Johnson & Johnson

Nervous system symptom reports

Female, 60 - 75 years

Age Reported Symptoms Notes
60 2021-03-04 tremor, muscle spasms March 5,2021 at 3:30 am approximately I woke up trembling severely ( entire body ) and intense inter... Read more
March 5,2021 at 3:30 am approximately I woke up trembling severely ( entire body ) and intense internal spasms :, high fever : could not grab or hold bottle of water ; tried to get up and and could not stand trembling so bad : I covered up and it lasted till 7:30 am. Now bad headache and back ache
60 2021-03-06 nerve pain Onset approximately 12 hours p vaccination. Low grade temp. 99.4 ° (normal baseline 97.3) Chills (m... Read more
Onset approximately 12 hours p vaccination. Low grade temp. 99.4 ° (normal baseline 97.3) Chills (mild to moderate) Headache (mild to moderate) Neuralgia (mild to moderate) Tinnitus (moderate) Muscle aches (moderate) Site tenderness (mild) Cough (intermittent)
60 2021-03-07 tremor Experienced light headedness and felt shaky few minutes after receiving the vaccine. BP 142/70 O2 s... Read more
Experienced light headedness and felt shaky few minutes after receiving the vaccine. BP 142/70 O2 sat - 100%
60 2021-03-07 unresponsive to stimuli Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Fain... Read more
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Fainting / Unresponsive-Medium
60 2021-03-09 flushing pt became flush and had trouble breathing and fainted
60 2021-03-09 pain in extremity, burning sensation Severe headache, very tired, muscle aches,fever, short periods of dizziness, several hours of the fe... Read more
Severe headache, very tired, muscle aches,fever, short periods of dizziness, several hours of the feeling of pressure on my chest which then was replaced by significant burning sensation, bottoms of both feet were very painful and a wrist that i broke a couple of years ago and a knee which has caused pain in the past were very, very painful.
60 2021-03-09 seizure Patient experienced a seizure lasting 2-3 minutes approximately 1-2 minutes after receiving the vacc... Read more
Patient experienced a seizure lasting 2-3 minutes approximately 1-2 minutes after receiving the vaccine. patient has a history of seizures/epilepsy.
60 2021-03-11 weakness Weak/fatigue Nausea Headache
60 2021-03-11 pain in extremity Immediate pain after injection in arm at injection site with some pain moving up in the neck muscle... Read more
Immediate pain after injection in arm at injection site with some pain moving up in the neck muscle and lower arm. After 24 hours the pain increased and moved into shoulder and neck pain increased. No redness in injection site but muscle pain increased and continued into day three.
60 2021-03-11 cold extremities Patient is a 61 y.o. female who received the Janssen Covid vaccine Lot# 1805020 on 3/12/2021. The p... Read more
Patient is a 61 y.o. female who received the Janssen Covid vaccine Lot# 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate of observation: "Feeling funny" "Cold feet" Patient was treated/managed as follows: Vital Signs: 1240pm -BP: 140/76 HR: 94 RR:18 1250pm-BP: 133/88 HR: 82 RR: 18 Pt reports feeling better Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted out to car by Site Lead
60 2021-03-11 throat numbness Nothing serious but the roof of my mouth and back of my throat felt numb for about an hour and then ... Read more
Nothing serious but the roof of my mouth and back of my throat felt numb for about an hour and then was tingly. This happened about 30 minutes after the shot. I also was very nauseous the next morning.
60 2021-03-12 pain in extremity, night sweats, tremor Fever for 40 hours, chills, uncontrollable shaking for more than 3 hours, severe nausea for 36 hours... Read more
Fever for 40 hours, chills, uncontrollable shaking for more than 3 hours, severe nausea for 36 hours, nausea continues now but at a much less severe amount, swollen glands around head and in right arm pit for more than 40 hours, pain in right eye started within 10 minutes of shot and continues now, pain in ankles started about 8 hours after shot and continues now but is becoming much more bearable, joints of toes and joints of a few fingers were painful for about 24 hours, sore arm started about 3 hours after shot and continues now, overall muscle aches started about 8 hours after shot - became much worse within 12-14 hours after shot and became less severe after 30 hours. Overall I felt as if I had a terrible case of the flu. It was very intense. I was unable to sleep the first night due to the severity of symptoms. The second night I sweated a tremendous amount and my fever broke. I am still not over all of my symptoms but I am feeling better.
60 2021-03-12 tingling, flushing Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Genera... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient about 12-24 hours after shot started to develop a rash on arms/neck and hands. Her arms/hands started to swell and she developed blisters in the mouth and had blisters on her hands and neck as well. She had itching all over her arms and hands and swelling of the arms and hands too. She also felt a warming/hot and burning sensation in her arms and hands too. She has been putting clobetasol and hydrocortisone cream/ointment and Levicyn (compound by Dr.) on the blisters and rash.
60 2021-03-12 tension headache Arm soreness at site of injection lasting for several days. A tension headache developed by 2pm the ... Read more
Arm soreness at site of injection lasting for several days. A tension headache developed by 2pm the day of the shot. Not debilitating, but obvious. It lasted until late the first night, leaving a feeling of lightheadedness afterwards that was gone by late morning the next day. Some tiredness, but not extreme.
60 2021-03-14 feeling hot, tingling About 5pm after I began feeling achy and fatigued. The next day after I developed the tingly, pin... Read more
About 5pm after I began feeling achy and fatigued. The next day after I developed the tingly, pins and needles sensation that came and went in both legs, my face, arms and both hand area which I am still experiening today but not as frequent as it was when it began. When it happens its not always in the same spots and doesnt occurs at the same times its as if it alternates and now I also get a hot sensation at the top of my ears periodically which doesnt last very long but it does occur
60 2021-03-14 feeling hot patient had a hot feeling all over her body and her skin was red. . had no rash, no fever, no lesio... Read more
patient had a hot feeling all over her body and her skin was red. . had no rash, no fever, no lesions. this resolved on its own.
60 2021-03-15 feeling cold Felt great and then all of a sudden diarrhea started around 11 pm. Went to bed and became extremely ... Read more
Felt great and then all of a sudden diarrhea started around 11 pm. Went to bed and became extremely cold - teeth chattering, chills and fever at 11:30pm - approx. 8 1/2 hours after injection. After that vomiting, soreness, headache body aches, fever of 100 degrees. When awaking the next morning, still had fever of 99.8, chills, nausea, headache. Finally felt like myself by 3pm on Tuesday, March 16. I am not a chronic complainer. After receiving my flu shots every year for many years, this was the first reaction I've ever had to any immunization - ever.
60 2021-03-25 feeling hot, feeling cold 8 hours after the vaccination, patient felt cold/chills along with ascending body temperature. Then... Read more
8 hours after the vaccination, patient felt cold/chills along with ascending body temperature. Then, patient felt hot. Dizziness and fever persisted for almost 12 hours. Patient waking up in the morning felt lose of appetite due to nausea.
60 2021-03-28 feeling cold, cold sweat, tremor Approximately, 11 hours after the shot Severe cold chills, so severe my teeth would not stop chatter... Read more
Approximately, 11 hours after the shot Severe cold chills, so severe my teeth would not stop chattering. I was shaking so hard my body ached from shaking. Goosebumps, a crazy headache. I thought i was having an anurysm. Not a normal headache. Cold sweats so bad you could just about wring out my sheets and clothes. Nausea, some vomiting. On a scale of 1-10 of these symptoms is was an 11-12. These symptoms changed as the days went on. In the moring of the first night. I was ok. Woke up with a bad headache, still nauseas and still cold but not like at night tollerable. About 5PM day 2 it started all over again, just as severe. Next moring ok. This pattern kept reapeating for 4 days. Food now getting repulsive. No way I could eat anything. On day 5 the symptoms continue now throug the day, however the teeth chattering not happeing and the cold chills a bit less severe. I would say by day 5 on the scale of 1-10 i am now about a 9. This was so horrible for so long. Every single night i would wake up soaked in my own sweat. This is still happening 11 days later. I am still experiencing headaches. I never have headaches. I did not go to a Doctor because i figured what are they going to do, i have to ride this out. Also a strange thing is took my temparture daily and seveal times. Zero temprature. by day 5 I could not get out of bed for 3 days. Day 8 things getting better, still cold chills and headaches but not as bad. Day 9 way better, now getting hungry. Daytime cold chills now gone mostly less headaches. Oddly headaches and cold chills start about 4-5pm and continue through the night. In the morning i wake up with a headache still today.
60 2021-03-29 weakness Sensitivity started within four hours of dose. Autistic sensitivities to maximum. Scrambling of all ... Read more
Sensitivity started within four hours of dose. Autistic sensitivities to maximum. Scrambling of all senses including proprioception to the point of not being able to move from standing or sitting. By hour seven, all sensory inputs were too overwhelming to do anything but shut down and sleep. 911 was not an option because they don't let you sleep, and ERs are overwhelming already, before maximizing all inputs. 7.5 mg hydrocodone for overwhelming pain and sensitivity, allowed sleep. On waking, sensitivity was lessened, but the pain started, 18 hours after the vaccination. Emotional lability for three days. Average aching of arm and injection site were not above expected levels. "Brain fog" and lack of ability to articulate (another autism symptom) started within that first seven hours, and diminished over next ten days. Not yet gone as of today Dry mouth; overproduction of thick 'chunky' mucus that wouldn't cough out, treated with guaifenesin, lasted three days. Shortness of breath and cough associated with that mucus also diminished after three days. Not completely gone ten days later. Excessive thirst, onset two hours after vaccine, lasted two days. Hyperalert (can't sleep without drugs), hyperactive despite weakness, and hypervigilant (extreme startle reflexes) lasted three days as well. Sleep was achieved with hydrocodone and THC. All over body pain, feelings of immune mobilization (coming down with) for two days were not above expected levels. No fainting or other collapse at time of injection, or later. Knowing that severe over-stimulation is exacerbated in a medical setting, it was decided not to seek medical support for three days of systemic symptoms that would have easily merited hospitalization.
60 2021-03-30 pain in extremity RIGHT ARM SORENESS; This spontaneous report received from a patient concerned a 69 year old female. ... Read more
RIGHT ARM SORENESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes, and heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the patient experienced right arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm soreness. This report was non-serious.
60 2021-03-30 tingling I am covered in a severe rash that itches burns and tingles. First RX was a 4mg prednisone pack that... Read more
I am covered in a severe rash that itches burns and tingles. First RX was a 4mg prednisone pack that did not help from an urgent care facility. I then went to Dr who gave me RX and the next day it was worse again so the current RX is described earlier. It is not getting any worse but I am struggling to not itch. I can not wear clothes for long periods of time and it is quite debilitating Clothes
60 2021-04-01 pain in extremity Severe Psoriatic arthritis flare, red swollen, painful joints, hands and feet.
60 2021-04-05 weakness FEVER, CHILLS, HEADACHE, SHIVERING, LOW ENERGY
60 2021-04-05 feeling cold I couldn?t get warm, cold to the point of shivering for approximately 16 hours. I have fully recove... Read more
I couldn?t get warm, cold to the point of shivering for approximately 16 hours. I have fully recovered.
60 2021-04-05 feeling cold Approximately 12 hours after receiving the vaccine I experienced severe chills and couldn't get warm... Read more
Approximately 12 hours after receiving the vaccine I experienced severe chills and couldn't get warm. I didn't take my temperature. The chills lasted approximately 5-6 hours. The day after receiving the vaccine I experienced fatigue and minor muscle aches.
60 2021-04-05 feeling hot I received the Jenssen COVID-19 vaccine EUA on April 5, 2021 Around 3:30 am on April 6th, I woke up... Read more
I received the Jenssen COVID-19 vaccine EUA on April 5, 2021 Around 3:30 am on April 6th, I woke up hot and itching. I had a under the skin rash on my arms and legs with little pin prick spots my tongue was tingling. I took Benadryl. It was better in the morning but still visable and tongue was tingling. I took more Benadryl around lunch time.
60 2021-04-06 flushing generalized flushing of both arms and neck 30 mins post vaccine (similar to past reaction to PCN)
60 2021-04-06 pain in extremity SORE UNDERNEATH THE ARM; HEADACHE; EXTREMELY TIRED; This spontaneous report received from a patient ... Read more
SORE UNDERNEATH THE ARM; HEADACHE; EXTREMELY TIRED; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805029, expiry: not reported) dose was not reported, once a total administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced sore underneath the arm. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced extremely tired. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from headache, extremely tired, and sore underneath the arm. This report was non-serious.
60 2021-04-07 weakness Chills and low grade fever, then within another hour felt light-headed and my body hurt all over - s... Read more
Chills and low grade fever, then within another hour felt light-headed and my body hurt all over - skin was sensitive to even my clothes. Headache started in the front of my forehead by late evening, and I literally couldn't even walk up to my bed. Restless sleeping with all the sweating and chills. Woke up with headache remaining and feeling very "wiped out" and still light-headed. No more chills or sweats the next day, but I was weak for about 48 hours. Honestly - I'm very healthy and getting Covid directly from another person couldn't have been worse than getting the vaccine. :( And I am even saying that as a 35 year professional Research Scientist. Thank you
60 2021-04-08 weakness, feeling hot, tingling Felt hot within a few minutes after the vaccine, then passed out. The NP on site said she was unable... Read more
Felt hot within a few minutes after the vaccine, then passed out. The NP on site said she was unable to find a pulse so did 10 chest compressions before I woke up. Called the rescue squad who did an EKG on route to Hospital and once I was in the ER another EKG was performed along with blood work and chest X-ray. Entry was noted as allergic reaction but diagnosis was noted as Vasovagal Syncope, Adult. EKG?s performed along with labs were normal. I have pulled muscles, tendons and ligaments from the chest compressions which were questionable but since that day have experienced tingling in upper body and arms and have felt bad. Went back to my Primary Care Doctor for follow up on March 29 for another EKG. Have had panic attacks from the situation and per Doctor will take 2 months for my chest, muscles, tendons and ligaments to heal. Hard to determine if the way I have felt is from the vaccine or what transacted when I fainted. Today which is April 9, I still feel weak, normally I am very energetic. Just wanted to report as when I saw the news that others had some situations thought best to let you know.
60 2021-04-08 tremor A few hours after the Thursday afternoon injection, my temp shot up and stayed right around 102, my ... Read more
A few hours after the Thursday afternoon injection, my temp shot up and stayed right around 102, my heart rate was 135- just sitting, and my oxygen level was 93%. I shook uncontrollably the first 10-12 hours, and had chills. Tinnitus. Nothing inproved until the middle of Friday night- I sweated through sheets. Still had fever, high heart rate, and up and down oxygen for 18-20 days. My heart rate (I'm on 2 anti-arrhythmia drugs so my rate is rarely above 65) was still high but better by day 22. Fever is also better but not gone. Exhausted.
60 2021-04-09 weakness extreme fatigue mild headache muscle pains nausea and vomiting chills taste confusion loss of appet... Read more
extreme fatigue mild headache muscle pains nausea and vomiting chills taste confusion loss of appetite eye focus issues dizziness brain fog low grade fever sores on tongue lip blisters (Important to note: still experiencing severe blisters on my lips) low energy and fatigue continues day to day
60 2021-04-09 muscle spasms mild intermittent stomach muscle spasms the following afternoon after receiving the vaccine shot the... Read more
mild intermittent stomach muscle spasms the following afternoon after receiving the vaccine shot the night before. Same symptoms 48 hours later.
60 2021-04-09 nerve pain, feeling cold Headache, fatigue, chills, intermittent shooting nerve pain at the left angle of my mandible. I we... Read more
Headache, fatigue, chills, intermittent shooting nerve pain at the left angle of my mandible. I went to work on Tuesday because my work was short staffed but was allowed to go home 3 1/2 hours early. I took Advil every 4-6 hours on Tuesday and half of Wednesday. I came straight home and slept until dinner, ate and then went back to bed and slept until midnight, took more Advil and drank a full glass of water, and slept the rest of the night. Wednesday I felt a bit better, headache not as bad and jaw pain not as frequent, still pretty tired. I went to bed straight after dinner and then felt great on Thursday.
60 2021-04-09 nerve pain Severe joint pain (like arthritis) in all joints. It is not going away after12 days. Also, severe ne... Read more
Severe joint pain (like arthritis) in all joints. It is not going away after12 days. Also, severe nerve pain in left side of body. This has never happened to me before.
60 2021-04-09 pain in extremity Chills, Nausea, Headache, Body Ache, Skin Hurt, Left hand pain base of middle finger back of hand La... Read more
Chills, Nausea, Headache, Body Ache, Skin Hurt, Left hand pain base of middle finger back of hand Lasted about 5 hours, Headache remained into the next morning. Took Benadryl and Ibuprofen
60 2021-04-09 pain in extremity Was doing CDC TEXT tracing first week after injection, but new reactions started after tracking comp... Read more
Was doing CDC TEXT tracing first week after injection, but new reactions started after tracking completed. Had mild reactions originally. Pain in arm, and fever next day that rose to 100.9. No chills, no major problems, no rash. A couple nose bleeds on second day which were not typical for me. Returned to work on third day. Now on day 10 I'm convinced I'm having a delayed reaction. Still mild but present. Low temp 99.5, headache, fatigue, feeling of not being normal. Not allowed to work today. Reason for report of such mild symptoms is my surprise of this delayed reaction 10 days later. There is a bruise on my injection arm now, opposite side of arm, that also is puzzling, but not really worrisome. Know to monitor for platelet issues.
60 2021-04-10 weakness Woke up with body aches, headache, low grade temperature. Stayed in bed most of day(thu) That even... Read more
Woke up with body aches, headache, low grade temperature. Stayed in bed most of day(thu) That evening finally took a couple tylenol because the aching was preventing me from sleeping. Fri I felt better maybe a little tired. Friday evening I started vomiting, and had diarrhea. Fever was at 202 at highest. Brain fog. Had severe chills for a couple hours. Fever hung around 100 most of Saturday. Have slight tightness in upper chest. Occassional dry cough. Occassional diarrhea. Weak. Sunday. Still have occassional diarrhea. Temp has been around 99.5. Weak. But a little more energy. Still have tightness in chest.
60 2021-04-10 tremor Severe shaking, fever of 103.3 for 4 days, nausea, vomiting, aches, severe headache, dizziness
60 2021-04-11 weakness Day 1 40min in... intense, in-tense....fiery, pain radiates from-injection. Up neck, across shoulde... Read more
Day 1 40min in... intense, in-tense....fiery, pain radiates from-injection. Up neck, across shoulders and down back. In.tense. Fiery. Pain. Just over 1hr very intense bone ache. Not muscle. Bone. Ache. Stop for lunch and find extreme bone ache across collarbone. Intense pain. Like i thought I broke collarbone. On walking in, to order lunch, dizzy and blurred vision. Had to sit awhile to dissipate. 1.5 hrs in Finish eating and spend time breathing thru pain. Vision clear, on my way back to work. Intense pain continues adding, now, itchy across shoulders. Through afternoon increased fatigue and itch. Little better at 4hrs. Day 2 utter fatigue. Want to. S.l.e.e.p. Pain now replaces the burn. Every. Where; ache. Ache. Ache. Day3 fatigue on waking. Pain is now in all joints. Knees hips excruciating. Manage 3hrs household tasks before the fatigue sets in to stop. Awake but still pain in joints. Not ache; pain. Hard to move. Spend afternoon cooking and resting. Soooo exhausted. Day 4-2wks arm still sore and swollen and warm to touch. cannot bear weight in left arm. Cannot use arm to drive. swelling down day 15 still cannot bear weight in left arm. pain continues along pathway of injected drug. burn sensation. now day 17 still cannot bear weight in left arm. If I do I get sudden weakness in arm and pain in back of shoulder.
60 2021-04-11 bell's palsy Bell's Palsy
60 2021-04-11 numbness, tingling, pain in extremity Within first hour: pain at vaccination site, headache and left neck/shoulder ache, worser headache, ... Read more
Within first hour: pain at vaccination site, headache and left neck/shoulder ache, worser headache, numbness and tingling on left side of face and jaw (sort of like novocaine?) spreading down left arm, increasing severity of headache, nausea, tiredness. Throughout pm: chills, body aches, decreasing numbness on left side face/arm, increased fatigue. Took 2 acetamenaphen extra strength Throughout night: severe chills, headache, body and muscular pain. Day 2: frequent and severe chills; mild fever (100.8); severe headache, severe joint, muscle, and body aches (like flu), nausea, severe fatigue. Day 3(today): much fewer chills, decreased nausea, some fatigue, increased pain in back along spine and down legs, cont tylenol xs
60 2021-04-11 migraine Within 5 minutes of receiving the shot, I had stomach cramps and felt extremely nauseous. I had per... Read more
Within 5 minutes of receiving the shot, I had stomach cramps and felt extremely nauseous. I had periods of nausea and dizzy spells for the following week. I had an extreme migrane the night of the shot and chills throughout the next week. I did not report the symptoms to anyone because I had not heard that these were reactions to this vaccine. After I heard that others were experiencing similar symptoms, I felt I should report my experience.
60 2021-04-11 tremor, weakness, tenderness Extreme chills where my body would not stop shaking, sweats, muscle aches, nausea, bad headache, tir... Read more
Extreme chills where my body would not stop shaking, sweats, muscle aches, nausea, bad headache, tired. Took 2 Tylenol every 4-6 hours to help the headache. It lasted until Sunday morning. My nose felt stuffy when I woke up Sunday morning at which time there was blood in my nose. The rest of the day it was clear but a small amount appeared Monday morning as well. Both sides of my temples are sore to the touch as if they were bruised. Other than that and being weak the other symptoms are gone.
60 2021-04-11 tremor Extreme chills & shaking. Blood pressure hyper (160/90]and hypotensive (90/65), erratic pulse, feve... Read more
Extreme chills & shaking. Blood pressure hyper (160/90]and hypotensive (90/65), erratic pulse, fever (102.4), headache, nausea.
60 2021-04-12 weakness headache, left body stiffness and pain, left sided weakness (sensation of body drooping). Strong flu... Read more
headache, left body stiffness and pain, left sided weakness (sensation of body drooping). Strong flu-like symptoms
60 2021-04-12 burning sensation, feeling cold, tremor, weakness 3/22/21: Vaccine administered 4:45 pm. Burning sensation on arms and legs began about 2 hrs later. A... Read more
3/22/21: Vaccine administered 4:45 pm. Burning sensation on arms and legs began about 2 hrs later. Achy and feeling cold about 2 hrs after that. Then headache, shaking, muscles quivering, fever, weakness, some itchy spots, increased urination throughout next several hours. Fitbit showed elevated heart rate for several hours. 3/23/21: Nausea and vomiting. Could not keep water down. Very weak/shaky. That night, went to ED. Treated for dehydration and allergic reaction. 3/24/21: Able to tolerate clear liquids. Still weak. 3/26/21: Woke up with rash on both legs (small bumps, not itchy). Added bread to diet. Still weak. 3/29/21: Low grade fever, strong pain in right side of lower back.
60 2021-04-12 burning sensation The patient had burning sensations and increased urination symptoms consistent with a possible urina... Read more
The patient had burning sensations and increased urination symptoms consistent with a possible urinary tract infection prior to the vaccination that took place on 2 April 2021. A urinary culture was negative on 31 March 2021. A few days after the vaccination, the burning pain and urgency subsided but was replaced by increasing lower abdominal pressure and pain. The patient will see a doctor on 14 April 2021. Other effects observed following the vaccination on 2 April 2021 include: headaches, muscle pain, injection site arm pain, sore throat. These effects resolved within 24 hours after the vaccination with exception of the sore throat which is ongoing.
60 2021-04-12 muscle spasms, pain in extremity Severe vein pain around ankle/lower calf and knee pain, and some swelling. Severe cramping in both l... Read more
Severe vein pain around ankle/lower calf and knee pain, and some swelling. Severe cramping in both legs.
60 2021-04-12 pain in extremity 1ST DAY=Heachache, Dizzines, High blood pressure, Inflamation of hands. 2ND DAY= High blood pressure... Read more
1ST DAY=Heachache, Dizzines, High blood pressure, Inflamation of hands. 2ND DAY= High blood pressure, headache, chills 3RD Day: Headache, kidney pain 4th Day: Headache, body ache. 5th day: Heachache, leg pain, can't sleep.
60 2021-04-13 weakness Developed heart palpitations approximately 10 hours after receiving vaccine. Also insomnia making i... Read more
Developed heart palpitations approximately 10 hours after receiving vaccine. Also insomnia making it impossible to sleep. Palpitations seemed to get better by 11 am the next morning but my heart rate was still elevated ( pulse 106-112). Shortly after that ( around 11:45 am) I became extremely light headed and dizzy and felt like I was going to pass out. I also started to feel nauseous and sweaty. I rested lying down for two hours before hearing back from my doctor's office. I was able to control the lightheadedness and dizziness by lying down. The feeling of passing out / nearly fainting went away. I continued to feel nauseous and my heartrate was still elected. I started to get a headache as well. On the advise of a nurse at my doctor's office, my husband took me to the ER. My EKG was normal . My heartrate was elevated. Due to the overcrowding at the ER that day I was made to wait at least an hour and half for further evaluation. I continued to feel light headed and slightly dizzy. My nausea and headache got much worse . I was finally taken back to a treatment room and received IV fluids, Zofran and Tylenol. My heartrate went back to normal and my headache and nausea improved with treatment and I was discharged around 7pm. I continued to feel very tired and slightly lightheaded that evening. The next morning I was much more nauseous again and still very weak feeling and slightly lightheaded. I have continued to feel weak, very fatigued , unwell and nauseous on and off until today, April 14, which is 6 days after I was vaccinated.
60 2021-04-13 burning sensation, cold extremities One week after shot experienced left sided chest pain2/10 progressed to burning in left axils. Fatig... Read more
One week after shot experienced left sided chest pain2/10 progressed to burning in left axils. Fatigue heaviness in bilateral arms and legs. Cold feet. Persistent dull left temporal headache. Felt dizzy and lightheaded in addition on 4/7 went to ER
60 2021-04-13 mild one side paralysis, numbness, tingling Severe Headache; right sided weakness; confusion; blurred vision; numbness and tingling right leg.
60 2021-04-13 hot flush, feeling hot, feeling cold Started on Monday morning at 8:30 am started feeling cold chills. Took 800mg of Ibuprofen and after... Read more
Started on Monday morning at 8:30 am started feeling cold chills. Took 800mg of Ibuprofen and after an hour felt better. When going to bed around 9:00pm I noticed that my skin was soaking wet and that I had a hot feeling. When I woke up in the morning (tuesday April 13, 2021) around 7am I could not fully open my eyes. I looked in the mirror and noticed that my entire face was swollen and was red in different areas. I took some benadryl as I thought this was an allergic reaction and went back to bed. A litter later I started getting cold chills and then hot flashes. Around noon time I took another benadryl. By 2:30 I was not feeling any better and I also had body aches and pains and called my doctor. I was able to get in to the office. I was told that I was having a reaction to the shot and that I was boarder line for the hospital. They gave me a shot steriod shot and prescribed Metheylprednisolon tablets (24) to be taken as directed and to continue to take benadryl. It's now Wednesday morning April 14, 2020 and the swelling has gone down but not fully gone and I have stated on the prescription. I now have redness in my chest area. I still have a some chills and hot flashes.
60 2021-04-13 migraine My illness is constantly vomiting, dizziness, and migraine headache.
60 2021-04-13 pain in extremity FEVER; FATIGUE; ARM SORENESS; This spontaneous report received from a patient concerned a 60 year ol... Read more
FEVER; FATIGUE; ARM SORENESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of this reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: not reported) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced arm soreness. On 04-APR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness on APR-2021, and had not recovered from fever, and fatigue. This report was non-serious.
60 2021-04-13 pain in extremity SWOLLEN LEGS AND FEET; ACHES AND PAIN IN NECK; LEGS FELTS TIGHT; FEET FELTS TIGHT; ACHES AND PAIN IN... Read more
SWOLLEN LEGS AND FEET; ACHES AND PAIN IN NECK; LEGS FELTS TIGHT; FEET FELTS TIGHT; ACHES AND PAIN IN HIPS; ACHES AND PAIN IN ARMS; EXHAUSTED DAY AND NIGHT; This spontaneous report received from a patient via a company representative concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On APR-2021, the subject experienced swollen legs and feet. On APR-2021, the subject experienced aches and pains in neck. On APR-2021, the subject experienced legs feel tight. On APR-2021, the subject experienced feet feels tight. On APR-2021, the subject experienced aches and pains in hips. On APR-2021, the subject experienced aches and pains in arms. On APR-2021, the subject experienced exhausted day and night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the exhausted day and night, aches and pains in hips, swollen legs and feet, aches and pains in arms, aches and pains in neck, legs feel tight and feet feels tight was not reported. This report was non-serious.
60 2021-04-13 tenderness, pain in extremity Pt reports sharp intermittent pain in right posterior thigh on and off x 3 days, no other associated... Read more
Pt reports sharp intermittent pain in right posterior thigh on and off x 3 days, no other associated symptoms. Symptoms are improving gradually with time. Exam remarkable for mild tenderness along right distal posterior thigh medial aspect Advised on supportive care for possible muscle strain CBC and Ddimer ordered due to history of Janssen Vaccine
60 2021-04-14 discomfort Fever to 102 degree Fahrenheit from 6pm of the day of shot at 1:15pm, till 4pm next day accompanied ... Read more
Fever to 102 degree Fahrenheit from 6pm of the day of shot at 1:15pm, till 4pm next day accompanied by chill, fatigue, body heaviness, Treatment was rest. Recovered by 3rd day. Vaccination shot site of arm extreme soreness the day after the shot for 2 days
60 2021-04-14 slurring, inability to speak elevated blood pressure, slurred speech, expressive aphasia, blurred vision,headache,shortness of br... Read more
elevated blood pressure, slurred speech, expressive aphasia, blurred vision,headache,shortness of breath confusion.
60 2021-04-14 muscle spasms Johnson & Johnson vaccine -1 dose in left arm. I've been having night time leg cramping in backs of... Read more
Johnson & Johnson vaccine -1 dose in left arm. I've been having night time leg cramping in backs of both legs (calf muscles).
60 2021-04-15 facial pain ACHE MOSTLY ON THE FACE AREA; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patie... Read more
ACHE MOSTLY ON THE FACE AREA; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug use. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced ache mostly on the face area. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 5/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache mostly on the face area, chills, headache, and fever on 08-APR-2021. This report was non-serious.
60 2021-04-15 feeling jittery I felt very jittery felt as if I drank about 16 cups of coffee! Felt a little bit pressure in my hea... Read more
I felt very jittery felt as if I drank about 16 cups of coffee! Felt a little bit pressure in my heart. Could not sleep on Saturday night extreme anxiety feeling. Extreme hyper active feeling!!! Felt like if I had a surge of energy. Very restless, legs felt jittery! Left lymph node in my neck was swollen and slight headache.
60 2021-04-15 flushing 4/11/2021 @ 3:00p. S/P Administration of JNJ Janssen; the patient reported having a "flushed feeling... Read more
4/11/2021 @ 3:00p. S/P Administration of JNJ Janssen; the patient reported having a "flushed feeling" and states "I can tell that its getting into my system". BP 150/104 HR 120. Sats 100%. RR 16. Flushed lasted about 30 seconds. After 15 minutes, BP 146/105 HR 104 RR 16. Pt asked to wait additional 15 minutes (totaling 30min). During wait time, the patient was conversating with her husband. There was no signs of acute distress. RR remained within range 14-16. Following wait time, the patient denied flushed feeling and stated "feeling okay". 4/15/2021@4:45pm Pt returned to clinic and stated that she continues to have the "flushed feeling". She reports going to ER the night before for elevated BP. She had a dedicated CTA to rule PE and LE doppler for DVT. According to her. both test were "fine". She did report that her BP was around 200s. She denies hx of HTN and current meds use. She was discharged home with clonidine.
60 2021-04-15 muscle spasms, migraine BONE ACHE; BODY ACHES; VERY HIGH FEVER; CRAMPS IN CALVES/LEG CRAMPS MOSTLY INSTEP AND CALVES; MIGRA... Read more
BONE ACHE; BODY ACHES; VERY HIGH FEVER; CRAMPS IN CALVES/LEG CRAMPS MOSTLY INSTEP AND CALVES; MIGRAINE TYPE HEADACHE LIKE STEAK THROUGH THE HEAD; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid, and seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced migraine type headache like steak through the head. On 06-APR-2021, the subject experienced cramps in calves/leg cramps mostly instep and calves. On 06-APR-2021 03:00, the subject experienced bone ache. On 06-APR-2021 03:00, the subject experienced body aches. On 06-APR-2021 03:00, the subject experienced very high fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone ache, and very high fever on 06-APR-2021, and migraine type headache like steak through the head, cramps in calves/leg cramps mostly instep and calves, and body aches on 07-APR-2021. This report was non-serious.
60 2021-04-15 pain in extremity FEELING WOOZY OR DIZZINESS; HEART RACING; FEELING VERY TIRED; HEADACHE; MUSCLE ACHE; ACHY ARM; This ... Read more
FEELING WOOZY OR DIZZINESS; HEART RACING; FEELING VERY TIRED; HEADACHE; MUSCLE ACHE; ACHY ARM; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced achy arm. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced muscle ache. On 10-APR-2021, the subject experienced feeling very tired. On 11-APR-2021, the subject experienced heart racing. On 12-APR-2021, the subject experienced feeling woozy or dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy arm, and muscle ache on 11-APR-2021, and feeling very tired on 12-APR-2021, and had not recovered from heart racing, feeling woozy or dizziness, and headache. This report was non-serious.
60 2021-04-16 weakness Chills, diarrhea, lung pain, stabbing pain, headache, weakness and very tired for several days.
60 2021-04-16 feeling cold Janssen COVID-19 Vaccine EUA Chills, fever and headache for approx 40 hours. Controlled with Tyleno... Read more
Janssen COVID-19 Vaccine EUA Chills, fever and headache for approx 40 hours. Controlled with Tylenol. Fine after that.
60 2021-04-16 numbness, muscle spasms, nerve pain Immediate pain upon injection. Rapid heart beat . Sore arm at injection site. Later flu like sympt... Read more
Immediate pain upon injection. Rapid heart beat . Sore arm at injection site. Later flu like symptoms: headache, chills, slight fever, body aches Later terrible leg cramps and numbness in both legs which sent me to emergency room 4/12/2021 Continued pain in nerves in arms and legs, muscle cramping. Nerve sensitivity on left side(shot arm) of face
60 2021-04-16 pain in extremity Very strong pain on my legs at night and abdominal pain during the day
60 2021-04-17 tingling Severe weakness in arms, especially upper arms, tingling, fatigue, queasiness.
60 2021-04-18 pain in extremity Six days after receiving the Johnson & Johnson/Janssen vaccine, the patient complained about strong ... Read more
Six days after receiving the Johnson & Johnson/Janssen vaccine, the patient complained about strong pain in the right arm (same as vaccination arm). She went to the ER on the 7th day after receiving the vaccination and after doing EKG, ultrasound, and CT scan, they found multiple blood clots in her right arm where she receive the vaccine.
60 2021-04-19 weakness, pain in extremity FEELING WEAK; MUSCLE ACHE; FEVER (101.4 F); FLU-LIKE SYMPTOMS; ACHY BODY; PAIN IN ARM; This spontan... Read more
FEELING WEAK; MUSCLE ACHE; FEVER (101.4 F); FLU-LIKE SYMPTOMS; ACHY BODY; PAIN IN ARM; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced flu-like symptoms. On 08-APR-2021, the subject experienced achy body. On 08-APR-2021, the subject experienced pain in arm. On 08-APR-2021, the subject experienced fever (101.4 f). Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 09-APR-2021, the subject experienced feeling weak. On 09-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever (101.4 f) on 09-APR-2021, had not recovered from pain in arm, flu-like symptoms, achy body, and feeling weak, and the outcome of muscle ache was not reported. This report was non-serious.
60 2021-04-19 flushing, tremor DELIRIUM; FLUSHED TO FACE; UNCONTROLLED SHAKING; VOMITING; CHILLS; FEVER; This spontaneous report re... Read more
DELIRIUM; FLUSHED TO FACE; UNCONTROLLED SHAKING; VOMITING; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of 60 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to latex (adhesives band aids leave a welt on skin), non-alcohol use, and nonsmoker, and other pre-existing medical conditions included patient did not have any history of drug abuse or illicit drug. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-APR-2021 at 13:00 on left arm for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of report. On 05-APR-2021 at 21:00, the patient experienced delirium, flushed to face, uncontrolled shaking, vomiting, fever and chills. Body temperature (NR: not provided) at 103.5 F. The patient has received paracetamol for fever. The patient consulted a physician at emergency room and physician suggested her to use alternate paracetamol, and ibuprofen to manage symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, uncontrolled shaking, flushed to face, vomiting, chills, and delirium. This report was serious (Other Medically Important Condition).; Sender's Comments: v0;20210417227-covid-19 vaccine ad26.cov2. s-Delirium. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event
60 2021-04-19 pain in extremity, tingling, numbness cold painful toes and numb and tingly finger tips and forearm.
60 2021-04-19 pain in extremity, tenderness, muscle spasms bilateral calf pain bruising, calf tenderness, muscle spasm
60 2021-04-20 feeling hot, tremor This spontaneous report received from a patient concerned a 60 year old female. The patient's weight... Read more
This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 143 kilograms, and height was 65 inches. The patient's past medical history included shingles vaccine, and concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-202113:30 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced heart thumping hard in chest. On 06-APR-2021, the subject experienced foggy feeling in head. On 06-APR-2021, the subject experienced shallow breathing. On 06-APR-2021, the subject experienced violent chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced excruciating headache. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced nausea. Treatment medications included: paracetamol. On an unspecified date, the subject experienced eye running d/t the pain, couldn't stand the light and sound, pure misery, burning up, and full body shaking/came on like a train wreck. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.6 F, 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart thumping hard in chest, and violent chills on 07-APR-2021, shallow breathing, fever, and excruciating headache on 08-APR-2021, and body ache on 09-APR-2021, had not recovered from fatigue, and foggy feeling in head, and the outcome of nausea, full body shaking/came on like a train wreck, eye running d/t the pain, couldn't stand the light and sound, burning up and pure misery was not reported. This report was non-serious.
60 2021-04-20 flushing SORE THROAT; SWOLLEN FACE; TINGLING LIPS; FATIGUE; FLUSHED FACE; This spontaneous report received fr... Read more
SORE THROAT; SWOLLEN FACE; TINGLING LIPS; FATIGUE; FLUSHED FACE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included obstructive sleep apnea, hbp, bipap at night, non-smoker, abstains from alcohol, and seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included colecalciferol for drug used for unknown indication, duloxetine hydrochloride for drug used for unknown indication, hydrochlorothiazide/triamterene for drug used for unknown indication, loratadine for drug used for unknown indication, metoprolol for drug used for unknown indication, orlistat for drug used for unknown indication, and paracetamol. On 12-APR-2021, the subject experienced flushed face. On 12-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced swollen face. On 13-APR-2021, the subject experienced tingling lips. On 14-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen face, tingling lips, and fatigue on 13-APR-2021, was recovering from flushed face, and had not recovered from sore throat. This report was non-serious.
60 2021-04-20 hot flush constantly nauseous,stomach feels bloated,hurts,red dots on arm and neck, hot sweats, all to present... Read more
constantly nauseous,stomach feels bloated,hurts,red dots on arm and neck, hot sweats, all to present date 04/21/21.On 04/08/21 got fever 99.5, body aches & pain,then all of the above stuff to date.
60 2021-04-20 restless legs syndrome, pain in extremity Headaches, restless leg pain in right leg and joint pain
60 2021-04-21 slurring, speech disorder, impaired body coordination Developed visual loss to 20/800, double vision, oscillopsia, ataxia, dysarthria Symptoms started wi... Read more
Developed visual loss to 20/800, double vision, oscillopsia, ataxia, dysarthria Symptoms started with difficulty with speech and loss of depth perception on 04/10/2021 (7 days after COVID vaccine shot) Trial treatment with Solu Medrol 1 gm 5 days and Gammaglobulin 0.4 mg /kg for 5 days. No significant improvement except vision went from 20/800 to 20/400
60 2021-04-21 pain in extremity SORE KNEE; SORE THUMB; This spontaneous report received from a patient concerned a 60 year old femal... Read more
SORE KNEE; SORE THUMB; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer, mastectomy, chemotherapy, and radiation, and concurrent conditions included arthritis, cigarette smoker, abstains from alcohol, and chest tightness, and other pre-existing medical conditions included patient received injection for her arthritis in her back last month. The patient experienced drug allergy when treated with codeine, and paracetamol for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 18:30 for an unspecified indication. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore knee, and sore thumb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore knee, and sore thumb. This report was non-serious.
60 2021-04-22 pain in extremity Sore arm, fatigue and DIZZINESS
60 2021-04-22 cold extremities SWELLING ON THE SIDE OF LEFT NECK; DIFFICULTY SWALLOWING; HANDS AND FEET FREEZING FOR A LONG TIME; C... Read more
SWELLING ON THE SIDE OF LEFT NECK; DIFFICULTY SWALLOWING; HANDS AND FEET FREEZING FOR A LONG TIME; CHILLS AND SHIVERING; SUSPECTED FEVER; HEADACHE; NAUSEA DRY HEAVES; DEHYDRATED; THIRSTY; QUATER SIZE KNOT IN LYMPH GLAND AND SWELLING; FAST HEART BEAT; THROAT TIGHTNESS; ACHYNESS JOINT PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 190 pounds, and height was 155.44 centimeters. The patient's past medical history included covid-19 infection, and concurrent conditions included alcohol use, non smoker, allergy to animal, dust allergy, ragweed allergy, mold allergy, asthma, copd, joint pain, joint swelling, fibromyalgia, osteoarthritis, and drug allergy to tenormin somac metrogel amoxicillin, and other pre-existing medical conditions included the patient had no illness at time of vaccination. the patient had no past history of similar events. the patient had no pre-existing acute illness in 30 days prior to vaccination. the patient had no hospitalization in last 30 days prior to vaccination. the patient had no family history of any disease or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for drug used for unknown indication, budesonide/formoterol fumarate for drug used for unknown indication, and for drug used for unknown indication. On 30-DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On MAR-2021, the subject experienced dehydrated. On MAR-2021, the subject experienced thirsty. On MAR-2021, the subject experienced quarter size knot in lymph gland and swelling. On MAR-2021, the subject experienced fast heart beat. On MAR-2021, the subject experienced throat tightness. On MAR-2021, the subject experienced achyness joint pain. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced nausea dry heaves. On 17-MAR-2021, the subject experienced suspected fever. Laboratory data included: Body temperature (NR: not provided) 99.4 deg. On an unspecified date, the subject experienced swelling on the side of left neck, difficulty swallowing, hands and feet freezing for a long time, and chills and shivering. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills and shivering, headache, nausea dry heaves, dehydrated, thirsty, achyness joint pain, fast heart beat, and throat tightness, had not recovered from quater size knot in lymph gland and swelling, and the outcome of swelling on the side of left neck, difficulty swallowing, hands and feet freezing for a long time and suspected fever was not reported. This report was non-serious. Additional information was received from patient on 16- APR-2021. The following information was updated and incorporated into the case narrative: Patient age group, medical history(alcohol use, non smoker, allergy to animal, dust allergy, ragweed allergy, mold allergy, asthma, COPD, joint pain, joint swelling, fibromyalgia, osteoarthritis, and drug allergy to tenormin somac metrogel amoxicillin), events( chills and shivering, headache, nausea dry heaves, dehydrated, thirsty, achyness joint pain, fast heart beat, and throat tightness, quarter size knot in lymph gland and swelling), outcome updated, causality; Sender's Comments: This case was non serious
60 2021-04-24 numbness, pain in extremity, burning sensation Day one post vaccination - dull headache, leg pain, abdominal pain, back pain - these symptoms conti... Read more
Day one post vaccination - dull headache, leg pain, abdominal pain, back pain - these symptoms continued for a few days, I started to feel a bit better, did not take any pain reliever medications because I didn't want to mask symptoms. On 4/14/21, 7 days post vaccination, my leg pain in both legs worsened including numbness and a burning sensation in both feet. Back pain continued, arm pain started in both arms with numbness in both hands however the pain on my left side with legs and arms is worse. I've had intermittent shooting pains in my left ear, left jaw, left temple and across the left side of my face. I've also experienced shoulder and neck pain. The abdominal pain is intermittent and mild. On 4/15 - 4/18 the pain in my legs was so bad that it was waking me up at night and my arm pain was occurring more frequently. I decided to go to the ER on 4/18, day 11 post vaccination, due to my concern of a possible DVT or other type of blood clot. The ER physician's assistant did not look at my legs but did several blood tests and other tests.
60 2021-04-25 feeling hot, pain in extremity, night sweats AT 2:00 A.M.HAD THE SWEATS BURNING UP NEEDED TO TAKE SHOWER TO COOL DOWN THAN HAD CHILLS AND BODY AC... Read more
AT 2:00 A.M.HAD THE SWEATS BURNING UP NEEDED TO TAKE SHOWER TO COOL DOWN THAN HAD CHILLS AND BODY ACHES, AND HEADACHE STARTED, HAD A HARD TIME FUNCTIONING. THIS WENT ON FOR TWO DAYS THEN HEADACHE FOR A WEEK AND LEGS WERE PAINFUL TO WALK STILL ARE HEADACHE GONE BUT PAIN IN LEGS, STILL TAKING ADVIL ITS BEEN TWO WEEKS SINCE THE SHOT.
60 2021-04-25 pain in extremity Extreme swelling 2 weeks after vaccine. A lot of bruising. Left hard very sore size of quarter place... Read more
Extreme swelling 2 weeks after vaccine. A lot of bruising. Left hard very sore size of quarter place on right arm. Blood a lot when injection was done.
60 2021-04-26 weakness weak, loss of Appetite called 911 transported to Hospital 4/21-patient still having issues with eati... Read more
weak, loss of Appetite called 911 transported to Hospital 4/21-patient still having issues with eating , patient was dehydrated . went to hospital , got out now
60 2021-04-26 hot flush HIGH BLOOD PRESSURE; PULSE PRESSURE OF 106; FEELING OF FLUSH; DELTOID/SHOULDER SITE SORENESS; This s... Read more
HIGH BLOOD PRESSURE; PULSE PRESSURE OF 106; FEELING OF FLUSH; DELTOID/SHOULDER SITE SORENESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting, the patient had no known allergies and the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the patient experienced feeling of flush (she stated that it felt like a heat coming through), high blood pressure of 103/101 (units unknown) and pulse pressure 106 (units unknown). She also experienced the deltoid/shoulder site soreness which lasted for 1 to 2 days. On an unspecified date she went to emergency room, she had blood pressure 240/140: high (units unknown) and pulse pressure (units unknown). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deltoid/shoulder site soreness on 13-APR-2021, was recovering from feeling of flush, had not recovered from high blood pressure, and the outcome of pulse pressure of 106 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210430543-covid-19 vaccine ad26.cov2. s-High blood pressure This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
60 2021-04-26 numbness, muscle twitching, pain in extremity DIZZINESS; FATIGUE; NOT FEELING WELL; ELEVATED PLATELETS; LOW CLOTTING TIME; ELEVATED EOSINOPHILS; L... Read more
DIZZINESS; FATIGUE; NOT FEELING WELL; ELEVATED PLATELETS; LOW CLOTTING TIME; ELEVATED EOSINOPHILS; LEFT SIDE PAIN STARTING FROM THE LEFT BREAST DOWN TO THE HIP; LEFT FACIAL SWELLING; FACIAL NUMBNESS; LEFT EYE TWITCHING; IMPAIRED VISION IN LEFT EYE; LEFT LEG NUMBNESS; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, and other pre-existing medical conditions included the patient was not diabetic, not on blood thinners prior to going to the hospital, and does not take thyroid medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered to the left arm, on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced left side pain starting from the left breast down to the hip. On 27-MAR-2021, the subject experienced left facial swelling. On 27-MAR-2021, the subject experienced facial numbness. On 27-MAR-2021, the subject experienced left eye twitching. On 27-MAR-2021, the subject experienced impaired vision in left eye. On 27-MAR-2021, the subject experienced left leg numbness. On 27-MAR-2021, the subject experienced left arm pain. On 29-MAR-2021, the subject experienced elevated platelets. On 29-MAR-2021, the subject experienced low clotting time. On 29-MAR-2021, the subject experienced elevated eosinophils. On 29-MAR-2021, the subject experienced not feeling well. Laboratory data included: CT scan (NR: not provided) unknown, Clotting time (NR: not provided) LOW, Eosinophil count high (NR: not provided) UNKNOWN, MRI (NR: not provided) unknown, Mean platelet volume (NR: not provided) LOW, and Platelets increased (NR: not provided) 10 times above normal. On 30-MAR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side pain starting from the left breast down to the hip, facial numbness, left eye twitching, impaired vision in left eye, left arm pain, and fatigue on 2021, and dizziness on APR-2021, was recovering from left facial swelling, and not feeling well, had not recovered from left leg numbness, and the outcome of elevated platelets, elevated eosinophils and low clotting time was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious
60 2021-04-26 muscle spasms ABDOMINAL PAIN; BRUISES ON LEG AND RIGHT ARM; CRAMPING ON LEG; This spontaneous report received from... Read more
ABDOMINAL PAIN; BRUISES ON LEG AND RIGHT ARM; CRAMPING ON LEG; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Lyme disease, shellfish allergy, allergy to an unknown antibiotic, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced abdominal pain. On 12-APR-2021, the subject experienced bruises on leg and right arm. On 12-APR-2021, the subject experienced cramping on leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain, bruises on leg and right arm, and cramping on leg. This report was non-serious.; Sender's Comments: v0-Medical assessment comment is not required as the case is assessed as non-serious.
60 2021-04-26 pain in extremity Headache everyday for over 2 weeks now, has not gone away. Arm is still sore
60 2021-04-26 pain in extremity HIGHER LEVEL OF PAIN (EXTREME PAIN) IN THE SHOULDER AND IN UPPER ARM; LACK OF MOBILITY IN THE SHOULD... Read more
HIGHER LEVEL OF PAIN (EXTREME PAIN) IN THE SHOULDER AND IN UPPER ARM; LACK OF MOBILITY IN THE SHOULDER AND THE UPPER ARM OF THE INJECTED SITE; FROZEN SHOULDER; HIGHER LEVEL OF PAIN (EXTREME PAIN) AT THE LOCATION OF INJECTION; SORE ARM; LITTLE FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included immune thrombocytopenic purpura, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, the subject experienced little fatigue. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) in the shoulder and in upper arm. On 24-APR-2021, the subject experienced lack of mobility in the shoulder and the upper arm of the injected site. On 24-APR-2021, the subject experienced frozen shoulder. On 24-APR-2021, the subject experienced higher level of pain (extreme pain) at the location of injection. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) Platelet count before the vaccination was 40. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little fatigue on 03-APR-2021, and had not recovered from sore arm, higher level of pain (extreme pain) at the location of injection, lack of mobility in the shoulder and the upper arm of the injected site, higher level of pain (extreme pain) in the shoulder and in upper arm, and frozen shoulder. This report was non-serious.
60 2021-04-27 hot flush CHEST PAIN; SHORTNESS OF BREATH; TROUBLE FALLING ASLEEP; HOT FLASH; EXTREME FATIGUE; HEADACHE; This ... Read more
CHEST PAIN; SHORTNESS OF BREATH; TROUBLE FALLING ASLEEP; HOT FLASH; EXTREME FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included progesterone for prevent breast cancer, and estradiol for prevent osteoporosis. On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced trouble falling asleep. On 18-APR-2021, the subject experienced hot flash. On 18-APR-2021, the subject experienced extreme fatigue. On 18-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chest pain, and shortness of breath, and the outcome of extreme fatigue, trouble falling asleep and hot flash was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
60 2021-04-27 tingling, pain in extremity On and off symptoms include: light headedness, light weakness/tingle on the underside of my left ar... Read more
On and off symptoms include: light headedness, light weakness/tingle on the underside of my left arm, on and off achey weakness in right hand too. It started on day 12, 13, 15 (up to two weeks after vaccination). Symptoms went away and returned at night on April 27 and throughout the day on April 28, 2021. I was borne with mitral valve prolapse (no work/life restrictions) and wondered if the vaccine has any connection to the mitral valve prolapse.
60 2021-04-28 pain in extremity ARM PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patien... Read more
ARM PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 100 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up The patient received macitentan (form of admin unknown, oral, batch number: ZE019B0101 expiry: UNKNOWN) 10 mg, 1 time, therapy dates were not reported for an unspecified indication. Non-company suspect drugs included: epoprostenol sodium (intravenous, batch number: MM248M0101 expiry: 30/JUN/2022, form of admin was not reported) 20 mg, frequency, and therapy dates were not reported for an unspecified indication. Concomitant medications included warfarin non-company for drug used for unknown indication, and riociquat non-company. On an unspecified date, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of arm pain was not reported. This report was non-serious.
60 2021-04-28 pain in extremity LEG SWOLLEN; CANNOT PUT PRESSURE ON FOOT, WALKS ON TIP TOES; TENDERNESS ON OUTSIDE OF LEFT LEG; PA... Read more
LEG SWOLLEN; CANNOT PUT PRESSURE ON FOOT, WALKS ON TIP TOES; TENDERNESS ON OUTSIDE OF LEFT LEG; PAINFUL KNEE/LEG; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure abnormal, knee disorder, and hand arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included methotrexate for hand arthritis, and acetylsalicylic acid. On 10-APR-2021, the subject experienced leg swollen. On 10-APR-2021, the subject experienced cannot put pressure on foot, walks on tip toes. On 10-APR-2021, the subject experienced tenderness on outside of left leg. On 10-APR-2021, the subject experienced painful knee/leg. On 14-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No blood clots. On 20-APR-2021, Laboratory data included: Blood test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tenderness on outside of left leg, painful knee/leg, leg swollen, and cannot put pressure on foot, walks on tip toes. This report was non-serious.
60 2021-04-28 tingling left calve tingling at night.
60 2021-05-04 weakness Fever,coughing,sob,severe weakness over 4day perios,went into resp distress,unable to raise up becam... Read more
Fever,coughing,sob,severe weakness over 4day perios,went into resp distress,unable to raise up became no strength
60 2021-05-04 muscle spasms SPORADIC NOSE BLEEDS; LEG CRAMPS IN CALVES LIKE CHARLIE HORSE; CONSTANT HEADACHE; EXTREME FATIGUE; T... Read more
SPORADIC NOSE BLEEDS; LEG CRAMPS IN CALVES LIKE CHARLIE HORSE; CONSTANT HEADACHE; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sporadic nose bleeds. On APR-2021, the subject experienced leg cramps in calves like charlie horse. On APR-2021, the subject experienced constant headache. On APR-2021, the subject experienced extreme fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant headache, and the outcome of sporadic nose bleeds, leg cramps in calves like charlie horse and extreme fatigue was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
60 2021-05-04 pain in extremity, night sweats, migraine, burning sensation BOTH LEGS HURT (HAD SHOOTING PAIN/ ON RIGHT LEG) AND BELOW THE KNEE AREA; SWEATING; MIGRAINE WHICH L... Read more
BOTH LEGS HURT (HAD SHOOTING PAIN/ ON RIGHT LEG) AND BELOW THE KNEE AREA; SWEATING; MIGRAINE WHICH LEAD TO NOT TO SLEEP; ACHINESS ALL OVER THE BODY; CHILLS; NAUSEA FELT LIKE HAD FLU; HEADACHE; BURNING SENSATION; INFLAMMATION OF BOTH LEGS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not do well with drugs generally. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced inflammation of both legs. Treatment medications included: ibuprofen. On 12-APR-2021, the subject experienced burning sensation. On 12-APR-2021, the subject experienced migraine which lead to not to sleep. On 12-APR-2021, the subject experienced achiness all over the body. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced nausea felt like had flu. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) sub normal 97.5. On 12-APR-2021 02:00, the subject experienced sweating. On 28-APR-2021, the subject experienced both legs hurt (had shooting pain/ on right leg) and below the knee area. Laboratory data included: Blood test (NR: not provided) normal. On 29-APR-2021, treatment medications included: methylprednisolone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation, and sweating on 13-APR-2021, migraine which lead to not to sleep on 19-APR-2021, chills on 14-APR-2021, and headache on APR-2021, and was recovering from nausea felt like had flu, achiness all over the body, both legs hurt (had shooting pain/ on right leg) and below the knee area, and inflammation of both legs. This report was non-serious.
60 2021-05-05 migraine Migraine headache for a week, had a MRI of the brain to rule out blood clots. A torn rotor cuff th... Read more
Migraine headache for a week, had a MRI of the brain to rule out blood clots. A torn rotor cuff that happened 10 years ago that was a no issue, became very painful and inflamed to the point of needing a Cortisone shot and MRI to see what is going on.
60 2021-05-05 pain in extremity Pain at Injection Site-Medium, Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-M... Read more
Pain at Injection Site-Medium, Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Severe, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Severe, Additional Details: recieved shot at 3:10pm, patient reported severe arm pain, nausea, blurred vision. 1st bp: 96/66 pulse 64 at 3:34pm, 2nd bp:102/68 pulse 62 at 3:50pm, 3rd bp 122/76 pulse 68 at 4:04pm. advised pt not to drive and left pharmacy around 4:10pm, observed patient for over 30mins due to use of epipen for cipr allergy in past
60 2021-05-07 muscle twitching on or about 5/4/21 noticed a rash on both legs they had been itchy prior to that, the rest of my bod... Read more
on or about 5/4/21 noticed a rash on both legs they had been itchy prior to that, the rest of my body is itchy w a few rash spots present. 5/8/21 noticed my left thumb twitching. As far as Item 20 rash is still still present and the thumb twitching is still present
60 2021-05-10 migraine, burning sensation 4/6/2021 vaccination. Within an hour, I had hives .5", and spread to smaller all over body. I had a ... Read more
4/6/2021 vaccination. Within an hour, I had hives .5", and spread to smaller all over body. I had a hard time breathing. I was fine for the first 15 minutes. I started to get itchy, neck started to hurt. My head was all broken out. All down my legs. An hour or 2 later is when it started to itch really bad. Burning going down my arm. I went to work and worked rest of the day, hard time breathing. I had major stomach ache. I couldn't eat. The HA kicked in and had asthma attack. Fever started; 102. Stomach cramps. HA was severe for quite a while. Seven days later, I called my doctor. 4/13/2021 Saw PCM; Pneumonia and sinus infection. Put on upper respiratory medication; Sefedna. *Migraine for 12 days, became a HA for almost a whole month. 102 FEVER lasted 7 days vomiting for 2.5 weeks body aches, chills, teeth chattering; first 2 days extreme fatigue 4/12 or 4/19 (?); COVID + *still experiencing muscle and joint pain *felt like breathing bleach whole time
60 2021-05-11 muscle spasms I experienced acute onset of dizziness with chest pain, shaking chills, muscle spasms in my legs, he... Read more
I experienced acute onset of dizziness with chest pain, shaking chills, muscle spasms in my legs, headaches and nausea. I went to hospital where they did lab work, 1280 EKG, gave me fluids, and gave me Zofran medication. They also gave me a prescription for meclizine. They also did a Covid test which was negative. I saw my PCP on 04-11-2021 who ordered a chest x-ray and lab work. I also saw my PCP 05-11-2021, because I had a TIA on Sunday 05-09-2021. I still being worked up on lab work, TIA and an MRI has been ordered for next Monday 05-17-2021.
60 2021-05-12 weakness As the 2nd week came I started feeling slightly tired/weak, but going into the 3rd week I felt that ... Read more
As the 2nd week came I started feeling slightly tired/weak, but going into the 3rd week I felt that my inhaler was filed with pepper spray. On wed going home had bad cough. Then Thursday , left work early, had to go home. On the way there was like a circle of fire going around my heart to include that part of lungs. Had to bed rest till Monday. Dr. at Emergency gave a prescription of Antibiotics and a cough prescription, my son had to pick it up for me. Then a bout a week later I had finished dinner, taking my plate to the kitchen, body/brain completely quit. No time to get dizzy, speak out or say anything. JUST QUIT. My husband said I was in/out for about 10 minutes as he was trying to help me up. Right side of nose/head still has problems.
60 2021-05-15 trigeminal neuralgia Severe Headache, Triggered Trigeminal Neuralgia, Rash, Fever, Large swelling at vaccine site, Short ... Read more
Severe Headache, Triggered Trigeminal Neuralgia, Rash, Fever, Large swelling at vaccine site, Short of Breath
60 2021-05-17 migraine Fatigue, HA and migraine, neck pain, body aches, diarrhea that have lasted 4 days. Pt has taken Tyle... Read more
Fatigue, HA and migraine, neck pain, body aches, diarrhea that have lasted 4 days. Pt has taken Tylenol, Meloxicam, and Sumatriptan with mild improvement after medication but HA returns later. Diarrhea has improved. No improvement in body aches or fatigue
60 2021-05-18 hot flush FLUTTERING FEELING AROUND HEART; HOT FLASHES; This spontaneous report received from a patient concer... Read more
FLUTTERING FEELING AROUND HEART; HOT FLASHES; This spontaneous report received from a patient concerned a 60 year old Not Hispanic or Latino African American female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, menopause and other pre-existing medical conditions included the patient had drug allergies. past unremarkable history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, 1 in total administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced hot flashes and On 07-APR-2021 experienced cardiac flutter and fast beating of heart. She stated hot flashes symptoms come and go and sometimes had this feeling after eating peppermint candy, unknown if she had peppermint candy before receiving the Janssen COVID-19 vaccine. Her medical doctor was not yet notified and she had not treated her symptoms with any over the counter medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes and cardiac flutter. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210523500-Covid-19 vaccine ad26.cov2.s -Fluttering feeling around heart. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
60 2021-05-23 electric shock sensation I woke up at 5am and when I sat up, I slumped over. I sat up again, stayed for 30 sec, went to the b... Read more
I woke up at 5am and when I sat up, I slumped over. I sat up again, stayed for 30 sec, went to the bathroom and when I came back, I experienced severe dizziness. For the next 4 hours, I couldn't move my head and would get a zing right up the back of my neck. When I tried to sit up again, I got really sick to my stomach. After 8 hours, I started feeling better and was able to sleep on either side, but not on my back. When I was on my back everything would start spinning again. By the afternoon of the next day, I was feeling better, but was afraid to move my head too much because I didn't want everything to start up again, so I went to the doctor. My BP was high, so he had me lay on the table. He turned my head and set it off again, so I was miserable again for the next 10 hours. After that, I felt better and was able to get up and function.
60 2021-05-23 numbness Hands have turned black inside palms and fingers. The knuckles and base of the palm and wrist looks ... Read more
Hands have turned black inside palms and fingers. The knuckles and base of the palm and wrist looks burnt. Have no feeling in fingers, they feel very numb, If i make a fist ,It's very tight and can feel heart beating in the palm of hands. The black burnt look has moved to both inside and outside of hands
60 2021-05-23 pain in extremity I am filling out this report today because I received a follow up call from the website because I ha... Read more
I am filling out this report today because I received a follow up call from the website because I had reported loss work, loss of job, loss of activity and visits to doctors. I received the vaccine on March 12, 2021, I started having arm and shoulders symptoms the day after getting the vaccine but did not feel well that first night while trying to sleep. The symptoms worsened every day, I am in week 11 post vaccination. I have had 22 medical appointments with 3 to PCP, 13 to Physical Therapy who diagnosed left bicep tendinitis and shoulder impingement many weeks ago, 4 to acupuncture, and 1 to xray. This Thursday I finally get an MRI. I lost my job on week 7 after the vaccine, I can barely use my left arm, I live alone, I am exhausted and spend much time chasing a diagnosis or help in resolving this issue. I reported to website every time the link was sent to me. I called the Pharmacy on Day 3 and called Janssen hotline on Day 3 to report a reaction. I wrote to my doctor on Day 5 to say something was not right. By the next day I had an injection site reaction, very hard swelling in my arm, a dark red jagged surface reaction at the injection site now there is a divot there. Feeling very unwell, aches and pains, no fever. I had bad abdominal cramps that night after the injection, diarrhea for days, arm pain with swelling, joint pain in shoulder, knee, and fingers, and a rash across my back, I had to continue to work, typing fast 9 to 10 hours a day, I am a self-employed contractor doing tax technical support and the pain in my arm grew worse daily, I was in tears trying to work. Sitting to type, to read, to drive is the worse. I can dictate into my devices but not rapidly enough for the level of my work. The worse pain in my arm and shoulder is less by avoiding typing and driving but the injury is still there. The pain is constant even without movement.
60 2021-05-24 numbness POSSIBLE SMALL STROKE; POSSIBLE TRANSIENT ISCHAEMIC ATTACK (TIA); SUPER DIZZY; THROWING UP; COULD NO... Read more
POSSIBLE SMALL STROKE; POSSIBLE TRANSIENT ISCHAEMIC ATTACK (TIA); SUPER DIZZY; THROWING UP; COULD NOT OPEN EYES; WIERDLY AND EXCEEDINGLY THIRSTY; COULD NOT WALK; NUMBNESS IN LEFT ARM; COULD NOT STAND; HEAVINESS IN LEFT ARM; NAUSEOUS; HEADACHE; FELT LIKE HAD CHILLS LIKE ONE GETS FROM THE FLU; This spontaneous report received from a patient concerned a 60 year old White, Not Hispanic or Latino female. The patient's weight was 175 pounds, and height was 65 inches. The patient's concurrent conditions included slightly elevated blood pressure, alcohol user socially and on weekends, non smoker, and penicillin allergy since childhood. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included valsartan for elevated blood pressure, acetylsalicylic acid, and furosemide. On 10-MAR-2021, the patient felt like having chills like getting from the flu, for couple of hours might be, a headache for several days, might be for 3 days. For that the patient took some Advil 200 mg every 6 hours for the first couple of days. Then that passed and felt fine. On 24-APR-2021, around 04:00 in the morning the patient woke up and felt weirdly thirsty, exceedingly thirsty and super dizzy, nauseous thought was having a heart attack and heaviness and numbness in left arm but could still move the arm, however could not walk and could not open eyes until was in hospital. As a treatment Aspirin was given to the patient by husband. The patient was throwing up, could not stand. About 05:30 went to the hospital and ran many tests. Ruled out brain bleed, heart attack, anything cardiac did a CAT scan; bloodwork found that the patient was low in potassium and it was determined that the patient either had a small stroke or a TIA that dissipated on its own. The patient saw her cardiologist and wore a Holter monitor for 10 days. The patient also has an appointment with a neurologist coming up in June and having another CAT scan. Also seeing a vascular neurologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from possible small stroke, possible transient ischaemic attack (TIA), super dizzy, could not open eyes, wierdly and exceedingly thirsty, could not walk, throwing up, numbness in left arm, could not stand, heaviness in left arm, and nauseous on 2021, felt like had chills like one gets from the flu on 10-MAR-2021, and headache on MAR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: covid-19 vaccine ad26.cov2.s-Possible small stroke, Possible transient ischaemic attack , super dizzy, could not open eyes, wierdly and exceedingly thirsty, could not walk, throwing up, numbness in left arm, could not stand, heaviness in left arm. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. covid-19 vaccine ad26.cov2.s-Nauseous. This event is labeled per RSI and is therefore considered potentially related.
60 2021-05-24 pain in extremity I had trouble breathing for two days and had a sore arm within 5 minutes of having the injection. An... Read more
I had trouble breathing for two days and had a sore arm within 5 minutes of having the injection. And pain in my left leg is still ongoing.
60 2021-05-25 pain in extremity After my first dose I experienced- body aches, left arm soreness and stomach pain which lasted a cou... Read more
After my first dose I experienced- body aches, left arm soreness and stomach pain which lasted a couple of days.
60 2021-05-26 weakness, tremor 2 hours after shot I felt weak for 2 hours I started to get an itchy rash the same night and my lef... Read more
2 hours after shot I felt weak for 2 hours I started to get an itchy rash the same night and my left arm swelled. The shot location in my left arm itched a lot. I scratched it, it bled. It became a large hole. 3 days later approximately, I start feeling very very tired. It got progressively worse . I then developed " brain fog". I have barely been able to work since then.. I believe I started to recover yesterday but not completely sure yet. I also developed a painful tumor in my right arm pit that lasted for a few days. It has since gone away. It was approximately 3/4 " in size. It developed overnight.
60 2021-05-26 night sweats I just really got dizzy to point I felt like my head was swimming. I could not lay on my back, that... Read more
I just really got dizzy to point I felt like my head was swimming. I could not lay on my back, that also cause dizziness. I also broke out in sweats in the middle of the night.
60 2021-05-26 pain in extremity, weakness Arm hurt as soon as I got the injection. The next day and every since. I have headaches. Awful neck ... Read more
Arm hurt as soon as I got the injection. The next day and every since. I have headaches. Awful neck pain,weakness,tired, coughing, pain in back. Using Tylenol doesn't help much..I will feel fine for a day then it comes back
60 2021-05-27 pain in extremity, tremor Five hours after vaccine around 8 PM I started with chills and shakes and then fever. I think I had ... Read more
Five hours after vaccine around 8 PM I started with chills and shakes and then fever. I think I had a fever of over 100. No body aches or anything like that, of coarse there was a little bit of soreness in arm but it wasn't so bad. 3 weeks later is when I started with headache which I recognized as sinus so I started medical treatment I went to see a doctor about a month later on 05/03/2021 and that is when I was put on antibiotics for 10 days and steroids. It ended up going away maybe halfway through taking the antibiotics, about 5 days in using antibiotics around 05/08/2021 I started feeling better.
60 2021-05-28 pain in extremity Bad pain down leg , swollen leg, very sharp pain that move into foot . foot swells everyday since va... Read more
Bad pain down leg , swollen leg, very sharp pain that move into foot . foot swells everyday since vaccine
60 2021-05-29 muscle twitching Weird white swollen line just below lower lip Twitching between eye/ lower forehead
60 2021-05-31 migraine pt says she had bad migraines after taking the vaccine. Her left arm is still sore, red and inflame... Read more
pt says she had bad migraines after taking the vaccine. Her left arm is still sore, red and inflamed at the injection site. (it has been months) Then she had itching all over. She took a shower and then noticed she had a bump on chest, then on her arms, and her both legs, stomach, back, and breast. These bumps appear like little blisters and then burst and scar her skin like a cigarette burn. Most are small but there are some larger ones. She says like look the measles. She went to her PCP Dr. She was told she was having a reaction to the vaccine and to come back if it got worse. Pt will reach back out to her doctor for medical advice.
60 2021-05-31 pain in extremity My big toes began hurting really bad. They got hot and reddish. They hurt for about an entire day. I... Read more
My big toes began hurting really bad. They got hot and reddish. They hurt for about an entire day. I put fungi with extra tea tree oil. That calmed it down. The right foot pain and discoloration completely stopped. On the left foot went to a reddish purple to an opal color. It then varied to a reddish purple again. It is discolored in my toenail. It lightens and gets darker. The pain and discoloration went on for about a week. The pain is gone but the discoloration is still present. The Tuesday after mother's day I cut my finger and received stitches. Along with the stiches I also received a tetanus shot. I received the tetanus shot in my right arm but I developed a painful knot in both my COVID arm and my tetanus arm. I put neosporin and a bandaid and massaged them which helped. The knots are going away but they haven't completely disappeared.
60 2021-06-08 pain in extremity When I received the shot I had no reaction at all not even a sore arm. Within a few days I started ... Read more
When I received the shot I had no reaction at all not even a sore arm. Within a few days I started getting terrible pains in the calves of my legs. Then a few days later I got a purple line on my right calf that was painful. The next day I had 3 big yellow spots on the same leg. They went away in 2 days which I thought was odd. Next day I got a very large bruise at the vaccine location. After that I started with pains in all of my joints. Ever since then I have been having pains in all my joints. The pain level is not going away and has been getting worse
60 2021-06-08 tingling Complained of tingling in the left arm. Denies chest and shortness of breath. No dizziness or headac... Read more
Complained of tingling in the left arm. Denies chest and shortness of breath. No dizziness or headache. Observed for an additional thirty minutes to the initial fifteen minutes. Patient expressed relief of tingling at end of observation.
60 2021-06-09 burning sensation After my vaccine, I broke out in a rash, felt like someone was burning me, like if I was burning me ... Read more
After my vaccine, I broke out in a rash, felt like someone was burning me, like if I was burning me alive, hard to explain. It was a rash then the rash turned into these big red mass, these lumps were nasty and I could not sleep for three days. They were on my arms and legs, stomach, back, parts of my face. The rash went away and came back, was on different parts of my body. I went to the ER to get checked out but at the ER they did not do any exams for me, they just told me I had hives. It took 4-5 days for my hives to go away. I still get these little bumps, they are small growing around my back, chest and legs and at the bottom of my legs and body and they do not itch.
60 2021-06-11 weakness PAINFUL RASH ON RIGHT ARM AND HAND, LEFT ARM, LEGS, HEAD,BACK,FACE; WEAKNESS; HEADACHE SO BAD LIKE A... Read more
PAINFUL RASH ON RIGHT ARM AND HAND, LEFT ARM, LEGS, HEAD,BACK,FACE; WEAKNESS; HEADACHE SO BAD LIKE A MIGRAINE; FEVER; MUSCLE ACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 189 pounds, and height was 64 inches. The patient's concurrent conditions included cancer, thyroid and other pre-existing medical conditions included patient receives steroid knee injection, left knee only every 3 months. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included anastrozole for cancer, ibuprofen for drug used for unknown indication, and paracetamol for drug used for unknown indication. On 22-MAR-2021, the subject experienced weakness. On 22-MAR-2021, the subject experienced headache so bad like a migraine. On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced muscle ache. On 04-APR-2021, the subject experienced painful rash on right arm and hand, left arm, legs, head, back, face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weakness, and fever on 26-MAR-2021, and headache so bad like a migraine, and muscle ache on 25-MAR-2021, and was recovering from painful rash on right arm and hand, left arm, legs, head, back, face. This report was non-serious.
60 2021-06-12 numbness, slow speech As soon as the vaccine was given, I was lightheaded ,dizzy and difficulty walking. My left hand wen... Read more
As soon as the vaccine was given, I was lightheaded ,dizzy and difficulty walking. My left hand went numb and I felt the vaccine travel through my system. I had to be helped to the 15 minute waiting area where I grew nauseous and continued to feel dizzy and light headed. The paramedics were called but my vital signs were normal. I came home and slept for 12 hours. By Saturday ( 4 days ) after the vaccine, I felt like I was in a fog, couldn't think straight, and my speech become slow. Once I got to the ER, I was having delusions and was convinced my deceased dog was sitting on my lap.
60 2021-06-12 tingling Tingling around nose and mouth. Cold water given, reactions are starting to be relieved after drinki... Read more
Tingling around nose and mouth. Cold water given, reactions are starting to be relieved after drinking water.
60 2021-06-13 tingling, pain in extremity I had leg pain, lymph nodes were swollen on the left side, pain down the right arm and tingling in m... Read more
I had leg pain, lymph nodes were swollen on the left side, pain down the right arm and tingling in my fingers, dizzy spells, back and head pain.
60 2021-06-16 bell's palsy Bell's palsy Right. since April 24,2021 He was seen at MEDICAL CENTER, s/p acyclovir, prednisone tr... Read more
Bell's palsy Right. since April 24,2021 He was seen at MEDICAL CENTER, s/p acyclovir, prednisone treatment. pt. states 50% improving It was noted that he had J&J Covid19 vaccine. Pt. advised to report it to Vsafe. It will also be reported to VAERS.
60 2021-06-16 mild one side paralysis Patient became dizzy upon standing and experience left sided weakness. Ambulance was called and pati... Read more
Patient became dizzy upon standing and experience left sided weakness. Ambulance was called and patient transported to hospital. Upon exam it was determined the patient had a bleed on the ride side of the brain. After 4 or 5 days she was transferred to Rehab. She was then sent back to hospital after complications. Patient began having kidney problems and was undergoing dialysis. 06/16/2021 patient began having bad headaches, CT scan showed multiple previous strokes(clots). Patient currently still in hospital.
60 2021-06-16 pain in extremity SENSITIVE MOUTH; DIMINISHED TASTE; FOOD TASTED FUNNY HAD WEIRD TEXTURE; SKIN ON MOUTH FELT BURNT OR ... Read more
SENSITIVE MOUTH; DIMINISHED TASTE; FOOD TASTED FUNNY HAD WEIRD TEXTURE; SKIN ON MOUTH FELT BURNT OR DEAD; PEELING OF SKIN ON MOUTH; SORE ARM; COVID TONGUE OR WHITE SPOTS ON TONGUE AND BACK OF TONGUE WAS ALSO WHITE; TOP OF TISSUE WAS DEAD OF MOUTH; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 205 kilograms, and height was 63 inches. The patient's past medical history included thyroid cancer, and thyroidectomy, and concurrent conditions included type 2 diabetic, and environmental allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced covid tongue or white spots on tongue and back of tongue was also white. On APR-2021, the subject experienced top of tissue was dead of mouth. On 10-APR-2021, the subject experienced peeling of skin on mouth. On 10-APR-2021, the subject experienced food tasted funny had weird texture. On 10-APR-2021, the subject experienced skin on mouth felt burnt or dead. On 10-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced sensitive mouth. On 11-APR-2021, the subject experienced diminished taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from peeling of skin on mouth on 06-MAY-2021, and sore arm on 11-APR-2021, had not recovered from sensitive mouth, diminished taste, and food tasted funny had weird texture, and the outcome of skin on mouth felt burnt or dead, covid tongue or white spots on tongue and back of tongue was also white and top of tissue was dead of mouth was not reported. This report was non-serious.
60 2021-06-18 numbness, tingling Right Hand and Arm feels tingling numbness ichy and major weakness. At times feels as though hand a... Read more
Right Hand and Arm feels tingling numbness ichy and major weakness. At times feels as though hand and arm are asleep. Lost functionality in hand at times.
60 2021-06-20 pain in extremity, muscle spasms, feeling hot LIGHTHEADEDNESS/DIZZINESS; MUSCLE CRAMPS/CRAMPING IN ARMS AND LEGS; ABDOMINAL PAIN (DESCRIBED AS LAB... Read more
LIGHTHEADEDNESS/DIZZINESS; MUSCLE CRAMPS/CRAMPING IN ARMS AND LEGS; ABDOMINAL PAIN (DESCRIBED AS LABOUR PAIN)/ STOMACH MUSCLES SORENESS; FELT WARM WITH NO FEVER; BURPING; DIFFICULTY IN SLEEPING; CHILLS; SORE ARM PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and concurrent conditions included diabetes, and bipolar disorder. The patient experienced drug allergy-rash when treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: FC 202A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced back pain. On 07-JUN-2021, the subject experienced sore arm pain. On 16-JUN-2021, the subject experienced muscle cramps/cramping in arms and legs. On 16-JUN-2021, the subject experienced abdominal pain (described as labour pain) / stomach muscles soreness. On 16-JUN-2021, the subject experienced felt warm with no fever. On 16-JUN-2021, the subject experienced burping. On 16-JUN-2021, the subject experienced difficulty in sleeping. On 16-JUN-2021, the subject experienced chills. On 17-JUN-2021, the subject experienced lightheadedness/dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps/cramping in arms and legs, abdominal pain (described as labour pain)/ stomach muscles soreness, and difficulty in sleeping on 16-JUN-2021, and back pain, burping, chills, and sore arm pain on 17-JUN-2021, and had not recovered from lightheadedness/dizziness, and felt warm with no fever. This report was non-serious.
60 2021-06-21 pain in extremity left shoulder pain pain goes down to fingers . can not apply pressure. like fire and ants at times.
60 2021-06-22 inability to speak The evening after the vaccination, it triggered my asthma. I consulted my doctor and started breathi... Read more
The evening after the vaccination, it triggered my asthma. I consulted my doctor and started breathing treatments (levoalbuterol) twice a day. At 5 days post vaccine, the asthma improved but I came down with a very sore throat and also noticed a enlarged lymph node. It was so painful I could not talk or eat. I was tested for strep and was negative. I was prescribed budesonide to calm down the inflammation and I took cough drops. I am still suffering from sore throat but it getting better. Right below my jaw line, I have an enlarged lymph node that is sore to the touch. I am having difficulty swallowing, talking and eating. I am still having these symptoms.
60 2021-06-23 pain in extremity 4 days after injection patient had localized redness and itching. The area is slightly warm to the t... Read more
4 days after injection patient had localized redness and itching. The area is slightly warm to the touch and whole arm had mild pain. hard to say if infected or cellular allergic reaction. Advised patient to take an oral OTC antihystamine and if signs/symptoms persisted or get worse, to seek medical attention.
60 2021-06-25 weakness, numbness Pt's husband came in today (6/26/2021) and reported that ten days after receiving the shot (6/15/21)... Read more
Pt's husband came in today (6/26/2021) and reported that ten days after receiving the shot (6/15/21), his wife (the patient) started feeling weak and felt numbness in her legs. She is currently in the ICU being treated. They believe it may have been because of the shot. Blood clot has not been confirmed.
60 2021-06-25 feeling cold Get tire extremely fast when walking daily Shortness of breath daily Swollen ankles daily Headache... Read more
Get tire extremely fast when walking daily Shortness of breath daily Swollen ankles daily Headaches every morning when I wake up Pressure in left eye often Body was cold the night of the vaccine
60 2021-06-27 pain in extremity Patient states that arm has been sore to use since receiving the vaccine; NO redness, rash, warmth t... Read more
Patient states that arm has been sore to use since receiving the vaccine; NO redness, rash, warmth to touch or lump or swelling; she states it is sore upon waking in the morning and the stiffness lesses slightly as the day progresses but is sore all day sometimes she has issues gripping & moving arm front to back but not as much soreness raising arm upwards; she was advised by her prescriber to have pharmacy report
60 2021-06-28 tenderness Normal side effects at first. 72 hours after shot extreme pain in joints. Pain resolved everywhere b... Read more
Normal side effects at first. 72 hours after shot extreme pain in joints. Pain resolved everywhere but forearms, wrists, and hands. Currently, blood pooling in thumb joints, tenderness in wrists and fingers, stiffness in hands wrists, and forearms. Heat and sense of hardness in veins. Veins sticking out in forearms and thumbs. 13 weeks since vaccination. Primary Care physician unresponsive. Limited use of hands. Psychological despair setting in.
60 2021-06-30 pain in extremity, tenderness ACHY; CHILLS; TENDERNESS ON TOP OF THE HEAD; SORE ARM; This spontaneous report received from a patie... Read more
ACHY; CHILLS; TENDERNESS ON TOP OF THE HEAD; SORE ARM; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced tenderness on top of the head. On 18-JUN-2021, the subject experienced sore arm. On 19-JUN-2021, the subject experienced achy. On 19-JUN-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tenderness on top of the head on 21-JUN-2021, achy, and chills on JUN-2021, and sore arm on 26-JUN-2021. This report was non-serious.
60 2021-07-01 feeling of body temperature change FEELING WARM AND COLD; SEVERE CHILLS(EXTREME COLD); FEVER; MUSCLES PAIN; HEADACHE; This spontaneous ... Read more
FEELING WARM AND COLD; SEVERE CHILLS(EXTREME COLD); FEVER; MUSCLES PAIN; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was not reported and height was 66 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced feeling warm and cold. On 25-MAR-2021, the subject experienced severe chills (extreme cold). On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced muscles pain. On 25-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling warm and cold, severe chills(extreme cold), fever, muscles pain, and headache on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210663913.
60 2021-07-07 pain in extremity Initially pain in arm severe and last a few weeks 06/19/2021 got sick with diarrhea, sore throat, ea... Read more
Initially pain in arm severe and last a few weeks 06/19/2021 got sick with diarrhea, sore throat, earache, nausea felt like had the flu for several days was on a liquid diet of broth no medicines. 07/07/2021 started feel better with still scratchy though, no nausea or diarrhea.
60 2021-07-08 burning sensation, weakness, pain in extremity, nerve injury, coordination abnormal 4 months of new arm, shoulder and hand pain following vaccination with swelling and redness for 1mon... Read more
4 months of new arm, shoulder and hand pain following vaccination with swelling and redness for 1month. Entire shoulder girdle burns and aches. Strong inflammatory reaction started on first night with many varied reaction symptoms for 10 days. Arm and shoulder pain remained and got worse daily for months, I now have nerve damage, weakness and loss of function. MRI showed damage, tendonitis, tears and much more, pain was severe for first 7 weeks, then I lost my job, I could no longer type for 10 hours a day. The pain progressed to pronounced weakness and poor coordination. Difficult to sleep for 4 months now. A steroid injection given for chemical bursitis by an orthopedic doctor did not help. Physical therapy, acupuncture and a home TENS unit have helped, progress of injury healing and nerve enervation is very slow. High medical costs. Symptoms are similar to Parsonage Turner syndrome, but two doctors said shot was given incorrectly, low and too deep, so possible SIRVA, or both. I progressively worsened for 4 months, now I am in slow recovery but I fear it will go on for years. This has affected all areas of my life. It has been difficult to get medical care and to care for myself. I live alone, there are so many things I can no longer do. I was self-employed, now I have no income and have lost full use of my left arm.
60 2021-07-11 feeling hot At approximately the 30 minute mark, patient began complaining of hot and itchy palms. Palms and fin... Read more
At approximately the 30 minute mark, patient began complaining of hot and itchy palms. Palms and fingers developed redness and there were faint red areas bilaterally on both arms. Patient's PCP consulted and 25 mg of Benadryl was given. PCP saw patient and determined she was safe to go home.
60 2021-07-12 numbness 2 weeks after getting the vaccine I experienced a horrible headache that lasted 2 weeks. None of my ... Read more
2 weeks after getting the vaccine I experienced a horrible headache that lasted 2 weeks. None of my migraine meds worked on this headache. It was constant, for 2 weeks. It then started letting up, but I woke up with half my face being numb. It starts at my lips and moves up my face to my lower eye lid. My upper teeth are also numb on that side. The left side, When that happened I went to the ER as advised by my doctor (4-12-21). My blood pressure was very high so they treated me for that and did a CAT scan of my head and found nothing. I was sent home. Saw my Neurologist the next day 4-13-21, She ordered an MRI which was done on 4-17-21. Nothing significant was found. I also saw my Primary care doctor that same week. He did bloodwork to rule out auto immune diseases. Bloodwork was good. I also went to see my dentist that week to rule out dental problems. He did an xray and did not think it was dental related. The numbness is still there. It has not gone away
60 2021-07-13 pain in extremity, weakness VOMITING (WHEN SHE VOMITS, NOTHING COMES OUT); HAND SORENESS; FEVER; NAUSEA; HEADACHE (FEELS SHE CA... Read more
VOMITING (WHEN SHE VOMITS, NOTHING COMES OUT); HAND SORENESS; FEVER; NAUSEA; HEADACHE (FEELS SHE CAN SCREAM); WEAKNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: unknown) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced vomiting ( nothing comes out). On 09-JUL-2021, the subject experienced hand soreness. On 09-JUL-2021, the subject experienced fever. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced headache (feels she can scream). On 09-JUL-2021, the subject experienced weakness. Treatment medications included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, vomiting (nothing comes out), headache (feels she can scream), weakness and hand soreness was not reported. This report was non-serious.
60 2021-07-13 pain in extremity Strong headache and neck paon after two weeks of vaccination. Burning eyes. Leg pain. Difficulty to ... Read more
Strong headache and neck paon after two weeks of vaccination. Burning eyes. Leg pain. Difficulty to focus. Mind foggy. Tested for antibodoes for covid and vaccone resulted negatives after one month of vacconation and then again after 3 monthz. However had high autoinmune response. Headache and neck pain continued. Had N mri and neurologiat evaliation but nothing founf. Headaxhe continued and leg pain and stiffness also. Now also continuous ringing in my ears abd hot ears. Veins in my arm are unusually darker abd more visiblw.
60 2021-07-13 tremor My head hurt really bad shortly after injection and continued for at least 2 weeks, trouble with bo... Read more
My head hurt really bad shortly after injection and continued for at least 2 weeks, trouble with body shakes, also had trouble when taking walks with urinary isues, and exusted climbing stairs, caused pressure in my chest which is still there. Finally did Ultrasound of heart because of the pressure in chest, it came back ok. Having alot of junk in throat daily, constantly trying to clear it, I have to use fexofenadine daily instead of ocasional with Asthma flair ups., with shortness of breath it almost fells like emphysema, very sensetive to all smells worse then before.
60 2021-07-14 weakness The injection was given into the shoulder joint rather than the deltoid muscle. This has resulted in... Read more
The injection was given into the shoulder joint rather than the deltoid muscle. This has resulted in an inflammatory process that has caused pain and injury to my left shoulder (e.g., tendons, ligaments, bursae, nerves). I now have persistent shoulder and upper arm pain, weakness, and limited range of motion that has worsened in the two weeks following the injection. I am dealing with chronic shoulder and upper arm pain, and am unable to carry out daily activities that were not an issue prior to vaccination. When the symptoms did not subside, I sought medical treatment from my primary care provider on July 15, 2021.
60 2021-07-16 muscle spasms, feeling hot, discomfort LEFT EYE COVERED WITH VASELINE MUCOUS; DOUBLE VISION; FOGGY VISION/ EYE GLASSES DON'T WORK AS WELL F... Read more
LEFT EYE COVERED WITH VASELINE MUCOUS; DOUBLE VISION; FOGGY VISION/ EYE GLASSES DON'T WORK AS WELL FOR LEFT EYE; MUSCLE SPASMS; WATER RETENTION; DISCOMFORT; CRACKLES IN LUNG; SLEEP FOR LONGER THAN 2 TO 3 HOURS; WEIGHT GAIN; RIGHT FORE ARM BRUISE; BACK PAIN AND PRESSURE; BACK FREEZING UP; PAIN AT THE DIAPHRAGM; FELT SLEEPY; FELT REALLY HOT IN NECK; HEART BEATING REALLY FAST; FELT REALLY WEIRD; SWOLLEN AND RED FACE/ PUFFING UP LITTLE BIT; TROUBLE BREATHING; UNWELL FEELING (GROSS AND CRAPPY); ALLERGIC REACTION; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 150 pounds, and height was 64 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included caller stated that she does not have any chronic medical conditions. she takes 2-2.5 mg ativan daily, she stated this is half of the dose she was on 1 year ago. Patient had no any drug abuse/ illicit drug use. The patient experienced drug allergy when treated with medroxyprogesterone acetate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. Concomitant medications included diazepam, ketorolac tromethamine, and paracetamol. On 27-MAY-2021, the subject experienced felt sleepy. On 27-MAY-2021, the subject experienced felt really hot in neck. On 27-MAY-2021, the subject experienced heart beating really fast. On 27-MAY-2021, the subject experienced felt really weird. On 27-MAY-2021, the subject experienced swollen and red face/ puffing up little bit. On 27-MAY-2021, the subject experienced trouble breathing. On 27-MAY-2021, the subject experienced unwell feeling (gross and crappy). On 27-MAY-2021, the subject experienced allergic reaction. On 10-JUN-2021, the subject experienced back pain and pressure. On 10-JUN-2021, the subject experienced back freezing up. On 10-JUN-2021, the subject experienced pain at the diaphragm. Laboratory data included: CT scan (NR: not provided) Normal, Chest X-ray (NR: not provided) Normal, Laboratory test abnormal (NR: not provided) unknown, and Pain scale (NR: not provided) 9/10. On 08-JUL-2021, the subject experienced right fore arm bruise. On 09-JUL-2021, Laboratory data included: Spine X-ray (NR: not provided) could not find anything in the series. On an unspecified date, the subject experienced left eye covered with vaseline mucous, double vision, foggy vision/ eye glasses don't work as well for left eye, muscle spasms, water retention, discomfort, crackles in lung, sleep for longer than 2 to 3 hours, and weight gain. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 8-10/10, and Water retention (NR: not provided) gained 25 pounds. Treatment medications (dates unspecified) included: lorazepam, succinate sodium, methylprednisolone, methocarbamol, naproxen sodium, and methylprednisolone sodium succinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen and red face/ puffing up little bit, and trouble breathing on 27-MAY-2021, and left eye covered with vaseline mucous, double vision, and foggy vision/ eye glasses don't work as well for left eye, had not recovered from back pain and pressure, back freezing up, pain at the diaphragm, right fore arm bruise, water retention, and weight gain, and the outcome of felt sleepy, felt really hot in neck, heart beating really fast, felt really weird, unwell feeling (gross and crappy), crackles in lung, sleep for longer than 2 to 3 hours, allergic reaction, muscle spasms and discomfort was not reported. This report was non-serious.
60 2021-07-16 pain in extremity PAIN IN THE LEFT LEG; IMPROVEMENT FROM FIBROMYALGIA PAIN, MUSCLE ACHES AND PAIN WITH 80 TO 90% RELIE... Read more
PAIN IN THE LEFT LEG; IMPROVEMENT FROM FIBROMYALGIA PAIN, MUSCLE ACHES AND PAIN WITH 80 TO 90% RELIEF; SOAPY TASTE IN THE MOUTH; MILD NAUSEA WITH ON AND OFF; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood clot in the left leg at the age of 18, and concurrent conditions included asthma, fibromyalgia pain, muscle aches, and pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced soapy taste in the mouth. On 02-APR-2021, the subject experienced mild nausea with on and off. On 05-APR-2021, the subject experienced improvement from fibromyalgia pain, muscle aches and pain with 80 to 90% relief. On 06-APR-2021, the subject experienced pain in the left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the left leg on JUN-2021, and mild nausea with on and off, had not recovered from soapy taste in the mouth, and the outcome of improvement from fibromyalgia pain, muscle aches and pain with 80 to 90% relief was not reported. This report was non-serious.
60 2021-07-20 tingling, numbness CHEST X-RAY; ELECTROCARDIOGRAM; NUMBNESS IN RIGHT ARM; TINGLING IN RIGHT ARM; COMPUTERISED TOMOGRAM;... Read more
CHEST X-RAY; ELECTROCARDIOGRAM; NUMBNESS IN RIGHT ARM; TINGLING IN RIGHT ARM; COMPUTERISED TOMOGRAM; ULTRASOUND SCAN ABNORMAL; HYPERTENSION; SKIN SENSITISATION; ARTHRALGIA; PAIN; FATIGUE; PERIPHERAL SWELLING; DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; GAIT DISTURBANCE; FEELING ABNORMAL; DYSPNOEA; INFLUENZA LIKE ILLNESS; MALAISE; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (ID: 1331063) concerned a 60-year-old female. The patient's height, and weight were not reported. The patient's past medical history included degenerative disc disease (neck surgery (four discs repaired), and knee replacement, and concurrent conditions included fibromyalgia, and arthritis. The patient had no known allergy and current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAR-2021 15:00 at right arm for prophylactic vaccination. Concomitant medications included diclofenac, ibuprofen, oxycodone hydrochloride/paracetamol. The patient woke up and felt like she was hit by a train (feeling abnormal) and felt crappy for next 3-5 days, everything was hurting (malaise), even taking a step. She experienced gait disturbance, patient felt bad, tired like the flu (influenza like illness) but does not had respiratory issues. On 12-MAR-2021, she had dyspnea. Patient started symptoms shortness of breath, could not walk without SOB (Shortness of Breath), her legs started to swell (Peripheral swelling/edema), joints were sore/pain (arthralgia), she felt tired (fatigue). On 23-MAR-2021, she visited doctor with high blood pressure (hypertension) and edema, she was prescribed medication for blood pressure and fluid pills (unspecified). Four days later, her legs were swollen bigger, and the PCP switched the medication. It hurt to brush against the skin on her calf (skin sensitization). The patient was diagnosed 4 blood clots (thrombosis) in left calf by ultrasound scan. She ended up in the emergency room the following day, and Computerized tomogram scans were performed and they found pulmonary embolisms in the lower lobes of both lungs. The patient was also diagnosed with electrocardiogram, computerized tomogram, Blood test and chest x-ray. Laboratory data included: Computerized tomogram (NR: not provided) pulmonary embolisms in the lower lobes of both lungs, and Ultrasound scan (NR: not provided) 4 clot on left calf (abnormal). She has been taking Xarelto ever since. In JUN-2021, she said that she began feeling tingling numbness in her right arm, from her elbow to her fingertips. It tingles most of the day and wakes her up at night. Patient was on blood thinners. Laboratory data (dates unspecified) included: Blood test (NR: not provided) unspecified, Chest X-ray (NR: not provided) Not reported, and Electrocardiogram (NR: not provided) not reported. Treatment medications (dates unspecified) included: rivaroxaban. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from feeling abnormal, had not recovered from deep vein thrombosis, skin sensitization, peripheral swelling, pain, malaise, influenza like illness, hypertension, gait disturbance, fatigue, dyspnea, arthralgia, chest x-ray, computerized tomogram, electrocardiogram, and ultrasound scan abnormal, and the outcome of pulmonary embolism, numbness in right arm and tingling in right arm was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20210538232. Additional information was received from patient on 13-JUL-2021. The following information was updated and incorporated into the case narrative: reporter details (first and last name, address, city, zip code, office, email address), Updated disease start date (degenerative disc disease and knee replacement), Events added (pulmonary embolism, numbness in right arm and tingling in right arm), updated event (thrombosis to deep vein thrombosis), Updated event onset date (deep vein thrombosis, ultrasound scan and computerized tomogram) updated lab dates(ultrasound scan and computerized tomogram), updated lab result(computerized tomogram), Added vaccination time and treatment drug(Xarelto) and vaccine facility details (vaccine facility name, city and military information) Upon review following information was amended: Removed partial date (2021) of event Electrocardiogram and lab test (chest x-ray, electrocardiogram and blood test). Additional information was received from patient on 13-JUL-2021. It was determined that (20210538232) was a duplicate of this case. All relevant information regarding this case will be submitted under (20210556305); Sender's Comments: V1-20210556305-Covid-19 vaccine ad26.cov2.s-PULMONARY EMBOLISM and DEEP VEIN THROMBOSIS. Follow-up received regarding Other Information: reporter details, disease start date, Events added, updated event (thrombosis to deep vein thrombosis), event onset date ,lab dates,lab result, vaccination time , treatment drug and vaccine facility details . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210556305-covid-19 vaccine ad26.cov2.s-Thrombosis, ultrasound scan abnormal. This events are considered unassessable. The events has a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
60 2021-07-21 pain in extremity Sore upper left arm the day of vaccination. 20-26 hr after vaccination pain in left arm spread down ... Read more
Sore upper left arm the day of vaccination. 20-26 hr after vaccination pain in left arm spread down to the elbow and unable to lift using that arm. trouble sleeping the evening of 7/21/21 due to pain in arm. Extreme fatigue beginning 3pm day after vaccination. Unable to do any physical activity for more than about 5 min. then had to rest. So tired had to go to bed for the day at 8pm when normal bed time is 10-11pm
60 2021-07-22 inability to speak First 3 days - headache, nausea, body pain, chills, sweats,fatigue. About 3 weeks to present. Memor... Read more
First 3 days - headache, nausea, body pain, chills, sweats,fatigue. About 3 weeks to present. Memory loss, brain ?fog? Using the wrong word when speaking. ( not the word I was thinking ? , doing stupid things that I wouldn?t normally do , not thinking clearly. Forgetting where I?m going and what I?m doing with a long effort to recall where I am / what I?m doing.
60 2021-07-25 numbness, bell's palsy Bells Palsy, anti viral & steroid for one week. Mostly gone within a week. Lingering numb feeling in... Read more
Bells Palsy, anti viral & steroid for one week. Mostly gone within a week. Lingering numb feeling in cheek.
61 2021-03-05 feeling cold Mega headache (I get headaches so I know it was bad) about 3 hours afterwards. Really cold and falli... Read more
Mega headache (I get headaches so I know it was bad) about 3 hours afterwards. Really cold and falling asleep about 5 hours after. Next day generally just cold and body tired. No arm pain.
61 2021-03-05 hot flush, feeling cold, cold sweat, pain in extremity day 1 severe hot and cold flashes bad headache and severe arm pain today could not stand up sat do... Read more
day 1 severe hot and cold flashes bad headache and severe arm pain today could not stand up sat down felt Like I was going to pass out sat on floor bad cold sweats feeling nauseous bad diarrhea
61 2021-03-07 feeling hot Work up at 12:30 a.m. very hot and nauseous. When I tried to stand up I fainted. When I came to I... Read more
Work up at 12:30 a.m. very hot and nauseous. When I tried to stand up I fainted. When I came to I crawled to the bathroom and vomited several times. Continued to run fever for about an hour or so. Then headache began. As of 7:00 I still feel nauseous and have a slight headache.
61 2021-03-08 tremor, feeling cold -severe shaking / chills for 2 hours ...so much so that I could not get warm and my muscles hurt f... Read more
-severe shaking / chills for 2 hours ...so much so that I could not get warm and my muscles hurt from shaking so much -headache, body ache , both 24 hours -soreness at sight of injection
61 2021-03-09 flushing Received Janssen covid 19 vaccine 3/8/21 at 3PM. Twenty minutes after shot, felt skin flush pass ove... Read more
Received Janssen covid 19 vaccine 3/8/21 at 3PM. Twenty minutes after shot, felt skin flush pass over me and was directed to private area where paramedic took blood pressure and checked for hives. No hives but bumpy skin. Blood pressure spiked to 186/75. No history of such high blood pressure. Waited a while and blood pressure went down, flush and skin bumps subsided, and I went home. Blood pressure erratic in evening but never as high. Next day pulse higher than normal. Took homeopathic remedy. Pulse slowed down a bit. Better by next day.
61 2021-03-10 muscle twitching 4 pm injection 10 pm mind racing unable to sleep 10 pm body ache 2 (scale 0=none 10=worst pain) 11... Read more
4 pm injection 10 pm mind racing unable to sleep 10 pm body ache 2 (scale 0=none 10=worst pain) 11 pm body ache shine bone pain 4 2 am body pain 7 2 am chills 7 3 am uncontrollable leg twitching 10 4 am body pain, fever now twitching 10 7 am body pain, fever, twitching 10 (Still no sleep) 10 am body pain, fever 10 10 am leg twitching 7 12 (Noon) body pain, fever 8 12 leg twitching 4 3 pm body pain, fever 5 3 pm leg twitching 0 6 pm body pain, fever 2 10 pm body pain 1, fever 0
61 2021-03-11 feeling hot Patient reported prior to administration of vaccine significant history of syncope episodes with pre... Read more
Patient reported prior to administration of vaccine significant history of syncope episodes with previous vaccine injections. Placed in wheelchair prior to administration of vaccine. After vaccine given patient experienced lightheadedness and feeling hot within 1 to 2 minutes placed on cot no respiratory distress or anaphylaxis occurred symptoms persisted EMS on site now feeling better EMS recalled back to site and transported to local hospital.
61 2021-03-11 migraine 24 hours after receiving the vaccine I began experiencing adverse side effects that have continued t... Read more
24 hours after receiving the vaccine I began experiencing adverse side effects that have continued to last (Tuesday-Friday). I've experienced constant migraines, nausea, fatigue, diarrhea since Monday, all of which have caused difficulty with eating and sleeping.
61 2021-03-11 tremor Nausea first for 2 hours then fever that reached 101.9 at 12 hours after injection. Fever and aches... Read more
Nausea first for 2 hours then fever that reached 101.9 at 12 hours after injection. Fever and aches and shaking all night. Fever broke at 5:30 am-19.5 hours after injection. It?s 24 hours after injection and fever has broke but nausea has returned. Comes in waves. Extra tired and sick feeling just like the flu.
61 2021-03-12 tremor, cold sweat 3/13/21 03:00 am, chills, shakes 3/13/21 04:00 am, fever 102, threw up 3/13/21 07:00 am, dizziness, ... Read more
3/13/21 03:00 am, chills, shakes 3/13/21 04:00 am, fever 102, threw up 3/13/21 07:00 am, dizziness, cold sweats, nausea
61 2021-03-15 weakness Fatigue, tired, dizziness, palpitations, shallow breathing, lack of energy, diarrhea on 5th day afte... Read more
Fatigue, tired, dizziness, palpitations, shallow breathing, lack of energy, diarrhea on 5th day after the vaccine shot
61 2021-03-15 facial pain Diarhea nasua vomiting severe headsche pain in face
61 2021-03-15 pain in extremity Approximately 12 hours after injection I experienced extreme body aches. Hands ached, hips ached, ba... Read more
Approximately 12 hours after injection I experienced extreme body aches. Hands ached, hips ached, back aches, legs and feet ached. Hurt the balls of my feet when I walked. My eyes felt like they had sand paper in them. I did not run a fever but my body felt like I had. I had Flu B January of 2018, my syptoms after Janssen Shot were as severe as Flu B, but the duration was not as long! Approximately 24 hrs after injection I starting experiencing a headache, along with neck and shoulder aches. And I experienced fatigue for 3 days after injection along with the headache and neck, shoulder and back ache. On the fourth day following the injection I only feel tired. Aches, pains and headache are gone.
61 2021-03-16 weakness weakness, nausea, dry heaving, abdominal cramping and headache for a 2 day duration. Abdominal CT sh... Read more
weakness, nausea, dry heaving, abdominal cramping and headache for a 2 day duration. Abdominal CT showed 5 cm left adrenal mass consistent with acute adrenal hemorrhage. Platelets were 32,000 on admission. On the evening, the patient had a change in mental status; head CT revealed acute subarachnoid hemorrhage and small intraparenchymal hemorrhage.
61 2021-03-16 feeling hot, weakness Janssen COVID-19 Vaccine EUA; at 4:15 a.m. I took a tylenol for the headache I'd had since around 8... Read more
Janssen COVID-19 Vaccine EUA; at 4:15 a.m. I took a tylenol for the headache I'd had since around 8 pm; ate a few crackers with it; then as I was going back to bed I immediately felt weak/dizzy and then I passed out on the floor. My life partner started calling my name and check my pulse (which he said was strong) ; then I came to but was really dizzy; I was nauseous and vomited for a few minutes; extremely hot/sweating; and after I stopped vomiting, then had a bowel movement (He had to aid me in getting to the bathroom). About 20 - 25 minutes later I felt much better; everything calmed down. I was ultimately able to fall back to sleep.
61 2021-03-18 weakness, tremor DOSE AT 12:50 PM, ABOUT 5 PM GOT VERY NAUSEAND LAID DOWN IN BED ABOUT 8:00 PM, WITHIN MINUTES BECAME... Read more
DOSE AT 12:50 PM, ABOUT 5 PM GOT VERY NAUSEAND LAID DOWN IN BED ABOUT 8:00 PM, WITHIN MINUTES BECAME VERY VERY COLD. WAS VIOLENTLY SHAKING FROM CHILLS, THEN VIOLENT SHAKING WITH MUSCLE TENSION FOR SEVERAL SECONDS THEN RELAXED FOR A FEW MINUTES THEN MORE TENSION. ALL OF THIS ALONG WITH THE CHILLS.I DO NOT KNOW HOW LONG THIS HAPPENED BEFORE I FELL ASLEEP. NEXT DAY WAS VERY TIRED, AND ACHED ALL OVER AND WAS WEAK.
61 2021-03-20 weakness 30 minutes post vaccine injection I stood up and felt lightheaded, paramedic on site took my blood p... Read more
30 minutes post vaccine injection I stood up and felt lightheaded, paramedic on site took my blood pressure was 167/85, minutes later was 163/82. Ekg normal, blood sugar by finger stick 109, oxygen 98%. After 15 minutes BP improved to 137/73. While driving home I felt weak again unable to finish conversation. Walking from car mildly lightheaded, rested in bed. At 2:33 pm BP 105/58 heart rate 78, tired.
61 2021-03-20 weakness Lightheadedness/ feeling weak and faint
61 2021-03-21 feeling hot itching on forehead and neck, skin slightly pink. Both cheeks red and very warm to touch. began appr... Read more
itching on forehead and neck, skin slightly pink. Both cheeks red and very warm to touch. began approx 48 hrs after injection. The redness and heat on cheeks intensified through out the night and into the next day. Called my primary care doctor who recommended Zyrtec which eased symptoms. After 48 hours symptoms had mostly subsided.
61 2021-03-22 pain in extremity Chills, body/muscle aches, headache, sore arm
61 2021-03-28 tingling, pain in extremity Patient woke up the day after vaccination on 03/23/2021 with tingling feeling in arm. She felt as if... Read more
Patient woke up the day after vaccination on 03/23/2021 with tingling feeling in arm. She felt as if she slept on it wrong. On Thursday, 03/25/2021, her arm was still in pain and she spoke with her doctor. The doctor believed a nerve was hit during the administration of the vaccination. She was prescribed Ultram with a plan for follow-up in 1 week.
61 2021-03-29 tingling teeth-chattering chills, excruciating headache, 101 fever, muscle aches, vertigo, diarrhea, fatigue,... Read more
teeth-chattering chills, excruciating headache, 101 fever, muscle aches, vertigo, diarrhea, fatigue, achy chest with tingly cough, brain fog
61 2021-03-30 feeling hot Around 6 minutes post-vaccination, at 11:35, patient stated feeling a warm sensation radiating down ... Read more
Around 6 minutes post-vaccination, at 11:35, patient stated feeling a warm sensation radiating down both legs. After 10 minutes, around 11:45 the sensation had completely gone away. Patient reported no pain, dizziness, or nausea. Patient monitored for an additional 15 minutes, with no additional symptoms.
61 2021-03-31 tremor Chills causing physical shaking; vomiting three times including into next day
61 2021-04-01 migraine with aura prolonged Migraine with ora
61 2021-04-02 muscle spasms, muscle twitching, weakness Fever up to 99.7, chills, bodyache, muscle spasms or twitching in legs, weakness, head pain
61 2021-04-04 flushing 61 y/o female received Janssen vaccine @ 2:08 pm, while in the recovery area, @ 2:15 began to c/o fe... Read more
61 y/o female received Janssen vaccine @ 2:08 pm, while in the recovery area, @ 2:15 began to c/o feeling flushed and rapid heart rate. 2:15 pm vitals: 128/87, 115, O2 Sats 99% on RA, expressed feeling very anxious stating, "I have a hx of panic attacks". Patient instructed on deep breathing, and posturing to relax from very tensed positioning. 2:20 vitals: 120/103, 130, sats unchanged. Recovery Nurse worked w/patient to continue relaxed breathing, began to calm , HR down to 99 @ 2:25. Remained in recovery until 2:45 pm, last vital check, 112/84, 80 sats 99% RA, feeling more at ease, no further c/o rapid heart rate or feeling flushed, dc from recovery w/Son In Law who drive patient to appoint.
61 2021-04-04 pain in extremity, feeling cold RIB PAIN; VOMITING; HEADACHE; NAUSEA; INJECTION SITE PAIN; NIGHTMARES/VIVID DREAMS; FEELING COLD; FE... Read more
RIB PAIN; VOMITING; HEADACHE; NAUSEA; INJECTION SITE PAIN; NIGHTMARES/VIVID DREAMS; FEELING COLD; FEELS AWFUL; INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; ARM PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 175 pounds, and height was 161.29 centimeters. The patient's concurrent conditions included stroke, alcohol use 1-2 glasses per week, non smoker, depression, and sleeping problem. The patient experienced drug allergy when treated with povidone-iodine, and codeine for drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:30 in left arm for prophylactic vaccination. Concomitant medications included fluoxetine for depression, zolpidem for occasion sleeping problems, acetylsalicylic acid for stroke, and atorvastatin for stroke. On 12-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 12-MAR-2021, the subject experienced off label use. On 12-MAR-2021, the subject experienced arm pain. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. On 12-MAR-2021 18:30, the subject experienced feels awful. On 12-MAR-2021 19:00, the subject experienced feeling cold. On 13-MAR-2021, the subject experienced nightmares/vivid dreams. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced rib pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nightmares/vivid dreams, rib pain, vomiting, feels awful, feeling cold, arm pain, chills, fever, headache, nausea, injection site pain, and fatigue on 15-MAR-2021, and the outcome of off label use and inappropriate route of vaccine administration was not reported. This report was non-serious. Additional follow up information received on 26-Mar-2021.The following information was updated and incorporated into the case: age, medical history, demographics, concomitant medication, route of administration for suspect product, events (inappropriate route of vaccine administration and off label use) concomitant medications and outcome was updated.; Sender's Comments: V1: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
61 2021-04-05 pain in extremity very sore arm headache body aches chills low grade fever (100.3) All began approximately 12 hours af... Read more
very sore arm headache body aches chills low grade fever (100.3) All began approximately 12 hours after the vaccine was administered. As of this submission, it has only been approximately 16 hours since I received the vaccine. I am currently experiencing the listed symptoms. Given that, there is no information to provide for Item 21, below.
61 2021-04-06 weakness By 6pm, I started feeling feverish, with chills, nausea, chest pains and abdominal pain. I also expe... Read more
By 6pm, I started feeling feverish, with chills, nausea, chest pains and abdominal pain. I also experienced headaches and my fever got up to 102.5. I went to the ER and they gave me fluids. I was told it was a reaction to the vaccine, but my paperwork said upper respiratory infection. My cough started out dry, I had SOB, weakness, fatigue, diarrhea and joint pain. My PCP put me on a steroid and an antibiotic Keflex (500mg, 3 times a day). I get lightheaded just walking around the house. I'm still experiencing SOB, fatigue and the cough. Today is the first day that I could get up an move around. I'm fine when I first wake up, but I eventually feel depleted.
61 2021-04-07 tingling Severe - Chills for 12 hours, horrible neck/back pain, hallucinated, whole body ached & felt like I ... Read more
Severe - Chills for 12 hours, horrible neck/back pain, hallucinated, whole body ached & felt like I couldn't move, extremely tired, shortness of breath for 1/2 day, no energy, rash, runny nose & sore throat, tingly sensation on extremities (still occurring), ringing/piercing sound in my ears, headaches. It has been over 3 weeks and I still don't feel energetic & like myself.
61 2021-04-07 tremor shaking and chills, very high fever overnight, 4 degrees over my normal temp
61 2021-04-08 weakness Started after falling asleep. Was woken up by profuse sweating and then sleeplessness. Went to work ... Read more
Started after falling asleep. Was woken up by profuse sweating and then sleeplessness. Went to work and felt muscle aches and weakness all over. Then major exhaustion with a bad headache.
61 2021-04-09 weakness Mild tingling in tongue, felt "funny allover", itching, mild shortness of breath, difficult shallow... Read more
Mild tingling in tongue, felt "funny allover", itching, mild shortness of breath, difficult shallowing, hives, swelling in arm (right administered 75mg of Diphenhydramine oral 10 minutes apart, symptoms leveled out until assisting to restroom, needed assistance ambulating to and from toilet felt dizzy and weak, itching in arm became unbearable, itching all over became severe, administered patient's epipen, called EMS, patient was responsive when sent in ambulance to ER.
61 2021-04-09 weakness Very strong chills during the night, the next day weakness. Inappetence, excessive sleepiness, heada... Read more
Very strong chills during the night, the next day weakness. Inappetence, excessive sleepiness, headache. place of the vaccine inflamed with pain and itching it is been five days and it's still swollen and painful, from day 4 throat swelling with pain, place of the vaccine inflamed and pain. I have taken antiallergy, ibuprofen, cortisone cream in the place of the vaccine, and cold and hot
61 2021-04-09 feeling hot VOMITING; FEELS HOT; FEVER; DIARRHEA; COULDNT SLEEP; CHILLS; MUSCLE ACHES; NAUSEA; This spontaneous ... Read more
VOMITING; FEELS HOT; FEVER; DIARRHEA; COULDNT SLEEP; CHILLS; MUSCLE ACHES; NAUSEA; This spontaneous report received from a consumer concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced could not sleep. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced muscle aches. On 31-MAR-2021, the subject experienced nausea. On APR-2021, Laboratory data included: Body temperature (NR: not provided) under 100. On 01-APR-2021, the subject experienced vomiting. On 01-APR-2021, the subject experienced feels hot. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting, and nausea, had not recovered from muscle aches, chills, feels hot, and fever, and the outcome of diarrhea and could not sleep was not reported. This report was non-serious. Version created to amend previously reported information on 01-Apr-2021. Upon review the following information was amended: Event ranking updated and reporter type changed to consumer/ non health care professional from contact.
61 2021-04-09 numbness, tingling Immediate pain at injection, stinging sensation. Lasted for another 20 to 30 minutes off and on. Tin... Read more
Immediate pain at injection, stinging sensation. Lasted for another 20 to 30 minutes off and on. Tingling and numbness of right arm for short periods after shot off and on for about first 15-20 minutes. Slight dizziness for first 15 -20 minutes lasting short periods. Nausea, briefly twice in first 20 minutes. Light-headed for the duration of 30 minute wait-and-watch period. This was the most noticeable for me, besides the intense stinging sensation in my arm. After 30 minutes of being watched in common area, I stood up to leave with my adult children and my legs were wobbly. The nurses made me sit and stay a while longer and brought me a snack. I drank my water I had brought with me. Left after an additional 15 minutes.
61 2021-04-09 muscle twitching, numbness Forty minutes after the shot, my mouth, lips, neck, gums, and tongue became numb and I had difficult... Read more
Forty minutes after the shot, my mouth, lips, neck, gums, and tongue became numb and I had difficulty swallowing. This came on immediately. I started having shortness of breath and chest tightness. I acknowledge that the shortness of breath could have been due to panic, but the allergic reaction came first and was most definitely real. I also have muscle twitching on my left hand, which started after the shot. I've had it now for 28 hours. I got the shot on my left arm.
61 2021-04-09 pain in extremity CHILLS; ARM SORENESS; JOINT ACHE; LOW GRADE TEMPERATURE; SOME MUSCLE ACHE; SEVERE FATIGUE; This spon... Read more
CHILLS; ARM SORENESS; JOINT ACHE; LOW GRADE TEMPERATURE; SOME MUSCLE ACHE; SEVERE FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, and hypocholesteremia. The patient experienced drug allergy when treated with metaxalone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 around16:30 on right deltoid for prophylactic vaccination. Concomitant medications included ezetimibe/simvastatin for hypocholesteremia, and levothyroxine for hypothyroidism. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced arm soreness. On 30-MAR-2021, the subject experienced joint ache. On 30-MAR-2021, the subject experienced low grade temperature. On 30-MAR-2021, the subject experienced some muscle ache. On 30-MAR-2021, the subject experienced severe fatigue. Laboratory data included: Body temperature (NR: not provided) 99.5-100.5. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, arm soreness, joint ache, low grade temperature, some muscle ache, and severe fatigue on 31-MAR-2021. This report was non-serious.
61 2021-04-10 pain in extremity began feeling tired and slightly light headed a few hours after the vaccine. Developed a headache b... Read more
began feeling tired and slightly light headed a few hours after the vaccine. Developed a headache by evening same day(Day 1). Arm very sore. Day 2- still tired with light head and headache, arm very sore. Day 3- tired, light headed, headache, arm very sore. Day 4- tired, light headed, headache, sore arm. Day 5- pounding, splitting, incapacitating headache that required 800mg Motrin to start and 400mg every 5-6 hours, fatigue, light headed, sore arm, felt horrible.. Day 6- Woke up back to normal.
61 2021-04-10 pain in extremity At 4 AM the following day I woke up with a severe headache and fever. I attempted to take 2 extra st... Read more
At 4 AM the following day I woke up with a severe headache and fever. I attempted to take 2 extra strength Tylenol which seemed to trigger cyclic vomiting every 15-20 minutes for approximately 4 hours. After this, I vomited once an hour for another 4 hours. I was finally able to sip water and sleep after this. I also took my first temperature once feeling better and it was 99.9F. My normal temp is in the 97s and I?m sure it was much higher during the vomiting. My fever broke approximately 12 hours after the first symptoms. Headache lasted approximately 36 hours and resolved the next day, although a milder one did come back off and on for a couple more days. I did not have much pain in the arm I received the injection in.
61 2021-04-10 tingling on March 25 I had intermittent severe shooting pain at vaccine site. It lasted about an hour. Vacci... Read more
on March 25 I had intermittent severe shooting pain at vaccine site. It lasted about an hour. Vaccine site also felt very sore. Arm remained mildly sore but becoming slight more painful each day. with some tingling in fingers the following week. By April 10 muscle sore and painful to lift lift for shoulder adduction at 90 degrees.
61 2021-04-11 inability to speak, facial pain extreme pain on left side of face, throat, and neck. swelling in throat that caused fair amount of d... Read more
extreme pain on left side of face, throat, and neck. swelling in throat that caused fair amount of difficulty in breathing, talking and swallowing received epipen at urgent care on 04/09/2021 as the doctor felt I was having an allergic reaction to the covid vaccine and was told to go to the emergency room. was given IV of benedryl and pepcid. had a CT with contrast do to feeling of having something lodged in my throat. sent home with perscriptions for steroids and pepcid. still having symptoms though they are less severe
61 2021-04-11 weakness Burning immediately when the needle entered her arm before the vaccine was injected; difficulty rais... Read more
Burning immediately when the needle entered her arm before the vaccine was injected; difficulty raising her arm and opening the dishwasher since- loss of range of motion and weakness 1 week out.
61 2021-04-11 weakness mild headache, dizziness, nausea, and lack of energy six days after shot... Let's hope this won't ... Read more
mild headache, dizziness, nausea, and lack of energy six days after shot... Let's hope this won't last long.
61 2021-04-11 weakness Nausea, diarrhea, aches, fever 100. Weakness light headed, chills.
61 2021-04-11 burning sensation Pt had postmenopausal bleeding starting on 3/30-4/3. Workup with u/s was negative. Pt had burning ... Read more
Pt had postmenopausal bleeding starting on 3/30-4/3. Workup with u/s was negative. Pt had burning with bowel movement on 3/29, felt like a "habenero pepper." Also had itching and rash of chest wall, right breast, back. Received her shot in the left arm.
61 2021-04-11 feeling of body temperature change, flushing, tingling CHEST REDNESS; EYE ACHE; ELEVATED PULSE; DIZZINESS; DRY SKIN; EXCESSIVE THIRST; ITCHY RASH; HEADACHE... Read more
CHEST REDNESS; EYE ACHE; ELEVATED PULSE; DIZZINESS; DRY SKIN; EXCESSIVE THIRST; ITCHY RASH; HEADACHE; FACE FLUSH/ FACE WAS RED AND BUMPY; TOO HOT OR COLD/ INTERMITTENT FEELING EXTRA COLD(HEAD FEELS HOT AND REST OF BODY FEELS COLD); TINGLY FINGER; FELT LOUSY; BLOOD PRESSURE FLUCTUATION; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced blood pressure fluctuation. On 12-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 150/84 mmHg. On 15-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 125/85 mmHg. On 16-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/91 mmHg, 156/90 mmHg, 142/92 mmHg. On 17-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 137/88 mmHg, 140/92 mmHg. On 18-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 143/89 mmHg. On 23-MAR-2021, the subject experienced felt lousy. On 24-MAR-2021, the subject experienced tingly finger. On 27-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 156/96 mmHg. On an unspecified date, the subject experienced chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, headache, face flush/ face was red and bumpy, and too hot or cold/ intermittent feeling extra cold (head feels hot and rest of body feels cold). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure fluctuation, and the outcome of headache, chest redness, eye ache, elevated pulse, dizziness, dry skin, excessive thirst, itchy rash, face flush/ face was red and bumpy, too hot or cold/ intermittent feeling extra cold(head feels hot and rest of body feels cold), felt lousy and tingly finger was not reported. This report was non-serious. This case, from the same reporter is linked to 20210408073.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
61 2021-04-12 weakness Janssen COVID-19 Vaccine EUA About 1-1/2 hours after injection I became very light headed. I sat dow... Read more
Janssen COVID-19 Vaccine EUA About 1-1/2 hours after injection I became very light headed. I sat down for a couple of hours and it went away. That night I could not sleep. I only had about 3 hours of on-and-off sleep through the night. One time I woke up with severe chills The following day (Saturday) I had a lack of energy and in the afternoon I was running a low grade fever (99.8). Went to bed around 8:30 Saturday night, slept all night and felt fine Sunday morning.
61 2021-04-12 discomfort About 24-hours after getting the vaccination I started having pain and discomfort under my left arm.... Read more
About 24-hours after getting the vaccination I started having pain and discomfort under my left arm. I got the vaccine in my left arm. Feels like a swollen lymph node. A little more than 48 hours after the vaccine I am now starting to feel a little bit of pain and discomfort in my right underarm area lymph nodes.
61 2021-04-12 numbness, tingling, mild one side paralysis Patient complains of legs falling asleep at night which started about 7 days ago. Her hands have st... Read more
Patient complains of legs falling asleep at night which started about 7 days ago. Her hands have started almost falling asleep during the day hours the last couple of days. She is currently in between primary care physicians.
61 2021-04-12 pain in extremity, breast pain Severe headache lasting one day after the vaccine. On the second day @48 hrs strong underarm pain ra... Read more
Severe headache lasting one day after the vaccine. On the second day @48 hrs strong underarm pain radiating down under left breast, alleviated with Aleve every 12 hrs, lasted for over 1 week @8-9 days, actual bruising underarm pit, and pain and bruising down to the wrist and fingers. Did not seek medical attention.
61 2021-04-12 pain in extremity Approx 5 Minutes post vaccination : Severe Headache lasting approx 10 minutes, slight throat tighten... Read more
Approx 5 Minutes post vaccination : Severe Headache lasting approx 10 minutes, slight throat tightening, acceleration of heart rate that lasted about 15 minutes but continued intermittently for the first day post vaccination. Leg pain (aching) that lasted for 4 days. I struggled to think...as though I was in a fog ...for example it took me along time to think of an answer to a question I was asked. This lasted for 2 days. Severe tiredness 6 hours post vaccination, I slept for 2 hours then insomnia the first evening. Nausea beginning 6 hours post vaccination then rolling nausea that continued 6 days .
61 2021-04-12 pain in extremity Chills, muscle aches, fever of 102 for 6 hours from 2AM 3/9/2021-, fever of 101 and headache/ muscle... Read more
Chills, muscle aches, fever of 102 for 6 hours from 2AM 3/9/2021-, fever of 101 and headache/ muscle aches afterwards to 2AM 3/10/21 -fever broke. Fatigue, muscle aches continued for 3 days. (maybe not associated with vaccine... but hip/leg pain flared and continues as well as sudden fainting and flare of diverticulitis (ER-CTscan 3/28/21)
61 2021-04-12 pain in extremity Had flu-like symptoms night of shot. Fever and pain, plus arm pain. She thought shot was given rathe... Read more
Had flu-like symptoms night of shot. Fever and pain, plus arm pain. She thought shot was given rather high on shoulder.
61 2021-04-12 pain in extremity Had injection on March 31, 2021. Very sore arm with soreness and stiffness in the neck for a few day... Read more
Had injection on March 31, 2021. Very sore arm with soreness and stiffness in the neck for a few days. On April 8th woke up very dizzy, had to lay back down for a little bit. On April 10th woke up not being able to take a deep breath without a very bad pain in my back (it felt like my right lung) same issue the 11th, and 12th. This pain was not severe unless I took a deep breath. I was able to go about my daily activities. Today April 13th still a little tight in my lung but do not have the pain in my back that I had the last few days.
61 2021-04-12 pain in extremity Day 3 - Chills, Thirsty, Tired Day 10 - Day 3 through 10 fatigue, with the worse being day 10. Sligh... Read more
Day 3 - Chills, Thirsty, Tired Day 10 - Day 3 through 10 fatigue, with the worse being day 10. Slight headache, slight leg, thigh, shin pain after short walk. Still tired, with slight weakness 3 weeks after vaccine.
61 2021-04-12 pain in extremity It has been a month since getting the vaccine and my arm is still painful to the point of limited mo... Read more
It has been a month since getting the vaccine and my arm is still painful to the point of limited movement. The first few days after the shot, I was not concerned about the soreness, I knew it was a normal side affect. But at this point I am more concerned and do feel it is an issue to be reported. This may keep me from getting the vaccine in the future.
61 2021-04-12 tingling, discomfort Immediately after shot I felt pressure all over my body and my face tingled. The pressure eased off ... Read more
Immediately after shot I felt pressure all over my body and my face tingled. The pressure eased off quickly but the tingling lasted until the next day then my face felt like I had been punched. I still have a little face swelling and itching with raised red spots on my face that move around to this day.
61 2021-04-12 cold extremities Beginning approximately 10 PM (about 8 hours post-injection), I started to have chills (feet were fr... Read more
Beginning approximately 10 PM (about 8 hours post-injection), I started to have chills (feet were freezing) and was exhausted. Went to bed, and slept most of the night, only waking once to urinate and to drink a small amount (approx 2 oz) of Coca Cola -- I was very nauseous and thought it would help settle my stomach. During the night I sweated profusely. At 8 AM, I woke again and went to urinate. At that time I felt very nauseous, dizzy, and light headed. When I walked about 2 -3 feet to my bedroom, I collapsed on the floor - unconscious. My partner called EMS, they arrived minutes later. By then I was conscious. They transported me to Medical Center Emergency Room, where I remained for several hours. They indicated that my SYNCOPE was a result of dehydration. TODAY, 4/13, news of BLOOD CLOTS has compelled me to report my adverse reaction.
61 2021-04-13 weakness Whether the adverse events were caused by the vaccine is to be determined. We are available to disc... Read more
Whether the adverse events were caused by the vaccine is to be determined. We are available to discuss more details if this information can be used to help others from experiencing these reactions. The morning after getting the vaccine, patient discovered that she could not swallow. As her condition worsened, she was taken to the emergency room. Over the past month, patient went to the emergency room 4 times. The last time resulted in extended hospitalization that continues to this day. In addition to the swallowing problem, two other major adverse events need to highlighted. First, on 27 March, while in the hospital, vaginal bleeding started. On 29 March, her doctor, performed a hysteriscopy/DNC finding " "an unexplained blood clot (hematoma)." The second major event was when patient demonstrated significant confusion and lack of memory. On 7 April, she was diagnosed with Metabolic Encephalopathy. Neurologists at the hospital suspected that her MS was reacting to her UTI and once the infection is eliminated her memory should come back. But as of 10 April, she was still having issues including hallucinations. Although she is eating some as of 13 April, she is still very weak and will likely by moved from the Hospital to a rehab facility. She still does not remember much of the last 37 days.
61 2021-04-13 feeling cold, pain in extremity 3/29/21 6 pm - Severe pain lower right leg, ankle, and foot, unable to weight bear on right leg Abou... Read more
3/29/21 6 pm - Severe pain lower right leg, ankle, and foot, unable to weight bear on right leg About an hour later I was able to walk a little. Stayed off my feet. Right foot became very cold. 3/30/21 Saw my primary care physician at med center. She sent me for an ultrasound at medical arts. From there I was sent to the emergency room at hospital. I asked the attending physician assistant about a correlation between the blood clot and the Covid vaccine because I had read about it being a concern in other countries. He stated that was a bunch of baloney. Was told to have a repeat ultrasound in a few days and was prescribed a 30 day starter pack of Xarelto and released. 3/30 repeat penis ultrasound of right leg showed the same results. 4/1 appointment with hematologist. Prescribe Xarelto for three months and ordered a repeat ultrasound in three months and bloodwork at that time.
61 2021-04-13 feeling cold Nothing very serious. Cold chills, mild headache, some back and muscle pain, fogginess. All side eff... Read more
Nothing very serious. Cold chills, mild headache, some back and muscle pain, fogginess. All side effects were completely gone within 30 hours after onset.
61 2021-04-13 feeling of body temperature change, pain in extremity, tremor Right after shot, did not feel anything that morning till around 5pm I started to feel feverish, hea... Read more
Right after shot, did not feel anything that morning till around 5pm I started to feel feverish, headache, tired. My arm never got sore or swollen. AFter 5pm till, the feverish feeling and hot cold got worse as time went by and I started shaking uncontrollably - pretty severe. I took Tylenol early hoping to stop the achy feverish and shaking but did not seem to help. THis went to till about 1am or 2am when I could finally lay down and try to sleep. The shaking had stopped. I did take more Tylenol and drank some herbal chamole type of hot tea. I could not sleep that night. Next day I was exhausted, body aches and still had some feverish feeling. By the way, took my temperature and it was normal. Then on Wednesday, I believe is when I had a huge episode of diarrhea (came on sudden). I kept calling and talking virtually to the doctor telling him all of what was going on. The next day I the feverish feeling and body aches and being tired kept happening - adding headache getting worse. I kept taking Tylenol. Seem to help some but did not take the pain away. EAch night , I could not sleep due to the headache. I started to feel better but then on the weekend, I had that headache and tired feeling. The headache was getting stronger and it circled my whole head and both shoulder and around my neck. It scared me because I felt at times that my throat was getting smaller. I could still swallow but it was so strange. I kept putting heat packs and ice packs and taking Tyelnol. I know that on Thursday or Friday the week, the doctor told me if I wanted to to go get tested for Covid and I did. I was tested negative on both the quick test and the other test that takes longer. I had that headache, sinus tension pressure for quite a few more days. Overall it took 7 days. I had to take off most of the week from my telework job because I could not function. I also did not eat much and drank lots of water during this time. It seem to go away and then about a week later, I got this painful diarrhea out of the blue and went to see an urgent care doctor. They tested me for blood, urine, and stool and they were negative. I was also having pain on my left side. Then it seem to go away after I was on the BRAT diet for a few more days. Then the diarrhea happened again the next week or so. This week, as of yesterday, I got a very strange throbbing pain in my left hand and not sure where that came from. It can be extreme at times. I tool Tyleonol but the pain is still there. Also, during this time and before the shot, I got a trigger finger issue on my right index finger. I don't think that has anything to do with the vaccine. Please note I have been told my doctors and I know this for a fact, my body is super sensitive to food, meds. I don't usually get the flu shot because of that. Today I am experiencing the left hand pain and now metal tasting in my mouth. I am about 5 weeks out from the vaccine. I wish I had never taken it. I pray nothing more will happen in my body If I have left anything off it is because I did not write this down when was happening. I really thought I was going to die one night because of the pressure I was having in my head, neck and shoulders. I have a little bit of a headache now and told my PT doctor that if I needed to know, I could get a brain or some kind of scan to see if I am hainvg any issues. I am going to bring this up to my virtual call today.
61 2021-04-13 flushing 4/12/21 12:30 pm began to feel fatigued, face felt flushed. No fever. Fatigue increased more in the ... Read more
4/12/21 12:30 pm began to feel fatigued, face felt flushed. No fever. Fatigue increased more in the evening. 4/13/21 2:30 am awoke and found entire face swollen and slight tingle in lips. Took Loratadine, Metoprolol and Triamterene/HCTZ and went back to bed. Awoke at 5 am, swelling better, but not gone. Still very puffy above and below eyes. Felt fatigue, no fever, went to work. Felt better by lunch time, swelling almost gone. 4/14/21 Slight sore throat, slight fatigue, no swelling.
61 2021-04-13 mild one side paralysis Stroke- hearing loss in right ear, extreme headache left temple lobe, nausea, dizziness, diarrhea, i... Read more
Stroke- hearing loss in right ear, extreme headache left temple lobe, nausea, dizziness, diarrhea, inability to move legs. Hospitalized for 5 days Continued weakness left side of the body
61 2021-04-13 numbness, tingling She got the vaccine and immediately she had brain fever that came on immediately, her brain feels li... Read more
She got the vaccine and immediately she had brain fever that came on immediately, her brain feels like it is swollen and nothing she does help it. She has an extreme splitting headache to where she feels her brain is going to go out of her head. She has also had numbness and tingling down the right side of her body and into her tongue. She cannot get to feeling better, she just keeps feeling worse. She has taken Tylenol/Ibuprofen, and dr. put her on prednisone and gave her a Z-PA to see if this will alleviate symptoms. Nothing she has taken has helped with it. She feels as though her brain is swollen and that she going down hill. She is a cancer survivor and cannot determine if having that has made her worse. The pressure has gone to her ears, feels like it is going to burn her ear drums up. She also has tinnitus with it as well. She also has tinnitus and the headache that will not go away. She has called her doctor many times and hasn't gotten any results back.
61 2021-04-13 numbness Patient reporting numbness in both arms and legs which began 4 days ago (4/10/2021). Numbness comes ... Read more
Patient reporting numbness in both arms and legs which began 4 days ago (4/10/2021). Numbness comes and goes and increases in intensity throughout the day. Patient also reports extreme fatigue and headaches that have not resolved since vaccination date (4/5/2021).
61 2021-04-13 pain in extremity Severe headache, Chills, 100.2 fever, body aches, Headache lasting several hours High fever lasting ... Read more
Severe headache, Chills, 100.2 fever, body aches, Headache lasting several hours High fever lasting 1 hour Chills lasting 2 hours body aches continue as well as right leg pain 5 days after shot, lasting 3 days. Called doctor, prescribed ibuprofen
61 2021-04-13 tingling, numbness On 4/6/21 morning, standing helping sick Dad to shower, I experienced dizzy spell and felt like I wa... Read more
On 4/6/21 morning, standing helping sick Dad to shower, I experienced dizzy spell and felt like I was leaning to the left side. Slow to regain balance. Lightheaded after for an hour or so. On 4/9/21 evening, while sitting, I felt my head fog up, my left eye spinning in the bottom, my left arm went numb and fingers tingled, left leg numb (1st episode). Lasted several minutes. Shortly after, I experienced another like the first, Tried to walk to the other room, felt like I was dragging my left leg and left arm. Lasted several minutes. Took baby asprin, Within the hour I had 2 more milder episodes. Reported to my doctor on Sunday. She is scheduling tests for me today.
61 2021-04-13 tingling, numbness Within 30 minutes the patient had numbness and tingling in the left arm down to her hand. This feel... Read more
Within 30 minutes the patient had numbness and tingling in the left arm down to her hand. This feeling progressed to numbness and tingling up into the left side of her face. No redness or swelling anywhere. These paresthesias have persisted for 1 week so far.
61 2021-04-13 unresponsive to stimuli Patient experience flu like symptoms and body aches the same evening after receiving vaccine. On 4/... Read more
Patient experience flu like symptoms and body aches the same evening after receiving vaccine. On 4/1/21 the patient experienced nausea, high blood pressure, and a headache. Around 7:00 pm that night the patient threw up and became unresponsive. The patient was then transported to the hospital by ambulance. A CT scan showed a brain bleed and the patient was intubated and transferred to another hospital.
61 2021-04-14 numbness, tremor, seizure, pain in extremity right after the vaccine in the pharmacy my throat felt like it was closing. and medicine taste going... Read more
right after the vaccine in the pharmacy my throat felt like it was closing. and medicine taste going down my throat , pharmacist said no big deal. I went home 4 hours later i had fever and shakes and convulsions and my right finger were numb and my right leg and right low side hurt. My neighbor call the pharmacy and they said its normal to work thru. april6 pain in side was unbearable and i went to the doctor. had a ct scan and they put me on antibiotics.I had had headache for 15 days now. I don?t know how i am going to pay mymedica bill for a free covid vaccine.
61 2021-04-14 migraine Intermittent 102° fever with normal temperature of 97.7° three days in a row, cold sore on mouth, ... Read more
Intermittent 102° fever with normal temperature of 97.7° three days in a row, cold sore on mouth, migraine, body aches, chills, insomnia.
61 2021-04-14 muscle spasms vaccine reaction-passed out. c/o worsening headache and feels tire. states broke out sweat, stomac... Read more
vaccine reaction-passed out. c/o worsening headache and feels tire. states broke out sweat, stomach pain, HA, leg cramping and passed out (for about 30sec according to husband) on Mon. took Advil several days. last Advil 0600. J&J vaccine on 5 Apr. 61 yo f w/spouse c/o ongoing headache w/concerns for single episode of 'passing out' approx 48hrs pta approx 30-45 sec per spouse at bedside; Pt states nighttime episode w/preceding leg crampings, sweating, dizziness, sat on footstool and per spouse passed out but caught by spouse and avoided injury; spontaneous recovery w/o further issue from that episode, spouse denies any post-syncope seizure-like activity/urinary incontinence/tongue biting; Pt and spouse concerned. for cerebral venous thrombosis; Pt has sig hx of prior neurosurgery for posterior/occipital schwannoma around 2017, successfully removed, w/o further findings or complications on f/u (last DEC 2020) to include repeat imaging at that time Pt states has been taking advil OTC for ha but no sig relief at this time; Pt defers need for medications at time of provider evaluation; Pt denies any fevers/ns/chills, cp, sob, palpitations, dyspnea, abd pain/cramping, current nvd, prior syncope, fam hx of MI/SCD/dysrhythmias.
61 2021-04-14 pain in extremity Leg pain.
61 2021-04-14 pain in extremity Patient received vaccination without noted reaction. On 04/10/2021 patient was transported to hospit... Read more
Patient received vaccination without noted reaction. On 04/10/2021 patient was transported to hospital via ambulance c/o shortness of breath. Patient was diagnosed with pneumonia. Patient refused admission and returned home with prescriptions for inhalers, steroids, and antibiotics. Patient claims on 02 at home prior to event. Patient also c/o left leg pain (unspecified) but has not sought medical care. Patient treated at Hospital. Patient was advised to follow with her PCP for leg pain.
61 2021-04-14 pain in extremity My arm was very sore and 3 weeks later my left arm is STILL very tender at injection site. I was ver... Read more
My arm was very sore and 3 weeks later my left arm is STILL very tender at injection site. I was very tired for about a week w ? brain fog? very scattered pertaining to staying on task. I see a neurologist in for headaches and administers Botox for that. I am concerned if I get a headache from the vaccine the Botox will mask it. I did have a bad headache yesterday which is unusual given I get Botox for headaches
61 2021-04-14 cold extremities Symptoms occurred 12 hours after shot - approx 2 am. Chills all over body - hands freezing, body ac... Read more
Symptoms occurred 12 hours after shot - approx 2 am. Chills all over body - hands freezing, body aches- whole body, heart racing. After approx 6 hours - developed additional symptoms of a headache - location was back of head and severe teeth and jaw pain on right side of face. Unable to sleep all night. At noon - got up and read vaccine literature to see if I could take anything for the pain. Took Extra Strength Tylenol - 2 00 mg gel caps . Stayed awake for a 1/2 - pain in teeth, jaw and head got got better. Went back to bed for 4 hours. When work up later in the afternoon - felt okay.
61 2021-04-15 weakness, hot flush, feeling of insects crawling on skin Intense pain, hot from injection site, down entire arm immediately after given. Continued pain afte... Read more
Intense pain, hot from injection site, down entire arm immediately after given. Continued pain after two days into two weeks, shooting pains , crawling at injection site,and throbbing, even at elbow and wrist. Arm was also very weak, and still gets tired and throbs . Has been 4 weeks this week-end . Reported to nurse who tod me to see my Dr. which I did this week. No redness at injection site, just soreness, know something was off, according to side effects. Very tired feeling, still, and had some flushed color the first week in my face and like heat flashes for two weeks. Hope to get the normal feeling back in my arm. Not sure ? Maybe a nerve was nicked? But was not like a Bee Sting like tech described it would feel like that day. Had a ruff start.
61 2021-04-15 weakness, pain in extremity, tremor SHAKING TO THE BONE; RADIATING MUSCLE PAIN; LOW GRADE FEVER; ARM BRUISED FROM INSIDE; DISCOMFORT UNP... Read more
SHAKING TO THE BONE; RADIATING MUSCLE PAIN; LOW GRADE FEVER; ARM BRUISED FROM INSIDE; DISCOMFORT UNPTO THE SHOULDER; STOMACH PAIN; ARM HURTS ALL THE TIME; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced arm bruised from inside. On MAR-2021, the subject experienced discomfort up to the shoulder. On MAR-2021, the subject experienced stomach pain. On MAR-2021, the subject experienced arm hurts all the time. On MAR-2021, the subject experienced loss of energy. On 23-MAR-2021, the subject experienced shaking to the bone. On 23-MAR-2021, the subject experienced radiating muscle pain. On 23-MAR-2021, the subject experienced low grade fever. The patient recovered from arm bruised from inside, discomfort up to the shoulder, shaking to the bone, stomach pain, loss of energy, and low grade fever on MAR-2021, and had not recovered from arm hurts all the time, and radiating muscle pain. This report was non-serious.
61 2021-04-15 weakness, pain in extremity CHILLS; LOSS OF APPETITE; DIZZINESS; TIREDNESS; MUSCLE ACHE; WEAKNESS; PAIN IN ARM; VOMITING; NAUSEA... Read more
CHILLS; LOSS OF APPETITE; DIZZINESS; TIREDNESS; MUSCLE ACHE; WEAKNESS; PAIN IN ARM; VOMITING; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the patient experienced nausea, fever. On 10-APR-2021 the patient experienced tiredness, weakness, muscle ache, vomiting, dizziness, pain in arm. On 11-APR-2021, the patient experienced loss of appetite and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 10-APR-2021, and dizziness on 11-APR-2021, was recovering from nausea, and pain in arm, and had not recovered from fever, weakness, muscle ache, loss of appetite, chills, and tiredness. This report was non-serious.
61 2021-04-15 feeling cold FEELING COLD; DIZZINESS; BODY ACHES; TIREDNESS; HEADACHES; This spontaneous report received from a p... Read more
FEELING COLD; DIZZINESS; BODY ACHES; TIREDNESS; HEADACHES; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not have any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced feeling cold. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling cold, and dizziness, and had not recovered from body aches, tiredness, and headaches. This report was non-serious.
61 2021-04-15 numbness, tingling, feeling cold Progress Notes - Clinical MD at 4/15/2021 1:30 PM HPI: 61 year old female with IBS presents wi... Read more
Progress Notes - Clinical MD at 4/15/2021 1:30 PM HPI: 61 year old female with IBS presents with concerns about adverse reactions to vaccine which she got on 3/19/21. Patient reports that she felt lightheaded after the vaccine when she was leaving. She got home and felt better but then that night woke up in a delirium which passed by the morning. She had some weakness in her extremities, brain fog, cold feeling, funny GI feeling and fatigue for 3 days and then was fine. Two weeks ago she started to feel that the circulation in her lower legs was cut off with sensation of blood pooling in her legs with associated numbness and tingling. She describes it as what you feel when a tourniquet is applied to your arm. No visible lower extremity swelling, redness and no pain. One week ago she felt like her right hand was not working well and then left hand too. She then felt pooling in her arms like the sensation in her legs.No swelling, redness or pain. She reports she did a hand stand and afterward felt pooling sensation in her lower abdomen which has since resolved but continues to have a prickling sensation that comes and goes. Last night while lying on her back she felt the pooling sensation in her chest and this morning throbbing in head and chest and neck. That is when she decided to come in and be seen. Patient denies severe headache, backache, abdominal pain, shortness of breath, bruises, unusual bleeding or rashes. Patient has not had a physical exam with blood work since 11/9/17.
61 2021-04-15 muscle spasms NECK SORE TO TOUCH; EXCRUCIATING BACK PAIN; COULD NOT LIE ON BACK AND ON SIDE; MILD BODY ACHES; BACK... Read more
NECK SORE TO TOUCH; EXCRUCIATING BACK PAIN; COULD NOT LIE ON BACK AND ON SIDE; MILD BODY ACHES; BACK PAIN RADIATING TO ABDOMEN; CHILLS BECAME WORSE; HEADACHE; MILD TEMPERATURE; CAHRLIE HORSE IN NECK, SHOULDERS. AND LEGS; DIARRHEA; SLEEPY; STOMACH PAIN; LOSS OF APPETITE; FELT TIRED; DRY COUGH; COULD BARELY WALK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced could barely walk. On 2021, the subject experienced dry cough. On 28-MAR-2021, the subject experienced loss of appetite. On 28-MAR-2021, the subject experienced felt tired. On 29-MAR-2021, the subject experienced stomach pain. On 30-MAR-2021, the subject experienced sleepy. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced cahrlie horse in neck, shoulders; and legs. On APR-2021, the subject experienced mild body aches. On APR-2021, the subject experienced back pain radiating to abdomen. On APR-2021, the subject experienced chills became worse. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced mild temperature. On 01-APR-2021, the subject experienced excruciating back pain. On 01-APR-2021, the subject experienced could not lie on back and on side. On 02-APR-2021, the subject experienced neck sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciating back pain, and could not lie on back and on side on 08-APR-2021, and cahrlie horse in neck, shoulders. and legs on 01-APR-2021, was recovering from diarrhea, loss of appetite, neck sore to touch, and mild temperature, had not recovered from felt tired, sleepy, headache, mild body aches, stomach pain, and chills became worse, and the outcome of dry cough, back pain radiating to abdomen and could barely walk was not reported. This report was non-serious.
61 2021-04-15 pain in extremity ZAPPING PAIN THROUGH LEGS AND SHOULDERS; CHILLS; LEGS BURNING AND ACHY; SORE JOINTS; This spontaneou... Read more
ZAPPING PAIN THROUGH LEGS AND SHOULDERS; CHILLS; LEGS BURNING AND ACHY; SORE JOINTS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced zapping pain through legs and shoulders. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced legs burning and achy. On 08-APR-2021, the subject experienced sore joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, legs burning and achy, sore joints and zapping pain through legs and shoulders was not reported. This report was non-serious. This parent/child case is linked to 20210420242.
61 2021-04-16 speech disorder, inability to speak Presented as a TIA (mini stroke) Had vision issues, difficulty speaking, vertigo, could not walk, p... Read more
Presented as a TIA (mini stroke) Had vision issues, difficulty speaking, vertigo, could not walk, passed out and taken to hospital by ambulance . Began at around 10am. Felt like I was dying. Placed on Stroke Unit. Scans and tests all negative for stroke and Drs. thought could be panic attack or TIA. Since then my lingering effects point to TIA, Seemed to clear up around 2pm with gradual improvement through the day. Still experiencing some side effects including tinnitus, memory and word retrieval issues, fatigue, anxiety. DO NOT HAVE PANIC ATTACKS. The only time I have had a panic attack was at 26 after the death of my mother.
61 2021-04-16 unresponsive to stimuli My sister, received the J & J vaccine on March 5th. I now know that she was not feeling well for a ... Read more
My sister, received the J & J vaccine on March 5th. I now know that she was not feeling well for a few days afterwards. She then felt better until day nine after the vaccine. On the evening of the ninth day, she began having abdominal pain, vomiting & diarrhea, headache. This was Sunday evening. Unfortunately I wasn?t aware of how she was feeling and she didn?t go to the emergency rm. until Tuesday morning. Tests determined her platelet level was low and abdominal CT showed bleeding from her adrenal glands. She was given platelets, pain meds and admitted into the hospital. Later that night staff felt she wasn?t responsive and a head CT was performed. It was determined she had a brain hemorrhage and emergency surgery was performed. It is my understanding that there was brain damage at that point. During the early morning hours of the 10th day, post surgery, a repeat CT scan was done showing more hemorrhaging and blood clots. She also developed a DVT and PE and was kept on a respirator until the 13th day post vaccine to allow family to say their goodbyes. On the morning of the 13th day patient was removed from life support and she passed.
61 2021-04-17 tingling, numbness The left hand and foot developed bruising spontaneously at 2 pm, finger went numb and white., with t... Read more
The left hand and foot developed bruising spontaneously at 2 pm, finger went numb and white., with tingling. Skin on hands reddened. These symptoms continue today, the day after, though lessened. Hands remain tingly and redness of skin is ongoing.
61 2021-04-17 tremor COUGH; SHAKES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a ... Read more
COUGH; SHAKES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25/MAY/2021) .5 ml, administered on 07-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced cough. On 08-MAR-2021, the subject experienced shakes. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, shakes, fever, cough, and headache. This report was non-serious.
61 2021-04-18 weakness, numbness, tingling TINGLING AND BURNING SENSATION IN FEET; WEAK IN THE BODY; TIRED IN THE BODY; FEELING NUMB IN THE HAN... Read more
TINGLING AND BURNING SENSATION IN FEET; WEAK IN THE BODY; TIRED IN THE BODY; FEELING NUMB IN THE HANDS; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced feeling numb in the hands. On 05-APR-2021, the subject experienced tired in the body. On 08-APR-2021, the subject experienced tingling and burning sensation in feet. On 08-APR-2021, the subject experienced weak in the body. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tired in the body, and feeling numb in the hands, and had not recovered from tingling and burning sensation in feet, and weak in the body. This report was non-serious.
61 2021-04-18 feeling cold Chills, severe body aches, coughing, spitting up phlegm, feeling cold, couldn?t get in my inhalers, ... Read more
Chills, severe body aches, coughing, spitting up phlegm, feeling cold, couldn?t get in my inhalers, couldn?t breathe good, call my doctor office ( lung & disease) was advise to go the hospital, lasting 2 weeks, took back to back nebulizer treatments, cough medication.
61 2021-04-18 pain in extremity Continual ongoing headaches, extreme body aches particularly in shoulder & neck
61 2021-04-19 numbness, pain in extremity "Pressure on the chest/ pinching feeling up to my back. My left arm goes numb on and off with a lit... Read more
"Pressure on the chest/ pinching feeling up to my back. My left arm goes numb on and off with a little pain. Headache and dizziness. Vaccine given in the right arm."
61 2021-04-19 numbness Numbness/pain on the left side of the upper body
61 2021-04-19 pain in extremity, discomfort On 3/21/2021 I woke up with sudden bad left lower back pain that radiated down the lateral left thig... Read more
On 3/21/2021 I woke up with sudden bad left lower back pain that radiated down the lateral left thigh. It continued to get worse as the week wore on. I could not bend over, lie down or sit for very long without severe discomfort. I ended up seeing a chiropractor within the week who has been treating the problem over this past month. X rays were taken. I have been treating it with ice, ibuprofen, and aspirin.
61 2021-04-19 pain in extremity Bone and muscular pain in legs
61 2021-04-19 tingling, numbness, cold extremities Sudden onset of bruise in left ring finger and on left foot, left of big toe, both appeared at once ... Read more
Sudden onset of bruise in left ring finger and on left foot, left of big toe, both appeared at once while eating lunch. Left ring finger went numb, white and cold, with bruise appearing on the middle digit. Other finger tips turned pink. Skin turned red onhands with tingling sentation. Right hand blood vessels came to the surface and began to swell at intersections. Skin on rt. hand looked whiter and dry. The sudden onset sent me to the emergency room, the condition began to fade in 3 hours, not completely. The same reaction occured the next day at 12 noon. I took a hot shower and the condition improved followed by extreme tiredness. *At the time of vaccination, & on both of these events I had a stiff neck/red skin.
61 2021-04-19 tingling DRY MOUTH; TINGLING IN HANDS; HEADACHE; NAUSEA; INCREASED FATIGUE; This spontaneous report received ... Read more
DRY MOUTH; TINGLING IN HANDS; HEADACHE; NAUSEA; INCREASED FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroidectomy, and concurrent conditions included breast carcinoma, and teeth problems. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced dry mouth. On 17-MAR-2021, the subject experienced tingling in hands. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced increased fatigue. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) normal (units unspecified), and electrocardiogram (NR: not provided) normal (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, tingling in hands, increased fatigue, and dry mouth. This report was non-serious.
61 2021-04-20 hot flush Headache started 4/11/2021 approx 10:30 - ice packs to top of head, over eyes and back of neck, ende... Read more
Headache started 4/11/2021 approx 10:30 - ice packs to top of head, over eyes and back of neck, ended 4/11/2021 approx 1600; Nausea started 4/11/2021 approx 10:30 ended 4/11/2021 1600; Malaise started 4/11/2021 approx 10:30 ended 4/11/2021 ended 1600 sips of water throughout day and nibbled on saltines; photosensitivity (lights brighter than usual) started 4/11/2021 approx 10:30 ending 4/11/2021 1630; Bilateral eye pain started 4/11/2021 10:30 ending 4/11/2021 16:30 pain scale 7 (0 no pain, 10 extreme pain); Hot flashes started 4/11/2021 0800 ending 4/20/2021 0800
61 2021-04-20 pain in extremity, tremor HEADACHE; TIRED; RINGING IN EARS; SHAKING IN ARM; PAIN IN BOTH LEGS; This spontaneous report receive... Read more
HEADACHE; TIRED; RINGING IN EARS; SHAKING IN ARM; PAIN IN BOTH LEGS; This spontaneous report received from a consumer concerned a 61 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced ringing in ears. On 08-APR-2021, the subject experienced shaking in arm. On 08-APR-2021, the subject experienced pain in both legs. On 08-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in ears, headache, shaking in arm, and tired, and the outcome of pain in both legs was not reported. This report was non-serious.
61 2021-04-20 pain in extremity No immediate side effects except for a slightly sore arm. Extreme fatigue began 4 days from date of... Read more
No immediate side effects except for a slightly sore arm. Extreme fatigue began 4 days from date of injection and lasted to day 16. Dizziness and nausea began about 10 days from date of injection but were intermittent. Nausea and dizziness finally resolved around day 16. No lasting side effects to-date.
61 2021-04-22 pain in extremity, burning sensation Patient discribed mild headache immediately after. Patient experienced sore arm for about 10 days. P... Read more
Patient discribed mild headache immediately after. Patient experienced sore arm for about 10 days. Patient started experiencing pain all over a week after the injection. she describes it as a burning sensation though her nervous system and joint pain. Patient also experienced a brain fog a week after her injection. She states that she has trouble putting her thoughts to words. She still feel this reactions on your 17th day.
61 2021-04-22 tingling, numbness Fingers on left hand began tingling around 30 minutes or so after shot. While riding home in the ca... Read more
Fingers on left hand began tingling around 30 minutes or so after shot. While riding home in the car, both the numbness, heaviness feeling in my arm and the tingling worsened. Then a strong sensation went up the left side of my neck and into the left side of my face where my face started tingling. That was so powerful and unexpected it caused me to gasp and grab the side of my neck. My husband turned the car around and we returned to the hospital where they took the information and had me sit for a while checking back a few times. My arm, fingers, neck and face continued to feel numb and heavy with my face and fingers tingling. After no improvement and some escalation as it ebbed and flowed, I had an April 12 appointment with Dr at Medical Center. Some blood work was done afterwards. A PT appt. is set for April 29th. It has been more than two weeks now and unfortunately, the numbness, heaviness and tingling continue.
61 2021-04-22 sensory loss INTENSE HEADACHES; CLICKING IN THE LEFT EAR; PRETTY STRONG SENSATION; NO SENSATION IN BIG TOE AND TO... Read more
INTENSE HEADACHES; CLICKING IN THE LEFT EAR; PRETTY STRONG SENSATION; NO SENSATION IN BIG TOE AND TOE NEXT TO IT; COULD HARDLY SLEEP; COULD HARDLY SEE; COULD HARDLY HEAR (INAUDIBLE); CHILLS; FEVER; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included viral meningitis, nausea, and headache, and concurrent conditions included clotting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for clotting. On 2021, the subject experienced clicking in the left ear. On 2021, the subject experienced pretty strong sensation. On 2021, the subject experienced no sensation in big toe and toe next to it. On 2021, the subject experienced could hardly sleep. On 2021, the subject experienced could hardly see. On 2021, the subject experienced could hardly hear (inaudible). On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced extreme fatigue. Treatment medications included: paracetamol. On MAR-2021, the subject experienced intense headaches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the clicking in the left ear, pretty strong sensation, chills, intense headaches, extreme fatigue, no sensation in big toe and toe next to it, fever, could hardly sleep, could hardly see and could hardly hear (inaudible) was not reported. This report was non-serious.
61 2021-04-23 weakness, pain in extremity LOSS OF APETITE; TINNITUS RINGING IN EARS; HEADACHE; LEG PAIN; HEAVINESS; LOSS OF ENERGY; CHILLS; FE... Read more
LOSS OF APETITE; TINNITUS RINGING IN EARS; HEADACHE; LEG PAIN; HEAVINESS; LOSS OF ENERGY; CHILLS; FEVER; TIRED; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced leg pain. On 06-MAR-2021, the subject experienced heaviness. On 06-MAR-2021, the subject experienced loss of energy. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced tired. On 07-MAR-2021, the subject experienced tinnitus ringing in ears. On 07-MAR-2021, the subject experienced loss of apetite. On 07-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain, heaviness, and chills on 07-MAR-2021, and fever, and headache on 09-MAR-2021, was recovering from tinnitus ringing in ears, and had not recovered from tired, loss of apetite, and loss of energy. This report was non-serious.
61 2021-04-23 pain in extremity CHILLS; PAIN IN HANDS; HEADACHE; VERY TIRED; MUSCLE ACHES; PAIN IN ELBOW; This spontaneous report re... Read more
CHILLS; PAIN IN HANDS; HEADACHE; VERY TIRED; MUSCLE ACHES; PAIN IN ELBOW; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not have known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced pain in hands. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced very tired. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021, the subject experienced pain in elbow. Treatment medications included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-MAR-2021, was recovering from pain in hands, and pain in elbow, and had not recovered from very tired, muscle aches, and chills. This report was non-serious.
61 2021-04-23 pain in extremity TINNITUS; INSOMNIA; CHILLS; ACHINESS DOWN LEFT LEG; NAUSEA; HEADACHE; FEVER; This spontaneous report... Read more
TINNITUS; INSOMNIA; CHILLS; ACHINESS DOWN LEFT LEG; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included degenerative disc, and concurrent conditions included osteoarthritis, non alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with ceclor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 19:20 to left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced achiness down left leg. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 12-MAR-2021, the subject experienced tinnitus. On 12-MAR-2021, the subject experienced insomnia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, achiness down left leg, nausea, and fever on 11-MAR-2021, and had not recovered from tinnitus, headache, and insomnia. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
61 2021-04-24 tingling Super Dizzy (2 days), nausea (4 days), tingling throughout body (5 days), fatigue (10 days), Severe ... Read more
Super Dizzy (2 days), nausea (4 days), tingling throughout body (5 days), fatigue (10 days), Severe body aches. Felt like every bone in my body was broken (4 days)
61 2021-04-26 cold sweat, pain in extremity, burning sensation UPPER SPINE WAS VERY TENDER; COLD SWEAT; COULD NOT STAND UP FROM FLOOR; SEVERE DIARRHEA; FELT LIKE S... Read more
UPPER SPINE WAS VERY TENDER; COLD SWEAT; COULD NOT STAND UP FROM FLOOR; SEVERE DIARRHEA; FELT LIKE SOMETHING HAPPENED; ARM PAIN; BURNING HEAT OFF BODY; BRUISING AT UPPER SPINE/YELLOW BRUISING DOWN LOWER LEFT LEG; SEVERE PAIN UP NECK AND DOWN BACK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sensitive to antibiotics, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced bruising at upper spine/yellow bruising down lower left leg. On 04-MAR-2021, the subject experienced severe pain up neck and down back. On 04-MAR-2021 14:00, the subject experienced burning heat off body. On 05-MAR-2021, the subject experienced arm pain. On 07-MAR-2021, the subject experienced cold sweat. On 07-MAR-2021, the subject experienced could not stand up from floor. On 07-MAR-2021, the subject experienced severe diarrhea. On 07-MAR-2021, the subject experienced felt like something happened. On 19-MAR-2021, the subject experienced upper spine was very tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper spine was very tender, bruising at upper spine/yellow bruising down lower left leg, and severe pain up neck and down back on 07-APR-2021, burning heat off body on 04-MAR-2021, and cold sweat, could not stand up from floor, and severe diarrhea on 07-MAR-2021, and the outcome of arm pain and felt like something happened was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
61 2021-04-26 pain in extremity CHEST PAIN; RIGHT ARM PAIN; HEADACHE; This spontaneous report received from a patient concerned a 61... Read more
CHEST PAIN; RIGHT ARM PAIN; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 150 pounds, and height was 59 inches. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the patient experienced chest pain, right arm pain, headache and was hospitalized (date unspecified). She was en route to MRI and had to hang up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain, chest pain, and headache. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210427406-covid-19 vaccine ad26.cov2.s-Chest pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210427406-covid-19 vaccine ad26.cov2.s-Right arm pain, headache. This event(s) is labeled per Agency and is therefore considered potentially related.
61 2021-04-26 tingling Arms feeling tingly and scratchy throat. Paramedics at bedside.
61 2021-04-27 pain in extremity For the past 2 1/2 - 3 weeks I have had a pain in my left leg. Today it was extremely painful so I ... Read more
For the past 2 1/2 - 3 weeks I have had a pain in my left leg. Today it was extremely painful so I went into the dr. office and after an examination and ultra sound it was determined that I have a blood clot.
61 2021-04-27 pain in extremity Pt called the call center. Reporting cold like symptoms"coughing, body aches, chills, both arms hur... Read more
Pt called the call center. Reporting cold like symptoms"coughing, body aches, chills, both arms hurting, fatigue" after J&J covid vaccine 4/9/2021. Pt is taking ginger tea for symptoms but no medication. Pt denies emergency s/sx. Urgent Care appt made but pt no showed on4/21/21. New appt scheduled for 4/23/21. COVID test negative on 4/23/21.
61 2021-04-30 pain in extremity, burning sensation, fibromyalgia FIBROMYALGIA EXACERBATION; SORE GLANDS AT JAW LINE; FEELING LIKE CENTRAL NERVOUS SYSTEM ON FIRE; SPI... Read more
FIBROMYALGIA EXACERBATION; SORE GLANDS AT JAW LINE; FEELING LIKE CENTRAL NERVOUS SYSTEM ON FIRE; SPINAL CORD PAIN; VERTIGO; SORE ARM; NAUSEOUS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, atrial fibrillation, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: (6 or 0)43A(2or Z)(Ior1)A) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fibromyalgia exacerbation. On APR-2021, the subject experienced sore glands at jaw line. On APR-2021, the subject experienced feeling like central nervous system on fire. On APR-2021, the subject experienced spinal cord pain. On APR-2021, the subject experienced vertigo. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced nauseous. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vertigo, sore arm, sore glands at jaw line, feeling like central nervous system on fire, spinal cord pain, fibromyalgia exacerbation and nauseous was not reported. This report was non-serious. The Product Complaint Number was 90000177550 The suspected product quality complaint has been confirmed to be confirmed no PQC was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.
61 2021-05-05 weakness About 10 hours after receiving the vaccine I became nauseous and weak. I sat down on a kitchen chai... Read more
About 10 hours after receiving the vaccine I became nauseous and weak. I sat down on a kitchen chair and then passed out, falling to my right onto the floor.
61 2021-05-05 numbness, speech disorder, inability to speak 3/18/21, Day after Vaccine, drowzy in the morning, around 12:00 p.m. I had a brief period of incohe... Read more
3/18/21, Day after Vaccine, drowzy in the morning, around 12:00 p.m. I had a brief period of incoherent speach and a few moments of having trouble putting sentences together. Around 2:00 a moment of temporary blindness in my left eye. 03/19/21 -03/20/21, extreme fatigue, stayed in bed. 03/21/21, fatigue, light-headed, slightly dizzy 03/22/21, right side leg and arm became numb as if asleep. Went to Hospital Emergency. I had a stroke, had a Carotid Endarterectomy at medical center, was in the Hospital for 5 days, two weeks after surgery became seriously enemic and d_Dimers are still elevated THE CONTINUATION PAGE IS INOPT. AND WOULD HAVE LIKED TO EXPLAIN IN FURTHER DETAIL.
61 2021-05-06 numbness My left foot felt very heavy then my left lower leg started to get numb. We all 911 by the time th... Read more
My left foot felt very heavy then my left lower leg started to get numb. We all 911 by the time the ambulance came my left arm was getting numb. I was transported in helicopter to regional Hospital I was having a stroke
61 2021-05-06 tremor, burning sensation That night, no chills or fever but uncontrollable shaking - 10 pm - 4 am in morning. Starting at 10,... Read more
That night, no chills or fever but uncontrollable shaking - 10 pm - 4 am in morning. Starting at 10, as well, body aches - run over by a truck type. My chest was burning like it was on fire - lungs felt like they were on fire. I woke up the next morning, with a little bit of body aches - I slept the entire next day pretty much (the 7th). On the 7th, I noticed that my heart was beating - fluttering- skipping- beating. My left left also swelled up and was red. I had PVCs with pulmonary embolism on that left leg in1996 - when I was doing the chemo. My left leg ached, burned and got red on the 7th. I was going to see the PCP the following week and I was still having issues with the heart but the leg was getting better. It can still swell, burn and get red quite a bit of night because I stand on my legs all day - but the amount of pain and swelling did go down over that week while I was waiting to see the doctor. I had an ultrasound on my leg. And a heart halter to monitor my heart for 24 hours. I do have PVCs. Stress from vaccine caused Herpes Outbreak - that was on the left inner thigh right next to genitals - bumps within four days of vaccine. Created more pain. Took Benadryl for pain - helps with the nerve pain - two days with. I took 3000 mg a day of Tylenol for three days after the vaccine. Have not recovered from the calf and heart symptoms.
61 2021-05-07 pain in extremity Immediately after my J&J vaccine, I experienced soreness to my left arm, fatigue , dizziness and a b... Read more
Immediately after my J&J vaccine, I experienced soreness to my left arm, fatigue , dizziness and a bad headache. In the middle of the night my headache kept getting worse, my eyes started to hurt really bad and I also broke out in hives. About 6 hours later my headache felt like it wanted to explode. I saw a doctor through Tele-health by who prescribed a 6pk of steroids. Then on Day 6, my headaches came back along with the hives and I felt really tired and the hives broke out all over my body including my crotch and ear canal. He prescribed a 6pk of steroids and I started to feel and get better. On Day9, all of my symptoms were resolved except for the fatigue. To this day I still continue to have fatigue.
61 2021-05-08 pain in extremity Pain in right leg in knee area beginning on 4/6/2021. Pain worsened over the weekend. Went to the ... Read more
Pain in right leg in knee area beginning on 4/6/2021. Pain worsened over the weekend. Went to the doctor on 4/14/2021. She sent me for a doppler on my legs where a blood clot was found behind my right knee. I started taking Xarelto that night - 15mg twice daily for 21 days. The pain increased considerable and by 4/20/2021 I could hardly walk. I went back to the doctor that day and she ordered a second doppler study. The blood clot was stable but there was no change. Continued on the Xarelto. Third visit to the doctor on 5/5/2021. Some lessening of the pain by then. Doctor changed the Xarelto dosage to 20 mg. one a day for the next two months. Then we'll schedule another doctor visit and probably another Doppler Study.
61 2021-05-10 pain in extremity right leg pain started 5 days after vaccination. Went to the ER on 5-1-2021 x-rays, ultrasound and b... Read more
right leg pain started 5 days after vaccination. Went to the ER on 5-1-2021 x-rays, ultrasound and blood work done. Diagnosed with a deep vein thrombosis blood clot in the right leg. given Eliquis starter pack 2 tabs 10 mg each twice a day for 7 days, 1 5mg each tabs twice a day, ongoing Tramadol 50mg 1 every 6 hours for severe pain Acetaminophen 500mg 1 every 4 hours for pain Ondansetron 4mg as needed for nausea/vomiting
61 2021-05-11 weakness Was fine after receiving the shot at 11 AM . Then at about 8 o?clock at night I had violently severe... Read more
Was fine after receiving the shot at 11 AM . Then at about 8 o?clock at night I had violently severe chills fever nausea weakness and tiredness. Was unable to perform daily to asks the whole next day.
61 2021-05-11 pain in extremity I have daily headaches since 04/12/2021. Wednesday evening 04/12 I was working and felt a vice like ... Read more
I have daily headaches since 04/12/2021. Wednesday evening 04/12 I was working and felt a vice like grip on my head. I had acute leg pains in my sleep that evening but not since then. Every day since then I have a headache. It feels like swelling in my brain (and heat) and I'm very upset and unhappy about it. I am a very healthy with no health problems. I don't go to doctor or even have a doctor (except a gyn). The headaches have not subsided and are causing me quite a bit of stress.
61 2021-05-13 flushing first day joint stiffnes. On second day until today I have had hives and flushness to the face.
61 2021-05-17 feeling hot, facial paralysis, flushing, speech disorder 3/20/2021 @ 1:00 vaccination I sat in a chair for 5 minutes. After, I felt warm, I was flushed. Fif... Read more
3/20/2021 @ 1:00 vaccination I sat in a chair for 5 minutes. After, I felt warm, I was flushed. Fifteen minutes later I walked out, driving down road with friend and I said 'something is wrong'; really bad 'metal taste' in mouth, blurred vision, grabbed her arm and said I am going to throw up, I was so dizzy and I said I can't think. My face was drooping, I couldn't say my A,B,C's, and by the time I got to the ER they got me on an IV. I couldn't talk, think, and had the metal taste for a few hours. The dr. said we are going to give you fluids, my BP was elevated for 6 hours 198/130, no clots. BP went down to 178/98, taste started to go down, I was drinking fluids, I was able to talk a little bit. I felt like in a 'bubble', I couldn't think. When I was discharged I had no temp, my BP was normal. *my body reacted to the vaccination. *6 hours my body reacted *body had felt like I was recovering from the flu for 2 weeks *Never ran a temperature
61 2021-05-18 pain in extremity About 5 pm on 4/13 my right upper calf started having a pain. Its still hurting today. sent me for... Read more
About 5 pm on 4/13 my right upper calf started having a pain. Its still hurting today. sent me for imaging.
61 2021-05-19 pain in extremity I arrived home and my arm was throbbing really bad and broke out all over with hives (looks like mea... Read more
I arrived home and my arm was throbbing really bad and broke out all over with hives (looks like measles).
61 2021-05-23 pain in extremity Developed a DVT in left calf on 5/10/21. Suffered a fractured metatarsal bone in left foot on 4/13/... Read more
Developed a DVT in left calf on 5/10/21. Suffered a fractured metatarsal bone in left foot on 4/13/21 and a walking boot was prescribed. Foot healed excellently but developed a DVT .
61 2021-05-23 pain in extremity I had pain in my arm.
61 2021-05-24 pain in extremity, muscle spasms pt says she started having constant pain from her left leg from the knee to her hip along with muscl... Read more
pt says she started having constant pain from her left leg from the knee to her hip along with muscle spasms that she has had for the past 3 days. She is taking ibuprofen and muscle rub. Pt will contact a doctor if her symptoms get worse.
61 2021-05-25 weakness Insomnia, muscle aches and weakness. Back pain, severe headaches, fatigue. Abnormal D-Dimer levels. ... Read more
Insomnia, muscle aches and weakness. Back pain, severe headaches, fatigue. Abnormal D-Dimer levels. Shortness of breathe and chest pain.
61 2021-05-25 weakness Insomnia, muscle aches and weakness. back pain, severe headaches, fatigue. Abnormal D-Dimer levels. ... Read more
Insomnia, muscle aches and weakness. back pain, severe headaches, fatigue. Abnormal D-Dimer levels. Shortness of breath and chest pain.
61 2021-05-31 pain in extremity Sore arm immediately. Headache, body aches and chills started within 3 hours. This lasted for 2 da... Read more
Sore arm immediately. Headache, body aches and chills started within 3 hours. This lasted for 2 days. I had an off and on headache for a couple more days.
61 2021-06-03 pain in extremity PAIN IN ELBOW LOWER ARM AND HAND
61 2021-06-06 seizure, weakness, tremor Patient presented to PCP on 05/18/2021 office from group home with C/O cough, runny nose, lethargic... Read more
Patient presented to PCP on 05/18/2021 office from group home with C/O cough, runny nose, lethargic, fever, lungs rattling, uncontrollable shaking. Patient had a seizure the night before and had been having weak spells and coughing and fever since that time. Patient admitted to hospital on 05/18/2021 and chest Xray showed pneumonia. Patient tested for COVID-19 on 05/21/2021 after learning of potential exposure at group home and result was positive.
61 2021-06-08 weakness I start of feeling sick in the stomach, headache, muscle aches, feverish. By that night I had chills... Read more
I start of feeling sick in the stomach, headache, muscle aches, feverish. By that night I had chills and the really bad nausea, that I had to sleep on the bathroom. The next day, I barely made it to the bed. I am very weak, still having a headache, body aches and feeling fatigue. The ringing in my ear has gotten worst than it was before.
61 2021-06-08 pain in extremity 5/07/2021 I had the shot and immediately I got dizzy when I stood up. That night I encountered fatig... Read more
5/07/2021 I had the shot and immediately I got dizzy when I stood up. That night I encountered fatigue, fever, muscle ache and sore throat. Fever lasted 2 days and fever lasted for 5 days. 5/10 the arm was sore and there was a 6x6? huge rash. 5/24- 5/26 I had a rash that I kept under control with Benadryl. 5/29 my saliva glands began to swell and that?s why I went to the Doctor. The Dr sent me to an ENT and Rheumatologist.
61 2021-06-13 facial pain, numbness Janssen COVID-19 Vaccine 13 days after receiving her Covid vaccine, the patient stated ?I have been... Read more
Janssen COVID-19 Vaccine 13 days after receiving her Covid vaccine, the patient stated ?I have been experiencing bad headaches that makes the right side of my face numb and/or painful to the touch. Although I have had headaches in the past, these feel different.? Patient stated that she started noticing these headaches late in the week that followed that administration of the vaccine (beginning on or around 6/4/21) Patient also stated that she began developing stomach aches approximately one week following the vaccine administration (beginning on or around 6/6/21)
61 2021-06-14 pain in extremity Whole left side pain from head to calf. Temp at 104 for 16hrs. Headache, ears ringing, stomach pain,... Read more
Whole left side pain from head to calf. Temp at 104 for 16hrs. Headache, ears ringing, stomach pain, strong pain left leg left side of thigh. Felt like a bus hit my left side. Severe fatigue. Congestion.
61 2021-06-15 tingling Sore throat, tingling on left top of scalp (usual site). Presented as another flare-up of Shingles,... Read more
Sore throat, tingling on left top of scalp (usual site). Presented as another flare-up of Shingles, but Zoster sine herpete (ZSH). Two days later, I visited my PA, and she immediately started me on Valtrex (1g/3x daily) and gabapentin.
61 2021-06-17 numbness, tingling BONES HURTING SEVERELY ALL OVER THE HIPS KNEES ANKLES RIBS ARMS AND BACK; TINGLING IN RIGHT ARM; NUM... Read more
BONES HURTING SEVERELY ALL OVER THE HIPS KNEES ANKLES RIBS ARMS AND BACK; TINGLING IN RIGHT ARM; NUMBNESS IN RIGHT ARM; BODY ACHES LIKE THE FLU; LIPS TINGLING BUT NOT SWOLLEN HAPPENED ONLY ONCE FOR HALF HOUR; SQUEEZING LIKE PRESSURE ON RIGHT ARM FELT LIKE RUBBER AROUND BANDS ARMS AND BLOCKING CIRCULATION; JOINT PAIN; HEADACHE ON RIGHT TOP SIDE OF HEAD; FEVER TEMP HIGHEST 104.1F TO RANGE OF 102F; MUSCLE PAIN; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient not tested positive for covid, not aware that has had covid before, ended up in emergency room last fall due to non covid virus. The patient experienced got sick like in vomiting when treated with hydromorphone hydrochloride, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced bones hurting severely all over the hips knees ankles ribs arms and back. On 15-JUN-2021, the subject experienced tingling in right arm. On 15-JUN-2021, the subject experienced numbness in right arm. On 15-JUN-2021, the subject experienced body aches like the flu. On 15-JUN-2021, the subject experienced lips tingling but not swollen happened only once for half hour. On 15-JUN-2021, the subject experienced squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation. On 15-JUN-2021, the subject experienced joint pain. On 15-JUN-2021, the subject experienced headache on right top side of head. On 15-JUN-2021, the subject experienced fever temp highest 104.1f to range of 102f. On 15-JUN-2021, the subject experienced muscle pain. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lips tingling but not swollen happened only once for half hour on 15-JUN-2021, and was recovering from tingling in right arm, squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation, numbness in right arm, fever temp highest 104.1f to range of 102f, body aches like the flu, headache on right top side of head, muscle pain, joint pain, and bones hurting severely all over the hips knees ankles ribs arms and back. This report was non-serious.
61 2021-06-20 seizure Severe drop in blood presure leading to waterfall stroke and seizure. According to neurologist brai... Read more
Severe drop in blood presure leading to waterfall stroke and seizure. According to neurologist brain damage is permanent and non reversible.
61 2021-06-21 pain in extremity SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; SORE ARM; This spontaneous report received from a patient c... Read more
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; SORE ARM; This spontaneous report received from a patient concerned a 61 year old female of an unspecified race and ethnicity. The patient's weight was 265 pounds, and height was 69 inches. The patient's concurrent conditions included seasonal allergies, non-smoker, and non-alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient was not pregnant at time of report. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, 1 total administered on 06-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced sore arm. On an unspecified date patient underwent through laboratory test included: Antibody test revealed negative (suspected immunological vaccine failure) was reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 08-MAR-2021, and the outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210637750. This report was associated with product quality complaint: 90000183360.; Sender's Comments: V0 ; 20210637986- COVID-19 VACCINE AD26.COV2.S-SUSPECTED IMMUNOLOGICAL VACCINE FAILURE . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
61 2021-06-23 tremor the patient came back med opts 1 shaky, warm, and slightly sweaty. she said her tongue was itchy and... Read more
the patient came back med opts 1 shaky, warm, and slightly sweaty. she said her tongue was itchy and had slightly labored breathing. Patient also said she was diabetic and was given apple juice. Vitals- TIME: 4:37 HR: 116 RESP: 14 BP:168/100 SP02: 94%
61 2021-06-24 muscle spasms, tremor Severe Chills and shaking repeated nightly for 5 nights Body aches, vertigo, nausea, headache , musc... Read more
Severe Chills and shaking repeated nightly for 5 nights Body aches, vertigo, nausea, headache , muscle cramp at injection site resolved slowly over 3 weeks
61 2021-06-26 breast pain 04-23-21 - Woke up super dizzy & was unable to get out of bed for about 30 mins after that I had to ... Read more
04-23-21 - Woke up super dizzy & was unable to get out of bed for about 30 mins after that I had to VERY carefully move around slowly for weeks after that (until mid June) I also had ringing in my ears for most of that time pretty severe at first & still present but better that when I was dizzy. I had not had this before & it is quite unnerving. I have been doing PT for the dizziness & it has pretty much subsided. I have also had pain (no rash or lymph discomfort or swelling) just muscular pain in my upper right arm. This started about a month after the vaccination. It is in the arm muscle NOT the bursa. It happens when I have not moved the arm for awhile & I reach for something, etc.. the pain is not severe but obvious (0 to 10 it is about a 4) & goes down to about a 1 after I move the arm around for 30 seconds or so. I have also had pain & a bit of weakness in my legs & a sharp pain in my left beast (not my chest - the upper left quadrant about 1" below my armpit & 3 inches in the breast tissue. It is a single sharp pain (0 to 10 = 7) and only stays for a few minutes.
61 2021-06-26 migraine 25 June 11 pm: Entire body aching -- Up multiple times during the night, general muscle aching and ... Read more
25 June 11 pm: Entire body aching -- Up multiple times during the night, general muscle aching and fatigue, some confusion; migraine developed overnight. 26 June, 7 am: Out of bed, short walk, general myalgia, fatigue, migraine, had to lie down. 8:30 am: Slightly longer walk, felt slightly better, able to eat small amount after this. 9:30: Felt nauseated, migraine, fatigue, and myalgia worse. Noon: Brief walk outside, lay back down due to nausea, fatigue, myalgia. 2:30 pm: Nausea a bit better, ate apple, lay back down due to symptoms above. 5 pm: Migraine and nausea slightly better, fatigue and myalgia persist. 6:30 pm: Ate plain lettuce, extreme nausea, and tinnitus; vomited entire quantity; nausea improved. Remained prone rest of evening. 7:30 pm: Mild nausea persists, migraine improving, may be slight decrease in myalgia. 9 pm: To bed, slept well, definite improvement through night, some myalgia persists and occasional tinnitus. Able to drink water throughout.
61 2021-06-30 pain in extremity Day 1: Shot Friday about 530 PM. Waited 30 minutes+. VERY ITCHY skin within minute or more of inject... Read more
Day 1: Shot Friday about 530 PM. Waited 30 minutes+. VERY ITCHY skin within minute or more of injection. Skin itched all over, but no rash, no other symptoms. Took usual aspirin & Tylenol before bed. Also began probiotics and elderberry/zinc/C supplements recommended in Covid handout. That night: Slept on other arm, when rolled over in early AM, hurt to press on shot arm. Day 2: Woke up hay feverish - sinuses completely blocked but could breathe through mouth, so airway OK. Moderate headache, all over muscle aches. Took usual aspirin & Tylenol. Skin still itches all over. Took a Zyrtec. Sinuses cleared, muscles and head aches went from moderate to mild, skin itch also from moderate to mild. Took usual aspirin & Tylenol before bed. Day 3: Woke up with sinuses partially blocked and sneezing. Mild headache and muscle aches. Took usual aspirin & Tylenol, and when sinuses wouldn't clear on sitting up and blowing and kept sneezing, took another Zyrtec. Day 4: Sinuses draining so I'm going to try to do without Zyrtec. Body still very achy so taking usual aspirin & Tylenol. Day 5 and beyond: Symptoms gradually subsided without further Zyrtec. Higher than normal tiredness persisted longer than aches and hay fever symptoms. Overall, much milder reaction than I had to a flu vaccine many years earlier, so I'm pleased, but felt VAERS should have complete information.
61 2021-07-01 feeling hot ENTIRE BODY FEELING HOT AND FELT LIKE ON FIRE; This spontaneous report received from a patient conce... Read more
ENTIRE BODY FEELING HOT AND FELT LIKE ON FIRE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was not reported and height was 64 centimeters. The patient's past medical history included difficulty breathing, and hurting around heart, and concurrent conditions included alcoholic (40s per day beer), and smoker, and other pre-existing medical conditions included the patient did not have any known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced entire body feeling hot and felt like on fire. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of entire body feeling hot and felt like on fire was not reported. This report was non-serious.
61 2021-07-04 pain in extremity Extremely painful when vaccine was injected into my arm! The pain radiated up and into my left jaw. ... Read more
Extremely painful when vaccine was injected into my arm! The pain radiated up and into my left jaw. I could taste the vaccine. Before the injection I discussed the fact that I have many allergies and my concern that the form didn?t ask which vaccines I had had anaphlaxic reactions to. My tongue immediately became slightly swollen. By the time I arrived home an hour later, I could barely left my left arm, I was sick to my stomach and almost started to dry heave; it passed in about 10 minutes. My tongue remained swollen until 7:00 pm 6/30/2021. My arm remained extremely sore until 7/01/2021; the injection site still hurts a little as of 07/05/2021.. on 07/02/2021 I had chills until approximately 5:30 pm. I carry Epi-pens should I need to self administer.
61 2021-07-08 muscle spasms, pain in extremity So on Friday at 10:30PM On the Friday 25th of June, I had GI issues and a lot of stomach pain. I als... Read more
So on Friday at 10:30PM On the Friday 25th of June, I had GI issues and a lot of stomach pain. I also had cramping and pain in the back of my legs as well. I went to the DR and she put me on antibiotics, Cipro and something else I cannot remember. I went to the DR on Wednesday the 30th of June. The GI problems have been happening for about 2 weeks. I also saw my cardiologist on 4/8/2021 and he saw I was ok, the pulmonary DR also said my lungs looked fine on 4/26/2021.
61 2021-07-11 weakness My stomach pain started a couple weeks after the vaccine. On May 8, I went to the ER because I had l... Read more
My stomach pain started a couple weeks after the vaccine. On May 8, I went to the ER because I had left side abdominal pain. I was prescribe antibiotics and given an IV of antibiotics. On the 12th, I called my doctor again and I was admitted me to the hospital. I still feel weak and have abdominal pain on and off. I am scheduled for a colonoscopy on July 23, 2021.
61 2021-07-11 facial pain, nerve pain My gums were inflamed they felt like they were pulling away from my teeth. My gums were discolored. ... Read more
My gums were inflamed they felt like they were pulling away from my teeth. My gums were discolored. I had cavities and it made the pain unbearable. All my teeth felt loose like they were going to fall out. I went to a dentist but no dentist could prescribe me any medication. It hurt from my ear all the way to center of the jaw. I got some antibiotics from my doctor but soon as I finished the pain would come right back. I did three rounds of antibiotics back-to-back. I went to an oral surgeon and he said the antibiotics were not working and he had to pull two of my teeth. The pain was has been unbearable, it feels like nerve pain. I did have some bloodwork sometime during this but I don't remember when.
61 2021-07-11 pain in extremity, burning sensation, nerve injury Lower leg down to foot had a burning, severe pain. Healthcare professional diagnosed with nerve dama... Read more
Lower leg down to foot had a burning, severe pain. Healthcare professional diagnosed with nerve damage. Currently seeing a Neurosurgeon. Dr.
61 2021-07-12 weakness Weakness, blurry vision, achy bones, tiredness, hard to breathe, weakness in muscles, brain fog,
61 2021-07-12 tingling On 15th of June I began throwing up, couldn't keep food down, major cramping in my stomach, wouldn't... Read more
On 15th of June I began throwing up, couldn't keep food down, major cramping in my stomach, wouldn't go away, chills that lasted until 6/24, I took peptol bispol, tums, ginger, but still cramped and threw up, couldn't eat, slept a lot because of pain. I did stop taking the metrondasel antibotic given for my swallon jawl, kept taking Pennicillin because I'm not allergic. I was very weak, on vacation when this started, couldn't be out in the side much at all, felt like I was going to pass out. Later in week begin having tingling in my feet like they were going to sleep and in my upper legs/hips. I do have stents in my legs that are doing well, so it kind of worried me that they were tingling. On 24th of June, went to my doctor, she gave me Hyoscyamine for pain/discomfort in my stomach and back, also PureGG 25B for probiotic. It's been working ok, but still having stomach episodes of pain and goes to my back like sharp object. Also I've never had heartburn until this sickness, have to have tums and something for pain every once in a while, should've been over all of this by now, but have called the new doctor because I'm not sure what's going on. I'm not a sickly person.
61 2021-07-12 speech disorder, tremor SYNCOPE/COLLAPSED; FELL DOWN; TREMBLING; HYPERVENTILATED; BLOOD PRESSURE WAS VERY DOWN; COULD NOT TA... Read more
SYNCOPE/COLLAPSED; FELL DOWN; TREMBLING; HYPERVENTILATED; BLOOD PRESSURE WAS VERY DOWN; COULD NOT TALK; HIT HEAD; HIT HAND; HIT ELBOW; BUMP ON HEAD, ELBOW, AND HAND; HEADACHE; This spontaneous report received from a patient concerned a 61 year old Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2076A21A, and expiry: unknown) dose was not reported, frequency 1 total, administered on 07-JUL-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 07-JUL-2021, after receiving vaccine, the patient felt dizzy and could not talk. The patient fell down and hit her head, hand, and elbow. Paramedics were called to help the patient and she was taken to emergency room (ER). The patient was informed that her blood pressure was very down, she was hyperventilated and was trembling. On the same day, the patient felt fine and experienced headache after going home and noted bump on her head, hand, and elbow because of the fall. The patient was diagnosed with syncope/collapsed. Laboratory data included: Blood pressure (NR: not provided) Decreased, and Laboratory test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from syncope/collapsed, trembling, hyperventilated, blood pressure was very down, and could not talk, and the outcome of fell down, hit head, hit hand, hit elbow, headache and bump on head, elbow, and hand was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:- 20210718537- covid-19 vaccine ad26.cov2.s-syncope/collapsed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
61 2021-07-14 numbness, feeling hot See other question -- described there
61 2021-07-19 tingling, numbness Numbness in fingers and toes - tingling sensation - wrist - hand- finger- feet & toes. Weird headach... Read more
Numbness in fingers and toes - tingling sensation - wrist - hand- finger- feet & toes. Weird headache especially when I sleep.
61 2021-07-26 slurring on April 11, 2021 I experienced confusion and unable to read or say a few words correctly. I ended u... Read more
on April 11, 2021 I experienced confusion and unable to read or say a few words correctly. I ended up calling my Dr who insisted I go to the ER. I was admitted to the hospital and after 2 days and many tests it was determined I had a small stroke.
62 2021-03-04 feeling cold, tremor 8 hours after getting the vaccine I started feeling very cold. It came on me all of a sudden. Shaki... Read more
8 hours after getting the vaccine I started feeling very cold. It came on me all of a sudden. Shaking, shivering, teeth chattering ensued along with generally feeling very unwell. (Similar to how I felt years ago after having surgery) This progressed during the night to fever, chills, extreme body aches, stabbing pains in the head, heart racing, dizziness and nausea. After 12 hours I started to feeling improvement. At the 16 hour mark I am really tired and nauseous but feel like I'm coming back. Probably the worst I've ever felt. We considered going to the ER in the night.
62 2021-03-06 tremor Janssen COVID-19 Vaccine EUA. Gradual headache late afternoon, followed by neck ache, then muscle a... Read more
Janssen COVID-19 Vaccine EUA. Gradual headache late afternoon, followed by neck ache, then muscle aches, Horrible chills and shakes, nausea and throwing up. Muscle aches continued throughout the night and into the morning. Left with some muscle aches, stuffy head today. Tylenol did not help in the evening, so switched to Advil at midnight and that started to help.
62 2021-03-07 weakness Heart rate over 100 bpm for 24 hours, dizziness, weakness
62 2021-03-07 pain in extremity, muscle spasms, weakness While waiting the 15 required minutes after the shot was administered..I experianced a headache and ... Read more
While waiting the 15 required minutes after the shot was administered..I experianced a headache and left jaw discomfort. Minor arm pain the first day, I expected that. Did my regular errands and was fine, a little tired. The next day, (Sunday)...I went to church, had a headache, arms aching like mad, arthritic symptoms , legs cramping, joint pain in elbows especially, were off the chain! I returned home and took immediately to the couch, where I had a low grade fever and stayed all day. I had no appetite, no energy to get up except to go to the bathroom.
62 2021-03-08 numbness, tingling Patient stated after about 15 minutes after receiving vaccine that her face felt numb, she said it f... Read more
Patient stated after about 15 minutes after receiving vaccine that her face felt numb, she said it feels like it spread from her arm where the shot was given up into her neck and into her face which was numb and tingly
62 2021-03-08 tremor Shakes & Chills,Muscle Aches in legs, 101 Fever Fatigue
62 2021-03-10 numbness, pain in extremity started vomiting at 1:30 and I felt really dizzy and confused. My roommate found me on the floor pas... Read more
started vomiting at 1:30 and I felt really dizzy and confused. My roommate found me on the floor passed out. I am not sure how long I was passed out. I woke up and I was talking gibberish. I was aware that nothing I said was making sense. I went to bed and slept almost 24 hours. I woke up feeling wiped out but I wasn't confused and I was talking normal again. Right arm hurt and is numb. ( right side of my body typically is kind of numb but the right arm seemed more so numb after the vaccine)
62 2021-03-14 weakness fever, chills, body aches, very weak. Lasted for 3 days. Just starting to feel better now.
62 2021-03-14 burning sensation Intense intermittent itching and redness, mainly on tops of feet and occasionally on wrists and arms... Read more
Intense intermittent itching and redness, mainly on tops of feet and occasionally on wrists and arms. On 7th day, hives with raised red bumps and welts and intense burning itch appeared on lower legs. These gradually spread to upper legs and abdomen over several hours. After taking OTC antihistamine, itching subsided. Rash was gone the following day.
62 2021-03-14 pain in extremity Upper body achy ness & headache. Symptoms started around 5:00 PM & subsided overnight & by following... Read more
Upper body achy ness & headache. Symptoms started around 5:00 PM & subsided overnight & by following morning headache diminished. Sore upper arm the following Thursday evening,
62 2021-03-16 muscle spasms, pain in extremity, migraine Patient went to the ER the morning after receiving the vaccine because she reports she was experienc... Read more
Patient went to the ER the morning after receiving the vaccine because she reports she was experiencing a severe migraine with ear and eye pain, nausea, vomiting, diarrhea, pain in hands and feet, and muscle spasms that last for 4 days.
62 2021-03-17 flushing A few minutes after the vaccine my heart began palpatating and I began sweating profusely. My vital... Read more
A few minutes after the vaccine my heart began palpatating and I began sweating profusely. My vitals were checked, I was given water and moved to a cooler area of the facility. HR was still elevated but I wasnt feeling as flushed. By 4pm that evening I began having having chills and a fever of 100-100.4 which lasted about 4hrs. Later that evening my HR elevated to 125 with the feeling of feeling I was having a heart attack. By that Wed. my HR was still at 125 in motion and about 75 still so I went to visit my PCP on Thurs and when I arrived the HR was 77 but during the visit it elevated to 125 and blood work was done resulting in my tyroid level elevated and since getting the vaccine my HR had been up and down. When in motion its elevated and when sitting its around 75.
62 2021-03-17 pain in extremity My wife got the J&J shot last Wednesday and had the typical sore arm and a little fatigue. On the fo... Read more
My wife got the J&J shot last Wednesday and had the typical sore arm and a little fatigue. On the following Saturday she had a very severe episode of anger at the members of our household and wanted to leave our marriage, sell the house, and said she could not live like this anymore. She slammed doors, yelled and screamed, insulted everyone around her, and would not listen to reason. 3 days later she is calming down somewhat but still has a lot of anger. I have lived with the woman for over 30 years and have never seen anything like this before. She does have her moments and has had mood swings in the past but this episode was exceptional. I think she will be OK in a few more days but I wanted to report this to possibly prevent something similar from happening to others. It is possible this episode was unrelated to the vaccine. It is also possible this is related to her heavy use of Neurontin with Prozac. Let me know if you have questions.
62 2021-03-20 weakness Janssen COVID-19 Vaccine EUA I received the single dose at 10:40. In approximately 11 minutes I sta... Read more
Janssen COVID-19 Vaccine EUA I received the single dose at 10:40. In approximately 11 minutes I started to experience shortness of breath. I thought it was my N95 mask so decided to head to the car after my 15 minute wait period was completed. After sitting down in the car I started the following symptoms: shortness of breath, rapid heart rate, swelling of face, dizziness, weakness. I sit in the car for approximately 15 minutes then headed home. I had a driver (thank goodness). I continued to have symptoms and what felt like elevated blood pressure (I did not have access to a pressure cuff). After resting at my driver's house for about 5 hours I felt better and headed home. The next morning the symptoms were less but still present. In addition I had a slight rash on my stomach that wrapped around my back. After approximately 48 hours all of the symptoms subsided. My blood pressure had returned to normal also. All swelling went down.
62 2021-03-20 migraine Migraine type headache lasted most of day greater than 12 hours, slight fever 1 degree, chills, ache... Read more
Migraine type headache lasted most of day greater than 12 hours, slight fever 1 degree, chills, ache, lower back pain.
62 2021-03-21 weakness Diarrhea, Nausea, Extremely low energy for the course of a day and a half.
62 2021-03-23 feeling cold, cold extremities Extreme tiredness starting at about 3 hours after the vaccination. Then about 8 hours after the vac... Read more
Extreme tiredness starting at about 3 hours after the vaccination. Then about 8 hours after the vaccination got really cold, freezing, unlike another coldness I've felt. Feet and toes were especially cold to the touch. Shivering, heart palpitations too. Bloating and stomach ache and nausea. Tiredness continues the day after (today)
62 2021-03-23 tremor Patient experienced lightheadedness, spots in vision, and shakiness approximately 30 mins after rece... Read more
Patient experienced lightheadedness, spots in vision, and shakiness approximately 30 mins after receiving the vaccine. Was monitored for 25 mins with no resolution in symptoms and was sent to the emergency room for additional evaluation.
62 2021-03-24 breast pain Starting midday Sunday ( one day after vaccine) I started feeling nauseous and about 2:00 I started ... Read more
Starting midday Sunday ( one day after vaccine) I started feeling nauseous and about 2:00 I started throwing up. I threw up until about midnight for a total of 7 times. The night before I had difficulty sleeping. The next morning I felt nauseous again and threw up about 10:00 a.m. I started having diarrhea which has lasted through today (Thursday) and I had lost over 5 pounds in just 3 days and my weight is still over 5 pounds less today because it is difficult to eat much. Sunday I was feeling pain around my lest breast where I had had my mastectomy in June of 2006. That eased up the next day. Feeling stressed because I have bad tinnitus and was worried about a reaction.
62 2021-03-24 pain in extremity Day 11 .. right arm .. red splotchy rash, hot to the touch "Covid Arm" No prior symptoms other than... Read more
Day 11 .. right arm .. red splotchy rash, hot to the touch "Covid Arm" No prior symptoms other than sore arm.
62 2021-03-25 weakness I just started having problems breathing, I couldn't catch my breathe and heart rate went sky high. ... Read more
I just started having problems breathing, I couldn't catch my breathe and heart rate went sky high. I ended up going to the ER, they have me some steroids and breathing treatments, monitored my heart rate for three hours. I stayed in the ER for 4 hours and discharged me. The next day I was feeling a little week but breathing better and heart rate was back down to normal. I have a cough that's lingering a dry cough.
62 2021-03-25 pain in extremity Systemic: tooth sensitivity, could not eat or chew-Severe, Systemic: Joint Pain-Medium, Additional D... Read more
Systemic: tooth sensitivity, could not eat or chew-Severe, Systemic: Joint Pain-Medium, Additional Details: 3/19/21: after work, patient came home and noticed itchy rashes on both ankles\r\n3/20/21: Overnight, patient experienced tooth sensitivity, uncomfortable and painful to chew/eat. 1 top and 1 bottom teeth affected more than the others. Experienced joint pain in hips, hands, and ankles. Patient had history of arthritis\r\n3/21/21: Joint pain continued. Rash on R ankle had a few tiny blisters\r\n3/22/21: Dentist appt where one tooth was extracted. amox & pain med started, rash and pain went away
62 2021-03-27 weakness Pt states approx 10 min after injection started with a headache and dizziness. Pt ate something arou... Read more
Pt states approx 10 min after injection started with a headache and dizziness. Pt ate something around 0900. Patient was given a granola bar and water. at 1405 BP 171/90, HR 83, SP02 98%, RR 16. Pt states heart is "fluttery", pulse regular. 1416 pt states headache is better. pt denies chest pain or SOB. After sitting up from laying position pt states she was dizzier, repeated BP at 1427, no improvement. Gave pt juice b/c she felt shaky and thinks it's because she hasn't eaten. Had pt rest for 10-20 mins more and then obtained orthostatic vitals, no concern for orthostatic HTN, pt states she no longer has headache or is dizzy. Per pt's visitor her color had returned to normal, pt still feels a little shaky. Pt rested another 5 mins, repeated vitals and pts BP was elevated. Discussed with pt and visitor that due to her hx of HTN and her already being on BP meds, pt should be seen in ER and EMS called. Explained that she should have an EKG done b/c of flutters and HTN along with headache. Educated pt on importance of being seen in ED. Gave pt and visitor time to discuss suggestion, when returning pt states, "Talked to niece who is EMT and said I should be fine if I just went home, rested, ate, and checked BP and took another BP pill (1/2) like suggested with doc before getting ahold of physician. All they'll do in ED is continue to check BP". Advised pt that ED would do more than that. Pt refused EMS and wished to go home. Pt visitor stated that they would watch patient and if anything changed take to ED. Patient left clinic in wheelchair and assisted to vehicle. Pt denies any symptoms that she initially presented with but states she just feeling weak.
62 2021-03-29 tingling left arm tingling, dizziness, lightheadedness, nausea, tachycardia, hypertension
62 2021-03-31 flushing Heart racing, flushing
62 2021-04-01 feeling cold, tremor Around 6pm that day I had trembles very bad started getting n feeling cold could not get warm by the... Read more
Around 6pm that day I had trembles very bad started getting n feeling cold could not get warm by the time I came back home I went to bed with all my cloths on and 2 more blankets I had a fever of 103 and was very hot to touch the shakes would not go away. The next day I started feeling a little better still cold and had a very sore throat and runny nose body ached bad very bad friday I feel better but feel like I was hit by a truck
62 2021-04-02 weakness Fever 100 Severe chills Muscle bone pain Severe weakness
62 2021-04-02 migraine Migraine, site soreness and ache up the neck on the same side.
62 2021-04-04 weakness 8 pm- fatigue, beginning of headache. 11 pm chills and fever 1 pm body ached and crushing headache.... Read more
8 pm- fatigue, beginning of headache. 11 pm chills and fever 1 pm body ached and crushing headache. did not sleep. fever went away after 3-4 hours, body aches dissipated over 2nd day, headache lasted until 3rd morning. woke up Sunday feeling tired but headache all but gone. now 3 days later, still have fatigue and a little fogginess. much like when I get over the flu- just weak and tired.
62 2021-04-04 tremor INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; SHAKING; BODY ACHES; SERIOUS DIZZINESS... Read more
INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; SHAKING; BODY ACHES; SERIOUS DIZZINESS; CHILLS; TIREDNESS; HEADACHE; .This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 110 kilograms, and height was 162.56 centimeters. The patient's concurrent conditions included non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergy. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: UNKNOWN) dose was not reported, administered on 07-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vitamins nos. On MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced inappropriate route of vaccine administration. On 07-MAR-2021, the subject experienced off label use. On 07-MAR-2021, the subject experienced shaking. On 07-MAR-2021, the subject experienced body aches. On 07-MAR-2021, the subject experienced serious dizziness. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, body aches, serious dizziness, chills, and tiredness on 14-MAR-2021, and the outcome of headache, inappropriate route of vaccine administration and off label use was not reported. This report was non-serious.; Sender's Comments: V2: Medical assessment comment not required as per the standard operating procedure as the case is assessed as non-serious.
62 2021-04-05 facial pain fever, chills, fatigue, jaw and face pain. Took Tylenol and slept, feeling better 12 hours later
62 2021-04-05 nerve pain, pain in extremity Arm became sore on the left arm - I had a lump and my whole arm was like one giant bruise. That last... Read more
Arm became sore on the left arm - I had a lump and my whole arm was like one giant bruise. That lasted about three weeks. I still have a lump but it isn't bruised looking anymore. The incident I went to medical care for - I saw the doctor on 4/2/2021 and he diagnosed I have shingles on my right leg. I thought it was spider bites. I did have the shingles vaccine. It is inflamed and I get nerve pain down my leg. It is very, very sore to the touch. Right now it is kind of dry - like blisters on it. It's a mild case. Doctor put me on Valacyclovir. He put me on it for one week and I have two more days after today.
62 2021-04-05 pain in extremity, tremor Fatique, Neck tightness, Chills, Fever 102.3, bone pain fingers/hands, shaking legs, unstable walki... Read more
Fatique, Neck tightness, Chills, Fever 102.3, bone pain fingers/hands, shaking legs, unstable walking.
62 2021-04-07 weakness Began with muscles in legs aching, then a headache, body aches, feeling of being sick, chills. Star... Read more
Began with muscles in legs aching, then a headache, body aches, feeling of being sick, chills. Started feeling better two days after shot, but still weak.
62 2021-04-07 bell's palsy, facial paralysis Bell's palsy: left facial droop started the following morning around 8AM
62 2021-04-07 discomfort, feeling cold I got the vaccine at around 11am on 6th April. By 8pm the same day I was experiencing very severe c... Read more
I got the vaccine at around 11am on 6th April. By 8pm the same day I was experiencing very severe chills - I have never felt so cold before in my life, and the evening was not cold.. The next day, 7th April, I woke up with bad aches in various, seemingly random areas of my body: both upper arms, outside parts of both thighs, center of back between shoulder blades. Interestingly all the aches were symmetrical. I had not done any serious exercise to cause these symptoms, just a stroll around the park after getting the vaccine. I also experienced crushing tiredness and had to go back to bed in the afternoon. Today, 8th April at 5:30 pm my left arm at the vaccine site still aches, but all the other symptoms had vanished by the morning. I'm 5' 4" and weigh 114lbs. My husband got the vaccine at the same time and had no symptoms. We are speculating that my smaller size may have contributed to my adverse reaction. He is 5' 6" and weighs 180lbs. In spite of this discomfort I'm so relieved and pleased that we were able to get the vaccine. Thank you!
62 2021-04-07 feeling cold, weakness Janssen COVID-19 Vaccine EUA Severe joint and muscle pain all over the body starting at 7:30 pm. Pro... Read more
Janssen COVID-19 Vaccine EUA Severe joint and muscle pain all over the body starting at 7:30 pm. Progressively worsening overnight. Overall weakness, cold shivers, severe palpitations with 136 heart rate in resting position. Initially decreased temperature and then increased temperature to 101. Tramadol for pain and diazepan for sleep taken at night. Felt better by the next day afternoon.
62 2021-04-07 feeling cold, cold sweat Client received the COVID vaccine (Janssen, Lot# 1808980) at 11:30. EMT observed the client sitting ... Read more
Client received the COVID vaccine (Janssen, Lot# 1808980) at 11:30. EMT observed the client sitting with her head in her hands and alerted RN, then all responded at 1140. The client complained of shortness of breath and dizziness. Upon assessment, the client was pale, diaphoretic, and clammy, and her skin was cool and dry. The client stated that she is anxious about needles and vaccinations, and that her mask was making her feel "claustrophobic." The client was encouraged to practice deep breathing and her vital signs were obtained: blood pressure of 96/76, respiratory rate of 12. The client stated that she did eat breakfast that morning at 0930 and was offered some water to drink. . Per the client, she has a medical history of hypothyroidism and the only medication she takes is levothyroxine. The client also stated that she tends to have lower blood pressure and "110/60 is normal" for her. The client was alert and oriented. At 1145, the repeat vital blood pressure for the client was 97/63. She stated at this time that she felt like she was going to pass out, and was transferred to the reclining chair. At 1150, the repeat vital signs were as follows: blood pressure of 118/80, heart rate of 78, respiratory rate of 16, and pulse O2 reading of 95%. At 1155, repeat vital signs were as follows: blood pressure of 112/74, heart rate of 78, respiratory rate of 14, pulse oximeter reading of 96%. At this time, the client's color returned to normal and they were no longer clammy. At 1207, the client's blood pressure was 110/72, their heart rate was 73, their respiratory rate was 8, and their pulse oximeter reading was 97%. The client stated they "feel great" and left the facility at 1210, ambulating with a steady gait to their car, where they were driven home by an acquaintance.
62 2021-04-07 pain in extremity Initial reaction was flu-like symptoms but more concerning reaction was a bad rash with red small bu... Read more
Initial reaction was flu-like symptoms but more concerning reaction was a bad rash with red small bumps on the same side as the shot was given directly above my left breast that was severely itchy. This rash is just now starting to dissipate but still itches; I used OTC cortisone creme and Benedryl to address the itching. The other major effect involved my left arm. For a full week, the muscle in which the shot was given was extremely sore to the touch and the whole arm ached. I still cannot fully extend that arm above my head without it feeling like an aching weight. Lastly, I had a pain in the center of my back as a hard ache that one week later still has not fully dissipated. It appears to be going away, but has lingered longer than I would have expected.
62 2021-04-08 cold sweat, feeling cold, weakness, tremor Four days after I received the vaccine (this week Tuesday), I suddenly felt very dizzy and faintish.... Read more
Four days after I received the vaccine (this week Tuesday), I suddenly felt very dizzy and faintish. I sat down until the dizzy spell passed. I felt very cold and clammy and nauseous. My hands were very shaky. I felt very weak and very tired so I slept the whole day. Today I woke up and felt the same dizziness, very cold hands and nauseous. Both times I had diarrhea. I have never had dizzy spells before so I know this has to be vaccine related.
62 2021-04-08 migraine migraine Headache BP 235/110 was getting dizzy, tongue became numb she went to nurse 911 called. s... Read more
migraine Headache BP 235/110 was getting dizzy, tongue became numb she went to nurse 911 called. she was uncomfortable taking vaccination, For 30 minutes she was ok- tongue numb lips swollen still has migraine TMJ pains Did not get epinephrine. BP is on the "high normal side" 140/90, did not check pulse Oxygen level No rash
62 2021-04-08 tremor Six hours after the vaccine, I had the chills that quickly turned into UNCONTROLLABLE & SEVERE body ... Read more
Six hours after the vaccine, I had the chills that quickly turned into UNCONTROLLABLE & SEVERE body shaking, a headache, SEVERE back and neck pain and elevated resting heart rate (96). I took 2.5mg of Ambian thinking that if I could just fall asleep, I would sleep it off. After an hour of non-stop symptoms, I fell asleep for about an hour only to wake up with the severe neck and back pain and headache still present. The body shaking had subsided. The next day, I was tired but fine.
62 2021-04-09 weakness, pain in extremity This spontaneous report received from a patient concerned a 62 year old female. The patient's height... Read more
This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced tiredness. On 01-APR-2021, the subject experienced subject could not lift things (strength loss). On 01-APR-2021, the subject experienced pain in arm. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on APR-2021, and had not recovered from muscle ache, pain in arm, patient could not lift things (strength loss), and tiredness. This report was non-serious.
62 2021-04-09 weakness 8 hrs after vaccine had fever if 104 and pulse of 125. Very weak and dizzy. This continued until the... Read more
8 hrs after vaccine had fever if 104 and pulse of 125. Very weak and dizzy. This continued until the next morning.Took 1300 MG acetaminophen. Had no effect. Used ice bags, had no effect.
62 2021-04-09 weakness A couple minutes after receiving the vaccine, patient started feeling dizzy and described it as her ... Read more
A couple minutes after receiving the vaccine, patient started feeling dizzy and described it as her head feeling heavy, and some weakness. She was offered water and was brought in to the clinic for further monitoring. BP- 164/78. PR- 71. Symptoms did not worsen and it improved after 1 hour, but not totally resolved. BP recheck was 143/62. PR- 76. Patient said she felt better and volunteered to go home. Instructed to go to ER if her symptoms persist and worsen; patient verbalized understanding. Discharged to home after an hour of monitoring.
62 2021-04-09 weakness A few hours after receiving the "Janssen COVID-19 Vaccine EUA" I started to experience the following... Read more
A few hours after receiving the "Janssen COVID-19 Vaccine EUA" I started to experience the following side-effects: headache, fever, muscle aches, tired and weakness. I also felt a little dizzie. I monitored my temperature thoughout the night; I recorded at 7:54pm 99.7; 9:23pm 99.2; 10:45pm 99.8; and at 6:00 am on 4/9 my temperature was back to normal at 97.5. The muscle ache were gone and the headache was mild. I do still feel a little dizzie and weak.
62 2021-04-09 burning sensation, weakness, tremor Shortness of breath, difficulty breathing, difficulty speaking, chills, violent shaking, left kidney... Read more
Shortness of breath, difficulty breathing, difficulty speaking, chills, violent shaking, left kidney pain , headache, Coughing body aches, fatigue, confusion, difficulty sleeping ,loss of appetite, weakness , burning in my lungs
62 2021-04-09 cold sweat, pain in extremity, tingling, tremor 03/08/2021 (Symptoms began 45 minutes after shot): sore arm down to fingers, stuffy nose, watery eye... Read more
03/08/2021 (Symptoms began 45 minutes after shot): sore arm down to fingers, stuffy nose, watery eyes, headache, light headed, slight balance issues, malaise, no appetite, slight nausea, tight chest, arm soreness down to fingers became worst & was accompanied by arm swelling which included the fingers, 2 hives, tingle around mouth & nose, asthma feeling progressed to shortness of breath upon exertion, slight face swelling, Temp 102, chills. 03/09/2021 same symptoms as 03/08/2021 but minus the hives & the addition of the following symptoms: Temp 101, shaking so bad from chills couldn't hold anything, runny nose & eyes, extreme fatigue, small chest pain, skin cold like had been in freezer, lips & fingers slightly purple. 03/10/2021 same symptoms as 03/08/2021 & 03/09/2021 but minus the hives, slight face swelling, servere chills, lips & fingers barely purple & the addition of the following symptoms: Temp 100. 03/11/2021 symptoms include: Temp 99.7, sore arm down to fingers, stuffy nose, watery eyes, headache, slight balance issues, malaise, no appetite, slight nausea, tight chest, shortness of breath upon exertion, runny nose & eyes, extreme fatigue, & small chest pain. 03/12/2021 symptoms include: Temp 98.7, sore arm down to fingers, slight headache, slight balance issues, malaise, no appetite, slight nausea, slight tight chest, shortness of breath upon exertion, runny nose & eyes, extreme fatigue. 03/13/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, no appetite, slight nausea, slight tight chest, slight shortness of breath upon exertion, runny nose & eyes, extreme fatigue. 03/14/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, slight appetite, slight nausea, slight tight chest, slight runny nose & eyes, extreme fatigue. 03/15/2021 symptoms include: Temp 97.7 (my normal), sore arm down to fingers, malaise, slight tight chest, slight runny nose & eyes, extreme fatigue. 03/15/2021- 04/10/2021 symptoms include: Temp 97.7 (my normal), fatigue & slight malaise at times.
62 2021-04-09 feeling hot At time of the shot, bright red face, rash, skin warm to touch. In the early evening chills, dizzy, ... Read more
At time of the shot, bright red face, rash, skin warm to touch. In the early evening chills, dizzy, waves of nausea. In the morning: vomit, nausea, chills, headache, dizzy
62 2021-04-09 numbness Numbness on left side of face lasting from 3pm to after midnight on 3/8/21. It subsided on 3/9/21 d... Read more
Numbness on left side of face lasting from 3pm to after midnight on 3/8/21. It subsided on 3/9/21 during the day, but again felt numbness on left side of face at 10:00pm on 3/9/21. Continue to feel nausea, no appetite, and extreme fatigue.
62 2021-04-10 pain in extremity, hot flush Experienced all common symptoms as well as other I have not heard of. Mental fogginess began at 8 PM... Read more
Experienced all common symptoms as well as other I have not heard of. Mental fogginess began at 8 PM (8 hrs after shot) and lasted until late the next evening Chills began at 8:30 PM and continued until early Friday AM. There were also a few instances of hot flashes in between the chills. About 10 hours after the shot the following began: headache (I rarely get headaches), nausea, muscle aches - mostly my quadriceps, low back pain, pain in the back of my neck, general lethargic feeling. These all lasted into Thursday evening, except the low back pain, which lasted into Friday AM. I felt a dull pain in all my back teeth that lasted about a day and was intermittent. See page 2 for more.
62 2021-04-10 tremor, weakness Fever (102.9), intense chills - trembling, teeth chattering. Also severe weakness and aches.
62 2021-04-11 weakness Nausea, Bloating, slight head ache , blurred vision, weakness, no energy.
62 2021-04-11 feeling hot WARMTH; ACHINESS; CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a 62 ... Read more
WARMTH; ACHINESS; CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a 62 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: not reported) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced warmth. On 06-APR-2021, the subject experienced achiness. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, warmth, headache, and achiness. This report was non-serious. This case, from the same reporter is linked to 20210413415.
62 2021-04-11 hot flush beginning the following morning: hot flash followed by chills followed by vomiting. Hot flashes, Ch... Read more
beginning the following morning: hot flash followed by chills followed by vomiting. Hot flashes, Chills, Nausea, Vomiting, Diarrhea continued for 48 hours
62 2021-04-11 muscle spasms Same night of the vaccine I had fevers & chills. They were gone after 12 hrs. On 3/18/2021 I stated ... Read more
Same night of the vaccine I had fevers & chills. They were gone after 12 hrs. On 3/18/2021 I stated having stomach problems. I had diarrhea & cramping this was going on & off. Around one week later I went to urgent care because of how much I was cramping. I followed up with my regular doctor & he did some la work. It kept going on & off but it started getting better & today on 4/12/2021 is the first day I started feeling like myself.
62 2021-04-11 pain in extremity Pain of lower extremities; SHORTNESS OF BREATH; WEAKNESS OF THE UPPER ARMS; WEAKNESS OF LEGS; Chills... Read more
Pain of lower extremities; SHORTNESS OF BREATH; WEAKNESS OF THE UPPER ARMS; WEAKNESS OF LEGS; Chills; Fever; VIBRATION SENSE ON BOTH LEGS; Chest tightness; STIFFNESS/TIGHTNESS OF LEGS; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced vibration sense on both legs. On 09-MAR-2021, the subject experienced chest tightness. On 09-MAR-2021, the subject experienced stiffness/tightness of legs. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 16-MAR-2021, the subject experienced weakness of legs. On 23-MAR-2021, the subject experienced weakness of the upper arms. On 04-APR-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced pain of lower extremities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, chills, and fever on 10-MAR-2021, and had not recovered from vibration sense on both legs, shortness of breath, weakness of legs, weakness of the upper arms, stiffness/tightness of legs, and pain of lower extremities. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as Non serious.
62 2021-04-11 tremor 2 hours after I received the vaccination, I came down with severe chills. My entire body was shakin... Read more
2 hours after I received the vaccination, I came down with severe chills. My entire body was shaking and I could not get warm. I got extremely fatigued to the point that I could not get out of bed. I got a severe headache (and I get headaches a lot...this one lasted for almost 10 days). It seemed that every bone and muscle in my body began aching, from head to toes. My fever went up to almost 102. These symptoms continued for a course of four days, except the headache and fatigue (which lasted for approximately 6 days and the headache for 10 days). I alternated Tylenol, Advil and Alleve. They did not help hardly at all, unfortunately. 2 weeks later, I developed lymph node swelling in my right arm pit and alongside my right breast. Today, these lymph nodes are still swollen and are painful to the touch. I experienced pain at the injection site and if I touch it, it is still painful today, but does not ache like it did initially.
62 2021-04-12 feeling hot Feeling glooomy snd a little foggy in the head since day one. Tightness in my leggs thighs. Feeling... Read more
Feeling glooomy snd a little foggy in the head since day one. Tightness in my leggs thighs. Feeling warm not fever. Not as much on day 7
62 2021-04-12 muscle spasms Headache. Chest pain Muscle cramps. Fever
62 2021-04-12 pain in extremity Chills, severe aches, pain in my left arm down to my hand , neck, back, chest, keytones due to type ... Read more
Chills, severe aches, pain in my left arm down to my hand , neck, back, chest, keytones due to type 1 diabetes.
62 2021-04-12 pain in extremity I started having pain in my left calf on Sunday 4/11/2021. I went to the doctor on the next day, Mon... Read more
I started having pain in my left calf on Sunday 4/11/2021. I went to the doctor on the next day, Monday, April 12 at 9am. He sent me to the center where they did an Ultrasound which was positive . I was adviced to go to the Hospital for a CT scan of my lungs and brain. I went to medical center on Monday at 6pm. There I was given an Iodine CT scan. They noticed a small spot of pneumonia. They repeated the Ultrasound of my leg and took a swab for Covid-19. I was given a prescription for Xarelto and an antibiotic , Levaquin, 500mg.. I came home.
62 2021-04-12 tingling Pt was vaccinated at 1630 and then proceeded to the monitoring area for her 30 minutes due to allerg... Read more
Pt was vaccinated at 1630 and then proceeded to the monitoring area for her 30 minutes due to allergy hx. At 1700 pt started to c/o to monitoring RN that she felt tingling in her both her arms and legs. RN provided pt wit diphenhydramine 25mg PO with water. Pt continued to be monitored. No additional s/s of an allergic rxn were noted. Tingling improved and pt was discharged home with son at 1720.
62 2021-04-13 weakness, feeling jittery Got shot a little after 3 pm March 11, 2021. At about 10 pm that evening, had about an hour of chill... Read more
Got shot a little after 3 pm March 11, 2021. At about 10 pm that evening, had about an hour of chills, no big deal. Then began to get headache with slight fever and the headache got progressively worse, with nausea and rapid heart rate. The headache was so bad I could not sleep at all - the worst headache I have ever had. I took one extra-strength Tylenol at about 10 or 11 am the next day, March 12, which took the edge off the headache. The headache diminished till it was gone by about 8 or 9 pm. The rapid heart rate, along with tiredness, low energy, and feeling jittery continued for several days, then stopped. About 3 or 4 weeks later...there's more BUT FORM WON'T LET ME GO TO CONTINUATION PAGE
62 2021-04-13 burning sensation Some minutes after the injection I started feeling a burning sensation under my bra (around my chest... Read more
Some minutes after the injection I started feeling a burning sensation under my bra (around my chest), and it was hard to breath and then I started feeling it in my throat and then my lips started tingling, I also had a headache that started. I alerted the person at the vaccination site saying something was not right and then they called the paramedics who took my vitals and said my heart rate and blood pressure was extremely high. They gave me a shot of Benadryl and oxygen because I was feeling shortness of breath. They kept me until about 11:35 in observation when I felt myself again. The headache, nausea and body aches stayed for about 2 weeks but all other symptoms subsided.
62 2021-04-13 flushing Severe nausea, syncope, flushing of face and upper body
62 2021-04-13 flushing Within 15 minutes of receiving vaccine, massive headache, slight nausea, flushing of face, rapid hea... Read more
Within 15 minutes of receiving vaccine, massive headache, slight nausea, flushing of face, rapid heart rate double the normal heart rate for myself (120 beats per minute, as opposed to 60 BPM), heat in right hand. Adverse effects lasted 20 hours after injection. Slight headache on and off from 4/11/2021 to 4/14/2021. Also noted jaw pain, felt like slight swelling around eustachian tubes of both ears.
62 2021-04-13 numbness, weakness, burning sensation She received the Johnson & Johnson COVID Vaccine 3/5/2021 9:30am. 3/6/2021 She reports that she wa... Read more
She received the Johnson & Johnson COVID Vaccine 3/5/2021 9:30am. 3/6/2021 She reports that she was weak and exhausted and flu like symptoms. Symptoms began on 3/7/21, woke up horizontal binocular diplopia at 8:30am. Has been constant since it started. It is worst when looking to the left and best looking the right. Worse in the distance. No other associated symptoms 3/13/21: Around noon, was just sitting in the chair. She reports that she got a bad headache and then the entire left side of the body from head to toe was numb and burning in the left side face. This lasted all day, but completely resolved by night time. Had never had anything quite like that in the past. She had a headache that started soon before the numbness, that also lasted most of the day. 3/15/21: was seen in ED with reported normal MRI, CT, and EKG MRI brain with a small left pons lesion near the cranial nerve 6 nucleus She was seen by Neuro-ophthalmology Dr. (attending), Dr. (fellow) 3/17/2021 " MRI brain on 3/15/21 did not reveal a structural etiology for diplopia. Differential diagnosis includes microvascular ischemic left 6th nerve palsy versus possibly post-vaccination cranial nerve palsy (received COVID vaccine 2 days prior). Also on the differential diagnosis but less likely, includes myasthenia gravis (she did not have expected abduction saccade slowing of the left eye typical of an ischemic cranial nerve palsy). Thyroid eye disease also would be less likely. We will obtain antibody testing for myasthenia and thyroid eye disease. Today we applied a 10 prism diopter base out prism over her left glasses lens. I instructed her to remove this when appropriate, as I expect her diplopia to gradually improved." 4/7/2021 acetylcholine ab receptor negative, TSI negative, TSH receptor antibody negative, LH/FSH normal,
62 2021-04-13 migraine Onset of dull headache which worsened. Continued worsening into a massive migraine(cluster, light se... Read more
Onset of dull headache which worsened. Continued worsening into a massive migraine(cluster, light sensitive). After several hours I took a migraine relief OTC medication. The headache subsided with minor headache into the following day.
62 2021-04-13 migraine received Jansen vaccine on 3/31/21 and the following day I had a headache,, achy and tired. I expec... Read more
received Jansen vaccine on 3/31/21 and the following day I had a headache,, achy and tired. I expected this, but a few days later I was still having what I describe as migraine type headaches and at one point I was sweating profusely, dizzy massive headache with not only nausea, but dry heaving so bad I could barely get to my medication and seriously thought it would never subside. I continued with headaches up until today April 14. This is the first day I have not had a headache. I contacted my vascular doctor as I had a blood clot several years ago and he has prescribed Eliquis twice a day for the next 2 weeks. Today marks 2 weeks and like I said, it's the first day I have not had a headache
62 2021-04-13 muscle spasms According to the patiens, she had hives and echiness the next day after receiving the vaccination. T... Read more
According to the patiens, she had hives and echiness the next day after receiving the vaccination. Today the 14th of April, she showed up to the pharmacy and complained of severe leg cramps and multiple bruises in her legs and thighs. I advised her to go to the emergency room. She picked up her aspirin 81 mg .
62 2021-04-13 pain in extremity, weakness Leg Pain: Bilateral; heavy and achy especially to lower legs. Having generalized weakness and lack o... Read more
Leg Pain: Bilateral; heavy and achy especially to lower legs. Having generalized weakness and lack of energy. Associated sx: sob with rest/exertion; worse with exertion and dry cough. Onset of sx over Easter weekend and continued without improvement. Reports she had her COVID19 Vaccine (J&J, March 20). Onset of sx approximately 15 days from J&J COVID vaccine. Further c/o increased edema to BLE. Usually wears her stockings but cannot tolerate them d/t pain. Reports family hx of CHF in mom. She further has a hx of varicose veins. Tx: labs and imaging - see below.
62 2021-04-13 pain in extremity 4-10 and 4-11 experienced leg pain in left calf. When laying in bed moved up back of upper leg. Tyle... Read more
4-10 and 4-11 experienced leg pain in left calf. When laying in bed moved up back of upper leg. Tylenol helped but only 3 hours. Took ibuprofen next nigh, helped overnight. Symptoms resolved by morning.
62 2021-04-13 pain in extremity 4/14/21 Per Patient, received Janssen vaccine on 3/5/2021, began experiencing headaches on side of f... Read more
4/14/21 Per Patient, received Janssen vaccine on 3/5/2021, began experiencing headaches on side of face and intermittent sharp left leg pain 3/12/2021, does not usually get headaches and thought related to dental work, 4 tooth implants, evaluated by dentist who said headaches not related to dental work, had been more active, walking with nice weather and thought leg pain might be caused by tick bite, left knee "gave out", husband looked at back of leg and did not see any evidence of tick bite, noticed varicose veins had worsened (more prominent, not red or swollen) and thought should be checked, appointment at center 4/8/21 and is under the care of Dr, has follow up appointment 4/21/2021. Placed on blood thinner Xarelto 15 mg tablets, 2 tablets daily x 21 days, then reduced to 1 tablet daily x 22 days for blood clots. Headaches and leg pain improved after starting medication. Signed up for program 4/13/21 after suggested by daughter.
62 2021-04-13 pain in extremity Very lightheaded while vaccine was injected into my arm. It has never happened with other vaccines.... Read more
Very lightheaded while vaccine was injected into my arm. It has never happened with other vaccines. Once needle was pulled out of arm, was not lightheaded anymore. Also muscle in my arm is sore 1 month later and not getting better yet.
62 2021-04-13 sciatica, pain in extremity Swelling of the lymph nodes in the same arm of the injection for 3 days, used heating pad to sooth. ... Read more
Swelling of the lymph nodes in the same arm of the injection for 3 days, used heating pad to sooth. Pain at the injection site for 2 days, used CBD oil around site of injection to sooth. headache, feeling very tired, muscle aches , chills and joint pain for 4 or 5 days. I took 2 Tylenol 325mg 2 different times. I already take Mobic for a slipped disc. Had just had a L3-L4 dorsal epidural steroid injection on 2/25/21. It negated the medicine. My sciatic leg pain is back in full force. I called my PCM for advice. They suggested I inform you.
62 2021-04-13 unresponsive to stimuli, seizure like phenomena 12-24 hours after the Covid -19 vaccine the patient had a seizure like event: eyes wide open, moanin... Read more
12-24 hours after the Covid -19 vaccine the patient had a seizure like event: eyes wide open, moaning, unresponsive for 2-3 mins. Patient had reported occurences of blacking out. These are new events. The patient does not have any history of seizures or seizure like symptoms. Patient was placed in isolation at the hospitial for 03/13/2021 thru 03/16/2021
62 2021-04-14 inability to speak, tremor, tingling, numbness, slurring 10 minutes after shot i started to feel tingling and numbness in my chest which traveled to my neck ... Read more
10 minutes after shot i started to feel tingling and numbness in my chest which traveled to my neck and into face. Began having a dry cough, went to nurse to as if normal, she said no, she started monitoring me. Still had cough, then became light headed and nausea. She gave me 25 mg of Benadryl, coughing continued, breathing became rapid, then I was given shot of epi, I became dizzy again and couldn?t complete a sentence. Words were slurred, heart beat racing. EMT?s were called. Received another shot of Benadryl. It did not counteract anything. Received another shot of epi. Had uncontrollable shakes and hard to breathe or speak. Was difficult to get BP reading due to shaking. Finally got reading of 196/99. EMT listened to heart and lungs. Said all was good. Taken to ER for monitoring of heart, Lungs and BP. Was there for approximately 2 hours u til shakes and BP were good.
62 2021-04-14 burning sensation Sore arm at injection site and then a couple hours later started with fever, then red rash over top ... Read more
Sore arm at injection site and then a couple hours later started with fever, then red rash over top of body chest, arms rash felt like a burn, nausea, diarrhea, body aches all over, slight headache, tired- took tylenol ever four hours. Rash lasted until Sunday early evening, headache until Sunday morning, tired and aches lasted until Tuesday. Nausea and diarrhea on and off until Tuesday. Fever until Sunday afternoon. Pain in back rt side. About 1 hour after vaccine - chest tightness felt like asthma coming on, then it went away.
62 2021-04-14 feeling jittery Initial reaction was noted on 8:00 PM 3/17. Jitteriness and fatigue on 3/17. Around 9:00 felt neck ... Read more
Initial reaction was noted on 8:00 PM 3/17. Jitteriness and fatigue on 3/17. Around 9:00 felt neck pain and it was hard to move her neck. The neck pain was severe 10/10. Still has problems with the neck. Her neck pain has improved but the pain is worse than it was before she had the vaccine.
62 2021-04-14 severe one side paralysis I called a message that patient had experienced a stroke recently and had also rececived the Jansson... Read more
I called a message that patient had experienced a stroke recently and had also rececived the Jansson vaccine. I called patient, who had reported that it happened on 4/2. She had woke up and couldn't put her robe on. Her left arm was not working right. She also noted that she had drooled. She kept thinking that she was find and got ready and went to work. During work she was typing and found that her left hand was not working still, but still went throughout her day and typed with her right hand. Later that evening when she got home, her husband took her to the ER. There, she reports that her blood pressure was through the roof. She had a CT scan and MRI and labs done and was diagnosed with a TIA. She was started on Plavix, baby aspirin, and was started on a statin drug (couldn't remember the name as that information was at home and she was at work at time of call). She is on a heart monitor for 4 weeks and has follow ups with her outside PCP and cardiologist. Today she states that she is feeling back to normal and has regained function on her left side. She reports that she had a headache at time that had lasted for a while. She also reports that she feels like she was having issues weeks before because her brain felt foggy and just was not thinking right.
62 2021-04-14 muscle spasms, tenderness, pain in extremity The day after having been vaccinated with Johnson & Johnson/Janssen COVID19 vaccine (04/11/2021), m... Read more
The day after having been vaccinated with Johnson & Johnson/Janssen COVID19 vaccine (04/11/2021), my mother started to feel intense pain, swelling, tenderness and cramping in her legs, especially her right leg, to the point that she couldn't walk. By the fourth day after the vaccine her right leg was completely swollen, twice as big as its normal size, the pain was unbearable and she experienced fatigue and shortness of breath. I took her to the ER on 04/14/2021
62 2021-04-15 weakness CHILLS; FEVER; MUSCLE ACHES; FEELING TIRED; FEELING WEAK; This spontaneous report received from a pa... Read more
CHILLS; FEVER; MUSCLE ACHES; FEELING TIRED; FEELING WEAK; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included lung transplant, and liver transplant, and concurrent conditions included hepatitis c. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced feeling tired. On 08-APR-2021, the subject experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-APR-2021, and had not recovered from muscle aches, feeling tired, and feeling weak. This report was non-serious.
62 2021-04-15 weakness Dizziness approx. 30 minutes after vaccination, spinning sensation 1hr after vaccination. Chills and... Read more
Dizziness approx. 30 minutes after vaccination, spinning sensation 1hr after vaccination. Chills and shivering approx. 5 hrs after-- nausea-vomiting-102 fever, severe muscle, joint and headache. 5 1/2 hrs later. 36 hrs after shot side effects lessen. 72 hrs later weakness and fatigue. Day 4 these symptoms resolve. Five days after vaccine dizziness and muffled hearing in left ear which is unresolved.
62 2021-04-15 feeling hot FEELS SPACEY; DIZZINESS; PAIN FROM HEAD TO TOE; NAUSEA; DRY THROAT; EYEBALLS WERE HURTING; FEELING H... Read more
FEELS SPACEY; DIZZINESS; PAIN FROM HEAD TO TOE; NAUSEA; DRY THROAT; EYEBALLS WERE HURTING; FEELING HOT; FELT LIKE RUN OVER BY A MACK TRUCK; CHILLS; HEADACHE; HOT SWEATS; STOMACH ACHE / BELLY MUSCLE ACHE; INCREASED GAS; BURPING; SWOLLEN THROAT; THROAT IRRITATION; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced increased gas. On 07-APR-2021, the subject experienced burping. On 07-APR-2021, the subject experienced swollen throat. On 07-APR-2021, the subject experienced throat irritation. On 08-APR-2021, the subject experienced stomach ache / belly muscle ache. On 08-APR-2021, the subject experienced hot sweats. On 08-APR-2021, the subject experienced dry throat. On 08-APR-2021, the subject experienced eyeballs were hurting. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced felt like run over by a mack truck. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021 03:00, the subject experienced dizziness. On 08-APR-2021 03:00, the subject experienced pain from head to toe. On 08-APR-2021 03:00, the subject experienced nausea. On 09-APR-2021, the subject experienced feels spacey. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach ache / belly muscle ache, increased gas, burping, headache, swollen throat, dizziness, nausea, pain from head to toe, chills, hot sweats, feels spacey, throat irritation, dry throat, eyeballs were hurting, feeling hot, and felt like run over by a mack truck. This report was non-serious.
62 2021-04-15 numbness Dizziness/itching resolved in 30 mins Numbness: left arm and face resolved 4 hrs
62 2021-04-15 numbness Vaccine administered on right arm on 4/8/2021. Approximately, 12 hours later she began experiencing... Read more
Vaccine administered on right arm on 4/8/2021. Approximately, 12 hours later she began experiencing severe abdominal stomach pain, fever and general malaise (fever and malaise have generally resolved), numbness in her left arm, and elevated blood pressure. She continues to have abdominal pain 7 days after immunization. Advised to go to emergency room out of an abundance of precaution.
62 2021-04-15 migraine FLU LIKE SYMPTOMS; SWEATING; BODY ACHE; MIGRAINE/HEADACHE; FATIGUE; NAUSEA; This spontaneous report ... Read more
FLU LIKE SYMPTOMS; SWEATING; BODY ACHE; MIGRAINE/HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included stent in heart, and stent in leg, and concurrent conditions included migraine, high blood pressure, gastroesophageal reflux disease, and irritable bowel, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for gastroesophageal reflux disease, and irritable bowel, hydrochlorothiazide for high blood pressure, lisinopril for high blood pressure, metoprolol succinate for high blood pressure, pantoprazole for irritable bowel, and gastroesophageal reflux disease, butalbital/caffeine/paracetamol for migraine, acetylsalicylic acid for stent placed in heart, and clopidogrel bisulfate for stent placed in heart, and stent in leg. On 05-APR-2021, the subject experienced flu like symptoms. On 05-APR-2021, the subject experienced sweating. On 05-APR-2021, the subject experienced body ache. On 05-APR-2021, the subject experienced migraine/headache. On 05-APR-2021, the subject experienced fatigue. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, sweating, body ache, and migraine/headache on 09-APR-2021, and nausea on 07-APR-2021, and was recovering from fatigue. This report was non-serious.
62 2021-04-15 pain in extremity Patient began to experience upper thigh pain approximately 3/16/2021 - 3/18/2021. Can't remember wh... Read more
Patient began to experience upper thigh pain approximately 3/16/2021 - 3/18/2021. Can't remember which leg, reports the pain as a stabbing and aching pain. Leg was painful whether walking or not. Rates pain 4-5 on the pain scale with 10 being the worst pain ever experienced. Doesn't recall redness, swelling, or warmth to area of the leg. The pain lasted approximately 2-3 days . Patient did not contact her PCP. Also reports headache to back of the head which lasted around one day. Typically has sinus headaches. Recommended she contact PCP immediately so he/she can follow-up
62 2021-04-16 pain in extremity Dizziness, nausea, leg pain(left), migraines, diarrhea (ongoing),chills, unable to regulate body tem... Read more
Dizziness, nausea, leg pain(left), migraines, diarrhea (ongoing),chills, unable to regulate body temperature(ongoing), severe fatigue (also ongoing), difficulty working, inappetince... Spoke with doctor. No help. No treatments.
62 2021-04-18 weakness, muscle spasms I received the Janssen COVAX on Monday morning, 5 Apr 2021. A week later, on Monday evening, 12 Apr... Read more
I received the Janssen COVAX on Monday morning, 5 Apr 2021. A week later, on Monday evening, 12 Apr 2021, I experienced extremely painful leg cramps and broke out in a sweat. I felt extremely nauseous, and weak, this was followed by a sever pain in my head that was so extreme that I passed out. After coming to, the pain in my head finally began to subside, along with the leg cramps. My husband indicated that I was unconscious for just under a minute. For the next two days, I had bouts of nausea, headaches, sweats, and was extremely tired. On Wednesday, 14 Apr, after learning of the issues related to the Janssen vaccine, and the symptoms described being what I experienced, I contacted the advice (cont'd)..Additional information for Item 18: Line and was told to go to Emergency Room at the hospital, which I did. I do not feel that they addressed my concerns or the symptoms that I was experiencing, and at no time did they try to determine if it was due to the vaccine. The discharge papers did not even address the "event" and the "symptoms" that I described. They did not take any information down related to the vaccine, lot number, etc., that I had received. They seemed to go through a set routine: blood pressure, blood work, temperature, EKG, and CAT scan. 21. (continued)...Visited Emergency Room, however, was requested by ER to go to Primary Care as follow-up, however, as a Employee we cannot be seen by Primary Care on THIS site. Instead , we have to go on the local clinic to receive care. The issue is that this was a vaccine that I was scheduled by my leadership to receive, with no choice in choosing which vaccine I could receive, and without follow-up care for adverse reactions. The hospital did not indicate to me that I should report this incident, however, I am concerned as a result of the "event" that I experienced, that it should be reported. Furthermore,we should have a choice as to which vaccine we want to receive, just as everyone does. Your form does not allow for input addresses Also, your form does not allow for a phone number. I am out of the country.
62 2021-04-18 pain in extremity Reports that she starting having leg pain in right leg. States that it starting out intermittent but... Read more
Reports that she starting having leg pain in right leg. States that it starting out intermittent but has gotten worse. Especially at night. Did have some redness to that leg a couple days ago but has resolved.
62 2021-04-18 pain in extremity CHILLS; FEVER; HEADACHE; SORE ARM; This spontaneous report received from a patient concerned a 62 ye... Read more
CHILLS; FEVER; HEADACHE; SORE ARM; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 12:50 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.9 (unit not specified). On 10-MAR-2021 12:50, the subject experienced sore arm. On 10-MAR-2021 22:00, the subject experienced chills. On 10-MAR-2021 22:00, the subject experienced fever. On 10-MAR-2021 22:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 10-MAR-2021 15:50, was recovering from chills, and fever, and had not recovered from headache. This report was non-serious.
62 2021-04-18 pain in extremity Lower Abdominal pain and pain to bilateral upper inner thighs.
62 2021-04-18 pain in extremity NAUSEA; HEADACHE; INJECTION SITE PAIN; BODY ACHE; ARM HURT; CHILLS; JOINT PAIN; MYALGIA; This sponta... Read more
NAUSEA; HEADACHE; INJECTION SITE PAIN; BODY ACHE; ARM HURT; CHILLS; JOINT PAIN; MYALGIA; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 125 pounds, and height was 174 centimeters. The patient's concurrent conditions included no alcohol user, and non smoker. The patient experienced drug allergy when treated with tetracycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: 25/MAY/2021) dose was not reported, administered on 10-MAR-2021 11:00 for prophylactic vaccination. Concomitant medications included ascorbic acid/calcium/minerals nos/retinol/tocopheryl acetate/vitamin b nos/vitamins nos/zinc for drug used for unknown indication, calcium carbonate/colecalciferol for drug used for unknown indication, vitamin c for drug used for unknown indication, alendronate sodium for osteoporosis, nebivolol hydrochloride for slow heart down, aloe vera, and chondroitin sulfate/collagen/glucosamine. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced arm hurt. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced joint pain. On 10-MAR-2021, the subject experienced myalgia. On 10-MAR-2021 15:00, the subject experienced nausea. On 10-MAR-2021 12:30, the subject experienced headache. On 10-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, arm hurt, chills, myalgia, nausea, joint pain, and injection site pain. and headache on 11-MAR-2021 This report was non-serious.
62 2021-04-19 weakness I?m sick weak headaches chills ... dizzy loud ringing in ears . I?ve never been so sick in my life
62 2021-04-19 weakness 2 hours after receiving the vaccine, I grew exhausted and had to sleep into late evening and was chi... Read more
2 hours after receiving the vaccine, I grew exhausted and had to sleep into late evening and was chilled, had a fever of 101 and developed severe pain and inflammation on the top of my collar bone that was feverish and migrated toward my shoulder region on the same side as my vaccine. Ibuprofen would not help with the pain but helped with the fever. My mind told me that I had things to tend to the next day, but still was forced to sleep off and on for 2 more days. After a week and a half, not only did I have thirst, but also food didn't taste right and was metallic. This lasted for 2 days and finally my taste was restored. The exhaustion lasted off and on for 2 weeks and I just listened to my body. The pain and inflammation on my collar bone has subsided 4 days ago but still have pain in my shoulder when I sleep. On April 5 around 8:30 a.m. a nasty virus hit me out of the blue. I grew week and tired and had to go to bed. I slept all day until around 9:00 p.m. and woke to uncontrollable diarrhea and fainting spell while in the bathroom. I had abominable pain and nausea that last for a half hour and then I returned to bed. The next 2 days, I was week and exhausted but continued with my regular routine. My equilibrium is still affected from time to time.
62 2021-04-20 weakness Fever, body aches, headache, chills, tired, vomited bile, weak, high blood pressure, visual changes... Read more
Fever, body aches, headache, chills, tired, vomited bile, weak, high blood pressure, visual changes.
62 2021-04-20 pain in extremity, speech disorder SPEECH PROBLEM/SLUTTER; LACK OF MEMORY (FORGET THINGS); WEIGHT LOSS; HIGH BLOOD PRESSURE 172/95 SOME... Read more
SPEECH PROBLEM/SLUTTER; LACK OF MEMORY (FORGET THINGS); WEIGHT LOSS; HIGH BLOOD PRESSURE 172/95 SOMETIMES 180; RASH ON HER FACE; CHILLS; PAIN IN RIGHT ARM AND RIGHT LEG; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced speech problem/slutter, lack of memory (forget things), weight loss, high blood pressure 172/95 sometimes 180, rash on her face, chills, and pain in right arm and right leg. Laboratory data (dates unspecified) included: Blood pressure high (NR: not provided) BLOOD PRESSURE 172/95 SOMETIMES 180. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right arm and right leg, weight loss, chills, lack of memory (forget things), speech problem/slutter, rash on her face, and high blood pressure 172/95 sometimes 180. This report was non-serious.
62 2021-04-20 pain in extremity DIARRHEA; DIZZINESS; FUNNY TASTE; PAIN IN LEFT ARM; HEADACHES; NAUSEA; This spontaneous report recei... Read more
DIARRHEA; DIZZINESS; FUNNY TASTE; PAIN IN LEFT ARM; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic back pain, preexisting degenerative joint disease, non smoker, and non-alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced diarrhea. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced funny taste. On 09-APR-2021, the subject experienced pain in left arm. On 09-APR-2021, the subject experienced headaches. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 11-APR-2021, dizziness, and nausea on 10-APR-2021, and funny taste on 09-APR-2021, and had not recovered from pain in left arm, and headaches. This report was non-serious.
62 2021-04-20 pain in extremity Frontal lobe headache to start within a few hrs of vaccine. Back of the head to lower neck headache ... Read more
Frontal lobe headache to start within a few hrs of vaccine. Back of the head to lower neck headache 8 hrs after. Every tooth in my mouth started throbbing at around 11 hrs and continued for about 5 more hours. Also during that time, waves of nausea but no vomiting, also uncontrollable shivering but I wasn't cold and I wasn't hot but weird shivering. I did not take my temperature as I didn't feel like I had a fever. Around 13 hrs after a stabbing pain in front of thighs like hot pokers started and around 14 hrs thigh pain was still present but then the calves on both legs started to get the same stabbing pain. At around 24 hrs after - headache remained, pulsating teeth stopped, thigh pain stopped but calf pain remained. Headache remained off and on for several days. General brain fog also lasted for about 1 week. The calf pain comes and goes even after 2 weeks. Arm where shot was administered was very tender to the touch for the last 2 weeks. Lastly, I wouldn't say I had shortness of breath but at times I just felt like I needed to stop and force myself to take a very deep breath.
62 2021-04-21 weakness INCREASED HEART RATE; WEAKNESS; TIREDNESS AND EXHAUSTION; This spontaneous report received from a pa... Read more
INCREASED HEART RATE; WEAKNESS; TIREDNESS AND EXHAUSTION; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 04-APR-2021, the subject experienced increased heart rate. On 04-APR-2021, the subject experienced weakness. On 04-APR-2021, the subject experienced tiredness and exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from weakness, tiredness and exhaustion, and increased heart rate. This report was non-serious.
62 2021-04-21 hot flush HEADACHE; HOT FLASHES; This spontaneous report received from a patient concerned a 62 year old femal... Read more
HEADACHE; HOT FLASHES; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, and arthritis. The patient was previously treated with tramadol for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 13:40 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride/paracetamol for drug used for unknown indication. On 09-APR-2021, the subject experienced hot flashes. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flashes on 10-APR-2021, and headache on 12-APR-2021. This report was non-serious.
62 2021-04-21 muscle twitching, pain in extremity, muscle spasms MUSCLE SPASMS; STIFF NECK; TIGHTNESS IN THROAT; MUSCLE TWITCHES; HEAVINESS IN LIMBS; LOW GRADE FEVER... Read more
MUSCLE SPASMS; STIFF NECK; TIGHTNESS IN THROAT; MUSCLE TWITCHES; HEAVINESS IN LIMBS; LOW GRADE FEVER; ARM PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced arm pain. On 07-APR-2021, the subject experienced injection site pain. On 08-APR-2021, the subject experienced stiff neck. On 08-APR-2021, the subject experienced tightness in throat. On 08-APR-2021, the subject experienced muscle twitches. On 08-APR-2021, the subject experienced heaviness in limbs. On 08-APR-2021, the subject experienced low grade fever. On 12-APR-2021, the subject experienced muscle spasms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff neck, and heaviness in limbs on 10-APR-2021, had not recovered from low grade fever, injection site pain, muscle spasms, arm pain, and muscle twitches, and the outcome of tightness in throat was not reported. This report was non-serious.
62 2021-04-21 pain in extremity ECZEMA ON HAIRLINE AT THE BACK OF NECK AND BEHIND EARS, ON ELBOWS AND ON FRONT OF THE OF ANKLE/RASH/... Read more
ECZEMA ON HAIRLINE AT THE BACK OF NECK AND BEHIND EARS, ON ELBOWS AND ON FRONT OF THE OF ANKLE/RASH/ITCHINESS/BUMPS/REDNESS; SLIGHT SORE ARM; MILD HEADACHE; KIND OF PRESSURE BEHIND ONE EYE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 150 pounds, and height was 62 inches. The patient's concurrent conditions included non-smoker, non-alcohol user, and overweight, and other pre-existing medical conditions included the patient does not have any medical conditions and not taking any medication, the patient had no known allergies, the patient had no history of drug abuse or illicit drug use, the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced kind of pressure behind one eye. On 06-APR-2021, the subject experienced slight sore arm. On 06-APR-2021, the subject experienced mild headache. On 09-APR-2021, the subject experienced eczema on hairline at the back of neck and behind ears, on elbows and on front of the of ankle/rash/itchiness/bumps/redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight sore arm on 08-APR-2021, and mild headache on 06-APR-2021, had not recovered from eczema on hairline at the back of neck and behind ears, on elbows and on front of the of ankle/rash/itchiness/bumps/redness, and the outcome of kind of pressure behind one eye was not reported. This report was non-serious.
62 2021-04-21 pain in extremity I developed a nose bleed about an hour after injection. This lasted for about an hour. My arm was so... Read more
I developed a nose bleed about an hour after injection. This lasted for about an hour. My arm was sore for a few weeks, with a red "bullseye". This lasted for 2 weeks.
62 2021-04-21 pain in extremity RAISED RED MARK IN THE AREA OF SHOT; AREA OF SHOT HURT; HEADACHE; TIREDNESS; PAIN IN THE NECK; BITTE... Read more
RAISED RED MARK IN THE AREA OF SHOT; AREA OF SHOT HURT; HEADACHE; TIREDNESS; PAIN IN THE NECK; BITTER TASTE IN THE MOUTH; NASAL DRIPPING; DRIPPING BACK OF THROAT; SWELLING OF TONGUE; SORENESS OF BODY; DIFFICULTY IN BREATHING; PAIN IN RIGHT ARM; CHILLS; SHOULDER HURT; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip surgery, and knee replacement, and concurrent conditions included atrial fibrillation, hypertension, diabetes, gastrooesophageal reflux disease, rheumatoid arthritis, multiple myleloma, egg allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not had any drug abuse or illicit drug use. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 10:00 for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, metformin for diabetic, torasemide for diuretic, omeprazole for gastrooesophageal reflux disease, pantoprazole for gastrooesophageal reflux disease, amlodipine for hypertension, eplerenone for hypertension, sodium perborate monohydrate for hypokalemia, paracetamol for rheumatoid arthritis, atorvastatin, and ubidecarenone. On 08-APR-2021, the subject experienced pain in the neck. On 08-APR-2021, the subject experienced bitter taste in the mouth. On 08-APR-2021, the subject experienced nasal dripping. On 08-APR-2021, the subject experienced dripping back of throat. On 08-APR-2021, the subject experienced swelling of tongue. On 08-APR-2021, the subject experienced soreness of body. On 08-APR-2021, the subject experienced difficulty in breathing. On 08-APR-2021, the subject experienced pain in right arm. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced shoulder hurt. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tiredness. On 12-APR-2021, the subject experienced raised red mark in the area of shot. On 12-APR-2021, the subject experienced area of shot hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bitter taste in the mouth, nasal dripping, dripping back of throat, swelling of tongue, and difficulty in breathing on 08-APR-2021, and chills on 12-APR-2021, was recovering from raised red mark in the area of shot, and area of shot hurt, and had not recovered from headache, pain in the neck, pain in right arm, tiredness, shoulder hurt, and soreness of body. This report was non-serious.
62 2021-04-21 tingling, pain in extremity TINGLING OF FINGER TIPS OF LEFT HAND; HEADACHE; TIRED; ARM PAIN; This spontaneous report received fr... Read more
TINGLING OF FINGER TIPS OF LEFT HAND; HEADACHE; TIRED; ARM PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cat allergy, alcohol user, and smoker, and other pre-existing medical conditions included the patient had no any drug abuse or illicit drug usage and other pre-existing medical conditions included nothing significant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included minerals nos/vitamins nos. On 07-APR-2021, the subject experienced arm pain. Treatment medications included: Tylenol (paracetamol). On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced tingling of finger tips of left hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling of finger tips of left hand on 09-APR-2021, arm pain on 08-APR-2021, headache on 10-APR-2021, and tired on 11-APR-2021. This report was non-serious.
62 2021-04-21 tremor DIZZINESS; HEADACHE; FEVER; TIREDNESS; SHAKING; GENERALISED ACHING; CHILLS; This spontaneous report ... Read more
DIZZINESS; HEADACHE; FEVER; TIREDNESS; SHAKING; GENERALISED ACHING; CHILLS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 17:20 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced generalised aching. On 11-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced shaking. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced tiredness. On 13-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-APR-2021, and was recovering from generalised aching, chills, fever, shaking, tiredness, and dizziness. This report was non-serious.
62 2021-04-22 feeling cold HAND EXTREMELY COLD; SEVERE CHILLS/TEETH CHATTERED; FREEZING; This spontaneous report received from ... Read more
HAND EXTREMELY COLD; SEVERE CHILLS/TEETH CHATTERED; FREEZING; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included leukopenia, hypothyroid, and epstein barr, and concurrent conditions included unspecified allergies, chronic medical condition, non alcohol, non smoker, arthirits, high cholesterol, gastroesophageal reflux disease, fibromyalgia, food allergy, animal allergy, nickel allergy, and degenerative disc disease, and other pre-existing medical conditions included the patient is on thyroid medication, no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 15:30 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for blood thinner, calcium for general health, fish oil for general health, vitamins nos for general health, levothyroxine sodium for hypothyroid, and fluticasone for unspecified allergies. On 21-MAR-2021, the subject experienced hand extremely cold. On 21-MAR-2021, the subject experienced severe chills/teeth chattered. On 21-MAR-2021, the subject experienced freezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand extremely cold, severe chills/teeth chattered, and freezing on 22-MAR-2021 04:00. This report was non-serious. This case, from the same reporter is linked to 20210342283. Additional information was received from (patient) on 13-apr-2021 .The following information was updated and incorporated into the case narrative; Events details ,disease, concomitant product
62 2021-04-22 flushing FLUSHED; WATERING EYES; SUNBURN-LIKE RASH; CHILLS; LOW GRADE FEVER; This spontaneous report received... Read more
FLUSHED; WATERING EYES; SUNBURN-LIKE RASH; CHILLS; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd from 911 exposure, asthma, chronic rhinitis, thyroiditis, lipidaemia, codeine allergy, and levaquin allergy. The patient experienced drug allergy when treated with betamethasone, ciprofloxacin, and bupivacaine hydrochloride/epinephrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced flushed. On 10-APR-2021, the subject experienced watering eyes. On 10-APR-2021, the subject experienced sunburn-like rash. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced low grade fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed, and sunburn-like rash on 11-APR-2021, and watering eyes, chills, and low grade fever on 12-APR-2021. This report was non-serious.
62 2021-04-22 feeling of insects crawling on skin SLIGHT HEADACHE; SORE ARM AT SITE OF INJECTION; CRAWLING SENSATION; COLD; This spontaneous report re... Read more
SLIGHT HEADACHE; SORE ARM AT SITE OF INJECTION; CRAWLING SENSATION; COLD; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: 19/MAY/2021) dose was not reported, administered on 06-MAR-2021 13:15 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced crawling sensation. On 06-MAR-2021, the subject experienced cold. On 06-MAR-2021, the subject experienced sore arm at site of injection. On 07-MAR-2021, the subject experienced slight headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crawling sensation, and cold on 07-MAR-2021, slight headache on 08-MAR-2021, and sore arm at site of injection on MAR-2021. This report was non-serious.
62 2021-04-22 hot flush HOT FLASH; NAUSEA; JOINT PAIN/JOINT BURNING; FOGGINESS; VOMITING; FACIAL REDNESS; METALLIC TASTE; AP... Read more
HOT FLASH; NAUSEA; JOINT PAIN/JOINT BURNING; FOGGINESS; VOMITING; FACIAL REDNESS; METALLIC TASTE; APPETITE LOST; SWOLLEN TONGUE; PAIN TONGUE; PEELING TONGUE; ADVERSE REACTION; LOSS OF TASTE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 04DDZ1D expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced hot flash. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced joint pain/joint burning. On APR-2021, the subject experienced fogginess. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced facial redness. On APR-2021, the subject experienced metallic taste. On APR-2021, the subject experienced appetite lost. On APR-2021, the subject experienced swollen tongue. On APR-2021, the subject experienced pain tongue. On APR-2021, the subject experienced peeling tongue. On APR-2021, the subject experienced adverse reaction. On APR-2021, the subject experienced loss of taste. The dose of covid-19 vaccine ad26.cov2.s was increased. The outcome of the hot flash, nausea, joint pain/joint burning, fogginess, vomiting, facial redness, metallic taste, appetite lost, swollen tongue, pain tongue, peeling tongue, adverse reaction and loss of taste was not reported. This report was non-serious.
62 2021-04-22 tingling, numbness PT CALLED C/O NUMBNESS/TINGLING LEFT ARM FROM FINGERS TO SHOULDER 2 DAYS AFTER SHOT; HAD DIZZINESS F... Read more
PT CALLED C/O NUMBNESS/TINGLING LEFT ARM FROM FINGERS TO SHOULDER 2 DAYS AFTER SHOT; HAD DIZZINESS FOR ABOUT 3 DAYS; FATIGUE; HAS HX OF HEART FLUTTERS BUT GREATLY INCREASED AND CONTINUES NOW; KNOT IN ARM JUST RESOLVED YESTERDAY
62 2021-04-24 weakness My wife has been sick for a few days with a slight fever, chills, weakness and cough. We figured sh... Read more
My wife has been sick for a few days with a slight fever, chills, weakness and cough. We figured she may have caught the Flu. Today she woke up and had no balance with the other symptoms listed. They went over her symptoms with her and gave her a rapid COVID test , according to their test she was found to be POSITIVE for COVID-19. Just can't understand this as she received her vaccination on the 7th.
62 2021-04-25 pain in extremity 1 week post vaccine had 1 day with a sore throat and runny nose. Developed right calf pain 04/19/202... Read more
1 week post vaccine had 1 day with a sore throat and runny nose. Developed right calf pain 04/19/2021. Presented to ER on 04/25/2021 w/ a 2 day history of shortness of breath and some chest tightness worse with exertion, with worsening symptoms at time of ER visit. Admitted for observation with "Pulmonary embolism without acute cor pulmonale and Acute respiratory failure with hypoxia"
62 2021-04-26 migraine Day vaccine was administered to patient the only effective on that date was Tired and drowsiness w... Read more
Day vaccine was administered to patient the only effective on that date was Tired and drowsiness were experienced. in the late afternoon this condition was only intensified . The next business day was difficult due to a Migraine that was in full force on that Friday. Patient was unable to perform any actions including Work from home. Patient slept for the next 20 hours. Other than sleep no other actions were committed. On that date 3/19/2021 it was noticed that her eyes were sensitive to Light and were also very puffy.. On the Sunday there was little and or no change still sensitive to light and the puffiness was still felt but the eyes were so swollen that it was almost impossible to open them. The Urgent care patient went to on the Sunday was the initial with Healthcare facility
62 2021-04-26 nerve injury J&J vaccine given on 3/14. Pt states vaccine placement was too high and not given in the muscle. Pt ... Read more
J&J vaccine given on 3/14. Pt states vaccine placement was too high and not given in the muscle. Pt states has permanent nerve damage as a result
62 2021-04-26 pain in extremity VOMITING; FEET AND LEG PAIN; This spontaneous report received from a patient concerned a 62 year old... Read more
VOMITING; FEET AND LEG PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included aspirin allergy, and concurrent conditions included history of blood clot, and chronic inflammatory demyelinating polyneuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included immunoglobulin human normal for chronic inflammatory demyelinating polyneuropathy. On 28-MAR-2021, the subject experienced vomiting. On 28-MAR-2021, the subject experienced feet and leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting and feet and leg pain was not reported. This report was non-serious.
62 2021-04-26 pain in extremity FEVER; HEADACHE; NAUSEA; LIVER PAIN; TIPSY; LIGHT HEADEDNESS; COLD CHILLS; LEFT LEG PAIN; This spont... Read more
FEVER; HEADACHE; NAUSEA; LIVER PAIN; TIPSY; LIGHT HEADEDNESS; COLD CHILLS; LEFT LEG PAIN; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included hepatitis c, and concurrent conditions included controlled epileptic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included silybum marianum for hepatitis c, bifidobacterium bifidum/bifidobacterium lactis/fructooligosaccharides/lactobacillus acidophilus/lactobacillus casei for immune system, and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for nutritional supplement. On APR-2021, the subject experienced cold chills. On APR-2021, the subject experienced left leg pain. Laboratory data included: Pain scale (NR: not provided) pain score 2 or 3. On 09-APR-2021, the subject experienced liver pain. On 09-APR-2021, the subject experienced tipsy. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the liver pain, left leg pain, light headedness, tipsy, headache, nausea, fever and cold chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious
62 2021-04-26 tenderness developed shingles, right side above shoulder blade under right arm over breast and down.
62 2021-04-26 tremor, cold sweat SWEATING; INCREASED BLOOD PRESSURE; EXTREME THIRST; SHAKINESS; CONFUSION; MILD HEADACHE; DRY MOUTH; ... Read more
SWEATING; INCREASED BLOOD PRESSURE; EXTREME THIRST; SHAKINESS; CONFUSION; MILD HEADACHE; DRY MOUTH; CLAMMINESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 100 pounds, and height was not reported. The patient's pre-existing medical conditions included normally had low blood pressure was at 170/92. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced dry mouth. On APR-2021, the subject experienced clamminess. Laboratory data included: Blood pressure (NR: not provided) stabilized. On 18-APR-2021, the subject experienced extreme thirst. On 18-APR-2021, the subject experienced shakiness. On 18-APR-2021, the subject experienced confusion. On 18-APR-2021, the subject experienced mild headache. On 19-APR-2021, the subject experienced sweating. On 19-APR-2021, the subject experienced increased blood pressure. Laboratory data included: Blood pressure (NR: not provided) 170/92 mmHg. Treatment medications (dates unspecified) included: atenolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased blood pressure, and the outcome of extreme thirst, shakiness, confusion, mild headache, sweating, dry mouth and clamminess was not reported. This report was non-serious.
62 2021-04-28 migraine, numbness, pain in extremity The day after my J&J vaccine, I experienced left leg and knee pain with numbness sensation. I had a... Read more
The day after my J&J vaccine, I experienced left leg and knee pain with numbness sensation. I had a left knee replacement in September 2020. I experience numbness below and above my knee cap. I also experienced bad migraines , arm soreness at the injection site. I called my doctor and he gave me an appointment to see him and he did not think it was related to the vaccine but he was not sure since I do have history of rheumatoid arthritis. Today my left knee and leg still feel numb and I am taking my regular medications as instructed.
62 2021-04-28 pain in extremity Patient was seen in my office by me on April 27th. She reports having left leg pain discomfort which... Read more
Patient was seen in my office by me on April 27th. She reports having left leg pain discomfort which started 3 days after receive Johnson and Johnson COVID vaccine. She denies swelling or any other associated symptoms. I ordered Venous Duplex which was done today and revealed b/l femoral DVT. Patient immediately started on Eliquis .
62 2021-04-30 burning sensation BURNING SENSATION IN THE GROIN AREA; This spontaneous report received from a patient concerned a 62 ... Read more
BURNING SENSATION IN THE GROIN AREA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included groin discomfort, and covid 19 infection. The patient was previously treated with steroids for drug used for unknown indication, diphenhydramine hydrochloride for drug used for unknown indication, and antibiotics for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 12-APR-2021, the subject experienced burning sensation in the groin area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation in the groin area. This report was non-serious.
62 2021-04-30 migraine BOTTOM EYELIDS ROLLING INWARDS TOWARDS EYES; LIGHT SENSITIVITY TO EYE; EYE RED; ENTROPION IN EYE; PA... Read more
BOTTOM EYELIDS ROLLING INWARDS TOWARDS EYES; LIGHT SENSITIVITY TO EYE; EYE RED; ENTROPION IN EYE; PAIN EYE; MIGRAINE HEADACHE; FOGGY FEELING IN HEAD; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 140 pounds, and height was 67 inches. The patient's concurrent conditions included codeine allergy, alcohol consumption, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amoxicillin for allergic reaction, and for allergic reaction. On 18-MAR-2021, the subject experienced foggy feeling in head. On 19-MAR-2021, the subject experienced migraine headache. On 20-MAR-2021, the subject experienced pain eye. On 20-MAR-2021, the subject experienced light sensitivity to eye. On 20-MAR-2021, the subject experienced eye red. On 20-MAR-2021, the subject experienced entropion in eye. On 21-MAR-2021, the subject experienced bottom eyelids rolling inwards towards eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy feeling in head on 18-MAR-2021, had not recovered from pain eye, light sensitivity to eye, entropion in eye, and bottom eyelids rolling inwards towards eyes, and the outcome of migraine headache and eye red was not reported. This report was non-serious.
62 2021-05-02 pain in extremity After injection I too seat to wait 15-20 minutes. Immediately I started to lose peripheral vision an... Read more
After injection I too seat to wait 15-20 minutes. Immediately I started to lose peripheral vision and then my hearing....I called for help. They took me in a room to lay down and said my blood pressure had dropped vary low. After an out of doing better I just needed t get home. So another hour passes and I get home, go directly to bed and what seems like a bad flu begins. That night my temperature continues to climb, the aches and headache are horrible. I continue fevers for 3 nights. Feel a little better and then with 2 days it relapse and all starts again. I am in bed for 1 and 1/2 weeks, then stay home due to continued headache, dizziness. After 3 weeks the dizziness continues and I then start getting an aching pain in the back of my left leg. Seeing my doctor on May 11th and hope to discuss.
62 2021-05-04 facial pain, weakness, involuntary muscle movements, muscle spasms, tremor Janssen COVID-19 Vaccine EUA Extreme chills and quaking, despite 3 blankets and two heating pads, o... Read more
Janssen COVID-19 Vaccine EUA Extreme chills and quaking, despite 3 blankets and two heating pads, occasional jerks of my body -within 7 hours. Lasted 20 hours or more. Fatigue- unable to walk myself to bathroom within 8 hours, lasted two or more days. Very weak. VERY Severe Headache, including facial pain, neck pain, temple pain and eye sockets , stared 7 hrs, lasted two days Severe nausea, I actually thought of food poisoning (but it wasn't). Approx. onset 9 hours. Very painful body aches and muscle spasms throughout my body but especially my Back, underarms, legs, feet. Approx. onset 7 hours. lasted 48 to 60 hour Diabetic Ketoacidosis approx 30 hours after. Wasn't able to eat, blood sugar remained in the 150 to 180 area. Managed to eat 2 TBsp of applesauce to reduce ketones, (which worked) Fatigue unable to work until 5 days later.
62 2021-05-06 bell's palsy Bell Palsey
62 2021-05-07 weakness DIZZINESS; FEEL LIKE LEGS WERE GOING TO COLLAPSE; This spontaneous report received from a consumer c... Read more
DIZZINESS; FEEL LIKE LEGS WERE GOING TO COLLAPSE; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUNE-2021) dose was not reported, administered on 04-MAY-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced dizziness. On 05-MAY-2021, the subject experienced feel like legs were going to collapse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel like legs were going to collapse, and dizziness. This report was non-serious.
62 2021-05-08 nerve pain, bell's palsy Patient developed left 7th nerve pain and subsequent left sided Bell's Palsy approximately 3 weeks a... Read more
Patient developed left 7th nerve pain and subsequent left sided Bell's Palsy approximately 3 weeks after vaccine administration
62 2021-05-11 feeling cold VERY LOW TEMPERATURE; VERY LIGHT-HEADED; LIPS WERE COLD; MUSCLE SORENESS; CHILLS; HEADACHE; BODY ACH... Read more
VERY LOW TEMPERATURE; VERY LIGHT-HEADED; LIPS WERE COLD; MUSCLE SORENESS; CHILLS; HEADACHE; BODY ACHES /LITTLE SORE; FEELING WORSE; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 170 pounds, and height was not reported. The patient's concurrent conditions included depression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 13:00 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride for depression. On MAY-2021, the subject experienced body aches /little sore. On MAY-2021, the subject experienced feeling worse. On 06-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced muscle soreness. On 08-MAY-2021, the subject experienced very low temperature. On 08-MAY-2021, the subject experienced very light-headed. On 08-MAY-2021, the subject experienced lips were cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 94 F. Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, muscle soreness, body aches /little sore, lips were cold, very low temperature, very light-headed and feeling worse was not reported. This report was non-serious.
62 2021-05-11 pain in extremity Intense pain in left arm 3 days after COVID J&J vaccine. Pain is not at injection site, but below an... Read more
Intense pain in left arm 3 days after COVID J&J vaccine. Pain is not at injection site, but below and stops at elbow.
62 2021-05-12 numbness Extreme muscle aches and joint pain throughout the entire body which started in the evening. I did n... Read more
Extreme muscle aches and joint pain throughout the entire body which started in the evening. I did not sleep well with the pain with not being able to lay on my sides as my arms would go numb and I hurt terribly the next day until the afternoon when I took two Advils.
62 2021-05-13 weakness I have MS and I was having some stomach issues and they said it wouldn't be a problem but I ended up... Read more
I have MS and I was having some stomach issues and they said it wouldn't be a problem but I ended up in the hospital for 5 days then in rehab. I woke up about 2am after vaccine and when trying to go to bathroom my legs gave out and I hit the floor, we called EMS to get me up and I was really weak. My legs were gone the rest of the night and I couldn't stand my husband had to help me . On the 24th, we called the EMS to take me to the hospital and they sent me to rehab and I got out of there on the 28th to home but I do not have my strength back.
62 2021-05-15 numbness pts hands are numb
62 2021-05-18 muscle spasms LEG CRAMPS; TIREDNESS; This spontaneous report received from a patient concerned a 62 year old femal... Read more
LEG CRAMPS; TIREDNESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 140 pounds, and height was 153 centimeters. The patient's past medical history included left ankle injury, and leg cramps, and concurrent conditions included seasonal allergy, social alcohol drinker, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. history of taking birth control medication 40 years ago but she stopped it since then due to severe leg cramps. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included naproxen sodium. On 15-MAY-2021, the subject experienced leg cramps. On 15-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine a was not applicable. The patient recovered from leg cramps on 15-MAY-2021, and had not recovered from tiredness. This report was non-serious.
62 2021-05-19 coordination abnormal, numbness, tingling TINGLING HANDS AND FEET; NUMBNESS HANDS AND FEET; PAIN WITH MOVEMENT; DROPPING THINGS; This spontane... Read more
TINGLING HANDS AND FEET; NUMBNESS HANDS AND FEET; PAIN WITH MOVEMENT; DROPPING THINGS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dropping things. On 28-APR-2021, the subject experienced tingling hands and feet. On 28-APR-2021, the subject experienced numbness hands and feet. On 28-APR-2021, the subject experienced pain with movement. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from tingling hands and feet, numbness hands and feet, and pain with movement, and the outcome of dropping things was not reported. This report was non-serious.
62 2021-05-19 pain in extremity Old injuries are flaring up again. In 2010, I dropped a 45-pound Olympic weightlifting bar from over... Read more
Old injuries are flaring up again. In 2010, I dropped a 45-pound Olympic weightlifting bar from overhead onto my foot and fractured 3 bones. That was treated and healed (cast and flexible cam walker). In 2013 I had surgery on my left wrist for Derkervains. That healed up just fine also. All of the sudden, both past injuries have flared up again. I had foot pain so bad that I couldn't walk for a day. An Xray shows no damage. Yesterday, my wrist has flared up and is very painful. I have not seen a doctor about that. My foot is improving. I think it will bounce back. I now suspect that my wrist will also improve. My hypothesis is that the vaccine has challenged my immune system enough that old injuries are flaring up and then calming back down again. It's very odd. I don't know if it's significant, but thought I should report it, in case my experience matters.
62 2021-05-19 pain in extremity Sun I woke in middle of night with pain in thumb. There was nothing there. When I got up few hours l... Read more
Sun I woke in middle of night with pain in thumb. There was nothing there. When I got up few hours later my thumb on left hand had enormous blood blister. Which immediately grew, was infected, and whole hand swelled up. Wednesday night I had same pain under right eye. Again nothing was there. Few hours later my eye was all swollen. I have another Dr appt tomorrow with Dr. I had the emergency room take care of my thumb. That Dr, Dr , a few days later sent me to Dr.
62 2021-05-19 pain in extremity SORE ARM; This spontaneous report received from a patient concerned a 62 year old female. The patien... Read more
SORE ARM; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced sore arm. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm on 05-MAY-2021. This report was non-serious.
62 2021-05-25 weakness see above
62 2021-05-25 weakness Started with weakness, then shortness of breath, multiple syncopal episodes. Bilateral popliteal DVT... Read more
Started with weakness, then shortness of breath, multiple syncopal episodes. Bilateral popliteal DVT, multiple bilateral PE's with no other risk factors. Symptoms started approximately 2 weeks ago. Hospital admission date was 5/26/2021. Obstructive shock from PE, required ICU care, vasopressor therapy, and EKOS therapy, IVC filter. Improved from shock after EKOS therapy, no longer need vasopressors. Heparin infusion post EKOS therapy. Will be going home on oral anticoagulation when appropriate for discharge. Shock liver as a complication from the obstructive shock.
62 2021-05-25 flushing On 4/27 at 6:30 p.m., I became flushed and my skin felt hot. Next, I began itching EVERYWHERE, my ar... Read more
On 4/27 at 6:30 p.m., I became flushed and my skin felt hot. Next, I began itching EVERYWHERE, my arms especially. I scratched so hard I bruised my arms! My skin turned bright red. I chewed 2 Benadryl, and after about an hour it faded somewhat but I kept itching until about midnight. My family monitored me to make sure I didn't go into anaphylactic shock. The nest day I called my physician's assistant and he said just to monitor it, in case it happened again. It happened again on 5/4/21 at 10:30 p.m. It was not as severe, but I took 2 Benadryl immediately, since I recognized what was happening. I was better by about 12:30 a.m.. I had been in contact with my PA regarding my statins, and he said there wasn't anything they could do but to report it. He didn't think it was the statin that I had been taking, as I had discontinued the statin after the first incident, due to other concerns.
62 2021-05-25 hot flush hives across chest, both arms and upper back-hot flashes (not related to menopause)
62 2021-05-25 pain in extremity Fatigue, Sore throat, headache, arm pain, dizziness, jaw pain.
62 2021-05-25 pain in extremity The soreness experienced continued for a week to the day of the shot and on the 8th day until the p... Read more
The soreness experienced continued for a week to the day of the shot and on the 8th day until the present became increasingly unbearable. I'm unable to dress myself because the pain in my left arm is excruciating. I can't raise my arm for more than a foot from my side. I've taken ibuprofen and am using ice compresses, but it doesn't help enough. So far I've missed 3 days of work. I cannot dress myself, so I know I can't drive. Please advise. I also massage the sore area to keep my arm from stiffening up.
62 2021-05-25 tremor Approximately 5.5 hrs after vaccination - High fever with severe full body shakes lasting about 3 ho... Read more
Approximately 5.5 hrs after vaccination - High fever with severe full body shakes lasting about 3 hours followed by a slight fever of 99.7 for about 16 hours, severe headache lasting about 24 hours, Full body aches lasting about 16 hours, tiredness lasting about 36 hours, moderate headache lasting about 3 days.
62 2021-05-26 pain in extremity Right Bicep pain, swelling started about 3 weeks post vaccine. Diagnosed with Bracial DVT 5/26/21
62 2021-05-29 pain in extremity Next day I had chills, but day 2, my arms and wrists hurt badly.
62 2021-05-31 difficulty speaking fever, dizzy, headache, severe pain throughout body for 24 hours, screaming pain could feel vaccine ... Read more
fever, dizzy, headache, severe pain throughout body for 24 hours, screaming pain could feel vaccine going through entire body tiredness hoarseness, heavy breathing 6 weeks after vaccine
62 2021-06-03 seizure J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified R56.9 - Unspecifie... Read more
J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified R56.9 - Unspecified convulsions
62 2021-06-10 pain in extremity JOINT PAIN; SORE ARM; MUSCLE ACHES; HEADACHES; INJECTION SITE PAIN; This spontaneous report received... Read more
JOINT PAIN; SORE ARM; MUSCLE ACHES; HEADACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hit by a drunk driver when was 20, and concurrent conditions included osteoarthritis, and body aches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced joint pain. On 03-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced muscle aches. On 03-JUN-2021, the subject experienced headaches. On 03-JUN-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, headaches, joint pain, and sore arm, and the outcome of injection site pain was not reported. This report was non-serious.
62 2021-06-13 weakness, migraine MIGRAINE ON RIGHT FRONT SIDE; FEELING SLEEPY; LACK OF ENERGY; HEADACHE ON RIGHT FRONT SIDE; FATIGUE... Read more
MIGRAINE ON RIGHT FRONT SIDE; FEELING SLEEPY; LACK OF ENERGY; HEADACHE ON RIGHT FRONT SIDE; FATIGUE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included tested positive for covid-19. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced migraine on right front side. On 10-JUN-2021, the subject experienced feeling sleepy. On 10-JUN-2021, the subject experienced lack of energy. On 10-JUN-2021, the subject experienced headache on right front side. On 10-JUN-2021, the subject experienced fatigue. Laboratory data included: Pain scale (NR: not provided) 7. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on right front side, feeling sleepy, lack of energy, headache on right front side, and fatigue on 11-JUN-2021. This report was non-serious.
62 2021-06-17 flushing, tingling Allergic type reaction Itching on face, scalp, arms, legs, torso Started approx. 50 hours after inje... Read more
Allergic type reaction Itching on face, scalp, arms, legs, torso Started approx. 50 hours after injection Treated with OTC Benadryl, 2 doses thus far Patient continued with milder itching and a tingling sensation, similar to a Niacin "flush" on the skin Continued condition remains after 72 hours after injection
62 2021-06-18 migraine, weakness Patient received J and J covid vaccine on 3/7/21. She did not feel well for the next few days and ha... Read more
Patient received J and J covid vaccine on 3/7/21. She did not feel well for the next few days and had the following symptoms: headache, fatigue, nausea, body aches, loss of taste. She recovered after a few days and was doing well until 6/11/21. She began having the following symptoms: migraine headache, nausea, dizziness, loss of appetite, blurred vision, weakness, loss of taste, muscle weakness and joint pain. She went to ER on 6/13/21. They did a cat scan and ekg, both came back normal. They did not do a covid test. She then went to her regular Dr. on 6/15/21 and he gave her topiramate. He did not do a covid test. She was off work for a week and returned to work on 6/18/21. She is feeling better now and has worked for the last two days. She came to pharmacy and told me what was happening and she thinks that her symptoms are from the original J and J covid vaccine on 3/7/21 and she is worried that she may have recurring symptoms for the vaccine
62 2021-06-20 pain in extremity SHOULDER AND ARM HAVE BEEN PAINFUL SINCE, REDUCED RANGE IN MOTION
62 2021-06-20 tingling Headache, generalized body aches, mouth and face paresthesia
62 2021-06-21 discomfort For the first two-three weeks I had a feeling that something was not right with my veins on the back... Read more
For the first two-three weeks I had a feeling that something was not right with my veins on the back of my knees e.g. could not sit for more than a few minutes and had to "walk it off". Once those symptoms were gone I was left with a discomfort or pain in my veins especially when my arms, wrists and my knees are bent and there is no normal flow. The pain is similar to as if you accidentally crashed your vein or if you were a few days hooked up to an IV from the same spot. If feels like a low grade vein inflammation that just does not go away. My veins are in general sensitive to pressure now. I nevere had such symptoms until I took Janssen. I saw the vascular specialist and they ruled out blood cloths or varicose veins problems. Over all blood tests look OK. Yet I am left with this pain and no one knows what this is about. Is this some kind of auto-immune response?.
62 2021-06-29 pain in extremity severe right arm pain over bicep and tricep, limits ROM, sharp shooting pain down arm, wakes her fro... Read more
severe right arm pain over bicep and tricep, limits ROM, sharp shooting pain down arm, wakes her from sleep, no localized reaction, pulses and circulation are normal, pain does not improving with tylenol or ibuprofen.
62 2021-07-03 pain in extremity, muscle spasms, weakness spasms in the inner elbow down to the hand. Both hands are extremely sore and loss of strength.
62 2021-07-04 muscle spasms, facial pain, burning sensation, numbness and pain in extremities, muscle twitching, weakness, pain in extremity Pain and burning on L side (arm, shoulder, neck, face, ear, back), headaches, brain fog, anxiety, tw... Read more
Pain and burning on L side (arm, shoulder, neck, face, ear, back), headaches, brain fog, anxiety, twitching, spasms, neuropathy in feet, low appetite, fatigue, weakness, tired eyes, blurry vision, heart palpitation when lying on either side at night, hypo thyroid
62 2021-07-06 difficulty speaking Wheezing; cough; similar symptoms to a cold but more attributed to asthma. Prednisone to treat - two... Read more
Wheezing; cough; similar symptoms to a cold but more attributed to asthma. Prednisone to treat - two week course - I had saw two different doctors and they gave me two different dosages. The first one was two pills a day for five days. The second was six pills for seven days and then tapered off. Codeine with cough syrup and Singulair, as well, to treat. It's been two weeks and I'm just now hearing my voice kind of get back to my normal tone. Still having symptoms but milder.
62 2021-07-07 tremor Patient reported feeling shakiness and lightheaded after initial vaccine, following 20 minute observ... Read more
Patient reported feeling shakiness and lightheaded after initial vaccine, following 20 minute observation period patient reported feeling more normal, and left. Patient reported this is the first vaccine she has had since childhood.
62 2021-07-08 pain in extremity Right after you received the vaccine on 03/31/2021, it was painful, but I thought it was just a shot... Read more
Right after you received the vaccine on 03/31/2021, it was painful, but I thought it was just a shot pain, put I thought it was extremely painful. On my drive home it kept hurting. Finally on 04/17/2021, I was concerned because that was the time the media was mentioning blood clots from the vaccine. Because my arm, my shoulder hurt, and under my arm still continued to hurt I went into the ER. The doctor did not feel any abnormality in my arm. Till this day I still feel soreness in your arm and shoulder and under my arm. I can't extend my arm or use my arm. I use it cautiously, if I use it. I have had 3 or 4 visits with my doctor and she put me on methylpred 4 mg/ triage pack. It helped somewhat with the pain, but I still had soreness. So she prescribed Methocarban 500 mg. I just took it for 3 days. and it upset my stomach and gave me diarrhea . Now I have an MRI that is scheduled, but I don't know when at this point. I have to see if my insurance will cover it. I'm still pursuing to see why my soreness is persisting.
62 2021-07-10 hot flush, migraine I am 7 years post-menopausal, and 6 weeks after the vaccine I had a week-long, full-fledged menstrua... Read more
I am 7 years post-menopausal, and 6 weeks after the vaccine I had a week-long, full-fledged menstrual period. Then for the next five or six weeks, I had 4 or 5 hot flashes every day (I never had any in my 7 years of being post-menopausal). I also had a migraine mid morning every day after the menstrual period. They have lessened now (tapered and mostly stopped by end of June 2021). I also have slight balance problems now, that are still ongoing.
62 2021-07-16 pain in extremity SORE ARM; This spontaneous report received from a patient concerned a 62 year old female. The patien... Read more
SORE ARM; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1205A21A expiry: UNKNOWN) dose was not reported, administered on 12-JUL-2021 10:45 for prophylactic vaccination. No concomitant medications were reported. On 12-JUL-2021, the subject experienced sore arm. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm. This report was non-serious. This case, from the same reporter is linked to 20210728046 and 20210733974.
62 2021-07-18 mild one side paralysis, numbness, tingling headache, left side of face was numb, tingling, weak right leg. this was all within a few days of r... Read more
headache, left side of face was numb, tingling, weak right leg. this was all within a few days of receiving vaccine. I am now 3 months in, and continue with facial numbness on both sides of face, and weakness in right leg. These symptoms come and go, but I have them frequently. I might be a few days between the symptoms, but they always come back.
62 2021-07-20 bell's palsy Became diagnosed with Bells palsy, affected on Left side.
63 2021-03-06 tremor, pain in extremity I noticed aching in my legs and 3 hours later I woke up and it was worse. I also had chills and shak... Read more
I noticed aching in my legs and 3 hours later I woke up and it was worse. I also had chills and shaking, a slight headache, and mild nausea. This continued into the next day (March 7, 2021). It was significantly better by mid-afternoon.
63 2021-03-07 pain in extremity, weakness, breast pain Half hour after injection my throat felt tight and my OPPOSITE arm hurt. About 1:00 am I got so chi... Read more
Half hour after injection my throat felt tight and my OPPOSITE arm hurt. About 1:00 am I got so chilled I couldn't get warm, I did not take my temperature because my thermometer goes under my tongue and I was afraid I would break it cause my teeth were chattering so bad. The next day I felt very weak and nauseous. Then I discovered I had a rash at the top of my legs. My left breast was very sore I felt like someone punched me. Today is Monday and I still have diarrhea.
63 2021-03-10 feeling hot Patient state she felt light headed and dizziness and "weird". Patient was sitting at the time and I... Read more
Patient state she felt light headed and dizziness and "weird". Patient was sitting at the time and I had the patient lay on the ground to prevent any injury in the event she were to pass out. Due to her stating she felt so hot and "bad" 911 was called and dispatched. Upon arrival the patient was seated. and stated she felt weird to the EMS. She stated she did not want to go to the hospital but was unsure if she could stand without passing out. Vaccine was given around 11:40 am and around 11:50 to 11:54am patient started complaining of not feeling well. EMS arrived within 10 minutes of calling 911. Patient stated she did not want to go to the hospital but would go to the ambulance to be evaluated. EMS stated they could exam her in the ambulance and decide from there if she wanted to go to the hospital.
63 2021-03-10 pain in extremity, tremor Eight hours after the vaccine, I awoke with moderate chills and tremors. Eleven hours after the vac... Read more
Eight hours after the vaccine, I awoke with moderate chills and tremors. Eleven hours after the vaccine, i awoke with all-over body aches and a mild headache. I slept 3 more hours and woke up with all of the previous symptoms at once. I felt moderate malaise and these symptoms for 24 hours. I had a sore arm for 4 days.
63 2021-03-11 tingling Patient is a 63 y.o. female who received the Janssen COVID Lot#: 1805020 on 3/12/2021. The patient e... Read more
Patient is a 63 y.o. female who received the Janssen COVID Lot#: 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate 15 of observation: "tingling around lips and left arm" Patient was treated/managed as follows: 1120: BP: 162/80 HR:65 RR: 18 O2: 99% 1130: BP: 160/90 HR: 69 RR:18 O2: 98% Pt reports tingling has completely stopped and feels fine. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to door by RN.
63 2021-03-11 tremor 6:20pm Chills with uncontrollable shaking, headache, muscle aches. Took 2 ibuprophen. Went to bed. H... Read more
6:20pm Chills with uncontrollable shaking, headache, muscle aches. Took 2 ibuprophen. Went to bed. Headache continued. 9:30pm Started having chills again along with headache and muscle aches. Took 2 Tylenol. Fell asleep. Woke around 11:30pm with a pulse of 112bpm (which normally would have been 58bpm) and a headache. Fell asleep. Woke around 6am with a headache. Got up around 11am. Still feel tired.
63 2021-03-13 night sweats, tremor Janssen COVID-19 Vaccine EUA Based on the paperwork I received at my vaccination, I am reporting my... Read more
Janssen COVID-19 Vaccine EUA Based on the paperwork I received at my vaccination, I am reporting my side effects for your records. I received the dose (1805029) on 3/12/2021 (Friday) at 4:30 in the afternoon. At around 10:30 p.m. I began to feel unwell with chills, shaking/tremors of my hands/arms, and overall aches. I had trouble sleeping through the night due to these symptoms in addition to night sweats (fever). These conditions persisted through the next day (Saturday) and evening (24 hours). I managed to sleep 8 hours and had only a headache the following morning (Sunday). I treated my symptoms by taking Tylenol which was helpful. Hope this helps with your research/records.
63 2021-03-14 feeling hot Approximately an hour and a half after getting the vaccine, I noticed my hands swelling, then my jaw... Read more
Approximately an hour and a half after getting the vaccine, I noticed my hands swelling, then my jaws started aching, then they felt like they were swelling, along with my cheeks going down my neck, then I got a great deal of pressure, swelling, in my ear drums. I was speaking with a friend, who is a nurse, and she told me to take a Benedryl, so I ate a 12.5 milligrams children's chewable diphenhydramine. Twenty minutes later I felt normal again. Later that evening I noticed the palms of my hands were very hot. I did not have any fever. That passed the next evening.
63 2021-03-14 tremor, muscle spasms About 5 hours after the injection I started feeling funny. About 6 hours after the injection I had ... Read more
About 5 hours after the injection I started feeling funny. About 6 hours after the injection I had severe chills and shaking / spasms that were so severe I couldn't even hold or drink a glass of water. I believe I was running a high fever and was having trouble keeping the thermometer in my mouth because of the spasms but it did get up to 103.4. By morning, my temperature was down to 99.9 and I continued to run a temperature for 48 hours. My normal temperature is 97.2. I also had for fatigue for about 5-6 days but it was minor.
63 2021-03-14 tremor Patient felt light-headed and dizzy 15 minutes after receiving the vaccine. She also felt like her h... Read more
Patient felt light-headed and dizzy 15 minutes after receiving the vaccine. She also felt like her hand was shaking. Her forehead and cheeks appeared to be red and flushed. Her symptoms did not improve, she was evaluated by the ID physician and was transferred to the ER.
63 2021-03-15 tingling Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generali... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient reported to our store 5457 about a vaccine she got at 5434 last monday. She broke out with a rash the thursday after getting the vaccine and after a few days of vaccine she decided to go to urgent care since the \"burning wasn't stopping\" and it spread to her chest. She was discharged with a script of prednisone and the rash seems to be getting a little better. I will follow up with her in 2 days to make sure it has cleared up.
63 2021-03-16 weakness Received shot on 3/11/2021 felt okay, a little tired. 3/12 extremely tired - no energy, 3/13 felt a... Read more
Received shot on 3/11/2021 felt okay, a little tired. 3/12 extremely tired - no energy, 3/13 felt a lot better but had a little sore throat, 3/14 extremely tired sore throat mucus drainage down throat, 3/15 tired no energy, sneezing, dry cough, 3/16 tired no energy sneezing dry cough. Today 3/17 finally feeling better but still a little tired.
63 2021-03-16 numbness, tingling, tenderness March 13, 2021-1:30pm-Shot administered to right arm-it bled and the nurse had to apply pressure wit... Read more
March 13, 2021-1:30pm-Shot administered to right arm-it bled and the nurse had to apply pressure with an alcohol swab. It stopped immediately. 1:40-started feeling a tightness in the muscle in my neck under my right ear Stayed a few minutes longer than the required 15 to see if anything else presented. Mentioned it to the nurse and rep. The rep asked if I was nervous about getting the shot. When I said yes, he said it may just be that. Told me to contact my doctor with additional issues. 1:55-When leaving the parking lot, I felt my lips and nostril on the right side go numb-it felt like when Novocain is wearing off after a dentist visit. As the day progressed, the area under my ear and down my neck got more and more sensitive. My lips continued to feel numb. My injection site was tender and black and blue. When I went to bed at 9pm, I began experiencing lots of pain in my right lower jaw. I took a Tylenol but it didn't alleviate the pain. I called on-call doctor. Since I already had taken a Tylenol, he suggested an anti-inflammatory and warm moist compresses and to contact him again if things worsened. 3/14/21-7:00am-Upon awaking, my jaw pain was virtually gone but the whole area I had had the issue with was very tender to the touch. My lip still felt a bit numb. 3:25pm- It is now 26 hours since my vaccination. I still feel like I had trauma to the right side of my face and neck because it is sensitive to the touch. I also have a continued slight sensitivity of my lips on the right side. My glands on both sides of my neck now seem tender, as well. 3/15/21-3/17/21-I continue to have random pain/tenderness in the aforementioned areas. I also have an aura of tingling in my brain from time to time.
63 2021-03-16 migraine Pain at injection site persisted for ~1 hr; 3 hrs. post vaccine -> mild headache; 6 hrs. post vaccin... Read more
Pain at injection site persisted for ~1 hr; 3 hrs. post vaccine -> mild headache; 6 hrs. post vaccine -> serious migraine with myalgia focused on neck and upper back and chest muscles (muscle knots developed and could be felt) -> slight fever (0.6 degrees F above normal); 7 hrs post-vaccine -> serious chills that shook entire body and would not stop for 30 minutes (similar to the kind I had when I had hypothermia at age 18); 8 hrs post-vaccine -> nausea; I took tylenol then and within 45 minutes everything except headache, myalgia and muscle knots, and nausea went away. Vomited in middle of the night. Felt very drained and tired with myalgia all of the next two days. Majority of symptoms went away after that but I felt as if I was coming down with a cold for the next 7 days - today my nose has been running all day and I have a stuffed head (and I have not had a cold since November 2019). I had a covid test yesterday because I need to accompany my husband for a medical procedure on Friday - that was negative. I have seen no one, gone nowhere, and done nothing different since I received my vaccine than I had beforehand yet I am displaying symptoms normally associated with a cold although I have no fever.
63 2021-03-18 tingling fatigue and occasional tingling on L side on mid. back, no rash
63 2021-03-19 weakness chills for approximately 12 hours, thru the night; back muscular pain for same amount of time. weak... Read more
chills for approximately 12 hours, thru the night; back muscular pain for same amount of time. weak.
63 2021-03-21 weakness Approximately 3 hours after my injection I became very lethargic and my heart began to race. I had ... Read more
Approximately 3 hours after my injection I became very lethargic and my heart began to race. I had fever of 101 and became very weak and tired. I experienced nausea, pain in my upper back and my heart raced for approximately 10 hours. On Tuesday, March 16, 2021 I slept on and off for the entire day and continued to have a fever. My heart rate came down within 24 hours after my injection and the fever came down to normal 36 hours after the injection. I felt weakness for approximately 3 days after the injection. I am currently recovered from all symptoms as of March 22, 2021.
63 2021-03-21 slurring, numbness, inability to speak Just walked in the house from work. Sudden total numbness of left arm. Had hard time speaking, words... Read more
Just walked in the house from work. Sudden total numbness of left arm. Had hard time speaking, words were slow coming out and were slurred. After about 10 minutes the numbness gave way to weakness. The speech was improving but slurred slightly for another 20 minutes. Checked out by emt's and paramedics, then husband drove me to hospital.
63 2021-03-22 weakness Patient came in to the pharmacy complaining of dizziness and weakness. She was having trouble stand... Read more
Patient came in to the pharmacy complaining of dizziness and weakness. She was having trouble standing up from seated position and walking in a straight line. Her husband was going to take her to the emergency room after leaving here. I had her smile and it was even. She said that she was ok the day before, but developed these symptoms 2 days after vaccination.
63 2021-03-22 weakness Patient came in complaining that she was having weakness and dizziness. She was having trouble stan... Read more
Patient came in complaining that she was having weakness and dizziness. She was having trouble standing up from seated position. She was also having trouble walking in a straight line. Her husband was with her and drove her to the ER after leaving the pharmacy.
63 2021-03-23 feeling cold Immediately after receiving the vaccine, stood up and felt dizzy and could feel headache moving to m... Read more
Immediately after receiving the vaccine, stood up and felt dizzy and could feel headache moving to my scalp. At bedtime, around 10:30 pm, I could not fall asleep, was freezing, achy, in and out of sleep. Took temperature at around 2:00 AM. My temp was 102 deg. F, my pulse was at 125 bpm. I could feel my heart rate beating rapidly. Was still dizzy. At around 6:30 AM, my temp was 101.9 deg. F. Stayed home from work. Got out of bed around 2:00 PM. As I went to the restroom during the morning, early afternoon, my temp gradually decreased, my heart rate gradually decreased. Still had headache. Was very fatigued. The next day, my temp was normal, had mild headache and was still fatigued.
63 2021-03-23 pain in extremity Received the J+J Janssen vaccine on Sunday 3/14/21. On Friday 3/19/21 developed bilateral lower leg ... Read more
Received the J+J Janssen vaccine on Sunday 3/14/21. On Friday 3/19/21 developed bilateral lower leg discomfort and red spots on outer part of shin. On Sunday 3/21/21 noted increase in swelling both feet and lower legs with pain and rash waist down. Patient went to ER for evaluation. Started on prednisone. Dx: Vasculitis On Monday 3/22/21 evaluated by PCP. Follow up blood work and office appointment in 8 to 10 days. Report to VEARS. Awaiting patient call back to complete form. On Wednesday 3/24/21 patient returned call. Reports joint aches, right side decreased swelling, left foot and hand remains slightly swollen. Purple skin discoloration remains on lower extremities but decreased pain. VEARS form submitted.
63 2021-03-24 pain in extremity The shot made my arm very sore for about an hour. When I went to sleep that night, I experienced fee... Read more
The shot made my arm very sore for about an hour. When I went to sleep that night, I experienced feeling chilled all night long. It ended by morning. I had one bought of mild diahrea the next morning. Then all was fine.
63 2021-03-24 tremor I exp shaking and headache lasted few hours . I went to the doctor on 3/17 had a UTI(which is not no... Read more
I exp shaking and headache lasted few hours . I went to the doctor on 3/17 had a UTI(which is not normal for me).
63 2021-03-25 feeling hot Felt "hot" and dizzy 5 minutes after receiving vaccine.
63 2021-03-25 tingling On 3-22 11 days after vaccination), patient presented with lower extremity weakness and uper extremi... Read more
On 3-22 11 days after vaccination), patient presented with lower extremity weakness and uper extremity paresthesias
63 2021-03-27 pain in extremity Slight soreness in right arm. Headache (which lasted 2 days), nausea, muscles aches, fatigue (which ... Read more
Slight soreness in right arm. Headache (which lasted 2 days), nausea, muscles aches, fatigue (which lasted 12 hours or so).
63 2021-03-27 tremor, feeling cold severe headache. both inner ears ached. trembling - could not get warm. entire body ached - even ... Read more
severe headache. both inner ears ached. trembling - could not get warm. entire body ached - even my fingers
63 2021-03-29 feeling cold 19 hours later I got cold and started Wheezing 20 hours later slight chest pressure after taking ve... Read more
19 hours later I got cold and started Wheezing 20 hours later slight chest pressure after taking ventolin inhaler
63 2021-03-31 pain in extremity Pain injection site since day of vaccination, still have pain. Slight fever and chills, body aches,... Read more
Pain injection site since day of vaccination, still have pain. Slight fever and chills, body aches, fatigue for 12 hours.
63 2021-04-01 weakness At 3 am when I woke to urinate, I was very loopy in the head as if I had not slept at all for 24 hou... Read more
At 3 am when I woke to urinate, I was very loopy in the head as if I had not slept at all for 24 hours. Kind of dizzy feeling. The next morning I was very tired. As time progressed, I felt like I HAD to be horizontal. No energy at all. No appetite at all. Took my temperature and was shocked to see it at 101.4º. Pharmacist suggested I take aspirin, which I took one, and then another one several hours later. It did help and reduced the fever to 99º. The following day the temperature remained at 99º but under 100º. (I never took any other aspirin other than the two that I mentioned). The third day I was good to go!
63 2021-04-02 weakness next day felt very tired, was fine 2 days until Monday-Wed got headache-pressure in head, felt woozy... Read more
next day felt very tired, was fine 2 days until Monday-Wed got headache-pressure in head, felt woozy, stomach was queasy, very low energy, croupy cough, nose runny, no stamina for long walks Was ok 2 days and then it started again off and on till 3/31. Sometimes stomach felt sick, couldn't eat much. Finally feeling better in stomach but still getting headaches. Still have little stamina and very low energy and headaches make it hard to think, runny nose, croupy cough comes and goes. Teleconference with Dr. on 3/23/2021 Saw family Dr. 4/2/2021. Saw no urgent needs, just noted side effects
63 2021-04-03 feeling cold, muscle spasms Severe headache, chills and fever, muscles aches, muscle spasms. Headache, chills and fever lasted ... Read more
Severe headache, chills and fever, muscles aches, muscle spasms. Headache, chills and fever lasted until about 5am 4/2/2021. Muscle spasms lasted until about noon on 4/2/2021 and muscle aches lasted until about 7am 4/3/2021. Took Tylenol which didn't affect symptoms until the second dose.
63 2021-04-04 feeling of body temperature change 2 days post vaccine, woke up with a rash to bilateral palms and arms that stop at the shoulder. sma... Read more
2 days post vaccine, woke up with a rash to bilateral palms and arms that stop at the shoulder. small maculopap bumbsular from palms to shoulder, skin is sensitive to hot and cold, rash is "itchy and painful," denies skin peeling, took zytrtec with no relief, also complains of low energy/fatigue, appetite is ok, denies fever, approximately 12 hours later noticed rash to abdominal region, same maculopapular bumbs across bilateral upper abdoment, denies shortness of breath
63 2021-04-05 numbness, burning sensation, nerve pain March 4 - J&J Covid Vaccination March 5 - Woke up feeling terribly under the weather; sinus inflamm... Read more
March 4 - J&J Covid Vaccination March 5 - Woke up feeling terribly under the weather; sinus inflammation/chills/fatigue/pressure in ears/pain in teeth (upper back molars), swollen glands - just plain "ill" Week of March 8 - See above, the same March 9 - Appointment at Primary Care Clinic due to March 5th symptoms and a 1-day bout of diarrhea Diagnosis ?cold, sinus issues? - try Mucinex/Tylenol / Covid Test = Negative Mid-March: fever blister appears for a few days and ringing in my ears (noise) increases. Fever blister lasts about 4 days. Week of March 15 - Same Symptoms as March 5 plus another 1-day bout of diarrhea Sunday, March 21 - stomach cramps / diarrhea - chills/overwhelming fatigue - same sinus issues as March 5 Week of March 22nd - equilibrium is off and starts to become an issue - 3 nights of vertigo but not severe during that week. Last vertigo attack was in 2018. March 28th - sinus situation the same, diarrhea again, start Pepto Bismol regime based on past microscopic colitis issues Mucus is thin and clear, just started to discharge. March 31st - Schedule another appt at Primary Care Clinic due to ?status quo? - this doctor thinks inflammation and prescribes prednisone (2) 20 mg for 5 days - Covid Test / Strep Test / Influenza Tests = Negative March 31 - April 4 / Prednisone: Visibly more stuffed up. Tooth/nerve pain increased from a 3 to a 7; didn't take the final days dose. After stopping my head felt numb. Vertigo stopped; equilibrium still off. Increased tinnitus and increased pressure/burning under my eyes and around my cheekbones. April 5 - 6 - New symptom appeared approximately a week ago; tightness in throat, difficulty swallowing. Still experiencing tooth nerve pain (sinus cavities). Woke up soaked the last 2 nights. Noticed increased difficulty concentrating "brain fog".
63 2021-04-05 tremor Shortly after the vaccine my tongue begin feeling really thick and furry. Moments later my lips beg... Read more
Shortly after the vaccine my tongue begin feeling really thick and furry. Moments later my lips began tingling causing me to seek medical attention. My body got really shaky and I got really anxious but after about 45 minutes my body returned back to its normal state. Later that day and up into that Saturday I was very fatigued, nauseous and the body aches were severe.
63 2021-04-06 weakness DIZZINESS; FACE SWELLED; THROAT CLOSING; CHEST TIGHTNESS; ITCH IN EAR; HEART BEAT RACING; WHEEZING; ... Read more
DIZZINESS; FACE SWELLED; THROAT CLOSING; CHEST TIGHTNESS; ITCH IN EAR; HEART BEAT RACING; WHEEZING; WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, non alcoholic, penicillin allergy, and sulfonamide allergy, and other pre-existing medical conditions included the patient had anaphylaxis with tetanus booster shot 4 years ago. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: unknown) dose was not reported, administered on 31-MAR-2021 at 12:18 p.m. vaccinated on left arm for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy, and fluticasone propionate for allergy. On 31-MAR-2021, the subject experienced dizziness. On 31-MAR-2021, the subject experienced face swelled. On 31-MAR-2021, the subject experienced throat closing. On 31-MAR-2021, the subject experienced chest tightness. On 31-MAR-2021, the subject experienced itch in ear. On 31-MAR-2021, the subject experienced heart beat racing. On 31-MAR-2021, the subject experienced wheezing. On 31-MAR-2021, the subject experienced weakness. Laboratory data included: Blood pressure (NR: not provided) Unknown. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, face swelled, throat closing, chest tightness, heart beat racing, wheezing, and weakness on 31-MAR-2021, and had not recovered from itch in ear. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
63 2021-04-06 pain in extremity, feeling cold, facial pain, discomfort Pt developed throat discomfort. Was given benadryl 25 mg po x1. BP 153/69, HR 65, O2sat 100%. Respir... Read more
Pt developed throat discomfort. Was given benadryl 25 mg po x1. BP 153/69, HR 65, O2sat 100%. Respirations appeared normal. Also reported arm pain radiating up to left side of face and tight chest pressure. Was given 2 puffs of albuterol inhaler. Pt stated throat felt better at this time. Repeat BP 135/59, HR 64, O2sat 99%. Pt felt shaky and cold, possibly from albuterol. Pt stated chest tightness subsided but still continued to have weird sensation in her arm up to her jaw area and throat was still feeling funny. Repeat VS 123/61, HR 61, O2sat 100%. Was taken to ER via W/C. Pt c/o being dizzy and throat was tightening up again on the way to ER. Was given solumedrol in ER. Discharged home. Feels better but still has some left throat swelling, improved with steroids, antihistamine. Airway unaffected. Chest tightness/pressure resolved.
63 2021-04-07 discomfort Janssen COVID-19 Vaccine EUA: 18 hours after getting the vaccine i began to feel dizzy, then got ch... Read more
Janssen COVID-19 Vaccine EUA: 18 hours after getting the vaccine i began to feel dizzy, then got chills and body aches. There was no fever. Very uncomfortable though shivering under blankets in 72 degree weather. I expect the symptoms to lessen, have taken tylenol at 7:30pm and feel a little better now.
63 2021-04-07 hot flush less than ten minutes after administration of JJ vaccine, patient started to complain of nausea, pal... Read more
less than ten minutes after administration of JJ vaccine, patient started to complain of nausea, palpitations, and a "warm flush feeling", but the patient did not exhibit any signs of visible color change. All of the stated symptoms appeared with rapid onset together over a period of 1 to 2 minutes, then started to reside. Patient was given 25mg diphenhydramine and stabilized. Patient instructed to wait additional 30 minutes in pharmacy and had no additional symptoms and stated she felt ok prior to leaving. Follow up phone call 4/7/2021 and patient stated she experienced no additional or subsequent events/symptoms.
63 2021-04-07 muscle spasms Head pounding My entire body muscles felt like I had been beat up. Blankets were difficult move st... Read more
Head pounding My entire body muscles felt like I had been beat up. Blankets were difficult move stretching/ spasms were strong and long. Took two pain killers my low back felt so bad I wasn?t sure if I could walk to bed. Rough night still have a bad headache low back ~ hips hurts to bend over.
63 2021-04-08 weakness RACING HEARTBEAT; DIZZY; CHILLS; WEAKNESS; HEADACHE; FEVER; MUSCLE ACHE; NAUSEA; FATIGUE; This spont... Read more
RACING HEARTBEAT; DIZZY; CHILLS; WEAKNESS; HEADACHE; FEVER; MUSCLE ACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced racing heartbeat. On 01-APR-2021, the subject experienced dizzy. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced weakness. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Heartbeats increased (NR: not provided) 144 /min. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) 21 BMI. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heartbeat, weakness, fever, muscle ache, and nausea on 02-APR-2021, and headache on 03-APR-2021, was recovering from chills, and had not recovered from fatigue, and dizzy. This report was non-serious.
63 2021-04-08 feeling cold, migraine That evening about 11:00 pm I became extremely cold, teeth chattering , complete body ache , nauseat... Read more
That evening about 11:00 pm I became extremely cold, teeth chattering , complete body ache , nauseated and had a slight headache. The next morning about 6:30am I had a major headache I can only describe as a migraine times 10. All day and all night. Did not go away at all . The next day it was very very slight and by the evening the headache was gone.
63 2021-04-08 feeling hot, flushing Patient is found with secondary provider reporting the patient had an episode of syncope and hypoten... Read more
Patient is found with secondary provider reporting the patient had an episode of syncope and hypotension. Patient reports that she is hot, diaphoreticand dizzy after receiving J&J Vaccine. A 12 lead ECG is completed as noted in chart. Patient's vitals are taken as noted in chart. Patient reports that she is beginning to feel better, patient continues to be monitored by EMS. Patient is found A&O x4, flushed warm and diaphoretic. Patient has no noted neurological deficits, pupils are PERRL. No trauma is noted to patient's face. Airway is patent, respirations are as noted. No JVD is noted, trachea is midline. Patient has equal chest rise/fall, lung sounds are equal bi-laterally. Patient denies chest pain, shortness of breath. Abdomen is soft/non tender. Patient denies abdominal pain, no GI/GU Symptoms are noted. Patient has no deficits noted to extremities, pulses are strong. Patient denies covid 19 concerns, other injuries or illness. 12 lead ECG is taken showing sinus rhythm as noted in chart
63 2021-04-08 muscle spasms last night had leg cramps and then all over body pain that lasted for about an hour. took a shower ... Read more
last night had leg cramps and then all over body pain that lasted for about an hour. took a shower and the spray stung but eventually pain stopped husband doesnt care and would not take to dr
63 2021-04-09 pain in extremity very sore upper arm for about 1/2 hour after 5 hours quickly increasing fever and uncontrolable shiv... Read more
very sore upper arm for about 1/2 hour after 5 hours quickly increasing fever and uncontrolable shivers for 1 hour after 8 hours fever topped at 101.7 continueing nausia and fatigue the next day with low fever and low appetite continuing nausia and fatigue the third day tinitus the third night lingering fatigue and low appetite the forth day (today)
63 2021-04-09 tingling, pain in extremity Blood glucose 158 mg/dL; Blood pressure 177/102 mmHg; Heart rate 92 bpm, Sp02 98%; Per spouse her h... Read more
Blood glucose 158 mg/dL; Blood pressure 177/102 mmHg; Heart rate 92 bpm, Sp02 98%; Per spouse her head, arms, and chest hurt; arms have itching and tingling. Client's spouse reports she had a similar reaction and it is "less than last time" and was recommended by her PCP to receive a dose of Janssen instead of a second dose of the Moderna (received 1st dose on 01/16/21 Moderna 013L20A).
63 2021-04-11 weakness, tremor Immediate moderate pain at injection site. 6 hours post injection: severe body aches, chills, tremo... Read more
Immediate moderate pain at injection site. 6 hours post injection: severe body aches, chills, tremors, weakness lasting 36 hours. Generalized fatigue and weakness continuing for 4 days.
63 2021-04-11 facial paralysis, bell's palsy Developed right facial droop in the hospital, lead to a new diagnosis of Bell's Palsy (MRI no evi... Read more
Developed right facial droop in the hospital, lead to a new diagnosis of Bell's Palsy (MRI no evidence for stroke, CT no acute abnormality) She has Johnson and Johnson Vaccine and she is currently hospitalized after a fall at home
63 2021-04-11 numbness, tingling Johnson-Johnson COVID-19 Vaccine EUA-- on 3/31/21 client presented at clinic 0750 for vaccine, compl... Read more
Johnson-Johnson COVID-19 Vaccine EUA-- on 3/31/21 client presented at clinic 0750 for vaccine, completed paperwork and COVID vaccine administered by guardsman and given time she may leave. She stayed longer due to questions and her sister getting vaccine also. I had to call PCP for sister to get vaccine due to medical issues. I could not get through to PCP informed her I would call her. I called to tell them they would need to call her sister's PCP At about 0846 she stated she was not feeling well. Stated she thinks her right side may be numb-tingling and right side of face. Informed her to go to ER if she thought she was having an allergic reaction or call 911. She stated she was in ER parking lot now. Stated her PCP wanted her to have this vaccine and she is allergic to Epinephrine, informed her to tell ER what she just told me and that she had received the COVID vaccine. At 3:00 PM client called and asked if predisone she got in ER would elevate her BP. She stated ER papers say paresthesia of skin, TIA vs allergic reaction to vaccine, work up TIA symptoms and sent home to follow up with PCP.
63 2021-04-11 pain in extremity SORE ARM; JOINT MUSCLE ACHE; HEADACHE; NAUSEA; DIARRHEA; DIZZINESS; This spontaneous report received... Read more
SORE ARM; JOINT MUSCLE ACHE; HEADACHE; NAUSEA; DIARRHEA; DIZZINESS; This spontaneous report received from a patient concerned a 63-year-old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at 10:10 in left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 10:25, the subject experienced dizziness. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced sore arm. On 07-APR-2021, the subject experienced joint muscle ache. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: bismuth subsalicylate/calcium carbonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 07-APR-2021, and had not recovered from headache, joint muscle ache, nausea, dizziness, and sore arm. This report was non-serious.
63 2021-04-11 tremor Received the shot at 11 am and had felt fine all day. Arm was sore a vaccine site but that's it ... Read more
Received the shot at 11 am and had felt fine all day. Arm was sore a vaccine site but that's it Then around 10 pm I started to get chills. Within 10 minutes of this I felt violently ill. The chills amd shaking were intense. I began vometing and had severe intestinal issues. This attack came on fierce and lasted until 4 am. I was sweating and shaking at the same time and for at lease 6 hours. My body felt tired and drained. I never expected to be so sick. The following day my symptons had began to go away for the most part, headache and feeling drained continued for a few more hours.
63 2021-04-12 weakness Dizziness, weakness, digestive system issues, loose stools, active bowels actively with gas. 5 minu... Read more
Dizziness, weakness, digestive system issues, loose stools, active bowels actively with gas. 5 minutes after injection I noted pain below both of my ears and visual disturbances. Nausea with the taste of bile in my mouth
63 2021-04-12 weakness Hello, I received my J&J vaccine on 3/31/2021. 11:00a.m. Here is my results: 3/31/21 Day1: Waited 3... Read more
Hello, I received my J&J vaccine on 3/31/2021. 11:00a.m. Here is my results: 3/31/21 Day1: Waited 30 mins at site due to the history of Penicillin and Sulfa issues in the past. I had a little itching at the shot site. That went away in about 15 mins. Late afternoon I had a slight headache. 4/1/21 Day 2: Morning was normal. Afternoon I started feeling a little sluggish. I had a little headache. 4/2/21 Day 3: Morning was slow. I noticed that I was tired. Headache was stronger. I took Ibuprofen 400mg. By mid day, I was on the couch the rest of the day. My body was telling me to rest. So I did.
63 2021-04-12 pain in extremity Severe headache unable to go to work for one day Still not up to my normal abilities two weeks lat... Read more
Severe headache unable to go to work for one day Still not up to my normal abilities two weeks later. More fatigue than usual. Right and left leg pain and right arm pain. Possible DVT but not tested have had in the past so feels that way
63 2021-04-12 pain in extremity 4/4/21 Swelling below waist, including buttocks, hips, thighs, and knees. Severe itching and pain. 4... Read more
4/4/21 Swelling below waist, including buttocks, hips, thighs, and knees. Severe itching and pain. 4/7/21 Swelling spread to calves and ankles. Severe pain and itching. PCP prescribed 50 mg Benadryl every 6 hours and was told to go to Urgent Care if symptoms persist. 4/9/21 Went to Urgent Care Clinic due to excruciating pain in legs. Admitted to accompanying ER. Received IV and had blood drawn, showing extremely low platelet levels (37k). Discharged with prescription for antihistamine, steroid, and hydroxyzine HCL. Ultrasound taken but did not show blood clots. 4/11/21 Pain and itching spread to both arms. Extreme pain when standing and walking. 4/13/21 Went to ER. Ultrasound confirmed multiple blood clots. Discharged with prescription for Xarelto.
63 2021-04-12 tremor BAD PAIN ON RIGHT SIDE (TOWARDS THE BACK); SWOLLEN NOSTRILS (INSIDE); Shaking; HARD TO WALK; Fever;... Read more
BAD PAIN ON RIGHT SIDE (TOWARDS THE BACK); SWOLLEN NOSTRILS (INSIDE); Shaking; HARD TO WALK; Fever; Nausea; Chills; JOINT PAIN (KNEES, ELBOWS, SHOULDERS, HIPS, FINGERS, ANKLES); HEADACHE THAT FELT LIKE A SLEDGE HAMMER; SORENESS AT INJECTION SITE; EXTREME THIRST; Loss of taste; LOSS OF APPETITE; SWOLLEN HANDS; Runny nose; EYES CRUST AROUND THE EDGES; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced extreme thirst. On 03-APR-2021, the subject experienced loss of taste. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced swollen hands. On 03-APR-2021, the subject experienced runny nose. On 03-APR-2021, the subject experienced eyes crust around the edges. On 03-APR-2021, the subject experienced joint pain (knees, elbows, shoulders, hips, fingers, ankles). On 03-APR-2021, the subject experienced headache that felt like a sledge hammer. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021 22:00, the subject experienced shaking. On 03-APR-2021 22:00, the subject experienced hard to walk. On 03-APR-2021 22:00, the subject experienced chills. On 03-APR-2021 22:00, the subject experienced fever. On 03-APR-2021 22:00, the subject experienced nausea. On 05-APR-2021, the subject experienced swollen nostrils (inside). On 05-APR-2021 14:00, the subject experienced bad pain on right side (towards the back). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose on 05-APR-2021, and bad pain on right side (towards the back) on 05-APR-2021 21:00, was recovering from hard to walk, joint pain (knees, elbows, shoulders, hips, fingers, ankles), and swollen hands, had not recovered from swollen nostrils (inside), and the outcome of shaking, chills, fever, nausea, extreme thirst, loss of taste, loss of appetite, headache that felt like a sledge hammer, soreness at injection site and eyes crust around the edges was not reported. This report was non-serious.
63 2021-04-13 pain in extremity BLURRED VISION, HEADACHE, CHILLES, SEVERE PAIN IN RIGHT ARM, SHOULDER AND BACK FOR DAYS. STILL HAVIN... Read more
BLURRED VISION, HEADACHE, CHILLES, SEVERE PAIN IN RIGHT ARM, SHOULDER AND BACK FOR DAYS. STILL HAVING BLURRED VISION AND LITTLE HEADACHES
63 2021-04-13 pain in extremity Patient states that on 4-10-21 she developed a severe pain in her right knee. Patient states that th... Read more
Patient states that on 4-10-21 she developed a severe pain in her right knee. Patient states that the pain radiates from her thigh to her knee and sometimes down her leg. Feels a tightness in her leg and knee, No noted swelling of discoloration of the area.
63 2021-04-13 pain in extremity Dark bruising at injection site Arm and hand pain
63 2021-04-13 tremor On March 8th received the J&J shots, March 9, 10th & 11th was extremely nauseous in the morning. On... Read more
On March 8th received the J&J shots, March 9, 10th & 11th was extremely nauseous in the morning. On the 12th had severe chest pains which I chalked up to a very bad case of heart burn. On March 24th, while driving I had two major (what I thought at the time) was panic attacks...body started shaking, heart was beating like crazy, couldn't catch my breath, felt like I was going to pass out or die. Had to pull over twice to calm myself down. (From what I read this could be a sign of a blood clot but I am not a doctor.) Had minor heart burn until April 5th....which ironically was the end of my 28 days until the vaccine fully kicked in. Just reporting what happen. I feel fine now.
63 2021-04-14 facial pain Woke up with black eye that began in corner of left eye and progressed down to middle of lower lid, ... Read more
Woke up with black eye that began in corner of left eye and progressed down to middle of lower lid, later that day I had sudden onset of throbbing pain on left side of upper gum and cheek area. The pain in mouth would come and go and responded to heat pack and extra strength Tylenol. I also had a headache on the left side of my head. The black eye went away in about three days. The mouth pain went on off and on for about 7 days gradually subsiding in intensity over that time frame. The headache only lasted for a few days. I also felt some pressure behind my left eye.
63 2021-04-14 feeling cold, bell's palsy My symptoms started 03-18-2021 at 11am where I developed chills, was very sleepy that I slept 15 hou... Read more
My symptoms started 03-18-2021 at 11am where I developed chills, was very sleepy that I slept 15 hours straight. I felt very fatigued and my eyes hurt so much and I could not keep them open. On 04-06-2021 I still was not feeling well. I started to have problems with my right side of my face, eyes and mouth which gradually got worse so I went to the hospital. At the hospital they checked me for stroke, performed lab work, did MRI and CT scans and the the doctors came back and said it was Bell's palsy. I again went to the hospital 04-11-2021 but this time due to GI issues with pain. On 04-14-2021 through 04-15-2021, I started to experience neck pain behind my right ear. At the hospital they had prescribed my prednisone 50mg, so I took half for my pain. I still have trouble sleeping and have lots of pain.
63 2021-04-14 feeling cold TASTE OF MEDAL IN MOUTH AT TIME OF VACCINE FELT FLUID OF SHOT ENTERING MY ARM CHILLS FOR 6 HOURS , N... Read more
TASTE OF MEDAL IN MOUTH AT TIME OF VACCINE FELT FLUID OF SHOT ENTERING MY ARM CHILLS FOR 6 HOURS , NO FEVER NUERLOGICAL SENSAATION IN MY ARMS AND FINGER TIPS THAT CONTINUE SINCE THE VACCINE WAS GIVEN THAT COMES AND GOES. iTS AN ANORING SENSATION MORE THEN PAINFUL.
63 2021-04-14 migraine Headaches, blurry vision right after she took the vaccine. She has history of migraines but these he... Read more
Headaches, blurry vision right after she took the vaccine. She has history of migraines but these headaches and blurry vision are more frequently occuring.
63 2021-04-14 pain in extremity She presents to ED on 04/14/2021 with complaints of altered mental status and rash. Patient states t... Read more
She presents to ED on 04/14/2021 with complaints of altered mental status and rash. Patient states that she went to work on Saturday, she is a food server, she started to feel not herself and felt like she ?snapped?. She states that on the way home in her car she was nearly struck by the train crossing barriers. She states that she went home and sat in her recliner on Saturday and did not get up until Wednesday at around lunchtime. She states that she did not get up to eat or drink. She used incontinence pads and depends. She did not get up to use the restroom. She did continue to take her medications. Patient states that she was motivated to get up today because her friends were concerned for her and 1 of her friends came over to take her out for lunch. Elevated D Dimer History of DVT - mild leg pain, no swelling or erythema. No chest pain, cough or SOB. Low suspicion for PE - full dose lovenox - BLE duplex in the morning
63 2021-04-14 tingling Initially began with tingling in hands, feet and lower legs, face. Progressed to full body tingling... Read more
Initially began with tingling in hands, feet and lower legs, face. Progressed to full body tingling with body ?buzzing? like an adrenaline rush. Increased heart rate and blood pressure. Minor tingling continues through this report. No full body experience in last 24 hours.
63 2021-04-15 breast pain Extreme soreness in right breast and throughout by entire body. Vomited after my shower and felt sic... Read more
Extreme soreness in right breast and throughout by entire body. Vomited after my shower and felt sick but this only lasted about an hour and a half. After that, I was wore out, which last a few days. Nothing serious other than the vomiting was tough.
63 2021-04-15 pain in extremity, muscle spasms Starting on about 3/15/21 I started ?getting very uncomfortable pain in my calf on both legs and i... Read more
Starting on about 3/15/21 I started ?getting very uncomfortable pain in my calf on both legs and it lasted 2 weeks. . I do walk 4-5 5 days a week and never experienced this feeling prior. I put heat on my legs massaged the and also used a rolling pin. I never called my dr did not think of it. Just though it was cramping but blood clots did enter my mind but I thought can?t be I am so active.
63 2021-04-15 pain in extremity RAISED AROUND THE INJECTION; WARM TO TOUCH AROUND THE INJECTION; HURTS TO LIFT LEFT ARM; LEFT ARM SO... Read more
RAISED AROUND THE INJECTION; WARM TO TOUCH AROUND THE INJECTION; HURTS TO LIFT LEFT ARM; LEFT ARM SORENESS; REDNESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, high cholesterol, outside weeds allergy, eczema, and hives. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 19-JUL-2021) dose was not reported, administered on 08-APR-2021 16:00 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for thrombolytic event. On 28-DEC-2020, Laboratory data included: Coronavirus test (NR: not provided) Positive. On 08-APR-2021, the subject experienced raised around the injection. On 08-APR-2021, the subject experienced warm to touch around the injection. On 08-APR-2021, the subject experienced hurts to lift left arm. On 08-APR-2021, the subject experienced left arm soreness. On 08-APR-2021, the subject experienced redness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness at the injection site, raised around the injection, warm to touch around the injection, left arm soreness, and hurts to lift left arm. This report was non-serious.
63 2021-04-15 pain in extremity Patient advises that she has been experiencing lower back pain, leg painful and swelling on her righ... Read more
Patient advises that she has been experiencing lower back pain, leg painful and swelling on her right foot, a fogginess that "feels like I'm on a conveyor belt", depression, diarrhea and fatigue since receiving the vaccine. Patient also advises that she used to be able to walk her dogs 4 miles a day and now can barely walk them 20 min. Patient also states that the foot that is painful is also a blueish gray in color.
63 2021-04-15 tremor, weakness, migraine, muscle spasms 4 1/2 hours of severe body tremors and spasms, accompanied by chills. Followed by severe migraine, b... Read more
4 1/2 hours of severe body tremors and spasms, accompanied by chills. Followed by severe migraine, bodyaches and fever. Vomiting and diarrhea began approximately 9:00 AM on April 2, and lasted six hours. Extreme exhaustion and weakness continued until approximately 12 o?clock noon on April 3.
63 2021-04-15 tremor I received the vaccine on a Saturday evening and by Sunday morning, I was sick as a dog with flu lik... Read more
I received the vaccine on a Saturday evening and by Sunday morning, I was sick as a dog with flu like symptoms - massive headache, terrible backache (like someone kicked me in the back), chills and fever. Sunday evening in the middle of the night, in bed, I was shaking so badly from chills that I was afraid to get up to get Tylenol. I finally did and I couldn't even focus my eyesight and control my hands as I went to open the bottle of pills that my hands were shaking so badly that I spilled them all over the place. Finally I woke my husband who heated up blankets in the dryer and brought me hot tea. My husband helped me to the bathroom where I vomited. I cannot remember when I was so sick. I missed work that day at my part-time job and the next day at my full time job as a teacher.
63 2021-04-16 migraine, numbness 1st effect was migraine with left side numbness, woke up at 4 am and was unable to walk correctly. ... Read more
1st effect was migraine with left side numbness, woke up at 4 am and was unable to walk correctly. Went to ER 1 and was transferred due to lack of CT Scan, hospital then admitted for stroke. Can also still feel injection site
63 2021-04-17 night sweats 72 hours later I was hit hard with severe chills, extreme nausea, some vomiting (foam) and diarrhea.... Read more
72 hours later I was hit hard with severe chills, extreme nausea, some vomiting (foam) and diarrhea. Day after vaccine, I had mild symptoms - woke up with mild chills and was very tired - slept most of the day. Following night I had the worst night sweats ever - woke up drenched.
63 2021-04-18 facial pain, night sweats SOME AUTOIMMUNE EFFECTS; Tooth pain; Night sweats; STOMACH BURNING SENSATION; DIFFICULTY SWALLOWING;... Read more
SOME AUTOIMMUNE EFFECTS; Tooth pain; Night sweats; STOMACH BURNING SENSATION; DIFFICULTY SWALLOWING; PRESSURE CHOKING; VERTIGO; Facial pain; SUSPECTED PRODUCT CONTAMINATION; FEVER BLISTER; Foggy feeling in head; DIARRHEA; SEVERE STOMACH CRAMPS; SINUS INFLAMMATION; Sensation of pressure in ear; Injection site lump; CHILLS; FELT ILL; INJECTION SITE PAIN; FATIGUE; This spontaneous report received from a patient. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total administered on 04-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, upon vaccination the patient woke up and experienced sinus inflammation, sensation of pressure in ear. On 05-MAR-2021, the patient experienced injection site lump. On 05-MAR-2021, the patient experienced chills, felt ill, injection site pain and fatigue. On 11-MAR-2021, the patient experienced severe stomach cramps and diarrhea. On 22-MAR-2021, the patient experienced foggy feeling in head. On 23-MAR-2021, the patient "believes the vaccine is contaminated", fever blister and facial pain. On 24-MAR-2021, the patient experienced vertigo. On 28-MAR-2021, the patient experienced pressure choking and difficulty swallowing. The patient visited 2 clinics and an ear, nose and throat (ENT) specialist but they were unable to diagnose and they felt there was some autoimmune effects (onset date unspecified). The patient suspected that the vaccine was contaminated based on the news report. On 02-APR-2021, the patient experienced stomach burning sensation. On 04-APR-2021, the patient experienced night sweats. On 05-APR-2021, the patient experienced tooth pain. The patient has been visited two clinic Treatment medications (dates unspecified) included: famotidine for 14 days for pressure choking and difficulty swallowing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach cramps, vertigo on 28-MAR-2021, night sweats on 06-APR-2021, stomach burning sensation on 05-APR-2021, and injection site lump, and injection site pain on 16-MAR-2021, had not recovered from felt ill, sinus inflammation, chills, fatigue, sensation of pressure in ear, tooth pain, foggy feeling in head, pressure choking, and difficulty swallowing, and the outcome of diarrhea, fever blister, facial pain, some autoimmune effects and suspected product contamination was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0 This report involves a patient who experienced sinus inflammation, sensation of pressure in ear, injection site lump, chills, felt ill, injection site pain and fatigue next day after receiving Janssen COVID-19 Vaccine Ad26.COV2.S for prophylactic vaccination. Approximately a week later, the patient experienced stomach cramps and diarrhea and 1.5 weeks later she had foggy feeling in head and "believes the vaccine is contaminated", had fever blister, facial pain and vertigo. Approximately 3.5 weeks after being vaccinated the patient experienced pressure choking and difficulty swallowing. A throat (ENT) specialist was unable to diagnose and they felt there was some autoimmune effects. A month after being vaccinated the patient experienced stomach burning sensation, night sweats and tooth pain. Given the close temporal relationship and the nature of the events, the events of sinus inflammation, sensation of pressure in ear, injection site lump, chills, felt ill, injection site pain and fatigue are considered related to the vaccination. The insufficient information precludes a meaningful medical assessment of the remaining events, including "autoimmune effects". The events will be assessed further when additional information is received.
63 2021-04-19 pain in extremity Date and time of adverse event: 24 March, 2021 3hrs after started arm sore, muscle lakes, fatigued, ... Read more
Date and time of adverse event: 24 March, 2021 3hrs after started arm sore, muscle lakes, fatigued, fever, shortness of breath. All symptoms resolved except shortness of breath, getting better. List all vaccines given on the date listed (including how vaccine was given and where (body site) vaccine was given: Patient states she started to experience symptoms 3 hours after she received her vaccine. Sore arm, muscle aches, fatigue, fever, shortness of breath. All symptoms resolved except shortness of breath which is continuing to improve. She is just calling to report her symptoms, so no one else will take this vaccine.
63 2021-04-20 burning sensation 24 hours after the vaccine I developed a sharp pain on the inside of my left knee, slightly above th... Read more
24 hours after the vaccine I developed a sharp pain on the inside of my left knee, slightly above the knee cap. There was a soft bump in that area. At work the next day I felt more sharp pains and bumps developing around my knees on both legs. The backs of my thighs were also beginning to burn. I contacted the hotline set up at my work for adverse reactions when I got home from work that night. They were concerned and had me call my doctor. My work is onboard an aircraft and she did not want me to fly again without an ultrasound. I had an ultrasound perform on my left leg and the thigh of my right leg. It was normal. Over the next week I would get stinging , painful bumps and used NSAIDS to help. Approximately six days after the shot the burning sensation on my thighs got worst. It spread for the back of my thighs to the front and then to the calves, arms and shoulders in that order, I started taking Benadryl to release the burning. I went to my doctor who sent me for another ultrasound and blood up. Three weeks after the injection the painful stinging bumps are still happening and the burning is on my legs, arms and shoulders. I am going back to the doctor today and talk about prescribing Gabapentin.
63 2021-04-20 tingling On 4/20/2021 around 1 pm patient called the pharmacy and reported intermittent symptoms of severe he... Read more
On 4/20/2021 around 1 pm patient called the pharmacy and reported intermittent symptoms of severe headache, a feeling of tingling and pinching, and nausea. She stated the last symptom of HA 4 days before her call. She was instructed by the pharmacist to promptly call her primary care provider to report symptoms and receive instructions.
63 2021-04-21 involuntary muscle movements Severe headache on the left side of my head. Unable to turn my head to the left or to the right. C... Read more
Severe headache on the left side of my head. Unable to turn my head to the left or to the right. Crackling sound when I move my head. On this day, April 22, my neck movement has improved, I still have a headache and I can still hear my head crack when I move my head to the left or right. and when I look up or down.
63 2021-04-21 night sweats, pain in extremity HEADACHES/PAIN AT THE BACK OF THE HEAD AND BASE OF THE SKULL 3 EPISODES; MILD NAUSEA EXPERIENCED IT ... Read more
HEADACHES/PAIN AT THE BACK OF THE HEAD AND BASE OF THE SKULL 3 EPISODES; MILD NAUSEA EXPERIENCED IT 4 TIMES LAST WEEK AND LAST NIGHT; INCREASED SALIVA/MEDIUM AMOUNT OCCURS DURING NAUSEA EPISODE ONLY; SWEATINESS OCCURRED ONLY AT NIGHT, STATED THAT SHE WOKE UP WITH A WET T-SHIRT IN A COLD SWEAT; CHILLS OCCURRED ONLY AT NIGHT AT THE SAME TIME AS THE FEVER; RIGHT ARM SORENESS; FEVER/FELT HOT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood clot in leg, and concurrent conditions included hypertension, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included diazepam, and fluoxetine hydrochloride. On APR-2021, Laboratory data included: Pain scale (NR: not provided) 5-6/10. On 01-APR-2021, the subject experienced increased saliva/medium amount occurs during nausea episode only. On 01-APR-2021, the subject experienced sweatiness occurred only at night, stated that she woke up with a wet t-shirt in a cold sweat. On 01-APR-2021, the subject experienced chills occurred only at night at the same time as the fever. On 01-APR-2021, the subject experienced right arm soreness. On 01-APR-2021, the subject experienced fever/felt hot. On 01-APR-2021, the subject experienced mild nausea experienced it 4 times last week and last night. On 03-APR-2021, the subject experienced headaches/pain at the back of the head and base of the skull 3 episodes. Laboratory data included: Pain scale (NR: not provided) 8/10. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweatiness occurred only at night, stated that she woke up with a wet t-shirt in a cold sweat, chills occurred only at night at the same time as the fever, right arm soreness, and fever/felt hot on 03-APR-2021, had not recovered from mild nausea experienced it 4 times last week and last night, and increased saliva/medium amount occurs during nausea episode only, and the outcome of headaches/pain at the back of the head and base of the skull 3 episodes was not reported. This report was non-serious.
63 2021-04-21 pain in extremity, weakness FATIGUE; FELT HORRIBLE; SKIN BURNING AND HURTS TO TOUCH/SKIN ON FIRE/PAINFUL SKIN; NAUSEA; CHILLS; D... Read more
FATIGUE; FELT HORRIBLE; SKIN BURNING AND HURTS TO TOUCH/SKIN ON FIRE/PAINFUL SKIN; NAUSEA; CHILLS; DIARRHEA; VOMITTING; LEG HEAVINESS; LEG PAIN/INTERMITTENT PAIN IN HIPS, BACK, DOWN TO MY KNEES; WEAKNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, double lung pneumonia, leg pain, and leg heaviness, and concurrent conditions included arthritis, and fatigue, and other pre-existing medical conditions included patient second shingles shot begins in february. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced leg heaviness. On 2021, the subject experienced leg pain/intermittent pain in hips, back, down to my knees. On 2021, the subject experienced weakness. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced vomitting. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021 16:00, the subject experienced nausea. On 19-MAR-2021 23:00, the subject experienced skin burning and hurts to touch/skin on fire/painful skin. On 20-MAR-2021, the subject experienced felt horrible. On 25-MAR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No clots found. On an unspecified date, the subject experienced fatigue. Treatment medications (dates unspecified) included: calcium chloride dihydrate/fructooligosaccharides/glucose/magnesium chloride hexahydrate/potassium chloride/sodium chloride/sodium lactate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomitting, and nausea on 20-MAR-2021, was recovering from diarrhea, had not recovered from chills, skin burning and hurts to touch/skin on fire/painful skin, leg pain/intermittent pain in hips, back, down to my knees, weakness, fatigue, and leg heaviness, and the outcome of felt horrible was not reported. This report was non-serious.; Sender's Comments: V1:Medical assessment comment not required as per standard procedure as case assessed as non-serious.
63 2021-04-21 pain in extremity leg pain, used ice pack x >12 hours, when removed had rash, patient, went to ED on 4/12/2021 and dia... Read more
leg pain, used ice pack x >12 hours, when removed had rash, patient, went to ED on 4/12/2021 and diagnosed with shingles
63 2021-04-21 pain in extremity SWELLING RIGHT UPPER ARM; CHILLS; PAIN IN RIGHT AND LEFT LOWER LEGS KNEE TO ANKLES/PAIN IN RIGHT UP... Read more
SWELLING RIGHT UPPER ARM; CHILLS; PAIN IN RIGHT AND LEFT LOWER LEGS KNEE TO ANKLES/PAIN IN RIGHT UPPER ARM; HEADACHES; EXTREME FATIGUE; SWEATING; LOSS OF APPETITE; BRAIN FOG; SEVERE STOMACH PAIN; DIARRHEA; COUGH; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included borderline diabetes, without medication, abstains from alcohol, and cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2020, Laboratory data included: PCR (NR: not provided) NEGATIVE. On 02-APR-2021, the subject experienced cough. On 05-APR-2021, the subject experienced sweating. On 05-APR-2021, the subject experienced loss of appetite. On 05-APR-2021, the subject experienced brain fog. On 05-APR-2021, the subject experienced severe stomach pain. On 05-APR-2021, the subject experienced diarrhea. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced pain in right and left lower legs knee to ankles/pain in right upper arm. On 05-APR-2021, the subject experienced headaches. On 05-APR-2021, the subject experienced extreme fatigue. On 07-APR-2021, the subject experienced swelling right upper arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach pain, and diarrhea on 05-APR-2021, had not recovered from cough, headaches, sweating, pain in right and left lower legs knee to ankles/pain in right upper arm, extreme fatigue, loss of appetite, brain fog, and swelling right upper arm, and the outcome of chills was not reported. This report was non-serious.
63 2021-04-22 weakness HIGH BLOOD PRESSURE; HEAD AND NASAL CONGESTION; LOSS SENSE OF TASTE; SOFT STOOLS; BACK AND SIDES ARE... Read more
HIGH BLOOD PRESSURE; HEAD AND NASAL CONGESTION; LOSS SENSE OF TASTE; SOFT STOOLS; BACK AND SIDES ARE HURTING; GOING TO THE BATHROOM 4-5 TIMES PER DAY; SOMETIMES NO STOOL; ACID BUILDUP; FELT WEAK OCCASIONALLY; PHELGM BUILDING UP IN THE LUNGS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hyperacidity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 on right arm for prophylactic vaccination. Concomitant medications included calcium carbonate for acid buildup. It was reported that on 09-APR-2021 evening, the patient started to feel some lightheadedness and congestion. She noted that the lightheadedness happened here and there. She had head and nasal congestion and had snot coming out the nose. She felt like her head was about to explode. There was sort of a snap, crackle, and pop in the head. Her back and sides were hurting. She was going to the bathroom 4-5 times per day, sometimes with no stool, and other times with soft stool.She noted some phlegm building up in the lungs. Coughing was noticeable. She also felt weak occasionally. She had a loss sense of taste. She also had acid buildup and took Tums occasionally but did not take on 13-APR-2021. She had noted high blood pressure and heart rate, but they had gone down due to blood pressure medicine. She had exercised in an attempt to reduce her symptoms. She did not had a healthcare professional. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high blood pressure, had not recovered from head and nasal congestion, weakness, loss sense of taste, going to the bathroom 4-5 times per day, and acid buildup, and the outcome of soft stools, back and sides are hurting, sometimes no stool and phelgm building up in the lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210423813- Covid-19 vaccine ad26.cov2.s-Phelgm building up in lungs. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
63 2021-04-22 pain in extremity, numbness Heart palpitations. Left arm numb where received vaccine numb and still is over 2 weeks later. Left ... Read more
Heart palpitations. Left arm numb where received vaccine numb and still is over 2 weeks later. Left forearm and finger pain. Insomnia for two weeks and still have it.
63 2021-04-23 muscle spasms LACRIMATION; MUSCLE CRAMPS; JOINT ACHES; CHILLS; FEVER; HEADACHE; TIREDNESS AND FATIGUE; This spont... Read more
LACRIMATION; MUSCLE CRAMPS; JOINT ACHES; CHILLS; FEVER; HEADACHE; TIREDNESS AND FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced joint aches. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced fever. On 23-MAR-2021, the subject experienced headache. On 23-MAR-2021, the subject experienced tiredness and fatigue. On 24-MAR-2021, the subject experienced lacrimation. On 24-MAR-2021, the subject experienced muscle cramps. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.6 F, 100.6 F. Treatment medications (dates unspecified) included: magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps, and headache on 24-MAR-2021, was recovering from fever, and chills, and had not recovered from joint aches, tiredness and fatigue, and lacrimation. This report was non-serious.
63 2021-04-23 pain in extremity, weakness got it April 10th First day fine, second-day urine dark, third-day fog and disoriented sensation in ... Read more
got it April 10th First day fine, second-day urine dark, third-day fog and disoriented sensation in my head and double vision, and periods of weakness in hands (now coming and going), lack of appetite, extreme thirst, no fever, no vomiting, pains in my thighs and stomach, middle back pain, Hips, pelvis, 9th day: calves so painful and tight I could not get out of bed, figures swelled up to the point that I could not put on my finds, 10th day my calves are very painful (like the soreness that is felt after someone punches you) Especially right calf. The batch number is 206a21a if I can read it from my card.
63 2021-04-23 pain in extremity SORE ARM; UNEXPECTED BENEFICIAL THERAPEUTIC RESPONSE; This spontaneous report received from a patien... Read more
SORE ARM; UNEXPECTED BENEFICIAL THERAPEUTIC RESPONSE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included left shoulder injury- a "spider fracture" of the "proximal humerus", and muscular pain.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced sore arm. On 16-MAR-2021, the subject experienced unexpected beneficial therapeutic response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and the outcome of unexpected beneficial therapeutic response was not reported. This report was non-serious.
63 2021-04-24 muscle spasms Severe right leg cramps. Extreme pain.
63 2021-04-26 weakness I got sick twice. On 03/24/2021 and 04/25/2021. I got sick the day I took the J & J vaccine on March... Read more
I got sick twice. On 03/24/2021 and 04/25/2021. I got sick the day I took the J & J vaccine on March 24th with 104.1* fever, chills, headache, body aches and weakness. I was sick the entire day on the 25th and came out of it on the 26th. I got sick again on April 26th with fever and weakness 100.8*. It started around 11:45 PM. I was sick the entire day on the 26th and came out of it on the 27th.
63 2021-04-26 pain in extremity From patient to after hours provider with c/o head and leg pain after Johnson & Johnson CVD19 vaccin... Read more
From patient to after hours provider with c/o head and leg pain after Johnson & Johnson CVD19 vaccine. She states symptoms started 24 hours after vaccine and has not resolved. Patient advised to proceed to the nearest ER for evaluation for potential side effect due to J&J vaccine. Patient states understanding.
63 2021-04-26 tingling, restless legs syndrome ANXIETY; HEART RACING; STRANGE FEELING IN LEGS; RESTLESS LEG SYNDROME; NUMBNESS AND TINGLING IN LEFT... Read more
ANXIETY; HEART RACING; STRANGE FEELING IN LEGS; RESTLESS LEG SYNDROME; NUMBNESS AND TINGLING IN LEFT ARM; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and 205A221A expiry: 01-JUN-2023) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced strange feeling in legs. On 07-APR-2021, the subject experienced restless leg syndrome. On 07-APR-2021, the subject experienced numbness and tingling in left arm. On 13-APR-2021, the subject experienced anxiety. On 13-APR-2021, the subject experienced heart racing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from strange feeling in legs, restless leg syndrome, numbness and tingling in left arm, anxiety, and heart racing. This report was non-serious.
63 2021-04-26 cold extremities LEGS FEELING COLD; BLOOD SUGAR LOWER THAN NORMAL; SHOULDER HEAVINESS; BACK PAIN; ARM PAIN AT INJECTI... Read more
LEGS FEELING COLD; BLOOD SUGAR LOWER THAN NORMAL; SHOULDER HEAVINESS; BACK PAIN; ARM PAIN AT INJECTION SITE; TIREDNESS; SLEEPINESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes., hypertension, and non smoker, and other pre-existing medical conditions included patient do not smoke. patient has type 2 diabetes for approximately 17 years. patient also has hypertension. The patient received metformin non-company (prolonged-release tablet, route of admin not reported, batch number: Unk) dose, frequency, and therapy dates were not reported for an unspecified indication. The batch number was not reported and has been requested. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine, atorvastatin, glipizide, hydrochlorothiazide/triamterene, insulin glargine, losartan, and sitagliptin. On FEB-2021, Laboratory data included: Blood test (NR: not provided) Results not specified. On 06-MAR-2021, the subject experienced tiredness. On 06-MAR-2021, the subject experienced sleepiness. On 10-MAR-2021, the subject experienced arm pain at injection site. On 11-MAR-2021, the subject experienced blood sugar lower than normal. On 11-MAR-2021, the subject experienced shoulder heaviness. On 11-MAR-2021, the subject experienced back pain. On 11-MAR-2021 17:44, Laboratory data included: Blood glucose (NR: not provided) 97 (unit not specified). On 12-MAR-2021, the subject experienced legs feeling cold. On 12-MAR-2021 06:00, Laboratory data included: Blood glucose (NR: not provided) 166 (unit not specified). On 12-MAR-2021 16:00, Laboratory data included: Blood glucose (NR: not provided) 79 (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with metformin non-company was not reported. The patient recovered from legs feeling cold on 12-MAR-2021, was recovering from arm pain at injection site, shoulder heaviness, and back pain, and had not recovered from blood sugar lower than normal, tiredness, and sleepiness. This report was non-serious.
63 2021-04-29 muscle spasms I experienced at 12am after my vaccine, got a spasms, took sublingual medication. Three days after I... Read more
I experienced at 12am after my vaccine, got a spasms, took sublingual medication. Three days after I felt really tired and fatigued. On 04-08-2021, I started to have tachycardia and high blood pressure. I went to the ER where they performed triponents, did a CT scan of my abdomen and a chest x-ray. I still continue with tachycardia to this day.
63 2021-04-30 numbness COLD-LIKE SYMPTOMS; COUGH; RIGHT ARM PAIN AT THE INJECTION SITE; FEVER; FATIGUE; HEADACHES; LEFT FOO... Read more
COLD-LIKE SYMPTOMS; COUGH; RIGHT ARM PAIN AT THE INJECTION SITE; FEVER; FATIGUE; HEADACHES; LEFT FOOT NUMBNESS/ NUMBNESS UP TO THE LEFT KNEE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included attention deficit disorder, back pain, cigarette smoker, and cough, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced left foot numbness/ numbness up to the left knee. On 25-MAR-2021, the subject experienced cold-like symptoms. On 25-MAR-2021, the subject experienced cough. On 25-MAR-2021, the subject experienced right arm pain at the injection site. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 2021, had not recovered from right arm pain at the injection site, cold-like symptoms, cough, fatigue, and headaches, and the outcome of left foot numbness/ numbness up to the left knee was not reported. This report was non-serious.
63 2021-05-01 weakness Fatigue and malaise within 3 hours; chills, nausea and vomiting after 11 hours; headache, muscle ach... Read more
Fatigue and malaise within 3 hours; chills, nausea and vomiting after 11 hours; headache, muscle aches, weakness and nausea/vomiting for 24 hours after the vaccine.
63 2021-05-01 tingling Itching that was like pinpricks all over the body, including the ankle, face, legs, and nose in part... Read more
Itching that was like pinpricks all over the body, including the ankle, face, legs, and nose in particular. (No itching at the injection site.) Developed a rash on face. These all developed within 15 minutes of receiving the vaccine. Took a benadryl to be safe shortly afterwards. Itching lasted for approximately 2 days. The rash is still about the same. There was also swelling at the injection site, plus a rash that developed at the site about a day later. Other symptoms, such as fatigue, tiredness, and achiness, seem to be more typical outcomes. Also developed a swollen lymph node under the arm that received an injection. This occurred two days afterwards.
63 2021-05-06 involuntary muscle movements The first symptom was the swollen lymph nodes in neck - that lasted a day and a half. About a week a... Read more
The first symptom was the swollen lymph nodes in neck - that lasted a day and a half. About a week ago, same thing - swollen lymph nodes in my neck (or throat area) - that lasted about a day and a half also. Two and 1/2 weeks later, when I developed the swelling and pain in my paratoid gland in my left jaw. Severe swelling - could barely open my mouth. So I saw DR, on the 19th of March. She prescribed a Z-pak antibiotic and the swelling took about a good week to two weeks and maybe a little longer for the swelling and everything to go away. I was on antibiotic for seven days. Since then I have had no other problems.
63 2021-05-06 seizure seizure, 3/25/21
63 2021-05-09 pain in extremity NAUSEA; FEVER; SLIGHT ARM PAIN; This spontaneous report received from a patient concerned a 63 year ... Read more
NAUSEA; FEVER; SLIGHT ARM PAIN; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180890 expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 99.8. On 02-MAY-2021, the subject experienced slight arm pain. On 04-MAY-2021, the subject experienced nausea. On 04-MAY-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight arm pain on 02-MAY-2021, and had not recovered from nausea, and fever. This report was non-serious.
63 2021-05-13 unresponsive to stimuli Patient was vaccinated on 4/10/2021, with the Johnson & Johnson (Janssen) Covid-19 Vaccine. On 4/14/... Read more
Patient was vaccinated on 4/10/2021, with the Johnson & Johnson (Janssen) Covid-19 Vaccine. On 4/14/2021, patient had a stoke and collapsed, falling on her head & face at approiximately 3pm. No signs/symptoms prior to stroke & collapsing. Patient became hospitalized with internal bleeding in her brain and is still unresponsive. ‘Unresponsive' in this case is defined as but not limited to: unable to be mobile / stationary in a reclined bed postion since the incident / no movement of upper & lower extremities / minimal reactionary response in eyes / unable to ingest food by mouth
63 2021-05-15 pain in extremity that night, work from sleep with rapid heart beat, headache, sweating, nausea, took aspirin, drank m... Read more
that night, work from sleep with rapid heart beat, headache, sweating, nausea, took aspirin, drank more water, work just feeling off, slight headache and nausea, and left arm pain, concern of blood clots.
63 2021-05-16 pain in extremity Pain in right arm and shoulder. Sometimes it radiates down arm into the elbow and wrist. It is not... Read more
Pain in right arm and shoulder. Sometimes it radiates down arm into the elbow and wrist. It is not consistent. Sometimes it is very light, and other times it is very severe. I have also had a great deal of weakness in the right arm since the vaccination.
63 2021-05-16 sciatica after her vaccination on 4/2/21, she was tired on 4/5/21. on 4/11, she was achy, had HA, sens to lig... Read more
after her vaccination on 4/2/21, she was tired on 4/5/21. on 4/11, she was achy, had HA, sens to light, stomach, backache, nauseous, bilat sciatic pain, temp up to 102, fatigued, oxygen sat 92%. she had visual hallucinations. she went to ER on 4/15/21.
63 2021-05-17 pain in extremity STUFFED NOSE; FELT TO LAY DOWN AND SLEEP; ARM SORENESS; HEADACHE; FELT VERY FATIGUED; This spontaneo... Read more
STUFFED NOSE; FELT TO LAY DOWN AND SLEEP; ARM SORENESS; HEADACHE; FELT VERY FATIGUED; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, tachycardia issues, gi issues, esophageal issues, post nasal drip issues, nausea, gerd, acid reflux, and seasonal allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced stuffed nose. On 10-MAY-2021, the subject experienced felt to lay down and sleep. On 10-MAY-2021, the subject experienced arm soreness. On 10-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced felt very fatigued. Laboratory data (dates unspecified) included: Cardiac monitoring (NR: not provided) Abnormal, ECG (NR: not provided) Clear-Normal, and Vaginal biopsy (NR: not provided) Clear. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from arm soreness, headache, felt very fatigued, and stuffed nose, and the outcome of felt to lay down and sleep was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
63 2021-05-18 weakness SHORTNESS OF BREATH (WORSE UPON EXERTION); ELEVATED HEART RATE; DIZZINESS; CHEST PAIN; WEAKNESS; FEV... Read more
SHORTNESS OF BREATH (WORSE UPON EXERTION); ELEVATED HEART RATE; DIZZINESS; CHEST PAIN; WEAKNESS; FEVER; MUSCLE ACHES; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, allergy to plavix, and compazine allergy. The patient was previously treated with for drug used for unknown indication; and experienced drug allergy when treated with amlodipine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced shortness of breath (worse upon exertion). On 13-MAY-2021, the subject experienced elevated heart rate. On 13-MAY-2021, the subject experienced dizziness. On 13-MAY-2021, the subject experienced chest pain. On 13-MAY-2021, the subject experienced weakness. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced muscle aches. On 13-MAY-2021, the subject experienced headache. On 13-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, muscle aches, and headache, and had not recovered from shortness of breath (worse upon exertion), elevated heart rate, dizziness, weakness, fatigue, and chest pain. This report was non-serious.
63 2021-05-18 pain in extremity I experienced usual side effects, fever and chills but the entire reason is that I have swelling and... Read more
I experienced usual side effects, fever and chills but the entire reason is that I have swelling and edema in both feet and ankles enough so to concern doctors. I went to clinic on 03-26-2021 for evaluation. They put me on 3 day steroids. I went back to First med which they put me on a 6 day course of medication of steroids. I then went to my podiatrist, of my right ankle, I was scanned for blood clots but no blood clots were found. My exams only identify swelling and edema. I can only take NSAID'S. I have to get up wait a few hours to move. My ankle swelling and edema nerve decreases and my feet hurt so bad when I apply pressure. I had an MRI done as well and I am very upset that they cant find why I can not walk without pain and swelling. My doctors at this point do not what to do for me and I would like some answers. To this day, I am still having swelling and edema to both of my feet and ankles.
63 2021-05-20 pain in extremity Hemoptysis, flank pain, bilateral leg pain, headache. Found to have thrombocytopenia of 44, extensiv... Read more
Hemoptysis, flank pain, bilateral leg pain, headache. Found to have thrombocytopenia of 44, extensive bilateral PEs, and nonocclusive aortic thrombus. Treated with IVIG x 2 days and argatroban. Course is ongoing at ~48 hours since presentation.
63 2021-05-22 speech disorder, muscle twitching The injection did hurt quite a bit more than other injections I have had in the past but it began to... Read more
The injection did hurt quite a bit more than other injections I have had in the past but it began to feel better and I sat in a chair and was on my phone to send a message, spoke to a stranger who was looking for where to go, and was ok until the feeling of fainting began 10 minutes after the shot. I put my head between my knees but it did not help so I called for help and eventually was helped onto the floor to lie down which began to help. I had vision trouble and hearing trouble and could not speak. I was told my neck became bright red as my face grew white and my hands twitched and my eyes rolled around. I found out later that I had also peed my pants. I have fainted only once before in 1989, and found this reaction pretty frightening although I do not believe it happened as a result of anxiety or fear, the adverse effect itself was frightening and unexpected- not listed on any paperwork I received and was not aware it could occur.
63 2021-05-25 bell's palsy, burning sensation, numbness, tingling 5 days after injection developed right sided face and lip numbness, tingling, burning, swelling. Dia... Read more
5 days after injection developed right sided face and lip numbness, tingling, burning, swelling. Diagnosis: Bells Palsy
63 2021-05-25 pain in extremity ITCH IN LEGS AND ARM; LITTLE POLKA DOTS /FLUID-FILLED BLISTERS (RASH ON ARMS AND LEGS AND LITTLE BIT... Read more
ITCH IN LEGS AND ARM; LITTLE POLKA DOTS /FLUID-FILLED BLISTERS (RASH ON ARMS AND LEGS AND LITTLE BIT ON STOMACH); SHARP PAINS FROM SHOULDER TO THE ELBOW/ SORE ARM; SHARP PAIN DOWN TO WRIST/JOINT PAIN; FLUID LEAKING; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included supraventricular tachycardia, low blood pressure, and osteoporosis, and other pre-existing medical conditions included the patient had taken a natural hormone medication from a compounding pharmacy and also osteonutrients and unspecified medication for osteoporosis. The patient experienced drug allergy when treated with cyclobenzaprine hydrochloride, and tetanus vaccine for drug used for unknown indication, drug allergy when treated with clarithromycin, diazepam, and hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 08:55 for prophylactic vaccination. Concomitant medications included atenolol for supraventricular tachycardia. On 13-MAY-2021, the subject experienced fluid leaking. On 13-MAY-2021, the subject experienced sharp pains from shoulder to the elbow/ sore arm. On 13-MAY-2021, the subject experienced sharp pain down to wrist/joint pain. On 14-MAY-2021, the subject experienced itch in legs and arm. On 14-MAY-2021, the subject experienced little polka dots /fluid-filled blisters (rash on arms and legs and little bit on stomach). Treatment medications (dates unspecified) included: calamine/glycerol/zinc oxide, ibuprofen, charcoal, activated, triamcinolone acetonide, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from sharp pain down to wrist/joint pain on 14-MAY-2021, had not recovered from little polka dots /fluid-filled blisters (rash on arms and legs and little bit on stomach), and itch in legs and arm, and the outcome of fluid leaking and sharp pains from shoulder to the elbow/ sore arm was not reported. This report was non-serious.
63 2021-05-26 discomfort 25 March 2021 – Woke up with severe pain, left chest, breathing was fine, however, it was very pain... Read more
25 March 2021 – Woke up with severe pain, left chest, breathing was fine, however, it was very painful to breath, laugh, cough or sneeze and walking. It was painful to roll out of bed each morning at least for a week or so. I live with the pain/discomfort for a few days, thinking it would get better. 30 March 2021 – I called my PCP, who had no appointments, I ask the appointment person to have someone from her office call me. They call back later in the day and said that the dr was fully booked and ask if I was willing to see someone else, answer was yes. see continuation page
63 2021-05-26 pain in extremity, burning sensation As the lady jabbed me and started putting the vaccine in my arm, it started burning. It hurt so bad ... Read more
As the lady jabbed me and started putting the vaccine in my arm, it started burning. It hurt so bad that I wanted to scream. I felt lightheaded and needed to sit for awhile after the shot. The next night I started getting pain in my right arm and I couldn't move it. My nerve endings in my arm, shoulder, and clavicle felt like they were on fire. The lymph nodes under my right arm and neck were swollen. I had three swollen lymph nodes in my neck, but one went down, and I still have two swollen nodes in my neck. My quality of life has suffered because the pain in my arm is so bad.
63 2021-05-26 pain in extremity pain in left arm, after 10 days.....bad cough , head cold, touch of pnuemomia.
63 2021-05-27 weakness Extreme high fever Chills Headache Muscle pain Weakness Short of breath Chest pain Rapid heart rate ... Read more
Extreme high fever Chills Headache Muscle pain Weakness Short of breath Chest pain Rapid heart rate Fever and chills went away after 4 days, all other symptoms continue I have had pulmonary function testing, and more appointments scheduled
63 2021-06-01 pain in extremity I had a case of shingles. Started with rear upper thigh leg pain. It turned into a right side rash a... Read more
I had a case of shingles. Started with rear upper thigh leg pain. It turned into a right side rash and moved all the way up to my rear - mainly the back side of my leg. It was very severe and painful. The doctor gave me Valtrex (Valacyclovir tablets), Tylenol, and Methylprednisolone. I had some relief after a week, but the rash started to scab up.
63 2021-06-07 muscle spasms, numbness On the 21st, my rib muscles on left side - spasms - hard to breathe or take a deep breath. About mo... Read more
On the 21st, my rib muscles on left side - spasms - hard to breathe or take a deep breath. About month ago left foot and left hand - was start to numbness - moving up my calf a little bit - doctor thought it was a nerve impeachment. About two weeks ago, Breathing with rib muscles are starting to be better - it's not gone however. The last couple of days, I have had a little numbness in my right foot and then it went away.
63 2021-06-09 numbness, tingling, pain in extremity, nerve injury pt says she started having pain all over her body. The pain from her knees down to her feet was hor... Read more
pt says she started having pain all over her body. The pain from her knees down to her feet was horrible. The left arm hurts and has tingling numb feeling in the hand. She gets episodes of being light headed and SOB. She gets sharp pains in her head like something is pinching her on the inside of the brain and is a very strange feeling. She went to see her PCP about 10 days after taking vaccine and was referred to a Neurologist Dr. She was told it looked like nerve inflammation and was prescribed Neurontin. The medicine helps but has side effects and makes her feel bad. She has a FU appt next week.
63 2021-06-09 pain in extremity FELT WOBBLY; MILDLY SORE ARM; TEARY FOR NO REASON OR SOBBING (OVER EVERYTHING SEVERAL TIMES A DAY); ... Read more
FELT WOBBLY; MILDLY SORE ARM; TEARY FOR NO REASON OR SOBBING (OVER EVERYTHING SEVERAL TIMES A DAY); EVERYTHING HURT HER FEELING; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included doesn't metabolize alcohol, and menopause, and other pre-existing medical conditions included patient had nothing wrong and had no ongoing medical issues, patient was not on medication of any kind and had not taken any medication after shot. the patient had pms (premenstrual syndrome) (wanted to cry over everything, no anger though). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, and expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced teary for no reason or sobbing (over everything several times a day). On MAY-2021, the subject experienced everything hurt her feeling. On 09-MAY-2021, the subject experienced felt wobbly. On 09-MAY-2021, the subject experienced mildly sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teary for no reason or sobbing (over everything several times a day), everything hurt her feeling, and mildly sore arm on MAY-2021, and had not recovered from felt wobbly. This report was non-serious.
63 2021-06-16 breast pain Began my yearly physical two days after the vaccine, as did my husband. Both of our urine tests show... Read more
Began my yearly physical two days after the vaccine, as did my husband. Both of our urine tests showed blood in our urine. Had a second urine test a month later. Still had blood in urine. Also had 3 weeks of diarrhea. That was followed by a vaginal yeast infection. Given a prescription to clear that up. Then my breasts became swollen and painful. It has been ten weeks since the vaccination. Saw a urologist this week there is still blood in my urine. The amount of blood has decreased, but still showing up.
63 2021-06-16 burning sensation, pain in extremity Patient complained of burning sensation immediately after receiving vaccine and progressively worsen... Read more
Patient complained of burning sensation immediately after receiving vaccine and progressively worsening arm pain over the course of a few day after vaccine administration. Patient states arm pain did not resolve and was seen at provider's office 6/17/21 stating she has decreased range of motion to left arm and continues with left deltoid pain. X-ray of left shoulder and humerus were ordered along with physical therapy.
63 2021-06-20 weakness I had a really severe sore throat; I lost my voice for awhile. Water on my ears and 101 degree tempe... Read more
I had a really severe sore throat; I lost my voice for awhile. Water on my ears and 101 degree temperature. Runny nose really bad. There was drainage down my throat from runny nose. Feeling really weak and tired. Really deep down in my lungs cough. I was sick for about five days and then went to Urgent Care; Cough medicine and Z-Pak Antibiotic that helped with all except the water in my ears. That hasn't gone away yet so my hearing is a little off. The cough lasted for about two and 1/2 weeks but is gone now. I cough every once in a while, but not bad. I may go back to the Urgent care for my ears.
63 2021-06-21 tremor Tremors in left arm and left leg
63 2021-06-30 pain in extremity After the vaccine, I was just tired and a little soreness in arm but not much. Shingles - painful so... Read more
After the vaccine, I was just tired and a little soreness in arm but not much. Shingles - painful soreness in my upper buttocks/hip area and I felt a bit of bruising when I did my walk - when I looked at it - it looked like a belt and was red. It had a mild case of shingles because I had a Shingles vaccine in May 6th. I took a phone of the shingles and sent it to my doctor and she prescribed an anti-viral medication and I took that through yesterday. That helped to resolve it. It's just now a kind of a dry patchy area.
63 2021-07-01 facial pain The night of the vaccine I got hives on my chest which lasted for an hour. The first week after the ... Read more
The night of the vaccine I got hives on my chest which lasted for an hour. The first week after the vaccine I had severe flu like symptoms of fever, nausea and sweats for six days. The next week on 04/15/2021 I started to get pain over my left eyebrow and my Diverticulitis was flared up. My doctor sent me to get the headache checked out because it was very painful. The headaches were there all day every day and localized to the left side over my eyebrow. Migraine medicine made it worse Sumatriptan. The pain persisted but I was checked up for Glaucoma. My Neurologist advised that I take Indomethacin and it worked to relieve the pain. Regular pain killers did not work. It slowly improved over the course of two months. It had been twelve weeks and I am still getting headaches intermittently, It is more like a twinge.
63 2021-07-04 weakness Shortness of breath, weakness, heart palpitations. and got diagnosed with both bronchitis and pneumo... Read more
Shortness of breath, weakness, heart palpitations. and got diagnosed with both bronchitis and pneumonia.
63 2021-07-05 tremor, feeling cold, pain in extremity At 04:00 pm, excessive fatigue. I was taking my mom shopping and I had to stop and take her home. Ju... Read more
At 04:00 pm, excessive fatigue. I was taking my mom shopping and I had to stop and take her home. Just excessive fatigue. 3/26/ 21- I woke up at 01:00 am with chills; freezing and infrequent tremors. I had a bad headache. Body aches. 04:00 am started feeling nausea. I contacted Dr to see what I could take. Got a reply email that recommended not to take anything. I toughed it out and I was in bed all day. I finally ate at 05:00 pm that day for the first time. The nausea and chills subsided with the mild food. But headache and achy body persisted. On 3/27, mild headache and mild body aches - I was a 2 out of 10 for pain. It continued to get better. I have joint pain in the winter when it is cold but I don't have any of that when it's warm. But I'm having joint point this summer. Which is weird and not usual. My joints have never hurt in summer time and spring before but have been this year. My left shoulder is frozen out of the blue at the injection site. It hurts. Have been having foot pain. Shooting pain in my right heal. Communications via email to Dr and Dr said to do heat and ice and sent me exercises to do with feet and shoulder. The shoulder still hurts but it is slowly getting better. I have been seeing Naturopath for hormone/menopause and I have been taking the hormonal supplements a month before the shot.
63 2021-07-08 numbness Instant right fingertips numbness, Breast itch and have for days, the numbness in fingertips have n... Read more
Instant right fingertips numbness, Breast itch and have for days, the numbness in fingertips have not gone away. Shortness of breathe on and off. Headache the evening and next day after the shot.
63 2021-07-08 pain in extremity Right after the vaccine - Really bad sore arm for at least a week. I did have chills and aches for m... Read more
Right after the vaccine - Really bad sore arm for at least a week. I did have chills and aches for maybe a day. My usual joint pain that I experience wasn't worse that usual but I had just gotten cortisone shots a month earlier (March) so it was possible that it was keeping it all under control. But now I've been experiencing pain in joints. My thumb joints are in a lot of pain, very difficult to do almost anything; my lower back is really inflamed - the bones there. Other joints - knees and other joints hurt too but mostly those joints. Had chiropractic care - sometimes that increase inflammation because I'm moving the joints and but also have gotten 7 laser treatments on those joints - which has helped. Another number to call regarding my joint pain history medical records- haven't seen him since March, though -Doctor - who did - - he's not listed as my doctor but he did the cortisone shot and was my doctor before.
63 2021-07-09 unresponsive to stimuli Pt was moved from vaccine area to observation area to a chair pt then passed out onto a table next t... Read more
Pt was moved from vaccine area to observation area to a chair pt then passed out onto a table next to hair eyes wide open non responsive with faint to no pulse. 911 was then called and a dose of epipen given which brought the patient out of the unresponsive state within 30 seconds. Pt was then helped to the floor and observed until ems arrived.
63 2021-07-10 pain in extremity, numbness About 5 days after the shot, I was still having a lot of fatigue, but I developed severe headaches, ... Read more
About 5 days after the shot, I was still having a lot of fatigue, but I developed severe headaches, like someone was sticking a knife in my head, and I was having bouts of light headedness. I am a person who never has headaches. Because the issue of the blood clots came about with the J&J, I ended up, because of the severe headeaches had to have a brain MRI to rule out the blood clots. I did not have any. But the headaches were very much a problem and the light headedness. I had to leave area for the summer, and now came to another area. I still was not feeling right. The bad headaches subsided, but I was till getting the lightheadedness with a slight headache after almost every day. II also had a full blood panel done on April 8. It is showing my thyroid is low and now have to be on Thyroid medication. I just had full blood work done in March, and all my blood work was normal. I also have noticed that my arthritis in my hands is exacerbated. And sometimes my feet go numb when I am riding my horse. And in the morning, my arms and legs ache. My BP was a little elevated as well. I never have had high blood pressure. I am 63 years old and have always had great health. Since I had the covid shot, I have had nothing but problems. If I had to do it over again, I WOULD NOT have gotten the shot. I only got it because my daughter was having a baby and insisted even though I had the virus back in October.
63 2021-07-11 breast pain, pain in extremity Rushed to emergency room with severe, severe pain left shoulder, arm, hand, underarm breast, upper b... Read more
Rushed to emergency room with severe, severe pain left shoulder, arm, hand, underarm breast, upper back and midback (left side). Given morphine and nausea and sent home. Still in pain. Rushed back to emergency room exactly a week later with same symptoms plus blisters and rash (still left side). Treated for symptoms of shingles, but no "classic" signs of shingles. Saw primary care doctor on 06/02/2021. Continued the treatment for shingles. Extremely limited function in left hand (holding, etc.) Future doctor visits schedule for August.
63 2021-07-12 muscle spasms, numbness, tingling Numbness , Tingling in my feet, severe leg cramps and now i can't walk came to the ER on June 22 20... Read more
Numbness , Tingling in my feet, severe leg cramps and now i can't walk came to the ER on June 22 2021 still here in rehab July 13th 2021
63 2021-07-12 seizure like phenomena, tremor, weakness, slurring It began with being light-headed and difficulty walking on March 25th. On April 14 I had my first "s... Read more
It began with being light-headed and difficulty walking on March 25th. On April 14 I had my first "seizure like" event as I was going to teach school. I had Upper arm tremors and difficulty speaking and walking. Sent by ambulance to the emergency room. Released later that day and given meds for UTI which was later deemed a misdiagnosis by Dr. Didn't go to work as I continued to have difficulty walking and had headaches and overall weakness. Saw Dr. on April 20th. Had to use wheelchair to attend the office visit and was given blood tests to see what was causing my condition. Had high blood pressure. She also advised me to see a neurologist and heart doctor. ON April 20th had to go back to ER as I had the smae seizure like event!On April 22nd I visited Dr. office (heart doctor). Blood pressure was off on this day as well and I stayed at clinic until it was better. Was given a heart monitor to wear for 24 hours. Heart was fine after wearing the monitor. Visited Neurologist and was given EEG and CT CTA tests. All came back fine.
63 2021-07-14 weakness Continued pain in upper left arm where given the shot. Never had pain there before until given the ... Read more
Continued pain in upper left arm where given the shot. Never had pain there before until given the shot. Pain sometimes wakes me up at night. No pain in right arm. Is difficult to get dressed in the morning and loss of strength in the upper arm. Pain started day after the shot in upper arm and has not gone away. Is tender to the touch at the location the shot was given in the arm.
63 2021-07-18 tingling brain fog vision problems, extreme exhaustion weight gain all scar tissue from surgerys is sw... Read more
brain fog vision problems, extreme exhaustion weight gain all scar tissue from surgerys is swollen and painful blown up and very visible, ( face is distorted) tingling in hands and feet
63 2021-07-25 pain in extremity, muscle spasms severe leg and foot cramps/spasms. every night and sometimes during the day time. toes point downwar... Read more
severe leg and foot cramps/spasms. every night and sometimes during the day time. toes point downwards like a ballerina's foot, calf muscles get hard and very painful. sometimes my foot shakes when this happens
63 2021-07-28 burning sensation Every few weeks since the vaccine I experience a sharp stabbing pain at the vaccine site. Another s... Read more
Every few weeks since the vaccine I experience a sharp stabbing pain at the vaccine site. Another symptom that that began slowly (every week or so) until now when it is several times daily-feeling a prick and then a burning sensation on one of my toes or fingers like a fire ant is biting me. The pain lasts for hours-no red marks. I have also experienced the same sensation on my arms, over ribs, abdomen and legs. I have not spoken to my Dr. about this, but will if the frequency keeps up.
64 2021-03-06 flushing Face, neck, and ears became flushed within 5 minutes of the injection. Remained red for approximatel... Read more
Face, neck, and ears became flushed within 5 minutes of the injection. Remained red for approximately one hour.
64 2021-03-07 involuntary muscle movements, unresponsive to stimuli Patient seemed to pass out. Reported fear of needles. Happened about 13 minutes after vaccine was ad... Read more
Patient seemed to pass out. Reported fear of needles. Happened about 13 minutes after vaccine was administered. She wasn't responsive to voice for short time period with a blank stare. Once she snapped out of it, she jerked and then we tried to make her more comfortable. EMS was contacted to verify patient was okay. Patient did not want to go to hospital or ER.
64 2021-03-07 tremor Janssen COVID-19 Vaccine EUA Uncontrollable Shakes, fever spiking between 100 and 104, throwing up, ... Read more
Janssen COVID-19 Vaccine EUA Uncontrollable Shakes, fever spiking between 100 and 104, throwing up, pounding headache, aches throughout body
64 2021-03-09 weakness Bad headache, nausea - threw up numerous times until there was no more to throw up. These condition... Read more
Bad headache, nausea - threw up numerous times until there was no more to throw up. These conditions lasted for about 30 hours, followed by body aches and weakness. Now feeling mostly better two days after receiving vaccine.
64 2021-03-09 burning sensation, flushing Face flushing within 1/2 hour that then subsided within another 1/2 hour. 6 1/2 hours after inocula... Read more
Face flushing within 1/2 hour that then subsided within another 1/2 hour. 6 1/2 hours after inoculation, at 7pm, I began to feel unwell. I felt a burning all over my body (especially my back), and body aches, and began a fever which grew from 97.3 (my normal) to a high of 100.1 (+2.8 degrees) within 2.5 more hours (by 9:30pm). Very bad chills and fever. By 9:30 took 1 500mg Tylenol. Little sleep that night. Felt very unwell next day (3/9) including headache. At noon I could get up and get some food. By 1pm fever subsided completely, but temporarily. Fever came back by 4pm, but only to 98.6 (+1.3 above normal). Took another 500mg Tylenol. Night 2 slept well. Woke up 3/10 no fever, headache gone, but balance still peculiar. I noticed the first night that my sense of balance was off.
64 2021-03-10 numbness, tingling 64 y.o. female who is consulted for possible stroke. Patient reports that she awoke this morning (3... Read more
64 y.o. female who is consulted for possible stroke. Patient reports that she awoke this morning (3/10/2021) at about 4:30 PM with severe spinning dizziness. She reports associated nausea, diaphoresis, blurred vision and bilateral hand numbness and tingling. She denies speech or language problems or weakness. She reports she got a COVID vaccine (Johnson & Johnson) Sunday 93/7/2021) and felt a little "woozy" Monday (3/8/2021).
64 2021-03-11 migraine Sevier migraine, chills and fever
64 2021-03-13 tremor Beginning around 3 pm on 3/10/2021 I experienced chills. The chills worsened, accompanied by bodily... Read more
Beginning around 3 pm on 3/10/2021 I experienced chills. The chills worsened, accompanied by bodily shaking. Around 6 pm I experienced body aches. By 9 pm my temperature was 100.4 and I had a mild headache. By 10 pm my temperature was 100.6. At that time I took two 200 mg ibuprofen. At 4:00 am on 3/11/2021 I began vomiting and felt like I would pass out. Vomiting continued until approximately 9:00 am on 3/11/2021. As the day progressed on 3/11/2021 I began to feel somewhat better. Since 3/12/2021 I have felt sporadic, brief periods of nausea and light-headedness. This continues at this time, 3/14/2021.
64 2021-03-14 feeling hot Patient received J&J vaccine at 15:01, approximately 10 min later patient reported she felt her tong... Read more
Patient received J&J vaccine at 15:01, approximately 10 min later patient reported she felt her tongue was swelling and her face was getting red and hot. Following the reaction protocol patient received 0.5mg of epinephrine IM at 15:26 and was moved to a stretcher. EMS was called, again per protocol. EMS recommended patient be transported to hospital but patient refused. Patient ambulated out of clinic independently and drove home.
64 2021-03-15 breast pain Severe headache, overwhelming fatigue, 102.7 temp, massive body ache, left armpit and breast extreme... Read more
Severe headache, overwhelming fatigue, 102.7 temp, massive body ache, left armpit and breast extremely sore
64 2021-03-15 tingling, feeling hot Within 12 hours I became to have severe muscle aches and joint aches. All my joint felt hot, it was ... Read more
Within 12 hours I became to have severe muscle aches and joint aches. All my joint felt hot, it was bad enough I wasn't able to sleep. I took Ibuprofen to help sleep. I slept most of Friday I has extreme fatigue. On Saturday I has muscle weakness and tingly in my hands, the muscle aches have gone away. I couldn't knit ot fine motor skills, It bothered me. I woke up on Sunday where I had extremes muscle weakness in both my legs. I called my PCP, they were surprised by how the reaction was delayed. They wanted me to get a test for the strength in my legs and sent me to the ER. I wen to the Er they tested for stroke, blood work, scans, they were worried about Guillain Barre Syndrome. I stayed there about 5 hours. Yesterday afternoon the tingly went away from my hands but my legs are still kinda goofy. The muscle in my forearm and thigh feel like my muscle are really sore, like they have been tense
64 2021-03-15 tremor 11:00 am - very mild rash on face - 2 spots started at 4:15 pm - peeked at 5:45 pm - temperature 10... Read more
11:00 am - very mild rash on face - 2 spots started at 4:15 pm - peeked at 5:45 pm - temperature 100 degrees, sever chills, violent shaking, bad body aches especially back area, headache. Took Advil which reduced violent shaking, chills and body aches by 6:30 pm. Remained fatigued rest of evening.
64 2021-03-17 burning sensation My blood sugar went to 364 and stayed there all day and then that night it was 267 and then it was t... Read more
My blood sugar went to 364 and stayed there all day and then that night it was 267 and then it was the next morning 202 and then it went to normal in the low 100s. Hives in the crook of my right arm. Burning, itchy little red bumps. I couldn't swallow but I think that was from the high blood sugar as my mouth was very dry. I felt like I had a really bad cold, my head felt foggy.
64 2021-03-19 numbness Site: Pain at Injection Site-Mild, Systemic: patient stated \"palpitations\"-Mild, Systemic: Numbnes... Read more
Site: Pain at Injection Site-Mild, Systemic: patient stated \"palpitations\"-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient received Janssen covid vaccine 3/12/21 at 5:04pm to her left arm. Due to patient's response on the screening questions, patient was to be observed for 30 min. At 5:30pm patient complained of numbness to arms and face. At 5:34pm patient state she had palpitations. Rph on duty advised husband to take her to ER asap. For next 3days, rph on duty attempted to call the patient multiple times throughout the day but the phone would go straight to busy signal.
64 2021-03-20 weakness fever, dizziness, nausea, weakness, swelling of face, break out in hives, low blood pressure
64 2021-03-21 weakness Bad headache that Tylenol was able to handle, drained feeling the next day, arm sensitive at site. F... Read more
Bad headache that Tylenol was able to handle, drained feeling the next day, arm sensitive at site. Fine later next day and into the next no problems.
64 2021-03-21 weakness Chills, headache, weakness, nausea, fatigue. Moderate the first night, then waning for 4 days.
64 2021-03-23 tremor Extreme fatigue and muscle ache throughout body, fever, chills and shaking, intense headache. Vaccin... Read more
Extreme fatigue and muscle ache throughout body, fever, chills and shaking, intense headache. Vaccine was administered at 9:30 am. Symptoms began around 3:30 pm and lasted until approximately 5:00 am the next day.
64 2021-03-26 weakness deep sharp pain in the muscle where the shot was administered. along with slight fever and low energ... Read more
deep sharp pain in the muscle where the shot was administered. along with slight fever and low energy.
64 2021-03-26 pain in extremity I have severe body aches including the bottom of my fee.
64 2021-03-27 tremor 9 hours after getting the J&J vaccine I had bad chills. My body was shaking and my teeth were chatte... Read more
9 hours after getting the J&J vaccine I had bad chills. My body was shaking and my teeth were chattering despite being bundled under 3 blankets. It lasted about10/15 minutes followed by a headache and body aches. The headache and body aches continued the next day and was treated with Tylenol.
64 2021-03-31 feeling hot Bad headache, muscle pain over entire body, chills ,then hot, 101.7 fever. I just slept a lot ,drank... Read more
Bad headache, muscle pain over entire body, chills ,then hot, 101.7 fever. I just slept a lot ,drank lots of water, everything but the muscle ache is gone
64 2021-03-31 tingling, feeling hot Rosacea flare up within 10 minutes of injection. Face bright strawberry red. Entire body became hot ... Read more
Rosacea flare up within 10 minutes of injection. Face bright strawberry red. Entire body became hot and had to fan myself (not a hot flash) Approximately 45 minutes later left ear started tingling and then pain followed and only in left ear. An hour after the shot ( and back home) started feeling tingling in lips and face. Face swelled up and smoothed out wrinkles. Lasted about 2 hours and then subsided. Also metallic taste in mouth during swelling of the face. Metallic taste lasted as long as the face swelling which was about 2 hours. Loose stools and tummy upset which is still going on.
64 2021-04-03 muscle spasms Severe chills, chattering teeth, spasms, aching neck, some soreness at injection site
64 2021-04-04 burning sensation Lymph nodes under both arms and in breasts achy, burning and sore for a month
64 2021-04-05 hot flush, breast pain 30 minutes after receiving the vaccine- -- hot flashes that lasted 8 hours. Right away after receivi... Read more
30 minutes after receiving the vaccine- -- hot flashes that lasted 8 hours. Right away after receiving the vaccine-- stiff neck on the left side which after a night's sleep, moved to my right side of neck. No big deal. Tired & 'drunk' after the vaccine which lasted until mid-afternoon the next day. No big deal. The worst of all happened at 3 1/2 days, a rash started in the evening, went to bed, woke up the next day with rash almost everywhere. Red, swollen, & itching like crazy. The next day- Sunday, along with Monday & Tues. was horrid. I am covered from my scalp to the tops of my feet, my crotch hurts, as do my breasts. Used Benadryl cream, aloe vera to no avail.
64 2021-04-05 cold extremities day after vaccine was extremely tired and both hands were frozen cold, following day woke up with cl... Read more
day after vaccine was extremely tired and both hands were frozen cold, following day woke up with clogged right ear and I had vaccine shot in right arm. by end of day, I was feeling much better and ear was unclogged
64 2021-04-06 feeling cold FEELING VERY COLD; ACHES AND PAINS ARE ALMOST LIKE SHE GOT HIT BY A TRAIN; CHILLS; INJECTION SITE BU... Read more
FEELING VERY COLD; ACHES AND PAINS ARE ALMOST LIKE SHE GOT HIT BY A TRAIN; CHILLS; INJECTION SITE BURNING; TIRED; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 at around noon on right arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced feeling very cold. On 25-MAR-2021, the subject experienced aches and pains are almost like she got hit by a train. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced injection site burning. On 25-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 96-97. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site burning on MAR-2021, had not recovered from tired, chills, and aches and pains are almost like she got hit by a train, and the outcome of feeling very cold was not reported. This report was non-serious.
64 2021-04-06 numbness Pt. received vaccine, no reports of soreness at site, no redness or irritation observed. Pt reports ... Read more
Pt. received vaccine, no reports of soreness at site, no redness or irritation observed. Pt reports numbness to R upper jaw, numbness doesn't radiate, no redness, no swelling. EMT on site, took VS. BP 125/87, p72, r22, temp 97.9, O2 Sat 100% on Room Air. Lungs CTA, PERRLA, grasps equal. No dizziness reported. EMT offered pt 25 mg tab of benedryl, refused at first then changed her mind and took 25 mg tab of benedryl. Pt immediately reports feeling better after swallowing tab. Pt was instructed to call 911 or go to closest ED if s/s increase or worsen. PT stated understanding instructions. Pt then stated she was fine and got up and ambulated safely with steady gate out of exit.
64 2021-04-06 migraine From March 8 th through March 18, I experienced very severe level 10, out of a scale from 1 to 10, m... Read more
From March 8 th through March 18, I experienced very severe level 10, out of a scale from 1 to 10, migraine pain and related usual symptoms day and night. I also experienced swelling of a 5 in area ,,soreness and redness ,around the injection site for the same amount of days. I normally suffer from chronic migraine.
64 2021-04-07 muscle spasms Pt received vaccine on 4/1/21. On Sunday, 4/4/21, pt started to have muscle cramps in thighs and all... Read more
Pt received vaccine on 4/1/21. On Sunday, 4/4/21, pt started to have muscle cramps in thighs and all down legs. Were so severe at times she couldn't walk. Muscle cramps subsided by 4/6/21 and pt noticed a knot on each inner thigh. Patient is concerned about the knots and if they may cause a blood clot.
64 2021-04-07 tremor Severe shaking chills, headache, fever, muscle aches that lasted several hours. Taking Advil helped ... Read more
Severe shaking chills, headache, fever, muscle aches that lasted several hours. Taking Advil helped reduce symptoms. These symptoms are typical of those who have taken the J&J vaccine and in fact, if you read the actual stories of the side effects of people who took this vaccine, shared on sites, these symptoms are closer to 100% present rather than the far lower and untrue percentage revealed by the CDC. These symptoms need to be better tracked and people should be forewarned how COMMON these side effects are; they are not rare!
64 2021-04-08 weakness, tremor, flushing Shot taken with no issues at 9:54am, April 4, 2021. At 5:30pm, same day, became immediate flush, diz... Read more
Shot taken with no issues at 9:54am, April 4, 2021. At 5:30pm, same day, became immediate flush, dizzy, barely made it to bathroom, violently vomiting all that was in my stomach. This was followed by severe chills, the shakes and a mild headache. Took (2) Tylenol at the time of the shot, drank many ounces of water all day but still had this issue. Took another (2) Tylenol after vomiting and more water. Went to bed at 8pm. Woke at midnight, 4/5/21, severe headache, now took (2) Advil and slept better until Mon. Morning, 4/5/2021. Experienced two sluggish, low energy days and still have no appetite. What the heck????
64 2021-04-08 feeling cold Cold, lethargic, achy from around 4-7 pm. Took Advil. About 9pm, MAJOR Chills, aches, fever over 10... Read more
Cold, lethargic, achy from around 4-7 pm. Took Advil. About 9pm, MAJOR Chills, aches, fever over 100 . Took Advil around 11, fell asleep around 2am. Following morning , temp back to normal, severe headache.
64 2021-04-09 numbness, tingling tingling on left side of face, numbness in left arm, blurry vision. Evaluated by EMS-Refusal to tran... Read more
tingling on left side of face, numbness in left arm, blurry vision. Evaluated by EMS-Refusal to transport.
64 2021-04-09 cold extremities, feeling cold 6-1/2 hours later: Symptoms came on quickly. Hands and feet felt frozen, chills, severe shoulder j... Read more
6-1/2 hours later: Symptoms came on quickly. Hands and feet felt frozen, chills, severe shoulder joint and muscle pain. Immediately had to lay down and took Advil/Tylenol. Could feel the movement of joint pain from shoulders to elbow, hips to knees. Headache. Couldn't navigate stairs safely. In bed or on the couch for 24 hours until 6pm Friday 4/9/2021. Three of us from the same company had the Janssen Vac within a day of each other and all 3 of us had the same adverse reaction. To me, that is not mild symptoms when it debilitated me and kept me from going to work. Most family members have had Pfizer with two shots and had NO side effects.
64 2021-04-10 weakness About an hour or so after the shot, continuing until now, only 36 hours later: A general sense of fe... Read more
About an hour or so after the shot, continuing until now, only 36 hours later: A general sense of feeling quite ill, headache, extreme fatigue, weakness and sleepiness, muscle aches over the past 36 hrs since the shot occurred. I have been in bed sleeping off and on feeling ill in waves. I feel less ill for hours at a time, during which I get up out of bed and function relatively normally. I felt completely fine (except for injection site achiness) until about an hour and a half after the shot, after which I went to sleep for several hours after which I felt better. The major symptom is the general feeling of 'being sick'.
64 2021-04-10 weakness Low Grade Fever (100.4), Burning Eyes, Headache, Body Aches, Lack of Energy
64 2021-04-10 pain in extremity I had no pain, swelling or redness in or around vaccine site. In the evening, my right hand and fin... Read more
I had no pain, swelling or redness in or around vaccine site. In the evening, my right hand and fingers began to swell, The next morning my hand and fingers were throbbing and I could not make a fist. I have iced it multiple times and the swelling is coming down today 4.11.21.
64 2021-04-10 tremor I wasn't sure how to indicate which dose I'm reporting on. It's my second dose of a vaccine but my ... Read more
I wasn't sure how to indicate which dose I'm reporting on. It's my second dose of a vaccine but my first of Johnson & Johnson. My first shot for Covid-19 was a Moderna shot, to which I had a bad reaction (immediate and prolonged lightheadedness reported already on this site). My doctor advised me that my second dose should be a Johnson & Johnson vaccine, as per information he had received from the CDC. So, 28 days after the first shot I had the Johnson & Johnson vaccine. I experienced the expected side effects of body aches, chills, headache--no big deal on day 2, but on day 3, I started some lightheadedness, as did my daughter who had the shot the same day. Her lightheaded subsided the next day, but mine continued into day 4 and got worse when it became accompanied by pressure in my head/ears, and it felt like I was talking in a tunnel with echoing. I couldn't function the rest of the day. Today, the head pressure is not there, but the lightheadedness and shakiness are still there. I hope I fully recover from these shots, but I don't have a lot of hope.
64 2021-04-11 pain in extremity soreness in arm, right bottom hurts, started cycle
64 2021-04-11 tremor, numbness Patient experienced numbness in peripheral extremities and lips, headache, hypertension, neck stiffn... Read more
Patient experienced numbness in peripheral extremities and lips, headache, hypertension, neck stiffness, tremor, and blurred vision
64 2021-04-12 weakness headache, weakness, blister-like issues in soft tissue of mouth and tongue
64 2021-04-12 feeling cold, pain in extremity, feeling of body temperature change Arm really hurt for about 15 min., then went away. Intense cold, couldn't get warm with multiple lay... Read more
Arm really hurt for about 15 min., then went away. Intense cold, couldn't get warm with multiple layers of clothes and blankets. Fever. Restless sleep ~ hot, then cold. Sunday am woke with a headache that lingered and felt like I was in a fog ~ dizzy if I turned my head quickly, and then really tired. About 7pm I felt fine.
64 2021-04-12 numbness Patient states that she had ear, cheek bone, some teeth and chin numbness. It started on the car rid... Read more
Patient states that she had ear, cheek bone, some teeth and chin numbness. It started on the car ride home after the 15 minute period of sitting by pharmacy for evaluation. Pt said it was about 25 minutes after vaccine. The numbness was only on the left side of her face. The vaccine was also in the left arm. She said her symptoms had completely resolved after 24 hours.
64 2021-04-12 pain in extremity Nine days after vaccination developed pain and swelling in lower right leg, ankle and foot. Red dis... Read more
Nine days after vaccination developed pain and swelling in lower right leg, ankle and foot. Red discoloration of lower leg and purple and blue discoloration on ankle/foot. Went to ER suspected blood clot. Ultrasound and blood work were done. NO blood clot was found.
64 2021-04-12 pain in extremity Right leg pain for 2days . Then left leg pain 4 days later.
64 2021-04-12 pain in extremity Vax received Saturday. Entire leg very sore on Sunday. Monday morning woke early with pain in the... Read more
Vax received Saturday. Entire leg very sore on Sunday. Monday morning woke early with pain in the knee that was replaced. I was unable to straighten leg when lying in bed. I managed to stand up and walk it off, but with pain as severe as in January when knee was replaced. Leg continued to be sore, then Monday night I didn't have the same issue w/bending, but I did wake early with horrible stabbing pains in knee. I treated with Tylenol, Alprozalan & Ice.
64 2021-04-12 pain in extremity Awakened earl y morning 12:00 am of April 9th with horrible pain in left calf of leg. Pain continue... Read more
Awakened earl y morning 12:00 am of April 9th with horrible pain in left calf of leg. Pain continued throughout the night, until I finally got up and just walked around house to try to get some relief then laid down and try elevating leg on pillows. The pain continued so got u p and walked around more and pain finally subsided enough to get some rest. Then felt like just had a bruise in that area of the leg for a day.
64 2021-04-12 pain in extremity Beginning the following morning after my vaccination, at approximately 8:30 am, I began having sever... Read more
Beginning the following morning after my vaccination, at approximately 8:30 am, I began having severe stabbing chest pains. Feeling as though I was being stabbed dead center of my chest and it came out my back. I had trouble breathing or felt like it hurt more when I tried to take a deep breath. This was very severe for about 2 hours then eased off and was off and on for about two days. My arm did not get sore until the third day after my vaccination and remains sore still. I?ve experienced a headache in severity ranging from a nuisance to temple throbbing since the day after vaccination. I have taken my naproxen for the chest pain and headache. I ran a temp of 99-100 occasionally but never for a long period of time. I?m still experiencing some chest pain occasionally but nothing as severe as the first two days.
64 2021-04-12 tingling, nerve pain, burning sensation 2 weeks post inoculation developed burning sensation/tingling /pain from armpit to thumb; some tingl... Read more
2 weeks post inoculation developed burning sensation/tingling /pain from armpit to thumb; some tingling in thumb - sensation more like nerve pain vs muscle pain. After two days gradually improved. Muscle strength not affected, but movement in most directions elicited sharp pain coursing down arm. Gradually improving to pain over the deltoid near injection site; as of 19 days since initial pain motility much improved but still periodically throbs and sensitive to pressure and certain movements. No treatment except restricting use of arm and time. 10 hrs post inoculation developed chills, myalgia and headache. Chills and myalgia resolved in a few hours; an aspirin the next day resolved the headache. This reaction was not unexpected. Did not have pain at injection site until 2 weeks post injection.
64 2021-04-12 tingling On Wednesday, March 24th approximately 4:00 PM I started having severe chest pain, shortness of brea... Read more
On Wednesday, March 24th approximately 4:00 PM I started having severe chest pain, shortness of breath and tingling in my face. After about 40 minutes of severe chest pains and shortness of breath and tingling in my face I took 2 81 mg baby aspirin called 911 was advised to take two more 81 mg baby aspirin. Transported to ER.
64 2021-04-13 muscle spasms LETHARGIC; HEAVINESS OF HEAD; CRAMPS IN LEGS; ACHEY; GENERALLY FELT LIKE A CRAP; DRY MOUTH; NAUSEOUS... Read more
LETHARGIC; HEAVINESS OF HEAD; CRAMPS IN LEGS; ACHEY; GENERALLY FELT LIKE A CRAP; DRY MOUTH; NAUSEOUS; HEADACHE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included heart defect. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered in Left Arm on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced heaviness of head. On 08-APR-2021, the subject experienced cramps in legs. On 08-APR-2021, the subject experienced achey. On 08-APR-2021, the subject experienced feeling bad. On 08-APR-2021, the subject experienced dry mouth. On 08-APR-2021, the subject experienced nauseous. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, nauseous, headache, heaviness of head, cramps in legs, achey, feeling bad, and dry mouth. This report was non-serious.
64 2021-04-13 pain in extremity, coordination abnormal, weakness, tremor, slow speech 4/8/21: "Six and a half hours after my J&J vaccine I had started shaking with severe chills. By 8 ho... Read more
4/8/21: "Six and a half hours after my J&J vaccine I had started shaking with severe chills. By 8 hours after my vaccine I had impaired coordination, extreme fatigue, and it was laborious to walk. Muscle aches and a blinding headache overnight added to my misery. This morning the headache was painful not blinding and the muscle aches not as intense. Had to return to bed right after eating soup, due to weakness. Chills abated by this morning. Speech slowed this morning while talking on the phone. Have spent the day in bed resting" 4/9/21: "Voice was back to normal by 8:30 pm last night. Slept well overnight - no chills or headache. Feeling stronger this morning - no headache!!! Arm still aches, but that is nothing c
64 2021-04-13 pain in extremity, muscle spasms UNABLE TO LIFT WITH LEFT ARM; BODY ACHES; MUSCLE SPASM; DIFFICULTY CONCENTRATING; SEVERE LEFT ARM PA... Read more
UNABLE TO LIFT WITH LEFT ARM; BODY ACHES; MUSCLE SPASM; DIFFICULTY CONCENTRATING; SEVERE LEFT ARM PAIN; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included ptsd, and concurrent conditions included osteoporosis, gluten allergy, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: 25/MAY/2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: cannabidiol, and paracetamol. On 17-MAR-2021, the subject experienced unable to lift with left arm. On 17-MAR-2021, the subject experienced body aches. On 17-MAR-2021, the subject experienced muscle spasm. On 17-MAR-2021, the subject experienced difficulty concentrating. On 17-MAR-2021, the subject experienced severe left arm pain. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced fever. Laboratory data included: Pain scale (NR: not provided) Described pain 12/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 22-MAR-2021, and headache on 26-MAR-2021, was recovering from body aches, muscle spasm, and difficulty concentrating, had not recovered from severe left arm pain, and the outcome of unable to lift with left arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
64 2021-04-13 pain in extremity Leg pain
64 2021-04-13 pain in extremity Patient reports rt leg/calf region pain
64 2021-04-13 pain in extremity Patient states she developed the typical flu-like symptoms over the first 2 days after receiving vac... Read more
Patient states she developed the typical flu-like symptoms over the first 2 days after receiving vaccine (achy, fatigued, sore arm) and improved after these first 2 days. On day 8 post vaccination, she began to develop a whole body rash that she describes as itchy and irritated. They are still present today 4/14/21, 2 weeks after vaccine administration
64 2021-04-13 tremor, slow speech, pain in extremity, coordination abnormal, weakness 4/8/21: "Six and a half hours after my Janssen vaccine I had started shaking with severe chills. By ... Read more
4/8/21: "Six and a half hours after my Janssen vaccine I had started shaking with severe chills. By 8 hours after my vaccine I had impaired coordination, extreme fatigue, and it was laborious to walk. Muscle aches and a blinding headache overnight added to my misery. This morning the headache was painful not blinding and the muscle aches not as intense. Had to return to bed right after eating soup, due to weakness. Chills abated by this morning. Speech slowed this morning while talking on the phone. Have spent the day in bed resting" 4/9/21: "Voice was back to normal by 8:30 pm last night. Slept well overnight - no chills or headache. Feeling stronger this morning - no headache!!! Arm still aches, but that is nothing c
64 2021-04-14 feeling hot, tingling reported feeling of warmth over her right after injection and tingling sensation in arm & "anxious &... Read more
reported feeling of warmth over her right after injection and tingling sensation in arm & "anxious & nervous". TX: mask removal ; opened car windows x 4 for air flow; emotional support for anxiety.
64 2021-04-14 night sweats Beginning 3/18/21: Initial headache. Fever greater than 103 F. Severe myalgias. Profound fatigue ... Read more
Beginning 3/18/21: Initial headache. Fever greater than 103 F. Severe myalgias. Profound fatigue and lassitude. Drenching night sweats. E.R. visit followed by 5 day in patient hospitalization. Discharged from hospital approximately 3/9/21. Symptoms not yet resolved. Patient has persistent fatigue and severe occipital headaches.
64 2021-04-14 pain in extremity, burning sensation, nerve pain Headache. Severe , burning, nerve pain in neck shoulders and both arms . Right arm swollen from elbo... Read more
Headache. Severe , burning, nerve pain in neck shoulders and both arms . Right arm swollen from elbow to wrists. Went to Dr. on 3-19-21 . Told to return in 3 days if not better. They said pulse was ok so prob not a clot. I had pain for two weeks but did not return. At end of two weeks swelling gone . Still some residual pain in right arm, but not constant.
64 2021-04-14 pain in extremity My legs have been hurting alot and it wasn't from the physical therapy
64 2021-04-14 pain in extremity Leg pain
64 2021-04-14 tingling, flushing, numbness Metallic taste in mouth 30 minutes after receiving vaccine. I have had a lot of stress (significant ... Read more
Metallic taste in mouth 30 minutes after receiving vaccine. I have had a lot of stress (significant other diagnosed with Stage 4 inoperable NSCLC ) and had been attributing the often present headache to that, but they were also accompanied by a butterfly pattern red flush across my nose. Acid reflux which I was attributing to stress or alendronate. Woke in the night 4/12 to severe acid reflux, nausea, headache, flush, thought maybe I was having a heart attack (I have no cardiac/BP issues); then last night, 4/14 about 6 PM, weird numbness tingling in right arm from center of my chest passed in about 5 minutes. Significant Other said I had the pattern flush on face at time of attack which faded as I began to feel better. I have not consistently felt at 100% since vaccination, but I have a lot going on and attributed it to that.
64 2021-04-15 slurring, bell's palsy, face paralysis One side facial muscle weakness, drooling, unclear speech, eye lid drooping, diagnosed Bell's Palsy.
64 2021-04-15 pain in extremity 3/30/2021: lost consciousness for hours at a time for 36 hours extreme pain in lower back and side 4... Read more
3/30/2021: lost consciousness for hours at a time for 36 hours extreme pain in lower back and side 4/10/2021 extreme pain in lower back, down left leg, shin, top of left foot. Could not stand or walk or lift anything without enormous difficulty. Restricted movement. Pain in all joints throughout body. Ongoing.
64 2021-04-15 tingling SHARP JABBING PAIN IN BODY; FEELING LIKE STICKING WITH NEEDLE ALL OVER; This spontaneous report rece... Read more
SHARP JABBING PAIN IN BODY; FEELING LIKE STICKING WITH NEEDLE ALL OVER; This spontaneous report received from a consumer concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced sharp jabbing pain in body. On 12-APR-2021, the subject experienced feeling like sticking with needle all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sharp jabbing pain in body and feeling like sticking with needle all over was not reported. This report was non-serious.
64 2021-04-16 flushing Flushing, light headedness
64 2021-04-16 nerve pain, pain in extremity I've had bad nerve pain in my injured leg and lower back which started above my knee and has now mov... Read more
I've had bad nerve pain in my injured leg and lower back which started above my knee and has now moved down my calf.. I've gone to PT and taken Gabapentin to help ease the pain. I've had it from April 7th through today(April 17th).
64 2021-04-17 pain in extremity Started morning after with terrible headache, pain in the eyes, nausea and sore arm. Few days later ... Read more
Started morning after with terrible headache, pain in the eyes, nausea and sore arm. Few days later felt tightness in the chest, shortness of breath and a cough started. Feeling unwell. Continued and went to urgent care. Covid 19 test negative. continued to feel the worse and went back again to urgent care. Same symptoms with nausea and headache on and off. another covid test negative and chest xray. looked ok. Continued with the same symptoms and went to Primary Care Cough worse and pain in chest. Blood work done. Looked ok. Woke up with terrible headache at 3am. Went to the ER. IV ,Blood work ,ct scan, ekg. No real answersBP elevated. Still struggling but cough improving.
64 2021-04-17 tingling, pain in extremity, weakness, difficulty speaking For the 1st 10 days it felt like my brain was swollen too big for my skull. Not like any headache I... Read more
For the 1st 10 days it felt like my brain was swollen too big for my skull. Not like any headache I have ever had. I did take some acetaminophen but it didn?t seem to quell the pain. While still at vaccine site I got a weird taste in my mouth, dry mouth and my voice started going hoarse. I stayed a while longer to be watched as I also had itching. I did not go into hives. I had pain in my body from time of injection ? the ?typical? sore arm didn?t set in until day 3-4. I had hot spots all over my body ? but not fever or rash. On 4/11/21 I broke out into a rash on my forehead that lasted about 4 days. What I want to specifically report is I like these zinger/sharp traveling pain from my temples to posterior head. Still having this sensation but not as frequently. They don?t last long but are noticeable at the time they are happening. The only way I can explain the pain is that it felt like when you break a blood vessel in you finger and it really, really hurts for a short while and then pain subsides. I started having these pin prick sensations within the first few days all over my body (arms, legs, back) but the frequency has decreased. Days 2-6 I was just wiped out and rested. I am still feeling lack of energy still today.
64 2021-04-17 unresponsive to stimuli When the patient enbered the observation area within a few minutes she fell to the ground and appear... Read more
When the patient enbered the observation area within a few minutes she fell to the ground and appeared unresponsive. When I arrived I noticed foaming around her mouth and she urinated on herself. No clonal movements noted. Pulse could not be felt so CPR was initiated. She woke up in about 30 seconds. Paramedics called and arrived within 5 minutes. Patient was awake and oriented. When asked she indicated that she had a history of a seizure many years ago. Paramedics transported her to a Medical Center.
64 2021-04-18 electric shock sensation, numbness, tingling Note this is in reference to initial report filed 03/31/2021 - Received Janssen vaccine for COVI-1... Read more
Note this is in reference to initial report filed 03/31/2021 - Received Janssen vaccine for COVI-19 in mid-March 2021. Over the next couple of days, became very ill, spent five days experiencing severe headache, disorientation, confusion, neck, shoulder, and back pain together with generalized arthralgias and myalgias. Around the 2nd week post-vaccination began to experience ?numbness and tingling? initially, affecting all fingers and toes; symptoms gradually evolved into ascending paresthesia affecting the upper and lower extremities. (worse in the upper extremities). Neurological symptoms are accompanied by painful electrical-like impulses running along my spine and elicited by flexing my neck (Lhermitte neurological phenomenon). Neurological signs and symptoms prompted me to go to the emergency room. Currently, I am under the care of a neurologist and undergoing extensive diagnostic workup. Present treatment: Glucocorticoids (tapering) and Gabapentin. Among the initial rule out diagnosis, were transverse myelitis, and Guillain Barre. Present preliminary r/o diagnosis: Post-vaccine immune reaction ? No definitive diagnosis yet.
64 2021-04-18 pain in extremity Pain in lower extremities. Comparable to "shin splints"
64 2021-04-19 weakness VOMITING; WEAKNESS; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a consumer conce... Read more
VOMITING; WEAKNESS; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included topiramate for migraine. On 13-APR-2021, the subject experienced vomiting. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, vomiting, nausea, and weakness. This report was non-serious.
64 2021-04-19 pain in extremity Patient complained of headache, diarrhea, and left arm pain that is ongoing since 4/6/2021. She cont... Read more
Patient complained of headache, diarrhea, and left arm pain that is ongoing since 4/6/2021. She contacted the clinic on 4/19/2021 with her symptoms. The patient was advised to go the the ER.
64 2021-04-19 pain in extremity Patient was vaccinated on 4/6/2021 and reports that on 4/16/2021, she started to experience joint pa... Read more
Patient was vaccinated on 4/6/2021 and reports that on 4/16/2021, she started to experience joint pains and muscle pain in her arms and legs, feeling fatigued and could barely stand. She reported these on 4/19/21. I advised her to contact her PCP to get evaluated for the signs/symptoms that she is experiencing to rule out anything severe. She did not seem to understand and asked to speak with the manufacturer. She said that she would contact the manufacturer and walked away. When I attempted to contact her again today on 4/20/21, the phone number she provided to us has been disconnected and we have no means of reaching her at this point in time. I am hoping she heeded my advice and contacted her PCP to get evaluated.
64 2021-04-20 weakness Patient stating day after vaccine was administered began experiencing nausea and vomiting and body a... Read more
Patient stating day after vaccine was administered began experiencing nausea and vomiting and body aches. 4/4/2021 patient states began to experience loss of appetite, fatigue and weakness. Described all food and beverage having an acidic taste. As of today, 4/21/2021 patient states symptoms are still persistent but seem to be subsiding.
64 2021-04-20 pain in extremity Pt has had left upper arm swelling and pain since the vaccine 7 weeks ago. Pt is being sent for ima... Read more
Pt has had left upper arm swelling and pain since the vaccine 7 weeks ago. Pt is being sent for imaging of the arm. Results not available yet.
64 2021-04-21 weakness, tingling April 2 -3 felt tired and achey and chills April 8 - 10 tingeling of face, left eye hurt. April 11 ... Read more
April 2 -3 felt tired and achey and chills April 8 - 10 tingeling of face, left eye hurt. April 11 no energy, left eye watering, lips swelling April 13 more swelling of face - Night of 13 wanted to rip my face off!!! April 14 swelling of eyes, lips, cheeks, hives on face and eyes. Felt miserable Zoom call with Doctor put on Medrol dose pack, Allegra, AM Zyrtec,PM Pepcid AC, purchased Epinephrine, Benadryl during day April April 19 more hives on chest
64 2021-04-22 discomfort CLOTS ON RIGHT LEG; HEADACHE; PRESSURE ON BOTH LEGS; PRESSURE ON HANDS; This spontaneous report rece... Read more
CLOTS ON RIGHT LEG; HEADACHE; PRESSURE ON BOTH LEGS; PRESSURE ON HANDS; This spontaneous report received from a patient via a company representative concerned a 64 year old Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered on 17-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient had experienced headache after vaccination. On 27-MAR-2021, the patient began to experience intermittent pain on right leg. On 30-MAR-2021, she experienced headache again and was still having leg pain; she visited the Emergency Room (ER) and was admitted on 30-MAR-2021. On 02-APR-2021, the patient experienced clots on right leg. On APR-2021, a catheter was placed in catheterization procedure and her right leg vein was unclogged of a clot. A second clot did not require removal because the vein had already unclogged itself after medication. The patient was administered unspecified anticoagulants. She was discharged on 5-APR-2021 and was prescribed ticagrelor which was then changed to clopidogrel. On 18-APR-2021, the patient experienced a headache again and feeling of pressure on legs and hands. Patient was advised to visit ER. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from clots on right leg and intermittent pain on right leg on 02-APR-2021, recovered with sequelae from headache on 19-MAR-2021, and had not recovered from pressure on both legs and pressure on hands. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 64 year-old Hispanic or Latino female with history of high blood pressure and diabetes was hospitalized for clots in her right leg 13 days after receiving the Janssen Covid-19 vaccine. Concomitant medications were not reported. On the day of her vaccination, she experienced a headache. Ten days later, she began to experience intermittent leg pain. Three days later (ie, 13 days post vaccination), she went to the emergency room (ER) and was admitted to the hospital. During the hospitalization, a clot was removed via catheterization and she was administered unspecified anticoagulants. A second clot resolved on its own without surgical intervention. After 6 days in the hospital, she was discharged with ticagrelor which was later changed to clopidogrel. She recovered from the clots. Thirteen days after discharge, she began to experience headache and "pressure" in both legs and hands. She was advised to go to the ER; no further information was provided. Based on the limited information, the relationship of the serious events with Janssen Covid-19 vaccine is considered indeterminant. Additional information is being sought.
64 2021-04-23 severe one side paralysis, inability to speak Department of Health received a call from her sister, in response to a call/letter/text sent out to ... Read more
Department of Health received a call from her sister, in response to a call/letter/text sent out to all recipients of the Janssen vaccine. She stated that her sister received the J and J vaccine on 3/12/21 (confirmed in State vaccine system) at the hospital where she receives her oncology care. She reported the following: "She had a massive stroke on MARCH 27TH, 2021 leaving her paralyzed on the right side with the inability to speak, swallow, or see. She was initially diagnosed with Ovarian cancer approximately three and one half years ago. She was chosen for a study with Pharmaceuticals and her diagnosis was changed to a vary rare form of cancer called clear cell carcinoma which originates in the gynecological area. She did have a previous stroke approximately three years ago, (just after original diagnosis) but she was on a different course of treatment at that time...Oncologists have explained that this most recent stroke event would not be considered a side effect of her current treatment routine. She wanted to bring it to the attention of the health department in case it needs to be looked at more closely by the J&J research/scientific team. She passed away on 4/5/21. Her current treatment consisted of palliative chemo only. " Decedent was a resident but was vaccinated in another state. After the CVA she was brought to the hospital and subsequently transferred to the Medical Center where she died on 4/5/2021. Sister is willing to speak with any investigators if deemed necessary.
64 2021-04-26 pain in extremity SORE ARM; This spontaneous report received from a patient concerned a 64 year old female. The patien... Read more
SORE ARM; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe chronic plaque psoriasis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.
64 2021-04-27 feeling cold, numbness, migraine 4-13-21 upon waking up, woke up migraines. took her migraine medication and migraine resolved. phleg... Read more
4-13-21 upon waking up, woke up migraines. took her migraine medication and migraine resolved. phlegm, fatigue, chills. 4-22-21 started numbness to lips and fingers with cold sensation. Reports no changes to color of skin so unlikely there is noticeable perfusion changes however advised to get seen at a HCF for this. spoke with pcp for the migraine.
64 2021-04-27 pain in extremity SORE ARM, AT FIRST ATTRIBUTED TO muscle ache, but later realized it was very specific to injection s... Read more
SORE ARM, AT FIRST ATTRIBUTED TO muscle ache, but later realized it was very specific to injection site, and very intense pain. I was unable to sleep more than a few short spurts the entire night as the pain was so intense. I read online that Benadryl was to be used for the pain, as well as ice. Originally I had used heat, before finding the information online. Nothing seems to help at this point.
64 2021-04-29 tingling, night sweats Immediately post injection severe stinging occurred. Three days later night sweats bodyaches low-gra... Read more
Immediately post injection severe stinging occurred. Three days later night sweats bodyaches low-grade fever diarrhea intense headache which lasted three weeks. Headache and bodyaches continued with night sweats for an additional two weeks.
64 2021-05-01 numbness, tingling My initial symptoms were very minor and occurred the day after I received the vaccine: 99.5 degree f... Read more
My initial symptoms were very minor and occurred the day after I received the vaccine: 99.5 degree fever and very mild headache. But several days later, both legs felt strangely weak from the calves to the feet. I also experienced occasional tingly feelings, pain, and often numbness. It was subtle at first but increased in intensity until April 21. I began to fear Guillain Barre syndrome. I scheduled a doctor's appointment for April 22, but the doctor's office cancelled and told me to go to the ER. At the ER bloodwork was done, which was normal. I was told to follow up with a neurologist if needed. It is now May 2 and my symptoms have slowly improved. It was frightening to have the symptoms for about a month. I was prepared to possibly feel unwell for several days, but expected neither my symptoms nor their duration.
64 2021-05-02 tingling, weakness Patient reported that she had a history of fainting after receiving other vaccines, so she had her f... Read more
Patient reported that she had a history of fainting after receiving other vaccines, so she had her friend drive her and got the vaccine administered in her car. A few minutes after getting the vaccine, the patient appeared to have a vasovagal episode where she stared off into the distance and stopped responding to questions for about 30 seconds to 1 minute before coming to. She reported having some tingling in her fingers and feeling a little weak afterwards. Provided the patient with a wet cloth for her forehead and some candy. Patient was a little shaken up but seemed to be back to normal in a few minutes. Contacted EMS just to be sure, and they checked her pulse and blood pressure, which were a little elevated but within normal limits. Patient said she was feeling better and did not need to go with them to the hospital. After waiting a few more minutes, she reported that she was feeling mostly back to normal and her friend drove them back home.
64 2021-05-04 seizure, migraine I started to get Migraines the day of the shot. I was nauseous and I did have seizure which only hap... Read more
I started to get Migraines the day of the shot. I was nauseous and I did have seizure which only happens twice a year. My seizures are not always triggered by migraine. I have a history of hives and I get reactions to bites. I decided to get the Johnson & Johnson because it seemed to be a better option. Ten days after the vaccine I had a Migraine that was so bad I had to go to the doctor. When I got there my blood pressure was high. I was given some migraine medicine, but it did not help. The migraine was there for four weeks after the shot. I still got a numbing headache after the shot until five weeks after the shot.
64 2021-05-05 pain in extremity Taken to directly to the ER from the site SOB Headache Chills Chest pain Dry hives Faintness Aching... Read more
Taken to directly to the ER from the site SOB Headache Chills Chest pain Dry hives Faintness Aching legs Heavy feeling in chest Vertigo following day Increase HR-as though heart was pounding in my chest
64 2021-05-09 burning sensation FEET AND ARMS BURNING; EYES BURNING; SWEATING; COULD NOT EAT; CHILLS; HEAD FELT IT WILL EXPLODE; EXT... Read more
FEET AND ARMS BURNING; EYES BURNING; SWEATING; COULD NOT EAT; CHILLS; HEAD FELT IT WILL EXPLODE; EXTREME NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 64 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced feet and arms burning. On 05-MAY-2021, the subject experienced eyes burning. On 05-MAY-2021, the subject experienced sweating. On 05-MAY-2021, the subject experienced could not eat. On 05-MAY-2021, the subject experienced chills. On 05-MAY-2021, the subject experienced head felt it will explode. On 05-MAY-2021, the subject experienced extreme nausea. On 05-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feet and arms burning, head felt it will explode, sweating, extreme nausea, fever, eyes burning, and could not eat. This report was non-serious.
64 2021-05-09 tremor Same day of vaccine around 3:30pm I started to shiver I showed a fever of 99 by 4:00pm I had incontr... Read more
Same day of vaccine around 3:30pm I started to shiver I showed a fever of 99 by 4:00pm I had incontrollable shaking with a fever 104.2 fever and sever headache. I had muscle pain on my back and neck. I had violent vomiting multiple times. I felt asleep and about 2 hours later I woke up and I had an SVT episode where my heart rate was beating was up to 200 by then the fever had gone down to 99. I called the nurse line.. they told me to call an ambulance. I called the ambulance they took me in they immediately put fluids they monitored me for 7 hours and they sent me home afterwards. I slept for 24 hours. Then on 4/27/2021 I had another SVT episode where my heart rate went up to 176 beats per minute. This lasted for 2.5 hours but I did not have to go to the the ER.
64 2021-05-10 pain in extremity Patient experienced soreness stiffnes to left arm, chills and headaches x 3 days. Patient no longer ... Read more
Patient experienced soreness stiffnes to left arm, chills and headaches x 3 days. Patient no longer has symptoms.
64 2021-05-11 pain in extremity Starting a week after the vaccine the left and right arm have been painful and difficult to move
64 2021-05-11 pain in extremity 3 days after vaccination with COVID-19 Janssen, patient developed acute right leg pain and swelling.... Read more
3 days after vaccination with COVID-19 Janssen, patient developed acute right leg pain and swelling. She did not present to the office until 5/11/2021. She was sent to the ER which showing extensive acute DVT and bilateral pulmonary embolism.
64 2021-05-12 pain in extremity BOTH LEG PAIN; HIVES / WORSENING HIVES; GASTROESOPHAGEAL REFLUX DISEASE; FELT LIKE HAVING HEART ATTA... Read more
BOTH LEG PAIN; HIVES / WORSENING HIVES; GASTROESOPHAGEAL REFLUX DISEASE; FELT LIKE HAVING HEART ATTACK; SLEEP INTERRUPTIONS; FLU-LIKE SYMPTOMS; ACHES; NAUSEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included neuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Investigation (NR: not provided) blood clots which were negative. On 24-MAR-2021, the subject experienced flu-like symptoms. On 24-MAR-2021, the subject experienced aches. On 24-MAR-2021, the subject experienced sleep interruptions. On 24-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced felt like having heart attack. On 27-MAR-2021, the subject experienced gastroesophageal reflux disease. On 30-MAR-2021, the subject experienced hives / worsening hives. On 04-APR-2021, the subject experienced both leg pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, aches, felt like having heart attack, sleep interruptions, gastroesophageal reflux disease, hives / worsening hives, and nausea on 2021, and both leg pain on APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
64 2021-05-13 weakness I received the vaccine on March 13, 2021. I did not have an immediate reaction, but began breaking o... Read more
I received the vaccine on March 13, 2021. I did not have an immediate reaction, but began breaking out in hives all over my body 24 hours later. I was lethargic, wanted to sleep all the time, and had no energy. This is gradually getting better, but still occurs. I periodically have headaches. After two full months I continue to have regular eruptions of hives on my arms. Prior to taking the vaccine I had no health issues, ran daily, and worked out regularly. I have just recently started walking, but have not been able to run.
64 2021-05-13 pain in extremity I had oral surgery four days before the vaccine with laughing gas and Novocain which lasted four hou... Read more
I had oral surgery four days before the vaccine with laughing gas and Novocain which lasted four hours. The morning after the vaccine I felt lightheaded and weird. I had heart palpitations and I was queasy. I started to walk back to my bedroom. The next thing I knew I woke up on the floor after passing out. After that I felt like my body was crumpled and I was disoriented. I could barely walk but I made it to the couch, and I had bumps in the front and back of my head near my ear. I was in a lot of pain and I think I was in shock. My foot was painful, and I saw a foot doctor. I had a doctor?s appointment and they did an EKG and they sent me to a Neurologist. It has been seven weeks I still have dizziness and nausea and it is hard to focus. I also have pain in my knee and my right arm.
64 2021-05-18 weakness Day 3 sudden severe onset of nausea, followed by vomiting and chills. Day 4 nausea and weakness Day5... Read more
Day 3 sudden severe onset of nausea, followed by vomiting and chills. Day 4 nausea and weakness Day5 back to normal- just sore from vomiting
64 2021-05-19 tremor INSIDES SHAKY LITTLE IN THE BEGINNING; HEADACHE; SUBJECTIVE FEVER; This spontaneous report received ... Read more
INSIDES SHAKY LITTLE IN THE BEGINNING; HEADACHE; SUBJECTIVE FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety issues, environmental allergy, allergy to bee stings, and anaphylactic reactions. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 208a21a, expiry: 21-JUN-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced insides shaky little in the beginning. On 17-MAY-2021, the subject experienced headache. On 17-MAY-2021, the subject experienced subjective fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from insides shaky little in the beginning on MAY-2021, headache on 18-MAY-2021, and subjective fever on 17-MAY-2021. This report was non-serious.
64 2021-05-19 tremor Started with severe chills and shakes. Nausea and diarrhea. Severe headache, chills and fever (101.4... Read more
Started with severe chills and shakes. Nausea and diarrhea. Severe headache, chills and fever (101.4). Arrived home about 7pm and fell asleep for 3 hours. Blood pressure was up to (159/82). Pulse (120). Unable/no desire to move. Called facility around 11pm with concern instructed to alternate Tylenol and Ibuprofen for fever. Started Tylenol and Ibuprofen around 1am (once I had some delivered). By morning only had a slight headache but was gone by late afternoon. Continue to have fatigue.
64 2021-05-21 feeling cold LIGHT HEADED; FELT COLD; FEVER; This spontaneous report received from a patient concerned a 64 year ... Read more
LIGHT HEADED; FELT COLD; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included full hysterectomy, and concurrent conditions included no alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced light headed. On 19-MAY-2021, the subject experienced felt cold. On 19-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.1 F, 100.9 F, 101.5 F. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fever, light headed, and felt cold. This report was non-serious.
64 2021-05-22 tremor Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightnes... Read more
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Anxiety-Medium, Systemic: Hypertension-Medium, Systemic: Shakiness-Mild, Additional Details: Patient experienced high levels of apprehension and anxiety pre-administration. After 15 minute observation period, pt was visibly anxious and reported a "weird" feeling on her left side, local to administration and radiating from left shoulder. Pt BP was read as 173/109 and 5 minutes later 168/95. Pharmacist advised pt leave site due to perceived anxiety/worry, measure again in an hour, and report to ER/Urgent care if BP still above 120/80. RPh will follow up with pt following day.
64 2021-05-24 weakness, breast pain, tremor, pain in extremity HEART BEATING FAST; HEART "SKIPPING BEATS"; ACHING JOINTS/JOINTS HURTING; NAUSEATED; HURTING ALL OVE... Read more
HEART BEATING FAST; HEART "SKIPPING BEATS"; ACHING JOINTS/JOINTS HURTING; NAUSEATED; HURTING ALL OVER; DIZZY; COULDN'T SLEEP; STOMACH FELT "BLOWN UP"; NO APPETITE; HURTING "DOWN REAL LOW" IN ABDOMEN; HAD TO URINATE ALOT; SHAKINESS; ITCHING ARM; FATIGUE; WEAKNESS/NO ENERGY; SORE ARM; DID NOT FEEL WELL; CHILLS; BREASTS SORE; SEVERE HEADACHE/SORE SPOTS ON HEAD; UNDER ARMS SORE; SUSPECTED COVID; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dental surgery, and left arm broken. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced suspected covid. On MAY-2021, the subject experienced breasts sore. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced did not feel well. On MAY-2021, the subject experienced sore spots on head. On MAY-2021, the subject experienced under arms sore. On 11-MAY-2021, the subject experienced shakiness. On 11-MAY-2021, the subject experienced itching arm. On 11-MAY-2021, the subject experienced weakness/no energy. On 11-MAY-2021, the subject experienced sore arm. On 11-MAY-2021, the subject experienced fatigue. On 11-MAY-2021, the subject experienced severe headache. On 12-MAY-2021, the subject experienced hurting all over. On 12-MAY-2021, the subject experienced dizzy. On 12-MAY-2021, the subject experienced couldn't sleep. On 12-MAY-2021, the subject experienced stomach felt "blown up". On 12-MAY-2021, the subject experienced no appetite. On 12-MAY-2021, the subject experienced hurting "down real low" in abdomen. On 12-MAY-2021, the subject experienced had to urinate alot. On 12-MAY-2021, the subject experienced aching joints/joints hurting. On 12-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced heart beating fast. On 18-MAY-2021, the subject experienced heart "skipping beats". Treatment medications (dates unspecified) included: ibuprofen, naproxen sodium, and amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate. The action taken with covid-19 vaccine was not applicable. The outcome of the severe headache, shakiness, weakness/no energy, fatigue, sore arm, itching arm, did not feel well, hurting all over, hurting "down real low" in abdomen, nauseated, dizzy, chills, couldn't sleep, stomach felt "blown up", no appetite, had to urinate alot, heart beating fast, heart "skipping beats", breasts sore, aching joints/joints hurting, sore spots on head and suspected covid was not reported. This report was non-serious.
64 2021-05-25 muscle spasms, unresponsive to stimuli, pain in extremity, burning sensation Complaint of cramping in legs on April 26. 2021. Resolved for a short period of time. Earlier in May... Read more
Complaint of cramping in legs on April 26. 2021. Resolved for a short period of time. Earlier in May 2021 Complaint of Left Flank pain with Radiating pain to Left Thigh. Appointment with Orthopod cancelled due to inability to drive with pain. On May 15, 2021 complaint of continued Left Flank Pain Radiating to to Left thigh with burning and discoloration. Unresponsive on May 16, 2021. Pronounced Dead at 1:52pm by County Coroner. Cause of death noted as CV. Nature of death :Natural This is being reported in case another patient complains of these same symptoms. There may or may not be a Correlation with this Death and The Jassen Covid-19 Vaccine
64 2021-05-26 pain in extremity A lump appeared shortly after the vaccination was given and remained for six weeks. After this time... Read more
A lump appeared shortly after the vaccination was given and remained for six weeks. After this time the lump started to decline and pain in the arm started. This pain ran all the way down my arm to my fingers from the injection site. At times the pain is unbearable and requires that I take Tylenol and put on a Lidocaine 1% patch.
64 2021-05-27 pain in extremity LE edema, purpura, and pain.
64 2021-05-29 pain in extremity Muscle and Bones aches. @ weeks later i had severe pain in my right leg and hip.
64 2021-06-01 weakness She got her vaccine, and a couple of weeks after getting it she woke up and she was off. She wasn't... Read more
She got her vaccine, and a couple of weeks after getting it she woke up and she was off. She wasn't dizzy but wasn't herself, felt off. Then she got petechia in both legs and she took it easy, drank a lot of water. She took it easy, but ever since then her energy is not there, she is "zapped". She has changed her whole routine, she is pretty active and now she cannot do much due to the fatigue. She is now really concerned as it is lasting. She feels like she is mentally confused. She could not tell me her address without looking it up first. It has started to subside some the feeling of being off. She feels like that she has no blood in her. She feels like she's out of iron, and zapped of energy. She has not called her doctor.
64 2021-06-01 migraine Migraine, fever & stabbing pains from heart to pelvic bone. It felt like 40+ knives stabbing me for ... Read more
Migraine, fever & stabbing pains from heart to pelvic bone. It felt like 40+ knives stabbing me for 7 1/2 hours.
64 2021-06-06 feeling hot, feeling cold, tremor For the past six weekends patient gets severe fever of coldness shaking and lies on a full length he... Read more
For the past six weekends patient gets severe fever of coldness shaking and lies on a full length heating pad to warm up. Then experiences fever of hotness sweating and cannot cool down. Muscle aches, joint aches and hurts to touch the skin and exhaustion. The aches and fever last 4 - 6 hours and the next day all she can do is sleep.
64 2021-06-08 tingling 35 minutes after injection experienced dizziness, shortness of breath, tingling of lips, tongue, fin... Read more
35 minutes after injection experienced dizziness, shortness of breath, tingling of lips, tongue, fingers and toes. Went to nearest Emergency room, 8 minutes away. Treated with IV Solumedrol, Benedryl, and Pepsid. Stabilized and discharged after 2 hours. Minor symptoms for 2-3 more days. Back to normal now.
64 2021-06-11 pain in extremity, night sweats COULD NOT SWALLOW HER FOOD DUE TO NAUSEA; COULD NOT BREATHE VERY WELL; NIGHT SWEATS; RIGHT ARM AND L... Read more
COULD NOT SWALLOW HER FOOD DUE TO NAUSEA; COULD NOT BREATHE VERY WELL; NIGHT SWEATS; RIGHT ARM AND LEG BEGAN TO HURT; CHILLS; HEADACHE; TIREDNESS OR FATIGUE WAS UNGODLY; NAUSEA; VERTIGO-LIKE FEELING; PASSED OUT ON FLOOR; CHEST PAINS HERE-AND-THERE NOT CONSTANT; This spontaneous report received from a patient concerned a 64 year old white and non Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included colitis, non alcohol user, smoker (2 cigarettes per day), allergy to penicillin cause chest pains and swelling, allergy to sulfa cause chest pains and swelling, and medication sensitive. The patient had no drug abuse or illicit drug use. The patient experienced sick when treated with influenza vaccine (flu shot), chest pains and swelling when treated with codeine, and naproxen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, 1 in total, administered at right arm on 13-MAY-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient could not swallow food due to nausea and could not breathe very well (difficulty in breathing) and fatigue was ungodly. On 13-MAY-2021, the patient had tiredness, headache, nausea, night sweats and chills after took the vaccine. The right arm and right leg began to hurt. Tiredness was not gone away and Lightheadedness here-and-there. The patient had chest pains here-and-there, that was not constant. The patient felt like she had vertigo and passed out on her floor twice last week in MAY-2021 and on 04-JUN-2021. The Lightheadedness and dizziness presented again on 04-JUN-2021. A chill was come-and-go. The right arm and leg pain have resolved on 04-JUN-2021. She was not reached out to her primary care provider for medical advice. Patient mentions that she was medication sensitive. The patient had tendency for low blood pressure, but her low blood pressure was fine at 120/80 mmHg. The patient took Norco for pain and occasionally took Zofran for nausea. The patient had history of colitis and these medications help her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats, and right arm and leg began to hurt on 04-JUN-2021, had not recovered from tiredness or fatigue was ungodly, chills, vertigo-like feeling, headache, chest pains here-and-there not constant, passed out on floor, and nausea, and the outcome of could not breathe very well and could not swallow her food due to nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210612160-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passed out. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.
64 2021-06-21 migraine No side effects until third day. Then migraines, tiredness, dizziness, nausea.
64 2021-06-22 tremor Six hours after the vaccine I got chills, headache, stomach upset and swelling in my lower face and ... Read more
Six hours after the vaccine I got chills, headache, stomach upset and swelling in my lower face and throat. I had body aches all over my body but no fever or pain at the injection site. Those symptoms lasted for ten days. I went to ER. I was given medication for the nausea and pain. The chills were a little better by then. The medication helped with everything but the headache. The headache is constant at the back right of my head. I then get other head pain at the same time in my temples on the left. It is a sharp shooting pain. I get flashes of light in my eyes and my eyes start twitching at the sides. I also get pain at the top of my head on the left hand side on occasionally which comes after the temple pain. I sometimes get head pain on the right side with deep concentration. I have recently started to get tremors in my right hand. Sometimes the headache wakes me up at night. I wake up every day with a headache and it has been thirteen weeks. I can not drive or concentrate. I have seen a neurologist but I am still having trouble scheduling scans. I have tried some prescription pain medication and it did not work. I have taken two courses of steroids.
64 2021-06-23 numbness Numbness on left side of face
64 2021-06-27 bell's palsy Systemic: Bell's Palsy-Severe, Additional Details: back pain, guillain barre
64 2021-07-01 numbness 4 hours after vaccination, had numbness of left side of face in the trigeminal nerve region. Later h... Read more
4 hours after vaccination, had numbness of left side of face in the trigeminal nerve region. Later had fever an aches which resolved, but as of 7.2.21, still has numbness in face which is about 2/3 better but still present. Has no facial motor deficits.
64 2021-07-05 tingling Tingling in extremities - it started with my toes and went up to my hands. And continues to present... Read more
Tingling in extremities - it started with my toes and went up to my hands. And continues to present. Doctor visit ER. Have an upcoming visit to Neurologist hopefully. No Treatment as of yet.
64 2021-07-11 weakness On the same day I got the vaccine and the next day, I had fever, body aches, and malaise; I was in b... Read more
On the same day I got the vaccine and the next day, I had fever, body aches, and malaise; I was in bed for 2 days. I had a lack of energy that was worse than it had been before the vaccine. On or about 4/14/2021, I woke up at about 2:00AM with chest pain, pain in the left shoulder and in the left side of the neck. The symptoms subsided after some time. I had low oxygen saturation levels; I knew this, because I used a pulse oximeter that had been used by my late husband. The low oxygen saturation levels have been ongoing ever since, and I have had periods of rapid heart rate and oxygen levels that are even lower than the low levels I have experienced since the vaccine. I have also had periods of chest pains at times, so my PCP referred me to both a pulmonologist and a cardiologist.
64 2021-07-11 tingling, pain in extremity Almost immediately these symptoms appeared: Extremely achy joints, swollen index finger on right ha... Read more
Almost immediately these symptoms appeared: Extremely achy joints, swollen index finger on right hand, feet and hands hurt, facial filler in right side of chin dissolved completely. Approximately two weeks after vaccine feet and lower legs have pins and needles feel with nerves tingling. This is a 24 hour a day problem and quite concerning. My joints pop and creak like they suddenly aged and have no lubrication. These are all NEW symptoms/issues. I?m concerned that this is a long term and/or permanent medical issue for me! I WOULD LIKE SOME ANSWERS!!!!!
64 2021-07-13 pain in extremity, numbness and pain in extremities J and J vaccine: 40 min. after shot, my lower lip began to tingle, then went numb, next my upper lip... Read more
J and J vaccine: 40 min. after shot, my lower lip began to tingle, then went numb, next my upper lip, next nose felt funny. chest felt tight, no wheezing. Was still at Clinic so I went to Urgent care. I used my albuterol inhaler, chest tightness resolved. Treated in UC with solumedrol, famoditine, 1 liter NaCl. My allergist had me on 2 Zytec, and 2 famoditine the day of shot. Went to urgent care 7/5 for neuropathy. Saw neurologist on 7/8/21. Today is 12 days after the vaccination. My peripheral neuropathy is so bad I can't work. I have constant pain in my shoulder girdle, lower back thighs, calves, feet, hands, and visceral. My PCP won't give my any pain meds, my pain is 8/10.
64 2021-07-14 facial pain Extreme jaw and face pain along with fast heart rate
64 2021-07-16 weakness FALLING MORE AND WALKS WITH A CANE DUE TO WEAKNESS; SORE MUSCLES; BODY ACHES; RUNNY NOSE; This spont... Read more
FALLING MORE AND WALKS WITH A CANE DUE TO WEAKNESS; SORE MUSCLES; BODY ACHES; RUNNY NOSE; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 200.2 pounds, and height was 65 inches. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. patient does not remember the name of the blood pressure medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204a21a, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced runny nose. On 02-JUL-2021, the subject experienced body aches. On 02-JUL-2021, the subject experienced sore muscles. On 06-JUL-2021, the subject experienced falling more and walks with a cane due to weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, sore muscles, runny nose, and falling more and walks with a cane due to weakness. This report was non-serious.
64 2021-07-16 tingling, pain in extremity, nerve pain LITTLE BRUISES TO LEFT HAND AND ARM UNDER THE SKIN; TINGLING UP LEG TO THE KNEE LIKE PINS AND NEEDLE... Read more
LITTLE BRUISES TO LEFT HAND AND ARM UNDER THE SKIN; TINGLING UP LEG TO THE KNEE LIKE PINS AND NEEDLES/TINGLING ALL UP AND DOWN LEFT LEG; HURTS AFTER A MINUTE OR TWO OF WALKING OR STANDING/IT ONLY HURT WHEN PUT PRESSURE ON LEG; HARD TO SLEEP AT NIGHT; PAIN IS BELOW KNEE ABOUT 3/4 OF WAY DOWN TO THE ANKLE, NOT QUITE ABLE TO PINPOINT EXACT LOCATION; PAIN IN LEFT THIGH; LOWER LEFT LEG PAIN; NERVE PAIN IN LEG ALL ON LEFT SIDE; LEFT HIP BECAME SORE; CYST IN LEFT ARMPIT; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no related medical history. patient feels normal, super good and fine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced cyst in left armpit. On MAY-2021, the subject experienced left hip became sore. On 25-MAY-2021, the subject experienced nerve pain in leg all on left side. On 25-MAY-2021, the subject experienced lower left leg pain. On an unspecified date, the subject experienced little bruises to left hand and arm under the skin, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg, hard to sleep at night, pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location, and pain in left thigh. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cyst in left armpit on 14-APR-2021, and little bruises to left hand and arm under the skin, pain in left thigh, and left hip became sore, had not recovered from nerve pain in leg all on left side, and lower left leg pain, and the outcome of hard to sleep at night, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg and pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
64 2021-07-16 tremor DOUBLE VISION; SLEPT THE WEEKEND AWAY; STUMBLING POST-VACCINATION; EXTREMELY TIRED/ TIREDNESS; SHAKI... Read more
DOUBLE VISION; SLEPT THE WEEKEND AWAY; STUMBLING POST-VACCINATION; EXTREMELY TIRED/ TIREDNESS; SHAKINESS/UNSTEADINESS; LOSS OF APPETITE; DIZZY; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 115 pounds, and height was 64 inches. The patient's past medical history included emphysema, and smoker, and concurrent conditions included non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 04A21A expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 16:15 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced shakiness/unsteadiness. On 10-JUL-2021, the subject experienced loss of appetite. On 10-JUL-2021, the subject experienced dizzy. On 10-JUL-2021, the subject experienced slept the weekend away. On 10-JUL-2021, the subject experienced stumbling post-vaccination. On 10-JUL-2021, the subject experienced extremely tired/ tiredness. On 13-JUL-2021, the subject experienced double vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from double vision, and had not recovered from extremely tired/ tiredness, shakiness/unsteadiness, loss of appetite, dizzy, slept the weekend away, and stumbling post-vaccination. This report was non-serious.
64 2021-07-19 limb paralysis Following immunization patient had a fever overnight and feeling of being "hit by a mack truck" whic... Read more
Following immunization patient had a fever overnight and feeling of being "hit by a mack truck" which caused fatigue and she had slept it off. Patient had lump that developed behind left knee two weeks after vaccination. She described the feeling of losing the ability to move her left leg and a feeling of a rip when getting out of her boat. She called her chiropractor who told her to get to the ED and stated she likely had a clot. She was seen in the clinic and was taken by ambulance to the hospital and had a surgery to remove a clot she was told was from her left ankle to her left knee. She had a Boston Scientific Wallstent placed (lot number 25506141) and was hospitalized for a week duration. Patient taking Lasix, blood thinner, aspirin, and antibiotic. She was taken off of work for a month duration.
64 2021-07-19 muscle spasms Day after vaccine: chills so hard I had charlie horses; bones ached; nauseous and diarrhea In May, T... Read more
Day after vaccine: chills so hard I had charlie horses; bones ached; nauseous and diarrhea In May, Telemed visits to Dr. sneezing, sore throat followed by coughing. wheezing, tightness of chest, shortness of breath, tired, nauseous. All COVID tests came back negative. Blood test - no antibodies, no COVID, Seeing a heart Dr. for continued shortness of breath and pressure on my chest. Had stress test and echo test.
64 2021-07-26 weakness, migraine Initially dizzy and lightheaded after the injection, heart racing, lasted about 30 minutes. 24 hour... Read more
Initially dizzy and lightheaded after the injection, heart racing, lasted about 30 minutes. 24 hours later extremely tired, no energy, sore upper L arm, nausea, no appetite, talking, reading, writing/typing almost impossible. This lasted for 3 days. Developed a migraine headache(had migraines 30 years ago) that lasted for the following 10 days and then just a normal headache for 2 more days. I took Advil and Tylenol without any relief. Called the nurse at physicians office who told me to increase the dosage and to use only Advil. If it got worse to go to urgent care to get Tordal and/or steroid injection. I didn?t want anymore side effects of medication so I just toughed it out. The injection site became the size of a half of a tennis ball, was red and hot to touch. It is now 18 days later and there is still a small knot and tender to touch. Trouble sleeping through the night also started at the time of vaccine and finally stopped last night. I felt like I was in a dark hole for the first 3 days and was then in a fog for a week. I had blurry vision off and on for the first 3 days and then again on day 5.
65 2021-03-07 pain in extremity, facial paralysis Bleeding and pain at injection site; Droopy left side of face, pain in upper left jaw, below left ey... Read more
Bleeding and pain at injection site; Droopy left side of face, pain in upper left jaw, below left eye, upper left arm and left shoulder/neck; Transient headache and pain in left leg with ankle swelling.
65 2021-03-07 pain in extremity On 3/7/2021 after I returned home, I ate broiled, skinless chicken, salad and small amount of corn ... Read more
On 3/7/2021 after I returned home, I ate broiled, skinless chicken, salad and small amount of corn at 5:00pm. I started having diarrhea about 5:30pm. Later in the evening around 8:30pm, I had more diarrhea. Around the same time I became very, very sleepy and had extreme fatigue. My right arm where I received the shot did not hurt and still does not hurt. Around 6:00pm, my left arm starting hurting in the same spot where I received the vaccine in the right arm. On the morning of 3/8/2021, I ate breakfast consisting of whole wheat bread and peanut butter and weak coffee (my usual breakfast) and had diarrhea again soon after eating. At 3:30pm, I ate broiled, skinless chicken, green beans and small amount of instant mashed potatoes. Around 5:00pm, I had diarrhea again. I have been drinking a great deal of water on both 3/7/2021 and 3/8/2021 as I normally do every day. At 6:30pm, I had more diarrhea. Soon after, I took two imodium gelcaps and hoping they will help the diarrhea. My left arm has become increasingly more sore and hurts in the muscle. No other symptoms.
65 2021-03-08 feeling cold headache, nausea, aching, chilling
65 2021-03-08 pain in extremity Patient received Janseen COVID vaccine. The first 1/2 of the vaccine was given easily IM to the left... Read more
Patient received Janseen COVID vaccine. The first 1/2 of the vaccine was given easily IM to the left deltoid and then the patient complained of severe arm pain, tensed her muscles, and the last 0.25ml was difficult to inject. Then the patient became hypotensive 90/45, dizzy, and felt like she was going to pass out. She was laid in the supine position, given a cool cloth for her forehead and monitored for approx. 45 minutes. Her blood pressure remained 90/60, 96/56 at discharge. Her heart rate ranged from 55-65, regular. Her son came to take her home as we did not feel comfortable with the patient driving. The patient was continuously monitored by the NPs and APCT. She ambulated without difficulty and was discharged home. She was given information for V-safe to report her reaction and advised to follow up in the ER for any SOB, difficulty breathing, difficulty swallowing, syncope, CP, etc.
65 2021-03-09 weakness nausea, aches, headache, very tired and weak
65 2021-03-09 tremor Shot at 2:00 pm. Chills at 7:00 pm. Violent shaking from the chills that hurt my back & chest. Hea... Read more
Shot at 2:00 pm. Chills at 7:00 pm. Violent shaking from the chills that hurt my back & chest. Headache sore throat, dizzy
65 2021-03-10 flushing pt waiting 15min no problem then return to pharmacy 30 minutes later with facial flushing no other s... Read more
pt waiting 15min no problem then return to pharmacy 30 minutes later with facial flushing no other symptoms ask pt to wait longer (gave ice pack) took blood pressure which was elevated and bout 45-1 hr later stilled had flushing and arm seemed bit redder gave 10ml benadryl 12.5/5ml and recheck blood pressure which was still elevated. around 5:45 pm pt said she felt fine and decided to go home. to her to keep eye on symptom and follow with er if got worse.
65 2021-03-11 tremor, migraine Began with violent shakes and chills. Migraine type headache developed, followed by nausea feeling,... Read more
Began with violent shakes and chills. Migraine type headache developed, followed by nausea feeling, all over sore muscles. This lasted about 12 hours, then slowly started to subside. By second day, nausea gone, headache gone, but very light-headed. On third day, still very light-headed.
65 2021-03-11 unresponsive to stimuli PATIENT FAINTED AND BECAME UNRESPONSIVE BUT BREATHING WITH PULSE, PARAMEDICS ARRIVED WITHIN FEW MI... Read more
PATIENT FAINTED AND BECAME UNRESPONSIVE BUT BREATHING WITH PULSE, PARAMEDICS ARRIVED WITHIN FEW MINUTES, PATIENT CALLED FEW HOURS LATER TO INFORM US THAT SHE IS OK AND HER ADVERSE REACTION WAS DUE TO HYPOTENSION.
65 2021-03-12 burning sensation I noticed a red rash on my legs, arms, and torso at about 8 pm yesterday, March 12; it is red blotch... Read more
I noticed a red rash on my legs, arms, and torso at about 8 pm yesterday, March 12; it is red blotches (no hives) and feels more like a sunburn . There is a burning sensation with mild itching and red blotches/spots. I contacted my physician who recommended OTC treatment at home and advised me to report it to VAERS. It is mild in terms of impact but not expected four days after the vaccination date.
65 2021-03-13 cold extremities, tremor, muscle spasms started during dinner, 6pm, hands and feet cold, chills continued and increasingly worse, shaking, m... Read more
started during dinner, 6pm, hands and feet cold, chills continued and increasingly worse, shaking, muscle spasms, headache, temp 103, vomited, ache muscles. Tylenol had no notable affect. Next day 3/8/21 chills subsided, groggy, headache #7 on pain scale with light sensitivity. Tylenol little affect. A metal taste in my mouth, food didn't taste right. Next day 3/9/21 felt much better. Please note I had hydrated well previous to getting the vaccine.
65 2021-03-14 tremor, feeling hot Around 10-11 hours after the injection, I began to feel body aches and soreness around my neck and u... Read more
Around 10-11 hours after the injection, I began to feel body aches and soreness around my neck and upper back. I started getting chilled but was very hot and feverish. I went to bed around 10:00pm and had extreme body aches, shaking with chills and had a fever. I took tylenol around 4am, when my temperature was 100.7. The fever and aches subsided by the time I got up around 7am, but I was tired all day. Took another tylenol around 1pm and started feeling normal, fine. No other issues.
65 2021-03-15 migraine, weakness About 4hours after being vaccinated, I started to feel weak. I wen to sleep. Woke up an hour later (... Read more
About 4hours after being vaccinated, I started to feel weak. I wen to sleep. Woke up an hour later (9PM) with fever (100.5), HUGE migraine and being nauseous. I threw up, tried to go back to sleep but couldn't because of the migraine and fever. Decided to take 2 Tylenol, but I vomited about 20 mins later. All night, I hardly could sleep at all, so sick I was feeling (and I'm never sick!). No reaction at all on the site of the vaccine, no redness, no swelling at all. All day today (day after the vaccine), I have felt really weak, slightly feverish (though less than last night), with a persistent headache.
65 2021-03-17 weakness WITHIN 2-3 MINUTES OF ADMINISTRATION PATIENT BEGAN TO FEEL WEAK, LIGHTHEADED AND WAS SWEATING. PATIE... Read more
WITHIN 2-3 MINUTES OF ADMINISTRATION PATIENT BEGAN TO FEEL WEAK, LIGHTHEADED AND WAS SWEATING. PATIENT WAS EXAMINED AND ALL VITAL SIGNS WERE STABLE. WE SUPPLIED WET CLOTH AND COOL AIR. PATIENT THEN SAID HE THROAT FELT HEAVY AND LIKE SHE COULDNT SWALLOW. PT WAS ADMINISTERED EPI 0.3ML IM INTO R DELTOID. MONITORED PATIENT FOR ANOTHER 15 MINUTES AND TOLD TO GO TO ER FOR FUTHER WORKUP. PATIENT WAS STABLE AT THE TIME OF DICHARGE.
65 2021-03-18 pain in extremity pt stated that after she took the covid vax her arm was red and hurting very badly. Later she felt... Read more
pt stated that after she took the covid vax her arm was red and hurting very badly. Later she felt nauseas, had muscle pain and headache. Temp was 100.4. She took 2 Tylenol and felt some better. By 3/17/2021 she began having more muscle pain in her arms and legs and her arm is still very sore. Pt states she will call her PCP for medical advice.
65 2021-03-23 feeling of body temperature change Janssen Covid-19 vaccine EUA First 24 hours, tired and achy. 36 hours in at bedtime felt shivery an... Read more
Janssen Covid-19 vaccine EUA First 24 hours, tired and achy. 36 hours in at bedtime felt shivery and cold for a few hours then hot and sweaty for a few more hours. In the morning I felt fine. Very mild symptoms.
65 2021-03-31 migraine First day developed a headache, and a bad rash on my chest that was very itchy for 2 days, rash was ... Read more
First day developed a headache, and a bad rash on my chest that was very itchy for 2 days, rash was visible for approx. 2 weeks. (took a picture), second day had flu like symptoms, headache turned into a migraine 24 hours after initial headache began. Had joint pain, slight cough and lower back ache as well as headache until Saturday morning 3/13/2021. Took Tylenol at home and got extra rest until all symptoms went away.
65 2021-03-31 muscle spasms Severe Spasms in all muscles from feet all the way up through back, lasting for up to 10 seconds and... Read more
Severe Spasms in all muscles from feet all the way up through back, lasting for up to 10 seconds and occuring every 10 to 15 minutes. I felt as if my entire body was frozen during the spasms. Had a very hard time breathing. Called 911, no fever, taken to emergency room. Was given an injection of ativan and it relieved the spasms. I slept the rest of that night and woke up very sore in all muscles for 5 days after.
65 2021-04-02 numbness Patient received Janssen vaccine @ 11:44 am, while in the recovery area @ 12:01 pm, c/o numbness in ... Read more
Patient received Janssen vaccine @ 11:44 am, while in the recovery area @ 12:01 pm, c/o numbness in the left neck area, blurry vision> VS 136/80, 63,20, Sats 99% on RA. 12:05, patient stated numbness was no longer present, VS @ that time: 140/92, 55, 24 Sats remained unchanged. Continued to monitor, final VS check @ 12:10 pm, 152/96, 54, 22 Sat's remain unchanged, no further c/o of discomfort of any kind. DC from recovery @ 12:25, all symptoms resolved, gait steady accompanied by Sister (who was present for vaccine as well).
65 2021-04-02 pain in extremity Arm pain, chest heaviness, general malaise and achyness
65 2021-04-02 tingling, numbness Janssen COVID19 Vaccine EUA starting Tuesday morning, 3/30/2021 hands and feet are numb and tingling... Read more
Janssen COVID19 Vaccine EUA starting Tuesday morning, 3/30/2021 hands and feet are numb and tingling, like the nerves are exposed. went to emergency room 4/1/2021 -- could not reach a conclusion without further testing. Told me to report this and call my doctor to arrange further testing to find out the cause -- CT scans, etc.
65 2021-04-05 brain damage, mild one side paralysis Patient vaccinated by EMS on 3/29/21, EMS notified clinic that patient was taken to the Hospital fo... Read more
Patient vaccinated by EMS on 3/29/21, EMS notified clinic that patient was taken to the Hospital for a stroke on 4/1/21
65 2021-04-06 feeling cold Felt cold, and chilled after going to bed, and feverish. took temperature and it was 101.8. couldn'... Read more
Felt cold, and chilled after going to bed, and feverish. took temperature and it was 101.8. couldn't sleep tossed and turned most of the night until I took Tylenol PM
65 2021-04-06 muscle spasms Scratchy throat within 2 hours of vaccine inoculation, a raging headache started within 3 hrs of Joh... Read more
Scratchy throat within 2 hours of vaccine inoculation, a raging headache started within 3 hrs of Johnson & Jonson (Janssen) vaccine, massive muscle cramping starting at 1800 and continuing through the night - I drank a gallon of water between 6 PM and 9 PM on 04/06/2021 and then 3 more 1/2 liter bottles during the night. None of it came out in the usual manner -- I had cramping of my left side muscles across my rib cage between 4 PM and 6 PM on 04/06/2021 and then massive lower leg cramps starting at about 10 PM 04/06/2021 lasting until 0300 AM 04/07/2021
65 2021-04-07 weakness Extreme chills, fever (102), body aches, vomiting, diarrhea, extreme fatigue, strange taste in mouth... Read more
Extreme chills, fever (102), body aches, vomiting, diarrhea, extreme fatigue, strange taste in mouth, and headache. This lasted for 8 days and I'm still dealing with the fatigue and lack of energy. I took alternating doses of tylenol and motrin and drank lots of fluids. I had to miss 6 days of work because I was too sick to teach.
65 2021-04-07 slurring Night of shot experienced fever of 101, nightmares and slurred speech. The following day experience... Read more
Night of shot experienced fever of 101, nightmares and slurred speech. The following day experienced fatigue. By the second day post vaccination memory impairemt. By the third day post vaccination has gait unsteadiness and fell six times. The 4th day post vaccination left arm weakness and could not use arm. accompanied by slurred speech.
65 2021-04-07 flushing Itching, skin, scalp, ears, flushed skin
65 2021-04-07 tremor Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Additional Details: uncontrolable shaking.... Read more
Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Additional Details: uncontrolable shaking. patient stated that benadryl has helped her in the past with this type of reaction. gave benadryl. patient has a history of having reactions to vaccines. 911 was called and brought her to the hospital.
65 2021-04-08 migraine, feeling cold When needle came out I felt like my upper arm was filled with lead - very heavy feeling for about 8 ... Read more
When needle came out I felt like my upper arm was filled with lead - very heavy feeling for about 8 minutes. About 2 hours later I felt very fatigued and slept for 2 hours. Woke up at 4:30 am next day (04/08/21) with a raging migraine, unbearable nausea and cold to the bone. Vomited 2 times in the day. After drinking some ginger beer at 3 pm the nausea was gone by 3:30 pm. Migraine gone by 7 pm and freezing cold feeling gone this morning (04/09/21).
65 2021-04-08 pain in extremity ^ hours after injection my arm was aching. Then Head ache set in by 7pm. pain with neck and head an... Read more
^ hours after injection my arm was aching. Then Head ache set in by 7pm. pain with neck and head and fever progressed quickly. by 9pm it was 103.7 By 11:00pm my fever was 105.4. By midnight it was 105.9 I took Vicks NyQuil because it was the only pain med that had Tylenol in it. Fever reduced to 105.4 by 2:30 am fever was at 104.5 and I felt safe to try and sleep and not die. A nurse friend was telling me to go to the emergency room. I applied and Ice pack to my splitting headache and eyeballs felt like they were going to pop out. also Icepack to neck. ate a popsicle. I hydrated emencely before the shot and All day with the shot. I kept moving my arm and it was fine after a few hours. THE FEVER SITUATION WAS QUITE FEARFUL AND STRESSFULL. My throat felt a "little" tightening. I swallowed every few minutes to make sure it did not progress. I had Benadryl on hand just in case. I slept from 3:00am until 9:30 am. My morning fever was between 103.7 and 104.5 It was 102.4 at 3:00pm it is 8:45 pm and my temp is 202.2 now. head ache is at 50% of yesterday.
65 2021-04-09 weakness Within minutes of the vaccine shot, began to sweat and was dizzy. Immediate attention by health car... Read more
Within minutes of the vaccine shot, began to sweat and was dizzy. Immediate attention by health care professionals at site. Blood pressure dropped severely. Laid on cot to recover. Left after approximately 50 minutes. Driving home, some tongue swelling, went directly to Hospital ER, where they proscribed fluids, Benedryl and observation. Arrived home around 2:30. 24 hours later, still having dizziness and some tongue swelling, headache and weakness.
65 2021-04-11 weakness Fever 101.3 chills, splitting headache, wekness, sore throat, dizziness, slight swelling of throat a... Read more
Fever 101.3 chills, splitting headache, wekness, sore throat, dizziness, slight swelling of throat and tongue. Took two benadryls and four ibuprofens.
65 2021-04-11 weakness 3/18 vaccination 3/19 4am woke up I felt sick I had a HA, Nauseas, dizzy, hard to stand, hard to ke... Read more
3/18 vaccination 3/19 4am woke up I felt sick I had a HA, Nauseas, dizzy, hard to stand, hard to keep eyes open to even go to the bathroom. I tried to go back to sleep. When I woke up, I took it easy. I did get the chills and sweats thru the day; skin turns really red (MCAS). That symptoms still comes and goes. The chills, regulating body temperature, has flared back up after being dormant for years. 3/30 I saw MD. She wanted to defer for 4-6 weeks after vaccination to see if symptoms were still persisting or leveling out. I have since canceled every sort of appt since then as I don't have the energy. *I am on the very tail end of an opioid withdrawal; tramadol. I have taken for 6 years, 400 mg weened down to 100 mg this last year, down to 12.5.
65 2021-04-12 numbness Pt received the Johnson and Johnson shot on Sunday. On monday, she had the "worst headache ever", in... Read more
Pt received the Johnson and Johnson shot on Sunday. On monday, she had the "worst headache ever", intermittent chest pain, and left sided facial numbness. Symptoms continue today, was told to present to the ER by her PCP.
65 2021-04-12 pain in extremity Experienced very sore calf within 2 weeks of vaccine but thought it was from snowshoeing. Then on Ap... Read more
Experienced very sore calf within 2 weeks of vaccine but thought it was from snowshoeing. Then on April 8 I developed vein inflammation in two areas. An ultrasound on April13 showed two blood clots. One superficial and one dvt
65 2021-04-12 pain in extremity Right lower extremity pain, redness/discoloration , and swelling.
65 2021-04-12 pain in extremity On April 7 (six days after the vaccine) my mother experience a sharp pain on her left arm, radiating... Read more
On April 7 (six days after the vaccine) my mother experience a sharp pain on her left arm, radiating to her neck, back and finally chest. We went to emergency department, and she had EKG, CT Scan, X-Rays, MRI and blood work and could not find anything. She was discharge but the pain didnt go away. She is still in pain but less than before.
65 2021-04-12 tremor, feeling cold, muscle spasms When I was receiving the shot on 4-6-21 it was very painful I could feel it all the way to my elbow ... Read more
When I was receiving the shot on 4-6-21 it was very painful I could feel it all the way to my elbow and About 2 AM on 4-7-21 I tarted feeling very very cold and trembling and delusional I could not recognize my home I had muscle spams on both legs and fever finally got up and took some Advil put on extra PJ's and socks and turn on the heater finally fell asleep about 4 AM about 8 AM on 4-7-21 woke up with a headache and very very tired lot of pain on my left arm so stayed home from work and rested on 4-8-21 came to work at 7 AM and was seeing everything blurry as the day progressed it got worse finally went home about 3 PM took more Advil and rested some more my left arm hurt me for 6 days and I felt very tired and a bit confused I did not call my doctor or any one at Health Department I just took care of myself
65 2021-04-13 feeling hot, tremor ITCHINESS; HIVES; FEVER; HOT; SWEATY; LIGHT HEADED; SHAKY; NAUSEA; This spontaneous report received ... Read more
ITCHINESS; HIVES; FEVER; HOT; SWEATY; LIGHT HEADED; SHAKY; NAUSEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced shaky. On 05-APR-2021, the subject experienced nausea. On 05-APR-2021 14:30, the subject experienced hot. On 05-APR-2021 14:30, the subject experienced sweaty. On 05-APR-2021 14:30, the subject experienced light headed. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9 F. On 08-APR-2021, the subject experienced itchiness. On 08-APR-2021, the subject experienced hives. Treatment medications included: diphenhydramine hydrochloride, loratadine, and prednisone. The patient recovered from hot, sweaty, light headed, shaky, and nausea on 05-APR-2021, and fever on 06-APR-2021, and had not recovered from itchiness, and hives. This report was non-serious.
65 2021-04-13 migraine Migraines, lung infection, blood clots, pain in lungs, shortness of breath.
65 2021-04-13 nerve pain, flushing SHINGLES-lesions developed on the left side of my forehead w/ nerve pain to my head and ear. Itchine... Read more
SHINGLES-lesions developed on the left side of my forehead w/ nerve pain to my head and ear. Itchiness to my scalp with left top pf head very warm to touch. Flush feeling to entire face. Woke up with this the Saturday morning after the injection and lacey rash over entire body w/ rash gone Sunday morning with lesions to my left forehead still visible. Lesions began to weep on Monday morning.
65 2021-04-13 tingling anaphylaxis, severe face swelling, throat closing, arm swelling, headaches, ongoing dizziness, equil... Read more
anaphylaxis, severe face swelling, throat closing, arm swelling, headaches, ongoing dizziness, equilibreum issues, aches, stomach issues, rash on face, neck, torso and both legs, nausea ongoing, tingling sensations. 8 benadryl in first 30 min. kept me there for one hour - almost two weeks out and still not fully resolved (very dizzy, severe headaches, some swelling remains)
65 2021-04-14 numbness, pain in extremity numbness and pain in left leg; abdominal pain
65 2021-04-14 tingling DIZZINESS, NAUSEA, TINGLING/ NUMBNESS OF LIPS AND MOUTH AND BODY, FELT UNSTEADY ON HER FEET
65 2021-04-14 unresponsive to stimuli, inability to speak 3/28/2021 at 6:00 a.m. patient reported chest pain to a family member. He arrived at her home at 6:1... Read more
3/28/2021 at 6:00 a.m. patient reported chest pain to a family member. He arrived at her home at 6:15 and found her slumped to the right in her chair, unresponsive. Patient was taken to our facility via EMS. On arrival, patient could open her eyes but could not talk or move her extremities. She was treated with alteplase 100 mg and flown to a trauma center. She was released on 4/2 and is currently receiving rehabilitation services in our facility; she is expected to return home in 4-5 days.
65 2021-04-15 migraine Got shot at 10:15am. Felt tired mid-afternoon. Got chills early evening. Went to bed with low grade ... Read more
Got shot at 10:15am. Felt tired mid-afternoon. Got chills early evening. Went to bed with low grade fever, which ramped up quickly. Fever-topped out at 101.4 by 3:00am, body aches, repeated vomiting, repeated massive diarrhea, severe headache -crushing, squeezing vise (in the top 10 worst of my life -including migraines!), bright pink/red fingers and toes, racing uneven heartbeat. Couldn't sleep. In tears from headache pain. In desperation took an 800mg Ibuprofen pill at 4:00am. Finally got to sleep. Woke up 5 hours later. Fever mostly gone. Other symptoms receding, except headache. Took 2 aspirin at noon. Still have minor headache. Yuck!
65 2021-04-15 night sweats Severe Joint and muscle aches, fever, chills, loss of appetite, night sweats, severe headache, extre... Read more
Severe Joint and muscle aches, fever, chills, loss of appetite, night sweats, severe headache, extreme fatigue. Symptoms started 8 hours after injection and persisted for 3 days. Took Tylenol as needed for fever and pain. Extreme fatigue kept me immobilized for those 3 days.
65 2021-04-15 pain in extremity Taken by ambulance from home to ER on Sunday, March 21, around 7:30 pm. Symptoms were severe head an... Read more
Taken by ambulance from home to ER on Sunday, March 21, around 7:30 pm. Symptoms were severe head and leg pain, vomiting and diarrhea. X-rays and blood work taken. Given pain medication and fluids. Dr in ER said it could be a virus. Discharged at midnight Monday 22. Followed up with my primary.
65 2021-04-15 tingling, numbness POOR CIRCULATION (IN FINGERS, FOOT, ANKLES, ARMS); BLOTCHY RASH WHICH GOES UP THE ANKLE AND LEG ABOU... Read more
POOR CIRCULATION (IN FINGERS, FOOT, ANKLES, ARMS); BLOTCHY RASH WHICH GOES UP THE ANKLE AND LEG ABOUT 2 INCHES; TINGLING DOWN LEFT ARM AND IN FINGERS; LEFT ARM AND FINGERS ARE NUMB; RIGHT ANKLE SWELLS AT NIGHT; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included parkinson's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced poor circulation (in fingers, foot, ankles, arms). On 26-MAR-2021, the subject experienced blotchy rash which goes up the ankle and leg about 2 inches. On 26-MAR-2021, the subject experienced tingling down left arm and in fingers. On 26-MAR-2021, the subject experienced left arm and fingers are numb. On 26-MAR-2021, the subject experienced right ankle swells at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from poor circulation (in fingers, foot, ankles, arms), blotchy rash which goes up the ankle and leg about 2 inches, tingling down left arm and in fingers, left arm and fingers are numb, and right ankle swells at night. This report was non-serious.
65 2021-04-15 tremor Evening of Day 1, shaking chills, fever (100), headache. Went to bed at 9:00, woke at 3am with sever... Read more
Evening of Day 1, shaking chills, fever (100), headache. Went to bed at 9:00, woke at 3am with severe "swelling" I felt like my brain was too big for my skull, my entire face felt swollen. Joint aches, muscle aches, nausea. Nausea has been intermittent thru day 5. Headache continues but not as severe. I still wake up with it every day (this is now day 5). Diarrhea began on Day 3 (watery, every 1/2 hour for 4 hours). fever subsided and returned on Day 3 (100). no fever since but muscle aches, headache and joint aches continue.
65 2021-04-16 concussion Suddenly blacked out and fell; mild concussion and soft issue injuries to right side of body; extrem... Read more
Suddenly blacked out and fell; mild concussion and soft issue injuries to right side of body; extreme fatigue and nausea.
65 2021-04-17 pain in extremity ITCHINESS; REDNESS OF ARM; SORENESS OF THE ARM; SWELLING OF THE ARM; TIREDNESS; This spontaneous rep... Read more
ITCHINESS; REDNESS OF ARM; SORENESS OF THE ARM; SWELLING OF THE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid problem, mild asthma, sinusitis, seasonal allergies, alcohol use, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug use and the patient had bad allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) .5 ml, administered on 04-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced soreness of the arm. On 04-MAR-2021, the subject experienced swelling of the arm. On 04-MAR-2021, the subject experienced tiredness. On 04-MAR-2021, the subject experienced redness of arm. On 05-MAR-2021, the subject experienced itchiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness of the arm, swelling of the arm, tiredness, and itchiness, and the outcome of redness of arm was not reported. This report was non-serious.
65 2021-04-18 weakness, pain in extremity, slurring Patient had slurred speech, headache, pain in the thigh muscles, bloody nose, lost strength in the a... Read more
Patient had slurred speech, headache, pain in the thigh muscles, bloody nose, lost strength in the arms, hands and legs, could not chew or swallow. She was diagnosed with Guillian Barre Syndrome and hospitalized from 04/04/2021-04/18/2021.
65 2021-04-18 muscle twitching BODY TWITCHING; HEADACHE; CHILLS; BODY ACHE; UPSET STOMACH; This spontaneous report received from a ... Read more
BODY TWITCHING; HEADACHE; CHILLS; BODY ACHE; UPSET STOMACH; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug or non drug allergy. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and 1805018 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced body ache. On 12-MAR-2021, the subject experienced upset stomach. On 13-MAR-2021, the subject experienced body twitching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and upset stomach on 13-MAR-2021, and had not recovered from headache, body ache, and body twitching. This report was non-serious.
65 2021-04-18 tingling april 7, extreme skin tingling all over, only lasted that one night april 12, noticed increased tinn... Read more
april 7, extreme skin tingling all over, only lasted that one night april 12, noticed increased tinnitis, I already had it and it is now louder
65 2021-04-19 numbness pt says one of her toes on her left foot went completely number. Within a couple of days she starte... Read more
pt says one of her toes on her left foot went completely number. Within a couple of days she started swelling between her left big toe and the toe next to it. Her entire left foot started swelling and then her leg started swelling. She went via ambulance to ER. They did an US of her leg and found 2 blood clots in the back of calve. She was given a RX for blood thinner. She went to 3 pharmacies and could not find it so she went home. She went home and then her right foot swelling as well. She went back via ambulance to ER. She was given blood thinner injection, and IV and took blood work. Pt was admitted where she stayed for 5 days. She was released and prescribed Eliquis. She has to take 20 mg a day for first week and then 10mg a day the following week for 3 months. She still has constant pain and her left foot continues to swell. Pt will have to have another US in 3 months.
65 2021-04-19 migraine Very High Fever followed by aches and pains with congestion then a severe headache like a migraine a... Read more
Very High Fever followed by aches and pains with congestion then a severe headache like a migraine and ending with 3-4 days of diarrhea
65 2021-04-19 pain in extremity around 1 week before appt (4/16/21) started noticing pain in underside of right arm, gradually wor... Read more
around 1 week before appt (4/16/21) started noticing pain in underside of right arm, gradually worsened and moved into axillae area and in to right chest wall.
65 2021-04-20 brain damage Patient admitted 4/12/21 with fatigue and abdominal pain. Found to have UTI but no definite sepsis,... Read more
Patient admitted 4/12/21 with fatigue and abdominal pain. Found to have UTI but no definite sepsis, and acute renal failure. Treated with iv antibiotics and iv fluids. Over next 48 hours developed worsening encephalopathy and thrombocytopenia. MRI/MRA/MRV showed no acute findings. Hyperammonemia noted, with no known Hx of cirrhosis; US did not show portal vein or hepatic vein thrombosis. Encephalopathy worsened, no clear etiology; EEG just showed generalized encephalopathy. Renal function worsened. Patient became obtunded and was intubated 4/16/19. Platelet nadir of 31k. Dialysis started. Left common femoral DVT developed. Patient had DIC type picture. Respiratory failure worsened, hypotension developed, patient passed away 4/20/21. No clear etiology of encephalopathy and thrombocytopenia identified, unclear if related to J&J vaccine received 2 weeks prior.
65 2021-04-21 pain in extremity FELT TIRED; FLU-LIKE SYMPTOMS (CHILLS AND HEADACHE); SORE LEFT ARM; BOTH HANDS HURTING AS WELL; This... Read more
FELT TIRED; FLU-LIKE SYMPTOMS (CHILLS AND HEADACHE); SORE LEFT ARM; BOTH HANDS HURTING AS WELL; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced flu-like symptoms (chills and headache). On 12-APR-2021, the subject experienced sore left arm. On 12-APR-2021, the subject experienced both hands hurting as well. On 13-APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms (chills and headache), sore left arm, and both hands hurting as well on 13-APR-2021, and felt tired on 14-APR-2021. This report was non-serious.
65 2021-04-21 pain in extremity ACHY; ARM SORENESS; MINIMAL CALF PAIN; SPLIT SECOND FEELINGS OF NAUSEA; TIRED; This spontaneous repo... Read more
ACHY; ARM SORENESS; MINIMAL CALF PAIN; SPLIT SECOND FEELINGS OF NAUSEA; TIRED; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood transfusion, and concurrent conditions included toxic shock syndrome, and neutropenia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced achy. On 09-APR-2021, the subject experienced arm soreness. On 09-APR-2021, the subject experienced minimal calf pain. On 09-APR-2021, the subject experienced split second feelings of nausea. On 09-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, and the outcome of arm soreness, split second feelings of nausea, achy and minimal calf pain was not reported. This report was non-serious.
65 2021-04-21 pain in extremity I currently have swelling in my hands, pain in my vaccinated arm, bone pain, a bump in my hand like ... Read more
I currently have swelling in my hands, pain in my vaccinated arm, bone pain, a bump in my hand like thrombi, burning sensation in my stomach, taste of blood in my throat, leg and joint pain. After I was vaccinated.
65 2021-04-22 breast pain, pain in extremity DIARRHEA; THREW UP; NAUSEATED; HEADACHE; LUNG PAIN (FELT LIKE LUNGS GOING TO EXPLODE); LEFT ARM PAIN... Read more
DIARRHEA; THREW UP; NAUSEATED; HEADACHE; LUNG PAIN (FELT LIKE LUNGS GOING TO EXPLODE); LEFT ARM PAIN; FATIGUE AND FELT TIRED; LETHARGY; SICK; PAIN DOWN FROM LEFT BREAST TO ELBOW; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced pain down from left breast to elbow. On 07-APR-2021, the subject experienced lethargy. On 07-APR-2021, the subject experienced sick. On 07-APR-2021, the subject experienced left arm pain. On 07-APR-2021, the subject experienced fatigue and felt tired. On 08-APR-2021, the subject experienced lung pain (felt like lungs going to explode). On 08-APR-2021, the subject experienced nauseated. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced threw up. On 11-APR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: oxycodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from threw up, and diarrhea, had not recovered from fatigue and felt tired, lung pain (felt like lungs going to explode), nauseated, left arm pain, lethargy, headache, and pain down from left breast to elbow, and the outcome of sick was not reported. This report was non-serious.; Sender's Comments: V0: MAC comment not required for non serious cases as per standard protocol
65 2021-04-22 numbness, pain in extremity, tingling Report pain of the left upper arm. Tingling of left arm, hand and fingers. Numbness in fingerti... Read more
Report pain of the left upper arm. Tingling of left arm, hand and fingers. Numbness in fingertips of left hand began 2 weeks post vaccination. Treatment: None Outcome: No improvement symptom are getting worst. Continues to work does not interfere with ADLs. Advise to follow-up with PCP.
65 2021-04-22 muscle spasms Patient has leg cramps starting on Monday, April 19th. She went to the hospital at later date. Docto... Read more
Patient has leg cramps starting on Monday, April 19th. She went to the hospital at later date. Doctor diagnosed her with leg clot.
65 2021-04-23 weakness, numbness NUMBNESS IN HANDS, FINGERS AND FACE; CONGESTION; SORE THROAT; DIZZINESS; CHILLS; WEAKNESS; FEVER; FA... Read more
NUMBNESS IN HANDS, FINGERS AND FACE; CONGESTION; SORE THROAT; DIZZINESS; CHILLS; WEAKNESS; FEVER; FATIGUE; NAUSEA; HEADACHE; MUSCLE PAIN IN BACK; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced numbness in hands, fingers and face. On 09-MAR-2021, the subject experienced congestion. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced weakness. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced muscle pain in back. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, weakness, fever, and headache on 10-MAR-2021, and had not recovered from fatigue, nausea, muscle pain in back, numbness in hands, fingers and face, congestion, and sore throat. This report was non-serious.
65 2021-04-23 tingling, numbness 4 days after vaccine couldn't grasp with hands, numbness, tingle throughout arms and hands, loss of ... Read more
4 days after vaccine couldn't grasp with hands, numbness, tingle throughout arms and hands, loss of balance, now uses a walker, can not sit up alone. Had to have emergency surgery ACDF of C4/5 and C5/6
65 2021-04-25 pain in extremity Right arm sharp pains began within 1 week of receipt of the vaccine. Pain present with laying on the... Read more
Right arm sharp pains began within 1 week of receipt of the vaccine. Pain present with laying on the arm. Right arm pain persisted with swelling presenting on 4-26-21.
65 2021-04-26 pain in extremity HEADACHE; RED SPOTS / RASH IN LEFT ARM; KNOT/LUMP IN LEFT LEG; SWOLLEN LEFT ARM; TENDER LEFT ARM; Th... Read more
HEADACHE; RED SPOTS / RASH IN LEFT ARM; KNOT/LUMP IN LEFT LEG; SWOLLEN LEFT ARM; TENDER LEFT ARM; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included deteriorating disc disease (c4 and c5 in spine), pain in hand, tingling in hand, neuropathy, and varicose veins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20/JUN/2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, fosinopril, ibuprofen, metformin, and simvastatin. On APR-2021, the subject experienced knot/lump in left leg. On APR-2021, the subject experienced swollen left arm. On APR-2021, the subject experienced tender left arm. On 19-APR-2021, the subject experienced red spots / rash in left arm. On 20-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knot/lump in left leg, tender left arm, red spots / rash in left arm, and headache on APR-2021, and had not recovered from swollen left arm. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
65 2021-04-26 sciatica At the time, I had very mild injection site pain and warmth on the site. For a couple of days. On Mo... Read more
At the time, I had very mild injection site pain and warmth on the site. For a couple of days. On Monday, the 15th, I had the worst flare-up of sciatica that I have ever had in my life. Left leg - it had a tremendous swelling. It was crippling. I am still using a pain. I cried because the pain was so horrific. I was able to get into the doctor early on Tuesday - prescribed Prednisone; hydrocodone; muscle relaxer. None of which touched the pain. I was unable to sleep for three days. I slept upright in a chair. I used an office chair as a wheel chair. I wasn't able to lay down. I've improved but I still can't walk to the mailbox - could walk down there - two houses down but couldn't get back. I am using a cane still. I have to elevate leg on a recliner to sleep so it will help with the continued swelling. There was nothing I did that triggered it.
65 2021-04-27 pain in extremity 4/19/2021: Woke up in the middle of the night with an achy arm. Had this for a week. Went to chiropr... Read more
4/19/2021: Woke up in the middle of the night with an achy arm. Had this for a week. Went to chiropractor as she thought it was neck trouble. Chiropractor states arm is swollen and see MD. MD sent patient for ultrasound and blood clot confirmed in right arm pit. Patient started on eliquis.
65 2021-04-27 pain in extremity ITCHINESS; REDNESS OF ARM; SWELLING OF THE ARM; SORENESS OF THE ARM; TIREDNESS; This spontaneous rep... Read more
ITCHINESS; REDNESS OF ARM; SWELLING OF THE ARM; SORENESS OF THE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid, mild asthma, sinusitis, seasonal allergies, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no known drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for thyroid. On 04-MAR-2021, the subject experienced redness of arm. On 04-MAR-2021, the subject experienced swelling of the arm. On 04-MAR-2021, the subject experienced soreness of the arm. On 04-MAR-2021, the subject experienced tiredness. On 05-MAR-2021, the subject experienced itchiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of the arm, soreness of the arm, and tiredness on 17-MAR-2021, had not recovered from itchiness, and the outcome of redness of arm was not reported. This report was non-serious.
65 2021-05-01 impaired body coordination, hypersensitivity of all senses, tenderness, tension headache See below
65 2021-05-03 numbness About 4 and a half weeks after getting the J&J vaccine, I began to experience marked symptoms: dizzi... Read more
About 4 and a half weeks after getting the J&J vaccine, I began to experience marked symptoms: dizziness and disorientation,, balance problems, bilateral numbness in hands, feet and tip of tongue, awareness of left side of brain, intermittent mild nausea (likely related to dizziness). These symptoms had a sudden onset. I am normally very healthy and active so these unusual symptoms without any illness were quite a departure from my normal health. They have, to date, persisted continually since onset over the past 3 weeks. They are very concerning. Last night I went to the ER to be seen since I could not get an appt. with a neurologist for several months and I am concerned about my sudden change in health status.
65 2021-05-05 weakness Extreme dizziness- ongoing since injection. Weakness, fatigue, blood results show increase in calciu... Read more
Extreme dizziness- ongoing since injection. Weakness, fatigue, blood results show increase in calcium levels and albumin levels. Urgent Referral to ENT in process.
65 2021-05-09 pain in extremity pt experienced flu like symptoms beginning 6-7 hours after receiving the vaccine. She reported heada... Read more
pt experienced flu like symptoms beginning 6-7 hours after receiving the vaccine. She reported headache, body aches, chills, sore arm. Significant bruising the size of a tennis ball appeared 18 hours later around the area of injection and persisted for 10 days.
65 2021-05-10 trigeminal neuralgia This was the worsening of a chronic condition - my amount of Carbamazepine I was taking was increase... Read more
This was the worsening of a chronic condition - my amount of Carbamazepine I was taking was increased. That failed to resolve the issue so another medication of Baclofen was added. It has helped with my symptoms. I have surgery planned now for this. May 28th will be the date for that.
65 2021-05-11 weakness FELT LIKE LEGS WILL BUCKLE UNDER HER WHEN GOING TO RESTROOM; HIVES; ITCHING; INSOMNIA; DOES NOT FEE... Read more
FELT LIKE LEGS WILL BUCKLE UNDER HER WHEN GOING TO RESTROOM; HIVES; ITCHING; INSOMNIA; DOES NOT FEEL HERSELF; ANXIETY; DRY MOUTH DESPITE DRINKING A LOT OF WATER AS DIRECTED; WEAKNESS; 24 HOUR FLU; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207a21a, and expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced 24 hour flu. On 06-MAY-2021, the subject experienced dry mouth despite drinking a lot of water as directed. On 06-MAY-2021, the subject experienced weakness. On 07-MAY-2021, the subject experienced itching. On 07-MAY-2021, the subject experienced insomnia. On 07-MAY-2021, the subject experienced does not feel herself. On 07-MAY-2021, the subject experienced anxiety. On 07-MAY-2021, the subject experienced hives. On 08-MAY-2021, the subject experienced felt like legs will buckle under her when going to restroom. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 24 hour flu on 08-MAY-2021, and insomnia, was recovering from hives, and felt like legs will buckle under her when going to restroom, and had not recovered from itching, anxiety, does not feel herself, dry mouth despite drinking a lot of water as directed, and weakness. This report was non-serious.
65 2021-05-12 nerve pain No problems the remainder of day of injection. Next morning upon awakening, I was very groggy and un... Read more
No problems the remainder of day of injection. Next morning upon awakening, I was very groggy and unable to stay awake. I slept 4 hours past my normal time for getting up. I had no balance and would stagger when standing. My entire body was in muscle and nerve pain. Even my skin hurt. I took 300 mg of Gabapentine which eased my pain. I continued to be off balance the remainder of the day, however, by the end of the day I was much better. I took several 1 hour naps throughout the day.
65 2021-05-18 unresponsive to stimuli, seizure Patient was non-communicative but sitting still in the chair. Appeared to be in a mild type of seiz... Read more
Patient was non-communicative but sitting still in the chair. Appeared to be in a mild type of seizer temporarily. After a few minutes was able to communicate and was feeling better.
65 2021-05-20 feeling hot She started itching, got hot, said her tongue felt funny. I sat with her asked her if was ok breAThi... Read more
She started itching, got hot, said her tongue felt funny. I sat with her asked her if was ok breAThing short of breath, she said no. I ASKED IF SHE WANTED A BENADRYL AND SHE SAID NO. MY TECH WAS AN EMT AND CAME OUT WHILE I WENT TO GET BLOOD PRESSURE CUFF, WE WATCHED HER AND SHE STARTED GETTING ITCHIER BUT BLOOD PRESSURE WAS FINE. WE CALLED EMS . SHE WAS RESPONSIVE, DIZZY, AND ALERT WHEN SHE LEFT WITH EMS.
65 2021-05-20 pain in extremity, muscle spasms -Severe abdominal pain, projectile vomiting, severe diarrhea that lasted for 3 days. - spasms and p... Read more
-Severe abdominal pain, projectile vomiting, severe diarrhea that lasted for 3 days. - spasms and pain in legs
65 2021-05-20 pain in extremity, tingling On April 1st through April 4th, it first started with extreme fatigue. On April 5th, my entire left ... Read more
On April 1st through April 4th, it first started with extreme fatigue. On April 5th, my entire left side of my neck, shoulder, upper back, and arm became tight and racked with pain. My whole left arm had felt like pins and needles, which progressed to my fingertips. I went to the chiropractor on April 6th, 8th, and 10th. On April 12th, I went to Dr. and he prescribed me steroids and muscle relaxers. It took a month to feel like I was at 99% again, I still have tingling in my left hand.
65 2021-05-23 pain in extremity Patient presented to ED on 5/12 with complaints on gradually worsening left leg swelling and pain... Read more
Patient presented to ED on 5/12 with complaints on gradually worsening left leg swelling and pain for 3 days, no with difficulty ambulating. Patient reports she received the J&J vaccine 5 weeks prior.
65 2021-05-24 tremor Systemic: syncope-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Patie... Read more
Systemic: syncope-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Patient sat down for more than 15mins after receiving vaccine then walk out side to wait for pick up. While waiting, she got syncope and fell down on the side walk, got a bump on the leftside of her forehead. Pt complained of nausea. She felt better after given some water. She refused to call 911. Patient came back inside and continue waiting for 45 mins when her pick up arrived, she stated feeling better and wanting to leave to go back to her hotel
65 2021-05-25 pain in extremity pt stated about 4 hours after taking the vax she had a terrible headache. pt laid down but when she... Read more
pt stated about 4 hours after taking the vax she had a terrible headache. pt laid down but when she got up she had very sharp pains shooting from her toes up to her legs. pt said she had a stabbing pain in her left mid thigh. This episode lasted about 15 minutes. the next day she went to a routine exam but her PCP did not seem to think there was anything to worry about. pt had to have blood test 10 days later. She stated she was so tired she could barely get to the lab to get the test. The following weekend on 5/17/2021 she started having SOB and a coughing spell. On 5/19/21 she called to make an appt w/ PCP on 5/21/21. She saw a different physician and she was ordered a D-Dimer test. On 5/22/21 the pt got a phone call stating she needed to get to an Emergency Room since the lab test proved she had a blood clot. She went to ER. They did a US Doppler and CT of lungs. She had 2 pulmonary thrombosis. One in left lung and one in right lung. She had one DVT in left calf. Pt was admitted. She was given heparin IV for 3 days. She was then put on Xarelto and discharged on 5/25/2021. she has to take Xarelto for 90 days and scheduled to have another US on 7/19/2021 to see if the clots are dissolved.
65 2021-05-26 weakness feeling light headed, nausea, some coughing tightness in chest, some loose stool, lower back ache, w... Read more
feeling light headed, nausea, some coughing tightness in chest, some loose stool, lower back ache, weakness, lack of sleep the first night. ate chicken noodle soup, tylenol PM, slept, drank white tea with peppermint tea, sucked, on Ricola drops and EmergenC drops
65 2021-05-26 tenderness Immediate extremely strong metallic taste in mouth. Tongue and lips a little puffy. Very inflamed l... Read more
Immediate extremely strong metallic taste in mouth. Tongue and lips a little puffy. Very inflamed lymph nodes in neck. Metallic taste went to gums, and I could feel the metal taste scallop across my teeth, from left to right. Felt a sweaty sensation on top of head, like I had a bowl on top of my head. Metallic taste started going down my throat. Soft palate swollen causing gagging due to uvula touching my tongue. Could feel the sensation on my head inching its way down my head. It stopped at the hairline above my ears, which made me think that I was getting in feeling in my hair follicles and not a sweaty sensation. Stayed 70 minutes at site. Metallic taste mostly gone. I was told to pick up some Benedryl. As soon as I took it I felt a strong pounding in my ears. When eating dinner I could feel a slight constriction while swallowing. The next morning the lymph nodes in my armpits were extremely sore. Neck lymph nodes stopped being sore Saturday, but are still a little swollen. Lymph nodes in arm pits were better on Sunday, but are still sore if pushed on.
65 2021-05-27 tremor 1st 24 hours, the expected chills, fever, shakes, severe headache, muscle aches, N&V. After that, pr... Read more
1st 24 hours, the expected chills, fever, shakes, severe headache, muscle aches, N&V. After that, profound fatigue, disordered taste, nausea, for one week. After that, exhaustion continued, with any mild to moderate activity causing return of chills, nausea, and headache. This lasted over FOUR WEEKS and began to resolve only with naturopathic treatment.
65 2021-05-29 pain in extremity Chills, upset stomach, store leg muscles, vomiting, extreme fatigue
65 2021-05-29 tremor, flushing, unresponsive to stimuli Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Letharg... Read more
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Mild, Additional Details: LOSS OF URINARY CONTROL
65 2021-05-31 pain in extremity SUBACUTE PULMONARY EMBOLISM IN LEFT AND RIGHT LUNG; DVT IN LEFT CALF; UNABLE TO DRIVE; EXTREME EXHAU... Read more
SUBACUTE PULMONARY EMBOLISM IN LEFT AND RIGHT LUNG; DVT IN LEFT CALF; UNABLE TO DRIVE; EXTREME EXHAUSTION; HEADACHE; SHARP SHOOTING PAIN IN RIGHT LEG; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known previous medical conditions and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, once total administered on 06-APR-2021 15:00 in Left Arm for prophylactic vaccination. Concomitant medications included amlodipine, hydrochlorothiazide and losartan for which indication was not provided. On 06-APR-2021, the patient experienced headache while driving back to home and was not sure if it was due to vaccine or traffic conditions. At 18:30, patient got up to walk across the room and felt a strong sharp pain in her right and left leg described as incredible cramping type of pain which her husband had to help sit down to a chair. Patient states that although the pain was in both legs, the left leg felt as though someone had took a knife to her thigh, the pain lasted approximately 15 minutes. On 07-Apr-2021, patient states that she went for a routine doctors visit to her family care physician who wrote her a prescription for routine blood work. On 14-Apr-2021, patient went to get the blood work done and states at this time, she felt extremely exhausted and that due to a bloodwork mix up which required her to drive back to the lab, she was not able to drive back so her husband had to drive her. Around 17-Apr-2021 to 18-Apr-2021 patient had to chase the dog and found that she couldn't catch her breath and that she started coughing. Her daughter who happened to be there asked her why she was coughing and thought that it was not normal and that she should contact her doctor.On 19-Apr-2021, patient called the doctor. On 21-Apr-2021 patient saw the doctor and during examination, patient was instructed to run a D-Dimer test to rule out blood clots. On 22-Apr-2021, doctor stated patient to go to the Emergency Room as the result for the D-Dimer test came positive. The patient was immediately hospitalized where Doppler and CT scan was performed on her and was diagnosed with Deep Vein Thrombosis and Pulmonary Embolism on both the lungs. Patient mentioned that she was treated with Heparin drip from 22-Apr-2021 to 24-Apr-2021 and then she was given Xarelto. On 25-Apr-2021, the patient was discharged from the hospital after 4 days of hospitalization. Patient reports that she was still experiencing extreme exhaustion and that the pulmonologist states that this is the normal course of blood clots and it could take anywhere from 60-90 days for the body to clear up the blood clots. She states she still has bouts of shortness of breath but showing signs of improvement. Patient stated that she was scheduled for another Doppler on 19-Jun-2021 which was recommended by her primary care physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp shooting pain in right leg on 06-APR-2021 ,had not recovered from extreme exhaustion, and the outcome of pulmonary embolism in left and right lung, dvt in left calf, headache and unable to drive was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210550248-COVID-19 VACCINE AD26.COV2.S, The case concerns with a Caucasian female. Subacute pulmonary embolism in left and right lung, deep vein thrombosis in left calf. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
65 2021-06-01 weakness Little brown, purple, and red spots (lots of red spots) allover the body. Little blood vessels brok... Read more
Little brown, purple, and red spots (lots of red spots) allover the body. Little blood vessels broke. Pt has not been feeling good since receiving the shot. Pt did not hit her legs but had a very painful legs and when she looked down she had blood vessels broking. Has red blood vessels on face and legs only. Pt has been feeling tired and no energy and was not able to work some days.
65 2021-06-28 pain in extremity, tingling DISCOMFORT IN UNDERSIDE OF RIB; DISCOMFORT IN LEFT ARM; NAUSEA; HEADACHE; TINGLING DOWN TO FINGERNAI... Read more
DISCOMFORT IN UNDERSIDE OF RIB; DISCOMFORT IN LEFT ARM; NAUSEA; HEADACHE; TINGLING DOWN TO FINGERNAILS; PULLED A MUSCLE IN BACK; DIZZINESS, LIGHTHEADEDNESS UPON STANDING; DRY MOUTH; ARM HURTS WHEN STRETCHED; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included narcolepsy, and cluster headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. Concomitant medications included verapamil for cluster headache. On JUN-2021, the subject experienced tingling down to fingernails. On JUN-2021, the subject experienced pulled a muscle in back. On JUN-2021, the subject experienced dizziness, lightheadedness upon standing. On JUN-2021, the subject experienced dry mouth. On JUN-2021, the subject experienced arm hurts when stretched. On 21-JUN-2021, the subject experienced discomfort in underside of rib. On 21-JUN-2021, the subject experienced discomfort in left arm. On 21-JUN-2021, the subject experienced nausea. On 21-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the discomfort in left arm, dizziness, lightheadedness upon standing, dry mouth, nausea, headache, pulled a muscle in back, arm hurts when stretched, discomfort in underside of rib and tingling down to fingernails was not reported. This report was non-serious.
65 2021-06-30 coordination abnormal I had a number of strokes between April and May. As many as 9 of them. Memorial Day, 31st, I went to... Read more
I had a number of strokes between April and May. As many as 9 of them. Memorial Day, 31st, I went to the hospital ER at 9:00PM. I had a PFO, which is something like Patent Forman Ovale, heart condition, hole in atrium of heart that causes the blood to go from heart to brain. Blood clots to the brain, venous blood gets into the arterial blood. The clots could have formed everywhere but they go straight up the brain. They went through an artery and put a mesh screen over my heart opening and eventually it will help that. It was done through an artery, 15 minute process. I left the hospital the following Saturday. This week (two days ago) I have really bad tinnitus starting in both ears. My hearing is quite disrupted. I don't know how serious it is right now. I am being treated with an anti-cholesterol drug (Lipitor) and aspirin. I still have a little bit of cognitive impairment and physical fatigue. My coordination is messed up. Physical therapy starts the 15th and Speech therapy on the 23rd. I had just gotten a job two weeks before the strokes.
65 2021-07-06 tenderness Two weeks after vaccination, developed fatigue, low platelets (30,000), pain in thorax (ribs - tende... Read more
Two weeks after vaccination, developed fatigue, low platelets (30,000), pain in thorax (ribs - tenderness/pain bilaterally, variable location - worse with standing up, not related to breathing), shortness of breath - developed epistaxis.
65 2021-07-07 burning sensation, tremor Started w/ nauseau and diarhea, shaking and chills (even in hot climate), take ibuprofen and peptobi... Read more
Started w/ nauseau and diarhea, shaking and chills (even in hot climate), take ibuprofen and peptobismalevery three hours, dreams, weird fever dreams, left leg burning, lower teeth pain, joint pain in left hand (unusual). After two weeks burning dissapeared, everything else lasted only 4 days
65 2021-07-09 feeling hot C/o shortness of breath and feeling hot momentarily after receiving the covid vaccination. States t... Read more
C/o shortness of breath and feeling hot momentarily after receiving the covid vaccination. States throat itchy but transient. Educated regarding anaphylactic reactions and airway closing. States that it was only for a minute or two that she felt something. Encouraged to wait 45 to 60 minutes to insure that she will not have further sxs. VSS: 132/70-t8 pulse and regular, 98% oximeter reading
65 2021-07-12 weakness Taking a shower and starting having severe shortness of breath, got real weak and it lasted about 45... Read more
Taking a shower and starting having severe shortness of breath, got real weak and it lasted about 45 mins. Could barely walk. Went to the ER got admitted and they couldn't find anything. She had to walk with a walker, body and joint aches. Walks very slow now, balance is off and she get lightheaded
65 2021-07-15 feeling hot Six and a half weeks previous to my vaccination (April 26) I had 2 basal cell carcinomas removed fro... Read more
Six and a half weeks previous to my vaccination (April 26) I had 2 basal cell carcinomas removed from my right lower leg; one by Mohs and one by simple excision. These were fully healed. On June 12, the day after my vaccination, both excision sites became red, hot, swollen and painful. I called Dr, the physician that performed the excisions and he prescribed Clindamycin. The sites became increasingly red and painful with purulent drainage so I was seen at my PCP for a culture which came back positive for staph aureus. I was changed to Doxycycline for 10 days and completed the full course of antibiotics. I was also seen by the Dr. and he injected the sites with a steroid to reduce the inflammation. Approximately 48 hours after completing the Doxy, the excision sites began worsening again. My PCP started me on Bactrim and I was seen again by Dr. on July 12 where he removed the surface tissue and re-injected the sites with steroid again. Both are still notable red but improving.
65 2021-07-19 pain in extremity Approximately 5-7days after Johnson/Johnson COVID 19 Vaccine, mild pain has appeared to my left arm,... Read more
Approximately 5-7days after Johnson/Johnson COVID 19 Vaccine, mild pain has appeared to my left arm, and now it?s been 2mo., that pain much much worse, and unable to move in certain position. I?m very high tolerance to pain and hope it will go away but now at times its extremely unbearable. NOT sure, this left arm pain is due to vaccine, but this pain did appeared 5-7 days after JJ injection. At first, I thought it maybe sympathy pain since the injection was received on my right arm.
66 2021-03-05 weakness After roughly 4 hours I started to get chills and body aches. I went to bed but could not get warm a... Read more
After roughly 4 hours I started to get chills and body aches. I went to bed but could not get warm and writhed in considerable distress for at least an hour. (This was the most uncomfortable I've been since induced labor before the anesthesiologist arrived for an Epidural 28+ years ago.) My temperature fell to 95 before I took acetaminophen and was able to fall asleep.. Now, at 7 hours it's 101.2 and I'm just getting the side effects I expected: weakness, a little nausea.
66 2021-03-05 pain in extremity Left arm was mildly sore, as expected. Around 10 pm Thursday, I started feeling chills. During the n... Read more
Left arm was mildly sore, as expected. Around 10 pm Thursday, I started feeling chills. During the night I felt fevers and chills alternating. Around 3 am, I was nauseous and vomited, although there wasn't much actual vomit. I vomited again around 9 am the next morning, with even less vomit, since I hadn't eaten any breakfast. I rested most of Friday and ate sparingly. Today (Saturday) I feel better.
66 2021-03-07 tremor Janssen COVID-19 Vaccine EUA Approximately six hours after administration of the vaccine, patient e... Read more
Janssen COVID-19 Vaccine EUA Approximately six hours after administration of the vaccine, patient experienced sever chills and dizziness. Unable to stop shaking, patient took temperature which registered at 95.4F and then 95.1F at 15 minutes. Patient donned flannel pants, thermal shirt, and oversized hooded sweatshirt and got in bed under flannel sheets, two doubled-over blankets, a bedspread, and quilt. A down-filled king-size pillow was placed on top of patient's torso and a space heater was turned on to highest setting. Patient reports heart seemed to be racing, but did not take BP. Unable to quell the chills, the patient continued to shake, developing very stiff shoulders, neck and back as a result. This continued until approximately 2 am. The next morning, patient's temperature was registering at 99.4F and pulse was 96, but patient did not report chills. General muscle aches and mild headache were noted. At time of this report, patient's temperature and pulse are normal (97.6F and 76 pulse).
66 2021-03-09 feeling cold extreme feeling of being cold and moderate feeling of nausea for approximately 7 hours, followed by ... Read more
extreme feeling of being cold and moderate feeling of nausea for approximately 7 hours, followed by headache for about 6 hours (treated with ibuprofen), fatigue for about 24 hours.
66 2021-03-12 tremor shaking, shooting pain, sick, throwing up, fever lasting 1 day
66 2021-03-15 tremor, pain in extremity Violent shaking and chills, 100.1 fever, muscle aches, headache, dry mouth, pain in arm, nausea but ... Read more
Violent shaking and chills, 100.1 fever, muscle aches, headache, dry mouth, pain in arm, nausea but no vomiting
66 2021-03-15 tremor light headedness, dizzy, shaking
66 2021-03-16 muscle spasms High fever of 102.8. Headache, cramping in legs, swelling in face. Lasted from 11:00 PM on 03/15/20... Read more
High fever of 102.8. Headache, cramping in legs, swelling in face. Lasted from 11:00 PM on 03/15/2021 to about 3:30 PM 03/16/2021.
66 2021-03-17 hot flush Caller c/o hot flashes twice a day since receiving the vaccine on 3/13, states that her skin feels "... Read more
Caller c/o hot flashes twice a day since receiving the vaccine on 3/13, states that her skin feels "hot", however reports no fever. Takes cool showers to feel better. No other symptoms
66 2021-03-18 feeling jittery Symptoms began little after ten hours of receiving vaccine. Symptoms included flu like symptoms of ... Read more
Symptoms began little after ten hours of receiving vaccine. Symptoms included flu like symptoms of aches , joint pain and fatigue with fever up to 101 lasting 3 1/2 days. Fever broke SUnday night 14th, approx 9:00pm. Awoke Monday the 15th light headed and fatigued but aches and fever gone. Then approximately 5 pm on Monday the 15th started having chest pain, upper right side. By midnight I was being transferred to ER for the chest pains. Released Monday morning the 16th from ER Dx. Possible chest wall inflammation; Followed up with primary care office (not my regular Dr. but with Dr. Have been experiencing internal jittering; agitated cough, upper respiratory issues (but lungs are clear.) ever since I originally had Covid.
66 2021-03-18 migraine First day: I swelled up like the Pillsbury Dough Boy. I had high blood pressure, (which I normally ... Read more
First day: I swelled up like the Pillsbury Dough Boy. I had high blood pressure, (which I normally do not have), migraine like headaches for three days and now I have a rash all over my face and arms. The rash is very itchy and annoying.
66 2021-03-18 tingling Transient ischemic attack confusion, mouth droop, delay in responses
66 2021-03-21 seizure Nausea x 4 days, concern that sx was r/t mild seizure activity.
66 2021-03-22 muscle spasms, weakness The night of the day after the vaccine was given, client started feeling an upset stomach with nause... Read more
The night of the day after the vaccine was given, client started feeling an upset stomach with nausea and cramps, felt very weak; didn't sleep that night, unable to eat d/t nausea and diarrhea started the following day. Felt better on day 3 and resolved by day 4.
66 2021-03-23 muscle twitching, weakness Flu symptoms, weak, nerve twitching, swelling, fever, chills, nausea, pain, headache, very weak pul... Read more
Flu symptoms, weak, nerve twitching, swelling, fever, chills, nausea, pain, headache, very weak pulse, heart palpitations, malaise, rigor, a horrible experience lasted 36 hours.
66 2021-03-26 pain in extremity severe upper arm muscle pain during movement-acetami/codeine 300-30mg
66 2021-03-28 pain in extremity 3-13-21 Shot, soreness in arm and knot nothing else notable except maybe mild headache 3-23 start w... Read more
3-13-21 Shot, soreness in arm and knot nothing else notable except maybe mild headache 3-23 start with itchy rash mid back, arm still sore knot smaller 3-24 Rash continued to spread up back extremely itchy 3-25 Rash continue to spread to stomach area , major head ache, vomiting (one time) temperature 97.1 3-26 Rash continue to spreading to left breast headache, no appetite 3-27 Rash continued spreading to buttock cheeks, apatite improving 3-28 Rash continued to spread arms, Knott in arm getting small feeling itchy all over. 3-29 Rash continued to spread to lower limbs. knot in arm almost gone, visit to doctor . Prescribed steroids for 7 days follow up in one week.
66 2021-03-29 pain in extremity 03/28/2021 all day-upper left arm muscle very sore (no redness) 03/29/2021- 06:00am- 100.4 temp, nau... Read more
03/28/2021 all day-upper left arm muscle very sore (no redness) 03/29/2021- 06:00am- 100.4 temp, nausea/projectile vomiting, fatigue, headache, chills, body aches 03/30/2021 - no symptoms
66 2021-03-30 weakness WEAKNESS, FATIGUE. SHAKY, DIZZY. HYPERTENSIVE 190/80. REQUESTED TO GO TO THE ER. DISCHARGED HOME AFT... Read more
WEAKNESS, FATIGUE. SHAKY, DIZZY. HYPERTENSIVE 190/80. REQUESTED TO GO TO THE ER. DISCHARGED HOME AFTER EVAL IN THE ER
66 2021-03-30 numbness On Saturday 3/20/21, Patient developed a circular rash below injection site on left arm. She had sw... Read more
On Saturday 3/20/21, Patient developed a circular rash below injection site on left arm. She had swelling and pain from left shoulder to elbow and radiating pain up to neck and down to hand with numbness in hand. Patient said the rash lasted about 2-3 days. On 3/27/21, Patient went to ER due to pain and was given naproxen. She went back to ER on 3/29/21 due to continuing to have pain. She is to follow up with PCP this week.
66 2021-04-01 feeling cold, difficulty speaking Approximately 10 minutes into the patient's 15 minute after vaccine monitoring time, she reported re... Read more
Approximately 10 minutes into the patient's 15 minute after vaccine monitoring time, she reported redness of upper extremities bilaterally. Patient taken to emergency medical area of public health vaccine clinic where she then reported numbness/tingling to the lips, Patient started to experience a "funny feeling in legs/feet", hives on chest and lower extremities. Blood pressure was 226/139. IV established LAC 20 gauge with EMS/Fire called. Patient transported to Campus via EMS. Patient contacted on 04/02/2021 via phone to obtain patient's current status: patient stated she was kept in hospital ER for 6 hours, developed further rash to face and back,felt really cold/freezing, and had shortness of breath while at hospital. Patient states she was given pepcid, prednisone, benadryl while at hospital; had lab work-CBC w/ diff, CMP, chest x-ray, 12 lead EKG. Patient discharged home with prescriptions for an Epi-Pen, benadryl, prednisone and pepcid. Patient reports she has a raspy voice, itchiness, some chest tightness, throat feels "a little tight like you are starting to come down with something" and headache that started morning of 04/02/2021.
66 2021-04-03 nerve pain muscle, joint and nerve pain; headaches for two weeks post vaccine
66 2021-04-03 night sweats Extreme Fatigue, slept, woke up drenched in sweat resembling fever breaking. Worst symptoms lasted ... Read more
Extreme Fatigue, slept, woke up drenched in sweat resembling fever breaking. Worst symptoms lasted approximately 6 hours. Slept well all night. No symptoms today.
66 2021-04-04 pain in extremity BOTH EYES WERE IRRITATED; BOTH EYES WERE RED; DIZZINESS; FELL AGAINST SINK; FEELING VERY BAD; HEADAC... Read more
BOTH EYES WERE IRRITATED; BOTH EYES WERE RED; DIZZINESS; FELL AGAINST SINK; FEELING VERY BAD; HEADACHE RADIATING TO SHOULDER AND NECK; TEMPERATURE 101.4 F; MUSCLE ACHES TO BILATERAL BUTTOCKS AND BILATERAL THIGHS; LEFT ARM PAIN ALL THE WAY TO THE BACK OF THE SHOULDER; VERY BAD HEADACHE; NOSE SWELLING; LIP SWELLING; LEFT EYE SWELLING; FEELS NASAL PASSAGE CLOSED; LEFT EYE NOT OPENING COMPLETELY; LEFT EYE TEARING; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 218 pounds, and height was 62 inches. The patient's past medical history included anaphylaxis (closed throat) to sulfa, and concurrent conditions included asthma, sulfa allergy, corn allergy, non-alcoholic, smoker, hypothyroidism, seasonal allergies, and allergy to pcn, and other pre-existing medical conditions included the patient have allergy to caines. the patient did not have any drug abuse/illicit drug use. The patient was previously treated with epinephrine for anaphylaxis (closed throat) to sulfa. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: unknown) dose was not reported, administered on left arm on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced left arm pain all the way to the back of the shoulder. On 24-MAR-2021, the subject experienced very bad headache. On 24-MAR-2021, the subject experienced nose swelling. On 24-MAR-2021, the subject experienced lip swelling. On 24-MAR-2021, the subject experienced left eye swelling. On 24-MAR-2021, the subject experienced left eye not opening completely. On 24-MAR-2021, the subject experienced left eye tearing. On 24-MAR-2021, the subject experienced feels nasal passage closed. On 25-MAR-2021, the subject experienced both eyes were irritated. On 25-MAR-2021, the subject experienced both eyes were red. On 25-MAR-2021, the subject experienced dizziness. On 25-MAR-2021, the subject experienced feeling very bad. On 25-MAR-2021, the subject experienced temperature 101.4 f. On 25-MAR-2021, the subject experienced muscle aches to bilateral buttocks and bilateral thighs. On 25-MAR-2021, the subject experienced fell against sink. On 25-MAR-2021, the subject experienced headache radiating to shoulder and neck. Laboratory data included: Body temperature (NR: not provided) 101.4 F. The action taken with covid-19 vaccine was not applicable. The patient was recovering from dizziness, had not recovered from nose swelling, lip swelling, temperature 101.4 f, left arm pain all the way to the back of the shoulder, very bad headache, left eye swelling, both eyes were irritated, left eye tearing, muscle aches to bilateral buttocks and bilateral thighs, both eyes were red, and left eye not opening completely, and the outcome of feeling very bad, feels nasal passage closed, fell against sink and headache radiating to shoulder and neck was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
66 2021-04-06 muscle spasms headaches, lethargy, cramps in my feet,
66 2021-04-07 facial paralysis, face paralysis Patient developed bilateral facial weakness starting on 4/3/2021, progressed over the course of five... Read more
Patient developed bilateral facial weakness starting on 4/3/2021, progressed over the course of five days until she presented to the emergency department on 4/8/2021. Exam with bilateral CN VII palsy and lower extremity areflexia. MRI brain shows enhancement of bilateral CN VII and VIII. Suspect GBS, treating with IVIG.
66 2021-04-07 pain in extremity Arm Soreness
66 2021-04-09 numbness Numbness & Tingling left corner of my lips/mouth, started 40 minutes after vaccine , lasting 3 hour... Read more
Numbness & Tingling left corner of my lips/mouth, started 40 minutes after vaccine , lasting 3 hours. Bilateral numbness to skin on knees noted in the middle of night while sleeping & resolved upon waking today @ 6:00am.
66 2021-04-09 pain in extremity, feeling cold went to bed at 10, and was cold but that's normal. about 12am was getting colder and back hurt. we... Read more
went to bed at 10, and was cold but that's normal. about 12am was getting colder and back hurt. went to couch with heating pad, was so terribly tired, little nauseous, went to bathroom 8times. got up at 6am with husband and crawled into bed and slept, didnt hear anything happening in the house, just slept. got up to couch again and heating pad, then bed again. freezing and warm and sweating head. at 12 noon finally 'woke' up and got up and sat on couch but didn't feel need to sleep as much. ate a little at 1pm, now am sweating like a fever broke, not cold anymore. headache yet, stiff neck, arm sore
66 2021-04-09 tingling SWELLING IN ARM; SWELLING OF FACE; TINGLING OF BODY; THROAT STARTED TO CONSTRICT; LEGS ARE ITCHY; SH... Read more
SWELLING IN ARM; SWELLING OF FACE; TINGLING OF BODY; THROAT STARTED TO CONSTRICT; LEGS ARE ITCHY; SHAKY FEELING ALL OVER; RASH ON TORSO; CHILLS; KILLER HEADACHE; LITTLE BIT OF NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination, vaccinated at the left arm at 12:00 PM. No concomitant medications were reported. On 01-APR-2021, the subject experienced swelling in arm. On 01-APR-2021, the subject experienced swelling of face. On 01-APR-2021, the subject experienced tingling on face. On 01-APR-2021, the subject experienced tingling of body. On 01-APR-2021, the subject experienced throat started to constrict. On 01-APR-2021, the subject experienced legs are itchy. On 01-APR-2021, the subject experienced shaky feeling all over. On 01-APR-2021, the subject experienced rash on torso. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced killer headache. On 01-APR-2021, the subject experienced little bit of nausea. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swelling of face, tingling on face, tingling of body, throat started to constrict, chills, shaky feeling all over, and little bit of nausea, and had not recovered from swelling in arm, rash on torso, legs are itchy, and killer headache. This report was non-serious.
66 2021-04-10 weakness, pain in extremity My are has hurt since the shot, it hurts to lift my arm up and aches into the shoulder, have been na... Read more
My are has hurt since the shot, it hurts to lift my arm up and aches into the shoulder, have been nauscious and started vomiting on 4/11, have had a bad head ache. Body Ache all over. Feeling very weak.
66 2021-04-10 feeling hot Pt was feeling hot and was on verge of fainting. Had pt lie down in supine position and applied ice ... Read more
Pt was feeling hot and was on verge of fainting. Had pt lie down in supine position and applied ice pack to foreheard and pt felt better
66 2021-04-10 numbness COLD; NUMB TONGUE/NUMBNESS AT THE BACK OF THE TONGUE; TINGLING TONGUE/TINGLING AT THE BACK OF THE TO... Read more
COLD; NUMB TONGUE/NUMBNESS AT THE BACK OF THE TONGUE; TINGLING TONGUE/TINGLING AT THE BACK OF THE TONGUE; NUMB FACE; SWOLLEN JAW; SWOLLEN NOSE; RUNNY NOSE; SORE THROAT; SCRATCHY THROAT; SWOLLEN LYMPH NODES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 in Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced swollen lymph nodes. On MAR-2021, the subject experienced swollen nose. On MAR-2021, the subject experienced runny nose. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced scratchy throat. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced numb tongue/numbness at the back of the tongue. On 15-MAR-2021, the subject experienced tingling tongue/tingling at the back of the tongue. On 15-MAR-2021, the subject experienced numb face. On 15-MAR-2021, the subject experienced swollen jaw. On 25-MAR-2021, the subject experienced cold. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numb tongue/numbness at the back of the tongue, tingling tongue/tingling at the back of the tongue, numb face, and swollen jaw on 15-MAR-2021, had not recovered from cold, and the outcome of swollen lymph nodes, runny nose, fever, sore throat, headache, swollen nose and scratchy throat was not reported. This report was non-serious.
66 2021-04-10 migraine Feels like flu. Dizzy, room spinning, ears hurt, throwing up, tummy ache and Migraine.. Hard to see
66 2021-04-11 burning sensation About 30 minutes after the vaccination (on the way home), I felt very faint and almost passed out. A... Read more
About 30 minutes after the vaccination (on the way home), I felt very faint and almost passed out. At the same time, my injection arm started burning. Also, I started experience a mild headache while on the way home which became VERY bad about an hour after the vaccination (at home). My head, neck and shoulders hurt so badly that I could not move and my vision was blurry; it was a searing type of pain. Then, I developed a fever which, at its highest temperature, was 101.6° along with overall achiness, malaise and severe fatigue,
66 2021-04-11 numbness Arm Numbness and rash all over body, patient took antihistamine rash resolving on 4th day
66 2021-04-12 difficulty speaking Patient presented for Covid vaccination. She had multiple allergies with history of anaphylaxis inc... Read more
Patient presented for Covid vaccination. She had multiple allergies with history of anaphylaxis including to other vaccines. Patient insisted her PCP wanted her to get J & J vaccine. Patient received vaccine at 12:20 AND AT 12:30 C/O of losing voice and feeling like she was reacting. EPI 0.5 given subq at 12:30. BP 138/80; HR 60 and regular. At 12:38 symptoms were getting worse with raspy voice and feeling SOB. Second dose of Epi 0.5 given subq. BP 130/84; HR 64. EMS called. Arrived at 1300 and patient was transported to hospital.
66 2021-04-12 muscle spasms Chills, body aches, muscle cramps, fever up to 102.9
66 2021-04-12 pain in extremity High blood pressure day of vaccine Shortness of Breath continues, but better Pain in upper shoulder ... Read more
High blood pressure day of vaccine Shortness of Breath continues, but better Pain in upper shoulder for a month following
66 2021-04-13 weakness I had abdominal pain for 2 to 3 days. I also was light headed, weak and had some dizziness for 2 t... Read more
I had abdominal pain for 2 to 3 days. I also was light headed, weak and had some dizziness for 2 to 3 days. I also had a headache the evening of 3-11-21 and the morning of 3-12-21
66 2021-04-13 burning sensation, pain in extremity Felt leg pain, heavy legs, burning sensation. The symptoms were more acute for the first week, sti... Read more
Felt leg pain, heavy legs, burning sensation. The symptoms were more acute for the first week, still having some symptoms but a little lighter.
66 2021-04-13 burning sensation Body aches, feeling burning almost like when having shingles.
66 2021-04-13 facial pain, tenderness The patient is a 66 y.o. female with past history of diabetes, GERD and HTN who presents to the Emer... Read more
The patient is a 66 y.o. female with past history of diabetes, GERD and HTN who presents to the Emergency Department with visual changes of the right eye and associated pain to the face and neck. Per interpretor, patient woke up feeling at baseline yesterday morning, when she had her COVID-19 vaccine. Yesterday around dinner time, she began having issues with vision in her right eye, causing her visual field in that eye to appear dark to her entire right eye. She told her husband that she thought she might have a hair or eyelash in her right eye and that she had an irritating pain radiating from her right eye to the right side of her face. Even after washing her eye with cold water, the sensation did not subside. At approximately 3-4 AM this morning, she also began to experience pain to the back of her head and neck bilaterally. This morning, the visual impairment improved from the entire visual field to now only just the inferior aspect of the right eye. However, she denies weakness to any of her extremities. Patient also denies chest pain, numbness, abdominal pain or nausea. She was seen at ophthalmology, at which Dr. diagnosed her with a right retinal branch arterial occlusion and decided to send her to SHE to be evaluated for the possibility of a CVA. She denies being on blood thinners or taking Aspirin. She denies any previous diagnosis of a CVA or TIA.
66 2021-04-13 numbness Had shot in left arm no problem, a few hours later started getting a headache chills achs and pains ... Read more
Had shot in left arm no problem, a few hours later started getting a headache chills achs and pains nausea stomache pain hands and feet numb. still not feeling good.
66 2021-04-13 pain in extremity, muscle spasms, tenderness Reports of having symptoms of severe bilateral leg pain at night. Started Sunday 4/11/21 at 11:00 pm... Read more
Reports of having symptoms of severe bilateral leg pain at night. Started Sunday 4/11/21 at 11:00 pm and reports pain was so severe it kept her awake for 4-5 hours on night of 4/11-4/12 and had the same leg cramps 4/12 night and 4/13 night, noting the last two episodes did not last as long. Currently report of having swelling to left knee, tenderness to bilateral knees and bilateral calves.
66 2021-04-13 pain in extremity Got the vaccine on Apr 6 Fever and leg pain started on Apr 7 Sever headache, nausea occurred on Apr ... Read more
Got the vaccine on Apr 6 Fever and leg pain started on Apr 7 Sever headache, nausea occurred on Apr 11, called 911 immediately and sent to emergency room of hospital The diagnosis is large volume of subarachnoid hemorrhage in the brain. Surgery conducted on April 11 and the patient is still in ICU now
66 2021-04-13 tremor PAIN BELOW THE INJECTION SITE; LOSS OF APPETITE; SHAKY HANDS; FLU-LIKE SYMPTOMS; SLEPT ALL DAY; TERR... Read more
PAIN BELOW THE INJECTION SITE; LOSS OF APPETITE; SHAKY HANDS; FLU-LIKE SYMPTOMS; SLEPT ALL DAY; TERRIBLE CHILLS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included osteoporosis, high bad cholesterol, and varicose veins. The patient experienced drug allergy when treated with nitrofurantoin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced shaky hands. On APR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced slept all day. On APR-2021, the subject experienced terrible chills. On 06-APR-2021, the subject experienced pain below the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and pain below the injection site on APR-2021, was recovering from loss of appetite, shaky hands, and terrible chills, and the outcome of slept all day was not reported. This report was non-serious.
66 2021-04-14 pain in extremity, migraine Shortness of breath and tightness of chest for a week and several palpitations. Autoimmune response... Read more
Shortness of breath and tightness of chest for a week and several palpitations. Autoimmune response similar to Hashimoto's attack with severe inflammation in heart and body, migraine headache, fever, chills, body aches intermittently over three weeks. Hands and feet hurt three weeks. Could not make a fist.
66 2021-04-14 pain in extremity Leg Pains Unable to sleep due to pains Hot spots on legs Difficulty walking Fever
66 2021-04-15 feeling cold SMELLY URINE; CLOUDY URINE; ABDOMINAL CRAMPS; DIZZINESS; HEART RACING; FEELING COLD; BRAIN FOG; NECK... Read more
SMELLY URINE; CLOUDY URINE; ABDOMINAL CRAMPS; DIZZINESS; HEART RACING; FEELING COLD; BRAIN FOG; NECK SORE; SOUND IN HEAD/HUMMING NOISE IN HEAD; DID NOT FEEL HUNGRY; FORGETFULLNESS; SHAKING WITH COLD/TEETH CHATTER/CHILLS; SEVERE HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included cholesterol, and concurrent conditions included hypertension, non-smoker, non- alcoholic, and sensitive to medications, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. the patient had no known drug allergies. The patient was previously treated with hydrochlorothiazide/lisinopril for hypertension, vitamins nos for drug used for unknown indication, and atorvastatin for cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Blood test (NR: not provided) not reported. On 12-MAR-2021, the subject experienced heart racing. On 12-MAR-2021, the subject experienced feeling cold. On 12-MAR-2021, the subject experienced brain fog. On 12-MAR-2021, the subject experienced neck sore. On 12-MAR-2021, the subject experienced sound in head/humming noise in head. On 12-MAR-2021, the subject experienced did not feel hungry. On 12-MAR-2021, the subject experienced forgetfullness. On 12-MAR-2021, the subject experienced shaking with cold/teeth chatter/chills. On 12-MAR-2021, the subject experienced severe headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced smelly urine. On 02-APR-2021, the subject experienced cloudy urine. On 02-APR-2021, the subject experienced abdominal cramps. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) NEGATIVE, Computerised tomogram head (NR: not provided) NEGATIVE, Fibrin D dimer (NR: not provided) ELEVATED, and Head MRI (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling cold, and fever on 12-MAR-2021, and smelly urine, cloudy urine, and abdominal cramps on APR-2021, was recovering from neck sore, and had not recovered from heart racing, shaking with cold/teeth chatter/chills, severe headache, nausea, did not feel hungry, brain fog, sound in head/humming noise in head, dizziness, and forgetfullness. This report was non-serious.; Sender's Comments: : V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious
66 2021-04-15 muscle spasms, muscle twitching FATIGUE/SLIGHTLY TIRED; FEVER; CHILLS; HEADACHE; LEG CRAMPS; TWITCHY MUSCLES; BACK ACHES; ACHES; THI... Read more
FATIGUE/SLIGHTLY TIRED; FEVER; CHILLS; HEADACHE; LEG CRAMPS; TWITCHY MUSCLES; BACK ACHES; ACHES; THIRSTY; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and prolapsed mitral valve. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 10-APR-2021 14:00 for prophylactic vaccination. Concomitant medications included levothyroxine for drug used for unknown indication, atenolol for high blood pressure, hydrochlorothiazide for high blood pressure, and acetylsalicylic acid. On APR-2021, Laboratory data included: Blood pressure (NR: not provided), and Fever (NR: not provided) 92.7 F. On 10-APR-2021, the subject experienced leg cramps. On 10-APR-2021, the subject experienced twitchy muscles. On 10-APR-2021, the subject experienced back aches. On 10-APR-2021, the subject experienced aches. On 10-APR-2021, the subject experienced thirsty. On 10-APR-2021, the subject experienced headache. Laboratory data included: Fever (NR: not provided) 103 F. On 10-APR-2021 17:00, the subject experienced chills. On 10-APR-2021 20:00, the subject experienced fever. On 10-APR-2021 23:00, the subject experienced fatigue/slightly tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg cramps, twitchy muscles, back aches, aches, thirsty, chills, fever, and headache on 11-APR-2021, and was recovering from fatigue/slightly tired. This report was non-serious.
66 2021-04-15 pain in extremity Dull headache for several days. Excruciating abdominal cramping off and on for almost a week. Arm so... Read more
Dull headache for several days. Excruciating abdominal cramping off and on for almost a week. Arm soreness appeared about a week later severe enough to keep me from sleeping on that side of my body. Lasted about a week. At the same time, large bruises appeared on the "shot arm" from the shoulder down almost to my elbow. Soreness in my right calf developed after four weeks and still comes at times.
66 2021-04-15 pain in extremity Sudden onset left calf pain 4/2, increasing swelling and pain, presented for evaluation 4/9, SVT and... Read more
Sudden onset left calf pain 4/2, increasing swelling and pain, presented for evaluation 4/9, SVT and DVT noted on ultrasound same day, started on Eliquis to manage clot.
66 2021-04-15 pain in extremity MUSCLE REFLEX WHICH CAUSED ARM TO MOVE; VACCINE PROVIDED A LITTLE HIGH ON ARM; PAIN IN ARM; This spo... Read more
MUSCLE REFLEX WHICH CAUSED ARM TO MOVE; VACCINE PROVIDED A LITTLE HIGH ON ARM; PAIN IN ARM; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and sulfonamide allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced muscle reflex which caused arm to move. On 06-APR-2021, the subject experienced vaccine provided a little high on arm. On 06-APR-2021, the subject experienced pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm on 06-APR-2021, and the outcome of muscle reflex which caused arm to move and vaccine provided a little high on arm was not reported. This report was non-serious.
66 2021-04-15 pain in extremity LEFT ARM PAIN/SORE ARM; This spontaneous report received from a patient concerned a 66 year old fema... Read more
LEFT ARM PAIN/SORE ARM; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, cholitis, crohn's disease, irritable bowel syndrome, fibromyalgia, constipation, diarrhea, reflux, and high blood pressure. The patient experienced drug allergy when treated with propofol for anesthesia, drug allergy when treated with aspartame, ceftriaxone sodium/tazobactam sodium, clarithromycin, and clarithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced left arm pain/sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left arm pain/sore arm on 12-MAR-2021. This report was non-serious.
66 2021-04-16 pain in extremity Leg and hip pain. Small random sores on hand, stomach, leg and back of neck
66 2021-04-18 flushing, pain in extremity, tremor Transcribed from hard copy filled out by Pt who was unable to download to submit---- 4/08 3am: drenc... Read more
Transcribed from hard copy filled out by Pt who was unable to download to submit---- 4/08 3am: drenched in sweat: VIOLANT headache: SEVERE all-over body aches lasting 24hours. 9am: drenching sweats, nausea, hypersensitivity, hperacusis, overwhelming fatigue, mild nausea. 4/10 : seas, flushing , shaky, lightheaded. 4/11: body tremors, sweats, chills, nausea, diarrhea,. 7pm: tinnitus: severe body aches-diazepam. 4/12: Tinnitus resolved: flushing, profuse diarrhea,: Imodium. 4/313: diarrhea. Polyuria about every 2 hours the entire 6 days, even when taking little to no fluids. No fevers-i never run a fever. When body aches subsided, severe post-op spine and associated leg pain vanished, has not returned.
66 2021-04-20 migraine I had been sick since this past Friday; high fever, all over body pain, constant cough and frequent ... Read more
I had been sick since this past Friday; high fever, all over body pain, constant cough and frequent sneezing, migraines , eye pain and extreme fatigue. I tested positive for Covid April 21, 2021.
66 2021-04-20 pain in extremity, tingling, muscle spasms BODY ACHES; INSOMNIA; ENLARGED LYMPH NODE IN LEFT UNDERARM; TINGLING IN ARM; CHILLS; HEADACHE; FEVER... Read more
BODY ACHES; INSOMNIA; ENLARGED LYMPH NODE IN LEFT UNDERARM; TINGLING IN ARM; CHILLS; HEADACHE; FEVER; FATIGUE; MUSCLE SPASM; PAIN IN ARM; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pre existing arthritis. The patient experienced drug allergy when treated with hydrochlorothiazide/methyldopa, cefalexin, and diazepam. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle spasm. On APR-2021, the subject experienced pain in arm. Laboratory data included: CAT scan (NR: not provided) Pre-existing arthritis, and X-ray (NR: not provided) Pre-existing arthritis. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced insomnia. On 01-APR-2021, the subject experienced enlarged lymph node in left underarm. On 01-APR-2021, the subject experienced tingling in arm. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced fatigue. On 14-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) No problem in lymph node. Treatment medications (dates unspecified) included: paracetamol, and oxycodone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from insomnia on 13-APR-2021, chills, and headache, and fever on 06-APR-2021, was recovering from fatigue, had not recovered from body aches, and enlarged lymph node in left underarm, and the outcome of pain in arm, tingling in arm and muscle spasm was not reported. This report was non-serious.
66 2021-04-21 burning sensation I can't say for sure but 9 days after receiving the vaccine, my condition called Erythromelalgia fla... Read more
I can't say for sure but 9 days after receiving the vaccine, my condition called Erythromelalgia flared up terribly, which involved uncomfortable to intense burning of the outer ears 24/7 with no relief. It calmed down for a couple of days and then came back with other symptoms, including the burning ears, and parts of my neck and face. In addition to that, my eyes were bloodshot and had drainage coming from them and in the morning, it appeared that they had like a lining of film over them. Skin is peeling due to all the burning in the areas described. Several different treatments were tried but none has slowed down the flare-up. After another trip back to the NP, she said that it was inflamation and gave me a steroid shot along with prednisone tablets. I also went to an optometrist who found some things wrong with my eyes and prescribed some steroid eye drops. Before the vaccine, we pretty much had the Erythromelalgia under control with meds but this time, it's been hard to get things under control and more tolerable.
66 2021-04-21 pain in extremity LEG PAIN AND CALLER COULD NOT BEND DOWN ALL THE WAY AND HAVING A HARD TIME GOING UP AND DOWN THE STA... Read more
LEG PAIN AND CALLER COULD NOT BEND DOWN ALL THE WAY AND HAVING A HARD TIME GOING UP AND DOWN THE STAIRS; FATIGUE; FLU LIKE SYMPTOMS ON 16TH MARCH AND IT WAS WORSENED ON 9TH APRIL TO 11TH APRIL; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 97 pounds, and height was 66 inches. The patient's concurrent conditions included bell's palsy on right side of face;, nonsmoker, and abstains from alcohol, and other pre-existing medical conditions included no unknown allergies no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. Concomitant medications included clonazepam for muscle relaxant for bell's palsy. On 16-MAR-2021, the subject experienced flu like symptoms on 16th march and it was worsened on 9th april to 11th april. On 04-APR-2021, the subject experienced leg pain and caller could not bend down all the way and having a hard time going up and down the stairs. On 04-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 16th march and it was worsened on 9th april to 11th april on 12-APR-2021, and had not recovered from leg pain and caller could not bend down all the way and having a hard time going up and down the stairs, and fatigue. This report was non-serious.
66 2021-04-22 tingling Tingling throw out body. Diarrhea. Occasional skin redness
66 2021-04-23 weakness DIZZINESS; APPETITE WAS POOR THAT THERE WAS DIFFICULTY IN FINISHING A MEAL; FEVER; COUGHING; WEAKNES... Read more
DIZZINESS; APPETITE WAS POOR THAT THERE WAS DIFFICULTY IN FINISHING A MEAL; FEVER; COUGHING; WEAKNESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported, administered administered to the right arm, on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced weakness. On 29-MAR-2021, the subject experienced coughing. On 29-MAR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced appetite was poor that there was difficulty in finishing a meal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 08-APR-2021, and had not recovered from weakness, coughing, appetite was poor that there was difficulty in finishing a meal, and dizziness. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
66 2021-04-23 weakness LETHARGY; OVERALL ACHES/SORENESS; NO ENERGY; NAUSEA; TIREDNESS; This spontaneous report received fro... Read more
LETHARGY; OVERALL ACHES/SORENESS; NO ENERGY; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included anxiety/depression, and concurrent conditions included non alcohol user, non smoker, and dry cough, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage history. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805051, and batch number: 1805051 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced lethargy. On 27-MAR-2021, the subject experienced overall aches/soreness. On 27-MAR-2021, the subject experienced no energy. On 27-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargy, and nausea, and the outcome of overall aches/soreness, tiredness and no energy was not reported. This report was non-serious.
66 2021-04-23 numbness, tingling NUMBNESS ON THE FACE; TINGLES ON THE FACE; This spontaneous report received from a patient concerned... Read more
NUMBNESS ON THE FACE; TINGLES ON THE FACE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hbp, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 in the right arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced numbness on the face. On 12-MAR-2021, the subject experienced tingles on the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on the face, and tingles on the face. This report was non-serious.
66 2021-04-25 pain in extremity Diarrhea (persisting) Fatigue (persisting) Vomiting (resolved) Sore arm (resolved) Decreased stamina... Read more
Diarrhea (persisting) Fatigue (persisting) Vomiting (resolved) Sore arm (resolved) Decreased stamina (persisting)
66 2021-04-29 weakness Patient presented to hospital with four days chest pain, dyspnea on exertion and weakness. Work up r... Read more
Patient presented to hospital with four days chest pain, dyspnea on exertion and weakness. Work up revealed an acute submassive pulmonary embolism without evidence of deep vein thrombosis in bilateral lower extremities.
66 2021-04-29 pain in extremity APPROXIMATELY 3 DAYS AFTER RECEIVING THE SHOT I BEGAN TO EXPERIENCE PAIN IN THE RIGHT SIDE OF MY NEC... Read more
APPROXIMATELY 3 DAYS AFTER RECEIVING THE SHOT I BEGAN TO EXPERIENCE PAIN IN THE RIGHT SIDE OF MY NECK WHICH WORSENED AND EXTENDED DOWN INTO THE RIGHT SHOULDER BLADE AND THEN TO MY RIGHT ARM AND CONTINUED DOWN INTO MY RIGHT LEG. THE PAIN HAS CONTINUED FOR OVER ONE MOTH NOW.
66 2021-05-02 flushing, burning sensation Patient received J&J Covid Vaccine at 1:46 pm. At approx. 2:05 pm she stated she had an increased H... Read more
Patient received J&J Covid Vaccine at 1:46 pm. At approx. 2:05 pm she stated she had an increased HR (wears wrist monitor) and was light headed. Spoke to patient about if she had previously felt this way after a vaccine and she stated she felt this after her "first covid vaccine". After questioning, she stated that she had received a Pfized Covid Vaccine in February which was not noted in her consent form. She also did not note that she had been hospitalized post-vaccination for a burning sensation and flushing that would not cease. She received the J&J vaccine at the advice of her primary care physician but had not advised pharmacy staff. After discussing it with the patient, it was determine that EMS would be called. EMS came to evaluate patient.
66 2021-05-02 pain in extremity, numbness Ultrasound done on 4-30-2021 for pain in calf of left leg and numbness of the toes for 7 days. Resul... Read more
Ultrasound done on 4-30-2021 for pain in calf of left leg and numbness of the toes for 7 days. Result came back positive for blood clot.
66 2021-05-12 tingling, weakness, pain in extremity NERVE TINGLING IN LEFT THIGH; LEFT LEG PAIN CENTRED IN KNEE; GENERAL WEAKNESS; CHEST TIGHTNESS; This... Read more
NERVE TINGLING IN LEFT THIGH; LEFT LEG PAIN CENTRED IN KNEE; GENERAL WEAKNESS; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included low thyroid, penicillin allergy, sulfa drugs allergy, and allergy to mango, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with naproxen. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 42A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chest tightness. On 11-APR-2021, the subject experienced nerve tingling in left thigh. On 11-APR-2021, the subject experienced left leg pain centred in knee. On 11-APR-2021, the subject experienced general weakness. On 10-MAY-2021, treatment medications included: meloxicam. The action taken with covid-19 vaccine was not applicable. The patient recovered from chest tightness, and had not recovered from left leg pain centred in knee, nerve tingling in left thigh, and general weakness. This report was non-serious.
66 2021-05-18 pain in extremity Feel little bit pain in right arm, no fever
66 2021-05-24 migraine I had a horrible migraine. After I described it to my Ophthalmologist, Dr. , he said he didn't belie... Read more
I had a horrible migraine. After I described it to my Ophthalmologist, Dr. , he said he didn't believe it to be a typical migraine. I had vision disturbance in my right eye for about 2 weeks. After one week, I called my doctor. I'm not sure if it has cleared up or my brain has become used to it. I had a MRI and I followed up with a Neurosurgeon and he said I have a small brain tumor (meningioma), but it was not a part of the problem. I think that if the Janssen Vaccine hadn't been paused around the time I had my migraine, I wouldn't have been so alarmed and worried.
66 2021-05-24 pain in extremity About a week after receiving the vaccination, her arm began to ache. She states that it has not impr... Read more
About a week after receiving the vaccination, her arm began to ache. She states that it has not improved and seems to be getting worse.
66 2021-05-25 electric shock sensation Patient received Johnson&Johnson CV-19 1805018 5/21 on March 9, 2021. Patient began experiencing ch... Read more
Patient received Johnson&Johnson CV-19 1805018 5/21 on March 9, 2021. Patient began experiencing chest pains and abnormal sensations in chest area beginning April 26, 2021. Patient began experiencing electrical-like abnormalities in both hands and feet that cause severe dysfunction beginning May 7, 2021. Patient developed blood clot behind the retina of right eye as examined by ophthalmologist during clinical visit on May 25, 2021 at 8:15am appointment.
66 2021-05-25 feeling of body temperature change, tremor Developed shakes, chills, alternating hot and cold flashes, fatigue, muscular aches starting at 11:4... Read more
Developed shakes, chills, alternating hot and cold flashes, fatigue, muscular aches starting at 11:45 pm. Has let up some - shakes have stopped. and am generally feeling better (4:00 pm).
66 2021-05-27 migraine, tremor Uncontrollable Shaking, PVC?s, fever, nauseous, migraine, chills, extreme, fatigue, unable to sleep
66 2021-05-29 feeling of body temperature change After the vaccine I had a headache. With the headache I became nausea and had serve diarrhea. I was ... Read more
After the vaccine I had a headache. With the headache I became nausea and had serve diarrhea. I was always hot or cold and ran a fever. and also experienced chills. I also did not have a appetite.
66 2021-05-29 tingling I had facial tingling which included the mouth and jaw, and my vision was blurred. I was also a litt... Read more
I had facial tingling which included the mouth and jaw, and my vision was blurred. I was also a little lightheaded which subsided but did not go away completely. The next day I was better, but I had soreness around the injection site. I also had diarrhea.
66 2021-06-08 pain in extremity Waited 30 minutes after shot at clinic, just sore in upper arm. About 45 min after vaccine in car, ... Read more
Waited 30 minutes after shot at clinic, just sore in upper arm. About 45 min after vaccine in car, shooting pain in upper arm that went down my forearm, and up neck, stopped and then started up again... - lasted for about 10 min. thought I was having a heart attack, but it all subsided. My husband felt it was anxiety - Happened again when we got home on and off, we thought sore muscle - subsided. Wakes me up at night sometimes, happens occasionally during day, happens when golfing - asked a PA friend in heart department at hospital and she said it may take time to heal from vaccine bruising. Past 3 days got another cold virus and yesterday my vaccine site and forearm was killing me all day off and on, a couple of times up same side neck. Got me concerned enough today to call Tri-county who scheduled vaccine to see if anyone else had similar symptoms - told me to fill this form out. I was concerned it was a blood clot. Better today- dull pain off and on.
66 2021-06-10 weakness Approximately 12 hours after receiving the injection, I became weak and tired within minutes. My hea... Read more
Approximately 12 hours after receiving the injection, I became weak and tired within minutes. My heart began to have palpitations and my heart rate which is usually in the 50s or 60s shot up to 84. My blood pressure was good at 109 over 74. The palpitations lasted until approximately 5:00 a.m. I did not seek medical attention.
66 2021-06-15 pain in extremity, muscle spasms Significant muscle and joint pain, particularly in legs, mostly in right but varies. Feelings of cr... Read more
Significant muscle and joint pain, particularly in legs, mostly in right but varies. Feelings of cramping right calf. Went to ER, ultrasound negative, bloodwork unremarkable, MD visit later, was told to reduce inflammation via diet and moderation of activity. Symptoms have continued until present and have affected ADLs
66 2021-06-27 tingling, pain in extremity First 5 days-fever, pain joints muscles lightheaded Since to date- racing heart and pulse. Severe d... Read more
First 5 days-fever, pain joints muscles lightheaded Since to date- racing heart and pulse. Severe dizzy spells. Intense pain and tingling I n legs.
66 2021-07-11 pain in extremity The signs started with light headiness, fatigue, unbalanced after walking a block. Felt like I was g... Read more
The signs started with light headiness, fatigue, unbalanced after walking a block. Felt like I was going to pass out. Next it was headaches and they got worst and felt like some one was pounding something in my head. Ear pressure with headaches and the next to unbearable is the feeling like my body is moving and I am not moving. A wave sensation that comes and goes almost like I am not in control of what's going on in my brain. My blood pressure started to dropped for a week down to 105/68 daily. I went to emergency room because of pain in left arm. At times I feel things in my brain like moving around. I don't know how to explain it but it's scary. I have been to a previous Dr for help but lots of test no results. I am not seeing Dr, had a balanced test done it came back very good. I will see a Neurologist on 7/13 to see if she can help. Please help me!!
66 2021-07-13 numbness, pain in extremity Instant headache and pain shooting down arm and side while being injected, sick feeling and light he... Read more
Instant headache and pain shooting down arm and side while being injected, sick feeling and light headed right as I was leaving the facility. Within 4 hours I was struggling to do anything. I was tired and felt and nauseated, light headed and felt like i was hit by a truck. The bottoms of my feet hurt and I had stabbing pains so bad in my knee joints I could barely walk without assistance. I felt very ill for about a week after the shot but the headaches continued constantly for over a month but aren't daily anymore even though I still have them, and the fatigue was getting worse and still is a problem to this day. Once I was feeling a bit better my right knee started to give out and my left knee was cracking. Since I got that vaccine on 3/6/21 I have had back to back problems. Below is a quick list of these things that have occurred by dates: 3/30/21 - Constant headaches since the vaccine and ear pain and throat issues. 4/16/21 - Right knee giving out on me that started shortly after vaccine and gotten worse. X-ray and physical therapy ordered. 4/22/21 - Shortness of breath, back pain, constant fatigue. Blood work that showed elevated D-dimer then chest x-ray and ct-scan ordered. 4/26/21 - Ultrasound for nodule found on ct-scan. 5/4/21 - Biopsy done of mediastinal mass. 5/11/21 - Physical done for surgery. 5/24/21 - Surgery to remove mediastinal mass, right side of thyroid, two parathyroids and lymph nodes. 6/1/21 - Follow-up for surgery. When I asked why this happened, the doctor said we may never know but the biopsy of the right thyroid nodule result showed thyroiditis, Autoimmune/Hashimoto's, and that my immune system attacked my thyroid. The doctor said she tested me for that in 9/20 and it was negative. 6/2/21 - Left knee pain. About 4 days after my surgery on 5/24 i turned towards the door and heard a loud pop in my left knee. It had been crackling since the vaccine but wasn't giving out like the right one. I couldn't walk on it at all and was using crutches. 6/9/21 - Mri on left knee showed medial and lateral meniscus tears. Referred to Ortho Dr. 6/28/21 - Test thyroid levels post op. TSH levels high. Referral to Endocrinologist. 6/30/21 - Left knee treatment, cortisone shot in knee for now to help with pain and inflammation so I can function and physical therapy. Since then my 4th toe on my right foot has been numb for almost two weeks. I am scheduled for numerous future physical therapy appointments and doctors appointments. Then to make matters worse I just heard 2 days ago that J&J is having more issues and mentioned autoimmune and wondered could that be what caused all of this? I regret getting that stupid J&J vaccine. I expected it to he the Pfizer because that is what was there 2 days before I got my shot. I told the person I didn't want it and she got someone in charge to talk me into it. I should have walked out of there and I am mad at myself for caving to this woman. If J&J says we need a booster I will refuse to take it. I don't know if the vaccine was what triggered all of this but I find it quite odd that all of this started almost immediately after I got that vaccine. Not only to me but also to my sister who got it at the same time. She fell within 30 minutes of getting that vaccine and 3 more times that day, and has had and is still having numerous problems that mimic mine, such as issues with her feet and legs. She struggles to walk and is having issues with her thyroid among other things that she wasn't having a problem with prior to the vaccine. This is just the short version of all I have been through. Any questions feel free to contact me.
66 2021-07-14 coordination abnormal, numbness Numbness of extremities, flu, loss of appetite, headache, sluggishness, joint pain, loss of coordina... Read more
Numbness of extremities, flu, loss of appetite, headache, sluggishness, joint pain, loss of coordination, and confusion.
66 2021-07-14 pain in extremity My arm hurt a little bit, but I didn't have a fever. I didn't really have any reactions to the vacci... Read more
My arm hurt a little bit, but I didn't have a fever. I didn't really have any reactions to the vaccine.
66 2021-07-14 tingling NUMBNESS AND TINGLING RIGHT FOOT MOSTLEY TOES
66 2021-07-16 muscle spasms, numbness, flushing Painful injection site right away And within 20 min very painful left side-shoulder blade, shoulder,... Read more
Painful injection site right away And within 20 min very painful left side-shoulder blade, shoulder, then pain went into neck, then jaw, then ear- felt blocked up and numb, then to eye- vision off, light headed. Pharmacist observed for 30 minutes and suggested I go to urgent care. I thought I was ok but on way home, jaw and cheek area went numb and sharp pain at left base of skull to top of head with chest and underarm muscles sharp pains. Went to urgent care. BP, temp & oxygen ok. While observing me for 45 min, also had left leg cramps, and profuse sweating Gave me 2 prednisone tabs 20 mg. Watched for another 45 minutes. Went home. 7 hours after injection still had these symptoms. Next morning 7/16/21, cheeks flushed, moderate jaw pain, cheek numbness and ear/ hearing not right. As day went on, numbness became intermittent but jaw pain remained.
67 2021-03-06 tremor All symptoms started about 7 hours after injection: Severe chills and shaking (lasted approximately ... Read more
All symptoms started about 7 hours after injection: Severe chills and shaking (lasted approximately 3 hrs) Bad headache (lasted 24 hrs) Exhaustion (lasted 24 hrs) All adverse symptoms gone after 36 Hours from injection.
67 2021-03-07 weakness Overnight on the 6th - muscle aches, chills, fever, headache, weakness. Starting on Sunday morning t... Read more
Overnight on the 6th - muscle aches, chills, fever, headache, weakness. Starting on Sunday morning the 7th - bad nausea all day with vomiting for 12 hours. Barely able to have an ice chip.
67 2021-03-08 weakness Chills - Fever (100 degrees) - Weak/Tired Symptoms lasted 8-10 hours
67 2021-03-09 tingling On 3-10-2021, Covid Vaccine administered IM L deltoid at 12:15 PM. At 12:25 PM Pharmacist was notif... Read more
On 3-10-2021, Covid Vaccine administered IM L deltoid at 12:15 PM. At 12:25 PM Pharmacist was notified patient symptoms of head and face tingling and throat swelling. BP 165/90 pulse 68 at 12:28PM. Patient described s/sx rapidly developing and described severity as 10/10 with difficulty breathing. Epinephrine (Epipen) administered in R thigh at 12:30PM. By 12:34 patient described symptoms as already decreasing to a 7/10 severity. EMS arrived, assessed patient. Continued improvement with no residual effects. EMS dismissed patient to care of her husband without further follow up needed.
67 2021-03-09 tingling All over skin itchiness. Feels like pins and needles under skin.
67 2021-03-10 tingling, pain in extremity At the time of the injection neck and arm were painful-fingers tingled. At about 60 minutes became d... Read more
At the time of the injection neck and arm were painful-fingers tingled. At about 60 minutes became dizzy, headache, About 2 hours after injection body aches, nausea, feeling very tired, teeth began to ache, all over joint pain About 9 hours after injection - low grade fever (~100* F.) and chills
67 2021-03-11 weakness, unresponsive to stimuli Around 10 minutes after vaccine patient reported feeling dizzy, tired and weak. Patient was still r... Read more
Around 10 minutes after vaccine patient reported feeling dizzy, tired and weak. Patient was still responsive, stated she had eaten breakfast. She then was given water. She then became unresponsive, eyes closed, snoring with head slumped down while sitting. After we realized patient could not be awoken, property manager called 911. While ambulance was on thier way, patient "woke up" but was drowsy and could barely communicate. No epinephrine or diphenhydramine was administered. BP was 130/100. After EMS arrived, patient's partner came in from the car and reported this has happened multiple times at doctor appointments/procedures. Patient was unconscious for around 5minutes. Patient reported she went to the ED but was discharged after a short visit.
67 2021-03-12 weakness injection site becoming sore and tender. little headache, really tired. low energy, nausea. This is ... Read more
injection site becoming sore and tender. little headache, really tired. low energy, nausea. This is all very unusual for me.
67 2021-03-12 pain in extremity, tremor Slight chill started about 7:15 p.m. and within minutes my entire body was shaking uncontrollably. ... Read more
Slight chill started about 7:15 p.m. and within minutes my entire body was shaking uncontrollably. After about 1 and 1/2 hours extreme shaking stopped. Felt very wiped out the following day with slight headache and legs hurting.
67 2021-03-13 flushing Patient complained of feeling nausea and warm "flushed" apprx 15 mins post vaccine. VS HR 74, RR 17... Read more
Patient complained of feeling nausea and warm "flushed" apprx 15 mins post vaccine. VS HR 74, RR 17, O2 95, 100/60, wheeled patient outside for fresh air. Patient improved. Left walking to car with family members.
67 2021-03-14 tremor Shaking chills, headache, subjective fever, stuffiness starting 6 hrs after Johnson and Johnson vacc... Read more
Shaking chills, headache, subjective fever, stuffiness starting 6 hrs after Johnson and Johnson vaccine Noted bumps day after vaccine around a superficial vein along L lateral forehead associated with soreness. She had some hyperventilation which also subsided Had HA for 2 days. No clear vision changes, wears contact Had R ear redness briefly but also resolved
67 2021-03-16 pain in extremity Headache, chills, no appetite and tired and sore arm
67 2021-03-18 burning sensation, feeling hot 24 hours after vaccine, hard lump, swollen and pink, moderate chills. The next day, bigger lump, sw... Read more
24 hours after vaccine, hard lump, swollen and pink, moderate chills. The next day, bigger lump, swollen, all just below injection and red, moderate chills, a bit itchy, nausea., and painful. Same on 3rd day but much bigger redness spreading down arm, 2 1/2 by 2 1/2' hard mass and red, itchy, painful, chills and nausea. Next morning called Dr. I am taking amoxicillin-clav 875-125ng tab. Three days later mass is turning from red to pink and retreating. Still hurts and now bruses show around the injection site, which I thought was strange. The vaccine actually hurt when given (I get injections every three months, so I know what they will feel like, but this hurt and went very deeply and then burned). I felt warm afterwards for about 10 minutes.
67 2021-03-18 pain in extremity, cold sweat 15-20 minutes after the injection, I started feeling a tightness in back of my throat; I broke out i... Read more
15-20 minutes after the injection, I started feeling a tightness in back of my throat; I broke out in cold sweat. I started getting dizzy and very whoozy. I felt my vision starting to close in. I thought I was going to pass out. I got the attention of the person across me to get an attendant and they brought me a chair with wheels. Two people got me up (and I'm not a big person) - they were worried I was going down and I was taken to exam room. They said I was white as a sheet. She checked my eyes and throat a few times and checked my blood pressure. It was lower than normal but she didn't seem really concerned about it - 104 over 60 something which is low for me. She gave me water to sip. She gave me very cold compresses to put on my forehead. They watched me pretty good. She had the epi-pen ready. She watched me and I sat in there and nurse came in a quite a few times to check me for about an hour. About an hour later the tightness went away and I started feeling myself again. We went home. I went to sleep. I woke up at night to go to bathroom and I was still a little woozy but I didn't fall. Next day, I just didn't feel well. My left arm was starting to hurt - was no swelling; it was a little red at injection site. It hurt just a little. I was woozy. My eyes couldn't focus as well. I felt out of it. I drank a lot of water and took a nap. Yesterday, I felt pretty decent but still woozy somewhat. I tried to run errands with my husband - just wasn't quite right. Today, much better but I'm not quite myself yet. Just a little wooziness - weird feeling. Yesterday, I did feel a soreness in the back of my right calf muscle. It wasn't warm to the touch or swollen. I don't have it anymore, it went away. It could have been a muscle thing from the first day of the vaccine when I got home and I got up and almost fell down. I do still have some achiness in joints. Especially in my knees - which isn't normal because they are replaced.
67 2021-03-20 pain in extremity Vaccine was painful but then pain partially subsided, then came home and had chills, temp 96F. Went ... Read more
Vaccine was painful but then pain partially subsided, then came home and had chills, temp 96F. Went to bed and had muscle aches, pains and headache. Next morning felt flu like symptoms, malaise especially. Tried to work and could only work 3 hours. Arm remained sore. 14 days later still experiencing soreness in injection site (does not appear swollen), tender to the touch. If arm is lifted up then feels like it is "pulling on something."
67 2021-03-20 pain in extremity March 18 , 2921:Fever 100.9,9:40 p.m. Chills 11:30 p.m., Fever 101.9, 12 a.m. Took 2 Tylenol March... Read more
March 18 , 2921:Fever 100.9,9:40 p.m. Chills 11:30 p.m., Fever 101.9, 12 a.m. Took 2 Tylenol March 19, 2021: Fatigue all day, sore arm getting worse, injection site getting redder and larger, hot to touch, Fever morning: 100.2, Fever afternoon 101.8. Sore all over body. Took 2 Tylenol in afternoon March 20, 2021: Fatigue until afternoon. Then mostly better. Fever 99.9. Injection site still very red and hot to touch
67 2021-03-20 tremor Hospitalized with the following. Fever, chills, nausea, shaking, vomiting
67 2021-03-24 burning sensation On day 11 post shot I started to feel mildly nauseated. Next day nausea increased, as did muscle ach... Read more
On day 11 post shot I started to feel mildly nauseated. Next day nausea increased, as did muscle aches and pain - by early evening I had repeated bouts of uncontrollable vomiting and uncontrollable diarrhea [no cramps, no warning] that lasted most of the night. I did have a fever briefly - got all red and felt like I was on fire - but that passed pretty quickly while the rest continued. I had to stay up all night, any attempt to lie down triggered more vomiting. By 3 in the morning I was ?on empty? and by 6 am could lie down. Nausea took three more days to leave completely. Muscle pain is resolving, almost gone. I am resuming my meds [everything that went down before came right back up]. The only tummy pain was after hours of vomiting [muscle strain]. Today is the 25th and I?m still tired and a bit foggy but otherwise feel better. I had a call with my doctor about this and she said I should report it so that?s what I?m doing.
67 2021-03-24 tingling fever, thickness in head, tingling in hand
67 2021-03-24 seizure like phenomena, weakness, cold sweat, tremor Prior to vaccination, the patient stated that she was nervous, but seemed relieved and okay directly... Read more
Prior to vaccination, the patient stated that she was nervous, but seemed relieved and okay directly following the vaccination. Following vaccination, patient became restless during the 15 minute post-vaccination window about 2-5 minutes after receiving the vaccine. She initially presented with uncontrollable shaking/bouncing legs, palpitation, sweating, and shortness of breath (though this was very brief. Patient remained coherent and oriented to time/person/place. The shaking and palpitations subsided after a couple minutes and resumed towards the end of the 15 minute waiting period, accompanied by nausea. 25 minutes post-vaccination she appeared to have stabilized, and we assisted the patient to her room nearby at her request to allow her to lie down while being monitored. After returning to her room, she very quickly ran to her sink due to her nausea, then after a minute of attempting to vomit, she collapsed and appeared to have briefly lost consciousness. EMS was called and the patient was rolled onto her side to prevent choking in the event of emesis. Patient remained responsive, but was weak and clammy with a weak pulse and breathing. After the firefighters came, a search of the apartment found the previously listed medications. Additionally, the patient experienced a seizure-like episode lasting 15 seconds in duration. Once the EMT came, they assessed her and monitored her in the ambulance; they reported that her condition appeared stable, her vitals were strong, and transported her to Hospital for observation/testing.
67 2021-03-26 cold extremities I got the vaccine at 11:30 a.m. About 8:30 p.m., I started to feel achy. At 9:30 p.m. I felt real... Read more
I got the vaccine at 11:30 a.m. About 8:30 p.m., I started to feel achy. At 9:30 p.m. I felt really achy. At 10:00 p.m. I had slight chills, and my hands felt colder than I had ever felt them before. At 10:30 p.m., I felt slightly nauseous. I went to bed then. When I woke up the next morning about 7:30 a.m., my body felt fine, but my brain was a bit foggy. This continued until about 12:00 p.m. After that, I was fine.
67 2021-03-26 tremor, migraine Started with a runny nose next day, 3rd day had Severe migraine on the right side of the head with b... Read more
Started with a runny nose next day, 3rd day had Severe migraine on the right side of the head with blurred vision and eye pain, light sensitivity and swelling of face, the base of the neck and at the site of injection and behind shoulderblade, Numbness of lips and burning mouth, Ongoing nausea, and upset gastrointestinal issues. Low-grade fever and chills, tremors in both arms and hands, upset stomach Still have nausea and headache, body pains,, tremors, and strong fatigue. issues
67 2021-03-31 night sweats 3/11/21: 11:05 AM - Pressure in chest lasting 8 hours; 9:00 PM- chest pressure gone, body chills b... Read more
3/11/21: 11:05 AM - Pressure in chest lasting 8 hours; 9:00 PM- chest pressure gone, body chills began; 12:30 AM - fever of 101.3 F; loss of appetite 3/12/21: 8:30 AM - Fever reduced to 99.5 F (no treatment taken) ; attempted normal daily activities; loss of appetite; 6:30 PM- extreme fatigue and dizziness, no appetite, slept 12 hours with night sweats 3/13/21: 8:30 AM -Fever gone, sweats gone; extreme fatigue lasting 24 hours; no appetite 3/14/21: 8:30 AM - Appetite returning, still tired, but functioning some daily routines; slept 12 hours 3/15/21: 8:30 AM - Appetite returned, normal daily activities achieved
67 2021-04-01 feeling cold Heart rate increased within 5 minutes of having the shot, went from 72 to 114. My heart rate staye... Read more
Heart rate increased within 5 minutes of having the shot, went from 72 to 114. My heart rate stayed at 109 or more until 10 PM the next night when its slowly went down to a normal heart rate. At 3 am (12 hours after the shot) i had a blinding debilitating headache that lasted until 9pm the next night. It also affected my vision. The headache was so bad i could not concentrate on the simplest task. I was unsure of what i could take for the headache. So, I did not take anything. When i woke up i was very tired and this lasted until the following day. 6am i had a fever of 102.3 this went down to 100.4 at 9:15 pm that night. I also had chills for several hours. 9:20 AM the nausea started followed by vomiting and dizziness. This only lasted for a few hours. I experienced very vivid dreams the night of the shot. I only drank some coconut water all day and could not eat any food. The next day Saturday March 27 i felt better but the fatigue did not go away until late in the evening. Sleeping seemed to help but i could only sleep for 2- 3 hours at the most.
67 2021-04-05 pain in extremity, tingling, muscle spasms, numbness, burning sensation 11:05 injection-burning sensation at site, assumed to be normal, sat down, within 17 min. top of ha... Read more
11:05 injection-burning sensation at site, assumed to be normal, sat down, within 17 min. top of hand began to prickle. Drawing cramping pain followed in forearm, prickling turned to numbness. Mentioned this to one attendant, who recommended sitting longer. Sensations continued, another nurse/attendant checked on me, also mentioned I sit at least 30 min. All other sensations normal-no nausea, no headache, etc. Small finger, finger next to it,-and their part of the hand to the wrist -were first numb, with occasional tingles, now still numb.[7:30 pm.] Slight cramp from top of arm to neck, is off -and- on from injection wait-time til now. I left at 11:55, took temperature at 12:20, =99.4 (my usual basal is 97.6).
67 2021-04-08 weakness, burning sensation Shortness of breath, hypertension, hypoxia, tachycardia, lips and fingers turn blue, high fever, ras... Read more
Shortness of breath, hypertension, hypoxia, tachycardia, lips and fingers turn blue, high fever, rash, hives, joint pain, whole body aches, left lower leg burning, artery blockages, infection, weakness, dizziness, tunnel vision, sweating, headache, new onset atrial fibrillation with rvr All of the above symptoms first occurred 30 minutes after injection of vaccine The atrial fibrillation occurred 6 days after injection Left lower leg started burning 15 days after injection The artial blockages and thrombus 18 days after injection by medical diagnosis due to instantaneous shut off of blood to left leg
67 2021-04-08 weakness About an hour after having the shot, I was nauseous, dizzy and light headed, I thought I was going t... Read more
About an hour after having the shot, I was nauseous, dizzy and light headed, I thought I was going to pass out. I had to lay down. My eyes swelled and they started to tear up, I felt weak all day and into the evening. I never had a bad reaction to a vaccine before, so this was surprising. I contacted the health department as they came to my house and gave me the shot, but I could not get through to anyone. I had to leave a message. After I was contacted back, I was told that someone would contact me that very same day, but no one ever did that day or any other day. .Because of that, I thought it must not have been a big deal, but after reading today that people in a specific had some of the same reactions I did, I thought I should report it.
67 2021-04-11 muscle spasms I went to bed and I felt OK I woke up about 1 o?clock and my head was exploring my body was aching a... Read more
I went to bed and I felt OK I woke up about 1 o?clock and my head was exploring my body was aching and I was so thirsty I can?t explain it so I got up and I drank a bunch of water and seltzer I didn?t really want to take the Advil at that point because I had nothing in my stomach I just wanted to get back in bed. My legs kept cramping up because I was sweating so much I guess I was dehydrated this went on at three and then again at five. I finally got up at five and I took a piece of bread and two Advil drank some more water finally starting to feel better it was like having the virus all over again but much milder
67 2021-04-11 unresponsive to stimuli Patient passed out and unresponsive and brought to hospital > 24 hours after vaccine given
67 2021-04-12 breast pain extreme breast pain, like a knife stabbing my breasts. piercing pain, more so in left breast- side ... Read more
extreme breast pain, like a knife stabbing my breasts. piercing pain, more so in left breast- side of injection. was relived with time and advil
67 2021-04-12 slurring, tremor Patient with racing heart, trembling within 15 minutes. Blood pressure checked and result was 131/6... Read more
Patient with racing heart, trembling within 15 minutes. Blood pressure checked and result was 131/61. Patient complained of dry mouth and Benadryl administered. Patient continued to be monitored and within 5 minutes following Benadryl, heart continues to race, chest heaviness, trembling hands, tongue numbness, tongue swelling, slowness of speech and thought. EpiPen administered to Left thigh. Within 30 seconds, tongue numbness and swelling resolved. 911 was called and responded to check patient. Vitals and EKG were monitored. BP somewhat elevated due to epinephrine. EKG WNL. Patient did not go to hospital.
67 2021-04-12 hot flush Chest pain, hot flashes, swallowing legs, feet and eyes.
67 2021-04-12 muscle spasms About one week after my injection, I had severe cramping in left leg. On April 5th started with a co... Read more
About one week after my injection, I had severe cramping in left leg. On April 5th started with a couple of days with severe pain in tendons of right shoulder. The pain referred into the right neck and base of occiput. On April 7, 2021, I felt off then developed a severe, stabbing headache over my right eye referring back into the occiput. Was not steady on my feet. Did not eat dinner, went to bed. Felt tingling around my mouth, and my neck and shoulders were very tight. I debated about going to the hospital, but decided against it. Still have tightness on the right side of my neck into the occiput and right shoulder.
67 2021-04-13 weakness The patient received the vaccine on 3/31/2021. On 4/7/2021, patient developed weakness that continue... Read more
The patient received the vaccine on 3/31/2021. On 4/7/2021, patient developed weakness that continued until 4/14/2021. Patient also developed shortness of breath on 4/14/2021. The patient presented to the ER for weakness and shortness of breath. Patient had labwork, EKG, and an Xray. Troponin, BNP, and D-Dimer were elevated. Sodium was low. Chest xray showed congestive heart failure. Pt required intubation and then coded. Cardiac life saving procedures were started but the patient succumbed to death. Patient death pronounced per MD.
67 2021-04-13 tingling, feeling hot March 8th: After inj., floaters in eyes, slight dizziness, felt warm. Water given, observation by ... Read more
March 8th: After inj., floaters in eyes, slight dizziness, felt warm. Water given, observation by staff approx 30min. Nurse escorted me out of building for extra precautions. April 9th: Stomach cramping, headache left side. 400mg IBU taken. April 10th bi-lateral edema , lower legs, right sided headache. 400mg IBU taken and elevated legs. April 11th: slight stomach cramping returned, with excessive flatulence. April 12th: Tingling in lower legs, edema diminished.
67 2021-04-14 inability to speak 2 weeks 8 days after vaccine, patient suffered which sent pt to emergency room. Husband states she h... Read more
2 weeks 8 days after vaccine, patient suffered which sent pt to emergency room. Husband states she had a "blood clot" to brain with skull fracture and traumatic brain injury. Transferred to Medical Center, then to long term facility. Has not recovered to date. Husband states unable to speak or move.
67 2021-04-14 feeling cold, tremor Severe headaches, A little nausea, Upset stomach, Heart racing, and I think it made my diazepa... Read more
Severe headaches, A little nausea, Upset stomach, Heart racing, and I think it made my diazepam and the stuff I take for my restless legs stop working. As my tremors from the withdrawals I have from Valium I?ve gotten worse, and my doctor switched me to another medication for restless legs. Cold all the time.
67 2021-04-14 pain in extremity I experienced moderate pain in calves beginning evening of 3/18/21, & sporadically since then. I be... Read more
I experienced moderate pain in calves beginning evening of 3/18/21, & sporadically since then. I began having moderate lower abdominal pain on 3/19/21, lasting approximately 24 hrs.
67 2021-04-14 pain in extremity Severe left arm pain / throb at injection site since March 31, 2021. I have been wearing a pain pat... Read more
Severe left arm pain / throb at injection site since March 31, 2021. I have been wearing a pain patch to try and sleep at night. Will not subside.
67 2021-04-14 tingling, tremor, pain in extremity Strange odor a few minutes after injection, followed by bitter taste, then nausea and spaciness. Diz... Read more
Strange odor a few minutes after injection, followed by bitter taste, then nausea and spaciness. Dizzyness, with vision looking 2D and flat by 15 minutes. Told Pharmacist, of spaciness who said stay as long as I wanted. Left at 30 minute point, still spacy and nauseous. Spaciness ended by an hour with nausea off and on. Chest pain - began around 7pm, continued to expand in area of chest, sharp stabbing pain later, pain from just above left elbow to hand and tingling of fingers, pain lower left leg and tingling of left foot. Irregular heart rate at different times. Checked into emergency room at 11:00. IV inserted, placed on continual heart and oxygen monitors, EKGs, chest X-rays (2), blood tests (3). Admitted to hospital sometime during the night. Given IV medications to counteract IV contrast allergy. These medications caused full body shakes, eyesight auras and extreme nausea with gagging. Heart CT taken with IV contrast. Discharged around 3:00 PM.
67 2021-04-14 tingling I woke up on Sunday morning with tingling in my left arm from my shoulder to my fingertips and my ri... Read more
I woke up on Sunday morning with tingling in my left arm from my shoulder to my fingertips and my right leg by the shin area. My left ear was itchy and hot to the touch. I took half a Benedryl. I did a telemed visit with my MD about my arm. She ordered a STAT US of my left arm and prescribed me prednisone.
67 2021-04-14 tremor 4/15/21 Pt called stating that she has had some of the symptoms that everyone is talking about with ... Read more
4/15/21 Pt called stating that she has had some of the symptoms that everyone is talking about with the vaccine. She stated that Friday after her shot on Monday she had severe tremors, so bad it shook the car, and she went to the ER. They ordered an MRI without contrast and she is scheduled for an MRI with contrast soon. She cannot remember the date, but she began having blurry vision in her left eye. She went to her eye doctor and he stated she had an "eye stroke". She had injections in her eye today. I asked her to please call her primary physician as well and she agreed. I told her I was going to report her symptoms.
67 2021-04-15 discomfort, pain in extremity LETHARGIC; ARM PAIN/SORE ARM; FEVER; HURT WHEN WAS INJECTED; FELT HAVING FLU; FELT HEAVINESS; This s... Read more
LETHARGIC; ARM PAIN/SORE ARM; FEVER; HURT WHEN WAS INJECTED; FELT HAVING FLU; FELT HEAVINESS; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced felt having flu. On APR-2021, the subject experienced felt heaviness. Laboratory data included: Body temperature (NR: not provided) 99.5 F, 98 F. On 08-APR-2021, the subject experienced lethargic. On 08-APR-2021, the subject experienced arm pain/sore arm. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced hurt when was injected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, and fever on 11-APR-2021, had not recovered from arm pain/sore arm, and the outcome of felt having flu, felt heaviness and hurt when was injected was not reported. This report was non-serious.
67 2021-04-15 flushing HARD KNOT AT INJECTION SITE; FLUSHING; DIZZINESS; RED SWELLING AT INJECTION SITE; NAUSEA; This spont... Read more
HARD KNOT AT INJECTION SITE; FLUSHING; DIZZINESS; RED SWELLING AT INJECTION SITE; NAUSEA; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included non smoker, and non alcohol user.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced hard knot at injection site. On APR-2021, the subject experienced flushing. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced red swelling at injection site. On APR-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, hard knot at injection site, flushing, dizziness, and red swelling at injection site. This report was non-serious.
67 2021-04-15 tremor HEADACHE; BODY ACHES; FEVER; SHAKINESS/TREMBLING; CHILLS; NAUSEA; TIRED; This spontaneous report rec... Read more
HEADACHE; BODY ACHES; FEVER; SHAKINESS/TREMBLING; CHILLS; NAUSEA; TIRED; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 58.96 kilograms, and height was 158.49 centimeters. The patient's concurrent conditions included non alcoholic, and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no illicit drug usage. the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 10:25 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen. On 10-MAR-2021, the subject experienced shakiness/trembling. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 10-MAR-2021 22:48, the subject experienced body aches. On 10-MAR-2021 22:48, the subject experienced fever. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakiness/trembling, chills, fever, nausea, and tired on 12-MAR-2021, and the outcome of body aches and headache was not reported. This report was non-serious.
67 2021-04-18 pain in extremity KNEE PAIN; LEG PAIN AND PAIN IN THIGHS; PAIN IN CALVES; EXHAUSTED; CHILLS; JOINT PAIN; MUSCLE PAIN;... Read more
KNEE PAIN; LEG PAIN AND PAIN IN THIGHS; PAIN IN CALVES; EXHAUSTED; CHILLS; JOINT PAIN; MUSCLE PAIN; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included no health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced joint pain. On 08-APR-2021, the subject experienced muscle pain. On 08-APR-2021, the subject experienced extreme fatigue. On 08-APR-2021 19:00, the subject experienced exhausted. On 11-APR-2021, the subject experienced pain in calves. On 11-APR-2021, the subject experienced knee pain. On 11-APR-2021, the subject experienced leg pain and pain in thighs. On 12-APR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 08-APR-2021, and extreme fatigue, and exhausted on 10-APR-2021, and had not recovered from muscle pain, knee pain, leg pain and pain in thighs, pain in calves, and joint pain. This report was non-serious.
67 2021-04-18 tremor I began having chills and shakiness at about 7 PM. I could not warm up. Took a hot bath still coul... Read more
I began having chills and shakiness at about 7 PM. I could not warm up. Took a hot bath still could not get warm. Turned up my electric blank in bed and still could not warm up. Finally about 1 Am I got up and took an oral dose of Thera Warming Flu. It knocked out the chills immediately and I was finally able to sleep. I had no arm pain.
67 2021-04-20 tremor WHOLE BODY SHAKES; DIZZINESS; TROUBLE WALKING AND HAND TO WALK REAL SLOW; FEELING SICK; CHILLS/SHIVE... Read more
WHOLE BODY SHAKES; DIZZINESS; TROUBLE WALKING AND HAND TO WALK REAL SLOW; FEELING SICK; CHILLS/SHIVERS; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included pace maker, and concurrent conditions included arthritis, herniating disk in the lower back, and dyslexia.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 15:00, the subject experienced whole body shakes. On 08-APR-2021 15:00, the subject experienced dizziness. On 08-APR-2021 15:00, the subject experienced trouble walking and hand to walk real slow. On 08-APR-2021 15:00, the subject experienced feeling sick. On 08-APR-2021 15:00, the subject experienced chills/shivers. On 08-APR-2021 15:00, the subject experienced tiredness. On 08-APR-2021 15:00, the subject experienced headache. Treatment medications (dates unspecified) included: lorazepam, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body shakes, feeling sick, and headache, recovered with sequelae from chills/shivers, had not recovered from dizziness, and tiredness, and the outcome of trouble walking and hand to walk real slow was not reported. This report was non-serious.
67 2021-04-22 muscle spasms, numbness TOES NUMB RIGHT FOOT; NUMBNESS IN LEFT HAND; CRAMPING RIGHT HAND; CHILLS; SLEEPY; This spontaneous r... Read more
TOES NUMB RIGHT FOOT; NUMBNESS IN LEFT HAND; CRAMPING RIGHT HAND; CHILLS; SLEEPY; This spontaneous report received from a consumer concerned a 67 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced sleepy. On 08-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced cramping right hand. On 14-APR-2021, the subject experienced numbness in left hand. On 16-APR-2021, the subject experienced toes numb right foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy on 17-APR-2021, numbness in left hand on 14-APR-2021, cramping right hand on 13-APR-2021, and chills on 09-APR-2021, and had not recovered from toes numb right foot. This report was non-serious.
67 2021-04-23 restless legs syndrome, migraine RASH RESEMBLING A SUN BURN; DIARRHEA; BODY ACHE; CHILLS; FEVER; ASTHMA; RESTLESS LEG SYNDROME; MIGRA... Read more
RASH RESEMBLING A SUN BURN; DIARRHEA; BODY ACHE; CHILLS; FEVER; ASTHMA; RESTLESS LEG SYNDROME; MIGRANE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with cortisone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced asthma. On 08-MAR-2021, the subject experienced restless leg syndrome. On 08-MAR-2021, the subject experienced migrane. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced rash resembling a sun burn. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asthma, and migrane on 08-MAR-2021, and restless leg syndrome, body ache, and fever on 09-MAR-2021, had not recovered from rash resembling a sun burn, and diarrhea, and the outcome of chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
67 2021-04-25 numbness, facial pain PATIENT CALLED TODAY AND SPOKE WITH PHARMACIST AND TOLD THAT SHE HAVE RIGHT SIDE OF HEAD IS NUMB. PA... Read more
PATIENT CALLED TODAY AND SPOKE WITH PHARMACIST AND TOLD THAT SHE HAVE RIGHT SIDE OF HEAD IS NUMB. PAIN IN CHEEKBONE. EYES ARE SWALLON. PHARMACIST TOLD HER TO SEE HER PRIMAMARY DOCTOR AND CHECK OUT THESE SYMPTOMS.
67 2021-04-26 speech disorder, severe one side paralysis My sister suffered a massive stroke with blood clots. Totally paralyzed on right side and limited sp... Read more
My sister suffered a massive stroke with blood clots. Totally paralyzed on right side and limited speech. Unable to function on her own, receiving care at a Nursing Home
67 2021-04-27 weakness 101.2 fever for four days with weakness for two weeks - 14 days. Since then, I have had virus sympto... Read more
101.2 fever for four days with weakness for two weeks - 14 days. Since then, I have had virus symptoms every four or five days, such as aching joints, lethargy, muscle pain, and nausea that lasts about 48 hours each time. Then it clears up and I feel better for a few days, then it comes back. I haven't felt well since the shot.
67 2021-04-28 pain in extremity Injection site sore for about 5 days - then 5 days later shoulder became very sore and achy. Arm no... Read more
Injection site sore for about 5 days - then 5 days later shoulder became very sore and achy. Arm now aches continuously and is very weak. Mobility without pain is limited. Have not contacted my doctor yet - but will do so soon. No doctor visit planned yet. (Suspecting this is SIRVA????)
67 2021-05-04 weakness, pain in extremity DIZZY; RUN DOWN; FEVERISH; HEADACHE; WEAK; TIRED; SORE ARM; BRUISED ARM AT INJECTION SITE; This spon... Read more
DIZZY; RUN DOWN; FEVERISH; HEADACHE; WEAK; TIRED; SORE ARM; BRUISED ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus issues.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:30 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride for sinuses. On 07-APR-2021, the subject experienced bruised arm at injection site. On 07-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced weak. On 08-APR-2021, the subject experienced tired. On 01-MAY-2021, the subject experienced dizzy. On 01-MAY-2021, the subject experienced run down. On 01-MAY-2021, the subject experienced feverish. On 01-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from bruised arm at injection site, and sore arm on 09-APR-2021, and had not recovered from tired, feverish, dizzy, headache, run down, and weak. This report was non-serious. This case, from the same reporter is linked to.
67 2021-05-07 numbness, slurring, facial paralysis, mild one side paralysis 67 yo female with PMH of HTN, DM who has two days of left sided numbness that has progressed to left... Read more
67 yo female with PMH of HTN, DM who has two days of left sided numbness that has progressed to left hemiparesis and dysarthria in the setting of having received the Johnson and Johnson vaccine on Wednesday(48hours prior). Patient was found to have a right parietal multifocal parenchymal hemorrhage measuring 19x36x37mm and small right temporal lobe SAH. Subsequent CTA showed thrombosis of the superior sagittal sinus and the right frontoparietal cortical veins as well has nonocclusive thrombus of right transverse and sigmoid sinus. The patient was also noted to have focal seizure of mouth and tongue and was loaded with phosphenytoin. After discussing case with neurology, nuero IR, NSGY and family it was decided to transfer the patient to sunrise for close monitoring and consideration of cerebral venous sinus thrombectomy if she worsens. I had a long discussion with multiple sisters about the risks of anticoagulation with argatroban given the IPH but the necessity given the cerebral venous thrombosis. I also discussed that argatroban is not readily reversible and that heparin is contraindicated if there is concern about vaccine induced thrombotic thrombocytopenia due to possible PF4 ab related to HIT. The patients VITT modified 4T score is 4 and she is intermediate risk for this being VITT. #Right parietal IPH, right temporal SAH and Superior saggital sinus thrombosis with nonocclusive thrombus of right transverse and sigmoid sinus -concern for vaccine induced thrombotic thrombocytopenia given johnson and johnson vaccine 2 days prior -modified VITT 4T score of 4- intermediate -send fibrinogen, d dimer, consider IVIG 1gm/kg per day for two days if high dimer, low fibrinogen and falling platelets -will start argatroban, avoid heparin until HIT ab (PF4) is resulted, if HIT positive avoid heparin -neuro IR consulted for possible IR intervention if worsens -transfer accepted by sunrise ICU, appreciate transfer for IR evaluation -continue phosphenytoin -SBP goal <150 with nicardipine and esmolol gtts -monitor daily fibrinogen, dimer, coags #AKI- monitoring uop and cr, consider renal US if worsens #DM- ISS #HTN- nicardipine and esmolol gtts for SBP <150, target 140 Patient seen, examined, labs and imaging reviewed, agree with resident note
67 2021-05-08 pain in extremity, weakness Janssen COVID-19 Vaccine EAU Fever of 99.0 degrees for 2 days. Weakness and tired. Sore arm and join... Read more
Janssen COVID-19 Vaccine EAU Fever of 99.0 degrees for 2 days. Weakness and tired. Sore arm and joints.
67 2021-05-20 feeling hot, feeling cold, pain in extremity, burning sensation, tremor, weakness 5-3-2021: at 11:54 am got J&J Covid-19 vaccine at Pharmacy. No anaphylaxis or other severe reactions... Read more
5-3-2021: at 11:54 am got J&J Covid-19 vaccine at Pharmacy. No anaphylaxis or other severe reactions within first four hours. By 8:00 pm began feeling fatigued and generally warm. No nausea or vomiting. By 11:00 pm developed diffuse soreness of left deltoid at injection site, mild chilling, muscle aches, T 98.8. Then developed severe shaking chills and profuse sweating, generalized, systemic burning sensation, nausea, light-headedness. This reaction lasted through the night, about 8 hrs. I spent 5-4-2021 in bed, and started feeling a bit better by 7:00 pm. By the next day felt very weak, light-headed and tired, and a little short of breath with movement. By 5-8-2021 felt pretty much back to normal, but tired. Arm soreness resolved. Reported reaction to my MD.
67 2021-05-24 weakness, mild one side paralysis LEFT SIDED WEAKNESS; HEART PALPITATIONS; DIZZINESS AND FEELING FAINT; UNABLE TO LIFT LEGS TO GO UPST... Read more
LEFT SIDED WEAKNESS; HEART PALPITATIONS; DIZZINESS AND FEELING FAINT; UNABLE TO LIFT LEGS TO GO UPSTAIRS; FATIGUE; WEAKNESS; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on left deltoid 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the patient experienced dizziness, heart palpitations during weeding outside, had fatigue and was feeling faint. On 08-MAY-2021, the patient was also unable to lift legs to go upstairs. On 12-MAY-2021, the patient experienced left sided weakness. On 20-MAY-2021, the patient visited the emergency room or department for treatment of the events and this was the second time of weakness. On 20-MAY-2021, Laboratory data included: Blood test (NR: not provided) Not reported, computed tomography scan (NR: not provided) No stroke and no blood clot, Chest X-ray (NR: not provided) Not reported, electrocardiogram 12 lead (ECG) (NR: not provided) Not reported, Investigation (NR: not provided) Not reported, and Magnetic resonance imaging (NR: not provided) No stroke and no blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and had not recovered from left sided weakness, heart palpitations, dizziness and feeling faint, unable to lift legs to go upstairs, and weakness. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000180437.; Sender's Comments: V0:20210544480-Covid-19 vaccine ad26.cov2.s-Left sided weakness. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
67 2021-05-30 nerve pain, pain in extremity Plantar fasciitis severe Shooting pains in thighs, legs, feet (nerve pains)
67 2021-06-03 muscle spasms, migraine, discomfort Felt great @ post injection. 9pm took 2 Melatonin & drank small cup hot Sleepy Time tea.. Went to ... Read more
Felt great @ post injection. 9pm took 2 Melatonin & drank small cup hot Sleepy Time tea.. Went to bed. At 11:30 pm still not asleep. Restless & uncomfortable. 1:40 am woke up with terrible whole body muscle aches, sore belly, flatulence, gas, migraine-like headache, C5 & C6 neck pain, occasional leg cramping. Felt like I had the flu. Got out of bed & sat in recliner with quilt over me. After a bit started feeling a little better. Went back to bed @ 3 am. Still had a rough time getting back to sleep. Very uncomfortable. Got up @ 5am. Still have intense total-body aches, neck pain, headache, fever 100.1 Drinking a lot of water. Took 2 / 500mg Acetaminophen
67 2021-06-03 pain in extremity Janssen covid-19 vaccine EUA - side effects 1. head 'fog' 2. voracious hunger [i've NE:VER had ... Read more
Janssen covid-19 vaccine EUA - side effects 1. head 'fog' 2. voracious hunger [i've NE:VER had a flu vaccine] 21 hours in i'm still starving . what's the cure? 15 hours later I woke up at 6 a.m. because I was starving I had to make myself eggs and toast. 17 hours " I had a bagel. 18 hours " I made meatballs I was eating them like candy. [albeit my meatballs are delish carmelized onions, roasted garlic, basil, pesto...yum] I feel drugged. [ it's like a trip from the 70s flashback]. I feel weird. closest thing is dizzy but not dizzy just weird, very weird. head/brain fuzzy . The munchies continue. I never heard of these side effects before we'll see how long they last. only a pale yellow bruise where the injection went in. minimal arm soreness if any , no rash. I got a 12-page booklet for taking the vaccine yesterday I'm going to report the symptoms to the CDC, Johnson & Johnson janssen and whoever else wants to hear about them there's a big long list in the pamphlet they gave me. Maybe there's a cure. I hope it doesn't last too long I'll run out of food. 6 hours later I've got the munchies I'm eating everything in sight for dinner I had soup, two salad,s a steak, dessert and pretzels. I've never eaten that much ever. 4 hours down I started getting super hungry but I thought it was cuz I barely ate breakfast and lunch cuz I didn't know how this was going to react. I still don't feel a thing in the arm. yay hope it sticks. I can't even see where they gave me the shot. I will admit the shot did hurt a little when it went in, I don't know if it's cuz she pushed the plunger fast, or if it was cold from the refrigerator or what but I definitely felt a little something with it going in but not since. I realized that when I went into the hospital out building to get the vaccine I was talking to the nurse for a while because they had to go get my vaccine and she was telling me that three of her family members got the Johnson & Johnson and they didn't feel a thing, no sore arm no fever no nothing so I'm hoping that subliminally I absorbed that and that's why I'm having such a favorable results cuz I think I was really expecting something or other. Even though I know someone who got the jnj & didn't have a problem. I did my own research and nobody under 50 has had a problem and even those people had medical conditions and we're taking prescription drugs and so on which is not my case we'll see. The first hour has passed no rash, no soreness of arm nothing I'm a little bit surprised happily.
67 2021-06-08 tremor I suffered an eye stroke and tremors I went to my eye dr for a check on my right eye and told him I ... Read more
I suffered an eye stroke and tremors I went to my eye dr for a check on my right eye and told him I had very if little sight in my left eye they ran tests and my dr said I had an eye stroke I been in his office approximately 14 days earlier befythe bust when he found the eye stoke my left eye was perfectly fine then Before going to the eye dr I devoted really bad tremors and I had several tests to see what caused it it has mostly went away I still have tremors aliitte
67 2021-06-14 pain in extremity TEETH WERE BLUE THAT HAD FILLINGS; HAIR LOSS; FATIGUE; DIFFICULTY FUNCTIONING; RACING HEART; BLURRED... Read more
TEETH WERE BLUE THAT HAD FILLINGS; HAIR LOSS; FATIGUE; DIFFICULTY FUNCTIONING; RACING HEART; BLURRED VISION; SHORTNESS OF BREATH; SLICK FINGERS; LACEY RASH TO ARMS, HANDS, LEGS, AND CHEST; SEVERE HEADACHES; CHILLS; RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast surgery, tonsillectomy, pulled chest wall muscle, rib separation, and eye surgery, and concurrent conditions included penicillin allergy, environmental allergies, and atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced right arm pain. On 08-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced severe headaches. On 15-APR-2021, the subject experienced lacey rash to arms, hands, legs, and chest. On 18-APR-2021, the subject experienced blurred vision. On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced slick fingers. On 20-APR-2021, the subject experienced racing heart. On 25-APR-2021, the subject experienced difficulty functioning. On 25-APR-2021, the subject experienced fatigue. On 01-MAY-2021, the subject experienced hair loss. On 10-MAY-2021, Laboratory data included: C-reactive protein (NR: not provided) Elevated, and Sonogram (NR: not provided) normal. On 24-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Thyroid function test (NR: not provided) Normal. On 03-JUN-2021, the subject experienced teeth were blue that had fillings. On 08-JUN-2021, Laboratory data included: C-reactive protein (NR: not provided) Normal, and Complete blood count (NR: not provided) Normal. On 09-JUN-2021, Laboratory data included: Panoramic dental X-ray (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, difficulty functioning, and shortness of breath, right arm pain on 04-APR-2021, chills on 11-APR-2021, and severe headaches on 14-APR-2021, was recovering from lacey rash to arms, hands, legs, and chest, and fatigue, had not recovered from hair loss, teeth were blue that had fillings, and slick fingers, and the outcome of racing heart was not reported. This report was non-serious.
67 2021-06-15 weakness PROFUSE SWEATING; FELT LIKE I WANTED TO PASS OUT AND DIZZINESS; FEEL ICKY ALL OVER MY BODY AND FEELI... Read more
PROFUSE SWEATING; FELT LIKE I WANTED TO PASS OUT AND DIZZINESS; FEEL ICKY ALL OVER MY BODY AND FEELING CRAPPY; NO APPETITE; RACING HEART; DON'T FEEL WELL AND ILL ALL OVER; VERY WEAK; HEADACHES; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included severe nausea, and heart race, and concurrent conditions included depression, penicillin allergy, non alcohol user, and non smoker. The patient experienced drug allergy when treated with ciprofloxacin, erythromycin, and sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 06-JUN-2021 13:30 for prophylactic vaccination. Concomitant medications included citalopram for depression. On 06-JUN-2021, the subject experienced profuse sweating. On 06-JUN-2021, the subject experienced felt like i wanted to pass out and dizziness. On 06-JUN-2021, the subject experienced feel icky all over my body and feeling crappy. On 06-JUN-2021, the subject experienced no appetite. On 06-JUN-2021, the subject experienced racing heart. On 06-JUN-2021, the subject experienced don't feel well and ill all over. On 06-JUN-2021, the subject experienced very weak. On 06-JUN-2021, the subject experienced headaches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from profuse sweating, felt like i wanted to pass out and dizziness, racing heart, and headaches, and had not recovered from don't feel well and ill all over, very weak, feel icky all over my body and feeling crappy, and no appetite. This report was non-serious.
67 2021-06-22 pain in extremity Sore arm, swollen shoulder on the side where the shot was injected , flu like symptoms, no taste.
67 2021-06-28 pain in extremity RIGHT FOOT SWELLING; CAN'T PUT WEIGHT ON IT WITHOUT PAIN/FEEL LIKE CAN'T PUT WEIGHT ON FOOT; LUMP O... Read more
RIGHT FOOT SWELLING; CAN'T PUT WEIGHT ON IT WITHOUT PAIN/FEEL LIKE CAN'T PUT WEIGHT ON FOOT; LUMP ON TOP OF RIGHT FOOT, SLIGHTLY TO THE SIDE; CAN'T WALK; RIGHT FOOT PAIN; FEVER; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not seek medical attention. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021, the subject experienced fever. On 22-JUN-2021, the subject experienced right foot swelling. On 22-JUN-2021, the subject experienced can't put weight on it without pain/feel like can't put weight on foot. On 22-JUN-2021, the subject experienced lump on top of right foot, slightly to the side. On 22-JUN-2021, the subject experienced can't walk. On 22-JUN-2021, the subject experienced right foot pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 21-JUN-2021, and had not recovered from right foot pain, right foot swelling, can't put weight on it without pain/feel like can't put weight on foot, lump on top of right foot, slightly to the side, and can't walk. This report was non-serious.
67 2021-07-12 pain in extremity Severe pain in the arm muscle, followed by 3 days of headache, fever and intense pain in the arm, sh... Read more
Severe pain in the arm muscle, followed by 3 days of headache, fever and intense pain in the arm, shoulder and right hand with pain and swollen knuckles and fingers, up to the right lung. Immobility from pain, I took TYLENOL, the discomfort was passing but the pain in my arm remained. I put hot water every day and applied the arnica cream after bathing to reduce the pain that intensified at the end of June along with the shoulder. I went to the doctor, she prescribed ibuprofen 800. To withstand the pain and regain mobility. She order Physical Therapy I had 10 sessions with physical Therapy. It has improved but I still have pain in my arm although I still have not finished with the sessions.
67 2021-07-16 slurring SWOLLEN LIPS AND TONGUE; SLURRED SPEECH; This spontaneous report received from a patient concerned a... Read more
SWOLLEN LIPS AND TONGUE; SLURRED SPEECH; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 140 pounds, and height was 67 inches. The patient's concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included no abuse or illicit drug usage. The patient experienced anaphylactic reaction to morphine and drug allergy when treated with morphine, drug allergy when treated with codeine, lisinopril, hydrocodone bitartrate/paracetamol, and tramadol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced slurred speech. On 12-JUL-2021, the subject experienced swollen lips and tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slurred speech on JUL-2021, and was recovering from swollen lips and tongue. This report was non-serious.
67 2021-07-16 numbness NUMBNESS IN TOES IN THE RIGHT FOOT; This spontaneous report received from a patient concerned a 67 y... Read more
NUMBNESS IN TOES IN THE RIGHT FOOT; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included hypercholesterolemia, and concurrent conditions included hypothyroidism, hypersensitivity to bees wax, no alcohol use, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. family history of gout. she consumes biological food for about 40 years. The patient experienced drug allergy when treated with loracarbef. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced numbness in toes in the right foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in toes in the right foot. This report was non-serious.
67 2021-07-17 difficulty speaking Within 2 minutes of receiving vaccine funny sensation in my mouth Very mild Only lasted few minutes ... Read more
Within 2 minutes of receiving vaccine funny sensation in my mouth Very mild Only lasted few minutes never reported. Within 1 hour of receiving the vaccine numbness tip of my tongue. At around 0630 started with restlessness, sob, coughing which kept getting worse, stated losing my voice. Went to urgent care and given injection of solumedrol, and back to back doses of duo neb treatments Released. At 0400 next day started again with SOB, coughing, Resolved with duoneb treatment 4 to 5 hours later started again with SOB and coughing Resolved with duoneb treatment. No further episodes
67 2021-07-24 weakness, numbness I?m a neonatal nurse practitioner, I have a high pain threshold . I had Covid in January 2021 I am ... Read more
I?m a neonatal nurse practitioner, I have a high pain threshold . I had Covid in January 2021 I am a healthcare worker and did not seek medical treatment. This was not a normal reaction to a vaccine. Extreme headache Fever of 101° normal for me is 95.7- 97° Extreme joint pain, left hip still inflamed Sever chills, almost spasmodic, teeth chattering. Rigors Extreme Weakness Numb fingers and thumb on left hand Lymph node popped the size of a Cherry tomato
68 2021-03-09 weakness fever up to 102.3, headache, chills, nausea, dizziness, body aches, weakness
68 2021-03-09 muscle spasms fever, cramps, and fatigue
68 2021-03-12 pain in extremity On MON evening after the shot, at 11:00pm I experience severe chills that lasted for hours. Tuesday ... Read more
On MON evening after the shot, at 11:00pm I experience severe chills that lasted for hours. Tuesday morning I awoke with a bad headache and had body aches all day as well as tendonitis- like pain in both lower arms. I felt somewhat better on WED but I did notice that my compression sleeve on my right arm (lymphedema arm) felt more snug than usual. That night I had severe chills and fever of 101. I slept until 11:45am on THU and felt aches all over. Very fatigued. Went back to sleep from 2:00pm until 6:00pm. Temp was down to 99.8. When I woke and removed my compression garment, my arm was red and swollen, also rash-like bumps, and was very warm to the touch. FRI morning it looked worse, so I contacted my lymphedema specialist and then my PCP. This is NOT a good situation for anyone who has lymphedema and will necessitate months of treatment.
68 2021-03-16 pain in extremity Sore arm Brain fog Nauseous Joint pain Tired (very)
68 2021-03-17 pain in extremity pain in left back and neck that has expanded over a week to include left shoulder and left arm.
68 2021-03-18 feeling hot, feeling cold 0845 Vasovagal with strong retching - no emesis Initial VS: HR 50's O2 sat 85% Subsequent VS: 110/63... Read more
0845 Vasovagal with strong retching - no emesis Initial VS: HR 50's O2 sat 85% Subsequent VS: 110/63-HR 60-RR 20- O2 sat - 98% CBG 150 PMHx: HTN, HLD S: patient felt nauseated, dizzy, "hot all over", anxious O: Awake but unable to answer due to retching. Pale, diaphoretic, cool to touch. Cards: radial pulse thready - apical pulse in 50's RRR, no murmur. Resp: clear to auscultation. No cough or evidence of aspiration. GI: strong retching but no emesis. A/P: 68 y/o female who just rec'd J&J Covid Vaccine was in monitoring lot and found to be diaphoretic and retching - semi conscious.   Vasovagal response - patient recovered VS within 5 min of start of event. Wanted to go to hospital for evaluation. She was alone in her car. Called her dtr to apprise of situation. Authority parked her car and returned her car keys to her prior to transport to hospital.
68 2021-03-25 pain in extremity Janssen SARS-Covid-2 Vaccine Chills, fever, severe pain in left arm from shoulder to hand, body ach... Read more
Janssen SARS-Covid-2 Vaccine Chills, fever, severe pain in left arm from shoulder to hand, body ache, headache, flu like symptoms.
68 2021-04-01 tremor, pain in extremity She is on Hospice for her COPD. After she received the shot her leg and shoulder pain/ache increase... Read more
She is on Hospice for her COPD. After she received the shot her leg and shoulder pain/ache increased to an 8/10 (usually a 2-4/10) and was constant when it usually is intermittent. Her breathing is worse and she is maxing out her inhalers and needing many more doses of her rescue morphine than usual (usually 2.4 ml of 20mg/ml Roxanol used in a week and last week was 7.5ml). She has not been taking it for the pain for fear of med interactions. She has increased her Tylenol use from 500mg qd to 3000mg qd. Her tremors are worse and she is taking her propranolol for tremors 20mg BID instead of her usual 10mg BID. Her body sweats have gone from 1 time a week to 1-2 times a day. No fevers noted.
68 2021-04-02 hot flush, flushing Red flushing face, neck chest and arms. Felt like my face was on fire. It lasted maybe 30 minutes ... Read more
Red flushing face, neck chest and arms. Felt like my face was on fire. It lasted maybe 30 minutes and then started to go away on my arms, chest and neck. My face got better, but felt hot for maybe 2 hrs. after.
68 2021-04-04 pain in extremity NAUSEA; TIREDNESS; HEADACHE; TEMPERATURE 99 DEGREES; BODY ACHES; INJECTION SITE REDNESS; SORE ARM; T... Read more
NAUSEA; TIREDNESS; HEADACHE; TEMPERATURE 99 DEGREES; BODY ACHES; INJECTION SITE REDNESS; SORE ARM; This spontaneous report received from a vaccine facility concerned a 68 year old female. The patient's weight was 195 pounds, and height was 173.73 centimeters. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no history of drug abuse. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 07-MAR-2021 13:30 on left arm for prophylactic vaccination. Concomitant medications included atorvastatin for cholesterol, venlafaxine hydrochloride for hot flashes, colecalciferol for immune health, ascorbic acid/rosa canina/sodium ascorbate for immune support, and ascorbic acid/biotin/calcium pantothenate/choline bitartrate/colecalciferol/cyanocobalamin/dl-alpha tocopheryl acetate/folic acid/inositol/inulin/magnesium citrate/nicotinamide/pyridoxine hydrochloride/retinol palmitate/zinc citrate for overall health. On MAR-2021, the subject experienced sore arm. On 07-MAR-2021, the subject experienced injection site redness. On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 deg. On 08-MAR-2021 11:30, the subject experienced body aches. On 08-MAR-2021 11:30, the subject experienced nausea. On 08-MAR-2021 11:30, the subject experienced tiredness. On 08-MAR-2021 11:30, the subject experienced headache. On 08-MAR-2021 11:30, the subject experienced temperature 99 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, sore arm, injection site redness, nausea, tiredness, headache, and temperature 99 degrees on MAR-2021. This report was non-serious.
68 2021-04-07 weakness Seven hours after the shot (8:00 p.m.), I experienced chills. By 9:00 p.m. I felt weak and light he... Read more
Seven hours after the shot (8:00 p.m.), I experienced chills. By 9:00 p.m. I felt weak and light headed. Later in the evening, at approximately 11:00 p.m. I had a fever of 103.3. The fever lasted for about three hours or so. I took acetaminophen at 11:45 p.m. I also kept cold compresses on my forehead. I woke up at approximately 8:00 a.m. and felt much better. I had a mild headache and took more acetaminophen. By 11:00 a.m. I was back to normal.
68 2021-04-07 pain in extremity Dizzy, nausea, headache, very sore legs and hands, chills, fever., fatigue. The headache was the la... Read more
Dizzy, nausea, headache, very sore legs and hands, chills, fever., fatigue. The headache was the last to go, it lasted for 2 days.
68 2021-04-08 burning sensation Johnson Johnson one dose vaccine..I awoke at approximately 2am with burning sensation in both should... Read more
Johnson Johnson one dose vaccine..I awoke at approximately 2am with burning sensation in both shoulder and hip joints..it subsided within 30 minutes, however it was enough to startle me and wake me up.
68 2021-04-08 difficulty speaking 5 minutes after vaccine I felt a sharp pain in the middle of my head like a headache and thought it ... Read more
5 minutes after vaccine I felt a sharp pain in the middle of my head like a headache and thought it would go away and i got dizzier and dizzier for about 25 minutes, I started getting hoarse in my voice, and my heart rate went up.
68 2021-04-08 flushing Difficulty breathing, anxiety, flushed skin.
68 2021-04-09 tremor Pale, Sweating, Shaking Nausea gave water, cool compress and chocolate had patient stay seated for 3... Read more
Pale, Sweating, Shaking Nausea gave water, cool compress and chocolate had patient stay seated for 3- minutes then remain in store until feeling better Patient felt better and left of her own accord
68 2021-04-10 muscle spasms LEG CRAMPS; This spontaneous report received from a patient concerned a 68 year old female. The pati... Read more
LEG CRAMPS; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced leg cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg cramps on 04-APR-2021. This report was non-serious.
68 2021-04-12 weakness 4/08/2021 @1200 - diarrhea, tired, weak. At 1700, extreme muscle achiness. At 2300, severe headache... Read more
4/08/2021 @1200 - diarrhea, tired, weak. At 1700, extreme muscle achiness. At 2300, severe headache, temp 102° F, chills, sore mucous membranes in mouth, tachycardia (110-120/min), Respiratory expiratory wheezes. Took Tylenol extended release 650mg po. Drank grape juice & 7up. Diarrhea twice during night (4/09/2021) 0100 - 0600. Very sick. By 0700 on 4/09/2021 symptoms slightly better. Still had temp of 100 °F, O2 Saturation 94%, Took Tylenol every 6 hrs x 3 daily on 4/09/2021 thru 4/11/2021. Didn't feel better til 4/11/2021.
68 2021-04-12 migraine, pain in extremity 4/7 late night fever 100.5. Woke up around 3AM 4/8 feeling very dehydrated with migraine like heada... Read more
4/7 late night fever 100.5. Woke up around 3AM 4/8 feeling very dehydrated with migraine like headache pain which continued throughout that day with occasional bouts of vomiting. 4/9 headache and vomiting gone, just felt drained and tired. 4/7 and 4/8 in the early evening, I think around 7, also had odd waves of intense pain in left heel lasting 2-3 minutes.
68 2021-04-12 muscle spasms Developed throbbing type sensation in calf right leg. No warmth of extremity developed. Lasted 24 ho... Read more
Developed throbbing type sensation in calf right leg. No warmth of extremity developed. Lasted 24 hours then stopped. No residual discomfort at present time.
68 2021-04-12 pain in extremity Extreme soreness in left arm extending into the chest and back. Continued as of 3/13/2021
68 2021-04-13 weakness Fever, chills, body aches, upset stomach,headaches, dizziness, tired, week
68 2021-04-13 weakness Headache ringing ears, body aches 6 days current. Elevated temp z3 days Loss of energy
68 2021-04-13 difficulty speaking, pain in extremity Later the day after the vaccine I developed severe chills and a really bad sore throat. I developed... Read more
Later the day after the vaccine I developed severe chills and a really bad sore throat. I developed hives in my throat and mouth which cause hoarsness and was hurting really bad. On that Monday I visited my PCP who prescribed an antibiotic which did help and took antihistimines also. I developed a fever an was really tired and after about 3 day the symptoms subsided. My arm was really sore for about 2 days also.
68 2021-04-13 migraine On 3/21, 10 days post vaccine, I experienced ocular migraine with severe vertigo. Felt like I was g... Read more
On 3/21, 10 days post vaccine, I experienced ocular migraine with severe vertigo. Felt like I was going to pass out. Called 911 as I was alone at the time. BP was elevated..likely general anxiety. The vertigo subsided as did the ocular migraine but had slight headache the rest of the day. Notified my PCP.
68 2021-04-13 muscle spasms About two weeks later developed cramping in Left leg. Also has varicose veins. Had the cramping bef... Read more
About two weeks later developed cramping in Left leg. Also has varicose veins. Had the cramping before. No more cramping but feeling of tightness remains around the calf. Not hot, not red. but seems like the veins seemed red and now purple. Seem to have more spider veins. medial posterior part of calf below the knee. Didn't think anything about all this until heard about the news about the JnJ vaccine. Also had a different type of abdominal pain. Almost felt like she may be constipated but wasn't. Only lasted a few days. Has been unable to make an appointment with PCP until may 4th.
68 2021-04-15 migraine Experienced severe migraines on 4/4, 4/6, 4/8. PCP prescribed rizatriptan rapid dissolve 5 mg Tbdi.... Read more
Experienced severe migraines on 4/4, 4/6, 4/8. PCP prescribed rizatriptan rapid dissolve 5 mg Tbdi. Was able to take this medication on 4/9 when I felt another migraine coming on. It worked. The migraines on 4/4, 4/6, and 4/8 began with an aura which lasted more than an hour. The headaches were so severe that on 4/8 I had my son stay the night. I never experienced such intense pain in the past. I do have a history of migraines, but had not had one since 2016. Typically, I would get the aura, lay down and close my eyes, and then the aura would diminish in 15 - 30 minutes. I never get a headache with the auras.
68 2021-04-15 pain in extremity BODY ACHES; FLU LIKE SYMPTOMS; SLIGHT DIARRHEA BUT NOT BAD; FEELS LIKE SINUS INFECTION; FEELING BLAH... Read more
BODY ACHES; FLU LIKE SYMPTOMS; SLIGHT DIARRHEA BUT NOT BAD; FEELS LIKE SINUS INFECTION; FEELING BLAH; SORE ARM/MUSCLES; CHILLS THAT COME AND GO; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sarcoidosis autoimmune disease, arthritis, and arthritis pain. The patient experienced swelling around ankles when treated with felodipine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included paracetamol for arthritis pain. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced slight diarrhea but not bad. On 09-APR-2021, the subject experienced feels like sinus infection. On 09-APR-2021, the subject experienced feeling blah. On 09-APR-2021, the subject experienced sore arm/muscles. On 09-APR-2021, the subject experienced chills that come and go. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, flu like symptoms, chills that come and go, slight diarrhea but not bad, and sore arm/muscles, and the outcome of feels like sinus infection and feeling blah was not reported. This report was non-serious.
68 2021-04-15 tremor BONE PAIN; HARD TO SLEEP; BAD FLU; BOTH SIDES OF THE BACK HURT; SHAKING; HARD TO BREATH IN MIDDLE OF... Read more
BONE PAIN; HARD TO SLEEP; BAD FLU; BOTH SIDES OF THE BACK HURT; SHAKING; HARD TO BREATH IN MIDDLE OF THE NIGHT; BOWL MOVEMENT WAS VERY GROSS AND SMELLY; PAIN IN HIP; MUSCLE SORENESS; SLIGHT HEADACHE; FEVER; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood thinner, and stroke, and concurrent conditions included grass allergy, tree allergy, and yellow paint allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced bone pain. On 08-APR-2021, the subject experienced hard to sleep. On 08-APR-2021, the subject experienced bad flu. On 08-APR-2021, the subject experienced both sides of the back hurt. On 08-APR-2021, the subject experienced shaking. On 08-APR-2021, the subject experienced hard to breath in middle of the night. On 08-APR-2021, the subject experienced bowl movement was very gross and smelly. On 08-APR-2021, the subject experienced pain in hip. On 08-APR-2021, the subject experienced muscle soreness. On 08-APR-2021, the subject experienced slight headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache on 09-APR-2021, and fever, was recovering from muscle soreness, bone pain, bad flu, both sides of the back hurt, pain in hip, and hard to breath in middle of the night, had not recovered from shaking, and bowl movement was very gross and smelly, and the outcome of hard to sleep was not reported. This report was non-serious.
68 2021-04-16 speech disorder, tingling shoulder and neck tightness and soreness, tiredness lasting to the present date, weak arms, tingling... Read more
shoulder and neck tightness and soreness, tiredness lasting to the present date, weak arms, tingling in hands, poorer short term memory and speech, pain below directly below lower sternum
68 2021-04-18 pain in extremity Within first 12 hours, felt very tired, leg, back and shoulder muscles ached. Experienced on and off... Read more
Within first 12 hours, felt very tired, leg, back and shoulder muscles ached. Experienced on and off chills, low grade fever. Bad headache, dizziness and light headedness. All symptoms lasted 4 days. I handled this at home without medical intervention.
68 2021-04-19 tingling 1 week after injection experienced low platelet levels and bruising. Those resolved within another w... Read more
1 week after injection experienced low platelet levels and bruising. Those resolved within another week of time. Patient has also been more tired since vaccine, has been experiencing prolonged sinus issues and has been having sensations of needle pricking all over her body in various places since injection.
68 2021-04-21 weakness ZOMBIE LIKE; NO ENERGY; This spontaneous report received from a patient via a company representative... Read more
ZOMBIE LIKE; NO ENERGY; This spontaneous report received from a patient via a company representative concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dykinesia with parkinson's disease, covid-19, diverticulosis of intestine, opioid dependence, repeated fall, ventricular tachycardia, continuous positive airway pressure, and flopping like a fish. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included amantadine hydrochloride for dykinesia with parkinson's disease, carbidopa/entacapone/levodopa for dykinesia with parkinson's disease, carbidopa/levodopa for dykinesia with parkinson's disease, rotigotine for dykinesia with parkinson's disease, levodopa for dykinesia with parkinson's disease, and flopping like a fish, calcium, carvedilol, celecoxib, colecalciferol, entacapone, estradiol, ezetimibe, fluoxetine, gabapentin, hydrocodone, loratadine, mirabegron, nortriptyline, ramipril, tapentadol hydrochloride, and vitamin e nos. On 16-MAR-2021, the subject experienced zombie like. On 16-MAR-2021, the subject experienced no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from zombie like, and no energy on 20-MAR-2021. This report was non-serious.
68 2021-04-21 migraine STUFFY NOSE; DIARRHEA; FAECES HAS REALLY BAD ODOUR; MIGRAINE-LIKE HEADACHE; CHILLS; INJECTION SITE P... Read more
STUFFY NOSE; DIARRHEA; FAECES HAS REALLY BAD ODOUR; MIGRAINE-LIKE HEADACHE; CHILLS; INJECTION SITE PAIN; PRESSURE IN THE CHEST; RIGHT BREAST (FROM CENTER OF CHEST) UNDER THE ARMPIT STILL FEEL DISCOMFORT; HEART BEATING FASTER; FELT LIKE HEART WAS JUMPING OUT OF THE CHEST; STOMACH PAIN/SHARP PAIN; FELT THE URGE TO GO TO THE BATHROOM; REDNESS OF THE FACE; PAIN IN THE JAWS (BOTH SIDE); FELT LIKE HAVING A HEART ATTACK; PAIN SHOT UP TO RIGHT SIDE OF NECK TO SHOULDER AREA, THEN ELEVATED TO THE EARS; HARD TO BREATHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included x-ray dye allergy, prednisone allergy, amoxicillin allergy, non alcoholic, non smoker, fibromyalgia, and lymphedema in the legs, and other pre-existing medical conditions included the patient had allergy to an unspecified pain medication. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:15 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced pressure in the chest. On 10-APR-2021, the subject experienced right breast (from center of chest) under the armpit still feel discomfort. On 10-APR-2021, the subject experienced heart beating faster. On 10-APR-2021, the subject experienced felt like heart was jumping out of the chest. On 10-APR-2021, the subject experienced stomach pain/sharp pain. On 10-APR-2021, the subject experienced felt the urge to go to the bathroom. On 10-APR-2021, the subject experienced redness of the face. On 10-APR-2021, the subject experienced pain in the jaws (both side). On 10-APR-2021, the subject experienced felt like having a heart attack. On 10-APR-2021, the subject experienced pain shot up to right side of neck to shoulder area, then elevated to the ears. On 10-APR-2021, the subject experienced hard to breathe. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced injection site pain. On 10-APR-2021 13:00:00, the subject experienced migraine-like headache. On 13-APR-2021, the subject experienced stuffy nose. On 13-APR-2021, the subject experienced diarrhea. On 13-APR-2021, the subject experienced faeces has really bad odour. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart beating faster, and chills on APR-2021, redness of the face on 12-APR-2021, and pain in the jaws (both side) on 11-APR-2021, was recovering from migraine-like headache, pressure in the chest, and hard to breathe, had not recovered from stuffy nose, and diarrhea, and the outcome of stomach pain/sharp pain, injection site pain, felt like heart was jumping out of the chest, felt the urge to go to the bathroom, faeces has really bad odour, pain shot up to right side of neck to shoulder area, then elevated to the ears, felt like having a heart attack and right breast (from center of chest) under the armpit still feel discomfort was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
68 2021-04-21 pain in extremity SWOLLEN RIGHT PINKY FINGER; PAIN IN RIGHT ARM; SHIVERS; LOW GRADE HEADACHES; DARK DIARRHEA; SEVERE ... Read more
SWOLLEN RIGHT PINKY FINGER; PAIN IN RIGHT ARM; SHIVERS; LOW GRADE HEADACHES; DARK DIARRHEA; SEVERE STOMACH PAIN; DIFFICULTY SLEEPING; SWOLLEN STOMACH OR BLOATEDEDNESS; LETHARGIC; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was not reported and height was 59 inches. The patient's concurrent conditions included irritable bowel syndrome, and migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A2A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included linaclotide for irritable bowel syndrome, macrogol 3350 for irritable bowel syndrome, senna alexandrina for irritable bowel syndrome, simeticone for irritable bowel syndrome, sodium phosphate dibasic/sodium phosphate monobasic for irritable bowel syndrome, and acetylsalicylic acid/caffeine/paracetamol/salicylamide for migraine. On 09-APR-2021, the subject experienced dark diarrhea. On 09-APR-2021, the subject experienced severe stomach pain. On 09-APR-2021, the subject experienced difficulty sleeping. On 09-APR-2021, the subject experienced swollen stomach or bloatededness. On 09-APR-2021, the subject experienced lethargic. On 09-APR-2021, the subject experienced shivers. On 09-APR-2021, the subject experienced low grade headaches. On 12-APR-2021, the subject experienced swollen right pinky finger. On 12-APR-2021, the subject experienced pain in right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in right arm on 14-APR-2021, was recovering from dark diarrhea, and swollen stomach or bloatededness, had not recovered from swollen right pinky finger, severe stomach pain, and low grade headaches, and the outcome of difficulty sleeping, shivers and lethargic was not reported. This report was non-serious.
68 2021-04-22 numbness I have had constant headaches all week that do not go away even with ibuprofen. I also have numbnes... Read more
I have had constant headaches all week that do not go away even with ibuprofen. I also have numbness in my face and legs and last night during sleep my arm was numb and I was not laying on it. When I went to bed last night I had severe back pain. This has not gone away even with pain relievers.
68 2021-04-23 cold sweat, nerve pain, weakness EXTREME BREAK OUT OF COLD SWEAT; BEE STING-LIKE PAIN; NERVE PAIN; LOW BLOOD PRESSURE; IRRITABLE; RAS... Read more
EXTREME BREAK OUT OF COLD SWEAT; BEE STING-LIKE PAIN; NERVE PAIN; LOW BLOOD PRESSURE; IRRITABLE; RASH TROUGHOUT BODY; CHILLS; SWELLING AT SITE OF INJECTION; FEVER; NO STRENGTH TO STAND UP; ITCHING; BODY ACHES; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included sepsis, and concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 12:30, in the left arm, for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced no strength to stand up. On 18-MAR-2021, the subject experienced extreme break out of cold sweat. On 18-MAR-2021, the subject experienced bee sting-like pain. On 18-MAR-2021, the subject experienced nerve pain. On 18-MAR-2021, the subject experienced low blood pressure. On 18-MAR-2021, the subject experienced irritable. On 18-MAR-2021, the subject experienced rash throughout body. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced swelling at site of injection. On 18-MAR-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) Low. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 19-MAR-2021, had not recovered from extreme break out of cold sweat, chills, low blood pressure, swelling at site of injection, rash throughout body, bee sting-like pain, nerve pain, and irritable, and the outcome of itching, no strength to stand up and body aches was not reported. This report was non-serious.
68 2021-04-23 tremor, pain in extremity BODY ACHES / PAIN; SHAKES / SHAKING; SHIVERING; HEADACHE; NOT FEELING WELL / FEELING OFF; SHOULDERS ... Read more
BODY ACHES / PAIN; SHAKES / SHAKING; SHIVERING; HEADACHE; NOT FEELING WELL / FEELING OFF; SHOULDERS GOT TIGHT; LOWER BACK ACHE; ACHE IN HIP; LEGS HURT/ SORENESS IN ARM; FEVER / TEMPERATURE; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 99 pounds, and height was 66 inches. The patient's concurrent conditions included penicillin allergy, asthma, and trigeminal neuralgia, and other pre-existing medical conditions included type o positive blood. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 10:00 to left arm for prophylactic vaccination. Concomitant medications included gabapentin for trigeminal neuralgia, ergocalciferol, and vitamin b12 nos. On 10-MAR-2021, the subject experienced shoulders got tight. On 10-MAR-2021, the subject experienced lower back ache. On 10-MAR-2021, the subject experienced ache in hip. On 10-MAR-2021, the subject experienced legs hurt/ soreness in arm. On 10-MAR-2021, the subject experienced fever / temperature. On 10-MAR-2021 10:00, Laboratory data included: Body temperature (NR: not provided) 102.6 F. On 10-MAR-2021 16:00, the subject experienced not feeling well / feeling off. On 10-MAR-2021 18:00, the subject experienced shakes / shaking. On 10-MAR-2021 18:00, the subject experienced shivering. On 10-MAR-2021 18:00, the subject experienced headache. On 10-MAR-2021 18:30, the subject experienced body aches / pain. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97.2 F. On 11-MAR-2021 01:00, Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 11-MAR-2021 05:00, Laboratory data included: Body temperature (NR: not provided) 101.6F F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes / shaking, and shivering on 10-MAR-2021, body aches / pain, not feeling well / feeling off, and fever / temperature on 11-MAR-2021, and headache on 11-MAR-2021 10:00, was recovering from ache in hip, lower back ache, and legs hurt/ soreness in arm, and the outcome of shoulders got tight was not reported. This report was non-serious.
68 2021-04-24 tremor ON 4/25/21, PT STOPPED AT PHARMACY COMPLAINING OF ADVERSE REACTIONS SHE WAS HAVING DUE TO THE JOHNSO... Read more
ON 4/25/21, PT STOPPED AT PHARMACY COMPLAINING OF ADVERSE REACTIONS SHE WAS HAVING DUE TO THE JOHNSON AND JOHNSON VACCINE SHE GOT. SHE C/O NAUSEA AND HANDS SHAKING. I TOLD HER I WOULD SUBMIT A REPORTAND FOR HER TO SEEK TREATMENT FROM HER PCP. I ASKED THAT SHE CONTACT ME WITH ANY CONCERNS OR SHARE COMMENTS THAT DR SHARES WITH HER.
68 2021-04-25 burning sensation Pt has complained of intermittent burning sensation in ankles and wrist x 2 months since injection.
68 2021-04-26 tremor FEELING INTENSE DEBILITATING PAIN AROUND LOWER STOMACH AND GROIN AREA ON RIGHT SIDE; NEW TREMOR IN H... Read more
FEELING INTENSE DEBILITATING PAIN AROUND LOWER STOMACH AND GROIN AREA ON RIGHT SIDE; NEW TREMOR IN HANDS; THOUGHTS JUMBLING; INTERRUPT SLEEP; UNABLE TO EXERCISE; TERRIBLE HEADACHE; TERRIBLE VOMITING; COULD TAKE NO FOOD OR MEDICATION AT ALL; INTENSE VOMITING IT CAUSED TO LOSE CONTROL OF BLADDER; This spontaneous report received from a patient via a company representative concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included dental implants, and concurrent conditions included malignant neoplasm of right kidney except renal pelvis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included axitinib, and ondansetron. On MAR-2021, the subject experienced intense vomiting it caused to lose control of bladder. On 10-MAR-2021, the subject experienced terrible vomiting. On 10-MAR-2021, the subject experienced could take no food or medication at all. On an unspecified date, the subject experienced feeling intense debilitating pain around lower stomach and groin area on right side, new tremor in hands, thoughts jumbling, interrupt sleep, unable to exercise, and terrible headache. Treatment medications (dates unspecified) included: naproxen, and codeine phosphate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible vomiting, could take no food or medication at all, and intense vomiting it caused to lose control of bladder on 2021, and the outcome of feeling intense debilitating pain around lower stomach and groin area on right side, new tremor in hands, terrible headache, thoughts jumbling, interrupt sleep and unable to exercise was not reported. This report was non-serious.
68 2021-04-27 numbness numbness in my right leg the night of the vaccine, a mineral or metallic taste in my mouth for a few... Read more
numbness in my right leg the night of the vaccine, a mineral or metallic taste in my mouth for a few hours after receiving the vaccine. Also severe diarrhea started around midnight the night of the vaccine and did not clear up until March13.
68 2021-04-27 numbness On 4/7/21 I was extremely fatigue and had numbness on my left side. I never had any issues before ge... Read more
On 4/7/21 I was extremely fatigue and had numbness on my left side. I never had any issues before getting vaccinated.
68 2021-04-27 muscle spasms, involuntary muscle movements, numbness, tingling TINGLING ALL OVER; WEIRD FEELING LIKE NUMBNESS; JERKY LEGS; FEET FEELING LIKE CRAMPING UP WITH CHAR... Read more
TINGLING ALL OVER; WEIRD FEELING LIKE NUMBNESS; JERKY LEGS; FEET FEELING LIKE CRAMPING UP WITH CHARLIE HORSE; WEIRD FEELING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 113 pounds, and height was not reported. The patient's concurrent conditions included penicillin allergy, and sulfonamide allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced weird feeling in hands and feet. On 12-APR-2021, the subject experienced not quite pins and needles. On 12-APR-2021, the subject experienced tingling all over. On 12-APR-2021, the subject experienced weird feeling like numbness. On 12-APR-2021, the subject experienced jerky legs. On 12-APR-2021, the subject experienced feet feeling like cramping up with charlie horse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling all over, weird feeling like numbness, jerky legs, feet feeling like cramping up with charlie horse, weird feeling in hands and feet, and not quite pins and needles. This report was non-serious. This case, from the same reporter.
68 2021-05-03 discomfort (1) Approximately one month after vaccine, swelling in the muscle behind my left leg. I went to my P... Read more
(1) Approximately one month after vaccine, swelling in the muscle behind my left leg. I went to my Primary Care doctor, he examined my leg and immediately sent me to hospital ER because he was concerned that it might be a blood clot. They performed an ultrasound, but the results were negative and showed no signs of any blood clots. (2) Approximately three weeks after vaccine, I developed stiffness on the left side of my body in my arm, thigh and hip area. The stiffness was intense, uncomfortable and bothersome enough for me to take Tylenol for the pain the next 5 days and it lasted for about a week.
68 2021-05-03 muscle spasms, numbness Leg Cramps/ Numbed/ Unable to walk Headaches Antibodies blood test yielded negative/low antibodies U... Read more
Leg Cramps/ Numbed/ Unable to walk Headaches Antibodies blood test yielded negative/low antibodies Ultra sound results pending
68 2021-05-03 pain in extremity Stated her arm never stopped hurting and she couldn't move it
68 2021-05-09 muscle spasms Nausea, cramping, HA, visual changes, now ongoing for 4 weeks.
68 2021-05-14 hot flush I?ve been having extreme hot flashes/sweats upon the slightest exertion ie; walk, after taking showe... Read more
I?ve been having extreme hot flashes/sweats upon the slightest exertion ie; walk, after taking shower. I have to sit for awhile until it subsides or in front of a fan. I have been through menopause years ago so these are not from that. I have not sought a doctors advice as of now. I am hoping this problem goes away.......
68 2021-05-17 speech disorder Pt said that on the day following the vaccine she felt very dizzy and kept blacking out. Her husban... Read more
Pt said that on the day following the vaccine she felt very dizzy and kept blacking out. Her husband said that she was also mumbling nonsensical things, and started drooling. Today when she called, she had trouble with speaking and she is still drooling. Client suspects that she might have had a stroke or a blood clot, but she have not gone to the doctor because she does not have health insurance.
68 2021-05-19 hot flush I have a major history of blood clots Muscle Aches Im never real chill was unable to get warm Ras... Read more
I have a major history of blood clots Muscle Aches Im never real chill was unable to get warm Rash on half my body Tired When I ate I felt a flushing feeling I felt like a pile of crap But it has lighten up Still dealing with core temperature problem, still cold
68 2021-05-19 pain in extremity SWOLLEN AREA BELOW THE SHOT/ SWELLING IN ARM; REDNESS IN PROXIMITY OF INJECTION SITE; SORE ARM; HEAR... Read more
SWOLLEN AREA BELOW THE SHOT/ SWELLING IN ARM; REDNESS IN PROXIMITY OF INJECTION SITE; SORE ARM; HEART FLUTTER; This spontaneous report received from a patient concerned a 68 year old White (Not Hispanic or Latino) female. The patient's height, and weight were not reported. The patient's past medical history included heart murmur, heart flutter, and severe hives with antibiotics, and concurrent conditions included non-alcoholic, non-smoker, sulfer allergy, and penicillin allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with azithromycin, cefdinir, and ibuprofen. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 30-APR-2021 on left arm as prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the patient experienced heart flutter. On 01-MAY-2021, the patient experienced sore arm. On 15-MAY-2021, the patient experienced swollen area below the shot/swelling in arm. On 15-MAY-2021, the patient experienced redness in proximity of injection site. The action taken with covid-19 vaccine was not applicable. The patient recovered from heart flutter on 30-APR-2021, and had not recovered from sore arm, swollen area below the shot/swelling in arm, and redness in proximity of injection site. This report was serious (Other Medically Important Condition).; Sender's Comments: Covid-19 vaccine heart flutter. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
68 2021-05-20 pain in extremity Immediate & 1st hour: dizziness & sore arm; all day off & on: hiccups & slight headache
68 2021-05-23 tingling, numbness Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Tingling sensatio... Read more
Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Tingling sensation from back down to feet
68 2021-05-25 weakness fierce "flu like" symptoms onset approx 6-8 hours post-injection; too ill to rise from prone positio... Read more
fierce "flu like" symptoms onset approx 6-8 hours post-injection; too ill to rise from prone position for 8+ hours, insomnia and breathing difficulties throughout, violent vomiting ("dry" heaving). Slow restoration of strength, gastric upset for 60 hours (initial severe diarrhea, stomach upset). Since then (15 days) weakness, malaise, persistent minor headache.
68 2021-05-27 pain in extremity Initially on vaccine evening 3/19/21 mild sore arm, mild brain fog, following day03/20/2021 heada... Read more
Initially on vaccine evening 3/19/21 mild sore arm, mild brain fog, following day03/20/2021 headache, tired, second day post vaccine 03/21/2021 no noticeable symptoms . 03/17/2021 first notation of headache,, 03/18/2021 headache continued all day ,03/19,2021 notation of headache setting in early evening , 03/20/2021 notation of tiredness all day accompanied by headache and achy everywhere-joints-muscles. Days following had notation of mild headache/body aches. 04/01/2021-8:30am Extremely Dizzy upon getting out of bed, Strong Panic attack-symptoms subsided with am medications, and reappeared about 11:00am. Strong Panic attack, very dizzy, neck stiff,muscle tightness in shoulders, sysmptoms continued off and on
68 2021-05-27 tingling, numbness About 1 hour after the vaccine I had tingling and numbness in the left side of my face. It lasted ab... Read more
About 1 hour after the vaccine I had tingling and numbness in the left side of my face. It lasted about 30 minutes and came back intermittently for several days. The morning after I received the vaccine I had a noticeable ringing in my ears when I woke. It lessened and went away after several hours but has been present most mornings since and has lessened and then stopped as the day progressed. Today (5/28) was not present when I woke but suddenly started again about 5:00 pm.
68 2021-05-30 burning sensation, electric shock sensation Headaches began Monday after vaccine. Burning on outside of brain 2 days. Headaches became severe he... Read more
Headaches began Monday after vaccine. Burning on outside of brain 2 days. Headaches became severe head pain which moved around. Several times ice pick like feeling in stomach. Felt like brain was shaking or vibrating. That lasted almost two weeks. At the end of that time electrical shocks firing randomly throughout my brain. Severe fatigue daily. Had to fall into bed and sleep for three hours daily during the severe symptoms. Now headaches daily but pain much less. Mostly on left side of head and behind left eye. Lesser fatigue but still there. Has affected quality of life.
68 2021-05-31 nerve pain I had no pain at injection spot but I did have a severe headache shortly after injection and had to... Read more
I had no pain at injection spot but I did have a severe headache shortly after injection and had to lay down at home and was in pain for six hours. I also experienced fatigue. I got out of bed in the evening and ate dinner. Then I returned to bed due to fatigue and severe nerve pain, joint pain, and all-over body pain. The second day I still felt lousy. The third day I felt OK.
68 2021-06-01 pain in extremity FATIGUE; LOOSER STOOL THAN NORMAL; SORE ARM; This spontaneous report received from a patient concern... Read more
FATIGUE; LOOSER STOOL THAN NORMAL; SORE ARM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816027, and batch number: 1816027 expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced looser stool than normal. On 25-MAY-2021, the subject experienced sore arm. On 27-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from fatigue on 28-MAY-2021, and had not recovered from looser stool than normal, and sore arm. This report was non-serious.
68 2021-06-02 mild one side paralysis Patient is a 69 year old female who was admitted on 5/27/2021 for CEREBRAL VENOUS SINUS THROMBOSIS. ... Read more
Patient is a 69 year old female who was admitted on 5/27/2021 for CEREBRAL VENOUS SINUS THROMBOSIS. Patient is a 69 year old female "who lives at home with husband. Patient with a h/o DM2, hyperlipidemia, epilepsy followed by Dr. neurology outpatient, hypertension. Patient on keppra and tegretol with some episodes of partial seizures, sensitive to being off medications. Patient was in usual state of health until today. Daughter noticed around 6 PM patient was confused, altered, dizzy, not able to walk, and had left arm weakness. The patient's sister had a stroke in the past and they were concerned for this and so brought her in for evaluation when she didn't improve. Daughter thinks patient might have started having symptoms around 1 PM. Daughter reports patient was not taking her aspirin, and they never picked up the lisinopril that was prescribed for blood pressure in the past. She did have the J&J covid vaccine 6 weeks ago.
68 2021-06-06 flushing Heart pounded heavily starting at 10PM preventing sleep. Continued until 3AM (April 29, when medics ... Read more
Heart pounded heavily starting at 10PM preventing sleep. Continued until 3AM (April 29, when medics arrived). Right side of face flushed. Front of thighs very flushed. Called 911. Medics measured blood pressure at 182/81. BP had always been normal (120/60 or less). Pulse = 84. BP lowered to c. 164/?? while medics were with patient. Patient saw her doctor a few days later. Metoprolol prescribed; started May 12 @25 mg with dosage increased to 100mg over three weeks. BLOOD PRESSURE REMAINS ELEVATED DESPITE MEDICATION 100mg daily. BP ranges erratically 184/81 to 134/66 on medication. BP HAS NOT RETURNED TO NORMAL.
68 2021-06-07 flushing FLUSHING ON SIDE FACE AND UPPER THIGH; POUNDING HEART; ELEVATED BLOOD PRESSURE; This spontaneous rep... Read more
FLUSHING ON SIDE FACE AND UPPER THIGH; POUNDING HEART; ELEVATED BLOOD PRESSURE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included generalized anxiety disorder (gad), high blood pressure, non-smoker, non-alcoholic, penicillin allergy, and erythromycin allergy, and other pre-existing medical conditions included the patient had no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 28-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: Blood pressure (NR: not provided) 120/60 mmHg. On 2021, Laboratory data included: Blood pressure (NR: not provided) 140/60 to 165/70 mmHg, 170/70 mmHg. Treatment medications included: metoprolol. On 28-APR-2021, the subject experienced flushing on side face and upper thigh. On 28-APR-2021, the subject experienced pounding heart. On 28-APR-2021, the subject experienced elevated blood pressure. On 29-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 182/81 mmHg, 160/60 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushing on side face and upper thigh, and pounding heart on 28-APR-2021, and had not recovered from elevated blood pressure. This report was non-serious.
68 2021-06-14 pain in extremity Had immediate severe pain in arm, head rush, hives, dizzy, sick to my stomach. Sick all week and mi... Read more
Had immediate severe pain in arm, head rush, hives, dizzy, sick to my stomach. Sick all week and missed 3 days of work.
68 2021-06-17 numbness, pain in extremity, tingling TROUBLE WITH HER VISION ON HER RIGHT SIDE; NUMBNESS IN RIGHT ARM AND LEG; TINGLING IN RIGHT ARM AND ... Read more
TROUBLE WITH HER VISION ON HER RIGHT SIDE; NUMBNESS IN RIGHT ARM AND LEG; TINGLING IN RIGHT ARM AND LEG; PRESSURE ON RIGHT SIDE OF HEAD; HEADACHE; PAINFUL ARM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and pain very rarely in her left leg.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced painful arm. On 30-MAY-2021, the subject experienced tingling in right arm and leg. On 30-MAY-2021, the subject experienced pressure on right side of head. On 30-MAY-2021, the subject experienced headache. On 31-MAY-2021, the subject experienced numbness in right arm and leg. On an unspecified date, the subject experienced trouble with her vision on her right side. Treatment medications (dates unspecified) included: acetylsalicylic acid, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble with her vision on her right side, and painful arm on 29-MAY-2021, was recovering from headache, and pressure on right side of head, and had not recovered from numbness in right arm and leg, and tingling in right arm and leg. This report was non-serious.
68 2021-06-17 nerve pain RED SPOTS UNDER SKIN ON CHEST AND ARMS; CHILLS; TOO TIRED; INJECTION SITE PAIN/ ARM AT INJECTION SIT... Read more
RED SPOTS UNDER SKIN ON CHEST AND ARMS; CHILLS; TOO TIRED; INJECTION SITE PAIN/ ARM AT INJECTION SITE HURTS; INJECTION SITE REDNESS; HEADACHE; FEVER; SHORTNESS OF BREATH; NERVE PAIN EVERYWHERE; PAIN IN LUNGS WHEN TALKING OR MOVING; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included fluticasone furoate for covid-19. On 10-JUN-2021, the subject experienced shortness of breath. On 10-JUN-2021, the subject experienced nerve pain everywhere. On 10-JUN-2021, the subject experienced pain in lungs when talking or moving. On 10-JUN-2021, the subject experienced chills. On 10-JUN-2021, the subject experienced too tired. On 10-JUN-2021, the subject experienced injection site pain/ arm at injection site hurts. On 10-JUN-2021, the subject experienced injection site redness. On 10-JUN-2021, the subject experienced headache. On 10-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.3 F. On 14-JUN-2021, the subject experienced red spots under skin on chest and arms. Treatment medications (dates unspecified) included: salbutamol sulfate, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 11-JUN-2021, was recovering from shortness of breath, and injection site redness, had not recovered from nerve pain everywhere, injection site pain/ arm at injection site hurts, red spots under skin on chest and arms, and headache, and the outcome of pain in lungs when talking or moving and too tired was not reported. This report was non-serious.
68 2021-06-18 tremor, involuntary muscle movements WOKE UP IN THE MIDDLE OF THE NIGHT HURTING ALL OVER (BODY PAIN); MORE TOTAL BODY JERKING; SORE JAW (... Read more
WOKE UP IN THE MIDDLE OF THE NIGHT HURTING ALL OVER (BODY PAIN); MORE TOTAL BODY JERKING; SORE JAW (PAINFUL TO OPEN MOUTH); TREMOR; JOINT PAINS FROM ARTHRITIS WORSENED; HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and back surgery, and concurrent conditions included osteoarthritis of all major joints, and benign essential tremor.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 23A21A, expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. Concomitant medications included paracetamol for pain. On 11-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced woke up in the middle of the night hurting all over (body pain). On 12-JUN-2021, the subject experienced more total body jerking. On 12-JUN-2021, the subject experienced sore jaw (painful to open mouth). On 12-JUN-2021, the subject experienced tremor. On 12-JUN-2021, the subject experienced joint pains from arthritis worsened. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from woke up in the middle of the night hurting all over (body pain), sore jaw (painful to open mouth), headache, joint pains from arthritis worsened, more total body jerking, and tremor. This report was non-serious.
68 2021-07-01 pain in extremity LOWER HEART RATE; LITTLE HEADACHE; SORE ARM; POTENTIALLY HELPED SYMPTOMS OF POSTURAL ORTHOSTATIC TAC... Read more
LOWER HEART RATE; LITTLE HEADACHE; SORE ARM; POTENTIALLY HELPED SYMPTOMS OF POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME/LESS ADRENALINE RUSH/ LESS NEUROPATHY; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included postural orthostatic tachycardia syndrome, neuropathy, hepatitis c, and adrenaline rush, and other pre-existing medical conditions included patient wore a heart monitor and normally heart rate was in 150 - 160s when play ball. patient can not take certain medications because liver enzymes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a71a, and expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced potentially helped symptoms of postural orthostatic tachycardia syndrome/less adrenaline rush/ less neuropathy. Laboratory data included: Heart rate (NR: not provided) 10 beats lower per minute, 140s, 130s, Low 140s, 156. On 02-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced little headache. On 05-JUN-2021, the subject experienced lower heart rate. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 150s. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little headache, sore arm, lower heart rate and potentially helped symptoms of postural orthostatic tachycardia syndrome/less adrenaline rush/ less neuropathy was not reported. This report was non-serious.
68 2021-07-08 discomfort Since receiving the vaccination, I have lost work due to flu symptoms a few days a month. On 20 Jun... Read more
Since receiving the vaccination, I have lost work due to flu symptoms a few days a month. On 20 June I began a slught Shingles outbreak. I was prescribed Valcyclovere. On 2 July, I experienced what felt like a sinus infection accompanied by cough and fever. I was prescribed Amoxicillin and prednisone. The discomfort in my sinus area, accompanied by headache, runny nose and fatigue, has not gone away. I reported these symptoms on the wellness check-in and was contacted by phone. Unfortunately, I was unable to properly understand the message and phone number to return the call.
68 2021-07-11 weakness, pain in extremity (1) Swelling behind left knee- approximately 1 month after vaccine (2) Pain inside left thigh and l... Read more
(1) Swelling behind left knee- approximately 1 month after vaccine (2) Pain inside left thigh and leg area - recurring since taking vaccine, nothing done, just noted (3) Wake up with stiffness in left side of neck approximately 2 times per week- recurring approximately 1 month after taking vaccine (4) Developed a dry cough - present and recurring everyday, approximately 1 month after vaccine (5) Severe insomnia noted after taking vaccine - developed approximately 2 months following vaccine (5) Severe lack of energy and body tiredness
68 2021-07-15 tingling, muscle spasms The patient had her vaccine on 6/10 and then on 6/11 began to experience tingling throughout her leg... Read more
The patient had her vaccine on 6/10 and then on 6/11 began to experience tingling throughout her legs and feet. She also complained of swelling in the feet in the mornings and shuffling gait. She also noticed joint pain and cramping in the legs. She still has these symptoms at this time.
68 2021-07-18 tingling Before the shot I was fine. Once taken, a month later i began feelkng worse and needed to go the the... Read more
Before the shot I was fine. Once taken, a month later i began feelkng worse and needed to go the the hospital. Some of the symptoms are, Pins and needles feeling in face hands and feet, bloated stomach.
68 2021-07-25 pain in extremity (Noted Auto-Immune Disease) Pt. states after receiving the dose of J&J vaccine 05/11/2021, started t... Read more
(Noted Auto-Immune Disease) Pt. states after receiving the dose of J&J vaccine 05/11/2021, started to experiencing symptoms 05/16/2021 a pulling pain in the right thigh, broken blood vessels through the leg (right), uncomfortable sensations going from groin to feet (both), pain beneath the fingernails, abdominal bloating, and chronic UTIs. Nerve sensations running through the facial area and (pinching) back of the head.
69 2021-03-07 weakness, feeling cold, tremor About 6 1/2 hours after receiving the vaccine, I began to feel really cold and began to have uncontr... Read more
About 6 1/2 hours after receiving the vaccine, I began to feel really cold and began to have uncontrollable shivering and shaking for 4 hours straight. A heating pad helped but continued after removing it. I also had a slight stomach ache. The next day, I felt i had less energy than normal, lethargic.
69 2021-03-07 burning sensation, tingling, numbness Johnson and Johnson Janssen COVID-19 EUA vaccine At the time of the injection, the vaccine burned a... Read more
Johnson and Johnson Janssen COVID-19 EUA vaccine At the time of the injection, the vaccine burned as it entered my arm. (I have never felt that burning sensation with any other vaccination that I have had in the past. Twenty minutes after the vaccination, I became lightheaded and dizzy. I could walk but I was wobbly. At one hour after the vaccination, I felt a sharp stabbing pain in the left side of my tongue and then the left side and only the left side of my tongue began to go numb. Within a couple of minutes, I realized that my left jaw was going numb, too. The numbness slowly but surely began to move up the left side of my face all the way to the top of my head. I had a sharp but brief headache on the left side of my head that subsided quickly but the numbness remained. I went home and talked to two people on the phone for several hours because they wanted to be sure that I was OK. At two hours after the vaccination, my face was still numb but I could think and talk clearly, but I was clearing my throat and coughing a lot. At that point, I also realized that my whole left arm was a little numb and my fingers on my left hand were tingling. That numbness lasted about 20 minutes and then subsided. The facial numbness lasted for hours. I wasn't scared and I wasn't in pain but it was very strange. It felt a little bit like the after affects of dental anesthesia but it wasn't just in my mouth it was the whole left side of my face. I believe that this must have been an allergic reaction to one of the chemicals in the vaccine but I don't know which one. If you can tell me which chemical it might have been, I will avoid it in the future.
69 2021-03-09 weakness weakness, sweating, fever, dry heaves
69 2021-03-09 pain in extremity Janssen COVID-19 Vaccine EAU I had a terrible headache for 2 days, chills for 2 days but slight ch... Read more
Janssen COVID-19 Vaccine EAU I had a terrible headache for 2 days, chills for 2 days but slight chills for 3 days, terribly achy body, dizzy, nauseous, a little trouble focusing my eyes, diarrhea for 2 days the 3rd and 4th days, slightly sore arm.
69 2021-03-10 weakness Chills, sweating, tiredness, queasy stomach, low energy
69 2021-03-10 tremor, tingling 5 hours post injection severe chills and severe shaking, numbing at ends of fingers and toes. 11 ho... Read more
5 hours post injection severe chills and severe shaking, numbing at ends of fingers and toes. 11 hours post injection feverish . Fever resolved 24 hours post injection. Over the course of the following few days, head and body aches and constipation . It is currently 3.5 days post injection and most side effects have resolved
69 2021-03-11 pain in extremity, weakness The pharmacist jam the needle into my arm to the bone and my arm is still a little sore. I could fe... Read more
The pharmacist jam the needle into my arm to the bone and my arm is still a little sore. I could feel the fluid running down in my arm. Around 5 hours or so after the shot, I was in bed for 2 days with chills/aches/fever, head pounding, and heart racing. Also I did not have an appetite. I am just getting my strength back and willing to trust myself walking.
69 2021-03-13 feeling cold As soon as I got the vaccine I started with a cough 30 hours later developed a fever chills headach... Read more
As soon as I got the vaccine I started with a cough 30 hours later developed a fever chills headache and it one point to it we?re not too three days muscle aches severely cold and now I have so I said my mouth five days later violent diarrhea five days later still sores
69 2021-03-14 tremor 48 hours -- shaking chills without fever. Drank extra water. Rested. Could not be warm. Dissipa... Read more
48 hours -- shaking chills without fever. Drank extra water. Rested. Could not be warm. Dissipated after 48 hours. Headache -- initially. Tylenol. Did not last more than an hour or two.
69 2021-03-18 flushing Described flushing on her face, took her own blood sugars = 62, then ate, came up to 300. Described ... Read more
Described flushing on her face, took her own blood sugars = 62, then ate, came up to 300. Described eye swelling. Stayed for full 30 min after vaccine. All symptoms went away and counseled to f/u with PCP or go to ED if urgent symptoms returned.
69 2021-03-19 tremor, weakness Slight pain at injection site. Moderate headache. Severe chills with chattering teeth and body shaki... Read more
Slight pain at injection site. Moderate headache. Severe chills with chattering teeth and body shaking. Severe fatigue. Moderate muscle aches. Nausea. Racing, pounding heart. Rate measured at 100 bpm. Continued for approximately 12 hours. Overall weakness. Slight dizziness at height of symptoms.
69 2021-03-21 weakness 5 hours after vaccination, I was freezing, wracked with shivers. I shivered violently. It came in ... Read more
5 hours after vaccination, I was freezing, wracked with shivers. I shivered violently. It came in waves. I could not get warm, even with a heated blanket. It finally subsided a little after midnight and I could sleep, waking every hour. My body was very achy, and I felt exhausted. I was very nauseous too. The next day, Sunday, my body still ached and I felt weak, like recovering from the flu. Today, Monday, I feel fine. I did not call my doctor.
69 2021-03-22 weakness SHAKING CHILLS, FEVER, MALAISE, SEVERE HEADACHE, NAUSEA, LOSS OF APPETITE, WEAKNESS, FATIGUE SYMPTOM... Read more
SHAKING CHILLS, FEVER, MALAISE, SEVERE HEADACHE, NAUSEA, LOSS OF APPETITE, WEAKNESS, FATIGUE SYMPTOMS STARTED ABOUT 10 HOURS AFTER RECIEVING THE SHOT TREATED WITH TYLENOL AND COOL CLOTHES TO HEAD FLUIDS FEVER BROKE AT 10:30 PM ON 03/17/2021, APPROX 19 HOURS AFTER RECEIVING THE VACCINE. SYMPTOMS SLOWLY SUBSIDED. PERSISTENT MILD TO MOD HEADACHE LASTED FOR SEVERAL DAYS
69 2021-03-23 tremor Five hours after the covid vaccine shot, chills so bad my whole body was shaking, was running a tem... Read more
Five hours after the covid vaccine shot, chills so bad my whole body was shaking, was running a temp , headache, aches all over.. these went away by the next morning but I continued to be very tired. Day three I was still very tired and developed a cold sore on the left corner of my mouth and sores in my mouth. Also had a left swollen gland near jaw line. I just layed low and rested. by March 23 the cold sore and sores in my mouth went away..
69 2021-03-25 bell's palsy Injection site redness and swelling that occurred days after the vaccine. Bell palsy that developed ... Read more
Injection site redness and swelling that occurred days after the vaccine. Bell palsy that developed approximately 5 days after receiving the vaccine.
69 2021-03-29 burning sensation On March 23, four days after the vaccine injection, I developed a burning pain in my Left arm and te... Read more
On March 23, four days after the vaccine injection, I developed a burning pain in my Left arm and temperature of 100.2 . An area about 5 inches in diameter was dark red and hot to touch. This area was well below the injection site, approximately 6 inches below the injection site. My doctor advised a cold compress and Benadryl. The area remained hot, red and itchy for 5 days. Temperature elevation lasted 24 hours.
69 2021-03-31 tenderness On day 9 felt both sides of neck tender under ear by jaw line. Upon palpation both sides painful ... Read more
On day 9 felt both sides of neck tender under ear by jaw line. Upon palpation both sides painful however left side more. Paid no attention to it except on day 10 because pain still felt with left side more painful. No lump or bump felt just very sensitive and painful upon palpation. Left side more painful when palpated. It seems to be going away slowly. Did not put this on my daily report because I chalked this up to being maybe a cold or something coming on. After thinking about this symptom I realized it is slowly going away and as an R.N. contributed to it now as a side effect. Below I put "No" regarding recovery because the pain is still there however not as bad. It seems to be going away slowly. Hoping it will be gone in a few more days.
69 2021-04-01 tremor, involuntary muscle movements, seizure, weakness Six hours after the shot I began to shake. I was not cold and my temp was only 99 degrees. The shaki... Read more
Six hours after the shot I began to shake. I was not cold and my temp was only 99 degrees. The shaking turned into uncontrollable jerking of my shoulders, torso and thighs. The jerking lasted 3 hours. My family became concerned and said I looked like I was convulsing. We were making plans to go to the ER when it started to calm down. I had no control over my body. I finally stood up and my body felt like I was made of led. Headache, slight fever, and weakness persisted until 48 hours post shot.
69 2021-04-02 weakness, tremor Tremors, fever, body aches, headaches, nausea, lightheaded, dizzy and feeling weak
69 2021-04-02 coordination abnormal My teeth started to hurt before I even got home. This usually means a sinus headache is coming. The ... Read more
My teeth started to hurt before I even got home. This usually means a sinus headache is coming. The next day I had a sinus headache, chills, was very fatigued, and was achy. I had a knee replacement in December and that knee ached so much I could barely stand on it. The next day I was fine.
69 2021-04-07 pain in extremity pt says she has an achy left arm then started getting chills, body aches, and 98.5 fever. She took ... Read more
pt says she has an achy left arm then started getting chills, body aches, and 98.5 fever. She took Tylenol that helped with her symptoms. She woke up today w/ a headache that has now subsided. Pt no longer has any of these symptoms.
69 2021-04-08 weakness dizzy, nausea, weak, headache, sweating, shivering, fever. 2 days. Nausea still continuing.
69 2021-04-08 pain in extremity Janssen COVID-19 Vaccine EUA headache, fever, fatigue, soreness of arm - as of this date, April 9, ... Read more
Janssen COVID-19 Vaccine EUA headache, fever, fatigue, soreness of arm - as of this date, April 9, 2021; 9:30 am. I expect to recover, but reporting these side effects for your information
69 2021-04-09 feeling cold injection site bled but no band aid was offered. following day a large knot appeared in my arm at t... Read more
injection site bled but no band aid was offered. following day a large knot appeared in my arm at the injection site, approximately the size of a golf ball. other reaction was feeling cold and tired, but not until the day after the knot appeared in my arm
69 2021-04-09 tremor, feeling cold On the night of the 3/9 at 10PM I had shakes/tremors in both my hands for 24 hours. I was freezing,... Read more
On the night of the 3/9 at 10PM I had shakes/tremors in both my hands for 24 hours. I was freezing, terrible head aches, and nauseated till , could not get out of bed and was very tired. I could not move till sunday night; 6 days later i started feeling better. I called my pcp on the 16,and the 23 complaining that i had pain in my ccchest anad heart, She said that it was allergies. I called her on the 3/23 again telling her that i still had pain in my chest/heart, She told me that it was allergies and that it was a side affect of the shot.On March 26 a neighbor came over that was a nurse took my pulse and said that i had an irregular heart beat.Called pcps office spoke to Nurse told to come in on3/30. PCP checked my lungs/heart.said nothing wrong. I told her to take an EKG-showed PAC
69 2021-04-10 weakness, feeling cold headaches, body aching pretty much all over, high fever,chills,shivering,cold,nausea,, loss of appet... Read more
headaches, body aching pretty much all over, high fever,chills,shivering,cold,nausea,, loss of appetite,diarrhea,very week,disn?t care about anything, could barely move, uncontrollable loud with moaning fast heavy breathing all onset approzimately 7.75 hrs after the injection and sum lasted for very approximately five hours, some lasted very approximately 14.75 hours abd some lasted very approximately 18.75 hours
69 2021-04-10 burning sensation As soon as she injected the vaccine into my arm I immediately felt a burning sensation go down the i... Read more
As soon as she injected the vaccine into my arm I immediately felt a burning sensation go down the inside of my arm to my wrist. It lasted about 5 minutes. I felt fine the rest of the day. The next day I developed a burning sensation in my tongue, mouth throat and chest. Then weakness in my chest and dificulting breathing. It is Saturday April 10, 2021 and the symptoms still come and go. The burning sensations mostly at night. The chest weakness and breathing issues seem to be in the morning and when I exercise. These symptoms are not as bad as they were initially but still present. I am unable to get an answer when I ask if the burning down my are is normal when getting a vaccine. No one else that I have talked with has experienced this symptom. I emailed my doctor she suggested taking tylenol.
69 2021-04-10 flushing Slight light headed ness, but major flushing and the beginnings of hives. I got myself up and ate 2... Read more
Slight light headed ness, but major flushing and the beginnings of hives. I got myself up and ate 2 Benadryl. Made it home, fell asleep for 3 hours, seems okay now.
69 2021-04-10 migraine 14 days of body chills, migraine headache, extreme fatigue, and diarrhea sine vaccine. Severe body c... Read more
14 days of body chills, migraine headache, extreme fatigue, and diarrhea sine vaccine. Severe body chills 13 days after vaccine followed by mild fever.
69 2021-04-14 weakness Chills, fever, stomach upset, weakness, exhaustion, general pain, diarrea that lasted 3 days then b... Read more
Chills, fever, stomach upset, weakness, exhaustion, general pain, diarrea that lasted 3 days then began improving.
69 2021-04-14 pain in extremity, migraine I experienced two days later, nausea and fatigue and headaches in the frontal lobe and around and be... Read more
I experienced two days later, nausea and fatigue and headaches in the frontal lobe and around and behind the eyes. On day 3-4; racing pulse ad felt breathless. I also felt fatigued, with shooting pain to my right arm. This pain comes and goes. I also have brain fog. My leg pain comes and goes. I have migraine headaches with fatigue, cough, nausea and sputum. I went to an acupuncturist which has helped a lot and will be going tomorrow for another session.
69 2021-04-14 pain in extremity Developed pain in arm, up into shoulder, across to neck. Still hurts at shoulder
69 2021-04-17 tremor LETHARGIC; VOMITING; SHAKING; FEVER; DIARRHEA; CHILLS; HEADACHE; NAUSEA; This spontaneous report rec... Read more
LETHARGIC; VOMITING; SHAKING; FEVER; DIARRHEA; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 125 pounds, and height was 64 inches. The patient's concurrent conditions included sulfa allergy, gluten allergy, dairy allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not had drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2020, Laboratory data included: Glycosylated hemoglobin abnormal (NR: not provided) UNKNOWN. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced lethargic. On 06-MAR-2021, the subject experienced nausea. On 06-MAR-2021, the subject experienced vomiting. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced shaking. On 06-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, vomiting, chills, shaking, and diarrhea on 06-MAR-2021, and had not recovered from fever, headache, and lethargic. This report was non-serious.
69 2021-04-18 feeling hot Fever...low grade...99.3 highest Body aches...everywhere on my body. Very tired for several days. N... Read more
Fever...low grade...99.3 highest Body aches...everywhere on my body. Very tired for several days. Nauseated.....on and off for 10 days Feet very hot....purple bruised like appearance under big toes, both toes ached for 11 days...thumb nails also had purple under the nails Blood vessels all over my body were larger then normal
69 2021-04-20 weakness Night of vaccine, patient experienced weekness, dizziness, nausea/vomiting, felt "odd". prolonged sy... Read more
Night of vaccine, patient experienced weekness, dizziness, nausea/vomiting, felt "odd". prolonged symptoms, tinnitis, continues to get dizzy and fall. One fall resulted in hitting head leading to ER visit. continued vertigo to this day, new onset of headaches. has reported this to pcp.
69 2021-04-20 weakness BODY PAIN; SHOOTING PAIN; COLD; PERSPIRING; HEADACHE; SLEEPY; WEAK; This spontaneous report received... Read more
BODY PAIN; SHOOTING PAIN; COLD; PERSPIRING; HEADACHE; SLEEPY; WEAK; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included hodgkin lymphoma, and back surgery, and concurrent conditions included lung diseases, heart diseases, and arthritis, and other pre-existing medical conditions included patient had no spleen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced sleepy. On MAR-2021, the subject experienced weak. On 27-MAR-2021, the subject experienced body pain. On 27-MAR-2021, the subject experienced shooting pain. On 27-MAR-2021, the subject experienced cold. On 27-MAR-2021, the subject experienced perspiring. On 27-MAR-2021, the subject experienced headache. Treatment medications included: clonazepam, hydrocodone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, shooting pain, and headache on 2021, and the outcome of cold, perspiring, weak and sleepy was not reported. This report was non-serious.
69 2021-04-20 pain in extremity Severe pain in left arm (not at injection site) - on side near breast, also severe pain in neck and ... Read more
Severe pain in left arm (not at injection site) - on side near breast, also severe pain in neck and left shoulder, but more severe in my back (left side below shoulder). Pain was only in arm on 4/3, 4, 5 & 6. Then reoccurred in arm, neck, shoulder and back on 4/15/21. Been taking 600mg Ibuprofen 4/18, 19 & 20. Can't take anymore since it bothers my stomach.
69 2021-04-20 pain in extremity I was sent to table 6. A young woman there started to swab my shoulder / very top of my arm. I told... Read more
I was sent to table 6. A young woman there started to swab my shoulder / very top of my arm. I told her to stop- I could see my friend at the other end of the table getting an injection 3 inches below the shoulder. Told the woman not to give me the injection so high. She said it had to go into the muscle. Told her there was just skin and bones that high and no muscle. She said she knew what she was doing. And gave me the injection. My arm and shoulder hurt immediately. Really hurt. I should have talked to someone in charge about her. A nurse watching us for 15 min said that pain at that point was normal. It has been almost 6 weeks and the pain is so bad that it wakes me up. Pain pills, Tylenol, Advil do not work. Please help me find a way to get rid of this pain. I did take a photo of the injection site later that day as the pain was still there. Went to my doctor and she said to give it more time. That was 2 weeks ago. This is a true story. I hope that you can help me get rid of the pain.
69 2021-04-21 pain in extremity 24 hours after vaccine patient had body aches, fever, chills which lasted 36 hours and then went awa... Read more
24 hours after vaccine patient had body aches, fever, chills which lasted 36 hours and then went away completely. Then on 3/18/21 patient developed bilateral hip pain, knee pain, ankle pain. Treated with prednisone 40 mg, taper by 10 mg every three days
69 2021-04-21 pain in extremity severe headache, fatigue, left arm pain and weakness, leg swelling
69 2021-04-21 pain in extremity SORE ARM; TIREDNESS; LYMPH NODE SWELLING OF LEFT BREAST; This spontaneous report received from a pat... Read more
SORE ARM; TIREDNESS; LYMPH NODE SWELLING OF LEFT BREAST; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced lymph node swelling of left breast. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lymph node swelling of left breast, and the outcome of tiredness and sore arm was not reported. This report was non-serious.
69 2021-04-21 pain in extremity DIZZINESS; ARM PAIN; CHILLS; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patien... Read more
DIZZINESS; ARM PAIN; CHILLS; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 99205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced arm pain. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, fever, and nausea, and was recovering from arm pain, and headache. This report was non-serious.
69 2021-04-22 numbness Consistent numbness in right side of face, left fingers, both legs, left arm. Symptoms started 2-3 ... Read more
Consistent numbness in right side of face, left fingers, both legs, left arm. Symptoms started 2-3 days after vaccination and symptoms have not subsided and continue to be of concern.
69 2021-04-22 muscle spasms pt says on the 6th day she woke up w/ a headache and nauseated. She started vomiting and took Mediz... Read more
pt says on the 6th day she woke up w/ a headache and nauseated. She started vomiting and took Medizine which seem to help. On 4/11/21 she started having cramps in her stomachs like a spasm and SOB. She went to hospital ER. They did blood work and Chest X-Ray which came back negative results. She was told she did not have the same blood disorder as the other people who have had blood clots after taking the vax. She was told she had blood in her urine but had no infection. She will FU w/ PCP in June. Pt says her only symptoms now are some nausea and still does not feel normal.
69 2021-04-22 tingling, numbness CONSTANTLY CLEARED THE THROAT; FELT KIND OF SWOLLEN THROAT; A LOT OF COUGHING; NUMBNESS IN LEFT ARM;... Read more
CONSTANTLY CLEARED THE THROAT; FELT KIND OF SWOLLEN THROAT; A LOT OF COUGHING; NUMBNESS IN LEFT ARM; TINGLING IN LEFT FINGERS; SHARP HEADACHE; TWINGE OF PAIN IN LEFT SIDE OF TONGUE; LIGHT HEADEDNESS; BURNING SENSATION AT ADMINISTRATION SITE/ TENDERNESS AT INJECTION SITE; LEFT-SIDED NUMBNESS THAT SPREAD FROM HER JAW, FACE TO TOP OF HEAD; LEFT SIDED FACIAL NUMBNESS LASTED FOR AT LEAST 5 HOURS DESCRIBED IT AS WAS SIMILAR TO DENTAL ANESTHESIA, BUT MORE EXTENSIVE; ALLERGIC REACTION; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, and concurrent conditions included seasonal allergy, vision damaged, and sensitivity to alcohol, and other pre-existing medical conditions included azithromycin allergy (headache, rash, hives, swollen lips, tongue and throat , breathing problems, chest pains, raises blood pressure), sulfadiazine allergy (headache, rash, hives, swollen lips, tongue and throat), omnicef allergy (headache, rash, hives, upset stomach), cefdinir, clonidine allergy (headache, rash, hives, upset stomach), cipro allergy (headache, rash, hives, upset stomach), aspirin allergy (upset stomach), cortisone allergy (feels like shards of glass), lisinopril allergy (cough), amlodipine allergy (swelling of legs &feet), hydrochlorothiazide allergy (headache, upset stomach). The patient experienced drug allergy when treated with amlodipine, acetylsalicylic acid, azithromycin, cefdinir, ciprofloxacin, clonidine, cortisone, hydrochlorothiazide, lisinopril, cefotaxime sodium, and sulfadiazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 14:05 to left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2020, Laboratory data included: COVID-19 antibody test (NR: not provided) Positive (units unspecified). On 06-MAR-2021, the subject experienced left-sided numbness that spread from her jaw, face to top of head. On 06-MAR-2021, the subject experienced left sided facial numbness lasted for at least 5 hours described it as was similar to dental anesthesia, but more extensive. On 06-MAR-2021, the subject experienced allergic reaction. On 06-MAR-2021 14:25, the subject experienced light headedness. On 06-MAR-2021 14:25, the subject experienced burning sensation at administration site/ tenderness at injection site. On 06-MAR-2021 15:05, the subject experienced twinge of pain in left side of tongue. On 06-MAR-2021 15:15, the subject experienced sharp headache. On 06-MAR-2021 16:00, the subject experienced constantly cleared the throat. On 06-MAR-2021 16:00, the subject experienced felt kind of swollen throat. On 06-MAR-2021 16:00, the subject experienced and had a lot of coughing. On 06-MAR-2021 16:00, the subject experienced numbness in left arm. On 06-MAR-2021 16:00, the subject experienced tingling in left fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from constantly cleared the throat on MAR-2021, and and had a lot of coughing, numbness in left arm, burning sensation at administration site/ tenderness at injection site, and sharp headache on 06-MAR-2021, had not recovered from light headedness, left sided facial numbness lasted for at least 5 hours described it as was similar to dental anesthesia, but more extensive, left-sided numbness that spread from her jaw, face to top of head, tingling in left fingers, and twinge of pain in left side of tongue, and the outcome of felt kind of swollen throat and allergic reaction was not reported. This report was non-serious.
69 2021-04-23 weakness WEAK; EXTREME TIREDNESS; This spontaneous report received from a patient concerned a 69 year old fem... Read more
WEAK; EXTREME TIREDNESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight was 125 pounds, and height was 64 inches. The patient's concurrent conditions included high blood pressure, non alcohol user, smoking, penicillin allergy, and sleep disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on left arm on 14-MAR-2021 09:30 for prophylactic vaccination. Concomitant medications included trazodone for for sleep, furosemide, and potassium. On 15-MAR-2021, the subject experienced weak. On 15-MAR-2021, the subject experienced extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme tiredness, and weak. This report was non-serious.
69 2021-04-23 pain in extremity ARM SORE; FATIGUE; This spontaneous report received from a patient concerned a 69 year old female. T... Read more
ARM SORE; FATIGUE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included depression, and concurrent conditions included anxiety, and non-smoker, and other pre-existing medical conditions included no known drug allergies. The patient was previously treated with buspirone for anxiety, and clonazepam for anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fatigue. On 11-MAR-2021, the subject experienced arm sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm sore on 18-MAR-2021, and had not recovered from fatigue. This report was non-serious.
69 2021-04-24 numbness April 15- late morning. Numbness right arm and hand and left arm. Loss of feeling in arm and hand. D... Read more
April 15- late morning. Numbness right arm and hand and left arm. Loss of feeling in arm and hand. Difficult to raise arms, heaviness. Lasted less than 30 minutes. April 16- late morning. Left leg/foot very heavy, couldn?t walk. Lasted less than 15 minutes. 4:00 pm. Numbness again in left leg. Lasted less than 15 minutes. 5:00pm. Numbness in left arm and thumb and first finger. Lasted less than 15 minutes.
69 2021-04-26 weakness Developed intense tinnitus on April 6th, partially debilitating accompanied with headaches, difficul... Read more
Developed intense tinnitus on April 6th, partially debilitating accompanied with headaches, difficulty sleeping, aches in ear and occasional shooting pain. On April 7th I had a NEGATIVE Covid test to rule out the disease. Ear Nose and Throat exam ruled out causes other than vaccine induced ototoxic impact to the ear nerve. audiology exam for hearing loss scheduled. It is now a month with no improvement and no proven treatment available.
69 2021-04-26 difficulty speaking FOGGY FEELING IN HEAD; BURNING IN THE HEART MUSCLE; EVERY BONE WAS HURT; HEADACHE; CHILLS; FEVER; SW... Read more
FOGGY FEELING IN HEAD; BURNING IN THE HEART MUSCLE; EVERY BONE WAS HURT; HEADACHE; CHILLS; FEVER; SWOLLEN HEART MUSCLE; CHEST PAIN; URINE COLORING YELLOW ORANGE; BODY ACHE; VOICE WAS HOARSE; This spontaneous report received from a patient concerned a 69 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced voice was hoarse. On APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced swollen heart muscle. On 07-APR-2021, the subject experienced chest pain. On 07-APR-2021, the subject experienced urine coloring yellow orange. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced foggy feeling in head. On 08-APR-2021, the subject experienced burning in the heart muscle. On 08-APR-2021, the subject experienced every bone was hurt. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, foggy feeling in head, voice was hoarse, fever, chills, and headache on 11-APR-2021, burning in the heart muscle, and every bone was hurt on 09-APR-2021, urine coloring yellow orange on 10-APR-2021, and body ache on APR-2021, and was recovering from swollen heart muscle. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
69 2021-04-29 discomfort, electric shock sensation 10 min. post inject Lt upper arm started swelling. No pain. 5min. later intense pressure/pain/surge ... Read more
10 min. post inject Lt upper arm started swelling. No pain. 5min. later intense pressure/pain/surge to nose & sinus's. Couldn't breathe thru nose. Within 15 sec sinus/nose rush went to entire head with dizziness & passing out intensity. Did not loose consciousness. RN on scene. 10min later made comeback. Beads of sweet on forehead. Lt. upper arm swelling gone. Felt fine for 3 days. On 3rd day rt & lt knees to ankles began off & on sporadic (static electricity like) shocks concentrated to one area at a time. Coming & going in daytime, not at night. Continuing for 10 days. On 9th shocks lessening but then started experiencing pressure in lt. leg calf. Went to ER & had lt leg doppler. Neg. for clots. Now 4wks. later shocks gone but pressure in rt. & lt. calves continue off & on.
69 2021-04-29 pain in extremity patient vaccinated at another location. approx 7 days post vaccination was admitted to the hospital... Read more
patient vaccinated at another location. approx 7 days post vaccination was admitted to the hospital for increasing shortness of breath and leg pain and swelling.
69 2021-05-02 mild one side paralysis The patient got her single shot Johnson and Johnson vaccine on 3/6/2021. Then, on or about 4/22/2021... Read more
The patient got her single shot Johnson and Johnson vaccine on 3/6/2021. Then, on or about 4/22/2021, she began to complaint of dizziness and left-sided weakness. She presented to emergency room on 4/29/2021 and was found to have a stroke via CT and MRI.
69 2021-05-02 unresponsive to stimuli, weakness HAD LITTLE WEAKNESS AND TIREDNESS SINCE NEXT DAY AFTER TAKING VACCINE ON 4/7/2021 ON 4TH DAY, MORNIN... Read more
HAD LITTLE WEAKNESS AND TIREDNESS SINCE NEXT DAY AFTER TAKING VACCINE ON 4/7/2021 ON 4TH DAY, MORNING, 8.00 AM, 4/11/2021, WHEN I CHECKED AFTER WAKING UP, PATIENT WAS NOTICED NOT RESPONDING, NOT BREATHING, NO HEART BEAT. 911 WAS CALLED AND ARRIVED AT 8.20 AM. THEY TRIED VARIOUS MEASURES FOR 1 HOUR, AND THEN THEY CONCLUDED THAT THE PATIENT IS NO MORE.
69 2021-05-03 weakness passed out in car. felt weak and fell over (according to spouse) syncope. Evaluated by EMS- Transpor... Read more
passed out in car. felt weak and fell over (according to spouse) syncope. Evaluated by EMS- Transported to Emergency room/department or urgent care.
69 2021-05-08 tremor, discomfort The injection site felt "achey" immediately after the injection and this discomfort lasted several h... Read more
The injection site felt "achey" immediately after the injection and this discomfort lasted several hours despite my gently massaging the band-aid site. My left arm felt "heavy" for the rest of the day. Within 18 hours of vaccination, I was awaken from sleep shaking violently. I thought that someone was shaking me violently. When I realized that my body was shaking so, I wrapped myself in a comforter; then I passed out or went back to sleep. When I was aware of myself again, I was too hot wrapped in the comforter and removed it. I was very concerned about what had happened to me so I moved slowly getting up and starting my day. I live alone so there was no one to help or advise me. For the next few days, I rested often, not sleeping, just feeling the need to lay about. By week 2 after the injection, I was "dragging" but not sleeping. When I laid down, my mind roamed about, when I tried to read or engage in meaningful activities were not successful. By week 3, I have full-blown insomnia. I go to bed at 4 am to be awake for hours while in bed, then being exhausted during the day. I am normally active, but I do not have the stamina to do what I love such as mowing my own lawn and working in garden. My heart rate jumps to 122 after 10-20 minutes of activities when in the past I could work steadily for 40 minutes and my heart rate never get above 90 beat per minute ( I wear a charge 2 watch that monitors exercise parameters.) I had to stop to rest up to 4 times to complete the yard work that I could normally complete in less than 40 minutes. Currently, I have "hay fever" symptoms: itchy runny nose, tickle in the throat with dry cough, tired, runny eyes and frontal headache; I take benadryl and other allergy medicines. I have poor sleep habits.
69 2021-05-09 pain in extremity TIGHTNESS IN HAMSTRINGS; BUTT PAIN; PAIN IN THIGHS AND CALVES AND ARM; GREAT DIFFICULTY IN MOVING; T... Read more
TIGHTNESS IN HAMSTRINGS; BUTT PAIN; PAIN IN THIGHS AND CALVES AND ARM; GREAT DIFFICULTY IN MOVING; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included polio, and concurrent conditions included arthritis in the arms, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with abaloparatide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced great difficulty in moving. On 15-MAR-2021, the subject experienced tightness in hamstrings. On 15-MAR-2021, the subject experienced butt pain. On 15-MAR-2021, the subject experienced pain in thighs and calves and arm. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) no blood clots, not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tightness in hamstrings, pain in thighs and calves and arm, and butt pain, and the outcome of great difficulty in moving was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509287.
69 2021-05-10 speech disorder, facial paralysis Received the Johnson and Johnson vaccine, went to get haircut. Went home, watched TV, and went to be... Read more
Received the Johnson and Johnson vaccine, went to get haircut. Went home, watched TV, and went to bed. Got up to use the restroom and noticed face was droopy and speech was off. Stayed in bed through the night and roommate cam in the morning and took to hospital
69 2021-05-11 feeling cold After 17 minutes, patient started feeling really cold and shivering. She requested a blanket and soc... Read more
After 17 minutes, patient started feeling really cold and shivering. She requested a blanket and socks which we got for her. We also called EMS and they took her to the hospital for evaluation
69 2021-05-15 tenderness + Homan?s Sign Right upper LE localized tenderness Warm to touch No MCR part A until 7/1/21 so not... Read more
+ Homan?s Sign Right upper LE localized tenderness Warm to touch No MCR part A until 7/1/21 so not sought tx Taking ASA 325 mg qd Thigh high compression Leg elevated/ bedrest
69 2021-05-17 pain in extremity ROLLING ACHE IN CHEST; FEELS LIKE FLU; STIFFNESS OF NECK; JAW GETTING READY LOCK AND FEELS OUT OF AL... Read more
ROLLING ACHE IN CHEST; FEELS LIKE FLU; STIFFNESS OF NECK; JAW GETTING READY LOCK AND FEELS OUT OF ALIGNMENT; LOW BLOOD PRESSURE/LOWER THAN NORMAL BLOOD PRESSURE; ACHINESS IN FINGERS FOR LONG TIME; ACHINESS IN SHOULDER ANKLE AND KNEE FOR LONG TIME; NECK PAIN; GLANDS SWOLLEN; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included temporomandibular disorder, and irritable bowel syndrome, and concurrent conditions included sulfonamide allergy, non alcoholic, non smoker, and controlled high blood pressure. The patient was previously treated with for drug used for unknown indication; and experienced drug allergy when treated with chlorpromazine for drug used for unknown indication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced glands swollen. On 30-APR-2021, the subject experienced neck pain. On 01-MAY-2021, the subject experienced achiness in fingers for long time. On 01-MAY-2021, the subject experienced achiness in shoulder ankle and knee for long time. On 02-MAY-2021, the subject experienced low blood pressure/lower than normal blood pressure. Laboratory data included: Blood pressure (NR: not provided) 112/65, 126/71, 124/84, 120/82, 138/72. On 06-MAY-2021, the subject experienced jaw getting ready lock and feels out of alignment. On an unspecified date, the subject experienced rolling ache in chest, feels like flu, and stiffness of neck. The action taken with covid-19 vaccine was not applicable. The patient was recovering from glands swollen, and neck pain, had not recovered from jaw getting ready lock and feels out of alignment, achiness in fingers for long time, and achiness in shoulder ankle and knee for long time, and the outcome of low blood pressure/lower than normal blood pressure, feels like flu, stiffness of neck and rolling ache in chest was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
69 2021-05-19 bell's palsy, weakness First adverse reaction was a headache behind right ear. This was a throbbing pain. Had low energy a... Read more
First adverse reaction was a headache behind right ear. This was a throbbing pain. Had low energy and a feeling of unwell. On 5/10/2021 had bad headache behind right ear. On 5/12/2021 I began swelling on the right side of my face with numbness on my right side lip area. On 5/13/2021 my face was fully distorted. On 5/13/2021 my neurologist diagnosed me with Bell's Palsy (G51.0). Neurologist ordered me on Prednisone 20mg three times per day for one week and initiate Physical Therapy. Ordered a blood test for Lyme disease.
69 2021-05-19 pain in extremity According to hospitalization discharge summary paperwork, patient presented to Hospital with bilater... Read more
According to hospitalization discharge summary paperwork, patient presented to Hospital with bilateral leg swelling and calf pain shortly after receiving the Johnson and Johnson Covid-19 vaccine.
69 2021-05-24 pain in extremity, nerve pain Headache on my left side for a few weeks, Left arm still aches, sharp nerve issue
69 2021-05-24 pain in extremity Intense UTI and urgency to urinate, no control of it. Fatigue/sleeping, brain confusion, aches, head... Read more
Intense UTI and urgency to urinate, no control of it. Fatigue/sleeping, brain confusion, aches, headaches everyday, old injuries became active again i.e. my broken hand 7 years ago began hurting and couldn't use it, my knee would not hold me up to stand and kept going out on me (from 2010 broken tibia and torn knee ligaments). Began a sinus infection, cough and eye pain with awful bouts of constant sneezing. Third round of antibiotics for the UTI and my bladder is still not right with leakage and urgency. Liver enzymes are high chart.
69 2021-05-24 pain in extremity On the day of the vaccine, participant just had a minor sore arm. A week and 2 days later, particip... Read more
On the day of the vaccine, participant just had a minor sore arm. A week and 2 days later, participant woke up with hives. The hives were located on both arms from shoulder to wrist and around the waist line. Participant went to Urgent Care. Participant was prescribed a shot of Prednisone, Prednisone 5mg 6 day Pak, OTC Benadryl twice a day, OTC Claritin twice a day and OTC Pepcid. If not improved, she was to come back in 3 days. Participant went back to the doctor in 3 day since her rash has not improved. Participant got another shot of Prednisone and told to D/C Prednisone 6 day and D/C Claritin and D/C Benadryl. Participant was prescribed Prednisone 12 Day Pak, Zyrtec, hydroxyzine 5mg 2 tablets 4 times a day, Singulair 10mg once a bedtime. Participant noticed her rash was improving with the new drug regimen and started clear up. After 2-3 days after finishing the medications, she started to break out again. Participant contacted her PCP via MyChart who referred her to an allergist specialist. She is awaiting an appointment with the allergist. Her rash is sporadic and will come and go andshe is currently taking Singulair, Zyrtec and Benadryl for the rash.
69 2021-05-27 pain in extremity, pain in extremity Intense UTI and urgency to urinate, no control of it. Fatigue/sleeping, brain confusion, aches, head... Read more
Intense UTI and urgency to urinate, no control of it. Fatigue/sleeping, brain confusion, aches, headaches everyday, old injuries became active again i.e. my broken hand 7 years ago began hurting and couldn't use it, my knee would not hold me up to stand and kept going out on me (from 2010 broken tibia and torn knee ligaments). Began a sinus infection, cough and eye pain with awful bouts of constant sneezing. Third round of antibiotics for the UTI and my bladder is still not right with leakage and urgency. Liver enzymes are high chart.
69 2021-06-06 mild one side paralysis Onset was 10 days after vaccination with a pressure-like headache and dizziness associated with cons... Read more
Onset was 10 days after vaccination with a pressure-like headache and dizziness associated with constant loud tinnitus bilaterally. She noted these symptoms for over 5 weeks, plus some right ear ache with occasional throbbing, amplification of some sounds, and some shooting pains in the head, plus insomnia. Symptoms seemed to subside on about 5/21, perhaps helped by her avoidance of caffeine and alcohol. There was a brief flare up the week of 5/19 after a meal of spicy food. That same week she notice some shuffling of the left foot and apparent left leg weakness, without injury.
69 2021-06-14 weakness Early a.m. 2nd day had bad headache. By 6 a.m., very tired with light occasional chills; headache co... Read more
Early a.m. 2nd day had bad headache. By 6 a.m., very tired with light occasional chills; headache continued - took 1 ibuprofen Day 3 very lethargic; no energy at all Day 4 bad lower intestinal pains with eventual diarreah; extremely tired
69 2021-06-16 tingling, cold extremities, numbness, muscle spasms Cramping began in right leg off & on over 6wk period. Not thinking much of it just older I guessed. ... Read more
Cramping began in right leg off & on over 6wk period. Not thinking much of it just older I guessed. Then on June 6th my calf locked up & could barely walk. Later in evening my toes & foot went numb & cold & no feeling. Called Ambulance to take me to Hospital. 6 days of treatment. Many injections & needles.
69 2021-06-21 pain in extremity 2 different events: 1) 20-30 minutes after the shot, I felt dizzy and disoriented, similar to car-si... Read more
2 different events: 1) 20-30 minutes after the shot, I felt dizzy and disoriented, similar to car-sickness, but I wasn't in a moving vehicle; It appeared that the center of the field of vision for my left eye had become blurred. Subsequently, I had a bad headache and body aches, which lasted most of that day and the next day. My vision is still blurred. A visit to my optician on 13 April 2021 confirmed an epi-retinal membrane, which was not present at my previous eye exam. 2) about two weeks after the shot, I experienced severe pain and raised blood vessels in different areas of both my fore arms, hands and fingers, and my lower left leg and left foot. These lasted a few minutes and then subsided. They were severe enough to wake me up multiple times every night. I finally went to my doctor's office on April 26, saw the nurse practitioner who actually watched one of these episodes. She consulted Dr., they were only concerned about my left leg being a potential blood clot; said the other areas were unlikely to cause significant problems, sent me for an ultrasound examination of my left leg on April 27th, which showed no blood clot. The intermittent raised veins and pain continued for another week or so then subsided.
69 2021-06-27 pain in extremity, weakness, brain damage, depressed level of consciousness 69 YO female received one dose of J&J vaccination on 3/12/21. 4/8: Patient complaint of epigastric ... Read more
69 YO female received one dose of J&J vaccination on 3/12/21. 4/8: Patient complaint of epigastric abdominal pain almost nightly since March 12 (coincided with her COVID vaccination) described as 10/10, crampy and without radiation. CT abdominal and pelvis with contrast showed infiltrating mass in the left hepatic lobe concerning for intrahepatic cholangiocarcinoma with reactive adenopathy. Additionally, left mid ovarian vein thrombus found. No thrombus in the renal veins or IVC. 4/28: Venous duplex demonstrated bilateral leg acute DVT. Eliquis was started. 5/7: Pt underwent laparoscopic biopsy/paracentesis. Eliquis was held 2 days prior to laparoscope...5/11: Pt presented to hospital with complaints of generalized weakness, fatigue and leg pain. CTPA showed bilateral PE. Pt received heparin drip and was switched back to Eliquis on discharge. Echocardiogram on 5/12 noted mobile round mass in RV junction, right atrial mass; presumed to be a thrombus. Pt additionally with elevated troponin, determined to likely demand ischemia related to PE; EKG without any acute changes. Discharged on 5/24. 5/27: Patient started on chemotherapy with gemcitabine/cisplatin for metastatic intrahepatic cholangiocarcinoma. 6/4: Presented to the ED again due to worsening dyspnea and home pulse ox readings in the 70s. CT chest showed moderate burden of bilateral obstructive pulmonary emboli with no overt RV strain. EKOS and clot retrieval was contraindicated d/t thrombocytopenia. Was noted to have demand ischemia, and transitioned from eliquis to heparin gtt. Vascular was consulted for eval of her ischemic right foot, and deemed that it needed amputation, but would be a high risk surgery. 6/8: Patient was transferred to this reporting institution for second opinion requested by the family. Upon arrival, patient was found to be obtunded and hypotensive requiring heated high flow nasal cannula and vasopressor with norepinephrine. Code status was deemed DNRCCA/Do not intubate per family. Bedside ultrasound was concerning for an LV mass. Cardiology and Vascular surgery were consulted and recommended that the foot be amputated as well, but requested further workup with ECHO and CTA chest/abdomen/pelvis to further evaluate the LV mass. During admission workup, she was incidentally found to be COVID PCR positive. She was started on DEXA-ARDS prednisone dosing, remdesivir, and placed in enhanced droplet isolation. Her hospital course was complicated by acute hypoxemic respiratory failure due to pulmonary emboli, COVID-19 infection, and underlying malignancy requiring heated high flow nasal cannula. Empiric cefepime was started to treat any underlying superimposed pneumonia. Due to extensive clot burden with limb ischemia, as well as + COVID, she was systemically anticoagulated with a heparin drip despite her thrombocytopenia. She was intermittently given platelet transfusions in order to keep platelet count >30. TTE was obtained on 6/11 which showed large masses in right ventricle and right atrium, vegetations on mitral valve, aortic valve, and tricuspid valve, and probable mass in IVC. She also developed AKI with oliguria related to shock and critical illness. Medical oncology was consulted and she unfortunately was not a candidate for further chemotherapy at the time due to critical illness, as well as ischemic limb. (If further treatment was pursued, she would need a left leg amputation, then would require 4-6 weeks of recovery before additional chemotherapy could be given.) She slowly became more encephalopathic and had increased oxygen requirements, requiring continuous heated high flow nasal cannula. Goals of care were discussed with her family. Given her advanced cancer, it was decided to transition to comfort-focused care. Her code status was changed to DNRCC. Symptoms were controlled with IV pain and anxiety medication. She expired on 6/13/2021 at 0225.
69 2021-06-29 muscle spasms I woke up thinking I had a bad cramp on left side, above the heart. Didn't go away! Called on call... Read more
I woke up thinking I had a bad cramp on left side, above the heart. Didn't go away! Called on call Dr, was told I had costochondritis. No reason could be found. Two weeks later, saw my Dr. Again, no reason found. Just happens is the basic thought. For me, I would like to add, when I received the shot, I felt I HAD TO BE IN RAPPORT with everyone...my husband made the appointment for the shot. I felt "out of choice, no self governance " over my body. I had wanted to wait, until I was ready, perhaps another week or two. Being in rapport hurts the connective tissue. I betrayed myself. I cannot blame the vaccine, only myself for not listening and waiting until I felt 100% capable of handling the vaccine within my body. 13 hours after I had the vaccine, I became ill. My bowels also have been slow to regain their true rhythm. Again I blame me for rejecting the vaccine!!!! I am only reporting this, because I believe a study about connective tissue and rapport, along with the willingness of someone to receive the vaccine would be interesting for someone to study. I ache, still, from the costochondritis. I take that ache as a reminder, and my responsibility to be more at peace with my choices. Thank you for listening, feels good to express myself.
69 2021-07-12 pain in extremity My arm muscle was soar after the shot and the muscle continues to be soar four months later. I hea... Read more
My arm muscle was soar after the shot and the muscle continues to be soar four months later. I heard a news story about this situation this morning thus I am reporting my experience now.
69 2021-07-21 tingling, numbness Numbness and tingling in the contralateral hand and foot (left side). Numbness now developing in the... Read more
Numbness and tingling in the contralateral hand and foot (left side). Numbness now developing in the hand on side of injection. Numbness in hands seems to be mimicking CTS.
70 2021-03-03 burning sensation couple of hours after receiving the injection, I had a large hive on my mid chest area. Later I had ... Read more
couple of hours after receiving the injection, I had a large hive on my mid chest area. Later I had one on my hip. I was not concerned as I have them on occasion. I felt fine. Went to bed that evening and woke up with extreme burning and itching in my index finger and thumb of my right hand. Also a very large hive on the inside of my arm about 2 1/2 inches from my wrist bend. Intense itching. I took a Benadryl tablet and felt better almost immediately. Later in the day about 6 1/2 hours later, I had more itching on my hip where the high was located. I took another Benadryl. I am fine. I also call my doctor and reported it.
70 2021-03-06 flushing, weakness I received the vaccine at a Department of Health vaccine clinic at the Hospital. About 25 minutes af... Read more
I received the vaccine at a Department of Health vaccine clinic at the Hospital. About 25 minutes after receiving the Janssen vaccine, my face became flushed (red) and I felt weak. We were in the hospital parking lot and drove to that hospital's emergency room, where I was evaluated. After several tests (item 18) I was declared okay and left after 3 hours with no further intervention. I probably should have taken a Benadryl (diphenhydramine) after the shot to prevent such a reaction.
70 2021-03-06 tremor, restless legs syndrome 7:30pm unusual restlessness in both legs; by 8:30pm dull constant pain increased, legs were weak, kn... Read more
7:30pm unusual restlessness in both legs; by 8:30pm dull constant pain increased, legs were weak, knees wobbly, hands shaking. Pain in legs became intense; I could not sit on the toilet. Went to emergency room of Hospital at 9pm; no medications given. Pain calmed by 10pm, but sensation in legs returned at 11pm and continued until discharge at 1:15am on 3/6. Took Tylenol PM at home for moderate pain in legs and went to bed. Awakened next morning to no pain, had breakfast and went back to bed until noon. Feeling fine since that time.
70 2021-03-07 weakness 11.5 hours after vaccine I began to vomit and continued for 48 hours with dry heaves. Only drank wat... Read more
11.5 hours after vaccine I began to vomit and continued for 48 hours with dry heaves. Only drank water then vomited . Ate 1/2 cut of chicken soup and vomited it up. Constant chills. Back ached so bad I couldn't sleep first 24 hours. Still feel week 3 days later, however able to eat and drink with no nausea 1200 noon on 03/08/21. No health issues, no medications.
70 2021-03-09 feeling cold Extreme chilling and body aches. Aching lasted about 24 hours.
70 2021-03-09 tremor High fever, headache, muscle pain, neck pain, dizziness, tremors starting with in 7 hours of injecti... Read more
High fever, headache, muscle pain, neck pain, dizziness, tremors starting with in 7 hours of injection lasting all night and next day
70 2021-03-10 feeling cold, feeling hot Began feeling tired on way home at 3 pm, rested in chair until 9 pm, in bed was so cold and shiveri... Read more
Began feeling tired on way home at 3 pm, rested in chair until 9 pm, in bed was so cold and shivering even with two heavy blankets. Headache developed, heart was pounding (97 pulse rate), headache was the worst ever. Could not sleep, then got up all night until 4 am , finally got back into bed, slept a little, then got extremely hot and sweaty. Finally slept until 9:45 am, still have headache but not as bad. Heart more normal, pulse 75. My temperature stayed a little below normal, 96.6 degrees.
70 2021-03-10 pain in extremity Ten hours after vaccination into my left arm, my right arm, right leg, and right hip bones felt as i... Read more
Ten hours after vaccination into my left arm, my right arm, right leg, and right hip bones felt as if they were being crushed. I finally fell asleep for an hour or two, then awaken just in time to make it to the bathroom where I sat on the toilet ALL night having severe diarrhea and vomiting into a container on my lap. I would fall asleep, then wake up, on the toilet, very sick. The vomiting ended after that first night, but the diarrhea has persisted. It is getting better, though. (It has been 72 hours since the shot.) I had a headache, my left arm ached, I was nauseous, and feverish until about 8 a.m., today, when my fever broke. I still feel like I have a low-grade flu, which I have not had in over 40 years. And, I still have some diarrhea. I am sipping Coke and can eat some Cheerios, with milk and banana, but that is all that I want to attempt.
70 2021-03-10 speech disorder Developed a lisp in speech that has continued since the evening of receiving vaccine.
70 2021-03-12 weakness, feeling cold Got extremely cold and shivering starting around 6:30 pm on Friday 3/12/21. Could not get warm. To... Read more
Got extremely cold and shivering starting around 6:30 pm on Friday 3/12/21. Could not get warm. Took my temperature and it was 97.1 (my temp is usually in the mid 97's). Weak and tired. Took Tylenol about 7:30 pm - it helped a little but still felt freezing cold. Went to bed and next morning felt better but wrung out.
70 2021-03-14 sciatica fever and chills, sciatica inflammation went away
70 2021-03-17 weakness Today I started to have a bad stomach ache and thought I was having indigestion. Thean I had loose ... Read more
Today I started to have a bad stomach ache and thought I was having indigestion. Thean I had loose bowels. This continued and got worse. This started around 11 a.m. Around 3 p.m. I felt dizzy and faint and nearly passed out. I was very weak. I had to lie down. I still feel weak and dizzy and it is now 4 pm but I feel a little better. My stomach is still gurgling
70 2021-03-19 muscle spasms, muscle twitching, tenderness Heart palpitations, rt leg muscle and foot cramping, left leg twitching, headache, tired, arm tender
70 2021-03-19 unresponsive to stimuli Patient lost consciousness and was unresponsive for few minutes. She came to and began to vomit. 9... Read more
Patient lost consciousness and was unresponsive for few minutes. She came to and began to vomit. 911 was called immediately and the area was secured with privacy screens. In the meantime, patient was moved to the ground to lie down on her side. She continued to feel nauseas and out of it. The EMTs arrived promptly and took over, once they arrived.
70 2021-03-23 weakness Fever of 102F, Derma, between 11:30 PM to 2:30 AM, Chills at same frame, Sore Throat, Headache, poun... Read more
Fever of 102F, Derma, between 11:30 PM to 2:30 AM, Chills at same frame, Sore Throat, Headache, pounding continuing from 11:30, 03/23/21 until 9:45 03/24/21, Several hours of weakness and dizziness, Injection site, Left arm, continues to be sore.
70 2021-03-23 tingling Starting at 11:30pm started feeling queezy; then got chilled. The chills turned into shivering & bod... Read more
Starting at 11:30pm started feeling queezy; then got chilled. The chills turned into shivering & body shaking & teeth chattering. Neck muscles & jaw muscles hurt. Dressed in polar fleece jammies, socks, flannel bed-sheets, two heavy duvets & couldn't get warm nor stop the shaking. Tried standing to walk it off but legs were like jelly. Tried bio-feedback to relax & stop the shivering but it just continued in wave after wave. My chest tingled and my heart felt like it was working hard. It subsided around 4:30a.m. The next day felt 'punk' muscles still jelly like & jaw really ached from chattering. The 2nd day was fine.
70 2021-03-27 numbness, tingling Second day was just a slight fever and fatigue, resolved on day 3rd day of symptoms. However, on th... Read more
Second day was just a slight fever and fatigue, resolved on day 3rd day of symptoms. However, on the 4th day, got numbness and tingling in both legs up to above the knees. I also had numbness and tingling in hands and arms. These symptoms resolved in about 2.5 weeks.
70 2021-03-31 pain in extremity pts left arm became very sore and she has a red hard painful knot. The arm is in alot of pain at ti... Read more
pts left arm became very sore and she has a red hard painful knot. The arm is in alot of pain at times and does not seem to be getting any better at this time and it has been more than two weeks. Pt will contact PCP.
70 2021-04-02 facial paralysis, bell's palsy Received Janssen vaccine 3/18/21 - on 4/1/21 (14 days later) woke up with numbness to left side of f... Read more
Received Janssen vaccine 3/18/21 - on 4/1/21 (14 days later) woke up with numbness to left side of face (can't close L eye, can't raise L eyebrow, left mouth crooked with smiling, watery left eye), and possibly droopy R eye. No diplopia, no weakness limbs (gait ok), no pain - went urgent care - transported to ER due to concerns of TIA/CVA
70 2021-04-04 tremor About 10 hours after receiving vaccine, I suddenly began shaking, so hard I could barely walk. At ... Read more
About 10 hours after receiving vaccine, I suddenly began shaking, so hard I could barely walk. At the same time, my fever shot up to 101.8, and mucus began running from my nose like never before. Shaking subsided after an hour or so, fever broke during the night, and cold symptoms lasted about 3 days.
70 2021-04-06 pain in extremity SINUS SYMPTOMS; DRYNESS; SORE ARM; This spontaneous report received from a patient concerned a 70 ye... Read more
SINUS SYMPTOMS; DRYNESS; SORE ARM; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced sore arm. On 29-MAR-2021, the subject experienced sinus symptoms. On 29-MAR-2021, the subject experienced dryness. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm on 30-MAR-2021, and was recovering from sinus symptoms, and dryness. This report was non-serious.
70 2021-04-08 burning sensation Intense itching and burning and breakout on neck, right side of face, and nose after 12:30 am Thursd... Read more
Intense itching and burning and breakout on neck, right side of face, and nose after 12:30 am Thursday am. By Thursday afternoon, eruptions began on chest from shoulder to shoulder. Pain still persists where the rash presented. Diagnosis-Shingles
70 2021-04-08 facial pain Severe muscle pain throughout body, legs and arms weak to the point of not being able to walk or get... Read more
Severe muscle pain throughout body, legs and arms weak to the point of not being able to walk or get to the bathroom, chest pain, severe head/face pain, dizziness/vertigo, chills, fever, vomiting. Was so bad that I thought about calling 911. 15 hours later - muscle pain remains, head exploding pain, dizzy.
70 2021-04-09 pain in extremity BUMP UNDER THE SKIN (KNOT AROUND 1/4 INCH BIG AND A LUMP); RED PATCH (RED SPOT); SWELLING; SORE ARM;... Read more
BUMP UNDER THE SKIN (KNOT AROUND 1/4 INCH BIG AND A LUMP); RED PATCH (RED SPOT); SWELLING; SORE ARM; This spontaneous report received from a consumer concerned a 70 year old female. The patient's weight was 200 pounds, and height was 63 inches. The patient's concurrent conditions included high blood pressure, type 2 diabetes mellitus, high cholesterol, skin cancer, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 10:00 to right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced sore arm. On 03-APR-2021, the subject experienced bump under the skin (knot around 1/4 inch big and a lump). On 03-APR-2021, the subject experienced red patch (red spot). On 03-APR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on APR-2021, and swelling on 04-APR-2021, and had not recovered from bump under the skin (knot around 1/4 inch big and a lump), and red patch (red spot). This report was non-serious.
70 2021-04-09 pain in extremity This spontaneous report received from a patient concerned a 70 year old female. The patient's weight... Read more
This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 30-MAR-2021, the subject experienced body aches. On 30-MAR-2021, the subject experienced chills. On 30-MAR-2021, the subject experienced soreness while lifting arm. On 30-MAR-2021, the subject experienced minor nausea. On 30-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness while lifting arm on APR-2021, and was recovering from minor nausea, chills, and fever, body aches. This report was non-serious. This case, from the same reporter is linked to 20210410251.
70 2021-04-11 flushing Patient showed up to clinic with Dr's note saying she has allergies but that she should get the COVI... Read more
Patient showed up to clinic with Dr's note saying she has allergies but that she should get the COVID 19 Vaccine. Prior to administration, patient appeared anxious and states "I shouldn't have had mayo...I'm allergic to eggs." appx 5 min later, patient appears flushed and c/o chest tightness. Was moved into room to lay down and Dr was brought in along with a total of 3 RNs, 1 EMT-1, etc. MD prescribed 50mg Benadryl IM and patient was sent to hospital via local ambulance. During event, patients BP was elevated, HR 120s, SPO2 96% on 1L O2. Patient was able to speak in full sentences and lung sounds were clear bilaterally.
70 2021-04-12 feeling cold Patient described kidney pain for a few hours and she was freezing and her teeth were chattering for... Read more
Patient described kidney pain for a few hours and she was freezing and her teeth were chattering for 2 hours. She stated that adverse effects resolved and she stated she has an upcoming appointment with her nephrologist.
70 2021-04-12 tingling 3 days after shot - tingling in left hand and left foot - CIDP symptoms or maybe a pinched nerve
70 2021-04-12 paralysis Patient states that on the night of 4/9/2021 around 10PM she was laying down and felt paralyzed and ... Read more
Patient states that on the night of 4/9/2021 around 10PM she was laying down and felt paralyzed and could not move for 6 hours. Patient states that she was unable to call 911 because she could not move.
70 2021-04-12 restless legs syndrome She got the vaccine, and where she got the shot it turned red, about the size of two silver dollars,... Read more
She got the vaccine, and where she got the shot it turned red, about the size of two silver dollars, very sore. Right above that a very big red spot popped up. She had itching and bumps on her feet and then over her whole body. she had red spots and a rash on her stomach, and a big rash on her back and all over her face. She had diarrhea, headache, flu symptoms with aches all over her body. The aches went away except in her feet and her toes, it hurt to walk due to the toe pain. She still has the bumps and the itching, but took the Benadryl, but cannot take that as it gives her restless leg syndrome, and is now takin Claritin. She now has itching in her lips, has allergies in her eyes, She has not call her doctor. She talked to the person who gave her the shot and also Wal-Mart pharmacist who told her to take the Claritin. These symptoms have continued.
70 2021-04-13 weakness The evening of shot had low grade temp, temperature continued into second day. Second day at night ... Read more
The evening of shot had low grade temp, temperature continued into second day. Second day at night temp went up to 102.8. Third day temp went down to low grade, fourth day temp returned to normal. Drank plenty of fluids and took Tylenol to lower temperature. Did experience flu like symptoms - body ache, and weakness.
70 2021-04-13 burning sensation About an hour after vaccine my eyes started hurting....got worse....felt like they were on fire; eye... Read more
About an hour after vaccine my eyes started hurting....got worse....felt like they were on fire; eyes were swollen and bloodshot within 1-1/2 hrs of vaccine; vision blurry. I applied cool/cold compresses rest of day and throughout night; took Tylenol . By next morning eyes were better but still a little bloodshot. And also had an ache behind the eyeball area. Took more Tylenol and eyes continue to improve that day.
70 2021-04-13 feeling cold, numbness Head ache, ringing in the ears, Arthritis in the hands, Numbness in right finger, stiffness in body,... Read more
Head ache, ringing in the ears, Arthritis in the hands, Numbness in right finger, stiffness in body, feeling cold and feeling agitated.
70 2021-04-13 muscle spasms Patient experienced some extreme "charlie horse" cramps in her legs occasionally in the weeks follow... Read more
Patient experienced some extreme "charlie horse" cramps in her legs occasionally in the weeks following vaccination. She did not report them to the pharmacy until 4/13/21 when she saw the news regarding the blood clot adverse events and thought it may be relevant. She had charlie horses in the past but had not had them in recent history until after her vaccine. It happened 3 times, all in the middle of the night, mostly in her right leg. She did not need to see medical attention for any of them.
70 2021-04-13 pain in extremity deep vein thrombosis, swelling, pain in both legs and lower abdomen. warm and red skin. red swolle... Read more
deep vein thrombosis, swelling, pain in both legs and lower abdomen. warm and red skin. red swollen veins.
70 2021-04-13 cold extremities J&J vaccine 3/15 and on 4/2/2021 I thought I pulled a muscle and my leg started swelling, but my rig... Read more
J&J vaccine 3/15 and on 4/2/2021 I thought I pulled a muscle and my leg started swelling, but my right leg only. I thought it would go down and my leg and foot started swelling up and my foot got really cold. I went to the hospital on 4/11 and they said it was a DVT and they checked my lungs and said I had small blood clots in my lungs as well. They put me on Eliquis to keep my blood thinned out.
70 2021-04-14 pain in extremity bilateral calf pain as well as behind both arms, pitting edema of bilateral ankes
70 2021-04-14 pain in extremity Pt had Johnsons and Johnsons vaccine Pt presented to the ER with shortness of breath and left leg p... Read more
Pt had Johnsons and Johnsons vaccine Pt presented to the ER with shortness of breath and left leg pain. She had a CT and ultrasound that showed a PE.
70 2021-04-15 weakness On 3/31/2021 Patient developed blurred vision and excruciating headaches with extreme weakness. Pt ... Read more
On 3/31/2021 Patient developed blurred vision and excruciating headaches with extreme weakness. Pt went to an urgent care where they found bleeding in brain so they sent her via ambulance to ER at another hospital. She had MRI, CT and blood work. She was admitted into the ICU where she was treated for 3 days and then transferred to telemetry. Pt was discharged to FU w/ Neurologist and Ophthalmologist.
70 2021-04-15 weakness WEAKNESS; FATIGUE; LOSS OF APPETITE; NAUSEA; This spontaneous report received from a patient concern... Read more
WEAKNESS; FATIGUE; LOSS OF APPETITE; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included Covid-19 infection, and concurrent conditions included floxacin allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not had history of any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced loss of appetite. On 07-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced weakness. On 08-APR-2021, the subject experienced fatigue. On JAN-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, and nausea on 09-APR-2021, and had not recovered from fatigue, and weakness. This report was non-serious.
70 2021-04-15 cold sweat 04/04/2021 - Significant shortness of breath when I went for outdoor walk around lake; 04/09/2021 - ... Read more
04/04/2021 - Significant shortness of breath when I went for outdoor walk around lake; 04/09/2021 - Awoke in cold sweat with blinding headache - checked in with work saying I was out for day at 04:12 am, took Aleve, and slept for the rest of the day. Slept for most of weekend
70 2021-04-15 pain in extremity METALLIC TASTE; SORE ARM; PAIN IN SHOULDER; HEADACHE; This spontaneous report received from a patien... Read more
METALLIC TASTE; SORE ARM; PAIN IN SHOULDER; HEADACHE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breathing issues, milk allergy, sulfa drug allergy, and hoarseness of voice, and other pre-existing medical conditions included the patient is not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: clarithromycin ( batch number: UNKNOWN expiry: UNKNOWN, form of admin, route of admin, and were not reported) 500 mg, 2 times every 1 day, therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced metallic taste. On 11-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced pain in shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from metallic taste, sore arm, headache, and pain in shoulder. This report was non-serious.
70 2021-04-15 pain in extremity vaccine 3/7/21. 4/9/21 presented in ER with leg pain. dx with dvt. has no prior hx or fam hx of ... Read more
vaccine 3/7/21. 4/9/21 presented in ER with leg pain. dx with dvt. has no prior hx or fam hx of clots. is not a smoker. is on hrt. treating dvt with eliquis.
70 2021-04-17 feeling hot, tingling 4/14/2021 woke up with leg tingling and warm sensation and tightness .in right calf not painful but... Read more
4/14/2021 woke up with leg tingling and warm sensation and tightness .in right calf not painful but annoying next day both legs from knees down friday called pcp didnt think it was anything to worry about just keeps an eye on it watch for swelling and redness saturday it was much better. Sometimes it happen in my left arm. today brothering me again
70 2021-04-17 pain in extremity Sore arm headache,left arm couldn't lift ,chest pains,Nausea
70 2021-04-18 weakness Shortness of breath nausea weakness ***note patient tested negative to Covid but was exposed***
70 2021-04-18 weakness Severe nausea; Vomiting; Diarrhea; Headache; Low energy; This spontaneous report received from a pat... Read more
Severe nausea; Vomiting; Diarrhea; Headache; Low energy; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced low energy. On 10-MAR-2021, the subject experienced severe nausea. On 10-MAR-2021, the subject experienced vomiting. On 10-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low energy, severe nausea, vomiting, and diarrhea on MAR-2021, and had not recovered from headache. This report was non-serious.
70 2021-04-19 weakness, pain in extremity, tingling OPTIC NERVE DAMAGE; DIARRHEA; BRUISED ARM; TINGLY FACE; STOMACH CRAMPS; SHIVERING/CHILLS/FELT COLD; ... Read more
OPTIC NERVE DAMAGE; DIARRHEA; BRUISED ARM; TINGLY FACE; STOMACH CRAMPS; SHIVERING/CHILLS/FELT COLD; SORE ARM; WEAKNESS; NAUSEOUS RIGHT ON THE SPOT.; TIREDNESS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included minor low pressure glaucoma, blood pressure, mild asthma, augmentin allergy, non alcoholic, non-smoker, and pre-diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 10:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, Patient stated that the shot hurt so bad not like any other shot she had before, she felt nauseous right on the spot. When she went home, she felt tired, weak and had headache, stomach cramps and her face was tingly but not red. At around 9 or 10 PM, She felt cold, had shiver, diarrhea, chills, and a fever of 100.8 F max. Her arm felt sore and looked bruised so she took Tylenol. By 21-MAR-2021, she had minor symptoms but fever went away, her arm was sore and she had diarrhea. Her symptoms completely resolved by 25-MAR-2021. On 08-APR-2021, patient went to see her Ophthalmologist to follow up on her minor low pressure Glaucoma and Dr. told her she had an Optic Nerve Damage. Dr. told her that her eye pressure is 10 or 11 and it did not make sense that her pressure was low but she had an optic nerve damage. Ophthalmologist suggested that this could be because her oxygen level was low or she had sleep apnea but patient regularly checked her oxygen (always around 98) and did not had sleep apnea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, bruised arm, tingly face, stomach cramps, shivering/chills/felt cold, sore arm, weakness, nauseous right on the spot, tiredness, headache, and fever on 25-MAR-2021, and the outcome of optic nerve damage was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421255-Covid-19 vaccine ad26.cov2.s-Optic Nerve Damage. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
70 2021-04-20 pain in extremity, discomfort Patient reported a sore arm directly after receiving the vaccine. She called the pharmacy to report ... Read more
Patient reported a sore arm directly after receiving the vaccine. She called the pharmacy to report the sore arm and concerns that she didn't think her arm should be that sore. The pharmacist went over the vaccine technique used by the technician who remembered the patient. Technique seemed appropriate, so we recommended patient follow-up with her PCP if the discomfort continued. Pharmacy let the patient know that discomfort in the arm for up to 7 days can occur and is not unusual. On 4/19/21, patient reported that she followed up with PCP, tried taking a Medrol Dose Pak and was then referred to doctor with sports medicine. The pharmacy called doctor for more information for the VERS reporting. Doctor had determined patient had injury of left shoulder with bursitis relating to vaccine administration and is a "well known phenomenon" per doctor. Patient continues to follow-up with doctor and will begin PT to help with the condition.
70 2021-04-20 pain in extremity States she developed leg pain 6 days after shot and didn't think it was anything to worry about unti... Read more
States she developed leg pain 6 days after shot and didn't think it was anything to worry about until she saw the J&J blood clot news and decided to get checked. Had appt and ultrasound on 4/19/2021 with NP. Found to have two non-occlusive, small blood clots in the right leg.
70 2021-04-21 pain in extremity LEG PAIN; This spontaneous report received from a patient concerned a 70 year old female. The patien... Read more
LEG PAIN; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leg pain was not reported. This report was non-serious.
70 2021-04-21 tingling, pain in extremity Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trach... Read more
Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trachea; sharp sudden onset headache; racing pulse 100 beats per minute; blood pressure 154/100. Because of the headache, I had the pharmacist take my BP. Upper palate was scratchy and irritated. Took 25 milligram tablet of Benedryl. Throat getting tighter but no shortness of breath. At 4:00 BP was 164/104, pulse still 100. At 4:00 took another 25 mg of Benedryl. BP remained high. Stayed for an hour. Turned down epi-pen because her breathing was fine. 5:15 BP still 164/104. Left site and started feeling itchy-- eyelids, lip, scalp. 7:00 BP had come down. 148/94, pulse 88; headache persisted. Took 650 mg of aspirin. 9:00 headache had lessened and BP was 138/80, pulse was 84. By 10:00, moderate headache. Slept. Woke up at 12:00 am with muscle pain in right leg. 3:30 am woke with bad headache, chilled, slight fever (99.6), rash on right trunk and upper abdomen. Took two more aspirin for headache. 8:00 am 130/76, normal temp, hives.
70 2021-04-22 nerve injury, nerve pain March 5th I received Johnson and Johnson vaccine March 8th developed fatigue and chest pains March ... Read more
March 5th I received Johnson and Johnson vaccine March 8th developed fatigue and chest pains March 12th I developed blisters on one half of my torso, March 15 my PA diagnosed me with shingles Today, about 6 weeks later the rash is almost gone but I still am being treated for chronic nerve pain
70 2021-04-23 burning sensation COLD SORES IN NASAL CAVITY; PAINFUL IN NASAL CAVITY; BUTTOCK CHEEK BURNING SENSATION; BUTTOCK CHEEK ... Read more
COLD SORES IN NASAL CAVITY; PAINFUL IN NASAL CAVITY; BUTTOCK CHEEK BURNING SENSATION; BUTTOCK CHEEK ITCHING SENSATION; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included cold sores in nose.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, once a total administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced buttock cheek burning sensation. On 05-MAR-2021, the subject experienced buttock cheek itching sensation. On 10-MAR-2021, the subject experienced cold sores in nasal cavity. On 10-MAR-2021, the subject experienced painful in nasal cavity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from buttock cheek burning sensation, and buttock cheek itching sensation on 05-MAR-2021, and had not recovered from cold sores in nasal cavity, and painful in nasal cavity. This report was non-serious.
70 2021-04-23 feeling cold ITCHING OF LEGS; SWOLLEN FACE, LEFT ARM (INJ. SITE) AND BOTH LEGS, SWELLED UP AND COVERED FROM HEAD-... Read more
ITCHING OF LEGS; SWOLLEN FACE, LEFT ARM (INJ. SITE) AND BOTH LEGS, SWELLED UP AND COVERED FROM HEAD-TO-TOE; RASH; FREEZING; HEADACHE; TIRED; NAUSEA; FEVER (101F); This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included bowel obstruction, hernia, diabetes, non alcoholic, non-smoker, penicillin allergy, and levaquin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced freezing. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced tired. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced fever (101f). On 20-MAR-2021, the subject experienced itching of legs. On 20-MAR-2021, the subject experienced swollen face, left arm (inj. site) and both legs, swelled up and covered from head-to-toe. On 20-MAR-2021, the subject experienced rash. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, tired, nausea, and fever (101f) on 18-MAR-2021, was recovering from freezing, and had not recovered from itching of legs, swollen face, left arm (inj. site) and both legs, swelled up and covered from head-to-toe, and rash. This report was non-serious.
70 2021-04-24 numbness Numbness in arms and face every day since 8 pm on April 08, 2021. More prevalent in the afternoon. ... Read more
Numbness in arms and face every day since 8 pm on April 08, 2021. More prevalent in the afternoon. I went to my Doctor on April 23, 2021, at 8:40 am for my regular check-up and I did inform them that I was having this reaction and I got no response.
70 2021-04-26 burning sensation, pain in extremity Patient reports a burning pain in her right leg from the hip to the knee area; not pinpoint pain, mo... Read more
Patient reports a burning pain in her right leg from the hip to the knee area; not pinpoint pain, more radiating; initial swelling but reports no longer swollen. Patient following up with primary care provider to see if this is related to history of back issues and radiating pain or something else.
70 2021-04-26 difficulty speaking Within 10 minutes of getting the vaccine I started having hay fever- like symptoms. Sinus drainage,... Read more
Within 10 minutes of getting the vaccine I started having hay fever- like symptoms. Sinus drainage, itchy, burning eyes, runny nose, scratchy throat, hoarse voice. This lasted for several hours. It again worsened during the night and next day I had bouts of nausea and some head ache.
70 2021-04-27 hypersensitivity of all senses, pain in extremity My skin became very sensitive to touch 4-5 days ago, then I noticed some pain in my left leg like m... Read more
My skin became very sensitive to touch 4-5 days ago, then I noticed some pain in my left leg like muscle overuse, then I woke up yesterday and found a rash. Dr. said its Shingles and said it is likely due to the vaccine.
70 2021-04-29 breast pain I experienced the day after my vaccine my right breast hurt so bad that I could not sleep. I also h... Read more
I experienced the day after my vaccine my right breast hurt so bad that I could not sleep. I also had a total breast reconstruction January 2012. My symptoms lasted a couple of days then they resolved.
70 2021-04-30 muscle spasms, weakness 2 weeks after vaccine had mild headache. 4 weeks after vaccine had cramping in R hamstring. 4-6 week... Read more
2 weeks after vaccine had mild headache. 4 weeks after vaccine had cramping in R hamstring. 4-6 weeks after vaccine started having balance issues, difficulty swallowing, weakness. LP as below which showed albuminocytologic dissociation. Clinical picture was concerning for Guillain-Barre syndrome. Patient started on IVIG.
70 2021-04-30 pain in extremity BLACK TOE; STUBBED HER RIGHT SMALL TOE; SEVERE HEADACHE; CHEST PRESSURE; CHEST PAIN; SORE ARM; NECK ... Read more
BLACK TOE; STUBBED HER RIGHT SMALL TOE; SEVERE HEADACHE; CHEST PRESSURE; CHEST PAIN; SORE ARM; NECK PAIN; MUSCLE ACHES; EXTREME TIREDNESS; SHORTNESS OF BREATH; HEAVY AND TIRED EYE; MULTIPLE BRUISE; BLURRED VISION IN LEFT EYE; FUNNY EYES; COUGHING; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 in march 2020, and concurrent conditions included migraine on the right or left side of her head, and sinus problem. he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included mecobalamin. On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced heavy and tired eye. On APR-2021, the subject experienced multiple bruise. On APR-2021, the subject experienced blurred vision in left eye. On APR-2021, the subject experienced funny eyes. On APR-2021, the subject experienced coughing. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced extreme tiredness. Laboratory data included: Platelet count (NR: not provided) Normal. On 08-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced chest pressure. On 10-APR-2021, the subject experienced chest pain. On 14-APR-2021, the subject experienced stubbed her right small toe. On 14-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced black toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, and chest pain on 11-APR-2021, and heavy and tired eye, blurred vision in left eye, funny eyes, coughing, black toe, stubbed her right small toe, sore arm, severe headache, muscle aches, and extreme tiredness on APR-2021, had not recovered from multiple bruise, and the outcome of shortness of breath and neck pain was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
70 2021-05-03 muscle spasms, feeling cold, facial pain Face pain especially jaw bones, headache, sharp shooting pain in right abdomen, icy cold, foot cramp... Read more
Face pain especially jaw bones, headache, sharp shooting pain in right abdomen, icy cold, foot cramps, extremely loud and fast heartbeat for about seven hours followed by moderately loud but still very fast heartbeat for several more hours, urination approximately every half hour throughout the night resulting dehydration.
70 2021-05-03 pain in extremity, tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
70 2021-05-03 pain in extremity First, the injection was far more painful than anticipated (and it bled down my arm). My arm immedi... Read more
First, the injection was far more painful than anticipated (and it bled down my arm). My arm immediately ached intensely. Approximately 10 minutes after injection, I began to sweat profusely, followed by intensifying extreme lightheadedness. I could not stand, or lift my head, as I would have definitely passed out. My shoulders and neck became extremely painful, as if ?frozen?, also preventing me from lifting my head. After about 35 minutes I very gradually began to recover. It was about an hour before I began to move around normally. Pharmacy and store staff debated calling the paramedics, but I refused. FYI, I had not been especially anxious about the vaccine, and I have never experienced such a reaction to anything in my life. It was a traumatic experience I would not wish to repeat.
70 2021-05-04 pain in extremity Patient received vaccine on 4/10/21. Went to ED, got IV placed due to side effects. Came to clinic ... Read more
Patient received vaccine on 4/10/21. Went to ED, got IV placed due to side effects. Came to clinic on 5/4/21 with right arm pain. Found to have occlusive cephalic vein clot.
70 2021-05-06 mild one side paralysis, tingling I had an event where my blood pressure was very high and the left side of my body became tingly and ... Read more
I had an event where my blood pressure was very high and the left side of my body became tingly and weak. I went to the doctor and stayed two nights for observation. They ran many diagnostic tests but nothing was diagnosed. I continued to have the tingling and weakness and began to feel it could be a pinched nerve in my back/shoulder. I went to a chiropractor and was treated twice for adjustments to my back, neck area and the tingling, weakness has not occurred again. I am monitoring my blood pressure at home and have a doctor check up scheduled for the end of this month. Confident it was not a medical event due to the Covid vaccine but still following up.
70 2021-05-10 burning sensation, numbness, muscle twitching, cold extremities My feet were very cold starting about a week after the vaccine. I noticed twitching and numbness in ... Read more
My feet were very cold starting about a week after the vaccine. I noticed twitching and numbness in my feet three weeks after the vaccine. I started taking a new medication Nortriptyline at the same time. I stopped the new medication and the symptoms persisted. I went to the the ER to rule out Guillen Barre syndrome. The numbness and tingling were working its way up my legs. It has been ten weeks and the feeling of numbness and tingling is as far up as my knees on both legs and I am having symptoms in my wrist. My feet are burning at night and it has been getting worse. I have seen specialists and I have a neurology consultation. My doctor suspects Chronic Inflamed Peripheral Neuropathy after ruling out RA, Lupus Multiple Myeloma and Diabetes.
70 2021-05-10 tremor After patient received the vaccine of Janssen I saw a hand shake. When I was going over side effect... Read more
After patient received the vaccine of Janssen I saw a hand shake. When I was going over side effect patient's hand was shaking more. I asked the patient if hand shaking was normal she stated no and she passed out. I was able to her upper body from falling. I asked her husband to hold her and I got an epinephrine 0.3mg Lot # 026a20aa exp 02/22. I injected epi into her left thigh. patient woke up after 20 second but she didn't have any memories what happened
70 2021-05-11 bell's palsy Headache - I had some neck pain. I don't remember - I might have some dizziness - I put them on the ... Read more
Headache - I had some neck pain. I don't remember - I might have some dizziness - I put them on the v-safe check-ins. I had to be taken by ambulance to the hospital on 4/17/2021 - I thought I was having a stroke. They said that I had developed bells palsy on the right side of my face. They gave me medication to use for one week. The symptoms that I was having went away less than two weeks later. They told me that Bells Palsy symptoms could last two weeks to six months. It's gone right now - I don't see any symptoms of it. I did have a virtual appt appt with my doctor -
70 2021-05-12 slurring, tingling, weakness, numbness 4/30/21: This patient comes in complaining of worsening low back pain. She has a history of severe ... Read more
4/30/21: This patient comes in complaining of worsening low back pain. She has a history of severe degenerative disease in his had surgery. She was scheduled to see her neurosurgeon last year however it got canceled due to the COVID-19. Patient states she saw her neurologist on Tuesday and was given injections which significantly helped. She states that her pain has returned however. She has had no trauma. No footdrop. No difficulty with her bowel or bladder. Patient states she only uses Tylenol arthritis at home. 5/1/21:The patient is a 70-year-old female presenting to the emergency department for back pain. She has a history of chronic back pain and states that has been worsening. She was recently seen here for the same complaint. She currently rates her pain 10/10 intensity. She reports that she has chronic numbness and tingling of her bilateral arms/hands and legs/feet. She states that this is also worsening. She denies any changes in bowel or bladder function or perineal numbness. She states that she has been using a walker at home and that she has tried to make an appointment with her neurosurgeon who previously operated on her but that she has been unable to get through to their office. She reports that she only called 1 time on a Friday. She is taking Tylenol at home for her pain and reports minimal relief. She denies any fevers or associated concerns at this time. 5/2/21: This is actually her 3rd visit in less than a week with this complaint. She was seen 2 other times at a outside facility. She states that she had back surgery about 10 years ago at Beaumont. She states she was supposed to see her neurosurgeon last year but this did not occur secondary to COVID-19. Her primary care physician had referred her to a neurologist did some injections ahead some relief of her back pain for a week or 2 but this is since worsened. She states that over last several days she has had increasing numbness and tingling in her feet as well as increasing weakness of her lower extremities as well as some now some new incontinence of urine when she stands up. She today she also complains some chest pain she attributes more from just amount of pain he has from her back. She rates her back pain as a 10/10 intensity. She did have 1 episode of a week or 2 ago where she slipped down and fell on her knee but did not hit her back directly. She did not hit her head. She describes the chest discomfort in her upper abdomen lower chest area. She is nauseated but not vomiting here. She denies any exertional dyspnea or orthopnea prior to this. She has had no recent fever chills. 5/11/21: The patient is an 70 y old female admitted on 5/4/2021. The patient was originally seen by Neurology on 05/07/2021 when she presented with diffuse weakness. She has a history of hyperlipidemia, hypertension and diabetes. The patient at that time described the acute onset of weakness ascending from the feet, then involving the legs and arms also associated with sensory symptoms that started about 2 weeks prior to her presentation. She also had persistent neck and back pain radiating to her arm and legs limiting her ability to walk. On neurologic examination at that time the patient had absent deep tendon reflexes in the lower extremities and trace reflexes at the biceps. She had significant weakness in the lower extremities and mild weakness in the upper extremities. She also had a dysarthric speech. Given the patient's CSF analysis showing protein elevation to 266 with no pleocytosis, wbc's were only for, there was support for a clinical diagnosis of acute inflammatory demyelinating poly radicular neuropathy or such variant. The patient was started on plasmapheresis and has received her 2nd session of plasmapheresis on 05/09/2021. She will have a total of 5 sections, one every other day. The patient also has hyponatremia, this can be seen in about 5% of patients with Guillain-Barre syndrome, we also do see pseudohyponatremia but this is in patients that have received IVIG.
70 2021-05-14 cold sweat Nausea Feeling sick Low blood pressure Clammy skin Signs and symptoms started 5 minutes after the ad... Read more
Nausea Feeling sick Low blood pressure Clammy skin Signs and symptoms started 5 minutes after the administering the vaccine. Vaccine administered at 12:22. At 12:27, the consumer complaints of nausea and feeling sick. Consumer remained awake, alert, and oriented. The consumer denies shortness of breath, chest pain, or difficulty breathing. Vital signs checked: BP 80/50 (manually), 86/50 (electronically), heart rate 65, oxygen saturation 94-97%. Consumer admitted taking her cardiac medications 10 to 15 minutes before we arrived for the in-home vaccine administration. The EMS arrived around 1:00 pm, assessed the consumer, BP remains low. At 01:40 pm, the consumer was transported to the hospital by the EMS. NOTE: Consumer states, she took cardiac medication 10-15 minutes before the vaccine was administered. She verbalized, the medication has not been take for a while (about 6 weeks), just resumed medication on 5/14/2021. BP reading 12:28 80/50 manually, 86/50 electronically 12:48 - 60/45 Called 911, fluid offered 12:55 - 161/87 1:00 - 104/54 EMS Arrived 1:05 - 106/54 1:06 - 108/70 1:15 - 77/45 1:40 - Consumer transported to the hospital by the EMS. Consumer remains awake, alert and oriented. Denies shortness of breath, chest pain, or difficulty breathing.
70 2021-05-25 pain in extremity, weakness Loss of energy/stamina for 20 days. Listless, sore arm, out of breath with simple daily activities
70 2021-05-25 tingling ANXIOUS; EXPERIENCING GROGGINESS; FEELING TIRED; FELT HORRIBLE; CHILLS; HEADACHE; NAUSEA; FELT ILL; ... Read more
ANXIOUS; EXPERIENCING GROGGINESS; FEELING TIRED; FELT HORRIBLE; CHILLS; HEADACHE; NAUSEA; FELT ILL; FEEL ALMOST PARALYZED; MUSCLE STIFFNESS AND ACHINESS / BACK STIFF AND ACHY; SLIGHT TINGLING IN BOTH LEGS; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and night sweats, and concurrent conditions included asthma (severe eosinophilia asthma), nasal polyps, high blood pressure, non smoker, and abstains form alcohol. The patient experienced drug allergy when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 16:00 for prophylactic vaccination. Concomitant medications included fluticasone propionate for asthma, zileuton for asthma, beclometasone dipropionate for drug used for unknown indication, fish oil for drug used for unknown indication, lisinopril for hypertension, and mometasone furoate for nasal polyps. On 2021, Laboratory data included: Body temperature (NR: not provided) 99.7 F. On JAN-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 18-MAY-2021, the subject experienced feel almost paralyzed. On 18-MAY-2021, the subject experienced muscle stiffness and achiness / back stiff and achy. On 18-MAY-2021, the subject experienced slight tingling in both legs. On 18-MAY-2021, the subject experienced felt ill. On 19-MAY-2021, the subject experienced felt horrible. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced headache. On 19-MAY-2021, the subject experienced nausea. On 21-MAY-2021, the subject experienced experiencing grogginess. On 21-MAY-2021, the subject experienced feeling tired. On an unspecified date, the subject experienced anxious. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feel almost paralyzed, muscle stiffness and achiness / back stiff and achy, slight tingling in both legs, felt horrible, chills, headache, and nausea on 20-MAY-2021, had not recovered from feeling tired, and experiencing grogginess, and the outcome of felt ill and anxious was not reported. This report was non-serious.This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and night sweats, and concurrent conditions included asthma (severe eosinophilia asthma), nasal polyps, high blood pressure, non smoker, and abstains form alcohol. The patient experienced drug allergy when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 16:00 for prophylactic vaccination. Concomitant medications included fluticasone propionate for asthma, zileuton for asthma, beclometasone dipropionate for drug used for unknown indication, fish oil for drug used for unknown indication, lisinopril for hypertension, and mometasone furoate for nasal polyps. On 2021, Laboratory data included: Body temperature (NR: not provided) 99.7 F. On JAN-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 18-MAY-2021, the subject experienced feel almost paralyzed. On 18-MAY-2021, the subject experienced muscle stiffness and achiness / back stiff and achy. On 18-MAY-2021, the subject experienced slight tingling in both legs. On 18-MAY-2021, the subject experienced felt ill. On 19-MAY-2021, the subject experienced felt horrible. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced headache. On 19-MAY-2021, the subject experienced nausea. On 21-MAY-2021, the subject experienced experiencing grogginess. On 21-MAY-2021, the subject experienced feeling tired. On an unspecified date, the subject experienced anxious. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feel almost paralyzed, muscle stiffness and achiness / back stiff and achy, slight tingling in both legs, felt horrible, chills, headache, and nausea on 20-MAY-2021, had not recovered from feeling tired, and experiencing grogginess, and the outcome of felt ill and anxious was not reported. This report was non-serious.
70 2021-05-26 pain in extremity, numbness Pain down left arm, severe pain, to hand and hand was numb, up all night could not sleep. Went to ER... Read more
Pain down left arm, severe pain, to hand and hand was numb, up all night could not sleep. Went to ER because she thought it might be her heart, it wasn't. Diarrhea was uncontrollable, messed herself a few times, never had time to run to restroom. Had to take a leave from work. Has been out of work a month because of the diarrhea. Had a colonoscopy, endoscopy, has to go back for another endoscopy, was in the hospital. Had blood in stool. Never experienced diarrhea or pain like that before. Afraid to go back to work or leave her house because the diarrhea continues and starts without warning.
70 2021-05-26 pain in extremity I got my vaccine twelve weeks ago and I still have problems with my left arm. I have lost a lot of t... Read more
I got my vaccine twelve weeks ago and I still have problems with my left arm. I have lost a lot of the range of motion and I get shooting pains when I try to do regular activities. At first I noticed pain when I reached back. It will not work if I try to reach for something and I get a shooting pain. I have tried taking Ibuprofen and icing it and it did not help. I also tried massage which helps a little for a short period of time.
70 2021-05-29 tingling, speech disorder, numbness 3 weeks after shot, numbness and tingling in right hand 3 weeks after that speech problems, trouble... Read more
3 weeks after shot, numbness and tingling in right hand 3 weeks after that speech problems, trouble swallowing, loss of use of hand, went to the ER on May 18 with a blood clot in brain causing stroke.
70 2021-06-09 pain in extremity, weakness Pain in right arm after receiving vaccination and increasing pain and weakness progression
70 2021-06-13 numbness PATIENT WAS OBSERVED FROM 0938 - 0953 WITH NO DISTRESS OR COMPLAINTS, PATIENT CALLED AT 1100 COMPL... Read more
PATIENT WAS OBSERVED FROM 0938 - 0953 WITH NO DISTRESS OR COMPLAINTS, PATIENT CALLED AT 1100 COMPLAINING OF NUMBNESS IN HAND AND FINGERS
70 2021-06-15 weakness At 1543, patient reported slight dizziness and general weakness to EMT. Patient given water and offe... Read more
At 1543, patient reported slight dizziness and general weakness to EMT. Patient given water and offered anti-gravity chair. Patient drank water and denied anti-gravity chair. At 1544, Paramedic assessed patient vitals: blood pressure 110/70 mmHg, pulse 66 beats/minute, and 93% SpO2. Patient reported history of fainting with prior vaccinations and a heart murmur. At 1600, Paramedic assessed patient vitals: 115/70 mmHg, pulse 73 beats/minute, and 93% SpO2. At 1610, Paramedic reassessed patient vitals: 115/70 mmHg, pulse 66 beats/minute, and SpO2 92%. Patient reported she wanted to leave. Patient reported feeling less dizzy and weak. Lead nurse educated patient on signs/symptoms of when to seek emergency care, to sign u on website and to follow up with primary care provider. At 1613, patient left facility with steady gait and unlabored respirations, accompanied by husband and Paramedic.
70 2021-06-28 migraine, tension headache After my shot, I expected some reaction or maybe none. Then in about a months time I was getting he... Read more
After my shot, I expected some reaction or maybe none. Then in about a months time I was getting headaches in the back of my head and then to the front like a migraine. Never had headaches at all for all my years. But, then more intense headaches on top of my head , tight ness in back of my head. I began to get very concerned!. Blood clot? Stroke? I called the Neurologist and made an appointment. I had to take 500mg of Tylenol and then went to 1,000 mg. and lay down . the pain was getting worse. in the a.m. then in the p.m. all day!
70 2021-07-03 flushing, pain in extremity on March 14, 2021 that evening, chills, fever. the next day, my face was completely flushed. It fade... Read more
on March 14, 2021 that evening, chills, fever. the next day, my face was completely flushed. It faded by the next day. On March 27 at 3:30 in the morning I work up with pain in my right leg , on the inner side of the leg by knee. later in the morning I notice a large bruise. On June 11, the same thing occurred on my left leg. I took a picture of the bruise on the right hand side of my knee. On July 3rd, the pain the back of both legs wall painful all day.
70 2021-07-08 cold sweat I GOT TIMED OUT WITH ALL THE DETAILS I GAVE ON MY FIRST ATTEMPT. THEREFORE, I WILL GET STRAIGHT TO ... Read more
I GOT TIMED OUT WITH ALL THE DETAILS I GAVE ON MY FIRST ATTEMPT. THEREFORE, I WILL GET STRAIGHT TO THE POINT. PATIENT WAS FOUND AFTER 15 MINUTES OF ADMINISTERING THE VACCINE TO BE PALE , COLD SWEAT AND NOT DOING WELL. I GAVE HER SOME WATER AND AT THAT POINT SHE LOST CONSCIOUSNESS FOR APPROX 30 SECONDS. 911 WAS CALLED. SHE COMPLAINED OF HAVING BLURRY VISION AND FEELING MALASE. EMTS AND FIRE DEPT. ARRIVED. HOOKED HER UP TO SEVERAL MONITORS. THE ONLY ONE THAT WAS OF CONCERN WAS HER BLOOD PRESSURE OF ABOUT 84/43. IT WAS RECOMMEDED THAT SHE BE TRANSPORTED AS SHE LIVES ALONE. SHE HAD ONLY EATEN EGGS AND POTATOES AT 11AM AND WAS FOSTERING 3 KITTENS. RAN ERRANDS ON A HOT DAY AND SAID SHE WAS HYDRATED.
70 2021-07-09 pain in extremity Patient called to report on going arm pain, possible inflammation with involvement of rotator cuff. ... Read more
Patient called to report on going arm pain, possible inflammation with involvement of rotator cuff. Patient has seen primary provider who suggested involvement of rotator cuff. Patient and provider are in monitoring mode to see if issue resolves.
70 2021-07-15 slurring, mild one side paralysis, inability to speak, face paralysis, facial paralysis HPI 70 y.o. female with pmh of HTN presenting w/aphasia and R sided facial and extremity weakness o... Read more
HPI 70 y.o. female with pmh of HTN presenting w/aphasia and R sided facial and extremity weakness onset 15m prior to EMS activation. Per EMS, pt may be on anticoagulation, unk meds. LKW 15 minutes prior to activation pt began slurring her speech and spoused noted R facial droop and R sided weakness. Patient unable to provide history based aphasia however cannot yes or no to questions. Pt is no longer taking medications for BP. Patient positive of intracranial hemorrhage.
70 2021-07-21 pain in extremity PAIN IN THE RIGHT KNEE; INFECTION IN THE TOP RIGHT TOOTH/SHOOTING PAIN IN THE TOP RIGHT FRONT TOOTH;... Read more
PAIN IN THE RIGHT KNEE; INFECTION IN THE TOP RIGHT TOOTH/SHOOTING PAIN IN THE TOP RIGHT FRONT TOOTH; PAIN IN RIGHT ARM/FEELING OF A SPLINTER MOVING UP DOWN IN THE RIGHT SHOULDER/PAIN MORE IN THE CUFF AREA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no history of other life style changes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. Concomitant medications included lisinopril. On 18-JUN-2021, the subject experienced pain in right arm/feeling of a splinter moving up down in the right shoulder/pain more in the cuff area. On 06-JUL-2021, the subject experienced infection in the top right tooth/shooting pain in the top right front tooth. On 12-JUL-2021, Laboratory data included: X-ray (NR: not provided) Tooth infection. On 19-JUL-2021, the subject experienced pain in the right knee. Treatment medications (dates unspecified) included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the right knee on 19-JUL-2021, and pain in right arm/feeling of a splinter moving up down in the right shoulder/pain more in the cuff area on 21-JUN-2021, and had not recovered from infection in the top right tooth/shooting pain in the top right front tooth. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
71 2021-03-05 flushing, feeling cold, tremor Woke up at 4AM on 03/05/2021 with shaking chills, feeling very cold, couldn't get warm. Shaking so... Read more
Woke up at 4AM on 03/05/2021 with shaking chills, feeling very cold, couldn't get warm. Shaking so bad I couldn't get whole sentences out. Body aches and stiffness, affected my walking. Did not take temperature at that time. Got back into bed with 2 blankets and a comforter and still couldn't sleep. Got up a 7AM - temp 102.2, shaking less but still feeling cold, body was hot to touch. I had a bad headache and body aches and stiffness were still there. I noticed at that time that I had a bright red flush on both cheeks and my nose that was hot to the touch. Took 600mg of Ibuprofen. Went back to bed feeling terrible. At 12 noon I got back up and temp was down to 99.7. Headache, body aches, stiffness, and "red flush" still on cheeks and nose. Went back to bed. Took more Ibuprofen at 7pm - temp was down to 98.7. Headache was better, body aches improved. Flushed hot face was still present. Went to sleep at 11:30PM and slept for 10 hours. Today, 03/06/21, all symptoms improved, no fever, redness of face is still present but less.
71 2021-03-09 tremor 6 hrs after shot, went into uncontrollable full body rigid tremors for about 30 minutes. Only reli... Read more
6 hrs after shot, went into uncontrollable full body rigid tremors for about 30 minutes. Only relieved by weight of heavy, confining blankets and a Tylenol. No chills or fever, just horrific tremors.
71 2021-03-11 muscle spasms 102+ fever muscle cramping, joint pain, severe headaches body sorness
71 2021-03-13 feeling cold 8:30 pm started - very cold/ then very bad body aches and slight headache; then dizziness and 4 hour... Read more
8:30 pm started - very cold/ then very bad body aches and slight headache; then dizziness and 4 hours later started vomiting for about 15 hours; slept all of next day and night/ waves of nausea; dizziness gradually faded after 24 hours, nausea faded after 26 hours
71 2021-03-14 numbness pt reports waking up the next morning with "amnesia" "didn't know where I was, forgetful, " numbness... Read more
pt reports waking up the next morning with "amnesia" "didn't know where I was, forgetful, " numbness radiating down her vaccinated arm, neck soreness
71 2021-03-14 pain in extremity After receiving the vaccine I got a sharp pain on head near neck, they had me to wait to make sure I... Read more
After receiving the vaccine I got a sharp pain on head near neck, they had me to wait to make sure I was ok, then I woke up and my shoulder and arm is in pain, the muscle hurts when i try to move my arm, my temp is 99.7 and I'm extremely tired. I took Tylenol.
71 2021-03-15 pain in extremity pt states that after she took the vax upon leaving the clinic she started getting woozy and could fe... Read more
pt states that after she took the vax upon leaving the clinic she started getting woozy and could feel the medicine going through her body all of the way down to her feet. She felt like her heart rate was up. She sat down to relax before driving home. Pt started taking ibuprofen immediately. The next day her right arm was sore, some fatigue and slight fever. All of her symptoms have subsided at this time.
71 2021-03-16 pain in extremity, muscle spasms Cramps/pain in legs.
71 2021-03-24 nerve pain, numbness Pt experiencing numbness and tingling on left side of tongue, left lower lip, and left index finger.
71 2021-03-28 pain in extremity Achiness in legs, then chills, and then my legs felt like they were on fire. The next day I had a te... Read more
Achiness in legs, then chills, and then my legs felt like they were on fire. The next day I had a terrible headache and very tired.
71 2021-03-30 numbness, tingling Immediately after the injection I had numbness and tingling in my left hand. 12 hours after the inj... Read more
Immediately after the injection I had numbness and tingling in my left hand. 12 hours after the injection I had severe chills, a severe headache, hand tremors and nausea which lasted for several hours. The headache (less severe) and hand tremors lasted for several days.
71 2021-04-04 feeling cold Cool feeling, dizziness, anxiety, Increased BP. H2O, snack, cool rag, breathing techniques to calm a... Read more
Cool feeling, dizziness, anxiety, Increased BP. H2O, snack, cool rag, breathing techniques to calm anxiety. Date: 3/22/2021 Problem: J&J Post-Vac Notes: Time: 1114 Pt c/o dizziness, coldness, and anxiety. BP: 207/130, HR 77, SpO2 98%, temp 97.2F. Offered pt water and crackers. Applied cool raag to pt neck. Coached pt through therapeutic breathing. Pt encouraged to wait 30 minutes. Time: 1147 Pt reports feeling better. Ambulated to restroom independently. Pt has no s/s of distress. BP 152/93, HR 68, SpO2 98%, temp 97.4F. pt teaching on s/s of allergic reactions. Pt ambulated out of building independently.
71 2021-04-04 pain in extremity NECK PAIN; ELBOW PAIN; HIGH BLOOD PRESSURE; LEFT ARM PAIN; SHOULDER PAIN; BODY ACHE; FATIGUE; This s... Read more
NECK PAIN; ELBOW PAIN; HIGH BLOOD PRESSURE; LEFT ARM PAIN; SHOULDER PAIN; BODY ACHE; FATIGUE; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) High. On 12-MAR-2021, the subject experienced body ache. On 12-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced shoulder pain. On 15-MAR-2021, the subject experienced left arm pain. On 16-MAR-2021, the subject experienced high blood pressure. On 27-MAR-2021, treatment medications included: paracetamol. On 01-APR-2021, the subject experienced elbow pain. On an unspecified date, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fatigue on 14-MAR-2021, was recovering from high blood pressure, had not recovered from shoulder pain, and left arm pain, and the outcome of neck pain and elbow pain was not reported. This report was non-serious.; Sender's Comments: V1: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
71 2021-04-04 pain in extremity She developed symptoms of right lower leg pain 4 days after receiving the vaccine. It then progress... Read more
She developed symptoms of right lower leg pain 4 days after receiving the vaccine. It then progressed to right chest pain, tachycardia, and shortness of breath. She was diagnosed with a DVT and PE.
71 2021-04-04 pain in extremity WARM AT SITE; WOKE HER UP; HURTS TO RAISE LEFT ARM; ACHY AT SITE; SPACY; This spontaneous report rec... Read more
WARM AT SITE; WOKE HER UP; HURTS TO RAISE LEFT ARM; ACHY AT SITE; SPACY; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included exercise induced asthma, not treated, codeine allergy, alcohol use, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug use. patient consumes 1-2 glasses of wine per week.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccinatio on left arm.. Concomitant medications included ascorbic acid, and . On 08-MAR-2021, the subject experienced spacy. On 23-MAR-2021, the subject experienced achy at site. On 25-MAR-2021, the subject experienced hurts to raise left arm. On 26-MAR-2021, the subject experienced woke her up. On an unspecified date, the subject experienced warm at site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacy on 08-MAR-2021, had not recovered from achy at site, and warm at site, and the outcome of woke her up and hurts to raise left arm was not reported. This report was non-serious.
71 2021-04-06 difficulty speaking While waiting in the car during post drive-up vaccine clinic observation period, patient developed i... Read more
While waiting in the car during post drive-up vaccine clinic observation period, patient developed itching in hands and hoarsness in throat. No difficulty breathing. No swelling of throat, lips or tongue. No hives. Vital signs were normal including oxygenation. 50mg Oral Benadryl was administered and improvement began within 10 minutes. 30 minutes after benadryl, hoarsness was gone and itching decreased. 45 minutes after benadryl, all symptoms were gone and patient was released from care by telehospitalist.
71 2021-04-07 pain in extremity Fatigue started 4/6/2021 then on 4/7/2021 upper right arm was very sore and hot to the touch. Sorene... Read more
Fatigue started 4/6/2021 then on 4/7/2021 upper right arm was very sore and hot to the touch. Soreness extended down arm and lasted most of the day on 4/7/2021. About 2pm I took 2 Tylenol and that started to minimize the ache, by bedtime my arm felt better.
71 2021-04-08 muscle spasms First 24 hours: Fever of 99.9; chills, sweats, spasms of muscles throughout body, extreme pain with... Read more
First 24 hours: Fever of 99.9; chills, sweats, spasms of muscles throughout body, extreme pain with muscle spasm, and muscle weakness. I could not go up and down steps as my legs would not hold me. Headache. Week 2 to present. Fatigue, I have to nap every day and I sleep 8 hours or more at night. Diarrhea, despite taking OTC medications to control. Dehydration and dizziness. I am now 4 weeks since my shot on March 4th and I continue to have these symptoms. I went to see my doctor and all lab tests are normal. There is no other diagnose reason for my continued symptoms. I wish I waited to get either the Pfizer shot or Moderna as I have not heard of these extreme and prolonged side effects from those shots.
71 2021-04-08 pain in extremity Tues. eve., after the vaccine, I got the CHILLS that lasted all night long! I woke up (Wed.) with ... Read more
Tues. eve., after the vaccine, I got the CHILLS that lasted all night long! I woke up (Wed.) with NAUSEA and took the "anti-nausea" pills that I had left over from when I had COVID (11 - 2020). My upper arm was now very sore, especially when I tried to lift it. I took my temp. and I had a FEVER (101). On Thurs., my temp. went down to 99.5 and the nausea was gone. Today (Fri.), I woke up with pain on my shoulder (over the injection site). I took Advil and iced it and it is now much better (this eve.). The only side effect I have now is the pain in my arm (mostly when I lift it). I am eating better and sleeping better now.
71 2021-04-08 pain in extremity SORENESS IN ELBOW, WRIST AND KNUCKLES; SORENESS IN ARM, HAND AND FINGERS; INJECTION SITE SORENESS; D... Read more
SORENESS IN ELBOW, WRIST AND KNUCKLES; SORENESS IN ARM, HAND AND FINGERS; INJECTION SITE SORENESS; DIFFICULTY USING HAND; SWOLLEN SHOULDER; INJECTION SITE BRUISING; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient received Tylenol unspecified (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 31-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the patient experienced injection site bruising. On 02-APR-2021, the patient experienced difficulty using hand. On 02-APR-2021, the patient experienced swollen shoulder. On 02-APR-2021, the patient experienced injection site soreness. On 03-APR-2021, the patient experienced soreness in arm, hand and fingers. On 04-APR-2021, the patient experienced soreness in elbow, wrist and knuckles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with Tylenol unspecified was not reported. The patient had not recovered from injection site soreness, difficulty using hand, swollen shoulder, injection site bruising, soreness in elbow, wrist and knuckles, and soreness in arm, hand and fingers. This report was non-serious.
71 2021-04-09 weakness, cold sweat Starting at 2:00am on 4/9/2021, Patient reports cold sweat and headache. She attempted to go to wor... Read more
Starting at 2:00am on 4/9/2021, Patient reports cold sweat and headache. She attempted to go to work on 4/10/21 but felt weakness when walking so patient went home. She is still experiencing headache, weakness, and some diarrhea.
71 2021-04-10 migraine Severe diarrhea, vomiting, migraine headache, chills and fever for two days
71 2021-04-12 numbness From 04/04/21 until now: Bad headache, elevated blood pressure, numbness in face and extremities, d... Read more
From 04/04/21 until now: Bad headache, elevated blood pressure, numbness in face and extremities, dizziness.
71 2021-04-13 unresponsive to stimuli Patient had her Johnson and Johnson Covid 19 vaccine on Friday April 9, 2021. Prior to the vaccine p... Read more
Patient had her Johnson and Johnson Covid 19 vaccine on Friday April 9, 2021. Prior to the vaccine patient displayed no noticeable signs of deteriorating health. Over the next two days, friends of the patient attempted to contact her with no success. Finally after several hours of no contact, the grandchildren of the patients friend went to her apartment and found the patient lying on the couch unresponsive. When the patient was found, her leg was swollen. She was cold and not breathing. She passed away after receiving the Johnson and Johnson vaccine.
71 2021-04-15 weakness I had a major MS exacerbation. Weakness, cognitive function, all over sick
71 2021-04-15 slurring TIA, RASH, BLURRED VISION, MOUTH TINGLING, TROUBLE WITH SPEECH
71 2021-04-15 pain in extremity shortness of breath, leg pain.
71 2021-04-17 burning sensation Burning, Aching, Capsulated.
71 2021-04-19 weakness, muscle spasms beginning the day after the vaccine Patient experienced dairrhea, extreme nausea, cramps, coughing a... Read more
beginning the day after the vaccine Patient experienced dairrhea, extreme nausea, cramps, coughing and weakness. This persisted for 3 days. Patient suffered a stroke or multiple strokes either 5 or 6 days after administration of the vaccine. She has since died as a result of the strokes.
71 2021-04-20 feeling hot, pain in extremity TASTE ALTERATION; SWOLLEN ARM; RED ARM; HOT ARM; HEADACHES; FATIGUE; FEVER; SORE ARM; INFLAMED ARM; ... Read more
TASTE ALTERATION; SWOLLEN ARM; RED ARM; HOT ARM; HEADACHES; FATIGUE; FEVER; SORE ARM; INFLAMED ARM; ITCHY ARM; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with Percocet (oxycodone hydrochloride;paracetamol), morphine ,diphenhydramine, Demerol (pethidine hydrochloride) ,Biaxin (clarithromycin), Levaquin (levofloxacin). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced itchy arm. On APR-2021, the subject experienced inflamed arm. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced swollen arm. On 10-APR-2021, the subject experienced red arm. On 10-APR-2021, the subject experienced hot arm. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced taste alteration. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches, and fatigue on 12-APR-2021, had not recovered from taste alteration, swollen arm, red arm, hot arm, and fever, and the outcome of itchy arm, sore arm and inflamed arm was not reported. This report was non-serious.
71 2021-04-20 speech disorder 4/17/21 around 5 pm lost consciousness and did not knowingly awaken until a friend came to her home ... Read more
4/17/21 around 5 pm lost consciousness and did not knowingly awaken until a friend came to her home and said she was sitting on the bathroom floor and responding inappropriately. Pt has no memory of any events that occurred between Sat evening through Sunday morning . Feeling of being in a fog is slowly improving.
71 2021-04-21 numbness, pain in extremity The patient's weight, height, and medical history were not reported.The patient received covid-19 va... Read more
The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: alprazolam. On 05-MAR-2021, the subject experienced numbness from the waist down for 4 hours. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced emotional fatigue. On 06-MAR-2021, the subject experienced physical fatigue/exhaustion. On 07-MAR-2021, the subject experienced depression. On 07-MAR-2021, the subject experienced anxiety. On 07-MAR-2021, the subject experienced short term memory loss. On 07-MAR-2021, the subject experienced right hand not work properly, she cant hold things properly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness from the waist down for 4 hours, was recovering from depression, and anxiety, had not recovered from physical fatigue/exhaustion, emotional fatigue, right hand not work properly, she cant hold things properly, and short term memory loss, and the outcome of body aches was not reported. This report was non-serious.
71 2021-04-22 pain in extremity PERSISTED ARM PAIN; This spontaneous report received from a patient concerned a 71 year old female. ... Read more
PERSISTED ARM PAIN; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and nonsmoker. The patient experienced drug allergy when treated with codeine, and hydrocodone bitartrate/paracetamol for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced persisted arm pain. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persisted arm pain. This report was non-serious.
71 2021-04-23 speech disorder, tingling On 4/16/2021 went to the emergency room with high blood pressure that was noted as a "hypertensive e... Read more
On 4/16/2021 went to the emergency room with high blood pressure that was noted as a "hypertensive emergency". Was admitted into the hospital the next day where a CT scan confirmed that a blood clot in the brain occurred which led to a basal ganglia stroke. After a 5 day stay in the hospital, patient is now in a full time rehab facility to attempt to recover her cognitive and speech skills, while also attempting to regain use of her right hand which is currently not functioning due to the stroke.
71 2021-04-26 pain in extremity, tingling, numbness NUMBNESS OF EXTREMITIES; TINGLING OF EXTREMITY; MILD SORE ARM; TIREDNESS; This spontaneous report re... Read more
NUMBNESS OF EXTREMITIES; TINGLING OF EXTREMITY; MILD SORE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and auras with migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Blood test (NR: not provided) cleared of blood clots, Ophthalmological examination (NR: not provided) clear eyes, and Screening test (NR: not provided) clear stomach, carotids were clear. On 09-APR-2021, the subject experienced mild sore arm. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced numbness of extremities. On 10-APR-2021, the subject experienced tingling of extremity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness of extremities, and tingling of extremity on APR-2021, and mild sore arm on 11-APR-2021, and the outcome of tiredness was not reported. This report was non-serious.
71 2021-04-27 muscle spasms Fever and aches next day, lasting about 24 hours. Also, 3 weeks later developed unexplained muscle ... Read more
Fever and aches next day, lasting about 24 hours. Also, 3 weeks later developed unexplained muscle spasm in the mid and lower back which I currently am experiencing.
71 2021-04-29 feeling cold Patient exhibited stress and anxiety about receiving vaccination. After administration, she said th... Read more
Patient exhibited stress and anxiety about receiving vaccination. After administration, she said that the site hurt more than expected and said she was feeling dizzy. Cold wet paper towels were offered to her to place on her face. Next, reported feeling strange, shaky. Leaned forward with head low. Instant cold pack was placed on back of neck. Over next five to ten minutes patient's anxiety increased, as did shakiness. Blood pressure readings were taken and elevated, as was heartrate, but not at hypertensive crisis. Patient could breathe and speak. She contacted someone to assist her with leaving, but when the ETA seemed too long, she agreed to have us contact EMS. Her condition seemed to improve and decline several times before assistance arrived. She expressed concern about the elevated BP readings. A second cool pack was administered until she next reported feeling cold and chilly, with shakiness. She mentioned that her abdomen also felt cold, which was strange. EMS arrived and transported patient approximately 30 minutes post administration.
71 2021-05-02 numbness, facial paralysis pt says she had a few episodes of feeling dizzy before having a stroke. Pts right hand became numb,... Read more
pt says she had a few episodes of feeling dizzy before having a stroke. Pts right hand became numb, she had some confusion, she was nauseated and had a severe headache several days prior to going to the emergency room. On 3/28/21 her face was dropping on the right side so was brought ER. She was admitted and given CT and multiple test. She was treated for a Stroke and stayed for about 3 days. She was discharged to FU w/ Neurologist next week.
71 2021-05-06 pain in extremity, weakness I started to have a heavy feeling in my right arm. On the fourth day it became worse, and my arm was... Read more
I started to have a heavy feeling in my right arm. On the fourth day it became worse, and my arm was really stiff and heavy. I was taking Advil and it didn?t help much. I went to the doctor on the sixth day. The NP thought it was a pinched nerve because it was my whole arm from the neck down. On the tenth day it started to affect my other arm which was the side that I got the shot in. I had no strength in my arms and my husband had to help me dress. It was almost two weeks after the shot I went back to the doctor. I was prescribed Meloxicam and an Arthritis cream and it did not help. Blood work did not show any definitive problem. Gabapentin and Advil did help a little. Three weeks after the shot the pain started to move to my legs as well. for one week. The pain is not as bad but now it is in my arms all the way into my neck and shoulders. It has been seven weeks since the shot and now the pain is still in my right arm and into my neck and shoulder blade. I still have good range of motion right now.
71 2021-05-06 pain in extremity Pain in hands, middle finger joint issue, forearms hurting, both shoulders and neck pain, ankle pain... Read more
Pain in hands, middle finger joint issue, forearms hurting, both shoulders and neck pain, ankle pain and shin pain? seemed like most major joints? most of these bilateral. No treatment yet. Diagnosed with polyarthralgia.
71 2021-05-15 cold sweat Severe burning pain of back (skin only not internal). Two days later skin peeled off as a sunburn wo... Read more
Severe burning pain of back (skin only not internal). Two days later skin peeled off as a sunburn would. Also change in personal body odor (not unpleasant just different) - obvious to other family members not just me. It's 6 days since vaccine and I'm still feeling clammy.
71 2021-05-18 cold sweat, unresponsive to stimuli PATIENT GOT DIZZY WITHIN 5 MINUTES OF RECEIVING VACCINE-BECAME UNRESPONSIVE FOR ABOUT 30 SECONDS. SH... Read more
PATIENT GOT DIZZY WITHIN 5 MINUTES OF RECEIVING VACCINE-BECAME UNRESPONSIVE FOR ABOUT 30 SECONDS. SHE CONTINUED TO BE DIZZY/FAINT AND HAD A COLD SWEAT. PT WAS NOT INJURED WITH LOSS OF CONSIOUSNESS. CALLED 911, EMS ARRIVED AND TOOK PATIENT TO THE HOSPITAL. WHILE WAITING FOR EMS BLOOD PRESSURE AND HR CHECKS WERE PERFORMED WHILE PATIENT WAS IN LAYING DOWN POSITION.
71 2021-05-18 pain in extremity PAIN IN NECK; JOINT PAIN/ MIDDLE FINGER JOINT PAIN; PAIN IN BOTH CHINS,SHOULDER, FOREARMS AND HANDS;... Read more
PAIN IN NECK; JOINT PAIN/ MIDDLE FINGER JOINT PAIN; PAIN IN BOTH CHINS,SHOULDER, FOREARMS AND HANDS; PAIN IN BOTH ANKLES; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chin pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced pain in neck. On 2021, the subject experienced joint pain/ middle finger joint pain. On 2021, the subject experienced pain in both chins, shoulder, forearms and hands. On 2021, the subject experienced pain in both ankles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain/ middle finger joint pain, pain in neck, pain in both ankles, pain in both chins, shoulder, forearms and hands, and headache. This report was non-serious.
71 2021-05-20 tremor, weakness Starting -4/12/2021 - initial symptoms cycled through over the first four weeks. Fever, chills, ach... Read more
Starting -4/12/2021 - initial symptoms cycled through over the first four weeks. Fever, chills, aches, pains, shooting pain in ears (first 9 days); uncontrollable shaking, erratic heart beat (April 17, 18); severe head and neck ache (lasted 2 days), resting pulse 100, head cold, diarrhea, cough, fatigue, weakness, chest tightness, pneumonia (X-ray on 04/30/2021), premature heart beat (EKG on 05/17/2021). As of 05/21/2021, still have heart beat irregularities, weakness, and fatigue.
71 2021-05-21 pain in extremity I am diabetic so symtoms are like low blood sugar..I PASS OUT, SWEAT, COLD, DIZZY, MUSCLE PAINS, CON... Read more
I am diabetic so symtoms are like low blood sugar..I PASS OUT, SWEAT, COLD, DIZZY, MUSCLE PAINS, CONFUSED, VERY SLEEPY, PAIN IN EUSTACHIAN TUBE , HEADACHE, TOE PAIN,
71 2021-05-24 pain in extremity, numbness BLOOD CLOTS IN BOTH ARMS; NUMBNESS IN BILATERAL ARMS; REDNESS ON BOTH LEGS; SWELLING OF BOTH LEGS; P... Read more
BLOOD CLOTS IN BOTH ARMS; NUMBNESS IN BILATERAL ARMS; REDNESS ON BOTH LEGS; SWELLING OF BOTH LEGS; PAIN IN BOTH LEGS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer. The patient experienced drug allergy when treated with hydrocodone, and oxycodone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: unknown) dose was not reported, 1 total administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in 2021, the patient felt numbness on both arms. Numbness got worse and patient went to emergency room. On an unspecified date in 2021, Laboratory data included: MRI brain results of which were pending. On an unspecified date in MAR-2021, a week after the vaccination patient went to emergency room due to redness, swelling, and pain on both legs. The doctor prescribed antibiotics which relieved those symptoms and was encouraged to get blood circulation assessed once patient returned to home. On 17-MAY-2021, patient got hospitalized, and on same day, ultrasound test showed a blood clot in each arm. Patient underwent chest X-ray and a test with and without contrast for the lungs. It was reported that patient was started on anticoagulants and physical therapy. On 18-MAY-2021, ultrasound of legs was negative for blood clots. On 19-MAY-2021, test in a machine with and without contrast to look at lungs (Lung scan) was within normal limits. On 19-MAY-2021, the patient got discharged from hospital. Patient stated that, consulted two doctors if it may have been the Janssen covid-19 vaccine that caused this and doctors said possibly and recommended that patient should report the information. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from redness on both legs, swelling of both legs, and numbness in bilateral arms, and had not recovered from pain in both legs, and blood clots in both arms. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210540231-COVID-19 VACCINE AD26.COV2.S-BLOOD CLOTS IN BOTH ARMS, NUMBNESS IN BILATERAL ARMS. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
71 2021-05-25 weakness I had a headache that bothered me I mean it hurt. Then I got diarrhea, sick on the stomach and real ... Read more
I had a headache that bothered me I mean it hurt. Then I got diarrhea, sick on the stomach and real weak and watery mouth. Just didn't feel right, feverish, real thirsty almost like the flu and my body would ache, like going up and down the hill. For a while I was really totally upset and said I shouldn't have gotten the shot. All I wanted to do was lay down and I got so weak. I don't think I would take another shot again if they come out with a booster.
71 2021-05-27 pain in extremity Muscle aches and pains Some severe Calf pain, tired still, chills still, The pains keep changing ... Read more
Muscle aches and pains Some severe Calf pain, tired still, chills still, The pains keep changing to different parts
71 2021-05-31 pain in extremity On 4/07/2021 I had pains in my top arm down to my elbow
71 2021-06-02 pain in extremity DIARRHEA/MUSHY POOP; CRAMPING IN STOMACH WHEN EATS; DIDN'T EAT; SORE ARM; FEELS DIZZY; FLU LIKE SYMP... Read more
DIARRHEA/MUSHY POOP; CRAMPING IN STOMACH WHEN EATS; DIDN'T EAT; SORE ARM; FEELS DIZZY; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced feels dizzy. On 28-MAY-2021, the subject experienced flu like symptoms. On 28-MAY-2021, the subject experienced sore arm. On 29-MAY-2021, the subject experienced diarrhea/mushy poop. On 29-MAY-2021, the subject experienced cramping in stomach when eats. On 29-MAY-2021, the subject experienced didn't eat. The action taken with covid-19 vaccine was not applicable. The patient was recovering from diarrhea/mushy poop, cramping in stomach when eats, and sore arm, had not recovered from feels dizzy, and flu like symptoms, and the outcome of didn't eat was not reported. This report was non-serious.
71 2021-06-10 nerve pain, pain in extremity Two weeks after the vaccine on March 29,2021 all day that day right arm was stiff and felt like ever... Read more
Two weeks after the vaccine on March 29,2021 all day that day right arm was stiff and felt like every nerve in her body was in pain. stated she felt like somebody was ripping her arm off it. Tried taking extra strength acetaminophen but it still didn't work. Range of motion with moving her arm didn't bother her at all it was just pain in her arm.
71 2021-06-15 migraine with aura trouble drinking water nausea rainbow migraine's chill
71 2021-06-18 weakness, migraine with aura SICKNESS; SEVERE MIGRAINE THAT FLARED UP WITH CONSTANT PAIN AND EXTREME LIGHT SENSITIVITY THAT AFFEC... Read more
SICKNESS; SEVERE MIGRAINE THAT FLARED UP WITH CONSTANT PAIN AND EXTREME LIGHT SENSITIVITY THAT AFFECTED THE VISION AND ABILITY TO TEACH, WRITE OR LOOKING AT THE SCREEN; ENERGY AFFECTED; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sickness, severe migraine that flared up with constant pain and extreme light sensitivity that affected the vision and ability to teach, write or looking at the screen, and energy affected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe migraine that flared up with constant pain and extreme light sensitivity that affected the vision and ability to teach, write or looking at the screen, and energy affected, and the outcome of sickness was not reported. This report was non-serious. This parent/child case is linked to 20210632026.
71 2021-06-22 weakness, muscle spasms periodic neck stiffness, leg cramps, some rapid heart rate,memory loss, continual itching on torso a... Read more
periodic neck stiffness, leg cramps, some rapid heart rate,memory loss, continual itching on torso and head, not energy and sleepiness after a good nights sleep, low energy. I am afraid of long term results. Wish I had not received it
71 2021-07-12 weakness, pain in extremity Severe pain legs, feet, back, arms, hands .Low grade temp 99.8 Malaise, weakness.
72 2021-03-06 feeling cold shot given 3-5-21 3-7-21 at 2:00 am was woken up by bad muscle and joint pains. But I was freezing. ... Read more
shot given 3-5-21 3-7-21 at 2:00 am was woken up by bad muscle and joint pains. But I was freezing. I had the chills very badly I sleep with an electric blanket, but I had not had chills in years. I was very sore and cold, but did not do anything until 4:00am. I went and got an expired prescription of oxycontin. I took 2 and went back to bed. I woke up at 6 and was fine. So it lasted maybe 4 hours.
72 2021-03-06 tremor Patient reports bad chills, shaking, headache, but no fever starting 7 hours post administration of ... Read more
Patient reports bad chills, shaking, headache, but no fever starting 7 hours post administration of COVID-19 vaccine. Symptoms resolved within 36 hours. Patient had new onset of nausea/diarrhea 48 hours post administration. Patient advised to hydrate and monitor GI symptoms, and call provider if symptoms last more than 24 hours.
72 2021-03-12 weakness Patient complained of shortness of breath, general weakness, dizziness, chest pain which she specifi... Read more
Patient complained of shortness of breath, general weakness, dizziness, chest pain which she specifically described as ?angina.? Patient stated symptoms lasted for about 30 minutes then resolved. No medications administered in response to event.
72 2021-03-19 pain in extremity MILD SORE ARM, TIREDNESS, NAUSEOUS WITHIN FEW HOURS. 26 HOURS LATER SEVERE REACTION BEGAN. RAPID H... Read more
MILD SORE ARM, TIREDNESS, NAUSEOUS WITHIN FEW HOURS. 26 HOURS LATER SEVERE REACTION BEGAN. RAPID HEART BEAT 154 BMP AND A HARD KNOT (BOUT SIZE OF DIME) FORMED IN LEFT PALM (ARM OF SHOT). TOOK FLECAINIDE 150 MG THAT REDUCED RATE TO 90 BPM BY 6 PM THAT NITE. HEART WAS NORMAL BY NEXT MORNING. THE HARD KNOT IN LEFFT PALM STILL REMAINS 10 DAYS LATER.
72 2021-03-24 cold sweat, weakness Many lasting for 2 weeks - pain, nausea, diarrhea, extreme weakness and fatigue, dizziness, fever an... Read more
Many lasting for 2 weeks - pain, nausea, diarrhea, extreme weakness and fatigue, dizziness, fever and chills, cold sweats,, headache, brain fog, dyspnea on exertion, dry mouth. Medicated with Tylenol, bananas, oatmeal and herbal tea. Documented on pdf form, but unable to use "continuation page", so added sheet that unable to attach. Will try again to upload and send separately to this. NO forms given to me at pharmacy for reporting anything. I called several times and left messages, but no return call. Sent email, but response saying unable to help at this time. Very frustrating as I continued having severe symptoms and unable to get help. Finally feeling better enough today to send form.
72 2021-03-25 weakness Patient reported fevers as high as 105 at rehab and myalgias along with weakness, She was subsequent... Read more
Patient reported fevers as high as 105 at rehab and myalgias along with weakness, She was subsequently admitted to the hospital for these symptoms.
72 2021-03-27 weakness Fever, chills, racing heartbeat, headache, muscle pain, weakness, diarrhea, muscle and joint pain.
72 2021-03-28 pain in extremity arm pain x 2-3 days, then metallic taste started 1 week after vaccination
72 2021-03-29 breast pain Wednesday night on 3/11/2021 around 9 pm dull chest pain under and around left breast. Called docto... Read more
Wednesday night on 3/11/2021 around 9 pm dull chest pain under and around left breast. Called doctor on Thursday morning. Spoke with Dr in the afternoon. Office visit on Saturday morning. Administered EKG ... diagnosis ... Pericarditis ... prescribed Famotidine 40mg and Naproxen 250mg.
72 2021-04-01 pain in extremity On Wednesday, March 10, 2021,I started having muscle pain throughout my left and right legs. Things... Read more
On Wednesday, March 10, 2021,I started having muscle pain throughout my left and right legs. Things and calves were like walking on raw nerve ends. I had all types of tests, x-rays, MRI?s and dr. visits to try to find the cause. This pain continued through March 31, until I was finally given a prescription for a steroid by my internist who believed this pain was being caused by the Johnson & Johnson covid 19 vaccination because of the time frame between the vaccine I was given and when the symptoms began. The pain while on steroids has disappeared. I am, as of this date, on the third day of a seven day course of the steroid medication. The pain subsided on day two of the medication.
72 2021-04-04 weakness ER 3/17 HPI: 72 y.o. female who presents with generalized weakness and not feeling well. Patient st... Read more
ER 3/17 HPI: 72 y.o. female who presents with generalized weakness and not feeling well. Patient states that she had her 1st dose of COVID-19 vaccine about a week ago and since then has not felt well. She denies fever or chills, she denies any arthralgias or myalgias, she has had some nausea and vomiting but none in the last couple of days. There has been no diarrhea. There have been no urinary symptoms. 3/22/21 Inpt Admission hpi 72 y.o. female who presents with shortness of breath and hemoptysis. Patient has known history of COPD and also has a history of squamous cell carcinoma of the lung that is in remission. Patient reports she has noticed increasing shortness of breath for the past several weeks. She states the got worse around the noon time today. Patient reports she began having some hemoptysis today. Patient denies any chest pain or palpitations. Patient denies any fevers or chills. Patient denies any sinus congestion or nasal drainage. Patient denies any headaches, myalgias, or loss of sense of taste and smell. Patient does report a 4 day history of intermittent diarrhea. She denies any nausea or vomiting. Patient has had COVID-19 vaccination. Of note, patient's family reports she has lost 10 lb in the past 30 days. 3/30/21 Deceased
72 2021-04-06 feeling hot, pain in extremity WARMTH IN THE ARM; ACHINESS AND PAIN IN THE ARM AROUND THE INJECTION AREA; INJECTION SITE PAIN; Thi... Read more
WARMTH IN THE ARM; ACHINESS AND PAIN IN THE ARM AROUND THE INJECTION AREA; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was not reported and height was 167 centimeters. The patient's concurrent conditions included penicillin allergy, non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient have no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 05-MAR-2021 13:45 on left arm for prophylactic vaccination. Concomitant medications included amlodipine for blood pressure. On 05-MAR-2021, the subject experienced injection site pain. On 23-MAR-2021, the subject experienced warmth in the arm. On 23-MAR-2021, the subject experienced achiness and pain in the arm around the injection area. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on MAR-2021, and had not recovered from achiness and pain in the arm around the injection area, and warmth in the arm. This report was non-serious. Additional information was received from patient on 31-MAR-2021.The following information was updated and incorporated into the case: Patient height, medical history (penicillin allergy) added, Concomitant product amlodipine added. Vaccination time added, Expiry date added.
72 2021-04-08 weakness Chills that kept me from sleeping, muscle aches and pains, lowgrade (100 degrees) fever, lack of ene... Read more
Chills that kept me from sleeping, muscle aches and pains, lowgrade (100 degrees) fever, lack of energy, sleepiness
72 2021-04-08 feeling hot, feeling cold Around 5:30 pm on Friday night, I started feeling really cold; couldn't get warm for 2 hours. Then I... Read more
Around 5:30 pm on Friday night, I started feeling really cold; couldn't get warm for 2 hours. Then I started getting a fast heart rate; checked this around 7 pm; BP was 181/80 and heart rate was 135. I was starting to feel warm along with being cold. I had a gradually increasing temperature; checked it around 8:30 pm; was 102.1; took 2 tylenol and temperature slowly started going down. My heart would not slow down; I sat in my recliner and kept deep breathing and had calming herbal tea; was afraid to go to the ER due to Covid. After more than 4 hours with a racing heart, I felt exhausted and laid down around 12:30 a.m. and fell asleep. I woke around 3 am with nausea and soaking wet pajamas from sweating. I fell asleep again and woke around 7 am; I felt very tired, woozy and my heart hurt. I felt a bit more normal after a few days. I still feel a bit dizzy and light headed. I was concerned when I later heard some J&J vaccines were contaminated; on 4/2/21, I called the pharmacy because the number they wrote on my card, 1805D18 wasn't clear; they told me this # was incorrect and should be 037A21B and couldn't explain why this was so. They were going to check into this and call me; I called them again on 4/5/21 and was told the correct # was 043A21A and that the vaccine was from the Netherlands. They couldn't offer any more information or explain why the initial # was incorrect. I find this concerning and have been unable to find an answer.
72 2021-04-09 pain in extremity, coordination abnormal HEADACHE; PAIN IN THE HEEL; FEVER; PAIN AT INJECTION SITE; FELLING UNCOORDINATED; PAIN RADIATING TO ... Read more
HEADACHE; PAIN IN THE HEEL; FEVER; PAIN AT INJECTION SITE; FELLING UNCOORDINATED; PAIN RADIATING TO THE NECK; DIZZY; SHOOTING PAIN IN EAR; PAIN IN THE ANKLE; MUSCLE PAIN; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteo-arthritis, fibromyalgia, kidney stone, penicillin allergy, ibuprofen allergy, corticosteroid allergy and erythromycin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 14:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizzy. On 2021, the subject experienced shooting pain in ear. On 2021, the subject experienced pain in the ankle. On 2021, the subject experienced muscle pain. Treatment medications included: acetylsalicylic acid. On 25-MAR-2021, the subject experienced felling uncoordinated. On 25-MAR-2021, the subject experienced pain radiating to the neck. On 25-MAR-2021, the subject experienced pain at injection site. On 25-MAR-2021 20:00, the subject experienced fever. On 31-MAR-2021, the subject experienced pain in the heel. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, felling uncoordinated, and fever, had not recovered from headache, and the outcome of pain at injection site, pain in the heel, pain in the ankle, muscle pain, shooting pain in ear and pain radiating to the neck was not reported. This report was non-serious.
72 2021-04-12 weakness, seizure SEIZURE; JOINTS LOCKED UP/WHOLE BODY LOCKED UP; NO APPETITE; SWEATING; BARELY BEEN OUT OF BED/HOME B... Read more
SEIZURE; JOINTS LOCKED UP/WHOLE BODY LOCKED UP; NO APPETITE; SWEATING; BARELY BEEN OUT OF BED/HOME BOUND; CHILLS; WEAKNESS; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, after 23:00 the patient began shaking and had seizure, her mouth was drawn up. On the same day, the patient experienced fever, chills, sweating, weakness, no appetite and her whole body locked up and her joints locked up. According to the patient, she had barely been out of bed and had been home bound since vaccine was administered. The patient visited doctor/healthcare professional's office for events seizures, shaking, mouth drawn and fever. It was reported that, on 02-APR-2021, a nurse came to the patient's home and tried to encourage her to go to the hospital but she declined. On the day of this report, the patient had an appointment via phone video for her pulmonologist and with her primary care physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joints locked up/whole body locked up on 28-MAR-2021, was recovering from fever, chills, and sweating, had not recovered from seizure, no appetite, and barely been out of bed/home bound, and the outcome of weakness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: covid-19 vaccine ad26.cov2.s-seizure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s)
72 2021-04-12 tingling Irregular heartbeat, thinghlin on left leg and headlight feeling.
72 2021-04-13 weakness Low grade fever for 24 hours; Achy joints 3 days; lack of energy 5 days; gastrointestinal symptons, ... Read more
Low grade fever for 24 hours; Achy joints 3 days; lack of energy 5 days; gastrointestinal symptons, first 24 hrs extreme diarrhea & gas; 2 days later after eating extreme diarrhea gas & severe stomach cramps lasting 12 hours; 5 days later loose stools and slight nausea with some gas after eating meal. This is day 5 feeling better but not 100% yet. Additional Information: April 14, 2021 At 5 pm on day 5 again started watery diarrhea and stomach cramps. Bowel movement was water just like a colon prep clean out for colonoscopy. Day 6 diarrhea stopped but stomach still queasy and mild cramping. This is day 8 and still stomach issues after eating. Queasy and mild cramping.
72 2021-04-15 muscle twitching, weakness Debilitating headaches, nausea,blurred vision, weakness, palpitations, twitching on lower leg.
72 2021-04-16 pain in extremity Left leg pain
72 2021-04-21 feeling cold DIZZY; FELT COLD; DRY HEAVES; COUGHING; SEVERE CHILLS; TIREDNESS; FEVER; HEADACHE; QUEASY/NAUSEA; FE... Read more
DIZZY; FELT COLD; DRY HEAVES; COUGHING; SEVERE CHILLS; TIREDNESS; FEVER; HEADACHE; QUEASY/NAUSEA; FELT LIKE IN FOG; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included furosemide for blood pressure, spironolactone for blood pressure, and metoprolol for drug used for unknown indication. On APR-2021, the subject experienced felt like in fog. On 07-APR-2021, the subject experienced dry heaves. On 07-APR-2021, the subject experienced coughing. On 07-APR-2021, the subject experienced severe chills. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced queasy/nausea. Treatment medications included: ibuprofen. On 08-APR-2021, the subject experienced dizzy. On 08-APR-2021, the subject experienced felt cold. On 08-APR-2021, the subject experienced headache. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coughing, tiredness, and fever on 08-APR-2021, and headache on 11-APR-2021, had not recovered from severe chills, dizzy, queasy/nausea, and dry heaves, and the outcome of felt cold and felt like in fog was not reported. This report was non-serious.
72 2021-04-21 pain in extremity, burning sensation ITCHY RASH; SWELLING ON FACE; SWELLING ON LEGS; BURNING ON FACE ARM AND LEGS; SORE ARM; This spontan... Read more
ITCHY RASH; SWELLING ON FACE; SWELLING ON LEGS; BURNING ON FACE ARM AND LEGS; SORE ARM; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, penicillin allergy, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAR-2021, the subject experienced sore arm. On 13-MAR-2021, the subject experienced itchy rash. On 13-MAR-2021, the subject experienced swelling on face. On 13-MAR-2021, the subject experienced swelling on legs. On 13-MAR-2021, the subject experienced burning on face arm and legs. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning on face arm and legs, and sore arm, and had not recovered from itchy rash, swelling on face, and swelling on legs. This report was non-serious.
72 2021-04-22 weakness FAST HEART RATE; BLOOD CLOT IN BOTH LUNGS; ACHY; LOW ENERGY; VERY WEAK; HEADACHE; FEVER; This sponta... Read more
FAST HEART RATE; BLOOD CLOT IN BOTH LUNGS; ACHY; LOW ENERGY; VERY WEAK; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on left arm on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included pregabalin(Lyrica) for fibromyalgia and bad back. The patient reported pregabalin makes her gait off. On 13-MAR-2021, the patient felt okay. On 14-MAR-2021, the patient experienced achy, low energy, very weak, headache, fever of 100 degrees fahrenheit. Laboratory data included: Body temperature (NR: not provided) 100 F. On 13-APR-2021, she had wellness visit. The patient had a fast heart rate. Laboratory data included: Heart rate (NR: not provided) 144 (units unspecified). So immediately her electrocardiogram was taken and she was hospitalized for 2 days in emergency room by ambulance and started running tests. The patient had a computer tomography with dye contrast and it showed blood clots in both lungs. She had many tests, echocardiogram and X-rays. Treatment medications (dates unspecified) included: continuous oxygen via nasal prong (3.2 litre down to 2 litre), warfarin sodium(Coumadin), blood, whole, and rivaroxaban(Xarelto). The patient stated once she had rivaroxaban she felt "free". Currently also had 2 intravenous and taking blood regular. She was also on physical therapy. The therapist came in and made her walk across her room twice according to therapist she did not need oxygen. The patient currently had 2 IV's and taking blood regular. The patient will be discharged with or without the oxygen. The patient has machine on her chest with all kinds of wires. She don't know about her oxygen saturation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, low energy, very weak, headache, and fever on 15-MAR-2021, had not recovered from fast heart rate, and the outcome of blood clot in both lungs was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).; Sender's Comments: V0: This is a 72 year old female, unspecified ethnicity, who experienced tachycardia and was noted to have blood clots in both lungs 32 days (around 1 month) after receiving the COVID-19 vaccine ad26.cov2.s on the left arm. Patient had Fibromyalgia and is maintained on Pregabalin (Lyrica). Patient's height and weight were not reported as well as history of smoking, allergies or drug abuse. One day after receiving the vaccine, the patient experienced fever, headache, weakness and pain, which resolved. During a wellness visit after a month from the vaccine, tachycardia was noted and an EKG was done. Patient was immediately brought to the ER, where the CT Scan (with contrast) showed blood clots in both lungs (detailed result not reported). Other tests done were also not reported. Patient was subsequently admitted in the hospital and was discharged after 2 days. The information provided is insufficient to show that the vaccine is causing the event; hence, this is assessed as indeterminate per WHO causality classification of adverse event following immunization. Additional information requested.
72 2021-04-22 slurring, coordination abnormal Pt in previously good health received J&J vaccine 04/09 and felt well until 04/21 when she developed... Read more
Pt in previously good health received J&J vaccine 04/09 and felt well until 04/21 when she developed lower extremity weakness and incoordination which became progressively worse and was accompanied by slurred speech on the afternoon of 04/22. The pt's husband helped her into bed and she apparently died during the night of 04/22-04/23.
72 2021-04-22 pain in extremity ~36 hours after vaccine had expected reaction (site reaction, pain, fatigue, fever). One week later... Read more
~36 hours after vaccine had expected reaction (site reaction, pain, fatigue, fever). One week later experienced repeated site inflammation and pain; new muscle pain across back, and sore, tender to the touch skin around breast and up to collar bone, body aches and fatigue. Resolved and arm pain restarted again 1 week later(4/22/21) (took 2000 mg of Tylenol without effect). when speaking with patient on 4/23/21 arm pain currently the only symptom.
72 2021-04-23 weakness ACHY; SLIGHT HEADACHE; SHOULDER PAIN AT INJECTION SITE; WEAK; This spontaneous report received from ... Read more
ACHY; SLIGHT HEADACHE; SHOULDER PAIN AT INJECTION SITE; WEAK; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced achy. On 11-MAR-2021, the subject experienced slight headache. On 11-MAR-2021, the subject experienced shoulder pain at injection site. On 11-MAR-2021, the subject experienced weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy, slight headache, shoulder pain at injection site, and weak. This report was non-serious.
72 2021-04-23 facial paralysis, mild one side paralysis, inability to speak At unspecified date the patient's nephew noticed acute onset change in the patient's mental status. ... Read more
At unspecified date the patient's nephew noticed acute onset change in the patient's mental status. Upon arrival to unspecified hospital by EMS she was aphasic with right facial droop, right gaze preference, right sided weakness. CT and CTA showed Intraparenchymal hemorrhage with 3mm midline shift as well as superior sagittal dural sinus thrombus in the anterior 3rd. Repeat NCHCT showed bilateral parenchymal hemorrhages.
72 2021-04-25 weakness Pt called the pharmacy on 4/26/2021 stating that since approximately 4/16/2021 (roughly 10 days afte... Read more
Pt called the pharmacy on 4/26/2021 stating that since approximately 4/16/2021 (roughly 10 days after receiving the Janssen Vaccine) she began noticing that she felt tired and fatigued and that she didn't have the normal 'energy' that she was used to. After that time she has noticed a worsening of the fatigue and 'tiredness' to the point that she can no longer perform normal activities. She states that she is normally very active and enjoys activities like cutting the grass and other outdoor chores. But for the last 10 days or so she has been unable to do those things and finds herself falling back asleep during the day. She says this overwhelming feeling of tiredness seems to be getting worse. I suggested she visit her doctor for bloodwork and she said she would do so.
72 2021-04-29 feeling hot, unresponsive to stimuli pt reported feeling hot and lightheaded - 3-5 minutes later, she became unresponsive - I administere... Read more
pt reported feeling hot and lightheaded - 3-5 minutes later, she became unresponsive - I administered one dose of epinephrine, she came to about 3 seconds later, and stayed stable until the EMTs arrived.
72 2021-04-30 myelitis transverse TRANSVERSE MYELITIS; This spontaneous report received from a patient concerned a 72 year old female.... Read more
TRANSVERSE MYELITIS; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced transverse myelitis, a post-infectious or post-vaccine autoimmune phenomenon, in which the body's immune system mistakenly attacks the body's own tissue while responding to the infection. The patient was hospitalized (date unspecified) and the duration of hospitalization was not reported. She was still in need of medical treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from transverse myelitis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210450559-COVID-19 VACCINE AD26.COV2.S-transverse myelitis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
72 2021-05-03 weakness Patient is a 73 y.o. female who presents today with multiple complaints worsening shortness of breat... Read more
Patient is a 73 y.o. female who presents today with multiple complaints worsening shortness of breath, cough, weakness, headache, nausea, and diarrhea. Symptoms began with a cough 3 days prior. She went to dialysis on her usual time. Sent to ER to be evaluated due to cough. Positive COVID-19 4/27. Other family members positive. Patient became progressively more weak, short of breath that she was unable to go to dialysis today. She has had poor intake with intractable nausea and diarrhea. Audible gurgling. In ER, potassium elevated and chest x-ray with congestion consistent with overload. Nephrology intending on dialysis today while inpatient. Due to poor respiratory status now requiring oxygen typically only at night. Decadron added. Not a candidate for remdesivir.
72 2021-05-09 migraine Mild nausea ongoing, migraine, exhaustion ongoing, off balance mentally and physically, mild vertigo... Read more
Mild nausea ongoing, migraine, exhaustion ongoing, off balance mentally and physically, mild vertigo intermittent, low back pain intermittent, both mild and severe,
72 2021-05-09 pain in extremity BOTH ARMS HURT IN THE SHOULDERS; This spontaneous report received from a patient concerned a 72 year... Read more
BOTH ARMS HURT IN THE SHOULDERS; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced both arms hurt in the shoulders. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of both arms hurt in the shoulders was not reported. This report was non-serious.
72 2021-05-13 speech disorder, weakness, facial paralysis Client during TC, expressed through the telephone Spanish Interpreter, received the J & J COVID 19 v... Read more
Client during TC, expressed through the telephone Spanish Interpreter, received the J & J COVID 19 vaccine, in left arm, on 3/14/2021. After receiving vaccine had slight soreness at site, and on 3/27/2021 started having left sided facial droopiness, difficulty swallowing, talking, fatigue, SOB and weakness, around 10:00 am. Per Client, children called 911, and was transported to Hospital. Per Client, was treated at hospital and informed by medical personal, that she probably experienced a stroke. Client was not admitted to hospital, sent home the same day, and instructed to follow up with PCP. Per Client, on 3/29/2021 followed up with PCP, and on 5/12/2021 had a MRI procedure and due to fo
72 2021-05-16 tenderness SORENESS UNDER ARM AREA; TENDERNESS UNDER ARM AREA; TIREDNESS; STRESS; This spontaneous report recei... Read more
SORENESS UNDER ARM AREA; TENDERNESS UNDER ARM AREA; TIREDNESS; STRESS; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-MAY-2021 13:20 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced stress. On 11-MAY-2021, the subject experienced soreness under arm area. On 11-MAY-2021, the subject experienced tenderness under arm area. On 11-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness under arm area, tenderness under arm area, stress, and tiredness on MAY-2021. This report was non-serious.
72 2021-05-31 pain in extremity, burning sensation DYING FROM PAIN; FEVER 99-100.8 F AS IF GOT THE SHOT AGAIN; CHILLS AGAIN; SEVERE PAIN IN THE LEFT LE... Read more
DYING FROM PAIN; FEVER 99-100.8 F AS IF GOT THE SHOT AGAIN; CHILLS AGAIN; SEVERE PAIN IN THE LEFT LEG FROM HIP TO KNEE, THE WHOLE LEFT SIDE; FUNCTIONABLE DURING THE DAY BUT NOT AT NIGHT; CAN NOT SLEEP AT NIGHT; BOTH LEGS HURT AT GROIN; CRIES FROM THE SEVER PAIN; INCREASE IN THE BLOOD PRESSURE; DEHYDRATION WHICH MADE HER VERY THIRSTY; FELT BURNING IN THE RIGHT ARM WHILE GETTING THE SHOT; SWOLLEN FACE; SEVER CHILLS; FELT EXHAUSTED; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip implant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood pressure measurement (NR: not provided) increased, COVID-19 virus test (NR: not provided) negative, Hip X-ray (NR: not provided) normal, and Investigation (NR: not provided) Negative. On 31-MAR-2021, the subject experienced increase in the blood pressure. On 31-MAR-2021, the subject experienced dehydration which made her very thirsty. On 31-MAR-2021, the subject experienced felt burning in the right arm while getting the shot. On 31-MAR-2021, the subject experienced swollen face. On 31-MAR-2021, the subject experienced sever chills. On 31-MAR-2021, the subject experienced felt exhausted. On 14-APR-2021, the subject experienced functionable during the day but not at night. On 14-APR-2021, the subject experienced can not sleep at night. On 14-APR-2021, the subject experienced both legs hurt at groin. On 14-APR-2021, the subject experienced cries from the sever pain. On 14-APR-2021, the subject experienced severe pain in the left leg from hip to knee, the whole left side. On 16-MAY-2021, the subject experienced fever 99-100.8 f as if got the shot again. On 16-MAY-2021, the subject experienced chills again. On an unspecified date, the subject experienced dying from pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increase in the blood pressure, and dehydration which made her very thirsty on 05-APR-2021, felt burning in the right arm while getting the shot on 2021, swollen face, sever chills, and felt exhausted on 14-APR-2021, and fever 99-100.8 f as if got the shot again, and chills again on 21-MAY-2021, had not recovered from severe pain in the left leg from hip to knee, the whole left side, functionable during the day but not at night, can not sleep at night, and cries from the sever pain, and the outcome of both legs hurt at groin and dying from pain was not reported. This report was non-serious.
72 2021-06-08 hot flush INCREASED BLOOD PRESSURE; HOT FLASHES; SLEEPING ALL THE TIME; HIVES; CHILLS; FATIGUE/ EXTREMELY TIRE... Read more
INCREASED BLOOD PRESSURE; HOT FLASHES; SLEEPING ALL THE TIME; HIVES; CHILLS; FATIGUE/ EXTREMELY TIRED; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid cancer, previous gallbladder surgery, and tumor removal surgery, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included patient had allergy to steroids and zinc. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, cetirizine hydrochloride, pethidine hydrochloride, ibuprofen, morphine, and ketorolac tromethamine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: D42A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide, and losartan. On 2021, Laboratory data included: Blood pressure (NR: not provided) 150/90 (unit not reported). On 27-MAY-2021, the subject experienced increased blood pressure. On 27-MAY-2021, the subject experienced hot flashes. On 27-MAY-2021, the subject experienced sleeping all the time. On 27-MAY-2021, the subject experienced hives. On 27-MAY-2021, the subject experienced chills. On 27-MAY-2021, the subject experienced fatigue/ extremely tired. On 27-MAY-2021, the subject experienced headache. On 27-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Highest temperature 101 and normal temperature 96.7. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol, acetylsalicylic acid, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever on 2021, was recovering from chills, had not recovered from hives, and fatigue/ extremely tired, and the outcome of increased blood pressure, hot flashes and sleeping all the time was not reported. This report was non-serious.
72 2021-06-13 pain in extremity I have had Rheumatoid for about 10 years and I am 73 yrs old. I have been on Methatrextrate and En... Read more
I have had Rheumatoid for about 10 years and I am 73 yrs old. I have been on Methatrextrate and Enbrel 50 mg once a week for about 8 yrs. I was I guess what the doctors call in remission until I had a Johnson and Johnson Covid vaccine on April 2, 2021. Guess I should start with the side effects from the vaccine...2 days after receiving it I was very fatigued for 2 days then on day 7 my collar bone started to hurt, thinking I had slept wrong I just ignored it. On day 8 my lymph nodes under the arm that I had the shot started to feel swollen. After checking I did not feel any lumps but if it was still there the next day I was going to call my doctor. My niece and 2 of her friends were discussing it and all three had the same reaction (all had Modena) I started reading more on line regarding this and saw that it was just a side effect. Well 10 days after shot my hands and knees started to hurt by one month the pain was terrible. After going to both my primary doctor on May 24th and my RA doctor a week later and having had all the blood work done. My RA doctor stated all my bloodwork was fine and she believes that the Covid vaccine was causing the Enbrel not to preform like it should. All I could find in was one regarding a man with RA taking Enbrel and after having a Covid vaccine having the same issue. My doctor told me to try the Enbrel for another 2 weeks and if not better she no found one lady that takes infusions for her Rheumatoid and had flare ups also after her Covid Vaccination. There is also a man in his 50?s that went there the same thing. He was on Enbrel and had to end up with steroid shots. would try me on Humira. Well I read that didn't work either on the man I mention below. I am hesitant to change from Enbrel to Humira as I have had great success with Enbrel. Also I have Can you shed some light on why this is happening and have you had anyone else report this?
72 2021-06-15 muscle spasms SWOLLEN KNEES; LOOSE JOINTS; CHARLEY HORSE; HIGH FEVER (3 DEGREES OVER NORMAL); SEVERE FATIGUE; MUSC... Read more
SWOLLEN KNEES; LOOSE JOINTS; CHARLEY HORSE; HIGH FEVER (3 DEGREES OVER NORMAL); SEVERE FATIGUE; MUSCLE SPASMS; SEVERE MUSCLE CRAMPS; DIFFICULTY WALKING/BARELY MOBILE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 180898L (or a 2 for last digit)) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced muscle spasms. On 06-APR-2021, the subject experienced severe muscle cramps. On 06-APR-2021, the subject experienced difficulty walking/barely mobile. On 06-APR-2021, the subject experienced charley horse. On 06-APR-2021, the subject experienced high fever (3 degrees over normal). On 06-APR-2021, the subject experienced severe fatigue. On 12-MAY-2021, the subject experienced swollen knees. On 12-MAY-2021, the subject experienced loose joints. On 04-JUN-2021, Laboratory data included: Blood test (NR: not provided) No blood clots detected., and X-ray (NR: not provided) No diagnosis. The action taken with covid-19 vaccine was not applicable. The patient recovered from high fever (3 degrees over normal), and severe fatigue on 14-APR-2021, and had not recovered from muscle spasms, severe muscle cramps, difficulty walking/barely mobile, swollen knees, loose joints, and charley horse. This report was non-serious.
72 2021-06-17 limb paralysis lost feelings in left arm (2 finger)
72 2021-07-12 weakness BLOOD PRESSURE HIGH; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DIZZINESS; HEADACHES; NAUSEA; WEAKNESS... Read more
BLOOD PRESSURE HIGH; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DIZZINESS; HEADACHES; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a 72 year old female. Initial information was processed along with additional information received on 04-JUL-2021, 08-JUL-2021 and 09-JUL-2021. The patient's weight was 64.86 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: unknown) dose was not reported, 1 total administered to upper left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, (5 days after vaccination) the patient had a strong reaction to the vaccine and experienced headaches, dizziness, nausea, and weakness which persisted for several weeks. On an unspecified date, the patient experienced high blood pressure and started using losartan, and metoprolol from 30-MAR-2021 as treatment. On 22-JUN-2021, the patient's physician got tested her for the spike protein immunoglobulin G (IgG Antibody) test and its results came negative (confirmed immunological vaccine failure). The patient wanted to know whether it was okay to get another vaccine as a booster dose to boost her immunity because she felt if she did not do that, she would be at risk of catching a virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headaches, nausea, and weakness, had not recovered from blood pressure high, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000185416. The suspected product quality complaint has been confirmed to be not voided (meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0 - 20210710887-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
72 2021-07-13 numbness and pain in extremities Same night of vaccine had the most intense bout of the periperal neuropathy I frequently get from de... Read more
Same night of vaccine had the most intense bout of the periperal neuropathy I frequently get from degenerative disks and pinched nerves I have suffered with for years. It was in both legs and feet and I usually only have one side stabbing me at night after I lay down. It lasted all night long as it usually does but the intensity was hard to deal with. It did stop the next day but really shocked me after receiving the J and J
72 2021-07-20 discomfort Patient developed symptoms of sinus congestion around 07/13/2021. She has pressure that is in her ch... Read more
Patient developed symptoms of sinus congestion around 07/13/2021. She has pressure that is in her cheeks, forehead, and into her ears and gums. Also has had a headache, vomiting, mild cough, loose stools.
72 2021-07-23 tingling BACK PAIN WHICH HAS RADIATED TO THE LEGS; LEGS FEEL LIKE THEY ARE SLEEPING; This spontaneous report ... Read more
BACK PAIN WHICH HAS RADIATED TO THE LEGS; LEGS FEEL LIKE THEY ARE SLEEPING; This spontaneous report received from a consumer concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy, and other pre-existing medical conditions included the patient is not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802012, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced back pain which has radiated to the legs. On 10-MAY-2021, the subject experienced legs feel like they are sleeping. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain which has radiated to the legs, and legs feel like they are sleeping. This report was non-serious.
72 2021-07-26 pain in extremity Pharmacist had administered Janssen Covid Vaccine instead of second Moderna Dose on 07/23/2021 (Fri... Read more
Pharmacist had administered Janssen Covid Vaccine instead of second Moderna Dose on 07/23/2021 (Friday). It was Vaccination error. I, contacted the patient on 07/24/2021 (saturday ) . Patient was fine except light headache and soar arm .
73 2021-03-07 numbness, tingling Tingling/numbness two middle fingers of same arm. Later had rash in same arm.
73 2021-03-08 flushing Anaphylactic reaction-flushing, lump throat, cough onset within 10 minutes. InER 2hrs home on medica... Read more
Anaphylactic reaction-flushing, lump throat, cough onset within 10 minutes. InER 2hrs home on medication solumedrol, benadryl,pepcid, IV fluids
73 2021-03-13 muscle spasms, pain in extremity Shot administered 3/9/2021; side effects started 3/11/2021. Patient states she had chills, muscle p... Read more
Shot administered 3/9/2021; side effects started 3/11/2021. Patient states she had chills, muscle pain/spasms. Mostly in her legs. Her feet still hurt and she states her walking ability has declined. 3/14/2021 she states she has had improvement consistently, but is still feeling her walking ability is back to where it was.
73 2021-03-23 weakness Stated that 45 min after vaccine when walking to car, began having SOB, felt like she was breathing ... Read more
Stated that 45 min after vaccine when walking to car, began having SOB, felt like she was breathing through cotton and then sand. Increased her prednisone to 20 mg per day. Day 3-4 became dizzy, weak, developed a rash with itching. SOB continued Day 8 SOB is getting better and weaning down to 8 mg prednisone
73 2021-03-26 numbness Pain in chest and neck. Headache with slight feeling of numbness on left side
73 2021-03-30 numbness and pain in extremities 2-3 days after vaccine patient experienced lightheadedness 18 days after the vaccine patient experie... Read more
2-3 days after vaccine patient experienced lightheadedness 18 days after the vaccine patient experienced muscle aches 19 days after patient experienced neuropathy of hands and feet
73 2021-03-31 pain in extremity My arm started hurting about a week and a half after shot and has not stopped. It is not quite as ex... Read more
My arm started hurting about a week and a half after shot and has not stopped. It is not quite as excruciating as it first was but , it still hurts and I have limited movement without pain . Has been like this for 2 weeks now.
73 2021-04-09 tension headache, feeling of body temperature change All my teeth began to ache and progressively get worse to the point I wanted to pull the out. At th... Read more
All my teeth began to ache and progressively get worse to the point I wanted to pull the out. At the same time it felt like my head (in notch immediately forward of middle of ear to ear) was in a tightening vise. Then I got hot and cold but not severely. Same for dizziness, very mild. I was nasusseous and not able to eat. I had random muscles pains , none lasting more than a few minutes in any one place. Odd thing was that I felt no discomfort at sight of injection. Next day I felt just as bad but at 8:30pm I felt like throwing up (after having 2 teaspons of vegetarian vegetable soup). However, I only had dry heaves. I live by myself and started to get scared. I called my daughter and took a Tylenol at 9pm. Within 10 minutes the feeling of a vise and my aching teeth felt significantly better. but stil very fatigued. Next day, today, I feel much better but still a little foggy headed. I can eat. I can function normally, thank heavens. If I had to take another shot now, I wouldn't. Not even sure I'll take a booster when it comes out . It was very scarey.
73 2021-04-12 weakness, numbness Initially had stroke-like symptoms on left side, now resolved. Continues to have extreme weakness an... Read more
Initially had stroke-like symptoms on left side, now resolved. Continues to have extreme weakness and SOA with any exertion.
73 2021-04-13 weakness Patient had the vaccine on March 26, 2021, she started having reactions on March 28th. She states st... Read more
Patient had the vaccine on March 26, 2021, she started having reactions on March 28th. She states started out with chills and fever and progressed into allergy like symptoms and gradually got worse. She has pain from her neck to her toes. Loss of appetite and generalized weakness causing it hard for her to ambulate.
73 2021-04-13 pain in extremity Patient called clinic 4/14/2021 stating the day after she received the vaccine she had chills, fatig... Read more
Patient called clinic 4/14/2021 stating the day after she received the vaccine she had chills, fatigue, extreme pain, pain in the lower back all the way to feet, and discomfort in hands and feet.
73 2021-04-13 tingling, burning sensation, tremor 04/07 evening uncontrollably shaking tingling headache nausea Treated at ER released 3:00 am 04/0... Read more
04/07 evening uncontrollably shaking tingling headache nausea Treated at ER released 3:00 am 04/08. Headaches tingling all day advised to take Tylenol. Advil 04/09. 12:00 am. Face burning mouth throat body tingling prickly heart pain trouble breathing. 2:00 went to ER. Admitted for observation. Given blood thinner copious medications Released 2:00 pm 04/09.
73 2021-04-13 tingling, feeling of body temperature change NECK AND JAW ACHING; LEFT ARM ACHE; HEADACHE; DIARRHEA; FEELING HOT AND COLD FEVER; TINGLING FINGERS... Read more
NECK AND JAW ACHING; LEFT ARM ACHE; HEADACHE; DIARRHEA; FEELING HOT AND COLD FEVER; TINGLING FINGERS; JOINT ACHES; CHILLS; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 175 pounds, and height was 60 inches. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no know allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced feeling hot and cold fever. On 07-APR-2021, the subject experienced tingling fingers. On 07-APR-2021, the subject experienced joint aches. On 07-APR-2021, the subject experienced chills. On 07-APR-2021 17:00, the subject experienced left arm ache. On 07-APR-2021 17:00, the subject experienced headache. On 07-APR-2021 21:00, the subject experienced neck and jaw aching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, neck and jaw aching, and tingling fingers on 08-APR-2021, was recovering from left arm ache, and had not recovered from headache, joint aches, chills, and feeling hot and cold fever. This report was non-serious.
73 2021-04-14 facial pain Constant daily headaches since I got the vaccine worse at night and early morning waking up with ter... Read more
Constant daily headaches since I got the vaccine worse at night and early morning waking up with terrible headache. And itchy blotch on my chest 24 hrs after the vaccine shot. Nausea on and off and pressure in my sinuses pain also down side of my face and nose ,pain while I was sleeping. My headaches have been Constant all since I got this vaccine , pain and pressure in my face.
73 2021-04-15 pain in extremity SORE ARM; RASH ON BACK AND BODY; MORE ITCHY AT THE FRONT AND BACK; LITTLE PIMPLE SPOTS; SCRATCHING/S... Read more
SORE ARM; RASH ON BACK AND BODY; MORE ITCHY AT THE FRONT AND BACK; LITTLE PIMPLE SPOTS; SCRATCHING/SCRATCH CHEST AREA; SHOULDER AREA SCABBED; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included polymyalgia rheumatica, non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies, no drug abuse/illicit drug use. The patient was previously treated with ibuprofen for pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced little pimple spots. On 2021, the subject experienced scratching. On 2021, the subject experienced shoulder area scabbed. On JAN-2021, Laboratory data included: CT scan (NR: not provided) Spot on lung on CT scan, result not reported., and MRI (NR: not provided) Not reported. On MAR-2021, the subject experienced more itchy at the front and back. On MAR-2021, the subject experienced rash on back and body. On 24-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 26-MAR-2021, had not recovered from rash on back and body, more itchy at the front and back, and little pimple spots, and the outcome of scratching and shoulder area scabbed was not reported. This report was non-serious.
73 2021-04-17 weakness Myasthenic Crisis. Hospitalized. Immediately after shot got headache/still have it. Extreme tirednes... Read more
Myasthenic Crisis. Hospitalized. Immediately after shot got headache/still have it. Extreme tiredness day after shot which continued throughput. Got Short of Breath around day 9. Was sent to ER by ambulance from Urgent Care. Was close to being intubated.Was in SICU 7 days, then 2 days regular hospital room. Am still very tired and weak and short of breath with weak diaphragm and will ho back to ER if no improvement.
73 2021-04-17 numbness APRIL 2ND NUMBNESS IN TONGUE, FOLLOWED BY NUMBNESS IN LIP AND PART OF CHEEK, FOLLOWED BY NUMBNESS IN... Read more
APRIL 2ND NUMBNESS IN TONGUE, FOLLOWED BY NUMBNESS IN LIP AND PART OF CHEEK, FOLLOWED BY NUMBNESS IN RIGHT HAND. TRIP TO EMERGENCY ROOM . A BLOOD TEST AND MRI WAS GIVEN AND A STROKE WAS CONFIRMED. I WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION IN EARLY MORNING OF APRIL 3RD. ECHO CARDIOGRAM WAS ADMINISTERED ON APRIL 3. I WAS DISMISSED FROM THE HOSPITAL ON APRIL 3. ON APRIL 5 I PICKED UP A HEART MONITOR TO WEAR FOR ONE MONTH. I HAVE A SCHEDULED APPOINTMENT WITH MY PRIMARY CARE DOCTOR ON FRIDAY, APRIL 16.
73 2021-04-18 pain in extremity Patient experienced severe arm pain beginning within hours after injection, persisted for 2.5 weeks... Read more
Patient experienced severe arm pain beginning within hours after injection, persisted for 2.5 weeks, when she sought treatment at an urgent care facility. Urgent Care facility referred her to ER due to concern of cardiac issues (as patient has history of MI and cardiovascular disease). Went to ER, labwork done, x-rays taken, all cardiac issues ruled out. Severe pain persisted and patient was referred to ortho a week later to rule out injury. Ortho diagnosed with vaccine related injury.
73 2021-04-20 unresponsive to stimuli Patient discovered down and unresponsive with immediate declaration of death. Pronounced dead 4/6/2... Read more
Patient discovered down and unresponsive with immediate declaration of death. Pronounced dead 4/6/2021 11:45 PM
73 2021-04-21 weakness, pain in extremity LOSS OF ENERGY; TIRED; HEADACHE; DIFFICULTY SLEEPING; PAIN IN THE ARM; This spontaneous report recei... Read more
LOSS OF ENERGY; TIRED; HEADACHE; DIFFICULTY SLEEPING; PAIN IN THE ARM; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mango allergy, and shellfish allergy. The patient experienced drug allergy when treated with cefaclor, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine. On 10-APR-2021, the subject experienced difficulty sleeping. On 10-APR-2021, the subject experienced pain in the arm. On 10-APR-2021, the subject experienced tired. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced loss of energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty sleeping on 11-APR-2021, and was recovering from pain in the arm, loss of energy, tired, and headache. This report was non-serious.
73 2021-04-21 bell's palsy BLOODY NOSE; BELL'S PALSY; This spontaneous report received from a patient concerned a 73 year old f... Read more
BLOODY NOSE; BELL'S PALSY; This spontaneous report received from a patient concerned a 73 year old female patient. The patient's height, and weight were not reported. The patient's past medical history included carotid surgery on 12-MAR-2021. The patient received vaccination with JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered to left arm on 02-APR-2021 for prophylactic vaccination. Concomitant medications included clopidogrel bisulfate for blood thinner. The patient reported no other symptoms or side effects after the vaccine. Around 07-APR-2021, patient started getting Bell's palsy and went to the Emergency Room (ER) because she thought she was having a stroke. The patient was diagnosed with Bell's palsy. The patient followed up with primary care provided on 12-APR-2021. Patient's Bell's palsy was not recovered completely but was almost gone. The patient had bloody nose on 13-APR-2021 and went to urgent care. The patient was told not to worry about it and 'it will probably never happen again'. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding from nose, and was recovering from bell's palsy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This 73-year-old female patient experienced medically important Bell's palsy 5 days after receiving JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) intramuscularly to left arm for prophylactic vaccination. The patient's had carotid surgery 21 days prior to the vaccination. Concomitant medications included clopidogrel bisulphate. The patient reported no other symptoms after the vaccination. She started to get Bell's palsy symptoms 5 days post vaccination and visited emergency room. She was diagnosed with Bell's palsy. Details of symptoms, diagnosis, treatment were not reported. She followed up with primary care provider 10 days post vaccination and was seen with Bell's palsy "almost gone". She was recovering from Bell's palsy. The patient experienced non-serious bloody nose the next day and had recovered. Although information is limited, as there is no confirmatory epidemiologic/biologic evidence that vaccinations cause/contribute to the development of Bell's palsy, and the most common causes include viral infection and diabetes, the event is assessed to have an indeterminate causal association to immunization, per WHO causality classification for adverse events following immunization. Company causality for Bell's Palsy is considered not related to JANSSEN COVID-19 VACCINE. Additional information has been requested for further assessment.
73 2021-04-21 pain in extremity HYPERACUSIS; DIZZINESS; SORENESS IN ARM; TIREDNESS; This spontaneous report received from a patient ... Read more
HYPERACUSIS; DIZZINESS; SORENESS IN ARM; TIREDNESS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, tinnitus, nonsmoker, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced hyperacusis. On 07-MAR-2021, the subject experienced dizziness. On 07-MAR-2021, the subject experienced soreness in arm. On 07-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hyperacusis, and dizziness on 07-MAR-2021, soreness in arm on 08-MAR-2021 17:00, and tiredness on 08-MAR-2021. This report was non-serious.
73 2021-04-23 numbness and pain in extremities Neuropathy first of lower leg and feet then of hands and arms.
73 2021-04-23 pain in extremity ARM PAIN; This spontaneous report received from a patient concerned a 73 year old female. The patien... Read more
ARM PAIN; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm pain was not reported. This report was non-serious.
73 2021-04-23 pain in extremity Severe pain in left thigh groin & knee area. Went to ER, confirmed blood clot. Sent home w/blood t... Read more
Severe pain in left thigh groin & knee area. Went to ER, confirmed blood clot. Sent home w/blood thinners - Xarelto
73 2021-04-23 tremor night of 4-7-2021 102 degrees F fever, chills, extreme shaking 4-8-2021 - 4-9-2021 102-103 F fever,... Read more
night of 4-7-2021 102 degrees F fever, chills, extreme shaking 4-8-2021 - 4-9-2021 102-103 F fever, body ache/pain, muscles and bones, especially hips, upper legs, lower back 4-10-2021 afternoon, extreme nausea, took prescription suppository, Promethazine 25 mg sup,, seemed better on 4-11-2021, 4-11-2021 and 4-12-2021 improved, but had bloating and some stomach pain, was on a light diet 4-13-2021 abdominal bloating during the day, then had diarrhea in the evening, then, 4-14-2021 had extreme watery diarrhea, stayed on liquid and then light diet, fatigue for a couple of days, then improved
73 2021-04-26 pain in extremity LEFT SHOULDER PAIN; FELT TIRED; PAIN IN BOTH OF LEGS AND CALF; PAIN AT INJECTION SITE; BRUISE ON HIP... Read more
LEFT SHOULDER PAIN; FELT TIRED; PAIN IN BOTH OF LEGS AND CALF; PAIN AT INJECTION SITE; BRUISE ON HIP; FELL OVER A BOX; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included shoulder surgery, and concurrent conditions included type ii diabetes, lupus, and cholesterol issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced bruise on hip. On APR-2021, the subject experienced fell over a box. On 05-APR-2021, the subject experienced pain in both of legs and calf. On 05-APR-2021, the subject experienced pain at injection site. On 06-APR-2021, the subject experienced left shoulder pain. On 06-APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 06-APR-2021, and felt tired on 07-APR-2021, had not recovered from left shoulder pain, pain in both of legs and calf, and bruise on hip, and the outcome of fell over a box was not reported. This report was non-serious.
73 2021-04-26 tenderness PAIN/EXCRUCIATING; DID NOT SLEEP; SORE TO TOUCH; HARDLY MOVE ARM; This spontaneous report received f... Read more
PAIN/EXCRUCIATING; DID NOT SLEEP; SORE TO TOUCH; HARDLY MOVE ARM; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included bad shoulder, and concurrent conditions included spinal stenosis, and psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain/excruciating. On APR-2021, the subject experienced did not sleep. On APR-2021, the subject experienced sore to touch. On APR-2021, the subject experienced hardly move arm. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain/excruciating, sore to touch, and hardly move arm, and the outcome of did not sleep was not reported. This report was non-serious.
73 2021-05-05 pain in extremity BRUISE AT THE INJECTION SITE; SORE ARM; INJECTION SITE BLEEDING; This spontaneous report received fr... Read more
BRUISE AT THE INJECTION SITE; SORE ARM; INJECTION SITE BLEEDING; This spontaneous report received from a pharmacist concerned a 73 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced injection site bleeding. On an unspecified date, the subject experienced bruise at the injection site, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site bleeding, and the outcome of sore arm and bruise at the injection site was not reported. This report was non-serious.
73 2021-05-06 pain in extremity Thursday late night started have pain in both feet. Friday pain getting worse. Saturday could hard... Read more
Thursday late night started have pain in both feet. Friday pain getting worse. Saturday could hardly walk. Saturday night was getting unbearable. Temperature went from 97.6 to 100.3, then 100.8 and had chills and fever. Extremely rare for me to have chills, etc. Sunday could not walk on feet. Used wheelchair to get to bathroom, etc. Sunday night, I called the urgent care who recommended me to ER. 03/14 admitted to ER. ER did xray of foot to eliminate break. Concluded POSSIBLE cellulitis. Treated with antibiotics. kept overnight for observation. Monday 03/15 pain was severe but could walk to bathroom. Released Monday 03/15 at @ 5:00 pm. Pain subsided after 4 days.
73 2021-05-09 weakness All over body stiffness, muscle aches,hard to walk, couldn't raise arms up, weakness and fatigue. Fi... Read more
All over body stiffness, muscle aches,hard to walk, couldn't raise arms up, weakness and fatigue. First we tried nsaids, then steroids, took various tests including Covid test. I was negative. All this took about 2 months. May 4 was last steroid pill. Nsaids had no good effect. Steroids helped quite a bit, but not totally. The day after the last steroid pill, all the aches, pains, everything came back.
73 2021-05-20 pain in extremity, muscle spasms Injection site, arm muscles are weak, headaches, fatigues, muscle aches and nausea. Intestinal pain... Read more
Injection site, arm muscles are weak, headaches, fatigues, muscle aches and nausea. Intestinal pain, cramps, severe pain in left leg from heel to hip-joint; hands, arms and shoulders joint pain; feet joints, continued sleepiness and drowsiness. Patient has not died yet.
73 2021-06-01 tingling I started having headaches everyday that increased in intensity throughout the day and felt really s... Read more
I started having headaches everyday that increased in intensity throughout the day and felt really sick. It hurt all over, but mainly in the back. I waited to call the doctor because I have seasonal allergies. My head would feel really tingling on the outside, I started experiencing a high pitched screaming sound in my ears and I felt foggy/off, along with memory issues. So after a month, I decided to call my doctor and we had a video call. She ordered an MRI, which hasn't been done yet. I had a CBC count done in the middle of April and it was normal. The headaches are getting better and I'm getting them about once a week versus daily. However, I did have a really bad headache yesterday that I would say was over a 10 on the pain scale, but it's better today.
73 2021-06-09 pain in extremity Patient's arm was sore and continued to hurt to the extent it was difficult to raise above her head.... Read more
Patient's arm was sore and continued to hurt to the extent it was difficult to raise above her head. On 6/7/21, she experienced high blood pressure of >200 systolic and sought care at the ED since she was also having left arm pain. EKG, bloodwork and heart monitoring all indicated no cardiac issues. ED provider recommended acetaminophen for the pain. Blood pressure continued to stay somewhat elevated on 6/8/21 but had returned to baseline by 6/9/21 and patient was feeling better.
73 2021-06-20 weakness UNEXPLAINED SEVERE, CUTTING, HOT, DEEP, INTERNAL-TORNADO LIKE PAIN TO LEFT SHOULDER; EXTREME FATIGUE... Read more
UNEXPLAINED SEVERE, CUTTING, HOT, DEEP, INTERNAL-TORNADO LIKE PAIN TO LEFT SHOULDER; EXTREME FATIGUE AND UNABLE TO CARE FOR MYSELF/3 VERY STRANGE EPISODES WHICH LEFT HER VERY DRAINED; FEEL WEAK; DIZZY/OFF BALANCE; HURT ALL OVER/INCREASE IN NECK AND BACK PAIN; TEETH CHATTERING; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 220 pounds, and height was 67 inches. The patient's past medical history included right shoulder arthroscopy, and weakness, and concurrent conditions included chronic pain homebound patient with scoliosis, bone spurs, spine curvature /abnormalities, abnormal muscles, degenerative disc disease, penicillin allergy, non alcoholic, non smoker, and sick w/ scoliosis at age 16, and other pre-existing medical conditions included the patient had allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included hydromorphone hydrochloride, and oxycodone. On 11-JUN-2021, the subject experienced dizzy/off balance. On 11-JUN-2021, the subject experienced hurt all over/increase in neck and back pain. On 11-JUN-2021, the subject experienced teeth chattering. On 11-JUN-2021, the subject experienced feel weak. On 13-JUN-2021, the subject experienced unexplained severe, cutting, hot, deep, internal-tornado like pain to left shoulder. On 13-JUN-2021, the subject experienced extreme fatigue and unable to care for myself/3 very strange episodes which left her very drained. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from feel weak, teeth chattering, dizzy/off balance, hurt all over/increase in neck and back pain, unexplained severe, cutting, hot, deep, internal-tornado like pain to left shoulder, and extreme fatigue and unable to care for myself/3 very strange episodes which left her very drained. This report was non-serious.
73 2021-06-20 muscle spasms, pain in extremity LEFT HAND STIFFNESS; LEFT HAND SORENESS AND FINGERTIP PAIN; LEFT AND RIGHT ARMPIT PAIN; LEFT HAND AN... Read more
LEFT HAND STIFFNESS; LEFT HAND SORENESS AND FINGERTIP PAIN; LEFT AND RIGHT ARMPIT PAIN; LEFT HAND AND FOOT CRAMPING; INTERMITTENT HEAD ACHES; PAIN BEHIND BOTH EAR; SWELLING IN BOTH ARMPIT, BEHIND BOTH EAR; WATERY EYES; DRIPPY NOSE; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to mold.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 06-SEP-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced watery eyes. On 15-MAY-2021, the subject experienced drippy nose. On 17-MAY-2021, the subject experienced pain behind both ear. On 17-MAY-2021, the subject experienced swelling in both armpit, behind both ear. On 17-MAY-2021, the subject experienced intermittent head aches. On 19-MAY-2021, the subject experienced left hand and foot cramping. On 23-MAY-2021, the subject experienced left and right armpit pain. On 30-MAY-2021, the subject experienced left hand stiffness. On 30-MAY-2021, the subject experienced left hand soreness and fingertip pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from watery eyes, and drippy nose on 16-MAY-2021, and left hand and foot cramping on 30-MAY-2021, and had not recovered from left hand soreness and fingertip pain, left hand stiffness, pain behind both ear, swelling in both armpit, behind both ear, intermittent head aches, and left and right armpit pain. This report was non-serious.
73 2021-06-20 seizure Brain Seizures Stop Dead on movement Extreme Muscular Pain Extreme Bronchitis with green sputum Lame... Read more
Brain Seizures Stop Dead on movement Extreme Muscular Pain Extreme Bronchitis with green sputum Lame leg on left side Red Cell Count was low
73 2021-06-21 difficulty speaking 73 yo female, had reaction 1 hour after Pfizer Covid-19 vaccine 1/21/21- facial swelling, redness an... Read more
73 yo female, had reaction 1 hour after Pfizer Covid-19 vaccine 1/21/21- facial swelling, redness and respiratory symptoms- seen at ER, no epi given. Discussed with allergist, determined that receiving Janssen as an option (with risk involved), advised 1 hour observation in clinic. Pt received Janssen vaccine today. After 30 mins, pt complained of SOB, dry cough and sensation of losing her voice. Pt transported to ED with RN.
73 2021-06-28 weakness The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch nu... Read more
The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced tiredness. On JUN-2021, the subject experienced fatigue. On JUN-2021, the subject experienced lack of energy. On 12-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced soreness in right arm at injection site. On 12-JUN-2021, the subject experienced pain in the muscle in upper arm. On 16-JUN-2021, the subject experienced dark red blood in left eye. On 20-JUN-2021, the subject experienced slight blurred vision in left eye. On 20-JUN-2021, the subject experienced sleeping more than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, dark red blood in left eye, tiredness, slight blurred vision in left eye, fatigue, lack of energy, sleeping more than usual, soreness in right arm at injection site and pain in the muscle in upper arm was not reported. This report was non-serious.
73 2021-06-28 pain in extremity Had normal sore arm after a few days but a month later couldn't get up out the bed without help. Hav... Read more
Had normal sore arm after a few days but a month later couldn't get up out the bed without help. Have no use of her hands she can barely write. Both shoulders are not working so her grandkids have to come pull her up. Hurt all over.
73 2021-07-08 pain in extremity, burning sensation FELT KIND OF YUCKY; BURNED A LITTLE; MALAISE/DON'T FEEL GOOD; SORE ARM; FELT LIKE ALLERGIES; COLD; F... Read more
FELT KIND OF YUCKY; BURNED A LITTLE; MALAISE/DON'T FEEL GOOD; SORE ARM; FELT LIKE ALLERGIES; COLD; FATIGUE/TIRED/FEELING RUN DOWN; SHIVERING/CHILLS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hip and knee pain arthritis, and other pre-existing medical conditions included consumer took an antidepressant and blood pressure medicine and centrum multivitamin when she could afford it. The patient was previously treated with pneumococcal vaccine, influenza vaccine, and varicella zoster vaccine rge (cho) for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included naproxen for hip and left knee arthritis, and paracetamol for to prevent headaches. On 29-MAR-2021, the subject experienced shivering/chills. On 29-MAR-2021, the subject experienced fatigue/tired/feeling run down. On 30-MAR-2021, the subject experienced cold. On 30-MAR-2021, the subject experienced felt like allergies. On an unspecified date, the subject experienced felt kind of yucky, burned a little, malaise/don't feel good, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, felt kind of yucky, malaise/don't feel good, sore arm, shivering/chills, felt like allergies, and fatigue/tired/feeling run down, and the outcome of burned a little was not reported. This report was non-serious.
73 2021-07-11 tingling Tingling pain radiating from left shoulder down to fingers. Painful enough for patient cant sleep on... Read more
Tingling pain radiating from left shoulder down to fingers. Painful enough for patient cant sleep on it. Started 2 weeks post vaccination
73 2021-07-16 weakness KIDNEY STONE; WEAKNESS IN BOTH LEGS, LOWER BACK AND PELVIC AREA; MORE FATIGUE/TIRED; MORE WEAKNESS; ... Read more
KIDNEY STONE; WEAKNESS IN BOTH LEGS, LOWER BACK AND PELVIC AREA; MORE FATIGUE/TIRED; MORE WEAKNESS; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included right hip replacement, and concurrent conditions included hypertension, penicillin allergy, and sulfur allergy, weakness and fatigue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: Unknown) dose was not reported, 1 total, administered on 27-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 2020, Laboratory data included: Arthroscopy (NR: not provided) Not reported. The patient stated that she had been experiencing more weakness and fatigue than usual since Apr-2021 three weeks after taking vaccine. Further, the patient reported that in APR-2021, the pain intensified along with the weakness in both legs, pelvic area, and lower back 2-3 weeks after vaccination. On 20-MAY-2021, she went to emergency room for kidney stone. The patient was referred to pain specialist and stated that she felt about the same and wanted her leg to work. The patient was tired and fatigued. Laboratory data included: CAT scan (NR: not provided) Kidney stone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more fatigue/tired, weakness in both legs, lower back and pelvic area, and more weakness, and the outcome of kidney stone was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210727924-Ccovid-19 vaccine ad26.cov2.s-kidney stone. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
73 2021-07-16 tingling MAGNETIC RESONANCE IMAGING ABNORMAL; RIGHT ARM WEAKNESS; STIFF NECK; HEAVY HEAD FEELING; TINGLING; T... Read more
MAGNETIC RESONANCE IMAGING ABNORMAL; RIGHT ARM WEAKNESS; STIFF NECK; HEAVY HEAD FEELING; TINGLING; This spontaneous report received from a physician concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included white matter changes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced stiff neck. On 25-JUN-2021, the subject experienced heavy head feeling. On 25-JUN-2021, the subject experienced tingling. On 25-JUN-2021, the subject experienced right arm weakness. On 05-JUL-2021, Laboratory data included: CAT scan (NR: not provided) unknown. On an unspecified date, the subject experienced magnetic resonance imaging abnormal. Laboratory data (dates unspecified) included: MRI (NR: not provided) White matter and vasculo ischemic changes, micro angiopathic ischemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiff neck, heavy head feeling, and right arm weakness, and the outcome of tingling and magnetic resonance imaging abnormal was not reported. This report was non-serious.
73 2021-07-20 numbness Total numbness in hand and arm.
74 2021-03-13 tremor severe headache, tremors, nausea, diarrhea, nausea, sleeplessness
74 2021-03-14 pain in extremity Janssen Lot #1805031 Approximately 2 1/2 hours after injection experienced chills for about 45 minut... Read more
Janssen Lot #1805031 Approximately 2 1/2 hours after injection experienced chills for about 45 minutes. Approximately 3 hours later had a much more severe episode of the chills along with leg aches. I used heating pads and took an Advil when I could not stop shivering . Second episode lasted over an hour.
74 2021-03-25 weakness She got the vaccine, was feeling fine, went to church and did her normal things for the rest of the ... Read more
She got the vaccine, was feeling fine, went to church and did her normal things for the rest of the day, and approximately 24 hours after the vaccine around 12:30 to 1:00 and started getting chills. She wrapped up in a blanket and took a nap. Then approximately 1:30 PM she had blurry vision, couldn't see clear, and she felt very, very faint like she was going to faint and was sitting in a chair and continued to sit there for a few minutes. Then she was weak after that, and then a while later she was okay.
74 2021-03-30 pain in extremity Sore muscles through 3/30. Severe joint pain continuing. Knees have been replaced and they hurt li... Read more
Sore muscles through 3/30. Severe joint pain continuing. Knees have been replaced and they hurt like they did 2 wks after surgery. Right shoulder had cortisone shot 2/24/21 and it hurts more than it did before that. fingers hurt to bend, It is now 1 week since the injection
74 2021-04-06 pain in extremity Exactly 2 weeks later, I was experiencing pain and red splotches on my upper back around my left sid... Read more
Exactly 2 weeks later, I was experiencing pain and red splotches on my upper back around my left side, Including my left breast.
74 2021-04-06 tingling Instructed patient to wait 30 minutes due to previous history of allergic reaction of penicillin. ... Read more
Instructed patient to wait 30 minutes due to previous history of allergic reaction of penicillin. Patient waited 30 min period with no apparent symptoms. Pt was asked if she was ok, pt stated she was. Patient was then instructed she could leave. Pt then returned in approximately 15 minutes and stated that when she removed her mask she noticed that her nose and around here eyes were red and possibly swollen. She removed her mask for immunizer and it was noticed that her cheeks nose and lips did appear to be red and possibly swollen. She stated that her nose felt tingly and her mouth and lips felt tight, but did not complain of a swollen tongue. Immunizer administered 50mg of liquid diphenhydramine . Pt also given one dose of Famotidine 40mg. Took blood pressure and found it to be elevated to around 200/90 with pulse rate of 65 bpm. Instructed the patient that we would need to call medics to come check her out. She begged immunizer not to call due to the anxiety it would cause her husband who has , possibly, some issues understanding. Pt was monitored for approximately with epipen on standby for approximately two hours by pharmacist immunizer. Patient began to feel better redness and and puffiness subsided patient went home. Pt returned on 4/7/21 with normal blood pressure and no issues. Pt state BP was high due to fear of going to hospital.
74 2021-04-11 tremor Janssen COVID-19 Vaccine EUA Shakiness, headache, muscle aches, fatigue. Started next morning and la... Read more
Janssen COVID-19 Vaccine EUA Shakiness, headache, muscle aches, fatigue. Started next morning and lasted 1.5 days. Nothing severe.
74 2021-04-12 weakness I received the shot at 440 pm on 3/17 At 11;00 pm the same day i started with extreme headache like... Read more
I received the shot at 440 pm on 3/17 At 11;00 pm the same day i started with extreme headache like migraine, nauseous, terrible joint pain, weakness with sweats. continuing through now 4/13 . When i take a shower so weak and shaky. am using a walker to get around the house. very sleepy. legs weak. I tried to work 4/10 driving for uber 5 hours by the time i got home every muscle and joint was hurting and the headache again . I have taken tylenol for the pain , I have not been able to work except that one day and i shouldn't have then i guess . i thought i was better/ I am in contact with my dr. The office does not know how long these symstoms will last
74 2021-04-12 tremor Fever, chills, shaking, body ache hit all at once. Bed bound for about 30 hours. Took 2 extra streng... Read more
Fever, chills, shaking, body ache hit all at once. Bed bound for about 30 hours. Took 2 extra strength Tylenol about every 4-5 hours for about 24 hours
74 2021-04-13 weakness Ongoing fever for 7+ days, 100.6 F 4/7 onset, weakness, fatigue
74 2021-04-14 discomfort, unresponsive to stimuli Patient woke up at 3am not feeling good and confused. Became increasingly confused and uncomfortabl... Read more
Patient woke up at 3am not feeling good and confused. Became increasingly confused and uncomfortable. Not very responsive to caregivers. Called an ambulance at 7:30am. ER ran tests that showed Sepsis with n o underlying infection. Patient had to be intubated. Admitted to ICU in hospital. Spent 3 days there and 4 days in regular room at hospital. Then transferred to a rehabilitation clinic where she is currently.
74 2021-04-14 pain in extremity 5 pm on Sunday, I started getting pains on my lower leg. Not like an ache. All up and down the insid... Read more
5 pm on Sunday, I started getting pains on my lower leg. Not like an ache. All up and down the inside of the leg (the pain was). There was a pressure point where I found a point where if I pressed it, it was really painful. My skin - the inner leg towards the back - it was really really sensitive. If you touched it lightly it felt painful - not a searing pain. If I massaged it, it would go away but in a few minutes it would come back. I took an aspirin in case of a clot. At this time, I was thinking of deep vein thrombosis. Gradually, it went away. It lasted quite awhile - it lasted between 2 or three hours like this. Even now, the skin isn't sensitive, but I can still press that one point and it hurts. (That pressure point.) I went to the Doctor on the 13th, he sent me to an Ultrasound there wasn't a clot in the leg. That came out fine. When I had the IBS for four months (with a lot of diarrhea). I just found out yesterday that my magnesium was low and they gave me a drip for that. My potassium was a little low also. I had the magnesium drip last night - it was an Hospital ER visit - but it was for bloodwork that had been done yesterday to check me after IBS symptoms.
74 2021-04-15 pain in extremity Mom started feeling ill on Tuesday, April13 with extreme fatigue and a headache. Then on Wednesday,... Read more
Mom started feeling ill on Tuesday, April13 with extreme fatigue and a headache. Then on Wednesday, April 14 she experienced: Headache Dizziness Swelling: Left side of face Swelling: Neck Swelling: Knees and legs (unusual swelling) Chest pain Right arm pain shooting up shoulder left arm pain back pain (unusual/more intense) We went to the ER and they treated her with: pain relief 4 aspirin IV Benadryl
74 2021-04-18 pain in extremity For 2 nights following the immunization, starting the night of the shot, bleeding from the injection... Read more
For 2 nights following the immunization, starting the night of the shot, bleeding from the injection site occurred, overnight. In the morning, her entire arm was covered in blood and her sheets wet. Her husband cleaned her up, and the next day, she did not have any bleeding. But then the second night, again overnight, she bled heavily and woke up with her arm covered in blood and sheets wet with blood. She also experienced leg pain so bad that she couldn't walk. This happened after she had done some leg exercises in which she used a tension band.
74 2021-04-19 weakness, pain in extremity, tremor Pain in right and left leg. Pain started at hip and run down to toes. Pain was not shooting pain but... Read more
Pain in right and left leg. Pain started at hip and run down to toes. Pain was not shooting pain but was a constant pain. On a pain scale of 1-10, pt reports pain was around 20. Pain woke patient up from sleep and was strong enough that patient muscles locked up. Patient began trembling from the pain. Pain lasted about about 24 hours. Pain was so strong that patient could not think. Pain caused patient to become weak and lethargic.
74 2021-04-19 weakness She is a 74-year female with history of morbid obesity, OA on chronic opioids, T2DM, CKD 3, HTN, and... Read more
She is a 74-year female with history of morbid obesity, OA on chronic opioids, T2DM, CKD 3, HTN, and hypothyroidism who presents with 10 days of worsening fatigue and trouble ambulating. She reports that she started feeling unwell about 10 days ago with a sore throat and pain radiated to her left ear. She had trouble swallowing due to the pain and was generally tired, thinking she had strep infection or ear infection. Her sore throat resolved as did her ear pain, however her fatigue worsened and had trouble walking due to weakness. Felt like she had trouble functioning at home, soshe presented to the ED. In the ED, she is hemodynamically stable, satting low 90s on room air. Labs are significant for mild hyponatremia 133 and bump in creatinine 1.84 (previously 1.44). Found to be Covid positive, and CXR with possible right lower lobe infiltrate. Currently, reports feeling tired with poor appetite and body aches though no shortness of breath, chest pain, nausea. She has been eating foods that taste good to her, not following diabetic diet and sugars have stayed appropriate. Denies any sick contacts or leaving the house. Of note had her Covid vaccine (J&J) 3/22 in her house, and does not know where she contracted Covid.
74 2021-04-21 feeling hot WARM FEELING IN THE BELLY; This spontaneous report received from a patient concerned a 74 year old f... Read more
WARM FEELING IN THE BELLY; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood test (hba1c - 6.5%), and concurrent conditions included diabetes, sulfa allergy, cortisone allergy, non-smoker, epinephrine allergy, and dialkylthiolurea allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced warm feeling in the belly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm feeling in the belly on 11-MAR-2021. This report was non-serious.
74 2021-04-22 pain in extremity, discomfort Approx 1 wee after vaccination, I had a full body massage. Light non deep tissue. That evening my ... Read more
Approx 1 wee after vaccination, I had a full body massage. Light non deep tissue. That evening my legs started to ache. The discomfort persisted and settled in my right knee. I could not bend it and barely walk. I had to miss work one day snd borrow a wheel chair got my remaining work days.
74 2021-04-22 pain in extremity, tingling, numbness, muscle spasms NAUSEA; DIARRHEA; LEG CRAMPS; TINGLING TO THE HANDS, FEET AND THROUGHOUT THE WHOLE BODY; NUMBNESS TO... Read more
NAUSEA; DIARRHEA; LEG CRAMPS; TINGLING TO THE HANDS, FEET AND THROUGHOUT THE WHOLE BODY; NUMBNESS TO THE FINGERS AND TOES; BLURRED VISION; INTERMITTENT HEADACHE; PAIN INSIDE THE RIGHT THIGH; FATIGUE; SORE RIGHT ARM; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, hypothyroidism, milk allergy, tomato allergy, wheat allergy, allergic to weeds, allergic to cat and dog dander, sulfonamide allergy, and tetracycline allergy. The patient experienced drug allergy when treated with epinephrine, and erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sore right arm. On 06-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced tingling to the hands, feet and throughout the whole body. On 12-APR-2021, the subject experienced numbness to the fingers and toes. On 12-APR-2021, the subject experienced blurred vision. On 12-APR-2021, the subject experienced leg cramps. On 12-APR-2021, the subject experienced pain inside the right thigh. On 12-APR-2021, the subject experienced intermittent headache. On 14-APR-2021, the subject experienced diarrhea. On 18-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore right arm, and fatigue on 09-APR-2021, and had not recovered from tingling to the hands, feet and throughout the whole body, numbness to the fingers and toes, intermittent headache, blurred vision, diarrhea, nausea, leg cramps, and pain inside the right thigh. This report was non-serious.
74 2021-04-22 tingling TINGLING IN RIGHT ARM THAT LASTED 15 MINUTES AFTER INJECTION; This spontaneous report received from ... Read more
TINGLING IN RIGHT ARM THAT LASTED 15 MINUTES AFTER INJECTION; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and concurrent conditions included congestive heart failure, diabetes, high blood pressure, allergies to tree, allergies to grass pollen, and left ventricular block. The patient was previously treated with , oral contraceptive nos for drug used for unknown indication; and experienced drug allergy and heart race when treated with hydrocodone bitartrate/paracetamol for drug used for unknown indication, drug allergy when treated with sulfamethoxazole/trimethoprim, povidone-iodine, codeine, erythromycin, and benzylpenicillin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced tingling in right arm that lasted 15 minutes after injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in right arm that lasted 15 minutes after injection on 23-MAR-2021. This report was non-serious.
74 2021-04-26 pain in extremity 74 yr old who exhibited pain during and since covid vaccine administration without prior injury or H... Read more
74 yr old who exhibited pain during and since covid vaccine administration without prior injury or Hx of pain in affected shoulder
74 2021-04-27 feeling hot NOSE BLEED; BODY ACHES; HEADACHE; FATIGUE; NAUSEA; DIZZINESS; WARM FEELING IN THE VEINS OF THE PALMS... Read more
NOSE BLEED; BODY ACHES; HEADACHE; FATIGUE; NAUSEA; DIZZINESS; WARM FEELING IN THE VEINS OF THE PALMS AND FEET; SEVERE CHILLS; This spontaneous report received from the patient concerned a 74 year old mixed race female. The patient's height and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient took no concomitant medications. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of admin not reported, batch number: 1805020 expiry: 25-MAY-2021) dose was not reported,1 total, administered on 09-MAR-2021 to left arm for prophylactic vaccination. On 09-MAR-2021, the patient experienced severe chills at around 21:00, 5 hours post vaccination. On 10-MAR-2021 around 04:30, the patient woke up with a pounding headache, chills, body aches. During day the patient also felt fatigue, nausea, dizziness and a feeling of warmth in the veins of her palms and feet. It was reported that the symptoms disappeared on the morning of 11-MAR-2021, which was 2 days post vaccination. It was reported that about 30 minutes prior to call on reporting day of 25-APR-2021, the patient blew her nose and she said a little bloody clot came out, followed by a nose bleed lasting about 30 minutes. The patient reported that she never got nose bleeds and she had no fever, shortness of breath or chest pain. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient recovered from dizziness, warm feeling in the veins of the palms and feet, body aches, severe chills, fatigue, nausea, and headache on 11-MAR-2021, and nose bleed on 25-APR-2021. This report was non-serious.
74 2021-04-27 pain in extremity The next day after receiving vaccination I experience muscle aches-extreme fatigue-excrushating pain... Read more
The next day after receiving vaccination I experience muscle aches-extreme fatigue-excrushating pain in both legs-head aches-ash on my face
74 2021-04-29 weakness weakness, fatigue, full body stiffness, joint and muscle pain and weakness, stiff neck, difficulty ... Read more
weakness, fatigue, full body stiffness, joint and muscle pain and weakness, stiff neck, difficulty and pain when moving or walking, interrupted sleep due to pain, unable to lift out of a chair with legs only
74 2021-04-30 pain in extremity SHORTNESS OF BREATH; STOMACH CRAMPS; HEADACHE; LEFT ARM SORENESS; TIREDNESS; WORSENING OF FLUTTERING... Read more
SHORTNESS OF BREATH; STOMACH CRAMPS; HEADACHE; LEFT ARM SORENESS; TIREDNESS; WORSENING OF FLUTTERING OF HEART; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight was 266 pounds, and height was 62 inches. The patient's past medical history included concussion in 2019, spinal injuries, anaphylaxis shock after medicine took for bone and swelling, and concurrent conditions included non alcohol user, non-smoker, and reaction to iv dye, fluttering of the heart, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient was previously treated with steroids for swelling. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered one total, on 08-APR-2021 in left arm for prophylactic vaccination. Concomitant medications included roprinolil, atorvastatin, lisinopril , propranolol , salbutamol sulfate(inhaler) as needed, oxybutynin, and paracetamol as needed, all drugs were used for unknown indications. On 09-APR-2021, the patient experienced worsening of fluttering of heart, tiredness. On 10-APR-2021, the patient experienced left arm soreness. On 13-APR-2021, the patient experienced headache. On 17-APR-2021, the patient experienced stomach cramps and recovered on 21-APR-2021. On 19-APR-2021, the patient experienced shortness of breath. It was reported that patient had experienced shortness of breath before shot but not as often. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from stomach cramps on 21-APR-2021, and was recovering from headache, worsening of fluttering of heart, left arm soreness, shortness of breath, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: v0:20210447945: covid-19 vaccine ad26.cov2.s -Worsening of fluttering of heart. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
74 2021-05-03 hot flush Recurrence of "hot flashes" noticed about 2 weeks after injection. "Hot flashes" had subsided after... Read more
Recurrence of "hot flashes" noticed about 2 weeks after injection. "Hot flashes" had subsided after breast cancer treatment with Arimidex; treatment ended in 2018.
74 2021-05-12 numbness Patient complained of numbness in both arms and then chest pain following injection. Ambulance was ... Read more
Patient complained of numbness in both arms and then chest pain following injection. Ambulance was called and treated patient .
74 2021-05-17 feeling hot About 15 minutes after immunization during observation, patient complained of feeling hot all over a... Read more
About 15 minutes after immunization during observation, patient complained of feeling hot all over and somewhat lightheaded. denied chest or other pain, shortness of breath, nausea . initial blood pressure was 210/ >100. Patient assisted to a cot to lay flat. further hx: no prior vaccination problems, but reports only few vaccines in her lifetime. Reports recent change in thyroid supplement few weeks prior . No TSH level since change. Has not been checking BP, but has cuff at home. No known hx hypertension or cardiac disease. hx "white coat HTN" remotely. repeated BP every 5 minutes; 184/92, 72. 172/84, 78. By 30 minutes after vaccine, patient was feeling normal. Was asymptomatic sitting up and then standing . She was discharged with instructions to continue checking her blood pressure at home and if persistently > 140/90, she is to f/u with her medical provider. It was also suggested that she speak with her provider about TSH check 6 weeks after starting her new supplement dose.
74 2021-05-17 muscle spasms, discomfort, feeling cold, hot flush, pain in extremity Sore arm right away and then went to a sore muscle like normal the next day and was sore for three d... Read more
Sore arm right away and then went to a sore muscle like normal the next day and was sore for three days. What happened next, I had gone to ENT for my ear (5th) and he put me on heavy dose of Prednisone (6th). Following Tuesday, I was on Prednisone for ear. I was already really achy by then. On the third day after the Prednisone I fatigue, headaches and neck pain but I didn't have any other pain. I still couldn't hear though. I was on this for almost 4 weeks and from them I started like I was having a hot flash and then I would get cold; sore throat; headaches heavy bones and achy muscles; earaches; fatigue; dizziness like you wouldn't believe. They were cyclical - I'd have them for a couple days and then for about a half a day I'd be a bit better and then it would start up again. The fatigues and dizziness didn't change when the other symptoms seemed to be a bit better. My hearing didn't start to clear until I went to see the 2nd ENT which was a couple of weeks down the road. I do not have the stamina I had before the vaccine - I'm not sleeping well at night and I'm always short of breath at any exertion. It is improving but it's slow. Again, the symptoms I experienced during cyclical times: Cold symptoms, runny nose, sore mouth, ringing in my ears was horrible; dizziness and short of breath - cyclical for three weeks. The Prednisone took away all my cramps and pain in my joints that I had before the vaccine. Currently: My heart feels like it's going 100 miles an hour at night in bed - chest discomfort at night. Legs blue in the shower. The week of the 28th, I was done with the Prednisone and then all the pain came back and more. I can't take an inflammatory - the pain is still there and my usual cramps came back.
74 2021-05-20 feeling cold, hot flush The evening of 5/13/21 pt experienced light headedness, tired, hot/cold flashes; headache, nausea an... Read more
The evening of 5/13/21 pt experienced light headedness, tired, hot/cold flashes; headache, nausea and vomitted once which continued until the evening of 5/15/2021. Has been ok since.
74 2021-05-24 tingling, weakness, feeling hot, flushing 5 min after shot was given: warmth, nausea, dizzy, feeling of passing out, throat closing up, pins ... Read more
5 min after shot was given: warmth, nausea, dizzy, feeling of passing out, throat closing up, pins and needles in face and fingers/hands/forearms, red face and chest, and weakness. Second day, nausea, stomach cramps, dizziness.
74 2021-05-27 pain in extremity Terrible pain affecting all joints; arms, back, shoulders, neck; collar bones, etc Out of breath; f... Read more
Terrible pain affecting all joints; arms, back, shoulders, neck; collar bones, etc Out of breath; fatigue easily; difficulty getting out of chair; walking, doing yard work, interrupted sleep due to pain. this is arthritis , psoritic type with severe aching/pain. Have been referred to rheumatologist. Initial psoriasis flare=up 5 days after injection.
74 2021-06-01 muscle spasms, pain in extremity ELEVATED BP; "SPACEY"; MUSCLE CRAMPS; SORE ARM; EXTREME CHILLS; TIRED; This spontaneous report recei... Read more
ELEVATED BP; "SPACEY"; MUSCLE CRAMPS; SORE ARM; EXTREME CHILLS; TIRED; This spontaneous report received from a patient concerned a 74-year-old white and not-Hispanic or Latino female. The patient's weight was 150 pounds, and height was 61 inches. The patient's concurrent conditions included high blood pressure, allergy to formaldehyde, paint, nail polish, raspberries and pepper. Patient was non-smoker, and non-alcohol user. Patient had breast cancer 15 years ago. Patient had allergy to new carpeting with fire protection coating. Patient did not have any drug abuse or illicit drug use. The patient experienced drug allergy when treated with Tylenol, sulfa drugs, ibuprofen, loratadine, and hydrochlorothiazide/losartan potassium for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 28-MAY-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-MAY-2021, couple hours later vaccination, patient was tired and spacey. At around 10:30 pm, she noted extreme chills and muscle spasms. She could not warm herself up, and kept getting colder and colder. She went ER (emergency room) at 1:30 am because her BP (blood pressure) was high (176/110 mmHg). She left the ER at 5 am it was 150/80 mmHg. At the hospital, they gave her Tylenol, which helped her within an hour. They noted to add some Advil with the Tylenol for relief, and to continue for another 48 hours. Her arm was little a sore. It sometimes cramps in the area about every 8 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacey, and tired on 28-MAY-2021, was recovering from extreme chills, elevated blood pressure, and sore arm, and the outcome of muscle cramps was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210557834-COVID-19 VACCINE AD26.COV2.S-Elevated BP. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE
74 2021-06-13 weakness Experienced pain within minutes in right kidney area and the right and left sides of her head. She t... Read more
Experienced pain within minutes in right kidney area and the right and left sides of her head. She then had a low blood sugar attack. For the following 3 days, she suffered from chills and many low blood sugar attacks. Also upset stomach and diarrhea for a few days, as well as headache and body aches. April 12th, left side of face was puffy and more headaches; continued into April 13th; also some sinus pressure/overall stuffiness June 4th- Vertigo attack; had another back in May Continues to have chills, body aches, and headaches, and tired with low energy
74 2021-06-14 muscle twitching TWITCHING BADLY WHILE LAYING DOWN SLEEPING; NASAL CONGESTION IN THE MORNING; SORE THROAT IN THE MORN... Read more
TWITCHING BADLY WHILE LAYING DOWN SLEEPING; NASAL CONGESTION IN THE MORNING; SORE THROAT IN THE MORNING; LEFT ARM SORENESS WHERE THE VACCINE WAS GIVEN; This spontaneous report received from a consumer concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included has pace maker, and concurrent conditions included alzheimer's disease. The patient experienced drug allergy when treated with morphine, and codeine phosphate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. Concomitant medications included apixaban for blood thinner. On 09-JUN-2021, the subject experienced twitching badly while laying down sleeping. On 09-JUN-2021, the subject experienced nasal congestion in the morning. On 09-JUN-2021, the subject experienced sore throat in the morning. On 09-JUN-2021, the subject experienced left arm soreness where the vaccine was given. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nasal congestion in the morning on 09-JUN-2021, had not recovered from twitching badly while laying down sleeping, and the outcome of sore throat in the morning and left arm soreness where the vaccine was given was not reported. This report was non-serious.
74 2021-06-24 night sweats 3.5 months of prolonged fatigue, headaches, malaise, night sweats, balance issues since Covid vaccin... Read more
3.5 months of prolonged fatigue, headaches, malaise, night sweats, balance issues since Covid vaccine and not improving.
74 2021-07-01 pain in extremity A LOT OF NEUROLOGICAL SYMPTOMS; ARM PAIN; DIZZINESS; FOGGINESS AND FELT REALLY BAD; This spontaneous... Read more
A LOT OF NEUROLOGICAL SYMPTOMS; ARM PAIN; DIZZINESS; FOGGINESS AND FELT REALLY BAD; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid symptoms, and concurrent conditions included fibromyalgia, and various genetic based immune diseases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 01-MAY-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced fogginess and felt really bad. On 08-APR-2021, the subject experienced arm pain. On an unspecified date, the subject experienced a lot of neurological symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm pain, dizziness, fogginess and felt really bad, and a lot of neurological symptoms. This report was non-serious.
74 2021-07-12 pain in extremity Severe pain in right back, right groin, hip and upper leg. Blood clot in right lung. Placed on hepar... Read more
Severe pain in right back, right groin, hip and upper leg. Blood clot in right lung. Placed on heparin (IV medication) by healthcare provider. Transferred to a rehabilitation hospital after being hospitalized for 5 days. Currently has home help by nurse, provided blood thinner. Unable to walk.
74 2021-07-13 muscle spasms, pain in extremity Severe ringing in the ears, ongoing, off and on; muscle aches, bad cramping in calves, feet and toes... Read more
Severe ringing in the ears, ongoing, off and on; muscle aches, bad cramping in calves, feet and toes turned "beet red," very painful. Still sore feet.
74 2021-07-20 pain in extremity End of May, pain started slightly under arm down, it started to spread on side of spine and continue... Read more
End of May, pain started slightly under arm down, it started to spread on side of spine and continued moving under arm and under left practice, Pain is all over , and can even feel it when you breathe
75 2021-03-14 tremor about 5 hours post vaccination, patient started experiencing fever with severe chills and shaking. s... Read more
about 5 hours post vaccination, patient started experiencing fever with severe chills and shaking. she then noticed some splotchy skin on her face, neck, and chest, but there was no itching. she went to a pharmacy near her home to get some benadryl, and the pharmacy there helped her get some benadryl and tylenol and called the paramedics. she was send to the emergency room where they observed her for about 3 hours. her blood pressure was slightly elevated (167/85 per patient) when she arrived, but stabilized. she was sent home around 1:30 am on 3/13. she said the next day, she was extremely tired, but by 3/14, she was her usual active self.
75 2021-03-26 pain in extremity Starting on March 23rd the patient's arm started hurting and she said it feels like something was cr... Read more
Starting on March 23rd the patient's arm started hurting and she said it feels like something was crawling on the inside or outside. It also started feeling numb and it still hurting and feeling numb where she had the shot.
75 2021-04-08 facial paralysis Friday morning after the shot, I noticed I had a sore on the roof of my mouth and on my lip. As the ... Read more
Friday morning after the shot, I noticed I had a sore on the roof of my mouth and on my lip. As the day went on, I had more sore in my mouth. Saturday morning, I had more blisters. On Tuesday, I went to my PCP, he felt like I was turning the corner and thanked me for coming in. Tuesday night, it was bad. I called the pharmacy and they advised calling my doctor. I called the doctor and talked to the nurse but my doctor was out of town. Late Wednesday night, I picked up a script to rinse my mouth with. On Friday, I went to the ED and was diagnosed with Shingles and went to a different doctor for treament and was given medicine. I had pain even when using the ear drops. I stopped the ear drops as directed. I developed paralysis on the right side of my face. I went to an UC you was diagnosed with Ramsey Hunt Syndrome.
75 2021-04-09 bell's palsy Two days past after reciveing the COVID vaccination she devepoled herpes zoster on the right side of... Read more
Two days past after reciveing the COVID vaccination she devepoled herpes zoster on the right side of her mouth and face. They then spread into her right ear canal. She states on the next Friday she awoke with her face drawn. She had developed Bell Palsy.
75 2021-04-11 pain in extremity VOMITING; NECK PAIN; MALAISE; ARM SORENESS/PAIN WAS ACROSS SHOULDER; This spontaneous report receive... Read more
VOMITING; NECK PAIN; MALAISE; ARM SORENESS/PAIN WAS ACROSS SHOULDER; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced neck pain. On 03-APR-2021, the subject experienced malaise. On 03-APR-2021, the subject experienced arm soreness/pain was across shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 04-APR-2021, and malaise on 06-APR-2021, was recovering from arm soreness/pain was across shoulder, and had not recovered from neck pain. This report was non-serious.
75 2021-04-12 inability to speak, mild one side paralysis On 4/7/21 patient administered Janssen vaccine. On 4/8/21 at 7:00 am patient had stroke symptoms and... Read more
On 4/7/21 patient administered Janssen vaccine. On 4/8/21 at 7:00 am patient had stroke symptoms and advised to call 911 after conversation with AARP nurse hotline. Patient had difficult speaking and right side weakness. Transported via ambulance and admitted to hospital until discharge on 4/11 at 1:00 pm. Per patient diagnosis was Hypertensive Crisis, Acute Stroke with High suspicion for cardioembolic stroke.
75 2021-04-12 weakness Extreme fatigue, achiness, in . some arm discomfort, bed for 5 days, pain in back, neck, no appetite... Read more
Extreme fatigue, achiness, in . some arm discomfort, bed for 5 days, pain in back, neck, no appetite, weakness - still not feeling well after 2 weeks - pain in back , neck and shoulders
75 2021-04-12 pain in extremity FEVER, PAIN, SORE ARM, UNABLE TO MOVE.
75 2021-04-14 weakness, pain in extremity Head Pain Chest Pain Severe weakness dizzy leg pain nausea
75 2021-04-15 feeling jittery Patient was admitted due to feeling jittery, with history of seizure, possible non-compliance. Dose ... Read more
Patient was admitted due to feeling jittery, with history of seizure, possible non-compliance. Dose of Keppra increased, chest imaging negative for pneumonia.
75 2021-04-20 pain in extremity STOMACH PAIN; DIARRHEA; VOMITING; SORE ARM; HEADACHE; FATIGUE; BODY ACHE; This spontaneous report re... Read more
STOMACH PAIN; DIARRHEA; VOMITING; SORE ARM; HEADACHE; FATIGUE; BODY ACHE; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included skin reaction to another vaccine in the past (MMR), and concurrent conditions included thyroid, blood pressure, and cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 14:00 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication. On 25-MAR-2021, the subject experienced body ache. On 25-MAR-2021, the subject experienced sore arm. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced fatigue. On 26-MAR-2021, the subject experienced stomach pain. On 26-MAR-2021, the subject experienced diarrhea. On 26-MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and headache, stomach pain, diarrhea, and vomiting on 27-MAR-2021, and sore arm on 08-APR-2021, and the outcome of fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210427911.
75 2021-04-23 tremor SHAKING REALLY BAD; RED NECK; RED SPOT ON NECK; RED SPOT ON CHEST; This spontaneous report received ... Read more
SHAKING REALLY BAD; RED NECK; RED SPOT ON NECK; RED SPOT ON CHEST; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, sulphur allergy, shellfish allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, once a total administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced shaking really bad. On 12-MAR-2021, the subject experienced red neck. On 12-MAR-2021, the subject experienced red spot on neck. On 12-MAR-2021, the subject experienced red spot on chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking really bad, red spot on chest, and red spot on neck, and the outcome of red neck was not reported. This report was non-serious.
75 2021-04-27 seizure Patient presents on 4/21 with sudden onset of severe headache start about 4 days ago and has been p... Read more
Patient presents on 4/21 with sudden onset of severe headache start about 4 days ago and has been persistent since. The pain is all over her head with no particular focal area. CT head: RIGHT PARIETAL CORTICAL INFARCT She had an echo on 4/21/2021 showed normal LV size and function with LVEF 55-60% with no regional wall motion abnormalities. Normal RV structure and function. 1+ AI. No PFO by color doppler. No valvular issues. No history of atrial fibrillation. Patient then had two episodes of seizure on telemetry unit on 4/23/2021 followed by post-ictal phase Patient was discharge 5/26/21 to home with neurology follow-up scheduled in 2-4 weeks. Patient will also receive a Holter for 2 weeks.
75 2021-05-06 nerve pain, muscle spasms, muscle twitching, pain in extremity BLOOD PRESSURE WENT UP TO 192; SPASM; NERVE END HURT/PAIN; MUSCLE TWITCHING; MUSCLE ACHE; PAIN IN LE... Read more
BLOOD PRESSURE WENT UP TO 192; SPASM; NERVE END HURT/PAIN; MUSCLE TWITCHING; MUSCLE ACHE; PAIN IN LEG; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. she was allergic to some unspecified medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04ZA114, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain in leg. On an unspecified date, the subject experienced blood pressure went up to 192, spasm, nerve end hurt/pain, muscle twitching, and muscle ache. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) went up to 192 (unit not provided), 120/70 (normal) (unit not provided). Treatment medications (dates unspecified) included: clonidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure went up to 192, spasm, nerve end hurt/pain, muscle twitching, pain in leg, and muscle ache. This report was non-serious.; Sender's Comments: V0:As per standard protocol, No MAC comment is required for non serious case
75 2021-05-17 tingling Delayed reaction of severe left arm and neck pain beginning 3/30/21. No fever, some tingling in lef... Read more
Delayed reaction of severe left arm and neck pain beginning 3/30/21. No fever, some tingling in left hand. Severe pain lasted 6 days. Still sore 2 months later.
75 2021-06-01 weakness Mother suffering from sarciodosis, however was improiving until she recieved the Johnson and Johnson... Read more
Mother suffering from sarciodosis, however was improiving until she recieved the Johnson and Johnson vaccination. She became very weak, very hard to breath . She was admitted to the Hospital and stayed for about two weeks. Since released from the hospital she never got her strength back and lost more weight. My mother passed away 5/28/2021.
75 2021-06-07 feeling cold Two days after the vaccine I was experiencing extreme tiredness and I was very cold. I felt cold int... Read more
Two days after the vaccine I was experiencing extreme tiredness and I was very cold. I felt cold intermittently I was exhausted every afternoon. The symptoms lasted 3-4 weeks. My blood work and Liver Function tests were not Normal. My Proteins and Liver Enzymes were high. The tiredness came and went. Any amount of Alcohol made me feel like I had a hangover in the morning. It improved gradually. I feel recovered now.
75 2021-06-17 weakness Severe left knee pain at onset 10 days after J+J vaccine; better since onset; affecting daily activi... Read more
Severe left knee pain at onset 10 days after J+J vaccine; better since onset; affecting daily activities. associated signs and symptoms: edema; warmth; stiffness; limitation of movement; weakness; instability; limp; fatigue.
75 2021-06-18 weakness DIZZINESS; PALPITATIONS; DIFFICULTY BREATHING; JOINT PAIN IN BILATERAL SHOLDERS; MUSCLE ACHES; WEAKN... Read more
DIZZINESS; PALPITATIONS; DIFFICULTY BREATHING; JOINT PAIN IN BILATERAL SHOLDERS; MUSCLE ACHES; WEAKNESS; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 123 pounds, and height was 67 inches. The patient's past medical history included laminectomy of l4 & l5, urinary mesh insertion, and removal of urinary mesh, and concurrent conditions included chronic obstructive pulmonary disease, thyroid problems, urinary incontinence, mold allergy, alcohol, and occasional smoking, and other pre-existing medical conditions included the patient has allergy of different plants and prilosec (difficulty breathing & swallowing). The patient had correction of urinary mesh in 2009 and 2010 and did not have history of drug abuse or illicit drug. The patient experienced difficulty breathing and swallowing when treated with omeprazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2020, Laboratory data included: BUN (NR: not provided) UNKNOWN, CBC (NR: not provided) UNKNOWN, Thyroid function test (NR: not provided) UNKNOWN, and WBC (NR: not provided) Elevated. On 29-APR-2021, the subject experienced dizziness. On 29-APR-2021, the subject experienced palpitations. On 29-APR-2021, the subject experienced difficulty breathing. On 29-APR-2021, the subject experienced joint pain in bilateral sholders. On 29-APR-2021, the subject experienced muscle aches. On 29-APR-2021, the subject experienced weakness. On 29-APR-2021, the subject experienced tiredness. On 29-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, palpitations, muscle aches, weakness, tiredness, headache, difficulty breathing and joint pain in bilateral sholders was not reported. This report was non-serious.
75 2021-06-22 weakness On Apr 17, 2021 I had COVID symptoms of cold like symptoms, then a night of chills and coughing, fol... Read more
On Apr 17, 2021 I had COVID symptoms of cold like symptoms, then a night of chills and coughing, followed by aches then weeks of what I thought may be allergies, but not feeling good. I continued to cough, but thought it was attributed to GERD. I wasn't thinking it could be COVID because I had been vaccinated. By May 18, I was having trouble breathing as it was painful to inhale. I thought I might be having a heart attack so went into the emergency room at Hospital. I tested positive in ER. No heart problem. There were also at least 5 blood clots found in my lungs. It felt like what I imagine it would feel like if my ribs were broken and I was trying to take a deep breath. I continued to have difficulty inhaling because of the pain of doing so into the next day (19th) and part of the 20th. I was administered oxygen and pain meds for the first day. I was put on Eliquis, which I am ordered to take for 6 more months. I was released from ICU on the 20th, which appeared to be a quick turnaround. I still have no energy, lack of clarity of thought, and easily out of breath a month later. In the hospital, I had no fever. The only time I think I did was on April 19th when I had the chills and cough.
75 2021-06-29 pain in extremity Weakness in my lower legs- between my knees and my feet. All of a sudden the calves in my legs get s... Read more
Weakness in my lower legs- between my knees and my feet. All of a sudden the calves in my legs get so weak that I have fallen twice. My legs go out from under me. This just happens randomly. I can walk completely normal some days and some days it's not. The severest times is when it's hot outside. Today, I just about fell on my way into a building. I sat down for a few minutes and then it was okay. I have gout in my feet and in my knees but I have never had this weakness attributed with gout. I noticed that both arms - were like a flu-like ache from shoulders to the palms of my hands -that has happened just a couple of time. I see my doctor tomorrow. I go for blood tests and work up in the morning before seeing. him.
75 2021-07-01 burning sensation, tenderness SWELLING OCCURRING FROM TIME TO TIME IN LEFT FOOT/SWELLING OF LEFT FOOT AND RIGHT HAND/FINGER; BRUIS... Read more
SWELLING OCCURRING FROM TIME TO TIME IN LEFT FOOT/SWELLING OF LEFT FOOT AND RIGHT HAND/FINGER; BRUISE; TENDERNESS; BURNING SENSATION; VEINS ARE MORE PUFFED UP DISTENDED AND SWOLLEN; DISCOLORATION OF FOOT AND HAND/ FINGER; LESION/BLISTER ON FOOT; ITCHING ON LEFT FOOT; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 200 pounds, and height was 65 inches. The patient's concurrent conditions included deep vein thrombosis, hypothyroidism, hypertension, penicillin allergy, nickel allergy, wasp sting, peanut allergy, alcohol user, and non smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: 20-MAY-2021) dose was not reported, administered on 11-MAR-2021 15:11 for prophylactic vaccination. Concomitant medications included epinephrine for anaphylaxis, cannabidiol for burning sensation on back of hand/are of foot or hand, acetylsalicylic acid for prevention of deep vein thrombosis, amlodipine for treatment of hypertension, and levothyroxine sodium for treatment of hypothyroidism. On APR-2021, the subject experienced lesion/blister on foot. On APR-2021, the subject experienced itching on left foot. On 17-APR-2021, the subject experienced discoloration of foot and hand/ finger. On an unspecified date, the subject experienced swelling occurring from time to time in left foot/swelling of left foot and right hand/finger, bruise, tenderness, burning sensation, and veins are more puffed up distended and swollen. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, and X-ray (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lesion/blister on foot, had not recovered from itching on left foot, discoloration of foot and hand/ finger, swelling occurring from time to time in left foot/swelling of left foot and right hand/finger, and bruise, and the outcome of tenderness, burning sensation and veins are more puffed up distended and swollen was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
75 2021-07-11 depressed level of consciousness No Immediate effect. Not sure if events are related ! On March 24th 2021, patient received the one J... Read more
No Immediate effect. Not sure if events are related ! On March 24th 2021, patient received the one Janssen # 1805022 Covid vaccine, at home, from a at Home doctor. 1) On May 12th 2021, patient, at home on the vent, began getting tired, she threw up, could barely walk and eventually became totally lethargic. Her oxygen was low and the on hand nurse used the Ambu bag to get her oxygen up to 100, while I called the ENT?s. The ENT?s checked her vitals, and did an EKG. We spoke to the doctor, and although by that time she was acting somewhat ?normal?, the decision was made to take her to hospital. Her oxygen was stabilized and her CO2 at the hospital was 80. She remained in the hospital for four days. 2) On Sunday, July 4th, patient was at home on the ventilator. Approximately 1:30 pm she seemed to become somewhat tired and she dropped her coffee cup.A little later, while eating, she threw up, spilling food and drink on her top. She seemed more tired and needed help changing her top. She sat in her recliner for a while and then she had to go to the bathroom. I took her there in a wheelchair. By the time she was ready to leave the bathroom, she was comatose and I had to lift her, she was dead weight, and place her in the wheelchair. I rolled her to the recliner and lifted her into it. She was then completely unconscious, with a continuously running nose and bubbles and fluid coming from her mouth ! Note: This was exactly same experience we had with her on May 12th 2021, when she was taken to hospital. I increased her breath rate on the Vent from 16 to 20, hoping that would expel CO2. I also increased the oxygen setting on the floor concentrator to 9, her pulse oxy was stable at 90. With the help of my daughter in law and grandson, we repositioned her on the recliner to a more comfortable and accessible position, connected the AMBU bag to the oxygen and slowly applied oxygen through her trach connection. We had also called the emergency, requesting assistance. By slowly squeezing the AMBU bag, I got her oxygen up to 100 ! Note: This Is exactly what we did on May 12 th. The ENT?s arrived shortly and within a few minutes after they arrived, patient started to come out of her comatose condition. The ENT?s checked her vitals,(somewhat normal) did an EKG, and checked her CO2 (45).We spoke to the doctor, and by that time she was acting ?normal? ! The decision was made to keep her at home instead of going to the hospital and an at-home X-ray was ordered in case she aspirated and conducted the following day. This x-ray Did Not show any aspiration !
75 2021-07-20 weakness SUSPECTED CLINICAL VACCINATION FAILURE; PULMONARY THROMBOSIS; MENTAL IMPAIRMENT; COVID-19; COMPUTERI... Read more
SUSPECTED CLINICAL VACCINATION FAILURE; PULMONARY THROMBOSIS; MENTAL IMPAIRMENT; COVID-19; COMPUTERISED TOMOGRAM THORAX ABNORMAL; COUGH; DYSPNOEA; NASOPHARYNGITIS; PAIN; PAINFUL RESPIRATION; ANTICOAGULANT THERAPY; ELECTROCARDIOGRAM; FIBRIN D DIMER; INTENSIVE CARE; SARS-COV-2 TEST POSITIVE; CHILLS; MALAISE; ASTHENIA; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1421473) concerned a 75 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included osteoarthritis, seasonal allergies, and hypothyroidism, and concurrent conditions included mild cold, and Gastroesophageal reflux disease (GERD). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808078, and expiry: UNKNOWN) frequency 1 total, dose was not reported, administered on 03-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included ascorbic acid, colecalciferol, compounded hormones, esomeprazole magnesium, fexofenadine hydrochloride, fluorometholone, fluticasone propionate, thyroid, vitamins nos, and zinc. On 17-APR-2021, patient had COVID symptoms of cold like symptoms, then a night of chills and coughing, followed by aches then weeks of what patient thought may be allergies, but patient was not feeling good. Patient continued to cough, but thought it was attributed to GERD. Patient wasn't thinking it could be COVID because patient had been vaccinated. Patient experienced pulmonary thrombosis, nasopharyngitis, and mental impairment and was hospitalized on unspecified day. By 18-MAY-2021, patient was having trouble breathing as it was painful to inhale. Patient thought patient might be having a heart attack so went into the emergency room at Hospital. Patient was tested positive in emergency room (ER). Patient had no heart problem. There were also at least 5 blood clots found in patient's lungs. Patient felt like what patient imagine it would feel like if patient's ribs were broken and patient was trying to take a deep breath. On 18-MAY-2021, patient experienced suspected clinical vaccination failure. Patient continued to have difficulty inhaling because of the pain of doing so into the next day 19-MAY-2021 and part of the 20-MAY-2021. Patient was administered oxygen and pain meds for the first day. Patient was put on Eliquis, which patient was ordered to take for 6 more months. Patient was released from ICU on the 20-MAY-2021. Patient still have no energy, lack of clarity of thought, and easily out of breath a month later. In the hospital, patient had no fever. Patient thought that the only time patient thought was on 19-APR-2021 when patient had the chills and cough. patient was hospitalized for 3 days. Laboratory data included: Computerised tomogram thorax abnormal (NR: not provided) Not Reported, Electrocardiogram (NR: not provided) Not reported, Fibrin D dimer (NR: not provided) Not reported. On 18-MAY-2021, laboratory test included, SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19, asthenia, chills, computerised tomogram thorax abnormal, cough, dyspnoea, malaise, mental impairment, nasopharyngitis, pain, painful respiration, pulmonary thrombosis, anticoagulant therapy, electrocardiogram, fibrin d dimer, intensive care, sars-cov-2 test positive and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening). This report was associated with product quality complaint: 90000185984. The suspected product quality complaint has been confirmed to be not voided. The reported allegation could not be confirmed, a manufacturing related root cause could not be identified, based on the PQC evaluation/investigation performed. Additional information was received from Consumer Complaint Vigilance Organization on 16-JUL-2021. The following information was updated and incorporated into the case narrative: Investigation result added.; Sender's Comments: V3: In this version following information was updated and incorporated into the case narrative: Investigation result. This updated information does not alter the causality of the previously assessed events. 20210705031-COVID-19 VACCINE AD26.COV2.S -19- Pulmonary Thrombosis, Mental Impairment, Covid-19, Asthenia, Chills, Cough, Dyspnoea, Malaise, Nasopharyngitis, Pain, Painful Respiration. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20210705031-COVID-19 VACCINE AD26.COV2.S -Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20210705031-COVID-19 VACCINE AD26.COV2.S -19- Computerised Tomogram Thorax Abnormal, Anticoagulant Therapy, Electrocardiogram, Fibrin D Dimer, Intensive Care And Sars-Cov-2 Test Positive . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).