chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 20 month old given monovalent for first dose and then given bivalent vaccine as the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (20 month old given monovalent for first dose and then given bivalent vaccine as the second dose) and NO ADVERSE EVENT (No adverse event) in a 1-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     The patient received no other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 21-Feb-2023, 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 21-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (20 month old given monovalent for first dose and then given bivalent vaccine as the second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (20 month old given monovalent for first dose and then given bivalent vaccine as the second 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (20 month old given monovalent for first dose and then given bivalent vaccine as the second dose).    The 20 month old male patient was given monovalent vaccine as the first dose. There was no harm to patient with no side effects.  The concomitant medication was not reported. The treatment medication was not reported.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Caller reports that his wife received her Moderna Primary Series vaccine and two Moderna booster doses and that his wife caught Covid-19 in December 2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Caller reports that his wife received her Moderna Primary Series vaccine and two Moderna booster doses and that his wife caught Covid-19 in December 2022) in an adult female patient 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 COVID-19 prophylaxis: Spikevax, Moderna COVID-19 Vaccine and Spikevax. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Spikevax and Spikevax.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced COVID-19 (Caller reports that his wife received her Moderna Primary Series vaccine and two Moderna booster doses and that his wife caught Covid-19 in December 2022). At the time of the report, COVID-19 (Caller reports that his wife received her Moderna Primary Series vaccine and two Moderna booster doses and that his wife caught Covid-19 in December 2022) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.   Reporter did not allow further contact
Age: 1.33
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 16-month-old patient received expired first monovalent primary dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (16-month-old patient received expired first monovalent primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 16-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    In February 2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (16-month-old patient received expired first monovalent primary dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (16-month-old patient received expired first monovalent primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (16-month-old patient received expired first monovalent primary dose of Moderna COVID-19 vaccine).    No concomitant medication were reported.  It was reported that a 16 month old patient received expired first monovalent primary dose of Moderna COVID-19 vaccine on unknown date after 14-FEB-2023. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Moderna Covid-19 monovalent were administered BUD; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD).    Concomitant medications details were not reported by the reporter.  This case was considered for 1st adult patient out of 15 recipients who received moderna vaccine after by used date.  Treatment details were not reported by the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; a patient who received 2 Bivalent boosters of Moderna Covid 19 Bivalent/1st Bivalent booster was given on 03Oct2022 and the second one on 15Dec2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (a patient who received 2 Bivalent boosters of Moderna Covid 19 Bivalent/1st Bivalent booster was given on 03Oct2022 and the second one on 15Dec2023) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Dec-2022, received fourth 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 15-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (a patient who received 2 Bivalent boosters of Moderna Covid 19 Bivalent/1st Bivalent booster was given on 03Oct2022 and the second one on 15Dec2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (a patient who received 2 Bivalent boosters of Moderna Covid 19 Bivalent/1st Bivalent booster was given on 03Oct2022 and the second one on 15Dec2023) 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 (a patient who received 2 Bivalent boosters of Moderna Covid 19 Bivalent/1st Bivalent booster was given on 03Oct2022 and the second one on 15Dec2023).    No concomitant medications were reported.  Patient received first Monovalent Dose on 28Feb2021 and second Monovalent Dose on 01Apr2021. Patient received no any other vaccines in the 4 weeks prior to COVID-19.   No treatment medications were reported.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 2ND DOSE Dec 28 2022/ 3RD DOSE 28Feb2023; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2ND DOSE Dec 28 2022/ 3RD DOSE 28Feb2023) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1903B, AS1417B and AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2023, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 28-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2ND DOSE Dec 28 2022/ 3RD DOSE 28Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2ND DOSE Dec 28 2022/ 3RD DOSE 28Feb2023) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2ND DOSE Dec 28 2022/ 3RD DOSE 28Feb2023).    No concomitant medications were reported. It was Unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient was not immunocompromised. No treatment details were reported.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: On 26-Jan-2023, the vial was initially stored in the refrigerator and on 27-Feb-2023 administration of vaccine; No adverse event; Patient received expired Bivalent Moderna COVID-19 vaccine beyond 30 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine beyond 30 days in the refrigerator), PRODUCT STORAGE ERROR (On 26-Jan-2023, the vial was initially stored in the refrigerator and on 27-Feb-2023 administration of vaccine) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Feb-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine beyond 30 days in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 26-Jan-2023, the vial was initially stored in the refrigerator and on 27-Feb-2023 administration of vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Moderna COVID-19 vaccine beyond 30 days in the refrigerator), PRODUCT STORAGE ERROR (On 26-Jan-2023, the vial was initially stored in the refrigerator and on 27-Feb-2023 administration of vaccine) 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 (Patient received expired Bivalent Moderna COVID-19 vaccine beyond 30 days in the refrigerator) and PRODUCT STORAGE ERROR (On 26-Jan-2023, the vial was initially stored in the refrigerator and on 27-Feb-2023 administration of vaccine).    The concomitant medication was not reported by reporter. The intact carton vial was used and vial size was 2.5 ml. On 26-Jan-2023, the vial was initially stored in the refrigerator and on 27-Feb-2023 administration of vaccine. The vial did not undergo any temperature excursions. The treatment medication was not reported by reporter.
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Patient came down with a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patient came down with a rash) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     The medical history was unknown.     On 04-Feb-2023, 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 13-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced RASH (Patient came down with a rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (Patient came down with a rash) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  Dose of suspect Moderna Bivalent was reported as Booster. Patient went to the doctor and was prescribed antihistamine Zyrtec but currently rash was still persistent. Patient mentioned appointment was scheduled to see a doctor on 17-MAR-2023.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site pain
Clinical narrative: that she is still having some pain at the injection site (left arm) after getting her last dose on 14Sep2022; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (that she is still having some pain at the injection site (left arm) after getting her last dose on 14Sep2022) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Breast cancer (breast cancer diagnosed in Oct2018) in October 2018. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose, lot number -026L20A) on 22-Jan-2021, Moderna COVID-19 Vaccine (2nd dose, lot number -015M20A) on 19-Feb-2021, Moderna COVID-19 Vaccine (3rd dose, lot number -007C21A) on 19-Aug-2021, Moderna COVID-19 Vaccine (1st booster dose and lot number-033K21-2A) on 19-Mar-2022; for Product used for unknown indication: Flu. Past adverse reactions to the above products included No adverse event with Flu, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) and ANASTROZOLE for an unknown indication.    On 14-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Sep-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VACCINATION SITE PAIN (that she is still having some pain at the injection site (left arm) after getting her last dose on 14Sep2022). At the time of the report, VACCINATION SITE PAIN (that she is still having some pain at the injection site (left arm) after getting her last dose on 14Sep2022) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was reported.  Patient not sure if it was the 3rd dose or the 1st booster dose that she got in Aug2021. Patient states that the left arm is much better now. Patient feels the pain when the weather is bad but patient now can sleep and patient tell that the pain had improved. Patient had flu vaccine a few weeks after got her last dose of the Covid-19 vaccine. Patient cannot remember the date.
Sex: U
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: would like to know if an adult only got the .25 , does the patient need to do anything or come back in for another 0.25mL of the Bivalent vaccine?/It would be 0.25mL of the Moderna Bivalent 6 year and up; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (would like to know if an adult only got the .25 , does the patient need to do anything or come back in for another 0.25mL of the Bivalent vaccine?/It would be 0.25mL of the Moderna Bivalent 6 year and up) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (would like to know if an adult only got the .25 , does the patient need to do anything or come back in for another 0.25mL of the Bivalent vaccine?/It would be 0.25mL of the Moderna Bivalent 6 year and up) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (would like to know if an adult only got the .25 , does the patient need to do anything or come back in for another 0.25mL of the Bivalent vaccine?/It would be 0.25mL of the Moderna Bivalent 6 year and up) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (would like to know if an adult only got the .25 , does the patient need to do anything or come back in for another 0.25mL of the Bivalent vaccine?/It would be 0.25mL of the Moderna Bivalent 6 year and up).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: Bed ridden; 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 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: BEDRIDDEN (non-serious), outcome "unknown", described as "Bed ridden".  Additional information: It was reported by the patient that "When are you guys going to fix the damage you have done with this vaccine my life has been hell for two years since getting the vaccine. I have been bed ridden. Doctors won't do anything to help fix. Fix the damage you have done this is ridiculous".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01May2022 as dose 4 (booster), single (Lot number: FJ6369) for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EP6955), on 01Apr2021 as dose 2, single (Lot number: EW0171) and on 01Oct2021 as dose 3 (booster), single (Lot number: FE3590) for covid-19 immunisation. The patient's relevant medical history included: "DIC" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 21Feb2023 to 25Feb2023.  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
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2weeks: Yes. The patient was received Paxlovid (Treatment start date: 10Feb2023, Treatment stop date: 15Feb2023). Known allergies: No, Other medical history: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective , Covid-19 and the use of suspect product BNT162b2 cannot be fully excluded.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. 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 21Sep2022 as dose number unknown (booster), single (Lot number: Gh9694) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23May2022 as dose number unknown, single (Lot number: Fk9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Premature ventricular contractions" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which was COVID 19 Treatment, brand: Pfizer, from 10Feb2023 to 14Feb2023.
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 (Pharmacist). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM, start date: 01May2022. 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: Positive, notes: my Covid test was positive at the same time. Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Paxlovid.  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: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: EW0158), in left arm, on 03May2021 as dose 2, single (Lot number: EW0173), in right arm, on 15Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "dural sinus venus thrombosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient had no known allergies.
Sex: U
Vaccine: COVID19
Symptoms: Periorbital oedema
Clinical narrative: has caused continuous periorbital edema and put me in ER today; 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 patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PERIORBITAL OEDEMA (non-serious), 1 day after the suspect product(s) administration, outcome "not recovered", described as "has caused continuous periorbital edema and put me in ER today". The events "has caused continuous periorbital edema and put me in er today" required emergency room visit.  Additional information: Patient had Pfizer #1& #2 dose of covid vaccine. Then patient had "3 booster and after #4 newest, the latest has caused continuous periorbital edema and put me in ER today after almost 4 months.  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: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid infection in Dec.; Covid infection in Dec.; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm, as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, on 06Oct2022 as dose 1, single; AMLODIPINE; METOPROLOL; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D3. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening) all with onset Dec2022, outcome "recovering" and all described as "Covid infection in Dec. ". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 10 day(s)). The event "covid infection in dec. " required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Unknwon results, notes: Covid test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A causal relationship to the suspect drugs cannot be excluded for events lack of efficacy and COVID-19. This case will be reassessed upon receipt of additional information. 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.,Linked Report(s) : US-PFIZER INC-202300085695 similar report from the same reporter;US-PFIZER INC-202300085696 similar report from the same reporter;US-PFIZER INC-202300085697 similar report from the same reporter;
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrioventricular block, Cardiac sarcoidosis, Dyspnoea exertional, Electrocardiogram, Electrocardiogram abnormal
Clinical narrative: Covid infection in Dec.; Covid infection in Dec.; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm, as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, on 06Oct2022 as dose 1, single; AMLODIPINE; METOPROLOL; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D3. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening) all with onset Dec2022, outcome "recovering" and all described as "Covid infection in Dec. ". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 10 day(s)). The event "covid infection in dec. " required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Unknwon results, notes: Covid test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A causal relationship to the suspect drugs cannot be excluded for events lack of efficacy and COVID-19. This case will be reassessed upon receipt of additional information. 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.,Linked Report(s) : US-PFIZER INC-202300085695 similar report from the same reporter;US-PFIZER INC-202300085696 similar report from the same reporter;US-PFIZER INC-202300085697 similar report from the same reporter;
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Investigation, SARS-CoV-2 test, Trifascicular block
Clinical narrative: Covid infection in Dec.; Covid infection in Dec.; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm, as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation, on 06Oct2022 as dose 1, single; AMLODIPINE; METOPROLOL; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D3. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening) all with onset Dec2022, outcome "recovering" and all described as "Covid infection in Dec. ". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 10 day(s)). The event "covid infection in dec. " required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Unknwon results, notes: Covid test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A causal relationship to the suspect drugs cannot be excluded for events lack of efficacy and COVID-19. This case will be reassessed upon receipt of additional information. 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.,Linked Report(s) : US-PFIZER INC-202300085695 similar report from the same reporter;US-PFIZER INC-202300085696 similar report from the same reporter;US-PFIZER INC-202300085697 similar report from the same reporter;
Sex: F
Vaccine: COVID19-2
Symptoms: Joint swelling, Oedema, Peripheral swelling, Ultrasound scan
Clinical narrative: experienced both ankles swelling; swelling of the legs, a little bit of fluid; experienced both ankles swelling/swelling of the legs, a little bit of fluid/it may be idiopathic; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 45-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. The patient's relevant medical history included: "type-I diabetes" (unspecified if ongoing), notes: type-I diabetes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: JOINT SWELLING (non-serious), outcome "unknown", described as "experienced both ankles swelling"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling of the legs, a little bit of fluid"; OEDEMA (non-serious), outcome "unknown", described as "experienced both ankles swelling/swelling of the legs, a little bit of fluid/it may be idiopathic". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter is a physician (family doctor) who has a patient with Type-I diabetes who experienced both ankles swelling, had swelling of the legs, a little bit of fluid, who received the Pfizer COVID-19 vaccine bivalent booster for adults a week before. The physician said that he thinks it was not vaccine related, it may be idiopathic, but he still thought he would call for the patient to see what he could find out. The physician also mentioned that the patient's ultrasound was clean (06Jan). The reporter clarified that there was no pain on ankles. The patient wanted to know if the Pfizer vaccine had anything to do with it or if there were any reports of ankle swelling. The reporter considered "experienced both ankles swelling", "swelling of the legs, a little bit of fluid" and "experienced both ankles swelling/swelling of the legs, a little bit of fluid/it may be idiopathic" not related to BNT162b2, BNT162b2 omi ba.4-5.  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: Based on the information currently available and currently known drug safety profile, the reported events more likely represented intercurrent illnesses, but not related to BNT162b2, BNT162b2 omi ba.4-5.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Pfizer COVID 19 vaccine: got COVID; Pfizer COVID 19 vaccine: got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Lot number: EW0162) and on 08May2021 as dose 2, single (Lot number: EW0169) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "several TIA's (Transient ischaemic attack) years ago when birth control pills" (unspecified if ongoing), notes: several TIA's (Transient ischaemic attack) years ago when birth control pills; "high blood pressure diagnosed probably 20 years ago" (unspecified if ongoing), notes: high blood pressure diagnosed probably 20 years ago. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. The patient takes blood pressure pill and a daily aspirin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Pfizer COVID 19 vaccine: got COVID". Therapeutic measures, Paxlovid from 25Feb2023, were taken as a result of vaccination failure, covid-19.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Dose 4= Moderna, Dose 5=Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13May2022 at 14:00 as dose 4 (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), 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: "Anaemia" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "Allergy"; Aspirin, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13May2022 at 14:00, outcome "unknown", described as "Dose 4= Moderna, Dose 5=Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested negative days 6 to 11; (Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 08Feb2023 to 12Feb2023.  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: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 27Feb2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 93-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 12Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 92 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 04Sep2021, outcome "unknown" and all described as "COVID". The patient was hospitalized for drug ineffective, covid-19 (start date: 08Sep2021). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Probable started about 04Sep2021, was given 2 shots. 9-4-didnt knew at that time. On way to High school reunion, felt a little odd then, stopped, no conclusion sought felt ok at reunion. Patient was back on the same day, felt very unpleasant. Saturday, went to (withheld). Monday, woke up, was 08Sep2021, patient knew he was sick. Called physician, about 20 minutes, told patient he had the COVID and was admitted.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back injury, Gout, Pneumonia
Clinical narrative: COVID; COVID; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 27Feb2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 93-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 12Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 92 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 04Sep2021, outcome "unknown" and all described as "COVID". The patient was hospitalized for drug ineffective, covid-19 (start date: 08Sep2021). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Probable started about 04Sep2021, was given 2 shots. 9-4-didnt knew at that time. On way to High school reunion, felt a little odd then, stopped, no conclusion sought felt ok at reunion. Patient was back on the same day, felt very unpleasant. Saturday, went to (withheld). Monday, woke up, was 08Sep2021, patient knew he was sick. Called physician, about 20 minutes, told patient he had the COVID and was admitted.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.