chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: patient died 48 hours later with Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (patient died 48 hours later with Moderna) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. No treatment information was provided by the reporter. Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced unexpected death, which occurred at an unknown time with regards to vaccination with mRNA-1273. It was reported that the patient died 48 hours after vaccination. No further information was provided. The cause of death is unknown, and it was not disclosed if an autopsy was done. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced unexpected death, which occurred at an unknown time with regards to vaccination with mRNA-1273. It was reported that the patient died 48 hours after vaccination. No further information was provided. The cause of death is unknown, and it was not disclosed if an autopsy was done. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event; patient received the bivalent Moderna booster instead of 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the bivalent Moderna booster instead of 2nd dose) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 19-Sep-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the bivalent Moderna booster instead of 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the bivalent Moderna booster instead of 2nd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the bivalent Moderna booster instead of 2nd dose).    No concomitant medication were reported. On an unknown date, patient received first dose of Moderna vaccine (batch number 0530322A) No treatment information was provided by the reporter.
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle spasms
Clinical narrative: Violent muscle spasms/Muscle spams that were like convulsions; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Violent muscle spasms/Muscle spams that were like convulsions) in an 86-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS74OC) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Sep-2022, the patient experienced MUSCLE SPASMS (Violent muscle spasms/Muscle spams that were like convulsions). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In September 2022, MUSCLE SPASMS (Violent muscle spasms/Muscle spams that were like convulsions) had resolved.            Patient took first dose of Moderna, batch no 024M204 on Feb-2021, second dose on 19Oct2021 with batch no. 004C21A, first booster dose on 12-JAN-2021 with batch no. 01LA21-2A, second booster dose on 22-FEB-2022 with unknown batch no. No concomitant information were reported by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Pyrexia
Clinical narrative: tired the next day; 99 temperature which lasted 1 night; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (99 temperature which lasted 1 night) and FATIGUE (tired the next day) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced PYREXIA (99 temperature which lasted 1 night). On 17-Sep-2022, the patient experienced FATIGUE (tired the next day). On 17-Sep-2022, PYREXIA (99 temperature which lasted 1 night) had resolved. At the time of the report, FATIGUE (tired the next day) had resolved. No allergies were reported. No concomitant medication information was provided. Lot number reported as AS7140C or A57140C (handwritten). No treatment information was provided.  Patient never had COVID+ test or diagnosis. Did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose #).   This case was linked to MOD-2022-648275, MOD-2022-648106, MOD-2022-648153 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Inappropriate schedule of product administration, Limb discomfort
Clinical narrative: 1st dose Feb 2021 and 2nd dose administered on Feb 24 2021; a reaction on her legs/some problems on her leg; a reaction on her legs/some problems on her leg; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (a reaction on her legs/some problems on her leg), LIMB DISCOMFORT (a reaction on her legs/some problems on her leg) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Feb 2021 and 2nd dose administered on Feb 24 2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced IMMUNISATION REACTION (a reaction on her legs/some problems on her leg) and LIMB DISCOMFORT (a reaction on her legs/some problems on her leg). On 24-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Feb 2021 and 2nd dose administered on Feb 24 2021). At the time of the report, IMMUNISATION REACTION (a reaction on her legs/some problems on her leg), LIMB DISCOMFORT (a reaction on her legs/some problems on her leg) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Feb 2021 and 2nd dose administered on Feb 24 2021) outcome was unknown.            Patient's height was reported as 5'2 or 3". Patient had no history relating to adverse event and acute and chronic illnesses at the time of vaccination. Patient never had Covid test and diagnosis. Patient did not receive other vaccines within one month prior to Moderna vaccine. No concomitant medications were reported. Patient went to ER but was not hospitalized. Patient had some problems on leg last year which she thought was due to her age. Patient was told to drink plenty of water. Patient did not experience similar event in the past.   This case was linked to MOD-2022-648164 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Polymers allergy, Pyrexia, Vaccination site erythema
Clinical narrative: believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.; 102 degree temperature all night; chills all night.; small red circle about the size of a 50 cent piece after her second dose.; This spontaneous case was reported by a patient and describes the occurrence of POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.), PYREXIA (102 degree temperature all night), CHILLS (chills all night.) and VACCINATION SITE ERYTHEMA (small red circle about the size of a 50 cent piece after her second dose.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 028L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism and Hypertension. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced PYREXIA (102 degree temperature all night), CHILLS (chills all night.) and VACCINATION SITE ERYTHEMA (small red circle about the size of a 50 cent piece after her second dose.). On an unknown date, the patient experienced POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.). At the time of the report, POLYMERS ALLERGY (believes that she had an allergic reaction to the Polyethylene Glycol in the Moderna Covid-19 vaccine.), PYREXIA (102 degree temperature all night), CHILLS (chills all night.) and VACCINATION SITE ERYTHEMA (small red circle about the size of a 50 cent piece after her second dose.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degree.         No treatment medication were provided.   This case was linked to MOD-2022-648146, MOD-2022-648281.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: No adverse Event; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; first dose of the Moderna Covid 19 Vaccine on 29-May-2021 then received a first dose of the Pfizer Covid 19 Vaccine on 23-Aug-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna Covid 19 Vaccine on 29-May-2021 then received a first dose of the Pfizer Covid 19 Vaccine on 23-Aug-2022) and NO ADVERSE EVENT (No adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2022, the patient received second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On 23-Aug-2022, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna Covid 19 Vaccine on 29-May-2021 then received a first dose of the Pfizer Covid 19 Vaccine on 23-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna Covid 19 Vaccine on 29-May-2021 then received a first dose of the Pfizer Covid 19 Vaccine on 23-Aug-2022) and NO ADVERSE EVENT (No adverse Event) outcome was unknown. Not Provided      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 (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna Covid 19 Vaccine on 29-May-2021 then received a first dose of the Pfizer Covid 19 Vaccine on 23-Aug-2022).    No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received first dose on Feb 2021, second dose on 19-Oct-2021, first booster on 12-Jan-2022 and second booster on 22-Feb-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on Feb 2021, second dose on 19-Oct-2021, first booster on 12-Jan-2022 and second booster on 22-Feb-2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01LA21-2A, 004C21A and 024M204) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on Feb 2021, second dose on 19-Oct-2021, first booster on 12-Jan-2022 and second booster on 22-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 (Patient received first dose on Feb 2021, second dose on 19-Oct-2021, first booster on 12-Jan-2022 and second booster on 22-Feb-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-648129 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash
Clinical narrative: Patient was miserable; Patient experienced a rash a week after her second booster; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient was miserable) and RASH (Patient experienced a rash a week after her second booster) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced FEELING ABNORMAL (Patient was miserable) and RASH (Patient experienced a rash a week after her second booster). At the time of the report, FEELING ABNORMAL (Patient was miserable) and RASH (Patient experienced a rash a week after her second booster) outcome was unknown.            No concomitant medication information was provided.  It was reported that the patient went to dermatologist. No treatment medication was provided.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 012A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-648563 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 012A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-648563 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Received expired Monovalent 2nd Booster  after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent 2nd Booster  after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M21A, 030L20A, 011A21A and 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent 2nd Booster  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 (Received expired Monovalent 2nd Booster  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 (Received expired Monovalent 2nd Booster  after manufacturer date of expiry).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 13-sep-2022. The size of the vail was 5.5 ml. The vial did not undergo any temperature excursions.  No treatment drug details were reported.    This case was linked to US-MODERNATX, INC.-MOD-2022-648567 (E2B Linked Report). This case was linked to MOD-2022-648574 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648567:MOD22-024255(Same Reporter)
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received first dose on 22-JAN-2021 and second dose on 04-MAR-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-JAN-2021 and second dose on 04-MAR-2021) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-JAN-2021 and second dose on 04-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 received first dose on 22-JAN-2021 and second dose on 04-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 received first dose on 22-JAN-2021 and second dose on 04-MAR-2021).    No concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-648567 (Linked Report). This case was linked to MOD-2022-648569 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648567:MOD22-024255 (Same Reporter)
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Intentional overdose, Vaccination site discharge
Clinical narrative: Some of the liquid came out; While administering the last dose, some of the liquid came out/ they put a little extra in the syringe just in case this happened; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCHARGE (Some of the liquid came out) and INTENTIONAL OVERDOSE (While administering the last dose, some of the liquid came out/ they put a little extra in the syringe just in case this happened) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 vaccination.     Patient did not have COVID positive test or diagnosis.  Concurrent medical conditions included Allergic to cats and Pollen allergy.    On 20-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Sep-2022, the patient experienced VACCINATION SITE DISCHARGE (Some of the liquid came out) and INTENTIONAL OVERDOSE (While administering the last dose, some of the liquid came out/ they put a little extra in the syringe just in case this happened). At the time of the report, VACCINATION SITE DISCHARGE (Some of the liquid came out) and INTENTIONAL OVERDOSE (While administering the last dose, some of the liquid came out/ they put a little extra in the syringe just in case this happened) outcome was unknown. The concomitant medication was not reported by reporter. On 13-Jan-2021, the patient received first dose of the Intramuscular Moderna COVID-19 vaccine for the indication COVID-19 vaccination. On 10-Feb-2021, the patient received second dose of the Moderna COVID-19 vaccine lot number 010M20A. On 04-Nov-2021, the patient received the first Moderna COVID-19 booster dose lot number 051F21A. It was reported that when patient was administered Bivalent vaccine on 20-Sep-2022 the last dose, some of the liquid came out. The pharmacist mentioned that they put a little extra in the syringe just in case if this happened. The treatment medication was not reported by reporter.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 16 yr old was given Moderna vaccine as a booster instead of Pfizer; 16 yr old was given Moderna vaccine as a booster instead of Pfizer; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr old was given Moderna vaccine as a booster instead of Pfizer), PRODUCT USE ISSUE (16 yr old was given Moderna vaccine as a booster instead of Pfizer) and NO ADVERSE EVENT (No adverse event) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr old was given Moderna vaccine as a booster instead of Pfizer), PRODUCT USE ISSUE (16 yr old was given Moderna vaccine as a booster instead of Pfizer) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr old was given Moderna vaccine as a booster instead of Pfizer), PRODUCT USE ISSUE (16 yr old was given Moderna vaccine as a booster instead of Pfizer) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 yr old was given Moderna vaccine as a booster instead of Pfizer) and PRODUCT USE ISSUE (16 yr old was given Moderna vaccine as a booster instead of Pfizer).    No concomitant products were reported.  It was reported that the patient was not immunocompromised.  No treatment drugs were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Hypersensitivity, Irritability
Clinical narrative: An allergic reaction to the booster shot; lymph nodes on neck/ lymph nodes behind ear; Skin was bright red where the patient got shot. It's 2 inches long and 2 inches wide; Fatigued; It's blown up, hot; The patient hasn't felt good all day; irritable; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (It's blown up, hot), FEELING ABNORMAL (The patient hasn't felt good all day), IRRITABILITY (irritable), HYPERSENSITIVITY (An allergic reaction to the booster shot) and LYMPHADENOPATHY (lymph nodes on neck/ lymph nodes behind ear) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (Sulfa).    On 20-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced FEELING HOT (It's blown up, hot), FEELING ABNORMAL (The patient hasn't felt good all day), IRRITABILITY (irritable), LYMPHADENOPATHY (lymph nodes on neck/ lymph nodes behind ear), VACCINATION SITE ERYTHEMA (Skin was bright red where the patient got shot. It's 2 inches long and 2 inches wide) and FATIGUE (Fatigued). On 20-Sep-2022, the patient experienced HYPERSENSITIVITY (An allergic reaction to the booster shot). At the time of the report, FEELING HOT (It's blown up, hot), FEELING ABNORMAL (The patient hasn't felt good all day), IRRITABILITY (irritable), HYPERSENSITIVITY (An allergic reaction to the booster shot), LYMPHADENOPATHY (lymph nodes on neck/ lymph nodes behind ear), VACCINATION SITE ERYTHEMA (Skin was bright red where the patient got shot. It's 2 inches long and 2 inches wide) and FATIGUE (Fatigued) outcome was unknown.            No concomitant medication was reported.  The patient received all shots of vaccine were Moderna and patient stated doesn't understand what happened after booster shot.   The patient never had COVID positive test or diagnosis.  No treatment medication was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema
Clinical narrative: An allergic reaction to the booster shot; lymph nodes on neck/ lymph nodes behind ear; Skin was bright red where the patient got shot. It's 2 inches long and 2 inches wide; Fatigued; It's blown up, hot; The patient hasn't felt good all day; irritable; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (It's blown up, hot), FEELING ABNORMAL (The patient hasn't felt good all day), IRRITABILITY (irritable), HYPERSENSITIVITY (An allergic reaction to the booster shot) and LYMPHADENOPATHY (lymph nodes on neck/ lymph nodes behind ear) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (Sulfa).    On 20-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced FEELING HOT (It's blown up, hot), FEELING ABNORMAL (The patient hasn't felt good all day), IRRITABILITY (irritable), LYMPHADENOPATHY (lymph nodes on neck/ lymph nodes behind ear), VACCINATION SITE ERYTHEMA (Skin was bright red where the patient got shot. It's 2 inches long and 2 inches wide) and FATIGUE (Fatigued). On 20-Sep-2022, the patient experienced HYPERSENSITIVITY (An allergic reaction to the booster shot). At the time of the report, FEELING HOT (It's blown up, hot), FEELING ABNORMAL (The patient hasn't felt good all day), IRRITABILITY (irritable), HYPERSENSITIVITY (An allergic reaction to the booster shot), LYMPHADENOPATHY (lymph nodes on neck/ lymph nodes behind ear), VACCINATION SITE ERYTHEMA (Skin was bright red where the patient got shot. It's 2 inches long and 2 inches wide) and FATIGUE (Fatigued) outcome was unknown.            No concomitant medication was reported.  The patient received all shots of vaccine were Moderna and patient stated doesn't understand what happened after booster shot.   The patient never had COVID positive test or diagnosis.  No treatment medication was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Patient received the bivalent booster as their first dose/she was supposed to get the primary series but got the booster.; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received the bivalent booster as their first dose/she was supposed to get the primary series but got the booster.) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 vaccination.     It was unknown if the patient had allergies to medications, food and other products. The patient had not COVID + test or diagnosis. The patient had no acute and chronic illnesses at the time of vaccination. It was unknown if the patient had received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On 19-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 19-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received the bivalent booster as their first dose/she was supposed to get the primary series but got the booster.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received the bivalent booster as their first dose/she was supposed to get the primary series but got the booster.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Patient received the bivalent booster as their first dose/she was supposed to get the primary series but got the booster.).    It was unknown if patient was taking medication.  The reporter wanted to know if the patient had to restart the vaccination and what happen for the next vaccination.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Maternal exposure during breast feeding
Clinical narrative: Possible AE; Patient was fully vaccinated with the Moderna vaccine during breastfeeding; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Possible AE) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient was fully vaccinated with the Moderna vaccine during breastfeeding) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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 (Possible AE) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient was fully vaccinated with the Moderna vaccine during breastfeeding). At the time of the report, IMMUNISATION REACTION (Possible AE) outcome was unknown and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient was fully vaccinated with the Moderna vaccine during breastfeeding) had resolved.  No concomitant and treatment medications were reported.  Patient was fully vaccinated with the Moderna COVID-19 vaccine and her baby got fully vaccinated as well.  It was reported that patient wanted to know if it was ok to receive the bivalent booster while breastfeeding.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Vaccine administrated via subcutaneously/administration error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administrated via subcutaneously/administration error) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administrated via subcutaneously/administration error) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administrated via subcutaneously/administration error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Subcutaneous), 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 (Vaccine administrated via subcutaneously/administration error).    No concomitant medications were reported. Patient received a bivalent booster but because of an administration error they missed the deltoid. No treatment details were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Feeling abnormal, Flushing
Clinical narrative: felt like she was on steroids; facial flush; increased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like she was on steroids), FLUSHING (facial flush) and BLOOD PRESSURE INCREASED (increased blood pressure) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunization.     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, the patient experienced FEELING ABNORMAL (felt like she was on steroids), FLUSHING (facial flush) and BLOOD PRESSURE INCREASED (increased blood pressure). The patient was treated with CLONIDINE at a dose of UNK UNK, q4h for a month. At the time of the report, FEELING ABNORMAL (felt like she was on steroids), FLUSHING (facial flush) and BLOOD PRESSURE INCREASED (increased blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Increased.         No concomitant medication were provided.   This case was linked to MOD-2022-648649 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypertension, Insomnia
Clinical narrative: couldn't sleep for days; increased sweating; had headache; increased blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep for days), HYPERHIDROSIS (increased sweating), HYPERTENSION (increased blood pressure) and HEADACHE (had headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high.    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, the patient experienced INSOMNIA (couldn't sleep for days), HYPERHIDROSIS (increased sweating), HYPERTENSION (increased blood pressure) and HEADACHE (had headache). At the time of the report, INSOMNIA (couldn't sleep for days), HYPERHIDROSIS (increased sweating) and HEADACHE (had headache) outcome was unknown and HYPERTENSION (increased blood pressure) had resolved.            Concomitant medications included medication for increased blood pressure. It was reported that patient had to double her blood pressure medication after her booster shot. No treatment information provided.   This case was linked to MOD-2022-648645.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: a little tired; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (a little tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 prophylaxis.     Concomitant products included FAMOTIDINE, ATORVASTATIN, ESCITALOPRAM and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced FATIGUE (a little tired). At the time of the report, FATIGUE (a little tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Medical History information was reported.  No treatment drug was reported.   This case was linked to MOD-2022-648680, MOD-2022-648682 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dermal cyst, Rash, Scar
Clinical narrative: skin on the arms and legs and the back of the shoulders breaks out with an itchy cyst; skin on the arms and legs and the back of the shoulders are scarred; The skin on arms and legs and the back of shoulders breaks out; This spontaneous case was reported by a patient and describes the occurrence of DERMAL CYST (skin on the arms and legs and the back of the shoulders breaks out with an itchy cyst), SCAR (skin on the arms and legs and the back of the shoulders are scarred) and RASH (The skin on arms and legs and the back of shoulders breaks out) in a  patient of an unknown age and gender 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 DERMAL CYST (skin on the arms and legs and the back of the shoulders breaks out with an itchy cyst), SCAR (skin on the arms and legs and the back of the shoulders are scarred) and RASH (The skin on arms and legs and the back of shoulders breaks out). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, DERMAL CYST (skin on the arms and legs and the back of the shoulders breaks out with an itchy cyst), SCAR (skin on the arms and legs and the back of the shoulders are scarred) and RASH (The skin on arms and legs and the back of shoulders breaks out) had not resolved.            No concomitant medications were reported.  The patient visited the physician and informed them about the patient's condition, and they only kept on giving the patient with a prescription strength hydrocortisone, but the patient reported that the medication did not work. The patient reported that it had been more than a year since the events happened, as if the patient's body was trying to reject whatever constituent was there in the vaccine.  These cysts form sometimes daily or weekly. The patient had tried everything in order to reduce it.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) outcome was unknown.            No concomitant medications were reported.  It was reported the patient experienced migraine.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received  0.25ml  instead of 0.5ml for bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose).    No concomitant medications were reported. The age of patient was more than 18 years. The patient had received 2 primary and 2 monovalent booster of Moderna COVID-19 Vaccine. No treatment medications were reported.  This case contains information for the 2nd of 7 adult patients described by the reporter.