2021 and became lethargic and deliriums a... Read more
The patient had the vaccination given at 10: 30 AM on 2/28/2021 and became lethargic and deliriums at 9 pm. She was alert and oriented to person, place and time at baseline, she became confused, not able to find her words, oriented only to person for 3 days. She presented to Hospital on Tuesday 3/2/2021 and improved with conservative measures on Friday 3/5/2021.
69 2021-03-07 feeling abnormal, anxiety Apprehension, slight nausea, brain fog
69 2021-03-07 excessive sleepiness She had the vaccine, and about 4 hours later started getting chills. The next day had a temperature... Read more
She had the vaccine, and about 4 hours later started getting chills. The next day had a temperature of 102.4, took some Tylenol. She slept a lot and drank a lot of water. She continued to have the chills, generally just felt really bad. The chills lasted off and on until Saturday 2/6/21. On Sunday, 3/7/21 she still did not feel well, and finally about 6:00 PM last night she felt fine, all the symptoms all of sudden subsided.
69 2021-03-07 excessive sleepiness Started feeling sick about 1-2:00 am. Headache, Nausea, Vomiting, loss of appetite, chills, muscle ... Read more
Started feeling sick about 1-2:00 am. Headache, Nausea, Vomiting, loss of appetite, chills, muscle pain, flu like symptoms, runny nose. Slept most of the day, I took tylenol, sudafed, theraflu, tylenol sinus. Sick for a full day (vaccine on Friday and sick all day Saturday) 3rd day, Sundady, dull headache and loss of appetite. 4th day, Monday, slight headache
69 2021-03-07 excessive sleepiness The day following the 2nd vaccine her arm had some swelling, soreness that radiated down the wing of... Read more
The day following the 2nd vaccine her arm had some swelling, soreness that radiated down the wing of her back. She was achy, doesn't believe she had fever, but had chills and just slept a lot, just didn't feel good. This reaction lasted 24 hours and then all went away. She took Ibuprofen for the symptoms.
69 2021-03-07 mental status changes, confusional state, feeling abnormal, impaired work ability pt states that she developed a bad headache next day after getting the vax. Pt was very confused, v... Read more
pt states that she developed a bad headache next day after getting the vax. Pt was very confused, vomiting, and had brain fog so she called her son. She was getting worse and having spots, stars and flashes in front her eyes so he took her the OSF ER on 2/5/2021.They did a CT and blood work. Pt was admitted and assessed by a Neurologist and Physical Therapist. She was told she had altered mental status. She was stayed for 3 days and discharged. She stayed with her son for 6 days and then went to her PCP which told her not to return to work at this time. Pt will FU on 3/24/2021.
69 2021-03-07 nightmare Muscle ache, fever, headache, chills, nausea. loss of taste and smell, nightmares nightly.
69 2021-03-07 sleep disorder tingling in ears and chin after injection. By 11:00 pm, 12 hours after the vaccination, I began deve... Read more
tingling in ears and chin after injection. By 11:00 pm, 12 hours after the vaccination, I began developing a painful headache and severe body aches and joint pain from head to toe. It actually hurt to lay down. I was unable to sleep, even after taking Tylenol. I spent the day dozing on the couch and by late evening, about 10:00 pm. I began to feel slightly better. The pain in my shoulders and the area on my upper back beneath my neck felt like one giant connected muscle with awful pain that was a combination of pressure and tightness. I slept well that night and woke yesterday (Sunday) without the severe pain. No headache and only slight discomfort. Today (Monday) I feel mostly okay but there is still some residual discomfort even after a 3 mile walk this morning.
69 2021-03-08 anxiety Patient described feeling lightheaded immediately after getting the vaccination, but walking in outs... Read more
Patient described feeling lightheaded immediately after getting the vaccination, but walking in outside in the cold weather improved sx. She was able to drive home safely and didn't experience any other sx until 8pm that evening. She reports that the lightheadedness, anxiety, feeling hungry and "out of sorts." The patient reports no sx over the next two days, but woke up today with a milder version of previous sx.
69 2021-03-08 disorientation 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 sleep disorder severe muscle ache in both arms and body aches, no energy and trouble sleeping.
69 2021-03-09 excessive sleepiness Fever started about 5:00pm and lasted 24 hours. Started feeling drowsy about 4 hours after the vacc... Read more
Fever started about 5:00pm and lasted 24 hours. Started feeling drowsy about 4 hours after the vaccine. I slept for about 2 days and couldn't stay awake. Headache started that evening. I still have the headache 3 weeks later with no relief. My right cheek and gums hurt so bad too.
69 2021-03-09 nervousness, feeling abnormal High fever (101.4 - 102), from evening of injection and continuing through Monday, March 8. Current... Read more
High fever (101.4 - 102), from evening of injection and continuing through Monday, March 8. Currently continuing fever of 99+ unless ibuprofen is taken (March 10, 6:15 p.m.) - fever returns after several hours. Exhaustion, foggy thinking, nervousness.
69 2021-03-09 sleep disorder Patient states that her legs and hips are extremely sore. She states that when standing, her legs fe... Read more
Patient states that her legs and hips are extremely sore. She states that when standing, her legs feel like they are going to give out. Her joints in her hips hurt a lot. She states that it woke her up from a sound sleep. It hurts the most when lying down. She states that when on her feet it is a little better. It has been very bad every night, but each day it is a little better
69 2021-03-09 sleep disorder Have large rash on arm and pain is still continuing at injection site (large red dot on arm) 8 days ... Read more
Have large rash on arm and pain is still continuing at injection site (large red dot on arm) 8 days later. Difficulty sleeping on my left side due to pain. Will seek medical attention if it does not resolve in the next few days.
69 2021-03-10 abnormal dreams 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 anxiety 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 excessive sleepiness the day after the vaccine I slept all day. Next day felt 100% better. On the 3rd day I began feeli... Read more
the day after the vaccine I slept all day. Next day felt 100% better. On the 3rd day I began feeling exhaustion and weakness as though I had been very sick and my body was having difficulty recovering. 20 years ago I had an autoimmune issue (Chronic Fatigue Syndrome) and asthma that took me about 10 years to get under control. I started getting shortness of breathe and I was concerned I may have gotten COVID, but I since took a test and do not and have never tested positive (about 5 tests). I had 2 days of Renaud's incidence when one segment of my right forefinger completely drained of blood, and turned white. (Same finger both days). It took me 10 minutes of massage and windmills with my arm to bring color back to the finger. The shortness of breathe continues weeks later and it appears my asthma has returned. Went to the doctor last week and we are starting with and inhaler to see if that takes care of it. I have had to use it every day since I got prescription 3/6 - all day the first day, lesser since. Still shortness of breathe and feeling compromised. My sister has worse autoimmune problems and MSRA. After her Moderna vaccine last week she was confined to bed the whole week with her 1st vaccination. She had not been exposed to COVID that she is aware of. Neither of us ever smoked. Could be our lungs were already compromised with both parents heavy smokers and growing up where all the smog from the 1960's would linger. Our breathing would ache from exertion. A brother, once a heavy smoker, has had emphysema, and serious heart damage from a heart attack, and suffers from a lack of O2. He has not had a shot yet and we are concerned about his response.
69 2021-03-10 nervousness, feeling abnormal 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 2021-03-11 feeling abnormal Sore arm 3 days, Nauseous, vertigo, brain fog, Aches- all for 3 days. Later a hacking cough
69 2021-03-11 feeling abnormal 2/28 I had a burning itching feeling in my arm at the injection site. the next day I had a 2 inch di... Read more
2/28 I had a burning itching feeling in my arm at the injection site. the next day I had a 2 inch diameter swollen area that was red and warm to the touch. the next day the color decreased but I was queasy and tired. the next day I was ok. the next day I was queasy and tired again and felt awful. that lasted 2 days. the next day I had diarrhea and headache and queasy tired and funky feeling for another 2 days. the arm stayed pink/red and sore for 5days. I iced it. head still feels like its heavy and buzzy feeling.
69 2021-03-11 insomnia Insomnia night of injection; sore arm and body aches.
69 2021-03-11 insomnia The day after the shot I was tired, groggy and achy. I took two naps and some ibuprofen. In the days... Read more
The day after the shot I was tired, groggy and achy. I took two naps and some ibuprofen. In the days following, I experienced severe aches and pains in my upper arms and thighs. This continued and got steadily worse for two weeks. No fever or loss of taste. I called the doctor and was told people have different reactions, maybe I should get tested for covid. I did not. Pain continued. I had trouble sleeping, despite constant ibuprofen. I could not turn over in bed. End of the third week I went to an accupuncturist/massage therapist, who has helped me before . I 've had two treatments and am feeling incrementally better each day. Thinking back on how I feel today--which is still achy, as you might feel with the flu--I realize I was in serious agony for those weeks before treatment. Just prior to the shot, I had been for a full physical and bloodwork and was judged by my doctor to be one of the healthiest people in her practice. I was perfectly fine before this shot.
69 2021-03-11 loss of personal independence in daily activities Chills within 90 minutes of vaccine; 4 hours later, severe muscle & body aches, chills; no elevated ... Read more
Chills within 90 minutes of vaccine; 4 hours later, severe muscle & body aches, chills; no elevated temp; headache; nausea; no appetite; significant pain/discomfort at vaccination site. Symptoms were severe, lasted 72 hours during which I was bedridden. Arm (vaccine site) lasted 5 days. Self treatment : ibuprofen; Tylenol; fluids; lots of sleep; anti-nausea prescription which I had on hand.
69 2021-03-12 excessive sleepiness By 7 pm, Thursday sweating began. I was in bed before 9 pm. due to extreme tiredness, and awoke abou... Read more
By 7 pm, Thursday sweating began. I was in bed before 9 pm. due to extreme tiredness, and awoke about 40 minutes later with severe leg cramps accompanied by burning sensations throughout leg veins. This lasted about 15 minutes, compared with 90 minutes the month before after vaccination #1. The ensuing 36 hours, through which I mostly slept, had bouts of nausea, fatigue, fever and chills. All these were listed as possible side effects, except leg issues.
69 2021-03-12 impaired work ability, disturbance in attention Within two (2) hours after receiving Moderna dose #2, there was significant soreness at the injectio... Read more
Within two (2) hours after receiving Moderna dose #2, there was significant soreness at the injection site, but no redness. Patient experienced headache, fatigue, severe muscle aches, fever, chills, body pains, inability to focus and/or do any work. Patient kept hydrated, bundled in very warm clothing and bed clothes, took two (2) Advil capsules and went to bed. Patient continued process for the entire day, and then took two (2) more Advil capsules at midnight, and went back to bed and sleep. Patient awoke at 7 a.m. on March 13th, 2021, with continued left arm soreness, but without other complaints.
69 2021-03-12 sleep disorder Fever (100.4), severe joint and muscle pain, severe headache, tremors, teeth ache, inability to sle... Read more
Fever (100.4), severe joint and muscle pain, severe headache, tremors, teeth ache, inability to sleep, fatigue Symptoms stated at 7p with aches and tremors, fever started at 10p, fever broke at 3:30a
69 2021-03-14 insomnia Had the vaccine at 11:40 am, started headache around 9 pm that night. Went to bed, had fever, chills... Read more
Had the vaccine at 11:40 am, started headache around 9 pm that night. Went to bed, had fever, chills, shaking all over, terrible joint and muscle aches and pains, headache, nausea, couldn't sleep. Injection site was and still is very swollen, red, itchy. Still sick the next day, Friday, March 12th and Saturday March 13th. Had bouts of diarrhea on Saturday evening. Cramping, nausea. Slightly better Sunday March 14th, but still extremely tired and achey. Today, Monday, March 15th I am able to sit up and function finally. Not as much nausea, no cramping, only slightly achey. I had Covid July 2020 and this reaction, etc was worse than the covid experience!! Not sure I want to get my second vaccine.
69 2021-03-15 feeling abnormal Extreme fatigue for two days Saturday and Sunday; very "fuzzy" headed and unable to concentrate on a... Read more
Extreme fatigue for two days Saturday and Sunday; very "fuzzy" headed and unable to concentrate on anything important. Chills - I was hot, then cold. Seemed to be over by Monday morning.
69 2021-03-15 impaired work ability Chills, Nausea, Fever, Aches, Diarrhea, Headache - unable to work for 2 days - symptoms milder but s... Read more
Chills, Nausea, Fever, Aches, Diarrhea, Headache - unable to work for 2 days - symptoms milder but still linger 5 days later
69 2021-03-15 impaired work ability After approx 3 hours, chills, overnight began severe muscle aches and joint pains, often stabbing pa... Read more
After approx 3 hours, chills, overnight began severe muscle aches and joint pains, often stabbing pain, low grade fever. To descibe as flu-like symptoms is way to mild, this was awful for about 60 hours, then stopped. I could not work for 2 days and was in bed.
69 2021-03-15 sleep disorder Shortly after my second dose of Moderna, I started experiencing pain in my upper left thigh, while s... Read more
Shortly after my second dose of Moderna, I started experiencing pain in my upper left thigh, while sleeping and upon waking. This pain caused me to have to alter my sleep habit of laying on my left side. As soon as I stepped on my leg, I felt a shooting pain. This leg/thigh continues today. I've been able to relieve this pressure with over the counter pain pills and a heating pad. I've started using a walking cane, in the mornings. The first appointment I was able to secure is June 8, 2021.
69 2021-03-15 suicidal thoughts, excessive sleepiness Wanted to die; Extreme exhaustion; Slept for 22 hours straight; Fever; Chills; Headache; Tingling in... Read more
Wanted to die; Extreme exhaustion; Slept for 22 hours straight; Fever; Chills; Headache; Tingling in hand, fingers and arm; Numbness in hands and wrist; 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 extreme exhaustion, slept for 22 hours straight, fever, chills, headache, wanted to die, numbness in hands and wrist, tingling in arm fingers and hand. The patient's medical history was not provided. Concomitant medications as provided by the reporter included vitamins, turmeric and metformin. On 11 Feb 2021,prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032L20A) in the left arm for prophylaxis of COVID-19 infection. On 11 Feb 2021, at 9:00 pm ,the patient experienced extreme exhaustion, slept for 22 hours straight, no appetite but was able to have some cereal, and slept for another 13 hours. She also experienced fever, chills, headache, wanted to die, numbness in hands and wrist, tingling in arm fingers and hand. Treatment medication included low dose aspirin. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of events fever and chills were considered as resolved. The outcome of events, numbness in hands and wrist, tingling in arm fingers and hand ,were not resolved. The events extreme exhaustion, slept for 22 hours straight, headache, wanted to die, 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 events, a causal relationship cannot be excluded. Further information has been requested.
69 2021-03-16 feeling abnormal The first 3 days I had initial nausea, then headache and fatigue. The fourth day I felt better, the... Read more
The first 3 days I had initial nausea, then headache and fatigue. The fourth day I felt better, then from March 8-March 12 I had nausea, a strange fuzzy feeling in my head, dizzy and lightheaded and fatigue. I am able to work part-days but as of March 17, I am still having mild symptoms of slight nausea and feeling off.
69 2021-03-16 excessive sleepiness Severe headaches, fever, dizziness, joint aches,sleepy all the time, confusion, generally weak feeli... Read more
Severe headaches, fever, dizziness, joint aches,sleepy all the time, confusion, generally weak feeling, coughing. All continuous for 5 days after injection.
69 2021-03-18 feeling abnormal Headache for four days, loss of balance , foggy brain feeling
69 2021-03-18 feeling abnormal 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 mental impairment Unable to think; wobbly legs; Weak legs; Unable to eat; Dizzy; Shortness of breath/ Difficulty breat... Read more
Unable to think; wobbly legs; Weak legs; Unable to eat; Dizzy; Shortness of breath/ Difficulty breathing; Fever of 101 degrees Fahrenheit; Chills; Nauseated; A spontaneous report was received from a Health Care Professional concerning 69 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Mental impairment, which is medically significant and experienced Dyspnoea, Chills, Pyrexia, Muscular weakness, Mobility decreased, Nausea, Dizziness, Feeding disorder and Product dose omission issue of routine medicines. The patient's medical history was provided as Covid-19 infection on OCT 2020 and current illness was provided as back problem and 11 mm gallstone. Historical medication was reported as REMDESIVIR for Covid-19 infection. Relevant concomitant medications were reported as Lisinopril-HCTZ daily, Mobic 15 mg daily, Tylenol 1000 mg as needed up to 3 times daily, Multivitamin, Vitamin C, Vitamin D, Vitamin B12, Calcium and Zinc. On 05 MAR 2021, prior to the onset of the event, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: 024A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06 MAR 2021, the patient woke and felt like she was dying, described as having difficulty breathing and almost hyperventilating. She called her daughter-in-law who was a hospital nurse who advised her to breath slowly. The patient had shortness of breath, chills, and a temperature of 101 degrees Fahrenheit. Her legs were so weak that she had to use a walker to get from her bed to the couch, where she stayed until 2:30 am Sunday morning 7Mar2021. While she was on her couch she used a heating pad and was not able to sit up because she was nauseated and dizzy. She was unable to eat anything since Friday night until Sunday afternoon at 1:30 pm. She said she couldn't think on Saturday, and she missed her medicines until she was able to resume taking them Sunday evening 07 Mar 2021. The symptoms were not treated, except for use of the heating pad on Saturday. On 07-mar-2021, Sunday morning at 2:30 am her fever broke. The patient was not as nauseated and did not get dizzy, so she sat up. The patient legs were not as weak and were not wobbling, so she went back to her bed. She began feeling better by 6 or 7 pm on Sunday evening, with no fever, chills, and walking fine. On 08 Mar 2021 she feels fine, excepting she has still had some shortness of breath. The patient had status post Covid-19 infection since October 2020. The patient was hospitalized and received remdesivir therapy for Covid-19 infection prior to receiving the Moderna Covid-19 first dose. She also was already scheduled for two surgeries, one on her back and one for a 11 mm gallstone removal, prior to receiving this first vaccine dose. Her doctor told her she must have the Moderna Covid-19 vaccine prior to beingable to have her surgeries. She describes her symptoms as feeling like she had Covid-19 again. Laboratory details were not provided. Treatment information was provided as heating pad. Action taken with mRNA-1273 in response to the events was unknown. On 07 MAR 2021, the outcome of the event's Mental impairment, Chills, Pyrexia, Muscular weakness, Mobility decreased, Nausea, Dizziness, feeding disorder and Product dose omission issue of routine medicine was considered as resolved. At the of this report, the outcome of the event's Dyspnoea was considered as 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. Further information has been requested.
69 2021-03-19 feeling abnormal, sleep disorder 1st injection: 2/11/21 sore left arm for 24 hrs. 2nd injection: 3/11/21 7:30pm sore arm developed, b... Read more
1st injection: 2/11/21 sore left arm for 24 hrs. 2nd injection: 3/11/21 7:30pm sore arm developed, became exhausted, slight headache & wheezing. 3/12/21 arm hurt, exhausted, headache, wheezing. In bed all day sleeping. 3/13/21 Walked 10,000 steps, tired, headache, wheezing during the day. 3/14/21 walked 10,000 steps. Feeling better. Then 5 pm began feeling achy, tired., bed 9pm. Awoke 10:30pm with nausea stomach pains. 12:30 am vomited. No more sleeping and increased wheezing. 3/15/21 no walk, exhausted and slept in bed all day. Upset stomach. 3/16/21 no walk. felt ok until 10:30am. Became exhausted, increased wheezing and upset stomach. 3/17/21 No walk. Felt slightly better, did nothing but sat in chair. Increased wheezing, started Albuterol inhaler, upset stomach, slight headache. 3/18/21 no walk. Felt terrible , in bed all day sleeping. Headache, wheezing, called doc to renew Albuterol inhaler. 3/19/21 Felt good but still wheezing. 3/20/21 Wheezing but feel pretty good, so far.
69 2021-03-21 excessive sleepiness My arm became very sore about 20 minutes after the vaccination, and continued to become more sore an... Read more
My arm became very sore about 20 minutes after the vaccination, and continued to become more sore and painful. I woke at about 3 am the morning after the vaccination with flu symptoms, very similar to a those in a 3-week illness from last March, 2020. Sinus pain and pressure, low fever, muscle aches, weakness. I was the same later that day, the and continued to have a low fever. By the next day those symptoms were gone, but I felt weak and very fatigued, chilled, and slept much of the day. The symptoms of extreme fatigue, feeling chilled, continued until late on Friday evening, the 19th. I am normally a very active person, but the fatigue was frightening, and not something I normally suffer from. From about 2pm on each day after being vaccinated, my energy plummeted, and the extreme fatigue set in and I slept all afternoon each day and then all night, each day feeling okay in the mornings, then boom, extreme fatigue beginning around 2 pm. I have only experience this kind of fatigue once when I had the flu many years ago, and also last March when my doc thought I had Covid, sent me to the emergency room to be tested, but at that time, they were only testing people who had just returned from China. I want to stress, I am rarely ill, I am very active, and to date am on no medications except vitamins. But last March I was very ill for three weeks then about three more weeks were needed for recovery. My symptoms from this second vaccination have subsided, but with a small amount of fatigue remaining in the afternoons. So, I wonder, from the studies coming out, that I may have indeed had Covid last March, and my immune reaction to the second vaccine was extremely strong. And, possibly I only needed the first vaccination. I filed a Vaers report on my symptoms after the first vaccination, that were also strong, including Covid arm, but subsided about 5 days after that vaccination, a month earlier.
69 2021-03-22 feeling abnormal Debilitating fever, chills, extreme aches, headache, fatigue, nausea lasting 48 hours. Headache last... Read more
Debilitating fever, chills, extreme aches, headache, fatigue, nausea lasting 48 hours. Headache lasted about 5 daysand fatigue and brain fog has been ongoing for over a week. Originally took Tylenol, but it didn't touch the headache so switched to Aspirin, which helped briefly.
69 2021-03-22 loss of personal independence in daily activities, memory impairment Arm hurt as expected. Next day woke to being dizzy when I moved my head the room kept going around.... Read more
Arm hurt as expected. Next day woke to being dizzy when I moved my head the room kept going around. The second day I noticed that I had lost words and names of people, and was having to describe who or what I was talking about. My brain works pretty well so this was disturbing. Also having trouble using the computer - fingers keep being in the wrong place or cannot spell or spelling out the wrong word. Having to look over this pretty well and hope it is understandable.
69 2021-03-23 restlessness INSIDE CHILLS, FOLLOWED BY MUSCLE VIBRATIONS. THEN ESCACATED TO CHLLS FOLLOWED BY EXTREME MUSCLE CO... Read more
INSIDE CHILLS, FOLLOWED BY MUSCLE VIBRATIONS. THEN ESCACATED TO CHLLS FOLLOWED BY EXTREME MUSCLE CONTRACTIONS, THEN ESCLATED TO CHILLS FOLLOWED BY LIMBS, NECK, WRISTS, FINGERS VIOLENTLY JERKING. THE ESCLATION WAS FAST AND I COULD NOT STAND DURING THE WORST OF IT. AFTER IT EASED UP (AFTER ABOUT 3 HOURS) I AM LEFT WITH EXTREME MUSCLE SORNESS ALL OVER MY BODY. I WAS FRIGHTENED DURING THE EPISODE. I HAVENT BEEN TO A DOCTOR IN A FEW YEARS SO DON'T KNOW WHO TO CALL. I THINK I AM FINE NOW. IN RETROSPECT, THE NIGHT AFTER THE SHOT I SLEPT VERY RESTLESSLY AND FELT LIKE I WAS EXPERENCING "VIBRATIONS" THOUGHOUT THE NIGHT. NOW I THINK IT MUST HAVE BEEN MUSCLE CONTRACTIONS.
69 2021-03-24 excessive sleepiness First vaccine on 1/16/2021, I experienced some numbing of my limbs (arms and legs). It was random an... Read more
First vaccine on 1/16/2021, I experienced some numbing of my limbs (arms and legs). It was random and typically didn't last too long (except one time in my left arm that was quite dramatic and I took Bayer aspirin immediately) but was definitely not a normal experience in my body. After the second vaccine on 2/15/2021, the next day, I had the expected fever (100.1 to 100.9) throughout the next 2-days, along with no appetite, energy, or strength. I expected it to dissipate but by day 3 & 4, I felt even weaker and more exhausted. As the days turned into weeks (5+ weeks now), I've experienced severe exhaustion needing to sleep most days 9-13 hours, consistent numbness in my arms (con't next page) and some w/legs, blurry vision, and very unbalanced. I went from walking several miles a day to barely being able to walk a few blocks due to unbalance, weakness and being out of breath. This has gone on for over 5-weeks now. It feels like I am a long-hauler but without having had Covid. I've always been sensitive to drugs, expected to have a reaction, but never imagined something like this would go on for so long. During this period, I had two Covid tests on March 1 and March 10. Both were negative. The week of March 8, I came down with a good old fashioned cold. PCP asked for the second Covid test and chest x-ray (all clear) on March 10. PCP did lab work on March 5. Everything showed as "unremarkable".
69 2021-03-24 nervousness 9 hours after receipt of second dose of moderna shot I started to experience an abrupt onset of sev... Read more
9 hours after receipt of second dose of moderna shot I started to experience an abrupt onset of severe headache, joint and body aches, I felt very hot but could not find a thermometer, but then had extreme chills and had trouble getting warm, dizziness, nausea, vomiting,, lots of fatigue and weakness. These symptoms were relentless for 48 hours and then I was very tired, weak and felt shakey inside, as if my blood sugar was too low( it was checked and was not low) for about 10 days. I am still tired but all other symptoms have resolved. It was a very intense, scary set of symptoms.
69 2021-03-24 sensation of foreign body 3/24/21 3:05 PM 15 min. following injection of Covid -19 vaccine client complained of a scratchy th... Read more
3/24/21 3:05 PM 15 min. following injection of Covid -19 vaccine client complained of a scratchy throat and the feeling of a lump in her throat. First aide provided with observation of vital signs, O2 saturation and one dose of Epi Pen to right thigh. Client's mother and daughter were onsite at the time of the incident. Client remained alert and conversant throughout the event. Vital signs remained stable at 130/72 - 138/60. Pulse 94-83. O2 sat 92% improved to 95% post Epi Pen. 911 called at the onset of symptoms. EMT Team responded and transported client to emergency Department at 3:20 PM. 3/25/21 2:30 PM TC to client. She reports feeling well, returned home by 6:30 PM on 3/24. Stated she was treated with prednisone and Benadryl.
69 2021-03-25 excessive sleepiness, loss of personal independence in daily activities Moderna COVID-19 Vaccine EUA. I had a fever of 99.5 for 2 days and diarrhea for 2 days. Fatigue a... Read more
Moderna COVID-19 Vaccine EUA. I had a fever of 99.5 for 2 days and diarrhea for 2 days. Fatigue and weakness during the whole week after the vaccine. I couldn't eat or drink for 2 days and couldn't go for my usual walk for 4 days, and even then I wore out. No desire yet to do anything but sleep. I was diagnosed with a UTI on 03-24-2021, so am having pain from that now, too. Haven't had one of those since 2019, so there could be some correlation there...I just don't feel well, like I used to.
69 2021-03-26 depression Arm swelled, itched, became red, hot -- scratched so much it made places. This persisted fir about ... Read more
Arm swelled, itched, became red, hot -- scratched so much it made places. This persisted fir about a week.
69 2021-03-26 feeling abnormal Within approximately 12 hours post vaccination, I experienced extreme fatigue, significant body/musc... Read more
Within approximately 12 hours post vaccination, I experienced extreme fatigue, significant body/muscle aching, low grade fever, nausea, significant back pain and general weakness and I described it as feeling like a truck hit me. These symptoms lasted for approximately 72 hours, with slow resolution. I noticed that when I started to feel better, it felt like a fog had been lifted.
69 2021-03-26 loss of personal independence in daily activities First 48 hrs 99 temp, muscular and joint pain debilitating End of second day had to take prednisone... Read more
First 48 hrs 99 temp, muscular and joint pain debilitating End of second day had to take prednisone for right knee, could not walk Knee was swollen intermittenty until 19th Mar 19 th March knee very swollen, could not bend, back on 40g prednisone, Tylenol at night 9 days later cannot bend knee, cannot sit or get dressed knee very painful Walking makes my knee ache, but am massaging and forcing upright movement Doc says continue on pred, unable to begin tapering off I have had gout flareups since before vaccine, this is first time the pred has been unable to make it go down in 3-5 days Slight improvement on 27th can stand with help, walk slowly unaided with out crutches
69 2021-03-26 sleep disorder Paresthesias in left side of back and left leg outside calf area occurred in morning afternoon a... Read more
Paresthesias in left side of back and left leg outside calf area occurred in morning afternoon and night. Did not disturb sleep. Occurred 3/26 multiple times and 3/27 in same areas. Pins and needles sensations I applied ice pack and it reduced the pain
69 2021-03-27 feeling drunk Feeling of passing out rapid heart rate and feeling drunk for 2 days not able to drive
69 2021-03-29 depression depression 3 1/2 days later
69 2021-03-29 loss of personal independence in daily activities Rash on back on right Trouble breathing, could not dress without laying down. Could not make it up... Read more
Rash on back on right Trouble breathing, could not dress without laying down. Could not make it up the stairs. Very active and this is very unusual for me. Hardest part passed in about an hour
69 2021-03-29 loss of personal independence in daily activities Very [paonful hip and knee and joint problems. Could not walk without a walker. Waling is ver painf... Read more
Very [paonful hip and knee and joint problems. Could not walk without a walker. Waling is ver painful and there is always an aching. Leg muscle aches. Right leg only. Cannot move in turning motion. not circular movement. just gives out . Shooting pains in lleg. , Some fatigue but not a problem. Cannot drive, grocerey cart cannot be use. Must use electric cart.
69 2021-03-30 sensation of foreign body 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 2021-03-31 disturbance in attention, anxiety, feeling abnormal, memory impairment Got the shot at 12:30 pm Saturday 3/27. Around 6 hours post-shot, soreness spread from the injection... Read more
Got the shot at 12:30 pm Saturday 3/27. Around 6 hours post-shot, soreness spread from the injection site across my back, into my neck, created a low headache, then went into my right arm and down both arms. Around 7 hours extreme fatigue set in. Chills hit at 9 hours. The headache became more generalized, extreme thirst, aches, shivering, and fatigue went on for exactly 24 hours. No appetite, rolling nausea (no vomiting), mental anxiety, cognitive fuzziness, sleepiness. Unable to read (short term memory and cognition), low attention for television. I never checked for fever. Around 6:30 the next evening (Sunday, 3/28), the symptoms retreated except for the fatigue and headache. Still a bit anorexic, but did eat lightly around 8 pm. Read, watched TV, and slept better. Monday, March 29: I felt very fatigued and fuzzy-brained, but otherwise normal in the morning; the afternoon brought more energy, less headache. Tuesday, March 30: Everything back to normal. Energy and clear thinking returned last.
69 2021-03-31 sleep disorder, disturbance in attention Deep fatigue, feverish w/sweating, body aches, intense, intermittent headache, no attention span, co... Read more
Deep fatigue, feverish w/sweating, body aches, intense, intermittent headache, no attention span, could not sleep. Most severe for 30 hours, followed by less frequent, but similar symptoms. 40 hours later "COVID arm", which I had 10 days after initial vaccination.
69 2021-04-01 disturbance in attention, feeling abnormal 3/30/2021 Injection site soreness for the day of the injection . 3/31/2021 Injection site itching a... Read more
3/30/2021 Injection site soreness for the day of the injection . 3/31/2021 Injection site itching and redness began one day following injection and is ongoing. 3/31/2021 Chills began at roughly 3:30 am on the day following injection and ended by 8:00 am same day. 3/31/2021 Headache, fuzzy-headedness and inability to concentrate, sleepiness, and mild diarrhea began 8:00 am day following injection and were fully resolved by 7:00 am on 4/2/2021
69 2021-04-01 feeling abnormal Apprehension, Feeling faint/fuzzy. States feeling similar to reaction that occurred after IV dye. Re... Read more
Apprehension, Feeling faint/fuzzy. States feeling similar to reaction that occurred after IV dye. Rested - felt better - Released
69 2021-04-01 sleep disorder, restlessness 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 feeling abnormal I received the 2nd Moderna vaccination on 3/25/21. I woke up at 4 am on 3/26/21 with extreme chills... Read more
I received the 2nd Moderna vaccination on 3/25/21. I woke up at 4 am on 3/26/21 with extreme chills & weakness. I couldn't get warm. I finally managed to get out of bed. I turned up the heat, put extra layers of clothes on & lay on the couch with 3 blankets & I still couldn't get warm. Later when I sat up, I used a heating pad too. I spent the day going from couch to bed, battling the chills. At 4 PM that day, I checked my temperature & it was 99.8 F. My normal temperature is around 97. My arm was red & very warm. The area of redness covered my bicep. Tender to touch & sore. The chills went away on the 3rd day, but the redness was there for a week, gradually fading to pink. Today it is gone.
69 2021-04-02 loss of personal independence in daily activities Increasing fatigue and aches, from the second day after. Random pains traveling through body. Had to... Read more
Increasing fatigue and aches, from the second day after. Random pains traveling through body. Had to begin taking Advil by the 4th day after. On the 5th day there was a 4 hour period with severe chills. Had to stay home. Took Advil daily after that ( I never take pain killers). Headaches began on 5th day. And continued throughout the entire 11-day ordeal. GI distress beginning the 3rd day. Not able to eat more than one or two meals a day through out . I forgot to mention I also have a hiatal hernia. Fatigue and other symptoms persisted for entire 11 day period. No respiratory symptoms. Had to have one of my children come and stay for a few days- too tired to cook or go to supermarket.- which is unusual. It felt to me as I had COVID minus the respiratory symptoms.
69 2021-04-04 anxiety Patient received the Covid-19 vaccine. She reports symptoms of Other: anixious, "quezzy", SOB. Pt re... Read more
Patient received the Covid-19 vaccine. She reports symptoms of Other: anixious, "quezzy", SOB. Pt reported that she was anxious prior to arrival. I have observed No acute distress. Treatment/intervention Vitals taken 12:53 169/100 P. 85 Spo2 97% 1:02 160/89 P 87 Spo2 95% 1:06 169/95 P 91 Spo2 95% No distress noted. Vitals signs with no improvement. Pt taken to ED
69 2021-04-04 feeling abnormal, delirium bad, bitter taste in the mouth; brain fog/not feeling themself; fatigue; sweats; delirious; severe v... Read more
bad, bitter taste in the mouth; brain fog/not feeling themself; fatigue; sweats; delirious; severe vomiting for 12 hours non stop; chills; dizziness; nausea; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of delirium in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 dizziness, nausea, fever and headache. On 14-Mar-2021, the patient experienced delirium , sweats, severe vomiting for 12 hours non stop and chills, On 14-Mar-2021, nausea, fever), severe vomiting for 12 hours non stop and headache had resolved. On 18-Mar-2021, the patient experienced bad, bitter taste in the mouth, feeling abnormal, brain fog/not feeling themself and fatigue bad, bitter taste in the mouth, feeling abnormal, brain fog/not feeling themself and fatigue On 19-Mar-2021 bad, bitter taste in the mouth, feeling abnormal, brain fog/not feeling themself, chills and fatigue, outcome were unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient believed they had a cytokine reaction. Patient took Benadryl one hour before the vaccine and the night of the vaccine per physician recommendation. Patient took Tylenol for fever.
69 2021-04-05 insomnia, feeling abnormal RECEIVE SHOT SECOND DOSE 4/3/21..AT AROUND 8 AM..AROUND 1 PM FELT TIRED AROUND 1 PM. RESTED FOR 1... Read more
RECEIVE SHOT SECOND DOSE 4/3/21..AT AROUND 8 AM..AROUND 1 PM FELT TIRED AROUND 1 PM. RESTED FOR 15 MINUTES. WAS OK TILL 8;15 PM WENT RIGHT TO BED..TOOK TWO TYLENOLS AND ZYQUILL...WAS FRIGIDLY COLD, SHAKING...WOKE AT 12 AM...SWEATING PROFUSELY FOR TWO TO THREE HOURS..DRANK WATER THROUGHOUT..BECAME VERY NAUSEOUS. SLEPT HARDLY THAT NIGHT.. SUNDAY MORNING SHOWERED, WANTED TO GO TO EASTER MORNING MASS..WAS VERY TIRED..MASS AT 8;30..BY NINE I ASKED MY HUSBAND SEVERAL QUESTIONS WHEN THEY WOULD DO THIS AND THAT..HE SAID THEY HAD..AFTERWARDS HE TOLD ME HE LOOKED OVER AT ME...AND MY EYES WERE GLAZED OVER... I REMEMBER GOING TO COMMUNION. DID NOT KNOW HOW TO PUT HOST INTO MY MOUTH...DID SO ACKWARDLY. CAME HOME WENT TO BED SLEPT OFF AND ON...SUNDAY NIGHT I TOOK ZYQUILL TO SLEEP...DID NOT SLEEP ALL EVENING NAUSEOUS ALL EVENING..NOW I HAVE NO APPETTITE, DRINK ALOT OF WATER...EAT VERY LITTLE, BUT FOOD I WOULD NOT NORMALLY EAT. RETURN TO WORK ON MONDAY..STILL IN A FOG...I FIND I SAY STUPID THINGS TO PEOPLE I WOULD NOT NORMALLY DO..DAY 3... ALITTLE MORE ENERGY, BUT STILL VERY TIRED..STILL NO APPETITE...STILL NAUSEAOUS .DO NOT LIKE. LOST OF MEMORY...OR THINGS BEING SAID THAT I WOULD NOT SAY..
69 2021-04-06 disorientation Symptoms only after 2nd shot: Severe chillblanes about 14 hours after shot; fever (100 to 102.1) th... Read more
Symptoms only after 2nd shot: Severe chillblanes about 14 hours after shot; fever (100 to 102.1) through 3rd day after shot; total loss of appetite 1st day after shot (drank water, threw up once, could not eat) and only slowly able to eat 2nd to 4th days after 2nd shot; sharp frontal headache for 1 1/2 days, severe fatigue (felt semi-comatose on first day after 2nd shot, exhaustion only slowly lessening over next 3 days ); dizziness and slight disorientation. Acetominophen and ibuprophen did not seem to help much with fever or headache. Drank lots of water throughout.
69 2021-04-06 insomnia Severe ringing and buzzing in the ears, nausea, headache, lightheaded, diarrhea, insomnia.
69 2021-04-09 insomnia, anxiety 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 2021-04-09 insomnia Three days after my 2nd shot of Maderna I started experiencing skin sensitivity on my right arm. Th... Read more
Three days after my 2nd shot of Maderna I started experiencing skin sensitivity on my right arm. This continued to get worse and 2 days later I was getting pain in the arm. 3 days later I noticed a rash and some pimples. That is when I went to the urgent care. At that point I was told most likely it was the Shingles and that I caught it early. I was given Valacyclovir to take for 7 days. The following day the pimples turned in blisters and were very itchy. Also, the pain in my arm at night at times was almost unbearable. I was on advil to help this. A week after starting the Valacyclovir I was feeling better during the day. Sleeping was still difficult since the pain seem to come after I laid down. Again. I needed to take advil on a schedule to be able to get some rest. As of today, 4/10/21, everything is drying up. Because of the intense pain in my arm, I still need to take the advil at bedtime.
69 2021-04-10 disorientation 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 2021-04-10 nightmare, feeling abnormal Muscle aches, shooting pains, ,nausea, dizziness, fever to 100.2 degrees (lasting one day), pains i... Read more
Muscle aches, shooting pains, ,nausea, dizziness, fever to 100.2 degrees (lasting one day), pains in head and outer ears, chills, brain fog, very strange dreams/nightmares, fatigue, swollen lymph nodes. As of today (04/11/2021) have recovered from all but the brain fog, fatigue and strange dreams.
69 2021-04-12 feeling abnormal Extreme fatigue starting the evening of the second shot. Low grade fever x 1 day, headache entire t... Read more
Extreme fatigue starting the evening of the second shot. Low grade fever x 1 day, headache entire time since shot. Brain fog.
69 2021-04-12 memory impairment, anxiety couldn't talk; memory started to go/ memory was getting worse/ couldn't remember what day it was; tr... Read more
couldn't talk; memory started to go/ memory was getting worse/ couldn't remember what day it was; tried to get out of bed and fell; getting anxiety ridden; Tremor/hand was shaking was dropping things/whole body just shakes; had trouble standing; feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremor/hand was shaking was dropping things/whole body just shakes), DYSSTASIA (had trouble standing), MALAISE (feeling sick), APHASIA (couldn't talk), MEMORY IMPAIRMENT (memory started to go/ memory was getting worse/ couldn't remember what day it was), FALL (tried to get out of bed and fell) and ANXIETY (getting anxiety ridden) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L2DA and 016M20A) for COVID-19 vaccination. The patient's past medical history included Lyme disease. Concomitant products included FAMOTIDINE (PEPCID AC) for Acid reflux (esophageal), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE 40) for Acid reflux (oesophageal), CYCLOBENZAPRINE for Antiinflammatory therapy, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, TRAZODONE for Insomnia, HYDROXYCHLOROQUINE, CLARITHROMYCIN, AMOXICILLIN and DOXYCYCLINE for Lyme disease, PREGABALIN (LYRICA), DIAZEPAM (VALIUM) and CLONAZEPAM (KLONOPIN) for Nerve pain, OXYCODONE and ZOLPIDEM TARTRATE (AMBIEN) 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 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced TREMOR (Tremor/hand was shaking was dropping things/whole body just shakes) (seriousness criterion hospitalization), DYSSTASIA (had trouble standing) (seriousness criterion hospitalization) and MALAISE (feeling sick) (seriousness criterion hospitalization). On an unknown date, the patient experienced APHASIA (couldn't talk) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (memory started to go/ memory was getting worse/ couldn't remember what day it was) (seriousness criterion hospitalization), FALL (tried to get out of bed and fell) (seriousness criterion hospitalization) and ANXIETY (getting anxiety ridden) (seriousness criterion hospitalization). At the time of the report, TREMOR (Tremor/hand was shaking was dropping things/whole body just shakes) had not resolved and DYSSTASIA (had trouble standing), MALAISE (feeling sick), APHASIA (couldn't talk), MEMORY IMPAIRMENT (memory started to go/ memory was getting worse/ couldn't remember what day it was), FALL (tried to get out of bed and fell) and ANXIETY (getting anxiety ridden) outcome was unknown. The patient thought that the tremors might have been due to the Hydroxychloroquine and because she was also feeling sick, she stopped taking the Hydroxychloroquine, but continued taking the Clarithromycin. The tremors continued. Her doctor advised her to resume taking the Hydroxychloroquine, starting with ¼ pill, then ½ pill working her way up in dosing. The patient reported that her hand tremors never stopped. 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 events, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-023753 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: No specific follow-up information recorded.; 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 2021-04-13 feeling abnormal Strange feeling from from my head to my toes, throat starting to close up, Hands went completely col... Read more
Strange feeling from from my head to my toes, throat starting to close up, Hands went completely cold, face & body turned red along with bums all over bodying Took a Zyrtec. Next morning called the pharmacist and she told me to take got Benadryl instead. Also said I should have call 911. Went to doctor the next he told to keep on keeping Benadryl. Rash lasted about 7 days. My face peeled on left side and flaked off my body.
69 2021-04-13 sleep disorder 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 2021-04-15 feeling abnormal, nervousness 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 2021-04-16 anger, feeling abnormal Within 30 minutes: extreme vertigo. Within 1 hr low fever, extremely painful arm, Slept on sofa for... Read more
Within 30 minutes: extreme vertigo. Within 1 hr low fever, extremely painful arm, Slept on sofa for 6 days. Extreme Fatigue continues "Brain Fog" continues Constant raging Tinnitus in rt ear
69 2021-04-17 sleep disorder Tossed & turned all night...woke up 7am w/ chills & weakness & sore arm. Feel feverish. Temp is 99.9... Read more
Tossed & turned all night...woke up 7am w/ chills & weakness & sore arm. Feel feverish. Temp is 99.9. No energy & a little nauseous. Body aches.
69 2021-04-17 sleep disorder Extreme pounding in left ear. Woke me from a sound sleep. Fullness and hearing loss in left ear
69 2021-04-18 feeling abnormal 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 2021-04-19 mental impairment On April 9,2021, around 11:00 in the morning. I suffered an eposide of Transient global amnesia. My... Read more
On April 9,2021, around 11:00 in the morning. I suffered an eposide of Transient global amnesia. My husband notice I was unable to recall events from yesterday, asking repetitive questions of my daughter, I could not remember who the president is and was unable to recall recent events. I was admitted to the hospital for observation. CT head, and labs were ordered. There were no evidence of intracranial hemorrhage, no evidence of CVA/TIA. I was treated for Transient global amenesia and released from the hospital on 4/11/201
69 2021-04-19 panic attack, anxiety Anxiety with panic attack, no vertigo, Face flushed, HR rapid, brought to first aid room and afte... Read more
Anxiety with panic attack, no vertigo, Face flushed, HR rapid, brought to first aid room and after lying down for a few minutes felt better. HR 88, Resp 16 B/P 128/90
69 2021-04-20 feeling abnormal 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 2021-04-21 loss of personal independence in daily activities I had the shot done at 11 o?clock in the morning. I had no side effects until around 6 PM that eveni... Read more
I had the shot done at 11 o?clock in the morning. I had no side effects until around 6 PM that evening. My left arm was in severe pain. I couldn?t even lift it to my shoulder. It was the worst pain I have ever had in my entire life. I couldn?t lift my arm to even wash my hair or brush my teeth. I did some research and found out that the injection was given not in my muscle but in the bursa. According to my research I had an inflammatory effect from the vaccine administration to the subdeltoid bursa instead of the muscle. The severe pain lasted at least four days and I still have pain if I sleep on that arm incorrectly or if I try and use it for extended periods of time. I had no other ill effects from the vaccine.
69 2021-04-23 sleep disorder 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 2021-04-25 confusional state, agitation 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 feeling abnormal 6 days severe headache and vertigo. Brain fog - couldn't think straight. Ibuprofen for headache wi... Read more
6 days severe headache and vertigo. Brain fog - couldn't think straight. Ibuprofen for headache with no effect.
69 2021-04-25 excessive sleepiness After the shot and prior to the event on 4/22/21, was extremely drousy and slept for 3-4 days during... Read more
After the shot and prior to the event on 4/22/21, was extremely drousy and slept for 3-4 days during waking hours. No energy. Then on 4/22.21, at 11:30 am started experiencing stomach pain and upset that went into chills, aches all over, cramps and finally vomiting to the point of dry heaves. After which the vomiting ceased. did not eat solid food for 3 days, just soup and cereal in milk. Ate a chicken sandwich on Sunday afternoon and back on liquid. Stomach still upset. No diareha but excessive powerful fladulation. Took Alkaselser and discovered it has asprin in it. Not sure if is reacting to the Covid shot 2 weeks prior. Still in abdominal distress , dizziness and ringing in the ears. Not sure if reaction to the second Covid shot or something else. Please advise.
69 2021-04-26 disturbance in attention, feeling abnormal second day after vaccine i felt extremely tired, body aches, some congestion , couldn't get out of b... Read more
second day after vaccine i felt extremely tired, body aches, some congestion , couldn't get out of bed , chills and some dizziness, my head felt fluey., dizzy and chills. from third day on I felt body aches , tired and groggy, , felt just not right , not 100% good, now I had a runny nose too. up until that day , i still feel not completely well, body aches, run down , tired, able to hold concentration, runny nose and some chest congestion, tired and groggy.
69 2021-04-26 feeling abnormal, disturbance in attention 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 feeling abnormal "lightening-like" sensation in back of neck, up into back of head upon injection. 12 hours out..feel... Read more
"lightening-like" sensation in back of neck, up into back of head upon injection. 12 hours out..feeling abnormal... chills shortly thereafter, throughout the night. also nausea, headache. Next day, mental confusion, fog.. .lymph glands under arm on right side very tender, some swelling...this continued for at least 3 days.
69 2021-04-26 insomnia 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 2021-04-27 memory impairment, disorientation Arm soreness, then I started feeling like I was drugged, that's lasted now for 2 weeks. I have been ... Read more
Arm soreness, then I started feeling like I was drugged, that's lasted now for 2 weeks. I have been unable to get around, I get lost, I forget to do the simplest tasks. It feels like it's progressing.
69 2021-04-28 sleep disorder Headache. That was sharp shooting pains, like knives stabbing. Unable to sleep for long while. Slept... Read more
Headache. That was sharp shooting pains, like knives stabbing. Unable to sleep for long while. Slept maybe 6 hours. Woke with headache that continued for 3 days. However was more like a severe migraine headache. I honestly thought I was going to die with the initial headache. I will never consider a booster for fear of actually dying. It was awful
69 2021-04-28 sleep disorder Second shot. Woke up at 11:45 pm (Feb. 25) with fever and chills. Took a Tylenol after 45 minutes ... Read more
Second shot. Woke up at 11:45 pm (Feb. 25) with fever and chills. Took a Tylenol after 45 minutes and went back to sleep. Next morning (Feb. 26) at 9:00 am had fever of 100.3, was fatigued, and had little appetite. Took another Tylenol. Sat around all day. By evening was feeling slightly better. Next morning had no fever, most of appetite was back, and felt slightly fatigued, but functioned normally, i.e., took a 2-mile walk, as usual.
69 2021-04-29 abnormal dreams, feeling abnormal MODERNA COVID-19 vaccine EUA 1st day after. arm swollen at inject. site, loose stool, food doesn't t... Read more
MODERNA COVID-19 vaccine EUA 1st day after. arm swollen at inject. site, loose stool, food doesn't taste good 2nd 3x4" RED HOT Patch at inject site. Temp to 99 degrees (normal 97.6 degree) sour stomach, loose stools 3rd 4 am abdominal pains, loose stool- Day in Bed weak upset stomach. Arm less red 7th normal temp & energy, loose stools & gut rumbles
69 2021-04-30 sleep disorder 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 2021-05-06 feeling abnormal 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 feeling abnormal Headache for 5 days, a feeling of ?brain fog?. Minimal activity. After 5 days it went away an... Read more
Headache for 5 days, a feeling of ?brain fog?. Minimal activity. After 5 days it went away and felt fine. After 2nd dose - that night started with chills, warm flushed feeling, all over body aches, headache. These lasted two days then went away. Feel fine now.
69 2021-05-10 depression Buzzing in my ears and flu like sickness extreme fatigue depression
69 2021-05-10 sleep disorder I have Rheumatoid Arthritis but, have not had significant symptoms in many years. About a week or s... Read more
I have Rheumatoid Arthritis but, have not had significant symptoms in many years. About a week or so after my second vaccine I began experiencing some RA type pains in Hands. The pain/flare continued to May 5, 2021 at which time pain was extremely intense to point it was hard to sleep. Pain meds did not help. The next day symptoms had decreased to very minor pain/discomfort. This is slowly getting better but it still present.
69 2021-05-12 feeling abnormal Patient DOD 4/19/21 Death Certificate Line A ?Adverse effect of Covid19 vaccine-5 day interval onset... Read more
Patient DOD 4/19/21 Death Certificate Line A ?Adverse effect of Covid19 vaccine-5 day interval onset and death? Line B ?Anorexia nervosa? Line C ?Recurrent Major Depressive Disorder? Received her second Moderna dose from our Mobile team on 4/14/21 Since then I spoke with Dr. (Mobile); clients PCP, several times regarding this event. His nurse got an email from client on 4-12-21 that client had vaccination planned on 414 and may need to reschedule medical appointment planned 4-16 if she felt bad. The client was encourage to get vaccine and to keep appointment for Friday April 16th. The client emailed the office at approx 0300 Friday morning April 16 to cancel appointment because she felt to poorly from vaccination shot to come in (fevers; body aches). Dr next heard from police officer on Monday April 19th that she was found dead in her home. He requested the Medical Examiner (ME) evaluate but this request was denied. The client lived alone. Dr contacted family members but they did not have much interaction with the client and had no significant information to contribute. Dr said he speculates that the patients underlying anorexia nervosa likely put the client in a critical nutritional deficiencies / electrolyte imbalance condition and the side effects of vaccination were too much. He felt compelled to complete the death certificate as he did because the ME declined the case. From vaccine mobile team notes: team was there2-3:30pm. All the answers to the health screening questions for the patient were "no" except for "have you ever had a severe allergic reaction to something?" To that question the answer was "yes. Immunization Information System record - lot # is underlined: Coronavirus COVID-19, mRNA,LNP-S,PF, 03/17/2021 1 of 2 100 mcg/0.5mL Full 022M20A IM LA Coronavirus COVID-19, mRNA,LNP-S,PF, 04/14/2021 2 of 2 100 mcg/0.5mL Full 006B21A IM LA
69 2021-05-12 sleep disorder 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 2021-05-13 feeling abnormal A few hours after receiving it, I started to feel these horrible aches and pains in my hands (both),... Read more
A few hours after receiving it, I started to feel these horrible aches and pains in my hands (both), arms and upper back. And has not subsided. I'm still having today. It almost feels like I'm having rheumatoid arthritis problems. I'm not swollen. Just pain and stiffness. The pain is in all of these areas and is not moving. I'm miserable. No treatment except Tylenol and sometimes it helps and sometimes it doesn't.
69 2021-05-13 mental status changes Patient developed acute encephalitis and stroke-like symptoms following vaccination, failed SLUMS sc... Read more
Patient developed acute encephalitis and stroke-like symptoms following vaccination, failed SLUMS score at her clinic visit. Symptoms persisted overnight prompting ER visit and admission. Patient had severe COVID-19 in December 2020 requiring 20 day hospitalization, stay was complicated by development of altered mental status thought to be stroke but imaging did not confirm this and it eventually improved.
69 2021-05-15 confusional state 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 2021-05-16 sleep disorder As I got the Moderna 2nd dose vaccine on 4/2, I immediately felt pain shooting up from my left arm t... Read more
As I got the Moderna 2nd dose vaccine on 4/2, I immediately felt pain shooting up from my left arm to my neck on the left side. This was a drive-through clinic & shot was given close to my shoulder. It started w/ minor pain in my arm, neck & shoulders. By 4/30 the pain was so bad that my GP got me muscle relaxers & anti-inflammatory drugs to sleep and function. I was also taking Lunesta & Unisom; sleep was still very erratic. Throughout the day & night I used BioFreeze, arnica, both hot and cold pads and elastic bandages. I was still in pain. Since 5/4, I have seen my chiropractor 3 times and have seen an acupuncturist 4 times which seems to be helping. (Can't get the calendar for Patient died to go away.)
69 2021-05-17 feeling abnormal Swollen arm, redness, rash at injection site. Brain fog that lasted about two weeks.
69 2021-05-17 loss of personal independence in daily activities, insomnia Reports having her first COVID shot in March. She did well x 10 days then became very ill including ... Read more
Reports having her first COVID shot in March. She did well x 10 days then became very ill including nausea/vomiting/diarrhea. She received her 2nd COVID vaccine in early April. Developed the chills the night of the 2nd vaccine. Reports having to use the BR in the middle of the night and could not get out of bed. She reports to this day she feels her arms are "paralyzed." She has had labs and XR's of her shoulders. She was referred to Ortho. She was given an inj into the L shoulder and felt good x 1 day. Pain is worse on the L than the R. She requested an inj for the R as she cannot move her bilateral hands. Reports needing help with dressing, getting anything down from higher cabinets. CRP and Sed rate were very high per care everywhere. She was using Diclofenac but this was not helpful. Now taking Gabapentin TID and Ibuprofen 800 mg almost every 6 hours. She cannot sleep on her sides. Not sleeping well as a result. Reports when she first wakes she cannot even lift her arms or brush her teeth. Has to shower x 20 min to move her arms. She does not want to blame the COVID vaccination but this started after receiving her 2nd vaccine She cannot tell if the Gabapentin is helping. She is very fatigued but cannot tell if this is r/t med or because she is not sleeping. Denies travel, bug bites, tick bites.
69 2021-05-19 mental status changes within 48 hours of 1st dose, mental status changes, slurred speech, weakness within 24 hours of 2nd ... Read more
within 48 hours of 1st dose, mental status changes, slurred speech, weakness within 24 hours of 2nd dose, sudden onset of arm and leg weakness, "in and out of it," layed on the floor for 7 hours until she was able to get up and call for help
69 2021-05-19 sleep disorder On Monday, April 19 tinnitus began in right ear. Very loud, sharp, squealing sound. Ear also felt "f... Read more
On Monday, April 19 tinnitus began in right ear. Very loud, sharp, squealing sound. Ear also felt "full." This lasts all day and I was unable to sleep. I am being treated by acupuncture and herbal formula by a doctor of Traditional foreign Medicine. I had tinnitus (very low, not this severe) in the past and this course of treatment worked. It is improving but I still have this 1+ month on. ADVERSE EFFECTS: unable to sleep
69 2021-05-22 sleep disorder I am reporting this event as *possibly* being related to my 2nd Moderna shot. No one knows for sure ... Read more
I am reporting this event as *possibly* being related to my 2nd Moderna shot. No one knows for sure either way. I feel, however, that if you have received other, similar reports, then this problem may need to be looked into. Beginning two days after my 2nd Moderna injection, I developed constant, severe pain in my buttocks, thigh, calf & foot. When it did not diminish after a couple of weeks, I made an appointment with my doctor, whom I saw on April 22, 2021. She diagnosed my condition as piriformis syndrome, an inflammation of the piriformis muscle that causes it to pinch the sciatic nerve. Nothing showed on an X-ray of my lower back and hips that could account for this. I began a regimen of physical therapy, finally, on May 17, 2021. Although there has been some improvement in the level of my pain, the pain persists. It is particularly unpleasant during the night and often keeps me awake.
69 2021-05-24 sleep disorder This is an update, three months after adverse reaction already filed, temp number 395191, neuropathy... Read more
This is an update, three months after adverse reaction already filed, temp number 395191, neuropathy in left arm with rash continues with intermittent spread to left chest area and occasional nerve pains in feet and ankles. Left arm is still significantly painful, interfering with sleep and arm movement.
69 2021-05-25 feeling abnormal I got my first Moderna shot on May 11th. I was extremely tired the next day and just napped most of... Read more
I got my first Moderna shot on May 11th. I was extremely tired the next day and just napped most of the day. The second day I was a little better but still felt a little drugged. This condition has continued to the point that I am ready for bed by four in the afternoon, a sharp difference from my usual 11:00 pm. Afraid to drive because you might fall asleep at a red light. No prior similar symptoms . Also including periodic slight fevers to 99.3, my normal temp is 96.8, headaches and being extremely cold. Also a lot of muscle aches, everywhere, and dizziness.
69 2021-05-25 sleep disorder I woke up middle of night and I have a weaker numb right leg, but I couldn't move it was paralyzed.... Read more
I woke up middle of night and I have a weaker numb right leg, but I couldn't move it was paralyzed. In the morning I still could not move my right leg. It eventually slowly came back so I could walk but has left it weaker then before I had the shot to this date. I spent 4 days in our condo before I felt I could walk.
69 2021-06-02 insomnia, feeling abnormal not getting any sleep; Involuntary movement of her arms and legs/body is just jerking; Felt like she... Read more
not getting any sleep; Involuntary movement of her arms and legs/body is just jerking; Felt like she was having an alien pop-out/felt like something in her body was squeezing her inside; Cataracts; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Cataracts) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cataract extraction (on her right eye ) on 21-May-2021 and Cataract extraction (on the left eye ) on 06-May-2021. Concomitant products included MAGNESIUM and VITAMIN B12 [VITAMIN B12 NOS] 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) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced CATARACT (Cataracts) (seriousness criterion medically significant). On an unknown date, the patient experienced INSOMNIA (not getting any sleep), DYSKINESIA (Involuntary movement of her arms and legs/body is just jerking) and FEELING ABNORMAL (Felt like she was having an alien pop-out/felt like something in her body was squeezing her inside). The patient was treated with Surgery (Cataract surgery of right eye on 21MAY2021 and of left eye on 06MAY2021) for Cataract. At the time of the report, CATARACT (Cataracts) outcome was unknown and INSOMNIA (not getting any sleep), DYSKINESIA (Involuntary movement of her arms and legs/body is just jerking) and FEELING ABNORMAL (Felt like she was having an alien pop-out/felt like something in her body was squeezing her inside) had not resolved. Treatment information was not provided. The patient was scheduled to a neurologist. 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 increased aged is also a risk factor for cataracts. This case was linked to MOD-2021-185661 (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. However the patient's increased aged is also a risk factor for cataracts.
69 2021-06-03 disturbance in attention, nightmare 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 2021-06-07 loss of personal independence in daily activities, memory impairment, feeling abnormal 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 loss of personal independence in daily activities She got her vaccine, everything was fine that day. 24 hours later is when she started having pain i... Read more
She got her vaccine, everything was fine that day. 24 hours later is when she started having pain in her arm. As the day went by about noon it got worse and had a temp as well, which continued . By Monday 4/22/21 she started getting migraines. The arm pain had gone up her shoulder and into her neck which has been in agony and that set off the migraines. She took Tripen for her migraines, and she knows when she goes blind she takes this medicine. 4 hours later she had to take another one and it was not working and took an Ibuprofen which sometimes helps. Nothing helped and later that day she took a Norco which didn't help either. Finally she went to sleep and woke up throughout the night and the headache kept coming back. She didn't realize it may have been a side-effect of the vaccine and just took her regular migraine medicine, and a couple of days later finally got rid of her headache. She had the migraine from the first one and a few days before the 2nd one she finally got rid of it, and then restarted again. She is now 2 months post vaccine and is still having continuing headaches, not as much but still continuing. She has been getting the headaches every few days and then they last a couple of days. Normally her migraines she has one a week and last a couple of hours and then perhaps about 4 hours and they are bearable and sometimes she doesn't get any depending on the season, winter is worse and is a trigger. The rainy season gets her, but it's not that season and they have been unexpected. Her arm hurt and when she would lift it would go into spasms. She said that it is getting better, but does not want to lift anything. She had weakness due to the reaction and had to hire somebody to get her groceries and clean her house. She did take Benadryl as well throughout her reaction.
69 2021-06-09 sleep disorder I experienced fatigue, headaches, weakness, diarreha, couldn't eat, nausea, achy all over my body an... Read more
I experienced fatigue, headaches, weakness, diarreha, couldn't eat, nausea, achy all over my body and not being able to sleep.
69 2021-06-10 feeling abnormal 24hrs after dose felt like I got ran over by a truck. Fever and body aches. After 24hrs took Tyleno... Read more
24hrs after dose felt like I got ran over by a truck. Fever and body aches. After 24hrs took Tylenol and Plaquenil and felt much better. Then 2 weeks later I developed shingles and I knew that's what it was because I've had it before. It came on strong. I called my primary doctor and was seen the next day. Prescribed me an antiviral treatment course- famtclovir 500MG for 10 days 3x daily. Cleared after the 10 days.
69 2021-06-11 feeling abnormal Chills then fever. Injection site painful with swelling and hot to touch. Fatigue, muscle and joint ... Read more
Chills then fever. Injection site painful with swelling and hot to touch. Fatigue, muscle and joint pain. loss of sense of smell and change of taste. Feeling awful sore throat.
69 2021-06-13 loss of personal independence in daily activities, insomnia Sharp shooting nerve pain that radiates from shoulder to wrist, extreme wrist weakness, hip nerve pa... Read more
Sharp shooting nerve pain that radiates from shoulder to wrist, extreme wrist weakness, hip nerve pain that radiates to back - both on right side of body ( side which shot was given) Weakness of wrist and pain that does not allow me to even turn the ignition key on my car had xrays taken and now MRI scheduled ... extreme difficulty walking and sleeping bc of severe nerve pain
69 2021-06-15 impaired work ability, feeling abnormal, disturbance in attention, anxiety, poor quality sleep Extremely fatigue , restless sleep at night, headache, running fever periodically, but that went awa... Read more
Extremely fatigue , restless sleep at night, headache, running fever periodically, but that went away, I felt like i had the flu, I also have brain fog, trouble concentrating. Went to my psychiatrist and asked if my meds were too strong. He said Medication was fine. My Primary care doctor suggested a sleep study and a cardiac work up because I was having excessive night time sweating which i didn't have prior to my vaccine, and extreme fatigue. I am falling asleep behind the wheel and at my desk at work while someone is talking to me. My anxiety and depression has gotten worse and i am contributing it to everything that is going on.
69 2021-06-16 feeling abnormal I started feeling fatigue later that afternoon, and I was so tired I stayed in bed. I felt bad for w... Read more
I started feeling fatigue later that afternoon, and I was so tired I stayed in bed. I felt bad for weeks.
69 2021-06-17 feeling abnormal 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 2021-06-21 loss of personal independence in daily activities I started having headaches every day and they didn't start from any particular thing. Sometimes they... Read more
I started having headaches every day and they didn't start from any particular thing. Sometimes they would last 15-20 minutes and sometimes they lasted 8-20 seconds and they were mostly over my left eye/left temporal region. Eventually I just stopped having them. I did talk to my Doctor and I did go to urgent care and they drew a COVID Test and a bunch of lab work. They also did an MRI of brain and they found nothing structural or obvious. It didn't feel like tension headaches, they were sharp pains behind eyes. I went to eye doctor and got prescription for my glasses changed but it wasn't in that eye. Sometimes they were disturbing enough to stop me from doing what I was doing. This lasted about six weeks. I have recovered from the headaches. I did have itchiness and swelling in L arm from both vaccines. I didn't have anything else happen.
69 2021-06-22 feeling abnormal 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 2021-06-24 euphoric mood 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 2021-06-27 feeling abnormal 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 2021-07-01 confusional state 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 2021-07-04 impaired work ability Unable to work the two days following the second injection. Random, extreme piercing pain in left... Read more
Unable to work the two days following the second injection. Random, extreme piercing pain in left rear hemisphere of the brain began two weeks following the second injection. There is no regular time that this occurs. Episodes may be close together and then not occur for days. There is no regular time of day or night. Patient has expressed a fear of not waking when these episodes occur near bed time. Pain has brought patient to tears on occasion. First visit to regular physician on June 1, 2021. Follow-up visit to be scheduled. Symptoms continue.
69 2021-07-07 amnesia, loss of personal independence in daily activities, impaired work ability A few hours after receiving the vaccine, I became very tired and I had to lay down. I started to get... Read more
A few hours after receiving the vaccine, I became very tired and I had to lay down. I started to get chills and a high fever. For 2 days, my neighbor had to come stay with me because I couldn't do anything for myself and I don't remember anything. My children came down as well, and after the fourth day, I felt fine. I am still feeling fatigued since then. A couple weeks later, I started to realize that I wasn't able to really eat or drink anything. I went to three different Urgent Cares within about 12 days. The first Urgent Care told me that I probably had an infection of some sort. They gave me a shot of prednisone and gave me a prescription for a 5-day Z-Pack. They told me to take it within 3 days. After 3 days, I did not feel any better. I wasn't able to be seen at the second Urgent Care. At the third Urgent Care they said they thought I had strep throat. A friend of mine gave me something called "magic mouth" to numb my tongue so I could drink something. I had to miss a couple days of work and I'm now going on two weeks without really eating anything. I went to a medical facility. At the ER, they gave me fluids and they did a CT scan on my head to rule out a stroke. They drew a lot of blood. I have seen the Doctor twice and he wants to do a CT scan on my lungs. I have gone to an ENT and there is something going on in my throat. There are damages that have been found, but they still need to come up with a treatment. I keep having moments where I'm repeating myself. I'm going to be going to a neurologist to find out if there is any issue with my brain.
69 2021-07-13 insomnia 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 2021-07-14 agitation, insomnia, hallucination 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 2021-07-17 memory impairment 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 2021-07-21 feeling abnormal, amnesia The 2nd day after my dose of moderna i noticed my brain wasn't working very well as if some body too... Read more
The 2nd day after my dose of moderna i noticed my brain wasn't working very well as if some body took a vacuum cleaner and took out the information with out my permission. I've gotten loss several times in my own city where I live. it's just continued and there are days i feel are better than other days but i never know what I'm going to get when I wake up. it's continued, i saw my doctor in may about a month after the second shot and he explained that some patients that had covid and then got the shot have had this brain fog. he was a little familiar with it, not a lot. I've gone to physiatry to figure out how to live with it cause i live alone cause you can't take something to change it. I've passed the 3 months of having it cause i still have it. i'm waiting to see a doctor when he is back from vacation. it's basically as if i have Alzheimer's or dementia over night, very similar symptoms. I have a new symptom that started in april that i just ignored that i didn't make a connection to, it's almost as if i have a paper cut all over my finger tips, it comes on and lasts a couple of minutes every week. and it burns. then it's gone. and i didn't put the two together in april.
69 2021-07-27 irritability, feeling abnormal 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 feeling abnormal After the first shot mild fatigue from 2-3 day post vaccination, up to the second vaccination. Afte... Read more
After the first shot mild fatigue from 2-3 day post vaccination, up to the second vaccination. After the second dose of the vaccine to the present time EXTEME FATIGUE AND DISSINESS ALL DAY LONG, along with a FOG FEELING IN THE HEAD ALL DAY LONG. tHIS IS going on up to today ,July 29, 2021, when will it get better ?
70 2021-01-05 feeling abnormal, impaired work ability Headache Received shot at around noon - felt really tired/fatigued/"wilty" worn out hours later that... Read more
Headache Received shot at around noon - felt really tired/fatigued/"wilty" worn out hours later that afternoon which lasted for the next 3 days. Woke up with moderate headache next morning, if had to work that day, would not have been able to.
70 2021-01-06 incoherent Vaccine Candidate received vaccine approxat 2:30pm, was monitored for 15 min no complications at the... Read more
Vaccine Candidate received vaccine approxat 2:30pm, was monitored for 15 min no complications at the time, went home. Around 5:30pm while walking into her home she became unresponsive, was assisted in a siting position, became incoherent, mumbling and started to convulse to the right side of her r upper extremity. Foaming at the mouth and stopped breathing, CPR was initiated for 1-2 min, EMS arrived was transported to Medical Center. She was admitted and is currently hospitalized. MD reports this event is highly unlikely related to the vaccine given her medical history but suggested to report being its a new vaccine. Current status: stable.
70 2021-01-07 feeling abnormal 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 2021-01-07 sleep disorder The patient came into the pharmacy the morning following her vaccination 1/8/21 complaining of extre... Read more
The patient came into the pharmacy the morning following her vaccination 1/8/21 complaining of extreme pain on her right side near her ribs, stomach and lower back. She experienced this pain the same night of receiving her vaccine, and it disrupted her sleep. She also complained of difficulty breathing up on inhalation, saying that it hurts to inhale.
70 2021-01-08 sleep disorder Moderna COVID-19 Vaccine EUA Although I had arm pain bad enough to wake me in the night 30 and 31 De... Read more
Moderna COVID-19 Vaccine EUA Although I had arm pain bad enough to wake me in the night 30 and 31 December, that was not surprising. What surprised me is that the site (about 9 cm round) became very red and very itchy a full week later (01/05/2021) and is still pink and itchy now. This is not at all serious, and Benadryl cream reduces the itching. I am reporting it only because it is not listed as a side effect on the documentation or CDC website.
70 2021-01-12 loss of personal independence in daily activities, impaired work ability I felt fine until the morning of Jan. 10 (except for very painful arm). I was awakened early in the... Read more
I felt fine until the morning of Jan. 10 (except for very painful arm). I was awakened early in the morning by severe vertigo (my eyes were blinking rapidly and the room was spinning violently); I was nauseous and couldn't lie down without the violent spinning re-occurring. I was very dizzy and exhausted the whole day, unable to function. The next day I continued to be very dizzy and off-balance, couldn't work but better than prior day. Each day, same symptoms have continued but milder. I called my PCP on Monday, Jan 11. He told me it sounded like an inner ear problem, probably unrelated to the vaccine and to call him the next day and report my symptoms. I did (Tues. Jan 12) and reported dizziness was milder but still there. He suggested I see an ENT doctor.
70 2021-01-14 irritability swelling, itching, redness, welps, irritation
70 2021-01-18 sleep disorder Awaken from sleep at 3 am 1/17 with severe headache, chills, shaking., severe thirst. Severe fatigue... Read more
Awaken from sleep at 3 am 1/17 with severe headache, chills, shaking., severe thirst. Severe fatigue and aching in back and legs. Took 200 mg Advil. Slept for entire 12 hours only getting up to bathroom. By 5p fatigue liefting. Headache remained. Additional 200mg Advil. By 1/18 fatigue 80% gone. Headache lifted. By end of the day back to 100%
70 2021-01-20 insomnia Sore arm the first morning About 26 hours after injection I became cold. 2:00pm at 28 hours my teeth... Read more
Sore arm the first morning About 26 hours after injection I became cold. 2:00pm at 28 hours my teeth began to chatter uncontrollably. 4:00pm until 8;45pm - I had 4 tylenol during this time frame Became very achy and uncomfortable around 8:45 pm At 1:00 am I felt inflamation on my whole left side. My arm hurt to the shoulder to touch or move, left breast sore, left knee (artifical replacement) was sore under knee cap. I took two extra strength tylenol for inflamation and slept for 2 hours. Woke up in a pool fo sweat, but felt fine! Should I take the second dose?
70 2021-01-20 mental impairment Started becoming very warm while resting in bed getting ready for sleep. Fell asleep and woke up a l... Read more
Started becoming very warm while resting in bed getting ready for sleep. Fell asleep and woke up a little while later sweating from head to toe and trembling. Thinking was hard, but not actually confused. I thought maybe I needed to eat something because occasionally I have low blood sugars (not diagnosed) and get sweaty and nauseated. I wasn't nauseated but thought I'd try to eat something anyway but couldn't. The mental fog was very disconcerting. I don't know how long the sweat lasted but probably not more than 5 minutes. When it started abating, I laid down again and fell asleep. I didn't have any after effects when I woke up again. This may have nothing to do with the vaccination of course.
70 2021-01-20 restlessness Restlessness, headache, swollen left cheek, elevated heart rate.
70 2021-01-21 feeling abnormal Within an hour after injection, my face, around my mouth, felt a tingling and slightly numb. Insid... Read more
Within an hour after injection, my face, around my mouth, felt a tingling and slightly numb. Inside of mouth felt strange. I did not have trouble breathing or swallowing. Symptoms gradually went away and later in the day I had a headache.
70 2021-01-22 excessive sleepiness Aching at site, 1am. 4 on a scale of 1-10 vomiting 7am aching and fever 100.2 swe... Read more
Aching at site, 1am. 4 on a scale of 1-10 vomiting 7am aching and fever 100.2 sweating (10) drank water had chicken soup. took 2 tylenol (500 mg) Thursday continued, , 1am -mid afternoon, woke up, then slept 20 hours Friday Jan 22, 2021 Not as much sleeping aching (7) fever down. Called the Clinic, my doctor 1x, NW Specialty Hosp 3 x Normal doses of insulin. 14 units, 7pm, Tresiba, Wed. Thurs and Friday.
70 2021-01-22 insomnia, poor quality sleep Symptoms started on Saturday morning (1/16/2021) following the shot having been administered the pr... Read more
Symptoms started on Saturday morning (1/16/2021) following the shot having been administered the previous day (1/15/2021) at 1:00 p.m. in the afternoon. Initially, I had a slight, constant headache and "medium" fatigue. I dismissed it as not important because it was relatively minor. and I am generally fatigued at the end of a work week. The headache lasted all day but was fairly low level. I did not sleep well that night but was able to function during the next day (1/17/2021) without a problem. I don't remember if the headache was present that day. However, on Sunday evening (1/17/2021) (around 6:00 p.m. or so) chills started to go up and down my body and my hands were very cold. I had no fever. I added more garments to keep warm and ignored or was distracted by my activities of the evening. Monday (1/18/2021) during the day the chills continued to go up and down my body intermittently-- not really staying in one place -- but my hands remained very cold. It should be stated that I prefer colder temperatures; i keep my house between 60-62 degrees in winter and I am able to stay comfortable with a shirt and sweater in that environment. So, on Monday, the fact that I had chills was remarkable to me. The chills were intermittent. Tuesday (1/19/2021) I worked from home all day and had an electric heater going focused very closely on my body all day. I was cold but don't remember having chills. Tuesday evening the chills returned, along with a significant headache that circled my head (not focused in one spot), my body ached, my eyeballs ached; I had intestinal cramping .and I simply could not get warm due to the constant "full-body" chills. I went to bed with a heated mattress pad on, flannel sheets, a comforter an d a thick wool blanket. I could not get warm. I was not able to sleep at all the entire night due mostly to the (major) physical discomfort and (minor) worry as to what was going on. I DID NOT have a fever. Around 8:30 on Wednesday morning, I was able to fall asleep as the chills had diminished and I was worn out. The body and eyeball aches were still present as was the intestinal cramping. Later that afternoon the symptoms started to diminish and I was able to sleep Wednesday night. I did not eat anything on Wednesday as I was not interested in food due to the discomfort of the intestinal cramping. I was able to smell food and had not lost my sense of taste. Thursday morning (1/21/2021, I finally felt like I could eat and had some food which tasted delicious to me. I was able to get warm, had slight headache, cramping was mostly gone, ..I still had (reduced levels) body aches and eyeball aches. I had no chills. I was able to consume and tolerate reduced amounts of food. Friday (1/22/2021) I was tired but able to function and felt as if I was returning to feeling like myself. Today, Saturday(1/23/2021, I am feeling about 95% myself and relieved to have this behind me. I am very concerned about how I might react to the second dose of the vaccine. I am going to consult the local hospital and my PCP there to inquire about the advisability of getting the second dose.
70 2021-01-24 feeling abnormal 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 feeling abnormal starting on 18th feeling bad no energy, didn't wanna get out of bed arm still sore on 21st upper lef... Read more
starting on 18th feeling bad no energy, didn't wanna get out of bed arm still sore on 21st upper left arm was swollen and hot had red streaks started moving down the elbow very painful called doctor on morning of 22 nd spoke to nurse they advised to seek medical attention. CBC done, no cellultitis indicated so gave prednisone 10mg 1 twice a day for 5 days, pepcid ac 20mg 1 tablet twice a day for 7 days, benadryl 25mg as needed for itching. diagnosed allergy unspecified to initial encounter t78.40xa-uncomplicated
70 2021-01-24 feeling abnormal I received the first dose of the covid-19 on Wednesday., Jan.17th at approximately 3p.m. I did fie a... Read more
I received the first dose of the covid-19 on Wednesday., Jan.17th at approximately 3p.m. I did fie and waited until the had a chance to check the sight. I was fine all night and until two days later. I had the chills and a sore arm. When I awakened Saturday morning my arm was red and warm. I did not feel badly. I have had the redness and slight warmth each day. I went to the dr. on Monday. She thinks it is fine but ordered a low does steroid and oral cream. I decided to wait on the steroid for a few days as I am not feeling badly. My arm is still lightly red and slightly warm. I have no heart palpitations or other side affects. It is not blistery.
70 2021-01-24 loss of personal independence in daily activities 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 2021-01-25 anxiety The patient was being observed for 15 minutes post vaccine administration and she started having a t... Read more
The patient was being observed for 15 minutes post vaccine administration and she started having a tingling feeling in her left arm, feeling like her blood pressure was going up and feeling anxious. No shortness of breath, chest pain, swelling of the tongue, mouth or throat, speech appeared normal
70 2021-01-25 anxiety Tingling in the left arm, feeling warm, anxious. No shortness of breath, chest pain, headache, swel... Read more
Tingling in the left arm, feeling warm, anxious. No shortness of breath, chest pain, headache, swelling of the tongue or throat. During the 15 minute observation period following the administration of the vaccine
70 2021-01-25 nervousness, feeling abnormal 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 2021-01-26 sleep disorder Unable to sleep the night I received the vaccine, which was Jan. 25, 2021. Fever varying from 99 to ... Read more
Unable to sleep the night I received the vaccine, which was Jan. 25, 2021. Fever varying from 99 to 102.3 degrees on Jan. 25, Jan. 26, and one-half day of Jan. 27, 2021. loss of appetite.
70 2021-01-28 anxiety 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 2021-01-29 confusional state 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 2021-01-29 feeling abnormal After I waited the required 15 min. before I could leave, my husband and I went to our car and I sta... Read more
After I waited the required 15 min. before I could leave, my husband and I went to our car and I started to feel lightheaded and dizzy. Figured this was normal so continued home. For the rest of the that day I felt lightheaded, dizzy and just wonky off and on the entire day. I later felt exhausted, like someone flipped a switch on me, around 3:00 pm and took a nap for 2 hours. After the nap I felt nauseous and like I was going to vomit. I ate dinner and later in the evening, I took some allergy medicine and felt a little better and went to bed. The next day, Friday, I felt a little dizzy and lightheaded and again felt like I was going to vomit in the morning. I ate breakfast, felt nauseous, started cramping, had diarrhea and was then fine. No more symptoms after that. Although my arm is still tender today, Saturday.
70 2021-01-29 feeling abnormal Coming home. I did not recognize a street I was on. It was on a street that I always drive on. My ... Read more
Coming home. I did not recognize a street I was on. It was on a street that I always drive on. My husband, was driving. He had the shot 15 minutes before me. Same lot. He was really more out of it. We had brain fog for about 4 hours. We rested.
70 2021-01-29 sleep disorder, feeling abnormal Woke up at 3 am with the worst chills I have ever experienced. I can usually do deep breathing or r... Read more
Woke up at 3 am with the worst chills I have ever experienced. I can usually do deep breathing or relaxing to calm my chills, but these would not let up. It felt like my body was being squeezed. I was finally able to get up and used a walker to get to the kitchen and took 1000 mg acetaminophen. Without the walker, which I don't usually use, I was afraid I would not be able to stand up or would stumble due to my shaking. By 4 am, the shaking had stopped enough for me to lay back down and I was able to get to sleep. I had a fever of 99.8 when I woke up. Later that morning it was 100.8. By that night it had gone down to 98.7 and the next morning it was my normal 97.6 and I feel great.
70 2021-01-31 anxiety see above
70 2021-02-01 confusional state 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 2021-02-01 feeling abnormal 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 2021-02-02 feeling abnormal Two days after my injection I had extreme shoulder, arm, back, neck and head pain. It lasted until t... Read more
Two days after my injection I had extreme shoulder, arm, back, neck and head pain. It lasted until the morning of 1/27. On the 1/31 my arm that was injected swelled up, turned red and itched, with minor pain. I called my doctor after a couple days of feeling bad and she advised me to take acetaminophen 2 tabs every 6 hours. It barely lessoned the pain. I went to the doctor this morning because my employer recommended that I did and she said that my arm looked like I had cellulitis.
70 2021-02-03 disorientation Possible TIA. Patient had slurred speech and disorientation on Tuesday morning
70 2021-02-04 feeling abnormal don't know if my issues are related to vaccine Feb 1 - 5 days after shot - intense headache, pressu... Read more
don't know if my issues are related to vaccine Feb 1 - 5 days after shot - intense headache, pressure , fuzzy head, slight visual disturbance - lasted about 15 min. - then subsided Feb 2 strong headache - approx 10-15 min Feb 3 strong headache - pressure approx 10-15 min Feb 4 mild headache Feb 5 slight headache -
70 2021-02-04 sleep disorder stiffness and pain lower back left hip achiness trouble sleeping, tired intermittent bloating
70 2021-02-07 feeling abnormal At 5 am on Friday 2/5/21 I was having chills but I had been sweating and my sheets and pillow case w... Read more
At 5 am on Friday 2/5/21 I was having chills but I had been sweating and my sheets and pillow case were wet. I took my temperature and it was 99.7 and then I took it again later when I started feeling much worse and my temp at 10am was 101.8. I took Tylenol and I went to sleep. I woke around 12:30pm and I was freezing to death! I had a horrible headache! I had chills and fever. every joint and bone in my body ached. I had a floating feeling in my head. I felt real unbalanced and very strange feeling like I was underwater. I would not have felt safe driving or standing up. I drank fluids, and I took my temperature around 3pm and it was 101.1 and I took more tylenol. I had no appetite. At 6 pm I took more tylenol. I went to bed at 11pm and the next morning I was feeling the same way. I had a low temp of 99. I still had no appetite. I went to bed that night (saturday night) I woke up every hour on the dot feeling very sick. I stayed in bed all day sunday as well. I started feeling better as the day went on. I noticed 2 red circles nickle sized on my arm about 3 inches below where I got the shot. I noticed it saturday and its still there. I feel fine today 2/8/21. its very hot to the touch.
70 2021-02-08 nervousness Severe and intense abdominal cramping starting 6 hours after shot Nauseated but no vomiting starting... Read more
Severe and intense abdominal cramping starting 6 hours after shot Nauseated but no vomiting starting 6 hours after shot Shaky, light headed and flushed starting 6 hours after shot Excessive bowel movements, then diarrhea for 10 hours after shot Waves of repeated cramping and diarrhea until bloody stools for 8+ hours after shot
70 2021-02-10 feeling abnormal 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 loss of personal independence in daily activities She woke me at about 4:15am and told me she was freezing, she was shivering in the bed even though s... Read more
She woke me at about 4:15am and told me she was freezing, she was shivering in the bed even though she had a blanket on, so I went and got her another blanket and put some socks on her feet. She went back to sleep until about 6:30am when she woke up and said she felt like she was burning up, so I took 1 blanket and her socks off. I took her temperature at 6:45am and it was 100.2 degrees, so I went to the store to buy her some Tylenol. I gave a cracker and a Tylenol with a glass of water. She went back to sleep until 9:45am, when she woke back up and I took her temperature, it was at 99.7 degrees, she ate another cracker and drank some water and some Diet Coke. She went back to sleep and at 11:35 she woke up and told me she was hungry so I made her some chicken noodle soup and 1/2 of a hotdog. Her temperature at that time was 98.6 degrees. Basically she was in bed the whole day and couldn?t do any of the things that she normally would do. She feels some what better today, no fever, but still has body aches and pains. Her arm is still bothering her and she has a rash at the injection site.
70 2021-02-11 feeling abnormal 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 2021-02-13 amnesia Headache, Dizzy, Slurred speech, Memory Loss, High Temperature
70 2021-02-14 feeling abnormal Shot initially hurt at injection time, unlike 1st injection. By 2pm, could not lift arm without sev... Read more
Shot initially hurt at injection time, unlike 1st injection. By 2pm, could not lift arm without severe pain. Around 6pm, developed serious chill and could not get warm. So cold did not take off clothes and put two heavy robes over clothes and covered with heated blanket. Remained cold until around 5 am and was burning up at that time. Temp was 101.3. Had headache from hell and my body felt as if it had been beaten with worse pain in shoulders, upper and mid back and left knee. Interesting because shoulders have been previously injured and are in poor shape and recently had injured left knee. Don't know if relevant or if existing pain was amplified by effects of virus. With tylenol and aspirin, got temperature to 100 to 1. Felt bad all day Saturday and only got up to go to bathroom and eat bowl of soup. Pushed fluids. By Sunday morning, temp running 99.8 to 100.5 with meds. Pain and h/a continued with slight improvent in h/a. Today, Monday, I feel about 50% better. Temp 98.8 to 99.5. Headache at about 50% of previous level with body aches only slightly improved. Hopefully, I am coming to the end of this reaction
70 2021-02-14 feeling abnormal began to feel foggy headed which came and went on day 2. On day 3 the foggy head also came with naus... Read more
began to feel foggy headed which came and went on day 2. On day 3 the foggy head also came with nausea. Persisted off and on all day. When I went to bed around 11:30 pm that day I began to feel like I was inside a closed up box. This persisted and disappeared around 3 am on the 4th morning and hasn't returned
70 2021-02-14 loss of personal independence in daily activities Approximately 12 hours after receiving the second injection I awoke at 2:00AM with uncontrollable fu... Read more
Approximately 12 hours after receiving the second injection I awoke at 2:00AM with uncontrollable full body shaking to the extent I could not use my phone to call anyone for help. I was absolutely unable to care for myself. The shaking continued for several hours subsiding for a brief period before the chills and nausea began. The pattern of extreme shaking, chills and nausea continued for 12 hours. I am naturally hot natured and keep my thermostat at 63-65 degrees F. The chills were so intense I increased the heat to 70 degrees F and required 8 blankets for relief. I never had an elevated temperature. A few hours later in addition to the chills and nausea, a headache began than morphed into a full migraine that lasted approximately 24 hours before returning to a regular headache. My upper arm felt as if I had been beaten with a baseball bat and could not lift above my head. Approximately 48 hours after the initial side effects commenced I awoke fully drenched in sweat, no elevated temperature and completely exhausted. I knew in advance of the possibility of side effects but not to the severity I experienced.
70 2021-02-15 insomnia SEVERE ACHING, UNABLE TO SLEEP ALL NIGHT, CHILLS, NAUSEA. STARTED AT 10 PM DAY OF INJECTION , SYMPT... Read more
SEVERE ACHING, UNABLE TO SLEEP ALL NIGHT, CHILLS, NAUSEA. STARTED AT 10 PM DAY OF INJECTION , SYMPTOMS LASTED 24 HOURS (IT FELT JUST LIKE THE SYMPTOMS WHEN I HAD THE SNIFFLES AND ALL THE OTHER SYMPTOMS AND GOT TESTED FOR COVID-19 1/23/21 AND TESTED POSITIVE. I GOT THE FIRST COVID-19 VACCINE ON 1/15/2021 LOT # 041L20A (LEFT ARM). SO NOW I WONDER IF THE 1/23/021 SYMPTOMS WERE ACTUALLY A RESULT OF THE FIRST VACCINE.
70 2021-02-16 feeling abnormal 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 sleep disorder Shortly after receiving injection arm was very sore. By evening arm was extremely painful to move or... Read more
Shortly after receiving injection arm was very sore. By evening arm was extremely painful to move or touch. Difficult to sleep due to pain. Day after injection arm was very sore, also felt body aches, headache and fatigue.
70 2021-02-17 confusional state Patient is pron to seizures. She received the Covid shot. At about 4:00 pm that afternoon she began ... Read more
Patient is pron to seizures. She received the Covid shot. At about 4:00 pm that afternoon she began to have a seizure. I was very atypical of her previous seizures. She began the seizure at a very low level (no outward signs other than total confusion and unable to speak. This condition lasted until about 8:pm. Now and again she would do her normal "shake". The seizure eventually stopped. Additional dose of Keppra was given as well a a few drops of Lorazapam.
70 2021-02-17 feeling abnormal, mental status changes, amnesia 2/9: Received vaccine 2/12: Brain fog - actions disassociated from thoughts 2/14: Altered mental st... Read more
2/9: Received vaccine 2/12: Brain fog - actions disassociated from thoughts 2/14: Altered mental status - in a "fog"; transported to ER via ambulance; neuro exam , diagnostics (CT with & w/o contrast, CTA, CT perfusion, MRI, EEG), COVID -19 PCR, blood work/urine - all negative for intracranial bleed/stroke/tumor, ischemic changes, perfusion issues, seizures, COVID, etc. Diagnosis: Transient Global Amnesia (TGA). Admitted overnight. Amnesia event lasted 7hrs from onset and mental status returned to baseline with no residual effects. The 7hr amnesia period is unable to be recalled.
70 2021-02-18 sleep disorder Right upper arm pain at a 9 on scale of 1 to 10 woke me up at 12:40 AM 2/18/2021. at 6:00 AM took 1,... Read more
Right upper arm pain at a 9 on scale of 1 to 10 woke me up at 12:40 AM 2/18/2021. at 6:00 AM took 1,000 mg of Tylenol for pain brought it to a 3 if I didn't move arm. Continued at a level 7 on 2/19/2021 at 5:30 AM too 500 mg Tylenol and at 6:00 AM took another 500 mg. Pain continues now at 7:17 am at a level 2. 2/18/2021 diarrhea began about 8:00 am and continued until about 11:00 am. It wasn't severe but between the two side effects I could not go to work .
70 2021-02-19 agitation 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 feeling abnormal, excessive sleepiness Feb 17th- SORE ARM lasted until Feb 18 - lasted about 24 hours. [moved the arm around and waited] F... Read more
Feb 17th- SORE ARM lasted until Feb 18 - lasted about 24 hours. [moved the arm around and waited] Feb 18- sudden onset of NAUSEA at 5pm. Upset feeling lasted until Sat. morning (20th). [Stopped eating. Switched to BRAT diet, ginger ale. waited.] Resolved by Saturday morning . 19th- nausea continued. Fatigue set in - took a long nap. In the evening, my thinking was foggy. Nausea still present. I rested. Took it easy. SAT morning, the 20th. Things seem to be resolved/resolving. My mind is cleared up. Nausea abated.
70 2021-02-21 feeling abnormal Bad headache, chills, low fever night of injections. Followed by 2 days of major fatigue and brain ... Read more
Bad headache, chills, low fever night of injections. Followed by 2 days of major fatigue and brain fog.
70 2021-02-21 mental status changes 5-7 days after injection Rash, altered mental statues, shortness of breath
70 2021-02-21 sleep disorder 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 2021-02-22 feeling abnormal Moderna COVID-19 Vaccine EUA First symptoms appeared about 8PM the evening of the shot - a feeling ... Read more
Moderna COVID-19 Vaccine EUA First symptoms appeared about 8PM the evening of the shot - a feeling of being weighted down, with extra difficulty in moving about. I went to bed early and when I woke up I had a fever of 101.5 accompanied by chills, body aches, nausea, fatigue, brain fog, and headache. Over the course of two days, my temperature ranged from 101.5 to 103. After two days my fever broke during the night. I did not want to take fever reducing medication in case it interfered with the immune response, but I did take 1 dose each of Tylenol and Motrin over the course of the 2 days. Still felt a bit sluggish on the 3rd day and continue to have brain fog 6 days later.
70 2021-02-22 poor quality sleep Lightheaded, headache, upset stomach, sore arm , within 30 minutes post vaccine. tired. Poor sleep q... Read more
Lightheaded, headache, upset stomach, sore arm , within 30 minutes post vaccine. tired. Poor sleep quality at night after vaccine. Chills, Fever and scratchy dry throat began about 10 hours post vaccine. Fever of 100.4 lasted about 18 hours. Loose stools after about 24 hours. Ear ache and tender neck lymph nodes began after 24 hours. dry throat lasted 48 to 72 hours.
70 2021-02-23 anxiety Throat closed up Pt was brought to ED after receiving covid vaccine number 1 approx 40 min prior to ... Read more
Throat closed up Pt was brought to ED after receiving covid vaccine number 1 approx 40 min prior to arrival. Pt states she started feeling some mild tightness in her throat. Pt denies any trouble breathing. Arrives tearful and appears anxious. No rash noted. No facial swelling or mouth swelling noted. Pt states she did have a mild reaction to flu vaccine and bee stings. Carries any epi pen but did not use it. Patient returned to baseline and was sent home- no acute distress, lungs clear Patient allergies: bee venom (not specified) , ciprofloxacin (rash, swelling), iodine (hives), bactrim (swelling), cephalexin (not specified), procaine (not specified)
70 2021-02-23 insomnia I felt the injection fluid go into my arm with pain and a few hours later my arm pain was so severe ... Read more
I felt the injection fluid go into my arm with pain and a few hours later my arm pain was so severe I could not even move my arm without excruciating pain. I could not sleep or lay down. I had to pack my upper arm with ice for 72 hours. I have had flu shots before and never had a painful reaction that brought tears to my eyes for 72 hours. I don't know what size the needle was used on me, but it almost felt like it hit the bone. I am a thin person. It probably did not hit the bone, but it felt like the fluid was forced into the muscle. My husband did not have this same reaction, so I don't know if it was the person who gave the shot, or wrong needle size or what made my arm hurt like it was hit with a hammer. I now have slight itching at the shot site and there is a bump the size of a mosquito bite.
70 2021-02-23 sleep disorder With shot # 1. Intense pain in the vaccinated arm, extending from hand to left, back shoulder blade... Read more
With shot # 1. Intense pain in the vaccinated arm, extending from hand to left, back shoulder blade starting a couple hours after the shot. Unable to sleep. Day two, used ice pack to attempt to move the arm, which only wanted to stick next to the body and not move. Attempts to use the arm were excruciating, so nothing worked on that level. Continued icing throughout day 2. End of day 2, took an Aleve and continued to ice the shoulder. Day three, took an Aleve; no improvement in the morning, then saw some improvement throughout day three, but not to the point of being able to use the arm. Total focus was on that arm. Day 4, pain improved to being able to use the arm for small tasks. Day 5, pain [but for injection sight] gone. Shot #2. Effects were entirely different but equally intense.
70 2021-02-24 amnesia, confusional state Patient states that 2 days after receiving vaccine, she has no memory of the events. Her spouse stat... Read more
Patient states that 2 days after receiving vaccine, she has no memory of the events. Her spouse states that she was confused and weak and was taken to the ER and given IV fluids. It took a few days before the confusion resolved. The Hospital and MD told her it was a reaction to the vaccine and advised her to not obtain the second dose.
70 2021-02-24 anxiety 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 2021-02-24 feeling abnormal At about 7 am, Sun., 2/21/21, as I was getting out of bed, I noticed that the skin of my left lower... Read more
At about 7 am, Sun., 2/21/21, as I was getting out of bed, I noticed that the skin of my left lower leg was a dusky red. There was no pain or discomfort but my leg felt warm to the touch. Within an hour, the redness had spread to cover all skin between my knee and ankle, however, by noon it was back to normal. At 2:30 am, Mon., 2/22/21, I awoke with abdominal pain, diarrhea, headache, and overall feeling poorly. There were two episodes of diarrhea in the next 8 hrs but abdominal pain disappeared. There were several sharp bursts of headache pain but this pain also disappeared in the next 8 hrs.
70 2021-02-24 feeling abnormal Joint pain, Muscle discomfort Fever (began at 99.2 and rose to 100.6 for the remainder of the day, f... Read more
Joint pain, Muscle discomfort Fever (began at 99.2 and rose to 100.6 for the remainder of the day, followed by sustained spike the next day up to 101.2, leveled off and began to reduce the following day first to 100.4 and then to 99.4 until it broke) Arm pain (could not lift arm for several days, felt like joint was locked; pain, discomfort continued for almost 2 weeks; still feel a little tightness but can finally get my arm raised over my head) Fatigue, tiredness (lasted beyond the fever stage for over a week) Chills (felt like I was in a deep freeze) Site itchiness, odd sensation during week 3 Did not take any Tylenol or any other similar medication either before the injection or afterward, even to this day.
70 2021-02-24 insomnia Could not sleep for 2 nights (Thursday and Friday). Fever, chills, top fever 102.1; splitting headac... Read more
Could not sleep for 2 nights (Thursday and Friday). Fever, chills, top fever 102.1; splitting headache that was worse when I tried to lie down, so ended up resting in a reclining chair but unable to sleep. Fatigue. Loss of appetite. Very thirsty. Arm where injection received was tender and started to ache within a couple of hours of the injection. Tenderness and aching in arm continued for three days. Fever resolved on 2/20/21. Was able to sleep that night.
70 2021-02-25 confusional state, mental status changes, amnesia Confusion and weakness in muscles upon awakening. Mental status changes as well and achiness in join... Read more
Confusion and weakness in muscles upon awakening. Mental status changes as well and achiness in joints. Patient fell but does not remember falling or being on the floor. Patient reports falling 3 times in 2 days. These symptoms are all abnormal for patient.
70 2021-02-25 feeling abnormal on morning or 1/27/2021 and 2/24/2021 I began to feel flu like symptoms (expected) . As the day pro... Read more
on morning or 1/27/2021 and 2/24/2021 I began to feel flu like symptoms (expected) . As the day progresses my fever increased to 101.4 and I took ibphone and drank liquids. Sever headache, body aches, chills both days. On 1/27/2021, my thoughts were a little foggy but did not try top communicate with anyone so not sure inability to communicate happened on 1/27/2021. On 2/24/2021, around 4 PM I got out of bed and stood beside the bed. Unable to support myself and slumped on the floor. Unable to get back in bed or help anyone to get me back in bed. My son called while I was on the floor and I was not able to form sentences to communicate with him,. He called his wife to check on me and she and friend were able to get me back in bed. Had fever of 101.4 took ibhone for headache and drank water to stay hydrated. Around 10 PM I was able to form sentences and communicate with family members. Next morning (2/25/2021) I got up around 8 AM and was fine. All symptoms were gone and arm was no longer sore.
70 2021-02-25 excessive sleepiness 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 2021-02-26 feeling abnormal Right after the injection my tongue felt fuzzy for while but it was gone the next day. I have a lar... Read more
Right after the injection my tongue felt fuzzy for while but it was gone the next day. I have a large black and blue which is now turning yellow. Today my where the injection was started itching and feels more and reddish. There are also reddish welts.
70 2021-02-26 feeling abnormal Day 2, red swollen feverish injection site size of a large lemon and a bad headache like I had when ... Read more
Day 2, red swollen feverish injection site size of a large lemon and a bad headache like I had when I had Covid. Fever 100. Same on 3rd day and towards evening my neck on left side felt weird. I woke up this morning with swollen lymph node on left neck and glands tender when I try to eat or drink.
70 2021-02-26 sleep disorder Received injection 3 PM Feb. 16. Mild Soreness Late Feb. 16. First night after injection could not s... Read more
Received injection 3 PM Feb. 16. Mild Soreness Late Feb. 16. First night after injection could not sleep on injection side due to tenderness in shoulder. More Soreness, Moderate Itching began Feb. 17. 10:00 AM Feb. 18 observed redness (had rubbed and scratched injection site). Kept moving and stretching arm - Soreness subsided and was gone by Feb. 22-23. Slight Itching has remained since Feb 18. Redness and warmth about 3" in diameter around injection site appeared Feb 18 and has remained. Still warm to touch, red blotchy appearance in 3" diameter zone around injection site as of Feb. 27. Redness, warmth, and itching is not preventing activities.
70 2021-02-27 feeling abnormal Moderna COVID -19 Vaccine EUA Fever, chills, ache all over, slight headache ? started at 18 hrs afte... Read more
Moderna COVID -19 Vaccine EUA Fever, chills, ache all over, slight headache ? started at 18 hrs after 2nd vaccine. This is Sunday February 28 at 12:00 noon. I don?t have a fever but I don?t feel good. I took Aleve yesterday (Saturday, 27) ,, then I took Tylenol. No relief . Took Tylenol this morning? still don?t feel great but no fever, no headache, no body aches.
70 2021-02-28 disorientation 2/14/21 experienced soreness at site of injection. 2/15/21 & 2/16/21 experienced flu-like symptoms (... Read more
2/14/21 experienced soreness at site of injection. 2/15/21 & 2/16/21 experienced flu-like symptoms (fever, extreme fatigue, muscle aches). 2/17/21 severe disorientation, feelings of dementia, nausea, difficulty walking, affecting L side, feelings of panic & agoraphobia, extreme fatigue, unable to complete any meaningful tasks. 2/18/21, 2/19,2/20,2/22 - continuation of symptoms on 2/17/21. 2/22/21 symptoms lessened but continued fatigue followed by 2/17/21 symptoms. These symptoms have continued intermittently until present day. (3/1/21)
70 2021-02-28 feeling abnormal 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 feeling abnormal pt stated the next day after receiving the 2nd dose of covid vax her temperature was 101.7, she felt... Read more
pt stated the next day after receiving the 2nd dose of covid vax her temperature was 101.7, she felt bad w/flu like symptoms, fatigued, head ache, stuffy nose and her arm was sore at the injection site. Pt states by the second day that all of her symptoms disappeared.
70 2021-02-28 excessive sleepiness, sensation of foreign body 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 sleep disorder Left arm so sore and muscle pain could barely move arm even when I tried on many occasions (started ... Read more
Left arm so sore and muscle pain could barely move arm even when I tried on many occasions (started 4:00 pm 2/26/2021) Tend to touch and could not put any pressure on the arm. Woke up several times while trying to sleep due to extreme sore arm. Also very tired. (7:30pm-7am). Arm still very sore, but able to exercise it (8am). Feeling very lethargic and cold while trying to complete a virtual class. ( 9am) Getting the chills and shakes even while wearing several warm layers of clothing, arm still very sore (9:30 am) Falling asleep while trying to participate in virtual class ( multiple times from 10:00am-12:30am). When session was over, I covered myself with 3 blankets and went to sleep after eating some lunch (1pm) Slept until 3:30, took temperature which was 101 degrees F, took a Tylenol, drank water, and fell back to sleep. Awoke about 6:30PM, checked temp which was lowered to 99.3F. at some dinner, drank plenty of water glasses. Slept all night from 8PM-9:40 am, Arm somewhat better, Still very tired, took another Tylenol with temp still at 99 and lots of aches. (My normal temp is in the low 97 degree area.) Went to bed still ill on Sunday. Better on Monday.
70 2021-03-01 incoherent Reactivated a head injury I sustained about 6 years ago. Symptoms: trouble walking; tiredness; hea... Read more
Reactivated a head injury I sustained about 6 years ago. Symptoms: trouble walking; tiredness; head pain; trouble communicating with words (slightly incoherent) etc. This began immediately following the injection & is still here these 3 1/2 weeks later. I reported this to Urgent Care & have been resting very much etc.
70 2021-03-01 insomnia Felt ?off? with mild h/a in evening of 2/24; around 2am, 2/25 started slight chills, h/a worsened, ... Read more
Felt ?off? with mild h/a in evening of 2/24; around 2am, 2/25 started slight chills, h/a worsened, body aches?did not feel feverish, but did not check. Could not sleep. R arm bruised & very sore-could not lay on it-applied ice. Finally at 4:30 AM took two Tylenol & slept until 11am. Very tired all day & took afternoon nap. Friday better-just tired & arm sore..
70 2021-03-01 sleep disorder Intense itching around the injection site on the left arm began in the afternoon on the third day af... Read more
Intense itching around the injection site on the left arm began in the afternoon on the third day after the shot. It would come and go throughout the afternoon and evening. I was only able to sleep about 5 hours and the itching woke me up and continued throughout the fourth day. I looked this up on the internet and found that massaging and exercising my arm help. The injection site had been sore the first three days, it was less swollen, sore and warm to the touch by the fifth day but there were three red patches around the injection site. All symptoms gone on the sixth day but a very mild itch is appearing occasionally today which is the seventh day. I also experienced itching after the first shot (Lot 042L20A) but it was very mild and went away by the fourth day.
70 2021-03-02 amnesia, confusional state, feeling abnormal Brain fog, confusion, dizziness, headaches, and loss of short-term memory, mental confusion, extreme... Read more
Brain fog, confusion, dizziness, headaches, and loss of short-term memory, mental confusion, extreme fatigue, muscle pain, Joint pain continuing 5 weeks after vaccination.
70 2021-03-02 mental status changes Mental state has changed since second dose. Alzheimer's symptoms have become very noticeably worse s... Read more
Mental state has changed since second dose. Alzheimer's symptoms have become very noticeably worse since second dose of Moderna Covid vaccine.
70 2021-03-02 sleep disorder, depression 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 2021-03-03 anxiety lightheadedness, anxious/headache, observation, water/juice offered, improved, sent home
70 2021-03-03 mental impairment, feeling abnormal Foggy brain for almost 48 hours. Couldn't think straight. Somewhat dizzy. Finally feeling better tod... Read more
Foggy brain for almost 48 hours. Couldn't think straight. Somewhat dizzy. Finally feeling better today, though I still get a little dizzy when I bend down or look down.
70 2021-03-04 disturbance in attention Total body muscular aching, chills, can't think straight; loss of appetite The flu like symptoms aba... Read more
Total body muscular aching, chills, can't think straight; loss of appetite The flu like symptoms abated 24 hours later; but still not thinking straight.
70 2021-03-04 feeling abnormal The day acter the cirst vaccine the left are was extremely sore, worse then any flu shot, lasted abo... Read more
The day acter the cirst vaccine the left are was extremely sore, worse then any flu shot, lasted about 3days. On February 14 woke up with My whole arm aching. About three days after that extreme pain in my upper arm. That did not go away with two versions of anti-inflammatory drugs. Was referred to an orthopedist for a possible shoulder injury. His diagnosis was cervical pinch nerve. He referred me to a neurologist. I am now on medication that has somewhat reduced the pain in my arm but it has not gone away completely. I had my second shot on March 3 and the next day the pain in my arm intensified I near the spot of the first injection. The second injection I took in my right arm. I am also experiencing today March by brain fog. My arm my right arm is sore much like a flu shot. Other than that I had no symptoms as mentioned in many publications after you get the second shot.
70 2021-03-04 sleep disorder Moderate pain days 1-3. Sudden onset pain above injection site day 7. Near shoulder. Painful enough... Read more
Moderate pain days 1-3. Sudden onset pain above injection site day 7. Near shoulder. Painful enough to wake me in night. Unable to sleep on that side. Gradual improvement by day 11.
70 2021-03-06 disturbance in attention, feeling abnormal Severe headaches for three days. Inability to concentrate, feeling off for 3 days. Nonspecific malai... Read more
Severe headaches for three days. Inability to concentrate, feeling off for 3 days. Nonspecific malaise.
70 2021-03-06 feeling abnormal Symptoms began approx 12 hrs after second injection. Body aches, brain fog, exhaustion. light nause... Read more
Symptoms began approx 12 hrs after second injection. Body aches, brain fog, exhaustion. light nausea, dizziness. No fever. Injection site was swollen, red, and hot to the touch. Initial symptoms lasted about 12 hours. Most of that time was spent sleeping. My arm was sore for about 4 days. No other reactions and there was no reaction to the first injection.
70 2021-03-06 feeling abnormal Chilled, nauseous, gastric distress, weak, no appetite, miserable, passed out 3 times
70 2021-03-07 confusional state 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 disturbance in attention THE DAY AFTER VACCINE AROUND 3:30 IN THE AFTERNOON ON FRIDAY I BECAME LETHARGIC, SITTING ON COUCH NO... Read more
THE DAY AFTER VACCINE AROUND 3:30 IN THE AFTERNOON ON FRIDAY I BECAME LETHARGIC, SITTING ON COUCH NOT RESONDING TO HUSBANDS QUESTIONS. SAT THERE FOR 5 HOURS, DON'T REMEMBER GOING TO BED BUT AWOKE EARLY MORNING HOURS AND REALIZED I SLEPT IN MY CLOTHES. I DID NOT TAKE NIGHT MEDS. SATURDAY I WAS ALERTK BUT STILL HAVING DIFFICULTY PROCESSING THINGS. I COULD HEAR A MOTOR RUNNING OUTSIDE AND I WAS CONVINCED MY NEIGHBOR WAS PUTTING IN A WELL. HE WAS ACTUALLY POWER WAHING HIS PORCH. IT WAS LIKE A DREAM. I FORCED MORE LIQUID INTAKE BUT APPETITE WAS POOR. SUNDAY I WAS IMPROVING. MONDAY ONLY SYMPTOM IS SORENESS AT INJECTION SITE.
70 2021-03-07 sleep disorder Sore arm the first few days with swollen lymph glands making it difficult to raise above my head, bu... Read more
Sore arm the first few days with swollen lymph glands making it difficult to raise above my head, but that subsided. On day 5, my left arm began itching (to the point of awakening me from a night's sleep) and by day 7, a red swollen hot and itchy area about the size of an orange appeared and the skin was very dry and coarse to the touch. The itching continued for days with the red area increasing in size to encompass about three-fourths of my upper arm. While the area increased in size, the itching and swelling decreased and by day 15, it was all gone, (I took pictures of it on 2/21 and 2/25 to document.)
70 2021-03-07 sleep disorder My muscles hurt all over especially in my lower back and mid back. No nausea. I didn't sleep well ... Read more
My muscles hurt all over especially in my lower back and mid back. No nausea. I didn't sleep well that night of, but I don't usually sleep well. About 4:30 AM is when is seemed to start aching. Very tired. Temp 99.7. Barely moved all day. Started feeling better around 6:00 onSaturday. (Had vaccination on Friday 10:30 AM. My back hurt for a couple more days and very tired. I did not report any of this cause they had told me I may have flu symptoms and I did.
70 2021-03-07 thinking abnormal Woke up next day, March 4, 2021, with nausea, weakness, and unclear mind. Lasted 1 day.
70 2021-03-08 anxiety Approximately 20 minutes after receiving the 2nd covid vaccine pt reported feeling lightheaded and d... Read more
Approximately 20 minutes after receiving the 2nd covid vaccine pt reported feeling lightheaded and dizzy which progressed to flushed blotchy redness on chest and neck. BP 190/104. Approx 3 minutes later pt reported feeling like throat was swelling and was having difficulty swallowing. Pt had premedicated with Benadryl 25mg po prior to arrival due to history on anaphylaxis to multiple other medications and foods. Benadryl 25mg po was administered and pt assisted to exam room. Pt began to be anxious and said swelling was getting worse. Epinephrine (1mg/ml) 0.5mg IM administered per standing order.Refused ambulance or transfer to ER at this time. Husband at side and said this has happened previously and she knows how to manage without the ER. 10 minutes after 1st dose of epinephrine a second dose of 0.5mg epinephrine administered due to continued swelling. PT was monitored in clinic. Left ambulatory with no resp distress or resp symptoms noted. Pt and husband refused EMS and ER. Instructed to follow-up with PCP and s/s to seek further treatment from ER.
70 2021-03-08 feeling abnormal 2nd dose shot was given at 10:50am on Sat. 3/6/21 , that evening my left arm started hurting, during... Read more
2nd dose shot was given at 10:50am on Sat. 3/6/21 , that evening my left arm started hurting, during the night it woke me up with throbbing pain. Next day Sunday, my arm was really sore. I had chills off and on all day plus a fever of almost 100 at times. Felt a little strange, hard to explain. No energy, just the blobs. Spent a few hours in bed during the day which was Sunday. The next day Monday, I felt much better. Today 3/9/21 I am back to normal. I was not too worried because I had heard a lot of people had issues with the 2nd dose. First dose, no problems except a sore arm for a day or two.
70 2021-03-08 mental impairment 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 2021-03-08 sleep disorder 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 2021-03-09 feeling abnormal 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 insomnia Moderna COVID-19 Vaccine. Site of vaccine is still very red, with a rash, and slightly swollen in th... Read more
Moderna COVID-19 Vaccine. Site of vaccine is still very red, with a rash, and slightly swollen in the area of vaccination, down just past her elbow. Patient also describes intermittent headaches, nightly insomnia, chills, and a cold feeling daily since her vaccination in February.
70 2021-03-09 sleep disorder Severe body aches in neck, shoulders and back-unable to sleep because of the pain Unable to regulate... Read more
Severe body aches in neck, shoulders and back-unable to sleep because of the pain Unable to regulate body temperature/felt very cold Malaise General feeling of being quite unwell
70 2021-03-10 excessive sleepiness Started out with chills and slight headache about 10 hours after vaccine. Chills went away after ab... Read more
Started out with chills and slight headache about 10 hours after vaccine. Chills went away after about 5 hours. Later in the night started experiencing nausea and temp of 101 . Continued all next day and couldn't stay awake over 10 minutes. Slept pretty much 24+ hours and did not get out of bed or eat. Again nausea through the night and a little headache. 24 hours after vaccine felt a little tired but was able to get up and eat. Now my arm is swollen and has rash.
70 2021-03-10 mental impairment Evening of the 2nd dose started having severe headaches. Continued having severe headaches, fever, ... Read more
Evening of the 2nd dose started having severe headaches. Continued having severe headaches, fever, sharp internal pains moving from one organ to another throughout the night. Next day severe headaches, fever, internal pains, lethargy. Difficulty thinking.
70 2021-03-10 poor quality sleep Sore stiff neck, headache started 8 hours after injection. Restless sleep. 6 am muscle aches arms, n... Read more
Sore stiff neck, headache started 8 hours after injection. Restless sleep. 6 am muscle aches arms, neck, back, hips. Chills and fever thru out the day reaching up to 101. Took ibuprofen alternating with acetaminophen. Went to bed at 8pm, slept good. Woke up at 6:30 slight headache. Most of the aches gone. No fever. Had vaccine at 11:15am. 2nd vaccine
70 2021-03-11 insomnia The pain started at 9:00 pm, a 4 on a pain scale of 1-10. By 1:00 am I could not sleep at all; the d... Read more
The pain started at 9:00 pm, a 4 on a pain scale of 1-10. By 1:00 am I could not sleep at all; the discomfort had shot to an 8 with a radius of pain around the injection site and arrows of pain that shot down my arm to my wrist and up to my neck. I had lost most of the movement in my right arm. Raising my arm no more than 10 degrees triggered intense pain. I research Covid vaccines and learned that the shot should be administered with the needle going into the arm at a 90 degree angle. My vaccine was administered at almost the top edge of my shoulder! I waited until 8:00 am to take 400 mg of Advil to keep it from inhibiting antibodies. I took more every six hours until this morning when my pain toggled between an 8 and a 9, and it was clear that the Advil wasn't working.
70 2021-03-11 sleep disorder 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 2021-03-14 feeling abnormal I woke up around 1:30 am on March 13th with feeling very achy and warm. I took my temperature and it... Read more
I woke up around 1:30 am on March 13th with feeling very achy and warm. I took my temperature and it was 101. I took some tylenol and went back to bed and fell asleep waking up again around 3:30 and feeling worse and took my temp again and it was still 101 had not gone down. Too someone tylenol and went back to bed and slept for a few hours and woke up feeling the same and my temp was the same, around 7:00am. I stayed in bed all day not eating much and drinking a lot of fluids. I kept on taking the tylenol to help to keep down the fever, but it still remained high at 101. I slept off and on during the day. The next day March 14th I woke up around 6:30 am and felt a little better and took my temp and it was down to 99.4. I still was kind of tired and my temp remained at 99. most of the day until I took my temp at 5:30pm and it was normal at 97.4. Another thing I experienced was a lack of taste. On March 15 I feel back to normal, except for the lack of taste,.
70 2021-03-14 insomnia Insomnia 03/12/21 12:00am-7:00am fatigue, headache 03/12/21 7:00am-3:00pm
70 2021-03-14 insomnia Moderna COVID-19 Vaccine EUA 029A21A 3/6 upon bed Injection site hurt so bad I could not sleep on l... Read more
Moderna COVID-19 Vaccine EUA 029A21A 3/6 upon bed Injection site hurt so bad I could not sleep on left arm, rolled over to sleep on right side and that was so painful I had to get up and sleep in a recliner to find a comfortable spot for right arm. My muscles in neck, lower back and calves also hurt. At 5:30 am the worst pain in right arm left and I went to bed. Slept until noon. Temp 101.8 took ibuprofen. Injection site swollen, painful, face slightly puffy. Day 2 - Site still swollen & painful. Entire top of left arm swollen. Temp 101.4 took Tylenol. Right arm not as painful, mostly gone, muscles still sore. Constipated. Fatigued. Slept off and on. Day 3 - Temp still 101 but did go down to 99. Still sore and injection site is still hot to touch and swollen. Fatigued. Day 4 - Fever broke at 6 am. 98.8. Injection site still very sore. Finally was able to go to the bathroom. Fatigued. Day 5 - Day 8 Injection site still sore and arm just feels funny. Fatigued and low energy. Day 9 arm feels pretty good today and Day 10 arm is feeling ok. I am still fatigued and feel like I need to sleep and rest a lot. I used Tylenol and Ibuprofen. I noticed just after getting my injection I seemed to have a lot more mucous than is normal. That seems a bit better now.
70 2021-03-14 insomnia Painful arm and warm to touch at injection site the day of injection, March 5, that continued throu... Read more
Painful arm and warm to touch at injection site the day of injection, March 5, that continued through March 15 Extreme joint pain on March 10 & 11, mild joint pain through March 15 Headache on March 10 continued through March 14 Sleepless nights began on March 10, lasting through March 15
70 2021-03-16 amnesia 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 2021-03-18 feeling abnormal felt "weird" about 15 min after, began having diaphoresis and tremors. Given 25 Benadryl po nand 20 ... Read more
felt "weird" about 15 min after, began having diaphoresis and tremors. Given 25 Benadryl po nand 20 mg famotidine po, BP 190/80 other vitals remained wnl, about 15 min after PO meds began feeling s/s subside and over next hour BP decreased to 160's/70's. Monitored and all s/s resolved
70 2021-03-18 feeling abnormal 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 insomnia 12 hours post shot shaking shivers cold lasting about 3 hours. Insomnia. 14 hours post shot..On scal... Read more
12 hours post shot shaking shivers cold lasting about 3 hours. Insomnia. 14 hours post shot..On scale of 1-10 headache at 8 in pain lasting about 8 hours then down to dull for additional hours into 3/19. Red area about palm size around shot with hardness and pain.
70 2021-03-18 sleep disorder Had the expected headache and tiredness that continued intermittently from first shot. Just a couple... Read more
Had the expected headache and tiredness that continued intermittently from first shot. Just a couple of days prior to second shot, upper teeth pain and some reaction to local high pollen count. Three days post second shot PCP started a course of antibiotics and decongestants thinking it was sinus related. Also had a couple of weeks of night sweats, headache and cheek pain strong enough to prevent sleep and cause difficulty eating. Pain became excessively strong about Mar 8. PCP ordered lab and sinus CT on Mar 11. Neither of which were significant. Night of Mar 12 had significant visual difficulties. March 13 morning the left temporal artery was tender and nodular with pain above left eye and left temple. March 13 suspicion of Giant cell Arteritis and administration of high dose steroids begun in afternoon.
70 2021-03-19 disorientation, amnesia First shot given 2/7/2021; no side effects out side of a sore arm. Second shot given 3/7/2021; withi... Read more
First shot given 2/7/2021; no side effects out side of a sore arm. Second shot given 3/7/2021; within 24hrs developed advanced memory loss, cognition, conceptualization, relativistic reasoning, spatial disorientation, and recognition issues with family member/s primarily in the evening. The symptoms of NPH, but amplified, now with Alzheimer (DAT) like symptoms accompanying it previously not significantly present. She's lived in this house with us for 33 years (doesn't know where we are and it is no longer familiar to her) and has been married to my father who she failed to recognize in the evening on multiple occasions since.
70 2021-03-19 feeling abnormal, sleep disorder Slight chills night 10pm. and still continuing 10 days later; heat waves 2 to 4 am. at night which d... Read more
Slight chills night 10pm. and still continuing 10 days later; heat waves 2 to 4 am. at night which disturbs sleep pattern-- put cool cloth on forehead helps and taking off layers of clothes which continued for 8 days. I did test temperature, but read 98 which is normal for me up to 98.3.; I did not have a headache but could definitely feel extra pressure; my body aches were about even all over body, not stronger at shot site probably because I relaxed before shot and stayed resting in my car for 30 minutes before driving away; I did not have swelling or any redness at the vaccination site; I have had a dry mouth which wakes me up a night even thought I have taken Biotine . It usually lasts the whole night. I did drink extra water during day as well as at night. I have had nausea but did not vomit for about 8 days. I lack energy and am still experiencing fatigue. I continue to swim laps and areobics at least one hour every day.
70 2021-03-20 insomnia 19 hours later. Unable to sleep. Chills, fever of 100.5 on and off through the day. Headaches, fatig... Read more
19 hours later. Unable to sleep. Chills, fever of 100.5 on and off through the day. Headaches, fatigue, neck achy. Arm swelling with pain and warm to the touch/.
70 2021-03-21 disturbance in attention Extreme headache. Extreme joint pain. Extreme fatigue. Chills. Sweats. Inability to concentrate. Hea... Read more
Extreme headache. Extreme joint pain. Extreme fatigue. Chills. Sweats. Inability to concentrate. Headache and joint pain lasted 3 days. On and off chills and sweats for 5 days. Fatigue and inability to concentrate continuing today (8 days)
70 2021-03-22 nervousness Until 03/20/2021 I had fever, chills, nausea, cramps, fatigue, body aches, sore arm, and felt shaky;... Read more
Until 03/20/2021 I had fever, chills, nausea, cramps, fatigue, body aches, sore arm, and felt shaky; until 03/23/2021 I had all the previous except fever, chills and sore arm.
70 2021-03-22 sleep disorder On 3/2/21 Patient recieved her first dose of the COVID-19 Moderna Vaccination. She reported 4 days l... Read more
On 3/2/21 Patient recieved her first dose of the COVID-19 Moderna Vaccination. She reported 4 days later that she started itching very badly over entire body. She tried taking anti-histamines with the reccomendation of her physician Dr. She tried Benadryl, followed by Zyrec, and Allegra, and Pepcid with no relief for a couple of days. The itching was so bad she could not sleep and affecting her also during the day. She had another appointment over video with Dr. again. Dr. prescribed on 3/12 a prednisone taper to take if needed. She advised to try to wait 14 days if she could to make sure the vaccine would be effective. She was still itching on 3/16 and started the Prednisone taper. She called this morning and she is still itching at the end of the taper on 3/23. The prednisone provided some temporary relief but now that the taper is almost done the itching is returning very severely. She reports itching on hands, feet, ankles, armpits, back, head, and scratching with some bleeding.
70 2021-03-23 disorientation Feeling like I was drugged. Whoozy, not able to think right, body feeling like was going to collaps... Read more
Feeling like I was drugged. Whoozy, not able to think right, body feeling like was going to collapse. Slowed speech
70 2021-03-23 impaired work ability Fever, chills, bone and joint aches, painful arm from injection site, debilitating headache. I took... Read more
Fever, chills, bone and joint aches, painful arm from injection site, debilitating headache. I took 2 Advil every 6 hours over a 24 hour time period. After sleeping for over 30 hours, I was able to eat and return to work. I missed a full day of work.
70 2021-03-24 loss of personal independence in daily activities Received 1st shot on March 2 noticed only slight discomfort of Right arm. Then 2 weeks later on Ma... Read more
Received 1st shot on March 2 noticed only slight discomfort of Right arm. Then 2 weeks later on March 16 I had difficulty moving my arms above my head . Pain in my legs getting up from chair, going up stairs. Progress to difficulty with getting in and out of bed, turning in bed, showering and dressing. I had pain in both arms, hands and legs at rest. Pain and stiffness of the neck. Starting taking Advil and Tylenol with little relief. Talk with NP at Dr. office Told to rest, fluids and heat. Folowed up with office visit on March 29 and Lab work, Started on Prednisone 10mg qd March 24th.. Today March 25 I have noticed some improvement.Ck 565
70 2021-03-25 feeling abnormal, amnesia, confusional state About 3 1/2 hours after my vaccine I began taking a walk with my husband ( no issues at all) when... Read more
About 3 1/2 hours after my vaccine I began taking a walk with my husband ( no issues at all) when I very suddenly began dragging my feet , holding my right arm very stiffly, and showing significant signs of confusion. He assisted me in getting back into our home, gave me baby aspirin, asked me questions as to his middle name, of which I just starred back at him. I can remember him asking me questions, and I was wondering why my brain was not responding. My gait had already returned to normal as I could take the steps into our home with no problem. My brain fog lasted approx 30-35 minutes. He did bring me to our local ER , where tests were negative but I did stay overnight.
70 2021-03-25 memory impairment, confusional state 3-25-21 TC FROM PT - STATES AFTER COVID SHOT #1 SHE HAD A FEVER AND BECAME CONFUSED ON THE NEXT DAY.... Read more
3-25-21 TC FROM PT - STATES AFTER COVID SHOT #1 SHE HAD A FEVER AND BECAME CONFUSED ON THE NEXT DAY. STATES SHE FELL IN HER BATHROOM AND LAYED FOR HOURS ON THE FLOOR BEFORE HER FAMILY FOUND HER. SHE WAS TAKEN TO ER AND KEPT FOR 3 DAYS (MRI & XRAYS WERE OK). SHE THEN SPENT 4 DAYS @ LTCF. AFTER COVID SHOT #2 SHE BECAME CONFUSED AGAIN/COULDN'T REMEMBER ANYTHING AND HAD TO STAAY WITH HER FAMILY X 1 WEEK. SHE STATES SHE IS BETTER NOW AND HAS MADE A FULL RECOVERY.
70 2021-03-25 restlessness . Client c/o incidence of dizziness, being cold and was provided cover and a heater. 12:00 pm B/P 14... Read more
. Client c/o incidence of dizziness, being cold and was provided cover and a heater. 12:00 pm B/P 142/87, 80, 26, moving her left shoulder around, talking rapidly . At 12:10 pm client became restless, face became flushed, c/o numbness in her face and fingertips with increased respirations. 12:11 pm Dr. was contacted via phone by RN and Benadryl 50 mg IM in RD was administered by RN. 12:13 V/S 136/79,65,24 client was reclined, decreased flushing, slowed resp and decreased SOB. 12:16 pm DON was contacted and notified of incident.12:21 pm Dr. was called by RN.911 was active at that time.02 via facial mask @ 2 liters was applied. No redness or swelling to injection site noted. Client raised to upright position. V/S 141/82, 73, 26. 12:33 EMS arrived on scene. B/P 143/91, 72, 24.EMS was provided history and V/S. Client?s respirations and SOB decreasing, still flushed. Client refused transport. EMS departed at 12:45. Client called friend to come pick her up. She continued to be flushed and shaky. V/S at 1:06 pm were 148/96, 72, 22. Respirations were unlabored, client remained somewhat flushed. Friend is to monitor her. Client was transported to friend?s car via W/C for safety.
70 2021-03-26 loss of personal independence in daily activities Head ache, neck ache, eyes ache, lymph nodes hurt. Dizzy, tired, chills, extreme shivering. Unabl... Read more
Head ache, neck ache, eyes ache, lymph nodes hurt. Dizzy, tired, chills, extreme shivering. Unable to prepare meal. Always dress first thing every morning. Today was not able to get dressed until after noon.
70 2021-03-26 sleep disorder First symptom was tightening of throat on 2/18/2021 not closing nor sore just tightening. That las... Read more
First symptom was tightening of throat on 2/18/2021 not closing nor sore just tightening. That lasted 48 hours. Joint pain started after throat dissipated on Friday 2/19/21. Joint pain was progressive from shoulders for several days, then knees for a day, then tops of one foot for one night, then it moved to my hands. I had swelling where I could not close my hands. I had severe and exstremely painful joint pain in both hands that kept me up at night and unable to pick up things or close my hands. I used ice packs for some relief. It would sometimes calm down somewhat for hours and I would think it was over and then it would come back . The hand symptoms lasted from 2/23/21 through 3/5/21 when pain began to slowly calm down. I had one hand that would not close into a fist for one day 3/6/21 when pain was much less. By Sunday 3/7/21 most symtoms were much less with symptoms dissipating all together. I have had no recurrence since the weekend of 3/6/21 of any symptoms.
70 2021-03-26 sleep disorder 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 excessive sleepiness 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 feeling abnormal Got the vaccine, no problems with the arm, then about 3 hours later after had something to eat, and ... Read more
Got the vaccine, no problems with the arm, then about 3 hours later after had something to eat, and had a headache and took a nap. She woke up and sneezed and her nose then started running and wouldn't stop. She just felt that she was in lala land, fatigued, chills, scared her. This continued for about 5 days. She took some Benadryl, and also took some arthritis Tylenol. Her feet are bothering her badly where they weren't that bad before, feel like sponges. She has not notified her doctor. Feels like it attacked her neuropathy.
70 2021-03-28 hallucination Halluciation I went to ER no treatment given.
70 2021-03-29 impaired work ability I had slight itching after injection while waiting the 15 minutes in the store after injection. I s... Read more
I had slight itching after injection while waiting the 15 minutes in the store after injection. I started next day feeling slight sore throat, then under-the-weather, so unable to work at computer.. fever in evening 99.6. Took 1 tylenol 500. and went to bed ca 7 p.m. Slept fitfully, joints hurting: back, neck, ribs, knees, hands. No sweating. Slight persistent headache. Feeling of discomfort in bowels all night (constipation not diarrhea). Injection site hurts to touch. 30 March 2021, today: slight sore throat, headache, right arm injection site --3" redness and swelling around site. still slight sore throat. No temperature (97.5). Feel
70 2021-03-30 feeling abnormal, sleep disorder 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 feeling abnormal Patient complained of dizziness describes as "not feeling right like I could feel something in my bo... Read more
Patient complained of dizziness describes as "not feeling right like I could feel something in my body that's not supposed to be there." PT was assisted to private area and after resting she reported that all symptoms have subsided. Total contact was approximately 10 minutes.
70 2021-03-30 feeling abnormal 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 mental status changes fever , altered mental status , local injection site pain and erythema about 2 days after vaccine. ... Read more
fever , altered mental status , local injection site pain and erythema about 2 days after vaccine. resolved symptoms in about 2 days
70 2021-03-31 agitation 3 days after 2nd vaccine had severe itch all over my body excluding genital area and scalp. I was fr... Read more
3 days after 2nd vaccine had severe itch all over my body excluding genital area and scalp. I was frantic, agitated, and jittery. Used Benadryl 25-50 mg at a time, a variety of itch lotions and itch powder, and baking soda bath to little relief. Spoke with MD who prescribed Zyrtec, Pepcid, Prednisone (5 days), and hydrocortisone cream 1%. Temporary relief. The itch resumed after Prednisone and I visited 2nd MD who prescribed Prednisone in a different dosage, Atarax which treated the jitters and agitation. I continued with the hydrocortisone as it gave good relief. Duration: 17 days. No hives, no rash just blood bruising on both arms and skin abrasions from the scratching. This was my second dose of Moderna. No problems with the first. I will not take it again.
70 2021-03-31 feeling abnormal pt states that she woke up with severe cramps in both legs. she could not walk because of the pain.... Read more
pt states that she woke up with severe cramps in both legs. she could not walk because of the pain. she applied heated blankets. she had extreme fatigue, loss of appetite, nauseated, slight fever, and feeling bad all over. These symptoms lasted a couple of days. She still has some hypersensitivity on the right side of her the forehead. she cant see anything but can feel it.
70 2021-03-31 insomnia Hearing my heartbeat in my right ear practically daily. Sometimes louder than at other times. On... Read more
Hearing my heartbeat in my right ear practically daily. Sometimes louder than at other times. One day so loud & constant, it was difficult to sleep.!
70 2021-03-31 sleep disorder 3:30 am woke with massive headache, lot of body aches, no urination for hrs, unable to sleep due to ... Read more
3:30 am woke with massive headache, lot of body aches, no urination for hrs, unable to sleep due to all over pain. Arm extremely sore; took fluids and then had some nausea. This went on for 2 days. Still very tired, arm still sore.. Used Tylenol for pain. helps just a little bit. Did not seek any treatment.
70 2021-04-01 anxiety 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 2021-04-01 fear Blinding headaches, throwing up, chills, fever, dizziness.
70 2021-04-01 excessive sleepiness, delirium very Frantic; episode of psychosis; Delusional; Dizzy; Headache; malaise; big knot there [injection ... Read more
very Frantic; episode of psychosis; Delusional; Dizzy; Headache; malaise; big knot there [injection arm]; itched; Could not stand up staright; had 17 or 18 falls in 2 days; slept so much after the vaccination; A spontaneous report was received from a pharmacist concerning a 70-year-old age female patient who received mRNA-1273 vaccine and experienced very frantic/delirium, episode of psychosis/psychotic disorder, Delusions/delusional perception, dizziness, Headache, malaise, knot on injection arm/vaccination site mass, itch/pruritis, could not stand up straight/dysstasia, 17 or 18 falls for 2 days, slept so much/Hypersomnia. The medical history was anaphylactic reaction like iodine. Concomitant medications were not provided by the reporter. On 17 Mar 2021, prior to the onset of events, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: 045A21A) via Intramuscular route in the right deltoid for prophylaxis of COVID-19 infection. After the first dose of vaccination, on an unspecified date, the experienced delusional, dizzy, and go through an episode of psychosis and was very frantic and got better and patient never had this before, had headaches and malaise, slept so much, had a big knot in her arm, itched, hard, could not stand up straight, 17 or 18 falls in 2 days. The event delirium worried about was medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event frantic was resolved. The outcome of the events episode of psychosis, delusions, dizziness, headache, malaise, knot on injection arm, itch, could not stand up straight, 17 or 18 falls for 2 days, slept so much were 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 the events, a causal relationship cannot be excluded.
70 2021-04-02 feeling abnormal, sleep disorder 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 insomnia, anxiety Audible Hallucinations / Delusions Insomnia Anxiety Fluctuating Blood pressure Urinary Tract Infec... Read more
Audible Hallucinations / Delusions Insomnia Anxiety Fluctuating Blood pressure Urinary Tract Infection
70 2021-04-04 confusional state My arm was very swollen. After some hours my joints began to ack and over night became very painful.... Read more
My arm was very swollen. After some hours my joints began to ack and over night became very painful. All day the next day and through part of the next day I was so cold, I could not get warm and my whole body shivered violently. My arm at the injection site was very painful, I could not touch it. That lasted for five days. I was very weak and am still pretty weak. Through it all, I was confused(my mind didn't seem to be working well). I had a rash on my left leg for 3 days. I don't see how this could possibly relate, but thought I should mention it. I did not see a doctor or go to a medical facility.
70 2021-04-04 feeling abnormal, impaired work ability 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 sleep disorder Within 12 hours -- extreme pain in fingernails and toenails; after 18 hours, overall fatigue, extrem... Read more
Within 12 hours -- extreme pain in fingernails and toenails; after 18 hours, overall fatigue, extreme muscle pain, low grade fever of 100 degrees. Need to sleep Lasted only that one day. Two weeks later, welts breaking out on left side of body - thought it was poison ivy, but appeared different. Next day had extreme diarrhea, vomiting for 12 hours. Extreme weakness. Then for one day I was okay other than weakness; 2nd day diarrhea and vomiting returned with extreme weakness. After about 8 hours, the previous welts spread to all heat spots on my body, both sides, lymph nodes appeared to swell underarm. Itching over entire body to such an extent it was "driving me crazy" -- I took 2 Benadryl with no impact; then took 2 Prednisone 5 mg, then forced myself to ignore itching while sitting in my recliner the rest of the night. Fell asleep about 2 hours later. When I awoke after 4 hours, the itching and welts were gone. Within another 6 hours I was able to eat regular diet with no nausea or other side effects. At first, I thought this was diverticulitis because I had eaten popcorn -- but the worst diverticulitis has ever done to me is mild diarrhea and occasional nausea. Never any of these other issues.
70 2021-04-04 sleep disorder Sudden dizziness, extreme body aches lasting for four days, temperature 103 for four days, chills, h... Read more
Sudden dizziness, extreme body aches lasting for four days, temperature 103 for four days, chills, hot flashes, unable to take food for four days due to sore throat, tastelessness, severe thirst, severe headache. Took aspirin and Ubrelvy with no relief first three days, minimal relief next day. Headache lasted four days. Unstable on feet, stumbling, extremely dizzy for four days, sleepy, but unable to stay asleep. On Fifth day (Monday after Wednesday injection), still not steady enough to drive but able to eat spicy food (can taste something) and can walk around slowly. Called Doctor for advice and told to report to CDC. Don't think second dose is good advice? When received Hepatitis vaccination series as police officer, had anaphylactic reaction, received epinephrine.
70 2021-04-05 abnormal dreams, sleep disorder Very weird vivid dreams that wake me in the middle of the night after about two or three hours of sl... Read more
Very weird vivid dreams that wake me in the middle of the night after about two or three hours of sleep. They are non sensical dreams but vivid and disturbing enough that I am unable to go back to sleep. It?s been occurring almost every night or every other night since the second vaccine.
70 2021-04-05 confusional state, disorientation She had the vaccine in the evening, laster that night had chills and headache, then went on to devel... Read more
She had the vaccine in the evening, laster that night had chills and headache, then went on to develop acute confusion and disorientation. Admitted to the hospital with acute metabolic encephalopathy of uncertain etiology. resolved by the next day
70 2021-04-05 confusional state 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 2021-04-05 feeling abnormal, confusional state My initial symptoms described below started within hours (sore arm and swollen lymph) and continued ... Read more
My initial symptoms described below started within hours (sore arm and swollen lymph) and continued 7-10. Joint, muscle aches; diarrhea, extreme fatigue, headache, sharp pain in head, brain fog/confusion, flu like symptoms, chills. Today experiencing many of those same symptoms and unknown if it?s related. I?ve had good days in this last month as well. I postponed 2nd shot. Herpes outbreak as well which I have Very seldom. Immune system definitely fighting hard!
70 2021-04-05 sleep disorder, fear, thinking abnormal On second night following the second dose, I experienced racing thoughts and images (not hallucinati... Read more
On second night following the second dose, I experienced racing thoughts and images (not hallucinations) while awakened from sleep. I could not control the thoughts and it felt like what I imagine a bad recreational drug experience would be like. It was frightening because I never experienced anything like it. It was as if my mind was trying to solve visual word and number problems in flashes. I was drowsy but not asleep. I was sweating but did not have a fever. I had some nausea but did not vomit. Over the course of the night, it gradually resolved and felt like a "fever" had broken, even though it was not a fever. I wanted to report it because I have not heard of such cognitive symptoms and there is no other explanation I know of. Prior to this episode after the second shot, I had a variety of minor headaches, body aches, and chills but nothing significant. I had no symptoms after the first shot. I woke up exhausted the following day and am still tired but almost back to normal (third 24 hour period after shot). Thank you for your consideration.
70 2021-04-06 emotional distress 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 2021-04-06 excessive sleepiness Body aches, fever 101.6, headache, tiredness. Body aches lasted only about 6 hours. Fever was off a... Read more
Body aches, fever 101.6, headache, tiredness. Body aches lasted only about 6 hours. Fever was off and on for about a week. Tiredness : I slept for over 24 hours starting about 8 hours after injection and was tired for 10 days. Dry mouth and loss of taste lasting 3 weeks or more. Rash at injection site and under arm started at day 10 and is there but more redness than rash now. It took atleast 10-14 days to feel normal again.
70 2021-04-07 feeling abnormal 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 irritability Constant runny nose in beginning, dizzy, stomach ache, achey joints muscles, irritability, feeling w... Read more
Constant runny nose in beginning, dizzy, stomach ache, achey joints muscles, irritability, feeling water swooshing ears, feelings of cold sensation on inner thigh, some headache
70 2021-04-09 depression, anxiety anxiety & depression the night of the vaccination until next day
70 2021-04-09 loss of personal independence in daily activities She reported that the side effects started around noon on the day that she received the vaccine (her... Read more
She reported that the side effects started around noon on the day that she received the vaccine (her appointment was at 10 AM on Tuesday April 6th). Patient reported lots of stomach and trunk pain (she was unable to walk straight up and had to leave work early) but she did not report any nausea, vomiting, diarrhea or constipation. Patient reported a fever at a maximum 103.6F at 2:30 PM Wednesday April 7th but it ranged from 99.9F to 101F otherwise. She reported taking Tylenol throughout the day and hydrating but she said that she didn't eat Tuesday into Wednesday because she lost her appetite and was in pain. She said the trunk pain was causing her difficulty in breathing. By 7:00 PM Wednesday, all of her symptoms were resolved and she felt fine.
70 2021-04-11 feeling abnormal This is my second time submitting this form. I experienced fever and chills the day after my 2nd va... Read more
This is my second time submitting this form. I experienced fever and chills the day after my 2nd vaccine.( February 15) This lasted 2 days. The fever never left. I have had a low grade fever(99 - 100) since , along with fatigue and brain fog. My normal body temperature is 96.5 - 97.5. The brain fog is so bad I cannot drive or work. I've been seeing 2 doctors with no results. I know of 2 other friends that have the same symptoms with no relief for weeks.
70 2021-04-12 anxiety Ringing in ears very loud anxiety and dizziness
70 2021-04-12 feeling abnormal started with adverse reaction of chills, headache, severe joint pain, nausea 2 days post vaccination... Read more
started with adverse reaction of chills, headache, severe joint pain, nausea 2 days post vaccination. She reported to us after 2 weeks of her symptoms as she was still experiencing migraines unlike her normal issues and she was experiencing nausea suddenly at different times of day and still did not feel normal post vaccination. I did follow up with her after 2 and a 1/2 weeks and she said she did wake up feeling good and thinks the symptoms have resolved.
70 2021-04-13 depression Within 2 days, hives broken out on body that have continued to get worse. This is still persistent ... Read more
Within 2 days, hives broken out on body that have continued to get worse. This is still persistent till present time,, 2 months, 1 week later. I have seen primary doctor, my allergist regarding this. Obid has run multiple labs showing all mostly normal except for allergic reaction and large increase in cholesterol form last July. Cholesterol has run almost same (normal)my entire life and now at 249. I am now in 4 (24 hour tabs Allegra) QID, Pepcid 40 BID, Vanicream, Triamcinolone 0.5% cream, and Tylenol for pain. The hives continue to run rampant most days, calm a few days. They burn like an iron burn on your skin, itch madly, and swell. At times, there is so much fluid retention from them that I am totally miserable and depressed. I was also put on Doxepin (for itching side use but unable to tolerate due to blurred vision. Treatment is not in control of hives, but does help somewhat. I always have quite a lot and much extreme discomfort. Unknown if this will be permanent or how long it will last.
70 2021-04-14 memory impairment Upset stomach, headache, right fingers cramp, chest pressure, forgetful, rashes in face and itching... Read more
Upset stomach, headache, right fingers cramp, chest pressure, forgetful, rashes in face and itching arms and neck, flushing
70 2021-04-18 feeling abnormal Minutes after receiving vaccine I felt a tingling in my head, got a mild headache, brain fog. The ti... Read more
Minutes after receiving vaccine I felt a tingling in my head, got a mild headache, brain fog. The tingling continued down into my body. Shoulders, chest, abdomen at which time I was slightly nauseas, and then slowly on to my knees when I became weak. The effects went on for several hours. These episodes went on for approx. 7 weeks. Not daily. In fact I didn't have another episode for several weeks. But at one time I had 11 days in a row. They lasted up to 4 hours. And several times I felt as though I would collapse when the effects reached my knees. But on the last week of the episodes, I could tell they were getting milder.
70 2021-04-18 sleep disorder, memory impairment Moderna COVID 19 requirement Brought to ER for memory issues, mania like symptoms, lack of sleep, w... Read more
Moderna COVID 19 requirement Brought to ER for memory issues, mania like symptoms, lack of sleep, wandering, noncompliance with medications, paranoia Admitted to Geriatric Inpatient Psychiatric unit
70 2021-04-21 feeling abnormal Severe tinnitus on left side, severe headache, brain fog, fatigue.
70 2021-04-21 excessive sleepiness I received the vaccine at 12:30 on Wednesday (3-31-21) and I had chills and began running a temper... Read more
I received the vaccine at 12:30 on Wednesday (3-31-21) and I had chills and began running a temperature of 102.2-102.4 which continued until Sunday, 4/4/21 at noon. I also had a migraine headache causing nausea and was unable to eat until the morning of 4/4/21. I slept for the most part of two days and on the third day I was less sleepy but, still had all the other symptoms I mentioned as well as I ached in all my joints. As of (4/22/21) I am still unable to lay on my left side due to my left arm hurting when I do.
70 2021-04-21 insomnia 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 sleep disorder 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 2021-04-22 feeling abnormal Pt started to feel "funny" within 3 minutes of 2nd vaccination, had tingling in mouth. Pt took Bena... Read more
Pt started to feel "funny" within 3 minutes of 2nd vaccination, had tingling in mouth. Pt took Benadryl 25 mg at 11:04. At 11:15 gave 0.5 ml of epi due to developing cough and flushing. Pt started on 02@10L via nonrebreather by EMS. SP02 stayed between 98%-100% during duration of treatment at clinic, lungs clear. Sent to ER via ambulance.
70 2021-04-22 loss of personal independence in daily activities, confusional state Got the vaccine, that night about 11:30 she sat on the cough and got up and was shivering, shaking ... Read more
Got the vaccine, that night about 11:30 she sat on the cough and got up and was shivering, shaking and freezing to death, could not get warm. She could not get warm at all that night. On Tuesday she was real weak and felt that if she got up and got moving was sick as she could be the entire day. She went to bed around 4:00 PM and thought that she had passed out as she crashed. She then woke up and thought it was the next day and was confused. She just pretty much stayed in bed, and could not do anything. Wednesday, she called and told that the symptoms lasted a day or two, she had loss of appetite, weak, ringing in her ears, headache, nausea. Friday, Saturday and Sunday still with the same symptoms. Then on Monday 3/29/21 called her doctor who prescribed her something for the nausea and to continue taking the Tylenol. Tuesday 3/30/21 still same symptoms with the ringing in the ears. On Wednesday 3/31/21 she was able to eat some, and by the 4/1/21 she continued to be able to eat more. She is now feeling much better on 4/23/21 but the ringing in the ears has continued.
70 2021-04-26 feeling abnormal eyeball filled with blood; Blotchy red skin felt like sunburn; burning skin; felt like she weighed a... Read more
eyeball filled with blood; Blotchy red skin felt like sunburn; burning skin; felt like she weighed a thousand pounds; sore all over,; This spontaneous case was reported by a non-health professional and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (eyeball filled with blood) in a 70-year-old female patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Apr-2021, the patient received dose of mRNA-1273 (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced CONJUNCTIVAL HAEMORRHAGE (eyeball filled with blood) (seriousness criteria medically significant), ERYTHEMA (Blotchy red skin felt like sunburn), SKIN BURNING SENSATION (burning skin), FEELING ABNORMAL (felt like she weighed a thousand pounds) and MYALGIA (sore all over,). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (eyeball filled with blood), ERYTHEMA (Blotchy red skin felt like sunburn), SKIN BURNING SENSATION (burning skin), FEELING ABNORMAL (felt like she weighed a thousand pounds) and MYALGIA (sore all over,) outcome was unknown. The action taken with mRNA-1273 (Intramuscular) was unknown. 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.
70 2021-04-27 anxiety 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 2021-04-28 disorientation Stopped at store on my way home following vaccine. Approximately 1 hour elapsed following vaccine. I... Read more
Stopped at store on my way home following vaccine. Approximately 1 hour elapsed following vaccine. I left store and went to get into my car. Not only could I not locate car, parking lot appeared to be totally unfamiliar to me. I had to consciously scan the horizon to orient myself to my location. Entire episode lasted about 2 minutes. Scary 2 minutes. Once it passed, I was fine. I got in my car and drove home. This never happened to me before. Can only attribute to adverse event from vaccine. Please note I am 70 but I hold an almost full-time responsible position.
70 2021-04-28 insomnia Nothing serious, just odd. I am not one to get headaches, but have had recurring mild headaches, ti... Read more
Nothing serious, just odd. I am not one to get headaches, but have had recurring mild headaches, tinnitus, and the strangest event is that whatever I hear, especially music, will repeat in my head for hours. The best way to describe it is a busyness in my mind, which I did not have before. Nonstop, which causes insomnia.
70 2021-04-28 sleep disorder Arm became sore at 5:25 pm (03/31/2021) developed chills, could not sleep for shaking, headache and... Read more
Arm became sore at 5:25 pm (03/31/2021) developed chills, could not sleep for shaking, headache and joint pain (03:08 pm on 04/01/2021) ***this is what she texted to me and my other sister and the 03:08 pm text was the last text she had texted***
70 2021-05-03 feeling abnormal Severe swollen lymph nodes within hours of 2nd Moderna Vax on 3/17/21. Severe pain for over 5 days (... Read more
Severe swollen lymph nodes within hours of 2nd Moderna Vax on 3/17/21. Severe pain for over 5 days (nearly bed ridden). Lymph nodes are still slightly swollen as of 5/4/21 and SEVERE Fibromyalgia flare up/pain that has lasted longer than any previous flare up. I just want the overall body pain and "fibro fog" go away!
70 2021-05-07 amnesia, disorientation 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 amnesia 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 2021-05-08 disturbance in attention Day 1 - bad taste in mouth, fuzzy vision, bad headache, tiredness, equilibrium off, nausea, sorenes... Read more
Day 1 - bad taste in mouth, fuzzy vision, bad headache, tiredness, equilibrium off, nausea, soreness & pain down entire left arm Day 2 - left arm very sore, nausea, bad headache, fuzzy vision, feeling very sick Day 3 - very tired and body aching all over, dull headache Day 4 - extreme pressure in head, difficulty concentrating, pain in ears, loss of hearing in right ear until aprx 8:00 PM, overall feeling sick Day 5 - Hearing ok, tiredness and body aching with leg pain Days 6 thru 10 - body breaking out in sweats Treatment: Tylenol, Advil, rest Outcome: Felt better after Day 10
70 2021-05-09 sleep disorder I had a very stiff, sore arm with both shots. After the second I had vomiting, fever, loss of appeti... Read more
I had a very stiff, sore arm with both shots. After the second I had vomiting, fever, loss of appetite, severe fatigue - this lasted 4 days. The biggest issue is that my arm is still painful, so much so that I cannot lay or sleep on that side.
70 2021-05-11 feeling abnormal precipitated recurrent facial hives and chronic neurological symptoms (internal tremor, lack of coor... Read more
precipitated recurrent facial hives and chronic neurological symptoms (internal tremor, lack of coordination, headaches, fogginess)
70 2021-05-14 feeling abnormal 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 2021-05-16 loss of personal independence in daily activities, excessive sleepiness, feeling abnormal 5-13-21 8:00 pm severe pounding headache, extreme fatigue slept from 9:00 pm May 13 until 8:30 May 1... Read more
5-13-21 8:00 pm severe pounding headache, extreme fatigue slept from 9:00 pm May 13 until 8:30 May 15. Diahhria and vomiting during the night May 13. Saturday May 15 woke up with swollen lower lip, left side of my tongue 2 large sores, sore throat, pressure in my right ear, felt off balance hand unable to drive and foggy thinking.
70 2021-05-16 sleep disorder Approximately 3 weeks post vaccination, patient experienced intense pain going across the shoulders ... Read more
Approximately 3 weeks post vaccination, patient experienced intense pain going across the shoulders and up the neck. Describes as "bone pain". Had difficulty raising arms, this was painful. Lasted approximately 3 weeks. Pain woke her up in the middle of the night. Patient reports seeking medical attention from an orthopedist who performed x-rays but they were not remarkable for any disease/injury. Thought it was potentially rotator cuff related but it was on both sides and the x-rays did not show this.
70 2021-05-24 sleep disorder chills, burning in joints and muscles and nerves, couldn't sleep, intense pain, only on left side, c... Read more
chills, burning in joints and muscles and nerves, couldn't sleep, intense pain, only on left side, couldn't walk, fell 3 times, severe joint pain
70 2021-05-25 sleep disorder, loss of personal independence in daily activities I received 2nd shot on 2-23-2021. Went to bed but was woken up by severe migraine. Migraine went on ... Read more
I received 2nd shot on 2-23-2021. Went to bed but was woken up by severe migraine. Migraine went on for 4 days with my trying to combat it with the Tizanidine. Nothing stopped the pain. I have had severe and medium pa8n in my head, in my back right side 0f my head and right neck muscle since then. Nothing is stopping the pain and Ive been home bound in bed since then. I have Cervical Dystonia which causes severe migraines and I take the Tizanidine for that. It has handled my condition fine till 2-24-2021 at 2am. I finally got into the dr last week and she has ordered Diazapam to help sleep but it has no effect. Im now scheduled for 2 MRI's June 3rd 2021. Its also possible I should be Botox shots to my muscle to stop it from spasming and causing the migraines. Whatever was in the 2nd Moderna shot, has caused my neck muscle to spasm non stop and is effected my whole right side of my head, the top and front area.
70 2021-06-02 feeling abnormal Dizzy Shortness of breathe upper abdominal pain Rash across chest Felt weird The following day went ... Read more
Dizzy Shortness of breathe upper abdominal pain Rash across chest Felt weird The following day went to see cardiologist on 01/29/2021 EKG was done and came back noemal. Determined to be a reaction to the vaccine. Encouraged to get the second shot. 01/29/2021 I was feeling better after seeing the cardiologist.
70 2021-06-02 loss of personal independence in daily activities 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 insomnia, loss of personal independence in daily activities 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 2021-06-06 insomnia After 12 hours experienced severe chills, very low grade fever, sleeplessness, fatigue, lasted for a... Read more
After 12 hours experienced severe chills, very low grade fever, sleeplessness, fatigue, lasted for about 12 hours. Several weeks after the 2nd dose of Moderna vaccine, I have noticed a marked increase in my Tinnitis. comes and goes at al l hours of the day and sometime at night.
70 2021-06-06 loss of personal independence in daily activities Patient with persistent and chronic fatigue. She can no longer perform activities that she once did.... Read more
Patient with persistent and chronic fatigue. She can no longer perform activities that she once did. She takes an hour nap in the morning and 2 hour nap in the afternoon. She has no energy. She no longer goes for walks.
70 2021-06-07 sleep disorder, feeling abnormal 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 confusional state, agitation, disturbance in attention 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 personal independence in daily activities, feeling abnormal 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 altered state of consciousness In the days following the vaccine, patient developed decreasing responsiveness and presented to the ... Read more
In the days following the vaccine, patient developed decreasing responsiveness and presented to the hospital 4 days after vaccination with leukocytosis acute renal failure
70 2021-06-09 confusional state 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 confusional state 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 2021-06-15 nervousness I had a bad headache and started with a temp. Then I had some swelling that almost looked like a boi... Read more
I had a bad headache and started with a temp. Then I had some swelling that almost looked like a boil. I was hurting all over and could barely stand up. They say I had cellulities. I was given a booster shot and some antbiotics. I was shaky and could hardly eat,
70 2021-06-16 crying, depressed mood Same day of the vaccine when I got home I was feeling depressed I started crying for no reason & fel... Read more
Same day of the vaccine when I got home I was feeling depressed I started crying for no reason & felt low on energy, The next day I felt fine again but on 02/01/2021 I got a pain burning sensation on right breast. On 02/02/2021 I had an appointment with my cardiologist while I was waiting in the room I started feeling sick. The doctor said my blood sugars where down. She sent me home with a monitor to check my heart for 10 days. When I went back I told her that I get a pain on my breast that shoots towards my lung and it made it painful then she also sent me to get a CT scan. I had a swollen Lymph node. My heart was fine they said I needed to walk and everything started getting better but they weren't abele to tell me if it was vaccine related.
70 2021-06-16 disorientation Nausea, High fever-102, Muscle pain, vomiting, Muscle weakness, stomach ache, dizziness, hot flashes... Read more
Nausea, High fever-102, Muscle pain, vomiting, Muscle weakness, stomach ache, dizziness, hot flashes, disorientation, fatigue
70 2021-06-17 confusional state WEAK THE ENTIRE NEXT DAY. COULDN'T UNDERSTAND THINGS PEOPLE WERE SAYING TO HER REPORTED SHE FELT LIK... Read more
WEAK THE ENTIRE NEXT DAY. COULDN'T UNDERSTAND THINGS PEOPLE WERE SAYING TO HER REPORTED SHE FELT LIKE SHE WAS GOING TO DIE
70 2021-06-18 insomnia patient began experiencing insomnia after her first vaccine. She didn't think much of it, thinking i... Read more
patient began experiencing insomnia after her first vaccine. She didn't think much of it, thinking it would subside over the next few days or week. Patient received second vaccine and still is having insomnia. It is now June and she can't get a full night of sleep. Patient has not had this issue before receiving the vaccine.
70 2021-06-21 feeling abnormal The first shot I only had arm soreness for about a week, I got the second shot at 8am and the next a... Read more
The first shot I only had arm soreness for about a week, I got the second shot at 8am and the next afternoon at 2pm I had a temperature of 101, chills, and body aches. I felt like a truck had hit me, and by 10pm I was fine. I had the 1st shot on 01/16/2021 and before 01/30/2021 I had a very red itchy patch about the size of a dime on my right foot and as the months have gone its progressed to 2in long by 1in and a half wide. The skin was itchy, bumpy, red, very irritated even when I got in the shower. I went on 02/02/2021 to one doctor he said it was just a rash and it will go away. Then I went to another doctor on 04/06/2021 and she gave me 1% of hydrocortisone to make it quit itching and by that time it was probably and 1 long and 1 in wide and it was itching and hurting. Then I called my dermatologist on 06/01/2021 and she gave me oral medication. She did a swab on it and it came back negative. Now I can take a shower without it hurting so bad.
70 2021-06-21 loss of personal independence in daily activities, impaired work ability !Intense, rapid heartbeat! Fever, pain shooting down legs, fatigue second shot 3/3/21 produced 102... Read more
!Intense, rapid heartbeat! Fever, pain shooting down legs, fatigue second shot 3/3/21 produced 102 degree fever, fatigue, much more pain in the left arm Continued intense fatigue, trouble keeping up with household chores, work PCP MD did not know what to make of this since bloodwork look normal.. I am concerned about the impact of the vaccine on my heart and how to get help for this.
70 2021-06-21 loss of personal independence in daily activities Over last few months neuropathy and back pain have escalated to the point of being bedridden. I have... Read more
Over last few months neuropathy and back pain have escalated to the point of being bedridden. I have not done anything out of the ordinary to explain symptoms. Neuropathy pain exists all day instead of occasionally at night. Can?t walk or stand for more than a few minutes at a time and back pain is non-stop, whereas before I could perform daily tasks.
70 2021-06-23 confusional state, agitation, mental status changes 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 2021-06-28 sleep disorder a few weeks afterreceiving vaccines, I started feeling tired, noticed in february, became so bad pai... Read more
a few weeks afterreceiving vaccines, I started feeling tired, noticed in february, became so bad pain in my hips, knees somedays i just lounged around not even leaving. it became my home. I couldn't sleep thru the night due to the pain in my hips, became increasingly hard to navigate the stairs in my home. It became less severe approximately in May ,helped by pain medication. At times I seem to have spasms in my hips , bone pain also.
70 2021-06-30 sleep disorder Some weeks later i awoke in the middle of the night with extreme bilateral weakness and pain in my e... Read more
Some weeks later i awoke in the middle of the night with extreme bilateral weakness and pain in my extremities. After about two months I have now been tentatively diagnosed as having polymyalgia rheumatica.
70 2021-07-06 crying 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 2021-07-08 anxiety As soon as I got home I took ibuprofen right away and it alleviated the pain in my arm. In the middl... Read more
As soon as I got home I took ibuprofen right away and it alleviated the pain in my arm. In the middle of May I started having the anxiety attacks. I would wake up with this feeling of anxiousness, kind of a tingly feeling, and sometimes it would go away after I got up but then it just kept happening. I contacted my doctor and he suggested that I go to psych nurse and we tried some anti anxiety medicine and I tried Propranolol but it didn't seem to work. I was trying CBD oil but it didn't really work. I thought on my own that my thyroid has been out of balance-it has happened before- and I knew anxiety was one of the symptoms. I asked if I could get my blood tested for thyroid and sure enough I was hyperthyroid. I told the psych nurse that we found out my thyroid was hyperactive and to wait and see how the anxiety went away. After 6 weeks getting my labs, I found out I was hypothyroid because they decreased it too much. The anxiety is gone away, and the psych nurse said it was just my thyroid. She discharged me from her. Now I'm just trying to adjust my thyroid right now. I have to wait 4 weeks to be retested. I'm taking every other day dosage. They dropped me from 75 mg to 50 so it's alternated day by day and so we're waiting to see if it's taken care of. My arthritis started acting up around the same time and I know that I have arthritis in fingers but it was never much of a problem as it is now. It feels really stiff right now and I can barely make a fist. This started around same time as hyperthyroid symptoms and it's still ongoing. I added glucosamine chondroitin for joints but it seems like that with the turmeric that it's not helping much.
70 2021-07-08 anxiety Pt reported hives to vaccine. She says that she woke up with lip swelling,itchy welts on her back an... Read more
Pt reported hives to vaccine. She says that she woke up with lip swelling,itchy welts on her back and legs in middle of night approx 12 hrs after receiving vaccine. She felt more short of breath but says she was also having a lot of anxiety. She used inhaler, and 2 atarax pills with resolution of SOB and rash within 2 days. Sweats/chills continued for ~1wk. On 4/15, pt still had swelling and redness ""like a welt"" at site of injection. She did not have fever. She had shoulder pain and some tingling of area. Pt presented to ED for evaluation due to elevated WBC (12.67) and other symptoms. ED did not believe it was cellulitis or any other emergent condition. Increased anxiety and SOB persisted >1mo but may not be due to vaccine as pt has numberous underlying health conditions. Allergy/adverse reaction was not reported until 7/6 while being seen via telephone visit for recent Positive FIT.
70 2021-07-09 memory impairment 'Flu symptoms, severe headache, covid arm, total arm rashes, out of breath, toenails curled, memory ... Read more
'Flu symptoms, severe headache, covid arm, total arm rashes, out of breath, toenails curled, memory issues, tinnitus increased, "needles" sensation at vaccine site, stomach ache, fatigue, join pain (especially hips), anaphylactic shock to Clindamycin.
70 2021-07-13 loss of personal independence in daily activities, fear The day after (24 hours later) the 2nd dose I began to experience light headedness, nausea, a pain o... Read more
The day after (24 hours later) the 2nd dose I began to experience light headedness, nausea, a pain on the left temple and extreme fatigue. I have had these symptoms still to this day as I write this on July 14, 2021 and it is the entire day log. Tylenol has not helped and that is all I can take for I am allergic to Aspirin. This has taken away all ability to function on any normalcy whatsoever. I am chronically fatigued each day and my head hurts continuously. The doctor Ondansetron HCL 8 mg on 6/21/21 which did not one thing to relieve my symptoms. I am very concerned and may add "scared" about this not going away and really need to report this in case it will help me or anyone else having this difficulty. Thank you for giving me the platform to do so.
70 2021-07-16 feeling abnormal Got shot, arm started hurting, severe pain, all day, I was fatigued, next day I ended up with chills... Read more
Got shot, arm started hurting, severe pain, all day, I was fatigued, next day I ended up with chills, body aches, I developed a fever that went to 103.0, dizzy, generally did not feel good, body sweats, weakness, loss of appetite, nauseous. This all lasted about 7 days
70 2021-07-18 impaired work ability About 7-10 days later, I started breaking out from the knees down with a horrific rash especially on... Read more
About 7-10 days later, I started breaking out from the knees down with a horrific rash especially on my left side. It was multiple itching points. I was up at 3am pouring alcohol on the itchiness. I contacted the doctor who prescribed steroids. I did not take it because my doctor suggested it might compromise the shot. It lasted about 2-3 weeks and I still have scars. I missed work for 3 days due to the itchiness. I am left with little scars on my body from the itchiness.
70 2021-07-21 crying after the patient received the vaccine she waited approx 20 minutes in our waiting area and then we... Read more
after the patient received the vaccine she waited approx 20 minutes in our waiting area and then went around the store to do some shopping. I did notice that when she arrived to the pharmacy and when she went into to the vaccine area that she was limping and favoring her right leg. roughly 30 min after she left, one of our associates came to the pharmacy asking for me aid about this patient. When I arrived to the patient she was clutching a a display end cap and stating that her right knee was in extreme pain and crying. I called the patients PCP and told them what had happened to our mutual patient. the patients daughter in law arrived shortly after and took her to her PCP.
70 2021-07-28 feeling abnormal 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
70 2021-07-28 sleep disorder The pain starts deep in my arm at the site of the injection, it radiates out in a cone shape about 4... Read more
The pain starts deep in my arm at the site of the injection, it radiates out in a cone shape about 4 inches in diameter. It's like a burning sensation. It wakes me up at night. I go to bed with the Aspercreme. I went to the doctor about 2 months ago for something else and I mentioned this pain to my doctor and she sent me to get an x-ray of the shoulder and it showed arthritis and suggested physical therapy because I had a hard time moving.
71 2021-01-04 restlessness patient in waiting period post vaccine - received at 1738 p. Approx 6 pm, pt complained of not being... Read more
patient in waiting period post vaccine - received at 1738 p. Approx 6 pm, pt complained of not being able to take a deep breath. Was anxious prior to receiving vaccine. Skin warm, dry and pink. RR 18, BP 150/86, HR 72. States doesn't feel bad, but was restless and states I cant take deep breath. Refused ED, asked patient to wait for additional 20 minutes or so. Gave water/snacks. After 20 minutes, pt reported feeling better and wanted to leave.
71 2021-01-08 feeling abnormal Approx 10-15 mins after I experienced a cloudy vision for a few seconds, after rapid blinking 10-15... Read more
Approx 10-15 mins after I experienced a cloudy vision for a few seconds, after rapid blinking 10-15 times vision returned at the same time I felt a tightening of muscle or spasm sensation starting from behind my right ear moving around the base of my head to the middle this tightening sensation was very alarming and after getting stronger I alerted the nurse who monitored my condition and had me to stay longer than the 30 mins required. I felt not myself after reaching the lobby and sat a little while there. Once home took tylenol and rested for while woke with horrible headache including the next day.
71 2021-01-10 feeling abnormal Client reported waking up around midnight on 1/8/2021, that she had a Temp of 100 degrees, chills, w... Read more
Client reported waking up around midnight on 1/8/2021, that she had a Temp of 100 degrees, chills, whole body ached, felt really bad, this lasted about 24 hours.
71 2021-01-11 fear after the shotI saat 15 miuntes. let started haveing trouble with mt throat . it started to close ! ... Read more
after the shotI saat 15 miuntes. let started haveing trouble with mt throat . it started to close ! I went back to where I got the shot, they hit me with an Epic pen and they called 911. I felted as if I was going to pass out . was taken to The ER , they treated me wit three different meds and keep me tere for a few hours ang sent me home with meds to take . theysaid if I should hve any more problems come back. and That I was There first csae like this from the shot.. I was plenty scared.
71 2021-01-12 confusional state Chills, body, body aches, headache, blurry vision all 1-8-21 then nx day 1-9-21 loss of balance, co... Read more
Chills, body, body aches, headache, blurry vision all 1-8-21 then nx day 1-9-21 loss of balance, confusion, Night of 1-11-21 loss of vision for several hours, could not see to dial the phone for help, no one else at home, stayed up most of night, could see in am still slightly blurry, made emergency appt with eye doctor. eye doctor stated no permanent vision damage.
71 2021-01-13 feeling abnormal Tingling around lips. Feeling weird
71 2021-01-14 excessive sleepiness nausea fatique headache sleeping 20 hrs per day
71 2021-01-15 anxiety itchiness at injection site, anxiety. removed injection site bandage and extended monitoring. patie... Read more
itchiness at injection site, anxiety. removed injection site bandage and extended monitoring. patient reported feeling better and no additional or increase of symptoms.
71 2021-01-18 insomnia 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 anxiety Approximately after 20 minutes after vaccine administration, my throat felt numb and i could not s... Read more
Approximately after 20 minutes after vaccine administration, my throat felt numb and i could not swallow my saliva, no acute breathing difficulty , I could not swallow water , I was very anxious and went back to facility I got vaccine , The attending doctor administered Benadryl I 50 mg IM , and then EPI 0.3 mg . EMT was called , and ED at Hospital i was attended , and Solumedrol 1.25 mg was administered IV and Pepsid for GERD , i also had, I was observed for a few HRs and skript for Prednisone and Benadryl was issued. I was then feeling better,
71 2021-01-26 sleep disorder Injection site pain and tenderness within an hour of injection. Headache, chills, body aches, musc... Read more
Injection site pain and tenderness within an hour of injection. Headache, chills, body aches, muscle pain, joint pain, fatigue within 7 hours. Difficulty sleeping, fever of 100 degrees upon awakening with continuation of above side effects. Used Tylenol, drinking fluids.
71 2021-01-27 confusional state 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 feeling abnormal immediate feeling like numbness in left index finger followed by thumb, odd feeling in left armpit w... Read more
immediate feeling like numbness in left index finger followed by thumb, odd feeling in left armpit with in 6-7 minutes continued in forehead 20 minutes later and continuing until I took benedryl. 1/28/21 stabbing pain im various spots but not continuous, left triceps, headache, and some index/thumb numbness continues 1/28/21. New is shoulder /neck pain on left side.
71 2021-01-27 feeling abnormal 24-36 hours of feeling extra tired, foggy brain, weak knees & fluttery stomach, & sore injection sit... Read more
24-36 hours of feeling extra tired, foggy brain, weak knees & fluttery stomach, & sore injection site with redness at the area. Then I returned to normal.
71 2021-01-27 sleep disorder At 10pm on 1/26/21 I experienced severe pain in my right wrist. The pain kept me awake all night. ... Read more
At 10pm on 1/26/21 I experienced severe pain in my right wrist. The pain kept me awake all night. In the morning I could not touch my wrist, move it without extreme pain. The pain level was a 10/10. I made an appointment with a doctor but was not able to be seen until February 24. I took advil, wrapped it in an ace bandage with no relief. Around 4:00 pm on 1/27/21, I realized that the pain was gone. I tried moving my wrist and was able to. After that I had complete motility and no pain. Is this related to the vaccine? I've never experienced this before.
71 2021-01-28 sleep disorder Redness and swelling and hard lump at site. Almost gone in 3 days. Then redness swelling and itchin... Read more
Redness and swelling and hard lump at site. Almost gone in 3 days. Then redness swelling and itching came back much worse. Large hard itchy lump feels hot but no longer sore. About 1 or 2 inch raised hard warm spot at injection site now. No fever headache or other symptoms. Itching bothers Sleep a little.
71 2021-01-29 nervousness Injection on Jan 22, no problems at first but 6 days later, shivery on Jan 28, then itchy rash on ... Read more
Injection on Jan 22, no problems at first but 6 days later, shivery on Jan 28, then itchy rash on left arm near injection site noticed about 7p.m. on Jan 29 and spread a little more on Jan 30. I feel a little shaky but may just be panicky. No treatment thus far.
71 2021-01-29 sleep disorder An hour after the vaccination, pain, swelling, and heat in right arm at injection site. Too painful ... Read more
An hour after the vaccination, pain, swelling, and heat in right arm at injection site. Too painful to sleep the night after the injection. Could not use right arm without moderate pain. Second day after vaccine, chills, and fatigue. Third day arm still hurt but felt better. Fourth day, headache, more chills and fatigue. Ten days after vaccine, no pain in arm but there is swelling, redness, and mild itching at vaccination site and the skin feels hot.
71 2021-01-29 sleep disorder Significant pain at injection site, mild swelling, interfered with sleep, pain in shoulder joints. ... Read more
Significant pain at injection site, mild swelling, interfered with sleep, pain in shoulder joints. Started acetaminophen morning after injection at 10.30. Took every four hours and at bedtime. Slept well last night and pain diminished in morning. Continuing acetaminophen second day and pain is diminished. I feel much better.
71 2021-01-30 feeling abnormal 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 2021-02-01 feeling abnormal 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 2021-02-03 insomnia Fever, muscle aches, weakness, dizzy spells, lack of sleep, back pain, pain at injection site. Head... Read more
Fever, muscle aches, weakness, dizzy spells, lack of sleep, back pain, pain at injection site. Headaches, whole body pain.
71 2021-02-05 insomnia Very sore arm, cold chills, loss of appetite, very weak, Vomiting (3 times) couldn?t sleep
71 2021-02-07 sensation of foreign body neck hot, body chills, lump in throat
71 2021-02-07 sleep disorder The left arm was sore following the injection, same day. Woke me up during night when I would turn i... Read more
The left arm was sore following the injection, same day. Woke me up during night when I would turn in bed. But not bad (level 3 of a 1-10 chart). Following morning, I had a slight foggy headache, but not bad. Approximately 9:30, my joints (knees, elbows, hands, shoulders, ankles - started becoming uncomfortable and hurting. I took 800 mg of Ibprofen about 10:00 am and around 12 - 1:00 realized I did not have any more discomfort. That was it. It did not come back. No more headache either.
71 2021-02-07 sleep disorder pt stated her arm started itching under the injection site which worsened over night. The itching ... Read more
pt stated her arm started itching under the injection site which worsened over night. The itching woke her up and noticed left arm turned red. The red spot is 2/ 1/2" x 1 1/2 "in size then got bigger in size and now covers the majority of her upper arm. Pt has not contacted her PCP at this time.
71 2021-02-08 confusional state fever of 103.3, confusion and fatigue, treatment initiated by physician symptoms lasted 2 days, Res ... Read more
fever of 103.3, confusion and fatigue, treatment initiated by physician symptoms lasted 2 days, Res is back to baseline.
71 2021-02-08 loss of personal independence in daily activities Same night tried to to to bathroom and couldn't get out of bed. Upper arms and thigh muscles would n... Read more
Same night tried to to to bathroom and couldn't get out of bed. Upper arms and thigh muscles would not work. Weakness lasted for 4 days. Gradually got better. Still a little weak. 5th day arm got really red and itchy. Lasted for a week.
71 2021-02-09 feeling drunk Feeling "drunk" and unbalanced. Went to bed early and felt ok next day except for pain in my arm. ... Read more
Feeling "drunk" and unbalanced. Went to bed early and felt ok next day except for pain in my arm. I noticed 2 days later there was a rash at the injection site. As a Practitioner, I I do counseling and I've noticed 2-3 people have complained of deep depression that started next day of vaccine and still is ongoing. Concerned about youth, who are already suffering depression, and what this will do to them.
71 2021-02-09 insomnia, feeling abnormal 1/23/21 3 hours after injection: burning all over the body, low voltage electrical feeling througho... Read more
1/23/21 3 hours after injection: burning all over the body, low voltage electrical feeling throughout body, right eye lid drooping, insomnia, elevated tinnitus level. 1/24/21 Continued same symptoms plus itching, left arm sore and swollen 1/25/21 Continued symptoms listed above plus redness/flushing in cheeks. Lips feel swollen but do not appear swollen 1/27/21 Continued symptoms plus asthma like breathing, tightness in bronchioles and cough 1/28/21 Continued symptoms plus headache, fatigue 1/29-1/30/21 All symptoms continue 1/31/21 Asthma symptoms improving, cough intermittent. Continued burning, electrical feeling, itching, flushing in face, eye lid drooping. 2/1-2/10/21 Continued symptoms of burning, electrical, itching, eye lid drooping, occasional cough, elevated tinnitus levels.
71 2021-02-09 sleep disorder Had shot on 2/9, woke up 2/10 very sore shoulder..couldn't sleep on it. Feeling nauseous...temp var... Read more
Had shot on 2/9, woke up 2/10 very sore shoulder..couldn't sleep on it. Feeling nauseous...temp varied from 99.3 to 100.2 vomited then felt better, but still had temperature
71 2021-02-11 anxiety, feeling abnormal After receiving the Moderna Covid-19 Vaccine at 9:40 am, the patient reported to observation. Patien... Read more
After receiving the Moderna Covid-19 Vaccine at 9:40 am, the patient reported to observation. Patient reported to the nurse that she " felt weird " with a warm flushing/tingling feeling in arms and chest. No redness or flushing noted . Patient stated that she had been anxious over the vaccination. Vitals : 9:57 133/95, HR 96, 02 98, 10:02 am 145/95 , HR 95, 02 97 , 10:07 am 144/84, HR 82, 02 98, 10:12 am 147/89, HR 76, 02 97, 10:17 am 144/88, HR 77, 02 97. By 10:12 am pt reported feeling better. Released to go home at 10:20 am with instructions to contact MD or ER if symtpoms return . Patient stated that she had taken her blood pressure medication in the AM.
71 2021-02-11 impaired work ability 6 hours after injection - began low grade fever - body, muscle aches- weakness- 12 hours after injec... Read more
6 hours after injection - began low grade fever - body, muscle aches- weakness- 12 hours after injection - high fever 102 for 3 hours chills sweats - all other symptoms persisted and I began to have a very strong METALLIC TASTE in mouth. Very ill; 3 days after Metallic taste still present still not feeling well. missed 3 days work; By Friday 4 days after- feeling much better - Metallic taste still present but seems to be a bit less.
71 2021-02-11 poor quality sleep, restlessness 1 hr: site pain and swelling ; 12 hrs later dizziness; 16 hrs later nausea, fever (101.4), increased... Read more
1 hr: site pain and swelling ; 12 hrs later dizziness; 16 hrs later nausea, fever (101.4), increased pain, chills, headache over 5 hr period; 24 hrs later headache , site pain and swelling persist; fatigue (perhaps due to restless sleep), 2nd night fever, headache , restlessness; day 2, swelling subsides sore to the touch, dull headache. First night confirmed the vaccine is the way to go to avoid these symptoms and the virus
71 2021-02-13 anxiety I received a Moderna Covid-19 immunization on 2/1/2021. Here are the after effects I am experiencing... Read more
I received a Moderna Covid-19 immunization on 2/1/2021. Here are the after effects I am experiencing: (1) mild sore throat and mild flu-like symptoms (slight headache, malaise, & fatigue) beginning 3 days after my shot continuing to this day, 13 days after shot (2/14/2021). (2) A lump, between the inside of my mouth & the outside of my cheek, which began on 2/6/21, 5 days after Covid-19 Moderna vaccination. On 2/6/21, I discovered a raison-size lump in my cheek. I could feel it with my tongue. By midnight, swelling visible from outside, in the mirror, was .5 inch from top to bottom & 1.5 inches from side to side, from below the left edge of my mouth toward the middle of my mouth. On 2/7/21, at 1:30 p.m., I could see the lump in the mirror, inside of my mouth, about .75" wide; I could see it from the outside of my cheek in the mirror, a swollen area about .75" from top to bottom & 1.5 inches wide. I felt puffiness, which I couldn't see, which extended 4" up my cheek & down across the visibly puffy area. Slightly after midnight on the morning of 2/11/21, what I felt with my tongue was between the size of a raison & an almond; from the outside, the swelling was about .75" from top to bottom & 1.75" across. Now, 13 days after my vaccine shot, the lump has receded to be about the size of a BB and the swelling outside of my mouth is going down. Is this a Covid-19 vaccination reaction? Is it serious? I read in the Washington Post that folks who have a reaction to shot #1 tend to have more of a reaction to shot #2, so that makes me anxious. Should I even take shot #2?
71 2021-02-13 sleep disorder The night of the vaccine Sleep disturbance, sore muscles, can't get comfortable, left arm ache, bod... Read more
The night of the vaccine Sleep disturbance, sore muscles, can't get comfortable, left arm ache, body aches -- neck, legs, hands, feet. Overall tiredness. Chills, but no fever. These symptoms carried over into the second day of having the vaccine.
71 2021-02-14 disorientation Lips tingling and disorientation: started 02/12/2021 @ 12:00 - ended 02/12/2021 @13:00 Headache, lo... Read more
Lips tingling and disorientation: started 02/12/2021 @ 12:00 - ended 02/12/2021 @13:00 Headache, low-grade fever 99F, slight chills, and night sweats: started 02/12/2021 @ evening - currently experiencing
71 2021-02-15 sleep disorder I received the vaccine at 3;30 in the afternoon of 2/12/21. I felt fine and after waiting for 20 min... Read more
I received the vaccine at 3;30 in the afternoon of 2/12/21. I felt fine and after waiting for 20 minutes, I drove home. I had no pain at the injection site and did not need any medication. I ate dinner and went to bed at 10:30 pm. I awoke at 1:30 am with pain in my mouth. I had had a temporary bridge put in my upper right side of my mouth on Tuesday, 2/9/21. I had had no pain from that dental procedure till 2/13/21 at 1:30 am. I needed to take an Advil to relieve the pain. After 20 minutes the pain was gone. This pattern of waking at night with pain has continued since that night. I called my dentist today and reported what was going on. He told me to get in touch with the CDC and file a report. He reported that he has heard of this pain occurring in other dental patients after having received the vaccine.
71 2021-02-16 excessive sleepiness 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 anxiety Patient experienced lip tingling starting 18 minutes after 1st dose of Moderna vaccine. Within 1-2 m... Read more
Patient experienced lip tingling starting 18 minutes after 1st dose of Moderna vaccine. Within 1-2 minutes, upper lip, then lower lip began swelling. Patient was very anxious, unsure if throat was swelling. Patient had history of similar reaction and epipen use with ciprofloxacin. Epipen was injected to right thigh at approximately 20 minutes after vaccine dose. Pt complained of throat swelling. Ambulance arrived within 5 minutes and patient was transported to medical center for further observation and treatment.
71 2021-02-18 disorientation 12 hours after injection total body aching and feeling cold started. Got up in middle of the night f... Read more
12 hours after injection total body aching and feeling cold started. Got up in middle of the night for bathroom . made it to bathroom before I couldn't hold urine. Remember thinking "O my gosh" Disorientated trying to get back to bed. Kept running in to walls. 75 hours after injection still not fully recovered but feeling much more normal.
71 2021-02-18 excessive sleepiness strong chills, cold, sleeping and unable to stay awake. No fever but chills and felt like was in a r... Read more
strong chills, cold, sleeping and unable to stay awake. No fever but chills and felt like was in a refrigerator. Lasted until approximately Noon on 2/5/2021
71 2021-02-18 sleep disorder Moderna COVID-19 Vaccine EUA Site of injection increasingly sore. Unable to sleep. Chilled the mo... Read more
Moderna COVID-19 Vaccine EUA Site of injection increasingly sore. Unable to sleep. Chilled the morning after the injection. Continued to increase in soreness through the next day. Unable to sleep next night. Took 500 mg acetaminophen at 1 am, 2/19/21. Still sore.
71 2021-02-19 insomnia The night I received the shot I had a headache, muscle aches, chill, fever 100.3. I went to bed bund... Read more
The night I received the shot I had a headache, muscle aches, chill, fever 100.3. I went to bed bundled in clothes to get warm but could not sleep. The pain in my muscles made it impossible to relax. I finally called the Hot Line at 12:47am. I asked them if I could take some Tylenol. They said that my reactions were normal and I should tough it out. The vaccine was doing it's. i continued to suffer all night. I alternately placed a heating pad on my legs, lower back and neck. This gave me some relief but no sleep. At 8am my doctor returned my call and said it was OK to take Tylenol and that I could have taken it last. She said that it was not recommended to take any Tylenol before receiving the shot. Darn. I slept all day 02/19. This morning I noticed that I had a rash and lump below the injection site it is warm to the touch but not itchy.
71 2021-02-22 excessive sleepiness About 24 hours after receiving vaccine, I developed myalgias, severe headache, stomach bloating, nau... Read more
About 24 hours after receiving vaccine, I developed myalgias, severe headache, stomach bloating, nausea, dizziness, and extreme fatigue and hypersomnia. I fell asleep suddenly for hours at a time. The symptoms lasted for six days after receiving the vaccine, with fatigue and hypersomnia lasting the longest. I missed work due to the symptoms.
71 2021-02-23 anxiety 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 loss of personal independence in daily activities, insomnia Wed. 2/17/2021: Within 30 minutes of shot, left arm burning/sore. Within 45 minutes hip/joint pain... Read more
Wed. 2/17/2021: Within 30 minutes of shot, left arm burning/sore. Within 45 minutes hip/joint pain, difficulty walking. Within 1 -2 hours fatigue. By evening, hip and fatigue issues gone. Soreness in arm much worse. Difficult to lift arm/change clothes. Almost no sleep that night - pain in arm. Did not take anything for it. Thu. 2/18/2021: Muscle soreness in arm worse. Hard to move. Had to lift left arm with right to get to table to type in computer or eat. Little sleep Thursday night - pain in arm. Did not take anything for it. Fri. 2/19/2021: Muscle soreness in arm same - bad - upon awakening. As day progressed, it got better. By evening feeling "okay." Able to sleep. Sat/Sun/Mon 2/20/2021, 2/21/2021/2/22/2021 - no pain in arm Tue 2/23/2021 - noticed very slight muscle soreness in arm in evening Wed 2/24/2021 - noticed more muscle soreness in arm as day progressed; hurt to take tee shirt off in evening Thu 2/25/2021 - woke up with much more muscle soreness in arm - felt like a rerun of Friday 2/19. Am sending this in as a result.
71 2021-02-24 sleep disorder 11 hours after shot chills and high temperature. I couldn't sleep...I took something for the fever.... Read more
11 hours after shot chills and high temperature. I couldn't sleep...I took something for the fever. I was dizzy and nauseous. It was hard for me to leave my bed. My joint felt inflamed. Early this morning I fell asleep and when I work up at 11 am I was drenched in sweat. My fever has come down but I still have a low fever.
71 2021-02-25 feeling abnormal Aches, lethargy, exhaustion, dazed feeling, headache Tylenol and rest
71 2021-02-26 disturbance in attention, sleep disorder Severe red itchy rash over torso, front & back, arms, thighs Waves of chills on a constant basis, bu... Read more
Severe red itchy rash over torso, front & back, arms, thighs Waves of chills on a constant basis, but no fever Tired, lethargic, unable to think clearly This is the 5th day since receiving the vaccine Have taken doses of 50 mg of Diphenhydramine HCL, 12-hour Claritin, Famotidine 20 mg, acetaminophen, Triamcinolone Acetonide ointment to relieve itching, Epsom salt & soda baths Still have the bad red rash-woke up in the night at 2 am and could not sleep because of itching
71 2021-02-28 disturbance in attention, impaired work ability 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 feeling abnormal, insomnia, hallucination Day 1: egg-sized red raised area at sight of injection with a good deal of pain in upper left arm D... Read more
Day 1: egg-sized red raised area at sight of injection with a good deal of pain in upper left arm Day 2 am: fever of 101.1 (normal 97.7F); collapsed in kitchen with no dizziness; extreme feeling of brain fog; swollen lymph nodes under both arms; chills; headache; fairly extreme pain at every joint with prior injury--left knee, L4-L5 high right, 4th finger of right hand; extreme fatigue, but inability to sleep though in bed all day Day 3 fever of 100; chills; swollen glands in both sides of neck; still in bed with extreme fatigue and unable to sleep; up for a couple of hours in early evening; double vision; slept for two hours Day 4 am still with extreme fatigue and unable to sleep; 5am visual hallucinations while in bed and sitting on the side of bed; still with double vision; continuing large hot red area around injection site with upper arm pain To now as I am writing this, continued fatigue and general malaise, double vision now gone.
71 2021-02-28 mental impairment, impaired work ability Two: 1. Extreme extreme pain in r arm from injection. Pt could not function. Had to cancel work... Read more
Two: 1. Extreme extreme pain in r arm from injection. Pt could not function. Had to cancel work for rest of week. 2. Became sick from vaccine. Vomited a series of six times after a few sips of tea. Later a few other sips of tea and vomited 9 times. Could not retain fluids.
71 2021-03-01 loss of personal independence in daily activities Within 5 minutes of receiving shot I felt very nauseous and dizzy. Symptoms lasted for five days. V... Read more
Within 5 minutes of receiving shot I felt very nauseous and dizzy. Symptoms lasted for five days. Very dizzy. Stomache upset. Could not leave house.
71 2021-03-01 nervousness Nausea chills nervousness pain in joints and muscles and loss of appetite
71 2021-03-01 sleep disorder Moderna COVID-19 Vaccine EUA: Approx 12 hours after receiving injection I first got a severe headach... Read more
Moderna COVID-19 Vaccine EUA: Approx 12 hours after receiving injection I first got a severe headache, for which I took ASA with some moderate relief. I then noticed body aches & chills. After about 45 minutes I went to bed, still chilled. After lying down the chills became rather violent, more like spasms or seizures and lasted about 15 minutes. Finally they stopped and I had a fitful nights sleep due to body aches & headache. On awakening I still had discomfort, took Ibuprofen, and it is still ongoing at this time (2:30 pm) but seems to be going away. Primary feeling is now weakness & fatigue
71 2021-03-02 feeling abnormal Around 4 o'clock after 2nd dose patient felt like she got hit by a truck. She had severe aches that ... Read more
Around 4 o'clock after 2nd dose patient felt like she got hit by a truck. She had severe aches that lasted until Tues 3/2/21. She had similar side effects with the first dose. She had tested positive for Covid July 2020. Developed cellulitis in the right arm. She was seen by PCP.
71 2021-03-02 excessive sleepiness 02/13/2021 evening started to feel cold and tired, slightly sore arm. 02/14/2021 woke up with fever,... Read more
02/13/2021 evening started to feel cold and tired, slightly sore arm. 02/14/2021 woke up with fever, chills, achy, lethargic, slight sore throat, decreased appetite. These symptoms continued the entire day. Slept most of the day and night. Took ibuprofen for symptoms. (Did not take prophylactically as had seen could reduce effectiveness of vaccine). 02/15/2021 symptoms improved, still achy and lethargic. Was awake most of day. 02/16/2021 woke up feeling well. Knew immediately that the symptoms were gone.
71 2021-03-03 hallucination At first I had the achy flu-like symptoms, After a while, i was Hallucinating and asking or talking... Read more
At first I had the achy flu-like symptoms, After a while, i was Hallucinating and asking or talking to my deceased parents. I couldn't walk after an hour and had to call my son to help my husband to get me up off the floor.I could not eat due to the smell of the food. I had a severe headache.
71 2021-03-03 excessive sleepiness Itchy red rash 2/18-2/27/21. Flu like symptoms 2/21-2/24/2021, but no fever - just no energy, stuff... Read more
Itchy red rash 2/18-2/27/21. Flu like symptoms 2/21-2/24/2021, but no fever - just no energy, stuffed head, headache, achy, slept 15 hours one night, 13 the next. By 2/24/21, better but still listless. Essential tremors possibly were worse until 3/1/21.
71 2021-03-03 loss of personal independence in daily activities I have basal arthritis in my thumb on my right hand and slight arthritis in the base of my right ind... Read more
I have basal arthritis in my thumb on my right hand and slight arthritis in the base of my right index finger. About 24 hours after my vaccine the flare up began in both locations. I used my normal treatments of Peppermint and Frankincense essential oils throughout the rest of the afternoon and evening, but it did not work. The pain only kept increasing and both areas became very inflamed. By 10:00 p.m. I was unable to use my thumb to support a glass of water and soreness began to develop in the base of the finger next to the index finger. I finally took an Aleve which began to relieve the severe pain within about an hour. The severe flare up was better in the morning, but it has been a week and the discomfort is still there. I bought Voltaren and hope this will get my joints back to normal, which is mild flare ups when the weather changes.
71 2021-03-03 sleep disorder 30 minutes after shot, 10:30, had extreme fatigue. 7:30 not feeling well, went to be bed. Woke at 11... Read more
30 minutes after shot, 10:30, had extreme fatigue. 7:30 not feeling well, went to be bed. Woke at 11:00 with extreme pain lower brain, neck, shoulders, upper back and arms. Vomited. I was very cold and felt chills started shaking and trembling. Placed 5 blankets on me. I started my breathing exercise to try to relax my muscles to see if I could lesson the pain that I thought was causing the nausea so I could go back to sleep. Slept off and on and finally woke to a fever of 100.4 at 5:00am. Stayed in bed the rest of the day 3/3. Fever broke at 10:00pm
71 2021-03-03 sleep disorder The injection site itched a little from the beginning. It went away in four days, but then returned ... Read more
The injection site itched a little from the beginning. It went away in four days, but then returned with a lot of itching a few days later. it got redder and bigger and the site also was warm to touch and swollen. I put ice packs on it to help with the itch, along with benedryl gel. it was difficult to sleep because of the itch. It is still getting bigger as of today. I did not go to the doctor. I followed what it said to do on the internet. The itch may be calming down some. I don't know if I should get the 2nd vaccine. Please let me know.
71 2021-03-04 sleep disorder Moderna COVID-19 Vaccine EUA When I went to bed the night of the vaccine, I noticed some soreness ... Read more
Moderna COVID-19 Vaccine EUA When I went to bed the night of the vaccine, I noticed some soreness in my back muscles and left arm. I took 2 500 mg tylenol at bedtime. I woke up about 1:30 a.m. Soreness in my back was so bad, it hurt to touch it or lay on it. I also had chills to the point of shaking and added 2 extra blankets and took another 500 mg tylenol. On Thursday, the day following the vaccine, I continued to have chills, had no appetite and had a headache. The soreness in my back lessened throughout the day and by 7:30 pm had almost disappeared. I woke up at 1 and 2 am on March5 dripping wet(I assume from fever breaking).When I got up at 5am on the 5th, all adverse symptons were gone and I ate normally.
71 2021-03-05 feeling abnormal Woke up at 11:30 p.m. the same day. I was dreaming my leg was in a white snow bank and I was shakin... Read more
Woke up at 11:30 p.m. the same day. I was dreaming my leg was in a white snow bank and I was shaking from the cold. My arms and body shook. I went to take 2 Tylenol and could barely hold the Tylenol bottle or glass with water. I put a blanket on the bed and heavy pajamas and went back to sleep. Shaking subsided. The next day I slept all day and felt like I was run over with a truck, my temp was 99.4.. The next day I felt fine.
71 2021-03-06 confusional state Violent head, joint and body pain, watery diarrhea, chills and sweats, extreme lethargy and sleepine... Read more
Violent head, joint and body pain, watery diarrhea, chills and sweats, extreme lethargy and sleepiness, confusion, abdominal pain, extreme nausea, loss of balance
71 2021-03-06 feeling abnormal Awoke that night needing to throw up and had difficulty walking, a very dangerous situation, felt so... Read more
Awoke that night needing to throw up and had difficulty walking, a very dangerous situation, felt so ill, fell asleep sitting in chair in bathroom could not get to toilet. Very weak and felt horrible.
71 2021-03-06 sleep disorder A very sore left arm with deep hematoma at injection site, developed by around 9pm. Overnight more p... Read more
A very sore left arm with deep hematoma at injection site, developed by around 9pm. Overnight more pain and fever, hard to sleep. Took Tylenol but the last few hours before the next dose were very painful. 10 am this morning temp 99.9º with headache and muscle aches. At 2pm temp 101º. Arm got better slightly after Tylenol but waiting for the next dose it is very painful again.
71 2021-03-07 feeling abnormal 1st dose 1/29 reaction gave me little dime-sized red bumps all over my body and a lot of itchiness. ... Read more
1st dose 1/29 reaction gave me little dime-sized red bumps all over my body and a lot of itchiness. I had 2 larger brown places on my body that were oval shaped about 1 inch across and it was crusty and had liquid and blood coming from it. One was under my left breast and at the base of my spine. I had to get a mammogram because I had brown and bloody discharge from my left nipple. It looked like someone had painted bright red paint around the nipple. Dermatologists said it was mild duct ectasia bilaterally benign, nipple dermatitis, left nipple bloody discharge, and an eczamatatious rash. Right breast had a brown bump on the areola to the side of the nipple. 03/03/21 second dose: Sore arm, Fever of 100.9 next day that lasted all day. fatigue and a headache. I also had dizziness especially when I lie down or get up. fever went down and then I developed a rash on my body that made it look like I was sunburned all over my body. not spots, just redness all over. I felt pretty weird. it was an itchy rash that stayed about 24 hours, then changed into a spotty rash that traveled to my inner arms and inner thighs. The next day it traveled down my legs to my ankles. It went away mostly after a few days. I do still have spots that look like bites that are quarter-sized brown crusty spots. then I have eczema patches on my forehead. Its flaking and itching and is too sensitive to wash with soap. Also, my right eyelid has 3-4 places that has welt on it so much so that I cant see well from the eyelid, and under eye being swollen.
71 2021-03-07 loss of personal independence in daily activities I had my 2nd dose of Moderna Vaccine on 3/4/2021 @ 8:40 AM. By 2 PM I experienced extreme fatigue fo... Read more
I had my 2nd dose of Moderna Vaccine on 3/4/2021 @ 8:40 AM. By 2 PM I experienced extreme fatigue for the remainder of the day. Unable to perform simple tasks like preparing dinner. On 3/5/21, I woke with a fever of 100.4 F, and general flu like symptoms: Killer headache, body aches, cold chills. My fever didn't rise above 100.6 F and the headache was untouchable with Tylenol or Advil. On 3/6/2021, My fever was gone but my left arm at the injection site was very red swollen and very warm to the touch. Just when I thought everything was OK, Yesterday 3/7/2021, I had a bout of diarrhea from about 10 AM until 3 PM only to be followed by swollen glands of my neck on the left side, it was so painful to turn my head, swallow and speak. There was no fever. Today, 3/8/2021, I can speak, and turn my head without discomfort, swelling is down, but when I swallow I still have some mild pain. My reason for telling you all if this is that I believe the symptoms of diarrhea and swollen neck glands ( only on the left side, injection side) are not listed anywhere that I could find. Has any one else reported similar symptoms? Thank you for your time and all you do!
71 2021-03-09 disturbance in attention started 3/5/2021 tired, scattered thinking, sore developed above top lip. muscle in both leg... Read more
started 3/5/2021 tired, scattered thinking, sore developed above top lip. muscle in both legs and into top of feet painful til 3/10/2021
71 2021-03-09 excessive sleepiness LETHARGY, NAUSEA, HEADACHE, SHORTNESS OF BREATH, FATIGUE, FEVER>100, SLEPT FOR 36 HOURS
71 2021-03-09 excessive sleepiness 2nd day, upon rising. Symptoms, extreme dizziness, shaking, exhaustion, itching. Difficulty to sit ... Read more
2nd day, upon rising. Symptoms, extreme dizziness, shaking, exhaustion, itching. Difficulty to sit up or navigate. Stayed in bed the whole day. Next day, no symptoms at start but symptoms returned in the afternoon, slept for 3 hours then seemed better.
71 2021-03-09 loss of personal independence in daily activities At about 11:00PM, on 3/3/2921, I got ready for bed and stretched and attempted to take a big breath.... Read more
At about 11:00PM, on 3/3/2921, I got ready for bed and stretched and attempted to take a big breath. However I felt as though I could not expand my chest wall. So I waited a moment and after 2 attempts I was able to expand my chest wall. This symptom has improved and is occurring less frequent, but it is still there. It feels as though I have to think the process of taking a big breath through. Over the following days I experienced pain in my joints and muscle aches. On day 2 I began to experience severe pain at he old surgical site on my lower back. The pain radiated down my right leg which is the same leg that was involved when I injured my back it got so The pain also went into my right hip. It got so bad that on day 3 my daughter came to stay with me until I could walk upright and my pain began to resolve. I was able to walk again by day 4. However, the pain in my leg still is restricting my movement and my ability to stand up and walk again. I require some assistance to stand from a squat or sitting..
71 2021-03-09 sleep disorder In the days and weeks after receiving the Moderna vaccine, I had a variety of headaches as follows: ... Read more
In the days and weeks after receiving the Moderna vaccine, I had a variety of headaches as follows: Shooting pains in the back of my head on the right side and behind my ear; pain on the right front side of my head, usually while sleeping and waking up from the pain; one episode of waking up with pain on the left side of my head, temple, teeth and side. The headaches continue to this day, March 10, 2021, one month after receiving the vaccine. I reported the headaches to my GP, but he advised me to still get the second dose, scheduled for March 13, 2012. I am cancelling that appointment because of the headaches.
71 2021-03-10 poor quality sleep Received dose #2 at 6:00 pm on 3/3/21. Arm soreness began within 2 hours, increasing throughout the ... Read more
Received dose #2 at 6:00 pm on 3/3/21. Arm soreness began within 2 hours, increasing throughout the night; pain radiated to fingertips; iced it at 3:00 am with success. Sleep was restless, waking often, with onset of flu-like aches throughout entire body. No fever. Mid-morning headache began to increase with nausea. Difficult to keep eyes open (tiredness), eat or drink. As day progressed, so did the headache and nausea. Taken to Emergency Room at 8:00 pm. Administered Zofran IV for nausea and IV NSAID. Nausea ceased; headache dulled. Released 11:00 pm. Only headache remained through Saturday, 3/6/21.
71 2021-03-11 depression On MAIO. Severe depression started evening of day after shot (Saturday) and continued until mid-day ... Read more
On MAIO. Severe depression started evening of day after shot (Saturday) and continued until mid-day Monday. Worst in many years.
71 2021-03-11 insomnia 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 2021-03-13 anxiety Patient experienced shortness of breath and anxiety within 15 minutes of vaccine administration. No ... Read more
Patient experienced shortness of breath and anxiety within 15 minutes of vaccine administration. No indications of anaphylaxis. EMS assessed client and released to home.
71 2021-03-13 feeling abnormal, anxiety 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 2021-03-14 loss of personal independence in daily activities Patient received one shot of COVID-19 vaccine (Moderna) and the next day had a raised red itchy rash... Read more
Patient received one shot of COVID-19 vaccine (Moderna) and the next day had a raised red itchy rash on left leg from knee to ankle. The next day she experienced a headache beginning behind her left eye that then travelled down the back of her head, neck and into lower back. She had pain in lower back so much so that she couldn't sit comfortably. The next day she had bubbling and rolling stomach. The next two days she had severe diarrhea, then a spot on her face (cheek). The next day she had pain in her right foot and couldn't walk on it for a while. Her shot was administered in her right arm and she has a history of anaphylaxis with a Penicillin shot. She hasn't had anymore symptoms for about a week as of 3/15/2021.
71 2021-03-15 sleep disorder 12 after hours 2nd shot, had a fierce headache and unable to sleep all night. Finally took Tylenol ... Read more
12 after hours 2nd shot, had a fierce headache and unable to sleep all night. Finally took Tylenol every 4 hours for until noon on 3/14. Headaches eventually decreased. On 3/14 thru to the morning of 3/15, slept constantly. Was awake for a a total of about 4 hours during this time. No apetitite. Around 10am on 3/15, thought I was feeling better and started to drive to an appointment. Had to turn around because I was dizzy and went home to take yet another nap. By 4pm on 3/15, all symptons were gone
71 2021-03-17 excessive sleepiness The injection site went burning hot, from shoulder to fingertips was tingling, felt like a blow to h... Read more
The injection site went burning hot, from shoulder to fingertips was tingling, felt like a blow to head headache, back of neck hurt, couldn't breathe. She no sooner said to wait 30 mins, I turned to look at clock and bam! everything hit at once. I was told to go to ambulance on site. They put me in ambulance, covered me, gave me oxygen, and fluids via iv. Blood pressure was 189/115, heart rate was 40. Dr said I was very flushed. I was having difficult time breathing. Oh, they gave me benadryl and I believe? steroids. Had to wait for another ambulance as the one there had to stay onsite. I was taken to emergency room at hospital where I stayed on oxygen and new iv of steroids. Was at hospital for 4 hrs till bp was considered safe enough to release me. I still have head ache and neck pain, back of neck. Also sleeping much more than usual.6 Before getting shot I had asked the person giving shot if my allergies to penicillin and morphine would prevent my getting shot. I had listed these on the paperwork necessary to getting shot. She said they were looking for reactions to like the flu shot.
71 2021-03-17 memory impairment The next day i had chills, body pain, fatigue, loss of taste, headache, weakness. But on wednesday 3... Read more
The next day i had chills, body pain, fatigue, loss of taste, headache, weakness. But on wednesday 3/17/21 i had severe left leg pain from thigh going down, my lower leg got discolored ( darker than my normal color), dizzy, forgetful. Went to ED and my Bp was 185/69- never ever!! Blood test, leg ultrasound normal. Today i still have pain, headache, no appetite. This vaccine is the culprit.
71 2021-03-18 feeling abnormal 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 2021-03-18 feeling abnormal My reaction to the vaccine was: Complete and utter fatigue, going from the bed to the bathroom and b... Read more
My reaction to the vaccine was: Complete and utter fatigue, going from the bed to the bathroom and back felt like I had run a marathon, I had brain fog, headache and a temperature. I ached all over and my vision was somewhat affected. The idea of eating took too much energy. No one I have talked to had a reaction like mine. I believe there is a connection between my reaction and the Valley Fever. I would like to know if other Valley Fever survivors had similar reactions. After 36 hours like that, I feel much better.
71 2021-03-18 sleep disorder Muscular pain radiating down arm and difficult lifting arm upward. Continued for couple days, By thi... Read more
Muscular pain radiating down arm and difficult lifting arm upward. Continued for couple days, By third night, awaken with pain in forearm area, not able to straighten without pain. Continued throughout day, by night progressively worse, could not sleep, no strength in hand to open medication bottle. Still could not lift arm, when moved arm even slightly, lots of pain. Doctor discussed multiple differrntisld. Diagnosed tendinitis of right triceps which may have been aggravated by injection. Suggested treat with 1000 mg of Tylenol or 800mg of Motrin. Treated several days with Tylenol. Pain subsized, however, can still feel sometimes (uncomfortable) in forearm.
71 2021-03-18 sleep disorder Began to feel feverish around or slightly before 9:30, when chills & shivering began. Could not sle... Read more
Began to feel feverish around or slightly before 9:30, when chills & shivering began. Could not sleep due to shivering. Got up around 1 AM to go to bathroom- was VERY weak & needed help. Also while getting to bathroom began to lose control over kidneys and was urinating involuntarily. Had urge to to go the bathroom again around 3; 30. This time could NOT walk at all & was once again urinating involuntarily. Tried to just go back to bed, but did not seem to have any control over my body. Around 4:30 I got as comfortable as possible on the floor & slept off & on until around 8:30. When I woke up I was able with help to get back into bed. I had continued to urinate involuntarily during the time I was sleeping prior to 8:30. The symptoms seemed to gradually subside after this point. Called Neurologist, thinking that my radiation induced nerve damage was involved in my reaction and she agreed.
71 2021-03-22 feeling abnormal Received the shot 1.29.21 and on 2.13.21 noticed something was wrong and by 2.15.21 my arms and left... Read more
Received the shot 1.29.21 and on 2.13.21 noticed something was wrong and by 2.15.21 my arms and left leg had no strength. My left leg would not hold me up. Went to the ER.
71 2021-03-23 disturbance in attention 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 2021-03-25 feeling abnormal, loss of personal independence in daily activities, disturbance in attention, excessive sleepiness Not exactly sure what time reaction started, but I was completely unaware of surroundings and slept ... Read more
Not exactly sure what time reaction started, but I was completely unaware of surroundings and slept all day until 2:00p,m. today. I was weak all over. Fell off the couch I was sleeping on and was unable to get up due to muscle weakness. Had my son come over to get me up off the floor. I'm feeling somewhat better today. I'm able to walk and get up from a sitting position. Still feel a little brain scrambled. Unable to concentrate long enough to read the paper.
71 2021-03-26 anxiety anxiety and C/O Headache post vaccine. No medications given.
71 2021-03-26 feeling abnormal 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 2021-03-26 nightmare, loss of personal independence in daily activities, poor quality sleep It started with dizziness and progressed to fever and chills, severe body aches, restless sleep with... Read more
It started with dizziness and progressed to fever and chills, severe body aches, restless sleep with disturbing dreams, extreme fatigue and persistent low grade fever and chills too severe to do anything but stay in bed. At 2:30 pm, I took some tylenol based cold medicine, which started some improvement, and I was able to eat something. I'll take more before going to bed.
71 2021-03-29 confusional state Hospitalization for severe hyponatremia, with confusion and inability to speak which we thought was ... Read more
Hospitalization for severe hyponatremia, with confusion and inability to speak which we thought was due to colonoscopy prep, only to find out 2 days later when we brought her home that the colonoscopy prep was never taken
71 2021-03-29 fear chills/fever, severe vomiting (couldn't even keep water down for 2 days), headache, body aches, loss... Read more
chills/fever, severe vomiting (couldn't even keep water down for 2 days), headache, body aches, loss of balance Due to being a "brittle" type 1 diabetic I am reluctant to get the second shot. (Fear of dying)
71 2021-03-31 feeling abnormal 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 2021-04-02 feeling abnormal 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 excessive sleepiness 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 2021-04-04 feeling abnormal Severe headache, nausea, spike in blood pressure, foggy brain
71 2021-04-06 excessive sleepiness Sore R upper arm within an hour of injection; sudden onset of nausea, vomiting, diarrhea, fatigue a... Read more
Sore R upper arm within an hour of injection; sudden onset of nausea, vomiting, diarrhea, fatigue and severe headache 12 hours after injection; slept from 8pm on Friday 2/12/21 through till 1:30pm on Sunday 2/14/21 (except for going to the bathroom to throw up and defecate); Took promethazine, which had NO effect on the nausea. N/V/D subsided about 60 hours after onset. Headache (severe, like a vise was on my temples) subsided about 4-5 days after onset. Persistent fatigue lasted for 6 days total. I had stopped my daily tylenol and ibuprofen and zyrtec 48 hours before the injection, and did not restart them till 3 days after the injection. Tylenol and ibuprofen had NO effect on the headache, but did relieve my chronic bilateral hip-replacement leg pain.
71 2021-04-06 excessive sleepiness BODY ACHES, SLIGHT FEVER, HIGHER BLOOD PRESSURE, NAUCIOUS, SLEEPING AND STAYING IN BED FOR 3 DAYS
71 2021-04-06 excessive sleepiness Sore upper arm at injection site within 1 hour of injection. Sudden onset of nausea/vomiting/diarrh... Read more
Sore upper arm at injection site within 1 hour of injection. Sudden onset of nausea/vomiting/diarrhea and severe headache at 12 hours after injection. Slept from onset of these symptoms from 8pm Friday, 2/12/21 until 1:30pm Sunday, 2/14/21 except for bathroom visits to vomit and defecate. Took promethazine for nausea - NO effect. Headache (like a vise was pressing hard over my temples) lasted 4-5 days, with no response to tylenol or ibuprofen. Persistent fatigue throughout this time frame - lasted about 6-7 days. I had stopped my tylenol, ibuprofen and zyrtec 48 hours prior to the injection, and restarted it 36 hours after the injection at the advice of my physician.
71 2021-04-07 feeling abnormal Ran fever and had chills for 3 days--fatigue and fuzzy brain.
71 2021-04-07 sleep disorder, nightmare I already did . I don't feel well and I am not going to write more. I'm sick.
71 2021-04-08 disorientation second vaccine was at 10:30AM on 3/29/21. I experienced increased frequency of ocular migraines (Kal... Read more
second vaccine was at 10:30AM on 3/29/21. I experienced increased frequency of ocular migraines (Kaleidoscopic irregular frame in field of vision that starts small and increases in size till it disappears over 15-30 minutes. That is followed by a mild headache and mild disorientation. This has been the usual symptom of an ocular migraine for me. Difference was a big increase in frequency.) Ocular migraines occurred in PM of 3/2/21, AM on 3/3/21, AM and PM on 3/5/21, PM 3/6/21, PM 3/7/21, AM 3/11/21, PM 3/15/21, PM 3/19/21, and AM 3/20/21. I had one instance on an ocular migraine after the second Moderna dose on 4/1/21. I contacted both my PCP and Opthamologist on 3/8/21. Doctor followed up with me to find out whether the migraines were always occurring in the same field of my vision from instance to instance later in the week as well. I told him they seemed to be occurring in different spots including a perceived difference in which eye. Only treatment was to watch and see if it stayed as frequent or subsided in frequency. It seems to have resolved itself by today 4/9/21.
71 2021-04-08 memory impairment 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 2021-04-09 insomnia Could not sleep the night of the vaccine. Woke in the morning with muscle aches, joint pain, a heada... Read more
Could not sleep the night of the vaccine. Woke in the morning with muscle aches, joint pain, a headache and a temperature of 99.9, sweating. Fixed a cup of coffee and my legs gave way and I fell on the floor of the kitchen.
71 2021-04-09 sleep disorder Fever of 102.5 within 3 hrs of injection, and very swollen and painful arm. Headache becoming more i... Read more
Fever of 102.5 within 3 hrs of injection, and very swollen and painful arm. Headache becoming more intense over next 5-6 hours. 5 a.m. (14 hours post injection) woke with nausea, vomiting, much more severe headache, and runny nose. Ate something and took 1/2 Norco and 2 Advil. Headache 10 on scale of 10 painwise. Slept but woke 3 hours later with same level of headache, nausea, and temp steady at 102.5. 24 hours post injection, still severe headache (10/10), no more nausea but no appetite. Took 1/4 Norco after drinking smoothie and Pepto, slept 3 more hours. Woke 8 pm to same headache, temp still 102.5. Just gutted it out until about 2 a.m. was able to take another 1/2 Norco and 2 Advil and slept until 8 a.m., nearly 48 hours post shot. No more drugs, and headache was somewhat abated, 5/10. Appetite came back slightly, enough to eat and take two more Advil. Now 74 hrs post shot am symptom free other than persistent but slight headache.Did not contact doctor as I did not think there was anything he would have been able to do for me.
71 2021-04-09 sleep disorder Three days after second injection I broke out in rash with intense itching, burning, pain and swelli... Read more
Three days after second injection I broke out in rash with intense itching, burning, pain and swelling in the genital area.Problem so severe that I could not sleep, walk or sit without symptoms worsening. OBGYN could not identify (Other than UGH thats awful) Testing for herpies, and bacterial/yeast infection all negative. Research show that this was likely Genital Psoriasis flair. I have no history of psoriasis. Treated with numerous OTC medications and later steroid cream . 9 weeks later it is 90% resolved, but still red and sore.
71 2021-04-12 confusional state, memory impairment Transient Global Amnesis, Headache, Confusion, inability to remember recent events, asking repetitiv... Read more
Transient Global Amnesis, Headache, Confusion, inability to remember recent events, asking repetitive questions about the situation and surroundings and not recalling the answers to these questions
71 2021-04-13 insomnia I had insomnia that lasted most of the night. I went to bed at 11 and woke up at 12.
71 2021-04-13 sleep disorder 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 2021-04-15 memory impairment, feeling abnormal 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 2021-04-16 insomnia Swollen face, rash on face, feeling very tired, insomnia for 4 days prior to developing rash, rash o... Read more
Swollen face, rash on face, feeling very tired, insomnia for 4 days prior to developing rash, rash on hands 6 days after rash on face , joint pain continuing still now comes and goes in ankle, knee and wrist joints. Swollen glands under arms and in neck for two weeks. Rash was peeling from face after one week.
71 2021-04-17 loss of personal independence in daily activities 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 loss of personal independence in daily activities One hour after vaccination started to run fever had body aches and chills along with headache. These... Read more
One hour after vaccination started to run fever had body aches and chills along with headache. These lasted for 4 days. On the 5th day flu like symptoms faded but all she wanted to do was sleep. No appetite. She is 10 days out and is still very sleepy and does not feel like doing anything. The headache has not completely subsided. I advised her to call her Dr.
71 2021-04-19 anxiety 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 confusional state Sore arm, fever, chills, pain in back and hips, severe stomach ache, extreme confusion, anemia
71 2021-04-21 loss of personal independence in daily activities, sleep disorder Uncontrollable shaking, loss of balance, total body discomfort, inability to sleep or do daily tasks... Read more
Uncontrollable shaking, loss of balance, total body discomfort, inability to sleep or do daily tasks, total feeling of absolute sickness so severe that I thought I was going to die. This lasted for 2 days from April 17 thru April 19, 2021
71 2021-04-21 loss of personal independence in daily activities 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 sleep disorder, anxiety 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 2021-04-25 depression, depression Intense feeling so DEEP depression. Unable to shake. This lasted into the next day.
71 2021-04-26 disorientation 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 2021-04-26 sleep disorder The injection site got very red, hot and angry. It was very sensitive to touch, waking me up often ... Read more
The injection site got very red, hot and angry. It was very sensitive to touch, waking me up often since I sleep on my left side. I iced the site for a day or two. As I recall, starting a couple of days later I had terrible diarrhea and slept a lot for several days.
71 2021-04-27 confusional state Muscle Aches, R arm swelling, Fever to 103, few hours of confusion
71 2021-04-27 feeling abnormal wheezy cough, short of breath, hands and head were itchy, throat felt fat, episode of dizziness on... Read more
wheezy cough, short of breath, hands and head were itchy, throat felt fat, episode of dizziness on way to ER iv steriods, pepcid, and benadryl monitor in ER 3 hrs. continued prednisone, benadryl and pepcid for 5 days 03/04/2021 nausea, headache, feeling of in a fog for 24 hrs.
71 2021-04-27 excessive sleepiness CEDV chronic (Epstein–Barr virus) underlying condition it made; muscle weakness specially in face/f... Read more
CEDV chronic (Epstein–Barr virus) underlying condition it made; muscle weakness specially in face/feet that lasted for 10 weeks; very severe fatigue lasted for 10 weeks/very severe fatigue; haven't received the 2nd shot more than 36 days; She slept for 3 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPSTEIN-BARR VIRUS INFECTION REACTIVATION (CEDV chronic (Epstein–Barr virus) underlying condition it made) 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. Concurrent medical conditions included Epstein-Barr virus infection (CEDV chronic (Epstein–Barr virus)), Allergy to chemicals NOS (Chemical allergy. For which is she is taking phenobarbital and TB tine.) and Guillain Barre syndrome. Concomitant products included PHENOBARBITAL and TUBERCULIN PPD (TUBERSOL) for Allergy to chemicals. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HYPERSOMNIA (She slept for 3 days) and PRODUCT DOSE OMISSION ISSUE (haven't received the 2nd shot more than 36 days). On 15-Feb-2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness specially in face/feet that lasted for 10 weeks) and FATIGUE (very severe fatigue lasted for 10 weeks/very severe fatigue). On an unknown date, the patient experienced EPSTEIN-BARR VIRUS INFECTION REACTIVATION (CEDV chronic (Epstein–Barr virus) underlying condition it made) (seriousness criterion medically significant). On 11-Feb-2021, PRODUCT DOSE OMISSION ISSUE (haven't received the 2nd shot more than 36 days) had resolved. At the time of the report, EPSTEIN-BARR VIRUS INFECTION REACTIVATION (CEDV chronic (Epstein–Barr virus) underlying condition it made) and HYPERSOMNIA (She slept for 3 days) outcome was unknown and MUSCULAR WEAKNESS (muscle weakness specially in face/feet that lasted for 10 weeks) and FATIGUE (very severe fatigue lasted for 10 weeks/very severe fatigue) had resolved. 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 the events, a causal relationship cannot be excluded. However, this patient's underlying medical condition remains 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, this patient's underlying medical condition remains a confounder.
71 2021-04-27 sleep disorder Intense and constant headache, pain is concentrated just by the lower back of the skull and she desc... Read more
Intense and constant headache, pain is concentrated just by the lower back of the skull and she described it like a hammer hitting her head all day. The pain tends to migrate to the upper side to the neck. The pain is affecting her sleeping pattern, such as the heavy medicación she needs to Take is not enought to keep her sleep constinusly during the night.
71 2021-04-30 feeling abnormal Sick to my stomach, fever, headache, muscle ache, extremely tired, foggy head, itchy eyelids, later ... Read more
Sick to my stomach, fever, headache, muscle ache, extremely tired, foggy head, itchy eyelids, later on swollen & red eyelids, rosacea pustules on my nose. This happened both times as well as with Covid, only Covid was more extreme. Now finally I feel like myself again after 3 months of heck.
71 2021-05-02 mental impairment, confusional state The patient said she "had mental problems." She didn't know who she was or where she was for about ... Read more
The patient said she "had mental problems." She didn't know who she was or where she was for about a day and a half.
71 2021-05-03 feeling abnormal approximately 3 weeks 21 days after the first shot I developed a rash on my left thigh, knee and b... Read more
approximately 3 weeks 21 days after the first shot I developed a rash on my left thigh, knee and buttocks. it looked like red pimples or measles.....extremely painful and itchy.....red....bled when I scratched ..awfully uncomfortable....only now is the rash subsiding with using over the counter cortizone cream...it took me this long to link the vaccine to the rash....
71 2021-05-04 anxiety 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 feeling abnormal 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 insomnia Started 2/6/21 at approximately 8pm and lasted for 5 days: Extreme weekness, light headed, nausea, ... Read more
Started 2/6/21 at approximately 8pm and lasted for 5 days: Extreme weekness, light headed, nausea, migrains, burning in eyes, chills, rampted up back pain, extreme pain in left arm, unable to sleep.
71 2021-05-10 panic reaction patient's care giver reports that patient is talking non sense and behaving like panic. no other sym... Read more
patient's care giver reports that patient is talking non sense and behaving like panic. no other symptoms reported. Patient is administered vaccine on 05/10/21 and showing symptoms on 05/11/21. Care giver is advised to contact primary care doctor and take Tylenol if any fever or pain.
71 2021-05-12 feeling abnormal, thinking abnormal, sleep disorder 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 2021-05-12 feeling abnormal, thinking abnormal 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 2021-05-13 feeling abnormal Arm pain, generalized weakness, nausea, fatigue, brain fog. Tx rest, otc analgesic. Outcome: pending... Read more
Arm pain, generalized weakness, nausea, fatigue, brain fog. Tx rest, otc analgesic. Outcome: pending.
71 2021-05-13 sleep disorder After second vaccine I experienced loud ringing in my right ear. Went to medical doctor who set up a... Read more
After second vaccine I experienced loud ringing in my right ear. Went to medical doctor who set up an appointment with an ENT doctor but it was going to be 6 weeks before I could see him. I was able to see a NP ENT sooner who scheduled an MRI . The MRI showed no problems. I couldn't sleep or eat because of the ringing so my medical doctor prescribed anti anxiety and a sleeping pill. I still have ringing in my ear but not as loud.
71 2021-05-14 excessive sleepiness This spontaneous case was reported by an other health care professional (subsequently medically conf... Read more
This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEHYDRATION (Severe Dehydration) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) 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. The patient's past medical history included Alcohol use in 1966, Tobacco user in 1968, Dehydration (sever dehydration) in September 2019, Hypertension (severe hypertension) and Cataract operation (Bilateral cataract surgery). Concurrent medical conditions included Rheumatoid arthritis, High cholesterol, Prediabetes (Prediabetes type 2), Antidepressant therapy (Anti-depressant use) and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), BUPROPION and DULOXETINE HYDROCHLORIDE (CYMBALTA) for Depression, PRAVASTATIN for High cholesterol, HYDROCHLOROTHIAZIDE and LOSARTAN for Hypertension, HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) and PREDNISONE for Rheumatoid arthritis, METFORMIN for Type 2 diabetes mellitus. On 10-Oct-2019, the patient started ADALIMUMAB (HUMIRA) (unknown route) Citrate Free (40 mg,1 in 1 wk). 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 27-Feb-2021, the patient experienced HYPERSOMNIA (Sleep a lot than usual) and HEADACHE (Headache). On 01-Mar-2021, the patient experienced DEHYDRATION (Severe Dehydration) (seriousness criterion hospitalization prolonged). In March 2021, the patient experienced AGE-RELATED MACULAR DEGENERATION (WORSENED AGE RELATED MACULAR DEGENERATION). On an unknown date, the patient experienced HYPOPHAGIA (did not eat or drink). The patient was hospitalized from 03-Mar-2021 to 06-Mar-2021 due to DEHYDRATION. On 01-Mar-2021, HYPERSOMNIA (Sleep a lot than usual) and HEADACHE (Headache) had resolved. On 04-Mar-2021, DEHYDRATION (Severe Dehydration) had resolved. At the time of the report, HYPOPHAGIA (did not eat or drink) outcome was unknown and AGE-RELATED MACULAR DEGENERATION (WORSENED AGE RELATED MACULAR DEGENERATION) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: normal. In March 2021, Computerised tomogram: no significant findings No significant findings. In March 2021, Urine analysis: no significant findings No significant findings. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DEHYDRATION (Severe Dehydration) and HEADACHE (Headache) to be probably related, HYPERSOMNIA (Sleep a lot than usual) to be possibly related and AGE-RELATED MACULAR DEGENERATION (WORSENED AGE RELATED MACULAR DEGENERATION) to be not related. No further causality assessment was provided for HYPOPHAGIA (did not eat or drink). The patient was treated with (TYLENOL). action taken with mRNA-1273 not applicable Based on the current available information and temporal association between the use of the product and the start date of the events (hypophagia, headache, hypersomnia and dehydration), a causal relationship cannot be excluded. This case was linked to MOD-2021-108431 (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 (hypophagia, headache, hypersomnia and dehydration), a causal relationship cannot be excluded.
71 2021-05-22 feeling abnormal, mental impairment Approximately 3 hours after injection, I experienced explosive diarrhea. (That would be mid-afterno... Read more
Approximately 3 hours after injection, I experienced explosive diarrhea. (That would be mid-afternoon). That evening, I experienced ?brain fog? and lack of clarity. Have had headache every day since vaccination.
71 2021-05-23 anxiety 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 feeling abnormal 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 2021-05-26 excessive sleepiness 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 2021-05-26 sleep disorder 6 HOURS AFTER RECEIVING THE MODERNA SHOT,JOINTS ACHE, SEVERE DIARRHEA, FEVER OF 100. LACK OF SLEEP, ... Read more
6 HOURS AFTER RECEIVING THE MODERNA SHOT,JOINTS ACHE, SEVERE DIARRHEA, FEVER OF 100. LACK OF SLEEP, SEVERE HEADACHES, LACK OF ENGERY. THIS HAS NOT STOPPED SINCE ITOOK THE SHOT.
71 2021-05-27 confusional state 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 2021-06-02 feeling abnormal Very tired 3hrs after vaccine shot on 6/1/21. Fever 100.5 approx 16hrs after vaccine on 6/2/21. Feve... Read more
Very tired 3hrs after vaccine shot on 6/1/21. Fever 100.5 approx 16hrs after vaccine on 6/2/21. Fever 101.9 approx 18hrs after vaccine 6/2/21. Took ibuprofen. Fever hovered at 100+ to 101+ & occasionally spiking to 102+ 6/2/21. Fever broke approx 4am (approx 41hrs after vaccine shot) 6/3/21. 6/2/21 - fever, headache, L arm, shoulder, neck & shoulder blade pain, full body muscle pain & weakness. Pain was barely relieved by ibuprofen. Weakness , pain & feeling miserable don?t even begin to describe how badly I felt!! 6/3/21 - very painful arm, shoulder, neck, shoulder blade. Weak. 99,9 temp with ibuprofen.
71 2021-06-07 sleep disorder Immediately I could taste the vaccine and my arm is sore, I couldn't sleep, I woke up at 2am with se... Read more
Immediately I could taste the vaccine and my arm is sore, I couldn't sleep, I woke up at 2am with severe pain and vomiting. I did more dry heaving than throwing up. The next day I had a fever of 99.9, and I couldn't eat then diarrhea started and lasted a couple weeks along with headaches. I just don't feel good and haven't but don't know if it's vaccine related.
71 2021-06-08 loss of personal independence in daily activities At her last visit April 6 she reported a six-month deterioration in ability to walk, weakness, while... Read more
At her last visit April 6 she reported a six-month deterioration in ability to walk, weakness, while being treated for several infections then after the Covid 19 vaccination, her strength and balance has not returned to baseline. She now uses a walker at all times, previously used a cane, requires assistance cleaning at home, previously was independent. No clear flares prior to this.
71 2021-06-09 thinking abnormal Having Fever, headache, for 5 weeks, joints hurting, she is constantly tired and allergies are bad, ... Read more
Having Fever, headache, for 5 weeks, joints hurting, she is constantly tired and allergies are bad, all old injuries are coming back and said her bones and joints are flaring up. GI issues, difficult to eat, loss taste and smell, her whole general demeanor is affected, speech and thoughts are unclear, she is bruising easily and has rashes, under her arm in the cracks of her arms, and numbness in her fingers
71 2021-06-13 sleep disorder, abnormal dreams Headaches, Crazy Dreams, not able to sleep for weeks
71 2021-06-16 loss of personal independence in daily activities It started within a few days, it was a severe relapse of my chronic fatigue. I barely could make it ... Read more
It started within a few days, it was a severe relapse of my chronic fatigue. I barely could make it to the couch to watch TV. This lasted for a whole month. I was not able to function, manage my food preparation.
71 2021-06-17 anxiety, amnesia, feeling abnormal, depression, confusional state Upon the second injection, a hot, metallic taste came into my mouth immediately during the injection... Read more
Upon the second injection, a hot, metallic taste came into my mouth immediately during the injection. That evening, I became lightheaded, experienced chills, bone throbbing, and muscle pain. Since then, all of my autoimmune and chronic symptoms have worsened: bone pain, extreme fatigue, "empty-brain (brain fog)," loss of balance, coordination, and short-term memory, extreme mental confusion, worsening of depression and anxiety, and heightened allergic reactions.
71 2021-06-17 confusional state 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 confusional state Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Inje... Read more
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Abdominal Pain-Medium, Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Systemic: Headache-Medium
71 2021-06-20 mental status changes 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 2021-06-21 sleep disorder I woke up in the middle of the night extremely dizzy and very nauseous. I barely could walk to the b... Read more
I woke up in the middle of the night extremely dizzy and very nauseous. I barely could walk to the bathroom. I threw up. In the morning, I was dizzy and continued to vomit. Around noon, I went to Urgent Care. I was diagnosed with Vertigo. The doctor gave me a prescription medicine to take.
71 2021-06-22 sleep disorder Eight days after first vaccine, I was awakened early in the morning by loud, high-pitched ringing i... Read more
Eight days after first vaccine, I was awakened early in the morning by loud, high-pitched ringing in both ears. I'd had slight tinnitus for about 3 years, but this was many times greater. I had not heard about this as a possible side effect from the vaccine, so it was not an imagined side effect. I became very afraid, but could not get an appointee with an ENT doctor for over 2.5 months. It is tomorrow. Because of fear, I have not had my second vaccine.
71 2021-06-23 insomnia 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 2021-06-27 disturbance in attention fever fatigue weakness lasted a day, got very ill 1 month later, immobile arms and legs bad balance ... Read more
fever fatigue weakness lasted a day, got very ill 1 month later, immobile arms and legs bad balance bad concentration bad vision migraines, shingles
71 2021-06-28 confusional state 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 2021-06-28 depressed mood DAY FOLLOWING SHOT: SEVERE BONE AND MUSCLE PAIN, FEVER 102F, SHORTNESS OF BREATH, DIARRHEA, NAUSEA,... Read more
DAY FOLLOWING SHOT: SEVERE BONE AND MUSCLE PAIN, FEVER 102F, SHORTNESS OF BREATH, DIARRHEA, NAUSEA, VOMITTING, BLURRY VISION, DEPRESSED ATTITUDE SINCE SHOT.
71 2021-06-28 feeling abnormal Patient received her 2nd Moderna vaccine on 3/6/21; two weeks later on 3/20/21, patient woke up and ... Read more
Patient received her 2nd Moderna vaccine on 3/6/21; two weeks later on 3/20/21, patient woke up and felt nauseous for 1 hour that went away; no vomiting. On 6/21/21 at 1:30 pm, patient was standing at the kitchen counter when she started feeling "loose and weird in the head" as it is difficult to describe. This was then accompanied with "uncoordinated" movement in her lower legs. She walked over to the back porch, held on to the door while standing and called "help me" to her husband. Husband came over to help her sit and symptoms improved within 15 minutes. She states that is when her seizure happened and she was able to hold on to the door and did not fall - patient described this event as "violent." She felt continued to feel dizzy and got a headache but was able to track her husband's finger with her eyes which caused additional dizziness. She immediately went to the ER where she was diagnosed with dizziness and headache at the ER on 6/21/21.
71 2021-07-05 sleep disorder 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 2021-07-07 disturbance in attention, excessive sleepiness, amnesia Slept for 3 days straight. Followed by severe fatigue an was only able to stay awake for up to 2 ho... Read more
Slept for 3 days straight. Followed by severe fatigue an was only able to stay awake for up to 2 hours a day. Treatment was Vitamin D 50,000IU per week. Gradually resolving to this day still (present). Severe muscle weakness, especially in the face. Gradually progressed to other areas of my body, including my feet. Weakness has lessened but continues intermittently, especially when tired. No treatment. Currently have problems in forearms and legs falling asleep on me (numbness and tingling sensation). Happens during inactivity approximately every other day. Self massage and I move it around. Getting nodules on finger/hand joints with fluid collecting under the skin. Pain in my toes. Still affecting to the present time. No treatment. Neurological- very poor balance, considerable loss of short term memory, difficulty with focus and concentration,
71 2021-07-13 depression, insomnia diagnosed with Asymptomatic Cardiac Ischemia Pilot; has no energy; really depressed; trouble to slee... Read more
diagnosed with Asymptomatic Cardiac Ischemia Pilot; has no energy; really depressed; trouble to sleep; shortness of breath; whistle on her chest; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL ISCHAEMIA (diagnosed with Asymptomatic Cardiac Ischemia Pilot) in a 71-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. No Medical History information was reported. 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL ISCHAEMIA (diagnosed with Asymptomatic Cardiac Ischemia Pilot) (seriousness criteria hospitalization and medically significant), ASTHENIA (has no energy), DEPRESSION (really depressed), INSOMNIA (trouble to sleep), DYSPNOEA (shortness of breath) and WHEEZING (whistle on her chest). At the time of the report, MYOCARDIAL ISCHAEMIA (diagnosed with Asymptomatic Cardiac Ischemia Pilot), ASTHENIA (has no energy), DEPRESSION (really depressed), INSOMNIA (trouble to sleep), DYSPNOEA (shortness of breath) and WHEEZING (whistle on her chest) 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. Reportedly, the patient needs to get an implant device on her heart. Date of birth of patient given as 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 2021-07-17 delirium vomiting; Injection site redness; delirious; oral intake reduced; mobility decreased; sweating; feve... Read more
vomiting; Injection site redness; delirious; oral intake reduced; mobility decreased; sweating; fever; This spontaneous case was reported by a physician and describes the occurrence of DELIRIUM (delirious) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. The patient's past medical history included Smoker (Former cigarette smoker) from 1970 to 1996. Concurrent medical conditions included Shellfish allergy (Hives), Allergy to antibiotic (Doxycycline- skin eruption) and Rheumatoid arthritis. Concomitant products included RISEDRONATE SODIUM (RISEDRONATE) for Bone disorder NOS, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Pain. In November 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 12-Mar-2021, the patient experienced DELIRIUM (delirious) (seriousness criterion medically significant), HYPOPHAGIA (oral intake reduced), MOBILITY DECREASED (mobility decreased), HYPERHIDROSIS (sweating), PYREXIA (fever) and INJECTION SITE ERYTHEMA (Injection site redness). On 14-Mar-2021, the patient experienced VOMITING (vomiting). On 14-Mar-2021, DELIRIUM (delirious), HYPOPHAGIA (oral intake reduced), MOBILITY DECREASED (mobility decreased), HYPERHIDROSIS (sweating), PYREXIA (fever), VOMITING (vomiting) and INJECTION SITE ERYTHEMA (Injection site redness) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not reported.; 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 2021-07-17 feeling abnormal in the bed for four days; diarrhea for the night; did not want to move; felt bad; fell while trying ... Read more
in the bed for four days; diarrhea for the night; did not want to move; felt bad; fell while trying to take two or three steps; hip was hurt when she fell; left foot was not working right; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (in the bed for four days) and FALL (fell while trying to take two or three steps) 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. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis. The patient's past medical history included Fall, Skin indentation, Bladder incontinence and Hip surgery. Concurrent medical conditions included Hand pain. 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. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 21-Jun-2021, the patient experienced FALL (fell while trying to take two or three steps) (seriousness criterion medically significant), MUSCULOSKELETAL DISORDER (left foot was not working right) and JOINT INJURY (hip was hurt when she fell). On an unknown date, the patient experienced BEDRIDDEN (in the bed for four days) (seriousness criterion medically significant), FEELING ABNORMAL (felt bad), MOBILITY DECREASED (did not want to move) and DIARRHOEA (diarrhea for the night). At the time of the report, BEDRIDDEN (in the bed for four days), FALL (fell while trying to take two or three steps), FEELING ABNORMAL (felt bad), MOBILITY DECREASED (did not want to move), DIARRHOEA (diarrhea for the night), MUSCULOSKELETAL DISORDER (left foot was not working right) and JOINT INJURY (hip was hurt when she fell) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine), the causality assessment by the reporter for the events Feeling abnormal, Mobility decreased and Diarrhea were possible. For rest of the events, the reporter did not provide any causality assessments with respect to mRNA-1273 (Moderna COVID-19 Vaccine). Concomitant medication of the patient was not reported. No treatment information was provided. Before the pandemic started the patient had hip surgery as she had a falling accident. She had to go to the emergency room via ambulance she had a dent in her leg as the physician had to a bone out. She had bladder control issues and lately she had to wear diapers. The palm of right hand was hurting her right at the time of report. Company comment: Very limited information regarding this event has been provided at this time. Critical information including the date of vaccine administration, onset date for the events, treatment administered, and outcome are required for further assessment.; Sender's Comments: Very limited information regarding this event has been provided at this time. Critical information including the date of vaccine administration, onset date for the events, treatment administered, and outcome are required for further assessment.
71 2021-07-17 feeling abnormal Feel horrible; Fatigue like I've never had; cannot drive; viral count was active and very high.; vit... Read more
Feel horrible; Fatigue like I've never had; cannot drive; viral count was active and very high.; vitamin D deficiency; fell asleep while driving; couldn't get out of bed/felt sick; pains; fever; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL TITRE INCREASED (viral count was active and very high.), IMPAIRED DRIVING ABILITY (cannot drive) and SOMNOLENCE (fell asleep while driving) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0392KKOA and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Epstein-Barr virus infection. Concurrent medical conditions included Rheumatoid arthritis and Immunocompromised. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-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 VACCINATION COMPLICATION (couldn't get out of bed/felt sick), PAIN (pains), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches). In April 2021, the patient experienced SOMNOLENCE (fell asleep while driving) (seriousness criterion medically significant). On 21-May-2021, the patient experienced VIRAL TITRE INCREASED (viral count was active and very high.) (seriousness criterion medically significant) and VITAMIN D DEFICIENCY (vitamin D deficiency). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (cannot drive) (seriousness criterion disability), FEELING ABNORMAL (Feel horrible) and FATIGUE (Fatigue like I've never had). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) ongoing since an unknown date at a dose of 1 dosage form and COLECALCIFEROL (VITAMIN D 3) ongoing since an unknown date for Vitamin D deficiency, at an unspecified dose and frequency. On 16-Feb-2021, VACCINATION COMPLICATION (couldn't get out of bed/felt sick), PAIN (pains), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle aches) had resolved. At the time of the report, VIRAL TITRE INCREASED (viral count was active and very high.) and IMPAIRED DRIVING ABILITY (cannot drive) had not resolved and SOMNOLENCE (fell asleep while driving), VITAMIN D DEFICIENCY (vitamin D deficiency), FEELING ABNORMAL (Feel horrible) and FATIGUE (Fatigue like I've never had) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Blood immunoglobulin M: normal (normal) Normal. On 21-May-2021, Epstein-Barr virus test: positive (Positive) Positive. On 21-May-2021, Full blood count: normal (normal) The result were ok.. On 21-May-2021, Metabolic function test: normal (normal) The result were ok. Concomitant product use was not provided by the reporter. The patient took diet and had fluids for the events and checked her blood pressure, heart rate, and temperature every day. She discussed her symptoms and results with a neurologist, ENT (ear, nose, and throat physician), and her primary care physician. She is following up next with her ENT (ear nose and throat physician) on 27-Aug-2021. She is on Anti-viral medication and it was very expensive. Based on the current 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-2021-235765 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Added new event pain in extremity. Additional information was updated in narrative; 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 2021-07-18 impaired work ability Headache - severe; general malaise - not feeling well; itching and burning - red, angry rash started... Read more
Headache - severe; general malaise - not feeling well; itching and burning - red, angry rash started on left arm. And also over part of my chest. I called the doctor and the doctor (virtual appt and email) gave me stronger medication - Hydroxyzine HCL 25 mg - four times a day and the same cream as last time Triamcinolone Acetonide 0.025%. They helped calm it a little bit. I had the headache two days. I was not able to work. I had the itching and burning symptoms for two weeks. I had another outbreak of herpes symptoms - I have used Valtrex for since 1998 - and that had been keeping the herpes symptoms away - and now I am having herpes outbreaks again but not as severe as it has been those years back. I continue on the Valtrex.
71 2021-07-25 feeling abnormal, sleep disorder 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 2021-07-27 crying, feeling abnormal Body aches, headaches, nausea lasting 30-40 hours. Fatigue, weakness, feeling run down ongoing sinc... Read more
Body aches, headaches, nausea lasting 30-40 hours. Fatigue, weakness, feeling run down ongoing since time of initial dose of vaccine
72 2021-01-07 feeling abnormal Woke up at 3 am, temperature of 99.6, body aches, joint pain, brain fog and fatigue. Starting takin... Read more
Woke up at 3 am, temperature of 99.6, body aches, joint pain, brain fog and fatigue. Starting taking Advil and Tylenol every six hours. No respiratory issues.
72 2021-01-10 feeling abnormal Received vaccine at 1:06pm. At 3:30pm felt something odd in my mouth. Looked and found left front si... Read more
Received vaccine at 1:06pm. At 3:30pm felt something odd in my mouth. Looked and found left front side of my tongue was reddened and raw looking, no discomfort at all. Kept watching for last couple of days and today it seems alittle better but my doctor felt it should be reported. I do have a picture
72 2021-01-13 feeling abnormal 4 days after the injection, I felt weary when I woke up that morning. By 10:00 AM, I had a moderate... Read more
4 days after the injection, I felt weary when I woke up that morning. By 10:00 AM, I had a moderate headache that lasted the rest of the day even though I did take some Ibuprofen. 5 days after, I was extremely fatigued but able to go to work and do my daily activities but went to sleep soon after dinner. 6 days after was a repeat of the extreme fatigue but I did get through my day and went to sleep early. Day 7, I woke up feeling great and have not had any other symptoms.
72 2021-01-17 excessive sleepiness I got the shot and i was ok the first day but the next day I felt groggy and week. I went and had br... Read more
I got the shot and i was ok the first day but the next day I felt groggy and week. I went and had breakfast and then i got the chills, then i started sitting up but i felt awful so i went back to bed and dizziness weakness headache, redness around injection site. My whole left side felt like it was achy and almost like it was numb. I lost bladder control, I had a couple of accidents. I stayed in bed until next day, couldn't get out of bed, couldn't eat. Got up Saturday, not feeling good, queasy, diarrhea but not as bad as Friday. Every time i would try to do something i would fall asleep. went and had covid test for surgery. Sunday I felt better but not to par. Today i feel the best so far. Put antibiotic cream on injection site because it was itching, and it is still hard and warm to touch. Today i have a small cough that I didn't have before.
72 2021-01-21 feeling abnormal Headache, more intense over the last few days, still has it, loss of appetite, brain fog. Couldn't ... Read more
Headache, more intense over the last few days, still has it, loss of appetite, brain fog. Couldn't answer simple questions, extreme fatigue, bowel changes, diarrhea. Still experiencing all symptoms except brain fog. no fever.
72 2021-01-21 sleep disorder The patient initially had a large area of erythema and swelling the day following the vaccine which ... Read more
The patient initially had a large area of erythema and swelling the day following the vaccine which improved but did not fully resolve. Then 7 days after the vaccine, she experienced severe pruritis that actually woke her from sleep and had been scratching the area. It has now on day 8 become much more indurated and has grown in size, even during today.
72 2021-01-27 restlessness Intermittent feelings of unrest, chest tightening, and heaviness in arms
72 2021-01-28 excessive sleepiness I was cold and then I started getting chills and all I wanted to do was sleep. I didn't want to eat ... Read more
I was cold and then I started getting chills and all I wanted to do was sleep. I didn't want to eat just go to sleep. So today my legs are sore.
72 2021-01-29 feeling abnormal 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 2021-01-30 excessive sleepiness Shot hurt alot when given. Entire upper arm very sore for two days. Thurs. morning at 6:50am bitter ... Read more
Shot hurt alot when given. Entire upper arm very sore for two days. Thurs. morning at 6:50am bitter taste in my mouth for two days. Thurs. slept on and off all day. Very unlike me. Dizzy had to be very careful when I did go back to bed.. I did put an ice pack on my arm but it did not seem to help to relive the pain. Shot given to high on my arm. I did not go to a dr. I had no one to drive me.
72 2021-01-31 altered state of consciousness, confusional state 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 feeling abnormal Patient presented in this office for regular Chiropractic care. Patient stated she experienced ?exc... Read more
Patient presented in this office for regular Chiropractic care. Patient stated she experienced ?excessive fatigue? on Tuesday 1/26/21 and it ?really hit? Thursday 1/28/21. Reported she slept 15 hrs from 6:30pm to 9:30 am on the 29th. Excessive fatigue continued on the 29th and the 30th averaging 12-14 hours of sleep per night. Patient reported she felt pressure in the head with brain fog to the point that she didn?t trust herself to safely prepare meals. No appetite due to fatigue and mild nausea. Report O2 was ?a little low? but didn?t quantify. Woke Sunday am 1/31/21 and felt ?more normal?. During Chiropractic treatment patient stated it felt like her brain had went through a trauma.
72 2021-01-31 feeling abnormal 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 2021-02-02 sleep disorder Unable to left arm beginning within 2.5 hours after injection. Continued deltoid discomfort and poor... Read more
Unable to left arm beginning within 2.5 hours after injection. Continued deltoid discomfort and poor sleeping. Continued symptoms to date 02-03-2021
72 2021-02-03 feeling abnormal 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 2021-02-03 excessive sleepiness 10 days after vaccination, injection site became itchy, red, swollen and hard. 7.5cm x 5cm. Headach... Read more
10 days after vaccination, injection site became itchy, red, swollen and hard. 7.5cm x 5cm. Headache and slept most of the time for the next 4 days.
72 2021-02-04 insomnia, anxiety 1/22/21 - right after shot-headache, lightheaded, fatigue, muscle weakness, chills, joint and muscle... Read more
1/22/21 - right after shot-headache, lightheaded, fatigue, muscle weakness, chills, joint and muscle aches, chills, nasal congestion, pain at shot site. Except for pain at shot site, lasted 24 hours 2/1/21- Developed feeling of anxiety, muscle spasms in arms and legs, sleeplessness, headache, lightheaded, joint and muscle pain, chills, sweats, continued pain in arm, itching, nasal congestion, low blood sugar. Symptoms began receding on second day with only itching and nasal congestion today 2/5 In the past, I have had similar reactions to some antibiotics, otc/herbal meds, flu shots. Was told by Allergist that these were not allergic reactions but side effects.
72 2021-02-07 anxiety Dizzy, anxious, and flushed after the vaccine. BP 160/93, pulse 86; repeat BP 157/90 (pulse 84); O2 ... Read more
Dizzy, anxious, and flushed after the vaccine. BP 160/93, pulse 86; repeat BP 157/90 (pulse 84); O2 sat 98%-100%. Improved with water.
72 2021-02-07 sleep disorder Itching at site woke me up early morning. Later in afternoon my cheeks became bright red with a temp... Read more
Itching at site woke me up early morning. Later in afternoon my cheeks became bright red with a temp. A little sluggish, cold but slept good and woke up next morning feeling good.
72 2021-02-08 delirium 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 2021-02-08 sleep disorder I was fine for the first twelve hours and then I had extreme arm pain, all the way down my entire ar... Read more
I was fine for the first twelve hours and then I had extreme arm pain, all the way down my entire arm, and expanded through my whole body. I had extreme body aches, and headaches. Joint pain was very bad. Took Tylenol, but that didn't help, and I iced my arm but that also did not help. I was not able to to sleep all night. Fevers, chills, and fatigued. Right arm is still pretty red and hot to the touch.
72 2021-02-10 abnormal behaviour 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 hallucination, confusional state confusion, lethargic, fever, swollen arm, numbness from waist to knee's, purple face, veins in legs ... Read more
confusion, lethargic, fever, swollen arm, numbness from waist to knee's, purple face, veins in legs hurting, hallucinations
72 2021-02-12 feeling abnormal flu like symptoms the day following the second vaccine. fatigue, muscles soreness, general bad feel... Read more
flu like symptoms the day following the second vaccine. fatigue, muscles soreness, general bad feeling two days at current time, getting better
72 2021-02-13 sleep disorder, feeling abnormal 12:30 a.m. Chills/sweating back and forth, began to hurt all over.....shoulders, back, hips, hip bur... Read more
12:30 a.m. Chills/sweating back and forth, began to hurt all over.....shoulders, back, hips, hip bursa, knee, ankles, and injection site began to ache. Increased during night, with NO sleep! Headache and fever arrived. Entire day aching increased (Extra Strength Tylenol really didn't help). Appetite minimal. Plenty of water! Aching injection site so bad could barely lift the arm. Fever 100.6 gone by following morning and felt stiff all over. Day 5, still feel light-headed and unsettled. Notified doctor by Portal message of reaction (knowing it wasn't life-threatening and common). Doc's reply it was common. But this took a healthy, active old lady with NO conditions to a general very ill level.
72 2021-02-14 feeling abnormal Light head mess and dizziness off and on but mild. Not having them now. Itchy arm immediately and ... Read more
Light head mess and dizziness off and on but mild. Not having them now. Itchy arm immediately and day #2 red hot swollen and a small knot today I measured it at 2 inches in Diameter. It?s a tad better today. Very sore. And kind of a rash there but the rash is getting lighter. I have soreness throughout my body but mostly my right arm I am having spells of light nausea come and go. I didn?t have a headache but stiff neck and it?s starting to get better. But I just had a strange sensation for the first Three days in my forehead and didn?t hurt but annoying and it is not as noticeable today so maybe it is going away. No fever or anything else like flu none of that My arm at the site is still warm today. I am feeling ok other than that.
72 2021-02-14 loss of personal independence in daily activities 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 2021-02-15 hallucination About 5 minutes after receiving the vaccine, described seeing a dog in the corner of the room - a ha... Read more
About 5 minutes after receiving the vaccine, described seeing a dog in the corner of the room - a hallucination. She then said she was feeling overall unwell. Over the subsequent 30 minutes, she described a severe headache, nausea, itching, and had trouble answering basic questions. Paramedics were called, who conducted an evaluation, which noted dizziness, vision trouble and uneven arm weakness. Paramedics determined she needed further evaluation at a hospital, and was taken to Hospital.
72 2021-02-16 sleep disorder SEVERE muscle pain, burning sensation in chest cavity and espophagus, slight fever (1 degree), fatig... Read more
SEVERE muscle pain, burning sensation in chest cavity and espophagus, slight fever (1 degree), fatigue, headache. These were the most severe manifestations I have ever experienced. Since I have previously had anaphylaxis, I am more worried about the reactions. I was not able yo sleep at all due to the strong pain. I do feel better this morning, but nowhere near ok.
72 2021-02-17 sleep disorder My question is to find out if this could be a side effect of getting the vaccine or not?It seems to ... Read more
My question is to find out if this could be a side effect of getting the vaccine or not?It seems to be persistent though each day less in pain as long as I use Tumeric. Pain under Left Shoulder Blade radiates to Left Arm outter under muscle / roves to wrists / roves to shoulder muscle by neck. Comes and goes during the day. Wakes me up at night. Initally it was severe pain subsiding to an ache still roving never stationary. I manage it with Supplements of Tumeric.
72 2021-02-18 feeling abnormal, restlessness, insomnia I received the vaccine at 3pm, went home and arm started hurting but not bad. Started getting very ... Read more
I received the vaccine at 3pm, went home and arm started hurting but not bad. Started getting very restless while trying sleep, developed a bad headache and muscle aches and pains during night around 4-5am. Kept getting worse, by 8:30 am had chills, lethargy and generalized weakness. Felt as bad as when I had COVID 60 days prior. Husband and I both had COVID then and he also got very sick after shot with same symptoms but low grade temperature of 100.5. Our symptoms lasted into next day and evening. Finally feeling some better by midnight. I had good day on 3rd day and then that night very restless and couldn?t sleep. Wiped out all day. Brain very foggy, achy and just not feeling well. Fifth day just seem to tire easily and wanting to nap which I don?t usually do.
72 2021-02-18 feeling abnormal 02/10/2021 approx 7 min post vaccination client had an 'odd sensation' in her neck, tender, has neve... Read more
02/10/2021 approx 7 min post vaccination client had an 'odd sensation' in her neck, tender, has never experienced this before. Left after 30" not worsening of s/s, 3PM still feeling odd neck sensation. Took Benadryl, called her PCP-, at 5PM called MD again, felt some tingling 'felt weird', neck sensation still there, went into office to see MD. Pt stated she still has neck sensations at this time. Pt was notified her daughter and family all tested positive for COVID, s/s started on 2/8, Pt last had 'not so close' contact w/ her daughter on 2/7, within the 48' infectious window period. Pt had negative vault test done on 2/11, approx 4 days post exposure. Instruct Pt to retest tomorrow. Pt states she kept Additional information for Item 18: kept wondering if maybe her neck sensations were related to the virus. Pt referred back to PCP re getting the 2nd vaccine dose, due 3/10. Staff told Pt if recommended to get the 2nd dose that we would want her to have it done at the hospital in case she has same/worse reaction.
72 2021-02-18 sleep disorder low-grade fever, severe arm pain that woke patient from sleep, headache. patient took tylenol which ... Read more
low-grade fever, severe arm pain that woke patient from sleep, headache. patient took tylenol which helped to resolve symptoms.
72 2021-02-20 fear, feeling abnormal Approx 2 1/2 hours after my first vaccination I was sitting watching TV and got a very sudden and ve... Read more
Approx 2 1/2 hours after my first vaccination I was sitting watching TV and got a very sudden and very intense metal taste in my mouth. I waited about 2 minutes to see if it would go away abd then got up to go get a drink of water to try to make the taste go away. As soon as I stood I nearly fell abd felt I was about to pass out. I told my husband I was not OK abd went a few feet out my front door to an outside chair for more air. I felt extremely lightheaded. After maybe 5 minutes the metal taste went away abd I felt a little less light headed. I went back inside abd sat again but almost instantly the metal taste came back. I sat outside until the metal taste went away again. My husband brought me water to drink. The light headed ness eased up but didn?t go away until 4 PM that afternoon. It was a terrifying feeling. I emailed my doctor mg d also called ER to see if I should go to the hospital. I had an online appointment with an ER doctor who had not heard about those side effects before abd was only interested in whether I was having trouble breathing. I was not having trouble breathing. My Dr. emailed back stating I should go for my second shot, which I have not had yet, and take Benedryl. I?m scared about having these side effects again. I nearly passed out and if the second one is worse as I?ve heard I just don?t know if I should have it.
72 2021-02-20 sleep disorder I am reporting this as I have had a problem with the second vaccination. The first vaccination was ... Read more
I am reporting this as I have had a problem with the second vaccination. The first vaccination was a breeze. I was part of the CDC follow up. There isn?t a follow up with the second vaccination. I believe there should be instead of just asking if you received the second vaccination. Even though it started with some pain at the site of injection it progressed in severity causing a sleepless night. During the night, chills and nausea. No fever. The following day (2/20/2021) I was in bed or on the sofa all day. Slept a lot. Didn?t want to eat. Today (2/21) I?m 95% back to normal with just slight discomfort at the injection site.
72 2021-02-21 impaired work ability Received #1 dose as stated. Next day, 1/27/21, 9:00am , had mild joint pain to both legs, & arms, &... Read more
Received #1 dose as stated. Next day, 1/27/21, 9:00am , had mild joint pain to both legs, & arms, & slightly tired. Shortly after that , while driving, had nausea, & muscle aches to legs & arms. Reaching family members home, could barely carry bags with each arm, due to pain in joints, and to muscles, getting worse. Through the next 6 hrs. had moderate to severe pain to joints, & muscles & gradually severe fatigue. Took 1 Tylenol 650 mg for pain. Also, checked temperature thru out this time, with only mild 99.5 temp. Vaccine site gradually became swollen, with increased pain. Was doing work on computer, but could not continue, so left for my home, & went to bed, to sleep. Lt. Arm started becoming red, with severe soreness & swelling by 1/28/21, 2 days after vaccine. Vaccine was given very high on my arm, almost shoulder area. All Symptoms continued for about 10 days, including to vaccine arm, which continued with redness & soreness for 2 weeks. My physician was notified. She advised NSAID before #2 dose, but I already take NSAID daily (Meloxicam), so don't think I can take another NSAID. I have been taking Tylenol 650mg at least twice a day, for increased joint & muscle pain, since vaccine. My 2nd dose, originally scheduled for 2/23/21 has been rescheduled to 2/27/21 due to no vaccines available.
72 2021-02-21 nervousness 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 2021-02-22 feeling abnormal PT BEGAN TO C/O FEELING FUNNY AND DIZZY IMMEDIATELY FOLLOWING INJECTION. PT ALERT AND ORIENTED X 4, ... Read more
PT BEGAN TO C/O FEELING FUNNY AND DIZZY IMMEDIATELY FOLLOWING INJECTION. PT ALERT AND ORIENTED X 4, NO LOSS OF CONCIOUSNESS, BREATHING NORMAL, SKIN NATURALLY PALE, W/D WITH NO DIAPHORESIS. PT STATES SHE HAS NOT EATEN TODAY. TAKES BP MED AT 2PM. GAVE A PIECE OF MINT CANDY , OFFERED CRACKERS BUT DECLINED; SHE ALSO TOOK HER BP MED. OUTCOME: FELT BETTER AFTER 5 MINUTES, SHE STATES SHE THINKS IT WAS HER BLOOD SUGAR. CONTINUED TO MONITOR X 15 MINUTES WITH NO FURTHER INCIDENCE
72 2021-02-22 nervousness, fear Pt received her first dose of the Moderna COVID19 vaccine Oxygen Sat 95% HR 102 BP 190/90 BP rechec... Read more
Pt received her first dose of the Moderna COVID19 vaccine Oxygen Sat 95% HR 102 BP 190/90 BP recheck 10 minutes later 158/78 HR 78 Pt reported feeling ?queasy? and unwell about 10 minutes after vaccination. Pt was evaluated by Prospect EMS paramedic. Pt reported being very afraid and nervous that the vaccine implanted a micro chip in her and she is scared she is going to start ?.? Pt signed refusal for transport to the hospital with Prospect EMS. Pt reported feeling better.
72 2021-02-23 insomnia Pain at injection site, fatigue, headache, myalgia, very cold, nausea and vomiting, fever, had insom... Read more
Pain at injection site, fatigue, headache, myalgia, very cold, nausea and vomiting, fever, had insomnia, took Tylenol
72 2021-02-24 feeling abnormal I was perfectly fine after the vaccine, except for a sore arm. On day 3 I noticed my tongue starting... Read more
I was perfectly fine after the vaccine, except for a sore arm. On day 3 I noticed my tongue starting to swell and lips tingling. It got a little worse and I felt it moving towards my throat, and then it stopped. This only lasted maybe a couple of hours, and not more than three hours. I had not eaten anything since the day before, so knew it was not food related. I didn?t associate this reaction to the vaccine until I searched online, and found that tongue swelling and facial paralysis could be common. I was also tired that day. On day 4 I had none of those symptoms but was very tired and did not feel myself; little energy, somewhat lethargic.
72 2021-02-24 sleep disorder Severe headache, unable to sleep, elevated temperature in morning, muscle aches, arm soreness
72 2021-02-25 insomnia I can't move my arm/can't bring my arm up to my breast and obviously over my head/this really limits... Read more
I can't move my arm/can't bring my arm up to my breast and obviously over my head/this really limits my mobility; it was that upper joint area that was throbbing; couldn't sleep much because it was excruciating; extreme pain in my shoulder/excruciating pain in my shoulder/that top part, that ball and socket was excruciating to move; Vaccine given too high up in my arm/it felt like it was going into my bone at the top; Chills; my whole arm hurt/it's excruciating when I attempt to be mobile; A spontaneous report was received from a consumer (United States) concerning herself, a 72-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273), who experienced the following events: I'm concerned it was given too high up in my arm/it felt like it was going into m y bone at the top/MedDRA PT: inappropriate route of vaccination, that top part, that ball and socket was excruciating to move/MedDRA PT: joint pain, I can't move my arm/can't bring my arm up to my breast and obviously over my head/this really limits my mobility/MedDRA PT: injected limb mobility decreased, chills, my whole arm hurt/it's excruciating when I attempt to be mobile/MedDRA PT: pain in arm, couldn't sleep much because it was excruciating/MedDRA PT: sleep difficult, it was that upper joint area that was throbbing/MedDRA PT: throbbing pain, band ack to the same pain I had after the injection/MedDRA PT: shoulder pain. The patient's medical history included cancer and child birth x 2. Concomitant medication use was not provided. On 03 Feb 2021, the patient received the first of two planned doses of mRNA-1273 ([LOT 029L20A]) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Action taken with mRNA-1273 in response to the events was not reported. The even of "a couple of patients received their dose at 7 hours" was considered recovered/resolved (date unspecified).; Reporter's Comments: This case concerns a 72-year-old female who had NS unexpected Incorrect route of product administration and NS unexpected injected limb mobility decreased, painful arm, throbbing pain, insomnia and NS expected arthralgia, chills. The events occurred the same day as first dose of mRNA-1273. Treated with Tylenol. Events ongoing. 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.
72 2021-02-25 sensation of foreign body 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 2021-02-27 feeling abnormal, sleep disorder, nightmare I LEFT THE HEALTH DEPT CLINIC AFTER MY 2nd MODERNA DOSE AND WAS FINE ALL DAY. THEN AT 2;30 A.M. [... Read more
I LEFT THE HEALTH DEPT CLINIC AFTER MY 2nd MODERNA DOSE AND WAS FINE ALL DAY. THEN AT 2;30 A.M. [ 2-23-2021 ] I WAS STARTLED AWAKE LIKE A BAD DREAM WITH INTENSE BODY PAIN AND FEELING TERRIBLE. I TOOK ONE IBUPROPHEN 800 MG TAB AND A GLASS OF WATER AND WENT BACK TO BED. i FELT CRAPPY ALL DAY AND STAYED IN BED 2-23-2021. ON THE NEXT DAY I WAS BACK TO REGULAR ROUTINE.
72 2021-02-27 sleep disorder Terrible chills, up to 103 degree fever, body aches, inability to sleep. Fever subsided to about ... Read more
Terrible chills, up to 103 degree fever, body aches, inability to sleep. Fever subsided to about 100 after 2 tylenol. Total duration of chills about 5-6 hours, fever about 15-16 hours.
72 2021-03-01 sleep disorder I woke up at 11:30 pm with severe intestinal cramping. I have IBS so I used what normally worked - ... Read more
I woke up at 11:30 pm with severe intestinal cramping. I have IBS so I used what normally worked - heat and a dicyclomine capsule. It got worse and worse to the point my whole body was shaking. I felt nauseous and thought I might throw up from the pain (I didn't). At 1:00 am I took a 5mg Oxycodone pill. I got a little relieft at about 1:45 am. The spasms started coming in waves. At 3:15 am I took another dicyclomine and again used the heating pad. At about 4:30 am, I was able to fall asleep. This is absolutely the worst spasming I have ever had.
72 2021-03-02 restlessness 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 sleep disorder 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 2021-03-03 insomnia 2/28/21 10pm-10pm 3/1/21, Chills, fatigue and insomnea. Headache 2/28/21 8pm-10pm Acetaminophen 650 ... Read more
2/28/21 10pm-10pm 3/1/21, Chills, fatigue and insomnea. Headache 2/28/21 8pm-10pm Acetaminophen 650 mg. Fatigue. 3/2/21 Diarrhea, nausea, fatigue, abdominal discomfort, gas, Gas x and Imodium. Gatorade. 3/3/21 fatigue, gas, indigestion, lack of appetite. eating light, yogurt, soup, crackers, oatmeal, scrambled egg, toast.(3/1-3/3)
72 2021-03-04 anxiety 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 2021-03-04 nervousness pt states that after taking her 2nd dose of the covid vax she developed chills that day. Next day s... Read more
pt states that after taking her 2nd dose of the covid vax she developed chills that day. Next day she became very fatigued and could barely move. She stated her every muscle in her body hurt so bad that even the sheets on the bed hurt to touch her skin. She had a slight temp and started vomiting. She went to bed and slept for hours. Today 3/5/2021 she states her muscles are getting less sore and she is less shaky. Pt states she called her pharmacist but has not called her PCP since she is feeling some better today.
72 2021-03-05 sleep disorder first attempt to adminster vaccine at the top of shoulder, health care provider bent needle. the nee... Read more
first attempt to adminster vaccine at the top of shoulder, health care provider bent needle. the needle was replaced and the vaccine was injected at top of shoulder and collarbone. after injection, I went home awaken about 2:30am with pain in the intire left arm. I still have pain after one month. for about 10 days I could not use arm. I am now 85% pain free. I still can not lift arm above head I did not want my friends and family to know how servere my pain was for fear they would not want to get the vaccine. I have never had vaccine of any type in the area that this vaccine was injected. I did not go to doctor's office due to weather 14 inches of snow. however, I did make my primary physican aware of issue...
72 2021-03-06 amnesia, feeling abnormal ADVERSE EVENTS: Spouse was unable to get out of bed Legs were very weak (had to be helped up and e... Read more
ADVERSE EVENTS: Spouse was unable to get out of bed Legs were very weak (had to be helped up and even then very unsteady) Level of mental fog (limited recollection of events leading to her physical state at the time) TREATMENT: Visited primary physician the day after vaccine Spouse had a low grade fever and a blood panel was taken (results were inconclusive as to cause
72 2021-03-06 sleep disorder Right arm began itching on Saturday, March 6, 2021, which is 11 days after the COVID shot. During... Read more
Right arm began itching on Saturday, March 6, 2021, which is 11 days after the COVID shot. During the night of March 6, right shoulder and upper right arm ached most of the night making it very difficult to sleep. When I got up the morning of March 7, upper shoulder of right arm had a large red rash (about 4" in diameter) and another red rash (about 2" in diameter) was on my right arm just to the left of where the COVID shot was given. The rash was very itchy and my upper right arm felt warm. Applied hydrocortisone cream which slightly relieved the itching but not the redness.
72 2021-03-07 disorientation With 1st shot on 2/03/2021 I had a sore left arm for 4 days With 2nd shot given on 3/02/2021 I had ... Read more
With 1st shot on 2/03/2021 I had a sore left arm for 4 days With 2nd shot given on 3/02/2021 I had a severe headache which I woke up with the next day. Had headache all day. The next day when I awoke I know longer had headache but I felt disorientated through out the day. After that I have had know problems
72 2021-03-07 excessive sleepiness The following day at about 10:00 a.m. I began to feel weak, nauseated, extreme fatigue. By 3:00 p.m.... Read more
The following day at about 10:00 a.m. I began to feel weak, nauseated, extreme fatigue. By 3:00 p.m. I had to go to bedsit chills, very cold fever of 100. I remained in bed sleeping, being checked on by friend. During the night I continued to have chills and a fever up to 103.4. Sore bones feeling, chills fever. I slept until 7:00 a.m. the next morning and I was all better. No fever, a little ache in body. Slept 17 hours. No other issues after I slept 17 hours. Fever gone.
72 2021-03-07 loss of personal independence in daily activities, sleep disorder, feeling abnormal pt stated that starting about 1:30 after getting the vax she had nausea and severe pain in the right... Read more
pt stated that starting about 1:30 after getting the vax she had nausea and severe pain in the right arm which kept increasing in pain until she was unable to move her arm. That night her arm was in the 9-10 range for pain. She hasn't been able to sleep due to the pain. The next day she took Tylenol but did not help with pain. She had a strange taste in her mouth and also loss of appetite. On 3/6/2021 she started getting a back ache. She tried taking Ibuprofen which helped some with swelling in her arm but not the pain. On 3/7/2021 she started getting a headache, brain fog and saying her words backwards. She is very upset with the lack of warning that she was given at the time of the getting the first dose of the vax about being in this type of pain afterwards. She said she was not prepared for this. She has to have help doing everything and lives alone. Today the arm pain seems to slightly be improving but her back is still hurting. Pt contacted her PCP. They only instructed her to take Tylenol and not to ice it. She contacted the Public Health Dept they told her to take Ibuprofen and to ice it. She is getting conflicting information and doesn't know how to treat it.
72 2021-03-08 sleep disorder 3/4, 10PM -- MUSCLE PAIN AROUND NECK AND SHOULDERS -- WENT TO BED AT MIDNIGHT 3/5, 5AM -- WOKE UP WI... Read more
3/4, 10PM -- MUSCLE PAIN AROUND NECK AND SHOULDERS -- WENT TO BED AT MIDNIGHT 3/5, 5AM -- WOKE UP WITH CHILLS FOR ABOUT 2HRS. -- WENT BACK TO SLEEP 3/5, 9AM -- BOTH CHILLS AND MUSCLE PAIN WERE GONE -- INJECTION SITE WAS TENDER 3/7, 7PM -- LYMPH NODES UNDER MY LEFT ARM WERE SWOLLEN AND TENDER, BUT NOT PAINFUL 3/8, 4PM -- ITCHY, SWOLLEN SKIN ON LEFT ARM, BETWEEN INJECTION SITE AND ELBOW TODAY: 3/9, 2PM -- INJECTION SITE STILL TENDER, LYMPH NODES AND LEFT ARM STILL SWOLLEN AND TENDER
72 2021-03-09 feeling abnormal Slight Dizziness, severe Brain fog, eye socket and nasal inflammation. Symptom worsening over the f... Read more
Slight Dizziness, severe Brain fog, eye socket and nasal inflammation. Symptom worsening over the first two weeks, slowly resolving over past two weeks.
72 2021-03-09 incoherent, confusional state No problem with the first shot. Came back 28 days later for the second. Fine the day of the shot, bu... Read more
No problem with the first shot. Came back 28 days later for the second. Fine the day of the shot, but then had a 102 fever when I got up the next day, I didn't know what day of the week it was and had a good deal of trouble finishing sentences. This period of incoherence lasted for about 12 hours.
72 2021-03-13 insomnia, sleep disorder Could not sleep. Felt like on Ten cups of coffee. Could not think well Did not sleep for 24 hours Ex... Read more
Could not sleep. Felt like on Ten cups of coffee. Could not think well Did not sleep for 24 hours Extreme fatigue By 3rd day felt well
72 2021-03-13 loss of personal independence in daily activities 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 sleep disorder Right eye began to burn almost immediately, followed by clear runny nasal discharge, plus left eye b... Read more
Right eye began to burn almost immediately, followed by clear runny nasal discharge, plus left eye burning. 8 hours later, my hands, feet and nose became ice cold, head ached, arm began to hurt. Restless night, low grade fever. Progressed within 48 hours to epigastritis, intractable nausea?started Omeprazole on 3/11. Exhaustion lasted until Day 10 when I began to feel better and the nausea finally lifted. I do not want to go through this a second time but an asking you for guidance. I desperately want released from house confinement and separation from my children and grandchildren. Please help me with a decision of whether of not to take the second dose.
72 2021-03-14 excessive sleepiness chills, fever, lots of mucus, tired, slept all day.
72 2021-03-14 panic attack Moderna COVID?19 Vaccine EUA TWELVE DAYS AFTER THE VACCINE, on March 13, I awoke with severe dizzin... Read more
Moderna COVID?19 Vaccine EUA TWELVE DAYS AFTER THE VACCINE, on March 13, I awoke with severe dizziness and weakness, and moderate nausea. I could not stand or walk. I am reporting this because it is outside your normal prediction on the timinh of side effects. You need to add this vaeiation to your public information. I panicked and called the Nurse Hot Line -they told me to call 911 and go to the ER.. So I called another Nurst HotLine and they ld me to call 911 and go to the ER. Instead I simply slept for 35 hours and I am fine. Please mention in your information that in some cases, a reaction can occur up to 12 days later, Btw there is nothing in my medical history to otherwise explain the incident.
72 2021-03-15 confusional state At 3 a.m. I woke up with abdominal pain, then diarhea, vomiting, then severe chills and extreme shiv... Read more
At 3 a.m. I woke up with abdominal pain, then diarhea, vomiting, then severe chills and extreme shivering tremors, more diarhea and vomiting. This went on for 7 hours. About 12 hours later I began having a severe head ache which lasted for about 12 hours. Four days later I still have exhaustion and some confusion. BP seems ok.
72 2021-03-15 insomnia by 3pm my arm was sore and was sore for 3 days. by 6pm I had a severe headache that didn't allow me ... Read more
by 3pm my arm was sore and was sore for 3 days. by 6pm I had a severe headache that didn't allow me to sleep. took baby aspirin around 11pm. took celebrex at 2am and woke at 6am. Then boarded an airplane. no appitite. I went into chills and shaking and fever for an hour and a half. I slept off and on. I was on oxygen during the flight. My blood pressure was read by medics and it was fine. fever was 101. Headache was still persistent from the top of my head to the base of my skull. now on 3/16 the headache is from the top of my head to behind my left ear. on 3/14 Also had diarhea at 4pm and that evening arounf 6pm. Finally fell asleep with an ice pack on my head.
72 2021-03-16 sleep disorder On March 13, about 18 hours after my second shot, I arose to find myself with a fever of 100.5 degre... Read more
On March 13, about 18 hours after my second shot, I arose to find myself with a fever of 100.5 degrees, headache, serious fatigue and severe body aches from my neck to my knees in every area in which I have had past surgeries and repairs (neck, back, wrists, hip and left breast [lymph nodes removed due to cancer]). Most of that first full day I spent in bed sleeping, arising only around 6 p.m. for a bit of soup for dinner. By 9 p.m., I was back in bed and slept through to 9 a.m. on March 14. When I arose on March 14, the fever, headache and fatigue were gone, but the severe body aches remained in my hip and leg areas and became worse as the day went on. I alternately tried ice and heat to relieve the pain, but nothing helped. I could not sleep either. Finally, at around midnight, I took to extra-strength Tylenol, which finally kicked in an hour later and I slept until 8 a.m. on Monday, March 15. I had no symptoms when I awoke and continue with only a bit of fatigue.
72 2021-03-17 feeling abnormal Received vaccine 3/15/21 around 12 noon. Next day,3/16/21, had slight headache, generally felt bad, ... Read more
Received vaccine 3/15/21 around 12 noon. Next day,3/16/21, had slight headache, generally felt bad, had fever of 101.5 at 10 pm. Took Tylenol during the day and before going to bed. Next morning, 3/17/21, woke up with a rash from the middle of my neck down, front and back , both arms, and upper legs. Saw doctor. Received two antihistamines and a topical oil (Fluocinolone Acetonide)
72 2021-03-18 feeling abnormal Moderna COVID-19 Vaccine Chills and shaking at 6 PM day of shot. Then 36 hours later at... Read more
Moderna COVID-19 Vaccine Chills and shaking at 6 PM day of shot. Then 36 hours later at 11PM next day (3-9-2021) had SEVERE Shaking and Chills. This lasted 45 minutes. I could hardly walk and was not able to take full breaths. The next day felt awful but realized that I had had a deep muscle massage, the HARD Way. I drank a lot of water, much more than usual to get rid of toxins. The following day I felt fine.
72 2021-03-18 sleep disorder One day after injection a red rash developed just below the injection site and spread down to my elb... Read more
One day after injection a red rash developed just below the injection site and spread down to my elbow. The itching, burning, and aching associated with this rash interfered with my sleeping for two nights. The injection site itself turned black. Both of these problems began to clear up after 4 days. The rash is faint pink now, and the injection site bruise is now yellow in color. The only other symptom I had was a severe headache for 2 days which was resistent to Tylenol. The headache has cleared up.
72 2021-03-20 feeling abnormal 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 insomnia loopy; difficult sleeping; achy feeling in both legs and buttocks; ruptured blood vessel in left eye... Read more
loopy; difficult sleeping; achy feeling in both legs and buttocks; ruptured blood vessel in left eye; arm inflamed; arm hot; Arm red; arm itchy; mild headache; queasy GI symptoms; achy pain at injection site; A spontaneous report was received from a consumer concerning a 72-years-old elder female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events achy pain at injection site, mild headache, queasy gi symptoms, arm itchy, arm inflamed, arm red, arm hot, achy feeling in both legs and buttocks, loopy, difficult sleeping, ruptured blood vessel in left eye. The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 18 Feb 2021, the patient experienced the event(s) achy pain at injection site,On 19 Feb 2021, the patient experienced the event(s) mild headache, queasy gi symptoms. On 28 Feb 2021, the patient experienced the event(s) arm itchy, arm inflamed, arm red, arm hot. On an unknown date, the patient experienced the event(s) achy feeling in both legs and buttocks, loopy, difficult sleeping. On 3 Mar 2021, the patient experienced the events ruptured blood vessel in left eye which was considered as seriousness criteria. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of event(s), achy pain at injection site, mild headache, queasy gi symptoms, arm itchy, arm inflamed, arm red, arm hot, achy feeling in both legs and buttocks, loopy, difficult sleeping, ruptured blood vessel in left eye 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.
72 2021-03-22 confusional state Mental status changes - confusion lasting 2-3 days after first COVID vaccine and 24-48 hrs post seco... Read more
Mental status changes - confusion lasting 2-3 days after first COVID vaccine and 24-48 hrs post second vaccine on 3-19-21
72 2021-03-22 confusional state 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 crying, anxiety 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 excessive sleepiness, feeling abnormal For 4 days I had symptoms similar to the symptoms I had 15 years ago with ehrlichiosis. I could not... Read more
For 4 days I had symptoms similar to the symptoms I had 15 years ago with ehrlichiosis. I could not keep my eyes open, slept around the clock, weak, brain fog and loss of appetite. I have what?s called chronic lyme and I am able to manage it with a healthy lifestyle. It seemed to rush back. I am 5 days away from my vaccination and slowly regaining energy.
72 2021-03-22 sleep disorder Four hours after receiving the first dose I experienced substantial swelling , redness, heat, and a... Read more
Four hours after receiving the first dose I experienced substantial swelling , redness, heat, and a very heavy upper left arm. I was unable to sleep on that side for a week. The redness , swelling and heat lasted 14 days. My doctor looked at my arm on day 11 , and was surprised seeing the bright redness and feeling the heat 11 days after vaccination. The full healing finally occurred on day 15. Hence I opted not to get the second dose since the reaction might be far greater.
72 2021-03-23 confusional state, impaired work ability, sleep disorder I had the slight headache and sore arm when I first woke up, but it didn?t keep me from working in m... Read more
I had the slight headache and sore arm when I first woke up, but it didn?t keep me from working in my studio. By noon I realized my head was hurting more and I was making mistakes, so I quit for the day. No soon had I cleaned up and left my head started really banging and I felt like I had a really bad sunburn all over. I didn?t want anyone or anything to touch me. Even the clothes I was wearing irritated my skin. I had to lay down and felt nauseous,, and I had a steadily increasing fever. For someone who rarely breaks 97 F on my oral thermometer, reaching 101 was not expected. I was confused and not making sense. For example I told my husband he was the cat calling the canary black. He laughed at my mixed metaphor, saying you mean the pot that calls the kettle black. I dozed, but didn?t really sleep. Around midnight I realized the headache was easing up and my temperature dropped to 99.5F. When I woke in the morning the temperature and headache ere gone and all that remained was about a 6 inch diameter red ring around the injection site, but the episode was basically over. Thanks for listening.
72 2021-03-23 delirium 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 2021-03-23 fear 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 2021-03-24 feeling abnormal 3 days after the vaccine: Spastic Diarrhea (2 episodes). Shortness of breath. Loss of balance. Lo... Read more
3 days after the vaccine: Spastic Diarrhea (2 episodes). Shortness of breath. Loss of balance. Loss of appetite. Very low energy. Foggy brain, constant ringing in the ears: constant "pressure cooker". Yesterday, visited my generalist's who said they have had several cases with similar symptoms.
72 2021-03-25 insomnia 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 insomnia insomnia; chest pain; woozy feeling in head; knee and back pain; high blood sugar
72 2021-03-28 feeling abnormal Shooting pain in cheeks, ear (perhaps due to nerve endings)?; painful headache; brain fog; extreme f... Read more
Shooting pain in cheeks, ear (perhaps due to nerve endings)?; painful headache; brain fog; extreme fatigue; fever (not over 100 degrees F; muscles in legs feel like I hiked 20 miles (still hard to walk since Saturday, 3-27-21 and until today, 3-29-21 and I usually walk a mile/day); injection site red and swollen to to size of 2 silver dollars, as per husband. The first injection was on 2-26-21 and not a major problem (tired and slight fever for a couple days). I don't know if I had this reaction from injection #2 due to having Multiple Sclerosis?
72 2021-03-30 hallucination Hallucinated a little bit; Soreness in arms; Sick; no appetite; no sense of smell; No energy; Shortn... Read more
Hallucinated a little bit; Soreness in arms; Sick; no appetite; no sense of smell; No energy; Shortness of breath; Itchy on back; Very winded, like coming up a flight of stairs; Chills; High fever; A spontaneous report was received from a customer concerning a 72-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sick/illness, high fever/pyrexia, chills, couldn't move, soreness in arms/pain in extremity, felt like she had Covid, no appetite/decreased appetite, no sense of smell/anosmia, no energy/asthenia, hallucinated a little bit/hallucination, shortness of breath/dyspnea, itchy on back/pruritus and very winded like coming up a flight of stairs. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 03 Mar 2021, approximately 2 days prior to the event, the patient received their dose of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. After receiving the vaccine the patient experienced sickness, high fever, chills, couldn't move, soreness in arms, felt like Covid, no appetite, no sense of smell, no energy, hallucination, shortness of breath, itching, and very winded like coming up a flight of stairs. No other details were reported. Treatment information was not reported. Action taken with the drug in response to the event is not applicable The outcome of the events sick/illness, high fever/pyrexia, chills, couldn't move, soreness in arms/pain in extremity, felt like she had Covid, no appetite/decreased appetite, no sense of smell/anosmia, no energy/asthenia, hallucinated a little bit/hallucination, shortness of breath/dyspnea, itchy on back/pruritus and very winded like coming up a flight of stairs were considered to be 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 the events, a causal relationship cannot be excluded.
72 2021-03-30 hallucination hallucinations, vomiting, nausea, and didn't feel well for days after
72 2021-03-30 sleep disorder Received call from client stating that the evening of her second immunization she began to feel seve... Read more
Received call from client stating that the evening of her second immunization she began to feel severe 'razor blade like' pain in her L arm (muscles), joints and several fingers as well as a sensation of severe heat in L hand (reports R hand is cool to normal in temp. No edema or errythema reported. Complains of random and fleeting moments of feeling flushed and feverish s/s with temp reaching 99.5 degrees F. L arm remained extremely painful for > two weeks which keeps her up at night. Ice is the only relief for pain. Saw private MD reportedly dx with myalgia and arthralgia. As of 3/30/21 she cannot lift her L arm above the height of her chest. Reports MD is ordering labwork to help dx possible infection, viral response, etc... non specific report given of medical plan for intervention.
72 2021-03-31 disorientation Feel feverish but normal temperature. Feel disoriented.
72 2021-03-31 feeling abnormal, confusional state PATIENT WAS EXTREMELY TIRED AND "OUT OF IT" AND SAID SHE HAD SUCH CONFUSION AND COULDNT EVEN HEAR WH... Read more
PATIENT WAS EXTREMELY TIRED AND "OUT OF IT" AND SAID SHE HAD SUCH CONFUSION AND COULDNT EVEN HEAR WHAT HER HUSBAND WAS SAYING. HUSBAND TOOK HER TO THE HOSPITAL AND THEY RAN A BUNCH OF TESTS AND EVERYTHING CAME BACK OK. THIS HAPPENED WITH HER FIRST DOSE AS WELL, MODERNA 03/03/21 LOT 013A21A, BUT ALSO HAPPENED A YEAR AGO AROUND THE SAME TIME OF YEAR.
72 2021-03-31 feeling abnormal, incoherent 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 feeling abnormal Vaccine Induced Hepatitis; liver enzymes were elevated; terrible flank pain; very cranky since the s... Read more
Vaccine Induced Hepatitis; liver enzymes were elevated; terrible flank pain; very cranky since the shot; nauseous; fatigue; vomiting; severe epigastric pain; urine had blood in it; sicker than a dog; A spontaneous report was received from nurse, concerning herself, a 72-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue, sickness, epigastric pain, covid arm, rusty urine, vomiting, nauseous and vaccine induced hepatitis. The patient medical history was reported as unknown. concomitant drugs were not provided. On 4 Mar 2021, the patient received their first two of two planned doses of mRNA-1273 (Lot number: 027A21A) intramuscularly in the arm of prophylaxis of COVID-19 infection. On 4 Mar 2021, Patient experienced fatigue, sickness, epigastric pain, rusty urine, blood I urine, vomiting, nauseous. On 19 Mar 2021 for her annual exam and her liver enzymes were elevated, doctor states that it was vaccine induced hepatitis. Action taken with mRNA-1273 in response to the events was not reported. The outcome of all events were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
72 2021-03-31 feeling abnormal Felt like I had Covid again.. general feeling awful. 101 temp, temp lasted 3 days, nausea, no appeti... Read more
Felt like I had Covid again.. general feeling awful. 101 temp, temp lasted 3 days, nausea, no appetite, and next three days sweat for morning, noon and night. Diarrhea started and certain foods tasted funny.
72 2021-03-31 sleep disorder It took 5 days to recover. It was like riding a horse through CoVid-19 with each symptom lasting fro... Read more
It took 5 days to recover. It was like riding a horse through CoVid-19 with each symptom lasting from 12 to 24 ish hours: headache, chills, buzzing snapses type things in my head, freezing and needed heating pad to stop shaking, weakness so bad I could not get off my couch on my own. I had a fever, 2 degrees above normal. Then I got severe stomach / intestinal cramps and pain, I had to lay down and hold my stomach for a few hours. I became inconvenient and it felt like I had a UTI. Then it rolled into a sore throat, swollen glands on side of my neck with ear pain, and neck pain. Then it rolled into my chest with bad pain from throat to middle of chest and it was hard to breathe. By Monday I started to feel better but for the severe pain in the middle of my chest with coughing every time I took a small breath, had to breathe through my mouth. Tuesday at about 2:30 am I started to breathe again. I could not sleep for the first 72 hours and had to go to the bathroom every hour to one and a half hours.
72 2021-04-01 depressed mood I believe I had a sudden drop in Serotonin levels. I became very depressed very quickly. I even ha... Read more
I believe I had a sudden drop in Serotonin levels. I became very depressed very quickly. I even had thoughts of suicide surface. I did not reach out for help because I knew I could manage it. I have worked in mental health and chemical dependency. It lasted about 6 hours and then I was fine. In retrospect, I believe I had a similar reaction with the first injection on February 8th, 2021 at 10 am with the reaction starting about 7 pm that evening and lasting 24 hours. I did not connect it to the vaccine at that point. I have been talking to a therapist since the beginning of the pandemic due to isolation I have been experiencing mild depression that comes and goes but is very manageable. This was much more intense and more sudden and immediate. I did not feel at risk even with suicidal ideation, but felt I should report it because if other less experience, educated people experience this it could be dangerous. It took me so long to report because, in my 70's, I couldn't figure out how until one of my children visited and showed me.
72 2021-04-01 hallucination, feeling abnormal Fever, chills, joint aches. Took Tylenol to relieve fever and joint aches. Sleep caused hallucinatio... Read more
Fever, chills, joint aches. Took Tylenol to relieve fever and joint aches. Sleep caused hallucinations. Lasted all night after 2nd injection. Fuzzy brain the day after 2nd injection, fever, chills next night as well, continued to take Tylenol.
72 2021-04-01 loss of personal independence in daily activities, insomnia, anxiety RN administered injection incorrectly into the bursa, not IM. This resulted in extreme pain and inab... Read more
RN administered injection incorrectly into the bursa, not IM. This resulted in extreme pain and inability to move arm. Began having muscle spasms in lower back using different muscle to reposition and for ADLs. Finally was able to see doctor 3-12-21. Given scripts for Tramadol and muscle relaxant. Had follow up appointment with Sports Medicine MD to receive a steroid injection in Left shoulder. Diagnosed with SIRVA (Shoulder Injury Related to Vaccine Administration) I now require Physical Therapy. I am unable to use my arm per MD and PT. I have difficulty dressing, cooking, routine housekeeping, etc. While I feel better since the injection, I am terrified the pain will return. I live alone and was unable to sleep, drive, dress, cook or do any ADLS including wash my hair or dress. The pain was completely debilitating. Even after the steroid injection, I have physical therapy and MD appointments, daily exercises and instructions to not use my arm.
72 2021-04-02 excessive sleepiness I fell asleep for a full 24 hours after vaccine. I was too tired to stay up past 8:30 pm and woke u... Read more
I fell asleep for a full 24 hours after vaccine. I was too tired to stay up past 8:30 pm and woke up the next evening at 8:00pm. I lost a whole day! I continued to be unable to stay awake longer than 12 hours a day; always sleepy. Several days after vaccination itchy, red, swollen eyelids began and continue. They do not look infected as in conjunctivitis, just red. swollen and itchy with no discharge. I do not know if the itchy eyes are from the COVID vaccine, but assumed the extreme sleepiness was from the injection.
72 2021-04-04 sleep disorder, feeling drunk Left side started several hours after injection: pain from below cranium, across shoulder, down the ... Read more
Left side started several hours after injection: pain from below cranium, across shoulder, down the arm to the elbow. Very tender, painful lateral point between shoulder and elbow lasting for about 10 days; could not lay on left side. Injection site not especially tender. Extreme fatigue, resting not restful lasting for about 10 days--st. A lot of trouble sleeping; went on for about 7 nights. Four nights of low-grade fever, low-grade chills, and low-grade headache. Felt tipsy when up lasting for 2 weeks; still an issue but much better. Winded when walking or talking; still an issue but getting much better. I can still get a 'spin' if talking and walking at the same time; passes quickly if I lean on something.
72 2021-04-04 sleep disorder I have had tinnitus for Many Years . It has always been at a low level and did not bother me. appro... Read more
I have had tinnitus for Many Years . It has always been at a low level and did not bother me. approximately 3-4 days after I took the Moderna Vaccine by tinnitus became intolerable . there were nights that I had difficulty sleeping . Some days it would spike more than others . I took the second dose and it did not a make the spikes more or less. The only other times I had such annoying spikes were when I took Doxycycline and Zithromax . Spikes after doxycycline - which was severe - disappeared as soon as I stopped taking it The Zithromax spike took 2 months to settle down
72 2021-04-05 excessive sleepiness 4/4/2021 7:00 pm vaccine site and arm pain 8:30 pm Chills. Temp 100. 4/5/2021 3:00 am Increased pa... Read more
4/4/2021 7:00 pm vaccine site and arm pain 8:30 pm Chills. Temp 100. 4/5/2021 3:00 am Increased pain vaccine arm, chills, temperature 101.1, severe headache, muscle pain, joint pain, neck and back stiffness, fatigue, nausea, mild diarrhea. No ekes is. 8:00 am. Temperature 101.3. Headache. Entire body aches as though I have Influenza. Neck and shoulders stiffness. Severely fatigued. No appetite. Slept all day. Didn?t eat. 4/6/2021 Tired but pains lessened. Other symptoms mild.
72 2021-04-06 feeling abnormal, loss of personal independence in daily activities Dose #1 - mild pain at injection side and mild fatigue Dose #2 - I awoke at 3 a.m. with severe muscl... Read more
Dose #1 - mild pain at injection side and mild fatigue Dose #2 - I awoke at 3 a.m. with severe muscle and joint pain in my entire body (11 hours following injection). I have had fibromyalgia for years but have never experienced this level of pain. Pain and stiffness is extremely severe at night or after sitting resulting in inability to walk upon rising due to pain in my legs and hips. The pain subsides to a tolerable level upon stretching and moving throughout the day but is still significant. Climbing stairs is painful and unstable and pain in upper body arms, neck, back inhibits my usual exercise and daily routines.
72 2021-04-07 feeling abnormal Severe pain throughout entire body. Couldn't walk without support. Choked when trying to drink wat... Read more
Severe pain throughout entire body. Couldn't walk without support. Choked when trying to drink water. Couldn't speak above a whisper and only a few words at a time. Dizzy and foggy brain function. Husband took me to the local fire station where they transported me to the ER. The doctor there put me on IV Fluids, (lactated ringers), & (ondansetron (Zofran ).
72 2021-04-08 nervousness 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 2021-04-12 amnesia Two hours after I had memory loss and couldn?t remember what I did that day, my husband called the n... Read more
Two hours after I had memory loss and couldn?t remember what I did that day, my husband called the nurse hotline and they had me raise my arms and speak and smile but because of the memory loss they said to call the paramedics and my blood pressure was 230/105 and they thought I was having a stroke. My husband took me to the hospital ER and that evening I was checked in because my BP was 225/105 they thought I was have a stroke. At the hospital, I had the first CT head w/o contrast, then a head neck CT scan and I was admitted into the hospital. The follow day they did an electrocardiogram, then an echocardiogram, renal and duplex test, chest x-Ray MRI brain w/o contrast. There was no pain headache or body aches, then I was starting to remember what I had done the day before. A neurologist came into explain the results and all tests were negative, but I was diagnosed with Fibral Muscular Dysplasia, but because they didn?t have enough data, he couldn?t say that it was because of the Moderna vaccine. I was released 24 hours later. My BP went back to normal 120/70 3 days later.
72 2021-04-12 hallucination Hallucinations; Skin turned "yellow"; body smelled like "old Urine"; her urine was the color of "cof... Read more
Hallucinations; Skin turned "yellow"; body smelled like "old Urine"; her urine was the color of "coffee"; Fever; Chills; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of HALLUCINATION (Hallucinations) 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. The patient's past medical history included COVID-19 on 03-Dec-2020. Concurrent medical conditions included Scleroderma. 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 HALLUCINATION (Hallucinations) (seriousness criterion medically significant), YELLOW SKIN (Skin turned "yellow"), SKIN ODOUR ABNORMAL (body smelled like "old Urine"), CHROMATURIA (her urine was the color of "coffee"), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Mar-2021, HALLUCINATION (Hallucinations), YELLOW SKIN (Skin turned "yellow"), SKIN ODOUR ABNORMAL (body smelled like "old Urine"), CHROMATURIA (her urine was the color of "coffee") and PYREXIA (Fever) had resolved. At the time of the report, CHILLS (Chills) and FATIGUE (Fatigue) 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 reported. The 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.
72 2021-04-13 confusional state 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 2021-04-14 sleep disorder Sore arm, onset 13 hours after injection. Severe enough to wake me up. Took Arnica 200, improved gra... Read more
Sore arm, onset 13 hours after injection. Severe enough to wake me up. Took Arnica 200, improved gradually over 12 hours. Flu-like body aches. Onset 15 hours after injection. Mild intensity. Improved gradually over next 15 hours. Intense fatigue. Onset 15 hours. Slept approx 6 hours day following vaccine, plus slept 6 hours next night. Improved gradually over next 15 hours. Red, blotchy rash on chest and red rash back (waist to neck) 2 days after vaccine. Plainly visible. Improved but still present today (day 3)
72 2021-04-15 confusional state Patient presented to ED with generalized weakness and fatigue in setting of COVID-19 diagnosis one d... Read more
Patient presented to ED with generalized weakness and fatigue in setting of COVID-19 diagnosis one day prior. Patient was confused on presentation. Patient admitted and treated with convalescent plasma, remdesivir, steroids, and antibiotics. Patient improved and was discharged to home with new home oxygen.
72 2021-04-15 loss of personal independence in daily activities, nervousness Day after (3/31) I felt shaky and uncoordinated - enough that I did not want to go on a step ladder.... Read more
Day after (3/31) I felt shaky and uncoordinated - enough that I did not want to go on a step ladder. Next day (4/1) I was dusting lower shelves at home and when I stood up felt a snap in my lower back. Sharp pain which seemed to expand to my spine and lower torso -- basically forced me to bed for several days. Pain has persisted since then, and while it seems to be improving it has continued to inhibit daily activities, especially bending. This has been accompanied by bouts of tremors, shaking etc. (particularly in my arms and hands) as well as a sense of tremors even when there aren't any. There is also a persistent sense of not knowing exactly where I am in space. I drop things more frequently. While I have had some back problems in the past, these upper body manifestations are entirely new.
72 2021-04-17 insomnia Very sore arm (more than 1st dose) 2-3 days. Cold chills, began 14 hrs after receiving vaccine, last... Read more
Very sore arm (more than 1st dose) 2-3 days. Cold chills, began 14 hrs after receiving vaccine, lasted 5-6 hrs (woke in the night, couldn't get warm). Insomnia the night of the vaccine, from midnight till about 5 am (when I was so cold) Extreme fatigue after getting up about 7 am; slept most of the time from 7 am through 3 pm. Slight nausea, no appetite, 24 hrs.
72 2021-04-18 feeling abnormal 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 2021-04-19 feeling abnormal Same day, arm hurt bad, very tired, didn't feel like myself. Next day (2) very lethargic and tired. ... Read more
Same day, arm hurt bad, very tired, didn't feel like myself. Next day (2) very lethargic and tired. Next day (3) same but later in the evening around 7:00 pm I looked in the mirror and I had red hives all over neck, chest, arms & stomach. Called my Dr. she said take Tylenol for sore arm and take 50 mg of Benadryl for hives, and go to bed early. Next day (4) hives were pink instead of red. Later that evening hives almost were gone. Next day(5) I felt half way decent and hives were gone. Next day (6) felt almost normal.
72 2021-04-20 sleep disorder Swelling at injection site and upper arm leading to burning sensation and occasional sharp pain in u... Read more
Swelling at injection site and upper arm leading to burning sensation and occasional sharp pain in upper arm that radiates from injection site and lasts about 15 minutes. Pain still occuring after 5 weeks and getting more frequent. Hard to sleep. Pain responds to ice. Dr. prescribed Meloxicam & Cyclobenzaprine ( started 4/21/2021)
72 2021-04-21 anxiety AFTER RECEIVING THIS DOSE SHE FELT ANXIOUS. ON SITE EMS RESPONDED. VITALS LISTED BELOW SHE WAS MONIT... Read more
AFTER RECEIVING THIS DOSE SHE FELT ANXIOUS. ON SITE EMS RESPONDED. VITALS LISTED BELOW SHE WAS MONITORED AND FELT BETTER AND WAS RELEASED TO HOME.
72 2021-04-22 mental status changes Pt tested negative using antigen test on 4/16/21 upon admission to emergency room; Pt requested to r... Read more
Pt tested negative using antigen test on 4/16/21 upon admission to emergency room; Pt requested to receive moderna vaccine on 4/20/21 (family signed consent). Pt was screened for s/s of covid prior to administration of vaccine on 4/20/21. Vital signs were within normal limits and temp was 97.5. Pt started having covid related symptoms on 4/21/21 late afternoon ( fever 102 f, congestion and change in mental status). Pt was sent out via EMS to local hospital for evaluation. Covid test was performed with positive results noted.
72 2021-04-23 amnesia, memory impairment 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 feeling abnormal Fatigue; not chills, rather I was FROZEN from my solar plexus to my feet. I could not get warm with ... Read more
Fatigue; not chills, rather I was FROZEN from my solar plexus to my feet. I could not get warm with the heater turned up and under piles of blankets for at least 10-12 hours. Fever 100.2; severe muscle pain down outside of both thighs and lower back. By 5 pm I could barely stand or walk. Very unstable. On 4/23, I had a milder version of side effects, profound fatigue and slight fever.
72 2021-04-24 anxiety 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 2021-04-25 anxiety Anxious and dizziness
72 2021-04-26 disorientation had anaphylactic reaction after 12 days; itching; ringing in her head; wooziness; disorientation; tr... Read more
had anaphylactic reaction after 12 days; itching; ringing in her head; wooziness; disorientation; trouble swallowing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (had anaphylactic reaction after 12 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Food allergy (History of reactions to food). Concomitant products included DIPHENHYDRAMINE for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced ANAPHYLACTIC REACTION (had anaphylactic reaction after 12 days) (seriousness criterion hospitalization), PRURITUS (itching), TINNITUS (ringing in her head), DIZZINESS (wooziness), DISORIENTATION (disorientation) and DYSPHAGIA (trouble swallowing). The patient was hospitalized on 14-Feb-2021 due to ANAPHYLACTIC REACTION. At the time of the report, ANAPHYLACTIC REACTION (had anaphylactic reaction after 12 days), PRURITUS (itching), TINNITUS (ringing in her head), DIZZINESS (wooziness), DISORIENTATION (disorientation) and DYSPHAGIA (trouble swallowing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Several days after the first Moderna vaccination on 14Feb2021, the husband reported that after dinner the patient experienced itching, ringing in her head, wooziness, trouble swallowing, and disorientation. We called 911 and the ambulance came and took her to the hospital. time. At the emergency department, they did lot of tests, but negative result. On an unspecified date the patient was seen by an allergist and food allergies were ruled out by the allergist. No additional treatment information was provided. Action taken was reported as 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-2021-081674 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Anaphylactic reaction captured in event tab as medically significant and the emergency department did lot of tests, but negative result.; 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-2021-081674:Dose 1
72 2021-04-26 feeling abnormal, mental impairment, agitation, confusional state 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 2021-04-30 feeling abnormal 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 2021-05-03 feeling abnormal Left ear hearing loss; unilateral vision loss; Brain fog; Hot; Swelling in her arm that is the size ... Read more
Left ear hearing loss; unilateral vision loss; Brain fog; Hot; Swelling in her arm that is the size of a baseball; COVID Arm; Itchy; Red circle around injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Left ear hearing loss) and BLINDNESS UNILATERAL (unilateral vision loss) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dairy intolerance. Concomitant products included DOXYCYCLINE from 01-Jan-2020 to an unknown date for Rosacea, DEXLANSOPRAZOLE (DEXILANT) and FAMOTIDINE for Stomach discomfort, ROSUVASTATIN for Stroke, LEVOTHYROXINE for Thyroid disorder NOS, CLOPIDOGREL, CALCIUM, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and MAGNESIUM OXIDE for an unknown indication. On 29-Jan-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 9:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced FEELING ABNORMAL (Brain fog), VACCINATION SITE WARMTH (Hot), PERIPHERAL SWELLING (Swelling in her arm that is the size of a baseball), VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red circle around injection site) and FATIGUE (Tired). On an unknown date, the patient experienced DEAFNESS UNILATERAL (Left ear hearing loss) (seriousness criterion medically significant) and BLINDNESS UNILATERAL (unilateral vision loss) (seriousness criterion medically significant). On 13-Feb-2021, VACCINATION SITE REACTION (COVID Arm) had resolved. At the time of the report, DEAFNESS UNILATERAL (Left ear hearing loss), FEELING ABNORMAL (Brain fog), VACCINATION SITE WARMTH (Hot), PERIPHERAL SWELLING (Swelling in her arm that is the size of a baseball), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red circle around injection site) and FATIGUE (Tired) outcome was unknown. Treatment information 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. Based on the current 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: Case upgraded to serious based on event update. Con meds added. Prior event outcome updated. Medical history updated based on information; 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 2021-05-04 sleep disorder Tinnitus, mostly in left ear. Can be severe. Disrupting sleep and ability to fall asleep. Started A... Read more
Tinnitus, mostly in left ear. Can be severe. Disrupting sleep and ability to fall asleep. Started April 1. Is there 24 hours a day.
72 2021-05-05 sleep disorder Tinnitus sound was doubled. Screaming loud in the middle of the night. Daytime sound enormously lo... Read more
Tinnitus sound was doubled. Screaming loud in the middle of the night. Daytime sound enormously louder as well. Previous tinnitus very light. The increase has not diminished since Feb. 16. No effect on hearing. Very debilitating. Reaction after the first dose was minimal with no effect on tinnitus. (Received January 16 at .).
72 2021-05-13 anxiety 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 2021-05-16 hallucination Headache, high fever, hallucinations, chills, swollen face, itchy face
72 2021-05-16 sleep disorder She woke in the middle of the night 5/3/21 with "extreme" pain in left calf. Her leg was very sensit... Read more
She woke in the middle of the night 5/3/21 with "extreme" pain in left calf. Her leg was very sensitive - even the bed sheets were painful to her left calf. The next AM 5/3/21 - the pt applied bilateral compression hose, wore them continuously with no decrease in pain. Pt states "I'm very stubborn and I probably should have called or seen someone, but I didn't". She was planning on flying and her friends started advising her not to travel in case she had a blood clot. The pain never subsided and she presented to ER on 5/11/21. The ER did a full work up. They called in RX of Xarelto. Her pharmacy did not have it in stock on 5/11/21. Yesterday (5/12) Started Xarelto 15mg BID x 3 weeks; then on week 4 - will increase to 20mg once daily.
72 2021-05-19 anxiety, insomnia Insomnia for 12 days....anxious.....face bright red on 5 th day.....hot and cold feeling.....metalli... Read more
Insomnia for 12 days....anxious.....face bright red on 5 th day.....hot and cold feeling.....metallic taste in mouth on 7 th day........dry mouth. 10 th day was better but 2 more days of sleeplessness.
72 2021-05-19 excessive sleepiness, feeling 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 2021-05-21 panic reaction Vaginal bleeding (Medium blood flow, Not Spotting); panicking; This spontaneous case was reported by... Read more
Vaginal bleeding (Medium blood flow, Not Spotting); panicking; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 3:47 PM, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) (seriousness criterion medically significant) and PANIC REACTION (panicking). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding (Medium blood flow, Not Spotting)) and PANIC REACTION (panicking) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was not taking any blood thinners and had no Chronic Medical conditions. Concomitant medications and treatment information was not provided. The patient reported that it was not Hemorrhoids and was panicking because she heard someone died from bleeding after receiving the vaccine. This case concerns a 72-year-old female with a serious unexpected event of vaginal hemorrhage, and nonserious unexpected panic reaction. Latency 3 days after first mRNA-1273 dose. 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: This case concerns a 72-year-old female with a serious unexpected event of vaginal hemorrhage, and nonserious unexpected panic reaction. Latency 3 days after first mRNA-1273 dose. 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 2021-05-24 loss of personal independence in daily activities The day after the shot Ihad widespread muscle an joint pain, I had fatigue and muscle weakness. I co... Read more
The day after the shot Ihad widespread muscle an joint pain, I had fatigue and muscle weakness. I could not get out of bed or mve until 6 pm that night. Now I have daily muscle weakness, difficulty walking, muscle pain, fatigue. I wake up at night and have to take pain medication.
72 2021-06-02 sleep disorder It started with on-going muscle aches and stiffness in my arms from elbow through fingers and legs f... Read more
It started with on-going muscle aches and stiffness in my arms from elbow through fingers and legs from knee through feet. Experience has taught me that this means my thyroid meds were not as effective, This continued for almost 2 months. It finally seemed to be resolved but 5 days later I started with itching and hives on my body and particularly face and head within 30 minutes after taking my thyroid medicine which i take 4 times a day. It feels like there is a small bug or hair rubbing against my skin. This continues through today making it difficult to sleep for more than an hour at a time. It seems to me that this mRNA vaccine is blocking my thyroid medication from being taken up by the muscle cells. Taking an antihistamine lessens the itch but then messes with my head because of my age. I cannot live without my thyroid medication. Now what do I do???
72 2021-06-03 excessive sleepiness Heart skips beats Felling faint Extremely tired Wanting to sleep all the time No Energy
72 2021-06-03 sleep disorder, excessive sleepiness Day 1 Nausea & Vomiting extreme fatigue, Day 2 Slept all day and fitfully through night. 2. Slept a... Read more
Day 1 Nausea & Vomiting extreme fatigue, Day 2 Slept all day and fitfully through night. 2. Slept all day, no food consumed, water in huge amount. Day3. Diarrhea, slept again most of day and did eat lightly. Day 4. fell normal but tied and sleepy buy less so than previous.
72 2021-06-08 emotional distress, feeling abnormal Worse asthma; Bronchitis; allergic to ingredients; Burning stool; Feeling not herself / Has been mis... Read more
Worse asthma; Bronchitis; allergic to ingredients; Burning stool; Feeling not herself / Has been miserable; Feeling weak; believes that she has poison in her body; suffering for four months/ suffering the past couple of months; Whole stomach is covered with red bumps/has more bumps in the crack of her behind, under her behind, in between her legs,all over the inside of her arms; Hives all over her body/temperature hives. itchy and painful to touch/hurt like shingles; Painful to touch; Itchy bumps in the crack of the behind/ under the behind/ between legs/inside of the arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (Worse asthma), BRONCHITIS (Bronchitis) and AUTOIMMUNE DISORDER (Autoimmune disease got affected/ autoimmune system affected) 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. The patient's past medical history included Pregnancy (Had 2 natural child birth), Surgery (Spine, patient has implants in spine) and Surgery. Concurrent medical conditions included Sulfonamide allergy, Disability, Hives, Autoimmune disorder and Allergy to chemicals. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced URTICARIA (Hives all over her body/temperature hives. itchy and painful to touch/hurt like shingles), PAIN (Painful to touch), PRURITUS (Itchy bumps in the crack of the behind/ under the behind/ between legs/inside of the arms), EMOTIONAL DISTRESS (suffering for four months/ suffering the past couple of months) and RASH ERYTHEMATOUS (Whole stomach is covered with red bumps/has more bumps in the crack of her behind, under her behind, in between her legs,all over the inside of her arms). On an unknown date, the patient experienced ASTHMA (Worse asthma) (seriousness criterion hospitalization), BRONCHITIS (Bronchitis) (seriousness criterion hospitalization), AUTOIMMUNE DISORDER (Autoimmune disease got affected/ autoimmune system affected) (seriousness criterion medically significant), ALLERGY TO VACCINE (allergic to ingredients), FAECES HARD (Burning stool), FEELING ABNORMAL (Feeling not herself / Has been miserable), ASTHENIA (Feeling weak) and FEELING ABNORMAL (believes that she has poison in her body). The patient was treated with ALBUTEROL [SALBUTAMOL] for Bronchitis, at a dose of UNK dosage form, qid; CETIRIZINE for Hives, at a dose of 1 dosage form four times per day and LEVOCETIRIZINE for Hives, at a dose of 1 dosage form four times per day. At the time of the report, ASTHMA (Worse asthma) and AUTOIMMUNE DISORDER (Autoimmune disease got affected/ autoimmune system affected) had not resolved, BRONCHITIS (Bronchitis), ALLERGY TO VACCINE (allergic to ingredients), PAIN (Painful to touch), PRURITUS (Itchy bumps in the crack of the behind/ under the behind/ between legs/inside of the arms), FAECES HARD (Burning stool), FEELING ABNORMAL (Feeling not herself / Has been miserable), ASTHENIA (Feeling weak), EMOTIONAL DISTRESS (suffering for four months/ suffering the past couple of months), RASH ERYTHEMATOUS (Whole stomach is covered with red bumps/has more bumps in the crack of her behind, under her behind, in between her legs,all over the inside of her arms) and FEELING ABNORMAL (believes that she has poison in her body) outcome was unknown and URTICARIA (Hives all over her body/temperature hives. itchy and painful to touch/hurt like shingles) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Other treatment information includes Breathing machine and Breo Ellipta hand haler. The patient went to pulmonologist for treatment of lungs. The patient took antibiotics for bronchitis. The patient was an allergic hives patient and disabled. Her whole stomach is covered with red bumps and started getting the adverse event symptoms the night of getting the vaccine. She had more bumps in the crack of her behind, under her behind, in between her legs, all over the inside of her arms, and burning stool. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up information received added new events, Medical history and treatment medications. On 25-May-2021: Follow-up information received on 25-May-2021 and information regarding serious events and case upgraded to serious, additional medical history and newtreatment medications added. On 26-May-2021: Follow-up received on 26-May-2021 contains information regarding medical history (allergy) and additional event (allergy to ingredients).; 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 2021-06-08 feeling abnormal I had a digestive issues after dinner the night of the vaccine. I had nausea and gastric pain. It c... Read more
I had a digestive issues after dinner the night of the vaccine. I had nausea and gastric pain. It continued such as I could not eat much but a bland diet. My stomach felt that after I had ate anything my stomach felt full. About an a few hours after eating I felt nausea. The symptoms continued from March to the end of May. I lost several pounds due to not eating. I felt not myself, I also felt afraid to eat due to feeling sick afterwards. I now feel like myself again and I can eat regularly. I also had a rash that itched that went away after a week. I did go to the doctor the last week of March. The second time I went to the doctor was the 14th of April. The following week on the 22nd I went to my gastroenterologist, he prescribed a stronger medicine for my stomach. I took the medicine for a few weeks and I still felt bad. He advised to take the medicine another week which helped.
72 2021-06-09 anxiety 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 2021-06-09 impaired work ability Headaches, fever and fatigue and chills. arm swore within 29 minutes home my whole body hurt. wasn't... Read more
Headaches, fever and fatigue and chills. arm swore within 29 minutes home my whole body hurt. wasn't able to work at all.
72 2021-06-13 feeling abnormal I felt a cold coming on before I took the shot the previous day. The shot was given to me because I ... Read more
I felt a cold coming on before I took the shot the previous day. The shot was given to me because I did not have a fever. Upon returning home I could not stop coughing and thought about going to the ER but did not. I went to the Pharmacy and the Pharmacist recommended taking some DM Cough medicine. I finally contacted my Doctor via tele-services and we discussed the fever, cough and why I was feeling bad.
72 2021-06-14 mental status changes 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 sensation of foreign body I developed a lump under my chin which I brought to the attention of my PCP. She wanted me to have ... Read more
I developed a lump under my chin which I brought to the attention of my PCP. She wanted me to have a core CT scan and a core biopsy. After that was completed, my PCP was relieved because she said that it looked benign. I had to go see an ENT for a consult with Dr. After looking at the results of the CT scan and the biopsy he told me that it was lymph node. It's not a salivary gland. It will not go away because there is too much dead tissue there. What he is going to do, on 06/18/21, is have a surgery and remove the entire lymph node and send it off to pathology. It's not painful, but it feels very unattractive.
72 2021-06-16 disorientation 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 2021-06-16 loss of personal independence in daily activities I had a big relapse in my chronic fatigue and could barely get off of my couch. It lasted about 3-4 ... Read more
I had a big relapse in my chronic fatigue and could barely get off of my couch. It lasted about 3-4 works.
72 2021-06-20 sleep disorder My right arm was achy and I kept getting tingly off and on. The next day it went to the left arm and... Read more
My right arm was achy and I kept getting tingly off and on. The next day it went to the left arm and I thought I was having a heart attack. I went to my doctor after my knees started hurting and I called the nurse practitioner and she ordered an X-ray; then, a week later I went back to my doctor and he prescribed a CBB drops medication for me and then after that did not work, he prescribed some gabapentin. The medication helped a little bit but then when I went to bed last night, I couldn't get to sleep at all.
72 2021-06-24 feeling abnormal 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 feeling abnormal SED rate and C Reactive Protiine as well as other bloodwork started being abnormal about ten days af... Read more
SED rate and C Reactive Protiine as well as other bloodwork started being abnormal about ten days after shot two. It did not go down until I was hospitalized May 7 and diagnosed with atypical pneumonia. Felt bad whole time and ran temps.
72 2021-07-01 feeling abnormal, confusional state 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 2021-07-01 feeling abnormal 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 2021-07-03 feeling abnormal July 2nd, had a headache, fever, chills, aches, sore joints, and my stomach felt awful... I took 2 ... Read more
July 2nd, had a headache, fever, chills, aches, sore joints, and my stomach felt awful... I took 2 Ibuprofen every 4 hours. July 3rd, felt great, even worked in the yard. July 4th, felt awful again, did very little, but not as bad as July 2nd.... Ibuprofen helped
72 2021-07-10 feeling abnormal, memory impairment Profound weakness begining approx. 12 hrs post vaccination. Patient unable to get up off toilet. Imp... Read more
Profound weakness begining approx. 12 hrs post vaccination. Patient unable to get up off toilet. Improved approx. 6 hours later after sleeping. Since that time, weakness continued, gait unsteady and brain fog symptoms present. Some level of anosmia and taste aberration. Patient began PT twice weekly in late April and continues now with weekly only. Memory and brain fog symptoms intermittent Taste aberrations ongoing Lab tests on 06/02/2021 WNL, Covid test Negative
72 2021-07-15 sleep disorder My left neck gland swelled up about an hour after receiving my vaccine. It went away quickly. I woke... Read more
My left neck gland swelled up about an hour after receiving my vaccine. It went away quickly. I woke up at 2 am on 3/5/21 with a strange headache right over my neck. I took Tylenol for the headache but then I could not go back to sleep. The following day the headache was gone but I was very tired and lethargic (3/5/21 & 3/6/21). I also had a fever on the afternoon on 3/5/21, it was 99 degrees maybe 100 degrees. I took Tylenol for that. All symptoms were fine by 3/7/21.
72 2021-07-19 feeling abnormal 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 2021-07-20 panic reaction, feeling abnormal 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 2021-07-22 amnesia, feeling abnormal Felt out of sorts. Repeatedly asked ?what happened ?? Taken by ambulance to hospital shortly after 1... Read more
Felt out of sorts. Repeatedly asked ?what happened ?? Taken by ambulance to hospital shortly after 1pm. Memory returned about 4:30 pm while finishing CTA. All cognitive testing normal after 4:30pm
72 2021-07-22 feeling abnormal severe allergic reaction. arm swelled up immediatly following shot then after 30 minutes my face li... Read more
severe allergic reaction. arm swelled up immediatly following shot then after 30 minutes my face lips & tongue swelled up bad and I felt very weak, I had a fever and my arm was very hot hurting and swollen for many days. I still do ot feel back to my normal self. I had to take prednisone as well as benadryl for over a week. use ice packs on my arm which hurt me very much to use..
72 2021-07-26 insomnia weakness/still has weakness; tingling throughout the body, arms legs and torso; no balance; diagnose... Read more
weakness/still has weakness; tingling throughout the body, arms legs and torso; no balance; diagnosed with vertigo likely from the equilibrium being off in the middle ear where "crystals can form; she couldn't walk- like a toddler / had to hang on to walls and furniture to walk; really bad dizziness/dizziness was like "being in an earthquake/"horrible" (dizziness); nausea; feels tired/sometimes still "feels tired"; light dizziness,dizziness "was like aswitch went off"; couldn't go to sleep during the night; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (diagnosed with vertigo likely from the equilibrium being off in the middle ear where "crystals can form) and GAIT INABILITY (she couldn't walk- like a toddler / had to hang on to walls and furniture to walk) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016A21A and 016A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included High cholesterol, Drug allergy (Vicodin) and Drug allergy (Codeine). Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) 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 21-Apr-2021, the patient experienced DIZZINESS (light dizziness,dizziness "was like aswitch went off") and INSOMNIA (couldn't go to sleep during the night). On 22-Apr-2021, the patient experienced VERTIGO (diagnosed with vertigo likely from the equilibrium being off in the middle ear where "crystals can form) (seriousness criterion intervention required), GAIT INABILITY (she couldn't walk- like a toddler / had to hang on to walls and furniture to walk) (seriousness criterion intervention required), ASTHENIA (weakness/still has weakness), PARAESTHESIA (tingling throughout the body, arms legs and torso), BALANCE DISORDER (no balance), DIZZINESS (really bad dizziness/dizziness was like "being in an earthquake/"horrible" (dizziness)), NAUSEA (nausea) and FATIGUE (feels tired/sometimes still "feels tired"). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) (oral) ongoing since an unknown date for Vertigo and Nausea, at a dose of 1 dosage form. At the time of the report, VERTIGO (diagnosed with vertigo likely from the equilibrium being off in the middle ear where "crystals can form), GAIT INABILITY (she couldn't walk- like a toddler / had to hang on to walls and furniture to walk), DIZZINESS (light dizziness,dizziness "was like aswitch went off"), ASTHENIA (weakness/still has weakness), PARAESTHESIA (tingling throughout the body, arms legs and torso), BALANCE DISORDER (no balance), INSOMNIA (couldn't go to sleep during the night) and NAUSEA (nausea) outcome was unknown, DIZZINESS (really bad dizziness/dizziness was like "being in an earthquake/"horrible" (dizziness)) had resolved and FATIGUE (feels tired/sometimes still "feels tired") had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: unknown (Inconclusive) Results not provided but patient's blood work was taken while in the ER. In April 2021, Computerised tomogram: unknown (Inconclusive) Results not provided but patient diagnosed with vertigo. Treatment administered in the Emergency Room (ER) included unspecified IV anti-vertigo medication and nausea medications. The patient was discharged from the ER with over the counter motion sickness medication to treat vertigo and nausea, in addition to the oral Zofran. At the time of the report the patient endorsed that she felt almost normal but that she was still experiencing weakness and sometimes still feels tired. 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 23-Jul-2021: Contact information confirmed.; 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.
72 2021-07-27 panic attack, delirium 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 feeling abnormal, memory impairment 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.
73 2020-12-31 anxiety Approximately 30 min post vaccination administration patient demonstrated SOB and anxiousness. Asses... Read more
Approximately 30 min post vaccination administration patient demonstrated SOB and anxiousness. Assessed at time of event: Heart sounds normal, Lung sounds clear. Vitals within normal limits for patient. O2 91% on 3 liters NC Continuous flow. 2 consecutive nebulized albuterol treatments were administered. At approximately 1.5 hours post reaction, patients' SOB and anxiousness had subsided and the patient stated that they were feel "much better".
73 2020-12-31 sleep disorder 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 2021-01-10 impaired work ability Patient said the day after she received the vaccine, there was a big red bump on the her arm below t... Read more
Patient said the day after she received the vaccine, there was a big red bump on the her arm below the injection site and she felt like there were cockroaches crawling on her skin. She had to miss work for two days. She reported feeling more sick from the vaccine than the COVID infection she had a few months ago.
73 2021-01-17 emotional distress A rash started developing about within a day or two of the vaccination. By day 4 or 5, the rash was ... Read more
A rash started developing about within a day or two of the vaccination. By day 4 or 5, the rash was spreading and appearing in other areas including scalp. By day 6, I was in complete distress. Saw Dermatologist on Day 6 and was prescribed Prednisone and increased antihistamines up to the day of the second injection scheduled for Feb 5, 2021. By today, Day 10, the rash has mostly receded while I continue meds prescribed. I believe that I had Covid early on starting March 28 accompanied by sudden fatigue, nausea, fever, chills, body aches, no appetite, for the first few days, then developed hives all over face and head until my eyes were swollen shut. My doctors, both derm and primary, didn't want me to be tested or come in or go to the hospital, perhaps because so early on in the pandemic, little was known and they feared if it wasn't Covid, I would contract it in those circumstances. They again prescribed creams and antibiotics and prednisone. I don't remember how the rash side effects lasted but I continue to have scalp problems since. I did not have a cough, but did experience instances of shortness of breath 7 to 10 days after the onset. The fatigue, body aches and brain fog continued for months. I was feeling much better by the time I got the vaccine and then returned to the rash symptoms I had had before.
73 2021-01-21 loss of personal independence in daily activities, feeling abnormal I became very weak following my vaccine. My arm where the injection was inserted had a strange feeli... Read more
I became very weak following my vaccine. My arm where the injection was inserted had a strange feeling. It took me about 1 hour before I felt able to drive myself home. Nurses gave me 2 bottles of water and took my blood pressure. It was 150/84 higher than normal for me.
73 2021-01-21 sleep disorder Minor soreness the day of the vaccine but have had continued are pain at the injection site and surr... Read more
Minor soreness the day of the vaccine but have had continued are pain at the injection site and surrounding muscles for almost three weeks. Saw my primary and she said it could be they gave it too high and irritated the shoulder joint. She is concerned about "frozen shoulder". It wakes me in the night and no position lasts without pain after 30-45 seconds. Take one extra strength Tylenol before bed and administer Sagely 250 mg. BD cream on upper arm and part of neck where pain exits. Last night I drank 3 glasses of red wine so I could sleep a few hours and today I have had no pain! little weakness and I'm trying not to aggravate it, but hopefully the site pain is resolving.
73 2021-01-25 sleep disorder Delayed onset reaction at injection site. Started with erythema, swelling, extremely hot skin. Area ... Read more
Delayed onset reaction at injection site. Started with erythema, swelling, extremely hot skin. Area increased in size for several days and covered most of upper arm. Was painful...woke me up during sleep when I rolled over on it. I applied cold compresses. I have a in nursing. I know a reaction when I see one!
73 2021-01-26 poor quality sleep left arm large wheal development two weeks after injection. About the size of a hand. itching swell... Read more
left arm large wheal development two weeks after injection. About the size of a hand. itching swelling and warm. treated with Caladryl
73 2021-01-27 feeling abnormal tingling of lips, tingling of tongue, numbness of left side of face, flushed face on left side. Occu... Read more
tingling of lips, tingling of tongue, numbness of left side of face, flushed face on left side. Occurred about an hour and a half post injection. Lasted about 30 minutes. 12 hours post injection - shortness of breath similar to asthma, tongue feeling slightly swollen, slight metallic taste. Lasted a couple of hours while watching tv - subsided. Day 4 - noticeable fatigue, headache, slight cough, sinus like congestion, muscle and joint aches, slight dizziness, foggy feeling, sluggish, but no fever. slowly resolved over next day.
73 2021-01-29 anxiety Patient arrived to observation room around 11am following vaccination with Moderna dose #1, no distr... Read more
Patient arrived to observation room around 11am following vaccination with Moderna dose #1, no distress noted, sitting in back of room. Around 11:05am, patient was seen by observation RNs as putting head down into hands and started to wave for assistance. Per patient, she felt hot, light-headed and faint. Patient's lower extremities were elevated on adjacent chair and 10LPM 02 administered via bag mask. Vital signs measured: p64, R22, BP120/76, 02:99%. Patient stated she felt mild "scratchiness" in her throat, which dissipated in less than 5 minutes. No presence or reports of angioedema, wheezing, shortness of breath, hypotension, rash/redness. Benadryl was drawn up and prepared in case of need for administration, Epipen also nearby. After about 20 minutes of sitting with legs elevated and O2 flowing, client reports feeling better, no longer feeling "scratchy" throat. Patient states she was anxious to receive vaccine and thinks symptoms are due to anxiety. Patient's husband present and assisted patient to car around 11:30am. No further intervention needed.
73 2021-01-30 feeling abnormal Awoke with eye infection both eyes eyes felt like sand paper! Blurred vision, watery and miserable
73 2021-01-31 disorientation, feeling abnormal, confusional state January 28, 2021 : Neck stiffened on left side, within 15 minutes of getting shot, could not turn he... Read more
January 28, 2021 : Neck stiffened on left side, within 15 minutes of getting shot, could not turn head. Subsided after three hours. Fever: 99.2; very tired. Slept for 12 hours. Friday, January 29: Experienced series of migraines with loss of vision. Chronic fatigue. (not prone to migraines). Dizziness. Saturday, January 30: Right side of face numb, right eye vision affected. Mentally disoriented and confused (brain fog). No medications taken at any time. Sunday, January 31/Monday, February 1: Dizziness
73 2021-01-31 mental status changes 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 2021-02-02 feeling abnormal Bad Chills, fever, headache, tiredness/fatigue, joint pain, nausea, stomach pain, injection site pa... Read more
Bad Chills, fever, headache, tiredness/fatigue, joint pain, nausea, stomach pain, injection site pain and swelling. I still don?t feel back to normal. The worst symptoms lasted about 24 hours.
73 2021-02-02 excessive sleepiness This event occurred 9 days post 2nd Moderna vaccine. I also had a delayed reaction after the first d... Read more
This event occurred 9 days post 2nd Moderna vaccine. I also had a delayed reaction after the first dose documented on v-safe. On 2/2/21: symptoms included fatigue, chills, and fever and night sweats and increase in sleep time. These symptoms also occurred on the day following the 2nd dose. As on the day following the 2nd dose, I self medicated on the evening of 2/2 with one ibuprofen/acetaminophen (125mg/250mg) tablet . No significant symptoms on waking on 2 / 3 / 21 other than mild fatigue.
73 2021-02-03 impaired work ability Extreme tiredness. Had to leave work. Could not function. Sweats and joint pain
73 2021-02-04 feeling abnormal Extreme chills 3 hours. Used weighted blankets; achieved slow warm up and chills stopped Elevated t... Read more
Extreme chills 3 hours. Used weighted blankets; achieved slow warm up and chills stopped Elevated temperature 101.8 - 100.8 -- Days 2- 4 in evenings after normal temp all days.- Took acetaminophen. Brain fog , physical clumsiness of movements.
73 2021-02-04 excessive sleepiness Within 5 minutes pain @ site with swelling, redness and pain. Then 1 hour some hives @ site. The ... Read more
Within 5 minutes pain @ site with swelling, redness and pain. Then 1 hour some hives @ site. The next day extremely tired and slept the entire day.But
73 2021-02-05 feeling abnormal 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 2021-02-05 feeling abnormal Tired at first, woke up hot and sweaty at 2:00 am, body ache, injection site very tender. Nausea of... Read more
Tired at first, woke up hot and sweaty at 2:00 am, body ache, injection site very tender. Nausea off and on all day and very tired, not with it
73 2021-02-06 excessive sleepiness During first 12 hrs after injection, I noticed only redness, mild discomfort and itching at injectio... Read more
During first 12 hrs after injection, I noticed only redness, mild discomfort and itching at injection site. By 12 hrs later, I began to experience fever, chills, nausea, headache, muscle and joint discomfort, dizziness, diarrhea, fatigue. This lasted all night. The day following injection I still had a fever (102) and chills and redness on arm had increased in size; also headache (predominately in both eyes). I slept a lot during that day. Day 3 low grade fever persisted. Used Tylenol with good results. By day 4 feeling much better!! Redness at injection site increased but less itching and discomfort. Regaining energy.
73 2021-02-07 loss of personal independence in daily activities Arm locked up extreme pain. muscle spasm and cannot lift my arm above my shoulder (which is an impr... Read more
Arm locked up extreme pain. muscle spasm and cannot lift my arm above my shoulder (which is an improvement from the initial condition). Pain was so bad upon movement I thought I was going to pass out. It is improving, day to day, but still incapacitates me from my daily routine.
73 2021-02-07 sleep disorder Itching at injection site in the afternoon of 02/07 then swelling, redness and heat during the nigh... Read more
Itching at injection site in the afternoon of 02/07 then swelling, redness and heat during the night causing sleeplessness. Symptoms continuing now on 02/08 though not quite as bad.
73 2021-02-07 sleep disorder My adverse reaction was about 2-3 hours after I had the vaccine, I expected my arm to be sore but it... Read more
My adverse reaction was about 2-3 hours after I had the vaccine, I expected my arm to be sore but it steadily got more and more sore. It kept waking me up on that night 2/3. I tried not to lay on my left side and I was getting chills like you get when you get the flu, so that lasted for about 30 hours after I had my vaccine. And then about 2:30-3:00 in the afternoon all of the adverse symptoms/reactions I was having just stopped. The only other thing I want to say is that I wasn't hungry at all, i could taste and smell but I didn't want to eat anything. I had soup and everything else but I had no appetite.
73 2021-02-09 confusional state drowsiness, chills, stiffness and soreness all over. 2 inch red blotch appeared at vaccine site abou... Read more
drowsiness, chills, stiffness and soreness all over. 2 inch red blotch appeared at vaccine site about 10 hrs after injection--slight itching. On the second day could hardly get out of bed..very stiff and sore overall, slept most of the day, on awakening I was groggy and confused. Perspired thru the night as though a fever was breaking and when I awoke I felt slight headache but otherwise NORMAL! tHIS WAS THE 2ND DOSE.
73 2021-02-10 anxiety Patient received vaccine at 2PM. Around 2:20 patient reports she is having some anxiety and difficul... Read more
Patient received vaccine at 2PM. Around 2:20 patient reports she is having some anxiety and difficulty breathing. She has found out her tire on her car is flat and she states that is making her worried. I observed patient and she appears to be shaking but no distress noted in breathing. Blood pressure is checked at 2:32 and was 152/92. Patient now states that she normally takes Xanax three times daily and a blood pressure pill daily and she has not taken these medications today because she was coming for her vaccine. At 2:35 she reports her throat feels like it is swelling. 911 is immediately called. Epinephrine 0.5 mg/0.5 ml is given IM in patients right deltoid at and patient is placed on 4 liters of 02 by nasal cannula at 2:39. Patient reports at 2:43 that her throat does not feel as tight. Blood pressure is re-checked at 2:44 and is 148/86. Patient states she feeling dizzy, but her throat does not feel like it is closing. Ambulance arrived at 2:50 and resumed care of patient. Patient denies transport and leaves with grandson walking to their personal vehicle and appears in stable condition.
73 2021-02-10 feeling abnormal 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 2021-02-11 restlessness Pt reports got vaccine on 1/30. Reports severe itching and restlessness, severe body aches, fevers u... Read more
Pt reports got vaccine on 1/30. Reports severe itching and restlessness, severe body aches, fevers up to 102, sore throat. Symptoms were still present at time of televisit on 2/10. Influenza A/B, RSV, COVID and strep testing negative. Pt has history of severe reaction to flu shot resulting in hospitalization years ago
73 2021-02-11 sleep disorder woke with uncontrollable itching, hives or welts, from ankles to head, knees, inside thighs, outsid... Read more
woke with uncontrollable itching, hives or welts, from ankles to head, knees, inside thighs, outside thighs, buttocks, fingers, by underarm pits, chin, eyes, top of legs between knees and torso, urgent care at urgent care, Dr. concluded it was from vaccine, gave me 3 pills of some type of cortisone , and 4 day course of cortisone tablets next four days, also OTC benedryl, to allow me to sleep
73 2021-02-13 insomnia Sensitive skin all over Heat soreness at site Slight light headed ness Muscle aches Sleeplessness
73 2021-02-13 sleep disorder 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 feeling abnormal I actually had COVID-19 back in November and my reaction to the Moderna first shot was twice as bad ... Read more
I actually had COVID-19 back in November and my reaction to the Moderna first shot was twice as bad as the initial COVID-19. I was very weak, lethargic, unable to move quickly and basically felt like crap. It is now two days later and I still feel badly. It makes me truly wonder if I should take the second shot. I?ve heard that it?s the worst one and I can?t imagine feeling worse than I did the day after the initial shot. I?ve heard that they?ve had a problem with people coming in for the second shot and now I totally understand why. I would appreciate some sort of response to this.
73 2021-02-15 emotional distress, anxiety Anxiety distress. EmS evaluate calm person down went home
73 2021-02-15 sleep disorder Awoke at 1:34 AM and my left foot hurt. I had a marble-size lump and a few small lumps on the verti... Read more
Awoke at 1:34 AM and my left foot hurt. I had a marble-size lump and a few small lumps on the vertical bone above my heel that were tender to the touch. My foot on top was slightly swollen and shiny and red on the side and both were tender to the touch. I massaged my foot and went back to sleep. When I awoke the marble-sized lump was much smaller. I got up, ate, and in the afternoon after research, I realized it was gout and I had tophi for the first time ever. I had my first gout flare in November 2003 without tophi, and never had another flare until 2/14/2021! I walked and suddenly my Achilles? tendon hurt and my heel hurt a little. I took 2 Colchicine and took one more an hour later. It seemed much better and didn?t hurt but some of the pain returned. I couldn?t sleep until 4:05 AM and awoke around 6 according to my Fitbit watch. I contacted my doctor and he said to take one Colchicine every day until the pain is gone.
73 2021-02-16 delirium High fever began about 8 hours after injection. Delirious weak headache muscle & joint aches. Slept ... Read more
High fever began about 8 hours after injection. Delirious weak headache muscle & joint aches. Slept for 24 hours. Fatigue continues but getting better. Headache still be getting better. Arm got very red hot & itchy on day 3.
73 2021-02-17 confusional state weakness to right side, fever, increased confusion,
73 2021-02-17 feeling abnormal pt stated that a couple of hours after the vax she had arm pain and when she woke up next day she ha... Read more
pt stated that a couple of hours after the vax she had arm pain and when she woke up next day she had chills, headache and felt bad. She took her temp and it is 100.4. Pt has not contacted her PCP at this time but will if her symptoms persist.
73 2021-02-17 sleep disorder I had been positive for a COVID 19 test in late November and hardly had any symptoms and when I got ... Read more
I had been positive for a COVID 19 test in late November and hardly had any symptoms and when I got the vaccine I has body aches headache my skin hurt I couldn?t sleep.
73 2021-02-18 sleep disorder Woke up Tuesday at 11PM crying with pain on the right side of my back. After pain and crying for 2 ... Read more
Woke up Tuesday at 11PM crying with pain on the right side of my back. After pain and crying for 2 hours fell asleep. OK when I woke up. Woke up Wed. at midnight crying with pain on the right side and mid area of back. Fell asleep after 2 hours. OK when I woke up. Pain not as severe as Tuesday night. Woke up Thursday at 11 pm with pain. Not severe and was able to go back to sleep. Pain Tuesday night was an 8. Pain Wed night was a 7. Pain Thursday night was a 3.
73 2021-02-19 sleep disorder Around midnight I began experiencing body aches that woke me up and prevented me from sleeping. I t... Read more
Around midnight I began experiencing body aches that woke me up and prevented me from sleeping. I took my temperature and had a fever of 101.1. I took tylenol. I had the same sypmtoms the following day and continued to take tylenol 325 mg until around dinnertime when the aches and fever diminished and then were gone. I also have a red, warm, itcy patch around the site of the injection.
73 2021-02-20 feeling abnormal COVID-19 vaccine given. Second day heart and chest felt funny. Can?t describe. Third day had vertig... Read more
COVID-19 vaccine given. Second day heart and chest felt funny. Can?t describe. Third day had vertigo, nausea, and chills. Fourth day pretty good. Fifth day had vertigo, nausea and chills again. Sixth day, today, doing pretty good. Started ginger for vertigo yesterday and sprite.
73 2021-02-20 sleep disorder, nightmare On the night of Feb. 8, 2021 I had a hallucinogenic nightmare that woke me up.
73 2021-02-21 mental impairment 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 poor quality sleep At about 2 pm, 2-19-2021, I became very light-headed rather suddenly, and could barely stand up or w... Read more
At about 2 pm, 2-19-2021, I became very light-headed rather suddenly, and could barely stand up or walk. (A trip from my bed to the bathroom was difficult.) This proceeded to severe nausea (I retched into the. toilet bowl a couple of times and came close to vomiting). I dosed in bed and the severity of the symptoms eased, but I really haven't felt completely over it until today (2-22-2021).
73 2021-02-22 feeling abnormal fever, chills, foggy head, nauseated
73 2021-02-23 delirium 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 2021-02-24 crying I got an allergic rash, very itchy and red, with small, clear, weeping blisters about a week after t... Read more
I got an allergic rash, very itchy and red, with small, clear, weeping blisters about a week after the shot (after the initial redness and swelling from the shot had subsided).
73 2021-02-24 hallucination, mental status changes 5-8 hours post injection, intense headache, sore arm, dizziness. 12 hours post injection, fever, swe... Read more
5-8 hours post injection, intense headache, sore arm, dizziness. 12 hours post injection, fever, sweats, neck pain on left side. 15 hours post injection, altered mental state - hallucinations - nausea - weakness - higher fever - intense thirst. 24 hours post injection, altered mental state cleared, weakness, fever, & nausea continued. 30 hours post injection, able to drink clear liquids. Fatigue, weakness, headache, body ache, intermittent fever remained. 48 hours post injection, headache subsided, mental clarity returning, fatigue & intermittent fever remain.
73 2021-02-26 anxiety Swollen lymph nodes on left side/breast identified in mammograms, ultrasound and MRI. You need to w... Read more
Swollen lymph nodes on left side/breast identified in mammograms, ultrasound and MRI. You need to warm women to delay mammograms until a month after second dose. Anxiety, unnecessary tests and expense.
73 2021-02-26 confusional state 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 sleep disorder 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 2021-02-27 feeling abnormal At 4:00 PM noted inside of lips felt bumpy. Later tongue felt weird and looked in mirror and saw red... Read more
At 4:00 PM noted inside of lips felt bumpy. Later tongue felt weird and looked in mirror and saw red lines on sides of my tongues. Lips burned. Later sides of tongue bumpy.
73 2021-02-27 insomnia bone pain muscle cramps joint pain pleuritic pain stomach pain sleeplessness
73 2021-02-27 mental status changes Onsite EMS evaluated patient ad determined that she was light-headed, responsive, but not lucid. Pat... Read more
Onsite EMS evaluated patient ad determined that she was light-headed, responsive, but not lucid. Patient was transported to medical center.
73 2021-02-27 sleep disorder Injection hurt going in and pulling out. Soreness excruciating at 10:30 pm. Couldn?t sleep. Felt rea... Read more
Injection hurt going in and pulling out. Soreness excruciating at 10:30 pm. Couldn?t sleep. Felt really tired starting at 10:30 At 8am had 100.7 fever. Felt weak, fluey and lightheaded. Legs wobbly when getting out of bed. Stayed in bed til 3 pm when Temp 99.7. Started feeling better at 6 pm. Got up. Arm still sore. Next day still felt light headed but temp normal. Developed a sore 2x3 inch bump on inside of my left arm that is sore. Doctor said injection hit a blood vessel and I have a hematoma Injection site soreness almost gone Inexperienced young girl gave me vaccine. Really hurt unlike the first shot which didn?t even hurt. Think she needs more training on how to administer injections
73 2021-02-28 feeling abnormal After 15 min. (4:10 p.m.) I left the Dr. office to go to the store in the same town. While there (... Read more
After 15 min. (4:10 p.m.) I left the Dr. office to go to the store in the same town. While there (about 4:15 p.m.) I started a bad headache, neck hurt and feeling "strange". While waiting in the check out line I felt hot and weak. After a few min. when I got home ( about 5:15 p.m.) my face felt tight and I became itchy on all parts of my body except not as much on my legs. The next day the headache was not as bad but still itchy especially on my face, head and back. My arm was not any more sore than with a flu shot. The next day the headache was gone, the arm was not sore, but I was still itchy. The itching would come and go for about a week.
73 2021-02-28 impaired work ability 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 sleep disorder Next day reaction included severe chills, body aches, headache, earache, several bouts with diarrhea... Read more
Next day reaction included severe chills, body aches, headache, earache, several bouts with diarrhea, pain in right side of neck, elevated temperature 99.2 ( usual temp ranges between 97.2-97.7) Symptoms began approximately 11:30 am - took Tylenol about 1 PM - by 5:30PM felt better. Had a light dinner and by 10:30PM symptoms started again. Took Tylenol again and went to bed. Did not sleep well- next day very fatigued with a queasy stomach at time of this report still an elevated temp of 99.2.
73 2021-03-01 fear Patient came in for her second vaccine and complained of her arm still hurting from the first vaccin... Read more
Patient came in for her second vaccine and complained of her arm still hurting from the first vaccine. She also complained of chills and fever.
73 2021-03-03 disturbance in attention Patient states she was weak, and couldn't feel her arms or legs about an hour after getting her COVI... Read more
Patient states she was weak, and couldn't feel her arms or legs about an hour after getting her COVID 19 vaccine. States on the way home she ended up on the wrong side of the road and felt like she wasn't focused and this progressed to numbness. States that when she went to get out of her car she had a fall and is unsure if she passed out or just fell. States these symptoms lasted 3-4 hours but it gradually improved. States almost all symptoms had improved by the next day.
73 2021-03-04 disorientation, memory impairment 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 feeling abnormal, excessive sleepiness, loss of personal independence in daily activities 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 2021-03-04 feeling abnormal 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 2021-03-05 feeling abnormal, anxiety, agitation 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 2021-03-05 sleep disorder About 10 hours after shot, my whole upper arm was swollen and VERY tender. I could not lay on it wh... Read more
About 10 hours after shot, my whole upper arm was swollen and VERY tender. I could not lay on it when I slept. If I tried to in my sleep the pain would awaken me. The next day after my shot at about 10 AM I began to feel wonky (dizzy) and tired. For the entire rest of the day I had to literally lay around which is unusual for me as I'm very active. I was too tired to do anything--extreme fatigue. The night was the worst. I had a fever and sweats and horrible dry mouth. I woke up about 3 times an hour throughout the night because of the dry mouth and had to drink water. I drank three 16 fl oz bottles of water. I had to urinated 5 times in the night. [normal for me is I never wake to urinate. I go to bed about 11 pm and wake up at 7. Today I feel normal except my arm is still tender from the shot.
73 2021-03-06 confusional state, excessive sleepiness The fatigue has only gotten worse 3 days out from 2nd shot. Also, it feels like I have been drugged ... Read more
The fatigue has only gotten worse 3 days out from 2nd shot. Also, it feels like I have been drugged & have slept 14 hrs & still extremely tired. Also, mental confusion
73 2021-03-06 sensation of foreign body Eyrothema , swelling, tenderness 4 "diameter x 6" long..extending to top of arm. Fatigue. Exercise i... Read more
Eyrothema , swelling, tenderness 4 "diameter x 6" long..extending to top of arm. Fatigue. Exercise intolerance. Nausea. Enlarged submandibular lymph glands. Feeling of "something in throat. Ibuprofen 200 mg. Rest. May add Benadryl 25 mg
73 2021-03-07 confusional state, amnesia sore arm headache weakness dizziness mental confusion loss of memory All started morning of 3-6-21 ... Read more
sore arm headache weakness dizziness mental confusion loss of memory All started morning of 3-6-21 except altered mental state which started around 2 pm on 3-6-21. The confusion lasted all night. Other effects are better but still present especially the weakness.
73 2021-03-07 confusional state 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 2021-03-07 excessive sleepiness Overly exhausted; deep muscle tension and aches: bad headache, frontal and temporal, slept deeply 12... Read more
Overly exhausted; deep muscle tension and aches: bad headache, frontal and temporal, slept deeply 12 hours while normal is 5 hours; ravenously hungry for hot soup, ate 1 meal that day in the evening. Same complaints on day/night 2. Awoke feeling fine little tiredness day 3. Never any fever.
73 2021-03-07 mental status changes Alzheimers patient - these were new symptoms that were not there before the vaccination. woke up an... Read more
Alzheimers patient - these were new symptoms that were not there before the vaccination. woke up and could not keep her balance. Unable to walk or sit up without assistance. Unusually unaware of husband or surroundings. Have not sought medical treatment yet.
73 2021-03-07 sleep disorder The day she got the shot she woke up with excruciating pain in the back of her neck. now has a heada... Read more
The day she got the shot she woke up with excruciating pain in the back of her neck. now has a headache and pain is between shoulder blades and down back of neck. received vaccine on 2/20/20. has been taking Tylenol every 4 hours and is not helping. Symptoms were so bad when they started woke her up, she hurts all the time. Denies any numbness or tingling. Wants to note she had cancer, last January had a lumpectomy and radiation treatments.
73 2021-03-08 agitation Unknown Vaccine Brand; This patient is a 73 y.o. female, who received her first COVID-19 vaccine 2 d... Read more
Unknown Vaccine Brand; This patient is a 73 y.o. female, who received her first COVID-19 vaccine 2 days ago, presenting to the emergency department with a chief complaint of right sided neck swelling. She attributes this to her vaccine. Immediately after receiving the vaccine she felt completely fine without any side effects. One night ago she began to feel like she was getting an ear infection with some pain and pressure to her right ear. Today, she noticed some swelling to the right side of her neck. She also feels dehydrated as she has not been eating or drinking much. Additionally, she endorses some agitation last night.
73 2021-03-08 insomnia 1st a sense of vertigo, 3/6 not dizzy, able to function, but vertigo, and difficulty sleeping. the ... Read more
1st a sense of vertigo, 3/6 not dizzy, able to function, but vertigo, and difficulty sleeping. the next day 3/7 body aches, fever/chills, then severe lower back pain that made it hard to move without pain; i believe my kidneys were expressing the difficulty of processing the vaccine. 3/8 all symptoms continue at lower intensity. 3/9 lower back pain much decreased, some sense of vertigo or it's remnants. this is the first day i haven't felt like "death warmed over"...just tired and feeling like i've been through an intense flu.
73 2021-03-08 loss of personal independence in daily activities Pt has a set back in rehabilitation. Pt was unable to stand w/out 2 person assist, unable to shower... Read more
Pt has a set back in rehabilitation. Pt was unable to stand w/out 2 person assist, unable to shower self, dress self. or put in her hearing aids. Unable to perform task she was able to do before the vaccine dose. She had periods of staring and slow response to staff.
73 2021-03-08 mental impairment 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 2021-03-10 feeling abnormal The shot hurt when administered, didn't feel the first one. About 2 minutes after shot, felt light h... Read more
The shot hurt when administered, didn't feel the first one. About 2 minutes after shot, felt light headed and like the shot contained adrenalin or epinephrine. That subsided by the time I left the site, although I remained slightly light headed all evening. Went to bed at 10:00 with an extremely sore arm, beginning of body aches and fever of 99.3. Awoke at 1:00am with 101.9 temp, extreme muscle and joint pain, and every time I moved anything, even a finger I would feel the sensation of a chill or slight electric shock. Urinated every hour from 1:00am and 5:00 am. When I awoke at 5:00 I was so weak, nauseated and dripping sweat I barely got my dog fed and let out for the morning. The nausea passed quickly but I thought I was going to have to lie down on the floor during that wave.Went back to bed, slept until 7:00 and was pretty much a zombie until 6:00pm last night(March 10) when all exhaustion and muscle pain disappeared and I have been fine since then.
73 2021-03-10 excessive sleepiness, euphoric mood Gross muscle and tendon and cartiledge pain. I have bad side effects from taking motrin, ipuprofen,... Read more
Gross muscle and tendon and cartiledge pain. I have bad side effects from taking motrin, ipuprofen, asprin, etc. I did camomile, a couple of times did the colchicine in case the shot ingredients were making that click in.... but aspects of this was worse. And I did some CBD during the day sometimes. Still did the gaba and CBD at night. Sometimes the pain was so bad it burned. Bad heache that got worse with concentration, extremely dry eyes that eye drops didn't help, gastric problems worse than I'm used to, ate less. I worried about long term leftover inflammation. things are much better now, but still get the heache at a lower level off and on. From old injuries, my muscles are weaker because I've rested too much. My need to sleep was extreme and I was taking long naps during the day and sleeping at night. That happened even when I wasn't taking the daily time CBD. It has been three weeks now and the pain is 99% gone. I can concentrate better. Etc. I also want to report something many of my friends are reporting... and that is a sense of euphoria after the shot. I also had that. BUT I know that that can be caused by a kick into effect of hormones. And I think one or more of the ingredients are apt to cause that (like the hydrocarbons/plastics). they can serve as synthetic hormones. People are thinking that the euphoria was psychological because of relief. I know better and I want this explained to people. It is not ok to let them believe this.
73 2021-03-13 sleep disorder Moderna COVID-19 Vaccine EUA Symptoms: 100.2 fever, chills, total body aches, extreme fatigue, mild... Read more
Moderna COVID-19 Vaccine EUA Symptoms: 100.2 fever, chills, total body aches, extreme fatigue, mild nausea (no vomiting), lack of appetite. Could not sleep on left side due to pain, swelling at the injection site. Treatment: Dr. recommended Tylenol or Advil. I took one High strength Tylenol at 11:00 AM and an Advil at 8:30 PM when I went to bed. Duration: Symptoms began at 2:00 AM (14 hours after injection) but subsided that night. I felt great the next morning.
73 2021-03-14 confusional state Head Pain Noise Pressure Confused Difficult recalling words
73 2021-03-14 confusional state Approximately 10 hours after the injection I began having chills so bad I could not hold onto anythi... Read more
Approximately 10 hours after the injection I began having chills so bad I could not hold onto anything, then my temperature began to rise. I went to bed at 9:00 pm bundled up with numerous blankets, clothes, etc. . My neck, lower back ached then a terrible headache set in. I took motrin, acetaminophen then an Aleve migraine pill. The migraine pill seemed to be the only thing that helped with the headache. I was too tired, sore and weak to get out of bed until 11:00 the next day - The headache returned about 3:00 p.m on Saturday so I took another migraine pill. Needless to say I was extremely fatigued and probably confused. On Sunday morning I had multiple bowel movements - my ibs had been under control until this.
73 2021-03-14 nervousness extreme nervousness
73 2021-03-16 excessive sleepiness Fatigue-slept all day Sunday, March 14 except for about 2 hours. Woke for brief periods, then went ... Read more
Fatigue-slept all day Sunday, March 14 except for about 2 hours. Woke for brief periods, then went back to sleep. Nausea, chills and very, very slight headache. Symptoms lasted until about noon Monday, March 15.
73 2021-03-16 panic attack Right eye couldn't focus, horrible headache, asthma attack/panic attack, trouble walking with right ... Read more
Right eye couldn't focus, horrible headache, asthma attack/panic attack, trouble walking with right side (all on day of shot couple hours after shot), fever and chills overnight, Friday: lip pain, headache continue, trouble walking/pain in legs continue through Saturday.
73 2021-03-16 sleep disorder Migratory pain in all joints and muscles for approx 8 hrs followed by exhaustion and muscle pain for... Read more
Migratory pain in all joints and muscles for approx 8 hrs followed by exhaustion and muscle pain for 24 hrs. Pain on day 2 , 3/16 was greater in lower back and hips. Residual muscle soreness and weakness on 3/17. Initial pain jumped from joint to joint . Intense enough to prevent any sleep. Out of commission for 36 hrs.
73 2021-03-18 confusional state 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 2021-03-18 disorientation Shortly after the injection Pt experienced disorientation. (Received the vaccine at 0900 and disori... Read more
Shortly after the injection Pt experienced disorientation. (Received the vaccine at 0900 and disorientation happened later that morning. Saturday February 27, 2021 experienced muscle weakness and pain. This progressed into the inability to stand or walk. Seemed to migrate up the ankle and into the legs. Was confined to a wheelchair for a few days. Was being seen daily or every other day by APRN who works with Dr. By March 10, 2021 was able to stand with a walker. Was improving daily. Talked with Pt on March 15, 2021 and she is now walking without any assistance and feels back to normal
73 2021-03-20 feeling abnormal 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 anxiety 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 feeling abnormal 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 feeling abnormal Headache the first and second day following injection. Brain fog began day following injection and ... Read more
Headache the first and second day following injection. Brain fog began day following injection and was very noticable the first week or week and a half and has not completely gone away to this day.
73 2021-03-22 confusional state Severe lethargy after receiving the shot. Constant sleepiness and malaise, nausea, confusion, loss ... Read more
Severe lethargy after receiving the shot. Constant sleepiness and malaise, nausea, confusion, loss of appetite, dizziness, Blood vessels/clots formed in her eyes. Acute renal failure and eventually death on March 18, 2021.
73 2021-03-22 disturbance in attention, nightmare, loss of personal independence in daily activities After Moderna Dose #1 Within one day of vaccination the person experienced extreme fatigue, muscle w... Read more
After Moderna Dose #1 Within one day of vaccination the person experienced extreme fatigue, muscle weakness, joint achiness, headache, and nausea. She felt feverish and chilled but had no fever. She noted nightmares , hard to focus, eye sensitivity, abdominal pain and about 10days after vaccination had an episode of thick saliva and drainage so that she had to sleep upright. These symptoms progressed for about a week and then slowly resolve completely by about 3 weeks post vaccination. After Moderna Dose #2 - RN spoke with client 1 week after dose #2. Within one day of vaccination she experiences intense fatigue, headache on day 2, light sensitivity, body aches in joints and muscles, her arm felt hot, swelling of her breasts, no appetite, and abdominal pain, She did NOT experience any rashes or itching or difficulty breathing. Her symptoms were so incapacitating that she could not do any of her ADL's and could only relieve her pain by lying down in bed all day. As soon as she tried to move around the intense joint pains returned and she had to lie down. Normally she treats her arthritis with Colchicine as needed but received no relief. After a few days she did try one dose of Allegra (antihistamine) with some relief. Resting by lying down in bed for a week has been her only relief. She did not indicate any allergies to PEG.
73 2021-03-22 feeling abnormal I had my shot at 4:00 PM on March 17th. I woke up about 11:00 PM with a bad headache, chills, fever... Read more
I had my shot at 4:00 PM on March 17th. I woke up about 11:00 PM with a bad headache, chills, fever. I had no appetite, was tired and my head felt foggy. The next morning I started breaking out with hives on my forehead, neck, upper back and chest. I had chills and fever again the next day. My hives finally started to subside on Sunday the 21st.
73 2021-03-23 feeling abnormal, amnesia 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 2021-03-23 sleep disorder, loss of personal independence in daily activities On 3/22/21, date of vaccination, my left arm (shot taken) was more than sore. I could hardly lift i... Read more
On 3/22/21, date of vaccination, my left arm (shot taken) was more than sore. I could hardly lift it. I had to hold it as if it were in a sling. I had chills that evening and couldn't sleep. The left side of my neck, behind my ear, is sore. On 3/23/21, my left arm was still very sore but better. I had a temperature of 101. My neck is still sore. I was able to sleep a little better that evening. Today, 3/24/21, my left arm is slightly sore. I can raise it up a little without pain. My neck is still sore. Symptoms are much better today.
73 2021-03-24 confusional state 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 confusional state disoriented, completely confused; sort of non-verbal; weak; tired; shivers; A spontaneous report wa... Read more
disoriented, completely confused; sort of non-verbal; weak; tired; shivers; A spontaneous report was received from consumer concerning a 73-year-old, female patient, who experienced being weak/asthenia, disorientated,completely confused/confusional state, tired/fatigue, shivering/chills and was sort of non-verbal/speech disorder. The patient's medical history was not provided by the reporter. The relevant concomitant medication use were not reported. On 10 Mar 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number:unknown) intramuscularly for prophylaxis of COVID-19 infection. On 11 Mar 2021, patient felt weak and tired. On 13 Mar 2021 the patient was completely confused, disoriented, sort of non-verbal, and had shivers. She was hospitalized that day and was diagnosed with a stroke. On 15 MAR 2021, the doctors removed the diagnosis of stroke but were unsure of what it was. The treatment for the events included acetaminophen, metoprolol, losartan and nexium. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, weak/asthenia, disorientated,completely confused/confusional state, tired/fatigue, shivering/chills and was sort of non-verbal/speech disorder 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 insomnia 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 2021-03-25 agitation, insomnia Initially I felt agitated after injection almost immediately. That evening and every evening since I... Read more
Initially I felt agitated after injection almost immediately. That evening and every evening since I have had but I am going to call insomnia. Unable to fall asleep unable to stay asleep. In addition my arm still aches at day 13, sort of the touch and I would describe it adult ache.
73 2021-03-25 disturbance in attention Initially very mild muscle aches and fatigue. 3 to 4 days later there was weight gain of 3 pounds an... Read more
Initially very mild muscle aches and fatigue. 3 to 4 days later there was weight gain of 3 pounds and edema most obvious to the upper eyelids. This worsened with itching and pain to eyes. Additionally I had difficulty focusing my mind and a general feeling of being ?unwell?. Benadryl 60 mg reduced the eye discomfort. Contacted providers? office, but have not heard back.
73 2021-03-25 insomnia 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 2021-03-26 hallucination Hallucinations
73 2021-03-27 amnesia 3/25/21. awoke dizzy, unable to walk properly, phantasmic visions, headache, eventually bowel urgenc... Read more
3/25/21. awoke dizzy, unable to walk properly, phantasmic visions, headache, eventually bowel urgency (not exactly diarrhea) violent vomiting (and stress incontinence, very unusual for me), return of rapid strange mental images and rapid eye movements, and five hours completely lost, possibly sleeping, again the headache and neck ache (which might've been positional?) 3/26/21. just able to drive for a COVID test (because I work, I thought I should rule it out), eventually able to tolerate liquids, but other wise in bed all day 3/27/21. in bed all day til 4 pm, still light headed, but able to tolerate food (rice, avocado, tea) after 32-36 hours, went out to practice motion and fighting gravity/blood pressure (because going to work Sunday) 3/28/21. a bit weak still, eating simply, lightly, little - went to work (church organist, Palm Sunday), back in bed saving energy for week-day job (librarian) and planning to be better very soon
73 2021-03-28 disturbance in attention 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 2021-03-28 feeling abnormal "cognitive fog" Five days after 2nd Moderna shot, I started to work at my computer, and, in my brai... Read more
"cognitive fog" Five days after 2nd Moderna shot, I started to work at my computer, and, in my brain, I felt like I was swimming through molasses. For 2 days after, the "fog" lessened. Since then, no change: not worse and not better.
73 2021-03-29 feeling abnormal tinnitis, weak fatigue, brain fog, eyes blur, NV and diarrhea at the start, arm sore and rash over a... Read more
tinnitis, weak fatigue, brain fog, eyes blur, NV and diarrhea at the start, arm sore and rash over a week
73 2021-03-29 impaired work ability Chills, fever, migraine like headache for 3 days, sensitivity to light, flu like symptoms. Unable ... Read more
Chills, fever, migraine like headache for 3 days, sensitivity to light, flu like symptoms. Unable to work for 3 days and still not feeling well until 3/20/21 which was almost a week after the second shot. Got really dehydrated and had muscle aches. Actually went for a covid test which was negative.
73 2021-03-29 nervousness Felt Shaky and flushed about 15 minutes after vaccine. Given pretzels and waters and relaxation tech... Read more
Felt Shaky and flushed about 15 minutes after vaccine. Given pretzels and waters and relaxation techniques were discussed. Feeling better after 30 minutes. Still feeling a little shaky. Got an order from a provider to check BG, which was 124 after the pretzels. Patient felt okay, spoke to PCP and was okay to leave the office. Note from MD was that patient likely experienced a vasogagal response. Observed for about 45 minutes total.
73 2021-03-30 hallucination, delirium Mild Heart attack, hospitalization, delirium, hallucinations.
73 2021-03-30 sleep disorder 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 amnesia, delirium delirious/uncontrolled laughing; loss of memory; 102 F fever; pied on self; dizzy; headache; A spont... Read more
delirious/uncontrolled laughing; loss of memory; 102 F fever; pied on self; dizzy; headache; A spontaneous report was received from a Consumer, concerning herself of 73 years old female, who received Modena's COVID-19 vaccine, and experienced headache, delirious/uncontrolled laughing, 102F fever, lost memory, peed on self, dizziness. The patient's medical history was not provided. Concomitant medication included Gabapentin for pain 80 mg 3 times a day, Amlodipine, Esomeprazole twice a day 40 mg, Furosemide 40 mg 2 in the morning, Citalopram 20 mg, Pentosan polysulfate 100 mg 3 times a day, Renoxin 1000 mg twice a day, potassium 20 mq twice a day, Atorvastatin twice a day, Trazodone 150 mg once a day, Linaclotide once in a while 290 mcg, vitamin D once a week, Clonazepam twice a day, Diphenhydramine, Alirocumab injection. On 03 FEB 2021, the patient received their first of two planed doses of mRNA-1273 (Batch number 012M20A) on right non-dominant arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, 2 days after vaccination, the patient had headache and a day after had memory loss and fever ranging from 102 to 103, pied on self, dizzy, uncontrolled laughing and delirious, all of which lasted for 3 days but treated only for headache. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events were reported as resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
73 2021-04-02 feeling abnormal 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 2021-04-02 sleep disorder Woke in middle of night with bad headache and body/joint aches. All next day was extremely fatigued.
73 2021-04-04 feeling abnormal Itchy rash, eventually spreading to most of the body (all except hand,feet,stomach,lower back.) Bega... Read more
Itchy rash, eventually spreading to most of the body (all except hand,feet,stomach,lower back.) Began on upper chest and upper back, spreading to neck, face, forehead. LIDEX(fluocinonide) used sparingly. Rash totally covered these areas and lasted approximately 10days-2 weeks, leaving scaly skin. Dry eyes, very dry mouth. Rash spread to upper arms, thighs (both were less dense than other areas, less itching) Finally spread to lower arms and lower legs. All rashes and itchiness cleared approximately 4 weeks after first rash appeared (or 5 weeks anfter 2nd dose) Size and color or hands differed after 2nd dose (uncertain dates for this obser For approximately 2 weeks, left hand noticably fuller and redder than right.
73 2021-04-04 feeling abnormal First day extreme lethargy and brain fog. Second day temperature 2.5 degrees above normal, aching al... Read more
First day extreme lethargy and brain fog. Second day temperature 2.5 degrees above normal, aching all over, mild headache, extreme fatigue and lethargy, very sore arm, much worse than first day. Third day most okay except the sore arm. Today mostly okay but feeling a little strange and slightly dizzy. I?m never sick and would never do the moderne vaccine again. Maybe Johnson and Johnson if we have to do this again.
73 2021-04-05 feeling abnormal itching and redness going down arm, naseau, headache, head fog 50mg Benadryl
73 2021-04-05 loss of personal independence in daily activities Sore arm, very thirsty, not hungry, diarrhea, dizziness, fatigue, lack of strength, uncoordinated an... Read more
Sore arm, very thirsty, not hungry, diarrhea, dizziness, fatigue, lack of strength, uncoordinated and jerky motions. Needed assistance to move around at home. Even to sit and stand. All of these symptoms for 2 days.
73 2021-04-06 feeling abnormal 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 feeling abnormal Patient received the Covid-19 vaccine. She reports symptoms of {Immediate reaction less than 1 hour}... Read more
Patient received the Covid-19 vaccine. She reports symptoms of {Immediate reaction less than 1 hour}. I have observed 0920 patient c/o dizziness, skin warm and dry, color pink,states took b/p medication this am, had breakfast, did have a slight upset stomach prior to coming. B/P 172/74 (pt states that is slightly elevated for her), P 74, SpO2 99, regular resp, states history of atrial fibrillation, does not feel that is active at present. 0934 B/P 154/72 symptoms of dizziness and fogginess persist, legs feel weak/numb*** Treatment/intervention water given, mask removed, cool compress to back of neck. Decision made at 0934 to proceed to ED via wheelchair for observation and evaluation.
73 2021-04-06 sensation of foreign body Immediate histamine reaction after shot (post nasal drip, sore throat, feeling of lump in throat). I... Read more
Immediate histamine reaction after shot (post nasal drip, sore throat, feeling of lump in throat). Immediate soreness in arm at injection site. Symptoms lasted 3 days. Rash and itching at injection site 2.5 weeks after vaccine. Symptoms lasted 3 days
73 2021-04-07 feeling abnormal 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 2021-04-07 loss of personal independence in daily activities On 03/29/2021 reaction started at injection site, gastrointestinal moderate to severe, abdominal pai... Read more
On 03/29/2021 reaction started at injection site, gastrointestinal moderate to severe, abdominal pain, body aches, no temp. This continued throughout the week of 03/21/2021. Extreme fatigue to the point that I had to stay in bed and sleep. Reaction site swelled to the size of a small child's Nerf football with weals and severe itching. Coughing and nasal congestion started on 04/01/2021. Severe fatigue continued. Was able to do small chores, but my husband took care of most responsibilities. Poor appetite and severe nausea developed 04/02/2021. Time course approximately 14 days. Today, 04/08/2021, swelling is gone at site, still fatigued, but not severe. Will rest and continue to recover.
73 2021-04-09 feeling abnormal The vaccine seemed to be wandering around my body looking for "weak" areas. All of my old injuries t... Read more
The vaccine seemed to be wandering around my body looking for "weak" areas. All of my old injuries that hadn't bothered me for years were affected, but the worst was two broken ribs from years ago. Suddenly I had sharp pain and (sounds like science fiction) it felt like something was moving around rapidly under my skin or hundreds of small spasms in the muscles around the ribs. Very painful. I used the ice pack I was already using on my sacrum and it stopped, including the sharp pain. The business under my skin was extremely weird and frightening. I feel fine right now , but consider myself a science experiment.
73 2021-04-10 feeling abnormal, insomnia neuropathy was really bad/felt worse when sitting and laying; couldn't sleep; felt sick to her stoma... Read more
neuropathy was really bad/felt worse when sitting and laying; couldn't sleep; felt sick to her stomach; felt really bad; injection arm sore; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy was really bad/felt worse when sitting and laying) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 016B21A) 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 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 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection arm sore). On 30-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (neuropathy was really bad/felt worse when sitting and laying) (seriousness criterion medically significant), INSOMNIA (couldn't sleep), ABDOMINAL DISCOMFORT (felt sick to her stomach) and FEELING ABNORMAL (felt really bad). On 31-Mar-2021, VACCINATION SITE PAIN (injection arm sore) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (neuropathy was really bad/felt worse when sitting and laying), INSOMNIA (couldn't sleep), ABDOMINAL DISCOMFORT (felt sick to her stomach) and FEELING ABNORMAL (felt really bad) outcome was unknown. Concomitant medication use was not provided. Treatment information was not reported. This case concerns a 73-year-old female with a serious unexpected event of neuropathy peripheral, and nonserious unexpected feeling abnormal, abdominal discomfort, insomnia, and expected vaccination site pain. 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.; Sender's Comments: This case concerns a 73-year-old female with a serious unexpected event of neuropathy peripheral, and nonserious unexpected feeling abnormal, abdominal discomfort, insomnia, and expected vaccination site pain. 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.
73 2021-04-15 amnesia, disturbance in attention loss of hearing; Body aches; Diarrhea; shortness of breath; Loss of tastes; loss of attention; loss ... Read more
loss of hearing; Body aches; Diarrhea; shortness of breath; Loss of tastes; loss of attention; loss of memory; Breaking of the hair; Blurry vision; Nausea; chills Life Threatening; Fatigue; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (loss of hearing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 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 12-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 DEAFNESS (loss of hearing) (seriousness criterion medically significant), PAIN (Body aches), DIARRHOEA (Diarrhea), DYSPNOEA (shortness of breath), AGEUSIA (Loss of tastes), DISTURBANCE IN ATTENTION (loss of attention), AMNESIA (loss of memory), TRICHORRHEXIS (Breaking of the hair), VISION BLURRED (Blurry vision), NAUSEA (Nausea), CHILLS (chills Life Threatening), FATIGUE (Fatigue) and MYALGIA (muscle aches). At the time of the report, DEAFNESS (loss of hearing), PAIN (Body aches), DIARRHOEA (Diarrhea), DYSPNOEA (shortness of breath), AGEUSIA (Loss of tastes), DISTURBANCE IN ATTENTION (loss of attention), AMNESIA (loss of memory), TRICHORRHEXIS (Breaking of the hair), NAUSEA (Nausea), CHILLS (chills Life Threatening), FATIGUE (Fatigue) and MYALGIA (muscle aches) had not resolved and VISION BLURRED (Blurry vision) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment included were, acetaminophen (Tylenol) and an inhaler. 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.
73 2021-04-15 anxiety, confusional state, disorientation, feeling abnormal, hallucination, mental status changes 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 feeling abnormal EXTREME fatigue,body aches,no appetite,felt out of it,mild HA,NO energy,slept
73 2021-04-15 sleep disorder 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 2021-04-16 confusional state I had an episode of confusion while attempting to speak to my daughter on the phone, approximately 2... Read more
I had an episode of confusion while attempting to speak to my daughter on the phone, approximately 24 hours after my 2nd vaccine shot. I was speaking but not making sense. I recognized that I was speaking but did not understand what I was attempting to communicate. It alarmed my daughter and 911 was called. A stroke was ruled out by paramedics and I was then transported to the ER for further assessment. I was admitted for further testing and observation because I kept going in and out of a fugue state.
73 2021-04-19 insomnia Fatigue, sleeplessness, chills (brief). Intermittent sharp headache pain on left side near left ear,... Read more
Fatigue, sleeplessness, chills (brief). Intermittent sharp headache pain on left side near left ear, continuing.
73 2021-04-20 feeling abnormal After the vaccination, and while in the hospital, she was diagnosed with a blood clot in the left at... Read more
After the vaccination, and while in the hospital, she was diagnosed with a blood clot in the left atrium the size of a golf ball; Reported she was diagnosed with a spontaneous peptic ulcer bleed; Stated that she feels like she is "sitting on a powder keg"; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ATRIAL THROMBOSIS (After the vaccination, and while in the hospital, she was diagnosed with a blood clot in the left atrium the size of a golf ball) and PEPTIC ULCER HAEMORRHAGE (Reported she was diagnosed with a spontaneous peptic ulcer bleed) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 211M28-9) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart failure (7 years ago- consumer reported it resolved on its own but was placed on Entresto at that time) in 2014 and Arterial stent insertion (Left atrial appendage closure device to treat atrial fibrillation and prevent clots) in 2019. Concurrent medical conditions included Arthritis, Cardiac disorder NOS (Body aches), Headache, Fluid imbalance (Fluid in feet), High cholesterol, Hypotension and Pain. Concomitant products included CARVEDILOL (COREG), HCTZ, VITAMIN C [ASCORBIC ACID], ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN) and PARACETAMOL (TYLENOL) for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-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 ATRIAL THROMBOSIS (After the vaccination, and while in the hospital, she was diagnosed with a blood clot in the left atrium the size of a golf ball) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced PEPTIC ULCER HAEMORRHAGE (Reported she was diagnosed with a spontaneous peptic ulcer bleed) (seriousness criterion medically significant) and FEELING ABNORMAL (Stated that she feels like she is "sitting on a powder keg"). The patient was hospitalized from 24-Feb-2021 to 12-Mar-2021 due to ATRIAL THROMBOSIS. At the time of the report, ATRIAL THROMBOSIS (After the vaccination, and while in the hospital, she was diagnosed with a blood clot in the left atrium the size of a golf ball), PEPTIC ULCER HAEMORRHAGE (Reported she was diagnosed with a spontaneous peptic ulcer bleed) and FEELING ABNORMAL (Stated that she feels like she is "sitting on a powder keg") outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Echocardiogram: results are not mentioned (Inconclusive) Results are not mentioned. The patient stated that she initially was being cared for by a small, local hospital but was transferred to a larger hospital. The patient reported that she has never had any blood clots until now. Treatment for the event included apixaban (twice daily). 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. This case was linked to MOD-2021-075865 (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.
73 2021-04-22 feeling abnormal Client stood up to make 2nd dose appointment, she stated "Where am I? I feel funny." She was escorte... Read more
Client stood up to make 2nd dose appointment, she stated "Where am I? I feel funny." She was escorted to the observation area to lie down. Vitals stable. Clients friend arrive to observation area and informed us that client has history of seizures and takes daily Keppra. Clients friend stated" she becomes confused, stares off, and doesnt know where she is" Client is seeing a neurologist for seizures. Client was able to provide home, DOB, address, phone number, etc. Clients friend stated "I will drive her home" Vitals stable. Client was escorted out to car with friend at 10:45am
73 2021-04-22 insomnia 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 sleep disorder I had aches all over 2 days after 2nd vaccination on 4/5/21. Within a week, I had constant pain in ... Read more
I had aches all over 2 days after 2nd vaccination on 4/5/21. Within a week, I had constant pain in my left knee and a little in my right. I'm in constant pain which is not relieved with Tylenol, ice or heat compresses, epsom baths, light exercise, or stretching. At night I have trouble sleeping because my knee is so painful. Several times I've almost fallen. My lower back is also bothering me because I can't walk normally and am putting even pressure on my knees, legs, and back. Prior to the second shot, I was having this kind of ongoing pain. It has severely limited my ability to get around and I often use a cane so I won't fall.
73 2021-04-23 confusional state, impaired work ability Started with fatigue, chills, some confusion, and fever (101.4). I left work and went home to bed.
73 2021-04-26 feeling abnormal, disturbance in attention About 8 hours after receiving the shot I had a fever of 103.8, aches, chills, nausea, diarrhea, head... Read more
About 8 hours after receiving the shot I had a fever of 103.8, aches, chills, nausea, diarrhea, headaches, and body aches lasting for 2 days. Since then I have been experiences fevers, chills, aches and pains which come on suddenly and last anywhere from 2 to 10 days. My head gets "fuzzy", I am unable to concentrate, my legs feel "rubbery". I have loss of appetite, taste, and smell, and my toes on both feet get red and swollen, especially on the soles of my feet on the pads beneath my toes. I'm tired all the time and have been known to sleep for days at a time.I haven't felt "normal" since I had the second shot. I had no adverse reactions to the first shot.
73 2021-04-27 feeling abnormal 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 2021-04-28 memory impairment 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 sleep disorder She got her vaccine, was really tired and her arm was hurting. Went to bed, and woke up in the morn... Read more
She got her vaccine, was really tired and her arm was hurting. Went to bed, and woke up in the morning at 4:00 AM with vaginal bleeding one episode. Then it stopped and then she had a reoccurrence on 4/26/21, 4/27/21 and again on 4/28/21 and then it stopped again. Had slight cramping. No problems from the vaccine site itself.
73 2021-04-29 anger, agitation, hallucination, irritability The day before the first vaccine she was up and acting normal, laundry, housework and knew what to d... Read more
The day before the first vaccine she was up and acting normal, laundry, housework and knew what to do. She has severe dementia but was doing OK and knew where she was. She got the first vaccine on 1/29/21, and the 3rd and 4th day they noticed she was having hallucinations and saying things that weren't there. She could hear baby's crying but there were no baby's present. Within 7 days she had what the son described as a stroke. He said that she was watching television and he was on a conference call and he noticed she walked into a wall and he asked if she was okay and starting stumbling across the room and when he touched her she felt very heavy and said that one side of her face was drooping. He got her back into the chair and called 9-1-1. She was so agitated at the hospital that the husband does not know what they gave her and they kept her for a week. They finally got her under control. They discharged her from there and she that was all that they could do with her. They brought her home with nurses assistance and her paranoia was evident, hallucinations were very evident. They said that they tried to do a CAT Scan and an MRI and they said that she did not have a stroke. Restless was very adamant, talking strange things and wanting to go to her son's house when she was there. Before that vaccination she knew where she was and after that she did not know where she was thinking she was at one location and just confusion. She then got her 2nd vaccine and then her husband went out of town and took her back home on 2/24/21 as he was able to get her in a car and travel and able to eat and knew somewhat what was going on. On 2/25/21 when he brought her home to a long term care facility. She was chanting constantly, had irritability, anger, cognition completely eroded. She was very agitated, very combative. Drugs would not calm her down, and tried to get CAT scans or MRI's but were unsuccessful due to her combativeness. She was screaming and yelling 24 hours a day to the top of her lungs and gave her Ativan which had the adverse effects of what they were supposed to do. Had biting, hallucinations, paranoia. She had a couple of falls, they had her in a wheelchair and tried to feed her and she would fall down. They took her to the hospital a few times and she progressively got worse. On 4/19/21 she shut down and quit eating, quit drinking, closed her eyes, and lasted a week like that and then she died on 4/24/21 @ 2:30 AM. None of her doctors could figure out what had happened. They were finally able to get a CAT scan and felt that she may have a stroke. Finally they memory care facility told them to come a take her to the hospital and they had moved their hospice patient's as she was screaming and disruptive and they could not handle her anymore. They thought she was suffering from Lewy body dementia at one point. They were going to have her tested for that and they could not do it on Saturday when she passed for genetics and missed those timelines and could not do it.
73 2021-04-30 feeling abnormal about 4 weeks after my second shot I started to notice unusual things in my body. I was waking up ev... Read more
about 4 weeks after my second shot I started to notice unusual things in my body. I was waking up every day with severe cramps in my calfs. I did not change my exercise routine and never have had that problem before in my life. Then I noticed that both of my knees were very sore- that has never happened to me before. Then yesterday I got alarmed when I found myself getting VERY dizzy every time I bent or stooped and then stood- I almost fell over- that NEVER happened to me before. Today I feel a bit like "brain fog" and that is also a new experience for me. I am hoping I have not had a brain blood clot or other adverse reaction to the shot. These are strange symptoms but so unusual for me that I felt I had to report them.`
73 2021-05-04 excessive sleepiness 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 2021-05-12 feeling abnormal, mental impairment, loss of personal independence in daily activities ?Moderna COVID?19 Vaccine EUA? Sorry, I put my 2 vaccination above.... the second one was on Febr... Read more
?Moderna COVID?19 Vaccine EUA? Sorry, I put my 2 vaccination above.... the second one was on February 11, 2021.... Moderna Vaccination Side Effects Report May 13, 2021 First Vaccination ? February 11, 2021 I did not have any effects the first week. Then on the very same day of the week, in the following week, my arm, where I got the injection, got red and swelled up nearly from my elbow to my shoulder. It was hot and hard and ached. It was sore to the touch. That was on Thursday. On Sunday, I woke up OK, but as I dressed and started moving around, things did not feel right. Soon, I knew that I was not going to be able to do the normal things of the day. Within about an hour of being up from bed, I had a sever attach of vertigo. I thought is was actually Vertigo, which I sometimes have, so I tried the ?exercise? that you can do to remove the debris from the ear canal and relieve the Vertigo?. This has worked for me in the past. But, after trying it three times?. Barely being able to perform the procedure because of the severity of the Vertigo that I was experiencing, my daughter said that it might be from the vaccination. She helped me to my bed. I could not stand or move well. Any time I moved my head or my eyes?even if they were closed? everything would spin more. No matter what I did, I couldn?t the spinning to stop. Finally, after I held my head and eyes very still, I fell asleep and slept for 7 hours straight. When I finally awoke, the dizziness had begun to subside. I slept for 2 more hours and started to feel more normal the next day. The swelling and pain in my arm stayed for another 2 weeks. Second Vaccination ? March 11, 2021 I had the injection in the afternoon and did not notice any real issues that day. On the second day, when I awoke, I did not feel well?kind of dizzy and nauseous?.but not the Vertigo type of dizziness?just an off balance sort of dizziness. Then I noticed that I couldn?t move or think very well. It was like everything was in slow motion. I tried to do the normal things of the day, but finally just gave up and went back to bed. It was like my mind was watching everything go on in slow motion. I slept the whole day again. The next day I was mostly better, but after a couple of weeks, I started having frequent momentary dizzy spells. They did not seem to be triggered by anything. They just came and went. The dizzy spells went on for several weeks? probably a month and gave way to another reaction that is difficult to explain because I have never had this experience before. It is like when I move around or turn my head, my eyes do not go with me! It is not a dizzy spell, although it does cause some dizziness. And, my eyes do not go out of focus. It is more like they are out of ?alignment? with each other or something like that. It is very disconcerting and takes 1 to 3 seconds to come to correction. It is happening more and more frequently. That would be probably about 80% of the time that I move my body or my head. It is now May and it does not seem like the side effects are abating.
73 2021-05-22 feeling abnormal Extreme fatigue, muscle weakness in legs particularly upper legs, all over body joint inflammation, ... Read more
Extreme fatigue, muscle weakness in legs particularly upper legs, all over body joint inflammation, contiual headache and ?brain fog?, and affecting walking up steps and allover general sick feeling.
73 2021-05-24 agitation, anxiety 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 2021-05-25 sleep disorder sleep issues, couldn't sleep
73 2021-05-29 feeling abnormal Day 1: sore arm, headache, fatigue, extreme chills; Day 2: 100 degree fever (even with Excedrin), bo... Read more
Day 1: sore arm, headache, fatigue, extreme chills; Day 2: 100 degree fever (even with Excedrin), body aches, fatigue, heavy arm, brain zaps, sweating, headache, nasal congestion; Day 3: 99 degree fever, unrelenting headache, nasal congestion; Day 4: unrelenting headache, weak, fatigue, nausea, nasal congestion; Day 5: unrelenting headache, weak, fatigue, body pain, including soles of feet, foggy brain; Day 6: unrelenting headache, nasal congestion; Day 7: unrelenting headache, indigestion, nasal congestion, vertigo, itchy rash on injection site, painful soles of feet; Day 8: constant headache, vertigo, especially while lying down, itchy all over; Day 9: constant headache; Day 10: constant headache; Day 11: constant headache
73 2021-05-31 anxiety developed hissing/ringing in ears with some vertigo and dizziness causing headaches, eye aches, gene... Read more
developed hissing/ringing in ears with some vertigo and dizziness causing headaches, eye aches, general fatigue and anxiousness
73 2021-06-03 feeling abnormal On 02/14/2021 the next morning after recieving my 2nd dose, I ran a mild fever and felt bad. I slept... Read more
On 02/14/2021 the next morning after recieving my 2nd dose, I ran a mild fever and felt bad. I slept most of the morning and slept a bit in the afternoon as well. The second morning 02/15/2021 I felt fine, but in the afternoon I felt fatigued so I went to bed. By 02/16/2021 I felt better. I did take Tylenol for the fever. No other medications were taken.
73 2021-06-03 loss of personal independence in daily activities moderna #1 2/6 , 9 days later she developed a large red spot on her arm, 8 inch long, lasted a week ... Read more
moderna #1 2/6 , 9 days later she developed a large red spot on her arm, 8 inch long, lasted a week and since faded, New sx started for about 1 week Neck feels stiff over mid line, not into shoulders, sore to touch on one side, and same into hips, stiff, no pain into arms or thighs, no fevers, no specific joints are swollen, no headache or vision changes, no pain in jaw with chewing or talking She started first with tylenol, switched to voltaren oral and thinks is helping some, getting up in am and up from supine/prone is her worst time she was started on prednisone for possible PMR, she started at 40mg daily but not recovering after 1 week, increased to 60mg with relief and decreased in crp, she continued on 60mg for 2 weeks, then tapered to 40mg , 30 mg and 20mg every 2 weeks, she has now tapered to 10mg daily every 2 weeks by 2.5mg was seen in office today with complete resolution of symptoms
73 2021-06-08 feeling abnormal 3/4 vaccination 3/5 I was extremely tired, lethargic, feeling really wiped out. I didn't do anything... Read more
3/4 vaccination 3/5 I was extremely tired, lethargic, feeling really wiped out. I didn't do anything that day. This occurred on the 6th, 7th, 9th, 10th, 17th, 22nd, etc. with the extreme fatigue. I remember the afternoon of the 22nd, I saw the doctor, every bit of energy was gone. Just not feeling well past that date but I didn't write those dates down I rested and did not see the doctor. *questionable if had COVID in fall 2020
73 2021-06-11 confusional state 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 2021-06-17 memory impairment, amnesia, anxiety, confusional state CONFUSION, MEMORY LOSS, ANXIETY, UNSTABLE GAIT. EXAM SHOWS DECLINE IN SHORT TERM MEMORY AND COGNITI... Read more
CONFUSION, MEMORY LOSS, ANXIETY, UNSTABLE GAIT. EXAM SHOWS DECLINE IN SHORT TERM MEMORY AND COGNITIVE FUNCTION WHICH WAS RAPID FROM PRIOR VISITS WHERE NEUROCOGNITIVE FUNCTION WAS COMPLETLEY NORMAL. GAIT IS SLIGHTLY ATAXIC
73 2021-06-17 sleep disorder pneumonia; ear canal infection; slight ringing in the ear that came and went; arm is red and swollen... Read more
pneumonia; ear canal infection; slight ringing in the ear that came and went; arm is red and swollen and itching like crazy; headache; shoulder pain, it was hurting and burning; Terrible chills; arm is red and swollen and itching like crazy; arm is red and swollen and itching like crazy; pretty bad side effects; piercing ear pain; could not sleep; ear shooting pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. Concomitant products included VITAMINS NOS for an unknown indication. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 21-Mar-2021, the patient experienced ADVERSE REACTION (pretty bad side effects), EAR PAIN (piercing ear pain), SLEEP DISORDER (could not sleep), EAR PAIN (ear shooting pain), VACCINATION SITE PRURITUS (arm is red and swollen and itching like crazy), HEADACHE (headache), ARTHRALGIA (shoulder pain, it was hurting and burning), CHILLS (Terrible chills), VACCINATION SITE ERYTHEMA (arm is red and swollen and itching like crazy) and VACCINATION SITE SWELLING (arm is red and swollen and itching like crazy). On 22-Mar-2021, the patient experienced EAR INFECTION (ear canal infection) and TINNITUS (slight ringing in the ear that came and went). On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, PNEUMONIA (pneumonia), ADVERSE REACTION (pretty bad side effects), EAR PAIN (piercing ear pain), SLEEP DISORDER (could not sleep), EAR PAIN (ear shooting pain), EAR INFECTION (ear canal infection), VACCINATION SITE PRURITUS (arm is red and swollen and itching like crazy), HEADACHE (headache), ARTHRALGIA (shoulder pain, it was hurting and burning), CHILLS (Terrible chills), VACCINATION SITE ERYTHEMA (arm is red and swollen and itching like crazy) and VACCINATION SITE SWELLING (arm is red and swollen and itching like crazy) outcome was unknown and TINNITUS (slight ringing in the ear that came and went) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Other treatments provided by the reporter: heating pad and ear drops. Patient had no side effects from first dose. Action taken with mRNA-1273 in response to the drug was not applicable. Concomitant drug included an unspecified high blood pressure medication. Company Comment: This case concerns a 73 Y/O F with a serious unexpected event of pneumonia, and nonserious unexpected adverse reaction, ear infection, tinnitus, ear pain, sleep disorder, and expected headache, arthralgia, chills, vaccination site erythema, vaccination site swelling, and vaccination site pruritus. Event latency 1 day after 2nd 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.; Sender's Comments: This case concerns a 73 Y/O F with a serious unexpected event of pneumonia, and nonserious unexpected adverse reaction, ear infection, tinnitus, ear pain, sleep disorder, and expected headache, arthralgia, chills, vaccination site erythema, vaccination site swelling, and vaccination site pruritus. Event latency 1 day after 2nd 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.
73 2021-06-20 feeling abnormal I began to feel like my balance was off. It continue through the weekend. I had to keep a hold of th... Read more
I began to feel like my balance was off. It continue through the weekend. I had to keep a hold of things like walls and chairs when I walked. I contact my doctor to see him on April 09, 2021 because of these Virgo symptoms. He gave a steroid injection into my right ear. My Virgo balance was dormant ever since 2018. I had a wiggle and rocking feeling in both feet. Tingles in the back on my legs. So, my doctor referred me to do vestibular therapy which started on April 19, 2021 to June 8th. My therapist did state that she had 5 patients with post Covid-19 vaccine with Virgo balance issues. He also referred me to a neurologist. My appointment is set for July 30th. I did improve.
73 2021-06-21 feeling abnormal 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 2021-06-22 disturbance in attention, loss of personal independence in daily activities, insomnia, feeling abnormal The next day after the vaccine, I started with a headache and it kept getting worse. I started achin... Read more
The next day after the vaccine, I started with a headache and it kept getting worse. I started aching all over and getting a low grade fever and chills and flu like symptoms. The following day, I had extreme fatigue, sweating, weak and tired. I stayed home and in bed for 5 days and could not do normal daily activities. I started getting better however I am still suffering from extreme chronic fatigue every day to some degree. I get brain fog, muscle and joint pain, extremely tired, trouble sleeping, trouble concentrating and unable to complete daily task.
73 2021-06-22 sleep disorder Vertigo, exhaustion, legs and arms numb, sharp stabbing pains in legs, fingers, toes and face, heada... Read more
Vertigo, exhaustion, legs and arms numb, sharp stabbing pains in legs, fingers, toes and face, headaches, unable to sleep, swollen glands
73 2021-06-23 memory impairment Pain at injection site, immediate dizziness, lightheadedness, feeling like head heavy and like someo... Read more
Pain at injection site, immediate dizziness, lightheadedness, feeling like head heavy and like someone slamming it, forgetfulness. Extremities felt heavy, like I'd been drugged. Pharmacy people took turns staying with me in the waiting area for an hour until I could walk out of the store and drive the five-minute drive home. Slept all afternoon. Felt nausea in evening, which persisted the next day along with dizziness and need to sleep. This is second day and feeling better by evening, but not fully recovered from lightheadedness. Called my doctor and reported adverse effects.
73 2021-06-24 loss of personal independence in daily activities Approximately 4 weeks after receiving her second shot, she started noticing shortness of breath. W... Read more
Approximately 4 weeks after receiving her second shot, she started noticing shortness of breath. When I was visiting with her, the week after holiday, I noticed that she was wheezing. She had not had any acute symptoms related to her asthma prior to this instance. Her symptoms have been controlled with Fasenra, Breo and Incruse. She is now experiencing shortness of breath after walking 15 feet. She becomes short of breath when going from her bed to bathroom and when walking from her bed to the kitchen. Majority of her time is now spent in bed due to the difficulty breathing. She has difficulty completing ADL and requires a wheelchair when visiting her doctors. Mom also reports that she "looses her breath" occasionally when sitting in bed. She has seen her pcp, pulmonologist, had an MRI and a stress test. So far,
73 2021-07-02 euphoric mood, feeling abnormal, abnormal dreams, fear, nightmare tardive dyskinesia; Cold; feeling strange/states she it was strange/felt surreal/did not know if she... Read more
tardive dyskinesia; Cold; feeling strange/states she it was strange/felt surreal/did not know if she was dreaming or if this was real/she felt like she was floating; Scratch; She felt like she was in never never land; It scared her; Pins and Needles all over her body/like when the arm or foot falls asleep; Woke up and thought she was still sleep (Dream State)/did not know if she was dreaming or if this was real; felt like inside her body was cold; Nightmares; joint pain; Chills/had the weirdest chills she ever experienced/they were not normal chills; Fever; Nausea; Vomiting; Headache; Muscle pain; This spontaneous case was reported by a patient and describes the occurrence of TARDIVE DYSKINESIA (tardive dyskinesia) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO), METOPROLOL and LEVOTHYROXINE 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 10-Feb-2021 at 11:22 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced TARDIVE DYSKINESIA (tardive dyskinesia) (seriousness criterion medically significant), NASOPHARYNGITIS (Cold), FEELING ABNORMAL (feeling strange/states she it was strange/felt surreal/did not know if she was dreaming or if this was real/she felt like she was floating), SCRATCH (Scratch), EUPHORIC MOOD (She felt like she was in never never land), FEAR (It scared her), FEELING OF BODY TEMPERATURE CHANGE (felt like inside her body was cold), ARTHRALGIA (joint pain), VOMITING (Vomiting) and MYALGIA (Muscle pain). At the time of the report, TARDIVE DYSKINESIA (tardive dyskinesia), NASOPHARYNGITIS (Cold), FEELING ABNORMAL (feeling strange/states she it was strange/felt surreal/did not know if she was dreaming or if this was real/she felt like she was floating), SCRATCH (Scratch), EUPHORIC MOOD (She felt like she was in never never land), FEAR (It scared her), FEELING OF BODY TEMPERATURE CHANGE (felt like inside her body was cold), ARTHRALGIA (joint pain), VOMITING (Vomiting) and MYALGIA (Muscle pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 101.5 (High) 101.5 F. No treatment information 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 22-Jun-2021: Follow up received on 22-JUN-2021 : dose details, events and case seriousness was 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.
73 2021-07-12 confusional state, disorientation 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 2021-07-13 sleep disorder Tinnitus. Constant ringing in the ears and is intensifying. Does not stop and is affecting sleep. ... Read more
Tinnitus. Constant ringing in the ears and is intensifying. Does not stop and is affecting sleep. Have reached out for medical care.
73 2021-07-15 confusional state Pt admitted on 7/15 with CC of confusion and tested positive for CoVid-19 on 7/16/2021.Per guideline... Read more
Pt admitted on 7/15 with CC of confusion and tested positive for CoVid-19 on 7/16/2021.Per guidelines all hospitalizations are reported.
73 2021-07-16 insomnia I experienced severe pain throughout my body after 1.5 weeks of first shot. The pain was unbearable... Read more
I experienced severe pain throughout my body after 1.5 weeks of first shot. The pain was unbearable and I had much difficulty moving and sleeping
73 2021-07-17 mental impairment, memory impairment Side effects are like GBS (Guillain-Barré syndrome); Right side of her body has weakened due to the... Read more
Side effects are like GBS (Guillain-Barré syndrome); Right side of her body has weakened due to the Moderna vaccine; Forgetful; Sometimes is short of breath; Stumbling; Isn't going to received the second dose; Dizziness; Losing her balance; Lost sense of taste (couldn't taste sour)/food doesn't taste good at all now; Lost 20 lbs. from not eating as much; Headache; hard time thinking; Tingling of right arm/ tingling and numbness in right arm/hands started tingling like "pins and needles"/diagnosed with Paresthesia possibly from the Moderna vaccination; "Hands went kind of numb"/numbness spread up both arms/right side of her body was numb; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Side effects are like GBS (Guillain-Barré syndrome)), HEMIPARESIS (Right side of her body has weakened due to the Moderna vaccine) and MENTAL IMPAIRMENT (hard time thinking) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) 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 INSULIN GLARGINE (LANTUS), THYROID (ARMOUR THYROID), COLECALCIFEROL (VITAMIN D3), VITAMIN B12 NOS, ZINC CHELATE from 12-Jul-2021 to an unknown date and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PARAESTHESIA (Tingling of right arm/ tingling and numbness in right arm/hands started tingling like "pins and needles"/diagnosed with Paresthesia possibly from the Moderna vaccination), HYPOAESTHESIA ("Hands went kind of numb"/numbness spread up both arms/right side of her body was numb), NAUSEA (Nausea) and MENTAL IMPAIRMENT (hard time thinking) (seriousness criterion medically significant). On 26-Apr-2021, the patient experienced DIZZINESS (Dizziness), BALANCE DISORDER (Losing her balance), AGEUSIA (Lost sense of taste (couldn't taste sour)/food doesn't taste good at all now), WEIGHT DECREASED (Lost 20 lbs. from not eating as much) and HEADACHE (Headache). On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Side effects are like GBS (Guillain-Barré syndrome)) (seriousness criterion medically significant), HEMIPARESIS (Right side of her body has weakened due to the Moderna vaccine) (seriousness criterion medically significant), MEMORY IMPAIRMENT (Forgetful), DYSPNOEA (Sometimes is short of breath), GAIT DISTURBANCE (Stumbling) and PRODUCT DOSE OMISSION ISSUE (Isn't going to received the second dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GUILLAIN-BARRE SYNDROME (Side effects are like GBS (Guillain-Barré syndrome)), HEMIPARESIS (Right side of her body has weakened due to the Moderna vaccine), HYPOAESTHESIA ("Hands went kind of numb"/numbness spread up both arms/right side of her body was numb), BALANCE DISORDER (Losing her balance), AGEUSIA (Lost sense of taste (couldn't taste sour)/food doesn't taste good at all now), WEIGHT DECREASED (Lost 20 lbs. from not eating as much), MEMORY IMPAIRMENT (Forgetful), DYSPNOEA (Sometimes is short of breath), GAIT DISTURBANCE (Stumbling) and HEADACHE (Headache) outcome was unknown, DIZZINESS (Dizziness), PARAESTHESIA (Tingling of right arm/ tingling and numbness in right arm/hands started tingling like "pins and needles"/diagnosed with Paresthesia possibly from the Moderna vaccination), NAUSEA (Nausea) and MENTAL IMPAIRMENT (hard time thinking) had not resolved and PRODUCT DOSE OMISSION ISSUE (Isn't going to received the second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Magnetic resonance imaging head: stroke was not diagnosed (Inconclusive) stroke was not diagnosed. In 2021, Blood pressure measurement: high (High) Blood pressure increased.. In 2021, Electrocardiogram: normal (normal) Normal; stroke was not diagnosed.. On 18-Jun-2021, SARS-CoV-2 antibody test: negative (Negative) Negative. 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 reported experiencing events similar to GBS (Guillain-Barre syndrome), however, diagnosis had not yet been medically confirmed. Patient laboratory investigation included, on an unknown date, a visit to emergency room (Blood test, urine analysis, EKG and X-rays). Results were 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. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up was received on 13-JUL-2021 Contains significant information. Updated Reporter information, patient demographics and suspect drug information. Added, Laboratory investigation, concomitant and treatment medication and New events information.; 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 2021-07-20 agitation Burning sensation on both of her legs; Statis dermatitis; Agitated; Infection leg; arm soreness; Exc... Read more
Burning sensation on both of her legs; Statis dermatitis; Agitated; Infection leg; arm soreness; Excruciating pain on both legs; Arm soreness at the injection site; Extreme edema in both legs; Triggered Manic episodes; Lupus flare up; Arthritis flare up; Swelling of both legs; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Psoriasis, Cellulitis and Intra-cerebral aneurysm clipping since an unknown date. Concurrent medical conditions included Drug allergy (Allergy to Methothrexate.), Drug allergy (Allergy to Prednisone.), Drug allergy (Allergy to Peroxide (topical).), Hepatitis B carrier and Bipolar disorder. On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) (seriousness criterion medically significant), ARTHRITIS (Arthritis flare up), PERIPHERAL SWELLING (Swelling of both legs), OEDEMA PERIPHERAL (Extreme edema in both legs), MANIA (Triggered Manic episodes), PAIN IN EXTREMITY (Excruciating pain on both legs) and VACCINATION SITE PAIN (Arm soreness at the injection site). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation on both of her legs), STASIS DERMATITIS (Statis dermatitis), AGITATION (Agitated), LOCALISED INFECTION (Infection leg) and PAIN IN EXTREMITY (arm soreness). The patient was treated with AMOXICILLIN at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. On 09-Jul-2021, VACCINATION SITE PAIN (Arm soreness at the injection site) had resolved. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up), ARTHRITIS (Arthritis flare up), PERIPHERAL SWELLING (Swelling of both legs), BURNING SENSATION (Burning sensation on both of her legs), OEDEMA PERIPHERAL (Extreme edema in both legs), AGITATION (Agitated), LOCALISED INFECTION (Infection leg), PAIN IN EXTREMITY (Excruciating pain on both legs) and PAIN IN EXTREMITY (arm soreness) outcome was unknown and MANIA (Triggered Manic episodes) and STASIS DERMATITIS (Statis dermatitis) 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. Based on the current 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.
73 2021-07-20 feeling abnormal Forty five minutes after vaccine brain started feeling like it was speeding, felt buzzy, face start... Read more
Forty five minutes after vaccine brain started feeling like it was speeding, felt buzzy, face started swelling, numbness and tingling in right arm, tiredness, fatigue, unable to stand noise, loss of voice, out of breath when taking long walks
74 2021-01-11 feeling abnormal Pain at injection site first night of shot. Nothing further until 1/10/21 when i woke with rash an... Read more
Pain at injection site first night of shot. Nothing further until 1/10/21 when i woke with rash and heat and itching. Today 1/11/21 rash is larger and I am feeling flu like. Nothing incapacitating but just strange.
74 2021-01-15 restlessness, insomnia, sleep disorder My left arm was sore a couple of hours after the injection. It continued to get worse throughout the... Read more
My left arm was sore a couple of hours after the injection. It continued to get worse throughout the day. That night had a hard time sleeping as it was painful and kept waking me up. I believed it would just get better on its own. It is now 2 days after the vaccine and again another restless night of pain. It is not getting better but seems to be moving down my arm. The injection was at the top of my shoulder, it is uncomfortable about 3 inches down my arm. I broke my shoulder In April of 2019, It feels just like that as I try to move my arm around.
74 2021-01-15 sleep disorder On the same day as injection, there was some redness at injection site, but no itching. 9 days after... Read more
On the same day as injection, there was some redness at injection site, but no itching. 9 days after injection, injection site is redder, painful, and itching enough to where it interfered with sleep.
74 2021-01-19 feeling abnormal Patient reports when she is lying down within 3 days of being vaccinated a feeling of "head floating... Read more
Patient reports when she is lying down within 3 days of being vaccinated a feeling of "head floating" and "feeling dizzy". This subsides as the day goes on and gets better until late night. Patient reports this has been ongoing since the 3 day. She will follow-up with PCP for further testing and evaluation.
74 2021-01-19 loss of personal independence in daily activities 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 2021-01-21 anxiety 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 2021-01-24 feeling abnormal Pt stated she felt really bad all day after vaccination. Pt stated the next day she had severe itch... Read more
Pt stated she felt really bad all day after vaccination. Pt stated the next day she had severe itching on back that moved to the front torso and shoulders. Pt said she has been taking Benadryl for the itching . Stated she called her PCP and they advised her to take Benadryl and to come to the office tomorrow for an appt.
74 2021-01-24 insomnia Patient received vaccination at 1115, by bedtime patient has sore arm, during the night her temp was... Read more
Patient received vaccination at 1115, by bedtime patient has sore arm, during the night her temp was 1.5 degrees higher than normal for her, achy difficulty sleeping.,
74 2021-01-25 insomnia By the late afternoon/early evening I had developed a rash that covered my body from the bottom of ... Read more
By the late afternoon/early evening I had developed a rash that covered my body from the bottom of my feet to the top of my head. The rash was clearly visible but not bumpy. It was extremely itchy. I took Benadryl and soaked in an Epsom Salt bath several times that night as I was unable to sleep due to the intense itching. The next morning (Saturday) I called my doctor and was prescribed a steroid to combat the itching but was told not to take it until Monday so as not to interfer with the antibodies my body was obviously producing in response to the vaccine. I was also instructed to start taking one Zyrtec tablet each morning and two Benadryl tablets each night. On Monday morning (01/25/2021) I began taking Methylprednisolone (4mg Dospak 21s) which relieved the itching. At this time the rash is greatly reduced and the itching has almost stopped. I will continue the meds until the dosage is completed.
74 2021-01-25 sleep disorder 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 2021-01-26 anxiety, feeling abnormal Vaccine received Sunday at 3:30 p.m. Monday: Muscle pain, some shortness of breath, lethargy, redn... Read more
Vaccine received Sunday at 3:30 p.m. Monday: Muscle pain, some shortness of breath, lethargy, redness in face and some mild swelling of face, loss of appetite. Tuesday, some improvement, but lethargy, loss of appetite, and anxiety and general bad feeling continued. Went to Urgent Care Tueday pm, about 48 hours after admin of vaccine. Advised to take benadryl at bedtime, Zyrtec in the morning, Wednesday morning still lethargic, some muscle pain, anxiety.
74 2021-01-28 feeling abnormal Felt 'rush' throughout the body after 15 minutes of injection. Drank lots of water. Chills 50 minute... Read more
Felt 'rush' throughout the body after 15 minutes of injection. Drank lots of water. Chills 50 minutes after injection. Took Tylenol. Day 8, arm itchy and red around the injection site. Warm to the touch. Day 9, more redness and larger area. Size of a silver dollar. Talked to the nurse at a local gym. Suggested a clinic. I Saw a Nurse Practioner at a clinic. She thought perhaps it was an insect bite as the red area was about 4 inches below where a 'normal shot' would be given. Prescribed cream and antibiotic. I didn't take it. Took Benadryl (pill). Improving after 1 hr of taking Benadryl.
74 2021-01-31 feeling abnormal 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 nervousness 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 excessive sleepiness 2/1/2021 - low fever, headaches dry throat (needing almost constant iced drinks), dizzy, weak, sleep... Read more
2/1/2021 - low fever, headaches dry throat (needing almost constant iced drinks), dizzy, weak, sleeping a lot, eyes hurt, can't eat, dry cough, arm sore. 2/2/2021 - same as above but lessened. large (3x5) hot, red swollen sore arm
74 2021-02-04 loss of personal independence in daily activities When woke up the next morning, felt feverish took temperature and it was 100.7F, felt extreme fatigu... Read more
When woke up the next morning, felt feverish took temperature and it was 100.7F, felt extreme fatigue could not get out of bed, legs were very weak, could not move out of bed. Called ER and they told me to take some aspirin (2). I tried to walk around the house and eat but decided to go back to bed and slept it off. ER also told me to drink electrolytes, I could not even open the bottle, I had to call my daughter to come and open it for me. I broke up in a sweat last night around midnight, this morning I took my temp it was 98F and I still feel weak. I also woke up with a headache and my nose is stuffed up, I have some mucus. Feels like a head cold.
74 2021-02-06 loss of personal independence in daily activities I was fine until about 10:00 pm that night. Started with chills and body aches. Then my arm where ... Read more
I was fine until about 10:00 pm that night. Started with chills and body aches. Then my arm where the injection was, became extremely sore. I was in bed all day the following Saturday and Sunday. I had covid and it was almost as bad as the virus .
74 2021-02-06 sleep disorder Just a bit of pain 1st night . Then 12 days after-vaccine developed red, hot, itchy , raised area ... Read more
Just a bit of pain 1st night . Then 12 days after-vaccine developed red, hot, itchy , raised area hard patch .. a pimple downed at the injection point.. very itch.. No other symptoms .. Called online nurse .. told to ice , Benadryl and gulp all as needed days 13- 17 the symptoms continue . I have read it is referred to as ? Covid Arm? And mine looks and sounds similar ..I have left shoulder pain at night .. enough to wake me to take a Tylenol. I do Participate in all my daily activities .. I plan Call Kaiser and my Dr on Monday 8 Feb as I am Reluctant to Take dose 2 on 20 February
74 2021-02-07 anxiety C/O feeling Anxious and having a fast heart rate Vital signs were monitored and were WNL She wante... Read more
C/O feeling Anxious and having a fast heart rate Vital signs were monitored and were WNL She wanted to return home, was seen by MD @ site and was sent home
74 2021-02-07 sensation of foreign body patient came to counter complaining of feeling in throat. Clinic doctor checked blood pressure and d... Read more
patient came to counter complaining of feeling in throat. Clinic doctor checked blood pressure and did not find any sign of allergic reaction.
74 2021-02-09 disorientation Notified by patient's daughter that she experienced nausea, vomiting, disorientation the afternoon f... Read more
Notified by patient's daughter that she experienced nausea, vomiting, disorientation the afternoon following the shot.
74 2021-02-10 anxiety, nervousness 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 anxiety 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 2021-02-11 anxiety 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 personal independence in daily activities After the Vaccine- Started feeling under the weather in the evening of day 4, with sore lymph nodes ... Read more
After the Vaccine- Started feeling under the weather in the evening of day 4, with sore lymph nodes in neck,. On day 5 ~ Fatigue and exhaustion, unable to do daily tasks and a rash/ hives lasting a few hours. Day 6-9 still feeling fatigued, mainly evenings, but feeling better and able to exercise and do daily tasks.
74 2021-02-12 feeling abnormal Chills began 10 hours after vaccine and lasted from 11:00 pm-9:00 am. Brain Fog most of next day af... Read more
Chills began 10 hours after vaccine and lasted from 11:00 pm-9:00 am. Brain Fog most of next day after vaccine. Terrible headache and nausea began 24 hours after vaccine and lasted approximately 6 hours. 3 Tylenol helped. Inflammation at injection site lasting 2 days.
74 2021-02-12 feeling abnormal chills, fever, upset stomach, rash on face, fuzzy head
74 2021-02-13 excessive sleepiness I woke up at about 4:30 am shivering. Got an additional blanket and tried to warm myself. snuggled... Read more
I woke up at about 4:30 am shivering. Got an additional blanket and tried to warm myself. snuggled into husbands back to get very nauseated and vomited several times. Slept most of the day with little appetite. Had difficulty maintaining body temp but never ran a temperature. Lots of body aches.
74 2021-02-14 anxiety Subjective Patient is a 74 y.o. female who was seen at Vaccine Clinic today for her first dose of t... Read more
Subjective Patient is a 74 y.o. female who was seen at Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience throat tightness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. Pt with hx of htn/a-fib, allergies and asthma. She has taken her allergy medications today along with her htn med. She reports she usually checks her home bp and runs around 140s systolic. She states her bp is up today as she is anxious. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, dizziness and headaches Negative for drooling: No vision changes: Previous Reactions: denies prior reactions. Objective Vitals Vitals: 02/09/21 1153 02/09/21 1156 02/09/21 1159 02/09/21 1200 BP: (!) 154/138 (!) 219/73 (!) 203/71 BP Location: Right arm Left arm Pulse: 74 73 72 70 SpO2: 100% 99% 98% 98% Physical Exam Vitals signs and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. No murmur. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Chest: Chest wall: No tenderness. Musculoskeletal: Right lower leg: No edema. Left lower leg: No edema. Skin: General: Skin is warm. Coloration: Skin is not pale. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines Follow up response to treatment: fair. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) HTN: pt reports she will monitor at home. She states that she gets like this prior to doctor appointments or visits. She feels well and wishes to go home. Discussed reasons to follow up with pcp, monitor bp at home. Follow up in ED if throat symptoms worsens or do not improve. Pt offered wc out to front door. Pt with husband.
74 2021-02-14 feeling abnormal, confusional state, excessive sleepiness light headed, foggy mind, unable to walk, lift hands and arms, did not know where i was. husband put... Read more
light headed, foggy mind, unable to walk, lift hands and arms, did not know where i was. husband put me in high back chair, gurgling in throat or sinuses, eyes closed, could not understand him. temp just before 103. such shallow breathing he thought i might have died,. finally after prodding he saw i was breathing again. He kept putting cold rags on my head and the temp came down to 99. . kind of alert. ate a little. napped for 3 hrs, ate a little, slept 3 more hours and then slept all night. Next day was alright to drive and do about regular lifel. I have the medrna rash on my left arm. getting lighter. got up to 8 inches wide. still not 100% but can function, just need naps.
74 2021-02-16 feeling abnormal 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 insomnia 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 2021-02-17 feeling abnormal, disturbance in attention DIDN'T FEEL LIKE MYSELF, EXTREMELY TIRED, HEADACHE, COULD NOT CONCENTRATE
74 2021-02-17 sleep disorder On 2/10 about 2 hours after the shot, my arm was too sore to move and I was extremely thirsty. I ha... Read more
On 2/10 about 2 hours after the shot, my arm was too sore to move and I was extremely thirsty. I had trouble sleeping because of the pain in my arm. On 2/11 I was exhausted, still thirsty, had muscle aches (especially in my calves) and dull headache.. On 2/12 I felt better in the AM. but by afternoon all symptoms returned, lower back ached, I was queasy. On 2/13 I felt better but was very tired. After that I felt more like myself for the next 5 days. Today, 2/18 at 3PM I developed a rash at the injection site. It was very itchy. I used calamine lotion to calm the rash, which helped.
74 2021-02-19 feeling abnormal 2/17/21 9:00 pm - Mild sore arm 2/18/21 2:35 am - Very sore arm, no fever, fatigue, feel badly. Took... Read more
2/17/21 9:00 pm - Mild sore arm 2/18/21 2:35 am - Very sore arm, no fever, fatigue, feel badly. Took 2 Tylenol 2/18/21 5:10 am - Very sore arm, 99.7 fever, fatigue, feel badly 2/18/21 6:40 am - Very sore arm, 100.8 fever, fatigue, feel badly 2/18/21 8:35 am - Very sore arm, 99.1 fever, fatigue, feel badly, bedridden. Took 2 Tylenol 2/18/21 12:30 pm - Sore arm, 100.2 fever, fatigue, feel badly, bedridden. 2/18/21 4:15 pm - Sore arm, 101.2 fever, fatigue, feel badly, bedridden. Took 2 Tylenol. 2/18/21 10:20 pm - Sore arm, 99.6 fever, fatigue, feel badly, bedridden. Took 2 Tylenol. 2/19/21 7:40 am - Sore arm, no fever, some fatigue 2/19/21 2:15 pm - Sore arm, 100.2 fever (again!), fatigue, back to bed. Took 2 Tylenol. 2/20/21 8:00 am - Sore arm. Found 3" diameter red spot on my right arm just below injection site. First noticed today. No fever, no fatigue.
74 2021-02-20 excessive sleepiness Much pain in both arms and back. Excessive sleep. Had fever night of 2/20/21. By noon of 2/21 f... Read more
Much pain in both arms and back. Excessive sleep. Had fever night of 2/20/21. By noon of 2/21 fever had broke. Temp. 99.5. Still a bit sluggish.
74 2021-02-21 excessive sleepiness day of vaccine lost appetite by dinnertime day after vaccination-temperature 100 degrees, dizzy, wea... Read more
day of vaccine lost appetite by dinnertime day after vaccination-temperature 100 degrees, dizzy, weak, felt like I had the flu. Slept most of the day. next day lethargic, no energy, some headache next day dizzy and nauseous
74 2021-02-21 excessive sleepiness 02/12/2021- 9 PM -Left arm felt great pain at injection site, Midnight- great pain again, chills, ... Read more
02/12/2021- 9 PM -Left arm felt great pain at injection site, Midnight- great pain again, chills, fever, no balance-dizziness, walking into walls, dresser. 02/13/2021-Exhausted, sleeping all day, cold-wrapped in blankets, headaches 02/14/2021- finally sitting up, starting to move around 02/15/2021- starting to recover to normalcy
74 2021-02-22 confusional state, mental status changes Patient had Moderna vaccination on 1/28/2021 and felt well that day and previous days. She woke up t... Read more
Patient had Moderna vaccination on 1/28/2021 and felt well that day and previous days. She woke up the next morning with altered mental status. low grade fever and confusion that improved within a few hours but did not resolve for at least 24 hours. She went to the Emergency Room at Hospital on 1/28/2021 and had labs, urine and CT of head that were all normal/no acute abnormality. Her symptoms resolved at about 24 hours or so and she has been well since. She was released from ER, not admitted.
74 2021-02-22 feeling abnormal Light headed, not functioning in a normal manner, moving slow/ balance, mildly dizzy, and lack the f... Read more
Light headed, not functioning in a normal manner, moving slow/ balance, mildly dizzy, and lack the feeling without well being and conscious control
74 2021-02-22 feeling abnormal Felt ugh, fuzzy headed next day, got chills and had mild fever (99.2), took 2 Tylenol, sucked in cou... Read more
Felt ugh, fuzzy headed next day, got chills and had mild fever (99.2), took 2 Tylenol, sucked in couple ColdEeze and felt better within few hours. Red area on sot arm by that evening - next day (2nd day after shot) developed red rashes by outside of each breast, larger spot by left side (where shot was given), spot on left side of my neck also. Not a raised or bumpy rash at all, not sore or itchy. Called advise nurse to determine taking a benedryl was ok and took one last night. This morning rash less noticeable but still there - also new little mark on inner left elbow. Feeling fine this whole time, just concerned because I haven?t read of this reaction much for second Moderna.
74 2021-02-22 insomnia 5 hrs after injection started getting a headache,10 hrs after started getting constant aching inject... Read more
5 hrs after injection started getting a headache,10 hrs after started getting constant aching injection site arm, from elbow to shoulder, swelling, no redness, no heat. Low grade temp. Took 2 Tylenol 650 mgs. Unable to sleep even with elevated arm and ice.. Continued through the next day but headache gone.Arm pain constant if left down.Next day swelling reduced, but still constant ache, muscle, bone and joints. Today improved, still aching, but tolerable.
74 2021-02-23 feeling abnormal, insomnia Weak, tired, cold, nausea, off balance, migraine headache, eye pain, blurry vision, foggy brain, fac... Read more
Weak, tired, cold, nausea, off balance, migraine headache, eye pain, blurry vision, foggy brain, face pain, trigeminal neuralgia, neck and face hot and red, sweating and shaking, threw up like acid, insomnia, frequent urination, diarrhea.
74 2021-02-23 feeling abnormal At 1050 Patient reported that she was feeling "weird" states that she felt like her chest and arms w... Read more
At 1050 Patient reported that she was feeling "weird" states that she felt like her chest and arms were tingling. We sat her down and asked her if she had ever felt this way before and she stated that once she had a medication that made her break out in a rash that started out with tingling but eventually got worst. Nurse at this time recommended to patient that she should stay for 30 mins for further observation, patient refused. When questioned patient denied itchiness, shortness of breath, or any other symptoms except for tingling. Nurse offered benadryl prior to her leaving and she agreed, dose administered at 1058. At 1100 patient left the premises. At 1445 Nurse called patient with CDC recommendation that she does not receive her second dose of Moderna per her reaction. Patient stated that she wants to continue with receiving her second dose because as soon as she "took off her tight brawl" the symptoms went away. Patient does not believe symptoms were related to vaccine. Patient denied having any further symptoms; rash, shortness of breath, or further tingling at this time.
74 2021-02-23 insomnia About 10 minutes after receiving the Maderna vaccine my head started hurting which I reported to the... Read more
About 10 minutes after receiving the Maderna vaccine my head started hurting which I reported to the doctor on site. She talked to me and said I was ok to go. My headache pain persisted all day and into the next. For the pain I took Tylenol and Advil. The pain has not let-up since the day of my vaccination. In addition to the head pain, I started sneezing and had terrible eye irritation with burning and watering. These side effects are still persisting. The worst, however, is the severe head pain which only settles down when I sleep. I am sleeping only 3-4 hours at night now. I wake up for a bathroom break at 3-4 A M and can't go back to sleep. My head pain starts after I get up every morning about 1/2 hour to an hour. My doctor recommended taking Extra Strength Tylenol and Advil alternating them and an antihistamine. Functioning day to day and making decisions has been very difficult. But, the pain is the worst!!!
74 2021-02-24 abnormal behaviour, confusional state, feeling abnormal She got home and after 3 hours she started seeing things, and talking nonsense. Every bone in her bo... Read more
She got home and after 3 hours she started seeing things, and talking nonsense. Every bone in her body was hurting. It was early in the morning and she thought it was in the middle of the night. Her husband had to help her to walk with the walker, and was out of her head. She has not been able to walk since Monday afternoon about 4:00. She is now just today able to get to the bathroom. She has taken Extra Strength Tylenol, Trazedone and Klonopin so she could sleep as she has not been able to. She has never experienced anything like this in her life due to the pain. She is a little better today, she gets dizzy when she gets up but still in the bed. She called the doctor yesterday and spoke to the nurse who told her to go to the ER but did not as her husband cannot help her much as he has prostate cancer.
74 2021-02-25 disturbance in attention, feeling abnormal, impaired work ability 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 feeling abnormal 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 2021-02-25 sleep disorder one week after first dose of vaccine developed intense itching right arm with purpura and swelling ... Read more
one week after first dose of vaccine developed intense itching right arm with purpura and swelling resulting from itching , itching continued to spread to all over body arms back legs torso neck. intensity would wake me up at night. ice pack only relief. have consulted 3 dermatologists, one internal medicine, and one neurologist. 9 weeks of itching .
74 2021-02-27 feeling abnormal Headache, dizziness, diarrhea, nausea, vomiting, brain fog, tremors, weakness, exhaustion
74 2021-02-28 anxiety Pt received vaccine at 1030. At 1055 reported feeling hot, anxious and a little dizzy. Patient remov... Read more
Pt received vaccine at 1030. At 1055 reported feeling hot, anxious and a little dizzy. Patient removed mask to reveal swelling of lips and face. First responder called and Epi pen administered.
74 2021-03-03 feeling abnormal 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 2021-03-03 impaired work ability It stared out with just stiffness in my legs and back. Then at night I couldn't put my legs down the... Read more
It stared out with just stiffness in my legs and back. Then at night I couldn't put my legs down they hurt and my shins felt like I had shin splines. This lasted about a week or more. I went to a Dr. because my left knee and shin were hurting so bad. The Dr. was not sure and did a Doppler to see If I had a Blood clot in my left knee but I didn't. She put me on an antibiotic, that I really didn't need I don't think. I took that for a few days and stopped because it wasn't helping any. On the 14th I went to see another Dr. and he put me on Prednisone, at this time I could barley walk my right hip was hurting so much. I was taking little bitty steps. The prednisone has been helping, it's allowed me to walk and to function. I was to the point it was getting so bad. I'm still having some stiffness, my left elbow gets inflamed at times, my left hand and knuckle swell and get stiff at times too. It seems to move around at effect different places. The medication helps me move better, I have been off work for 7 weeks, I plan to go back and try half days.
74 2021-03-04 mental status changes altered mental status, acute on chronic thrombocytopenia, death
74 2021-03-05 confusional state Vomiting, body aches, weakness, confusion, headache urinating frequently, fever 101.1 entire day fo... Read more
Vomiting, body aches, weakness, confusion, headache urinating frequently, fever 101.1 entire day following vaccine. Took Tylenol alternating with ibuprofens
74 2021-03-05 sleep disorder 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 excessive sleepiness Started with headache that caused nausea. Then chills and fever: temperature ranging from 96.1 to 1... Read more
Started with headache that caused nausea. Then chills and fever: temperature ranging from 96.1 to 100.5. Slept for almost 36 hrs. Then headache left and I got nausea with minor vomiting and diarrhea. Took almost 4 days to feel much better.
74 2021-03-08 sleep disorder, feeling abnormal 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 2021-03-09 excessive sleepiness, feeling abnormal Started 6 hrs. after shot. Severe bone and joint pain, nausea, very low energy,100 temp or higher. ... Read more
Started 6 hrs. after shot. Severe bone and joint pain, nausea, very low energy,100 temp or higher. arm pain, headache, mind fog, slept for two days, weak could barely walk, no appetite. Mid day third day pain easing, still not hungry, mind fog, temp. down.
74 2021-03-09 sleep disorder My arm was sore. I had a rash around the injection site. I had a fever of 101.5 degrees (my temper... Read more
My arm was sore. I had a rash around the injection site. I had a fever of 101.5 degrees (my temperature usually is 97.7). I had severe gastrointestinal distress and diarrhea all night. I also fought off the urge to vomit all night. I could eat only toast and drink tea the next day. I lost two pounds in one day.
74 2021-03-09 sleep disorder Vaccine was given on left arm. Approximately five hours later, my left arm starting to hurt. It hu... Read more
Vaccine was given on left arm. Approximately five hours later, my left arm starting to hurt. It hurt so badly, I could not lift my arm. The pain was a level 10 (ten being the worse). This is day five and I am still experiencing pain. Friday thru Tuesday was the worst, I could not sleep, the pain kept waking me up.
74 2021-03-10 anxiety, insomnia, feeling abnormal About 4 hours after the vaccine I was so tired i went to bed. After midnight i had fever which ove... Read more
About 4 hours after the vaccine I was so tired i went to bed. After midnight i had fever which over the next two days rose to 101.4. My usual temperature is 97.7. I had severe neck ache and head ache extreme fatigue, and was bed ridden for 4 days. My fever started to decrease on the third day. I had roving pains which lasted 3-4 hours in each place: first the right back above the waist where the kidneys are, then just below my right breast, then the left side of the top of my head. Throughout I had to have a wet cloth on my head. About a week later I had a relapse.... my temperature rose to 98 and I had the same headache place and neck ache at the bottom back of my head along with extreme fatigue and brain fog. It lasted at least two days. Of course as expected my arm was sore, but very swollen like a goose egg, red, and impossible to move. I still feel the same fatigue, and have to go to be very early but have insomnia and extreme anxiety.
74 2021-03-10 confusional state, abnormal behaviour About Feb 18 she started display sudden signs of delusion, confusion, major Cognitive issues, unable... Read more
About Feb 18 she started display sudden signs of delusion, confusion, major Cognitive issues, unable to find words for speach and erratic behavior.
74 2021-03-10 nervousness I got the shot at 11:45am and at 11:50-12:20 they had me sit in a chair and wait to see if I have an... Read more
I got the shot at 11:45am and at 11:50-12:20 they had me sit in a chair and wait to see if I have an allergic reaction because of my allergy history. I sat for 30 minutes. At 12:20 the nurse said my face looked red. she took me to another area to take my blood pressure and said my face looked red and blotchy. at 12:25 2 more nurses came back and asked me how I was feeling and I told them my throat was getting scratchy and tight and felt like it was closing off. the inside of my mouth started feeling tingly/prickly and my tongue felt thick. My throat started closing off more and my lips started getting tingly and prickly. I started losing my voice as my throat was getting really constricted and I was getting shaky. At 12:30 a nurse gave me a half dose of epinephrine and called for an ambulance. At 12:40 the ambulance took me to the ER in the city. Then at 12:50 I arrived at the ER and they took me back and hooked me up to BP and O2 monitors and did blood tests. I was there until 3:30 pm that day. My BP was going up and down the whole time and I was very shaky. ER Doctor told me to NOT take the second vaccine dose and prescribed me an EpiPen.
74 2021-03-10 sleep disorder Fever (100.7), headache, chills, sweating, Muscle pain, Sever joint pain all over body. Left me una... Read more
Fever (100.7), headache, chills, sweating, Muscle pain, Sever joint pain all over body. Left me unable to sleep for 2 nights because of pain and chills. Sever Pain and redness and swelling around injection site, nausea, fatigue, lymph mode pain and swelling in neck area of left side where injection was given. Generally felt very ill as if I had seasonal flu.
74 2021-03-11 anxiety 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 excessive sleepiness Patient states the day after her first dose she was very tired, so tired that she mostly slept for a... Read more
Patient states the day after her first dose she was very tired, so tired that she mostly slept for a week. She states she went to the ER and they said she was dehydrated and did not think this was related to the vaccine. She states that the past week she has felt better and is back to her baseline starting 3/11/2021
74 2021-03-12 excessive sleepiness Headache beginning 45 mins after second shot, lasting 5 days. Severe headache within 4 hours. No tre... Read more
Headache beginning 45 mins after second shot, lasting 5 days. Severe headache within 4 hours. No treatment. Severe nausea and vomiting beginning 10 pm night of shot or 10 hrs. later, lasting about 12 hours. Extreme chills beginning 10 pm or 910 hrs. after shot. Couldn't hold food down 48 hours. Extreme fatigue beginning 10 pm or 10 hrs after shot, lasting 38 hrs. Slept 14 hours straight after first 24 hours. Symptoms began to subside (except headache) 48 hours after second shot. Headache lasted 120 hours. Began to eat light solids 48 hrs later, began to eat normally 5th day or 120 hrs later. I did not use any treatment or call a Doctor.
74 2021-03-13 feeling abnormal within one hour, little light headed. Within l hour 45 minutes headaches off and on on right side f... Read more
within one hour, little light headed. Within l hour 45 minutes headaches off and on on right side front and behind right ear. The roof of mouth had a strong burning sensation then the top lip and area above top lip went numb and tingling. Arm pain which improved with massaging and swinging arm. Within 3 hours of the vacination, most of numbness and tingling gone from upper lip and above upper lip. From time of vacination, I drank at least one glass of water an hour and swung and massaged arm as needed. Within five hours, almost all adverse symptoms were gone..I was left with a slight headache across forehead and back of head. Slept well that night; no fevers. Morning after shot, slight headache but fine. But by 8:30 a.m. I was very, very tired. Arms and legs felt almost too heavy to move or lift, and I felt a little 'out of it'. Slept 1 1/2 hours. No energy, sat around entire day, drinking about 6 glasses of water. No energy and tired rest of day. Next morning all symptoms except slight headache were gone so I worked in the yard for about an hour. My temperature was normal during the entire experience.
74 2021-03-13 mental status changes Lethargic, SOB, emesis, Altered mental status, respiratory failure Starting day after 2nd vaccine d... Read more
Lethargic, SOB, emesis, Altered mental status, respiratory failure Starting day after 2nd vaccine dose of Thursday afternoon
74 2021-03-14 anxiety 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 2021-03-15 memory impairment, amnesia Marked increase in incidents of short term memory loss with inability to retrieve lost information f... Read more
Marked increase in incidents of short term memory loss with inability to retrieve lost information for approxxmately 6 days
74 2021-03-15 sleep disorder During night awoke to have 2 bouts of watery diarrhea. None during the day. During the day after the... Read more
During night awoke to have 2 bouts of watery diarrhea. None during the day. During the day after the vaccine, experienced tiredness, muscle pains in both arms, mild headache, sharp pain above left eye (only if closed) , felt overheated for a short time, then chilled. Did not take my temperature.
74 2021-03-16 sleep disorder Started to hurt just like any other shot. Never subsided. That night and continuing, I could not sle... Read more
Started to hurt just like any other shot. Never subsided. That night and continuing, I could not sleep on that side. My daughter, who got a shot at the same time, called me on 3/12/2021 to see if I had a rash like she did, so I went and looked in mirror. Rash from shoulder to almost elbow. I called today and sent photo.
74 2021-03-17 confusional state, hallucination This was her 2nd vaccine. I took her to grocery store that day and she seemed fine. The vaccine se... Read more
This was her 2nd vaccine. I took her to grocery store that day and she seemed fine. The vaccine seems to have triggered escalated symptons of dimensia - halluciantion, confusion, suspicison of friends, neighbors, family. was found wandering outside of her apartment building at night and taken to hospital. We had seen the patient 2 days before and my husband had talked with her on 3/12 She was a bit confused but not too bad. certainly no suspcision of family at that time. Concern that vacinne may have triggered the event/
74 2021-03-17 feeling abnormal 27 hours after vaccination, a copious, non-stop rhinitis began. I used up an enormous amount of Klee... Read more
27 hours after vaccination, a copious, non-stop rhinitis began. I used up an enormous amount of Kleenex, was miserable, and my nose became very sore. The nasal fluid was clear. I had no nasal congestion, no sore throat, no sneezing, no cough, no fever (98.4F all day). I tried 25 mg of diphenhydramine after about an hour of this?zero effect. By 11:30 p.m. I was desperate, and l found a cold & flu nighttime product in my cabinet: each tablet contains 325 mg acetaminophen, 10 mg dextromethorphan HBr, 6.25 mg doxylamine succinate, and 5 mg phenylamine HCl. I took 2 tablets and slept 8 hr uninterrupted. The rhinitis was gone when I woke up.
74 2021-03-18 sleep disorder broken blood vessel in the right eye; not getting sleep; Achy; A spontaneous report ) was received f... Read more
broken blood vessel in the right eye; not getting sleep; Achy; A spontaneous report ) was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was achy, not getting sleep and broken blood vessel in her right eye. The patient's medical history was not provided. No relevant concomitant medications were reported. On 02 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 036A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 2 Mar 2021, the patient was achy and was not getting sleep. On 05 Mar 2021, she had a broken blood vessel in her right eye. She stated that she was better but her right eye was still red. No treatment information was provided. Action taken with mRNA-1273 in response to the events achy, not getting sleep and broken blood vessel in her right eye was unknown. The seriousness criterion for the event broken blood vessel in her right eye was medically significant. The outcome of the event, broken blood vessel in the right eye was not resolved, while the outcome of the events not getting sleep and achy was resolving.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
74 2021-03-19 sleep disorder Achy, couldn?t sleep, upset stomach, pain in sternum, for about 36hours; cough for a week
74 2021-03-20 feeling abnormal moderna covid-19 vaccine EUA. About 45 minutes after shot I got a slight headache. Early evening I g... Read more
moderna covid-19 vaccine EUA. About 45 minutes after shot I got a slight headache. Early evening I got chills, worse headache and muscle aches. Saturday had a killer headache, severe muscle aches, extreme fatigue, dizzy and brain fog. The next day I had all of the same but less. Ate dinner night of the vaccine but did not eat or drink anything besides water again until 2 days later at 2pm as I had no appetite. When I ate my stomach hurt a little. I was tired for about 4 days and little appetite.
74 2021-03-22 loss of personal independence in daily activities I started with a dull ache in my right upper arm about a week after the injection. I did not think ... Read more
I started with a dull ache in my right upper arm about a week after the injection. I did not think there was any correlation between the shot and the arm pain. It was not in the joints. It traveled to the lower arm. I could not lift heavy things. The pain is not constant, but it continues at night when I am relaxed to a throbbing type pain. After 2 weeks it went to my left upper arm and then has just been in the elbow joint of the left arm. It only aches when I move it around a lot or lift. The pain has continued until today with no improvements in either arm. I am not in excruciating pain, but I have a hard time lifting objects with my right arm, and turning it a certain angle is more painful at times. I did not strain my arm in any way that I can remember around the time I first experienced pain.
74 2021-03-23 feeling abnormal Began to feel funny 3 1/2 hours later. By 5 hours later I had terrible chills and was in bed. I was ... Read more
Began to feel funny 3 1/2 hours later. By 5 hours later I had terrible chills and was in bed. I was bedridden until 45 hours after the shot. Besides the chills and fatigue, I had a headache and backache.
74 2021-03-23 sleep disorder 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 confusional state, feeling abnormal 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 2021-03-25 altered state of consciousness Stunned; Very high fever; Not able to walk; Not able to speak; A spontaneous report was received fro... Read more
Stunned; Very high fever; Not able to walk; Not able to speak; A spontaneous report was received from a consumer concerning a 74 year old, female patient who experienced very high fever-104.2°F (pyrexia), was stunned (altered state of consciousness), not able to walk (gait inability), and not able to speak (speech disorder). The patient's medical history was not provided. No relevant concomitant medications were reported. On 10 Mar 2021 at 19:00, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot: 029A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 11-Mar-2021, the patient woke up with a very high fever of 104.2°F, stunned, not able to speak or move. The patient took Ibuprofen 600 mg to treat the fever and felt better, but was told that might have been counterproductive. Treatment details included Ibuprofen 600 mg. Action taken with mRNA-1273 in response to the events was not reported. The events of very high fever-104.2°F (pyrexia), was stunned (altered state of consciousness), not able to walk (gait inability), and not able to speak (speech disorder) were considered 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 events, a causal relationship cannot be excluded.
74 2021-03-25 confusional state Confusion, fevers and chills for 72 hours. After 6 weeks. Extreme fatigue , both soles of feet itch... Read more
Confusion, fevers and chills for 72 hours. After 6 weeks. Extreme fatigue , both soles of feet itching for 4-5 days , goes away , has come back. Usually in th evenings and and early mornings. Appetite low, have lost several pounds.
74 2021-03-25 sleep disorder woke up with extreme joint pain persists: difficult to move, sit, sleep fatigue
74 2021-03-27 insomnia Sever pain starting an hour or so after shot getting increasing worse hour by hour , that night... Read more
Sever pain starting an hour or so after shot getting increasing worse hour by hour , that night I was not able to sleep at all. The pain level on a scale of 1-10 on the pain scale was 10+ . It was so bad that at times I was afraid I might lose conciousness. It was excrutiating. X-ray showed possible impingment of my rotator cuff. Expecting to get MRI 4/7/41. as of today I am in constant pain. It increases some and decreases some during the day but at night, I am unable to sleep. If I sleep in a chair sitting up I get a little sleep.
74 2021-03-28 insomnia Intense fatigue combined with strong muscle aches throughout, leading to sleeplessness combined with... Read more
Intense fatigue combined with strong muscle aches throughout, leading to sleeplessness combined with severe lethargy. Did not seem to have a fever, though didn't check it. Some site-injection pain, though not nearly as severe as with the first dose (2/26/21, COVID19 (Moderna) 001 A21 A). The symptoms had abated by late afternoon on Saturday, 3/27/21. Acetominophen helped.
74 2021-03-28 insomnia Sudden onset of high fever (103.5), extreme weakness, fatigue, loss of taste. Some soreness in arm b... Read more
Sudden onset of high fever (103.5), extreme weakness, fatigue, loss of taste. Some soreness in arm but not at injection site (lower down just above elbow). Fever went up (102.6) and down (99.2) for the next 10-12 hours, could not sleep. No specific pains. Finally back to normal around 5 AM and no other issues.
74 2021-03-29 feeling abnormal According to Dr, the patient started feeling bad 2-3 days after vaccine and tested positive for Covi... Read more
According to Dr, the patient started feeling bad 2-3 days after vaccine and tested positive for Covid-19 on 3/15 and is now in the ICU.
74 2021-03-30 poor quality sleep 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 feeling abnormal, disturbance in attention About 3 hours after receiving the vaccine, I felt extremely tired and heavy as if I weighed 300 poun... Read more
About 3 hours after receiving the vaccine, I felt extremely tired and heavy as if I weighed 300 pounds. I needed to sit down because I felt I would faint or pass out and would have not been able to get the rest of the way home had my sister not been with me. She had also just received the same vaccine and was feeling the exact same. Once home I went to sleep with a what felt like a slight fever . (My sister had shivering chills and chattering teeth.) I am now on day five after the vaccine and still have a feeling of extreme fatigue, sluggishness, inability to concentrate fully without a dizzy or spacey feeling that is accompanied by nausea. My sister feels the same. The symptoms are diminishing daily but only slightly. Throughout the past few days I?ve been so excessively tired I?ve slept 15- 12 hours a night. I realize these symptoms are not as serious as others might have but they could have led to injury had I not been accompanied by another. Thank you, I am a strong supporter of the vaccine and remain so.
74 2021-03-31 feeling abnormal feels pretty sick; stomach is really bad; foggy in the head; headache; very severe back pain; A spon... Read more
feels pretty sick; stomach is really bad; foggy in the head; headache; very severe back pain; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events very severe backpain/back pain , feels pretty sick/illness, stomach is really bad/abdominal discomfort, foggy in the head/feeling abnormal, headache. The patient's medical history included sick for 5 month with a novel virus a few years ago. Current condition included asthma. Concomitant medications included gnucola for the lungs, this helped her with her asthma. On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 039K20A) via unknown route for prophylaxis of COVID-19 infection. On 9 Feb 2021, the patient experienced the events very severe backpain. On an unknown date, the patient experienced the events feels pretty sick, stomach is really bad, foggy in the head, headache. Treatment details included Charcoal, acetylsalicylic acid. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), very severe backpain, feels pretty sick, stomach is really bad, foggy in the head, headache was unknown.; Reporter's Comments: This case concerns a 74 Y/O F with a serious unexpected back pain, illness, feeling abnormal, headache, abdominal discomfort. Event onset Day 2 after first dose mRNA-1273. Treated with charcoal, acetylsalicylic acid. Event outcomes unknown. 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 feeling abnormal pt complained of having neurological symptoms the day of the vaccine and the next day. States she wa... Read more
pt complained of having neurological symptoms the day of the vaccine and the next day. States she was having pain and tingling on her left side along with vertigo and just feeling off.
74 2021-04-01 confusional state Patient began to feel confused and dizzy after receiving the vaccine and had gait ataxia. Patient st... Read more
Patient began to feel confused and dizzy after receiving the vaccine and had gait ataxia. Patient states that she saw her dog run out the door of her home and she attempted to get him and fell down 6 flights of steps. Patient states that she landed on her back and hit her head on the ground yesterday. Patient was able to crawl into her house. Patient also c/o: headache, bilateral knee pain( L>R). acute HA, rhabdomyolysis
74 2021-04-01 feeling abnormal high fever, weakness, thinking not clear
74 2021-04-01 feeling abnormal T/C to Pt. States that she received her first dose of Moderna 03/19/21 and a couple hours later she ... Read more
T/C to Pt. States that she received her first dose of Moderna 03/19/21 and a couple hours later she got really tired and went to sleep. The next day she woke up feeling okay made some coffee then felt fatigued and went back to bed. For 2 days after the immunization she had pain accros her stomach. No diarrhea. States she does not have an appendix, but does still have her gallbladder. Has had no appetite and states she hardly ate or drank anything for 4 days. She states that she was not nauseous, but all of a sudden had this "strange feeling of indifferent to life". States that her "mind felt fuzzy for about 7 days." Fatigue lasted for about 7 days. All she has been eating is soup, saltine crackers, and drinking Pedialyte. She states that the symptoms have slowly faded away, but even now she is having low energy and trouble with appetite. Pt declined appt with PCP for evaluation.
74 2021-04-05 feeling abnormal Quick background: since childhood I have tended toward having paradoxical reactions to medications. ... Read more
Quick background: since childhood I have tended toward having paradoxical reactions to medications. About 16 days after the first Moderna shot, I woke up feeling odd, and within an hour had the worst chillls of my entire life?from head to toe, so violent that my teeth were banging against each other. I also had nausea, the runs, and extreme weakness, especially in the thighs. It took about 4-5 hours (with Tylenol and heating pad) for chills to subside, but the other symptoms lasted all day. The following day I felt a bit better, but in the morning couldn't sit at the computer because my thighs were aching and shaking so badly. The weakness was somewhat abated, but the nausea and the runs have continued.
74 2021-04-06 mental status changes Pt tested positive for COVID-19 57 days post vaccination. Pt experienced altered mental status.
74 2021-04-07 feeling abnormal 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 2021-04-08 disturbance in attention, mental status changes, memory impairment, confusional state, feeling abnormal 3/30/2021 mental confusion, zoned out, unable to recall events that happened that day. 3/31/2021 dif... Read more
3/30/2021 mental confusion, zoned out, unable to recall events that happened that day. 3/31/2021 difficulty remaining focused, brain fog, memory problems, unable to walk using cane or walker. co-ordination problems, needed to use wheel chair to move her from room to room. 4/1/2021 Appointment with primary care doctor, no improvement. Plans to order CT scan. 4/2/2021 no improvement. 4/3/2021 fell trying to get into bed, called 911 for assistance. 4/3/2021 stroke like symptoms, altered mental status, called 911 transported to ER. Remained in ER from 4/3/2021 thru 4/5/2021. 4/5/2021 combative with ER doctors and nurses, moved to private room. 4/6/2021 released from hospital, still combative, memory issues, co-ordination and mobility issues.
74 2021-04-09 anxiety Choking; arm was really sore; Feels sleepy all the time; retching/gagging; Feels tired/fatigue; Anxi... Read more
Choking; arm was really sore; Feels sleepy all the time; retching/gagging; Feels tired/fatigue; Anxiety; Cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHOKING (Choking) 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. Concurrent medical conditions included Pulmonary arterial hypertension since 12-Feb-2021 and Anxiety since 04-Mar-2021. Concomitant products included TREPROSTINIL SODIUM for Primary pulmonary hypertension. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. In February 2021, the patient experienced COUGH (Cough). On 04-Mar-2021, the patient experienced ANXIETY (Anxiety). On an unknown date, the patient experienced CHOKING (Choking) (seriousness criterion medically significant), PAIN IN EXTREMITY (arm was really sore), SOMNOLENCE (Feels sleepy all the time), RETCHING (retching/gagging) and FATIGUE (Feels tired/fatigue). At the time of the report, CHOKING (Choking), PAIN IN EXTREMITY (arm was really sore), SOMNOLENCE (Feels sleepy all the time), ANXIETY (Anxiety) and FATIGUE (Feels tired/fatigue) outcome was unknown and COUGH (Cough) and RETCHING (retching/gagging) was resolving.; 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.
74 2021-04-09 confusional state Soreness, swelling, and itching at the injection site Headache Virtigo Lighthead... Read more
Soreness, swelling, and itching at the injection site Headache Virtigo Lightheadedness Confusion Muscle aches
74 2021-04-11 insomnia shooting pain throughout my body, fatigue, headache, chills, insomnia
74 2021-04-11 sleep disorder Overall Rash- very itchy at night early morning day after receiving shot- can not sleep
74 2021-04-11 sleep disorder Extreme pain in left arm from elbow to neck. Pain began approximately 3 hours after shot and worsen... Read more
Extreme pain in left arm from elbow to neck. Pain began approximately 3 hours after shot and worsened to the point where I could only sleep sitting up for 4 or 5 nights.. The pain did not totally abate until 3/29. I called my doctor due to the extreme pain on March 22 for pain reduction suggestions. He advised alternating Tylenol and ibuprofen which provided some relief. I had taken both previously but not alternating doses. I had rotator cuff surgery several years ago and that pain was minimal compared to this pain.
74 2021-04-12 feeling abnormal, memory impairment 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 2021-04-13 disorientation 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 sleep disorder Subacromial bursitis, starting day after injecting persisting at >1 week. difficulty sleeping, pain,... Read more
Subacromial bursitis, starting day after injecting persisting at >1 week. difficulty sleeping, pain, unable to lift arm above head. patient reports practitioner injected high
74 2021-04-15 sleep disorder 11 hours after 2nd shot, severe skin burning sensations moving around various body parts. No fever o... Read more
11 hours after 2nd shot, severe skin burning sensations moving around various body parts. No fever or headache. Common, expected strong muscular aches. Skin burning areas were not red nor swollen. So strong I could not sleep the first night. Lasted for about 4 days, then slowly decreased to disappear on day 7. However, on April 14, same skin burning feelings reappeared, accompanied with itchy sensations in spots where not "burning". Again, no redness nor swelling. GP indicated vaccine probably triggered immune system which response activated nerves. Still going on today (April 16, but not worse). Areas affected move from scalp and face (mainly itching and tingling) to jumping any place over the body, like here and there, now and then, all the way down to feet.
74 2021-04-17 nervousness On day 5 and eating normally I developed extremely low blood sugar and felt Shakey for over an hour,... Read more
On day 5 and eating normally I developed extremely low blood sugar and felt Shakey for over an hour, and had lesser episodes of low blood sugar over the next week. I also felt chilled throughout that week. I have not experienced low blood sugar in over 40 years and never to that extent
74 2021-04-17 sleep disorder 10days post #2 jab, developed a productive cough and malaise. Productive sputum is clear and thick... Read more
10days post #2 jab, developed a productive cough and malaise. Productive sputum is clear and thick. Cough wakes me up at night. Using albuterol inhailer .
74 2021-04-18 sleep disorder, amnesia Halucinations- hearing things such as race cars, weedeaters, chainsaws, a choir. ALL hours of the n... Read more
Halucinations- hearing things such as race cars, weedeaters, chainsaws, a choir. ALL hours of the night and day. Yet couldn't hear an actual conversation with people right in front of me. Can't sleep no matter how tired. A few nights didn't even close eyes. Saw some very weird things on the ceiling at night while in bed (room was pitch black). Visual- saw things moving that really wasn't moving. Memory- trouble remembering simple things especially timing of things. Nauseated and throwing up. Head hurt. Trouble walking- couldn't stand up fully and very feeble acting A few things still going on as of today 4-19-2021
74 2021-04-19 excessive sleepiness Low grade fever, chills, lethargy, low level of nausea feeling lasted over a 16 hour period. Just di... Read more
Low grade fever, chills, lethargy, low level of nausea feeling lasted over a 16 hour period. Just didn't feel well. Slept for 14 hours. First time having a reaction to any vaccine. Shot injection site - still sore, as would be expected. (Reporting for your statistics on my age group.)
74 2021-04-19 memory impairment 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 2021-04-19 sleep disorder, impaired work ability 3 weeks after first vaccine had these symptoms: right arm, right side o Muscle that got vaccine o Sh... Read more
3 weeks after first vaccine had these symptoms: right arm, right side o Muscle that got vaccine o Shoulder o Throat—difficulty swallowing o Face—hurt to touch my hair o Head--couldn't sleep on Rt side o Neck And: cough, shortness of breath, sinusitis I had an appointment with my NP the day after 2nd vaccine was due on 03/07. I asked if I should take 2nd vaccine; she said yes. So I had it on the same arm. Since then, I have lost the use of my right hand. I'm a writer and have to type with one finger. A friend said it was a pinched nerve. Another one asked if I had done the Proprioceptive neuromuscular release for my neck. Additional information for Item 18: to turn it on or off at night. Additional information for Item 18: 3 weeks after first vaccine had these symptoms: right arm, right side o Muscle that got vaccine o Shoulder o Throat—difficulty swallowing o Face—hurt to touch my hair o Head--couldn't sleep on Rt side o Neck And: cough, shortness of breath, sinusitis I had an appointment with my NP the day after 2nd vaccine was due on 03/07. I asked if I should take 2nd vaccine; she said yes. So I had it on the same arm. Since then, I have lost the use of my right hand. I'm a writer and have to type with one finger. A friend said it was a pinched nerve. Another one asked if I had done the Proprioceptive neuromuscular release for my neck.
74 2021-04-21 feeling abnormal On march 4th 1st dose, high fever tfatigue chills 2-3 days, left armpit lymphonode tender pain for a... Read more
On march 4th 1st dose, high fever tfatigue chills 2-3 days, left armpit lymphonode tender pain for about 1 week. on april 1st, 2nd dose,felt worse,but no armpit pain. on the 7th day suddenly ear ringing, noise hearing loss. can hear louder sound with noise can not hear the word. She used to have hearing problem but never has diffeculty for communication ,never use hearing aid. she had hearing test done. The fever and bodyn ache was treated with tylenol. hearing loss treated with methylprednisonlone for 6 days. no obvious effect.
74 2021-04-24 confusional state 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 anxiety Dry mouth. Swollen tongue and tingle , lost of taste , smell, drulling , stressed and a lot of an... Read more
Dry mouth. Swollen tongue and tingle , lost of taste , smell, drulling , stressed and a lot of anxiety.
74 2021-04-25 confusional state arm more sore than with 1st vaccine dose; extreme headaches that don't respond to medication,; stiff... Read more
arm more sore than with 1st vaccine dose; extreme headaches that don't respond to medication,; stiff neck and shoulder muscles; swollen legs, ankles, feet (even if wearing support stockings); dizzy/light-headed; very tires; light-headed/dizzy; inability to focus,/ complete tasks; sore throat/drainage; times of heavy breathing to expel air in order to get oxygen into my system
74 2021-04-26 amnesia I had my 2nd shot on Monday., April 19. On Tuesday morning I had the blahs, a bit queasy, mild chill... Read more
I had my 2nd shot on Monday., April 19. On Tuesday morning I had the blahs, a bit queasy, mild chills. By noon I didn't join a Zoom meeting because I was not feeling well and shivering. My temp never went over 100.6 that I am aware of. However, my normal temp is 97.5. I crawled into bed to try and get warm. By then I was shivering, shaking badly. It became so intense that I couldn't call out to my husband. I couldn't use my cell because of the violent shaking. I don't know if I fell asleep or passed out. There were about 2 hours I could not account for. I still had chills and slight shivering when I woke up. I had fever for 3 days and felt exhausted. It was so scary. It was so extreme and totally unexpected. I feel like I need to report this reaction.
74 2021-04-27 anxiety Pt c/o nausea 14 mins after receiving first dose of the vaccine. She denies any past medical Hx and ... Read more
Pt c/o nausea 14 mins after receiving first dose of the vaccine. She denies any past medical Hx and noted that she ate this AM. She was assessed and monitored by NP, EMT, and paramedic. Initial BP - 142/101, HR - 90, O2 sat 97% on RA. She had mild anxiety.
74 2021-04-28 amnesia On Thursday, April 22, I lost an hour and half of memory. This was an active hour and did not remem... Read more
On Thursday, April 22, I lost an hour and half of memory. This was an active hour and did not remember and still do not recall. I had only that one episode.
74 2021-04-28 confusional state, excessive sleepiness 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 loss of personal independence in daily activities, sleep disorder Approximately 4 weeks after first dose of Moderna vaccine, patient began to experience constant whoo... Read more
Approximately 4 weeks after first dose of Moderna vaccine, patient began to experience constant whooshing sound in left ear that wakes her from sleep and is extremely distracting and disruptive to daily life activities. The symptoms are consistent with tinnitus. The patient went to see an ENT specialist who she sees for ongoing care. She had visited the provider in 2020 and had her hearing screened. Her hearing was normal at the time in both ears. The patient visited her ENT in early April 2021 for the ear symptoms. The provider found no causes of the symptoms during her examination (ie: ear wax, issues with ear drums, etc) in either ear and scheduled a follow up MRI to assess whether the patient may have a brain tumor. Additionally, the provider conducted a hearing test and discovered that the patient's hearing acuity in her left ear is 10% below normal. So it has degraded since the visit in 2020. The patient has additional specialist follow up scheduled with a otolaryngologist to assess alternate causes of the symptoms, which have not abated and which are extremely distressing to the patient. The constant sound in the patient's left ear has continued for approximately 10 weeks at this point, and she frequently experiences a feeling of distracting pressure in her left ear as well.
74 2021-04-30 feeling abnormal, excessive sleepiness Sleepiness sore arm and just feeling awful. Sleep almost all day
74 2021-05-02 feeling abnormal Experiencing post vaccine: headaches; chills; brain fog; muscle aches; arthritis more painful; leth... Read more
Experiencing post vaccine: headaches; chills; brain fog; muscle aches; arthritis more painful; lethargy;
74 2021-05-05 feeling abnormal Pt stated she had double vision and felt lightheaded and unstable. EMS called pt assessed but refuse... Read more
Pt stated she had double vision and felt lightheaded and unstable. EMS called pt assessed but refused treatment. Left in private vehicle.
74 2021-05-11 feeling abnormal, confusional state 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 2021-05-17 feeling abnormal 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 2021-05-23 feeling abnormal Dizziness, brain fog, weakness, sever indigestion, headaches (lasting more than 3 days)
74 2021-05-23 excessive sleepiness About 7:00 on the 22nd, I started to get chills. At 9:00 pm, I started to feel tired and went to bed... Read more
About 7:00 on the 22nd, I started to get chills. At 9:00 pm, I started to feel tired and went to bed. It was 79 in our bedroom. I wore a warm nightgown and added an extra blanket. Again, I slept fitfully. My symptoms were very much like my symptoms after my 1st vaccine. I virtually slept through the day on Sunday. I got up around 5. I wore a sweatshirt and had a blanket wrapped around me. I felt achy and my head ached. I was nauseous. I drank water and ate a popsicle. Again, I went to bed about 9 with an extra blanket. Monday, I was still tired and nauseous, but felt better as the day went on. I think I should be fine tomorrow.
74 2021-05-23 excessive sleepiness At about 6 pm, I was very tired and not hungry. I went to bed soon after. I slept fitfully because I... Read more
At about 6 pm, I was very tired and not hungry. I went to bed soon after. I slept fitfully because I had the chills. The next day (Sunday), I was achy, had a headache, felt nauseous, tired and virtually slept the day away (not eating). I started to perk up Monday and felt much better by supper time.
74 2021-05-24 feeling abnormal left radial fractures; hit left side of face - vein to eye; fell; felt terrible; This spontaneous ca... Read more
left radial fractures; hit left side of face - vein to eye; fell; felt terrible; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RADIUS FRACTURE (left radial fractures) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical history reported. Concomitant products included OMEPRAZOLE 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 FEELING ABNORMAL (felt terrible). On 06-Mar-2021, the patient experienced RADIUS FRACTURE (left radial fractures) (seriousness criterion hospitalization), FACE INJURY (hit left side of face - vein to eye) and FALL (fell). On 06-Mar-2021, FACE INJURY (hit left side of face - vein to eye) and FALL (fell) had resolved. On 07-Mar-2021, FEELING ABNORMAL (felt terrible) had resolved. At the time of the report, RADIUS FRACTURE (left radial fractures) outcome was unknown. Not Provided No treatment details were reported. Was seen in ER x 2 visits , 8-Mar-2021 This case was linked to MOD-2021-137773 (Patient Link).
74 2021-05-24 insomnia She got her vaccine, her arm hurt, swollen. She seemed to be fine all day except close to bedtime, ... Read more
She got her vaccine, her arm hurt, swollen. She seemed to be fine all day except close to bedtime, around 10:30/11:00 she started getting body aches, her neck hurt, her head hurt and every muscle in her body hurt. She tried putting a cold pack on her neck and did not sleep at all that night. It took her a couple of days to recuperate. Then finally the symptoms went away. She used cold packs and Tylenol, just couldn't sleep. Since the symptoms have gone she is able to sleep better.
74 2021-06-05 mental status changes, loss of personal independence in daily activities First Moderna vaccine #1 on 3/8/21 and second Moderna vaccine #2 on 4/8/21. About 4 weeks after rece... Read more
First Moderna vaccine #1 on 3/8/21 and second Moderna vaccine #2 on 4/8/21. About 4 weeks after receiving vaccine dose #2, patient (who was previously healthy) presented to the hospital with about 3-4 weeks of acutely altered mental status and rapid decline in cognitive function and ability to perform ADLs after previously having normal cognitive function. Also found to have new, acute left arm weakness with new isolated radiculopathy and de-innervation on neurologic testing. See by multiple specialists at hospital, including neurologist, rheumatologist, and hematologist. Definitive diagnosis still unclear but on the differential diagnosis discussed by medical team is secondary Sjogren's Syndrome with CNS involvement accelerated by immune activation soon after receiving 2nd Moderna dose. Unclear if there is actual relationship with vaccine but could be possible given the timing of vaccine administration and onset of patient's symptoms.
74 2021-06-10 impaired work ability I had a rash all over my body that would come and go. It was unpleasant but not painful I had extrem... Read more
I had a rash all over my body that would come and go. It was unpleasant but not painful I had extreme fatigue, body and joint aches headaches. It was very similar to when I had Lyme disease. It has recently cleared up. I was unable to work for 3 weeks. My acupuncturist gave me Chinese herbs and acupuncture treatments. That treatment was helpful. My primary care doctor only recommended rest and liquids. For the rash, she recommended Benadryl. This lasted until the end of May/beginning of June, about 3 months.
74 2021-06-12 hallucination HEARD NOISES, HAD HALLUCINATIONS, AND HAD HEADACHES PATIENT CURRENTLY HAD A UTI AND WAS EXPERIENCIN... Read more
HEARD NOISES, HAD HALLUCINATIONS, AND HAD HEADACHES PATIENT CURRENTLY HAD A UTI AND WAS EXPERIENCING SYMPTOMS FROM IT.
74 2021-06-13 amnesia Approximately 2-3 weeks after 2nd shot, I had what might have been a 'silent migrane', dancing, dazz... Read more
Approximately 2-3 weeks after 2nd shot, I had what might have been a 'silent migrane', dancing, dazzling 3-D prisms at bottom of both eyes, followed by pain on top left side of head from top of skull to the front. This happened 2 more times over the next month or so. The 4th time, it was just the prisms. I have also noticed more discomfort on the left side of my head...not quite a headache, but not exactly right. Since then I have noticed a decrease in short term memory: putting something down and not remembering where it is; thinking of something that needs to be done and then forgetting it shortly thereafter; not being able to remember a wanted word; typing a wrong word. Since I have never had any sort of migraine in my life, I think these events are connected to the Moderna shot I received.
74 2021-06-16 disturbance in attention, anxiety, feeling abnormal 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 2021-06-19 mental impairment STARTED DAY OF INJECTION 6/10/21. HURTS, ARM, INFLAMMED, SWOLLEN, OVER 6 INCHES OF AREA AROUND INJEC... Read more
STARTED DAY OF INJECTION 6/10/21. HURTS, ARM, INFLAMMED, SWOLLEN, OVER 6 INCHES OF AREA AROUND INJECTION SITE AFFECTED, INJECTION SITE IS STILL RED WITH SERUM LEAKING. MENTAL CLOUDY OCCASIONALLY. NO COMPLAINTS OF SHORTNESS OF BREATH
74 2021-06-20 feeling abnormal, sleep disorder I felt okay earlier in day after vaccine, but then I sat down in living room at about 7PM at night a... Read more
I felt okay earlier in day after vaccine, but then I sat down in living room at about 7PM at night and I woke up about 3AM in the morning and my muscles ached and joints ached and so I thought I better go to bed. I was also having very bad chills and sweating and I couldn't get warm and had to put on 3 blankets in the bed. I had a headache and finally I fell back asleep and didn't wake up until 4PM the next day (02/20/2021) and I still felt pretty bad but I wasn't as achy or shaky or sweaty. I felt really weak and then by Saturday I went to bed around 8PM, woke up around 10AM the next day (02/21/2021) and felt more normal. Over the next couple of weeks, I had some headaches and I attributed them to dehydration but it could be related to vaccine. I also had skin problems that I never had before. I had joint aching but it wasn't constant and it would come and go. I am still having skin problems on my back and my shoulders. There's itchy bumps. Has not seen medical doctor but there is appointment in July with PCP. I couldn't lay on left side because of arm pain.
74 2021-06-24 depression 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 2021-06-24 loss of personal independence in daily activities She got her vaccine, she had an area approximately about 5" x 4" across on her arm, quite raised, ve... Read more
She got her vaccine, she had an area approximately about 5" x 4" across on her arm, quite raised, very very red, it hurt, painful and itchy. It lasted for a week to 10 days up to 2 weeks at the site of the injection. I experienced achiness, malaise for several days afterwards, and kind of continued for about 3 weeks before it settled down. She treated it with Tylenol, bed rest and Motrin. She had gone to her PCP with the first vaccine which I will describe later. She used to be very active and she now cannot walk trails, and still has the feeling of malaise 4 months post vaccine. She feels she is still having some inflammatory ongoing process in her muscles, joints and has had three short courses of steroids over the last couple of months, and is now in physical therapy and going to be seen by an Orthopedist again to see what may be going on. She is a retired nurse and feels that now she has a permanent condition based on having the vaccine, and does not know if she would have a booster if it was offered, and her quality of life has changed and is "no way to live".
74 2021-06-27 insomnia Horrible cough, hard time sleeping, wheezing
74 2021-06-28 sleep disorder Chronic pain continues in left arm, pain prevents sleep & unable to lift arm above head Doctor pres... Read more
Chronic pain continues in left arm, pain prevents sleep & unable to lift arm above head Doctor prescribed Methylprednisolone for pain.
74 2021-07-03 impaired work ability STARTED RUNNING FEVER ON 2ND DAY. RAN FEVER FOR A WEEK. I FELT LIKE I WAS GOING TO DIE. BECAME DEHYD... Read more
STARTED RUNNING FEVER ON 2ND DAY. RAN FEVER FOR A WEEK. I FELT LIKE I WAS GOING TO DIE. BECAME DEHYDRATED AND SPENT A DAY IN ER. THEY RAN ALL KINDS OF TESTS AND FOUND NOTHING THE MATTER OTHER THAN A SEVERE REACTION TO THE SHOT. THEY RECOMMENDED I NOT GET THE 2ND SHOT. I WAS VERY WEAK FOR THE NEXT 2 WEEKS AND MISSED 3 WEEKS FROM MY JOB. I STILL AM HAVING PERIODS OF WEAKNESS.
74 2021-07-15 loss of personal independence in daily activities, insomnia Pain, stiffness, and weakness began in left hip. Arms were weak also. Eventually moved to both hip... Read more
Pain, stiffness, and weakness began in left hip. Arms were weak also. Eventually moved to both hips, groins, arms, hands, neck, jaw, collar-bone area. Was almost totally incapacitated -- couldn't get up from chair, toilet, or bed, couldn't sleep in bed because of pain, needed help getting dressed, couldn't go up and down stairs, couldn't drive, couldn't do normal household chores, extreme fatigue. Doctor ordered lab work and determined I had Polymyalgia Rheumatica -- which I never had before. Never had any rheumatic disease. She prescribed 15 mg daily Predisone and Hydrocodone. Within two days, symptoms eased considerably. After taking for two weeks, much improvement so she had me cut Predisone to 10 mg; however, symptoms began coming back. So back on 15 mgs. again. Now, two weeks later, symptoms are basically gone. Talked to doctor again today. She is having me cut back on Prednisone more slowly -- only 1 mg at a time over a longer period. My left hip started bothering me approximately on March 1, 2021. By the first part of May, it had spread to all the parts of my body listed above. I contacted doctor approximately on 6/1/2021 and started taking Predisone. I talked to her again 6/11/2021 and 7/15/2021.
74 2021-07-20 excessive sleepiness Lost feeling in left leg, night sweats , cold sweats, nausea, diarrhea, long sleep times, no energy,... Read more
Lost feeling in left leg, night sweats , cold sweats, nausea, diarrhea, long sleep times, no energy, slightly short of breath
74 2021-07-22 loss of personal independence in daily activities, disturbance in attention Client contacted on 7/14/2021 reporting after first COVID shot on 4/14/2021 about 24 hours later fel... Read more
Client contacted on 7/14/2021 reporting after first COVID shot on 4/14/2021 about 24 hours later felt very dizzy and couldn't sleep enough. Headahche, chills unbalanced when walk. Falling asleep while driving. Have Psoriasis, very sensative to medicines historically. Uses inhaler. Can't breath well uses inhaler 2x per day. Has seen PCP. Symptoms were no strength to stand long lengths of time Can hardly go to grocery store. Sits in chair at work is Administrative position. Can't concentrate well . Tested for COVID 4x all negative per report to this RN. Reported started to feel better about 5 weeks after initial COVID vaccine and decided to get 2nd dose after consulting with PCP. (No mention of this in clinic notes for dose #2 on 5/26/2021). Only reported hx. of Psoriasis. Reports a day or two later after 2nd dose started getting symptoms again. Denies any lab work or tests completed or ordered by her PCP mentioned above. Reports looking for another Dr. Reports called doctor and was prescribed Ivermection. Denies knowledge of VAERS report completed by PCP. This RN discussed all of the above information w/ Doctor who encouraged client to f/u with PCP.
74 2021-07-28 loss of personal independence in daily activities Myalgia, started with moderna dose 2, recovered somewhat then recurred March 2, 2021 Physical thera... Read more
Myalgia, started with moderna dose 2, recovered somewhat then recurred March 2, 2021 Physical therapy, steroid injection, analgesics. Limited ADL and function. Scheduled appointment with rheumatologist on 8-6-21
75 2021-01-03 fear, feeling abnormal Pt. co of feeling flushed and feeling funny. Patient was flushed and b/p 142/80 r arm. Pt observed 1... Read more
Pt. co of feeling flushed and feeling funny. Patient was flushed and b/p 142/80 r arm. Pt observed 10 mins and she sated that she was feeling worse and scared . No noted shortness of breath. B/p rechecked 110/80.
75 2021-01-10 anxiety Patient observed for 15 minutes post vaccination felt fine, left the area; however, as she was drivi... Read more
Patient observed for 15 minutes post vaccination felt fine, left the area; however, as she was driving home she felt lightheaded, anxious, feeling flushed, tingling in head that comes and goes. Patient cleared by EMS. Instructed patient to sign up for v-safe, contact her primary care physician for direction. Patient advised to call 911 or go to the nearest emergency room for any further issues.
75 2021-01-13 insomnia 1/12: Nausea, mild vomiting (reflux), pain at injections site 1/13: More pain at injection site, nau... Read more
1/12: Nausea, mild vomiting (reflux), pain at injections site 1/13: More pain at injection site, nausea, mild vomiting, fever 99.7F, headache, sleeplessness 1/14: Less pain, no more nausea or fever
75 2021-01-14 agitation 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 2021-01-17 nervousness 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 2021-01-19 agitation Patient confirmed she had no history of severe allergic reaction to a prior vaccine or any of the i... Read more
Patient confirmed she had no history of severe allergic reaction to a prior vaccine or any of the ingredients in the Moderna vaccine prior to vaccination which was performed 1/7/2021 without complications and she was observed for 15 minutes post vaccination without any adverse reaction. Her husband reported that she was well until the evening following her vaccination (1/08/2021) at which time she became agitated. The following day she became very fatigued and unresponsive, taking only sips of water. The only medical attention they sought at this time was a home health hospice nurse as the patient had been on hospice. Her condition spontaneously improved without treatment after 3 days and 6 days after her vaccination she was at her normal baseline.
75 2021-01-21 sleep disorder, loss of personal independence in daily activities After the shot, I went home and felt fine. I did some housework (cleaning) for about thirty minutes... Read more
After the shot, I went home and felt fine. I did some housework (cleaning) for about thirty minutes, then sat to rest . Shortly thereafter, I began feeling pain in my left arm. The pain became more severe as the day progressed until it was very severe and movement of my arm was limited. The pain progressed throughout the night and also moved into my shoulder. I got very little sleep even after taking Tylenol and trying heat and ice applications. Now, on the third day I am still having pain and am unable to lift my arm or move it outward without severe pain. I am definitely hindered in my movement and use of left arm. This is disturbing as I am an artist and need both arms to do my work.
75 2021-01-24 feeling abnormal Foggy--increased monitoring for 25 minutes.
75 2021-01-25 delirium 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 anxiety 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 2021-01-27 feeling abnormal 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 2021-01-27 loss of personal independence in daily activities Still having a fever after a week , which has been as high as 101 Degrees, also having some chills ... Read more
Still having a fever after a week , which has been as high as 101 Degrees, also having some chills ,also feeling very tired and not able to do much. I also still have a place showing where the vaccine was given in right arm.
75 2021-01-30 loss of personal independence in daily activities Severe pain radiating throughout entire body. Each join in her extremities. Unable to perform nor... Read more
Severe pain radiating throughout entire body. Each join in her extremities. Unable to perform normal daily functions (ie shower, walking, etc.)
75 2021-02-01 insomnia Zero discomfort at injection site or for 4 hours after, but at almost exactly 4 hours +one minute, u... Read more
Zero discomfort at injection site or for 4 hours after, but at almost exactly 4 hours +one minute, upper portion of left arm became unusable. Could not lift arm, or support even as much weight as a tissue. Could not pull pants up. Needed help changing clothes. Unable to sleep that night. Symptoms persisted through next day, but began to resolve very gradually 24 hours after onset. By day 4, arm was back to normal. However, 7 days after injection, woke up with arm unusable again. Same time progression -- arm non-functional and extremely uncomfortable (not excruciating, but very intense) for about 24 hours. Another night of no sleep. Gradual improvement over 3 days. Pain was largely confined to muscles in upper arm, but radiated partially up left side of neck, and occasionally down into lower arm. A small price to pay for not getting the virus though! No other aches, pains, fever or nausea.
75 2021-02-01 loss of personal independence in daily activities chills and fever beginning on Jan 29 around 1PM and continuing through the night. Bedtime temp 99.9... Read more
chills and fever beginning on Jan 29 around 1PM and continuing through the night. Bedtime temp 99.9; waking temp 97.4 which is normal for me. Did my normal breakfast Jan 30 followed by a 4-mile walk and felt fine. Mid-day temp 97.8 so no worries. Bedtime temp 100.1 plus ice cold hands and feet. Had profuse sweating during night but would experience feeling cold. Waking Jan 31 temp 99.3. Rested during day. Mid-day temp 98.6. Bedtime temp 99.9 with chills through the night. Feb 1 awakening 98.7. The lingering side effects that interfered with my regular routine began to alarm me so I emailed Dr. Because of the window of time we were in relative to the inoculation, he is viewing it as an extended side effect and advised to watch for other symptoms. To date I have no other symptoms yet these chills and fever have continued all day Feb 1 and Feb 2. Beginning Feb 1 I have kept a log of hourly temperatures. I have not taken anything to attempt to bring down the fever. On Feb 1 my temperature began to rise at 1PM with 99.0 and by bedtime it was 100.5. On Feb 2, today, I rose with 99.2 and ranged to 97.8 which seems aberrant because the other temps are all in the 98's or 99's. The chills in the morning and early afternoon do not seem as noticeable as the ones in the evening.
75 2021-02-04 disorientation episode of transient global amnesia (TGA) lasting approximately 3.5 hours1 resolving after Observat... Read more
episode of transient global amnesia (TGA) lasting approximately 3.5 hours1 resolving after Observation no treatment. symptoms included amnesia to events leading up to vaccination and post vaccination, disorientation to time and place and situation
75 2021-02-06 insomnia 2/2 8 am to 2/3 8 am . After a restless night, I woke up feeling achy all over. It was hard to get... Read more
2/2 8 am to 2/3 8 am . After a restless night, I woke up feeling achy all over. It was hard to get up but I went to the couch for the rest of the day. I ate nothing. I took no meds. I sleep intermittently. At 6 pm I had a fever of 100.1 that lasted about 2 hours. No headache, no actual pain on body or at shot site. Just achy.
75 2021-02-06 sleep disorder, feeling abnormal 12 hours after vaccination I had swelling and severe pain upper left arm, severe muscle and joint ac... Read more
12 hours after vaccination I had swelling and severe pain upper left arm, severe muscle and joint aches and headache, loss of appetite. Woke me around 3:00 AM, lasted 2 days. 3rd day felt washed out and hollow, head still feels swollen. Unable to move out of bed for 2 days due to pain. Drank lots and lots of water to flush out of system. Am in between doctors right now and was to out of things to call anybody. Don't really want the 2nd vaccination due to the more severe effects 2nd doses are having on others. COVID symptoms twice in my life is more then enough.
75 2021-02-08 disorientation Client became disoriented to place and time
75 2021-02-09 feeling abnormal The injection was at 1:00 p.m. The next morning when I awoke, I did not feel well, though without pa... Read more
The injection was at 1:00 p.m. The next morning when I awoke, I did not feel well, though without particular symptoms. I felt exhausted and stayed in bed. In a short time, I had a severe headache and upset stomach. Later, muscle pains in my thighs felt as though I were being hit with a bat. I had no appetite and no energy to get up, even to take an OTC pain reliever. By 2:00 or 3:00 in the afternoon, I was able to get up, take ibuprofen, and drink tea. In early evening, I ate something--can't remember what--as the pain was gone. I went to bed at about 8:30 and slept 12 hours. I was essentially all right after that, though at times felt "puny," as we say in the South. I had NO adverse side effects with the first inoculation.
75 2021-02-09 sleep disorder I woke Sunday at 5AM after shot on Saturday at 1 PM with really bad headache. took 2 Ibuprofen . w... Read more
I woke Sunday at 5AM after shot on Saturday at 1 PM with really bad headache. took 2 Ibuprofen . went back to bed. Was able to sleep. Woke about 8:30 AM and felt I needed to check my temperature. It was 99.9 and I have run about 97.6 normally for several yrs now. My left arm where shot was given was swollen about size of a walnut, with a red rectangle which lasted through Tuesday. Arm still somewhat swollen on Wednesday-today. I didn't feel rea well Sunday thru Tuesday. Arm still bit swollen on Wednesday , redness is gone .
75 2021-02-11 anxiety tremors worsened. anxiety.
75 2021-02-14 loss of personal independence in daily activities 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 2021-02-15 sleep disorder 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 2021-02-16 sleep disorder Woke up st 2 am w sweating and severe pain in left frontal head. Spasm about 30 seconds apart for 5... Read more
Woke up st 2 am w sweating and severe pain in left frontal head. Spasm about 30 seconds apart for 5 minutes. Had to pass a stool as well. Next day hurt to even chew on that side or lie on left side and residual pain in affected are (not a headache) day three pain in head subsided
75 2021-02-17 sleep disorder L arm pain started after vaccine, resolved and then restarted a week later affecting sleep exacerbat... Read more
L arm pain started after vaccine, resolved and then restarted a week later affecting sleep exacerbated by pressure in area
75 2021-02-18 insomnia Burning and itching sensation on my back beginning on Saturday evening, February 6... 2 days after t... Read more
Burning and itching sensation on my back beginning on Saturday evening, February 6... 2 days after the vaccine shot. Got worse by Sunday evening with feelings of all nerve endings exposed and ?creepy crawling? on my right arm. Unable to sleep. Saw dermatologist, Doctor on Tuesday morning. Prescribed Triamcinolone Acetonide topical cream. Did not think it was shingles at the time. I have used the cream for 10 days... the itch and pain have gotten worse. Today, texted her pix of the area on my back - under right shoulder blade and two spots on my right breast. She diagnosed shingles for sure and prescribed Valacyclovir - 21 tablets -3 x a day for 7 days. I have now begun that protocol. Once I saw Doctor.... stabbing pains began under my right shoulder blade....saw primary doc., Doctor.. she too did not think it was shingles at the time.... prescribed a muscle relaxant- it did not help... stopped taking it after two doses I am worried about getting dose 2
75 2021-02-19 feeling abnormal, amnesia, loss of personal independence in daily activities My mother, the patient, received the shot at 3:00 pm on a Wednesday. By 3:00 am Thursday morning, my... Read more
My mother, the patient, received the shot at 3:00 pm on a Wednesday. By 3:00 am Thursday morning, my mother became very weak and was unable to walk to the bathroom. She needed to be carried. The next morning she was very weak and needed to be dressed. She was also very subdued and "loopy". She ate breakfast and hearty bean soup for lunch, but by 4:00 pm Thursday she became nauseous and was running a low fever around 99. We gave her a NyQuil dose which she quickly vomited. From there she continued to vomit and her temperature went up. When she needed to use the restroom, I escorted her, but by the time we reached that area she could not follow instructions to sit down and was holding onto the door jamb. She had soiled herself while standing there. Eventually I was able to get her to sit down and was able to clean her up and change her clothes. But she could not follow instructions to stand up. With a second caregiver, we were able to get her to stand up, but within three steps of the toilet her knees buckled and she was unable to stand. We sat her in a walker with a seat and rechecked her temperature. It had gone up to 103. At this time, we considered calling 911, but instead we put a cool cloth on the back of her neck and monitored her (with three people all standing round). After a while we were able to move her back to the family room where she insisted upon sitting on the couch. She was able to stand up from the walker and move a few steps to the couch. By 10 pm she was starting to drift off to sleep sitting up and her temperature was back down around 99. When we were putting her to bed, she had no memory of where the clothes had come from or why she was not in her original outfit. Following that she slept and did not have another worrisome episode. She did complain of her arm hurting for several days and that it was itchy at the injection site. I did not observe any swelling or rashes on her.
75 2021-02-20 feeling abnormal Wednesday : No energy, Chills, Fever 101.7, degrees, Injection site swollen and sensitive to touc... Read more
Wednesday : No energy, Chills, Fever 101.7, degrees, Injection site swollen and sensitive to touch, joints & muscle pain all the time, HEADACHE, left out of it like I had been hit by a truck. Took Tylenol, drank lots of liquids, slept, miserable Thursday: Chills, Fever around 100.8 degrees, chills, headache, some joint and muscle pain, runny, stuffy nose and some coughing, Injection site still sensitive to touch and swollen. Had a little energy today. and more aware of surrounds. Tylenol, drank lots of liquids, Firday: No temperature and feel some better, but still some of all the problems.
75 2021-02-21 delirium, mental impairment, poor quality sleep Woke up about 1:00 am in delirium and feverish. No control over thought process or able to get up. M... Read more
Woke up about 1:00 am in delirium and feverish. No control over thought process or able to get up. Managed to get out of bed at 9:00 am but was so weak could barely make it up a flight of stairs. And when I did ended up in bathroom vomiting. Laid on floor to get some strength back. Went back to bed and slept restlessly until 4:00 pm. Still feverish and weak but not as bad as earlier. Ate some cold grapes and went back to bed until the following morning. Tried to stay hydrated and took ibuprofen several times. My upper arm was red and blotchy for 3 days. Overall I?d say the severest part of the event lasted 48 hrs and another 24 hrs of tiredness and nausea but not vomiting.
75 2021-02-21 excessive sleepiness Nausea, vomiting, Fatigue, headache, muscle pain, chills , lack of appetite -drank only water until ... Read more
Nausea, vomiting, Fatigue, headache, muscle pain, chills , lack of appetite -drank only water until 2-6. excessive sleeping.(day and a half). No treatment- After vomiting about 36 hours after vaccine, felt better. No fever
75 2021-02-22 disorientation, amnesia Disorientation, temporary loss of memory, headache lasting 12-36 hours
75 2021-02-22 feeling abnormal LARGE RASH AND SORENESS AT INJECTION SITE ---WARM SENSATION , ITCTING SWELLING & UNSETTLING AND AGRA... Read more
LARGE RASH AND SORENESS AT INJECTION SITE ---WARM SENSATION , ITCTING SWELLING & UNSETTLING AND AGRAVATED FEELINGS THROUGH-OUT THE DAY
75 2021-02-22 insomnia headache, muscle aches, pain at injection site, sensitivity to touch--prickly skin, severe elbow and... Read more
headache, muscle aches, pain at injection site, sensitivity to touch--prickly skin, severe elbow and shoulder pain--both sides, insomnia, 100 degree fever approximately 18 hours after shot, treated successfully with acetominophen. Symptoms still present 24 hours
75 2021-02-23 sleep disorder Pt stated that after she received the covid vax her nose was hurting and sinuses were burning. She ... Read more
Pt stated that after she received the covid vax her nose was hurting and sinuses were burning. She was not able to sleep since she had a headache and her neck was hurting. Pt took a Tylenol pm and slept some. She was nauseated w/ dry heaves. Her temp was 100.7 . She took another Tylenol pm and slept the entire night. She feels better today but has developed a rash on the top of her left arm. She still has a dry cough that she has had since her first vax. Pt will contact her PCP and schedule a virtual appt.
75 2021-02-24 confusional state Confusion, falling, inability to complete sentence
75 2021-02-24 feeling abnormal chills for 2 hours, generalized body aches( really miserable), for 12 hours, slight headache, for 6 ... Read more
chills for 2 hours, generalized body aches( really miserable), for 12 hours, slight headache, for 6 hours, intestinal cramping for several hours, fatigue for first day, decreasing the 2nd day.
75 2021-02-24 sleep disorder fever, chills, abdominal pain, swelling at sight and very sore, fatigue, headache, muscle pain, join... Read more
fever, chills, abdominal pain, swelling at sight and very sore, fatigue, headache, muscle pain, joint pain, nausea, unable to sleep
75 2021-02-26 disorientation, confusional state On the evening after her second dose she experienced disorientation, vomiting, incontinence, confusi... Read more
On the evening after her second dose she experienced disorientation, vomiting, incontinence, confusion. Symptoms persisted for days and she lay prostrate in bed. Comes to the office 6 days later, oriented x 5 but 24/30(prior mini-cog 4/5), mild elevation of LFTs and platelet clumping.
75 2021-02-26 feeling abnormal Had the shot just before 11 am Tuesday and within a few hours had nausea, by evening had headache, c... Read more
Had the shot just before 11 am Tuesday and within a few hours had nausea, by evening had headache, chills, low-grade fever (under 100). Did not take anything for it. Awakened at 3 am by pain at injection area. Wednesday, all day on couch with nausea, pain in arm, chills, low-grade fever. Took 1 Advil around noon and another before bed (temp just over 100). Woke Thursday morning in a pool of sweat, no more fever. Brain slow and foggy all day, shot area red and hot, but not painful. Friday, all good except lingering soreness in arm (to touch).
75 2021-02-27 disturbance in attention, feeling abnormal On the morning after vaccine injection, patient had moderately severe "brain fog" with inability to ... Read more
On the morning after vaccine injection, patient had moderately severe "brain fog" with inability to focus or concentrate. Reaction lasted until mid afternoon, then began to clear and by following morning was gone and patient normal.
75 2021-03-01 disorientation, feeling abnormal 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 feeling abnormal pt states that her left arm was sore for about 4 days after getting the covid vax. The next day she... Read more
pt states that her left arm was sore for about 4 days after getting the covid vax. The next day she developed severe brain fog and fatigue. She also had chills no fever, SOB, lost of taste, and nauseated. These symptoms lasted one week. The second week she began to have dizziness, lightheadedness, change in voice to where she has trouble speaking. Some days she cannot taste. She has hair loss and red rash bumps on left leg, chest, and back. Pt states she had a covid like illness from Feb 2019-mid summer 2020 and she is having the same symptoms now that she had then. Pt contacted her PCP regarding her symptoms. Pt says she is much better but still has brain fog periodically and her voice is still not normal and she can hardly speak.
75 2021-03-03 confusional state 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 2021-03-03 feeling abnormal, confusional state leg weakness and loss of control of legs that lasted about 24 hours. spouse had to pick her up for ... Read more
leg weakness and loss of control of legs that lasted about 24 hours. spouse had to pick her up for transfers. there was some muscle activation in legs but not coordinated (knee would move but foot wouldn't move at the right time). self-resolved. also some brain fog and confusion
75 2021-03-04 anxiety 75 year old complained of anxiety after receiving the vaccine. Onsite EMS was called BP 146/78 99% ... Read more
75 year old complained of anxiety after receiving the vaccine. Onsite EMS was called BP 146/78 99% O2 HR 96. She refused further evalvation & care.
75 2021-03-06 feeling abnormal pt stated she feel "off". She feels like she is going to fall asleep. Difficulty seeing, states feel... Read more
pt stated she feel "off". She feels like she is going to fall asleep. Difficulty seeing, states feels like she does not have her glasses on, Pt has pacemaker. HR 60, BP 102/70, O2 97%. EMS called
75 2021-03-06 insomnia extreme fatigue and muscle aches; sleeplessness; weak; lasted for 36+ hours; took Motrin and rested;... Read more
extreme fatigue and muscle aches; sleeplessness; weak; lasted for 36+ hours; took Motrin and rested; after 48 hours and continued Motrin am 95% recovered
75 2021-03-07 feeling abnormal 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 2021-03-08 feeling abnormal I felt like my brain and brain stem were swollen. It took at least a week before my brain began to ... Read more
I felt like my brain and brain stem were swollen. It took at least a week before my brain began to feel normal.
75 2021-03-09 agitation, depression, disturbance in attention, amnesia, anger, anxiety, confusional state As her husband, and caregiver since 2017, when she was diagnosed with dementia (I believe she had sy... Read more
As her husband, and caregiver since 2017, when she was diagnosed with dementia (I believe she had symptoms long before that) I noticed a very observable increase in the severity of her symptoms of confusion, memory loss, not being able to stay focused, disorientation, anxiety, agitation, anger, depression as a direct result of the second dose of the covid vaccine The change was very noticeable and has not gotten any better. This appears to be a permanent escalation in the severity of her symptoms. I would say she has advanced a stage to stage 5. We are now considering adding a new drug for her to take to try and level things out. She also appeared to have a slight fever for 48 hours after.
75 2021-03-09 sleep disorder I began having a reaction on the evening of 2/19 with a sore arm and scratchy throat. The next morni... Read more
I began having a reaction on the evening of 2/19 with a sore arm and scratchy throat. The next morning, I developed shaking chills, slight nausea, headache, and low grade temp 99-100. I also noticed swollen glands and muscle aches and pain in my back. That lasted about 28 hours. After that I had nerve pain in my neck and all my teeth were painful. I went to bed. I have fibromyalgia so I thought that I may be triggered into a flare. The acute symptoms subsided in a few days, but I then had intermittent sudden nerve pain, cold spells and hot flashes, a recurrence of irritable bowel like symptoms, with occasional diarrhea (uncharacteristic for my IBS-C). I had to visit my osteopath (for osteopathic manipulation) twice in two weeks for the pain. She suggested that my symptoms were more than a typical flare and that I should report to VAERS. Yesterday, 3/9 I began to feel exhausted. Last night I had severe systemic itching that kept me awake much of the night. Today the fatigue continues along with temperature dysregulation. I have contacted my PCP and am awaiting an appointment confirmation.
75 2021-03-10 confusional state Confusion, lethargy, extreme fatigue
75 2021-03-13 insomnia Approximately 1015-1030 am after receiving booster of Modena vaccine at 7:30 am I stated to get a he... Read more
Approximately 1015-1030 am after receiving booster of Modena vaccine at 7:30 am I stated to get a headache and queasy stomach. As morning progressed headache worsened . By 3:00pm I felt cold, somewhat aches and took an Advil. Felt better by 6:00pm. Stomach still felt queasy did not eat but thirsty. Tried to stay hydrated as instructed. Went to bed 10:00 pm and felt cold again. That is when I took temp 99. Headache is in full force sick to stomach and have chills and shakes really bad. Felt this way until 2:00 am. I had no sleep and felt very weak tried to get out of bed felt dizzy. Was sick all day on Wednesday the 10th took some Tylenol. Thursday the 11th woke up feeling somewhat better but still with headache and no appetite and nausea. Symptoms came and went on Thursday and Friday, Saturday headaches and nausea continued. Sunday feeling much better.
75 2021-03-13 sleep disorder Around 4:30 in the afternoon started with severe headache, chills, diarrhea and fever. This has eff... Read more
Around 4:30 in the afternoon started with severe headache, chills, diarrhea and fever. This has effected sleeping. Could not raise arm that injection was given in. These symptoms lasted through the morning of 3/14.
75 2021-03-15 feeling abnormal Sharp pain at and surrounding the injection site began within hours of receiving the vaccine. 12 ... Read more
Sharp pain at and surrounding the injection site began within hours of receiving the vaccine. 12 hours after receiving injection: sharp, stabbing, searing pain along all the nerves that radiate from L4, L5, through both hips, down and around both legs. Sharp, stabbing, searing pain in the upper back. Intense knee pain - unable to walk. Temperature of 100.2 degrees. Headache. Brain Fog. Nausea. Extreme fatigue. Loss of balance. Loss of appetite. These symptoms lasted about 36 hours. After 36 hours muscle pain all over and fatigue. At the injection site on my left arm, the pain gradually subsided and eased over a period of 96 hours.
75 2021-03-16 anxiety c/o dyspnea and fatigue; Caller reports she is still able to perform ADLs without difficulty and que... Read more
c/o dyspnea and fatigue; Caller reports she is still able to perform ADLs without difficulty and questions if sx are anxiety related scheduled herself for covid test 3/16/21 at the clinic may have been anxiety , saw doctor , everything negative .
75 2021-03-18 feeling abnormal 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 2021-03-18 sleep disorder Night following shot, I slept badly and felt cold all night. When I wanted to get up to go to the b... Read more
Night following shot, I slept badly and felt cold all night. When I wanted to get up to go to the bathroom around 5:30 AM, I could not get myself off and out of the bed. It was like my legs wouldn't work. When I was finally up, I had no control of my bladder and urinated all the way into my bathroom. When I was done on the toilet, I started to stand up and lost my balance. I tried to reach for the door jam but missed and fell backwards onto the toilet and sat hard and hit my back very hard against the top of the toilet. I helped back to bed by boyfriend but had to get up several more times that morning and had the same weakness in my legs and no control over my bladder. My boyfriend had to leave to go home, so I called my sister to come and stay with me in case I couldn't get up again. One she was here, I ate a small amount of roast chicken and slept most of the afternoon. I slept thru the night and felt stronger the next day. I felt very tired and sleepy for the next couple of days, but (3 days later) am now feeling and moving in a more normal manner.
75 2021-03-19 amnesia 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 2021-03-19 excessive sleepiness Chills for 30 minutes - fever 101.8 (not affected by Tylenol) - felt as though I weighed 500 pounds ... Read more
Chills for 30 minutes - fever 101.8 (not affected by Tylenol) - felt as though I weighed 500 pounds - limbs so heavy I could hardly lift them - Slept most of 36 hours - couldn't walk further than a few feet - didn't eat - standing was difficult - felt AWFUL - 8:00 a.m. 3/20/2021 - This morning I had a very sharp pain above my eyebrow/nose - the area is still tender to the touch. No clue what that is. No signs of stroke.
75 2021-03-22 panic reaction I developed bad chills, headache, body aches, fever, sore and swollen arm, and a feeling of panic ... Read more
I developed bad chills, headache, body aches, fever, sore and swollen arm, and a feeling of panic and helplessness for about an hour in the middle of the night. Most of the other symptoms lasted about 9 hours. After that, I still had a swollen, sore arm and a headache for about 24 more hours. Fatigue set in for a couple of days after that.
75 2021-03-23 abnormal behaviour, confusional state, anxiety, agitation 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 hallucination Fever of 100.7, her normal is around 96 extreme chills - had to use a heating pad Confusion - couldn... Read more
Fever of 100.7, her normal is around 96 extreme chills - had to use a heating pad Confusion - couldn't figure out what the thermometer was used for Hallucinations - She though she was flying around the bedroom, but had to stay above her dog, who was on the bed to protect it. Can't remember
75 2021-03-24 mental status changes Moderna vaccine #1 received on 1/14/21. On 1/15/21, the patient developed lip swelling and facial ed... Read more
Moderna vaccine #1 received on 1/14/21. On 1/15/21, the patient developed lip swelling and facial edema with no relief with benadryl and eventual relief with hydroxyzine. On 1/15/21, she had also developed shortness of breath, headache, and profound fatigue. These latter symptoms did not resolve and she was seen by her PCP on 1/19/21. Labs at that time were (see below) were concerning for inflammation/infection and she was given IM injection of ceftriaxone. She had progressive symptoms thereafter including mental status changes and inability to walk without a cane and was seen again on 1/21/21. Labs were repeated (see below) with worsening of ESR so she was hospitalized. Bilateral temporal artery biopsies performed on 1/21/21 were consistent with Giant Cell arteritis and she was prescribed corticosteroids. Her headaches, mental status changes, and all other symptoms resolved during steroid taper.
75 2021-03-28 feeling abnormal Aches lasted a week, feet so cold they turned red, headaches, and very weak. It is two weeks today a... Read more
Aches lasted a week, feet so cold they turned red, headaches, and very weak. It is two weeks today and I still am experiencing terrible brain fog. That is the worse part now. I am just laying low and doing things bit by bit.
75 2021-03-29 feeling abnormal Urinary tract infection; Allergy (anaphylaxis) to levofloxacin; Hives; Difficult breathing; Felt awf... Read more
Urinary tract infection; Allergy (anaphylaxis) to levofloxacin; Hives; Difficult breathing; Felt awful; Sluggish; Light-headed; A spontaneous report was received from a consumer concerning herself, a 75-year-old female patient, who received 2 doses of Moderna's COVID-19 vaccine (mRNA-1273) and experienced allergy (anaphylaxis) to levofloxacin (anaphylactic reaction), hives (urticaria), difficult breathing (dyspnoea), felt awful (feeling abnormal), sluggish, and light-headed (dizziness). The patient's medical history, as provided by the reporter included urinary tract infection (UTI).Medications included levofloxacin and nitrofurantoin to treat urinary tract infection. On 19 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, 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. On 05 Mar 2021, the patient took levofloxacin 500mg to treat urinary tract infection (UTI). Soon thereafter patient had a severe allergic reaction to levofloxacin. Treatment included Emergency Room drug-induced anaphylaxis treatment.Later Patient took nitrofurantoin for 5 days for the UTI and developed events sluggish, and light-headed hives,felt awful and difficult breathing. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event, allergy (anaphylaxis) to levofloxacin was resolved on 05 Mar 2021. The outcome of the event, hives, difficult breathing, felt awful, sluggish, and light-headed, were unknown.; Reporter's Comments: This case concerns a 75 Y/O F who had NS unexpected urinary tract infection and serious unexpected anaphylactic reaction with NS unexpected urticaria, dyspnea, dizziness, feeling abnormal, sluggish. Anaphylaxis on Day 18 after first dose mRNA-1273 was considered possibly related to levofloxacin for UTI. Anaphylaxis 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 2021-03-29 feeling abnormal Symptoms started on the day after the 2nd shot and continue to date. Had upset stomach, affected he... Read more
Symptoms started on the day after the 2nd shot and continue to date. Had upset stomach, affected her taste (things tasted bad when everyone else thought the food was good), loss of appetite, nauseous, chilled (used 3 blankets), ached all over, headache, couldn?t think clearly, stabbing ? sharp, jabbing pains in her muscles, even the buttocks (like someone was poking her with a knife or a fork); muscles, bones and joints ached, no energy. Was ?just ill.? Was fine after first shot. Still not well from the 2nd shot. Has a hard time walking since this 2nd shot. Takes Tylenol for relief. Was treated with antibiotic x 1 week and also Benadryl. Jabbing pain has resolved but aches and pains in joints and muscles continue. Fogginess is getting better but not totally resolved. Smell is still not accurate, things smell worse than they do for others. Nausea has resolved. Appetite is ok but gets full very quickly more than before. Hasn?t felt up to even calling to report her symptoms until today (03.30.21). On January 20, 2020; she thinks she may have had COVID. Was sick at that time just like she is now. Was tested for Flu A at that time and was Negative. Took her 1 month before she got better.
75 2021-03-30 confusional state c/o increased confusion, lethargy, weakness, urinary incontinence
75 2021-03-31 feeling abnormal Starved; Loss of her voice; Malaise; Epigastric stomach pain; Lost of appetite; Shortness of breath;... Read more
Starved; Loss of her voice; Malaise; Epigastric stomach pain; Lost of appetite; Shortness of breath; bad brain fog that comes and goes; lightheaded; headache; fatigue; chills; Weakness; Loss of taste; Indigestion; A spontaneous report was received from a other health professional concerning a 75-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, sick as heck with many problems/vaccination complication, being starved due to dietary restriction/medical diet, fatigue, malaise, weakness/asthenia, bad brain fog that comes and goes/feeling abnormal, chills but no fever/chills, loss of taste/ageusia, shortness of breath/dyspnea, lightheaded/dizziness, exhaustion/malaise, major indigestion/dyspepsia, stomach weakness and occasional epigastric stomach pain/abdominal pain upper, loss of appetite/decreased appetite, major loss of her voice/aphonia, headache, heart issues/cardiac disorder and feeling poorly/malaise. The patient's medical history as provided by the reporter included kidney problems, allergies. On FEB 2019, the patient fell extremely ill for three months having high fever, cough and green phlegm which got recovered in MAY 2019, from then the patient has a history of chills and voice issues. The patient got shingles vaccine on 28 DEC 2020. Concomitant medications included vitamins nos, synthroid, allegra, vlt c, colecalciferol and calcium citrate. On 12 FEB 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unspecified date in FEB 2021, after the mRNA-1273 vaccine injection, the patient experienced the events of fatigue, malaise, weakness, bad brain fog that comes and goes, chills but no fever, loss of taste, shortness of breath, unpredictable dizziness , lightheaded , exhaustion, four days of major indigestion, stomach weakness and occasional epigastric stomach pain, loss of appetite, dietary control, major loss of her voice, headache, heart issues and feeling poorly. The patient was on a strict diet because of her kidney problems and allergies (many allergies). The patient had heart issues that have not been able to be detected by the cardiologists she has seen. No treatment detail was provided. Action taken with mRNA-1273 in response to the events was not reported. The event s, fatigue, malaise, weakness, bad brain fog that comes and goes, chills but no fever, loss of taste, shortness of breath, lightheaded , exhaustion, four days of major indigestion stomach weakness, occasional epigastric stomach pain, loss of appetite, dietary control, major loss of her voice, headache, and feeling poorly 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. The patient's medical history of kidney problems, strict diet because of kidney problems, previous illness of 3 months causing voice issues and chills, remain as contributing factors.
75 2021-03-31 feeling abnormal 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 feeling abnormal Following first dose, only experienced fatigue and slight headache for one and a half days. Followin... Read more
Following first dose, only experienced fatigue and slight headache for one and a half days. Following second dose I experienced painful injection site for 2 days along with fatigue and generalized "out of sorts" for 2 days then felt quite well enough to resume normal activities and even took a 40 minute walk. That night (3/20) I had serious night sweats (fever?) and the following morning my arm at the injection site was hot and swollen and splotchy red, my face was swollen on the left side (side of injection, and my left temple was extremely painful to touch. I had a slight fever (100.5) and experienced a period of horrible chills. Later in the day my left eye became swollen and the area above my ear and eye and about one third of my forehead were bright angry red although the sensitivity of the temple had lessened. It was a Sunday and there was no walk-in clinic available so I contacted a Zoom style doctor through insurance. She advised she believed it to be an allergic reaction and that I should go to an emergency room. I wasn't experiencing any breathing issues and was no longer feeling feverish and chills so decided to wait and see what the morning would bring. Monday am the redness and swelling had spread to the right side of my face and the areas behind both ears and down my neck so decided I should be seen. I had already come to believe these were swollen lymph nodes and the Physicians Assistant I was able to see diagnosed as lymphadenopathy. The swellings and pain receded over the next few days. I still (4/1) have some stiffness in my left jaw and slight redness around my right eye above my ear.
75 2021-04-01 memory impairment 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 2021-04-03 sensation of foreign body No treatment yet, Symptons are funny feeling in throat on the right side, unable to clear throat, he... Read more
No treatment yet, Symptons are funny feeling in throat on the right side, unable to clear throat, heavy feeling on right between breast and shoulder, very lite head-ache,/ I just want to know if I should be worried!!
75 2021-04-04 depression Pain in arm, redness, rash, dizziness, sudden depression.
75 2021-04-04 feeling abnormal No effects after first dose other than achy shoulder the day of my first and second dose, but day af... Read more
No effects after first dose other than achy shoulder the day of my first and second dose, but day after second dose was awful. I had brain fog, fever, exhaustion all day, no appetite, couldn't get out of bed until late that evening. Pretty much slept the day away. Much better the next day.
75 2021-04-04 sleep disorder 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 2021-04-05 confusional state 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 memory impairment 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 2021-04-06 depression 3/30/21 Extreme backache, knee pain; 3/31/21 headache, aching behind eyes, and temperature 100 deg.,... Read more
3/30/21 Extreme backache, knee pain; 3/31/21 headache, aching behind eyes, and temperature 100 deg., tiny bit of left arm soreness, tiredness; 4/1/21 RIGHT arm soreness (the LEFT arm had been injected), headache, aching behind eyes, tiredness; 4/2/21 BAD left jaw pain, headache, tiredness; 4/3/21 headache, tiredness, general muscle pain; 4/4/21 tiredness, general muscle pain, fever blister on lip, canker sore in mouth (both at same time and had not experienced in several years); 4/5/21 very sore throat, fever blister and canker sore; 4/6/21 headache, fever blister, canker sore, sore throat; 4/7/21 (tomorrow) I still expect to have a headache and pain from the mouth sores. NOTE: only previous extreme backache and knee ache was experienced at age 16 before diagnosis with rheumatic fever; have experienced fever blisters and canker sores most of my life, except for last 10 years, these have been an unusual occurrence, nothing I did precipitated it.; left jaw ache experienced 20 years ago before diagnosis of Temporo-Mandibular Joint Dysfunction, this was also an unusual occurrence; I haven't had a sore throat in over 35 years. I FEEL THESE REACTIONS MANIFESTED MOSTLY FROM OLD MEDICAL EXPERIENCES. But the adverse effects just keep continuing. I am still suffering side effects almost a week after the second shot. It has been a VERY DEPRESSING experience.
75 2021-04-07 feeling abnormal, excessive sleepiness, mental impairment I had intense brain fog and it is hard for me to remember specific symptoms, but here is what I reme... Read more
I had intense brain fog and it is hard for me to remember specific symptoms, but here is what I remember. Chills for about an hour. Fever of 101.8 all 3/19 and most of 3/20. Couldn't think of what to eat, so didn't eat for 36 hours (I was using an intermittent fasting timer), thought about calling someone, but couldn't figure out how to use the phone or what I would say. Slept much of the day and have no memory of anything else. Felt a little better 3/21 & 3/22. Heavy brain fog lifted about 4:00 p.m. on 4/23.
75 2021-04-08 altered state of consciousness 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 2021-04-09 anxiety, crying Double vision of left eye. Totally exhausted, no energy. SOB, anxious & crying. Hoarseness, no ap... Read more
Double vision of left eye. Totally exhausted, no energy. SOB, anxious & crying. Hoarseness, no appetite, hot flashes & nite sweats. Bloodwork, ultrasound of thyroid, diagnosis: Hyperthyroidism, Graves Disease. No family history of thyroid disease. Presently under care of an endocrinologist.
75 2021-04-09 feeling abnormal #1Dose: Developed Covid arm 7 days post vaccine. Profound weakness. #2 dose: Second day post vaccin... Read more
#1Dose: Developed Covid arm 7 days post vaccine. Profound weakness. #2 dose: Second day post vaccine. Covid arm Elevated temp slight nausea coughing sneezing runny nose loss appetite metallic taste in mouth lymph node swelling, neck/armpit upper extremity weakness Brain fog Current: Profound fatique continues Fingernails splitting, thin. Hair has become limp and losing more than usual
75 2021-04-12 confusional state 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 feeling abnormal 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 2021-04-15 loss of personal independence in daily activities I woke up the next morning with sore muscles and a low fever felt increasingly ill through the day. ... Read more
I woke up the next morning with sore muscles and a low fever felt increasingly ill through the day. By noon I couldn't complete a sentence or understand what was being said to me. By the evening of 3/25/2021, I felt like I had the flu. It lasted a week. The second week I was very tired, not hungry. It another week before I had the stamina to do any chore for more than twenty minutes. The most common comment from family and friends was it sounded like I had the virus itself. (covid-19.
75 2021-04-18 anxiety At 4:40 AM the morning after the first vaccination shot, patient experienced the onslaught of the fi... Read more
At 4:40 AM the morning after the first vaccination shot, patient experienced the onslaught of the first of three epileptic seizures that day. Two more occurrences happened at 8:30 AM and 10:00 AM. At the beginning of each event I (husband & caregiver) administered prescribed prn 'breakthrough' medication to forestall a gran mal. After each administration of medication, patients symptoms subsided and she slept. Also it should be noted: she experienced anxiety about two hours after the vaccination shot on 3/11/2021. We were near the vaccination site, away from home. She self-administered a pain management pill at that point and the symptoms disappeared. Sometimes anxiety episodes evolve into seizures.
75 2021-04-18 sleep disorder I became ill as though I had an unusual flu which lasted for 1 1/2 days. Around 12 AM, my arm felt a... Read more
I became ill as though I had an unusual flu which lasted for 1 1/2 days. Around 12 AM, my arm felt achy, and a sensation went from my arm across my chest. I began to have joint pain and extreme chills and was shaking slightly. I could not sleep soundly and got up 3 times to urinate. I got up at 6 AM and was still very cold and too weak to stay awake. I wrapped up in a winter comforter and slept until 12 noon when I woke up soaked in sweat. The chills and pain were gone. I showered and ate a light meal. I went back to sleep and woke up several hours later again wet with sweat. I showered again, but I was still very tired. I went back to sleep until about 12 noon on Saturday when it passed.
75 2021-04-19 anxiety 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 mental status changes 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 2021-04-21 mental status changes 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 2021-04-23 feeling abnormal Found dead; Felt crappy; Wasn't feeling well; This spontaneous case was reported by a health care pr... Read more
Found dead; Felt crappy; Wasn't feeling well; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Found dead) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure abnormal ("Patient was on blood pressure medications for the last 20 years") and Anticoagulant therapy ("Patient started on a blood thinner in January 2021"). On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-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 FEELING ABNORMAL (Felt crappy) and MALAISE (Wasn't feeling well). On 18-Apr-2021, FEELING ABNORMAL (Felt crappy) and MALAISE (Wasn't feeling well) outcome was unknown. The patient died on 18-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided 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. The patient was on blood pressure medications (unspecified) for the last 20 years. She was started on blood thinner (unspecified) in January 2021. Treatment information leading up to the patient's death was not reported. Action taken with mRNA-1273 in response to the events was not applicable. A case of death of a 75-year-old, female patient 3 days after the second dose of mRNA-1273 (Lot # 040A21A). Patient had developed abnormal feeling and malaise 2 days after vaccine use and based on temporal association cannot be excluded. However, causality cannot be established for the death as cause of death is unknown. Further information is being requested.; Sender's Comments: A case of death of a 75-year-old, female patient 3 days after the second dose of mRNA-1273 (Lot # 040A21A). Patient had developed abnormal feeling and malaise 2 days after vaccine use and based on temporal association cannot be excluded. However, causality cannot be established for the death as cause of death is unknown. Further information is being requested.; Reported Cause(s) of Death: Found dead
75 2021-04-27 confusional state Dizziness, confusion, spasm, possible seizures.
75 2021-04-29 excessive sleepiness, feeling abnormal About 4 1/2 weeks after my second covid vaccine I turned over in bed and felt a wave of nausea sweep... Read more
About 4 1/2 weeks after my second covid vaccine I turned over in bed and felt a wave of nausea sweep over me, the room was spinning, I broke out in a sweat and at the same time saw flashing jagged streaks of light (with my eyes closed). I freaked out and wondered if I was dying or having a stroke or what. After lying in bed for awhile I was able to get up and get to the couch in the living room. The room was spinning continuously. I vomitted twice after I tried the Epley maneuver which I read about on line. I basically laid on the couch for a couple of days with my eyes closed. It helped to wear a neck collar which immobilized my head and I did try taking some Meclizine which both might have helped some - not sure. I spent most of the week resting and sleeping in a semi sitting position. Eventually the vertigo gradually improved but I still feel light headed and dizzy at times. Had one more severe episode when I sat up suddenly from sleep. This has been so scary and I'm so glad to hear other people are having the same problem because I was thinking I had a brain tumor or something. I have an appointment to get the ear wax removed by a professional after reading that pressure from wax against the eardrum might cause vertigo. If this doesn't help I will make an appointment with a doctor although it sounds like they probably don't have an answer. I just want to feel normal again. I am 75 years old and usually very healthy and on no meds.
75 2021-04-30 emotional distress Heavy limbs, shaking, chills, muscles "seized up", felt catatonic, fever 100.8, shooting pains in bo... Read more
Heavy limbs, shaking, chills, muscles "seized up", felt catatonic, fever 100.8, shooting pains in body, no appetite. Very tired, crabby, bad breath & taste , bad body odor. This lasted several days, but headaches, sore muscles, difficulty in breathing , vertigo lasted til end of next week. Headaches, fatigue, irritability & bad moods, inability to exercise (I usually do) lasted went until 3rd week of March before began to taper off.
75 2021-04-30 insomnia 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 2021-05-08 memory impairment, disturbance in attention Chills, headache, stomach ache, pain in calves, no energy Just out of it. No appetite, Lasted from ... Read more
Chills, headache, stomach ache, pain in calves, no energy Just out of it. No appetite, Lasted from Monday til Thursday. Had to work during this. Loss of concentration & forgetful.
75 2021-05-09 delirium, loss of personal independence in daily activities, feeling abnormal 3 days of 103.1 fever (12 hour delirium) during which I chipped several front teeth. 1 day of extrem... Read more
3 days of 103.1 fever (12 hour delirium) during which I chipped several front teeth. 1 day of extreme muscle and joint pain on 04/18/2021. This given in deltoid, but first shot still 2 inch diameter redness and soreness for almost 2 months given in biceps brachii. Strong headache for 2 weeks after 2nd shot, followed by moderate headache for 2 more weeks. Exhaustion and fatigue for 6 weeks after shot. Nausea began the day after the shot and increased, to the point where I am getting an upper GI 05/12/2021. Mind fog not tracking starting 2 days after shot and continuing beyond normal for 6 weeks. Was unable to drive for 2 weeks. Did report this to facility and to my primary, and tried to report at VAERS bout could not get through and form would not accept my age as fact but said your calculations "Differed". Timed out several times.
75 2021-05-09 feeling abnormal Numbness on the left side of their body, especially in the face, toes and fingers (feels like applin... Read more
Numbness on the left side of their body, especially in the face, toes and fingers (feels like appling Novocaine); Tingling on the left side of their body, especially in the face, toes and fingers; Knee pain; Body aching; Chills; Pain is so bad in arthritis areas/Shooting pain from the knees; By night she is a mess; She couldn't move; Freezing cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Numbness on the left side of their body, especially in the face, toes and fingers (feels like appling Novocaine)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes and Arthritis. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (Body aching). In March 2021, the patient experienced PAIN (Pain is so bad in arthritis areas/Shooting pain from the knees), FEELING ABNORMAL (By night she is a mess), HYPOKINESIA (She couldn't move), FEELING COLD (Freezing cold) and CHILLS (Chills). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness on the left side of their body, especially in the face, toes and fingers (feels like appling Novocaine)) (seriousness criterion hospitalization), PARAESTHESIA (Tingling on the left side of their body, especially in the face, toes and fingers) and ARTHRALGIA (Knee pain). The patient was hospitalized from sometime in April 2021 to sometime in April 2021 due to HYPOAESTHESIA. At the time of the report, HYPOAESTHESIA (Numbness on the left side of their body, especially in the face, toes and fingers (feels like appling Novocaine)), PAIN (Pain is so bad in arthritis areas/Shooting pain from the knees), PARAESTHESIA (Tingling on the left side of their body, especially in the face, toes and fingers), FEELING ABNORMAL (By night she is a mess), HYPOKINESIA (She couldn't move), FEELING COLD (Freezing cold), MYALGIA (Body aching), CHILLS (Chills) and ARTHRALGIA (Knee pain) 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, Computerised tomogram head: normal (normal) normal. On an unknown date, Computerised tomogram neck: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal. On an unknown date, X-ray: normal (normal) normal. Concomitant medications reported were diabetes medications. Treatment details included acetaminophen and ibuprofen. 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. Prior medical history of diabetes and arthritis may have been contributory for the occurrence of the events. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional information received included reporter details, laboratory investigations, suspect product details, new adverse events, seriousness criteria and treatment medication details.
75 2021-05-10 feeling abnormal, sleep disorder Neuropathy; Sweating; barely can walk; Fogginess in her mind; sleep problems; canceled appointment f... Read more
Neuropathy; Sweating; barely can walk; Fogginess in her mind; sleep problems; canceled appointment for second shot even though her HCP advised her to get it; Chilis; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 75-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. No Medical History information was reported. On 16-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 NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating), GAIT DISTURBANCE (barely can walk), FEELING ABNORMAL (Fogginess in her mind), SLEEP DISORDER (sleep problems), INTENTIONAL PRODUCT USE ISSUE (canceled appointment for second shot even though her HCP advised her to get it) and CHILLS (Chilis). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), HYPERHIDROSIS (Sweating), GAIT DISTURBANCE (barely can walk), FEELING ABNORMAL (Fogginess in her mind) and CHILLS (Chilis) had not resolved, SLEEP DISORDER (sleep problems) was resolving and INTENTIONAL PRODUCT USE ISSUE (canceled appointment for second shot even though her HCP advised her to get it) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No relevant concomitant medications were provided. No treatment information was provided. This case of a 75-year-old female patient who canceled appointment for second (Intentional deviation from dosage regimen) due to events experienced following the first dose of mRNA-1273. The event of Intentional deviation from dosage regimen is assessed as not applicable. Based on temporality and excluding other etiologies, the causal relationship between the other events and the product use cannot be excluded. Chills is consistent with the product known safety profile. This case was linked (E2B Linked Report).; Sender's Comments: This case of a 75-year-old female patient who canceled appointment for second (Intentional deviation from dosage regimen) due to events experienced following the first dose of mRNA-1273. The event of Intentional deviation from dosage regimen is assessed as not applicable. Based on temporality and excluding other etiologies, the causal relationship between the other events and the product use cannot be excluded. Chills is consistent with the product known safety profile.
75 2021-05-10 mental status changes Admitted to the hospital 3/9 with altered mental status,patient is complaining of generalized myalgi... Read more
Admitted to the hospital 3/9 with altered mental status,patient is complaining of generalized myalgia, especially in legs and lower back. Continues to have chills, mild nausea and endorses possible 1-2 episode of diarrhea.IV fluids, tylenol, rocephin, potassium. From Discharge summary: year old female who was admitted on 3/9/2021 for ADVERSE EFFECT OF CORONAVIRUS COVID-19 VACCINE. Patient had a second dose of her covid vaccination and 12 hours later patient developed nausea, vomiting, diarrhea and myalgias and arthralgias with lactic acidosis. Patient's symptoms nearly resolved after 48 hours with residual diarrhea. Patient eating, ambulating, not on oxygen at all, pt also may have had some sepsis
75 2021-05-15 insomnia Very severe metallic taste. So severe I had a hard time getting to sleep that evening due to this ... Read more
Very severe metallic taste. So severe I had a hard time getting to sleep that evening due to this taste. It was less the next morning and continued to fade till gone in two-three days. Same thing happened with the first injection on 2/25/21, however, not as severe and I didn't equate it with the vaccine till it happened with the second dose. I blamed chemicals being added to my water at the time.
75 2021-05-17 confusional state 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 2021-05-19 feeling abnormal felt like she had mono
75 2021-05-25 restlessness, agitation, confusional state, hallucination Patient with a history of neurocognitive disorder brought in by paramedics from home with concern fo... Read more
Patient with a history of neurocognitive disorder brought in by paramedics from home with concern for increased agitation, restlessness, confusion, hallucinations. Temporal relationship to 2nd dose of Moderna vaccine approx 24 hrs prior to onset.
75 2021-05-27 feeling abnormal 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 2021-06-01 feeling abnormal 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 2021-06-02 excessive sleepiness Severe fatigue sleeping 20+ hours, nausea, headaches
75 2021-06-03 confusional state, feeling abnormal Tied & in bed by 6pm that same evening. Second day concussion, third day, throwing up, not feeling w... Read more
Tied & in bed by 6pm that same evening. Second day concussion, third day, throwing up, not feeling well at all. Called on call nurse twice in this 3 day period & they said to go to ER within an hour. She had an underlying UTI hospital said & her body was working ?overtime? with vaccine & UTI. Still was sick for another 2-3 weeks. Took to dr several times to check. Second vaccine - tired, body aches. Has slept much, much more since vaccine. Seems confused & just not THE SAME! Went to hospital 6/3/21 by ambulance because she wasn?t feeling well - throwing up yellow bile, extremely clammy (sweating), confused, bp when ambulance got to her, 89/60. ER can every test - urine, blood, cat scan, stroke, heart attack. NOTHING. Came back all normal. A mystery. This is 5 months since first vaccine.
75 2021-06-07 feeling abnormal, hallucination feet and legs started swelling up; face swelling; eyelid swelling; fatigue; fever; a little headache... Read more
feet and legs started swelling up; face swelling; eyelid swelling; fatigue; fever; a little headache; feeling like car is driving while not doing anything; feeling hot; hallucinating; This spontaneous case was reported by a patient and describes the occurrence of HALLUCINATION (hallucinating) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension and Chronic kidney disease stage 4 (stage 4 kidney disease). On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), FEELING HOT (feeling hot), FEELING ABNORMAL (feeling like car is driving while not doing anything), HEADACHE (a little headache) and PYREXIA (fever). On 28-May-2021, the patient experienced PERIPHERAL SWELLING (feet and legs started swelling up), SWELLING FACE (face swelling), SWELLING OF EYELID (eyelid swelling) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HALLUCINATION (hallucinating), PERIPHERAL SWELLING (feet and legs started swelling up), FEELING HOT (feeling hot), SWELLING FACE (face swelling), FEELING ABNORMAL (feeling like car is driving while not doing anything), SWELLING OF EYELID (eyelid swelling), HEADACHE (a little headache), FATIGUE (fatigue) and PYREXIA (fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Blood pressure measurement: 191/90 mmHg (High) 191/90. On 27-May-2021, Heart rate: high (High) rapid heart rate. On 28-May-2021, Blood pressure measurement: 187/87 mmHg (High) 187/87. 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's symptoms started about 45-mins after getting the first dose. These symptoms were a little headache, feeling like car was driving while not doing anything, wondering why the next car was moving, felt like hallucinating, rapid heart rate, getting fever and hot. It was cold, but felt hot.Needed to call a friend to help stay alert while driving home from the vaccination facility. A blood pressure (BP) of 191/90 on 27-May-2021 and BP was still high at 187/87 on 28-May-2021. On the morning of 28-May-2021, feet and legs started swelling up and the patient could not see the TV because of face and eyelid swelling, and fatigue. 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.
75 2021-06-07 excessive sleepiness Mild headache on first evening, followed by muscle aches, nausea, pain at injection site, sleepiness... Read more
Mild headache on first evening, followed by muscle aches, nausea, pain at injection site, sleepiness and fatigue, possible fever, chills. Patient did not vomit but slept for two days, waking intermittently. Pain at injection site gone on 5th day. No treatment. Full resolution by 5th day.
75 2021-06-08 insomnia, sleep disorder She got her vaccine, she was fine, did her normal activities. Last night in the late afternoon she... Read more
She got her vaccine, she was fine, did her normal activities. Last night in the late afternoon she had a sore throat, scratchy throat. Around midnight she woke up with a lot of mucus and was expectorating it, and was up a lot during the night. She took an allergy pill, cough drops and some cough medicine, and doesn't know if it's the vaccine or change in weather. Today she is much better, a little weak from lack of sleep. She still feels somewhat congested.
75 2021-06-09 confusional state, amnesia feverish red arm, extreme pain, confusion, loss of memory, sleepy,
75 2021-06-10 feeling abnormal I got up from bed walking to bathroom about 2 feet away. Just before I got to door, I lost control... Read more
I got up from bed walking to bathroom about 2 feet away. Just before I got to door, I lost control of my body and I fell into a wall I couldn't lift my legs or head up. The door to the bathroom was 18 inches away. I pushed my body to the door and sat on the toilet. The room was spinning around and around. My husband helped dragged me to my bed because I couldn't walk. Then my spinning stopped and then I felt better. About an hour and a half later I went to the ER and they wanted to determine if I had experienced a stroke in which I didn't. A couple weeks later I was sent to a neurologist and they couldn't figure out what it was either. I have been off balanced and motion makes me feel a little dizzy when driving in the car and turning corners. I had gotten better until about a week ago and then it started back. I felt a fullness and a sense of not feeling well and then the exact thing came back. My sinuses started feeling full. I felt like I had a cold. The spray for sinuses doesn't work at all like they used to for me. I'm worse when I get up in the morning. When I am lying down I feel fine except for stuffy nose. My throat has been sore for about 3-7 days and my ears felt full. I also had a bad headache for days from the back and the front.
75 2021-06-13 anxiety Patient has a history of chronic panic attack . Present with signs and symptoms of anxiety. Patient... Read more
Patient has a history of chronic panic attack . Present with signs and symptoms of anxiety. Patient reports feeling light headedness and dizziness after vaccine. Vitals all in normal limits . After being asked patient reports feeling better. Patient walk.
75 2021-06-14 feeling abnormal rheumatoid arthritis she had a flare; run over by a truck; became stiff and hurt all over; jaw hurt;... Read more
rheumatoid arthritis she had a flare; run over by a truck; became stiff and hurt all over; jaw hurt; headache; hurt all over/ achy feeling; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 029L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatoid arthritis. On 15-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 16-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) (seriousness criterion medically significant), FEELING ABNORMAL (run over by a truck), MUSCULOSKELETAL STIFFNESS (became stiff and hurt all over), PAIN IN JAW (jaw hurt), HEADACHE (headache) and MYALGIA (hurt all over/ achy feeling). The patient was treated with Physical therapy for Rheumatoid arthritis; Physical therapy for Feeling abnormal; Physical therapy for Musculoskeletal stiffness; Physical therapy for Pain in jaw; Physical therapy for Headache and Physical therapy for Myalgia. On 17-Mar-2021, PAIN IN JAW (jaw hurt) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis she had a flare) had not resolved and FEELING ABNORMAL (run over by a truck), MUSCULOSKELETAL STIFFNESS (became stiff and hurt all over), HEADACHE (headache) and MYALGIA (hurt all over/ achy feeling) outcome was unknown. No relevant concomitant medications were reported. The patient stated how long this flare up would last and should she continue to go to physical therapy. 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 US-MODERNATX, INC.-MOD-2021-048039 (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.
75 2021-06-17 sleep disorder Right after the injection, my left arm was hot to the touch, sore at injection site, no discoloratio... Read more
Right after the injection, my left arm was hot to the touch, sore at injection site, no discoloration except redness, low grade fever and chills in the evening. These symptoms got progressively worse and my arm became swollen and hard. When I turn over at night in my sleep, the pain was so extreme, I would wake up. My "covid arm" symptoms lasted about 10-14 days and slowly went away. I did take Tylenol for the pain. I had an annual appointment scheduled with my doctor so I got him to look at my arm. He was not concern about it.
75 2021-06-26 feeling abnormal Brain fog, unsteadiness, disequilibrium, eyelids feel heavy, numbness in fingertips, left hand
75 2021-06-29 sleep disorder Itch, hives, rash on legs and all over body. Went to walk in clinic , also had rash on left leg, Dr... Read more
Itch, hives, rash on legs and all over body. Went to walk in clinic , also had rash on left leg, Dr said looked liked cellulitis. Trouble swallowing, could not sleep due to itching and hives . Hard lumps with the itching rash
75 2021-07-06 emotional distress, anxiety 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 2021-07-11 loss of personal independence in daily activities July 3 -I was completely bedridden , weak, and nauseous, -I had a piercing headache --I took migrai... Read more
July 3 -I was completely bedridden , weak, and nauseous, -I had a piercing headache --I took migraine medication which did not help and ibuprophen for pain- July 4, I was better and able to function, headache went away in the morning-- , July 5th I was so tired I could not get up or do anything and had piercing headache took ibuprophen- -July 6th I was too tired to do anything and had piercing headache took ibuprofen-- July 6 - 11 I was better but very tired and still had headache took ibuprofen every day-- Today I am better and the headache is much less but I am very tired all the time.
75 2021-07-12 poor quality sleep 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 2021-07-17 disorientation hospitalized due to withdrawal symptoms from these two medications; 2nd dose was given 3.5 months fr... Read more
hospitalized due to withdrawal symptoms from these two medications; 2nd dose was given 3.5 months from the first dose; Headache; Ringing in the ears; Disorientation; This spontaneous case was reported by a consumer and describes the occurrence of WITHDRAWAL SYNDROME (hospitalized due to withdrawal symptoms from these two medications) in a 75-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. No Medical History information was reported. On 18-Mar-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 18-Mar-2021, the patient experienced WITHDRAWAL SYNDROME (hospitalized due to withdrawal symptoms from these two medications) (seriousness criterion hospitalization). On 24-Mar-2021, the patient experienced TINNITUS (Ringing in the ears), DISORIENTATION (Disorientation) and HEADACHE (Headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose was given 3.5 months from the first dose). The patient was hospitalized on 18-Mar-2021 due to WITHDRAWAL SYNDROME. The patient was treated with ROPINIROLE at an unspecified dose and frequency and ZOLPIDEM TARTRATE (AMBIEN) at an unspecified dose and frequency. At the time of the report, WITHDRAWAL SYNDROME (hospitalized due to withdrawal symptoms from these two medications), TINNITUS (Ringing in the ears), DISORIENTATION (Disorientation) and HEADACHE (Headache) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (2nd dose was given 3.5 months from the first dose) had resolved. No concomitant medications were reported. On an unknown date, the patient called to inquire if should start the series of Moderna COVID-19 vaccine or should take 2nd dose even if it had been 3.5 months from first dose. At the time of first dose the patient was coming off of two heavy medications Ropinirole and Ambien and was hospitalized due to the withdrawal symptoms. The patient was experiencing terrible withdrawal symptoms. At first patient thought it was all from the vaccine but later was hospitalized due to withdrawal symptoms from these two medications. Because of this reason missed the 2nd dose within the recommended dosing interval. Tried reaching out to medical facilities around the area and they informed that patient needed to start the series all over again. The patient went to the pharmacy on 11-Jul-2021, mentioned to Pharmacist what other facilities had informed about starting the series over. However, the pharmacist said that patient could only take one more dose since already had one dose. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. For the event Drug withdrawal syndrome, there are other confounders/do-suspects. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Patient details, therapy details, new events and treatment drugs were 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. For the event Drug withdrawal syndrome, there are other confounders/do-suspects. Further information has been requested.
75 2021-07-21 loss of personal independence in daily activities, sleep disorder Adverse effects began day after first shot. Both hands stiff, sore and hot. Right shoulder was imm... Read more
Adverse effects began day after first shot. Both hands stiff, sore and hot. Right shoulder was immobile. Right side more effected than left. Pain became increasingly worse and debilitating. Unable to complete common tasks easily such as brush teeth and feed myself. Took 2 months to get into primary doctor. Ordered blood draw. First tried Diclofenic and Tizanidine. Pain continued to progress. Refereed to specialist in Rheumatology. Re conducted blood draw. Diagnosed with Rheumatoid Arthritis. Prescribed Prednisone, Folic Acid, Methotrexate, Hydroxychloroquine, Alendronate, Able to move about more freely on medication. Able to sleep again