chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Paranasal sinus discomfort, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SINUS PRESSURE; This solicited report received from a patient: concerned a 40 year old female of unspecified race and ethnic origin. The patient's height and weight were not reported. The patient received flu vaccine around October 2021. It was unknown if the patient had any drug abuse or illicit drug usage, consumed alcohol or smoked. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered in MAY-2021 for prophylactic vaccination. Dose number in series 1. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was negative a week ago and went into quarantine. She was residing in a 2-bedroom apartment with 3 other gentlemen from a neighboring shelter who all tested positive. Only the gentleman she roomed with had complete Moderna vaccine (Moderna) and booster and still tested positive. On 27-NOV-2021 (Saturday night), she had chills and fever which subsided by Sunday (28-NOV-2021). On 28-NOV-2021 (Sunday night), she started getting sinus pressure. On 29-NOV-2021 (Monday), she experienced drainage and cough. On 30-NOV-2021 (Tuesday), she lost smell and tested positive (confirmed covid-19 infection and confirmed clinical vaccination failure). She mentioned that she was fully functional and felt like it was a very minor sniffle cold. Laboratory data included: COVID-19 virus test (NR: not provided) positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, confirmed clinical vaccination failure and sinus pressure was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and confirmed clinical vaccination failure, confirmed covid-19 infection, and sinus pressure was not related. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000205012.; Sender's Comments: V0: 20211203852- covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; BREAKTHROUGH COVID-19; This spontaneous report received from a patient concerned a 56 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: 202A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-APR-2021 to left arm for prophylactic vaccination. (Dose number in series 1). No concomitant medications were reported. On 27-NOV-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive.  On an unspecified date, It was reported that, the patient experienced (fever, cough, congestion, yesterday lost sense of smell and taste) breakthrough covid-19, and confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough covid-19 and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint 90000205216.; Sender's Comments: V0: 20211206786-COVID-19 VACCINE AD26.COV2.S- confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Deep vein thrombosis, Fibrin D dimer
Clinical narrative: THREE DEEP VEIN THROMBOSIS (DVT) LEFT LEG; BLOOD PRESSURE WENT UP; This spontaneous report received from a consumer via a company representative via a social media concerned a 92-year-old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had a blood clot in life. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total 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, after vaccination it was reported that the D-dimer level went up and later had three deep vein thrombosis (DVT) diagnosed in left leg. On an unspecified date, patient's blood pressure went up also.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the three deep vein thrombosis (DVT) left leg and blood pressure went up was not reported. This report was serious (Other Medically Important Condition). This case, from the Others is linked to 20211152736.; Sender's Comments: V0: 20211207894-COVID-19 VACCINE AD26.COV2.S-three deep vein thrombosis (DVT) left leg. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Sensory disturbance
Clinical narrative: FELT LIKE PUSHING ON A NERVE; FELT LIKE A BULLET WENT THROUGH ARM FROM BEING SO COLD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, series 1 administered on 01-DEC-2021 15:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-DEC-2021, the patient experienced felt like pushing on a nerve. On 01-DEC-2021, the patient experienced felt like a bullet went through arm from being so cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like a bullet went through arm from being so cold and felt like pushing on a nerve was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INAPPROPRIATELY STORED VACCINE ADMINISTERED; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the patient experienced out of specification product use. On an unspecified date, the patient experienced inappropriately stored vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriately stored vaccine administered and out of specification product use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Anxiety, Cough, Hypophagia, Malaise
Clinical narrative: ANXIOUS; TEARFUL; COUGH; NOT FEELING WELL; UNUSUAL SIDE EFFECTS; HAVE NOT EATEN SINCE MONDAY; 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 was not reported, administered on 29-NOV-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 29-NOV-2021, the patient experienced unusual side effects. On 29-NOV-2021, the patient experienced have not eaten since monday. On 29-NOV-2021, the patient experienced not feeling well. On an unspecified date, the patient experienced anxious, tearful, and cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling well, unusual side effects, have not eaten since monday, anxious, cough and tearful was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tearfulness
Clinical narrative: ANXIOUS; TEARFUL; COUGH; NOT FEELING WELL; UNUSUAL SIDE EFFECTS; HAVE NOT EATEN SINCE MONDAY; 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 was not reported, administered on 29-NOV-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 29-NOV-2021, the patient experienced unusual side effects. On 29-NOV-2021, the patient experienced have not eaten since monday. On 29-NOV-2021, the patient experienced not feeling well. On an unspecified date, the patient experienced anxious, tearful, and cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling well, unusual side effects, have not eaten since monday, anxious, cough and tearful was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. No past medical history or no concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: UNKNOWN) dose was not reported (dose series:1), 1 total administered on MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient started experiencing sore throat, congestion, a little bit of body ache, chills and a little fatigue. The patient took Covid test (COVID-19 virus test) and result was found to be positive (confirmed clinical vaccination failure and confirmed covid-19 infection). On 02-DEC-2021, the patient had a little bit of body ache and fatigue. The patient denied any covid exposure. The patient was not pregnant at the time of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed clinical vaccination failure, and confirmed covid-19 infection. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000205186.; Sender's Comments: V0: 20211209731-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: LITTLE DISCOMFORT; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced phenergan allergy when treated with promethazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: 23-AUG-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced little discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little discomfort. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: THE INDIVIDUAL RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS THE INITIAL DOSE (APPROXIMATELY AROUND 0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 33 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: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced the individual received less than 0.5ml of the janssen covid-19 vaccine as the initial dose (approximately around 0.3ml). On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received less than 0.5ml of the janssen covid-19 vaccine as the initial dose (approximately around 0.3ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211210160, 20211210058, 20211209551 and 20211209843.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DEEP VEIN THROMBOSIS IN RIGHT LEG; This spontaneous report received from a patient concerned a 57 year old. The patient's height, and weight were not reported. The patient's past medical history included: right leg damage about 35 years ago, and concurrent conditions included: got cellulitis sometimes and somewhat compromised vascularly. The patient received covid-19 vaccine ad26.cov2.s (Series 1) (suspension for injection, route of administration not reported, batch number: 1805022, and expiry: 23-AUG-2021) dose was not reported, 01 total, administered in left deltoid on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. It was reported that, the patient started noticing leg swelling in APR-2021 which did not bothered him much. In JUN-2021, he went to a doctor and was diagnosed with blood clots in right leg (deep vein thrombosis) and was put on unspecified blood thinners. He was still taking maintenance Aspirin (acetylsalicylic acid) and was on Xarelto (rivaroxaban) initially for 6 weeks. Doctor said it looks ok now. The patient suspected it might have been the vaccine. No arm pain or any other side effects was reported by patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from deep vein thrombosis in right leg. This report was serious (Other Medically Important Condition).; Sender's Comments:- 20211209916-Covid-19 vaccine ad26.CoV-2.s- Deep vein thrombosis in right leg. This event is considered unassessable. The event 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.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: PATIENT UNDERDOSED AND RECEIVED 0.3ML; OFF LABEL USE; This spontaneous report received from a health care professional 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: 2132D21A, and  expiry: UNKNOWN) .3 ml, administered on 03-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-DEC-2021, the patient experienced patient underdosed and received 0.3ml. On 03-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient underdosed and received 0.3ml and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211209999.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: UNDERDOSED AND RECEIVED 0.3ML OF VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional 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: 2132D21A, expiry: UNKNOWN) dose was not reported, administered on 03-DEC-2021 for prophylactic vaccination (Dose series number : 1). No concomitant medications were reported. On 03-DEC-2021, the patient experienced underdosed and received 0.3ml of vaccine. On 03-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the underdosed and received 0.3ml of vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211209986.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: THE INDIVIDUAL RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS THE INITIAL DOSE (APPROXIMATELY AROUND 0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 35 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: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced the individual received less than 0.5ml of the janssen covid-19 vaccine as the initial dose (approximately around 0.3ml). On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received less than 0.5ml of the janssen covid-19 vaccine as the initial dose (approximately around 0.3ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211210067, 20211209551, 20211210058 and 20211210160.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: THE INDIVIDUAL RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS THE INITIAL DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 59 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: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced the individual received less than 0.5ml of the janssen covid-19 vaccine as the initial dose. On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received less than 0.5ml of the janssen covid-19 vaccine as the initial dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211209679, 20211209706, 20211209740, 20211209775, 20211209782, 20211209816, 20211209843, 20211209874, 20211209880, 20211209884, 20211209912, 20211209921, 20211210019, 20211210058, 20211210067, 20211210106, 20211210107, 20211210112, 20211210141, 20211210143, 20211210159, 20211210165, 20211210180, 20211210350, 20211210385, 20211210408, 20211210549, 20211210555, 20211210585, 20211210588, 20211210610, 20211210662, 20211210670, 20211210733, 20211210824, 20211212082, 20211212088, 20211209551, 20211209976, 20211209551, 20211210409, 20211209798, 20211209976, 20211210160, 20211210590 and 20211210334.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: LITTLE BIT SICK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced little bit sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little bit sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211212233.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure congestive
Clinical narrative: CONGESTIVE HEART FAILURE; This spontaneous report received from a consumer via a company representative via media concerned a patient of unspecified age, sex, race, and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, with frequency time 1 total for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter reported that, "one person went into congestive heart failure." The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of congestive heart failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211205693 and 20211210341.; Sender's Comments: V0: 20211210328-covid-19 vaccine ad26.cov2.s-congestive heart  failure. 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: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: THE INDIVIDUAL RECEIVED LESS THAN 0.5 ML OF THE JNJ VACCINE AS THE INITIAL DOSE (APPROXIMATELY AROUND 0.3 ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 69 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: 213D21A, expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced the individual received less than 0.5 ml of the JNJ vaccine as the initial dose (approximately around 0.3 ml). On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received less than 0.5 ml of the JNJ vaccine as the initial dose (approximately around 0.3 ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210112 and 20211210197.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: HEART FAILURE; This spontaneous report received from a consumer via social media concerned multiple patients of unspecified sex, race and ethnicity. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (vaccine dose series was 1) (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, two patients died from heart failure. It was unknown an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211210328 and 20211205693.; Sender's Comments: V0: 20211210341- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Heart failure (Fatal outcome). This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART FAILURE
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: POTENTIAL ADMINISTRATION OF EXPIRED VACCINE; 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: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 15-OCT-2021 for prophylactic vaccination (Dose series number : 1). No concomitant medications were reported. On 15-OCT-2021, the patient experienced potential administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential administration of expired vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: HIGH FEVER; UNRELENTING HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 high fever, and unrelenting headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever and unrelenting headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: GOT SICK FOR A BIT; 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. The patient's concurrent conditions included: immune compromised. 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. 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 got sick for a bit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got sick for a bit was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Underdose
Clinical narrative: RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS THE INITIAL DOSE, APPROXIMATELY AROUND 0.3ML; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 37 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: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced received less than 0.5ml of the janssen covid-19 vaccine as the initial dose, approximately around 0.3ml. On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml of the janssen covid-19 vaccine as the initial dose, approximately around 0.3ml and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211209679, 20211209706, 20211209884, 20211209912, 20211209921, 20211209976, 20211210019, 20211210733, 20211210824, 20211212082, 20211212088, 20211210588, 20211210112, 20211209775, 20211210610, 20211210409, 20211210555 and 20211210408.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: DERMA WART WENT AWAY; This spontaneous report received from a patient via a company representative concerned a 62 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included: derma wart, and other pre-existing medical conditions included: The patient had used different unspecified topical creams over many years. 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 MAR-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 derma wart went away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of derma wart went away was not reported. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: RECEIVED LESS THAN 0.5 ML OF THE JANSSEN  COVID-19 VACCINE AS A INITIAL DOSE (0.3 ML); This spontaneous report received from a health care professional concerned a 44 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: 213D21A, expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced received less than 0.5 ml of the janssen covid-19 vaccine as a initial dose (0.3 ml). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received less than 0.5 ml of the janssen covid-19 vaccine as a initial dose (0.3 ml) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211209551, 20211209679, 20211209706, 20211209740, 20211209775, 20211209782, 20211209798, 20211209816, 20211209843, 20211209874, 20211209880, 20211209884, 20211209912, 20211210019, 20211210058, 20211209976, 20211209921, 20211210160, 20211210610, 20211210733 and 20211210409.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: MILD SORENESS IN ARM; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 number. No concomitant medications were reported.  On an unspecified date, the patient experienced mild soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild soreness in arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210219 and 20211210428.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, the patient experienced inappropriate dose of vaccine administered. On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate dose of vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE STORED OUTSIDE OF THE RECOMMENDED CONDITIONS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-DEC-2021, the patient experienced administration of vaccine stored outside of the recommended conditions. On 04-DEC-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine stored outside of the recommended conditions and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Fatigue
Clinical narrative: LOSS OF APPETITE/NOT HUNGRY; SOME COUGHING; FATIGUE/TIRED; This spontaneous report received from a patient concerned an 83 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies, 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced loss of appetite/not hungry. On APR-2021, the patient experienced some coughing. On APR-2021, the patient experienced fatigue/tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite/not hungry, some coughing, and fatigue/tired on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID (3.5 WEEKS) AFTER VACCINATION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 got covid (3.5 weeks) after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid (3.5 weeks) after vaccination was not reported. This report was non-serious. This case, from the same reporter is linked to 20211212581.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Disturbance in attention, Hypoaesthesia, Vertigo
Clinical narrative: VERTIGO; TROUBLE BALANCING; CONCENTRATION LOSS; ARM NUMBNESS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 vertigo, trouble balancing, concentration loss, and arm numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vertigo, arm numbness, trouble balancing, and concentration loss. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nonspecific reaction
Clinical narrative: BAD REACTION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 bad reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: ARM HURT FOR TWO DAYS; HEADACHE THE SECOND DAY AFTER VACCINATION; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). 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 arm hurt for two days, and headache the second day after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt for two days, and the outcome of headache the second day after vaccination was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: REDNESS UNDERNEATH EYES AND CHEEKBONES; SWELLING UNDERNEATH EYES AND CHEEKBONES; ITCHY; RASH ON NECK/ARM/DIFFERENT PARTS OF THE BODY; This spontaneous report received from a physician concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high cholesterol, alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-OCT-2021, the patient experienced rash on neck/arm/different parts of the body. On 05-DEC-2021, the patient experienced redness underneath eyes and cheekbones. On 05-DEC-2021, the patient experienced swelling underneath eyes and cheekbones. On 05-DEC-2021, the patient experienced itchy. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on neck/arm/different parts of the body, redness underneath eyes and cheekbones, itchy, and swelling underneath eyes and cheekbones. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: SEVERE SEIZURES; This spontaneous report received from a parent concerned a female of unspecified age, race and ethnicity The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient had no history of seizures. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total (Dose number in series 1), 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 parent stated "My daughter had seizures after Covid vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe seizures was unknown. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211212465-covid-19 vaccine ad26.cov2.s-severe seizures. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: SLIGHT BODY ACHES; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 slight body aches, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight body aches, headache and fatigue was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: ARM PAIN THAT SHE RECEIVED THE VACCINE, PAIN WAS TERRIBLE AND RADIATES TO THE SHOULDER (UP TO THE NECK) AND IT'S MUSCLE; MUSCLE ON THE ARM GOT HOT; This spontaneous report received from a patient concerned a 79 year old female. 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: 076C21A, and expiry: UNKNOWN) dose was not reported, administered on 26-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced muscle on the arm got hot. On 11-NOV-2021, the patient experienced arm pain that she received the vaccine, pain was terrible and radiates to the shoulder (up to the neck) and it's muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain that she received the vaccine, pain was terrible and radiates to the shoulder (up to the neck) and it's muscle, and the outcome of muscle on the arm got hot was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID AFTER VACCINATION; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the patient experienced covid after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid after vaccination was not reported. This report was non-serious. This case, from the same reporter is linked to 20211212211.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vomiting
Clinical narrative: VOMITING; TIREDNESS; 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: high blood pressure, gi problems, hypothyroidism, anxiety, non smoker, and abstains from alcohol, and other pre-existing medical conditions included: The patient had no known drug allergy and no history of illicit drug use/abuse. The patient was previously treated with paracetamol for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included mirtazapine for anxiety, omeprazole for gi problems, enalapril maleate for high blood pressure, and levothyroxine sodium for hypothyroidism. On 12-MAR-2021, the patient experienced tiredness. On 16-MAR-2021, the patient experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 16-MAR-2021, and tiredness on 15-MAR-2021. This report was non-serious.