chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: FK9231), on 22Jan2021 as dose 2, single (Lot number: LL3249) and on 01Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NYQUIL. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Nasal swab. Therapeutic measures were taken as a result of covid-19. Clinical Course: Product Information: Paxlovid on 18Apr2022 to 22Apr2022; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: I started to get dizzy. The next morning when I woke up I was extremely dizzy; I start vomiting and nausea from the dizziness; I start vomiting and nausea from the dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Prediabetic" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for glucose tolerance impaired. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization; Bnt162b2 (Dose 2, Single), for COVID-19 immunization; Bnt162b2 (Dose 3 (Booster), Single), for COVID-19 immunization, reaction(s): "I guess is 03Mar I started to get dizzy". The following information was reported: DIZZINESS (non-serious), outcome "not recovered", described as "I started to get dizzy. The next morning when I woke up I was extremely dizzy"; VOMITING (non-serious), NAUSEA (non-serious), outcome "unknown" and all described as "I start vomiting and nausea from the dizziness". The events "i started to get dizzy. the next morning when i woke up i was extremely dizzy" and "i start vomiting and nausea from the dizziness" required physician office visit. Therapeutic measures were taken as a result of dizziness, vomiting, nausea.  Additional information: The report was not related to a study or programme. The patient had other conditions. There were no investigations conducted. Consumer stated that she had her second booster shot which was a Pfizer shot. All her shots the first two in the beginning and then the booster and the second booster were all Pfizer shots, and she had her second booster on 29Apr which was the Friday. Sunday night which she guessed was 03Mar she started to get dizzy. The next morning when she woke up she was extremely dizzy then started vomiting and nausea from the dizziness. She had her 'PCP' who sent her to PT, physical therapy and till this day they were still working on her and she still don't have all of the dizziness gone and she reported this to the people who gave her the shot. Starting date of adverse event: Consumer stated, "01May, the evening of 01May. It got really bad when I woke up the next day on 02May." Treatment in response to adverse event (dizziness and vomiting): Consumer stated, "I went to a physical therapy." Consumer stated, "Help me get rid of the dizziness. It's slowly going away but I still have it. The physical therapist have been trying to help that to get this go away but for some reason it won't go anywhere."
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes for two weeks after COVID booster.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes for two weeks after COVID booster.".  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: Suspected COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EN6202), on 14Apr2021 as dose 2, single (Lot number: EN0169) and on 08Dec2021 as dose 3 (booster) single (Lot number: 33030BD) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  clinical course: Other medication in 2weeks: Yes, Known allergies: No.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; 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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: FP7534), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER8737), in left arm, on 23Aug2021 as dose 3 (booster), single (Lot number: FW0177), in left arm and on 06Feb2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease (on immunosuppressant Stelara)" (unspecified if ongoing). Concomitant medication(s) included: PENTASA, start date: Feb2018; GABAPENTIN, start date: Apr2022; ALBUTEROL SULFATE HFA, start date: Apr2022, stop date: 20May2022; WIXELA INHUB, start date: Mar2022, stop date: 20May2022; FLUOXETINE, start date: Sep2021; STELARA, start date: Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive, notes: Positive tests on 04May2022 and then again on 16May2022; (10May2022) Negative, notes: negative tests in between on 10May2022 and 11May2022; (11May2022) Negative, notes: negative tests in between on 10May2022 and 11May2022; (16May2022) Positive, notes: Positive tests on 04May2022 and then again on 16May2022; (18May2022) Positive, notes: I also tested positive on a PCR on 18May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergy. Rebound Covid - Positive tests on 04May and then again on 16May, with negative tests in between on 10May and 11May. I tested positive (antigen) for Covid the first time on 04May2022, got a prescription for Paxlovid that day, and took the full dose on schedule. I tested negative (antigen) on both 10May2022 and 11May2022 and had limited remaining symptoms. I woke up with a bad runny nose and cough again on 16May2022 and tested positive again immediately on two different antigen tests. I also tested positive on a PCR on 18May2022. I was initially told by my PCP not to do another round of Paxlovid, but when my cough got worse and into my chest, I was prescribed a second round of Paxlovid beginning 20May2022. Additionally, my son developed Covid symptoms on 17May2022 and tested positive (PCR) on 18May2022. I assume he caught it from my rebound covid, but he could have caught it elsewhere.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; 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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: FP7534), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER8737), in left arm, on 23Aug2021 as dose 3 (booster), single (Lot number: FW0177), in left arm and on 06Feb2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease (on immunosuppressant Stelara)" (unspecified if ongoing). Concomitant medication(s) included: PENTASA, start date: Feb2018; GABAPENTIN, start date: Apr2022; ALBUTEROL SULFATE HFA, start date: Apr2022, stop date: 20May2022; WIXELA INHUB, start date: Mar2022, stop date: 20May2022; FLUOXETINE, start date: Sep2021; STELARA, start date: Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive, notes: Positive tests on 04May2022 and then again on 16May2022; (10May2022) Negative, notes: negative tests in between on 10May2022 and 11May2022; (11May2022) Negative, notes: negative tests in between on 10May2022 and 11May2022; (16May2022) Positive, notes: Positive tests on 04May2022 and then again on 16May2022; (18May2022) Positive, notes: I also tested positive on a PCR on 18May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergy. Rebound Covid - Positive tests on 04May and then again on 16May, with negative tests in between on 10May and 11May. I tested positive (antigen) for Covid the first time on 04May2022, got a prescription for Paxlovid that day, and took the full dose on schedule. I tested negative (antigen) on both 10May2022 and 11May2022 and had limited remaining symptoms. I woke up with a bad runny nose and cough again on 16May2022 and tested positive again immediately on two different antigen tests. I also tested positive on a PCR on 18May2022. I was initially told by my PCP not to do another round of Paxlovid, but when my cough got worse and into my chest, I was prescribed a second round of Paxlovid beginning 20May2022. Additionally, my son developed Covid symptoms on 17May2022 and tested positive (PCR) on 18May2022. I assume he caught it from my rebound covid, but he could have caught it elsewhere.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Off label use, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Off label use; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL9262), in right arm, on 13Feb2021 as dose 2, single (Lot number: EN6201), in right arm, on 31Aug2021 as dose 3 (booster), single (Lot number: Fc3184), in right arm and on 09Feb2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholestrol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN; ZETIA; FINASTERIDE; LISINOPRIL; POTASSIUM CITRATE. The following information was reported: IMMUNISATION (medically significant) with onset 09Feb2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 09Feb2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  Clinical course: Adverse event: Frequent sneezing, slight body ache start was 20May2022 and patient recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19, Weight
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 95-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "low weight" (unspecified if ongoing), notes: Patient is low weight (88 lbs); "slow metabolizer" (unspecified if ongoing), notes: history of being a slow metabolizer (needs lower doses of medicines). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Weight: Low; 88. Therapeutic measures were taken as a result of suspected covid-19. Clinical course included: The patient received Paxlovid oral for the treatment of COVID-19 from 17May2022 to 19May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), on 15Apr2021 as dose 2, single (Lot number: ER8731) and on 15Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE, start date: 01Sep2021, stop date: 22May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body mass index, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 13:15 as dose 4 (booster), single (Lot number: FK9893) at the age of 70 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: "BMI 39.9" (unspecified if ongoing); "3 time cancer survivor" (unspecified if ongoing), notes: Other medical history: 3 time cancer survivor, 70+ yrs old; "Only topical allergy to latex" (unspecified if ongoing), notes: Known allergies: Only topical allergy to latex. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body mass index: (unspecified date) 39.9; SARS-CoV-2 test: (unspecified date) positive; (15May2022) positive, notes: I tested positive 2 days after completing 10 dose course of treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took no other medication in 2weeks. COVID 19 Treatment, brand: Paxlovid, Treatment start date: 08May2022, Treatment stop date: 13May2022 lot number: unknown, indication: Treatment of COVID-19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Drug ineffective, Faeces discoloured, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Yellow stool; diarrhea; 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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 06Apr2021 as dose 1, single (Lot number: 036B21A), in right arm and on 06May2021 as dose 2, single (Lot number: 025C21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Known allergies: Sulfites" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D2, start date: 01Jan2021; FAMOTIDINE, start date: 01Jan2021; B12-VITAMIIN, start date: 12Jan2022; FOLIC ACID, start date: 01Jan2021; NORETHINDRONE [NORETHISTERONE], start date: 01Jan2021, stop date: 20May2022. The following information was reported: FAECES DISCOLOURED (non-serious) with onset 23May2022 at 11:00, outcome "unknown", described as "Yellow stool"; DIARRHOEA (non-serious) with onset 23May2022 at 11:00, outcome "unknown", described as "diarrhea"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 with Paxlovid (Lot number FY9918) from 21May2022 to 23May2022. Therapeutic measures were not taken as a result of faeces discoloured, diarrhoea.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot FH8020 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Sex: U
Vaccine: COVID19
Symptoms: Dry skin, Hypersensitivity, Pruritus, Skin burning sensation, Skin exfoliation
Clinical narrative: itching; burn; scaling; rough skin an allergic reaction; rough skin an allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 25Oct2021 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: covid-19 vaccine (Dose 1 Single, Manufacturer Unknown), administration date: 10Apr2021, for Covid-19 Immunization.  The following information was reported: PRURITUS (non-serious), outcome "not recovered", described as "itching"; SKIN BURNING SENSATION (non-serious), outcome "not recovered", described as "burn"; SKIN EXFOLIATION (non-serious), outcome "not recovered", described as "scaling"; DRY SKIN (non-serious), HYPERSENSITIVITY (non-serious), outcome "not recovered" and all described as "rough skin an allergic reaction".  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: Dizziness, Nausea, Vomiting
Clinical narrative: The next morning when I woke up I was extremely dizzy then I start vomiting and nausea from the dizziness; The next morning when I woke up I was extremely dizzy then I start vomiting and nausea from the dizziness; I guess is March 3rd I started to get dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prediabetic" (unspecified if ongoing), notes: Prediabetic. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 03Mar2022, outcome "not recovered", described as "I guess is March 3rd I started to get dizzy"; VOMITING (non-serious), NAUSEA (non-serious) all with onset 04Mar2022, outcome "unknown" and all described as "The next morning when I woke up I was extremely dizzy then I start vomiting and nausea from the dizziness". The events "i guess is march 3rd i started to get dizzy" and "the next morning when i woke up i was extremely dizzy then i start vomiting and nausea from the dizziness" required physician office visit. Therapeutic measures were taken as a result of dizziness, vomiting, nausea.  Additional information: Reporter stated that, all shots the first two in the beginning and then booster and second booster were all Pfizer shots. Patient had second booster on 29Apr which was the Friday. Sunday night on is 03Mar patient experienced dizzy. The next morning when she woke up, she was extremely dizzy then started vomiting and nausea from the dizziness. Patient had her 'PCP' who sent to PT, physical therapy and till this day they were still working on patient, and she still did not have all the dizziness gone and patient reported this to the people who gave the shot. Patient asked to help her to get rid of the dizziness. It's slowly going away but patient still have it. The physical therapist had been trying to help that to get this go away but for some reason it won't go anywhere.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 11:30 as dose 1, single (Lot number: EK9231), in left arm, on 10Feb2021 at 11:45 as dose 2, single (Lot number: EL8982), in left arm and on 26Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FH8020) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing), notes: prediabetes. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "known allergies codeine", notes: known allergies codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: she tested positive for Covid; she tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 as dose 2, single (Batch/Lot number: unknown), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 21Apr2022 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: CALCIUM; D3 VITAMIN; LIPITOR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "unknown" and all described as "she tested positive for Covid". The patient underwent the following laboratory tests and procedures: Pyrexia: (unspecified date) 99.1°F; SARS-CoV-2 antibody test: (23May2022) Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6202), on 24Mar2021 as dose 2, single (Lot number: ER8727) and on 10Sep2021 as dose 3 (booster), single (Lot number: KW0177) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogrens" (unspecified if ongoing); "Scleroderma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "cardiac vasospasm" (unspecified if ongoing); "Raynauds" (unspecified if ongoing); "PF due to SSc" (unspecified if ongoing), notes: PF due to SSc; "PF due to SSc" (unspecified if ongoing), notes: PF due to SSc. Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; LEVOTHYROXINE; WELLBUTRIN; CELLCEPT [MYCOPHENOLATE MOFETIL]; FLUOXETINE; ATORVASTATIN, stop date: 12May2022; AMLODIPINE, stop date: 12May2022. 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Known allergies was none.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 2, single (Lot number: Er8727), in left arm and on 02Nov2021 as dose 3 (booster), single (Lot number: Fe3592) at the age of 46 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: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "sickle cell trait" (unspecified if ongoing); "Severe allergies" (unspecified if ongoing); "Known allergies: I'm allergic to shellfish" (unspecified if ongoing); "Known allergies: cedar" (unspecified if ongoing); "Known allergies: pollen" (unspecified if ongoing); "Known allergies: dustmites" (unspecified if ongoing); "Known allergies: dander" (unspecified if ongoing). Concomitant medication(s) included: PATADAY taken for hypersensitivity; PRAVASTATIN taken for hypersensitivity; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. . Paxlovid taken as COVID 19 treatment from 05May2022 to 10May2022.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid 10May2022; Tested positive for Covid 10May2022; 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 59-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EP7533), in left arm and on 22Apr2021 as dose 2, single (Lot number: EN5318) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Dec2021 as dose 3 (booster), single (Lot number: 005C21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "gout" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Feb2022; ALLOPURINOL, start date: 02Jan2019. Past drug history included: Alleve, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "not recovered" and all described as "Tested positive for Covid 10May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive; (22May2022) Positive, notes: Tested positive in antigen test 22May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received other medication in 2weeks. Began Plaxlovid 11May2022. Symptoms resolved in 1-2 days. Finished dose pack 15May22. Good for several days. Attended work at office, cut the lawnall great 20May2022 or 21May2022 began having same symptoms, runny nose, congestion. Tested positive in antigen test 22May2022. Had suspended Crestor for high cholesterol when taking Plaxovid. Had the rebound effect.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 09Feb2021 as dose 2, single (Lot number: EN5318), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: FC3592) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: Other medication in 2 weeks was none. Known allergies were none.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: After paxlovid treatment tested covid negative on days 5, 6, 7, 8. On day 10 symptoms returned and tested positive for covid again. Currently day 14 and still positive.; After paxlovid treatment tested covid negative on days 5, 6, 7, 8. On day 10 symptoms returned and tested positive for covid again. Currently day 14 and still positive.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 21Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Postural tachycardia" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "After paxlovid treatment tested covid negative on days 5, 6, 7, 8. On day 10 symptoms returned and tested positive for covid again. Currently day 14 and still positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: After paxlovid treatment tested covid negative on days 5, 6, 7, 8. On day 10 symptoms returned and tested positive for covid again. Currently day 14 and still positive. Patient received vaccine. In 2 weeks no other medication was received by the patient. Patient have no known allergies. Paxlovid was taken from 10May2022 to 14May2022 for treatment of COVID-19 as an anti-viral.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 24Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Feb2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "very mild high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 01Jan2019.   The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results; (unspecified date) very positive Covid antigen test; (unspecified date) Still positive antigen test; (19May2022) Negative antigen; (20May2022) Negative; (21May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient took Paxlovid for covid-19 treatment from 08May2022 to 13May2022. Took five day Paxlovid course, symptoms improved, negative antigen test days 6, 7 and 8. Stuffy nose returned day 12, awoke day 13 to congestion, cough and brain fog, retested, very positive Covid antigen test. Cough progressed and worsened day 14. Still positive antigen test, congestion and cough today, day 16. Patient had no known allergies  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 05May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (14May2022) Negative, notes: Tested negative twice on final day of Paxlovid course (14May); (16May2022) Negative; (20May2022) Positive; (23May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received vaccine. The patient did not receive other medication in 2 weeks. Anti viral details: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date was 09May2022 and stop date was 14May2022. Adverse event: Tested negative twice on final day of Paxlovid course (Sat 14May), and then again on the following Monday (16May). I then experienced new symptoms starting evening of 18May, and tested positive again on 20May, with new anosmia. Continued to test positive through today, 23May. Adverse event start date was 18May2022 and the patient was recovering without ae treatment. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac function test, Chest discomfort, Dizziness, Polymerase chain reaction
Clinical narrative: a sudden onset of chest tightness; feeling of being light-headed and dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 at 18:00 as dose 2, single (Lot number: EL9261) at the age of 55 years, in right arm and on 19Nov2021 at 10:00 as dose 3, single (Lot number: FJ1620), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Poultry allergy" (unspecified if ongoing), notes: Poultry allergy. There were no concomitant medications. Past drug history included: Naproxen, reaction(s): "Allergy". Vaccination history included: coviD-19 pfizer vaccine (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Right, Vaccine Administration Time: 06:00 PM), administration date: 27Jan2021, for COVID-19 immunisation. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "a sudden onset of chest tightness"; DIZZINESS (non-serious), outcome "unknown", described as "feeling of being light-headed and dizzy". The events "a sudden onset of chest tightness" and "feeling of being light-headed and dizzy" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest discomfort, dizziness.  Additional Information: Within 3 months of receiving the 2nd/3rd dose of the vaccine I had multiple episodes (4) of a sudden onset of chest tightness and feeling of being light-headed and dizzy. The chest tightness would subside after about 30 minutes and the feeling of being light headed could last 1-6 hours. On 23May2022 patient did qRT-PCR (Nasal Swab) test and result was Positive. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, the patient been tested for COVID-19.On an unspecified date, patient underwent blood work result was unknown. Cardiac tests result was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: a sudden onset of chest tightness; feeling of being light-headed and dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 at 18:00 as dose 2, single (Lot number: EL9261) at the age of 55 years, in right arm and on 19Nov2021 at 10:00 as dose 3, single (Lot number: FJ1620), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Poultry allergy" (unspecified if ongoing), notes: Poultry allergy. There were no concomitant medications. Past drug history included: Naproxen, reaction(s): "Allergy". Vaccination history included: coviD-19 pfizer vaccine (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Right, Vaccine Administration Time: 06:00 PM), administration date: 27Jan2021, for COVID-19 immunisation. The following information was reported: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "a sudden onset of chest tightness"; DIZZINESS (non-serious), outcome "unknown", described as "feeling of being light-headed and dizzy". The events "a sudden onset of chest tightness" and "feeling of being light-headed and dizzy" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chest discomfort, dizziness.  Additional Information: Within 3 months of receiving the 2nd/3rd dose of the vaccine I had multiple episodes (4) of a sudden onset of chest tightness and feeling of being light-headed and dizzy. The chest tightness would subside after about 30 minutes and the feeling of being light headed could last 1-6 hours. On 23May2022 patient did qRT-PCR (Nasal Swab) test and result was Positive. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, the patient been tested for COVID-19.On an unspecified date, patient underwent blood work result was unknown. Cardiac tests result was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Mental disorder
Clinical narrative: himself is dealing with some mental illness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 23May2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:2, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose:1, unknown manufacturer), for COVID-19 Immunization. The following information was reported: MENTAL DISORDER (non-serious), outcome "unknown", described as "himself is dealing with some mental illness".  Additional information: Customer asked, so how can he see his results, customer confirmed that it was for his covid test result. Response was apologized and advised the caller that Pfizer does not have access to individual patients covid test result. Referred to medical facility where his covid test was taken. Consumer wanted to know if there would be some changes if his wife will not be getting the Pfizer BioNTech COVID-19 Vaccine booster dose (third shot). Yesterday, patient went and got a shot, it's his third one now. Patient was trying to see his results but they're not ready. But patient have been taking shots, himself and his wife together, every shot his wife took, he took,  they took it together. Now, he took one and patients wife says she is not taking another one. He mean is it possible that it's supposed to keep on going the same way it's been going. Because if they changed it, he gotta change then, right. This is serious, if patient got the shot, you need to get it again, not no problem, there's gonna be some change, real change. His wife don't want to take the other one (exact words were not clear during the recording, could be referring to the third shot of the Pfizer BioNTech COVID-19 Vaccine) but she's been taking the other one since (exact word was not clear during the recording) and she's younger than he was, but she should take it too, right. He was telling his wife, we've been taking the shot since we've been together and now she don't want to take the last one, are not she supposed to. Yeah, that's it and she got three. Therefore, she is gonna be different there too, because if she was with me, she won't take them there. She gonna have. This is gonna be a change right here, this is where the change coming at now. Caller's wife only took 2 shots of the Pfizer BioNTech COVID-19 vaccine and the last shot is last year (month was not disclosed by the caller). Caller also mentioned that he himself is dealing with some mental illness. Unable to obtain age information for caller. Offered to warm transfer to agent however caller stated that he doesn't want to talk about it when probed for more safety information.   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: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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., Manufacturer unknown), for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.