chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINATION ADMINISTERED FROM A VIAL AFTER POST PUNCTURE TIME PERIOD; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned an elderly male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced vaccination administered from a vial after post puncture time period. On 04-JUN-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination administered from a vial after post puncture time period and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210613154.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Sleep disorder
Clinical narrative: WOKE UP FROM SLEEP DUE TO PAIN; RIGHT ARM PAIN; RIGHT SHOULDER PAIN; This spontaneous report received from a consumer concerned an 80 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: 202A21A expiry: 23-JUN-2021) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced woke up from sleep due to pain. On 05-JUN-2021, the subject experienced right arm pain. On 05-JUN-2021, the subject experienced right shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain, right shoulder pain, and woke up from sleep due to pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist 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: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210612634, 20210612779 and 20210614876.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Nausea, Pyrexia
Clinical narrative: FELT LIKE KICKED HER ASS; FEVER 100 (PLUS) DEGREE; NAUSEA; This spontaneous report received from a consumer via a company representative 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 subject experienced felt like kicked her ass, fever 100 (plus) degree, and nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 plus degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 100 (plus) degree, nausea and felt like kicked her ass was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Headache, Injection site pain
Clinical narrative: PAIN IN THE  RIGHT ARM (FEELING OF LIKE BEING PUNCHED IN THE ARM); FEVER OF 101.2 DEGREE F; TIREDNESS (OVERWHELMINGLY TIRED); DULL HEADACHE; BODY WEAKNESS; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dermoid cyst, penicillin allergy, latex allergy, shellfish allergy, non alcohol user, cigarette smoker, and green peppers allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage.  The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-JUN-2021, the subject experienced body weakness. On 03-JUN-2021, the subject experienced dull headache. On 03-JUN-2021, the subject experienced tiredness (overwhelmingly tired). On 04-JUN-2021, the subject experienced pain in the right arm (feeling of like being punched in the arm). On 04-JUN-2021, the subject experienced fever of 101.2 degree f. Laboratory data included: Body temperature (NR: not provided) 101.2 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body weakness, dull headache, pain in the right arm (feeling of like being punched in the arm), fever of 101.2 degree f, and tiredness (overwhelmingly tired). This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PAIN IN THE  RIGHT ARM (FEELING OF LIKE BEING PUNCHED IN THE ARM); FEVER OF 101.2 DEGREE F; TIREDNESS (OVERWHELMINGLY TIRED); DULL HEADACHE; BODY WEAKNESS; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dermoid cyst, penicillin allergy, latex allergy, shellfish allergy, non alcohol user, cigarette smoker, and green peppers allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage.  The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-JUN-2021, the subject experienced body weakness. On 03-JUN-2021, the subject experienced dull headache. On 03-JUN-2021, the subject experienced tiredness (overwhelmingly tired). On 04-JUN-2021, the subject experienced pain in the right arm (feeling of like being punched in the arm). On 04-JUN-2021, the subject experienced fever of 101.2 degree f. Laboratory data included: Body temperature (NR: not provided) 101.2 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body weakness, dull headache, pain in the right arm (feeling of like being punched in the arm), fever of 101.2 degree f, and tiredness (overwhelmingly tired). This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF EXPIRED PRODUCT; This spontaneous report received from a pharmacist concerned a 69 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced administration of expired product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired product was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Head discomfort, Rash
Clinical narrative: PRESSURE ON THE HEAD (WOULD NOT CALL IT  HEADACHE); RED DOT ON UPPER THIGH; RASH ALL OVER BODY; This spontaneous report received from a patient concerned a 25 year old female. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced pressure on the head (would not call it headache). On 04-JUN-2021, the subject experienced rash all over body. On 04-JUN-2021, the subject experienced red dot on upper thigh. The action taken with covid-19 vaccine  was not applicable. The outcome of the rash all over body, pressure on the head (would not call it headache) and red dot on upper thigh was not reported. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vision blurred
Clinical narrative: BLURRY VISION; DIZZINESS; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced dizziness. On 27-MAY-2021, the subject experienced severe headache. On 04-JUN-2021, the subject experienced blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, blurry vision, and dizziness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Insomnia, Pollakiuria
Clinical narrative: NUMBNESS IN THE LEFT ARM; MILD HEADACHE; TROUBLE SLEEPING; URINATING VERY OFTEN, ALMOST EVERY HOUR; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204AZ1A, expiry: UNKNOWN) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced trouble sleeping. On 29-MAY-2021, the subject experienced urinating very often, almost every hour. On an unspecified date, the subject experienced numbness in the left arm, and mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble sleeping on 31-MAY-2021, urinating very often, almost every hour on 30-MAY-2021, and numbness in the left arm, and the outcome of mild headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Heart rate, Heart rate abnormal, Pain
Clinical narrative: BLURRED VISION KEEPS GETTING WORSE; UNSPECIFIED ABNORMAL HEART RATE; BODY ACHES; WEAKNESS; HEADACHE; 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 obesity. 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 24-MAY-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced blurred vision keeps getting worse. On MAY-2021, the subject experienced unspecified abnormal heart rate. On MAY-2021, the subject experienced body aches. On MAY-2021, the subject experienced weakness. On MAY-2021, the subject experienced headache. Laboratory data included: Heart rate (NR: not provided) Abnormal (values unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, blurred vision keeps getting worse, and unspecified abnormal heart rate, and the outcome of body aches and weakness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLURRED VISION KEEPS GETTING WORSE; UNSPECIFIED ABNORMAL HEART RATE; BODY ACHES; WEAKNESS; HEADACHE; 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 obesity. 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 24-MAY-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced blurred vision keeps getting worse. On MAY-2021, the subject experienced unspecified abnormal heart rate. On MAY-2021, the subject experienced body aches. On MAY-2021, the subject experienced weakness. On MAY-2021, the subject experienced headache. Laboratory data included: Heart rate (NR: not provided) Abnormal (values unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, blurred vision keeps getting worse, and unspecified abnormal heart rate, and the outcome of body aches and weakness was not reported. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Gait disturbance, Headache, Nausea
Clinical narrative: CAN BARELY WALK; WEAKNESS; FELT LIKE THROWING UP; HEADACHE; BACK STARTED TO HURT (TERRIBLE PAIN IN LOWER BACK); SORE ARM; This spontaneous report received from a patient concerned a 19 year old male. The patient's weight was 175 pounds, and height was 66 inches. The patient's concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included patient had no known allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced back started to hurt (terrible pain in lower back). On 03-JUN-2021, the subject experienced weakness. On 03-JUN-2021, the subject experienced felt like throwing up. On 03-JUN-2021, the subject experienced headache. On 04-JUN-2021, the subject experienced can barely walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and headache, had not recovered from felt like throwing up, weakness, and back started to hurt (terrible pain in lower back), and the outcome of can barely walk was not reported. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: CAN BARELY WALK; WEAKNESS; FELT LIKE THROWING UP; HEADACHE; BACK STARTED TO HURT (TERRIBLE PAIN IN LOWER BACK); SORE ARM; This spontaneous report received from a patient concerned a 19 year old male. The patient's weight was 175 pounds, and height was 66 inches. The patient's concurrent conditions included non-smoker, and non-alcohol user, and other pre-existing medical conditions included patient had no known allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced back started to hurt (terrible pain in lower back). On 03-JUN-2021, the subject experienced weakness. On 03-JUN-2021, the subject experienced felt like throwing up. On 03-JUN-2021, the subject experienced headache. On 04-JUN-2021, the subject experienced can barely walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and headache, had not recovered from felt like throwing up, weakness, and back started to hurt (terrible pain in lower back), and the outcome of can barely walk was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Medication error
Clinical narrative: TWO VACCINE ADMINISTERED FOR COVID-19 (MEDICATION ERROR); 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 past medical history included heart transplant. The patient was previously treated with Pfizer's covid-19 vaccine. 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 two vaccine administered for covid-19 (Medication error).  Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Antibodies went up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of two vaccine administered for covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20210611952.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Pain, Pyrexia
Clinical narrative: WOKE UP WITH PAIN AND BODY ACHES IN BACK AND LEFT SIDE AND FEELS LIKE THE PAIN IS ENLARGING; FEELING BAD; FELT FEVERISH; DIZZINESS; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart valve replacement, and concurrent conditions included abstains from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient has history of no drug drug abuse or illicit drug usage. the patient was taking blood thinning medications. 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 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021, the subject experienced dizziness. On 04-JUN-2021, the subject experienced feeling bad. On 04-JUN-2021, the subject experienced felt feverish. On 05-JUN-2021, the subject experienced woke up with pain and body aches in back and left side and feels like the pain is enlarging. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt feverish, dizziness, and woke up with pain and body aches in back and left side and feels like the pain is enlarging, and the outcome of feeling bad was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Influenza like illness, Pain in extremity, Spinal pain
Clinical narrative: FEELING ILL, COUGHING, SHARP HEADACHE PAIN AND MUSCLE ACHE; PAIN IN SPINE; VERY UPSET; SORE ARM; This spontaneous report received from a patient concerned a 59 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: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-JUN-2021, the subject experienced feeling ill, coughing, sharp headache pain and muscle ache. On 03-JUN-2021, the subject experienced pain in spine. On 03-JUN-2021, the subject experienced very upset. On 03-JUN-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and the outcome of feeling ill, coughing, sharp headache pain and muscle ache, pain in spine and very upset was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Cough, Dysstasia, Headache
Clinical narrative: BODY HURTS/PAIN; SWEATING; COUGHING; CANNOT SLEEP; HARD TIME STANDING ON MY FEET; FEELING VERY WEAK; FELT SICK; FEVER; 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, 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 body hurts/pain, sweating, coughing, cannot sleep, hard time standing on my feet, feeling very weak, felt sick, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 39.8, 37.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from headache, body hurts/pain, feeling very weak, sweating, coughing, and cannot sleep, and the outcome of hard time standing on my feet and felt sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Malaise, Pain, Pyrexia
Clinical narrative: BODY HURTS/PAIN; SWEATING; COUGHING; CANNOT SLEEP; HARD TIME STANDING ON MY FEET; FEELING VERY WEAK; FELT SICK; FEVER; 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, 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 body hurts/pain, sweating, coughing, cannot sleep, hard time standing on my feet, feeling very weak, felt sick, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 39.8, 37.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from headache, body hurts/pain, feeling very weak, sweating, coughing, and cannot sleep, and the outcome of hard time standing on my feet and felt sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS (HEADACHE, TIREDNESS, FATIGUE); This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced flu like symptoms (headache, tiredness, fatigue). Treatment medications (dates unspecified) included: naproxen sodium, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms (headache, tiredness, fatigue) on 01-JUN-2021. This report was non-serious. This case, involving the same patient is linked to 20210612409.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site bruising, Injection site erythema, Nausea
Clinical narrative: BRUISE 3 1/2 INCHES BELOW THE INJECTION SITE; INJECTION SITE REDNESS TO THE RIGHT ARM; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced nausea. On 27-MAY-2021, the subject experienced fatigue. On 29-MAY-2021, the subject experienced bruise 3 1/2 inches below the injection site. On 29-MAY-2021, the subject experienced injection site redness to the right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 27-MAY-2021, and fatigue on 30-MAY-2021, and was recovering from injection site redness to the right arm, and bruise 3 1/2 inches below the injection site. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHES; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Medication error
Clinical narrative: EXPIRED VACCINE USED; MEDICATION ERROR; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-JUN-2021, the subject experienced expired vaccine used. On 04-JUN-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine used and medication error was not reported. This report was non-serious The Product Quality complaint number: 90000181971
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: SUPPOSED TO ADMINISTER CHICKENPOX VACCINE NOT COVID-19 VACCINE; This spontaneous report received from a pharmacist 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 was previously treated with BNT 162 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced supposed to administer chickenpox vaccine not covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of supposed to administer chickenpox vaccine not covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RECEIVED EXPIRED VACCINE; This spontaneous report received from a physician 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 was not reported, administered on 05-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced received expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received expired vaccine was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Fatigue
Clinical narrative: INCREASED BLOOD PRESSURE; HOT FLASHES; SLEEPING ALL THE TIME; HIVES; CHILLS; FATIGUE/ EXTREMELY TIRED; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid cancer, previous gallbladder surgery, and tumor removal surgery, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included patient had allergy to steroids and zinc. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, cetirizine hydrochloride, pethidine hydrochloride, ibuprofen, morphine, and ketorolac tromethamine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: D42A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide, and losartan. On 2021, Laboratory data included: Blood pressure (NR: not provided) 150/90 (unit not reported). On 27-MAY-2021, the subject experienced increased blood pressure. On 27-MAY-2021, the subject experienced hot flashes. On 27-MAY-2021, the subject experienced sleeping all the time. On 27-MAY-2021, the subject experienced hives. On 27-MAY-2021, the subject experienced chills. On 27-MAY-2021, the subject experienced fatigue/ extremely tired. On 27-MAY-2021, the subject experienced headache. On 27-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Highest temperature 101 and normal temperature 96.7. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol, acetylsalicylic acid, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever on 2021, was recovering from chills, had not recovered from hives, and fatigue/ extremely tired, and the outcome of increased blood pressure, hot flashes and sleeping all the time was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Hypersomnia, Pyrexia, Urticaria
Clinical narrative: INCREASED BLOOD PRESSURE; HOT FLASHES; SLEEPING ALL THE TIME; HIVES; CHILLS; FATIGUE/ EXTREMELY TIRED; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid cancer, previous gallbladder surgery, and tumor removal surgery, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included patient had allergy to steroids and zinc. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, cetirizine hydrochloride, pethidine hydrochloride, ibuprofen, morphine, and ketorolac tromethamine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: D42A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide, and losartan. On 2021, Laboratory data included: Blood pressure (NR: not provided) 150/90 (unit not reported). On 27-MAY-2021, the subject experienced increased blood pressure. On 27-MAY-2021, the subject experienced hot flashes. On 27-MAY-2021, the subject experienced sleeping all the time. On 27-MAY-2021, the subject experienced hives. On 27-MAY-2021, the subject experienced chills. On 27-MAY-2021, the subject experienced fatigue/ extremely tired. On 27-MAY-2021, the subject experienced headache. On 27-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Highest temperature 101 and normal temperature 96.7. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol, acetylsalicylic acid, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever on 2021, was recovering from chills, had not recovered from hives, and fatigue/ extremely tired, and the outcome of increased blood pressure, hot flashes and sleeping all the time was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: LOUD TINNITUS IN BOTH EARS; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included tinnitus episodes, and concurrent conditions included penicillin allergy, and hear aid user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 2051A211A expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced loud tinnitus in both ears. On 05-JUN-2021, the subject experienced lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loud tinnitus in both ears, and lightheadedness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 84.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: TEMPERATURE EXCURSION VIALS ADMINISTERED; POOR QUALITY PRODUCT ADMINISTERED; This spontaneous report received from a pharmacist concerned an 84 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, route of admin not reported, batch number: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced temperature excursion vials administered. On 27-MAY-2021, the subject experienced poor quality product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality product administered and temperature excursion vials administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210612503, 20210612311 and 20210612749.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling cold, Genital herpes, Hyperhidrosis, Pain
Clinical narrative: LOWER BACK PAIN; KIDNEY PAIN IN THE KIDNEY AREA; PROFUSE SWEATING; BODY ACHES; FREEZING COLD; VICIOUS HERPES OUTBREAK (ANAL DISCOMFORT, PAINFUL BLISTERS ON LABIA, DISCOLORATION/PUFFY/YELLOW APPEARANCE OF ANAL AREA THAT GOT ITCHY/BURNY AND PAINFUL, HAD ANAL BUMPS, FEVER); DISRUPTED SLEEP (PAIN FROM THE BLISTER WAS KEEPING PATIENT FROM SLEEPING); This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included candida, and concurrent conditions included latex allergy, alcohol consumption, and non-smoker, and other pre-existing medical conditions included the patient had no history for drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced disrupted sleep (pain from the blister was keeping subject from sleeping). Treatment medications included: paracetamol. On 29-MAY-2021, the subject experienced vicious herpes outbreak (anal discomfort, painful blisters on labia, discoloration/puffy/yellow appearance of anal area that got itchy/burny and painful, had anal bumps, fever). On 01-JUN-2021, the subject experienced lower back pain. On 01-JUN-2021, the subject experienced kidney pain in the kidney area. On 01-JUN-2021, the subject experienced profuse sweating. On 01-JUN-2021, the subject experienced body aches. On 01-JUN-2021, the subject experienced freezing cold. On 02-JUN-2021, treatment medications included: fluconazole, and valaciclovir. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain, kidney pain in the kidney area, profuse sweating, and body aches on 04-JUN-2021, had not recovered from vicious herpes outbreak (anal discomfort, painful blisters on labia, discoloration/puffy/yellow appearance of anal area that got itchy/burny and painful, had anal bumps, fever), and the outcome of disrupted sleep (pain from the blister was keeping patient from sleeping) and freezing cold was not reported. This report was non-serious. This case, involving the same patient is linked to 20210614700.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain, Sleep disorder
Clinical narrative: LOWER BACK PAIN; KIDNEY PAIN IN THE KIDNEY AREA; PROFUSE SWEATING; BODY ACHES; FREEZING COLD; VICIOUS HERPES OUTBREAK (ANAL DISCOMFORT, PAINFUL BLISTERS ON LABIA, DISCOLORATION/PUFFY/YELLOW APPEARANCE OF ANAL AREA THAT GOT ITCHY/BURNY AND PAINFUL, HAD ANAL BUMPS, FEVER); DISRUPTED SLEEP (PAIN FROM THE BLISTER WAS KEEPING PATIENT FROM SLEEPING); This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included candida, and concurrent conditions included latex allergy, alcohol consumption, and non-smoker, and other pre-existing medical conditions included the patient had no history for drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced disrupted sleep (pain from the blister was keeping subject from sleeping). Treatment medications included: paracetamol. On 29-MAY-2021, the subject experienced vicious herpes outbreak (anal discomfort, painful blisters on labia, discoloration/puffy/yellow appearance of anal area that got itchy/burny and painful, had anal bumps, fever). On 01-JUN-2021, the subject experienced lower back pain. On 01-JUN-2021, the subject experienced kidney pain in the kidney area. On 01-JUN-2021, the subject experienced profuse sweating. On 01-JUN-2021, the subject experienced body aches. On 01-JUN-2021, the subject experienced freezing cold. On 02-JUN-2021, treatment medications included: fluconazole, and valaciclovir. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lower back pain, kidney pain in the kidney area, profuse sweating, and body aches on 04-JUN-2021, had not recovered from vicious herpes outbreak (anal discomfort, painful blisters on labia, discoloration/puffy/yellow appearance of anal area that got itchy/burny and painful, had anal bumps, fever), and the outcome of disrupted sleep (pain from the blister was keeping patient from sleeping) and freezing cold was not reported. This report was non-serious. This case, involving the same patient is linked to 20210614700.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Neck mass, Peripheral swelling
Clinical narrative: SWOLLEN HANDS AND FEET; TROUBLE WALKING; LUMP ON THE BACK OF THE NECK; This spontaneous report received from a patient concerned an elderly 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: Unk) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-APR-2021, the subject experienced swollen hands and feet. On 30-APR-2021, the subject experienced trouble walking. On 30-APR-2021, the subject experienced lump on the back of the neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen hands and feet, trouble walking, and lump on the back of the neck. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered
Clinical narrative: GOT AN EXPIRED DOSE OF THE VACCINE; LEFT OUT OF THE REFRIGERATOR LONGER THAN THE 6 HOURS AFTER IT WAS PUNCTURED; 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 pre-existing medical conditions included patient has no medical history. patient has healthy.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 05-JUN-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 05-JUN-2021, the subject experienced got an expired dose of the vaccine. On 05-JUN-2021, the subject experienced left out of the refrigerator longer than the 6 hours after it was punctured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left out of the refrigerator longer than the 6 hours after it was punctured and got an expired dose of the vaccine was not reported. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Joint swelling, Pain
Clinical narrative: ANKLES SWELLING; ANKLES REDNESS; IN PAIN AND HURTS TO WALK; This spontaneous report received from a consumer concerned a 28 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: 206A21A expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced in pain and hurts to walk. On 05-JUN-2021, the subject experienced ankles swelling. On 05-JUN-2021, the subject experienced ankles redness. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ankles swelling, and ankles redness, and the outcome of in pain and hurts to walk was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Injection site rash, Nausea, Pain in extremity
Clinical narrative: SORE ARM; RASH ON LEFT ARM AT ADMINISTRATION SITE (LEFT DELTOID)/3 OR 4 RASHES UNDER OR CLOSER TO THE ARMPIT (ABOUT 1-2 CENTIMETERS)/THE OTHER ONE BY INNER ELBOW/LIKE A MOSQUITO BITE THAT WELTS; HEADACHE; NAUSEA; BURNING; ITCHING; 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, intramuscular, batch number: 203a21a, expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced burning. On JUN-2021, the subject experienced itching. On 05-JUN-2021, the subject experienced sore arm. On 05-JUN-2021, the subject experienced rash on left arm at administration site (left deltoid) /3 or 4 rashes under or closer to the armpit (about 1-2 centimeters) /the other one by inner elbow/like a mosquito bite that welts. On 05-JUN-2021, the subject experienced headache. On 05-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on left arm at administration site (left deltoid)/3 or 4 rashes under or closer to the armpit (about 1-2 centimeters)/the other one by inner elbow/like a mosquito bite that welts, itching, burning, headache, sore arm and nausea was not reported. This report was non-serious.