chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: LOWER BACK STIFFNESS; ITCHY; LEFT FOOT PAIN; LEFT ANKLE PAIN KNEE PAIN AND JOINT PAIN; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight was 200 pounds, and height was 65 inches. The patient's concurrent conditions included crohn's disease, alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no drug drug abuse or illicit drug use. The patient's mother had history of blood clots due to cancer and chemo. The patient experienced burning in mouth, redness face, stomach pain and tenderness when treated with clarithromycin, clindamycin, metronidazole for drug used for unknown indication, and itchy rash when treated with oxycodone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: 09-JUL-2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for drug used for unknown indication, and mesalazine. On 01-APR-2021, the subject experienced left foot pain. On 01-APR-2021, the subject experienced left ankle pain knee pain and joint pain. Treatment medications included: ibuprofen. On 02-APR-2021, the subject experienced itchy. Laboratory data included: Antibody test (NR: not provided) negative. On 20-APR-2021, Laboratory data included: Antibody test (NR: not provided) negative. On MAY-2021, Laboratory data included: Ultrasound Doppler (NR: not provided) Negative for veinous thrombosis blood clots. On 03-MAY-2021, Laboratory data included: Antibody test (NR: not provided) negative. On 17-MAY-2021, the subject experienced lower back stiffness. On 20-MAY-2021, Laboratory data included: Antibody test (NR: not provided) negative. On 09-JUN-2021, treatment medications included: famotidine/ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy on 03-APR-2021, and had not recovered from left foot pain, lower back stiffness, and left ankle pain knee pain and joint pain. This report was non-serious. This case, from the same reporter is linked to 20210664067.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered
Clinical narrative: DOSE ADMINISTERED AFTER ACCEPTABLE TIME FRAME AFTER VIAL PUNCTURE; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a pharmacist 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dose administered after acceptable time frame after vial puncture, and poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dose administered after acceptable time frame after vial puncture and poor quality vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: LACK OF EFFECT; This spontaneous report received from a pharmacist concerned a female 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 was previously treated with covid-19 vaccine (Pfizer covid-19 vaccine) for drug used for unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on 11-APR-2021 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 lack of effect after vaccination. It was reported that, the patient had initially taken first dose Pfizer covid-19 vaccine, later Janssen Covid-19 Vaccine, and wants to take second dose of Pfizer vaccine for extra coverage. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lack of effect was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210666779 - COVID-19 VACCINE AD26.COV2.S- Lack of effect. 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: Illness, Nodule, Skin warm
Clinical narrative: SICK; STILL HAS A KNOT; WARM TO TOUCH; This spontaneous report received from a consumer on 25-JUN-2021 and 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was reported and has been requested. Concomitant medications included tofacitinib citrate for drug used for unknown indication. On an unspecified date, the subject experienced sick, still has a knot, and warm to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick, still has a knot and warm to touch was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: SUPERFICIAL BLOOD CLOT IN RIGHT LEG, UPPER THIGH AND VARICOSE VEINS; This spontaneous report was received from a 68-year-old female patient. The patient's height, and weight were not reported. The patient's past medical history included headache, and asthma. Concurrent conditions included high blood pressure (under control with medicines), diabetes (diagnosed 2 years ago; under control with medicines), tetracycline allergy (caused headache), and allergy to cats, dogs, horses, tree (caused asthma). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1800031 or 1805031, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 03-MAR-2021 for prophylactic vaccination. The patient was on unspecified medications for high blood pressure and diabetes. On 25-MAY-2021 (two and half month after vaccination), the patient noticed tenderness, warmth on touch, redness, and red lines in the upper inner thigh (above the knee) of the right leg. On 31-MAY-2021, the patient went to the immediate care, and the doctor diagnosed her leg as a superficial blood clot in the leg, thigh and varicose vein. Ultrasound was not available so healthcare professional (HCP) recommended the patient to see her primary HCP the next day. On 01-JUN-2021 (Tuesday), the patient went to her primary HCP (internist). The internist looked at patient's leg and confirmed the diagnosis as a superficial blood clot. On 02-JUN-2021 (Wednesday), at 08:45, she went to the vein specialist and the first ultrasound was performed. Once again, a diagnosis of superficial blood clot in varicose vein was confirmed. On 09-JUN-2021 (one week later), the patient returned for a second ultrasound to make sure the clot did not get any bigger and no improvement was noted. The patient was prescribed oral Aspirin 325 mg, 1 tablet, twice a day (BID) by the doctor. On 29-JUN-2021, the patient stated that she felt better. However, on the same day, a third ultrasound was performed by the ultrasound technician who noticed no improvement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from superficial blood clot in right leg, upper thigh and varicose veins. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210666967-covid-19 vaccine ad26.cov2.s -Superficial blood clot in right leg, upper thigh and varicose veins. 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: U
Vaccine: COVID19
Symptoms: Medication error, Product temperature excursion issue
Clinical narrative: COVID19 VACCINE IN THE FREEZER AND HAD TEMPERATURE EXCURSIONS WITH A HIGH TEMPERATURE; MEDICATION ERROR; This spontaneous report received from a consumer 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced covid19 vaccine in the freezer and had temperature excursions with a high temperature, and medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid19 vaccine in the freezer and had temperature excursions with a high temperature and medication error was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; 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 ustekinumab (solution for injection in pre-filled syringe, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ustekinumab was not reported. The outcome of unspecified adverse event was not reported. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Death, Dyspnoea
Clinical narrative: DYSSTASIA; COVID-19; SARS-COV-2 TEST POSITIVE; ASTHENIA; FATIGUE; DYSPNOEA; COUGH; PAIN; ILLNESS; DEATH; This spontaneous report received from a health care professional concerned an 80 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and hypertension. The patient experienced drug allergy in past when treated with ACE (angiotensin-converting-enzyme) inhibitors for an unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: unknown) dose was not reported, frequency time was 1 total administered on left arm on 30-APR-2021 for prophylactic vaccination. Concomitant medications included Amlodipine, Atorvastatin, Bupropion, Escitalopram, Furosemide, Lantus (insulin glargine), Levothyroxine, Metoprolol, Mirtazapine and Pantoprazole for an unknown indication.  On an unspecified date in MAY-2021 (reported as about 8 days after vaccination), the patient developed cough, aches, fatigue, and shortness of breath. After another 10 days of illness, the patient was taken to the hospital by ambulance as she was too weak to stand. On 22-MAY-2021, the patient experienced Covid-19, dysstasia and she had her SARS-COV-2 (severe acute respiratory syndrome coronavirus 2) test positive. On an unspecified date in MAY-2021 (reported as on or about 22-MAY-2021), the patient died from unknown cause of death in hospital about 5 days later. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on MAY-2021, and had not recovered from asthenia, cough, covid-19, dyspnoea, dysstasia, fatigue, illness, pain, and sars-cov-2 test positive. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments:  -covid-19 vaccine ad26.cov2.s. Death, cough, covid-19, dyspnea, dysstasia, illness, pain, and sars-cov-2 test positive. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the covid-19 vaccine ad26.cov2.s. Asthenia , fatigue, This events are labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fatigue, Illness, Pain, SARS-CoV-2 test
Clinical narrative: DYSSTASIA; COVID-19; SARS-COV-2 TEST POSITIVE; ASTHENIA; FATIGUE; DYSPNOEA; COUGH; PAIN; ILLNESS; DEATH; This spontaneous report received from a health care professional concerned an 80 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and hypertension. The patient experienced drug allergy in past when treated with ACE (angiotensin-converting-enzyme) inhibitors for an unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: unknown) dose was not reported, frequency time was 1 total administered on left arm on 30-APR-2021 for prophylactic vaccination. Concomitant medications included Amlodipine, Atorvastatin, Bupropion, Escitalopram, Furosemide, Lantus (insulin glargine), Levothyroxine, Metoprolol, Mirtazapine and Pantoprazole for an unknown indication.  On an unspecified date in MAY-2021 (reported as about 8 days after vaccination), the patient developed cough, aches, fatigue, and shortness of breath. After another 10 days of illness, the patient was taken to the hospital by ambulance as she was too weak to stand. On 22-MAY-2021, the patient experienced Covid-19, dysstasia and she had her SARS-COV-2 (severe acute respiratory syndrome coronavirus 2) test positive. On an unspecified date in MAY-2021 (reported as on or about 22-MAY-2021), the patient died from unknown cause of death in hospital about 5 days later. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on MAY-2021, and had not recovered from asthenia, cough, covid-19, dyspnoea, dysstasia, fatigue, illness, pain, and sars-cov-2 test positive. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments:  -covid-19 vaccine ad26.cov2.s. Death, cough, covid-19, dyspnea, dysstasia, illness, pain, and sars-cov-2 test positive. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the covid-19 vaccine ad26.cov2.s. Asthenia , fatigue, This events are labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: DYSSTASIA; COVID-19; SARS-COV-2 TEST POSITIVE; ASTHENIA; FATIGUE; DYSPNOEA; COUGH; PAIN; ILLNESS; DEATH; This spontaneous report received from a health care professional concerned an 80 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and hypertension. The patient experienced drug allergy in past when treated with ACE (angiotensin-converting-enzyme) inhibitors for an unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: unknown) dose was not reported, frequency time was 1 total administered on left arm on 30-APR-2021 for prophylactic vaccination. Concomitant medications included Amlodipine, Atorvastatin, Bupropion, Escitalopram, Furosemide, Lantus (insulin glargine), Levothyroxine, Metoprolol, Mirtazapine and Pantoprazole for an unknown indication.  On an unspecified date in MAY-2021 (reported as about 8 days after vaccination), the patient developed cough, aches, fatigue, and shortness of breath. After another 10 days of illness, the patient was taken to the hospital by ambulance as she was too weak to stand. On 22-MAY-2021, the patient experienced Covid-19, dysstasia and she had her SARS-COV-2 (severe acute respiratory syndrome coronavirus 2) test positive. On an unspecified date in MAY-2021 (reported as on or about 22-MAY-2021), the patient died from unknown cause of death in hospital about 5 days later. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on MAY-2021, and had not recovered from asthenia, cough, covid-19, dyspnoea, dysstasia, fatigue, illness, pain, and sars-cov-2 test positive. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments:  -covid-19 vaccine ad26.cov2.s. Death, cough, covid-19, dyspnea, dysstasia, illness, pain, and sars-cov-2 test positive. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the covid-19 vaccine ad26.cov2.s. Asthenia , fatigue, This events are labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Therapy partial responder
Clinical narrative: VACCINE NOT BEEN AS EFFECTIVE; This solicited report received from a physician via JS2020-26741: Healthcare Dialogue concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine not been as effective. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine not been as effective was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and lack of effectiveness as related. Company causality between covid-19 vaccine ad26.cov2.s, and lack of effectiveness was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210700371-Covid-19 vaccine ad26.cov2.s- "vaccine not been as effective". 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: 49.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID 19; This spontaneous report received from a patient concerned a 49 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, and batch number: 11817 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced tested positive for covid 19. Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 10-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid 19 was not reported. This report was non-serious. This case is associated with a product quality complaint number 90000184582.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Magnetic resonance imaging
Clinical narrative: FATIGUE/EXHAUSTION; This spontaneous report received from a patient via a company representative concerned a 19 year old female. The patient's height, and weight were not reported. The patient's past medical history included tumor pressing on spinal cord.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced fatigue/exhaustion. Laboratory data (dates unspecified) included: MRI (NR: not provided) MRI highlighted a tumor pressing on subject's spinal cord. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue/exhaustion. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: BODY SORENESS; INTENSE HEADACHE; This spontaneous report received from a patient 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 subject experienced body soreness, and intense headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the intense headache and body soreness was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: HEADACHE; DIZZINESS; This spontaneous report received from a patient concerned a 67 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: 103AZ1A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizziness. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and the outcome of headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210702102 and 20210701921.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eructation, Fatigue, Feeling abnormal, Headache
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTRATION; BRAIN FOG; STOMACHACHE; NOXIOUS BURPS; FEVER; HEADACHE; FATIGUE; 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 was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included bnt 162 for prophylactic vaccination. On APR-2021, the subject experienced brain fog. On APR-2021, the subject experienced stomachache. On APR-2021, the subject experienced noxious burps. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fatigue. On 22-JUN-2021, the subject experienced inappropriate schedule of vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain fog, stomachache, noxious burps, fever, headache, and fatigue, and the outcome of inappropriate schedule of vaccine administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210661890.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTRATION; BRAIN FOG; STOMACHACHE; NOXIOUS BURPS; FEVER; HEADACHE; FATIGUE; 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 was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included bnt 162 for prophylactic vaccination. On APR-2021, the subject experienced brain fog. On APR-2021, the subject experienced stomachache. On APR-2021, the subject experienced noxious burps. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fatigue. On 22-JUN-2021, the subject experienced inappropriate schedule of vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain fog, stomachache, noxious burps, fever, headache, and fatigue, and the outcome of inappropriate schedule of vaccine administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210661890.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: WHOLE BODY ACHE AND PAIN; FEVER; This spontaneous report received from a parent concerned a 25 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: Unk) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-JUL-2021, the subject experienced whole body ache and pain. On 01-JUL-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 102.8 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and whole body ache and pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis
Clinical narrative: SWEATING; NIGHT CHILLS; 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 patient was allergic to a unspecified medications. The patient experienced drug allergy when treated with influenza vaccine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 28-JUN-2021, the subject experienced sweating. On 28-JUN-2021, the subject experienced night chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from night chills, and sweating. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Hyperhidrosis, SARS-CoV-2 test, Sinus disorder
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS; SWEATING; This spontaneous report received from a Pfizer on 25-JUN-2021 and concerned a 42 year old male. The patient's weight was 99.79 kilograms, and height was 191 centimeters. The patient's concurrent conditions included non smoker and patient had no medical history. He had no known allergies and no current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAR-2021 to right arm at 08:30 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in May 2021, patient underwent blood work a week before he knew he had COVID. On 02-JUN-2021, the patient experienced sinus, fever, body aches, diarrhea, congestion, nausea, headache, mild cough and sweating. On the same day, patient underwent SARS-CoV-2 rapid diagnostic test and the results came out to be positive. On an unspecified date the patient underwent SARS-COV-2 PCR TEST and the results came out to be positive (confirmed covid-19 infection and confirmed clinical vaccination failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sinus, and sweating on JUN-2021, was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210701758 -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.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS; SWEATING; This spontaneous report received from a Pfizer on 25-JUN-2021 and concerned a 42 year old male. The patient's weight was 99.79 kilograms, and height was 191 centimeters. The patient's concurrent conditions included non smoker and patient had no medical history. He had no known allergies and no current illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAR-2021 to right arm at 08:30 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in May 2021, patient underwent blood work a week before he knew he had COVID. On 02-JUN-2021, the patient experienced sinus, fever, body aches, diarrhea, congestion, nausea, headache, mild cough and sweating. On the same day, patient underwent SARS-CoV-2 rapid diagnostic test and the results came out to be positive. On an unspecified date the patient underwent SARS-COV-2 PCR TEST and the results came out to be positive (confirmed covid-19 infection and confirmed clinical vaccination failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sinus, and sweating on JUN-2021, was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210701758 -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: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Body temperature, Pyrexia
Clinical narrative: STARTED FEELING THE EFFECTS  INSTANTLY; RUNNING A 100 DEGREE FEVER; This spontaneous report received from a patient 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 subject experienced started feeling the effects instantly, and running a 100 degree fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 DEGREE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the started feeling the effects instantly and running a 100 degree fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Somnolence
Clinical narrative: DROWSINESS; SORENESS; SHIVERS; FEVER; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced drowsiness, soreness, shivers, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drowsiness, soreness, shivers, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: SERIOUS SIDE EFFECTS; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced serious side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from serious side effects. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Amenorrhoea
Clinical narrative: Missed period and bloating . I?ve never missed a period before
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a patient concerned a 26 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, and batch number were not reported) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness. This report was non-serious. This case, from the same reporter is linked to 20210701429 and 20210702102.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED AFTER TEMPERATURE EXCURSION OCURRED BUT UNKNOWN TO PROVIDER; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional 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: 206A21A expiry: 07-AUG-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced vaccine administered after temperature excursion ocurred but unknown to provider. On 24-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after temperature excursion ocurred but unknown to provider and out of specification product use was not reported. This report was non-serious.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: INSULIN NEEDLE TO ADMINISTER JANSSEN COVID-19 VACCINE WITH INJECTED IT AT 90 DEGREE ANGLE; This spontaneous report received from a physician via a company representative concerned a 6 decade old of unspecified 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 was not reported, administered on 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 MAY-2021, the subject experienced insulin needle to administer janssen covid-19 vaccine with injected it at 90 degree angle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of insulin needle to administer janssen covid-19 vaccine with injected it at 90 degree angle was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Eructation, Headache, Pyrexia
Clinical narrative: STOMACH ACHE; BURPS LIKE VOMIT; TYPICAL CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient 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 subject experienced stomach ache, burps like vomit, typical chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach ache, burps like vomit, typical chills, fever, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: FROZEN VACCINE WAS THAWED AND GIVEN TO PATIENT; This spontaneous report received from a pharmacist concerned a 56 year old of unspecified 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, intramuscular, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced frozen vaccine was thawed and given to subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of frozen vaccine was thawed and given to patient was not reported. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Influenza like illness
Clinical narrative: ABDOMINAL PAIN; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 79 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, and batch number: 207A21A expiry: 07-AUG-2021) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUN-2021, the subject experienced flu-like symptoms. On 28-JUN-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and the outcome of abdominal pain was not reported. This report was non-serious.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Eyelids pruritus, Fatigue, Feeling abnormal, Headache, Lymphadenopathy
Clinical narrative: ITCHING OF EYELIDS; GLANDS ARE SWOLLEN BETWEEN TEMPLES AND EARS; INCREASED BATHROOM USE; HURT ALL OVER; TINGLING ON LEFT SIDE; ITCHING OF EYEBROW/ITCHING; FEEL LIKE EATEN A SOUR CANDY; GOT NAUSEATED; HEADACHE; TIRED; This spontaneous report received from a patient concerned a 63 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included neuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: HT365, and expiry: 03/AUG/2021) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUN-2021, the subject experienced itching of eyelids. On 30-JUN-2021, the subject experienced glands are swollen between temples and ears. On 30-JUN-2021, the subject experienced increased bathroom use. On 30-JUN-2021, the subject experienced hurt all over. On 30-JUN-2021, the subject experienced tingling on left side. On 30-JUN-2021, the subject experienced itching of eyebrow/itching. On 30-JUN-2021, the subject experienced feel like eaten a sour candy. On 30-JUN-2021, the subject experienced got nauseated. On 30-JUN-2021, the subject experienced headache. On 30-JUN-2021, the subject experienced tired. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching of eyelids, glands are swollen between temples and ears, tired, got nauseated, increased bathroom use, hurt all over, headache, tingling on left side, itching of eyebrow/itching and feel like eaten a sour candy was not reported. This report was non-serious.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain, Paraesthesia, Pollakiuria, Pruritus
Clinical narrative: ITCHING OF EYELIDS; GLANDS ARE SWOLLEN BETWEEN TEMPLES AND EARS; INCREASED BATHROOM USE; HURT ALL OVER; TINGLING ON LEFT SIDE; ITCHING OF EYEBROW/ITCHING; FEEL LIKE EATEN A SOUR CANDY; GOT NAUSEATED; HEADACHE; TIRED; This spontaneous report received from a patient concerned a 63 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included neuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: HT365, and expiry: 03/AUG/2021) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUN-2021, the subject experienced itching of eyelids. On 30-JUN-2021, the subject experienced glands are swollen between temples and ears. On 30-JUN-2021, the subject experienced increased bathroom use. On 30-JUN-2021, the subject experienced hurt all over. On 30-JUN-2021, the subject experienced tingling on left side. On 30-JUN-2021, the subject experienced itching of eyebrow/itching. On 30-JUN-2021, the subject experienced feel like eaten a sour candy. On 30-JUN-2021, the subject experienced got nauseated. On 30-JUN-2021, the subject experienced headache. On 30-JUN-2021, the subject experienced tired. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching of eyelids, glands are swollen between temples and ears, tired, got nauseated, increased bathroom use, hurt all over, headache, tingling on left side, itching of eyebrow/itching and feel like eaten a sour candy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VACCINATED 17 YEARS OLD (OFF LABEL PATIENT AGE); PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a pharmacist concerned a 17 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced vaccinated 17 years old (off label subject age), and product administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccinated 17 years old (off label patient age) and product administered to patient of inappropriate age was not reported. This report was non-serious.