chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Insomnia, Nail ridging, Pain, Pruritus
Clinical narrative: BODY PAIN; UNABLE TO SLEEP FOR 3 DAYS; ITCH OVER 100% OF BODY; BEAU'S LINES; FEVER OF 103.3; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 subject experienced body pain, unable to sleep for 3 days, itch over 100% of body, beau's lines, and fever of 103.3. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.3 (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 103.3, body pain, unable to sleep for 3 days, itch over 100% of body and beau's lines was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY PAIN; UNABLE TO SLEEP FOR 3 DAYS; ITCH OVER 100% OF BODY; BEAU'S LINES; FEVER OF 103.3; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 subject experienced body pain, unable to sleep for 3 days, itch over 100% of body, beau's lines, and fever of 103.3. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.3 (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 103.3, body pain, unable to sleep for 3 days, itch over 100% of body and beau's lines was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: MAGNET STICKING TO VACCINATION SITE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAY-2021, the subject experienced magnet sticking to vaccination site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of magnet sticking to vaccination site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210555852.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Feeling abnormal, Headache
Clinical narrative: BODY ACHE; FEEL AWFUL; CHILLS; HEADACHE; BODY TEMPERATURE (101.0 TEMPERATURE); 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. 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 ache, feel awful, chills, headache, and body temperature (101.0 temperature). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.0 temp. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache, chills, headache, feel awful and body temperature (101.0 temperature) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHE; FEEL AWFUL; CHILLS; HEADACHE; BODY TEMPERATURE (101.0 TEMPERATURE); 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. 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 ache, feel awful, chills, headache, and body temperature (101.0 temperature). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.0 temp. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body ache, chills, headache, feel awful and body temperature (101.0 temperature) was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling cold, Headache, Myalgia
Clinical narrative: FREEZING; BODY ACHES; MUSCLE ACHES; FEVER (FELT FACE WARM); HEADACHE; FELT FATIGUED; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 155 pounds, and height was 66 inches. The patient's concurrent conditions included social drinker, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and did not have alcohol (on the day of vaccination).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-MAY-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced felt fatigued. On 28-MAY-2021, the subject experienced freezing. On 28-MAY-2021, the subject experienced body aches. On 28-MAY-2021, the subject experienced muscle aches. On 28-MAY-2021, the subject experienced fever (felt face warm). On 28-MAY-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt fatigued, headache, fever (felt face warm), freezing, and muscle aches, and the outcome of body aches was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: FREEZING; BODY ACHES; MUSCLE ACHES; FEVER (FELT FACE WARM); HEADACHE; FELT FATIGUED; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 155 pounds, and height was 66 inches. The patient's concurrent conditions included social drinker, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and did not have alcohol (on the day of vaccination).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-MAY-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced felt fatigued. On 28-MAY-2021, the subject experienced freezing. On 28-MAY-2021, the subject experienced body aches. On 28-MAY-2021, the subject experienced muscle aches. On 28-MAY-2021, the subject experienced fever (felt face warm). On 28-MAY-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt fatigued, headache, fever (felt face warm), freezing, and muscle aches, and the outcome of body aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: BODY ACHES; COLD CHILLS; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 aches, cold chills, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold chills, body aches and tiredness was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: WEAKNESS; This spontaneous report received from a consumer concerned a 52 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, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weakness on 12-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210556156, 20210556420 and 20210556823.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Secretion discharge
Clinical narrative: MUCUS; FEVER (FLU LIKE SYMPTOMS SUBSUMED); This spontaneous report received from a consumer concerned a 21 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 MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAY-2021, the subject experienced mucus. On MAY-2021, the subject experienced fever (flu like symptoms subsumed). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mucus, and fever (flu like symptoms subsumed) on MAY-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED SERIOUS REACTION DUE TO WHICH PATIENT STILL WAS ON A VENTILATOR; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age via social media. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced unspecified serious reaction. The patient was hospitalized on unspecified date and still was on a ventilator due to unspecified serious reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unspecified serious reaction due to which patient still was on a ventilator. This report was serious (Life Threatening).; Sender's Comments: V0 - 20210556136-covid-19 vaccine ad26.cov2.s-Unspecified serious reaction due to which patient still was on a ventilator 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: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: MILD PAIN IN THE AREA OF APPLICATION; This spontaneous report received from a consumer concerned a 38 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: 204A21A expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the subject experienced mild pain in the area of application. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild pain in the area of application was not reported. This report was non-serious. This case, from the same reporter is linked to 20210556038.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered
Clinical narrative: ADMINISTRATION OF POTENTIALLY EXPIRED VACCINE; VIAL WAS OPENED  AT 9.35AM AND THE VACCINE WAS ADMINISTERED AT 6.50PM (AFTER 6 HOURS OF OPENING); This spontaneous report received from a health care professional concerned a 35 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: 1820095, and batch number: 1820095 expiry: 04-JUL-2021) dose was not reported, administered on 27-MAY-2021 18:50 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced administration of potentially expired vaccine. On 27-MAY-2021, the subject experienced vial was opened at 9.35am and the vaccine was administered at 6.50pm (after 6 hours of opening). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of potentially expired vaccine and vial was opened at 9.35am and the vaccine was administered at 6.50pm (after 6 hours of opening) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: ADMINISTRATION ERROR OF A VACCINE SYRINGE AFTER 2.5 HOURS; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced administration error of a vaccine syringe after 2.5 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration error of a vaccine syringe after 2.5 hours was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: DOUBLE DOSE RECEIVED; This spontaneous report received from a pharmacist concerned a 53 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: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-MAR-2021, and dose was not reported. The batch number was not reported and has been requested, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-MAY-2021, the subject experienced double dose received. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of double dose received was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Chills, Pyrexia, Tremor
Clinical narrative: SHAKING; CHILLS; FEVER; ABDOMINAL PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 29 year old female. The patient's weight was 130 pounds, and height was 65 inches. The patient's past medical history included mostly just injuries, and concurrent conditions included non alcoholic, cigarette smoker, and drug abuse-marijuana, and other pre-existing medical conditions included the patient has no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced abdominal pain. On MAY-2021, the subject experienced back pain. On 25-MAY-2021, the subject experienced shaking. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, shaking, abdominal pain and back pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: HOSPITALIZATION FOR ADVERSE  EVENT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date patient got Unspecified adverse event due to covid-19 vaccine shot which resulted to hospitalization. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalization for adverse event was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210556296-covid-19 vaccine ad26.cov2.s-Hospitalization for adverse event. 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Chills, Gait inability, Headache, Myalgia
Clinical narrative: This spontaneous report received from a patient 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced inflamed joints below legs. On 22-MAY-2021, the subject experienced can't walk. On 22-MAY-2021, the subject experienced chills. On 22-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced fever. On 22-MAY-2021, the subject experienced nausea. On 22-MAY-2021, the subject experienced severe muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and nausea on 24-MAY-2021, was recovering from fever, had not recovered from inflamed joints below legs, and severe muscle soreness, and the outcome of can't walk was not reported. This report was non-serious.; Sender's Comments: V0:MAC not required as per standard procedure as case was assessed as non- serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous report received from a patient 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced inflamed joints below legs. On 22-MAY-2021, the subject experienced can't walk. On 22-MAY-2021, the subject experienced chills. On 22-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced fever. On 22-MAY-2021, the subject experienced nausea. On 22-MAY-2021, the subject experienced severe muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and nausea on 24-MAY-2021, was recovering from fever, had not recovered from inflamed joints below legs, and severe muscle soreness, and the outcome of can't walk was not reported. This report was non-serious.; Sender's Comments: V0:MAC not required as per standard procedure as case was assessed as non- serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: MILD PAIN IN THE AREA OF APPLICATION; This spontaneous report received from a consumer concerned a 29 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: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced mild pain in the area of application. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild pain in the area of application was not reported. This report was non-serious. This case, from the same reporter is linked to 20210556156 and 20210556038.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On 23-MAY-2021, the patient did not develop the antibodies (patient experienced confirmed immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210556475-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Musculoskeletal pain, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: TINGLING IN LEFT ARM AND FINGERS TINGLE; HAD ME IN BED WITH FLU LIKE SYMPTOMS FOR ABOUT 36 HOURS; VACCINE DID KICK MY BUTT; SHARP PAIN RADIATES DOWN ARM; PAIN IN THE MUSCLE LEADING FROM MY ELBOW TO MY FINGERS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced tingling in left arm and fingers tingle. On MAY-2021, the subject experienced had me in bed with flu like symptoms for about 36 hours. On MAY-2021, the subject experienced vaccine did kick my backside. On MAY-2021, the subject experienced sharp pain radiates down arm. On MAY-2021, the subject experienced pain in the muscle leading from my elbow to my fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling in left arm and fingers tingle, pain in the muscle leading from my elbow to my fingers, sharp pain radiates down arm, vaccine did kick my backside, and had me in bed with flu like symptoms for about 36 hours. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: MISHANDLED JANSSEN COVID-19 ADMINISTERED TO A CONSUMER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 mishandled janssen covid-19 administered to a consumer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mishandled janssen covid-19 administered to a consumer was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: VACCINATED WITH JANSSEN COVID-19  VACCINE WHICH WAS LEFT OUTSIDE  IN ROOM TEMPERATURE MORE THAN  2 HOURS; INCORRECT STORAGE OF VACCINE; This spontaneous report received from a pharmacist concerned a 31 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: 1821281, and batch number: 1821281 expiry: 23-JUL-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAY-2021, the subject experienced vaccinated with janssen covid-19 vaccine which was left outside in room temperature more than 2 hours. On 27-MAY-2021, the subject experienced incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccinated with janssen covid-19 vaccine which was left outside in room temperature more than 2 hours and incorrect storage of vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210556814 and 20210556611.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot, Headache, Hyperhidrosis, Pain
Clinical narrative: SKIN FELT HOT TO TOUCH; SWELLING OF THROAT; SWEATING; BODY ACHES (UPPER CHEST, BACK AND LEFT HIP AREA); FELT FREEZE COLD; HEADACHE IN OCCIPITAL LOBE; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight was 168 pounds, and height was 60 inches. The patient's concurrent conditions included post traumatic stress disorder, social anxiety, avoidant personality, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 294A21A, expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On 28-MAY-2021, the subject experienced skin felt hot to touch. On 28-MAY-2021, the subject experienced swelling of throat. On 28-MAY-2021, the subject experienced sweating. On 28-MAY-2021, the subject experienced body aches (upper chest, back and left hip area). On 28-MAY-2021, the subject experienced felt freeze cold. On 28-MAY-2021, the subject experienced headache in occipital lobe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating, and had not recovered from felt freeze cold, skin felt hot to touch, swelling of throat, headache in occipital lobe, and body aches (upper chest, back and left hip area). This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, SARS-CoV-2 test
Clinical narrative: SKIN FELT HOT TO TOUCH; SWELLING OF THROAT; SWEATING; BODY ACHES (UPPER CHEST, BACK AND LEFT HIP AREA); FELT FREEZE COLD; HEADACHE IN OCCIPITAL LOBE; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight was 168 pounds, and height was 60 inches. The patient's concurrent conditions included post traumatic stress disorder, social anxiety, avoidant personality, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 294A21A, expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On 28-MAY-2021, the subject experienced skin felt hot to touch. On 28-MAY-2021, the subject experienced swelling of throat. On 28-MAY-2021, the subject experienced sweating. On 28-MAY-2021, the subject experienced body aches (upper chest, back and left hip area). On 28-MAY-2021, the subject experienced felt freeze cold. On 28-MAY-2021, the subject experienced headache in occipital lobe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating, and had not recovered from felt freeze cold, skin felt hot to touch, swelling of throat, headache in occipital lobe, and body aches (upper chest, back and left hip area). This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dry mouth, Dyspnoea, Ear discomfort, Headache
Clinical narrative: HEADACHE; LEFT ARM WAS WEAK AND LEGS WERE WEAK FOR A FEW MINUTES; EARS FELT CLOGGED; FELT A NOISE IN MY EARS; SHORTNESS OF BREATH; COULD NOT BREATHE THROUGH MY NOSE SO BREATHING THROUGH MY MOUTH; CHEST PAIN; NASAL CONGESTION; TOP OF MOUTH DRY AND RASPY; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 132 pounds, and height was 65 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced top of mouth dry and raspy. On 23-MAY-2021, the subject experienced nasal congestion. On 24-MAY-2021, the subject experienced chest pain. On 26-MAY-2021, the subject experienced shortness of breath. On 26-MAY-2021, the subject experienced felt a noise in my ears. On 27-MAY-2021, the subject experienced ears felt clogged. On 28-MAY-2021, the subject experienced left arm was weak and legs were weak for a few minutes. On an unspecified date, the subject experienced could not breathe through my nose so breathing through my mouth, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left arm was weak and legs were weak for a few minutes, was recovering from nasal congestion, top of mouth dry and raspy, and could not breathe through my nose so breathing through my mouth, had not recovered from chest pain, and headache, and the outcome of ears felt clogged, felt a noise in my ears and shortness of breath was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Nasal congestion, Tinnitus
Clinical narrative: HEADACHE; LEFT ARM WAS WEAK AND LEGS WERE WEAK FOR A FEW MINUTES; EARS FELT CLOGGED; FELT A NOISE IN MY EARS; SHORTNESS OF BREATH; COULD NOT BREATHE THROUGH MY NOSE SO BREATHING THROUGH MY MOUTH; CHEST PAIN; NASAL CONGESTION; TOP OF MOUTH DRY AND RASPY; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 132 pounds, and height was 65 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced top of mouth dry and raspy. On 23-MAY-2021, the subject experienced nasal congestion. On 24-MAY-2021, the subject experienced chest pain. On 26-MAY-2021, the subject experienced shortness of breath. On 26-MAY-2021, the subject experienced felt a noise in my ears. On 27-MAY-2021, the subject experienced ears felt clogged. On 28-MAY-2021, the subject experienced left arm was weak and legs were weak for a few minutes. On an unspecified date, the subject experienced could not breathe through my nose so breathing through my mouth, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left arm was weak and legs were weak for a few minutes, was recovering from nasal congestion, top of mouth dry and raspy, and could not breathe through my nose so breathing through my mouth, had not recovered from chest pain, and headache, and the outcome of ears felt clogged, felt a noise in my ears and shortness of breath was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood glucose increased
Clinical narrative: HIGH BLOOD SUGAR; 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 concurrent conditions included diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes. On 28-MAY-2021, the subject experienced high blood sugar. Laboratory data included: Blood sugar abnormal (NR: not provided) 268 mg/dL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood sugar. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Oropharyngeal pain, Pyrexia, Vision blurred
Clinical narrative: SORE THROAT; FEVER OF 104/LOW GRADE FEVER; DIZZINESS; BLURRED VISION; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, high cholesterol, alcohol consume 3 glass per week, and non smoker, and other pre-existing medical conditions included the patient had not known allergies to drug. 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, administered on 21-MAY-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure. On 21-MAY-2021, the patient experienced dizziness. On 21-MAY-2021, the patient experienced blurred vision. On 21-MAY-2021, the patient experienced fever of 104/low grade fever. Laboratory data included: Body temperature (NR: not provided) fever 104. On 23-MAY-2021, the patient experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 104/low grade fever, and had not recovered from dizziness, blurred vision, and sore throat. This report was non-serious
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: BACK PAIN; This spontaneous report received from a patient concerned a 70 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: 30/JUN/2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: RANDOM NOSE BLEED; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient had no known allergy no 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: 207A21A and  expiry: unknown) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-MAY-2021, the subject experienced random nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from random nose bleed on 28-MAY-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company was unable to follow-up request for batch number. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: ACHES FOR ABOUT 2-3 DAYS; AWFUL NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company was unable to follow-up request for batch number. No concomitant medications were reported. On an unspecified date, the subject experienced aches for about 2-3 days, and awful nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the awful nausea and aches for about 2-3 days was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Hypoaesthesia, Paraesthesia, Vertigo
Clinical narrative: NUMBNESS ON LEFT SIDE OF BODY (LEG, ARM AND FACE); PINS AND NEEDLES THROUGHOUT THE BODY (INTERMITTENTLY); DIZZINESS; VERTIGO; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, and other pre-existing medical conditions included no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced vertigo. On 19-MAY-2021, the subject experienced numbness on left side of body (leg, arm and face). On 19-MAY-2021, the subject experienced pins and needles throughout the body (intermittently). On 22-MAY-2021, Laboratory data included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, vertigo, numbness on left side of body (leg, arm and face), and pins and needles throughout the body (intermittently). This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Hypertension, Hypoaesthesia
Clinical narrative: FEET DISCOLORATION (PURPLE/BLUE) WHEN SITTING DOWN; CALVES FELT LIKE GOING TO SLEEP; TINGLING IN FEET; YUCKY AND TOXIC FEELING; NERVOUSNESS; HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; FACIAL PUFFINESS; BAD FEELING (FELT LIKE HIT BY TRUCK); LIGHT HEADEDNESS AND DIZZINESS; PUFFY AND SWOLLEN FEET; HAND PUFFINESS; SORENESS OF ARM; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, alcohol use, and non smoker, and other pre-existing medical conditions included the patient did not had 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure.  On MAR-2021, the subject experienced soreness of arm. On MAR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced hand puffiness. On 09-APR-2021, the subject experienced puffy and swollen feet. On 13-APR-2021, the subject experienced facial puffiness. On 13-APR-2021, the subject experienced bad feeling (felt like hit by truck). On 13-APR-2021, the subject experienced light headedness and dizziness. On 28-APR-2021, the subject experienced high blood pressure. On 28-APR-2021, the subject experienced shortness of breath. On MAY-2021, the subject experienced calves felt like going to sleep. On MAY-2021, the subject experienced tingling in feet. On MAY-2021, the subject experienced yucky and toxic feeling. On MAY-2021, the subject experienced nervousness. On 25-MAY-2021, the subject experienced feet discoloration (purple/blue) when sitting down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from puffy and swollen feet, and feet discoloration (purple/blue) when sitting down, and the outcome of high blood pressure, shortness of breath, flu-like symptoms, soreness of arm, facial puffiness, bad feeling (felt like hit by truck), light headedness and dizziness, hand puffiness, calves felt like going to sleep, tingling in feet, yucky and toxic feeling and nervousness was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Negative thoughts, Nervousness, Pain in extremity, Paraesthesia
Clinical narrative: FEET DISCOLORATION (PURPLE/BLUE) WHEN SITTING DOWN; CALVES FELT LIKE GOING TO SLEEP; TINGLING IN FEET; YUCKY AND TOXIC FEELING; NERVOUSNESS; HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; FACIAL PUFFINESS; BAD FEELING (FELT LIKE HIT BY TRUCK); LIGHT HEADEDNESS AND DIZZINESS; PUFFY AND SWOLLEN FEET; HAND PUFFINESS; SORENESS OF ARM; FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, alcohol use, and non smoker, and other pre-existing medical conditions included the patient did not had 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure.  On MAR-2021, the subject experienced soreness of arm. On MAR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced hand puffiness. On 09-APR-2021, the subject experienced puffy and swollen feet. On 13-APR-2021, the subject experienced facial puffiness. On 13-APR-2021, the subject experienced bad feeling (felt like hit by truck). On 13-APR-2021, the subject experienced light headedness and dizziness. On 28-APR-2021, the subject experienced high blood pressure. On 28-APR-2021, the subject experienced shortness of breath. On MAY-2021, the subject experienced calves felt like going to sleep. On MAY-2021, the subject experienced tingling in feet. On MAY-2021, the subject experienced yucky and toxic feeling. On MAY-2021, the subject experienced nervousness. On 25-MAY-2021, the subject experienced feet discoloration (purple/blue) when sitting down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from puffy and swollen feet, and feet discoloration (purple/blue) when sitting down, and the outcome of high blood pressure, shortness of breath, flu-like symptoms, soreness of arm, facial puffiness, bad feeling (felt like hit by truck), light headedness and dizziness, hand puffiness, calves felt like going to sleep, tingling in feet, yucky and toxic feeling and nervousness was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.