chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: Unknown. The reporter is the parent. A female patient in her 30's received BNT162b2 (BNT162B2), on 10Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "hearing impaired" (unspecified if ongoing), notes: hearing impaired prior to getting the vaccine. She is in her 30's and it is congenital. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Feb2022, outcome "unknown" and all described as "she tested positive for COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Feb2022) positive. 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 available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Fatigue, Pain in extremity, Palpitations
Clinical narrative: Severe shoulder and arm pain; Severe shoulder and arm pain; Chest pain; Feeling of extreme fatigue; Heart racing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2022 at 15:30 as dose 1, single (Lot number: FK9893) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V Leiden" (unspecified if ongoing); "Thyroiditis" (unspecified if ongoing); "PCOS" (unspecified if ongoing), notes: PCOS; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 29Apr2022 at 08:00, outcome "not recovered"; FATIGUE (non-serious) with onset 29Apr2022 at 08:00, outcome "not recovered", described as "Feeling of extreme fatigue"; PALPITATIONS (non-serious) with onset 29Apr2022 at 08:00, outcome "not recovered", described as "Heart racing"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 29Apr2022 at 08:00, outcome "not recovered" and all described as "Severe shoulder and arm pain". Therapeutic measures were taken as a result of pain in extremity, arthralgia, chest pain, fatigue, palpitations.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 and not tested for COVID-19, since the vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: whole body shaking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 13:45 as dose 4 (booster), single (Lot number: FK9895) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Other medical history: Rheumatoid arthritis, atypical migraine; "atypical migraine" (unspecified if ongoing), notes: Other medical history: Rheumatoid arthritis, atypical migraine. Concomitant medication(s) included: METHOTREXATE; FOLIC ACID; NORTRIPTYLINE; UBRELVY. Past drug history included: Ampicillin for Known allergies: Ampicillin, notes: Known allergies: Ampicillin. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (dose: 3), for COVID-19 immunization. The following information was reported: TREMOR (non-serious) with onset 10Apr2022, outcome "recovered", described as "whole body shaking". Therapeutic measures were not taken as a result of tremor.  Additional information: Approximately 10 hours after the vaccination, she had whole body shaking and rigor with no fever. Episode lasted approximately 2 hours. No other vaccine in four weeks.. No COVID prior vaccination. No COVID tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown). The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing); "Dose 1 and 2: Pfizer/ dose 3: Moderna" (unspecified if ongoing), notes: Dose 1 and 2: Pfizer/ dose 3: Moderna. Concomitant medication(s) included: Duloxetine; Naltrexone. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "not recovered" and all described as "Still testing positive on day 13". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: Still testing positive on day 13. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Sep2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 30Mar2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 07Sep2009. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022 at 15:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive, notes: Positive test 1 week after finishing course of Paxlovid. Therapeutic measures were not taken as a result of vaccination failure, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Solution for injection), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE, solution for injection), 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: "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "hyperlipidemia" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing), notes: Sulfa allergy. Concomitant medication(s) included: LEVOTHYROXINE oral, start date: 01Apr2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 28Apr2022, outcome "not recovered" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive. Therapeutic measures were taken as a result of Covid-19, drug ineffective. Clinical information: She developed new cough and tested positive for COVID-19 by rapid antigen Binax test 8 days after completing Paxlovid. 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 events Covid-19, drug ineffective and the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A 66-year-old male patient 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 as dose 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS, start date: 01Sep2017. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "We got shot down for a bit due to Covid". Clinical information: patient got shot down for a bit due to Covid but lets get moving forward in helping others again! Patient getting out of hospital today but still laid up at home with drainage tubes. Patient received all vaccines including the Fourth and made sure they were all the Pfizer Vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "recovered" (Apr2022) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of Covid-19. Antiviral treatment details: start date: 26Apr2022, stop date=29Apr2022, lot number=FX2741 used for the treatment of COVID-19. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid 13Apr; Tested positive for COVID 13Apr; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 16:00 as dose 1, single (Lot number: EL8982), in left arm, on 03Mar2021 at 15:00 as dose 2, single (Lot number: EN6198), in left arm, on 06Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FE2589), in left arm and on 12Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK4989) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: Name of Drug as Reported : Latex, Reaction : allergy. Concomitant medication(s) included: SYNTHROID, start date: Dec1999; BUPROPION HCL XL, start date: Mar2019; ALENDRONATE SODIUM, start date: Sep2019; VAGIFEM, start date: Jan2015; NAC SR, start date: Mar2019; MOVE FREE ULTRA, start date: Jan2018; FLAXSEED OIL NATURE MADE, start date: Jan2017; FISH OIL, start date: Jan2017; NATURE'S BOUNTY OPTIMAL SOLUTIONS HAIR, SKIN & NAILS, start date: Jan2020. Past drug history included: Percocet, reaction(s): "Allergy", notes: known allergies: Percocet. The following information was reported: COVID-19 (medically significant) with onset 13Apr2022 at 08:00, outcome "unknown", described as "Tested positive for COVID 13Apr"; VACCINATION FAILURE (medically significant) with onset 13Apr2022 at 08:00, outcome "unknown", described as "Tested positive for Covid 13Apr". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Apr2022) Positive; (Apr2022) Negative; (29Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received treatment of Covid-19 with antiviral medication Paxlovid starting on 13Apr2022. The patient was recovered after 5 days and was tested negative. The treatment was stopped on 17Apr2022. Came down with Covid again on 23Apr2022. The patient had milder symptoms. The patient still tested positive as of 29Apr2022. The patient took other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 75-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "RECURRENT IDIOPATHIC PERICARDITIS" (unspecified if ongoing). Concomitant medication(s) included: COLCHICINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". Anti viral details: product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date: 06Apr2022, Treatment stop date: 10Apr2022, Indication: Treatment of COVID-19. Covid vaccine details: vaccine brand=Pfizer/BioNTech, Vaccine lot unknown reason=Misplaced/discarded. Adverse event: return of Covid symptoms 9 days after finishing full Paxlovid doses. Abbott rapid test done at urgent care site 17 days post finishing Paxlovid was negative. AE treatment: antibiotic (Doxycycline) and Advair inhaler. Known allergies: No. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Negative, notes: Abbott rapid test done at urgent care site 17 days post finishing Paxlovid was negative. Therapeutic measures were taken as a result of drug ineffective, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, 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 77-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "Interstitial Lung Disease(ILD)" (unspecified if ongoing). Concomitant medication(s) included: OFEV; CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]; LIPITOR; BYSTOLIC. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 30Apr2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2022) Positive. Therapeutic measures were taken as a result of sars-cov-2 test positive.  Addition information: Reported Event: After taking Paxlovid and feeling fine, a re-test today was positive and symptoms were chills and fatigue and runnning nose The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Hypersensitivity, Nasal congestion, SARS-CoV-2 test
Clinical narrative: PCR positive; PCR positive; cough; congestion; allergies last week; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 27-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL3247), on 22Feb2021 as dose 2, single (Lot number: EL3247) and on 07Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. It was unknown if patient received any other vaccine in four weeks. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Apr2022, outcome "unknown", described as "allergies last week"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022, outcome "unknown" and all described as "PCR positive"; NASAL CONGESTION (non-serious) with onset 27Apr2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 27Apr2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) Positive, notes: Covid test type post vaccination was Nasal Swab. Patient experienced allergies last week then cough and congestion on 27Apr2022 mild sx but PCR positive on 27Apr2022. It was unknown if patient had COVID-19 prior to vaccination. Patient was tested for COVID-19 post vaccination. COVID-19 test type post vaccination was Nasal Swab and COVID-19 test name post vaccination was PCR. The test was performed on 27Apr2022 with result as positive.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: PCR positive; PCR positive; cough; congestion; allergies last week; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 27-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: EL3247), on 22Feb2021 as dose 2, single (Lot number: EL3247) and on 07Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. It was unknown if patient was pregnant at the time of vaccination. It was unknown if patient received any other vaccine in four weeks. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Apr2022, outcome "unknown", described as "allergies last week"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022, outcome "unknown" and all described as "PCR positive"; NASAL CONGESTION (non-serious) with onset 27Apr2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 27Apr2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) Positive, notes: Covid test type post vaccination was Nasal Swab. Patient experienced allergies last week then cough and congestion on 27Apr2022 mild sx but PCR positive on 27Apr2022. It was unknown if patient had COVID-19 prior to vaccination. Patient was tested for COVID-19 post vaccination. COVID-19 test type post vaccination was Nasal Swab and COVID-19 test name post vaccination was PCR. The test was performed on 27Apr2022 with result as positive.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He presents a vaccine card with two vaccines but not in state registry suspect it was altered. then got sx covid 4/26 and then tested positive 4/27; He presents a vaccine card with two vaccines but not in state registry suspect it was altered. then got sx covid 4/26 and then tested positive 4/27; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 36-year-old male patient received BNT162b2 (BNT162B2), on 03Jul2021 as dose 1, single (Lot number: EW0180) at the age of 35 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Other vaccine in four weeks: Unknown. Covid prior vaccination: Unknown. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "He presents a vaccine card with two vaccines but not in state registry suspect it was altered. then got sx covid 4/26 and then tested positive 4/27". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment for adverse event: Unknown. Covid test type post vaccination: Unknown. Covid test name post vaccination: Home Ag, Covid test date: 27Apr2022, Covid test result: Positive Device timestamp: 29Apr2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the drug ineffective, covid-19 cannot be completely excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19 Treatment; 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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: en9581), in right arm, on 20Feb2021 as dose 2, single (Lot number: el9267), in left arm and on 01Sep2021 as dose 3 (booster), single (Lot number: fd8448) at the age of 67 years, in right arm 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), outcome "unknown", described as "COVID 19"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (24Apr2022) Negative; (30Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Patient had no other medication received within 2 weeks. On 19Apr2022, patient had received covid-19 treatment Paxlovid until 24Apr2022. Adverse event tested negative on 24Apr after completing 5 day dose of Paxlovid. On 30Apr2022 had sore throat, stuffy nose. Tested positive for covid.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FAMOTIDINE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "if_vaccine_received Yes/vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive once again for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID 19 Treatment which included treatment with Paxlovid (from 18ASpr2022 to 22Apr2022). Patient started Paxlovid treatment 3 days after onset of COVID symptoms. Symptoms disappeared two days after beginning Paxlovid treatment. 5 days after stopping the 5-day course of Paxlovid treatment, symptoms returned and I tested positive once again for COVID. It has been 4 days since symptoms have returned, and symptoms have significantly improved, but some minor symptoms still linger.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (primary immunization, manufacture unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had not received other medication in 2 weeks. Adverse event Rebound infection started 2 days after completing treatment. Treatment was reported as, from 01Apr2022 to 05Apr2022 as anti viral medications (unspecified).  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 information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the drug ineffective, covid-19 cannot be completely excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 20Mar2021 as dose 2, single (Lot number: EN6207), in left arm and on 26Sep2021 as dose 3 (booster), single (Lot number: FF2588) at the age of 50 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "A-fibrillation" (unspecified if ongoing). Concomitant medication(s) included: Eliquis; Metformin; Jardiance; Insulin; Cartia XT; Metoprolol; Omeprazole. Past drug history included: Lisinopril, reaction(s): "Known allergies: lisinopril"; Penicillin, reaction(s): "Known allergies: Penicillin"; Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Getting better and testing negative on home tests; Dark black test line, notes: Retested and home test was immediately dark black test line. Therapeutic measures were taken as a result of Covid-19. No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: seasonal" (unspecified if ongoing); "Known allergies: environmental" (unspecified if ongoing). There were no concomitant medications received in 2 weeks. Past drug history included: Amlodipine, reaction(s): "Known allergies: Amlodipine". Vaccination history included: Covid-19 vaccine (Primary Immunization series completed;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID (Lot: FT5400, start date: 26Apr2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Small fibre neuropathy
Clinical narrative: small fiber neuropathy; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2021 as dose 2, single (Lot number: EZ32489) at the age of 35 years for covid-19 immunisation. The patient's relevant medical history included: "Prolactinoma and infertility" (unspecified if ongoing); "infertility" (unspecified if ongoing). The patient's concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. Vaccination history included: BNT162b2 (Dose Number: 1, Manufacturer: Pfizer, Batch/Lot No: EJ1685), administration date: 19Dec2020, when the patient was 35-year-old, for COVID-19 immunization. The following information was reported: SMALL FIBRE NEUROPATHY (disability) with onset 05Feb2021, outcome "recovered with sequelae", described as "small fiber neuropathy". The event "small fiber neuropathy" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures post vaccination: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of small fibre neuropathy which included IVIG, Lyrica, gabapentin, steroids. Clinical course: Diagnosed with new small fiber neuropathy requiring 8 doses of IVIG due to the covid 19 vaccination. Recovered with lasting effects.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event small fibre neuropathy and the suspect product BNT162b2  cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2020 as dose 1, single (Lot number: 5130), on 08Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 27Aug2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies:Penicillin" (unspecified if ongoing), notes: Known allergies: Sulfa, penicillin; "Hashimotos" (unspecified if ongoing); "Familial Hemiplegic migraine" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: MUCINEX; VITAMIN D3; VITAMIN C [ASCORBIC ACID]; OREGANO OIL; MOTRIN [IBUPROFEN]; TYLENOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Apr2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) positive, notes: Confirmed positive via PCR 20Apr2022; (19Apr2022) positive, notes: Positive on rapid antigen; (27Apr2022) Negative, notes: Negative rapid antigen tests on 27Apr2022 and 28Apr2022; (28Apr2022) Negative, notes: Negative rapid antigen tests on 27Apr2022 and 28Apr2022; (30Apr2022) positive, notes: Positive rapid antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Rebound infection. Symptoms began 18Apr2022. Tested positive on rapid antigen 19Apr2022. Started Paxlovid 20Apr2022. Confirmed positive via PCR 20Apr2022. Finished Paxlovid course on 25Apr2022. Symptoms resolved 27Apr2022. Negative rapid antigen tests on 27Apr2022 and 28Apr2022. Return of symptoms 29Apr2022. Positive rapid antigen test 30Apr2022. Patient had received anti-viral treatment of Paxlovid from 20Apr202 to 25Apr2022. It was reported that patient had received Other medication in 2 weeks.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Flu like symptoms; Low fever; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2022 at 12:00 as dose 4 (booster), single (Lot number: fk9893) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Other medical history: Hypothyroidism; "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN. Concomitant medication(s) included: SYNTHROID; ESTRADIOL; PROGESTERONE; SUDAFED [GUAIFENESIN;PSEUDOEPHEDRINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: fj1620, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 19Nov2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: el3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 15Mar2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: el3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 22Feb2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 01May2022, outcome "not recovered", described as "Body aches"; INFLUENZA LIKE ILLNESS (non-serious) with onset 01May2022, outcome "not recovered", described as "Flu like symptoms"; PYREXIA (non-serious) with onset 01May2022, outcome "not recovered", described as "Low fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of influenza like illness, pyrexia, pain.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16May2021 as dose 2, single (Lot number: EW0172) at the age of 52 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: (well managed with medication); "obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE, start date: 01Aug1991; BUSPIRONE, start date: 29Sep2021; LOSARTAN, start date: 15Jun2015; HYDROCHLOROTHIAZIDE, start date: 15Jun2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Positive, notes: positive Covid test AM; (21Apr2022) Negative, notes: Day -1 negative Covid test AM; (26Apr2022) Negative, notes: Day 6 (26Apr) negative Covid test in evening (01May2022) Positive, notes: Day 11 (01May) tested positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 15-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jun2021 as dose 1, single (Lot number: EW0180), on 09Jul2021 as dose 2, single (Lot number: EW0196) and on 17Jan2022 as dose 3 (booster), single (Lot number: 33036BD) at the age of 14 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 01May2022, outcome "unknown", COVID-19 (medically significant) with onset 01May2022, outcome "recovering" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course included no other vaccines in four weeks and No other medications in two weeks. No known allergies.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: I tested positive for Covid; I tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "known allergies Cipro", notes: known allergies Cipro. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Apr2022, outcome "recovered" (30Apr2022) and all described as "I tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (13Apr2022) Positive; (21Apr2022) Negative; (22Apr2022) Positive; (30Apr2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course; COVID 19 Treatment Brand Paxlovid treatment start date was 14Apr2022 and treatment stop date was 18Apr2022, Indication of treatment of COVID-19. He had a relapse of COVID after taking Paxlovid. He was tested positive for Covid on 13Apr (on an Antigen test). He began Paxlovid on 14Apr and ended on 18Apr. Symptoms quickly subsided and by 21Apr He had a nearly negative antigen test. Then 0n 22Apr2022 He began testing more and more positive on Antigen tests and remained positive until a negative antigen test on 30Apr. He was experienced mild symptoms during both phases of the infection. Device timestamp was reported as, 30Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 19Nov2021 at 16:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "Shell fish" (unspecified if ongoing). Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE MAGNESIUM]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received other medications in 2 weeks.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 27Jan2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Nov2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Congenital hypothyroidism" (unspecified if ongoing), notes: Synthroid CH. Concomitant medication(s) included: Lexapro; Buspar; Metoprolol; Cardura; Losartan Potassium; Synthroid taken for congenital hypothyroidism. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Rebound of Covid after Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Apr2022) Positive. Therapeutic measures were taken as a result of Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: 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 30-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, which include Antiviral from 20Apr2022 to 24Apr2022. Clinical course: The symptoms included Cold symptoms, coughing, sneezing, stuffy nose, runny nose, congestion from 29Apr2022 and were reported as recovering. No treatment was received for the symptoms. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.