chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; product storage error; This spontaneous report has been received from a medical assistant concerning to a 4-years-old male patient.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 21-DEC-2022, the patient was vaccinated with an improperly dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly in the right thigh (lot#: W019628 and expiration date: 19-DEC-2023) (dose number, dose were not provided) as prophylaxis (product storage error). No additional adverse event was reported. No further information was provided.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Route of administration: IM; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 13-month-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 22-FEB-2023, the patient was vaccinated at a private doctor's office/hospital with varicella virus vaccine live (oka/merck) (VARIVAX) via intramuscular (IM) route at her right thigh (Incorrect route of product administration) as prophylaxis (lot # W006412 and expiration date 23-FEB-2024; dose not provided). It was reported that, on 20-JAN-2023, the vaccine underwent a temperature excursion in the range of 6°F to 14°F (-14°C to -10°C) for 1 hour (Product storage error).   This is one of several cases received from the same reporter.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event, Product storage error
Clinical narrative: no adverse event; Route of administration: IM; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 15-FEB-2023, the patient was vaccinated at a private doctor's office/hospital with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) via intramuscular (IM) route at her right thigh (Incorrect route of product administration) as prophylaxis (lot # W019627 and expiration date 19-DEC-2023; dose not provided). It was reported that, on 20-JAN-2023, the vaccine underwent a temperature excursion in the range of 6°F to 14°F (-14°C to -10°C) for 1 hour. No adverse event occurred.  This is one of several cases received from the same reporter.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE/PQC; Vaccine with temperature excursion administered to patient; This spontaneous report was received from a medical assistant (also reported as "vaccine provider"), referring to a 12-month-old male patient. The patients' pertinent medical history, past drug allergies/reactions and concomitant medications were not provided.      On 27-JAN-2023, the patient was vaccinated with an improperly stored dose (reported as "temperature excursion", which occurred on 20-JAN-2023) of varicella virus vaccine live (Oka/Merck) (VARIVAX) (product storage error), intramuscularly in the right thigh as prophylaxis, at private doctor's office/hospital (lot number: W006412 confirmed as valid lot number, expiration date was reported and confirmed upon internal validation as 23-FEB-2024; dose was not provided). Temperature excursion details: total time in the range 6 degrees Fahrenheit to 14 degrees Fahrenheit: 1 hour, total combine excursion time: 1 hour, 0 minutes, 0 seconds as recorded by a data logger. No adverse events reported. No PQC.  This is one of several reports received from the same reporter (original Marrs case #2303USA002114).; Sender's Comments:  US-009507513-2303USA002114:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion; This spontaneous report has been received from a medical assistant, concerning a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 31-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) subcutaneous injection (valid lot number W019627 [expiration date 19-DEC-2023 obtained per internal validation]) (dose, vaccination scheme, anatomical location, and frequency were not provided) for prophylaxis, after a temperature excursion. Total time in the range of -9 degrees Celsius (C) to 8 degrees C: 72 hours, 8 minutes. Total time at 26 degrees C or warmer: 2 hours.  Total combined excursion time: 74 hours, 8 minutes, 0 seconds (product storage error).   No additional adverse events were provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114:Original case
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; temperature excursion; This spontaneous report has been received from a medical assistant, concerning a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 30-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) subcutaneous injection, right thigh, intramuscular (valid lot number W019627 [expiration date 19-DEC-2023 obtained per internal validation]) (dose, vaccination scheme, and frequency were not provided) for prophylaxis, after a temperature excursion. Total time in the range of -9 degrees Celsius (C) to 8 degrees C: 72 hours, 8 minutes. Total time at 26 degrees C or warmer: 2 hours.  Total combined excursion time: 74 hours, 8 minutes, 0 seconds (product storage error).  ~  No additional adverse events were provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114:Original case
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Wheezing
Clinical narrative: Developed wheezing after receiving the doses of Vaxelis; This serious case was retrieved by partner on 19-APR-2023 with reference number: 02373539 and (Interaction # 02373518). The original narrative from the sender is confidential. It refers to a patient of unknown age who was treated with Vaxelis and experienced Wheezing.  Company Comment Wheezing was assessed as serious due to prolonged hospitalization.  Wheezing is unlisted for Vaxelis as per the Reference Safety Information (CCDS).  Considering the current knowledge on Vaxelis (wheezing unlisted), and that the events occurred after receiving the doses of Vaxelis on an unknown date, and lack of information in this case (medical history) and in absence of confounding factors (co-suspect vaccine) reported, and that the hospital doctor did not think that these symptoms were related to Vaxelis, the causal relationship between Vaxelis and the event Wheezing is assessed as not related.  This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Wheezing was assessed as serious due to prolonged hospitalization.  Wheezing is unlisted for Vaxelis as per the Reference Safety Information (CCDS).  Considering the current knowledge on Vaxelis (wheezing unlisted), and that the events occurred after receiving the doses of Vaxelis on an unknown date, and lack of information in this case (medical history) and in absence of confounding factors (co-suspect vaccine) reported, and that the hospital doctor did not think that these symptoms were related to Vaxelis, the causal relationship between Vaxelis and the event Wheezing is assessed as not related.  This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
Sex: M
Vaccine: COVID19
Symptoms: Leukaemia
Clinical narrative: leukemia; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ3268) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization; Bnt162b2 (Dose 2, Single), for COVID-19 immunization. The following information was reported: LEUKAEMIA (medically significant), outcome "unknown", described as "leukemia".  Clinical course: She mentioned that patient had received a primary series and the booster bivalent; then was diagnosed with Leukemia following all these vaccines. The reporter queried about the next step or if the patient needed to start all over after the patient got the primary series and booster bivalent then he got diagnosed with leukemia. The doctor has recommended the patient to start the primary series and bivalent was all over again because leukemia may have washed away the effect.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event leukemia and the use of suspect product BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be fully excluded. The case will be reassessed once further 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), at the age of 78 years in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Paxlovid was administered from 06Apr2023 to 10Apr2023 as therapeutic measure as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162B2 and BNT162b2, BNT162b2 omi ba.4-5 to the events COVID-19 and drug ineffective cannot be ruled out.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash; urticaria-diffuse; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing); "gout" (unspecified if ongoing). Concomitant medication(s) included: ALLOPURINOL; GLIPIZIDE; LISINOPRIL; FELODIPINE. Past drug history included: Hmg coa reductase inhibitors, reaction(s): "known allergies: HMG coa reductase inhibitors". Vaccination history included: Covid -19 vaccine (DOSE 3 (BOOSTER), SINGLE, Unknown manufacturer), for Covid-19 Immunization; Covid -19 vaccine (Primary Immunization Series Completed; Unknown manufacturer), for Covid-19 Immunization. The following information was reported: RASH (non-serious) with onset 24Oct2022, outcome "recovering"; URTICARIA (non-serious) with onset 24Oct2022, outcome "recovering", described as "urticaria-diffuse". The events "rash" and "urticaria-diffuse" required physician office visit. Therapeutic measures were taken as a result of rash, urticaria. Additional information:  treatment included topical, oral steroids. Covid wasn't tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: 100.0, notes: low fever 100.0. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Apr2023 to 14Apr2023.  Clinical course: The patient did not take other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported COVID-19 positive after BNT162b2, BNT162b2 omi ba.4-5 immunization is considered ineffective of BNT162b2, BNT162b2 omi ba.4-5 , and the Company cannot completely exclude the possible causality between the reported events and the suspect.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 09:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Abdominal aneurysm" (unspecified if ongoing); "atopic dermatitis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Ace inhibitors allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 09Apr2023 to 13Apr2023 for COVID-19 treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300161873 same reporter/patient, different product/events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. Clinical course: It was reported that patient took Paxlovid as COVID-19 treatment from 07Apr2023 to 12Apr2023. Other medication in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300161988 same patient, different drug, different event;
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 16:30 as dose 5 (booster), single (Lot number: GH9702) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: DESVENLAFAXINE, start date: 01Nov2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Report about covid treatment yes, Reporter type patient, vaccine received yes, other medication in 2weeks yes, Product COVID 19 Treatment start date 04Apr2023, stop date 09Apr2023. This is a notification generated from the regulatory system. As part of the simplification process, the following Complaint Records were classified as Product Use Attributes Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details. Conclusion of Previously Completed Investigation The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9702. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: A-Fib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received BNT162b2 (BNT162B2), on 03Oct2021 as dose 3 (booster), single (Lot number: 30145BA) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Breast CA", start date: Apr2004, stop date: 2005; "Bil mastectomies" (unspecified if ongoing); "lymph node dissection" (unspecified if ongoing); "reconstruction", start date: 2004 (unspecified if ongoing); "XRT + chemotherapy", start date: 2005 (unspecified if ongoing); "XRT + chemotherapy", start date: 2005 (unspecified if ongoing); "Depression", start date: 2010 (ongoing), notes: Pertinent details: Trintellix-20 mg q day, Abilify-2mg q day; "Osteopenia", start date: 2000 (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Time: Proportional 13:00 , Anatomical site: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN9581), administration date: 03Feb2021, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Time: unknown, Anatomical site: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6198), administration date: 24Feb2021, for COVID-19 immunization, reaction(s): "A-Fib". The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 2021, outcome "recovered" (2022), described as "A-Fib". Therapeutic measures were taken as a result of atrial fibrillation.  Clinical course: Patient age at time of vaccination was 68-69 years (as reported). Family medical history relevant to adverse events was None. Breast cancer pertinent details included Bil mastectomies, lymph node dissection and 2004 reconstruction. XRT + chemotherapy 2005. A-Fib onset date was Sep2021 and stop date was 2022, Pertinent details included Cardioversion x2 (2022) + cardiac ablation 2022. There was no specific relevant test for thromboembolic events with thrombocytopenia. Patient later received Dose 4 (booster), Single on 02Apr2022 (Time (24hrs): unknown, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: FK9895). Reason for booster dose was reported as due to a weakened immune system and others included age greater than 65.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 at 01:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Apr2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 29Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "T1 Diabetes" (unspecified if ongoing), notes: Other medical history: T1 Diabetes,; "Addison's disease" (unspecified if ongoing), notes: Other medical history: Addison's disease; "hypoglycemia" (unspecified if ongoing), notes: Other medical history: hypoglycemia; "CVD (mild)" (unspecified if ongoing), notes: Other medical history: CVD (mild). There were no concomitant medications. Past drug history included: Avelox, reaction(s): "Known allergies: Avelox", notes: Known allergies: Avelox. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 and treated with Paxlovid, treatment start date was 16Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: extremely ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (201253). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Vaccination, reaction(s): "extremely ill". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "extremely ill".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300073036 Same patient/event, different dose number;
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Therapeutic response unexpected
Clinical narrative: happy unexpected improvement; general fatigue; The initial case was missing the following minimum criteria: unspecified product, unspecified adverse event and unspecified number of patients. Upon receipt of follow-up information on (17Apr2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  An 84-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2022 as dose 3 (booster), single (Lot number: FF2590) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history included: "vascular dementia alzheimers and parkinsons" (unspecified if ongoing); "vascular dementia alzheimers and parkinsons" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Lot: EL3246), administration date: 07Jan2021, when the patient was 81-year-old, for COVID-19 immunization, reaction(s): "cognitive improvement", "general fatigue"; BNT162b2 (DOSE 2, SINGLE , Lot: EL3246), administration date: 28Jan2021, when the patient was 81-year-old, for COVID-19 immunization, reaction(s): "cognitive improvement", "general fatigue". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "happy unexpected improvement"; FATIGUE (non-serious), outcome "unknown", described as "general fatigue".  Additional information: This is not an adverse negative reaction but rather a positive side effect. At both initial vaccines patient (reporter's mother) experienced a (Illegible word) cognitive improvement. More alert and responsive as if to suggest an arresting of disease process. She had vascular dementia alzheimers and parkinsons. Both of which degrade overall awareness and interactive responsiveness. Beyond a pronounced general fatigue which is the understood effect of any vaccine on the body, the happy unexpected improvement which seems to occurred with any revaccination of pfizer covid vaccine. Reporter reported for the record that research may result. One or more of the chemicals or chemistry of this product could prove useful in the fight of both alzheimers and parkinsons.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: A-Fib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Lot number: EN6198) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Breast CA", start date: Apr2004, stop date: 2005; "lymph node dissection", start date: 2004 (unspecified if ongoing), notes: Bil mastectomies lymph node dissection and Reconstruction. Chemotherapy x RT 2004- 2005; "chemotherapy", start date: 2004, stop date: 2005, notes: Bil mastectomies lymph node dissection and Reconstruction. Chemotherapy x RT 2004- 2005; "Depression", start date: 2010 (ongoing), notes: Pertinent details: Trintellix-20mg 8 day, Abilify- 2mg 8 day; "Osteopenia", start date: 2000 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Time: 13:00, Site and Route of injection: Left Deltoid, Route of administration: Intramuscular, Batch/ Lot number: EN9581), administration date: 03Feb2021, for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset Sep2021, outcome "recovered" (2022), described as "A-Fib". Therapeutic measures were taken as a result of atrial fibrillation as Cardioversion x2 2022 and cardiac ablation 2022.
Sex: U
Vaccine: PNC20
Symptoms: Chills, Diarrhoea, Fatigue
Clinical narrative: extreme fatigue; diarrhea; chills; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "extreme fatigue"; DIARRHOEA (non-serious), outcome "recovered", described as "diarrhea"; CHILLS (non-serious), outcome "recovered".  Additional information: The patient experienced extreme fatigue, diarrhea, and chills for 3 days following administration of pneumococcal 20-val conj vac (dipht CRM197 protein). Event took place after use of product.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: extremely ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (201253). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "extremely ill".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300165648 Same patient/event, different dose number;
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Poor quality vaccine administered with no reported adverse event; products were not good and needed to be returned with no reported adverse event; Initial information received on 14-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves 30 patients received poor quality vaccine ACT-HIB post excursion 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 suspect hib (prp/t) vaccine Powder and solvent for solution for injection lot UJ756AAA , Expiry date: 12-Aug-2023) (strength, dose: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient had a non-serious poor quality vaccine administered with no reported adverse event (poor quality product administered), products were not good and needed to be returned with no reported adverse event (product storage error) (unknown latency) following the administration of hib (prp/t) vaccine.  Action taken was not applicable.  It was reported Nurse manager reports that 30 doses of ACTHIB and 3 doses of MENQUADFI were administered to patients post-excursion; she asks if they need to re-vaccinate their patients?  At time of reporting, the outcome was Unknown for both events.    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: 0.75
Sex: F
Vaccine: FLU3
Symptoms: Brain oedema, Local reaction
Clinical narrative: brain swelling; patient had localized reaction; Initial information received on 14-Apr-2023 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 9 months old female patient who experienced brain swelling and patient had localized reaction after receiving vaccine Influenza USP Trival A-B Subvirion Vaccine [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Oct-2003, the patient received an unknown dose (dose 1) (Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test = 0.5 ml) of suspect Influenza USP Trival A-B Subvirion vaccine Suspension for injection (Strength = standard) of lot U1102AA and expiry: Jun-2004 via unknown route in the left thigh for immunization.  On an unknown date, the patient developed a serious event brain swelling (brain oedema) (unknown latency) following the administration of Influenza USP Trival A-B Subvirion vaccine. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious event patient had localized reaction (vaccination site reaction) (unknown latency) following the administration of Influenza USP Trival A-B Subvirion vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (patient had localized reaction, brain swelling).  At time of reporting, the outcome was Unknown for the event patient had localized reaction and was Unknown for the event brain swelling.; Sender's Comments: Sanofi company comment dated 19-Apr-2023: This case involves a 9 months old female patient who experienced brain swelling and patient had localized reaction after receiving vaccine Influenza USP Trival A-B Subvirion Vaccine [Fluzone]. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: duplicate dosing of the polio vaccine form different manufacturers with no reported adverse event; Initial information on 14-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 years old female patient who had duplicate dosing of the poliomyelitis vaccine (inactivated) IPV (VERO) [IPOL] form different manufacturers with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Apr-2023, the patient received a Standard dose 3 of suspect poliomyelitis vaccine (inactivated) IPV (VERO) Suspension for injection at a dose of 0.5 mL total (lot V1B901M, expiry date- 2-Jun-2024) via unknown route in unknown administration site for Immunization.  On 13-APR-2023, (latency- same day), the patient developed a non-serious event of duplicate dosing of the polio vaccine form different manufacturers with no reported adverse event (extra dose administered) following the administration of poliomyelitis vaccine (inactivated) IPV (VERO).  Action taken was not applicable.  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.; Sender's Comments:  US-SA-2023SA120468:01576513
Age: 4.0
Sex: M
Vaccine: MMR, YF
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received YF-VAX and had received another live vaccine 8 days earlier with no reported adverse event; Initial information received on 17-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who received Yellow Fever Vaccine  [Yf-Vax] and had received another live vaccine 8 days earlier with no reported adverse event and patient also received Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Typhoid Vaccine (Typhoid) for Prophylactic vaccination.  On 20-Mar-2023, the patient received an unknown dose of suspect MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) not produced by Sanofi Pasteur (with an unknown formulation, lot number, expiry date, strength)  via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On 28-Mar-2023, the patient received 0.5 ml of suspect Yellow Fever Vaccine Solution for injection (lot number: UJ818AA; Expiry date: 18-Apr-2024) (Strength: Standard) (Frequency: once) via subcutaneous route in the left thigh for immunization.  On 28-Mar-2023, the patient received Yellow Fever Vaccine and had received another live vaccine (latency: 1 day)  earlier with no reported adverse event (inappropriate schedule of product administration) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE .   It was reported,  When not administered concomitantly, wait at least 4 weeks between administration of YF- Caller reporting a patient received YF-VAX and had received another live vaccine 8 days earlier. Caller with question on whether dose needs repeating. MMR administered on 20MAR2023 and YF-VAX administered on 28MAR2023.This situation is reported as a medication error due to not administering dose within guidelines on the PI in regard to waiting 4 weeks between administering Live vaccines.  Action taken: not applicable for both the vaccines  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: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: had administered an expired vaccine to a patient 30 minutes ago, with no reported adverse event; Initial information was received on 17-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient who reported administered an expired vaccine to a patient 30 minutes ago, with no reported adverse event after receiving diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (Suspension for injection) expiry date: 02-Apr-2023 (lot number, strength, frequency was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of had administered an expired vaccine to a patient 30 minutes ago, with no reported adverse event (expired product administered) (same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) 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: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: NONE.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 1.08
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Abdominal mass, Computerised tomogram abdomen abnormal, Magnetic resonance imaging abnormal
Clinical narrative: Abdominal mass
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Heart rate increased, Laboratory test normal
Clinical narrative: Patient started to have increased blood pressure and heart rate in the evening of the vaccination, with blood pressure 156/89 and heart rate 85 when her usual BP is 130 and HR 70. Patient went to ER and got many tests (according to patient) and beta blocker at ER. Patient also received a prescription for metoprolol tartrate 25mg to take 2 times a day for 14 days. Patient was told by ER MD that the cause is unknown but vaccination cannot be ruled out. Patient was also told by ER MD that all the labs and tests are normal and follow up with cardiologist if she does not get better.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Headache, Malaise, Nasopharyngitis
Clinical narrative: Came down with COVID while staying, on vacation. Symptoms started approx 4 days after travelling by air across country. Arrived at airport. Stayed one night in hotel before driving to ultimate destination.  COVID diagnosed here.   Received rx for Paxlovid via telephone visit with MD.  Did not see provider in person.   Symptoms: slight sore throat, sinus congestion, cough, headache.  No fever/chills.  Reminiscent of a bad cold.  No worse.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: Came down with COVID while staying, on vacation. Symptoms started approx 4 days after travelling by air across country. Arrived at airport. Stayed one night in hotel before driving to ultimate destination.  COVID diagnosed here.   Received rx for Paxlovid via telephone visit with MD.  Did not see provider in person.   Symptoms: slight sore throat, sinus congestion, cough, headache.  No fever/chills.  Reminiscent of a bad cold.  No worse.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Swollen tongue, Throat irritation, Tongue pruritus
Clinical narrative: throat and tongue intching and slight swelling of tongue.  Moderately labored breathing within 10 minutes
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Peripheral swelling, Pyrexia, Skin tightness
Clinical narrative: swelling of left arm from shoulder cap to elbow, tightening of skin and fevered body. Does not subside with compress ( warm or cold) or OTC drugs. Prednisone is currently being administered.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 10 month latter
Age: 69.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Malaise, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: The patient reported the day after receiving her immunizations her right arm developed swelling, redness, pain and was warm to the touch; pt reported being in bed for 3 days feeling ill, her PCP prescribed Cephalexin 500mg capsules to take twice daily for 10 days, she came yesterday 04/21/23 to the pharmacy and informed us and she was feeling better and her arm had improved.
Age: 69.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Skin warm
Clinical narrative: The patient reported the day after receiving her immunizations her right arm developed swelling, redness, pain and was warm to the touch; pt reported being in bed for 3 days feeling ill, her PCP prescribed Cephalexin 500mg capsules to take twice daily for 10 days, she came yesterday 04/21/23 to the pharmacy and informed us and she was feeling better and her arm had improved.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Dysgeusia, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Sore throat, congestion, achy joints, fatigue, head ache, metallic taste, sensitive to certain smells