chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: 2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient; 2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 IMMUNISATION (2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient) and INTERCHANGE OF VACCINE PRODUCTS (2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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, the patient experienced COVID-19 IMMUNISATION (2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient) and INTERCHANGE OF VACCINE PRODUCTS (2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient). At the time of the report, COVID-19 IMMUNISATION (2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient) and INTERCHANGE OF VACCINE PRODUCTS (2nd dose of Moderna administered after 1st dose of Pfizer vaccine to a 5 year old patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. Patient had no known allergies for medications, food and other products.It was unknown that the patient ever  had or tested COVID-19 positive. It was unknown if patient experienced any symptoms or if patient was under any concomitant or regular medication. No treatment information were provided.   This case was linked to MOD-2022-616431 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 50-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Patient allergies were unknown.  Concurrent medical conditions included Hypertension (Blood pressure). Concomitant products included LOSARTAN for Hypertension, METFORMIN for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The patient never had COVID positive test or diagnosis.  No Acute and Chronic illnesses at the time of vaccination was reported. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was unknown. The patient experienced a similar event in the past was unknown. Adverse event did not cause the patient to seek medical care  Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-616413.   Reporter did not allow further contact
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     The patient had no allergies.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (primary series) and PFIZER BIONTECH COVID-19 VACCINE (primary series). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 19-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) 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 ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients).    No concomitant medication was reported. Dose number reported was first booster. No treatment medication was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Chills; Sore arm; Tired; 2nd booster dose 3 months after the 1st booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of CHILLS (Chills), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd booster dose 3 months after the 1st booster dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M21A and 056A22A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 28-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient experienced CHILLS (Chills), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd booster dose 3 months after the 1st booster dose). At the time of the report, CHILLS (Chills), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd booster dose 3 months after the 1st booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. Pharmacist did not know if patient was taking medication. No treatment medication were provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer vaccine (Primary series). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 19-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Dose: 1st booster dose. No concomitant medications was reported. No treatment medications was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients; gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) and NO ADVERSE EVENT (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients). At the time of the report, ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) and NO ADVERSE EVENT (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave a half a dose of 0.25 of a booster, from the purple vial that should be 0.5 for booster doses, to 3 patients).    No concomitant medications were reported. No treatment medications were reported.
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: 2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine; 2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 IMMUNISATION (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine), INTERCHANGE OF VACCINE PRODUCTS (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine) and NO ADVERSE EVENT (No adverse event) in a 4-year-old 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: Pfizer vaccine (1st dose). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    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 COVID-19 IMMUNISATION (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine), INTERCHANGE OF VACCINE PRODUCTS (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, COVID-19 IMMUNISATION (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine), INTERCHANGE OF VACCINE PRODUCTS (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for COVID-19 IMMUNISATION (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine) and INTERCHANGE OF VACCINE PRODUCTS (2nd dose of Moderna vaccine administered after 1st dose of Pfizer vaccine).    It was unknown if patient was under any concomitant or regular medication. It was reported that the patient was administered second dose of Moderna COVID-19 Vaccine after a previous first dose of Pfizer vaccine. It was unknown if patient experienced any symptoms. It was unknown if any treatment was given.   This case was linked to MODERNATX, INC.-MOD-2022-616411 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2022-616411:Case crosslinked with MOD22-020043(Different patient)
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Malaise, Pyrexia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of DELIRIUM (Delirious), MALAISE (Not feeling up to par/It's no fun not feeling well) and PYREXIA (fever/high fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 DELIRIUM (Delirious), MALAISE (Not feeling up to par/It's no fun not feeling well) and PYREXIA (fever/high fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, DELIRIUM (Delirious), MALAISE (Not feeling up to par/It's no fun not feeling well) and PYREXIA (fever/high fever) had resolved. No concomitant medications were reported. Patient had a reaction after every vaccine. Patient got the Moderna and the booster. Patient's doctor told she had an awesome immune system. She reported that her reactions lasted for 24-36 hours. Patient took Tylenol to keep fever down. Patient was scheduled to have a second booster on Thursday. Patient did not like to take medications and was very cautious with keeping safe. Patient did not had COVID, knock on wood. This case was linked to MOD-2022-616436 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (felt tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A, 001A21A and 039K20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Seasonal allergy (seasonal allergies), Seafood allergy (shrimp) and Penicillin allergy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-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 an unknown date, the patient experienced FATIGUE (felt tired). At the time of the report, FATIGUE (felt tired) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2022-616435 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (The woman who gave her the shot pulled the needle out and when she pulled it out the vaccine squirted out all over), UNDERDOSE (When she pulled it out the vaccine squirted out all over/Do not think I got the vaccination) and NO ADVERSE EVENT (Has no had any side effects/No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 022C21A, 001A21A and 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy, Seafood allergy and Penicillin allergy. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-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 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (The woman who gave her the shot pulled the needle out and when she pulled it out the vaccine squirted out all over) and UNDERDOSE (When she pulled it out the vaccine squirted out all over/Do not think I got the vaccination). On an unknown date, the patient experienced NO ADVERSE EVENT (Has no had any side effects/No adverse event). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (The woman who gave her the shot pulled the needle out and when she pulled it out the vaccine squirted out all over), UNDERDOSE (When she pulled it out the vaccine squirted out all over/Do not think I got the vaccination) and NO ADVERSE EVENT (Has no had any side effects/No adverse event) outcome was unknown. No concomitant medication were reported. The first booster vaccine was taken on 22-Oct-2021 and the second booster was taken on 11-May-2022. No treatment medication were reported. This case was linked to MOD-2022-616433 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (reaction after every vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (reaction after every vaccine). At the time of the report, IMMUNISATION REACTION (reaction after every vaccine) had resolved. The doctor told her that she has an awesome immune system, and she appreciated that her reactions lasted 24-36 hours". No treatment information was provided. This case was linked to MOD-2022-616432 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial expired on 30-JUN-2022 and initially stored on 29-Jul-2022 and then administered on 01-AUG-2022; No adverse event; 1st Patient received expired booster doses after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st Patient received expired booster doses after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vial expired on 30-JUN-2022 and initially stored on 29-Jul-2022 and then administered on 01-AUG-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1st Patient received expired booster doses after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 30-JUN-2022 and initially stored on 29-Jul-2022 and then administered on 01-AUG-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1st Patient received expired booster doses after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vial expired on 30-JUN-2022 and initially stored on 29-Jul-2022 and then administered on 01-AUG-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (1st Patient received expired booster doses after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vial expired on 30-JUN-2022 and initially stored on 29-Jul-2022 and then administered on 01-AUG-2022).    This case for patient 1 of 8 patients. No concomitant medication information were given. Vial was initially stored in the refrigerator. Thawed on 29th JUL 2022 and kept in the refrigerator. Vial doesn't undergo any temperature excursions. Patient received booster dose. Reporter stated that patient was not pregnant. No treatment information were given.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022; No adverse event; Patient received expired booster dose after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022).    No concomitant medication was reported.  The vial was thawed on 29-Jul-2022 and kept in the refrigerator.  The vial did not undergo any temperature excursion.  No treatment medication was provided.  This case contains information for the 2nd of 8 patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 7 Patients received expired booster doses after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 Patients received expired booster doses after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 Patients received expired booster doses after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 Patients received expired booster doses after manufacturer date of expiry) 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 (7 Patients received expired booster doses after manufacturer date of expiry).    Concomitant medications was not provided by the reporter.  Patients received expired booster doses after manufacturer date of expiry. On 29JUL2022 the vail thawed and kept in the refrigerator. The vial doesn't undergo any temperature excursions.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4th Patient received expired booster doses after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4th Patient received expired booster doses after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4th Patient received expired booster doses after manufacturer date of expiry) 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 (4th Patient received expired booster doses after manufacturer date of expiry). It was reported that patient was not pregnant. Concomitant medication details were not reported by the reporter. Patient received booster dose. On 29-JUL-2022 vial was initially thawed and stored in refrigerator. Vial did not undergo any temperature excursions. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022; No Adverse event; 5th Patient received expired booster doses after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5th Patient received expired booster doses after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5th Patient received expired booster doses after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5th Patient received expired booster doses after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (5th Patient received expired booster doses after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022).    No concomitant medications were reported. Vial initially was thawed on 29-JUL-2022 and kept in the refrigerator. Patient received booster dose. The patient was not pregnant. Vial did not undergo any temperature excursions. This case contains information for the 5th of 8 adult patients described by the reporter. No treatment information was provided.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: No adverse event; Immunization to  pediatric patient. They had the vaccine administered in the upper bicep area; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Immunization to  pediatric patient. They had the vaccine administered in the upper bicep area) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient had any allergies to medications, food and other products.  It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19.  It was unknown whether the patient had both Acute and Chronic illnesses at the time of vaccination.  It was unknown whether any other vaccines were given to patient within 1 month prior to Moderna COVID-19.     On 23-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Immunization to  pediatric patient. They had the vaccine administered in the upper bicep area). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Immunization to  pediatric patient. They had the vaccine administered in the upper bicep area) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Immunization to  pediatric patient. They had the vaccine administered in the upper bicep area).    Concomitant drugs were not reported. Patient received the vaccine on upper bicep area. It was unknown whether the event cause the patient to seek medical care. It was unknown whether the patient experienced a similar event in the past. Treatment details were not given.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022; No adverse event; Patient received expired booster doses after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired booster doses after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired booster doses after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired booster doses after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired booster doses after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022 and was stored in refrigerator on 29-JUL-2022, Dose was admininstered on 01-AUG-2022).    No concomitant medication was reported.  The patient received booster dose  The vial was thawed on 29-Jul-2022 and kept in the refrigerator.  The vial did not undergo any temperature excursion.  No treatment medication was provided.  This case contains information for the 6th of 8 patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vail expired on 30-Jun-2022, Thawed on 29-Jul-2022 and kept in the refrigerator.; No adverse event; Patient received expired booster dose after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022, Thawed on 29-Jul-2022 and kept in the refrigerator.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022, Thawed on 29-Jul-2022 and kept in the refrigerator.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022, Thawed on 29-Jul-2022 and kept in the refrigerator.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired booster dose after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vail expired on 30-Jun-2022, Thawed on 29-Jul-2022 and kept in the refrigerator.).    No concomitant medications were reported.  Patient received booster dose.   Vial did not undergo any temperature excursions.  No treatment information was provided.  This case contains information for the 7th of 8 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022; no adverse event; Patient received expired full dose after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired full dose after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 01-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired full dose after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired full dose after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired full dose after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial expired on 30-Jun-2022, thawed on 29-Jun-2022 and kept in the refrigerator and was administered on 01-Aug-2022).    No concomitant medications was reported. It was reported that 8 adult patients received the vaccine (7 Adult boosters and 1 adult full dose) on 01-Aug-2022. This case contains information for the 1 adult full dose of total 8 adult patients described by the reporter. The vial was initially stored in the refrigerator was thawed on 29JUL2022 and kept in the refrigerator. The vial did not vial undergo any temperature excursions. No treatment drug details was reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received 1st booster dose of the Moderna Covid 19 vaccine after its expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received 1st booster dose of the Moderna Covid 19 vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received 1st booster dose of the Moderna Covid 19 vaccine after its expiration 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 1st booster dose of the Moderna Covid 19 vaccine after its expiration date) 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 (Patient received 1st booster dose of the Moderna Covid 19 vaccine after its expiration date).    No concomitant medication was reported.  Date the vial was initially stored in the refrigerator: 19-Jul-2022.  On 19-Jul-2022, the patient received the first booster dose.  The vial did not undergo any temperature excursions.  No treatment information was reported.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Stiff neck; Vaccine caused sore arm for one to two days; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck) and PAIN IN EXTREMITY (Vaccine caused sore arm for one to two days) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck) and PAIN IN EXTREMITY (Vaccine caused sore arm for one to two days). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck) had not resolved and PAIN IN EXTREMITY (Vaccine caused sore arm for one to two days) had resolved.            Concomitant product use was not provided by the reporter.  The reporter's causality for the events of stiff neck and vaccine caused sore arm for one to two days with respect to Humira was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment information was provided.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Sinusitis
Clinical narrative: Allergy; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) and HYPERSENSITIVITY (Allergy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose once a day. In July 2022, the patient experienced SINUSITIS (Sinus infection). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergy). At the time of the report, SINUSITIS (Sinus infection) was resolving and HYPERSENSITIVITY (Allergy) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication was reported.  No treatment medication was reported.  The reporter's causality for the events of sinus infection with humira (adalimumab) was no reasonable possibility. The reporter's causality for the events of allergies was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Axillary mass, Chest discomfort, Pain
Clinical narrative: COVID vaccine reaction/Growth under armpit after COVID vaccine; Pain all over body; Anxiety; Tightness in chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain all over body), ANXIETY (Anxiety), CHEST DISCOMFORT (Tightness in chest) and AXILLARY MASS (COVID vaccine reaction/Growth under armpit after COVID vaccine) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 13-Jul-2022, the patient experienced PAIN (Pain all over body). In July 2022, the patient experienced ANXIETY (Anxiety) and CHEST DISCOMFORT (Tightness in chest). On an unknown date, the patient experienced AXILLARY MASS (COVID vaccine reaction/Growth under armpit after COVID vaccine). At the time of the report, PAIN (Pain all over body), ANXIETY (Anxiety), CHEST DISCOMFORT (Tightness in chest) and AXILLARY MASS (COVID vaccine reaction/Growth under armpit after COVID vaccine) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. The daily dose for Spikevax was provided as one in one once. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. The reporter causality for co-suspect upadacitinib and the events was not provided. No treatment medications were reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Paresthesia on the right side of the body; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Paresthesia on the right side of the body) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     Concurrent medical conditions included MS (MS involved only Optic Nerve. Did not have any other symptoms except the optic Nerve problem .) since 2012.    On 19-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PARAESTHESIA (Paresthesia on the right side of the body). At the time of the report, PARAESTHESIA (Paresthesia on the right side of the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications taken by the patient.  Patient did not had any another symptoms until patient received the Moderna vaccine.  Patient experienced the event less than 24 hours after vaccination.  No treatment medications were reported.