chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: pcr tested positive; pcr tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 05Apr2021 as dose 2, single (Lot number: EW0150), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type IV Vascular EDS" (unspecified if ongoing); "Vissers-Bodmer syndrome." (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]; ROBITUSSIN 12 HOUR COUGH RELIEF; CALCIUM; OMEGA 3 SELECT; MELATONIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "pcr tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) positive; (09Jun2022) Negative; (15Jun2022) positive; (11Jun2022) positive; (unspecified date) Unknown results; (unspecified date) Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was tested positive for pcr on 06Jun and started Paxlovid that evening. She started pcr testing negative again on 09Jun and confirmed pcr test negative on 10Jun. She finished the Paxlovid course on the morning of 11Jun and pcr tested positive again on 15Jun. Had no symptoms but was scheduled to travel so she decided to test herself again just in case. She confirmed the positive test with two PCR tests and two antigen tests. She had not tested the two days prior so don't know if would have tested positive the two days prior or not. The patient did receive other medication in 2 weeks. The patient was treated with paxlovid from 06Jun2022 to 11Jun2022 for covid-19. The patient's other medications in 2 weeks included daily vitamin. The patient had no known allergies.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 at 16:00 as dose 1, single (Lot number: EK9231), on 20Jan2021 at 14:30 as dose 2, single (Lot number: EL3249), in left arm, on 11Oct2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 14Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FU98-94) at the age of 65 years, in left arm 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, ampucilkin; "Osteoarthritis" (unspecified if ongoing); "Known allergies: ampucilkin" (unspecified if ongoing), notes: Known allergies: Penicillin, ampucilkin. Concomitant medication(s) included: ADVAIR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Medication Advair diskus 100/50 were in 2 weeks after vaccine. received 3rd does on 11Oct2021 at 12:00 AM. Paxlovid started on 31May2022 and stopped on 05Jun2022 for treatment of COVID-19. On 13Jun2022 at 12:00PM, she had recurrent nasal symptoms, cough, fatigue for which no treatment was given and event were recovering.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), on 17Jun2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Jul2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 14Jan2022 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 20May2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown), 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), outcome "unknown", 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: (unspecified date) Unknown results, notes: Treatment of COVID-19; (13Jun2022) Positive; (15Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid (lot number: GA8851) from 07Jun2022 to 12Jun2022. Clinical course: Patient did not received any other medication in 2weeks. Patient still had mild symptoms and still tested positive (both PCR test on Monday at government site on 13Jun2022 and in-home antigen test on15Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMOTRIGINE; LOSARTAN; CRESTOR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If vaccine received: Yes. Other medication in 2weeks: Yes  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2022 at 11:30 as dose 4, (booster) single (Batch/Lot number: unknown) at the age of 53 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: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Sulfa drugs, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (14Jun2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Unknown; (17May2022) positive, notes: day 1; (20May2022) negative, notes: day 4; (22May2022) negative, notes: day 6; (02Jun2022) positive; (14Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2weeks. Took Paxlovid day 1, 17May of  positive COVID test, day 4 and day 6 tested negative and felt 100 percentage better. On 31May2022 at 12:00 PM, event started. Tested again (for work) 02Jun2022 (10 days later) and was positive with 'allergy' symptoms returning. Continued to test positive until 14Jun2022. Never had more than mild covid symptoms. She did have nausea while taking Paxlovid.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 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 55-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 24Sep2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 01Apr2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medications in two weeks reported as No. Paxlovid used as COVID 19 treatment started on 02Jun2022 and stopped on 07Jun2022. Patient tested positive with home tests day two through 8 with symptoms including fever and cough, tested negative day 10-12 feeling much better. Symptoms and positive test results days 12-16. New symptoms fever (lower than earlier infection) with severe congestion. Known allergies reported as No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Then symptoms came back again 2 weeks later; Then symptoms came back again 2 weeks later; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single 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 and concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Then symptoms came back again 2 weeks later". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Endoscopy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Drug ineffective; Contracted Covid after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9269), on 01Mar2021 as dose 2, single (Lot number: EN6203) and on 23Aug2021 as dose 3 (booster), single (Lot number: EW0180) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Stomach ulcers" (unspecified if ongoing); "seizure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE taken for gastric ulcer; KEPPRA XR taken for seizure; EZETIMIBE taken for blood cholesterol decreased. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Contracted Covid after vaccination". The patient underwent the following laboratory tests and procedures: Endoscopy: (unspecified date) Unknown results, notes: he didn't see anything in the endoscopy, but there's a lot of stomach area in there; SARS-CoV-2 test: (15May2022) positive, notes: Tested positive for Covid on 15May2022; (23May2022) negative, notes: Tested negative for Covid on 23May2022.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: hasn't been feeling right; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team.  A 50-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "hasn't been feeling right".  Additional information: The caller was asking for information on behalf of the doctor. She would like to know a few things that could be helpful for their patients. She had a patient that came yesterday on 15Jun2022 after being vaccinated and began experiencing symptoms and side effects. She wanted to know if there are any designated facilities that could help them with their symptoms. It was reported that the caller wanted information on facilities that could help patients that had the Comirnaty vaccine. withheld states the patient started having symptoms yesterday since they got the vaccine, but the caller doesn't know the specific symptoms. Confirmed reporter details and clarified the above information with the caller. Email: Declines, PCP: Caller states the PCP will refer the call to her. Caller clarifies it was not yesterday, the patient has had the vaccine for months now and hasn't been feeling right. Doesn't know when had it done. Clarifies she doesn't know what the patient's symptoms are.  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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID/First positive test was 06Jun; COVID/First positive test was 06Jun; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1,single (Lot number: EN6198), on 02Apr2021 as dose 2, single (Lot number: ER8732) and on 19Oct2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "asthma" (unspecified if ongoing); "migraine headache" (unspecified if ongoing); "peanuts" (unspecified if ongoing); "mangoes" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 01Jan2022, stop date: 16Jun2022; SPIRONOLACTONE, start date: 01Jan2022, stop date: 16Jun2022; TOPAMAX, start date: 01Jan2022, stop date: 16Jun2022; MELATONIN, start date: 01Jan2022, stop date: 16Jun2022; SUMATRIPTAN, start date: 08Jun2022, stop date: 10Jun2022; ALBUTEROL [SALBUTAMOL], start date: 06Jun2022, stop date: 08Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "not recovered" and all described as "COVID/First positive test was 06Jun". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Positive, notes: First positive test was 06Jun; (14Jun2022) Negative, notes: Tested negative 14Jun; (16Jun2022) Positive, notes: Tested positive again 16Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Information:No other medication were received in 2weeks. Anti viral details.Product: COVID 19 Treatment, brand: Paxlovid.Treatment start date 06Jun2022,Treatment end date 10Jun2022.Indication:Treatment of COVID-19.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Batch/Lot number: unknown), on 16Feb2021 as dose 2, single (Batch/Lot number: unknown), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREMPRO. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment".  Clinical course: The patient took other medication Apprise within two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Lot number: fk9394), 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: "Diabetes mellitus" (unspecified if ongoing). 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Positive, notes: Positive Covid test results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: The patient received vaccine. Adverse event included Covid symptoms recur on 15Jun and positive covid test results. Other medication in 2 weeks were not reported. Anti-viral product included Paxlovid for Covid-19 treatment started from 03Jun2022 till 08Jun2022. The patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Tested positive for Covid-19. Symptoms are like cold. Fatigue. Slight fever.; Tested positive for Covid-19. Symptoms are like cold. Fatigue. Slight fever.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: 32030BD), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 74 years, in right arm for Covid-19 immunization; 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 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccine in four weeks. No Other medications were received in two weeks of Covid vaccine. The patient was not diagnosed with Covid prior vaccination.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 15Jun2022 at 20:30, outcome "unknown", COVID-19 (medically significant) with onset 15Jun2022 at 20:30, outcome "recovering" and all described as "Tested positive for Covid-19. Symptoms are like cold. Fatigue. Slight fever.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (15Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "High blood sugar" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: corn" (unspecified if ongoing); "Known allergies: milk" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Empirin, reaction(s): "Known allergies: empirin". The following information was reported: DRUG INEFFECTIVE (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: Blood glucose: (unspecified date) High; SARS-CoV-2 test: (08Jun2022) Negative; (11Jun2022) Positive; (15Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 01Jun2022 and stopped on 06Jun2022. Clinical course reported as, two days after testing negative on 08Jun2022, she started sneezing again on 10Jun2022. She took a Covid rapid test on 11Jun2022 and it was positive. Her symptoms had returned, sneezing, runny nose, tightness in the chest as well as a mostly dry cough that gets worse at night. Yesterday 15Jun2022, she was still testing positive and coughing, especially at night as well as some daytime coughing. Patient received no treatment for symptoms and not recovered from symptoms. Also patient received Tylenol (reported as other medication in two weeks) started on 01Jun2022 and stopped on 01Jun2022 (Lot number: SSC214) for unknown indication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dental discomfort, Drug ineffective, Pyrexia, Suspected COVID-19, Taste disorder
Clinical narrative: diagnosed with Covid; diagnosed with Covid; dental issue; my mouth tastes funny; I have a low fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. An 80-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 18Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 79 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with Covid"; DENTAL DISCOMFORT (non-serious), outcome "unknown", described as "dental issue"; TASTE DISORDER (non-serious), outcome "unknown", described as "my mouth tastes funny"; PYREXIA (non-serious), outcome "unknown", described as "I have a low fever". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19, dental discomfort, taste disorder. Patient was diagnosed with Covid, asking about Paxlovid he was prescribed it, but also taking amoxicillin for dental issue. First dose of Paxlovid taken last night took the evening dose of Paxlovid. Patient states, his mouth tastes funny, he was also taking gluconate mouthwash also, and amoxicillin. Patient also had a low fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EN9582), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 12Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 14Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Elevated cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 01Jan2022, stop date: 02Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) positive, notes: Tested positive on 03Jun; (16Jun2022) positive, notes: I retested positive for Covid 19 on 16Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Recurrence of Covid 19 symptoms 12 days after original symptoms appeared. Tested positive on 03Jun2022, began Paxlovid on the evening of 04Jun2022. The patient took the last dose of Paxlovid the morning of 09Jun2022 and he was symptom free for 4 days. Symptoms returned on the evening of 13Jun. He retested positive for Covid 19 on 16Jun2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "unspecified autoimmune disease, asthma" (unspecified if ongoing), notes: unspecified autoimmune disease, asthma; "unspecified autoimmune disease, asthma" (unspecified if ongoing), notes: unspecified autoimmune disease, asthma. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant),SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as  COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
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) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 as dose number unknown, single (Lot number: 30135BA) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "hashimoto thyroiditis(hypothyroid)" (unspecified if ongoing); "Allergy: Mushrooms" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEVOTHYROXINE. 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: anti viral details  Paxlovid, treatment start date: 02Jun2022,treatment stop date: 04Jun2022, indication: Treatment of COVID-19
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, 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) from product quality group.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 72 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: "CAD" (unspecified if ongoing); "prostate cancer", start date: 2014 (unspecified if ongoing), notes: prostate cancer s/p treatment and cure (2014); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Feb2019; FEXOFENADINE, start date: Feb2019; SERTRALINE, start date: Oct2018; TERBINAFINE, start date: Oct2021. Past drug history included: Chlorhexidine, reaction(s): "Known allergies: Chlorhexidine".  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: Blood cholesterol: High; SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 05Jun2022 to10Jun2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: sore arm at injection site; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5-year-old male patient received BNT162b2 (BNT162B2), on 14Jun2022 as dose 3 (booster), single (Lot number: FL8094) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FK5618), administration date: 23Dec2021, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: FK5618), administration date: 13Jan2022, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 15Jun2022, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 15Jun2022, outcome "unknown", described as "sore arm at injection site". Therapeutic measures were not taken as a result of vaccination site pain, nausea.  Additional information: The patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination. Query: The Pfizer Drug safety unit recently received the attached report submitted by you via pfizersafetyreporting.com. It is unclear whether or not you had first-hand knowledge of the events reported. Please help to confirm if you were in direct contact with the person who reported these events to you. If you were not directly in contact with the reporter, kindly provide the reporter's contact information. Please ensure to reply all to this email. Response: Yes, I was in direct contact with the person reporting these events to me.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Partial seizures, Temporal lobe epilepsy
Clinical narrative: Temporal lobe epilepsy; I developed focal seizures; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: High BP; "high cholesterol" (unspecified if ongoing), notes: high cholesterol; "hemochromatosis" (unspecified if ongoing), notes: hemochromatosis; "prediabetic" (unspecified if ongoing), notes: pre-diabetic. The patient's concomitant medications were not reported. Past drug history included: Known allergies: lisinopril, reaction(s): "Drug allergy", notes: Known allergies: Lisinopril. Vaccination history included: BNT162b2 (Dose 1, Lot no:  Er8733, Administration time: 13:00, Vaccine location:Left arm), administration date: 28Mar2021, when the patient was 36-year-old, for Covid-19 immunization. The following information was reported: PARTIAL SEIZURES (medically significant) with onset 01Mar2022, outcome "not recovered", described as "I developed focal seizures"; TEMPORAL LOBE EPILEPSY (medically significant) with onset 01Mar2022, outcome "not recovered". The events "temporal lobe epilepsy" and "i developed focal seizures" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of temporal lobe epilepsy, partial seizures. Clinical course: Facility type vaccine: Public Health Clinic/ Administration facility. No other vaccine in four weeks.  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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event PARTIAL SEIZURES, TEMPORAL LOBE EPILEPSY Cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 23Apr2021 as dose 2, single (Lot number: ER8796), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN, start date: 01Sep2021; VERAPAMIL, start date: 15Mar2022; ATORVASTATIN, start date: 01Jan2018. 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: Unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: vaccine was received and patient received other medication in 2weeks.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Skin discolouration, Vitiligo
Clinical narrative: white patches on her skin on sides, folds of legs and near anus; vitiligo; This is a spontaneous report received from contactable reporter(s) from medical information team.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 27May2022 as dose 1, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 10Jun2022, outcome "not recovered", described as "white patches on her skin on sides, folds of legs and near anus"; VITILIGO (non-serious) with onset 2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated her daughter was giving her granddaughter a bath noticed large white patches on the patient's sides, around folds of her leg and near her anus, states they are extremely pronounced white patches. Reporter stated her granddaughters has naturally dark skin. The preliminary diagnosis from the pediatrician is vitiligo. Reporter states they have been doing research and have come across two hits that showed cases of hyperpigmentation problems after the vaccines, so she sent the doctor those articles. The patient had blood work drawn and they were waiting on the results of these. Reporter stated her daughter would have more information as she was patient's mother and able to get a hold of her at any time. It was unknown where the patient got the vaccine, probably at her pediatrician's office but she is unsure. Reporter read that there is an ultraviolet light therapy that if caught soon can really help with treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Lot number: 010A21A), in left arm and on 08Apr2021 as dose 2, single (Lot number: 036B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (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 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive, notes: I developed symptoms again and tested positive for Covid two weeks later. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2weeks. She developed symptoms again and tested positive for Covid two weeks later. Patient had no known allergy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling
Clinical narrative: Started to swell and developed a right breast on 6/10. The breast got larger and larger abs began to cause pain.; Started to swell and developed a right breast on 6/10. The breast got larger and larger abs began to cause pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 06Jun2022 as dose 3 (booster), single (Lot number: FM7553) at the age of 16 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0191), administration date: 26Jun2021, when the patient was 15-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0179), administration date: 03Jun2021, when the patient was 15-year-old, for Covid-19 Immunization. The following information was reported: BREAST SWELLING (non-serious), BREAST PAIN (non-serious) all with onset 10Jun2022, outcome "recovering" and all described as "Started to swell and developed a right breast on 6/10. The breast got larger and larger abs began to cause pain.". The events "started to swell and developed a right breast on 6/10. the breast got larger and larger abs began to cause pain." required physician office visit and emergency room visit.  Additional information: Started to swell and developed a right breast on 10Jun. The breast got larger and larger abs began to cause pain. Went to the ER on 12Jun and was referred to an endocrinologist.the patient was not diagnosed with COVID-19 and not been tested for COVID-19, Since the vaccination. No known allergies. the patient did not  receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling
Clinical narrative: Swollen feet; Bottom of feet were purple; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swollen feet"; LIMB DISCOMFORT (non-serious), outcome "recovered", described as "Bottom of feet were purple". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200845773 same reporter/drug, different patients/AE;
Age: 53.0
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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: El1283), in left arm, on 22Feb2021 as dose 2, single (Lot number: En6201), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing), notes: Obese; "sleep apnea" (unspecified if ongoing); "Eustachian tube dysfunction" (unspecified if ongoing), notes: Eustachian tube disfunction; "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish; "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex. Concomitant medication(s) included: CELEBREX, start date: 26Jul2021, stop date: 06Jun2022. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) Negative, notes: Tested COVID negative on 12Jun2022 & 13Jun2022; (13Jun2022) Negative, notes: Tested COVID negative on 12Jun2022 & 13Jun2022; (15Jun2022) positive, notes: COVID symptoms returned on 15Jun2022 & tested positive on 15Jun2022. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Additional information: Tested COVID negative on 12Jun2022 & 13Jun2022 after Paxlovid course ended on 10Jun2022. COVID symptoms returned on 15Jun2022 & tested positive on 15Jun2022. Antiviral product included Paxlovid started on 05Jun2022 for Treatment of COVID-19 and stopped on 10Jun2022. Other medication in 2weeks product details: Celecoxib, Celebrex started on 26Jul2021 and stopped on 06Jun2022, Emergen-C, started on 04Jun2022 and stopped on 10Jun2022, Sambucol, started on 05Jun2022 and stopped on 12Jun2022, Ayurveda Tea Elderberries Echinacea, Herbal Cup Tea started on 05Jun2022 and stopped on 15Jun2022, D3 50 mcg, Nature Made started on 05Jun2022 and stopped on 10Jun2022 (lot number 2434964), Zinc 50 mg, NOW foods started on 05Jun2022 and stopped on 10Jun2022 (lot number 3184716).  No follow-up attempts are possible. No further information is expected.