chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided    The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant and treatment medication was reported.  No other information was available at the time.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:MASTER  CASE
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    This case belongs to 3 of 20 patients described by the reporter.  No concomitant and treatment medications were reported.  20 Patients received Spikevax past the 30 day expiration date. No Other information was available at this time. Pharmacist provides permission for Safety to contact him via e-mail.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date), PRODUCT STORAGE ERROR (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date), PRODUCT STORAGE ERROR (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date), PRODUCT STORAGE ERROR (20 Patients received Spikevax past the 30 day expiration date) 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 (20 Patients received Spikevax past the 30 day expiration date) and PRODUCT STORAGE ERROR (20 Patients received Spikevax past the 30 day expiration date).    This case belongs to patient number 4 of 20 patients. Concomitant and treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:MASTER  CASE
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    This case belongs to 5 of 20 patients described by the reporter.  No concomitant and treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:MASTER  CASE
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medications were reported. No treatment information was provided. The case contains information of 6th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:MASTER  CASE
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medications were reported. No treatment information was provided. The case contains information of 11th patient out of 20 patients.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medications were reported. No treatment information was provided. The case contains information of 7th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:MASTER  CASE
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medications were reported. No treatment information was provided. The case contains information of 8th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:MASTER  CASE
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medications were reported. No treatment information was provided. The case contains information of 9th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:MASTER  CASE
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medications were reported. No treatment information was provided. The case contains information of 12th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medications were reported. No treatment information was provided. The case contains information of 10th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:MASTER  CASE
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medications were reported. No treatment information was provided. The case contains information of 13th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Adult patient received doses after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received doses after its expiration date 13-Jul-2022).    No concomitant medications were reported.  It was reported that, the patient received vaccine from expired vial. Further it was stated that, there were no remaining vials unused of expired lot number.  The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 52nd of 56 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19/she had a cold or sinuses or something) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (She had received three Moderna shots before). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    In January 2022, the patient received fourth dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced COVID-19 (COVID-19/she had a cold or sinuses or something). At the time of the report, COVID-19 (COVID-19/she had a cold or sinuses or something) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and Treatment medication was not provided.  The patient stated that she had a cold or sinuses or something and how long she should wait to get a bivalent booster for the COVID shot. She had received three Moderna shots before. She had her last booster in January 2022 but got COVID in August 2022. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Giving 0.25 ml instead of 0.2 ml; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Giving 0.25 ml instead of 0.2 ml) and NO ADVERSE EVENT (No Adverse Event) in a child 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. 215L22A) 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) .25 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Giving 0.25 ml instead of 0.2 ml) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, INCORRECT DOSE ADMINISTERED (Giving 0.25 ml instead of 0.2 ml) 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 INCORRECT DOSE ADMINISTERED (Giving 0.25 ml instead of 0.2 ml).    Concomitant and treatment medications were not reported.  It was reported that the nurse was at a pediatric practice. They gave monovalent and bivalent Moderna vaccine. They gave the wrong dose of the bivalent (6 months to 5 years) with lot number 215K22A. They gave 0.25 ml instead of 0.2 ml from14-Dec-2022 to 11-Jan-2023. She wants to know any recommendations to give the patients or what concerns to warn the parents. No parents had been contacted yet, no reports of adverse reactions received by the nurse. The nurse thinks there may be less than 10 patients involved. She may be able to email the information if necessary, but she does not had everything on hand at the moment. She will also had to check with the practice owner for release of that information.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: A patient received half of a dose of Moderna COVID-19 Vaccine Bivalent instead of full dose by accident; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (A patient received half of a dose of Moderna COVID-19 Vaccine Bivalent instead of full dose by accident) 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)) (batch no. ASKU) 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 ACCIDENTAL UNDERDOSE (A patient received half of a dose of Moderna COVID-19 Vaccine Bivalent instead of full dose by accident) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (A patient received half of a dose of Moderna COVID-19 Vaccine Bivalent instead of full dose by accident) 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 ACCIDENTAL UNDERDOSE (A patient received half of a dose of Moderna COVID-19 Vaccine Bivalent instead of full dose by accident).    No concomitant medications were reported.  No treatment information was reported.  It was stated that a patient received half of a dose of Moderna COVID-19 Vaccine and bivalent instead of full dose by accident. No patient identifiers or additional information on the case and also, and also reporter was running out of time would not submit a report but would let the colleagues know to report the AE later. It was unknown if patient experienced any AEs after the vaccine was given.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 20 Patients received Spikevax past the 30 day expiration date; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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)) (batch no. 023C22A) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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 EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    No concomitant medications were reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701001, US-MODERNATX, INC.-MOD-2023-701033, US-MODERNATX, INC.-MOD-2023-701057, US-MODERNATX, INC.-MOD-2023-701080, US-MODERNATX, INC.-MOD-2023-701104, US-MODERNATX, INC.-MOD-2023-701107, US-MODERNATX, INC.-MOD-2023-701147, US-MODERNATX, INC.-MOD-2023-701172, US-MODERNATX, INC.-MOD-2023-701191, US-MODERNATX, INC.-MOD-2023-701204 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701147:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701172:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701057:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701104:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701033:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701107:Master case US-MODERNATX, INC.-MOD-2023-701080:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701001:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701191:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701204:MASTER  CASE US-MODERNATX, INC.-MOD-2023-701196:Master case
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I had a very mild case of Covid-19 in July 2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I had a very mild case of Covid-19 in July 2022) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Chemotherapy, Mitral valve replacement in 2008 and Thyroidectomy in 2001. Concurrent medical conditions included Cardiomyopathy, Premature beats, Neuropathy and Osteopenia. Concomitant products included LISINOPRIL, SPIRONOLACTONE and CARVEDILOL for an unknown indication.   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. In July 2022, the patient experienced COVID-19 (I had a very mild case of Covid-19 in July 2022). At the time of the report, COVID-19 (I had a very mild case of Covid-19 in July 2022) had resolved.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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.   Treatment medications were not reported.   Reporter did not allow further contact
Sex: F
Vaccine: UNK
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Chest X-ray abnormal, Death, Drug interaction
Clinical narrative: drug interaction; COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS; acute hypoxemic respiratory failure; septic shock; This is a literature report for the following literature source(s):  A 69-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM); tofacitinib citrate (TOFACITINIB CITRATE); folinic acid (FOLINIC ACID), (Batch/Lot number: unknown). The patient's relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (first dose), for Covid-19 immunization. The following information was reported: DRUG INTERACTION (death, hospitalization, medically significant), outcome "fatal"; COVID-19 PNEUMONIA (death, hospitalization, medically significant), outcome "fatal", described as "COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS"; SEPTIC SHOCK (death, medically significant), outcome "fatal"; RESPIRATORY FAILURE (hospitalization), outcome "recovered", described as "acute hypoxemic respiratory failure". The patient underwent the following laboratory tests and procedures: Chest X-ray: diffuse patchy opacities; Oxygen saturation: 75 %, notes: on room air; SARS-CoV-2 test: positive. The action taken for methotrexate sodium and tofacitinib citrate was unknown. Therapeutic measures were taken as a result of drug interaction, covid-19 pneumonia, septic shock, respiratory failure. The patient date of death was unknown. Reported cause of death: "COVID-19 PNEUMONIA", "Septic shock". It was not reported if an autopsy was performed.; Sender's Comments: Based on the temporal relation, the association between the events of drug interaction, COVID-19 pneumonia, septic shock and respiratory failure and the suspect products cannot be completely ruled out. 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.; Reported Cause(s) of Death: COVID-19 PNEUMONIA; Septic shock
Sex: F
Vaccine: UNK
Symptoms: Lung opacity, Respiratory failure, SARS-CoV-2 test positive, Septic shock
Clinical narrative: drug interaction; COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS; acute hypoxemic respiratory failure; septic shock; This is a literature report for the following literature source(s):  A 69-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM); tofacitinib citrate (TOFACITINIB CITRATE); folinic acid (FOLINIC ACID), (Batch/Lot number: unknown). The patient's relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (first dose), for Covid-19 immunization. The following information was reported: DRUG INTERACTION (death, hospitalization, medically significant), outcome "fatal"; COVID-19 PNEUMONIA (death, hospitalization, medically significant), outcome "fatal", described as "COVID-19 PNEUMONIA IN A VACCINATED PATIENT WITH PSORIATIC ARTHRITIS"; SEPTIC SHOCK (death, medically significant), outcome "fatal"; RESPIRATORY FAILURE (hospitalization), outcome "recovered", described as "acute hypoxemic respiratory failure". The patient underwent the following laboratory tests and procedures: Chest X-ray: diffuse patchy opacities; Oxygen saturation: 75 %, notes: on room air; SARS-CoV-2 test: positive. The action taken for methotrexate sodium and tofacitinib citrate was unknown. Therapeutic measures were taken as a result of drug interaction, covid-19 pneumonia, septic shock, respiratory failure. The patient date of death was unknown. Reported cause of death: "COVID-19 PNEUMONIA", "Septic shock". It was not reported if an autopsy was performed.; Sender's Comments: Based on the temporal relation, the association between the events of drug interaction, COVID-19 pneumonia, septic shock and respiratory failure and the suspect products cannot be completely ruled out. 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.; Reported Cause(s) of Death: COVID-19 PNEUMONIA; Septic shock
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Food allergy, SARS-CoV-2 test
Clinical narrative: frequent dizzy spells; My blood pressure dropped to under 90/60; Many of the foods that I was eating around the time of the vaccine came back showing high sensitivities; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: IN6206), in left arm and on 18Apr2021 as dose 2, single (Lot number: EW0153) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: FOOD ALLERGY (non-serious) with onset Apr2021, outcome "not recovered", described as "Many of the foods that I was eating around the time of the vaccine came back showing high sensitivities"; BLOOD PRESSURE DECREASED (non-serious) with onset Apr2021, outcome "not recovered", described as "My blood pressure dropped to under 90/60"; DIZZINESS (non-serious) with onset Apr2021, outcome "not recovered", described as "frequent dizzy spells". The events "frequent dizzy spells", "my blood pressure dropped to under 90/60" and "many of the foods that i was eating around the time of the vaccine came back showing high sensitivities" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, blood pressure decreased, food allergy.  Additional information: Timing is only correlated. My blood pressure dropped to under 90/60. This was discovered because of frequent dizzy spells. I went to a nutritionist for the low blood pressure, and she ran a A-95 and Food Safe Extended Food Panel. Many of the foods that I was eating around the time of the vaccine came back showing high sensitivities. The patient did not receive other vaccine in four weeks. Other medications in two weeks: Daily Multivitamin. AE treatment: Food elimination diet, nutrition changes. Covid prior vaccination: No and patient was tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Interchange of vaccine products
Clinical narrative: She has been suffering with the hot flashes; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (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: moderna covid-19 vaccine (she got Moderna for the second booster shot, Dose 4 (Booster), Single), administration date: 11May2022, for Covid-19 immunization, reaction(s): "hot flashes"; Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 Booster), for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 17Oct2022, outcome "unknown"; HOT FLUSH (non-serious), outcome "unknown", described as "She has been suffering with the hot flashes".  Additional information: She has hot flashes 24/7 since the middle of Jun2022, after she received the second booster. She got Moderna for the second booster shot on 11May2022, and she started with the hot flashes since Jun2022. On 17Oct2022 she received a third booster with a Pfizer COVID 19 vaccine, but she has been suffering with the hot flashes since Jun2022.  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: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 46 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Redness of >10cm just below the injection site initiating 1day after injection and persisting. Now 3 days after injection. Redness area is warm to the touch; Redness of >10cm just below the injection site initiating 1day after injection and persisting. Now 3 days after injection. Redness area is warm to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: ATORVASTATIN; ASPIRIN 81. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 16Jan2023, outcome "not recovered", VACCINATION SITE WARMTH (non-serious) with onset 18Jan2023, outcome "not recovered" and all described as "Redness of >10cm just below the injection site initiating 1day after injection and persisting. Now 3 days after injection. Redness area is warm to the touch". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth.  Additional Information: Facility type vaccine was reported as Pharmacy or Drug Store. If other vaccine in four weeks was reported as No. Adverse event was reported as redness of >10cm just below the injection site initiating 1day after injection and persisting. Now 3 days after injection. Redness area is warm to the touch. patient had no known allergies.Since the vaccination, the patient had not been tested for COVID-19.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team and product quality group. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jan2023, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99.8, notes: Caller says he had a day or a day and a half until he took Paxlovid, he also says that he had a frontal headache, low grade fever 99.8 was the most he ever had, but once he took the Paxlovid everything seemed to normalize; (unspecified date) Low grade; SARS-CoV-2 test: (18Jan2023) Negative; (19Jan2023) Positive; (unspecified date) Positive. 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: Based on the available information in the case, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.