chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number 4: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 09:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 at 11:00 as dose 1, single (Lot number: EN6201), in left arm, on 24Mar2021 at 11:00 as dose 2, single (Lot number: ER8732), in left arm and on 05Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: latex(mild)" (unspecified if ongoing); "AV block w/pacemaker" (unspecified if ongoing); "MGUS" (unspecified if ongoing); "environmental allergies mild" (unspecified if ongoing); "AV block w/pacemaker" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 01May2022; B-COMPLEX [VITAMIN B NOS], start date: 01Dec2021; OSTEO NUTRIENTS II (WITH VITAMIN K2-7), start date: 01Dec2022; FEXOFENADINE HYDROCHLORIDE, start date: 01Dec2020; MAGNESIUM CITRATE, start date: 01Oct2020. Past drug history included: Wellbutrin, reaction(s): "known allergies: Wellbutrin".  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Apr2022, outcome "unknown", described as "Dose Number 4: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive, notes: On Day #10 woke with sore throat, cough, and hoarseness, runny nose and had positive antigen test.  (COVID rebound); (Jan2023) Negative, notes: Tested negative day 6 and 9; (Jan2023) Negative, notes: Tested negative day 6 and 9. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Anti-viral Product Brand Paxlovid for COVID 19 Treatment started on 09Jan2023 and stopped on date 13Jan2023. The patient experienced Metallic mouth, intermittent nausea while taking Paxlovid side effects stopped on day #6 after finishing Paxlovid. All COVID symptoms ceased. Tested negative day 6 and 9. On Day 10 woke with sore throat, cough, and hoarseness, runny nose and had positive antigen test. (COVID rebound).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2 NOS), on 13Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years 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 Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Plaxovid from 11Jan2023 to 16Jan2023 for the treatment of COVID-19. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Dose Number 5; Moderna; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jun2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 53 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6195), on 09Apr2021 as dose 2, single (Lot number: 0153) and on 30Nov2021 as dose 3 (booster), single (Lot number: FF2593) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Oct2022 at 08:15 as dose 5 (booster) single (Lot number: 053D224), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Oct2022, outcome "unknown", described as "Dose Number 5; Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other medication was taken in 2 weeks. Patient received Paxlovid Treatment from Jan2023 till Jan2023. Patient did not had Known allergies and no medical history was reported.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at the injection site; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 at 10:00 as dose 2, single (Lot number: EN9581, Expiration Date: May2021) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "kidney removed", start date: Oct2021 (unspecified if ongoing); "Sciatica" (unspecified if ongoing), notes: Had sciatica so bad, had to lay in bed; "Back surgery" (unspecified if ongoing), notes: had back surgery in the past; "mass in kidney and looked very cancerous" (unspecified if ongoing), notes: looked very cancerous; "Nerve block" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Oxycodone (as reported) for pain, reaction(s): "did not take the pain away", notes: Strength: 5mg, Count: Not provided, Additional lot numbers: Unknown. Vaccination history included: BNT162b2 (DOSE 1, SINGLE;  Manufacturer: Pfizer; NDC: Unknown; LOT: EL3249; Expiration Date: May2021, Dose and Route: injected into right arm; dose amount unknown, Time: around 18:00-19:00; drive-thru vaccine facility), administration date: 18Jan2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "sore arm at the injection site"; Shingles ("Caller and his wife had all vaccines, from shingles to whatever"). The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Sore at the injection site". ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300032197 same patient/drug/event, different dose;US-PFIZER INC-202300032250 same patient/drug/event, different dose;US-PFIZER INC-202300032251 same patient/drug/event, different dose;US-PFIZER INC-202300030735 same patient/drug/event, different dose;
Age: 43.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: Gh9694) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies:Ivp dye" (unspecified if ongoing). Concomitant medication(s) included: PULMICORT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive; (17Jan2023) Negative, notes: Rebound COVID case 4 days after testing negative after COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid started from 11Jan2023 to 16Jan2023.   Clinical course: Rebound COVID case 4 days after testing negative after COVID. Other medication in 2 weeks product: Pulmicort (Budesonide) - Brand: AstraZeneca.  No follow-up attempts are possible. No further information is expected.
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) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 5 (booster), single (Lot number: GH9703) 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: "PMLS" (unspecified if ongoing); "Hashimoto's Thyroiditis" (unspecified if ongoing); "Periodic Limb Movement in Sleep" (unspecified if ongoing). Concomitant medication(s) included: ROPINIROLE taken for periodic limb movement disorder. Past drug history included: Amoxycillin, reaction(s): "Known allergies: Amoxycillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Jan2023 to 16Jan2023.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose Number 1 and Dose Number 2: Moderna; This is a spontaneous report received from contactable reporter(s) (Other HCP). 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 25Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 48 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: 30155BA) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Dec2020 as dose 1, single (Lot number: 025J20A) and on 25Jan2021 as dose 2, single (Lot number: 030L20A) for covid-19 immunisation. The patient's relevant medical history included: "Tachycardia" (unspecified if ongoing); "pac/pvc" (unspecified if ongoing); "pac/pvc" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). There were no concomitant medications within 2 weeks. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Oct2021, outcome "unknown", described as "Dose Number 1 and Dose Number 2: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Jan2023 to 11Jan2023.; Sender's Comments: As per the available information the causality of the events interchange of vaccine products, drug ineffective, covid-19 with the suspect can not be ruled out completely.
Sex: F
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). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 18May2021 as dose number unknown, 0.3 ml single (Lot number: EW0187) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 0.3mL, Lot: ER8736, NDC/Expiry: Unknown, this is not on the vaccine record card.), administration date: 21Apr2021, for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: The Pfizer COVID Vaccine she was administered on 18May2021 she reported sore arm which lasted for almost 2 months or a little longer before she recovered completely.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test Positive; Covid test Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 8-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 1 (orange cap), single (Lot number: KF6127), in left arm, on 28Dec2021 as dose 2 (orange cap), single (Lot number: FK6127), in left arm and on 18Jul2022 as dose 3 (orange cap; booster), single (Lot number: FL8094) at the age of 8 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jan2023, outcome "unknown" and all described as "Covid test Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jan2023) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19-2, FLUC4
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 35 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 at 11:00 as dose 1, single (Lot number: EN6203), in left arm, on 26Mar2021 at 11:00 as dose 2, single (Lot number: EN6207), in left arm and on 30Sep2022 at 18:30 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Birth control" (unspecified if ongoing), notes: Other medication in 2weeks product=Birth control,. Concomitant medication(s) included: MICROGESTIN taken for contraception, start date: 01Jan2020, stop date: 22Jan2023.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative; Positive, notes: Multiple rapid tests came back positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300033748 Same reporter/patient, same drug/different dose, different AE;
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19-2, FLUC4
Symptoms: Asthenia, Asthma, COVID-19, Condition aggravated, Deafness unilateral
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 35 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 at 11:00 as dose 1, single (Lot number: EN6203), in left arm, on 26Mar2021 at 11:00 as dose 2, single (Lot number: EN6207), in left arm and on 30Sep2022 at 18:30 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Birth control" (unspecified if ongoing), notes: Other medication in 2weeks product=Birth control,. Concomitant medication(s) included: MICROGESTIN taken for contraception, start date: 01Jan2020, stop date: 22Jan2023.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative; Positive, notes: Multiple rapid tests came back positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300033748 Same reporter/patient, same drug/different dose, different AE;
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19-2, FLUC4
Symptoms: Dyspnoea, Gait disturbance, Headache, Hypopnoea, Lethargy
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 35 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 at 11:00 as dose 1, single (Lot number: EN6203), in left arm, on 26Mar2021 at 11:00 as dose 2, single (Lot number: EN6207), in left arm and on 30Sep2022 at 18:30 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Birth control" (unspecified if ongoing), notes: Other medication in 2weeks product=Birth control,. Concomitant medication(s) included: MICROGESTIN taken for contraception, start date: 01Jan2020, stop date: 22Jan2023.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative; Positive, notes: Multiple rapid tests came back positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300033748 Same reporter/patient, same drug/different dose, different AE;
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19-2, FLUC4
Symptoms: Malaise, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 09:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 35 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 at 11:00 as dose 1, single (Lot number: EN6203), in left arm, on 26Mar2021 at 11:00 as dose 2, single (Lot number: EN6207), in left arm and on 30Sep2022 at 18:30 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Birth control" (unspecified if ongoing), notes: Other medication in 2weeks product=Birth control,. Concomitant medication(s) included: MICROGESTIN taken for contraception, start date: 01Jan2020, stop date: 22Jan2023.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative; Positive, notes: Multiple rapid tests came back positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300033748 Same reporter/patient, same drug/different dose, different AE;
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: Covid AG + 20Jan2023; Covid AG + 20Jan2023; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 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 and concomitant medications were not reported. Vaccination history included: Seqirus -flucelvax quad flu vaccine.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jan2023, outcome "recovering" and all described as "Covid AG + 20Jan2023". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (20Jan2023) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other vaccine in four weeks.  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 available information in the case, an association between the reported events DRUG INEFFECTIVE & COVID-19 and The suspected drug cannot be ruled out.
Age: 59.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 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: "High cholesterol" (unspecified if ongoing), notes: other medical history: High cholesterol; "Known allergies: Sulpha" (unspecified if ongoing), notes: Known allergies: Sulpha. Concomitant medication(s) included: ATENOLOL, start date: 01Jan2010; ATORVASTATIN, start date: 01Jan2010, stop date: 19Jan2023. 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.  Clinical Course: Antiviral COVID 19 treatment Paxlovid start from on 21Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Coronary artery disease, Pulmonary embolism, Pyrexia, Thrombosis
Clinical narrative: clots in her legs, heart, and lungs; clots in her lungs; high fever; triple bypass; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Lot number: 8303000) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Lot number: EL3247), administration date: 21Jan2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "Thrombosis"; BNT162b2 (Dose: 02, Lot number: EL9269), administration date: 10Feb2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "Clots in her legs, heart and lungs", "Clots in her lungs", "high fever", "triple bypass". The following information was reported: CORONARY ARTERY DISEASE (medically significant) with onset Aug2022, outcome "unknown", described as "triple bypass"; THROMBOSIS (medically significant) with onset Oct2022, outcome "unknown", described as "clots in her legs, heart, and lungs"; PULMONARY EMBOLISM (medically significant) with onset Oct2022, outcome "unknown", described as "clots in her lungs"; PYREXIA (non-serious) with onset Oct2022, outcome "unknown", described as "high fever". The events "clots in her legs, heart, and lungs", "clots in her lungs", "triple bypass" and "high fever" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (Oct2022) Unknown results. Therapeutic measures were taken as a result of thrombosis, pulmonary embolism, coronary artery disease, pyrexia. Clinical course: Third dose given on 14Dec2021; lot: 8303000 or 830300D. Last one given on 05Dec2022; lot: PGJ3275 (latest booster). It was 6 weeks after her triple bypass that she got a fever and ended up in the Emergency room when they did blood work. That would have been early Oct2022. When asked outcome, reporter stated that she is on all kind of medications now because of this. She is on blood thinners. She went to her Cardiologist.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300033969 same reporter, patient and event, different dose;US-PFIZER INC-202300034247 same reporter, patient and event, different dose;
Age: 60.0
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 contactable reporter (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 21Dec2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 60 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Erosive lichen planus" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Migraines" (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 "not recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (20Jan2023) Negative; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid 12Jan2023 to 16Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: tremor on her left hand; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. 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: TREMOR (non-serious) with onset 2022, outcome "unknown", described as "tremor on her left hand". Additional information: Caller mentioned she has had a tremor in her left hand for over the last year (although it was not specified if it was due to the Pfizer-BioNTech COVID-19 Vaccine) and would like to know if after getting the shot there has been reports of unilateral or bilateral tremors in the upper extremities. She mentioned that this information would help her a lot to make a decision if the tremor might be a possible side effect for the COVID vaccine. She has been hearing in the news about tremors after getting the shot, but she doesn't know if this is scientifically true. She also said that she got booster and two regular shot and since it developed the tremor on her left hand. She is concerned about the tremor with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Headache, Motion sickness, Nasopharyngitis, Product use issue
Clinical narrative: eceiving the 4th shot along with flu shot/receiving Pfizer with a Flu Shot at the same time; I began to feel like having cold; car sick; I'm still having a mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Jan2023 as dose 4 (booster), single (Lot number: GH9697), in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 19Jan2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Known allergies: Penicillin (no memory, was told this)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Unknown Manufacturer), administration date: 2021, for COVID-19 Immunization; Covid-19 vaccine (Dose 2, single, Unknown Manufacturer), administration date: 2021, for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (booster), Unknown Manufacturer), administration date: Nov2022, for COVID-19 Immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Jan2023, outcome "recovering", described as "I began to feel like having cold"; HEADACHE (non-serious) with onset Jan2023, outcome "recovering", described as "I'm still having a mild headache"; MOTION SICKNESS (non-serious) with onset Jan2023, outcome "recovering", described as "car sick"; PRODUCT USE ISSUE (non-serious) with onset 19Jan2023, outcome "unknown", described as "eceiving the 4th shot along with flu shot/receiving Pfizer with a Flu Shot at the same time".  Additional information: Previous shots (2 in Mid-2021, 3rd on Nov2022) gave the patient little to no side effects after receiving, little to no impact of his daily activities. However, this time after receiving the 4th shot along with flu shot, the patient began to feel like having cold and was car sick. At the time of the report, it is the 3rd day after injection and he is still having a mild headache. Since all previous 3 shots barely affected me, the patient was unsure if this change is due to the updated Pfizer vaccine, or due to receiving Pfizer with a flu Shot at the same time.
Sex: M
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: long COVID syndrome; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long COVID syndrome".  Additional information: The caller wanted to know any information for "more than 40 years old age group" having myocarditis and pericarditis after receiving the bivalent vaccine. Th caller was asking if there is any risk of developing long COVID after receiving the bivalent vaccine and if there is any data on incidence of developing actual COVID after receiving the primary and booster dose for the same age group. Stated that he has one patient who developed long COVID syndrome after getting the bivalent dose of Pfizer COVID vaccine but that was a younger person.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; 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 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ5342), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27May2022 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 25Feb2021 as dose 2, single (Lot number: EN6203), in left arm and on 29Sep2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing), notes: (treated); "known allergies: Sulfa drugs" (unspecified if ongoing); "known allergies: Peanuts" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Dec2008. The following information was reported: COVID-19 (medically significant) with onset Jan2023, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Jan2023, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: 3 members of my family who had heart problems after taking the vaccines; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization serious complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "3 members of my family who had heart problems after taking the vaccines".  Additional information: The reporter mentioned that these vaccines are dangerous according to the news and it can be seen that all the healthy people are dying from heart failure. The reporter had 3 members of the family who had heart problems after taking the vaccines.  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-PV202300014688 same reporter/vaccine/event, different patient;US-PFIZER INC-202300034771 same reporter/vaccine/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Single), for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: All of the patient's shots including the 3 boosters were Pfizer. The patient had absolutely no complicatins and had only sore arm after each shot. That made the patient want to always use the same company going forward.   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-PV202300015071 same patient/event, different vaccine dose;US-PFIZER INC-202300035214 same patient/event, different vaccine dose;US-PFIZER INC-202300035213 same patient/event, different vaccine dose;US-PFIZER INC-202300035215 same patient/event, different vaccine dose;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization, reaction(s): "sore arm"; Bnt162b2 (2nd dose), for Covid-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Patient stated "all of my shots including the 3 boosters I have had were all Pfizer. I had absolutely no complications and only a sore arm after each shot. That made me want to always use the same  company going forward".  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-PV202300015071 same patient/event, different vaccine dose;US-PFIZER INC-202300035214 same patient/event, different vaccine dose;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  An elderly female patient 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: It was reported that all of the patient's shots including the 3 boosters were all Pfizer. The patient had absolutely no complications and only a sore arm after each shot. That made the patient want to always use the same pharma company going forward.  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-PV202300015071 same patient/event, different vaccine dose;US-PFIZER INC-202300035212 same patient/event, different vaccine dose;US-PFIZER INC-202300035213 same patient/event, different vaccine dose;US-PFIZER INC-202300035215 same patient/event, different vaccine dose;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Currently - long COVID/ Covid test result=Positive; Currently - long COVID/ Covid test result=Positive; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: IN6206), in left arm, on 18Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 44 years, in left arm for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications including Multivitamin. The following information was reported: VACCINATION FAILURE (medically significant), POST-ACUTE COVID-19 SYNDROME (medically significant) all with onset Jan2022, outcome "not recovered" and all described as "Currently - long COVID/ Covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jan2022) Positive. Clinical course: There were no other vaccines in four weeks and she did not have COVID prior to vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300029003 same patient and drug, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; This case has been considered invalid as Unidentifiable reporter and Reporter with No First-hand knowledge. Upon follow up on 23Jan2023, this case has been considered as valid all required information as new reporter added.  This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), 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 (death, hospitalization, medically significant), outcome "fatal". Therapeutic measures were taken as a result of cardiac arrest. The patient date of death was unknown. Reported cause of death: "cardiac arrest". It was not reported if an autopsy was performed.  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 available information in the case, an association between the reported events Cardiac Arrest and The suspected drug cannot be ruled out.  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.; Reported Cause(s) of Death: cardiac arrest
Sex: U
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Malaise, Nausea, Pyrexia
Clinical narrative: Severe headache; Nausea; Axillary Adenopathy; Fever; Malaise; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Severe headache"; NAUSEA (non-serious), outcome "unknown"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Axillary Adenopathy"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; MALAISE (non-serious), outcome "unknown".  Additional Information: It was reported that within 14 hours after administration of Pfizer COVID-19 vaccine, bivalent (and all previous Pfizer COVID-19-19 vaccines [Comirnaty]). Multiple, serial vaccine associated A.Es. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID in Jan2022; COVID in Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID in Jan2022". Clinical course: Got COVID after receiving Pfizer Vx. Mild case of COVID in Jan2022. Symptoms: Fatigue. Believed getting vaccinated prevented her from getting much sicker.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Pruritus, Rash macular
Clinical narrative: small red dots from the neck down; itchier in the sun; itchier in the sun; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2023NVX-US-000000009.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 02Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), PHOTOSENSITIVITY REACTION (non-serious) all with onset 04Sep2021, outcome "unknown" and all described as "itchier in the sun"; RASH MACULAR (non-serious) with onset 04Sep2021, outcome "unknown", described as "small red dots from the neck down".  Additional information: On 03Jan2023, it was reported that a patient started treatment on 02Sep2021 with Pfizer BioNTech COVID-19 vaccine Dose 1. It was reported that on 04Sep2021, 2 days after the vaccine, the patient got small red dots from the neck down, and it was itchier in the sun. The individual did not get the second dose. The patient's primary care provider reported the adverse events to the database.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.