chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 49 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: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient 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 20210958423, 20210958321, 20210958993 and 20210958249.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 40 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: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958566, 20210958806, 20210959351, 20210958321, 20210958348, 20210958371, 20210958425, 20210958977, 20210959620, 20210958525, 20210959581 and 20210959909.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional 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 (suspension for injection, route of admin not reported and batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958806, 20210958566 and 20210959351. This case, from the Others is linked to 20210958716.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 26-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-SEP-2021, the patient 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. This case, from the same reporter is linked to 20210958564, 20210958570, 20210958784 and 20210959706.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia
Clinical narrative: FEVER; FELT WEAK; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced fever, and felt weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and felt weak was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a physician concerned a 63 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958784, 20210958534 and 20210958570.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 24 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: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958425, 20210958525, 20210958716, 20210958371, 20210958806, 20210958977, 20210958518 and 20210958348.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 46 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: 2052A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958564, 20210958534, 20210958784 and 20210959706.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: SHIVERING AND CHILLS; This spontaneous report received from a parent concerned a 24 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: Unknown) dose was not reported, administered on 28-SEP-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 shivering and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shivering and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Pain in extremity
Clinical narrative: WARM; SWEATING (ON THE SECOND DAY); SORE ARM THE FIRST DAY AFTER THE SHOT; This spontaneous report received from a consumer concerned an 18 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 APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the patient experienced warm. On APR-2021, the patient experienced sweating (on the second day). On APR-2021, the patient experienced sore arm the first day after the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm the first day after the shot, warm and sweating (on the second day) was not reported. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pharyngeal swelling
Clinical narrative: THROAT SWELLING; MINOR HEADACHE; EXCRUCIATING SHOULDER PAIN (LEFT); This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included: excruciating pain in different body areas, and concurrent conditions included: sulfa drug allergies, non smoker, non alcoholic, and penicillin allergy. The patient was previously treated with varicella zoster vaccine rge (cho) for prophylactic vaccination.  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 17-SEP-2021 19:00 for prophylactic vaccination. Concomitant medications included gabapentin for shingles flareup.  On 17-SEP-2021, the patient experienced excruciating shoulder pain (left). On 20-SEP-2021, the patient experienced throat swelling. On 20-SEP-2021, the patient experienced minor headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat swelling, and minor headache on SEP-2021, and excruciating shoulder pain (left) on 20-SEP-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSELY AFFECTED BY THE JANSSEN COVID-19 VACCINE; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adversely affected by the Janssen covid-19 vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of adversely affected by the janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210960302.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 45 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, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient 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 20210958566, 20210958321, 20210958525 and 20210958993.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimoto's disease, seasonal allergies, and irritable bowel syndrome. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-SEP-2021, the patient experienced confirmed covid-19 infection. On 18-SEP-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On 24-SEP-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious. This case, from the same reporter is linked to 20210958772.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies, and other pre-existing medical conditions included: Patient was healthy, did not have any chronic conditions and medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-SEP-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 15-SEP-2021, in the morning the patient had bad fever. On 17-SEP-2021, the patient had a tele-visit with his doctor who suggested patient to take a COVID-19 PCR (coronavirus 19 polymerase chain reaction) test, which came back to positive (confirmed covid-19 infection) with symptoms of cough, headache, fatigue and fever. On 19-SEP-2021, Laboratory data included: Body temperature (NR: not provided) 103.8 F. Treatment medications included: ibuprofen, and paracetamol (given every 4-6 hours to keep fever down) and fever went at 9 to 10. On 20-SEP-2021, the patient went to hospital/clinic where patient received antibiotics, inhaler, CIPAP (continuous positive airway pressure therapy), and a monoclonal infusion as corrective treatment. On the same day, Laboratory data included: Body temperature (NR: not provided) 102 F. The patient was not hospitalized, just stayed at the clinic located in the hospital for a few hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210958723.; Sender's Comments: V0: 20210958772-COVID-19 VACCINE AD26.COV2.S-Confirmed covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 50 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 (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry:21-SEP-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958564, 20210958534, 20210958570 and 20210959706.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 52 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 (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958348, 20210958425, 20210958525, 20210958566, 20210958518, 20210959351, 20210959620, 20210958977, 20210959581, 20210958371 and 20210959909. This case, from the Others is linked to 20210958405.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist 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 (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-20201) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958321, 20210958423, 20210958716, 20210958502, 20210958405, 20210958366, 20210958249, 20210958993.  .
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyskinesia, Gait inability, Headache, Hypokinesia
Clinical narrative: COULD NOT CONTROL HANDS OR FEET, HANDS WERE FORMING A FIST (NAILS INTO PALMS); COULD NOT MOVE HANDS OR FEET; COULD NOT WALK; TINGLING OF EXTREMITIES (UP TO KNEE, ARMS, FEET AND HAND) AND UPPER LIP AREA; NAUSEOUS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. Patient had no history of drug abuse or illicit drug usage. Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced nauseous. On 27-SEP-2021, the patient experienced fever. On 27-SEP-2021, the patient experienced headache. On 28-SEP-2021, the patient experienced could not control hands or feet, hands were forming a fist (nails into palms). On 28-SEP-2021, the patient experienced could not move hands or feet. On 28-SEP-2021, the patient experienced could not walk. On 28-SEP-2021, the patient experienced tingling of extremities (up to knee, arms, feet and hand) and upper lip area. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nauseous, fever, headache, could not control hands or feet, hands were forming a fist (nails into palms), tingling of extremities (up to knee, arms, feet and hand) and upper lip area, could not walk, and could not move hands or feet. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Pyrexia
Clinical narrative: COULD NOT CONTROL HANDS OR FEET, HANDS WERE FORMING A FIST (NAILS INTO PALMS); COULD NOT MOVE HANDS OR FEET; COULD NOT WALK; TINGLING OF EXTREMITIES (UP TO KNEE, ARMS, FEET AND HAND) AND UPPER LIP AREA; NAUSEOUS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. Patient had no history of drug abuse or illicit drug usage. Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced nauseous. On 27-SEP-2021, the patient experienced fever. On 27-SEP-2021, the patient experienced headache. On 28-SEP-2021, the patient experienced could not control hands or feet, hands were forming a fist (nails into palms). On 28-SEP-2021, the patient experienced could not move hands or feet. On 28-SEP-2021, the patient experienced could not walk. On 28-SEP-2021, the patient experienced tingling of extremities (up to knee, arms, feet and hand) and upper lip area. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nauseous, fever, headache, could not control hands or feet, hands were forming a fist (nails into palms), tingling of extremities (up to knee, arms, feet and hand) and upper lip area, could not walk, and could not move hands or feet. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 38 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, and expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient 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 20210958566, 20210959351, 20210958518, 20210959620, 20210958321, 20210958806, 20210958425, 20210959581, 20210958371 and 20210958525.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 62 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, and expiry: 21-SEP-2021) dose was not reported, administered on 29-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958321, 20210958423, 20210958716, 20210958502, 20210958405, 20210958366, 20210958249, 20210958892 and 20210959620.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anisomastia, Joint swelling, Peripheral swelling, Pruritus, Skin disorder
Clinical narrative: SKIN DISORDER; SWOLLEN LEFT LEGS; ANKLE SWELLING; LEFT BREAST WAS BIGGER THAN IT WAS BEFORE; LEFT ARM SWOLLEN; ITCHY SPOTS ON HEAD; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, and other pre-existing medical conditions included: The patient had no known allergies and relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (subcutaneous, batch number: 1152570, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced skin disorder, swollen left legs, ankle swelling, left breast was bigger than it was before, left arm swollen, and itchy spots on head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient recovered from skin disorder on JUL-2021, and swollen left legs, and ankle swelling on 26-JUL-2021, had not recovered from left arm swollen, and itchy spots on head, and the outcome of left breast was bigger than it was before was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: NOT FEELING WELL; SEVERE HEADACHE; FEVER; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced not feeling well, severe headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, fever, and not feeling well. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 29 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient 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. This case, from the same reporter is linked to 20210958348, 20210958371, 20210958425, 20210958518, 20210958566, 20210958806, 20210958321, 20210958525, 20210958977, 20210959581, 20210959620 and 20210959909. This case, from the Others is linked to 20210958423.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: EARS PLUGGED UP, NOT ALL THE TIME BUT MORE THAN NORMAL (AROUND 3 TIMES A WEEK); 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: bad hearing. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21, expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the patient experienced ears plugged up, not all the time but more than normal (around 3 times a week). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ears plugged up, not all the time but more than normal (around 3 times a week). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Tremor
Clinical narrative: SHAKING; OVERBEARING HEAT; CHILLS VERY BAD FOR A FEW HOURS AT NIGHT; 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, 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 patient experienced shaking, overbearing heat, and chills very bad for a few hours at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills very bad for a few hours at night, and the outcome of shaking and overbearing heat was not reported. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED  VACCINE; This spontaneous report received from a health care professional concerned a 38 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: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210959351, 20210959620, 20210958348, 20210958371, 20210958425, 20210958566, 20210958518, 20210958977, 20210958321, 20210958806 and 20210959909.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 45 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: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient 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. This case, from the same reporter is linked to 20210958534, 20210958564, 20210958570 and 20210958784.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 25 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958366, 20210958321 and 20210958423.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSELY AFFECTED BY THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adversely affected by the janssen covid-19 vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of adversely affected by the janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210958633.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: minimal discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (minimal discomfort) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (minimal discomfort). At the time of the report, DISCOMFORT (minimal discomfort) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-335308, MOD-2021-329830 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Cardiac discomfort, Oxygen saturation abnormal, Somnolence
Clinical narrative: blood pressure  been low; Oxygen up and down; She sets down and falls off to sleep; I am having my heart situation looked into as well as my wife; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (blood pressure  been low), OXYGEN SATURATION ABNORMAL (Oxygen up and down), SOMNOLENCE (She sets down and falls off to sleep) and CARDIAC DISCOMFORT (I am having my heart situation looked into as well as my wife) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (blood pressure  been low), OXYGEN SATURATION ABNORMAL (Oxygen up and down), SOMNOLENCE (She sets down and falls off to sleep) and CARDIAC DISCOMFORT (I am having my heart situation looked into as well as my wife). At the time of the report, BLOOD PRESSURE DECREASED (blood pressure  been low), OXYGEN SATURATION ABNORMAL (Oxygen up and down), SOMNOLENCE (She sets down and falls off to sleep) and CARDIAC DISCOMFORT (I am having my heart situation looked into as well as my wife) outcome was unknown.            Concomitant medications were not reported. Treatment information was not provided.  Reporter reported that the patient had not much problem with the first shot.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up received on 22-Sep-2021 contains new event (Cardiac discomfort) was updated. Reporter email and contact details were updated and patient gender updated as per narrative.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site mass, Rash, Throat irritation
Clinical narrative: scratchy throat; felt lightheaded; rash flare up to a medication which stopped after the vaccine.; big knot on arm near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (scratchy throat), DIZZINESS (felt lightheaded), RASH (rash flare up to a medication which stopped after the vaccine.) and INJECTION SITE MASS (big knot on arm near the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (scratchy throat), DIZZINESS (felt lightheaded), RASH (rash flare up to a medication which stopped after the vaccine.) and INJECTION SITE MASS (big knot on arm near the injection site). At the time of the report, THROAT IRRITATION (scratchy throat) and DIZZINESS (felt lightheaded) outcome was unknown and RASH (rash flare up to a medication which stopped after the vaccine.) and INJECTION SITE MASS (big knot on arm near the injection site) had resolved.            Consumer states it also opened up her sinuses where she could smell better. consumer reports that she felt lightheaded after 2nd dose of the vaccine  No concomitant medication reported.  No treatment medication reported.   This case was linked to MOD-2021-272980 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Sig- Follow Up received-TCR--Events outcome was updated.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19 on Wednesday (04Aug2021); Lack of drug effect; Low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19 on Wednesday (04Aug2021)), PYREXIA (Low-grade fever) and DRUG INEFFECTIVE (Lack of drug effect) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (Low-grade fever). On 04-Aug-2021, the patient experienced COVID-19 (Tested positive for Covid-19 on Wednesday (04Aug2021)) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for Covid-19 on Wednesday (04Aug2021)), PYREXIA (Low-grade fever) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19.         Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up received and lack of drug effect added as per latest guidelines and outcome of COVID-19  updated.; Sender's Comments: This case concerns a 48 year-old, male with no relevant medical history , who experienced the unexpected events of COVID19, DRUG INEFFECTIVE . The event occurred approximately 3 month and 23 days after the most recent dose (second dose) of mRNA-1273 Moderna vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Kind of did not feel right after the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Kind of did not feel right after the first vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Brain injury. Concurrent medical conditions included Allergy (Allergic to an injection during surgery about 50 years ago.) and Hypertension. Concomitant products included OXYCODONE for Pain, DICLOFENAC SODIUM, LOSARTAN POTASSIUM, AMLODIPINE, ATORVASTATIN and GABAPENTIN for an unknown indication, NAPROXEN.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION COMPLICATION (Kind of did not feel right after the first vaccine). On 13-Mar-2021, VACCINATION COMPLICATION (Kind of did not feel right after the first vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication include Prenatal vitamin + iron Treatment information was not provided.   This case was linked to MOD-2021-281253 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Added, patient DOB and concomitant medication
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Heart rate, Pain, Palpitations
Clinical narrative: Heart was beating so fast as they were lying down they could almost here it pounding; Pain was irradiating from the shoulder to their breast; Terrible shoulder pain / pain was sharp and deep bellow the tissue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart was beating so fast as they were lying down they could almost here it pounding), PAIN (Pain was irradiating from the shoulder to their breast) and ARTHRALGIA (Terrible shoulder pain / pain was sharp and deep bellow the tissue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included IBUPROFEN for an unknown indication.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PAIN (Pain was irradiating from the shoulder to their breast) and ARTHRALGIA (Terrible shoulder pain / pain was sharp and deep bellow the tissue). On 04-Aug-2021, the patient experienced PALPITATIONS (Heart was beating so fast as they were lying down they could almost here it pounding). On 05-Aug-2021, PAIN (Pain was irradiating from the shoulder to their breast) and ARTHRALGIA (Terrible shoulder pain / pain was sharp and deep bellow the tissue) had resolved. At the time of the report, PALPITATIONS (Heart was beating so fast as they were lying down they could almost here it pounding) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, Heart rate: 100 heart beats per minute (High) around 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Some swelling by my elbow; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Some swelling by my elbow) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Some swelling by my elbow). At the time of the report, JOINT SWELLING (Some swelling by my elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Renal cancer, Thyroid cancer
Clinical narrative: Kidney cancer; Thyroid cancer; This spontaneous case was reported by a consumer and describes the occurrence of RENAL CANCER (Kidney cancer) and THYROID CANCER (Thyroid cancer) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012A21A) for COVID-19 vaccination.   No Medical History information was reported.  On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced THYROID CANCER (Thyroid cancer) (seriousness criterion medically significant). In August 2021, the patient experienced RENAL CANCER (Kidney cancer) (seriousness criterion medically significant). At the time of the report, RENAL CANCER (Kidney cancer) and THYROID CANCER (Thyroid cancer) outcome was unknown.  The patient was diagnosed with kidney cancer a month ago. Patient also recently had stents placed in heart . Patient was currently not receiving cancer treatment because of the stents.  No concomitant medication information provided.  company comment: This case concerns a 71-year-old, female patient with no relevant medical history, who experienced the unexpected events of Thyroid and kidney cancer.. The event Thyroid cancer occurred same month (unspecified date) after the first dose of Moderna Covid-19 vaccine, and the event kidney cancer occurred around 5 months after second dose. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 71-year-old, female patient with no relevant medical history, who experienced the unexpected events of Thyroid and kidney cancer.. The event Thyroid cancer occurred same month (unspecified date) after the first dose of Moderna Covid-19 vaccine, and the event kidney cancer occurred around 5 months after second dose. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.