chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Peripheral swelling
Clinical narrative: Arm was swollen; tired; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen) and FATIGUE (tired) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 037F21A, 011M20A and 028L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm was swollen) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm was swollen) and FATIGUE (tired) had resolved.            Patient had no prior health conditions. No concomitant medication were reported.  Patient was tired and arm was swollen for a couple of days.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: It was given to 2 people beyond the 12 hr mark.; No adverse event; There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.), PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.) and NO ADVERSE EVENT (No adverse event) in a 27-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2022 at 10:15 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Nov-2022 at 10:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.), PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.) and PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.).    No concomitant medications were reported. There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster. It was given to 2 people beyond the 12 hr mark.  Vial size was reported as 2.5 mL On 04-Nov-2022, the vial was initially stored in the refrigerator.  On 08Nov2022, Vial was first punctured.  The vial stored post puncture in Refrigerator.  The vial did not undergo any temperature excursions. Vial was remained refrigerated within range. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-672851 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672851:MOD-2022-672851 (IB patient)
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: had pretty severe side effects after the primary doses; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had pretty severe side effects after the primary doses) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had pretty severe side effects after the primary doses). At the time of the report, IMMUNISATION REACTION (had pretty severe side effects after the primary doses) outcome was unknown.            No concomitant information was reported. No treatment information was provided.   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Patient never received his 2nd dose of Moderna COVID-19 vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient never received his 2nd dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient never received his 2nd dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient never received his 2nd dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient never received his 2nd dose of Moderna COVID-19 vaccine).    No concomitant medications were reported. Patient never received the second dose. Patient has not reported any adverse reactions to the first dose. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received Bivalent Booster as the 2nd Primary dose by mistake; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Bivalent Booster as the 2nd Primary dose by mistake) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Bivalent Booster as the 2nd Primary dose by mistake). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Bivalent Booster as the 2nd Primary dose by mistake) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Bivalent Booster as the 2nd Primary dose by mistake).    Patient age was about 40-year-old.   First Primary monovalent dose was taken on unknown date, Lot and Expiration Date was unknown.   No concomitant medications was reported.  The patient received Bivalent Moderna COVID-19 booster vaccine, instead of the 2nd Primary shot, on 12-NOV-2022. After the shot was administered, the patient informed them that he only had 1 previous  COVID-19 shot.  No treatment medications was reported.   Reporter did not allow further contact
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was first punctured on 14-Nov-2022 03:00 PM and administered on 15-Nov-2022 08:45 AM; No adverse event; Moderna booster dose given to a patient but it was expired / Dose administered more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna booster dose given to a patient but it was expired / Dose administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 14-Nov-2022 03:00 PM and administered on 15-Nov-2022 08:45 AM) and NO ADVERSE EVENT (No adverse event) in a 55-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022 at 8:45 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Nov-2022 at 8:45 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna booster dose given to a patient but it was expired / Dose administered more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 14-Nov-2022 03:00 PM and administered on 15-Nov-2022 08:45 AM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna booster dose given to a patient but it was expired / Dose administered more than 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 14-Nov-2022 03:00 PM and administered on 15-Nov-2022 08:45 AM) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna booster dose given to a patient but it was expired / Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 14-Nov-2022 03:00 PM and administered on 15-Nov-2022 08:45 AM).    Concomitant medication was not provided.  It was reported that the vial was initially stored in refrigerator on 10-Nov-2022 and administered on 15-Nov-2022 08:45 AM. Only one vial underwent product storage error and size of the vial was 2.5ml. Vial was then stored in the room temperature. The vial did not undergo any temperature excursion. Total amount of time the vial  exposed to room temperature range (8° to 25°C= 46° to 77°F) was 17 hours.  Treatment information was not provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received Bivalent as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Bivalent as a first dose) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Bivalent as a first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Bivalent as a first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received Bivalent as a first dose).    No concomitant medication was reported.  No treatment medication was reported. The patient received bivalent vaccine as a first dose. The patient was on the clinic for second dose on 15-Nov-2022.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: It was given to 2 people beyond the 12 hr mark.; No adverse event; There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.), PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.) and NO ADVERSE EVENT (No adverse event) in a 24-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2022 at 3:05 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.), PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.) and PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.).    No concomitant medications were reported.  It was reported that total 2 patients received the Bivalent booster vaccines post 12 hours of punctured. 1 Vial and 2 doses were given with vial size of 2.5 ml. Vial was initially stored in the refrigerator on 04-Nov-2022. The vial was first punctured on 08-Nov-2022. The vial was stored in the Refrigerator post punctured. The vial did not undergo any temperature excursions. Vial remained Refrigerated within range.  No treatment medication details were reported.   This case was linked to MOD-2022-672831 (Linked Report).; Sender's Comments:  MOD-2022-672831: Patient case
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine that was administered outside of the 12 hour window/stored post puncture in room temperature; No adverse event; 1 patient received Moderna Covid-19 vaccine 12 hours after the vial had been punctured.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient received Moderna Covid-19 vaccine 12 hours after the vial had been punctured.), PRODUCT STORAGE ERROR (vaccine that was administered outside of the 12 hour window/stored post puncture in room temperature) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (LOT number was unknown, Expiration date 20-Feb-2022, Left Arm of administration.) on 21-Feb-2021, Moderna COVID-19 Vaccine (LOT number 031A21A, Expiration date 28-Aug-2021, Left Arm of administration.) on 23-Mar-2021, Moderna COVID-19 Vaccine (LOT number 939904, Expiration date 24-Jan-2022 and Left Arm of administration.) on 27-Oct-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 15-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. On 15-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient received Moderna Covid-19 vaccine 12 hours after the vial had been punctured.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine that was administered outside of the 12 hour window/stored post puncture in room temperature) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient received Moderna Covid-19 vaccine 12 hours after the vial had been punctured.), PRODUCT STORAGE ERROR (vaccine that was administered outside of the 12 hour window/stored post puncture in room temperature) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (1 patient received Moderna Covid-19 vaccine 12 hours after the vial had been punctured.) and PRODUCT STORAGE ERROR (vaccine that was administered outside of the 12 hour window/stored post puncture in room temperature).    No concomitant medication was provided by the reporter.  The vial was initially stored in the refrigerator on 07-NOV-2022. The vial was first punctured at room temperature on 14-Nov-2022 at 10:30.  The vials did not go under temperature excursion.  No treatment medication was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Throat irritation, Urticaria
Clinical narrative: Itchy throat; Hives; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Itchy throat) and URTICARIA (Hives) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included Vaccination adverse reaction with Pfizer and Pfizer.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (Itchy throat) and URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, THROAT IRRITATION (Itchy throat) and URTICARIA (Hives) outcome was unknown.            No concomitant medication was provided by the reporter.  It was reported that patient did not have a choice so chanced it and got Pfizer the 1st two times. It was not great but no overt allergic reaction. For the booster patient did moderna and took Benadryl. Again, not great but no face swelling. Just itchy throat and a few hives.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Influenza, Pain
Clinical narrative: It hurt; Influenza; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US2022AMR156058.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COVID-19", start date: Jul2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Anatomical location: left arm, in September), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "recovered", described as "It hurt"; INFLUENZA (non-serious), outcome "recovered".  Additional information: The patient got vaccinated in the left arm, and it did not hurt, in September, and after 2 months the second dose. They just applied, the new one from COVID and derivatives, from Pfizer, and the one from Fluo and it hurt. The patient had symptoms of both for 3 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Fatigue, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Covid symptoms were in my chest; exhaustion; 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 15Mar2021 at 15:45 as dose 1, single (Lot number: EP7533), in right arm, on 15Apr2021 as dose 2, single (Lot number: EW0169), in right arm, on 22Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FH8020), in right arm and on 15Jun2022 at 13:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "back fusion" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: lactose intolerant" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE SODIUM, start date: 19Jul2021 (ongoing). The following information was reported: CHEST DISCOMFORT (non-serious) with onset 2022, outcome "unknown", described as "Covid symptoms were in my chest"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "exhaustion". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medications in two weeks. Patient received Covid-19 treatment with Paxlovid from 13Oct2022 to 18Oct2022. Six days after completing patient final dose of Paxlovid, She had a "rebound". Patient original Covid symptoms were in her chest, exhaustion. Patient rebound was an intense head cold, exhaustion, dizziness. She felt worse during the rebound and it took over 10 days to recover - 10 days in addition to the 10 days of original Covid. Infrequently, Patient still become light headed.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: very bad case of corona virus in Jun, It took 3 months to get her voice back, she had breathing problems and low energy; very bad case of corona virus in Jun, It took 3 months to get her voice back, she had breathing problems and low energy; 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 77-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "very bad case of corona virus in Jun, It took 3 months to get her voice back, she had breathing problems and low energy".  Clinical course: She is 77 years old and had a very bad case of corona virus in Jun, It took 3 months to get her voice back, she had breathing problems and low energy. Caller also states she has had all her prior covid vaccinations from Pfizer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296155 same pt, diff event;
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 Omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years, in left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: FK9894), 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: "Chronic hepatitis B" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LISINOPRIL; TENOFOVIR. 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: (11Nov2022) Positive, notes: Tested positive using test on 11Nov2022; (unspecified date) Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, COVID-19.  Additional information: Other Medication Details: Tenofovir, Lisinopril, and Levothyroxine.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Illness
Clinical narrative: Went to be and was sick all night long. Got up, forced herself to go to work. Left at 2PM, went home and went to bed. Has been in bed ever since.; Has not had anything to eat yet. Had once cracker yesterday. Is trying to eat.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 at 14:30 as dose 5 (booster), single (Lot number: GH9697) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 25Sep2022 as dose number unknown, single. Vaccination history included: BNT162b2 (DOSE:1, Pfizer Covid-19 vaccine:, First Dose: 05Feb2021, LOT: EL9264, NDC, EXP: Unknown), administration date: 05Feb2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (DOSE: 2, Second Dose: 26Feb2021; 1115A, next to date on vaccine card, LOT: EN6203, NDC, EXP: Unknown), administration date: 26Feb2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (DOSE: 3, Third Dose: 25Sep2021, LOT: FF2589, NDC, EXP: Unknown), administration date: 25Sep2021, when the patient was 79-year-old, for Covid-19 immunization; BNT162b2 (DOSE: 4, Fourth Dose, Booster: 04Apr2022, LOT: FJ6369 , NDC, EXP: Unknown), administration date: 04Apr2022, when the patient was 80-year-old, for Covid-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 09Nov2022, outcome "recovering", described as "Went to be and was sick all night long. Got up, forced herself to go to work. Left at 2PM, went home and went to bed. Has been in bed ever since."; DECREASED APPETITE (non-serious) with onset Nov2022, outcome "recovering", described as "Has not had anything to eat yet. Had once cracker yesterday. Is trying to eat.". Therapeutic measures were taken as a result of illness, decreased appetite: Treatment: Took Tylenol. Additional information: Family Medical History Relevant to Adverse Events (AEs): No. Got flu shot 25Sep2022, was over 4 weeks prior to this last booster shot. Just takes her regular medications. At her age, does not want to be getting Covid. Patient has been in bed ever since and missed work today (at the time of report on 11Nov2022). Has been sick in bed at least 2 days with it. Got all the other 3 and never had this problem.
Sex: M
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: new onset systemic lupus erythematosus; This is a literature report.  A 54-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: "Sjogrens syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE (unknown manufacturer)), for Covid-19 immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "new onset systemic lupus erythematosus".; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug 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.
Sex: M
Vaccine: COVID19
Symptoms: Cutaneous lupus erythematosus
Clinical narrative: new onset cutaneous lupus erythematosus; This is a literature report.  A 70-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 and concomitant medications were not reported. History of autoimmune was none. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: CUTANEOUS LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "new onset cutaneous lupus erythematosus".  Clinical course: After 2nd dose Erythematous plaques noted as symptom. History of autoimmune was none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event 'new onset cutaneous lupus erythematosus' and the use of suspect product BNT162b2 cannot be fully excluded.The case will be reassessed once further information is available 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Vertigo
Clinical narrative: Body aches; Vertigo; Pain in joints; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 at 13:15 as dose 4 (booster), single (Lot number: GL0446) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; TRAZODONE. Vaccination history included: Covid-19 vaccine (DOSE: 01, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 02, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 03, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 12Nov2022 at 06:00, outcome "recovered", described as "Body aches"; ARTHRALGIA (non-serious) with onset 12Nov2022 at 06:00, outcome "recovered", described as "Pain in joints"; VERTIGO (non-serious) with onset 12Nov2022 at 06:00, outcome "recovered". Therapeutic measures were not taken as a result of arthralgia, pain, vertigo.  Additional information: No other vaccine was in four weeks. Other vaccine in two weeks were Crestor, Trazodone, multi vitamin.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: Soreness in right arm; chills; muscle soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 10:30 as dose 4 (booster), single (Lot number: GJ6742) at the age of 27 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergy: Penicillin" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, on 26Oct2022 as dose number unknown, single; KURVELO; FLUOXETINE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot no: EL3247; Route of administration: intramuscular; Location of injection: arm right), administration date: 25Jan2021, when the patient was 25-year-old, for COVID-19 Immunization, reaction(s): "slight soreness in my right arm"; BNT162b2 (DOSE 2, SINGLE; Lot No: EL3247; Route of administration: Intramuscular; Location of injection: Arm right), administration date: 15Feb2021, when the patient was 25-year-old, for COVID-19 Immunization, reaction(s): "fatigue", "My right arm was also a bit sore", "I had slight muscle soreness", "Very slight chills"; BNT162b2 (DOSE 3, SINGLE; Lot no: EW0217; Route of administration: Intramuscular; Location of injection: arm right), administration date: 14Oct2021, when the patient was 25-year-old, for COVID-19 Immunization, reaction(s): "Stomach ache", "Injection site slight pain", "Fatigue", "Chills". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Nov2022 at 21:00, outcome "recovering", described as "Soreness in right arm"; CHILLS (non-serious) with onset 10Nov2022 at 21:00, outcome "recovering"; MYALGIA (non-serious) with onset 10Nov2022 at 21:00, outcome "recovering", described as "muscle soreness". Therapeutic measures were not taken as a result of pain in extremity, chills, myalgia.  Additional information: It was reported that, the patient received other vaccine in four weeks. The patient had not been tested for COVID post vaccination. Other medical history was reported as no. Adverse events did not result in Emergency room visit or Physician office visit.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Some numbness between her elbow and wrist.She mentioned that someone else also had a similar adverse event; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Some numbness between her elbow and wrist.She mentioned that someone else also had a similar adverse event".  Additional information: Caller mentioned she already received 4 shot of the Pfizer-BioNTech COVID-19 Vaccine (2 shots for the primary series and 2 booster shots). She recently received the bivalent formulation and 3 days after the injection, she noticed some numbness between her elbow and wrist. She mentioned that someone else also had a similar adverse event and she wanted to know if this had been reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, SARS-CoV-2 test
Clinical narrative: in Oct2021 was diagnosed with Stage 3 hypertension/have elevated blood pressure readings after the 2nd shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2021 as dose 2, single (Lot number: EW0178) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JUNEL FE. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0172, Location of injection: Arm Left), administration date: 01May2021, when the patient was 16-year-old, for COVID-19 Immunisation. The following information was reported: HYPERTENSION (medically significant) with onset 01Jun2021, outcome "recovered with sequelae", described as "in Oct2021 was diagnosed with Stage 3 hypertension/have elevated blood pressure readings after the 2nd shot". The event "in oct2021 was diagnosed with stage 3 hypertension/have elevated blood pressure readings after the 2nd shot" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Elevated, notes: began to have elevated blood pressure readings after the 2nd shot; SARS-CoV-2 test: Negative, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of hypertension. Clinical course: No other vaccine in 4 weeks. The patient began to have elevated blood pressure readings after the 2nd shot and in Oct2021 was diagnosed with stage 3 hypertension. She recovered with lasting effects. Treatment included Lisinopril. Covid prior vaccination: No. Device timestamp: 12Nov2022.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; ATORVASTATIN; PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]; PRESERVISION; BENADRYL; MUCINEX DM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovered" (Nov2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2022) Negative; (10Nov2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment start date=02Nov2022, treatment stop date=06Nov2022. The patient tested negative for covid after paxlovid. She had a negative test on 08Nov and 10Nov. She had no symptoms. No Known allergies. Device timestamp: 13Nov2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Oxygen saturation, Tachypnoea, Wrong product administered
Clinical narrative: tachypnea; bivalent, dose number=1; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 1, single (Lot number: GJ6665) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Parkinson" (unspecified if ongoing); "Chronic Afib" (unspecified if ongoing). No known allergies. No covid prior vaccination. Was not covid tested post vaccination. Concomitant medication(s) included: ASA; WELLBUTRIN; PROTONIX [OMEPRAZOLE]; WARFARIN. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 08Nov2022, outcome "unknown", described as "bivalent, dose number=1"; TACHYPNOEA (hospitalization) with onset 11Nov2022, outcome "not recovered", described as "tachypnea". The event "tachypnea" required emergency room visit. The patient developed tachypnea, Pulse OX while on rebreather mask, 88%, EKG obtained, sent to Emergency Department. Therapeutic measures were taken as a result of tachypnoea. Event treatment included EKG, anticoagulant and oxygen.  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 event tachypnea and the use of suspect product BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded. The case will be reassessed once further information is available 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Electrocardiogram, Wrong product administered
Clinical narrative: Bivalent, Dose Number: 2; SOB; weakness; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 2, single (Lot number: GJ6665) at the age of 83 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "TIA" (unspecified if ongoing); "Heart Failure" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Pax AFIB" (unspecified if ongoing). No known allergies. No other vaccine in four weeks. No covid prior vaccination. Was not covid tested post vaccination. Concomitant medication(s) included: COUMADIN; POTASSIUM CHLORIDE; DONEPEZIL; LEXAPRO. Vaccination history included: Covid-19 vaccine (Dose 1, Batch/Lot No: Unknown), for COVID-19 Immunization. The following information was reported: DYSPNOEA (medically significant) with onset 08Nov2022, outcome "recovering", described as "SOB"; ASTHENIA (medically significant) with onset 08Nov2022, outcome "recovering", described as "weakness"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Bivalent, Dose Number: 2". The patient underwent the following laboratory tests and procedures: Electrocardiogram (EKG): unknown results. Therapeutic measures were taken as a result of dyspnoea, asthenia. Events treatment included oxygen and EKG.  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 events dyspnoea, asthenia with the suspect product BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5),  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.