chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 07Sep2022, 2nd 10Jan2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 7th September 2022).   On 10-JAN-2023, the patient received the 2nd dose of Twinrix. On 10-JAN-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 07Sep2022, 2nd 10Jan2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 26-APR-2023 The pharmacist reported that an adult patient received standard Twinrix second dose late.  The reporter declined to provide more information. The reporter did not consent to follow up. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: BLOODY DIARRHEA; This spontaneous report received from a consumer via a company representative concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. Age at time of vaccination 6 decade old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, 2 days after receiving the first dose of vaccine, the patient was admitted for bloody diarrhea. The number of days of hospitalization were not reported. It was unknown if patient was discharged or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bloody diarrhea was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20230459184-Bloody diarrhea-The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Vomiting
Clinical narrative: get the terrible like extremally headache worse then anything I know I used to have it; At about 36 hours I was not able to keep anything down and then I spent whole day l ke vomiting; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (get the terrible like extremally headache worse then anything I know I used to have it) and VOMITING (At about 36 hours I was not able to keep anything down and then I spent whole day l ke vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product FAMTOZINAMERAN, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5)) for an unknown indication.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of FAMTOZINAMERAN, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (get the terrible like extremally headache worse then anything I know I used to have it) and VOMITING (At about 36 hours I was not able to keep anything down and then I spent whole day l ke vomiting). At the time of the report, HEADACHE (get the terrible like extremally headache worse then anything I know I used to have it) and VOMITING (At about 36 hours I was not able to keep anything down and then I spent whole day l ke vomiting) outcome was unknown.            Concomitant medications were not reported.  Patient had the initial series in 2021 got Modema and had absolutely terrible time with the second Modema shot (Unspecified Shot) and patient didn't get booster until now . Patient was told that Pfizer has a lower  dose so tried that. Patient had exactly same of course which previously had with Moderna and was slightly milder. But it was still really awful. So, patient was like most people who got no symptoms and discomfort for about a day and they are okay, patient had three days of hell. About 36 hours were really bad for patient.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721461 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721461:
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient was administered with Monovalent vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered with Monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered with Monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered with Monovalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was administered with Monovalent vaccine).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721452, US-MODERNATX, INC.-MOD-2023-721454 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721452:Same reporter US-MODERNATX, INC.-MOD-2023-721454:Same reporter
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. OSIB22A, 011J20A, 011J20A and 011CZIA) for COVID-19 prophylaxis.     The patient had no allergies. The patient had no acute illnesses at the time of vaccination and up to one month before.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Dec-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2022, SARS-CoV-2 test: Positive.         Concomitant product use was not provided by the reporter. Patient height was reported as 6 and weight was 247 (Units Unknown). The patient had not received prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination and/or at the time of the adverse event.  No treatment information was provided   This case was linked to MOD-2023-719642 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Apr-2023, the patient experienced COVID-19 (Tested positive for Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 25-Apr-2023 at a dose of 150mg/100mg dose pack in blister packs, taken once. At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2023, SARS-CoV-2 test: (Positive) culture source was nose swab.         Concomitant medication was not reported.  Patient received all vaccines from Moderna. First dose on 15-JAN-2021 in early evening about 17:30 (lot: 025L20A, expiration: Unknown). Second dose on 12-FEB-2021 in late morning (lot: 010M20A, expiration: unknown). Third dose on 15-OCT-2021 like about 13:30 (lot: 027C71A, expiration: Unknown). Fourth dose on 01-JUN-2022 in morning (lot: 025L2113, expiration: unknown). Patient received fifth dose in early afternoon.   Patient had all vaccinations and all of boosters and still got COVID. Patient started taking Paxlovid on 25-Apr-2023. Patient had a yucky taste in mouth, began right after took first dose of Paxlovid, immediately happened within 15 minutes. Took first dose of Paxlovid at 11:30. Expiry Date of Paxlovid was on an unknown date in Apr-2023. Patient had not visited Emergency Room or Physician Office.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 12-Mar-2023 and was administered to patient on 21-Apr-2023; No adverse event; Patient was accidentally administered with Moderna COVID-19 Vaccine beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered with Moderna COVID-19 Vaccine beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 12-Mar-2023 and was administered to patient on 21-Apr-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. 016H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 21-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 21-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered with Moderna COVID-19 Vaccine beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 12-Mar-2023 and was administered to patient on 21-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered with Moderna COVID-19 Vaccine beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 12-Mar-2023 and was administered to patient on 21-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 (Patient was accidentally administered with Moderna COVID-19 Vaccine beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 12-Mar-2023 and was administered to patient on 21-Apr-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that the reporter was not aware if patient experienced any adverse events. Treatment medications were not provided.  This case was reported for patient 2 of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-721680 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721680:1st patient case (Master case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; they were administering the 2nd dose to this age group from the vial with the pink cap. Today, 27Apr2023, there were 3 babies all below one year old who were given that; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (they were administering the 2nd dose to this age group from the vial with the pink cap. Today, 27Apr2023, there were 3 babies all below one year old who were given that) and NO ADVERSE EVENT (no adverse event) in an infant 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-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) .2 milliliter. On 27-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (they were administering the 2nd dose to this age group from the vial with the pink cap. Today, 27Apr2023, there were 3 babies all below one year old who were given that). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (they were administering the 2nd dose to this age group from the vial with the pink cap. Today, 27Apr2023, there were 3 babies all below one year old who were given that) 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 (they were administering the 2nd dose to this age group from the vial with the pink cap. Today, 27Apr2023, there were 3 babies all below one year old who were given that).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721697, US-MODERNATX, INC.-MOD-2023-721696 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721697: US-MODERNATX, INC.-MOD-2023-721696:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.) and NO ADVERSE EVENT (No adverse event) in an infant 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-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) .2 milliliter. On 27-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.) 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 (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.).    No concomitant information was reported. This case is reported for patient 2 out of 3 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721695 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721695:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.) and NO ADVERSE EVENT (No adverse event) in an infant 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-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) .2 milliliter. On 27-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.) 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 (They were administering the 2nd dose to this age group from the vial with the pink cap.Today, 27-Apr-2023, baby was below one year old who was given that.).    No concomitant information was reported. This case is reported for patient 3 out of 3 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721695 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721695:(Master Document) (Patient no -1)
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: For the second dose Moderna bivalent vaccines has been administered, as we had to discard all of our monovalent COVID vaccines; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (For the second dose Moderna bivalent vaccines has been administered, as we had to discard all of our monovalent COVID vaccines) and NO ADVERSE EVENT (No adverse event) in a 6-month-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.     Previously administered products included for Product used for unknown indication: Pfizer monovalent COVID Vaccine (22 days ago and First dose). Past adverse reactions to the above products included No adverse effect with Pfizer monovalent COVID Vaccine.    On an unknown date, 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 an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (For the second dose Moderna bivalent vaccines has been administered, as we had to discard all of our monovalent COVID vaccines) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (For the second dose Moderna bivalent vaccines has been administered, as we had to discard all of our monovalent COVID vaccines) 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 (For the second dose Moderna bivalent vaccines has been administered, as we had to discard all of our monovalent COVID vaccines).    Concomitant medication was not provided.  It was reported that the patient was taken to clinic for the second dose, but due to discard of all monovalent COVID vaccines from the clinic and as the clinic had only Moderna bivalent vaccines; the medical assistant administered the Moderna bivalent vaccine to the patient without checking what the previous dose was.  It was also reported that mother of the patient was understandably upset.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The batch was administered to 6 patients after 12-Jan-2023, last dose given was 13-Apr-2023; Vial was expired 30 days after being in the fridge; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The batch was administered to 6 patients after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The batch was administered to 6 patients after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The batch was administered to 6 patients after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The batch was administered to 6 patients after 12-Jan-2023, last dose given was 13-Apr-2023) and PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge).    No concomitant medications was reported. It was reported that Moderna Covid-19 vaccine monovalent 6months-5 years was delivered to on 12-Dec-2022 and they have had them in the refrigerator since. They state that it is their understanding that it expires 30 days after being in the fridge, but they were getting notices from the department of health that the expiration date of the said batch were extended, the last one they received said that expiration date was 14-May-2023. The batch was administered to 6 patients after 12-Jan-2023, last dose given was 13-Apr-2023. No treatment drug details was reported. This case contains 2nd patient out of 6 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721723 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721723:1st patient case (Master case)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.; The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.), PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.), PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.), PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.) and PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that the Moderna Covid-19 vaccine monovalent 6months-5 years which was delivered on 12-Dec-2022 was administered to patients after 12-Jan-2023 with last dose given on 13-Apr-2023.  Treatment medications were not provided.  This case was reported for patient 6 of 6.   This case was linked to US-MODERNATX, INC.-MOD-2023-721723 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721723:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.; The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.), PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.), PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.), PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.) and PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that the Moderna Covid-19 vaccine monovalent 6months-5 years which was delivered on 12-Dec-2022 was administered to patients after 12-Jan-2023 with last dose given on 13-Apr-2023.  Treatment medications were not provided.  This case was reported for patient 4 of 6.   This case was linked to US-MODERNATX, INC.-MOD-2023-721723 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721723:01 patient case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023; Vial was expired 30 days after being in the fridge; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023) and PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge).    No concomitant medications were reported.  The vaccine was delivered on 12-Dec-2022 and they have had them in the refrigerator since. The reporter stated that it was their understanding that it expires 30 days after being in the fridge but they were getting notices from the department of health that the expiration date of the said batch were extended, the last one they received said that expiration date was 14-May-2023. The batch was administered to 6 patients after 12-Jan-2023, last dose was given on 13-Apr-2023.  No treatment medications were reported.  This case contains information for the 3 of 6th child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721723 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721723:1st patient case (Master case)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023; Vial was expired 30 days after being in the fridge; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023), PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023) and PRODUCT STORAGE ERROR (Vial was expired 30 days after being in the fridge).    No concomitant medications were reported.  The vaccine was delivered on 12-Dec-2022 and they have had them in the refrigerator since. The reporter stated that it was their understanding that it expires 30 days after being in the fridge but they were getting notices from the department of health that the expiration date of the said batch were extended, the last one they received said that expiration date was 14-May-2023. The batch was administered to 6 patients after 12-Jan-2023, last dose was given on 13-Apr-2023.  No treatment medications were reported.  This case contains information for the 5 of 6th child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721723 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721723:05th patient case
Age: 1.92
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Immunisation reaction, Interchange of vaccine products
Clinical narrative: Potential AE; first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.; first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Potential AE), INTERCHANGE OF VACCINE PRODUCTS (first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.) and COVID-19 IMMUNISATION (first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.) in a 23-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 21-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2023, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Feb-2023, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.) and COVID-19 IMMUNISATION (first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.). On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE). At the time of the report, IMMUNISATION REACTION (Potential AE), INTERCHANGE OF VACCINE PRODUCTS (first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.) and COVID-19 IMMUNISATION (first COVID-19 vaccine dose on 12/21/22 with Moderna's formulation, then received a second COVID19 vaccine dose with Pfizer's formulation on 2/24/23.) outcome was unknown.        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. No treatment medications were reported.
Age: 0.58
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; A first dose of Moderna Covid-19 vaccine was given on 21-Apr-2023 from a booster dose vial with a pink cap yellow border.; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (A first dose of Moderna Covid-19 vaccine was given on 21-Apr-2023 from a booster dose vial with a pink cap yellow border.) 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. 216K22A) for COVID-19 prophylaxis.     The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Influenza vaccine on 21-Apr-2022. Past adverse reactions to the above products included No adverse event with Influenza vaccine.    On 21-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (A first dose of Moderna Covid-19 vaccine was given on 21-Apr-2023 from a booster dose vial with a pink cap yellow border.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A first dose of Moderna Covid-19 vaccine was given on 21-Apr-2023 from a booster dose vial with a pink cap yellow border.) 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 (A first dose of Moderna Covid-19 vaccine was given on 21-Apr-2023 from a booster dose vial with a pink cap yellow border.).    No concomitant information was reported. It was reported that no other adverse reactions reported . No treatment information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, Feeling abnormal, Pain
Clinical narrative: she felt miserable; achy all over her body; Patient received  second bivalent Moderna on 26-Apr-2023; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (she felt miserable), PAIN (achy all over her body) and EXTRA DOSE ADMINISTERED (Patient received  second bivalent Moderna on 26-Apr-2023) in an 84-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 045H22A and 041H22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose , EK9231) on 31-Jan-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose ,EL3302) on 17-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (3rd dose ,303388A) on 29-Aug-2021, PFIZER BIONTECH COVID-19 VACCINE (4th dose andFP4554) on 30-Mar-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Blood pressure high (taking meds for high blood pressure).   On 07-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Apr-2023, received sixth 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 26-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 received  second bivalent Moderna on 26-Apr-2023). On 27-Apr-2023, the patient experienced FEELING ABNORMAL (she felt miserable) and PAIN (achy all over her body). The patient was treated with PARACETAMOL (TYLENOL) for Feeling miserable and General body pain, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (she felt miserable), PAIN (achy all over her body) and EXTRA DOSE ADMINISTERED (Patient received  second bivalent Moderna on 26-Apr-2023) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that patient did not get sick after getting the all of the vaccines except for the last bivalent Moderna dose.
Age: 0.83
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: The patient never received the 2nd Monovalent dose.; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (The patient never received the 2nd Monovalent dose.) and NO ADVERSE EVENT (No Adverse Event) in a 10-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (The patient never received the 2nd Monovalent dose.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (The patient never received the 2nd Monovalent dose.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (The patient never received the 2nd Monovalent dose.).    No concomitant medication details was reported. No treatment medication details was reported.