chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered 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.     It was unknown that patient receive 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 (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, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered 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 (Vaccine went under temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023).    No concomitant medications were provided. It was reported that due to lost power 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 symptoms were reported. No treatment medication was provided. This case contains information for the 4th out of 26 adult patients described 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
Age: 0.58
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; HCP advised that 7 month child was given the bivalent vaccine as a primary dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP advised that 7 month child was given the bivalent vaccine as a primary dose) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP advised that 7 month child was given the bivalent vaccine as a primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP advised that 7 month child was given the bivalent vaccine as a primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP advised that 7 month child was given the bivalent vaccine as a primary dose).    Concomitant medication was not reported. Patient received first dose of Moderna monovalent on 28-feb-2023.  HCP reported that, 7-month child was given the bivalent vaccine as a primary dose HCP would like to know if there are any side effect that the child may experience HCP would like to know if, and when primary dose can be administered. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Apr-2023: Live significant follow up received. Patient details, dose details and narrative was updated.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired dose of the Moderna Covid-19 vaccine was administered to 1 patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose of the Moderna Covid-19 vaccine was administered to 1 patient) and NO ADVERSE EVENT (No adverse event) 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. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Apr-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. On 02-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose of the Moderna Covid-19 vaccine was administered to 1 patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose of the Moderna Covid-19 vaccine was administered to 1 patient) 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 (Expired dose of the Moderna Covid-19 vaccine was administered to 1 patient).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  Treatment medications were not provided.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Patient had two Bivalent vaccines one in 12-Sep-2022 and the other on 03-Apr-2023; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12-Sep-2022 and the other on 03-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic.   On 12-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Apr-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12-Sep-2022 and the other on 03-Apr-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12-Sep-2022 and the other on 03-Apr-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 assessment was provided for EXTRA DOSE ADMINISTERED (Patient had two Bivalent vaccines one in 12-Sep-2022 and the other on 03-Apr-2023).    No concomitant medications were reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 27-Feb-2023 and was administered on 03-Apr-2023; No adverse event; Adult patient received expired Bivalent Moderna COVID-19 vaccine, after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine, after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 27-Feb-2023 and was administered on 03-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Apr-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. On 03-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine, after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 27-Feb-2023 and was administered on 03-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine, after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 27-Feb-2023 and was administered on 03-Apr-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 EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine, after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 27-Feb-2023 and was administered on 03-Apr-2023).    No concomitant information was reported. Suspect product dosage text was reported as additional booster. The 2.5ml vial did not underwent any temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-718357 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718357:same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: A customer got Moderna Moderna Covid-19 bivalent vaccine BUD.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A customer got Moderna Moderna Covid-19 bivalent vaccine BUD.) and NO ADVERSE EVENT (No adverse event) 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. AS7173B) 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 (A customer got Moderna Moderna Covid-19 bivalent vaccine BUD.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A customer got Moderna Moderna Covid-19 bivalent vaccine BUD.) 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 (A customer got Moderna Moderna Covid-19 bivalent vaccine BUD.).    Dosage text for suspect product was reported as additional booster. Concomitant drugs were not reported. Treatment medications were not provided.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient had received expired vaccine yesterday; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had received expired vaccine yesterday) and NO ADVERSE EVENT (No adverse event) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had received expired vaccine yesterday). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had received expired vaccine yesterday) 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 (Patient had received expired vaccine yesterday).    No concomitant medications were provided. It was reported that vaccine was expired on 6-Feb-2023 and they caught it on 03-Apr-2023 because vaccine was administered yesterday. No treatment medication was provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 04-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) 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 (Dose administered after 30-day Use By Date or after manufacturer date of expiry).    No concomitant medications was provided. No treatment medications was provided. Vial size was 5.5 mL  Date the vial was initially stored in the refrigerator was on 31Mar2023. The vial did not undergo any temperature excursions
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Depression, Feeling abnormal
Clinical narrative: depression; I felt lousy/It was annoying; I got Covid after my 2nd Moderna booster, around 15Aug2022.I had a lot of coughing, I was tired a lot; This spontaneous case was reported by a patient and describes the occurrence of DEPRESSION (depression), COVID-19 (I got Covid after my 2nd Moderna booster, around 15Aug2022.I had a lot of coughing, I was tired a lot) and FEELING ABNORMAL (I felt lousy/It was annoying) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced COVID-19 (I got Covid after my 2nd Moderna booster, around 15Aug2022.I had a lot of coughing, I was tired a lot). On an unknown date, the patient experienced DEPRESSION (depression) and FEELING ABNORMAL (I felt lousy/It was annoying). At the time of the report, DEPRESSION (depression) had resolved and COVID-19 (I got Covid after my 2nd Moderna booster, around 15Aug2022.I had a lot of coughing, I was tired a lot) and FEELING ABNORMAL (I felt lousy/It was annoying) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Immunisation reaction
Clinical narrative: Patient received again 1 dose of the Moderna monovalent vaccine; she had a stem cell transplant on Sep2022; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (she had a stem cell transplant on Sep2022) and EXTRA DOSE ADMINISTERED (Patient received again 1 dose of the Moderna monovalent vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced IMMUNISATION REACTION (she had a stem cell transplant on Sep2022). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient received again 1 dose of the Moderna monovalent vaccine). At the time of the report, IMMUNISATION REACTION (she had a stem cell transplant on Sep2022) and EXTRA DOSE ADMINISTERED (Patient received again 1 dose of the Moderna monovalent vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Chronic lymphocytic leukemia (Indolent) and Pollen allergy.    On 08-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient felt like she had a cold by the end of the week patient was fine.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Primary series vaccine expired 03/30/23 and was administered today 04/03/2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Primary series vaccine expired 03/30/23 and was administered today 04/03/2023) and NO ADVERSE EVENT (No adverse event) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Primary series vaccine expired 03/30/23 and was administered today 04/03/2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Primary series vaccine expired 03/30/23 and was administered today 04/03/2023) 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 (Primary series vaccine expired 03/30/23 and was administered today 04/03/2023).    No concomitant medication was reported.    No treatment information was reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: No adverse event; Patient received Expired vaccine of monovalent primary series on 03-Apr-2023; Vaccine expired on 01-Apr-2023, was initially stored in the refrigerator on 03-Apr-2023 and administered to patient on 03-Apr-2023; Patient received first dose on 18-Jan-2022, second dose received on 03-Apr-2023; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Expired vaccine of monovalent primary series on 03-Apr-2023), PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2023, was initially stored in the refrigerator on 03-Apr-2023 and administered to patient on 03-Apr-2023), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-Jan-2022, second dose received on 03-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 03-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Expired vaccine of monovalent primary series on 03-Apr-2023), PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2023, was initially stored in the refrigerator on 03-Apr-2023 and administered to patient on 03-Apr-2023) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-Jan-2022, second dose received 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 (Patient received Expired vaccine of monovalent primary series on 03-Apr-2023), PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2023, was initially stored in the refrigerator on 03-Apr-2023 and administered to patient on 03-Apr-2023), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-Jan-2022, second dose received 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 (Patient received Expired vaccine of monovalent primary series on 03-Apr-2023), PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2023, was initially stored in the refrigerator on 03-Apr-2023 and administered to patient on 03-Apr-2023) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 18-Jan-2022, second dose received on 03-Apr-2023).    No concomitant medications were reported.  Patient received first dose of Moderna COVID-19 Vaccine on 18-Jan-2022 (lot number 022J21A). Vial did not undergo any temperature excursions. No side effects have been reported to the HCP.  No treatment information was provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, as vial was expired on 24-MAR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, as vial was expired on 24-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 047C22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 27-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Mar-2023, after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, as vial was expired on 24-MAR-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, as vial was expired on 24-MAR-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 (Patient was accidentally administered 1 dose of Moderna COVID-19 Vaccine on 27-MAR-2023, as vial was expired on 24-MAR-2023).    No concomitant medications were reported.  No treatment information was provided.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: First Primary dose on 06JUL2022/ 2nd Primary monovalent dose on 19AUG2022; No adverse event; patient received expired first primary Monovalent Moderna COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired first primary Monovalent Moderna COVID-19 vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary dose on 06JUL2022/ 2nd Primary monovalent dose on 19AUG2022) and NO ADVERSE EVENT (No adverse event) in a 20-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 055A22A and 027L21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Aug-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired first primary Monovalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary dose on 06JUL2022/ 2nd Primary monovalent dose on 19AUG2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired first primary Monovalent Moderna COVID-19 vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary dose on 06JUL2022/ 2nd Primary monovalent dose on 19AUG2022) 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 (patient received expired first primary Monovalent Moderna COVID-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary dose on 06JUL2022/ 2nd Primary monovalent dose on 19AUG2022).    No concomitant medication details was reported. Intact cartons was used and vial size was 2.5ml. The vial was initially stored in the refrigerator on 06-JUL-2022. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: redness has gone down near the elbow/ the upper part is not as red but the bottom part is still red; redness has gone down near the elbow/ the upper part is not as red but the bottom part is still red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 96-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "redness has gone down near the elbow/ the upper part is not as red but the bottom part is still red". Therapeutic measures were taken as a result of erythema, pruritus. Additional information: Patient was given penicillin.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Secondary immunodeficiency
Clinical narrative: Tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization. The following information was reported: SECONDARY IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "Tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines". The patient underwent the following laboratory tests and procedures: Secondary immune deficiencies: Positive, notes: 3 patients have tested positive for secondary immune deficiencies. Therapeutic measures were taken as a result of secondary immunodeficiency. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Clinical course: It was reported 3 patients have tested positive for secondary immune deficiencies after completing the series of 3 Pfizer COVID vaccines. All have been diagnosed and started on IVIG. patients were not treated with any biologics prior to testing positive for secondary immune deficiency.; Sender's Comments: Based on available information, a possible contributory role of the subject product BNT162B2 vaccine cannot be excluded for the reported event of secondary immune deficiencies due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including serum immunoglobulin levels at baseline and post vaccination, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202300141697 same reporter/drug/event, diff patients;US-PFIZER INC-PV202300061072 same reporter/drug/event, diff patients;
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna: 17Aug2021; 14Sep2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EM9810), in left arm, on 25Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 14Jan2022 as dose 5 (booster), single (Lot number: Fj6369) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Aug2021 as dose 3 (booster), single (Lot number: 939902), in left arm and on 14Sep2021 as dose 4 (booster), single (Lot number: 058E21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "A-Fib" (unspecified if ongoing); "Prostate cancer" (unspecified if ongoing). Concomitant medication(s) included: TIKOSYN, start date: Nov2021. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Aug2021, outcome "unknown", described as "Moderna: 17Aug2021; 14Sep2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19 screening, Influenza A virus test, Influenza B virus test, Pharyngeal erythema
Clinical narrative: Vomiting; High Fever; Throat is Red; This is a spontaneous report received from contactable reporter (Other HCP).  A 3-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 29Mar2023 at 15:30 as dose 1 (maroon cap), 0.2 ml single (Lot number: FX5095, Expiration Date: 31Jul2023) at the age of 3 years intramuscular, in right leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PHARYNGEAL ERYTHEMA (non-serious) with onset 29Mar2023, outcome "not recovered", described as "Throat is Red"; PYREXIA (non-serious) with onset 29Mar2023 at 18:00, outcome "not recovered", described as "High Fever"; VOMITING (non-serious) with onset 29Mar2023 at 18:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vomiting, pyrexia, pharyngeal erythema.  Additional information: Caller was calling about the Pfizer Covid 19 Vaccine Monovalent for Ages 6mo-4years. Caller stated she had a patient who received a Covid Vaccine for the first time and he was 3 years old. The patient was having vomiting and high fever. Prior to coming in for the vaccine, his Mom and Dad said he was completely fine and healthy. The vaccine was administered at 3:30 p.m. on Wednesday (29Mar2023) and by 6:00 p.m. that night he was running a high fever and vomiting. Caller stated she tested him for Covid, Influenza A and B and those were all negative. The patient's throat was red, which she believed was due to vomiting but she also testing him for strep throat, and that was also negative. Caller asking would this be concerning for a 3-year-old to have that reaction within 3 hours and it was now Friday (31Mar2023) and it was still persisting and this happened on Wednesday. Reporter seriousness for events: Not serious. Relatedness of drug to events was assessed as yes by primary source reporter per global introspection. Treatment: Paracetamol (TYLENOL), ibuprofen (MOTRIN), ondansetron (ZOFRAN).
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Streptococcus test, Vomiting
Clinical narrative: Vomiting; High Fever; Throat is Red; This is a spontaneous report received from contactable reporter (Other HCP).  A 3-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 29Mar2023 at 15:30 as dose 1 (maroon cap), 0.2 ml single (Lot number: FX5095, Expiration Date: 31Jul2023) at the age of 3 years intramuscular, in right leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PHARYNGEAL ERYTHEMA (non-serious) with onset 29Mar2023, outcome "not recovered", described as "Throat is Red"; PYREXIA (non-serious) with onset 29Mar2023 at 18:00, outcome "not recovered", described as "High Fever"; VOMITING (non-serious) with onset 29Mar2023 at 18:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vomiting, pyrexia, pharyngeal erythema.  Additional information: Caller was calling about the Pfizer Covid 19 Vaccine Monovalent for Ages 6mo-4years. Caller stated she had a patient who received a Covid Vaccine for the first time and he was 3 years old. The patient was having vomiting and high fever. Prior to coming in for the vaccine, his Mom and Dad said he was completely fine and healthy. The vaccine was administered at 3:30 p.m. on Wednesday (29Mar2023) and by 6:00 p.m. that night he was running a high fever and vomiting. Caller stated she tested him for Covid, Influenza A and B and those were all negative. The patient's throat was red, which she believed was due to vomiting but she also testing him for strep throat, and that was also negative. Caller asking would this be concerning for a 3-year-old to have that reaction within 3 hours and it was now Friday (31Mar2023) and it was still persisting and this happened on Wednesday. Reporter seriousness for events: Not serious. Relatedness of drug to events was assessed as yes by primary source reporter per global introspection. Treatment: Paracetamol (TYLENOL), ibuprofen (MOTRIN), ondansetron (ZOFRAN).
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Migraine with aura
Clinical narrative: I got the booster in the Apr2022, that was almost an years ago, I still have a migraine headache from it; it messed up my right eye busted the background of my eye now I am seeing like feathers in my eye/migraine with aura; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Oct2021, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), administration date: Nov2021, for COVID-19 immunisation. The following information was reported: MIGRAINE (non-serious), outcome "not recovered", described as "I got the booster in the Apr2022, that was almost an years ago, I still have a migraine headache from it"; MIGRAINE WITH AURA (non-serious), outcome "not recovered", described as "it messed up my right eye busted the background of my eye now I am seeing like feathers in my eye/migraine with aura".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective/Treatment of COVID-19; COVID-19/Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Hiatal hernia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Drug allergy"; Zofran, reaction(s): "Drug allergy"; Phenegran, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Drug ineffective/Treatment of COVID-19"; COVID-19 (medically significant), outcome "not recovered", described as "COVID-19/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: testing positive beginning 2.5 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received no other medication in 2 weeks at the time of reporting. The patient was treated with Paxlovid (Batch/Lot number: GF1750) from 24Mar2023 to 28Apr2023.   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-202300141795 same patient, different drug/events;
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "known allergies: Tetracycline", notes: known allergies: Tetracycline; Zithromax, reaction(s): "known allergies: Zithromax", notes: known allergies: Zithromax; Iodine, reaction(s): "known allergies: Iodine", notes: known allergies: Iodine; Feldene, reaction(s): "known allergies: Feldene", notes: known allergies: Feldene. 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: Patient has vaccine received and also received other medication in 2weeks. Patient has received Paxlovid as treatment medication.  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: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 as dose 5 (booster), single (Lot number: GJ6738) at the age of 39 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 had no relevant medical history.  No known allergies . There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EK9231), in left arm, on 26Sep2021 as dose 2, single (Lot number: 30135BA), in left arm, on 21Dec2021 as dose 3 (booster), single (Lot number: EK5730), in left arm and on 09Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 24Mar2023, outcome "recovered", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 24Mar2023, outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Mar2023) Positive; (30Mar2023) Negative; (31Mar2023) Negative. 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 information currently available, there is a reasonable possibility of a causal  association between the reported adverse events drug ineffective, Covid-19 and the suspect  product  BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5).,Linked Report(s) : US-PFIZER INC-202300142924 same reporter/patient, different product/AE;US-PFIZER INC-202300143007 Same reporter/patient, same drug/different dose, different AE;