chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 004E21A, 031B21A and 002B21A) for COVID-19 vaccination.     Patient had no allergic reaction.  Previously administered products included for Flu vaccination: Flu vaccine on 28-Oct-2022. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Diabetes, Hypertension, Blood cholesterol increased (Elevated), Thyroid disorder (Thyroid problem) and Cancer in remission. Concomitant products included ANASTROZOLE for Cancer in remission, METFORMIN, LEVOTHYROXINE, BENAZEPRIL and ATORVASTATIN for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2022, the patient experienced COVID-19 (Covid). At the time of the report, COVID-19 (Covid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2022, SARS-CoV-2 test: Positive.         Patient reported that patient had 12th day of COVID-19 and patient still had congestion in the head,rough throat and cough occasionally but not very often. Patient thought that actual Covid symptoms were gone. The adverse event did not cause patient to seek medical care . She had all medical conditions prior to getting the vaccine and they have been stable. The patient did not experienced a similar event in the past.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia
Clinical narrative: felt like she had the flu; headaches; body aches; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu), HEADACHE (headaches) and MYALGIA (body aches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 016C21A) for COVID-19 prophylaxis.     Concomitant products included LAMOTRIGINE (LAMICTAL), MIRTAZAPINE, QUETIAPINE, CLONAZEPAM (KLONOPIN), ASPIRIN [ACETYLSALICYLIC ACID], BACLOFEN, FUROSEMIDE (LASIX [FUROSEMIDE]), POTASSIUM CHLORIDE, ATORVASTATIN, PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA), ISOSORBIDE, TRAZODONE and TOPIRAMATE for an unknown indication.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), HEADACHE (headaches) and MYALGIA (body aches). At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu), HEADACHE (headaches) and MYALGIA (body aches) was resolving.            No medical history information was reported. It was reported that patient had no adverse reactions after dose 1. Patient did not remember which arm she received the vaccine in. Patient felt much better the next day after dose 2 vaccination. No treatment drug details was reported.   This case was linked to MOD-2022-675636 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received a bivalent dose of the vaccine as a second dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (received a bivalent dose of the vaccine as a second dose) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (received a bivalent dose of the vaccine as a second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received a bivalent dose of the vaccine as a second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received a bivalent dose of the vaccine as a second dose).    No concomitant information was reported.  Reporter stated that in other facility a patient received one dose of the monovalent vaccine as a first dose of the Moderna COVID19 vaccine and as a second dose she received a bivalent dose of the vaccine.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"(intended for pediatric primary series age group 6-11 yrs old); This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"(intended for pediatric primary series age group 6-11 yrs old)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"(intended for pediatric primary series age group 6-11 yrs old)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"(intended for pediatric primary series age group 6-11 yrs old)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"(intended for pediatric primary series age group 6-11 yrs old)).    No concomitant medications were reported.  The adult patient (above 18) inadvertently received Bivalent booster dose from a Moderna "for booster dose only vial" which was intended for pediatric primary series age group 6-11 years old.  No treatment medications were reported.  This case contains information for the 3 rd of 4th adult patients described by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2022-675671 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675671:patient 1
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial") and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial") and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial").    No concomitant medications were reported.  The adult patient (above 18) inadvertently received Bivalent booster dose from a Moderna "for booster dose only vial" which was intended for pediatric primary series age group 6-11 years old. No treatment medications were reported.  This case contains information for the 4th of 4 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-675671, US-MODERNATX, INC.-MOD-2022-675700 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675671:Patient 1 US-MODERNATX, INC.-MOD-2022-675700:Patient 2
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pain in extremity, Rash erythematous
Clinical narrative: small blisters on both palms; had sore arm; had a bunch of red rashes all over body; This spontaneous case was reported by a patient and describes the occurrence of BLISTER (small blisters on both palms), PAIN IN EXTREMITY (had sore arm) and RASH ERYTHEMATOUS (had a bunch of red rashes all over body) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H21A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: Flu shot (within the last couple of months). Past adverse reactions to the above products included No adverse event with Flu shot.    On 14-Nov-2022, 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. In November 2022, the patient experienced BLISTER (small blisters on both palms), PAIN IN EXTREMITY (had sore arm) and RASH ERYTHEMATOUS (had a bunch of red rashes all over body). At the time of the report, BLISTER (small blisters on both palms), PAIN IN EXTREMITY (had sore arm) and RASH ERYTHEMATOUS (had a bunch of red rashes all over body) had not resolved.            Concomitant drugs were not reported.  Patient received dose 1 of Moderna on 11-Feb-2021 with lot number 030M20A, dose 2 on 11-Mar-2021 with lot number 030M20A and 1st booster dose on 09-Dec-2021 with lot number 056M21A.  It was reported that patient never had similar events in the past and did not seek any medical care.  Treatment medications were not provided.   This case was linked to MOD-2022-675721 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He also stated that he had sore arm after each dose; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (He also stated that he had sore arm after each dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 032M20A and 056M21A) for COVID-19 vaccination.     Patient had no allergies. patient never had COVID + test or diagnosis.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (He also stated that he had sore arm after each dose). At the time of the report, PAIN IN EXTREMITY (He also stated that he had sore arm after each dose) had not resolved.            No concomitant medications was reported. Patient had no acute or chronic illnesses at the time of vaccination.  Other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose #) was flu vaccine wihtin the last couple of months.  The event onset date for Sore arm for dose 2 was Mar-2021 and for dose 3 was dec-2021.  Adverse event cause patient to seek medical care (office visit, Urgent care, ER, hospitalized) reported as no. The patient did not experienced a similar event in the past.  No treatment drug details was reported.   This case was linked to MOD-2022-675716 (Patient Link).
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator 14 Nov 2022, vial was first punctured 19 Nov 2022, Stored post puncture in Room temperature; No adverse event; A couple of patients got a dose from a vial that had been punctured & was beyond 12 hrs.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A couple of patients got a dose from a vial that had been punctured & was beyond 12 hrs.), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 14 Nov 2022, vial was first punctured 19 Nov 2022, Stored post puncture in Room temperature) and NO ADVERSE EVENT (No adverse event) in a 65-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. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A couple of patients got a dose from a vial that had been punctured & was beyond 12 hrs.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 14 Nov 2022, vial was first punctured 19 Nov 2022, Stored post puncture in Room temperature) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A couple of patients got a dose from a vial that had been punctured & was beyond 12 hrs.), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 14 Nov 2022, vial was first punctured 19 Nov 2022, Stored post puncture in Room temperature) 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 (A couple of patients got a dose from a vial that had been punctured & was beyond 12 hrs.) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator 14 Nov 2022, vial was first punctured 19 Nov 2022, Stored post puncture in Room temperature).    No concomitant medications was reported.  The vial size was 2.5 ml. The vial was initially stored in the refrigerator on 14-Nov-2022. The vial was first punctured on 19-Nov-2022. Exact time of puncture was unknown. The vial was stored in room temperature post puncture. The vial does not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range was Afternoon/evening time. It was used at 10a.  No treatment medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurry vision after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurry vision after the vaccine) 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)) for COVID-19 vaccination.     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 VISION BLURRED (blurry vision after the vaccine). At the time of the report, VISION BLURRED (blurry vision after the vaccine) outcome was unknown.            No concomitant medication was reported.   Reporter contacted pharmacist who informed that, a co-worker experienced blurry vision after the vaccine. Reporter did not believe that visual changes was attributed to the vaccine.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-675632, US-MODERNATX, INC.-MOD-2022-675826 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675632:reporter's case US-MODERNATX, INC.-MOD-2022-675826:Other patient case
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurry vision after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurry vision after the vaccine) 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)) 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 VISION BLURRED (blurry vision after the vaccine). At the time of the report, VISION BLURRED (blurry vision after the vaccine) outcome was unknown.            No concomitant medication were reported.  Reporter mentioned that she contacted her pharmacist, who informed that a patient have experienced blurry vision after the vaccine.  Reporter doesn't believe that visual changes was attributed to the vaccine.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-675825, US-MODERNATX, INC.-MOD-2022-675632 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675825:Other patient case US-MODERNATX, INC.-MOD-2022-675632:
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Unspecified AE after 1st booster; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Unspecified AE after 1st booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced IMMUNISATION REACTION (Unspecified AE after 1st booster). At the time of the report, IMMUNISATION REACTION (Unspecified AE after 1st booster) had not resolved.            No concomitant medications were reported.  The patient received unknown treatment after AEs from 1st booster.   This case was linked to MOD-2022-675837 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 1 booster dose of Moderna that was expired.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 1 booster dose of Moderna that was expired.) 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. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 1 booster dose of Moderna that was expired.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 1 booster dose of Moderna that was expired.) 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 (We gave 1 booster dose of Moderna that was expired.).    No concomitant medications was provided. The Vial size was 2.5 ml the vial did not undergo any temperature excursions. Reporter was unsure that the patient has taken Moderna Covid-19 Vaccine, Bivalent or Monovalent. No treatment medications was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: friend had a mini stroke after receiving the second dose of his Moderna primary Series.; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (friend had a mini stroke after receiving the second dose of his Moderna primary Series.) in a 65-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (friend had a mini stroke after receiving the second dose of his Moderna primary Series.) (seriousness criterion medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (friend had a mini stroke after receiving the second dose of his Moderna primary Series.) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.  Company comment: This is a regulatory case concerning a 65-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) adverse event of special interest of Transient ischaemic attack. The event occurred on unknown day after the second dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a regulatory case concerning a 65-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) adverse event of special interest of Transient ischaemic attack. The event occurred on unknown day after the second dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in refrigerator post puncture; No adverse event; Received expired Bivalent booster beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster beyond 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored in refrigerator post puncture) and NO ADVERSE EVENT (No adverse event) in a 35-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2022 at 2:10 PM, 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 22-Nov-2022 at 2:10 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster beyond 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in refrigerator post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster beyond 12 hours post puncture), PRODUCT STORAGE ERROR (The vial was stored in refrigerator 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster beyond 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was stored in refrigerator post puncture).    No concomitant medications were reported.  It was reported that individual vials was first punctured on 21-Nov-2022 at 8:15AM. The vial did not undergo any temperature excursions. Vial was not stored at room Temperature. It was exposed to refrigerator temperature after first puncture for less than 24 hours. The vial was initially stored in the refrigerator was on 16-Nov-2022.   No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 2 bivalent doses given within a day to a patient; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (2 bivalent doses given within a day to a patient) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (2 bivalent doses given within a day to a patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (2 bivalent doses given within a day 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 EXTRA DOSE ADMINISTERED (2 bivalent doses given within a day to a patient).    No concomitant medications was reported. No treatment drug details was reported.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired Moderna COVID-19 vaccine administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 vaccine administered to patient) and NO ADVERSE EVENT (No adverse event) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 vaccine administered 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 Moderna COVID-19 vaccine administered to patient) 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 EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 vaccine administered to patient).    Vial size was 2.5 mL. The vial was stored in freezer up until administration. The vial does not undergone any temperature excursions.  No concomitant medications was reported. No treatment medications was reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: Left arm was sore; Muscle aches; Headaches; This spontaneous case was reported by a medical assistant and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore), MYALGIA (Muscle aches) and HEADACHE (Headaches) in a 27-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Oct-2022, the patient experienced VACCINATION SITE PAIN (Left arm was sore), MYALGIA (Muscle aches) and HEADACHE (Headaches). At the time of the report, VACCINATION SITE PAIN (Left arm was sore), MYALGIA (Muscle aches) and HEADACHE (Headaches) outcome was unknown.    mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were provided. No treatment medication was provided.   This case was linked to MOD-2022-676532 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: injection site warm to the touch; painful injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (injection site warm to the touch) and VACCINATION SITE PAIN (painful injection site) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 prophylaxis.     The patient's past medical history included Melanoma (Melanoma develop on back. The patient says the melanoma was related to sun damage. The melanoma was removed.).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm to the touch) and VACCINATION SITE PAIN (painful injection site). At the time of the report, VACCINATION SITE WARMTH (injection site warm to the touch) and VACCINATION SITE PAIN (painful injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-676548, MOD-2022-676549, MOD-2022-676551 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malignant melanoma, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site warm to the touch; painful injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (injection site warm to the touch) and VACCINATION SITE PAIN (painful injection site) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 prophylaxis.     The patient's past medical history included Melanoma (Melanoma develop on back. The patient says the melanoma was related to sun damage. The melanoma was removed.).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm to the touch) and VACCINATION SITE PAIN (painful injection site). At the time of the report, VACCINATION SITE WARMTH (injection site warm to the touch) and VACCINATION SITE PAIN (painful injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-676548, MOD-2022-676549, MOD-2022-676551 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: injection site warm to the touch; painful injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (injection site warm to the touch) and VACCINATION SITE PAIN (painful injection site) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 prophylaxis.     The patient's past medical history included Melanoma (Melanoma develop on back. The patient says the melanoma was related to sun damage. The melanoma was removed.).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm to the touch) and VACCINATION SITE PAIN (painful injection site). At the time of the report, VACCINATION SITE WARMTH (injection site warm to the touch) and VACCINATION SITE PAIN (painful injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2022-676548, MOD-2022-676549, MOD-2022-676551 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Patient remembers being sleepy; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Patient remembers being sleepy) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 011L20A and 007H20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (Patient remembers being sleepy). At the time of the report, SOMNOLENCE (Patient remembers being sleepy) outcome was unknown.            No concomitant medication was reported.    Due to Melanoma, the patient received Moderna Covid 19 vaccine third full dose. No treatment information was reported.   This case was linked to MOD-2022-676537, MOD-2022-676548, MOD-2022-676551 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malignant melanoma, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient remembers being sleepy; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Patient remembers being sleepy) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 011L20A and 007H20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (Patient remembers being sleepy). At the time of the report, SOMNOLENCE (Patient remembers being sleepy) outcome was unknown.            No concomitant medication was reported.    Due to Melanoma, the patient received Moderna Covid 19 vaccine third full dose. No treatment information was reported.   This case was linked to MOD-2022-676537, MOD-2022-676548, MOD-2022-676551 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: Patient remembers being sleepy; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (Patient remembers being sleepy) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 011L20A and 007H20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (Patient remembers being sleepy). At the time of the report, SOMNOLENCE (Patient remembers being sleepy) outcome was unknown.            No concomitant medication was reported.    Due to Melanoma, the patient received Moderna Covid 19 vaccine third full dose. No treatment information was reported.   This case was linked to MOD-2022-676537, MOD-2022-676548, MOD-2022-676551 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site warmth
Clinical narrative: warmth at the injection site; Soreness at the injection site; tiredness that lasted for 3 days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (warmth at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and FATIGUE (tiredness that lasted for 3 days) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-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 16-Sep-2022, the patient experienced VACCINATION SITE WARMTH (warmth at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and FATIGUE (tiredness that lasted for 3 days). At the time of the report, VACCINATION SITE WARMTH (warmth at the injection site) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown and FATIGUE (tiredness that lasted for 3 days) had resolved.            No concomitant medications were reported.  The patient received his first Moderna Covid 19 vaccine primary series on 19JAN2021 Lot number 011L20A, second Moderna Covid 19 vaccine primary series on 16FEB2021 Lot number 007H20A, third full dose on 22OCT2021 Lot number 014F21A and first booster dose on 19MAR2022 Lot number 033ZX21-2A.   Patient reported adverse reactions of tiredness that lasted for 3 days. Event end date will be in SEP-2022.  No treatment medications were reported.   This case was linked to MOD-2022-676537, MOD-2022-676548, MOD-2022-676549 (Patient Link).
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Feeling tired; Muscle aches; Chills; Headache; Dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2022, the patient received Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced tiredness, muscle pain, chills, headache and dizziness. On an unknown date, the outcome of the tiredness, muscle pain, chills, headache and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, muscle pain, chills, headache and dizziness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received vaccine about 26 hours ago. The patient experienced feeling tired, muscle aches, chills, headache and some dizziness. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2022, the patient received Shingles vaccine. On 14th November 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the shingles shot a week ago.  The patient experienced rash before the day of reporting and physician could not see untill Friday.  The patient was asking should he/she go to urgent care or the shot was going to help from getting severe. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vaccine was'nt combined with powder; Pt only received suspension; This case was reported by a other health professional via interactive digital media and described the occurrence of inappropriate preparation of medication in a 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's Comment: This case was reported by a healthcare provider via interactive digital media. The vaccine was administered to a patient without combining lyophilized varicella zoster virus glycoprotein E (gE) antigen component (powder). The patient only received the suspension. The reporter asked what were the recommendations for repeat dosing. Additional supportive information: The vaccine was administered to a patient without combining lyophilized varicella zoster virus glycoprotein E (gE) antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: I did wait more than the recommended time for each shot; arm is still sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On 14th November 2022, the patient received the 2nd dose of Shingles vaccine. On 14th November 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. In November 2022, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient just had his/her second shot yesterday (on the day before reporting) and his/her arm was still sore but getting better. The patient did wait more than the recommended between time for each shot, but it was done. The patient stated that now to not be sore and then get his/her Flu and COVID booster. Additional supportive information: The patient received 2nd dose of Shingles vaccine later than the recommended interval, which led to lengthening of vaccination schedule. The follow-up would not possible, as no contact, details were available.