chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstituted with unapproved diluent.; Menveo reconstituted with unapproved diluent.; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 21-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Menveo lyophilized powder reconstituted with unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. This case is linked with case US2021178414, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021178414:Same reporter.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given subcutaneously instead of IM; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix (subcutaneous) and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route 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. Pharmacist reported that an patient received Boostrix vaccine subcutaneously instead of Intramuscularly, which led to intramuscular formulation administered by other route. No patient information was reported. The reporter consented to follow up.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: pediatric dose of Engerix-B was administered to an adult; pediatric dose of Engerix-B was administered to an adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 43-year-old female patient who received HBV (Engerix B pediatric) (batch number 9KG7R, expiry date 9th May 2022) for prophylaxis.   On 24th August 2021, the patient received Engerix B pediatric. On 24th August 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The clinical team lead reported that, the pediatric dose of Engerix-B was administered to an adult patient, which led to underdose and adult use of a child product The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: second on 9Oct2020 / not received the third; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 47-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (1st dose received on 4th September 2020, batch number BG92Z,expiry date 4th July 2022) and Engerix b (2nd dose received on 9th October 2020, batch number BG92Z,expiry date 4th July 2022).  On an unknown date, the patient received the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by the nurse. The age vaccination was not applicable for this report. The patient missed 3rd dose of Engerix b at the appropriate time an till now, the patient did not receive 3rd dose, which led to incomplete course of vaccination. The reporter consented to followup.
Age: 57.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 57-year-old male patient who received HAV (Havrix) (batch number D94MK, expiry date 5th July 2021) for prophylaxis.   On 24th August 2021, the patient received Havrix. On 24th August 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional case details were reported as follows: Medical Assistant reported that, the patient received an expired dose of Havrix, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose more than one month ago not administered with 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HBV (Engerix B).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable. The patient received first dose more than one month ago (batch number: N4GA4, expiry date: 28th February 2023). The patient did not receive 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021179660:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given the adjuvant portion only; given the adjuvant portion only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number D4PA4, expiry date 10th February 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 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 age at vaccination was not reported. The Clinical Coordinator reported that, the patient received the adjuvant portion of Shingrix only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021180797, US2021180799, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021180797:same reporter US-GLAXOSMITHKLINE-US2021180799:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given the adjuvant portion only.; given the adjuvant portion only.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number D4PA4, expiry date 10th February 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 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 age at vaccination was not reported. The clinical coordinator reported that, the patient received the adjuvant portion of Shingrix only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021180796, US2021180799, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021180796:same reporter US-GLAXOSMITHKLINE-US2021180799:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given the adjuvant portion only.; given the adjuvant portion only.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number D4PA4, expiry date 10th February 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 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 age at vaccination was not reported. The clinical coordinator reported that, the patient received the adjuvant portion of Shingrix only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021180796, US2021180797, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021180797:same reporter US-GLAXOSMITHKLINE-US2021180796:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: received the diluent portion only; received the diluent portion only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number DE9LR, expiry date 27th January 2023) for prophylaxis.   On 26th August 2021, the patient received the 1st dose of Shingrix. On 26th August 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 age at vaccination was not reported. The nurse reported that, the patient received the diluent portion only of Shingrix without being reconstituted with the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Sex: F
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 was received from a 72-year-old female patient of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was 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 is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, after taking the vaccination, the patient became ill (feeling sick), and was diagnosed with coronavirus disease (COVID-19) (suspected covid-19 infection, and suspected clinical vaccination failure). On an unspecified date, after being diagnosed with COVID-19, she was prescribed with Xarelto (rivaroxaban). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint.; Sender's Comments: V0: 20210847448- 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
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to mushrooms, non-alcohol user, and cigarette smoker, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose was not reported, administered 1 total on 19-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-AUG-2021, patient experienced symptoms of fever and fatigue (suspected clinical vaccination failure and covid-19 infection). On 23-AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive.(covid-19 infection). The action taken with covid-19 vaccine was not applicable. The outcome of the covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846633.; Sender's Comments: V0:20210849794 - covid-19 vaccine -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
Sex: U
Vaccine: COVID19
Symptoms: Eye injury
Clinical narrative: POSSIBLE PERMANENT EYE DAMAGE; This spontaneous report received from a consumer via social media (twitter) concerned a patient of unspecified age and sex, unspecified race and ethnicity. Initial information was processed along with the additional information received from consumer on 26-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, the patients were hospitalized' (date unspecified). It also reported that the patient might have permanent eye damage' The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible permanent eye damage was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210861653.; Sender's Comments: V0: 20210850188- Covid-19 vaccine ad26.cov2.s- Possible permanent eye damage. 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: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age, race & ethinicity. 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) (1 Total) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, and the patient was fully vaccinated along with his wife and both got covid (suspected covid-19 infection), and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was associated with Product Quality Complaint-90000190997. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20210859063.; Sender's Comments: V0: 20210852596-Covid-19 vaccine ad26.cov2.-Suspected Clinical Vaccine Failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. 20210852596-Covid-19 vaccine ad26.cov2.s-Suspected Covid 19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; 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 and has been requested. Concomitant medications included guselkumab.  On an unspecified date, the patient experienced covid-19 test positive. Laboratory data (dates unspecified) 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 covid-19 test positive was not reported. This report was non-serious. This case, involving the same patient is linked to 20210844246. This case was associated with product quality complaint: 90000191182; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: BROKE OUT IN FULL BODY BLISTERS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 broke out in full body blisters. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of broke out in full body blisters was not reported. This report was non-serious. This case, from the same reporter is linked to 20210858509.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Oxygen saturation, 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 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: 1805020 and expiry: Unknown) dose was not reported, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, Laboratory data included: Body temperature (NR: not provided) 97.6 range, and Oxygen saturation (NR: not provided) 97/98. On 11-AUG-2021, the patient began to show symptoms of Covid19 which includes scratchy throat, runny nose, cough, loss of taste/smell (suspected covid-19 infection) and tested positive on 16-AUG-2021 (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191110. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. Based on the evaluation/investigation performed.  Additional information received on 27-AUG-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: Version created to update additional information received. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result. This update does not alter the prior causality assessment of previously reported events.  20210855251-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
Sex: U
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: BREAKTHROUGH INFECTION; This spontaneous report was received from. This report concerned multiple patients of unknown ethnicity and race. The objective of this study was to describe Predominance of antibody-resistant SARS-CoV-2 variants in vaccine breakthrough cases. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: UNKNOWN) 1 total, 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 breakthrough infection. As per the reporter, " the vaccine breakthrough infections are more likely to be caused by immunity-evading variants as compared to unvaccinated infections. The predominance of immune-evading variants among breakthrough cases indicated selective pressure for immune-resistant variants locally over time in the vaccinated population concurrent with ongoing viral circulation in the community". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breakthrough infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210855307. This case was associated with product quality complaint number: 90000191350.; Sender's Comments: V0: 20210855269 -covid-19 vaccine ad26.cov2.s- Breakthrough infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report was received from literature. This report concerned multiple (2) patients of unknown race and ethnicity. The objective of this study was to describe predominance of antibody-resistant SARS-CoV-2 variants in vaccine breakthrough cases. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number unknown) 1 total, 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 patients experienced confirmed covid-19 infection, and confirmed clinical vaccination failure. Laboratory data (dates unspecified) 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 and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number: 90000191350. This case, from the same reporter is linked to 20210855269.; Sender's Comments: V0- 20210855307- 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
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Blood test, Muscle spasms
Clinical narrative: SMALL NEEDLE IN THE HEART AND IT WAS PAINFUL, HEART PAIN WAS STILL HAPPENING THOUGH IT GOES ON AND OFF; CRAMP IN HER LEFT CALF (OUTER SIDE OF THE LEG); This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cat allergy, and lot of unspecified allergies, and other pre-existing medical conditions included: The patient was athletic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 14-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On JAN-2021, (7 month ago) Laboratory data included: Blood test (NR: not provided) Everything was perfect.  On 14-AUG-2021, within 15 minutes after received vaccine, the patient experienced small needle in the heart and it was painful, heart pain was still happening though it goes on and off. The patient never experienced anything like that before. It lasted 1 minute and went away. On the same day, 20 minutes after getting the vaccine, the patient experienced cramp in her left calf (outer side of the leg). Then it went away in a few minutes. Then she got these two symptoms 4 or 5 hours later that night. It was reported that the heart pain was still happening though it goes on and off. The patient did not contact any Doctors. She was waiting to contact a cardiologist The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cramp in her left calf (outer side of the leg), and had not recovered from small needle in the heart and it was painful, heart pain was still happening though it goes on and off. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210857265.; Sender's Comments: V0: 20210857104-COVID-19 VACCINE AD26.COV2.S- small needle in the heart and it was painful, heart pain was still happening though it goes on and off. 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: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer (neighbour) concerned a male patient of unspecified age, 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 (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total, administered in 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 had laboratory test on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid antibody test which showed negative result (suspected immunological vaccine failure). 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). This case, from the same reporter is linked to 20210843278 and 20210853492. This case is associated with product quality complaint: 90000191321.; Sender's Comments: V0:20210857119-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: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; 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 past medical history included: covid-19. 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 fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be this record indicates a medical adverse event for the patient. there is no product quality issue reported. Approval to void this record due to no pqc identified. Void:Y based on the PQC evaluation/investigation performed.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: RECEIVED A VACCINE FROM A BAD / INEFFECTIVE BATCH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on unspecified day in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On unspecified day, in APR-2021 (3 weeks ago), the patient received a vaccine from a bad / ineffective batch and was advised to get another vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received a vaccine from a bad / ineffective batch was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191305.; Sender's Comments: V0: 20210857289- Covid-19 vaccine ad26.cov2.s- Received a vaccine from a bad / ineffective batch. 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: Asymptomatic COVID-19
Clinical narrative: ASYMPTOMATIC COVID-19; This spontaneous report received from a patient via a company representative concerned a 60 year old female. The patient's weight was not reported and height was 149.86 centimeters. The patient's concurrent conditions included: down syndrome, and seasonal allergy. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced asymptomatic covid-19. 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 asymptomatic covid-19 was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRM IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 72 year old male. The patient's weight was 180 pounds, and height was 175.26 centimeters. The patient's past medical history included prostate cancer and had chickenpox for which the patient's mom gave him lemon tea and he broke out worse. It was reported that the suspected was lemon. The patient had food and drug allergies mainly of penicillin allergy and lemon (lemonade, lemon tea) allergy for which stopped drinking lemonade. The patient had one shot of vaccine, had no past history of similar event, had not taken any vaccine since childhood, no adverse event after any previous vaccinations. He had no history of hospitalization in last 30 days with cause, had no family history of any disease (relevant to vaccination) or allergy. The patient had no other suspected causes including co-administered vaccines or risk factors. The patient did not know of pre-existing acute illness 30 days prior to vaccination and also stated that even not known for prostate thing (had history of prostate cancer) was still a problem and haven't had prostate-specific antigen (PSA). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: unknown) dose was not reported, 1 total administered on 26-JUN-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in early AUG-2021, the patient tested negative for COVID-19 antibody test (confirm immunological vaccine failure).  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirm immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with RA complaint number: 90000191365  Additional information was received from patient on 30-AUG-2021. The following information was updated and incorporated into the case: The patient's height, weight, pre medical history (prostate cancer, chickenpox, penicillin allergy and lemon (lemonade, lemon tea) allergy), number was added.; Sender's Comments: V2-The following information was updated and incorporated into the case: The patient's height, weight, pre medical history (prostate cancer, chickenpox, penicillin allergy and lemon (lemonade, lemon tea) allergy) number was added. 20210857423;COVID-19 VACCINE AD26.COV2.S-Confirm immunological vaccine failure This event(s) is  considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and  has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC BENEFIT (WART ON LEFT THUMB THAT IS CLEARING UP AND NEW SKIN GROWING IN THAT AREA); This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: wart on the left hand. 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, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced unexpected therapeutic benefit (wart on left thumb that is clearing up and new skin growing in that area). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit (wart on left thumb that is clearing up and new skin growing in that area) was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Dysgeusia
Clinical narrative: POWERFUL METAL TASTE IN MOUTH; HAVEN'T BEEN THE SAME; This spontaneous report received from a patient via a company representative concerned a 59 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: 07-SEP-2021) dose was not reported, administered on 21-MAR-2021 09:15 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the patient experienced haven't been the same. On 26-MAR-2021, the patient experienced powerful metal taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from powerful metal taste in mouth, and the outcome of haven't been the same was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Gait disturbance, Joint stiffness, Neurological symptom, Paraesthesia
Clinical narrative: HARD TO WALK; STIFF KNEES; SUSPECTED GUILLAIN BARRE SYNDROME; TINGLING IN KNEES; INFLAMMATION IN KNEES; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included: knee replacement surgeries, and concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: Patient have no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 21-OCT-2021) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced inflammation in knees. On an unspecified date, the patient experienced hard to walk, stiff knees, suspected guillain barre syndrome, and tingling in knees. Treatment medications (dates unspecified) included: tramadol hydrochloride, and diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inflammation in knees, hard to walk, tingling in knees, stiff knees, and suspected guillain barre syndrome. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, X-ray
Clinical narrative: HARD TO WALK; STIFF KNEES; SUSPECTED GUILLAIN BARRE SYNDROME; TINGLING IN KNEES; INFLAMMATION IN KNEES; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included: knee replacement surgeries, and concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: Patient have no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 21-OCT-2021) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced inflammation in knees. On an unspecified date, the patient experienced hard to walk, stiff knees, suspected guillain barre syndrome, and tingling in knees. Treatment medications (dates unspecified) included: tramadol hydrochloride, and diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inflammation in knees, hard to walk, tingling in knees, stiff knees, and suspected guillain barre syndrome. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELL'S PALSY; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported, administered 1 total, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that the consumer mentioned in passing about a friend of a friend who received the Janssen COVID-19 vaccine and then developed Bell's palsy on an unspecified date. The action taken with covid-19 vaccine was not applicable. The outcome of Bell's palsy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210854887.; Sender's Comments: V0: 20210858509- Covid-19 vaccine -Bell's palsy. This event is considered unassessable. The event 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.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colitis ulcerative, Colonoscopy, Constipation, Diarrhoea, Gait inability
Clinical narrative: SERIOUS MEDICAL PROCEDURE FOR ULCERATIVE COLITIS; COULDN'T WALK FROM CAR TO JOB; ENDED IN EMERGENCY ROOM FOR CONSTIPATION; REACTIONS IN THROAT FOR WHICH EGD PROCEDURE IS SCHEDULED; I WAS ILL, LIKE I HAD COVID AGAIN, WAS ON COUCH ALL DAY, AND DOWN ALL WEEKEND; BATHROOM ISSUES WENT FROM LOOSE TO COULDN'T GO TO BATHROOM; LEGS, FEET, HAND, WRIST, FINGERS, LOWER BACK DOWN WAS NUMB; This spontaneous report received from a patient concerned a 64 year old  female of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and other pre-existing medical conditions included: The patient had no bowel issues, no numbness issues, no physical ailments before shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 at 10 or 10:30 hours to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 after vaccination by 17:00 hours patient experienced like she had covid 19 again, patient was on couch all the day and down all weekend and the patient had bathroom issues, couldn't walk from car to job, legs, feet, hand, wrist, fingers, lower back down was numb. This since 10-APR-2021 continued and symptoms worsened. The patient's bathroom issues went from loose to couldn't go to bathroom, she went to the physician's office and ended in Emergency Room for constipation, was referred to gastroenterologist. The patient has been under doctors care and had serious medical procedure for ulcerative colitis. Reactions in throat due to shot for which the patient has been scheduled for esophagogastroduodenoscopy procedure. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) Unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bathroom issues went from loose to couldn't go to bathroom, couldn't walk from car to job, and legs, feet, hand, wrist, fingers, lower back down was numb, and the outcome of ended in emergency room for constipation, serious medical procedure for ulcerative colitis, reactions in throat for which esophagogastroduodenoscopy procedure is scheduled and i was ill, like i had covid again, was on couch all day, and down all weekend was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210858787--Ulcerative colitis. 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).