chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea
Clinical narrative: HEAVY MENSTRUATION WITH PAINFUL CRAMPS; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: perimenopause. 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 14-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-AUG-2021, the patient experienced heavy menstruation with painful cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heavy menstruation with painful cramps was not reported. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a 23 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: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.2 F. On 17-AUG-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 had not recovered from fever. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Full blood count, Helicobacter test, Metabolic function test
Clinical narrative: STOMACH PAIN; TOOTH ABSCESS; VERTIGO; DIZZINESS; NAUSEA; This spontaneous report received from a consumer concerned a 64 year old female. The patient's weight was 130 pounds, and height was 66 inches. The patient's concurrent conditions included: alcohol use/seldomly drinks champagne, eggs allergy manifested by upset stomach, dust allergy manifested by watery eyes and sneezing, and no tobacco use. The patient experienced inflammation and skin rash in the injection site when treated with etanercept, and adalimumab.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: upadacitinib (tablet, oral, batch number was not reported) 15 mg, 1 time every 1 day from JAN-2021 to 12-MAR-2021, and 15 mg, 1 time every 1 day from 27-MAR-2021 to JUN-2021 for rheumatoid arthritis. Concomitant medications included sertraline for depression, thyroid for hypothyroidism, celecoxib for rheumatoid arthritis, and tramadol for rheumatoid arthritis, and pain.  On 13-MAR-2021, the patient experienced vertigo, dizziness, and nausea. On unspecified date in MAY-2021, the patient experienced tooth abscess. On 16-JUL-2021, the patient had removal of tooth because of the tooth abscess and had bone graft to replace the tooth. The patient had two rounds of antibiotics before pulling the tooth. On unspecified date in JUL-2021, the patient experienced stomach pain.  On 03-AUG-2021, Laboratory data included: Complete blood count (NR: not provided) No results reported, Comprehensive metabolic panel (NR: not provided) No results reported, and Helicobacter pylori identification test (NR: not provided) No results reported. Treatment medications (dates unspecified) included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo, and dizziness on 27-MAR-2021, tooth abscess on JUL-2021 and nausea on 10-AUG-2021, and was recovering from stomach pain. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and event tooth abscess as not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210836107-Covid-19 vaccine ad26.cov2.s-Tooth abscess . 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tooth abscess, Vertigo
Clinical narrative: STOMACH PAIN; TOOTH ABSCESS; VERTIGO; DIZZINESS; NAUSEA; This spontaneous report received from a consumer concerned a 64 year old female. The patient's weight was 130 pounds, and height was 66 inches. The patient's concurrent conditions included: alcohol use/seldomly drinks champagne, eggs allergy manifested by upset stomach, dust allergy manifested by watery eyes and sneezing, and no tobacco use. The patient experienced inflammation and skin rash in the injection site when treated with etanercept, and adalimumab.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: upadacitinib (tablet, oral, batch number was not reported) 15 mg, 1 time every 1 day from JAN-2021 to 12-MAR-2021, and 15 mg, 1 time every 1 day from 27-MAR-2021 to JUN-2021 for rheumatoid arthritis. Concomitant medications included sertraline for depression, thyroid for hypothyroidism, celecoxib for rheumatoid arthritis, and tramadol for rheumatoid arthritis, and pain.  On 13-MAR-2021, the patient experienced vertigo, dizziness, and nausea. On unspecified date in MAY-2021, the patient experienced tooth abscess. On 16-JUL-2021, the patient had removal of tooth because of the tooth abscess and had bone graft to replace the tooth. The patient had two rounds of antibiotics before pulling the tooth. On unspecified date in JUL-2021, the patient experienced stomach pain.  On 03-AUG-2021, Laboratory data included: Complete blood count (NR: not provided) No results reported, Comprehensive metabolic panel (NR: not provided) No results reported, and Helicobacter pylori identification test (NR: not provided) No results reported. Treatment medications (dates unspecified) included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo, and dizziness on 27-MAR-2021, tooth abscess on JUL-2021 and nausea on 10-AUG-2021, and was recovering from stomach pain. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and event tooth abscess as not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210836107-Covid-19 vaccine ad26.cov2.s-Tooth abscess . 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: Fatigue, Pain, Swelling
Clinical narrative: HURTING ALL OVER; SWOLLEN; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, and allergy to penicillin. The patient experienced drug did not work when treated with etanercept, and really bad memory issue when treated with methotrexate.  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. Concomitant medications included ascorbic acid, colecalciferol, folic acid/vitamin b12 nos, losartan potassium, nebivolol hydrochloride, and tofacitinib citrate.  On an unspecified date, the patient experienced hurting all over, swollen, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, hurting all over and swollen was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hyperhidrosis, Nausea, SARS-CoV-2 test
Clinical narrative: SWEATING; SHORT OF BREATH; CHILLS; VERY NAUSEOUS; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: graves disease, no alcohol use, smoker, and fibromyalgia, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with hydromorphone hydrochloride, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 09-APR-2021, the patient experienced sweating. On 09-APR-2021, the patient experienced short of breath. On 09-APR-2021, the patient experienced chills. On 09-APR-2021, the patient experienced very nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, short of breath, chills, and very nauseous on 17-APR-2021. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED AFTER 48 HOURS FROM PUNCTURED VIAL; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 49 year old male. The patient's height, and weight were not reported. The patient's 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: 204A21A expiry: 21-SEP-2021) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced incorrect product storage. On 17-AUG-2021, the patient experienced vaccine administered after 48 hours from punctured vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after 48 hours from punctured vial and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210837503.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bowel movement irregularity, Contusion, Headache, Pain
Clinical narrative: BOWEL ISSUES; BRUISING ON THE ARM/SHOULDER/ LEG; LOW PLATELET COUNT; UPPER BODY PAIN; SHOULDER PAIN; SHARP HEADACHE; RIGHT/LEFT LEG PAIN; 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: chronic migraine, and stress syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1806029 expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. Concomitant medications included topiramate for migraine. On 24-MAR-2021, the patient experienced right/left leg pain. On JUN-2021, the patient experienced bruising on the arm/shoulder/ leg. On JUN-2021, the patient experienced low platelet count. On JUN-2021, the patient experienced upper body pain. On JUN-2021, the patient experienced shoulder pain. On JUN-2021, the patient experienced sharp headache. Laboratory data included: Platelet count (NR: not provided) Low. On an unspecified date, the patient experienced bowel issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right/left leg pain, sharp headache, bruising on the arm/shoulder/ leg, low platelet count, upper body pain, and shoulder pain, and the outcome of bowel issues was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Platelet count, Platelet count decreased
Clinical narrative: BOWEL ISSUES; BRUISING ON THE ARM/SHOULDER/ LEG; LOW PLATELET COUNT; UPPER BODY PAIN; SHOULDER PAIN; SHARP HEADACHE; RIGHT/LEFT LEG PAIN; 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: chronic migraine, and stress syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1806029 expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. Concomitant medications included topiramate for migraine. On 24-MAR-2021, the patient experienced right/left leg pain. On JUN-2021, the patient experienced bruising on the arm/shoulder/ leg. On JUN-2021, the patient experienced low platelet count. On JUN-2021, the patient experienced upper body pain. On JUN-2021, the patient experienced shoulder pain. On JUN-2021, the patient experienced sharp headache. Laboratory data included: Platelet count (NR: not provided) Low. On an unspecified date, the patient experienced bowel issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right/left leg pain, sharp headache, bruising on the arm/shoulder/ leg, low platelet count, upper body pain, and shoulder pain, and the outcome of bowel issues was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness, SARS-CoV-2 antibody test
Clinical narrative: STIFFNESS; FELT A LITTLE MORE TIRED AND WENT TO BED A LITTLE EARLY; 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 pre-existing medical conditions included: The patient had no fever or sweating and was able to keep foot down and the patient had no other side effects. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUL-2021, Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) 98.7. On an unspecified date, the patient experienced stiffness, and felt a little more tired and went to bed a little early. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test (NR: not provided) Inconclusive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt a little more tired and went to bed a little early and stiffness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a male 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. No concomitant medications were reported. On AUG-2021, treatment medications included: ivermectin. On 18-AUG-2021, the patient experienced headache.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Urinary tract disorder, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; PROBLEM WITH URINATING; This spontaneous report received from a patient concerned a 51 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: 1808978, and expiry: unknown) dose was not reported, 1 total, administered on 05-JUN-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the patient was tested positive for COVID-19 PCR test (confirmed covid-19 infection and confirmed clinical vaccination failure). In JUL-2021, before test the patient was experiencing body pain, soreness of the body, pounding headache that went all the way to his back, fatigue and problem with urinating. Patient went to physician office. He recovered after 2 weeks being off from work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection and problem with urinating in AUG-2021, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210837367-JANSSEN COVID-19 VACCINE Ad26.COV2.S- confirmed 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.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Feeling cold
Clinical narrative: SUFFERED BAD REACTIONS; INTENSELY INTERNAL COLD FEELING; 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, 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 patient experienced suffered bad reactions, and intensely internal cold feeling. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suffered bad reactions and intensely internal cold feeling was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pain in extremity
Clinical narrative: 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: arthritis, and tingling in legs and feet. 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-MAR-2021 for prophylactic vaccination. The Batch number was not reported and it has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced chest tightness, and slightly sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, and slightly sore arm. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Oral pain, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; REALLY SORE MOUTH; NOT FEELING RIGHT; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 32 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: 1805020, expiry: not reported) dose was not reported, 1 total, administered on 09-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 12-AUG-2021, the patient was tested positive for coronavirus disease (Covid-19) (suspected clinical vaccination failure). Patient's only symptoms were sore mouth and he was not feeling right. Patient's primary care physician (PCP) was aware of the complaint. On an unknown date, patient experienced suspected covid-19 infection. Patient's wife (who had received the first dose of Moderna) and children (unvaccinated) were tested negative for COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection, really sore mouth and not feeling right was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210837418-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
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling cold, Headache, Injection site pain
Clinical narrative: BODY ACHE; BRAIN FOG; FELT LIKE A MILD BODY COLD; CHILLS; MILD FEVER; NAUSEA; HEADACHE; SORENESS AT THE SITE; This spontaneous report received from a patient 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, 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 body ache, brain fog, felt like a mild body cold, chills, mild fever, nausea, headache, and soreness at the site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like a mild body cold, and mild fever, and the outcome of soreness at the site, chills, body ache, nausea, brain fog and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHE; BRAIN FOG; FELT LIKE A MILD BODY COLD; CHILLS; MILD FEVER; NAUSEA; HEADACHE; SORENESS AT THE SITE; This spontaneous report received from a patient 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, 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 body ache, brain fog, felt like a mild body cold, chills, mild fever, nausea, headache, and soreness at the site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like a mild body cold, and mild fever, and the outcome of soreness at the site, chills, body ache, nausea, brain fog and headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: RECEIVED FIRST PFIZER VACCINE AFTER BEING ADMINSTERED WITH JANSSEN VACCINE; This spontaneous report received from a pharmacist concerned a male 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, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination. On JUL-2021, the patient experienced received first pfizer vaccine after being adminstered with janssen vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received first pfizer vaccine after being adminstered with janssen vaccine was not reported. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Chills, Disorientation, Fatigue
Clinical narrative: STARTED BEING SICK; FELT DISORIENTATED; STAYED IN BED; WHOLE BODY FELT WEIRD/FELT SO BAD; FEELING HOT; FELT LIKE ACHY IT'S HARD TO EXPLAIN; PRETTY MUCH ASLEEP; CHILLS; NAUSEATED; FEELING TIRED; HIGH FEVER; REALLY DID NOT FEEL WELL; FEEL COLD; HAD NOTHING TO EAT, DRANK GATORADE, AND WATER/UNABLE TO EAT; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight was 167 pounds, and height was 71 inches. The patient's past medical history included: couple knee surgeries a couple years ago, and concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and 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: 1808980 expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced had nothing to eat, drank gatorade, and water/unable to eat. On 16-AUG-2021, the patient experienced really did not feel well. On 16-AUG-2021, the patient experienced feel cold. On 16-AUG-2021, the patient experienced feeling tired. On 16-AUG-2021, the patient experienced high fever. On 17-AUG-2021, the patient experienced started being sick. On 17-AUG-2021, the patient experienced felt disorientated. On 17-AUG-2021, the patient experienced stayed in bed. On 17-AUG-2021, the patient experienced whole body felt weird/felt so bad. On 17-AUG-2021, the patient experienced feeling hot. On 17-AUG-2021, the patient experienced felt like achy it's hard to explain. On 17-AUG-2021, the patient experienced pretty much asleep. On 17-AUG-2021, the patient experienced chills. On 17-AUG-2021, the patient experienced nauseated. Laboratory data included: Body temperature (NR: not provided) 101 to 102 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, really did not feel well, whole body felt weird/felt so bad, felt like achy it's hard to explain, felt disorientated, feeling tired, nauseated, started being sick, feeling hot, stayed in bed, feel cold, and pretty much asleep, and the outcome of high fever and had nothing to eat, drank gatorade, and water/unable to eat was not reported. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling abnormal, Feeling cold, Feeling hot, Hypersomnia
Clinical narrative: STARTED BEING SICK; FELT DISORIENTATED; STAYED IN BED; WHOLE BODY FELT WEIRD/FELT SO BAD; FEELING HOT; FELT LIKE ACHY IT'S HARD TO EXPLAIN; PRETTY MUCH ASLEEP; CHILLS; NAUSEATED; FEELING TIRED; HIGH FEVER; REALLY DID NOT FEEL WELL; FEEL COLD; HAD NOTHING TO EAT, DRANK GATORADE, AND WATER/UNABLE TO EAT; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight was 167 pounds, and height was 71 inches. The patient's past medical history included: couple knee surgeries a couple years ago, and concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and 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: 1808980 expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced had nothing to eat, drank gatorade, and water/unable to eat. On 16-AUG-2021, the patient experienced really did not feel well. On 16-AUG-2021, the patient experienced feel cold. On 16-AUG-2021, the patient experienced feeling tired. On 16-AUG-2021, the patient experienced high fever. On 17-AUG-2021, the patient experienced started being sick. On 17-AUG-2021, the patient experienced felt disorientated. On 17-AUG-2021, the patient experienced stayed in bed. On 17-AUG-2021, the patient experienced whole body felt weird/felt so bad. On 17-AUG-2021, the patient experienced feeling hot. On 17-AUG-2021, the patient experienced felt like achy it's hard to explain. On 17-AUG-2021, the patient experienced pretty much asleep. On 17-AUG-2021, the patient experienced chills. On 17-AUG-2021, the patient experienced nauseated. Laboratory data included: Body temperature (NR: not provided) 101 to 102 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, really did not feel well, whole body felt weird/felt so bad, felt like achy it's hard to explain, felt disorientated, feeling tired, nauseated, started being sick, feeling hot, stayed in bed, feel cold, and pretty much asleep, and the outcome of high fever and had nothing to eat, drank gatorade, and water/unable to eat was not reported. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: STARTED BEING SICK; FELT DISORIENTATED; STAYED IN BED; WHOLE BODY FELT WEIRD/FELT SO BAD; FEELING HOT; FELT LIKE ACHY IT'S HARD TO EXPLAIN; PRETTY MUCH ASLEEP; CHILLS; NAUSEATED; FEELING TIRED; HIGH FEVER; REALLY DID NOT FEEL WELL; FEEL COLD; HAD NOTHING TO EAT, DRANK GATORADE, AND WATER/UNABLE TO EAT; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight was 167 pounds, and height was 71 inches. The patient's past medical history included: couple knee surgeries a couple years ago, and concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and 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: 1808980 expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced had nothing to eat, drank gatorade, and water/unable to eat. On 16-AUG-2021, the patient experienced really did not feel well. On 16-AUG-2021, the patient experienced feel cold. On 16-AUG-2021, the patient experienced feeling tired. On 16-AUG-2021, the patient experienced high fever. On 17-AUG-2021, the patient experienced started being sick. On 17-AUG-2021, the patient experienced felt disorientated. On 17-AUG-2021, the patient experienced stayed in bed. On 17-AUG-2021, the patient experienced whole body felt weird/felt so bad. On 17-AUG-2021, the patient experienced feeling hot. On 17-AUG-2021, the patient experienced felt like achy it's hard to explain. On 17-AUG-2021, the patient experienced pretty much asleep. On 17-AUG-2021, the patient experienced chills. On 17-AUG-2021, the patient experienced nauseated. Laboratory data included: Body temperature (NR: not provided) 101 to 102 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, really did not feel well, whole body felt weird/felt so bad, felt like achy it's hard to explain, felt disorientated, feeling tired, nauseated, started being sick, feeling hot, stayed in bed, feel cold, and pretty much asleep, and the outcome of high fever and had nothing to eat, drank gatorade, and water/unable to eat was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chills, Gait inability, Pain in extremity, Pyrexia
Clinical narrative: CHILLS; SORE ARM AND LEG PAIN; FEVER; COULD NOT WALK FOR 3 WEEKS; 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: Patient had some severe reactions and patient cannot take aspirin or ibuprofen. 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-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 could not walk for 3 weeks. On 11-MAR-2021, the patient experienced chills. On 11-MAR-2021, the patient experienced sore arm and leg pain. On 11-MAR-2021, the patient experienced fever. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Positive. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not walk for 3 weeks, and chills, sore arm and leg pain, and fever on 11-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dependence on respirator, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: PUT ON A VENTILATOR; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a 94 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: controlled diabetes, high blood pressure, and atrial fibrillation. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced suspected covid-19 infection and suspected clinical vaccination failure. On 18-AUG-2021, he was put on a ventilator, and was hospitalized on an unspecified date. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, COVID-19 virus test (NR: not provided) Positive, and Weight (NR: not provided) Normal. The action taken with covid-19 vaccine was not applicable. The outcome of the put on a ventilator, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0:20210837488- covid-19 vaccine PUT ON A VENTILATOR,SUSPECTED COVID-19 INFECTION. 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).  20210837488- covid-19 vaccine 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
Sex: M
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: PUT ON A VENTILATOR; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a 94 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: controlled diabetes, high blood pressure, and atrial fibrillation. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced suspected covid-19 infection and suspected clinical vaccination failure. On 18-AUG-2021, he was put on a ventilator, and was hospitalized on an unspecified date. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, COVID-19 virus test (NR: not provided) Positive, and Weight (NR: not provided) Normal. The action taken with covid-19 vaccine was not applicable. The outcome of the put on a ventilator, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0:20210837488- covid-19 vaccine PUT ON A VENTILATOR,SUSPECTED COVID-19 INFECTION. 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).  20210837488- covid-19 vaccine 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
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: FEET/ANKLES FEEL LIKE STUCK THEM IN A HOT BUCKET OF WATER; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient have no change in colour or swelling. 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 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-AUG-2021, the patient experienced feet/ankles feel like stuck them in a hot bucket of water. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feet/ankles feel like stuck them in a hot bucket of water. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VIAL PUNCTURED OVER 48 HOURS WHEN ADMINISTERED; This spontaneous report received from a health care professional concerned a 54 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 allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, the patient experienced vial punctured over 48 hours when administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vial punctured over 48 hours when administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210838123, 20210837775 and 20210837262.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: PAIN IN RIGHT SHOULDER; PAIN IN RIGHT ARM; This spontaneous report received from a patient concerned an 8 decade old female. The patient's weight was 200 pounds, 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: Unknown) dose was not reported, administered on 10-MAR-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 patient experienced pain in right shoulder, and pain in right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right shoulder, and pain in right arm. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Muscle twitching
Clinical narrative: TWITCHING IN CALVES THAT DESCRIBED AS THE PULSATIONS IN THE BACK OF THE CALVESTWITCHING IN CALVES THAT DESCRIBED AS THE PULSATIONS IN THE BACK OF THE CALVES; HEADACHE; INJECTION SITE 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 concurrent conditions included: narcotic pain medications allergy. 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 16-AUG-2021 for prophylactic vaccination. Concomitant medications included ananas comosus/animal bone marrow/binetrakin/centella asiatica/interferon gamma/interleukin-1/interleukin-2/interleukin-6/thymus gland/vaccinium vitis-idaea, ascorbic acid, bifidobacterium lactis, ergocalciferol, sambucus nigra, and zinc. On AUG-2021, the patient experienced injection site pain. On 17-AUG-2021, the patient experienced headache. Treatment medications included: paracetamol. On 18-AUG-2021, the patient experienced twitching in calves that described as the pulsations in the back of the calvestwitching in calves that described as the pulsations in the back of the calves. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 17-AUG-2021, and injection site pain on AUG-2021, and had not recovered from twitching in calves that described as the pulsations in the back of the calvestwitching in calves that described as the pulsations in the back of the calves. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Tinnitus
Clinical narrative: TINNITUS/RINGING IN THE EARS; VERY SICK; 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: Unk) 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 MAY-2021, the patient experienced very sick. On an unspecified date, the patient experienced tinnitus/ringing in the ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick, and had not recovered from tinnitus/ringing in the ears. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Miliaria
Clinical narrative: HUGE HEAT RASH THAT COVERS ABOUT 25% OF RIGHT SIDE TORSO NEAR THE BREAST AND ALMOST EXTENDS TO THE BACK AND STOMACH; This spontaneous report received from a patient concerned a 26 year old female. The patient's weight was 264 pounds, and height was 64 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: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-AUG-2021, the patient experienced huge heat rash that covers about 25% of right side torso near the breast and almost extends to the back and stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from huge heat rash that covers about 25% of right side torso near the breast and almost extends to the back and stomach. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pain
Clinical narrative: BODY IN PAINING; I FEEL COLD; HEADACHE; This spontaneous report received from a patient 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 was not reported, administered on 29-JUL-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 29-JUL-2021, the patient experienced body in paining. On 29-JUL-2021, the patient experienced I feel cold. On 29-JUL-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, I feel cold and body in paining was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a consumer via a company representative 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, 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 sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.