chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 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 had no relevant medical history. Concomitant medication(s) included: PROGESTERONE, start date: 01Jul2021, stop date: 28Jul2022; SERTRALINE, start date: 02May2021, stop date: 28Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: 2 days after Paxlovid, patient's symptoms came back.  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 available information causal association between the reported events and suspect drug cannot be totally excluded
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; 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 35-year-old female patient received BNT162b2 (BNT162B2), on 06Jul2022 as dose 5 (booster), single (Lot number: FM7553) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing); "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 27Jul2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Negative; (29Jul2022) Positive, notes: Testing positive again on 07/29. Runny nose is main symptom. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. The patient was started on anti viral drug Paxlovid from start date: 19Jul2022 to treatment stop date: 23Jul2022.  Clinical information: The patient had no known allergies. The patient had Rebound symptoms beginning 27Jul2022. Tested negative on 23Jul2022. Testing Positive again on 29Jul2022). Runny nose was main symptom.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 12Mar2022 at 13:00 as dose 2, single (Lot number: 1823), in left arm, on 02Apr2022 at 13:00 as dose 3 (booster), single (Lot number: 1900), in left leg and on 15May2022 at 16:00 as dose 4 (booster), single (Lot number: FW8703) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). Concomitant medication(s)/Other medication in 2weeks included: FLONASE [MOMETASONE FUROATE], start date: 01Jul2022, stop date: 25Jul2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jul2022, stop date: 25Jul2022. Past drug history included: Demerol, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. After 3 days on medicine had terrible nausea had to fight not to throw up. symptoms running nose soar throat cough got better  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 29.0
Sex: M
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 29-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 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: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 20Jul2022, stop date: 24Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19  (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: it was reported that Covid-19 treatment (Paxlovid) started at 21Jul2022 and stopped at 25Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody 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 47-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 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 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 antibody test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 14Jul2022, he started Paxlovid for COVID-19 Treatment and stopped on 19Jul2022. On 24Jul2022, he had rebound of Covid 5 days after treatment end. It was unknown if treatment received for AE or not. He was recovering from AE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 at 17:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Citrus" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; ESOMEPRAZOLE; VYVANSE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jul2022) Negative, notes: I tested negative on days 3, 4, and 7 of paxlovid course; (22Jul2022) Negative, notes: I tested negative on days 3, 4, and 7 of paxlovid course; (25Jul2022) Negative, notes: I tested negative on days 3, 4, and 7of paxlovid course; (29Jul2022) Positive, notes: I tested positive on day 11, 6 days after completing the medicine. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient took antiviral as treatment for covid-19 from 19Jul2022 to 23Jul2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 62-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), 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: Rebound COVID symptoms following negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm, as dose number unknown, single (Batch/Lot number: unknown), in left arm and as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Undifferentiated Spondyloarthritis." (ongoing), notes: A monthly injection of Cosentyx was taken 18Jul2022. Concomitant medication(s) included: COSENTYX taken for undifferentiated spondyloarthritis, start date: 18Jul2022. Past drug history included: Knonwn allergies: morphine, reaction(s): "Knonwn allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included that the patient started paxlovid for the treatment of COVID-19 on 18Jul2022 and Treatment stopped on 22Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Swelling face
Clinical narrative: Facial swellings; shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 at 09:00 as dose 1, 0.3 ml single (Lot number: FJ1620) at the age of 37 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SWELLING FACE (hospitalization) with onset 15Dec2021, outcome "not recovered", described as "Facial swellings"; DYSPNOEA (hospitalization) with onset 15Dec2021, outcome "not recovered", described as "shortness of breath". The patient was hospitalized for swelling face (hospitalization duration: 3 day(s)); the patient was hospitalized for dyspnoea (hospitalization duration: 3 day(s)). The events "facial swellings" and "shortness of breath" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of swelling face, dyspnoea. Clinical course: The patient had no other vaccine in four week and no other medication in two week. Patient had not tested covid post vaccination. The patient had no known allergies.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: recieved 4 doses of the Pfizer Covid 19 Vaccines/to start Paxlovid since he has been taking the other medication; recieved 4 doses of the Pfizer Covid 19 Vaccines/to start Paxlovid since he has been taking the other medication; 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), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "Heart attack" (unspecified if ongoing). Concomitant medication(s) included: COLCHICINE taken for gout; BRILINTA taken for myocardial infarction. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "recieved 4 doses of the Pfizer Covid 19 Vaccines/to start Paxlovid since he has been taking the other medication". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical course: The patient takes Colchicine that is optional for his gout. He also takes Brilinta 1/2 dose due to his heart attack 12 months ago. Caller was inquiring on how much time does he needs to be off on blood thinner before he can take Paxlovid.  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: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 25Apr2021 as dose 2, single (Lot number: ER8735), in left arm and on 09Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRAVASTATIN, start date: Jan2008; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2008. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Negative; (15May2022) Negative; (17May2022) Positive; (19May2022) Positive; (20May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Completed Paxlovid treatment 11May. Symptoms were obviously improving and patient tested Negative on 14May afternoon, and Negative again May 15 morning. On the morning of 17May patient had a runny nose and a light cough. He tested POSITIVE again that morning. Symptoms of runny nose, light cough, fatigue (but no fever) continued for about 4 more days. He tested POSITIVE 19May and 20May. If patient recovered: Recovered. Adverse event stop date: 21May2022  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: I have the stomach trouble; its been really bad stomach; its the reaction from the second booster; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jul2022 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; Covid-19 vaccine (FIRST BOOSTER, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset Jul2022, outcome "unknown", described as "Diarrhea"; ABDOMINAL DISCOMFORT (non-serious) with onset Jul2022, outcome "unknown", described as "I have the stomach trouble; its been really bad stomach; its the reaction from the second booster".  Additional information: Reporter stated that had second booster last Friday and had stomach trouble ever since and talked to two nurses they thought its the reaction from the second booster. It had been a week tomorrow. Yes, because its been really bad stomach Saturday and then some diarrhea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
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 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 09Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in right arm for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM; LARISSIA; ALEVE-D SINUS & COLD. The following information was reported: DRUG INEFFECTIVE (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: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received other medications within 2 weeks of vaccination. The patient received treatment with Paxlovid (lot number: 1917995A) from 28Jul2022 to 29Jul2022 for Covid-19. No known allergy reported. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 01Feb2022 at 07:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunization; 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 immunization. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing), notes: Other medical history: Crohn's disease; Breast Cancer; "Breast Cancer" (unspecified if ongoing), notes: Other medical history: Crohn's disease; Breast Cancer. Concomitant medication(s) included: SYNTHROID; TAMOXIFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Negative, notes: Finished five day course, tested negative for five days after; (29Jul2022) positive, notes: Tested positive on day six. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2weeks (Synthroid, Tamoxifen).  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, SARS-CoV-2 test, 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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EW6205), in right arm, on 25Mar2021 as dose 2, single (Lot number: ER8732), in right arm, on 23Sep2021 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 22Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "low thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; DULOXETINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". Clinical course: anti viral details; product: COVID 19 Treatment, brand: Paxlovid; treatment start date: 16Jul2022, treatment stop date: 21Jul2022, indication: Treatment of COVID-19. Adverse event: After 5days on Paxlovid, I tested negative and felt better. 5 days later, I had symptoms again, retested and was positive. After 5 more days of isolation I still have symptoms. patient known allergies was No. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (21Jul2022) Negative, notes: After 5 days on Paxlovid, she tested negative; (26Jul2022) Positive, notes: 5 days later, she had symptoms again, retested and was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 56.0
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 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 2, single (Lot number: EN6198) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Dec2021 as dose 3 (booster), single (Lot number: 032h21a) 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: "BMI 26" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing). Concomitant medication(s) included: ESTRACE; PROVERA. 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: Body mass index: 26, notes: Unit not mentioned only digit captured; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient had no known allergies. The patient took treatment for Covid-19 with Paxlovid on 27Jul2022. The patient has taken 4 doses of Paxlovid. Last night she took the dose at 7:30 pm.
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Tremor
Clinical narrative: About 2 months after the 2nd shot she started to have tremors and seizures.; About 2 months after the 2nd shot she started to have tremors and seizures.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A 17-year-old female patient received BNT162b2 (COMIRNATY), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE (both the Pfizer shot last year)), administration date: 2021, for Covid-19 immunization. The following information was reported: SEIZURE (medically significant), TREMOR (non-serious), outcome "unknown" and all described as "About 2 months after the 2nd shot she started to have tremors and seizures.". Clinical course: it was reported that, about 2 2 months after the 2nd shot she started to have tremors and seizures, where before the shots none of these happened.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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.  The following information was reported: DRUG INEFFECTIVE (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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that patient received treatment of Paxlovid for COVID-19 from 17Jul2022 to 21Jul2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
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) (Consumer or other non HCP). The reporter is the patient. A 39-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years for Covid-19 immunisation; CoviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 12Jul2022 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) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL; FLONASE [FLUTICASONE PROPIONATE]; VITAMIN D [VITAMIN D NOS]; VITAMIN C [ASCORBIC ACID]; PROBIOTICS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: On unknown date patient was tested positive and took Paxlovid treatment; (17Jul2022) Negative; (19Jul2022) Negative; (22Jul2022) Negative; (28Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: Product=COVID 19 Treatment, Paxlovid, start date=12Jul2022, stop date=17Jul2022. Other medication in 2 weeks product=Fish Oil, Flonase, Vitamin D, Vitamin C and Probiotics. Adverse event: Tested negative after Paxlovid treatment on 17Jul, full recovered and tested negative again on 19Jul and 22Jul. Symptoms came back and tested positive on 28Jul. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 11Apr2021 as dose 2, single (Lot number: EW0153), in left arm, on 15Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 15Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (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, notes: Recurrence of positive test and minor COVID symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No known allergy.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: En6203) and on 23Mar2021 as dose 2, single (Lot number: En6207) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Dec2021 as dose 3 (booster), single (Lot number: 033F21A) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient is expected to deliver a baby(s) on 08Oct2022. Concomitant medication(s) included: SERTRALINE; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]; MUCINEX. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was pregnant. Delivery date was provided as 08Oct2022. The patient received treatment from 12Jul2022 to 16Jul2022 for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; 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 female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset May2022, outcome "unknown", described as "Shingles".  Additional information: Reporter was a female patient, who reports that she has received both Pfizer COVID-19 vaccines and booster dose as well (no dates provided). Reporter reports that she had shingles in May2022. Reporter was asking if Shingrix was made by Pfizer? Reporter was asking if another shingles vaccine that starts with a "P" or a "T" is manufactured by Pfizer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via COVID-19 Adverse Event Self-Reporting Solution. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jul2022 at 14:00 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Cirrhosis of Liver" (unspecified if ongoing), notes: Other medical history: Cirrhosis of Liver. There was no known drug allergies. Concomitant medication(s) included: CIPROFLOXACIN; FUROSIMIDE. Vaccination history included: BNT162b2 (Vaccine Brand: Pfizer, Dose Number: 1, Vaccine Administration Date: 02Jul2022, Vaccine Administration Time: 01:00PM, Batch/lot number: Unknown, Unable to locate or read the details, Location of Injection: Arm Right), administration date: 02Jul2022, when the patient was 54-year-old, for COVID-19 Immunization. The following information was reported: DEATH (death, hospitalization) with onset 23Jul2022 at 22:00, outcome "fatal", described as "Died 36 hours later". The patient was hospitalized for death (hospitalization duration: 1 day(s)). The event "died 36 hours later" required emergency room visit. Therapeutic measures were taken as a result of death. Details were as follows: the patient died on 23Jul2022, at 10:00 pm. This resulted in a day of hospitalization. Treatment included ventilator/life support. The was no noted Covid prior vaccination, and the patient was not Covid tested post vaccination. The patient date of death was 25Jul2022. The reported cause of death was unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Reported Cause(s) of Death: Died 36 hours later.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for the COVID-19 virus; Tested positive for the COVID-19 virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 at 14:00 as dose 1, single (Lot number: EN6203), in left arm, on 30Mar2021 at 08:00 as dose 2, single (Lot number: EL3248), in left arm and on 13Dec2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 44 years, in left arm, all intramuscular 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), COVID-19 (medically significant) all with onset 29Jul2022, outcome "recovering" and all described as "Tested positive for the COVID-19 virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Negative; (29Jul2022) Positive; (30Jul2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: If other vaccine in four weeks and other medications in two weeks were reported as no. No Covid prior vaccination and no known allergies. Covid was tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 at 12:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05May2021 at 13:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Nov2021 at 16:30 as dose 3 (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: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Rebound. Symptoms reoccurred after treatment and were worse than original symptoms. Still had symptoms on day 14 and testing strongly positive. Rebound symptoms after Paxlovid started on 26Jul2022 9:00 AM leading to Prolongation of existing hospitalization (treatment received during existing hospitalization).  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 available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure  is : expected. The case will be reassessed further upon receipt of additional information.
Age: 64.0
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 64-year-old male patient received BNT162b2 (BNT162B2), on 25May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid was given as a treatment for Covid-19 from 21Jul2022 to 25Jul2022. Patient does not have any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: Fg3527) 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish; "Known allergies: mushrooms" (unspecified if ongoing), notes: Known allergies: mushrooms; "Known allergies: bee stings" (unspecified if ongoing), notes: Known allergies: bee stings. Concomitant medication(s) included: SERTRALINE, start date: 14Oct2020. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, 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 covid-19.
Age: 59.0
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0151), in left arm, on 19Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 15May2022 at 12:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient reported that the patient received no other medication in 2 weeks of vaccine. The patient received Anti viral details as follows, product=COVID 19 Treatment, Brand=paxlovid, Treatment start date=15Jul2022, Treatment stop date=19Jul2022, Indication=Treatment of COVID-19. Known allergies: Codeine. Other medical history: None.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EH9899), in left arm, on 10Feb2021 as dose 2, single (Lot number: EK4176), in left arm and on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Gold" (unspecified if ongoing), notes: Allergies: Gold; "known Allergy: Manganese" (unspecified if ongoing), notes: known Allergy: Manganese. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: followed by positive antigen test; (Jul2022) Positive, notes: positive COVID test; (Jul2022) Negative, notes: Two negative antigen tests day 8 and 9; (Jul2022) Negative, notes: Two negative antigen tests day 8 and 9. Therapeutic measures were taken as a result of covid-19. The patient received other medication that was anti-viral product Paxlovid (start date: 17Jul2022 to stop date: 22Jul2022) for treatment of covid-19 and Claritin D (details unspecified) within 2 weeks.   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, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EJ1685), on 13Jan2021 as dose 2, single (Lot number: EJ1686), on 12Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 24Jul2022 at 11:00 as dose 4 (booster), single (Lot number: FP7139) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 26Jul2022 to 27Jul2022 for the treatment of COVID-19.; Sender's Comments: Based on known drug safety profile and temporal association, there is reasonable possibility of causal association reported between the events and the suspect drug BNT162B2