chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: temperature excursion with AE; No adverse event; temperature excursion with AE, vaccines were administered; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (temperature excursion with AE, vaccines were administered), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) 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. 066H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In March 2023, 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 March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (temperature excursion with AE, vaccines were administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (temperature excursion with AE, vaccines were administered), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) 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 POOR QUALITY PRODUCT ADMINISTERED (temperature excursion with AE, vaccines were administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE).    No concomitant medication were reported.  It was reported that Lost power the next day in the middle of the day at 12:00 PM. All the vaccine were placed into a frozen bag. Booster vaccines were then transported to another clinic. On 2-MAR-2023 to 28-MAR-2023 vaccines were administered to 26 patients. No reported symptoms.  No treatment information was provided by the reporter.  This case is of Patient 8 out of 26 Patients, as mentioned by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:patient no. 01 (Master case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Lost power the next day in the middle of the day at 12:00 PM.; No adverse event; Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, 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 March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  Temperature excursion occurred due to lost power in the middle of the day at 12:00 PM. Had placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. On 02-Mar-2023 to 28-Mar-2023, vaccines were administered to 26 Patients at facility. No reported symptoms.  No treatment medications was reported.  This case was reported for Patient 02 out of 26 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Lack of effect; contracted Covid in April 2022 (symptoms were mild including fatigue and loss of sense of smell, symptoms fully recovered); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (Lack of effect) and COVID-19 (contracted Covid in April 2022 (symptoms were mild including fatigue and loss of sense of smell, symptoms fully recovered)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown patient had any allergies to vaccines, medications and food.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced VACCINATION FAILURE (Lack of effect) and COVID-19 (contracted Covid in April 2022 (symptoms were mild including fatigue and loss of sense of smell, symptoms fully recovered)). At the time of the report, VACCINATION FAILURE (Lack of effect) outcome was unknown and COVID-19 (contracted Covid in April 2022 (symptoms were mild including fatigue and loss of sense of smell, symptoms fully recovered)) had resolved.            Patient year of birth was reported as 1956.  Concomitant products were not reported.  It was reported that patient received a Moderna dose contracted COVID in April 2022 (post receipt of 2nd Moderna booster shot), symptoms were mild including fatigue and loss of sense of smell, symptoms fully recovered. The event did not cause the patient to seek medical care.  Treatment medications were not reported.  Company comment: This spontaneous case report concerns a female patient of an unknown age, with no medical history provided, who experienced non serious unexpected event of COVID-19 and Vaccination failure (reported as lack of effect). Reportedly, the patient received a mRNA-1273 vaccine (stated as second booster shot) and developed COVID-19. Symptoms of COVID-19 infection were mild and included fatigue and loss of sense of smell. At the time of this report, the patient fully recovered and it was confirmed that the patient did not need medical care due to COVID-19. No additional details were provided at the moment and there was no details regarding the dates of this vaccination, as well as dates and details regarding previous COVID-19 immunisation. Case will be reassessed upon receipt of additional details. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: .
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Lost power the next day in the middle of the day at 12:00 PM.; No adverse event; Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, 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 March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  Temperature excursion occurred due to lost power in the middle of the day at 12:00 PM. Had placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. On 02-Mar-2023 to 28-Mar-2023, vaccines were administered to 26 Patients at facility. No reported symptoms.  No treatment medications was reported.  This case was reported for Patient 12 out of 26 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine went under temperature excursion; No adverse event; Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) 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. 066H22A) for COVID-19 prophylaxis.   No Medical History information was reported.    In March 2023, 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 March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) 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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion).    No concomitant medications were reported.  It was unknown patient receive any other vaccines in the 4 weeks prior to COVID-19 Vaccine.Due to Lost power the in the middle of the day at 12:00 PM, had to place all vaccine into a frozen bag. Booster vaccines were then transported to another clinic.  No treatment information was provided.  This case is of patient 22 out of 26 Patients, as mentioned by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Lost power the next day in the middle of the day at 12:00 PM.; No adverse event; Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) 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. 066H22A) 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  Temperature excursion occurred due to lost power in the middle of the day at 12:00 PM. Had placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. On 02-Mar-2023 to 28-Mar-2023, vaccines were administered to 26 Patients at facility. No reported symptoms.  No treatment medications was reported.  This case was reported for Patient 17 out of 26 patients.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Lost power the next day in the middle of the day at 12:00 PM.; No adverse event; Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, 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 March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  Temperature excursion occurred due to lost power in the middle of the day at 12:00 PM. Had placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. On 02-Mar-2023 to 28-Mar-2023, vaccines were administered to 26 Patients at facility. No reported symptoms.  No treatment medications was reported.  This case was reported for Patient 20 out of 26 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:(Patient 1)
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Patient had heart palpitations; This spontaneous case was reported by a pharmacist and describes the occurrence of PALPITATIONS (Patient had heart palpitations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Patient had heart palpitations). At the time of the report, PALPITATIONS (Patient had heart palpitations) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient went to the ER and heart palpitation was resolved. It occurred a year and a half ago.  No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine went under temperature excursion; No adverse event; Vaccine went under temperature excursion and dose was administered on 02-MAR-2023 to 28-MAR-2023; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine went under temperature excursion and dose was administered on 02-MAR-2023 to 28-MAR-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, 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 March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went under temperature excursion and dose was administered on 02-MAR-2023 to 28-MAR-2023). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine went under temperature excursion and dose was administered on 02-MAR-2023 to 28-MAR-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) 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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine went under temperature excursion and dose was administered on 02-MAR-2023 to 28-MAR-2023) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion).    No concomitant medications were reported.  It was reported that due to lost power in the middle of the day at 12:00 PM, vaccines were placed into a frozen bag. Booster vaccines were then transported to another clinic.  On 02-MAR-2023 to 28-MAR-2023 vaccines were administered to 26 patients. No symptoms were reported. No treatment information was provided.  This case was reported for patient 18 of 26 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:patient no. 01 (Master case)
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Product administered to patient of inappropriate age
Clinical narrative: 67 year old patiebt received SPIKEVAX .10mg/ml as Second dose; Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (67 year old patiebt received SPIKEVAX .10mg/ml as Second dose) in a 67-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 051F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Mar-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (67 year old patiebt received SPIKEVAX .10mg/ml as Second dose). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (67 year old patiebt received SPIKEVAX .10mg/ml as Second dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Treatment medication of the patient was not reported.  The Index number was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients; The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients), POOR QUALITY PRODUCT ADMINISTERED (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) 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. A571272B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients), POOR QUALITY PRODUCT ADMINISTERED (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients), POOR QUALITY PRODUCT ADMINISTERED (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) and POOR QUALITY PRODUCT ADMINISTERED (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients).    No concomitant medications were reported.  It was reported that 10 shots of TE vaccines were administered to patients. Highest temperature reached was 47.5 F  No treatment details were reported.   This case was linked to MOD-2023-718501 (Patient Link).
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received first dose on 8-Jul-2023 and second dose on 23-Aug-2022, post 47 days; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 8-Jul-2023 and second dose on 23-Aug-2022, post 47 days) and NO ADVERSE EVENT (No adverse event) in an 18-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 prophylaxis.     Patient did not had acute illness at the time of vaccination and up to one month before. Patient had no chronic or ling lasting health conditions.  The patient's past medical history included COVID-19 (PCR test) on 28-Jan-2022.   On 08-Jul-2022 at 9:39 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Aug-2022 at 9:23 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 23-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 8-Jul-2023 and second dose on 23-Aug-2022, post 47 days). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 8-Jul-2023 and second dose on 23-Aug-2022, post 47 days) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 8-Jul-2023 and second dose on 23-Aug-2022, post 47 days).    Concomitant medication was not provided.  Treatment information was not reported.   This case was linked to MOD-2023-713288 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and NO ADVERSE EVENT (No adverse event) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown that the patient ever been diagnosed with or tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) 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 (She had expired vaccine that was administered on March 15,2023).    No concomitant medication was provided.  Reportedly, It was unknown that either individual vials or intact cartons were used. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-Mar-2023 and the vial did not undergo any temperature excursions.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:cluster case (master case)
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; HCP stated they administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023 but the vaccine used expired on 30-MAR-2023.; 1st dose administered on 10-MAY-2022 and administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023 but the vaccine used expired on 30-MAR-2023.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 10-MAY-2022 and administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history, allergy, concomitant diseases and risk factor.    On 10-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Apr-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 03-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023 but the vaccine used expired on 30-MAR-2023.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 10-MAY-2022 and administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023 but the vaccine used expired on 30-MAR-2023.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 10-MAY-2022 and administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023 but the vaccine used expired on 30-MAR-2023.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 10-MAY-2022 and administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023).    No concomitant information was reported. It was stated that no adverse events were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Patient has not received second dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient has not received second dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient has not received second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient has not received second dose) 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 PRODUCT ADMINISTRATION INTERRUPTED (Patient has not received second dose).    No concomitant medications were provided. Patient received first Moderna vaccine on 28-Feb-2023 and she needs to get the second dose and it's their primary series. All of their vaccines expired on April 1st. Limited AE. Extended interval between primary series doses was greater than 1 month. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product administration interrupted
Clinical narrative: asked to have 2nd dose of the primary series which Moderna does not have; Product administration interrupted; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (asked to have 2nd dose of the primary series which Moderna does not have), PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (asked to have 2nd dose of the primary series which Moderna does not have), PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (no adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (asked to have 2nd dose of the primary series which Moderna does not have), PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) 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 assessments were provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (asked to have 2nd dose of the primary series which Moderna does not have) and PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted).    No concomitant medication were reported. No treatment information was provided by the reporter.
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RVX
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional.   Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable.   Further information is expected.  For reference purposes, this case is linked to MCM-004406, MCM-004408, MCM-004409 and MCM-004410 (same reporter).  SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis remains not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use.; This non-serious spontaneous safety report was received on 23-FEB-2023, from an HCP. This case is linked to case MCM-004541 (reference number 2023SA055890 and number 01495388).  Due to the nature of the event, the causality between the reported event "VAXELIS was administered to 6 patients after product experienced an excursion was not suitable to use" and Vaxelis was not applicable.  No further information is expected given that there were no adverse events following Vaxelis administration post-excursion.  For reference purposes this case is linked to MCM-004541 (source case), MCM-004562, MCM-004564, MCM-004563, and MCM-004566, due to same reporter.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, DTPPVHBHPB
Symptoms: Wrong product administered
Clinical narrative: Caller reporting a 4-month-old patient inadvertently received a dose of VAXELIS instead of the intended PREVNAR. Caller reporting the patient was supposed to receive PENTACEL and PREVNAR, and the MA accidentally administered PENTACEL and VAXELIS; Caller reporting a 4-month-old patient inadvertently received a dose of VAXELIS instead of the intended PREVNAR. Caller reporting the patient was supposed to receive PENTACEL and PREVNAR, and the MA accidentally administered PENTACEL and VAXELIS; This non-serious spontaneous safety report, with reference number 2023SA068119/ 01511126 was received by a partner on 28-FEB-2023 and forwarded on 01-MAR-2023 from a health professional.   Due to the nature of the event, the causality between the events "Caller reporting a 4-month-old patient inadvertently received a dose of VAXELIS instead of the intended PREVNAR. Caller reporting the patient was supposed to receive PENTACEL and PREVNAR, and the MA accidentally administered PENTACEL and VAXELIS" and Vaxelis was not applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Incorrect dose administered
Clinical narrative: Vaxelis was given as a 4th dose on 12/2/2022, when indicated for 3 dose series; This non-serious spontaneous safety report, with case ID 02350865/02350805 FR20220700476/FR22-04890, was received by partner, on 10MAR2023 and forwarded on 13MAR2023 from other health professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Vaxelis was given as a 4th dose on 12/2/2022, when indicated for 3 dose series".  Further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Needle issue
Clinical narrative: When putting the needle on the Prevnar 13 vial, the needle broke off at the glass neck or hub of the vial making the product defective; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 17Mar2023, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 03Mar2023 as dose 1, 0.5 ml single (Lot number: FY2475) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEEDLE ISSUE (non-serious) with onset 03Mar2023, outcome "unknown", described as "When putting the needle on the Prevnar 13 vial, the needle broke off at the glass neck or hub of the vial making the product defective". Additional information: There was actually no vaccination to a patient. When putting the needle on the Prevnar 13 vial, the needle broke off at the glass neck or hub of the vial making the product defective. The reporter was just looking at getting the product replaced.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 19:00 as dose 5 (booster), single (Lot number: GH49697) at the age of 84 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 01Sep2021 as dose 3 (booster), single (Lot number: EW0182), in left arm and on 02Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Essential tremor" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing); "IV Iodine allergy" (unspecified if ongoing); "Percocet allergy" (unspecified if ongoing). Concomitant medication(s) included: VIT B12, start date: 04Feb1995; PROPRANOLOL, start date: 21Jun2021; IRON, start date: 06Oct2021; ACCORD ANASTROZOLE, start date: 21Dec2021; AMLODIPINE, start date: 21Oct2022, stop date: 24Mar2023. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 97.7; SARS-CoV-2 test: (30Mar2023) Positive, notes: day 6; (01Apr2023) Negative, notes: day 8; (03Apr2023) Positive, notes: day 10. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Anti-viral details: Product COVID 19 Treatment, Brand: Pfizer, Treatment start date 24Mar2023, Treatment stop date 29Mar2023, Indication: Treatment of COVID-19. Other medication: Folic Acid (brand: Finest Nutrition) with start date 06Jan2023. Paxlovid last dose am 29Mar. No symptoms so far, temp 97.7 this am.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300143143 same patient, different drug, different event;
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 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 "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 21Mar2023 to 26Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300143739 same patient, different product/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 13:00 as dose 1, single (Lot number: EN6205), in right arm, on 24Mar2021 at 14:00 as dose 2, single (Lot number: EN6207), in right arm and on 07Sep2021 at 14:00 as dose 3 (booster), single (Lot number: EW0179), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Sep2022 at 13:15 as dose 4 (booster), single (Lot number: A57162B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "lung cancer" (unspecified if ongoing); "missing lower lobe of left lung" (not ongoing); "known allergies: Yes" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT HFA, start date: 04Oct1999; SINGULAIR, start date: 02May2000; VENTOLIN [SALBUTAMOL], start date: 01Dec2000; CBD OEL, start date: 14Mar2017. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022 at 13:15, outcome "not recovered"; VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid (Lot number: GF7893) from 22Mar2023 to 03Apr2023.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202300143827 same patient, different drug/events;