chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP stated no AEs were reported by patients after the vaccines were administered; Patient was administered the Moderna Covid 19 vaccine after use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna Covid 19 vaccine after use by date) and NO ADVERSE EVENT (HCP stated no AEs were reported by patients after the vaccines were administered) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna Covid 19 vaccine after use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (HCP stated no AEs were reported by patients after the vaccines were administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna Covid 19 vaccine after use by date) and NO ADVERSE EVENT (HCP stated no AEs were reported by patients after the vaccines were administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (HCP stated no AEs were reported by patients after the vaccines were administered) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna Covid 19 vaccine after use by date).    No concomitant medication was provided.  Beyond use date (BUD) was reported as 28 Aug 2022.  It was unknown whether the vial was initially stored in the refrigerator. It was unknown whether the vial underwent any temperature excursions.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2022: Live follow up received no new information.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; received the wrong booster/received booster from incorrect vial; got the pediatric 6 to 11 year old formulation; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (received the wrong booster/received booster from incorrect vial), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (received the wrong booster/received booster from incorrect vial) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (received the wrong booster/received booster from incorrect vial), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT (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 INCORRECT DOSE ADMINISTERED (received the wrong booster/received booster from incorrect vial) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (got the pediatric 6 to 11 year old formulation).    No concomitant medication were provided.  It was reported that the patient was were supposed to get a booster, but they got the pediatric 6 to 11 year old formulation. The box showed booster doses on the outside. The pharmacist reported that an HCP grabbed a vial of the vaccine for 6-11 year old and administered on 06-Sep-2022 to patient who was going for booster shot. The pharmacist reported that it was confusing because the vial states Moderna COVID-19 Vaccine for booster doses only. There was a purple border on the carton, but not on the vial. It did not mention an age group on the carton at all.  No treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-642008 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642008:(same reporter)
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: they got the pediatric 6 to 11 year old formulation; No adverse event; received the wrong booster/received booster from incorrect vial; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (they got the pediatric 6 to 11 year old formulation) and NO ADVERSE EVENT (No adverse event) in a 51-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial). On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (they got the pediatric 6 to 11 year old formulation) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (they got the pediatric 6 to 11 year old formulation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (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 WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (they got the pediatric 6 to 11 year old formulation).    No concomitant medication were provided.  It was reported that the patient was were supposed to get a booster, but they got the pediatric 6 to 11 year old formulation. The box says booster doses on the outside. The pharmacist reported that an HCP grabbed a vial of the vaccine for 6-11 year old's and administered on 06-Sep-2022 to patient who was going for booster shot. The pharmacist reported that it was confusing because the vial states Moderna COVID19 Vaccine for booster doses only. There was a purple border on the carton, but not on the vial. It doesn't mention an age group on the carton at all.  No treatment details were provided   This case was linked to US-MODERNATX, INC.-MOD-2022-642008 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642008:(same reporter)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 04-Sep-2022, the patient experienced UNDERDOSE (administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (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 UNDERDOSE (administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose).    Concomitant medication details were not reported by the reporter.  On 02-Mar-2021, patient received First dose of Moderna COVID-19 vaccine with batch number 002A21A.  On 30-Mar2021, patient received second dose  of Moderna COVID-19 vaccine with batch number 028A21A.  On 25-Oct-2021, patient received First booster  of Moderna COVID-19 vaccine dose with batch number 076C21A.  On 18-Apr-2022, patient received Second booster  of Moderna COVID-19 vaccine dose with batch number 001M21A.  A retired pediatric nurse practitioner reported that she got the bivalent booster dose of the Moderna Covid-19 vaccine last 04Sep2022. Patients were given 0.25ml instead of the 0.5ml dose. Vaccine provider called and informed patients that CDC recommended giving a full 0.5ml of the vaccine again instead of just 0.25.  Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP stated no AEs were reported by patients after the vaccines were administered; Patient was administered the Moderna Covid 19 vaccine after use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna Covid 19 vaccine after use by date) and NO ADVERSE EVENT (HCP stated no AEs were reported by patients after the vaccines were administered) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna Covid 19 vaccine after use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (HCP stated no AEs were reported by patients after the vaccines were administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna Covid 19 vaccine after use by date) and NO ADVERSE EVENT (HCP stated no AEs were reported by patients after the vaccines were administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (HCP stated no AEs were reported by patients after the vaccines were administered) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna Covid 19 vaccine after use by date).    No concomitant medication was reported.  beyond use date (BUD) reported as 28-Aug-2022.  It was unknown whether the vial was initially stored in the refrigerator. It was unknown whether the vial underwent any temperature excursions.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2022: Live follow up received no new information.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine 30 days past its beyond use date) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AF1416B) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine 30 days past its beyond use 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 Moderna Covid-19 vaccine 30 days past its beyond use 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 Moderna Covid-19 vaccine 30 days past its beyond use date). No concomitant medication was reported. On 05-Aug-2022, the vial was initially stored in the refrigerator. The dose was administered on 06-Sep-2022 from 9:15 to 9:45. Reportedly, 5 Pediatric patients received Moderna COVID-19 vaccine 30 days past its beyond use date. The vial did not undergo any temperature excursions. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2022-642057, US-MODERNATX, INC.-MOD-2022-642052, US-MODERNATX, INC.-MOD-2022-642059, US-MODERNATX, INC.-MOD-2022-642869 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2022: Live follow up received included, patient details and suspect product dosing details. Sender's Comments: US-MODERNATX, INC.-MOD-2022-642057: Same reporter; US-MODERNATX, INC.-MOD-2022-642052: Same reporter; US-MODERNATX, INC.-MOD-2022-642059: Same reporter; US-MODERNATX, INC.-MOD-2022-642869: Same reporter.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypersensitivity, Rash
Clinical narrative: Heat over my body; allergic reaction; Severe rash; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Heat over my body), HYPERSENSITIVITY (allergic reaction) and RASH (Severe rash) 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 FEELING HOT (Heat over my body), HYPERSENSITIVITY (allergic reaction) and RASH (Severe rash). At the time of the report, FEELING HOT (Heat over my body), HYPERSENSITIVITY (allergic reaction) and RASH (Severe rash) outcome was unknown.     No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-642450 (Patient Link).
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: He only had some arm soreness.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (He only had some arm soreness.) in a male patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (He only had some arm soreness.). At the time of the report, PAIN IN EXTREMITY (He only had some arm soreness.) outcome was unknown.            No concomitant product use was reported.   The patient received previous 2 doses of vaccine.  The patient had virtually no side effects with new strain. Patient was wondering if it was because of the mixed strains or a lower dose. In Sep-2022, the patient only had some arm soreness. Patient stated that his body was more used to the vaccine.  No treatment information was provided.   This case was linked to MOD-2022-642246, MOD-2022-642281 (Patient Link).   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event; Received Moderna Covid-19 vaccine, Bivalent injection in the back of her arm.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received Moderna Covid-19 vaccine, Bivalent injection in the back of her arm.) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     It was unknown whether the patient had medications, food and other products allergies.  It was unknown if patient ever had COVID positive test or diagnosis.  It was unknown whether the patient had history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination.     On 03-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Sep-2022, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received Moderna Covid-19 vaccine, Bivalent injection in the back of her arm.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received Moderna Covid-19 vaccine, Bivalent injection in the back of her arm.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (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 INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received Moderna Covid-19 vaccine, Bivalent injection in the back of her arm.).    No relevant concomitant medications were reported.   It was unknown whether patient received other vaccines within 1 month prior to Moderna COVID-19 vaccine.  It was unknown if adverse event cause patient to seek medical care.  It was unknown if the patient experienced a similar event in the past.  No treatment information was provided.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose 1 was received on 4-Feb-2021 and dose 2 on 25-Feb-2021; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was received on 4-Feb-2021 and dose 2 on 25-Feb-2021) and NO ADVERSE EVENT (No adverse event) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient was ever been diagnosed with/tested positive for COVID-19. Acute illness at the time of vaccination and chronic or long-standing health conditions were unknown.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was received on 4-Feb-2021 and dose 2 on 25-Feb-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was received on 4-Feb-2021 and dose 2 on 25-Feb-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was received on 4-Feb-2021 and dose 2 on 25-Feb-2021).    No concomitant medication information was reported. No treatment information was reported. No adverse event was reported.   This case was linked to MOD-2022-638098 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2022: Follow up received included non significant information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose 1 given on 4-feb-2021 and dose 2 given on 25-feb-2022; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 given on 4-feb-2021 and dose 2 given on 25-feb-2022) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 given on 4-feb-2021 and dose 2 given on 25-feb-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 given on 4-feb-2021 and dose 2 given on 25-feb-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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 given on 4-feb-2021 and dose 2 given on 25-feb-2022).    No concomitant medications were reported. No adverse events were reported. Patient's third dose date was reported as 4-Oct-2021. No treatment medications were reported.   This case was linked to MOD-2022-638101 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2022: Live Follow up contains no new information.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Lowback pain; BODY ACHES; ARM PAIN; FEVER; FELT TIRED; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lowback pain), MYALGIA (BODY ACHES), PAIN IN EXTREMITY (ARM PAIN), PYREXIA (FEVER) and FATIGUE (FELT TIRED) in a 46-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.    The patient's past medical history included Overmedication (3 years) from 01-Sep-2017 to 01-Mar-2021, Skin rash from 2017 to 01-Jan-2022 and COVID-19 (7 days) from 25-Mar-2021 to 01-Apr-2021. Concurrent medical conditions included Sulfonamide allergy (Sulfur allergy) and Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On 01-Sep-2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced MYALGIA (BODY ACHES), PAIN IN EXTREMITY (ARM PAIN), PYREXIA (FEVER) and FATIGUE (FELT TIRED). On an unknown date, the patient experienced BACK PAIN (Lowback pain). On 01-Jan-2022, MYALGIA (BODY ACHES), PAIN IN EXTREMITY (ARM PAIN), PYREXIA (FEVER) and FATIGUE (FELT TIRED) had resolved. At the time of the report, BACK PAIN (Lowback pain) outcome was unknown.            No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  The reporter's causality for the events of FELT TIRED, FEVER, BODY ACHES and ARM PAIN with HUMIRA(ADALIMUMAB) was not related whereas not reported with low back pain.   This case was linked to MOD-2022-642694 (Patient Link).
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient got administered with dose 1 on 9 Feb 2021 and dose 2 on 2 Mar 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got administered with dose 1 on 9 Feb 2021 and dose 2 on 2 Mar 2021) and NO ADVERSE EVENT (No adverse event) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown, if the patient was ever tested or diagnosed with COVID. It was unknown if the history was related to mentioned event and both Acute and Chronic illnesses at the time of vaccination. It was unknown that patient had chronic or long-standing health conditions.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got administered with dose 1 on 9 Feb 2021 and dose 2 on 2 Mar 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got administered with dose 1 on 9 Feb 2021 and dose 2 on 2 Mar 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got administered with dose 1 on 9 Feb 2021 and dose 2 on 2 Mar 2021).    It was unknown that patient had prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination or at the time of adverse event. It was unknown if patient experienced allergies (medications, food and other products). It was unknown if patient ever had COVID positive test or diagnosis. It was unknown if patient received other vaccines within 1 month prior to Moderna COVID-19 vaccine. It was unknown if adverse event cause patient to seek medical care. It was unknown if patient experienced similar event in past.   No concomitant medication was provided.  No treatment medication were provided.   This case was linked to MOD-2022-637964 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2022: Follow-up received contains non significant information.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received first dose of Moderna vaccine on 06-Feb-2021 and second dose of Moderna vaccine on 27-Feb-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 06-Feb-2021 and second dose of Moderna vaccine on 27-Feb-2021) and NO ADVERSE EVENT (No adverse event) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 06-Feb-2021 and second dose of Moderna vaccine on 27-Feb-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 06-Feb-2021 and second dose of Moderna vaccine on 27-Feb-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose of Moderna vaccine on 06-Feb-2021 and second dose of Moderna vaccine on 27-Feb-2021).    No concomitant medications were reported.  No treatment medication was reported.   This case was linked to MOD-2022-637980 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2022: Live follow up received contains no new information
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose 1 given on 22-feb-2021 and dose 2 given on 15-Mar-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 given on 22-feb-2021 and dose 2 given on 15-Mar-2021) and NO ADVERSE EVENT (No adverse event) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 given on 22-feb-2021 and dose 2 given on 15-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 given on 22-feb-2021 and dose 2 given on 15-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 given on 22-feb-2021 and dose 2 given on 15-Mar-2021).    No concomitant medications were reported.  No adverse events were reported.  Patient's third dose date was reported as 09-Nov-2021.  No treatment medications were reported.   This case was linked to MOD-2022-638072 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2022: Live Follow up contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Gastric disorder
Clinical narrative: STOMACH PROBLEMS; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC DISORDER (STOMACH PROBLEMS) in an adult male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced GASTRIC DISORDER (STOMACH PROBLEMS). At the time of the report, GASTRIC DISORDER (STOMACH PROBLEMS) outcome was unknown.            Concomitant product use was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not provided.  The reporter's causality for the event of STOMACH PROBLEMS was not provided for Humira.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient was administered with dose 1 on 22 Feb 2021 and dose 2 on 15 Mar 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered with dose 1 on 22 Feb 2021 and dose 2 on 15 Mar 2021) and NO ADVERSE EVENT (No adverse event) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown, if the patient was ever tested or diagnosed with COVID. It was unknown if the history was related to mentioned event and both Acute and Chronic illnesses at the time of vaccination. It was unknown that patient had chronic or long-standing health conditions.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered with dose 1 on 22 Feb 2021 and dose 2 on 15 Mar 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered with dose 1 on 22 Feb 2021 and dose 2 on 15 Mar 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered with dose 1 on 22 Feb 2021 and dose 2 on 15 Mar 2021).    It was unknown that patient had prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination or at the time of adverse event.  No treatment medication were reported.  It was reported that the patient did not experience any adverse events and it was unknown, that if patient took any medical care.   This case was linked to MOD-2022-638071 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2022: Follow-up received contains non significant information.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient administered an expired vaccine; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 001J21-2A, 029A21A, 039A21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022, received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022,  after starting mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  NDC number of dose received was reported as 80777-273-10.  The facility stated that the patient received the new omicron booster vaccine and that the dose was not expired. Patient provided the lot number and found out that the patient was administered an expired vaccine.   The patient did not experienced any side effects.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2022: Follow up received inarrative supplement updated.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: someone received moderna for the 1st dose and then the 2nd dose was given 3 weeks later (instead of at least 4 weeks later); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (someone received moderna for the 1st dose and then the 2nd dose was given 3 weeks later (instead of at least 4 weeks later)) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (someone received moderna for the 1st dose and then the 2nd dose was given 3 weeks later (instead of at least 4 weeks later)) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (someone received moderna for the 1st dose and then the 2nd dose was given 3 weeks later (instead of at least 4 weeks later)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (someone received moderna for the 1st dose and then the 2nd dose was given 3 weeks later (instead of at least 4 weeks later)).    No concomitant medication was reported.  Reportedly, patient received Moderna for the first dose and then the second dose was given 3 weeks later (instead of at least 4 weeks later).  No treatment information was provided.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Circumstance or information capable of leading to medication error, Product confusion
Clinical narrative: look very similar/could easily be confused; look very similar/could easily be confused; This is a spontaneous report received from contactable reporter(s) (Nurse, Pharmacist and Physician). Other Case identifier(s): 2022M1009764.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; adrenalin [epinephrine] (ADRENALIN [EPINEPHRINE]), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT CONFUSION (non-serious), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown" and all described as "look very similar/could easily be confused".  Additional information: Numerous mix-ups between epinephrine injection and the COVID-19 vaccine have been reported. According to the Centers for Disease Control and Prevention (CDC), Epinephrine injection should be readily available to treat anaphylactic reactions to the COVID-19 vaccines. Most of the mix-ups occurred between look-alike, predrawn syringes of epinephrine and the vaccine withheld. Also, ADRENALIN (epinephrine) vials from Pharmaceutical look very similar to the Pfizer-BioNTechCOVID-19 vaccine formulation for 12 years and older with the purple cap (withheld) and could easily be confused. Both vials are about the same size and shape, with purple caps and mostly black print on white labels. Vaccination sites should only stock epinephrine autoinjectors, which look different than predrawn vaccine syringes. With training, the autoinjectors are easy to use in an emergency. Doses of epinephrine and vaccine should be kept in different storage locations but close enough to vaccinators so they can be quickly retrieved when needed. Consider storing epinephrine autoinjectors in an anaphylaxis kit with a tear-off lock. Ideally, utilize barcode scanning of vaccines and epinephrine autoinjectors prior to administration.  The lot number for BNT162B2 was not provided and will be requested during follow up.  Follow-up (02Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Amendment: This follow up is being submitted to amend previously reported information: case reassessed as valid.
Age: 30.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2020 as dose 1, single (Batch/Lot number: unknown), on 20Dec2020 as dose 2, single (Batch/Lot number: unknown) and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 14Jan2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 14Jan2022, outcome "unknown". The action taken for adalimumab was unknown.  The reporter considered "drug ineffective" and "covid-19" related to BNT162b2.  Clinical Course: Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of COVID-19 with Humira (Adalimumab) was not provided. Causality for Pfizer Biontech COVID-19 Vaccine (TOZINAMERAN) (Injection): The reporter's causality for the event(s) of COVID-19 with Pfizer Biontech COVID-19 Vaccine was possible. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-Up (14Apr2022): Follow-up attempts are completed. No further information is expected.  Follow-up (06Sep2021): This is a solicited follow-up report based on the information received by Pfizer from Regulatory Authority. Updated information included: Product Tab (Administration date, Route and dose number) added. BNT162B2 recoded with license as per Booster Dose.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness cannot be ruled out.
Age: 37.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: gave pediatric booster instead
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Patient experienced erythema surrounding local injection site that presented approximately one day after vaccine was given (vaccine administered on 9/4).  Patient came in to pharmacy on 9/8 to make pharmacist aware.  At that time, there was still redness on left deltoid.  It was not worse from the initial onset.  It appeared to be slowly healing.
Age: 15.0
Sex: M
Vaccine: COVID19, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No reported adverse event.  2nd COVID vaccine from primary series was given on day 15 instead of waiting for 21 days as recommended by guidelines
Age: 26.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately post vaccination pt reported feeling dizzy. Pt assisted to the floor to lay down safely with legs elevated, pt was diaphoretic. Pt lost consciousness for about 5 seconds. Pt was AXoX3 once recovered. ice packs and water provided. Pt reported feeling better and was assisted to sit down position at which time they stated they felt good. Pt assisted to chair and was escorted to observation at 2:42 pm with steady gate and AXOX3 for an additional 30 min observation.  Pt reported having similar reaction when blood was drawn. At 3:14 pm patient left site reporting symptoms resolved. Pt educated on signs and symptoms to seek medical attention for and pt verbalized understanding.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Lymph node swelling and pain in left axilla
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syncope
Clinical narrative: Patient fainted.  Patient did not eat before vaccine appointment and reported being nervous. Patient did not get injured and was able to leave without medical assistance. Patient remained in pharmacy for about 30 minutes after fainting to recover.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular, Vomiting
Clinical narrative: Patient experienced a severe headache and vomiting approximately 5 hours after vaccination. After that, her regular-spaced monthly periods went completely haywire. One year later, her menses are not back to normal. She recently went to a gynecologist, who ordered an ultrasound on her lower abdomen.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient should not have been given the booster.  RPH should have waited for bivalent booster