chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Gout; Pneumonia; My back snapped; The initial case was missing the following minimum criteria: ICH-Unspecified product. Upon receipt of follow-up information on 27Feb2023, 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). The reporter is the patient.  A 93-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 92 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01), administration date: 27Jan2021, when the patient was 92-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: BACK INJURY (prolonged hospitalization) with onset 2021, outcome "unknown", described as "My back snapped"; PNEUMONIA (prolonged hospitalization, disability) with onset 01Oct2021, outcome "recovered"; GOUT (prolonged hospitalization) with onset 20Oct2021, outcome "not recovered". The patient prolonged hospitalization for pneumonia, gout, back injury (start date: 08Sep2021, discharge date: 15Dec2021, hospitalization duration: 99 day(s)). Therapeutic measures were taken as a result of pneumonia, back injury. Therapeutic measures were not taken as a result of gout.  Clinical course: The patient spent 99 days in the hospital, about 3 weeks later he had the pneumonia and about 3 weeks later he came down with gout in his left foot. About 3 weeks later, 2 therapist were working with him. They had him lean over backward his back snapped. He yelled. They told him to do it again, and he yelled again. They then told him not do that one (unclear). He was fitted with a brace which he has to wear until 01Jun2022. No surgery needed due to the events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300086167 same patient/vaccine, different dose/events;
Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back injury, Gout, Pneumonia
Clinical narrative: Gout; Pneumonia; My back snapped; The initial case was missing the following minimum criteria: ICH-Unspecified product. Upon receipt of follow-up information on 27Feb2023, 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). The reporter is the patient.  A 93-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 92 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01), administration date: 27Jan2021, when the patient was 92-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: BACK INJURY (prolonged hospitalization) with onset 2021, outcome "unknown", described as "My back snapped"; PNEUMONIA (prolonged hospitalization, disability) with onset 01Oct2021, outcome "recovered"; GOUT (prolonged hospitalization) with onset 20Oct2021, outcome "not recovered". The patient prolonged hospitalization for pneumonia, gout, back injury (start date: 08Sep2021, discharge date: 15Dec2021, hospitalization duration: 99 day(s)). Therapeutic measures were taken as a result of pneumonia, back injury. Therapeutic measures were not taken as a result of gout.  Clinical course: The patient spent 99 days in the hospital, about 3 weeks later he had the pneumonia and about 3 weeks later he came down with gout in his left foot. About 3 weeks later, 2 therapist were working with him. They had him lean over backward his back snapped. He yelled. They told him to do it again, and he yelled again. They then told him not do that one (unclear). He was fitted with a brace which he has to wear until 01Jun2022. No surgery needed due to the events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300086167 same patient/vaccine, different dose/events;
Age: 77.0
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) from product quality group. The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 10:30 as dose 5 (booster), single (Lot number: GJ6655) at the age of 77 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 at 14:00 as dose 1, single (Lot number: EL8982), in left arm, on 25Feb2021 at 14:30 as dose 2, single (Lot number: EL9265), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 06Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Jun2018, stop date: 11Feb2023. The patient has no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures, Paxlovid from 11Feb2023 to 15Feb2023, were taken as a result of vaccination failure, covid-19.
Age: 40.0
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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 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: "Known allergies: Walnuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known allergies: tetracycline". 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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: COVID 19 treatment included Paxlovid from 14Feb2023 to 18Feb2023.  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.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Mild stroke; She got from the Vaccine booster shot; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult 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 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Mild stroke; She got from the Vaccine booster shot".  Clinical course: Pfizer Sales Representative stated, "There was a lady she didn't want me to, I told I was going to report it. she didn't want me to use her name but she just told me that a friend's of her daughter has a mild stroke. She got from the Vaccine booster shot (Clarified as Pfizer COVID-19 Vaccine booster shot). I think that, I thought she said that girl was like 21 and 22 that was a late at girl but she didn't give me any information in terms of anything, it's just the booster and she was 21, 22. Her friend told her about it." When paraphrased the concern: Pfizer Sales Representative stated, "You didn't get me anything out, the age is just 21 or 22. Female." Other Medical History and Concomitant Medication: Pfizer Sales Representative stated, "No."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine dose number=5, vaccine brand other=Modena BIV; This is a spontaneous report received from a non-contactable reporter (Consumer) from product quality group. The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 19Apr2021 as dose 2, single (Lot number: EW0153), in left arm, on 09Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 07Apr2022 at 11:15 as dose 4 (booster), single (Lot number: FP4554) at the age of 55 years, in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 06Sep2022 at 19:15 as dose 5 (booster), single (Lot number: AS714UB), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hepatitis  B carrier" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Sep2022 at 19:15, outcome "unknown", described as "vaccine dose number=5, vaccine brand other=Modena BIV"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FK9895), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: 301358A), in left arm, as dose 2, single (Lot number: EN6205), in left arm and as dose 1, single (Lot number: EL9264), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 12Oct2022 as dose 5 (booster), single (Lot number: 055F22B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: mild asthma; "meningioma" (unspecified if ongoing), notes: small meningioma; "anxiety" (unspecified if ongoing), notes: mild anxiety; "acid reflux" (unspecified if ongoing), notes: acid reflux; "chronic cough" (unspecified if ongoing), notes: Long term chronic cough. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Pfizer / BioNTech, Dose Number: 1, 2 ; Moderna, Dose Number: 3-5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: Er8727), in left leg and on 14Apr2021 as dose 2, single (Lot number: Ew0151) at the age of 62 years, in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Nov2021 as dose 3 (booster), single (Lot number: 065F21A), in left arm, on 09Apr2022 as dose 4 (booster), single (Lot number: 016J21-2A), in left arm and on 06Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levofloxacin hemihydrate, reaction(s): "Known allergies: Levofloxacin Hemihydrate". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Nov2021, outcome "not recovered", described as "Pfizer / BioNTech, Dose Number: 1, 2 ; Moderna, Dose Number: 3-5"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: Return of COVID symptoms 4 days after completing Paxlovid treatment and a positive COVID test. Therapeutic measures were taken as a result of vaccination failure, COVID-19 with Paxlovid from 17Feb2023 to 22Feb2023.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 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: "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION, start date: May1991; SYNTHROID, start date: Aug1994. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 14Feb2023 to 18Feb2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Jan2021 as dose 1, single (Lot number: 030L20A), in right arm, on 13Feb2021 as dose 2, single (Lot number: 016M20A), in right arm, on 04Nov2021 as dose 3 (booster), single (Lot number: 034D21A), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: 015321A), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "Interchange of vaccine products "; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of  COVID-19; Negative, notes: 6 negative tests; Negative, notes: 6 negative tests; Negative, notes: 6 negative tests; Negative, notes: 6 negative tests; Negative, notes: 6 negative tests; Negative, notes: 6 negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Lot number: GJ5342) for covid-19 immunisation; BNT162b2 (BNT162B2), in Jul2022 as dose 1, single (Batch/Lot number: unknown) and in Aug2022 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), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she came down with COVID 19. The clinical course was reported as follows: the patient mentioned she got a dose of the Pfizer BioNTech COVID-19 in Jul2022 and then in Aug2022 she came down with Covid. She then checks her vaccination card and confirms she had her last Pfizer Booster was in Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna Vaccine; This is a spontaneous report received from contactable reporter(s) (Other 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), on 20Sep2022 as dose 5 (booster), single (Lot number: KPCM13), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Jan2021 as dose 1, single (Lot number: 029L20A), in left arm, on 19Feb2021 as dose 2, single (Lot number: 024M20A), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: 066F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anaemia" (unspecified if ongoing); "Known allergies: sulfa based drugs" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Jan2016; VITAFUSION VITAMIN D3, start date: Jan2021; FERRASORB [ASCORBIC ACID;FERROUS BISGLYCINATE;LEVOMEFOLIC ACID;MECOBALAMIN;PYRIDOXAL PHOSPHATE], start date: Aug2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Apr2022, outcome "unknown", described as "Moderna Vaccine"; 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 (PAXLOVID).; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 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: "ASTHMA" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Lyme Disease" (unspecified if ongoing); "Celiac Disease" (unspecified if ongoing); "Ehlers Danos Syndrome" (unspecified if ongoing); "Ptsd" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 15Feb2023. Past drug history included: Naproxen, reaction(s): "Known allergies: Naproxen"; Gluten, reaction(s): "Known allergies: Gluten". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Antigen test was negative; positive, notes: antigen test positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine,  cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test negative, SARS-CoV-2 test positive
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 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's 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 negative: (unspecified date) Negative; SARS-CoV-2 test positive: (unspecified date) Positive, notes: Treatment COVID-19; (2023) Positive, notes: Covid symptoms and positive test 4 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Course of events: Patient experienced rebound Covid symptoms and positive test 4 days after negative test and no symptoms. Patent received Paxlovid (Lot number GG2523) as antiviral COVID 19 treatment from 21Feb2023 to 25Feb2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: last year she got the Pfizer injections (not verified if covid vaccines) and got the virus, Hospitalized in March for 5 days; last year she got the Pfizer injections (not verified if covid vaccines) and got the virus, Hospitalized in March for 5 days; last year she got the Pfizer injections (not verified if covid vaccines) and got the virus and now she has it again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 92-year-old female patient received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown, 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 (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2022, outcome "unknown" and all described as "last year she got the Pfizer injections (not verified if covid vaccines) and got the virus, Hospitalized in March for 5 days"; DISEASE RECURRENCE (medically significant) with onset Feb2023, outcome "unknown", described as "last year she got the Pfizer injections (not verified if covid vaccines) and got the virus and now she has it again ". The patient was hospitalized for drug ineffective, covid-19 (start date: Mar2022, hospitalization duration: 5 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Feb2023) Positive, notes: got positive result on covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence (PAXLOVID). Last year the patient got the Pfizer injections (not verified if covid vaccines) and got the virus, Hospitalized in Mar for 5 days, and nowhas it again (pertaining to covid infection). on Sunday She had runny nose, sore throat and had trouble breathing, Yesterday went to medical places, got positive result on covid test.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Wrong product administered
Clinical narrative: received booster of monovalent vaccine; Tongue numbness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 48-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "received booster of monovalent vaccine"; HYPOAESTHESIA ORAL (non-serious), outcome "recovered", described as "Tongue numbness".  Additional information: Description of Event: 48-year-old female received booster of monovalent vaccine and developed tongue numbness immediately after that last for 12 hours. No hospital, ER or physician visit needed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia areata, Immune-mediated adverse reaction, Weight
Clinical narrative: auto-immune response to vaccine; hair loss in splotches on head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROXYCHLOROQUINE; FINASTERIDE; MINOXIDIL; PYRIDOX [BIOTIN;CALCIUM PANTOTHENATE;CHLORPHENAMINE MALEATE;GLYCYRRHIZIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;TOCOPHERYL ACETATE]; HYDROCORTISONE; BETAMETHASONE DIPROPIONATE topical. The following information was reported: IMMUNE-MEDIATED ADVERSE REACTION (non-serious), outcome "unknown", described as "auto-immune response to vaccine"; ALOPECIA AREATA (non-serious), outcome "unknown", described as "hair loss in splotches on head". The events "auto-immune response to vaccine" and "hair loss in splotches on head" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  clinical course: Patient shared that he experienced auto-immune response to vaccine. This according to his dermatologist (Dr. Name withheld). He had hair loss in splotches on head.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Eyelid exfoliation, Inflammation, Pruritus, Rash
Clinical narrative: my wrists red, inflamed, itching running rash; eyelids started flaking; itching; peeling; my wrists red, inflamed, itching running rash; my wrists red, inflamed, itching running rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 71-year-old patient received BNT162b2 (BNT162B2), on 23Sep2021 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. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: EYELID EXFOLIATION (non-serious) with onset 2021, outcome "unknown", described as "eyelids started flaking"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "itching"; RASH (non-serious), ERYTHEMA (non-serious), INFLAMMATION (non-serious) all with onset 2021, outcome "unknown" and all described as "my wrists red, inflamed, itching running rash"; SKIN EXFOLIATION (non-serious) with onset 2021, outcome "unknown", described as "peeling". The events "my wrists red, inflamed, itching running rash", "eyelids started flaking", "itching" and "peeling" required physician office visit. Therapeutic measures were taken as a result of rash, eyelid exfoliation, pruritus, skin exfoliation, erythema, inflammation.  Additional information: The patient has never had allergic reaction to vaccine or anything. The patient believed in the Pfizer Covid Vaccine, had all 5 shots. About 2 weeks after 3rd (23Sep2021), eyelids started flaking, itching, peeling. A few months later, the patient's wrists red, inflamed, itching running rash. On 16May2022, the patient received 4th dose. On 14Nov2022, the patient received 5th dose. Over last 16 months, 3 dermatologists, allergy tests, multiple doctor visits. No help. 3 Steroid shot helped for about a week. Multiple cortisone topicals. Made worse. On 24Feb2023, whole face, chest, wrists HELP.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: my wrists red, inflamed, itching running rash; eyelids started flaking; itching; peeling; my wrists red, inflamed, itching running rash; my wrists red, inflamed, itching running rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 71-year-old patient received BNT162b2 (BNT162B2), on 23Sep2021 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. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: EYELID EXFOLIATION (non-serious) with onset 2021, outcome "unknown", described as "eyelids started flaking"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "itching"; RASH (non-serious), ERYTHEMA (non-serious), INFLAMMATION (non-serious) all with onset 2021, outcome "unknown" and all described as "my wrists red, inflamed, itching running rash"; SKIN EXFOLIATION (non-serious) with onset 2021, outcome "unknown", described as "peeling". The events "my wrists red, inflamed, itching running rash", "eyelids started flaking", "itching" and "peeling" required physician office visit. Therapeutic measures were taken as a result of rash, eyelid exfoliation, pruritus, skin exfoliation, erythema, inflammation.  Additional information: The patient has never had allergic reaction to vaccine or anything. The patient believed in the Pfizer Covid Vaccine, had all 5 shots. About 2 weeks after 3rd (23Sep2021), eyelids started flaking, itching, peeling. A few months later, the patient's wrists red, inflamed, itching running rash. On 16May2022, the patient received 4th dose. On 14Nov2022, the patient received 5th dose. Over last 16 months, 3 dermatologists, allergy tests, multiple doctor visits. No help. 3 Steroid shot helped for about a week. Multiple cortisone topicals. Made worse. On 24Feb2023, whole face, chest, wrists HELP.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: After getting it I got COVID 19; After getting it I got COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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), outcome "unknown" and all described as "After getting it I got COVID 19". Additional information: The patient reported, "I was told I wouldn't get COVID after getting the vaccine. I got it. Both doses. Little less than a year after getting it I got COVID 19. I had it pretty bad. For longer than the usual time for it."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Anaemia, Bacteraemia, COVID-19 pneumonia, Haemoptysis
Clinical narrative: SARS-CoV-2 pneumonia with secondary bacteremia; anemia; SARS-CoV-2 pneumonia with secondary bacteremia; hemoptysis; Initial information received on 22-Feb-2023 by health care professional regarding an unsolicited valid serious case issued from a literature article. This case is linked to cases 2023SA063143, 2023SA063145, 2023SA063146, 2023SA063147, 2023SA063148 and 2023SA063144.  This case involves a 74 years old male patient (table 1) who experienced sars-cov-2 (severe acute respiratory syndrome coronavirus 2) pneumonia with secondary bacteremia while receiving vaccines PFIZER BIONTECH COVID-19 (coronavirus 2019) VACCINE and INFLUENZA VACCINE (QUADRIVALENT).  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 PFIZER BIONTECH COVID-19 VACCINE not produced by lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect high dose INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious sars-cov-2 pneumonia with secondary bacteremia (covid-19 pneumonia) (bacteraemia) with symptoms of anemia (anaemia), hemoptysis (haemoptysis) (latency: 11 days). This event was assessed as medically significant. The patient was hospitalized for this event for 13 days.  Action taken with QUADRIVALENT INFLUENZA VACCINE (INFLUENZA VACCINE (QUADRIVALENT)) and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) 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 Reporter's causality: Related; Sender's Comments: Company comment dated 28-FEB-2023: This case involves a 74 years old male patient who experienced sars-cov-2 pneumonia with secondary bacteremia while receiving vaccine and INFLUENZA VACCINE (QUADRIVALENT). Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Cutaneous vasculitis, Thrombocytopenia
Clinical narrative: Cutaneous vasculitis; thrombocytopenia; Initial information received on 22-Feb-2023 by health care professional from regarding an unsolicited valid serious case issued from a literature article:   This case is linked to cases 2023SA063143, 2023SA063145, 2023SA063146, 2023SA063147, 2023SA063137 and 2023SA063148 (CLUSTERS).  This case involves a 75 years old male patient who experienced cutaneous vasculitis and thrombocytopenia while receiving vaccines MODERNA COVID-19 (coronavirus 2019) VACCINE and INFLUENZA VACCINE (QUADRIVALENT).  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 MODERNA COVID-19 VACCINE not produced lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious cutaneous vasculitis and thrombocytopenia (latency: 6 days).  These events were assessed as medically significant.  Action taken with QUADRIVALENT INFLUENZA VACCINE (INFLUENZA VACCINE (QUADRIVALENT)) and ELASOMERAN (MODERNA COVID-19 VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (Cutaneous vasculitis, thrombocytopenia).  At time of reporting, the outcome was Unknown for the event cutaneous vasculitis and was Unknown for the event thrombocytopenia. Reporter's causality: Related; Sender's Comments: Sanofi company comment dated 27-FEB-2023: This case involves a 75 years old male patient who experienced cutaneous vasculitis and thrombocytopenia while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT). Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Spinal epidural haematoma
Clinical narrative: Spontaneous spinal epidural hematoma; Initial information received on 22-Feb-2023 by health care professional regarding an unsolicited valid serious case issued from a literature article.  This case is linked to cases 2023SA063143, 2023SA063144, 2023SA063145, 2023SA063146, 2023SA063137 and 2023SA063148.  This case involves a 64 years old male patient (table 1) who experienced spontaneous spinal epidural hematoma while receiving vaccines MODERNA COVID-19 (coronavirus disease 2019) VACCINE and INFLUENZA VACCINE (QUADRIVALENT).  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 (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MODERNA COVID-19 VACCINE not produced by lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious spontaneous spinal epidural hematoma (spinal epidural haematoma) (latency: 3 days).  The patient was hospitalized for this event for 4 days.   Action taken with QUADRIVALENT INFLUENZA VACCINE (INFLUENZA VACCINE (QUADRIVALENT)) and ELASOMERAN (MODERNA COVID-19 VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Spontaneous spinal epidural hematoma).  At time of reporting, the outcome was Unknown for the event spontaneous spinal epidural hematoma. Reporter's causality: Related; Sender's Comments: Company comment dated 27-FEB-2023: This case involves a 64 years old male patient (table 1) who experienced spontaneous spinal epidural hematoma while receiving vaccine and INFLUENZA VACCINE (QUADRIVALENT). Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Thrombosis
Clinical narrative: Thrombosis; Initial information received on 22-Feb-2023 by health care professional following COVID-19 bivalent booster vaccination.  This case is linked to cases 2023SA063143, 2023SA063145, 2023SA063146, 2023SA063147, 2023SA063137 and 2023SA063144 (CLUSTERS).  This case involves a 62-year-old female patient (table 1) who experienced thrombosis while receiving vaccines PFIZER BIONTECH COVID-19 (corona virus 2019) VACCINE and INFLUENZA VACCINE (QUADRIVALENT).  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 high dose INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect PFIZER BIONTECH COVID-19 VACCINE not produced by lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious thrombosis (latency: 12 days). This event was assessed as medically significant.  Action taken with QUADRIVALENT INFLUENZA VACCINE (INFLUENZA VACCINE (QUADRIVALENT)) and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Thrombosis).  At time of reporting, the outcome was Unknown for the event thrombosis. Reporter's causality: Related; Sender's Comments: company comment dated 27-FEB-2023: This case involves a 62 years old female patient (table 1) who experienced thrombosis while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT). Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Fluzone QIV NP PFS reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes with no reported adverse event; product was administered to patient post excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA069463 (CLUSTER), 2023SA057733(CLUSTER) and 2023SA069771(CLUSTER).  This case involves Adult and unknown gender patient and other health professional reported that Influenza quadrival A-B vaccine [Fluzone QIV] (fluzone qiv np pfs) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes with and product was administered to patient post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date fluzone qiv np pfs reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes with no reported adverse event (product storage error) and the patient received a  dose of suspect Influenza quadrival A-B vaccine suspension for injection (lot: UT7683NA, expiry date: 30-Jun-2023) with unknown strength, dose via unknown route in unknown administration site for prophylactic vaccination, post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was 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.