chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: After the 2nd shot, they had a rash at the injection site/ kind of 1 inch square; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (After the 2nd shot, they had a rash at the injection site/ kind of 1 inch square) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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 an unknown date, the patient experienced VACCINATION SITE RASH (After the 2nd shot, they had a rash at the injection site/ kind of 1 inch square). At the time of the report, VACCINATION SITE RASH (After the 2nd shot, they had a rash at the injection site/ kind of 1 inch square) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-649344 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin mass, Vaccination site reaction
Clinical narrative: lump on their left shoulder/the lump was still there until that day,they called it a lump that does not go away.; After the 3rd shot (1st booster dose), they had a whole Covid arm; COVID arm which turned to a red rash and lasted for over a month; This spontaneous case was reported by a patient and describes the occurrence of SKIN MASS (lump on their left shoulder/the lump was still there until that day,they called it a lump that does not go away.), VACCINATION SITE REACTION (After the 3rd shot (1st booster dose), they had a whole Covid arm) and RASH ERYTHEMATOUS (COVID arm which turned to a red rash and lasted for over a month) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (on the left arm) on 21-Nov-2021. Past adverse reactions to the above products included No adverse event with Flu vaccine.   On 30-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. In November 2021, the patient experienced VACCINATION SITE REACTION (After the 3rd shot (1st booster dose), they had a whole Covid arm) and RASH ERYTHEMATOUS (COVID arm which turned to a red rash and lasted for over a month). On 21-Dec-2021, the patient experienced SKIN MASS (lump on their left shoulder/the lump was still there until that day,they called it a lump that does not go away.). At the time of the report, SKIN MASS (lump on their left shoulder/the lump was still there until that day,they called it a lump that does not go away.) had not resolved and VACCINATION SITE REACTION (After the 3rd shot (1st booster dose), they had a whole Covid arm) and RASH ERYTHEMATOUS (COVID arm which turned to a red rash and lasted for over a month) had resolved.            No concomitant information was reported. It was reported that on 21-Dec-2021 patient was in hospital for a special infusion and lump was not on the deltoid area, not exactly on the injection site but above it. MRI was done because they thought it was a tumor and theywere told that it could be a fatty lipoma.  The patient's healthcare providers advised not to get the next booster dose since patient had the rash twice and it got much worse the second time around. It was reported that patient had to apply steroid on red rash because it would not go away on its own.   This case was linked to MOD-2022-649343 (Patient Link).   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; A drop of the vaccine fell on patient arm; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (A drop of the vaccine fell on patient arm) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2022, 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 19-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (A drop of the vaccine fell on patient arm). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (A drop of the vaccine fell on patient arm) 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 ACCIDENTAL UNDERDOSE (A drop of the vaccine fell on patient arm).    Patient was taking other medication.  On 04-Nov-2021, the patient had received the 1st booster dose of Moderna COVID-19 vaccine 0.25 mL in left arm intramuscularly (batch number: 051F21A). On 19-Sep-2022, the patient had received the 2nd booster dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)).  No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: I feel a little stuffy today/I feel like crap.; tested positive for Covid-19; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (I feel a little stuffy today/I feel like crap.) and COVID-19 (tested positive for Covid-19) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57144B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Patient had unknown allergies to (medications, food and other products). Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination was unknown.    On 09-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 and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 18-Sep-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (tested positive for Covid-19). On 22-Sep-2022, the patient experienced FEELING ABNORMAL (I feel a little stuffy today/I feel like crap.). At the time of the report, FEELING ABNORMAL (I feel a little stuffy today/I feel like crap.) and COVID-19 (tested positive for Covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2022, SARS-CoV-2 test: (Positive) tested positive for Covid-19.         No concomitant medications were provided by the reporter.  On 25-Jan-2021, the patient received first dose of Moderna vaccine (unknown route) 1 dosage form (batch no. 011L20A), on 28-Feb-2021, the patient received second dose of Moderna vaccine (unknown route) 1 dosage form (batch no. 002A21A), on 27-Oct-2021, the patient received 1st booster dose of Moderna vaccine (unknown route) 1 dosage form (batch no. 045C21A), on 20-Apr-2022, the patient received 2nd booster dose of Moderna vaccine (unknown route) 1 dosage form (batch no. 045L21A) for COVID-19 prophylaxis.  Event Covid-19 cause patient to seek medical care to (office visit, Urgent care, ER, hospitalized). The patient did not experienced a similar event in the past. Event Feeling abnormal did not cause patient to seek medical care to (office visit, Urgent care, ER, hospitalized).  No treatment medications were provided by the reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: One dose was drawn from the correct bivalent vial and the other was incorrectly drawn from the monovalent vial; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (One dose was drawn from the correct bivalent vial and the other was incorrectly drawn from the monovalent vial) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (One dose was drawn from the correct bivalent vial and the other was incorrectly drawn from the monovalent vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (One dose was drawn from the correct bivalent vial and the other was incorrectly drawn from the monovalent vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (One dose was drawn from the correct bivalent vial and the other was incorrectly drawn from the monovalent vial).    No relevant concomitant medications were reported.  There was a couple who were receiving their bivalent booster doses. One dose was drawn from the correct bivalent vial and the other was incorrectly drawn from the monovalent vial. The vaccines were drawn in the pharmacy and taken out to the patients to administer. Unfortunately, after video review could not verify which patient received the correct dose. This case is created for male patient.  The lot for the bivalent vaccine was AS7162B.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-649436 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-649436:same reporter
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid on 07Aug2022; Lack of drug effect; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for covid on 07Aug2022) and DRUG INEFFECTIVE (Lack of drug effect) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A, 018B21A and 048A21A) for COVID-19 vaccination.  Concurrent medical conditions included Drug allergy (Gabapentin), Allergy to NSAIDs (NSAIDS) and Multiple myeloma since 2019.  On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2022, the patient experienced COVID-19 (tested positive for covid on 07Aug2022) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (tested positive for covid on 07Aug2022) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2022, SARS-CoV-2 test: (Positive) Positive.  No concomitant medications were reported. No other vaccines were received by the patient within 1 month prior to Moderna COVID-19 vaccine. It was reported that patient was treated with infusion in the ER on 09-Aug-2022.  Company Comment: This is a Spontaneous case concerning 66-year-old female patient with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19. The event occurred approximately 8 months after the third dose of mRNA-1273. Doses 1 and 2 of mRNA-1273 were administered in an appropriate schedule of vaccination (28 days between doses). Lack of Efficacy was also noted in this case. It was reported that patient was treated with infusion in the ER. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning 66-year-old female patient with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19. The event occurred approximately 8 months after the third dose of mRNA-1273. Doses 1 and 2 of mRNA-1273 were administered in an appropriate schedule of vaccination (28 days between doses). Lack of Efficacy was also noted in this case. It was reported that patient was treated with infusion in the ER. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect booster administration; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Incorrect booster administration) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Incorrect booster administration) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Incorrect booster administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Incorrect booster administration).    No concomitant medication were reported.  It was reported that there was a couple who were received their bivalent booster doses. One dose was drawn from the correct bivalent vial and the other was incorrectly drawn from the monovalent vial. The vaccines were drawn in the pharmacy and taken out to the patients to administer. Unfortunately, after video review they could not verify which patient received the correct dose  The lot for the bivalent vaccine was  reported as AS7162B.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-649416 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-649416:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Severely allergic to that adjuvant both Pfizer and Moderna have used previously in the mRNA vaccines; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Severely allergic to that adjuvant both Pfizer and Moderna have used previously in the mRNA vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Comirnaty,Pfizer-BioNTech COVID-19 Vaccine (Previous dose, Comirnaty and Pfizer-BioNTech COVID-19 Vaccine). Past adverse reactions to the above products included Allergy to vaccine with Comirnaty andPfizer-BioNTech COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Severely allergic to that adjuvant both Pfizer and Moderna have used previously in the mRNA vaccines). At the time of the report, ALLERGY TO VACCINE (Severely allergic to that adjuvant both Pfizer and Moderna have used previously in the mRNA vaccines) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  Reported mentioned that there was one person who was severely allergic to that adjuvant both Pfizer and Moderna have used previously in the mRNA vaccines.  No treatment medications were provided by the reporter.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A sore left arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (A sore left arm) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B) for COVID-19 prophylaxis.     Concurrent medical conditions included Cirrhosis of liver and Hepatitis C.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (A sore left arm). At the time of the report, VACCINATION SITE PAIN (A sore left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient received second dose of his primary series on 18-May-2021 (lot number 038C21A). Patient received in left deltoid.  The patient received first Moderna booster dose on 15-Aug-2022 (lot number 017B22A). Patient received vaccine in the left arm deltoid.   Treatment information was not provided.   This case was linked to MOD-2022-649967 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Menstrual disorder, Weight increased
Clinical narrative: Skin problems/eczema; started gaining weight.; Period problems/hormonal problems; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Skin problems/eczema), WEIGHT INCREASED (started gaining weight.) and MENSTRUAL DISORDER (Period problems/hormonal problems) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027620A) for COVID-19 prophylaxis.     Concurrent medical conditions included Heart disorder (She has had already a year-round of hearth problems).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ECZEMA (Skin problems/eczema), WEIGHT INCREASED (started gaining weight.) and MENSTRUAL DISORDER (Period problems/hormonal problems). At the time of the report, ECZEMA (Skin problems/eczema), WEIGHT INCREASED (started gaining weight.) and MENSTRUAL DISORDER (Period problems/hormonal problems) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  It was reported that patient was prescribed medication for the symptoms started one month after receiving the first dose of the Moderna Vaccine.   This case was linked to MOD-2022-649986, MOD-2022-649987 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hormone level abnormal, Uterine cyst
Clinical narrative: Cyst in Uterus; hormonal problems; This spontaneous case was reported by a patient and describes the occurrence of UTERINE CYST (Cyst in Uterus) and HORMONE LEVEL ABNORMAL (hormonal problems) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 027620A) for COVID-19 prophylaxis.     Patient never had myocarditis or pericarditis. Patient was never tested positive for COVID-19.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced UTERINE CYST (Cyst in Uterus) and HORMONE LEVEL ABNORMAL (hormonal problems). At the time of the report, UTERINE CYST (Cyst in Uterus) and HORMONE LEVEL ABNORMAL (hormonal problems) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-649984, MOD-2022-649987 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: Got Pfizer covid-19 vaccine as first dose and inadvetantly got Moderna for second dose; Got Pfizer covid-19 vaccine as first dose and inadvetantly got Moderna for second dose; No adverse reaction; This spontaneous case was reported by a physician and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Got Pfizer covid-19 vaccine as first dose and inadvetantly got Moderna for second dose), COVID-19 IMMUNISATION (Got Pfizer covid-19 vaccine as first dose and inadvetantly got Moderna for second dose) and NO ADVERSE EVENT (No adverse reaction) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Comirnaty (Dose 1). Past adverse reactions to the above products included No adverse event with Comirnaty.    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, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got Pfizer covid-19 vaccine as first dose and inadvetantly got Moderna for second dose), COVID-19 IMMUNISATION (Got Pfizer covid-19 vaccine as first dose and inadvetantly got Moderna for second dose) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Got Pfizer covid-19 vaccine as first dose and inadvetantly got Moderna for second dose), COVID-19 IMMUNISATION (Got Pfizer covid-19 vaccine as first dose and inadvetantly got Moderna for second dose) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Got Pfizer covid-19 vaccine as first dose and inadvetantly got Moderna for second dose) and COVID-19 IMMUNISATION (Got Pfizer covid-19 vaccine as first dose and inadvetantly got Moderna for second dose).    No concomitant medication was reported. Caller believed that child is around 3 years old. No treatment medication was reported.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; After the thaw date expiration (30 day use by date); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the thaw date expiration (30 day use by date)) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the thaw date expiration (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 (After the thaw date expiration (30 day use by date)) 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 EXPIRED PRODUCT ADMINISTERED (After the thaw date expiration (30 day use by date)).    No concomitant medications were reported. On 09-Aug-2022, the vial was thawed. Patient received vaccine after it had been stored more than 30 days past the initial thaw date.  Patient received primary series doses of the 6m-5y presentation of the Moderna COVID-19 vaccine(lot number AS1414B, expiration date unknown). All patients have not reported any symptoms.  Patient did not receive any additional doses, medications or treatments to the knowledge of the vaccination provider. No treatment medications were reported.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine had been stored more than 30 days past the initial thaw date; No adverse event; Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date), PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date), PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose of the moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date) and PRODUCT STORAGE ERROR (vaccine had been stored more than 30 days past the initial thaw date).    No concomitant medications were reported.  On 09-Aug-2022, the vial was thawed and was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Patient has not reported any symptoms. Patient did not receive any additional doses, medications or treatments to the knowledge of the vaccination provider.  No treatment medications were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: incorrect vaccine administration/patient received Monovalent dose 0.5mL dose for age group 6-11 yrs old instead of Bivalent booster dose 0.5mL; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (incorrect vaccine administration/patient received Monovalent dose 0.5mL dose for age group 6-11 yrs old instead of Bivalent booster dose 0.5mL) and NO ADVERSE EVENT (No adverse effect) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (incorrect vaccine administration/patient received Monovalent dose 0.5mL dose for age group 6-11 yrs old instead of Bivalent booster dose 0.5mL) and NO ADVERSE EVENT (No adverse effect). At the time of the report, WRONG PRODUCT ADMINISTERED (incorrect vaccine administration/patient received Monovalent dose 0.5mL dose for age group 6-11 yrs old instead of Bivalent booster dose 0.5mL) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse effect) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (incorrect vaccine administration/patient received Monovalent dose 0.5mL dose for age group 6-11 yrs old instead of Bivalent booster dose 0.5mL).    No concomitant medication information was provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Follow up received that contains significant information that includes new reporter, patient details, event details, suspect product route of administration, indication and batch lot no. with expiration date.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; received the bivalent booster dose before 2 months of her last dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the bivalent booster dose before 2 months of her last dose of the Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140c) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the bivalent booster dose before 2 months of her last dose of the Moderna COVID19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the bivalent booster dose before 2 months of her last dose of the Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the bivalent booster dose before 2 months of her last dose of the Moderna COVID19 vaccine).    It was reported that the patients last dose was given on 07-Aug-2022. Concomitant medication list was not provided. It was reported that the patient received bivalent booster less than 2 months after their last booster. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received: updated narrative.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Thrombosis
Clinical narrative: heart attack; clot in lung or heart; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) and THROMBOSIS (clot in lung or heart) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included Clot blood (patient had clots years ago.).    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criterion hospitalization) and THROMBOSIS (clot in lung or heart) (seriousness criterion hospitalization). At the time of the report, MYOCARDIAL INFARCTION (heart attack) and THROMBOSIS (clot in lung or heart) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant and Treatment medication list was not provided. Age of the patient was reported was reported between 38-40 years old.  Company comment: This spontaneous case concerns a male patient between 38-40 years of age,  with relevant medical history of thrombosis, who experienced the unexpected serious (hospitalization) events of Myocardial infarction (AESI) and AESI of Thrombosis (reported as clot in lung or heart), unknown days after receiving an unspecified dose with mRNA-1273 vaccine. No information on detailed clinical course, investigations, treatment of the event was available in the report.  Medical history of thrombosis could be confounding the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient between 38-40 years of age,  with relevant medical history of thrombosis, who experienced the unexpected serious (hospitalization) events of Myocardial infarction (AESI) and AESI of Thrombosis (reported as clot in lung or heart), unknown days after receiving an unspecified dose with mRNA-1273 vaccine. No information on detailed clinical course, investigations, treatment of the event was available in the report.  Medical history of thrombosis could be confounding the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date.) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date.) 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 EXPIRED PRODUCT ADMINISTERED (Patient received of the Moderna COVID-19 vaccine after it had been stored more than 30 days past the initial thaw date.).    No concomitant medication was provided by reporter. The date the vial was initially stored in the refrigerator 22-Jul-2022. All patients have not reported any symptoms. No patients have received.any additional doses, medications or treatments to the knowledge of the vaccination provider. No temperature excursions.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine had been stored more than 30 days past the initial thaw date; No adverse event; Patient received dose after it had been stored more than 30 days past the initial thawdate; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after it had been stored more than 30 days past the initial thawdate), PRODUCT STORAGE ERROR (Vaccine had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after it had been stored more than 30 days past the initial thawdate). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine had been stored more than 30 days past the initial thaw date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after it had been stored more than 30 days past the initial thawdate), PRODUCT STORAGE ERROR (Vaccine had been stored more than 30 days past the initial thaw date) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose after it had been stored more than 30 days past the initial thawdate) and PRODUCT STORAGE ERROR (Vaccine had been stored more than 30 days past the initial thaw date).    No concomitant medications were reported.  On 09-Aug-2022, the vial was thawed and was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Patient had not reported any symptoms. Patient did not receive any additional doses, medications or treatments to the knowledge of the vaccination provider.   This case was linked to US-MODERNATX, INC.-MOD-2022-649988, US-MODERNATX, INC.-MOD-2022-650252, US-MODERNATX, INC.-MOD-2022-650249, US-MODERNATX, INC.-MOD-2022-650253, US-MODERNATX, INC.-MOD-2022-650288, US-MODERNATX, INC.-MOD-2022-650479 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-649988: US-MODERNATX, INC.-MOD-2022-650252: US-MODERNATX, INC.-MOD-2022-650249: US-MODERNATX, INC.-MOD-2022-650253: US-MODERNATX, INC.-MOD-2022-650288: US-MODERNATX, INC.-MOD-2022-650479:
Age: 39.0
Sex: U
Vaccine: COVID19-2
Symptoms: Device connection issue, No adverse event, Product leakage, Underdose
Clinical narrative: No adverse event; Vaccine underdose; While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.; While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine underdose), DEVICE CONNECTION ISSUE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.), PRODUCT LEAKAGE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.) and NO ADVERSE EVENT (No adverse event) in a 39-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)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Sep-2022, the patient experienced UNDERDOSE (Vaccine underdose), DEVICE CONNECTION ISSUE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.) and PRODUCT LEAKAGE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Vaccine underdose), DEVICE CONNECTION ISSUE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.), PRODUCT LEAKAGE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.) 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 UNDERDOSE (Vaccine underdose), DEVICE CONNECTION ISSUE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.) and PRODUCT LEAKAGE (While giving a dose of Moderna Covid-19 Vaccine, the needle wasn't tight & some leaked out.).    No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs; No adverse event; A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.), PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs) and NO ADVERSE EVENT (No adverse event) in a 58-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. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.), PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs) 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 POOR QUALITY PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.) and PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs).    No concomitant medication were reported.   The vial was initially stored in the refrigerator on 22-Sep-2022 at 5:15p and vial was opened for use on 22-Sep-2022 at 5:30p. The vial was first punctured on 22-Sep-2022 at 5:30p. The vial was stored post puncture at Room temperature. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range for 15 hrs.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose) 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 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose).    No concomitant medications were reported. No treatment details were reported. It was reported that, the vaccine administrator grabbed the underage Moderna 6 months to 5 years age vaccine and administered to the adult patient. This case contains information for the 1st of 5 Adult patient described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-650481, US-MODERNATX, INC.-MOD-2022-650482, US-MODERNATX, INC.-MOD-2022-650483, US-MODERNATX, INC.-MOD-2022-650485 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650481: US-MODERNATX, INC.-MOD-2022-650482: US-MODERNATX, INC.-MOD-2022-650483: US-MODERNATX, INC.-MOD-2022-650485: