Moderna

Psychological symptom reports

Male, 60 - 75 years

Age Reported Symptoms Notes
60 2021-01-04 mental status changes Shoulder/arm pain; change in LOC; Labs pending
60 2021-01-08 confusional state Confusion, Headache, Myalgia, Fever, soreness at injection site starting after 12 hours, fatigue, la... Read more
Confusion, Headache, Myalgia, Fever, soreness at injection site starting after 12 hours, fatigue, lack of appetite, temp of 104.3 Narrative: employee was told to follow up with his physician and get tested for covid
60 2021-01-20 impaired work ability Temp 100.7 F, chills, generalized body aches, and excess fatigue. Onset of symptoms occurred in t... Read more
Temp 100.7 F, chills, generalized body aches, and excess fatigue. Onset of symptoms occurred in the early morning hours the day after receiving the vaccine. Symptoms completely resolved by the next morning. Treatment was conservative with Tylenol, rest, and hydration. I missed one day of work due to this brief episode. I am a SARS COVID survivor who had a very severe / life threatening case of SARS COVID 19. I was hospitalized and treated from March 28, 2020 to May 16, 2020. Please feel free to contact me for any information that you may need.
60 2021-01-21 confusional state confused, hypertensive, very pale and sweaty 6 minutes after receiving vaccine.
60 2021-01-21 feeling abnormal Pain in wrist immediately after injection blurry vision an hour and half after injection brain fog, ... Read more
Pain in wrist immediately after injection blurry vision an hour and half after injection brain fog, flushed face, feeling of swollen face, shortness of breath about throughout the night and into the next morning along with elevated blood pressure.
60 2021-01-22 insomnia Mild fatigue, general aches & pains, very sore shoulder at injection site, chills, difficulty sleepi... Read more
Mild fatigue, general aches & pains, very sore shoulder at injection site, chills, difficulty sleeping due to muscle aches.
60 2021-01-22 insomnia Within two hours of injection, greater than normal injection site pain. Within six hours, diarrhea /... Read more
Within two hours of injection, greater than normal injection site pain. Within six hours, diarrhea / mild nausea (no vomiting). Insomnia that night accompanying whole-body aches/pains/malaise. Pain most notable in extremities. Nausea more significant at 12 hours (i.e. 6AM) but no vomiting. Significant lethargy all day 1/22/2021. Pain/nausea gone by 6PM but lethargy remained. Slept most of the day. Symptoms gone by following morning (1/23/2021), so roughly 36 hours. Overall these were symptoms consistent with a really bad case of the flu, minus the respiratory symptoms. I often work through illnesses like the flu. Couldn?t work through this.
60 2021-01-24 impaired work ability Moderna COVID-19 Vaccine EUA Had chills during night. Took Naproxen with some relief. 12N had uncont... Read more
Moderna COVID-19 Vaccine EUA Had chills during night. Took Naproxen with some relief. 12N had uncontrolted shaking and chills and malaise, unable to handle mouse to do work. No redness, swelling or irritation of injection site. Extremely tired.
60 2021-01-28 restlessness C/0 feeling "hot flashes" an hour after vaccination given. As the evening progressed C/O joint ach... Read more
C/0 feeling "hot flashes" an hour after vaccination given. As the evening progressed C/O joint aches, HA, low grade temp (99.8 F at 6 p.m., muscle cramps and restlessness during the night (2 a.m.) and feeling of "electrical shocks" in his muscles. 1/27/21- C/O joint pain HA and muscle cramps-took gabapentin and Tylenol and feeling better. 1/28/21 Able to work, feeling better, but not 100% yet.
60 2021-02-01 impaired work ability On 1/14/2021 ( about 14 days from dose # 1) Tachycardia of unknown origin, 120 BPM for 6 hours, Call... Read more
On 1/14/2021 ( about 14 days from dose # 1) Tachycardia of unknown origin, 120 BPM for 6 hours, Called Cardiologist and was seen @ MD next business day, and given EKG and Bystolic 10 MG to "add" to daily regimin IF it returned. It retuned to normal after 6 hours, and then occurred again 1 week later...for 6 hours. I took Bystolic, and about 8 hours later it returned to baseline (about 62/min. on Sun 1/24/2021, I woke up to bloody diarrhea x several episodes...this continued until Wed 27th, at which time my son (a 4th year graduating MD student) drove me to hospital and I was seen in ER room by MD. I was admitted, and had emergency surgery 1/27/2021 straight from Er Room. I had life saving surgery the next day to stop a lower GI bleed (of unknown origin). I was discharged 3 days later, and I am awaiting more testes, appts, etc.... I have lost time, money, and work from this near death experience... and the tachycardia still needs to be followed up on . I am EXTREMELY upset by these events, as I almost died....was hospitalized, incurred a lot of expense, used up all my sick pay and personal days, and out-of -pocket to my healthcare insurer.
60 2021-02-06 impaired work ability I woke up approximately 2am 2/5/2021 the night after receiving the vaccination 2/4/2021 (about 13 ho... Read more
I woke up approximately 2am 2/5/2021 the night after receiving the vaccination 2/4/2021 (about 13 hours afterwards) with severe chills, shoulder, knees & most joints aching badly, bones in both feet aching with any movements, both arms sore along with severe stomach cramps & nausea, these all lasted through the night and day with a fever of 101 at 7am but by 4pm all but the stomach cramps were replaced by just nausea but severe headache and weakness all over were felt. I remained in bed until about 4pm 2/5/21 & soaked in a hot bath which relieved the joint pains. Headache, nausea & weakness continued 2/6/2021 & 2/7/2021 with the headaches coming if any sudden movements such as coughing or standing up too fast & nausea irritated by eating anything but saltine crackers. Today is 2/7/2021, took sick days from work 2/5, 2/6 & 2/7.
60 2021-02-07 insomnia Arm was sore shortly after injection, then about 8 hours later chills, headache, nausea, body/joint ... Read more
Arm was sore shortly after injection, then about 8 hours later chills, headache, nausea, body/joint pain, fatigue, mild cough, temperature elevated but not high, about 99 degrees. Symptoms varied over about 24 hours then subsided. Injection was Friday morning, Friday night not much sleep due to symptoms, all day Saturday in bed, slept well Saturday night, and Sunday fatigue and achiness only.
60 2021-02-08 feeling abnormal Temporary paralysis of left eyelid which was a symptom of Bells Palsy. At the same time I experien... Read more
Temporary paralysis of left eyelid which was a symptom of Bells Palsy. At the same time I experienced a very disturbing sensation of having no saliva in mouth or throat. I was completely dry and unable to produce saliva. This is my description of the event: I woke up around 3am with rapid heartbeat, lightheadness, and upon opening my eyes I realized my left eyelid was drooping and I was unable to open it. At the same time I experienced extreme dryness in my mouth and throat where i had absolutely no moisture/saliva and was unable to produce any for approximately 20 minutes. I walked to an emergency, which was just 2 blocks away, to get checked out. I told the attending nurse and physician what my symptoms were. Luckily by the time I was admitted to the ER the symptoms began to dissipate. My eyelid was slightly droopy but moving and i was able to produce saliva again. I explained that I've never experienced symptoms like this before in my life and that I believed this was from the vaccine. I had been experiencing symptoms every day since receiving the shot.... from headaches, to fatigue, to tightness in my chest, a cough, pain in my larynx that towards my chest, pain in my upper left abdomen, strange sensations in my legs, brain fogginess, and some swollen lymph nodes.
60 2021-02-19 feeling abnormal The patient was given his vaccine at 11:40am and a few minutes later 11:43am he said he was feeling ... Read more
The patient was given his vaccine at 11:40am and a few minutes later 11:43am he said he was feeling very flushed and off. He said this extremities (hands and feet) felt hot and blotchy which is not normal for him (he does have neuropathy). He was sitting down for a couple minutes and I gave him water to drink just to calm down if it had been anxiety, but it did not seem to help. He started to complain of his heart pounding and beating rapidly. He said he was sweating and just felt very strange. I asked if he was short of breath at all which he denied. I immediately called 911 to have him be checked out and make sure he was ok since his symptoms had been going on for a few minutes, he was still complaining, and was not resolved with sitting or drinking a cold water. The patient did state that he had not eaten yet today (he does intermittent fasting and normally does not eat until 2pm), he did not take his blood pressure medication atenolol, and had driven about an hour here with his mother as she also got the vaccine today. While waiting for the ambulance I took his blood pressure which was very high 187/95mmHg which the patient confirmed is high for him. The ambulance arrived within 10 minutes and they checked him out. He did decline to go to the hospital after a thorough evaluation. The patient left once the paramedics cleared him at about 12:35pm so he was sitting and being monitored for a good 45 minutes before he left the store. The patient was never given any meds during this process and was cleared to go home by paramedics.
60 2021-02-21 sensation of foreign body Seen in ED,Patient will with reports of a globus sensation in his throat that started this afternoon... Read more
Seen in ED,Patient will with reports of a globus sensation in his throat that started this afternoon 2/18, Patient with some inflammation of the uvula with mild erythema.Concern for old allergic reaction versus uvulitis. Pt has no other associated symptoms. Patient was treated with oral Decadron however spit this out, was then treated with IM Decadron. No other symptons. At time of discharge pt was asymptomatic.
60 2021-02-23 poor quality sleep Chills, joint pain and slight pain in bones. went to bed at 10 PM with chills, at midnight severe sw... Read more
Chills, joint pain and slight pain in bones. went to bed at 10 PM with chills, at midnight severe sweating. 5 AM woke with pains in joints and bones. Took three Tylenol extra strength. Woke at 8 AM, took two more Tylenol. Currently at 10:30 AM feel OK, a little tired from lack of sleep. most symptoms gone.
60 2021-02-28 anxiety Swelling on right side of face occurred 24-48 hours after injection. Feelings of anxiety of unknown ... Read more
Swelling on right side of face occurred 24-48 hours after injection. Feelings of anxiety of unknown origins 24 hours after injection. Soreness at the injection site.
60 2021-03-08 impaired work ability Body aches, HA, Fever, unable to come in for next shift
60 2021-03-08 impaired work ability Evening after 2nd injection (Friday, March 6, 2021): severe, debilitating pain, specifically in the ... Read more
Evening after 2nd injection (Friday, March 6, 2021): severe, debilitating pain, specifically in the area of the heart. Went to ER and was given EKG, Chest X-Ray, and blood tests to check for heart attack. Symptoms subsided after a bit. Labs were inconclusive. Sent home. Continued to have lingering aching in the heart region the next day. Throughout the weekend, continued to experience alternating sweats and chills, nausea and increased pain in hip joints causing difficulty to walk. Stayed home from work on Monday, March 8, 2021 with the same symptoms continuing. Tuesday, March 9, 2021 began experiencing excruciating thigh and knee pain to the point of barely being able to stand or walk. Returned to the ER where they administered Torodol and pain subsided. Will be seeing primary care physician Tuesday afternoon.
60 2021-03-11 confusional state Muscle neck and right arm became very tight and knee joints hurt started at 8 pm one day after .. My... Read more
Muscle neck and right arm became very tight and knee joints hurt started at 8 pm one day after .. My wife systems much worse fever, breathing Nausea headache. this lasted for two days no energy confusion sweats
60 2021-03-11 sensation of foreign body 08:10 vaccine administered 08:14 dizzy, light headed, room spinning. Sat down 08:25 felt lump in t... Read more
08:10 vaccine administered 08:14 dizzy, light headed, room spinning. Sat down 08:25 felt lump in throat, contacted clinic nurse in waiting area. Uncomfortable but never to the point of difficulty breathing. ~08:30, BP 128/99 (I think) Systolic up only a bit. Diastolic very high for me sent to urgent care part of clinic. Monitored BP, oxygen, did EKG (normal), symptoms started easing ~ 09:40. Sent home. Attending PA though it might just be a Vaso-Vagel response, but, after hundreds upon hundred of needles, I've never had such a response, and, my symptoms did not involve a low BP, fainting or nausea, rather I remained conscious, had throat constriction with increased BP and a narrowed pulse pressure range.
60 2021-03-12 sleep disorder Injection was given very high up near shoulder. Experiencing pain in left shoulder and unable to ful... Read more
Injection was given very high up near shoulder. Experiencing pain in left shoulder and unable to fully extend my arm. Was not able to sleep first 2 nights with pain. Still not able to lift arm without pain in shoulder.
60 2021-03-13 impaired work ability Starting the morning after shot when I got up at 4.00am I was having reactions to the shot. Hot, Col... Read more
Starting the morning after shot when I got up at 4.00am I was having reactions to the shot. Hot, Cold, Headache , muscle pain, tired, nausea, loss of appetite like a bad case of flu. also which has been the biggest most unexpected side effect is that my left testicle was swollen and painful. All my flu like systems continued as well thru Wednesday 03/10/2021. started feeling some better except for being tired and the swelling and pain in testicle. Thursday morning went to Urgent Care, did examination with urinalysis and thought possible infection. Recommended ultrasound and prescribed Doxycycline HYC 100MG, also Ibuprofen 800mg.
60 2021-03-14 sleep disorder about ten hours after injection chills then fever then difficulty breathing sinuses draining couldn'... Read more
about ten hours after injection chills then fever then difficulty breathing sinuses draining couldn't slrrp took benadryl called 911 they came and took my vitals highblood pressure a fever of 101 it wasn't to bad so they left i stayed awake all night and started to feel better the next day
60 2021-03-16 amnesia Fever/ Chills/ Pain in my whole body/ Sicker than I was ever before in my life. Lose of Memory. Hea... Read more
Fever/ Chills/ Pain in my whole body/ Sicker than I was ever before in my life. Lose of Memory. Head Aches/ Leg pain that wasn't there before vaccination.
60 2021-03-17 amnesia, confusional state, mental status changes, abnormal behaviour pt presented to emergency department on 3/6/21 with change in mental status first noted at 10am; per... Read more
pt presented to emergency department on 3/6/21 with change in mental status first noted at 10am; per reports, his employees noticed he was not acting himself, and he went home to rest; ED notes indicate he reported a right sided headache and was confused and had difficulty with word finding, but did say, "I can't remember anything." Pt also had elevated BP in ED; he was able to follow some commands but continued to have difficulty forming words and hand squeeze noted to be weaker on the right side and he could not keep his right leg elevated; pt fell asleep during exams; patient's neice, who is an ED physician, reported that pt had become encephalopathic with severe DKA and AKI in the past; he was started on IVF and insulin drip and transferred from ED to ICU; he went into rapid atrial fibrillation and was then started on diltiazem drip; cardiology was consulted, adjusted medications, and anticoagulation was not recommended as the episode was transient; he started spiking fever with Tmax of 101; blood cultures were drawn and he was started empirically on ceftriaxone, vancomycin, and acyclovir; IR was consulted for LP with results showing WBC 123, RBC 41, 90% neutrophils, glucose 186, protein 100; he was seen by ID and noted that CSF profile was consistent with most likely an early viral infection
60 2021-03-19 excessive sleepiness 20 hours after vaccination, Pt began feeling unwell. He was tired, his body hurt, and he had the ch... Read more
20 hours after vaccination, Pt began feeling unwell. He was tired, his body hurt, and he had the chills. He came home from work, got into bed with a heated blanket (teeth chattering) and fell asleep. He woke a few times to urinate and drink water, but slept for 16 hours. He kicked off the heated blanket after 2 hours.
60 2021-03-21 confusional state, memory impairment On March 16th at roughly 1:30pm, the patient received his first dose of the COVID19 Moderna vaccine.... Read more
On March 16th at roughly 1:30pm, the patient received his first dose of the COVID19 Moderna vaccine. Afterward, the patient experienced no adverse side effects. About 48 hours later, however, at 2pm on March 18th, the patient's spouse attempted to wake him from a nap. The patient seemed much groggier than normal and his expression appeared vacant. When pressed by his spouse, the patient could not say who he was, or who his wife was. He agreed to travel with his wife to the hospital. At the hospital, a healthcare professional asked the patient who he was. He answered with his correct name. He also correctly identified his spouse by name. But when asked where he was, the patient gave a long and incoherent response. After this initial screening, doctors at the hospital evaluated the patient for a stroke. They ruled this out as a possibility. Next, they suspected the patient's MS lesions may have contributed to his "cognitive event." However, after comparing his 2018 scan to a current scan, they determined this was unlikely the cause. After about 24 hours at the hospital, a neurologist hypothesized that the patient had experienced a seizure. Another doctor at the facility concurred with this assessment. By late Friday (more than 24 hours after the episode), the patient had regained most of their cognitive functioning, though he still experienced mild confusion around the week's events (even preceding the "cognitive event"). Prior to now, the patient has never had a seizure before.
60 2021-03-23 memory impairment This may be purely coincidence, but the reaction was so severe, I thought you should have the puzzle... Read more
This may be purely coincidence, but the reaction was so severe, I thought you should have the puzzle piece. On March 23 I donated blood. Within 30 minutes I had a fever of 100.9, was extremely weak and sleepy, had the worst sore throat and radiating down in my memory. It was difficult to even speak. I have donated blood in decades and never had an adverse event.
60 2021-03-23 sleep disorder After the 2nd inj of Moderna, I?ve been experiencing a chronic pain on the injection site, now it?s ... Read more
After the 2nd inj of Moderna, I?ve been experiencing a chronic pain on the injection site, now it?s forming a lump exactly where the needle was placed, the pain is increasing and sensitive to touch the area of the injection, I?m unable to sleep on the left side of my body.. What should I do?
60 2021-03-23 sleep disorder Patient woke up in middle of night the following day after the vaccination with shaking, muscle weak... Read more
Patient woke up in middle of night the following day after the vaccination with shaking, muscle weakness, dizziness, severe muscle soreness, and inability to walk. Patient went to emergency room to rule out more serious complications. All tests came out normal and was told the symptoms were a reaction to the vaccine. The symptoms continued for 2 days, but eased up with time. Patient was feeling normal 5 to 6 days after administration.
60 2021-03-24 sleep disorder PATIENT EXPERIENCED EXACERBATION OF ASTHMA SYMPTOMS. HE NEEDED TO USE HIS INHALER MORE OFTEN, AND WA... Read more
PATIENT EXPERIENCED EXACERBATION OF ASTHMA SYMPTOMS. HE NEEDED TO USE HIS INHALER MORE OFTEN, AND WAS WOKEN UP FROM SLEEP WHEEZING (WHICH IS NOT NORMAL FOR HIM). HE WAS ABLE TO CONTROL HIS SYMPTOMS WITH HIS INHALER, AND HE STILL WANTS TO RECEIVE HIS SECOND DOSE.
60 2021-03-31 sleep disorder 3/30/21 - Vaccination administered 0645, minor soreness at injection site. 3/31/21 - Upon awakening... Read more
3/30/21 - Vaccination administered 0645, minor soreness at injection site. 3/31/21 - Upon awakening at 0600, minor soreness at injection site with additional minor pain in right trapezius muscle. Later, 400 p.m. feeling of minor weakness, 900 p.m. more noticeable pain (muscle soreness) in right trapezius. 4/1//2 - Awaken at 3:00 a.m. by more severe pain in right trapezius. Upon getting out of bed at 6:00 a.m. found pain expanded to full right trapezius, partial extension to middle of right pectoral, fully up right side of neck, and partially in right armpit. Right side of face experiencing numbness along right cheek bone and right side of right eye. Experiencing increased pain when raise right arm elbow above shoulder. Typing this is difficult.
60 2021-04-01 sensation of foreign body Globus; A spontaneous report was received from a Physician concerning a 60 years old, male patient w... Read more
Globus; A spontaneous report was received from a Physician concerning a 60 years old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced globus/Sensation of foreign body. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 006M20A) on 17 Feb 2021, approximately one day prior to the onset of the symptoms intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, the patient experienced an instance of globus. On 18 Feb 2021, the patient was taken to the emergency room and treated with dexamethasone via intramuscular route and was discharged from the emergency room. No relevant laboratory details were included. Action taken with the drug in response to the events were not reported. The outcome of the event, globus was recovered on 18 Feb 2021.; Reporter's Comments: Very limited information regarding the symptoms has been provided at this time. Further information has been requested.
60 2021-04-01 sleep disorder The evening of the shot, around 10pm, I noticed that I was getting chills. A hour or two later the ... Read more
The evening of the shot, around 10pm, I noticed that I was getting chills. A hour or two later the fever started. Sleep was difficult in bed because of pain in right arm. Fever and chills continued Saturday, with a high temperature of 101.5F, along with body aches and pain. Symptoms started to lessen on Sunday, chills first then fever, and finally disappeared on Sunday night. Pain at injection site lasted for a few more days.
60 2021-04-02 excessive sleepiness He has been sleeping all day and at 1:30 pm he has started throwing up and has a fever of 100.9. Thi... Read more
He has been sleeping all day and at 1:30 pm he has started throwing up and has a fever of 100.9. This is less than 24 hours after receiving his first dose of his vaccine.
60 2021-04-07 excessive sleepiness Received my second shot 4/7/21 at 10:30am woke up 6:30am 4/8/21 fever, chills, sweats achy and tired... Read more
Received my second shot 4/7/21 at 10:30am woke up 6:30am 4/8/21 fever, chills, sweats achy and tired. Slept the entire day when I woke up at 5:0pm I felt better had some sweats again that night but much better today. Yesterday was terrible.
60 2021-04-07 loss of personal independence in daily activities Extreme Tiredness, no strength, worn out, cannot perform normal activities an my normal level. Cont... Read more
Extreme Tiredness, no strength, worn out, cannot perform normal activities an my normal level. Continuing since vaccine Headache
60 2021-04-09 feeling abnormal I recieved the first Moderna Covid 19 Vaccine 1/08/2021 and there were no problems. The second Covid... Read more
I recieved the first Moderna Covid 19 Vaccine 1/08/2021 and there were no problems. The second Covid 19 Vaccine on 2/05/2021 went the same but after approximately two weeks I noticed soreness between my miidle and ring finger on my left hand along with soreness but thought nothing of it. the Pain eventually got worse. I went to my doctor on 3/25/2021 and was prescribed Naproxin and Voltaren Gel. The discomfort in my left had continues continues. There is selling above this area and the inside of my hand below those fingers hurts and my hand when I close it feels tight and this I atribute to the swelling. My doctor ran labs and all were negative even for Gout. There is a dense feeling in my left upper arm that comes and goes and some tingling. My left hand will have a burning feeling on the ring finger knuckle and experience pain when I fully open my hand. I have not injured my left hand in any way. I find it very unusual because I am right handed. I would appreciate any assistant if possible. I can send photographs if needed of my hand. Blood Work: URIC ACID 4.5 mg/dL 3.4 - 7.2 mg/dL General information Collected: 03/25/2021 11:39 AM from BLOOD Resulted: 03/25/2021 9:16 PM Result status: Final result
60 2021-04-09 memory impairment Tired one day after vaccination. Very tired two days after. Woke up from 20-minute nap on second d... Read more
Tired one day after vaccination. Very tired two days after. Woke up from 20-minute nap on second day in a strange mental state. I knew something was wrong with my cognition but could not articulate it to my girlfriend at the time. My memory of those conversations is fuzzy. Symptoms lasted about three hours with no recurrence since. Best description is that I didn't completely wake up from a dream state - could not clearly distinguish between what was real and what was left over from my dream. Very strange; have never experienced anything like it.
60 2021-04-10 feeling abnormal Dizziness. A worsening of my usual problem. Comes in waves and lasts all day/night. Difficulty walki... Read more
Dizziness. A worsening of my usual problem. Comes in waves and lasts all day/night. Difficulty walking. Intensified spacy, disequilibrium feeling.
60 2021-04-10 insomnia Muscle aches, major fatigue, insomnia
60 2021-04-10 loss of personal independence in daily activities Headache, mild Fever, mild Chills, mild Muscle and joint pain, mild Nausea, prevented normal activit... Read more
Headache, mild Fever, mild Chills, mild Muscle and joint pain, mild Nausea, prevented normal activities All lasted about 30 hours
60 2021-04-11 insomnia 3 hours of uncontrollable shaking starting at 2 am Friday. 3 hours Extreme painful urination. Total ... Read more
3 hours of uncontrollable shaking starting at 2 am Friday. 3 hours Extreme painful urination. Total body aches, joint pain, 3 days insomnia. 1 1/2 days Fever, headaches, Neck/shoulder pain. 3 days intermittent shooting pain left side of head. Still feeling somewhat tired and not 100% as of this report but getting better each day. Took Tylenol and let it ride its course.
60 2021-04-12 anxiety, sleep disorder, impaired work ability severe debilitating tinnitus in my right ear started approximately 2 weeks after the 2nd moderna sho... Read more
severe debilitating tinnitus in my right ear started approximately 2 weeks after the 2nd moderna shot on March 17. 2021. Intermittent mild to severe headaches. Unable to sleep as the pitch in ear is constant.
60 2021-04-13 confusional state Slight body aches and headache day of second injection. Moderate body aches and headache the day af... Read more
Slight body aches and headache day of second injection. Moderate body aches and headache the day after injection. Night after second day had severe headache, severe confusion, severe dizziness, severe nausea, unable to walk unassisted.
60 2021-04-13 insomnia Neuropathy; Arms very hot this morning; A lot of headache; Chills; Pain in his arm; Swelling in his ... Read more
Neuropathy; Arms very hot this morning; A lot of headache; Chills; Pain in his arm; Swelling in his arm; Couldn't sleep due to headache; Feeling that his head is boiling, very hot inside; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 60-year-old male patient who received COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Neuropathy. Concomitant products included AMLODIPINE for Blood pressure, NABUMETONE (RELAFEN) for Muscle relaxant, GABAPENTIN (NEURONTIN) for Pain in spine, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) and OMEPRAZOLE for Unevaluable therapy. On 06-Apr-2021, the patient received first dose (Intramuscular) 1 dosage form. On 06-Apr-2021, received first dose (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm), PERIPHERAL SWELLING (Swelling in his arm), INSOMNIA (Couldn't sleep due to headache), HEAD DISCOMFORT (Feeling that his head is boiling, very hot inside), HEADACHE (A lot of headache) and CHILLS (Chills). On 07-Apr-2021, the patient experienced FEELING HOT (Arms very hot this morning). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criteria medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), PAIN IN EXTREMITY (Pain in his arm), PERIPHERAL SWELLING (Swelling in his arm), INSOMNIA (Couldn't sleep due to headache), HEAD DISCOMFORT (Feeling that his head is boiling, very hot inside), FEELING HOT (Arms very hot this morning), HEADACHE (A lot of headache) and CHILLS (Chills) outcome was unknown. Treatment was not reported/ unknown. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
60 2021-04-13 mental impairment left sided headache, chills, lost track of time
60 2021-04-13 sleep disorder I had a mild rash after my 1st shot... really didn't remember till the dayn after my 2sd shot... i w... Read more
I had a mild rash after my 1st shot... really didn't remember till the dayn after my 2sd shot... i woke up with red itchy arms and legs. I had small welts around my waist and inner thighs. I showed my wife , she said use some anti itch cream in the bathroom.I did and it got better... went back to sleep. the next night i woke anain to really red and pissed off knees with welts all over my legs.. Treated again with cream. the next night...4-12-2021 it only started on both feet..kinda itchy with mild pain..no cream.. all good sofar..
60 2021-04-15 confusional state Within 24 hours of injection, fever of 101.0 for over 24 hours, headache, inability to keep awake or... Read more
Within 24 hours of injection, fever of 101.0 for over 24 hours, headache, inability to keep awake or keep eyes open, worsened my IBS and my neuropathy to the point of screaming, my body couldn't detect temperature changes even when inside room temp went from 70 to 86 degrees. Three times I fell into semi-conscious state and awoke within minutes not knowing where I was at or what was happening to me. Symptoms went away around 60 hours after injection.
60 2021-04-16 confusional state, agitation, disorientation, delirium, excessive sleepiness In summary this is a 60 year old male who was normal functioning presenting to hospital 4 days follo... Read more
In summary this is a 60 year old male who was normal functioning presenting to hospital 4 days following second moderna COVID-19 vaccination with AKI, Rhabdomyolsis, Confusion/Delirium with agitation, multiple acute brain infarcts, DVT, and multilobar pulmonary embolism. 24 hours following vaccination patient began to become slightly confused while driving his wife to her vaccine appointment. Symptoms progressed and included severe fatigue and muscle aches. Patient was taking tizanidine and oxycodone to manage muscle / body aches which had been prescribed for his chronic back pain issues. Patient was noted to be excessively sleeping, and also had fallen twice between vaccination and hospital presentation. 4 days following vaccination he presented to the emergency department with severe lethargy and confusion. He was admitted with presumption of overdose of medication, given activated charcoal. A CT of the head (4/11/2021) was completed which demonstrated No acute intracranial hemorrhage, extra-axial fluid collection or acute territorial infarct. Suggestion of a chronic lacunar infarct involving the left lentiform nucleus. Regions of low attenuation involving the cerebellar hemispheres, right greater than left, which, allowing for image degradation secondary to patient motion artifact, are likely artifactual in nature; follow-up is recommended to assess for stability/resolution.For first several days patient suffered delirium with agitation, he was disoriented to place and time. CK on admission, 4/11/2021, was 17,086, indicating rhabdo. Creatinine on admission was 4.39, indicating new acute renal failure. Liver enzymes were elevated with AST of 477 and ALT of 218. PT was 10.6, INR 0.99. ABG demonstrated metabolic acidosis with pH of 7.22, co2 45, HCO3 18.4. Over several days his mentation improved however was noted to still need light supplemental oxygenation. Because of the delirium a brain MRI was completed on 4/13/2021, which demonstrated acute ischemic infarcts on DWI sequence noting bilateral, right greater than left, acute cerebellar infarcts. Small acute lacunar infarcts at bilateral basal ganglia/genu internal capsule. Due to the infarcts a stroke workup was completed. Carotid duplex was performed and notable for only small bilateral carotid plaque. Renal ultrasound unremarkable. A CTA of the chest was completed on 4/15/2021 for continued hypoxemia, need for nasal cannula to maintain spo2 saturation. Findings included multilobar pulmonary embolism. Venous duplex dopplers of the lower extremities were also completed on 4/15/2021 demonstrated an isolated left popliteal vein DVT. No evidence of right leg DVT. Over several days CK and Cr returned to baseline / normal levels. He remains hospitalized and is still undergoing treatment.
60 2021-04-17 sleep disorder Itching all over my body, keeping me from sleeping.
60 2021-04-19 disturbance in attention Within 12 hours or so the following effects were noted. This was the first injection. 1. Injection ... Read more
Within 12 hours or so the following effects were noted. This was the first injection. 1. Injection site soreness/tenderness for up to 3 days. 2. General sore joints throughout my body. 3. Intense and long headache that lasted for up to 36 hours until Acetaminophen was final taken. The headache continued for another day or so at a lower intensity. 4. Fever up to 101 F and chills for up to 1.5 days. 5. General feeling of lack of concentration and being "hazy" in general condition. As of 4/20/2021 most effects have subsided. General treatment for discomfort was Acetaminophen after 36 hours from the injection date and time. The injection site is still sore but no mark or rash exists.
60 2021-04-20 feeling abnormal He had a fever and felt bad the day after the vaccine and then had a rash come up and was diagnosed ... Read more
He had a fever and felt bad the day after the vaccine and then had a rash come up and was diagnosed with Shingles.
60 2021-04-20 feeling abnormal After morning cup of coffee started feeling off. Spent the next day with fever and chills. Took Tyle... Read more
After morning cup of coffee started feeling off. Spent the next day with fever and chills. Took Tylenol did not help much. Was almost normal by noon the next day.
60 2021-04-24 loss of personal independence in daily activities, impaired work ability Four hours after the 2nd shot he had a stroke. The ambulance took him to Hospital where he was trans... Read more
Four hours after the 2nd shot he had a stroke. The ambulance took him to Hospital where he was transferred to another facility. He had to be in the hospital for 7 or 8 days. He is partially paralized on his left side. His symptoms were dizziness and collapse. Sweating profusly. He will have to go undergo extensive physical therapy, occupational therapy, doctors visits, and loss of his ability to work, or maintain any sort of regular daily living without assisstance. For the rest of his life. He was also the primary support of the household.
60 2021-04-25 mental status changes Hospitalized +Covid post vaccination with decreased mental status
60 2021-04-26 feeling abnormal Pt c/o headache, 2/10,"funny feeling" 15 mins after receiving vaccine. He noted that he was hx of mu... Read more
Pt c/o headache, 2/10,"funny feeling" 15 mins after receiving vaccine. He noted that he was hx of multiple allergies including anaphylaxis and sees allergist and gets allergy shots. He also noted that he has IDDM, has insulin pump. Self monitored.
60 2021-04-30 emotional distress, sleep disorder Sore arm at site of injection. Not improving after 24 hours. Disturbing sleep. Not happy.
60 2021-05-01 loss of personal independence in daily activities Started with hard to get up off of low seating area. weakness in chest muscles. legs,arms. severe pa... Read more
Started with hard to get up off of low seating area. weakness in chest muscles. legs,arms. severe pain in chest muscles,shoulders biceps, then radiating down in arms and hands.. trouble walking up stairs, raising arms above my head. getting dressed, washing my hair and general hygine issues. My hands started swelling very bad and continue. The amount of muscle weekness and pain i have i have never experienced in my lifetime. I have been to multiple doctors and have had many tests done. Prior to the Covid 19 vaccine i was a 60 yr old and now feel like a 90 yr old with many health problems.
60 2021-05-02 impaired work ability body aches from the top of head to the bottom of feet severe enough to miss a days work.
60 2021-05-03 excessive sleepiness, impaired work ability AFTER THE 2ND SHOT ON 4/30/21 AFTERNOON, PT HAD SORE ARM AT AROUND 7 PM AND WENT TO BED AT 8PM. HE ... Read more
AFTER THE 2ND SHOT ON 4/30/21 AFTERNOON, PT HAD SORE ARM AT AROUND 7 PM AND WENT TO BED AT 8PM. HE SLEPT THROUGH SATURDAY AND WOKE UP ON SUNDAY 5AM . HE NOTICED THAT CAN'T FOCUS HIS EYES TO READ OR SEE HIS COMPUTER SCREEN. BUT HE CAN SEE FROM BIG ITEMS FROM AFAR. HE TOOK THE DAY OFF FROM WORK ON MONDAY, AND SAID THAT HE HAS STILL HAS A HARD TIME READING OR SEEING COMPUTER SCREEN. HE HAS TO CLOSE HIS EYES FOR SEVERAL SECONDS AND FOCUS AGAIN BEFORE HE CAN READ ANYTHING. THIS CONDITION IS STILL ONGOING AS OF TODAY (5/4/21). HE SAID HE NEVER NEEDED READING GLASSES BEFORE. WE ADVISED HIM TO SEE EITHER TRY READING GLASSES IF THAT WILL HELP HIM OR IF NOT, HE CAN CONSULT WITH AN EYE DOCTOR FOR THIS REASON
60 2021-05-04 panic attack Panic attacks
60 2021-05-04 sleep disorder I haven?t had the chills like that in forever! It came in waves. You just lie there, hot, and ache a... Read more
I haven?t had the chills like that in forever! It came in waves. You just lie there, hot, and ache all over, then this wave of chills hits for maybe 5 seconds then dissipates. The 2 mins later, it happens again! And this goes on for an hour or more! I had to pee but was worried I?d be too cold to stand still. So I waited until I could not wait anymore. OMG! Trying to stand up! It?s as if my joints no longer worked! And when I did stand up I was dizzy as hell! The next day, utter exhaustion. I am so weak, it takes effort to move. Even breathing took work! I didn?t sleep all night as every position I lay in was uncomfortable and had twinges of chills. The amount of energy it takes to physically get up and walk to the bathroom is dumbfounding! This morning I am achy, hot and cold, exhausted, and just had a bout of dry heaves. I?m hoping to be able to get some sleep today.
60 2021-05-08 feeling abnormal Debilitating pain in left arm, exceeding that of a broken limb. 101*F fever, chills, sweat spells, ... Read more
Debilitating pain in left arm, exceeding that of a broken limb. 101*F fever, chills, sweat spells, body ache, headache, mental fog, upset stomach. I've never felt more sick in my life. Would have gone to ER however my wife suffered the same vaccination reaction (was vaccinated at the same time/location) and was unable to drive.
60 2021-05-14 impaired work ability 05/06/21 PATIENT RECEIVED 2ND DOSE OF MODERNA COVID 19 VACCINE AT JOBSITE CLINIC . PATIENT FELT FIN... Read more
05/06/21 PATIENT RECEIVED 2ND DOSE OF MODERNA COVID 19 VACCINE AT JOBSITE CLINIC . PATIENT FELT FINE AFTER THE CLINIC BUT LATER AT HOME STARTED FEELING SICK. PATIENT WAITED UNTIL SUNDAY 5/9/21 TO SEEK MEDICAL ATTENTION AT THE HOSPITAL AND WAS ADMITTED FOR STROKE. PATIENT REPORTED LOSS OF VISION IN ONE EYE. THE HOSPITAL NEUROLOGIST TOLD PATIENT THAT IT WAS DUE TO CLOTS IN HIS EYE. PATIENT IS WATING TO SEE AN OPTHALMALOGIST ABOUT THE EYE CLOTS. PATIENT HAS NOT BEEN BACK TO WORK SINCE FEELING SICK. EMPLOYER STATES HAS NOT RECEIVED ANY NOTICE FROM DOCTOR STATING ANY CAUSE OR RELATION TO VACCINE
60 2021-05-16 disturbance in attention, feeling abnormal Within 12 hours or so the following effects were noted. This was the second injection. Both inject... Read more
Within 12 hours or so the following effects were noted. This was the second injection. Both injections had similar effects. 1. Injection site soreness/tenderness for up to 3 days. Note : Different arm this time. 2. General soreness throughout my body. 3. Intense and long headache that lasted for up to 36 hours. Acetominophen and ibuprophen taken in series after approximately 20 hours. 4. Fever up to 100.5 F & chills for up to 2 days. 5. Some nausea for 2 days. 6. General feeling of lack of concentration and being "hazy" in general condition.
60 2021-05-24 hallucination Induced psychosis - extreme paranoia and hallucinations
60 2021-05-25 memory impairment, disturbance in attention Persistent Skin discoloration/rash on various parts of body, unable to focus, struggle to remember s... Read more
Persistent Skin discoloration/rash on various parts of body, unable to focus, struggle to remember simple things, persistent fatigue.
60 2021-06-03 mental status changes COVID vaccine on 2/27/2021 & 3/27/2021 (Moderna); tested positive for COVID-19 by PCR on 5/28/2021; ... Read more
COVID vaccine on 2/27/2021 & 3/27/2021 (Moderna); tested positive for COVID-19 by PCR on 5/28/2021; Medical records mention pneumonia, hypoxia, non-sustained ventricular tachycardia, altered mental status, cardiomyopathy, septic shock, and multiorgan failure; also tested positive for haemophilus influenza.
60 2021-06-06 sleep disorder He got his vaccine, had extreme pain in his right arm. He went back to the pharmacy and let her kno... Read more
He got his vaccine, had extreme pain in his right arm. He went back to the pharmacy and let her know that it hurt for several days and then went away, and he is still having the tenderness in the arm. It was so painful that he could not sleep on it due to the pain. He then had no problems up until 5/24/21 when he noticed some swelling on his ankle of his right leg. He put it in cold water to see if the swelling would go down and it did not. Then he didn't think about it again until it was stiff, swollen and wanted to turn to the right side and hard for him to drive and taking his anti-inflammatories. It progressively got worse and around 5/25/21 the swelling was severe and doubled in size and getting worse and on 6/3/21 he could not get his pants off due to the swelling and he went to the Dr. The next day. He had pain behind the knee, ankle, pain in the leg. He went to the doctor, and they sent him to the ER for an US which showed DVT of the right leg. He was informed that it was large and that it was in the thigh of his right leg and not returning blood to his heart. He was put on Eliquis 5 mg twice a day and is doing well for him. The swelling is a little better, the ankle is still swollen, and the leg is still swollen, the top of his foot is really bad, front of his leg and thigh. The knee does not seem to be swollen, but the thigh is. He has no problem with the left side. He is to follow up with his doctor on Thursday. He is on Hydrocodone as well for the pain as needed for his neck pain and lower back.
60 2021-06-07 memory impairment I NEVER GOT THE EXPERIMENTAL SHOT, BUT MY CO-WORKER DID AND SHED SPIKE PROTIENS IN THE OFFICE. I MU... Read more
I NEVER GOT THE EXPERIMENTAL SHOT, BUT MY CO-WORKER DID AND SHED SPIKE PROTIENS IN THE OFFICE. I MUST HAVE BEEN EXPOSED AND NOW HAVE SCALPED TONGUE, FATIGUE AND MEMORY PROBLEMS.
60 2021-06-08 sleep disorder L deltoid pain and intermittent tingling for 1.25 months after vaccination - which keeps him up at ... Read more
L deltoid pain and intermittent tingling for 1.25 months after vaccination - which keeps him up at night.
60 2021-06-14 sleep disorder pain left upper arm since injection, can't sleep on that side because of pain. Throbbing. No posit... Read more
pain left upper arm since injection, can't sleep on that side because of pain. Throbbing. No position helps. Tingles in fingers if picks things up. Can't put hand in hip pocket because it hurts to move arm back that far. Patient states he feels like there's a knot under left shoulder blade. Felt dehydrated when had lab draw 2 weeks ago (1 week after shot). Grip strength right 94.6lb, left 24.6lb, "makes it throb" when grasping.
60 2021-06-16 sleep disorder Shortly after second shot on 4/27/21, I took notice that I was feeling joint pain in my fingers, Art... Read more
Shortly after second shot on 4/27/21, I took notice that I was feeling joint pain in my fingers, Arthralgia or Arthritis. Maybe started after first shot. Sometime shortly after second shot really noticed pain and I started experiencing trigger finger locking at night in my right hand middle and ring fingers. NEVER had these symptoms or trigger finger experience prior to the vaccination. Felt the pain and occasional clicking in those finger joints and soon thereafter started having trigger finger locking that wakes me up at night. Never heard of trigger finger before and have since bought a brace to wear at night.
60 2021-06-17 impaired work ability Extreme pain in right arm and shoulder; unable to move right arm or shoulder. ER 2/22/2021 - Las Ve... Read more
Extreme pain in right arm and shoulder; unable to move right arm or shoulder. ER 2/22/2021 - Las Vegas two days later -(First, I did Teladoc first and they had me put a cold compress on it for a day or two (I tried cold and eat). ) Time kept going on and I kept not getting better. I waited two weeks to see my regular doctor and then I ended up in ER again because of pain. They gave me a shot of morphine. Sent me for an MRI and told me to see my doctor. My doctor sent me to another surgeon who had worked on my arm on my left shoulder . Months went by before I found out there was not anything physically wrong with the arm/shoulder. Trying to do Physical therapy twice a week - I'm unable to fully work - I'm a licensed aircraft technician. I'm doing a desk job and type with one hand.
60 2021-06-17 sleep disorder I have been suffering from extreme allergies as of 24 hours after the second shot. constantly runny... Read more
I have been suffering from extreme allergies as of 24 hours after the second shot. constantly runny and stuffy nose. sneezing , unable to sleep at night due to congestion. no fever this is not a cold as it has persisted for 2 months.
60 2021-06-20 impaired work ability It was a very busy day at the pharmacy. I was working as a floater pharmacist, and the pharmacist of... Read more
It was a very busy day at the pharmacy. I was working as a floater pharmacist, and the pharmacist of record told me they had some extra COVID shots and asked if I wanted one. I told him I did. He came back to me about 20 minutes later, after the paperwork had been completed, billed and my questionnaire filled out. He delivered the shot when I was standing and he was standing. I happened to glance over at him just as he injected me, and I thought he'd injected me too high. I emailed my scheduler and told her to get in contact with him and get him to review his technique for administering vaccines. Two weeks later, I started having pain in my left shoulder. Stretching exercises helped me maintain a certain controllable level of pain until about a month ago. My condition has since gotten quite a bit worse to the point I had to leave work early two weeks ago. I went to urgent care and saw the PA listed earlier in this report. I missed the next week at work, and have since seen an orthopedic specialist who administered a cortisone shot. I have been advised to keep a log of my progress and report back in 2-3 weeks.
60 2021-06-20 loss of personal independence in daily activities Approximately 2 to 3 weeks after my second Moderna shot, I began experiencing pain radiating from my... Read more
Approximately 2 to 3 weeks after my second Moderna shot, I began experiencing pain radiating from my shoulders to my hands. Within days after that, I started to feel my entire body becoming inflamed. I am experiencing excessive inflammation throughout my body. Lab tests conducted two days ago found my sedimentary rate at thirty-four. As a result of the inflammation, I have become unable to use my hands to perform menial functions as dressing myself, where my hands are unable to pull socks over my feet. The inflammation continues today. The pain level experienced as a result of the increased inflammation as resulted in significant diminished capacity for performing my daily routine.
60 2021-06-21 disorientation I just want to report that in the evening that I took the Moderna dose #2, I felt disoriented. My w... Read more
I just want to report that in the evening that I took the Moderna dose #2, I felt disoriented. My wife took my blood pressure. The reading was 88/58 and my pulse was 73. I am wondering if there is an interaction between the vaccine and the high blood pressure medication. I stayed lied down until I fell asleep. In he morning of 6/22/21 from 8:03 AM to 8:06 AM, lying down my readings were 99/65 and pulse 61. Sitting down the readings were 103/67, pulse was 66. Standing the readings were 103/74 and pulse was 80. Oxygen was 97. The last readings at 1:42PM after eating were 126/75 and pulse was 80. I am wondering if there is any correlation.
60 2021-07-07 insomnia Enlarged heart from 05-24-21 to 05-25-21. Insomnia from 05-22-21 to the present and continuing. Trea... Read more
Enlarged heart from 05-24-21 to 05-25-21. Insomnia from 05-22-21 to the present and continuing. Treatment received - none.
60 2021-07-07 sleep disorder Right after the vaccine had chills, lethargy, unable to sleep from shivering, coughing violently, sy... Read more
Right after the vaccine had chills, lethargy, unable to sleep from shivering, coughing violently, symptoms persisted for about a week, body aches. Several weeks later experienced same symptoms but worse, went to the urgent care. Given antibiotics, cough medication, about 5 different.
60 2021-07-11 disturbance in attention, sleep disorder Within 20 minutes of receiving the vaccine, I was experiencing extreme shortness of breath, my enti... Read more
Within 20 minutes of receiving the vaccine, I was experiencing extreme shortness of breath, my entire body hurt and I was dizzy to the point that I could not stand up without holding onto something. Since the injection, I have felt nauseous everyday, I cannot concentrate, I become fatigued just standing up. It's been almost six weeks since the injection & I still do not feel right. I fall asleep whenever I sit down and I've fallen asleep while driving.
60 2021-07-13 loss of personal independence in daily activities This may just be coincidental, but developed polymyalgia rheumatica within one month after the secon... Read more
This may just be coincidental, but developed polymyalgia rheumatica within one month after the second dose. Diagnosed with PMR on June 12, 2021. ESR 40 mm/hr, CRP 87.3 mg/L. Severe pain in hips and shoulders in the morning. Very difficult to get out of bed. Some stiffness in hands. Some stiffness in legs. Pain fades in late morning. Had been doing very high level of work/exercise during 3 months previous. Also got Shingles vaccine in January 2021. Currently on Prednisone 25mg/day. Pain reduced from level 7-8 to 2-3.
60 2021-07-17 feeling abnormal Heart is fluttering; Erratic heartbeat; Feeling a distress in the chest; Feeling like a "bu-bump, bu... Read more
Heart is fluttering; Erratic heartbeat; Feeling a distress in the chest; Feeling like a "bu-bump, bu-bump"; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart is fluttering) and ARRHYTHMIA (Erratic heartbeat) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Heart is fluttering) (seriousness criterion medically significant), ARRHYTHMIA (Erratic heartbeat) (seriousness criterion medically significant), CHEST DISCOMFORT (Feeling a distress in the chest) and FEELING ABNORMAL (Feeling like a "bu-bump, bu-bump"). At the time of the report, CARDIAC FLUTTER (Heart is fluttering), ARRHYTHMIA (Erratic heartbeat), CHEST DISCOMFORT (Feeling a distress in the chest) and FEELING ABNORMAL (Feeling like a "bu-bump, bu-bump") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. The patient reported that he was experiencing heart fluttering (2 or 3 times a day); at least twice a day, usually in the morning, he was feeling a distress in the chest, like a "bu-bump, bu-bump" for the last week and a half, along with erratic heartbeat, but not shortness of breath. The patient stated that he never felt this before. Treatment information was unknown. 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.; 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.
60 2021-07-19 loss of personal independence in daily activities, delirium, anxiety, disturbance in attention 60 yo M who developed delirium and was in ER 5/7/21 for this. Described by son/boss as difficulty fo... Read more
60 yo M who developed delirium and was in ER 5/7/21 for this. Described by son/boss as difficulty focusing x 2-3 weeks, diffuse body weakness, paranoia, anxiety. CT head was neg, pt was discharged home. outpatient MRI brain suggested Creutzfeldt Jakob disease CJD. He was seen by neurology, who confirmed CJD by LP, he is now nonverbal and dependent on all ADL's, going into hospice
60 2021-07-19 sleep disorder About one month after receiving first dose I noticed that it had been several weeks that I had not b... Read more
About one month after receiving first dose I noticed that it had been several weeks that I had not been getting a full night's sleep. Looking back I estimate it started the same week I received the first dose. Normally I can sleep 7-8 hours each night but from January on I rarely was able to sleep more than 3-4 hours at a time and woke up once or twice at night. Most nights I can fall asleep quickly.
60 2021-07-20 feeling abnormal, insomnia 2:00 the afternoon of the day of the vaccine Pt started feeling bad and did not sleep much that nigh... Read more
2:00 the afternoon of the day of the vaccine Pt started feeling bad and did not sleep much that night. Then about 7:00 the next morning he started vomiting and vomited all day until 3:00pm. He vomited so much he thought he was going to have a heart attack. Also, the gland in his underarm is very very swollen
61 2021-01-06 insomnia, anxiety Patient reports low back pain fever and anxiety began 2300 on the day of vaccination. He states he ... Read more
Patient reports low back pain fever and anxiety began 2300 on the day of vaccination. He states he is unable to sleep and feels an adrenaline rush but denies shortness of breath or chest pain. The fever and back pain resolved over the subsequent days however the jittery feeling persisted and he presented to the ED 1/6/2021. Patient was treated to diphenhydramine and symptoms resolved
61 2021-01-06 restlessness, nervousness, insomnia, anxiety, feeling abnormal Previously had Covid 19 May of 2020, received the Moderna vaccine on 12/31/20. That evening temp of ... Read more
Previously had Covid 19 May of 2020, received the Moderna vaccine on 12/31/20. That evening temp of 102.4, SI joint back pain, body aches until Saturday 1/2/21, also has shaky hands, feels anxious, nervous, racing thoughts, foggy + restless. Difficulty sleeping Blood pressure 156/101
61 2021-01-07 nightmare Moderna 10 PM, started to shiver, head ache freezing, fever, went to sleep, had night mares, took Ty... Read more
Moderna 10 PM, started to shiver, head ache freezing, fever, went to sleep, had night mares, took Tylenol, sleep till 3:30 PM, went back to sleep at 6Pm and woke up 6am.
61 2021-01-08 impaired work ability Fever CHILLS Narrative: NOT ABLE TO GO INTO WORK.
61 2021-01-17 loss of personal independence in daily activities Approx 10pm on day of admin, increasing soreness at injection site. Shaking chills overnight x 2. ... Read more
Approx 10pm on day of admin, increasing soreness at injection site. Shaking chills overnight x 2. Fever 102.9. Severe headache. Vomiting next morning. Bedridden 36 hours total.
61 2021-01-21 impaired work ability patient sent home from work on the morning of 1/21/2021 due to muscle pain, weakness, nausea. Symp... Read more
patient sent home from work on the morning of 1/21/2021 due to muscle pain, weakness, nausea. Symptoms worsened including decrease in o2 sats 72% (compared to normal mid-90%), patient was unable to ambulate due to muscle weakness/pain, pulse elevated to greater than 100 bpm. Ambulance was called and arrived to the home where patient resides at 8:55 am on 1/22/2021. Home director emailed symptoms to the pharmacy after the patient left for the ER. Pharmacist called home director to get additional info. As of 1:03 pm on 1/22/2021 patient has returned home after ER staff determined his symptoms were an adverse reaction to Moderna. He was advised by the ER staff to rest and drink plenty of liquids. Pharmacy advised home director to contact patient primary provider to report ADR and determine if the 2nd dose of Moderna is advised by the primary provider. The pharmacist will follow-up with the house director status on 1/23/2020 before 3 pm and will have any additional ADR's reported to the pharmacy and the patients primary provider
61 2021-01-22 insomnia Headache, head feeling very heavy and nausea; So far lasting for 4 days and not getting better; I to... Read more
Headache, head feeling very heavy and nausea; So far lasting for 4 days and not getting better; I took Tylenol but does not help. Last night was the worst couldn?t sleep all night
61 2021-01-27 impaired work ability At first I was fine, later that night my arm was hurting, then the next thing I know everything was ... Read more
At first I was fine, later that night my arm was hurting, then the next thing I know everything was hurting in my body. I had to take off work Tuesday and Wednesday. I think I also had a little fever. Today I am feeling better, the arm is just a little sore.
61 2021-01-30 impaired work ability 2nd shot stung a bit unlike 1st one. around 10:30am head felt woozy/slightly dizzy, left work at 1:3... Read more
2nd shot stung a bit unlike 1st one. around 10:30am head felt woozy/slightly dizzy, left work at 1:30pm dizzyness getting a little worst body started aching. fell asleep for about 30 minutes once home, bed at 9:30pm and started to shake violently like I was freezing but not cold, didn't feel like I had a fever, put on sweatpants and tshirt, turned on elec. blanket, I stopped shaking after about 45 minutes, took acetaminophen and 1 dose of zquil and fell asleep. up at 3:30am in pain, especially my left arm I couldn't lift with pain. called out of work all muscles and joints hurt, less pain with no movement, more acetaminphen every 6 hrs, started feeling better around 4Am Saturday
61 2021-02-01 disturbance in attention Received vaccine at 2:30 PM. By 8:30 PM was beginning to develop these side effects which lasted ar... Read more
Received vaccine at 2:30 PM. By 8:30 PM was beginning to develop these side effects which lasted around 24 hours: Headache, body aches (joint, muscles), generally tired and hard to focus. By second morning after vaccine, was back to normal. No treatment required.
61 2021-02-01 sleep disorder, insomnia Tightness in chest several times about 1 week and 2 weeks after 1st round. Difficulty sleeping on le... Read more
Tightness in chest several times about 1 week and 2 weeks after 1st round. Difficulty sleeping on left side 20 and 21 days following 1st round. Severe pain with inhaling AM of 22 day. Diagnosed at ER Hospital, with DVT left calf and PE both lungs. On Heparin IV for 4 days inpatient. Now on Eloquis 10mg BID for a week, 5mg BID thereafter.
61 2021-02-02 disturbance in attention Nausea Vomiting Cannot concentrate
61 2021-02-05 feeling abnormal Fever, headache, chills, muscle pain and brain fog.
61 2021-02-14 feeling abnormal Nasty headache which remained after acetaminohen/ibuprofen, congestion, fever, felt like my hesd ... Read more
Nasty headache which remained after acetaminohen/ibuprofen, congestion, fever, felt like my hesd was on someone else's body, aloofness, etc.
61 2021-02-15 sensation of foreign body approximately 1 week post 1st dose, patient had sensation of foreign body in throat; some pain in ne... Read more
approximately 1 week post 1st dose, patient had sensation of foreign body in throat; some pain in neck; & facial swelling
61 2021-02-20 poor quality sleep Starting around 5 pm on day of vaccine I started getting a low grade fever and it continued through ... Read more
Starting around 5 pm on day of vaccine I started getting a low grade fever and it continued through the next 24 hours. I took 2 500 mg Acetaminophen around 10 pm and went to bed. During the night I had some cold sweats and did not sleep well. The next day, I had chills and some body aches. I too 2 500 mg acetaminophen two more times during the day. I was fatigued with some body aches throughout the day. The next day was very similar to the 2nd day after the shot but no fever. It is now the 4th day after the shot and I feel back to normal.
61 2021-02-21 confusional state, restlessness, incoherent 2/20/21-61 year old male with decreased level of consciousness and hypoxia. I received a call from n... Read more
2/20/21-61 year old male with decreased level of consciousness and hypoxia. I received a call from nursing staff indicating that patient was having low oxygen saturations this AM and required oxygen. He needed only 1.5-2L by NC but was mouth breathing so mask was used and 4L due to mask. This brought his saturations back up. He has been quite drowsy since receiving his second COVID vaccine on 2/17/21 and has not been eating and drinking much. Today he is not responding to nursing staff in a coherent fashion. I met with him in his room along, RN. He did not wake to my voice or touch. On examination he is sleeping and using accessory muscles to breath, especially his abdomen. NC/AT, face symmetric. Lungs are clear to auscultation bilaterally anteriorly with no wheeze heard. No pretibial edema. 61 year old male with decreased level of consciousness. I will send patient to the ER due to his decreased level of consciousness and difficulty with breathing causing accessory muscle use despite normal respiratory rate of 17 but with hypoxia. I do believe his fever of 103 this AM was due to the COVID vaccine. I am concerned that he could be having a COPD exacerbation on top COVID vaccine symptoms and his bladder cancer is dragging him down along with dehydration from poor intake the past few days. I did call and speak with the ER provider and the EMS crew. They reported seeing a lot of this with the second COVID vaccine. 2/21/21-I received a call from nursing staff indicating that patient had worsening hypoxia with need for 8L of oxygen by mask. He was very restless and not making a lot of sense. He had receive Tylenol PR for a fever of 103 that was now only down to 101 and not budging. He was in the ER yesterday and diagnosed with possible Right middle lobe pneumonia on CT. He is already taking Levaquin. Due to his Oxygen need I did call to see about possible direct admission as he had a full work up the day before. The hospitalist was concerned that he might need BiPAP and so I did call and speak with the ER provider and she agreed that due to his new oxygen requirements he should be sent to the ER there and likely would need ICU. She was advised of the work up from yesterday so as not to repeat what wasn't needed. He was sent by ambulance due to his inability to sit up well. I received a call later that night from the intensivist in the ICU indicating that patient was reacting to the COVID vaccine most likely. He felt that there really was not much in the way of a pneumonia diagnosis as that has really not shown up on their imaging and all labs are normal including white count, CMP and blood gases. He is still requiring oxygen and is able to answer in sentences but is very drowsy and may be a bit confused. He has a minimal UTI and they will keep him given his low level of consciousness and hypoxia.
61 2021-02-21 insomnia On 2nd dose, 2/1/21: Severe body and deep joint aches, fever of 101, extreme chills, inability to sl... Read more
On 2nd dose, 2/1/21: Severe body and deep joint aches, fever of 101, extreme chills, inability to sleep, headache, profuse sweating lasting until 2/3/21. Still experiencing lingering arm pain at injection site.
61 2021-02-23 confusional state Moderna COVID 19 vaccine ADR. Approximately 14 hours after receiving the vaccine on 01/29/21 the pa... Read more
Moderna COVID 19 vaccine ADR. Approximately 14 hours after receiving the vaccine on 01/29/21 the patient starting experiencing extreme confusion, shaking, and then subsequently fell. EMS was called and was taken by ambulance to Hospital where he was admitted for 6 days. I called up follow up 02/16/21 and he still reports a daily persistent headache that migrates around the circumference of his head.
61 2021-02-24 irritability, sleep disorder Extreme exhaustion for more than 1 week; irritability; sleep interruption
61 2021-02-28 confusional state Patient was unable to get out of bed the whole day and missed all three meals. Patient had a fever ... Read more
Patient was unable to get out of bed the whole day and missed all three meals. Patient had a fever of 100.6 and had generalized weakness and malaise. Patient was also confused. Patient was experiencing tachypnea and shallow breathing.
61 2021-02-28 impaired work ability Was find 1st and 2nd day. 3rd day morning dizzy and loss of energy. A little nausea caused me to ... Read more
Was find 1st and 2nd day. 3rd day morning dizzy and loss of energy. A little nausea caused me to lay down, stay home from work. Rested. Took Tylenol and slept throughout the day. Got up around 12:30pm, felt better, did decide to go for a jog to get body temperature up. Jogged for 60 minutes, returned, ate and rested again. 4th day, felt much better, no dizzyness, still a little tired but maybe 85% energy level. 5th day back to normal.
61 2021-03-02 sleep disorder, amnesia, depression, anxiety, restlessness Had COVID vaccine on 02.11.21. States the next morning his anxiety was very high. States he did not ... Read more
Had COVID vaccine on 02.11.21. States the next morning his anxiety was very high. States he did not know who he was. Still experiencing a lot of anxiety at night. Admits to heart palpitations and hard time breathing. Can't sit still. Reports manic episodes and cycles of depression over the course of hours. Patient states it has gotten a tiny bit better. Tried trazodone which helps temporarily. Denies chest pain. Patient states he has no appetite. Palpitations resolved pretty quickly. Shortness of breath is described as tightness that comes with anxiety feeling. Resolves with shoulder massage. Occurring three times per day. Also admits to dry mouth. Patient admits to needing to sleep with multiple pillows or feeling like he had to sit up and couldn't lay down as shortness of breath would get worse. EKG in office on 2/24/21 showed ST-T changes and given symptoms patient was transferred to emergency room via ambulance. Work up in hospital was unremarkable and patient was diagnosed with pericarditis (unknown etiology) and prescribed NSAIDS from ER and discharged. Admission not required. Patient followed up to us as outpatient on 03.02.21. Patient felt much better and had not take motrin for 1 day. COVID testing obtained at this point (unclear why ER did not send it). Patient referred to outpatient cardiology given risk of cardiovascular disease, stress echo, and event monitor.
61 2021-03-04 confusional state, irritability started around 9am on 03/05/2021 with lower back muscle pain which I found odd, as the day has progr... Read more
started around 9am on 03/05/2021 with lower back muscle pain which I found odd, as the day has progressed a headache started and has kept on increasing on intensity, around 2pm I got sleepy and slept for about 30 minutes, the headache continue but now muscle pain discomfort is now down my knees and I started feeling body aches, I drove to pick up my child from school at 4pm and noticed confusion and irritability, once I got home took my temp and was 97.9 a few minutes later 98.2 now is 98.4, I called vaers at 8008227967 and the woman was not helpful at all in fact she was annoyed by the call, once I insist she hear what I have to say then she sounded nervous and wanted to get a statement but I decided to call moderna instead at 8666633762 and they listened and took my statement and said that more likely I will get a phone call, the side effects got so intense that I forgot I had a follow appointment with my primary care for a physical. I called them and they had me marked down for no show but once I explained they set up another follow up appointment.
61 2021-03-09 feeling abnormal Headache every day since vaccine, fatigue, sometimes in a "fog"
61 2021-03-10 disorientation A few minutes after client received the vaccination he felt light headed, dizzy, chest pain, disorie... Read more
A few minutes after client received the vaccination he felt light headed, dizzy, chest pain, disoriented, throat discomfort, and difficulty breathing. Was transported to Medical Center for further evaluation.
61 2021-03-11 insomnia Moderna COVID-19 Vaccine EUA Insomnia lasting until 4:00 AM the following morning.
61 2021-03-14 feeling abnormal For about 48 hours I felt out of it--lethargic, chilled, lack of appetite, slight headache, drainage... Read more
For about 48 hours I felt out of it--lethargic, chilled, lack of appetite, slight headache, drainage down back of throat. Last symptom still exists.
61 2021-03-14 feeling abnormal PT REPORTED AFTER RECEIVING VACCINE HE WAS A LITTLE FATIGUE & ONCE HE GOT HOME HE REPORT SEIZURE ACT... Read more
PT REPORTED AFTER RECEIVING VACCINE HE WAS A LITTLE FATIGUE & ONCE HE GOT HOME HE REPORT SEIZURE ACTIVITY. HE STATED FOR APPROXIMATELY 40 MINUTES "HE WAS JUST IN A DAZE & STARING" AND AFTERWARDS HE WAS FINE.
61 2021-03-16 mental status changes Pt completed his COVID-19 vaccine series, receiving the second vaccine 4 weeks after the first vacci... Read more
Pt completed his COVID-19 vaccine series, receiving the second vaccine 4 weeks after the first vaccine. Each time the patient received the vaccine, he presented to the emergency department the following day with the following signs and symptoms: AMS, tachycardia, fever (Tmax 104.5), lactic acid 3.8, CRP 1.65, CPK 298, Troponin T 0.107, WBC WNL.
61 2021-03-16 sensation of foreign body Patient had 2 waves of cold sweats during his 15 minutes waiting period. Patient also felt palpitat... Read more
Patient had 2 waves of cold sweats during his 15 minutes waiting period. Patient also felt palpitation or racing heartbeat. Throat became scratchy. Globus sensation. Denied swelling of the throat.
61 2021-03-17 sleep disorder The night of my vaccination I went to bed early. I was tired and a little achey. I woke up about 2:0... Read more
The night of my vaccination I went to bed early. I was tired and a little achey. I woke up about 2:00 AM with significant discomfort in my chest. My chest felt heavy and when I inhaled it felt like someone was squeezing both lobes of my lungs. I got out of bed and went to the bathroom to urinate. I went back to bed and tried to get back to sleep. The discomfort in my chest continued and seemed to get worse. I got back out of bed at about 2:45 AM and went downstairs where I walked around my living room to see if that would help me feel better. I continued to feel severe discomfort in my chest and lungs. I did not otherwise feel bad. I was not congested. I could still take a deep breath but it hurt to do so. I took my temperature and I did not have a fever. At about 3:00 AM I woke up my wife and she drove me to the emergency room at Medical Center. On the car ride to the hospital I started to feel much better. By the time I checked into the emergency room most of my discomfort had dissipated and only a very slight feeling of heaviness remained in my chest.
61 2021-03-20 incoherent Woke from sleep at 12:45 a.m. on 3/19 with severe pain at injection site. Got up to urinate and take... Read more
Woke from sleep at 12:45 a.m. on 3/19 with severe pain at injection site. Got up to urinate and take Tylenol. While in bathroom, became dizzy, broke into sweats, and felt I was about to faint. I went to my knees holding onto counter. My wife came in to help me in bathroom. She observed I was incoherent but uttering moaning sounds and breathing heavily. She called 911. While on phone I came to and vomited into sink. It appeared I had not digested anything from dinner that night. After vomiting (1x) I felt much better. First responders reported normal vital signs. I did not go to E.R. that night but went to Urgent Care later that morning and all seemed fine.
61 2021-03-24 feeling abnormal Foggy headed, sometimes a little dizzy, off balance Fatigue More aches and pains than usual sometime... Read more
Foggy headed, sometimes a little dizzy, off balance Fatigue More aches and pains than usual sometimes a feeling of shortness of breath
61 2021-03-26 insomnia, impaired work ability On the evening of February 24th after the I received the vaccine, I had severe pain on my left lower... Read more
On the evening of February 24th after the I received the vaccine, I had severe pain on my left lower back radiating all the way to my left foot with tingling. I didn't sleep for 4 nights and I had difficulty walking. On February 28th I went to Emergency Room and I was given a Toradol shot. On Monday, March 1st I went to my primary doctor and gave Prednisone, Gabapentin and Meloxicam tablets then I was given 9 days off from work. Up to the present, I'm under physical therapy and I still have on and off pain on my left leg.
61 2021-03-27 feeling abnormal, memory impairment, depressed mood Severe brain fog for days. Dizziness and off balance. Forgets what he's talking about mid sentence... Read more
Severe brain fog for days. Dizziness and off balance. Forgets what he's talking about mid sentence. Pain at injection site. Feels funky still after 4 days.
61 2021-03-28 feeling abnormal Heart Palpitations or arithmia (felt like vibrator in chest a few hours after vaccination and lasted... Read more
Heart Palpitations or arithmia (felt like vibrator in chest a few hours after vaccination and lasted at least 1 hour). Eventually went away. Then two days later, Tinitus and lethargy similar to past MS symptoms, felt "off".
61 2021-03-29 amnesia Memory problems, some increase in headaches. Also issues with balance and bumping into walls. Stil... Read more
Memory problems, some increase in headaches. Also issues with balance and bumping into walls. Still to not have smell or taste. These symptoms have continued for 3 months after vaccine. Initially after vaccine became acutely ill with high fevers 102-104 f. Also became severely weak with severe muscle aches and severe headaches. This lasted for 7 days with worst at the beginning. Then I have had the memory loss and equilibrium and loss of ability to spell simples words that I had no issues with before. I have had these symptoms for 3 months. I thought it would all get better but it has not. I thought I better let you know these problems. I did not want to but because they have continued I thought I better tell you.
61 2021-03-29 insomnia Chills, shaking, cold, sleeplessness - 12 hrs after vaccination for a period of at least two hours. ... Read more
Chills, shaking, cold, sleeplessness - 12 hrs after vaccination for a period of at least two hours. Exhaustion, fatigue, diarrhea for next three days after vaccination
61 2021-03-30 insomnia Extreme pain in shoulder after vaccination that lasted 3 days. Injection was given at the top of my... Read more
Extreme pain in shoulder after vaccination that lasted 3 days. Injection was given at the top of my shoulder. I did not have the rash or redness at the injection site. I could not move my arm without felling pain and could not sleep well because of it.
61 2021-04-02 anxiety Numbness, tingling, entire body. Neuropathy, extreme exacerbation. Face, tongue, hands, painful numb... Read more
Numbness, tingling, entire body. Neuropathy, extreme exacerbation. Face, tongue, hands, painful numbness. Very weak, exhausted, and very dizzy. Also, increased blood pressure and increase of heart PVC's. Symptoms ebb and return. It's been 8 days and still dizzy, weak, and neuropathy is so bad that it feels like I'm slightly paralyzed on the left side of my body.
61 2021-04-05 insomnia, restlessness Inability to fall asleep at regular bedtime and through the night. Restlessness. 2 other friends ... Read more
Inability to fall asleep at regular bedtime and through the night. Restlessness. 2 other friends reported same issue after Moderna Dose 2
61 2021-04-06 insomnia Swelling of groin and testicles; Swelling of groin and testicles; Pain on hands and feet; Weakness; ... Read more
Swelling of groin and testicles; Swelling of groin and testicles; Pain on hands and feet; Weakness; Chills; Generalized pain; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized pain), SWELLING (Swelling of groin and testicles) and TESTICULAR SWELLING (Swelling of groin and testicles) in a 61-year-old male 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 No adverse event (No medical history reported). On 10-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 INSOMNIA (Insomnia). On 26-Mar-2021, the patient experienced PAIN (Generalized pain) (seriousness criterion medically significant), ASTHENIA (Weakness) and CHILLS (Chills). On 27-Mar-2021, the patient experienced SWELLING (Swelling of groin and testicles) (seriousness criterion medically significant), TESTICULAR SWELLING (Swelling of groin and testicles) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain on hands and feet). At the time of the report, PAIN (Generalized pain), INSOMNIA (Insomnia), ASTHENIA (Weakness) and CHILLS (Chills) was resolving and SWELLING (Swelling of groin and testicles), TESTICULAR SWELLING (Swelling of groin and testicles) and PAIN IN EXTREMITY (Pain on hands and feet) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
61 2021-04-06 restlessness, insomnia, sleep disorder Got his vaccine, and he was told to sit in a chair for about 15 minutes to see if he would have a re... Read more
Got his vaccine, and he was told to sit in a chair for about 15 minutes to see if he would have a reaction. At first he did not have any reaction. As time went on he developed a slight headache, then his body felt warm. When he went to bed he tried to sleep and he could not and turned from side to side, and still could not rest, very restless, insomnia. Then he noticed a pain in his right leg at the bottom by his ankle. He then noticed that his right side was sort of numb and tingling, which went on for about 15 minutes and then it stopped. The headache has subsided. He has the soreness in the arm, but not like it was before. All of his symptoms are subsiding. He did not take anything for these symptoms.
61 2021-04-09 feeling abnormal, sleep disorder Moderna COVID-19 Vaccine EUA. Approx 10 hrs post-vacc, sore arm & feeling that my body was "fighting... Read more
Moderna COVID-19 Vaccine EUA. Approx 10 hrs post-vacc, sore arm & feeling that my body was "fighting something" (much as after other vaccs/inf post-BMT (shingrix, reclast). At 12 hrs post-vacc, feeling feverish, chills, body aches, trouble sleeping, temp=98.6, pulse=72 (unusual for me. Normal vitals: temp=97.2 to 97.5, pulse=55-62). Trouble sleeping throughout the first night, only 5 hrs sleep maximum. Next morning, at 23 hrs post-vacc, continued trouble sleeping, body aches, chills, sore arm, temp=99.7, pulse=90 (at complete rest, very unusual for me). FYI, i was well hydrated. At 27 hrs post-vacc all same symptoms plus headache, significant malaise, brain fog, remained in bed all day, temp=99.5, pulse=75. Fever.....Fever broke at aprox 35 hrs post-vacc, began to feel a bit better, temp=98.7, pulse=78. At 38 hrs post-vacc (4/10 at 2:00am), i got up from bed to pee, feeling alot better & vitals approaching normal, temp=97.8, pulse=58. At 43 hrs post-vacc (4/10 @ 9am), feeling tired but otherwise recovered, vitals back to my normal ranges: temp=97.2, pulse=56. FYI, after dose #1 of Moderna covid-19 vacc, i had sore arm, mild feeling that my body was "fighting something," and trouble sleeping the first night, but NO fever and no other adverse symptoms.
61 2021-04-09 excessive sleepiness Sore arm, prolonged fever lasting 32 hours so far, the fever has not subsided yet. Extreme tiredness... Read more
Sore arm, prolonged fever lasting 32 hours so far, the fever has not subsided yet. Extreme tiredness, I have slept for almost 30 hours. Aches and a side ribs are sore. I also fainted and fell several times during the night.
61 2021-04-09 irritability I woke up with cold chills. Throughout the day I had fatigue in all extremities, irritability and se... Read more
I woke up with cold chills. Throughout the day I had fatigue in all extremities, irritability and sensitivities to the skin on my arms. I felt discomfort while urinating throughout the day. I had a low grade fever later in the day.
61 2021-04-11 disorientation Lethargic, disoriented, fever 103.7, muscle weakness, joint pain- needed help to walk, weakness, j... Read more
Lethargic, disoriented, fever 103.7, muscle weakness, joint pain- needed help to walk, weakness, joint pain and fever lasted 2days. Still feeling a little disoriented, balance off a little after 6 days and sore arm,
61 2021-04-11 feeling abnormal, sleep disorder After 12 hours of being vaccinated was bed ridden, high fever, unable to walk for 12 hours. , skin ... Read more
After 12 hours of being vaccinated was bed ridden, high fever, unable to walk for 12 hours. , skin color turned grayish and very pale for 24hours. Broke out in hives, particularly on back and chest area. Several bumps per sq/in., unbelievably itchy. 5 days later hives seriously affect sleeping habits and can barely sleep at night. Have had mild eczema for years, 95% out breaks occur on hands and forearms, never back. Vaccine cleared up eczema on fingertips and one small spot on forearm. Now 30% of body covered in hives (ie, small itchy bumps). 5 days later still have slight headache, thinking still a little cloudy.
61 2021-04-12 hallucination Patient stated he experienced dizziness and hallucinations off-and-on for 5 hours.
61 2021-04-12 insomnia Received second Moderna vaccine on 3/12/21, and on 4/1 awoken with intense pressure in ears. Con... Read more
Received second Moderna vaccine on 3/12/21, and on 4/1 awoken with intense pressure in ears. Contacted physician who prescribed antibiotics, and hydrocortisone ear drops on 4/2.. The pain intensified along with constant loud ringing in the ears. Unable to sleep and with pain in both ears along with sensitivity to sounds increased. Finally went to ER on 4/5. Was diagnosed with Tinnitus. This problem with the intense and constant ringing in both ears has occurred after the second dose of the Modera vaccine.
61 2021-04-12 sleep disorder about 12 hours after the injection this past Sunday, I experienced body chills, headache, and fever ... Read more
about 12 hours after the injection this past Sunday, I experienced body chills, headache, and fever ( 101.8) unable to sleep, seemed to get better the next morning , then occurred again that afternoon. I recovered that evening and felt better the following day. I also experience the same symptoms when I received my first Moderna vacation on 3/14/21. I did have Covid at the end of December 2020.
61 2021-04-13 sleep disorder I received my 1st shot on April 8, 2021, later that night I took a shower and went to bed. Around ... Read more
I received my 1st shot on April 8, 2021, later that night I took a shower and went to bed. Around 0100AM on April 9, 2021, I started to have chills and a fever which lasted all night until around 10 am the next morning, after the chills and fever left I lost my appetite and my body ached all over. I had flu-like symptoms for 3 days and I was OK after that time period.
61 2021-04-14 anxiety Pt presented to clinic today for his 2nd dose Moderna vaccine at approx 1033. Pt was brought back t... Read more
Pt presented to clinic today for his 2nd dose Moderna vaccine at approx 1033. Pt was brought back to conference room and was given his 2nd dose Moderna vaccine at approx 1040. Pt reported no allergies to medications, no severe allergic reaction in the past. Pt states doing fine with the 1st dose of the Moderna vaccine. Pt was waiting his observation time of 15 min and began itching face, arms, and legs. Nurse questioned pt if he was feeling ok? If he is itching? Pt reports that he is itching but he has some anxiety but that he is hanging in there. Nurse offered pt some water. Pt declined. Pt started clearing throat and coughing. Nurse questioned pt if he was still feeling ok and again offered pt some water. Pt declined. Pt reports that he is feeling ok. Pt's timer alarmed and pt got up ready to leave. When asked if he is doing ok, pt reports that he is. Nurse questioned pt if his cough is normal for him and pt reports that he has asthma and proceeded to walk out. Pt was escorted by nurse. Nurse questioned pt again if he is feeling ok. Pt states that he is. Nurse notifies pt that if he not feeling ok then he should come back. Pt states understanding and exits building. Nurse seen pt returning back to clinic from window. Nurse meets pt upon entering building. Pt reports trouble breathing. Nurse observes that pt has voice change, trouble completing sentences, cough is worsening, and itching is intensified. Pt grabs the wall while ambulating. Nurse provided stand by assist. Nurse immediately escorts pt back to exam room and gets assistance from nursing staff and provider presents to exam room immediately. Crash cart arrives. Epi 0.3mg autoinjector administered IM to LT at approx 1100. IV NS ordered. At approx 1104 pt O2 sat of 98% on RA, HR 96. Approx 1105 Duo Neb administered via nebulizer mask as ordered. Approx 1107 IV inserted to RAC with 18g on 2nd attempt. Approx 1108 Diphenhydramine 25mg/0.5ml administered IV as ordered. SoluMedrol 125mg/2ml administered IV as ordered. Pt O2 sat 97% on RA, HR 102. Approx 1110 pt BP 140/85, O2 sat of 93% on RA. Pt has coughing spell. EMS was called. Approx 1113 pt O2 sat 90% on RA. Ongoing coughing spell. Approx 1114 O2 2L administered via mask as orderd by provider. Pt's wife contacted via pt's cell phone. Approx 1116 Epi 0.3mg administered IM to LT as ordered. Pt O2 sat 97% on 2L O2, HR 87. Pt reports itching getting worse. Approx 1121 Diphendydramine 25mg/0.5ml administered IV as ordered. Approx 1123 pt O2 sat 97% on 2L O2, HR 119. Approx 1125 EMS arrived. Approx 1127 BP 183/75. Pt taken by ambulance with EMS to ER at approx 1135. Report called to ER by provider. ER transfer form faxed to ER.
61 2021-04-20 nervousness Mild headache, muscle stiffness, lack of energy, Uncontrollable shaking chills overnight followed by... Read more
Mild headache, muscle stiffness, lack of energy, Uncontrollable shaking chills overnight followed by low grade fever.
61 2021-04-21 sleep disorder Headache, body aches (especially legs), extreme chills with extremities shaking, probable fever, inj... Read more
Headache, body aches (especially legs), extreme chills with extremities shaking, probable fever, injection site considerably more painful/tender than with first dose, inability to sleep all night, a bit light headed, weak and balance problems while walking, dry mouth After roughly 6 hours, most symptoms gone or greatly improved. Still had some headache and body aches, felt mildly feverish, injection site still painful, fatigue due to lack of sleept
61 2021-04-22 sleep disorder Initial reaction in the first 48 hours was as expected (chills, sweats on the first night, sweats th... Read more
Initial reaction in the first 48 hours was as expected (chills, sweats on the first night, sweats the second night). Starting starting 54 hours after the vaccine, chills began to recur, accompanied by severe indigestion and gas. In the evening of the third day after the vaccine, chills were extreme and excessive stomach gas and bloating was experienced, with occasional sharp gas pains in the abdomen. While the gas symptoms moderated overnight, they returned in the afternoon and overnight of day 4. Experiencing fatigue, but this could be related to lack of sleep due to the symptoms. This is day 5 and the gas and bloating remain but appear to be moderating.
61 2021-04-24 restlessness Headache, chills, fever,( pain ,tenderness , edema, redness & hot to the touch of injection site), f... Read more
Headache, chills, fever,( pain ,tenderness , edema, redness & hot to the touch of injection site), fatigue, dizziness, muscle & joint pain, restlessness. Increased fluid intake & took Tylenol ES every 6 hours, rested as much as possible.
61 2021-04-27 feeling abnormal, agitation On 04/28/2021 - started feeling brain fog. Nausea. Several times I felt like I am having an out of... Read more
On 04/28/2021 - started feeling brain fog. Nausea. Several times I felt like I am having an out of body experience and I become easily agitated
61 2021-04-28 insomnia, restlessness Injection site redness...more than 5 days. Arm soreness has decreased daily. Initial noticed eff... Read more
Injection site redness...more than 5 days. Arm soreness has decreased daily. Initial noticed effect besides slight soreness in arm... Chills 10 to 11 hours after injection. These increased for next 12 hours. Weakness, moderate to severe nausea( vomiting).. lasted 2 days. Not able to keep food down. Headaches...slight to moderate migraine headache..3 days..in duration...decreasing in severity daily. On second night and third night.....profuse sweating on Second night....restless and little sleep. Third night slight sweats in early morning. After 4 days....eating and getting energy back from a really bad experience.
61 2021-04-29 sleep disorder, abnormal dreams symptoms began at: April 28, 3pm No appetite, lethargy, nauseous, high fever (102 - 103+), sleeping ... Read more
symptoms began at: April 28, 3pm No appetite, lethargy, nauseous, high fever (102 - 103+), sleeping for 16 hrs out of 24 hrs with highly disruptive sleep, interrupted by vomiting, dry heaving, delusional fever dreams, tiredness and low grade fever for another 12 hours No medical tests given No physician called
61 2021-04-30 feeling abnormal, confusional state Fainting; vertigo; spins; dizziness; confusion; fogginess; the craps; heart running; headache; This ... Read more
Fainting; vertigo; spins; dizziness; confusion; fogginess; the craps; heart running; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainting) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history reported. Concomitant products included LOSARTAN, METOPROLOL and HYDROCHLOROTHIAZIDE for an unknown indication. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced VERTIGO (vertigo; spins), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (fogginess), DIARRHOEA (the craps), HEART RATE INCREASED (heart running) and HEADACHE (headache). On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting), VERTIGO (vertigo; spins), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (fogginess), DIARRHOEA (the craps), HEART RATE INCREASED (heart running) and HEADACHE (headache) was resolving. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. Treatment in the ER included "methazine." The patient noted that he will not be getting the second planned vaccine dose. Company Comment: This case concerns a 61-year-old male with a serious unexpected event of syncope, and nonserious unexpected vertigo, dizziness, heart rate increased, diarrhea, confusional state, feeling abnormal, and expected headache. Event onset with unknown latency after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 61-year-old male with a serious unexpected event of syncope, and nonserious unexpected vertigo, dizziness, heart rate increased, diarrhea, confusional state, feeling abnormal, and expected headache. Event onset with unknown latency after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
61 2021-05-03 excessive sleepiness extreme fatigue leading to frequent sleep day and night for 2 full days, lethargic, joint pains, c... Read more
extreme fatigue leading to frequent sleep day and night for 2 full days, lethargic, joint pains, chills, metallic taste, mild cough, no fever - some improvement with paracetamol 500mg QID. Metallic taste remains to date (5/4/21), though improved. I am a physician, if not i would have panicked and gone to the ER.
61 2021-05-04 feeling abnormal He is newly hypertensive with blood pressure 160/72 with continued cold sweats/"blah" feelings for t... Read more
He is newly hypertensive with blood pressure 160/72 with continued cold sweats/"blah" feelings for the month since his second covid vaccine. Suspect he's having symptomatic hypertension. BP has never been uncontrolled recently and he was last seen 3/21
61 2021-05-06 impaired work ability, disorientation 3:30 in the morning freezing cold chills/ dry heeves/ aching bones and body/ couldn"t keep food down... Read more
3:30 in the morning freezing cold chills/ dry heeves/ aching bones and body/ couldn"t keep food down /or take any meds/had to miss work/ disoreinted/ just kept sleeping all day and night felt better the next morning... went to work on Thursday 05/ 06/ 2021 felt about 95 % better in about 24 hours......no food and no meds and very week....feeling better now, besides tender stomach from dry heeving
61 2021-05-11 insomnia insomnia
61 2021-05-12 feeling abnormal, disturbance in attention patient was not concentrating well and asks not to be asked too many questions; it does not let him ... Read more
patient was not concentrating well and asks not to be asked too many questions; it does not let him walk almost; he can walk indoors and he runs out of oxygen, he use oxygen all the time; lot of back pain; sweats a lot, when he is not cold he sweats a lot; arm pain; tired/exhausted; lost consciousness/couldn't even remember the days; woke up all the time, he could not breathe/breathing like panting; woke up very bad; patient had no balance; did not feel well; got very hungry; got very thirsty; sneezing; started to feel silly; running nose/running nose was getting stronger and stronger; patient has been dead for two or three days day and night; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Emphysema and COPD. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced HUNGER (got very hungry), THIRST (got very thirsty), SNEEZING (sneezing), FEELING ABNORMAL (started to feel silly), RHINORRHOEA (running nose/running nose was getting stronger and stronger) and UNEVALUABLE EVENT (patient has been dead for two or three days day and night). On 27-Apr-2021, the patient experienced DYSPNOEA (woke up all the time, he could not breathe/breathing like panting), MOOD ALTERED (woke up very bad), BALANCE DISORDER (patient had no balance) and MALAISE (did not feel well). On 28-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days) (seriousness criterion medically significant). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (patient was not concentrating well and asks not to be asked too many questions), GAIT DISTURBANCE (it does not let him walk almost), OXYGEN CONSUMPTION DECREASED (he can walk indoors and he runs out of oxygen, he use oxygen all the time), BACK PAIN (lot of back pain), HYPERHIDROSIS (sweats a lot, when he is not cold he sweats a lot), VACCINATION SITE PAIN (arm pain) and FATIGUE (tired/exhausted). At the time of the report, LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days), HUNGER (got very hungry), THIRST (got very thirsty), SNEEZING (sneezing), FEELING ABNORMAL (started to feel silly), RHINORRHOEA (running nose/running nose was getting stronger and stronger), MOOD ALTERED (woke up very bad), BALANCE DISORDER (patient had no balance), MALAISE (did not feel well), DISTURBANCE IN ATTENTION (patient was not concentrating well and asks not to be asked too many questions), GAIT DISTURBANCE (it does not let him walk almost), OXYGEN CONSUMPTION DECREASED (he can walk indoors and he runs out of oxygen, he use oxygen all the time), BACK PAIN (lot of back pain), UNEVALUABLE EVENT (patient has been dead for two or three days day and night) and VACCINATION SITE PAIN (arm pain) outcome was unknown and DYSPNOEA (woke up all the time, he could not breathe/breathing like panting), HYPERHIDROSIS (sweats a lot, when he is not cold he sweats a lot) and FATIGUE (tired/exhausted) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Treatment medication included acetaminophen for arm pain and a lot of back pain and other medications included Steroids and oxygen. Concomitant medications included High blood pressure medicines, high blood sugar medicines ("under control"), cholesterol medicines and medicines for his lung disease. 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 2021-05-12 feeling abnormal A little fatigue feeling in early evening. Slight deltoid soreness. Next morning had slight fever ... Read more
A little fatigue feeling in early evening. Slight deltoid soreness. Next morning had slight fever 99.7. Generalized tiredness. Feeling like my body was glowing. Fever continued into evening. 99.4 in late evening. On 5/10 at about 4:30 am woke up in full body sweat. Felt better overall a few hours later. Went for a 2 to 3 mile walk and was ok. On 5/11 I woke up sweaty again at 5:30 am. Felt ok during the day. That was the main extent of my reactions.
61 2021-05-18 insomnia Hot, sweating, clammy. Feeling unwell! Can't sleep for days! Sinus and brain pressure pain!
61 2021-05-19 confusional state Pt walked in as a 'walk-up' for a COVID vaccine and was advised that this shot would be Moderna sinc... Read more
Pt walked in as a 'walk-up' for a COVID vaccine and was advised that this shot would be Moderna since that was the only COVID vaccine that we were administering that day. Pt signed consent form, signed out at the register and received his shot. Upon counseling for his return date and side effects to expect, he expressed that he thought this was the 'one-dose.' He seemed to be confused about which shot was which and told me 'the CDC said this would be the one-dose here.' He was very upset even though I exclaimed that we clarified this was the two-dose Moderna vaccine before the shot was given.
61 2021-05-23 hallucination Hallucination, dizziness, body achy
61 2021-05-24 impaired work ability, insomnia Immediate chills and fever 101 degree out of work for 2 1/2 weeks morning fatigue and fever both kn... Read more
Immediate chills and fever 101 degree out of work for 2 1/2 weeks morning fatigue and fever both knees/ inflamed could not walk loss of appetite severe insomnia chest pains went to hospital fear of heart attack
61 2021-05-25 depression Fatigue, 24 hour joint pain, mild depression.
61 2021-05-26 loss of personal independence in daily activities Losing breathe; Paralysis of face; Bells Palsy; Guillain-Baire syndrome,; Numbness in hands; Could n... Read more
Losing breathe; Paralysis of face; Bells Palsy; Guillain-Baire syndrome,; Numbness in hands; Could not swallow; Tingly in hands; Impaired vision; Speech impairment; Could not walk; Paralysis in his head from neck up.; Pneumonia; Totally impaired; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralysis in his head from neck up.), PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Plasmapheresis in April 2021, Feeding tube insertion in April 2021, Tracheostomy tube insertion in April 2021 and Mechanical ventilation in April 2021. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARALYSIS (Paralysis in his head from neck up.) (seriousness criteria hospitalization, disability, medically significant and intervention required), PNEUMONIA (Pneumonia) (seriousness criterion medically significant), DYSPNOEA (Losing breathe) (seriousness criteria hospitalization, medically significant, life threatening and intervention required), FACIAL PARALYSIS (Paralysis of face) (seriousness criterion hospitalization), BELL'S PALSY (Bells Palsy) (seriousness criterion hospitalization), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), HYPOAESTHESIA (Numbness in hands) (seriousness criteria hospitalization and medically significant), DYSPHAGIA (Could not swallow) (seriousness criteria hospitalization and medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired) (seriousness criterion disability), PARAESTHESIA (Tingly in hands) (seriousness criterion hospitalization), VISUAL IMPAIRMENT (Impaired vision) (seriousness criterion hospitalization), SPEECH DISORDER (Speech impairment) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization). At the time of the report, PARALYSIS (Paralysis in his head from neck up.) had not resolved and PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) outcome was unknown. Non-drug therapy included: The patient had 7 plasmapheresis, trachea to breathe, feeding tube and put on a ventilator. 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-2021-141559 (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.
61 2021-06-03 feeling abnormal Pt reports he has had symptoms of nausea, fatigue, headache, weakness, fuzziness , sinus burn and me... Read more
Pt reports he has had symptoms of nausea, fatigue, headache, weakness, fuzziness , sinus burn and metallic teste for about 6-7 days after he had 1st Moderna shot (021C21A). Other than that, everything is fine.
61 2021-06-06 feeling abnormal 1) within 1 week of having received 2nd dose of Moderna vaccine I developed a low grade fever and wa... Read more
1) within 1 week of having received 2nd dose of Moderna vaccine I developed a low grade fever and was quite lethargic soon after awakening; (May/15 - May/21); 2) I started feeling less lethargic but something was not right; 3) on Sunday 5/23 - I awoke to a fever and night sweats; this would continue every night I tried to sleep from Sunday 5/23 - Friday June/04. 4) I reported this to my primary care physician and a blood draw appt was made for May/27 and face-face annual check-up on June/1st. 5) Several of my blood marker results were concerning and I was asked to repeat blood test and include Urine test. I am being told that I have markers for potential Multiple Myeloma.
61 2021-06-15 insomnia started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped ... Read more
started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination; slept a lot after the shot; covid like flu symptoms; very weak/very weak feeling; terrible diarrhea; Zero appetite now for 3 days although eating once a day; no longer able to sleep at night; pain in my heart/pain moved from left side heart area and slid toward my left side; neck glands swelled last week/2swollen neck glands; very tired/very fatigue; Bad headache; chills (no fever); heart attack-like pain; lost 20 pounds of his body in the next 24 hours,weight was 184/185; sweat really bad/terrible night sweats; I had pain which I felt like was in the right kidney and lower right abdominal area; I had pain which I felt like was in the right kidney and lower right abdominal area; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (heart attack-like pain) and POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Herpes virus infection (Improved after shingles vaccine. February 2020 second dose. October 2019 first dose.) on 24-Jun-2008. Previously administered products included for Shingles: Shingles vaccine in February 2020. Past adverse reactions to the above products included No adverse event with Shingles vaccine. Concurrent medical conditions included HIV disease since 18-Feb-1988, Renal agenesis, Drug allergy (Allergy to Floriquins), Allergy to chemicals (Contrast dye allergy), Asthma since 24-Jun-2008, Mitral valve disease since 12-Apr-2010 and Diarrhoea (Improved with daily morphine ER.) since 01-Oct-1996. Concomitant products included RITONAVIR, DOLUTEGRAVIR SODIUM (TIVICAY) and DARUNAVIR ETHANOLATE (PREZISTA) for HIV disease, AMLODIPINE BESYLATE, ACYCLOVIR [ACICLOVIR], PRAVASTATIN, FINASTERIDE, ABACAVIR SULFATE (ZIAGEN) and MORPHINE SULFATE (MORPHINE SULPHATE) 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 09-Apr-2021 at 10:30 AM, 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 POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced WEIGHT DECREASED (lost 20 pounds of his body in the next 24 hours,weight was 184/185) and NIGHT SWEATS (sweat really bad/terrible night sweats). On 17-May-2021, the patient experienced ANGINA PECTORIS (heart attack-like pain) (seriousness criterion medically significant). On an unknown date, the patient experienced SOMNOLENCE (slept a lot after the shot), INFLUENZA LIKE ILLNESS (covid like flu symptoms), ASTHENIA (very weak/very weak feeling), RENAL PAIN (I had pain which I felt like was in the right kidney and lower right abdominal area), ABDOMINAL PAIN LOWER (I had pain which I felt like was in the right kidney and lower right abdominal area), DIARRHOEA (terrible diarrhea), DECREASED APPETITE (Zero appetite now for 3 days although eating once a day), INSOMNIA (no longer able to sleep at night), CHEST PAIN (pain in my heart/pain moved from left side heart area and slid toward my left side), LYMPHADENOPATHY (neck glands swelled last week/2swollen neck glands), FATIGUE (very tired/very fatigue), HEADACHE (Bad headache) and CHILLS (chills (no fever)). The patient was hospitalized from 09-Apr-2021 to 14-Apr-2021 due to POLYURIA. On 10-Apr-2021, POLYURIA (started urinate and couldn't stopped, constant 4 times per hour for the next 30 hours/Can't stopped urination) had resolved. At the time of the report, ANGINA PECTORIS (heart attack-like pain) had not resolved, WEIGHT DECREASED (lost 20 pounds of his body in the next 24 hours,weight was 184/185), NIGHT SWEATS (sweat really bad/terrible night sweats), SOMNOLENCE (slept a lot after the shot), INFLUENZA LIKE ILLNESS (covid like flu symptoms), ASTHENIA (very weak/very weak feeling), DIARRHOEA (terrible diarrhea), DECREASED APPETITE (Zero appetite now for 3 days although eating once a day), INSOMNIA (no longer able to sleep at night), CHEST PAIN (pain in my heart/pain moved from left side heart area and slid toward my left side), LYMPHADENOPATHY (neck glands swelled last week/2swollen neck glands), FATIGUE (very tired/very fatigue), HEADACHE (Bad headache) and CHILLS (chills (no fever)) outcome was unknown and RENAL PAIN (I had pain which I felt like was in the right kidney and lower right abdominal area) and ABDOMINAL PAIN LOWER (I had pain which I felt like was in the right kidney and lower right abdominal area) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) Positive. On an unknown date, Blood creatine: high (High) high. On an unknown date, Electrocardiogram: unknown (Inconclusive) unknown. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Concomitant medications included blood pressure medication. Follow-up received on 11-May-2021 included the completed ADR form with significant information about the patient's medical history and new events. Follow-up received on 12-May-2021 included additional details of lower abdominal pain experienced by the patient. The patient reported that he sought medical care from a doctor's office from 09-Apr-2021 to 15-Apr-2021. significant follow-up received on 03-june-2021 This is a report of a 61-years polymorbid male under multiple chronic therapies; who presented various adverse events after receiving the second dose of the product. For the event heart pain/angina pectoris, the patient was not hospitalized. 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. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. This case was linked to MOD-2021-073550 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up included additional details about the adverse event reported in the initial SD of pain right side abdomen. On 03-Jun-2021: Significant follow-up 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. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.
61 2021-06-16 impaired work ability, feeling abnormal, depression Fever, headache, nausea and brain fog. Suppressed energy, mood and stamina. Depression. I am a cycli... Read more
Fever, headache, nausea and brain fog. Suppressed energy, mood and stamina. Depression. I am a cyclist and before this vaccine I was extremely healthy. After my second shot the above listed symptoms were magnified 10 fold plus muscular burning and aching. I missed 6 days of work and to this day I am suffering a huge drop in energy, mood and stamina. I feel foolish for taking this vaccine. Shame on you all.
61 2021-06-18 disturbance in attention, feeling abnormal About 2 weeks after my second vaccine, i got very ill; abdominal issues, sever fatigue followed by s... Read more
About 2 weeks after my second vaccine, i got very ill; abdominal issues, sever fatigue followed by severe sinus congestion which lasted for about 10 days. This has been followed by ongoing severe fatigue, inflammation of my joins, painful movement and walking, brain fog and inability to concentrate. i am still dealing with the debilitating effects 7 weeks out.
61 2021-06-22 feeling abnormal On January 21st he started to get an headache, brain fog, and dizziness. Went to see his doctor the ... Read more
On January 21st he started to get an headache, brain fog, and dizziness. Went to see his doctor the next morning his doctor didnt know what to do so he set him up for an MRI but the results didn't show anything. Seen a Neurologist on January 23rd but all he did was prescribe him with a stronger Effexor.
61 2021-06-22 feeling abnormal The day after the vaccine he started to get an headache, brain fog, and dizziness. He also lost his ... Read more
The day after the vaccine he started to get an headache, brain fog, and dizziness. He also lost his sense of smell and taste. Went to see his doctor stated they increased his Effexor. They tried giving him Atarax but it didn't work also gave him supplements L-theanine 200 ml, Ashwagandha 200ml and Magnesium Glycinate 300ml said it helped a little.
61 2021-06-22 feeling abnormal Pt was vaccinated on 3/31/2021. His long time partner reported that he started feeling a little off ... Read more
Pt was vaccinated on 3/31/2021. His long time partner reported that he started feeling a little off 2 days post vaccination, he thought he had indigestion. Over the next few weeks he began feeling worse especially with exertion. While at work on 4/19/2021 he told his friend that he hadn't been feeling well for 3 weeks. Shortly after reporting this he went into Cardiac arrest. He was transported to Medical Center, where he was pronounced dead. His partner reports he was healthy with the exception of hypertension. She reports he was thin, never smoked, didn't drink alcohol and rarely used marijuana. She reports only a visual autopsy was performed and pt was cremated.
61 2021-06-23 feeling abnormal I had all the typical previously reported symptoms up to the point when getting first injection as m... Read more
I had all the typical previously reported symptoms up to the point when getting first injection as mentioned in print and on the news. Headaches, body aches and some dizziness. They occurred shortly after the injection (within the first 3 days) But, i noticed (just like mentioned in the news now) that about 2 weeks after getting the 1st injection my chest had a odd "pressure" feeling. Like something wasn't right in there. At the time my work was from home that week so it wasn't a problem to just "take it easy" instead of doing anything strenuous. And in a week or so afterwards it went away totally and I felt confident that the 2nd shot would be ok to take. The 2nd shot had less side effects other than some minor dizziness that subsided within the first week totally. The 2nd week did not have the first shots pressure feeling on my chest like my body had adjusted to getting the shot in some way. Since I have gotten both shots though it seems there is the intermittent "dizziness" that doesn't affect my thinking or motor functions in any way. There just seems to be times where I feel "funny" nothing that is adverse or causes driving or walking issues (motor functions). It's just noticeable at times.
61 2021-06-23 insomnia EXTREME shakes, scary I was shaking so much. Weak, couldnt sleep, Extreme sweating. Very fatigued, ... Read more
EXTREME shakes, scary I was shaking so much. Weak, couldnt sleep, Extreme sweating. Very fatigued, arm very sore.
61 2021-06-29 nervousness, feeling abnormal Woke up day after vaccine, thought i had broken ribs, this went on for about 72 hours, then a few da... Read more
Woke up day after vaccine, thought i had broken ribs, this went on for about 72 hours, then a few days of ok and then walking up my 3 stairs to my house, i got dizzy, my eyes went black and white abd squiggly, instantly massive headache, and stomach aches, my bones hurt thruout my torso... ongoing headaches, Tired all the time, my eyes are blurry alot, Very shaky all the time, loss of appitite, brain fog, back aches
61 2021-06-30 insomnia Chills, shaking, tachycardia, headache, weakness, insomnia for about 16 hours after onset
61 2021-07-01 feeling abnormal, memory impairment Day after vaccine, pt had fatigue and ?brain fog? which he attributed to normal vaccine side effect.... Read more
Day after vaccine, pt had fatigue and ?brain fog? which he attributed to normal vaccine side effect. Over the next several days, he did not improve. Reports that people kept asking what was wrong with him as he was having memory issues and word finding difficulty. His symptoms persisted through 6/9, when first eval for sympotms in my office
61 2021-07-10 suicidal thoughts, anxiety Migraine headaches; Increased anxiety; Muscle stiffness; Pre-vaccine walked 4-5 miles daily and now ... Read more
Migraine headaches; Increased anxiety; Muscle stiffness; Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile; Rash in the genital area which comes and goes; Tenderness and swelling of the injection site and underarm glands; Tenderness and swelling of the injection site; Tenderness and swelling of underarm glands; Muscle ache; Joint aches; Vomiting; Nausea; Fatigue(tiredness); Chills; Suicidal thoughts; Loss of smell; Loss of taste; Loss of appetite; 22 pound weight loss; Arm pain; This spontaneous case was reported by a patient and describes the occurrence of SUICIDAL IDEATION (Suicidal thoughts) in a 61-year-old male 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 Bipolar disorder. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 SUICIDAL IDEATION (Suicidal thoughts) (seriousness criterion medically significant), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), WEIGHT DECREASED (22 pound weight loss), PAIN IN EXTREMITY (Arm pain), MIGRAINE (Migraine headaches), ANXIETY (Increased anxiety), MUSCULOSKELETAL STIFFNESS (Muscle stiffness ), GAIT DISTURBANCE (Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile), RASH (Rash in the genital area which comes and goes), VACCINATION SITE SWELLING (Tenderness and swelling of the injection site and underarm glands), VACCINATION SITE PAIN (Tenderness and swelling of the injection site), LYMPHADENOPATHY (Tenderness and swelling of underarm glands), MYALGIA (Muscle ache), ARTHRALGIA (Joint aches), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Fatigue(tiredness)) and CHILLS (Chills). At the time of the report, SUICIDAL IDEATION (Suicidal thoughts), WEIGHT DECREASED (22 pound weight loss), ANXIETY (Increased anxiety), MUSCULOSKELETAL STIFFNESS (Muscle stiffness ), GAIT DISTURBANCE (Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile), RASH (Rash in the genital area which comes and goes), VACCINATION SITE SWELLING (Tenderness and swelling of the injection site and underarm glands), VACCINATION SITE PAIN (Tenderness and swelling of the injection site), LYMPHADENOPATHY (Tenderness and swelling of underarm glands), MYALGIA (Muscle ache), ARTHRALGIA (Joint aches), VOMITING (Vomiting), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown, ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), MIGRAINE (Migraine headaches) and FATIGUE (Fatigue(tiredness)) had not resolved and PAIN IN EXTREMITY (Arm pain) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Patient reported that the adverse events started immediately after the first shot. Increased anxiety and suicidal thoughts required increasing the dosage of a benzodiazepine. 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 patient´s medical hystory of bipolas disorder could be a confounder for the events, suicidal ideation and anxiety. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Added current condition bipolar disorder, added start dates of the 2 doses. Added events suicidal ideation, gait disturbance, rash, anxiety, lymphadenopathy, musculoskeletal stiffness, myalgia, arthralgia, chills, rash, nausea, vomiting, migraine, vaccination site pain, pain in extremity, vaccination site swelling. Verbatim of the events ageusia and anosmia changed to loss of taste and loss of smell respectively. Outcome of the events anosmia, ageusia and decreased appetite changed to not recovered. This case was upgraded from non-serious to serious due to the addition of new event suicidal ideation; 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 patient´s medical hystory of bipolas disorder could be a confounder for the events, suicidal ideation and anxiety.
61 2021-07-11 loss of personal independence in daily activities Fever, Chills, vomiting, headache, swollen arm, lethargic.
61 2021-07-13 hallucination Day of vaccine - I had fatigue and soreness on my arm; then the next morning I had fatigue; everythi... Read more
Day of vaccine - I had fatigue and soreness on my arm; then the next morning I had fatigue; everything - chills, fever, arm soreness, headache. It all lasted about five or six hours. Then five days later, that night, on the 13th, I had fatigue again and on 14th - tired, headache, chills, and in the middle of the night on the 16th - 103 degrees fever, throwing up, hallucinating, chills, muscle weakness and arm soreness ( I still have arm soreness - at the injection site) and my wife had to call 9-1-1 and EMT's took me to hospital and I was hospitalized for four days. Hospital. I am recovering from the medications still but I have recovered from the health event from the vaccine.
61 2021-07-14 disorientation Patient came to the ED with SOB, kidney pain, weight loss, and disoriented. CT scan and MRI showed p... Read more
Patient came to the ED with SOB, kidney pain, weight loss, and disoriented. CT scan and MRI showed portal vein thrombosis. Patient is still inpatient at Hospital. Patient unable to give lot number or date of vaccination.
61 2021-07-17 anxiety Crusted scalp, psoriasis on his chest, neck elbow, kneecap, scalp, encrusted scalp/patient had flare... Read more
Crusted scalp, psoriasis on his chest, neck elbow, kneecap, scalp, encrusted scalp/patient had flare up of psoriasis and rashes all over his scalp; Uncomfortable extreme reaction of psoriasis, doctor diagnosed him with Sebo psoriasis; Red rash; Blister; Scalp felt tightening like someone was pulling on his head; Itching; worry; Entire body swipe out; skin bleeding; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PSORIASIS (Crusted scalp, psoriasis on his chest, neck elbow, kneecap, scalp, encrusted scalp/patient had flare up of psoriasis and rashes all over his scalp) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039821A and 021821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Parapsoriasis (in the past and has been with dermatologist for 10 years.). On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced SKIN EXFOLIATION (Entire body swipe out) and SKIN HAEMORRHAGE (skin bleeding). On 06-Jun-2021, the patient experienced PSORIASIS (Crusted scalp, psoriasis on his chest, neck elbow, kneecap, scalp, encrusted scalp/patient had flare up of psoriasis and rashes all over his scalp) (seriousness criterion medically significant), SEBORRHOEIC DERMATITIS (Uncomfortable extreme reaction of psoriasis, doctor diagnosed him with Sebo psoriasis), RASH ERYTHEMATOUS (Red rash), BLISTER (Blister), PAIN OF SKIN (Scalp felt tightening like someone was pulling on his head), PRURITUS (Itching) and ANXIETY (worry). The patient was treated with HYDROCORTISONE ongoing since an unknown date for Adverse event, at a dose of 2.5 mg; FLUOCINOLONE ACETONIDE ongoing since an unknown date for Adverse event, at a dose of 0.1 %, topical oil; TRIAMCINOLONE ACETONIDE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and SELENIUM SULFIDE (SELSUN BLUE) ongoing since an unknown date for Adverse event, at a dose of 2.5 %. At the time of the report, PSORIASIS (Crusted scalp, psoriasis on his chest, neck elbow, kneecap, scalp, encrusted scalp/patient had flare up of psoriasis and rashes all over his scalp), SEBORRHOEIC DERMATITIS (Uncomfortable extreme reaction of psoriasis, doctor diagnosed him with Sebo psoriasis), RASH ERYTHEMATOUS (Red rash), BLISTER (Blister), PAIN OF SKIN (Scalp felt tightening like someone was pulling on his head), PRURITUS (Itching), SKIN EXFOLIATION (Entire body swipe out), SKIN HAEMORRHAGE (skin bleeding) and ANXIETY (worry) outcome was unknown. No concomitant drugs were 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. Due to the severity, duration and lack of response to treatment the event psoriasis aggravated is considered serious due to medically significant criteria. This case was linked to MOD-2021-207698 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Additional information received on 03-Jun-2021 contains significant Follow-up included updated the reporter's information, relevant medical history, treatment medications and newly added events. On 07-Jun-2021: Additional information received on 07-JUN-201 contains no new information. On 09-Jul-2021: Follow-up received included no new information. On 09-Jul-2021: Additional information received included additional event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Due to the severity, duration and lack of response to treatment the event psoriasis aggravated is considered serious due to medically significant criteria.
61 2021-07-20 excessive sleepiness Developed weakness in legs, needed help with walking, legs got weak like rubber, couldn't hold self ... Read more
Developed weakness in legs, needed help with walking, legs got weak like rubber, couldn't hold self up. ambulance to hospital, next day, could walk again. Was sent home after 3 days with home PT, had return of weakness, slid off bed, couldn't stand up. Was sent to Rehab- 2 weeks, 75% back to baseline and is extremely tired, sleeping easily
61 2021-07-23 loss of personal independence in daily activities, impaired work ability 3 days after Moderna C19 vaccination on 4/23/21 Patient suffered a massive stroke on 04/26/21. He i... Read more
3 days after Moderna C19 vaccination on 4/23/21 Patient suffered a massive stroke on 04/26/21. He is now a hemi-plegic with severe apraxia and aphasia, unable to work, communicate or care for himself. He had no health issues prior to the vaccination. He was in ICU, Intensive care and hospital for 2 months and rehab continues.
61 2021-07-23 poor quality sleep 1) Within 1 minutes left hand went numb, shot in left arm 2) within 5 minutes all hands and feet wen... Read more
1) Within 1 minutes left hand went numb, shot in left arm 2) within 5 minutes all hands and feet went numb 3) within 10 minutes felt dizziness 4) within 30 minutes tongue went numb 5) within 18 hours severe pain left arm, shot site 6) within 18 hours fever and flu like body aches 7) within 18 hours poor sleep 8) within 72 hours rash on right shoulder 9) within 72 hours tinnitus Note, items 2, 8 and 9 remain
61 2021-07-27 sleep disorder Discomfort and soreness at the injection point and left elbow joint about 2 hours after vaccinated. ... Read more
Discomfort and soreness at the injection point and left elbow joint about 2 hours after vaccinated. Similar to my 1st vaccine 4 weeks earlier, except this time my elbow joint had some soreness. The soreness and swelling continued to get worse throughout the day and could not sleep well that night. The following day I woke up with a painful and swollen elbow joint, and still had soreness around the injection point. By the afternoon I could not move or extend my left arm with severe pain. The swelling and pain increased and Advil or ice was not effective in reducing these symptoms. The pain and swelling got so severe and I could no longer tolerate the pain and went to Urgent Care. I continue to experience left elbow joint pain, and now experience similar joint swelling and pain in my ankle and knee. It's not as severe and painful as my left elbow joint. I am making this report now because 2 days ago I started to develop the same symptoms in my right elbow joint and leg/hip joint, and now I can barely walk. The joint pain is severe so I will seek medical treatment today.
62 2021-01-04 sleep disorder, loss of personal independence in daily activities Arm weakness increased each day by post vaccine day 4 arm weak and unable to raise arm, conduct ADLs... Read more
Arm weakness increased each day by post vaccine day 4 arm weak and unable to raise arm, conduct ADLs, painful interrupting sleep. Unable to initiate movement in arm. Use other arm to help move arm. Went to ED on post vaccine day 4. Wbc 12. Crp 4. CT no abscess. Mri on 1/4 shows bursitis. DX SIRVA. Bursa aspirated. Pending cultures. PO MEDROL DOSEPAK.
62 2021-01-08 feeling abnormal CHILLS, FEVER, FATIGUE Narrative: EMPLOYEE REPORTS THAT HE "FELT OFF" AFTER THE VACCINE. BY EVENING ... Read more
CHILLS, FEVER, FATIGUE Narrative: EMPLOYEE REPORTS THAT HE "FELT OFF" AFTER THE VACCINE. BY EVENING HAD DEVELOPED CHILLS, FATGUE, BODY ACHES, AND FEVER WITH TEMP 101-102.8. CONTINUES THIS MORNING WITH FEVER OF 102. NO HISTORY OF COVID TO HIS KNOWLEDGE. HAD NEGATIVE COVID TEST FIRST WEEK OF DECEMBER.
62 2021-01-08 impaired work ability Dizziness, Headache, Myalgia, NauseaVomiting, dehydration, could not eat, runny nose, sore throat-em... Read more
Dizziness, Headache, Myalgia, NauseaVomiting, dehydration, could not eat, runny nose, sore throat-employee reported being off work since the day of her injection Narrative:
62 2021-01-12 feeling abnormal On January 11th, 2021 patient called to report that he will probably not get the second dose of Mode... Read more
On January 11th, 2021 patient called to report that he will probably not get the second dose of Moderna due to side effects he had after he received the first dose of Moderna. He reports that for a week after he had brain fog, ie. couldnt remember common things, he reported that he got a 1/2 dollar size black and blue mark to skin where the injection was given, and reports it is still there two weeks after receiving the injection. He also stated that his arm was very painful after the injection.
62 2021-01-13 nervousness Nausea , Left Arm Pain, Nervous
62 2021-01-14 anxiety, impaired work ability At work 24 hours after vaccine administration - Lip swelling, jaw swelling increased BP - patient h... Read more
At work 24 hours after vaccine administration - Lip swelling, jaw swelling increased BP - patient has anxiety Benadryl and prednisone provided, staff member was sent home from work, PCP called patient advised to rest and monitor swelling - if swelling continued notify physician.
62 2021-01-15 impaired work ability, sleep disorder Started 1/15/21 at 12:30am. Headache, fever (101), Dehydrated, muscle and joint pain (Very Severe) t... Read more
Started 1/15/21 at 12:30am. Headache, fever (101), Dehydrated, muscle and joint pain (Very Severe) throughout entire body. Could not go to work. Took Tylenol (1000mg) at 10am. Could not rest or sleep. Fever and headache end at 3pm 1/15/21? Took another 1000mg Tylenol at 3pm 1/15/21. Muscle and body pains end at 11pm 1/15/21.
62 2021-01-18 feeling abnormal Headache, body aches, joint pain, fever, violent chills, vomiting, fatigue, brain fog
62 2021-01-18 insomnia Pt feeling very nauseous, throwing up, pain in his tummy. very uncomfortable, dry heaving, could not... Read more
Pt feeling very nauseous, throwing up, pain in his tummy. very uncomfortable, dry heaving, could not sleep. for 10 hours now
62 2021-01-20 sleep disorder Shot taken on a tuesday 12:45 Pm. starting around 6 mild pain to injection area, Mild nausea, fatig... Read more
Shot taken on a tuesday 12:45 Pm. starting around 6 mild pain to injection area, Mild nausea, fatigue, dizziness. Disturbed sleep. Joint pain overnight. Took advil during the night and helped immensely. Following day mild dizziness and fatigue, just feeling slightly unwell. Slept 9 hours that night where normally sleep 6-7. Thursday morning back to 85% and by end of day back to normal.
62 2021-01-26 insomnia Dec. 29, 2020 - first Moderna Vaccine dose. On same day I had mild localized injection site sorenes... Read more
Dec. 29, 2020 - first Moderna Vaccine dose. On same day I had mild localized injection site soreness/pain & felt minimally tired. The next day the injection site was a little more sore/panful & I had moderate headache the whole day. The next day I was fine, Jan. 26, 2021- second Moderna Vaccine dose. Six hrs. later the injection site was mildly sore/painful. 12 hrs. after receiving the dose I began to feel body aches, some chills, decreased energy level & did not fall asleep the whole night. The next day I had moderate headache, continued to have some infrequent chills, body aches, decreased energy level & injection site soreness/pain was still mild but had increased from day before.
62 2021-02-02 impaired work ability, hallucination Hallucinations, Myalgia, Fever, per pt: "flu-like symptoms, chills, fever, tiredness and headache". ... Read more
Hallucinations, Myalgia, Fever, per pt: "flu-like symptoms, chills, fever, tiredness and headache". Took 1 day off from work.
62 2021-02-04 disturbance in attention Nausea, Light Headness, Extreme Tiredness, Unable to Concentrate, Tenderness at the Injection Site
62 2021-02-12 confusional state Body Aches and sore arm started 12 hours after vaccine was administered and still continues High Fev... Read more
Body Aches and sore arm started 12 hours after vaccine was administered and still continues High Fever of 103 started 24 hours after vaccine was administered and still continues. Sweating profusely and confusion and chills Difficulty urinating started 12 hours after vaccine was administered and still continues Loss of appetite and fatigue SOB started 24 hours after and continues slightly
62 2021-02-13 anxiety a 62 y/o M who presents with concerns for an allergic reaction to the second dose of the Covid vacc... Read more
a 62 y/o M who presents with concerns for an allergic reaction to the second dose of the Covid vaccine. According to him he got the vaccine around 8:45 AM. He has a history of anaphylactic type reactions with a swelling and urticaria in the past but has not had any symptoms in the last 5 years. He felt sudden onset pit in his stomach, tingling and warm sensations over his face and some chest tightness. He denies all the symptoms currently. He did get medications prior to arrival but states his symptoms were already getting better before he been given anything. He was given epinephrine as well as Benadryl beforehand. He denies any symptoms currently. Denies headache, change in vision, difficulty swallowing, lightheadedness or vertigo, chest pain, sore throat, wheezing, cough, nausea or vomiting, rash, falls or injuries. Denies any recent foreign travel or sick contacts. He did work a full shift yesterday and was coming off a 24-hour shift prior to getting his vaccination. He denies any significant reactions to the first vaccine. Medical Decision Making On initial presentation is an overall well-appearing 62-year-old male who has normal vital signs without fever or tachycardia. He is presenting with concern for allergic reaction of the field to a recent vaccination. The vaccine was given roughly 1 hour prior to arrival. He was given epinephrine intramuscularly as well as IV Benadryl. He states he is currently feeling mildly tired from the Benadryl. He denies any other recurrent symptomatology and feels better. Examination is not concerning for anaphylaxis at this time, no evidence of airway involvement or multisystem involvement. No evidence of local allergic reaction. Low clinical concern for occult infection, metabolic abnormality, ACS or arrhythmia for a cause of his symptoms. He is overall very well-appearing. Labs have been obtained as part of screening for reactions to the vaccination per CDC recommendations including a tryptase and C4 complement. They were drawn over an hour after the vaccine was administered. ECG was within normal limits. After observation patient remained asymptomatic. Did offer steroids, however he wanted to hold off on them as he just got his vaccination which seems appropriate at this time. He was sent home with a new EpiPen. We also gave him follow-up in the allergy clinic. He has any worsening symptoms we do recommend he use the EpiPen as well as call 911. He is understanding. At this point he stable for outpatient management. I did tell him he should expect to feel aches and potentially have inflammatory response to the vaccine, he is understanding of this. Pt was discharged home/self-care. Pt provided strict return precautions, including but not limited to, any worsening symptoms or any new concerning symptoms. Otherwise, Pt instructed to see PCP on an as needed basis.
62 2021-02-16 feeling abnormal, insomnia Intense Injection site pain. Much worse than first does (in left arm). Fever and feelings of overh... Read more
Intense Injection site pain. Much worse than first does (in left arm). Fever and feelings of overheating. Chills to the point of not being able to get warm. Sleeplessness and fatigue. Headache and fogginess. All symptoms occurred overnight while in bed. Arm pain remains as well as headache and fogginess after attempting to sleep for 7 hours.
62 2021-02-22 disturbance in attention, impaired work ability Approximately 18 hours after taking the vaccine I woke up with body aches and chills. I was also sh... Read more
Approximately 18 hours after taking the vaccine I woke up with body aches and chills. I was also short of breath. The chills lasted approximately 3 hours. The body aches were not severe but lasted 24 hours, as did the shortness of breath. I did go to work on the the 18th (the morning after the shot), but had to leave work early because I was too short of breath to stand up for very long and I also had trouble focusing on my work.
62 2021-02-24 insomnia Extreme Sore Deltoid (1st sign progressed over day). The following symptoms started around 9 pm and... Read more
Extreme Sore Deltoid (1st sign progressed over day). The following symptoms started around 9 pm and increased through the night: severe headache, nausea, malaise, other joint pain - especially joints of previous injuries (lifetime), chills, hot flashes, tiredness - though inability to sleep. I needed to take Tylenol through the night which did help with headache. The symptoms were significantly decreased by 6 pm that day (Feb 24th).
62 2021-02-24 insomnia Initially chills fatigue. Ongoing tinnitus and insomnia
62 2021-02-28 feeling abnormal Lt shoulder pain moves across chest , multiple joint pain, sensation he was dying, blood sugars 275-... Read more
Lt shoulder pain moves across chest , multiple joint pain, sensation he was dying, blood sugars 275-280
62 2021-03-02 feeling abnormal Moderna COVID-19 Vaccine EUA 5-10 minutes after receiving the vaccine the following symptoms were ex... Read more
Moderna COVID-19 Vaccine EUA 5-10 minutes after receiving the vaccine the following symptoms were experienced: Dizziness, weakness, brain fog, breathing difficulties, lowered O2 saturation, nausea, elevated BP and elevated / thready pulse. O2 was administered, I was placed in a response room and monitored by staff nurses (RN and LPN's) MD checked on progress. O2 saturation returned to 100% after 15 minutes and an EPI pen was determined to be not required. Walked out of the hospital 2 hours after administration of the vaccine.
62 2021-03-03 sleep disorder 3/3: Woke up with headache that got continuous. Took acetaminophen and alternated with ibuprofen eve... Read more
3/3: Woke up with headache that got continuous. Took acetaminophen and alternated with ibuprofen every 4 hours. Around 2:00pm, uncontrolled shivering due to chills started. By 3:30, had muscle\joint pain in back and began feeling lightheaded. At 5:30, was unsteady on feet, pounding headache, fever of 101.8F and no appetite for dinner. Fell asleep on couch, woke at 7:30 pm, discontinued ibuprofen and acetaminophen, took 500mg Excedrin, fever of 102.8F and went to bed. Uncontrolled shivering resumed around 8:30pm, woke up several times during the night drenched in sweat and took ibuprofen at 4:30 am. Awoke at 8:30 am on 3/4 drenched in sweat again, took hot shower, had light breakfast and took 500mg Excedrin. Temperature is currently 99.3F
62 2021-03-09 excessive sleepiness I had chills and sweat the bed the first night which was a Sat. Was exrtremly achy all over. Next... Read more
I had chills and sweat the bed the first night which was a Sat. Was exrtremly achy all over. Next day was again extremely achy and that night i went to bed right after supper and slept 12 hours, Again very achy and again sweat the bed all night and woke up on Monday just fine. Aches are gone but have continued to sweat the bed each night. Not dramatically but just slightly these past 2 nights
62 2021-03-09 mental status changes hospitalization for cough, fever and acute change in mental status
62 2021-03-10 feeling abnormal I started feeling bad on Tuesday the ninth at 8 PM fever sweating chilling severe headache joint pai... Read more
I started feeling bad on Tuesday the ninth at 8 PM fever sweating chilling severe headache joint pain and I didn?t start feeling Little better until Thursday The 11th at 10 AM but still having spells where I?m sweating and chilling I went to bed At 8 PM on Tuesday the ninth and did not get up until 10 AM on Thursday the 11th
62 2021-03-11 feeling abnormal I had the Covid virus early in November 2020 I had a bad reaction to my 1st Covid shot and wanted to... Read more
I had the Covid virus early in November 2020 I had a bad reaction to my 1st Covid shot and wanted to ask if I should get the second one? I was able to get an appointment for a Covid vaccination thru store/pharmacy. I had the shot about 4:00 on Friday. On Saturday about noon I started not to feel right; head ache and stomach. About 4:00 I started to get an increase in my temperature. At 5:30 I started getting uncontrollable shaking. Over a span of about 30 minutes I had 4 or 5 episodes that lasted 30 - 45 seconds. I had a temperature at one point that reached 102.3 I took 200 mg of Ibuprofen every three hours before falling asleep for the night. On Sunday morning I still had a slight temperature (99.9), but it seemed like all my body joints ached. I ended up feeling better about 4:00 on Sunday. Reply
62 2021-03-18 impaired work ability Extreme fatigue, was unable to go to work day after vaccination. Lasted 12 hours.
62 2021-03-20 feeling abnormal, sleep disorder ,body aches,shortness of breath,pain and fog in brain, entire bone and joints shooting with pain cou... Read more
,body aches,shortness of breath,pain and fog in brain, entire bone and joints shooting with pain couldn't sleep for,2 days, dizziness,etc etc
62 2021-03-24 excessive sleepiness Flu symptoms fever akes fatigue Tylenol and sleep day after shot
62 2021-03-28 agitation Right at the time of the injection I felt sick ,then muscle spasms started and have not stoped and ... Read more
Right at the time of the injection I felt sick ,then muscle spasms started and have not stoped and on day 5 sense injection ,the next morning supper tired and my eyesight was scattered I could not focus on anything ,very agitated ,thought I was going blind ,had inflamed joints bad pain ,had pain in abdomen possibly liver ,by the 3rd day I regret ever allowing this into my body ,I was feeling fine up until this injection ,and Im very reluctant to get the second shot ,Im afraid it will be even worse ,
62 2021-03-28 feeling abnormal major vertigo attack. Dizziness and fog for 6 weeks after. Skipped second dose. Very bad reaction in... Read more
major vertigo attack. Dizziness and fog for 6 weeks after. Skipped second dose. Very bad reaction in that I still cant funciton at 100%....still dizzy,
62 2021-03-29 sleep disorder Following 1st dose of vaccine, patient developed skin rash on 2nd day, mild maculopapular rash on an... Read more
Following 1st dose of vaccine, patient developed skin rash on 2nd day, mild maculopapular rash on anterior chest - persisted. Following 2nd dose of vaccine, developed skin rash involving anterior chest and lower back ~ 7 days after the vaccine. Rash is pruritic, painful, raised. No fevers/chills/sweats. No oral/ophtho lesions. Still getting worse. Unable to sleep last night due to itching/pain.
62 2021-03-30 sleep disorder I had the usual symptoms, but one symptom I don't see anywhere. Usual: Sore vaccine site, body ach... Read more
I had the usual symptoms, but one symptom I don't see anywhere. Usual: Sore vaccine site, body aches and pains, headache, tiredness. I was unable to sleep due to the symptoms the first night. I convalesced the entire next day and tired easily for the next two days after that. Here's the unusual side affect: I had uncontrollable and very painful leg cramps, that I could not relax. I had to take a muscle relaxer. That was the night of the second vaccine. The cramps were abated thereafter. I am reporting them because I saw them as a side effect no where online.
62 2021-03-31 sleep disorder Awoke between 2am and 3am with chills and fever of 99.9f. The chills lasted about 15 minutes. I awok... Read more
Awoke between 2am and 3am with chills and fever of 99.9f. The chills lasted about 15 minutes. I awoke two more times during the night with chills also. The fever persisted until about 5pm that evening. However, there were no more chills. I also had injection site soreness for about 36 hours.
62 2021-04-02 feeling abnormal Chills / muscle aches / headache / Brain fog / exacerbated MS in many form - Gait - balance
62 2021-04-06 anxiety Intermittent muscular aches, increased anxiety, increased fatigue
62 2021-04-08 loss of personal independence in daily activities Moderna COVID-19 Vaccine EUA, On 04/06/2021 started having pain on middle back (right), it was mi... Read more
Moderna COVID-19 Vaccine EUA, On 04/06/2021 started having pain on middle back (right), it was mild, 04/07/2021 the pain was escalated but can I move around. Then on 04/08/2021, it was very painful on my middle back (right), I cannot move or do anything. Today 04/09/2021, the pain is low and I can do normal activities at home. I took Aleve for pain relieve.
62 2021-04-10 insomnia Unable to sleep due to pain in right arm, chills, adjusted heat to try to sleep but that didn't work... Read more
Unable to sleep due to pain in right arm, chills, adjusted heat to try to sleep but that didn't work. Decided to take hot shower but that caused me to vomit several times. Once I stopped vomiting I started to feel better.
62 2021-04-10 sleep disorder Sore left arm for two days, headaches, sore joints, fatigue, listlessness, sleep disruption
62 2021-04-11 insomnia About 14 hours after I received my second injection of the Moderna vaccine, I woke up feeling a litt... Read more
About 14 hours after I received my second injection of the Moderna vaccine, I woke up feeling a little feverish and quite achy all over. I felt worse over the next hour or so, got out of bed and stayed up for about four hours, feeling chills, headache and the body aches (which centered on my bad back). I took half of one of my pain pills (acetaminophen and oxycodone), and half of a Acetaminophen p.m., and I dozed off for an hour or so. When I awoke from my short nap, I felt better - just exhausted from lack of sleep. The entire episode of side effects lasted only about six/seven hours, throughout the overnight. After that, I was only tired. the rest of that day. Thanks for all you are doing for so many of us out here who believe deeply in science and medicine. Stay safe!
62 2021-04-12 sleep disorder No immediate ill effects after this second shot of the Moderna vaccine at 10 am. Worked that day and... Read more
No immediate ill effects after this second shot of the Moderna vaccine at 10 am. Worked that day and went home, woke up around 2 am with sweats and nausea and headache which became progressively worse through the day prohibiting any activity. Dry heaves and severe headache with dizziness lasted until 4 pm or so. I did take Ondansetron at 12 noon to limit nausea. Worked the following day with few physical symptoms but very irritable. The next day (Saturday) woke with headache and slight nausea which became worse as the day wore on, limiting activity but I was able to get chores done, though I was very lethargic. The next day was much better. Worked on Monday the 12th of April and felt well. Fell ill again with similar but less severe symptoms, though marked nausea and dry heaving again. Slept until approximately 2pm and started writing this report. 4/13/2021
62 2021-04-13 feeling abnormal, amnesia Received the vaccine Saturday am 3/20/2021. Saturday pm had numbness in right foot that lasted a fe... Read more
Received the vaccine Saturday am 3/20/2021. Saturday pm had numbness in right foot that lasted a few minutes. Headache off and on started Sunday 3/21/2021. No medication taken for headache. On Tuesday evening 3/23/2021, driving home from work had a sensation of something being wrong. After arriving home at 7 pm had a short term memory loss. Could not remember details of the day, for instance, or that he'd already had the Moderna shot three days prior. Was driven to the emergency room at about 9:30 pm. Memory gradually improved over the hours following the spell. They kept him in hospital until 3/25/2021, doing tests to rule out stroke, seizure, brain tumor etc. All tests came back negative. Was diagnosed with Transient Global Amnesia.
62 2021-04-13 feeling abnormal Patient woke up the morning of 04/13/21 and explained to his wife that he felt "foggy" mentally. He ... Read more
Patient woke up the morning of 04/13/21 and explained to his wife that he felt "foggy" mentally. He went about his morning chores on the farm. He came inside to sit in his recliner with his feet elevated for almost an hour. At approximately 9:40 am, his wife observed that patient suddenly stiffened without warning and cried out. His arms stretched over his head in the chair and his legs stiffened like a board. His body was visibly contracted. He continued to cry out. His eyes were closed, he was salivating, and his forehead was sweating. His wife watched him move his arms suddenly to his lap, however, his fists were clenched tight. She tried to get his attention by calling to him. She noticed his lips were turning blue. She continued shaking him, shouting and then slapped him. Patient did not respond. She called 911. After 7 minutes, he finally relaxed some and started snoring loudly in the chair. He continued sleeping soundly for about 10 minutes while she waited for EMS to arrive. The wife did elevate his head , as she was told by 911 to do so. She was not able to wake him up during this time period. When the EMS arrived, he was just starting to move. They got him up to stand and he was able to verbalize his need to go to the restroom. They arrived at the hospital at approximately 10:25 am and was released after testing at approximately 2:30 pm.
62 2021-04-15 disturbance in attention I had a (first ever) stroke. I was attempting to take Flecainide for atrial fibrillation to reduce p... Read more
I had a (first ever) stroke. I was attempting to take Flecainide for atrial fibrillation to reduce palpitations, the week prior and during the day of the stroke. I tried to take Flecainide twice before in the past few months, but I was unable to tolerate it. When I had the stroke, I didn't realize I was having one since I'm in very good health. I emailed my electro-cardiologist about my symptoms that day and found it difficult to use the appropriate words and reading the email later, I could see a number of mistakes. My ability to comprehend spoken language that day was impaired. I could only keep a few sentences in my head at a time and my attention span was poor as well, like having significant ADHD, which I don't have. I was unable to retain simple amounts of information the day of the stroke. I didn't seek treatment on the day of the stroke since I felt it was more of the side effects I had been experiencing from Flecainide. After going to the hospital I felt good and much improved, cognitively. An ER neurologist said that my stroke was a 2 on a scale of 1 to 42. Over the remainder of March and until this day (April 16, 2021), I have made steady and rapid improvement. I attribute my recovery to the lower level of stroke damage and the fact that I worked out every day with physical exercise and I worked out cognitively by doing a series of activities that I chose myself: reading out loud, reciting poetry and tongue twisters, playing logic and puzzle games on the PC, returning to my writing tasks for work, practicing grammar, and speaking at length with family and friends as a way to practice speaking. I had one appointment with an occupational therapist and two appointments with a speech therapist and have completed assessment. I now feel I am nearly completely recovered with an odd sense of some improvement in certain areas such as heightened mood and quicker connections for noticing practical matters.
62 2021-04-15 feeling abnormal major stroke; cannot speak; cannot move his arms; declining quickly; This spontaneous case was repor... Read more
major stroke; cannot speak; cannot move his arms; declining quickly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (major stroke) in a 62-year-old male 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 effect. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (major stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced SPEECH DISORDER (cannot speak), MOVEMENT DISORDER (cannot move his arms) and FEELING ABNORMAL (declining quickly). At the time of the report, CEREBROVASCULAR ACCIDENT (major stroke), SPEECH DISORDER (cannot speak), MOVEMENT DISORDER (cannot move his arms) and FEELING ABNORMAL (declining quickly) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment information were not reported. The patient was now in intensive care at the Hospital of Bay City in Michigan and he was declining quickly. Company comment:Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of cerebrovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of cerebrovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.
62 2021-04-15 insomnia Shot given at 9 am. Chills, body aches, headache, and 100.6 fever started at 9 pm. Temp went up to 1... Read more
Shot given at 9 am. Chills, body aches, headache, and 100.6 fever started at 9 pm. Temp went up to 101.6 at 10 pm. Chills stopped about midnight, headache persisted, temp dropped to 100.6. Did not sleep well. The next morning about 6 am, temp dropped to 99.9, headache persisted. Temp normal 24 hours after shot, headache went away, body aches subsided. Never took any pain medication, though I knew I could. I do take excedrin migraine about 5x per week normally. Was happy about side effects as it confirmed my immune system strong. Symptoms tolerable and subsided after about 24 hours. Spent most of day after shot in bed. Arm did not get that sore (Shingles shot 2 much worse). All side effects gone after 48 hours. Glad I resisted temptation to take pain meds though I know it would have been ok to take after shot. No side effects after Moderna shot 1, except for a sore arm.
62 2021-04-16 impaired work ability Several days prior to the shot, I had been experiencing sore, muscle-related pain in my neck, especi... Read more
Several days prior to the shot, I had been experiencing sore, muscle-related pain in my neck, especially the left side and shoulder area, making it difficult to turn my head to the left. I was still experiencing this pain at the time of the shot. The evening of receiving the shot, I awoke at about 11:30 p.m. with extreme pain in my left shoulder (would describe as 8 on scale of 1 to 10)...not sure I could even get out of bed. Was able to "walk it off" and went back to bed, but had the same pain and difficulty getting out of bed twice more that night. Once prone, the pain would eventually subside. Went to work that morning (the day after receiving the shot) but returned home after an hour as I had a mild fever (100.1) and chills. I took 2 Ibuprofen and slept for about 2 hours. I awoke with temperature down to 99.7 and less pain in the left shoulder/arm area. Throughout the day, my temperature continued to go down and the chills lessened. Two days later, I have no fever and mild pain at injection site.
62 2021-04-16 mental status changes, confusional state he received Moderna vaccine on 03/15/2021 and on 04/13/2021. On the day following his second dose... Read more
he received Moderna vaccine on 03/15/2021 and on 04/13/2021. On the day following his second dose of vaccine, he awoke fever up to 103, chills, and confusion, so wife called 911. Per neurology consult 4/15 - "... he got his COVID vaccine Tuesday (one day before admission), and since then he's felt warm and shaking. Jaw has had abnormal movements and clenching, upper extremities have had random, non-rhythmic, jerks. Not rhythmic shaking. Not tremor. Just jerks. Worse when he goes to grab something. He's also having some altered mentation, mild confusion, though he can talk, he sounds confused and cannot find all of his words." Tm 103.4. On exam 4/15 one day after admission, He had upper motor neuron irritability signs, 3+ reflexes, myotonic jerks, new action tremor, jaw pain from constant jaw movements. + headache. Keppra and / or mirapex, then ativan later, seemed to help. Symptoms had completely resolved by 4/16/21.
62 2021-04-16 sleep disorder Right hip pain lead to sciatica like nerve pain. Using ice and lidocaine to reduce pain. Severe, re... Read more
Right hip pain lead to sciatica like nerve pain. Using ice and lidocaine to reduce pain. Severe, recurring nasal discharge and minor amount of sneezing first night after shot. After the discharge ended after a few hours I felt that my (prevaccine) sinus infection congestion in upper sinuses actually got better. I have taken a lot of prednisone for chronic sinusitis and asthma and after the vaccine (espec first night and second day) I felt similar (unable to sleep--jittery--flushed). Slight fever that never exceeded 100 degrees first night and second day. Normal temperature 48 hours later.
62 2021-04-17 amnesia The following morning developed rapid onset of memory loss. Transported to ER, urgent ct performed w... Read more
The following morning developed rapid onset of memory loss. Transported to ER, urgent ct performed with contrast. No findings and diagnosed with Transient Global Amnesia Resolved within 4 hours
62 2021-04-18 confusional state Had a severe adverse reaction to Moderna Covid vaccine, 2nd shot. Admitted into the hospital due to ... Read more
Had a severe adverse reaction to Moderna Covid vaccine, 2nd shot. Admitted into the hospital due to confusion, fever and loss of cognitive impairment. (unable to walk and speak) speech was out of context) and loss of muscle use and fever.
62 2021-04-21 confusional state Initial presenting symptoms upon awakening four days after his shot were muscle spasms, "felt things... Read more
Initial presenting symptoms upon awakening four days after his shot were muscle spasms, "felt things in his chest," and dark urine. Within 48 he was confused and was unable to state his last name, which progressed to unresponsiveness by ~7 days after the vaccine. He has since become comatose and his brain MRI is notable for hyperintensity involving the deep gray nuclei as well as the periventricular and subcortical white matter diffusely, bilaterally. The etiology of his comatose state is still under investigation, but a detailed infectious, autoimmune, and malignancy work up at 2 different medical centers and have since been unrevealing as to alternate causes.
62 2021-04-21 excessive sleepiness My arm was very sore to the touch and hurt to move. I developed symtoms like a bad flu withou chest ... Read more
My arm was very sore to the touch and hurt to move. I developed symtoms like a bad flu withou chest and nasal symptoms. I had a bad headache. Severe fatigue and body aches. Ran a temp of 99.1 for about 12 hours. Took no reducers. From the night of the shot to mid-day (48 hours later) I slept 30 hours. I woke up to use the restroom. I drank a lot of water. After 48 hours and all that sleep and water, I felt better. A little fatigue for a couple of days more.
62 2021-04-22 hallucination 1) After midnight, I began to get what felt like the shivers, but they were unlike anything I had ev... Read more
1) After midnight, I began to get what felt like the shivers, but they were unlike anything I had ever seen or experienced, as I could not stop shaking, feeling like I had to try to get warm. I had a heat pack under my back, and no temperature, but for 25 minutes, kept shaking. 2) At 10am in the morning, I began hallucinating, which has never happened to me before, and I only recognize because when my Dad was dying of prostate cancer, they had him on morphine and he began to see things. It was a very specific hallucination, of being in a specific from in front of a specific computer talking to a person. I feel quite reluctant to share this. This lasted for somewhere between 30 and 45 minutes. 3) I've vomited once, and had diarrhea, drinking lots of water, and only using Tylenol. I did not take the Tylenol until after I stopped shivering.
62 2021-04-22 impaired work ability He got the vaccine, had a little pinch, did not bother him. Then it got a little sore and went away... Read more
He got the vaccine, had a little pinch, did not bother him. Then it got a little sore and went away. A day or two later things would show up, got fatigued, headache seemed to be the main thing, nausea without vomiting, chills and no fever. The symptoms are moving around the body with body aches. This morning when he got up he was very nauseated, and not feeling well. Did not go to work as not knowing if he had the flu or anything else.
62 2021-04-25 anxiety, sleep disorder I have anxiety, rapid heart beat especially when waking up unable to sleep, chest pain, higher blood... Read more
I have anxiety, rapid heart beat especially when waking up unable to sleep, chest pain, higher blood pressure, a little dizziness and weakness.
62 2021-04-25 insomnia Insomnia, Aching Joints / Muscles, low grade fever
62 2021-04-27 feeling abnormal Bleeding Gums, Rash, fatigued, shortness of breath, random joint pain, fever, chills, brain fog, el... Read more
Bleeding Gums, Rash, fatigued, shortness of breath, random joint pain, fever, chills, brain fog, electric shock in arms, left arm weakness. 2 emergency rooms, 1 walk in medical center, 1 doctor visit, cardiologist, rheumatologist. Extensive blood work at both ER's and Doctors, x-rays, EXG, cat scan. Yesterday received cortisone shot left arm. Presently on prednisone 2o mg 2x, hydroxyzine 25mg 2x bed, gabapentin 100 mgg 3x.
62 2021-04-27 insomnia Weakness (whole body), Voice changing, Sleeplessness, Rib cage hurts since 4/11/2021
62 2021-04-27 loss of personal independence in daily activities It started with pain in my right shoulder then it became my boss shoulders it's similar to having a ... Read more
It started with pain in my right shoulder then it became my boss shoulders it's similar to having a rheumatism then it'll be after the second shot it became severe pain in my bows shoulder joints and the muscles around them I can't lift my arms above my shoulders I cannot use my hands to do anything for more than 30 seconds then severe pain will start
62 2021-04-30 feeling abnormal, hallucination hallucinating; full day spent in bed feeling bad; chills; Body Aches; A little bit of a fever; didn'... Read more
hallucinating; full day spent in bed feeling bad; chills; Body Aches; A little bit of a fever; didn't eat for 2 full days; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinating) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 virus test positive (Patient with a prior, confirmed COVID 19 Infection requiring a ventilator in October and November.) in October 2020. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FASTING (didn't eat for 2 full days), CHILLS (chills), MYALGIA (Body Aches) and PYREXIA (A little bit of a fever). On 23-Apr-2021, the patient experienced FEELING ABNORMAL (full day spent in bed feeling bad). On an unknown date, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant). On 24-Apr-2021, HALLUCINATION (hallucinating), FASTING (didn't eat for 2 full days), FEELING ABNORMAL (full day spent in bed feeling bad), CHILLS (chills), MYALGIA (Body Aches) and PYREXIA (A little bit of a fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient took Blood pressure medicine(Name Not specified) and aspirin as a concomitant medication. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
62 2021-05-02 insomnia Pt reported that he was vaccinated around 2:45 pm and at 6:45 pm the same day began to feel nauseous... Read more
Pt reported that he was vaccinated around 2:45 pm and at 6:45 pm the same day began to feel nauseous and light headed. He states he was so weak he had trouble getting into bed. He also experienced feeling cold and sweaty. He states he took his temperature and did not have a fever. He states he felt a little better around 8:30 pm and ate crackers and soup. He states he didn't sleep well and was still nauseous and felt like he had heartburn around 5 am. He states he was able to eat at 7 am the next morning (3/13) and took a shower around noon. Pt states he took his blood pressure on the morning of 3/13 and that it was low. He says he took his blood pressure daily until the 22nd, and it took about a week for it to return to normal for him. Pt reports that he saw his primary care provider on 3/18/21 and his EKG was normal but his BMP was elevated. PCP referred him to cardiologist.
62 2021-05-04 nervousness 12 hours later he felt nauseated and which he still is as of today. Then last night he threw up and ... Read more
12 hours later he felt nauseated and which he still is as of today. Then last night he threw up and felt shaky today. He is sipping on powerade. Not eating much. Drinks beer still.
62 2021-05-05 sleep disorder Delayed skin response. Blisters on and between fingers and toes and on hands and feet. Isolated area... Read more
Delayed skin response. Blisters on and between fingers and toes and on hands and feet. Isolated areas of red bumps all over body that itched like poison ivy. Extreme itching at night making it difficult to sleep and be comfortable. I went to medical facility after an evening phone conversation. They prescribed an antihistamine and topical lotion. The first days were the worst with the blistering and very itchy small red bumps. After the first few days, improvement occurred each day until about the 10th day when the skin reaction had resolved.
62 2021-05-06 anxiety Respiratory Symptom - Patient had a hard time breathing one hour after his 1st dose of the Moderna ... Read more
Respiratory Symptom - Patient had a hard time breathing one hour after his 1st dose of the Moderna Vaccine. Patient expressed he was feeling some anxiety/panicky also. Patient stated he was short of breath at this time.
62 2021-05-07 impaired work ability, feeling abnormal Bad body aches, Sharp headache, brain fog. Missed the next two days of work.
62 2021-05-08 insomnia Moderna COVID-19 Vaccine EUA. Following first shot, I had really bad joint and muscle pain around jo... Read more
Moderna COVID-19 Vaccine EUA. Following first shot, I had really bad joint and muscle pain around joints. Took hot showers for pain and Tylenol. Pain in right shoulder (where I have something else going on) increased a lot. After the second shot (about 3 days later), joint and muscle pain returned in all joints. Now, May 9th, joint pain is really bad in arms, hips and legs. It is difficult to walk and to raise arms. I haven't slept due to severe pain. I hope this subsides. I will give it a few more days but it's very painful.
62 2021-05-10 anxiety Anxiety, dizziness, sweating
62 2021-05-12 sleep disorder Acute pain in arms, shoulders, upper back, groin, hamstrings, lower buttock. Can hardly stand the pa... Read more
Acute pain in arms, shoulders, upper back, groin, hamstrings, lower buttock. Can hardly stand the pain. Does not allow me to lift arms or stretch legs due to crazy pain. Can hardly lift blankets off me in morning. Movement helps and I loosen up by late afternoon, but the evening tightens me up again. Acute pain ranging to 8 or 9 on a scale of 10. Tried Advil 4x per day. Helped me maintain, but never took pain away. Went to Rheumatology Clinic, took many labs and x-rays. Gave me prednisone. Worked day 1, then back to acute pain that continues to keep me sleepless.
62 2021-05-14 feeling abnormal severe syncope, pt was pale and sweaty and 'felt funny'...administered epipen and pt stated he felt ... Read more
severe syncope, pt was pale and sweaty and 'felt funny'...administered epipen and pt stated he felt better then lost consciousness again and thready pulse...called 911, EMT came, gave oxygen and started infusion, took him to hospital. Pt discharged after several hrs
62 2021-05-15 insomnia, excessive sleepiness 10 hours after the injection, suddenly bad pain at injection site and rising temp. Body started chin... Read more
10 hours after the injection, suddenly bad pain at injection site and rising temp. Body started ching so bad that the soles of my feet hurt when walking. Temp increased during the night with sweats and cold chills. My usual body temperature is around 97 so when it went to 102.2, that is a high fever for me. Didn't sleep much because of all the discomfort. Nose totally clogged up, had to breath trough mouth only. Temp went down to 100.5 by the mroning. Slept all day and untill 5 AM Sunday 5/16. Very sore and took some Advil Saturday late afternoon. Didn't help. Sunday, now at 5:40pm ET, temp has returned to normal, but I am still sore all over and have no energy.
62 2021-05-15 sleep disorder 10 hours after the injection, suddenly bad pain at injection site and rising temp. Body started chin... Read more
10 hours after the injection, suddenly bad pain at injection site and rising temp. Body started ching so bad that the soles of my feet hurt when walking. Temp increased during the night with sweats and cold chills. My usual body temperature is around 97 so when it went to 102.2, that is a high fever for me. Didn't sleep much because of all the discomfort. Nose totally clogged up, had to breath trough mouth only. Temp went down to 100.5 by the mroning. Slept all day and untill 5 AM Sunday 5/16. Very sore and took some Advil Saturday late afternoon. Didn't help. Sunday, now at 5:40pm ET, temp has returned to normal, but I am still sore all over and have no energy. ADDENDUM: TEMP WAS 97.1 THIS MORNING (MY NORMAL TEMP) 97.1 WHICH IS MY NORMAL TEMP AND JUST NOW WENT UP TO 100.2 AT 6PM ET
62 2021-05-18 disturbance in attention reports that the patient called her over and informed her that he was experiencing left head pain an... Read more
reports that the patient called her over and informed her that he was experiencing left head pain and the he had a bump there that was not there before and he just felt after he had received his vaccine (5/19/21 at 1102am)." escorted pt to triage area and stayed with pt until ARNP was able to assist him 3-5 minutes later.reports that pt was unable to concentrate or answer questions appropriately when she spoke with him. pt sitting upright with both arms on knees, appears to be in pain. pt reports the same situation to ARNP as what was reported to. Vitals obtained 1110: 119/76 BP, 75HR, 98%. pt A&OX3, Pt denies a hx of DM2, HTN, and anxiety. Lesion on L forehead was appreciated and was erythematic along with his L cheek. pt denies any previous trauma or bug bites this AM states " I came home, took a shower and then came to get my shot." visual acuity test performed and PERRLA present and pt able to follow without issue. B.F.A.S.T. completed to r/o stroke symptoms and it was negative. Lesion on L side of head continued to grow and pt's L eye visually was closing (or getting smaller). pt then reports that L side of face began to be numb and L arm with pain. he then agreed to be seen at ED; EMS called at 1115. Second set of vitals obtained 121/86 BP, 75 HR, 95%. pt given 2 tabs of benadryl at 1122. EMS arrived at 1130 and pt left with them.
62 2021-06-02 insomnia Beginning the next day after immunization, the patient was unable to sleep for about 14 days.
62 2021-06-03 confusional state Pt had second Moderna Covid shot. On May 18th, One day later started to become confused. I saw ... Read more
Pt had second Moderna Covid shot. On May 18th, One day later started to become confused. I saw him on May 20. He was confused, no headache. He had a large acute left Cerebral ischemic infarct. Three was an overlying 2.6 X 2.2 CM hemorrhagic infarct. Blood pressure was elevated at 170/130, I controlled blood pressure with Cardene drip.
62 2021-06-06 mental status changes Hospital Course: Patient was admitted to the medical floor with altered mental status, placed on emp... Read more
Hospital Course: Patient was admitted to the medical floor with altered mental status, placed on empiric Rocephin/Zithromax for presumptive bacterial pneumonia. It was later revealed that he received his 2nd Moderna COVID19 vaccination on 5/18, having recovered from COVID19 in Dec 2020. This certainly raises the question as to if his symptoms are related to immune-response to the vaccine. He certainly seems to think so, based on timing of his symptoms and being in his usual state of health prior to getting it. Nonetheless, he is being treated initially for presumptive straightforward community acquired pneumonia. Quite unexpectedly, within 24 hours of his abrupt decompensation, he has returned to baseline. Off O2, mental status sharp and at baseline, no further fevers. This rapid improvement confirms suspicion that his presentation is likely adverse effect/immune mediated response to the 2nd COVID vaccine (Moderna). He became acutely ill within 24 hours of vaccine and resolved almost exactly 48 hours afterwards. Creatinine has returned to baseline 1.9-2.0 after IV fluids. Cultures remain negative.
62 2021-06-08 feeling abnormal I had pain in my arm and it was swollen up. I was really tired. I had a headache (low grade), dizzin... Read more
I had pain in my arm and it was swollen up. I was really tired. I had a headache (low grade), dizziness, and an hour or 2 later I started getting chills really bad. The next day I felt dizzy and kind of foggy. I did not take my temperature.
62 2021-06-21 insomnia I experienced immediate chest pain, chills, difficulty sleeping, numbness, dizziness when standing. ... Read more
I experienced immediate chest pain, chills, difficulty sleeping, numbness, dizziness when standing. Vomiting. Occasional elbow pain on left arm.
62 2021-06-23 disorientation, confusional state Patient became disoriented incontinent extremely high blood pressure lethargic exhausted confused... Read more
Patient became disoriented incontinent extremely high blood pressure lethargic exhausted confused jumbled speech
62 2021-06-27 anxiety This is my second report on this. The first report was more about the soreness, tiredness and feeli... Read more
This is my second report on this. The first report was more about the soreness, tiredness and feelings of lethargy. But approximately 2 weeks after the shot I suddenly had high BP. 165/110 taken by nurses where I work. Was taken to doctor. This continued on and off for about 5-7 days. During this time my blood pressure fluctuated for no reason, and i kept having a rapid pulse even after sitting for long time periods- sometimes reaching 90-100 BPM. Symptoms finally relaxed after a week and I felt normal again. I then received the 2nd Covid vaccination on 2/19/21. About 5 days after this the same symptoms occurred. It came on faster and lasted longer. Fluctuating BP again, and high heart rates. Sometimes associated with feelings of anxiety. I did a follow up Doctors appt. and told them what I thought happened, that it was all from the vaccine. It took about 2 weeks to get over this episode where my BP stabilized and my heart rate stay normal -around 70+ BPM. To this day I have sharp heart pains. First lot was Moderna #013L20A. Second Lot was not specified on my card
62 2021-06-28 loss of personal independence in daily activities I received my first Covid 19 Moderna vaccine (lot 001A21A) on 3/5/2021. I received my second Covid 1... Read more
I received my first Covid 19 Moderna vaccine (lot 001A21A) on 3/5/2021. I received my second Covid 19 Moderna vaccine dose (lot 017B21A) on 4/2/2021. On 4/11/2021, I awoke to excruciating, bilateral pain in my hips and shoulders. I could walk only with difficulty and I had trouble dressing myself. This pain persisted for days and, after testing to rule out Lupus and Rheumatoid Arthritis, I saw rhematologist Dr. at Health Center on 5/5/2021. She diagnoses me as suffering from PolyMyalgia Rheumatica and prescribes MethylPrednisolone 16mg. Over the course of a few days, the pain subsided and I remain on this dose of MethylPrednisolone today and continue to see Dr. monthly to track the status of my Polymyalgia Rheumatica. She suggested that I post my experience on VAERS because she has seen some other instances of Polymyalgia Rheumatica proximal to the Covid vaccine.
62 2021-06-30 anxiety Patient reported feeling dizzy, anxious and sweaty at 2:45pm. Patient given a water and observed for... Read more
Patient reported feeling dizzy, anxious and sweaty at 2:45pm. Patient given a water and observed for an extra 15 minutes. Reported feeling better and left at 3:06pm.
62 2021-07-08 disturbance in attention Difficulty concentrating, maintaining train of thought. Somewhat better now but still struggling wit... Read more
Difficulty concentrating, maintaining train of thought. Somewhat better now but still struggling with it almost two months after. Tiredness and exhaustion. Still struggling with it.
62 2021-07-15 feeling abnormal high blood pressure, amloditimeeesylate, head stretching feeling, dizzy spells,
62 2021-07-16 insomnia, loss of personal independence in daily activities Within 2 weeks of my first injection I became experiencing diffuse muscle and joint pain through my ... Read more
Within 2 weeks of my first injection I became experiencing diffuse muscle and joint pain through my shoulders, back, and leg. The pain during the first several weeks was so extreme that I was unable to sleep. I then began experiencing tinnitus. Since that time the tinnitus has persisted and I have severe low back and hip pain. All X-rays from an orthopedic consult have shown mild arthritic changes. I had MRI?s of the hip and lumbar spine 3 days ago and am awaiting the results. My activities have been significantly limited due to pain any the tinnitus has gotten worse. A week of prednisone therapy provided temporary relief of the tinnitus and some relief of hip pain. Both symptoms quickly returned within a day of prednisone being discontinued. Although I have a history of mild hearing loss, I have never had tinnitus before and the low back pain, sciatica, and hip pain were non existent prior to the first dose of the Moderna vaccine. I did have the second dose on April 6, but noticed no changes after that dose.
62 2021-07-17 anxiety, insomnia, feeling abnormal Anxiety directly related and due to the vaccine; I got Insomnia,10 days without sleeping,Lack of sle... Read more
Anxiety directly related and due to the vaccine; I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.; his chest hurt so bad; he got sick very bad; He has elevated immunity; More than 35 days after the first dose without receiving the second dose; I felt like I was having a heart attack; my knees were aching; When I woke up the next day, felt like a truck ran me over; lost all appetite; it attacked both my knees so severely I could hardly walk; Couldn't get off my toilet seat; I can't sit in my couch; had all kind of symptoms; 101 fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (his chest hurt so bad), MYOCARDIAL INFARCTION (I felt like I was having a heart attack), ANXIETY (Anxiety directly related and due to the vaccine) and INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.) in a 62-year-old male 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. No Medical History information was reported. On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Endocervical) at an unspecified dose. On 22-Mar-2021, the patient experienced GENERAL SYMPTOM (had all kind of symptoms), PYREXIA (101 fever) and CHILLS (chills). On 23-Mar-2021, the patient experienced INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.) (seriousness criterion hospitalization), FEELING ABNORMAL (When I woke up the next day, felt like a truck ran me over), DECREASED APPETITE (lost all appetite), GAIT INABILITY (it attacked both my knees so severely I could hardly walk), DYSSTASIA (Couldn't get off my toilet seat), SITTING DISABILITY (I can't sit in my couch) and ARTHRALGIA (my knees were aching). On 06-Apr-2021, the patient experienced CHEST PAIN (his chest hurt so bad) (seriousness criterion hospitalization) and MYOCARDIAL INFARCTION (I felt like I was having a heart attack) (seriousness criterion medically significant). On an unknown date, the patient experienced ANXIETY (Anxiety directly related and due to the vaccine) (seriousness criterion hospitalization), PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose), ILLNESS (he got sick very bad) and IMMUNE SYSTEM DISORDER (He has elevated immunity). The patient was hospitalized from 06-Apr-2021 to 07-Apr-2021 due to CHEST PAIN. At the time of the report, CHEST PAIN (his chest hurt so bad), MYOCARDIAL INFARCTION (I felt like I was having a heart attack), ANXIETY (Anxiety directly related and due to the vaccine), INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.), GENERAL SYMPTOM (had all kind of symptoms), FEELING ABNORMAL (When I woke up the next day, felt like a truck ran me over), DECREASED APPETITE (lost all appetite), GAIT INABILITY (it attacked both my knees so severely I could hardly walk), DYSSTASIA (Couldn't get off my toilet seat), SITTING DISABILITY (I can't sit in my couch), ILLNESS (he got sick very bad), IMMUNE SYSTEM DISORDER (He has elevated immunity), ARTHRALGIA (my knees were aching), PYREXIA (101 fever) and CHILLS (chills) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 101 (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Endocervical) was unknown. Patient reported that he wont get the second one, as he got sick very bad. He had elevated immunity, his antibodies level is off the charts, that was documented in his hospital. Concomitant medications was not reported . Treatment history was not reported . 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.
62 2021-07-20 mental status changes, loss of personal independence in daily activities Suffered an unwitnessed fall this evening ~ 0130. Prior to this he had been ambulating in the dayro... Read more
Suffered an unwitnessed fall this evening ~ 0130. Prior to this he had been ambulating in the dayroom around midnight without difficulty at his baseline and interacting with staff. He then went to his room. During rounds ~0130, the staff found him in the bathroom face down. He stated he lost his balance but was not able to provide more information. He was assisted up and he had difficulty walking . RN noted three abrasions on his forehead and one on his chin. His vitals were 146/86, 20, 74, 97.2. He had a change in his baseline mentation and ambulatory status at that time. Patient transferred to local ED, where he was seen by two providers. At that time, patient was noted to be using his right arm and left.
62 2021-07-22 loss of personal independence in daily activities It's interesting as a non-medical person, the struggle I'm having, to get one person to just underst... Read more
It's interesting as a non-medical person, the struggle I'm having, to get one person to just understand the period of time that I've seen different providers. Since my second injection I had suffered from ongoing problems, I have days where I can just hardly stay awake. I have never felt like there was a single medical professional who was trying to even find out what was going on with me. On May 28th I woke up in the morning at 2:30AM with an extreme case of dizziness and nausea. I got up and went to the bathroom and went back to the bed thinking I could go back to sleep. It was as if I had some type of horrible severe hangover or something, but I did not. About an hour later I got up, fell on the floor, then decided I had to go see somebody. I called the ambulance and was taken to the ER, where they ran lots of tests. The diagnosis was that I had severe peripheral vertigo. and prescribed medications for that. So in June 2021 I went to the DR for a stress test and echocardiogram and those came back fine. I get mild nausea and dizziness still but nothing like had happened originally. I had visited PCP, my DR, after my visit to the ER and she is the only one kind enough to me to care. I have had an ongoing effect on my ability to function so when I got the v-safe check in, of course I replied that I have had an event of course. Ondansetron 8MG as needed for nausea Meclizine 25MG as needed for dizziness, these are the medications they gave me at the ER by the way.
63 2021-01-05 confusional state fever 101-102 on 12/30/2020 with confusion
63 2021-01-05 confusional state fever 101-102 on 12/30/2020 followed by confusion, headaches
63 2021-01-06 sleep disorder One week after the vaccination, sudden onset of severe itching at the site, with a raised red bump a... Read more
One week after the vaccination, sudden onset of severe itching at the site, with a raised red bump at site of needle puncture. The itching is severe, bad enough to prevent sleep, and there is redness around the injection site followed by burning pain. It has been a day since the itching started, and it has not let up.
63 2021-01-12 impaired work ability Myalgia, Arthralgia, Fever, ErythemaMultiform, UrticariaPruritus, NauseaVomiting, Fatigue Narrative:... Read more
Myalgia, Arthralgia, Fever, ErythemaMultiform, UrticariaPruritus, NauseaVomiting, Fatigue Narrative: Lost time of work
63 2021-01-18 delirium Hypotension, Prolonged seizure with bowel incontinence, cough, weakness and delirium, resulting in 9... Read more
Hypotension, Prolonged seizure with bowel incontinence, cough, weakness and delirium, resulting in 911 transport and admission to hospital for intubation and mechanical ventilation for acute respiratory hypoxia.
63 2021-01-21 feeling abnormal At the end of patient's monitoring after the covid-19 vaccine, patient said he felt like his heart r... Read more
At the end of patient's monitoring after the covid-19 vaccine, patient said he felt like his heart rate was fast subjective feeling. Medical provider and nurse assessed patient. Patient had normal heart rate 60-64 rate, regular rate and rhythm on exam, normal sao2 94-95%, elevated blood pressure 153/103, 174/92, 160/109, 153/93, 170/86.
63 2021-01-24 feeling abnormal On Saturday 01/23/2021 morning when I got out of bed I experienced difficulty maintaining my balance... Read more
On Saturday 01/23/2021 morning when I got out of bed I experienced difficulty maintaining my balance. I had to use a wall to be able to stand. I did not fall. I stumbled into the bathroom, still unsteady. I urinated sitting down, still feeling unsteady, head spinning. I took my blood pressure 130/70, which is normal. Was feeling steadier. Was able to walk down stairs to ground floor of home. Still not felling normal, but steady on my feet. After eating breakfast, no additional symptoms through day. I had not consumed any alcoholic beverages over the past week. When I went to bed Sat night, lying in bed I was light headed. Sunday morning same problems. I performed some vehicle maintenance and would get down on the ground. Head would start spinning, everything would return to normal once standing. At bedtime same feelings when lying down in bed. Monday morning (today) same problems.
63 2021-02-01 impaired work ability Began experiencing severe chills, headache, joint ache, fatigue, muscle ache, fever 12 hours after i... Read more
Began experiencing severe chills, headache, joint ache, fatigue, muscle ache, fever 12 hours after injection. Symptoms continued for additional 48 hours. Unable to report to work for that time.
63 2021-02-04 insomnia Trouble falling asleep night of vaccine, headache, nausea,,dizzy, off balance (slight).
63 2021-02-07 disturbance in attention, memory impairment, confusional state 2/5/.21 @ 1:00 PM visited my Primary Care DR: he did a physical evaluation and provided guidance on ... Read more
2/5/.21 @ 1:00 PM visited my Primary Care DR: he did a physical evaluation and provided guidance on the signs of Stroke "FAST" Patient Issues: Physical shaking like Parkinsons , Heart Palpitations and rapid BPM, Chest Pressure, shallow breathing, stuttered speech, Slurred Speech, Headaches, Confusion and lack of short term recall, red flush face, difficulty in comprehending conversations, reading
63 2021-02-17 feeling abnormal, insomnia Severe arm ache at injection site. Headache. Slight Fever Tired Could not sleep General poor feeli... Read more
Severe arm ache at injection site. Headache. Slight Fever Tired Could not sleep General poor feeling All took place early morning right after shot
63 2021-02-17 feeling abnormal Passed away; tired; nonresponsive; cold; difficulty breathing; swelling; sore arm; feeling weird and... Read more
Passed away; tired; nonresponsive; cold; difficulty breathing; swelling; sore arm; feeling weird and funny; A spontaneous report (United States) was received from a consumer concerning a 63 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal and the patient passed away . Medical history included treatment for tuberculosis and dialysis. Concomitant medication included calcium acetate, Renvela, glipizide, omeprazole, aspirin, vitamin D, losartan, furosemide, rifampin, and Sensipar. On 14 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 030L20A) for prophylaxis of COVID-19 infection. On 13 Jan2021, the patient tested negative for COVID-19). On 16 Jan 2021, the patient experienced a sore arm, and feeling weird/funny. On 17Jan2021, the patient experienced difficulty breathing and swelling. On 18 Jan 2021, the patient declined dialysis, was tired and wanted to lay down. At 8 am, the patient was found nonresponsive and cold and is believed to have passed away around 4 am. The coroner tested the deceased for COVID-19 and the test was positive. No autopsy was reported. No death certificate was issued at the time of the report but the reporter believes it will list cause of death as COVID complications. Action taken with the mRNA-1273 was not applicable. The outcome of the events of limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal, was fatal. On 18 Jan 2021, the patient was died. Cause of death was COVID-19. Autopsy details were not provided.; Reporter's Comments: The events developed on four days after first dose of mRNA-1372. Dyspnea, unresponsive to stimuli, and death were consistent with infection in pandemic set up confounded by age of patient and refusal of dialysis Cause of death was reported as COVID-19. Autopsy details were not provided. Based on reporter's causality the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: COVID-19
63 2021-02-22 nervousness Feel cold, shaky. I got warm clothes and not cold anymore but very fatigue.
63 2021-02-23 sleep disorder I had a nasty reaction to 2nd dose of Moderna 8-12 hours after. Began with body aches and chills so ... Read more
I had a nasty reaction to 2nd dose of Moderna 8-12 hours after. Began with body aches and chills so severe it was hard to breath. No fever. When I got under covers and warmed up so chills subsided and breathing returned to normal it felt like I was being squashed in a Panini press. Every cell in my body felt like it was vibrating in pain. I had to get up ever hour or so to urinate. I would be back in sever chill mode before i made it to the bathroom and it took about 5 minutes back in bed for chills to stop and breathing back to normal. I was also nauseous the whole time but did not vomit Then. The room temperature was 72F. This continued for 12-14 hrs. I then tried to drink cranberry juice and eat 3 bites of a banana which I immediately regurgitated. The rest of the day I was drained of energy. No sleep 48hrs. 3 days
63 2021-02-28 sleep disorder, irritability I have been having muscle spasms, uncontrollable jerking and shaking, mostly when I'm at rest. I'm a... Read more
I have been having muscle spasms, uncontrollable jerking and shaking, mostly when I'm at rest. I'm also getting a little tingling in fingertips and toes. I have had muscle tension in upper back and shoulders, generalized irritability. It is affecting my sleep. I went to the emergency room today, and I have a doctor's appointment scheduled and neurology on Wednesday. ER gave me some fluids.
63 2021-03-02 anxiety Complained of dizziness after the shot. No lightheadedness or difficulty breathing. Patient stated t... Read more
Complained of dizziness after the shot. No lightheadedness or difficulty breathing. Patient stated that he was anxious before receiving shot. Hx of lightheadedness after flu shot. VSS. Patient remained seated x 30 minutes. Offered water and patient drank. Started feeling better after sat down and drank. Dizziness resolved. Feeling better, observed steady gait when leaving.
63 2021-03-03 feeling abnormal About 24 hours later I felt weak and had a fever and had little shivers that went thru my joints to ... Read more
About 24 hours later I felt weak and had a fever and had little shivers that went thru my joints to the top of my head. It almost like little shocks going thru my body. I had a video appointment with my Dr. and he prescribes doxycycline and prednisone. The next day the fever went away and started to feel better (48 hours later). I also tested positive for Covid on 12/24/20, I didn't wait 90 days before I got my vaccine. I felt awful with the second dose, almost worse than being in the midst of Covid. I'm currently on Workman's Comp. I'm constantly out of breathe and have no energy, I use to have tons of energy. From my atoms apple to my sternum I have tons of pain. My lungs feel like I'm smoking and have tons of pressure. My Dr. ran test because I have the worst head aches. I'm like slow motion.
63 2021-03-09 impaired work ability Maderna COVID-19 Vaccine EUA Got injection at 10:49 am Tuesday 3/9/21. At approximately 9:30 pm same... Read more
Maderna COVID-19 Vaccine EUA Got injection at 10:49 am Tuesday 3/9/21. At approximately 9:30 pm same day, started having chills and low grade fever of 99.3. Woke up around midnight with chills and body aches. Woke up at 5 am and was extremely fatigued. But fever was gone. Could barely get out of bed. Also had a headache. Able to go to work but left after being there for 45 minutes due to being dizzy, really fatigued, bad headache, and just sore all over. Got home and basically went to bed.
63 2021-03-18 feeling abnormal Fever, no energy,. Overall felt bad
63 2021-03-20 feeling abnormal some pain at the injection site tiredness headache body aches joint aches I felt bad for around 18 t... Read more
some pain at the injection site tiredness headache body aches joint aches I felt bad for around 18 to 24 hours the folling day i didn't feel great, but not bad either
63 2021-03-22 impaired work ability In November of 2020 I was diagnosed with COVID 19 and subsequently recovered. This was my first Mod... Read more
In November of 2020 I was diagnosed with COVID 19 and subsequently recovered. This was my first Moderna shot. I took the shot in the right arm and completed my work day with no side effects. I went to the gym that night - as usual - and wanted to "work that arm" a little. I had a good workout, no issues. Went home, ate and went to bed. About 1 or 2 am I woke up with the hottest raging inferno flu-like fever I can recall having as an adult. I did not want to alert my wife, so I simply stayed in bed and did not measure my fever level. My guess is it was >102. Fever continued until a.m. and deep body pain hit me. At dawn my fever measured 101. I took acetaminophen and took a cold shower. Fever subsided for a short while. Then it came back. I felt weak and flu-pain so I stayed home from work and simply slept it off. Symptoms slowly subsided by 7pm day 2. Day 3 I was not 100% but I went to work and was fine. No other symptoms since.
63 2021-03-24 impaired work ability Tinnitus,, no benefits of home remedies, had to go on work leave.
63 2021-03-25 restlessness, sleep disorder On 2-24-21 I received my first dose lot #030M20A and had flu like illness the following day that las... Read more
On 2-24-21 I received my first dose lot #030M20A and had flu like illness the following day that lasted all day. The 2nd dose I started to feel bad that afternoon , I didn't sleep at all that night running a fever, cold chills, my body was sore and ached,restless, headache , and very weak. If I knew this is how I would had felt I would have never got the shot! And I will never again it was that bad.
63 2021-03-27 poor quality sleep No immediate reaction. Five hours after injection upset stomach followed by light headedness, and fa... Read more
No immediate reaction. Five hours after injection upset stomach followed by light headedness, and fatigue. No fever. Loss of appetite. Soreness at injection site which spread from shoulder to elbow of left arm. Chills. Poor night's sleep with most symptoms continuing in morning.
63 2021-03-29 feeling abnormal Patient reported pain in center of black and vision blurry approximately 10 -15 min. Patient with po... Read more
Patient reported pain in center of black and vision blurry approximately 10 -15 min. Patient with poor color and sweaty. Patient Pulse OX 77% , HR 50. 1555 - Epinephrine 0.3mg administered IM left thigh. Oxygen (full face mask) applied at 15L. Patient pulse ox 98%. Patient report still feeling poorly. 1402 - Benadryl 100 mg IM Right Deltoid administered. 1406 - B/P - 125/82 Pulse Ox 98% HR - 56 Oxygen slowly decreased to 5 L. EMS transported to ER
63 2021-03-31 insomnia Aches, pains, chills, modest temperature, significant headaches, joint pain, insomnia, exhaustion
63 2021-04-01 insomnia Received the Moderna COVID-19 vaccine. Ten days after vaccination constant ringing in the ears pri... Read more
Received the Moderna COVID-19 vaccine. Ten days after vaccination constant ringing in the ears primarily on right side. Experienced low level tinnitus in the past which was tolerable. The ringing in the years is significant after the vaccine. It is now at a moderate level. Sleeping is difficult without using ambien. The ringing is constant through the day.
63 2021-04-05 nervousness Shortly after the patient got his immunization, he felt nausea and like he was going to throw up and... Read more
Shortly after the patient got his immunization, he felt nausea and like he was going to throw up and was sweaty. He was nervous and had thrown up before coming to the immunization appointment. He stated it is normal for him. He had to lay down and felt better after a couple minutes.
63 2021-04-05 sleep disorder I have a psoriasis rash, and maybe another rash mixed in. My joints have been sore. I can't sleep be... Read more
I have a psoriasis rash, and maybe another rash mixed in. My joints have been sore. I can't sleep because of the itching. I'm taking Orencia and was taking that at the time of the outbreak (I forgot to put that in the medicines that I take) that's given to me by my rheumatologist. He also prescribed lorazepam to deal with the excessive itching. Then I saw a dermatologist he gave me some shots in my skin, but there was so many of them it couldn't continue I would be a pin cushion. He also gave me some cream that really isn't working. Seems like it's getting worse instead of better.
63 2021-04-06 sleep disorder Fever, dizziness, vomiting, stomach aches, fainting, all body aches., fast heart beats, injection lo... Read more
Fever, dizziness, vomiting, stomach aches, fainting, all body aches., fast heart beats, injection location soreness and pain. Cannot sleep at night. I thought to call 911.
63 2021-04-07 loss of personal independence in daily activities Patient stated he experienced bilateral involuntary hand movement, bilateral hand weakness, bilatera... Read more
Patient stated he experienced bilateral involuntary hand movement, bilateral hand weakness, bilateral leg weakness "shaking" that started around 9 pm, and lasted until mid morning of 3/6/2021. Patient states, " I was unable to get out of bed for almost 2 days, due to shaking/muscle weakness." Patient states he experienced a fever at the same time. Patient called the nurse number to report a reaction/ seek care, but the patient states. "The person said there was nothing they could do to help him." Patient had person stay with him to assist him with daily cares.
63 2021-04-08 anxiety Patient came the the pharmacy for the Covid vaccination (Moderna). After Intra-muscular injection, P... Read more
Patient came the the pharmacy for the Covid vaccination (Moderna). After Intra-muscular injection, Patient was asked to stay for 15 minutes in order to observe the side effects/Allergic reactions if any. After 5 minutes-Patient reported that he is feeling anxiety or numbness on his left hand and arm. Patient states his left hand grip was not as strong as before.-We checked blood pressure, Blood pressure came out to be 212/116. We called the management Pharmacy protocol-Code White- for injury), Management asked the patient if we need to 911?. He said yes and we called 911. Paramedics took him to the hospital.
63 2021-04-08 sleep disorder Severe achiness, painful sleep.
63 2021-04-12 loss of personal independence in daily activities The patient came in this evening and wanted to report his adverse reaction to me. He stated that th... Read more
The patient came in this evening and wanted to report his adverse reaction to me. He stated that the day after he received his second dose of the Moderna COVID-19 vaccine on 3/26/21 he had several severe side effects start that are ongoing. He had a large red lump appear on his arm that was swollen, sore, and red. His arm is still sore. He also began to have severe body aches and weakness. He stated that the weakness has not gone away and he is still having difficulty performing daily tasks. He stated that he reported the reaction to his physician.
63 2021-04-12 sleep disorder Between 36 and 40 hours after shot (early Saturday AM), my RIGHT arm began to itch in the unhairy ar... Read more
Between 36 and 40 hours after shot (early Saturday AM), my RIGHT arm began to itch in the unhairy area to a degree that disturbed my sleep. I applied cortisone cream. About two hours later, BOTH arms were itching in the hairy areas. I applied cortisone cream to affected areas. A seeping sore eventually developed on each arm, and I started applying Clobestasol Propionate (leftover from prior eczema treatment) to those spots twice daily in addition to cortisone on other arm areas. After contacting my doctor's office via email, I was advised to continue with my self-administered treatments (but not use Clobestasol for more than two weeks and schedule doctor visit if rash/sores do not subside), and suggested I take antihistamine such as Zyrtec shortly after second vaccine shot to possibly prevent recurrence of reaction. Not yet recovered from rashes/sores, but treatments greatly alleviate symptoms.
63 2021-04-13 insomnia Patient's wife called PCP's office to report possible vaccine reaction. Approximately 4 days after ... Read more
Patient's wife called PCP's office to report possible vaccine reaction. Approximately 4 days after vaccine, patient had significantly worse neuropathy in bilateral extremities as well as sleeplessness. These are chronic conditions for the patient but per wife they were notably worse following vaccination.
63 2021-04-13 loss of personal independence in daily activities My left hand was in severe pain for maybe two hours. I took three Aleve to try and stop the pain. I ... Read more
My left hand was in severe pain for maybe two hours. I took three Aleve to try and stop the pain. I could not close my hand into a fist, nor could I hold anything in my hand. No grip at all. My hand remained like this for most of her night. Today it is a little better, I can close my hand and make a fist, but I am unable to close tightly and grip anything. I feel as though the strength in my left hand is gone for now. No pain today but the muscles in my wrist and in my left hand are still somewhat tight and present what feels like muscle tightness parallel to a pulling of the muscle. I rode my motorcycle to work yesterday, the morning ride was good, on the way home, my hand started with the pain thing. It was severe enough to prevent me from using the clutch lever properly. Presenting a lot of pain squeezing the lever to engage the clutch.
63 2021-04-13 mental status changes Patient had the COVID vaccine 5 days prior to admission, this was followed by diarrhea, body aches, ... Read more
Patient had the COVID vaccine 5 days prior to admission, this was followed by diarrhea, body aches, intermittent shortness of breath and general feeling unwell. Most resolved but the diarrhea and intermittent respiratory distress, this worsened on day of admission (4/11/21) with decline in mental status. Nausea with no vomiting, no fever, no cough. Patient was admitted to the ICU with acute respiratory failure with hypoxia and pneumonia. Placed on BiPAP, IV fluids. Patient is currently in the ICU with diagnosis encephalopathy, bilateral aspiration pneumonia, right pleural effusion and UTI. Discussed patient with Health Department who requested patient be reported to VEARS for review.
63 2021-04-14 sleep disorder sore arm at injection point, fever, muscle aches, chills, sweats, tiredness, trouble sleeping
63 2021-04-17 feeling abnormal Unusual (reason for submission): Blood 02 dropped to 94-96 the day after 2nd COVID vaccination. I ... Read more
Unusual (reason for submission): Blood 02 dropped to 94-96 the day after 2nd COVID vaccination. I take O2 reading daily (generally). Always been rock solid at 98 with maybe a 97 every two months. This is really an outlier event. Reading taken on six different fingers with one monitor reset. Returned to 98 following day. Other expected symptoms: Temp 99.8 (generally 97.6 - 98.0). Injection shoulder sore, felt puffy (but no visual difference). Medium "Brain Fog" (senses seemed disconnected, lack of concentration). Lethargic legs (not sore or weak, just slow to respond). Left neck and ear aches. Slept about 14 hours day after shot. No symptoms other than sore arm the day of shot. BP and blood sugars up, but at higher end of my normal ranges. BP 175/93 (16th). (at 149/93 on 17th). Blood stick reading 198 (16th). (at 158 on 17th)
63 2021-04-18 feeling abnormal Next day (Friday) Very sore arm at injections site, body aches, muscle aches, join ache, temperature... Read more
Next day (Friday) Very sore arm at injections site, body aches, muscle aches, join ache, temperature 100.5 day after. Felt like I got hit by a bus. Better on Saturday
63 2021-04-18 loss of personal independence in daily activities later that night patient began to have extreme back pain, legs hurt even to touch (lasted for days),... Read more
later that night patient began to have extreme back pain, legs hurt even to touch (lasted for days), knees rubbery ...patient had pain for 11 days...patient had dizziness and his balance was off...patient had difficulty breathing ...patient stayed in the er all day underwent a battery of tests "all day" ...in the end didnt have answers ....still having problems breathing and coughing ...patient was zapped of all energy and had difficulty even dressing self
63 2021-04-21 feeling abnormal, disturbance in attention very sore arm, nausea, headaches, high temperature (99.4), felt like a zombie, felt sick, stayed in ... Read more
very sore arm, nausea, headaches, high temperature (99.4), felt like a zombie, felt sick, stayed in bed, unable to concentrate
63 2021-04-22 confusional state Patient received first dose of Moderna COVID-19 vaccine on 3/31/2021. Vaccine given at 0857. Patient... Read more
Patient received first dose of Moderna COVID-19 vaccine on 3/31/2021. Vaccine given at 0857. Patient complained of dizziness, confusion, fatigue, and mild SOB. He was evaluated by PCP and PA-C. BP 150/100 and glucose 156. EMS evaluated the patient and did not send to ED. Patient was observed for 30 min.
63 2021-04-22 sleep disorder I received my second dose of Modena vaccine last Thursday (4/15) morning at 9am. No initial reactio... Read more
I received my second dose of Modena vaccine last Thursday (4/15) morning at 9am. No initial reaction occurred. Later that Thursday my arm got the expected tenderness, muscle ache. Towards evening, I got pretty tired and was starting to get some body aches, took 2 tylenol and went to bed at 9pm. Slept in late and was tired. Started to feel like mild flu which is what I expected. Friday took some naps and continued mild flu symptoms. Went to bed about 8pm and got up at 5:00, feeling a bit better. Saturday I continued to improve, arm was much better, less flu symptoms, didn't need tylenol, had turned the corner. Cont'd... Saturday evening was going to go to bed at 10pm and noticed my left cheek was kind of pressing against my gums - it was swollen. It continued to swell some but was not hindering my throat or breathing. I decided to stay awake, keep an eye on it and if necessary would go to an emergency room. The swelling increased only slightly more over the next couple of hours to the size of maybe a golf ball (a bit less) on the left side and a much smaller amount on the right side. No airway effects. I did apply some ice but not sure if that had an effect. I slept for a few hours. Sunday morning I did not take my medications as a precaution. Sunday the swelling was slightly less and seemed to be going down a bit. I took 2 Benedryl at 11:00 am which really knocked me out, slept. Sunday evening the swelling was noticeably improved but not gone. Took 1 Benedryl at 10:00pm bedtime. Monday still had a bit of swelling on left and right swelling is nearly gone. No other symptoms.
63 2021-04-23 poor quality sleep Today is day 10 since vaccination. Past 2 days unusual post nasal drip and restless sleep. This mor... Read more
Today is day 10 since vaccination. Past 2 days unusual post nasal drip and restless sleep. This morning red rash appeared at injection site on right arm, and right are is getting sore at injection site.
63 2021-04-24 insomnia Began feeling warm within a few hours after vaccine. Was clammy at first, with slightly elevated te... Read more
Began feeling warm within a few hours after vaccine. Was clammy at first, with slightly elevated temperature. By nighttime, had severe shaking, chills, profuse sweating & unable to sleep. We didn?t take temperature, but he finally stopped shaking mid-morning the following day. Was weak and very fatigued two full days. It was like an instant flu, but it was only the first jab and most reports of reaction seem to follow the 2nd. Think it may be due to presence of antibodies post-COVID.
63 2021-05-01 depression, suicidal thoughts Patient experienced fatigue, extreme body aches, fever and very extreme depression and thoughts of s... Read more
Patient experienced fatigue, extreme body aches, fever and very extreme depression and thoughts of suicide. Refused treatment. Symptom of fever (101.2) passed within 12 hours. Symptoms of severe body aches lasted 48 hours. Symptoms of extreme depression and suicidal thoughts lasted 24 hours.
63 2021-05-02 loss of personal independence in daily activities 4 days later (5/1/2021) anaphylactic shock after a bee sting. No allergy to bee stings before. Whole... Read more
4 days later (5/1/2021) anaphylactic shock after a bee sting. No allergy to bee stings before. Whole body rash with severe itching, swelling in mouth and throat, extreme weakness, close to fainting within minutes. Emergency room visit, EPI pen injection, steroid injection, EKG, chest x-ray, blood work. 4 hours of observation in hospital. Still weak today, voice weak, and can't seem to take in enough oxygen to go on a walk or do simple yoga stretches.
63 2021-05-02 sleep disorder A Week after my first dose ~ I had a rash all over my body 14 hours after my second dose. I awoke t... Read more
A Week after my first dose ~ I had a rash all over my body 14 hours after my second dose. I awoke to a very painful cramp about an inch below my left rib on my left side that lasted for almost 2 hours. The more I moved, the worse it became. I could not go to the bath room and when I drank water, the cramp intensified. Worse pain that I had ever experienced. I sweated profusely. Felt like I got kicked in the side. I was not nauseous, a little dizzy for a moment. My mouth was dry only because of my heavy breathing. My second episode happened the following Saturday morning, I don't think that it was as intense, but it felt like it was only because my left side was sour from Friday mornings episode. My third and final episode happened again early Sunday morning. This one was not as intense, but still woke me up and made me struggle. I did not experience another episode on the 4 the night from my second dose. At this time, my left side feels bruised internally and I have to change the speed of my walk. It hurts to walk fast
63 2021-05-07 sleep disorder Hello, Had the 2nd Moderna COVID-19 vaccine at the pharmacy on April 2nd at 6:45 PM. The nurse ask... Read more
Hello, Had the 2nd Moderna COVID-19 vaccine at the pharmacy on April 2nd at 6:45 PM. The nurse asked me to stay around the store for 15 minutes for any immediate side effects, and to drink plenty of water when I got home. Did some shopping, and probably left about 30-45 minutes after the shot with no side-effects, and when I arrived home about another 45 minutes later still had no side effects. Upon waking the next morning my right arm where I received the shot was extremely painful, and I could not raise any higher than parallel to the floor without extreme pain for 2-3 days. Then I also started with a slight fever, which of the times checked, reached about 101. Also was getting muscle and joint soreness, and later that started getting extreme cramping in my leg calf muscles while sitting on the couch. I then had to stand up for 5-10 minutes, or walk around a little and then after sitting the extreme cramping would begin again so I would have to stand up again. That went on all day. When laying down that night the cramping would subside enough to sleep a little on and off during the night. The calf muscle cramping started to gradually subside, but took about 17 days to go completely away. The day after the vaccine when my legs were cramping I was extremely worried about possible leg clots since I had never had extreme leg cramping like that my entire life, and I was drinking plenty of water like the nurse recommended. Best regards,
63 2021-05-09 insomnia Ringing Ears all day long (Tinnitus?) Occurred after 3 days to a week. Affecting quality of sleep. ... Read more
Ringing Ears all day long (Tinnitus?) Occurred after 3 days to a week. Affecting quality of sleep. Worse at around Bed time. Also noticeable fatigue. Running at about 80-90% of my previous normal.
63 2021-05-19 feeling abnormal 5-19-21 Patient self-reported to that 8 days after receiving his first dose of Moderna (3/18/21), h... Read more
5-19-21 Patient self-reported to that 8 days after receiving his first dose of Moderna (3/18/21), he began coughing up blood, was taken to the hospital, transferred to the ICU with thrombosis. He states he was in the ICU for 6 days. He then received second dose on 04/09/21 and was ill for 5 days again. States he currently remains fatigued, short of breath and "just not himself." Patient is concerned that the blood clots were related to his COVID Vaccines.
63 2021-05-21 excessive sleepiness, hallucination, fear, confusional state feel weak; this one really scared me; bone pain; Dizzy; arm is still painful; I do not know what hap... Read more
feel weak; this one really scared me; bone pain; Dizzy; arm is still painful; I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened; Joint pain; Achy, body pain; worst experience, I was in coma for 2 days; hallucinated; was sweating all over; Did not eat in two days; not woke up, just sleep; This spontaneous case was reported by a consumer and describes the occurrence of COMA (worst experience, I was in coma for 2 days) and HALLUCINATION (hallucinated) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE and Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine and PNEUMOCOCCAL VACCINE. On 05-May-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced COMA (worst experience, I was in coma for 2 days) (seriousness criterion medically significant), HALLUCINATION (hallucinated) (seriousness criterion medically significant), HYPERHIDROSIS (was sweating all over), FEEDING DISORDER (Did not eat in two days), HYPERSOMNIA (not woke up, just sleep), BONE PAIN (bone pain), DIZZINESS (Dizzy), PAIN IN EXTREMITY (arm is still painful), CONFUSIONAL STATE (I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened), ARTHRALGIA (Joint pain) and MYALGIA (Achy, body pain). On 07-May-2021, the patient experienced FEAR (this one really scared me) and ASTHENIA (feel weak). On 07-May-2021, COMA (worst experience, I was in coma for 2 days), FEEDING DISORDER (Did not eat in two days), HYPERSOMNIA (not woke up, just sleep) and CONFUSIONAL STATE (I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened) had resolved. At the time of the report, HALLUCINATION (hallucinated), HYPERHIDROSIS (was sweating all over), FEAR (this one really scared me), DIZZINESS (Dizzy) and MYALGIA (Achy, body pain) outcome was unknown and BONE PAIN (bone pain), ASTHENIA (feel weak), PAIN IN EXTREMITY (arm is still painful) and ARTHRALGIA (Joint pain) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. The patient did not receive any treatment medication. No concomitant medication was reported. The patient spoke to his doctor about not getting the 2nd shot. Based on the current 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 2021-05-23 insomnia SEVERE ARM PAIN IN RIGHT ARM IMMIETELY AFTER RECEIVING VACCICE, NOW GETTING WORSE, WEAKNESS, LOSS OF... Read more
SEVERE ARM PAIN IN RIGHT ARM IMMIETELY AFTER RECEIVING VACCICE, NOW GETTING WORSE, WEAKNESS, LOSS OF FEELING, SHOULDER PAIN, ELBOW PAIN HAND PAIN-CANNOT MOVE ALL MY FINGERS, SORENESS, SLEEPLESSNES DUE TO PAIN ,NUMNESS, CANNOT LIFT,CANNOT SWIM , CANNOT USE THAT ARM AT ALL
63 2021-05-24 sleep disorder He got his vaccine, he had no reactions. The next morning he woke up his arm was sore, and it was t... Read more
He got his vaccine, he had no reactions. The next morning he woke up his arm was sore, and it was that was for 2 days. Then his breathing starting getting worse. He started coughing, couldn't lay down, could not sleep due to that. He went to the ER and they told him that there was nothing wrong and that it was just allergies. They told him to go home and take some OTC cold medicine and that everything would be okay. A week later he went to another ER for the same thing as he continued not to be able to breath, they did a bunch of tests and said that nothing was wrong and that it was just a call. He then went to Hospital ER and they released him stating it had just a cold. He then called his cardiologist and they told him to go back to Hospital, was admitted on 5/11/21 and they did more tests and said that he had a blood clot in his left lung and said that it had nothing to do with the vaccine. He was discharged on 5/13/21. They put him on Heparin while in the hospital and sent him home as a disgruntled patient. They also told him that he had fluid around his heart and gave him medicine to get that taken away. They sent him home on Lasix and Eliquis. He then went to another hospital on Friday 5/14/21 as he was going crazy about the blood clot and went there and was kept there for 3 days and discharged on 5/16/21 with the same medications, Lasix and Eliquis. He was also told that he had fluid around his heart again. Before the vaccine he was very healthy, and was able to jog around his neighborhood and now he's not able to do so, and they told him that he was now having heart failure and is having trouble breathing because his heart is swelling up. He went to see his cardiologist last Friday and that's when she told him about his heart failure. ADMISSIONS: ADMITTED 5/11/21 TO 5/13/21; 5/14/21 to 5/16/21.
63 2021-05-26 feeling abnormal Fever went up to 37 degrees celsius at 10.30 am, about 18 hours after vaccination. Shortly after a s... Read more
Fever went up to 37 degrees celsius at 10.30 am, about 18 hours after vaccination. Shortly after a strong headache arose. I became very weak and felt bad for the whole day 27th may. I woke up this morning with all the above symptoms disappeared.
63 2021-05-29 confusional state Patient lost consciousness and was in and out for roughly 5 minutes. Clammy, sweaty, confused. EMS w... Read more
Patient lost consciousness and was in and out for roughly 5 minutes. Clammy, sweaty, confused. EMS was called. vitals checked. patient cleared. pt went home from pharmacy with wife.
63 2021-06-01 loss of personal independence in daily activities After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't kno... Read more
After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet; sweating; started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013; started walking slow; sleeping a lot; they were leaking out; got real sick; could not drive; what used to be daily life ended; arm hurting; my husband died in the hospita at 4:30 AM"; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (my husband died in the hospita at 4:30 AM") in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart failure since 2013. 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 an unknown date, the patient experienced HAEMORRHAGE (After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet), HYPERHIDROSIS (sweating), ASTHENIA (started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013), GAIT DISTURBANCE (started walking slow), SOMNOLENCE (sleeping a lot), URINARY INCONTINENCE (they were leaking out), VACCINATION COMPLICATION (got real sick), IMPAIRED DRIVING ABILITY (could not drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (what used to be daily life ended) and VACCINATION SITE PAIN (arm hurting). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet), HYPERHIDROSIS (sweating), ASTHENIA (started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013), GAIT DISTURBANCE (started walking slow), SOMNOLENCE (sleeping a lot), URINARY INCONTINENCE (they were leaking out), VACCINATION COMPLICATION (got real sick), IMPAIRED DRIVING ABILITY (could not drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (what used to be daily life ended) and VACCINATION SITE PAIN (arm hurting) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: normal (normal) Normal. In 2021, Endoscopy: normal (normal) Normal. Reporter could not provide the list of concomitant medications or hospital details. 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. Regarding the event death, very limited information has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Regarding the event death, very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
63 2021-06-03 feeling abnormal ABOUT 4 HOURS AFTER 2ND DOSE PATIEN STATES TINNITIS ABOVE/TOP OF HEAD AND BRAIN FOG.
63 2021-06-07 disorientation Incontinent of stool, disorientation, low O2 sats
63 2021-06-10 loss of personal independence in daily activities Serious lower left back which I believe was my left kidney. The serious pain problems started the da... Read more
Serious lower left back which I believe was my left kidney. The serious pain problems started the day after receiving the shot and lasted for at least two weeks. As the kidney pain started, my fingers started to feel numb and they have felt numb ever since. Left hand is a little worse then my right hand. Want to get second shot but?? I have walking pneumonia since 1973, since I was 15 years old, and will die if I get Covid 19. I need help to know what happened to me, and maybe monitor me during second shot. I am open research person. I am a 64 year old man that has had walking pneumonia since I was 15 years old in 1973. I know that if I do get Covid-19 I will quickly die. I need vaccination from Covid-19. I received my first Moderna Covid 19 vaccine on Thursday March 18th, 2021 after 3 PM and immediately had problems. I had problems in my left lower back which I believe was my left kidney. The serious pain problems started the day after receiving my first Covid 19 Moderna shot and the pain lasted for at least two weeks. Immediately as the kidney pain started, my fingers started to feel numb and they have felt this way ever since. This lead me to the situation of "I am damned if I do and damned if I do not". I want to get the second Covid-19 vaccine shot because I am truly scared to die if I do get Covid 19. But if I do get the second shot, what will happen to me? I am scared that it may have the kidney pain again, may worsen my numb fingers problem, and/or do other damage to my body. It may already have caused other problems? In summation, whether I get the second Covid-19 vaccination shot or not: Get the second shot: 1. Everything could be OK? 2. I could have Kidney pain again, possibly doing damage or more damage to my body, even my numb fingers could get worse! Not get the second shot: 1. Be lucky and not get Covid-19. 2. Get Covid-19 and die. I want very much to get the second Covid-19 shot, but I am scared and I find nobody cares about what had and has happened to me regarding my kidney pain and my fingers becoming numb, and any future consequences to me if I get the second shot. I do not know what to do. My current and main concern to me, for now, that if I do get the second Covid-19 shot I will get that kidney pain and may do worse damage to my fingers feeling numb or possibly other damage to my body. I am not sure what happened, as a non medical person I can only guess things like maybe I have blood clots that reduce the circulation in my hands. I just recently got on government assistance only because of this Covid-19 problem and I had a very hard time trying to find a job, I had no choice. I have not been on government assistance long enough to get financially stable to afford medical insurance, but I plan to do so as soon as I can. I tried to tell my doctor, but she kept telling me to go to the emergency room. So, I finally went to the Hospital on Friday April 16th. They checked my bloodwork and told me I was OK and OK to get the second shot, but I had really no explanation as to what had happened to me, my kidney, or my still numb fingers, or most of all, what might happen if I get my second shot. I am hoping to get help, for someone to care about me, my health, and my future health. The numbness in my left hand has been a little stronger than my right hand. I had the shot in the left arm and my left kidney had the pain, if any of these matter. The left kidney problem was very painful within 2 days. I could not do anything due to the pain. I could forget about dealing with my feet in any way, such as to tie or untie shoes, put on or remove socks, getting out of bed, and just about anything I did, any movement at all was very painful. What has me very worried is the continuous numbness of my fingers. I want to get back to work and my profession involves computers and keyboards, and my numbness in my fingers bothers me, even having problem feeling the raised bump on the ‘f' and ‘j' keys. The most immediate problem is trying to untie shoestrings, which I cannot feel to do due to my fingers feeling numb. This problem with my fingers affect my life in many ways continuously everyday. I cannot feel zip lock bag openings. I have had a left kidney problem once before over 2 years ago, which I believe was a result of doing Benicar for my blood pressure. I have only had that problem that once and I got off Benicar and have never had the problem since, not until a day after I had my first Moderna Covid 19 vaccine shot March 18th. For both of these times, the left kidney pain I immediately stopped all of my medicines and after a few weeks the pain went away. This time was muc worse than the first time. I have high blood pressure, diabetes, and high cholesterol and take medicines for these. I resumed these medicines after the pains went away. As to the fingers feeling numb, I have never had this problem in my life. My left hand fingers are a little worse than my right hand fingers. They feel as if they are very cold for frozen, or I have burnt my fingers. I have never felt this feeling ever in my life. At the beginning of, January 1st to be exact, when I was 15 years old and in the 10th grade, I came down with pneumonia and was very sick. It was not until the middle of March when my mother took me to the emergency late at night when she got a doctor to see me on the side. The doctor gave me prescriptions of antibiotics, cough syrup, and Guaifenesin (which was a prescription in 1973 and is the main ingredient in Mucinex). For the next 2 weeks I came home from school and laid down on the sofa and filled up about a third to a quarter of a medium size mixing bowl with phlegm from my lungs. After that doctors have told me I ruined my lungs and I will have walking pneumonia for the rest of my life. I have lived with this problem and have had to pay special attention to my lungs my whole life. When I saw on TV a report on the second e-cigarette and what if did to the lungs, I said that looks like what happened to my lungs when I was 15 years old. I recently saw news that someone had a similar problem. However, because of my walking pneumonia I need to get the second shot or vaccinated in whatever way, I want to live. Please help!
63 2021-06-14 confusional state, mental impairment, impaired work ability THE Night of the injection a fever developed. Severe fatugue and feeling sick. After two days this ... Read more
THE Night of the injection a fever developed. Severe fatugue and feeling sick. After two days this subsided but had impacted my immue system enough to cause a relapse of Babesia to the point where I had encephalitis. The encephalitis caused confusion and reduced mental ablity to the point where I had to leave work and go on short term disablity which am on still. The people administering the vacine asked me if I was immune compromized and I told them YES. They asked why and I told them Lyme Disease. They administered the Vaccine any way.
63 2021-06-17 feeling abnormal The evening of his second shot, he collapsed. He said he became light headed, but I believe he may ... Read more
The evening of his second shot, he collapsed. He said he became light headed, but I believe he may have lost consciousness briefly. He rand a low fever for 12 hours. Afterwards, he complained that he had "not felt right" since the second shot. He died of a heart attack on May 27, roughly one month after his second shot.
63 2021-06-18 sleep disorder Hives/rash first appeared near injection sight on 6/1/2021, becoming more severe through 6/9/2021. M... Read more
Hives/rash first appeared near injection sight on 6/1/2021, becoming more severe through 6/9/2021. Medical intervention was sought from primary healthcare provider on 6/9/2021, whereas the hives became severe and facial swelling on the right side of the face appeared and lasted from 6/10/2021 through 6/14/2021. It was during this time that eye irritation appeared. As of this reporting the hives are still persisting, coming in 'waves' of almost unbearable itchiness, varying between a few minutes to 3 hours, with the duration varying between a few minutes to 3 hours as well. Disrupted sleep cycles have been a peripheral side affect, caused by the hives
63 2021-06-19 feeling abnormal, disturbance in attention Dizzynies, loss of balance, loss of apitite, chils, redness, swelling, mild fever, altered sense of ... Read more
Dizzynies, loss of balance, loss of apitite, chils, redness, swelling, mild fever, altered sense of smell and taste, headache, joint pain, muscle aches and pain, cough, "brain fog", extreem fatigue, body aches, shortness of breath, difficulty concentrating, loss of taste or smell.
63 2021-06-19 impaired work ability Fine until about 4 a.m. on the 20th, day after vaccine. Woke up with uncontrollable shaking, nausea ... Read more
Fine until about 4 a.m. on the 20th, day after vaccine. Woke up with uncontrollable shaking, nausea and teeth chattering, cold and could not move my left arm . Same arm as shot. I had a temperature of 101.2 Took tylenol, still sore and chills. Had to call in to work to say I was sick. Took naps mostly throughout the day, fever still persisting around 101. Took Tylenol, 2 hours later fever down to 99.1. Could not stay awake for long. Slept most of the day.
63 2021-06-22 mental status changes The patient began having body pain, diaphoresis, dyspnea, abdominal pain, and fatigue approx 14d pos... Read more
The patient began having body pain, diaphoresis, dyspnea, abdominal pain, and fatigue approx 14d post-COVID vaccine (2nd dose, Pfizer). He presented to our hospital on 6/18 with these complaints and was found to have significantly altered mentation, acute kidney injury, and profound thrombocytopenia. Workup was positive for TTP and he was started on PLEX therapy x 5d. Hematologic parameters, renal function, and mentation have improved with PLEX therapy. ADAMTS-13 activity <5% c/w acquired TTP.
63 2021-06-24 sleep disorder, loss of personal independence in daily activities I started feeling cold and shaking and very bad headache and discomfort all over. I was bedridden fo... Read more
I started feeling cold and shaking and very bad headache and discomfort all over. I was bedridden for a couple of days, then it got a little bit better and then it got worse again. Then it got hard to breath. So I lost over 30 pounds in the matter of a month and that is unlike me, I have always been overweight and a food addict and so I called the DR and they told me to get a covid test because the symptoms were similar. I got the test and it was negative. I went to the ER and they said I got pneumonia, which I do not know is related or not but it did happen after the shot and seemed pretty odd. I tend to be the person to just tough things out. At the ER they told me pneumonia in my right light and gave me antibiotics. I called my pulmonologist when home because it was getting worse and he prescribed more antibiotics. I went to see him and he took another x-ray of my lungs. I still had stuff in my lungs so he gave even more antibiotics. He took another x-ray and CT scan recently that I do not have the results of yet. I have vertigo which just started about two weeks ago as well, I read about exercises to do for that and it helped a bit but it came back and now cannot get rid of it. It still is kind of hard to breath as well. I have no appetite which is weird for me and I am cold which is also very strange. I usually could go in a cold place of like 35 degrees and be fine and now I am just always cold. Even when I know I'm hot and know it's hot, I am cold and using a blanket. I shiver and shake so much from being so cold but my bed is soaking wet from sweating, it just doesn't make sense. I have a hard time going to sleep because I am cold and uncomfortable. Even today I am still very tired and now with the vertigo it is hard to do anything today, just talking a lot like right now I am out of breath.
63 2021-07-05 memory impairment Migraine headache hit and was excruciating pain that wasn't lessened by any over-the-counter pain re... Read more
Migraine headache hit and was excruciating pain that wasn't lessened by any over-the-counter pain reliever. The migraine continued on a constant basis that had my husband in bed in the dark for 8 days straight. I contacted his Physician numerous times and also the Nurses line. After numerous contacts he was finally prescribed Imitrex pills. He took 2 separate doses that finally had the migraine lift in intensity. His Physician was reluctant to prescribe a second prescription to have on hand if this reoccurred. The migraine headaches have continued. My husband saw his Physician June 28th but we haven't received it. In addition to the migraine his ulcer flared up due to the over-the-counter medication. Another development in my husband is his cognitive decline and his short-term memory is really bad. My husband retired at age 62 years after running a bank with numerous staff for 43 years. There is no way that he could be running the bank if he was still working. I strongly believe that these health issues are because of the vaccine!
63 2021-07-11 feeling abnormal After 1st shot he was paralyzed from waist down; He felt like he lost a good chunk of his life, got ... Read more
After 1st shot he was paralyzed from waist down; He felt like he lost a good chunk of his life, got screwed; This spontaneous case was reported by a consumer and describes the occurrence of PARAPLEGIA (After 1st shot he was paralyzed from waist down) and FEELING ABNORMAL (He felt like he lost a good chunk of his life, got screwed) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 21-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 PARAPLEGIA (After 1st shot he was paralyzed from waist down) (seriousness criterion medically significant) and FEELING ABNORMAL (He felt like he lost a good chunk of his life, got screwed) (seriousness criterion medically significant). At the time of the report, PARAPLEGIA (After 1st shot he was paralyzed from waist down) and FEELING ABNORMAL (He felt like he lost a good chunk of his life, got screwed) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product was not provided by the reporter. It was noted that the patient lives in a assisted living facility. After the onset of events, the patient reported that he was put in a wheel chair but no longer needs the wheel chair. The patient was also advised by his doctor's not to receive the second shot. Further information regarding treatment was not reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
63 2021-07-13 loss of personal independence in daily activities Inflammatory arthritis, systemic. Stiffness, swelling, immobility, pain; persisting. Onset 24 hours ... Read more
Inflammatory arthritis, systemic. Stiffness, swelling, immobility, pain; persisting. Onset 24 hours after covid vaccination, unresolved. Unable to write, sit in boat, grip, disability of other ADLs. Treatment: marked improvement with prednisone, no improvement with 7.5mg methotrexate / week
64 2021-01-02 impaired work ability Pain at injection site; much less than flu shot. No treatment. Resolved by Jan 2. Brief bouts of diz... Read more
Pain at injection site; much less than flu shot. No treatment. Resolved by Jan 2. Brief bouts of dizziness and nausea; stayed home from work and rested. resolved by Jan 1. Seasonal allergy symptoms- runny nose, including bloody nose from left nostril. Resolved by Jan 2. Allergic reaction to a scented hand cream used by wife- burning eyes, nasopharyngeal tightness, nasal discharge. Wife since removed so I can't tell you brand. Occurred/Resolved Jan 1 when product was removed.
64 2021-01-06 impaired work ability Headache & Myalgia Narrative: myalgias, headache, stayed home from work for a day
64 2021-01-07 confusional state Roughly 24 hours after injection, I experienced confusion. I had an appointment with a client, I'm a... Read more
Roughly 24 hours after injection, I experienced confusion. I had an appointment with a client, I'm a Mental Health case manager. The appointment was at 4:00pm. I left at 3:45 to go pick her up. Around 4:30pm I knew that I was lost and had no idea where I was at. I finally came across a main highway that took me to my targeted location. I went into a store to ask the clerk directions. I've lived in town for over 46 years, yet I had no idea where I was at. Very scary.
64 2021-01-07 memory impairment Severe musculoskeletal pain, severe fatigue, poor memory, poor cognitive function, weight loss, loss... Read more
Severe musculoskeletal pain, severe fatigue, poor memory, poor cognitive function, weight loss, loss of appetite, injection site pain
64 2021-01-08 euphoric mood Myalgia Euphoria, heavy legs Narrative:
64 2021-01-11 confusional state On 12/31/2020, at approximately 00:15, pt developed a fever of 102.9 F and tachycardia with rate of ... Read more
On 12/31/2020, at approximately 00:15, pt developed a fever of 102.9 F and tachycardia with rate of 120. He was treated with acetaminophen. Later in the morning, he complained of nausea, generalized muscle aches, intermittent increase in confusion. At approximately 14:00, he had a fall out of bed and at that time noted to be short of breath, tachypneic. He was taken via ambulance to Emergency Department. From there he was transferred to Hospital for admission with acute respiratory distress, suspected sepsis with lactic acid 7.4 and Bilateral Pulmonary Emboli. He was started on heparin and broad spectrum antibiotics and transitioned to ELIQUIS on 1/3/2021. Infectious etiology of sepsis was unclear. He continued broad spectrum antibiotics with clinical improvement. Abdominal CT scan was obtained due to intermittent nausea, vomiting, abdominal pain, loose stools. His heart rhythm flipped to Atrial Fibrillation with RVR on 1/2 and his rate improved with titration of metoprolol. He was also treated with prednisone for suspected underlying undiagnosed COPD. It is noted in his hospital summary that PEs presumed provoked in the setting of his recent COVID 19 infection. He was discharged from the hospital on 1/8/2021 and readmitted to the Veterans Home. He has been stable.
64 2021-01-18 sleep disorder Muscle soreness in left arm for the first two days then marked fatigue on days 3-4, major urticaria ... Read more
Muscle soreness in left arm for the first two days then marked fatigue on days 3-4, major urticaria developed on day 8 after vaccination with large patches of red, raised, very itchy rash on both sides of the anterior abdomen, with smaller patches on both of the lower legs and some on the posterior upper arms. The itching made sleep very difficult for the next two nights. The itching was decreased somewhat by the use of 1% hydrocortisone cream and moreso by 10 mg of Loratidine. The severity of the urticaria has decreased somewhat over the last 3 days since onset but is definitely still present.
64 2021-01-19 impaired work ability patient states he felt fine the day he received the vaccine, but at 0500 on 1/15/2021 he was woken o... Read more
patient states he felt fine the day he received the vaccine, but at 0500 on 1/15/2021 he was woken out of his sleep having difficulty breathing. He estimates this episode lasted 30 seconds- 1 minute. he drank a sip of water thinking that would help. He then had a second more severe episode that lasted about 2 minutes. "I could not breathe, it felt like I was under water". H stated that after the episodes he felt jittery and very fatigued the rest of the day. He stated that the second episode was the worst he had ever had and thought he was going to pass out. He is a nonsmoker with NKDA. He does have asthma. He is on an inhaler and has a rescue inhaler. He stated that his last episode was 3-4 months ago, but these episodes were different. " It was a bigger fight to breathe". On 1/18/2021 at 2100 He had another episode that lasted 1-2 minutes. He used his inhaler, and improved. He was weak and dizzy after this episode and was unable to go to work.
64 2021-01-21 anxiety Patient had an argument about some issues, so he got excited while he was waiting for observation in... Read more
Patient had an argument about some issues, so he got excited while he was waiting for observation in the post vaccination area. He had a complaint of feeling of light headed and anxious . No SOB, no chest pain, no headache, no dizziness, no visual problems. Vital signs: BP-142/90 HR-84 O2 Sat-99% He had good color, good O2 saturation and was alert and active, Oriented X3 in NAD. I told him to relax ,take deep breaths and was watching him for almost 30 minutes after he reported feeling light headed. Lungs was CTA and heart rate was normal. H/O HTN. Informed patient to relax gave him post vaccination care instructions and told him to drink enough fluids and take Advil or Tylenol PRN for pain relief.
64 2021-01-24 mental impairment, feeling abnormal Foggy headed, lost train of thought, unable to form complete sentences
64 2021-01-26 impaired work ability headache, fatigue, aches (missed work)
64 2021-01-28 insomnia Complaint of headache upon waking next day after receiving vaccine. Heachache accompanied by loss of... Read more
Complaint of headache upon waking next day after receiving vaccine. Heachache accompanied by loss of appetite, chills, generalized discomfort, chest pain, difficulty breathing, and difficulty sleeping. All symptoms resolved with the exception of headache and difficulty sleeping until day 2 after receiving vaccination. Day 2 without symptoms
64 2021-02-03 feeling abnormal Resident had chest pains and rapid heart rate and felt like he was going to have a seizure. Laid bac... Read more
Resident had chest pains and rapid heart rate and felt like he was going to have a seizure. Laid back down for a few hours, then EMT called at 6:19 am and transported to hospital. Hospital update that he does have a fever and have him on IV fluids. Tests came back that his cumin levels were high. Patient is back home.
64 2021-02-03 thinking abnormal, sleep disorder, confusional state, abnormal dreams The next day in the evening I experienced fever of 102 and I had chills, achiness in my body. I cou... Read more
The next day in the evening I experienced fever of 102 and I had chills, achiness in my body. I couldn't sleep, my thinking patterns were little confused, I was confused. I was also having adverse dreams. By Monday the fever went down, and the body aches and tiredness went down some. On Monday I went and got a COVID test and got a positive. Up to time of vaccination I have tested negative. The place that gave me the COVID test said it could be a false positive due to recently being vaccinated. The person from the COVID test said it was safe to get the 2nd dose. I feel okay right now and I am out and about.
64 2021-02-04 loss of personal independence in daily activities 36 hours following the vaccine I was having a bad headache, moderate to severe pain at injection sit... Read more
36 hours following the vaccine I was having a bad headache, moderate to severe pain at injection site, and severe diarrhea. The diarrhea lasted about 12 hours. I also felt general discomfort over entire body as if I had flu. This discomfort lasted for approximately 2 to 3 days. I was unable to perform normal activities during this time.
64 2021-02-04 sleep disorder Took Tylenol after injection at approximately 9:30 AM on 26 January 2021; approximately 1:30 AM on 2... Read more
Took Tylenol after injection at approximately 9:30 AM on 26 January 2021; approximately 1:30 AM on 27 January 2021 was awakened by severe chills/tremors/ rigors (to the point it was difficult to hold a glass of water); took Tylenol and waited approximately 1.5 hours for chills and 100 deg. temp to subside. Took Advil at approximately 8:00 AM. Worked all day and at approximately 7:30 PM began having chills again and a fever of 101 deg. temp. Took Tylenol and temperature began lowering and I went to bed. Woke up again at approximately 1:30 AM 28 January 2021 with significant sweating. Took my temp and it was near normal. No further side effects/symptoms following this event.
64 2021-02-17 impaired work ability, insomnia The vaccine was given to me at seven o'clock on Friday night. I had a really bad time after that. I ... Read more
The vaccine was given to me at seven o'clock on Friday night. I had a really bad time after that. I had headache, pain, cold sweating, tired, very ill, the pain did not let me sleep, overheated, I had to rest for two days and I did not go to work until Tuesday.
64 2021-02-18 mental status changes altered mental status, pt was observed x 15 min, was released, reports taking train and making bus t... Read more
altered mental status, pt was observed x 15 min, was released, reports taking train and making bus transfer and not remembering how he got home
64 2021-02-23 anxiety Patient experienced chest tightness and anxiety 5 minutes after vaccination. Onsite EMS was called v... Read more
Patient experienced chest tightness and anxiety 5 minutes after vaccination. Onsite EMS was called vitals are HR 89 BP 160/79 99% O2 room air. Patient went home.
64 2021-02-28 impaired work ability On day after receiving 2nd Covid vaccine, experienced chills, congestion, diarrhea and pain of right... Read more
On day after receiving 2nd Covid vaccine, experienced chills, congestion, diarrhea and pain of right arm., Unable to work. Seen by Concentra provider on 2/26/21. On 3/1/21, still feeling ill, unable to come to work.
64 2021-03-01 emotional distress 1-25-2021- Phone call: pt had cold and cough prior to vaccine. cough worsened 1-28-2021 Phone call: ... Read more
1-25-2021- Phone call: pt had cold and cough prior to vaccine. cough worsened 1-28-2021 Phone call: pt requesting provider visit, cough is same and taking tessalon pearls 1-29-2021 Provider in office visit: pt complain of cough and SOB for 6 days. Getting worse. Temp 101.2, pulse ox 87%, BP 128/70. level of distress- leaning forward to breath. appeared ill. diffuse rales throughout both lung fields, more at bases. Diagnosis Pneumonia due to COVID 19 virus. Sent to ER
64 2021-03-03 anxiety fatigue,headache, runny nose, dry nose, irtchy eyes, achy joints, anxiety
64 2021-03-06 poor quality sleep Next day about 11 am, began fatigue, chills, low grade fever. 99.8 to 100.3 slept most of the day. V... Read more
Next day about 11 am, began fatigue, chills, low grade fever. 99.8 to 100.3 slept most of the day. Vaccine sight was sore but no more than expected. All side effects have subside by this morning as I got up. Still tired but had a poor nights sleep with an episode of heavy sweating. Feeling fine now..
64 2021-03-07 impaired work ability pt stated that evening after getting the covid vax he started getting a pain like a cramp that start... Read more
pt stated that evening after getting the covid vax he started getting a pain like a cramp that started in the left buttock and hip that went all of the way down the outside of his leg. Pt went to ER on 3/5/2021 in early am since was having problems breathing and very nauseated. His back and legs were still hurting. He was given something for pain and nausea. Blood Pressure was elevated. They did blood work and chest X-ray with normal results. He was observed for about an hour and then discharged since nothing was found and told him he had a reaction to the vaccine. Pt still has constant pain in left leg and has not been able to work. Pt has an appt w/ PCP on 3/12 for FU.
64 2021-03-08 feeling abnormal Extreme Physical fatigue/Chills on second day(Friday) Saturday apprx 3A, like the rain stopping, ... Read more
Extreme Physical fatigue/Chills on second day(Friday) Saturday apprx 3A, like the rain stopping, I felt better. Some "Brain Fog" exists for next 5 days and continues.
64 2021-03-11 sleep disorder I was awakened with severe chills,runny nose,hot head,nausea,short of breath,unable to walk because ... Read more
I was awakened with severe chills,runny nose,hot head,nausea,short of breath,unable to walk because of severe shaking,blurred vision,slight headache,exhaustion
64 2021-03-12 insomnia Headache, stomach indigestion, aches and chills, fever (101F), insomnia.
64 2021-03-13 insomnia I normally have an a1c value of 5.9 My blood sugar went up to 275 and I had to take triple the amoun... Read more
I normally have an a1c value of 5.9 My blood sugar went up to 275 and I had to take triple the amount of insulin to bring it down. My blood sugar is still elevated 1 week after the shot, although not at 275 now. Headaches and sleeplessness
64 2021-03-16 panic attack High heart rate/panic attack. Patient reported feeling high blood pressure and panic after 10 minute... Read more
High heart rate/panic attack. Patient reported feeling high blood pressure and panic after 10 minutes of administration. Upon talking to patient and monitoring patient for an additional 20 minutes heart rate was at 70 and patient was feeling better and felt good enough to leave with his adult children for lunch. Water, deep breathing, and time were the only treatments administered, no epinephrine or diphenhydramine were administered. Followed up with the patient later that day, approximately 4 hours later and he was felling better. During monitoring patient did mention that he had a similar reaction to Miralax in the past but not Go Litely. Upon looking at the screening form this was not noted in the allergy field. This patient may have a concentration dependent sensitivity to polyethylene glycol, suspending agent or major component in the moderna vaccine is not diluted in any volume. Talked to supervisor to add a potential field of propylene glycol for the screening from.
64 2021-03-21 disorientation Upon waking on the third day after receiving the second dose of the Moderna vaccine, I've experienc... Read more
Upon waking on the third day after receiving the second dose of the Moderna vaccine, I've experienced vertigo/disorientation. This side effect has continued a second day causing me to notify my primary care provider and preparing this event report. Other side effects experienced after the second vaccination were soreness at the injection sight, mild fatigue, and slight fever which were all anticipated. These side effects have passed.
64 2021-03-25 anxiety patient was anxious before the vaccination. after vaccination, he wanted walk around then sit. he ... Read more
patient was anxious before the vaccination. after vaccination, he wanted walk around then sit. he sat on the floor and was stating that he had a phobia to needles/shots. he passed out briefly and came to shortly afterwards. 911 called, very low bp. patient and wife were moved to ambulance where patient eventually felt better and was able to walk. patient and wife did not want to go to hospital. we called him later to check on patient, he said he was feeling much better.
64 2021-03-26 feeling abnormal On 03/26/21 received my shot and about 20 minutes later i started to have side effects. My lower bac... Read more
On 03/26/21 received my shot and about 20 minutes later i started to have side effects. My lower back started to hurt, a bad taste came into my mouth, I started to feel woozy like i was looking through a glass gallon jar. A PA came in and took my blood pressure which was very high for me. I walked around for awhile and felt a little better. Took a trip to to pick up a Discharged patient but had to stop several times because my heart was racing causing me to start sweating. On 03/27/21 around 02;30 am i woke up to a left arm swollen down to my finger tips. Both of my legs had severe muscle cramps in the upper and lower muscles. It took 2 hours to come out of that. My leg strength was almost gone and now I had a severe pain in the ball of my left foot. The site were I had to shot was burning like it had been branded. I had brain fog couldn't remember what i was doing up. Though I had no breathing problems I was sweating like I had a bad fever. I noticed also that my vision became light sensitive! It was hard to watch the tv with the screen light which looked too bright to me. The site on my left arm were I strained the muscle hauling 70 lb sandbags became a very sensitive area. the swelling on my left hand was so bad I had to put lotion on the creases to relieve the stretching pain I felt. The headaches are a constant now even with my ears starting to ache too. Also the my eyebrow hair was very sensitive to touch. Had to go to the bathroom a couple of times but not as much as i thought I would. Both shoulder blades are constantly aching like my left hand fingers.
64 2021-03-26 insomnia Vaccine side effects included fever, headache, cough, dry throat, muscle pain, joint pain, gastroint... Read more
Vaccine side effects included fever, headache, cough, dry throat, muscle pain, joint pain, gastrointestinal distress, abdominal pain, insomnia, arm pain, sweating, chills.
64 2021-03-27 loss of personal independence in daily activities Extreme dizziness. Felt a bit clouded in the first 24 hours after the second shot of Moderna's Covi... Read more
Extreme dizziness. Felt a bit clouded in the first 24 hours after the second shot of Moderna's Covid vaccine. The morning of the second day I woke up extremely dizzy. Hard to get up. Still experiencing dizziness. By dizziness I mean "Disequilibrium relates to a feeling of unsteadiness or impending fall. " Again, this is after the second shot Lot information above is for second shot Lot # for first shot was 012A21A
64 2021-03-28 feeling abnormal left arm and hand swelling, heart racing and sweaty, brain fog, light sensitivity
64 2021-03-29 insomnia Shakeing, tiredness, sleepiness
64 2021-03-31 hallucination, confusional state 6:30 am next day after vaccine, patient developed hallucinations and became confused. Lasted till 1... Read more
6:30 am next day after vaccine, patient developed hallucinations and became confused. Lasted till 1 pm and then patient returned to normal with no other episodes. Patient and ex wife state that patient has had these episodes before when he had VRE and do not feel related to vaccine.
64 2021-04-02 impaired work ability moderate fever & head ache; fatigue; unable to work the day after the vaccination
64 2021-04-10 abnormal behaviour chills nausea difficulty functioning normally
64 2021-04-10 confusional state Patient sat in waiting area chair after receiving vaccine. I was notified by another customer that s... Read more
Patient sat in waiting area chair after receiving vaccine. I was notified by another customer that something appeared wrong with the patient. I went to the patient and found him unconscious and unresponsive. I told the technician to call 911 for EMS and I proceeded to remove the Epinephrine emergency pen from the emergency bag. The patient regained consciousness, I did not administer the epinephrine emergency pen. I remained with the patient. The patient complained of feeling hot, nausea and tired. Patient also appeared confused. Patient's head was cold to the touch. EMS arrived and took the patient's vital signs. The patient's awareness and tiredness appeared to vary from feeling fine and alert to confusion. After about 15 minutes with EMS the patient choose to go with EMS to the Hospital Emergency room for observation. The patient walked about 15 steps then chose to go on the gurney with EMS.
64 2021-04-10 disturbance in attention Chills without fever, Slight Nausea, Dizziness, Lack of concentration. Aches and pains, exhaustion.
64 2021-04-10 sleep disorder very stiff neck lasting from 4/8 to present 4/11 cannot move neck..hard to sleep very painful
64 2021-04-11 irritability, anger Escalating fatigue. Joint pain. Muscle aches. Headaches. Irritablity/anger. Intermittent nausea.
64 2021-04-12 abnormal behaviour 3/5/21 second dose of moderna vacc 3/6/21 fatigue & constitutional sx 3/7/21 aphasia and bazaar beha... Read more
3/5/21 second dose of moderna vacc 3/6/21 fatigue & constitutional sx 3/7/21 aphasia and bazaar behavior
64 2021-04-13 loss of personal independence in daily activities itchy rash appearing to be allergic in nature, resembling eczema/hives with welts and scaling lastin... Read more
itchy rash appearing to be allergic in nature, resembling eczema/hives with welts and scaling lasting for at time of reporting 4 weeks and requiring medical attention, course of steroids prescribed patient also describes overwhelming fatigue, muscle fatigue and significantly diminished ability to perform daily activities/work, partially resolved but still present/recurring
64 2021-04-13 sleep disorder 9 hours later and continuing through the next day: Fever, chills, headache, body aches, could not sl... Read more
9 hours later and continuing through the next day: Fever, chills, headache, body aches, could not sleep
64 2021-04-15 disorientation Received vaccine approx 11:20am, no issues until 10:30pm when I started to feel chilled. I took my t... Read more
Received vaccine approx 11:20am, no issues until 10:30pm when I started to feel chilled. I took my temp with a forehead thermometer and it read 98.x. I put the thermometer on my nightstand thinking it prudent to have it handy. In bed under covers I kept feeling cold and started shivering/teeth chattering, within an hour or so my forehead thermometer read 102. My recollection of the time between midnight and 2 to 3am is vague as I was very disoriented, I recall taking my forehead temp several times during those hours - that took a lot of effort, and I saw several readings of 105 and I believe one over 106. I remember thinking I should be in the ER, then thinking how could I get there, then thinking I would call 911 but that I could probably not get my mind/body to be able to physically make a phone call. I believe that during this time span I had brief periods of consciousness when I was somewhat aware that I was having a high fever event, but that there wasn't much I could do about it (I live alone). By 4am I was more aware, forehead temp reading was 102.something - I got up and made my way to the kitchen, I was unsteady on my feet and remember telling myself to be careful and not to fall. Temp gradually dropped throughout Tuesday, mostly back to normal on Wed.
64 2021-04-15 feeling abnormal First dose received 3/17/2021. First two days I had muscle aches. Third day, lack of coordination ... Read more
First dose received 3/17/2021. First two days I had muscle aches. Third day, lack of coordination and fatigue. Fourth day also had chills, sneezing and runny nose. Brain fog, fatigue and lack of coordination improved over the following days. The second dose receive 4/13. First day fatigure, chills, lack of coordination and muscle aches along with a lot of soreness at the site of the injection. Second day also had dizziness, mild abdominal cramps and mild headache. Could not eat until midday. The third day dizziness, brain fog and lack of coordination continue. Close to a point of seeking medical care but probably worth filing a report.
64 2021-04-15 impaired work ability, disturbance in attention, excessive sleepiness HAD A MILD HEADACHE + LOW 98.8 TEMP + EXHAUSTED (HAD TO SLEEP) BEGAN EARLY 4/14 - WORKED UNTIL NOON,... Read more
HAD A MILD HEADACHE + LOW 98.8 TEMP + EXHAUSTED (HAD TO SLEEP) BEGAN EARLY 4/14 - WORKED UNTIL NOON, TOOK NAP IN OFFICE, THEN LEFT FO THE DAY. COULD NOT CONCENTRATE. HOME & SLEPT TILL 5 PM, BROKE OUT IN COLD SWEAT. FELT OK FOR SHORT PERIOD, THEN MILD HEADACHE + TEMP RETURNED, CREATING FEELING OF EXHAUSTION. SLEPT MORE. IN BED BY 930. WAS WOKEN AT 330 AM BY COLD SWEAT. FEVER BROKE AGAIN. FELL BACK TO SLEEP, SELPT TILL 330. COULD NOT WORK. TODAY SOME WHAT TIRED BUT FEELING BETTER
64 2021-04-19 mental status changes Anaphylaxis (SOB, throat closing, wheezing, tachycardia, change in mentation over 10 minutes) Given ... Read more
Anaphylaxis (SOB, throat closing, wheezing, tachycardia, change in mentation over 10 minutes) Given Epi-Pen and Benadryl, Transported via EMT to ER
64 2021-04-20 feeling abnormal pale, clammy, sweating, lightheadness, possible absence seizure after 2nd shot. He waited his 15 min... Read more
pale, clammy, sweating, lightheadness, possible absence seizure after 2nd shot. He waited his 15 minutes, and was waiting on his wife's 15 minutes, when he started to feel badly. Ambulance came to make sure he didnt have a seizure and his vitals were okay. patient said he had not eaten before shot and walked to a nearby restaurant to eat.
64 2021-04-21 feeling abnormal HEADACHE, STIFF NECK, CHILLS OF SHORT DURATION, LEADING TO IMBALANCE, FINE TREMORS, SEVERE "HEAD FO... Read more
HEADACHE, STIFF NECK, CHILLS OF SHORT DURATION, LEADING TO IMBALANCE, FINE TREMORS, SEVERE "HEAD FOG", DYSPHAGIA,
64 2021-04-21 insomnia Fri 4-16-21 The night after receiving the second dose had mild insomnia so was a little tired the n... Read more
Fri 4-16-21 The night after receiving the second dose had mild insomnia so was a little tired the next day (Sat). Sat 4-17-21 Sat night I had to get up 4 times to urinate. This never happens to me. I never have to get up in the middle of the night to urinate. Sun 4-18-21 Back to normal
64 2021-04-22 loss of personal independence in daily activities Low grade fever, chills, bilateral hip pain/stiffness, left arm pain/stiffness. Symptoms still occ... Read more
Low grade fever, chills, bilateral hip pain/stiffness, left arm pain/stiffness. Symptoms still occurring 16 days after second injection. I usually hiked 5-10 miles/day prior to vaccination. Now I hike 5 minutes and have to rest due to fatigue and hip pain. Have difficulty using left arm due to shoulder pain stiffness.
64 2021-04-26 feeling abnormal, loss of personal independence in daily activities pt states today , april 27/2021 is the first day he has been able to get out of bed and dress for th... Read more
pt states today , april 27/2021 is the first day he has been able to get out of bed and dress for the day; symptoms started the morning after receiving shot which was april 14/2021, states body aches, chills and sweats (never took his temperature states he has not thermometer), no appetite but has been drinking, got up only to go to the bathroom; states he still feels lousy
64 2021-04-26 feeling abnormal I felt awful like never before in my life. This lasted 3 1/2 days. Joint pain, aches, fever, naus... Read more
I felt awful like never before in my life. This lasted 3 1/2 days. Joint pain, aches, fever, nausea, vomiting and extreme fatigue. My family thought I had actually gotten COVID. Still having reflux issues and not at 100% strength.
64 2021-04-30 loss of personal independence in daily activities Mil headache, muscle joint pain and Vertigo like symptoms that have lasted 1 week so far. The dizzin... Read more
Mil headache, muscle joint pain and Vertigo like symptoms that have lasted 1 week so far. The dizziness is coupled with nausea depending on my activity. I was unable to do much at all because of the severity of this. I will not take another vaccine no matter what. Being this sick is ridiculous, I will take my chances.
64 2021-05-03 feeling abnormal, memory impairment It has been one week since the injection. I continue to have moderate/hi tinnitus. I continue to h... Read more
It has been one week since the injection. I continue to have moderate/hi tinnitus. I continue to have memory problems, thinking challenges, edgy, low grade headache, 'numbiness' of the brain, 'hollowness' of the brain. I feel like the chemicals of my brain have been significantly impacted. The severity of the symptoms are 99% leaning me not to have the second vaccine injection.
64 2021-05-03 insomnia Right arm ache 5 hour after inject. By 12 hours, unable to sleep. 24 hour after inject fever 101-1... Read more
Right arm ache 5 hour after inject. By 12 hours, unable to sleep. 24 hour after inject fever 101-102. Headache. Stiff neck. 72 hour after inject - fever gone, neck minor ache, arm mobile with minor residual pain, headache gone. Shoulder pain similar to dislocating shoulder (done 10 years ago).N
64 2021-05-04 mental status changes, confusional state Dizziness, palpitations and not feeling well followed by confusion/altered mental status, chills and... Read more
Dizziness, palpitations and not feeling well followed by confusion/altered mental status, chills and weakness 4 days later. Presented to medical center with bacteremia & hypotension on 4/26 PM. Transferred to same medical center on 4/29 with concerns for myasthenia crisis.
64 2021-05-05 hallucination The injection went smoothly. No bleeding or pain. Several hours later, at the beginning of my sleep,... Read more
The injection went smoothly. No bleeding or pain. Several hours later, at the beginning of my sleep, estimated around 11pm, I started hallucinating. I felt my eyes were closed but could see colored curtains. These curtains kept staying in my view and after a short time they woulld change to a different set and color. The feeling was a new one for me. I even spoke to my wife and told her I was hallucinating! Fortunately, it was over relatively quickly, and did not happen again. Since I had not read/heard about hallucination as one of possible side effects, I thought I should report this. Thus, this has not required my PCP's involvement, although I'll inform him next visit.
64 2021-05-07 loss of personal independence in daily activities, sleep disorder Weakness in upper legs, pain in knees and thighs, typically will occur after sitting or laying down,... Read more
Weakness in upper legs, pain in knees and thighs, typically will occur after sitting or laying down, During nighttime pain will wake me and become severe while attempting to roll over on my side. Sometimes it is difficult to stand from a sitting position and once I do obtain a vertical position, baby steps are required until my legs are loosened up. This pain seams to come and go, one day the pain level will be a 2 and the next a 5 with no reason, I have been minimizing activities to provide rest for it, but it does not seam to be doing any better.
64 2021-05-09 abnormal behaviour, delirium Felt sore all over; Mild temperature of 100.4 F; Delirious; Soreness of arm; Talking out of his head... Read more
Felt sore all over; Mild temperature of 100.4 F; Delirious; Soreness of arm; Talking out of his head; Shaking; Was very cold; Got real hot; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirious) in a 64-year-old male 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. The patient's past medical history included COVID-19 (Reports that the patient had done regeneron infusion on 02 Feb 2021). On 27-Apr-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced DELIRIUM (Delirious) (seriousness criterion medically significant), PAIN IN EXTREMITY (Soreness of arm), ABNORMAL BEHAVIOUR (Talking out of his head), TREMOR (Shaking), FEELING COLD (Was very cold) and FEELING HOT (Got real hot). On 27-Apr-2021 at 11:00 PM, the patient experienced PYREXIA (Mild temperature of 100.4 F). On 28-Apr-2021, the patient experienced MYALGIA (Felt sore all over). At the time of the report, DELIRIUM (Delirious), PAIN IN EXTREMITY (Soreness of arm), ABNORMAL BEHAVIOUR (Talking out of his head), TREMOR (Shaking), FEELING COLD (Was very cold), FEELING HOT (Got real hot), PYREXIA (Mild temperature of 100.4 F) and MYALGIA (Felt sore all over) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 100.4 Mild temperature of 100.4 F was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details included the use of acetaminophen.; 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.
64 2021-05-09 disturbance in attention Fairly strong injection site pain for several days (unusual for me as I normally have no problems wi... Read more
Fairly strong injection site pain for several days (unusual for me as I normally have no problems with past vaccines). 102.8 fever 12hrs after 2nd dose. Severe chills/shaking. Fever dropped to slightly over 100 from dose plus 17hrs through 63hrs, prior to dropping rapidly to normal. During duration of fever: headache, muscle aches, digestive tract gas and loose stools, weakness, lack of mental focus, tired, and general feeling of heaviness with some feeling of heart palpitations (not normal for me). Post fever, minor headache, weakness, and lack of mental focus continued through present (Dose plus 80hrs), but now almost totally gone. Appear to be starting Moderna/COVID arm with 4in diameter, round, itchy red spot on just at and below injection site on right bicep.
64 2021-05-09 excessive sleepiness Headache, Nausea, Hot Temperature (sweating profusely), coughing (damage to chest), body aches, leth... Read more
Headache, Nausea, Hot Temperature (sweating profusely), coughing (damage to chest), body aches, lethargic, sleeping 16 hours, blurriness, large amount of mucus. Tired, results similar to pnumonia.
64 2021-05-09 mental impairment I got my first shot actually felt better but the second shot my arm got very sore around the injecti... Read more
I got my first shot actually felt better but the second shot my arm got very sore around the injection site and then I got deathly sick throwing up for around 8 to 12 hours got very week and dizzy headed and also messed my mind up to where I couldn't think right couldn't hardly walk had to hold onto the wall which I have some problems walking already but that made walking much much more difficult and after that started to feel better and so far I'm still feeling better just wanted to let you know how it done me to see if anyone else has or had any of these symptoms
64 2021-05-09 restlessness, insomnia The next morning (exact time was estimated) patient complained he didn't feel good. His symptoms inc... Read more
The next morning (exact time was estimated) patient complained he didn't feel good. His symptoms increased to the point of his believing he has Covid again (with the exception of taste and smell); ie: restlessness; fever (off and on); extreme fatigue; coughing; labored breathing; loss of appetite; and difficulty sleeping. He already had Covid-19 and was hospilized over a week and returned home with oxygen and at-home treatment.
64 2021-05-12 altered state of consciousness MYSTERY "STROKE": The patient remembers receiving the MODERNA COVID vaccination and feeling nothing... Read more
MYSTERY "STROKE": The patient remembers receiving the MODERNA COVID vaccination and feeling nothing immediately after shot, took off work a few days later and then on following Monday remembered getting up and preparing for day with shave and shower. Remembers blood sugar being in normal range. Went to dress and collapsed. Could not move left side of body or cry out for help. Was found by a neighbor after two days of being face down on floor unable to reach phone drifting in an out of consciousness. Transported by EMT to hospital. MRI brain scan, ultrasound of legs including Doppler velocimetry conducted. Now at healthcare facility. Continued weakness left side.
64 2021-05-17 sleep disorder Symptoms are variable but some combination troubles me every day since March 6, excepting the twelve... Read more
Symptoms are variable but some combination troubles me every day since March 6, excepting the twelve days I was on the Prednisone prescription. In general, pain increases during sleeping hours, when I grow stiff and less flexible. I wake several times during the night (almost hourly) dry-mouthed. I don't know if pain wakes me or not. I rise with great difficulty and hobble to the bathroom. Mornings are the worst part of the day, but I find if I keep moving, I loosen up and the general inflexibility goes away, and to some degree, so does the pain. It is never entirely gone. I also find that the pain seems to generally occur during movement and not at rest, although the pelvic pain and upper leg pain has and does occur while at rest. The most regularly-occuring pain is hamstring and shoulder (shot locations). Rising from a laying or seated position has always been the most difficult. Lately, pelvic pain has been rare, and knee pain intermittent.
64 2021-05-18 confusional state, disorientation 30 minutes after the shot, patient was driving home and was disoriented and confused. He pulled his ... Read more
30 minutes after the shot, patient was driving home and was disoriented and confused. He pulled his car over and said he sat there for 60 minutes. After an hour he said he felt fine and back to normal and was fine since.
64 2021-05-21 feeling abnormal extreme headaches chills and fever 36 hours thought i was dying
64 2021-05-26 confusional state Confusion. Didn't know where I was driving home. Massive body aches and headaches.
64 2021-05-26 feeling abnormal, confusional state, sleep disorder, memory impairment confusion, didnt know where i was driving home. fever, headaches and body aches feet and hands numb... Read more
confusion, didnt know where i was driving home. fever, headaches and body aches feet and hands numb brain fog memory issues. very very tired super weak ... second shot, same but with added lower back pain and leg cramps. massive headache, went to the doc, he told me that first event was a stroke. now i have a blockage carotid left side in my neck. sent me for ultra sound them ct scan. waiting to see vascular doc after discovery 80% blockage. sill very tired very weak. brain fog, hands going numb eye sight weaker. bad smell in my nose sometimes., not sleeping well. short of breathe.
64 2021-05-31 feeling abnormal 2nd Vaccine, April 29, Thursday ~5 pm had 2nd COVID vaccine, Lot# 045B21A; April 30, Friday, Feeling... Read more
2nd Vaccine, April 29, Thursday ~5 pm had 2nd COVID vaccine, Lot# 045B21A; April 30, Friday, Feeling very achy and sore muscles, feeling achy more quickly than 1st vaccine. Spent day in bed. April 31, Saturday, Feeling terrible, just as bad as worse part of COVID 19, achy and sore with fever. Spent day in bed. May 1, Sunday, still achy and sore, but feeling better. No fever, up and around some. May 2, Monday, returned to work. Tired but OK, feeling a little "Spacey"
64 2021-05-31 feeling abnormal 1st Vaccine, April 1, Thursday ~5 pm had 1st Moderna vaccine, Lot# 021B21A April 2, Friday, During t... Read more
1st Vaccine, April 1, Thursday ~5 pm had 1st Moderna vaccine, Lot# 021B21A April 2, Friday, During the day felt tired, by the end of the day very tired and achy, went to to bed early. April 3, Saturday, Felt just as bad as when I had Covid 19, stayed in bed all day, slight fever. April 4, Sunday, Aches not as bad, no fever, up and around some. April 5, Monday, Returned to work
64 2021-06-03 confusional state, disturbance in attention, feeling abnormal, memory impairment feeling of mentally slow, fuzzy, or spaced out. lack of mental clarity. memory problems, poor concen... Read more
feeling of mentally slow, fuzzy, or spaced out. lack of mental clarity. memory problems, poor concentration. headache. confusion. hard to write clearly. tired, hand to mouth movement odd at times.
64 2021-06-07 feeling abnormal The next day, I started to feel really weird. I had no energy and my head felt really strange. About... Read more
The next day, I started to feel really weird. I had no energy and my head felt really strange. About a week and a half later, around 5am, the left side of my body started going numb. My wife took me to the ER. My BP was super high. About 6 hours later, the numbness started to go away. They performed various tests, but couldn't find anything wrong. They think I had a TIA, which is a blood clot that resolves itself. For the following month or so, I was just extremely tired and felt really crappy.
64 2021-06-09 loss of personal independence in daily activities I have had a Slight headach since my second shot. Fast head movement or blood pressure increase from... Read more
I have had a Slight headach since my second shot. Fast head movement or blood pressure increase from workouting causes pain to the front right loeb. Brain Swelling? Doctor gave me MethyLPEDNISolone 6 days. I day 3 80% of the pain/ issues seem to decrease. Felt better/ I was able to workout. Few days after treatment I am back to the same head pain.
64 2021-06-20 sleep disorder Client stated that his arm, that had the injection in, has been extremely sore off and on for a mont... Read more
Client stated that his arm, that had the injection in, has been extremely sore off and on for a month. Client stated that he could not lay on the arm for about 3 weeks.
64 2021-06-22 impaired work ability no interest in work; Hypersensitive; No appetite; Put me in bed; Passed out, thought I was gone; Thi... Read more
no interest in work; Hypersensitive; No appetite; Put me in bed; Passed out, thought I was gone; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included DEXTROAMPHETAMINE [DEXAMFETAMINE], CLONAZEPAM (CLONAPIN), TEMAZEPAM and OMEPRAZOLE 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 01-Apr-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) (seriousness criterion medically significant). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (no interest in work), HYPERSENSITIVITY (Hypersensitive), DECREASED APPETITE (No appetite) and BEDRIDDEN (Put me in bed). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at a dose of UNK dosage form. On 02-Apr-2021 at 3:15 AM, LOSS OF CONSCIOUSNESS (Passed out, thought I was gone) had resolved. At the time of the report, IMPAIRED WORK ABILITY (no interest in work), HYPERSENSITIVITY (Hypersensitive), DECREASED APPETITE (No appetite) and BEDRIDDEN (Put me in bed) outcome was unknown. It was reported that after the 2nd dose, within 75 min, the patient passed out after going home until 3:15AM the next morning (02Apr2021). The patient reported that the nurse at the vaccinating facility, after checking with the Doctor gave the 2nd dose in spite of the patient's concern (he was feeling sick on that day) if he needs to wait for the 2nd shot. The patient stated he made a terrible mistake getting the 2nd shot while still sick from the 1st shot. He is going for lab tests the next Monday (14 Jun 2021). Other treatment information include more amount water. 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-2021-218564 (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 2021-06-22 sleep disorder In March IBS started which I?ve never had before. Everything I ate turned into what felt like rocks ... Read more
In March IBS started which I?ve never had before. Everything I ate turned into what felt like rocks , I got so constipated I couldn?t use the bathroom. I started to become nauseated every day. I was up every hour of the night. I tried drinking water to flush my body and stomach, I had trouble eating. I ended up losing 3lbs a week up to 20 lbs. total. I ended up in ER on March 17, 2021. I had to be wheeled in because I was so weak, I couldn?t walk. I had CT scans and bloodwork done. I was sent home after I had a bowel movement. I was also given laxative to take at home. I went to the ER again on 4/23/21 @ 5pm ( 2nd ER visit ) I had CT Scans with contrast, enema, and lab work. I was also hooked up to an IV. I had no blockages from CT Scan. The CT Scan showed impaction, I had to drink stuff in ER to flush system and was given another enema. Once I had a bowel movement I was released with laxative. I now take generic brand laxative and generic brand of medication every day. I was advised that it could take my intestines a long time to return to normal. After following up with doctor, he decided I needed to have a scope done on my lower GI. I am still having complications.
64 2021-06-30 feeling abnormal PATIENT STATED THAT HE THINKS THAT HE HAD A COUPLE OF SEIZURES. FELT BAD FOR SEVERAL DAYS.
64 2021-07-26 panic attack PATIENT WAS NERVOUS RIGHT BEFORE IMMUNIZATION. HE COMPLAINED OF DRY MOUTH AND WANTED GLASS OF WATER... Read more
PATIENT WAS NERVOUS RIGHT BEFORE IMMUNIZATION. HE COMPLAINED OF DRY MOUTH AND WANTED GLASS OF WATER. AFTER WATER SAID HE WAS OK FOR SHOT. I DID SHOT AND HE SAID IT WAS GOOD. HE CHOSE TO STAY IN IMMUNIZATION AREA. ABOUT 5 MINUTES LATER, HE TOLD TECHNICIAN HE WAS FEELING LIGHT HEADED AND HE LAYED DOWN. I VISUALLY ASSESSED HIM, HIS FACE WAS RED BUT HE WAS BREATHING NORMALLY. I ASKED IF HE COULD SPEAK AND HE RESPONDED VOCALLY. HE ASKED FOR 911 TO BE CALLED. I CALLED 911 AND STORE MANAGEMENT. STORE MANAGER BROUGHT HIM WATER TO DRINK. AFTER CALL, I CHECKED ON HIM. HE WAS SITTING UP AND FACE COLOR WAS IMPROVED. I ASKED HIM TO SIT COMFORTABLY AND WAIT FOR EMT TO ARRIVE. THEY ARRIVED A 5 MINUTES LATER AND ASSESSED, TOOK BP AND VITALS. AFTER DISCUSSING WITH THEM, PATIENT SAID HE HAD A PANIC ATTACK FROM SHOT. HE DECLINED TO BE TAKEN TO HOSPITAL. EMT SIGNED HIM OFF AND STARTED PACKING UP. PT LEFT UNDER HIS OWN POWER
64 2021-07-27 feeling abnormal Hide copied text Hover for details FINAL IMPRESSION 1. Adverse effect of COVID-19 vaccine 2. Hypok... Read more
Hide copied text Hover for details FINAL IMPRESSION 1. Adverse effect of COVID-19 vaccine 2. Hypokalemia 3. Acute alcoholic gastritis without hemorrhage PLAN New Prescriptions FAMOTIDINE (PEPCID) 20 MG TABLET Take 1 tablet by mouth 2 times daily. ONDANSETRON (ZOFRAN) 8 MG TABLET Take 1 tablet by mouth every 8 hours as needed for Nausea. Discharge Instructions I do suspect that part of your feeling poorly is from the Covid vaccine. However you are difficult situation also makes you quite vulnerable to feeling fatigued and worn out. The alcohol I am afraid is really bothering your stomach. Please cut down the wine as much as possible. I am afraid you are starting to irritate the lining of your stomach. I put you on an acid blocking medication given you something for nausea.
64 2021-07-28 anxiety, feeling abnormal, panic attack Lightheaded (in a fog) jitters, difficultly breathing (Asthma attacks) , Anxiety (had several panic... Read more
Lightheaded (in a fog) jitters, difficultly breathing (Asthma attacks) , Anxiety (had several panic attacks), headaches . The side effects lasted several weeks but have tapered off I continue to deal with difficultly breathing and anxiety. I did get a second vaccination (Moderna OU7B21A) on 5/24/21. with the same but more intense side effects, which caused me to visit my general practitioner.
65 2021-01-13 confusional state Pain at injection site, chills, fever, extreme fatigue, sleepy, and confusion
65 2021-01-24 abnormal behaviour Patient was tested positive for Covid-19 on 12/9/20. Patient received Covid Vaccine on 1/21/21. Pat... Read more
Patient was tested positive for Covid-19 on 12/9/20. Patient received Covid Vaccine on 1/21/21. Patient was observing for 15 minutes in treatment room by Nursing staff. Patient denied any signs/symptoms adverse effect: headache, dizziness & weakness, difficulty breathing, muscle pain, chills, nausea and vomiting, and fever . Patient seated on treatment table appeared to be relaxed, respiration even and unlabored. Health teaching provided. Patient educated to report any changes in condition to staff immediately. Patient verbalized understanding and able to verbalize signs and symptoms and adverse effects to be aware of related vaccine. On 1/22/21: patient was seen by medical provider for "altered behavior". Per medical provider's documentation: "Patient was fallen on 1/2/21 and was sent out to outside hospital on 1/4/21. CT head: no intracranial abnormality, age-related changes. Patient had labs (B12, RPR, folate) were within normal limit". We did MMSE today: 22/30 score "mild dementia" On 1/23/20: "Patient was inside his cell. He was walking towards cell door to obtain his breakfast, when custody witnessed him collapse and activated the alarm. Nursing staff arrived at cell front at 06:34 am and found the patient pulseless and unresponsive, and CPR was immediately initiated. AED was attached at 06:35 am and no shock advised. AMR then arrived and patient did not have ROSC, and was pronounced dead at 06:54 am."
65 2021-01-26 feeling abnormal Headache, Muscle aches, a "buzzy" feeling in the body, GI upset, brain fog, exhaustion upon arising ... Read more
Headache, Muscle aches, a "buzzy" feeling in the body, GI upset, brain fog, exhaustion upon arising and in the evenings. Soreness at injection site lasted 2 days, the other symptoms lasted four full days.
65 2021-01-28 feeling abnormal Vaccine taken on 1/20. 1/24 began symptoms of exhaustion, fatigue, headache and brain fog. 1/24 be... Read more
Vaccine taken on 1/20. 1/24 began symptoms of exhaustion, fatigue, headache and brain fog. 1/24 began additional symptoms of decrease /altered taste in mouth. symptoms last 3-4 days.
65 2021-02-10 sleep disorder Left knee Osgood Schlatter's disease sharp pain for 3 days, especially at night. Rec'd shot Saturda... Read more
Left knee Osgood Schlatter's disease sharp pain for 3 days, especially at night. Rec'd shot Saturday morning, pain started Sunday evening and ended Wednesday morning. Pain was enough that it woke me up Sunday, Monday and Tuesday nights. I treated the pain with ice and ibuprofen, but still very painful to move and to touch. Wednesday it got better about as quickly as it started on Sunday. I did not do any physical activity that would have triggered such sever pain. The only thing that was different is that I received the Moderna vaccine. By Thursday my knee was back to normal.
65 2021-02-11 impaired work ability Dizzy, sleepy, was at work and got sent home
65 2021-02-11 nightmare, insomnia First day: Upper body soreness beyond vaccination site, headache, sleeplessness; Second day: Physica... Read more
First day: Upper body soreness beyond vaccination site, headache, sleeplessness; Second day: Physical weakness, unable to regulate body temp (couldn't get warm), sleeplessness (woke up drenched in sweat); Third day: daytime felt ok. Nighttime had 3 intense nightmares back to back, with some sleep in between. ( I rarely have nightmares) Fourth day: Feeling better in general, but those nightmares scared the bejusus outta me.
65 2021-02-13 insomnia Moderna COVID-19 Vaccine EUA. First dose. Soreness in the arm that continued for 48 hours. Low grad... Read more
Moderna COVID-19 Vaccine EUA. First dose. Soreness in the arm that continued for 48 hours. Low grade fever for about 4-6 hours with occasional chills. Most significant adverse reaction was sleeplessness. It was like I was on a caffeine high. Did not even feel close to sleepy until 3:30 AM, about 12 hours after the shot. Normal bedtime is 10:30 pm.
65 2021-02-14 sleep disorder Began to experience UTI type symptoms, with uncharacteristically frequent urination, and some burnin... Read more
Began to experience UTI type symptoms, with uncharacteristically frequent urination, and some burning. Began to have a fever which over the 24 hour period went from my normal of 97.6 to 101.2 at 10:30pm the second night. Throughout the period I had a mild headache and significant fatigue. I woke up this morning at 12:30am with the sheets, pillow and pajamas very wet (from sweat). I checked my temperature and for the first time in 24 hours, it had dropped (to 99.2). When I got up at 6 this morning, my temperature was 98.6 (still a little elevated for me). My wife experienced practically the same thing 4 days earlier without the urinary symptoms and temp not quite a elevated. We had the vaccine at the same time(s). I'm still fairly fatigued at this time (and my wife a little).
65 2021-02-17 amnesia, confusional state, feeling abnormal, insomnia unconscious, near death experience; extreme headache while at work; felt like he was walking on wate... Read more
unconscious, near death experience; extreme headache while at work; felt like he was walking on water; couldn't eat; couldn't sleep; doesn't remember any of it; couldn't talk; speech was garbled; wasn't understanding or comprehending anything; difficulty breathing; fatigue; muscle pain all over his body; joint pain; chills; nausea; vomiting; he couldn't control his bladder; fever that went up really high; dizziness; Weakness; Two spontaneous cases were received on 02Feb2021 concerning a male patient, 65 years of age. The cases are cross-linked. The reporter stated the patient is their nephew. According to one report, the patient experienced the following symptoms: "extreme headache while at work", "felt like he was walking on water", "couldn't eat", "couldn't sleep", "doesn't remember any of it", "unconscious", "near death experience", "he couldn't talk and speech was garbled", "he wasn't understanding or comprehending anything". According to the other report, her nephew experienced symptoms immediately upon receiving the vaccine. She reported the following symptoms not already mentioned by the first reporter; "difficulty breathing", "chronic headache:, "fatigue", "muscle pain all over his body", "joint pain", "chills", "nausea", "some vomiting", "couldn't control his bladder", "fever that went up really high", " lost ability to breathe", "dizziness", "weakness", "Moderna shot is killing him", and "he is dying". The patient's prior medical history include an allergy to Shellfish, previously reported as fish allergy. No other medical history was provided and concomitant product use was not provided by either reports. Prior to the onset of events, the patient received his first of two planned doses of mRNA-1273, (date and batch number not provided), (injection site not provided), for prophylaxis of Covid-19 infection. On ??Jan-2021, shortly after receiving mRNA-1273 immunization, the patient began experiencing the following symptoms: "extreme headache while at work", "felt like he was walking on water", "couldn't eat", "couldn't sleep", "he couldn't talk and speech was garbled", "he wasn't understanding or comprehending anything". At an unknown time later he experienced "difficulty breathing", "lost consciousness" and was admitted to the hospital ICU on 22Jan-2021. Transport to hospital and name of hospital was not reported. According to the reporters the patient remained in the ICU for eleven days. The following symptoms were reported as occurring during his hospitalization either in the ICU or after transfer to a less acute unit on or about 01-Feb-2021: "chronic headache:, "fatigue", "muscle pain all over his body", "joint pain", "chills", "nausea", "some vomiting", "couldn't control his bladder", "fever that went up really high", " lost ability to breathe", "dizziness", "weakness", "dying", unconscious for almost a week". According to the reporters he had CT exams of spine and brain, and heart exams twice on different days while hospitalized but results "didn't find anything". No other significant results or details of his hospital stay were reported. As of the report date 02-Feb-2021 the patient remained hospitalized. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown. Company comment: The reported events, "loss of consciousness", "headache", "feeling abnormal", "weakness" "decreased appetite", "insomnia", "amnesia", " aphasia", "dysarthria", "confusional state", "dyspnea", "fatigue", " myalgia", "arthralgia", "chills", "nausea", "vomiting", " pyrexia", "urinary incontinence", and "dizziness" were possibly related to mRNA-1273.
65 2021-02-18 confusional state, disorientation, memory impairment 65 y.o. man was in excellent health until episode on 2/13. At 11:30 PM he drove from his home to do ... Read more
65 y.o. man was in excellent health until episode on 2/13. At 11:30 PM he drove from his home to do work in a cow barn. His wife joined him to help at about 12:15 AM and she found him to be disoriented and confused. He has no memory of what happened during the preceding 45 minutes. No indication of any fall or injury. He had no preceding medical problems. No medications. Had received his 1st Moderna COVID-19 vaccine at about 5:30 PM on 2/13. His wife took him to a local ER. No focal findings on neuro exam. His confusion gradually improved over the next 24-36 hours but he still can?t remember what happened at the beginning of the episode. Head CT revealed an incidental 6 mm colloid cyst in the 3rd ventricle. Transferred to Hospital for further evaluation and monitoring where seen by Neurosurg and Neurology. Had MRI and EEG. No arrhythmia on ECG or telemetry. Neurology felt the episode was due to transient global amnesia. Discharged on 2/16.
65 2021-02-18 disorientation * loss of balance, general feeling of disorientation. Staggering, accompanied by a flush feeling and... Read more
* loss of balance, general feeling of disorientation. Staggering, accompanied by a flush feeling and diaphoresis. This lasted about 10 minutes, then I returned to the chills, headache, and maliase.
65 2021-02-19 loss of personal independence in daily activities STARTING ON 16 FEB 2021 Through today (20 Feb). Bad flu symptoms. Headaches - from low to severe. ... Read more
STARTING ON 16 FEB 2021 Through today (20 Feb). Bad flu symptoms. Headaches - from low to severe. Body aches from low to severe. Joint aches from low to severe. Severe chills. Severe sweating - soaking the bed nightly. Fever - Tends to be lower in AM - 99.0. During afternoon and night 102.5. Unable to perform any normal daily work or activities.
65 2021-02-21 anxiety, panic reaction I am allergic to polyethylene glycol ? it actually put me in the hospital for years ago. I had no i... Read more
I am allergic to polyethylene glycol ? it actually put me in the hospital for years ago. I had no idea it was in the vaccine, although a smaller amount than I had taken before. I started experiencing severe and awful anxiety and panic that night I got the vaccine. I had other minor side effects that were expected but they went away within a day. Several days later, I began experiencing pain in both my bilateral Achilles tendons and bilateral knee pain. A physical therapist examined both and said that I was swollen. I have had both of those problems under control for a very long time. I am improving somewhat but nearly 2 weeks later I am still having some repercussions. I am now scared and don't know if I should get the second injection done because the previous adverse symptoms were awful. Thank you.
65 2021-02-21 loss of personal independence in daily activities Nausea, muscle ache, chills, arm soreness and head ache. I would describe my symptoms as serious, n... Read more
Nausea, muscle ache, chills, arm soreness and head ache. I would describe my symptoms as serious, not mild or moderate. I felt that I was extremely ill for the first 45 hours. I ate very little and I could not bathe. I stayed in bed, leaving only to go to the restroom. On the 3rd day, I was much improved and I would characterize my symptoms as moderate. I was able to get up for short periods and I was also able to bathe. On the 4th day (today) I believe that I am symptom free with the exception of continued arm soreness at the injection sight.
65 2021-02-23 sleep disorder Woke to profound chills and shaking despite no appreciable moisture present on skin. This subsided i... Read more
Woke to profound chills and shaking despite no appreciable moisture present on skin. This subsided in appx. 30 minutes however I suffered a very poor night?s sleep. Following day, Feb 20, 2012, I felt as though I had a very mild virus with achiness in neck and shoulders primarily with lesser discomfort in back and legs. Was a mildly fatigued with mild headache as well. Did not check temp but never felt feverish. On 2/21/2021 I felt symptom free until evening when a slight trace of achiness returned. I slept very well that night and woke symptom free, encountering no further reactive symptoms.
65 2021-02-27 feeling abnormal 18 hrs. after injection I started to feel off, 24 hrs. after injection I was very tired, ached all ... Read more
18 hrs. after injection I started to feel off, 24 hrs. after injection I was very tired, ached all over and started to run a fever, took a 3 hr. nap in the afternoon. Ended up going to bed very early that evening (7:30) I woke up in the middle of the night covered in sweat, a fever of 101.4 degrees. I woke up at 10:00am the next day still running a fever but on 99.4 but still ackey and tired throughout the whole day. I took a short nap in the afternoon. I woke on the 3rd day after my shot and all I have now is a little soreness in my armpits, fatigue and aches are gone.
65 2021-02-27 insomnia Chills, Sweats, Low Grade Fever, Dizziness, Shakes, very bad injection site pain. Blurry vision, tr... Read more
Chills, Sweats, Low Grade Fever, Dizziness, Shakes, very bad injection site pain. Blurry vision, trouble sleeping.
65 2021-02-28 excessive sleepiness, confusional state, disturbance in attention, insomnia Feeling of exhaustion, increasing over the next few days.. Need for enormous amount of sleep, incl... Read more
Feeling of exhaustion, increasing over the next few days.. Need for enormous amount of sleep, including hours of napping during the day. Mental confusion and extreme lethargy. Inability to read or pay attention to any activity requiring mental work Increasing muscle and joint aching, making sleep surprisingly difficult. Back aches and stiffness particularly. This seems to have decreased in the past 12 hours
65 2021-03-09 nightmare Symptoms began 3/5/21 and resolved by 3/8/21, included headache, fever, sore throat, fatigue, turnin... Read more
Symptoms began 3/5/21 and resolved by 3/8/21, included headache, fever, sore throat, fatigue, turning pale, feeling 'woozy', body aches, sweating, nightmares, ear ache and nerve "jumping" bottom lip. Self treated OTC tylenol, ibuprofen, oral fluids.
65 2021-03-09 sleep disorder Headache. Severe. Level 9 of 10 (10 being worse). Unable to sleep because the headache was so sever ... Read more
Headache. Severe. Level 9 of 10 (10 being worse). Unable to sleep because the headache was so sever I could not lay my head on a pillow.
65 2021-03-13 excessive sleepiness, feeling abnormal Lethargic, for almost two weeks. Slept for the three days straight. Feel and act in a comatose reali... Read more
Lethargic, for almost two weeks. Slept for the three days straight. Feel and act in a comatose reality.
65 2021-03-14 anxiety This person experienced heightened MS symptoms including increased impaired mobility in bilateral lo... Read more
This person experienced heightened MS symptoms including increased impaired mobility in bilateral lower extremities, increased anxiety/stress, and a pounding headache.
65 2021-03-14 sensation of foreign body felt like he had something in his throat, dizzy and wheezing BG was 54 Provided OJ, Benadryl, Epi ... Read more
felt like he had something in his throat, dizzy and wheezing BG was 54 Provided OJ, Benadryl, Epi pen , albuterol and dexamethasone 4mg Symptoms continued called 911 to sent to ED BG improved to 120
65 2021-03-15 nervousness While in Recovery c/o dizziness, feeling flushed, full shaky body tingles. Brought to First Aid area... Read more
While in Recovery c/o dizziness, feeling flushed, full shaky body tingles. Brought to First Aid area. VS taken 152/90, HR 74 Reg, resps 12, SPO2 96%. Left Deltoid site being monitored - LOC - NIV. Water for hydration. Stay for 30 min recheck. Pt stated he feels much better. V-Safe OK'd to exit. S. Reagan RN 3/15/2021 - 3:20pm - Feeling much better.
65 2021-03-17 feeling abnormal Reports shaking episode "like having a seizure but conscious" with spasms in mouth and then unable t... Read more
Reports shaking episode "like having a seizure but conscious" with spasms in mouth and then unable to move legs. Went to sleep and awoke at 3:30 AM feverish and shaking with temperature of 101..0 F. Headache this morning 03/18/21 at 8:41 AM, feels terrible, and shaky on the inside.
65 2021-03-17 insomnia 3 days after second injection of Moderna COVID vaccine my tinnitus increased in volume to a level I ... Read more
3 days after second injection of Moderna COVID vaccine my tinnitus increased in volume to a level I could barely hear and never experienced before. It was difficult to sleep. By morning the ringing had decreased in volume, more like I normally have. I thought it might have been a coincidence, however my wife has now had a similar reaction to J&J vaccine and I have seen others reporting the same issue. My prior reaction to the first and second shots were soreness at the injection site which resolved after 4-5 days.
65 2021-03-20 poor quality sleep Fatigue, slight headache, restless sleep.
65 2021-03-21 loss of personal independence in daily activities Prior to the vaccine on 2/13/21, He was a healthy 65 year old active college professor. 32 hours a... Read more
Prior to the vaccine on 2/13/21, He was a healthy 65 year old active college professor. 32 hours after the vaccination on 2/14/21, He had acute pancreatitis, which led to septic shock and respiratory failure, and he was placed on a ventilator at Hospital. On 2/24/21, he was transferred to Hospital and continued to have additional diagnoses, including polyneuropathy critical illness, acute gangrenous cholecystitis, abdominal pain, anemia, impaired mobility, oropharyngeal dysphagia, pulmonary embolism, and assistance with ADL. On 3/19/21, he was transferred from Hospital to Acute Rehab Unit for acute physical, occupational, and speech therapy. He remains there today. We do not know if this sequence of events is related to the vaccine, but because it occurred one day after the vaccine, we thought it should be reported.
65 2021-03-21 sleep disorder 65 Y male who is referred for c/f dyspnea and chest pain. Per clinic notes: "Brief summary covid va... Read more
65 Y male who is referred for c/f dyspnea and chest pain. Per clinic notes: "Brief summary covid vaccine 1/21 with side effect within 12 hr lasting 3 d By around 1/26-1/29 had cp w/ exertion and sob TST 2/2 w/ Minor ekg changes and min workload per pt (mod workload per note) nuc study pending. Cough and sob worse over the last 5 d or so, sleeping in recliner, and having trouble sleeping. Though no desat on march test, he has freq intermittent coughing and he was tachycardic to 110 on exam this am." Pt states symptoms worsening over past week. No symptoms at rest. With exertion has anterior chest tightness and dyspnea. No radiation of pain or migration. He can walk usual distances but much slower. Improved at rest. Cannot lay flat at night. Cannot sleep much at night. Dry cough. No wt changes or LE pain/swelling. No f/c. No ill contacts. No chest pain currently. Pt underwent exercise treadmill stress test on 2/2/21 that showed borderline ischemic changes (so a myocardial perfusion study was planned) but patient's dyspnea on exertion worsened so he was seen in clinic on 2/10/21 where he was noted to have elevated BNP and D-dimer, was sent to the emergency department where CT angiography was negative for pulmonary embolism but it revealed pulmonary edema with bilateral pleural effusions. Patient was admitted, noted to have elevated troponin, anterolateral ST depressions on EKG, noted to have rapid atrial fibrillation, had NSTEMI so he underwent cardiac cath on 2/10/21 that revealed multivessel coronary artery disease, was hypotensive so IABP was placed, percutaneous coronary intervention of left main, LAD and RCA were done and admitted to the ICU. TTE on 2/11/21 showed LVEF 45% with moderate posteriorly directed MR, was diuresed, started IV amiodarone for SVT and atrial fibrillation, IABP was removed on 2/12/21, dopamine IV drip was weaned and patient was transferred to telemetry on 2/13/21 for further care. Heparin was transitioned to Pradaxa on 2/14/21 and dopamine drip was weaned off on 2/16/21. Patient then had an episode of epistaxis on 2/18/21 (resolved with pressure and Afrin spray), had cough on 2/18/21 and chest x-ray showed mild worsening bilateral central patchy parenchymal opacification so IV Zosyn was started (2/18-2/21/21) then changed to Augmentin (with plans to complete course on 2/24/21), Lasix give for diuresis, CT chest and abdomen was done on 2/20/21 for anemia that showed no obvious hematoma or soft tissue collections. Patient continued diuresis and cardiac medications adjusted. Coronary artery disease, paroxysmal atrial fibrillation, NSTEMI status post percutaneous coronary intervention, cardiogenic shock, systolic dysfunction congestive heart failure, moderate MR: Patient was continued on current cardiac medications including aspirin (for 1 month post cath until 3/10/21), clopidogrel, atorvastatin, Pradaxa, losartan, spironolactone. Continued lasix 80mg PO daily as maintenance diuretic regimen per cardiology recommendations. Patient's current weight is 178 lbs (admission weight was around 189 lbs). Patient was not started on beta blockers given recent cardiogenic shock. Acute kidney injury: Seems to have resolved with current creatinine of 1.2. Leukocytosis: Resolved. Will complete about 7 day course of antibiotics with Augmentin until last dose on 2/23/2021. Tobacco smoker: Patient was counseled on smoking. Patient was advised to quit. Discussed smoking cessation classes. Continued nicotine patch. Anemia: No evidence of active bleeding. Will repeat CBC on 2/26/21 as patient is on dual antiplatelet therapy as well as anticoagulation. Patient was also placed on pantoprazole for GI ulcer prophylaxis. Patient got 2nd COVID19 Moderna vaccine as outpatient on 2/27/21.
65 2021-03-22 mental status changes Patient fell a day prior to receiving the vaccine on 3/18/21. Patient takes Eliquis daily. About on... Read more
Patient fell a day prior to receiving the vaccine on 3/18/21. Patient takes Eliquis daily. About one or two days after receiving the vaccination, the patient's skin became a blotchy red all over. His legs had a "honeycomb" like appearance. His mental status was altered slightly. Patient was admitted to the hospital 3/23/21.
65 2021-03-22 thinking abnormal 12-27-2020 Injection; Volunteered for automated test for nasopharyngeal swab for Covid-19 Antigen on... Read more
12-27-2020 Injection; Volunteered for automated test for nasopharyngeal swab for Covid-19 Antigen on 1-7-2021. No symptoms. Nasal swab had some blood on it because of friable nasal mucosa. The Test (SCV2-SPX-EP molecular test by the lab) was reported positive on 1-10-21. Symptoms then were mild to moderate fatigue, occasional partially productive cough without respiratory distress (SpO2's on room air always > 94%), headache - mild and episodic, dulled sensorium (clouded thinking at times)
65 2021-03-23 agitation, feeling abnormal Agitation / stress, followed later by chronic pain and fatigue, later followed by brain fog and chro... Read more
Agitation / stress, followed later by chronic pain and fatigue, later followed by brain fog and chronic fatigue. Low grade fever at times throughout this sequence. Chronic fatigue remains and seems worse as of 3-24-2021.
65 2021-03-23 anxiety Myalgia, Arthralgia, Fever, anxiety was seen by outside provider for c/o anxiety - received Zofran 4... Read more
Myalgia, Arthralgia, Fever, anxiety was seen by outside provider for c/o anxiety - received Zofran 4mg
65 2021-03-24 feeling abnormal Seen at the walk-In clinic on 3/9/2021 where he presented with complaints of right leg weakness, num... Read more
Seen at the walk-In clinic on 3/9/2021 where he presented with complaints of right leg weakness, numbness, and tingling. He was transferred to ER for further evaluation and management. The symptoms (numbness in his hip and thigh) began around 1400 while he was working. He went about his day. The symptoms progressively worsened while he was ambulating around the hardware store. In the ER, his sensation of his right leg was dulled as compared to the left. The numbness extended from his hip to his toes. Felt a pressure-like sensation in his thigh and calf. Denies pain. Felt as though his right foot is floating 2 inches off the ground when standing with both feet on the ground. Reported his right leg is 1-2 inches shorter after a femur fracture many years ago. Nothing made his symptoms better or worse. Did have an episode of feeling generally hot and then cold the evening prior to admission. Denied any trauma. Denied any dizziness, lightheadedness, headaches, shortness of breath, cough, chest pain, palpitations, vomiting, diarrhea, constipation, blood in stools, urinary habit changes, hematuria, dysuria, pyuria, myalgias, arthralgias, recent illness, or fever. MRI showed T2 changes on the right side of the cord down of the thoracic spine concerning for her transverse myelitis. Patient did have Covid vaccine 7 days prior to onset of symptoms, one dose mRNA vaccine. He is on day 3 high-dose methylprednisolone thousand milligrams IV ×3 days. He has noticed an improvement in the pressure sensation from the knee up the thigh on the right, no longer having tingling in the right lower leg or the left foot. He is still having numbness over the anterior right thigh. Yesterday when he went to bear weight on the right heel, he had a sharp pain with increase in weakness. That has since settled down. He did have a few involuntary myoclonic movements as described yesterday. This writer reached out on 3/22/2021 for information on his Vaccine lot number. He stated "At this point I am attending physical therapy, I am walking with the aid of crutches or a walker. There is improvement in the foot and lower leg regarding the numbness, but the upper thigh is still pretty much completely numb yet."
65 2021-03-24 sleep disorder Sudden onset of shortness of breath, chest tightness and coughing. His usual rescue inhaler didn't... Read more
Sudden onset of shortness of breath, chest tightness and coughing. His usual rescue inhaler didn't help symptoms. Up all night long. Unable to lay down as it made his breathing worse. The next day, he did a nebulizer treatment and that helped his symptoms. Unfortunately, he has had an acute asthma attacks nearly every day since. Starting 1 week ago, symptoms have gradually improved. He is still having to use his nebulizer, but not as often, as his usual inhalers have not been ineffective.
65 2021-03-25 impaired work ability, excessive sleepiness Woke up for work at 3:45 am . Just didn't feel good. Went back to bed and then went down hill. Felt ... Read more
Woke up for work at 3:45 am . Just didn't feel good. Went back to bed and then went down hill. Felt like I got hit by a freight train and a sever headache. Could not open my eyes it hurt so bad. Tried to sleep for the next 12 hours. Headache had let up some body felt sore. Was up for about 2 hours and went back to bed till the next morning. Felt much better but was wore out from the day before. By the 2nd day evening felt back to normal.
65 2021-03-25 poor quality sleep 1st shot, sore at injection site, no problem. 2nd shot, felt feverish that evening. Sore at injecti... Read more
1st shot, sore at injection site, no problem. 2nd shot, felt feverish that evening. Sore at injection site. Toss and turn all night. 100.8* fever, aches, pains, chills. No other symptoms yet the morning after 2nd shot.
65 2021-03-26 impaired work ability 12 hrs after shot around midnight, Dizzy when eyes open, Body ache , Joint pain , Fatigue, Chill... Read more
12 hrs after shot around midnight, Dizzy when eyes open, Body ache , Joint pain , Fatigue, Chills, Sinus pressure , Slight Headache and Thirsty, 5 glasses of water in 5 hours, lasted 24 hours. Off work on Thursday 3-25-21. Friday 3-26-21 at 1am symtoms gone except for back pain. Saturday 3-27-21 1am Night sweats x 3 till 5am. Went to work Saturday
65 2021-03-28 disturbance in attention, sleep disorder 07:00 - Lethargy, mild muscle pain, mild headache - could not sleep in bed or chair. Concentration ... Read more
07:00 - Lethargy, mild muscle pain, mild headache - could not sleep in bed or chair. Concentration was poor - so wandered around the house slowly. (1 tablet of Naproxen Sodium 220 mg) 11:00 - Chills/Shakes, very tired could not wander, heavy fleece garments in chair with heating pad for back muscles, and fleece blanket. Continuous chills/shakes, drifted in and out of sleep but often woken by chills/shakes. 14:00 woke to use restroom - chills/shakes ongoing. Filling out this form while shaking. Muscle aches continue. (1 table of Acetaminophen 250/asprin 250/caffeine 65
65 2021-03-29 disorientation Patient was fully vaccinated (dose 1: 1/19 dose 2: 2/16). Patient developed fatigue on 3/1 then test... Read more
Patient was fully vaccinated (dose 1: 1/19 dose 2: 2/16). Patient developed fatigue on 3/1 then tested positive for COVID the following day (3/2). Was self-isolating at home and did not receive any COVID therapies. He reports progressively worsening fatigue, productive cough (white sputum), loss of taste, disorientation, and poor PO intake. Patient arrived to the ED for COVID-19 symptoms (3/13), tested positive and was admitted for severe hypoxic respiratory failure due to COVID-19. Patient with AKI (creatinine =2.48) Patient escalated to HFNC then down to 6L NC to 4L then slowly weaned to RA. Received dexamethasone 6 mg daily x 10 days. Patient was admitted from 3/13 to 3/18 for COVID-19. Creatinine on discharge was 1.29
65 2021-04-04 feeling abnormal Vaccine received on Thursday at 3:08 pm. Headache, nausea, temperature (Tmax 101.7), extreme muscl... Read more
Vaccine received on Thursday at 3:08 pm. Headache, nausea, temperature (Tmax 101.7), extreme muscle pain and joint discomfort all day Friday. 2 Tylenol Extra strength taken at 10 pm on Friday evening and repeated at 10 am on Saturday morning (I don't like to take medicine and held off as long as I could). Temperature on Saturday in the 100.3 to 100.7 range down to the 99.1 - 99.5 range on Sunday. Intermittent muscle and joint pain that subsided by Sunday morning. Remain with occasional slight headaches and not feeling "normal"
65 2021-04-07 confusional state, feeling abnormal Fatigue, mental confusion, brain fog. Moderate skin rash lasting 5 days
65 2021-04-07 sleep disorder I woke up at night and my heart was racing. I woke up from a dead sleep, I was not short of breath a... Read more
I woke up at night and my heart was racing. I woke up from a dead sleep, I was not short of breath and no chest pain. I just feel my heart racing. I was observed for a 4 hours and discharged the next morning.. My blood Pressure was 158/96. I had had Covid-19 tested positive on 12/29/2021. I had the second dose, and I did not experience the same symptoms.
65 2021-04-08 feeling abnormal 1st dose - local soreness at injection site several days, very mild brain fog afternoon after mornin... Read more
1st dose - local soreness at injection site several days, very mild brain fog afternoon after morning injection 2/27/21 10AM 2nd dose (this report, received 10AM 4/6/21) - local soreness at injection site several days, morning after 2nd injection woke with severe headache and muscle/join aches (particularly hips) , moderate fever (100 Fahrenheit), moderate brain fog. Symptoms moderated with aspirin (I prefer no to use acetaminophen) , symptoms persisted throughout the day, retired that evening early with symptoms. 2nd morning after 2nd injection awoke with mild body/join aches, no headache or brain fog, mild fever (99 Fahrenheit, my normal temperature is 97.9 Fahrenheit). Again moderated with aspirin. 3rd day after 2nd injection - normal temp, very mild almost unnoticeable muscle/joint aches, no headache or brain fog.
65 2021-04-09 feeling abnormal slipped in ice twice, and after second time, he went to the hospital and underwent surgery; slipped ... Read more
slipped in ice twice, and after second time, he went to the hospital and underwent surgery; slipped in ice twice, and after second time, he went to the hospital and underwent surgery; difficulty walking/drags the leg while walking; feeling so debilitated; cramps all over the body; body aches; could not get up of the bed not even to get to the restroom, he could not get up straight; had no strength; pain in his back, his lower back; difficult to get up; legs very, very cold, freezing cold; with a walking stick; no strength in legs and hands; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (slipped in ice twice, and after second time, he went to the hospital and underwent surgery) and ACCIDENT (slipped in ice twice, and after second time, he went to the hospital and underwent surgery) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced MUSCULAR WEAKNESS (no strength in legs and hands) and WALKING AID USER (with a walking stick). On 17-Mar-2021, the patient experienced DYSSTASIA (difficult to get up) and PERIPHERAL COLDNESS (legs very, very cold, freezing cold). On 18-Mar-2021, the patient experienced MOVEMENT DISORDER (could not get up of the bed not even to get to the restroom, he could not get up straight), ASTHENIA (had no strength) and BACK PAIN (pain in his back, his lower back). On 19-Mar-2021, the patient experienced FALL (slipped in ice twice, and after second time, he went to the hospital and underwent surgery) (seriousness criterion hospitalization) and ACCIDENT (slipped in ice twice, and after second time, he went to the hospital and underwent surgery) (seriousness criterion hospitalization). On 28-Mar-2021, the patient experienced FEELING ABNORMAL (feeling so debilitated), MUSCLE SPASMS (cramps all over the body) and MYALGIA (body aches). On an unknown date, the patient experienced GAIT DISTURBANCE (difficulty walking/drags the leg while walking). The patient was hospitalized from 19-Mar-2021 to 28-Mar-2021 due to ACCIDENT and FALL. At the time of the report, FALL (slipped in ice twice, and after second time, he went to the hospital and underwent surgery), ACCIDENT (slipped in ice twice, and after second time, he went to the hospital and underwent surgery), MUSCULAR WEAKNESS (no strength in legs and hands), GAIT DISTURBANCE (difficulty walking/drags the leg while walking), WALKING AID USER (with a walking stick), DYSSTASIA (difficult to get up), PERIPHERAL COLDNESS (legs very, very cold, freezing cold), MOVEMENT DISORDER (could not get up of the bed not even to get to the restroom, he could not get up straight), ASTHENIA (had no strength), BACK PAIN (pain in his back, his lower back), FEELING ABNORMAL (feeling so debilitated), MUSCLE SPASMS (cramps all over the body) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. There were no concomitant medications reported. No treatment information provided. Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities.; Sender's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities.
65 2021-04-11 hallucination Started Hallucinating, couldn't grab or hold anything. Hard time walking or standing. All started on... Read more
Started Hallucinating, couldn't grab or hold anything. Hard time walking or standing. All started on the evening of April 9. Shot was given April 9,at 8:38 am. Symptoms stopped Sunday April 11 around 4:00 pm.
65 2021-04-12 sleep disorder Tinnitus- Current and continuous during all day beginning 2 days following 2nd injection. Causes sl... Read more
Tinnitus- Current and continuous during all day beginning 2 days following 2nd injection. Causes sleep disruption. Experienced almost daily, but not all day tinnitus beginning a few days after 1st injection.
65 2021-04-13 feeling abnormal week after second dose patient skin became pink, eyes swelled almost shut, feeling of picky feeling ... Read more
week after second dose patient skin became pink, eyes swelled almost shut, feeling of picky feeling inside Patient currently taking Xyzal
65 2021-04-14 feeling abnormal Patient presented to our facility due to progressive swelling of his LLE. Patient is an avid cyclist... Read more
Patient presented to our facility due to progressive swelling of his LLE. Patient is an avid cyclist and reports he began training again for the spring season approx. 1 mo ago. He had L calf tightness present for a few weeks as well as slightly painful knees which he attributed to his age and mild deconditioning over the winter. He traveled with infrequent stops on 4/2/2021 to visit family. He continued to have discomfort and increasing ankle pain, thus presented to ER. LE ultrasound venous dopplers performed showing extensive DVT: L femoral, popliteal, posterior tibial and peroneal veins. CT also demonstrated acute PE w/in distal R and L main pulm artery and w/in bilateral segmental and subsegmental pulm arteries involving all the lobes. Patient had remote history of LE DVT in 2017 after mild bumping of leg and placed on Xarelto for 6 mo. Had genetic testing completed at that time which was negative. He has had no clotting issues since. ( Received Moderna COVID-19 vaccines on 2/3/21 and 3/3/21. Reports brain fog and fatigue approx. 20 hours after vaccination followed by the above.) Patient discharged on rivaroxaban.
65 2021-04-15 loss of personal independence in daily activities, sleep disorder Stomach pain and cramps. Frequent loose bowel movements, 15-20 per day. Excessive gas (burping) an... Read more
Stomach pain and cramps. Frequent loose bowel movements, 15-20 per day. Excessive gas (burping) and farting constantly. Fatigue and weak. Lack of sleep due to having to go to rest room frequently. Hemorrhoids pain and some bleeding due to frequent bowel movements. Functioning daily activities difficult due to having lack of sleep and frequent rest room visits. Symptoms still going-on as of 16 April 2021.
65 2021-04-19 sleep disorder Chills, Nausea, Entire Body Aches, Fever, No Appetite, No Sleep, Headache for36 hours, starting 15 ... Read more
Chills, Nausea, Entire Body Aches, Fever, No Appetite, No Sleep, Headache for36 hours, starting 15 Hours after 2nd vaccine, Home location throughout. Urine discoloration.
65 2021-04-20 confusional state pt reports a very itchy rash on arms and thighs that appeared about 1 hour after vaccination and con... Read more
pt reports a very itchy rash on arms and thighs that appeared about 1 hour after vaccination and continued for 4 days. the pt reports that he did not apply any creams or take any medications for the reaction. the patient also reports feeling "mixed up."
65 2021-04-21 sensation of foreign body LUMP IN THROAT Narrative: Presented back to vaccine clinic at 0930 reporting that she felt like s... Read more
LUMP IN THROAT Narrative: Presented back to vaccine clinic at 0930 reporting that she felt like she had a lump in her throat. No diff swallowing, no shortness of breath, and declined urticaria/itching. She received her first dose of Moderna at 0916. B/P 173/103 HR 88 no evidence of any respiratory distress,stridor, wheezing, dyspnea, increased work of breathing, retractions, persistent cough, cyanosis, signs of poor perfusion, abdominal pain, vomiting, dysrhythmia, hypotension upon exam. Veteran is able to speak clearly. Respirations evan and nonlaboared with clear breath sounds throughout 1015 reports that the lump in her throat has resolved. She declines any shortness of breath/diff breathing, respiratory distress, urticaria/pruritus and is able to speak in clearly without difficulty.
65 2021-04-22 loss of personal independence in daily activities Whole-body muscle fatigue. Joint pain: toes, ankles, knees, shoulders, elbows, wrists, hands and fin... Read more
Whole-body muscle fatigue. Joint pain: toes, ankles, knees, shoulders, elbows, wrists, hands and fingers. Multiple blood tests with negative results. MRI spine and EMG arms and hands. Diagnosis: carpal tunnel both wrists. All previously listed joints remain inflamed and painful. Conditions did not exist before second COVID shot. Rheumatologist appointment scheduled for May 14. Hands are numb and affecting daily activities. Have seen primary doctor twice and neurologist twice.
65 2021-04-24 loss of personal independence in daily activities Shortness of breathe with reduced pulse Ox of 93, trouble breathing, body aches, arm soreness, chill... Read more
Shortness of breathe with reduced pulse Ox of 93, trouble breathing, body aches, arm soreness, chills, fever, headache, excessive burping, weakness, unable to care for self
65 2021-04-26 disorientation, feeling abnormal On 04/20/21 at approx. 1:30 AM he awoke disoriented, lightheaded, "feeling funny" - knew something w... Read more
On 04/20/21 at approx. 1:30 AM he awoke disoriented, lightheaded, "feeling funny" - knew something was different. States he could not make works come out his mouth, make complete sentences. This lasted for 7 or 8 minutes, then cleared up. He called his PMD that morning and was told to go to ER. He went to Hosp. ER, but was then sent to another Hospital. Hospitalized from 04/20/21 and discharged late afternoon of 04/22/21. Extensive blood work done, CAT scan, MRI, Carotoid ultrasound, Echo cardiogram. No signs of A-fib, cholesteral slightly elevated. DX. with TIA. Referred back to his cardiologist Has been under care of his cardiologist for 7 plus years - Pt is an active runner - Runs approx. 6 days a week for 2 1/2 to 3 miles per day. For the past few months he has switched to interval walk/run. After 1st dose of Moderna 03/03/21 - Reports no issues expect slight injection site discomfort. After his second dose of Moderna 03/31/21 - Reports chills 12 hours after injection, low-grade fever (99.0 - 100.0) started 14 hours after the injection. All symptoms resolved 30 hours after injection date and time. Stated he kept notes of this.
65 2021-04-26 sleep disorder Pt received dose #1 of Moderna on 1/20/2021 at clinic. On 1/24/2021, developed self reported fatigue... Read more
Pt received dose #1 of Moderna on 1/20/2021 at clinic. On 1/24/2021, developed self reported fatigue and sleep disturbances with pruritis. Sought no medical care. Routine labs were obtained on 2/23 which demonstrated new-onset transaminitis and hyperferritinemia (ALT 2366, AST 1260, alk phos 362, ferritin 32,000) and was admitted to hospital for evaluation. No etiology for acute liver failure identified, including comprehensive evaluation for viral hepatitis and other common causes of hepatitis common after transplant. Concern raised for hemophagocytic lymphohistiocytosis (HLH) due to extreme hyperferritinemia, although bone marrow biopsy negative. Ultimately transferred to another hospital for further care at patient's request. No specific treatment was given and transaminitis ultimately resolved. Soluble IL-2 receptor (CD25) level checked on 3/2, at time of admission, markedly elevated at 2338.6, consistent with diagnosis of HLH. Pt discharged on 3/5. Ultimately readmitted on 3/9 and found to have rapidly progressive Legionella pneumonia and died on 3/16. Two events felt to be unrelated and pneumonia not felt to be cause of HLH due to patient's status at time of initial admission.
65 2021-04-29 loss of personal independence in daily activities 65-year old man with PMH notable for CAD s/p 3v CABG 2015, HFrEF (EF 54% 11/2020), CKD, T2DM (A1c 7.... Read more
65-year old man with PMH notable for CAD s/p 3v CABG 2015, HFrEF (EF 54% 11/2020), CKD, T2DM (A1c 7.5% 9/2020), and OSA, presenting with 2 days of weakness, malaise, difficulties getting out of bed and walking. The patient was in his normal state of health until he got the 2nd dose of the moderna covid vaccine two days ago; since then he has been somnolent, weak, not eating or drink much, and slid out of his bed and woke up on the floor once. He came to the ED because he was so weak that he couldn't walk. He furthermore endorses suprapubic and generalized right-sided abdominal tenderness that started after two episodes of nonbloody emesis and chills while waiting in the ED. He denies fevers, chest pain, dyspnea, orthopnea, lower extremity swelling, palpitations, brbpr, melena, dysuria, rash, easy brusing/bleeeing, headache, vision changes, and sensory changes.
65 2021-05-05 emotional distress Date and time adverse event started: 1st dose symptoms occurred approx 1/31/2021 (3-4 days pos-vac).... Read more
Date and time adverse event started: 1st dose symptoms occurred approx 1/31/2021 (3-4 days pos-vac). 2nd dose symptoms occurred right away. Date and time of vaccination: (list both if they received both shots): 1st dose 1/29/2021 ~1300-1400. 2nd dose 2/26/2021 ~1300-1400. Pt reported ~3-4 days post-vac of 1st dose, pt experience ache and pain in every joints "joints felt like I was crippled", reports his whole body was in agony only with movement but not at rest. Pt reported that these symptoms did not subsided and the 2nd shot seems to make the symptoms worse per had lots of muscle pain and he could not move, had to have his wife help him in and out of the bed. Pt reported he took extra strength Tylenol on 2/27/2021 after his 2nd shot for a duration of 3-4 days which provided no relief. Pt reported that just approx. a little over a week prior to his scheduled orthopedic surgery (2/18/2021 - for an microscopic surgery for his torn MCL in his left knee), pt was seen by his orthopedic surgeon because his left knee had puffed up on the side, as a result his doctor drained his left knee and gave the pt a cortisone injeciton in his left knee to reduce inflammation. Pt reports that after rcvding cortisone injection he felt great and all his ADEs from the Moderna vaccine subsided. Pt reported that his orthopedic surgeon had adv that his ADEs of joint and muscle pain and achiness may be vaccine related. Pt reported doctor prescribed him Methylprednisolone 6 days dosing regimen approx. 1 month ago, and while taking pt reported he felt great and all symptoms subsided. Then approx 3-4 days post last Methylprednisolone dose was taken pt reports all his symptoms came back again. Pt reached out to his orthopedic surgeon again and got another prescription for Methylprednisolone and just completed his last day of dosing today and reported no pain again while on the treatment. Pt have another follow up appointment with orthopedic surgeon on 5/4/2021. Recommend pt to monitor if any of those symptoms occur again, and if so discuss with doctor and contact MD for further evaluation. 5/5-Patient does not have any pain at this time, he went to see orthopedic surgeon yesterday on 5/4/21 to get another Methylprednisone script just in case of relapse since the steroids significantly helped with pain in left knee. Ortho surgeon did not refill Methylprednisone script. Patient is upset and is at primary provider's office today to get another script.
65 2021-05-05 feeling abnormal Dizziness, vertigo, light-headed, brain fog, equilibrium (falling), increased tinnitus
65 2021-05-11 insomnia Difficulty sleeping and fatigue for 1 1/2 months
65 2021-05-20 mental status changes Pt presented to our facility on 5/11/21 with altered mental status and tachypnea, ultimately diagnos... Read more
Pt presented to our facility on 5/11/21 with altered mental status and tachypnea, ultimately diagnosed with Bickerstaff Brainstem Encephalitis (Guillain-Barre variant) by neurology. Currently intubated and receiving IVIG.
65 2021-05-24 confusional state, feeling abnormal Wife reporting this information, her husband is in prison. He informed her that he did not have a c... Read more
Wife reporting this information, her husband is in prison. He informed her that he did not have a choice to take the vaccines. He does have a heart condition. He feels that he was coerced to get the vaccine, and informed that if he did not take it that he would be moved to an area where he would not have privileges for visitors, etc., and then found out a week later that was not the truth. He got his vaccine, he has more shortness of breath, bad pain in his joints, lots of confusion with his brain, blood blisters on his hands that are oozing on his fingers. Sick for 2 days on the 2nd vaccine, but he continues with joint pain, oozing, and brain fog. He has an injury to his knee and he cannot get to the infirmary and cannot buy Tylenol in the canteen.
65 2021-05-27 thinking abnormal Had problems with throat getting stuck/Heimlich to get food out; Sweating; Would drink water and hav... Read more
Had problems with throat getting stuck/Heimlich to get food out; Sweating; Would drink water and have problems getting it down throat/Heimlich to get food out; Had problems breathing; can't think straight; Fever; Chills; Muscle soreness in back/Muscle soreness in legs; Muscle soreness in ankle; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Had problems with throat getting stuck/Heimlich to get food out) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cancer. On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), DYSPHAGIA (Would drink water and have problems getting it down throat/Heimlich to get food out), DYSPNOEA (Had problems breathing), THINKING ABNORMAL (can't think straight), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle soreness in back/Muscle soreness in legs) and ARTHRALGIA (Muscle soreness in ankle). On an unknown date, the patient experienced CHOKING (Had problems with throat getting stuck/Heimlich to get food out) (seriousness criterion medically significant). At the time of the report, CHOKING (Had problems with throat getting stuck/Heimlich to get food out), HYPERHIDROSIS (Sweating), DYSPHAGIA (Would drink water and have problems getting it down throat/Heimlich to get food out), DYSPNOEA (Had problems breathing), THINKING ABNORMAL (can't think straight), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle soreness in back/Muscle soreness in legs) and ARTHRALGIA (Muscle soreness in ankle) outcome was unknown. Concominant medications included unknown cancer medications. On an unknown date, treatment included the Heimlich maneuver. 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. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
65 2021-06-06 disturbance in attention, impaired work ability, memory impairment This is a Physician reporter who is willing to provide further information if needed. The day of th... Read more
This is a Physician reporter who is willing to provide further information if needed. The day of the vaccine I started to have tightness like a Broncho Spasm in my chest 30 minutes after the vaccine.. My co-workers told me I was flushed. I was a little short of breath and my pulse was elevated. It seemed to improve after a little time. I started to feel worse on 01/12/2021. Ten days after the vaccine I tested positive on 01/14/2021for Covid-19. I had serious symptoms with the Covid-19. After five months I have been unable to work as a Physician and I am still having. I recently got tested for Polyethylene Glycol and I tested positive on a skin test. I am unsure whether to get the second dose. I also have headaches and memory defects muscle aches weakness and a weak left arm. My headaches happen daily and they vary in severity. I am scheduled to have a Bifrontal MRI tomorrow. I started to have problems with concentration within a week of the vaccine and I am still having problems with that. I experience muscle and body aches as well as neck and shoulder problems. My energy level is improved but still very low. I am scheduled to see a Neurologist. My left arm is very weak from the shoulder to the forearm since that time Radiculopathy.
65 2021-06-06 nervousness, impaired work ability Woke up the 2nd morning and tried to stand up, I immediately fell back onto bed and the room was unc... Read more
Woke up the 2nd morning and tried to stand up, I immediately fell back onto bed and the room was uncontrollably spinning very badly. Tried to call out but was unable to due to the dizziness. after about 10 min the dizziness subside enough to call out and get help. was unable to lift my head off bed without uncontrollable dizziness. stayed in bed the entire day with 1 trip to bathroom. The trip to the bathroom I basically crawled since I was unable to stand up. The dizziness lasted for about 5 week. Unable to look up due to dizziness coming back. I lost 7 days of work and was extremely cautious of falling over going to work. Loss of appetite, balance, and a feeling of nervousness lasted for many weeks. Visited by family doctor and said it was nothing and not related to corvid injection. Visited neurologist and said it was not related to corvid injection. N one seemed to know what the problem was except I know it was caused by the injection.
65 2021-06-10 confusional state Slurred speech, loss of use of limbs, confusion, heart inflammation and liver failure
65 2021-06-15 impaired work ability 1st Moderna vaccine 3/18/21, no symptoms/adverse events. 2nd moderna vaccine 4/14/21, no adverse eve... Read more
1st Moderna vaccine 3/18/21, no symptoms/adverse events. 2nd moderna vaccine 4/14/21, no adverse events until 5/28/21 had lost ability to move left side, was found on floor in home 4 days later on 5/26. Taken to hospital and was diagnosed with stroke. I asked the physician to report this to VAERS and he wouldn't because he didn't believe the vaccine was the cause. CDC states healthcare providers are required by law to report any unplanned hospitalization, disability (no date limit) after covid-19 vaccination, but physician kept refusing to report this to VAERS. My husband was from home independently and is now disabled, unable to move his left side and is going to a facility for long term care.
65 2021-06-17 sensation of foreign body 2-3 days of swelling of throat/neck with a sensation of a foreign body in throat then lost voice ... Read more
2-3 days of swelling of throat/neck with a sensation of a foreign body in throat then lost voice or raspy voice for weeks.
65 2021-06-18 feeling abnormal heavy legs; Stroke; runny nose; a little temp; Not feeling himself; headache; This spontaneous case ... Read more
heavy legs; Stroke; runny nose; a little temp; Not feeling himself; headache; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and LIMB DISCOMFORT (heavy legs) in a 65-year-old male 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 Atrial fibrillation since 2017. On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 28-Jan-2021, the patient experienced LIMB DISCOMFORT (heavy legs) (seriousness criterion hospitalization) and FEELING ABNORMAL (Not feeling himself). On an unknown date, the patient experienced RHINORRHOEA (runny nose) and BODY TEMPERATURE ABNORMAL (a little temp). The patient was hospitalized from 29-Jan-2021 to 02-Feb-2021 due to CEREBROVASCULAR ACCIDENT and LIMB DISCOMFORT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident and Rehabilitation therapy for Limb discomfort. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), LIMB DISCOMFORT (heavy legs), RHINORRHOEA (runny nose), BODY TEMPERATURE ABNORMAL (a little temp) and FEELING ABNORMAL (Not feeling himself) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included blood thinners which patient had reportedly been taking for approximately four years to treat atrial fibrillation. Treatment included rehabilitation and learning how to ambulate with a walker. Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities. This case was linked to MOD-2021-008992 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Case updated to serious, events added.; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities.
65 2021-06-24 hallucination Pt reported was diagnosed by ER and PCP that he had allergic reaction to Moderna. Pt reports was hal... Read more
Pt reported was diagnosed by ER and PCP that he had allergic reaction to Moderna. Pt reports was hallucinating and passed out in shower twice causing 2 ER visits. Previous VEARS report uncertain and felt information collected needed reporting
65 2021-07-16 amnesia Global Transient Amnesia - sudden onset of memory loss and inability to form short term memory. No ... Read more
Global Transient Amnesia - sudden onset of memory loss and inability to form short term memory. No other medical problems. Lasted about six hours
65 2021-07-18 excessive sleepiness The first two weeks after the vaccine I got severe muscle spasms that were pretty much all over my b... Read more
The first two weeks after the vaccine I got severe muscle spasms that were pretty much all over my body but they were mostly in my back, I could not even stand up straight. I was 50/60 degrees, could not stand up straight. Also for like 3 days straight I just slept. The back spasms were the worst, they have gradually gotten better but not completely better. It progressively gets better, but is going very slow. I talked to my DR and my Rheumatologist several times throughout this time and I saw my DR at least once every six weeks since this began and Rheumatologist once since this has happened. This started on 2/19/2021 and it is now 7/19/2021. My Internist put me on Prednisone and Valium and muscle relaxer. The Prednisone helped, I was given those medications at different times, about a month apart.
65 2021-07-18 loss of personal independence in daily activities The evening of shot started having pain that didn't go away and it became very bad in joints and mus... Read more
The evening of shot started having pain that didn't go away and it became very bad in joints and muscles of upper arm which went down to his elbows on his left arm. Have hard time putting on shirts because of the pains
65 2021-07-24 sleep disorder, impaired work ability, anxiety Patient complains of fatigue since the completion of the Moderna series. He has experienced a 5 poun... Read more
Patient complains of fatigue since the completion of the Moderna series. He has experienced a 5 pound weight gain. Pt has felt tired and fatigue that prevents him from working. Some days he experiences extreme fatigue and has difficulty speaking without getting shortness of breath. He has also developed anxiety and has difficulty falling asleep and wakes up throughout the night.
65 2021-07-25 feeling abnormal extreme nausea, heart palpitations, sweating (first night). Weekly bouts of nausea, reduced appetit... Read more
extreme nausea, heart palpitations, sweating (first night). Weekly bouts of nausea, reduced appetite, weight loss, difficulty waking up, brain fog.
66 2020-12-31 disorientation Patient reports "disorientation". He states that "it might not be the vaccine though because my doc... Read more
Patient reports "disorientation". He states that "it might not be the vaccine though because my doctor is adjusting my Levothyroxine dosage right now". It lasted a couple of days. Symptoms improved at the time of the completion of this report.
66 2021-01-02 anxiety TINGLING IN EXTREMITIES AND TONGUE, TONGUE SWELLING, MILD HTN, TREATED FOR ALLERGIC RXN WITH DIPHENH... Read more
TINGLING IN EXTREMITIES AND TONGUE, TONGUE SWELLING, MILD HTN, TREATED FOR ALLERGIC RXN WITH DIPHENHYDRAMINE 25MG IM INJECTION AND MONITORED FOR SIGNS OF ADDITIONAL ALLERGIC RXN/ANAPHYLAXIS. S/S RESOLVED S/ DIPHENHYDRAMINE AND TIME. PT WAS ALSO MILDLY HYPOCAPNIC ON ETCO2 MONITORING AND STATED THAT S/S COULD BE DUE TO MILD ANXIETY.
66 2021-01-07 sleep disorder Pt received 1st dose of Moderna COVID-19 vaccine on 01/04/2021 in L deltoid. Came back to clinic at ... Read more
Pt received 1st dose of Moderna COVID-19 vaccine on 01/04/2021 in L deltoid. Came back to clinic at 0800 on 01/06/2021 c/o excruciating pain in entire L arm radiating to neck, chest, and around his upper and lower back. States it started the evening of 01/04/2021 and progressively has gotten worse. States it woke him up at 0130 on 01/06/2021 and that he hadn't been able to get back to sleep because of the pain. Rated pain 9.5/10. No redness or s/s of infection at injection site. Some swelling present at the site. L forearm and hand were slightly erythematous, and he was unable to move arm or fingers much. RN had to assist with putting his jacket back on. States has tried ice packs, tylenol, ibuprofen, tramadol, gabapentin, and oxycodone with no relief. BP 143/93, P 77, RR 22, O2 sat 96%. Advised to call PCP and either wait until urgent care in town opens at 1100, or if he can safely drive to another city, go to urgent care there because they open at 0800. Advised if unable to drive to other city and can't wait until 1100, to go to the ER. On 01/07/2021, called pt in the evening to follow up. Pt stated he did go to the ER in town right after coming to the clinic, where they performed an ultrasound of his arm to check for retained fluid, but his results were normal. Pt states ER advised him to try hot packs on his arm and to return if he still found no relief. Pt states the hot packs did help some, but was still experiencing pain 6/10, but that the intensity of it had worn off a little and that it was becoming more manageable
66 2021-01-08 confusional state, disorientation Confusion disorientation; pain at injection site Narrative:
66 2021-01-09 insomnia Chills, fever, pain in shoulders, soreness in legs, unable to sleep
66 2021-01-13 emotional distress Systemic: Non-specific reaction occurred appoximately 1 hour post-vaccination. Pt unable to provide ... Read more
Systemic: Non-specific reaction occurred appoximately 1 hour post-vaccination. Pt unable to provide clear answers when questioned and appeared to be in distress. BP was 100/78, HR in mid-70s, and blood glucose; symptoms lasted 0 days
66 2021-01-13 excessive sleepiness On Jan 11, 21 immediately after the vaccine I felt my heart wad high. Then after an hour I felt dizz... Read more
On Jan 11, 21 immediately after the vaccine I felt my heart wad high. Then after an hour I felt dizzy for couple hours. At night on the same day, I had chills, temperature 101 F. Had Tylenol. Next day on January 12, 21 felt feverish, body pain, tired and lost some food taste. So slept all day. Same later in the evening started coughing. January 13 and 14, 21 felt tired and dizzy when I stand up. Had cough syrup and today it has improved. However, still feel dizzy but hope to recover gradually. Daughter is listed as my doctor. She is my daughter. She watches me but she is not my official physician.
66 2021-01-20 memory impairment, disorientation severe cognitive impairment, at first disorientation followed closely by general cognitive disabilit... Read more
severe cognitive impairment, at first disorientation followed closely by general cognitive disability with 70% loss of short term memory. lasted and worsened over 4 days, Started Prednisone and cleared within 6 hrs by 70% took additional prednisone following day as some regression and cleared in hrs to 98% and holding
66 2021-01-21 insomnia Sleeplessness, up and down all night Thursday to Friday Severe Headache Fever Chills Achiness When ... Read more
Sleeplessness, up and down all night Thursday to Friday Severe Headache Fever Chills Achiness When he gets sick he says his skin hurts
66 2021-01-23 feeling abnormal 5:30 am. -Mind "cloudy", tightness in lower esophageal area, minor swallowing difficulty, fatigue. 9... Read more
5:30 am. -Mind "cloudy", tightness in lower esophageal area, minor swallowing difficulty, fatigue. 9:00 am. - progression of previous symptoms with addition of discomfort on chest area, severe acid reflux. 1:00 pm. - further progression of previous symptoms with addition of pain in neck and jaw area and headache, occasional feeling of shortness of breath. 7:00 pm - all symptoms began to progressively decrease in mostly the same order of onset. 11:00 pm - Continued decrease in symptom severity. 1/24 @ 8:00 am - Symptoms subsided with exception of minor degree of swallowing difficulty and reflux.
66 2021-01-23 impaired work ability On Dec 25 developed fever, chills, headache and general fatigue with no desire to engage in normal f... Read more
On Dec 25 developed fever, chills, headache and general fatigue with no desire to engage in normal family activities. Dec 26,27,28 were spent in bed with a low energy level and headache mimicking severe sinus pain. No fever after Dec 26. Headache and general fatigue lessened gradually after Dec 28. I would not have been able to perform my normal occupation the week of Dec 27 to Jan 2. Full recovery the week of Jan 3.
66 2021-01-28 mental status changes Extreme bouts of nausea first few days after vaccine. Estimated that patient died at home within 3... Read more
Extreme bouts of nausea first few days after vaccine. Estimated that patient died at home within 3-4 days after receiving the vaccine. Last phone call to daughter expressed extreme nausea and seemed to have altered mental status. Found dead by daughter on 01/04/2021.
66 2021-01-29 feeling abnormal very sore arm for 3 days, a bit dizzy 2 hrs after shot, lasted about 5 mins, foggy brain for a few ... Read more
very sore arm for 3 days, a bit dizzy 2 hrs after shot, lasted about 5 mins, foggy brain for a few days
66 2021-01-31 feeling abnormal Around 8:30PM started to feel bloated and the feeling of something out of the norm. Around 8:45PM-d... Read more
Around 8:30PM started to feel bloated and the feeling of something out of the norm. Around 8:45PM-diarrhea. Then, nausea followed quickly. Stood up, felt light-headed, and vomited several times. Went to bed around 9:30PM. Got up 3 times during the night with diarrhea. Got up in the morning and felt fine. No headache or fever. But was feeling chilled when I went to bed.
66 2021-02-01 insomnia Sore shoulder, headache, sleeplessness, fever
66 2021-02-03 poor quality sleep Patient called in today, 02/04/2021 to let me know he had some adverse reactions to the COVID vaccin... Read more
Patient called in today, 02/04/2021 to let me know he had some adverse reactions to the COVID vaccination he received on 02/02/2021. Patients states that in the evening after the vaccination he developed at 102 degree f. fever that was accompanied by a headache and body aches. Patient also stated he did not sleep well that night. He stated his this symptoms lasted approximately 24 hours. He denied any symptoms today. Patient also reported that he was positive for Covid-19 in March of 2020.
66 2021-02-05 feeling abnormal, insomnia 8 hours after injection started with extreme fatigue, chills , sore arm. Over next 7 days experience... Read more
8 hours after injection started with extreme fatigue, chills , sore arm. Over next 7 days experienced severe symptoms : fatigue, myalgias, chills, arm pain, nausea, vomiting , abdominal pain, mental fog, insomnia, anorexia, change smell.
66 2021-02-12 emotional distress, confusional state, disorientation syncope, c/o itchy throat Narrative: Patient was seen prior to administration of the Moderna COVID-1... Read more
syncope, c/o itchy throat Narrative: Patient was seen prior to administration of the Moderna COVID-19 vaccination. He has allergies to bees/egg and a h/o anaphylaxis 2/2 receiving an injection of penicillin in the past. Discussed that prior h/o anaphylaxis to PCN injection was not a contraindication to this vaccination, but is a precaution. Discussed risks of receiving the vaccination vs benefits of the vaccine, which patient states "I already had this discussion with Dr.!" He has multiple comorbidities which place him at a higher risk for more severe illness from COVID-19. Again received the risk vs benefit discussion. Patient stated understanding and desire to proceed with the vaccination. He will be monitored for at least 30 minutes in area where staff can directly observe him. Patient received the COVID vaccination at 13:00. At 45 minutes later, staff alerted that he was c/o palpitations. Due to confusion and weakness, we were unable to transport him to an examination room. Oxygen, water, and vitals machine were brought to him. He presented with SOB, confusion, lightheadedness. Exam demonstrated acute distress, speaking in staccato sentences. HR in 80s, with lungs CTAB and no stridor - despite increased RR to 20s. Vitals with HR in 70s, SpO2 remained 97% or greater on RA. BP was initially 140/72. A code blue was called and Drs. presented to the area. Patient c/o itchy throat and still p/w confusion/combativeness, loss of orientation, and SOB. No visible swelling noticed. At around 13:58, patient syncopized. HR and SpO2 remained 70-80s and >98% on room air respectively. Pulse remained palpable. At that time, an epipen was administered. Patient woke up. During the entire episode, he was able to recognize a staff member with whom he was previously familiar. EMS arrived, vitals remained stable. EMS transported patient to the ER for further monitoring and f/u. Concern for immediate allergic reaction 2/2 vaccination. After event, patient in need of referral to allergy provider for evaluation prior to consideration of 2nd dosage.
66 2021-02-13 disturbance in attention, thinking abnormal, impaired work ability see other boxes
66 2021-02-15 sleep disorder Woke up at 12:30 am feeling hot. couldn't sleep. At 3am took Advil 200mg. Fever at 8am = 99.5.
66 2021-02-16 feeling abnormal Terrible pain left shoulder (deltoid) terrible flu like symptoms, felt like throwing up. .. bad en... Read more
Terrible pain left shoulder (deltoid) terrible flu like symptoms, felt like throwing up. .. bad enough symptoms that I called 911 fever of 103.1 for a few hours. This woke me up at 2:30 am Now at about 12:30 pm arm still sore but most other symptoms gone away, but still feel like I got hit by a truck.
66 2021-02-18 feeling abnormal Diarrhea, fogginess, and large red, swollen, warm,painful area about 5 inches below injection site o... Read more
Diarrhea, fogginess, and large red, swollen, warm,painful area about 5 inches below injection site on left arm.
66 2021-02-18 loss of personal independence in daily activities -Approximately 5 hours after injection, developed 12 hours of chills (no fever), diffuse aching, fat... Read more
-Approximately 5 hours after injection, developed 12 hours of chills (no fever), diffuse aching, fatigue, and very low energy. -Approximately 3 days after vaccine noted difficulty completing usual daily exercise routine-stamina appeared low. -Approximately 3-5 days after vaccine noted difficulty completely taking in deep breath, with "catch" or discomfort in substernal area. -During early morning hours of day 7 after vaccine, was awakened with sharp, intense toothache pain right flank. With change of position was able to get comfortable after which pain resolved. This reoccurred the next two nights prompting ED visit. -First ED visit focused on right flank pain and CT Abdomen and pelvis was negative except for "atelectasis" right lung base -Due to more pleuritic symptoms, second ED visit occurred, and CT chest with contrast demonstrated bilateral PEs (approximately 5 on right and 2 on left) with evidence for RV strain -Hospitalized and started on anticoagulation (Lovenox SQ for one dose and then Eloquis). Echocariogram confirmed mild RV dilatation. Interventional Radiology did not feel removal/lysis of clots necessary. -Completed exhaustive evaluation with Hematology--no underlying clotting disorder identified to date -Have returned to 100% activity without significant symptoms at present
66 2021-02-18 poor quality sleep 31 hours after the shot all of a sudden I started to get very jittery and started having chills. I a... Read more
31 hours after the shot all of a sudden I started to get very jittery and started having chills. I ate a banana and a glass of milk. The jittery feeling subsided in about an hour. The chills remained and I got flushed and felt like i had a temperature. My joints in my hands felt very sore and during the night my body muscles felt wore out. My left shoulder at the site of the shot was throbbing bad. For some reason I had to urinate every hour for the next five hours of the night without ingesting any more fluids. By 7:00 AM I got to feeling progressively better and by 9:30 AM I felt like I had just had a very poor nights sleep. No more chills, fever, being flushed and the pain in my arm subsided substantially.
66 2021-02-19 nervousness Patient received his injection at 12:20 pm. He was observed for 15 minutes and released. Almost an... Read more
Patient received his injection at 12:20 pm. He was observed for 15 minutes and released. Almost an hour later he was still grocery shopping in the store he stated he very rapidly became dizzy almost like vertigo, began to feel shaky and sought a chair to sit down. He quickly became very nauseous and found a nearby trashcan to vomit but states he could only dry heave 3 or 4 times. He became quite pale and sweaty. He was observed by his wife accompanying him who is an RN. After appoximately 15 minutes the patient began to feel somewhat better. He was given a bottle of water to drink and he could sip it successfully . He was able to stand successfully and walked back to the pharmacy where I checked his blood pressure (136/86) and pulse (68). He refused a 911 call and said he felt about 95/100. Will check on patient again later this afternoon. Patient will check with his doctor before getting the second vaccine.
66 2021-02-21 memory impairment, feeling abnormal, disorientation About 60-90 minutes post injection he began to feel bad. Voice became very raspy, felt weak, felt li... Read more
About 60-90 minutes post injection he began to feel bad. Voice became very raspy, felt weak, felt like someone was chocking him. Extremely diaphoretic, felt very hot, had to remove shirt. Felt SOB, Called 911 with EMT response. BP 220/160, declined transport to ED, went home with family. BL more stable by 2100 that day. Day after shot blood sugar elevated at 220, normally 150/180.ALso vomiting clear fluids. Still not feeling well 4 days later, feels like "in another world", feels weak at times. Feels dizzy. Has and "eerie" feeling. Feels "equilibrium is off". Took Benadryl on 2/20. Has some disorientation "forgot what he was doing" at one point. Cramps in bilateral legs, both thighs and calves. Has headaches, migraine like at 3am without an elevated BP. Encouraged to see PCP, has appointment with physician on 3/2
66 2021-02-23 panic reaction, feeling abnormal, disorientation, hallucination, nervousness Very disoriented he was like he was looking into space, shaking, very nervous, panicky, afraid to ... Read more
Very disoriented he was like he was looking into space, shaking, very nervous, panicky, afraid to drive, seeing things, felt like he was having a heart attack. Hosptial did tests for his heart everything was fine with his heart. They said it may be from the shot. For him to go to his primary doctor. The doctor said not to get the second shot. Patient's first shot was 2/12/2021 and he still has the effects it?s going on two weeks .
66 2021-02-24 feeling abnormal I started by getting a modest headache in the early afternoon. About 3 PM feeling fatigued. About ... Read more
I started by getting a modest headache in the early afternoon. About 3 PM feeling fatigued. About 5 PM I began getting chills. By 7 PM headache became a bit stronger, and loss of appetite; becoming more fatigued; generally just feeling "crummy". About 8 PM I took prescribed amount of regular strength Tylenol, and went to bed, easily falling asleep. Woke about 7 AM next day feeling noticeably better. I took another dose of Tylenol, just as a precaution. I would say by 11 AM all illness was gone.
66 2021-02-27 feeling abnormal I had very severe cf starting in 1996. It remained severe for approximately 5 years after which it ... Read more
I had very severe cf starting in 1996. It remained severe for approximately 5 years after which it was semi acute for another 5 years. After that i would have periodic relapses several times a year for varying lengths of time. For the last 10 years irt has been much better with occasional symptoms. However i received my second dose of the Moderna vaccine on february 23, 2021 and had a strong flu like response. I am now experiencing a mild to moderate relapse of my cf. brain fog, difficulty tracking with my vision, chills, etc. when i had severe cf i had this symptom where my scalp would feellike it was in a spasm. That has returned. I have dealt with tcf long enough to know when it occurs and this is definitely a response to the covid vaccine.
66 2021-02-27 sleep disorder Shot administered on 2/15/21 Monday @ 5:30 PM. On 2/23/21 @ 5:30 AM Tuesday, I woke up with an itch... Read more
Shot administered on 2/15/21 Monday @ 5:30 PM. On 2/23/21 @ 5:30 AM Tuesday, I woke up with an itching at the area of the injection site. The site where the injection was given had bruised and is now fading and is a yellowish color. Directly below the injection site and its bruised area is a hot feeling, itchy red rash. Through the course of the day, the red rash has increased in size, approximately 3.5 inch in diameter. The same day around 5:30 PM I begin to feel a pain/ache in right shoulder and up into my neck on the right side. The pain level gains and the level of pain reaches 5 in about two hours. The aching seems deep beneath the shoulder bone and into the spine of the neck. The rash and pain remain to present, 2/28/2021 Sunday. The rash maintained the same side and began to slowly disappear yesterday, 2/27/2021 Sunday late evening. The pain was at it's worst with arm and shoulder movement but was worse, even without movement of the arm and shoulder between 2/26/2021 Friday and 2/27/2021 Saturday, even when in bed, interrupting my sleep. On 2/27/2021 Saturday evening the red rash had noticeable fading and the pain level began to decrease. Today 2/28/2021 the red rash is almost goin and the neck and shoulder pain is no worse than level 1.
66 2021-02-28 delirium STROKE LIKE SYSTEMS /FATIGUE/ WEAKNESS IN LEG AND ARM JOINTS/LOS OF BALANCE/ DELIRIUM.
66 2021-03-03 confusional state Patient was admitted for confusion and difficulty getting words out. Imaging studies showed a lesion... Read more
Patient was admitted for confusion and difficulty getting words out. Imaging studies showed a lesion in the left frontal lobe and neurosurgery was consulted. Neurosurgery believed lesion was possible an acute/subacute infarct however morphology was unusual. Patient's symptoms resolved and he was discharged, instructed to follow up with neurology and PCP. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
66 2021-03-03 feeling abnormal Patient was given Moderna vaccination and was waiting in the post-vaccine area. Patient reported to ... Read more
Patient was given Moderna vaccination and was waiting in the post-vaccine area. Patient reported to the associate that he was feeling funny. The pharmacist was called and the patient reported feeling light headed and dizzy. While talking the pharmacist the patients eyes rolled back in his head. The pharmacist held his shoulders and his hand and continued to speak to the patient. He regained consciousness. The patient was able to move to his knees and then to lie on his back on the floor with his feet elevated. The injection site was clear and smooth. He had no fever. After resting 15 minutes his color improved and was conversing well. He was able to sit up and his blood pressure was taken. His blood pressure was within normal range. He sat for another 15 min and drank some juice. He was feeling well enough to go home in the care of his wife.
66 2021-03-03 feeling abnormal Moderna Vovid-19 Vaccine EUA Got Vaccine at 10am that morning and by 9pm patience was having chill... Read more
Moderna Vovid-19 Vaccine EUA Got Vaccine at 10am that morning and by 9pm patience was having chills, fever, balance issues, muscle aches. It felt like a bad case of the FLU. It lasted until the next day about 8pm.
66 2021-03-05 sleep disorder Inability to sleep each night since receiving vaccine, 4 nights so far.
66 2021-03-09 sleep disorder The night after the vaccine I woke up about 2:30 a.m. with general body pain (all over), at about 9:... Read more
The night after the vaccine I woke up about 2:30 a.m. with general body pain (all over), at about 9:00 a.m. my body wide pain and headache and fever became excruciating and I was in bed and unable to function. I drank liquids all day and about 4 p.m. took two 650mg acetomiaphin pan killers. At 6:30 p.m. the fever broke and the pain and agony went down. This was a very intense pain event (top 5 in my life!). Now, at 8:16 p.m. I am coming back to normal.
66 2021-03-13 irritability lethargy and irritability
66 2021-03-15 impaired work ability very sore arm around injection site, very achy, fatigued, felt terrible over all, cold not work, th... Read more
very sore arm around injection site, very achy, fatigued, felt terrible over all, cold not work, the next day, about 50 % better, the third day was back to normal.
66 2021-03-15 memory impairment Narrative: ON 3/9/21--RECEIVED VACCINE DOSE#1 OF THE MODERNA,APPROX. 0915AM PT STATED HE WENT STRAIG... Read more
Narrative: ON 3/9/21--RECEIVED VACCINE DOSE#1 OF THE MODERNA,APPROX. 0915AM PT STATED HE WENT STRAIGHTHOME--THAT EVENINGPATIENT STATED HAD COLD CHILLS--PT STATED HE THOUGHT IT WAS THE BEGINNING OF THE FLU, BODY WAS HOT. ON 3/10/21-- IN THE AM FEELING SLLUGGISH/WEAK/NO ENERGY, WAS BABYSITTING GRANDSON, IN THE AFTERNOON WENT TO LAY DOWN. (PATIENT DOES NOT REMEMBER THE REST OF THE EVENTS--REPORTED TO HIM LATER BY SPOUSE OF WHAT HAPPENED) PT FOUND GURGLING BY SPOUSE, WIFE CALLED SON-IN-LAW, HE CAME IN BUT AT THE TIME PATIENT HAD STOPPED BREATHING, HE STARTED CPR ON THE PATIENT, AND SOMEONE CALLED 911. PATIENT WOKE UP IN THE AMBULANCE.
66 2021-03-16 feeling abnormal In addition to the normal vaccine reaction such as Chills, heavy head, nausea, etc. I had severe di... Read more
In addition to the normal vaccine reaction such as Chills, heavy head, nausea, etc. I had severe diarrhea for 2 days. was able to resolve with 3 pills of imodium over a time period of 15 hours
66 2021-03-16 excessive sleepiness Very tired and sore-like been hit by a truck--very very weak--lasted 24 hours-- I slept for about 20... Read more
Very tired and sore-like been hit by a truck--very very weak--lasted 24 hours-- I slept for about 20 hours
66 2021-03-20 insomnia joint pain, swelling arm/feet/legs/neck, headache, lower back pain, blurry eye, insomnia, neuropathy... Read more
joint pain, swelling arm/feet/legs/neck, headache, lower back pain, blurry eye, insomnia, neuropathy in arms and legs, itchy
66 2021-03-22 sleep disorder, loss of personal independence in daily activities My left arm is in excruciating pain I cannot use nor could I sleep first night. Arm is almost dead i... Read more
My left arm is in excruciating pain I cannot use nor could I sleep first night. Arm is almost dead in some ways. I cannot life past my mouth as cannot even extend very well. Severe pain, aching also pain down shoulder into right hand. I have tried icing, heat, applied Cold spray. It is slightly painful 2 days later but still lots of pain. I cannot use arm to do chores. Even brushing teeth was hard. Arm was fine till 10 hours later then became worse and worse. Plus have little strength in arm. I cannot use arm to dry myself after shower. Arm continues to be painful, aspirin does nothing to alleviate pain. I regret getting vaccine and have doubts to complete series as I heard second shot worse. I have not sought treatment yet but may go see my PCP this week.
66 2021-03-23 excessive sleepiness Tiredness, Chills, Joint Pain, Mild Nausea. I started getting the chills during the night (night of... Read more
Tiredness, Chills, Joint Pain, Mild Nausea. I started getting the chills during the night (night of receiving my second dose), and was cold most of the next day. I was very tired, slept most of the day, and felt some joint pain and mild nausea. I woke up today (second day after second shot) feeling a little tired, but basically fine, without symptoms.
66 2021-03-23 sleep disorder By 9:00 pm the evening of my vaccine I was having chills and a fever of 100 degrees. Not that high I... Read more
By 9:00 pm the evening of my vaccine I was having chills and a fever of 100 degrees. Not that high I know but for me it is and gave me a very bad headache and body aches. I did not feel good enough to try to sleep until about 1:00 am after using a heating pad and hot tea to try and chase the chills away and Ibuprofen for the aches. My shoulder was so sore from the shot that I could not lay on my left side. The following day I was about 50% better. No more chills but still slight fever and no appetite. Didn't feel good enough to do anything except take a nap. The following day I was pretty much back to normal.
66 2021-03-24 sleep disorder About 6 hours after injection, onset of headache, body ache, general overall lethargy. Then sleep in... Read more
About 6 hours after injection, onset of headache, body ache, general overall lethargy. Then sleep interrupted by chills, and then sweats (so much so that had to lay down a towel and another towel for my pillow). The next day was dominated by body aches and headache (I rarely get headaches). Loss of appetite. This general condition of malaise lasted all day (the day after injection) and it was at times horrible. The symptoms started to subside by the evening hours and I was able to have a better night sleep. By the next morning I felt better.
66 2021-03-25 mental status changes, suicidal thoughts 03/24/21: Patient presented and was admitted through emergency department for Altered mental status ... Read more
03/24/21: Patient presented and was admitted through emergency department for Altered mental status and Suicidal ideations. PMH Charcot foot requiring multiple surgeries in the past, paroxysmal afib on Eliquis, stage III CKD, type II DM, HTN, HLD, previous stroke, blind in right eye. On admission pertinent objective findings: XR foot - Cortical erosion over the bony prominence of the right medial midfoot concerning for osteomyelitis Hospital diagnosis: Right foot with large open wound, suspected osteomyelitis of right foot. CT scan of his head shows no acute finding. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine. Hospital diagnosis:
66 2021-03-29 restlessness, disorientation I received the second vaccine injection, and in about an hour felt a little warm and clammy, I was h... Read more
I received the second vaccine injection, and in about an hour felt a little warm and clammy, I was having some joint and muscle pain, and stomach upset. I had no appetite and did not eat lunch. At supper I still did not want anything, so ate cereal instead. During the night I was restless, and expelled quite a bit of gas throughout the night. Stomach still uneasy. When I awoke, about 6:00 AM, I was hungry and attempted to pour a bowl of cereal but could not due to shaking. My wife found me in the middle of a grand mal seizure and called the ambulance. The ambulance, police, and fire company all responded. They provided medical care onsite and in route to Hospital. I had a fever of 102 degrees, had been biting my tongue raw, flailing arm and hyperventilating. I was somewhat disoriented and delusional. During my hospitalization the injection site was found to be very swollen and red. Ice was applied. An MRI was performed of the head and found to be normal. Several other blood tests were also completed. I remained inpatient from 3/25/21 through 3/21/21.
66 2021-03-30 loss of personal independence in daily activities I developed severe tinnitus after receiving the second Moderna vaccine and it has not subsided. It's... Read more
I developed severe tinnitus after receiving the second Moderna vaccine and it has not subsided. It's interfering with my daily life and has adversely affected the quality of my life. Today I'm going to see an ENT doctor for evaluation. Now I see and hear that many people are experiencing the same loud ringing tinnitus after receiving the Moderna vaccine. I can only make the correlation that the loud ringing that goes on 24/7 began after getting the vaccinations.
66 2021-03-30 poor quality sleep, loss of personal independence in daily activities At about 11 pm on 3/26/21, patient experienced uncontrollable chills. He did not sleep well. On 3/... Read more
At about 11 pm on 3/26/21, patient experienced uncontrollable chills. He did not sleep well. On 3/27/21, he got a fever that ranged between 99.7 to 102.6. He could not eat and thinking about it made his stomach upset. Every bone and joint in his body ached, even his skin hurt and he had a bad headache. Tylenol did little to alleviate any of these symptoms. His fever broke on 3/27/21 about 11 pm. He still did not sleep well and slept until noon on 3/28/21. His symptoms persisted except for the fever, though he still had chills that night. He still did not feel well throughout 3/29/21 and 3/30/21 and he still ate very, very little until 3/31/21. On 3/31/21, he was able to eat and went to the grocery, but it wiped him out and he slept for a couple of hours in the afternoon. He still has a dull headache and very little energy that is keeping him from doing his daily activities.
66 2021-03-31 feeling abnormal Monday 2/29 in the morning felt a little dizzy Tuesday 2/30 in the morning felt something was not r... Read more
Monday 2/29 in the morning felt a little dizzy Tuesday 2/30 in the morning felt something was not right. Felt a little more dizzy Wednesday morning had full blown vertigo. So bad I could hardly stand up. Never in my like had I ever had vertigo. At 3:00 pm Two Doctors adjusted the left ear twice to get the crystals right. No issues with the right ear. The left ear is the one I have ringing in. Had to use a neck brace for 2 days and slept in a chair for two night. No more dizziness. But for 4 weeks was not myself
66 2021-04-03 excessive sleepiness Very sleepy, slept most of the day. Had chills and fever of 102. Injection site was very sore. Blood... Read more
Very sleepy, slept most of the day. Had chills and fever of 102. Injection site was very sore. Blood sugar levels were very high (over 300) and did seem to respond to more insulin.
66 2021-04-04 confusional state After vaccination, patient became hypertensive started vomiting and became confused.
66 2021-04-06 sensation of foreign body 3 min after vaccination, pt complained of blurry vision. endorsed tingling down his back and arms. f... Read more
3 min after vaccination, pt complained of blurry vision. endorsed tingling down his back and arms. felt he was getting very hot. itching down back of his head into his arms. reported pain in his throat, dificulty swallowing, felt like something was stuck in his throat. felt he had an upset stomach but did not think he was going to vomit. denied trouble breathing in his chest. no lip swelling, no eyelid swelling, no hives. pulse regular. 74. BP 150/70. O2 sat 98%. 0.3mg Epi given to right thigh at 1432. pt complained he still had globus, still had blurry vision, itchiness and was feeling even hotter. BP 180/90 at 1435. reported "hammer to his head" headache at 1437. cotninued blurry vision and globus. BP 172/94 at 1438. 0.3mg Epi given to left thigh at 1438. 1440 pt getting very shaky, handoff given to ambulance.
66 2021-04-07 impaired work ability Three days after the vaccine , I experienced (more than mild)dizziness. Sluggish energy level, enoug... Read more
Three days after the vaccine , I experienced (more than mild)dizziness. Sluggish energy level, enough so,that Icould not go to my part time job. I went back to bed and slept off and on the rest of the day.
66 2021-04-07 mental status changes Patient received vaccine 3/2/2021, second dose. Uneventful. On 3/16, patient was found unresponsiv... Read more
Patient received vaccine 3/2/2021, second dose. Uneventful. On 3/16, patient was found unresponsive and sent to hospital. Hospital course: altered mental status, pneumonia, acute hypoxia, acute encephalopathy. Treated in hospital, recovered and returned to nursing home. Patient tested negative for Covid on 3/16/21 before transfer to hospital. Before sent to hospital vitals were: Temp 101.7, pulse 104, BP 130/78, blood sugar 172, oxygen on room air 95%.
66 2021-04-08 loss of personal independence in daily activities, feeling abnormal He got the vaccine and began with chills, body aches, joint aches, complete brain fog (out of it), f... Read more
He got the vaccine and began with chills, body aches, joint aches, complete brain fog (out of it), fever to 100 (normal is 95.5), extreme fatigue (could not get out of bed) which lasted for 3 days. After 24 hours he continued with the nausea, body aches and cannot shake the brain fog feeling. Had lingering effects of nausea for 10 days, now being the 15th day he is still tired, still has body aches not his usual symptoms and feels a little out of it, brain fog. Not back to where he was before the vaccines. He took Tylenol for his symptoms. He did call his cardiologist who informed him that they would go away, which was over a week ago. He took a long bike ride 2 days ago, 4/7/21 but he was extremely fatigue other than his normal and not able to function the next day.
66 2021-04-09 feeling abnormal, impaired work ability About 14 hours after receiving my second shot of the vaccine, I awoke being very cold and began to s... Read more
About 14 hours after receiving my second shot of the vaccine, I awoke being very cold and began to shiver and shake almost violently after getting out of bed to urinate. Also my back, hips and knee joint were aching when I moved about any at all. I was able to fall back to sleep and in the few time I awoke during the rest of the night, I didn't experience the shaking, however, with the aching and feeling cold, it was reminiscent of times when I had a fever. Unfortunately, I do not have a working thermometer, so I could not check this, but I suspect I did have a fever. I was also experiencing a sort of mental brain fog of confusion and lack of full consciousness (felt like I could not bring myself awake enough to do much of anything). The following morning, I was barely able to become awake enough and clear headed enough to send an email to my boss about having to miss work. Except to get out of bed for a short time to use the bathroom or get something to drink, I slept most of Friday until late afternoon. Then I was slightly more coherent and was able to get more to drink and eat. But still sleepy and went back to sleep. I awoke in a sweat (not experienced before this time) and felt a little clearer in my mind and not as achy. Slept again later through the night, but continued to wake up in a sweat during the night. Finally this morning when I awoke, I felt more normal again.
66 2021-04-10 insomnia I had almost identical problems even after the first injection which lasted 2 1/2 days that time. Th... Read more
I had almost identical problems even after the first injection which lasted 2 1/2 days that time. This time, the second dose, affects were even worse. Injection site was sore almost immediately and started to get muscle pain in back of neck,gradually started aching with headache over time. About 8hrs after injection temperature started,my normal temp is 97-97.6 it went up as high as 102.8 & stayed above 99.4 for approximately 36hrs. Also had swelling of left side of face,left had noticeable swelling under it. At same time aches & pain got worse including chills & sweating which made sleeping impossible. Took aspirin to break fever which didn?t come down till 2 days after shot. By third day was still achy and extremely rundown. Will absolutely NOT go through this ever again:especially with the Moderna vaccine!
66 2021-04-10 irritability Severe hand tremors, weakness in legs, fatigue, irritability-ongoing since right after the second sh... Read more
Severe hand tremors, weakness in legs, fatigue, irritability-ongoing since right after the second shot. 1 incident of vomiting.
66 2021-04-11 feeling abnormal I woke up the next morning with a fever (99) and felt a little foggy. I spent the day sleeping and... Read more
I woke up the next morning with a fever (99) and felt a little foggy. I spent the day sleeping and taking ibuprofen for the fever. Later that evening I was feeling a little better so I went to do a karaoke show. At 11:00 pm I was on my way home when I blacked out , ended up in a ditch on the side of my vehicle which was totaled.
66 2021-04-12 mental impairment Driving home after waiting period, shaking uncontrollable until arriving at destination. Patient was... Read more
Driving home after waiting period, shaking uncontrollable until arriving at destination. Patient was shaking for over an hour but less than an hour and a half, after felt lethargic/cold. Hard time thinking and felt ill. Headache and pain in head.
66 2021-04-12 sleep disorder I received my 2nd Moderna vaccine shot on Wednesday at noon and wanting to report that starting abou... Read more
I received my 2nd Moderna vaccine shot on Wednesday at noon and wanting to report that starting about 11AM on Thursday I started experiencing fever type of feeling. By 3PM I was knocked out with a fever of 99.4 and felt generally lousy with no appetite. Had difficulty sleeping throughout late PM, evnening and overnight . up every 2.5 hours. Fever is normal this morning but lagging effect of fever and general weakness remains.
66 2021-04-13 mental impairment, excessive sleepiness very tired mental slowdown sore throat hoarse voice lots of sleep
66 2021-04-16 loss of personal independence in daily activities At 2 am the patient woke up feeling numbness in his hands and fingers. He was unable to preform dail... Read more
At 2 am the patient woke up feeling numbness in his hands and fingers. He was unable to preform daily tasks like buttoning his pants. He has started to regain strength but says that the numbness feeling is still present
66 2021-04-19 sleep disorder Arm in constant pain. "It doesn't go away". Unable to sleep on arm. Ices arm to sleep. "Once I lay d... Read more
Arm in constant pain. "It doesn't go away". Unable to sleep on arm. Ices arm to sleep. "Once I lay down, it becomes a pulsating pain". Pt saw general practitioner about arm twice within the last 8 wks, and GP put pt on a magnesium supplement. Also uses Biofreeze ointment and Voltaran gel, which provides temporary relief.
66 2021-04-23 insomnia About 5 days after receiving my first shot I was in the ER and diagnosed with chronic insomnia. I h... Read more
About 5 days after receiving my first shot I was in the ER and diagnosed with chronic insomnia. I have trouble sleeping ever since.
66 2021-04-24 impaired work ability, sleep disorder Possible COVID Vaccine Reaction Introduction I am writing this because I think all of the issues de... Read more
Possible COVID Vaccine Reaction Introduction I am writing this because I think all of the issues described under the ?Current Situation? section may somehow be tied to an adverse reaction to my second COVID shot. Until today, I had thought they were separate incidents with no common thread. I now can see the possibility that they may be related. I am asking for competent and engaged medical help to determine whether this is so, and if not, what the causes are for my issues. I will give a brief medical history to give some current perspective. Health History Current Vital Statistics ? Age: 66, Gender: Male, Height: 6?3?, Weight: 245 Hemorrhoidectomy ? In 1999 I had a hemorrhoidectomy to stop episodes of severe bleeding. Heart Attack ? In August 2000 I had a heart attack, diagnosed as unstable angina, while on vacation. They did further tests, found blockages and inserted stents in two arteries. I was sent home with instructions to contact a cardiologist. AICD ? After returning home, my new cardiologist did further tests and found evidence of ventricular tachycardia. I was sent to a specialist who did an electrophysiology study and immediately implanted an AICD. I have had it replace twice, with the latest one in April 2012. It has never gone off. There are close to five years left on my current battery. Knee Replacement ? In January 2015 I had a total knee replacement of my right knee. That was a result of several injuries and four surgeries, which left the knee without cartilage. The knee replacement has worked flawlessly, and I am able to pursue athletics, especially playing tennis, without limitation. Current Situation February 23 ? Received my first shot of the Moderna vaccine in my right arm. Other than minor soreness around the injection site, I had no other reaction. March 29 ? Received the second shot of the Moderna vaccine in my right arm. Again, there was minor soreness around the injection site. April 2 ? Had major pain in my tightness in my chest and major pain starting in my left shoulder and radiating down my left arm. It caused significant discomfort, and I was awake a large part of the night deciding whether I need to call 911 for a possible heart attack. I decided against that and instead went to urgent care in the morning (April 3). My EKG was normal, my blood pressure was elevated (158/96 sitting, 157/91 standing). Doctor could find nothing to suggest heart attack. Prescribed a course of Prednisone for the shoulder/arm pain. Had blood work ordered, which all came back normal. April 5 ? Played doubles tennis as usual. Noticed some weakness in my left shoulder and arm but played through it successfully. The pain level was very low. April 10 ? Played doubles tennis again. From the first ball I hit I was aware of major weakness in my shoulder and arm. They had no power at all, and I was almost unable to get my serve over the net. I played through it again and played very poorly. The interesting thing was that the pain and weakness did not worsen during the play or afterwards. The pain remained after I had finished playing. April 11 ? Chatted with the athletic trainer while I was officiating their women?s tennis match to look for clues as to what might be wrong. He suggested in may be a shoulder impingement. April 15 ? Had a phone consult with my primary care doctor. I suggested the possibility of the shoulder impingement and he was willing to start there since this was a phone visit. He referred me to orthopedics and physical therapy and prescribed meloxicam for pain. The pain has continued unabated during this time. April 21 ? Pain level was very high to the point where I was unable to work. Went home and slept most of the day. Meloxicam was not having much impact on the pain compared to my usual regimen of both acetaminophen and ibuprofen (which I had stopped using when I was taking the meloxicam). After this I stopped the meloxicam and went back to the other drugs as required. I had an initial visit with the physical therapist that afternoon. She did not find anything which would suggest a rotator cuff or labrum injury. Range of motion was normal. She noted weakness in my left side compared to my right, which is unusual since I am left-handed. She gave me three exercises to do daily. April 23 ? Pain had been back to a more tolerable level. I had a COVID test in the morning for a treadmill test I have next week, and also got an x-ray of my shoulder as requested by my primary care doctor. After I went to bed, I had an incident of severe incident of chills which left me freezing and short of breath even with sweats on under my bed covers. I called my wife in to check my vitals. My blood pressure was a bit higher than normal but not critical. My blood oxygen was 98 and my pulse was 70. My temperature was 99.7 with an oral thermometer. We called the after-hours nurse hotline and spoke with a nurse. By that time, it had been about 30 minutes of chills and they were subsiding. She said she would have a doctor call in the next couple of hours. The doctor called back, and after going over everything, said to come in if the symptoms reoccurred. Thankfully they did not. All the while I am still having the pain in my left shoulder and arm. April 24 ? Again, slept most of the day due to being worn out from the previous night issues and lack of sleep. No change in the pain and discomfort.
66 2021-04-25 feeling abnormal, anxiety PATIENT CALLED TODAY 4/26/21 CONCERNED ABOUT THE SECOND SHOT IN THE MODERNA VACCINE SERIES. HE STAT... Read more
PATIENT CALLED TODAY 4/26/21 CONCERNED ABOUT THE SECOND SHOT IN THE MODERNA VACCINE SERIES. HE STATED THAT AFTER THE FIRST DOSE ON 4/20/21 HE EXPERIENCED A FEELING OF BEING OVERWHELMED THAT LASTED ABOUT 3 HOURS. HE FELT A SENSATION OF THROAT AND LIP SWELLING, TINGLING OF THE TONGUE AND FEELING OF DISCOMFORT. PATIENT STATED THAT HE HAS HAD REACTIONS TO POLYETHYLENE GLYCOL IN THE PAST.
66 2021-04-26 feeling abnormal tinnitis, measurable hearing loss, headache, "brain fog"
66 2021-04-26 mental status changes Patient presented to the clinic diaphoretic with slurred speech, altered mental status and significa... Read more
Patient presented to the clinic diaphoretic with slurred speech, altered mental status and significant weakness unable to walk or bear weight. He was sent out 911 for hospital evaluation. He was admitted and was in the hospital for 48 hours. Acute CVA was ruled out. Within 48 hours after presentation of symptoms he was back to baseline.
66 2021-04-30 irritability, abnormal behaviour, thinking abnormal Acting really weird; Irritable; Wasn't thinking clearly; This spontaneous case was reported by a pat... Read more
Acting really weird; Irritable; Wasn't thinking clearly; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ABNORMAL BEHAVIOUR (Acting really weird), IRRITABILITY (Irritable) and THINKING ABNORMAL (Wasn't thinking clearly) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABNORMAL BEHAVIOUR (Acting really weird) (seriousness criterion hospitalization), IRRITABILITY (Irritable) (seriousness criterion hospitalization) and THINKING ABNORMAL (Wasn't thinking clearly) (seriousness criterion hospitalization). At the time of the report, ABNORMAL BEHAVIOUR (Acting really weird), IRRITABILITY (Irritable) and THINKING ABNORMAL (Wasn't thinking clearly) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 25 Mar 2021, approximately 3 hours post vaccination, the reporter stated the patient lost his mind. The patient barrowed $6,000 for a motorcycle. Road the motorcycle into a snow storm. Went to jail for riding the motorcycle 130 miles per house. Has been scattered brain, incoherent. Tore up the vaccination card, threw hearing aids away, along with credit cards and cell phones. The reporter stated, the patient has been hospitalized in 3 psychiatric hospitals and at the time of this report, was hospitalized in one. On 21 Apr 2021, the patient was normal for approximately 20 hours but resumed acting weird. The patient experiences brain fog in which he can't talk, had no refluxes, can't move but is able to hear. 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 (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.
66 2021-05-02 sleep disorder Developed a rash 2 days after - blistery rash. Started on arms, then chest, and spread to rest of th... Read more
Developed a rash 2 days after - blistery rash. Started on arms, then chest, and spread to rest of the body. Was itchy, the blisters scabbed over and now is getting more blisters again. Rash was stinging and was not able to even sleep. Seen by CNP and then a few days later went to the ER -received antibiotics and steroids.
66 2021-05-03 abnormal dreams Strange dreams during which I physically grab/shake/pull hair of my wife in bed. Never did this pri... Read more
Strange dreams during which I physically grab/shake/pull hair of my wife in bed. Never did this prior to vaccine. Has happened at least 5 times since vaccine. Latest event occurred 5/4/21
66 2021-05-05 suicidal thoughts, mental impairment on 2/14 he woke up and couldn't move his left side, couldn't walk. Went to ER, numerous tests were ... Read more
on 2/14 he woke up and couldn't move his left side, couldn't walk. Went to ER, numerous tests were run and there was nothing to substantiate. ER suggested to follow up with neurologist, neurologist said possibly Parkinson's. Went to more dr's, they don't think Parkinson's. Started getting better a few days before the second dose, got the second dose on 2/25. After the second things everything was exscaberated, weight started dropping, started losing muscle tone, appetite, and extreme fatigue. Cognitive thinking was gone,almost like a psychosis, was suicidal, couldn't think straight. Went back to the Er, couldn't find anything. They admitted him to observe and could find nothing. We came home and continually
66 2021-05-13 insomnia TINNITUS LEFT EAR - SUDDENLY 10 Days AGO - SEVERE - KEEPS LIP @ NIGHT
66 2021-05-19 mental status changes Encephalopathy; Pneumonia; Hypoxia; Unresponsive to stimuli; Mental status changes; This case was re... Read more
Encephalopathy; Pneumonia; Hypoxia; Unresponsive to stimuli; Mental status changes; This case was received via FDA VAERS (Reference number: 1182714) 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 ENCEPHALOPATHY (Encephalopathy), PNEUMONIA (Pneumonia), HYPOXIA (Hypoxia), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) and MENTAL STATUS CHANGES (Mental status changes) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. Concurrent medical conditions included Epilepsy, Dementia, Hypertension, Diabetes and Benign prostatic hyperplasia. Concomitant products included AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM/VITAMIN D [CALCIUM CARBONATE;ERGOCALCIFEROL]), CARBAMAZEPINE, CARVEDILOL, DONEPEZIL, FINASTERIDE, GABAPENTIN, HALOPERIDOL, HYDRALAZINE, INSULIN, LEVETIRACETAM, LISINOPRIL, OXYBUTYNIN, POLYETHYLENE GLYCOL 3350, TAMSULOSIN and SENNA ALEXANDRINA EXTRACT (SENNALAX [SENNA ALEXANDRINA EXTRACT]) for an unknown indication. On 02-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 16-Mar-2021, the patient experienced ENCEPHALOPATHY (Encephalopathy) (seriousness criteria hospitalization, medically significant and life threatening), PNEUMONIA (Pneumonia) (seriousness criteria hospitalization, medically significant and life threatening), HYPOXIA (Hypoxia) (seriousness criteria hospitalization, medically significant and life threatening), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criteria hospitalization, medically significant and life threatening) and MENTAL STATUS CHANGES (Mental status changes) (seriousness criteria hospitalization and life threatening). At the time of the report, ENCEPHALOPATHY (Encephalopathy), PNEUMONIA (Pneumonia), HYPOXIA (Hypoxia), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) and MENTAL STATUS CHANGES (Mental status changes) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood glucose: normal (normal) normal and 172 172. On 16-Mar-2021, Blood pressure measurement: 130/78 130/78. On 16-Mar-2021, Body temperature: 101.7 (High) 101.7. On 16-Mar-2021, Heart rate: 104 104. On 16-Mar-2021, Oxygen saturation: 95 % 95. On 16-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment drug information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
66 2021-06-01 insomnia sick as a dog; Kidney's almost shut down both times; had 2-3 attacks; Unexplainable pain in lower st... Read more
sick as a dog; Kidney's almost shut down both times; had 2-3 attacks; Unexplainable pain in lower stomach area; Health declined quickly; Heart issue after first shot of vaccine; Lungs have gotten worse since the first shot; grabbing and pulling at his chest; Unable to sleep; Foul smelling diarrhea; Terrible chest pain; Could not breath/Very difficult to breathe; Could not eat anything; didn't take the second dose of the Moderna COVID-19 vaccine; Sick as a dog; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL IMPAIRMENT (Kidney's almost shut down both times), MYOCARDIAL INFARCTION (had 2-3 attacks) and ILLNESS (sick as a dog) in a 66-year-old male 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. Concurrent medical conditions included Peanut allergy, Fruit allergy (citrus allergy was reported.), Milk allergy (Dairy allergy was reported.), Drug allergy (demerol), Kidney disorder (Kidney disease was reported.) since 2008, Chronic pancreatitis since 2012, COPD since 2001, Heart disease, unspecified since 2000, Drug allergy (tramadol), Drug allergy (lorazepam), Food allergy and Food allergy. Concomitant products included ONDANSETRON, PANTOPRAZOLE, BUPRENORPHINE and SALBUTAMOL SULFATE (PROAIR HFA) for Chronic pancreatitis, LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]) for Hypertension, FLUOXETINE HYDROCHLORIDE (PROZAC) for Mood depression, AMMONIUM BROMIDE, POTASSIUM BROMIDE, SODIUM BROMIDE (BROMIDES), TIOTROPIUM BROMIDE (SPIRIVA) and DIAZEPAM (VALIUM) for an unknown indication. On 03-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RENAL IMPAIRMENT (Kidney's almost shut down both times) (seriousness criteria hospitalization, medically significant and intervention required), MYOCARDIAL INFARCTION (had 2-3 attacks) (seriousness criteria hospitalization, medically significant and intervention required), PRODUCT DOSE OMISSION ISSUE (didn't take the second dose of the Moderna COVID-19 vaccine) and ILLNESS (Sick as a dog). On 06-Mar-2021, the patient experienced ILLNESS (sick as a dog) (seriousness criteria hospitalization, medically significant and intervention required), DYSPNOEA (Could not breath/Very difficult to breathe) and FEEDING DISORDER (Could not eat anything). 06-Mar-2021, the patient experienced CHEST PAIN (Terrible chest pain). On 19-Mar-2021, the patient experienced DIARRHOEA (Foul smelling diarrhea). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Unexplainable pain in lower stomach area), GENERAL PHYSICAL HEALTH DETERIORATION (Health declined quickly), CARDIAC DISORDER (Heart issue after first shot of vaccine), LUNG DISORDER (Lungs have gotten worse since the first shot), CHEST DISCOMFORT (grabbing and pulling at his chest) and INSOMNIA (Unable to sleep). The patient was treated with TIOTROPIUM BROMIDE (oral) on 05-Mar-2021 at an unspecified dose and frequency; SIMETHICONE ongoing since an unknown date at an unspecified dose and frequency; PREDNISONE at a dose of 10 mg and OXYGEN at an unspecified dose and frequency. At the time of the report, RENAL IMPAIRMENT (Kidney's almost shut down both times) had not resolved and MYOCARDIAL INFARCTION (had 2-3 attacks), ILLNESS (sick as a dog), DYSPNOEA (Could not breath/Very difficult to breathe), FEEDING DISORDER (Could not eat anything), DIARRHOEA (Foul smelling diarrhea), ABDOMINAL PAIN UPPER (Unexplainable pain in lower stomach area), GENERAL PHYSICAL HEALTH DETERIORATION (Health declined quickly), CARDIAC DISORDER (Heart issue after first shot of vaccine), LUNG DISORDER (Lungs have gotten worse since the first shot), CHEST PAIN (Terrible chest pain), CHEST DISCOMFORT (grabbing and pulling at his chest), PRODUCT DOSE OMISSION ISSUE (didn't take the second dose of the Moderna COVID-19 vaccine), ILLNESS (Sick as a dog) and INSOMNIA (Unable to sleep) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal other. On an unknown date, SARS-CoV-2 test negative: negative negative. On an unknown date, Troponin: high (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient is on nebulizer treatment of tiotropium bromide and a lot of simethicone. Patient do not know if using either medication helped or not but that was my immidiate reaction. Now patient is on prednisone and feels like he's taking it just to breathe. Patient has had to go on 24 hr. oxygen since the first shot. Patient was negative for Covid-19 over the past 3 months at three different times. He continued to have terrible chest pain where he was grabbing and pulling at his chest, pain creeping up to his chest, could not breath or eat anything for 1 week after his first shot. Patient was in the ER on 10Mar2021. Caller stated he has chronic pancreatitis and breathing issues for which he was prescribed steroids, his doctor told him to decrease the prednisone to 10mg for 2 days prior and day of vaccination. Caller thinks he had a week long stroke since he had high Troponin level which resulted in visit to the hospital where the doctors thought he had septicemia. Caller stated he has not been able to sleep because he keeps having attacks of chest pains that last approximately 15 minutes in the middle of the sleep which occurs 4+ times per night. Kidney's have gotten worse since 1st shot vaccine. Doctors said "the kidney's took a shot" after the first shot of vaccine. Patient was admitted to the Hosp twice after the first shot because his kidneys almost shut down both times. Unexplainable, excruciating pain in chest and very difficult to breathe for approx. 10-15 minutes each attack. New, unexplainable pain in lower stomach area since 1st shot of vaccine. Doctors cannot explain. Patient is seeking legal action against Moderna. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18 May 2021,included patient demography (Ethnicity, race, height, weight), allergy to peanuts, citrus, dairy, Demerol, tramadol, lorazepam. Current medical condition kidney disease was updated. concomitant medications were buprenorphine, pantoprazole, ondansetron, losartan, Prozac with product indications were updated. Laboratory information EKG was updated. Events Kidney's have gotten worse, unexplainable pain in lower stomach area, my health has declined, lungs have gotten worse was updated. On 23-May-2021: follow-up appended, conmeds added, NF added to events, new events added, new allergies coded, generated narrative.; Sender's Comments: This case concerns a male patient of unknown age who missed second dose due other adverse events experienced post first dose of mRNA-1273. The other events show temporal association with the use of mRNA-1273 and a causal relationship cannot be excluded. However, the patient has concurrent history that confounds the reported events to include chronic pancreatitis, COPD, kidney and heart disorder. Missed dose is assessed as not applicable
66 2021-06-01 loss of personal independence in daily activities He had numbness in face and lips that started 15-20 minutes after the vaccine. The altered facial se... Read more
He had numbness in face and lips that started 15-20 minutes after the vaccine. The altered facial sensation lasted for the remainder of the same day. Altered sensation was bilateral and described as his tongue and lips felt heavy and swollen. Did not see any swelling, however. Had difficulty talking, eating and drinking and compared it to having the face numb after having dental work done. This altered sensation resolved by the next day and pt. reports back to 100% of normal. He has always had tinnitus but states his ears have been ringing a lot more since his first Covid vaccine.
66 2021-06-03 anxiety AFib; I cant walk; Heart cant send blood to rest of my body; This is ruining my life; This spontaneo... Read more
AFib; I cant walk; Heart cant send blood to rest of my body; This is ruining my life; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFib) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ATRIAL FIBRILLATION (AFib) (seriousness criteria hospitalization and medically significant). 17-Feb-2021, the patient experienced POOR PERIPHERAL CIRCULATION (Heart cant send blood to rest of my body) and ANXIETY (This is ruining my life). On an unknown date, the patient experienced GAIT DISTURBANCE (I cant walk). The patient was treated with DIGOXIN at an unspecified dose and frequency and ACHILLEA MILLEFOLIUM, CRATAEGUS MONOGYNA, OLEA EUROPAEA, VALERIANA OFFICINALIS, VISCUM ALBUM (BP (BLOOD PRESSURE)) at an unspecified dose and frequency. On 17-Feb-2021 at 12:00 PM, ATRIAL FIBRILLATION (AFib) had not resolved. At the time of the report, POOR PERIPHERAL CIRCULATION (Heart cant send blood to rest of my body), ANXIETY (This is ruining my life) and GAIT DISTURBANCE (I cant walk) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.; 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 2021-06-09 disorientation Severe Headache and disorientation. It is periodic. Events last about three days then reoccur five... Read more
Severe Headache and disorientation. It is periodic. Events last about three days then reoccur five days later lasting two to three days. This cycle persists to the present.
66 2021-06-10 disturbance in attention 3/26 temp started of over 100F x3 days, severe ache in every joint, hard to concentrate or remember;... Read more
3/26 temp started of over 100F x3 days, severe ache in every joint, hard to concentrate or remember; on 3/28, started rash all over body so called MD, they did COVID-19 test which was negative; that afternoon, rash went up neck and side of face -went to Urgent Care, had elevated pulse (120 bpm) so did EKG and other tests, got IVs hooked up and provider thought he was having a heart attack so transferred from clinic to ER -received steroids and rash went away almost immediately, determined was not a heart attack, believed instead a side effect from COVID-19 vaccination. lingering effects of fatigue, shortness of breath, ears ringing. now has new diagnosis of asthma and on inhaler.
66 2021-06-14 insomnia, poor quality sleep Stiffness all over; Couldn't sleep; Treated as though he has Polymyalgia Rheumatica; Lost weight; Bo... Read more
Stiffness all over; Couldn't sleep; Treated as though he has Polymyalgia Rheumatica; Lost weight; Body was pulsating; Muscle ache; Injection site itchy; pain radiating down pelvis, legs, thighs, feet, toes; Systemic body inflammation/bad case of inflammation; Immune system compromised; Poor sleep; Chest congestion; Bone weakness; Loss dexterity in fingers cannot attach garden hose; Pressure heart pain after walking; Muscle stiffness/stiffness all over/Consumer couldn't sleep, was waking up stiff; Muscle weakness; Pain at injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of POLYMYALGIA RHEUMATICA (Treated as though he has Polymyalgia Rheumatica) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Broken ankle in 2017. Concurrent medical conditions included Neck pain since 2018, Shoulder pain since 2018, Chronic arthritis and Diabetes. 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 20-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 27-Feb-2021, the patient experienced IMMUNE SYSTEM DISORDER (Immune system compromised), POOR QUALITY SLEEP (Poor sleep), CHEST DISCOMFORT (Chest congestion), BONE DENSITY DECREASED (Bone weakness), FINE MOTOR SKILL DYSFUNCTION (Loss dexterity in fingers cannot attach garden hose), CARDIAC DISCOMFORT (Pressure heart pain after walking), MUSCULOSKELETAL STIFFNESS (Muscle stiffness/stiffness all over/Consumer couldn't sleep, was waking up stiff), MUSCULAR WEAKNESS (Muscle weakness), PAIN IN EXTREMITY (pain radiating down pelvis, legs, thighs, feet, toes), INFLAMMATION (Systemic body inflammation/bad case of inflammation), MYALGIA (Muscle ache) and VACCINATION SITE PRURITUS (Injection site itchy). On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Treated as though he has Polymyalgia Rheumatica) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Stiffness all over), INSOMNIA (Couldn't sleep) and PALPITATIONS (Body was pulsating). The patient was treated with MELOXICAM at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form and Physical therapy for Polymyalgia rheumatica. At the time of the report, POLYMYALGIA RHEUMATICA (Treated as though he has Polymyalgia Rheumatica), IMMUNE SYSTEM DISORDER (Immune system compromised), MUSCULOSKELETAL STIFFNESS (Stiffness all over), INSOMNIA (Couldn't sleep), POOR QUALITY SLEEP (Poor sleep), CHEST DISCOMFORT (Chest congestion), BONE DENSITY DECREASED (Bone weakness), FINE MOTOR SKILL DYSFUNCTION (Loss dexterity in fingers cannot attach garden hose), CARDIAC DISCOMFORT (Pressure heart pain after walking), MUSCULOSKELETAL STIFFNESS (Muscle stiffness/stiffness all over/Consumer couldn't sleep, was waking up stiff), MUSCULAR WEAKNESS (Muscle weakness), PAIN IN EXTREMITY (pain radiating down pelvis, legs, thighs, feet, toes), INFLAMMATION (Systemic body inflammation/bad case of inflammation), PALPITATIONS (Body was pulsating), MYALGIA (Muscle ache), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE PRURITUS (Injection site itchy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, C-reactive protein: 17.2 (abnormal) Polymyalgia Rheumatica.. Treatment included non-specific "steroids." A 66 Y/O M developed serious unexpected polymyalgia rheumatica, and NS immune system disorder, musculoskeletal stiffness, insomnia, poor quality sleep, chest discomfort, bone density decreased, fine motor skill dysfunction, cardiac discomfort, muscular weakness, pain in extremity, inflammation, palpitations and other expected events. 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. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: The follow up document was added and Treatment medications, lab data, events were updated.; Sender's Comments: A 66 Y/O M developed serious unexpected polymyalgia rheumatica, and NS immune system disorder, musculoskeletal stiffness, insomnia, poor quality sleep, chest discomfort, bone density decreased, fine motor skill dysfunction, cardiac discomfort, muscular weakness, pain in extremity, inflammation, palpitations and other expected events. 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.
66 2021-06-22 feeling abnormal Sore arm; Dry cough; Mind fog; Feeling weak; Tired; Low grade fever; Headache; Lung infection; Covid... Read more
Sore arm; Dry cough; Mind fog; Feeling weak; Tired; Low grade fever; Headache; Lung infection; Covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Lung infection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Smoker. 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. In May 2021, the patient experienced PNEUMONIA (Lung infection) (seriousness criterion medically significant) and COVID-19 (Covid-19 positive). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), COUGH (Dry cough), FEELING ABNORMAL (Mind fog), ASTHENIA (Feeling weak), FATIGUE (Tired), PYREXIA (Low grade fever) and HEADACHE (Headache). On 01-Jun-2021, COVID-19 (Covid-19 positive) had resolved. At the time of the report, PNEUMONIA (Lung infection), PAIN IN EXTREMITY (Sore arm), COUGH (Dry cough), FEELING ABNORMAL (Mind fog), ASTHENIA (Feeling weak), FATIGUE (Tired), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, SARS-CoV-2 test: positive (Positive) positive. On 01-Jun-2021, SARS-CoV-2 test: negative (Negative) negative. No concomitant medication reported. The patient experienced a sore arm and feeling weak and tired. The patient experienced low grade fever, dry cough, mind fog, and headaches for 2-3 days. The patient developed a lung infection and had to be placed on antibiotics. 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. Headache fatigue and pyrexia are consistent with the product known safety profile. Based on biological implausibility, Covid-19 and pneumonia are assessed as not related to product use; 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. Headache fatigue and pyrexia are consistent with the product known safety profile. Based on biological implausibility, Covid-19 and pneumonia are assessed as not related to product use
66 2021-06-22 sensation of foreign body much more frequent AFib episodes than prior to vaccine, frequent racing heart, heaviness in the ches... Read more
much more frequent AFib episodes than prior to vaccine, frequent racing heart, heaviness in the chest, feeling of a lump in the throat
66 2021-06-29 feeling abnormal High fever, no energy. Felt as bad or worse than when I had Covid-19. Took generic Advil, fever came... Read more
High fever, no energy. Felt as bad or worse than when I had Covid-19. Took generic Advil, fever came down quickly, still felt pretty awful the rest of the day. Stated feeling better by the next day. Took me 3 or 4days to feel "normal" again.
66 2021-07-26 thinking abnormal, feeling abnormal, incoherent Scatter brain; Incoherent; Brain fog; Lost his mind; Has no reflexes; Can't move but he can hear; He... Read more
Scatter brain; Incoherent; Brain fog; Lost his mind; Has no reflexes; Can't move but he can hear; He can't talk; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Lost his mind), FEELING ABNORMAL (Scatter brain), INCOHERENT (Incoherent) and FEELING ABNORMAL (Brain fog) in a 66-year-old male 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 25-Mar-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 25-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THINKING ABNORMAL (Lost his mind) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING ABNORMAL (Scatter brain) (seriousness criterion hospitalization), INCOHERENT (Incoherent) (seriousness criterion hospitalization), FEELING ABNORMAL (Brain fog) (seriousness criterion hospitalization), AREFLEXIA (Has no reflexes), MOVEMENT DISORDER (Can't move but he can hear) and SPEECH DISORDER (He can't talk). At the time of the report, THINKING ABNORMAL (Lost his mind), FEELING ABNORMAL (Scatter brain), INCOHERENT (Incoherent), FEELING ABNORMAL (Brain fog), AREFLEXIA (Has no reflexes), MOVEMENT DISORDER (Can't move but he can hear) and SPEECH DISORDER (He can't talk) outcome was unknown. Concomitant medications were not provided. Treatment information was not provided. Reporter stated that the patient had been admitted to a total of 3 psychiatric hospitals and was currently there in the hospital. Reporter also stated that on 21-Apr-2021 the patient was acting normal for a total of 20 hours and then he started back acting weird. Company Comment: Very limited information regarding this events has been provided at this time. .Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested This case was linked to US-MODERNATX, INC.-MOD-2021-089085, US-MODERNATX, INC.-MOD-2021-111101 (E2B Linked Report).; Sender's Comments: Very limited information regarding this events has been provided at this time. .Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested US-MODERNATX, INC.-MOD-2021-089085:MOD-2021-089085 Dose 1 case US-MODERNATX, INC.-MOD-2021-111101:cross link
67 2021-01-02 impaired work ability I became very fatigued , no energy for daily tasks. I developed a non productive cough, moderate he... Read more
I became very fatigued , no energy for daily tasks. I developed a non productive cough, moderate headache, and low grade fever. now my nose is congested. I feel alittle stronger 18 hrs. later. But I called in sick tonight to work nights as a night RN, on a COVID unit. I have been working with COVID Patients after getting the first of two Moderna vaccines.
67 2021-01-06 disorientation Dizziness, Headache, Bilat LE edema, runny nose, periods of disorientation w/in 24 hours Narrative:
67 2021-01-11 sleep disorder fever to 101, chills, aches, fatigue and headache from 11:30 PM until 4 AM and the able to sleep. F... Read more
fever to 101, chills, aches, fatigue and headache from 11:30 PM until 4 AM and the able to sleep. Feeling reasonably well until 11 PM on 01/07 and the fever to 100.8 and chills and aches. By 8 AM felt ok. No further fever, chills or other symptoms.
67 2021-01-14 feeling abnormal Patient reported a fever of 102.8 around 3 am after receiving the vaccine yesterday. Feeling overal... Read more
Patient reported a fever of 102.8 around 3 am after receiving the vaccine yesterday. Feeling overall badly.
67 2021-01-21 disorientation Patient was in waiting area after vaccination and after a few minutes it was noted that his head had... Read more
Patient was in waiting area after vaccination and after a few minutes it was noted that his head had hyperextended and his eyes rolled. Laid on floor as he was unresponsive. Mask removed and gurgling noise and saliva noticed in his airway. Vitals assessed and it was detected in both his carotid and radial arteries that there was not pulse. CPR initiated. After only two compressions patient opened his eyes and started breathing on his own. He was awake, not oriented with a weak pulse. Patient provided juice sitting up in case this was diabetic reaction. EMS arrived. They did an EKG. Patient denied being transported to ER. Patient was released to care of wife at 12:30 who was instructed to bring him to ER if any symptoms reappeared.
67 2021-01-21 feeling abnormal, confusional state Immediately started getting rapid heart beat, difficulty breathing, dizziness. Half an hour later g... Read more
Immediately started getting rapid heart beat, difficulty breathing, dizziness. Half an hour later got chest pain, mental confusion and slurring of speech. Had to sit for over 30 minutes. Is allergic to Epinephrine so not able to give Epi Pen. Just had observation. It lasted a little over an hour, but was still dizzy. On 1/21/21 felt horrible, felt like he was getting sick, but has now recovered fully from the event.
67 2021-01-26 anxiety vasovagal response shortly after sitting down in observation area. pt was placed safely on floor, f... Read more
vasovagal response shortly after sitting down in observation area. pt was placed safely on floor, feet raised and regained alertness. 911 was called, vitals including Blood pressure, heart rate and alertness and orientation were monitored every 2 mins. pt was improved shortly after feet raised. the patient later returned to the pharmacy ( 2 hours later) saying he is fine, and was told his anxiety caused the event. pt did not go to the hospital.
67 2021-02-08 anxiety Client anxious about receiving first dose. Said he checked with his doctor as he has multiple antibi... Read more
Client anxious about receiving first dose. Said he checked with his doctor as he has multiple antibiotic allergies. His doctor told him to get a COVID vaccine. He received the vaccine and was asked to wait 30 minutes. After a 15 minute wait, he stated he felt chest tightness, swelling in his eyes, face and neck. His blood pressure was elevated at 180/100 and his heart rate was 150. He felt hot/cold and felt he was going to pass out. Cool cloth to forehead and comfort position. after 5 minutes his blood pressure back to 140/80 and pulse down to 100. He continued to state his face/neck and chest were swelling and felt tight. He continued to talk without lack of oxygen. He asked an ambulance be called. He was taken to a local hospital for evaluation and was released home. No medications were given and no face/neck swelling were noted by healthcare workers. Family states he is home and doing well.
67 2021-02-08 confusional state Resident woke up flushed appearing, he had the chills, pale looking. His gait was unsteady, lethargi... Read more
Resident woke up flushed appearing, he had the chills, pale looking. His gait was unsteady, lethargic, confusion, and complaints of shortness of breath.
67 2021-02-08 insomnia Headache for 4 days, full body rash on day 2, reoccuring on day 4 but not as bad, little or no sleep... Read more
Headache for 4 days, full body rash on day 2, reoccuring on day 4 but not as bad, little or no sleep for 3-4 days
67 2021-02-09 sleep disorder, loss of personal independence in daily activities 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. I have no appetite. I have spoke to my doctor on the phone Monday evening 02/08/2021, doctor said to drink fluids and take ibuprofen and it will probably go away.
67 2021-02-09 sleep disorder The original soreness seemed normal and it lasted through Saturday and Friday. Sunday it was feeling... Read more
The original soreness seemed normal and it lasted through Saturday and Friday. Sunday it was feeling better so I shoveled snow and exercised and it Monday and Tuesday and it felt like frozen shoulder. So I rested it and it was still hurting pretty bad, so I started doing exercises for frozen shoulder. Its hard to comfortable lying down and sleeping.
67 2021-02-11 excessive sleepiness Fever 100 Chills Sleep excessive Nausia
67 2021-02-11 nervousness Patient vaccinated on 1/12/21 at 10:19 and returned to vaccination clinic at 11:55. Appeared short ... Read more
Patient vaccinated on 1/12/21 at 10:19 and returned to vaccination clinic at 11:55. Appeared short of breath when walking in with respiration rate 24-26. Staff reported he presented with same appearance with first arrival prior to vaccination. Patient stated "I just don't feel good and I'm shaky". He was asked to be seated and within 5 minutes respiratory rate decreased to 20-22. Vital signs taken RR-22, B/P-110/80, HR-70 and regular, Temp-97.1. Pt states his primary care provider office is closed today. I instructed him to go to our Emergency Room for evaluation which he refused stating "I hate hospitals". After 30 minutes of observation patient stated "I'm leaving and going to see my sister who is a nurse". Treatment in our ED offered multiple times with refusal. Patient appeared stable when leaving.
67 2021-02-12 insomnia I had a severe reaction which put me in bed for three days. Symptoms included: fever, chills, aches... Read more
I had a severe reaction which put me in bed for three days. Symptoms included: fever, chills, aches, severe headache, nausea, loss of appetite dehydration due to inadequate fluid intake. And insomnia due to fever and pain. I receive a influenza vaccine each year and hardly notice any consequences. The symptoms I had in response to the Covid-19 vaccine were much worse than when I have had the seasonal flu.
67 2021-02-14 loss of personal independence in daily activities Rash at shot site and forehead , dizzy for 3 days now, bed ridden for 3 days heart rate 40 to 70, ... Read more
Rash at shot site and forehead , dizzy for 3 days now, bed ridden for 3 days heart rate 40 to 70, could not eat for two days.
67 2021-02-15 sleep disorder Woke up at 3:30 AM with Chills and fever of 99.9 had body aches took tylenol and when I woke up at ... Read more
Woke up at 3:30 AM with Chills and fever of 99.9 had body aches took tylenol and when I woke up at 6:15 felt better no fever since
67 2021-02-15 sleep disorder Cold - Chills - 48 hours No sleep - 48 hours No strength - 48 hours No Appetite - 48 hours
67 2021-02-19 sleep disorder, confusional state I woke up at 5 am (2/20/20) w/my head spinning, in a sweat, my eyes unable to focus. Felt very nau... Read more
I woke up at 5 am (2/20/20) w/my head spinning, in a sweat, my eyes unable to focus. Felt very nauseas w/bad case of vertigo. I got to the bath threw up & kept dry heaving. Sitting on the floor, I phoned Hospital, and spoke with an ER nurse. I reported my vaccine, my symptoms and told her I could not drive the 1 mile to the ER. She indicated these may be some of the serious side effects of the Moderna Vaccine. At 6am I crawled back to my bed & woke at 9:30 am. I called store & spoke to the pharmacist who vaccinated me. He concurs w/the ER nurse. I am still very weak, still slightly dizzy, and very concerned. I am a healthy 67 year old, lives by himself & this episode frightened me.
67 2021-02-21 confusional state HYPERGLYCEMIA INTO THE 500S WITH CONFUSION, WENT TO THE ED FOR EVALUATION AND RECEIVED INSULIN TO HE... Read more
HYPERGLYCEMIA INTO THE 500S WITH CONFUSION, WENT TO THE ED FOR EVALUATION AND RECEIVED INSULIN TO HELP BRING IT DOWN SAFELY.
67 2021-02-21 feeling abnormal About ten days after the first dose I began to have "brain fog". When I arrived at the donor center ... Read more
About ten days after the first dose I began to have "brain fog". When I arrived at the donor center to give a monthly platelet donation my blood pressure was extremely high, 184/104. My average blood pressure varies with an average of 135/80. Never above 150/90. It has stayed relatively high, though a late-day glass of red wine seems to bring the blood pressure lower.
67 2021-02-24 insomnia Received Moderna Covid-19 vaccine EUA 2nd dose @ 13:30 on 2/24/2021. Began experiencing steady pain... Read more
Received Moderna Covid-19 vaccine EUA 2nd dose @ 13:30 on 2/24/2021. Began experiencing steady pain and stiffness in left shoulder injection site within an hour of injection and continued throughout rest of day, night and next day (2/25/21). Began feeling run down and sore in back, neck and right shoulder at bed time (12:30 AM 2/25/21). Had difficulty sleeping all night due to musculoskeletal pain, perhaps aggravated by pre-existing anxiety (which I took 50 MG of Sertraline for during the night). Very lethargic when woke up on morning of 2/25/21 and had slight fever. Laid in bed for 2-3 hours after woke up; did not get up until 12:30 PM due to no energy. Not nauseated, but have no appetite.
67 2021-02-24 sleep disorder One week post injection, on February 18, I developed chills and a fever starting around 9 PM. I exp... Read more
One week post injection, on February 18, I developed chills and a fever starting around 9 PM. I experienced diarrhea starting around 10 PM. Fever was approx 100.4 F and was accompanied by a splitting headache and significant body aches, to the point where I was unable to get any sleep that night. I noticed Covid arm the next morning. Fever, headache and body aches continued until Monday morning. I took only Extra Strength Tylenol. Most of the time Tylenol was effective only for the first 2-3 hrs before the discomfort overcame it. I was tested twice for COVID, both Friday AM and Monday AM. Both came back negative. Starting Monday the body aches and fever began to subside but I was left with a feeling of exhaustion and required continuous sleep. Today is the first day I feel back to normal. I still have a large Covid arm rash, two weeks post injection. It causes no discomfort whatsoever.
67 2021-02-26 disorientation Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Addi... Read more
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Additional Details: Patient was sitting in observation and his head and eyes rolled back. He was observed to go into a shock state, possibly seizure for a few minutes. After a few minutes, patient regain orientation and was alert and was able to answer questions before the ambulance arrived. Patient left with the ambulance to the emergency room.
67 2021-02-26 sleep disorder Late in the evening on the date of my second shot, I experienced cold chills and unsound sleep overn... Read more
Late in the evening on the date of my second shot, I experienced cold chills and unsound sleep overnight. No adverse issues the day after the second shot..
67 2021-02-28 memory impairment Patient presents to the clinic for evaluation of itchy eyes and bilateral eyes swelling that starte... Read more
Patient presents to the clinic for evaluation of itchy eyes and bilateral eyes swelling that started on saturday after getting the vaccine. Also, states that his left arm was very painful over the weekend. He did not take any medications for it. Pt does not report any other s/s like fever, headaches, fatigue, no chest pain, no SOB, no rash. Denies any other systemic s/s of allergic reaction. No blurry vision or eye pain. Pt is a very poor historian and forgetful. Pt states that he forgot to let providers and medical staff that he had had a Pfizer vaccine at clinic on feb 15th, states that "he did not remember" and forgot to write it on the fomulary or communicate w/ provider. Pt did not bring vaccination record at the day of vaccine until today. Patient thought he could get second vaccine any time. Patient reports feeling well. No side effects. Tx given: loratadine 10 mg daily x 30 days, zaditor eye drops, short term prednisone 10 mg daily x 5 days.
67 2021-03-03 feeling abnormal, sleep disorder 3 hours after shot could feel every cell in my body, had to sleep for 2 hours, woke up with the b... Read more
3 hours after shot could feel every cell in my body, had to sleep for 2 hours, woke up with the beginning o allergic reaction of hives. I routinely get hives but this was different. Normally one dose of hive medicine 5mg will stop the itching instead I had to take a double dose and then another double dose four hours later. The next day I was still having itching issues and had to repeat the same large soes of hive medicine. Brought it under control. Felt bad for an additional two days .
67 2021-03-04 feeling abnormal Brain Fog like after waking from Anesthesia. lasted several hours. was gone by about 1:30 PM Feb 27 ... Read more
Brain Fog like after waking from Anesthesia. lasted several hours. was gone by about 1:30 PM Feb 27 2021. checked oxygen level it was 95% like usual. other Side effects were usual Headache, Joint Pain, Chills, Fever of 100.7 degrees, stomach cramps.
67 2021-03-05 confusional state He had blurred vision for a period of time. Extremely high aggression, a little delusional and confu... Read more
He had blurred vision for a period of time. Extremely high aggression, a little delusional and confused.
67 2021-03-05 sleep disorder The morning after first vaccination I noticed tightness and inflammation in the lymph nodes in my... Read more
The morning after first vaccination I noticed tightness and inflammation in the lymph nodes in my underarm area. Days later muscle inflammation throughout my arm progressively worst accompanied by occasional tingling in the fingers, After the second week I had a virtual office visit with my PPC doctor who said this was a common side effect and so I just let it take its course. After my second shot (2/15/) the same feelings have occurred but even more acute. Keeping me awake at night etc.
67 2021-03-07 feeling abnormal Chills, fatigue, gait instability, weakness Narrative: Patient reported to ED 3 days after COVID mod... Read more
Chills, fatigue, gait instability, weakness Narrative: Patient reported to ED 3 days after COVID moderna shot #1 with symptoms of unsteady gait fogginess, shuffling of feet, weakness, feeling like a "hangover" which started 2 days after shot. Did develop known infusion related reactions (fever/chills/myalgias) within 24 hours of shot. ED neurologic exam was WNL though patient left ED before a "formal" Neurology evaluation was completed.
67 2021-03-07 feeling abnormal None stated.
67 2021-03-09 fear Headache, chills, slight fever 99.5, shivering, upset stomach, thirsty
67 2021-03-09 excessive sleepiness, mental status changes, disorientation Two hours after receiving the vaccine on 3/4/21, he started feeling very tired and had a 100.2 temp.... Read more
Two hours after receiving the vaccine on 3/4/21, he started feeling very tired and had a 100.2 temp. By evening he was feeling very cold and not eating much. On 3/5/21 he was sleeping alot, had headache, chills and fever, no appetite, diaphoretic. At 8pm he could not get up out of his chair and was disoriented. Wife call an ambulance. He was admitted for altered mental status. Blood cultures showed streptococcus pneumoniae. He was hypoxic at 89%. BP 171/96, pulse 85, temp 37.3C. Chest xray showed bilteral infiltrates and a masslike density in the right lung apex. Encephalopathy, pneumonia and sepsis diagnosed. Ct of head normal.WBC count 19 and amonia 24. Wife told me he had a spinal tap on 3/9/21 and that it showed bacterial meningitis. I do not have the lab reports on that yet. THe infection control doctor told wife he is critical.
67 2021-03-10 impaired work ability Our patient describes a "normal" vaccine experience for the first couple of days following being vac... Read more
Our patient describes a "normal" vaccine experience for the first couple of days following being vaccinated. He described being really tired the day after, and felt better on day 2. The third day to the 10 day he reports he suffered with headaches, body aches, and shoulder pain, It was severe enough he missed work. On day 11 he reported feeling much better.
67 2021-03-12 excessive sleepiness Very tired, chilled, ached all over, vomited twice (This did not occur with first vax), loss of appe... Read more
Very tired, chilled, ached all over, vomited twice (This did not occur with first vax), loss of appetite, slept most of the time.
67 2021-03-12 loss of personal independence in daily activities started feeling sluggish late evening of the day of the vaccine shot. Friday, the day after the seco... Read more
started feeling sluggish late evening of the day of the vaccine shot. Friday, the day after the second shot I had no energy and just felt very ill and remained in bed all day and all night. Felt much better 24 hours later, Saturday morning.
67 2021-03-15 disorientation Very mild dizziness until morning of March12. I woke up at 02:00 AM in sweat and when I tried to wal... Read more
Very mild dizziness until morning of March12. I woke up at 02:00 AM in sweat and when I tried to walk the vertigo was so bad I couldn't walk. was disoriented and very nauseous. Was not improving and was taken by ambulance to ER. Given medication IV and orally, slowly improved enough to go home by 11:00 AM. Still dizzy on March 16th and occasional bouts of vertigo. I seem to be slowly omproving.
67 2021-03-15 feeling abnormal Information here obtained from daughter: on Thursday patient had an uneventful fistulagram with angi... Read more
Information here obtained from daughter: on Thursday patient had an uneventful fistulagram with angioplasty. Patient got vaccine at end of usual Friday am dialysis treatment. He was observed for about 30" and no untoward event noted, vitals usual. At home on Saturday morning, seemed not quite himself by wife as reported by daughter, from whom i got his information. He gets up late as hemodialysis starts at 515 am. No reported problems on Friday. On Saturday morning, he seemed not himself but sat down and ate breakfast around 9 am. On getting up from table he got suddenly weak, his head rolled back and his eyes rolled up. 911 called and he was given resuscitation efforts of unknown duration which were unsuccessful. He was pronounced dead at 11 am and the mortuary was called. No premortem labs, et al.
67 2021-03-16 confusional state, loss of personal independence in daily activities Fever over 102.1 for72 hours Extreme muscle pain and weakness over entire body Chills and confusion ... Read more
Fever over 102.1 for72 hours Extreme muscle pain and weakness over entire body Chills and confusion Bedridden for 48 hours
67 2021-03-16 confusional state Fever over 103 continuing at present Extreme muscle pain and weakness over entire body Chills and co... Read more
Fever over 103 continuing at present Extreme muscle pain and weakness over entire body Chills and confusion Bedridden
67 2021-03-17 insomnia arm pain, left arm very weak, difficulty standing up (legs weak), difficulty walking (balance), head... Read more
arm pain, left arm very weak, difficulty standing up (legs weak), difficulty walking (balance), headache, fever, chills, no sleep, left side of body warm/hot, right side cold/normal
67 2021-03-18 hallucination, amnesia The night of the second dose the wife reports that he experienced hallucinations, amnesia and incont... Read more
The night of the second dose the wife reports that he experienced hallucinations, amnesia and incontinence. According to the wife, an ambulance was called and he was taken to the hospital.
67 2021-03-20 sleep disorder Strong pain at the injection place. Fever. One sleepless night. Subsided in a day and a half.
67 2021-03-21 loss of personal independence in daily activities, anxiety, confusional state, disturbance in attention, feeling abnormal No immediate adverse reaction. No fever. Day 2 post vaccination fatigue, blurred vision, confusion, ... Read more
No immediate adverse reaction. No fever. Day 2 post vaccination fatigue, blurred vision, confusion, weakness, lethargy, inability to concentrate, loss of balance, anxiety feeling weird. Symptoms would come- had to lay down-last ~2 hours-feel okay. Again, same symptoms would start; 4-5 times a day every day. By day 7 post vaccination symptoms were severe; activities of daily living severely compromised. Blood pressure elevated 180's/100's (no history of hypertension). Emergency room visit was unremarkable. Next morning, 03/15/2021, EMS called to home. Blood pressure 217/112 finger stick 178 (no history diabetes). Transported to ER. B/P remained elevated. Cardiac negative. Head CT negative. Medications given in ER: Labatelol 10mg IV. Monitored and released to home. Diagnosis: Hypertensive Encephalapathy with TIA's. New onset hypertension. Meds: Lisinopril 10 mg daily. Seen by primary care on 03/17/2021. Elevated blood pressure continued 150/100's.
67 2021-03-22 feeling abnormal When I got home around 5:30pm on Saturday I had a 5 minute coughing fit (dry cough) which seemed to ... Read more
When I got home around 5:30pm on Saturday I had a 5 minute coughing fit (dry cough) which seemed to come out of nowhere. I was fine for the rest of the evening and when I woke up Sunday morning my arm was sore (from the shot) but I had no other side affects other than coughing occasionally. I noticed my throat was raw. I ran 3 miles, did my stretches and carried out my day without any apparent side effects. I slept poorly but that is not that unusual, doing a full exercise routine Monday morning. Other than the cough and raw throat, I seemed fine until the late afternoon (48 hour after the vaccination) when I started to ache all over--including a mild headache (which I rarely get) with the cough continuing and my throat raw. I went to be early last night in the hopes that it would be over by morning, but it wasn't. I still ache all over, including the headache, am still coughing a bit, my throat is still raw, and I feel completely dragged out.
67 2021-03-24 sleep disorder pt states when he was getting the vaccine he hurt something pop when they were putting the shot. H... Read more
pt states when he was getting the vaccine he hurt something pop when they were putting the shot. He feels as if they went too deep in the arm and it may have went through the muscle or got into a vein. Within a few hours his left arm became incredibly painful. One of the worst pain he has ever experienced and almost called the ambulance. His pain was so intense he went to bed but was unable to sleep or get out of his bed for about 24 hours. On 3/25/2021 pt is still in a lot of pain but it is getting some better.
67 2021-03-25 impaired work ability Patient describes symptoms starting the morning after receiving the vaccine of massive headache, bod... Read more
Patient describes symptoms starting the morning after receiving the vaccine of massive headache, body aches, joint aches, feeling hot and cold, jittery, and congestion. He states that they have been increasing in intensity since they have started. He reports that he is unable to work because of the symptoms.
67 2021-03-26 sleep disorder Extreme Fatigue. Body aches. Intense painful stabbing pains constantly in various lymph node locatio... Read more
Extreme Fatigue. Body aches. Intense painful stabbing pains constantly in various lymph node locations.(like armpits)Headache. Chills. Lasted about 30 hours. Stabbing pains were so bad it woke me from sleep constantly. Interestingly I did not have the red rash I had after the first vaccine and I had no adverse affects at all after the first vaccine.
67 2021-03-27 insomnia Continual ringing in the right ear. Does not stop. Unable to eat or sleep
67 2021-03-29 feeling abnormal I was very tired the night of 2nd vaccine, aside from that absolutely no side effects, hardly any ar... Read more
I was very tired the night of 2nd vaccine, aside from that absolutely no side effects, hardly any arm pain, so all well. I actually felt great for about 9 days. Then on 3/22/21 I was suddenly awaken by an intense, and peculiar, bout of vertigo. I am familiar with vertigo from ear infections in the past (last one about 15 years ago and the one prior about 22 years ago). For me vertigo is a generally mild sensation that stays with me until it clears up. This was, and is, much different, it ebbs and increases during the day, if I concentrate on a physical task it sort of diminishes, then comes back, at times it goes away completely for an hour or two then comes back strong. At same time that this started my thoughts and mental acuity started to suffer kind of a "brain fog" is the best explanation I can give. I also have a slight headache at the back of my head wrapping around to the temples, I don't know if I can link the headache to the brain fog since my neck often gives me trouble. I have ruled out ear infection by purposefully spinning myself around to see if I would lose balance, did not affect my balance. I can also walk a relatively straight line of about 20' with my eyes closed without stumbling. It feels like a kind of vertigo, but much different than any I have experienced in past and much longer lasting.
67 2021-03-30 amnesia, impaired work ability 14 hours after second shot had flu-like symptoms lasting 14 hours. Stuck in bed. Wouldn't be safe to... Read more
14 hours after second shot had flu-like symptoms lasting 14 hours. Stuck in bed. Wouldn't be safe to drive; not capable of working. Symptoms were normal flu-like, but no sinus involvement. Neighbors had same lot. The male had no symptoms at all. The wife had symptoms like mine. Mild memory loss lasting up to 4 days.
67 2021-03-30 irritability, nervousness 90% loss of smell/taste next day. Also feel irritable and nervous but manageable
67 2021-03-31 sleep disorder fever (100.2F), chills, nausea, shortness of breath, tired, headache Nausea was first about 3 hours ... Read more
fever (100.2F), chills, nausea, shortness of breath, tired, headache Nausea was first about 3 hours after shot (Tuesday). Then chills and body aches about 5 hours after shot. Very little sleep that night took Tylenol before bed. In morning (Wednesday) of next day had 100.2F fever and bad headache with body aches. Nausea left during day. Temp was 99.6F just before bed time Wed night. Fever broke around 2am Thursday with night sweats. Thursday - no fever or headache or aches, but still tired and feel feverish with activity. Right arm still sore.
67 2021-03-31 sleep disorder Headache, eyes hurt, ears ringing, body aches, cold shivering and night sweats and night. Couldn?t s... Read more
Headache, eyes hurt, ears ringing, body aches, cold shivering and night sweats and night. Couldn?t sleep at all first night. Symptoms lasted four days.
67 2021-04-02 sleep disorder 4 hours after injection, my left arm from my bicep to my elbow was giving me excruciating pain (10+ ... Read more
4 hours after injection, my left arm from my bicep to my elbow was giving me excruciating pain (10+ on a scale of 1-10). Impossible to sleep despite Tylenol to try to relieve the pain. By morning, 30 March, the pain subsided to a 1 on the same scale, but my arm swelled up from my bicep all the way to my hand and today, 4 1/2 days later, it is still swollen. My primary care doctor is sending me for a sonogram on Monday or Tuesday to discern if there is any underlying damage.
67 2021-04-04 sleep disorder Fever awakened at midnight after dose, sweating on head Then 30 minutes shaking with chills Then ach... Read more
Fever awakened at midnight after dose, sweating on head Then 30 minutes shaking with chills Then aches in practically every joint in body for several hours, including awareness between each disk in spine! Toes felt like each were exploding for several hours Fatigue Ache around brain At 6:00 a. m. I took one acetaminophen 500 mg At noon on that Saturday, April 3, I took one more acetaminophen 500 mg Remained in bed all day except small meals Tired with some aches on Sunday, April 4. Interesting: during late Saturday and some on Sunday a random, joint ached suddenly fired then ceased: example right elbow, left ankle, single disk in spine. About 4:00 p.m. April 4, Easter Sunday my energy was back and I felt better and resumed a couple of activities spraying pollen off my porches, off car, and off the garage floor. Monday: awakened with slight headache, disappeared after breakfast.
67 2021-04-07 sleep disorder Was fine after the shot for the rest of the day. Woke the morning of the 7th and felt good until ar... Read more
Was fine after the shot for the rest of the day. Woke the morning of the 7th and felt good until around noon. Started having severe body aches and chilling. Never ran a fever. Became weak where i could barely walk. Body aches were worsening until i had to lie down. Went to bed around 6:30pm but tossed and turned because of body aches. Finally fell asleep around 10:30pm and woke up around 9:00 am feeling like a new man. All symptons were gone.