chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose about a year ago, have not received second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received about a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patients (about 10 to 15) did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not have specific patient identifiers. The reporter did not consent to follow up. The details were reported for 1st dose of Shingrix.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: exposure to freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 48-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 24BM2, expiry date 30th June 2022) 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 16th September 2021, 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 case details were reported as follows: The reporter called due to their discovery that patient was inadvertently administered on 16th September 2021 the vaccines that were in the temperature excursion, which led to incorrect storage of drug. The MI agent informed pharmacist the vaccines should be discarded due to exposure to freezing temperatures 31.5 Fahrenheit for 13 hours. The reporter did not consent to follow up. This is 1 of 7 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021198147:same reporter US-GLAXOSMITHKLINE-US2021198142:same reporter US-GLAXOSMITHKLINE-US2021198144:same reporter US-GLAXOSMITHKLINE-US2021198148:same reporter US-GLAXOSMITHKLINE-US2021198149:same reporter US-GLAXOSMITHKLINE-US2021198148:same reporter
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: exposure to freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 60-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 24BM2, expiry date 30th June 2022) 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 16th September 2021, 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 case details were reported as follows: The reporter called due to their discovery that patient was inadvertently administered on 16th September 2021 the vaccines that were in the temperature excursion, which led to incorrect storage of drug. The MI agent informed pharmacist the vaccines should be discarded due to exposure to freezing temperatures 31.5 Fahrenheit for 13 hours. The reporter did not consent to follow up. This is 1 of 7 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021198148:same reporter US-GLAXOSMITHKLINE-US2021198147:same reporter US-GLAXOSMITHKLINE-US2021198139:same reporter US-GLAXOSMITHKLINE-US2021198149:same reporter US-GLAXOSMITHKLINE-US2021198144:same reporter
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: exposure to freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 31-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 24BM2, expiry date 30th June 2022) 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 16th September 2021, 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 case details were reported as follows: The reporter called due to their discovery that patient was inadvertently administered on 16th September 2021 the vaccines that were in the temperature excursion, which led to incorrect storage of drug. The agent informed pharmacist the vaccines should be discarded due to exposure to freezing temperatures 31.5 Fahrenheit for 13 hours. The reporter did not consent to follow up. This is 1 of 7 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021198139:same reporter US-GLAXOSMITHKLINE-US2021198147:same reporter US-GLAXOSMITHKLINE-US2021198142:same reporter US-GLAXOSMITHKLINE-US2021198149:same reporter US-GLAXOSMITHKLINE-US2021198148:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: didn't receive second shot; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 10 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: U
Vaccine: RV1
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an expired vaccine; This case was reported by a other health professional and described the occurrence of expired vaccine used in a patient who received Rota (Rotarix lyophilized formulation) (batch number unknown, expiry date 7th September 2021) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 20th September 2021, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 20th September 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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 details were reported as follows: The age at vaccination was not reported. On 20th September 2021, patient received Rotarix, which was expired on 7th September 2021. No reactions was reported. Unknown patient identifiers. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3 doses of Shingrix; This case was reported by a pharmacist 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 in September 2020) and Shingrix (received 2nd dose in November 2020).   In March 2021, the patient received the 3rd dose of Shingrix. In March 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: Age at vaccination was not reported but the patient was over 60 years at the time of reporting. The pharmacist was looking for guidance because the patient received 3rd dose of Shingrix vaccine which led to extra dose administered. No information was provided about lot number or expiration date. Patient was not immunocompromised. Pharmacist mentioned that this situation was already reported. The reported did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: liquid antigen vial of without reconstitution with the lyophilized powder; was given the liquid antigen vial of without reconstitution; This case was reported by a pharmacist and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th September 2021, the patient received Shingrix. On 20th 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 reported as follows: The age at vaccination was not reported. A patient was given the liquid antigen vial of Shingrix without reconstitution with the lyophilized powder vial which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Pyrexia
Clinical narrative: fever; nerve pain, head, ear, throat; This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of no adverse event the patient never had any symptoms with flu shot and the patient gets it every year.   In September 2021, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season. In September 2021, 10 hours after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced fever and nerve pain. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the nerve pain was not recovered/not resolved.   The reporter considered the fever and nerve pain to be possibly related to Shingrix. It was unknown if the reporter considered the fever and nerve pain to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as the patient self-reported the case. The patient received Shingrix vaccine in right arm and the flu shot in left arm (did not know which one) 2 and a half weeks ago from reporting date (did not remember exact date). The patient believed he had a reaction to Shingrix. About 10 hours after getting vaccines he reported a fever and nerve pain on the top, left side of head (scalp) that radiates down to his left ear and left side of throat. The fever went away after a day, but the nerve pain remains after 2 and a half weeks. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the liquid adjuvant; administered only the liquid adjuvant; This case was reported by a pharmacist via a representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received 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 the age at vaccination was not reported. The pharmacist reported that a nurse in a neighboring facility administered only the liquid adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Gait disturbance, Mobility decreased, Pyrexia
Clinical narrative: Started to feel very weak; Can barely move the body; Almost can not walk; 100.2°  fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Started to feel very weak), MOBILITY DECREASED (Can barely move the body), GAIT DISTURBANCE (Almost can not walk) and PYREXIA (100.2°  fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21O, 021M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced ASTHENIA (Started to feel very weak), MOBILITY DECREASED (Can barely move the body), GAIT DISTURBANCE (Almost can not walk) and PYREXIA (100.2°  fever). At the time of the report, ASTHENIA (Started to feel very weak), MOBILITY DECREASED (Can barely move the body), GAIT DISTURBANCE (Almost can not walk) and PYREXIA (100.2°  fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Body temperature: 100.2 (High) High.         No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received contain  no new information. On 12-Sep-2021: Follow up received contain updated event out case as recovered/resolved.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Fatigue, Feeling abnormal, Muscular weakness
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; BRAIN FOG; FATIGUE; STABBY BONE PAIN IN HER ARMS AND LEGS; MUSCLE WEAKNESS IN THE ARMS AND LEGS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height and weight were not reported. The patient experienced drug allergy when treated with ciprofloxacin/fluoroquinolones and levaquin (levofloxacin). She had stabby bone pain in her arms and legs when she took ciprofloxacin/fluoroquinolones. She had lost a tendon 10 years ago in the back of her calf muscle (she believed it was her left leg). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978 and expiry: unknown) dose was not reported, frequency time 1 total administered on 23-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the patient experienced muscle weakness in the arms and legs. On 07-APR-2021, she experienced a lot of stabby bone pain in her arms and legs. On 10-APR-2021, she experienced fatigue. On 29-AUG-2021, she experienced brain fog and began having symptoms such as a pain in her right sinus and felt sweaty. She thought that, she had a sinus infection. Eventually, on 01-SEP-2021 (Wednesday), she had fever of 101 F (fahrenheit) (ranging from 100-100.5 on average). On 02-Sep-2021 (Thursday), she also had a severe headache. She went through Rapid Covid-19 test and the results were positive for Covid-19. The above symptoms were diagnosed as part of being the break through covid-19 infection (suspected covid-19 infection and suspected clinical vaccination failure). She treated her own symptoms with sinus medication and Tylenol (paracetamol). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stabby bone pain in her arms and legs, and fatigue on 15-MAY-2021, and muscle weakness in the arms and legs on 10-APR-2021, was recovering from suspected covid-19 infection, had not recovered from brain fog, 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: 90000193677.; Sender's Comments: V0:20210932343 - 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; BRAIN FOG; FATIGUE; STABBY BONE PAIN IN HER ARMS AND LEGS; MUSCLE WEAKNESS IN THE ARMS AND LEGS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height and weight were not reported. The patient experienced drug allergy when treated with ciprofloxacin/fluoroquinolones and levaquin (levofloxacin). She had stabby bone pain in her arms and legs when she took ciprofloxacin/fluoroquinolones. She had lost a tendon 10 years ago in the back of her calf muscle (she believed it was her left leg). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978 and expiry: unknown) dose was not reported, frequency time 1 total administered on 23-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the patient experienced muscle weakness in the arms and legs. On 07-APR-2021, she experienced a lot of stabby bone pain in her arms and legs. On 10-APR-2021, she experienced fatigue. On 29-AUG-2021, she experienced brain fog and began having symptoms such as a pain in her right sinus and felt sweaty. She thought that, she had a sinus infection. Eventually, on 01-SEP-2021 (Wednesday), she had fever of 101 F (fahrenheit) (ranging from 100-100.5 on average). On 02-Sep-2021 (Thursday), she also had a severe headache. She went through Rapid Covid-19 test and the results were positive for Covid-19. The above symptoms were diagnosed as part of being the break through covid-19 infection (suspected covid-19 infection and suspected clinical vaccination failure). She treated her own symptoms with sinus medication and Tylenol (paracetamol). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stabby bone pain in her arms and legs, and fatigue on 15-MAY-2021, and muscle weakness in the arms and legs on 10-APR-2021, was recovering from suspected covid-19 infection, had not recovered from brain fog, 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: 90000193677.; Sender's Comments: V0:20210932343 - 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: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned 4 patients of unspecified age, sex, race and ethnicity. 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, 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, 4 patients experienced suspected immunological vaccine failure. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test (NR: not provided) negative. As per reporter "4 out of 5 patients who received the Janssen COVID-19 vaccine tested negative for antibodies in a small study group. Reporter complained about the vaccine stating that they do not believe in its efficacy. Since the reporter had a perceived lack of effect (LOE) based on their expectation from the product and the timing is unclear (no information on when the antibody test was done after the vaccine administration)". 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 report was associated with product quality complaint: 90000193783.; Sender's Comments: V0: 20210934975-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
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Migraine, Pyrexia, Vision blurred
Clinical narrative: VOMITING; BLURRY VISION; DIZZINESS; NOT FEELING WELL; FEVER; HEADACHE/MIGRAINE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid 19, and headache, and concurrent conditions included: non alcoholic, non smoker, and azithromycin allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: 21-SEP-2021) dose was not reported, administered on 26-AUG-2021 14:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 26-AUG-2021, the patient experienced headache/migraine. On 27-AUG-2021, the patient experienced not feeling well. On 27-AUG-2021, the patient experienced fever. On 01-SEP-2021, the patient experienced blurry vision. On 01-SEP-2021, the patient experienced dizziness. On 09-SEP-2021, treatment medications included: sumatriptan. On 12-SEP-2021, the patient experienced vomiting. Additional treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine was not applicable. The patient recovered from blurry vision, dizziness, and vomiting on SEP-2021, not feeling well, and fever, and headache/migraine on 12-SEP-2021. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; BLURRY VISION; DIZZINESS; NOT FEELING WELL; FEVER; HEADACHE/MIGRAINE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid 19, and headache, and concurrent conditions included: non alcoholic, non smoker, and azithromycin allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: 21-SEP-2021) dose was not reported, administered on 26-AUG-2021 14:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 26-AUG-2021, the patient experienced headache/migraine. On 27-AUG-2021, the patient experienced not feeling well. On 27-AUG-2021, the patient experienced fever. On 01-SEP-2021, the patient experienced blurry vision. On 01-SEP-2021, the patient experienced dizziness. On 09-SEP-2021, treatment medications included: sumatriptan. On 12-SEP-2021, the patient experienced vomiting. Additional treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine was not applicable. The patient recovered from blurry vision, dizziness, and vomiting on SEP-2021, not feeling well, and fever, and headache/migraine on 12-SEP-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Glomerular filtration rate, Medication error, Proteinuria, SARS-CoV-2 antibody test
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; MEDICATION ERROR; This spontaneous report was received from literature. This report concerned a 67 year old male of unspecified ethnicity. The objective of this study was to describe the impact of rituximab on humoral response to COVID-19 booster vaccine and antibody kinetics in patients with ANCA vasculitis. The patient's height, and weight were not reported. The patient's concurrent conditions included: microscopic polyangiitis phenotype, and anca (anti-neutrophil cytoplasmic antibody) vasculitis. The patient was previously (4 month before vaccine first dose) treated with steroids for microscopic polyangiitis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and batch number were not reported , expiry: unknown) one total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included rituximab for microscopic polyangiitis, and bnt (pfizer vaccine)162 for prophylactic vaccination..  On an unspecified date, the patient experienced confirmed immunological vaccination failure, and medication error. Laboratory data (dates unspecified) included: ANCA (NR: not provided) proteinase 30.8 u/mL, Estimated GFR (NR: not provided) 68 mL/min (1.73 x m2, Proteinuria (NR: not provided) 91 mg, and SARS-CoV-2 IgG antibody test (NR: not provided) More than 12 AU. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccination failure and medication error was not reported. The author has provided data for the first demonstration of antibody development post booster dose of the COVID-19 vaccine in associated vasculitis (AAV) patients on rituximab maintenance therapy. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20210927182. This case associated with product quality complaint.; Sender's Comments: V0: 20210935336-COVID-19 VACCINE AD26.COV2.S-Confirmed 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, CONMEDS-OTHER SUSPECT DRUGS
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; MEDICATION ERROR; This spontaneous report was received from literature. This report concerned a 67 year old male of unspecified ethnicity. The objective of this study was to describe the impact of rituximab on humoral response to COVID-19 booster vaccine and antibody kinetics in patients with ANCA vasculitis. The patient's height, and weight were not reported. The patient's concurrent conditions included: microscopic polyangiitis phenotype, and anca (anti-neutrophil cytoplasmic antibody) vasculitis. The patient was previously (4 month before vaccine first dose) treated with steroids for microscopic polyangiitis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and batch number were not reported , expiry: unknown) one total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included rituximab for microscopic polyangiitis, and bnt (pfizer vaccine)162 for prophylactic vaccination..  On an unspecified date, the patient experienced confirmed immunological vaccination failure, and medication error. Laboratory data (dates unspecified) included: ANCA (NR: not provided) proteinase 30.8 u/mL, Estimated GFR (NR: not provided) 68 mL/min (1.73 x m2, Proteinuria (NR: not provided) 91 mg, and SARS-CoV-2 IgG antibody test (NR: not provided) More than 12 AU. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccination failure and medication error was not reported. The author has provided data for the first demonstration of antibody development post booster dose of the COVID-19 vaccine in associated vasculitis (AAV) patients on rituximab maintenance therapy. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20210927182. This case associated with product quality complaint.; Sender's Comments: V0: 20210935336-COVID-19 VACCINE AD26.COV2.S-Confirmed 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, CONMEDS-OTHER SUSPECT DRUGS
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATHS; This spontaneous report received from a consumer via a company representative concerned 3 patients of unspecified sex, 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 administration not reported, batch number: Unknown 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, on an unknown date, JNJ vaccine caused 3 known deaths". The patients died from unknown cause of death. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event death was fatal This report was serious (Death).; Sender's Comments: V0: 20210936591-covid-19 vaccine ad26.cov2.s-Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SEVERE REACTIONS; This spontaneous report received from a patient via a company representative concerned 29 patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  "It was reported that, on an unknown date, the patients experienced severe reactions". The action taken with covid-19 vaccine  was not applicable. The outcome of severe reactions was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned an 8 decade 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: 043A21A, expiry: 19-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Feeling abnormal, Headache
Clinical narrative: ACHY; COUGH; FEEL LIKE CRAP; CHILLS; TIRED; HEADACHE; 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, 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 achy, cough, feel like crap, chills, tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, achy, chills, cough, headache and feel like crap was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHY; COUGH; FEEL LIKE CRAP; CHILLS; TIRED; HEADACHE; 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, 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 achy, cough, feel like crap, chills, tired, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, achy, chills, cough, headache and feel like crap was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain, Contusion, Extra dose administered, Fatigue
Clinical narrative: EXHAUSTED; FELT PAIN ON THE FRONT UPPER CHEST OF THE LEFT SIDE BELOW THE SHOULDER AREA; UNUSUAL BRUISING IN DIFFERENT PLACES; DOUBLE DOSE SHOT OF THE VACCINE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: Patient did not have medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-AUG-2021, the patient experienced double dose shot of the vaccine. On 18-AUG-2021, the patient experienced bruising in different places. On 19-SEP-2021, the patient experienced felt pain on the front upper chest of the left side below the shoulder area. On an unspecified date, the patient experienced exhausted. Laboratory data included: Blood pressure (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruising in different places, and the outcome of double dose shot of the vaccine and felt pain on the front upper chest of the left side below the shoulder area was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a health care professional and concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (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 inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FELT DOWN DUE TO HIGH FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 felt down due to high fever. The action taken with covid-19 vaccine was not applicable. The outcome of felt down due to high fever was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF AN OPENED VILE OF THE JNJ COVID19 VACCINE WHICH WAS LEFT OPEN AT ROOMS TEMPERATURE FOR 6 HOURS; This spontaneous report received from a health care professional concerned a 54 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies and none medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 11-DEC-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-SEP-2021, the patient experienced administration of an opened vile of the JNJ covid19 vaccine which was left open at rooms temperature for 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an opened vile of the JNJ covid19 vaccine which was left open at rooms temperature for 6 hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID-19 AFTER VACCINATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced got covid-19 after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid-19 after vaccination was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: NO PERIOD SINCE COVID-19 VACCINATION; This spontaneous report received from a consumer and concerned an adult female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: autism. 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 no period since covid-19 vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no period since covid-19 vaccination. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Pain in extremity, Pyrexia
Clinical narrative: SLEPT FOR LIKE 16 HOURS THE FIRST DAY; SORE ARM; FATIGUED; SLIGHT FEVER; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced slept for like 16 hours the first day, sore arm, fatigued, and slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for like 16 hours the first day, sore arm, fatigued, and slight fever. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis
Clinical narrative: REALLY TIRED; FATIGUE LIKE WALKING FOR A MILE; SWEATY FOR 20 MINUTES AFTER THEN HE WAS FINE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 9320) dose was not reported, administered on 07-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced sweaty for 20 minutes after then he was fine. On 08-APR-2021, the patient experienced really tired. On 08-APR-2021, the patient experienced fatigue like walking for a mile. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweaty for 20 minutes after then he was fine on 07-APR-2021, and really tired, and fatigue like walking for a mile on 09-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: NAUSEA; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. The batch numbers were not reported and have been requested. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine was not applicable. The outcome of nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210941047.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Medication error
Clinical narrative: TOOK A THIRD PFIZER AND A SHOT OF JANSSEN COVID-19 VACCINE; CHEST PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced took a third pfizer and a shot of janssen covid-19 vaccine, and chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and the outcome of took a third pfizer and a shot of janssen covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; TEMPERATURE EXCURSION (EXPOSED TO 27F DEGREES FOR 44 MIN); This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-AUG-2021, the patient experienced temperature excursion (exposed to 27f degrees for 44 min). On an unspecified date, the patient experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of the temperature excursion (exposed to 27f degrees for 44 min) and out of specification product use was not reported. This report was non-serious.