chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 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: "High cholesterol" (unspecified if ongoing), notes: High cholesterol managed with Atorvastatin, extra 15-20 pounds. Concomitant medication(s) included: ATORVASTATIN; TRAZODON, both received in 2 weeks around vaccination. Past drug history included: Percoset, reaction(s): "known allergies Percoset". 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: Positive, notes: positive test 6 days after completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
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 63-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). 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". 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.  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: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 69-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's Disease" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: It was reported other medication in 2 weeks: Yes. Adverse event reported congestion, fatigue, sore throat. The Covid-19 was treated with paxlovid from 15Jul2022 to 19Jul2022.  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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for 1 day 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) all with onset 2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Jul2022) Positive, notes: Symptoms then returned and I again tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Jul2022 to 14Jul2022. After completing treatment patient was symptom free for 3 full days. Symptoms then returned on 17Jul2022 and patient again tested positive. She considered it a rebound.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL8982), on 09Feb2021 as dose 2, single (Lot number: EM9809) and on 21Nov2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 30 years 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), outcome "unknown", described as "Vaccination failure "; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: diagnosed with Covid; (unspecified date) Positive, notes: I had Covid rebound and tested positive 9 day after being diagnosed with Covid; (22Jul2022) Negative, notes: I tested negative 6 days after starting paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient had no taken other medications in 2 weeks and known allergies was no.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 treatment, Drug ineffective, Off label use, Product use issue
Clinical narrative: COVID 19; COVID 19; breastfeeding a 2.5 year old; breastfeeding a 2.5 year old; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient had no Known allergies. There were no concomitant medications/No Other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19"; OFF LABEL USE (medically significant), PRODUCT USE ISSUE (medically significant), outcome "unknown" and all described as "breastfeeding a 2.5 year old". The patient underwent the following laboratory tests and procedures: COVID-19 treatment: Unknown results. Adverse event: The patient was breastfeeding a 2.5-year-old and no other outcome other than she says her milk is yucky for a few hours after each dose. She wanted to contribute to the data you have on the medicine and breastfeeding outcomes. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Anti-viral treatment and details included: Brand: Paxlovid, Treatment start date: 23Jul2022.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202201007667 mother/baby case;
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 at 16:30 as dose 1, single (Lot number: Cdr01413171), in right arm and on 15Feb2021 at 13:30 as dose 2, single (Lot number: Cdr0413180) at the age of 65 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: No other medication in 2weeks and no known allergies. Treatment medication for COVID 19 was Paxlovid and the treatment start date was on 07Jul2022 and the treatment stop date was on 11Jul2022.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, 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). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 11Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 24Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jul2022) Positive, notes: I have tested positive for COVID again on 25Jul2022 on two at home COVID tests; (21Jul2022) Negative, notes: after two negative at home tests on 21Jul2022; (22Jul2022) Negative, notes: One negative PCR test on 22Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Influenza like illness, Pyrexia
Clinical narrative: feeling like i have the flu with a full grade fever; feeling like i have the flu with a full grade fever; every time she receives the shot, the symptoms worsen; 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 54-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: FH8028) for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "each time, the symptoms or reaction was worst", "soreness". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "feeling like i have the flu with a full grade fever"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "every time she receives the shot, the symptoms worsen".  Additional information: As per agent (Name withheld), the patient experienced side effects from the COVID vaccine and wants to know if should proceed with the booster. Caller stated that she was solely vaccinated with the Pfizer COVID vaccine and each time, the symptoms or reaction was worst. Caller mentioned that first time 04 April, the second time it was a full blown feeling like i have the flu with a full grade fever, then the third time I had my ears swell up to the point you cannot hear in any ears now. Caller mentioned that seek urgent care and she was told never saw anything like that and to ER. Caller stated that ER said the same that they never saw anything like that. Caller added that after consultations was prescribed with a steroid drops and actually got hearing for about the week. Caller mentioned that now it is time for the second booster, is it advised to the second booster or switch to other vaccine. After providing response, caller stated that she thinks she fall under the category of those who shouldn't take the vaccine. Caller also mentioned that every time she receives the shot, the symptoms worsen. Caller also added that seek medical advise from her doctor and they didn't know what to do as well and referred to Pfizer. There were no relevant lab tests.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733), in right arm, on 09Apr2021 as dose 2, single (Lot number: EN6206), in left arm, on 11Oct2021 as dose 3 (booster) single (Lot number: FF8839), in left arm and on 22Apr2022 as dose 4 (booster) single (Lot number: FJ4989) at the age of 72 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: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19 from 15Jul2022 and 20Jul2022.  Clinical course: The patient had no known allergies. 5 days after taking a 5-day regimen of Paxlovid the patient started having sore throat, runny nose and mild fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
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) (Physician). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2021 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 included: "Long QT" (unspecified if ongoing). Concomitant medication(s) included: NADOLOL; LOESTRIN; ALLEGRA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201008094 same patient, different AE, different dose of vaccine;
Age: 59.0
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 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 09Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 59 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 included: "Asthma" (unspecified if ongoing); "Bladder Cancer" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Thrombocytosis" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish, Levaquin. The patient took concomitant medications. Patient received other medication in 2 weeks. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin", notes: Known allergies: Shellfish, Levaquin. 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: SARS-CoV-2 test: positive, notes: Treatment of COVID-19; negative, notes: positive Covid test after testing negative; positive, notes: positive Covid test after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment from 11Jul2022 to 15Jul2022. Adverse event: Experiencing Rebound Covid and positive Covid test after testing negative.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the parent). A 9-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jul 22, 2022, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. The patient experienced rash/a rash that hurts and pain; all onset Jul 2022, with outcome of unknown. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received. Sender's comments: Linked report: US-PFIZER INC-202201006357 (same  drug/reporter, different patient/AE).
Age: 64.0
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 14Apr2021 as dose 2, single (Lot number: 04B21A) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2000; MONTELUKAST, start date: 01Jan2020; LORATADINE, start date: 01Jan2000; AMLODIPINE, start date: 01Jan2020; FAMOTIDINE, start date: 01Jan2020; BUPROPION, start date: 01Jan2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (24Jul2022) Negative, notes: On 24Jul2022 covid test was negative; (25Jul2022) Positive, notes: On 25Jul2022 woke up with a sore throat, the covid test is positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.  Clinical information: COVID-19 Treatment included paxlovid from 15Jul2022 to 20Jul2022. Other medication in 2weeks included levothyroxine, Montelukast, loratadine, amlodipine, famotidine, bupropion.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  the reported events Vaccination failure , COVID-19  cannot be completely excluded based on temporal association and known drug safety profile
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), 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: FOSAMAX, start date: Feb2018, stop date: Feb2018; ZILEUTON, start date: Feb2014, stop date: Feb2014. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 22Jan2021, for COVID-19 immunization, reaction(s): "developed an escalation in the intensity of my (relatively minor) tinnitus". The following information was reported: TINNITUS (non-serious), outcome "not recovered". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: adverse event Approx three hours after receiving her first shot on 22Jan2021 she developed an escalation in the intensity of her (relatively minor) tinnitus. Noticed no difference after second Vax and first booster. But three hours after her second booster 08Apr2022 she experienced a very loud intensity of her tinnitus and it has not changed or subsided. This one was life altering. She do not plan to take any further covid treatments. Patient was received other medication in 2 weeks. 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: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZILEUTON, start date: Feb2014; FOSAMAX, start date: Feb2018. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 22Jan2021, when the patient was 65-year-old, for Covid-19 immunization, reaction(s): "developed an escalation in the intensity of my (relatively minor) tinnitus"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "tinnitus". The following information was reported: TINNITUS (non-serious), outcome "not recovered". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient had received other medication in 2 weeks. She had no known allergies. Approximately three hours after receiving her first shot on 22Jan2021 she had developed an escalation in the intensity of her (relatively minor) tinnitus. Noticed no difference after the second Vax and first booster. But three hours after her second booster 08Apr2022, she experienced a very loud intensity of her tinnitus and it has not changed or subsided. This one was life altering. She does not plan to take any further covid treatments.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZILEUTON, start date: Feb2014; FOSAMAX, start date: Feb2018. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 22Jan2021, when the patient was 65-year-old, for Covid-19 immunization, reaction(s): "developed an escalation in the intensity of my (relatively minor) tinnitus"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "tinnitus". The following information was reported: TINNITUS (non-serious), outcome "not recovered". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient had received other medication in 2 weeks. She had no known allergies. Approximately three hours after receiving her first shot on 22Jan2021 she had developed an escalation in the intensity of her (relatively minor) tinnitus. Noticed no difference after the second Vax and first booster. But three hours after her second booster 08Apr2022, she experienced a very loud intensity of her tinnitus and it has not changed or subsided. This one was life altering. She does not plan to take any further covid treatments.  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: Tinnitus
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: experienced a very loud intensity of my tinnitus and it has not changed or subsided; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ZILEUTON, start date: Feb2014; FOSAMAX, start date: Feb2018. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 22Jan2021, when the patient was 65-year-old, for COVID-19 immunization, reaction(s): "Developed an escalation in the intensity of my (relatively minor) tinnitus", "covid", "covid"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "covid", "Tinnitus"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "covid"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "covid", "Tinnitus"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "covid".  The following information was reported: TINNITUS (non-serious) with onset 08Apr2022, outcome "not recovered", described as "experienced a very loud intensity of my tinnitus and it has not changed or subsided". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: Patient did not have any known allergies. Approx three hours after receiving her first shot on 22Jan2021 She developed an escalation in the intensity of her (relatively minor) tinnitus. Noticed no difference after second Vax and first booster. But three hours after her second booster 08Apr2022 She experienced a very loud intensity of her tinnitus, and it has not changed or subsided. This one was life altering. She did not plan to take any further covid treatments.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 20May2022 at 14:30 as dose 4 (booster), single (Lot number: EW0150) at the age of 65 years, in right 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: "long covid from presumed infection", start date: Mar2020 (unspecifie d if ongoing), notes: long covid from presumed infection in Mar2020 (intestinal); "Hashimotos" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022 at 12:00, outcome "recovering" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Negative; (25Jul2022) Positive, notes: after 11 days of negative antigen tests; (25Jul2022) Positive; (25Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient have no known allergies.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Metamorphopsia
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 20May2022 at 14:30 as dose 4 (booster), single (Lot number: EW0150) at the age of 65 years, in right 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: "long covid from presumed infection", start date: Mar2020 (unspecifie d if ongoing), notes: long covid from presumed infection in Mar2020 (intestinal); "Hashimotos" (unspecified if ongoing). The patient's concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022 at 12:00, outcome "recovering" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Negative; (25Jul2022) Positive, notes: after 11 days of negative antigen tests; (25Jul2022) Positive; (25Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient have no known allergies.
Age: 62.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ERB737), in left arm, on 22Apr2021 as dose 2, single (Lot number: EWO170), in left arm and on 27Oct2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOVASTATIN, start date: 01Sep2015, stop date: 12Jul2022; LOSARTAN, start date: 01Sep2015; HYDROCHLOROTHIAZIDE, start date: 01Sep2015. The following information was reported: COVID-19 (medically significant) with onset 12Jul2022, outcome "not recovered"; VACCINATION FAILURE (medically significant) with onset 12Jul2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive; (25Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Acute myocardial infarction, Laboratory test
Clinical narrative: STEMI heart attack; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  A 68-year-old male patient received BNT162b2 (BNT162B2), on 30Jun2022 at 14:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 68 years, in left arm for covid-19 immunisation; atorvastatin calcium (LIPITOR), (Batch/Lot number: unknown) at low dose. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (1st vaccine 27Dec2020 Lot - unknown. Injected in left arm.), administration date: 27Dec2020, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "Covid-19"; BNT162b2 (2nd vaccine given on 20Jan2021, Lot EL9262, or EL9161 Expiration is unknown. Injected Left arm. ), administration date: 20Jan2021, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "Covid-19"; BNT162b2 (3rd dose , 1st booster, given on 09Oct2021 Lot FF8839 expiration of 31Dec2021, injected in left arm.), administration date: 09Oct2021, when the patient was 67-year-old, for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: ACUTE MYOCARDIAL INFARCTION (hospitalization) with onset 16Jul2022, outcome "recovered with sequelae", described as "STEMI heart attack". The patient was hospitalized for acute myocardial infarction (start date: 16Jul2022). The event "stemi heart attack" required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab Test: (Apr2022) Normal. The action taken for atorvastatin calcium was unknown.  Additional information: On 16Jul2022, he had a STEMI heart attack. He survived that.  He had a complete blockage of LAD and has no prior history of heart disease. He survived because his collateral arteries were so good. He had no sign of heart disease. Is not hypertensive, and is on a low dose of Lipitor. Outcome: Recovered with lasting effects and it is somewhat unknown. An item of both. He was working for his former employer and this occurred on an airplane and he is pulmonary critical care. It depends on his heart remodels and his Ejection fraction and he is compromised.  Procedure was that he had a stent placed in his LAD and it was on 16Jul2022.  Reason why reporting is they had friend who was a gastroenterologist who had a cardiac event after receiving the COVID vaccine. She does not know if he reported. Neither one of them had any heart issues. He said that should not have happened to me.  She did not wish to complete report for him.
Age: 74.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: F14989) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Mar2017, stop date: Jul2022; NATURE MADE C, start date: Jan2010, stop date: Jul2022; NATURE MADE CALCIUM, start date: Jan2010, stop date: Jul2022; NATURE MADE VITAMIN D3, start date: Jan2010, stop date: Jul2022; NATURE MADE FOLIC ACID, start date: Jan2010, stop date: Jul2022. 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. Clinical course: Treatment received for COVID-19 as Paxlovid from 14Jul2022 to 18Jul2022.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive rapid antigen test for COVID-19 on 10Jul2022; positive rapid antigen test for COVID-19 on 10Jul2022; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 21Jan2021 as dose 2, single (Lot number: 5L3302), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Apr2022 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cardiomyopathy" (unspecified if ongoing); "BPH" (unspecified if ongoing), notes: BPH; "osteoarthritis" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jul2022, outcome "recovered" (22Jul2022) and all described as "positive rapid antigen test for COVID-19 on 10Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive, notes: positive rapid antigen test for COVID-19 on 10Jul2022; (11Jul2022) Positive, notes: RA test pos 11Jul2022, 12Jul2022, 13Jul2022 and 14Jul2022; (12Jul2022) Positive; (13Jul2022) Positive; (14Jul2022) Positive; (15Jul2022) Negative, notes: RA test neg 15Jul2022 and 16Jul2022; (16Jul2022) Negative; (19Jul2022) Positive, notes: RA test positive 19Jul2022; (20Jul2022) Positive, notes: RA test positive 20Jul2022 and 21Jul2022; (21Jul2022) Positive; (22Jul2022) Negative, notes: RA test negative 22Jul2022, 23Jul2022, 24Jul2022, 25Jul2022 and 26Jul2022; (23Jul2022) Negative; (24Jul2022) Negative; (25Jul2022) Negative; (26Jul2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid 10Jul2022, took first dose 09:00, completed 5-day course as prescribed, Treatment stop date 14Jul2022 and then second course of Paxlovid treatment started.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure and Covid 19, and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoacusis, Pruritus, Rash
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 83-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing), notes: on thyroid pills; "blood pressure" (unspecified if ongoing), notes: On some blood pressure pills and few other medication. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 02Feb2021, when the patient was 82-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 26Feb2021, when the patient was 82-year-old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "not recovered", described as "itch"; RASH (non-serious) with onset 2021, outcome "not recovered"; CONDITION AGGRAVATED (non-serious) with onset 2022, outcome "not recovered", described as "It has worsened over the last 2-3 weeks"; HYPOACUSIS (non-serious), outcome "unknown", described as "hard of hearing". Additional information: He asked his primary care doctor and he told him he thought it would be a good idea to get the COVID vaccines. The patient just thought the rash and itch would go away. He had a rash and an itch that started sometime after he took the booster dose of the vaccine. It didn't start right now. It got a little better and then came back. Over the last 3-4 weeks, it got really bad. He had no bumps it just itches. It had worsened over the last 2-3 weeks. He hasn't received his pneumonia or flu shot. At first it wasn't that bad. It was just a little itch. It was not like it was now. He had it every day and night now. It doesn't last all day and night but always comes back. It was also reported that he was hard of hearing. He was on some Blood pressure pills and few other medications. He had little issues before, but it usually goes away. Nothing had been as bad as this one. He doesn't know if any of his medications have anything to do with it. He was on thyroid pills. He was on something to help him relax and rest if he needs it. He takes those more often. Vaccine was administered on left shoulder. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). The patient had no investigations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: SARS-CoV-2 test positive; SARS-CoV-2 test positive; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "SARS-CoV-2 test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: The patient received COVID 19 Treatment (Paxlovid).  Follow up information has been requested.
Age: 67.0
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) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 at 11:00 as dose 1, single (Lot number: EL9264), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 01Oct2021 at 14:00 as dose 3 (booster), single (Lot number: ER8732), in left arm and on 18Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: YUVAFEM, start date: 12Jul2022, stop date: 12Jul2022; VITAMIN D NOS, start date: 13Jul2022, stop date: 13Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included with Paxlovid. Clinical Course: It was reported that rebound Covid symptoms (runny nose, fatigue, sore tongue) began on 23Jul2022. Paxlovid for initial infection completed morning of 19Jul2022 and all Covid symptoms were gone at this point.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events  Vaccination failure, COVID-19 and the suspect drug BNT162B2.