chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXAPRO; BUSPIRONE; WELLBUTRIN. Past drug history included: Amoxicillin, reaction(s): "Known allergy: Amoxicillin". 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: unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: COVID 19 Treatment; Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: 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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 08Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 05Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) negative, notes: a positive RAT after 5 days of negatives on day 13 (7 days post last paxlovid dose); (13Jun2022) Positive, notes: a positive RAT after 5 days of negatives on day 13 (7 days post last paxlovid dose). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: patient received Paxlovid for COVID 19 Treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 13Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, 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: VACCINATION FAILURE (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) Unknown results, notes: COVID 19 Treatment; (10Jun2022) Negative; (11Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks was reported as no. Antiviral details: product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 02Jun2022, Treatment stop date: 07Jun2022, Indication: Treatment of COVID-19, Adverse event: Paxlovid rebound. Symptoms returned 3 days after treatment ended. Rapid antigen at home test returned a negative result Friday 10Jun2022 and then changed back to positive after symptoms returned one day post symptoms on Saturday 11Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: Em9809), in left arm and on 03Mar2021 as dose 2, single (Lot number: En6205) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Nov2021 as dose 3 (booster), single (Lot number: 027h21b), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sarcoidosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The patient had no known allergies. Other medication in two weeks reported as unknown. Anti-viral details: Product: COVID 19 Treatment. Brand: Pfiser. Treatment start date: 01Jun2022. Treatment stop date: 6Jun2022. Indication: Treatment of COVID-19. Rebound COVID 19. Patient felt fine for a week, now have congestion, scratchy throat cough.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid: Treatment of COVID-19; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Additional information: There was other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: Ep7534), in right arm, on 16Apr2021 as dose 2, single (Lot number: Er8731), in right arm, on 22Oct2021 as dose 3 (booster), single (Lot number: Ff2589), in right arm and on 08Apr2022 as dose 4 (booster), single (Lot number: Fk9894) at the age of 62 years, in right 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) with onset 02Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 02Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
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) from product quality group. The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 09:00 as dose 4 (booster), single (Lot number: FL3209) at the age of 81 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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: 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: Tested positive (after negative antigen test) 7 days after stopped treatment with Paxlovid. Symptoms included runny nose, fatigue, and cough.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid 19; Covid 19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 31Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "Nickel" (unspecified if ongoing). Date of last menstrual period: 20Mar2022. The patient is expected to deliver a baby(s) on 25Dec2022. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19". Therapeutic measures were not taken as a result of drug ineffective, covid-19.. Clinical course of the events: vaccine received: Yes. Other medication in 2weeks: No. Known allergies: Nickel. Other medical history: None.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid:Treatment of COVID-19; Paxlovid: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 53-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: Fj4991) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Other medication in 2weeks: Yes. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LOSARTAN; METFORMIN; OMEPRAZOLE; ROSUVASTATIN. The following information was reported: COVID-19 (medically significant) with onset 10Jun2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "Paxlovid: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 covid-19, drug ineffective. Anti-viral details, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 02Jun2022, Treatment stop date: 08Jun2022, Indication: Treatment of COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, 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) all with onset 06Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. This report was about COVID-19 treatment. Patient did receive the vaccine. Patient received other medications in 2 weeks. Patient received treatment for COVID-19 as Paxlovid from 27May2022 to 31May2022  No follow up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received 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 on 13May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "Auto-immune disorder" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergy: Sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: No other medication in 2 weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid: Treatment of COVID-19; Paxlovid: 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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Paxlovid: Treatment of COVID-19".  Clinical course: Rebound, symptoms 10 days after medication. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Hypersensitivity, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Tested + 09Jun2022; Tested + 09Jun2022; sx of allergies ST; Runny nose; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 35-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: EP6955) and on 16Apr2021 as dose 2, single (Lot number: EP6955) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Dec2021 as dose 3 (booster), single (Lot number: 067421A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 07Jun2022, outcome "unknown"; RHINORRHOEA (non-serious) with onset 07Jun2022, outcome "unknown", described as "Runny nose"; HYPERSENSITIVITY (non-serious) with onset 07Jun2022, outcome "unknown", described as "sx of allergies ST"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jun2022, outcome "unknown" and all described as "Tested + 09Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive, notes: Covid test type post vaccination: Nasal swab tested.  Clinical course: The patient was diagnosed with of allergies ST, runny nose and fatigue starting 07Jun2022 and then tested 09Jun2022. The patient did not had covid prior vaccination and tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Tested + 09Jun2022; Tested + 09Jun2022; sx of allergies ST; Runny nose; Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 35-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: EP6955) and on 16Apr2021 as dose 2, single (Lot number: EP6955) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Dec2021 as dose 3 (booster), single (Lot number: 067421A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 07Jun2022, outcome "unknown"; RHINORRHOEA (non-serious) with onset 07Jun2022, outcome "unknown", described as "Runny nose"; HYPERSENSITIVITY (non-serious) with onset 07Jun2022, outcome "unknown", described as "sx of allergies ST"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jun2022, outcome "unknown" and all described as "Tested + 09Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive, notes: Covid test type post vaccination: Nasal swab tested.  Clinical course: The patient was diagnosed with of allergies ST, runny nose and fatigue starting 07Jun2022 and then tested 09Jun2022. The patient did not had covid prior vaccination and tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Batch/Lot number: unknown), on 12Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 21May2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN; ARMOUR THYROID. Past drug history included: Nsaids, reaction(s): "known allergies: NSAIDS"; Hydrocodone, reaction(s): "known allergies: hydrocodone". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. If vaccine received was yes, Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer Paxlovid, Treatment start date: 02Jun2022. Treatment stop date: 06Jun2022, Indication: Treatment of COVID-19. Rebound of COVID 5 days after finishing Paxlovid. Adverse events start date: 11Jun2022, if patient recovered was recovering, If treatment ae was no.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
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 non-contactable reporter(s) (Other HCP).  A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization; 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 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was unknown if patient had other medication in 2 weeks. Patient had received anti-viral as a treatment for COVID-19; started on 01Jun2022 and treatment stopped on 05Jun2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Age: 66.0
Sex: M
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 contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 12Mar2021 as dose 2, single (Lot number: EN6209), in left arm and on 18Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "triglycerides" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased. 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid 300-100mg (Lot number: 00069-1085-30) from 04Jun2022 to 09Jun2022.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Test positive for COVID; Test positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL3247), in right arm and on 04Nov2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 37 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, start date: 04Nov2021, stop date: 04Nov2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jun2022, outcome "recovering" and all described as "Test positive for COVID". The event "test positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive, notes: Nasal Swab; (08Jun2022) Positive, notes: Nasal Swab; (09Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Information: The patient took other medications in two weeks birth control pills and multi vitamin.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Positive test; Positive test; This is a literature report for the following literature source(s).  A 67-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 4 (booster), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive test".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the event and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202200740728 Same article, other patient;US-PFIZER INC-202200833096 Same article, same patient, other product;US-PFIZER INC-202200833097 Same article, other patient;US-PFIZER INC-202200833098 Same article, other patient;
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Hyperthyroidism, Joint swelling
Clinical narrative: developed symptoms of what appears to be hyperthyroidism that started within a week of her getting the second COVID-19 vaccine booster; her ankles were swelling up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "injury to ankle " (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for covid-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for covid-19 immunisation; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for covid-19 immunisation. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "developed symptoms of what appears to be hyperthyroidism that started within a week of her getting the second COVID-19 vaccine booster"; SWELLING (non-serious), outcome "unknown", described as "her ankles were swelling up". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: 0.01, notes: less than 0.01. Therapeutic measures were not taken as a result of hyperthyroidism, swelling. Additional information: The patient actually called a few weeks ago and told me that her ankles were swelling up and she had previous injury to her ankle (Intent: History), that would probably have been maybe last week of April and we thought it was just something going on with her ankle but was really thought and figured it out and the connection with her having had the vaccine yesterday during conversation with her. No, it was sort of partially diagnosed at this point in time and her doctor was on vacation and they have not started any treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive covid antigen test.; Positive covid antigen test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old male patient received BNT162b2 (COMIRNATY), on 02Mar2021 as dose 1, single (Lot number: EL3247), on 24Mar2021 as dose 2, single (Lot number: EL3247) and on 22Nov2021 as dose 3 (booster), single (Lot number: EW0196) at the age of 41 years 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), COVID-19 (medically significant) all with onset 13Jun2022 at 11:00, outcome "not recovered" and all described as "Positive covid antigen test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive, notes: Covid test type post vaccination= Nasal Swab,. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Electrocardiogram, Palpitations, Swelling
Clinical narrative: Heart is beating pretty fast; It feels like her chest is like swollen like it is harder; Still feel like it's a lot of weight just being pushed on her chest; It feels like her chest is like swollen like it is harder; Still feel like it's a lot of weight just being pushed on her chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 04Jun2022 at 11:00 as dose number unknown, single (Lot number: FM0173) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset Jun2022, outcome "unknown", described as "Heart is beating pretty fast"; CHEST DISCOMFORT (non-serious), SWELLING (non-serious) all with onset Jun2022, outcome "unknown" and all described as "It feels like her chest is like swollen like it is harder; Still feel like it's a lot of weight just being pushed on her chest". The events "heart is beating pretty fast" and "it feels like her chest is like swollen like it is harder; still feel like it's a lot of weight just being pushed on her chest" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient called to Pfizer because she was having side effects from the shot (Pfizer COVID-19 vaccine). The patient just feel like her heart was beating pretty fast and it felt like her chest was like swollen like it was harder, felt like 'if she pressed it just feel push on the chest'. Yes so she went to the doctor yesterday (09Jun2022) and she got a EKG and everything and they said everything was fine but she still felt like it's a lot of weight just being pushed on her chest.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 09Jun2022 tested + after a neg runny nose and fatigue, dizzy; 09Jun2022 tested + after a neg runny nose and fatigue, dizzy; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2021 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 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: "Low WBC" (unspecified if ongoing), notes: idiopathic. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jun2022, outcome "unknown" and all described as "09Jun2022 tested + after a neg runny nose and fatigue, dizzy". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (unspecified date) Negative; (09Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 namely Paxlovid from 01Jun2022 to 05Jun2022 (lot number: FX2741)  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events headache and the suspect product BNT162B2 cannot be ruled out.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid after receiving the vaccine; Covid after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Mar2021 as dose 2, single (Lot number: EN6202), in left arm and on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid after receiving the vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Post the vaccination, the patient has been tested for COVID-19. COVID after receiving the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835354 similar report from same reporter;
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Covid after receiving the vaccine; Covid after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Mar2021 as dose 2, single (Lot number: EN6202), in left arm and on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid after receiving the vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Post the vaccination, the patient has been tested for COVID-19. COVID after receiving the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835354 similar report from same reporter;
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Malaise
Clinical narrative: joint pain; Chills; Fever; Tiredness; horrible nightmare when I fall asleep; I really feel awful; felling terrible; 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 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), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; NIGHTMARE (non-serious), outcome "unknown", described as "horrible nightmare when I fall asleep"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I really feel awful"; MALAISE (non-serious), outcome "unknown", described as "felling terrible".  Additional Information: Consumer stated, I just have a question. I don't need to be reporting, I just have a question about booster that I got. I received the Pfizer Booster (Name not clarified, hence captured as Unspecified booster) yesterday around 11 and I was fine and then I got the horrible joint pain that I got with the first two shots (Further clarification unknown, hence suspect captured conservatively as unspecified shots; Manufacture not clarified, hence tab left unchecked) now I have like joint pain and chills and may be a fever but I don't know but you know tiredness and having horrible nightmare when I fall asleep. So, my question is how long is this last because its not severe enough to go hospital but I really feel awful. By then hopefully the side effect will go away by Monday, wouldn't you think. They don't last forever when you get the shot. They should have somebody there all weekend because they want you to call and you are felling terrible you cant go the the hospital. So, they want people to get the vaccine, they should tell us if you getting this shot on weekend we are close. I am not blaming you but its ridiculous they want these people to get these vaccine, oh I am am sorry we cant talk to you now because we are not working that's just awful. You also give me the number I will wait till Monday .LOT#: Consumer stated, I don't know it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835540 Same patient, same product, different dose.
Sex: U
Vaccine: COVID19
Symptoms: Nightmare, Pyrexia
Clinical narrative: joint pain; Chills; Fever; Tiredness; horrible nightmare when I fall asleep; I really feel awful; felling terrible; 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 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), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; NIGHTMARE (non-serious), outcome "unknown", described as "horrible nightmare when I fall asleep"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I really feel awful"; MALAISE (non-serious), outcome "unknown", described as "felling terrible".  Additional Information: Consumer stated, I just have a question. I don't need to be reporting, I just have a question about booster that I got. I received the Pfizer Booster (Name not clarified, hence captured as Unspecified booster) yesterday around 11 and I was fine and then I got the horrible joint pain that I got with the first two shots (Further clarification unknown, hence suspect captured conservatively as unspecified shots; Manufacture not clarified, hence tab left unchecked) now I have like joint pain and chills and may be a fever but I don't know but you know tiredness and having horrible nightmare when I fall asleep. So, my question is how long is this last because its not severe enough to go hospital but I really feel awful. By then hopefully the side effect will go away by Monday, wouldn't you think. They don't last forever when you get the shot. They should have somebody there all weekend because they want you to call and you are felling terrible you cant go the the hospital. So, they want people to get the vaccine, they should tell us if you getting this shot on weekend we are close. I am not blaming you but its ridiculous they want these people to get these vaccine, oh I am am sorry we cant talk to you now because we are not working that's just awful. You also give me the number I will wait till Monday .LOT#: Consumer stated, I don't know it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835540 Same patient, same product, different dose.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: got the horrible joint pain that I got with the first two shots; 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: ARTHRALGIA (non-serious), outcome "unknown", described as "got the horrible joint pain that I got with the first two shots".  Additional information: Consumer stated, "I just have a question. I don't need to be reporting, I just have a question about booster that I got. I received the Pfizer Booster (Name not clarified, hence captured as Unspecified booster) yesterday around 11 and I was fine and then I got the horrible joint pain that I got with the first two shots (Further clarification unknown, hence suspect captured conservatively as unspecified shots; Manufacture not clarified, hence tab left unchecked) now I have like joint pain and chills and may be a fever but I don't know but you know tiredness and having horrible nightmare when I fall asleep. So, my question is how long is this last because its not severe enough to go hospital but I really feel awful." Consumer was informed about Pfizer drug safety role. Consumer was informed medical information department.Consumer stated, "By then hopefully the side effect will go away by Monday, wouldn't you think. They don't last forever when you get the shot. They should have somebody there all weekend because they want you to call and you are felling terrible you cant go the the hospital. So, they want people to get the vaccine, they should tell us if you getting this shot on weekend we are close. I am not blaming you but its ridiculous they want these people to get these vaccine, oh I am am sorry we cant talk to you now because we are not working that's just awful. You also give me the number I will wait till Monday." Consumer stated, "No, I am not doing that because its the same side effect that's they have on the list. It's not anything different, my question is how long do I have that its not anything new so no point documenting anything, if am feeling something unusual but its not its stuff they do know."  QR Comment: Reporter type could not be probed, hence captured as consumer or other non-health professional.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200835533 Same patient, same product, different dose.