chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly 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. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      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 EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly 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. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) 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 EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.  This case contains the information of 8th out of 13 elderly patient who received the vaccine as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-688372 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688372:
Sex: U
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse event; 13 elderly patients received a 2nd Bivalent booster on 16DEC2022, 2 months after the first Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (13 elderly patients received a 2nd Bivalent booster on 16DEC2022, 2 months after the first Bivalent booster) and NO ADVERSE EVENT (No Adverse event) in an elderly 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. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.   In October 2022, 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 16-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 16-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (13 elderly patients received a 2nd Bivalent booster on 16DEC2022, 2 months after the first Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (13 elderly patients received a 2nd Bivalent booster on 16DEC2022, 2 months after the first Bivalent booster) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      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 EXTRA DOSE ADMINISTERED (13 elderly patients received a 2nd Bivalent booster on 16DEC2022, 2 months after the first Bivalent booster).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.  This case contains information for the 9th of 13 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-688372 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688372:master case 1 of 13
Sex: U
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly 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. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022 at 6:18 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022 at 6:18 PM, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      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 EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.  This case contains the information of 10th out of 13 elderly patient who received the vaccine as described by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly 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. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022 at 6:18 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022 at 6:18 PM, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      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 EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.  This case contains the information of 11th out of 13 elderly patient who received the vaccine as described by the reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688372:master case
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly 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. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) 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 EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.  This case contains the information of 12th out of 13 elderly patient who received the vaccine as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-688372 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688372
Sex: U
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly 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. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022 at 6:18 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022 at 6:18 PM, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      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 EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.  This case contains the information of 13th out of 13 elderly patient who received the vaccine as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-688372 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688372:master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.; serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.), POOR QUALITY PRODUCT ADMINISTERED (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    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 PRODUCT TEMPERATURE EXCURSION ISSUE (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.), POOR QUALITY PRODUCT ADMINISTERED (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.) and POOR QUALITY PRODUCT ADMINISTERED (serious of excursions happened to some vials of Moderna COVID-19 Vaccine monovalent and bivalent from 21Nov2022 to 8Dec2022.) outcome was unknown.            Concomitant products were not reported.  It was reported that unknown number of patients where vaccinated in a mobile unit after a serious of excursions happened to some vials of Moderna COVID-19 Vaccine bivalent from 21-Nov-2022 to 8-Dec-2022. Age group was from infant to adults.  Treatment medications were not reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: REBOUND COVIDS/ COVID 19 Treatment; REBOUND COVIDS/ COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 5 (booster), single (Lot number: 6yk24) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 15Feb2021 as dose 2, single (Lot number: EN9581), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: FD8448) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Feb2022 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VERAPAMIL; ATORVASTATIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Oct2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Dec2022, outcome "recovering" and all described as "REBOUND COVIDS/ COVID 19 Treatment". Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 27Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus SLE" (unspecified if ongoing); "Lupus Nephritis" (unspecified if ongoing); "Known allergies shellfish" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE; CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]; HYDROXYCHLOROQUINE. Past drug history included: Rituximab, reaction(s): "Allergy". 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.  Clinical course: Patient received Paxlovid as COVID-19 treatment 08Dec2022 to 12Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Patient presents today with an injection site reaction.; Redness have increased over the past couple of days.; welling have increased over the past couple of days.; States it hurt immediately after receiving it.; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 62-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 14Dec2022 at 09:00 as dose 1, single (Lot number: GF7610) at the age of 62 years, in left deltoid for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "colon cancer" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Allergy". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Dec2022, outcome "unknown", described as "States it hurt immediately after receiving it."; VACCINATION SITE REACTION (non-serious) with onset 15Dec2022, outcome "unknown", described as "Patient presents today with an injection site reaction."; VACCINATION SITE ERYTHEMA (non-serious) with onset 15Dec2022, outcome "unknown", described as "Redness have increased over the past couple of days."; VACCINATION SITE SWELLING (non-serious) with onset 15Dec2022, outcome "unknown", described as "welling have increased over the past couple of days.". Therapeutic measures were taken as a result of vaccination site reaction, vaccination site pain, vaccination site erythema, vaccination site swelling.  Clinical course: Patient presents today with an injection site reaction. She was given Prevnar-20 two days ago in-office. States it hurt immediately after receiving it. Site continues to be painful. Redness and swelling have increased over the past couple of days. She has tried ice packs and Tylenol at home for relief. Took one dose of ibuprofen. Denies any fever or drainage from the site. Facility where vaccine was administered: Doctor's office/urgent care. Patient did not received any other vaccines on the same date as the vaccine(s). It was unknown that patient received any other vaccines within 4 weeks Prior to the vaccine(s) and any other medications within 2 weeks of the event starting. Prednisone (Deltasone) 20 MG tablet, taken 3 tablets by mouth daily for 3 days, Then 2 tablet as treatment received.
Sex: U
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: only 1 other person in the hospital who responded with reaction and having blisters head to toe; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  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: BLISTER (medically significant), outcome "unknown", described as "only 1 other person in the hospital who responded with reaction and having blisters head to toe".  Additional information: Only 1 other person in the hospital who responded with reaction and having blisters head to toe. No one else in the whole hospital that was vaccinated had any of these reactions. Was just the 2 of them.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available,The casual association between the reported event "BLISTER" and suspected drug cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment with Paxlovid; COVID 19 Treatment with Paxlovid; 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 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: fp7138) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: en6202), on 23Mar2021 as dose 2, single (Lot number: ep6955), on 25Oct2021 as dose 3 (booster), single (Lot number: ah8020) and on 06May2022 as dose 4 (booster), single (Lot number: fp4554) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment with Paxlovid". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: No known allergies. The patient received Paxlovid treatment from 10Dec2022 to 15Dec2022.
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Visual impairment
Clinical narrative: she can't see she can't get in the highway to drive; she can't get in the highway to drive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient 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: VISUAL IMPAIRMENT (medically significant), outcome "unknown", described as "she can't see she can't get in the highway to drive"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "she can't get in the highway to drive". Clinical course: Patient was a nurse and worked in operating room and had to go to the hospital she could not see she could not get in the highway to drive, and this was a side effect of the vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course : The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received COVID-19 treatment with oral paxlovid from 05Dec2022 till 10Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected drug cannot be completely excluded.
Age: 57.0
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 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 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: "PCOS" (unspecified if ongoing), notes: PCOS; "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Quinine, reaction(s): "Allergy_Quinine"; Sucralose, reaction(s): "Allergy_Sucralose". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reported that, COVID-19 treatment Paxlovid was started on unspecified date in Dec2022. Last dose was on Saturday, 10Dec2022. After taking Paxlovid, Patient had rebound of COVID. Rebound COVID symptoms returned on Friday 16Dec2022 and patient took an at home test that was positive. Patient was recovering from COVID symptoms and no treatment received for symptoms. Patient was taking other medications or products within 2 weeks of starting COVID-19 treatment included Nyquil (started and stopped on 04Dec2022).  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.
Sex: F
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 4 (booster), single (Lot number: GH9694) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient received COVID-19 treatment with Paxlovid from 06Dec2022 to 10Dec2022.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate increased, Heart rate irregular, Supraventricular tachycardia
Clinical narrative: Arrhythmia; Rapid Heartbeat the evening after the vaccination; I have since been diagnosed with Supraventricular tachycardia (SVT); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: EW0151) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6208), administration date: 10Mar2021, when the patient was 37-year-old, for COVID-19 immunization. The following information was reported: ARRHYTHMIA (medically significant) with onset 07Apr2021, outcome "not recovered"; SUPRAVENTRICULAR TACHYCARDIA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "I have since been diagnosed with Supraventricular tachycardia (SVT)"; HEART RATE INCREASED (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Rapid Heartbeat the evening after the vaccination". The events "arrhythmia", "rapid heartbeat the evening after the vaccination" and "i have since been diagnosed with supraventricular tachycardia (svt)" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate irregular: (07Apr2021) Rapid Heartbeat, notes: Rapid Heartbeat the evening after the vaccination.  Clinical course: Rapid Heartbeat the evening after the vaccination. she had since been diagnosed with Supraventricular tachycardia (SVT) and have had ongoing problems with rapid heart rate and arrhythmia. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, had the patient been tested for COVID-19.There was none known allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Pain, Sinus congestion
Clinical narrative: Extreme achiness; extreme fatigue; clogged sinuses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: COVID prior vaccination: Yes. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot No: El3247; Anatomical site: arm Left), administration date: 01Mar2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot No: EP6955; Anatomical site: arm Left), administration date: 24Mar2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot No: FL3197;, Anatomical site: arm Left), administration date: 19Jan2022, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 17Dec2022, outcome "recovering", described as "Extreme achiness"; SINUS CONGESTION (non-serious) with onset 17Dec2022, outcome "recovering", described as "clogged sinuses"; FATIGUE (non-serious) with onset 17Dec2022, outcome "recovering", described as "extreme fatigue". Therapeutic measures were not taken as a result of pain, fatigue, sinus congestion.  Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. The patient received medications within two weeks of vaccination included Protoxin. The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "afib" (unspecified if ongoing); "hyperlipidemia" (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 "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (16Dec2022) Negative, notes: positive RAT on 19Dec (previously negative on 16Dec); (19Dec2022) Positive, notes: positive RAT on 19Dec (previously negative on 16Dec). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient taken anti-viral drug paxlovid from 11Dec2022 to 16Dec2022 via oral route for treatment of COVID-19. The patient experienced rebound covid with fever and positive RAT on 19Dec (previously negative on 16Dec) and patient recovering from rebound covid. Patient did not have any known drug allergies. The other medication received in 2 weeks was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and covid-19 with the suspect drug BNT162b2, BNT162b2 omi ba.4-5 cannot be excluded. The case will be reassessed once new information is available.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Sep2022 at 12:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 32 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin", notes: known allergies: Augmentin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (18Dec2022) Positive, notes: positive test two days after ending full Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given for COVID 19 treatment. Return of COVID symptoms and positive test two days after ending full Paxlovid treatment.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Pyrexia, SARS-CoV-2 test
Clinical narrative: test positive; test positive; Pfizer COVID-19 vaccine and booster except 1 Moderna booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Feb2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Feb2022, outcome "unknown", described as "Pfizer COVID-19 vaccine and booster except 1 Moderna booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "test positive". The patient underwent the following laboratory tests and procedures: Pyrexia: (Dec2022) 101.4, notes: 101.4; (Dec2022) 100, notes: 100; SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19-2, UNK, COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (086396). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; palbociclib (IBRANCE), since 2018 at 75 mg for breast cancer female. The patient's relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunisation; Bnt162b2 (Dose number unknown booster (2nd booster)), for COVID-19 immunisation, reaction(s): "arm a little sore". The following information was reported: FATIGUE (non-serious), outcome "recovering". The action taken for palbociclib was unknown.  Additional information: Patient stated the last few weeks she has been experiencing fatigue. She stated this could be due to getting her third COVID booster shot. She stated the second booster shot made her arm a little sore but after this one the fatigue has lasted a couple weeks and it is very clearly fatigue, not just being tired. She was starting to feel better now. She has been on Ibrance since 2018. Also reported she was diabetic and was four years into this and it wasn't getting any easier.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200128174 same patient/different suspect drug and AE;
Sex: F
Vaccine: COVID19-2, UNK, COVID19
Symptoms: Pain in extremity
Clinical narrative: Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (086396). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; palbociclib (IBRANCE), since 2018 at 75 mg for breast cancer female. The patient's relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunisation; Bnt162b2 (Dose number unknown booster (2nd booster)), for COVID-19 immunisation, reaction(s): "arm a little sore". The following information was reported: FATIGUE (non-serious), outcome "recovering". The action taken for palbociclib was unknown.  Additional information: Patient stated the last few weeks she has been experiencing fatigue. She stated this could be due to getting her third COVID booster shot. She stated the second booster shot made her arm a little sore but after this one the fatigue has lasted a couple weeks and it is very clearly fatigue, not just being tired. She was starting to feel better now. She has been on Ibrance since 2018. Also reported she was diabetic and was four years into this and it wasn't getting any easier.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200128174 same patient/different suspect drug and AE;
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got really sick; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "C-section" (unspecified if ongoing); "Multiple Sclerosis" (ongoing); "Allergy to band-aids" (ongoing); "Allergy to Latex" (ongoing). Concomitant medication(s) included: OCREVUS (ongoing); BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE] (ongoing); MIRALAX (ongoing). Past drug history included: Betadine, reaction(s): "Allergy to Betadine". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got really sick".  Additional information: On 01Nov2021, patient started therapy with Covid-19 Vaccine Pfizer for Covid. On unknown date, it was reported that patient experienced got really sick.  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) : 4799128
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: it did make me sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (180628). The reporter is the patient.  A 26-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "it did make me sick".  Clinical course: Reporter is not a Healthcare professional. Pfizer vaccine was a good one but it didnt make it any worse because the first shot didnt make the symptoms go back as well so they had a lot more to say but it did make her sick so she was glad that they didnt have any symptoms and she dont think it would make a big deal if it did not cause the virus but she guess.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I became COVID positive 18Aug; I became COVID positive 18Aug; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Aug2022, outcome "recovered" and all described as "I became COVID positive 18Aug". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2022) Positive, notes: I became COVID positive 18Aug.  Clinical course: patient became Covid positive 18Aug. After feeling mild-moderate symptoms for 36 hours, patient was back on feet.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Rhinorrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 77-year-old patient 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: RHINORRHOEA (non-serious), outcome "unknown", described as "Rhinorrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.