chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SEVERE CHILLS; BONE AND JOINT PAIN; FEVER; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 50 year old white female of unknown ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, alcohol use once every 3 months, and non-smoker, and other pre-existing medical conditions included: the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy (mild hives) when treated with omeprazole, and azithromycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, frequency one total administered on right arm on 10-APR-2021 at about 10:30 for prophylactic vaccination. No concomitant medications were reported.  On the day of vaccination after 6 to 8 hours of taking vaccine, the patient experienced severe chills, fever for 12 hours, nausea and fatigue for 4 days, bone and joint pain relieved after 24 hours. On 13-AUG-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: IgG (Immunoglobulin G), Spike protein, semi-quantitative Antibody test (NR: not provided) Negative. On an unspecified date the patient took Tylenol and Advil for fever.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills, bone and joint pain, and fever on 11-APR-2021, and nausea, and fatigue on 14-APR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189749.; Sender's Comments: V0:20210832418- covid-19 vaccine ad26.cov2.s -CONFIRMED IMMUNOLOGICAL VACCINE 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
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hyperhidrosis, Poor quality sleep
Clinical narrative: SWEATING; RESTLESS SLEEP; JOINT ACHES; HEADACHE; This spontaneous report received from a patient via a company representative concerned an adult male. 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: Unknown) dose was not reported, administered on 10-MAY-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 10-MAY-2021, the patient experienced sweating. On 10-MAY-2021, the patient experienced restless sleep. On 10-MAY-2021, the patient experienced joint aches. On 10-MAY-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, restless sleep, joint aches, and headache on 11-MAY-2021. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Back pain, Burning sensation, Fatigue, Feeling hot
Clinical narrative: MORE ACID REFLEX; EXHAUSTION WAS A DIFFERENT TYPE OF TIREDNESS AS IF SHE WAS COMING FROM ILLNESS/ EXTREMELY TIRED; STINGING THROUGH THE KIDNEY, MAINLY THE RIGHT SIDE FOR 1-2 MINUTES; LOWER BACK PAIN; BURNING IN LEGS AND FEET (BURNING, HOTNESS, HEAT IN THE BACK OF LEGS IN THE CALF AREA) AND BOTHERED BY THE ACHENES FEELING, LEGS ARE BURNING HOT WHEN SHE TOUCHES HER LEGS, THEY ARE NOT HOT AND NO PAIN, FEELS THAT THEY ARE HOT (HOT SENSATION); DID NOT SLEEP GOOD WHICH LASTED FOR 3-4 NIGHTS; DRIVING HER CRAZY; IT IS JUST HOW SHE FEELS THAT THEY  ARE HOT( HOT SENSATION); This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included: blood clots in the lungs, and concurrent conditions included: hypertension, stomach ulcer, and acid reflex. 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 10-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced driving her crazy. On AUG-2021, the patient experienced it is just how she feels that they are hot ( hot sensation). On 10-AUG-2021, the patient experienced stinging through the kidney, mainly the right side for 1-2 minutes. On 10-AUG-2021, the patient experienced lower back pain. On 10-AUG-2021, the patient experienced burning in legs and feet (burning, hotness, heat in the back of legs in the calf area) and bothered by the achenes feeling, legs are burning hot when she touches her legs, they are not hot and no pain, feels that they are hot (hot sensation). On 10-AUG-2021, the patient experienced did not sleep good which lasted for 3-4 nights. On 10-AUG-2021, the patient experienced exhaustion was a different type of tiredness as if she was coming from illness/ extremely tired. On an unspecified date, the patient experienced more acid reflex. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not sleep good which lasted for 3-4 nights on 14-AUG-2021, had not recovered from burning in legs and feet (burning, hotness, heat in the back of legs in the calf area) and bothered by the achenes feeling, legs are burning hot when she touches her legs, they are not hot and no pain, feels that they are hot (hot sensation), and the outcome of stinging through the kidney, mainly the right side for 1-2 minutes, lower back pain, exhaustion was a different type of tiredness as if she was coming from illness/ extremely tired, more acid reflex, driving her crazy and it is just how she feels that they are hot( hot sensation) was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Pain, Sleep disorder
Clinical narrative: MORE ACID REFLEX; EXHAUSTION WAS A DIFFERENT TYPE OF TIREDNESS AS IF SHE WAS COMING FROM ILLNESS/ EXTREMELY TIRED; STINGING THROUGH THE KIDNEY, MAINLY THE RIGHT SIDE FOR 1-2 MINUTES; LOWER BACK PAIN; BURNING IN LEGS AND FEET (BURNING, HOTNESS, HEAT IN THE BACK OF LEGS IN THE CALF AREA) AND BOTHERED BY THE ACHENES FEELING, LEGS ARE BURNING HOT WHEN SHE TOUCHES HER LEGS, THEY ARE NOT HOT AND NO PAIN, FEELS THAT THEY ARE HOT (HOT SENSATION); DID NOT SLEEP GOOD WHICH LASTED FOR 3-4 NIGHTS; DRIVING HER CRAZY; IT IS JUST HOW SHE FEELS THAT THEY  ARE HOT( HOT SENSATION); This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included: blood clots in the lungs, and concurrent conditions included: hypertension, stomach ulcer, and acid reflex. 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 10-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced driving her crazy. On AUG-2021, the patient experienced it is just how she feels that they are hot ( hot sensation). On 10-AUG-2021, the patient experienced stinging through the kidney, mainly the right side for 1-2 minutes. On 10-AUG-2021, the patient experienced lower back pain. On 10-AUG-2021, the patient experienced burning in legs and feet (burning, hotness, heat in the back of legs in the calf area) and bothered by the achenes feeling, legs are burning hot when she touches her legs, they are not hot and no pain, feels that they are hot (hot sensation). On 10-AUG-2021, the patient experienced did not sleep good which lasted for 3-4 nights. On 10-AUG-2021, the patient experienced exhaustion was a different type of tiredness as if she was coming from illness/ extremely tired. On an unspecified date, the patient experienced more acid reflex. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not sleep good which lasted for 3-4 nights on 14-AUG-2021, had not recovered from burning in legs and feet (burning, hotness, heat in the back of legs in the calf area) and bothered by the achenes feeling, legs are burning hot when she touches her legs, they are not hot and no pain, feels that they are hot (hot sensation), and the outcome of stinging through the kidney, mainly the right side for 1-2 minutes, lower back pain, exhaustion was a different type of tiredness as if she was coming from illness/ extremely tired, more acid reflex, driving her crazy and it is just how she feels that they are hot( hot sensation) was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Exostosis, Muscle spasms, Vision blurred
Clinical narrative: EYESIGHT WAS TOTALLY BLURRED (BOTH EYES SHE COULD NOT SEE) AND FAILED A DRIVING RENEWAL TEST DUE TO THIS; BOTH LEGS CRAMPED ALL THE TIME; PAINFUL BONE SPUR ON THE LEFT FOOT (SOMETHING HARD ON THE TOP OF HER FOOT AND IT WAS PAINFUL); This spontaneous report received from a patient concerned a 74 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, intramuscular, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-AUG-2021, the patient experienced both legs cramped all the time. On 01-AUG-2021, the patient experienced painful bone spur on the left foot (something hard on the top of her foot and it was painful). On 12-AUG-2021, the patient experienced eyesight was totally blurred (both eyes she could not see) and failed a driving renewal test due to this. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from eyesight was totally blurred (both eyes she could not see) and failed a driving renewal test due to this, and had not recovered from both legs cramped all the time, and painful bone spur on the left foot (something hard on the top of her foot and it was painful). This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: SUSPECTED HEART ATTACK; This spontaneous report received from a company representative concerned a 60 year old male patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was reported that, the patient was fit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknow) with frequency as 1 total for prophylactic vaccination. Dose and therapy start date were not reported. The batch number was not reported. Per Procedure, no follow up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the patient was suspected with heart attack. On an unspecified date, the patient died from suspected heart attack. It was reported that, the patient died within 30 days of receiving vaccine and cause of death was unknown however suspected as heart attack. It was unknown if the autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210832457- covid-19 vaccine ad26.cov2.s-suspected heart attack. 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).; Reported Cause(s) of Death: SUSPECTED HEART ATTACK
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Crying, Feeling of body temperature change, Malaise, Stool analysis
Clinical narrative: AUTOIMMUNE DISORDER; CRYING NON-STOP; FELT VERY COLD AND HOT; NOT BEEN FEELING WELL; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, 1 total, 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, after vaccination, the patient had been crying non-stop, was having bowel issues, was experiencing pain in stomach under ribs, and felt very cold and hot. The patient had generally not been feeling well. It was reported that the patient had an appointment with her doctor and was told that the results of her fecal sample showed that she had an autoimmune disorder. Laboratory data (dates unspecified) included: Stool analysis (NR: not provided) autoimmune disorder (unspecified). It was reported that the patient was feeling progressively unwell during the time of this report and stated that she needed to lie down and could not provide any further information at this time. The patient had a colonoscopy scheduled on Wednesday, 18-AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not been feeling well, and the outcome of crying non-stop, felt very cold and hot and autoimmune disorder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210832464--Autoimmune disorder. 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).
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Feeling abnormal, Thrombosis
Clinical narrative: BLOOD CLOTS; HEART TROUBLE; HE WAS DYING; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. 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: Unknown) dose was not reported, frequency time 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after vaccination the patient had blood clots, (heart trouble) his heart didn't want to work and he was dying. Heart had to be shocked- stimulated heart. It was reported that every couple of days tests was being ran. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots, heart trouble and he was dying was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210832975; Sender's Comments: 20210832472-Covid-19 vaccine ad26.cov2.s-Blood Clots, heart trouble. 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).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 55 year old white Not Hispanic/Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: complex regional pain syndrome (RSD/CRPS), diabetes mellitus, lung disease, Reynold's syndrome, connective tissue disease, mild facial pain syndrome, psoriasis, degenerative disc disease, stenosis, non-alcohol user, smoker, and other pre-existing medical conditions included: the patient did not have any history of drug abuse or illicit drug use except marijuana. The patient was not pregnant at the time of vaccination. The patient has allergy to any medicine ends with zine. The patient experienced drug allergy when treated with morphine, Propofol, oxycontin, injectable Benadryl. 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 14-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 11-AUG-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) negative, SARS-CoV-2 IgM antibody test (NR: not provided) negative, and SARS-CoV-2 IgA antibody test (NR: not provided) negative. The patient wanted an exemption letter to get a booster shot as her doctor recommended (she could not afford to get Covid-19). Her health care professional wanted her to get Pfizer Covid-19 Vaccine. She was frustrated at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189771; Sender's Comments: V0: 20210832576-covid-19 vaccine ad26.cov2.s- confirmed immunological vaccine 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
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: ADVERSE REACTIONS; This spontaneous report received from a patient via a company representative concerned multiple patients.  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: Unknown) 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. No concomitant medications were reported. On an unspecified date, the patient experienced adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: ELEVATED BLOOD PRESSURE; This spontaneous report received from a consumer concerned an adult of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: alopecia. 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 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 APR-2021, the patient experienced elevated blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: JOINT ACHE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No significant medical history. 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 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 12-APR-2021, the patient experienced joint ache. On 12-APR-2021, the patient experienced fever. On 12-APR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint ache, fever, and headache on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210832866.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Atrophy, Body temperature, Joint range of motion decreased
Clinical narrative: ATROPHY OF SHOULDER; BLOOD CLOT; FELT TWINGES IN THE RIGHT SHOULDER; SORENESS IN LEFT ARM; STRENGTH ISSUE WITH THE LEFT ARM AND CAN NOT MAKE A FIST /LOST STRENGTH IN ARM; LEFT SHOULDER STARTED BOTHERING HIM AND NOT HAVING A GOOD RANGE OF MOTION IN THE LEFT SHOULDER AND FEELING IT IN HIS PACK AND BICEPS; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included: bicycle accident, covid-19, lost weight, fever, and tooth absorption, and concurrent conditions included: non-alcohol, and other pre-existing medical conditions included: The patient had no known allergies. There was no drug abuse or illicit drug usage. He only smokes herbs like basil and coriander. He does not smoke cigarettes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included oxycodone/paracetamol.  On JAN-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive.  The patient felt fine and he had a good mobility with his shoulders but on On 15-MAR-2021, a week after vaccination the patient experienced left shoulder started bothering him and not having a good range of motion in the left shoulder and feeling it in his pack and biceps and soreness in left arm. The patient experienced strength issue with the left arm and can not make a fist /lost strength in arm. The patient mentioned that he felt the shot when the vaccine was injected and jumped and the injector asked him whether everything was okay.  The left shoulder issues was not getting better and was not getting worse either.  On 30-MAY-2021, the patient experienced felt twinges in the right shoulder.  On JUN-2021, treatment medications included: apixaban. On 26-JUN-2021, the patient experienced blood clot. On 02-AUG-2021, the patient experienced atrophy of shoulder. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.7 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt twinges in the right shoulder, had not recovered from left shoulder started bothering him and not having a good range of motion in the left shoulder and feeling it in his pack and biceps, strength issue with the left arm and can not make a fist /lost strength in arm, atrophy of shoulder, and soreness in left arm, and the outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210832831 -covid-19 vaccine ad26.cov2.s- blood clots. 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).
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Thrombosis
Clinical narrative: ATROPHY OF SHOULDER; BLOOD CLOT; FELT TWINGES IN THE RIGHT SHOULDER; SORENESS IN LEFT ARM; STRENGTH ISSUE WITH THE LEFT ARM AND CAN NOT MAKE A FIST /LOST STRENGTH IN ARM; LEFT SHOULDER STARTED BOTHERING HIM AND NOT HAVING A GOOD RANGE OF MOTION IN THE LEFT SHOULDER AND FEELING IT IN HIS PACK AND BICEPS; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included: bicycle accident, covid-19, lost weight, fever, and tooth absorption, and concurrent conditions included: non-alcohol, and other pre-existing medical conditions included: The patient had no known allergies. There was no drug abuse or illicit drug usage. He only smokes herbs like basil and coriander. He does not smoke cigarettes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included oxycodone/paracetamol.  On JAN-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive.  The patient felt fine and he had a good mobility with his shoulders but on On 15-MAR-2021, a week after vaccination the patient experienced left shoulder started bothering him and not having a good range of motion in the left shoulder and feeling it in his pack and biceps and soreness in left arm. The patient experienced strength issue with the left arm and can not make a fist /lost strength in arm. The patient mentioned that he felt the shot when the vaccine was injected and jumped and the injector asked him whether everything was okay.  The left shoulder issues was not getting better and was not getting worse either.  On 30-MAY-2021, the patient experienced felt twinges in the right shoulder.  On JUN-2021, treatment medications included: apixaban. On 26-JUN-2021, the patient experienced blood clot. On 02-AUG-2021, the patient experienced atrophy of shoulder. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.7 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt twinges in the right shoulder, had not recovered from left shoulder started bothering him and not having a good range of motion in the left shoulder and feeling it in his pack and biceps, strength issue with the left arm and can not make a fist /lost strength in arm, atrophy of shoulder, and soreness in left arm, and the outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210832831 -covid-19 vaccine ad26.cov2.s- blood clots. 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).
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: THYROID WAS TOTALLY OUT OF RANGE/ IT WAS MESSING UP THE THYROID AND STUFF; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was taking unspecified medication for thyroid. 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced thyroid was totally out of range/ it was messing up the thyroid and stuff. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thyroid was totally out of range/ it was messing up the thyroid and stuff was not reported. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: JOINT ACHES; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned a 47 year old male. 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: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: ibuprofen, and paracetamol. On 11-APR-2021, the patient experienced joint aches. On 11-APR-2021, the patient experienced low grade fever. On 11-APR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint aches, low grade fever, and headache on 11-APR-2021. This report was non-serious. This case, involving the same patient is linked to 20111208304 and 20140118303. This case, from the same reporter is linked to 20210832767.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, HIV test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned an 18 year old male. Initial information was processed along with the additional information received on 17-AUG-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included: cigarette smoker, human immunodeficiency virus (HIV) positive, irritable bowel syndrome (IBS), immunocompromised, and non-alcohol user. The patient had no known allergies nor 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, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, 1 total administered to left deltoid on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-AUG-2021, the patient got tested for the antibody and the results came back as undetected or negative (coded as confirmed immunological vaccine failure). The patient was not sure if the vaccine was working or whether he would need a booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). The case is associated with Product Quality Complaint number 90000189821.; Sender's Comments: V0:20210832913-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine 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
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, General physical health deterioration, Organ failure, SARS-CoV-2 test, Vaccination failure
Clinical narrative: TOTAL ORGAN FAILURE; SUSPECTED COVID-19 INFECTION; CONTINUED TO DIE; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a male of an unspecified age, race and ethnic origin. 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: unknown and expiry: unknown) dose was not reported, 1 total administered in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (after vaccination), the patient developed Covid-19 (suspected clinical vaccination failure) and total organ failure. He was admitted to the hospital. The doctors and nurses could not do anything except comforting him as he continued to die. At the time of this report, the patient was still in the hospital. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from total organ failure, suspected covid-19 infection, and continued to die, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210832919-covid-19 vaccine ad26.cov2.s-total organ failure, suspected covid-19 infection, continued to die (General physical health deterioration). 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). 20210832919-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination 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
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pharyngeal swelling, Pulmonary thrombosis, Rhinorrhoea, Sensory disturbance
Clinical narrative: BLOOD CLOTS IN LUNGS; SHOULDER AND LEFT BREAST LEFT SIDE FEELS PARALYZED/ ARMS AND LEGS FEEL PARALYZED; HANDS, ARMS GOT TINGLING SENSATION; SWOLLEN THROAT; INFECTIOUS STUFF  THAT WAS COMING OUT OF HER MOUTH AND NOSE; This spontaneous report received from a patient concerned a 67 year old female of mixed race half white and half Indian and unknown ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcoholic, and non smoker, and the 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: 1808980, expiry: UNKNOWN) frequency one total, dose was not reported on right arm, administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine besilate (10mg), hydroxyzine hydrochloride (25mg), Tradjenta (5mg), losartan (100mg), and paracetamol (Tylenol).  After three days of vaccination the patient could not breath, went to the hospital (emergency room) on 08-APRIL-2021. A radio dye was injected and the patient was diagnosed with blood clots in her lungs. The patient was coughing blood and had a swollen throat. The patient was treated with Antibiotics and Nasal Spray for infectious stuff that was coming out of her mouth and nose. She was released from the hospital on 08-Apr-2021. She was on Oxygen and cannot breath. The patient experienced shoulder and left breast -left side feels paralyzed / arms and legs feel paralyzed, hands, arms got tingling sensation. Treatment medications (dates unspecified) included: Xarelto (20mg) (rivaroxaban) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in lungs, coughing blood, can't breath, shoulder and left breast -left side feels paralyzed / arms and legs feel paralyzed, swollen throat, and hands, arms got tingling sensation, and the outcome of infectious stuff that was coming out of her mouth and nose was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20210832472.; Sender's Comments: V0: 20210832975- covid-19 vaccine ad26.cov2.s-blood clots in lungs. 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).
Sex: F
Vaccine: COVID19
Symptoms: Coma, Spinal disorder
Clinical narrative: COMA; SOMETHING ABOUT THE SPINE OCCUR; This spontaneous report received from a consumer and concerned a 5 decade old (in her forties) 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 and expiry were unknown) 1 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 went into a coma and something about the spine occurred. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the coma and something about the spine occur was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210833221-Covid-19 vaccine ad26.cov2. s Coma. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: HAD STUFF GOING ON; This spontaneous report received from a consumer concerned a female of unspecified age. 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ergocalciferol. On an unspecified date, the patient experienced had stuff going on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had stuff going on was not reported. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: LYING ALL THE TIME; SEVER HEADACHE (FELT LIKE HEAD IS GOING TO EXPLODE AND BLOOD VESSELS WERE BREAKING IN HEAD); This spontaneous report received from a patient concerned a 61 year old male. 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: 1802072, expiry: 23-AUG-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced lying all the time. On 06-MAR-2021, the patient experienced sever headache (felt like head is going to explode and blood vessels were breaking in head). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lying all the time, and sever headache (felt like head is going to explode and blood vessels were breaking in head) on 09-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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) 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 out of specification product use, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Hypersomnia, Night sweats, Paranasal sinus discomfort
Clinical narrative: FEELS LIKE BURNING UP; WAKING UP IN SWEAT; RUNNY NOSE; SINUS PRESSURE; SNEEZING; WET COUGHING YELLOW MUCUS; SLEPT FOR 18 HOURS STRAIGHT; DRAINAGE WONT STOP; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies, and other pre-existing medical conditions included: Patient takes medication for allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the patient experienced feels like burning up. On 14-JUL-2021, the patient experienced waking up in sweat. On 14-JUL-2021, the patient experienced runny nose. On 14-JUL-2021, the patient experienced sinus pressure. On 14-JUL-2021, the patient experienced sneezing. On 14-JUL-2021, the patient experienced wet coughing yellow mucus. On 14-JUL-2021, the patient experienced slept for 18 hours straight. On 14-JUL-2021, the patient experienced drainage wont stop. On 17-JUL-2021, Laboratory data included: Body temperature (NR: not provided) 97.8 F, 91.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feels like burning up, waking up in sweat, runny nose, sinus pressure, sneezing, slept for 18 hours straight, and drainage wont stop, and the outcome of wet coughing yellow mucus was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Rhinorrhoea, Sneezing, Upper-airway cough syndrome
Clinical narrative: FEELS LIKE BURNING UP; WAKING UP IN SWEAT; RUNNY NOSE; SINUS PRESSURE; SNEEZING; WET COUGHING YELLOW MUCUS; SLEPT FOR 18 HOURS STRAIGHT; DRAINAGE WONT STOP; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergies, and other pre-existing medical conditions included: Patient takes medication for allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the patient experienced feels like burning up. On 14-JUL-2021, the patient experienced waking up in sweat. On 14-JUL-2021, the patient experienced runny nose. On 14-JUL-2021, the patient experienced sinus pressure. On 14-JUL-2021, the patient experienced sneezing. On 14-JUL-2021, the patient experienced wet coughing yellow mucus. On 14-JUL-2021, the patient experienced slept for 18 hours straight. On 14-JUL-2021, the patient experienced drainage wont stop. On 17-JUL-2021, Laboratory data included: Body temperature (NR: not provided) 97.8 F, 91.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feels like burning up, waking up in sweat, runny nose, sinus pressure, sneezing, slept for 18 hours straight, and drainage wont stop, and the outcome of wet coughing yellow mucus was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Rash, Rash pruritic, Urticaria
Clinical narrative: ITCHY RASH ON ARMS; RASH; RASH/HIVES ON BOTH ARMS FROM WRIST TO SHOULDER; SCRATCH EYES OUT; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816024, and expiry: 29-SEP-2021) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. Concomitant medications included clopidogrel bisulfate for heart disorder. On AUG-2021, the patient experienced scratch eyes out. On AUG-2021, the patient experienced rash. On AUG-2021, the patient experienced rash/hives on both arms from wrist to shoulder. On 06-AUG-2021, the patient experienced itchy rash on arms. Treatment medications (dates unspecified) included: camphor/diphenhydramine hydrochloride/zinc oxide, prednisone, betamethasone valerate, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchy rash on arms, and rash, had not recovered from rash/hives on both arms from wrist to shoulder, and the outcome of scratch eyes out was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: FAINTING (SYNCOPE) EPISODE; This spontaneous report received from a consumer concerned a 3 decade (approximately 23 year) old female of unknown race and ethnicity. 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, expiry: Unknown) 1 total, dose and 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 fainting (syncope) episode. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting (syncope) episode. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210834926.; Sender's Comments: V0:20210834795-COVID-19 VACCINE AD26.COV2.S-Fainting (syncope) episode. 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).
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: prostate cancer. 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAR-2021. This report was non-serious.