chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Asymptomatic COVID infection/Nasal swab positive; Asymptomatic COVID infection/Nasal swab positive; This is a spontaneous report received from a contactable reporter (Physician). A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose 4 (booster), single (Lot number: GJ3274) at the age of 61 years intramuscular for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), on 12Apr2022 as dose 2, single (Lot number: EP6955) and on 09Jun2022 as dose 3 (booster), single (Lot number: FF2589), all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jan2023, outcome "recovering" and all described as "Asymptomatic COVID infection/Nasal swab positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2023) Positive, notes: Nasal swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Additional information: the reporter considered the events as non-serious. The patient did not receive other vaccines in the four weeks.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group, Program ID. The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 59 years for COVID-19 immunization; BNT162b2 (BNT162B2), on 20May2021 as dose 1, single (Lot number: EW0169), on 10Jun2021 as dose 2, single (Lot number: ER8731) and on 10Dec2021 as dose 3 (booster), single (Lot number: 330308D) for COVID-19 immunization. The patient's relevant medical history included: "COVID-19", start date: Feb2021 (unspecified if ongoing), notes: patient, his wife, and one of his twin boys; "monoclonal antibody infusion", start date: 2021, stop date: 2021. The family, (patient, his wife, and one of his twin boys) all got COVID-19 at the same time in Feb2021. Patient and his wife had the monoclonal antibody infusion. They had to wait 90 days before receiving a COVID-19 Vaccine. Patient clarified that when they had COVID-19 in Feb2021, none of them had received any COVID-19 Vaccines yet, it was prior to being vaccinated. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2022, outcome "unknown" and all described as "tested positive for COVID-19". The patient and his wife both just got over COVID-19. Both tested positive for COVID-19, he thought on 29Dec2022. The patient underwent the following laboratory tests and procedures: COVID-19: (29Dec2022) Positive; (08Jan2023) Positive, notes: around 1pm. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID from 29Dec2022 to 02Jan2023 as treatment for COVID-19.
Sex: F
Vaccine: 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 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 26Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovered" (05Jan2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I had a rebound of COVID 2 days after testing; Positive, notes: I had a rebound of COVID 2 days after testing. Therapeutic measures (Paxlovid) 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest discomfort, Dizziness, Feeling hot
Clinical narrative: my head felt on fire and I felt I was going to faint; felt I was going to faint/dizziness; developed irregular menses; vertigo; chest tightness; elevated blood pressure; palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 at 11:30 as dose 2, single (Lot number: EW0153) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Peanuts" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. Vaccination history included: BNT162b2 (dose lot number=EN6198, dose administration time=11:00 AM, dose number=1, dose vaccine location=Arm Left), administration date: 30Mar2021, when the patient was 43-year-old, for COVID-19 immunization.  The following information was reported: CHEST DISCOMFORT (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "chest tightness"; MENSTRUATION IRREGULAR (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "developed irregular menses"; BLOOD PRESSURE INCREASED (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "elevated blood pressure"; DIZZINESS (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "felt I was going to faint/dizziness"; FEELING HOT (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "my head felt on fire and I felt I was going to faint"; PALPITATIONS (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown"; VERTIGO (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling hot, dizziness, menstruation irregular, vertigo, chest discomfort, blood pressure increased, palpitations.  Additional information: Prior to vaccination the patient was not diagnosed with COVID- 19, Since the vaccination, patient has been tested for COVID-19. The patient received Tylenol within 2 weeks of vaccination. Within 20 minutes her head felt on fire and she felt she was going to faint. Since then, she developed irregular menses, vertigo, dizziness, chest tightness. Four days after she had elevated blood pressure, palpitations. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Serious: No. Hospitalization Prolonged: No.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Palpitations, SARS-CoV-2 test, Vertigo
Clinical narrative: my head felt on fire and I felt I was going to faint; felt I was going to faint/dizziness; developed irregular menses; vertigo; chest tightness; elevated blood pressure; palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 at 11:30 as dose 2, single (Lot number: EW0153) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Peanuts" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. Vaccination history included: BNT162b2 (dose lot number=EN6198, dose administration time=11:00 AM, dose number=1, dose vaccine location=Arm Left), administration date: 30Mar2021, when the patient was 43-year-old, for COVID-19 immunization.  The following information was reported: CHEST DISCOMFORT (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "chest tightness"; MENSTRUATION IRREGULAR (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "developed irregular menses"; BLOOD PRESSURE INCREASED (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "elevated blood pressure"; DIZZINESS (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "felt I was going to faint/dizziness"; FEELING HOT (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown", described as "my head felt on fire and I felt I was going to faint"; PALPITATIONS (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown"; VERTIGO (non-serious) with onset 20Apr2021 at 11:00, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling hot, dizziness, menstruation irregular, vertigo, chest discomfort, blood pressure increased, palpitations.  Additional information: Prior to vaccination the patient was not diagnosed with COVID- 19, Since the vaccination, patient has been tested for COVID-19. The patient received Tylenol within 2 weeks of vaccination. Within 20 minutes her head felt on fire and she felt she was going to faint. Since then, she developed irregular menses, vertigo, dizziness, chest tightness. Four days after she had elevated blood pressure, palpitations. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Serious: No. Hospitalization Prolonged: No.
Sex: U
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: serious neurological symptoms/insignificant ones; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTUERER UNKNOWN), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot number: unknown), for COVID-19 immunization, reaction: "serious neurological symptoms". The following information was reported: NEUROLOGICAL SYMPTOM (medically significant), outcome "unknown", described as "serious neurological symptoms/insignificant ones". Clinical course: After being extremely thankful for the amazingly quick development of the Pfizer COVID-19 vaccine, patient had ever single one, including the omicron booster. After the second shot, patient had some significant side effects, insignificant ones for two boosters, then the worst symptoms from the Omicron booster. Patient told the doctor shortly after and to patient's surprise, she said they were serious neurological symptoms and getting another would be dangerous. Patient was very concerned about COVID.  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: Neurological symptom
Clinical narrative: serious neurological symptoms; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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 (Dose 1, unknown manufacturer), for COVID-19 Immunization; Bnt162b2 (Dose 2, After the second shot, I had some significant side effects, insignificant ones for two boosters, then the worst symptoms from the Omicron booster.), for COVID-19 Immunization, reaction(s): "serious neurological symptoms"; Bnt162b2 (1st Booster, dose 3, After the second shot, I had some significant side effects, insignificant ones for two boosters, then the worst symptoms from the Omicron booster.), for COVID-19 Immunization, reaction(s): "serious neurological symptoms". The following information was reported: NEUROLOGICAL SYMPTOM (medically significant), outcome "unknown", described as "serious neurological symptoms". Clinical course: After being extremely thankful for the amazingly quick development of the Pfizer COVID-19 vaccine, patient had ever single one, including the omicron booster. After the second shot, patient had some significant side effects, insignificant ones for two boosters, then the worst symptoms from the Omicron booster. Patient told the doctor shortly after and to patient's surprise, doctor said they were serious neurological symptoms and getting another would be dangerous. Patient was very concerned about COVID.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300005067 same reporter/pt/event, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: serious neurological symptoms/the worst symptoms from the Omicron booster; This is a spontaneous report received from a contactable consumer (patient). A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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 (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Bnt162b2 (Dose 2, After the second shot, patient had some significant side effects), for Covid-19 immunization, reaction(s): "serious neurological symptoms"; Bnt162b2 (Dose 3 (1st boosters), Insignificant ones for two boosters), for COVID-19 immunization, reaction(s): "serious neurological symptoms"; Bnt162b2 (Dose 4 (2nd boosters), Insignificant ones for two boosters), for Covid-19 immunization, reaction(s): "serious neurological symptoms". After being extremely thankful for the amazingly quick development of the Pfizer COVID-19 vaccine, patient had ever single one, including the omicron booster. After the second shot, patient had some significant side effects, insignificant ones for two boosters, then the worst symptoms from the Omicron booster. Patient told doctor shortly after and to his/her surprise, she (the doctor) said they were serious neurological symptoms and getting another would be dangerous. Patient's very concerned about COVID so he/she wondered if there are any guidelines. Outcome of the event was unknown.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300005067 same patient and event, different dose;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: with 5 doses of Pfizer vaccine/ tested positive for Covid after the holidays; with 5 doses of Pfizer vaccine/ tested positive for Covid after the holidays; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "Lyme" (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 "with 5 doses of Pfizer vaccine/ tested positive for Covid after the holidays".  The patient was generally heathy and active male with 5 doses of Pfizer vaccine. He had mild symptoms (cough) tested positive for Covid after the holidays, he did complete a regimen of Paxlovid.  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.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 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: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: barbiturates" (unspecified if ongoing); "Known allergies: allergy to Milk" (unspecified if ongoing). Patient had no other medical history.The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: negative tests; Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 65 years, in left leg for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: FN6208), in right arm, on 02Apr2021 as dose 2, single (Lot number: FR2734), in left arm and on 03Oct2021 as dose 3 (booster), single (Lot number: FC3S92), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). No Known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Oct2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received treatment of COVID-19 from 30Dec2022 to 04Jan2023.
Age: 47.0
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 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 47 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: "thyroidectomy" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies. 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 and included Paxlovid from 29Dec2022 to 03Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events Covid-19 and drug ineffective are related to BNT162b2, BNT162b2 omi ba.4-5 administration cannot be excluded. This case will be reassessed should additional information become available.
Age: 73.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Off label use, Polymyalgia rheumatica, Product use issue
Clinical narrative: Diagnosed with PMR; other vaccine same date product= Flu; other vaccine same date product= Flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 12:15 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 14Oct2022 as unk, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Oct2022, outcome "unknown" and all described as "other vaccine same date product= Flu"; POLYMYALGIA RHEUMATICA (medically significant) with onset 31Oct2022 at 06:15, outcome "not recovered", described as "Diagnosed with PMR". Therapeutic measures were taken as a result of polymyalgia rheumatica.  Additional information: There were no known allergies.   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: 67.0
Sex: F
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 (healthcare professional). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication included: AMLODIPINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 received anti-viral covid-19 treatment (Paxlovid) from 31Dec2022 to 05Jan2023.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE  & COVID-19 and The suspected drug cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 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 included: "acid reflux" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment medication for Covid-19 from 28Dec2022 and stopped on 02Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer/BioNTech, Date: 23Oct2021; Modern, Date: 06Feb2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 78 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FM0698), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Jan2021 as dose 1, single (Lot number: 027L20A), in right arm and on 06Feb2021 as dose 2, single (Lot number: O16M20A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "microscopic colitis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "scoliosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Oct2021, outcome "unknown", described as "Pfizer/BioNTech, Date: 23Oct2021; Modern, Date: 06Feb2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 26Dec2022 to 01Jan2023 as treatment of COVID-19. The patient had no known allergies.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid positive infection; covid positive infection; This is a spontaneous report received from a contactable reporter (Nurse). A 56-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) 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 09Jan2023, outcome "recovering" and all described as "covid positive infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid + infection; Covid + infection; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 26-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 04Feb2021 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) all with onset 08Jan2023, outcome "recovering" and all described as "Covid + infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2023) Positive, notes: Nasal swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: I was COVID positive; I was COVID positive; Moderna Dose Number 2 / Pfizer sucrose Dose Number 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 12Aug2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), in arm and on 12Aug2022 as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunization. The patient's relevant medical history included: "Bi polar" (unspecified if ongoing), notes: Other medical history: Bi polar; "Known allergies: Apples" (unspecified if ongoing), notes: Known allergies: Apples; "Known allergies: pistachios" (unspecified if ongoing), notes: Known allergies: pistachios; "diabetic", start date: 09Sep2021 (unspecified if ongoing), notes: hospitalization: 5 days; not recovered; treatment: Insulin. The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Aug2022 at 12:00, outcome "unknown", described as "Moderna Dose Number 2 / Pfizer sucrose Dose Number 3"; DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "recovered" and all described as "I was COVID positive". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 5 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Nov2022) Negative, notes: Nasal Swab. Additional information: The patient did not receive other vaccine in four weeks and no other medication in two weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
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 administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP7534), in right arm and on 12Apr2021 as dose 2, single (Lot number: ER8731) at the age of 40 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Lot number: 033F21A), in right arm and on 21Oct2022 as dose 4 (booster), single (Lot number: 061F22A), 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 10Dec2021, outcome "recovering", described as "Interchange of vaccine products administered"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (04Jan2023) Negative, notes: home test was negative; (10Jan2023) Positive, notes: positive at home test 6 days after. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Rebound symptoms and a positive at home test 6 days after an at home test was negative. Total of 7 days after completing Paxlovid. The outcome of the events was recovering.
Age: 36.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 15:00 as dose 4 (booster), single (Lot number: GT2524) at the age of 36 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive for covid; Negative, notes: Positive for covid then tested negative on mornings of day 8 and day 10 of isolation; Negative, notes: Positive for covid then tested negative on mornings of day 8 and day 10 of isolation; Positive, notes: tested positive again on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Positive for covid then tested negative on mornings of day 8 and day 10 of isolation. Started to feel symptoms (congestion, coughing, sore throat) on day 10 and tested positive again on day 11.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jul2022 at 14:15 as dose 3 (booster), single (Lot number: FJ4991) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Mar2021 at 09:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Mar2021 at 12:45 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Dec2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Jul2022 at 14:15, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2022) Positive; (01Jan2023) Positive; (06Jan2023) Negative; (07Jan2023) Negative; (09Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Got COVID on 31Dec2022 tested positive just past midnight about 00:30 AM on 01Jan2023. Treated with Paxlovid. Got better and tested negative on 06Jan2023 and 07Jan2023. On 09Jan2023 tested Positive for COVID again. Patient did not have the known allergies.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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.  An adult male patient received BNT162b2 (BNT162B2), 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, lot number unknown), for COVID-19 Immunization, reaction(s): "Sore arm"; BNT162b2 (Dose 2, single, lot number unknown), for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  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) : PFIZER INC-202300012926 same patient, events after different doses of the vaccine;
Sex: U
Vaccine: COVID19, PNC20
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre; This is a spontaneous report received from a contactable reporter(s) (Physician).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; 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: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre". Additional information: Caller (Physician) has a patient who received Prevnar 20 and also had covid-19 vaccine 5 days ago or maybe 10 days ago as he mentioned. Unfortunately the patient came down with Guillain-Barre so he was curious about the information about the rates of Guillain-Barre with covid.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein), BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently provided, Guillain-Barre syndrome more likely represents a intercurrent medical condition; Antecedent viral or bacterial infections are the commonly associated triggers.  Probing for recent medical conditions prior to the onset of GBS such as diarrhea and upper respiratory infection together with detailed lab investigations including pathogens detection are needed to identify an alternative etiology.  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: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Organ failure, Thrombosis
Clinical narrative: He had a heart attack; He died from blood clots and organ failure; He died from blood clots and organ failure; This is a spontaneous report received from a contactable reporter (Consumer), Program ID: (Unknown). A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 2, unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (dose 1, unknown manufacturer), for Covid-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "He had a heart attack"; THROMBOSIS (death, medically significant), ORGAN FAILURE (death), outcome "fatal" and all described as "He died from blood clots and organ failure". The patient date of death was unknown. Reported cause of death: "He had a heart attack", "He died from blood clots and organ failure". It was not reported if an autopsy was performed. Clinical course: The patient had had a heart attack the next morning after having his 3rd booster and died 7-10 days later after having 5 more heart attacks in a couple days following the booster. He died from blood clots and organ failure. The reporter believe the Pfizer vaccine killed his father.  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.; Reported Cause(s) of Death: He died from blood clots and organ failure; He died from blood clots and organ failure; He had a heart attack
Sex: U
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 24-year-old patient received BNT162b2 (COMIRNATY), 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: CARDIAC ARREST (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: psoriasis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2023US001532_NC.  An 80-year-old female patient 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: PSORIASIS (non-serious), outcome "unknown".  Additional information: Patient stated she started getting psoriasis after getting the covid shot.  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: COVID-19, Drug ineffective
Clinical narrative: Diagnosed with COVID-19/coughing with light phlegm, sneezing, fever, chills, and body aches; Diagnosed with COVID-19/coughing with light phlegm, sneezing, fever, chills, and body aches; 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 74-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Lot number: EN6207) and in 2021 as dose 2, single (Lot number: WE0179) for covid-19 immunisation. The patient's relevant medical history included: "fatty liver disease" (unspecified if ongoing); "Lung cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Jan2023, outcome "recovering" and all described as "Diagnosed with COVID-19/coughing with light phlegm, sneezing, fever, chills, and body aches". The events "diagnosed with covid-19/coughing with light phlegm, sneezing, fever, chills, and body aches" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient reported receiving two doses of the Pfizer COVID-19 vaccine at different dates as a primary series in the year 2021, month and day not provided. The first dose was lot EN6207 and the second dose was lot WE0179. The patient stated he did not receive any booster doses of the COVID-19 vaccine because he did not want to get them. The patient woke up Friday morning, 06Jan2023, experiencing coughing with light phlegm, sneezing, fever, chills, and body aches. The patient went to the Emergency Room on Saturday, 07Jan2023, and was diagnosed with COVID-19 and prescribed Paxlovid. The patient reported feeling a little better on Saturday after starting Paxlovid and feeling much better today. The patient asked what else he could take to treat COVID-19 if he did not have Paxlovid; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021303294 same patient, different dose/event;