chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling hot, Hyperhidrosis
Clinical narrative: The funny thing was she was perspiring only on the left side of the body; she got the Moderna bivalent on Tuesday. Her arm was still hot. It was little hot. It was going down.; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (she got the Moderna bivalent on Tuesday. Her arm was still hot. It was little hot. It was going down.) and HYPERHIDROSIS (The funny thing was she was perspiring only on the left side of the body) in a 77-year-old female patient 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 06-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 06-Jun-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 06-Jun-2023, the patient experienced FEELING HOT (she got the Moderna bivalent on Tuesday. Her arm was still hot. It was little hot. It was going down.). On an unknown date, the patient experienced HYPERHIDROSIS (The funny thing was she was perspiring only on the left side of the body). At the time of the report, FEELING HOT (she got the Moderna bivalent on Tuesday. Her arm was still hot. It was little hot. It was going down.) and HYPERHIDROSIS (The funny thing was she was perspiring only on the left side of the body) had not resolved.            It was reported that patient did not received any other vaccine in the 4 weeks prior to Covid-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that patient was wondering if that's an unusual reaction. She was getting worried. It did not bother her. It was just a point of concern.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728662 (E2B Linked Report). This case was linked to MOD-2023-728662 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728662:Monovalent dose case
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Lethargy, Pyrexia
Clinical narrative: fever; headache; felt lethargic; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and LETHARGY (felt lethargic) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL, SIMVASTATIN, APIXABAN (ELIQUIS) and AMLODIPINE for an unknown indication.   On 08-Sep-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 01-Jun-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. In June 2023, the patient experienced PYREXIA (fever), HEADACHE (headache) and LETHARGY (felt lethargic). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), HEADACHE (headache) and LETHARGY (felt lethargic) had not resolved.        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.   It was reported that the did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine The patient had COVID-19 diagnosis. The patient had received the 1st dose of COVID-19 Vaccine on 12-JAN-2021, 2nd dose on 11-FEB-2021, 3rd dose on 18-AUG-2021 and the 4th dose on 05-APR-2022. The patient experienced these same symptoms with 1st dose which lasted for 3 or 4 days, and with last dose symptoms occurred approximately 1 week after the injection as the patient  had a delayed reaction, and symptoms were still ongoing.   This case was linked to US-MODERNATX, INC.-MOD-2023-728880 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728880:(Monovalent Case)
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pyrexia
Clinical narrative: felt lethargic; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt lethargic), PYREXIA (Fever) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No COVID-19 diagnosis was reported.  Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL, SIMVASTATIN, APIXABAN (ELIQUIS) and AMLODIPINE for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LETHARGY (felt lethargic), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, LETHARGY (felt lethargic), PYREXIA (Fever) and HEADACHE (Headache) had resolved.            Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that fever, headache and she felt lethargic, with 1st dose this lasted 3 or 4 days.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728878 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728878:(Bivalent Case)
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received 1st dose of Moderna vaccine on 3-Feb-2021 and second dose of Moderna on 7-Nov-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose of Moderna vaccine on 3-Feb-2021 and second dose of Moderna on 7-Nov-2021) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose of Moderna vaccine on 3-Feb-2021 and second dose of Moderna on 7-Nov-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose of Moderna vaccine on 3-Feb-2021 and second dose of Moderna on 7-Nov-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose of Moderna vaccine on 3-Feb-2021 and second dose of Moderna on 7-Nov-2021).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728660 (E2B Linked Report). This case was linked to MOD-2023-728660 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Tremor
Clinical narrative: flu like"symptoms; flu -body shakes / Tremoring would be more like chilling; tremoring with cold sensations/Tremoring would be more like chilling; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like"symptoms), TREMOR (flu -body shakes / Tremoring would be more like chilling) and CHILLS (tremoring with cold sensations/Tremoring would be more like chilling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like"symptoms), TREMOR (flu -body shakes / Tremoring would be more like chilling) and CHILLS (tremoring with cold sensations/Tremoring would be more like chilling). At the time of the report, INFLUENZA LIKE ILLNESS (flu like"symptoms), TREMOR (flu -body shakes / Tremoring would be more like chilling) and CHILLS (tremoring with cold sensations/Tremoring would be more like chilling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It was reported patient had the minimum compulsory required Covid-19 shots at the end of 2020.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 doses of the bivalent vaccine which expired on 06Jun2023 were administered 1 dose on 06/07/2023 & 4 doses on 06/08/2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses of the bivalent vaccine which expired on 06Jun2023 were administered 1 dose on 06/07/2023 & 4 doses on 06/08/2023) 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. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jun-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 07-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses of the bivalent vaccine which expired on 06Jun2023 were administered 1 dose on 06/07/2023 & 4 doses on 06/08/2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses of the bivalent vaccine which expired on 06Jun2023 were administered 1 dose on 06/07/2023 & 4 doses on 06/08/2023) 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 EXPIRED PRODUCT ADMINISTERED (5 doses of the bivalent vaccine which expired on 06Jun2023 were administered 1 dose on 06/07/2023 & 4 doses on 06/08/2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  Pharmacist stated that perhaps 5 doses of the bivalent vaccine which was expired on 06-Jun-2023 were administered.  Vial size was reported as 2.5ML.  Date the vial was initially stored in the refrigerator was 06/07/2023.  Dates of administration of vaccine was reported as 1 dose on 06/07/2023 and 4 doses on 06/08/2023.   The vial had not undergone any temperature excursions.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-729018, US-MODERNATX, INC.-MOD-2023-729029, US-MODERNATX, INC.-MOD-2023-729022, US-MODERNATX, INC.-MOD-2023-729027 (Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2023: Follow up received is significant. Report type is getting upgraded from invalid to spontaneous. Dose start date was updated, Event start date was updated and Narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729018:dose 2 of 5 US-MODERNATX, INC.-MOD-2023-729029:dose 5 of 5 US-MODERNATX, INC.-MOD-2023-729022:dose 3 of 5 US-MODERNATX, INC.-MOD-2023-729027:dose 4 of 5
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 02-Jun-2023, first punctured on 08-Jun-2023 and was administered with 09-Jun-2023; No adverse event; Patient was administered with vaccine >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine >12 hours post puncture), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Jun-2023, first punctured on 08-Jun-2023 and was administered with 09-Jun-2023) 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)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jun-2023 at 3:48 PM, 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 09-Jun-2023 at 3:48 PM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine >12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Jun-2023, first punctured on 08-Jun-2023 and was administered with 09-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine >12 hours post puncture), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Jun-2023, first punctured on 08-Jun-2023 and was administered with 09-Jun-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 administered with vaccine >12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 02-Jun-2023, first punctured on 08-Jun-2023 and was administered with 09-Jun-2023).    No concomitant medications were provided. The vial size was 2.5ml. The vial was initially stored in the refrigerator on 02-Jun-2023 from the freezer and taken out of the fridge on 08-Jun-2023. The vial was first punctured on 08-Jun-2023 at 1:44 PM. The vial was stored post puncture at room temperature. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 26hs and 30 minutes. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728739 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728739:Same reporter
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Nurse stated that doses were given in their facility >12(US) hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse stated that doses were given in their facility >12(US) hours post puncture) 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)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jun-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 09-Jun-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 (Nurse stated that doses were given in their facility >12(US) hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse stated that doses were given in their facility >12(US) hours post puncture) 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 (Nurse stated that doses were given in their facility >12(US) hours post puncture).    Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator on 01-JUN-2023. Vial size was reported as 2.5 ml. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 26hs and 30 minutes. The vial exposed to room temperature for >24 hour 09-Jun-2023. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728775 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728775:Same reporter
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; dose administered today was after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered today was after the published expiration date) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax (4 doses monovalent and 2 doses bivalent). Past adverse reactions to the above products included No adverse event with Spikevax.    On 09-Jun-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered today was after the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered today was after the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (dose administered today was after the published expiration date).    No concomitant medication was reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: a moderna vaccine given on the 8th to a patient and the vaccine expired on the 5th; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a moderna vaccine given on the 8th to a patient and the vaccine expired on the 5th) and NO ADVERSE EVENT (No adverse event) in an elderly 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. 023H22A) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (a moderna vaccine given on the 8th to a patient and the vaccine expired on the 5th) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a moderna vaccine given on the 8th to a patient and the vaccine expired on the 5th) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (a moderna vaccine given on the 8th to a patient and the vaccine expired on the 5th).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that one of the patient was immunocompromised. No treatment information was provided.
Age: 0.5
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Nurse is calling to report that patient received expired vaccine on 12-JUN-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-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 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-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 EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023).    No concomitant information was reported. Suspect product dosage text was reported as unknown. The 2.5ml vial was initially stored in refrigerator on 09-Jun-2023 and did not underwent temperature excursions.  This case is reported for 6 month old baby. No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; she has a patient that received a moderna bivalent vaccinet that expired on June 9th; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (she has a patient that received a moderna bivalent vaccinet that expired on June 9th) 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. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-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 13-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (she has a patient that received a moderna bivalent vaccinet that expired on June 9th). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (she has a patient that received a moderna bivalent vaccinet that expired on June 9th) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient received the vaccine this morning around 9:00 am. Expiry date of the vaccine was reported as 09-Jun-2023.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered an expired vaccine; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired vaccine) and NO ADVERSE EVENT (no adverse event) in a 57-year-old 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. 041h22a) 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 (patient was administered an expired vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient was administered an expired vaccine).    No concomitant medication was reported. Dosage text for suspect product was reported as unknown. Expiry date of the suspect vaccine was reported as 07-JUN-2023. No treatment medication was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was expired on 07-JUN-2023 and stored in refrigerator on 13-JUN-2023; No adverse event; Dose administered after Manufacturer Date of Expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vaccine was expired on 07-JUN-2023 and stored in refrigerator on 13-JUN-2023) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1), Moderna COVID-19 vaccine (Dose 3) and Moderna COVID-19 vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 13-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jun-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 (Dose administered after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 07-JUN-2023 and stored in refrigerator on 13-JUN-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vaccine was expired on 07-JUN-2023 and stored in refrigerator on 13-JUN-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 (Dose administered after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Vaccine was expired on 07-JUN-2023 and stored in refrigerator on 13-JUN-2023).    Patient received all Moderna vaccines and have never had any problems with the vaccines. Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator was on 13-JUN-2023.  Vial size was reported as 0.5 ml. Vial did not undergo any temperature excursion. NDC number was reported as 8077728205. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Paxlovid COVID 19 Treatment; Paxlovid COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; 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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: 6201), in right arm, on 25Mar2021 as dose 2, single (Lot number: en6200), in right arm and on 19Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03May2022 as dose 4 (booster), single (Lot number: O49L21A), in right arm and on 10Oct2022 as dose 5 (booster), single (Lot number: A57163B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancers that have been removed" (unspecified if ongoing); "Skin cancers that have been removed" (unspecified if ongoing); "Known allergies: anaphylactic allergy to peanuts" (unspecified if ongoing); "Known allergies: tree nuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03May2022, outcome "not recovered", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: dizzy; had numbness in my feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization; Bnt162b2 (Dose 2, Single), for COVID-19 immunization; Bnt162b2 (Dose 3, (Booster) Single), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "recovering", described as "dizzy"; HYPOAESTHESIA (non-serious), outcome "recovering", described as "had numbness in my feet".  Additional information: After the second booster I got Covid. Then I started being dizzy and had numbness in my feet. Those symptoms eventually decreased.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300104567 same reporter/patient, different dose/event;US-PFIZER INC-202300220101 same reporter/patient, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Impaired driving ability
Clinical narrative: dizzy; had numbness in my feet; the dizziness prevents me from driving; total fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, After the second booster I got Covid. Then I started being dizzy, and had numbness in my feet), for Covid-19 immunization, reaction(s): "dizzy", "numbness in my feet". The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "dizzy"; HYPOAESTHESIA (non-serious), outcome "recovered", described as "had numbness in my feet"; IMPAIRED DRIVING ABILITY (non-serious), outcome "recovered", described as "the dizziness prevents me from driving"; FATIGUE (non-serious), outcome "recovered", described as "total fatigue".  Additional information: Patient reported that all of vaccines are Pfizer two Covid and three boosters. After the second booster patient got Covid. Then the patient started being dizzy and had numbness in patient feet. Those symptoms eventually decreased. Then the patient got the third booster and the symptoms came back and never went away. There are days that the dizziness prevents patient from driving. Also, days of total fatigue.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300220100 same reporter/patient, different dose/event;US-PFIZER INC-PV202300104567 same reporter/patient, different dose/event;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on left side of face. closest to eye; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20May2023 at 11:00 as dose 4 (booster), single (Lot number: GJ8930) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sunflower seeds" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: 32030bd, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 02Feb2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: er8729, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 16Mar2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: f87138, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 25Aug2022, when the patient was 63-year-old, for COVID-19 immunization; flu (Vaccine Location: Right arm), administration date: 25Aug2022, when the patient was 63-year-old, for Immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Numbness on left side of face. closest to eye". The event "numbness on left side of face. closest to eye" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of hypoaesthesia.  Additional information: the patient had no Covid prior vaccination, and no Covid tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Lower lip broke out with five large cold sores which is the herpes simplex; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Primary Immunization series complete), for COVID-19 immunisation. The following information was reported: ORAL HERPES (non-serious), outcome "unknown", described as "Lower lip broke out with five large cold sores which is the herpes simplex". Additional information: The patient has gotten all of her vaccines from Moderna and she is 74 years old. She stated that when the bivalent vaccine came out she got the Pfizer bivalent and less than 24 hours her lower lip broke out with five large cold sores which is the herpes simplex. She wants to know if she can get another bivalent vaccine or not or if she should go back with Moderna. She mentioned that her primary care physician told her to not get another COVID-19 vaccine for fear of anaphylactic shock.   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: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood albumin, Blood alkaline phosphatase, Blood bilirubin
Clinical narrative: Caller says the patient last got 2 moderna doses back on 2021; Expiration on the vial itself shows Sep2022/administration date: 13Jun2023; it was first punctured yesterday at 4pm but was still given today at 3:20PM; it was first punctured yesterday at 4pm but was still given today at 3:20PM; Creatinine: 10.2; CO2: 22; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: ().  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jun2023 at 15:20 as dose 3 (booster), 0.3 ml single (Lot number: GL2042, Expiration Date: Sep2022) at the age of 54 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AZOR [AMLODIPINE BESILATE;OLMESARTAN MEDOXOMIL]; XIGDUO XR; METFORMIN [METFORMIN HYDROCHLORIDE]; PRILOSEC [OMEPRAZOLE]; CRESTOR OD. Vaccination history included: Moderna covid vaccine (Dose 1), administration date: 2021, for COVID-19 immunization; Moderna covid vaccine (Dose 2), administration date: 2021, for COVID-19 immunization. The following information was reported: CARBON DIOXIDE DECREASED (non-serious) with onset 13Jun2023, outcome "unknown", described as "CO2: 22"; BLOOD CREATININE INCREASED (non-serious) with onset 13Jun2023, outcome "unknown", described as "Creatinine: 10.2"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Jun2023 at 15:20, outcome "unknown", described as "Caller says the patient last got 2 moderna doses back on 2021"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 13Jun2023 at 15:20, outcome "unknown", described as "Expiration on the vial itself shows Sep2022/administration date: 13Jun2023"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 13Jun2023 at 15:20, outcome "unknown" and all described as "it was first punctured yesterday at 4pm but was still given today at 3:20PM". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the "vials were first punctured yesterday at 4 PM but were still given today at 3:20 PM to a patient". The reporter stated that prior to this, the patient just had 2 Moderna doses back in 2021. Further, the expiration date of the vial shows Sep2022. Lab work was done on 13Jun2023 and included albumin: 4.6, ALK phosphate: 72, ALT: 27, AST: 19, BUN: 13, Calcium: 9.9, Chloride: 106, CO2: 22, creatinine: 1.3, globulin: 3.4, glucose: 227, potassium: 4.3, sodium: 140, total bili: 0.6, protein: 8.0, and creatinine: 10.2 . The patient had no prior vaccinations (4 week)
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood calcium, Blood chloride, Blood creatinine, Blood creatinine increased, Blood glucose
Clinical narrative: Caller says the patient last got 2 moderna doses back on 2021; Expiration on the vial itself shows Sep2022/administration date: 13Jun2023; it was first punctured yesterday at 4pm but was still given today at 3:20PM; it was first punctured yesterday at 4pm but was still given today at 3:20PM; Creatinine: 10.2; CO2: 22; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: ().  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jun2023 at 15:20 as dose 3 (booster), 0.3 ml single (Lot number: GL2042, Expiration Date: Sep2022) at the age of 54 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AZOR [AMLODIPINE BESILATE;OLMESARTAN MEDOXOMIL]; XIGDUO XR; METFORMIN [METFORMIN HYDROCHLORIDE]; PRILOSEC [OMEPRAZOLE]; CRESTOR OD. Vaccination history included: Moderna covid vaccine (Dose 1), administration date: 2021, for COVID-19 immunization; Moderna covid vaccine (Dose 2), administration date: 2021, for COVID-19 immunization. The following information was reported: CARBON DIOXIDE DECREASED (non-serious) with onset 13Jun2023, outcome "unknown", described as "CO2: 22"; BLOOD CREATININE INCREASED (non-serious) with onset 13Jun2023, outcome "unknown", described as "Creatinine: 10.2"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Jun2023 at 15:20, outcome "unknown", described as "Caller says the patient last got 2 moderna doses back on 2021"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 13Jun2023 at 15:20, outcome "unknown", described as "Expiration on the vial itself shows Sep2022/administration date: 13Jun2023"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 13Jun2023 at 15:20, outcome "unknown" and all described as "it was first punctured yesterday at 4pm but was still given today at 3:20PM". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the "vials were first punctured yesterday at 4 PM but were still given today at 3:20 PM to a patient". The reporter stated that prior to this, the patient just had 2 Moderna doses back in 2021. Further, the expiration date of the vial shows Sep2022. Lab work was done on 13Jun2023 and included albumin: 4.6, ALK phosphate: 72, ALT: 27, AST: 19, BUN: 13, Calcium: 9.9, Chloride: 106, CO2: 22, creatinine: 1.3, globulin: 3.4, glucose: 227, potassium: 4.3, sodium: 140, total bili: 0.6, protein: 8.0, and creatinine: 10.2 . The patient had no prior vaccinations (4 week)
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium, Blood sodium, Blood urea, Carbon dioxide, Carbon dioxide decreased
Clinical narrative: Caller says the patient last got 2 moderna doses back on 2021; Expiration on the vial itself shows Sep2022/administration date: 13Jun2023; it was first punctured yesterday at 4pm but was still given today at 3:20PM; it was first punctured yesterday at 4pm but was still given today at 3:20PM; Creatinine: 10.2; CO2: 22; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: ().  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jun2023 at 15:20 as dose 3 (booster), 0.3 ml single (Lot number: GL2042, Expiration Date: Sep2022) at the age of 54 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AZOR [AMLODIPINE BESILATE;OLMESARTAN MEDOXOMIL]; XIGDUO XR; METFORMIN [METFORMIN HYDROCHLORIDE]; PRILOSEC [OMEPRAZOLE]; CRESTOR OD. Vaccination history included: Moderna covid vaccine (Dose 1), administration date: 2021, for COVID-19 immunization; Moderna covid vaccine (Dose 2), administration date: 2021, for COVID-19 immunization. The following information was reported: CARBON DIOXIDE DECREASED (non-serious) with onset 13Jun2023, outcome "unknown", described as "CO2: 22"; BLOOD CREATININE INCREASED (non-serious) with onset 13Jun2023, outcome "unknown", described as "Creatinine: 10.2"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Jun2023 at 15:20, outcome "unknown", described as "Caller says the patient last got 2 moderna doses back on 2021"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 13Jun2023 at 15:20, outcome "unknown", described as "Expiration on the vial itself shows Sep2022/administration date: 13Jun2023"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 13Jun2023 at 15:20, outcome "unknown" and all described as "it was first punctured yesterday at 4pm but was still given today at 3:20PM". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that the "vials were first punctured yesterday at 4 PM but were still given today at 3:20 PM to a patient". The reporter stated that prior to this, the patient just had 2 Moderna doses back in 2021. Further, the expiration date of the vial shows Sep2022. Lab work was done on 13Jun2023 and included albumin: 4.6, ALK phosphate: 72, ALT: 27, AST: 19, BUN: 13, Calcium: 9.9, Chloride: 106, CO2: 22, creatinine: 1.3, globulin: 3.4, glucose: 227, potassium: 4.3, sodium: 140, total bili: 0.6, protein: 8.0, and creatinine: 10.2 . The patient had no prior vaccinations (4 week)