chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: receiving only  the AS01B Adjuvant of Shingrix; receiving only  the AS01B Adjuvant of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   On 30th September 2021, the patient received Shingrix. On 30th September 2021, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional details were reported as follows: A patient receiving today only the AS01B Adjuvant of Shingrix (without the Lyophilized Component) which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose of Shingrix 4 months before 3rd dose).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at the vaccination was not reported. The pharmacist reported that the patient between 60 and 70 years old received by mistake a third dose of Shingrix, which led to extra dose administered. The pharmacist also reported that it had been 4 months between second and third dose of Shingrix. No data about patient´s details or lot number from Shingrix third dose at the moment of the call. The reporter consented to follow up via email.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: some of it leaked onto her arm; some of it leaked onto her arm; inadvertent exposure; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number PG35Z, expiry date 11th March 2023) for prophylaxis.   On 1st October 2021, the patient received the 1st dose of Shingrix. On 1st October 2021, unknown after receiving Shingrix, the patient experienced incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.  Additional details were provided as follows: The pharmacist reported that during administration of Shingrix to the patient some of the vaccine leaked on patient's arm, which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: red marks on body; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2021, the patient received Shingrix. On 8th September 2021, 7 days after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's niece.   The age at vaccination was not reported. The reporter reported that the patient got the Shingrix vaccine and a week later developed red marks on her body. The patient was still experiencing these red marks. It was unknown if this was the first or second dose. The reporter did not consent to follow up. There was no additional information known about this report.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administered expired doses; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number G3Z3N, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported. The nurse reported that they administered Fluarix 2020-2021 expired doses to the patient, which was expired on 30th June 2021, which led to expired vaccine used. The reporter consented to follow up via email. This was 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR207378:same reporter US-GLAXOSMITHKLINE-US2021AMR207379:same reporter US-GLAXOSMITHKLINE-US2021AMR207380:same reporter US-GLAXOSMITHKLINE-US2021AMR207377:same reporter
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered with only the AS01B adjuvant of Shingrix.; administered with only the AS01B adjuvant of Shingrix.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 7C483, expiry date 14th November 2022) for prophylaxis.   On 21st September 2021, the patient received Shingrix. On 21st September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient was administered with only the AS01B adjuvant of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case had been linked to the case US2021206994, US2021206991 and US2021206990, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021206991:same reporter US-GLAXOSMITHKLINE-US2021206994:same reporter US-GLAXOSMITHKLINE-US2021206990:same reporter
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: third dose of Shingrix was administrated; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number z4427, expiry date 31st January 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose in February 2021).   On 4th October 2021, the patient received the 3rd dose of Shingrix. On 4th October 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details provided were as follows: The pharmacist report that a third dose of Shingrix was administrated by error, which led to extra dose administered. The reporter stated the patient came and claimed that he had not received that dose and due to miscommunication between colleagues and the patient did not notified that they had received already a second dose and the health care professional administrated a third dose thinking it was the second dose the patient would be receiving. The third dose was not administrated on the same day as the second dose. No further events were reported. The reporter agreed to be contacted for follow-up.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: vaccine had been exposed to below freezing temperature; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the vaccine had been exposed to below freezing temperature and that a person (patient) might had received a dose after being frozen, which led to incorrect storage of drug. The reporter then mentioned that there was no confirmation that the excursion had happened before the administration so probably no patient had been given an incorrect dose. No more information was available to reporter since this incident had occurred at another location. The reporter did not consent to follow up and could not confirm if a patient was involved or not at the moment of the call.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chest discomfort, Dyspnoea, Heart rate
Clinical narrative: experiencing episodic of atrial fibrillation to sinus beat like 2 to 1 or 3 to 1; Little bit of chest discomfort; shortness of breath; This spontaneous case was reported by a nurse and describes the occurrence of ATRIAL FIBRILLATION (experiencing episodic of atrial fibrillation to sinus beat like 2 to 1 or 3 to 1) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heartbeats irregular in 2017 and Cardiac ablation in 2017. Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (experiencing episodic of atrial fibrillation to sinus beat like 2 to 1 or 3 to 1) (seriousness criterion medically significant). The patient was treated with NAPROXEN (NAPROSYN [NAPROXEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, ATRIAL FIBRILLATION (experiencing episodic of atrial fibrillation to sinus beat like 2 to 1 or 3 to 1) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Heart rate: heartbeat jumped up to 140-150 beats (Inconclusive) heartbeat jumped up to 140-150 beats.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ATRIAL FIBRILLATION (experiencing episodic of atrial fibrillation to sinus beat like 2 to 1 or 3 to 1) to be possibly related.    This case concerns a 66 year-old male patient with medical history of irregular heartbeat and cardiac ablation in 2017, who experienced the Serious Unexpected event of Atrial fibrillation and other non serious events. The event started 2 hours after the second dose of an unknown schedule of administration of Moderna COVID-19 Vaccine. Rechallenge for this event is Not applicable as no additional dosing will be given. Medical history of irregular heartbeat and cardiac ablation remains a confounder for this case. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Additional information has been requested.; Sender's Comments: This case concerns a 66 year-old male patient with medical history of irregular heartbeat and cardiac ablation in 2017, who experienced the Serious Unexpected event of Atrial fibrillation and other non serious events. The event started 2 hours after the second dose of an unknown schedule of administration of Moderna COVID-19 Vaccine. Rechallenge for this event is Not applicable as no additional dosing will be given. Medical history of irregular heartbeat and cardiac ablation remains a confounder for this case. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. 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, expiry unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected immunological vaccine failure. On an unspecified date, patient did an antibody test and the results came out to be negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  20211006267-Covid-19 vaccine ad26.cov2.s- suspected immunological vaccine 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: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: ASYMPTOMATIC COVID-19; This spontaneous report received from a consumer via a company representative 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: Unknown) dose was not reported, administered on MAR-2021 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 01-OCT-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 04-OCT-2021, the patient experienced asymptomatic covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) positive (twice). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000195927.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 40 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: 29-SEP-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: RECEIVED MODERNA COVID-19 VACCINE AS A SECOND DOSE; This spontaneous report received from a health care professional concerned a 32 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: 1805031, expiry: 31-DEC-2069) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included mrna 2416 for prophylactic vaccination.  On 03-SEP-2021, the patient experienced received moderna covid-19 vaccine as a second dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received moderna covid-19 vaccine as a second dose was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006533.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Gait inability, Hypoaesthesia, Pain in extremity, Palpitations
Clinical narrative: SWELLING IN BOTH FEET; CAN NOT WALK; HEART RACING; BURNING IN BOTH HANDS THAT STRETCHES FROM FINGER TIPS TO THE  ELBOW; HURTING IN BOTH HANDS THAT STRETCHES FROM FINGER TIPS TO THE  ELBOW; NUMBNESS IN BOTH HANDS TO THE ELBOW; BOTH FEET BURNING AND TINGLING; This spontaneous report received from a patient concerned a 76 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, non alcohol user, irregular heart beat (arrhythmia), and atrial fibrillation, and other pre-existing medical conditions included: Patient had no known allergies and did not had any 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: 041A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation.  On 16-APR-2021, the patient experienced swelling in both feet. On 16-APR-2021, the patient experienced can not walk. On 16-APR-2021, the patient experienced heart racing. On 16-APR-2021, the patient experienced burning in both hands that stretches from finger tips to the elbow. On 16-APR-2021, the patient experienced hurting in both hands that stretches from finger tips to the elbow. On 16-APR-2021, the patient experienced numbness in both hands to the elbow. On 16-APR-2021, the patient experienced both feet burning and tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from both feet burning and tingling, swelling in both feet, can not walk, heart racing, burning in both hands that stretches from finger tips to the elbow, numbness in both hands to the elbow, and hurting in both hands that stretches from finger tips to the elbow. This report was non-serious.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: SWELLING IN BOTH FEET; CAN NOT WALK; HEART RACING; BURNING IN BOTH HANDS THAT STRETCHES FROM FINGER TIPS TO THE  ELBOW; HURTING IN BOTH HANDS THAT STRETCHES FROM FINGER TIPS TO THE  ELBOW; NUMBNESS IN BOTH HANDS TO THE ELBOW; BOTH FEET BURNING AND TINGLING; This spontaneous report received from a patient concerned a 76 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, non alcohol user, irregular heart beat (arrhythmia), and atrial fibrillation, and other pre-existing medical conditions included: Patient had no known allergies and did not had any 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: 041A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation.  On 16-APR-2021, the patient experienced swelling in both feet. On 16-APR-2021, the patient experienced can not walk. On 16-APR-2021, the patient experienced heart racing. On 16-APR-2021, the patient experienced burning in both hands that stretches from finger tips to the elbow. On 16-APR-2021, the patient experienced hurting in both hands that stretches from finger tips to the elbow. On 16-APR-2021, the patient experienced numbness in both hands to the elbow. On 16-APR-2021, the patient experienced both feet burning and tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from both feet burning and tingling, swelling in both feet, can not walk, heart racing, burning in both hands that stretches from finger tips to the elbow, numbness in both hands to the elbow, and hurting in both hands that stretches from finger tips to the elbow. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Dizziness, Dyspnoea exertional
Clinical narrative: TINGLING IN BOTH LEGS FROM THE KNEES DOWN; COUGHED UP BLOOD (TASTED BLOOD AND SPIT UP BLOOD); DIZZINESS; BLURRED VISION; SWEATS; INTERMITTENT CHEST PAIN; SHORTNESS OF BREATH UPON EXERTION; HEADACHE; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 10-SEP-2021, the patient experienced dizziness. On 10-SEP-2021, the patient experienced blurred vision. On 10-SEP-2021, the patient experienced sweats. On 10-SEP-2021, the patient experienced intermittent chest pain.  On 10-SEP-2021, the patient experienced shortness of breath upon exertion. On 10-SEP-2021, the patient experienced headache.  On 28-SEP-2021, the patient experienced coughed up blood (tasted blood and spit up blood). Laboratory data included: Blood test (NR: not provided) could not find anything wrong, and Chest X-ray (NR: not provided) could not find anything wrong. On 03-OCT-2021, the patient experienced tingling in both legs from the knees down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling in both legs from the knees down, and the outcome of headache, dizziness, blurred vision, sweats, coughed up blood (tasted blood and spit up blood), intermittent chest pain and shortness of breath upon exertion was not reported. 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: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis, Headache, Hyperhidrosis, Paraesthesia, Vision blurred
Clinical narrative: TINGLING IN BOTH LEGS FROM THE KNEES DOWN; COUGHED UP BLOOD (TASTED BLOOD AND SPIT UP BLOOD); DIZZINESS; BLURRED VISION; SWEATS; INTERMITTENT CHEST PAIN; SHORTNESS OF BREATH UPON EXERTION; HEADACHE; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 10-SEP-2021, the patient experienced dizziness. On 10-SEP-2021, the patient experienced blurred vision. On 10-SEP-2021, the patient experienced sweats. On 10-SEP-2021, the patient experienced intermittent chest pain.  On 10-SEP-2021, the patient experienced shortness of breath upon exertion. On 10-SEP-2021, the patient experienced headache.  On 28-SEP-2021, the patient experienced coughed up blood (tasted blood and spit up blood). Laboratory data included: Blood test (NR: not provided) could not find anything wrong, and Chest X-ray (NR: not provided) could not find anything wrong. On 03-OCT-2021, the patient experienced tingling in both legs from the knees down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling in both legs from the knees down, and the outcome of headache, dizziness, blurred vision, sweats, coughed up blood (tasted blood and spit up blood), intermittent chest pain and shortness of breath upon exertion was not reported. 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: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a White and Hispanic or Latino 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: 1805029, expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 12-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 29-SEP-2021, patient experienced the headaches, stuffy nose and sneezing. On 29-Sep-2021, patient experienced the Covid-19 symptoms (suspected Covid-19 infection and suspected clinical vaccination failure). On 01-OCT-2021, patient lost sense of taste and smell and decided to get tested for Covid-19. On 01-Oct-2021, patient tested for Covid-19 infection. On 02-OCT-2021 (Reported as Saturday) the test resulted positive for Covid-19. It was reported that, physician was notified and there was no change in lifestyle of patient". On 04-OCT-2021, patient experienced the chest congestion, fatigue and body aches.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000195816.; Sender's Comments: V0: 20211006541-COVID-19 VACCINE AD26.COV2.S-Suspected 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION (BREAKTHROUGH); 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: hypertension, non smoker, and alcohol user. The patient had no known allergies. The patient was not pregnant at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: unknown) dose was not reported,1 total, administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-OCT-2021, the patient experienced breakthrough (suspected covid-19 infection) and the patient tested positive for Covid-19 with mild symptoms (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection (breakthrough) and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20211006677-covid-19 vaccine ad26.cov2.s-suspected 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
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Joint swelling, Muscle spasms, Pain, Ultrasound scan
Clinical narrative: FEELING  LITTLE TWINGES IN ANKLE; MUSCLE SPASM IN ANKLE; SWELLING IN ANKLE; DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 07-APR-2021 in the morning around 09:00-10:00 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-MAY-2021, the patient got a deep vein thrombosis. On 20-MAY-2021, the patient went to physician who scheduled an ultrasound on 26-MAY-2021, to verify the deep vein thrombosis and patient got those results that same day confirming the deep vein thrombosis. On 27-MAY-2021, the patient started treatment medication Xarelto and was on 15mg twice a day for 3 weeks, then 1-20mg pill daily through last Sunday, 26-SEP-2021. On 03-OCT-2021, patient felt like it was coming back. On the same day, patient was feeling little twinges/muscle spasms and had sharp ones at afternoon in ankle the area where patient had the deep vein thrombosis. Patient had swelling in ankle which also started on 03-OCT-2021 in the same place had it before and still has on. The twinges come and go. The patient would call physician on 04-OCT-2021. Patient stated that, the vaccination facility did not put a lot number on vaccination card. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in ankle, and the outcome of deep vein thrombosis, feeling little twinges in ankle and muscle spasm in ankle was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211007109-Covid-19 vaccine ad26.cov2.s- Deep vein thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement
Clinical narrative: BLOOD PRESSURE WENT CRAZY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced blood pressure went crazy. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood pressure went crazy was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling of eyelid, Urticaria
Clinical narrative: EYELIDS SWELLED; RASH ALL OVER THE BODY; HIVES AROUND THE BELLY BUTTON, ARMS, FACE AND BODY; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, and arthritis, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, administered on 06-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 APR-2021, the patient experienced hives around the belly button, arms, face and body. On JUN-2021, the patient experienced rash all over the body. On SEP-2021, the patient experienced eyelids swelled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives around the belly button, arms, face and body, rash all over the body and eyelids swelled was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: SEVERE CHILLS; FEVER OF 101; 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 was not reported, administered on 01-OCT-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 01-OCT-2021, the patient experienced severe chills. On 01-OCT-2021, the patient experienced fever of 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe chills and fever of 101 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE ADMINISTERED ONE WEEK TO 10 DAYS PAST EXPIRATION DATE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced vaccine administered one week to 10 days past expiration date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered one week to 10 days past expiration date was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a patient via a company representative concerned a male of unspecified age and other race. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was physically fit, regularly exercises, did not had any underlying health conditions and had zero risk factors for cardiovascular events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on SEP-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-OCT-2021, the patient was admitted to a local hospital due to tachycardia and after further evaluation, the medical team was able to confirm that the patient had suffered a heart attack. Number of days of hospitalization were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211008873 - Covid-19 vaccine ad26.cov2.s-heart attack. 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: Chills, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: FELT LIKE ABSOLUTE CRAP; CHILLS; FEVER; NAUSEA; This spontaneous report received from a parent via a company representative concerned a 27 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, start therapy date were not reported 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 patient experienced felt like absolute crud, chills, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like absolute crud, chills, fever, and nausea. This report was non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Medication error, Off label use
Clinical narrative: MEDICATION ERROR/PARTIAL DOSING; OFF LABEL USE AS A BOOSTER AFTER COMPLETING A SERIES OF PFIZER VACCINE; This spontaneous report received from a health care professional concerned a 74 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: 204B21A, expiry: 11-DEC-2021) 0.3 ml, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced medication error/partial dosing. On 30-SEP-2021, the patient experienced off label use as a booster after completing a series of pfizer vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error/partial dosing and off label use as a booster after completing a series of pfizer vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER POST VACCINATION; 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 fever post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever post vaccination was not reported. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: EXTRA DOSE ADMINISTERED; This spontaneous report received from a health care professional concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, expiry: 21-OCT-2021) dose was not reported, administered on 05-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-OCT-2021, the patient experienced extra dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extra dose administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-OCT-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 04-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Flank pain
Clinical narrative: BACK PAIN; SIDE PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced back pain, and side pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain, and side pain. This report was non-serious. This case, from the same reporter is linked to 20211009261.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: This spontaneous report received from a patient via the regulatory authority, concerned a patient of unspecified age and sex. The patient's height and weight not reported. No past medical history, concomitant medications or concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# 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. On an unspecified date, patient experienced body aches and nausea. The action taken with COVID-19 vaccine ad26.cov2.s: Not applicable. The patient recovered from body aches and nausea. This report: non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: POSSIBLY EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced possibly expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possibly expired vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Hunger, Increased appetite
Clinical narrative: HUGE APPETITE; HUNGRY 80 PERCENT OF THE TIME/WAKE UP AT NIGHT STARVING; BACK ACHE; WAKE UP AT NIGHT; GENERALLY UNWELL; HEADACHE; TIRED; MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 huge appetite, hungry 80 percent of the time/wake up at night starving, back ache, wake up at night, generally unwell, headache, tired, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain, back ache, headache, tired, generally unwell, huge appetite, hungry 80 percent of the time/wake up at night starving and wake up at night was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Middle insomnia, Myalgia
Clinical narrative: HUGE APPETITE; HUNGRY 80 PERCENT OF THE TIME/WAKE UP AT NIGHT STARVING; BACK ACHE; WAKE UP AT NIGHT; GENERALLY UNWELL; HEADACHE; TIRED; MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 huge appetite, hungry 80 percent of the time/wake up at night starving, back ache, wake up at night, generally unwell, headache, tired, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pain, back ache, headache, tired, generally unwell, huge appetite, hungry 80 percent of the time/wake up at night starving and wake up at night was not reported. This report was non-serious.