chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: more fatigue after 3rd dose than the others; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (more fatigue after 3rd dose than the others) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (more fatigue after 3rd dose than the others). At the time of the report, FATIGUE (more fatigue after 3rd dose than the others) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-353605, MOD-2021-353900 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            No Concomitant medications were provided No treatment medications were provided.    This case was linked to MOD-2021-353899, MOD-2021-353605 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: Her friends had stronger side effects with the second dose; People get body aches; People get joint pains; People get fever; 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 VACCINATION COMPLICATION (Her friends had stronger side effects with the second dose), MYALGIA (People get body aches), ARTHRALGIA (People get joint pains) and PYREXIA (People get fever) 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, 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 VACCINATION COMPLICATION (Her friends had stronger side effects with the second dose), MYALGIA (People get body aches), ARTHRALGIA (People get joint pains) and PYREXIA (People get fever). At the time of the report, VACCINATION COMPLICATION (Her friends had stronger side effects with the second dose), MYALGIA (People get body aches), ARTHRALGIA (People get joint pains) and PYREXIA (People get fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination complication
Clinical narrative: Her husband had stronger side effects with the second dose; Little bit of body aches and muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Her husband had stronger side effects with the second dose) and MYALGIA (Little bit of body aches and muscle aches) in a male 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, the patient experienced VACCINATION COMPLICATION (Her husband had stronger side effects with the second dose) and MYALGIA (Little bit of body aches and muscle aches). At the time of the report, VACCINATION COMPLICATION (Her husband had stronger side effects with the second dose) and MYALGIA (Little bit of body aches and muscle aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: He had the same side effects as with the first two shots (which he had in February; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February) in an 87-year-old male 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. In February 2021, the patient experienced VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February). At the time of the report, VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-354097, MOD-2021-354098, MOD-2021-353213 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia, General physical health deterioration, Illness
Clinical narrative: started going downhill; sick; becoming slow; This spontaneous case was reported by a consumer and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (started going downhill) and ILLNESS (sick) 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.    In August 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 GENERAL PHYSICAL HEALTH DETERIORATION (started going downhill) (seriousness criterion death), ILLNESS (sick) (seriousness criterion death) and BRADYKINESIA (becoming slow). The patient died on an unknown date. The reported cause of death was started going downhill and Illness. It is unknown if an autopsy was performed. At the time of death, BRADYKINESIA (becoming slow) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Caller reports the vaccine was Poison and the talked to so many people who have loved ones that are dead. Caller reports patient was perfectly fine then noticed becoming slow and sick overtime but caller states patient did not want to tell her exactly how patient was feeling.  Caller says patientr's blood was on Moderna's hands. Caller did not want to provide any information on the adverse event and hung up on the agent.  This case concerns a female patient of unknown age, no relevant medical history disclosed (very limited information), who experienced the unexpected serious events of General physical health deterioration and illness with fatal outcome. The events occurred on unknown date after the second dose of Spikevax (Moderna COVID-19 vaccine), with fatal outcome occurring on unknown date. The rechallenge was not applicable as the events occurred after the second dose and the patient died. Very limited information regarding patient's  medical history and concurrent conditions is provided. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.   This case was linked to MOD-2021-354152 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This case concerns a female patient of unknown age, no relevant medical history disclosed (very limited information), who experienced the unexpected serious events of General physical health deterioration and illness with fatal outcome. The events occurred on unknown date after the second dose of Spikevax (Moderna COVID-19 vaccine), with fatal outcome occurring on unknown date. The rechallenge was not applicable as the events occurred after the second dose and the patient died. Very limited information regarding patient's  medical history and concurrent conditions is provided. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: started going downhill; illness
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: Had the same side effects as with the first two shots (which he had in February; He had the same side effects as with the first two shots (which he had in February; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February) and VACCINATION SITE PAIN (Had the same side effects as with the first two shots (which he had in February) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February). On an unknown date, the patient experienced VACCINATION SITE PAIN (Had the same side effects as with the first two shots (which he had in February). At the time of the report, VACCINATION COMPLICATION (He had the same side effects as with the first two shots (which he had in February) and VACCINATION SITE PAIN (Had the same side effects as with the first two shots (which he had in February) outcome was unknown.            No concomitant and treatment information provided.   This case was linked to MOD-2021-354077, MOD-2021-354098 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Received 3rd shot, but not immunocompromised; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (Received 3rd shot, but not immunocompromised) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 032M20A and 024M20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] and VITAMIN D NOS for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Received 3rd shot, but not immunocompromised). On 24-Sep-2021, OFF LABEL USE (Received 3rd shot, but not immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient case is crosslinked to MOD21-152897 She discloses that they are both overweight. Her son has asthma, and she has COPD and has two small nodules in the base of her right lung. No treatment medication information was provided
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Arm pain; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and MYALGIA (Arm sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 48F21A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol. Concurrent medical conditions included Thyroiditis and Vaginal infection. Concomitant products included LEVOFLOXACIN HEMIHYDRATE (LEVOFLOXACIN [LEVOFLOXACIN HEMIHYDRATE]), IBUPROFEN and LEVOTHYROXINE for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-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 PAIN IN EXTREMITY (Arm pain) and MYALGIA (Arm sore). At the time of the report, PAIN IN EXTREMITY (Arm pain) and MYALGIA (Arm sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  Atorvastatin 40 mg
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity
Clinical narrative: Arm was achy and warm for 24 hrs; Arm was achy and warm for 24 hrs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was achy and warm for 24 hrs) and FEELING HOT (Arm was achy and warm for 24 hrs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was achy and warm for 24 hrs) and FEELING HOT (Arm was achy and warm for 24 hrs). At the time of the report, PAIN IN EXTREMITY (Arm was achy and warm for 24 hrs) and FEELING HOT (Arm was achy and warm for 24 hrs) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-353625, MOD-2021-353625 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 Patients received an expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Patients received an expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Patients received an expired dose). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 Patients received an expired dose) 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 medications were reported. The vial was initially stored in the refrigerator on 15-sep-2021 and the vial did not undergo any temperature excursions.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Neck pain, Visual impairment
Clinical narrative: Aching in his neck; One time episode of seeing green dots on the television; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Aching in his neck), VISUAL IMPAIRMENT (One time episode of seeing green dots on the television) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced NECK PAIN (Aching in his neck), VISUAL IMPAIRMENT (One time episode of seeing green dots on the television) and HEADACHE (Headache). At the time of the report, NECK PAIN (Aching in his neck), VISUAL IMPAIRMENT (One time episode of seeing green dots on the television) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2021, Blood pressure measurement: increased (High) Increased.         Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-354331, MOD-2021-354332 (Patient Link).
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-355109, MOD-2021-354515 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired doses were administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses were administered) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses were administered). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired doses were administered) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given by reporter. No treatment medication was given by reporter.   This case was linked to MOD-2021-354462, MOD-2021-354659 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow-up received: Added Patient details.
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Nervous system disorder
Clinical narrative: nerve problems in left side; twitching in the eye; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (nerve problems in left side) and BLEPHAROSPASM (twitching in the eye) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (nerve problems in left side) and BLEPHAROSPASM (twitching in the eye). At the time of the report, NERVOUS SYSTEM DISORDER (nerve problems in left side) and BLEPHAROSPASM (twitching in the eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Mammogram abnormal
Clinical narrative: discretion about mark on the breast; This spontaneous case was reported by a consumer and describes the occurrence of MAMMOGRAM ABNORMAL (discretion about mark on the breast) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A, 029L20A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Patient reports she had breast cancer 20 years ago.) and Surgery. Concurrent medical conditions included Immunocompromised.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-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 MAMMOGRAM ABNORMAL (discretion about mark on the breast). At the time of the report, MAMMOGRAM ABNORMAL (discretion about mark on the breast) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: abnormal (abnormal) A discretion about a mark on the breast..         No concomitant medication was reported. No treatment was reported. Patient recently went for a mammogram, there was a discretion about a mark on the breast. Biopsy of breast was performed, results not provided.   This case was linked to MOD-2021-022507.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (The patient said that in December had breast cancer and had surgery). Concurrent medical conditions included Breast cancer (The patient said that in December had breast cancer and had surgery and radiation for it.). Concomitant products included METOPROLOL 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 MYALGIA (body aches). At the time of the report, MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-354379, MOD-2021-354380 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site arm after first Moderna Covid-19 dose; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm after first Moderna Covid-19 dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm after first Moderna Covid-19 dose). At the time of the report, VACCINATION SITE PAIN (sore injection site arm after first Moderna Covid-19 dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported by the reporter, No treatment medication were reported by the reporter.   This case was linked to MOD-2021-354302, MOD-2021-354332 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site arm after second Moderna Covid-19 dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm after second Moderna Covid-19 dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shot.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm after second Moderna Covid-19 dose). At the time of the report, VACCINATION SITE PAIN (sore injection site arm after second Moderna Covid-19 dose) outcome was unknown.            It was reported that the patient received a flu shot and asked the nurse if she had the Moderna booster dose. The patient received his third full dose of the Moderna Covid-19 vaccine on 29-Sep-2021 with lot number 021C21A.  Concomitant medications were not reported. No treatment information was reported.   This case was linked to MOD-2021-354302, MOD-2021-354331 (Patient Link).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Local reaction on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Local reaction on the arm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, LEVOTHYROXINE, PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE]), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), LORAZEPAM (ATIVAN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE REACTION (Local reaction on the arm). At the time of the report, VACCINATION SITE REACTION (Local reaction on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were reported.   This case was linked to MOD-2021-354362 (Patient Link).
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Incorrect product storage; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Incorrect product storage) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Incorrect product storage). On 06-Oct-2021, PRODUCT STORAGE ERROR (Incorrect product storage) 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 medications were reported.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from vial more than 30 days refrigerated; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vial more than 30 days refrigerated) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vial more than 30 days refrigerated). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vial more than 30 days refrigerated) had resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow up received contains significant information. Added patient details, start date of drug.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: one patient received expired doses; 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 (one patient received expired doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (one patient received expired doses). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (one patient received expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter has updated that expired vaccine administration was done in single patient, which was previously stated as administration in two person. Concomitants were not provided. Treatment was not given.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow up received on 18-oct-2021 contains non significant information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itch in the injection site; Redness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (Itch in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site). The patient was treated with ALCOHOL for Itchy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itch in the injection site) and VACCINATION SITE ERYTHEMA (Redness in the injection site) outcome was unknown.            Patient took unknown concomitant medication for blood pressure.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Off label use
Clinical narrative: very fatigued/very exhausted; Got the 3rd dose without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very fatigued/very exhausted) and OFF LABEL USE (Got the 3rd dose without being immunocompromised) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, PROPRANOLOL, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), LORAZEPAM (ATIVAN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 12-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced OFF LABEL USE (Got the 3rd dose without being immunocompromised). On 13-Sep-2021, the patient experienced FATIGUE (very fatigued/very exhausted). On 12-Sep-2021, OFF LABEL USE (Got the 3rd dose without being immunocompromised) had resolved. At the time of the report, FATIGUE (very fatigued/very exhausted) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-354336 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Product dose omission issue, Pyrexia
Clinical narrative: chills; fever; first dose > 25 days ago; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and PRODUCT DOSE OMISSION ISSUE (first dose > 25 days ago) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (she had COVID really badly and it took her 5 weeks to get off and lost lot of her hair.) on 14-Jan-2021. Concurrent medical conditions included Antiphospholipid syndrome (Also known as Hughes disease, which is a sick blood disease) and Drug allergy (She does take warfarin since March 2019 because she is allergic to all heparin products).    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 25 days ago). On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Chills and Fever, at an unspecified dose and frequency. On 27-Apr-2021, PRODUCT DOSE OMISSION ISSUE (first dose > 25 days ago) had resolved. At the time of the report, CHILLS (chills) and PYREXIA (fever) 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.   No concomitant medications was reported.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: Arm swelled up; Lymph nodes swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled up) and LYMPHADENOPATHY (Lymph nodes swelled up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PERIPHERAL SWELLING (Arm swelled up) and LYMPHADENOPATHY (Lymph nodes swelled up). At the time of the report, PERIPHERAL SWELLING (Arm swelled up) had resolved and LYMPHADENOPATHY (Lymph nodes swelled up) had not resolved.            Patient arm swelled up- 3 days later his lymph nodes swelled up and up. Patient arm swelling went away but lymph nodes are still swollen. Patient declined to share any other information.  No concomitant medications were provided. No treatment medications were provided   Reporter did not allow further contact
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose administered from a vial that was greater then 12 hours post puncture at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (dose administered from a vial that was greater then 12 hours post puncture at room temperature) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (dose administered from a vial that was greater then 12 hours post puncture at room temperature). On 07-Oct-2021, PRODUCT STORAGE ERROR (dose administered from a vial that was greater then 12 hours post puncture at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported. Pharmacist was unable to provide that at time of call if this was each patients first or second dose.   This case was linked to MOD-2021-354712, MOD-2021-354432, MOD-2021-354517 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Interchange of vaccine products
Clinical narrative: Very upset and "is freaking out"; Received Moderna as a second dose after receiving Pfizer as a first; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Very upset and "is freaking out") and INTERCHANGE OF VACCINE PRODUCTS (Received Moderna as a second dose after receiving Pfizer as a first) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (Batch No:30130BA andDose-1) on 17-Sep-2021.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Moderna as a second dose after receiving Pfizer as a first). On an unknown date, the patient experienced FEELING ABNORMAL (Very upset and "is freaking out"). On 15-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (Received Moderna as a second dose after receiving Pfizer as a first) had resolved. At the time of the report, FEELING ABNORMAL (Very upset and "is freaking out") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in December 2020, Surgery in December 2020 and Radiation therapy in December 2020. Concomitant products included METOPROLOL for an unknown indication.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.            Patient also use other concomitant products along with metoprolol.  Treatment information was not provided.   This case was linked to MOD-2021-354326, MOD-2021-354380 (Patient Link).
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (expired vaccine administered beyond MFG exp. date) in a 75-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 001C21A) for COVID-19 immunization. No medical information reported. On Oct 13, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 13, 2021, patient administered expired product (expired vaccine  administered beyond MFG exp. date). On Oct 13, 2021, administered expired product (expired vaccine administered beyond MFG exp. date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter stated this was the second dose but not sure. This case linked to MOD-2021-354610 (patient link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Headache, Pain in extremity
Clinical narrative: Leg hurts; Chronically fatigued; Head hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg hurts), FATIGUE (Chronically fatigued) and HEADACHE (Head hurts) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031E21A) for COVID-19 vaccination.     .  Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ETANERCEPT (ENBREL) for Rheumatoid arthritis.    On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg hurts), FATIGUE (Chronically fatigued) and HEADACHE (Head hurts). At the time of the report, PAIN IN EXTREMITY (Leg hurts), FATIGUE (Chronically fatigued) and HEADACHE (Head hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination site pain
Clinical narrative: Arm was sore; Expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Arm was sore) and EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site joint pain
Clinical narrative: after receiving her first dose of the Moderna vaccine she experienced very noticeable increase in pain for the shoulder where she received the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE JOINT PAIN (after receiving her first dose of the Moderna vaccine she experienced very noticeable increase in pain for the shoulder where she received the vaccine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shoulder discomfort.    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 VACCINATION SITE JOINT PAIN (after receiving her first dose of the Moderna vaccine she experienced very noticeable increase in pain for the shoulder where she received the vaccine). At the time of the report, VACCINATION SITE JOINT PAIN (after receiving her first dose of the Moderna vaccine she experienced very noticeable increase in pain for the shoulder where she received the vaccine) had resolved.        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.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-354449 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site left arm. for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site left arm. for 2 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site left arm. for 2 days). On 05-May-2021, VACCINATION SITE PAIN (Sore injection site left arm. for 2 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-354402 (Patient Link).