chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 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); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Peanuts" (unspecified if ongoing), notes: Known allergies: Peanuts; "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish. Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 01May2022; BENADRYL, start date: 02May2022. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Ceclor. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Tested negative after taking Paxlovid days 6 thru 9; (May2022) Negative, notes: Tested negative after taking Paxlovid days 6 thru 9; (May2022) Negative, notes: Tested negative after taking Paxlovid days 6 thru 9; (May2022) Negative, notes: Tested negative after taking Paxlovid days 6 thru 9; (May2022) Positive, notes: Now testing positive day 10. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Adverse event: Tested negative after taking Paxlovid days 6 thru 9. Now testing positive day 10. Device Date:16May2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) 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) all with onset 03May2022, outcome "not recovered" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) negative; (11May2022) negarive; (12May2022) Positive; (13May2022) Positive; (14May2022) Positive; (15May2022) Positive; (16May2022) Positive; (03May2022) Positive, notes: started taking Paxlovid the day after tested positive for Covid. Therapeutic measures were taken as a result of covid-19. Clinical course: No other medication in 2 weeks. COVID 19 Treatment: Paxlovid. Treatment start date: 04May2022 and stop date: 08May2022. Patient started taking Paxlovid the day after patient tested positive for Covid (day 1). Patient completed the Paxlovid course on day 5. By day 7, patient was testing negative for COVID on home antigen tests, patient remained negative on day 8 but on day 9 patient was testing positive again. On day 10/11/12/13 patient remained antigen positive  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive Covid-19 rapid tests; Positive Covid-19 rapid tests; 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 01Apr2021 at 08:30 as dose 1, single (Lot number: EW0150), in left arm and on 22Apr2021 at 08:30 as dose 2, single (Lot number: E0161) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Dec2021 at 08:30 as dose 3 (booster) single (Lot number: 045J21A) for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing), notes: Vaccine brand other: Moderna, Vaccine dose number: 3. Concomitant medication(s) included: SAFYRAL, start date: 01May2022, stop date: 16May2022; ZINC, start date: 03May2022, stop date: 16May2022; STAR, start date: 03May2022, stop date: 16May2022; VIT C, start date: 03May2022, stop date: 16May2022; VIT D3, start date: 03May2022, stop date: 16May2022; IBUPROFEN; GREY; BAYER; NUTRINOCHE; BARLOW HERBS; EAST STAR; MUNITY BOOST; LDM-100. Past drug history included: Amoxicillin, reaction(s): "Known Allergies: Amoxicillin". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Positive Covid-19 rapid tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Positive Covid-19 RAPID tests from Company (BinaxNow), FlowFlex, iHealth. Therapeutic measures were taken as a result of covid-19, drug ineffective.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: high fever (102 degrees); This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  An 85-year-old male patient received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (1st booster), Manufacturer unknown), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fever (102 degrees)". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient experienced high fever (102 degrees) after 2nd Covid booster shot (4th shot in series). Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: mild sx and positive Ag test; mild sx and positive Ag test; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL3247), on 25Feb2021 as dose 2, single (Lot number: EL3247), on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15May2022, outcome "unknown" and all described as "mild sx and positive Ag test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive, notes: COVID test post vaccination COVID test type post vaccination=Unknown.  Additional information: If Other vaccine in four weeks: No, Adverse event: Travel to withheld and 1 day after return mild sx and + Ag test. If COVID prior vaccination: Unknown. If COVID tested post vaccination: Yes. COVID test post vaccination COVID test type post vaccination: Unknown. COVID test name post vaccination=Home Ag, COVID test date=15May2022, COVID test result=Positive  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events vaccination failure and covid-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19/ tested positive for Covid again; COVID 19/ tested positive for Covid again; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "high cholesterol" (unspecified if ongoing); "gerd" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Avelox, reaction(s): "Known allergies: Avelox"; Amitryptaline, reaction(s): "Known allergies: amitryptaline", notes: amitryptaline.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19/ tested positive for Covid again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: tested positive for Covid again. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: The patient received treatment with Paxlovid Pfizer, date of start of drug: 03May2022, date of last administration: 08May2022. The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. Five days after completion of the 5-day course of Paxlovid for treatment of Covid (and feeling well for 4 days), she developed symptoms (headache, sneezing, head congestion, lethargy) and tested positive for Covid again. She received treatment for those adverse events with OTC medications to treat symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Body ache; Headache; Chill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 14May2022 at 14:00 as dose 1, single (Lot number: FM1553) at the age of 50 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LOSARTAN; ROSUVASTATIN. The following information was reported: PAIN (non-serious) with onset 15May2022 at 03:00, outcome "recovering", described as "Body ache"; CHILLS (non-serious) with onset 15May2022 at 03:00, outcome "recovering", described as "Chill"; HEADACHE (non-serious) with onset 15May2022 at 03:00, outcome "recovering". Therapeutic measures were not taken as a result of pain, headache, chills.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Received my positive test; Received my positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: Unknown) at the age of 46 years for covid-19 immunisation, Covid-19 manufacturer unknown (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 relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Received my positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: started taking Paxlovid the day I received my positive test; (2022) Negative, notes: took it for 5 days and tested negative (antigen) on day 6. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient have not received any other medication in 2 weeks. Adverse event: Paxlovid Rebound! I started taking Paxlovid the day I received my positive test. I took it for 5 days and tested negative (antigen) on day 6. On day 11 I started feeling very tired, then a runny nose on day 14. I'm on Day 15 and still congested and tired, achy. start date of events was 13May2022 at 03:30 PM. The patient was treated with paxlovid from 04May2022 to 08May2022 for treatment of covid-19.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, Investigation
Clinical narrative: she asymptomatically tested positive; she asymptomatically tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 45-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247) and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 44 years 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), ASYMPTOMATIC COVID-19 (medically significant) all with onset 09May2022, outcome "unknown" and all described as "she asymptomatically tested positive". The patient underwent the following laboratory tests and procedures: Home AG: (09May2022) Positive, notes: COID test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of asymptomatic covid-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Dyspepsia, Head discomfort
Clinical narrative: felt like she had a hard area in her stomach; dizzy; stomach was hot like a fire; felt like she had something going on up in her head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), 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: ABDOMINAL DISCOMFORT (non-serious), outcome "recovered", described as "felt like she had a hard area in her stomach"; DIZZINESS (non-serious), outcome "recovered", described as "dizzy"; DYSPEPSIA (non-serious), outcome "recovered", described as "stomach was hot like a fire"; HEAD DISCOMFORT (non-serious), outcome "recovered", described as "felt like she had something going on up in her head".  Additional Information: Caller has a complaint about Pfizer . She took the COVID vaccine.most like 7 months ago.She has had a headache since her second dose 05Oct2021.Every day since, she has had a headache. She has seen the doctors. Six to seven months is a long time.  She has called before. She saw her primary doctor, and another doctor for the issue with her head. It is not like a normal headache.  gave her a paper after her first dose with an appointment for her second dose.Even the guy asked her health history. She doesn't have a health history.After the first dose , she felt like she had a hard area in her stomach. It was not normal . That started about 5-6 minutes after the first dose. She was dizzy, her stomach was hot like a fire. She sat 15 minutes, and it went away. Then it was gone.But during that time she felt like she had something going on up in her head.Everything was gone 15-20 minutes later.Then, she took the second dose on 05Oct2021.She developed a really weird Headache. It would not leave her alone.She took Tylenol and Advil, and neither made the headache go away. She doesn't have NDC/lot/expiration. She has seen the doctor. Her headache has stayed.The first day after the second dose, she took Advil because she didn't want a headache or fever.She felt the headache 3 days later, and it hasn't stopped since. She is going to go crazy.The doctor has checked her blood work and everything is fine. Description of Product Complaint: Description of complaint:  She took Tylenol and Advil, and neither made the headache go away. She doesn't have NDC/lot/expiration. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
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). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 25Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing), notes: other medical history: Coronary artery. Concomitant medication(s) included: ATORVASTATIN; BABY ASPIRIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (15May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Swelling
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2022 at 11:45 as dose 1, single (Lot number: 59267-1025-01) at the age of 47 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: ADVIL [IBUPROFEN]. The following information was reported: PAIN (non-serious) with onset 14May2022 at 18:00, outcome "not recovered", described as "Soreness and swelling under left armpit"; SWELLING (non-serious) with onset 14May2022 at 18:00, outcome "not recovered", described as "swelling under left armpit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, swelling. Additional information: Patient did not received any other vaccine in four weeks. Patient did not have any known allergies.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 positive on rapid antigen test after receiving 3 doses of Comirnaty; COVID-19 positive on rapid antigen test after receiving 3 doses of Comirnaty; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 13-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for 1 day, as dose 2, single (Batch/Lot number: unknown) for 1 day and as dose 3 (booster), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19 positive on rapid antigen test after receiving 3 doses of Comirnaty". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.COVID-19 positive on rapid antigen test after receiving 3 doses of Comirnaty. He is 13 and otherwise in good health.Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 positive on rapid antigen test with compatible symptoms; COVID-19 positive on rapid antigen test with compatible symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19 positive on rapid antigen test with compatible symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events drug ineffective and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain". 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-202200722447 different patient, same drug and event.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Candida infection, Chest pain, Ear pain, Gastrooesophageal reflux disease, Muscle spasms
Clinical narrative: She was positive for COVID; She was positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0169), in left arm, on 14May2021 as dose 2, single (Lot number: EW0185), in left arm and on 18Feb2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "unknown" and all described as "She was positive for COVID". The event "she was positive for covid" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test positive: (unspecified date) Positive; SARS-CoV-2 test: (10May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Two weeks ago she was diagnosed with thrush. She had throat and neck pain right after her COVID booster. It was a few days later after the COVID booster. She had chest pain. It radiated up to her neck, jaw, and ear. Every day she was going through it. She would take Tylenol for it, but it was not helping much. She doesn't have the NDC/lot/expiration for the Tylenol. She also tried Motrin. To try to figure out which would work best. She went to the Emergency room because she was nervous it could be her heart. They said she was having a muscle spasm and an acid reflux attack. She has a history of GERD and throat reflux. She just hasn't been on medication for it. Since she was boosted and everything. She took Tylenol and Pepcid AC. She just takes it here and there. It was necessary. She definitely took it when she was in pain. She is on medication for that thrush too now. The day she was diagnosed on a rapid was on Tuesday, and she saw her doctor then. She had to get a doctor's note saying she was positive for COVID so she could get COVID pay. prior Vaccinations (within 4 weeks): not provided. Patient's Medical History (including any illness at time of vaccination): Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: no. Relevant Tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI): no. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Oropharyngeal pain, Pain, Pain in jaw
Clinical narrative: She was positive for COVID; She was positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0169), in left arm, on 14May2021 as dose 2, single (Lot number: EW0185), in left arm and on 18Feb2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "unknown" and all described as "She was positive for COVID". The event "she was positive for covid" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test positive: (unspecified date) Positive; SARS-CoV-2 test: (10May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Two weeks ago she was diagnosed with thrush. She had throat and neck pain right after her COVID booster. It was a few days later after the COVID booster. She had chest pain. It radiated up to her neck, jaw, and ear. Every day she was going through it. She would take Tylenol for it, but it was not helping much. She doesn't have the NDC/lot/expiration for the Tylenol. She also tried Motrin. To try to figure out which would work best. She went to the Emergency room because she was nervous it could be her heart. They said she was having a muscle spasm and an acid reflux attack. She has a history of GERD and throat reflux. She just hasn't been on medication for it. Since she was boosted and everything. She took Tylenol and Pepcid AC. She just takes it here and there. It was necessary. She definitely took it when she was in pain. She is on medication for that thrush too now. The day she was diagnosed on a rapid was on Tuesday, and she saw her doctor then. She had to get a doctor's note saying she was positive for COVID so she could get COVID pay. prior Vaccinations (within 4 weeks): not provided. Patient's Medical History (including any illness at time of vaccination): Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: no. Relevant Tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI): no. No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test positive, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She was positive for COVID; She was positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0169), in left arm, on 14May2021 as dose 2, single (Lot number: EW0185), in left arm and on 18Feb2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "unknown" and all described as "She was positive for COVID". The event "she was positive for covid" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test positive: (unspecified date) Positive; SARS-CoV-2 test: (10May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Two weeks ago she was diagnosed with thrush. She had throat and neck pain right after her COVID booster. It was a few days later after the COVID booster. She had chest pain. It radiated up to her neck, jaw, and ear. Every day she was going through it. She would take Tylenol for it, but it was not helping much. She doesn't have the NDC/lot/expiration for the Tylenol. She also tried Motrin. To try to figure out which would work best. She went to the Emergency room because she was nervous it could be her heart. They said she was having a muscle spasm and an acid reflux attack. She has a history of GERD and throat reflux. She just hasn't been on medication for it. Since she was boosted and everything. She took Tylenol and Pepcid AC. She just takes it here and there. It was necessary. She definitely took it when she was in pain. She is on medication for that thrush too now. The day she was diagnosed on a rapid was on Tuesday, and she saw her doctor then. She had to get a doctor's note saying she was positive for COVID so she could get COVID pay. prior Vaccinations (within 4 weeks): not provided. Patient's Medical History (including any illness at time of vaccination): Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: no. Relevant Tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI): no. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizziness; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, unknown manufacturer), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown".  The lot number for the vaccine BNT162b2 (COMIRNATY), was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2020 as dose 1, single (Lot number: EK9231), in left arm, on 17Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 21Dec2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 59 years, in left arm for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "SULFA allergy" (unspecified if ongoing). Concomitant medication(s) included: COZAAR; ZYDUS; VITAMIN D 2000; ACETAMINOPHEN; FOLIC ACID; B-12; ESTROVEN; TURMERIC CURCUMIN.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid (lot number: FY9928) from 11May2022 to 16May2022. Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient was taking as concomitant therapy.; Sender's Comments: Based on the information available , a possible contributory role of the suspect  BNT162b2 cannot be excluded for the reported events of covid-19 and vaccination failure.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: deafness in one ear/ hearing loss; Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient. Other Case identifier(s): 2022SA142853 (Sanofi).  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; insulin glargine, lixisenatide (SOLIQUA), since 2020 (Lot number: 1F467A, Expiration Date: 30Jun2023) at 15 iU 1x/day for type 2 diabetes mellitus; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing), notes: Elasomeran (Moderna covid-19 vaccine) and Tozinameran (Pfizer BioNTech Covid-19 Vaccine). The patient's concomitant medications were not reported.  The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "deafness in one ear/ hearing loss"; TINNITUS (non-serious), outcome "unknown". The action taken for insulin glargine, lixisenatide was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Oct2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left 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), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment: Paxlovid. Treatment start date: 05May2022 and stop date: 09May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse) from Regulatory Authority. The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Feb2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Sep2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01May2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 20Apr2022, stop date: 04May2022. The following information was reported: COVID-19 (medically significant) with onset 15May2022 at 08:00, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 15May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Negative; (15May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course- After feeling fully recovered and testing negative on 12May2022, The patient developed headache, runny nose, sore throat, fatigue and tested positive on rapid anti-gen test 15May2022. The patient did not have any Known allergies. The 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: Suspected COVID-19, 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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 at 12:00 as dose 1, single (Lot number: EL9264), in right arm, on 19Feb2021 at 12:00 as dose 2, single (Lot number: EL9266), in right arm and on 13Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3181) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies:Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Additional information: If vaccine received Yes. other medication in 2weeks No. anti viral details: product: COVID 19 Treatment, brand: pfizer, treatment start date: 02May2022, treatment stop date: 07May2022, lot number: unknown, indication: Treatment of COVID-19. Did you/the patient previously receive a COVID-19 Vaccine reported as yes.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
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 42-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: fg3527) at the age of 42 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: "depression and anxiety" (unspecified if ongoing); "depression and anxiety" (unspecified if ongoing); "mild bradycardia" (unspecified if ongoing), notes: mild bradycardia. Concomitant medication(s) included: LEXAPRO.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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: (05May2022) Positive; (May2022) Negative, notes: nearly negative for a few days; (16May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Other medication in 2 weeks was reported as yes. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as yes. Did you/the patient previously receive a COVID-19 Vaccine was reported as yes. If treatment AE was reported as no. No known allergies reported.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Magnetic resonance imaging, Suspected COVID-19, Weight
Clinical narrative: on 21Aug2021, the patient experienced LINGERING COVID ISSUES; on 21Aug2021, the patient experienced LINGERING COVID ISSUES; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4388298-00 (Agency).  A 49-year-old female patient received BNT162b2 (BNT162B2), on 03Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as citrate free (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 21Aug2021, outcome "unknown" and all described as "on 21Aug2021, the patient experienced LINGERING COVID ISSUES". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Spots on her brain, notes: Spots on her brain; Weight: Sixty pound weight loss, notes: Sixty pound weight loss. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "on 21aug2021, the patient experienced lingering covid issues" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality:  Drug: HUMIRA (Solution for injection in pre-filled pen) (ADALIMUMAB)   COVID-19  (COVID-19)   Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported  De challenge: N/A  Seq.No. 2 Drug: PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) )(TOZINAMERAN)Unknown, Un-known, Unknown  Causality: .COVID-19  (COVID-19)   Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Possible Dechallenge: N/A   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available possible contributory role of the suspect  BNT162b2   cannot be excluded for the reported events of drug ineffective,covid-19.
Sex: F
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Nov2021 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) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure and mild asthma" (unspecified if ongoing); "mild asthma" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE. 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: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.