chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gait disturbance, Guillain-Barre syndrome, Inflammation, Insomnia
Clinical narrative: Muscle aches/Body aches; Minor side effect; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Minor side effect) and MYALGIA (Muscle aches/Body aches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 0021321A) for COVID-19 prophylaxis.     The patient's past medical history included Ulcer NOS (past medical history of ulcers, so patient could not take any NSAIDS and could only take Tylenol). Concurrent medical conditions included Fibromyalgia (Diagnosed about 15 years ago).   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced MYALGIA (Muscle aches/Body aches). In 2021, the patient experienced IMMUNISATION REACTION (Minor side effect). At the time of the report, IMMUNISATION REACTION (Minor side effect) and MYALGIA (Muscle aches/Body aches) outcome was unknown.            The patient was used to the body aches and achiness as the patient had a medical history of fibromyalgia.  No concomitant medications were reported.  The patient had the same minor side effect after the first two shots of Moderna vaccine. The patient had no leg weakness after the first two shots of Moderna vaccine.  About 7 or 8 hours later after vaccination with the two shots, the patient had some body aches and muscle aches.  No treatment medications were reported.   This case was linked to MOD-2022-637940 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Musculoskeletal discomfort, Myalgia, Pain
Clinical narrative: Muscle aches/Body aches; Minor side effect; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Minor side effect) and MYALGIA (Muscle aches/Body aches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 0021321A) for COVID-19 prophylaxis.     The patient's past medical history included Ulcer NOS (past medical history of ulcers, so patient could not take any NSAIDS and could only take Tylenol). Concurrent medical conditions included Fibromyalgia (Diagnosed about 15 years ago).   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced MYALGIA (Muscle aches/Body aches). In 2021, the patient experienced IMMUNISATION REACTION (Minor side effect). At the time of the report, IMMUNISATION REACTION (Minor side effect) and MYALGIA (Muscle aches/Body aches) outcome was unknown.            The patient was used to the body aches and achiness as the patient had a medical history of fibromyalgia.  No concomitant medications were reported.  The patient had the same minor side effect after the first two shots of Moderna vaccine. The patient had no leg weakness after the first two shots of Moderna vaccine.  About 7 or 8 hours later after vaccination with the two shots, the patient had some body aches and muscle aches.  No treatment medications were reported.   This case was linked to MOD-2022-637940 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Fatigue, Pain in extremity
Clinical narrative: Upset stomach; FATIGUE; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), FATIGUE (FATIGUE) and PAIN IN EXTREMITY (Sore arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis, Plaque psoriasis and Ulcerative colitis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe ), Plaque psoriasis (MODERATE TO SEVERE CHRONIC ) and Ulcerative colitis (MODERATE TO SEVERE ).   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), FATIGUE (FATIGUE) and PAIN IN EXTREMITY (Sore arm). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), FATIGUE (FATIGUE) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medication were provided  There was no reported medical history.    It was reported that the patient had covid vaccination issue. It was reported that Rinvoq upsets patient's stomach, but this was alleviated by taking it at night. Patient was using Rinvoq for moderate to severe chronic plaque.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality of Rinvoq for the events upset stomach, fatigue and sore arm was not provided.  No treatment details were provided.
Sex: M
Vaccine: COVID19
Symptoms: Accident at home, Balance disorder, Dizziness, Fall
Clinical narrative: He fell over on his own house; He fell over on his own house and was injured; Balance issues; Always felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FALL (He fell over on his own house), ACCIDENT AT HOME (He fell over on his own house and was injured), BALANCE DISORDER (Balance issues) and DIZZINESS (Always felt dizzy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (He fell over on his own house), ACCIDENT AT HOME (He fell over on his own house and was injured), BALANCE DISORDER (Balance issues) and DIZZINESS (Always felt dizzy). At the time of the report, FALL (He fell over on his own house), ACCIDENT AT HOME (He fell over on his own house and was injured) and BALANCE DISORDER (Balance issues) outcome was unknown and DIZZINESS (Always felt dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; tested positive again; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "breast cancer", start date: 2018 (unspecified if ongoing), notes: breast cancer 4 years ago (no current treatment). Concomitant medication(s) included: OMEPRAZOLE; FAMOTIDINE. Past drug history included: Known allergies: codeine, reaction(s): "known allergies: Codeine". The following information was reported: DISEASE RECURRENCE (medically significant) with onset 27Aug2022, outcome "not recovered", described as "tested positive again"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication: Covid-19 treatment; (25Aug2022) Negative, notes: testing negative for two days; (26Aug2022) Negative, notes: testing negative for two days; (27Aug2022) Positive, notes: tested positive again for two days; (28Aug2022) Positive, notes: tested positive again for two days. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: Product for COVID 19 treatment, treatment start date 20Aug2022, treatment stop date is 24Aug2022 Indication for treatment of COVID-19. Experienced relapse and re-emergence of symptoms on the 4th day after finishing Paxlovid; tested positive again for two days after testing negative for two days. Adverse event start date: 28Aug2022.adverse event start time is 02:00 AM, no treatment for adverse event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EK5730), on 12Jan2021 as dose 2, single (Lot number: EL1284) and on 29Sep2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "history of asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa and erythromycin. Concomitant medication(s) included: YAZ. Past drug history included: Known allergy: erythromycin, reaction(s): "allergy", notes: Known allergies: sulfa and erythromycin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2022) Negative, notes: On 19Aug2022 I tested negative for the first time after having covid; (20Aug2022) Positive, notes: On Saturday 20Aug2022 I developed a mild sore throat again and tested faintly positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 70.0
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) (Physician).  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown), on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hormone replacement therapy" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: Patient has no Known allergies. Anti viral details: Product: COVID 19 treatment  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 reasonable possibility of causal association between the events vaccination failure and COVID 19 and suspect vaccine BNT162B2.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient felt better by 25Aug2022; however on 28Aug2022, Covid symptoms returned (Rebound; had Covid symptoms beginning 18Aug2022. Had Rapid Antigen Test 19Aug2022. Tested Positive and PCP; had Covid symptoms beginning August 18, 2022. Had Rapid Antigen Test August 19, 2022. Tested Positive and PCP; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EN5318), in left arm, on 19Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 26Oct2021 as dose 3 (booster), single (Lot number: FU8020), in left arm and on 29Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing), notes: Other medical history: HBP.; "Enlarged Prostate" (unspecified if ongoing); "Gastritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ultram, reaction(s): "Known allergies: Ultram", notes: Known allergies: Ultram. The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Aug2022, outcome "recovering", described as "had Covid symptoms beginning 18Aug2022. Had Rapid Antigen Test 19Aug2022. Tested Positive and PCP"; COVID-19 (medically significant) with onset 19Aug2022, outcome "recovering", described as "had Covid symptoms beginning August 18, 2022. Had Rapid Antigen Test August 19, 2022. Tested Positive and PCP"; DISEASE RECURRENCE (medically significant) with onset 28Aug2022, outcome "unknown", described as "Patient felt better by 25Aug2022; however on 28Aug2022, Covid symptoms returned (Rebound". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Aug2022) Positive, notes: Had Rapid Antigen Test August 19, 2022. Tested Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; I tested negative on Day 8, and just re-tested positive again on Day 14.; 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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: EW6202), on 19Apr2021 as dose 2, single (Lot number: EW0151) and on 26Oct2021 at 15:45 as dose 3 (booster), single (Lot number: FH8020) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing), notes: Mild asthma; "history of chronic bronchitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "recovering", described as "I tested negative on Day 8, and just re-tested positive again on Day 14."; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: I tested negative on Day 8; (Aug2022) Positive, notes: just re-tested positive again on Day 14. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient took antiviral product Paxlovid for covid-19 treatment starting from 17Aug2022 till 22Aug2022. She was prescribed and took Paxlovid for COVID-19 on Day 1, one day after original symptoms onset. She tested negative on Day 8, and just re-tested positive again on Day 14. Symptoms have improved slowly but persisted since original onset. For Other medication in 2 weeks product was Tylenol/Advil with start date 16Aug2022, stop date was 30Aug2022.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 74-year-old male patient received BNT162b2 (BNT162B2), on 04Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLOMAX [MORNIFLUMATE], stop date: 21Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2 weeks: Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: I contracted Covid-19; I contracted Covid-19; I was very, very ill and kind of; kind of bedridden; 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 49-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Lot number: EL3247), in arm, as dose 2, single (Lot number: EL3247), in arm and as dose 3 (booster), single (Batch/Lot number: unknown), in 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 "recovering" and all described as "I contracted Covid-19"; ILLNESS (non-serious), outcome "recovering", described as "I was very, very ill and kind of"; BEDRIDDEN (non-serious), outcome "recovering", described as "kind of bedridden". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I tested positive on Sunday. Therapeutic measures were taken as a result of drug ineffective, covid-19, illness, bedridden.  Clinical course: Consumer stated, he contracted Covid-19, he tested positive on Sunday and he just reported, he was very, very ill and kind of bedridden so he was reporting now when he was well enough to call, so Sunday when he tested positive. Treatment for adverse event was just Tylenol.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: 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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28May2022 at 09:00 as dose 4 (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 14Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Jan2022 as dose 3 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; COVID 19 Treatment included Paxlovid from 19Aug2022 to 22Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID 31Aug2022; Tested positive for COVID 31Aug2022; Dose Number: 1: Moderna/Dose Number: 2: Moderna/Dose Number: 3: Pfizer; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Jan2021 as dose 1, single (Lot number: 012L2UA), in left arm and on 11Feb2021 as dose 2, single (Lot number: 031L20VT), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEVOXYL. Past drug history included: Known allergies:daypro, reaction(s): "allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Dec2021, outcome "unknown", described as "Dose Number: 1: Moderna/Dose Number: 2: Moderna/Dose Number: 3: Pfizer"; DRUG INEFFECTIVE (medically significant) with onset 31Aug2022, outcome "not recovered", COVID-19 (medically significant) with onset 31Aug2022, outcome "not recovered" and all described as "Tested positive for COVID 31Aug2022". The event "tested positive for covid 31aug2022" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Aug2022) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19..  Clinical course: Patient did not have vaccine in four weeks. Adverse event resulted in [Doctor or other healthcare professional office/clinic visit]. Patient had no covid prior vaccination. Covid tested positive post vaccination. Covid test type post vaccination: Nasal Swab on 31Aug2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective  and Covid-19 and  interchange of vaccine product  the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a 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 22Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6203), in right arm and on 01Nov2021 as dose 3 (booster), single (Lot number: FN8028) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Previous history of Asthma. Concomitant medication(s) included: ADVIL [IBUPROFEN], start date: 19Aug2022, stop date: 25Aug2022; FLONASE ALLERGY RELIEF, start date: 15Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Finished Paxlovid 25Aug. Developed "rebound symptoms" including flushed face, fatigue, muscle aches on 30Aug; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 74-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years 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: "dyslipidemia" (unspecified if ongoing); "thrombocytopenia" (unspecified if ongoing); "HTN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Fentanyl, reaction(s): "Known allergies: Fentanyl"; Keflex, reaction(s): "Known allergies: Keflex"; Omeprazole, reaction(s): "Known allergies: Omeprazole"; Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "recovering", described as "Finished Paxlovid 25Aug. Developed "rebound symptoms" including flushed face, fatigue, muscle aches on 30Aug"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering", and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: It was reported that patient received COVID 19 Treatment with Paxlovid from 21Aug2022 to 25Aug2022. Finished Paxlovid 25Aug2022. Developed "rebound symptoms" including flushed face, fatigue, muscle aches on 30Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Sep2020 at 12:00 as dose 1, single (Lot number: P220395) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:Patient received anti-viral treatment Paxlovid (Brand: Pfizer) from 15Aug2022 to 20Aug2022.
Sex: M
Vaccine: COVID19
Symptoms: Henoch-Schonlein purpura
Clinical narrative: Developed Henoch-Schonlein Purpura  as a direct result of the second Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the parent.  A 5-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "rheumatoid arthritis" (unspecified if ongoing), notes: Early onset of rheumatoid arthritis. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HENOCH-SCHONLEIN PURPURA (hospitalization) with onset Apr2022, outcome "not recovered", described as "Developed Henoch-Schonlein Purpura  as a direct result of the second Covid vaccine". The event "developed henoch-schonlein purpura  as a direct result of the second covid vaccine" required emergency room visit.   Clinical course: Dates when patient was in hospital for Developed Henoch-Schonlein Purpura  as a direct result of the second Covid vaccine was reported as unknown. Other conditions were reported as yes; investigation was not provided. Reporter confirmed she (Reporter) was calling about the Pfizer Covid vaccine and confirmed her son (patient) developed HSP, as a direct result of the second Covid vaccine. Clarified HSP as: Henoch-Schonlein Purpura. Caller states the (Redacted) clinic, there was a team of doctors, with multiple specialties. Reporter Stated her son Developed Henoch-Schonlein Purpura  as a direct result of the second Covid vaccine and her son was in the emergency room twice, and hospitalized as an in patient 3 times. Happened 11 weeks after his Covid vaccine. Caller stated she does not have her sons vaccine card readily available at this time and did not had information about the first dose. Reporter (Patient's mother) enquired why were they taking that report and asked if Pfizer compensating people who take the vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
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 72-year-old patient received BNT162b2 (BNT162B2), on 05Aug2022 as dose 4 (booster), single (Lot number: FP7139) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE; VITAMIN D [VITAMIN D NOS].  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took other medication in 2weeks. The patient had No Known allergies.
Age: 61.0
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 61-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 14Apr2021 at 10:00 as dose 2, single (Lot number: EW0169), in left arm, on 01Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 11Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Central Sensitization" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (29Aug2022) Negative, notes: Roche home antigen test resulted negative 29Aug2022; (31Aug2022) Positive, notes: Roche home antigen test resulted positive on 31Aug2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient was treated with PAXLOVID for COVID 19 Treatment from 23Aug2022 to 27Aug2022 (lot number: GA6765). Rebound symptoms on 30Aug2022 16:00 also reported as [day 2 (31Aug2022)] after stopping Paxlovid. Roche home antigen test resulted negative 29Aug2022. Roche home antigen test resulted positive on 31Aug2022.
Sex: M
Vaccine: TBE
Symptoms: Lyme disease
Clinical narrative: Lyme disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received tick-borne encephalitis vaccine (TICOVAC), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYME DISEASE (medically significant), outcome "unknown".  Clinical course included as patient stated that he is trying to find a location to be able to receive the Ticovac vaccine before he visited another country. Mentioned that they highly recommend it over there and since he spend a lot of time in the woods there and got Lyme disease previously, it is important to him to receive it.  The information on the batch/lot number for tick-borne encephalitis vaccine has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller stated having the COVID-19 Primary Series Vaccination with Pfizer and 1 Pfizer booster. She had COVID-19 at the end of Jul; Caller stated having the COVID-19 Primary Series Vaccination with Pfizer and 1 Pfizer booster. She had COVID-19 at the end of Jul; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 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) all with onset Jul2022, outcome "recovered" (2022) and all described as "Caller stated having the COVID-19 Primary Series Vaccination with Pfizer and 1 Pfizer booster. She had COVID-19 at the end of Jul". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: She had COVID-19 at the end of Jul2022 during one week and then tested negative again; (Jul2022) Positive, notes: She had COVID-19 at the end of Jul2022 during one week and then tested negative again. The patient stated she had the COVID-19 Primary Series Vaccination with Pfizer and 1 Pfizer booster. She had COVID-19 at the end of Jul2022 during one week and then tested negative again. She  had her second booster dated for 03Sep2022 and wanted to know if she should wait for the Omicron specific vaccine to be available. The reporter mentioned her need to know about the specific booster to get was regarding a travel. She and her husband had programmed for Oct (as reported). The patient also wanted to know if she should get COVID-19 antibody testing to know if she was protected, since her HCP told her she could get the regular Pfizer COVID-19 booster. The patient wanted to know if she should get the "normal" Pfizer COVID-19 Vaccine booster or wait for the Omicron specific vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: experiencing tingling in the hands, feet and arms/experiencing tingling in the lower part of her legs as well; itchiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 21Aug2022 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "experiencing tingling in the hands, feet and arms/experiencing tingling in the lower part of her legs as well"; PRURITUS (non-serious), outcome "unknown", described as "itchiness".  Additional information: Documenting possible duplicate AE (DOB withheld, Female) Decline to complete a report with safety. Caller had the adult vaccine second dose and is experiencing tingling in the hands, feet and arms. She wants to know if this is a side effect from the vaccine and if it is normal. Caller she mentioned experiencing tingling in the lower part of her legs as well. She also experiences itchiness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest hurts/Complained of intermittent left chest pain with exertion x 2 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7-year-old male patient received BNT162b2 (BNT162B2), on 03Aug2022 as dose 1, single (Batch/Lot number: unknown) at the age of 7 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID 19" (unspecified if ongoing). There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 20Aug2022, outcome "recovered" (22Aug2022), described as "chest hurts/Complained of intermittent left chest pain with exertion x 2 days". Therapeutic measures were not taken as a result of chest pain.Additional information: Patient didn't receive any other medications in two weeks and other vaccine in four weeks. Patient had no known allergies. Other medical history was none. Patient Grandma reported that, 16 days after vaccination child was running and playing in the yard when he stopped, grabbed at left chest and stated "Grandma my chest hurts". Sat down and rested. Got up to play again and started running around, stopped and went to grandma and said "Grandma my chest hurts". Rested, pain resolved. When I picked him up (I'm mom) that evening I was told the above. Out of character for child to c/o chest pain. No significant previous health history. Grandma did not even know child had been vaccinated. Child wouldn't have known that's a potential adverse reaction Complained of intermittent left chest pain with exertion x 2 days. Symptoms fully resolved on their own after 2 days. Did not see health provider during those 2 days. Recently did have well child visit and physical exam was WNL Timing is a bit extended as compared to published data on chest complaints, however, wanted to report in case it was related to COVID vaccine. Patient didn't tested COVID post vaccination. This case was reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Clarified and confirmed that patient received 4 total doses of the Pfizer COVID-19 vaccine/Received 4 total doses of the vaccine and then got COVID; Clarified and confirmed that patient received 4 total doses of the Pfizer COVID-19 vaccine/Received 4 total doses of the vaccine and then got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "Clarified and confirmed that patient received 4 total doses of the Pfizer COVID-19 vaccine/Received 4 total doses of the vaccine and then got COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller stated she filled out a safety report. The consumer (Patient's mother) reported for a female patient (daughter). Caller was calling about Paxlovid. Patient was a young adult. Caller needed an explanation, caller and patient were concerned about patient's condition. Patient got all of the shots, patient was fully vaccinated. Clarified and confirmed that patient received 4 total doses of the Pfizer COVID-19 vaccine. Caller's daughter, the patient, lived in another state and patient got COVID and was prescribed Paxlovid and took the medication. But once the patient finished taking the medication the patient began getting very thirsty and excessively thirsty. Patient was always thirsty. Patient was going to the doctor tomorrow. Patient had been excessively thirsty for 2 weeks, was constantly having to drink something and had dry mouth. Caller and patient didn't knew the medication wasn't FDA approved. Caller was calling to report that and get information from Pfizer to see whether Pfizer was getting calls in regards to patients getting very thirsty. Caller had asked around to friends and family who had taken the medication. Declined to provide additional reporter details or complete a report, requested to get transferred a site for caller's question. Is there a product complaint to report? Yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Nurse reported a 2-year-old patients developed appendicitis 1 week after receiving vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 2-year-old 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: APPENDICITIS (hospitalization, medically significant), outcome "unknown", described as "Nurse reported a 2-year-old patients developed appendicitis 1 week after receiving vaccine". It was unknown if therapeutic measures were taken as a result of appendicitis.  Additional information: It was unknown whether the patient received other vaccine in four weeks, unknown if received treatment for adverse event, unknown if patient had covid prior vaccination and unknown if tested for covid post vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event appendicitis  with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202201110824 same reporter/product/AE, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Nurse reported a 2nd 2-yearr-old patient developed appendicitis 1 week after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 2-year-old patient received BNT162b2 (BNT162B2), as dose 1 (maroon cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if the patient had other vaccine in four weeks after vaccination. It was unknown if the patient had Covid prior to vaccination. The following information was reported: APPENDICITIS (hospitalization, medically significant), outcome "unknown", described as "Nurse reported a 2nd 2-yearr-old patient developed appendicitis 1 week after receiving the vaccine". It was unknown if therapeutic measures were taken as a result of appendicitis. It was unknown if the patient was tested for Covid-19 post vaccination.  The lot number for [BNT162b2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event appendicitis with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202201110817 same reporter/product/AE, different patient;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AZITHROMYCIN, start date: 31Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated COVID 19 Treatment (Paxlovid) on 31Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.