chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 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: "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication taken in 2 weeks. Patient received paxlovid treatment start date: 02Oct2022 and stop date: 06Oct2022 for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL3427), on 10Feb2021 as dose 2, single (Lot number: EM9810) and on 13Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 69 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 as dose 4 (booster), single (Lot number: 042121A) and on 23Sep2022 as dose 5 (booster), single (Lot number: AS7162B), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RALOXIFENE (Aurobundo). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 and was treated with Paxlovid, treatment start date: 01Oct2022 to treatment stop date: 06Oct2022.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
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 (consumer or other non-HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 at 12:00 as DOSE 4 (BOOSTER), single (batch/lot number: unknown) at the age of 70 years, administered in the left arm for COVID-19 immunization; 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 immunization. The patient's relevant medical history included: "Lichen planus" (unspecified if ongoing), notes: in hair. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19." The patient underwent the following laboratory tests and procedures: Covid-19 test (SARS-CoV-2 test): Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 2 (initial pfizer dose), single (Lot number: FJ8762) at the age of 46 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Feb2021 as dose 1, single (Lot number: 030M20A), in left arm and on 12Mar2022 as dose 3, single (Lot number: 032M20A), in left arm 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (06Oct2022) Negative, notes: I was tested negative using an in-home kit on 06Oct and 07Oct, respectively; (07Oct2022) Negative, notes: I was tested negative using an in-home kit on 06Oct and 07Oct, respectively; (12Oct2022) Positive, notes: I was tested positive again on 12Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medication in 2weeks. The patient received Paxlovid for the treatment of COVID-19 from 02Oct2022 to 07Oct2022.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 2 (initial pfizer dose), single (Lot number: FJ8762) at the age of 46 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Feb2021 as dose 1, single (Lot number: 030M20A), in left arm and on 12Mar2022 as dose 3, single (Lot number: 032M20A), in left arm 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (06Oct2022) Negative, notes: I was tested negative using an in-home kit on 06Oct and 07Oct, respectively; (07Oct2022) Negative, notes: I was tested negative using an in-home kit on 06Oct and 07Oct, respectively; (12Oct2022) Positive, notes: I was tested positive again on 12Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive any other medication in 2weeks. The patient received Paxlovid for the treatment of COVID-19 from 02Oct2022 to 07Oct2022.   Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, 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) (Physician). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 17:30 as dose 5 (booster), single (Lot number: gh9694) at the age of 61 years, in right 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 was not reported. Concomitant medication(s) included: ATENOLOL, start date: 01Oct2014, stop date: 12Oct2022. Past drug history included: Tetracycline, reaction(s): "Known allergies: tetracycline", notes: Known allergies: tetracycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2, BNT162B2 OMI BA.4-5 to the reported drug ineffective / COVID-19 cannot be ruled out
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19; COVID 19; interchange of vaccines products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2,single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) in 2 weeks included: CHOLESTROL, start date: Sep2022, stop date: Oct2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Sep2022, outcome "unknown", described as "interchange of vaccines products"; 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, suspected covid-19 (start date: Sep2022, Stop date: Oct2022).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3246), on 27Jan2021 as dose 2, single (Lot number: EL3246), on 23Aug2021 as dose 3 (booster), single (Lot number: FC3180) and on 04Feb2022 as dose 4 (booster), single (Lot number: FL3209) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 22Aug2022, outcome "unknown", COVID-19 (medically significant) with onset 22Aug2022, outcome "recovered" and all described as "COVID-19 ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Aug2022) Positive, notes: she had covid on 22Aug2022, tested positive. The clinical course was reported as follows:  on 22Aug2022 of this year, she tested positive for COVID-19. For 19 days, she tested positive, and she is calling to find out how long she will be protected and when can she get the booster dose. So, I have all of the dates of the doses that she received. Her first dose, and they are all Pfizer COVID-19 Vaccines. First dose was 08Jan2021 with LOT# EL3246. Her second primary dose was 27Jan2021 with LOT# EL3246. Her first booster dose was 23Aug2021 and the LOT# is FC3180 and her second booster, the last booster was 04Feb2022 this year and that would be LOT# was FL3209 and like I mentioned, on 22Aug2022 she tested positive after this. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Palpitations, Paraesthesia
Clinical narrative: light headedness; feelings of almost fainting; tingling in my right arm; pounding heart / sometimes my heart felt like it was in my throat that was taking my breath away; occasional chest pain; sometimes my heart felt like it was in my throat that was taking my breath away; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 31-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: FA9091) for covid-19 immunisation. The patient's relevant medical history included: "Schizoaffective disorder" (unspecified if ongoing). Concomitant medication(s) included: TETANUS VACCIN taken for immunisation, in Aug2022 as dose number unknown, single; OLANZAPINE taken for schizoaffective disorder. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "light headedness"; PRESYNCOPE (non-serious), outcome "unknown", described as "feelings of almost fainting"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in my right arm"; PALPITATIONS (non-serious), outcome "unknown", described as "pounding heart / sometimes my heart felt like it was in my throat that was taking my breath away"; CHEST PAIN (non-serious), outcome "unknown", described as "occasional chest pain"; DYSPNOEA (non-serious), outcome "unknown", described as "sometimes my heart felt like it was in my throat that was taking my breath away". The events "light headedness", "feelings of almost fainting", "tingling in my right arm", "pounding heart / sometimes my heart felt like it was in my throat that was taking my breath away", "occasional chest pain" and "sometimes my heart felt like it was in my throat that was taking my breath away" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter assessed the events as non-serious. The patient was wondering if it was safe for me to get the COMIRNATY bivariant COVID-19 vaccine given my past experience of heart symptoms. The patient went to the Emergency room but there was no specified treatment. Within in 4 weeks of suspect vaccination the patient received tetanus shot and patient wanted to know if he has to wait before get the COVID bivalent vaccine.  Follow-Up (14Oct2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: light headedness; feelings of almost fainting; tingling in my right arm; pounding heart / sometimes my heart felt like it was in my throat that was taking my breath away; occasional chest pain; sometimes my heart felt like it was in my throat that was taking my breath away; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 31-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: FA9091) for covid-19 immunisation. The patient's relevant medical history included: "Schizoaffective disorder" (unspecified if ongoing). Concomitant medication(s) included: TETANUS VACCIN taken for immunisation, in Aug2022 as dose number unknown, single; OLANZAPINE taken for schizoaffective disorder. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "light headedness"; PRESYNCOPE (non-serious), outcome "unknown", described as "feelings of almost fainting"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in my right arm"; PALPITATIONS (non-serious), outcome "unknown", described as "pounding heart / sometimes my heart felt like it was in my throat that was taking my breath away"; CHEST PAIN (non-serious), outcome "unknown", described as "occasional chest pain"; DYSPNOEA (non-serious), outcome "unknown", described as "sometimes my heart felt like it was in my throat that was taking my breath away". The events "light headedness", "feelings of almost fainting", "tingling in my right arm", "pounding heart / sometimes my heart felt like it was in my throat that was taking my breath away", "occasional chest pain" and "sometimes my heart felt like it was in my throat that was taking my breath away" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter assessed the events as non-serious. The patient was wondering if it was safe for me to get the COMIRNATY bivariant COVID-19 vaccine given my past experience of heart symptoms. The patient went to the Emergency room but there was no specified treatment. Within in 4 weeks of suspect vaccination the patient received tetanus shot and patient wanted to know if he has to wait before get the COVID bivalent vaccine.  Follow-Up (14Oct2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata, Imaging procedure
Clinical narrative: Induction of alopecia areata after COVID-19 vaccination/patchy hair loss started on the bitemporal and occipital scalp the day following her first dose of the BNT162b2 vaccine; This is a literature report for the following literature source:   A 57-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (batch/lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetes" (ongoing); "psoriasis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ALOPECIA AREATA (medically significant), outcome "recovering", described as "Induction of alopecia areata after COVID-19 vaccination/patchy hair loss started on the bitemporal and occipital scalp the day following her first dose of the BNT162b2 vaccine". The events "induction of alopecia areata after covid-19 vaccination/patchy hair loss started on the bitemporal and occipital scalp the day following her first dose of the bnt162b2 vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: trichoscopic image: yellow dots, black dots, notes: vellus hairs, and thin arborizing vessels are observed in a single alopecia patch. Therapeutic measures were taken as a result of alopecia areata. The patches progressed to 50% scalp involvement despite initial treatment of systemic triamcinolone 40 mg/ml injections. 95% of regrowth was observed within eight months of initial visit with mini-pulse systemic dexamethasone, Clobetasol solution, and oral minoxidil.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events "ALOPECIA AREATA " and the suspect drug 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.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Investigation, SARS-CoV-2 antibody test, Throat irritation, Tryptase
Clinical narrative: Throat itching after second fractional dose of 0.1 mL; regardless of their first dose vaccine, received the Pfizer mRNA COVID-19 vaccine in incremental doses at 30-minute intervals to a cumulative dose of 0.3 mL; This is a literature report for the following literature source(s):   A 68-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 included: "Asthma" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing); "shellfish" (unspecified if ongoing); "peanut allergy" (unspecified if ongoing); "anaphylactic reaction" (unspecified if ongoing), notes: Shrimp, peanut. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE), for COVID-19 immunisation, reaction(s): "Hypersensitivty reaction". The following information was reported: THROAT IRRITATION (medically significant), outcome "recovered", described as "Throat itching after second fractional dose of 0.1 mL"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown", described as "regardless of their first dose vaccine, received the Pfizer mRNA COVID-19 vaccine in incremental doses at 30-minute intervals to a cumulative dose of 0.3 mL". The patient underwent the following laboratory tests and procedures: Antibody test: Unknown result, notes: We compared COVID-19 spike antibody levels before and after administration of the vaccine using graded vaccine dosing; Vaccine excipient test: Negative, notes; SARS-CoV-2 antibody test: Unknown results, notes: measured at least 2 weeks after the procedure; notes: Unit: AU/mL; Negative, notes: less than 50 Unit: AU/mL; Tryptase: 6.4 ug/L. Therapeutic measures were taken as a result of throat irritation.  Additional information: Throat itching after second fractional dose of 0.1 mL. Resolved with diphenhydramine after which protocol was continued.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be 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-PV202200075520 Same article/drug/event and different patient;US-PFIZER INC-202201218786 Same article/event/ patient and different dose;
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Throat itching after second fractional dose of 0.1 mL; regardless of their first dose vaccine, received the Pfizer mRNA COVID-19 vaccine in incremental doses at 30-minute intervals to a cumulative dose of 0.3 mL; This is a literature report for the following literature source(s):   A 68-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 included: "Asthma" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing); "shellfish" (unspecified if ongoing); "peanut allergy" (unspecified if ongoing); "anaphylactic reaction" (unspecified if ongoing), notes: Shrimp, peanut. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE), for COVID-19 immunisation, reaction(s): "Hypersensitivty reaction". The following information was reported: THROAT IRRITATION (medically significant), outcome "recovered", described as "Throat itching after second fractional dose of 0.1 mL"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown", described as "regardless of their first dose vaccine, received the Pfizer mRNA COVID-19 vaccine in incremental doses at 30-minute intervals to a cumulative dose of 0.3 mL". The patient underwent the following laboratory tests and procedures: Antibody test: Unknown result, notes: We compared COVID-19 spike antibody levels before and after administration of the vaccine using graded vaccine dosing; Vaccine excipient test: Negative, notes; SARS-CoV-2 antibody test: Unknown results, notes: measured at least 2 weeks after the procedure; notes: Unit: AU/mL; Negative, notes: less than 50 Unit: AU/mL; Tryptase: 6.4 ug/L. Therapeutic measures were taken as a result of throat irritation.  Additional information: Throat itching after second fractional dose of 0.1 mL. Resolved with diphenhydramine after which protocol was continued.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be 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-PV202200075520 Same article/drug/event and different patient;US-PFIZER INC-202201218786 Same article/event/ patient and different dose;
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Disturbance in attention, Feeling abnormal, Feeling hot
Clinical narrative: experienced 102.5F fever/fever; arthritic joint pain; muscles aches; nausea; brain fog; could not concentrate; excruciatingly sore arm; headache; was a bit warm; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003638.  A female patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: FF2589) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "experienced 102.5F fever/fever"; ARTHRALGIA (non-serious), outcome "unknown", described as "arthritic joint pain"; MYALGIA (non-serious), outcome "unknown", described as "muscles aches"; NAUSEA (non-serious), outcome "unknown"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "could not concentrate"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "excruciatingly sore arm"; HEADACHE (non-serious), outcome "unknown"; FEELING HOT (non-serious), outcome "unknown", described as "was a bit warm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient thought she was going to die.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association the causal association of suspect drug BNT162b2  and for reported events-Pyrexia, Arthralgia, Nausea, Feeling hot, headache, disturbance in attention cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: experienced 102.5F fever/fever; arthritic joint pain; muscles aches; nausea; brain fog; could not concentrate; excruciatingly sore arm; headache; was a bit warm; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003638.  A female patient received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: FF2589) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "experienced 102.5F fever/fever"; ARTHRALGIA (non-serious), outcome "unknown", described as "arthritic joint pain"; MYALGIA (non-serious), outcome "unknown", described as "muscles aches"; NAUSEA (non-serious), outcome "unknown"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "could not concentrate"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "excruciatingly sore arm"; HEADACHE (non-serious), outcome "unknown"; FEELING HOT (non-serious), outcome "unknown", described as "was a bit warm". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient thought she was going to die.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association the causal association of suspect drug BNT162b2  and for reported events-Pyrexia, Arthralgia, Nausea, Feeling hot, headache, disturbance in attention cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: long COVID; long COVID; 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), 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 (medically significant) with onset Feb2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Feb2021, outcome "not recovered" and all described as "long COVID".  Additional information: The patient had long COVID and hadn't had taste or smell since Feb2021.  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: Feeling abnormal
Clinical narrative: I've had a strange feeling in my head for the past year. Best way to describe it I feel like i'm under water; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I've had a strange feeling in my head for the past year. Best way to describe it I feel like i'm under water".  Additional information: Patient received all 3 Pfizer vaccines. Patient had a strange feeling in head for the past year, best way to describe it feel like patient was under water. Been to several doctors and can't explain why or give a remedy. There are a lot of people on line that have the same symptoms. All had their shots, all seem to think like patient do that it's the result of the vaccine. Ptient know that there has not been enough studies, but with people being concerned that the probability of this feeling could be the result.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid twice and have been hospitalized; Covid twice and have been hospitalized; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "114 brain surgeries" (unspecified if ongoing); "brain bolt" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "Covid twice and have been hospitalized". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: Covid twice and have been hospitalized; Covid twice and have been hospitalized; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "114 brain surgeries" (unspecified if ongoing); "brain bolt" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "Covid twice and have been hospitalized". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID infection/ I received the Pfizer COVID vaccine in Feb2021 and Mar2021 and boosters in Oct2021 and May2022; COVID infection/ I received the Pfizer COVID vaccine in Feb2021 and Mar2021 and boosters in Oct2021 and May2022; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "Post hemithyroidectomy [thyroid cancer]" (unspecified if ongoing), notes: Post hemithyroidectomy [thyroid cancer]. Concomitant medication(s) included: SYNTHROID taken for thyroid cancer, start date: 1970. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID infection/ I received the Pfizer COVID vaccine in Feb2021 and Mar2021 and boosters in Oct2021 and May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Aug2022) Unknown results; (01Sep2022) Unknown results; (2022) Negative, notes: Tested positive after testing negative; (2022) Positive, notes: Tested positive after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid treatment for Covid-19.  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 known drug safety profile, there is reasonable possibility of causal association between the events (DRUG INEFFECTIVE, COVID-19) and BNT162B2.
Sex: U
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). The reporter is the patient.  A patient (no qualifiers provided) received 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), outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: While in the I contracted COVID-19 and was sent home with a positive COVID-19 test.  Clinical Course: The patient received Pfizer COVID-19 vaccines two doses (at the time not ready to get a booster vaccine). While in the withheld patient contracted COVID-19 and was sent home with a positive COVID-19 test, which lasted for 12 days and the worse illness patient ever had, did not think patient would ever recover, but because had Pfizer vaccines patient did recover.  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: Fatigue, Feeling abnormal, Nasal congestion
Clinical narrative: she did not feel that great (congestion, tired); she did not feel that great (congestion, tired); she did not feel that great (congestion, tired); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 40's 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'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: FEELING ABNORMAL (non-serious), NASAL CONGESTION (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "she did not feel that great (congestion, tired)". 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.  Additional Information: The patient was in her mid 40s. The patient did not feel that great (congestion, tired) after her Pfizer bivalent booster. It was reported by patient neighbor.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The patient was actually diagnosed with Covid-19 later the same day; The patient was actually diagnosed with Covid-19 later the same day; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), 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 (medically significant), COVID-19 (medically significant) all with onset 01Oct2022, outcome "unknown" and all described as "The patient was actually diagnosed with Covid-19 later the same day". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2022) Positive, notes: The patient was actually diagnosed with Covid-19 later the same day.  Clinical course: On 01Oct2022 after approximately 4 hours after vaccination with Covid-19 Bivalent Vaccine, patient experienced fever, dyspnea, and myalgias. The patient was diagnosed with Covid-19 later the same day. Optional Information was none. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between  all  the reported events Drug ineffective , Covid 19 and the suspect drug cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Brain Fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Nov2021 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, SINGLE), administration date: Mar2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: Apr2021, for COVID-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain Fog". 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: Rash macular
Clinical narrative: red spots on the inside of his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), on 12Oct2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hand surgery" (unspecified if ongoing), notes: Her husband had a surgery before on that same hand. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 immunization. The following information was reported: RASH MACULAR (non-serious) with onset 12Oct2022, outcome "unknown", described as "red spots on the inside of his arm".  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: Feeling abnormal
Clinical narrative: I've had a strange feeling in my head for the past year. Best way to describe it I feel like i'm under water; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "I've had a strange feeling in my head for the past year. Best way to describe it I feel like i'm under water". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I've had a strange feeling in my head for the past year. Best way to describe it I feel like i'm under water".  Additional information: Description of event: The patient received all 3 Pfizer vaccines.The patient described as 'I have had a strange feeling in his head for the past year. Best way to describe it I feel like I am under water'.The patient had been to several doctors and can't explained why or give a remedy.There were a lot of people on line that had the same symptoms. All had their shots, all seem to think like the patient had that it's the result of the vaccine.The patient knew that there has not been enough studies, but with people being concerned that the probability of this feeling could be the result.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 0.42
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: administer only the liquid portion of PENTACEL and not the Hib portion with no adverse event; administer only the liquid portion of PENTACEL and not the Hib portion with no adverse event; Initial information received on 06-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 5 months old female patient who was administered only the liquid portion of pentacel and not the hib portion with no adverse event of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine and pneumococcal vaccine both for Immunisation.  On 02-Sep-2022, the patient received suspect diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine at a dose of 0.5 ml (strength, form, lot number, expiry date: not reported) via intramuscular route in unknown administration site for immunisation.  On 02-Sep-2022 the patient was administered only the liquid portion of pentacel and not the hib portion with no adverse event (single component of a two-component product administered, product preparation error, latency: same day) following the administration of diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  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.