chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Inadvertently administered 0.25 of the Moderna bivalent booster dose (3rd dose); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Inadvertently administered 0.25 of the Moderna bivalent booster dose (3rd dose)) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient 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 fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 13-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Inadvertently administered 0.25 of the Moderna bivalent booster dose (3rd dose)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Inadvertently administered 0.25 of the Moderna bivalent booster dose (3rd 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 ACCIDENTAL UNDERDOSE (Inadvertently administered 0.25 of the Moderna bivalent booster dose (3rd dose)).    Concomitant product use was not provided by the reporter.  Patient received Moderna Covid-19 vaccines for the 4 previous doses.  Patient received 2nd booster dose on 26-Apr-2022 and no other information were available at the time of the report.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2022: Follow-up information received included reporter email address was updated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity
Clinical narrative: Fourth moderna vaccine caused fatigue; Allergy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergy) and FATIGUE (Fourth moderna vaccine caused fatigue) in a 38-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.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 28-Apr-2022, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In 2022, the patient experienced HYPERSENSITIVITY (Allergy). On an unknown date, the patient experienced FATIGUE (Fourth moderna vaccine caused fatigue). At the time of the report, HYPERSENSITIVITY (Allergy) had not resolved and FATIGUE (Fourth moderna vaccine caused fatigue) outcome was unknown.            No concomitant medication was provided.  It was reported that patient did not agree to contact physician.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient took first dose of Moderna  vaccine on 21-DEC-2020 intramuscularly, Second dose on 20-JAN-2021 and Third dose on 22-SEP-2021.  The reporter's causality for the event(s) of allergic condition with rinvoq(upadacitinib) was no reasonable possibility. the reporter's causality for the event(s) of fourth moderna vaccine dose caused fatigue was not provided.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-644983, MOD-2022-644994 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Influenza like illness, Injection site muscle weakness, Pyrexia, Vaccination site movement impairment
Clinical narrative: Can't raise my right arm; I have no strength in my right arm at all; I had flu-like symptoms; Was hot; I think I had a fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't raise my right arm), INJECTION SITE MUSCLE WEAKNESS (I have no strength in my right arm at all), INFLUENZA LIKE ILLNESS (I had flu-like symptoms), FEELING HOT (Was hot) and PYREXIA (I think I had a fever) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     No medical history reported.  It was unknown if the patient ever had COVID positive test or diagnosis.  Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Sep-2022, the patient experienced INFLUENZA LIKE ILLNESS (I had flu-like symptoms), FEELING HOT (Was hot) and PYREXIA (I think I had a fever). On 14-Sep-2022, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't raise my right arm) and INJECTION SITE MUSCLE WEAKNESS (I have no strength in my right arm at all). The patient was treated with PARACETAMOL (TYLENOL) on 10-Sep-2022 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't raise my right arm) and INJECTION SITE MUSCLE WEAKNESS (I have no strength in my right arm at all) had not resolved and INFLUENZA LIKE ILLNESS (I had flu-like symptoms), FEELING HOT (Was hot) and PYREXIA (I think I had a fever) had resolved.            On an unknown date the patient received first dose of Moderna vaccine, full dose with unknown lot number. On an unknown date the patient received second dose of Moderna vaccine, full dose with unknown lot number. On an unknown date the patient received first booster of Moderna vaccine, booster dose with unknown lot number. On an unknown date the patient received second booster of Moderna vaccine, booster dose with unknown lot number. Patient reported no side effects from the previously administered four doses of Moderna vaccines.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-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) .25 milliliter. On 14-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL) 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 ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL).    No relevant concomitant medications were reported. It was reported that patient did not report any AEs after the vaccine was administered. Treatment medication was not provided by the reporter.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Accidentally administered with 0.25 mL of bivalent booster instead of 0.5 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Accidentally administered with 0.25 mL of bivalent booster instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) in an 88-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-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) .25 milliliter. On 14-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Accidentally administered with 0.25 mL of bivalent booster instead of 0.5 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Accidentally administered with 0.25 mL of bivalent booster instead of 0.5 mL) 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 ACCIDENTAL UNDERDOSE (Accidentally administered with 0.25 mL of bivalent booster instead of 0.5 mL).    No concomitant information provided. Patient had not reported any adverse events after the vaccine was administered. No treatment information provided.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Accidentally administered dose of 0.25 mL instead of 0.5 mL of the Moderna COVID-19 Vaccine, Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Accidentally administered dose of 0.25 mL instead of 0.5 mL of the Moderna COVID-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-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) .25 milliliter. On 14-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Accidentally administered dose of 0.25 mL instead of 0.5 mL of the Moderna COVID-19 Vaccine, Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Accidentally administered dose of 0.25 mL instead of 0.5 mL of the Moderna COVID-19 Vaccine, Bivalent) 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 ACCIDENTAL UNDERDOSE (Accidentally administered dose of 0.25 mL instead of 0.5 mL of the Moderna COVID-19 Vaccine, Bivalent).    No concomitant medications were reported.  It was reported that the HCP (Healthcare professional) accidentally administered doses of 0.25 mL instead of 0.5 mL of the Moderna COVID-19 Vaccine, Bivalent. Patient did not reported any adverse events after the vaccine was administered.  No treatment information was reported.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Received a Toddler dose for 2nd booster/Not sure if received the toddler dose from a Bivalent vial for 2nd booster/Not sure if received the toddler dose from a Monovalent Toddler vial for 2nd booster; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received a Toddler dose for 2nd booster/Not sure if received the toddler dose from a Bivalent vial for 2nd booster/Not sure if received the toddler dose from a Monovalent Toddler vial for 2nd booster) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male 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.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (Patient received 2 primary Pfizer COVID-19 vaccines.). Past adverse reactions to the above products included No adverse reaction with Pfizer COVID-19 vaccine.    On 13-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 13-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Received a Toddler dose for 2nd booster/Not sure if received the toddler dose from a Bivalent vial for 2nd booster/Not sure if received the toddler dose from a Monovalent Toddler vial for 2nd booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received a Toddler dose for 2nd booster/Not sure if received the toddler dose from a Bivalent vial for 2nd booster/Not sure if received the toddler dose from a Monovalent Toddler vial for 2nd booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.  On 15-Dec-2021, the patient received third dose of First Moderna Booster(unknown route) 1 dosage form with the lot no.020F21A.  On 13-Sep-2022, the patient received second Moderna booster dose.  Treatment information was not provided.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Granuloma, Incorrect route of product administration
Clinical narrative: granuloma; was put in, not into the entire muscle, that is more or less was subcutaneous; This spontaneous case was reported by a pharmacist and describes the occurrence of GRANULOMA (granuloma) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was put in, not into the entire muscle, that is more or less was subcutaneous) in a 45-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 prophylaxis.     No Medical History information was reported.    On 12-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 12-Sep-2022, the patient experienced GRANULOMA (granuloma) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was put in, not into the entire muscle, that is more or less was subcutaneous). At the time of the report, GRANULOMA (granuloma) had not resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was put in, not into the entire muscle, that is more or less was subcutaneous) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.  The doctor was extremely concerned that patient would not get a sufficient immune response from  an improperly administered injection and would like information as to whether or not patient can get her shot repeated.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Confusional state, Decreased appetite, Fatigue, Headache
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of CONFUSIONAL STATE (knocked us for a loop), NECK PAIN (Shoulder started getting sore, which went to their neck), PAIN (Achiness), DECREASED APPETITE (Loss of appetite/ They also agree it hit her harder) and MUSCLE SPASMS (Muscle spasms) in a 68-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. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Sep-2022 at 4:00 PM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Sep-2022, the patient experienced CONFUSIONAL STATE (knocked us for a loop), NECK PAIN (Shoulder started getting sore, which went to their neck), PAIN (Achiness), MUSCLE SPASMS (Muscle spasms), HEADACHE (Severe headaches), MYALGIA (Feels achy all over) and FATIGUE (Tired). On 13-Sep-2022 at 9:00 PM, the patient experienced ARTHRALGIA (Shoulder started getting sore). On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite/ They also agree it hit her harder). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, CONFUSIONAL STATE (knocked us for a loop), NECK PAIN (Shoulder started getting sore, which went to their neck), PAIN (Achiness), DECREASED APPETITE (Loss of appetite/ They also agree it hit her harder), MUSCLE SPASMS (Muscle spasms), ARTHRALGIA (Shoulder started getting sore), HEADACHE (Severe headaches), MYALGIA (Feels achy all over) and FATIGUE (Tired) outcome was unknown. No concomitant medications were reported. Patient received the Moderna COVID-19 vaccine by intramuscular injection on 25-Feb-2021 (lot number 023M20A, expiration date unknown), 25-Mar-2021 (lot number 013A21A, expiration date unknown), 02-Nov-2021 (lot number 077C21B, expiration date unknown) and 03-Jun-2022 (lot number 056M21A, expiration date unknown). Patient had loss of appetite. They also agreed it hit patient harder. Patient had been taking Advil.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle spasms, Myalgia, Neck pain, Pain
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of CONFUSIONAL STATE (knocked us for a loop), NECK PAIN (Shoulder started getting sore, which went to their neck), PAIN (Achiness), DECREASED APPETITE (Loss of appetite/ They also agree it hit her harder) and MUSCLE SPASMS (Muscle spasms) in a 68-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. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Sep-2022 at 4:00 PM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Sep-2022, the patient experienced CONFUSIONAL STATE (knocked us for a loop), NECK PAIN (Shoulder started getting sore, which went to their neck), PAIN (Achiness), MUSCLE SPASMS (Muscle spasms), HEADACHE (Severe headaches), MYALGIA (Feels achy all over) and FATIGUE (Tired). On 13-Sep-2022 at 9:00 PM, the patient experienced ARTHRALGIA (Shoulder started getting sore). On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite/ They also agree it hit her harder). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, CONFUSIONAL STATE (knocked us for a loop), NECK PAIN (Shoulder started getting sore, which went to their neck), PAIN (Achiness), DECREASED APPETITE (Loss of appetite/ They also agree it hit her harder), MUSCLE SPASMS (Muscle spasms), ARTHRALGIA (Shoulder started getting sore), HEADACHE (Severe headaches), MYALGIA (Feels achy all over) and FATIGUE (Tired) outcome was unknown. No concomitant medications were reported. Patient received the Moderna COVID-19 vaccine by intramuscular injection on 25-Feb-2021 (lot number 023M20A, expiration date unknown), 25-Mar-2021 (lot number 013A21A, expiration date unknown), 02-Nov-2021 (lot number 077C21B, expiration date unknown) and 03-Jun-2022 (lot number 056M21A, expiration date unknown). Patient had loss of appetite. They also agreed it hit patient harder. Patient had been taking Advil.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: The 2nd booster made me sicker than a dog.; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (The 2nd booster made me sicker than a dog.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Brain inflammation: 325mg for aspirin (325mg for aspirin). Past adverse reactions to the above products included No adverse event with 325mg for aspirin. Concurrent medical conditions included Immunocompromised and Brain inflammation (on 325mg for aspirin.).   On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (The 2nd booster made me sicker than a dog.). At the time of the report, ILLNESS (The 2nd booster made me sicker than a dog.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was stated that patient was on steroids. Patient was not taking steroids anymore. Patient hadn't taken steroids for 3 weeks. Patient denies side effects from all doses of Moderna vaccines except 2nd booster. No treatment medication was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (tested positive for Covid) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-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 14-Sep-2022, the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2022, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Patient just underwent Moderna's bivalent Covid vaccination on 04-Sep-2022 and had tested positive for Covid on 14-Sep-2022. She has significant risk factors and takes immunosuppressive agents.  Caller is asking how soon can they take Paxlovid after taking the bivalent vaccine.  No treatment information was provided.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Gait disturbance, Illness, Mobility decreased
Clinical narrative: Sick / seriously ill; I couldnt walk; Leg wouldnt move; upset Stomach; Diarrhoea; Muscle pain; Fever; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick / seriously ill), GAIT DISTURBANCE (I couldnt walk), MOBILITY DECREASED (Leg wouldnt move), ABDOMINAL DISCOMFORT (upset Stomach) and DIARRHOEA (Diarrhoea) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick / seriously ill), GAIT DISTURBANCE (I couldnt walk), MOBILITY DECREASED (Leg wouldnt move), ABDOMINAL DISCOMFORT (upset Stomach), DIARRHOEA (Diarrhoea), MYALGIA (Muscle pain) and PYREXIA (Fever). At the time of the report, ILLNESS (Sick / seriously ill), GAIT DISTURBANCE (I couldnt walk), MOBILITY DECREASED (Leg wouldnt move), ABDOMINAL DISCOMFORT (upset Stomach), DIARRHOEA (Diarrhoea), MYALGIA (Muscle pain) and PYREXIA (Fever) had resolved.            No concomitant medication were provided.  It was reported that patient took all vaccines and boosters and felt sick after each dose of vaccine for atleast 3 to 4 hours. The last booster made patient seriously ill. Further it was reported that patient was told not to take any more boosters and should try another vaccine.    No treatment details were provided   This case was linked to MOD-2022-646099 (Patient Link).
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Sick / seriously ill; I couldnt walk; Leg wouldnt move; upset Stomach; Diarrhoea; Muscle pain; Fever; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick / seriously ill), GAIT DISTURBANCE (I couldnt walk), MOBILITY DECREASED (Leg wouldnt move), ABDOMINAL DISCOMFORT (upset Stomach) and DIARRHOEA (Diarrhoea) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick / seriously ill), GAIT DISTURBANCE (I couldnt walk), MOBILITY DECREASED (Leg wouldnt move), ABDOMINAL DISCOMFORT (upset Stomach), DIARRHOEA (Diarrhoea), MYALGIA (Muscle pain) and PYREXIA (Fever). At the time of the report, ILLNESS (Sick / seriously ill), GAIT DISTURBANCE (I couldnt walk), MOBILITY DECREASED (Leg wouldnt move), ABDOMINAL DISCOMFORT (upset Stomach), DIARRHOEA (Diarrhoea), MYALGIA (Muscle pain) and PYREXIA (Fever) had resolved.            No concomitant medication were provided.  It was reported that patient took all vaccines and boosters and felt sick after each dose of vaccine for atleast 3 to 4 hours. The last booster made patient seriously ill. Further it was reported that patient was told not to take any more boosters and should try another vaccine.    No treatment details were provided   This case was linked to MOD-2022-646099 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Received a 0.25mL dose of the Moderna Covid-19 Bivalent vaccine instead of a 0.5mL; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid-19 Bivalent vaccine instead of a 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid-19 Bivalent vaccine instead of a 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid-19 Bivalent vaccine instead of a 0.5mL) 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 ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid-19 Bivalent vaccine instead of a 0.5mL).    No concomitant medications were reported. The healthcare provider reported that they had mistakenly provided patients with 0.25 mL doses of the Moderna Covid-19 bivalent vaccine instead of 0.5 ml doses. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646302, US-MODERNATX, INC.-MOD-2022-646303 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646302:Patient 3 US-MODERNATX, INC.-MOD-2022-646303:Patient 2
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm/sore injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm/sore injection site arm.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 005C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm/sore injection site arm.). At the time of the report, VACCINATION SITE PAIN (sore arm/sore injection site arm.) outcome was unknown. No concomitant medications were reported. Patient does not remember which arm patient received the vaccine after first and second dose. Patient had sore arm after first dose. Patient had sore injection site arm after second dose and third dose (first booster dose). No treatment medications were reported. This case was linked to MOD-2022-646794 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: Loss of appetite for a couple hours that went away.; sore arm; Feeling kind of fatigued; feeling kind of bla; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling kind of bla), DECREASED APPETITE (Loss of appetite for a couple hours that went away.), PAIN IN EXTREMITY (sore arm) and FATIGUE (Feeling kind of fatigued) 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling kind of bla), DECREASED APPETITE (Loss of appetite for a couple hours that went away.), PAIN IN EXTREMITY (sore arm) and FATIGUE (Feeling kind of fatigued). At the time of the report, FEELING ABNORMAL (feeling kind of bla), PAIN IN EXTREMITY (sore arm) and FATIGUE (Feeling kind of fatigued) outcome was unknown and DECREASED APPETITE (Loss of appetite for a couple hours that went away.) had resolved.            No concomitant medications were reported.  It was reported that, patient received 4 doses of the Moderna vaccine and had only minor symptoms including: arm was sore, feeling kind of bla, and feeling kind of fatigued. Patient also had loss of appetite for a couple hours that went away.  No treatment medications were reported.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 65-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.     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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL) 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 ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL).    No concomitant information provided No treatment information provided HCP stated that they mistakenly provided patients with 0,25 mL doses of the Moderna Covid 19 Bivalent.   This case was linked to US-MODERNATX, INC.-MOD-2022-646299 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646299:Patient 3
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 75-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.     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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL) 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 ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL).    No concomitant drug was reported. Reporter stated that they mistakenly provided patients with 0,25 mL doses of the Moderna Covid 19 Bivalent. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646299, US-MODERNATX, INC.-MOD-2022-646302 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646299:Patient 1 US-MODERNATX, INC.-MOD-2022-646302:Patient 3
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient had severe side effects with the Moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Patient had severe side effects with the Moderna) in a 42-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy (Patient has a history of allergies) and Lung function abnormal.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had severe side effects with the Moderna). At the time of the report, IMMUNISATION REACTION (Patient had severe side effects with the Moderna) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. Patient was with only 50 percent lung function. Patient reacted very severely to the Moderna vaccines. No treatment information was provided.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Illness, Lymphadenopathy, Pyrexia, Status migrainosus
Clinical narrative: she was sick; status migrainosus; extremely debilitating; Had fever which comes and goes; she also experienced lymphadenopathy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she was sick), STATUS MIGRAINOSUS (status migrainosus), ASTHENIA (extremely debilitating), PYREXIA (Had fever which comes and goes) and LYMPHADENOPATHY (she also experienced lymphadenopathy) in a 65-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 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced ILLNESS (she was sick), STATUS MIGRAINOSUS (status migrainosus), ASTHENIA (extremely debilitating), PYREXIA (Had fever which comes and goes) and LYMPHADENOPATHY (she also experienced lymphadenopathy). At the time of the report, ILLNESS (she was sick), STATUS MIGRAINOSUS (status migrainosus), ASTHENIA (extremely debilitating), PYREXIA (Had fever which comes and goes) and LYMPHADENOPATHY (she also experienced lymphadenopathy) outcome was unknown. No concomitant medication were reported. Patient was sick since she had 2nd booster of Moderna vaccine with fever which comes and goes. No treatment medication were reported.  This case was linked to MOD-2021-012616, MOD-2022-646519 (Patient Link).   Reporter did not allow further contact.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Vaccination site pain, Vertigo
Clinical narrative: Felt like the room is spinning after her booster dose of the Moderna Covid-19  of balance/she has had episodes of the room spinning and feeling "off"; Patient says that her balance is off when she is walking.; patient complains of a sore left arm where the injection was; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (Felt like the room is spinning after her booster dose of the Moderna Covid-19  of balance/she has had episodes of the room spinning and feeling "off"), BALANCE DISORDER (Patient says that her balance is off when she is walking.) and VACCINATION SITE PAIN (patient complains of a sore left arm where the injection was) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-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 14-Sep-2022, the patient experienced BALANCE DISORDER (Patient says that her balance is off when she is walking.) and VACCINATION SITE PAIN (patient complains of a sore left arm where the injection was). On 15-Sep-2022, the patient experienced VERTIGO (Felt like the room is spinning after her booster dose of the Moderna Covid-19  of balance/she has had episodes of the room spinning and feeling "off"). At the time of the report, VERTIGO (Felt like the room is spinning after her booster dose of the Moderna Covid-19  of balance/she has had episodes of the room spinning and feeling "off"), BALANCE DISORDER (Patient says that her balance is off when she is walking.) and VACCINATION SITE PAIN (patient complains of a sore left arm where the injection was) outcome was unknown.            No concomitant medications were reported.  On 25-Apr-2021, the patient received first dose of Moderna COVID-19 vaccine (lot number: 048B21A) in unspecified arm, second dose on 23-May-2021 (lot number: 005C21A and expiry date: 22-Oct-2021) in unspecified arm and first monovalent booster on 29-nov-2021 (lot number: unknown) in left arm.  No treatment medications were reported.   This case was linked to MOD-2022-646300 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: just got the new Moderna booster and it felt like I got mosquito bites on my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (just got the new Moderna booster and it felt like I got mosquito bites on my arm) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) 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 VACCINATION SITE PAIN (just got the new Moderna booster and it felt like I got mosquito bites on my arm). At the time of the report, VACCINATION SITE PAIN (just got the new Moderna booster and it felt like I got mosquito bites on my arm) outcome was unknown.    No concomitant medications were reported. It was reported that, the patient got booster and it felt like mosquito bites on arm. It was unknown, if the patient had mosquito bite. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: pressure on my chest/like someone punched me in the sternum/punch kept pushing into my chest/it was just a flash; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (pressure on my chest/like someone punched me in the sternum/punch kept pushing into my chest/it was just a flash) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient never had COVID positive test or diagnosis.  Previously administered products included for Drug use for unknown indication: Pfizer (Dose Number: 1, Lot number: EL9266, Dose: unknown) on 16-Feb-2021, Pfizer (Dose Number: 2, Lot number: EN6206, Dose: unknown) on 09-Mar-2021, Pfizer (Dose Number: 3, First Booster dose, Lot number: FC3181, Dose: unknown) on 12-Sep-2021, shingles vaccine (shingles vaccine) in February 2022 and shingles vaccine (second singles in April or May). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer, shingles vaccine and shingles vaccine. Concurrent medical conditions included Drug allergy (sulfur allergy), Allergy (garlic allergy) and Arthritis.    On 08-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. In September 2022, the patient experienced CHEST DISCOMFORT (pressure on my chest/like someone punched me in the sternum/punch kept pushing into my chest/it was just a flash). In September 2022, CHEST DISCOMFORT (pressure on my chest/like someone punched me in the sternum/punch kept pushing into my chest/it was just a flash) had resolved.            Concomitant medication details were not reported by the reporter.  The patient had received second booster dose of Moderna COVID-19 vaccine on 10 Apr 2022, with lot number 048L21A and dose was unknown.  The patient stated that she had an unusual side effect after getting the bivalent vaccine. Patient stated that 36 hours after she got the vaccine, she felt that pressure on her chest like someone had punched her in the sternum and the punch kept pushing into her chest. That lasted for 5 seconds. Then 15-20 minutes later, she felt that again but felt much lighter. She does not seek medical attention because she only had two episodes that lasted no longer than 10 seconds. She stated that was just a flash.  The patient had not experienced a similar event in the past.   Treatment details was not reported by the reporter.