chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 41-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 12th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 13-JAN-2023 Reporter Comment: The pharmacist reported they inadvertently administered an expired Twinrix (expired 1st January 2023) dose to a patient. The pharmacist called to inquire how to proceed. The reporter did not consent to follow up  Additional Supportive Information: The patient received an expired dose of Twinrix vaccine which led to expired vaccine used.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2022, didn´t received 2nd and 3rd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 28th February 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 13-JAN-2023 Reporter's Comment: The reporter stated that the patient did not receive the second and third dose after the first dose. The vaccine administration facility was the same as primary reporter. The healthcare professional did not give the details about the patient. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID POSITIVE; UNSTABLE FOR A LITTLE WHILE/SOME REACTION; FELT FAINT; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not aware of any allergic reaction but allergic to so many things. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (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.  The patient had small reaction after each dose, felt faint and unstable for a little while when treated with covid-19 vaccine ad26.cov2.s (Dose number in series 1), which wore off after several minutes (recovered). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (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. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had small reaction after each dose, felt faint or something like that, felt unstable for a little while which wore off after several minutes (Dose number in series 2). The patient was tested positive (covid-19 virus test) about six months after booster dose (Dose number in series 2). The covid-19 vaccine ad26.cov2.s worked well for the patient since the patient was allergic to so many thing.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unstable for a little while/some reaction, and felt faint, and the outcome of covid positive was not reported. This report was non-serious. This case, involving the same patient is linked to 20230129371. This case, from the same reporter is linked to 20230128189. This case was associated with product quality complaint: 90000267010 and 90000267011.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Red streaks on arm below area; This case was reported by a consumer and described the occurrence of erythema of extremities in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The caregiver reported that the patient received a dose of Shingles vaccine and had red streaks on arm below area. The symptoms were not treated. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product colour issue
Clinical narrative: No adverse event; product discoloration; Dose administered after the 30 day beyond use date; This spontaneous case was reported by an other health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after the 30 day beyond use date), NO ADVERSE EVENT (No adverse event) and PRODUCT COLOUR ISSUE (product discoloration) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 13-Jul-2021 and Moderna COVID-19 Vaccine on 02-Aug-2021; for an unreported indication: Moderna COVID-19 Vaccine on 09-Mar-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 13-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 13-Jan-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 the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and PRODUCT COLOUR ISSUE (product discoloration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after the 30 day beyond use date), NO ADVERSE EVENT (No adverse event) and PRODUCT COLOUR ISSUE (product discoloration) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after the 30 day beyond use date) to have a relationship that was not reported, PRODUCT COLOUR ISSUE (product discoloration) to be not applicable.    Patient had vaccine on 02Aug2021, 13Jul2021 and 09Mar2022. No concomitant and treatment medication were reported.   Reporter did not allow further contact
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; 10-year-old patient received a booster dose of Moderna COVID-19 vaccine from a Bivalent vial dark pink cap and yellow label on 12-Jan-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (10-year-old patient received a booster dose of Moderna COVID-19 vaccine from a Bivalent vial dark pink cap and yellow label on 12-Jan-2023.) and NO ADVERSE EVENT (No Adverse Event) in a 10-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-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 12-Jan-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 (10-year-old patient received a booster dose of Moderna COVID-19 vaccine from a Bivalent vial dark pink cap and yellow label on 12-Jan-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (10-year-old patient received a booster dose of Moderna COVID-19 vaccine from a Bivalent vial dark pink cap and yellow label on 12-Jan-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 WRONG PRODUCT ADMINISTERED (10-year-old patient received a booster dose of Moderna COVID-19 vaccine from a Bivalent vial dark pink cap and yellow label on 12-Jan-2023.).    No relevant concomitant medications were reported.  No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine given to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     The patient's past medical history included GERD and Stroke. Concurrent medical conditions included Coronary artery disease, Hyperlipidemia, Hypothyroidism and Hypertension.    On 05-Jan-2023 at 10:57 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 05-Jan-2023 at 10:57 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient).    No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: exhausted; I literally can barely get up in the morning and and help myself. All I wanna do is sleep and I can't get over it; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhausted) and SOMNOLENCE (I literally can barely get up in the morning and and help myself. All I wanna do is sleep and I can't get over it) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     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 FATIGUE (exhausted) and SOMNOLENCE (I literally can barely get up in the morning and and help myself. All I wanna do is sleep and I can't get over it). At the time of the report, FATIGUE (exhausted) and SOMNOLENCE (I literally can barely get up in the morning and and help myself. All I wanna do is sleep and I can't get over it) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported as unknown whether the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that patient received vaccine a couple of three weeks back and had  been completely exhausted off the feet. Patient was literally can bare get up in the morning and and help on own. Patient want to do is a proper sleep and can't get over it and it's been almost a month now. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of the Moderna COVID-19 bivalent vaccine was administered to a patient; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (an expired dose of the Moderna COVID-19 bivalent vaccine was administered to a patient) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (an expired dose of the Moderna COVID-19 bivalent vaccine was administered to a patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (an expired dose of the Moderna COVID-19 bivalent vaccine was administered to a patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (an expired dose of the Moderna COVID-19 bivalent vaccine was administered to a patient).    Concomitant products were not reported.  Treatment medications were not reported.   Reporter did not allow further contact
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; one vaccine was given past 30 day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (one vaccine was given past 30 day use by date.) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient 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 13-Jan-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-Jan-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 (one vaccine was given past 30 day use by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (one vaccine was given past 30 day use by 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 (one vaccine was given past 30 day use by date.).    No concomitant medication was reported.  HCP stated that they had a shipment of Moderna Bivalent however it expired a day before reporting and one vaccine was given past 30 day use by date.  No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: She says that she had COVID in JUN2022 with symptoms of headache, fever, and coughing.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She says that she had COVID in JUN2022 with symptoms of headache, fever, and coughing.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE on 18-Mar-2021 and Moderna COVID-19 Vaccine on 15-Apr-2021. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and Moderna COVID-19 Vaccine.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (She says that she had COVID in JUN2022 with symptoms of headache, fever, and coughing.). At the time of the report, COVID-19 (She says that she had COVID in JUN2022 with symptoms of headache, fever, and coughing.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had COVID in JUN2022 with symptoms of headache, fever, and coughing. Patient's symptoms lasted for 4 days after which she was recovered.   No concomitant medication were reported. No treatment medication were reported.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Ovarian cyst, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OVARIAN CYST (two very large cyst (size of base ball and the other one was oblong like two golf balls put together)/ovaries could barely be seen because the cyst was so big/vaccine spiked proteins and activated them and made the cyst grow) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 031B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Postmenopause (Postmenopause in 2002/2003) and Partial hysterectomy (partial hysterectomy's in 2018/2019). Concurrent medical conditions included Penicillin allergy. Concomitant products included OMEPRAZOLE, ASCORBIC ACID (C 1000), B COMPLEX [AMINOBENZOIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE], BIFIDOBACTERIUM INFANTIS, LACTOBACILLUS ACIDOPHILUS (PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]), TOCOPHEROL (E 400), ZINC, COLECALCIFEROL (D3) and FLAXSEED for an unknown indication.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OVARIAN CYST (two very large cyst (size of base ball and the other one was oblong like two golf balls put together)/ovaries could barely be seen because the cyst was so big/vaccine spiked proteins and activated them and made the cyst grow) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 031B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Postmenopause (Postmenopause in 2002/2003) and Partial hysterectomy (partial hysterectomy's in 2018/2019). Concurrent medical conditions included Penicillin allergy. Concomitant products included OMEPRAZOLE, ASCORBIC ACID (C 1000), B COMPLEX [AMINOBENZOIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE], BIFIDOBACTERIUM INFANTIS, LACTOBACILLUS ACIDOPHILUS (PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]), TOCOPHEROL (E 400), ZINC, COLECALCIFEROL (D3) and FLAXSEED for an unknown indication.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) 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. AS7140C) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported. It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment medications were reported.  This case contains information for the 5th of 77 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product storage error; No Adverse Event; 13 patients administered an expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 patients administered an expired Moderna vaccine), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (13 patients administered an expired Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (13 patients administered an expired Moderna vaccine), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (13 patients administered an expired Moderna vaccine) and PRODUCT STORAGE ERROR (Product storage error).    Concomitant medication was not reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vials went from freezer to room temperature on days of administration. Dates of administration of vaccine were 14Apr2022, 21Apr2022, and 28Apr2022. Vial did not undergo any temperature excursions. 13 doses total given from 3 vials. Multi dose vials of 5.5mL. Age group of patients were mostly over 65 and they did report all of them in the VAERS website.  This case was related to patient number 1 out of 13patients.  Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697081, US-MODERNATX, INC.-MOD-2023-697097, US-MODERNATX, INC.-MOD-2023-697115, US-MODERNATX, INC.-MOD-2023-697138, US-MODERNATX, INC.-MOD-2023-697140, US-MODERNATX, INC.-MOD-2023-697170, US-MODERNATX, INC.-MOD-2023-697183, US-MODERNATX, INC.-MOD-2023-697200, US-MODERNATX, INC.-MOD-2023-697201 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697097: US-MODERNATX, INC.-MOD-2023-697081: US-MODERNATX, INC.-MOD-2023-697138: US-MODERNATX, INC.-MOD-2023-697140: US-MODERNATX, INC.-MOD-2023-697115: US-MODERNATX, INC.-MOD-2023-697201: US-MODERNATX, INC.-MOD-2023-697183: US-MODERNATX, INC.-MOD-2023-697170: US-MODERNATX, INC.-MOD-2023-697200: US-MODERNATX, INC.-MOD-2023-697213:Master case US-MODERNATX, INC.-MOD-2023-697333:Master case US-MODERNATX, INC.-MOD-2023-697284:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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. AS7140C) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided    For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant information was reported. It was reported that, approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information was reported. This case contains information for the 54th out of 77 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Maternal exposure during pregnancy, Unevaluable event
Clinical narrative: Hypertension; Unevaluable event; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of HYPERTENSION (Hypertension), UNEVALUABLE EVENT (Unevaluable event) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Caffeine consumption (caffeinated beverages less than 3 per day).    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 24-Jul-2022. On an unknown date, the patient experienced HYPERTENSION (Hypertension), UNEVALUABLE EVENT (Unevaluable event) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred  on 04-Jul-2022, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. Delivery was Live birth. No congenital anomalies was reported for neonate. At the time of the report, HYPERTENSION (Hypertension) and UNEVALUABLE EVENT (Unevaluable event) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant and treatment medications were not provided. Pregnancy outcome was reported as Live birth. Company comment-This spontaneous case concerns a pregnant female of unknown age, who experienced the unexpected non serious event of Maternal exposure during pregnancy which occurred in the context of mRNA-1273 vaccination. Hypertension and Unevaluable event (Other significant medical condition) were also reported as non-serious events. Gestation period at exposure and last menstrual period not provided. The outcome of pregnancy was live birth with no congenital anomalies. No further details available for review. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2022-683376 (Parent-Child Link).   See case US-MODERNATX, INC.-MOD-2022-683376 for details regarding the child case.
Sex: F
Vaccine: COVID19-2
Symptoms: Myocarditis
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (MYOCARDITIS) 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)) 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 MYOCARDITIS (MYOCARDITIS) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (MYOCARDITIS) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Severe rash; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (Severe rash) 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)) 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 RASH (Severe rash). At the time of the report, RASH (Severe rash) had resolved.            No concomitant medications were reported.   No treatment details were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; They have given 13 patients an expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine).    This case was considered as 2nd patient out of 13 patients.  It was reported that age group of patients were mostly over 65.  No concomitant medication information provided.  It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that 13 doses total given from 3 vials.  Vial size was multidose vials 5.5mL.  It was reported that vial was never put in the fridge. Vials went from freezer to room temperature on days of administration.   Dates vaccine was administered were reported as 14-Apr-2022, 21-Apr-2022 and 28-Apr-2022.  The vials did not undergo any temperature excursions.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696547 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696547:master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided        Dates vaccine was administered were reported as 14-Apr-2022, 21-Apr-2022 and 28-Apr-2022.  The vials did not undergo any temperature excursions.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; They have given 13 patients an expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine).    This case was considered as 4th patient out 13 patients.  It was reported that age group of patients were mostly over 65.  No concomitant medication information provided. It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that 13 doses total given from 3 vials.  Vial size was multidose vials 5.5mL.  It was reported that vial was never put in the fridge. Vials went from freezer to room temperature on days of administration.   Dates vaccine was administered were reported as 14-Apr-2022, 21-Apr-2022 and 28-Apr-2022.  The vials did not undergo any temperature excursions.  No treatment information provided.    This case was linked to US-MODERNATX, INC.-MOD-2023-696547 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696547:master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; They have given 13 patients an expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine).    This case was considered as 5th patient out 13 patients.  It was reported that age group of patients were mostly over 65.  No concomitant medication information provided. It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that 13 doses total given from 3 vials.  Vial size was multidose vials 5.5mL.  It was reported that vial was never put in the fridge. Vials went from freezer to room temperature on days of administration.   Dates vaccine was administered were reported as 14-Apr-2022, 21-Apr-2022 and 28-Apr-2022.  The vials did not undergo any temperature excursions.  No treatment information provided.    This case was linked to US-MODERNATX, INC.-MOD-2023-696547 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696547:master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; They have given 13 patients an expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine).    This case contains information for the 8 out of 13 Elderly patients described by the reporter.  No concomitant information was reported.  Vail never put in the fridge. Vials went from freezer to room temperature on days of administration. Dates of administration of vaccine were 14Apr2022, 21Apr2022, and 28Apr2022. Vial did not undergo any temperature excursions. 13 doses total given from 3 vials. Multi dose vials of 5.5mL. Age group of patients were mostly over 65 and they did report all of them in the VAERS website.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696547 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696547:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: ; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) ( No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given patient an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given patient an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given patient an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; They have given patient an expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given patient an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given patient an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given patient an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have given patient an expired Moderna vaccine).    This case is for 7th patient from 13 patient's case.  Concomitant product use was not provided by the reporter. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vials went from freezer to room temperature on days of administration. Dates of administration of vaccine were 14-Apr-2022, 21-Apr-2022, and 28-Apr-2022. Vial did not undergo any temperature excursions. 13 doses total given from 3 vials. Multi dose vial size was 5.5mL. Age group of patients were mostly over 65 and they did report all of them in the VAERS website. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696547 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696547:Master case