chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Limb injury, Malaise
Clinical narrative: felt sick; Injury/right shoulder; Weakness; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4108585-00.  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 03Jan2021 (Batch/Lot number: unknown) at the age of 72 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free and second regimen subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (medically significant), outcome "unknown", described as "felt sick"; LIMB INJURY (medically significant), outcome "not recovered", described as "Injury/right shoulder"; ASTHENIA (medically significant) with onset Feb2021, outcome "recovered" (Feb2021), described as "Weakness". The action taken for adalimumab was dosage not changed.  The reporter considered "felt sick" related to bnt162b2. The reporter considered "weakness" not related to bnt162b2.  Reporter causality assessment for Humira with respect to events felt sick, shoulder injury and weakness was reported as no reasonable possibility and Reporter causality assessment for Pfizer BioNTech COVID-19 Vaccine (Tozinameran) with respect to events felt sick was possible, shoulder injury was not reported and weakness was reported as not related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events which cannot be fully assessed/excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Pain, Vaccination site pain
Clinical narrative: Crohn's flare up; Pain after both pfizer covid vaccinations; Pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4326321-00.  A 33 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 33 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohn's flare up"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain after both pfizer covid vaccinations"; PAIN (non-serious), outcome "not recovered", described as "Pain". The action taken for adalimumab was dosage permanently withdrawn.  The reporter's causality for the event(s) of pain after both Pfizer covid vaccinations with humira (adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of crohn's flare up and pain was not provided.   The reporter's assessment of the causal relationship of the Crohn's disease,  VACCINATION SITE PAIN, PAIN with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4327434-00.  A 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up". The action taken for adalimumab was unknown.  The reporter's causality with humira (adalimumab) for the event of Rheumatoid Arthritis flare up was not provided and probable reported with Pfizer Biontech COVID-19 Vaccine (tozinameran).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event RHEUMATOID ARTHRITIS and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis symptoms returned/flares; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 22K-163-4319170-00.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Dec2021, outcome "unknown", described as "rheumatoid arthritis symptoms returned/flares". The action taken for adalimumab was temporarily withdrawn.  The reporter's assessment of the causal relationship of the [rheumatoid arthritis symptoms returned/flares] with the suspect product was not provided at the time of this report. Since passible determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: vaccine has been diluted to a regular sterile water instead of the diluent associated with the vaccine with no reported adverse events; Initial information received on 17-Mar-2022 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient who was administered Haemophilus type B (HIB) vaccine [ACT-HIB] which has been diluted to a regular sterile water (water for injection) instead of the diluent associated with the vaccine with no reported adverse events.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml dose, of suspect HIB (PRP/T) vaccine, once (with an unknown formulation, strength (standard) and route) (lot number: UJ573ABA and expiry date: 20-Sep-2022) diluted with sterile water in unknown administration site for immunization.  On an unknown date the patient was administered HIB (PRP/T) vaccine which had been diluted to a regular sterile water instead of the diluent associated with the vaccine with no reported adverse events (product preparation error) (same day latency).  Action taken was not applicable with both the suspects.  Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient that was administered ActHIB with expired diluent with no reported adverse event; Initial information received on 17-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient (unknown age and gender) who had administered HIB (PRP/T) vaccine [ACT-HIB] with expired diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect HIB (PRP/T) vaccine (strength, dose, formulation, route: unknown) (lot number: UJ423AAA: Expiry date: 07-03-2022) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event patient was administered HIB (PRP/T) [ACT-HIB] with expired diluent with no reported adverse event (expired product administered) (unknown latency).   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Medication error, Product preparation error
Clinical narrative: ACTHIB reconstituted with 0.9%NaCl; Initial information received on 18-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health care professional via call center.  This case involves a 12 months old male patient who reported acthib reconstituted with 0.9%nacl while receiving vaccine Hib (Prp/T) Vaccine [Act-Hib].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included  (Hepatitis Vaccines) for Prophylactic vaccination; Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic vaccination; and Pneumococcal Vaccine Polysacch 23V (Pneumovax) for Prophylactic vaccination.  On 17-Mar-2022, the patient received a  dose of suspect Hib (Prp/T) Vaccine at dose of 0.5ml (formulation and strength: unknown)(lot number: UJ524AA and expiry date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 17-Mar-2022, the patient reported a Act-hib reconstituted with 0.9%nacl (product preparation error) following the administration of Hib (Prp/T) Vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product preparation error.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: 11 year-old boy received an ADACEL vaccine that was then noted to have expired with no reported adverse event; Initial information received on 21-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who experienced 11 year-old boy received an adacel vaccine that was then noted to have expired with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included meningococcal vaccine a/c/y/w conj (dip tox) (Menactra) for Prophylactic vaccination.  On 21-Mar-2022, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (batch lot :U6612AA) (unknown strength and expiry date) via intramuscular route in the right deltoid for immunisation  On 21-Mar-2022 (latency: same day)the patient developed a non-serious event of 11 year-old boy received an adacel vaccine that was then noted to have expired with no reported adverse event (expired product administered) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event .  At time of reporting, the outcome was Unknown for the event .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Menactra; expired product was given to a patient with no reported adverse event; Initial information received on 23-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves an unknown age and unknown gender patient who experienced menactra; expired product was given to a patient with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect meningococcal a-c-y-w135 (d conj) vaccine (unknown strength, dosage,formulation,batch number and expiry date) via unknown route in unknown administration site for immunization  On an unknown date (latency: unknown) the patient developed a non-serious event of menactra; expired product was given to a patient with no reported adverse event (expired product administered) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 68.0
Sex: M
Vaccine: COVID19, FLU4, FLU4, TDAP, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was inadvertently administered a second dose of flu vaccine with no reported adverse event; Initial information received on 23-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 68 years old male patient who reported patient was inadvertently administered a second dose of flu vaccine with no reported adverse event while receiving vaccines influenza quadrival a-b vaccine [Fluzone Quadrivalent] and influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (boostrix); varicella zoster vaccine rge (cho) (Shingrix) and tozinameran (Pfizer Biontech Covid-19 Vaccine) for Prophylactic vaccination.  On 01-Dec-2021, the patient received an unknown dose of suspect influenza quadrival a-b vaccine (strength, formulation was unknown,  lot UT7336MA and expiry date: 30-Jun-2022) in the left deltoid in unknown administration site for prophylactic vaccination. On 02-Mar-2022, the patient received 0.7ml dose once of suspect influenza quadrival a-b high dose hv vaccine prefilled syringe (strength, formulation was unknown, lot UJ769AB and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid in unknown administration site for prophylactic vaccination.  On 02-Mar-2022 the patient inadvertently administered a second dose of flu vaccine with no reported adverse event (extra dose administered, Latency: 3 months 1 day) following the administration of influenza quadrival a-b high dose hv vaccine and influenza quadrival a-b vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (  Outcome: unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: inadvertently administered with an expired product with no reported adverse event; Initial information received on 23-Mar-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 48-year-old male patient who was inadvertently administered with an expired product of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 23-Mar-2022, the patient received a dose of 0.25 ml to 2 ml suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (frequency: once) (strength, formulation: unknown) (lot number: U6621BA and Expiration Date: 21-Mar-2022) via intramuscular route in the left deltoid for Immunization.  On 23- Mar-2022 the patient had non-serious event, "inadvertently administered with an expired product with no reported adverse event" (expired product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported, "RN requesting information regarding ADACEL PFS. The product was inadvertently administered with an expired product to an employee. Patient Information o Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines need month for age. 48 YEARS. Dosage Information o Frequency = once ONCE o Therapy Date: From = Date of immunization To = leave blank 23Mar2022 o Route = route & site INTRAMUSCULAR, LEFT DELTOID o Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test 0.25mL o Strength = standard except for Fluzone HD o Indications = Immunization or TB skin test. Event Information o Treatment ADACEL." Action taken: Not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered was stored outside Pfizer storage guidelines.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered was stored outside Pfizer storage guidelines.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Hypoaesthesia, Malaise, Peripheral swelling
Clinical narrative: Patient complained of numbness in arm of injection site. Arm looked slightly swollen and splotchy red. The nurse assisting with the clinic assessed it and decided to give him benadryl. This was 10 to 15 minutes after shot was given. Patient stated he was not feeling will, started look light headed and dizzy. As his condition did not to seem to improve after sitting down for 5 to 10 minutes and ambulance was called.  Paramedics arrived and took him to the hospital. The total time between first onset of complaint and EMTs taking patient away was between 30 to 45 minutes.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Patient complained of numbness in arm of injection site. Arm looked slightly swollen and splotchy red. The nurse assisting with the clinic assessed it and decided to give him benadryl. This was 10 to 15 minutes after shot was given. Patient stated he was not feeling will, started look light headed and dizzy. As his condition did not to seem to improve after sitting down for 5 to 10 minutes and ambulance was called.  Paramedics arrived and took him to the hospital. The total time between first onset of complaint and EMTs taking patient away was between 30 to 45 minutes.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered was stored outside Pfizer storage guidelines.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus or ringing in the ear bilaterally
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No known side effects; Expired dose of M-M-R II was administered; This spontaneous report was received from an office manager and refers to a 55-week-old female patient. No information regarding the patient's medical history, concurrent conditions and previous drug reactions or allergies was reported. Concomitant medications included sterile diluent administered with the suspected vaccine.   On 15-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) subcutaneous injection, 0.5 milliliter, (lot #S036664 was verified to be valid, expiration date reported and established to be 14-NOV-2021), administered subcutaneously for prophylaxis. The administered dose of vaccine had no previous temperature excursions. The patient had no known side effects.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; temperature excursion, with subsequent administration; This spontaneous report was received from a healthcare provider and refers to a 1-year-old female patient. There was no information regarding patient's medical history, concurrent conditions and concomitant medications provided.  On 21-MAR-2022, during 1-year well check, the patient was vaccinated with improperly stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin (rHA)) (M-M-R II) 0.5 milliliter, frequency: once, subcutaneously, lot# U006485, expiration date: 26-FEB-2023 and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, frequency: once, subcutaneously, lot# U022320, expiration date: 15-JUL-2023, both for prophylaxis(indication also reported as "1-year-well check"). The aforementioned vaccines underwent a temperature excursion of 1 degree Celsius for 7 hours (product storage error) on an unknown date before administration. On an unspecified date, there were multiple previous temperature excursions. There were no lab diagnostic studies performed. The patient did not seek medical attention. No additional adverse events were reported (no adverse event).
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Scar, Vaccination failure
Clinical narrative: Shingrix given 3/19/19 and 8/22/19. Shingles case on 2022; Shingles "light" case. Saw eye Dr.; Minimal scarring.; This case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2019, the patient received the 2nd dose of Shingrix. On 19th March 2019, the patient received the 1st dose of Shingrix. On 20th December 2021, 851 days after receiving Shingrix and 1007 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and scar. On an unknown date, the outcome of the vaccination failure and scar were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and scar to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 24-Mar-2022 Reporter's Comments: The patient self-reported this report. The patient received both doses of Shingrix and had a light case of shingles just near her eye, which got resolved in 1 or 2 weeks. The patient also had minimal scarring. The patient wanted to make sure if it was ok, thus went to eye physician and had no complications. The patient asked not to be contacted. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult given pediatric dose; adult given pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On 21st March 2022, the patient received Engerix B pediatric. On 21st March 2022, 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 Information: GSK Receipt Date: 24-Mar-2022 Reporter's Comments: The reporter did not have patient's demographic details. The reporter stated that, an adult patient was given pediatric dose of Engerix B. The reporter did not have lot number neither expiration date. The reporter consented to follow up by fax. Additional Supportive Information: The patient was given pediatric dose of Engerix B, which led to underdose and adult use of a child product. This was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR054853:Same reporter US-GLAXOSMITHKLINE-US2022AMR054854:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Psoriasis, Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS/INFLAMMATION IN THE JOINTS; INFLAMMATION LOCALIZED; DEVELOPED A COUPLE OF PATCHES OF PSORIASIS; This spontaneous report received from a patient via a company representative concerned an adult female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, and other pre-existing medical conditions included: There was no medical history reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry date were not reported) 1 total 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. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced rheumatoid arthritis/inflammation in the joints, pain/ pain aggravated/increased achiness, inflammation localized (in rib area), developed a couple of patches of psoriasis, and fatigue. Treatment medications (dates unspecified) included: etanercept. The events were resistant to topical with humira. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn. The outcome of the rheumatoid arthritis/inflammation in the joints, inflammation localized and developed a couple of patches of psoriasis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220351371-covid-19 vaccine ad26.cov2.s -Rheumatoid arthritis/inflammation in the joints The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Injection site pain
Clinical narrative: This spontaneous report received from a patient concerned an elderly male. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis, and rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ankylosing spondylitis, and rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported.The patient was recovering from injection site pain. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 59 year old male. Initial information processed along with additional information received on 25-MAR-2022. 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, intramuscular, batch number was not reported) dose, start therapy date were not reported 1 total 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.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  On an unspecified date, the patient felt fog in throat (throat discomfort) which was recovering.  In FEB-2022, the patient experienced had suspected covid-19 infection (lab test data not specified) and had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number 90000223498.; Sender's Comments: V0:20220354463- COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event has an unknown/unclear 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. Therefore, this event is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: she did not feel like herself; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she did not feel like herself) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (she did not feel like herself). At the time of the report, FEELING ABNORMAL (she did not feel like herself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-523632 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I have asthma, & every time I get a cold, it goes into bronchitis, even borderline pneumonia. Since I've gotten all 3 doses, I haven't experienced that,Booster dose Oct 2021; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (I have asthma, & every time I get a cold, it goes into bronchitis, even borderline pneumonia. Since I've gotten all 3 doses, I haven't experienced that,Booster dose Oct 2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Bronchitis and Cold. Concurrent medical conditions included Asthma.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (I have asthma, & every time I get a cold, it goes into bronchitis, even borderline pneumonia. Since I've gotten all 3 doses, I haven't experienced that,Booster dose Oct 2021). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (I have asthma, & every time I get a cold, it goes into bronchitis, even borderline pneumonia. Since I've gotten all 3 doses, I haven't experienced that,Booster dose Oct 2021) outcome was unknown.            No concomitant medication reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromise patient received lower authorized dose volume; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromise patient received lower authorized dose volume) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromise patient received lower authorized dose volume). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromise patient received lower authorized dose volume) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Pharmacist informed that the patient did not receive their primary series or booster dose of Moderna COVID-19 vaccine at their pharmacy.  No treatment medications were reported.   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Heart rate increased, Hypoaesthesia, Paraesthesia
Clinical narrative: Approximately 20 minutes after delivery, I experienced transient increased heart rate and numbness/tingling in the left side of my face. Within 24 hours I began experiencing very strong tinnitus in both ears. The sensations included tones as well as hissing. The intensity of tones eventually became less pronounced after about a month. The hissing remains still after almost 1 year. I sought medical attention for these symptoms but there has been no effective treatment.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Approximately 20 minutes after delivery, I experienced transient increased heart rate and numbness/tingling in the left side of my face. Within 24 hours I began experiencing very strong tinnitus in both ears. The sensations included tones as well as hissing. The intensity of tones eventually became less pronounced after about a month. The hissing remains still after almost 1 year. I sought medical attention for these symptoms but there has been no effective treatment.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Decreased appetite, Injection site pain, Pyrexia
Clinical narrative: Fever, chills, dizziness, lack of appetite, pain at injection site, confusion.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, COVID-19, Cardiac flutter, Cerebral infarction, Chest X-ray normal
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/22/2021.  37 y/o with PMHX HTN, Asthma, DM2, anxiety and TIA x2 presents to ED sent by PCP for subacute infarct of parietal lobe (left MCA territory) on CT brain.  Pt reports he initially felt light-headed, confused, flutter in chest and occipital HA and feeling out of it after Jujitsu class.  Pt had some expressive aphasia which he attributed to work out but when it was still present the following day, pt went to PCP and had stat CT Brain.  CXR negative.  Room air sat 100%.  Afebrile.  Pt scheduled for TEE with possible loop recorder placement, pre procedure Covid test positive.  No current treatment at this time.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head abnormal, Confusional state, Dizziness, Feeling abnormal, Headache
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/22/2021.  37 y/o with PMHX HTN, Asthma, DM2, anxiety and TIA x2 presents to ED sent by PCP for subacute infarct of parietal lobe (left MCA territory) on CT brain.  Pt reports he initially felt light-headed, confused, flutter in chest and occipital HA and feeling out of it after Jujitsu class.  Pt had some expressive aphasia which he attributed to work out but when it was still present the following day, pt went to PCP and had stat CT Brain.  CXR negative.  Room air sat 100%.  Afebrile.  Pt scheduled for TEE with possible loop recorder placement, pre procedure Covid test positive.  No current treatment at this time.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 03/22/2021.  37 y/o with PMHX HTN, Asthma, DM2, anxiety and TIA x2 presents to ED sent by PCP for subacute infarct of parietal lobe (left MCA territory) on CT brain.  Pt reports he initially felt light-headed, confused, flutter in chest and occipital HA and feeling out of it after Jujitsu class.  Pt had some expressive aphasia which he attributed to work out but when it was still present the following day, pt went to PCP and had stat CT Brain.  CXR negative.  Room air sat 100%.  Afebrile.  Pt scheduled for TEE with possible loop recorder placement, pre procedure Covid test positive.  No current treatment at this time.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 3/2/2022 Noticed 25 cent size redness at injection site along with soreness at injection site 3/4/2022 Noticed the redness was now larger 4in x 2 3/4 inches in size, although the soreness was much less
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Muscle spasms, Pain, Pain in extremity
Clinical narrative: Diarrhea. Very loose watery stools and cramping. Mild soreness in the arms, fatigue, aches but primarily the diarrhea has been the worst. I am still experiencing chronic diarrhea and have yet to have a normal stool. I do not have this problem.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated and boosted. COVID-19 infection breakthrough
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus was the adverse event that began on 3/24/2021. Steady, high-pitched ringing/whine. Quite noticeable when surroundings were quiet and when I was in bed with foam earplugs; noticeable but could ignore it during the day. Continued unabated for nearly 1 year until 3/20/22 (or so. could be off by a day or 2). Suddenly, I was awoken in the middle of the night by a ping in left ear, followed by a complete and very noticeable cessation of ringing in that left ear. Right ear is still ringing as before. This is not technically an adverse event, but I wanted to report the cessation of the side effect in one ear.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears. Has not stopped. Did not report originally as a side effect because did not think was related but did report to my dr
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Hypoacusis, Magnetic resonance imaging, Sudden hearing loss
Clinical narrative: Sudden partial hearing loss in left ear.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac stress test, Cardioversion, Chest pain, Dyspnoea
Clinical narrative: Symptoms were shortness of breath that exacerbated upon exercise, and mild chest pain. The diagnosis was atrial fibrillation. I was prescribed Xarelto 20mg daily, diltiazem 240mg daily. I went to my GP and he sent me to the cardiologist listed. I went about a month of two with those meds and then he added valsartan 80mg daily, and flecainide 50mg 3xday. Those are what I'm currently taking now. And I still have the atrial fibrillation, it didn't resolve. The symptoms resolved when I started the meds in December.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Echocardiogram
Clinical narrative: Symptoms were shortness of breath that exacerbated upon exercise, and mild chest pain. The diagnosis was atrial fibrillation. I was prescribed Xarelto 20mg daily, diltiazem 240mg daily. I went to my GP and he sent me to the cardiologist listed. I went about a month of two with those meds and then he added valsartan 80mg daily, and flecainide 50mg 3xday. Those are what I'm currently taking now. And I still have the atrial fibrillation, it didn't resolve. The symptoms resolved when I started the meds in December.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Prolonged tinnitus primarily in left ear. Continuous occurrence seeming to coincide with administration of second dose of COVID-19 vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: ADMITTED TO HOSPITAL, STILL CURRENTLY ADMITTED
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, COVID-19, Cough, Diarrhoea, Nausea
Clinical narrative: cough, abd pain, n/v, diarrhea
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: cough, abd pain, n/v, diarrhea
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Back pain, Blood creatinine increased, Blood potassium decreased
Clinical narrative: PT presents to the Hospital Emergency Department with complaints of chest pain that started a few hours prior to presentation to the emergency department. The chest pain is in the middle of his chest and radiates to his back.. He is a current everyday smoker. Chest x-ray showed no acute process. A CT angiogram of the chest did reveal pulmonary embolus in the segmental branch in the the medial right lower lobe. He also tested positive for COVID-19. He was started on a heparin drip  Patient was found to be hypokalemic on admission at 3.0, after 40 mEq potassium patient's potassium increased to 3.3. Additional labs reveal creatinine currently 1.4 from baseline 1.0.  Patient continued to do well with only complaint being cough associated with chest pain. Decision to discharge patient was made. Decision to place patient on Eliquis was made.