chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a booster dose of a vial whose lot number had already expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of a vial whose lot number had already expired) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of a vial whose lot number had already expired). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of a vial whose lot number had already expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  It was mentioned that reporter did not have the information on when the vial was initially stored in the refrigerator.   The 3 doses were from the Moderna COVID 19 Vaccine. It was confirmed that no temperature excursions were occurred.  Expiry date was on 8 Nov 2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Hypoaesthesia, Myalgia, Nausea
Clinical narrative: her face was a little numb / numbness; dizziness; head was spinning; shaking body; soreness in her arm; everything hurting; nauseous; ankles hurt; body aches; big rash on her arm in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (her face was a little numb / numbness), DIZZINESS (dizziness), VERTIGO (head was spinning), TREMOR (shaking body) and PAIN IN EXTREMITY (soreness in her arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076c21a, 046b21a and 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (her face was a little numb / numbness), DIZZINESS (dizziness), VERTIGO (head was spinning), TREMOR (shaking body), PAIN IN EXTREMITY (soreness in her arm), PAIN (everything hurting), NAUSEA (nauseous), ARTHRALGIA (ankles hurt), MYALGIA (body aches) and VACCINATION SITE RASH (big rash on her arm in the injection site). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (her face was a little numb / numbness), DIZZINESS (dizziness), VERTIGO (head was spinning), TREMOR (shaking body), PAIN IN EXTREMITY (soreness in her arm), PAIN (everything hurting), NAUSEA (nauseous), ARTHRALGIA (ankles hurt), MYALGIA (body aches) and VACCINATION SITE RASH (big rash on her arm in the injection site) outcome was unknown.            No concomitant medication information was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: NNI
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Tremor, Vaccination site rash, Vertigo
Clinical narrative: her face was a little numb / numbness; dizziness; head was spinning; shaking body; soreness in her arm; everything hurting; nauseous; ankles hurt; body aches; big rash on her arm in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (her face was a little numb / numbness), DIZZINESS (dizziness), VERTIGO (head was spinning), TREMOR (shaking body) and PAIN IN EXTREMITY (soreness in her arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076c21a, 046b21a and 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (her face was a little numb / numbness), DIZZINESS (dizziness), VERTIGO (head was spinning), TREMOR (shaking body), PAIN IN EXTREMITY (soreness in her arm), PAIN (everything hurting), NAUSEA (nauseous), ARTHRALGIA (ankles hurt), MYALGIA (body aches) and VACCINATION SITE RASH (big rash on her arm in the injection site). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (her face was a little numb / numbness), DIZZINESS (dizziness), VERTIGO (head was spinning), TREMOR (shaking body), PAIN IN EXTREMITY (soreness in her arm), PAIN (everything hurting), NAUSEA (nauseous), ARTHRALGIA (ankles hurt), MYALGIA (body aches) and VACCINATION SITE RASH (big rash on her arm in the injection site) outcome was unknown.            No concomitant medication information was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: NNI
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SEMAGLUTIDE (WEGOVY) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: At the site of the shot it's red; At the site of the shot it's  itchy; At the site of shot it's swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (At the site of the shot it's red), VACCINATION SITE PRURITUS (At the site of the shot it's  itchy) and VACCINATION SITE SWELLING (At the site of shot it's swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 013A21A and 020A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (At the site of the shot it's red), VACCINATION SITE PRURITUS (At the site of the shot it's  itchy) and VACCINATION SITE SWELLING (At the site of shot it's swollen). At the time of the report, VACCINATION SITE ERYTHEMA (At the site of the shot it's red), VACCINATION SITE PRURITUS (At the site of the shot it's  itchy) and VACCINATION SITE SWELLING (At the site of shot it's swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  Patient took Moderna booster  yesterday 08-Nov-2021. At the site of the shot, it's red, itchy, and swollen. She thinks that when she took the other two shots, she took Benadryl. She doesn't want to take anything she can't take, so she was calling to see if Benadryl was ok for her.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients were given a booster dose of an expired moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were given a booster dose of an expired moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were given a booster dose of an expired moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were given a booster dose of an expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Malaise, Nausea, Somnolence
Clinical narrative: Felt sick after second vaccine; Was very sleepy after second vaccine; No appetite after second vaccine; Nauseus after second vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick after second vaccine), SOMNOLENCE (Was very sleepy after second vaccine), DECREASED APPETITE (No appetite after second vaccine) and NAUSEA (Nauseus after second vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt sick after second vaccine), SOMNOLENCE (Was very sleepy after second vaccine), DECREASED APPETITE (No appetite after second vaccine) and NAUSEA (Nauseus after second vaccine). At the time of the report, MALAISE (Felt sick after second vaccine), SOMNOLENCE (Was very sleepy after second vaccine), DECREASED APPETITE (No appetite after second vaccine) and NAUSEA (Nauseus after second vaccine) had resolved.            No Concomitant medications were reported.  No Treatment information was reported.  Patient experienced adverse events for 24 to 38 hrs after 2nd dose.  This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected events of Malaise, Somnolence, Decreased Appetite, Adverse Event and Nausea. The events occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The event Nausea is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-380629, MOD-2021-381108 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Followup document received, contains no new information On 09-Nov-2021: Follow-up document received, contains no new information; Sender's Comments: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected events of Malaise, Somnolence, Decreased Appetite, Adverse Event and Nausea. The events occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The event Nausea is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Felt dizzy after the first Moderna Covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy after the first Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Felt dizzy after the first Moderna Covid-19 vaccine). At the time of the report, DIZZINESS (Felt dizzy after the first Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .  This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious, unexpected event of dizziness. The event occurred  on unknown date after first dose of mRNA 1273 vaccine. The rechallenge is unknown as the outcome of the event is unknown, although different events were reported after second dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-381102, MOD-2021-380629 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up document received, included dose number added and narrative updated. On 09-Nov-2021: Follow-up document received, and the document contains no new information.; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious, unexpected event of dizziness. The event occurred  on unknown date after first dose of mRNA 1273 vaccine. The rechallenge is unknown as the outcome of the event is unknown, although different events were reported after second dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Miserable; Joint pain; Fatigue; Headache; Muscle pain; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Miserable), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea). On 09-Nov-2021, the patient experienced FEELING ABNORMAL (Miserable). At the time of the report, FEELING ABNORMAL (Miserable), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was not sure if he had fever. The patient received first dose of Moderna COVID19 Vaccine on 01-Mar-2021 and second dose on 29-Feb-2021.  No concomitant and treatment drugs were reported.; Sender's Comments: This case concerns a 72-year-old, male patient, with no disclosed medical history, who experienced the non-serious, unexpected event of feeling abnormal and non-serious expected events of  arthralgia, fatigue, headache, myalgia, chills, and nausea. The events occurred  one day after booster dose of mRNA 1273 vaccine. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Miserable; Joint pain; Fatigue; Headache; Muscle pain; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Miserable), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea). On 09-Nov-2021, the patient experienced FEELING ABNORMAL (Miserable). At the time of the report, FEELING ABNORMAL (Miserable), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was not sure if he had fever. The patient received first dose of Moderna COVID19 Vaccine on 01-Mar-2021 and second dose on 29-Feb-2021.  No concomitant and treatment drugs were reported.; Sender's Comments: This case concerns a 72-year-old, male patient, with no disclosed medical history, who experienced the non-serious, unexpected event of feeling abnormal and non-serious expected events of  arthralgia, fatigue, headache, myalgia, chills, and nausea. The events occurred  one day after booster dose of mRNA 1273 vaccine. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Headache, Somnolence
Clinical narrative: Had heart fluttering; Drowsy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Had heart fluttering), SOMNOLENCE (Drowsy) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A, 021B21A and 017A21A/ 017F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Had heart fluttering), SOMNOLENCE (Drowsy) and HEADACHE (Headache). At the time of the report, CARDIAC FLUTTER (Had heart fluttering), SOMNOLENCE (Drowsy) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: The case was downgrade to non-serious since there is no information in the source document supporting that the event resulted in a persistent or permanent incapacity or meet the criteria to be medically significant and the patient did not seek medical attention.   This case was linked to MOD-2021-381126, MOD-2021-381125 (Patient Link).; Sender's Comments: The case was downgrade to non-serious since there is no information in the source document supporting that the event resulted in a persistent or permanent incapacity or meet the criteria to be medically significant and the patient did not seek medical attention.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is really sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 031A21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm is really sore). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 08-Nov-2021 for Pain in arm, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm is really sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient arm was really sore today (09-nov-2021) and took a Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow-up received: No new information added.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (heart flutters) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A, 017A21A/017F21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (heart flutters) (seriousness criterion medically significant) and HEADACHE (a headache). At the time of the report, CARDIAC FLUTTER (heart flutters) and HEADACHE (a headache) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided.  No treatment information was provided.  Company Comment: This case concerns a 56-year-old female patient with no known medical history, who experienced the serious, unexpected event of cardiac flutter and non-serious expected event of headache. The events occurred  on unknown date after second dose of mRNA 1273 vaccine. The rechallenge is unknown, patient reported headache after booster dose, but outcome of event headache after second dose is unknown. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report. Re-challenge of both first and second dose as unknown.   This case was linked to MOD-2021-381116, MOD-2021-381126, MOD-2021-381116 (Patient Link).; Sender's Comments: This case concerns a 56-year-old female patient with no known medical history, who experienced the serious, unexpected event of cardiac flutter and non-serious expected event of headache. The events occurred  on unknown date after second dose of mRNA 1273 vaccine. The rechallenge is unknown, patient reported headache after booster dose, but outcome of event headache after second dose is unknown. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site mass
Clinical narrative: a big lump on the side of her arm between the arm & breast; A bad headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a big lump on the side of her arm between the arm & breast) and HEADACHE (A bad headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (a big lump on the side of her arm between the arm & breast) and HEADACHE (A bad headache). At the time of the report, VACCINATION SITE MASS (a big lump on the side of her arm between the arm & breast) and HEADACHE (A bad headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported. Two lot no. given for booster dose were given as lot # 017A21A or 017F21A.   This case was linked to MOD-2021-381116 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Heart disease, unspecified and Aneurysm of artery of lower extremity. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for Lung disease, CELECOXIB (CELEXA [CELECOXIB]) and CLONAZEPAM (KLONOPIN) for Panic attacks, OXYGEN, TRIAMTERENE and CYANOCOBALAMIN (B-12) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore Arm). At the time of the report, MYALGIA (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported inhaler as concomitant medication. No treatment medications were reported    This case was linked to MOD-2021-038509 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste in their mouth; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in their mouth) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (metallic taste in their mouth). At the time of the report, DYSGEUSIA (metallic taste in their mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment were not reported.  It was reported the couple of people have complained about a metallic taste in their mouth after getting the Moderna COVID-19 vaccine. The doctor stated that it would go away on its own.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Got Pfizer as a 1st dose and Moderna as a 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Got Pfizer as a 1st dose and Moderna as a 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Autoimmune disorder.   On 07-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 07-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got Pfizer as a 1st dose and Moderna as a 2nd dose). On 07-Nov-2021, INTERCHANGE OF VACCINE PRODUCTS (Got Pfizer as a 1st dose and Moderna as a 2nd dose) had resolved.            Concomitant medications and treatment information were not provided by reporter.  Patient wants to know if patient should get a third one. Two weeks after the Pfzier dose, patient had a relapse with disease and landed in the ER. Patient thought this was related to the vaccine and that's why patient chose Moderna as a second dose.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick (after 2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick (after 2nd dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick (after 2nd dose)). At the time of the report, ILLNESS (Got sick (after 2nd dose)) outcome was unknown.            No concomitant drugs were reported. Treatment medication were not reported .   This case was linked to MOD-2021-381023, MOD-2021-381140 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin discolouration, Vaccination site bruising, Vaccination site erythema, Vaccination site swelling
Clinical narrative: left arm got hot/left arm got warm/upper left forearm got hot/left arm warmth gone; left arm got red/upper left forearm got red/left arm redness gone; left arm got swollen/upper left forearm got swollen/left arm swelling gone down; fever (went away quick); a good size black and blue mark; bruising of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (a good size black and blue mark), VACCINATION SITE BRUISING (bruising of the left arm), VACCINATION SITE WARMTH (left arm got hot/left arm got warm/upper left forearm got hot/left arm warmth gone), PYREXIA (fever (went away quick)) and VACCINATION SITE ERYTHEMA (left arm got red/upper left forearm got red/left arm redness gone) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced PYREXIA (fever (went away quick)). In November 2021, the patient experienced SKIN DISCOLOURATION (a good size black and blue mark) and VACCINATION SITE BRUISING (bruising of the left arm). On an unknown date, the patient experienced VACCINATION SITE WARMTH (left arm got hot/left arm got warm/upper left forearm got hot/left arm warmth gone), VACCINATION SITE ERYTHEMA (left arm got red/upper left forearm got red/left arm redness gone) and VACCINATION SITE SWELLING (left arm got swollen/upper left forearm got swollen/left arm swelling gone down). On 07-Nov-2021, VACCINATION SITE WARMTH (left arm got hot/left arm got warm/upper left forearm got hot/left arm warmth gone), VACCINATION SITE ERYTHEMA (left arm got red/upper left forearm got red/left arm redness gone) and VACCINATION SITE SWELLING (left arm got swollen/upper left forearm got swollen/left arm swelling gone down) had resolved. At the time of the report, SKIN DISCOLOURATION (a good size black and blue mark) and VACCINATION SITE BRUISING (bruising of the left arm) outcome was unknown and PYREXIA (fever (went away quick)) had resolved.            No Concomitant medications were reported  Patient reported that she had visited her physician on 05 NOV 2021, the doctor had her use cold compresses on her left arm and after a day it became significantly better. The reporter stated the doctor thinks the needle may have been inserted at an angle and caused the bruising of the left arm.   This case was linked to MOD-2021-381139, MOD-2021-381023 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: left arm got hot/left arm got warm/upper left forearm got hot/left arm warmth gone; left arm got red/upper left forearm got red/left arm redness gone; left arm got swollen/upper left forearm got swollen/left arm swelling gone down; fever (went away quick); a good size black and blue mark; bruising of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (a good size black and blue mark), VACCINATION SITE BRUISING (bruising of the left arm), VACCINATION SITE WARMTH (left arm got hot/left arm got warm/upper left forearm got hot/left arm warmth gone), PYREXIA (fever (went away quick)) and VACCINATION SITE ERYTHEMA (left arm got red/upper left forearm got red/left arm redness gone) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced PYREXIA (fever (went away quick)). In November 2021, the patient experienced SKIN DISCOLOURATION (a good size black and blue mark) and VACCINATION SITE BRUISING (bruising of the left arm). On an unknown date, the patient experienced VACCINATION SITE WARMTH (left arm got hot/left arm got warm/upper left forearm got hot/left arm warmth gone), VACCINATION SITE ERYTHEMA (left arm got red/upper left forearm got red/left arm redness gone) and VACCINATION SITE SWELLING (left arm got swollen/upper left forearm got swollen/left arm swelling gone down). On 07-Nov-2021, VACCINATION SITE WARMTH (left arm got hot/left arm got warm/upper left forearm got hot/left arm warmth gone), VACCINATION SITE ERYTHEMA (left arm got red/upper left forearm got red/left arm redness gone) and VACCINATION SITE SWELLING (left arm got swollen/upper left forearm got swollen/left arm swelling gone down) had resolved. At the time of the report, SKIN DISCOLOURATION (a good size black and blue mark) and VACCINATION SITE BRUISING (bruising of the left arm) outcome was unknown and PYREXIA (fever (went away quick)) had resolved.            No Concomitant medications were reported  Patient reported that she had visited her physician on 05 NOV 2021, the doctor had her use cold compresses on her left arm and after a day it became significantly better. The reporter stated the doctor thinks the needle may have been inserted at an angle and caused the bruising of the left arm.   This case was linked to MOD-2021-381139, MOD-2021-381023 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine of Moderna COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine of Moderna COVID-19) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine of Moderna COVID-19). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine of Moderna COVID-19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-378217 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow-up received contains non-significant information.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 1 expired dose was mistakenly given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes on 09-Nov-2021 the follow up information received on 09-Nov-2021 contains No New Information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Tinnitus
Clinical narrative: buzzing ears; weakness; feel headaches; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (buzzing ears), ASTHENIA (weakness) and HEADACHE (feel headaches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (buzzing ears), ASTHENIA (weakness) and HEADACHE (feel headaches). At the time of the report, TINNITUS (buzzing ears), ASTHENIA (weakness) and HEADACHE (feel headaches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient reported some side effects after the Moderna vaccine (both doses) 4 or 6 months ago. Patient stated that She does not remember exact date. Since the 1st dose she started to feel headaches, buzzing ears and weakness.  Concomitant medications were not reported. Treatment information was not reported.   This case was linked to MOD-2021-381184 (Patient Link).
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a refrozen dose of the vaccine; Patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a refrozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-381132 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 72 year-old, unknown gender patient with no relevant history, who experienced the unexpected events of .EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR  The event occurred with the booster dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Disorientation, Dizziness, Feeding disorder, Gastrointestinal disorder
Clinical narrative: She is not feeling good again today whenever she tries to eat, couldnt keep anything down; Couldn't eat; Next day, she was very sleepy; Starting Thursday night, she was very dizzy; Disoriented; On same day, she had little pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (She is not feeling good again today whenever she tries to eat, couldnt keep anything down), FEEDING DISORDER (Couldn't eat), SOMNOLENCE (Next day, she was very sleepy), DIZZINESS (Starting Thursday night, she was very dizzy) and DISORIENTATION (Disoriented) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DILTIAZEM, CLOPIDOGREL BISULFATE (PLAVIX), INSULIN LISPRO (HUMALOG), LOSARTAN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 03-Nov-2021, the patient experienced VACCINATION SITE PAIN (On same day, she had little pain at injection site). On 04-Nov-2021, the patient experienced SOMNOLENCE (Next day, she was very sleepy), DIZZINESS (Starting Thursday night, she was very dizzy) and DISORIENTATION (Disoriented). On 09-Nov-2021, the patient experienced GASTROINTESTINAL DISORDER (She is not feeling good again today whenever she tries to eat, couldnt keep anything down) and FEEDING DISORDER (Couldn't eat). On 07-Nov-2021, DIZZINESS (Starting Thursday night, she was very dizzy) and DISORIENTATION (Disoriented) had resolved. At the time of the report, GASTROINTESTINAL DISORDER (She is not feeling good again today whenever she tries to eat, couldnt keep anything down) and FEEDING DISORDER (Couldn't eat) had not resolved and SOMNOLENCE (Next day, she was very sleepy) and VACCINATION SITE PAIN (On same day, she had little pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: low (Low) sugar went down.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.