chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: lost 20 pounds prior to the bivalent booster.; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient(a registered nurse, retired).  An 87-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 86 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose: , Time: unknown, Anatomical Site of injection: left arm, Route of Administration: Intramuscular, Batch/Lot number: EL9262), administration date: 24Jan2021, when the patient was 85-year-old, for COVID-19 immunization; BNT162b2 (2nd dose:, Time: unknown, Anatomical Site of injection: left arm, Route of Administration: intramuscular; , Batch/Lot number: EL9266), administration date: 14Feb2021, when the patient was 85-year-old, for COVID-19 immunization; BNT162b2 (3rd dose:, Time: unknown, Anatomical Site of injection: left arm , Route of Administration: intramuscular; , Batch/Lot number: FF8839), administration date: 02Nov2021, when the patient was 86-year-old, for COVID-19 immunization. The following information was reported: WEIGHT DECREASED (medically significant) with onset 2022, outcome "recovering", described as "lost 20 pounds prior to the bivalent booster.". The patient underwent the following laboratory tests and procedures: Weight: (2022) 24 lbs, notes: lost 24 pounds; Corrects information later in report as: states lost 6 pounds recently (as of 03Nov2022); (2022) 20 lbs, notes: lost 20 pounds prior to the bivalent booster.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Weight decreased" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: 1st vertigo episode; dizziness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 at 10:00 as dose 2, single (Lot number: ER8733) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Meniere's disease" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6207, Route of administration: Intramuscular, Vaccine administration time: 10:00 AM.), administration date: 18Mar2021, when the patient was 61-year-old, for COVID-19 immunization; Flu vaccine (In Nov2001 I had the covid vaccine and flu vaccine), administration date: Nov2001, when the patient was 42 years old, for immunization, reaction(s): "dizziness". The following information was reported: VERTIGO (non-serious) with onset May2021, outcome "unknown", described as "1st vertigo episode"; DIZZINESS (non-serious) with onset 2021, outcome "unknown".  Additional information: Patient stated that, first vertigo episode was started in May2021. Patient went 6 months with vertigo or dizziness. On an unknown date in Nov2001 patient had the Covid vaccine and flu vaccine and that afternoon patient started having dizziness about every afternoon for 4 weeks.
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: grand mal seizure; This is a spontaneous report received from contactable reporter (other HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), administration date: Dec2021, for COVID-19 immunization; Bnt162b2 (dose 2; 20 days after 2nd shot, she suffered a grand mal seizure), administration date: Dec2021, for COVID-19 immunization, reaction(s): "grand mal seizure". The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant), outcome "unknown", described as "grand mal seizure". Clinical course: The patient also received the booster and 19 to 20 days after receiving the booster, she suffered another grand mal seizure.  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: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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.,Linked Report(s) : US-PFIZER INC-PV202200096896 same reporter/patient/event, different dose;
Age: 52.0
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Nov2021 at 12:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Apr2022 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (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 Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies penicillin" (unspecified if ongoing), notes: Known allergies penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19". Therapeutic measure taken as a result of drug ineffective, covid-19 included PAXLOVID from 25Oct2022 to 30Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Dizziness, Fall, SARS-CoV-2 test
Clinical narrative: fell off my horse; I started having dizziness about every afternoon for 4 weeks; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 at 09:00 as dose 3 (booster), single (Lot number: EW0176) at the age of 62 years intramuscular for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Meniere's disease" (unspecified if ongoing), notes: other medical history: Meniere's disease; "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 08Apr2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "I am sure this started in May 2021 that I had the 1st vertigo episode.", "dizziness"; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 18Mar2021, when the patient was 61-year-old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 16Nov2021, outcome "not recovered", described as "I started having dizziness about every afternoon for 4 weeks"; FALL (non-serious) with onset Jun2022, outcome "not recovered", described as "fell off my horse". The events "i started having dizziness about every afternoon for 4 weeks" and "fell off my horse" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: On May2021, patient had the 1st vertigo episode. Then went 6 months with vertigo or dizziness. In Nov2021, patient had the covid vaccine and flu vaccine and that afternoon, started having dizziness about every afternoon for 4 weeks. Then in Dec, started 7 months feeling normal. In Jun2022, patient fell off a horse and started seeing a neurologist b/c she started having dizziness every p.m. July-Sept was fine. Then after 08Sep booster, after 36 hours on 10Sep, patient woke up at 1 am and the room was spinning.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Myalgia, Pain in extremity
Clinical narrative: Sore arm; headache; muscle aches; weakness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 at 14:45 as dose 5 (booster), single (Lot number: GJ6742) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete but manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose: 4, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Nov2022, outcome "not recovered", described as "Sore arm"; HEADACHE (non-serious) with onset 02Nov2022, outcome "not recovered"; MYALGIA (non-serious) with onset 02Nov2022, outcome "not recovered", described as "muscle aches"; ASTHENIA (non-serious) with onset 02Nov2022, outcome "not recovered", described as "weakness". Therapeutic measures were not taken as a result of pain in extremity, headache, myalgia, asthenia. Additional information: The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination and was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 09Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Statins, reaction(s): "drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient did not received other medications in 2weeks.Patient received treatment as Paxlovid for covid 19.Treatment start date is 24Oct2022 and Treatment stop date is 28Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
Age: 71.0
Sex: F
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) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FG2527) at the age of 71 years, in left arm 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 "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: I tested negative at that time but 4 days later retested positive; Positive, notes: I tested negative at that time but 4 days later retested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL0142), in arm, on 09Feb2021 as dose 2, single (Lot number: EL3247), in arm and on 30Oct2021 as dose 3 (booster), single (Lot number: 0809) at the age of 76 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Anal Cancer", start date: 2013, stop date: Aug2013, notes: Pertinent Details: Chemo/Radiation Remission; "Heart Disease", start date: 16Feb2016 (ongoing), notes: Pertinent Details: 3 stents placed; "Hypothyroid" (unspecified if ongoing); "Lipid high" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder, start date: 2016 (ongoing); CO Q10, start date: 2001; PRAVASTATIN taken for hyperlipidaemia, start date: 2001 (ongoing); PLAVIX taken for cardiac disorder, start date: 16Feb2016, stop date: 29Apr2022; SYNTHROID taken for hypothyroidism (ongoing); VITAMIN C ACID, start date: 2000; VITAMIN D NOS, start date: 2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (11Jan2021) not detected; (28Jan2021) unknown results, notes: Test Method: Nucleic Acid Amplification Test including  reverse transcription polymerase chain reaction (RT-PCR)  and transcription mediated amplification (TMA); (17Apr2022) not detected, notes: Specimen information: Nasopharynx, swab. Therapeutic measures were taken as a result of vaccination failure, covid-19 included 14Oct2022 treated with paxlovid, Will treat again week ending 28Oct2022.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got covid even after 3 shots; got covid even after 3 shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient 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; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got covid even after 3 shots".  Additional information: Thought about how she got covid even after 3 shots. But she still got the 4th shot (2nd booster) anyway.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: load-grade dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003907 (Novavax).  A female patient received BNT162b2 (BNT162B2), in Jan2021 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: DIZZINESS (non-serious) with onset Jan2021, outcome "unknown", described as "load-grade dizziness". Additional Information: It was reported on 13Oct2022, a patient started treatment on an unspecified date in Jan2021 with Pfizer BioNTech COVID-19 Vaccine dose 1 for an unspecified indication. It was reported the patient experienced load-grade dizziness after 1st vaccine Jan2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare, Inappropriate schedule of product administration, Vaccination site granuloma
Clinical narrative: First dose: 21Mar2021 and second dose: 02Apr2021; a breakout of granuloma annulare at injection site of 2nd dose; a breakout of granuloma annulare at injection site of 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 at 12:00 as dose 2, single (Lot number: ER530) at the age of 53 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: Nov2018 (ongoing). Concomitant medication(s) included: TRULICITY taken for diabetes mellitus (ongoing); METFORMIN oral taken for diabetes mellitus (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Route of administration: intramuscular, Vaccine administration time: 12:00, Lot number: EN6204, Anatomical site of injection: left arm), administration date: 21Mar2021, when the patient was 53-year-old, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Apr2021 at 12:00, outcome "unknown", described as "First dose: 21Mar2021 and second dose: 02Apr2021"; VACCINATION SITE GRANULOMA (non-serious), GRANULOMA ANNULARE (non-serious) all with onset 2021, outcome "unknown" and all described as "a breakout of granuloma annulare at injection site of 2nd dose".    Additional information: Prior to vaccination, the patient did not receive any other vaccination within the 4 weeks. The patient did not have any family medical history relevant to adverse event. The patient did not undergo any specific relevant test for thromboembolic events with thrombocytopenia. No appreciable adverse events from vaccines other than a breakout of granuloma annulare at injection site of 2nd dose. 4th booster received on 30Sep2022.
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). The reporter is the patient. Other Case identifier(s): ABBVIE-4136226.  A 46-year-old female patient received BNT162b2 (BNT162B2), 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), all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral 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 "recovering", described as "Rheumatoid arthritis flare up". The action taken for upadacitinib was unknown.  Clinical course:It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Adverse event information provided by patient related to COVID vaccine. Therapy Dates (From/to): 22Sep2022 to .  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up" with the suspect product(s) BNT162b2 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.  Causalities: The reporter's causality for the event(s) of Rheumatoid arthritis flare up with Upadacitinib was Not Provided. The reporter's causality for the event(s) of Rheumatoid arthritis flare up with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility Regulatory authority opinion was that the causality for the event(s) of Rheumatoid arthritis flare up with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided Regulatory authority opinion was that the causality for the event(s) of Rheumatoid arthritis flare up with Upadacitinib was Not Provided  Assessment Results: Pfizer BioNTech COVID-19 vaccine: Rheumatoid arthritis flare up, Market Authorization Holder (MAH). Pfizer BioNTech COVID-19 vaccine: Rheumatoid arthritis flare up, Non-Health Care Professional, Global Introspection, Possible  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the event  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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: I had all three [Pfizer] vaccines and still ended up getting Covid twice; I had all three [Pfizer] vaccines and still ended up getting Covid twice; I had all three [Pfizer] vaccines and still ended up getting Covid twice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A female patient 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; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "I had all three [Pfizer] vaccines and still ended up getting Covid twice". Clinical course: patient age was reported as 52 (unit not provided). Eye rolling feeling about getting another booster. Patient had all three Pfizer vaccines and still ended up getting Covid twice. It is nice to know that omicron is included.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Migraine, Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: Passed out two weeks after the second shots; Heart racing; Dizziness; Diagnosed with POTS; Migraines; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 22-year-old female 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: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "Passed out two weeks after the second shots"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing"; DIZZINESS (non-serious), outcome "unknown"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown", described as "Diagnosed with POTS"; MIGRAINE (non-serious), outcome "unknown", described as "Migraines". The event "diagnosed with pots" required emergency room visit. Clinical course: Passed out two weeks after the second shots. Had heart racing, dizziness. Then diagnosed with POTS in the ER at the same time. Also reported that she had migraines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. 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.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Vaccination site pain
Clinical narrative: lower back pain; injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old patient received BNT162b2 (BNT162B2), on 19May2022 at 11:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 65 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Mange symptoms of Hereditary angioedema" (ongoing); "Genetic blood disorder" (ongoing), notes: Hereditary angioedema type 1; "Hereditary angioedema type 1" (unspecified if ongoing). Concomitant medication(s) included: HAEGARDA intramuscular taken for hereditary angioedema, start date: 2018 (ongoing). Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 Vaccination; Bnt162b2 (Dose: 02), for COVID-19 Immunization, reaction(s): "like being crushed underneath a train car for 4 days". The following information was reported: VACCINATION SITE PAIN (medically significant) with onset 20May2022 at 11:00, outcome "recovering", described as "injection site pain"; BACK PAIN (medically significant) with onset 20May2022 at 11:00, outcome "recovering", described as "lower back pain".  Clinical course: The patient reported that "on 20May2022 the day after my booster; I had lower back pain and injection site pain that was extreme couldn't bend, sit or get up from any position. This was strong and disability for 5 days. Another 8 days the pain was more tolerate. At this point I feel some pain briefly for seconds some. Where in my day to day activities."  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: Intracranial pressure increased
Clinical narrative: Increased intracranial pressure; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5, Comirnaty Bivalent Vaccine), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Headaches" (unspecified if ongoing), notes: 2 month history of headaches. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for COVID-19 immunization. The following information was reported: INTRACRANIAL PRESSURE INCREASED (medically significant), 4 days after the suspect product(s) administration, outcome "unknown", described as "Increased intracranial pressure". Clinical course: The patient with 2 month history of headaches then received COVID vaccine and developed worsening headache the following day. Diagnosed with increased intracranial pressure 3 days after vaccine received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had COVID 8 months later; had COVID 8 months later; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003919.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 24Sep2021 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), SUSPECTED COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "had COVID 8 months later".  Additional information: On 19Oct2022, it was reported that a patient started treatment on 26Feb2021 with Pfizer BioNTech COVID-19 Vaccine (dose 1), 26Mar2021 with Pfizer BioNTech COVID-19 Vaccine (dose 2) and 24Sep2021 with Pfizer BioNTech COVID-19 Vaccine (dose 3) for COVID-19 immunization. It was reported the individual had COVID 8 months later, around 01Jun2022 and had a significant cough and phlegm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: did not feel well; Initial information received on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp via Center well specialty pharmacy.  This case involves Elderly male patient who experienced did not feel well while receiving vaccine INFLUENZA VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  On an unknown date the patient developed a non-serious did not feel well (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  Severity: Mild  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (did not feel well).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event did not feel well.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: didnt feel well after getting flu vaccine; Initial information received on 20-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult female patient (61.8 kg) who didn't feel well after getting flu vaccine while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VACCINIUM SPP. (CRANBERRY [VACCINIUM SPP.]); ASCORBIC ACID (VITAMIN C [ASCORBIC ACID]); COLECALCIFEROL (VITAMIN D3); SALBUTAMOL SULFATE (ALBUTEROL SULFATE HFA); and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT).  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient didn't feel well after getting flu vaccine (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (didnt feel well after getting flu vaccine).  At time of reporting, the outcome was Unknown for the event.; Sender's Comments:  SanofiPVPortal20221024000027:
Age: 20.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient that received an expired dose of Tenivac with no adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 20 years old male patient who received an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 25-Oct-2022, the patient received suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT at a dose of 0.5 ml total (lot U6852AA, expiry date: 07-Oct-2022) via intramuscular route in the left deltoid for immunization.  On 25-Oct-2022 the patient developed a non-serious patient that received an expired dose of tenivac with no adverse event (expired product administered, latency: same day).  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: 4.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Off label use
Clinical narrative: given ADACEL as a prophylaxis for a laceration with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who was given adacel as a prophylaxis for a laceration 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 CEFDINIR (OMNICEF [CEFDINIR]).  On 20-Oct-2022, the patient received 0.5 mL total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE once (lot U7626AA and expiry date: 08-Dec-2024) via intramuscular route in the left arm for prophylaxis for a laceration.  On 20-Oct-2022, (latency: same day) the patient was given adacel as a prophylaxis for a laceration with no reported adverse event (off label use).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: medication error due to a 2.5 year old male patient received Quadracel, with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 2 years old male patient who had medication error due to a 2.5 year old male patient received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) Vaccine [Quadracel], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar RA 27/3), varicella zoster vaccine live (OKA/MERCK) (Proquad) for influenza vaccine both for Prophylactic vaccination.  On 25-Oct-2022, the patient received suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) Vaccine at a dose of 0.5 ml once(lot U7526AA, expiry date: 07-Sep-2024) via intramuscular route in the left thigh for immunisation.  On 25-Oct-2022 there was medication error due to a 2.5 year old male patient received quadracel, with no reported adverse event (product administered to patient of inappropriate age, same day latency).  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: 0.25
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: fluzone qiv np being administered to a patient under 6 months of age with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old female patient who recieved fluzone qiv np being administered to a patient under 6 months of age with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Prophylactic vaccination; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination; and HIB VACCINE CONJ (OMPC) (PEDVAXHIB) for Prophylactic vaccination.  On 26-Oct-2022, the patient received 0.5 mL total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE once (formulation and strength not reported; lot UT7681LA and expiry date: 30-Jun-2023) via intramuscular route in the left thigh for prophylactic vaccination.  On 26-Oct-2022, (latency: same day) the fluzone qiv np being administered to a patient under 6 months of age with no reported adverse event (product administered to patient of inappropriate age) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  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 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: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: administered FLUZONE HD QIV instead of the FLUZONE QIV with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA447057(CLUSTER) and 2022SA446385(CLUSTER).  This case involves a 39 years old male patient who was administered fluzone hd qiv (vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE) instead of the fluzone qiv with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Oct-2022, the patient received a dose of 0.7 ml of  suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot UT7729CA, Expiration date: 30-Jun-2023, via intramuscular route in the left deltoid as Immunization.  On 19-OCT-2022 the patient was administered fluzone hd qiv instead of the fluzone qiv with no reported adverse event (wrong product administered) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was 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: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA447057(CLUSTER), 2022SA446385(CLUSTER) and 2022SA448075(CLUSTER).  This case involves a 54 years old male patient was under the age of 65 were administered influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] instead of the fluzone QIV with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 18-Oct-2022, the patient received suspect influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml once (lot UT7729CA, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 18-Oct-2022, the patient who was under the age of 65 were administered fluzone hd qiv instead of the fluzone qiv with no adverse event (wrong product administered, product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown for both the 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 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.